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Study Group

Publications and source records attributed to Study Group.

17 recordsLinked to original sources
PubMed2004

Differential brain and body temperature during cardiopulmonary bypass--a randomised clinical study.

OBJECTIVE: Maintenance of normothermia during cardiopulmonary bypass (CPB) may have advantages over hypothermia but there is a potential increased hazard of neurological injury. A novel aortic cannula (Cobra catheter, Cardeon Corp., Cupertino, CA, USA) which compartmentalises the aorta may allow simultaneous brain cooling during maintained corporeal normothermia. We investigated the thermal efficacy of this technique. METHODS: We randomized 60 adult patients to normothermic CPB (n=30, temp=35 degrees C) or to differential temperature management (Cobra cannula). Nasopharyngeal (NPT) and jugular bulb (JB) temperatures were used as surrogates for brain temperature while bladder temperature (BLT) represented the body (corporeal) temperature. Brain (radial) and corporeal (femoral) mean arterial pressure (MAP) together with jugular bulb and mixed venous saturations were monitored to assess perfusion adequacy. Transcranial Doppler was used to assess high intensity transient signals (HITS). All patients had neuropsychometric assessment pre-operatively and at 1 and 8 weeks post-operatively. RESULTS: Demographic and CPB variables were comparable. A 3.2+/-0.46 degrees C differential between BLT and NPT was reached in all Cobra patients after 5.5+/-3.6 min (P<0.001). A 5 degrees C differential was reached in 29 patients after 12+/-7.5 min. The mean difference was 6.6+/-1 degrees C. MAP was maintained above 50 mmHg and venous saturations above 60% in both groups throughout. Blood requirements, extubation time and ITU stay were no different. Embolic counts and neuropsychometric outcomes were not different between groups. CONCLUSIONS: Differential temperature management using the Cobra aortic catheter is possible. Further studies are necessary to establish whether the hypothesized advantages of combining corporeal normothermia with brain hypothermia can be realised.

Aged↗
PubMed2004

Comparison of two budesonide dry powder inhalers in the treatment of asthma in children.

The aim of this study was to compare the clinical efficacy, safety, and acceptability of budesonide inhaled from Easyhaler dry powder inhaler (DPI) (Giona Easyhaler, Orion Pharma, Finland) and from Turbuhaler DPI (Pulmicort Turbuhaler, AstraZeneca, Sweden) in the treatment of asthma in children. The 6-month, randomised, double-blind, double-dummy, parallel-group study was conducted in 229 completed, asthmatic children (5-10 years), who were symptomatic at study entry. For the first 2 months, children inhaled budesonide 2 x 200 microg b.i.d. (high-dose treatment period). Thereafter, the daily dose of inhaled budesonide was 2 x 100 microg for 4 months (low-dose treatment period). The study was carried out at 32 centers in Finland, Sweden, Norway, and Denmark. During the high-dose treatment period, the initially symptomatic patients improved in both treatment groups and the achieved control was maintained during the low-dose treatment period. An improvement was seen in the efficacy outcome parameters in the initially symptomatic patients in both treatment groups. Also, there were no differences in the number of asthma exacerbations between the treatments. The urinary free cortisol/creatinine (UCC) ratios were significantly lower in the Turbuhaler group compared to the Easyhaler group after the high-dose treatment period. In addition, there was a slight but statistically significant slower growth rate in the Turbuhaler group after the 6- month treatment period compared with the Easyhaler group. Pulmicort Turbuhaler and Giona Easyhaler are equally effective in the treatment of asthma in children aged 5-10 years old. Budesonide inhaled from Turbuhaler showed slightly greater systemic effects than budesonide inhaled from Easyhaler. The majority of children and parents preferred Easyhaler to Turbuhaler.

Asthma↗
PubMed2004

Individualized bicarbonate concentrations in the peritoneal dialysis fluid to optimize acid-base status in CAPD patients.

