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At least 1,207 records · Page 67Linked to original sources
PubMed2002

Efficacy and safety of a phytoestrogen preparation derived from Glycine max (L.) Merr in climacteric symptomatology: a multicentric, open, prospective and non-randomized trial.

A multicentric, open, prospective, observational and no-randomized clinical trial was carried out in Spain with 190 postmenopausal women receiving a soy preparation rich in isoflavones (PHYTO SOYA, capsules containing 17.5 mg isoflavones). The main object of the present study was to investigate its efficacy in alleviating the symptomatology derived from the lack of estrogen, mainly hot flushes, but also other symptoms such as sleep disorder, anxiety, depression, vaginal dryness, loss of libido and bone pain. Each patient received 35 mg isoflavones per day in two doses. During the four months' treatment, a statistically significant decrease in the number of hot flushes with PHYTO SOYA was experienced by 80.82% women; only 5,48% patients did not improve with the treatment. The average reduction was 47.8%, which is equivalent to 4 hot flushes. All the other studied parameters also showed a statistically significant decrease. No severe side-effects were reported and tolerance was excellent. Treatment with PHYTO SOYA resulted in a significant improvement of the symptomatology that accompanies the lack of estrogen during menopause.

Anxiety↗
PubMed2001

Patch testing of nickel sulfate and potassium dichromate with a standardized ready-to-use test system gives highly reproducible results: a double-blind multicentre study.

There is still some doubt about the reproducibility of patch tests. A sound assessment needs optimized and unbiased studies. This study analysed the results of a double-blind multicentre study with nickel sulfate and potassium dichromate patch tests attached synchronously to both sides of the back of patients with a history of nickel allergy, conducted with a highly standardized randomized test system (TRUE-test). Out of 589 patients tested, a total of 388 had responded with allergic reactions to nickel sulfate and 130 to potassium dichromate. The reproducibility of positive nickel (dichromate) patch tests was 99.2% (90.8%). The reaction index was also calculated, which relates the number of allergic reactions obtained with a test preparation to the number of questionable and irritant reactions; the reaction index can range from -1 (questionable and irritant reactions only occur) to 1 (allergic reactions only occur). For nickel sulfate the reaction index was 0.91, but it was only 0.23 for potassium dichromate, as a result of considerably more questionable reactions. In conclusion, a highly synchronous reproducibility of results can be achieved by using a well-standardized patch-test system, especially with nickel sulfate. However, distinct allergens and test systems need to be evaluated separately.

Adult↗
PubMed2002

Effect of combined interferon-alpha induction therapy and ribavirin on chronic hepatitis C virus infection: a randomized multicentre study.

BACKGROUND: The efficacy of interferon-alpha (IFN) induction in combination with ribavirin for chronic hepatitis C virus (HCV) infection is not known. METHODS: A total of 256 treatment-naive HCV RNA-positive patients with biopsy-confirmed chronic hepatitis were enrolled in a randomized multicentre study. The patients received either standard combination therapy with 3 MIU interferon-alpha2b thrice weekly for 26 weeks or 6 MIU interferon-alpha2b daily for 4 weeks and 3 MIU 3/7 days for 22 weeks. All patients received ribavirin 1000 mg or 1200 mg (weight dependent) daily during the 26-week treatment period. Patients were monitored for HCV RNA during and following treatment. RESULTS: The sustained virological response rates (26 weeks after end of treatment) were 54% and 47% for patients receiving IFN induction/ribavirin and standard IFN/ribavirin, respectively (P = 0.35). Among patients infected with genotype 1a/1b, the sustained response rates were 32% and 35%. In patients infected with genotype 2b/3a IFN induction/ribavirin led to a sustained response rate of 80% as compared to 65% in the standard combination therapy group (P = 0.073). Steatosis was more frequently seen in liver biopsies from patients infected with genotype 3a as compared to genotypes la/lb. Among genotype 1a/1b infected patients. steatosis was a highly significant predictor of failure to achieve sustained virological response. Logistic regression analysis (multivariate analysis) showed that independent predictors of sustained virological response were low age, female gender, genotype 2b/3a and HCV RNA negativity at 2 weeks. CONCLUSIONS: IFN induction in combination with ribavirin does not increase the sustained virological response rate among patients infected with HCV. Absence of steatosis is an independent predictor of sustained virological response in patients infected with genotypes 1a/1b.

