Objectives: To develop an in-house training program of Good Clinical Practice (GCP) for the whole clinical team and to evaluate the effect of the program on the personnel's knowledge on GCP.
Background: GCP is a set of ethical and scientific quality requirements to which clinical trials must adhere. Since it is included in the legislation of the member states of European Union, it represents a challenge for research, and therefore more GCP training is needed.
We tested the tissue reactions and mechanical strength of a novel biodegradable craniomaxillofacial plating system, Inion CPS, in the course of degradation. Plates and screws composed of L-lactide, D-lactide and trimethylene carbonate were implanted to the mandible and dorsal subcutis of 12 sheep. The animals were sacrificed at 6-156 weeks.
View Article and Find Full Text PDFThe study was aimed to test the mechanical strength, structural stability, and tissue reactions of optically amorphous and crystalline polyetheretherketone (PEEK) plates during a 3-year follow-up in vivo and in vitro. The injection-moulded PEEK plates were implanted to the dorsal subcutis of 12 sheep, which were sacrificed at 6-156 weeks. Thereafter, the plates were subjected to tensile tests, and levels of crystallinity were assessed by differential scanning calorimetry (DSC).
View Article and Find Full Text PDFBackground: Oxidative modification of low-density lipoprotein (LDL) is an important contributor to atherosclerosis. Also, oxidized LDL is suspected to cause accumulation of asymmetric dimethylarginine (ADMA), an endogenous competitive nitric oxide synthase inhibitor, which is suggested to be an independent risk factor for atherosclerosis. This study was performed to evaluate how plasma ADMA is related to plasma nitric oxide production, oxidized LDL and ex vivo susceptibility of LDL to oxidation in mildly hypercholesterolemic otherwise healthy subjects.
View Article and Find Full Text PDFInt J Oral Maxillofac Surg
August 2006
The aim of this study was to assess degradation of a novel bioactive guided tissue regeneration (GTR) membrane and to quantify the concurrent tissue responses. Pieces of membrane composed of poly-l-lactide, poly-d,l-lactide, trimethylenecarbonate and polyglycolide were dipped into an N-methyl-2-pyrroline (NMP) solution and implanted in the mandibles of 10 sheep. The animals were sacrificed at 6-104 weeks.
View Article and Find Full Text PDFBackground: Probiotic bacteria have beneficial effects on the immune system and gastrointestinal tract, but the impacts of their long-term consumption on health and growth in early infancy are not well documented. The aim of this study was to evaluate the influence of Lactobacillus rhamnosus GG (LGG)-enriched formula on growth and faecal microflora during the first 6 months of life in normal healthy infants.
Materials And Methods: One hundred and twenty healthy infants (up to 2 months) received LGG-supplemented formula or regular formula in a double-blind, randomized manner until the age of 6 months.
Objectives: To establish whether the relationship between interleukin-6 (IL-6) and plasma lipid and C-reactive protein (CRP) concentrations is different in Finnish nonagenarians than in middle-aged subjects with lower inflammatory status.
Design: Cross-sectional.
Setting: Observational cohort study concentrating on the oldest old.
Chitosan is a deacetylated product of chitin. Microcrystalline form of chitosan has a large adsorption area claimed to decrease gastrointestinal absorption of cholesterol. However, the long-term effect of chitosan on plasma lipids is variable, the averaged influence being negligible or lacking in mildly-to-moderately hypercholesterolaemic (4.
View Article and Find Full Text PDFAsymmetric dimethylarginine (ADMA) is an endogenous nitric oxide synthase inhibitor that participates in the regulation of vasodilatory function and is also linked to hypertension, whereas its stereoisomere, symmetric dimethylarginine (SDMA), is biologically inactive. Dietary components influence vascular functions and a high-fat meal seems to increase postprandial plasma ADMA levels. However, it has not been published whether diet influences plasma ADMA levels.
View Article and Find Full Text PDFObjective: To evaluate the long-term effect of microcrystalline chitosan (MCC) on plasma lipids, especially the concentration of low-density lipoprotein (LDL) cholesterol, in subjects with a moderately increased concentration of plasma total cholesterol.
Methods: A total of 130 middle-aged men and women without severe disease and with a total cholesterol of 4.8-6.
Chitosan (CAS 9012-76-4) is derived by alkaline deacetylation from chitin, an abundant polymeric product of natural biosynthesis especially in crustaceans. It is available in a primary, unorganised structure, but also in a microcrystalline form. As a dietary supplement, chitosan has been claimed to control obesity and to lower serum cholesterol.
View Article and Find Full Text PDFMethods Find Exp Clin Pharmacol
June 1999
Peroral microcrystalline chitosan (MCCh; 3 capsules, each 400 mg b.i.d.
View Article and Find Full Text PDFErythromycin acistrate (EA)--a new ester of erythromycin--was compared with erythromycin base as enterocoated pellets in capsules (EB enterocapsules) and enterocoated tablets of erythromycin base (EB enterotablets) in the treatment of respiratory tract infections. The present double-blind, multicentre study, conducted in eight occupational health centres, included 474 patients; 236 treated with EA, 117 with EB enterocapsules and 121 with EB enterotablets. The diagnoses included tonsillitis, sinusitis, otitis media, bronchitis and pneumonia.
View Article and Find Full Text PDFEur J Clin Pharmacol
July 1987
We have treated ninety-five patients undergoing surgical removal of third molar with diclofenac or placebo, administered double-blind either pre- or postoperatively. Postoperative pain was recorded hourly for the first 8 h using a 100 mm visual analogue scale. Preoperative administration of diclofenac produced more effective pain relief than either postoperative administration or placebo.
View Article and Find Full Text PDFActa Anaesthesiol Scand
November 1986
The effects of a prostaglandin synthesis inhibitor (diclofenac, Voltaren) and an opiate (oxycodone, Oxanest) on postoperative pain were compared. Included in the study were 85 candidates for various operations. Patients requesting an analgesic were given either 75 mg of diclofenac or 10 mg of oxycodone as an intramuscular injection.
View Article and Find Full Text PDFClin Rheumatol
March 1984
The efficacy and tolerability of 100 mg suppositories of diclofenac sodium (Voltaren) and indomethacin were investigated in relieving symptoms of rheumatoid arthritis. Thirty patients were included in a double-blind, cross-over study for two weeks - six days with diclofenac suppositories, following two days with placebo and six days with indomethacin. Diclofenac sodium and indomethacin were given in random order.
View Article and Find Full Text PDFDiclofenac sodium was investigated in the treatment of juvenile rheumatoid arthritis (JRA). The pharmacokinetics of diclofenac in children aged 2-7 was assessed. Seven patients were included in a single-dose trial to determine plasma levels and renal elimination of diclofenac sodium.
View Article and Find Full Text PDFEur J Obstet Gynecol Reprod Biol
September 1981
The efficacy of diclofenac sodium was investigated in the painful symptoms of primary dysmenorrhea and in reducing menstrual bleeding. Thirty-five nulliparous women (17-28 yr of age) were included in a double-blind cross-over study for four menstrual periods, two periods with diclofenac sodium and two periods with placebo. The diclofenac sodium treatment (total of 58 periods) reduced the pain significantly in comparison with placebo (57 periods), as evaluated by subjective rating (P less than 0.
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