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Results for “randomized crossover trial”

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At least 109 records · Page 6Linked to original sources
PubMed2005

Sacral versus pudendal nerve stimulation for voiding dysfunction: a prospective, single-blinded, randomized, crossover trial.

AIMS: The objective of the study was to compare sacral nerve stimulation (SNS) to pudendal nerve stimulation (PNS) for voiding dysfunction. METHODS: Thirty subjects with voiding dysfunction had a tined lead placed at S3 and a second electrode implanted at the pudendal nerve via a posterior approach. In a blinded, randomized fashion, each lead was tested for 7 days. Voiding diaries and questionnaires were completed and outcomes monitored. RESULTS: The time to place a sacral lead was 25.85 min, pudendal lead 23.71 min (P = 0.57). Twenty-four of 30 (80%) subjects responded and had a permanent implant placed. PNS was chosen as a superior lead in 79.2%, SNS was superior in 20.8%. The order in which the lead was simulated had no impact on the final lead implanted and no carry over effect was seen. Overall reduction in symptoms was 63% for PNS and 46% for SNS (P = 0.02). On a 7-point scale from markedly worse to markedly better, the pudendal lead was superior to sacral for pelvic pain (P = 0.024), urgency (P = 0.005), frequency (P = 0.007), and bowel function (P = 0.049). Complications were minimal. CONCLUSIONS: This is the first blinded study of sacral versus pudendal stimulation for voiding dysfunction. Successful implantation of a pudendal lead was achieved in all subjects. The majority of subjects chose PNS to be superior to SNS. More patients and longer term data is needed to confirm these promising results.

Adult↗
PubMed2003

Collection of MNCs and progenitor cells by two separators for PBPC transplantation: a randomized crossover trial.

BACKGROUND: Efficient collection of progenitor cells is essential for PBPC transplantation. Two apheresis machines (Amicus, Baxter Healthcare; and Spectra, Gambro BCT, software version 4.7) were compared prospectively by a crossover trial. STUDY DESIGN AND METHODS: Apheresis collections were performed for two consecutive days on patients for autologous and donors for allogeneic PBPC transplantation. The patients and donors, receiving a G-CSF, were randomized into two groups. In Group I, PBPCs were collected by the Amicus on the 1st day and the Spectra on the 2nd day, and the reverse order was used with Group II. A total of 60 apheresis procedures of 30 (16 in Group I and 14 in Group II) among 40 patients and donors enrolled were performed and evaluated. RESULTS: The nucleated cell counts, MNC counts, CD34+ PBPC counts, and amounts of CFU-GM collected per procedure were similar with the Amicus and the Spectra. On the other hand, the decrease of peripheral blood platelet counts of patients and donors was more prominent from using Spectra than Amicus (p < 0.0001). Components collected by the Amicus had fewer platelets than those collected by the Spectra (p < 0.0001). The efficiencies of collecting nucleated cells, MNCs, and CD34+ PBPCs were not different between the machines (p > 0.05). However, the efficiency of collecting platelets was significantly higher with Spectra than with Amicus (p < 0.0001). The Amicus took longer than the Spectra to process the same volume (p < 0.05). CONCLUSION: Amicus is superior to Spectra in avoiding apheresis-induced thrombocytopenia caused by platelets contaminating the collected samples. Therefore, the Amicus is useful for patients with thrombocytopenia or with a less-than-normal platelet count.

Adolescent↗
PubMed2005

Randomized crossover trial of intravenous 5-FU versus oral UFT both modulated by leucovorin: a one-centre experience.