Adult↗
PubMed2000

Short therapy with amoxicillin-clavulanate and corticosteroids in acute sinusitis: results of a multicentre study in adults.

Evolution of bacterial resistance shortens antibiotic treatment in ENT infections. The efficacy and tolerance of amoxicillin-clavulanate (ACA), with and without associated short steroid therapy, was evaluated in acute sinusitis of adults at a dosage of 1.5 g/d for 5 d vs. 10 d. This multicentre, randomized, double-blind, placebo-controlled study included 433 patients, 417 of whom were suitable for intent-to-treat (ITT) analysis. The therapeutic success rate in the ITT population, assessed according to strict clinical and radiological criteria, was respectively, 80% and 85% in the 5-d and 10-d treatment groups. Due to the statistical risks that were evidenced, the 2 durations of treatment could not be considered equivalent. The analysis of medical history shows that some risk factors (recurrence of sinusitis, previous surgical sinus drainage) seem to promote therapeutic failure and that 5-d treatment is inappropriate in these patients. The persistence of therapeutic success on day 30 was not influenced by the initial duration of treatment. The efficacy and good tolerance of ACA in acute sinusitis in adults were confirmed. Further studies will be needed to define the indications of short treatments better, which seem to be indicated in the absence of specific risk factors.

Acute Disease↗
PubMed2002

A multicentre review of the tension-free vaginal tape procedure in clinical practice.

A multicentre study was conducted to determine the success of the TVT in a clinical practice and to try to identify factors which may be associated with operative failure or postoperative complications. Three hundred and twenty women were included; the overall subjective success rate was 92.2%; 245 patients had reliable documentation regarding postoperative voiding, 25 had voiding problems (10.2%). Operative success did not appear to be diminished by previous surgery. Increased patient weight had a positive effect on outcome. Irritative symptoms preoperatively had an odds ratio of 1.8 for postoperative voiding difficulties. This study shows that the TVT appears to be an effective operation for genuine stress incontinence with low intra and postoperative complication rates. These results also show that it is highly successful in patients who may not be ideal candidates for other continence procedures either because of previous pelvic surgery or body weight.

Adult↗
PubMed2003

Residues of DDT and HCH pesticides in rice samples from different geographical regions of India: a multicentre study.

As part of a multicentre study conducted by the Indian Council of Medical Research, 2000 samples of rice were collected from rural and urban areas of 13 states representing different geographical regions of India. The samples were analyzed for residues of DDT [2,2-bis(p-chlorophenyl)-1,1,1-trichloroethane] and different isomers of HCH [1,2,3,4,5,6-hexachlorocyclohexane, a mixture of isomers] by gas-chromatography. Residues of DDT and HCH, respectively, were detected in about 58 and 73% of the samples analysed. Medians of both DDT and HCH in rice samples were around 0.01 mg kg (-1). Concentrations of alpha-, beta-, gamma- and delta-HCH exceeded a maximum residue limit of 0.05 mg kg (-1) for each isomer in rice fixed by the Ministry of Health and Family Welfare of the Indian Government in 4.3, 2.6, 1.7 and 1.2% of the samples, respectively. There is no statutory limit fixed in India for DDT residues in cereals. Its maximum residue limit of 0.1 mg kg (-1) in cereals recommended by Codex was exceeded by about 2% of the samples examined. Estimated intake of DDT and isomers of HCH through consumption of rice contaminated at their median and 90th percentiles constituted a small proportion of their acceptable daily intakes.

Chromatography, Gas↗
PubMed2006

Residues of DDT and HCH in wheat samples collected from different states of India and their dietary exposure: A multicentre study.

