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At least 1,135 records · Page 63Linked to original sources
PubMed1999

Thymosin alpha1 treatment of chronic hepatitis B: results of a phase III multicentre, randomized, double-blind and placebo-controlled study.

Previous clinical trials have suggested that thymosin alpha1 (Talpha1), an immunomodulatory peptide, may be effective in the treatment of chronic hepatitis B (CHB). The aim of this study was to determine the efficacy of Talpha1 in a multicentre, placebo-controlled and double-blind study of 97 patients with serum hepatitis B virus (HBV) DNA- and hepatitis B e antigen (HBeAg)-positive CHB. Patients who had been hepatitis B surface antigen (HBsAg) positive for at least 12 months entered a 3-month screening period prior to randomization. Forty-nine patients received Talpha1 (1.6 mg) and 48 patients received placebo, twice weekly for 6 months, and were followed-up for an additional 6 months. At inclusion, both groups were comparable for age, gender, histological grading, and aminotransferase and HBV DNA levels. A complete response to treatment, defined as a sustained serum HBV DNA-negative status (two negative results at least 3 months apart) during the 12-month study, with negative HBV DNA and HBeAg values at month 12, was seen in seven (14%) patients given Talpha1 and in two (4%) patients treated with placebo (P = 0.084). Five (10%) patients given Talpha1 and four (8%) patients given placebo exhibited a delayed response (defined as sustained serum HBV DNA negativity achieved after the 12-month study period with negative HBV DNA and HBeAg values at the last assessment). A total of 12 (25%) patients given Talpha1 and six (13%) patients given placebo showed a sustained loss of HBV DNA with a negative HBeAg value during or following the 12-month study period (P < 0.11). These results do not confirm observations of treatment efficacy reported in other clinical studies.

Adjuvants, Immunologic↗
PubMed2000

Treatment of chronic hepatitis C genotype IV with interferon-ribavirin combination in Saudi Arabia: a multicentre study.

Between 1996 and 1997, we conducted a multicentre study to assess the effect of combination therapy of interferon (IFN) + ribavirin on chronic hepatitis C genotype 4. Ninety-seven patients were enrolled. Sixty-eight patients (47 male and 21 female) were non-responders to previous therapy with IFN (Group I). Twenty-nine patients (19 male and 10 female) were new (Group II). Following treatment with IFN, 23% in Group I and 9% in Group II had a sustained biochemical response. Only 12% in Group I and 5% in Group II achieved a sustained virological response. Virus load was found to be the major factor determining response, followed by histology grading and staging. Like HCV genotype 1, HCV genotype 4 seems to have a poor response to therapy.

Adult↗
PubMed1998

Verbal autopsies for adult deaths: their development and validation in a multicentre study.

BACKGROUND: Verbal autopsy (VA) has been widely used to ascertain causes of child deaths, but little is known about the usefulness of VA for adult deaths. This paper describes the process used to develop a VA tool for adult deaths and the results of a multicentre validation of this tool. METHODS: A mortality classification was developed by including causes of death that might be arrived at by VAs and causes that are responsive to public health interventions. An algorithm was designed for each cause in the classification, based on classifying symptoms into essential, supportive and differential. A structured questionnaire designed to elicit information on these symptoms was developed in English translated into the local languages. The tool was validated on deaths occurring at hospitals in Tanzania (315 deaths), Ethiopia (249) and Ghana (232). Hospital records of all adult deaths occurring at the study hospitals from June 1993 to April 1995 were collected prospectively. Non-medical interviewers with at least 12 years of formal education conducted VA interviews. Causes of death were diagnosed by a panel of physicians and by a computerized algorithm. The validity of the VA was assessed by comparing the VA diagnoses with hospital diagnoses. RESULTS: Specificity of VAs by physicians fell below 95% only for acute febrile illness (AFI) and TB/AIDS. Sensitivity and positive predictive value (PPV), however, varied widely both across the sites and between causes. Sensitivity was > 75% for tetanus, rabies, direct maternal causes, injuries and TB/AIDS and ranged between 60% and 74% for diarrhoea, acute abdominal conditions and AFI. The PPV was > 75% for tetanus, rabies, hepatitis and injuries and ranged between 60 and 74% for meningitis, AFI, TB/AIDS and direct maternal causes. When the communicable diseases were combined in a single group, the sensitivity was 82%, specificity 78% and PPV 85%. For the group of noncommunicable diseases the corresponding sensitivity, specificity and PPV were 71%, 87% and 67%, respectively. Use of an algorithm resulted in lower sensitivity, specificity and PPV than the VAs by physician. CONCLUSION: VAs by a panel of physicians performed better than an opinion-based algorithm. The validity of VA diagnosis was highest for AFI, direct maternal causes, TB/AIDS, tetanus, rabies and injuries.

