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  • 1
    In: Archives of Ophthalmology, May, 2001, Vol.119(5), p.667
    Description: Objective: To assess, the course of change of visual function outcome variables in 5 patients with gyrate atrophy before a gene replacement therapy clinical trial. Methods: The outcome variables selected were visual field sensitivity and electroretinogram amplitude. The course of change of these outcome variables was determined by calculation of their half-lives. Results: In the 4 to 6 years during which each patient was followed up for this study, median visual field half-lives were 17.0 years (static perimetry) and 11.4 years (kinetic perimetry). Median electroretinogram half-lives were 16.0 years (maximal response) and 10.7 years (flicker response). Conclusions: The course of the decline of visual function outcome variables is frequently slow. Thus, a long-term clinical trial would be required to assess the efficacy of the intervention in the preservation of visual function. Arch Ophthalmol. 2001;119:667-669
    Keywords: Retinal Diseases -- Care And Treatment ; Gene Therapy -- Usage
    ISSN: 0003-9950
    E-ISSN: 15383601
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  • 2
    Language: English
    In: Gastroenterology, November 1989, Vol.97(5), pp.1147-1158
    Description: We investigated the mechanism by which exposure to cold sensitizes rats to the formation of gastric lesions after a low dose of aspirin (50 mg/kg). Six times more lesions were produced by aspirin plus cold than by aspirin alone. Three hypotheses were studied to explain the synergism of aspirin plus cold on lesion formation: gastric acid hypersecretion, reduced gastric mucosal blood flow, and decreased prostanoid synthesis by the stomach. Cold, and cold plus aspirin, stimulated gastric acid secretion (to a similar extent), whereas aspirin had no effect. Gastric mucosal blood flow, measured by the hydrogen gas clearance method, was decreased by cold, aspirin, and aspirin plus cold, and the extent of decrease was similar. Prostanoid generation [prostaglandin E (PGE ), PGF , 6-keto PGF , and thromboxane B ]by the gastric corpus mucosa was not affected by cold, but was reduced equally (by at least 90%) in animals receiving aspirin alone or aspirin plus cold. After oral administration of aspirin, the plasma contained mostly salicylic acid (98%), whereas the gastric mucosa contained mostly aspirin (80%–85%). We conclude that the synergism of aspirin plus cold on the formation of gastric lesions probably results from the combined effects of three factors: increased secretion of acid (because of exposure to cold) that is in contact with a gastric mucosa in which blood flow is reduced (because of exposure to cold or to aspirin), and in which the synthesis of cytoprotective prostaglandins is inhibited (by aspirin). Such mucosa may be particularly vulnerable to the damaging effect of hyperacidity.
    Keywords: Medicine
    ISSN: 0016-5085
    E-ISSN: 1528-0012
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  • 3
    Language: English
    In: The American Journal of Medicine, 1986, Vol.80(3), pp.10-15
    Description: Both radiolabeled and nonlabeled drug have been used to study the pharmacokinetics of flurbiprofen (Ansaid, Upjohn). Drug absorption is rapid, drug disappearance half-life is independent of oral dose, and the area under the plasma drug concentration versus time curve increases with increasing oral dose. Elimination of intact drug from the peripheral circulation is biphasic and rapid. Following a single oral dose of 100 mg of flurbiprofen, drug bioavailability is equivalent using regimens of four 25-mg tablets, two 50-mg tablets, or one 100-mg tablet once daily. Long-term administration of flurbiprofen appears neither to inhibit nor induce the drug's metabolism.