Although intravenous (IV) 5-fluorouracil (5-FU) and uracil/futraful (UFT) have comparable antitumour efficacy in the treatment of metastatic colorectal cancer (MCC), we wanted to assess which of these two regimens would be preferred by our patients. We randomized 20 previously untreated patients with MCC at our centre to receive oral UFT or bolus IV 5-FU both associated with leucovorin. After the first cycle patients were crossed over to the other arm. Before the third cycle we left patients to choose one of the regimens to continue their treatment until disease progression. Two patients chose 5-FU and 18 chose UFT (P < 0.001). Fewer side effects (50%) and convenience of home treatment (40%) were the main reasons for their choice for the oral regimen. UFT induced less mucositis (P = 0. 02) and diarrhoea (P = 0. 01). We conclude that convenience and lower toxicity may explain the observed preference for oral UFT.

Administration, Oral↗
PubMed1987

Propafenone versus disopyramide: a double-blind randomized crossover trial in patients presenting chronic ventricular arrhythmias.

In vitro and in vivo electrophysiological studies have shown that propafenone could be classified as a class I antiarrhythmic agent. The aim of this study was to investigate the short-term antiarrhythmic efficacy and safety of propafenone in 10 patients compared to disopyramide in a double-blind randomized protocol. Included patients suffered from ventricular arrhythmias with at least 60 ventricular premature beats (VPB) per hour refractory to at least two other antiarrhythmic agents. At the end of the control period and of the two treatment periods during which patients received either propafenone (300 mg three times a day) or disopyramide (200 mg three times a day), clinical examination, Holter recordings, electrocardiogram, and clinical laboratory tests were performed. The PR interval and the QRS interval were significantly increased with propafenone, but not with disopyramide. The cQT interval was not significantly changed by either propafenone or disopyramide. Heart rate was decreased with propafenone (p less than 0.05) with no change in the diurnal/nocturnal circadian ratio variation. Heart rate was significantly decreased with disopyramide only during the day. Five of nine patients in the propafenone group and two of nine patients in the disopyramide group showed a reduction in ventricular premature beats greater than 80%. Total resolution of severe arrhythmias (repetitive events) was seen in 5 of 8 patients with propafenone; 2 of 8 with disopyramide. Adverse events, when they occurred, were mild (visual disturbances, epigastric discomfort, changes in taste perception, transient atrioventricular block with propafenone, and photophobia with disopyramide), and did not require reduction or discontinuation of study drug.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed2006

The effect of helium and oxygen on exercise performance in chronic obstructive pulmonary disease: a randomized crossover trial.

RATIONALE: Breathing supplemental oxygen reduces breathlessness during exercise in patients with chronic obstructive pulmonary disease (COPD). Replacing nitrogen with helium reduces expiratory flow resistance and may improve lung emptying. Combining these treatments should be independently effective. OBJECTIVES: Study the effect of changing oxygen or helium concentration in inspired gas during exercise in patients with stable COPD. METHODS: In 82 patients (mean age, 69.7 yr; mean FEV(1), 42.6% predicted), we measured endurance shuttle walking distance, resting and exercise oxygen saturation, and end-exercise dyspnea (Borg scale) while patients breathed Heliox28 (72% He/28% O(2)), Heliox21 (79% He/21% O(2)), Oxygen28 (72% N(2)/28% O(2)), or medical air (79% N(2)/21% O(2)). Gases were administered using a randomized, blinded, crossover design via a face mask and an inspiratory demand valve. RESULTS: Breathing Heliox28 increased walking distance (mean+/-SD, 147+/-150 m) and reduced Borg score (-1.28+/-1.30) more than any other gas mixture. Heliox21 significantly increased walking distance (99+/-101 m) and reduced dyspnea (Borg score, -0.76+/-0.77) compared with medical air. These changes were similar to those breathing Oxygen28. The effects of helium and oxygen in Heliox28 were independent. The increase in walking distance while breathing Heliox28 was inversely related to baseline FEV(1) breathing air. CONCLUSION: Reducing inspired gas density can improve exercise performance in COPD as much as increasing inspired oxygen. These effects can be combined as Heliox28 and are most evident in patients with more severe airflow obstruction.

Aged↗
PubMed2005

A randomized, crossover trial of high-carbohydrate foods in nursing home residents with Alzheimer's disease: associations among intervention response, body mass index, and behavioral and cognitive function.

