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12,227,872 |
Comparative efficacy of clindamycin and benzoyl peroxide for in vivo suppression of Propionibacterium acnes.
|
Gans E H EH, Kligman A M AM
|
The Journal of dermatological treatment . Vol. 13, No. 3, 2002 Sep
|
BACKGROUND: Benzoyl peroxide and clindamycin are the two most widely prescribed topical antimicrobials in the treatment of acne. AIM: To compare the antimicrobial efficacy, in vivo, of benzoyl peroxide and clindamycin against Propionibacterium acnes. METHODS: Two groups of 10 subjects each, with comparable mean P. acnes baseline counts of log 5.75 to 5.85, underwent twice daily application of benzoyl peroxide or clindamycin for 14 days. RESULTS: The results of quantitatively sampling P. acnes after 3, 7 and 14 days of treatment showed that Triaz 6% benzoyl peroxide special gel produced faster and significantly greater reductions in P. acnes than did the 1% clindamycin phosphate in Cleocin-T lotion (p < 0.01). These results were paralleled by the greater reductions produced by Triaz versus Cleocin (p < 0.05) in P. acnes fluorescence. CONCLUSION: Benzoyl peroxide formulations suppress the follicular population of P. acnes more rapidly and to a greater degree than topical antibiotics such as clindamycin.
|
https://pubmed.ncbi.nlm.nih.gov/12227872/
|
[
"Clinical Trial",
"Comparative Study",
"Controlled Clinical Trial",
"Journal Article"
] |
12227872
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12,227,873 |
Clinical evaluation of Double Strength Isotrexin versus Benzamycin in the topical treatment of mild to moderate acne vulgaris.
|
Marazzi P P, Boorman G C GC, Donald A E AE, Davies H D HD
|
The Journal of dermatological treatment . Vol. 13, No. 3, 2002 Sep
|
BACKGROUND: Topical retinoid therapy has been shown to be an effective means of treating both the inflammatory and non-inflammatory lesions of acne vulgaris. AIM: To assess the efficacy and safety of the test product, a gel containing isotretinoin 0.1% w/w and erythromycin 4.0% w/w, with a currently used and effective treatment for mild to moderate acne vulgaris, a gel containing benzoyl peroxide 5.0% w/w and erythromycin 3.0% w/w. METHODS: This multi-centre, single-blind (investigator blind), parallel group study compared the efficacy and safety of isotretinoin/erythromycin gel (Double Strength Isotrexin) once daily against benzoyl peroxide/erythromycin gel (Benzamycin twice daily in the topical treatment of mild to moderate acne vulgaris. Patients (n = 188) with a history (mean duration 3.3 years) of facial acne vulgaris and with 15-100 inflammatory lesions and/or 15-100 non-inflammatory lesions, but not more than three nodulocystic lesions, were included. At baseline and weeks 2, 4, 8 and 12, the investigator assessed efficacy (total number and severity of inflammatory and non-inflammatory lesions and acne grade) while subjective global change assessments of facial acne from baseline and symptom-specific skin tolerance were assessed by the patient. The investigator recorded an overall global assessment of skin tolerability at week 12. Adverse events were recorded throughout. RESULTS: The treatments were comparable with regard to their effects on inflammatory and non-inflammatory lesions and acne grade. Few adverse events were considered to be treatment-related. Both the isotretinoin/erythromycin and benzoyl peroxide/erythromycin gels were generally well tolerated. Compliance was better with the isotretinoin/erythromycin gel, which had the advantages of not requiring mixing or storage in a refrigerator, and was applied once rather than twice daily. CONCLUSIONS: Isotretinoin/erythromycin gel given only once daily showed comparable efficacy with benzoyl peroxide/erythromycin given twice daily in the treatment of mild to moderate acne vulgaris of the face.
|
https://pubmed.ncbi.nlm.nih.gov/12227873/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Multicenter Study",
"Randomized Controlled Trial"
] |
12227873
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12,227,876 |
Limited benefit of topical calcipotriol in lichen planus treatment: a preliminary study.
|
Bayramgürler D D, Apaydin R R, Bilen N N
|
The Journal of dermatological treatment . Vol. 13, No. 3, 2002 Sep
|
BACKGROUND: Lichen planus (LP) is a papulosquamous dermatosis in which immunologic mechanisms play an important role in its pathogenesis. Topical calcipotriol, which mainly stimulates differentiation and inhibits proliferation of keratinocytes, also has immunosuppressive and anti-inflammatory functions. AIM: To investigate the therapeutical effects of topical calcipotriol in LP. METHODS: A total of 18 histopathologically proved LP patients were advised to apply calcipotriol ointment twice daily to all affected skin areas except genitalia. Clinical evaluation of all patients was performed monthly and response to treatment was assessed on clinical grounds (erythematous and/or violaceous color, thickness and scale of the lesions) as partial, complete or no response. If there was no response at the end of the second month, topical calcipotriol was stopped. If there was partial clinical improvement at the end of the second month, the treatment was continued for one additional month. RESULTS: In all, 16 patients completed the study. Of the study population, 56.25% (9/16) responded to topical calcipotriol treatment which was used for a maximum of 3 months. Complete clearing of the lesions with post-inflammatory hyperpigmentation and partial improvement were obtained in 31.25% (5/16) and 25% (4/16) of the patients, respectively. No improvement was observed in 43.75% (7/16) of the patients. CONCLUSION: Topical calcipotriol can be used in the treatment of LP as a therapeutic option, although it is not the first-choice drug.
