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12,231,525 |
A Phase I study of CHS 828 in patients with solid tumor malignancy.
|
Hovstadius Peter P, Larsson Rolf R, Jonsson Elin E, Skov Torsten T, Kissmeyer Anne-Marie AM, Krasilnikoff Klaus K, Bergh Jonas J, Karlsson Mats O MO, Lönnebo Anna A, Ahlgren Johan J
|
Clinical cancer research : an official journal of the American Association for Cancer Research . Vol. 8, No. 9, 2002 Sep
|
CHS 828 is a cyanoguanidine, which has demonstrated potent antitumor activity in preclinical tumor models. The activity of CHS 828 in vitro showed only low to moderate correlation to other antineoplastic agents suggesting a unique mechanism of action. Ten females and 6 males (median age 58 years) with solid tumors refractory to standard therapy were included in this Phase I study. The study drug was administered to fasting patients as a single oral dose on days 1-5 of each treatment cycle. Patients received one to six cycles of treatment. The doses ranged from 30 mg to 200 mg (total dose within a cycle). Hematological toxicity was generally mild and dominated by transient thrombocytopenia and lymphocytopenia. Nonhematological toxicity most frequently consisted of nausea, vomiting, diarrhea, fatigue, and localized genital mucositis. The dose-limiting toxicities were thrombocytopenia, thrombosis, esophagitis, diarrhea, and constipation. The recommended Phase II dose of CHS 828 was 20 mg once daily for 5 days in cycles of 28 days duration. The extent of systemic exposure of CHS 828 across patients was approximately dose proportional. The time at which the highest drug concentration occurs was 2.2 +/- 1.3 h and half-life was 2.1 +/- 0.52 h (mean +/- SD). Large intra- and interindividual variation in dose level-adjusted maximum plasma concentration and the area under the curve from time 0 h to infinity were observed. There was an apparent inverse relationship between systemic exposure of CHS 828, and thrombocyte and lymphocyte nadir levels. No objective tumor responses were observed, and 7 patients showed stable disease after two courses of therapy.
|
https://pubmed.ncbi.nlm.nih.gov/12231525/
|
[
"Clinical Trial",
"Clinical Trial, Phase I",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12231525
|
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12,231,524 |
Phase II clinical trial of N-(4-Hydroxyphenyl)retinamide and tamoxifen administration before definitive surgery for breast neoplasia.
|
Singletary S Eva SE, Atkinson Edward N EN, Hoque Ashraful A, Sneige Nour N, Sahin Ayse A AA, Fritsche Herbert A HA, Lotan Reuben R, Lu Tao T, Hittelman Walter N WN, Bevers Therese B TB, Stelling Carol B CB, Lippman Scott M SM
|
Clinical cancer research : an official journal of the American Association for Cancer Research . Vol. 8, No. 9, 2002 Sep
|
PURPOSE: Surrogate end point biomarkers (SEBs) that can be measured in ductal carcinoma in situ or early-stage invasive cancer are needed to improve the efficiency and reduce the cost of chemoprevention trials. EXPERIMENTAL DESIGN: We conducted a prospective study to develop SEBs for tamoxifen and N-[4-hydroxyphenyl]retinamide by administering either a placebo or both drugs for 2-4 weeks to women with ductal carcinoma in situ or early invasive cancers in the interval between the initial diagnostic core biopsy and definitive surgery. The major statistical end point of the study was pre- versus posttreatment change in cell proliferation, as measured by changes in Ki67 labeling indices. In addition, estrogen receptor (ER), HER2/neu, p53, retinoid receptors, and DNA index were measured. RESULTS: Between February 1997 and April 200, 52 patients were registered on the study, and 36 (20 in the placebo arm and 16 in the treatment arm) were available for analysis. No statistically significant pre- versus posttreatment differences in Ki67 labeling index or in the other markers were observed in the treatment arm compared with the placebo arm. There was a trend toward increased treatment response in ER-positive versus ER-negative patients, but this could not be rigorously analyzed because of the low sample size and the unequal distribution of ER-positive patients in the two study arms. CONCLUSION: Future SEB trials for breast carcinoma must (a) incorporate information about patient hormonal status into the study design and (b) resolve problems in patient accrual.
|
https://pubmed.ncbi.nlm.nih.gov/12231524/
|
[
"Clinical Trial",
"Clinical Trial, Phase II",
"Comparative Study",
"Controlled Clinical Trial",
"Journal Article",
"Research Support, U.S. Gov't, P.H.S."
] |
12231524
|
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] |
12,231,566 |
Effects of continuous combined hormone replacement therapy on inflammation in hypertensive and/or overweight postmenopausal women.
|
Koh Kwang Kon KK, Ahn Jeong Yeal JY, Jin Dong Kyu DK, Yoon Byung-Koo BK, Kim Hyung Sik HS, Kim Dae Sung DS, Shin Mi-Seung MS, Son Ji Won JW, Choi In Suck IS, Shin Eak Kyun EK
|
Arteriosclerosis, thrombosis, and vascular biology . Vol. 22, No. 9, 2002 Sep 01
|
OBJECTIVE: We observed that estrogen did not show cardioprotective benefits in type 2 diabetic postmenopausal women. We hypothesized that hypertensive and/or overweight women may be less likely to realize cardiovascular benefits from estrogen. METHODS AND RESULTS: We administered micronized progesterone (MP) 100 mg or medroxyprogesterone acetate (MPA) 2.5 mg with conjugated equine estrogen (CEE) 0.625 mg daily during 2 months to 35 hypertensive and/or overweight postmenopausal women with a randomized, double-blind, crossover design. With significant changes of lipoproteins, CEE+MP or MPA significantly improved flow-mediated dilation and reduced plasma E-selectin, intercellular adhesion molecule type-1, monocyte chemoattractant protein-1, and tumor necrosis factor-alpha levels (P<0.001, P<0.001, P=0.021, P<0.001, and P<0.001 by ANOVA, respectively), but not C-reactive protein and fibrinogen levels. Of note, there were no significant differences between each therapy regarding these effects. However, the magnitude of improvement of flow-mediated dilation in these women was less than in healthy postmenopausal women and more than in diabetic postmenopausal women reported by our previous studies. The effects of CEE+MP or MPA on inflammatory markers were comparable to healthy postmenopausal women, but not comparable to diabetic postmenopausal women. CONCLUSIONS: Estrogen combined with synthetic progestin significantly improved flow-mediated brachial artery dilator response and reduced inflammation markers in hypertensive and/or overweight women, comparable to estrogen combined with natural progesterone.
|
https://pubmed.ncbi.nlm.nih.gov/12231566/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12231566
|
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] |
12,231,573 |
Analysis of coagulation cascade and endothelial cell activation during inhibition of vascular endothelial growth factor/vascular endothelial growth factor receptor pathway in cancer patients.
|
Kuenen B C BC, Levi M M, Meijers J C M JC, Kakkar A K AK, van Hinsbergh V W M VW, Kostense P J PJ, Pinedo H M HM, Hoekman K K
|
Arteriosclerosis, thrombosis, and vascular biology . Vol. 22, No. 9, 2002 Sep 01
|
OBJECTIVE: The angiogenesis inhibitor SU5416 is a potent inhibitor of vascular endothelial growth factor (VEGF) receptor-1 and -2. VEGF may be involved in hemostasis by altering the hemostatic properties of endothelial cells. We analyzed the effects of SU5416 on the coagulation cascade and the vessel wall in patients with advanced cancer. METHODS AND RESULTS: Markers for thrombin generation, activation of the protein C pathway, fibrinolysis, and endothelial cell activation were measured in patients with renal cell carcinoma, soft tissue sarcoma, or melanoma on days 0, 14, and 28 of treatment with SU5416. Three of 17 sampled patients developed a thromboembolic event in the fifth week of treatment. Markers for thrombin generation and fibrinolysis did not show significant changes. We observed a significant increase in endogenous thrombin potential and of parameters reflecting endothelial cell activation (von Willebrand antigen, soluble tissue factor, and soluble E-selectin) in all patients (P< or =0.001). In patients experiencing a thromboembolic event, endogenous thrombin potential, soluble tissue factor, and soluble E-selectin increased to a significantly greater extent (P=0.029, P=0.021, and P=0.007, respectively). CONCLUSIONS: VEGF is not only a permeability, proliferation, and migration factor, but it is also a maintenance and protection factor for endothelial cells.
|
https://pubmed.ncbi.nlm.nih.gov/12231573/
|
[
"Clinical Trial",
"Clinical Trial, Phase III",
"Journal Article",
"Multicenter Study",
"Research Support, Non-U.S. Gov't"
] |
12231573
|
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] |
12,231,575 |
Comparative effects of diet and statin on NO bioactivity and matrix metalloproteinases in hypercholesterolemic patients with coronary artery disease.
|
Koh Kwang Kon KK, Son Ji Won JW, Ahn Jeong Yeal JY, Jin Dong Kyu DK, Kim Hyung Sik HS, Choi Yu Mi YM, Kim Dae Sung DS, Jeong Euy-Myoung EM, Park Gi Soo GS, Choi In Suck IS, Shin Eak Kyun EK
|
Arteriosclerosis, thrombosis, and vascular biology . Vol. 22, No. 9, 2002 Sep 01
|
OBJECTIVE: We investigated the effects of statin compared with the American Heart Association (AHA) Step I Diet on lipoproteins, vasomotor function, tumor necrosis factor (TNF)-alpha, and serological markers of plaque stability. Furthermore, we investigated the mechanism of regulation suggested by experimental studies. METHODS AND RESULTS: For 14 weeks, we administered AHA diet+placebo and AHA diet+simvastatin (20 mg daily) to 31 and 32 randomly selected patients with coronary artery disease, respectively. Compared with diet alone, simvastatin significantly improved the percent flow-mediated dilator response to hyperemia from 3.37+/-2.28% to 5.89+/-2.35% (P<0.001) and lowered plasma levels of C-reactive protein from 0.48 to 0.10 mg/dL (P<0.001), TNF-alpha from 3.38 to 2.79 pg/mL (P<0.001), total matrix metalloproteinase (MMP)-9 from 36 to 28 ng/mL (P=0.006), and tissue inhibitor of matrix metalloproteinase-1 from 80+/-30 to 74+/-23 ng/mL (P=0.041), and simvastatin lowered to a greater extent MMP-9 activity (from 71 to 52 ng/mL, P=0.006) and MMP-9 activity/tissue inhibitor of matrix metalloproteinase-1 ratios (P=0.018), although this difference did not reach statistical significance. There were significant correlations between the degree of changes in TNF-alpha and the degree of changes in MMP-9 activity (r=0.424, P=0.016). However, no significant correlations between lipoprotein levels or flow-mediated dilation percentages and levels of plaque stability markers were determined (-0.208< or =r< or =0.243). CONCLUSIONS: Simvastatin reduced serological markers of inflammation and plaque stability, independent of lipoprotein changes.
|
https://pubmed.ncbi.nlm.nih.gov/12231575/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial"
] |
12231575
|
[
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12,231,591 |
Management and outcome of patients with atrial fibrillation during acute myocardial infarction: the GUSTO-III experience. Global use of strategies to open occluded coronary arteries.
|
Wong C-K CK, White H D HD, Wilcox R G RG, Criger D A DA, Califf R M RM, Topol E J EJ, Ohman E M EM,
|
Heart (British Cardiac Society) . Vol. 88, No. 4, 2002 Oct
|
OBJECTIVE: To investigate the use of antiarrhythmic agents and electrical cardioversion in the management of patients with atrial fibrillation complicating acute myocardial infarction, and their relation to 30 day and one year mortality. DESIGN: Prospective study of 1138 patients with atrial fibrillation from the GUSTO-III trial. INTERVENTIONS: Of the 1138 study patients, 317 (28%) received antiarrhythmic treatment, including class I antiarrhythmic agents (12%), sotalol (5%), and amiodarone (15%); electrical cardioversion was attempted in 116 (10%). RESULTS: Sinus rhythm was restored in 72% of patients receiving class I antiarrhythmic agents, 67% of those receiving sotalol, 79% of those receiving amiodarone, and 64% of those having electrical cardioversion. After adjusting for baseline characteristics and complications occurring before the onset of atrial fibrillation, there was no difference among the treatment groups in the incidence of sinus rhythm at the time of discharge or before deterioration to hospital death. However, the use of class I antiarrhythmic drugs or sotalol was associated with a lower unadjusted 30 day and one year mortality. After adjustment for baseline factors and pre-atrial fibrillation complications, the odds ratios for 30 day and one year mortality were 0.42 (95% confidence interval (CI) 0.19 to 0.89) and 0.58 (95% CI 0.33 to 1.04) with class I agents, and 0.31 (95% CI 0.07 to 1.32) and 0.31 (95% CI 0.09 to 1.02) with sotalol. In contrast, there was no association between the use of amiodarone or electrical cardioversion and 30 day or one year mortality. CONCLUSIONS: There was a strong trend towards lower mortality associated with the use of class I antiarrhythmic agents or sotalol in managing patients with atrial fibrillation after acute myocardial infarction. Randomised trials are indicated.
|
https://pubmed.ncbi.nlm.nih.gov/12231591/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12231591
|
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] |
12,231,595 |
Perindopril improves six minute walking distance in older patients with left ventricular systolic dysfunction: a randomised double blind placebo controlled trial.
|
Hutcheon S D SD, Gillespie N D ND, Crombie I K IK, Struthers A D AD, McMurdo M E T ME
|
Heart (British Cardiac Society) . Vol. 88, No. 4, 2002 Oct
|
OBJECTIVE: To evaluate the effects of the angiotensin converting enzyme inhibitor perindopril on six minute walking distance and quality of life in very old patients with left ventricular systolic dysfunction. DESIGN: Prospective, double blind placebo controlled trial. SETTING: Medicine for the elderly day hospital. PATIENTS: 66 patients (average age 81) with left ventricular systolic dysfunction identified by echocardiography. INTERVENTIONS: 10 weeks of treatment with titrated doses of perindopril or placebo. MAIN OUTCOME MEASURES: Six minute walking distance 10 weeks following treatment, quality of life measurements including the Minnesota living with heart failure questionnaire and the 36 item short form health survey. RESULTS: In patients with left ventricular systolic dysfunction, six minute walking distance was significantly increased in the treatment group (37.1 m) compared with the placebo group (-0.3 m, p < 0.001). The medication was well tolerated and there were no significant adverse events. CONCLUSIONS: Six minute walking distance is improved considerably by treatment with perindopril in older patients with heart failure caused by left ventricular systolic dysfunction.
|
https://pubmed.ncbi.nlm.nih.gov/12231595/
|
[
"Clinical Trial",
"Journal Article",
"Multicenter Study",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12231595
|
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] |
12,231,656 |
Influence of different cuff inflation protocols on capillary filtration capacity in human calves -- a congestion plethysmography study.
|
Bauer A A, Bruegger D D, Gamble J J, Christ F F
|
The Journal of physiology . Vol. 543, No. Pt 3, 2002 Sep 15
|
It has been suggested that venous congestion plethysmography (VCP) substantially underestimates microvascular permeability by activation of a veni-arteriolar constrictor mechanism, even when using small (< 25 mmHg) congestion pressure steps. We studied human lower limbs of 18 young healthy volunteers to test whether the congestion pressure step size of the VCP protocol has an influence on the values of the capillary filtration capacity (CFC) and isovolumetric venous pressure (P(vi)). Two different dual stage VCP pressure step protocols, with 3 and 10 mmHg steps, were used in randomised order and separated by a transient reduction in congestion pressure. Since lymph flow is known to increase after venous congestion, we also looked to see if changes in the estimated lymph flow (J(v)L) occur as a result of these VCP protocols. The measured CFC (median [25th; 75th percentile]) was 2.6 [2.5; 3.2] x 10(-3) ml (100 ml)(-1) min(-1) mmHg(-1) with the 3 mmHg pressure step protocol, which was not different from the value of 2.9 [2.7; 3.4] x 10(-3) ml (100 ml)(-1) min(-1) mmHg(-1) obtained with 10 mmHg pressure steps. However, when either of these step sizes was applied after a transient venous decongestion, significantly higher values of CFC, 4.0 [3.4; 4.1] x 10(-3) and 3.5 [3.1; 4.5] x 10(-3) ml (100 ml)(-1) min(-1) mmHg(-1), respectively, were obtained (P < 0.05). The assessment of P(vi) was also independent of the pressure protocol (10 mmHg: 8.0 [5.7; 13.2] mmHg and 3 mmHg: 15.7 [12.5; 18.5] mmHg), but when P(vi) was measured after the transient deflation, significantly higher values were found with both 10 and 3 mmHg steps (24.1 [20.9; 27.3] and 30.4 [28.9; 30.9] mmHg, respectively; P < 0.01). The transient pressure reduction was associated with a rise in estimated J(v)L from 0.04 [0.03; 0.05] to 0.12 [0.08; 0.18] and 0.04 [0.04; 0.05] to 0.09 [0.07; 0.10] ml (100 ml)(-1) min(-1), respectively (P < 0.01). The first stage data from these protocols shows that the value of CFC is not influenced by the size of the cumulative venous pressure steps, providing they are of 10 mmHg or less. The data also show that J(v)L can be estimated with small step VCP protocols. We hypothesise that the sudden reduction in cuff pressure after venous congestion is associated with a temporary upregulation of lymph flow. As the congestion pressure is raised again, there is a modulation of the enhanced lymph flow, such that the resulting CFC slope appears greater than that obtained in the first stage of the protocol.
|
https://pubmed.ncbi.nlm.nih.gov/12231656/
|
[
"Clinical Trial",
"Controlled Clinical Trial",
"Journal Article"
] |
12231656
|
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] |
12,232,447 |
Initiation of CPAP therapy for OSA: does prophylactic humidification during CPAP pressure titration improve initial patient acceptance and comfort?
|
Wiest G H GH, Harsch I A IA, Fuchs F S FS, Kitzbichler S S, Bogner K K, Brueckl W M WM, Hahn E G EG, Ficker J H JH
|
Respiration; international review of thoracic diseases . Vol. 69, No. 5, 2002
|
BACKGROUND: Heated humidifiers (HH) enable effective treatment of upper airway dryness during nasal continuous positive airway pressure (nCPAP) therapy for obstructive sleep apnoea (OSA), but the role of prophylactic use of HH during the initiation of nCPAP treatment has not been studied so far. OBJECTIVES: The aim of the present study was to investigate whether prophylactic HH during the initiation of CPAP would result in improved initial patient comfort and acceptance. METHODS: In 44 consecutive, previously untreated OSA patients with no history of upper airway dryness, CPAP titration with and without HH was performed on two consecutive nights in a randomised order. The patients were interviewed after each treatment night in order to establish the comfort of the treatment, and, after the second treatment, they were asked which of the two nights they considered more pleasant, and which treatment they would prefer for long-term use. RESULTS: Following CPAP titration with HH, 32 patients (73%) claimed to have had a better night's sleep than usual (i.e. without CPAP treatment) compared with 33 patients (75%) saying the same following CPAP treatment without HH. For 21 patients (47.7%) treatment with HH was more pleasant, 23 (52.3%) saw no difference or said that treatment without HH was more pleasant. Nineteen patients (43.2%) gave preference to treatment with HH for long-term use, while 25 patients (56.8%) had no preference or said they would prefer treatment without HH. CONCLUSIONS: The use of HH during the initiation phase of CPAP treatment was associated neither with an initial improvement in comfort nor with greater initial treatment acceptance.
|
https://pubmed.ncbi.nlm.nih.gov/12232447/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12232447
|
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] |
12,232,450 |
A health-related quality-of-life comparison of formoterol (Oxis) Turbuhaler plus budesonide (Pulmicort) Turbuhaler with budesonide Turbuhaler alone and noncorticosteroid treatment in asthma: a randomized clinical study in Russia.
|
Chuchalin A G AG, Svensson K K, Ståhl E E, Ovcharenko S I SI, Goriachkina L A LA, Sidorenko I V IV, Tsoi A N AN,
|
Respiration; international review of thoracic diseases . Vol. 69, No. 5, 2002
|
BACKGROUND: In Russia, current therapy for the long-term management of asthma is mainly nonsteroidal. This situation provides the opportunity to evaluate new asthma treatments in a patient cohort with little previous exposure to inhaled corticosteroids. OBJECTIVES: To compare the effect of formoterol (Oxis) Turbuhaler plus budesonide (Pulmicort) Turbuhaler with budesonide Turbuhaler alone, on the health-related quality of life (HRQL) of patients with mild to moderate asthma. METHODS: A double-blind, parallel-group, randomized, 12-week study compared formoterol Turbuhaler plus budesonide Turbuhaler and budesonide Turbuhaler alone with an open control group of the investigator's choice of noncorticosteroid therapy. Patients completed the Short Form 36 (SF-36) and the Asthma Quality of Life Questionnaire (AQLQ). RESULTS: The improvement in HRQL scores for patients treated with noncorticosteroids was significantly less (p < 0.05) than those treated with formoterol plus budesonide and budesonide alone in all domains of the SF-36 and AQLQ with one marginal exception (budesonide versus investigator's choice, SF-36, Mental Component Scale, p = 0.053). Improvements in HRQL scores of formoterol plus budesonide, compared with budesonide alone, although generally higher, were not significantly different. Formoterol plus budesonide was more effective in improving lung function and reducing both symptoms and the need for relief terbutaline inhalation. CONCLUSION: Formoterol Turbuhaler plus budesonide Turbuhaler and budesonide Turbuhaler alone significantly improved the HRQL of patients with mild to moderate asthma compared with noncorticosteroid treatment.
|
https://pubmed.ncbi.nlm.nih.gov/12232450/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12232450
|
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] |
12,232,452 |
Low-molecular-weight heparin versus unfractionated heparin in the treatment of patients with acute pulmonary thromboembolism.
|
Findik Serhat S, Erkan M Levent ML, Selçuk M Bekir MB, Albayrak Selahattin S, Atici Atilla G AG, Doru Fatma F
|
Respiration; international review of thoracic diseases . Vol. 69, No. 5, 2002
|
BACKGROUND: Low-molecular-weight heparin (LMWH) appears to be as effective as unfractionated heparin (UFH) for both treatment and prophylaxis of deep vein thrombosis (DVT), but limited data are available for its use in acute pulmonary thromboembolism (PTE). OBJECTIVE: To determine whether enoxaparin, a LMWH, was clinically as efficient and safe as UFH in patients with a diagnosis of acute PTE. MATERIAL AND METHODS: After exclusion of those with massive forms, 59 patients with acute PTE were randomly assigned to either subcutaneous enoxaparin given twice daily (1 mg/kg/dose) or adjusted dose intravenous UFH. Oral anticoagulant treatment was begun on the second day and was given for at least 6 months. We compared the treatment regimens at day 8 and day 90 with respect to a combined end point of major bleeding, recurrent venous thromboembolism (VTE), and death. RESULTS: In the first 8 days of treatment, 1 of 30 patients assigned to receive UFH (3.3%) reached one of the end points (recurrence), as compared with none of 29 patients assigned to enoxaparin. Statistically this difference was not significant (p = 0.508). By day 90, 3 patients assigned to UFH (10%) had symptomatic recurrent VTE, as compared with 1 patient assigned to enoxaparin (3.4%). There was neither major bleeding nor death in the study groups. There was an absolute difference of 6.4 percentage points between the two treatment groups, but the difference was statistically not significant (p = 0.318). CONCLUSION: Initial subcutaneous treatment with enoxaparin appeared to be as effective and safe as UFH in acute PTE.
|
https://pubmed.ncbi.nlm.nih.gov/12232452/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial"
] |
12232452
|
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] |
12,232,492 |
Chronic epicondylitis: effects of real and sham acupuncture treatment: a randomised controlled patient- and examiner-blinded long-term trial.