BACKGROUND: Despite recognition that weight loss is a problem in elderly persons with probable Alzheimer's disease (AD), increasing their food intake remains a challenge. To effectively enhance intake, interventions must work with individuals' changing needs and intake patterns. Previously, the authors reported greater food consumption at breakfast, a high-carbohydrate meal, compared with dinner, and shifts toward carbohydrate preference at dinner in those with increased behavioral difficulties, low body mass index, or both. METHODS: Thirty-four nursing home residents with probable AD who ate independently participated in a randomized, crossover, nonblinded study of two nutrition interventions. The intervention described here included replacing 12 nonconsecutive "traditional" dinners with meals high in carbohydrate but comparable to traditional dinners in protein. Measures included weighed food intake, body weight, cognitive function (as assessed using the Severe Impairment Battery and Global Deterioration Scale), behavioral disturbances (as assessed using the Neuropsychiatric Inventory-Nursing Home Version), and behavioral function (as assessed using the London Psychogeriatric Rating Scale). RESULTS: Group mean dinner and 24-hour energy intake increased during the intervention phase compared with baseline, protein intake was unaffected, and carbohydrate intake increased. Increased dinner intake, attributable to intervention foods, was achieved in 20 of 32 of participants who completed the study and was associated with increased carbohydrate preference, poorer memory, and increased aberrant motor behavior. Those with low body mass indices were the most resistant to the intervention. CONCLUSIONS: Providing a high-carbohydrate meal for dinner increases food intake in seniors at later stages of the disease who are experiencing cognitive and behavioral difficulties, possibly as a result of a shift in preference for high-carbohydrate foods.

Aged↗
PubMed1981

Comparison of the antihypertensive activities of xipamide and chlorthalidone: a double-blind, randomized, crossover trial.

The effectiveness of a new potent diuretic, xipamide, was evaluated in the treatment of patients with mild to moderate essential hypertension. The effects of daily doses of 40 mg xipamide were compared with those of 100 mg chlorthalidone with respect to systolic and diastolic blood pressure, using a double-blind crossover design. Patients received each drug for 6 weeks, the order of treatments being at random and the periods being separated by a 'washout' period of 7 days. The results showed that xipamide was as effective as chlorthalidone in controlling blood pressure, both in the upright and supine positions, and when administered after chlorthalidone produced a further reduction. No such further reduction occurred when chlorthalidone was given after xipamide. Serum electrolyte changes induced by the two diuretics were comparable. Both drugs were well tolerated and caused few side-effects.

Adult↗
PubMed1998

A prospective crossover randomized trial of novobiocin and rifampin prophylaxis for the prevention of intravascular catheter infections in cancer patients treated with interleukin-2.

BACKGROUND: The aim of this study was to determine the efficacy of novobiocin and rifampin as oral antibiotic prophylaxis for the prevention of catheter-related infection in melanoma patients treated with interleukin-2 (IL-2) plus interferon-alpha and chemotherapy (biochemotherapy). METHODS: Patients with advanced melanoma who were treated with biochemotherapy at the University of Texas M. D. Anderson Cancer Center were randomized in a crossover study to receive either oral antibiotic prophylaxis consisting of novobiocin and rifampin or observation alone over a 35-day course period. Patients were subsequently "crossed over" to the opposite arm of the study for an additional 35-day period, with each serving as his or her own control. RESULTS: Twenty-six patients were enrolled. Nine patients (35%) failed to tolerate oral antibiotics because of severe nausea and vomiting; 17 patients (65%) were crossed over and considered evaluable. During the control patient courses, 71% of evaluable patients had infectious complications, 41% had a catheter-associated bacteremia, and 53% had a local catheter infection. In contrast, of the patients treated with antibiotic prophylaxis, only 12% had an infectious complication (P = 0.001), 12% had a local catheter infection (P = 0.008), and 6% had catheter-associated bacteremias (P = 0.04). Thirty-six episodes of catheter infections occurred during the 17 control courses, whereas only 3 episodes occurred during antibiotic prophylaxis (P < 0.001). CONCLUSIONS: Although more than one-third of patients receiving IL-2 treatment with biochemotherapy failed to tolerate novobiocin and rifampin, this oral antibiotic regimen was efficacious in preventing the infectious complications, especially those associated with vascular catheters, in this high risk patient population.