BACKGROUND: A large percentage of peritoneal dialysis (PD) patients being treated with standard lactate-containing solutions tend to have serum bicarbonate concentrations below or above the normal range. The inter-patient variability of serum bicarbonate is a result of many influences and it may be appropriate to adjust the bicarbonate concentration in the peritoneal dialysis fluid (PDF) to the current serum bicarbonate in the individual patient. METHODS: Two concentrations of bicarbonate in PDF were compared in this study (34 and 39 mmol/l). Eligible patients underwent a pre-study phase of 12 weeks to determine serum bicarbonate every six weeks. Sixty-one patients entered the stratification phase. Acidotic patients (serum venous bicarbonate <25.3 mmol/l) were allocated to the high bicarbonate solution, patients in the normal serum bicarbonate range or alkalotic patients (serum venous bicarbonate >25.3 mmol/l) to the low bicarbonate solution. Patients were followed up for 24 weeks, in which study visits were performed every 6 weeks to assess acid-base status, peritoneal and renal function, and to calculate protein nitrogen appearance rate (PNA). RESULTS: Patients with acidosis at baseline had higher body weight, body surface area, blood urea nitrogen, serum creatinine and PNA than patients with bicarbonate within the normal range or with alkalosis. They significantly improved their serum bicarbonate (23.45 +/- 2.5 vs 25.7 +/- 2.8 mmol/l, baseline vs week 24; P < 0.01), whereas patients treated with the low bicarbonate PDF maintained their serum venous bicarbonate over the 24 week study period (27.77 +/- 2.9 vs 27.06 +/- 2.1 mmol/l, baseline vs week 24; P = NS). Analysing both study groups together, at baseline, 66% of the patients presented with mild to moderate acidosis, this figure at the end of the study was 23.4%. PNA did not change in the two groups; however, in the subgroup of patients (N = 23) in whom the 39 mmol/l PDF was effective in correcting metabolic acidosis, a decrease in PNA was observed. CONCLUSIONS: The study demonstrated that the individualized application of low and high bicarbonate PD PDFs allows one to achieve normal acid-base status in a large percentage of CAPD patients with potential benefits to nutritional status.

Acid-Base Equilibrium↗
PubMed2003

Antibiotic-associated diarrhoea and Clostridium difficile in the community.

BACKGROUND: Clostridium difficile is the main cause of nosocomial infectious diarrhoea and the causative agent of antibiotic-associated colitis. The involvement of C. difficile infection in antibiotic-associated diarrhoea in the community is poorly documented. METHODS: We studied prospectively 266 adult out-patients in the Paris (France) area who were prescribed a 5-10-day course of antimicrobial chemotherapy. Stools were screened for C. difficile before and 14 days after the start of treatment by standard culture, toxigenic culture and testing for the cytopathic effect of toxin B. Patients were requested to note daily stool frequency and consistency. Diarrhoea was defined as the passage of at least three loose stools per day. RESULTS: Forty-six (17.5%) of the 262 assessable patients had diarrhoea during the study period. Diarrhoea was mild and self-limited in all patients, and lasted for only 1 day in 65.6% of cases. C. difficile was isolated before and after treatment from one patient, who did not develop diarrhoea. C. difficile was detected only on day 14 in 10 patients (3.8%). The isolate was toxin producing in seven patients. Four of these seven patients had mild self-limited diarrhoea. Toxin-producing C. difficile was isolated significantly more frequently from patients who had diarrhoea than from those who were diarrhoea free (8.7% vs. 1.4%, P = 0.02). CONCLUSION: The acquisition of toxin-producing C. difficile appears to be frequent during antimicrobial chemotherapy in the community [estimated rate of 2700 (1150-5400) cases per 100 000 exposures to antibiotics]. However, C. difficile is not the main agent of mild antibiotic-associated diarrhoea in out-patients.

Adolescent↗
PubMed2003

Levocetirizine is effective for symptom relief including nasal congestion in adolescent and adult (PAR) sensitized to house dust mites.

