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Results for “Randomized Controlled Trial”

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At least 127 records · Page 7Linked to original sources
PubMed1984

S-adenosyl-L-methionine antagonizes oral contraceptive-induced bile cholesterol supersaturation in healthy women: preliminary report of a controlled randomized trial.

Recent experimental investigations have shown that S-adenosyl-L-methionine (SAMe) reverses estrogen-induced bile secretion impairment. The mechanism of this action seems to be related to the capability of SAMe both to inactivate catecholestrogens by methylation reaction and to methylate membrane phospholipids increasing the liver plasma membrane fluidity reduced by the estrogens. Aim of this investigation was to know whether SAMe also prevents oral contraceptive-induced cholesterol supersaturation of gallbladder bile in humans. To six healthy nonobese women whose bile cholesterol saturation index increased from a mean basal value of 0.77 (SD 0.22) to 1.20 (SD 0.38) (p less than 0.01) after two cycles of treatment with oral contraceptives containing 50 micrograms ethynylestradiol, plus 250 micrograms d-norgestrel, 200 mg SAMe per os tid was administered in addition to the oral contraceptive for other two cycles. The bile cholesterol saturation index decreased to 0.88 (SD 0.26) (p less than 0.05 versus oral contraceptive value). These results indicate that SAMe antagonizes biliary lipid changes induced by estrogen-progestin containing oral contraceptive and suggest its potential usefulness in women on oral contraceptive treatment to prevent lithogenic bile secretion.

Adult↗
PubMed1990

A randomized controlled trial of extra-amniotic ethinyloestradiol for cervical ripening in multiparas.

A double-blind randomized controlled trial was carried out to determine if ethinyloestradiol applied extra-amniotically would ripen the unfavourable cervix at term. Twenty five multiparas were given 150 mg ethinyloestradiol gel while 25 multiparas were given gel alone. There was no difference between the ethinyloestradiol and control groups in either mean change of Bishop score or the induction-to-delivery interval.

Adult↗
PubMed1979

A randomized controlled trial of geriatric screening and surveillance in general practice.

A randomized controlled trial of geriatric screening and surveillance was undertaken on a practice population of 295 patients aged 70 years or more over a two-year period. In the screened group (145 patients) many social problems were found and a total of 380 medical conditions were reported during the study period, 144 (38 per cent) of which were previously undetected. Conditions found most frequently involved the circulatory, musculoskeletal and nervous systems; 67 per cent of the conditions found were manageable, half being improved and the remainder resolved completely.The screening programme was found to increase the use of social and health services but it did also decrease the expected duration of stay in hospital.Independent assessment of patients in the study and control groups at the end of the two-year period showed that the screening programme had made no significant impact on the prevalence of socio-economic, functional, and medical disorders affecting health.We formed the firm impression that the study patients were made more comfortable (by control of pain) and less disabled, although there was no unequivocal objective evidence of this. They were, however, kept independent for longer.The findings are discussed and a model of geriatric care is suggested combining conventional management on demand with comprehensive screening to identify the high-risk patients on whom care might need to be focussed.

Aged↗
PubMed1995

Effects of "group detailing" on the prescribing of lipid-lowering drugs: a randomized controlled trial in Swedish primary care.

The objective was to study the effect of "academic group detailing" on the prescribing of lipid-lowering drugs in Swedish primary care. A randomized controlled trial was conducted, randomization being by group. Groups of doctors at 134 community health centres were randomly allocated to an intervention and a control group. The 67 intervention health centres were offered four sessions, conducted by a pharmacist, with group information on guidelines for the management of hyperlipidaemia. The number of prescriptions of lipid-lowering drugs per month increased in the intervention health centres and the increase was statistically different from the corresponding change in the control health centres among women in the age group 30-65 years (p = 0.03). The prescription of first-line lipid-lowering drugs increased by 20% in the intervention health centres (p = 0.03). "Academic group detailing" by pharmacists to primary care doctors can be an effective method for influencing prescribing practices.

Adult↗
PubMed1986

The use of a birthroom: a randomized controlled trial comparing delivery with that in the labour ward.