Under a multicentre study conducted by the Indian Council of Medical Research, 1712 samples of wheat grain/flour were collected from urban and rural areas in 11 states representing different geographical regions of India. These samples were analysed for residues of DDT (2,2-bis (p-chlorophenyl)-1,1,1-trichloro ethane) and different isomers of HCH (1,2,3,4,5,6-hexachloro cyclohexane, a mixture of isomers) by gas-liquid chromatography. Residues of DDT were detected in 59.4% of 1080 samples of wheat grain and in 78.2% of 632 samples of wheat flour. Different isomers of HCH were present in about 45-80% of the samples of wheat grain/flour. Medians of DDT and total HCH, respectively, for pooled samples of wheat grain were 0.013 and 0.035 mg kg(-1), while those for wheat flour were 0.01 and 0.02 mg kg(-1). Estimated daily intakes of DDT and different isomers of HCH through the consumption of wheat contaminated at their median and 90th percentiles constituted a small proportion of their acceptable daily intakes. Amongst the pesticide residues analysed, statutory maximum residue limits have been fixed only for gamma-HCH in wheat in India, as 0.1 mg kg(-1) in wheat grain and zero in wheat flour. Residue levels of gamma-HCH exceeded these maximum residue limits in five of 1080 samples of wheat grain and in 340 of 632 samples of wheat flour. The failure to meet the requirement of the gamma-HCH maximum residue limit in large number of wheat flour samples was attributed to the fixation of practically unachievable zero limit. Comparing the previous studies and the present one, the levels of residues of DDT and HCH in wheat were significantly decreased.

Adult↗
PubMed1996

Aflatoxin B1 contamination in groundnut samples collected from different geographical regions of India: a multicentre study.

Under a multicentre study conducted by the Indian Council of Medical Research, 2062 samples of groundnut were collected from rural and urban areas of 11 states representing different geographical regions of the country. These samples were analysed for aflatoxin B1 using the AOAC method. Analytical quality assurance between various participating laboratories was ensured through analysis of check-samples. Twenty-one per cent of groundnut samples collected from 11 states exceeded the permissible Indian regulatory limit of 30 micrograms/kg. No statistically significant difference in percentage of samples contaminated (> 30 micrograms/kg) were observed between pooled rural (22.9%) and urban (19.9%) data. Amongst the 11 states, the minimum and maximum per cent contamination respectively (> 30 micrograms/kg) was observed to be 15.2 in the state of Andhra Pradesh and 28.3 in the state of Haryana. The maximum level of contamination of 833 micrograms/kg was observed in the state of Gujarat. The median level of < 5 micrograms/kg was observed in the states of Gujarat, Haryana, Punjab, Andhra Pradesh and Karnataka. In all other states studied, the median level was found to vary between 10 and 20 micrograms/kg. The 90th percentile values were high in Andhra Pradesh (125 micrograms/kg), Gujarat (111 micrograms/kg) and Haryana (110 micrograms/kg). In the remaining states the 90th percentile value ranged from 60 to 93 micrograms/kg. Analysis of pooled data showed the percentages of samples exceeding the level of contamination of 5 micrograms/kg and 15 micrograms/kg, respectively were 44.9% and 37.4% which therefore, showed a marked increase when compared with the per cent of samples exceeding 30 micrograms/kg in the overall data.

Aflatoxin B1↗
PubMedDate not supplied

Aflatoxin B1 contamination in maize samples collected from different geographical regions of India--a multicentre study.

Under a multicentre study conducted by the Indian Council of Medical Research, 2,074 samples of maize were collected from rural and urban areas of 11 states representing different geographical regions of the country. These samples were analysed for aflatoxin B1 using the AOAC method. Analytical quality assurance between various participating laboratories was ensured through analysis of check-samples. About 26% of maize samples collected from 11 states exceeded the permissible Indian regulatory limit of 30 micrograms kg-1. No statistically significant difference in percentage of samples contaminated (> 30 micrograms kg-1) was observed between pooled rural (27.8%) and urban (23.7%) data. The maximum level of contamination of 666 micrograms kg-1 was observed in the state of Haryana. The median level of < 5 micrograms kg-1 was observed in the states of Gujarat, Haryana, West Bengal, Andhra Pradesh and Karnataka. In all other states studied, the median level was found to vary between 10 and 35 micrograms kg-1.

