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 901 records · Page 50Linked to original sources

PubMed1981

Cyclophosphamide versus cyclophosphamide, methotrexate, and 5-fluorouracil in advanced prostatic cancer: a randomized trial.

Thirty-two evaluable patients with metastatic carcinoma of the prostate were entered into a prospective randomized trial comparing cyclophosphamide (CYC) with a combination of cyclophosphamide, methotrexate, and fluorouracil (CMF). Progressive disease after endocrine manipulation was noted in 97% (31/32) of patients before entry. Stable disease (S) was observed in 9 of 17 patients treated with CYC. One partial response (PR) and seven stable responses occurred in the 15 CMF patients. Median duration of stable response was 4.5 months for CYC and 4.5 months on CMF. Median survival of patients with PR and S receiving CYC was 10.1 and for CMF 8.8 months. Patients with progressive disease survived a median 1.7 and 2.6 months with CYC and CMF, respectively. Toxicity was moderate, and no deaths were attributable to sepsis or bleeding. Almost all patients in this study had bone lesions as the dominant site of disease; this made objective assessment of response difficult. There was no significant improvement in response conferred by the combination regimen. Although patients with metastatic prostatic cancer may benefit from chemotherapy, impressive clinical responses are uncommon.

Aged↗

PubMed1991

Single agent therapy for infections in cancer patients: a prospective randomized trial comparing three extended-spectrum cephalosporins.

Three hundred and twenty patients were enrolled in a prospective randomized trial comparing cefoperazone, ceftizoxime and ceftriaxone for initial therapy of infectious episodes in cancer patients. Patients with neutropenia were excluded. In 286 evaluable episodes, the response rates associated with the three agents were 77% for cefoperazone, 70% for ceftizoxime and 72% for ceftriaxone, with no statistically significant differences between the three treatment groups. The overall response rate for all episodes of pneumonia (64%) was significantly lower than the response rate for all other infections (81%; p = 0.002), and the mortality associated with pneumonia (9%) was higher than that associated with all other episodes (2%; p = 0.01). Patients with infections due to gram-negative organisms responded well to all three agents, whereas patients with gram-positive infections responded more favorably to cefoperazone. Two different schedules of ceftriaxone were used. The clinical response did not differ significantly between patients receiving ceftriaxone once daily and those receiving it twice daily. The incidence of superinfection and relapse was extremely low and all three agents were well tolerated. It is concluded that extended spectrum cephalosporins are effective as single agents for the treatment of infections in cancer patients with adequate neutrophil counts.

Adolescent↗

PubMed1999

Macronutrient intake and change in mammographic density at menopause: results from a randomized trial.

To examine the effects of dietary fat intake on breast cancer risk, we are conducting a randomized trial of dietary intervention in women with extensive areas of radiologically dense breast tissue on mammography, a risk factor for breast cancer. Early results show that after 2 years on a low-fat, high-carbohydrate diet there is a significant reduction in area of density, particularly in women going through menopause. In women who went through menopause during the 2-year follow-up, the mean decreases in area of density and percentage of density in the intervention group were 11.0 cm2 and 11.0%, respectively, whereas the control group decreased 4.5 cm2 and 5.2%. The purpose of this analysis was to determine whether changes in intake of specific macronutrients could account for the observed reduction in breast density in these women. Differences between 2-year and baseline values of macronutrients (averaged over 3 nonconsecutive days of food intake) were calculated. We examined the effect of dietary variables, adjusted for changes in total calorie intake and weight and for family history of breast cancer, on changes in area of density and percentage of density using linear regression. Reduction in total or saturated fat intake or cholesterol intake was significantly associated with decreased dense area (p < or = .004). The most significant dietary variable associated with reduction in percentage of density was reduction in dietary cholesterol intake (P = 0.001), although reducing saturated fat intake was of borderline significance (P = 0.05). The effect of the membership in the intervention and control groups on change in area of density or percentage of density was reduced by models that included changes in intake of any fat, or cholesterol, or carbohydrates. The observation of an effect of diet at menopause on breast density, a marker of increased risk of breast cancer, may be an indication that exposures at this time have an enhanced effect on subsequent risk.