A randomized controlled trial of two environments for delivery was conducted at Queen Charlotte's Maternity Hospital. A total of 253 parous women expecting to have a labour ward delivery were invited to participate in the trial but only 148 agreed. These women were randomly allocated to be delivered either with standard labour ward management (n = 72) or in the birthroom--a small bedroom decorated in a homely manner, without facilities for epidural analgesia or electronic fetal monitoring (n = 76). Eleven women in the birthroom group and 10 in the labour ward group withdrew from the trial before labour and four were transferred from the birthroom to the labour ward when in labour. A questionnaire sent in the postnatal period to the women who completed the trial was returned by 80%. In the birthroom group there was significantly (i) decreased admission-to-delivery interval (ii) less analgesia (iii) more freedom of movement (iv) less suturing (v) increased rooming-in. No difference was found in the assessment of difficulty of labour nor in the method of subsequent infant feeding.

Clinical Trials as Topic↗
PubMed1986

Cefuroxime versus ampicillin plus chloramphenicol in childhood bacterial meningitis: a multicenter randomized controlled trial.

In a multicenter randomized trial, 107 children with bacterial meningitis were initially given either cefuroxime or ampicillin plus chloramphenicol. Patients were alternately assigned to 7- or 10-day courses of the designated antimicrobial regimen. CSF isolates included Haemophilus influenzae type b (89, of which 25% were beta-lactamase positive), Streptococcus pneumoniae, and Neisseria meningitidis. Although mean CSF bactericidal titers against Haemophilus isolates were 1:6 in each treatment group, H. influenzae was cultured from CSF in four of 39 patients receiving cefuroxime, 24 to 48 hours after initiation of therapy, compared with none of 40 patients given ampicillin plus chloramphenicol (P = 0.11). Clinical cure rates were similar (95%); one death occurred in each group. One child given cefuroxime had persistent meningitis after 5 days of therapy, and mastoiditis with secondary bacteremia developed in one on day 10. Three patients had relapse or reinfection. One patient who received cefuroxime for 10 days had a relapse of epiglottitis 17 days later, and of the patients given ampicillin plus chloramphenicol, one had a relapse of meningitis 1 week after 7 days of therapy, and bacteremia developed in one 42 days after completion of 10 days of therapy. No increase in either in-hospital complications or relapses occurred with a 7-day treatment course. Proof of the equivalence of the antibiotic regimens and the efficacy of 7-day courses of treatment, as well as the consequences of delayed CSF sterilization, will require additional investigation.

Adolescent↗
PubMed1995

The feasibility of a control population for a randomized control trial of seizure prophylaxis in the hypertensive disorders of pregnancy.

OBJECTIVE: To document the feasibility of a control population for a randomized controlled trial, we report our experience in managing hypertensive pregnancies without seizure prophylaxis. STUDY DESIGN: An 8-year cross-sectional study in one institution was performed of all hypertensive patients. RESULTS: Of 467 patients with preeclampsia or superimposed preeclampsia managed without seizure prophylaxis, 18 had seizure activity, 3.9% (95% confidence interval 2.3% to 6.0%). There was no seizure-related maternal mortality or major morbidity, and the perinatal mortality rate after 28 gestational weeks was the same in patients with or without seizures. By logistic regression seizures were 17.4 times more likely in preeclampsia and 8.1 times more likely in chronic hypertension with superimposed preeclampsia, compared with gestational or chronic hypertension alone. CONCLUSION: The rate of seizures in patients with preeclampsia or superimposed preeclampsia managed without seizure prophylaxis was low and unassociated with an increase in maternal or perinatal mortality. A control arm is feasible in a randomized, controlled trial to address the issue of whether antiseizure medication can prevent eclampsia.

Anticonvulsants↗
PubMed1992

[Reappraisal of Zelen's method in randomized controlled trials].

This paper discusses Zelen's method (a study design with pre-randomization) in randomized controlled trials from the following aspects: 1) compliance of patients with a randomly assigned treatment; 2) infringement of patients' right to choose treatments; and 3) unfairness that only patients assigned to a new treatment are allowed a choice of treatments. The reason Zelen's method is rarely used in the United States or European countries seems to be the lower compliance of treatments in Zelen's method than in the conventional design of randomized controlled trials. Considering the present study practice in Japan, where study subjects are not completely informed by randomized assignment of treatments, Zelen's method is thought to be more practical, and not inferior to the conventional design in terms of compliance.

Humans↗
PubMed2026

Impact of kangaroo care on circadian rhythm, growth, physiological stability in premature infants, and cortisol and melatonin levels in maternal breast milk: A randomized controlled trial.