Aflatoxin B1↗
PubMed1999

DDT and HCH residues in dairy milk samples collected from different geographical regions of India: a multicentre study.

Under a multicentre study conducted by the Indian Council of Medical Research, 2205 samples of dairy milk were collected from rural and urban areas of 12 states representing different geographical regions of India. These samples were analysed for residues of DDT and different isomers of HCH by gas-liquid chromatography. Analytical quality assurance between various participating laboratories was ensured through analysis of check samples. The residues of DDT and HCH were detected in more than 80% of samples analysed. Concentrations of DDT residues, alpha-HCH, beta-HCH, gamma-HCH and delta-HCH exceeded their maximum residue limits prescribed by the Ministry of Health and Family Welfare of the Indian Government in 37, 21, 42, 28 and 4% of the samples, respectively. Median values of DDT and HCH found in dairy milk in India were more than the corresponding values reported from most other countries. The results showed significant variations in the incidence as well as level of these contaminants in dairy milk from different regions of the country.

Animals↗
PubMed2001

Prevalence of risk factors for aneurysmal subarachnoid haemorrhage: results of a Japanese multicentre case control study for stroke.

The pathogenesis of subarachnoid haemorrhage (SAH) is still unclear. To evaluate the risk factors for aneurysmal SAH, we conducted a multicentre case control study. All aneurysms were detected by cerebral angiography and the patients with SAH other than ruptured aneurysms were excluded. Information on past medical histories and other possible risk factors for SAH were assessed by a structured questionnaire. Data on the total 127 pairs (59 male and 68 female) were analysed. In a univariate analysis, family history of SAH [odds ratio (OR) 9.45], systemic hypertension (OR 2.65), cigarette smoking (OR 2.54) and regular alcohol consumption (OR 1.92) were significant risk factors for aneurysmal SAH. Heavy alcohol consumption (>350 g ethanol/week) was significant (OR 3.22), whereas light consumption (=<350 g/week) did not to increase the risks (OR 0.95). Both light (<20 cigarettes/day, OR 2.44) and heavy smoking (>=20 cigarettes/day, OR 2.72) were associated with an increased risk of SAH. In a multivariate analysis, after adjustment for other risk factors, family history of SAH, cigarette smoking and hypertension remained significant.

Adult↗
PubMed1999

Central assessment of bilateral phlebograms in a major multicentre thromboprophylactic trial. Reasons for inadequate results.

PURPOSE: To determine the cause of inadequate bilateral phlebograms at central assessment. A major antithrombotic trial was evaluated to identify and apply corrective measures for reducing inadequate results in future multicentre trials. MATERIAL AND METHODS: The inadequate results in 253 out of 1,827 patients having undergone bilateral phlebography following total hip replacement were reviewed by two central assessors using strict criteria for evaluability. The reasons for inadequate findings were assessed and ranked. RESULTS AND CONCLUSION: Insufficient contrast filling, especially of the anterior tibial, common femoral and iliac veins, was the most common reason for disqualifying examinations. Unilateral examinations and obscuring metallic devices were the second and third most common reasons, respectively. Efforts should be made to standardize the phlebography technique, to use a large volume of contrast without tourniquets, and to obtain an appropriate number of views to visualize the deep veins.

Arthroplasty, Replacement, Hip↗
PubMed2004

Fifty years of multicentric Castleman's disease.

