SEARCH · PubMed Health

Results for “Random Allocation”

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 1,387 records · Page 77Linked to original sources

PubMed1988

Treatment of urinary tract infections in Hong Kong: a comparative study of norfloxacin and co-trimoxazole.

The study compared the efficacy and safety of norfloxacin to those of co-trimoxazole in the treatment of urinary tract infections (UTI). A total of 172 adults, 42 men and 130 women were recruited and randomly allocated to norfloxacin or co-trimoxazole using a double-blind study design. Patients with lower UTI received norfloxacin 200 mg or co-trimoxazole (160 mg of trimethoprim plus 800 mg of sulphamethoxazole) b.i.d. for seven days. In patients with upper UTI, the norfloxacin dose was 400 mg b.i.d. for seven days. Eleven to 14 days after treatment, the bacteriological cure rates were 96.8% and 83.3% and the clinical cure rates were 96.9% and 89.9% for norfloxacin and co-trimoxazole, respectively. A few patients complained of gastrointestinal symptoms but there were few other side-effects and the treatments were well tolerated. In conclusion, both norfloxacin and co-trimoxazole were well tolerated but norfloxacin gave higher cure rates.

Adult↗

PubMed1984

The effectiveness of attached social workers in the management of depressed female patients in general practice.

There is a pressing need to evaluate the different forms of treatment for depressive illness encountered in general practice. This study consists of a controlled, randomized, clinical trial designed to investigate the effectiveness of social work intervention with depressed women. Eighty women aged between 18 and 45 were included and assessed initially by means of a psychiatric and social interview. Those ascertained to be suffering from 'acute' or 'acute on chronic' depression were randomly allocated to an experimental group who were referred to a social worker attached to a general practice or to a control group for routine treatment by their doctor. They were re-assessed 6 months later. Over 60% of both groups were clinically improved at follow-up, with no statistically significant differences between the two groups in clinical, social or medical outcome. Further analyses suggested, however, that those women initially assessed as suffering from 'acute on chronic' depression with major marital difficulties were found to benefit from social work treatment. These patients could be distinguished from the others by their high degree of motivation, by the initial severity of their problems and by the amount of practical help provided by the social workers.

Adjustment Disorders↗

PubMed1988

Trial of tissue plasminogen activator for mortality reduction in acute myocardial infarction. Anglo-Scandinavian Study of Early Thrombolysis (ASSET).

13,318 patients admitted to fifty-two coronary care units with suspected acute myocardial infarction were considered for inclusion in a double-blind study comparing recombinant tissue-type plasminogen activator (rt-PA) 100 mg plus heparin with placebo plus heparin. 8307 (62%) were excluded, mainly because their symptoms had begun more than 5 h previously, but all excluded patients were followed up at least until hospital discharge. 2516 patients were randomly allocated to rt-PA and 2495 to placebo. At one month the overall case fatality rates were 7.2% and 9.8%, respectively, a relative reduction of 26% (95% confidence interval 11-39%). 6.3% of patients given rt-PA had a bleeding complication (1.4% major) compared with 0.8% given placebo (0.4% major). However, the incidence of stroke was similar--1.1% in the rt-PA group and 1.0% in the placebo group. Subset analysis showed that patients who had a normal electrocardiogram (ECG) at the time of randomisation (17.5% of the whole trial population) had a low case fatality rate (1.6% in those given rt-PA compared with 3.0% in those given placebo). In those with an abnormal ECG at entry, rt-PA was associated with a 24.5% relative reduction in 1 month fatality (95% confidence interval 9-37%).

Adolescent↗

PubMed1985

Precurarization with vecuronium and pancuronium in awake, healthy volunteers: the influence on neuromuscular transmission and pulmonary function.