Adult↗
PubMed1998

The effects of ivermectin on onchocercal skin disease and severe itching: results of a multicentre trial.

OBJECTIVE: To determine the effects of ivermectin in annual, 3-monthly and 6-monthly doses on onchocercal skin p6isease (OSD) and severe itching. METHOD: A multicentre, double-blind placebo controlled trial was conducted among 4072 residents of rural communities in Ghana, Nigeria and Uganda. Baseline clinical examination categorized reactive skin lesions as acute papular onchodermatitis, chronic papular onchodermatitis and lichenified onchodermatitis. Presence and severity of itching was determined by open-ended and probing questions. Clinical examination and interview took place at baseline and each of 5 subsequent 3-monthly follow-up visits. RESULTS: While prevalence and severity of reactive lesions decreased for all 4 arms, those receiving ivermectin maintained a greater decrease in prevalence and severity over time. The difference between ivermectin and placebo groups was significant for prevalence at 9 months and for severity at 3 months. Differences between placebo and ivermectin groups were much more pronounced for itching. From 6 months onward, the prevalence of severe itching was reduced by 40-50% among those receiving ivermectin compared to the trend in the placebo group. CONCLUSION: This is an important effect on disease burden as severe itching is for the affected people the most troubling complication of onchocerciasis. The difference among regimens was not significant, and the recommended regimen of annual treatment for the control of ocular onchocerciasis appears also the most appropriate for onchocerciasis control in areas where the skin manifestations predominate. The final determination of the effect on skin lesions requires a longer period of study.

Adult↗
PubMed2003

Multicentre laboratory evaluation of Brugia Rapid dipstick test for detection of brugian filariasis.

A multicentre evaluation of the Brugia Rapid dipstick test was performed using 1263 serum samples in four international laboratories, i.e. T.D. Medical College (TDMC, India), National Institutes of Health (NIH, USA), Swiss Tropical Institute (STI, Switzerland) and Leiden University Medical Centre (LUMC, Netherlands). In comparison with microscopy, the dipstick demonstrated sensitivities of 97.2% (70 of 72) at TDMC, 91.6% (175 of 191) at LUMC and 100% (six of six) at STI. Sera of chronic patients showed a positivity rate of 11.3% (19 of 168) and 61.2% (71of 116) at TDMC and LUMC, respectively. All 266 sera of non-endemic normals from STI, NIH and LUMC tested negative with the dipstick. At LUMC, sera of 'endemic normals' (amicrofilaraemics with no clinical disease) from an area with approximately 35% microfilaria positivity showed 60.8% positive results (31 of 51), thus demonstrating the likelihood of many cryptic infections occurring in this population. Specificities of the test with Onchocerca volvulus sera were 98.8% (80 of 81) and 100% (10 of 10) at the NIH and STI, respectively; while specificity with Loa loa sera at the NIH was 84.6% (44 of 52). At the STI, the dipstick test also demonstrated 100% specificity when tested with 75 sera from various protozoan and helminthic infections.

Animals↗
PubMed2001

A multicentre evaluation of a new filtration protocol for leucocyte depletion of high-haematocrit red blood cells collected by an automated blood collection system.

