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Results for “randomized crossover trial”

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At least 793 records · Page 44Linked to original sources

PubMed1991

Helium-oxygen mixture in the treatment of postextubation stridor in pediatric trauma patients.

OBJECTIVE: To assess the effectiveness of a helium-oxygen mixture in reducing post-extubation stridor in children hospitalized for burns or trauma. DESIGN: Randomized, controlled crossover trial. SETTING: Harborview Medical Center's Burn and Trauma ICUs from March to September 1989. PATIENTS: Children less than 15 yr old who were electively extubated and had symptoms of postextubation stridor, but required less than or equal to 35% oxygen. INTERVENTION: Each treatment (helium-oxygen and oxygen-supplemented room air) was given in random order for 15 min after extubation. MEASUREMENTS: Respiratory distress was assessed by a physician blinded to treatment order using a standard stridor score and clinical judgment. RESULTS: There were 13 children with 15 extubations; seven (47%) of 15 patients required subsequent treatment with racemic epinephrine or reintubation. Stridor scores were lower with helium-oxygen than with oxygen-supplemented room air (2.8 vs. 3.7, p less than .005), and helium-oxygen was preferred in eight of nine trials in which one treatment was clearly favored by the physician. CONCLUSION: Because helium-oxygen therapy can reduce stridor scores and is clinically preferred by physicians caring for stridorous children, it may be a useful adjunctive therapy in pediatric trauma patients with postextubation stridor.

Adolescent↗

PubMed2002

Efficacy and safety of a novel combination of L-arginine glutamate and yohimbine hydrochloride: a new oral therapy for erectile dysfunction.

PURPOSE: The goal of this double-blind, placebo-controlled, three-way crossover, randomized clinical trial was to compare the efficacy and safety of the combination of 6g of L-arginine glutamate and 6 mg of yohimbine hydrochloride (AY) with that of 6 mg of yohimbine hydrochloride (YP) alone and that of placebo (PP) alone, for the treatment of erectile dysfunction (ED). MATERIALS AND METHODS: Forty-five patients were included in this study. During each of the 2-week, crossover periods, drug was administered orally, one to two hours before intended sexual intercourse. The primary endpoint was change in the Erectile Function Domain score of the International Index of Erectile Function (IIEF). The secondary endpoints were patient and investigator assessments of treatment success. RESULTS: At the end of each treatment period, the Erectile Function Domain scores for AY, YP and PP were 17.2+/-7.17, 15.4+/-6.49 and 14.1+/-6.56, respectively. The difference between AY and PP was statistically significant (p=0.006). When stratified according to baseline scores over 14, those patients with mild to moderate MED had a better Erectile Function Domain response to treatment (AY=22.2+/-4.99, YP=18.2+/-5.59, PP=16.9+/-6.91, respectively) than those with scores 14 and below (AY=12.4+/-5.48, YP=12.7+/-6.25, PP=11.4+/-5.02, respectively). Investigators' and patients' assessment of efficacy was significantly improved by YP over PP. CONCLUSIONS: This pilot study shows that the on-demand oral administration of the L-arginine glutamate 6g and 6 mg yohimbine combination is effective in improving erectile function in patients with mild to moderate ED. It appears to be a promising addition to first-line therapy for ED.

Administration, Oral↗

PubMed2002

Fluoride-releasing elastomeric ligatures assessed with the in situ caries model.

The in situ caries model was used to assess the clinical benefit of fluoride-releasing elastomeric ligatures. The design of the experiment was a longitudinal, prospective, randomized, crossover clinical trial. Fourteen individuals starting orthodontic treatment with fixed appliances were recruited. Three in situ enamel specimens, with preformed subsurface carious lesions, were prepared for each patient, from human premolars. Two were placed in customized holders and one was retained as a control specimen. A crossover design was used so that patients had two experimental periods of six weeks with either fluoridated or non-fluoridated elastomerics, and a washout between. Elastomerics were randomly allocated at the first visit and one enamel specimen was placed at the beginning and collected at the end of each experimental period. The specimens were sectioned and ground to 100 microns, and transverse microradiography was carried out. They were analysed using dedicated computer software. The outcome measure was the change in the parameters of the pre-formed carious lesion, expressed as mineral loss (delta Z), lesion depth (ld), lesion width (lw), and ratio (delta Z/ld) between the three specimens. The mean mineral loss (vol %.micron) for the control specimen was 403.7 (+/- 139.5), compared with 599.3 (+/- 515.4) for the non-fluoridated ligatures and 477.2 (+/- 298.4) for the fluoridated ligatures. A one-factor within subjects ANOVA showed no statistical difference between the groups (P = 0.376). Fluoride-releasing ligatures do not provide a significant anti-cariogenic benefit in patients undergoing orthodontic treatment. This may be due to the short-term nature of the fluoride release. However, they might affect the local environment surrounding the bracket.