|
Fink M M, Wolkenstein E E, Luennemann M M, Gutenbrunner C C, Gehrke A A, Karst M M
|
Forschende Komplementarmedizin und klassische Naturheilkunde = Research in complementary and natural classical medicine . Vol. 9, No. 4, 2002 Aug
|
OBJECTIVE: The clinical long-term effectiveness of real and sham acupuncture treatment on differentiated pain measurement was evaluated in chronic lateral epicondylitis, an example of a tendomyotic disorder. METHODS: Randomised, examiner- and patient-blinded controlled clinical study. OUTCOME MEASUREMENT: pain at rest, pain on movement, pain on exertion, frequency and duration of pain. Real acupuncture (n = 23) was tested versus invasive sham acupuncture (n = 22). Ten treatments were given (2 treatments/week). Patients were examined at baseline (E1) as well as 2 weeks (E2), 2 months (E3) and 1 year (E4) after the end of treatment. In the treatment with real acupuncture, acupuncture points were selected and mechanically stimulated while in the sham group non-acupuncture points were selected. RESULTS: There was no significant difference between the groups at baseline for any outcome parameter. Two weeks, 2 months and 1 year after the end of treatment there were significant reductions in all pain variables compared to baseline. At the first follow-up, significant group differences were registered for pain on motion and pain on exertion in favour to the real acupuncture group. These differences in pain intensity between the groups were no longer significant at the 2 months and 12 months follow-ups. CONCLUSION: The results suggest that, in the treatment of chronic epicondylitis, the selection of so-called real acupuncture points gives better results than invasive sham acupuncture at early follow-up. This additional effect can be interpreted as a specific effect of real acupuncture.
|
https://pubmed.ncbi.nlm.nih.gov/12232492/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12232492
|
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] |
12,232,493 |
Effect of sulfur baths on antioxidative defense systems, peroxide concentrations and lipid levels in patients with degenerative osteoarthritis.
|
Ekmekcioglu C C, Strauss-Blasche G G, Holzer F F, Marktl W W
|
Forschende Komplementarmedizin und klassische Naturheilkunde = Research in complementary and natural classical medicine . Vol. 9, No. 4, 2002 Aug
|
BACKGROUND: Due to possible antiinflammatory effects, sulfur baths are widely used for the treatment of rheumatic diseases. Previously it was demonstrated that drinking cures with sulfur can improve the antioxidative defense system and lower the peroxide levels of patients with chronic degenerative osteoarthritis. OBJECTIVE: This study therefore sought to investigate the effect of 3-week therapy with sulfur baths on antioxidative defense systems, peroxide concentrations, and lipid levels in patients with degenerative osteoarthritis. PATIENTS AND METHODS: After randomization one group of patients (n = 19) received sulfur baths during their stay at a health resort (sulfur group), whereas the other age-matched patient group served as controls (n = 19, control group), only receiving spa therapy. Total cholesterol levels, HDL, LDL, triglycerides and the antioxidative status, glutathione peroxidase, and superoxide dismutase (SOD) activities, and peroxide concentration, as an oxidative stress parameter, were evaluated at the begin and end of therapy. RESULTS: A 17.2% decline in peroxide concentrations (p = 0.10, n.s.) and significant lower SOD activities (p < 0.001) were detected in the sulfur group at the end of the therapy. Until the end of therapy total cholesterol levels changed differentially (p = 0.007) in the sulfur group (from 229.11 +/- 34.47 mg/dl to 217.46 +/- 40.45 mg/dl) and in the control group (from 197.63 +/- 34.66 mg/dl to 207.95 +/- 33.02 mg/dl). A similar significant group difference was found for LDL (p = 0.017), with a 5.9% reduction in the sulfur group and a 6.1% increase in the control group. Triglyceride concentrations were nonsignificantly reduced in both groups after 3 weeks at the health resort (sulfur group 11.2%, control group 20.2%). HDL values only minimally changed in both groups. CONCLUSIONS: The results presented here suggest that a sulfur bath therapy could cause a reduction in oxidative stress, alterations of SOD activities, and a tendency towards improvement of lipid levels.
|
https://pubmed.ncbi.nlm.nih.gov/12232493/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12232493
|
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0.18978369235992432,
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0.12647996842861176,
0.2061259001493454,
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0.11519037187099457,
0.023725390434265137,
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0.07195869088172913,
0.3337896466255188,
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] |
12,232,564 |
Comparison of verapamil and ibutilide for the suppression of immediate recurrences of atrial fibrillation after transthoracic cardioversion.
|
Sticherling Christian C, Ozaydin Mehmet M, Tada Hiroshi H, Oral Hakan H, Pelosi Frank F, Knight Bradley P BP, Strickberger S Adam SA, Morady Fred F
|
Journal of cardiovascular pharmacology and therapeutics . Vol. 7, No. 3, 2002 Jul
|
BACKGROUND: Verapamil and ibutilide blunt the atrial fibrillation-induced shortening of atrial refractoriness that may predispose to an immediate recurrence of atrial fibrillation after cardioversion. This study compared the efficacy of verapamil and ibutilide in preventing an immediate recurrence of atrial fibrillation. METHODS AND RESULTS: Transthoracic cardioversion was performed in 223 patients with atrial fibrillation. Atrial fibrillation recurred within 10 minutes after cardioversion on two occasions in 21 patients (9.4%). Twenty of these patients were randomly assigned to receive an infusion of either 0.15 mg/kg of verapamil at a rate of 2 mg/min (11 patients), or 1 mg of ibutilide over 10 minutes (9 patients). Eight patients (73%) had another episode of immediate recurrence of atrial fibrillation after verapamil, compared to two patients (22%) after ibutilide (P<0.05). Including the results after crossover, immediate recurrence of atrial fibrillation occurred in 8 of 12 patients (67%) who received verapamil, compared to 3 of 16 patients (19%) who received ibutilide (P=0.02). Verapamil and/or ibutilide successfully prevented immediate recurrence of atrial fibrillation in 17 of 20 patients (85%). After 700 days of follow-up, there was no significant difference in the recurrence rate of atrial fibrillation between the patients in whom immediate recurrence of atrial fibrillation was prevented by verapamil and/or ibutilide and the patients who were successfully converted to sinus rhythm and did not have immediate recurrence of atrial fibrillation. CONCLUSIONS: Ibutilide is more effective than verapamil in preventing immediate recurrence of atrial fibrillation. Suppression of immediate recurrence of atrial fibrillation by ibutilide and/or verapamil may allow for long-term maintenance of sinus rhythm postcardioversion as often as in patients who do not experience immediate recurrence of atrial fibrillation.
|
https://pubmed.ncbi.nlm.nih.gov/12232564/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12232564
|
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] |
12,232,562 |
HR (Venoruton1000, Paroven, 0-[beta-hydroxyethyl]-rutosides) vs. Daflon 500 in chronic venous disease and microangiopathy: an independent prospective, controlled, randomized trial.
|
Belcaro G G, Cesarone M R MR, Bavera P P, Ricci A A, Renton S S, Leon M M, Ippolito E E, Dugall M M, Acerbi G G
|
Journal of cardiovascular pharmacology and therapeutics . Vol. 7, No. 3, 2002 Jul
|
OBJECTIVES: The aim of this study was to demonstrate whether and how HR (Venoruton(1000), Paroven, 0-[beta-hydroxyethyl]-rutosides) and Daflon (diosmin, 500 mg) were comparatively effective in improving the microcirculation in venous hypertension and microangiopathy. METHODS: A group of 90 patients with severe venous hypertension due to chronic venous insufficiency, ankle swelling, and lipodermatosclerosis were included. After informed consent, patients were randomized into a Venoruton and a Daflon (DF) group: patients in the Venoruton group received oral HR (2 g/day for 8 weeks); those in the Daflon group received three 500-mg tablets daily every 8 hours. The two groups were comparable for age and sex distribution. The mean age was 41 years (SD +/- 11) in the Venoruton group (46 patients) and 41.3 (SD +/- 12) in the DF group (44 patients). RESULTS: There were no differences in microcirculatory parameters between the Venoruton and DF treatment groups at inclusion. There was no significant change between inclusion and measurements at 8 weeks in the DF group. In comparison, a significant decrease (P < .05) in RF (resting skin flux) and RAS (rate of ankle swelling) was observed in the Venoruton group (P < .001). The decrease in capillary filtration was associated with improvement in signs and symptoms (measured by an analogue scale line) (P < .05). Symptomatic improvement was clinically and statistically significant and important only in the Venoruton group. No side effects and no drop-outs were observed. CONCLUSION: Venous microangiopathy was improved by the treatment with Venoruton. The comparison with Daflon indicates that HR is comparatively more effective both on microcirculatory parameters and on signs and symptoms.
|
https://pubmed.ncbi.nlm.nih.gov/12232562/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial"
] |
12232562
|
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0.02778179571032524,
0.09602341055870056,
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] |
12,232,749 |
Oxaliplatin, fluorouracil and leucovorin for advanced biliary system adenocarcinomas: a prospective phase II trial.
|
Nehls O O, Klump B B, Arkenau H T HT, Hass H G HG, Greschniok A A, Gregor M M, Porschen R R
|
British journal of cancer . Vol. 87, No. 7, 2002 Sep 23
|
We studied the activity of combined oxaliplatin and fluorouracil-leucovorin in 16 consecutive patients with advanced biliary tract adenocarcinomas. The disease control rate (responses and stable disease) was 56% (95% confidence interval, 29-84%) and the median overall survival time was 9.5 months (range 0.9-26.8+). Therefore, this regimen might be active in biliary adenocarcinomas with further evaluation necessary.
|
https://pubmed.ncbi.nlm.nih.gov/12232749/
|
[
"Clinical Trial",
"Clinical Trial, Phase II",
"Journal Article",
"Multicenter Study",
"Research Support, Non-U.S. Gov't"
] |
12232749
|
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12,232,748 |
The role of microvessel density on the survival of patients with lung cancer: a systematic review of the literature with meta-analysis.
|
Meert A-P AP, Paesmans M M, Martin B B, Delmotte P P, Berghmans T T, Verdebout J-M JM, Lafitte J-J JJ, Mascaux C C, Sculier J-P JP
|
British journal of cancer . Vol. 87, No. 7, 2002 Sep 23
|
In order to determine whether angiogenesis is a prognostic marker in lung cancer, we performed a systematic review of the literature to assess the prognostic value on survival of microvessel count in patients with lung cancer. Published studies were identified by an electronic search in order to aggregate survival results, after a methodological assessment using a quality scale designed by the European Lung Cancer Working Party. To be eligible, a study had to deal with microvessel count assessment in lung cancer patients on the primary site and to provide survival analysis according to microvessel count expression. Microvessel count has been assessed on surgical samples by immunohistochemistry using factor VIII in 14 studies, CD34 in 10 and CD31 in eight. Respectively 1866, 1440 and 1093 non-small cell lung cancer patients were considered. The overall median quality scores were respectively 52, 59 and 59% for studies assessing microvessel count via factor VIII, CD34 and CD31, without significant difference between studies evaluable or not for meta-analysis nor between studies with significant or non significant results. Seven 'factor VIII' studies, nine 'CD34' and seven 'CD31' provided sufficient data allowing a meta-analysis on survival and were evaluable for results aggregation. This showed that a high microvessel count in the primitive lung tumour was a statistically significant poor prognostic factor for survival in non small cell lung cancer whatever it was assessed by factor VIII (HR: 1.81; 95% CI: 1.16-2.84), CD34 (HR: 1.99; 95% CI: 1.53-2.58) or CD31 (HR: 1.80; 95% CI: 1.10-2.96). Variations in survival among the individual studies can be explained in addition to patients selection criteria by the heterogeneous methodologies used to stain and count microvessels: different antibody clones, identification of 'hotspots', Weidner or Chalkey counting method, cut-off selection. Microvessel count, reflecting the angiogenesis, appears to be a poor prognostic factor for survival in surgically treated non small cell lung cancer but standardisation of angiogenesis assessment by the microvessel count is necessary.
|
https://pubmed.ncbi.nlm.nih.gov/12232748/
|
[
"Journal Article",
"Meta-Analysis",
"Research Support, Non-U.S. Gov't",
"Systematic Review"
] |
12232748
|
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] |
12,232,750 |
Impact of non-axillary sentinel node biopsy on staging and treatment of breast cancer patients.
|
Tanis P J PJ, Nieweg O E OE, Valdés Olmos R A RA, Peterse J L JL, Rutgers E J Th EJ, Hoefnagel C A CA, Kroon B B R BB
|
British journal of cancer . Vol. 87, No. 7, 2002 Sep 23
|
The purpose of this study was to evaluate the occurrence of lymphatic drainage to non-axillary sentinel nodes and to determine the implications of this phenomenon. A total of 549 breast cancer patients underwent lymphoscintigraphy after intratumoural injection of (99m)Tc-nanocolloid. The sentinel node was intraoperatively identified with the aid of intratumoural administered patent blue dye and a gamma-ray detection probe. Histopathological examination of sentinel nodes included step-sectioning at six levels and immunohistochemical staining. A sentinel node outside level I or II of the axilla was found in 149 patients (27%): internal mammary sentinel nodes in 86 patients, other non-axillary sentinel nodes in 44 and both internal mammary and other non-axillary sentinel nodes in nineteen patients. The intra-operative identification rate was 80%. Internal mammary metastases were found in seventeen patients and metastases in other non-axillary sentinel nodes in ten patients. Staging improved in 13% of patients with non-axillary sentinel lymph nodes and their treatment strategy was changed in 17%. A small proportion of clinically node negative breast cancer patients can be staged more precisely by biopsy of sentinel nodes outside level I and II of the axilla, resulting in additional decision criteria for postoperative regional or systemic therapy.
|
https://pubmed.ncbi.nlm.nih.gov/12232750/
|
[
"Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12232750
|
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] |
12,232,752 |
Phase II study to evaluate combining gemcitabine with flutamide in advanced pancreatic cancer patients.
|
Corrie P P, Mayer A A, Shaw J J, D'Ath S S, Blagden S S, Blesing C C, Price P P, Warner N N
|
British journal of cancer . Vol. 87, No. 7, 2002 Sep 23
|
A phase II study was undertaken to determine the safety of combining flutamide with gemcitabine, with response rate being the primary end point. Twenty-seven patients with histologically proven, previously untreated, unresectable pancreatic adenocarcinoma received gemcitabine, 1 g m(-2) intravenously on days 1, 8 and 15 of a 28 day cycle, and flutamide 250 mg given orally three times daily. Treatment was halted if there was unacceptable toxicity, or evidence of disease progression. Toxicity was documented every cycle. Tumour assessment was undertaken after cycles 2 and 4, and thereafter at least every additional four cycles. One hundred and seventeen cycles of treatment were administered, median four cycles per patient (range 1-18). Gemcitabine combined with flutamide was well tolerated, with most toxicities being recorded as grade 1 or 2 and only nine treatment cycles associated with grade 3 toxicity. The most frequent toxicity was myelosuppression. One case of transient jaundice was recorded. The commonest symptomatic toxicity was nausea and vomiting. The response rate was 15% (four partial responses), median survival 6 months and 22% of patients were alive at 1 year. These results suggest antitumour activity of the combination therapy to be equivalent to single agent gemcitabine.
|
https://pubmed.ncbi.nlm.nih.gov/12232752/
|
[
"Clinical Trial",
"Clinical Trial, Phase II",
"Journal Article"
] |
12232752
|
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] |
12,232,751 |
Sentinel node detection in N0 cancer of the pharynx and larynx.
|
Werner J A JA, Dünne A-A AA, Ramaswamy A A, Folz B J BJ, Lippert B M BM, Moll R R, Behr Th T
|
British journal of cancer . Vol. 87, No. 7, 2002 Sep 23
|
Neck lymph node status is the most important factor for prognosis in head and neck squamous cell carcinoma. Sentinel node detection reliably predicts the lymph node status in melanoma and breast cancer patients. This study evaluates the predictive value of sentinel node detection in 50 patients suffering from pharyngeal and laryngeal carcinomas with a N0 neck as assessed by ultrasound imaging. Following 99m-Technetium nanocolloid injection in the perimeter of the tumour intraoperative sentinel node detection was performed during lymph node dissection. Postoperatively the histological results of the sentinel nodes were compared with the excised neck dissection specimen. Identification of sentinel nodes was successful in all 50 patients with a sensitivity of 89%. In eight cases the sentinel node showed nodal disease (pN1). In 41 patients the sentinel node was tumour negative reflecting the correct neck lymph node status (pN0). We observed one false-negative result. In this case the sentinel node was free of tumour, whereas a neighbouring lymph node contained a lymph node metastasis (pN1). Although we have shown, that skipping of nodal basins can occur, this technique still reliably identifies the sentinel nodes of patients with squamous cell carcinoma of the pharynx and larynx. Future studies must show, if sentinel node detection is suitable to limit the extent of lymph node dissection in clinically N0 necks of patients suffering from pharyngeal and laryngeal squamous cell carcinoma.
|
https://pubmed.ncbi.nlm.nih.gov/12232751/
|
[
"Clinical Trial",
"Journal Article"
] |
12232751
|
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] |
12,232,753 |
Weekly epirubicin in patients with hormone-resistant prostate cancer.
|
Petrioli R R, Fiaschi A I AI, Pozzessere D D, Messinese S S, Sabatino M M, Marsili S S, Correale P P, Manganelli A A, Salvestrini F F, Francini G G
|
British journal of cancer . Vol. 87, No. 7, 2002 Sep 23
|
The aim of this study was to investigate the benefit of weekly epirubicin in the treatment of metastatic hormone-resistant prostate cancer. One hundred and forty-eight patients with metastatic hormone-resistant prostate cancer received weekly 30-min intravenous infusions of epirubicin 30 mg m(2) of body surface area. The primary end-point was palliative response, defined as a reduction in pain intensity and an improvement in performance status. The secondary end-points were the duration of the palliative response, quality of life and survival. Fifty-seven (44%) of the 131 evaluable patients met the primary criterion of palliative response after six treatment cycles and 73 (56%) after 12 cycles; the median duration of the response was 9 months (range 1-11). The median global quality of life improved in 52% of the patients after six cycles and in 68% after 12 cycles. The 12- and 18-month survival rates were respectively 56 and 31%, with a median survival of 13+ months (range 1-36). The treatment was well tolerated: grade 3 neutropenia was observed in 8% of the patients, grade 3 anaemia in 7%, and grade 3 thrombocytopenia in 3%. None of the patients developed grade 4 toxicity or congestive heart failure. Weekly epirubicin chemotherapy can lead to a rapid and lasting palliative result in patients with metastatic HRPC, and have a positive effect on the quality of life and survival.
|
https://pubmed.ncbi.nlm.nih.gov/12232753/
|
[
"Clinical Trial",
"Clinical Trial, Phase II",
"Journal Article"
] |
12232753
|
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] |
12,232,755 |
Irinotecan in patients with relapsed or cisplatin-refractory germ cell cancer: a phase II study of the German Testicular Cancer Study Group.
|
Kollmannsberger C C, Rick O O, Klaproth H H, Kubin T T, Sayer H G HG, Hentrich M M, Welslau M M, Mayer F F, Kuczyk M M, Spott C C, Kanz L L, Bokemeyer C C
|
British journal of cancer . Vol. 87, No. 7, 2002 Sep 23
|
Despite generally high cure rates in patients with metastatic germ cell cancer, patients with progressive disease on first-line cisplatin-based chemotherapy or with relapsed disease following high-dose salvage therapy exhibit a very poor prognosis. Irinotecan has shown antitumour activity in human testicular tumour xenografts in nude mice. We have performed a phase II study examining the single agent activity of irinotecan in patients with metastatic relapsed or cisplatin-refractory germ cell cancer. Refractory disease was defined as progression or relapse within 4 weeks after cisplatin-based chemotherapy or relapse after salvage high-dose chemotherapy with autologous stem cell support. Irinotecan was administered at a dose of 300 (-350) mg m(-2) every 3 weeks. Response was evaluated every 4 weeks. Fifteen patients have been enrolled. Median age was 35 (19-53) years. Primary tumour localisation was gonadal/mediastinal in 12/3 patients. Patients had been pretreated with a median of six (4-12) cisplatin-containing cycles and 13 out of 15 patients had previously failed high-dose chemotherapy with blood stem cell support. Median number of irinotecan applications was two (1-3). Fourteen patients are assessable for response and all for toxicity. In one patient, no adequate response evaluation was performed. Toxicity was generally acceptable and consisted mainly of haematological side effects with common toxicity criteria 3 degrees anaemia (two patients), common toxicity criteria 3 degrees leukocytopenia (one patient) and common toxicity criteria 3 degrees thrombocytopenia (three patients). Common toxicity criteria 3/4 degrees non-haematological toxicity occurred in five patients (33%): 1 x diarrhoea, 2 x alopecia, 1 x fever and in one patient worsening of pre-existing peripheral polyneuropathy from 1 degrees to 4 degrees. No response was observed to irinotecan therapy. Currently, 13 patients have died of the disease and two patients are alive with the disease. The patients included in our study exhibit similar prognostic characteristics as patients treated in previous trials evaluating new drugs in this setting. Irinotecan at a dose of 300-350 mg m(-2) every 3 weeks appears to have no antitumour activity in patients with cisplatin-refractory germ cell cancer and, thus, further investigation in this disease is not justified.
|
https://pubmed.ncbi.nlm.nih.gov/12232755/
|
[
"Clinical Trial",
"Clinical Trial, Phase II",
"Journal Article"
] |
12232755
|
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] |
12,232,756 |
The imPaCT study: a randomised controlled trial to evaluate a hospital palliative care team.
|
Hanks G W GW, Robbins M M, Sharp D D, Forbes K K, Done K K, Peters T J TJ, Morgan H H, Sykes J J, Baxter K K, Corfe F F, Bidgood C C
|
British journal of cancer . Vol. 87, No. 7, 2002 Sep 23
|
A randomised controlled trial was undertaken to assess the effectiveness of a hospital Palliative Care Team (PCT) on physical symptoms and health-related quality of life (HRQoL); patient, family carer and primary care professional reported satisfaction with care; and health service resource use. The full package of advice and support provided by a multidisciplinary specialist PCT ('full-PCT') was compared with limited telephone advice ('telephone-PCT', the control group) in the setting of a teaching hospital trust in the SW of England. The trial recruited 261 out of 684 new inpatient referrals; 175 were allocated to 'full-PCT', 86 to 'telephone-PCT' (2 : 1 randomisation); with 191 (73%) being assessed at 1 week. There were highly significant improvements in symptoms, HRQoL, mood and 'emotional bother' in 'full-PCT' at 1 week, maintained over the 4-week follow-up. A smaller effect was seen in 'telephone-PCT'; there were no significant differences between the groups. Satisfaction with care in both groups was high and there was no significant difference between them. These data reflect a high standard of care of patients dying of cancer and other chronic diseases in an acute hospital environment, but do not demonstrate a difference between the two models of service delivery of specialist palliative care.
|
https://pubmed.ncbi.nlm.nih.gov/12232756/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12232756
|
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] |
12,232,835 |
Syphilis in pregnancy in Tanzania. II. The effectiveness of antenatal syphilis screening and single-dose benzathine penicillin treatment for the prevention of adverse pregnancy outcomes.
|
Watson-Jones Deborah D, Gumodoka Balthazar B, Weiss Helen H, Changalucha John J, Todd James J, Mugeye Kokungoza K, Buvé Anne A, Kanga Zephrine Z, Ndeki Leonard L, Rusizoka Mary M, Ross David D, Marealle Janeth J, Balira Rebecca R, Mabey David D, Hayes Richard R
|
The Journal of infectious diseases . Vol. 186, No. 7, 2002 Oct 01
|
Treatment for maternal syphilis with single-dose benzathine penicillin (2.4 million units intramuscularly) is being implemented in many parts of sub-Saharan Africa. To examine the effectiveness of this regimen, a prospective cohort of 1688 pregnant women was recruited in Tanzania. Birth outcomes were compared among women treated for high-titer (n=133; rapid plasma reagin [RPR] titer > or = 1:8 and Treponema pallidum hemagglutination assay [TPHA]/fluorescent treponemal antibody [FTA] positive) and low-titer (n=249; RPR titer <1:8 and TPHA/FTA positive) active syphilis and 950 uninfected women. Stillbirth or low-birth-weight live births were observed in 2.3% and 6.3%, respectively, of women treated for high-titer active syphilis and in 2.5% and 9.2%, respectively, of seronegative women. There was no increased risk for adverse pregnancy outcome for women treated for high-titer active syphilis (odds ratio [OR], 0.76; 95% confidence interval [CI], 0.4-1.4) or low-titer active syphilis (OR, 0.95; 95% CI, 0.6-1.5), compared with seronegative women. Single-dose treatment is effective in preventing adverse pregnancy outcomes attributable to maternal syphilis.
|
https://pubmed.ncbi.nlm.nih.gov/12232835/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12232835
|
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] |
12,232,843 |
Influence of filgrastim (granulocyte colony-stimulating factor) on human immunodeficiency virus type 1 RNA in patients with cytomegalovirus retinitis.
|
Davidson Michael M, Min Yuan-I YI, Holbrook Janet T JT, Van Natta Mark M, Quinn Thomas C TC, Murphy Robert L RL, Welch William W, Jabs Douglas A DA, Meinert Curtis L CL,
|
The Journal of infectious diseases . Vol. 186, No. 7, 2002 Oct 01
|
Filgrastim, or granulocyte colony-stimulating factor, reverses neutropenia associated with human immunodeficiency virus type 1 (HIV-1) and cytomegalovirus (CMV) infections. During a trial of anti-CMV retinitis therapies coadministered with antiretroviral therapy, 2-4 plasma specimens of HIV-1 RNA were collected from 36 HIV-1-infected patients receiving filgrastim to prevent neutropenia and from 36 patients not receiving filgrastim. For both groups, the crude mean and mean rate of change of HIV-1 log(10) RNA levels were similar. Adjustment for covariates (CD4(+) T cell lymphocytes, virus load at enrollment, level of neutropenia and antiretroviral therapy [mainly non-highly active antiretroviral therapy], and anti-CMV therapy during follow-up) resulted in a mean log(10) HIV-1 RNA level for individuals receiving filgrastim versus those not receiving the drug of 5.11 versus 4.87 (P=.12) and respective log mean rates of change per month of -0.08 versus -0.21 (P=.08). This latter difference has borderline statistical significance, which suggests that filgrastim may reduce the decline of HIV-1 RNA loads.
|
https://pubmed.ncbi.nlm.nih.gov/12232843/
|
[
"Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, P.H.S."
