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Selected Abstracts

The glucose lowering effect of an oral insulin (Capsulin) during an isoglycaemic clamp study in persons with type 2 diabetes

DIABETES OBESITY & METABOLISM, Issue 1 2010
S. D. Luzio
Aim: Randomized, open, single-centre, two-way crossover study comparing the pharmacokinetic (PK) and pharmacodynamic (PD) properties of subcutaneous (sc) regular human insulin (Actrapid) and oral insulin in a capsule form (Capsulin). Methods: Sixteen persons (12 males) with type 2 diabetes on oral hypoglycaemic agents (OHAs) participated. Mean (s.d.) age 60.2 (5.5) years, BMI 28.3 (3.4) kg/m2, haemoglobin A1c (HbA1c) 7.4% (1.1). Two 6-h isoglycaemic glucose clamp studies were conducted 11 days apart. All subjects received in random order 12U sc Actrapid on one clamp study day and either 150U or 300U Capsulin (Cap) on the other day. Glucose infusion rates (GIRs), plasma insulin and C-peptide concentrations were determined throughout each 6-h isoglycaemic clamp. Between the clamp study days, all patients received 150U Capsulin twice daily, dropping all their standard OHAs apart from metformin. Self-monitored blood glucose (SMBG) levels were taken four times a day between the clamp study days. Results: Administration of either Actrapid or Capsulin (150 and 300U) increased GIRs reaching a maximum values at approximately 280,330 min. Overall values for maximum GIR values were higher for Actrapid than either dose of Capsulin (p < 0.05). The significantly greater systemic insulin concentrations following Actrapid were reflected in the AUC0,6 h (910 ± 270 vs. 472 ± 245 pmol h/L; 950 ± 446 vs. 433 ± 218 pmol h/L; both p < 0.05 for Actrapid vs. 150U Capsulin and 300U Capsulin respectively). No difference was observed between 150U and 300U Capsulin. During the repeat-dosing period, good safety and tolerability were observed with Capsulin, and SMBG levels remained stable. At the poststudy visit, significant falls in HbA1c, weight and triglycerides were observed. Conclusions: Administration of the oral insulin Capsulin preparation demonstrated a significant hypoglycaemic action over a period of 6 h associated with only a small increase in circulating plasma insulin concentrations. [source]

Functional significance of hepatic arterial flow reserve in patients with cirrhosis

HEPATOLOGY, Issue 2 2003
Alexander Zipprich
In cirrhosis, hepatic arterial vasodilatation occurs in response to reduced portal venous blood flow. However, although the hepatic arterial flow reserve is high in patients with cirrhosis, its impact on hepatic function is unknown. This study investigated the effect of adenosine-induced hepatic arterial vasodilatation on different markers of liver function. In 20 patients with cirrhosis (Child-Pugh class A/B/C: n = 2/7/11) adenosine (2-30 ,g · min,1 · kg body wt,1) was infused into the hepatic artery and hepatic arterial average peak flow velocities (APV), pulsatility indices (PI), and blood flow volumes (HABF) were measured using digital angiography and intravascular Doppler sonography. Indocyanine green (ICG), lidocaine, and galactose were administered intravenously in doses of 0.5, 1.0, and 500 mg/kg body weight in the presence of adenosine-induced hepatic arterial vasodilatation and, on a separate study day, without adenosine. ICG disappearance, galactose elimination capacity (GEC), and formation of the lidocaine metabolite monoethylglycinxylidide (MEGX) were assessed. Adenosine markedly increased APV and HABF and markedly decreased PI. Serum MEGX concentrations were 63.7 ± 18.2 (median, 62; range, 36-107) and 99.0 ± 46.3 (82.5; 49-198) ng/mL in the absence and presence of adenosine infusion, respectively (P = .001). Adenosine-induced changes in MEGX concentrations were correlated inversely to changes in APV (r = ,0.5, P = .02) and PI (r = ,0.55, P = .01) and were more marked in Child-Pugh class C compared with Child-Pugh class A patients (57.4 ± 49.9 [44; ,14 to 140] vs. 8.4 ± 16.5 [13; ,11 to 35] ng/mL, P < .01). In conclusion, hepatic arterial vasodilatation provides substantial functional benefit in patients with cirrhosis. The effect does not depend directly on hepatic arterial macroperfusion and is observed preferentially in patients with decompensated disease. [source]

Effects of a 5-HT3 antagonist, ondansetron, on fasting and postprandial small bowel water content assessed by magnetic resonance imaging