Adolescent↗

PubMed2006

Adaptive mechanical backup ventilation for preterm infants on respiratory assist modes - a pilot study.

BACKGROUND: Mechanical respiratory-assist modes, such as assist/control, low-rate intermittent mandatory ventilation, continuous positive airway pressure, or proportional assist ventilation (PAV), require a continuous respiratory effort. Because of the frequent occurrence of periodic breathing and/or apnea, mechanical backup ventilation must be initiated during episodes of reduced or absent respiratory drive to maintain gas exchange. The common approach to this problem is a regular conventional mechanical ventilation, which is initiated and withdrawn in an "on/off" function. OBJECTIVE: To develop and evaluate a mechanical backup ventilation mode that is adaptive to the rapidly changing breathing pattern of preterm infants. DESIGN: Prospective randomized clinical crossover trial. SETTING: Neonatal intensive care unit at the University of Munich, Germany. PATIENTS: Preterm infants undergoing PAV. INTERVENTIONS: The infants were ventilated with PAV using a newly developed adaptive backup support, with and without pulse-oximetry-guided operation (SpO(2)-sensitive backup). Each infant was ventilated with both modes of backup support on 2 consecutive days, with the sequence randomized. MEASUREMENTS AND RESULTS: The analysis on 11 preterm infants showed a statistically significant and clinically relevant reduction of the incidence (33%) and duration of oxygen desaturations (52%) when SpO(2)-sensitive adaptive backup support was used. CONCLUSIONS: SpO(2)-sensitive adaptive backup proved safe and effective in reducing the incidence and duration of oxygen desaturation in this short-term trial. This technology is potentially applicable to other assisted modalities of ventilation, such as noninvasive nasal ventilation.

Female↗

PubMedDate not supplied

Randomized controlled pilot trial of a hand-held patient-oriented, insulin regimen optimizer.

A robust, hand-held, patient-oriented insulin regimen optimizer (POIRO) has been developed. Relevant information is entered by selecting appropriate items from choices displayed on a touch-sensitive screen rather than a conventional keyboard. All data items are recorded, together with their time and date of entry, and may be recalled at any time with glucose values displayed graphically to provide an overview of glycaemic control. When requested, an integral, hybrid, statistical and rule-based expert system program uses all available data to suggest an optimum insulin dose within physician determined, pre-set limits. POIRO has been formally evaluated in a randomized crossover pilot trial, comparing two 3 week periods with and without decision support, in six patients with type 1 diabetes. Mean (SE) pre-prandial blood glucose levels were significantly lower during the period when decision support was available (7.5 (0.4) versus 8.9 (0.4) mmol/l, p = 0.015) with no increase in the frequency or severity of hypoglycaemia. The device, which was well received by the patients, may offer a relatively inexpensive method of providing expert diabetic advice at a distance. The persistence of improved glycaemic control, even after decision support was switched off, suggests the device could be used intermittently by patients and may have educational value.

Algorithms↗

PubMed2003

Effects of contact lens care solutions on surface exfoliation and bacterial binding to corneal epithelial cells.

