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 1,351 records · Page 75Linked to original sources

PubMed1985

MRC trial of treatment of mild hypertension: principal results. Medical Research Council Working Party.

The main aim of the trial was to determine whether drug treatment of mild hypertension (phase V diastolic pressure 90-109 mm Hg) reduced the rates of stroke, of death due to hypertension, and of coronary events in men and women aged 35-64 years. Subsidiary aims were: to compare the course of blood pressure in two groups, one taking bendrofluazide and one taking propranolol, and to compare the incidence of suspected adverse reactions to these two drugs. The study was single blind and based almost entirely in general practices; 17 354 patients were recruited, and 85 572 patient years of observation have accrued. Patients were randomly allocated at entry to take bendrofluazide or propranolol or placebo tablets. The primary results were as follows. The stroke rate was reduced on active treatment: 60 strokes occurred in the treated group and 109 in the placebo group, giving rates of 1.4 and 2.6 per 1000 patient years of observation respectively (p less than 0.01 on sequential analysis). Treatment made no difference, however, to the overall rates of coronary events: 222 events occurred on active treatment and 234 in the placebo group (5.2 and 5.5 per 1000 patient years respectively). The incidence of all cardiovascular events was reduced on active treatment: 286 events occurred in the treated group and 352 in the placebo group, giving rates of 6.7 and 8.2 per 1000 patient years respectively (p less than 0.05 on sequential analysis). For mortality from all causes treatment made no difference to the rates. There were 248 deaths in the treated group and 253 in the placebo group (rates 5.8 and 5.9 per 1000 patient years respectively). Several post hoc analyses of subgroup results were also performed but they require very cautious interpretation. The all cause mortality was reduced in men on active treatment (157 deaths versus 181 in the placebo group; 7.1 and 8.2 per 1000 patient years respectively) but increased in women on active treatment (91 deaths versus 72; 4.4 and 3.5 per 1000 patient years respectively). The difference between the sexes in their response to treatment was significant (p = 0.05). Comparison of the two active drugs showed that the reduction in stroke rate on bendrofluazide was greater than that on propranolol (p = 0.002). The stroke rate was reduced in both smokers and non-smokers taking bendrofluazide but only in non-smokers taking propranolol. This difference between the responses to the two drugs was significant (p = 0.03).(ABSTRACT TRUNCATED AT 400 WORDS)

Adult↗

PubMed1983

Randomized comparative study of efficacy of furosemide versus spironolactone in nonazotemic cirrhosis with ascites. Relationship between the diuretic response and the activity of the renin-aldosterone system.

Loop and distal diuretics are the basic drugs for the treatment of ascites. Although pharmacologic studies indicate that the natriuretic potency of loop diuretics is much greater than that of distal diuretics, there are no studies comparing the efficacy of these drugs in cirrhosis. Forty nonazotemic cirrhotic patients with ascites and avid sodium retention were randomly allocated into two groups. Group 1 contained 21 patients treated with furosemide; group 2 contained 19 patients treated with spironolactone. The initial doses were 80 and 150 mg/day, respectively. These doses were increased to 160 and 300 mg/day, respectively, if there was no response. Cases not responding to furosemide and spironolactone were later treated with spironolactone and furosemide, respectively. In group 1, 11 of the 21 patients responded to furosemide, while in group 2, 18 of the 19 patients responded to spironolactone (p less than 0.01). Of the 10 patients in group 1 not responding to furosemide, 9 responded later to spironolactone. The diuretic response to furosemide and spironolactone was related to the activity of the renin-aldosterone system. Patients with higher renin and aldosterone did not respond to furosemide and required 300 mg/day of spironolactone to achieve a diuretic response. These results indicate that (a) at the dosages used in the study, spironolactone is more effective than furosemide in nonazotemic cirrhosis with ascites, and (b) the activity of the renin-aldosterone system influences the diuretic response to furosemide and spironolactone in these patients.

Ascites↗

PubMed1990

A randomized study of two vindesine plus cisplatin-containing regimens with the addition of mitomycin C or ifosfamide in patients with advanced non-small cell lung cancer.

