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Results for “randomized crossover trial”

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At least 811 records · Page 45Linked to original sources

PubMed1991

Effect of food on bioavailability of pseudoephedrine and brompheniramine administered from a gastrointestinal therapeutic system.

The purpose of this study was to determine how a high-fat meal affects the delivery and absorption of pseudoephedrine and brompheniramine maleate when delivered from a gastrointestinal therapeutic system (GITS). This study was a randomized, complete crossover trial with 12 healthy male volunteers who were given single doses of the 24-h GITS under fed and fasted conditions. Pharmacokinetic parameters for both drugs were comparable between fed and fasted treatments, except for a shorter time to maximum concentration of pseudoephedrine for fed subjects (p = 0.002). Bioavailability of pseudoephedrine was 91% for fed relative to fasted treatment; for brompheniramine it was 89%. These results indicate that codelivery of the two drugs from the GITS is reliable and prolonged, and that the resulting absorption of pseudoephedrine and brompheniramine is minimally affected by food.

Adult↗

PubMed1990

Effects of physical training in chronic heart failure.

Eleven patients with chronic heart failure secondary to ischaemic heart disease (mean [SEM] age 63.0 [2.3] years; left ventricular ejection fraction 19 [8]% undertook 8 weeks of home-based bicycle exercise training and 8 weeks of activity restriction (rest) in a physician-blind, random-order, crossover trial. Training increased exercise duration from 14.2 (1.1) min to 16.8 (1.3) min and peak oxygen consumption from 14.3 (1.1) ml.min-1.kg-1 to 16.7 (1.3) ml.min-1.kg-1. Heart rates at submaximum workloads and rate-pressure products were significantly reduced by training, and there was also a significant improvement in patient-rated symptom scores. No adverse events occurred during the training phase. Thus home-based physical training programmes are feasible even in severe chronic heart failure and have a beneficial effect on exercise tolerance, peak oxygen consumption, and symptoms. The commonly held belief that rest is the mainstay of treatment of chronic heart failure should no longer be accepted.

Aged↗

PubMed1985

THC or Compazine for the cancer chemotherapy patient--the UCLA study. Part II: Patient drug preference.

Factors influencing preference for THC vs. Compazine (prochlorperazine) as an antiemetic agent during cancer chemotherapy were studied in 139 patients who received both medications in a double-blind randomized crossover design trial. Nausea reduction was the main determinant of preference. THC preference was associated with more, rather than fewer, drug-related side effects than Compazine, particularly sedation. Patients who reported being anxious or depressed did not experience accentuation of their mood states with either regime. Mood effects, nausea reduction, incidence of side effects, and drug preference were the same in patients under and over 50 years of age. Patients with a history of illicit drug use reported fewer side effects from THC, but reported no difference in drug preference or nausea reduction compared to those patients without a history of illicit use.

Adolescent↗

PubMed1999

The Pacing Therapies for Congestive Heart Failure (PATH-CHF) study: rationale, design, and endpoints of a prospective randomized multicenter study.

In conjunction with pharmacologic therapy, pacing has been proposed as a potential treatment to decrease symptoms in patients with moderate-to-severe congestive heart failure (CHF). Uncontrolled studies of pacing therapy for CHF dealing with different pacing sites, modes of pacing, and atrioventricular delays have reported mixed outcomes. The Pacing Therapies in Congestive Heart Failure (PATH-CHF) study is a single-blind, randomized, crossover, controlled trial designed to evaluate the effects of pacing on acute hemodynamic function and to assess chronic clinical benefit in patients with moderate-to-severe CHF. The effect of pacing on oxygen consumption at peak exercise and at anaerobic threshold during cardiopulmonary exercise tests, and on 6-minute walk distance, have been selected as primary endpoints of the study. Secondary endpoints of the trial were changes in New York Heart Association (NYHA) functional class, quality-of-life as assessed by the Minnesota Living with Heart Failure questionnaire, and hospitalization frequency. Finally, changes in ejection fraction, cardiac output, and filling pattern were assessed by echocardiography. The trial was planned to include 53 patients from 7 centers in Europe over a period of 3 years. The study was divided into 2 parts: acute testing and chronic follow-up. The acute study, performed during the pacemaker implantation, involved extensive testing using a custom-designed computer (FLEXSTIM) and a unique burst pacing protocol (FLEXSTIM protocol) to determine the best ventricular pacing sites and the most appropriate atrioventricular delays. The chronic phase consisted of a crossover study designed to test in each patient the best univentricular pacing site and biventricular pacing as assessed by the acute hemodynamic study. The study started with the first implant in 1995 and has, to date, included 42 patients. The study is expected to be completed by the end of 1998. The results of a first interim analysis showed trends toward improvement in all primary and secondary endpoints during the pacing periods compared with no pacing.

