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Clinical Control (clinical + control)
Selected AbstractsAn adaptive clinical Type 1 diabetes control protocol to optimize conventional self-monitoring blood glucose and multiple daily-injection therapyINTERNATIONAL JOURNAL OF ADAPTIVE CONTROL AND SIGNAL PROCESSING, Issue 5 2009Xing-Wei Wong Abstract The objective of this study was to develop a safe, robust and effective protocol for the clinical control of Type 1 diabetes using conventional self-monitoring blood glucose (SMBG) measurements, and multiple daily injection (MDI) with insulin analogues. A virtual patient method is used to develop an in silico simulation tool for Type 1 diabetes using data from a Type 1 diabetes patient cohort (n=40) . The tool is used to test two prandial insulin protocols, an adaptive protocol (AC) and a conventional intensive insulin therapy (IIT) protocol (CC) against results from a representative control cohort as a function of SMBG frequency. With the prandial protocols, optimal and suboptimal basal insulin replacement using a clinically validated, forced-titration regimen is also evaluated. A Monte Carlo (MC) analysis using variability and error distributions derived from the clinical and physiological literature is used to test efficacy and robustness. MC analysis is performed for over 1 400 000 simulated patient hours. All results are compared with control data from which the virtual patients were derived. In conditions of suboptimal basal insulin replacement, the AC protocol significantly decreases HbA1c for SMBG frequencies ,6/day compared with controls and the CC protocol. With optimal basal insulin, mild and severe hypoglycaemia is reduced by 86,100% over controls for all SMBG frequencies. Control with the CC protocol and suboptimal basal insulin replacement saturates at an SMBG frequency of 6/day. The forced-titration regimen requires a minimum SMBG frequency of 6/day to prevent increased hypoglycaemia. Overaggressive basal dose titration with the CC protocol at lower SMBG frequencies is likely caused by uncorrected postprandial hyperglycaemia from the previous night. From the MC analysis, a defined peak in control is achieved at an SMBG frequency of 8/day. However, 90% of the cohort meets American Diabetes Association recommended HbA1c with just 2 measurements a day. A further 7.5% requires 4 measurements a day and only 2.5% (1 patient) required 6 measurements a day. In safety, the AC protocol is the most robust to applied MC error. Over all SMBG frequencies, the median for severe hypoglycaemia increases from 0 to 0.12% and for mild hypoglycaemia by 0,5.19% compared with the unrealistic no error simulation. While statistically significant, these figures are still very low and the distributions are well below those of the controls group. An adaptive control protocol for Type 1 diabetes is tested in silico under conditions of realistic variability and error. The adaptive (AC) protocol is effective and safe compared with conventional IIT (CC) and controls. As the fear of hypoglycaemia is a large psychological barrier to appropriate glycaemic control, adaptive model-based protocols may represent the next evolution of IIT to deliver increased glycaemic control with increased safety over conventional methods, while still utilizing the most commonly used forms of intervention (SMBG and MDI). The use of MC methods to evaluate them provides a relevant robustness test that is not considered in the no error analyses of most other studies. Copyright © 2008 John Wiley & Sons, Ltd. [source] A comparison of budesonide/formoterol maintenance and reliever therapy vs. conventional best practice in asthma managementINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 10 2009R. Louis Summary Objective:, To study the effectiveness and safety of budesonide/formoterol (Symbicort®) Maintenance And Reliever Therapy (Symbicort SMART®, AstraZeneca, Södertalje, Sweden), a simplified management approach with one inhaler compared with conventional best practice (CBP) with multiple inhalers in patients with persistent asthma. Design:, Open-label randomised controlled parallel group trial, 6-month treatment. Participants:, A total of 908 patients , 12 years of age, with persistent asthma receiving treatment with inhaled corticosteroids (ICS), either alone or in conjunction with long-acting ,2 -agonist. Main outcome measures:, Time to first severe asthma exacerbation and number of severe asthma exacerbations. Results:, No difference between groups was seen in time to first severe exacerbation (p = 0.75). Exacerbation rates were low in both groups. A total of 12 patients in the Symbicort