Administration, Oral↗
PubMed2001

Silent ischemic interval on exercise test is a predictor of response to drug therapy: a randomized crossover trial of metoprolol versus diltiazem in stable angina.

BACKGROUND AND HYPOTHESIS: There is no method available to predict the relative antianginal efficacy of beta blockers and calcium-channel antagonists. The present study was undertaken to assess the role of silent ischemic interval (SII) on exercise treadmill test (ETT) as a predictor of response to therapy with metoprolol and diltiazem in patients with stable angina. METHODS: Thirty-four patients with stable angina were divided into two groups depending upon the presence or absence of an SII gap of at least 1 min between onset of ST depression and appearance of angina on ETT. Metoprolol (50-100 mg twice daily) and diltiazem (60-120 mg three times daily) were randomly assigned for 6 weeks to patients in each group, and then patients were crossed over for further 6 weeks after a washout period of 2 weeks. Antianginal efficacy was assessed by clinical and exercise parameters. RESULTS: In patients with SII, the clinical responder rate was better with metoprolol than with diltiazem (90 vs. 60%, respectively), and on ETT, metoprolol produced significant improvement in the total exercise time (p< 0.01), time to 1 mm ST depression (p <0.01), time to angina (p <0.01), and a significant decrease in peak rate-pressure product (p<0.001), whereas diltiazem had no significant effect on exercise parameters. However, in patients without SII, metoprolol and diltiazem had a similar clinical responder rate (57%), and both produced a significant increase in total exercise time (p < 0.01), time to 1 mm ST depression (p < 0.01), and time to angina (p < 0.01). In addition, metoprolol had a significant effect on peak rate-pressure product (p < 0.001). CONCLUSION: Silent ischemic interval on ETT can be a predictor of response to antianginal therapy in stable angina, as patients with SII respond better to metoprolol and those without SII respond equally to both metoprolol and diltiazem.

Adrenergic beta-Antagonists↗
PubMed1996

A randomized crossover trial of levodopa in congestive heart failure.

BACKGROUND: The short- and long-term effects of levodopa (L-dopa), an oral dopaminergic prodrug, were assessed in patients with severe left ventricular dysfunction. METHODS AND RESULTS: Initially, 26 patients were included in the study group. After clinical, radiographic, and radionuclide examination, each patient underwent right heart catheterization (Swan-Ganz thermodilution catheter). Plasma noradrenaline levels were measured. In two patients, a favorable hemodynamic response to L-dopa was not observed, another two required permanent pacemaker implantation. These four patients were excluded from the study. Two patients required permanent pacemaker implantation. The remaining 22 patients with favorable hemodynamic response to L-dopa (increase in cardiac index, stroke volume index, reduction in total systemic resistance) were randomized in a nonblinded fashion to the conventional (11 patients) or conventional plus L-dopa (11 patients) treatment groups. During the study period, two patients, one from each group, died. They were excluded from the analysis. The final analyzed study group consisted of 20 men, aged 33-69, in New York Heart Association functional class IV (9 patients) and III (11 patients). The cause of congestive heart failure was primary dilated cardiomyopathy in 11 patients and ischemic heart disease in 9 patients. After 3 months' treatment, all patients were crossed over. Clinical, radiographic, radionuclide, and hemodynamic evaluation was repeated at the end of the 3-month treatment period. After 3 months of therapy with L-dopa in each group (covariance analysis), there was improvement in clinical, radiographic (relative heart volume, -128 mL/m2), radionuclide (left ventricular ejection fraction, +4.6; right ventricular ejection fraction, +4.8%), hemodynamic (mean pulmonary wedge pressure, -8 mmHg; total systemic resistance, -1.8 Wu; total pulmonary resistance, -3.5 Wu), and neurohumoral (noradrenaline, -218 pg/mL) measures. CONCLUSIONS: The addition of L-dopa to conventional therapy has beneficial short- and long-term effects in patients with severe left ventricular dysfunction.