The influence of pretreatment with pancuronium and vecuronium on the neuromuscular transmission was compared in 24 healthy, awake, non-premedicated volunteers using train-of-four (TOF) nerve stimulation and measurement of respiratory frequency, vital capacity, inspiratory force and peak expiratory flow (PEF). The subjects were randomly allocated to one of three groups. Each subject received one dose of pancuronium and one dose of vecuronium: Group I pancuronium 0.01 mg/kg and vecuronium 0.005 mg/kg; Group II pancuronium 0.01 mg/kg and vecuronium 0.01 mg/kg and Group III pancuronium 0.01 mg/kg and vecuronium 0.015 mg/kg intravenously. The median TOF ratio decreased significantly in Groups I and II following both pancuronium and vecuronium. The TOF ratio following vecuronium in Group II was significantly lower compared to the TOF ratio following vecuronium in Group I. Only PEF decreased significantly in Group I following pancuronium and in Group II following both pancuronium and vecuronium. There was no significant difference between Group I and Group II regarding the number of subjects with signs or symptoms of partial neuromuscular blockade. Following vecuronium 0.005 mg/kg, one subject was unable to swallow and the twitch height decreased to 0.25. In Group II one subject was unable to lift her head and had difficulty in swallowing following pancuronium 0.01 mg/kg. Only four subjects entered Group III because of an unacceptably high frequency of signs and symptoms of partial neuromuscular blockade and a decrease in median TOF ratio to 0.64 following vecuronium. The subjects felt it difficult to swallow, and one subject could just sustain head lift for 10 s following vecuronium 0.015 mg/kg.(ABSTRACT TRUNCATED AT 250 WORDS)

Consciousness↗

PubMed2000

An effectiveness trial of a diagnostic test in a busy outpatients department in a developing country: issues around allocation concealment and envelope randomization.

Methods to ensure allocation concealment in a randomized controlled trial in a busy outpatients department may disrupt usual clinical behavior, and thereby modify the effect of a diagnostic test. In a clinical trial of chest radiography in ambulatory children, concealment was maintained by means of sealed sequentially numbered manila envelopes. Baseline information was collected on all potential participants before they were presented to a clinician for a decision on inclusion in the trial. Excluded patients were followed up. Of 59 excluded patients, only 16 allocation envelopes had been opened or were not accounted for, although 12 of these had non-radiograph allocations (P = 0.05). There was no difference between patients excluded from radiograph and non-radiograph groups in baseline characteristics or primary outcome measure. Most of the improper exclusions occurred early in the study; improved monitoring and feedback reduced the problem. Sealed opaque sequentially numbered envelopes may be appropriate for trials of diagnostic tests in settings where centralized randomization is not feasible, and given careful monitoring of the enrollment process.

Child↗

PubMed1988

[Vecuronium bromide: modification of its pharmacodynamics by etomidate, cimetidine and ranitidine].

After obtaining their informed consent, 60 patients (ASA groups I or II), 18 to 60 years of age were randomly allocated to six groups of 10 persons each. Anesthesia was induced in groups 1, 4, 5 and 6 with 2-3 mg kg-1 thiopentone and in groups 2 and 3 with 0.2-0.3 mg kg-1 etomidate. 20 min before induction, patients in groups 3 and 5 received 5 mg kg-1 cimetidine, and patients in group 6 received 1.25 mg kg-1 ranitidine. Induction of anesthesia was supplemented by 0.002 mg kg-1 fentanyl and 0.01 mg kg-1 lormetazepam. After beginning neuromuscular monitoring, 0.08 mg kg-1 vecuronium was injected and the intubation accomplished when the first twitch of the train of four (TOF) was suppressed of a rate greater than 90%. The anesthesia was maintained with supplemental doses of 0.002 mg kg-1 fentanyl and 0.01 mg kg-1 lormetazepam, if necessary, and the use of a nitrous oxide/oxygen mixture (2.4:1.6 l min-1). A train of four supramaximal nerve stimuli was applied to the ulnar nerve proximal to the wrist and the twitch responses were electrically recorded on the hypothenar musculature (Relaxograph, Datex). The frequency of the train was 2 Hz with an interval of 20 s between trains. The time from the injection of vecuronium to several degrees of neuromuscular recovery was statistically significantly prolonged after 5 mg kg-1 cimetidine (groups 3 and 5) in comparison to the other groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed1999

Children's attitudes toward interacting with peers with different craniofacial anomalies.

OBJECTIVE: This study was designed to evaluate children's understanding of different craniofacial anomalies and their willingness to interact with children with such anomalies. DESIGN: This was a between-measures design in which children were randomly allocated to one of three groups. Each group viewed one of three pairs of computer-generated images (nondistinctive, cleft lip, or misshapen nose) of similar-aged children. SETTING: Participants were recruited from two city elementary schools and were interviewed at their schools. PARTICIPANTS: A total of 100 children (aged 7 to 10 years) entered the study, and complete sets of data were obtained for each child. As the majority of the children were white (n = 92), the nonwhite children (n = 8) were excluded from the data analyses. MAIN OUTCOME MEASURES: Participants were asked a number of questions to ascertain their thoughts about the image, and measures were then taken of each child's willingness to interact with the stimulus child. RESULTS: There were no significant differences between the three groups. Boys were significantly more willing to interact with the stimulus images than were girls, and there was a nonsignificant trend for girls to be more likely to spontaneously mention the craniofacial anomaly. Participants gave varied explanations for the condition's causation. CONCLUSIONS: Boys and girls differed in their willingness to interact with unfamiliar peers with and without facial distinctions. Various explanations were given to explain causality of the anomaly. Findings lend some support to the proposal that high "background attractiveness" can overshadow the impact of a craniofacial anomaly.

