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Double-blind trial of pirenzepine in acute pancreatitis.

A double-blind clinical trial was carried out to evaluate the efficacy of pirenzepine (PZ) in acute pancreatitis (AP). One hundred and fifteen patients were randomly allocated in three groups, comparable in number, clinical and biochemical parameters. All were hydrated and received nasogastric suction. Group A was the control, groups B and C received additionally 10 and 20 mg of PZ intravenously every 12 h, respectively. PZ-treated patients showed benefit, with a significant difference (p less than 0.01) in the duration of hyperamylasemia and the duration of pain tending to be significantly reduced (p = 0.054). PZ influenced significantly (p less than 0.01) the plasma amylase levels and caused no major adverse effects. Complications were less frequent and mortality was reduced in patients who received PZ. Thus, the use of PZ in AP appears to be beneficial and safe; however, these preliminary results deserve further confirmation before a general recommendation to treat such patients can be made.

Acute Disease↗

A prospective randomized study of continuous peritoneal lavage postoperatively in the treatment of purulent peritonitis.

Peritoneal lavage performed postoperatively in the treatment of purulent peritonitis was evaluated in a prospective randomized study. Patients with free purulent peritonitis due to perforated appendicitis or colonic perforation were treated with intravenous infusion of cefuroxime and metronidazole. The patients were randomly allocated to treatment with or without continuous postoperative peritoneal lavage. The patients were kept under observation for postoperative septic intra-abdominal complications. Of the 79 patients, 41 were treated with lavage postoperatively and 38 were not. No postoperative abscess or other septic intra-abdominal complication was found in any patient. In ten, the postoperative lavage was interrupted because of technical complications or complaints of discomfort by the patient. In this study, no clinical benefit of continuous peritoneal lavage postoperatively in the treatment of purulent peritonitis was noted. Lavage done postoperatively is expensive and seems to carry a risk of complications. Thorough rinsing of the infected abdominal cavity perioperatively and adequate antibiotic treatment, including an antianaerobic agent, seem to be effective in preventing intra-abdominal septic complications.

Adult↗

Acebutolol and oral surgery: plasma levels following a single oral dose.

Twenty eight patients were randomly allocated into treatment or placebo groups. The treatment group received a single 400 mg oral dose of acebutolol, the placebo group an identical inert prepation. A blood sample from each patient was subsequently analysed for plasma concentrations of acebutolol and diacetolol, and the electrocardiogram was continuously monitored for changes of rate and rhythm. The plasma concentrations of acebutolol and diacetolol were all above the previously reported minimum levels for effective dysrhythmia control and the nine patients in whom irregularities of rhythm occurred were all in the placebo group. One patient in the treatment group, who was 58 years old, required intravenous injection of atropine for bradycardia and hypotension after induction of anaesthesia. It is suggested that in patients with small body weights and in those patients over 50 years of age the predmedication dose of acebutolol should be reduced to 200 mg.

Acebutolol↗

Blood-pressure-lowering effect of a vegetarian diet: controlled trial in normotensive subjects.

59 healthy, omnivorous subjects aged 25-63 years were randomly allocated to a control group, which ate an omnivorous diet for 14 weeks, or to one of two experimental groups, whose members ate an omnivorous diet for the first 2 weeks and a lacto-ovo-vegetarian diet for one of two 6-week experimental periods. Mean systolic and diastolic blood pressures did not change in the control group but fell significantly in both experimental groups during the vegetarian diet and rose significantly in the experimental group which reverted to the omnivorous diet. Adjustment of the blood-pressure changes for age, obesity, heart rate, weight change, and blood pressure before dietary change indicated a diet-related fall of some 5-6 mm Hg systolic and 2-3 mm Hg diastolic. Although the nutrient(s) causing these blood-pressure changes are unknown, the effects were apparently not mediated by changes in sodium or potassium intake.

Adult↗

Comparison of aminohydroxypropylidene diphosphonate, mithramycin, and corticosteroids/calcitonin in treatment of cancer-associated hypercalcaemia.

