916 resultados para major clinical study


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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

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This study aimed to stablish the efficacy of a multivitamin and polyminerals supplemented with Panax ginseng extract (Natus Gerin(R)) on patients subjected to common physical or mental stress. Patients were randomly divided in two groups and underwent a thorough clinical examination. Group A received Natus Gerin(R) capsules and B placebo capsules. Two capsules were taken daily during meals during four weeks. Mood and physical activity were evaluated through a questionnaire assessing quality of life. From the 176 patients enrolled, 17 were excluded due to voluntary withdrawal, 81 completed the study in group A and 78 in group B. The treatment with Natus Gerin(R) increased the quality of life when compared to placebo. After 15 and 30 days, group A showed a significant increase in average scoring score from 1.78 to 3.78, and finally 5.32 points. The study has shown that the daily use of Natus Gerin(R) can be effective in improving quality of life in patients suffering from physical and mental stress.

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Painful bladder syndrome associated with interstitial cystitis (PBS/IC) is a clinical condition characterized pelvic pain, urinary urgency, and urinary frequency. In this study, 22 patients were assigned to make two visits over a three weeks period. The patients were randomly, double-blinded assigned in two groups. The first group received Cystex (R) capsules. The second group received placebo capsules. Two capsules were taken three times a day away from meals. The change from baseline in the O'Leary-Sant IC symptom and problem index was the primary outcome parameter. Changes in functional bladder capacity and intensity of pain and urgency have been chosen as secondary outcome parameters. Mood as well as physical and sexual activity were rated by 10 questions on a scale 0 to 6. The ratings were analyzed and the average for each patient in both groups Cystex (R) and placebo was determined as the quality of life index. For the primary outcome there was a statistically significant difference between the groups. Mean symptom score-sum decreased from 28.4 to 20.5 in the Cystex (R) group compared with 29.5 to 26.8 in the placebo group (p<0.05). For the secondary end points, pain and urgency intensity improved statistically significantly in the Cystex (R) group compared with the placebo group (p<0.05). The frequency and functional bladder capacity improved to greater degree in the Cystex (R) group. The differences were statistically significant for comparison of frequency (p<0.05) and not for functional bladder capacity (p>0.05). In our study, Cystex (R) enhanced quality of life over the placebo showing a statistically significant. This trial have shown that the efficacy and safety of therapy with Cystex (R) in the treatment of interstitial cystitis and is an alternative for patients suffering from this pathology. Therefore, it can be concluded that the composition of Cystex (R), increased the quality of life in treated patients.

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This study was carried out to describe the clinical characteristics of natural infection caused by Trypanosoma cruzi in dogs that reside in a rural area of Mato Grosso do Sul State, Brazil. Conventional and nonconventional diagnostic methods were used for screening T. cruzi infection in 75 dogs that lived in the area. Cardiovascular tests and biochemical examination of sera were also performed in four confirmed positive dogs. The following techniques were employed: indirect immunofluorescence test (IFAT), enzyme-linked immunosorbent assay with T. cruzi epimastigote antigens (EAE-ELISA) and enzyme-linked immunosorbent assay with T. cruzi excreted-secreted trypomastigote antigens (TESA-ELISA) with antibodies detected in 45.33% (n = 34), 24.0% (n = 18) and 12.0% (n = 9) of the dogs, respectively. The current prevalence of the infection was confirmed as 10.7% (n = 8) by immunoblotting test with T. cruzi excreted-secreted antigens (TESA-blot). The test that showed the best concordance index (Kappa; 0.93), sensitivity (100%) and specificity (98.5%) was TESA-ELISA, that when associated with IFAT had the same results as those obtained by TESA-blot (10.7%). Three out of the four chagasic animals showed enlarged cardiac silhouette on X-ray and an increase of the P-wave duration and QRS complex in electrocardiogram. Two dogs presented conduction disturbances, right bundle branch block in one dog and first-degree atrioventricular block and sinus arrest in another. The ecodopplercardiography presented left-ventricular-wall thickness increased during diastole, decrease of the shortening fraction and inversion in the speed peaks of the E and A waves, indicating the presence of systolic and diastolic disorders. The four animals showed enzymatic activities of creatine kinase (221-404 U/L), MB fraction of creatine kinase (189-304 U/L), elevated total proteins (7.6-10.2 g/dL) and total globulins (4.6-7.7g/dL) and reduction of albumin/globulin ratio, which suggested a myocardial injury and continuous antigenic stimulus.

