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 703 records · Page 39Linked to original sources

PubMed1987

Short-term treatment of reflux oesophagitis with ranitidine 300 mg nocte. Italian multicentre study.

A multicentre study involving 9 Italian institutions was carried out to compare the efficacy and safety of ranitidine 150 mg b.i.d. and ranitidine 300 mg nocte in the treatment of reflux oesophagitis. 117 patients with histologically proven oesophagitis were randomly allocated to two comparable treatment groups. Efficacy and reliability were evaluated by clinical and laboratory tests at the beginning of the study, and at 3 and 6 weeks; endoscopy and biopsies were performed at the beginning and at 6 weeks. Treatment with ranitidine for 6 weeks led to total disappearance of gastro-oesophageal reflux symptoms in 60% of patients, with percentages of partial improvement varying between 85% and 95% of cases. Improvement in the results of endoscopic examination was 85%, of which 55% were cured. Microscopic examination revealed an improvement of 36% and 44%, with a cure rate of 18% and 26% respectively. With regard neither to the regression of symptoms nor to the macroscopic and microscopic inflammation of the oesophageal mucosa did statistical examination show significant differences in the therapeutic efficacy of ranitidine 150 mg b.i.d. or 300 mg nocte for treatment of reflux oesophagitis.

Adult↗

PubMed1989

Ketanserin in the treatment of systemic sclerosis: a double-blind controlled trial.

In a randomized, double-blind study, the selective and specific S2-serotonergic receptor antagonist, ketanserin was compared with placebo in 24 patients with systemic sclerosis. Following a 6-week placebo washout period, patients were randomly allocated to receive ketanserin or placebo for 6 months. Ketanserin failed to produce a greater improvement than placebo in functional and objective clinical signs and symptoms as well as in most subjective assessments. However, in a global rating by the physician ketanserin was superior to placebo. No difference in the frequency or severity of side-effects was found. The results cast doubt on the hypothesis that serotonin may be a major contributing factor in the pathophysiology of systemic sclerosis.

Adult↗

PubMed1987

Exercise training of men at retirement: a clinical trial.

The effects of one year of exercise training on cardiorespiratory fitness, levels of daily leisure activity, and blood lipids (cholesterol and high density lipoproteins) were studied in a prospective, randomized clinical trial. Two hundred and twenty-four men aged 55 to 65 years volunteered for the study and were randomly allocated to a control (n = 111) or an activity (n = 113) group with stratification on blue or white collar job classification. After the attrition due to loss to follow-up, 100 men remained in each of the control and activity groups. The exercising men met an average of 2.5 times per week over the year and their VO2 max or peak VO2 (ml X kg-1 X min-1) increased significantly (p = .001, 11%) compared with controls. There were no significant changes in maximal heart rate (155 bpm) and respiratory exchange ratio (1.1), although ventilation (80 to 90 l X min-1) increased significantly in the trained group. In addition, the VO2 at a heart rate of 125 bpm increased significantly (p less than .001) in the trained group (14.7%) over that observed in the control (1.9%). There were no significant differences between the groups with respect to the remaining end-points.

Blood Pressure↗

PubMed1984

A double blind study of imipramine versus zimelidine in treatment of obsessive compulsive neurosis.

Six patients suffering from obsessive compulsive neurosis were randomly allocated into two groups of three patients each and commenced on either imipramine, a noradrenaline re-uptake inhibitor, or zimelidine, a serotonin re-uptake inhibitor. After 4 weeks, the group on zimelidine showed significant reduction of obsessional symptoms as compared to the other group. The response was rapid and sustained over a period of two months.

Adult↗

PubMed1988

The BBB study: a prospective randomized study of intensified antihypertensive treatment. The BBB study group.

The BBB study is a multicentre trial designed to investigate three aspects of antihypertensive treatment of great clinical importance: (1) Is it possible to lower diastolic blood pressure further in treated hypertensive patients (to less than or equal to 80 mmHg) through intensified therapeutic activities? (2) Can this aim be fulfilled without increasing the incidence or severity of side effects to unacceptable levels? (3) If 1 and 2 are answered in the affirmative, will the reduction in diastolic blood pressure give a further reduction in hypertension-associated mortality and morbidity? The BBB study is a prospective trial in which male and female treated hypertensive patients, aged 45-67 years, with treated diastolic blood pressures in the range 90-100 mmHg, will be randomly allocated to either unchanged antihypertensive treatment or intensified treatment with the aim of lowering the diastolic blood pressure to less than or equal to 80 mmHg. Statistical calculations indicate that approximately 2000 patients studied for 3 years will be needed to answer the third question. For this reason the trial will be conducted as a multicentre study performed mainly by primary health care physicians.

Aged↗

PubMed1989

Simvastatin (MK 733): an effective treatment for hypercholesterolemia.

