Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “efficacy determination”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 127 records · Page 7Linked to original sources
PubMed2002

Novel camptothecin derivative BNP1350 in experimental human ovarian cancer: determination of efficacy and possible mechanisms of resistance.

The novel camptothecin derivative BNP1350 (7-[2-trimethylsilyl)ethyl]-20(S)-camptothecin), also known as Karenitecin, has been developed for superior oral bioavailability and increased lactone stability. In our study, we describe the antiproliferative effects of BNP1350, SN-38 and topotecan in 4 human ovarian cancer cell lines. BNP1350 was found to be slightly more potent than SN-38 (p<0.01) and was considerably more potent than topotecan (p<0.01). We extended these studies to well-established human ovarian cancer xenografts in which we compared the growth inhibition induced by BNP1350 with that of topotecan given in equitoxic schedules. The growth inhibition in all 3 xenografts induced by BNP1350 was > or =75%, which was significantly better than that resulting from topotecan (p<0.05). We then selected BNP1350-resistant variants of the A2780 human ovarian cancer cell line, 2780K4 (resistance factor: 41) and 2780K32 (resistance factor: 90), to analyze possible resistance mechanisms. These variants exhibited cross-resistance against all camptothecins tested. In comparison with 2780K4 cells, 2780K32 cells were relatively more resistant against SN-38, topotecan, DX-8951f and BNP1350. In addition, 2780K32 cells were highly cross-resistant against mitoxantrone. In both 2780K4 and 2780K32, the amount of topoisomerase I was not changed but the catalytic activity was reduced. Furthermore, 2780K32 cells clearly overexpressed the breast cancer resistance protein (BCRP), as demonstrated for both the gene and the protein. In contrast to topotecan, BNP1350 proved not to be a good substrate for BCRP. Overall, we conclude that BNP1350 offers advantages over topotecan expressed by high efficacy in experimental human ovarian cancer and poor affinity for BCRP.

ATP Binding Cassette Transporter, Subfamily G, Mem↗
PubMed2006

A single center, randomized, comparative, prospective clinical study to determine the efficacy of the VelaSmooth system versus the Triactive system for the treatment of cellulite.

BACKGROUND AND OBJECTIVES: One area of cosmetic concern for women of all races is the unsightly appearance of cellulite in the buttocks area and lower extremities. Two modern technological advances claim to improve cellulite and provide reproducible results, TriActive and VelaSmooth. The TriActive laser is intended to reduce the appearance of cellulite through the combination of low-energy diode laser, contact cooling, suction, and massage. The VelaSmooth is based on a combination of two different ranges of electromagnetic energy: infrared light and radio frequency (RF) combined with mechanical manipulation of the skin. This single center study was designed to evaluate the efficacy of the VelaSmooth versus TriActive in the reduction of the appearance of cellulite. STUDY DESIGN/MATERIALS AND METHODS: Twenty female patients were treated twice a week for 6 weeks with the randomization of TriActive on one side and VelaSmooth on the other side. Patients were evaluated with photographs and circumferential thigh measurements before treatment and after the final treatment. RESULTS: Although there was improvement in the reduction of cellulite for each device individually, there was no significant difference between VelaSmooth or TriActive devices in the following categories: reduction of thigh circumference, photographic evaluation, and perceived change in before and after photographic grading. There was a statistically significant increase in the incidence of post-treatment bruising with the VelaSmooth compared to TriActive. CONCLUSIONS: In conclusion, both the TriActive and VelaSmooth provide improvement of cellulite. When comparing differences in efficacy, the average mean percent change calculated was roughly the same for both treatments and showed no statistical difference.

Adipose Tissue↗
PubMed1997

The utility of meta-analysis in the determination of efficacy of treatment in aphasia: a reply to Robey (1994).

