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PubMed2006

Clinical use of a shortened alcohol withdrawal scale in a general hospital.

BACKGROUND: Multi-item scales for monitoring alcohol withdrawal reactions have been used since the 1970s, and since 1985 we have used a modified version of the Clinical Institute Withdrawal Assessment (CIWA) in our general hospitals. This study was conducted to determine whether a shorter version of the scale would prove easier to use without loss of accuracy. METHODS: A simultaneous 'crossover' clinical audit using two hospitals. The shortened scale was developed from the existing one, and had 10 items as opposed to the previous 18. The patients were followed throughout their course and the incidences of complication, the frequency of sedation, the delay in initiating monitoring and the ease of use were recorded. RESULTS: There were 106 patients managed with the old scale and 96 with the new. The rate of complication was not different, being 16% in patients managed using the old scale and 14.5% using the new scale; the rates of sedation were 49 and 48%, respectively. Patients managed with the new scale had a shorter course with a median duration of 27.6 h compared with 40 h. The time from admission to first recording of a score was 5.4 h for the new scale and 4.8 h for the old, which is not a significant difference. Both scores were used according to instructions, but staff reported that the shortened scale was easier to use. CONCLUSIONS: We conclude that a shortened form of the CIWA alcohol withdrawal scale works as well as the original and is simple to use.

Adult↗
PubMed1983

Effect of dietary protein manipulation in subclinical portal-systemic encephalopathy.

Eight stable cirrhotic patients with mild or subclinical portal-systemic encephalopathy (PSE) were studied after shunt surgery when they were off all antiencephalopathic therapy. Equal amounts of mixed proteins were alternated with animal or vegetable protein in a crossover protocol under metabolic conditions for five consecutive, one week periods. The different dietary periods were not associated with either a change in the neurological impairment score or the Trailmaking Tests, which showed a learning effect. The peak frequencies of the computer analysed EEG (CAEEG) were lower during the animal (6.58 +/- 0.42 Hz) than the vegetable (7.10 +/- 0.44 Hz) diet (p 0.01). Neither arterial ammonia levels nor plasma amino acid ratios changed with the diets, whereas urinary 3-methyl-histidine excretion increased during the animal diet. During the vegetable diet the apparent nitrogen balance tended to be more positive than during either the mixed or animal diets associated with decrease in the urinary nitrogen excretion. The peak frequency of the CAEEG is the most sensitive test to monitor methods of treatment in portal-systemic encephalopathy. A vegetable protein diet, rather than overall protein restriction, should be considered in the management of this disorder, particularly when the nutritional state is poor.

Adult↗
PubMed1994

Transdermal clonidine for ameliorating tamoxifen-induced hot flashes.

PURPOSE: To determine the efficacy of transdermal clonidine for alleviating tamoxifen-induced hot flashes in women with a history of breast cancer. PATIENTS AND METHODS: A randomized, double-blind, crossover design was used in this prospective study. Women with a history of breast cancer who were receiving tamoxifen and suffering from hot flashes were potentially eligible for this protocol study. RESULTS: Clonidine did reduce hot-flash frequency to a degree that was statistically impressive (P < .0001), but clinically moderate (20% reduction from baseline). It also decreased hot-flash severity (P = .02, 10% reduction from baseline). Clonidine was related to increased mouth dryness (P < .001), constipation (P < .02), itchiness under the patch (P < .01), and drowsiness (P < .05). CONCLUSION: Better means are needed to alleviate hot flashes among patients in whom estrogen therapy is contraindicated.

Administration, Cutaneous↗
PubMed2004

Cognitive functioning after repetitive transcranial magnetic stimulation in patients with cerebrovascular disease without dementia: a pilot study of seven patients.