    Keywords: Medicine
    ISSN: 0002-9343
    E-ISSN: 1555-7162
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  • 4
    In: The New England Journal of Medicine, 2006, Vol.355(14), pp.1432-1444
    Description: Background We compared ranibizumab — a recombinant, humanized, monoclonal antibody Fab that neutralizes all active forms of vascular endothelial growth factor A — with photodynamic therapy with verteporfin in the treatment of predominantly classic neovascular age-related macular degeneration. Methods During the first year of this 2-year, multicenter, double-blind study, we randomly assigned patients in a 1:1:1 ratio to receive monthly intravitreal injections of ranibizumab (0.3 mg or 0.5 mg) plus sham verteporfin therapy or monthly sham injections plus active verteporfin therapy. The primary end point was the proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months. Results Of the 423 patients enrolled, 94.3% of those given 0.3 mg of ranibizumab and 96.4% of those given 0.5 mg lost fewer than 15 letters, as compared with 64.3% of those in the verteporfin group (P〈0.001 for each comparison). Visual acuity improved by 15 letters or more in 35.7% of the 0.3-mg group and 40.3% of the 0.5-mg group, as compared with 5.6% of the verteporfin group (P〈0.001 for each comparison). Mean visual acuity increased by 8.5 letters in the 0.3-mg group and 11.3 letters in the 0.5-mg group, as compared with a decrease of 9.5 letters in the verteporfin group (P〈0.001 for each comparison). Among 140 patients treated with 0.5 mg of ranibizumab, presumed endophthalmitis occurred in 2 patients (1.4%) and serious uveitis in 1 (0.7%). Conclusions Ranibizumab was superior to verteporfin as intravitreal treatment of predominantly classic neovascular age-related macular degeneration, with low rates of serious ocular adverse events. Treatment improved visual acuity on average at 1 year. (ClinicalTrials.gov number, NCT00061594 .) Previous studies have implicated intravitreal vascular endothelial growth factor A (VEGF-A) as a target for countering neovascularization and, therefore, age-related macular degeneration. This double-blind, controlled trial comparing ranibizumab, which neutralizes all isoforms of VEGF-A, with photodynamic therapy with verteporfin showed that ranibizumab was better able to retard the progression of predominantly classic neovascular age-related macular degeneration. This trial comparing ranibizumab with photodynamic therapy with verteporfin showed that ranibizumab was better able to retard the progression of predominantly classic neovascular age-related macular degeneration. Age-related macular degeneration is a leading cause of severe and irreversible vision loss in the developed world among people 50 years of age or older.1–4 The neovascular form of the disease is characterized by the growth of abnormal, choroidal blood vessels beneath the macula, which causes severe loss of vision.5 Two main patterns of choroidal neovascularization that are associated with age-related macular degeneration, as seen on fluorescein angiography, are classic (in which intensely bright fluorescence is seen in early phases of the angiogram and leaks in late phases) and occult (in which leakage is less intense and appears in . . .
    Keywords: Medicine;
    ISSN: 0028-4793
    E-ISSN: 1533-4406
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  • 5
    In: Archives of Pediatrics & Adolescent Medicine, Dec, 1999, Vol.153(12), p.1248
    Description: Objectives: (1) To describe the pattern of injury in preschool-aged children in 4 child care centers as compared with the results of other studies; (2) to compare injury rates by sex, age, and child care center; and (3) to examine environmental and child factors contributing to injury severity. Design: A 2-year cohort study of 362 preschool-aged children attending 4 urban child care centers. Teachers completed standardized injury forms on the type of injury, body location, site of injury, and contributing factors. Results: During the 2 years of the study, 1886 injuries were reported. The mean and median child injury rate was 6 and 4 injuries per 2000 exposure hours (equivalent to 1 full-time child care year), respectively. The majority of injuries (87%) were minor, occurred during free play (81%) and on the playground (74%), and were precipitated by child-related factors (59%), such as being pushed. Boys had significantly higher median injury rates than girls. Age-adjusted injury rates for each child care center were significantly different by center ([F.sub.3] = 61, P [is less than] .001). While moderate to severe injuries were more often precipitated by combinations of child and environmental factors ([[chi square].sub.4] = 20, P [is less than] .001), minor injuries were usually precipitated by child-related factors. Conclusions: Injury data from child care centers are important for identifying common risk factors for frequent or severe injury events and for designing injury prevention programs. More research is needed to identify factors contributing to injuries, such as children's behavior and the child care centers' physical and socioemotional environments. Arch Pediatr Adolesc Med. 1999; 153:1248-1254
    Keywords: Pediatric Injuries -- Injuries ; Day Care Centers -- Health Aspects
    ISSN: 1072-4710
    E-ISSN: 15383628
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  • 6
    Language: English
    In: The Journal of Thoracic and Cardiovascular Surgery, 2010, Vol.140(3), pp.564-572