PURPOSE: The purpose of this study is to assess the effects of commercially available contact lens wetting solutions on bacterial binding and cell exfoliation rates in human corneal epithelium. METHODS: The effects of four contact lens care solutions were tested: ReNu Multi Plus (Bausch & Lomb, Rochester, NY) multipurpose solution; OPTI-FREE Express (Alcon, Ft. Worth, TX) multipurpose solution; Complete Blink-N-Clean (Allergan, Irvine, CA) lens drops; and Lens Plus (Allergan) rewetting drops. STUDY DESIGN: Prospective, double-masked, randomized crossover clinical trial (N = 20 subjects). OUTCOME MEASURES: Measures of outcome included binding of Pseudomonas aeruginosa (PA) to exfoliated corneal epithelial cells, and the rate of surface cell exfoliation. Cells were collected at the baseline (pretreatment) examination and 4 days later, after subjects used the assigned solution six times daily and once again immediately before cell collection (posttreatment). Following cell collection, patients underwent 1 week of recovery, during which no drops were used, and random cross-over assignment to the next test solution. RESULTS: Use of test solutions increased PA binding, with a range of + 11.9% to + 58.2%. Analyzed together, PA binding increased significantly (+ 29%; P = 0.02, paired t-test); Lens Plus solution alone raised PA binding levels significantly (P = 0.022, 2-way ANOVA, Student-Newman-Keuls [SNK] test). Exfoliation rates were decreased from -7% to -52.7%. Analyzed together, cell exfoliation decreased significantly (P = 0.004; Wilcoxon signed rank test). Individual use of OPTI-FREE decreased exfoliation significantly (P = 0.019: 2-way ANOVA, SNK test). CONCLUSIONS: Topical application of common commercial contact lens care solutions increases PA binding and reduces corneal surface cell exfoliation. Similar effects have also been reported with contact lens wear. Taken together, the data suggest that the use of lens solution itself may play a role in increasing PA binding to corneal epithelial cells and, hence, might potentially contribute inadvertently to increased risk for lens-related microbial keratitis.

Adult↗

PubMed1987

Autologous blood perfusion for myocardial protection during coronary angioplasty: a feasibility study.

During coronary angioplasty, inflation of the balloon within the coronary artery produces transient arterial occlusion and frequently results in myocardial ischemia. Delivery of oxygenated autologous blood to the myocardium at risk during inflation may help mitigate this ischemia. Accordingly, we investigated the feasibility and safety of infusing blood through the central lumen of a dilatation catheter around the guidewire using both a model in vitro and clinical trials. In the tests in vitro, fresh blood was infused at flow rates up to 120 ml/min. Hemolysis was minimal at flow rates of 60 ml/min or less (less than or equal to 0.92 +/- 0.18%), but increased exponentially at higher rates (13.64 +/- 2.37% at 120 ml/min, p less than .002). A similar pattern was observed for potassium release. Platelet and leukocyte counts did not vary significantly, and beta-thromboglobulin and muramidase remained at control levels. Although mean erythrocyte volume did not change, erythrocyte histograms and light microscopy demonstrated a subpopulation of red cell fragments averaging 25 to 40 fl in size at higher rates. A randomized, crossover clinical trial was next performed by delivery of blood perfusion at 60 ml/min to 15 patients undergoing coronary angioplasty. Levels of plasma hemoglobin, beta-thromboglobulin, lactate dehydrogenase, and potassium remained constant before and after the perfusion and the control inflations. The maximum pain score was significantly lower with the perfusion inflation (4.1 +/- 0.8 vs 6.0 +/- 0.9, p less than .003). Relative to baseline, the maximum ST segment elevation during the perfusion inflation (0.5 +/- 0.3 mm) was nearly one-fourth that during the control inflation (1.9 +/- 0.6 mm, p less than .02). Thus, myocardial protection with oxygenated autologous blood perfusion at rates of 60 ml/min appears to be a safe and effective technique that may permit increased inflation time and extend the range of coronary angioplasty to include individuals at high risk for the procedure.

Angioplasty, Balloon↗

PubMed2002

A clinical study to evaluate the efficacy of ELA-Max (4% liposomal lidocaine) as compared with eutectic mixture of local anesthetics cream for pain reduction of venipuncture in children.