This study describes the efficacy of the drug simvastatin. It is likely to be the first HMG CoA reductase inhibitor in Australia and New Zealand available for the treatment of hyperlipidemia. Twenty-four patients, 12 men and 12 women with primary hypercholesterolemia were randomly allocated to treatment by cholestyramine (eight patients) or to simvastatin (16 patients) for a 12-week period. With simvastatin, total cholesterol levels decreased by 37.5% from a baseline mean of 10.33 mmol/L to 6.4 mmol/L after 12 weeks. Low density lipoprotein (LDL) cholesterol concentration decreased by 48.2% from 8.40 mmol/L to 4.39 mmol/L. These effects were better than observed for cholestyramine alone where cholesterol and LDL-cholesterol reductions were 24.9% and 33.1% respectively. Thirteen patients, however, did not achieve target LDL levels of 3.62 mmol/L, or below, and therefore were treated with a combination of cholestyramine and simvastatin, resulting in a decrease of total cholesterol and LDL-cholesterol by 45.5% and 53.5% of baseline values studied over an eight-week period. No major clinical side-effects were encountered. One patient appeared to have had a change in colour vision at the end of the study at 20 weeks, without loss of visual acuity.

Adult↗

PubMed1994

Epistaxis and nasotracheal intubation--prevention with vasoconstrictor spray.

Eighty patients having anaesthesia for oral surgery requiring nasal intubation were randomly allocated to be intubated with either a plain Magill red rubber or cuffed polyethylene endotracheal tube and in a double blind manner, to receive xylometazoline 0.1% vasoconstrictor nasal spray. The extent of any epistaxis occurring was assessed by an independent observer. With the Magill tube there was bleeding in one out of twenty patients in both the vasoconstrictor group and non vasoconstrictor group at intubation and no bleeding in either of the two groups at extubation. With the polyethylene tube sixteen out of twenty patients had bleeding in the non vasoconstrictor group. This improved to seven out of twenty with the administration of vasoconstrictor drops at intubation (chi square 10.2; p < 0.01) in the polyethylene tube group. At extubation ten out of twenty patients had bleeding in the non vasoconstrictor group improving to two out of twenty with the administration of the vasoconstrictor (chi square 9.6; p,0.01). The use of the vasoconstrictor xylometazoline helped to reduce epistaxis that occurred during nasal intubation and further study into the type of endotracheal tube is recommended.

Adolescent↗

PubMed1986

Metoprolol or hydrochlorothiazide in patients with hypertension aged 60-75 years. With special reference to assessment of compliance. Hunter Hypertension Research Group.

The blood pressure of patients with hypertension who were aged between 60 and 75 years responded equally well to treatment with metoprolol (100 mg a day) or hydrochlorothiazide (25 mg a day) in a double-blind study which employed random allocation to two parallel groups. Drug-related variables other than blood pressure were used as markers of compliance. The resting heart rate alone discriminated substantially between the groups, but the discrimination was not increased by the inclusion of plasma potassium or plasma urate levels in the calculation. For the assessment of compliance, we suggest that greater use could be made of objective variables that are altered by drug treatment and are unrelated to the primary variable of interest in the study.

Aged↗

PubMed1992

Effects of diets rich in monounsaturated fatty acids on plasma lipoproteins--the Jerusalem Nutrition Study. II. Monounsaturated fatty acids vs carbohydrates.

Seventeen male Yeshiva students were randomly allocated to a crossover study with two 12-wk dietary periods of monounsaturated fatty acids (MUFAs) vs a carbohydrate (CHO)-rich diet while concentrations of saturated (SFAs) and polyunsaturated (PUFAs) fatty acids were kept similar. Total plasma cholesterol (TC) decreased significantly by approximately 7.7% and low-density-lipoprotein cholesterol (LDL-C) by 14.4% on the MUFA diet, whereas on the CHO diet no significant change in cholesterol concentrations occurred, in contrast to that predicted by the equations of Keys and Hegsted. Concentrations of high-density-lipoprotein cholesterol (HDL-C) did not change significantly on either diet. On the MUFA diet there was a significantly lower proneness to peroxidation of plasma and LDL lipids and less extensive metabolism of conditioned LDL by peritoneal macrophages. We conclude that dietary MUFAs lower TC and LDL-C concentrations, independently of other dietary fatty acids and in addition may reduce the susceptibility of LDL to oxidative stress.

Adult↗

PubMed1987

Maternal posture in second stage and fetal acid base status.