Analysis of Variance↗

PubMed1983

Co-trimoxazole and trimethoprim in complicated urinary tract infection.

Previous work has suggested that co-trimoxazole may be superior to trimethoprim in the treatment of complicated urinary tract infection. A prospective study has been done to assess the relative value of the drugs in this situation using trimethoprim at higher than normal dosage. Fifty three patients (33 women and 20 men) were randomly allocated to either a fourteen-day course of co-trimoxazole tabs, 2 twice a day (27 patients) or trimethoprim 250 mg twice a day (26 patients). After patient withdrawals from the study, 17 (77%) of the co-trimoxazole group achieved a sterile urine three weeks after starting treatment compared with 15 (65%) in the trimethoprim group (X2 = 0.80). When those patients with sterile urine at three weeks who could be reassessed four weeks later were analyzed, 8 (89%) of the co-trimoxazole patients maintained a sterile urine against 7 (58%) in the trimethoprim group (X2 = 1.09). Although statistical significance was not attained, the results suggest that even at increased dosage, trimethoprim would not appear to be as efficient as co-trimoxazole in complicated urinary tract infection.

Adult↗

PubMed1990

Chemotherapy-based control of schistosomiasis haematobia. II. Metrifonate vs. praziquantel in control of infection-associated morbidity.

To determine the relative efficacy of metrifonate and praziquantel in controlling urinary tract morbidity due to Schistosoma haematobium infection, a random allocation treatment trial was performed among 1,813 school age S. haematobium-infected children from the Msambweni area of Coast Province, Kenya. Following baseline examination for infection, hematuria, proteinuria, and ultrasonographic urinary tract abnormalities, oral treatment with either metrifonate (10 mg/kg, repeated at 4 month intervals) or praziquantel (1 dose of 40 mg/kg) was given to infected subjects. Prevalence of morbidity was reassessed 12 months later for each treatment group. Results indicated equivalent patient improvement in response to either regimen: prevalence of hematuria fell from 75% to 17% after either praziquantel or metrifonate therapy. Similarly, prevalence of proteinuria was significantly reduced from 73% to 29% (metrifonate) or 27% (praziquantel) after therapy. Metrifonate and praziquantel caused similar reductions in bladder granulomata and bladder thickening; however, no reduction in hydronephrosis was noted with either drug. Analysis of outcomes in population subgroups defined by age, sex, pretreatment intensity of infection, or severity of pretreatment morbidity showed no consistent advantage for either drug. In this endemic area, both agents provide effective control of morbidity due to urinary schistosomiasis.

Adolescent↗

PubMed2002

Treatment of acute lymphoblastic leukemia in the elderly: an evaluation of interferon alpha given as a single agent after complete remission.

Although interferon (IFN) has been used in elderly patients with acute lymphoblastic leukemia (ALL), the benefits from IFN therapy have not been properly assessed, especially as it was given combined with other cytotoxic drugs, which obscured the role of IFN if any. In 1997, we started a study aimed at improving our previous results in elderly patients with ALL and at assessing the therapeutic role of IFN in this disease. Fifty-eight patients with ALL, aged 55-81 years (median: 64.9 years), were randomly allocated to treatment with vindesine or vincristine during induction. After a first consolidation course, IFN was administered as a single agent for three months together with cranial radiotherapy. Chemotherapy was then resumed with a second consolidation course and maintenance. A complete remission (CR) was obtained in 58% of patients (CI: 45-71%), significantly less than in our previous study which included IFN combined with chemotherapy during maintenance (CR: 85%, CI:70-94%, p = 0.007). Overall survival (median: 289 vs 434 days in the previous study, p = 0.01) and disease-free survival (median: 146 vs 427 days, p = 0.009) were also inferior in the present study. In particular, the pattern of relapses over time suggested that the 3 month IFN treatment phase with no additional chemotherapy might have contributed to the comparatively poor outcome of this cohort. In addition, vindesine given during induction did not prove less neurotoxic than vincristine, did not improve the CR rate, and had no impact on survival. In conclusion, although similar to published studies in elderly patients with ALL, this study is inferior to our previous one. INF, given as a single drug, has a modest role if any in the treatment of older persons with ALL.