AIMS: Examine whether one session of high frequency repetitive transcranial magnetic stimulation (rTMS) applied over the left dorsolateral prefrontal cortex (DLPFC) would induce any measurable cognitive changes in patients with cerebrovascular disease and mild cognitive deficits. PATIENTS AND METHOD: Seven patients with cerebrovascular disease and mild executive dysfunction entered the randomised, controlled, blinded study with a crossover design. rTMS was applied either over the left DLPFC (an active stimulation site) or over the left motor cortex (MC; a control stimulation site) in one session. Each patient participated in both stimulation sessions (days 1 and 4) and the order of stimulation sites (DLPFC or MC) was randomised. A short battery of neuropsychological tests was performed by a blinded psychologist prior to and after each rTMS session. Psychomotor speed, executive function, and memory were evaluated. RESULTS: The only mild but significant stimulation site-specific effect of rTMS was observed in the Stroop interference results (i.e. improvement) after the stimulation of DLPFC but not MC in comparison with the baseline scores (Wilcoxon, Z=-2.03, p=0.04). Patients improved in the digit symbols subtest of the Wechsler adult intelligence scale-revised after both rTMS sessions regardless of the stimulation site (DLPFC or MC; Z=-2.06, p=0.04 and Z=-2.06, p=0.04, respectively). There was no measurable effect of rTMS in any other neuropsychological test. CONCLUSION: Our pilot study results showed that one session of the high frequency rTMS applied over the left DLPFC was safe in patients with cerebrovascular disease and mild executive deficits, and may induce measurable positive effects on executive functioning.

Aged↗
PubMed1994

Bipolar versus monopolar sphincterotomy: a prospective trial.

OBJECTIVES: To determine the frequency of complications, specifically pancreatitis, associated with endoscopic sphincterotomy, comparing the standard, monopolar electrocautery current to the bipolar system. METHODS: One-hundred consecutive patients requiring ERCP and sphincterotomy, 50 patients in each group, were randomized to receive a sphincterotomy using either the bipolar system (Bitome) or the standard monopolar system. Cannulation with the selected sphincterotome was successful in 92 patients, but crossover to the other system was necessary in eight patients, five bipolar and three monopolar. The performance of sphincterotomy was conducted similarly and by the same investigator. Excessive manipulation of the papilla during difficult cannulation was avoided, and no pre-cut, needle knife, or wire-guided assisted cannulation techniques were used in either group. RESULTS: Complications were assessed during follow-up review of charts and telephone interviews. Pancreatitis did not occur in the bipolar group; however, six patients in the monopolar group developed clinical and biochemical evidence of pancreatitis (p < 0.047). CONCLUSIONS: Sphincterotomy using bipolar technology appears to reduce the frequency of pancreatitis when compared to monopolar technology in a prospective, randomized fashion. Because bipolar electrocautery current is localized to the accessory tip, radiofrequency does not encounter impedance through the patient's body mass, and tissue injury is reduced. This fact may account for the decreased incidence of pancreatitis in the bipolar group. Larger studies are called for to support this conclusion.

Cholangiopancreatography, Endoscopic Retrograde↗
PubMed2006

Progesterone acutely increases LH pulse amplitude but does not acutely influence nocturnal LH pulse frequency slowing during the late follicular phase in women.

Progesterone (P) is the primary effector of LH (and by inference gonadotropin-releasing hormone) pulse frequency slowing in cycling women, but the time course of this action is unclear. We hypothesized that P administration to estradiol (E2)-pretreated women would slow LH pulse frequency within 12 h. We studied eight normally cycling women in two separate cycles (follicular phase, cycle days 7-11). After 3 days of E2 pretreatment (0.2 mg/day via transdermal patches), a 25-h blood sampling protocol (starting at 0800) was performed to define LH pulsatility. Oral micronized P (100 mg) or placebo (PBO) was administered at 1800 in a randomized, double-blind fashion, with treatment crossover occurring during a subsequent cycle. The 10-h mean P concentration increased from 0.6+/-0.1 ng/ml before P (0800-1800) to 3.9+/-0.3 ng/ml after P administration (2200-0800, P<0.01). Ten-hour mean LH interpulse interval increased significantly after both P and PBO administration, with no significant difference between P and PBO. In contrast, mean LH, LH amplitude, and mean FSH increased significantly within 4 h of P administration, but not after PBO. We conclude that, in E2-pretreated women in the late follicular phase, 1) nocturnal LH pulse frequency is not acutely (within 12 h) influenced by P administration; 2) an acute increase in P causes pronounced augmentation of gonadotropin pulse amplitude within 4 h; and 3) LH pulse frequency slows overnight during the second half of the follicular phase.

Administration, Oral↗
PubMed1994

Beneficial effects of metoprolol in heart failure associated with coronary artery disease: a randomized trial.