|
https://pubmed.ncbi.nlm.nih.gov/12227876/
|
[
"Clinical Trial",
"Journal Article"
] |
12227876
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] |
12,227,885 |
Cyclic progestin therapy for the management of mastopathy and mastodynia.
|
Winkler U H UH, Schindler A E AE, Brinkmann U S US, Ebert C C, Oberhoff C C
|
Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology . Vol. 15 Suppl 6, 2001 Dec
|
The management of benign diseases of the breast aims to halt the progression of fibrocystic transformation and to eliminate the symptoms of pain and breast tenderness. Progestins can be used for this purpose. In a controlled, randomized, double-blind, parallel-group study we treated 31 women with mastopathy/mastodynia with the progestins medrogestone (10 mg/day) or dydrogesterone (10 mg/day) from day 14 to day 25 for six cycles. Before, during and at the end of therapy the following parameters were evaluated: subjective symptoms (pain, tenderness, impairment of daily activities), palpatory findings, sonographic diagnosis and sex hormone profiles. Cyclic administration of the low-dose progestins medrogestone and dydrogesterone proved to be an effective and safe treatment of mastodynia and mastopathy. The objective parameters palpatory findings and sonographic imaging of breast nodules and cysts improved in more than 50% of patients. Improvement was particularly marked in women with low progesterone levels in the second half of the cycle. After six treatment cycles, 75% of the patients treated with dydrogesterone and 86% of the patients treated with medrogestone were completely pain-free.
|
https://pubmed.ncbi.nlm.nih.gov/12227885/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12227885
|
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] |
12,227,888 |
Levels of estrogen and progesterone receptors in the myometrium and leiomyoma tissue after suppression of estrogens with gonadotropin releasing hormone analogs.
|
van de Ven J J, Sprong M M, Donker G H GH, Thijssen J H JH, Mak-Kregar S S, Blankenstein M A MA
|
Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology . Vol. 15 Suppl 6, 2001 Dec
|
Gonadotropin releasing hormone (GnRH) agonists are successfully used in the treatment of uterine leiomyomas. Different GnRH agonists may have different local effects on steroid receptors. This study was designed to evaluate potential differences in this respect between triptorelin (Decapeptyl) and goserelin (Zoladex) in a randomized controlled multicenter study using untreated patients during the luteal phase of their menstrual cycle as controls. Estrogen receptors (ERs) and progestin receptors (PRs) were measured by ligand binding assay in myoma and myometrium tissue following a 4-month treatment course with one of the GnRH analogs. In 18 untreated patients median values of ER and PR contents were comparable in myoma and myometrium: for ER at median levels of 56 and 43 fmol/mg protein, respectively; and for PR, median binding capacities were 690 and 730 fmol/mg protein, respectively. Both types of GnRH treatment (total number of patients 34) were associated with significant rises in ER in myoma (to a median level of 279 fmol/mg protein, p<0.001) and myometrium (to a median level of 109 fmol/mg protein, p<0.01). The increase in ER in myomas was significantly (p<0.001) greater than in myometria of the same patients (n=30). After treatment, PR in myomas (median level 520 fmol/mg protein) did not change significantly, but a significant (p<0.05) decrease was found for myometria (median level of 320 fmol/mg protein). Thus, ER and PR concentrations in myoma and myometrium are comparable before treatment, but estrogen suppression with GnRH analogs leads to a larger increase of ER level in leiomyomas than in myometrium, without an effect on PR, whereas myometria had lower PR levels. Therefore, leiomyoma reacts differently from myometrium towards lowered steroid concentrations in the circulation. Since the PR is considered to be a marker of estrogenic stimulation, this indicates remaining estrogenic effects on leiomyomas despite the large decrease of plasma estrogen concentrations.
|
https://pubmed.ncbi.nlm.nih.gov/12227888/
|
[
"Clinical Trial",
"Journal Article",
"Multicenter Study",
"Randomized Controlled Trial"
] |
12227888
|
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] |
12,227,986 |
Human immunodeficiency virus-related anemia of chronic disease: relationship to hematologic, immune, and iron metabolism parameters, and lack of association with serum interferon-gamma levels.
|
Salomé Marina A MA, Grotto Helena Z W HZ
|
AIDS patient care and STDs . Vol. 16, No. 8, 2002 Aug
|
Anemia of chronic disease (ACD) is frequent in patients with human immunodeficiency virus (HIV) and its etiology is multifactorial. In a group of 111 patients with HIV, 19 were diagnosed with ACD. Parameters related to iron metabolism, such as serum iron (SI), serum ferritin (SF), and soluble transferrin receptor (sTfR) were correlated to levels of interferon-gamma (IFN-gamma) and results compared to a group of 42 nonanemic patients with HIV. Measurements of erythropoietin (EPO), CD4/CD8 T-cell ratio, and reticulocyte count (RTC) were determined to verify aspects related to severity of disease and bone marrow response. The results showed higher SF concentrations in ACD patients and normal or slightly increased sTfR measurements in both groups. There was no correlation between IFN-gamma and SF and between IFN-gamma and sTfR determinations. Lower CD4/CD8 values were obtained in ACD, and an inverse correlation was observed between IFN-gamma and CD4/CD8 in groups with and without anemia. RTC counts and EPO concentrations were similar in both groups: immature RTC were increased in patients with anemia, indicating an apparent attempt of marrow response to compensate the increased demand. Our data showed no correlation between IFN-gamma levels and iron disturbances in ACD, but results reinforced the observation of enhanced immunologic system deterioration in patients with HIV and ACD.
