Search results for "Cross-Over Studies"
showing 10 items of 212 documents
Treatment of epistaxis in hereditary hemorrhagic telangiectasia with tranexamic acid - a double-blind placebo-controlled cross-over phase IIIB study.
2014
Abstract Introduction Epistaxis is the most frequent manifestation in hereditary hemorrhagic telangiectasia, in which no optimal treatment exists. It can lead to severe anemia and reduced quality of life. Positive effects of tranexamic acid, an antifibrinolytic drug, have been reported on epistaxis related to this disorder. We sought to evaluate the efficacy of treating nosebleeds in hereditary hemorrhagic telangiectasia with tranexamic acid. Materials and Methods In a randomized, double-blind, placebo controlled, cross-over phase IIIB study, 1 gram of tranexamic acid or placebo was given orally 3 times daily for 3 months for a total of 6 months. Results 22 patients were included in the int…
The Effect of Adaptive Nonlinear Frequency Compression on Phoneme Perception
2017
Purpose This study implemented a fitting method, developed for use with frequency lowering hearing aids, across multiple testing sites, participants, and hearing aid conditions to evaluate speech perception with a novel type of frequency lowering. Method A total of 8 participants, including children and young adults, participated in real-world hearing aid trials. A blinded crossover design, including posttrial withdrawal testing, was used to assess aided phoneme perception. The hearing aid conditions included adaptive nonlinear frequency compression (NFC), static NFC, and conventional processing. Results Enabling either adaptive NFC or static NFC improved group-level detection and recognit…
Influence of green and black tea on folic acid pharmacokinetics in healthy volunteers: potential risk of diminished folic acid bioavailability
2008
Previous in vitro studies using Caco-2 cell monolayers suggested a possible interaction between green and black tea and folic acid at the level of intestinal absorption. The main purpose of the present study was to investigate a possible pharmacokinetic interaction between tea and folic acid in healthy volunteers. In an open-labeled randomized cross-over study, the pharmacokinetic interaction between tea and folic acid (0.4 mg and 5 mg) was investigated in healthy volunteers. Water was used as the reference drink. Subjects ingested 0.4 mg folic acid tablets with water, green or black tea (0.3 g extract/250 ml) or 5 mg folic acid tablets with water or green tea (0.3 g extract/250 ml). Blood …
Dynamics of BCR-ABL mRNA expression in first-line therapy of chronic myelogenous leukemia patients with imatinib or interferon alpha/ara-C.
2003
We sought to determine dynamics of BCR-ABL mRNA expression levels in 139 patients with chronic myelogenous leukemia (CML) in early chronic phase, randomized to receive imatinib (n=69) or interferon (IFN)/Ara-C (n=70). The response was sequentially monitored by cytogenetics from bone marrow metaphases (n=803) and qualitative and quantitative RT-PCR from peripheral blood samples (n=1117). Complete cytogenetic response (CCR) was achieved in 60 (imatinib, 87%) vs 10 patients (IFN/Ara-C, 14%) after a median observation time of 24 months. Within the first year after CCR, best median ratio BCR-ABL/ABL was 0.087%, (imatinib, n=48) vs 0.27% (IFN/Ara-C, n=9, P=0.025). BCR-ABL was undetectable in 25 c…
New levothyroxine formulation meeting 95–105% specification over the whole shelf-life: results from two pharmacokinetic trials
2016
Small levothyroxine (L-T4) dose changes can lead to significant clinical effects. To ensure thyroid hormone levels are safely maintained, authorities are increasingly adopting stricter potency specifications for L-T4, the most stringent of these being 95-105% of the labeled dose over the whole shelf-life. Levothyroxine sodium (Euthyrox, Eutirox, Lévothyrox ) has been reformulated, and two studies performed, to ensure bioequivalence to the currently marketed formulation and dosage form proportionality of the new formulation.The bioequivalence study was an open-label, randomized, single-dose, two-period, two-sequence crossover comparing the highest dosage strengths of the currently marketed a…
Anterior limbic alpha-like activity: a low resolution electromagnetic tomography study with lorazepam challenge
2005
Summary Objective To verify findings of an independently regulated anterior limbic alpha band source. Methods In a randomised cross-over study, the spontaneous EEG was recorded in nine healthy subjects after i.v. lorazepam or placebo. Intracerebral current densities within classical frequency bands were estimated with low resolution electromagnetic tomography [LORETA] and compared between groups with t -statistical parametric mapping [SPM{ t }]. A region-of-interest [ROI] based method was used to compare frontal and occipital alpha band activity changes. Results Irrespective of treatment group, local maxima of alpha band power were localised both in the occipital lobe, Brodman area [BA] 18,…
Platelet aggregation, ATP release and cytoplasmic Ca2+ movement: the effects of cloricromene.
1994
A placebo-controlled, double-blind, randomized, cross-over study was performed in 24 healthy volunteers. 12 volunteers received Cloricromene (100mg gastroresistant capsules twice a day) for 7 days, the other volunteers received identical placebo capsules. Subsequently, after a 7-day wash-out period, at day 15, each subject received the other treatment. Blood samples were taken on days 1 and 15 (1st day of each treatment) as well as on days 7 and 21 (7th day of each treatment) before the morning drug administration and 2 and 4 hours later. Platelet aggregation and ATP secretion were studied in whole blood (WB) using ADP and collagen as stimulating agents. Ca2+ fluxes were studied in aequorin…
Relationship between rheological properties, in vitro release and in vivo equivalency of topical formulations of diclofenac.
2019
Determination of bioequivalence remains a challenge in generic topical drug development. To support pharmacokinetic studies, strategies to demonstrate microstructure sameness of the products being compared include in vitro evaluations, such as the comparison of rheological properties, droplet size and in vitro release rates. Nevertheless, defining the appropriate acceptance range to consider equivalence between test and reference formulation is complex. To shed more light into this issue, in vitro release and rheological properties were compared to in vivo bioequivalence data (systemic blood measurements within a clinical trial) after topical application of a single dose. Test and reference…
Comparisons of Musculoskeletal Complaints and Data Entry Between a Sitting and a Sit-Stand Workstation Paradigm
2009
Background: Seated working positions are often regarded as a cause for discomfort in the musculoskeletal system. Performing work in different working positions—that is, alternating between sitting and standing (sit-stand workstation paradigm)—could help reduce physical complaints. Objective: The questions were whether performing office work partly in a standing position leads to reduced complaints and whether standing would change the efficiency of data entry office work. Method: We investigated the effect of a sit-stand workstation paradigmd during experimental data entry office work on physical and psychological complaints and data entry efficiency by conducting a randomized controlled t…
Prospective, cross-over, single-center trial comparing oral double-balloon enteroscopy and oral spiral enteroscopy in patients with suspected small-b…
2011
BACKGROUND AND STUDY AIMS: Spiral enteroscopy is a new, promising rapid enteroscopy technique. A prospective cross-over study was carried out to compare this new method with the established technique of double-balloon enteroscopy (DBE). PATIENTS AND METHODS: From an initial group of 18 patients with suspected mid-gastrointestinal bleeding due to vascular malformations but no previous history of small-bowel or colonic surgery, 10 patients (mean age 69 years) completed the study. Patients underwent both enteroscopy techniques with an oral approach, in a randomized sequence. The deepest point reached during advancement in the first enteroscopy was marked with India ink. The primary end point o…