SMART® group experienced a total of 14 severe asthma exacerbations, and 19 patients in the CBP group experienced a total of 25 severe asthma exacerbations (annual rate 0.07 vs. 0.13 p = 0.09). The mean daily dose of ICS expressed in BDP equivalent was significantly lower in the Symbicort SMART® group (including as-needed use) vs. in the CBP group (749 ,g vs. 1059 ,g; p < 0.0001). Mean scores in Asthma Control Questionnaire, 5 question version improved significantly in the SMART group compared with the CBP group (p = 0.0026). Symbicort SMART and CBP were equally well tolerated. The mean drug cost/patient/month was significantly lower for the patients in the Symbicort SMART group compared with patients receiving CBP (51.3 , vs. 66.5 ,; p < 0.0001). Conclusions:, In Belgian patients, a simplified regimen using budesonide/formoterol maintenance and reliever therapy was at least as effective at improving clinical control compared with CBP with a significantly lower ICS dose and significantly lower drug costs. [source] Neodymium-YAG Laser for hemangiomas and vascular malformations , long term resultsJOURNAL DER DEUTSCHEN DERMATOLOGISCHEN GESELLSCHAFT, Issue 6 2005Die Behandlung von Hämangiomen und vaskulären Fehlbildungen mit dem Neodymium-YAG-Laser, Langzeitergebnisse Hämangiom; Lasertherapie; Nd:YAG-Laser; vaskuläre Malformation Summary Background: Hemangiomas and vascular malformations are the most common vascular lesions of infancy. Different lasers can be used for treatment. Nd:YAG laser photocoagulation is particularly effective because of its deep penetration into tissue. Patients and methods: Thirty-one patients, aged from three months to 18,years, with voluminous hemangiomas and venous malformations were treated with a cw-neodymium:YAG laser. The quartz fibre was used in percutaneous and intralesional technique. Long-term follow-up data were acquired by clinical control or a patient questionnaire for a maximal period of eight years. Twenty patients could be evaluated. Results: In the group with hemangiomas (n,=,15), three cases showed nearly complete remission (> 90 %), ten cases had a partial reduction in size (50,,,90 %), in one case there was stable disease and in one case tumor growth. In the group with venous malformations (n,=,5) two cases showed an excellent response (> 90 %), one case a moderate response (25,,,50 %) and in two cases there was no improvement. Adverse effects included scars (40 %), hyper- and hypopigmentation (23 %), mild atrophy (20 %) and a wrinkled texture (17 %). After maximal reduction in size, 30 % of the patients were not satisfied with the laser treatment outcome and elected surgical excision of the residual lesion. Conclusions: The neodymium:yttrium aluminium garnet (Nd:YAG) laser with percutaneous or intralesional application technique is a valuable tool for selected patients with hemangiomas and venous malformations. Zusammenfassung Hintergrund: Hämangiome und vaskuläre Malformationen sind die häufigsten Gefäßfehlbildungen in der Kindheit. Eine Therapieoption stellt die Laserbehandlung dar. Der Nd:YAG-Laser ist besonders effektiv aufgrund seiner hohen Eindringtiefe ins Gewebe. Patienten und Methodik: Insgesamt wurden 31,Patienten im Alter zwischen drei Monaten und achtzehn Jahren mit voluminösen Hämangiomen und venösen Malformationen mit einem cw-Neodymium:YAG-Laser behandelt. Die Laserfaser wurde in perkutaner und intraläsionaler Technik angewendet. Die Nachbeobachtung über einen Zeitraum von maximal acht Jahren erfolgte mittels klinischer Kontrollen oder einem Patientenfragebogen. Von den insgesamt 31,Patienten konnten 20 ausgewertet werden. Ergebnisse: In der Gruppe der Patienten mit Hämangiomen zeigten drei Patienten eine fast vollständige Rückbildung (> 90 %), zehn Patienten eine partielle Rückbildung (50,,,90 %), in einem Fall zeigte sich ein unveränderter Befund und bei einem Patienten beobachteten wir weiterhin Wachstum. In der Gruppe der Patienten mit venösen Malformationen zeigten zwei Patienten ein exzellentes Ansprechen (> 90 %), ein Patient ein moderates Ansprechen (25,,,50 %) und bei zwei Patienten kam es zu keiner Verbesserung. Nebenwirkungen beinhalteten Narben (40 %), Hyper- und Hypopigmentierungen (23 %), geringe Atrophie (20 %) und eine Hautfältelung. Nach vollständiger Rückbildung waren 30 % der Patienten unzufrieden mit dem Ergebnis und unterzogen sich einer operativen Entfernung der Residuen. Schlußfolgerungen: Der Nd:YAG-Laser mit perkutaner und intraläsionaler Applikationstechnik stellt eine wirksame Methode zur Behandlung ausgewählter Patienten mit Hämangiomen und venösen Malformationen dar. [source] Comparison of ADHD symptom subtypes