|
https://pubmed.ncbi.nlm.nih.gov/12227986/
|
[
"Clinical Trial",
"Journal Article"
] |
12227986
|
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] |
12,228,083 |
Randomized trial of an internet curriculum on herbs and other dietary supplements for health care professionals.
|
Kemper Kathi J KJ, Amata-Kynvi Andey A, Sanghavi Darshak D, Whelan Julia S JS, Dvorkin Lana L, Woolf Alan A, Samuels Ronald C RC, Hibberd Patricia P
|
Academic medicine : journal of the Association of American Medical Colleges . Vol. 77, No. 9, 2002 Sep
|
PURPOSE: Herbs and dietary supplements are widely used, and there is an urgent need to educate health professionals about their risks and benefits. The Internet provides an innovative way of educating busy health professionals. This study assessed the impact of an Internet-based curriculum on health professionals' knowledge, confidence, and clinical practices related to herbs and dietary supplements. METHOD: The study was a randomized crossover trial involving physicians, pharmacists, advanced practice nurses, and dietitians. Participants were invited by e-mail and randomly assigned to immediate intervention versus waiting-list groups (n = 537). The curriculum lasted ten weeks and consisted of 20 case-based modules, each involving one multiple-choice or true-or-false question and its answer, links to reliable Internet sources of additional information, and a moderated listserv discussion group. Participants were surveyed about their knowledge, confidence, and communication related to herbs and dietary supplements on enrollment, after the immediate intervention group had completed the curriculum, and after the waiting-list group completed the curriculum. RESULTS: Baseline scores for knowledge, confidence, and communication were similar in the two groups. At the first follow-up, there was greater improvement in scores for all three areas in the immediate intervention group than in the waiting-list group (improvement for knowledge, 3.0 versus 1.4; confidence, 2.6 versus 0.6; communication, 0.21 versus -0.1, p <.01 for all comparisons). After all participants had received the curriculum, scores for both groups were significantly better than at baseline and similar to one another. CONCLUSION: Internet-based education about herbs and dietary supplements for diverse health professionals is feasible and results in significant and sustained improvements in knowledge, confidence, and communication practices.
|
https://pubmed.ncbi.nlm.nih.gov/12228083/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, U.S. Gov't, P.H.S."
] |
12228083
|
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12,228,100 |
Implementing a systematic course/clerkship peer review process.
|
Burke Michael J MJ, Bonaminio Giulia G, Walling Anne A
|
Academic medicine : journal of the Association of American Medical Colleges . Vol. 77, No. 9, 2002 Sep
|
OBJECTIVE: A systematic course/clerkship peer-review process was developed to meet several objectives: improvement of quality of course/clerkship, enhancement of understanding of individual course and overall curricular content, improvement of communication and collaboration between basic science and clinical disciplines across campuses, provision of forum to address curricular concerns of students and faculty, facilitation of data collection for LCME reviews and the AAMC CurrMIT project; and monitoring curricular equivalency at multiple clinical sites. DESCRIPTION: Previously each course had carried out an internal review process. These reviews varied considerably in terms of the data collected and how those data were used for quality improvement. Data and outcomes of the internal reviews were seldom shared with colleagues, students, or administrators. This limited communication discouraged collaboration and led to disparity in curricular content between campuses. A collaborative effort between the medical school's Office of Medical Education (OME) and the Education Council, the faculty governance committee composed of faculty from each basic science and clinical department on each campus, has led to the development and implementation of a systematic course/clerkship peer-review process. Two standing committees of the Education Council oversee the systematic review process. One committee is charged with oversight of the first two years of the curriculum and a second committee with oversight of the third and fourth years. A two-tiered course/clerkship review process was designed with all courses undergoing a limited annual review. A comprehensive, "nuts and bolts" review for required courses was to occur every three years. The limited annual review was based on course evaluations completed by students, collected and summarized by the OME, and presented to the Education Council. The comprehensive review of a required course/clerkship occurred over a six-to-eight-month period. Course directors on each campus completed a questionnaire and submitted materials. To facilitate cross-discipline communication and synergy, a subcommittee composed of both basic science and clinical faculty, principally course directors, and at least one medical student who had completed the course at each campus reviewed submitted materials and had a series of meetings with the course directors, support personnel, and department chairs. Final review reports presented to the Education Council identify issues, concerns, and recommendations for action. To date 11 required courses have completed the comprehensive review process. Simple oversights, significant curricular disparity between campuses, and opportunities for multidisciplinary collaboration have been identified and addressed. Student-rated satisfaction has improved for those courses that have been reviewed. DISCUSSION: The systematic course/clerkship peer-review process has been a success, although there was initial resistance to "outside review." We have not yet completed one cycle of comprehensive course reviews but already faculty and administration have a better understanding of individual course and overall curriculum content. Faculty have developed working relationships and are sharing educational strategies across disciplines and campuses, and identifying innovative collaborations. The annual review process is now perceived to lack depth and is under reconsideration.