Adult↗

PubMed1993

Bioavailability, pharmacokinetics, and pharmacodynamics of torsemide in patients with cirrhosis.

The bioavailability, pharmacokinetics, and pharmacodynamics of torsemide (10 mg orally and intravenously) were determined in a randomized crossover clinical trial with 12 patients with ascites caused by cirrhosis. Torsemide was rapidly absorbed with a bioavailability of 96.3% (confidence interval, 84% to 109%). Compared with healthy subjects, patients with cirrhosis exhibit a decrease in nonrenal clearance and increases in bioavailability, volume of distribution, renal clearance, elimination half-life, and percentage of the dose excreted into the urine. A greater proportion of the dose is delivered to the site of action over a more prolonged period of time. In spite of a shift of the pharmacodynamic curve to the right in patients with cirrhosis, there was no significant difference in natriuresis. Pharmacokinetic changes of torsemide in cirrhosis therefore compensate for the pharmacodynamic abnormality.

Administration, Oral↗

PubMed1986

Comparison of two chamber devices in patients using a metered-dose inhaler with satisfactory technique.

A randomized clinical crossover trial was carried out to compare the use in the home, during 1-week periods, of two commercially available chamber devices (the Aerochamber and the Spacer) and a standard metered-dose inhaler (MDI) in 24 patients with reversible bronchospasm and satisfactory inhaler technique. Measurements of peak flow, forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), ratio of FEV1 to FVC and forced midexpiratory flow rate were made immediately before and 15 minutes after inhalation of terbutaline sulfate. No difference was noted in results of spirometry, peak flow readings or side effects between the devices. The results of spirometry were better during the trial than immediately before it (p less than 0.01). The mean score for inhaler technique was significantly lower at follow-up than during the trial (p less than 0.001). The results suggest that in this population there is no advantage to using either a chamber device rather than an MDI or one chamber device rather than the other.

Asthma↗

PubMed2001

Assessment of posterior cricoarytenoid botulinum toxin injections in patients with abductor spasmodic dysphonia.

In this study, we compared 2 techniques for injection of botulinum toxin type A (Botox) into the posterior cricoarytenoid (PCA) muscle for the treatment of abductor spasmodic dysphonia (ABSD). Fifteen patients with ABSD were enrolled in a prospective randomized crossover treatment trial comparing the 2 injection techniques. The PCA muscle was injected with 5 units on each side, with the injections staged 2 weeks apart, via either a percutaneous posterior-lateral approach or a transnasal fiberoptic approach. Eleven patients reported some benefit with the injections; however, the patient-perceived benefits were not related to changes in symptoms on blinded counts by speech pathologists. No significant reductions in the numbers of breathy breaks occurred with either technique, and no differences were found between techniques. Although patients perceived a benefit, blinded symptom counts did not substantiate these benefits. Thus, PCA muscle injections of Botox provided limited benefits to patients with ABSD, demonstrating the need for a more effective therapy for these patients.

Adult↗

PubMed1986

Effect of regular alcohol use on blood pressure control in treated hypertensive subjects: a controlled study.

Forty-four males with treated essential hypertension and a moderate-to-heavy alcohol intake participated in a randomized controlled crossover trial of the effects of varying alcohol intake on blood pressure control. Usual antihypertensive therapy was maintained unchanged throughout. Self-reported alcohol consumption fell from 452 ml ethanol/week (s.e.m. = 29) during normal drinking habits to 64 ml/week (s.e.m. = 8) while drinking low alcohol content beer. Mean systolic and diastolic blood pressures were significantly lower during the last 2 weeks of reduced alcohol (supine 5.0 mmHg, s.e.m. = 1.4, and 3.0 mmHg, s.e.m. = 0.9, respectively; erect 5.9 mmHg, s.e.m. = 1.6, and 2.9 mmHg, s.e.m. = 1.0, respectively). Body weight was also lower (0.94 kg, s.e.m. = 0.25) at the conclusion of the low alcohol intake period. Regression analysis suggested that reduction in alcohol intake contributed independently to the fall in both systolic and diastolic blood pressure, while weight change contributed independently to the fall in systolic blood pressure alone. It was concluded that curtailing moderate to heavy alcohol intake leads to improved blood pressure control in treated essential hypertensive males.