The current trial was carried out to assess the survival enhancement achieved, if any, by adding ifosfamide to vindesine and cisplatin (IVP) in contrast to mitomycin plus vindesine and cisplatin (MVP). Between June 1986 and September 1988, 110 patients were randomly allocated to receive either ifosfamide (3 g/m2 plus 3 g/m2 of mesna) or mitomycin 8 mg/m2, on days 1, 29, and 71 only. In both arms vindesine was given 3 mg/m2 weekly X 5 then every 2 weeks. In the MVP arm, 120 mg/m2 of cisplatin was administered on days 1 and 29 and then every 6 weeks, whereas in the IVP arm 100 mg/m2 of cisplatin was given on the same time schedule. One hundred three patients were evaluable for response and toxicity and 56% of patients had Mountain's Stage IV disease. The response rate was 26% (14/53 patients) in the MVP arm (95% confidence interval, 14%-39%) and 20% (ten of 50 patients) in the IVP arm (95% confidence interval, 10%-34%). Neither the response rate nor the median survival times were significantly different, although more nephrotoxicity was produced in the MVP arm, grade 1+ in 43% versus 26% in IVP arm (P = 0.04). Results obtained from this study fail to demonstrate that mitomycin or ifosfamide have a synergistic effect on the efficacy of the vindesine/cisplatin combination.

Adult↗

PubMed1985

Perusing the literature: comparison of MEDLINE searching with a perinatal trials database.

The existence of a Register of Controlled Trials in Perinatal Medicine (National Perinatal Epidemiology Unit, Oxford, England) has offered an opportunity to assess the efficacy of online searching of MEDLINE, an example of a broad bibliographic database. Retrieval of all relevant randomized control trials (RCTs) in a given field is important in analyses in which results are pooled (meta-analyses). Reports of RCTs of prevention and treatment of neonatal hyperbilirubinemia and prevention of intraventricular hemorrhage (IVH) for the years 1966-1983 were sought in both the Register and MEDLINE files. Comparison of subject searches revealed a number of unlisted papers in each file that were then found to be present by an author search. In the MEDLINE searching an amateur was clearly less efficient than an expert, but the expert recovered only 29% of the relevant hyperbilirubinemia papers available in MEDLINE, and only 56% of the identified IVH RCTs. Some of the deficiencies in recovery have been corrected by indexing improvements, such as the capability of identifying text words in abstracts, and the addition of new medical subject heading terms (MeSH) such as RANDOM ALLOCATION. Efficiency will be best facilitated by authors and editors keeping the MeSH terms used by MEDLINE indexers in mind when they compose titles and abstracts.

Cerebral Hemorrhage↗

PubMed1987

Comparative multicentre study of the immunogenicity of different hepatitis B vaccines in healthy volunteers.

In a comparative study of the immunogenicity of different hepatitis B vaccines, 339 healthy seronegative adults at three different centres were randomly allocated to receive either three doses of a yeast-derived vaccine at one of three different dose levels (10, 20, or 40 micrograms; SmithKline Biologicals) or one of two commercial plasma-derived vaccines at standard dose levels (5 micrograms, Institut Pasteur Production or 20 micrograms, Merck Sharp & Dohme). The subjects were inoculated intramuscularly in the deltoid region according to a 0, 1, and 6 month schedule. No severe or serious adverse reactions attributed to any of the vaccines were observed. One month after the third vaccine dose, seroconversion rates ranged from 95% to 100% in all groups with only 6 subjects failing to seroconvert. Although there were no statistically significant intra-centre differences in antibody levels, the Tours/Chateauroux groups generally attained higher antibody levels than those from Limoges for the same yeast-derived vaccine dose. This unexplained difference between centres was not found for the plasma-derived vaccines. Older subjects responded less well than younger ones and females attained higher antibody levels than did males. The yeast-derived vaccine is comparable to the two commercially available plasma-derived vaccines in terms of reactogenicity and immunogenicity.

Adult↗

PubMed1989

Intercostal blockade and pulmonary function after cholecystectomy.