In response to Robey (1994) we argue that his judgment of our study and conclusions (Whurr, Lorch, & Nye, 1992) are inaccurate. We point out that our study was in fact an analysis of the effects of treatment for aphasic patients. Further, the results obtained in Robey's analysis, though obtained via a different strategy of analysis, yielded essentially the same degree of overall treatment outcome effect. Thus, we conclude that while Robey does provide a different model of effect size data organization and measurement, the results are no different and do not in fact contradict our data.

Aphasia↗
PubMed1992

A randomized prospective clinical trial to determine the efficacy of interferon-gamma in severely injured patients.

Many aspects of the normal immune response are depressed after severe injury. Reduced monocyte human leukocyte antigen-DR (HLA-DR) levels have closely correlated with the development of major infection. After a pilot study with recombinant interferon-gamma (rIFN-gamma) showed restoration of depressed HLA-DR levels after major injury, a multicenter, prospective, randomized, double-blind trial was conducted. Two hundred thirteen trauma patients who were at high risk of infection received either placebo or rIFN-gamma (100 micrograms) subcutaneously each day for 10 days after admission. One hundred ninety-three patients were evaluable with respect to primary end points. Patients treated with rIFN-gamma were older (p = 0.10) and had more severe modes of injury (p = 0.02). By the third day, both monocyte HLA-DR antigen expression and outcome predictive score were significantly better in the rIFN-gamma-treated group than in the placebo group (p = 0.0001 and p = 0.0006, respectively). Nine deaths occurred in patients treated with rIFN-gamma compared with 12 deaths in the placebo group (p = 0.46). Major infections requiring surgical drainage or debridement occurred in 17 patients treated with rIFN-gamma compared with 22 treated with placebo. No difference between treatment arms was noted in overall major or minor infection rates, but there were fewer severe infections that required reoperation or computer tomographic-guided drainage in patients receiving IFN-gamma. While these results suggest that rIFN-gamma may be useful in some aspects of infection in the patient with severe trauma, a larger trial with longer treatment will be needed to prove the comprehensive value of rIFN-gamma.

Adult↗
PubMed1984

In vivo determination of efficacy of pyrazoloquinolinones at the benzodiazepine receptor.

The pyrazoloquinolinones CGS 9896, CGS 9895 and CGS 8216 potently displace the benzodiazepines from their CNS binding site in vitro but have been reported to display agonist, partial agonist and antagonist activity respectively in a number of in vivo tests in rats. We found CGS 9896 to have only weak antipentylenetetrazole activity in mice at doses which produced near maximal displacement of [3H]flunitrazepam in vivo and were not able to detect any antipentylenetetrazole activity of CGS 9895. However, CGS 9895 blocked the anticonvulsant effect of diazepam at doses closely related to those which inhibited the in vivo binding of [3H]flunitrazepam and CGS 9896 also showed some reversal of the antipentylenetetrazole action of diazepam. This is consistent with the notion that CGS 9896 is a partial agonist and CGS 9895 an antagonist at the benzodiazepine receptor.

Animals↗
PubMed1991

Determining therapeutic efficacy in recurrent herpes labialis by lesion size analysis.

We devised an experimental model for the analysis of therapeutic efficacy of topical medications for recurrent herpes labialis with a double-blind, placebo-controlled format. Rigid prestudy screening evaluations allowed the enrollment of a homogeneous starting population with characteristic herpetic reactivation in an early stage. Using precise measurements of lesion area for a 5-day period, we evaluated the effects of a novel medication containing tannic acid, which has demonstrated impressive inhibitory effects on herpes simplex virus in many recent studies, and salicylic acid, which has rapid absorption kinetics and substantial topical anti-inflammatory and keratin-disrupting properties. Using parametric and nonparametric tests, we studied differences in mean lesion size and used these measurements to evaluate objective and clinically applicable improvement criteria. Although there were no significant differences in mean lesion size at presentation (day 1) between the active medication and placebo groups, the former demonstrated significantly smaller lesions at days 2 through 5 (p less than 0.05). By day 5, 10 of 14 treated subjects showed improvement as defined by a 25% reduction in lesion size compared with day 1, in contrast to only 2 of 12 subjects in the placebo group (p = 0.0079, Fisher's Exact Test). This model can be employed in the evaluation of topical antiviral agents for herpes labialis in a healthy population, because it standardizes criteria for subject enrollment and provides objective and reproducible measurements of therapeutic efficacy.