|
https://pubmed.ncbi.nlm.nih.gov/12228100/
|
[
"Journal Article",
"Review",
"Systematic Review"
] |
12228100
|
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12,228,157 |
Clinical outcome in 22 patients with rheumatoid arthritis treated with B lymphocyte depletion.
|
Leandro M J MJ, Edwards J C W JC, Cambridge G G
|
Annals of the rheumatic diseases . Vol. 61, No. 10, 2002 Oct
|
OBJECTIVES: To obtain evidence for dose response and to extend evidence of safety and efficacy for B lymphocyte depletion in rheumatoid arthritis. METHODS: Twenty two patients with rheumatoid arthritis received a total of 29 treatments with five different combinations of rituximab (RTX), cyclophosphamide (CP), and/or high dose prednisolone (PR) on an open basis as follows; cohort I: RTX 1400 mg/m(2), CP 750x2+PR; cohort II: RTX 300-700 mg/m(2), -CP+/-PR); cohort III: RTX 600-700 mg/m(2), CP 750x2+PR; cohort IV: RTX 1200 mg/m(2), CP 750x2-PR; cohort V: RTX 500 mg/m(2), CP 750x2+PR. American College of Rheumatology (ACR) criteria of improvement at six months were chosen as the primary outcome measure. Disease activity scores and total duration of improvement and of B cytopenia were also recorded. RESULTS: No major adverse events attributable to treatment were seen. ACR grades of improvement at six months were as follows: cohort I: ACR70x3, ACR50x2; cohort II: ACR20x1, ACR0x3; cohort III: ACR70x6, ACR50x2, ACR20x2; cohort IV: ACR70x2, ACR50x2, ACR20x1, ACR0x1; cohort V: ACR0x4. CONCLUSIONS: B lymphocyte depletion in rheumatoid arthritis has so far proved to be safe and associated with major improvement with protocols including RTX 600 mg/m(2) or more and CP, but not with more limited protocols. These observations provide an initial basis for the design of formal trials of B cell depletion and other B cell directed treatments, including a phase II controlled trial now in progress.
|
https://pubmed.ncbi.nlm.nih.gov/12228157/
|
[
"Clinical Trial",
"Journal Article"
] |
12228157
|
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12,228,196 |
Randomized comparison of low-dose involved-field radiotherapy and no radiotherapy for children with Hodgkin's disease who achieve a complete response to chemotherapy.
|
Nachman James B JB, Sposto Richard R, Herzog Philip P, Gilchrist Gerald S GS, Wolden Suzanne L SL, Thomson John J, Kadin Marshall E ME, Pattengale Paul P, Davis P Charlton PC, Hutchinson Raymond J RJ, White Keith K,
|
Journal of clinical oncology : official journal of the American Society of Clinical Oncology . Vol. 20, No. 18, 2002 Sep 15
|
PURPOSE: Current standard therapy for children and adolescents with Hodgkin's disease includes combination chemotherapy and low-dose involved-field radiation (LD-IFRT). Because radiation may be associated with adverse late effects, the Children's Cancer Group (CCG) investigated whether radiation could be omitted in patients achieving a complete response to initial chemotherapy without jeopardizing the excellent outcome obtained with combined-modality therapy. PATIENTS AND METHODS: Between January 1995 and December 1998, 829 eligible patients were enrolled onto CCG 5942. A total of 501 patients who achieved an initial complete response after risk-adapted combination chemotherapy were randomized to receive LD-IFRT or no further treatment. Event-free survival (EFS) and overall survival were assessed from the date of study entry or the date of randomization, as appropriate. RESULTS: The projected 3-year EFS from study entry for the entire cohort was 87% +/- 1.2%. Among patients who achieved a complete response to initial chemotherapy, 92% +/- 1.9% of those randomized to receive LD-IFRT were alive and disease free 3 years after randomization, versus 87% +/- 2.2% for patients randomized to receive no further therapy (stratified log-rank test; P =.057). With an "as-treated" analysis, 3-year EFS after randomization for the radiation cohort was 93% +/- 1.7% versus 85% +/- 2.3% for patients receiving no further therapy (stratified log-rank test; P =.0024). Three-year survival estimates for patients treated with and without LD-IFRT were 98% +/- 1.1% for patients who received radiation and 99% +/- 0.5% for patients who did not receive radiation. CONCLUSION: LD-IFRT after an initial complete response to risk-adapted chemotherapy improved EFS. At this time, there is no survival advantage for LD-IFRT, but follow-up remains short.
|
https://pubmed.ncbi.nlm.nih.gov/12228196/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, U.S. Gov't, P.H.S."