] |
12232843
|
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12,232,846 |
Once-daily quadruple-drug therapy with adefovir dipivoxil, Lamivudine, Didanosine, and efavirenz in treatment-naive human immunodeficiency virus type 1-infected patients.
|
Skowron Gail G, Kuritzkes Daniel R DR, Thompson Melanie A MA, Squires Kathleen E KE, Goodwin S Diane SD, Dusak Betsy A BA, Tolson Jerry M JM, Stevens Michael M, Yuen Geoffrey J GJ, Rooney James F JF,
|
The Journal of infectious diseases . Vol. 186, No. 7, 2002 Oct 01
|
A 48-week open-label study of 11 antiretroviral-naive, human immunodeficiency virus type 1 (HIV-1)-infected adults evaluated once-daily treatment with adefovir dipivoxil, lamivudine, didanosine, and efavirenz. At baseline, the median plasma HIV-1 RNA level was 4.99 log(10) copies/mL, and the median CD4 cell count was 471 cells/mm(3). At 24 and 48 weeks after initiation of treatment, median HIV-1 RNA levels decreased from baseline by 4.77 and 4.99 log(10) copies/mL, respectively, and median CD4 cell counts increased by 135 and 177 cells/mm(3), respectively. The regimen was generally well tolerated. No patients withdrew from the study because of adverse events. However, 7 patients developed adefovir-related nephrotoxicity after >/=20 weeks of treatment; this resolved without sequelae after adefovir was discontinued. Overall adherence was 85%. Once-daily quadruple-drug therapy with adefovir, lamivudine, didanosine, and efavirenz provides pronounced and durable suppression of HIV-1 RNA and elevation of CD4 cell counts over the course of 48 weeks, with generally good tolerability and adherence.
|
https://pubmed.ncbi.nlm.nih.gov/12232846/
|
[
"Clinical Trial",
"Clinical Trial, Phase II",
"Comparative Study",
"Journal Article"
] |
12232846
|
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-0.25573259592056274,
0.32925066351890564,
0.1394835114479065
] |
12,232,886 |
Effects of pelvic floor muscle training on strength and predictors of response in the treatment of urinary incontinence.
|
Theofrastous J P JP, Wyman J F JF, Bump R C RC, McClish D K DK, Elser D M DM, Bland D R DR, Fantl J A JA
|
Neurourology and urodynamics . Vol. 21, No. 5, 2002
|
AIMS: The objectives of this study were (1) to determine the effect of training on pelvic floor muscle strength; (2) to determine whether changes in pelvic floor muscle strength correlate with changes in continence; and (3) to determine whether demographic characteristics, clinical incontinence severity indices, or urodynamic measures predict response to pelvic floor muscle training. METHODS: One hundred thirty-four women with urinary incontinence (95=genuine stress incontinence [GSI]; 19=detrusor instability [DI]; 20=mixed incontinence [GSI+DI]) were randomized to pelvic floor muscle training (n=67) or bladder training (n=67). Urinary diaries, urodynamic evaluation, and vaginal pressure measurements by using balloon manometry were performed at baseline and after 12 weeks of therapy. Primary outcome measures consisted of incontinent episodes per week and vaginal pressure measurements. RESULTS: Both treatment groups had a reduction in incontinent episodes (P</=0.004). Vaginal pressures increased more with pelvic floor muscle training than with bladder training (P=0.0003). Other than a weak correlation between a reduction in incontinent episodes/week and an increase in maximum sustained vaginal pressure in women with GSI (r=0.32, P=0.04), there were no significant correlations between increases in pelvic floor muscle strength and improvement in continence status. There were no significant correlations between baseline demographic characteristics, clinical incontinence severity, or urodynamic measures and increases in vaginal pressure or improvement in clinical severity after pelvic floor muscle training. CONCLUSIONS: Pelvic floor muscle training improves continence and increases vaginal pressure measurements, but the direct correlations between these alterations are weak. A woman's response to behavioral treatment does not depend on her demographic characteristics, clinical incontinence severity, urodynamic measures, or initial pelvic floor muscle strength.
|
https://pubmed.ncbi.nlm.nih.gov/12232886/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, U.S. Gov't, P.H.S."
] |
12232886
|
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] |
12,232,954 |
Physical activity and coronary heart disease in older adults. A systematic review of epidemiological studies.
|
Batty G David GD
|
European journal of public health . Vol. 12, No. 3, 2002 Sep
|
BACKGROUND: While there is good evidence to suggest an inverse relation of physical activity and cardiorespiratory fitness with coronary heart disease (CHD) in middle-aged men and women, much less is known about this association in older adults. The purpose of this paper was to explore the relation of physical activity and cardiorespiratory fitness with CHD in older adults by reviewing relevant studies. METHODS: Publications were identified in two ways: i) conducting a PUBMED search from its inception in 1966 until January 2001; and ii) scrutinizing the reference sections of identified papers. RESULTS: Ten studies relating physical activity and two relating cardiorespiratory fitness in older people to CHD met the inclusion criteria. With one exception, the studies were observational in nature and the majority of these were of prospective cohort design. Most studies featured men only. Of the eleven studies that presented data on older men, eight reported an inverse relation between physical activity or cardiorespiratory fitness and CHD, and statistical significance was seen in five of these. There were too few data on older women to draw clear conclusions regarding the association in this group. CONCLUSIONS: This review suggests that, in older adult men, physical activity and cardiorespiratory fitness are inversely related to CHD risk. This association is unlikely to be attributable to reverse causality or confounding. Except where such advice is contraindicated, older adult men may benefit from physical activity in terms of reduced CHD risk.
|
https://pubmed.ncbi.nlm.nih.gov/12232954/
|
[
"Journal Article",
"Research Support, Non-U.S. Gov't",
"Review",
"Systematic Review"
] |
12232954
|
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] |
12,233,274 |
Healing of fresh tibial fractures with OP-1. A preliminary report.
|
Maniscalco Pietro P, Gambera Dario D, Bertone Celeste C, Rivera Fabrizio F, Crainz Edoardo E, Urgelli Stefano S
|
Acta bio-medica : Atenei Parmensis . Vol. 73, No. 1-2, 2002
|
Osteogenic proteins (OP) are elements of a class of natural growth factors called Bone Morphogenetic Proteins (BMP). A specific member of this class is OP-1, a human recombinant protein that has osteogenic properties. The osteoinductive and osteoconductive properties of OP-1, with its specific collagen matrix, promote the generation of new functionally active, biologically and biomechanically mature bone. We carried out a clinical study to verify the potential of this protein in fresh tibial closed fractures, using OP-1 associated with osteosynthesis by means of a monolateral external fixator.
|
https://pubmed.ncbi.nlm.nih.gov/12233274/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12233274
|
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12,233,808 |
Ginger syrup as an antiemetic in early pregnancy.
|
Keating Angela A, Chez Ronald A RA
|
Alternative therapies in health and medicine . Vol. 8, No. 5
|
CONTEXT: Ginger (Zingiber officinale) has been used to ameliorate symptoms of nausea. A beverage containing ginger in a syrup may be easier to consume than a capsule or solid food. OBJECTIVE: To determine if ginger syrup mixed in water is an effective remedy for the relief of nausea and vomiting in the first trimester of pregnancy. DESIGN: Double-blind, placebo-controlled, randomized clinical trial. SETTING: Subjects were enrolled from the University of South Florida department of obstetrics and gynecology private practice office. PATIENTS: 26 subjects in the first trimester of pregnancy. INTERVENTION: Subjects ingested 1 tablespoon of commercially prepared study syrup (or placebo) in 4 to 8 ounces of hot or cold water 4 times daily. MAIN OUTCOME MEASURES: Duration and severity of nausea and vomiting over a 2-week period measured on a 10-point scale. RESULTS: After 9 days, 10 of the 13 (77%) subjects receiving ginger had at least a 4-point improvement on the nausea scale. Only 2 of the 10 (20%) remaining subjects in the placebo group had the same improvement. Conversely, no woman in the ginger group, but 7 (70%) of the women in the placebo group, had a 2-point or less improvement on the nausea scale. Eight of the 12 (67%) women in the ginger group who were vomiting daily at the beginning of the treatment stopped vomiting by day 6. Only 2 of the 10 (20%) women in the placebo group who were vomiting stopped by day 6. CONCLUSION: The ingestion of 1 g of ginger in syrup in a divided dose daily may be useful in some patients experiencing nausea and vomiting in the first trimester of pregnancy.
|
https://pubmed.ncbi.nlm.nih.gov/12233808/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12233808
|
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12,233,807 |
Leech therapy for symptomatic treatment of knee osteoarthritis: results and implications of a pilot study.
|
Michalsen Andreas A, Moebus Susanne S, Spahn Günther G, Esch Tobias T, Langhorst Jost J, Dobos Gustav J GJ
|
Alternative therapies in health and medicine . Vol. 8, No. 5
|
CONTEXT: Leech therapy was a mainstay in conventional treatment for pain from antiquity until the mid-19th century. Its use is still widespread in traditional healing procedures in Asia, Africa, and Arabic countries. There is renewed interest in leech therapy in the field of complementary medicine and empirical evidence for specific benefit in knee osteoarthritis. OBJECTIVES: To determine the effect of leech therapy as an adjunctive treatment in painful knee osteoarthritis, to investigate the onset of action, to evaluate patients' acceptance of this treatment, and to investigate the side effects of the procedure. DESIGN: Observational, controlled, nonrandomized pilot-study. SETTING: Subjects were inpatients of an academic teaching hospital of the University of Essen, Department of Internal and Integrative Medicine, Essen, Germany. PATIENTS: 16 inpatients (mean age 69 +/- 9 years) with a confirmed diagnosis of osteoarthritis of the knee joint; 10 patients were treated with leeches and 6 served as controls. INTERVENTION: A single trial of 4 leeches (Hirudo medicinalis) applied topically at painful periarticular sites of the knee joint in the experimental group (n = 10). Both groups received conventional treatment for pain with the exclusion of nonsteroidal anti-inflammatory drugs. MAIN OUTCOME MEASURES: Self-reported general knee pain, assessed by visual analog scale for 10 days daily and in a follow-up after 28 days. Frequency of adverse effects also was recorded. RESULTS: Periarticular application of 4 leeches led to rapid relief of pain with sustained improvement after 4 weeks in the absence of major complications. CONCLUSION: Leech therapy may be an effective treatment for rapid reduction of pain associated with osteoarthritis of the knee. Its efficacy should be tested in larger randomized controlled trials with assessment of expectation bias.
|
https://pubmed.ncbi.nlm.nih.gov/12233807/
|
[
"Clinical Trial",
"Controlled Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12233807
|
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] |
12,233,868 |
Guidelines for the prevention of intravascular catheter-related infections. Centers for Disease Control and Prevention.
|
O'Grady Naomi P NP, Alexander Mary M, Dellinger E Patchen EP, Gerberding Julie L JL, Heard Stephen O SO, Maki Dennis G DG, Masur Henry H, McCormick Rita D RD, Mermel Leonard A LA, Pearson Michele L ML, Raad Issam I II, Randolph Adrienne A, Weinstein Robert A RA
|
MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports . Vol. 51, No. RR-10, 2002 Aug 09
|
These guidelines have been developed for practitioners who insert catheters and for persons responsible for surveillance and control of infections in hospital, outpatient, and home health-care settings. This report was prepared by a working group comprising members from professional organizations representing the disciplines of critical care medicine, infectious diseases, health-care infection control, surgery anesthesiology interventional radiology pulmonary medicine, pediatric medicine, and nursing. The working group was led by the Society of Critical Care Medicine (SCCM), in collaboration with the Infectious Disease Society of America (IDSA), Society for Healthcare Epidemiology ofAmerica (SHEA), Surgical Infection Society (SIS), American College of Chest Physicians (ACCP), American Thoracic Society (ATS), American Society of Critical Care Anesthesiologists (ASCCA), Association for Professionals in Infection Control and Epidemiology (APIC), Infusion Nurses Society (INS), Oncology Nursing Society (ONS), Society of Cardiovascular and Interventional Radiology (SCVIR), American Academy of Pediatrics (AAP), and the Healthcare Infection Control Practices Advisory Committee (HICPAC) of the Centers for Disease Control and Prevention (CDC) and is intended to replace the Guideline for Prevention of Intravascular Device-Related Infections published in 1996 These guidelines are intended to provide evidence-based recommendations for preventing catheter-related infections. Major areas of emphasis include 1) educating and training health-care providers who insert and maintain catheters; 2) using maximal sterile barrier precautions during central venous catheter insertion; 3) using a 2% chlorhexidine preparation for skin antisepsis; 4) avoiding routine replacement of central venous catheters as a strategy to prevent infection; and 5) using antiseptic/antibiotic impregnated short-term central venous catheters if the rate of infection is high despite adherence to other strategies (i.e., education and training, maximal sterile barrier precautions, and 2% chlorhexidine for skin antisepsis). These guidelines also identify performance indicators that can be used locally by health-care institutions or organizations to monitor their success in implementing these evidence-based recommendations.
|
https://pubmed.ncbi.nlm.nih.gov/12233868/
|
[
"Guideline",
"Journal Article",
"Practice Guideline"
] |
12233868
|
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12,233,885 |
Modified anti-CD3 therapy in psoriatic arthritis: a phase I/II clinical trial.
|
Utset Tammy O TO, Auger Julie A JA, Peace Donna D, Zivin Robert A RA, Xu Danlin D, Jolliffe Linda L, Alegre Maria-Luisa ML, Bluestone Jeffrey A JA, Clark Marcus R MR
|
The Journal of rheumatology . Vol. 29, No. 9, 2002 Sep
|
OBJECTIVE: Treatment of autoimmune diseases with therapies that tolerize pathogenic lymphocytes may obviate the need for longterm global immunosuppression. In vitro, non-Fc receptor binding derivatives of anti-murine CD3 monoclonal antibodies tolerize type 1 T cells and stimulate type 2 T cells. Recently, a humanized non-FcR binding derivative of the anti-human CD3 Mab OKT3, huOKT3gamma1(ala-ala), has been described. We hypothesized that this Mab may be safe and efficacious in the treatment of type 1 T lymphocyte mediated chronic autoimmune diseases such as psoriatic arthritis (PsA). METHODS: In a Phase I/II trial, 7 patients with PsA were treated with escalating daily doses of huOKT3gamma1(ala-ala) for 12 to 14 days. Number of tender and swollen joints and a visual analog pain scale were used to rate disease activity at entry and Day 30 and Day 90 after treatment. RESULTS: At Day 30, 6 of 7 patients had > or = 75% improvement in the number of inflamed joints and an average 63% improvement on the patient pain scale. Two of 6 responders had sustained improvement at Day 90. No patient treated with an initial dose < or = 1 mg had significant side effects, nor did they have detectable increases in serum cytokines. One patient treated with 4 mg without escalation developed mild cytokine release symptoms associated with elevation of interleukin 10. Transient T cell depletion occurred following treatment with the maximum dose of 4 mg, which resolved by Day 30. Antiidiotypic antibodies developed in 2 patients; however, there was no concurrent decrease in efficacy. CONCLUSION: These data indicate that huOKT3gamma1(ala-ala) may be useful in treating PsA.
|
https://pubmed.ncbi.nlm.nih.gov/12233885/
|
[
"Clinical Trial",
"Clinical Trial, Phase I",
"Clinical Trial, Phase II",
"Journal Article",
"Research Support, U.S. Gov't, P.H.S."
] |
12233885
|
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] |
12,233,895 |
Influence of Helicobacter pylori eradication therapy on the occurrence of gastrointestinal events in patients treated with conventional nonsteroidal antiinflammatory drugs combined with omeprazole.
|
Bannwarth Bernard B, Dorval Etienne E, Caekaert Agnes A, Barthelemy Philippe P
|
The Journal of rheumatology . Vol. 29, No. 9, 2002 Sep
|
OBJECTIVE: To evaluate the effect of eradication treatment of Helicobacter pylori and the influence of H. pylori status on the incidence of gastrointestinal (GI) events in rheumatic patients receiving longterm conventional nonsteroidal antiinflammatory drug (NSAID) therapy combined with omeprazole. METHODS: Patients (n = 919) requiring longterm NSAID therapy entered this multicenter, open label, parallel group study. H. pylori positive patients were randomized to receive either eradication therapy (omeprazole 20 mg bid, amoxicillin 1 g bid, and clarithromycin 500 mg bid for 7 days) or no therapy. Both these groups and the H. pylori negative patients were given omeprazole, 20 mg once daily, along with NSAID for the study duration (5-8 weeks). Treatment failure (primary outcome variable) was defined as the occurrence of severe GI event (symptomatic ulcer, bleeding, perforation) or dyspepsia leading to discontinuation of NSAID therapy, unscheduled consultation, or upper GI tract endoscopy. RESULTS: Treatment failure was recorded in 9/294 (3.06%) infected patients receiving eradication therapy, 8/219 (3.65%) infected patients receiving omeprazole alone, and 5/391 (1.28%) H. pylori negative patients (p > 0.05). H. pylori eradication did not appear to influence the incidence and severity of dyspeptic symptoms in infected patients. CONCLUSION: Our results do not support the use of H. pylori eradication therapy in rheumatic patients receiving conventional NSAID along with omeprazole.
|
https://pubmed.ncbi.nlm.nih.gov/12233895/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Multicenter Study",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12233895
|
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] |
12,233,894 |
14 day endoscopy study comparing risedronate and alendronate in postmenopausal women stratified by Helicobacter pylori status.
|
Thomson Alan B R AB, Marshall John K JK, Hunt Richard H RH, Provenza J Mark JM, Lanza Frank L FL, Royer Mary G MG, Li Zhengqing Z, Blank Marion A MA,
|
The Journal of rheumatology . Vol. 29, No. 9, 2002 Sep
|
OBJECTIVE: Bisphosphonates are effective treatment for osteoporosis but have been associated with gastrointestinal (GI) mucosal injury. This study compared the incidence of gastric ulcers after treatment with risedronate, a pyridinyl bisphosphonate, or alendronate, a primary amino bisphosphonate, in healthy postmenopausal women stratified by Helicobacter pylori status. METHODS: Subjects were randomized to receive risedronate 5 mg (n = 318) or alendronate 10 mg (n = 317) daily for 14 days. Endoscopy and evaluator-blind assessments of the esophageal, gastric, and duodenal mucosa were performed at baseline and on Days 8 and 15. RESULTS: Overall, gastric ulcers > or = 3 mm were observed in 18 (6.0%) of 300 evaluable subjects in the risedronate group and 36 (12.1%) of 297 in the alendronate group during treatment (p = 0.013). On Day 8, the incidences of gastric ulcers in the risedronate and alendronate groups were 3.6% and 6.6%, respectively (p = 0.133), and on Day 15, they were 3.3% and 8.7% (p = 0.008). The incidence of gastric ulcers was not affected by H. pylori status. Mean gastric endoscopy scores at Days 8 and 15 were significantly lower in the risedronate group than in the alendronate group (p < 0.001). Mean esophageal and duodenal endoscopy scores were similar in the 2 groups at Days 8 and 15. When the treatment groups were combined, gastric endoscopy scores were significantly higher among H. pylori negative than H. pylori positive subjects at Days 8 and 15 (p < 0.05). Upper GI adverse events were reported by 18 (5.7%) subjects in the risedronate group (19 events) and 28 (8.8%) subjects in the alendronate group (32 events). Symptoms did not predict the presence of mucosal damage. CONCLUSION: Risedronate was associated with a significantly lower incidence of gastric ulcers than alendronate. H. pylori infection did not increase the incidence of bisphosphonate related gastric ulcers. The findings from this 14 day study in healthy volunteers support the hypothesis that bisphosphonates may differ from one another in their potential to produce upper GI mucosal damage.
|
https://pubmed.ncbi.nlm.nih.gov/12233894/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Multicenter Study",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12233894
|
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] |
12,233,968 |
Use of intercostal bupivacaine with epinephrine after surgery to decrease use of narcotics and duration of intubation.
|
Fox William J WJ, Hughes Thomas A TA
|
American journal of critical care : an official publication, American Association of Critical-Care Nurses . Vol. 11, No. 5, 2002 Sep
|
BACKGROUND: Postoperative pain plays a significant part in the recovery of patients after open heart surgery. OBJECTIVE: To determine if the use of intercostal bupivacaine with epinephrine is associated with decreases in use of narcotics and intubation times after open heart surgery. METHODS: A randomly selected experimental group of 25 patients received injections of bupivacaine with epinephrine in the intercostal tissues before chest closure in open heart surgery. A control group of 22 patients received no bupivacaine, only standard care. Postoperative use of narcotics and intubation times were determined for both groups. RESULTS: Compared with the control group, the group given bupivacaine with epinephrine used significantly less narcotics (P=.008) and had significantly shorter intubation times (P=.003). CONCLUSION: Injection of intercostal bupivacaine with epinephrine before chest closure in open heart surgery decreases use of narcotics and length of intubation postoperatively, thus speeding up recovery times.
|
https://pubmed.ncbi.nlm.nih.gov/12233968/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12233968
|
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] |
12,233,984 |
Contingent monetary reinforcement of smoking reductions, with and without transdermal nicotine, in outpatients with schizophrenia.
|
Tidey Jennifer W JW, O'Neill Suzanne C SC, Higgins Stephen T ST
|
Experimental and clinical psychopharmacology . Vol. 10, No. 3, 2002 Aug
|
This study was conducted to examine the effects of contingent monetary reinforcement (CM) for smoking reduction, with and without transdermal nicotine, on cigarette smoking in individuals with schizophrenia. Fourteen outpatients participated in each of 3 conditions: (a) CM combined with 21 mg transdermal nicotine, (b) CM combined with placebo patch, and (c) noncontingent reinforcement combined with placebo patch. Each condition lasted 5 days. Carbon monoxide levels were measured 3 times daily, and nicotine withdrawal symptoms were measured once daily in each condition. Results indicated that CM reduced smoking but that 21 mg transdermal nicotine did not enhance that effect. These results offer further evidence supporting the efficacy of CM for reducing smoking among people with schizophrenia, but higher doses of nicotine replacement therapy, or another pharmacotherapy, may be needed to enhance that effect.
|
https://pubmed.ncbi.nlm.nih.gov/12233984/
|
[
"Clinical Trial",
"Controlled Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, P.H.S."