Benjamin Castleman first described multicentric Castleman's disease (MCD) in a series of cases in 1954. Interest in MCD has grown in recent years following an association with human immunodeficiency virus (HIV) infection. Castleman's disease is separated into localized disease and MCD. The latter is characterized by polylymphadenopathy and multiorgan involvement. Histologically, Castleman's disease is divided into the hyalinized vascular form and a plasma cell variant, the former being more common in localized disease and the latter more common in MCD. MCD is associated with Kaposi's sarcoma herpesvirus (KSHV) infection, which is alternatively termed human herpesvirus 8 (HHV8). This virus encodes a homologue of interleukin 6 (vIL 6), which may mediate some systemic features of MCD. The diagnosis of Castleman's disease is established by biopsy and treatment is often based on published case reports only, as there are no randomized trials of therapy. Surgery has less of a role in MCD than in localized disease, but debulking by splenectomy may be useful to alleviate haematological sequelae. Systemic treatments for MCD have included chemotherapy, anti-herpesvirus treatments to reduce the KSHV viral load, highly active antiretroviral therapy (HAART) to reduce HIV viraemia and latterly monoclonal antibodies against both IL 6 and CD20. The introduction of HAART has altered the natural history of HIV infection; however, its impact on MCD is difficult to ascertain. Optimization and consensus in treatment of these patients remains a target for the future.

Aged↗
PubMed2006

Long-term survival benefit after adjuvant treatment of cutaneous melanoma with dacarbazine and low dose natural interferon alpha: A controlled, randomised multicentre trial.

In a prospective, controlled, randomised, multicentre study 252 patients with totally resected cutaneous melanoma (248 in stage II-III and 4 in stage IV) were either treated with two doses of dacarbazine (DTIC) followed by a 6-month treatment with 3 MU thrice weekly of highly purified natural interferon-alpha (n = 128; arm A) or received no adjuvant treatment (n = 124; arm B). Treatment was well tolerated. After a median follow-up of 8.5 years ITT analysis showed that the difference in survival was statistically significant with respect to melanoma-related deaths (HR = 0.65, CI = 0.46-0.97, p = 0.022) and close to significance with respect to overall survival (HR 0.71, CI 0.49-1.00, p = 0.052). The risk reduction of melanoma-associated death, calculated by Cox proportional hazards modelling, after adjusting for identified predictive variables, was almost 50% (p = 0.002). The overall efficacy of the treatment appeared to be mainly attributable to effects observed in patients with deep and/or metastasizing tumours (HR 0.60, CI 0.40-0.90, p = 0.013).

Adult↗
PubMed1989

Prenatal treatment in congenital adrenal hyperplasia due to 21-hydroxylase deficiency: up-date 88 of the French multicentric study.

A multicentric study of prenatal treatment of congenital adrenal hyperplasia (CAH) resulting from 21-hydroxylase deficiency in 43 pregnancies at risk for CAH is presented. The mothers were given dexamethasone per os, 0.5 mg either 12-hourly or 8-hourly. From the analysis of the results obtained in the present study and review of the literature, it would appear that the first condition for successful prevention of female virilization in utero (a total of 6 cases) is to start treatment as early as possible, no later than the 7th week. The dose of dexamethasone should be related to maternal size: 20 micrograms/kg/day (in 2 or 3 fractioned) doses would seem to be both efficient and safe. Adrenal suppression of both maternal and fetal adrenal function should be controlled by appropriate hormonal determinations. Finally, the advantages of early prenatal diagnosis or no prenatal diagnosis are discussed.

Adrenal Hyperplasia, Congenital↗
PubMed2003

Adherence to antiretroviral therapy and its determinants in children with human immunodeficiency virus infection: a multicentre, national study.

AIM: To investigate rates and determinants of adherence to antiretroviral therapy in Italian children infected with the human immunodeficiency virus (HIV). METHODS: An observational, cross-sectional multicentre study was performed through a structured interview with the caregivers of HIV-infected children. The interview included quantitative information on adherence in the 4 d before interview. Sociodemographic, clinical and psychosocial characteristics of children were recorded. RESULTS: 129 children (median age 96 mo) were enrolled, of whom 94 were on highly active antiretroviral therapy (HAART). Twenty-one (16%) omitted more than 5% of total doses in 4 d and were considered non-adherent. However, only 11% of caregivers reported that therapy had been administered at the correct times. No significant difference was found between age and the stage of HIV infection. Children aware of their HIV status were less adherent. Individual drugs showed a broad adherence pattern and children who received HAART were more adherent. Children receiving therapy from foster parents were more adherent than those receiving drugs from biological parents or relatives. CONCLUSIONS: Adherence is a major problem in children. Psychological rather than clinical or sociodemographic features and types of drug are major determinants of adherence.