    Description: Under the Freedom of Information Act, we obtained the follow-up data of the National Emphysema Treatment Trial (NETT) to determine the long-term outcome for “a heterogeneous distribution of emphysema with upper lobe predominance,” postulated by the NETT hypothesis to be optimal candidates for lung volume reduction surgery. Using the NETT database, we identified patients with heterogeneous distribution of emphysema with upper lobe predominance and analyzed for the first time follow-up data for those receiving lung volume reduction surgery and those receiving medical management. Furthermore, we compared the results of the NETT reduction surgery group with a previously reported consecutive case series of 250 patients undergoing bilateral lung volume reduction surgery using similar selection criteria. Of the 1218 patients enrolled, 511 (42%) conformed to the NETT hypothesis selection criteria and received the randomly assigned surgical or medical treatment (surgical = 261; medical = 250). Lung volume reduction surgery resulted in a 5-year survival benefit (70% vs 60%; = .02). Results at 3 years compared with baseline data favored surgical reduction in terms of residual volume reduction (25% vs 2%;  〈 .001), University of California San Diego dyspnea score (16 vs 0 points;  〈 .001), and improved St George Respiratory Questionnaire quality of life score (12 points vs 0 points;  〈 .001). For the 513 patients with a homogeneous pattern of emphysema randomized to surgical or medical treatment, lung volume reduction surgery produced no survival advantage and very limited functional benefit. Patients most likely to benefit from lung volume reduction surgery have heterogeneously distributed emphysema involving the upper lung zones predominantly. Such patients in the NETT trial had results nearly identical to those previously reported in a nonrandomized series of similar patients undergoing lung volume reduction surgery.
    Keywords: 11.5 ; Fev 1 ; Lvrs ; Nett ; Rv;
    ISSN: 0022-5223
    E-ISSN: 1097-685X
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  • 7
    In: Clinical Pharmacology & Therapeutics, September 1966, Vol.7(5), pp.610-619
    Description: The influence of dosage form on serum levels of indoxole (2,3‐bis‐[p‐methoxyphenyll]‐indole), an anti‐inflammatory agent with low water solubility, was studied. Serum concentrations (fluorometric assay) were observed for 16 hours after the last dose in a short‐term multiple‐dose tolerance study when the compound was administered orally at four dose levels in Lipomul‐Oral emulsion. A good dose response was obtained when the average serum concentrations of individual subjects in the last dosage interval were plotted against the milligram per kilogram dose. Serum concentrations were also measured after oral administration at two dose levels in four different dosage forms. The order of serum level response was: Lipomul‐Oral emulsion ≃ soft elastic capsule 〉 aqueous suspension 〉 powder in a capsule. Potency estimates were 1.00: 1.10: 0.47: 0.16 following the first dose and 1.00: 0.72: 0.27: 0.16 following the sixth dose for the emulsion, soft elastic capsule, aqueous suspension, and powder in a capsule, respectively. Additional information is reported and discussed. The advantage of defining the serum level of a drug after the first dose and during a dosage interval at the equilibrium state is pointed out. The attempt to measure peaks and nadirs of drug concentration in the blood in multiple dose studies is less desirable than the method described above.
    Keywords: Adult–Administration & Dosage ; Anti-Inflammatory Agents–Blood ; Dosage Forms–Administration & Dosage ; Drug Tolerance–Blood ; Fluorometry–Blood ; Humans–Blood ; Indoles–Blood ; Male–Blood ; Abridged ; Anti-Inflammatory Agents ; Dosage Forms ; Indoles;
    ISSN: 0009-9236
    E-ISSN: 1532-6535
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  • 8
    Language: English
    In: The American journal of clinical nutrition, August 2014, Vol.100(2), pp.567-76
    Description: A common dietary recommendation for weight loss, especially in lay public outlets, is to eat more fruit and vegetables (F/Vs). Without a compensatory reduction in total energy intake, significant weight loss would be unlikely. We aimed to synthesize the best available evidence on the effectiveness of the general recommendation to eat more F/Vs for weight loss or the prevention of weight gain. We searched multiple databases for human randomized controlled trials that evaluated the effect of increased F/V intake on body weight. Inclusion criteria were as follows: ≥15 subjects/ treatment arm, ≥8-wk intervention, a stated primary or secondary outcome of body weight, the stated goal of the intervention was weight or fat loss or the prevention of weight or fat gain, and food intake provided or prescribed was of a variety of F/Vs that remained minimally processed. Two studies met all criteria; 5 other studies met all criteria but one. The primary analysis indicated an effect size of weight change (outcome of interest) from baseline [standardized mean difference (SMD) for studies that met all criteria] of -0.16 (95% CI: -0.78, 0.46) (P = 0.60). The SMD for 7 studies that met all or most criteria was 0.04 (95% CI: -0.10, 0.17) (P = 0.62). Studies to date do not support the proposition that recommendations to increase F/V intake or the home delivery or provision of F/Vs will cause weight loss. On the basis of the current evidence, recommending increased F/V consumption to treat or prevent obesity without explicitly combining this approach with efforts to reduce intake of other energy sources is unwarranted. This systematic review and meta-analysis was registered at http://www.crd.york.ac.uk/PROSPERO/ as CRD42013004688.