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 5 2010
L. Marciani
Aliment Pharmacol Ther 2010; 32: 655,663 Summary Background, 5-HT3 antagonists have been shown to be effective in relieving the symptoms of irritable bowel syndrome with diarrhoea (IBS-D). Using a recently validated magnetic resonance imaging (MRI) method, we have demonstrated reduced fasting small bowel water content (SBWC) in IBS-D associated with accelerated small bowel transit. We hypothesized that slowing of transit with ondansetron would lead to an increase in SBWC by inhibiting fasting motility. Aim, To assess the effects of ondansetron compared with placebo in healthy volunteers on SBWC and motility in two different groups of subjects, one studied using MRI and another using manometry. Methods, Healthy volunteers were given either a placebo or ondansetron on the day prior to and on the study day. Sixteen volunteers underwent baseline fasting and postprandial MRI scans for 270 min. In a second study, a separate group of n = 18 volunteers were intubated and overnight migrating motor complex (MMC) recorded. Baseline MRI scans were carried out after the tube was removed. Results, Fasting SBWC was markedly increased by ondansetron (P < 0.0007). Ondansetron reduced the overall antroduodenal Motility Index (P < 0.04). The subjects who were intubated had significantly lower fasting SBWC (P < 0.0002) compared with the group of subjects who were not intubated. Conclusions, The 5-HT3 receptor antagonism increased fasting small bowel water. This was associated with reduced fasting antroduodenal Motility Index which may explain the clinical benefit of such drugs. [source]

Control of intragastric pH with omeprazole 20 mg, omeprazole 40 mg and lansoprazole 30 mg

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 5 2001
P. O. Katz
Background: Single daily doses of proton pump inhibitors, omeprazole and lansoprazole provide effective acid suppression and equal healing and symptom relief in patients with GERD. Despite this, controversy exists as to the efficacy of available proton pump inhibitors in the control of gastric acidity. Aim: To assess the efficacy of omeprazole 20 mg vs. lansoprazole 30 mg and omeprazole 40 mg vs. lansoprazole 30 mg in intragastric pH control. Methods: Study I: 12 Helicobacter pylori -negative volunteers (mean age 33 years) were treated with omeprazole 20 mg and lansoprazole 30 mg in random order before breakfast for 7 days. Study II: 24 subjects (mean age 36 years) were similarly treated with omeprazole 40 mg and lansoprazole 30 mg for 7 days after a baseline pH study. One week washout was allowed between studies. Subjects had the same meal on each study day. On day seven, a 24-h intragastric pH study was performed. The percentage time for which gastric pH > 4 was analysed (Gastrosoft, Synectics Medical Inc.) and expressed as mean ± s.d. Results: (1) Omeprazole 20 mg and lansoprazole 30 mg showed no significant difference in the percentage time for which gastric pH > 4 in the daytime and night-time periods. (2) The percentage time for which pH > 4 with omeprazole 40 mg was significantly greater than lansoprazole 30 mg in both daytime (61 ± 19% vs. 48 ± 14%, P < 0.001), and night-time periods (34 ± 21% vs. 26 ± 14%, P < 0.05). (3) A large inter-subject variation existed in both studies. (4) In 10 subjects who participated in both studies, omeprazole 40 mg showed a significantly higher percentage time for which pH > 4 in the daytime (69 ± 18% vs. 51 ± 15%, P=0.015) than omeprazole 20 mg. Conclusion: These pH data support the therapeutic equivalency of FDA approved doses of omeprazole and lansoprazole. [source]

Allogeneic retrovirally transduced, IL-2- and IFN-,-secreting cancer cell vaccine in patients with hormone refractory prostate cancer,a phase I clinical trial

THE JOURNAL OF GENE MEDICINE, Issue 7 2007
T. H. Brill
Background The purpose of this vaccine study was to determine the safety and feasibility of vaccination with an allogeneic prostate carcinoma cell line, LNCaP, expressing recombinant interleukin-2 (IL-2) and interferon-, (IFN-,) and to evaluate the efficacy of inducing tumor-specific immune responses in HLA-A2-matched patients with hormone refractory prostate cancer (HRPC). Methods In a dose-escalating phase I study, HLA-A2-matched HRPC patients received four vaccinations of irradiated allogeneic LNCaP cells retrovirally transduced to secrete IL-2 and IFN-, at study day 1, 15, 29 and 92 and subsequently every 91 days unless tumor progression was evident. Results Three patients receiving the first dose level (7.5 million cells) showed no evidence of dose-limiting toxicity or vaccine-related adverse events including autoimmunity. One of three patients receiving the second dose level (15 million cells) developed a transient self-limiting grade 3 local injection site reaction (ulceration) after the eighth vaccination. Vaccine-induced immune responses against a broad array of prostate tumor associated antigens were detected in all six patients. Two of the three patients receiving the higher dose showed a decline in serum prostate-specific antigen (PSA) values of more than 50%, with one patient remaining on protocol for 3 years. Conclusions Immunisation with the allogeneic LNCaP/IL-2/IFN-, vaccine is safe and feasible without any dose-limiting toxicity or autoimmunity. A 50% PSA decline was achieved in two of the six patients. This encouraging data provides the scientific rationale for further investigation of the vaccine in a phase II trial. Copyright © 2007 John Wiley & Sons, Ltd. [source]