] |
12233984
|
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] |
12,233,983 |
A reinforcement-based therapeutic workplace for the treatment of drug abuse: three-year abstinence outcomes.
|
Silverman Kenneth K, Svikis Dace D, Wong Conrad J CJ, Hampton Jacqueline J, Stitzer Maxine L ML, Bigelow George E GE
|
Experimental and clinical psychopharmacology . Vol. 10, No. 3, 2002 Aug
|
Long-term Therapeutic Workplace effects were evaluated in heroin- and cocaine-dependent, unemployed, treatment-resistant young mothers. Participants were paid to work or to train in the Therapeutic Workplace but had to provide drug-free urine samples to gain daily access. Participants (N = 40) were randomly assigned to a Therapeutic Workplace or usual care control group. Therapeutic Workplace participants could work for 3 years. Relative to controls, Therapeutic Workplace participants increased cocaine (28% vs. 54% negative; p = .04) and opiate (37% vs. 60% negative; p = .05) abstinence on the basis of monthly urine samples collected until 3 years after intake. The Therapeutic Workplace can be an effective long-term treatment of cocaine and heroin addiction in poor and chronically unemployed young mothers.
|
https://pubmed.ncbi.nlm.nih.gov/12233983/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, U.S. Gov't, P.H.S."
] |
12233983
|
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] |
12,233,986 |
Using latent-variable models to analyze smoking cessation clinical trial data: an example among the methadone maintained.
|
Frosch Dominick L DL, Stein Judith A JA, Shoptaw Steve S
|
Experimental and clinical psychopharmacology . Vol. 10, No. 3, 2002 Aug
|
The relationship between tobacco and illicit drug use was examined among 166 methadone-maintained persons participating in a smoking cessation intervention. Latent-growth latent-variable models showed a significant relationship during treatment between rates of change in heroin and rates of change in tobacco use, with increased heroin use corresponding with increased tobacco use. Although levels of cocaine use were related to levels of tobacco use, there was no significant relationship between the rates of change of the 2 substances. A more traditional longitudinal structural equation model demonstrated a significant relationship between more heroin use during treatment and negative smoking cessation outcomes at 6-month follow-up. Findings demonstrate the utility of latent-growth models for analyzing short-term clinical trial data and strongly suggest that successful smoking cessation in this population requires a concurrent focus on reducing heroin use.
|
https://pubmed.ncbi.nlm.nih.gov/12233986/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, U.S. Gov't, P.H.S."
] |
12233986
|
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] |
12,233,988 |
Carbamazepine in the treatment of cocaine dependence: subtyping by affective disorder.
|
Brady Kathleen T KT, Sonne Susan C SC, Malcolm Robert J RJ, Randall Carrie L CL, Dansky Bonnie S BS, Simpson Kit K, Roberts James S JS, Brondino Michael M
|
Experimental and clinical psychopharmacology . Vol. 10, No. 3, 2002 Aug
|
Studies investigating carbamazepine (CBZ) in the treatment of cocaine dependence have been inconsistent. In this study, cocaine-dependent individuals with (n = 57) and without (n = 82) affective disorder were compared in a 12-week, double-blind, placebo-controlled trial. Urine drug screens (UDS) and self-report of drug use were collected weekly. Affective symptoms were measured monthly. Subjects receiving CBZ attended more medication sessions (p = .03). The CBZ-treated affective group had a trend toward fewer cocaine-positive UDS (p = .08) and a significantly longer time to first cocaine use (p = .06). CBZ treatment did not have any impact on cocaine use in individuals without affective disorders.
|
https://pubmed.ncbi.nlm.nih.gov/12233988/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, U.S. Gov't, P.H.S."
] |
12233988
|
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] |
12,233,989 |
Double-blind placebo-controlled trial of methylphenidate in the treatment of adult ADHD patients with comorbid cocaine dependence.
|
Schubiner Howard H, Saules Karen K KK, Arfken Cynthia L CL, Johanson Chris-Ellyn CE, Schuster Charles R CR, Lockhart Nancy N, Edwards Ann A, Donlin Judy J, Pihlgren Eric E
|
Experimental and clinical psychopharmacology . Vol. 10, No. 3, 2002 Aug
|
In this 12-week double-blind placebo-controlled trial of methylphenidate (MTP) versus placebo in 48 cocaine-dependent attention-deficit/hyperactivity disorder (ADHD) adults, the authors sought to determine whether MTP would be safe, control ADHD symptoms, and affect cocaine use. Efficacy indexes revealed significantly greater ADHD symptom relief in the MTP group. There were no group differences in self-reported cocaine use, urinalysis results, or cocaine craving. Because of the relatively small sample size, the results are preliminary. However, we found that MTP improved subjective reports of ADHD symptoms and did not worsen cocaine use while participants were in treatment.
|
https://pubmed.ncbi.nlm.nih.gov/12233989/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, P.H.S."
] |
12233989
|
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] |
12,233,987 |
Multimodal evaluation of risperidone for destructive behavior: functional analysis, direct observations, rating scales, and psychiatric impressions.
|
Valdovinos Maria G MG, Napolitano Deborah A DA, Zarcone Jennifer R JR, Hellings Jessica A JA, Williams Dean C DC, Schroeder Stephen R SR
|
Experimental and clinical psychopharmacology . Vol. 10, No. 3, 2002 Aug
|
Risperidone, an atypical neuroleptic, has become a popular option for treating destructive behaviors of persons with developmental disabilities. A few studies have been conducted that evaluate the effects of risperidone on destructive behavior; however, none of these studies have combined objective measures with rating scales to evaluate the effects of risperidone on destructive behavior across home and clinical settings. This study evaluated the wide range of effects of risperidone on destructive behavior of 2 persons with developmental disabilities using weekly functional analysis sessions, daily observations, hourly home data, weekly rating scales, and monthly psychiatric impressions. Results indicate that risperidone does decrease destructive behavior and that, for the most part, all of the various measures yielded similar results.
|
https://pubmed.ncbi.nlm.nih.gov/12233987/
|
[
"Case Reports",
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, U.S. Gov't, P.H.S."
] |
12233987
|
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] |
12,233,990 |
Do men outperform women in smoking cessation trials? Maybe, but not by much.
|
Killen Joel D JD, Fortmann Stephen P SP, Varady Ann A, Kraemer Helena C HC
|
Experimental and clinical psychopharmacology . Vol. 10, No. 3, 2002 Aug
|
Using data from 4 smoking cessation trials conducted from 1988 to 2000, the authors investigated whether men are more successful than women in quitting smoking. Odds ratios indicated that the abstinence rates were not significantly different for men and women. Thus, there may be little value to diverting research funds from efforts to develop more effective treatments for both men and women to efforts to explain a very small gender effect associated with existing treatments. However, it may be appropriate to make gender comparisons for new therapies for nicotine dependence. The authors recommend against analyses of gender differences in studies that do not account for gender in their research designs.
|
https://pubmed.ncbi.nlm.nih.gov/12233990/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, P.H.S."
] |
12233990
|
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] |
12,233,993 |
Examining possible gender differences among cocaine-dependent outpatients.
|
Wong Conrad J CJ, Badger Gary J GJ, Sigmon Stacey C SC, Higgins Stephen T ST
|
Experimental and clinical psychopharmacology . Vol. 10, No. 3, 2002 Aug
|
Potential differences in sociodemographics, drug use, and measures of treatment outcome were examined among 137 male and 51 female cocaine-dependent outpatients. More women than men were unemployed, received public assistance, and were living with their children. Women reported fewer years of regular cocaine use, spending less money per week on cocaine, less prior treatment for cocaine abuse, and were more likely than men to test positive for cocaine at intake. With respect to other drug use, fewer women than men reported using sedatives and tested positive for sedatives at intake. Women reported a lower frequency of alcohol use before intake, and fewer women than men met criteria for cannabis dependence. Men and women experienced comparable improvement during the course of treatment and follow-up.
|
https://pubmed.ncbi.nlm.nih.gov/12233993/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, U.S. Gov't, P.H.S."
] |
12233993
|
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] |
12,233,994 |
Nonproblem drinking outcomes in adolescents treated for alcohol use disorders.
|
Maisto Stephen A SA, Martin Christopher S CS, Pollock Nancy K NK, Cornelius Jack R JR, Chung Tammy A TA
|
Experimental and clinical psychopharmacology . Vol. 10, No. 3, 2002 Aug
|
Change to nonproblem drinking was studied in 159 adolescents (70% male) presenting for alcohol use disorders (AUDs) treatment. A community sample (n = 148,47% male) also was assessed. Clinical participants had a current AUD at baseline; 1 year later, 17% remained abstinent, 60% had at least 1 AUD symptom (problem drinkers), and 23% were drinking but had no AUD symptoms (nonproblem drinkers). Drinking among the nonproblem drinkers decreased and was lower than in the problem drinkers. Nonproblem drinkers increased in psychosocial functioning and decreased in the number of illicit drugs used relative to problem drinkers and generally did not differ from the abstainers. The results suggest alternative views of treatment goals, relapse, and treatment outcome in adolescents.
|
https://pubmed.ncbi.nlm.nih.gov/12233994/
|
[
"Clinical Trial",
"Journal Article",
"Research Support, U.S. Gov't, P.H.S."
] |
12233994
|
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] |
12,234,028 |
Does famotidine enhance tumor infiltrating lymphocytes in breast cancer? Results of a randomized prospective pilot study.
|
Parshad Rajinder R, Kapoor Sorabh S, Gupta Siddhartha Datta SD, Kumar Arvind A, Chattopadhyaya Tushar K TK
|
Acta oncologica (Stockholm, Sweden) . Vol. 41, No. 4, 2002
|
Thirty patients with breast cancer were prospectively randomized into case and control groups receiving 40 mg famotidine preoperatively for 10-14 days and routine premedication, respectively. Surgical specimens were evaluated objectively for tumor infiltrating lymphocytes in the center and in the periphery of the tumor along with evaluation of metastatic lymph nodes for reactive changes. Ten famotidine-treated cases (67%) showed significant lymphocytic infiltration in the center compared to 4 controls (27%) (p = 0.03). Eleven cases (77%) had significant lymphocytic infiltration in the periphery (p = 0.03) compared to 5 controls (33%). Considering both sites, lymphocytic response was significant in 9 (60%) cases as opposed to only 3 (20%) controls (p = 0.03). This response did not correlate with the stage, grade of tumor or menopausal status of patients in either group. Seventy-eight percent (78%) of the cases showed significant reactive changes in the metastatic lymph nodes as compared to 22% in controls (p < 0.01). This study suggests that famotidine enhances tumor infiltrating lymphocytes in breast cancer and might have potential as an immunomodulator. A larger confirmatory study is suggested.
|
https://pubmed.ncbi.nlm.nih.gov/12234028/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial"
] |
12234028
|
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] |
12,234,030 |
Cosmetic outcome and breast morbidity in breast-conserving treatment--results from the Danish DBCG-82TM national randomized trial in breast cancer.
|
Johansen Jørgen J, Overgaard Jens J, Rose Carsten C, Engelholm Svend Aage SA, Gadeberg Carl C CC, Kjaer Mogens M, Kamby Claus C, Juul-Christensen Jens J, Blichert-Toft Mogens M, Overgaard Marie M,
|
Acta oncologica (Stockholm, Sweden) . Vol. 41, No. 4, 2002
|
A total of 266 recurrence-free breast cancer patients from the randomized DBCG-82TM breast conservation trial were called in for a follow-up investigation to study the impact of surgical and radiation treatment factors on the cosmetic and functional outcome after breast conservation. The patients were interviewed and examined after a median follow-up time of 6.6 years, and 194 of them (73%) regarded the cosmetic result as excellent or good. Morbidity assessments showed that breast fibrosis, skin telangiectasia, and breast retraction were significantly associated with a less satisfactory cosmetic result. On univariate analysis, it was found that treatment with a direct anterior electron field produced more morbidity and inferior cosmetic outcomes compared with tangential photon treatment, while increasing breast size was associated with increased breast retraction and breast fibrosis. Treatment characteristics that emerged as independent prognostic factors of a poor cosmetic outcome on multivariate analysis were the use of a direct anterior electron field (OR = 2.15, CI 1.25-3.70) and adjuvant systemic therapy (OR = 2.13, 1.22-3.71). A significant but relatively low level of concordance was found between the patients' and the clinician's evaluations of cosmetic results but self-assessments of breast morbidity and psychological distress were significantly related to the observed treatment-induced side effects after breast-conserving treatment, indicating that subjective perceptions and observations as reported by the patients are relevant for the identification of treatment factors that impact on normal tissue reactions.
|
https://pubmed.ncbi.nlm.nih.gov/12234030/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12234030
|
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] |
12,234,031 |
The Finnish Cancer Registry as follow-up source of a large trial cohort--accuracy and delay.
|
Korhonen Pasi P, Malila Nea N, Pukkala Eero E, Teppo Lyly L, Albanes Demetrius D, Virtamo Jarmo J
|
Acta oncologica (Stockholm, Sweden) . Vol. 41, No. 4, 2002
|
We evaluated the accuracy and time to reporting of cancer diagnoses obtained through the Finnish Cancer Registry (FCR) for the Alpha-Tocopherol Beta-Carotene Cancer Prevention (ATBC) Study in 1985-1997. In the ATBC Study suspect neoplasms were centrally reviewed through medical records and pathology specimens. The FCR data were compared against the reviewed data for 3600 cancers of eight sites. For most sites, 95% of the cases were reported to the FCR within 0.9 years with longer delays for lung and pancreatic cancers. Ninety-six percent of all FCR cases received the same primary site diagnosis in the ATBC review, and in 1.4% no malignancy was found. Conversely, 97% of cancers ascertained in the ATBC review had the same primary site in the FCR and 0.8% were unknown to the Registry. The accuracy of the FCR data is high but the delay in case notification should be considered in epidemiological studies.
|
https://pubmed.ncbi.nlm.nih.gov/12234031/
|
[
"Clinical Trial",
"Journal Article"
] |
12234031
|
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] |
12,234,036 |
Spatial reference and standing posture during high-speed Coriolis stimulation.
|
Hitouji Kayoko K, Takahashi Masahiro M, Iida Masahiro M, Ohnuki Junichi J, Furuya Hiroyuki H
|
Aviation, space, and environmental medicine . Vol. 73, No. 9, 2002 Sep
|
BACKGROUND: In a previous study, we found that sensation, gaze, and posture during Coriolis stimulation differ considerably between vision and nonvision conditions during rotations at 60 degrees x s(-1). To determine the validity of these findings at higher velocities, we compared standing postures during Coriolis stimulation up to 150 degrees x s(-1) between vision and nonvision conditions. METHODS: The 19 subjects underwent 5-min rotation tests at 50 to 150 degrees x s(-1). While standing on a force platform attached to a rotating device, each subject tilted his or her head and then returned it to upright, first with the eyes covered, then with eyes open. Six subjects were re-examined 5 d later after 4 consecutive days of 20-min rotations with their eyes open. We assessed success and failure to stand and recorded the center of pressure during rotation. RESULTS: Although success rates (number of successes/19) differed between vision and nonvision conditions at 50 degrees x s(-1) (94.7% vs. 57.9%), they steeply decreased as rotation velocity increased and showed no difference at 70 degrees x s(-1) and faster velocities. After the 4-d exposure, however, subjects could stand at higher velocities particularly under the vision condition. A patient with bilateral labyrinthine loss, being examined for reference, could stand at 110 degrees x s(-1) even with the eyes covered. CONCLUSIONS: Untrained subjects frequently fell during high-speed Coriolis stimulation, apparently because vision was insufficient to provide a spatial reference frame from the stationary surroundings. Following rotation training with their eyes open, subjects appeared more able to use the visual reference frame and falls were reduced.
|
https://pubmed.ncbi.nlm.nih.gov/12234036/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12234036
|
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] |
12,234,037 |
Moderate exercise after altitude exposure fails to induce decompression sickness.
|
Webb James T JT, Pilmanis Andrew A AA, Fischer Michele D MD
|
Aviation, space, and environmental medicine . Vol. 73, No. 9, 2002 Sep
|
INTRODUCTION: The objective of this study was to determine the effect of exercise after altitude exposure (post-exposure exercise) on subsequent altitude decompression sickness (DCS) incidence. Existing USAF prohibition of exercise following altitude chamber training exposures and interest from operational personnel prompted our evaluation of post-exposure exercise as a DCS-inducing stressor. METHODS: After a 1-h resting preoxygenation, 67 subjects were exposed to 30,000 ft for 2-h while performing mild, upper body exercise. The subjects were monitored for venous gas emboli (VGE) with an echo-imaging system and observed for signs and symptoms of DCS. Subjects without DCS (n = 31) or with DCS which resolved during recompression (n = 29) were randomly assigned to post-exposure rest (control, n = 29) or moderate exercise (50% of peak oxygen uptake, dual-cycle ergometry; n = 31) and both groups were monitored for delayed or recurring DCS. RESULTS: The altitude exposure resulted in 48.3% DCS in the 60 volunteers serving as test or control subjects. Of 31 subjects assigned to the post-exposure exercise group, 15 had developed DCS which resolved during descent. No cases of DCS were observed or reported during or following post-exposure exercise. CONCLUSION: The results show that moderate exercise after exposure did not result in either delayed-onset or recurring DCS.
|
https://pubmed.ncbi.nlm.nih.gov/12234037/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, U.S. Gov't, Non-P.H.S."
] |
12234037
|
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] |
12,234,038 |
Impact of influenza vaccination on civilian aircrew illness and absenteeism.
|
Mixéu Marias A G MA, Vespa Glaucia N R GN, Forleo-Neto Eduardo E, Toniolo-Neto João J, Alves Paulo M PM
|
Aviation, space, and environmental medicine . Vol. 73, No. 9, 2002 Sep
|
BACKGROUND: Approximately 10% of the general population worldwide acquires influenza infection every year. Airline crews run a particularly high risk of contracting influenza and influenza-like viruses because they come in contact with hundreds of potentially infected individuals every day. Respiratory diseases are the most frequent cause of absenteeism among flight crews in airline companies. Several studies have shown the efficacy of influenza vaccination in the workplace of healthy, working adults leading to increased productivity and lower absenteeism. We conducted a double blind, randomized, placebo-controlled study on flight crews of an airline company in order to determine the safety and efficacy of a trivalent inactivated influenza vaccine in reducing illness and absences from work. METHODS: The 813 healthy members of a Brazilian airline company were randomly assigned to receive injections of either an influenza vaccine or a placebo, with a follow-up period of 7 mo after vaccination. Primary outcomes included influenza-like illness episodes and absenteeism from work due to such episodes. RESULTS: Demographic characteristics were similar in the two groups. No significant side-effects occurred in either group. Compared to the placebo group, individuals receiving the vaccine showed 39.5% fewer episodes of flu-like illness (p < 0.001) and 26% fewer days of work lost (p = 0.03). The vaccinated group developed 33% fewer episodes of any severe flu-like illness (p < 0.01). CONCLUSION: The data indicates that influenza vaccination is safe in airline flight crews and may produce health-related benefits including reduced absenteeism.
|
https://pubmed.ncbi.nlm.nih.gov/12234038/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12234038
|
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] |
12,234,056 |
Release of algesic substances in human experimental muscle pain.
|
Tegeder L L, Zimmermann J J, Meller S T ST, Geisslinger G G
|
Inflammation research : official journal of the European Histamine Research Society ... [et al.] . Vol. 51, No. 8, 2002 Aug
|
OBJECTIVE: We employed the 'delayed onset of muscle soreness' (DOMS) and the 'hypertonic saline' muscle pain models in combination with muscle microdialysis to evaluate the role of potentially algesic substances (lactate, glutamate, prostaglandin E2 (PGE2), nitric oxide (NO) and substance P (SP)) in the development of human muscle pain. METHODS: DOMS was induced by 2 sets of 50 concentric/eccentric contractions of the calf muscles 24 h before the start of microdialysis. During microdialysis pain was stimulated through calf muscle contractions (dorsal and plantar flexions of the foot). Hypertonic saline was injected into the biceps muscle (5 x 200 microl 5.8% NaCl, 2 min interval) during dialysis. The calf (no treatment) and biceps (normal saline) of the other side was used as control. RESULTS: Both models reliably induced muscle pain with similar intensities as assessed by visual analog scale. The DOMS exercise caused an increase of lactate in serum and the calf muscles of the DOMS leg. In addition, glutamate, PGE2 and substance P dialysate concentrations increased following contraction-induced pain stimulation (peak concentrations 125 +/- 20 microM, 239 +/- 45 pg/ml and 60 +/- 11 pg/ml for glutamate, PGE2 and SP, respectively). This increase did not occur in the control leg (peak concentrations 97 +/- 12 microM, 114 +/- 26 pg/ml and 46 +/- 9 pg/ml for glutamate, PGE2 and SP, respectively). Concentrations of nitric oxide were lower in the DOMS than control leg, particularly during the first 4h of microdialysis. Injection of hypertonic saline into the biceps muscle caused a significant increase of dialysate glutamate concentrations (peak 50 +/- 3 microM) whereas glutamate remained constant after injection of normal saline (mean 26 +/- 1 microM). Injection of hypertonic saline had no effect on lactate, PGE2 or NO levels. CONCLUSION: Our data support the notion that an inflammatory reaction may be involved in muscle soreness following eccentric exercise, whereas the injection of hypertonic saline into the muscle probably directly stimulates muscle nociceptors and causes glutamate release.
|
https://pubmed.ncbi.nlm.nih.gov/12234056/
|
[
"Clinical Trial",
"Controlled Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12234056
|
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] |
12,234,087 |
Muscle weakness and cocontraction in upper limb hemiparesis: relationship to motor impairment and physical disability.
|
Chae John J, Yang Guang G, Park Byung Kyu BK, Labatia Ihab I
|
Neurorehabilitation and neural repair . Vol. 16, No. 3, 2002 Sep
|
The purpose of this article is to describe the relationship between poststroke upper limb muscle weakness and cocontraction, and clinical measures of upper limb motor impairment and physical disability. Electrormyographic (EMG) activity of the paretic and nonparetic wrist flexors and extensors of 26 chronic stroke survivors were recorded during isometric wrist flexion and extension. The root mean square (RMS) of the EMG signal was used as a measure of strength of contraction. A ratio of RMS of antagonist and agonist muscles was used as a measure of cocontraction. Upper limb motor impairment and physical disability were assessed with the Fugl-Meyer motor assessment (FMA) and the arm motor ability test (AMAT), respectively. The strength of muscle contraction was significantly stronger in the nonparetic limb (P < 0.001). The degree of cocontraction was significantly greater in the paretic limb (P < 0.001). The strength of muscle contraction in the paretic limb correlated significantly with FMA (r = 0.62 to 0.87, P < or = 0.001) and AMAT (r = 0.66 to 0.80, P < or = 0.001) scores. Similarly, the degree of cocontraction correlated significantly with FMA (r = -0. 70 to -0.64, P < or = 0.001) and AMAT (r = -0. 72 to -0.62, P < or = 0.001) scores. Muscle weakness and degree of cocontraction correlate significantly with motor impairment and physical disability in upper limb hemiplegia. This relationship may provide insights toward development of specific interventions. However, additional studies are needed to demonstrate a cause and effect relationship.
|
https://pubmed.ncbi.nlm.nih.gov/12234087/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, P.H.S."
