Search PubMed⌕ Search

Biomedical subjects

A Solari

Publications and source records attributed to A Solari.

At least 19 recordsLinked to original sources

Randomized, double-blind, placebo-controlled trial of phenylbutyrate in spinal muscular atrophy.

OBJECTIVE: To assess the efficacy of phenylbutyrate (PB) in patients with spinal muscular atrophy in a randomized, double-blind, placebo-controlled trial involving 10 Italian centers. METHODS: One hundred seven children were assigned to receive PB (500 mg/kg/day) or matching placebo on an intermittent regimen (7 days on/7 days off) for 13 weeks. The Hammersmith functional motor scale (primary outcome measure), myometry, and forced vital capacity were assessed at baseline and at weeks 5 and 13. RESULTS: Between January and September 2004, 107 patients aged 30 to 154 months were enrolled. PB was well tolerated, with only one child withdrawing because of adverse events. Mean improvement in functional score was 0.60 in the PB arm and 0.73 in placebo arm (p = 0.70). Changes in the secondary endpoints were also similar in the two study arms. CONCLUSIONS: Phenylbutyrate was not effective at the regimen, schedule, and duration used in this study.

Child↗

Improvement in quality of life and activity limitations in migraine patients after prophylaxis. A prospective longitudinal multicentre study.

Improved health-related quality of life (HRQOL) and reduced activity limitations are prime objectives of migraine therapy, but no data on the effect of preventive treatments on these outcomes are available. We monitored changes in HRQOL using the Short Form 36 (SF-36) and headache-related activity limitations using the Migraine Disability Assessment Score (MIDAS) in 141 consecutive migraine without aura patients on prophylaxis. A total of 102 patients completed the 3-month study. Mean (SD) number of headache days/month dropped from 8.0 (3.7) to 5.0 (2.3) (P < 0.001). Mean monthly consumption of acute drugs reduced from 7.4 (3.5) to 4.4 (3.1) (P < 0.001). MIDAS total score reduced (improved) significantly. All SF-36 scale scores increased (improved), most significantly. This first study to assess prospectively the impact of prophylaxis on HRQOL and daily activities in a large series indicates that migraine prophylaxis has the potential to reduce the global burden of migraine on individuals and society.

Activities of Daily Living↗

Local drug delivery in recurrent malignant gliomas.

In recurrent malignant gliomas, we scheduled a protocol by adding to systemic temozolomide a local treatment delivered through a reservoire positioned in the surgically created cavity, consisting of either mitoxantrone, liposome-loaded doxorubicine or nimustine (ACNU). The progression-free survival (PFS) and survival time (ST) of the whole group of 112 patients were 8.3 and 11 months, respectively, in GBM patients, and 14 and 18 months in AA patients. To limit the selection bias in recruitment we matched locally treated patients with the whole group of patients treated for 3 years and having undergone the same protocol with the exception of local drug delivery. Variables such as age, histology and local chemotherapy delivery were proved to be statistically significant independent factors on adjunctive PFS and ST. Another group of 12 recurrent malignant gliomas with further progression was locally managed according to convection-enhanced delivery (CED) of mitoxantrone; the preliminary results show good tolerability of the schedule.

Adolescent↗

Intense immunosuppression followed by autologous stem cell transplantation in severe multiple sclerosis.

Aggressive forms of multiple sclerosis (MS) represent a limited group of demyelinating diseases that rapidly progress to severe disability. Currently available therapies are poorly effective against these clinical entities. Recently, it has been demonstrated that intense immunosuppression followed by autologous haematopoietic stem cell transplantation (AHSCT) can affect the clinical course of individuals with severe MS and completely abrogate the inflammatory activity detected by MRI. We report the result of the Italian phase 2 GITMO study, a multicentre study in which 21 MS patients, who were rapidly deteriorating and not responding to the usual therapeutic strategies, were treated with this procedure. The clinical effect of the treatment is long lasting, with a striking abrogation of inflammation detected by MRI findings. These results support a role for intense immunosuppression followed by ASCT as treatment in rapidly evolving MS cases unresponsive to conventional therapies.

Adult↗

Itraconazole or allopurinol in the treatment of chronic American trypanosomiasis: the results of clinical and parasitological examinations 11 years post-treatment.