BACKGROUND: Antihistamines are the most commonly prescribed class of medication for perennial allergic rhinitis (PAR). The primary objective of this study was to determine whether levocetirizine (Xyzal(R)), the active enantiomer of cetirizine, could achieve at least a 50% improvement in PAR symptoms compared to the placebo over the first week of treatment. METHODS: A total of 294 patients with PAR due to house dust mites were randomized in this 8-week double-blind, placebo-controlled, multicentre trial to receive either levocetirizine 5 mg/day or placebo. Mean Total Four-Symptom Scores (T4SS) (nasal pruritus, ocular pruritus, rhinorrhoea and sneezing) were compared between treatment groups over weeks 1, 4 and 6. All individual symptom scores, including nasal congestion, were also studied. RESULTS: Levocetirizine showed an 86% improvement in T4SS over the first week of treatment and a 47% improvement over the entire treatment period compared with placebo. Absolute changes from baseline were 3.64 and 2.47 for levocetirizine and placebo, respectively. Individual symptom scores showed statistically significant (P < or = 0.01) differences in favour of levocetirizine for all study time-points. Nasal congestion was unexpectedly significantly improved (P < 0.001). The incidence of reported adverse events was comparable between treatment and placebo group. CONCLUSIONS: Levocetirizine 5 mg/day is an effective and well-tolerated treatment of PAR. In addition, levocetirizine is effective for the relief of nasal congestion.

Adolescent↗
PubMed2003

Clinical experience with an automatic threshold tracking algorithm study.

The automatic threshold tracking pacing system algorithm developed by St. Jude Medical, verifies ventricular capture beat by beat by recognizing the evoked response (ER) following each pacemaker stimulus. The present automatic threshold tracking function requires a bipolar ventricular lead with low polarization. The aim of this study was to evaluate a new algorithm developed to use with unipolar leads with different levels of polarization. An external pacemaker with the ability to sense intrinsic R waves and measure ER signals, as well as deliver stimulus, was used. An algorithm for detecting the true ER in a unipolar sensing configuration (tip-case) was developed. Based on the assumption that the true evoked R wave amplitude is independent of the stimulation amplitude, the algorithm calculates and subtracts the polarization present at any pacing stimulus from the measured ER. The resulting signal is analyzed to verify capture. This study comprises 35 patients of which 26 were new implants and 9 had chronic leads. The automatic threshold-tracking algorithm was calibrated for each patient and pacing was performed at different pulse amplitudes and pulse duration. Capture was verified for each paced beat. The recordings were stored for later comparison with the tape-recorded intracardiac heart signals. The new algorithm correctly verified capture or loss of capture for every single analyzed beat at the different pacing outputs in every individual patient. The results from this initial study suggests that the new ER detection principle will allow automatic threshold tracking to be used not only with low polarization bipolar leads but with most leads.

Aged↗
PubMed2002

In vitro activity of moxifloxacin against recent community-acquired respiratory tract pathogens isolated in France: a national survey.

Between February and June 2000, 2345 consecutive strains of Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus and Klebsiella pneumoniae were isolated from 2088 adult patients suffering from community-acquired respiratory tract infections, in 97 hospital laboratories. Of the 1037 S. pneumoniae isolates, 48.3% were intermediately or highly penicillin resistant. For invasive isolates, the MIC90s of penicillin G, amoxycillin, cefuroxime, ceftriaxone, erythromycin, ofloxacin, ciprofloxacin and moxifloxacin were 2, 2, 4, 0.5, 1024, 2, 2 and 0.25 mg/l, respectively. All but one invasive strain were susceptible to moxifloxacin whereas 97.5% were susceptible to levofloxacin. The MIC90s of clinical isolates with intermediate susceptibility or high resistance to penicillin G, were 2, 2, 4, 1, 1024, 2, 2 and 0.25 mg/l. About 98.1, 97.0, and 83.1% of strains were inhibited by concentrations < or = 1 mg/l of moxifloxacin, levofloxacin and ciprofloxacin, respectively (E-test). Eight of the 1037 S. pneumoniae strains were not susceptible to moxifloxacin and had mutations in gyrA (eight strains), parC (four strains) or parE (three strains). Against H. influenzae (32.7% were beta-lactamase producers) and M. catarrhalis (96.3% were beta-lactamase producers), the MIC90s of moxifloxacin, amoxycillin and co-amoxiclav were 0.094 and 0.125 mg/l, 64 and 8 mg/l, and 1.5 and 0.25 mg/l, respectively. Against oxacillin-susceptible S. aureus and K. pneumoniae, the MIC90s of moxifloxacin were 0.125 and 0.84 mg/l respectively. Moxifloxacin had the highest in vitro activity of all antibiotics tested.