] |
12234087
|
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] |
12,234,089 |
Hand motor recovery after stroke: a transcranial magnetic stimulation mapping study of motor output areas and their relation to functional status.
|
Bastings Eric P EP, Greenberg Jason P JP, Good David C DC
|
Neurorehabilitation and neural repair . Vol. 16, No. 3, 2002 Sep
|
The respective contributions of the stroke and undamaged hemispheres to motor recovery after stroke remains controversial. The aim of this article is to evaluate the relationship between location and size of cortical motor areas and outcome after stroke. Twelve controls and 12 stroke patients were studied. Hand cortical motor output areas were determined using transcranial magnetic stimulation. Motor-evoked potentials were recorded simultaneouslyfrom both hands. Functional motor abilities were evaluated using well-validated measures. Surface area, weighted surface area, and center of gravity of motor output areas were calculated. Different patterns of motor output areas to the paretic band were observed; there was no motor output from the stroke hemisphere in patients with poor outcome, contrasting to large motor output area in the stroke hemisphere in patients with good outcome, regardless of infarct size or location. A significant correlation was found between measures of motor outcome in the stroke-affected upper extremity and both the surface area and weight of the central motor output area in the stroke hemisphere. No ipsilateral motor response was obtained after stimulation of either hemisphere. These data support an association between preservation of cortical motor output area to the paretic hand in the stroke hemisphere and good motor outcome.
|
https://pubmed.ncbi.nlm.nih.gov/12234089/
|
[
"Clinical Trial",
"Journal Article",
"Research Support, U.S. Gov't, P.H.S."
] |
12234089
|
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] |
12,234,090 |
Assessing the motor status score: a scale for the evaluation of upper limb motor outcomes in patients after stroke.
|
Ferraro Mark M, Demaio Jennifer Hogan JH, Krol Jennifer J, Trudell Chris C, Rannekleiv Keren K, Edelstein Lisa L, Christos Paul P, Aisen Mindy M, England Jill J, Fasoli Susan S, Krebs H I HI, Hogan N N, Volpe Bruce T BT
|
Neurorehabilitation and neural repair . Vol. 16, No. 3, 2002 Sep
|
The Motor Status Scale (MSS) measures shoulder, elbow (maximum score = 40), wrist, hand, and finger movements (maximum score = 42), and expands the measurement of upper extremity impairment and disability provided by the Fugl-Meyer (FM) score. This work examines the interrater reliability and criterion validity of the MSS performed in patients admitted to a rehabilitation hospital 21 +/- 4 days after stroke. Using the MSS and the FM, 7 occupational therapists masked to each other's judgments, evaluated 12 consecutive patients with stroke. Two therapists evaluated 6 additional patients on consecutive days. Intraclass correlation coefficients were significant for each group of raters for the shoulder/elbow and for the wrist/band (P < 0.0001); test-retest measures were also significant for the shoulder/elbow (Pearson correlation coefficient r = 0.99, P < 0.004) and for the wrist/hand (Pearson correlation coefficient r = 0.99, P < 0.003). The internal item consistency for the overall MSS was significant (Cronbach alpha = 0.98, P < 0.0001). Finally the correlation between the MSS and the FM (R2 = 0.964) was significant (P < 0.0001). The MSS affords a reliable and valid assessment of upper limb impairment and disability following stroke.
|
https://pubmed.ncbi.nlm.nih.gov/12234090/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, P.H.S."
] |
12234090
|
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0.27992063760757446,
-0.04526787996292114,
-0.061543986201286316
] |
12,234,091 |
Modified constraint-induced therapy after subacute stroke: a preliminary study.
|
Page Stephen J SJ, Sisto SueAnn S, Johnston Mark V MV, Levine Peter P
|
Neurorehabilitation and neural repair . Vol. 16, No. 3, 2002 Sep
|
OBJECTIVE: To determine the efficacy of a modified constraint-induced therapy (mCIT) administered to patients with subacute stroke. DESIGN: Prospective, multiple-baseline, before-after, randomized clinical trial. SETTING: Subacute outpatient clinic. SUBJECTS: Fourteen patients with subacute stroke who exhibited learned nonuse and stable motor deficits in their affected upper limbs. INTERVENTION: Four patients participated in half-hour, structured physical and occupational therapy sessions that emphasized affected arm use in valued functional activities, 3 times per week for 10 weeks. Their less affected upper limbs were restrained 5 days per week during 5 hours identified as times of frequent use (mCIT). Five patients received regular therapy (TR) with similar therapeutic contact time to mCIT and 5 patients received no therapy (CON). MAIN OUTCOME MEASURES: The Fugl-Meyer Assessment of Motor Recovery (Fugl), Action Research Arm (ARA) test, and Motor Activity Log (MAL). RESULTS: After intervention, Fugl, ARA, and MAL scores remained virtually the same for TR and CON groups; scores improved by 11.4 and 11.5points, respectively, on the Fugl and ARA for the mCIT group. Amount and quality of arm use, as measured by the MAL, also improvedfor mCIT patients (2.49 and 0.47, respectively). CONCLUSIONS: mCIT may be an efficacious method of improving affected arm function and use in stroke patients exhibiting learned nonuse.
|
https://pubmed.ncbi.nlm.nih.gov/12234091/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, U.S. Gov't, Non-P.H.S."
] |
12234091
|
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] |
12,234,167 |
Phase II study of a moderate-intensity preparative regimen with allogeneic peripheral blood stem cell transplantation for hematologic diseases: the Texas Transplant Consortium experience.
|
Shaughnessy P J PJ, Ornstein D D, Ririe D D, Callander N N, Anderson J E JE, Pollack M S MS, Freytes C O CO, Cruz J J, Rodriquez T T, Bachier C C, LeMaistre C F CF
|
Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation . Vol. 8, No. 8, 2002
|
Conventional preparative regimens for allogeneic stem cell transplantation are associated with excessive regimen-related toxicity (RRT) in some patients because of underlying comorbidities, advanced age, or prior treatment. We studied a preparative regimen designed to reduce RRT, yet allow for adequate engraftment and development of a graft-versus-malignancy effect. Thirty patients (median age, 57 years) were entered on study. Twenty-nine patientsreceived stem cells from HLA-identical siblings and 1 from a sibling mismatched for 1 antigen at the A locus. Sixteen patients had received previous stem cell transplants (6 allogeneic and 10 autologous). The preparative regimen consisted of fludarabine 30 mg/M2 per day IV on day -10 to day -5, busulfan 1 mg/kg per dose PO (n = 6) or 0.8 mg/kg per dose IV (n = 24) for 8 doses every 6 hours on day -6 to day -5, and horse-derived antithymocyte globulin 5 mg/kg per day IV (n = 12) or 15 mg/kg per day IV (n = 18) on day -4 to day -1. GVHD prophylaxis consisted of cyclosporine (CYA) 3 mg/kg BID PO starting on day -3 (n = 13) or CYA and methotrexate 15 mg/m2 IV on day +1 and 10 mg/m2 IV on day +3 and day +6 (n = 17). The median number of CD34 cells transplanted was 3.19 x 10(6)/kg. All patients demonstrated recovery of hematopoietic function. Twenty-six (89%) of 29 evaluable patients achieved greater than 90% donor cell chimerism before day 100. Three patients never achieved greater than 90% donor chimerism, and another 3 patients subsequently lost donor chimerism. All 6 of these patients had autologous reconstitution with progressive disease. RRT was minimal; 7 patients had greater than grade II nonhematologic toxicity and there were no toxic deaths attributable to the conditioning regimen. Transplantation-related mortality was 7% (95% confidence interval [CI], 6%-8%) at 3 months and 28% (95% CI, 23%-34%) at 12 months after transplantation. Non-relapse-related mortality was most often due to infection. Grade II or greater GVHD developed in 56% of evaluable patients, and all patients with disease response developed GVHD. Actuarial estimates of overall and disease-free survival at 12 months were 52% (95% CI, 43%-63%) and 30% (95% CI, 24%-37%), respectively. Although this preparative regimen allowed adequate engraftment with minimal RRT, GVHD and infectious complications caused significant morbidity and mortality. Further study to define appropriate patient populations for this regimen, while limiting GVHD and infection risks, is needed.
|
https://pubmed.ncbi.nlm.nih.gov/12234167/
|
[
"Clinical Trial",
"Clinical Trial, Phase II",
"Journal Article",
"Multicenter Study",
"Research Support, Non-U.S. Gov't"
] |
12234167
|
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] |
12,234,168 |
Effective purging of autologous hematopoietic stem cells using anti-B-cell monoclonal antibody-coated high-density microparticles prior to high-dose therapy for patients with non-Hodgkin's lymphoma.
|
Webb Iain J IJ, Friedberg nathan W nW, Gribben John G JG, Fisher David C DC, Spitzer Thomas T, Neuberg Donna D, Jallow Haddy H, Kim Helen H, Houde Heather H, Monroy Ron R, Schmittling Robert R, Freedman Arnold S AS
|
Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation . Vol. 8, No. 8, 2002
|
Contamination of hematopoietic stem cells (HSCs) with tumor cells has been associated with increased incidence of relapse in patients with non-Hodgkin's lymphoma following autologous HSC transplantation. Effective purging of tumor cells may improve the results of HSC transplantation, but current methods of purging are technically difficult to perform with large numbers of cells and do not consistently remove all detectable cells. We report a pilot clinical trial in which 10 patients with relapsed B-cell non-Hodgkin's lymphoma received high-dose chemotherapy followed by infusion of autologous HSCs depleted of B-cells by high-density microparticles (HDM) coated with anti-CD19 and anti-CD20 monoclonal antibodies (BCell-HDM). HSCs were mobilized with cyclophosphamide and granulocyte colony-stimulating factor. In 6 of the 10 patients, B-cells were detectable by immunocytochemical analysis of the apheresis products prior to treatment. Following treatment with the BCell-HDM, no B-cells were detected in the products from 5 of these patients, a result representing a median depletion of >2.2 logs (range, >0.4 to >5.1 logs). The median recovery of nontarget cells postdepletion was 73% for CD34 cells and 78% for CD3+ cells. All patients received high-dose cyclophosphamide, BCNU (carmustine), and etoposide prior to reinfusion of their B-cell-depleted autologous HSCs. The median number of CD34+ cells cryopreserved was 3.6 x 10(6) cells/kg (range, 2.2-10.1 x 10(6) cells/kg). Engraftment was rapid in all cases, with a median time to achieve an absolute neutrophil count of 0.5 x 10(9)/L of 10 days (range, 8-11 days). The median time to achieve a platelet count of 20 x 10(9)/L unsupported by platelet transfusion was 11.5 days (range, 8-17 days). This nonmagnetic negative-depletion technology is simple, rapid, and effective in depleting target cells to undetectable levels, with excellent recovery of nontarget cells.
|
https://pubmed.ncbi.nlm.nih.gov/12234168/
|
[
"Clinical Trial",
"Journal Article",
"Research Support, U.S. Gov't, P.H.S."
] |
12234168
|
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] |
12,234,230 |
Ultrasound-guided extracorporeal shock wave therapy for plantar fasciitis: a randomized controlled trial.
|
Buchbinder Rachelle R, Ptasznik Ronnie R, Gordon Jeanine J, Buchanan Joylene J, Prabaharan Vasuki V, Forbes Andrew A
|
JAMA . Vol. 288, No. 11, 2002 Sep 18
|
CONTEXT: Extracorporeal shock wave therapy (ESWT) is increasingly used for plantar fasciitis, but limited evidence supports its use. OBJECTIVE: To determine whether ultrasound-guided ESWT reduces pain and improves function in patients with plantar fasciitis. DESIGN: Double-blind, randomized, placebo-controlled trial conducted between April 1999 and June 2001. SETTING: Participants were recruited from the community-based referring physicians (primary care physicians, rheumatologists, orthopedic surgeons, and sports physicians) of a radiology group in Melbourne, Australia. PARTICIPANTS: We screened 178 patients and enrolled 166; 160 completed the 15-week protocol. Entry criteria included age at least 18 years with plantar fasciitis, defined as heel pain maximal over the plantar aspect of the foot of at least 6 weeks' duration, and an ultrasound-confirmed lesion, defined as thickening of the origin of the plantar fascia of at least 4 mm, hypoechogenicity, and alterations in the normal fibrillary pattern. INTERVENTIONS: Patients were randomly assigned to receive either ultrasound-guided ESWT given weekly for 3 weeks to a total dose of at least 1000 mJ/mm(2) (n = 81), or identical placebo to a total dose of 6.0 mJ/mm(2) (n = 85). MAIN OUTCOME MEASURES: Overall, morning, and activity pain, measured on a visual analog scale; Maryland Foot Score; walking ability; Short-Form-36 Health Survey (SF-36) score; and Problem Elicitation Technique score, measured at 6 and 12 weeks after treatment completion. RESULTS: At 6 and 12 weeks, there were significant improvements in overall pain in both the active group and placebo group (mean [SD] improvement, 18.1 [30.6] and 19.8 [33.7] at 6 weeks [P =.74 for between-group difference], and 26.3 [34.8] and 25.7 [34.9] at 12 weeks [P =.99], respectively). Similar improvements in both groups were also observed for morning and activity pain, walking ability, Maryland Foot Score, Problem Elicitation Technique, and SF-36. There were no statistically significant differences in the degree of improvement between treatment groups for any measured outcomes. CONCLUSION: We found no evidence to support a beneficial effect on pain, function, and quality of life of ultrasound-guided ESWT over placebo in patients with ultrasound-proven plantar fasciitis 6 and 12 weeks following treatment.
|
https://pubmed.ncbi.nlm.nih.gov/12234230/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12234230
|
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] |
12,234,231 |
Effectiveness of nurses as providers of birth labor support in North American hospitals: a randomized controlled trial.
|
Hodnett Ellen D ED, Lowe Nancy K NK, Hannah Mary E ME, Willan Andrew R AR, Stevens Bonnie B, Weston Julie A JA, Ohlsson Arne A, Gafni Amiram A, Muir Holly A HA, Myhr Terri L TL, Stremler Robyn R,
|
JAMA . Vol. 288, No. 11, 2002 Sep 18
|
CONTEXT: North American cesarean delivery rates have risen dramatically since the 1960s, without concomitant improvements in perinatal or maternal health. A Cochrane Review concluded that continuous caregiver support during labor has many benefits, including reduced likelihood of cesarean delivery. OBJECTIVE: To evaluate the effectiveness of nurses as providers of labor support in North American hospitals. DESIGN: Randomized controlled trial with prognostic stratification by center and parity. Women were enrolled during a 2-year period (May 1999 to May 2001) and followed up until 6 to 8 postpartum weeks. SETTING: Thirteen US and Canadian hospitals with annual cesarean delivery rates of at least 15%. PARTICIPANTS: A total of 6915 women who had a live singleton fetus or twins, were 34 weeks' gestation or more, and were in established labor at randomization. INTERVENTION: Patients were randomly assigned to receive usual care (n = 3461) or continuous labor support by a specially trained nurse (n = 3454) during labor. MAIN OUTCOME MEASURES: The primary outcome measure was cesarean delivery rate. Other outcomes included intrapartum events and indicators of maternal and neonatal morbidity, both immediately after birth and in the first 6 to 8 postpartum weeks. RESULTS: Data were received for all 6915 women and their infants (n = 6949). The rates of cesarean delivery were almost identical in the 2 groups (12.5% in the continuous labor support group and 12.6% in the usual care group; P =.44). There were no significant differences in other maternal or neonatal events during labor, delivery, or the hospital stay. There were no significant differences in women's perceived control during childbirth or in depression, measured at 6 to 8 postpartum weeks. All comparisons of women's likes and dislikes, and their future preference for amount of nursing support, favored the continuous labor support group. CONCLUSIONS: In hospitals characterized by high rates of routine intrapartum interventions, continuous labor support by nurses does not affect the likelihood of cesarean delivery or other medical or psychosocial outcomes of labor and birth.
|
https://pubmed.ncbi.nlm.nih.gov/12234231/
|
[
"Clinical Trial",
"Journal Article",
"Multicenter Study",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, P.H.S."
] |
12234231
|
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12,234,308 |
Oral L-arginine does not improve endothelial dysfunction in children with chronic renal failure.
|
Bennett-Richards Katy J KJ, Kattenhorn Mia M, Donald Ann E AE, Oakley Gillian R GR, Varghese Zac Z, Bruckdorfer K Richard KR, Deanfield John E JE, Rees Lesley L
|
Kidney international . Vol. 62, No. 4, 2002 Oct
|
BACKGROUND: Cardiovascular disease is a major cause of mortality amongst patients with chronic renal failure (CRF). L-arginine has been used to improve endothelial function by increasing nitric oxide (NO) bioavailability and in animal models this in turn has attenuated the progression of atherosclerosis. We examined whether dietary L-arginine supplementation improved endothelial function in children with CRF. METHODS: A randomized, double-blind, placebo-controlled, crossover trial of L-arginine was conducted in 21 normotensive children aged 11.5 +/- 3 (7 to 17) years with CRF (GFR 27.4 +/- 13.2 mL/min/1.73 m(2)) in whom endothelial dysfunction had previously been demonstrated. We examined the effect of L-arginineon the endothelial response to shear stress (NO-dependent) using a non-invasive technique of high-resolution ultrasound. Each subject was studied before and after 4 weeks of L-arginine (2.5 g/m(2) or 5 g/m(2) x 3/day) or placebo, separated by a rest period of 4 weeks. Brachial artery diameter was measured at rest, during increased flow (endothelial-dependent dilation) and after 25 microg of glyceryl trinitrate (endothelial-independent dilation) at each visit. RESULTS: After oral L-arginine, plasma L-arginine levels rose from 82 +/- 20 to 179 +/- 110 micromol/L (P < 0.001). No significant change in endothelial-dependent dilation during L-arginine (7.96 +/- 2.35 to 7.71 +/- 3.22%; P> 0.05) or placebo (8.2 +/- 2.89 to 8.3 +/- 3.14%; P> 0.05) was noted. There was no change in endothelial-independent dilation. CONCLUSION: Endothelial function was not improved with L-arginine, suggesting that dietary supplementation is not a useful clinical approach in children with CRF.
|
https://pubmed.ncbi.nlm.nih.gov/12234308/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12234308
|
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] |
12,234,429 |
Anterior microforaminotomy for treatment of cervical radiculopathy: part 1--disc-preserving "functional cervical disc surgery".
|
Jho Hae-Dong HD, Kim Woo-Kyung WK, Kim Myung-Hyun MH
|
Neurosurgery . Vol. 51, No. 5 Suppl, 2002 Nov
|
OBJECTIVE: Anterior cervical microforaminotomy was developed by the senior author (H-DJ) under the concept of "functional spine surgery which directly eliminates compressive pathological factors while preserving functional anatomic features. The surgical results are reported. METHODS: Among approximately 400 patients who underwent anterior cervical microforaminotomy at the University of Pittsburgh between March 1993 and May 1999, 104 patients met the inclusion criteria for this study. Forty-five patients were men and 59 were women. Patient ages ranged from 26 to 74 years (median, 46 yr). Compressive pathological lesions included spondylotic spurs in 44 cases (42.3%), soft disc herniation in 54 cases (51.9%), and a combination of the two in 6 cases (5.8%). RESULTS: Eighty-three patients (79.8%) experienced excellent results, 20 patients (19.2%) experienced good results, and 1 patient experienced fair results. No patient demonstrated a poor or unchanged outcome. All patients demonstrated excellent decompression in their postoperative magnetic resonance imaging scans, and all patients except one with discitis maintained their motion segments well, as indicated in postoperative dynamic roentgenograms. Two patients developed transient Horner's syndrome, one patient developed transient hemiparesis, and one patient developed discitis, resulting in spontaneous bone fusion. CONCLUSION: Anterior microforaminotomy provided good or excellent outcomes, with minimal morbidities, for 98% of 104 patients with cervical discogenic radiculopathy. The functional anatomic features were well preserved for 99% of the patients.
|
https://pubmed.ncbi.nlm.nih.gov/12234429/
|
[
"Clinical Trial",
"Journal Article"
] |
12234429
|
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] |
12,234,428 |
Minimally invasive cervical microendoscopic foraminotomy: an initial clinical experience.
|
Fessler Richard G RG, Khoo Larry T LT
|
Neurosurgery . Vol. 51, No. 5 Suppl, 2002 Nov
|
OBJECTIVE: We have previously reported the feasibility of using the microendoscopic foraminotomy (MEF) technique in a cadaveric study. We now report our initial clinical experience with this novel technique. METHODS: From March 1998 to January 2001, we prospectively used the MEF technique in 25 patients with cervical root compression from either foraminal stenosis or disc herniation. The patients' demographic, clinical presentation, surgical, and outcome data were recorded. Another 26 patients treated via open cervical laminoforaminotomy were used for comparison. RESULTS: MEF cases involved less blood loss (138 versus 246 ml per level). MEF patients recovered more rapidly, had a shorter postoperative stay (20 versus 68 hours), and needed fewer narcotics (11 versus 40 equivalents). There were two durotomies after MEF. Overall, our initial experience with the MEF procedure yielded symptomatic improvement for approximately 87 to 92% of patients, depending on which symptom was analyzed. After MEF (mean follow-up, 16 mo; minimum follow-up, 1 year), patients with radiculopathy experienced resolution of their symptoms in 54%, improvement in 38%, and no change in 8% of cases. For open surgery, radiculopathy resolved in 48%, improved in 40%, and remained unchanged in 12%. For neck pain, the MEF results were 40% resolved, 47% improved, and 13% unchanged. Open results for neck pain were 33% resolved, 56% improved, and 11% unchanged. Overall, there was no significant difference in outcomes between the groups. CONCLUSION: The MEF technique yielded clinical results equivalent to those of the open surgical group as well as to those described in the literature. MEF patients, however, had less blood loss, shorter hospitalizations, and a much lower postoperative pain medication requirement.
|
https://pubmed.ncbi.nlm.nih.gov/12234428/
|
[
"Clinical Trial",
"Journal Article"
] |
12234428
|
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] |
12,234,440 |
Microendoscopic lumbar discectomy: technical note.