] |
12228196
|
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12,228,197 |
Phase I clinical trial of recombinant human endostatin administered as a short intravenous infusion repeated daily.
|
Eder Joseph P JP, Supko Jeffrey G JG, Clark Jeffrey W JW, Puchalski Thomas A TA, Garcia-Carbonero Rocio R, Ryan David P DP, Shulman Lawrence N LN, Proper Joann J, Kirvan Moira M, Rattner Barbara B, Connors Susan S, Keogan Mary T MT, Janicek Milos J MJ, Fogler William E WE, Schnipper Lowell L, Kinchla Nancy N, Sidor Carolyn C, Phillips Eric E, Folkman Judah J, Kufe Donald W DW
|
Journal of clinical oncology : official journal of the American Society of Clinical Oncology . Vol. 20, No. 18, 2002 Sep 15
|
PURPOSE: To perform a phase I trial of recombinant human endostatin (rhEndostatin; EntreMed, Rockville, MD) given as a daily 20-minute intravenous (IV) injection in adult patients with refractory solid tumors. PATIENTS AND METHODS: The daily dose was increased from 15 to 240 mg/m(2) by a factor of 100% in cohorts of three patients. In the absence of dose-limiting toxicity, uninterrupted treatment was continued until the tumor burden increased by more than 50% from baseline. Correlative studies included dynamic contrast-enhanced magnetic resonance imaging of tumor blood flow, urinary vascular endothelial growth factor and basic fibroblast growth factor levels, rhEndostatin serum pharmacokinetics, and monitoring of circulating antibodies to rhEndostatin. RESULTS: There were no notable treatment related toxicities among 15 patients receiving a total of 50 monthly cycles of rhEndostatin. One patient with a pancreatic neuroendocrine tumor had a minor response and two patients showed disease stabilization. Linearity in the pharmacokinetics of rhEndostatin was indicated by dose-proportionate increases in the area under the curve for the first dose and the peak serum concentration at steady state. Daily systemic exposure to rhEndostatin in patients receiving 240 mg/m(2)/d was approximately 50% lower than that provided by the therapeutically optimal dose in preclinical studies. CONCLUSION: rhEndostatin administered as a 20-minute daily IV injection at doses up to 240 mg/m(2) showed no significant toxicities. Evidence of clinical benefit was observed in three patients. Due to high variability between the peak and trough serum concentrations associated with the repeated short IV infusion schedule, daily serum drug levels only briefly exceeded concentrations necessary for in vitro antiangiogenic effects.
|
https://pubmed.ncbi.nlm.nih.gov/12228197/
|
[
"Clinical Trial",
"Clinical Trial, Phase I",
"Journal Article",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, P.H.S."
] |
12228197
|
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12,228,200 |
Development of biologic markers of response and assessment of antiangiogenic activity in a clinical trial of human recombinant endostatin.
|
Herbst Roy S RS, Mullani Nizar A NA, Davis Darren W DW, Hess Kenneth R KR, McConkey David J DJ, Charnsangavej Chusilp C, O'Reilly Michael S MS, Kim Hyung-Woo HW, Baker Cheryl C, Roach Jennifer J, Ellis Lee M LM, Rashid Asif A, Pluda James J, Bucana Corazon C, Madden Timothy L TL, Tran Hai T HT, Abbruzzese James L JL
|
Journal of clinical oncology : official journal of the American Society of Clinical Oncology . Vol. 20, No. 18, 2002 Sep 15
|
PURPOSE: Angiogenesis is a target for the treatment of cancer and other diseases, and its complex biology suggests that establishing the appropriate dose and schedule for antiangiogenic treatment will require extensive study. We present the initial results of a dose-finding clinical trial of recombinant human endostatin (rh-Endo) that examined potential surrogates for response to antiangiogenic therapy. PATIENTS AND METHODS: Twenty-five patients were treated with escalating doses of rh-Endo. Positron emission tomography (PET) was used to assess tumor blood flow (with [15O]H2O) and metabolism (with [18F]fluorodeoxyglucose) before the start of therapy and then every 4 weeks. To directly assess the effects of rh-Endo on endothelial cells within the tumors, biopsy specimens of tumor tissue were obtained before therapy and again at 8 weeks and evaluated for endothelial cell and tumor cell apoptosis. RESULTS: Tumor blood flow and metabolism as measured by PET scans generally decreased with increasing doses of rh-Endo; however, the effects were complex and in some analyses nonlinear. Tumor biopsy analysis revealed a significant increase in tumor cell apoptosis (P =.027) and endothelial cell apoptosis (P =.027) after 8 weeks of therapy. However, there was no statistically significant relationship between rh-Endo dose and induction of tumor cell or endothelial cell apoptosis. CONCLUSION: These initial data suggest that rh-Endo has measurable effects on tumor blood flow and metabolism and induces endothelial and tumor cell apoptosis even in the absence of demonstrable anticancer effects. Further study and validation of these biomarkers in the context of antiangiogenic therapy will be required.
|
https://pubmed.ncbi.nlm.nih.gov/12228200/
|
[
"Clinical Trial",
"Clinical Trial, Phase I",
"Journal Article",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, P.H.S."
] |
12228200
|
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12,228,199 |
Phase I study of recombinant human endostatin in patients with advanced solid tumors.