Eleven years after they had been given itraconazole or allopurinol for the treatment of chronic American trypanosomiasis, 109 adult patients were checked for electrocardiographic abnormalities and evidence of Trypanosoma cruzi infection. The parasitological investigations included xenodiagnosis, in which the faeces of Triatoma infestans that had fed on the patients were checked under the microscope for flagellates. In addition, a PCR-based assay and a hybridization assay were used to test blood samples from the patients, and faeces from the Tri. infestans that had fed on the patients, for Try. cruzi DNA. For the data analysis, the patients were divided into four groups known as normal/normal, abnormal/normal, normal/abnormal and abnormal/abnormal, according to whether the patients had been found to have normal or abnormal electrocardiograms (ECG) shortly before the first treatment and to have normal or abnormal ECG when checked at the 11-year follow-up. The 51 normal/normal and 24 normal/abnormal patients were assumed to have been in the 'indeterminate' phase of the disease when they were treated, whereas the 16 abnormal/normal and 18 abnormal/abnormal patients all had evidence of chagasic cardiopathy at that time. When checked 11 years post-treatment, 40 (78.4%), 17 (70.8%), 14 (87.5%) and 17 (94.4%) of these patients, respectively, were each found positive for Try. cruzi in at least one of the parasitological tests. The hybridization assay, whether applied to human blood or bug faeces, appeared a significantly more sensitive test than the PCR-based assays or microscopically assessed xenodiagnosis (P<0.05). Only the 21 patients who appeared to be negative for Try. cruzi could be considered parasitologically cured (although all still appeared to have anti-Try. cruzi antibodies in their blood). Only 13 of these parasitologically cured patients (seven of those treated with itraconazole and six of those given allopurinol) had normal ECG at the 11-year follow-up. In Chile at least, itraconazole, which caused fewer adverse effects than the allopurinol while being no less effective at preventing cardiopathy, appears to be the drug of choice to treat chronic American trypanosomiasis in adults.

Adult↗

Italian version of the Chicago multiscale depression inventory: translation, adaptation and testing in people with multiple sclerosis.

Depression is the commonest psychiatric disturbance in people with multiple sclerosis (MS), with prevalence higher than in the general population and other chronic diseases. However, accurate assessment of depressive symptoms can be biased by somatic symptoms which are part of both MS and depression. We translated and adapted into Italian the Chicago multiscale depression inventory (CMDI) and assessed its acceptability, internal consistency and test-retest reliability in 213 MS outpatients and 213 individually matched healthy controls. The questionnaire was also tested in 32 people with major depression. Acceptability, internal consistency, and test-retest reliability were good overall. We found greater odds for depressive symptoms in people with MS than healthy controls, with highest odds ratio for somatic symptoms (vegetative subscale). The Italian CMDI is characterized by good acceptability, internal consistency, and test-retest reliability. These findings support the use of the CMDI in Italian subjects with MS to screen for and follow depressive symptoms.

Adolescent↗

General practitioners facing dementia: are they fully prepared?

We assessed knowledge about Alzheimer's disease (AD) in a sample of Italian general practitioners (GPs). We first carried out a propedeutic study to verify the ability of an Italian version of the University of Alabama at Birmingham's AD Knowledge Test for Health Professionals to distinguish between 20 AD specialists and 20 non-specialists and to gain reference values. We then administered the test, together with a short questionnaire, to 139 GPs attending an educational programme in November 2000. The cut-off score for discriminating specialists from non-specialists was >/=9. Among the 95 GPs who performed the AD Knowledge Test (68.3% response rate), 21% had a total score >/=9. Our findings suggest that particular focus should be given to dementia in continuing medical education (CME) programmes for GPs.

Adult↗

Disability and quality of life in different primary headaches: results from Italian studies.