Adult↗

PubMed2000

A randomized crossover evaluation of antianginal efficacy and safety of nitrolingual-spray and nitroglycerin tablet form in coronary artery disease patients.

Twenty-eight coronary artery disease patients with more than 50% stenosis in at least one major coronary artery completed this randomized crossover clinical trial for the comparison of efficacy and safety of Nitrolingual-Spray and nitroglycerin (NTG) tablets. Exercise time was lengthened to 399.1 s (spray) or 408.5 s (tablets), compared to a baseline of 387.3 s. Ischemic burden decreased to about -4.0 mm with both forms, compared to -7.5 mm at baseline (ANOVA: p = 0.003). The ischemic time improved to 137.2 s (spray) or 152.9 s (tablets), compared to 253.4 s at baseline (ANOVA: p = 0. 005). Patients taking tablets experienced more episodes of hypotension and/or headache compared to patients taking the spray. Nitrolingual-Spray is as effective and safe as NTG tablets for the treatment of symptomatic coronary heart disease.

Administration, Inhalation↗

PubMed2005

Functional magnetic resonance imaging of human hypothalamic responses to sweet taste and calories.

BACKGROUND: Evidence exists that beverages do not trigger appropriate anticipatory physiologic responses, such as cephalic phase insulin release. Therefore, it is of interest to elucidate the food properties necessary for triggering adaptive responses. Previously, we found a prolonged dose-dependent decrease in the hypothalamic functional magnetic resonance imaging signal after ingestion of a glucose solution. OBJECTIVES: The aims of the present study were to measure the effects of sweet taste and energy content on the hypothalamic response to glucose ingestion and to measure the concomitant changes in blood glucose and insulin concentrations. DESIGN: Five healthy, normal-weight men participated in a randomized crossover design trial. The subjects were scanned 4 times for 37 min on separate days with functional magnetic resonance imaging. After 7 min, they ingested 1 of the following 4 stimuli (300 mL of each): water (control), a glucose solution, an aspartame (sweet taste) solution, or a maltodextrin (nonsweet carbohydrate) solution. RESULTS: Glucose ingestion resulted in a prolonged and significant signal decrease in the upper hypothalamus (P < 0.05). Water, aspartame, and maltodextrin had no such effect. Glucose and maltodextrin ingestions resulted in similar increases in blood glucose and insulin concentrations. However, only glucose triggered an early rise in insulin concentrations. Aspartame did not trigger any insulin response. CONCLUSIONS: Our findings suggest that both sweet taste and energy content are required for a hypothalamic response. The combination of sweet taste and energy content could be crucial in triggering adaptive responses to sweetened beverages.

Adult↗

PubMed2003

Pharmacokinetics and tolerability of a new intravenous immunoglobulin preparation, IGIV-C, 10% (Gamunex, 10%).

BACKGROUND AND OBJECTIVES: A new intravenous immunoglobulin (IGIV) process has been developed that integrates efficient inactivation of enveloped virus, using caprylate, with immunoglobulin G (IgG) purification and caprylate removal by column chromatography. Two clinical studies were conducted to compare the pharmacokinetics of the new product, IGIV-C, 10% (Gamunex, 10%), formulated with glycine, with the licensed solvent-detergent (SD)-treated intravenous immunoglobulin IGIV-SD, 10% (Gamimune N, 10%), formulated with glycine, and IGIV-C, 5%, formulated with 10% maltose. MATERIALS AND METHODS: Both studies were randomized, multicentre crossover trials of 18 and 20 (respectively) adult patients with primary humoral immune deficiency in which patients received one IGIV product for three consecutive periods (3-4 weeks) before crossing over to the other product. Pharmacokinetic parameters were determined after the third infusion of each product. RESULTS: IGIV-C, 10% was bioequivalent to IGIV-SD, 10%, with half-lives (t1/2) of 35 and 34 days, respectively. IGIV-C, 5%, was bioequivalent to IGIV-C, 10%, with t1/2 of 35 and 36 days, respectively. The products had comparable safety profiles. CONCLUSIONS: The pharmacokinetic profiles observed in these trials indicate that IGIV-C, 10% may replace, and be administered in a manner similar to, IGIV-SD, 10%.