Sixty-six patients undergoing cholecystectomy were randomly allocated to receive either intercostal blockade with bupivacaine supplemented with papaveretum or papaveretum alone for postoperative analgesia. Both groups were similar regarding distribution of sex, age, and weight. These two groups were compared. Patients who did not have intercostal blockade required postoperative analgesia sooner. There was no significant difference, however, in the total consumption of papaveretum. Both groups experienced similar degrees of pain, and there were no differences in postoperative pulmonary function. We conclude that although single intercostal blockade is an effective analgesic, it does not improve pain relief and does not improve pulmonary function after cholecystectomy when compared with a regimen of on-demand, intramuscularly administered papaveretum.

Analgesia↗

PubMed1990

Comparison of reactogenicity and antigenicity of M37 rotavirus vaccine and rhesus-rotavirus-based quadrivalent vaccine.

90 Venezuelan infants aged 10-20 weeks were randomly allocated to four groups which received one of the following: the M37 vaccine (1 x 10(4) pfu [plaque-forming units]); quadrivalent rotavirus vaccine (1 x 10(4) pfu each of serotype 3 rhesus rotavirus [RRV] and human rotavirus-RRV reassortants of serotypes 1, 2, and 4); balanced quadrivalent vaccine consisting of 1 x 10(4) pfu of serotype 1 and 3 components but 5 x 10(4) pfu of serotype 2 and 4 components; or placebo. The frequencies of transient febrile responses in these four groups were 20%, 27%, 30%, and 9%. 50% of 22 infants tested who received M37 vaccine showed a serum rotavirus IgA antibody response, compared with 74% of the 23 quadrivalent and 86% of the 22 balanced-quadrivalent recipients. 64% of the M37 recipients showed a neutralising antibody response to M37; 27% showed such responses to human serotype 1 Wa strain and 27% to serotype 4 neonatal strain ST3. 17-39% of the quadrivalent recipients and 27-41% of the balanced-quadrivalent recipients showed neutralising antibody responses to serotypes 1-4. 70-73% of the quadrivalent and balanced quadrivalent groups also showed neutralising antibody responses to RRV.

Antibodies, Viral↗

PubMed1999

A comparison of the educational opportunities on junior medical attachments in general practice and in a teaching hospital: a questionnaire survey.

OBJECTIVES: To obtain students' perceptions of the educational quality of the general internal medicine teaching overall and to determine whether specific learning objectives were better addressed in general practice or in hospital. DESIGN: The survey was carried out after a 10 week block of general internal medicine, consisting of five weeks taught in general practice and five weeks taught in a teaching hospital. Students were randomly allocated to start in either general practice or hospital. The outcome measure was a questionnaire survey of students perceptions' of their learning on the two halves of the block. Each student completed the same questionnaire twice: once after their hospital experience and once after their general practice experience. Statistical Analysis was carried out using the SPSS package for Windows 3.1. Group means were calculated for each response, and the mean differences for each student's responses for the two learning environments were analysed using t-tests for paired samples. SETTING: Royal Free and University College Medical School at University College London. SUBJECTS: The study population was the entire annual intake (n = 225) of students into the first clinical year at one UK medical school. RESULTS: Students perceived they learnt more about history taking and physical examination in the community, whereas they learnt more about writing up their clerkings, keeping progress notes and disease management in hospital. CONCLUSIONS: The community and hospital environments appear to have different strengths for the teaching of medical students. These data support judicious transfer of clinical skills teaching from teaching hospitals into general practice, when the circumstances achieved here can be duplicated. However, some aspects of the clinical attachment, particularly record keeping and disease management, are probably better taught in hospital at present.

Clinical Medicine↗

PubMed1987

Experimental study of two methods of data collection by questionnaire.

The aim of the present study was to compare the results obtained using two different methods of data collection about caries preventive services provided in general dental practice. A questionnaire was mailed to a random national sample of 479 dentists resident in Norway in January 1985. The sample was divided into two groups by random allocation. All dentists, irrespective of group, were requested to give background information. One group, comprising 287 dentists (GR), was asked to complete a separate form for every adult patient (greater than or equal to 20 yr) treated in the course of 1 day. The demographic characteristics and dental visiting habits of the patients, as well as the number of teeth present, caries lesions and preventive services rendered were recorded. The other group, 192 dentists (GE), was requested to make general estimates of the time spent on caries prevention and the proportion of patients receiving various types of caries preventive services. The dentists were unaware of the methodologic aspect of the survey and everyone received one reminder in order to guarantee anonymity. The estimation method (GE) did not give the expected advantage over the registration method (GR) in response rate (51.7% vs 46.2%, P greater than 0.40), and gave a gross overestimation of the frequency with which adult patients received different types of caries preventive procedures (P less than 0.005). Thus, even though the estimates of the proportion of total treatment time spent on caries prevention were comparable for the two methods, and the estimation approach is labor-saving, it cannot be recommended for the collection of data on caries prevention in the dental office.