BACKGROUND AND OBJECTIVES: A multicentre trial was set up to evaluate the performance of a new leucodepletion protocol. MATERIALS AND METHODS: Filtration at high haematocrit was started during collection of red blood cell (RBC) products by apheresis with Trima. SAG-M was added after filtration through the filter. Haematocrits and haemoglobin of the filtered RBCs were measured. Residual leucocytes were determined by Nageotte counting. RESULTS: One-hundred and forty seven procedures were carried out. The haematocrit and haemoglobin contents were 57.3 +/- 3.0% and 55.1 +/- 4.3 g/unit, respectively. All products showed low residual leucocyte levels (< or = 0.75 x 106/unit; 99.31% < 1 x 106). CONCLUSION: Immediate, on-line, high-haematocrit filtration of red cells collected on Trima resulted in leucoreduced RBCs, which met the AABB and Council of Europe criteria.

Blood Cell Count↗
PubMed2003

Storage of platelets in additive solutions: a multicentre study of the in vitro effects of potassium and magnesium.

BACKGROUND AND OBJECTIVES: In a preliminary study, the presence of potassium and magnesium in a modified synthetic medium (PAS-III) was found to have a significant influence on platelet metabolism (using apheresis-derived, as well as buffy-coat-derived platelets) when compared with standard PAS-III. The differences included reduced glycolysis, as evidenced by lower consumption of glucose and lower production of lactate, but also better preservation of pH and hypotonic shock response reactivity. The results suggested that storage in modified PAS-III containing 20% plasma was comparable to storage in standard PAS-III containing 30% plasma. To confirm the preliminary results and to evaluate the effects of different preparation protocols, an international multicentre study, which included 11 different sites, was conducted. MATERIALS AND METHODS: Platelets from 30 pools of approximately 20 buffy coat (BC) units each and 24 pooled apheresis platelet units were aliquoted for storage in plasma (reference) or synthetic medium using either a specific additive solution (PAS-III) containing 30% plasma or a modification of PAS-III containing 5.0 mm potassium and 1.5 mm magnesium (PAS-IIIM) and either 30% or 20% plasma. Units were stored at room temperature with agitation for 7 days during which in vitro testing was carried out for biochemical, haematological and functional parameters. RESULTS: Storage of platelets in PAS-IIIM resulted in a reduction in the rate of glycolysis and better retention of pH and hypotonic shock response reactivity. Storage in PAS-IIIM containing 20% plasma appeared to result in the retention of in vitro properties, similar to those observed during storage in standard PAS-III containing 30% plasma. CONCLUSIONS: The results of this study confirm the preliminary results. Similar results were seen with platelets prepared by BC and apheresis methods, despite differences in equipment, the preparation technique and in the final platelet contents achieved in the platelet units. Storage of platelets in PAS-IIIM should be considered to improve platelet function and allow plasma reduction to 20%.

Blood Component Removal↗
PubMed2002

Does treatment of varicocele improve male fertility? results of the 'Deutsche Varikozelenstudie', a multicentre study of 14 collaborating centres.

Treatment of varicocele is suggested in infertile men if sperm parameter values are abnormal. The effectiveness of the treatment with respect to fertility remains to be clarified. A multicentre, prospective randomized study on varicocele treatment in infertile men to demonstrate the superiority of sclerotization of the varicocele in preventing persistence, was started in 1995 with the collaboration of 15 German andrological centres. The primary endpoint was the incidence of pregnancy 1 year after randomisation. The number of cases needed to achieve the goal of the study was calculated at 460. However, three years after starting the study, only 67 patients had been randomized. Different reasons contributed to the poor recruitment. There was no significant increase in pregnancy rate in the treated group, compared to the controls, the confidence interval being 20.8% to 15.7%. The authors would like to encourage further collaborative study groups to start another prospective, randomized study with the aim of avoiding the costs and risks of varicocele treatment when its success remains unclear.

Female↗
PubMed2002

A retrospective study of the incidence and prognostic factors of multicentric lymphoma in dogs (1998-2000).

Sixty-three dogs with multicentric lymphoma were evaluated for risk of diseases. The greatest risk of disease concerned rottweilers as compared to other breeds (odds ratio 6.01 to 0.32-2.75, respectively). A group of 43 dogs under chemotherapy was evaluated for defining factors influencing first remission time duration and survival time. The most important factors for results of chemotherapy were response to therapy, stage and sub-stage of disease according the World Health Organization staging system at the time of diagnosis.

Animals↗
PubMed2002

Multicentric reticulohistiocytosis presenting with a rash and arthralgia.