Randomized Double-blind Placebo Controlled Crossover Study of Acetaminophen, Ibuprofen, Acetaminophen/Hydrocodone, and Placebo for the Relief of Pain From a Standard Painful Stimulus

ACADEMIC EMERGENCY MEDICINE, Issue 9 2009
James R. Miner MD
Abstract Objectives:, The objective was to compare subjects' change in perceived acute pain from an identical painful stimulus after receiving three separate, commonly used pain medications and placebo. Methods:, This was an institutional review board,approved, randomized, double-blind crossover study of healthy human volunteers. Subjects received 1000 mg of acetaminophen, 800 mg of ibuprofen, the combination of 650 mg of acetaminophen with 10 mg of hydrocodone, or placebo (800 mg of lactose) in a randomized order over four separate occasions each 1 week apart. Prior to receiving the drug on each study day, subjects placed their nondominant hand in a bath of 0°C water for 45 seconds. The bath was divided into two sections; the larger was the reservoir of cooled water monitored at 0°C, and the other half was filled from constant overflow. Water drained from the overflow section into the cooling unit and was then pumped up into the base of the reservoir through a diffusion grid. Subjects completed a 100-mm visual analog scale (VAS) representing perceived pain during the exposure. The cold water exposure and VAS were repeated 1 hour after receiving the study drug, and then subjects were observed for side effects for 4 hours. Data were compared using descriptive statistics, 95% confidence intervals (CIs), and repeated-measures analysis of variance (ANOVA). Results:, Twenty-five subjects were enrolled. The mean VAS preexposure was 56.9 mm (±15.1 mm; range = 5 to 92 mm). The mean decrease in VAS after receiving the study drug for acetaminophen was 10.2% (95% CI = ,1.4 to 20.4), for ibuprofen was ,6.6% (95% CI = ,16.5 to 3.20), for acetaminophen/hydrocodone was 9.5% (95% CI = 1.4 to 20.4), and for placebo was ,6.9% (95% CI = ,15.2 to 1.4). The range in change in pain scores for all agents was ,91.3% to 57.6%. Mild side effects (nausea, dizziness, or somnolence) were reported in 11 subjects (44%) after receiving acetaminophen/hydrocodone; no other side effects were reported. Conclusions:, There was a wide range of changes in pain scores from this identical painful stimulus after receiving the study medications. Acetaminophen and acetaminophen/hydrocodone resulted in a similar decrease in pain (10.2 and 9.5%), while ibuprofen and placebo had a similar lack of effect (,6.6 and ,6.9%). Forty-four percent of subjects receiving acetaminophen/hydrocodone reported mild side effects; no other side effects were seen. In this noninflammatory pain model, the VAS is not able to distinguish differences in pain relief between acetaminophen and acetaminophen/hydrocodone or ibuprofen and placebo. [source]

A study examining inter-rater and intrarater reliability of a novel instrument for assessment of psoriasis: the Copenhagen Psoriasis Severity Index

BRITISH JOURNAL OF DERMATOLOGY, Issue 2 2008
J. Berth-Jones
Summary Background, There is a perceived need for a better method for clinical assessment of the severity of psoriasis vulgaris. The most frequently used system is the Psoriasis Area and Severity Index (PASI), which has significant disadvantages, including the requirement for assessment of the percentage of skin affected, an inability to separate milder cases, and a lack of linearity. The Copenhagen Psoriasis Severity Index (CoPSI) is a novel approach which comprises assessment of three signs: erythema, plaque thickness and scaling, each on a four-point scale (0, none; 1, mild; 2, moderate; 3, severe), at each of 10 sites: face, scalp, upper limbs (excluding hands and wrists), hands and wrists, chest and abdomen, back, buttocks and sacral area, genitalia, lower limbs (excluding feet and ankles), feet and ankles. Objectives, To evaluate the inter-rater and intrarater reliability of the CoPSI and to provide comparative data from the PASI and a Physician's Global Assessment (PGA) used in recent clinical trials on psoriasis vulgaris. Methods, On the day before the study, 14 dermatologists (raters) with an interest in psoriasis participated in a detailed training session and discussion (2·5 h) on use of the scales. On the study day, each rater evaluated 16 adults with chronic plaque psoriasis in the morning and again in the afternoon. Raters were randomly assigned to assess subjects using the scales in a specific sequence, either PGA, CoPSI, PASI or PGA, PASI, CoPSI. Each rater used one sequence in the morning and the other in the afternoon. The primary endpoint was the inter-rater and intrarater reliability as determined by intraclass correlation coefficients (ICCs). Results, All three scales demonstrated ,substantial' (a priori defined as ICC > 80%) intrarater reliability. The inter-rater reliability for each of the CoPSI and PASI was also ,substantial' and for the PGA was ,moderate' (ICC 61%). The CoPSI was better at distinguishing between milder cases. Conclusions, The CoPSI and the PASI both provided reproducible psoriasis severity assessments. In terms of both intrarater and inter-rater reliability values, the CoPSI and the PASI are superior to the PGA. The CoPSI may overcome several of the problems associated with the PASI. In particular, the CoPSI avoids the need to estimate a percentage of skin involved, is able to separate milder cases where the PASI lacks sensitivity, and is also more linear and simpler. The CoPSI also incorporates more meaningful weighting of different anatomical areas. [source]