Adult↗

PubMed1995

Bioavailability, pharmacokinetics, and pharmacodynamics of torsemide and furosemide in patients with congestive heart failure.

The bioavailability, pharmacokinetics, and pharmacodynamics of torsemide (10 mg orally and intravenously) and furosemide (40 mg orally and 20 mg intravenously) were determined in a randomized crossover clinical trial in 16 patients with compensated congestive heart failure. Torsemide (time to reach maximum concentration [tmax], 1.1 +/- 0.9 hour) was more rapidly absorbed than furosemide (tmax, 2.4 +/- 2.5 hours), the absorption of which was delayed compared with that in healthy volunteers. Bioavailability of torsemide was also greater and less variable than that of furosemide. All four treatments yielded comparable changes from baseline in 24-hour electrolyte excretion. Based on the relationships between sodium excretion rate and fractional sodium and urinary drug excretion rate, response to both diuretic agents at the level of the nephron was decreased compared with previous studies with healthy subjects. Assessment of the clinical relevance, if any, of the difference in the variability of absorption warrants further study.

Administration, Oral↗

PubMed2004

Bioavailability of phenolic compounds from olive oil and oxidative/antioxidant status at postprandial state in healthy humans.

Olive oil phenolic compounds are generally believed to have beneficial antioxidant effects, but little is known about characteristics of their postprandial bioavailability in natural olive oil at real-life doses. The aim of the present study was to determine the concentrations of olive oil phenolic compounds in urine collected over 24 h (24-h urine) after a bolus ingestion of 25 ml of olive oil with different phenolic content, and to demonstrate the effect of this real-life olive oil dose on postprandial levels of blood lipids and oxidative stress biomarkers, as well as to examine the beneficial effects of olive oil phenols. Oral fat loads of 25 ml olive oil with high, moderate, and low phenolic content were administered to 12 healthy male volunteers in a randomized, controlled, crossover trial. Tyrosol and hydroxytyrosol were absorbed in a dose-dependent manner according to the phenolic content of the olive oil administered. The administered dose of 25 ml, which is close to that used daily in Mediterranean countries, did not induce significant postprandial lipemia nor did it promote an increase of in vivo oxidation markers. With regard to plasma antioxidant enzymes, glutathione peroxidase activity decreased postprandially after low phenolic content olive oil ingestion; however this was not observed after intake of moderate and high phenolic content olive oils. The phenolic content of the olive oils administered may account for the protection of the endogenous antioxidant defenses at postprandial state after ingestion of moderate and high phenolic content olive oils.

Adult↗

PubMed2006

Comparison of Clinpro Cario L-Pop estimates with CIA lactic acid estimates of the oral microflora.

Clinpro Cario L-Pop (CCLP) is a semiquantitive test claimed to determine the general potential for caries development and to monitor the individual caries risk. This test translates the capacity of the tongue microflora to produce lactic acid into a score of 1-9, indicating a low, medium or high risk for caries development. The aim of this randomized crossover, clinical trial was to evaluate the CCLP on its variation over time and its capacity to monitor the effect of three different oral hygiene procedures. The CCLP readings were compared with measurements of lactic acid in tongue biofilm and plaque samples by capillary ion electrophoresis (CIA). After four washout periods, the distribution of scores in the low-, medium-, and high-risk categories was 10%, 16%, and 74%, respectively. Out of 30 subjects, 11 scored consistently in the same category. The coefficients of variance of lactic acid concentrations were 31% for tongue samples and 25% for plaque samples. After using antimicrobial toothpaste and mouthwash, the number of high-risk scores was reduced to 33%; reduced acidogenicity was also found in tongue and plaque samples. We conclude that CCLP can be used to monitor and stimulate compliance to an antimicrobial oral hygiene protocol.

Adult↗

PubMed2005

Almonds in the diet simultaneously improve plasma alpha-tocopherol concentrations and reduce plasma lipids.

The objective of this study was to assess the dose-response effect of almond intake on plasma and red blood cell tocopherol concentrations in healthy adults enrolled in a randomized, crossover feeding trial. Participants were 16 healthy men and women, aged 41+/-13 years. After a 2-week run-in period, participants were fed three diets for 4 weeks each: a control diet, a low-almond diet, and a high-almond diet, in which almonds contributed 0%, 10%, and 20% of total energy, respectively. Changes in blood tocopherol levels were assayed by high pressure liquid chromatography. Incorporating almonds into the diet helped meet the revised Recommended Dietary Allowance of 15 mg/day alpha-tocopherol and increased lipid-adjusted plasma and red blood cell alpha-tocopherol concentrations. A significant dose-response effect was observed between percent energy in the diet from almonds and plasma ratio of alpha-tocopherol to total cholesterol.