OBJECTIVES: This clinical trial was performed to determine the safety and clinical impact of titrated metoprolol therapy in patients with heart failure, documented coronary artery disease and a low ejection fraction. BACKGROUND: Despite known cardiodepressant effects, long-term use of beta-adrenergic antagonists appears to be beneficial in patients with idiopathic dilated cardiomyopathy. However, this therapy has not been critically evaluated in patients with heart failure and coronary artery disease. METHODS: In 50 patients with heart failure, known coronary artery disease and an ejection fraction < or = 0.40, we examined the impact of metoprolol therapy in a 6-month double-blind, placebo-controlled randomized trial, assessing the frequency of heart failure exacerbations and changes in symptoms (New York Heart Association functional class), ejection fraction and exercise duration. Placebo-treated patients who completed 6-month follow-up studies then underwent a trial with metoprolol therapy (crossover group). RESULTS: Metoprolol was titrated to a mean maximal dose of 87 mg/day (range 25 to 100) without serious adverse reactions. During double-blind therapy, use of a beta-blocker was associated with a significant reduction in the number of hospital admissions (4% vs. 32%, p < 0.05), overall improved functional class (p = 0.02), increased ejection fraction (4 +/- 7% [mean +/- SD] compared with 0 +/- 6%, p < 0.05) and a greater increase in exercise duration (193 +/- 276 vs. 38 +/- 213 s with placebo, p < 0.01). Crossover outcome paralleled the favorable impact seen during randomized metoprolol therapy. CONCLUSIONS: Cautious use of titrated metoprolol appears to be safe and beneficial when added to standard heart failure therapy in patients with dilated cardiomyopathy associated with coronary artery disease.

Coronary Disease↗
PubMedDate not supplied

Vigabatrin in complex partial seizures: a long-term study.

The efficacy and safety of oral vigabatrin (VGB) as add-on therapy in the long-term treatment of poorly controlled epilepsy were evaluated in 19 patients with complex partial seizures, either with or without secondary generalization. The study was run with a single-blind, placebo-controlled, crossover design, and included 2 months of placebo and 13-15 months of treatment with VGB, at doses ranging from 1 to 4 g/day. Of the 14 patients who completed the trial, 2 were seizure free, in 5 seizure frequency dropped by more than 75% and in another 5 by more than 50% with respect to baseline. The decrease in seizure frequency in the group as a whole was significant at all observation points of the trial. Three patients were not entered into the long-term phase due to lack of improvement (an increase in seizure frequency was observed in one of them), and 2 were excluded later because improvement disappeared leading to unauthorized changes in comedication. Side effects were mild and never caused discontinuation of treatment. In conclusion, VGB showed a remarkable efficacy and safety in the long-term treatment of complex partial seizures.

Administration, Oral↗
PubMed1980

A comparison between bromocriptine and indomethacin in the treatment of detrusor instability.

Our 32 patients with urinary symptoms owing to detrusor instability (either primary or secondary to an upper motor neuron lesion) have completed a clinical trial of bromocriptine and indomethacin. Each drug was administered for 1 month, using a single blind crossover method. The symptoms and any side effects were assessed by means of a questionnaire before entry into the trial, after administration of the first drug and at the end of the trial. The improvement in diurnal and nocturnal frequency owing to indomethacin was shown by McNemar's test to be statistically highly significant.

Bromocriptine↗
PubMed1999

Ursodeoxycholic acid has no influence on function after restorative proctocolectomy in ulcerative colitis.

BACKGROUND: Poor pouch function is associated with impaired bile acid absorption and increased faecal loss of bile acids. Bile acid replacement therapy might therefore be of clinical benefit, provided that diarrhoea is not aggravated by therapy. AIM: To investigate the role of exogenous bile acid therapy in patients with poor pouch function after restorative proctocolectomy for ulcerative colitis. PATIENTS AND METHODS: Twenty ulcerative colitis patients with poor pouch function (score > 4 on a 12-point score) were recruited for inclusion to a prospective, randomized, double-blind crossover, placebo-controlled trial of ursodeoxycholic acid (10 mg/kg per day in two divided doses for 1 month). RESULTS: A total of 16 patients completed the study. There was no significant difference in the functional score or bowel frequency following treatment irrespective of whether the active treatment was given before or after placebo. CONCLUSIONS: We conclude that ursodeoxycholic acid given over 4 weeks had no influence on functional score or bowel frequency after restorative proctocolectomy for U.C.

Adult↗
PubMed1990

Interaural attenuation using etymotic ER-3A insert earphones in auditory brain stem response testing.