Headaches may have a wide range of impact on patients' lives. We report the results of Italian studies in which disability and health-related quality of life (HRQOL) in patients with different primary headaches were evaluated. The Short Form 36 (SF-36) was used to assess HRQOL; the Migraine Disability Assessment Score questionnaire (MIDAS) was used to assess disability in patients with migraine without aura or with chronic migraine. Mean MIDAS total scores were evaluated in migraine without aura and chronic migraine patients. The scores at the eight SF-36 scales were calculated in patients with the three studied headaches, and were compared with Italian normative data (Student's t-test with Bonferroni correction). Primary headaches had a considerable negative impact on patients' lives, with poor quality of life and decreased ability to function in daily duties. The mean MIDAS total score was 23.4 in 264 patients with migraine without aura, and 79.2 in 150 patients with chronic migraine. Mean SF-36 scores in migraine without aura (68 subjects), chronic migraine (84) and cluster headache (56) were lower than those from the Italian general population, with significant differences for 3 scales in migraine without aura, for 6 in chronic migraine, and for all scales in cluster headache. Our results confirmed a marked personal and social burden in patients with migraine without aura, and also in the less well-studied forms of primary headaches, cluster headache and chronic migraine.

Adult↗

Measuring responses to therapy in headache patients: new and traditional end-points.

Changes in numerical indices of the intensity, duration and frequency of attacks are traditionally used to assess the effectiveness of treatments for migraine and other primary headaches. However, recent clinical and therapeutic guidelines and guidelines for conducting clinical trials specify that the essential aim of symptomatic and prophylactic migraine treatments should be to reduce the global impact of the headaches on the patient's life. Some standardised instruments for assessing disability and health-related quality of life seem sensitive to treatment-induced changes in primary headache patients. However, further studies to determine the suitability of these instruments as outcome measures in clinical practice are necessary.

Disability Evaluation↗

Disability in young patients suffering from primary headaches.

During the last decade researchers have begun to employ standardised methodologies to investigate the global impact of primary headaches. Disease-specific instruments have been developed to measure headache-related disability. The MIDAS Questionnaire, which is the most extensively studied of these instruments, was designed to assess the overall impact of headaches over the 3 months before compilation. The MIDAS Questionnaire is an optimal tool to assess headache-related disability in adults in relation to patients' daily activities. Primary headaches are a recurrent problem for children and adolescents. Forty percent of children have experienced headaches by the age of 7 years increasing to 75% by the age of 15. In a recent report we determined the suitability of the MIDAS Questionnaire in its original form for assessing disability in children and adolescents suffering from different kinds of headache. This was the first step of a line of research aimed to develop a new MIDAS Questionnaire adapted for young patients. In this second study the aims were: (1) to produce a new version of the MIDAS Questionnaire specific for young patients suffering from different forms of headache; (2) to assess the reliability of this new instrument; (3) to assess its sensitivity to treatment intervention.

Adolescent↗

Trypanosoma cruzi isolates from Chile are heterogeneous and composed of mixed populations when characterized by schizodeme and Southern analyses.

In total, 61 Chilean isolates of Trypanosoma cruzi, were analysed using schizodeme and Southern analysis, using as probes the highly variable regions of minicircles from cloned parasites. Isolates were collected and amplified from domestic and wild triatomines, and from infected subjects in all the endemic areas of Chile. Three major parasite genotypes could be detected in the domestic transmission cycle, whilst 1 major T. cruzi genotype is circulating in the wild transmission cycle. Schizodeme analysis suggested that T. cruzi isolates are mixed populations, whereas the Southern analyses detected only 3 mixed isolates using 4 selected minicircle segments as probes.

Animals↗

Idebenone treatment in Friedreich patients: one-year-long randomized placebo-controlled trial.

The authors carried out a 1-year, randomized, placebo-controlled trial of idebenone in 29 patients with Friedreich ataxia. They found significant reductions of interventricular septal thickness and left ventricular mass in the idebenone group vs the placebo group, with no improvement in other heart ultrasound measures or neurologic condition. The absolute cardiac changes were modest, but the findings suggest that larger trials should assess whether idebenone reduces ventricular hypertrophy in patients with Friedreich ataxia.

Adolescent↗

Amantadine for fatigue in multiple sclerosis.