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The sediment from urinary bladder washings from 63 consecutive autopsies was cytologically studied in order to achieve a better understanding of the changes in urothelial cells collected from hospital populations. The observed alterations were correlated with alterations in the urinary system and with therapy preceding death. The specimens obtained were of good quality. In 39.7% of the cases, the sediment contained giant superficial multinucleated cells. Three of nine cases previously subjected to radiation or chemotherapy showed atypical urothelial cells. In three cases with immunosuppression, there was cytologic evidence of subclinical infection by polyomavirus, and virus particles were identified by electron microscopy of the vesical mucosa. The study of the smear background offered additional information: the sediment contained hyaline or hematic or hyaline-cellular casts in 17.4% of the cases, in all of which there were renal tubulopathies when the kidney sections were studied. The method is useful for a good evaluation of the autopsy as well as for training in urinary cytopathology.

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Background - Paracoccidioidomycosis is the most frequent among the systemic mycoses in Brazil. Objective: To study the cases of paracoccidioidomycosis diagnosed from 1976 to 1996 at the Department of Dermatology of the School of Medicine of Botucatu. Methods - Descriptive study obtained from specific protocols comprising anamnesis, clinical- dermatological-laboratorial examination, treatment and follow-up of the patients. Results - Paracoccidioidomycosis was diagnosed in 1.04% of the dermatologic outpatients assisted from 1976 to 1996. In 315 cases, 89.8% were male, 61.9% were over forty and 53.7% were rural workers. The complaints were related more to oropharyngolaryngeal (53.6%) or cutaneous (23.8%) lesions or adenopathy (10.2%). Seventy patients had already been treated in other health services. The chronic multifocal clinical from was the most common: 80.6% of the cases, followed by the acute-subacute (juvenile type) 15.5%. The disease was pulmonary in 80.0%, oropharyngolaryngeal in 69.2% and cutaneous in 45.7%. Th treatment: Amphotericin B in 146 patients, Ketoconazole - 88, Itraconazole - 56, Sulfonamide derivatives - 146 and Terbinafine in 3. The lethality index resulting from the disease or its treatment was 2.0%. Conclusions - The high number of cases, showing the regional relevance of the disease and the high percentage of tegumentary complaints and the high number of relapsing are remarkable.

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Background: Tinea capitis is a common skin disease seen predominantly in children. The standard therapies for this disease are griseofulvin and ketoconazole. Nevertheless, these drugs have drawbacks in that they are only fungistatic and require treatment for at least 6 weeks. Previous studies with oral terbinafine for the treatment of Tinea capitis have shown that this agent is effective when given for 4 weeks, comparable to an 8-week regimen with griseofulvin. To date there is no data on the use of oral terbinafine in Brazilian children. Objectives: To assess the efficacy, safety and tolerability of oral terbinafine in short-term treatments (1-, 2- and 4-week treatment) of Tinea capitis in children. Patients and methods: One hundred and thirty-two children aged 1-14 years were enrolled in this study, but only 107 were considered for the final efficacy analysis. Diagnosis included clinical assessment and examination by Wood's light. Confirmation was obtained by direct microscopy and culture for fungus. Terbinafine dosage (125 or 250 mg/day) was adjusted according to patient weight. Efficacy was evaluated both by clinical and mycological assessment. Safety and tolerability variables included data on adverse reaction and clinical laboratory evaluations. Results: Mycological evaluation in the follow-up visit at week 12 showed negative direct microscopy and culture results in 48.6, 60.5 and 69.7% patients in groups 1-, 2- and 4-week, respectively (n.s.). At week 12, 84.8% patients in group 4-week achieved clinical cure with a significant difference compared to groups 1- and 2-week, 54.3 and 60.5%, respectively (P < 0.01). Adverse reactions were present in 4.8, 6.8 and 10.9% of patients in groups 1-, 2- and 4-week, respectively. Terbinafine was not associated with clinically relevant increases in liver function tests. Conclusions: Terbinafine is an effective, well tolerated and safe antifungal agent for the treatment of Tinea capitis m children. The shorter duration of treatment resulted in lower cure rates. However, it is important to note that depending on the severity of the disease, a 1-week-only treatment can also be effective in this indication.