|
Perez-Cruet Mick J MJ, Foley Kevin T KT, Isaacs Robert E RE, Rice-Wyllie Lauri L, Wellington Robin R, Smith Maurice M MM, Fessler Richard G RG
|
Neurosurgery . Vol. 51, No. 5 Suppl, 2002 Nov
|
OBJECTIVE: The microendoscopic discectomy (MED) technique was initially developed in 1997 to treat herniated lumbar disc disease. Since then, thousands of cases have been successfully performed at more than 500 institutions. This article discusses the technical aspects of this procedure and presents a consecutive case series. METHODS: A total of 150 consecutive patients underwent MED. MED is performed by a muscle-splitting approach using a series of tubular dilators with consecutively increasing diameters. A tubular retractor is then inserted over the final dilator, and a specially designed endoscope is placed inside the tubular retractor. The microdiscectomy is performed endoscopically while the surgeon views the procedure on a video monitor. RESULTS: Clinical outcomes were determined using a modified MacNab criteria, which revealed that 77% of patients had excellent, 17% had good, 3% had fair, and 3% had poor outcomes. The average hospital stay was 7.7 hours. The average return to work period was 17 days. Complications primarily included dural tears, which occurred in 8 patients (5%) and were seen early on in the patient series. Complication rates diminished as the surgeon's experience with this technique increased. CONCLUSION: MED for lumbar herniated disc disease can be performed safely and effectively, resulting in a shortened hospital stay and faster return to work; however, there is a learning curve to this procedure.
|
https://pubmed.ncbi.nlm.nih.gov/12234440/
|
[
"Clinical Trial",
"Journal Article"
] |
12234440
|
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] |
12,234,503 |
A randomised comparison of bicalutamide ('Casodex') 150 mg versus placebo as immediate therapy either alone or as adjuvant to standard care for early non-metastatic prostate cancer. First report from the Scandinavian Prostatic Cancer Group Study No. 6.
|
Iversen P P, Tammela T L J TL, Vaage S S, Lukkarinen O O, Lodding P P, Bull-Njaa T T, Viitanen J J, Hoisaeter P P, Lundmo P P, Rasmussen F F, Johansson J-E JE, Persson B-E BE, Carroll K K,
|
European urology . Vol. 42, No. 3, 2002 Sep
|
OBJECTIVES: To assess the efficacy and tolerability of bicalutamide 150 mg ('Casodex'(1)) as immediate therapy, either alone or as adjuvant to treatment of curative intent, in patients with early (T1b-T4, any N, M0) prostate cancer. METHODS: This randomised, double-blind study was conducted in the Nordic countries as part of the 'Casodex' Early Prostate Cancer programme. Patients received bicalutamide 150 mg (n=607) or placebo (n=611) in addition to standard care. RESULTS: More than 80% of patients had not received therapy of primary curative intent. Median follow-up in both groups was 3 years. Median exposure to study treatment in the bicalutamide and standard care alone groups was 2.5 and 2.3 years, respectively. Bicalutamide reduced the risk of objective disease progression by 57% compared with standard care alone (HR 0.43; 95% CI 0.34, 0.55; p<<0.0001). Survival data were immature (11.4% deaths) with no difference between the two treatment groups. CONCLUSIONS: Bicalutamide 150 mg as immediate therapy, either alone or as adjuvant to treatment of curative intent, significantly reduces the risk of disease progression in patients with early prostate cancer. The trial is ongoing to assess whether the reduction in risk of objective progression translates into an overall survival benefit.
|
https://pubmed.ncbi.nlm.nih.gov/12234503/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12234503
|
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] |
12,234,505 |
Lack of effect of intrarectal lidocaine for pain control during transrectal prostate biopsy: a randomized prospective study.
|
Cevik Ibrahim I, Ozveri Hakan H, Dillioglugil Ozdal O, Akdaş Atif A
|
European urology . Vol. 42, No. 3, 2002 Sep
|
INTRODUCTION AND OBJECTIVES: Transrectal ultrasound guided biopsy is an essential part in the diagnosis of prostate cancer. Although this procedure is well tolerated by most patients, sometimes it can result in some uneasiness. In this randomised double-blind placebo controlled study, we evaluated the effectiveness of intrarectal lidocaine during TRUS guided biopsy. MATERIALS AND METHODS: 100 consecutive eligible patients who had elevated total prostate specific antigen (tPSA) and/or abnormal digital rectal examination (DRE) were included into this study. Patients were randomised into two groups. Group I received 20 cc of 2% intrarectal lidocaine 20 minutes before transrectal ultrasound guided biopsy and Group II received same amount of serum physiologic. Pain was assessed using a 10 point modified visual analog scale. RESULTS: Mean patient age was 65.5+/-2.5 and 64.5+/-11.5 years, mean tPSA was 12.3+/-3.6 and 11.3+/-1.7 ng/ml, mean biopsy duration was 6.8+/-2.5 and 6.6+/-2.2 minutes, mean pain score during transrectal ultrasound guided biopsy was 4.8+/-2.2 and 4.4+/-2.1 in Groups I and II, respectively. No statistically significant difference was observed with respect to age, tPSA, mean biopsy duration and pain score between these groups. There was only one patient who could not tolerate the procedure at all, and he was paradoxically in the lidocaine group. CONCLUSION: The use of intrarectal lidocaine is not superior to placebo during transrectal prostate biopsy for pain control.
|
https://pubmed.ncbi.nlm.nih.gov/12234505/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12234505
|
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] |
12,234,565 |
Preventing thromboembolic complications in cancer patients after surgery: a role for prolonged thromboprophylaxis.
|
Rasmussen Morten S MS
|
Cancer treatment reviews . Vol. 28, No. 3, 2002 Jun
|
Patients undergoing major abdominal surgery for malignancy are at particularly high risk of developing VTE. Extra protection against this can be given to patients with cancer by using a higher dose of LMWH than normally used for prophylaxis, with no increase in bleeding complications. Despite thromboprophylaxis with high-dose LMWH for the first postoperative week, the rate of late VTE is estimated to be between 10% and 20%. A meta-analysis of two studies using dalteparin or enoxaparin has shown that prolonging thromboprophylaxis for a further 3 weeks significantly reduces the risk of late occurring VTE by 62%. Thromboprophylaxis with LMWH for at least one month should be considered in patients undergoing surgery for malignant disease.
|
https://pubmed.ncbi.nlm.nih.gov/12234565/
|
[
"Journal Article",
"Meta-Analysis",
"Review"
] |
12234565
|
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] |
12,234,697 |
Remediastinoscopy after neoadjuvant therapy for non-small cell lung cancer.
|
Van Schil P P, van der Schoot J J, Poniewierski J J, Pauwels M M, Carp L L, Germonpré P P, De Backer W W
|
Lung cancer (Amsterdam, Netherlands) . Vol. 37, No. 3, 2002 Sep
|
Despite technical difficulties due to mediastinal fibrosis, remediastinoscopy can be a valuable tool in the restaging of non-small cell lung cancer after neoadjuvant therapy. The aim of our study was to evaluate the feasibility, sensitivity and accuracy of remediastinoscopy. From November 1994 to July 2001 we performed a remediastinoscopy in 27 patients after neoadjuvant therapy. Their age ranged from 35 to 80 years (mean 61.9+/-11.9). In all 27 patients it was possible to perform a remediastinoscopy without major technical difficulties and take biopsies of the lymph nodes that were initially invaded by tumour. Remediastinoscopy was positive in 11 patients (40.7%) and negative in 16 (59.3%). In the 11 patients with a positive remediastinoscopy a complete resection was not judged possible and therefore, an unnecessary thoracotomy was avoided. In four patients, remediastinoscopy turned out to be false negative. So, in our series, sensitivity was 73%, specificity 100% and accuracy 85%. The positive and negative predictive values were 100 and 75%, respectively. Previous mediastinoscopy is no contra-indication for a repeat one after neoadjuvant therapy. Although sensitivity and accuracy are lower than that of a first mediastinoscopy, remediastinoscopy is useful to select patients for surgical resection after induction therapy.
|
https://pubmed.ncbi.nlm.nih.gov/12234697/
|
[
"Clinical Trial",
"Journal Article"
] |
12234697
|
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0.1511222869157791,
0.00808824971318245,
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-0.1046462208032608,
0.11251223832368851,
-0.018033774569630623,
0.013976825401186943,
-0.255349725484848,
0.40441015362739563,
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0.336574524641037,
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0.47497692704200745,
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0.11864550411701202,
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0.12132258713245392,
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0.2967992424964905,
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0.07807381451129913,
0.06534384936094284
] |
12,234,700 |
The influence of gender on survival and tumor recurrence following adjuvant therapy of completely resected stages II and IIIa non-small cell lung cancer.
|
Keller S M SM, Vangel M G MG, Adak S S, Wagner H H, Schiller J H JH, Herskovic A A, Komaki R R, Perry M C MC, Marks R S RS, Livingston R B RB, Johnson D H DH
|
Lung cancer (Amsterdam, Netherlands) . Vol. 37, No. 3, 2002 Sep
|
This study evaluates the influence of gender on survival and tumor recurrence following adjuvant therapy of completely resected stages II and IIIa non-small cell lung cancer (NSCLC). The Eastern Cooperative Oncology Group conducted a randomized prospective trial of adjuvant therapy in patients with completely resected stages II and IIIa NSCLC. A laboratory correlative study assessed the prevalence and prognostic significance of p53 and K-ras mutations. Patients were randomized to receive either radiotherapy (RT) alone or four cycles of cisplatin and VP-16 administered concurrently with radiotherapy (CRT). Median survival was 35 months for the 285 men and 41 months for the 203 women enrolled in the study (P = 0.12). The relative risk (RR) of death for men vs women was 1.19 (95% confidence interval [CI], 0.95-1.49). Median survival of the 147 men and 95 women randomized to the RT arm was 39 months each (P = 0.35). Median survival of the 138 men and 108 women randomized to the CRT arm was 30 and 42 months, respectively (P = 0.18). Disease recurrence patterns were similar between the genders. Univariate and multivariate analyses demonstrated improved survival for women with tumors of non-squamous histology (P < 0.01). The distribution of p53 and K-ras mutations was similar between the genders and had no influence on survival. Gender does not influence survival following adjuvant RT or CRT administered to patients with completely resected stages II and IIIa NSCLC. However, women with non-squamous histology have increased survival when compared to men.
|
https://pubmed.ncbi.nlm.nih.gov/12234700/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, U.S. Gov't, P.H.S."
] |
12234700
|
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] |
12,234,702 |
Phase II study of weekly irinotecan and carboplatin for refractory or relapsed small-cell lung cancer.
|
Naka Nobuyuki N, Kawahara Masaaki M, Okishio Kyoichi K, Hosoe Shigeto S, Ogawara Mitsumasa M, Atagi Shinji S, Takemoto Yuuji Y, Ueno Kiyonobu K, Kawaguchi Tomoya T, Tsuchiyama Tessei T, Furuse Kiyoyuki K
|
Lung cancer (Amsterdam, Netherlands) . Vol. 37, No. 3, 2002 Sep
|
We designed a phase II study of weekly irinotecan (CPT-11) and carboplatin for refractory or relapsed small cell lung cancer (SCLC) and assessed the response rate, survival, and toxicity. Twenty-nine patients with refractory or relapsed SCLC were entered onto the trial. The median time off chemotherapy was 3.5 months (range: 0.8-12.9). Patients were treated at 4-week intervals using CPT-11 (50 mg/m(2) intravenously on days 1, 8 and 15) plus carboplatin (AUC = 2 mg/ml min, intravenously on days 1, 8, 15). All patients were assessable for toxicity and survival; 28 patients were assessable for response. There were nine partial responses (PRs). Overall response rate was 31.0% (95% CI: 15.3-50.8%). The median time to progression was 3.5 months. Median survival time was 6.1 months. Major toxicity was myelosuppression. Grade 3 to 4 neutropenia and thrombocytopenia occurred in 52 and 21% of patients, respectively. Grade 3-4 diarrhea was observed in 7%. There was one treatment-related death due to febrile neutropenia and sepsis. This combination of CPT-11 and carboplatin seems to be active second-line regimen with acceptable toxicity against small cell lung cancer.
|
https://pubmed.ncbi.nlm.nih.gov/12234702/
|
[
"Clinical Trial",
"Clinical Trial, Phase II",
"Journal Article"
] |
12234702
|
[
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] |
12,234,701 |
Study of either ifosfamide or teniposide compared to a standard chemotherapy for extensive disease small cell lung cancer: an Eastern Cooperative Oncology Group randomized study (E1588).
|
Ettinger David S DS, Finkelstein Dianne M DM, Ritch Paul S PS, Lincoln Sarah T ST, Blum Ronald H RH,
|
Lung cancer (Amsterdam, Netherlands) . Vol. 37, No. 3, 2002 Sep
|
This randomized study of previously untreated patients with extensive disease small cell lung cancer was designed (a) to compare the survival of patients treated with either effective standard chemotherapy or an investigational anti-cancer drug as initial therapy and (b) to evaluate response rates and toxic effects of such therapies. One hundred and thirty-five patients were randomly assigned to receive as initial therapy, either the standard CAV regimen--cyclophosphamide (1000 mg/m(2)), doxorubicin (50 mg/m(2)) and vincristine (1.4 mg/m(2)) every 3 weeks--or the phase II drugs ifosfamide (1.5 gm/m(2)/days 1-5) with mesna (300 mg/m(2)) dose at 0, 4 and 8 h after IV daily ifosfamide every 3 weeks or teniposide (60 mg/m(2)/days 1-5) every 3 weeks. Nonresponders received salvage chemotherapy-etoposide (120 mg/m(2) on days 1, 2 and 3) and cisplatin (60 mg/m(2) on day 1), repeated every 3 weeks. Among the 46 patients on CAV, there were two complete and 24 partial responses (56%). Among the 43 patients on ifosfamide, there were three complete and 18 partial responses (49%), while among the 46 patients on teniposide, there were two complete and 18 partial responses (43%). Eighty-three of the patients proceeded onto salvage regimen, of which 81 were analyzable for response and toxicity. Among the 81 patients who continued on salvage therapy and were evaluable for response, the overall best response rate was 61% for CAV+salvage, 54% for ifosfamide+salvage, and 53% for teniposide+salvage. These rates were not significantly different (P=0.962). Of the 135 analyzable patients, 130 (96%) have died. The estimated median survival time was 42 weeks for CAV patients, 43 weeks for ifosfamide, and 38 weeks for teniposide. Seven patients survived longer than 2 years (four on CAV, one on ifosfamide and two on teniposide). There were 29 life-threatening complications to the induction regimen (22 (48%) on CAV, four (9%) on ifosfamide and three (7%) on teniposide) and seven lethal complications (two on CAV, four on ifosfamide and one on teniposide). The treatments were significantly different with respect to the overall degree of toxicity (P < 0.0001) with CAV being more toxic. The data of this study, like the previous ECOG study suggests that the administration of a new agent followed by effective salvage chemotherapy in the treatment of extensive disease small cell lung cancer may have no adverse effect on survival.
|
https://pubmed.ncbi.nlm.nih.gov/12234701/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Multicenter Study",
"Randomized Controlled Trial",
"Research Support, U.S. Gov't, P.H.S."
] |
12234701
|
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] |
12,234,785 |
Effect of cardiac pacing on forearm vascular responses and nitric oxide function.
|
Green Daniel D, Cheetham Craig C, Henderson Chelsea C, Weerasooriya Rukshen R, O'Driscoll Gerard G
|
American journal of physiology. Heart and circulatory physiology . Vol. 283, No. 4, 2002 Oct
|
We examined the hypothesis that changes in heart rate at rest influence bioactivity of nitric oxide (NO) in humans by examining forearm blood flow responses during cardiac pacing in six subjects. Peak forearm and mean forearm blood flows across the cardiac cycle were continuously recorded at baseline and during pacing, with the use of high-resolution brachial artery ultrasound and Doppler flow velocity measurement. The brachial artery was cannulated to allow continuous infusion of saline or N(G)-monomethyl-L-arginine (L-NMMA). As heart rate increased, no changes in pulse pressure and mean or peak blood flow were evident. L-NMMA had no effect on brachial artery diameter, velocity, or flows compared with saline infusion. These results contrast with our recent findings that exercise involving the lower body, associated with increases in heart rate and pulse pressure, also increased forearm blood flow, the latter response being diminished by L-NMMA. These data suggest that changes in blood pressure, rather than pulse frequency, may be the stimulus for shear stress-mediated NO release in vivo.
|
https://pubmed.ncbi.nlm.nih.gov/12234785/
|
[
"Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12234785
|
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] |
12,234,793 |
Angiotensin II contributes to arterial compliance in congestive heart failure.
|
Lage Silvia G SG, Kopel Liliane L, Medeiros Caio C J CC, Carvalho Ricardo T RT, Creager Mark A MA
|
American journal of physiology. Heart and circulatory physiology . Vol. 283, No. 4, 2002 Oct
|
Arterial compliance is determined by structural factors, such as collagen and elastin, and functional factors, such as vasoactive neurohormones. To determine whether angiotensin II contributes to decreased arterial compliance in patients with heart failure, this study tested the hypothesis that administration of an angiotensin-converting enzyme inhibitor improves arterial compliance. Arterial compliance and stiffness were determined by measuring carotid artery diameter, using high-resolution duplex ultrasonography, and blood pressure in 23 patients with heart failure secondary to idiopathic dilated cardiomyopathy. Measurements were made before and after intravenous administration of enalaprilat (1 mg) or vehicle. Arterial compliance was inversely related to both baseline plasma angiotensin II (r = -0.52; P = 0.015) and angiotensin-converting enzyme concentrations (r = -0.45; P = 0.041). During isobaric conditions, enalaprilat increased carotid artery compliance from 3.0 +/- 0.4 to 5.0 +/- 0.4 x 10(-10) N(-1). m(4) (P = 0.001) and decreased the carotid artery stiffness index from 17.5 +/- 1.8 to 10.1 +/- 0.6 units (P = 0.001), whereas the vehicle had no effect. Thus angiotensin II is associated with reduced carotid arterial compliance in patients with congestive heart failure, and angiotensin-converting enzyme inhibition improves arterial elastic properties. This favorable effect on the pulsatile component of afterload may contribute to the improvement in left ventricular performance that occurs in patients with heart failure treated with angiotensin-converting enzyme inhibitors.
|
https://pubmed.ncbi.nlm.nih.gov/12234793/
|
[
"Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12234793
|
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] |
12,234,815 |
Transmural gradients of cardiac myofiber shortening in aortic valve stenosis patients using MRI tagging.
|
Van Der Toorn A A, Barenbrug P P, Snoep G G, Van Der Veen F H FH, Delhaas T T, Prinzen F W FW, Maessen J J, Arts T T
|
American journal of physiology. Heart and circulatory physiology . Vol. 283, No. 4, 2002 Oct
|
Aortic valve stenosis impairs subendocardial perfusion with a risk of irreversible subendocardial tissue damage. A likely precursor of damage is subendocardial contractile dysfunction, expressed by the parameter TransDif, which is defined as epicardial minus endocardial myofiber shortening, normalized to the mean value. With the use of magnetic resonance tagging in two short-axis slices of the left ventricle (LV), TransDif was derived from LV torsion and contraction during ejection. TransDif was determined in healthy volunteers (control, n = 9) and in patients with aortic valve stenosis before (AVSten, n = 9) and 3 mo after valve replacement (AVRepl, n = 7). In the control group, TransDif was 0.00 +/- 0.14 (mean +/- SD). In the AVSten group, TransDif increased to 0.96 +/- 0.62, suggesting impairment of subendocardial myofiber shortening. In the AVRepl group, TransDif decreased to 0.37 +/- 0.20 but was still elevated. In eight of nine AVSten patients, the TransDif value was elevated individually (P < 0.001), suggesting that the noninvasively determined parameter TransDif may provide important information in planning of treatment of aortic valve stenosis.
|
https://pubmed.ncbi.nlm.nih.gov/12234815/
|
[
"Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12234815
|
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] |
12,234,851 |
Imiquimod 5-percent cream does not alter the natural history of recurrent herpes genitalis: a phase II, randomized, double-blind, placebo-controlled study.
|
Schacker Timothy W TW, Conant Marcus M, Thoming Christopher C, Stanczak Tamara T, Wang Zengri Z, Smith Michael M
|
Antimicrobial agents and chemotherapy . Vol. 46, No. 10, 2002 Oct
|
Present strategies for control of herpes genitalis recurrences require multiple daily doses of antiviral medication. Imiquimod, an immune response modifier, induces alpha interferon and interleukin-12; application in the presence of local herpes antigens during a recurrence may augment herpes simplex virus (HSV)-specific cell-mediated immunity. To test this theory, we performed a randomized, double-blind, placebo-controlled study of imiquimod 5% cream to assess safety and efficacy for decreasing recurrences. Patients with six or more recurrences of herpes genitalis per year applied study cream (imiquimod or placebo) to lesions one, two, or three times per week for 3 weeks for each recurrence during a 16-week treatment period. This was followed by a 16-week observation period. Of 124 patients randomized to the study, 103 completed the treatment period and 93 completed the observation period. The median times to first genital herpes recurrence were 53 days for those receiving placebo (n = 30) and 54, 60, and 64 days for those receiving imiquimod one time per week (n = 34), two times per week (n = 32), and three times per week (n = 28), respectively. The median annualized recurrence rates during the treatment period were 3.8, 4.9, 3.2, and 3.1, respectively. There were no statistically significant differences in the time to first recurrence or in the annualized recurrence rate between the imiquimod and placebo groups in either the treatment or the observation period. A trend in increased rates of local adverse events at the application site and a delay in lesion healing with more frequent dosing suggested a pharmacologic effect. Although clinical efficacy has been observed for imiquimod in other conditions in which a TH1-type immune response may be beneficial, including other viral infections such as those caused by human papillomavirus, no apparent effect on the short-term natural history of herpes genitalis recurrences was observed.
|
https://pubmed.ncbi.nlm.nih.gov/12234851/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12234851
|
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12,234,860 |
Use of fluoroquinolones in patients with chronic hepatitis C virus-induced liver failure.
|
Kojima H H, Kaita K D E KD, Hawkins K K, Uhanova J J, Minuk G Y GY
|
Antimicrobial agents and chemotherapy . Vol. 46, No. 10, 2002 Oct
|
Fluroquinolone antibiotics have been reported to have antiviral properties against RNA viruses, including hepatitis C virus (HCV). In the present study, five patients with advanced liver disease secondary to chronic HCV received 500 mg daily of oral ciprofloxacin for 30 days. Serum HCV-RNA levels and liver enzyme abnormalities remained largely unchanged. Thus, the role of fluoroquinolones as antiviral agents for chronic HCV in patients with advanced liver disease appears to be limited.
|
https://pubmed.ncbi.nlm.nih.gov/12234860/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12234860
|
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] |
12,234,887 |
Entonox as an analgesic agent during panretinal photocoagulation.
|
Cook H L HL, Newsom R S B RS, Mensah E E, Saeed M M, James D D, Ffytche T J TJ
|
The British journal of ophthalmology . Vol. 86, No. 10, 2002 Oct
|
BACKGROUND/AIMS: Panretinal photocoagulation (PRP) reduces the risk of visual loss in proliferative diabetic retinopathy but some patients cannot tolerate PRP because of pain. Inhaled Entonox was evaluated as an analgesic during PRP. METHODS: A randomised, crossover, double masked pilot study was performed. Patients inhaled either air or Entonox and half the PRP was applied. The treatment was completed with the alternate inhaled gas. Patients graded pain experienced during both stages of the treatment using a visual analogue scale. Pain scores were compared using a paired t test. RESULTS: 20 patients participated. Mean pain scores from the Entonox and air treatments were 2.94 (SD 2.73) versus 3.73 (SD 3.20) respectively (p<0.03). CONCLUSION: Entonox can be used as a safe and effective analgesic agent during PRP treatment.
|
https://pubmed.ncbi.nlm.nih.gov/12234887/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12234887
|
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] |
12,234,889 |
Lyophilisates for drug delivery in ophthalmology: pharmacokinetics of fluorescein in the human anterior segment.