A case of multicentric reticulohistiocytosis in a 53-year-old woman with a history of generalized cutaneous eruptions followed by arthralgia is presented. A thorough malignancy screen was performed with negative results. Treatment was commenced with oral prednisone 20 mg daily, which rapidly resulted in marked improvement of joint symptoms and resolution of self-perceived functional disability. As there was little improvement of her rash, oral azathioprine was added at 100 mg daily. Both drugs were well-tolerated and the patient was discharged from hospital on these medications. Two months later the azathioprine was reduced to 50 mg per day orally, following a small rise in hepatic transaminases. Within 4 months there had been dramatic improvement in the rash and cutaneous nodules with complete remission of the arthralgia and pruritus. During this time the oral prednisone had gradually been decreased to 10 mg daily. To date only the periungual nodules persist.

Arthralgia↗
PubMed1999

A double-blind, multicentre study to assess the tolerability and efficacy of paroxetine compared with amitriptyline in the treatment of depressed patients in Australian general practice.

OBJECTIVE: This study compared the tolerability and efficacy of paroxetine and amitriptyline in the treatment of depression in general practice. METHODS: In this double-blind, multicentre study conducted in the general practice, patients with depression (Montgomery Asberg Depression Rating Scale [MADRS] score > or = 20) who were regarded as requiring antidepressant therapy were randomly assigned to receive paroxetine (20 mg, n = 184) or amitriptyline (50-100 mg, n = 191) once daily for 9 weeks. RESULTS: More patients completed treatment with paroxetine than with amitriptyline (71.1% vs 56.1%, p = 0.009). Depression rating scores (MADRS and Clinical Global Impression [CGI]) were improved with both agents, but at week 9, paroxetine achieved more favourable scores compared with amitriptyline on MADRS (p=0.019), CGI severity of depression (p=0.044), and CGI efficacy index (p = 0.038). CONCLUSIONS: Depressed patients treated in general practice respond more quickly and are more likely to complete the treatment regimen with paroxetine than with amitriptyline.

Adult↗
PubMed2000

Clinical markers of serious illness in young infants: a multicentre follow-up study.

OBJECTIVE: To perform a multicentre follow-up study to determine if previously identified markers of serious illness in early infancy were robust and statistically reliable. METHODS: Infants aged 1 week to 26 weeks presenting to the Emergency Departments of the Royal Children's Hospital and two Melbourne metropolitan hospitals were seen over a 12-month period. Eleven clinical markers as well as their temperature were documented by nursing staff and resident medical officers. Serious illness was defined if infants had a positive body fluid bacterial culture, a positive chest X-ray or if significant treatment was required in hospital. The predictive values, sensitivity and specificity for the individual and the best combination of clinical markers were determined. RESULTS: Assessments (3806) were performed with 312 infants being assessed as seriously ill (8.2%). The combination of either drowsiness on history or examination, pallor on history or examination, breathing difficulty (chest wall recession), temperature above 38 degrees C and a lump being present, identified 82.5% of all babies deemed subsequently to be seriously ill. The positive predictive value of an infant who was febrile, drowsy and pale on examination was 70.7% (previous study 74%). CONCLUSIONS: This study confirmed the high individual predictive value of arousal variables, pallor, and chest wall recession, especially when associated with fever, reaffirming their utility in the recognition of serious illness in infants under 6 months of age.

Biomarkers↗
PubMed2001

HHV-8 infection status of AIDS-unrelated and AIDS-associated multicentric Castleman's disease.