Adult↗

PubMedDate not supplied

The effectiveness of chiropractic management of fibromyalgia patients: a pilot study.

OBJECTIVE: To demonstrate the effectiveness of chiropractic management for fibromyalgia patients using reported pain levels, cervical and lumbar ranges of motion, strength, flexibility, tender points, myalgic score and perceived functional ability as outcome measures. DESIGN: A. Preliminary randomized control crossover trial. B. Before and after design. PATIENTS: Twenty-one rheumatology patients (25-70 yr). CHIROPRACTIC INTERVENTIONS: Treatment consisted of 4 wk of spinal manipulation, soft tissue therapy and passive stretching at the chiropractors' discretion. CONTROL INTERVENTION: Chiropractic management withheld for 4 wk with continuation of prescribed medication. MAIN OUTCOME MEASURES: Changes in scores on the Oswestry Pain Disability Index, Neck Disability Index, Visual Analogue Scale, straight leg raise and lumbar and cervical ranges of motion were observed. RESULTS: Chiropractic management improved patients' cervical and lumbar ranges of motion, straight leg raise and reported pain levels. These changes were judged to be clinically important within the confines of our sample only. CONCLUSIONS: Further study with a sample size of 81 (for 80% power at alpha < or = .05) is recommended to determine if these findings are generalizable to the target population of fibromyalgia suffers.

Adult↗

PubMed1979

Clinical comparison of fenbufen and aspirin in osteoarthritis.

The objective of the study was to compare efficacy and safety of Fenbufen and Aspirin in osteoarthritis. The study was a double-blind, randomized trial with crossover. The test subjects were treated for 4 weeks with 600 mg Fenbufen and for 4 weeks with 3.6 g Aspirin per day. 35 patients with osteoarthritis of the knee and 18 patients with osteoarthritis of the hip participated in the study. The physical measurements of osteoarthritis activity showed significant improvement with both Fenbufen and Aspirin. The drugs were comparable with respect to: 1) improvement of physical m-easurements, 2) investigator's assessments, and 3) patients' assessments. A smaller number of patients reported drug-related side effects with Fenbufen than with Aspirin. 57% of the patients reported side effects during treatment with Aspirin and 40% during treatment with Fenbufen. There were no abnormalities discovered in haematologic or biochemical tests performed during the course of the trial.

Administration, Oral↗

PubMed2005

Lymphocyte responses to influenza and tetanus toxoid in vitro following intensive exercise and carbohydrate ingestion on consecutive days.

The effect of carbohydrate (CHO) ingestion on antigen- (rather than mitogen-) stimulated T-cell responses to prolonged, intensive exercise may give a more realistic insight into the effect of CHO on T-cell functional capacity and subsequent infection risk. This study investigated the effect of CHO ingestion during prolonged, intensive exercise on influenza- and tetanus toxoid-stimulated T-cell cytokine mRNA expression and proliferation. Mitogen- [phytohemagglutinin (PHA)] stimulated proliferation was assessed for comparison. Responses were assessed following exercise on consecutive mornings to determine any carryover effect. Fifteen male games players performed two exercise trials in a double-blind, randomized, crossover design. Each trial comprised 90 min of intensive, intermittent running on consecutive mornings, with either CHO (6.4% wt/vol) or placebo (PLA) beverage ingestion before, during, and after each bout of exercise. Postexercise CD3(+) cell counts were higher in PLA than CHO on both days (P < 0.05). Antigen-stimulated T-cell cytokine mRNA expression was unaffected by exercise or CHO ingestion. Before exercise on day 2, T-cell proliferative responses to PHA, influenza, and tetanus toxoid were higher in CHO than PLA by 99, 80, and 58%, respectively (P < 0.01 for PHA, P < 0.05 for influenza and tetanus toxoid). At 1 h postexercise on day 2, PHA-induced proliferation was 70% higher in CHO than PLA (P < 0.05), yet there were no differences between trials for antigen-induced proliferative responses. Therefore, mitogen-induced T-cell proliferation following strenuous exercise and CHO does not necessarily reflect responses to specific antigens and, consequently, may not provide a good model for the situation in vivo.

Adult↗