Adolescent↗
PubMed2002

Prescribing second-generation antipsychotics and the evolving standard of care in Italy.

The present study was carried out to investigate the routine use of second-generation antipsychotic drugs in the Italian psychiatric care system. Seven outpatient psychiatric services enrolled a consecutive case series of patients who were being treated, or had started treatment, with clozapine, olanzapine, risperidone, or quetiapine. Information on sociodemographic and clinical variables, current psychotropic drug use, side-effects and past use of typical drugs was collected. In addition, patient symptoms and functional status were evaluated by the Health of the Nation Outcome Scale. Patients receiving off-label prescribing of second-generation antipsychotics were identified. A total of 209 patients were collected. In comparison with patients receiving other second-generation antipsychotics, living in residential facilities, unemployment, long psychiatric histories, and problems with activities of daily living and living conditions were more common in clozapine-treated patients. Nearly 80 % of patients receiving clozapine had schizophrenia compared to less than 50 % of those receiving other second-generation antipsychotics. Overall, 109 patients (52 %) received off-label prescriptions of second-generation antipsychotic drugs. This survey indicates that clozapine was mostly reserved for severe cases and poor responders; the high rate of off-label prescriptions highlights the gap existing between recommendations derived from randomised clinical trials and the current use of drugs.

Adolescent↗
PubMed2002

Surveillance of antimicrobial resistance in gram-negative isolates from intensive care units in Turkey: analysis of data from the last 5 years.

A multicenter antimicrobial surveillance program was established in Turkey in 1995 to monitor the predominant Gram-negative pathogens from intensive care units (ICUs) and antimicrobial resistance patterns of these isolates. Sixteen hospitals participated in the study and a total of 1479 isolates from 1,100 patients were collected. The isolates were tested for their susceptibility against 13 antibiotics by E-test method. Minimum inhibitory concentrations (MICs) for each isolate were determined for imipenem, ceftazidime, ceftazidime-clavulanate, cefoperazone-sulbactam, ceftriaxone, cefepime, cefuroxime, piperacillin-tazobactam, ticarcillin-clavulanate, gentamicin, amikacin and ciprofloxacin. The most common isolates were Pseudomonas spp. (28.2%), Escherichia coli (19.2%) and Klebsiella spp. (19.1%). We found very high resistance rates to all major antibiotics that are used to treat serious infections. Although imipenem is the most active agent, it had an overall susceptibility rate of 68%. Half of the tested Klebsiella spp. strains were found to produce ESBL. This is a very high rate when compared with the literature. Cross-resistance among species was also investigated. 52% of ciprofloxacin-resistant strains were also resistant to imipenem, 80% to ceftazidime, 97% to ceftriaxone, 86% to amikacin and 19% of imipenem-resistant strains were susceptible to ceftazidime and 18% to amikacin. When susceptibilities of the years 1995 and 1999 were compared, the most interesting finding was the decrease in resistance to 3rd generation cephalosporins. In conclusion, this national clinical isolate database shows that resistance rates are high, the change over years is not predictable and continuous surveillance is necessary to monitor antimicrobial resistance and to guide antibacterial therapy.

Anti-Bacterial Agents↗
PubMed2001

Prophylaxis failure is associated with a specific Pneumocystis carinii genotype.

To investigate the possible association between Pneumocystis carinii types and various clinical and demographic parameters, we used molecular typing to analyze 93 bronchoalveolar lavage specimens from patients with P. carinii pneumonia (PCP). Multivariate regression analysis revealed an association between being infected with a specific P. carinii genotype and receiving anti-PCP prophylaxis (odds ratio, 4.4; 95% confidence interval, 1.0-18.6; P=.05), although no association with a specific drug was detected.

Adult↗
PubMed2001

EPEC, EAEC and STEC in stool specimens: prevalence and molecular epidemiology of isolates.