as source-specific syndromesTHE JOURNAL OF CHILD PSYCHOLOGY AND PSYCHIATRY AND ALLIED DISCIPLINES, Issue 6 2004Kenneth D. Gadow Background:, This study examines differences between the three subtypes of attention-deficit/hyperactivity disorder (ADHD), inattentive (I), hyperactive-impulsive (H), and combined (C), in a heterogeneous sample of 248 boys (ages 6 to 10 years) with emotional and behavioral problems who were recruited for participation in a diagnostic study. Method:, The boys and their mothers participated in an extensive evaluation that involved multiple assessments of cognitive, behavioral, academic, and family functioning. ADHD subtypes were defined on the basis of teacher alone, mother alone, and mother/teacher ratings of DSM-IV symptoms. Results:, Results indicated ADHD symptom groups showed a differential pattern of impairment socially (H,C>I) and cognitively (I,C>H). The C and H groups were the most and least impaired overall, respectively, and all subtypes were differentiated from the nonADHD clinical control or NONE (N) group in a manner consistent with the primary findings. External validation of group differences was limited, and there were marked inconsistencies in the pattern of findings depending on how groups were defined. For the most part, although the mother/teacher grouping strategy (compared with either alone) captured a greater diversity of differences between subtypes, it also obscured some. Conclusions:, Observed findings are consistent with the notion that mothers and teachers interpret symptom statements in terms of behaviors that are most relevant for their daily concerns. [source] Epitope-specific immunotherapy of rheumatoid arthritis: Clinical responsiveness occurs with immune deviation and relies on the expression of a cluster of molecules associated with T cell tolerance in a double-blind, placebo-controlled, pilot phase II trial,ARTHRITIS & RHEUMATISM, Issue 11 2009Eva C. Koffeman Objective Induction of immune tolerance to maintain clinical control with a minimal drug regimen is a current research focus in rheumatoid arthritis (RA). Accordingly, we are developing a tolerization approach to dnaJP1, a peptide part of a pathogenic mechanism that contributes to autoimmune inflammation in RA. We undertook this study to test 2 hypotheses: 1) that mucosal induction of immune tolerance to dnaJP1 would lead to a qualitative change from a proinflammatory phenotype to a more tolerogenic functional phenotype, and 2) that immune deviation of responses to an inflammatory epitope might translate into clinical improvement. Methods One hundred sixty patients with active RA and with immunologic reactivity to dnaJP1 were enrolled in a pilot phase II trial. They received oral doses of 25 mg of dnaJP1 or placebo daily for 6 months. Results The dnaJP1 peptide was safe and well-tolerated. In response to treatment with dnaJP1, there was a significant reduction in the percentage of T cells producing tumor necrosis factor , and a corresponding trend toward an increased percentage of T cells producing interleukin-10. Coexpression of a cluster of molecules (programmed death 1 and its ligands) associated with T cell regulation was also found to be a prerequisite for successful tolerization in clinical responders. Analysis of the primary efficacy end point (meeting the American College of Rheumatology 20% improvement criteria at least once on day 112, 140, or 168) showed a difference between treatment groups that became significant in post hoc analysis using generalized estimating equations. Differences in clinical responses were also found between treatment groups on day 140 and at followup. Post hoc analysis showed that the combination of dnaJP1 and hydroxychloroquine (HCQ) was superior to the combination of HCQ and placebo. Conclusion Tolerization to dnaJP1 leads to immune deviation and a trend toward clinical efficacy. Susceptibility to treatment relies on the coexpression of molecules that can down-regulate adaptive immunity. [source] Ultrasound of peripheral nerves in acromegaly: changes at 1-year follow-upCLINICAL ENDOCRINOLOGY, Issue 2 2009Eugenia Resmini Summary Context, We have previously demonstrated peripheral nerve enlargement in acromegaly. Objective, The aim of this study was to use ultrasound (US) to assess any changes in the peripheral nerves of patients with acromegaly 1 year after the first evaluation. Patients, We prospectively examined the median and ulnar nerve cross-sectional area (CSA) in 34 non-diabetic, patients with acromegaly (18 females and 16 males; 18,79 years) and 34 age-, sex-, BMI-matched controls, using a 17,5 MHz US probe. Intervention, The median nerve