Antiviral Agents↗
PubMed1993

Pilot trial to determine the efficacy of a low dose of fish oil in the treatment of angina pectoris in the geriatric patient.

23 geriatric patients completed a single-blind placebo controlled, crossover trial using fish oil as adjunctive therapy for stable angina pectoris. The results indicated a significant reduction in the number of anginal attacks, as well as a significant reduction in the consumption of sublingual isosorbide dinitrate tablets. A possible prolonged carry over effect of fish oil was noted after crossover from the active substance to placebo.

Aged↗
PubMed1996

Drug therapy for vertebral fractures in osteoporosis: evidence that decreases in bone turnover and increases in bone mass both determine antifracture efficacy.

The conventional belief is that osteopenia is the major cause of vertebral fractures and that drug therapy must induce a substantial increase in vertebral bone mineral density (BMD) before the vertebral fracture rate (VFR) is decreased. We hypothesized that the increased bone turnover in osteoporosis also is a major cause of vertebral fractures because of its adverse effects on the microarchitecture of the vertebrae and, thus, that normalization of bone turnover by antiresorptive drug therapy will decrease VFR substantially. This hypothesis is supported by our reanalysis of data from previous clinical trials with fluoride and with estrogen therapy in postmenopausal osteoporotic women. As evident from computer-generated three-dimensional graphic plots of data from osteoporotic women treated with placebo, VFR increased as bone turnover increased or as vertebral BMD decreased. Estrogen therapy decreased the bone turnover rate to normal and eliminated the relationship between VFR and bone turnover, whereas the inverse relationship with vertebral BMD persisted. In osteoporotic women treated with fluoride, VFR decreased as vertebral BMD increased, provided that patients with high (toxic) serum fluoride levels were not included in the comparison. Over the range of values in the data set, increased vertebral BMD and decreased bone turnover had approximately equal effects in decreasing VFR. Thus, both formation-stimulating and resorption-inhibiting drugs can substantially decrease VFR but do so by different mechanisms.

Bone Density↗
PubMed2004

The methodology for determining the efficacy of antibody-mediated immunity.

The basic method for evaluating the efficacy of antibody-mediated immunity (AMI) dates from the 1890s and involves the administration of specific Ab to an immunologically naïve host followed by microbial or toxin challenge. Other methods used to evaluate AMI involve correlating the presence of specific Ab with resistance to microbial disease and associating susceptibility to certain microbes with host immunoglobulin deficits. Unfortunately, each method has theoretical and practical problems that limit their usefulness when negative results are obtained. The application of hybridoma technology to investigate the efficacy of AMI has shown that it is possible to generate protective monoclonal antibodies even to microbes for which the standard methodologies indicate no role for AMI. Furthermore, studies with monoclonal antibodies suggest various explanations for the inability of standard methods to demonstrate the potential efficacy of AMI for certain pathogens.

Animals↗
PubMed2006

Characterization of methods for determining sterilization efficacy and reuse efficiency of oxygen biosensor multiwell plates.

High-throughput screening (HTS) assays based upon fluorometric detection of oxygen consumption in microtiter plates were primarily developed for applications in drug discovery and ecotoxicology but have recently been adopted for use in microbial community-level physiological profiling assays (CLPP). The widespread use of oxygen biosensor systems for CLPP applications has, however, been hindered by the relatively high cost of oxygen biosensor reagent systems and limited access to microplate fluorometer instrumentation platforms. The ability to recycle and reuse oxygen biosensor system plates would expand their utilization for CLPP assays and other research applications in microbial ecology. Here, the efficacy and cost effectiveness of multiple procedures for sterilization of Oxygen Biosensor System (OBS; BD Biosciences) plates for reuse was evaluated. OBS plates were sterilized using ethylene oxide, ultraviolet radiation, and bleach treatments, then evaluated for biosensor response and plate life-cycle performance. Of the sterilization methods tested, ethylene oxide sterilization was most effective based on its low cost, high sterilization efficacy, and minimal impact upon OBS plate response.