Stool specimens of Finns (n = 695) with (n = 603) and without (n = 92) diarrhea were studied for enteropathogenic (EPEC), enteroaggregative (EAEC) and Shiga toxin-producing (STEC) Escherichia coli by PCR. The specific isolates were subsequently investigated for their O:H serotypes and were genotyped by pulsed-field gel electrophoresis (PFGE). A subset (n = 506) of the diarrheal and all non-diarrheal specimens were also searched for conventional enteric bacterial pathogens by standard methods. Diarrheagenic E. coli were found in 5.5% and other enteric pathogens in 6.7% of the patients with and in 2.2% and 1.1% of the subjects without diarrhea, respectively. Campylobacter (3.8%), EPEC (3.2%) and Salmonella (2.0%) were the most common findings, and were detected in diarrheal patients only. STEC were associated with bloody diarrhea (8/9 isolates), whereas EAEC were equally common (1%) in diarrheal and non-diarrheal subjects. Great genomial heterogeneity was seen among diarrheagenic E. coli, and only one EPEC isolate belonged to the "classic" EPEC serogroup (O55).

Adult↗
PubMed2001

The efficacy and safety of sc alniditan vs. sc sumatriptan in the acute treatment of migraine: a randomized, double-blind, placebo-controlled trial.

This double-blind, placebo-controlled, parallel-group, multicentre, multinational, phase-III trial was designed to assess the efficacy and safety of a single subcutaneous injection of placebo, 2 doses of alniditan (1.4 mg and 1.8 mg) and 6 mg of sumatriptan in subjects with acute migraine. A total of 114 investigators from 13 different countries screened 2021 subjects. In total 924 patients were treated with placebo (157), alniditan 1.4 mg (309), alniditan 1.8 mg (141) and sumatriptan 6 mg (317). The lower number of subjects in the alniditan 1.8 mg group is due to the termination of this trial arm after the incidence of a serious adverse event and a subsequent protocol amendment. The number of subjects who were pain free at 2 h (primary endpoint) was: 22 (14.1%) with placebo, 174 (56.3%) with alniditan 1.4 mg, 87 (61.7%) with alnditan 1.8 mg and 209 (65.9%) with sumatriptan 6 mg. Alniditan 1.4 mg was significantly better (P < 0.001) than placebo and sumatriptan was significantly better (P = 0.015) than alniditan 1.4 mg. The number of responders (reduction of headache severity from moderate or severe headache before treatment to mild or absent at 2 h), was 59 (37.8%) on placebo, 250 (80.9%) on alniditan 1.4 mg, 120 (85.1%) on alniditan 1.8 mg, and 276 (87.1%) on sumatriptan. Response was significantly higher (P < 0.001) with alniditan 1.4 mg than with placebo, and significantly lower (P = 0.036) with alniditan 1.4 mg than with sumatriptan. Recurrence rates were: 22 (37.3%) with placebo, 87 (34.8%) with alniditan 1.4 mg, 35 (29.2%) with alniditan 1.8 mg and 108 (39.1%) with sumatriptan. Adverse events occurred in 577/924 (62.4%) subjects, i.e. in 62/157 (39.5%) with placebo, 214/309 (69.3%) with alniditan 1.4 mg, 91/141 (64.5%) with alniditan 1.8 mg and 210/317 (66.2%) with sumatriptan 6 mg. Sumatriptan was significantly better than alniditan 1.4 mg for pain free at 2 h. The difference, however, was small and clinically not important. For alniditan, a dose-dependent adverse event relationship was seen. The safety profile of alniditan 1.4 mg was similar to that of sumatriptan.

Acute Disease↗
PubMed2001

A comparative study of oral acetylsalicyclic acid and metoprolol for the prophylactic treatment of migraine. A randomized, controlled, double-blind, parallel group phase III study.