The effect of position during the second stage on outcome was studied in 58 women, with no exclusions because of pregnancy complications or signs of fetal distress, who were randomly allocated to have the second stage conducted in either the dorsal or 15 degrees lateral tilt position. All the women were of parity 0 or 1 and the two groups were well matched except for gestational age at delivery. There were no differences in clinical outcome between the two groups, but overall the dorsal group had lower cord artery pH values (P less than 0.05), higher PCO2 (P less than 0.01) and a greater base deficit, but not significantly so. pH and base deficit were similar in both groups where the second stage did not last greater than 15 min. Thereafter, there was a trend to decreasing pH and increasing base deficit with increasing length of second stage in the dorsal group, but not in the tilt group though this did not reach statistical significance. Low Apgar scores, complicated pregnancy and first pregnancy were each associated with significantly lower pH levels. Prolonged placement of the patient in the flat dorsal position should be avoided in second stage, though a suitable alternative under the conditions described has not been defined.

Adult↗

PubMed1987

PUVA, etretinate, and PUVA-etretinate therapy for pustulosis palmoplantaris. A placebo-controlled comparative trial.

Thirty patients with severe pustulosis palmoplantaris completed a placebo-controlled comparative trial. Patients were randomly allocated to placebo or etretinate therapy; after two weeks, psoralen plus long-wave ultraviolet light (PUVA) treatment was instituted on one hand or foot, while the other hand or foot served as an untreated control. Fourteen of 18 hands or feet cleared with the combined treatment, compared with three of 18 with etretinate treatment and three of 12 with PUVA treatment. Follow-up showed a high relapse rate. Treatment of severe pustulosis palmoplantaris must be individualized to minimize short- and long-term side effects.

Adult↗

PubMed1990

Salivary oestradiol and progesterone after in vitro fertilization and embryo transfer using different luteal support regimens.

Salivary oestradiol (E2) and progesterone (P) levels have been shown to reflect the biologically active fractions in the serum. The luteal-phase status of stimulated cycles was investigated after in vitro fertilization and embryo transfer (IVF-ET). Thirty patients were randomly allocated to one of three luteal therapy groups: group A had no support, group B had intramuscular P and group C had intramuscular P and human chorionic gonadotrophin (hCG). One pregnancy was achieved in group A, two in group B and three in group C. Significant correlations between salivary and serum levels of E2 and of P in matched samples during luteal phase were found. Salivary E2 levels from luteal day 8 through day 14 and P levels from day 3 through day 14 were significantly higher in the pregnant than in the nonpregnant cycles. Among the nonpregnant cycles, salivary E2 and P levels were significantly higher in group C than in group A or B. These findings suggest that, in stimulated cycles for IVF-ET, determination of salivary E2 and P levels may be used as reliable alternatives to serum concentrations for assessing the luteal phase. Also, the additional hCG has an enhanced luteotrophic effect, as reflected by the higher salivary E2 and P levels, which may lead to a better pregnancy rate.

Chorionic Gonadotropin↗

PubMed1991

Effect of enalapril on allergen-induced cutaneous hypersensitivity reaction.

1. To test the hypothesis that the in vivo inhibition of angiotensin converting enzyme in a patient who presents atopy, results in a significant increase in cutaneous bradykinin and prostaglandin production, the effect of enalapril on the cutaneous hypersensitivity reaction was examined in 10 atopic volunteers. 2. A crossover study design was used and volunteers were randomly allocated to treatment with either enalapril (10 mg) alone, or in combination with indomethacin (75 mg), with and without ketotifen (1 mg). Drugs were administered twice daily for 2 days. 3. Allergen (Southern Grass Mix) was administered intradermally 2 h after last drug dosage and the surface areas of the immediate wheal-and-flare-reactions were measured 15 min later. The late phase of the cutaneous response was evaluated 6 h later by determining skinfold thickness and surface area. 4. Enalapril alone had no effect on any of the parameters measured. 5. The cutaneous hypersensitivity reaction was significantly reduced with regard to both immediate and late cutaneous responses when the indomethacin and ketotifen combination was added to enalapril therapy. 6. When only indomethacin was added to enalapril pretreatment the flare reaction was significantly reduced, but whealing was unaffected. 7. This study presents further evidence that mast cell mediators other than prostaglandins are involved in the cutaneous hypersensitivity reaction. Furthermore, that endogenous bradykinin production after enalapril pretreatment either never reaches the supraphysiological concentrations used in previous experiments, or that bradykinin is rapidly and effectively broken down to inactive peptides by other carboxypeptidase enzymes.

Administration, Oral↗

PubMed1983

Trial of maximal anal dilatation, cryotherapy and elastic band ligation as alternatives to haemorrhoidectomy in the treatment of large prolapsing haemorroids.

A selected group of 112 patients with prolapsing haemorrhoids which had failed to respond to injections of phenol in oil or which required manual replacement after defecation, were randomly allocated treatment by haemorrhoidectomy, maximal anal dilation, elastic band ligation or cryotherapy. When results were assessed 5 weeks after treatment, haemorrhoidectomy and maximal anal dilatation were equally effective in reducing symptoms, although more physical signs remained after maximal anal dilatation; cryotherapy and elastic band ligation were less effective in both respects. When patients were followed up between 6 months and 5 years haemorrhoidectomy was found to be the most effective method. Patients in the other three groups developed recurrent symptoms requiring haemorrhoidectomy.