Body Weight↗

PubMed1988

A randomized trial of intrapartum versus immediate postpartum treatment of women with intra-amniotic infection.

A randomized trial of intrapartum versus postpartum antibiotic treatment of women with intra-amniotic infection was conducted. Intra-amniotic infection was treated with ampicillin and gentamicin during labor (at the time of diagnosis) in 26 women and immediately after umbilical cord clamping in 19 women. Intrapartum treatment led to a lower incidence of neonatal sepsis (0 versus 21%; P = .03) and a shorter neonatal hospital stay (3.8 versus 5.7 days; P = .02) when compared with postpartum treatment. There were no significant differences in the microbiologic results, the gestational age, or the birth weight between the groups. Intrapartum-treated mothers had a shorter mean postpartum stay, a lower mean number of febrile days, and a lower mean peak postpartum temperature than did postpartum-treated mothers; these differences were all statistically significant (P = .05). The treatment of clinical intra-amniotic infection during labor results in improved outcome.

Adult↗

PubMed2001

Two-year follow-up results of a prospective randomized trial comparing hybrid laser prostatectomy with TURP in the treatment of big benign prostates.

OBJECTIVE: We compared conventional transurethral electroresection of the prostate (TURP) and hybrid laser treatment in patients with symptomatic bladder outflow obstruction caused by a benign prostate bigger than 40 ml. MATERIAL AND METHODS: Forty-six patients with symptomatic urodynamically confirmed outflow obstruction caused by benign prostate hyperplasia bigger than 40 ml were accepted to the prospective trial and were randomized to receive hybrid laser treatment or TURP. The hybrid laser technique involved initial non-contact Nd:YAG coagulation followed by contact Nd:YAG vaporization to open the prostatic urethra. Patients were re-assessed after 3, 6, 12 and 24 months. RESULTS: Of the 46 patients, 37 (80%) were available at the 24-month follow-up. The re-operation rate was 14.3% in the hybrid laser group and 8.3% in the TURP group. The decrease in DanPSS-1 symptom score from baseline at 24 months was 51.0% in the hybrid laser group (p<0.01) and 80.0% in the TURP group (p<0.001), with no statistically significant differences between the groups. Early improvement in objective urinary parameters of peak urinary flow rate and residual urinary volume showed deterioration in hybrid laser group during longer follow-up, whereas in TURP group the improvement of these variables was sustained. Comparison between groups showed TURP to be superior in peak urinary flow rate (p < 0.001) and residual urinary volume (p < 0.01) at the 24-month follow-up visit. CONCLUSIONS: Both hybrid laser treatment and TURP give good symptomatic relief lasting at least 2 years in the treatment of big obstructing prostates, but hybrid laser treatment is associated with a higher re-operation rate because of inadequate initial prostate tissue removal and with inferior outcome in objective urinary parameters compared with TURP.

Aged↗

PubMedDate not supplied

Dose-intensive weekly alternating chemotherapy for patients with small cell lung cancer: randomized trial, can it improve survival of patients with good prognostic factors?

We conducted a randomized trial of dose-intensive weekly alternating chemotherapy (CAV/PE-W) and standard alternating chemotherapy (CAV/PE) in small cell lung cancer (SCLC) patients with good prognostic factors. A total of 76 patients with SCLC was randomized. The CAV/PE-W consisted of 4 alternating cycles of cyclophosphamide: 500 mg/m2, doxorubicin: 30 mg/m2, and vincristine: 1 mg/m2 (day 1) and cisplatin: 50 mg/m2 (day 8) and etoposide: 75 mg/m2 (days 8 and 9). The CAV/PE consisted of 2 alternating cycles of cyclophosphamide: 800 mg/m2, doxorubicin: 50 mg/m2, and vincristine: 1.4 mg/m2 (day 1), cisplatin: 100 mg/m2 (day 22) and etoposide: 100 mg/m2 (days 22, 23 and 24). Eligibility criteria were no prior therapy, no active concomitant malignancy, ECOG PS of 0 or 1, age < or =75, adequate hematologic functions and no brain metastasis. The complete response (CR) rate for CAV/PE-W (14/38, 36.8%) was significantly higher than that for CAV/PE (6/38, 15.8%, chi2; p=0. 032). However, the response rate in patients on CAV/PE-W (36/38, 94. 7%) was not significantly higher than the rate for CAV/PE (31/38, 81. 6%, chi2; p=0.076). Progression-free survival for patients on CAV/PE-W was significantly longer than that of patients on CAV/PE (41.4 weeks vs. 21.3 weeks, log-rank; p=0.0007, generalized Wilcoxon; p=0.0034) as was overall median survival (67.0 weeks vs. 51.2 weeks, log-rank; p=0.028). Actual dose-intensity of CAV/PE-W was 1.74 times that of CAV/PE. Hematological toxicities were equally frequent and G-CSF contributes to treatment efficacy by allowing administration of dose-intensive chemotherapy. The CAV/PE-W achieved a higher CR rate and longer survival, than the CAV/PE.