|
Dinslage S S, Diestelhorst M M, Weichselbaum A A, Süverkrüp R R
|
The British journal of ophthalmology . Vol. 86, No. 10, 2002 Oct
|
AIMS: To assess the ocular bioavailability of fluorescein from a novel water free, freeze dried ophthalmic drug delivery system compared to conventional preservative-free fluorescein eye drops. METHODS: Sodium fluorescein 0.17% was dissolved in an aqueous solution of hydroxypropylmethyl cellulose 1.0% (HPMC), deposited on sterilised flexible hydrophobic poly(tetrafluoroethylene) (PTFE) carrier strips and freeze dried under aseptic conditions. The fluorescein dose of the lyophilisate was 68 micro g, corresponding to a single conventional drop of 40 micro l fluorescein 0.17% solution. In a randomised, open label study 12 healthy volunteers applied the lyophilised fluorescein to one eye and one drop of conventional fluorescein ophthalmic solution to the fellow eye. Fluorophotometry measurements of fluorescein concentrations in the anterior segment were performed with the Fluorotron Master II (Ocumetrics, USA) before and +15, 30, 45, 60, 120, and 180 minutes after application. RESULTS: At all times anterior chamber fluorescein concentration was greater in the lyophysilate treated eye than the solution treated eye. The magnitude of this difference ranged from 2-5.3 times and was statistically significant. CONCLUSION: The greater intraocular bioavailability of fluorescein from the lyophilisate relative to the solution suggests that it may be a useful method for delivering substances to the eye.
|
https://pubmed.ncbi.nlm.nih.gov/12234889/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12234889
|
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] |
12,234,896 |
Effect of inhalation of different mixtures of O(2) and CO(2) on retinal blood flow.
|
Luksch A A, Garhöfer G G, Imhof A A, Polak K K, Polska E E, Dorner G T GT, Anzenhofer S S, Wolzt M M, Schmetterer L L
|
The British journal of ophthalmology . Vol. 86, No. 10, 2002 Oct
|
AIM: To determine the effects of various mixtures of O(2) and CO(2) on retinal blood flow in healthy subjects. METHODS: A randomised, double masked, four way crossover trial was carried out in 12 healthy male non-smoking subjects. Gas mixtures (100% O(2), 97.5% O(2) + 2.5% CO(2), 95% O(2) + 5% CO(2), and 92% O(2) + 8% CO(2)) were administered for 10 minutes each. Two non-invasive methods were used: laser Doppler velocimetry (LDV) for measurement of retinal blood velocity and fundus imaging with the Zeiss retinal vessel analyser (RVA) for the assessment of retinal vessel diameters. Arterial pH, pCO(2), and pO(2) were determined with an automatic blood gas analysis system. Retinal blood flow through a major temporal vein was calculated. RESULTS: Retinal blood velocity, retinal vessel diameter, and retinal blood flow decreased during all breathing periods (p <0.001 each). Administration of 92% O(2) + 8% CO(2) significantly increased SBP, MAP, and PR (p <0.001 each, versus baseline), whereas the other gas mixtures had little effect on systemic haemodynamics. Addition of 2.5%, 5%, and 8% CO(2) to oxygen caused a marked decrease in pH and an increase in pCO(2) (p <0.001 versus pure oxygen). CONCLUSIONS: Breathing of pure oxygen and oxygen in combination with carbon dioxide significantly decreases retinal blood flow. Based on these data the authors speculate that hyperoxia induced vasoconstriction is not due to changes in intravascular pH and cannot be counteracted by an intravascular increase in pCO(2).
|
https://pubmed.ncbi.nlm.nih.gov/12234896/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12234896
|
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0.03940316662192345,
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0.2643932104110718,
0.08936937153339386,
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] |
12,234,946 |
Simvastatin lowers C-reactive protein within 14 days: an effect independent of low-density lipoprotein cholesterol reduction.
|
Plenge Julie K JK, Hernandez Teri L TL, Weil Kathleen M KM, Poirier Paul P, Grunwald Gary K GK, Marcovina Santica M SM, Eckel Robert H RH
|
Circulation . Vol. 106, No. 12, 2002 Sep 17
|
BACKGROUND: The early response of C-reactive protein to initiation of a hydroxymethylglutaryl coenzyme A reductase inhibitor (statin) is not known. The purpose of this study was to determine the rate at which highly sensitive C-reactive protein (hsCRP) levels change after initiation of simvastatin and whether this occurs independently of the change in LDL cholesterol. METHODS AND RESULTS: The study was a crossover, double-blind design including 40 subjects with elevated LDL cholesterol. Subjects were randomly assigned to 1 of 2 groups: simvastatin 40 mg for 14 days, then placebo for 14 days, or placebo first, then simvastatin. Simvastatin decreased LDL cholesterol by 56+/-4 mg/dL (P<0.0001) at day 7 and by an additional 8+/-3 mg/dL (P=0.02) at day 14. Baseline log(hsCRP) levels were similar in the 2 groups. By day 14, log(hsCRP) was significantly lower in patients on simvastatin when compared with placebo (P=0.011). Although there was no significant difference in fibrinogen levels, simvastatin produced a modest increase in log[lipoprotein(a)] (P=0.03) at days 7 and 14. There were no relationships between the decrease in LDL cholesterol and the decrease in hsCRP. CONCLUSIONS: Simvastatin lowers hsCRP by 14 days, independent of its effect on LDL cholesterol. This rapid impact of a statin on hsCRP has potential implications in the management of acute coronary syndromes.
|
https://pubmed.ncbi.nlm.nih.gov/12234946/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, P.H.S."
] |
12234946
|
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12,234,947 |
Alpha-tocopherol supplementation in healthy individuals reduces low-density lipoprotein oxidation but not atherosclerosis: the Vitamin E Atherosclerosis Prevention Study (VEAPS).
|
Hodis Howard N HN, Mack Wendy J WJ, LaBree Laurie L, Mahrer Peter R PR, Sevanian Alex A, Liu Chao-ran CR, Liu Ci-hua CH, Hwang Juliana J, Selzer Robert H RH, Azen Stanley P SP,
|
Circulation . Vol. 106, No. 12, 2002 Sep 17
|
BACKGROUND: Epidemiological studies have demonstrated an inverse relationship between vitamin E intake and cardiovascular disease (CVD) risk. In contrast, randomized controlled trials have reported conflicting results as to whether vitamin E supplementation reduces atherosclerosis progression and CVD events. METHODS AND RESULTS: The study population consisted of men and women > or =40 years old with an LDL cholesterol level > or =3.37 mmol/L (130 mg/dL) and no clinical signs or symptoms of CVD. Eligible participants were randomized to DL-alpha-tocopherol 400 IU per day or placebo and followed every 3 months for an average of 3 years. The primary trial end point was the rate of change in the common carotid artery far-wall intima-media thickness (IMT) assessed by computer image-processed B-mode ultrasonograms. A mixed effects model using all determinations of IMT was used to test the hypothesis of treatment differences in IMT change rates. Compared with placebo, alpha-tocopherol supplementation significantly raised plasma vitamin E levels (P<0.0001), reduced circulating oxidized LDL (P=0.03), and reduced LDL oxidative susceptibility (P<0.01). However, vitamin E supplementation did not reduce the progression of IMT over a 3-year period compared with subjects randomized to placebo. CONCLUSIONS: The results are consistent with previous randomized controlled trials and extend the null results of vitamin E supplementation to the progression of IMT in healthy men and women at low risk for CVD.
|
https://pubmed.ncbi.nlm.nih.gov/12234947/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, P.H.S."
] |
12234947
|
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] |
12,234,948 |
High doses of vitamin C reverse Escherichia coli endotoxin-induced hyporeactivity to acetylcholine in the human forearm.
|
Pleiner Johannes J, Mittermayer Friedrich F, Schaller Georg G, MacAllister Raymond J RJ, Wolzt Michael M
|
Circulation . Vol. 106, No. 12, 2002 Sep 17
|
BACKGROUND: Acute inflammation causes endothelial vasodilator dysfunction that may be mediated by oxidative stress. METHODS AND RESULTS: In this randomized, double-blind, crossover study, forearm blood flow responses to acetylcholine (ACh) (endothelium-dependent dilator) and glyceryl-trinitrate (GTN) (endothelium-independent dilator) were assessed before and after induction of acute systemic inflammation by low doses of Escherichia coli endotoxin (LPS) (20 IU/kg IV) in 8 healthy volunteers. The acute effect of intra-arterial vitamin C (24 mg/min) or placebo was studied 4 hours after LPS, respectively. Vitamin C alone was administered in control experiments. LPS administration caused systemic vasodilation, increased white blood count, elevated body temperature, and reduced vitamin C plasma concentrations. LPS decreased the responses of forearm blood flow to ACh by 30% (P<0.05) but not to GTN. Vitamin C completely restored the response to ACh, which was comparable with that observed under baseline conditions. Vitamin C had no effect on basal blood flow or ACh- or GTN-induced vasodilation in control subjects. CONCLUSIONS: Our data demonstrate that impaired endothelial vasodilation caused by E coli endotoxemia can be counteracted by high doses of antioxidants in vivo. Oxidative stress may play an important role in the pathogenesis of endothelial dysfunction during inflammation.
|
https://pubmed.ncbi.nlm.nih.gov/12234948/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12234948
|
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] |
12,234,951 |
Survival in primary pulmonary hypertension: the impact of epoprostenol therapy.
|
McLaughlin Vallerie V VV, Shillington Alicia A, Rich Stuart S
|
Circulation . Vol. 106, No. 12, 2002 Sep 17
|
BACKGROUND: Primary pulmonary hypertension (PPH) is a severe and progressive disease. Without treatment, the median survival is 2.8 years, with survival rates of 68%, 48%, and 34% at 1, 3, and 5 years, respectively. Intravenous epoprostenol was the first Food and Drug Administration-approved therapy for PPH. The long-term impact that epoprostenol has made on PPH remains to be defined. METHODS AND RESULTS: One hundred sixty-two consecutive patients diagnosed with PPH and treated with epoprostenol were followed for a mean of 36.3 months (median, 31 months). Data including functional class, exercise tolerance, and hemodynamics were recorded in a customized database. Vital status was verified in each patient. Observed survival with epoprostenol therapy at 1, 2, and 3 years was 87.8%, 76.3%, and 62.8% and was significantly greater than the expected survival of 58.9%, 46.3%, and 35.4% based on historical data. Baseline predictors of survival included exercise tolerance, functional class, right atrial pressure, and vasodilator response to adenosine. Predictors of survival after the first year of therapy included functional class and improvement in exercise tolerance, cardiac index, and mean pulmonary artery pressure. CONCLUSIONS: Intravenous epoprostenol improves long-term survival in PPH.
|
https://pubmed.ncbi.nlm.nih.gov/12234951/
|
[
"Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12234951
|
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12,234,950 |
Randomized COMparison of platelet inhibition with abciximab, tiRofiban and eptifibatide during percutaneous coronary intervention in acute coronary syndromes: the COMPARE trial. Comparison Of Measurements of Platelet aggregation with Aggrastat, Reopro, and Eptifibatide.
|
Batchelor Wayne B WB, Tolleson Thaddeus R TR, Huang Yao Y, Larsen Rhonda L RL, Mantell R Michael RM, Dillard Patricia P, Davidian Marie M, Zhang Daowen D, Cantor Warren J WJ, Sketch Michael H MH, Ohman E Magnus EM, Zidar James P JP, Gretler Daniel D, DiBattiste Peter M PM, Tcheng James E JE, Califf Robert M RM, Harrington Robert A RA
|
Circulation . Vol. 106, No. 12, 2002 Sep 17
|
BACKGROUND: The relative anti-aggregatory effects of currently prescribed platelet glycoprotein IIb/IIIa receptor antagonists during and after percutaneous coronary intervention for acute coronary syndromes have not been established. METHODS AND RESULTS: We randomized 70 acute coronary syndrome patients undergoing percutaneous coronary intervention to receive abciximab, eptifibatide, or tirofiban at doses used in the Evaluation of Platelet IIb/IIIa Inhibitor for STENTing (EPISTENT), Platelet glycoprotein IIb/IIIa in Unstable angina Receptor Suppression Using Integrilin Therapy (PURSUIT), and Platelet Receptor Inhibition in ischemic Syndrome Management in Patients Limited by Unstable Signs and symptoms (PRISM-PLUS)/Randomized Efficacy Study of Tirofiban for Outcomes and Restenosis (RESTORE) trials, respectively. Platelet aggregation (PA) in response to 20 micro mol/L of adenosine diphosphate was measured with turbidimetric aggregometry in both D-phenylalanyl-L-prolyl-L-arginine chloromethylketone and citrate-anticoagulated blood early (15 and 30 minutes) and late (4, 12, and 18 to 24 hours) after drug initiation. At 15 and 30 minutes, PA was significantly less inhibited by the tirofiban-RESTORE regimen compared with abciximab (P=0.028) and eptifibatide regimens (P=0.0001). The abciximab regimen, however, showed increasingly varied anti-aggregatory effects during continued infusion for > or =4 hours. Citrate exaggerated ex vivo platelet inhibition after eptifibatide and tirofiban, but had the opposite effect on abciximab. Of all regimens evaluated, the eptifibatide regimen inhibited PA most consistently throughout both the early and late periods. CONCLUSIONS: Currently recommended drug regimens to inhibit the platelet glycoprotein IIb/IIIa receptor have distinct pharmacodynamic profiles that might affect their relative efficacy in acute coronary syndromes and percutaneous coronary intervention.
|
https://pubmed.ncbi.nlm.nih.gov/12234950/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12234950
|
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12,234,955 |
Serotonin reuptake inhibitor (Paxil) does not prevent the vasovagal reaction associated with carotid sinus massage and/or lower body negative pressure in healthy volunteers.
|
Takata Theodore S TS, Wasmund Stephen L SL, Smith Michael L ML, Li Jian-Ming JM, Joglar Jose A JA, Banks Kim K, Kowal Robert C RC, Page Richard L RL, Hamdan Mohamed H MH
|
Circulation . Vol. 106, No. 12, 2002 Sep 17
|
BACKGROUND: The purpose of this study was to assess the effect of the serotonin reuptake inhibitor paroxetine hydrochloride (Paxil, SmithKline Beecham) on cardiovascular reflexes. We hypothesized that Paxil prevents neurally mediated syncope (NMS) by attenuating the sympathoinhibition and vagotonia associated with a vasovagal reaction. METHODS AND RESULTS: In a double-blind randomized study, 25 healthy subjects with a positive response to either carotid sinus massage (CSM) or lower body negative pressure (LBNP) received Paxil (20 mg/d) or placebo for 6 weeks. Arterial baroreflex sensitivity (BRS), muscle sympathetic nerve activity (SNA), baroreflex control of SNA, blood pressure, and heart rate responses to CSM and LBNP were measured at baseline and at 6 weeks. Nineteen subjects completed the study (Paxil, n=9; placebo, n=10). In the Paxil group, BRS decreased significantly compared with baseline (15.8+/-4.0 ms/mm Hg versus 11.0+/-2.6 ms/mm Hg, P=0.05); however, all 9 subjects continued to have a positive response to LBNP with presyncope. Paxil did not attenuate the sympathoinhibition or vagotonia associated with a positive LBNP response and had no significant effect on baroreflex control of SNA. In the control group, no significant change in BRS was noted compared with baseline. Seven out of 9 subjects who had a positive LBNP response at baseline had a repeat positive LBNP response, and the subject with a positive CSM at baseline had a negative response at 6 weeks. CONCLUSIONS: Paxil decreases arterial BRS but does not prevent the presyncope associated with LBNP. The effect of Paxil on the autonomic reflexes in patients with neurally mediated syncope remains unclear.
|
https://pubmed.ncbi.nlm.nih.gov/12234955/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, U.S. Gov't, P.H.S."
] |
12234955
|
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] |
12,234,956 |
Sirolimus-eluting stents for the treatment of obstructive superficial femoral artery disease: six-month results.
|
Duda Stephan H SH, Pusich Benjamin B, Richter Goetz G, Landwehr Peter P, Oliva Vincent L VL, Tielbeek Alexander A, Wiesinger Benjamin B, Hak Jan Bart JB, Tielemans Hans H, Ziemer Gerhard G, Cristea Ecatarina E, Lansky Alexandra A, Bérégi Jean P JP
|
Circulation . Vol. 106, No. 12, 2002 Sep 17
|
BACKGROUND: Stent implantation for obstructive femoropopliteal artery disease has been associated with poor long-term outcomes. This study evaluated the effectiveness of shape memory alloy recoverable technology (SMART) nitinol self-expanding stents coated with a polymer impregnated with sirolimus (rapamycin) versus uncoated SMART stents in superficial femoral artery obstructions. METHODS AND RESULTS: Thirty-six patients were recruited for this double-blind, randomized, prospective trial. All patients had chronic limb ischemia and femoral artery occlusions (57%) or stenoses (average lesion length, 85+/-57 mm). Patients were eligible for randomization after successful guidewire passage across the lesion. Eighteen patients received sirolimus-eluting SMART stents and 18 patients received uncoated SMART stents. The primary end point of the study was the in-stent mean percent diameter stenosis, as measured by quantitative angiography at 6 months. The in-stent mean percent diameter stenosis was 22.6% in the sirolimus-eluting stent group versus 30.9% in the uncoated stent group (P=0.294). The in-stent mean lumen diameter was significantly larger in the sirolimus-eluting stent group (4.95 mm versus 4.31 mm in the uncoated stent group; P=0.047). No serious adverse events (death or prolonged hospitalization) were reported. CONCLUSIONS: The use of sirolimus-eluting SMART stents for superficial femoral artery occlusion is feasible, with a trend toward reducing late loss compared with uncoated stents. The coated stent also proved to be safe and was not associated with any serious adverse events.
|
https://pubmed.ncbi.nlm.nih.gov/12234956/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Multicenter Study",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12234956
|
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] |
12,234,957 |
More accurate quantification of pulmonary blood flow by magnetic resonance imaging than by lung perfusion scintigraphy in patients with fontan circulation.
|
Fratz Sohrab S, Hess John J, Schwaiger Markus M, Martinoff Stefan S, Stern Heiko C HC
|
Circulation . Vol. 106, No. 12, 2002 Sep 17
|
BACKGROUND: Quantitative evaluation of pulmonary perfusion using lung perfusion scintigraphy in patients with atriopulmonary anastomosis (APA) or total cavopulmonary connection (TCPC) or partial cavopulmonary connection (PCPC) is difficult because of preferential draining of the venae cavae to one lung. Scintigraphy is the gold standard. Phase-velocity MRI (PV-MRI) is a new technique for determining pulmonary perfusion. The aim of this study was therefore to determine whether PV-MRI is more accurate than scintigraphy for quantitative evaluation of pulmonary perfusion ratios in patients with APA, TCPC, or PCPC. METHODS AND RESULTS: We studied 15 patients with APA, TCPC, or PCPC (16+/-7 years old, 4 female). Twelve patients (15+/-8 years old, 3 female) with a single pulmonary blood source supplied by a subpulmonary ventricle, ensuring complete mixing of the radioactive tracer before entering the pulmonary circulation, served as controls. Pulmonary scintigraphy and PV-MRI were performed in all patients. Bland-Altman analysis showed a clinically unacceptable difference of 7.1% right pulmonary blood flow (27.2% upper and -13.0% lower limit of agreement) between the two methods in the study group. The two methods agreed excellently in the control group (difference, 1.6%; 4.0% upper and -7.2% lower limit of agreement), showing that the bad agreement in the study group was caused by the problems encountered using pulmonary scintigraphy in patients with APA, TCPC, or PCPC. CONCLUSIONS: Because of preferential caval flow into either lung, PV-MRI is more accurate for evaluating pulmonary perfusion ratios than lung perfusion scintigraphy in patients with Fontan-like circulation.
|
https://pubmed.ncbi.nlm.nih.gov/12234957/
|
[
"Case Reports",
"Clinical Trial",
"Comparative Study",
"Controlled Clinical Trial",
"Journal Article"
] |
12234957
|
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] |
12,235,019 |
Exercise endurance 1, 3, and 6 h after caffeine ingestion in caffeine users and nonusers.
|
Bell Douglas G DG, McLellan Tom M TM
|
Journal of applied physiology (Bethesda, Md. : 1985) . Vol. 93, No. 4, 2002 Oct
|
The purpose of the present study was to examine the duration of caffeine's ergogenic effect and whether it differs between users and nonusers of the drug. Twenty-one subjects (13 caffeine users and 8 nonusers) completed six randomized exercise rides to exhaustion at 80% of maximal oxygen consumption after ingesting either a placebo or 5 mg/kg of caffeine. Exercise to exhaustion was completed once per week at either 1, 3, or 6 h after placebo or drug ingestion. Exercise time to exhaustion differed between users and nonusers with the ergogenic effect being greater and lasting longer in nonusers. For the nonusers, exercise times 1, 3, and 6 h after caffeine ingestion were 32.7 +/- 8.4, 32.1 +/- 8.6, and 31.7 +/- 12.0 min, respectively, and these values were each significantly greater than the corresponding placebo values of 24.2 +/- 6.4, 25.8 +/- 9.0, and 23.2 +/- 7.1 min. For caffeine users, exercise times 1, 3, and 6 h after caffeine ingestion were 27.4 +/- 7.2, 28.1 +/- 7.8, and 24.5 +/- 7.6 min, respectively. Only exercise times 1 and 3 h after drug ingestion were significantly greater than the respective placebo trials of 23.3 +/- 6.5, 23.2 +/- 7.1, and 23.5 +/- 5.7 min. In conclusion, both the duration and magnitude of the ergogenic effect that followed a 5 mg/kg dose of caffeine were greater in the nonusers compared with the users.
|
https://pubmed.ncbi.nlm.nih.gov/12235019/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12235019
|
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] |
12,235,021 |
Cutaneous vascular function during acute hyperglycemia in healthy young adults.
|
Charkoudian N N, Vella A A, Reed A S AS, Minson C T CT, Shah P P, Rizza R A RA, Joyner M J MJ
|
Journal of applied physiology (Bethesda, Md. : 1985) . Vol. 93, No. 4, 2002 Oct
|
Although it is well established that severe chronic hyperglycemia is associated with microvascular disease, it is not known whether transient hyperglycemia similar to that observed with impaired glucose tolerance or early Type 2 diabetes contributes to this pathology by altering microvascular function. To test the hypothesis that acute hyperglycemia decreases microvascular vasodilator responsiveness in human skin, we measured the cutaneous vasodilator response to local warming. This response can be divided into two phases, an initial peak that relies predominantly on local sensory nerves and a second slower phase that is largely dependent on endothelial nitric oxide. We reasoned that a change in one or both phases would indicate a change in the corresponding mechanism(s) with hyperglycemia. Twenty-eight healthy volunteers (14 women, 14 men) were randomly divided into three groups, corresponding to 6 h of euglycemia (n = 8), 6 h when glucose was clamped at approximately 7 mmol/l (n = 10), or 6 h when glucose was varied to mimic a postprandial pattern (i.e., peak glucose approximately 11.1 mmol/l) commonly observed in individuals with impaired glucose tolerance (n = 10). Insulin concentrations in all instances were maintained at approximately 65 pmol/l by means of continuous infusions of somatostatin and insulin. Glucagon and growth hormone were also continuously infused to maintain their basal concentrations. Despite substantial differences in both the level and pattern of glucose concentrations, neither maximum cutaneous vasodilation nor the pattern of the vasodilator response to local warming differed over the 6 h of study. We conclude that acute hyperglycemia similar to levels commonly observed in people with either early Type 2 diabetes or impaired glucose tolerance does not alter the vasodilator response to local warming of the skin in humans.
|
https://pubmed.ncbi.nlm.nih.gov/12235021/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, U.S. Gov't, P.H.S."