|
Herbst Roy S RS, Hess Kenneth R KR, Tran Hai T HT, Tseng Jennifer E JE, Mullani Nizar A NA, Charnsangavej Chusilp C, Madden Timothy T, Davis Darren W DW, McConkey David J DJ, O'Reilly Michael S MS, Ellis Lee M LM, Pluda James J, Hong Waun K WK, Abbruzzese James L JL
|
Journal of clinical oncology : official journal of the American Society of Clinical Oncology . Vol. 20, No. 18, 2002 Sep 15
|
PURPOSE: Endostatin, a 20-kd fragment of collagen XVIII, is a potent inhibitor of angiogenesis. We evaluated recombinant human endostatin (rh-Endo) in a phase I trial designed to assess safety, pharmacokinetics, and serum markers of angiogenesis in patients with solid tumors. PATIENTS AND METHODS: Twenty-six patients were enrolled onto a dose-finding trial of rh-Endo administered as an intravenous bolus over a 20-minute period once daily. Three patients each were treated at dose levels of 15, 30, 60, 120, 180, and 600 mg/m(2)/d, and seven patients were treated at 300 mg/m(2)/d. Treatment consisted of a minimum of two 28-day cycles. Evaluations included noninvasive imaging, pharmacokinetics, and serum biomarkers. RESULTS: Twenty-five patients were treated with rh-Endo. Treatment was well tolerated; there were no dose-limiting toxic effects. Bacteremia from frequent central line access was the most common problem. The pharmacokinetic disposition of rh-Endo was linear and best described using a two-compartmental open model. The overall mean half-life was 10.7 +/- 4.1 hours. A dose of 300 mg/m(2) achieved an area under the concentration-time curve associated with activity in preclinical models. In two patients, there was evidence of antitumor activity, but no responses were seen. Serum markers of angiogenic activity did not provide insight into rh-Endo's activity. Serum antibodies were observed against both rh-Endo and the Pichia pastoris vector, but no allergic reactions were observed. CONCLUSION: rh-Endo was safe and well tolerated. rh-Endo pharmacokinetic profiles achieved area under the concentration-time curves associated with activity in preclinical models. Evidence of minor antitumor activity was observed and further studies are indicated.
|
https://pubmed.ncbi.nlm.nih.gov/12228199/
|
[
"Clinical Trial",
"Clinical Trial, Phase I",
"Journal Article",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, P.H.S."
] |
12228199
|
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0.006080545950680971,
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] |
12,228,201 |
Selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 is generally well-tolerated and has activity in non-small-cell lung cancer and other solid tumors: results of a phase I trial.
|
Herbst Roy S RS, Maddox Anne-Marie AM, Rothenberg Mace L ML, Small Eric J EJ, Rubin Eric H EH, Baselga Jose J, Rojo Federico F, Hong Waun Ki WK, Swaisland Helen H, Averbuch Steven D SD, Ochs Judith J, LoRusso Patricia Mucci PM
|
Journal of clinical oncology : official journal of the American Society of Clinical Oncology . Vol. 20, No. 18, 2002 Sep 15
|
PURPOSE: To investigate safety, tolerability, dose-related pharmacologic properties, and pharmacodynamics of ZD1839 (gefinitib, Iressa; AstraZeneca Pharmacueticals, Wilmington, DE), an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in patients with solid tumor types known to express or highly express EGFR. METHODS: This was an open-label, phase I, dose escalation safety/tolerability trial of oral ZD1839 (150 to 1,000 mg/d), administered once daily for 28-continuous-day cycles until disease progression or undue toxicity. RESULTS: Of 71 (69 assessable for safety; 58 for efficacy) patients at seven dose levels, most had non-small-cell lung (n = 39) or head and neck (n = 18) cancer, and 68 of 71 patients received prior cancer therapy (two or more regimens in 54 patients [78%]). Diarrhea and rash, the primary dose-limiting toxicities (DLTs), occurred at 800 mg. Frequent treatment-related grade 1/2 adverse events were diarrhea (55%), asthenia (44%), and acne-like follicular rash (46%). At doses >or= 800 mg, 45% of patients required dose reductions. No increased or cumulative toxicity was observed over 250 patient-months of exposure. Pharmacokinetic analysis showed that steady-state occurred by day 7, interpatient exposure was more variable than intrapatient exposure, and variability of exposure did not change with dose. One patient experienced a partial response, but antitumor activity manifested mainly as prolonged stable disease (45% of patients >or= 3 months, 22% >or= 6 months, and 7.2% >or= 1 year). No relationship between dose, response, or duration on study was observed. CONCLUSION: Rash and diarrhea, generally mild and tolerable at doses <or= 600 mg/d, were DLTs at 800 mg/d (maximum-tolerated dose). Antitumor activity was observed at all doses. Pharmacokinetic analyses confirmed suitability of once-daily oral dosing.
|
https://pubmed.ncbi.nlm.nih.gov/12228201/
|
[
"Clinical Trial",
"Clinical Trial, Phase I",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12228201
|
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] |
12,228,203 |
Pegylated interferon alfa-2b treatment for patients with solid tumors: a phase I/II study.