Adult↗

PubMed2001

A multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery.

STUDY DESIGN: A prospective, randomized trial comparing Proceed, a gelatin-based hemostatic sealant (treatment), with Gelfoam-thrombin (control) in stopping intraoperative bleeding during spinal surgery. OBJECTIVES: To determine the effectiveness and safety of Proceed. SUMMARY OF BACKGROUND DATA: Proceed has been tested in animal models to determine its safety and effectiveness as a hemostatic agent. The current study was conducted under a Food and Drug Administration-approved Investigational Device Exemption to evaluate the effectiveness and safety of Proceed in humans. METHODS: For this study, 127 patients undergoing spinal surgery were randomized into either the treatment or control group after standard surgical means to control bleeding had failed. The bleeding site was evaluated at 1, 2, 3, 6, and 10 minutes after the hemostatic agent was applied. The application was considered successful if the bleeding stopped within 10 minutes. Follow-up evaluation was performed at 12 to 36 hours, then at 6 to 8 weeks after surgery. RESULTS: Proceed stopped bleeding in 98% of the patients (first bleeding site only) within 10 minutes, as compared with 90% of the control patients (P = 0.001). At 3 minutes, successful hemostasis had been achieved in 97% of the Proceed group, as compared with 71% of the control group (P = 0.0001). There was no difference in the adverse event profile between the two groups. CONCLUSIONS: A significantly larger number of bleeding sites had achieved hemostasis with Proceed than with Gelfoam-thrombin at 1, 2, and 3 minutes after application. Proceed was as safe as Gelfoam-thrombin when used for hemostasis during spinal surgery procedures.

Administration, Topical↗

PubMed2002

Quality of life in advanced non-small-cell lung cancer: results of a Southwest Oncology Group randomized trial.

PURPOSE: The main purpose of this paper is to present the results of a randomized trial comparing the effects of two chemotherapy regimens on the Quality of life (QOL) of patients with advanced non-small-cell lung cancer (NSCLC). Trials in advanced stage disease represent an important treatment context for QOL assessment. A second purpose of this paper is to examine methods for handling the level of missing data commonly observed in the advanced stage disease context. METHODS: Patients were randomized to receive cisplatin plus vinorelbine or carboplatin plus paclitaxel. The QOL of 222 patients was assessed with the Functional Assessment of Cancer Therapy-Lung (FACT-L) prior to randomization; follow-up assessments occurred at 13 and 25 weeks. Three methods were used to analyze the QOL data: (1) cross-sectional analysis of four patient categories (improved, stable, missing, and declined) based on changes in the FACT-L score, (2) a mixed linear model, and (3) a pattern mixture model. The longitudinal analyses addressed two potential data biases. RESULTS: Questionnaire submission rates were 91% at baseline, 68% at 13 weeks, and 47% at 25 weeks. The cross-sectional and mixed linear model analyses did not show significant differences by treatment arm in patient-reported QOL. The pattern mixture model analysis, more appropriate given non-ignorable missing data, also found no statistically significant effect of treatment on patient QOL. CONCLUSION: We present a sensitivity analysis approach with multiple methods for analyzing treatment effects on patient QOL in the presence of substantial, non-ignorable missing data in an advanced stage disease clinical trial. We conclude that the two treatment arms did not differ statistically in their effects on patient QOL over a 25-week treatment period.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1998

Influence of fracture criteria on the outcome of a randomized trial of therapy.