    Keywords: Diet, Reducing ; Evidence-Based Medicine ; Fruit ; Vegetables ; Overweight -- Diet Therapy
    ISSN: 00029165
    E-ISSN: 1938-3207
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  • 9
    Language: English
    In: The American journal of psychiatry, 01 April 2017, Vol.174(4), pp.378-386
    Description: Major depressive disorder is characterized by reduced reward-related striatal activation and dysfunctional reward learning, putatively reflecting decreased dopaminergic signaling. The goal of this study was to test whether a pharmacological challenge designed to facilitate dopaminergic transmission can enhance striatal responses to reward and improve reward learning in depressed individuals. In a double-blind placebo-controlled design, 46 unmedicated depressed participants and 43 healthy control participants were randomly assigned to receive either placebo or a single low dose (50 mg) of the D/D receptor antagonist amisulpride, which is believed to increase dopamine signaling through presynaptic autoreceptor blockade. To investigate the effects of increased dopaminergic transmission on reward-related striatal function and behavior, a monetary incentive delay task (in conjunction with functional MRI) and a probabilistic reward learning task were administered at absorption peaks of amisulpride. Depressed participants selected previously rewarded stimuli less frequently than did control participants, indicating reduced reward learning, but this effect was not modulated by amisulpride. Relative to depressed participants receiving placebo (and control participants receiving amisulpride), depressed participants receiving amisulpride exhibited increased striatal activation and potentiated corticostriatal functional connectivity between the nucleus accumbens and the midcingulate cortex in response to monetary rewards. Stronger corticostriatal connectivity in response to rewards predicted better reward learning among depressed individuals receiving amisulpride as well as among control participants receiving placebo. Acute enhancement of dopaminergic transmission potentiated reward-related striatal activation and corticostriatal functional connectivity in depressed individuals but had no behavioral effects. Taken together, the results suggest that targeted pharmacological treatments may normalize neural correlates of reward processing in depression; despite such acute effects on neural function, behavioral modification may require more chronic exposure. This is consistent with previous reports that antidepressant effects of amisulpride in depression emerged after sustained administration.
    Keywords: Antidepressants ; Biological Markers ; Brain Imaging Techniques ; Dopamine ; Mood Disorders-Unipolar ; Reward ; Magnetic Resonance Imaging ; Reward ; Corpus Striatum -- Drug Effects ; Depressive Disorder, Major -- Drug Therapy ; Dopamine -- Physiology ; Dopamine Antagonists -- Therapeutic Use ; Dopaminergic Neurons -- Drug Effects ; Sulpiride -- Analogs & Derivatives ; Synaptic Transmission -- Drug Effects
    ISSN: 0002953X
    E-ISSN: 1535-7228
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  • 10
    Language: English
    In: American Journal of Ophthalmology, December 1996, Vol.122(6), pp.903-905
    Description: To compare the prevalence of thyroid disease in patients with retinitis pigmentosa, in patients with gyrate atrophy of the choroid and retina, and in patients with no history of ocular disease. Forty-four patients with retinitis pigmentosa, 34 patients with gyrate atrophy, and 30 normal control patients with no ocular disease were evaluated in a case-control study for the presence of thyroid disease. Thyroid disease was diagnosed in six of 44 patients with retinitis pigmentosa and seven of 34 patients with gyrate atrophy but in only one of 30 control patients. Compared with control patients, the odds ratio for the occurrence of thyroid disease was 6.2 for patients with retinitis pigmentosa and 12.7 for patients with gyrate atrophy. These data suggest an increased occurrence of thyroid disease in patients with retinitis pigmentosa and gyrate atrophy.
    Keywords: Medicine
    ISSN: 0002-9394
    E-ISSN: 1879-1891
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