Multicentric Castleman's disease (MCD) is a clinicopathologically defined entity characterized by systemic lymphadenopathy with unique pathomorphology such as angiosclerosis, blood vessel proliferation in and around follicles, and plasmacytosis. While its pathogenesis has remained unclarified for many years, identification of the human herpesvirus 8 (HHV-8) in at least some MCD cases has opened new perspectives in this field. Because previous reports have described many inconsistencies regarding HHV-8 positivity in MCD, we intended to clarify this issue by the introduction of more convincing methodologies. For this investigation, we introduced two antibodies produced in our laboratories that recognize a latent gene product ORF73 and a lytic gene product ORF59, together with two well-recognized methods, in situ hybridization for the detection of lytic phase transcript T1.1/nut-1, and genomic polymerase chain reaction (PCR). Eighty-two cases of MCD were collected from Japan (n = 75) and France (n = 7). In three cases, the patients were suffering from acquired immunodeficiency syndrome (AIDS). Immunohistochemistry and in situ hybridization showed identical results: only three out of 82 cases were positively stained, and all the positive cases were found to be the patients with AIDS. Genomic PCR was done in 43 cases, and only one case produced positive results: the only AIDS case among the 43 cases studied by genomic PCR. Histopathologically, the HHV-8-positive cases showed the highest intensity of angiosclerosis and germinal center / perifollicular vascular proliferation, while plasmacytosis was not severe in the HHV-8-positive cases. Some of the HHV-8-negative MCD cases displayed similar histopathology, but at a far less intense level, except for the plasmacytosis. These results suggest that: (i) all three of the HHV-8-positive MCD patients in the present group are the patients with AIDS; and (ii) HHV-8-positive MCD patients develop typical but marked angiosclerosis and vascular proliferation that might be differentiated from HHV-8-negative MCD patients, who showed far less intense changes.

Acquired Immunodeficiency Syndrome↗
PubMed1999

Effects of anti-emetic drug (tropisetron) on quality of life during chemotherapy: use of a diary-type questionnaire and application of summary measures for assessment in a randomized, multicentre study. Joint Research Group for Tropisetron Double-Blind Comparative Study.

The role of tropisetron as an anti-emetic drug in the prevention of delayed nausea and vomiting remains unclear. Therefore, effectiveness of tropisetron in patients receiving cancer chemotherapy was evaluated by application of summary measures using a quality of life (QOL) questionnaire. The diary-type QOL self-rating questionnaire was constituted by seven scales. A double-blind randomized, multicentre study was performed in 33 hospitals. Quality of life was measured in 98 patients. Patients receiving cisplatin were randomized to group T (administration of tropisetron before and 4 days after cisplatin treatment) and group P (administration of tropisetron before cisplatin treatment and followed by placebo for 4 days). The rate of complete protection from delayed emesis in the groups T and P was 46.3 and 36.5%. All scales, except social wellbeing changed immediately in both groups and reached a nadir on days 2-3, after that returning to the control levels during 2 weeks after cisplatin treatment. Group T was significantly better than group P in physical wellbeing, mental wellbeing, functional wellbeing and global QOL scores summarized by area under the curve and Difmax (maximum differences of QOL scales' score from the best score throughout the entire period). These results indicate that continuous administration of tropisetron could contribute to preventing patient QOL influenced by cisplatin treatment, and the combined use of summary measures may be useful for the evaluation of QOL in cancer clinical trial.

Adult↗
PubMed2003

Fluoropolymer coated Dacron or polytetrafluoroethylene for femoropopliteal bypass grafting: a multicentre trial.

BACKGROUND: This trial was designed to compare graft patency between expanded polytetrafluoroethylene (PTFE) and fluoro-polymer coated Dacron for femoropopliteal bypass in patients in whom saphenous vein was unavailable. METHODS: A multicentre prospective trial randomized 129 patients (74 men, 55 women) who underwent femoropopliteal bypass using either a PTFE or fluoropolymer coated Dacron graft. The indication for operation was disabling claudication in 68 (52.7%) and critical limb ischaemia in 61 (47.3%) patients. Distal anastomosis was above the knee in 76 (58.9%) and below the knee in 53 (41.1%) patients. RESULTS: Primary patency at 6, 12 and 24 months was 71%, 56% and 47% for PTFE and 50%, 36% and 36% for fluoropolymer coated Dacron (P = 0.002), respectively. Secondary patency at 6, 12 and 24 months was 77%, 60% and 48% for PTFE and 66%, 49% and 46% for fluoropolymer coated Dacron (P = 0.13), respectively. The superior primary patency of PTFE over fluoropolymer coated Dacron was most evident in patients with poor prognostic indicators for graft survival: critical limb ischaemia (P = 0.001); below-knee anastomosis (P = 0.01); and smaller (6 mm) diameter grafts (P = 0.002). Graft thrombosis developed in the first month in 22 of 61 (36%) patients receiving fluoropolymer coated grafts compared to six of 68 (8.8%) patients receiving PTFE, which accounts for the difference in primary patency. Successful thrombectomy in 10 of the 22 fluoropolymer coated grafts resulted in similar secondary patency. CONCLUSION: Polytetrafluoroethylene has superior primary patency and similar secondary patency to fluoropolymer coated Dacron. These results support the preferential use of PTFE in patients with critical limb ischaemia, especially when a below-knee distal anastomosis and smaller diameter graft is required.