OBJECTIVE: A double-randomized, blinded crossover trial was performed to assess the efficacy of ELA-Max (4% liposomal lidocaine) as compared with eutectic mixture of local anesthetics (EMLA) for pain relief during pediatric venipuncture procedures. Safety was assessed by evaluation for topical or systemic effects and measurement of serum lidocaine concentrations. METHODS: A total of 120 children who were scheduled for repeat venipuncture for non-study-related reasons at 2 sites participated in the study. Patients were doubly randomized to treatment regimen (study medication application time of either 30 or 60 minutes) and to the order of application of the topical anesthetics for each venipuncture. The primary outcome measures were the child's rating of pain immediately after the venipuncture procedures using a 100-mm visual analog scale (VAS) tool and the parent's and blinded research observer's Observed Behavioral Distress scores. RESULTS: Both ELA-Max and EMLA seemed to alleviate venipuncture pain. There was no clinically or statistically significant difference in the patient VAS scores within the 30-minute or 60-minute treatment groups, and there was no clinical or statistical difference in VAS scores between the 30-minute ELA-Max treatment without occlusion and the 60-minute EMLA treatment with occlusion. There were no clinically or statistically significant differences between treatment with ELA-Max and EMLA in parental or blinded researcher Observed Behavioral Distress scores, the most frequent response at any observation time being "no distress." CONCLUSION: This study demonstrates that a 30-minute application of ELA-Max without occlusion is as safe and as effective for ameliorating pain associated with venipuncture as a 60-minute application of the prescription product EMLA requiring occlusion.

Adolescent↗

PubMed1991

Loop diuretics for chronic renal insufficiency: a continuous infusion is more efficacious than bolus therapy.

OBJECTIVE: To test the hypothesis that a continuous, low-dose infusion of a loop diuretic is more efficacious and better tolerated than conventional intermittent bolus therapy in patients with severe chronic renal insufficiency (CRI). DESIGN: Randomized, crossover clinical trial with subjects serving as their own controls. SETTING: The General Clinical Research Center of Indiana University Hospital, Indianapolis, Indiana. PATIENTS: Eight adult volunteers with severe stable CRI (mean creatinine clearance, 0.28 mL/s; range, 0.15 to 0.47 mL/s) were recruited from the outpatient nephrology clinics of Indiana University Medical Center. INTERVENTIONS: On admission, diuretic drugs were withdrawn and patients were equilibrated on an 80 mmol/d sodium, 60 mmol/d potassium metabolic diet. Patients were randomized to receive a 12-mg intravenous dose of bumetanide given either as two 6-mg bolus doses separated by 6 hours or as the same total dose administered as a 12-hour continuous infusion. When sodium balance was re-established, each patient was crossed over to the alternative study limb. All patients completed both phases of the study. MEASUREMENTS AND RESULTS: Comparable amounts of bumetanide appeared in the urine during the study period (infusion, 912 +/- 428 micrograms; bolus, 944 +/- 421 micrograms; difference, 32 micrograms; 95% CI, -16 micrograms to 80 micrograms, P = 0.16). The continuous infusion resulted in significantly greater net sodium excretion (infusion, 236 +/- 77 mmol; bolus, 188 +/- 50 mmol; difference, 48 mmol; CI, 16 mmol to 80 mmol, P = 0.01). No patient had episodes of drug-induced myalgias during the continuous infusion compared with 3 of 8 patients with bolus therapy. CONCLUSIONS: In patients with severe CRI, a continuous intravenous infusion of bumetanide is more effective and less toxic than conventional intermittent bolus therapy. Continuous administration will probably be useful in patients with severe CRI who have not achieved an adequate natriuresis or who show evidence of drug toxicity with standard diuretic dosing regimens. A similar benefit may occur in selected diuretic-resistant patients with cardiac or hepatic disease, and studies in these patients seem warranted.

Adult↗

PubMed1994

Inhibition of 5-fluorouracil-induced ocular irritation by ocular ice packs.

BACKGROUND: This clinical trial was developed to determine whether ocular ice pack therapy would decrease 5-fluorouracil (5-FU)-induced ocular toxicity. METHODS: Sixty-two patients who suffered from 5-FU-induced ocular toxicity, and were scheduled to receive another cycle of the chemotherapy that caused the ocular toxicity, were entered in this clinical trial. A randomized, crossover design was used, with patients documenting their ocular toxicity by the use of daily diaries. RESULTS: The results from the first cycle of treatment suggested that ocular ice pack therapy decreased 5-FU-induced ocular toxicity (P = 0.056). The 38 evaluable patients in the crossover analyses demonstrated decreased ocular toxicity with ocular ice pack therapy (p = .001). The ocular ice pack therapy was well tolerated by most of the study participants. CONCLUSION: Ocular ice pack therapy appears to lessen 5-FU-induced ocular toxicity to a clinically moderate degree. Better methods for decreasing 5-FU-induced ocular toxicity are necessary.