Aged↗

PubMed1996

Efficacy and safety of rifabutin in the treatment of patients with newly diagnosed pulmonary tuberculosis.

The efficacy and safety of rifabutin (RBT) and rifampicin (RMP) were compared in 298 patients with newly diagnosed pulmonary tuberculosis. In the initial 8-wk phase, all patients received isoniazid 400 mg/d, ethambutol 1200 mg/d, and pyrazinamide 2 g/d and were randomly allocated to receive either RMP 600 mg/d or RBT 300 mg/d. In the 16-wk continuation phase, patients received intermittent treatment (twice weekly) with isoniazid 600 mg/d, ethambutol 2400 mg/d and either RMP 600 mg/d or RBT 300 mg/d. Two hundred twenty-five (RMP = 118; RBT = 107) patients completed the 24-wk treatment period (evaluable patient population). Bacteriologic conversion rates in the RMP and RBT groups were 87.7 versus 92.0% at Week 8, 99.1 versus 99.0% at Week 12, 93.5 versus 93.8% at Week 24, and 89.8 versus 95.3% at the last valid observation. The mean time to first bacteriologic conversion was 14.1 wk in the RMP group and 14.3 wk in the RBT group. None of these differences was significant. Adverse events were reported by four patients (five events) in the RMP group and six patients (six events) in the RBT group. Those events thought to be associated with RMP were increased SGOT and leucopenia and, with RBT, increased SGOT and thrombocytopenia. Two hundred four patients entered the follow-up phase, and, of these, 95 (RMP = 49; RBT = 46) completed the scheduled 24-mo period. The overall rate of relapse was 3.8% (4/106) for the RMP group and 5.1% (5/98) for the RBT group. These differences were not significant. All relapsed patients, except for two who could not be traced, were successfully retreated. We conclude that the efficacy and tolerability of RBT is equivalent to that of RMP in the treatment of newly diagnosed uncomplicated tuberculosis, and that RBT can be effectively administered in a part-daily, part-intermittent dosage schedule.

Adolescent↗

PubMed1988

Efficacy of sequential cyclical hormonal therapy in endometrial cancer and its correlation with steroid hormone receptor status.

Forty-six eligible women with metastatic endometrial cancer were randomly allocated to receive monthly cycles of either CAF (cyclophosphamide, adriamycin, 5-fluorouracil) or CAF plus Provera 200 mg daily for 3 weeks followed cyclically by Tamoxifen 20 mg daily for 3 weeks. Overall response rates of 15 and 43% were seen with CAF and CAF plus hormonal therapy. Using a multivariate analysis of the results, this difference is significant (P value 0.05). In 8 patients with operable endometrial cancer, negative estrogen receptor concentration (ER less than 15 fmole/mg protein) and Grade 3 disease, the clinical course was aggressive in 4 patients with systemic and local relapse. In 10 other similar patients (negative ER and Grade 3) who received adjuvant cyclical hormonal therapy only 1 relapsed and the other 9 are disease-free for an average of more than 31 months. Sequential cyclical hormonal therapy with ER and progesterone receptor analysis has a place in the management of endometrial carcinoma.

Adenocarcinoma↗

PubMed1993

Who's afraid of informed consent?

OBJECTIVE: To test the assumption that patients will become unduly anxious if they are given detailed information about the risks of surgery in an attempt to obtain fully informed consent. DESIGN: Preoperative anxiety assessed before and after patients were randomly allocated an information sheet containing either simple or detailed descriptions of possible postoperative complications. SETTING: Four surgical wards at two Sheffield hospitals. SUBJECTS: 96 men undergoing elective inguinal hernia repair under general anaesthesia. MAIN OUTCOME MEASURE: Change in anxiety level observed after receiving information about potential complications. RESULTS: Detailed information did not increase patient anxiety (mean Spielberger score at baseline 33.7 (95% confidence interval 31.3 to 36.2), after information 34.8 (32.1 to 37.5); p = 0.20, paired t test). A simple explanation of the facts provided a statistically significant degree of reassurance (mean score at baseline 34.6 (31.5 to 37.6), after information 32.3 (29.8 to 34.9); p = 0.012), although this small effect is likely to be clinically important only in those whose baseline anxiety was high (r = 0.27, p = 0.05). CONCLUSIONS: In men undergoing elective inguinal hernia repair a very detailed account of what might go wrong does not increase patient anxiety significantly and has the advantage of allowing patients a fully informed choice before they consent to surgery, thus reducing the potential for subsequent litigation.