Click interaural attenuation (IA) was measured behaviorally and with the auditory brain stem response (ABR) in two unilaterally deaf adults with Etymotic ER-3A insert earphones, and TDH-39P and TDH-49P supraaural earphones. Stimulus crossover for each set of earphones was also determined with pure-tone audiometry. Pure-tone results agreed with previous research, showing that the ER-3A provided substantially greater IA than the supraaural earphones, particularly for low frequencies. For click stimuli, behavioral and ABR results revealed only modest, if any, improvement in IA with the ER-3A relative to the supraaural earphones. The results of this study suggest that while the ER-3A earphones provide a clear IA advantage for behavioral pure-tone audiometry, they do not eliminate the need for contralateral masking of click stimuli in ABR testing.

Adult↗
PubMed1990

Clinical benefit of transdermal glyceryl trinitrate when used with an eight hour patch-free period.

The 24-hour application of transdermal nitrate patches has been associated with rapid development of therapeutic tolerance. Recent reports suggest maintenance of clinical benefit by introducing a daily patch-free period. This study investigates, by means of serial treadmill testing, the efficacy of a new transdermal delivery system when used with an eight hour patch-free period in 16 subjects with chronic stable angina. Concomitant antianginal therapy was permitted. After demonstration of exercise test reproducibility and nitrate responsiveness, subjects entered a double-blind randomised placebo-controlled crossover trial comprising one week of active nitroglycerin patches (10mg/24hrs) and one week of an identical placebo patch. Exercise tests were conducted four hours after patch application on the last day of each of the treatment arms. Daily angina frequency and nitroglycerin consumption were also monitored. There was significant improvement in total exercise duration (16.5%), time to onset of angina (26%), time to 1mm ST depression (22%), and peak heart rate blood pressure product with active patch application. Angina frequency was reduced during the week of active therapy. These results demonstrate the additional efficacy of intermittent transdermal nitroglycerin in a group of subjects with continuing angina despite therapy with beta-blockers and calcium antagonists.

Administration, Cutaneous↗
PubMed1984

Fluphenazine/nortriptyline in the irritable bladder syndrome. A double-blind placebo controlled study.

A double-blind, placebo controlled, randomised order crossover study was carried out on the effect of Motival (0.5 mg fluphenazine with 10 mg nortriptyline) 3 times daily on the bladder function and psychiatric morbidity of 13 women without evidence of infection, complaining of recurrent dysuria and frequency. Bladder function was assessed symptomatically and by ambulatory urodynamics, and patients completed the General Health Questionnaire, a validated instrument for the detection of psychiatric disturbance. Correction of the urodynamic abnormalities was associated with Motival treatment in 5 of the 8 patients with unstable bladders, compared with none of 7 patients receiving placebo (P less than 0.02). Motival was also associated with a greater frequency of symptomatic improvement. Only 2 patients were classified as psychiatrically disturbed, suggesting that the therapeutic effect of Motival is not related to its psychotropic properties.

Adolescent↗
PubMed1991

The length of homology required for gene targeting in embryonic stem cells.

Homologous recombination has been used to introduce site-specific mutations into murine embryonic stem (ES) cells with both insertion and replacement vectors. In this study, we compared the frequency of gene targeting with various lengths of homology and found a dramatic increase in targeting with an increase in homology from 1.3 to 6.8 kb. We examined in detail the relationship between the length of homology and the gene-targeting frequency for replacement vectors and found that a critical length of homology is needed for targeting. Adding greater lengths of homology to this critical length has less of an effect on the targeting frequency. We also analyzed the lengths of homology necessary on both arms of the vector for gene replacement events and found that 472 bp of homology is used as efficiently as 1.2 kb in the formation and resolution of crossover junctions.

Animals↗
PubMed2002

Unprotected carotid artery stenting compared to carotid endarterectomy in a community setting.

PURPOSE: To evaluate the feasibility and safety of carotid artery stenting (CAS) performed by a dedicated multidisciplinary team in a community hospital. METHODS: Forty-nine patients (30 men; mean age 74.3 +/- 7.4 years, range 51-88) with 14 symptomatic and 35 asymptomatic >50% carotid stenoses were enrolled into the study and treated with self-expanding stents without cerebral protection. The patients were evaluated at 30 days for death, neurological sequelae, and length of stay. A contemporaneous group of 140 patients (80 men; mean age 72.3 +/- 7.7 years, range 43-89) undergoing carotid endarterectomy (CEA) was used for comparison of the outcome measures. Owing to crossover of failed CAS patients to the CEA group, the data were analyzed according to intention-to-treat and treatment-received. RESULTS: The only difference in baseline characteristics between the treatment and control groups was the greater frequency of bilateral disease in the CEA group (p=0.009). The CAS procedures were successful in 47 (96.0%) patients; 2 access failures were converted to endarterectomy, and 1 access-site pseudoaneurysm was treated surgically. There were no deaths or myocardial infarctions in either group. In the CAS group, there were no major and only 2 (4.1%) minor strokes compared to 4 (2.9%) major and 4 (2.9%) minor strokes in the CEA group (p>0.05). Median LOS was significantly lower in the CAS group (p<0.0001). CONCLUSIONS: Careful case selection and multidisciplinary collaboration facilitate the safe performance of carotid stenting in a community setting with acceptable early results.