Conjunctivitis↗

PubMed2005

The efficacy and safety of the melatonin agonist beta-methyl-6-chloromelatonin in primary insomnia: a randomized, placebo-controlled, crossover clinical trial.

BACKGROUND: While melatonin agonists are known to regulate circadian sleep rhythms, it is not clear whether melatonin agonists have a direct soporific effect. It has been suggested that melatonin's soporific effect is secondary to its ability to induce hypothermia. beta-Methyl-6-chloromelatonin is a high-affinity melatonin receptor agonist that is not associated with hypothermia. The purpose of the present study was to determine if the melatonin agonist beta-methyl-6-chloromelatonin has a direct soporific effect in subjects with primary insomnia. METHOD: A double-blind, placebo-controlled, crossover safety and efficacy study of 20 mg, 50 mg, and 100 mg of beta-methyl-6-chloromelatonin and placebo was conducted in subjects with DSM-IV-TR primary insomnia. Of 84 subjects screened, 40 progressed to randomly receive each of 3 beta-methyl-6-chloromelatonin doses or placebo on each of 2 consecutive nights with 5-day washout periods between treatments. The effect of treatment on both polysomnographic and subjectively measured sleep parameters, next-morning psychomotor performance, and safety measures was determined. The primary outcome measure was latency to persistent sleep measured by polysomnography. RESULTS: A significant effect of beta-methyl-6-chloromelatonin on the primary efficacy variable, latency to persistent sleep, was observed (p = .0003). The 20-mg dose resulted in a significant 31% improvement in sleep latency compared with placebo, while significant 32% and 41% improvements were observed at the 50-mg and 100-mg doses, respectively (20 mg, p = .0082; 50 mg, p = .0062; 100 mg, p < .0001). Similarly, a significant effect of beta-methyl-6-chloromelatonin on subjective measures of time to fall asleep occurred (p = .0050), with significant improvement observed at both the 50-mg and 100-mg doses (p = .0350 and .0198, respectively) and a trend toward improvement observed at the 20-mg dose (p = .0582). Adverse events were mild to moderate in severity and did not differ in frequency between beta-methyl-6-chloromelatonin and placebo treatments. CONCLUSION: beta-Methyl-6-chloromelatonin significantly decreases both objective and subjective measures of sleep latency in subjects with primary insomnia. Thus, these data suggest that mel-atonin agonists may exert a direct soporific effect, as previous research indicates that beta-methyl-6-chloromelatonin is not associated with changes in body temperature, heart rate, or blood pressure.

Adult↗

PubMed1993

Two-thumb versus two-finger chest compression during CRP in a swine infant model of cardiac arrest.

STUDY OBJECTIVE: To test the hypothesis that two-thumb chest compression generates higher arterial and coronary perfusion pressures than the current American Heart Association-approved two-finger method. DESIGN: Randomized, crossover experimental trial. SETTING AND PARTICIPANTS: Animal laboratory experiment with seven swine of either sex weighing 9.4 kg (SD, 0.8 kg), representing infants less than 1 year old. INTERVENTIONS: Animals were sedated with IM ketamine/xylazine, intubated with a 6.0 Hi-Lo endotracheal tube, anesthetized with alpha-chloralose, and paralyzed with pancuronium. ECG was monitored continuously. Left femoral arterial and Swan-Ganz catheters were placed. Cardiac arrest was induced with an IV bolus of KCl and verified by ECG and pressure tracings. Five American Heart Association-certified basic rescuers were randomly assigned to perform external chest compressions for one minute by either the currently recommended two-finger method or the two-thumb and thorax-squeeze method. After all five completed their first trial, rescuers crossed over to the other method for a second minute of compressions. Ventilation was performed with a bag-valve device, and no drugs were given during CPR. After three complete cycles, the fourth through sixth cycles of compressions were recorded. Every compression was analyzed for arterial systolic, diastolic, mean, and coronary perfusion pressures. One thousand fifty compressions were analyzed with repeated-measures analysis of variance and Scheffé multiple comparisons. RESULTS: Systolic blood pressure, diastolic blood pressure, mean arterial pressure, and coronary perfusion pressure were all significantly higher (P < .001) with the two-thumb thoracic squeeze technique: systolic blood pressure, 59.4 versus 41.6 mm Hg; diastolic blood pressure, 21.8 versus 18.5 mm Hg; mean arterial pressure, 34.2 versus 26.1 mm Hg; and coronary perfusion pressure, 15.1 versus 12.2 mm Hg. CONCLUSION: The two-thumb method of chest compression generates significantly higher arterial and coronary perfusion pressures than the two-finger method in this infant model of cardiac arrest.