Thirty-nine patients with cancer-associated hypercalcaemia were randomly allocated to receive aminohydroxypropylidene diphosphonate (APD), mithramycin, or corticosteroids and salmon calcitonin. Corticosteroids/calcitonin had the fastest calcium-lowering effect, owing mainly to an acute reduction in renal tubular calcium reabsorption; continued therapy over 9 days failed to suppress accelerated bone resorption, however, and most patients remained hypercalcaemic. Mithramycin also substantially reduced serum calcium within 24 h. A further dose on day 2 generally controlled hypercalcaemia until day 6 by reducing both bone resorption and renal tubular calcium reabsorption. By day 9, however, about 50% of the mithramycin-treated patients had started to relapse as bone resorption increased again. With APD serum calcium levels fell more slowly but progressively owing to effective suppression of bone resorption; by day 9 the control of hypercalcaemia was significantly better than in the other treatment groups. Symptoms of hypercalcaemia were greatly relieved, especially by APD.

Calcitonin↗

Hypocholesterolemic effects of oat-bran or bean intake for hypercholesterolemic men.

Oat or bean products, rich in water-soluble fiber, have distinct hypocholesterolemic effects in humans. After a control diet, 20 hypercholesterolemic men were randomly allocated to oat-bran or bean supplemented diets for 21 days on a metabolic ward. Control and test diets provided equivalent energy, fat, and cholesterol but test diets had twice more total and 3-fold more soluble fiber. Oat-bran diets decreased serum cholesterol concentrations by 19% (p less than 0.0005) and calculated low-density lipoprotein cholesterol by 23% (p less than 0.0025). Bean diets decreased serum cholesterol concentrations by 19% (p less than 0.0005) and low-density lipoprotein cholesterol by 24% (p less than 0.0005). Oat-bran increased fecal weight by 43% but beans did not. While oat-bran increased fecal bile acid excretion, beans had the opposite effect. Oat-bran or bean supplements may have an important role in nutritional management of selected hypercholesterolemic patients.

Adult↗

Maternal and fetal haemodynamics in hypertensive pregnancies during maternal treatment with intravenous hydralazine or labetalol.

Intravenous treatment with 10 mg of hydralazine or 100 mg of labetalol was randomly allocated to 30 hypertensive pregnant women. Umbilical artery flow velocity waveforms were recorded using a pulsed Doppler duplex scanner (ATL Mk V) and umbilical artery pulsatility index (PI) and fetal heart rate (FHR) were derived from these recordings. Maternal blood pressure decreased significantly after both drugs. Maternal pulse rate increased after hydralazine but did not change significantly after labetalol. FHR did not change significantly after hydralazine but decreased after labetalol. PI decreased after hydralazine and increased after labetalol--most fetuses showed little change but a few in each group showed large changes in PI, as did two of five additional patients studied. We attributed the decrease in PI in some fetuses after hydralazine to vasodilation, and the increase in PI in some fetuses after labetalol to vasoconstriction in the fetoplacental circulation, suggesting that fetal beta-blockade may occur after maternal treatment with labetalol.

Adult↗

[Amoxicillin in the treatment of asymptomatic bacteriuria in pregnancy--3g single dose versus 3 times 750mg 4-day therapy].

A prospective, randomized, controlled comparative clinical trial was conducted to assess the efficacy and tolerability of 2 regimens of amoxicillin. In group A a single dose of 3 g amoxicillin and in group B a 4-day course of 3 doses of 750 mg amoxicillin tablets were administered 8-hourly. Significant bacteriuria (greater than or equal to 10(5) cfu/ml midstream urine) and of urine samples obtained by bladder catheterization (greater than or equal to 10(4) cfu/ml) was diagnosed with the dip-slide method (Uricult). 91 pregnant women with a mean gestational age of 25 weeks (14-38) were randomly allocated to both treatment groups. Group A consisted of 53 patients, group B of 38. The treatment groups were comparable in terms of age, duration of pregnancy and additional therapy. Control examinations of urine cultures were taken after 1 and 4 weeks following therapy. The predominant bacterial species was E. coli isolated in 60 to 65 percent. Bacteriological cure rates at 1 and 4 weeks were in group A 77% and 74% and in group B 62% each respectively. The differences in cure rates were not significant. Side effects occurred in group A in 4% and in group B in 13%. Our results suggest that for the treatment of asymptomatic bacteriuria in pregnancy a single dose of 3 g of amoxicillin is equally effective and acceptable as a 4-day course with the advantage of a lower total-dose, lower costs and a better compliance.

Adolescent↗

The effect of digoxin on the response to lithium therapy in mania.