Adolescent↗
PubMed2005

An observer-blind parallel-group, randomized, multicentre clinical and microbiological study of a topical clindamycin/zinc gel and a topical clindamycin lotion in patients with mild/moderate acne.

INTRODUCTION: A topical acne treatment in which clindamycin phosphate equivalent to 1% clindamycin is presented in a gel formulation has received marketing authorizations in a number of EU and non-EU countries. Clindamycin/zinc gel contains zinc acetate in a formulation that reduces systemic absorption of clindamycin through the skin. OBJECTIVES: To compare the efficacy and safety of a 1% clindamycin/zinc gel when applied to the face once daily or twice daily with a 1% clindamycin lotion applied twice daily for 16 weeks in patients with mild to moderate acne vulgaris. METHODS: This was a randomized, comparative, observer-blind, parallel-group, multicentre study involving 246 acne patients. RESULTS: The study demonstrated therapeutic similarity between clindamycin/zinc gel applied once and twice daily with clindamycin lotion applied twice daily. All three regimens produced a gradual and time-dependent reduction in inflamed lesions, non-inflamed lesions and overall grade. Side effects were similar and minimal, consisting predominantly of mild irritant dermatitis. All regimes produced a time-related significant reduction in skin surface and follicular Propionibacterium spp. and Micrococcaceae. The emergence of resistant strains was less than 5% and was similar with all three regimes. CONCLUSION: The equivalent efficacy and safety of clindamycin/zinc gel either once or twice daily to clindamycin lotion twice daily has been demonstrated. It is suggested that a treatment regime of one application per day may significantly enhance compliance and thus treatment success in acne patients.

Acne Vulgaris↗
PubMed2001

Use of venous thromboembolism prophylaxis for surgical patients: a multicentre analysis of practice in Spain.

OBJECTIVE: To assess the use of venous thromboembolism prophylaxis in surgical patients. DESIGN: Retrospective multicentre study. SETTING: Eight acute-care teaching hospitals with more than 400 beds, Spain. PATIENTS: Medical records of all consecutive patients undergoing operations in the general surgical and trauma and orthopaedic services during the month of April, 1997, were randomly selected. INTERVENTION: The sample size for each type of operation (general, trauma-orthopaedic) was calculated from the number of operations done at each hospital (with an absolute precision of 5%, and an alpha error of 5%) and the prevalence of the use of venous thromboembolism prophylaxis obtained from a random sample of 50 records (25 from patients in general surgery and 25 from patients in orthopaedic surgery) from each centre. MAIN OUTCOME MEASURES: Appropriate and inappropriate pharmacological prophylaxis defined according to a combination of risk categories for venous thromboembolism, doses of antithrombotic agents given, time of starting prophylaxis, and its duration. RESULTS: A total of 1848 medical records (general surgery, n = 1025; trauma-orthopaedic surgery, n = 823) were included. Physical methods (elastic stockings, intermittent pneumatic compression) were used in only 0.3% of patients. Pharmacological prophylaxis consisted of low molecular weight heparin in 99% of cases. The percentage given heparin-based prophylaxis was 54%. Overall, appropriate prophylaxis was given in 1175 patients (64%). Use of thromboprophylaxis ranged from 27% to 70% among the participating hospitals. Prophylaxis was more likely to be appropriate in orthopaedic patients (577, 70%) than in general surgical patients (598, 58%) in both the high and moderate risk categories. CONCLUSIONS: Given the large variability between the participating hospitals, more specific protocols and recommendations about prophylaxis of thromboembolism in surgical patients are needed.

Adolescent↗