PURPOSE: This study aimed to examine the effects of regular kangaroo care (KC) on sleep-wake cycles, growth, physiological stability, and maternal breast milk cortisol and melatonin levels in premature infants. DESIGN: This study was a parallel group, single-blind, pre-test-post-test, randomised controlled trial (RCT). METHODS: This randomized controlled study was conducted in a neonatal intensive care unit (NICU) in T&#xfc;rkiye between September 2024 and September 2025 Thirty-six premature infants were randomized to intervention (n = 28) or control (n = 28). Infants in the intervention group received KC for three consecutive days, twice daily (10:00 a.m. and 10:00 p.m.) for 60 min per session. Data were collected using the Infant Information Form, Physiological Parameters Monitoring Chart, and Premature Infant Sleep-Wake Cycles Tracking Chart. Sleep-wake cycles were monitored using a Bispectral Index device. Breast milk cortisol and melatonin levels were measured at baseline and on day three using the competitive ELISA method. The study was registered at ClinicalTrials.gov (NCT06589349). RESULTS: Regular KC had a statistically significant effect on BIS values, heart rate, respiratory rate, oxygen saturation, and body temperature (p < 0.05). No statistically significant effects were observed on infant body weight or on maternal breast milk cortisol and melatonin levels (p > 0.05). CONCLUSION: The findings indicate that regular KC is associated with improved regulation of the sleep-wake cycle and enhanced physiological stability in premature infants. No significant changes were observed in maternal breast milk cortisol or melatonin levels following KC.

Humans↗
PubMed1980

A randomized controlled trial of prenatal nutritional supplementation in New York City.

This randomized controlled trial of nutritional supplementation in pregnancy, in a poor black urban population in the United States, aimed to increase the birth weight and influence the postnatal development of the offspring of mothers at high risk of having low birth weight infants. The execution of the research design and adherence to the treatment regimen among the experimental population appeared adequate for a reasonable test of the treatments. At birth, the only significant favorable effect of supplementation observed was the prevention of depressed birth weight among the offspring of mothers who smoked heavily. With balanced protein-calorie supplementation, length of gestation was increased, the proportion of low-birth-weight infants reduced, and mean birth weight raised by 41 gm (not statistically significant). With high protein supplementation, there was an excess of very early premature births and associated neonatal deaths, and there was significant growth retardation up to 37 weeks of gestation. At 1 year of age, significant effects of high protein supplement were found on three psychological measures: visual habituation, visual dishabituation, and mean length of free play episodes. These measures were unrelated to measures of growth at birth and at 1 year of age. There were no detectable residual adverse effects of high protein supplementation at 1 year of age.

Birth Weight↗
PubMed1984

Fast neutrons in the treatment of head and neck cancers: the results of a multi-centre randomly controlled trial.

The results are presented of a multi-centre randomly controlled trial of fast neutron irradiation and mega-voltage X-rays in the treatment of patients with locally advanced squamous cell carcinoma of the head and neck region. No significant difference was observed in local tumour control rates. Salvage surgery was performed in a similar number of patients in the two groups. Late morbidity was also similar in the two treatment groups. Patients in a subgroup with cancer of the larynx treated by photons had a significantly better survival than those in the neutron treated group.

Aged↗
PubMed1977

Randomized controlled trial of early discharge for inguinal hernia and varicose veins.

A randomized controlled trial has been conducted into the effects of discharging patients from hospital either at 48 h or 6-7 days after operation for inguinal hernia or varicose veins. There was no statistically significant difference in the frequency of major postoperative complications between the two lengths of stay for either of the conditions studied. Similarly there was no difference between the two groups of hernia patients in relation to eventual recurrences.

Clinical Trials as Topic↗
PubMed1987

Successful management of daytime enuresis using alarm procedures: a randomly controlled trial.

Forty four children with daytime wetting were included in a randomly controlled trial of two alarm devices, a contingent one that sounded when wetting occurred and a non-contingent one that went off from time to time unrelated to wetting events. A quota allocation system ensured comparability between treatment groups. Two thirds responded to an alarm by becoming dry. The non-contingent alarm produced as good a response as the contingent one and is recommended for routine use in children with diurnal enuresis. Twenty three per cent of those who responded to treatment relapsed up to two years after completion of the trial.

Adolescent↗
PubMed1990

How best to teach women breast self-examination. A randomized controlled trial.