Animals↗

PubMed1993

Randomized, double-blind, placebo-controlled, two-period crossover clinical trial of psyllium fiber in children with hypercholesterolemia.

A randomized, double-blind, placebo-controlled, crossover clinical trial was designed to test the efficacy of psyllium fiber in lowering elevated low-density lipoprotein cholesterol (LDL-C) levels in children 5 to 17 years of age. Subjects with LDL-C levels > 2.84 mmol/L (110 mg/dl) after at least 3 months of a low total fat, low saturated fat, low cholesterol diet were enrolled. Two ready-to-eat cereals, with water-soluble psyllium fiber (6 gm/day) and without, were prescribed for 4 to 5 weeks each, with an intervening 2-week washout phase. Reported compliance rates exceeded 80% in the 20 subjects who completed the study. Mean initial total cholesterol, LDL-C, high-density lipoprotein cholesterol, and triglyceride values were 5.23, 3.60, 1.18, and 2.22 mmol/L, respectively. Comparison of the mean changes (from baseline) in lipid values after the two periods of cereal consumption revealed no statistically nor clinically significant differences in total cholesterol, LDL-C, or high-density lipoprotein cholesterol values. Triglyceride levels, however, increased 0.68 mmol/L (26 mg/dl; p < 0.05) after the control cereal in comparison with the psyllium cereal. No significant differences were noted in the children's dietary intake (assessed by 7-day diet records) during the two study periods. Measures of growth (height, weight, and skin-fold thicknesses), and blood vitamin (folic acid; vitamins A, D, and E) and mineral (iron, zinc, and calcium) levels were not affected. In this study, psyllium fiber had no additional lowering effect on total cholesterol or LDL-C levels in children who were already following low total fat, low saturated fat, low cholesterol diets.

Adolescent↗

PubMedDate not supplied

Muscle testing response to provocative vertebral challenge and spinal manipulation: a randomized controlled trial of construct validity.

OBJECTIVE: To evaluate the relationship of muscle strength response to a provocative vertebral challenge and to spinal manipulation. DESIGN: Prospective double-blind randomized controlled trial: crossover and between subjects designs. SETTING: Laboratory: Center for Technique Research. PARTICIPANTS: Sixty-eight naive volunteers from the student body, staff and faculty of the college. INTERVENTIONS: Provocative vertebral challenge: standardized 4-5 kg force applied with a pressure algometer to the lateral aspects of the T3-12 spinous processes. INTERVENTION: manual high velocity low amplitude adjustment or switched-off activator sham. MAIN OUTCOME MEASURES: Piriformis muscle response was defined in two ways: reactivity (a decrease in muscle resistance, yes or nor, following a vertebral challenge); responsiveness (the cessation of reactivity following spinal manipulation). Relative response attributable to the maneuver (RRAM): the percent of an outcome attributable to the challenge or adjustment itself. RESULTS: Average RRAM = 16% reactivity to vertebral challenge; average RRAM = 0% responsiveness to spinal manipulation. Six to 10% of muscle tests were positive regardless of examiner, previous finding or intervention. CONCLUSIONS: For the population under investigation, muscle response appeared to be a random phenomenon unrelated to manipulable subluxation. In and of itself, muscle testing appears to be of questionable use for spinal screening and post-adjustive evaluation. Further research is indicated in more symptomatic populations, different regions of the spine, and using different indicator muscles.

Adult↗

PubMed1995

Fetal acoustic stimulation, an adjunct to external cephalic version: a blinded, randomized crossover study.