Administration, Oral↗
PubMedDate not supplied

Airway clearance in bronchiectasis: a randomized crossover trial of active cycle of breathing techniques versus Acapella.

BACKGROUND: The efficacy of a new airway clearance device (Acapella) has not been previously investigated. Active cycle of breathing techniques (ACBT) is the standard airway clearance technique used in patients with bronchiectasis. OBJECTIVE: The objective of this study was to compare the efficacy of ACBT with Acapella as methods of airway clearance in adults with stable, productive bronchiectasis. METHODS: Twenty patients (7 males), age 58 +/- 11 years (mean +/- SD), FEV1 64 +/- 22% predicted with stable (change of not greater than FEV1 10% predicted during 3 months prior to study), productive (history of expectoration of half an egg cup sputum/day) bronchiectasis attended the respiratory clinic on 3 days. Day 1: 40-min training session on ACBT and Acapella. Days 2 and 3: 30-min treatment session of either ACBT or Acapella. Treatment order was determined by a concealed randomization procedure. The following outcomes were measured before and after treatment spirometry, SpO2 and breathlessness by an independent assessor who was blinded to treatment order. Weight of sputum (during treatment plus 30 min after treatment), number of coughs and patient preference were also recorded. RESULTS: No significant differences were found at baseline indicating that patients were stable. No significant differences were found between weight of sputum expectorated with ACBT treatment and weight of sputum expectorated with Acapella treatment--mean difference 0.54 g (95% CI -0.39 to 1.46). A greater proportion of patients preferred Acapella (14/20). CONCLUSION: Acapella is as effective a method of airway clearance as ACBT and may offer a user-friendly alternative to ACBT for patients with bronchiectasis.

Airway Obstruction↗
PubMed2001

Feasibility of tidal volume-guided ventilation in newborn infants: a randomized, crossover trial using the volume guarantee modality.

BACKGROUND AND AIM: Volume guarantee (VG) is a new composite mode of pressure-limited ventilation, available on the Dräger Babylog 8000 ventilator, which allows the clinician to set a target mean tidal volume to be delivered while still maintaining control over peak airway pressures. This study aimed to investigate the feasibility and efficacy of this mode of ventilation in premature newborn infants with respiratory distress syndrome (RDS). METHODS: Two groups of infants were studied: those receiving synchronized intermittent positive pressure ventilation (SIPPV) in early phase of RDS (group 1) and those in recovery phase of RDS being weaned from artificial ventilation through synchronized intermittent mandatory ventilation (SIMV; group 2). Both groups of infants were studied over a 4-hour period. Before the start of the study, the infants were either receiving SIPPV (group 1) or SIMV (group 2). Infants in group 1 were randomized to either continue on SIPPV for the first hour of the study or to receive SIPPV plus VG for the first hour. Subsequently, the 2 modes were used alternately for the remaining three 1-hour periods. Similarly, infants in group 2 were randomized to either continue on SIMV for the first hour of the study or to receive SIMV plus VG for the first hour. Data on ventilation parameters and transcutaneous carbon dioxide and oxygen were collected continuously. RESULTS: Forty infants were studied, 20 in each group. The mean (standard error) gestational age was 27.9 (0.3) weeks; birth weight was 1064 (60) g. No adverse events were observed during the study. Fractional inspired oxygen during SIMV plus VG was 0.31 (0.3); during SIMV, 0.31 (0.3); during SIPPV plus VG, 0.41 (0.4); and during SIPPV, 0.40 (0.4). Transcutaneous carbon dioxide pressure during SIMV plus VG was 6.0 (2.2) kPa; during SIMV, 5.9 (2.2) kPa; during SIPPV plus VG, 6.4 (2.9) kPa; and during SIPPV, 6.4 (2.8) kPa. Transcutaneous partial pressure of oxygen during SIMV plus VG was 8.4 (8.7) kPa; during SIMV, 8.6 (8.8) kPa; during SIPPV plus VG, 7.6 (4.0) kPa; and during SIPPV, 7.7 (4.2) kPa. None of these differences was statistically significant. The mean (standard error) peak inspiratory pressure used during SIMV was 17.1 (3.4) cm of water; during SIMV plus VG, 15.0 (7.5) cm of water; during SIPPV plus VG, 17.1 (9.3) cm of water; and during SIPPV, 18.7 (8.3) cm of water. The mean airway pressure during SIMV plus VG was 6.5 (3.1) cm of water; during SIMV, 6.9 (2.8) cm of water; during SIPPV plus VG, 9.6 (4.5) cm of water; and during SIPPV, 9.8 (4.6) cm of water. CONCLUSION: VG seems to be a stable and feasible ventilation mode for neonatal patients and can achieve equivalent gas exchange using statistically significant lower peak airway pressures both during early and recovery stages of RDS.ventilation, airway pressure, volume guarantee, tidal volume.