Biosensing Techniques↗
PubMed2000

G(i1) and G(oA) differentially determine kinetic efficacies of agonists for kappa-opioid receptor.

We examined the diversity of single receptor function by measuring receptor-G protein coupling in the baculovirus-Sf21 expression system. In comparative studies using Sf21 cell membranes expressing kappa-opioid receptor (KOR) plus Galpha(i1)beta(1)gamma(2) or KOR plus Galpha(oA)beta(1)gamma(2), there was no significant difference between both preparations in the K(i) values of various kappa-opioid ligands for the displacement of [(3)H]U69593 binding. However, a marked difference in the rank order of agonists to stimulate [(35)S]GTPgammaS binding was observed between both preparations. These findings suggest that agonist efficacy is dependent on the population of different G proteins expressed in various tissues.

Animals↗
PubMed1979

A prospective randomized study to determine the efficacy of steroids in treatment of croup.

We evaluated the use of dexamethasone in the management of acute laryngotracheobronchitis (croup). Thirty patients, ranging in age from eight to 60 months, were evaluated in a prospective, double-blind study. Patients received dexamethasone, 0.3 mg/kg at the time of admission and a similar dose 2 hours later, and were compared with a placebo group receiving saline. Sixteen patients received dexamethasone and 14 patients received the placebo. Severity of each group was scored by a standardized system. Patients receiving dexamethasone had a mean admission score of 8.46 points; patients receiving placebo, 8.14. Twenty-four hours after admission the patients in the treatment group had a mean score of 1.19 as contrasted with a score of 5.58 for the placebo group (P less than 0.01). We concluded that dexamethasone when administered in adequate dosage by an intramuscular route hastens the recovery of infants and children with acute uncomplicated croup.

Child, Preschool↗
PubMed2003

A phase II study to determine the efficacy and tolerability of intravenous ZD9331 in heavily pretreated patients with ovarian cancer.

OBJECTIVES: This Phase II, multicenter, open-label study was conducted to assess the efficacy and tolerability of ZD9331, a novel direct-acting thymidylate synthase inhibitor, in heavily pretreated patients with ovarian cancer. METHODS: The study recruited 44 women with ovarian cancer or primary peritoneal cancer previously treated with platinum therapy and paclitaxel and with progressive disease after, or intolerance to, topotecan administered as the most recent therapy. ZD9331 was administered as an intravenous infusion at 130 mg/m(2) on Days 1 and 8 of 3-week cycles, until objective evidence of disease progression. A cutoff date of 3 months after the last patient received the first dose was set for data collection. RESULTS: Patients received a mean of 3.3 cycles of ZD9331 and a total of 143 cycles were administered. Among the 42 patients evaluated for best overall tumor response, one achieved a complete response and two achieved a partial response, giving an objective tumor response rate of 7%. The complete response occurred at Day 15 of Cycle 2 in a patient receiving ZD9331 as her eighth-line therapy. Seven patients had stable disease, giving a disease control rate of 23%. Thirty-one patients (71%) had disease progression and the median time to progression was 53 days. Most patients (89%) experienced drug-related adverse events, most commonly nausea (73%), vomiting (48%), and neutropenia (50%). Six patients (14%) were withdrawn from treatment due to adverse events. CONCLUSIONS: The preliminary evidence of efficacy and acceptable tolerability of ZD9331 in this heavily pretreated population with ovarian cancer warrants further investigation, especially in a less heavily pretreated patient population.

Adult↗