Patients suffering from manic-depressive psychosis, manic type (ICD 296.0), were treated with lithium carbonate and randomly allocated to two groups, one received digoxin and the other matching placebo for 7 days. Severity of mania was rated by psychiatrists on the Manic Rating Scale and Analogue Line on days 0 and 7 and by nurses daily on the Hargreaves Rating Scale, Psychotic Rating. Fourteen patients received digoxin and lithium carbonate and 14 patients received placebo and lithium carbonate. Improvement in the placebo lithium group was significantly greater than that in the digoxin lithium group. This trial suggests, therefore, that the effect of inhibition of membrane cation carrier is to reduce the response to lithium. This result is in keeping with our hypothesis that an increase in Na-K ATPase is essential to the therapeutic effect of lithium carbonate. It does not, however, exclude the possibility that the observations resulted from the inhibition by digoxin of lithium entry into the brain.

Adult↗

Comparison of ketotifen and DSCG in treatment of food allergy in children.

The authors treated 17 food allergic, 2-14 year old children with chemoprophylactic drugs. The patients got either ketotifen or DSCG in random allocated for 4 weeks and thereafter a washout period of 2 weeks separated the trial period of the other drug. Oral challenge with the food was performed before the trial period and after a 4 week lasting elimination diet on the last day of each treatment. After the ketotifen therapy in 10 of the 17 patients no symptoms appeared after the challenge, whereas only 5 patients were completely protected by DSCG. However, with regards to isolated organ symptoms the two drugs were of equal value. In case of failure of one drug the other was effective with two exceptions. Symptoms of intolerance (vomiting, angioedema or abdominal cramps) occurred in 3 patients during DSCG treatment and in one of those getting ketotifen. In 3 cases of severe milk allergy (Heiner-Holland syndrome) symptom-free state could be attained only if diet was supplemented by ketotifen. Symptoms of food allergy can be well prevented in children through ketotifen therapy more than by DSCG.

Child↗

Efficacy of eyepad in corneal healing after corneal foreign body removal.

30 patients with corneal epithelial defect due to removal of corneal foreign bodies were randomly allocated to receive either chloramphenicol with continuous application of an eyepad or chloramphenicol without the eyepad. Almost all corneal defects were healed at 24 h, and all were healed by 48 h, with no statistically significant difference between the two groups. Discomfort at 24 h was greater in the eyepad group than in the control group. An eyepad seems to confer no benefit in healing and is uncomfortable.

Bandages↗

Randomized trial of fibrin adhesive for reduction of drained secretion after elective cholecystectomy.

Eighty patients scheduled for elective cholecystectomy were randomly allocated to application of fibrin adhesive (Beriplast) to the gallbladder bed or to a control group. No significant difference was found between the two groups in regard to amount of postoperatively drained secretion or in drainage time. Fibrin adhesive thus had no effect on secretion of peritoneal fluid after simple cholecystectomy.

Adult↗

Citalopram: clinical effect profile in comparison with clomipramine. A controlled multicenter study. Danish University Antidepressant Group.

The selective serotonin reuptake inhibitor citalopram was compared with clomipramine in a multicenter clinical study. From a total of 150 depressed patients (age 18-65 years), 114 patients with a Hamilton Depression Scale (HDS) total score greater than or equal to 18 at the end of a 1 week placebo period were started on treatment with either citalopram (40 mg/day) or clomipramine (150 mg/day) (fixed, single daily dose). Patients stratified according to diagnostic rating (Newcastle Inventory, endogenous/non-endogenous) were randomly allocated to treatment groups using double blind principles. In total, 102 patients completed more than 2 weeks, treatment and were included in the analyses of therapeutic effect. The two drug groups were comparable in terms of sex, age, and departmental distribution. Categorical measurements of therapeutic effect based on the HDS total score showed that in the endogenously depressed patients a significantly higher percentage of patients on clomipramine (n = 37) than on citalopram (n = 38) were classified as complete responders (HDS total less than or equal to 7) after 3, 4 and 5 weeks of treatment. In the non-endogenously depressed patients (clomipramine: n = 15, citalopram: n = 12) rather similar numerical differences were observed (P less than 0.05 at 5th week). In the total patient group the percentage of complete response after 5 weeks was about 60 in the clomipramine group (n = 52) and about 30 in the citalopram group (n = 50) (P less than 0.005).(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

Effects of maternal diet during late pregnancy and lactation on the development of atopic diseases in infants up to 18 months of age--in-vivo results.