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The purpose of this study was to compare the efficacy and tolerability of venlafaxine and amitriptyline in outpatients with major depression with or without melancholia. This was an 8-week, multicentre, randomized, double-blind, parallel-group comparison of venlafaxine and amitriptyline. Outpatients with DSM-IV major depression, a minimum score of 20 on the 21-item Hamilton Depression Rating Scale (HAM-D), and depressive symptoms for at least 1 month were eligible. Patients were randomly assigned to venlafaxine or amitriptyline, both drugs titrated to a maximum of 150 mg/day until study day 15. The primary efficacy variables were the final on-therapy scores on the HAM-D, Montgomery-Asberg Depression Rating Scale and Clinical Global Impression severity scales. Data were evaluated on an intent-to-treat basis using the LOCF method. One hundred and 16 patients were randomized, and 115 were evaluated for efficacy. Both drugs showed efficacy in the treatment of depression with or without melancholia. No significant differences were noted between treatments for any efficacy parameter. However, significantly (p < 0.05) more patients in the amitriptyline group had at least one adverse event. These results should support the efficacy and tolerability of venlafaxine in comparison with amitriptyline for treating major depression with or without melancholia.

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Purpose: The influence of early dental care on the prevalence of dental caries was determined in children ages 35 to 40 months divided into 2 groups of 160 children each, with 1 group participating in a dental care program from the first year of life to the time of the study, while the other group did not receive any dental care. Methods: The clinical conditions considered for the evaluation were: sound teeth, enamel caries without cavitation, enamel caries with cavitation, and dentinal caries. The proportion and chi-square tests were used for statistical analysis with the level of significance set at 5%. Results: A significant difference regarding the presence of dental caries, especially in the number of children presenting enamel caries with cavitation (P<.0001), was observed between the 2 groups. The number of children with enamel caries without cavitation and dentinal caries was similar for the 2 groups. Conclusions: Considering the aspect of dental caries prevention, the authors concluded that children in the age range of 3 to 4 years who received early dental care showed better oral conditions.

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Objective: The aim of this study was to evaluate the effectiveness of the clinical use of the gallium-aluminum-arsenium (GaAlAs) laser at the maximum and minimum energies recommended by the manufacturer for the treatment of dentine hypersensitivity. Background Data: Dentine hypersensitivity (DH) is a response to a stimulus that would not usually cause pain in a healthy tooth. It is characterized by sharp pain of short duration from the denuded dentin. Its etiology is unknown. The dentin only begins to show sensitivity when exposed to the buccal environment. This exposure can result after removal of the enamel and/or dental cement, or after root denudation. Different treatments are proposed for this disorder. Materials and Methods: In this study, 25 patients, with a total number of 106 cases of DH, were treated with GaAlAs low-level laser therapy (LLLT). 65% of the teeth were premolars; 14% were incisors and molars; 6.6% were canines. The teeth were irradiated with 3 and 5 J/cm 2 for up to six sessions, with an interval of 72 h between each application, and they were evaluated initially, after each application, and at 15 and 60 days follow-up post-treatment. Results: The treatment was effective in 86.53% and 88.88% of the irradiated teeth, respectively, with the minimum and maximum energy recommended by the manufacturer. There was a statistically significant difference between DH and after a follow-up of 60 days for both groups. The difference among the energy maximum and minimum was not significant. Conclusion: The GaAlAs low-level laser was effective in reducing initial DH. A significant difference was found between initial values of hypersensitivity and after 60 days follow-up post-treatment. No significant difference was found between minimum (3 J/cm 2) and maximum (5 J/cm 2) applied energy.