Anxiety↗

PubMed1989

Routine formal fetal movement counting and risk of antepartum late death in normally formed singletons.

The routine recommendation to women to count fetal movements daily during late pregnancy for the prevention of antepartum late fetal death in normally formed singletons has been evaluated. 68,000 women were randomly allocated within thirty-three pairs of clusters either to a policy of routine counting or to standard care, which might involve selective use of formal counting or informal noting of movements. Antepartum death rates for normally formed singletons were similar in the two groups, regardless of cause of prior risk status. Despite the counting policy, most of these fetuses were dead by the time the mothers received medical attention. The study does not rule out a beneficial effect, but at best, the policy would have to be used by about 1250 women to prevent 1 unexplained antepartum late fetal death, and an adverse effect is just as likely. In addition, formal routine counting would use considerable extra resources.

Belgium↗

PubMed1982

The Veterans Administration Cooperative Study of stable angina: current status.

The current status of the Veterans Administration Cooperative Study of the effect of surgery on survival in patients with stable angina is presented. The outcome in 686 adult males randomly allocated to medical or surgical treatment groups in 1972-1974 was studied in subgroups of patients classified by invasive (arteriographic) and noninvasive risk factors. In 91 patients with left main lesions reducing the luminal diameter 50% or more, surgery significantly improved survival in the two-thirds characterized as middle or high risk by four simple noninvasive predictors of prognosis (New York Heart Association functional classification III or IV, history of myocardial infarction, history of hypertension, and ST-segment depression on the resting baseline ECG as assessed on a centralized reading). Patients with three-vessel disease and no significant disease of the left main coronary artery also had better survival rates when treated surgically. However, this was statistically significant at 6 years only in the 10 hospitals in which the aggregate operative mortality was 3.3%. Patients without left main lesions were also categorized by four noninvasive predictors of risk. Categorizing such patients into roughly equal groups of high, middle, and low risk identified a high-risk group, in which surgery was associated with statistically improved survival, and low- and middle-risk groups in which it was not. The use of both invasive and noninvasive factors to assess risk in patients with chronic stable angina pectoris provided greater predictive power than either angiography or noninvasive factors alone.

Angina Pectoris↗

PubMed1984

Lack of effect of bretylium tosylate on electrical ventricular defibrillation in a controlled study.

The threshold stored energy and transthoracic current for electrical defibrillation were determined in dogs anaesthetised with pentobarbitone. Groups were randomly allocated to pre-treatment with either saline or bretylium. The intravenous administration of bretylium tosylate (10 to 30 mg . kg-1) did not significantly alter either measurement. The drug caused large changes in heart rate and arterial blood pressure.

Animals↗

PubMed1981

Monthly plasmapheresis for systemic lupus erythematosus with diffuse proliferative glomerulonephritis: a pilot study.

Twelve patients with systemic lupus erythematosus and biopsy-proved diffuse proliferative glomerulonephritis were randomly allocated to a control group (to continue receiving conventional therapy only) or to a plasmapheresis group (to receive conventional therapy along with one 4-I plasma exchange a month). The six patients treated with plasmapheresis had better preservation of renal function, reduced disease activity, fewer admissions to hospital and less need for steroid and immunosuppressive therapy than the six control patients. The patients treated with plasmapheresis also showed evidence of reduced immunologic activity and had no side effects attributable to the plasma exchange. These results suggest that monthly plasma exchange should be assessed in a controlled randomized trial as a possible therapeutic adjunct in patients with systemic lupus erythematosus and diffuse proliferative glomerulonephritis.

Creatinine↗

PubMed1984

Whole gut lavage for colonoscopy--a comparison between two solutions.

The clinical efficacy and patient acceptability of a new solution containing mainly sodium sulfate and polyethylene glycol (solution II) compared with a balanced standard electrolyte solution (solution I) for whole gut lavage prior to colonoscopy were evaluated in 240 ambulatory and hospital patients randomly allocated to receive either of the two solutions. On the basis of the quality and rapidity of the bowel preparation and the good results obtained by clinical and biological parameters, we found that the newly designed solution was superior.

Colonoscopy↗