Adult↗

PubMed1983

Regional intravenous guanethidine vs. stellate ganglion block in reflex sympathetic dystrophies: a randomized trial.

Regional intravenous guanethidine blocks and stellate ganglion blocks have been compared in a randomized trial. Nineteen patients, randomly allocated to two groups of therapy and exhibiting severe reflex sympathetic dystrophy following peripheral nerve lesions, have been treated. The performance of the intravenous guanethidine block is of longer duration and superior to stellate ganglion block, as regards some early pharmacological effects (skin temperatures and amplitude of plethysmographic waves recorded before blockade and 15 min, 60 min, 24 h, 48 h after institution of the block). In fact the intravenous guanethidine group shows a persistent and significant increase of the skin temperature and of the plethysmographic traces in the blocked side 24 h and 48 h after blockade in comparison with the patients treated with stellate ganglion block. Concerning the therapeutic effects (changes in pain scores and clinical signs--hyperpathia, allodynia, vasomotor disturbances, trophic changes, oedema and limited motion), recorded at the end of treatment and 1 month and 3 months follow-up, an intravenous guanethidine block carried out every 4 days up to a total of 4 blocks is comparable with a stellate ganglion block every day up to a total of 8 blocks. The results of this study show that regional sympathetic block with guanethidine is a good therapeutic tool in the treatment of reflex dystrophies, especially on account of its negligible risks and contraindications.

Adult↗

PubMed1981

Urokinase or heparin in the management of patients with deep vein thrombosis?

Twenty patients with clinical signs of deep vein thrombosis of a duration not exceeding 72 hours, and with the condition confirmed phlebographically, were randomly allocated to one of two groups in a double-blind study. In group 1 the patients received urokinase in a low-dose regimen of 200 000 Ploug units during the first 24 hours, followed by infusion of heparin, 40 000 units daily during the next 5 days. Patients in group 2 received heparin only, 40 000 units daily for 6 days. The clinical course was assessed daily. When the infusion period was completed, the phlebography was repeated, and the results of the two examinations were compared with respect to extent of filling defects and the degree of non-filling of the deep veins. We found no superiority in the regimen consisting of urokinase preceding heparin infusion, compared with that of heparin infusion alone. Most of the patients improved clinically during the 6-day infusion period, but the degree of thrombosis, evaluated phlebographically, was unaltered or even deteriorated during the period in all patients except two. Overt bleeding was noted in 6 patients.

Clinical Trials as Topic↗

PubMed1989

[Omeprazole (20 mg daily) compared to ranitidine (150 mg twice daily) in the treatment of esophagitis caused by reflux. Results of a double-blind randomized multicenter trial in France and Belgium].

We report the results of a trial of omeprazole 20 mg daily versus ranitidine 150 mg b.i.d. in the short-term management of erosive or ulcerative esophagitis. The principal aim of the trial was to assess the healing rates of the esophageal lesions. The trial was conducted in 19 centers (16 in France and 3 in Belgium). The lesions of the esophageal mucosa were defined as follows: grade 2 (n = 112), round or linear erosions; grade 3 (n = 33), confluent erosions affecting the total esophageal circumference; or grade 4 (n = 11), erosions as described above plus deep ulcerations or peptic stenosis which did not need endoscopic dilatation. The main criterion was the complete healing of esophageal lesions after 4 weeks of treatment. Patients were randomly allocated to double-blind treatment with omeprazole or ranitidine. Clinical and endoscopic examinations were done on inclusion in the trial and at day 29 +/- 6, and again at day 57 +/- 6 if esophagitis was unhealed. No patient was excluded from the analysis on an "intention-to-treat" basis, and 25 patients were excluded from the "per protocol" analysis, mainly because of poor compliance with the trial protocol. The healing rate at weak 4 was 50 of 62 patients (81 p. 100) treated with omeprazole and 31 of 69 patients (45 p. 100) with ranitidine (p less than 0.001). The corresponding figures at week 8 were 58 of 61 (95 p. 100) and 40 of 61 (65 p. 100) (p less than 0.001).