|
Bukowski Ronald R, Ernstoff Marc S MS, Gore Martin E ME, Nemunaitis John J JJ, Amato Robert R, Gupta Samir K SK, Tendler Craig L CL
|
Journal of clinical oncology : official journal of the American Society of Clinical Oncology . Vol. 20, No. 18, 2002 Sep 15
|
PURPOSE: The efficacy of interferon alfa has been established in treating advanced melanoma and renal cell carcinoma (RCC) patients. We conducted a phase I/II study to determine the maximum-tolerated dose (MTD), the safety and tolerability, and the preliminary efficacy of once-weekly pegylated interferon alfa-2b (IFNalpha-2b) in patients with advanced solid tumors (primarily RCC). PATIENTS AND METHODS: To determine the MTD, 35 patients with a variety of advanced solid tumors received 0.75 to 7.5 micro g/kg/wk of pegylated IFNalpha-2b by subcutaneous injection for 12 weeks. An additional 35 previously untreated RCC patients received 6.0 and 7.5 micro g/kg/wk for up to 12 weeks. Patients with a response or stable disease after 12 weeks were eligible for the extension protocol and were treated for up to 1 year or until disease progression. RESULTS: The MTD for pegylated IFNalpha-2b at 12 weeks was 6.0 micro g/kg/wk. One year of 6.0 micro g/kg/wk was well tolerated with appropriate dose modification; no grade 3 or 4 fatigue occurred, and safety was comparable with that with nonpegylated IFNalpha-2b. The most common nonhematologic adverse events included mild to moderate nausea, anorexia, and fatigue. Six patients had grade 3 or 4 hematologic toxicity. Twenty-nine patients continued on the extension protocol. Four patients had a complete response, and five patients had a partial response. Among 44 previously untreated RCC patients, the objective response rate was 14%. Median survival for all RCC patients was 13.2 months. CONCLUSION: Pegylated IFNalpha-2b was active and well tolerated in patients with metastatic solid tumors, including RCC, at doses up to 6.0 micro g/kg/wk.
|
https://pubmed.ncbi.nlm.nih.gov/12228203/
|
[
"Clinical Trial",
"Clinical Trial, Phase I",
"Clinical Trial, Phase II",
"Journal Article",
"Multicenter Study"
] |
12228203
|
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] |
12,228,202 |
Effects of 5,6-dimethylxanthenone-4-acetic acid on human tumor microcirculation assessed by dynamic contrast-enhanced magnetic resonance imaging.
|
Galbraith Susan M SM, Rustin Gordon J S GJ, Lodge Martin A MA, Taylor N Jane NJ, Stirling J James JJ, Jameson Michael M, Thompson Paul P, Hough David D, Gumbrell Lindsey L, Padhani Anwar R AR
|
Journal of clinical oncology : official journal of the American Society of Clinical Oncology . Vol. 20, No. 18, 2002 Sep 15
|
PURPOSE: 5,6-Dimethylxanthenone-4-acetic acid (DMXAA) causes vascular shutdown in preclinical models. Dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI) studies were performed in the phase I trials to examine changes related to blood flow and permeability in tumor and muscle. PATIENTS AND METHODS: Sixteen patients treated with DMXAA from 500 to 4,900 mg/m(2) had DCE-MRI examinations before and after treatment. The maximum gradient, the maximum enhancement, and the area under the signal-intensity-time curve (AUC) over the first 90 seconds were calculated for each pixel in regions of interest (ROIs) in muscle and tumor, and the median value for each ROI was obtained. Changes after treatment were compared with 95% limits of agreement for an individual and for groups using data from our reproducibility study. RESULTS: Nine of 16 patients had significant reductions in AUC 24 hours after the first dose of DMXAA, and eight of 11 patients had reductions of up to 66% in AUC 24 hours after the last dose. Mean reductions in gradient, enhancement, and AUC were 25%, 18%, and 31%, respectively, 24 hours after the last dose, significantly greater than the 95% limits of change for a group of 11 patients. Enhancement and AUC in muscle 24 hours after the first dose were significantly reduced, but no significant changes were seen 24 hours after the last dose. CONCLUSION: DMXAA significantly reduces DCE-MRI parameters related to tumor blood flow, over a wide dose range, consistent with the reported tumor vascular targeting activity. Further clinical evaluation of DMXAA is warranted.
|
https://pubmed.ncbi.nlm.nih.gov/12228202/
|
[
"Clinical Trial",
"Clinical Trial, Phase I",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12228202
|
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12,228,205 |
Phase II multicenter trial of a weekly paclitaxel and carboplatin regimen in patients with advanced breast cancer.
|
Loesch David D, Robert Nicholas N, Asmar Lina L, Gregurich Mary Ann MA, O'Rourke Mark M, Dakhil Shaker S, Cox Edwin E
|
Journal of clinical oncology : official journal of the American Society of Clinical Oncology . Vol. 20, No. 18, 2002 Sep 15
|
PURPOSE: To determine the activity of weekly paclitaxel plus carboplatin as first-line therapy in patients with advanced breast cancer (ABC) by assessing response rate, survival, and safety. PATIENTS AND METHODS: One hundred patients with ABC received paclitaxel 135 mg/m(2) (group 1, n = 20) and carboplatin area under the concentration-time curve (AUC) of 2. Paclitaxel was subsequently reduced to 100 mg/m(2) (group 2, n = 80) because of toxicity. The median age was 58.5 years, and most patients had an Eastern Cooperative Oncology Group performance status of <or= 2. Estrogen and progesterone receptor status were evenly distributed among both groups. Sixty-one patients received prior chemotherapy, 37 (61%) of whom received prior doxorubicin. Among 47 patients who received prior hormonal therapy, 43 received tamoxifen. RESULTS: The overall response rate (ORR) among 95 assessable patients was 62%, including 8% complete responses and 54% partial responses. The median time to response was 1.8 months, and the median duration of response was 13.3 months. The median time to progression was 4.8 months. The median survival was 16 months. Neutropenia and leukopenia were the most common grade 3 and 4 toxicities. In group 1, neutropenia (50%) and leukopenia (35%) necessitated dose reductions for 50% of patients during the first three cycles, prompting the reduction in paclitaxel dose to 100 mg/m(2). Grade 3 and 4 nonhematologic toxicities for all patients included peripheral neuropathy (11%), infection (6%), anemia (5%), weakness (6%), and paresthesia (3%). CONCLUSION: The 62% ORR achieved with weekly paclitaxel plus carboplatin is among the highest achieved with chemotherapy for ABC. This high response rate and the lack of cardiotoxicity suggest that the regimen should be considered as a nonanthracycline regimen for future adjuvant therapy.