One hundred and sixty-two women with respiratory allergy to animal danders and/or pollens were randomly allocated to a diet consisting of either a very low ingestion of hens' egg and cows' milk or a daily ingestion of one hens' egg and about 11 of cows' milk during the last 3 months of pregnancy. One hundred and sixty-three infants were followed prospectively up to 18 months of age when the cumulated incidence of atopic disease in each child was evaluated blindly. No significant differences in the distribution of atopic disease were found among the infants in relation to the maternal diet during late pregnancy. The numbers of skin-prick tests positive to ovalbumin, ovomucoid, beta-lactoglobulin and cows' milk were likewise not influenced by differences in the maternal diet during late pregnancy. Genetic factors rather than maternal diet during the perinatal period probably have a greater effect on the incidence of atopic diseases during early infancy.

Adult↗

Short-term treatment of vaginal candidiasis with fenticonazole ovules: a three-dose schedule comparative trial.

In an unblinded, randomized parallel group trial three different therapeutic dose schedules of fenticonazole (vaginal ovules) were compared in the treatment of vaginal candidiasis. A total of 60 patients, aged 17-71 years, affected by mycologically confirmed symptomatic vaginal candidiasis were included and randomly allocated to three treatment groups: 200 mg daily, for 3 days; 600 mg in a single administration; and 1000 mg in a single administration. Therapeutic efficacy was assessed by microbiological and clinical criteria 7 days after the end of the treatment. All mycologically cured patients were re-checked, microbiologically and clinically, 2 weeks after the end of treatment to identify and evaluate possible relapses. The results obtained indicate that vaginal application of fenticonazole ovules is highly effective in producing both symptomatic relief and mycological sterilization of vaginal swabs in 75-85% of treated patients. No relapses were noted at the time of re-check. The three administration schedules tested appear to be equally effective and well tolerated. In one case only of the group given 200 mg and two cases of those given 1000 mg, a local burning sensation was noted. These results show that short-term treatment of vaginal candidiasis with fenticonazole ovules is effective and well tolerated.

Adolescent↗

Comparison of four continuously administered progestogen plus oestradiol combinations for climacteric complaints.

Sixty women with climacteric complaints who had not menstruated for at least 1 year were randomly allocated to receive one of four hormonal replacement regimens. All four formulations were administered daily and continuously and each contained 2 mg of micronized oestradiol-17 beta in combination with either norethisterone acetate 1 mg (group A) or 0.5 mg (group B) or megestrol acetate 5 mg (group C) or 2.5 mg (group D). The clinical efficacy was the same although the alleviation of vasomotor symptoms was somewhat slower in those women receiving preparation A. The endometrium was atrophied in nearly all biopsies. Irregular uterine bleeding was almost entirely confined to the earlier phase of the study and was substantially less with the formulation containing 1 mg norethisterone acetate. It is concluded that a continuous oestradiol-progestogen combination can be used for long-term treatment of climacteric complaints in postmenopausal women and that after 4 months the clinical efficacy is the same irrespective of the type and dose of progestogen administered.

Adult↗

Auto-traction for treatment of lumbago-sciatica. A multicentre controlled investigation.

In this controlled prospective study of the Auto-traction method for the treatment of lumbago-sciatica, 82 patients were randomly allocated to either treatment with Auto-traction for up to three 1-hour sessions in 1 week, or they were given a corset and advised to rest. The orthopaedic surgeons participating in the study worked at six different hospitals and all had limited experience of the Auto-traction method obtained during a 1-week course. All patients were clinically evaluated by an independent observer who also performed the follow-up examinations 1 and 3 weeks after the treatment sessions. In addition a 3-month follow-up was performed by letter. The Auto-traction method gave prompt relief of pain and a normalizing of the SLR test more often than treatment with only a corset and rest. The difference between the two treatment groups was statistically significant. The immediate difference noted between the treatment groups had decreased slightly at 3 weeks but was still statistically significant at this time.

Back Pain↗

Salbutamol: tablets, inhalational powder, or nebuliser?

A study was carried out to ascertain the most effective method of giving salbutamol. Seventeen children with severe asthma received active salbutamol (4 mg via a nebuliser, 400 micrograms as an inhalational powder, or a 4 mg tablet) together with complementary placebos on a double-blind, triple-dummy randomly allocated basis. The bronchodilatation effect was assessed by measuring the peak expiratory flow rate. The bronchodilatation effect was greatest when patients received nebulised salbutamol (p less than 0.05) but lasted longest when they received the tablet (p less than 0.0001); the onset of the effect was rapid with all forms of administration. These results indicate that nebulised salbutamol gives the best relief in severe asthma; in less severe cases, however, a regimen combining the inhalational powder and tablets is sufficient and more convenient.

Aerosols↗