Belgium↗

PubMed1989

Limitation of myocardial infarct size and preservation of left ventricular function by early administration of APSAC in myocardial infarction.

In cases of acute myocardial infarction (MI), it has been shown that preserving left ventricular function and limiting infarct size with early reperfusion of the occluded artery by means of a thrombolytic agent could eventually result in a reduced mortality rate. The aim of the APSIM study (anisoylated plasminogen streptokinase activator complex [APSAC] dans l'infarctus du Myocarde) was to demonstrate that early administration of APSAC in patients with recent acute MI could limit the infarct size and preserve left ventricular systolic function. In all, 231 patients with a first acute MI were randomly allocated to either APSAC (30 U over 5 minutes) or to conventional heparin therapy (5,000 IU in bolus injection) within 5 hours of the onset of symptoms. Of these patients, 112 received APSAC and 119 received heparin within a mean period of 188 +/- 62 minutes after the onset of symptoms. The patency rate of the infarct-related artery was 77% in the APSAC group and 36% in the heparin group (p less than 0.001). Left ventricular ejection fraction determined from contrast angiography was significantly higher in the APSAC than in the heparin group. This was true for the entire population (0.53 +/- 0.13 vs 0.47 +/- 0.13, p = 0.002) as well as for the subgroups of anterior and inferior wall infarctions (0.47 +/- 0.13 vs 0.4 +/- 0.16, p = 0.004 and 0.56 +/- 0.11 vs 0.51 +/- 0.09, p = 0.02). At 3 weeks, the difference remained significant for patients with anterior MI.(ABSTRACT TRUNCATED AT 250 WORDS)

Anistreplase↗

PubMed1988

Ethinylestradiol and desogestrel, alone or in combination with two doses of estriol. Effects on plasma proteins.

Nineteen fertile women were treated with three differently composed oral contraceptives in a cross-over study and were randomly allocated to begin with one of the three preparations. The tablets contained 0.030 mg ethinylestradiol +0.15 mg desogestrel alone (A) or in combination with either 0.5 mg estriol (B) or 2 mg estriol (C). After two treatment cycles on each preparation, blood samples were obtained and analysed for ceruloplasmin, SHBG, prealbumin, transcortin and thyroxine-binding globulin. No differences were found in the induction of liver protein synthesis. It was concluded that the addition of estriol in doses of 0.5 or 2 mg did not influence the effects induced by ethinylestradiol.

Adolescent↗

PubMed1985

Staples or sutures for low colorectal anastomoses: a prospective randomized trial.

One hundred and eighteen patients undergoing low colorectal anastomoses were randomly allocated to reconstitution by either single layer interrupted extramucosal sutures or circular staple gun. In the 60 patients undergoing sutured anastomosis there were 2 (3 per cent) clinical leaks and 4 (7 per cent) radiological leaks, and no failures. Of the 58 patients who underwent stapled anastomosis there were 4 failures, 7 (12 per cent) clinical leaks, 14 (24 per cent) radiological leaks and 1 death. Stapled anastomoses were more than ten times as expensive as sutured anastomoses and there were no savings in time or numbers of associated colostomies. An interrupted extramucosal suture technique remains the ultimate standard for low colorectal anastomosis.

Adult↗

PubMed1989

Comparison of increase in the enalapril dose and addition of hydrochlorothiazide as second-step treatment of hypertensive patients not controlled by enalapril alone.