A study examining inter- and intrarater reliability of three scales for measuring severity of psoriasis: Psoriasis Area and Severity Index, Physician's Global Assessment and Lattice System Physician's Global Assessment

BRITISH JOURNAL OF DERMATOLOGY, Issue 4 2006
J. Berth-Jones
Summary Background, There is a lack of consensus as to the best way of monitoring psoriasis severity in clinical trials. The Psoriasis Area and Severity Index (PASI) is the most frequently used system and the Physician's Global Assessment (PGA) is also often used. However, both instruments have some drawbacks and neither has been fully evaluated in terms of ,validity' and ,reliability' as a psoriasis rating scale. The Lattice System Physician's Global Assessment (LS-PGA) scale has recently been developed to address some disadvantages of the PASI and PGA. Objectives, To evaluate the inter-rater and intrarater reliability of the PASI, PGA and LS-PGA. Methods, On the day before the study, 14 dermatologists (raters), with varied experience of assessing psoriasis, received detailed training (2·5 h) on use of the scales. On the study day, each rater evaluated 16 adults with chronic plaque psoriasis in the morning and again in the afternoon. Raters were randomly assigned to assess subjects using the scales in a specific sequence, either PGA, LS-PGA, PASI or PGA, PASI, LS-PGA. Each rater used one sequence in the morning and the other in the afternoon. The primary endpoint was the inter-rater and intrarater reliability as determined by intraclass correlation coefficients (ICCs). Results, All three scales demonstrated ,substantial' (a priori defined as ICC > 80%) intrarater reliability. The inter-rater reliability for each of the PASI and LS-PGA was also ,substantial' and for the PGA was ,moderate' (ICC 75%). Conclusions, Each one of the three scales provided reproducible psoriasis severity assessments. In terms of both intrarater and inter-rater reliability values, the three scales can be ranked from highest to lowest as follows: PASI, LS-PGA and PGA. [source]

The glucose lowering effect of an oral insulin (Capsulin) during an isoglycaemic clamp study in persons with type 2 diabetes

A randomized trial of the effects of two novel nicotine replacement therapies on tobacco withdrawal symptoms and user satisfaction

ADDICTION, Issue 7 2010
Hayden McRobbie
ABSTRACT Aims To determine effects on craving, user satisfaction, and consumption patterns of two new nicotine replacement therapies (NRT) used for eight hours after overnight tobacco abstinence. Design In a within-subject, cross-over trial participants were randomly assigned Zonnic® nicotine mouth spray (1 mg/spray), Zonnic® nicotine lozenge (2.5 mg), Nicorette® gum (4 mg) and placebo lozenge on each of four study days. Setting University research unit. Participants Forty-seven dependent adult smokers. Measurements Participants rated their urges to smoke, irritability, concentration and restlessness before and during the first hour of product use on a 100-point scale. A subsample of 11 participants provided blood samples for nicotine analysis. Findings All active products reduced craving significantly more than placebo (mean reductions of 28.6, 25.8, 24.7 and 8.9 points for mouth spray, gum, lozenge and placebo). Mouth spray relieved craving faster than placebo and gum with significant reductions within five minutes of use (mean differences of ,14.5 (95% CI: ,23.0 to ,6.0) and ,10.6 (95% CI: ,19.1 to ,2.1) with placebo and gum respectively. Mouth spray produced a faster time to maximum plasma nicotine concentration (14.5 minutes, 95% CI: 8.0 to 21.0) compared to the lozenge (30.3 minutes, 95% CI: 21.1 to 39.5) and gum (45.8 minutes, 95% CI: 36.2 to 55.4). Maximum concentrations of blood nicotine were higher with mouth spray (10.0 ng/ml) and lozenge (10.8 ng/ml) compared to gum (7.8 ng/ml). Both lozenge and mouth spray were well tolerated. Conclusions The mouth spray and lozenge are at least as effective as 4 mg nicotine gum in relieving craving suggesting that they are likely to be effective in aiding smoking cessation. The mouth spray may be particularly useful for acute craving relief. [source]