] |
12235021
|
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] |
12,235,022 |
Glutamate ingestion and its effects at rest and during exercise in humans.
|
Mourtzakis Marina M, Graham Terry E TE
|
Journal of applied physiology (Bethesda, Md. : 1985) . Vol. 93, No. 4, 2002 Oct
|
Glutamate is central to several transamination reactions that affect the production of ammonia, alanine, glutamine, as well as TCA cycle intermediates during exercise. To further study glutamate metabolism, we administered 150 mg/kg body wt of monosodium glutamate (MSG) and placebo to seven male subjects who then either rested or exercised (15-min cycling at approximately 85% maximal oxygen consumption). MSG ingestion resulted in elevated plasma glutamate, aspartate, and taurine, both at rest and during exercise (P < 0.05), whereas most other amino acids were unchanged. Neither plasma alanine nor ammonia was altered at rest. During exercise and after glutamate ingestion, alanine was increased (P < 0.05) and ammonia was attenuated (P < 0.05). Glutamine was also elevated after glutamate ingestion during rest and exercise trials. MSG administration also resulted in elevated insulin levels (P < 0.05), which were parallel to the trend in C-peptide levels. Thus MSG can successfully elevate plasma glutamate, both at rest and during exercise. The plasma amino acid responses suggest that increased glutamate availability during exercise alters its distribution in transamination reactions within active muscle, which results in elevated alanine and decreased ammonia levels.
|
https://pubmed.ncbi.nlm.nih.gov/12235022/
|
[
"Clinical Trial",
"Controlled Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12235022
|
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] |
12,235,071 |
Double blind, randomised, placebo controlled study of four weeks of lansoprazole for the treatment of functional dyspepsia in Chinese patients.
|
Wong W M WM, Wong B C Y BC, Hung W K WK, Yee Y K YK, Yip A W C AW, Szeto M L ML, Fung F M Y FM, Tong T S M TS, Lai K C KC, Hu W H C WH, Yuen M F MF, Lam S K SK
|
Gut . Vol. 51, No. 4, 2002 Oct
|
BACKGROUND: The use of proton pump inhibitors for the treatment of functional dyspepsia is controversial and the role of Helicobacter pylori infection in functional dyspepsia is uncertain. AIM: To evaluate the efficacy of different doses of lansoprazole for the treatment of functional dyspepsia in Chinese patients. METHOD: Patients with a clinical diagnosis of functional dyspepsia according to the Rome II criteria and normal upper gastrointestinal endoscopy were recruited and randomised to receive: (1) lansoprazole 30 mg, (2) lansoprazole 15 mg, or (3) placebo, all given daily for four weeks. Dyspepsia symptom scores and quality of life (SF-36 score) were evaluated before and four weeks after treatment. RESULTS: A total of 453 patients were randomised. There was no difference in the proportion of patients with complete symptom relief in the lansoprazole 30 mg (23%) and lansoprazole 15 mg (23%) groups compared with the placebo group (30%). The proportion of H pylori positive patients with a complete response was similar with lansoprazole 30 mg (34%) and lansoprazole 15 mg (20%) versus placebo (22%). All symptom subgroups (ulcer-like, dysmotility-like, reflux-like, and unspecified dyspepsia) had similar proportions of patients with complete symptom relief after treatment. CONCLUSION: Proton pump inhibitor treatment is not superior to placebo for the management of functional dyspepsia in Chinese patients.
|
https://pubmed.ncbi.nlm.nih.gov/12235071/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12235071
|
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] |
12,235,178 |
Effect of atorvastatin on plasma apoE metabolism in patients with combined hyperlipidemia.
|
Cohn Jeffrey S JS, Tremblay Michel M, Batal Rami R, Jacques Hélène H, Veilleux Lyne L, Rodriguez Claudia C, Barrett P Hugh R PH, Dubreuil Denise D, Roy Madeleine M, Bernier Lise L, Mamer Orval O, Davignon Jean J
|
Journal of lipid research . Vol. 43, No. 9, 2002 Sep
|
Atorvastatin, a synthetic HMG-CoA reductase inhibitor used for the treatment of hyperlipidemia and the prevention of coronary artery disease, significantly lowers plasma cholesterol and low-density lipoprotein cholesterol (LDL-C) levels. It also reduces total plasma triglyceride and apoE concentrations. In view of the direct involvement of apoE in the pathogenesis of atherosclerosis, we have investigated the effect of atorvastatin treatment (40 mg/day) on in vivo rates of plasma apoE production and catabolism in six patients with combined hyperlipidemia using a primed constant infusion of deuterated leucine. Atorvastatin treatment resulted in a significant decrease (i.e., 30-37%) in levels of total triglyceride, cholesterol, LDL-C, and apoB in all six patients. Total plasma apoE concentration was reduced from 7.4 +/- 0.9 to 4.3 +/- 0.2 mg/dl (-38 +/- 8%, P < 0.05), predominantly due to a decrease in VLDL apoE (3.4 +/- 0.8 vs. 1.7 +/- 0.2 mg/dl; -42 +/- 11%) and IDL/LDL apoE (1.9 +/- 0.3 vs. 0.8 +/- 0.1 mg/dl; -57 +/- 6%). Total plasma lipoprotein apoE transport (i.e., production) was significantly reduced from 4.67 +/- 0.39 to 3.04 +/- 0.51 mg/kg/day (-34 +/- 10%, P < 0.05) and VLDL apoE transport was reduced from 3.82 +/- 0.67 to 2.26 +/- 0.42 mg/kg/day (-36 +/- 10%, P = 0.057). Plasma and VLDL apoE residence times and HDL apoE kinetic parameters were not significantly affected by drug treatment. Percentage decreases in VLDL apoE concentration and VLDL apoE production were significantly correlated with drug-induced reductions in VLDL triglyceride concentration (r = 0.99, P < 0.001; r = 0.88, P < 0.05, respectively, n = 6). Our results demonstrate that atorvastatin causes a pronounced decrease in total plasma and VLDL apoE concentrations and a significant decrease in plasma and VLDL apoE rates of production in patients with combined hyperlipidemia.
|
https://pubmed.ncbi.nlm.nih.gov/12235178/
|
[
"Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, P.H.S."
] |
12235178
|
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0.11815544962882996,
0.38317811489105225,
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] |
12,235,246 |
Effects of folate treatment and homocysteine lowering on resistance vessel reactivity in atherosclerotic subjects.
|
Stanger Olaf O, Semmelrock Hans-Juergen HJ, Wonisch Willibald W, Bös Ursula U, Pabst Edmund E, Wascher Thomas C TC
|
The Journal of pharmacology and experimental therapeutics . Vol. 303, No. 1, 2002 Oct
|
Hyperhomocysteinemia is associated with arterial hypertension and endothelial dysfunction in healthy humans. Placebo-controlled vitamin intervention studies cannot distinguish intrinsic actions of homocysteine (tHcy) and folate concentrations on the endothelium. The present two-period crossover study investigates the effects of tHcy lowering through oral folic acid on antioxidant status and resistance vessel reactivity in patients with established coronary artery disease (CAD). We investigated 27 male patients with angiographically documented multivessel CAD aged 50 (range 46-56) years. Resistance vessel reactivity was assessed by measurement of postischemic reactive hyperemia (RH) in the forearm using venous occlusion plethysmography at baseline, after 6 weeks of treatment with 5 mg of oral folic acid, and after a washout period of another 6 weeks. Plasma folate increased 3.49-fold with a mean tHcy reduction of 21.3%. Peak reactivity of resistance vessels improved significantly (18.97-23.60 ml/min(-1) per 100 ml; P = 0.01) with unchanged total antioxidant status (TAS; 0.912-0.944 microM; P = 0.4). This effect was limited to subjects (n = 14) with a tHcy reduction >2 microM (median reduction, 14.4-9.6 microM, P < 0.001). In the 13 subjects with a below-median reduction, tHcy remained unaltered (9.7-9.6 microM, P = 0.88) and TAS increased significantly (0.923-1.055 microM, P = 0.006), whereas RH peak flow was not affected (20.22-22.99 ml/min(-1) per 100 ml, P = 0.28). Homocysteine lowering >2 microM through folic acid supplementation improves resistance vessel reactivity in patients with CAD. Our data support the hypothesis that homocysteine lowering may have intrinsic vasoprotective effects largely independent of folate.
|
https://pubmed.ncbi.nlm.nih.gov/12235246/
|
[
"Clinical Trial",
"Comparative Study",
"Controlled Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12235246
|
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] |
12,235,304 |
Testing cognitive function in elderly populations: the PROSPER study. PROspective Study of Pravastatin in the Elderly at Risk.
|
Houx P J PJ, Shepherd J J, Blauw G-J GJ, Murphy M B MB, Ford I I, Bollen E L EL, Buckley B B, Stott D J DJ, Jukema W W, Hyland M M, Gaw A A, Norrie J J, Kamper A M AM, Perry I J IJ, MacFarlane P W PW, Meinders A Edo AE, Sweeney B J BJ, Packard C J CJ, Twomey C C, Cobbe S M SM, Westendorp R G RG
|
Journal of neurology, neurosurgery, and psychiatry . Vol. 73, No. 4, 2002 Oct
|
OBJECTIVES: For large scale follow up studies with non-demented patients in which cognition is an endpoint, there is a need for short, inexpensive, sensitive, and reliable neuropsychological tests that are suitable for repeated measurements. The commonly used Mini-Mental-State-Examination fulfils only the first two requirements. METHODS: In the PROspective Study of Pravastatin in the Elderly at Risk (PROSPER), 5804 elderly subjects aged 70 to 82 years were examined using a learning test (memory), a coding test (general speed), and a short version of the Stroop test (attention). Data presented here were collected at dual baseline, before randomisation for active treatment. RESULTS: The tests proved to be reliable (with test/retest reliabilities ranging from acceptable (r=0.63) to high (r=0.88) and sensitive to detect small differences in subjects from different age categories. All tests showed significant practice effects: performance increased from the first measurement to the first follow up after two weeks. CONCLUSION: Normative data are provided that can be used for one time neuropsychological testing as well as for assessing individual and group change. Methods for analysing cognitive change are proposed.
|
https://pubmed.ncbi.nlm.nih.gov/12235304/
|
[
"Clinical Trial",
"Journal Article",
"Multicenter Study",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12235304
|
[
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] |
12,235,307 |
Effect of chronic pallidal deep brain stimulation on off period dystonia and sensory symptoms in advanced Parkinson's disease.
|
Loher T J TJ, Burgunder J-M JM, Weber S S, Sommerhalder R R, Krauss J K JK
|
Journal of neurology, neurosurgery, and psychiatry . Vol. 73, No. 4, 2002 Oct
|
OBJECTIVE: To investigate the efficacy of chronic pallidal deep brain stimulation (DBS) on off period dystonia, cramps, and sensory symptoms in advanced Parkinson's disease (PD). METHODS: 16 patients (6 women, 10 men; mean age at surgery 65 years) suffering from advanced PD were followed up prospectively for one year after implantation of a monopolar electrode in the posteroventral lateral globus pallidus internus. Unilateral DBS was performed in 9 patients. 10 patients had bilateral procedures (contemporaneous bilateral surgery in 7 and staged bilateral surgery in 3 instances). The decision whether to perform unilateral or bilateral surgery depended on the clinical presentation of the patient. Patients were formally assessed preoperatively, at 3-5 days, 3 months, and 12 months after surgery. RESULTS: In patients who underwent unilateral surgery, pain was present in 7 (78%), off dystonia in 5 (56%), cramps in 6 (67%), and dysaesthesia in 4 (44%). In patients who underwent bilateral surgery, pain was present in 7 (70%), off dystonia in 6 (60%), cramps in 7 (70%), and dysaesthesia in 4 (40%). With unilateral DBS, contralateral off period dystonia was improved by 100% at 1 year postoperatively, pain by 74%, cramps by 88%, and dysaesthesia by 100%. There was less pronounced amelioration of ipsilateral off period dystonia and sensory symptoms. With bilateral DBS, total scores for dystonia were improved by 86%, for pain by 90%, for cramps by 90%, and for dysaesthesia by 88%. The benefit appeared early at the first evaluation 3-5 days after surgery and was stable throughout the follow up period. CONCLUSIONS: Pallidal DBS yields major improvement of off period dystonia, cramps, and sensory symptoms in patients with advanced PD.
|
https://pubmed.ncbi.nlm.nih.gov/12235307/
|
[
"Clinical Trial",
"Journal Article"
] |
12235307
|
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] |
12,235,444 |
Evaluation of potential losartan-phenytoin drug interactions in healthy volunteers.
|
Fischer Tracy L TL, Pieper John A JA, Graff Donald W DW, Rodgers Jo E JE, Fischer Jeffrey D JD, Parnell Kimberly J KJ, Goldstein Joyce A JA, Greenwood Robert R, Patterson J Herbert JH
|
Clinical pharmacology and therapeutics . Vol. 72, No. 3, 2002 Sep
|
BACKGROUND: Phenytoin, a cytochrome P450 (CYP) 2C9 substrate, has a narrow therapeutic index and nonlinear pharmacokinetics. Therefore there is the potential for significant concentration-related adverse effects when phenytoin is coadministered with other CYP2C9 substrates. Losartan, an antihypertensive agent, is also a substrate for CYP2C9. OBJECTIVE: Our objective was to assess the effects of losartan on the pharmacokinetics of phenytoin and the effects of phenytoin on the pharmacokinetics of losartan in a healthy population of volunteers. METHODS: A prospective, randomized, 3-period crossover study was conducted in 16 healthy volunteers with phenytoin alone, phenytoin in combination with losartan, and losartan alone. Each treatment was given for 10 days with a 3-week washout period between treatments. On day 10, plasma concentrations of phenytoin and plasma and urine concentrations of losartan and its active carboxylic-acid metabolite E3174 were measured to determine steady-state pharmacokinetic parameters. RESULTS: Coadministration of losartan had no effect on the pharmacokinetics of phenytoin. Coadministration of phenytoin increased the mean area under the concentration-time curve from time zero to 24 hours [AUC(0-24)] of losartan by 17% (355 +/- 220 ng x h/mL versus 427 +/- 177 ng x h/mL; P =.1), but this difference was not statistically significant. In the 14 CYP2C9*1/*1 subjects, the mean AUC(0-24) of losartan was increased by 29% (284 +/- 84 ng x h/mL versus 402 +/- 128 ng x h/mL; P =.008). Coadministration of phenytoin significantly reduced the AUC(0-24) of E3174 by 63% (1254 +/- 256 ng x h/mL versus 466 +/- 174 ng x h/mL; P =.0001) and the formation clearance of losartan to E3174 (1.91 +/- 0.8 mL/h per kilogram versus 0.62 +/- 0.4 mL/h per kilogram; P =.0001). CONCLUSIONS: Losartan, a CYP2C9 substrate, had no effect on the pharmacokinetics of phenytoin. However, phenytoin inhibited the CYP2C9-mediated conversion of losartan to E3174.
|
https://pubmed.ncbi.nlm.nih.gov/12235444/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, P.H.S."
] |
12235444
|
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] |
12,235,445 |
Evaluation of peppermint oil and ascorbyl palmitate as inhibitors of cytochrome P4503A4 activity in vitro and in vivo.
|
Dresser George K GK, Wacher Vincent V, Wong Susan S, Wong Harrison T HT, Bailey David G DG
|
Clinical pharmacology and therapeutics . Vol. 72, No. 3, 2002 Sep
|
OBJECTIVES: Our study was designed to determine the effect of peppermint oil and ascorbyl palmitate on cytochrome P4503A4 (CYP3A4) activity in vitro and oral bioavailability of felodipine in humans. METHODS: Reversible and mechanism-based inhibitions of nifedipine oxidation were studied in human liver microsomes. The oral pharmacokinetics of felodipine and its dehydrofelodipine metabolite were determined in 12 healthy volunteers after administration of felodipine, 10-mg extended-release tablet, with grapefruit juice (300 mL), peppermint oil (600 mg), ascorbyl palmitate (500 mg), or water in a randomized 4-way crossover study. RESULTS: Peppermint oil (inhibition constant [K(i)] = 35.9 +/- 3.3 microg/mL, mean +/- SEM) and 2 constituents, menthol (K(i) = 87.0 +/- 7.0 micromol/L), and menthyl acetate (K(i) = 124.0 +/- 7.0 micromol/L), produced reversible inhibition of nifedipine oxidation. Ascorbyl palmitate was more potent (K(i) = 12.3 +/- 0.5 micromol/L). None of these substances were mechanism-based inhibitors. Grapefruit juice and peppermint oil increased the area under the curve (AUC) values of felodipine to 173% (range, 94%-280%; P <.01) and 140% (range, 77%-262%; P <.05), respectively, of those with water. They augmented the peak plasma concentration (C(max)) of felodipine and the AUC and C(max) of dehydrofelodipine but did not alter the half-life (t(1/2)) of either substance. Grapefruit juice decreased the dehydrofelodipine/felodipine AUC ratio, but peppermint oil did not. Ascorbyl palmitate did not change the pharmacokinetics of felodipine or dehydrofelodipine compared with water. CONCLUSIONS: Peppermint oil, menthol, menthyl acetate, and ascorbyl palmitate were moderately potent reversible inhibitors of in vitro CYP3A4 activity. Grapefruit juice increased the oral bioavailability of felodipine by inhibition of CYP3A4-mediated presystemic drug metabolism. Peppermint oil may also have acted by this mechanism. However, this requires further investigation. Ascorbyl palmitate did not inhibit CYP3A4 activity in vivo.
|
https://pubmed.ncbi.nlm.nih.gov/12235445/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12235445
|
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] |
12,235,448 |
Cytochrome P450 phenotypic ratios for predicting herb-drug interactions in humans.
|
Gurley Bill J BJ, Gardner Stephanie F SF, Hubbard Martha A MA, Williams D Keith DK, Gentry W Brooks WB, Cui Yanyan Y, Ang Catharina Y W CY
|
Clinical pharmacology and therapeutics . Vol. 72, No. 3, 2002 Sep
|
OBJECTIVES: Phytochemical-mediated modulation of cytochrome P450 (CYP) activity may underlie many herb-drug interactions. Single-time point phenotypic metabolic ratios were used to determine whether long-term supplementation of St John's wort, garlic oil, Panax ginseng, and Ginkgo biloba affected CYP1A2, CYP2D6, CYP2E1, or CYP3A4 activity. METHODS: Twelve healthy volunteers (6 females) were randomly assigned to receive either St John's wort, garlic oil, P ginseng, or G biloba for 28 days. For each subject, a 30-day washout period was interposed between each supplementation phase. Probe-drug cocktails of midazolam, caffeine, chlorzoxazone, and debrisoquin (INN, debrisoquine) were administered before supplementation (baseline) and at the end of supplementation. Presupplementation and postsupplementation phenotypic trait measurements were determined for CYP3A4, CYP1A2, CYP2E1, and CYP2D6 with the use of 1-hydroxymidazolam/midazolam serum ratios (1-hour sample), paraxanthine/caffeine serum ratios (6-hour sample), 6-hydroxychlorzoxazone/chlorzoxazone serum ratios (2-hour sample), and debrisoquin urinary recovery ratios (8-hour collection), respectively. RESULTS: Comparisons of presupplementation and postsupplementation ratios indicated that St John's wort significantly induced the activity of CYP2E1 and CYP3A4 (P <.0001). Among female subjects, St John's wort produced significantly greater increases in CYP3A4 phenotypic ratios that appeared to be unrelated to body mass index. This finding is suggestive of a sexual dimorphism in CYP3A4 inducibility. Garlic oil reduced CYP2E1 activity by 39% (P =.030), whereas no significant effect on CYP activity was observed for P ginseng and G biloba. CONCLUSIONS: Single-time point phenotypic metabolic ratios may provide a practical means of predicting CYP-mediated herb-drug interactions in humans.
|
https://pubmed.ncbi.nlm.nih.gov/12235448/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12235448
|
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] |
12,235,450 |
Atovaquone plus chloroguanide versus mefloquine for malaria prophylaxis: a focus on neuropsychiatric adverse events.
|
van Riemsdijk M M MM, Sturkenboom M C J M MC, Ditters J M JM, Ligthelm R J RJ, Overbosch D D, Stricker B H Ch BH
|
Clinical pharmacology and therapeutics . Vol. 72, No. 3, 2002 Sep
|
OBJECTIVES: We performed a prospective, double-blind, randomized study to compare the occurrence of neuropsychiatric adverse events and concentration impairment during prophylactic use of either mefloquine or atovaquone plus chloroguanide (INN, proguanil). METHODS: Our potential study population consisted of all persons who were included in the MAL30010 trial at the Travel Clinic, Rotterdam, The Netherlands. All subjects were randomized to receive either active atovaquone (250 mg) plus chloroguanide (100 mg) daily plus a placebo for mefloquine weekly or active mefloquine (250 mg) weekly plus a placebo for atovaquone plus chloroguanide daily. Each subject was followed up from a baseline screening visit up to the index date, 7 days after he or she left the malaria-endemic area. We measured the interindividual and intraindividual changes in mood disturbance by means of the Dutch shortened Profile of Mood States and 3 domains of the Neurobehavioral Evaluation System, which included sustained attention, coding speed, and visuomotor accuracy between baseline and follow-up visit. RESULTS: The cohort consisted of 119 subjects with a mean age of 35 years. A significant deterioration in depression, anger, fatigue, vigor, and total mood disturbance domains occurred during use of mefloquine but not during use of atovaquone plus chloroguanide. Stratification for sex showed between-treatment differences in female patients but not in male patients. In both treatment groups, sustained attention deteriorated after travel, especially with increased duration of stay. CONCLUSIONS: Prophylactic use of mefloquine was associated with significantly higher scores on scales for depression, anger, and fatigue and lower scores for vigor than prophylactic use of atovaquone plus chloroguanide.
|
https://pubmed.ncbi.nlm.nih.gov/12235450/
|
[
"Clinical Trial",
"Clinical Trial, Phase III",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12235450
|
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12,235,451 |
Losartan and lercanidipine attenuate low-density lipoprotein oxidation in patients with hypertension and type 2 diabetes mellitus: a randomized, prospective crossover study.
|
Rachmani Rita R, Levi Zohar Z, Zadok Bat-Sheva BS, Ravid Mordchai M
|
Clinical pharmacology and therapeutics . Vol. 72, No. 3, 2002 Sep
|
OBJECTIVES: Lipoprotein oxidation, dyslipidemia, and hypertension are important underlying causes of accelerated atherosclerosis in patients with diabetes mellitus. The potential of antihypertensive medications to reduce lipid oxidation is, therefore, an important determinant in the choice of agents for patients with diabetes mellitus. The aim of this study was to compare the lowering effect of a new dihydropyridine calcium antagonist, lercanidipine, with that of the first angiotensin-receptor blocker, losartan, on low-density lipoprotein (LDL) oxidation. METHODS: Forty patients in metabolically stable condition who had type 2 diabetes mellitus with hypertension were studied in this single-blind, randomized, prospective crossover study, comprising 2 treatment periods of 16 weeks each, separated by a 4-week washout period. LDL oxidation was evaluated by dialdehyde analysis by means of the thiobarbituric acid-reactive substances assay with and without cupric sulfate, as well as determination of conjugated dienes in the LDL lipid extract. RESULTS: Lercanidipine and losartan both significantly reduced the propensity of the serum to oxidize LDL (P =.001). With one method of estimation (conjugated dienes), the effect of lercanidipine was superior to that of losartan (P =.04). Losartan lowered urinary albumin excretion but lercanidipine did not. CONCLUSIONS: Both lercanidipine and losartan attenuate LDL oxidation in patients with type 2 diabetes mellitus and hypertension. This observation may offer insight into the mechanisms of the therapeutic effects of these agents in patients with diabetes mellitus.
|
https://pubmed.ncbi.nlm.nih.gov/12235451/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial"
] |
12235451
|
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