BACKGROUND: Fatigue is one of the most common and disabling symptoms of people with Multiple Sclerosis (MS). The effective management of fatigue has an important impact on the patient's functioning, abilities, and quality of life. Although a number of strategies have been devised for reducing fatigue, treatment recommendations are based on a limited amount of scientific evidence. Many textbooks report amantadine as a first-choice drug for MS-related fatigue because of published randomised controlled trials (RCTs) showing some benefit. We performed a systematic review in order to gather existing evidence, and contribute to the topic. OBJECTIVES: To determine the effectiveness and safety of amantadine in reducing fatigue in people with MS. SEARCH STRATEGY: RCTs of amantadine were identified using MEDLINE, EMBASE, bibliographies of relevant articles, personal communications, manual searches of relevant journals, and information from drug companies. SELECTION CRITERIA: Randomised, placebo or other drugs-controlled, double-blind trials of amantadine in MS people with fatigue. DATA COLLECTION AND ANALYSIS: Three reviewers selected studies for inclusion in the review and they extracted the data reported in the original articles. Missing and unclear data were requested by correspondence with the trial's principal investigator. A meta-analysis was not performed due to the inadequacy of available data, heterogeneity of outcome measures. MAIN RESULTS: Out of twelve pertinent publications, four trials met the criteria for inclusion in this review: one study was a parallel arms study, and 3 were crossover trials. The number of randomised participants ranged between 10 and 115, and a total of 236 MS patients had been studied. Overall the quality of the studies considered was poor and all trials were open to bias. All studies reported small and inconstant improvements in fatigue, whereas the clinical relevance of these findings and the impact on patient's functioning and health related quality of life remains undetermined. The number of participants reporting side effects during amantadine therapy ranged from 10% to 57%, without significant differences between treatment and placebo. The side effects reported were generally mild, and discontinuation of the drug due to side effects occurred in less than 10% of the patients. REVIEWER'S CONCLUSIONS: Amantadine treatment is overall well tolerated, however its efficacy in reducing fatigue in people with MS is poorly documented and there is insufficient evidence to make recommendations to guide prescribing. It is advisable to (a) improve knowledge on the underlying mechanisms of MS-related fatigue; (b) achieve an agreement on accurate, reliable and responsive outcome measures of fatigue; (c) perform good quality RCTs.

Amantadine↗

Quality of life and disability in primary chronic daily headaches.

We assessed functional disability and health-related quality of life (HRQOL) in Italian patients suffering from chronic migraine and medication overuse (150 subjects) or chronic cluster headache (22 subjects). We used the validated Italian versions of the Migraine Disability Assessment Score (MIDAS) and of the Short Form 36 (SF-36). Patients with both conditions were characterised by significantly lower scores on most SF-36 scales than Italian normative data (Student's t test with Bonferroni correction). MIDAS scores revealed that patients had severe limitations in their ability to function, with high proportions forced to stop work and non-work activities, or experiencing significantly reduced productivity in all activity domains. These findings show that primary chronic headaches have a marked negative influence on patients' lives, compromising their sense of well being and their ability to function in different roles. We also found that MIDAS and SF-36 were sensitive to clinical changes in a group of 84 patients with chronic migraine and medication overuse who completed the both questionnaires before and after treatment.

Activities of Daily Living↗

Chromosomal size variation in Trypanosoma cruzi is mainly progressive and is evolutionarily informative.

The evolutionary significance of chromosome size polymorphism was explored in a representative panel of 26 Trypanosoma cruzi stocks. We tested a progressive model (aCSDI) assuming that the larger the size difference between homologous chromosomes, the more divergent the parasites are. This was contrasted with a non-progressive model (Jaccard's distance), in which any chromosome size difference has the same weight. ACSDI-based dendrograms were very similar to those built-up from multilocus enzyme electrophoresis (MLEE) and random amplified polymorphic DNA (RAPD) data: structuring in 2 major lineages (T. cruzi I and T. cruz II) and 5 small subdivisions within T. cruzi II was identical, and branching was very similar. Furthermore, a significant correlation (P < 0.001) was observed between aCSDI and phenetic distances calculated from MLEE and RAPD data. In contrast, analysis of chromosome size polymorphism with Jaccard's distance generated dendrograms with relatively long branches, causing most branching points to cluster close together, which generates statistically uncertain branching points. Our results thus support a model of progressive chromosome size-variation and show that despite an extensive polymorphism, chromosomal sizes constitute valuable characters for evolutionary analyses. Furthermore, our data are consistent with the clonal evolution model previously proposed for T. cruzi.