The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis

EXPERIMENTAL DERMATOLOGY, Issue 1 2001
J. M. Hanifin
Abstract:Objective, To test the reliability of the eczema area and severity index (EASI) scoring system by assessing inter- and intra-observer consistency. Design: Training of evaluators, application, and assessment over 2 consecutive days. Setting, An academic center. Patients, Twenty adults and children with atopic dermatitis (AD); cohort 1 (10 patients ,8 years) and cohort 2 (10 patients <8 years). Interventions, None. Main outcome measure, The EASI was used by 15 dermatologist evaluators to assess atopic dermatitis in cohort 1 and cohort 2 on 2 consecutive days. Inter- and intraobserver reliability were analyzed. Results, Overall intra-evaluator reliability of the EASI was in the fair-to-good range. Inter-evaluator reliability analyses indicated that the evaluators assessed the patients consistently across both study days. Conclusions, This study demonstrated that the EASI can be learned quickly and utilized reliably in the assessment of severity and extent of AD. There was consistency among the evaluators between consecutive days of evaluation. These results support the use of the EASI in clinical trials of therapeutic agents for AD. [source]

Antibiotic lock: In vitro stability of gentamicin and sodium citrate stored in dialysis catheters at 37 °C

HEMODIALYSIS INTERNATIONAL, Issue 3 2010
Marisa BATTISTELLA
Abstract Catheter-related bacteremia (CRB) is a major cause of morbidity and mortality especially among patients receiving hemodialysis. Antibiotic lock therapy represents a promising technique in the treatment of CRB. Several studies have evaluated antibiotics in combination with heparin as an interdialytic locking solution for prophylaxis of CRB. The objective of this study was to evaluate the stability of gentamicin and sodium citrate in hemodialysis catheters as an interdialytic lock. Solutions containing gentamicin 2.5 mg/mL and sodium citrate 40 mg/mL (4%) were prepared individually and in combination. The solutions were instilled into dialysis catheters and stored at 37 °C for 96 h. Samples were withdrawn randomly from catheter lumens at 24-hour intervals for 4 days and stored at ,20 °C until analysis. The samples were analyzed with validated, stability-indicating HPLC assays. The luminal concentration of gentamicin 2.5 mg/mL, sodium citrate 40 mg/mL (4%), and the combination was determined on study days 0, 1, 2, 3, and 4. When gentamicin was combined with sodium citrate and stored at 37 °C in dialysis catheters, the solution showed no decrease in either the gentamicin or the sodium citrate concentrations over the 96-hour study period. The percent of the original concentration at 96 h was 102.4±1.03 for gentamicin and 102.9±1.25 for citrate (P=0.5556). The combination of gentamicin 2.5 mg/mL and sodium citrate 40 mg/mL (4%) can be retained in hemodialysis catheters for at least 96 h at 37 °C with no evidence of degradation. [source]

The impact of pressure ulcer risk assessment on patient outcomes among hospitalised patients

JOURNAL OF CLINICAL NURSING, Issue 13 2009
Mohammad Saleh
Aims and objectives., To determine whether use of a risk assessment scale reduces nosocomial pressure ulcers. Background., There is contradictory evidence concerning the validity of risk assessment scales. The interaction of education, clinical judgement and use of risk assessment scales has not been fully explored. It is not known which of these is most important, nor whether combining them results in better patient care. Design., Pretest,posttest comparison. Methods., A risk assessment scale namely the Braden was implemented in a group of wards after appropriate education and training of staff in addition to mandatory wound care study days. Another group of staff received the same education programme but did not implement the risk assessment scale and a third group carried on with mandatory study days only. Results., Nosocomial Pressure Ulcer was reduced in all three groups, but the group that implemented the risk assessment scale showed no significant additional improvement. Allowing for age, gender, medical speciality, level of risk and other factors did not explain this lack of improvement. Clinical judgement seemed to be used by nurses to identify patients at high risk to implement appropriate risk reduction strategies such as use of pressure relieving beds. Clinical judgement was not significantly different from the risk assessment scale score in terms of risk evaluation. Conclusions., It is questioned whether the routine use of a risk assessment scale is useful in reducing nosocomial pressure ulcer. It is suggested clinical judgement is as effective as a risk assessment scale in terms of assessing risk (though neither show good sensitivity and specificity) and determining appropriate care. Relevance to clinical practice., Clinical judgement may be as effective as employing a risk assessment scale to assess the risk of pressure ulcers. If this were true it would be simpler and release nursing time for other tasks. [source]