Based on a presumption that the morphometric approach to vertebral fracture assessment is beset by false positive deformities, it has been suggested that more stringent criteria should be used to asses vertebral fracture outcomes in clinical trials of osteoporosis therapies. We applied a variety of criteria in the reanalysis of a randomized trial of sodium fluoride therapy for women with established osteoporosis. Although progressively more severe criteria reduced the cumulative incidence of a new vertebral fracture in both those receiving a placebo and the fluoride-treated patients, differences between the two groups were not magnified and none of the suggested approaches produced a statistically significant result. These findings indicate that the false positive rate associated with morphometric assessment of vertebral fractures is not so great as supposed from theoretical considerations that assume independence among the measurements. Our findings also provide some reassurance that differences in the criteria used to define a vertebral fracture are not the controlling influence in the likelihood that a particular clinical trial will find a result favoring one treatment over another.

Aged↗

PubMed1998

Offering a randomized trial of intensive therapy for IDDM to adolescents. Reasons for refusal, patient characteristics, and recruiter effects.

OBJECTIVE: To identify reasons adolescents refuse to participate in a randomized trial of intensive therapy (IT) for IDDM, to describe the patient characteristics of those who consent and those who refuse to participate, and to examine recruiter effects on trial participation rates. RESEARCH DESIGN AND METHODS: A total of 99 adolescents, age 11-18 years, were provided with the results of the Diabetes Control and Complications Trial and approached for possible study participation by two nurse recruiters. Adolescents refusing the trial were administered a semi-structured interview to describe reasons for study refusal; responses were recorded and later coded into categories. Patient characteristics of consenters and refusers were collected and compared. The differential enrollment rates of the two nurse recruiters were also compared. RESULTS: A total of 56 patients (approximately 57%) agreed to participate; 43 refused. The four most common reasons for study refusal were 1) increased clinic visits (42%), 2) increased insulin injections (30%), 3) increased frequency of self-monitoring of blood glucose (SMBG) (28%), and 4) transportation difficulties (19%). Concerns about randomization to an unwanted treatment condition and fears of hypoglycemia or weight gain were rarely cited. Consenters and refusers did not differ in demographic characteristics, disease status, or family composition. Large differences were found between the two nurse recruiters: one experienced a 60% refusal rate, while the other experienced a 27% refusal rate. CONCLUSIONS: Issues of convenience (increased clinic visits, transportation difficulties) and concerns about the demands of IT (increased injections and SMBG) were the predominant reasons for trial refusal. Patient characteristics did not differentiate consenters from refusers. However, recruiters differed greatly in study refusal rates, suggesting that provider behavior may be an important but understudied aspect of adolescent acceptance of randomized trials in general and IT in particular.

Adolescent↗

PubMed1991

[Randomized trial of combined chemotherapy including high dose cisplatin and radiotherapy for esophageal cancer].

A prospective randomized trial in 64 esophageal cancer patients was conducted from 1986 to 1989. The patients were randomized into two groups-PPF (DDP 100 mg/m2 + pingyangmycin + 5-FU) regimen plus radiotherapy (combined group) or radiotherapy alone (control group). The overall response rate and CR rate in the combined group were 87.5% (28/32) and 40.6% (13/32). Those of the control group were 81.3% (26/32) and 21.9% (7/32), respectively. The overall response rates were similar in these two groups, but the CR rate in the combined groups was higher than that of the control group. The 1-year survival rates in the combined and control groups were 77.4% (24/31) and 45.2% (14/31) (p less than 0.01). The 2-year survival rates were 56.3% (9/16) and 34.6% (9/26), respectively (p greater than 0.05). Our preliminary results show that combined chemotherapy including high dose cisplatin and radiotherapy may improve the therapeutic result of esophageal cancer.

Adult↗

PubMed1992

Fertility outcome after conservative surgical treatment of ectopic pregnancy evaluated in a randomized trial.