OBJECTIVE: To compare three methods for teaching breast self-examination. DESIGN: Randomized controlled trial with factorial design. SETTING: A general medicine group practice in a university hospital. PATIENTS: Continuing-care patients from 40 to 68 years of age. Of 456 eligible women, 156 refused participation, 300 were randomly assigned, 269 completed assigned interventions, and 260 completed the post-test 1 year later. INTERVENTIONS: One third of patients received nurse instruction stressing tactile skills (Mammacare group) (Mammatech Corporation, Gainesville, Florida); one third, traditional nurse instruction emphasizing technique (traditional group); and one third, no nurse instruction (control group). Half of each group received physician encouragement. MEASUREMENTS AND MAIN RESULTS: One year later, women in the Mammacare group found more lumps (mean, 57%; 95% CI, 54% to 60%) in manufactured breast models than did those in the traditional (mean, 47%; CI, 44% to 51%) and control (mean, 45%; CI, 42% to 48%) groups. Lump detection specificity was unaffected. Self-reported examination frequency rose in all groups, to 5.1 times per 6 months in the traditional group, 4.2 in the Mammacare group, and 3.9 in the control group. Physician encouragement did not improve sensitivity, specificity, or overall frequency. Women in the Mammacare group used more of seven examination techniques (4.9) than did those in the traditional (3.9) or control (3.2) groups (P less than 0.001). No group increased health care use or reported more overall worry about breast cancer. CONCLUSIONS: Mammacare instruction resulted in more long-term improved lump detection and examination technique use than did traditional instruction or physician encouragement. Breast self-examination instruction should emphasize lump detection skills.

Adult↗
PubMed1992

A randomized controlled trial of early surgery in Duchenne muscular dystrophy.

We performed a randomized controlled trial of early surgical treatment of contractures in 20 boys with Duchenne muscular dystrophy, age 4-6 yr. Surgery consisted of release of hip flexors, removal of iliotibial bands, and lengthening of tendo Achilles bilaterally. All patients were monitored for at least 12 months post-randomization, and assessed quantitatively for muscle strength and function. Surgery corrected the deformities, but had no beneficial effect on strength or function. Indeed, data in the second year showed more rapid deterioration of function in some of the operated boys. There appeared to be continued evolution of pathology following surgery, as assessed by sequential muscle ultrasound and muscle biopsy. We cannot recommend this type of surgery as a routine treatment.

Biopsy↗
PubMed1988

Effects of transdermal clonidine treatment on withdrawal symptoms associated with smoking cessation. A randomized, controlled trial.

In a double-blind, randomized, placebo-controlled trial, we studied 40 cigarette smokers to determine the effects of one week of transdermal clonidine hydrochloride (Catapres-TTS No. 2) treatment on the withdrawal symptoms associated with smoking cessation. Subjects were instructed to maintain their usual cigarette intake during days 1 through 3 and cease smoking for days 4 through 6. All of the withdrawal symptoms measured (craving, irritability, anxiety, restlessness, difficulty concentrating, and hunger) significantly increased during the three days of smoking cessation in the placebo group. There was a 4.3-fold increase in craving, a 3.8-fold increase in irritability, a 3.7-fold increase in anxiety, and a 3.3-fold increase in restlessness in the placebo group compared with the transdermal clonidine group during the three days of smoking cessation. Impairment of concentration and hunger were not significantly diminished by transdermal clonidine treatment during smoking cessation. In addition, a trend was present in the transdermal clonidine group to spontaneously decrease the number of cigarettes smoked per day during the smoking period. Side effects were generally mild. We conclude that transdermal clonidine treatment ameliorates some of the short-term withdrawal symptoms, especially craving, associated with smoking cessation.

Acute Disease↗
PubMed1985

A randomized controlled trial of prophylactic cytotoxic chemotherapy in potentially curable breast cancer.

A randomized controlled trial of the value of oral adjuvant cytotoxic chemotherapy in the treatment of potentially curable breast cancer has been in progress in the Oxford Region since 1977. Eighty-seven patients were allocated to treatment with melphalan 0.2 mg/kg for 5 consecutive days every 6 weeks for 2 years; 98 patients were allocated to treatment with oral combination therapy consisting of melphalan 10 mg daily for 5 consecutive days, plus methotrexate 15 mg and 5-fluorouracil 250 mg on the first day, courses being repeated every 6 weeks for 2 years; and 88 patients were allocated to a control group which received no adjuvant chemotherapy. So far, 125 patients have suffered a recurrence of breast cancer and 85 have died. No statistically significant differences in outcome are apparent between the three treatment groups, although there is some indication of a beneficial effect of chemotherapy on disease-free interval in pre-menopausal women. Toxic effects of treatment, notably nausea, vomiting and bone marrow depression, have been moderately severe. In our view, the beneficial effects of current adjuvant cytotoxic chemotherapy, if any, are too modest to justify the suffering which such treatment can cause at a time when a woman with breast cancer might otherwise expect to feel physically well.

Adult↗