This study was a multinational, multicentre, double-blind, active controlled phase III trial designed to investigate efficacy and safety of 300 mg acetylsalicyclic acid (ASA) (n = 135) vs. 200 mg metoprolol (n = 135) in the prophylaxis of migraine. In total 270 (51 male and 219 female) patients, aged 18-65 years, suffering between two and six migraine attacks per month were recruited. The main objective was to show equivalence with respect to efficacy, defined as a 50% reduction in the rate of migraine attacks. A run-in phase was carried out with placebo for 4 weeks, followed by a 16-week drug phase. In both treatment groups the median frequency of migraine attacks improved during the study period, from three to two in the ASA group and from three to one in the metoprolol group; 45.2% of all metoprolol patients were responders compared with 29.6% with ASA. Medication-related adverse events were less frequent in the ASA group (37) than in the metoprolol group (73). The findings from this trial show that metoprolol is superior to ASA for migraine prophylaxis but has more side-effects. Acetylsalicylic acid is better tolerated than metoprolol. Using a strict responder criterion ASA showed a responder rate comparable with the placebo rate in the literature.

Adolescent↗
PubMed2001

Treatment of migraine attacks with intranasal alniditan: an open study.

In this open phase-II clinical tolerability trial 17 neurologists enrolled a total of 112 patients and instructed them to administer a maximum of two doses of intranasal alniditan, a 5-HT1B/D receptor agonist, for the treatment of three consecutive migraine attacks of moderate to severe intensity. A second dose of the trial medication was allowed within 1-24 h after the first administration. At 1 h after intranasal administration, 70/103 (68%) patients had responded to treatment (reduction from severe or moderate headache before treatment to mild or no headache) after their first migraine attack, 65/94 (69%) after their second and 52/75 (71%) after their third. In 187/270 (69%) of all attacks, patients were considered responders at 1 h. The median time to onset of effect was 30 min. The migraine headache recurred in 44% (attack 1), 55% (attack 2) and 44% (attack 3) after 4-5 h. Sixty-eight per cent of the patients reported nasal irritation, 19% taste disturbance and 44% throat irritation. Alniditan 2 mg, administered via the intranasal route, was effective in relieving migraine headaches in over two-thirds of the patients at 1 h.

Administration, Intranasal↗
PubMed2001

Infections of the central nervous system of suspected viral origin: a collaborative study from Finland.

We studied 3231 patients with acute central nervous system (CNS) symptoms of suspected viral origin to elucidate the current etiologic spectrum. In 46% of the cases, a viral finding was observed. Varicella-zoster virus (VZV) was the main agent associated with encephalitis, as well as meningitis and myelitis. VZV comprised 29% of all confirmed or probable etiologic agents. Herpes simplex virus (HSV) and enteroviruses accounted 11% each, and influenza A virus 7%. VZV seems to have achieved a major role in viral infections of CNS. In encephalitis in our population, VZV is clearly more commonly associated with these neurological diseases than HSV. The increase in VZV findings may in part be a pseudophenomenon due to improved diagnostic methods, however, a true increase may have occurred and the pathogenetic mechanisms behind this should be elucidated.

Adenoviridae Infections↗
PubMed2000

Enterovirus surveillance of Italian healthy children.

Surveillance of acute flaccid paralysis (AFP) is the golden strategy recommended by the WHO to verify the condition of polio eradication in a country. Because of the difficulty to detect all of the expected AFP cases and to reach the target incidence of 1/100,000 requested by WHO, the surveillance of enteroviruses in the population has been adopted by several countries as an important additional method to verify the absence of wild-poliovirus circulation. To complete the results of AFP surveillance set up in Italy in 1996, we have conducted a wild poliovirus surveillance by examining stool samples from 1551 healthy children aged less than 5 years, collected during the period January 1997 to January 1998. The children were from three cities (Parma, Rome and Bari) located in northern, central and southern Italy. Thirty-nine polioviruses, 72 non-polio enteroviruses and 50 enteric, nonentero (NE), viruses were isolated from stool specimens. Polioviruses identified were nine type 1, seven type 2 and twenty-three type 3. Characterization of isolates by both antigenic and molecular methods showed that all polioviruses were of vaccine origin. As expected, most polioviruses, especially types 2 and 3, presented retromutations known to be associated with loss of the Sabin attenuated phenotype. The results of this study support the data obtained from the active AFP surveillance conducted in Italy in the same period--on the absence of paralytic disease due to wild poliovirus--and altogether demonstrate the effectiveness of the vaccination program.

Child↗