OBJECTIVE: To evaluate the fertility outcome after laparoscopic surgery for ectopic pregnancy. DESIGN: A randomized trial versus laparotomy was performed between May 1987 and June 1989. SETTING: The study was conducted in a clinical university center, the Sahlgrens Hospital. PATIENTS: A group of 105 patients with tubal pregnancy were stratified with regard to risk determinants and age and randomized to laparoscopy or laparotomy. Eighty-seven patients who desired pregnancy were evaluated for subsequent fertility outcome. INTERVENTIONS: Linear salpingotomy was performed in both surgical groups. MAIN OUTCOME MEASURE: We evaluated the fertility outcome after laparoscopic salpingotomy for comparison with the outcome after laparotomy. RESULTS: There was no difference between the groups in the overall fertility outcome. A substantially higher proportion of patients in the laparotomy group were subjected to adhesiolysis performed at a second-look laparoscopy. CONCLUSIONS: The fertility prospects are not impaired by laparoscopic surgery. Adhesiolysis at a second-look laparoscopy, especially after laparotomy, might be beneficial in selected cases and may serve to improve subsequent fertility.

Female↗

PubMed2005

A randomized trial of steroid avoidance in renal transplant patients treated with everolimus and cyclosporine.

In this randomized trial renal transplant recipients were treated with basiliximab, everolimus 3 mg/day, low-dose CsA. At transplantation, patients were randomized to stop steroids at the seventh day (group A) or to continue oral steroids in low doses (group B). Of the 113 patients enrolled, 65 were randomized to group A and 68 to group B. All patients were followed for 2 years. During the study 28 (43%) group A patients required reintroduced corticosteroids. One patient died, in group B. The Graft survival rate was 97% in group A and 90% in group B. There were more biopsy-proven rejections in group A (32% vs 16%; P = .044). The mean creatinine clearance was 54 +/- 21 mL/min in group A vs 56 +/- 22 mL/min in group B. Mean levels of serum cholesterol tended to be lower in group A, but the difference was of borderline significance (191 +/- 91 vs 251 +/- 188 mg/dL; P = .07). Vascular thrombosis (0 vs 5) and pneumonia requiring hospitalization (2 vs 7) tended to be more frequent in group B. Only three cases of CMV infection (1 vs 2) occurred. An immunosuppressive therapy with everolimus and low-dose CsA allows one to obtain excellent renal graft survival and stable graft function at 2 years. Early interruption of steroids in patients treated with this regimen may increase the risk of acute rejection, but neither affects graft survival nor graft function, while possibly reducing the risk of hyperlipemia and vascular thrombosis. About 60% of patients given everolimus and low-dose CsA can definitively stop steroids after 1 week.

Adolescent↗

PubMed1988

Follow-up of prospective randomized trial of ampicillin or chloramphenicol versus moxalactam treatment of Haemophilus influenzae type b meningitis.

In a prospective randomized trial, moxalactam administered to 66 children was compared with ampicillin or chloramphenicol given to 68 children for the treatment of Haemophilus influenzae type b meningitis. Acute morbidity and mortality rates were equivalent between the two treatment groups. At 2 years after discharge, the results of psychologic tests (Bayley Scales of Infant Development or McCarthy Scales of Children's Abilities) were also equivalent between the two treatment groups for patients remaining in the study.

Ampicillin↗

PubMedDate not supplied

The randomized clinical trial.

Randomized clinical trials were developed to eliminate biases inherent in clinical medicine. Six types of bias that can occur during patient selection and treatment allocation and in the collection and analysis of the data have been identified. A variation of the prospective randomized clinical trial, the nonrandomized surgeon design, overcomes biases specific to surgical investigations.

Animals↗

PubMed2005

[Randomized trial of breast self-examination in 266,064 women in Shanghai].