Adult↗
PubMed1994

Alcohol and managerial performance.

Effects of alcohol intoxication at .05 and .10 breath alcohol concentration upon a number of validated indicators of managerial performance were investigated in a double-blind crossover placebo-controlled simulation design. Managers (N = 48) spent 2 days handling quasi-experimental (partially event-controlled) tasks that permitted realistic managerial decision making under both "normal" and "emergency" conditions. The data showed that speed and frequency of managerial action were affected by alcohol at the .10 but not the .05 level. Strategy and planning deteriorated at both levels. Limited improvement of performance was observed for one simpler component of managerial functioning at the lower intoxication level, possibly due to myopia and/or a motivated "strain" toward better performance induced by the perception of impairment.

Adult↗
PubMed2000

Comparative safety of filgrastim versus sargramostim in patients receiving myelosuppressive chemotherapy.

STUDY OBJECTIVE: To compare rates of adverse events with filgrastim versus sargramostim when given prophylactically to patients receiving myelosuppressive chemotherapy. DESIGN: Retrospective review with center crossover. SETTING: Ten United States outpatient chemotherapy centers. PATIENTS: Four hundred ninety patients treated for lung, breast, lymphatic system, or ovarian tumors. INTERVENTION: Prophylactic use of filgrastim or sargramostim, with dosages at investigator discretion. MEASUREMENTS AND MAIN RESULTS: The frequency and severity of adverse events and the frequency of switching to the alternative CSF were assessed. There was no difference in infectious fever. Fever unexplained by infection was more common with sargramostim (7% vs 1%, p<0.001), as were fatigue, diarrhea, injection site reactions, other dermatologic disorders, and edema (all p<0.05). Skeletal pain was more frequent with filgrastim (p=0.06). Patients treated with sargramostim switched to the alternative agent more often (p<0.001). CONCLUSION: Adverse events were less frequent with filgrastim than with sargramostim, suggesting that quality of life and treatment costs also may differ.

Antineoplastic Agents↗
PubMed2004

Effects of exchange of dietary medium chain triglycerides for long-chain triglycerides on serum biochemical variables and subjectively assessed well-being of dogs with exocrine pancreatic insufficiency.

OBJECTIVE: To test the hypothesis that exchange of medium-chain triglycerides (MCTs) for long-chain triglycerides (LCTs) in the diet of dogs with well-managed exocrine pancreatic insufficiency (EPI) changes serum biochemical variables and to subjectively assess the well-being of dogs with EPI in response to experimental diets. ANIMALS: 21 dogs with EPI and 6 healthy control dogs. PROCEDURE: The effects of 3 diets containing 0%, 16%, or 35% of the total fat content as MCTs were examined in a randomized controlled double-blind crossover trial. The 3 diets were fed for 12 weeks each. Dietary effects were evaluated by both subjective and objective variables. RESULTS: Analysis of subjective data revealed no significant difference in appetite, attitude, drinking behavior, volume of feces, defecation frequency, color of feces, consistency of feces, flatulence, or borborygmus among dogs fed the 3 experimental diets. A high MCT content in the diet was associated with significantly higher serum vitamin E, cholesterol, triglyceride, retinyl stearate, retinyl palmitate, and total vitamin A concentrations in dogs with EPI and significantly higher serum vitamin E concentrations in control dogs, compared with low MCT content. High MCT content in the diet was also associated with significantly lower concentrations of serum linoleic acid (C18:2[n-6]) in dogs with EPI and in control dogs, compared with low MCT content. CONCLUSIONS AND CLINICAL RELEVANCE: A high MCT content in the diet leads to increases in serum concentrations of cholesterol and certain fat-soluble vitamins. However, no effect was found on the subjective well-being of the dogs as evaluated by their owners.

Animals↗