Post-operative epidural analgesia: introducing evidence-based guidelines through an education and assessment process

JOURNAL OF CLINICAL NURSING, Issue 2 2001
DipDN, Janet Richardson BSc
,,The aim of this project was to re-introduce post-operative epidural analgesia on to two orthopaedic wards using an evidence-based practice approach. This was achieved through the provision of appropriate staff education and information, assessment of staff competence, and provision of relevant and appropriate staff support. ,,An education programme was developed which included study days, ward-based teaching and the assessment of competence. ,,The introduction of guidelines followed an audit cycle in order to measure the success of the education programme. ,,All nursing staff involved in the project were asked to complete a questionnaire which assessed their knowledge of caring for patients with postoperative epidural analgesia. This was completed before and following the education programme. ,,The outcome measures were: (i) successful completion of competence-based assessment; (ii) levels of knowledge as assessed by the knowledge questionnaire; and (iii) participant perceptions of the project. ,,The results of the questionnaire demonstrated significant improvements in knowledge following the education programme. Participants commented on the importance of the ward-based teaching. They also felt that pain was controlled more effectively using this method of analgesia. [source]

The influence of lithium on the antidiuretic effect of desmopressin

JOURNAL OF PHARMACY AND PHARMACOLOGY: AN INTERNATI ONAL JOURNAL OF PHARMACEUTICAL SCIENCE, Issue 9 2002
Torbjörn Callréus
ABSTRACT The objective of this study was to investigate the graded influence from lithium on the antidiuretic effects of desmopressin. Eight healthy male subjects participated in this open, randomised cross-over study with two periods comprising 6 days each. For each subject, one of the study days (6th day) was preceded by a period of lithium treatment. On the study days the subjects were orally water loaded to achieve a state of overhydration with a high urine flow rate. When a steady-state diuresis was achieved after approximately 2 h, 0.396 ,g of desmopressin was administered intravenously as a bolus injection. An indirect-response model, where desmopressin was assumed to inhibit the elimination of response, was fitted to the urine osmolarity data. The effects of the independent variables, Uflow (baseline) (baseline urine flow rate), R0 (baseline osmolarity) and serum lithium concentration, on IC50 (concentration producing 50% of the maximum inhibition) could be expressed by multiple linear regression. In conclusion, we found that an indirect-response model can be a useful tool in investigating and describing the pharmacodynamic interaction between drugs, in this particular case, between lithium and desmopressin. [source]

Effect of amantadine in essential tremor: A randomized, placebo-controlled trial

MOVEMENT DISORDERS, Issue 4 2006
Alexandre Gironell MD
Abstract There is a need for new medication for essential tremor (ET). Preliminary evidence suggests that amantadine may be effective in the treatment of ET. We studied the effects of amantadine in a double-blind, cross-over, placebo-controlled trial in ET patients. Sixteen patients with ET received amantadine 100 mg b.i.d. and placebo for 15 days, with a 1-week wash-out period between treatments. Major evaluation outcomes consisted of a tremor clinical rating scale, accelerometric recordings, and a self-reported disability scale obtained before drug intake and on study days 1 and 15 of each treatment period. A two-way repeated measures analysis of variance (treatment, time) was applied. Any P value < 0.05 was considered significant. On day 15, amantadine did not demonstrate any significant efficacy in reducing tremor with respect to baseline in any tremor measures. An increase in postural tremor as an adverse effect of amantadine was referred by 37.5% of patients. Results from the present trial indicate amantadine at 100 mg b.i.d. is not effective as a treatment for ET. © 2005 Movement Disorder Society [source]

Optometrists' examination and referral practices for patients presenting with flashes and floaters

OPHTHALMIC AND PHYSIOLOGICAL OPTICS, Issue 3 2002
A. Alwitry
Introduction:,Patients experiencing flashes and floaters commonly present to their optometrist. Some of these patients may have significant pathology, yet there is a great deal of variability with regard to examination technique and referral practice. Methods:,A questionnaire survey was undertaken to determine the current management of patients presenting to their optometrist with flashes and floaters. All practising community optometrists within Southern Derbyshire received a questionnaire and 74 (56.9%) completed replies were received. Results:,Optometrists estimated that an average of 14 patients per month per optometrist presented with symptoms of flashes and/or floaters. Mydriasis was utilised routinely for examination in approximately half of the patients. Mean relative confidence was 2.0 at identifying a vitreous haemorrhage and 6.5 for vitreous pigment (complete confidence = 0, complete lack of confidence = 10). Eight percent of responders were unfamiliar with the clinical sign of vitreous pigment, and 17% identifying this sign did not refer all such patients to the hospital services. Conclusions:,Patients presenting to their optometrists with flashes and/or floaters make up a sizeable part of the community optometrist's workload and the management of these patients is highly variable. A large proportion of these patients are examined without mydriasis, even in the presence of various risk factors for retinal detachment. There is a relative lack of confidence amongst optometrists with regards the detection of vitreous pigment and the prognostic implications of this finding. Educational measures such as study days may help the level of understanding and heighten the appreciation of the implications of flashes and floaters and the various clinical signs encountered. [source]