Birth Weight↗
PubMed1990

Double-blind randomized crossover trial of luteal phase estrogens (Premarin) in the premenstrual syndrome (PMS).

Eleven patients with moderate to severe premenstrual syndrome were given Premarin during the latter half of the menstrual cycle for at least two cycles, and a placebo for at least two cycles. Mental and physical symptoms were monitored daily with a self-rating scale. Premarin was significantly less effective than placebo in relieving the severity of both mental (p less than 0.02) and physical (p less than 0.02) symptoms of PMS (combined data p less than 0.01). It is concluded that luteal phase Premarin is ineffective as a treatment for PMS, and may actually aggravate the symptoms.

Adult↗
PubMed1992

A double-blind, randomized, crossover trial of pemoline in fatigue associated with multiple sclerosis.

Fatigue occurs in a majority of patients with MS and is generally independent of measurable neurologic disability. Few options for treatment are available. We conducted a double-blind, placebo-controlled, crossover trial for each of two 4-week treatment periods. Forty-six eligible patients entered and five dropped out due to concurrent exacerbations. Nineteen patients (46.3%) experienced excellent or good relief of fatigue with pemoline, and eight patients (19.5%) with placebo (p = 0.06, Fisher's exact test). One-fourth of patients did not tolerate the drug well, and 7% had to discontinue pemoline during the study due to side effects. The most common side effects were anorexia, irritability, and insomnia. Pemoline may be an effective short-term treatment for fatigue associated with MS, but its adverse effects are not well tolerated by many patients.

Adult↗
PubMed1993

The effect of fish oil on blood pressure in mild hypertensive subjects: a randomized crossover trial.

We conducted a double-blind, crossover trial with 18 healthy, untreated mildly hypertensive subjects to test the effect on blood pressure of 6 or 12 g fish oil/d (50% n-3 fatty acids) as compared with an olive oil placebo. Blood pressure was measured every 6 wk in the clinic and three times daily by subjects using a semiautomated device in their homes. Compliance was determined biochemically. No significant changes in home or clinic blood pressure measurements were noted for either dose after 6 or 12 wk of treatment. Clinic blood pressure after 12 g fish oil/d was slightly lower than after placebo treatment by -0.8/-0.4 mm Hg [95% CI: systolic blood pressure (-4.4, +2.8); diastolic blood pressure (-3.2, +2.4)]. Blood pressure changes were not correlated with compliance, baseline dietary fish consumption, or blood pressure. Moderate doses of fish oil did not have a substantial effect on blood pressure. We conclude that fish oil is not a practical treatment for mild hypertension.

Blood Pressure↗