OBJECTIVE: Our purpose was to determine whether fetal acoustic stimulation can improve the chance of successful external cephalic version in patients at 36 to 38 weeks' gestation with fetal midline spine position. STUDY DESIGN: A randomized, blinded crossover trial was performed. In this "N of 1" study, the patient served as her own control. RESULTS: Twenty-six patients were enrolled in the study, and three were excluded due to engagement of the fetal breech. In the initial trial with fetal acoustic stimulation to the maternal abdomen, 12 of 12 (100%) changed position to spine lateral and 11 of 12 (92%) were successfully verted. In the control group (fetal acoustic stimulation to nurse's arm), none of 11 (0%) changed position to spine lateral and one of 11 (9%) were successfully verted (p < 0.0001). In the crossover trial eight of 10 (80%) of the original placebo (control) patients were successfully verted after fetal acoustic stimulation to the maternal abdomen and none of 1 (0%) from the original treatment group were successfully verted after placebo fetal acoustic stimulation (p < 0.0001). Combined data from the original and crossover trials indicates 19 of 22 (86%) successful versions after fetal acoustic stimulation to maternal abdomen compared with one of 12 (8%) that had successful external cephalic version after placebo fetal acoustic stimulation. CONCLUSION: Fetal acoustic stimulation shifts fetal position to spine lateral, which increases successful version of fetuses with midline fetal spine presentations.

Acoustic Stimulation↗

PubMed1988

Comparison of a hydrocolloid dressing and paraffin gauze in the treatment of venous ulcers.

In-patients with venous leg ulcers showed increased healing rates with a hydrocolloid dressing (Granuflex), as compared with a traditional paraffin gauze dressing (Jelonet), in a randomized sequential crossover trial, although the difference was not statistically significant. Bacteriological studies showed that the hydrocolloid dressing favoured growth of both aerobes and anaerobes in significantly greater numbers compared with paraffin gauze. Heavy bacterial colonization had no effect on the healing rates of the ulcers. Granuflex is said to produce an anaerobic environment--survival of Pseudomonas aeruginosa, a strict aerobe, under Granuflex dressings, makes this seem unlikely.

Aged↗

PubMed2006

Predictive power of an in vitro system to assess drug interactions of an antimuscarinic medication: a comparison of in vitro and in vivo drug-drug interaction studies of trospium chloride with digoxin.

The authors studied a potential drug-drug interaction via findings from in vitro and in vivo studies, to assess whether the in vitro system was predictive of in vivo clinical pharmacokinetic outcomes. An in vitro experiment and a clinical study were performed to assess the potential for interaction. The effect of trospium chloride on human P-glycoprotein-mediated transport of [3H]-digoxin was determined in vitro. A randomized, crossover clinical trial in 40 subjects was performed to evaluate the effect of trospium on the pharmacokinetics of digoxin in vivo. The findings from the studies were then compared. The in vitro findings in this study were corroborated by the clinical study via assessment of inhibition and impact on pharmacokinetic parameters. The in vitro system for assessment of a potential interaction of 2 drugs excreted primarily through the kidney was predictive of the pharmacokinetic outcomes obtained from a clinical setting.

ATP Binding Cassette Transporter, Subfamily B, Mem↗

PubMed1997

Effect of total parenteral nutrition with different lipid emulsions of human monocyte and neutrophil functions.

Parenteral nutrition (TPN) with lipid emulsions is claimed to be associated with impaired monocyte (M) and neutrophil (N) functions. Long-chain triglycerides (LCT) and a mixture containing 50% medium-chain triglycerides (MCT) and 50% LCT, currently used in nutritional therapy with TPN, were evaluated for their ex vivo effects on human N and M chemotaxis, phagocytosis, bacterial killing, and oxidative metabolism by nitroblue tetrazolium reduction test. Cell functions were examined in a randomized, crossover, blind trial in 10 malnourished patients with gastric cancer. Prior to the operation (2 wk), central TPN (40 kcal/kg) with 25% of caloric energy provided as LCT or MCT/LCT emulsion was infused over 48 h. After the crossover period fat-free TPN was given over 48 h. Function tests were done for N and M before and after each lipid emulsion infusion. Every cell function test performed for each patient was controlled by another test done in healthy adult volunteers and the results were compared with the normal range of values previously established for a healthy adult population. All the patients completed the studies without complications. Crossover validity was statistically established. Bacterial killing was the only function reduced in neutrophils after LCT emulsion (% killed bacteria = 79.0 +/- 8.5 versus 67.4 +/- 19.2; P < 0.05), although this function remained within the normal range values in 80% of the patients. In conclusion, the lipid emulsions did not affect any monocyte functions and only moderately decreased neutrophil bacterial killing.

Aged↗