Aged↗
PubMed2003

Analgesic efficacy and tolerability of ketoprofen lysine salt vs paracetamol in common paediatric surgery. A randomized, single-blind, parallel, multicentre trial.

BACKGROUND: In this study, we compared the analgesic efficacy of ketoprofen lysine salt (OKi) suppositories) vs paracetamol, in children undergoing minor surgery. We also studied the side-effects of the treatment. METHODS: Eighty-five children of both sexes, aged 6-14 years, were enrolled in a multicentre, randomized, single-blind, parallel-group study design. In all patients postsurgical pain was evaluated by visual analogue scale (VAS) and degree of distress (night-time awakening, crying, behaviour and defence posture). RESULTS: Ketoprofen lysine was more effective than paracetamol in reducing postoperative pain (P = 0.008) with earlier onset and longer duration (8 h) of the antinociceptive effect. Evaluation of area under the curve, an aggregated measure of VAS, and of distress, confirm the time profile of pain reduction. No adverse effects related to the treatment were observed. CONCLUSIONS: Ketoprofen lysine salt can be considered a potent therapeutic approach to control postsurgery pain in children, and an alternative to other established drug regimens.

Acetaminophen↗
PubMed1997

Transurethral needle ablation of the prostate for the treatment of benign prostatic hyperplasia: a collaborative multicentre study.

OBJECTIVE: To assess the efficacy and safety of transurethral needle ablation of the prostate (TUNA) for patients with symptomatic benign prostatic hyperplasia (BPH) in a multicentre trial. PATIENTS AND METHODS: Seventy-six patients were recruited from five centres; all were treated with the TUNA system consisting of a powered radiofrequency generator and a TUNA catheter. The patients were evaluated prospectively using the international prostate symptom score (IPSS), uroflowmetry, quality-of-life score, and other variables, and followed for a mean of 12 months after treatment. RESULTS: Sixty-eight patients were available for follow-up: TUNA produced significant improvements in the IPSS (median 22 before, to 7.5 after treatment). urinary flow rate (mean 8.7 before, to 11.6 mL/s after treatment) and quality-of-life score (median 5 before, to 2 after treatment) at 12 months. CONCLUSIONS: If these early promising results are maintained. In the medium to long term, TUNA therapy will be a useful low-morbidity alternative for patients with symptomatic BPH.

Aged↗
PubMed1998

Long-term treatment with desmopressin in children with primary monosymptomatic nocturnal enuresis: an open multicentre study. Swedish Enuresis Trial (SWEET) Group.

OBJECTIVE: To study the long-term efficacy and safety of desmopressin treatment in children with primary monosymptomatic nocturnal enuresis. PATIENTS AND METHODS: Children (aged 6-12 years) with nocturnal enuresis were recruited into an open multicentre trial. All children underwent an observation period of 4 weeks before starting a 6-week dose-titration period with desmopressin. If the number of wet nights decreased by more than half during medication, they began long-term treatment on 20-40 microg desmopressin. To test for cure and avoid overtreatment, the medication was interrupted for one week every third month. RESULTS: Of the 399 children forming the intention-to-treat cohort, 245 halved their number of wet nights and started long-term treatment. During the periods off medication, 77 children were dry and at the end of the study another 73 (still on medication) reduced the number of wet nights to < or =10% of that during the observation period. A further 51 children halved the number of wet nights compared with the observation period. No serious adverse events occurred. CONCLUSION: Long-term treatment with nasal desmopressin at a main dose of 40 microg is an effective and safe treatment for monosymptomatic nocturnal enuresis.

Administration, Intranasal↗