Animals↗

Health-related quality of life in patients with cluster headache during active periods.

Cluster headache is characterized by excruciatingly painful headaches which occur one or several times during the day. Little is known about the functional consequences of this severe headache form. We assessed health-related quality of life in 56 consecutive patients, 34 of whom were episodic cluster headache patients during an active period, and 22 had chronic cluster headache. All patients completed the Short Form-36 (SF-36). We found lower scores in the studied patients than in those reported in the general population for all SF-36 domains. For most scales the difference was significant (P < 0.0001, Student's t-test, Bonferroni correction). Our findings suggest that cluster headache has marked functional consequences even when appropriate treatments are used.

Activities of Daily Living↗

Comparison of two brief neuropsychological batteries in people with multiple sclerosis.

BACKGROUND: We compared two brief neuropsychological batteries devised to assess people with multiple sclerosis (MS) and used them to assess the relationship between cognitive impairment and dinical characteristics. METHODS: We administered either the Brief Repeatable Battery of Neuropsychological Tests (BRBNT) or the Screening Examination for Cognitive Impairment (SEFCI) to 213 consecutive MS outpatients and 213 individually matched controls. RESULTS: Administration times were longer for BRBNT than SEFCI, for MS and controls (p=0.001). People with MS had lower scores in all individual tests than controls (p<0.001, BRBNT and SEFCI). By the criterion of poor performance on one or more tests, the sensitivity of BRBNT was 41.9% and that of SEFCI 31.5%. The corresponding figures by poor performance on two or more tests were 16.2% for BRBNT and 18.5% for SEFCI. The Buschke Selective Reminding and Paced Auditory Serial Addition were the tests best discriminating between people with MS and controls for BRBNT, and the Symbol Digit Modalities test for SEFCI. The only clinical variable independently associated with impaired performance on these batteries was EDSS. CONCLUSIONS: Both cognitive batteries were well accepted and easy to administer. Administration time for SEFCI was significantly shorter than for BRBNT; however, alternative forms for serial evaluation are available only for BRBNT. The BRBNT was slightly more sensitive in detecting impairment by the criterion of poor perfomance on one or more tests. EDSS score was the only clinical variable independently associated with cognitive impairment

Adolescent↗

Trypanosoma cruzi: presence of the two major phylogenetic lineages and of several lesser discrete typing units (DTUs) in Chile and Paraguay.

Multilocus enzyme electrophoresis (MLEE) of 99 Chilean and 11 Paraguayan stocks of Trypanosoma cruzi, the agent of Chagas disease, was performed for 22 variable genetic loci. As previously shown for this parasite in other geographic areas, a pattern of long-term clonal evolution of T. cruzi genotypes was inferred, both by strong departures of Hardy-Weinberg expectations and high linkage disequilibrium. The presence of the two major phylogenetic lineages that subdivide the species T. cruzi [Tibayrenc, M., 1995. Population genetics of parasitic protozoa and other microorganisms. In: Baker, J.R., Muller, R., Rollinson, D. (Eds.), Advances in Parasitology, vol. 36, Academic Press, New York, pp. 47-115; Souto, R.P., Fernandes, O., Macedo, A.M., Campbell, D.A., Zingales, B., 1996. DNA markers define two major phylogenetic lineages of Trypanosoma cruzi. Mol. Biochem. Parasitol. 83, 141-152], and of several lesser genetic subdivisions ('discrete typing units' or DTUs; Tibayrenc, M., 1998a. Genetic epidemiology of parasitic protozoa and other infectious agents: the need for an integrated approach. Int. J. Parasitol. 28 (1), 85-104; Tibayrenc, M., 1998b. Beyond strain typing and molecular epidemiology: integrated genetic epidemiology of infectious diseases. Parasitol. Today 14, 323-329; Tibayrenc, M., 1998c. Integrated genetic epidemiology of infectious diseases: the Chagas model. Mem. Inst. Oswaldo Cruz 93 (5), 577-580), was recorded in this region. Comparison between clonal populations in sylvatic and domestic transmission cycles of the disease in Chile strongly suggests that these two cycles are at least partially separated from one another.

Animals↗