OBJECTIVE: A randomized trial of breast self-examination (BSE) program was carried out to evaluate whether the intensive BSE can reduce the death number of women from breast cancer. METHODS: A total of 266,064 women (age of 30 to 64 years) associated with 519 textile factories in Shanghai had been randomly assigned to a BSE instruction group (132,979 women) or a control group (133,085 women) since 1989. Initial instruction in BSE group included demonstration of proper palpation techniques. It was followed by 2 reinforcement sessions during the subsequent 4 years including video shows, BSE instruction sessions and BSE practice under medical supervision. These activities were continued for 5 years. Attendance at all events was recorded. The cohort was followed through July 2000 for development of breast diseases, and the breast cancer cases were followed up through 2001 for vital status. The data analysis methods used included Kaplan-Meier plots, Log-rank test and Cox modeling. RESULTS: Among women under instruction, 864 breast cancers were detected and 133 breast cancer deaths occurred, and 896 breast cancers were detected and 130 deaths recorded in the control group. The tumor size (P = 0.07), TNM stage (P = 0.39) and cumulative breast cancer mortality rate (P = 0.72) were not significantly different between the 2 groups. However, more and smaller fibroadenomas were detected in the instruction group than in the control group (P < 0.01). CONCLUSION: Intensive instruction in BSE can not reduce mortality rate of breast cancer, but more and smaller benign breast lumps can be detected.

Adult↗

PubMed1993

[A randomized trial of intrahepatic infusion chemotherapy for unresectable colorectal liver metastases. Sendai Study Group].

A prospective, controlled randomized trial of hepatic arterial infusion of 5-fluorouracil (5-FU), adriamycin (ADM) and mitomycin C (MMC) [FAM group] versus 5-FU, epirubicin (EPIR) and MMC [FEM group] in patients with unresectable liver metastasis from colorectal cancer is reported. No objective response was observed in FAM group (n = 6), while two objective responses, 1 complete and 1 partial (22.2%), were achieved in FEM group (n = 9). There was no significant difference in the 50% survival period between the two groups (468 days in FAM group (n = 8) versus 462 days in FEM group (n = 10). Long survival over 2 years was observed in FEM group, but not in FAM group. Toxicities were recorded in 50% (3/6) of FAM group, and 80% (8/10) of FEM group, but they were mild and well tolerated. In conclusion, although there was no significant difference in clinical effects between the two groups, the use of EPIR instead of ADR in combination with 5-FU and MMC might be favorable for intrahepatic infusion chemotherapy because responders and long-term survival were exclusively observed in FEM group.

Adult↗

PubMed2003

A randomized trial comparing induction chemotherapy followed by surgery with surgery alone for patients with stage IIIA N2 non-small cell lung cancer (JCOG 9209).

OBJECTIVE: We performed a prospective randomized trial in patients with potentially resectable stage IIIA N2 non-small cell lung cancer to confirm the efficacy of induction chemotherapy before surgical resection. METHODS: Patients with stage IIIA N2 non-small cell lung cancer, all with histologically or cytologically confirmed metastases to the ipsilateral mediastinal lymph nodes, were randomly assigned to receive either three cycles of induction chemotherapy (cisplatin at 80 mg/m(2) on 1 day and vindesine at 3 mg/m(2) on 2 days) followed by surgery or surgery alone. RESULTS: This trial was prematurely terminated because the accrual rate was too slow, which lowered the study's statistical power considerably. From June 1993 through April 1998, a total of 62 patients were enrolled, and 31 patients were assigned to each treatment group. The objective clinical response rate of induction chemotherapy was 28%. Complete resection was achieved in 20 patients in the induction chemotherapy group (65%) and 24 in the surgery alone group (77%). Median follow-up was 6.2 years. Median overall survivals were 17 months for the induction group and 16 months for the surgery alone group. The estimated 1-, 3-, and 5-year survivals, respectively, were 68% (95% confidence interval 51%-85%), 23% (95% confidence interval 8%-38%), and 10% (95% confidence interval 0%-20%) for the induction chemotherapy group and 65% (95% confidence interval 48%-82%), 26% (95% confidence interval 11%-41%), and 22% (95% confidence interval 7%-37%) for the surgery alone group. There was no statistically significant difference in survival between the groups (P =.5274). Treatment-related death was not observed in either group. CONCLUSION: This randomized trial to compare induction chemotherapy (cisplatin and vindesine) followed by surgery with surgery alone for patients with stage IIIA N2 non-small cell lung cancer did not demonstrate a survival difference between the groups, although this may have been because the statistical power was limited.

Adult↗