Adult↗

PubMed1985

Blood pressure and dietary polyunsaturated and saturated fats: a controlled trial.

Fifty-four healthy, omnivore normotensive volunteers aged 20-59 years were randomly allocated either to a control group eating a low polyunsaturated to saturated fat ratio (P/S ratio) diet (0.3) throughout, or to one of two experimental groups eating a high P/S ratio diet (1.0) for one of two 6-week experimental periods. Changes in other components were avoided. Twenty-four hour diet records showed substantial changes in the P/S ratio for experimental groups when on the high P/S ratio diet (0.3 to 1.0). There were significant increases in relative concentrations of linoleic acid in plasma phospholipids when on the high P/S ratio diet. There was no consistent effect of dietary P/S ratio elevation from 0.3 to 1.0 on group mean systolic and diastolic blood pressures. Adjustment of blood pressure changes for changes in electrolytes, other dietary components, plasma lipids, weight and other lifestyle variables did not alter this result. It was concluded that the blood pressure lowering effect of a vegetarian diet reported previously was unlikely to have been due to changes in dietary P/S ratio.

Adult↗

PubMed1984

Segmental phenolization of ingrowing toenails: a randomized controlled study.

One hundred and three patients, on whom 107 procedures for ingrowing toenails were performed, were randomly allocated into one of two treatment groups: segmental or angular phenolization and wedge excision. There were 53 wedge excisions and 54 segmental phenolizations. Post-treatment discomfort was assessed on a linear analogue scale of 10 cm. There was no difference between the two groups one week after treatment. Over a mean follow-up period of 14 months a total of 20 nail spikes occurred, 4 in the phenolized group and 16 in the wedge excision group, this being a significant difference at the one per cent level.

Adult↗

PubMed1989

Antibiotic exposure delays intestinal colonization by Clostridium difficile in the newborn.

Two antibiotic regimens commonly used in neonatal intensive care were compared for the rate at which Clostridium difficile appeared in the faeces. Over a nine month period neonates with suspected sepsis admitted to a Special Care Baby Unit (SCBU) were randomly allocated to receive either cefotaxime or penicillin and netilmicin. A contemporaneous group also admitted to SCBU but without sepsis served as non-treated controls. Four hundred and sixteen stool specimens from 158 neonates without diarrhoea were analysed every five to seven days until discharge. The results showed that these antibiotics did not encourage gut colonization by C. difficile, that they might even be protective in this respect and that monotherapy with cefotaxime was no more likely to generate C. difficile overgrowth than the penicillin-aminoglycoside regimen.

Anti-Bacterial Agents↗

PubMed1990

Simvastatin in the treatment of hypercholesterolaemia in patients with essential hypertension.

Mortality from coronary artery disease is a common problem in treated hypertensive patients, and these people have a high prevalence of elevated cholesterol levels. A study was undertaken to determine whether cholesterol could be lowered effectively without major side effects in patients with treated hypertension. Forty-nine patients (mean age 67.6 years) with cholesterol greater than 5.5 mmol/l were placed on a reduced-fat (less than 30% of calories from fat with a ratio of polyunsaturated to saturated fats of less than 1) diet for 3 months. If the cholesterol was between 5.5 and 7.5 mmol/l and total cholesterol divided by high-density lipoprotein cholesterol was greater than 4.5, the patients were randomly allocated either to the simvastatin (24 patients) or the placebo group (25 patients). Diet and placebo caused minor and insignificant falls in cholesterol and no change in triglycerides or lipids. Treatment with simvastatin reduced cholesterol levels from 6.85 to 4.75 mmol/l (P less than 0.001), triglycerides from 2.7 to 2.1 mmol/l (P less than 0.01), low-density lipoproteins from 4.6 to 2.6 mmol/l (P less than 0.001) and high-density lipoproteins rose from 1.09 to 1.18 mmol/l (P less than 0.01). Total cholesterol divided by high-density lipoprotein cholesterol fell from 6.3 to 4.0 (P less than 0.001). The drug was well tolerated and the side-effect profile did not differ from the placebo in clinical or biochemical events. The active drug was stopped in one patient (abdominal pain, dizziness, headache, tiredness) and in two patients taking the placebo (elevated creatine phosphokinase, cardiovascular collapse). Simvastatin effectively lowered total cholesterol and improved the lipoprotein profile. The dose required in most patients was 40 mg/day. Simvastatin may be an acceptable drug to improve the lipoprotein profile in order to determine whether this improves the prognosis in patients treated for hypertension.

Adult↗