The rate of urinary cortisol excretion at work is persistently elevated in women at familial risk for breast cancer

AMERICAN JOURNAL OF HUMAN BIOLOGY, Issue 4 2008
Gary D. James
We recently reported that healthy women at familial risk for breast cancer (FH+) have higher urinary cortisol levels at work than women without familial risk (FH,). The purpose of this study was to evaluate whether this group difference persisted over a 1-month period. Subjects were healthy women (FH+, N = 42, age = 37.6 ± 9.3, FH,, N = 93, age 38.4 ± 9.0) employed primarily in clerical or technical positions at three medical centers in New York City who collected timed urine samples in three contrasting daily environments, at work (,11AM,3PM), home (,6PM,10PM) and during sleep (,10PM,6AM) on 2 mid-week workdays ,1 month apart. Two-way repeated measures ANOVA revealed that cortisol excretion differed across the environments (P < 0.001), and that there was also a significant interaction between daily environment and family history group (P < 0.049), such that FH+ women maintained higher cortisol excretion at work over the 2 days than FH, women. A Bland,Altman plot showed that both overall and by family history group, the rate of cortisol excretion at work was generally reproducible, although there was a heteroscadasticity in the relationship that likely reflected excessive stressfulness on one of the study days in a small minority of subjects. These results suggest that the presence of a potent background stressor (familial breast cancer risk) can influence more acute cortisol responses in daily life over time. Am. J. Hum. Biol., 2008. © 2008 Wiley-Liss, Inc. [source]

Influence of endogenous angiotensin II on control of sympathetic nerve activity in human dehydration

THE JOURNAL OF PHYSIOLOGY, Issue 22 2009
J. A. Rabbitts
Arterial blood pressure can often fall too low during dehydration, leading to an increased incidence of orthostatic hypotension and syncope. Systemic sympathoexcitation and increases in volume regulatory hormones such as angiotensin II (AngII) may help to maintain arterial pressure in the face of decreased plasma volume. Our goals in the present study were to quantify muscle sympathetic nerve activity (MSNA) during dehydration (DEH), and to test the hypothesis that endogenous increases in AngII in DEH have a mechanistic role in DEH-associated sympathoexcitation. We studied 17 subjects on two separate study days: DEH induced by 24 h fluid restriction and a euhydrated (EUH) control day. MSNA was measured by microneurography at the peroneal nerve, and arterial blood pressure, electrocardiogram, and central venous pressure were also recorded continuously. Sequential nitroprusside and phenylephrine (modified Oxford test) were used to evaluate baroreflex control of MSNA. Losartan (angiotensin type 1 receptor (AT1) antagonist) was then administered and measurements were repeated. MSNA was elevated during DEH (42 ± 5 vs. EUH: 32 ± 4 bursts per 100 heartbeats, P= 0.02). Blockade of AT1 receptors partially reversed this change in MSNA during DEH while having no effect in the control EUH condition. The sensitivity of baroreflex control of MSNA was unchanged during DEH compared to EUH. We conclude that endogenous increases in AngII during DEH contribute to DEH-associated sympathoexcitation. [source]

Emergency Department Patient Flow: The Influence of Hospital Census Variables on Emergency Department Length of Stay

ACADEMIC EMERGENCY MEDICINE, Issue 7 2009
Ray Lucas MD
Abstract Objectives:, The objective was to evaluate the association between hospital census variables and emergency department (ED) length of stay (LOS). This may give insights into future strategies to relieve ED crowding. Methods:, This multicenter cohort study captured ED LOS and disposition for all ED patients in five hospitals during five 1-week study periods. A stepwise multiple regression analysis was used to examine associations between ED LOS and various hospital census parameters. Results:, Data were analyzed on 27,325 patients on 161 study days. A significant positive relationship was demonstrated between median ED LOS and intensive care unit (ICU) census, cardiac telemetry census, and the percentage of ED patients admitted each day. There was no relationship in this cohort between ED LOS and ED volume, total hospital occupancy rate, or the number of scheduled cardiac or surgical procedures. Conclusions:, In multiple hospital settings, ED LOS is correlated with the number of admissions and census of the higher acuity nursing units, more so than the number of ED patients each day, particularly in larger hospitals with busier EDs. Streamlining ED admissions and improving availability of inpatient critical care beds may reduce ED LOS. [source]