was examined at the mid-forearm (MN-f) and at the carpal tunnel (MN-Ct) levels; the ulnar nerve at mid-forearm (UN-f) and at distal arm (UN-a). Patients were grouped according to the clinical control of the disease: ,improved'; ,always controlled'; ,always uncontrolled'; and ,worsened'. Results, The median nerve at mid-forearm (MN-f), the ulnar nerve at mid-forearm (UN-f) and at distal arm (UN-a) were significantly reduced after 1-year follow-up in all patients (P < 0·001, P < 0·008, P < 0·012, respectively). In the ,improved' group, there was a significant reduction of median nerve CSA examined at mid-forearm (MN-f) (P = 0·02), and distal arm ulnar nerve CSA (UN-a) (P = 0·002). In the other groups no statistically significant differences in ultrasound parameters were recorded. However, UN-a, UN-f, MN-f, MN-ct were still significantly higher in all groups compared with controls (P < 0·001). Conclusion, These data demonstrate that median and ulnar nerves CSA are reduced after 1 year follow-up, in line with the reduction of GH/IGF-I levels. However, as the control of the disease incompletely reverts nerve enlargement, this phenomenon could be only partially reversible. [source] Profiles of the parents of adolescent CSA perpetrators attending a voluntary outpatient treatment programme in IrelandCHILD ABUSE REVIEW, Issue 1 2003Yvonne Duane Abstract A group of 22 parents of adolescent sexual offenders (PASO) was compared with a group of 19 normal controls (NC) and 10 clinical controls (CC) on demographic, developmental, personal adjustment and family environment variables. The assessment protocol included the General Health Questionnaire-12, the Culture-Free Self-Esteem Inventory, the Child Behaviour Checklist, the Family Assessment Device, the Parent Satisfaction Scale and the Multidimensional Scale of Perceived Social Support. Compared with clinical and normal controls, more parents in the PASO group reported that they had been arrested or charged for a criminal offence; had personally experienced child abuse; and more of their adolescents had experienced child abuse, with emotional abuse being the most common form of abuse for both parents and adolescents. Compared with clinical and normal controls, more adolescents of parents in the PASO group had witnessed parental drug or alcohol abuse and had been placed in care outside their home. While parents in the PASO group did not differ from clinical or normal controls in terms of personal adjustment, their adolescents had significantly more internalizing behaviour problems than normal controls, whereas adolescents of parents in the clinical control group had significantly more externalizing behaviour problems than normal controls. Compared with normal controls, parents in both the PASO and clinical control groups reported more difficulties with general family functioning, roles, affective responsiveness, affective involvement and behaviour control and lower levels of parental satisfaction. However, the groups did not differ significantly in their levels of perceived social support. Copyright © 2003 John Wiley & Sons, Ltd. [source] Validity and clinical feasibility of the ADHD rating scale (ADHD-RS) A Danish Nationwide Multicenter StudyACTA PAEDIATRICA, Issue 2 2009N Szomlaiski Abstract Aim: To establish the validity of a Danish version of the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS), secondly to present national norm scores compared to that of United States and other European data and thirdly to evaluate ADHD-RS when used for monitoring treatment effectiveness. Methods: A Danish translation of the ADHD-RS was used on a normative sample of 837 children. Two clinical samples, 138 hyperkinetic disorder (HKD) cases and 110 clinical controls were recruited from eleven Danish Child and Adolescent Mental Health (CAMH) centres and assessed according to usual clinical standards. The HKD children were rated by parents and teachers at baseline and at follow-up 3 months later. Results: Internal validity of ADHD-RS was high and the factor structure supported the diagnostic classification system ICD-10. The questionnaire discriminated HKD patients in a mixed clinical sample, and was sensitive to change in symptom load as measured before and after commencing of the treatment. Conclusion: The Danish version of ADHD-RS is valid and clinically feasible when measuring HKD symptom load in a CAMH-setting. The questionnaire provides useful data in patient management, quality improvement and service planning as well as in effectiveness studies of different interventions for patients with HKD and related disorders in routine clinical settings. [source] | ||||||||||