Forty-six patients were randomly allocated to two different groups of treatment if their diastolic blood pressure remained above 90 mm Hg after one month of treatment with 20 mg enalapril mg once daily. In the first group (ENA), 23 patients were given higher daily dosages of enalapril (40 mg and, when necessary, 60 mg). The second group of 23 patients (HCTZ) was given 20 mg/day enalapril and hydrochlorothiazide (25 mg/day and, when necessary, 50 mg). Blood pressure was measured by an automatic device and by the physician with a standard sphygmomanometer. Blood pressure was significantly lower in the HCTZ group, according to both the automatic device (130 +/- 9/80 +/- 8 vs. 141 +/- 5/86 +/- 8 mm Hg, p less than 0.01/p less than 0.05) and the sphygmomanometer (134 +/- 10/89 +/- 6 vs. 149 +/- 16/94 +/- 5 mm Hg, p less than 0.001/p less than 0.01). Plasma renin activity, increased by enalapril at the 20 mg dosage, rose in the HCTZ group but not in the ENA group (22.4 +/- 22 vs. 10.2 +/- 11 pmol/ml/h, p less than 0.05). Plasma aldosterone increased significantly in the HCTZ group (0.44 +/- 0.22 vs. 0.30 +/- 0.17 pmol/ml, p less than 0.05) but did not change in the ENA group (0.31 +/- 0.11 vs. 0.30 +/- 0.17 pmol/ml, NS). In the ENA group, converting enzyme activity was not reinforced (5.7 +/- 8 vs. 6.6 +/- 6 mU/ml, NS) despite an increase in plasma enalaprilat levels (172.4 +/- 108 vs. 72.1 +/- 42 ng/ml, p less than 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)

Angiotensinogen↗

PubMed1990

Chemotherapy versus tamoxifen versus chemotherapy plus tamoxifen in node-positive, estrogen receptor-positive breast cancer patients: results of a multicentric Italian study. Breast Cancer Adjuvant Chemo-Hormone Therapy Cooperative Group.

Between November 1, 1983 and June 30, 1987, 510 node-positive, estrogen receptor (ER)-positive breast cancer patients have been randomly allocated to receive either chemotherapy (six intravenous [IV] cyclophosphamide, methotrexate, and fluorouracil [CMF] courses followed by four IV epirubicin courses) or 5 years of tamoxifen treatment or a combination of both therapies. After a median follow-up of 40 months, patients receiving the combined treatment achieved the best results, and those treated with chemotherapy alone achieved the worst, the difference being particularly evident in postmenopausal women. However, while the concurrent use of chemotherapy and tamoxifen did improve the results achieved by chemotherapy alone, particularly in postmenopausal women and in those with four or more involved nodes, it did not significantly improve the results achieved by tamoxifen alone, particularly in patients with higher ER tumor concentrations. Side effects were more numerous and more severe in patients receiving chemotherapy (with or without tamoxifen). Our findings, although still preliminary, confirm that tamoxifen should be the treatment of choice for postmenopausal breast cancer patients with node-positive, ER-positive tumors. In addition, the findings suggest that tamoxifen may represent a safe alternative to chemotherapy (at least to the cytotoxic regimen we used) for younger women, provided they have ER-positive tumors. In patients with ER-positive tumors, the addition of chemotherapy to tamoxifen does not seem to improve significantly the effectiveness of tamoxifen alone.

Adult↗

PubMed1985

[Famotidine versus ranitidine in the acute treatment of duodenal ulcer. A multicenter comparative study in Germany].

185 patients with endoscopically proven duodenal ulcers were randomly allocated to treatment with either famotidine 40 mg nocte, 20 mg bid, 40 mg bid or ranitidine 150 mg bid for 2-8 weeks in a prospective double-blind study. The four groups were similar with regard to age, sex, duration of ulcer disease, smoking habits etc. After 2 weeks treatment 28/42 patients (66.7%) healed on famotidine 40 mg nocte, 24/42 patients (57.1%) on famotidine 20 mg bid, 26/41 patients (63.4%) on famotidine 40 mg bid and 28/43 patients (65,1%) on ranitidine 150 mg bid. The corresponding healing rates after 4 weeks were 90.5%, 83.3%, 90.2% and 93%, respectively. After 8 weeks more than 93% of the patients had healed ulcers. At each time there was no statistical difference between the different famotidine regimens and the ranitidine group. All treatments were well tolerated and severe adverse events were rare. Famotidine 40 mg at night, therefore, appears to be as good as conventional ranitidine.

Adolescent↗