Relative lung and systemic bioavailability of sodium cromoglycate inhaled products using urinary drug excretion post inhalation

BIOPHARMACEUTICS AND DRUG DISPOSITION, Issue 4 2002
Osama Aswania
Abstract The relative lung and systemic bioavailability of sodium cromoglycate following inhalation by different methods have been determined using a urinary excretion pharmacokinetic method. On three separate randomised study days, 7 days apart, subjects inhaled (i) 4×5 mg from an Intal® metered dose inhaler (MDI), (ii) 4×5 mg from an MDI attached to a large volume spacer (MDI+SP) and (iii) 20 mg from an Intal Spinhaler® (DPI). Urine samples were provided at 0, 0.5, 1, 2, 5 and 24 h post dose. The mean (S.D.) amount of sodium cromoglycate excreted in the urine during the first 30 min post inhalation was 38.1 (27.5), 222.3 (120.3) and 133.1 (92.2) ,g following MDI, MDI+SP and DPI, respectively. The mean ratio (90% confidence interval) of these amounts excreted in the urine over the first 30 min for MDI+SP vs MDI, DPI vs MDI and MDI+SP vs DPI was 801.0 (358.0, 1244; p<0.002)%, 457.0 (244.0, 670.0; p<0.02)% and 262.4 (110.2, 414.5)%, respectively. Similarly for the 24 h cumulative amount of sodium cromoglycate excreted over the 24 h post inhalation the ratios were 375.4 (232.9, 517.9; p<0.005)%, 287.5 (183.4, 391.6; p<0.02)% and 211.4 (88.3, 334.5)%, respectively. The results highlight better lung deposition of sodium cromoglycate from a metered dose inhaler attached to a large volume spacer. Copyright © 2002 John Wiley & Sons, Ltd. [source]

The relationship between desmopressin treatment and voiding pattern in children

BJU INTERNATIONAL, Issue 9 2002
G.M. Hvistendahl
Objective,To collate data on voiding patterns at baseline (no treatment) and during short-term desmopressin treatment, with special reference to the functional and the mean bladder capacity. Patients and methods,The study included 120 children (aged 6,16 years) with monosymptomatic nocturnal enuresis. While at home they recorded their fluid intake and diuresis in two separate periods, i.e. 2 weeks as a baseline registration and another 2 weeks during desmopressin titration. On four study days the children recorded the time and volume of all voids and of fluid intake. From the diaries their functional and mean bladder capacities, 24-h diuresis and day/night ratio of diuresis were determined. Results,The mean 24-h diuresis was significantly lower during short-term desmopressin treatment. In most of the enuretics the mean day/night ratio increased on desmopressin treatment. The mean functional and mean bladder capacities were unaffected by desmopressin. Those not responding had bladder capacities of ,,100 mL less than full responders. Regardless of response, practically all the enuretics in the study had a smaller functional bladder capacity than expected for their age. Among responders the morning void was significantly larger than the following voids during the day, and among non-responders the fourth void was significantly larger than the previous voids in the day. Desmopressin treatment did not influence these volumes significantly. Conclusions,Short-term desmopressin treatment does not affect functional and mean bladder capacity; 24-h urine production was reduced significantly (P<0.01) during desmopressin treatment. [source]

Influence of Ginkgo biloba on ocular blood flow

ACTA OPHTHALMOLOGICA, Issue 4 2007
Barbara Wimpissinger
Abstract. Purpose:, To investigate the effect of Ginkgo biloba extract (EGb761) on ocular blood flow. Methods:, This randomized, double-masked, placebo-controlled, two-way crossover study included 15 healthy male volunteers. Measurements were taken with laser Doppler flowmetry, laser Doppler velocimetry, a retinal vessel analyser, laser interferometry and applanation tonometry, before and up to 3 hours after oral intake of 240 mg EGb761. Results:, At baseline, no significant differences in ocular and systemic haemodynamic parameters were observed between the two study days. Ginkgo biloba significantly decreased retinal venous diameters (p < 0.05 versus baseline), but there was no significant difference between the two groups. Blood pressure, retinal arterial and venous diameters, choroidal blood flow, fundus pulsation amplitude, intraocular pressure and retinal blood flow remained unchanged in both groups and did not differ between groups. Optic nerve head blood flow significantly increased in response to Ginkgo biloba (p < 0.002 versus baseline), but this effect was not significant compared with that of placebo. Conclusions:, The results of this study indicate that a single administration of Ginkgo biloba does not influence ocular blood flow to a relevant degree. Whether the drug may influence ocular blood flow in patients with ocular vascular disease after longterm treatment remains to be investigated in a randomized, placebo-controlled clinical trial. [source]