|
https://pubmed.ncbi.nlm.nih.gov/12228205/
|
[
"Clinical Trial",
"Clinical Trial, Phase II",
"Journal Article",
"Multicenter Study",
"Research Support, Non-U.S. Gov't"
] |
12228205
|
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] |
12,228,207 |
Treatment of extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue type with cladribine: a phase II study.
|
Jäger Gerald G, Neumeister Peter P, Brezinschek Ruth R, Hinterleitner Thomas T, Fiebiger Wolfgang W, Penz Melitta M, Neumann Hans J HJ, Mlineritsch Brigitte B, DeSantis Maria M, Quehenberger Franz F, Chott Andreas A, Beham-Schmid Christine C, Höfler Gerald G, Linkesch Werner W, Raderer Markus M
|
Journal of clinical oncology : official journal of the American Society of Clinical Oncology . Vol. 20, No. 18, 2002 Sep 15
|
PURPOSE: As chemotherapy has not been extensively studied in patients with lymphoma of the mucosa-associated lymphoid tissue (MALT), we initiated a prospective study to evaluate the activity of the nucleoside analog cladribine (2-chlorodeoxyadenosine [2-CdA]) in this disease. PATIENTS AND METHODS: Patients with histologically verified MALT-type lymphoma were enrolled. 2-CdA was administered at a dose of 0.12 mg/kg body weight on 5 consecutive days, as a 2-hour infusion. Cycles were repeated every 4 weeks for a maximum of six cycles. RESULTS: Nineteen patients with gastric and seven patients with extragastric MALT lymphoma were enrolled. All patients were chemotherapy-naive, and two had been locally irradiated before systemic relapse of the lymphoma. A total of 102 cycles was administered to our patients (median number of cycles per patient, four). All 25 assessable patients responded to treatment: 21 patients (84%) achieved complete remission (CR) and four patients achieved partial remission. All patients (100%) with gastric presentation, but only three patients (43%) with extragastric presentation, achieved CR. Toxicities were moderate and mainly hematologic and required dose reduction and/or premature discontinuation of therapy in only three cases. Two patients died from vascular events, one shortly after the first cycle because of myocardial infarction and the other from stroke 3 months after the second course. Three patients relapsed after 13, 18, and 22 months and one patient showed progressive disease after 15 months. At present, 24 patients are alive at a median follow-up time of 32 months. CONCLUSION: Our data demonstrate that 2-CdA is highly effective in inducing CR in 84% of patients with MALT-type lymphoma.
|
https://pubmed.ncbi.nlm.nih.gov/12228207/
|
[
"Clinical Trial",
"Clinical Trial, Phase II",
"Journal Article"
] |
12228207
|
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12,228,208 |
Therapy-related myeloid leukemias are observed in patients with chronic lymphocytic leukemia after treatment with fludarabine and chlorambucil: results of an intergroup study, cancer and leukemia group B 9011.
|
Morrison Vicki A VA, Rai Kanti R KR, Peterson Bercedis L BL, Kolitz Jonathan E JE, Elias Laurence L, Appelbaum Frederick R FR, Hines John D JD, Shepherd Lois L, Larson Richard A RA, Schiffer Charles A CA
|
Journal of clinical oncology : official journal of the American Society of Clinical Oncology . Vol. 20, No. 18, 2002 Sep 15
|
PURPOSE: Patients with chronic lymphocytic leukemia (CLL) may have disease transformation to non-Hodgkin's lymphoma or prolymphocytic leukemia; however, development of therapy-related acute myeloid leukemia (t-AML) is unusual. A series of patients enrolled onto an intergroup CLL trial were examined for this complication. PATIENTS AND METHODS: A total of 544 previously untreated B-cell CLL patients were enrolled onto a randomized intergroup study comparing treatment with chlorambucil, fludarabine, or fludarabine plus chlorambucil. Case report forms from 521 patients were reviewed for t-AML. RESULTS: With a median follow-up of 4.2 years, six patients (1.2%) to date have developed therapy-related myelodysplastic syndrome (t-MDS; n = 3), t-AML (n = 2), or t-MDS evolving to t-AML (n = 1), from 27 to 53 months (median, 34 months) after study entry. This included five (3.5%) of 142 patients treated with fludarabine plus chlorambucil and one (0.5%) of 188 receiving fludarabine; no chlorambucil-treated patients developed t-MDS or t-AML (P =.007). At study entry, the median age among these six patients was 56 years (range, 44 to 72 years); three were male; the CLL Rai stage was I/II (n = 4) or III/IV (n = 2). Response to CLL therapy was complete (n = 4) or partial remission (n = 1) and stable disease (n = 1). Marrow cytogenetics, obtained in three of six cases at diagnosis of t-MDS or t-AML, were complex, with abnormalities in either or both chromosomes 5 and 7. Other abnormalities involved chromosomes X, 1, 8, 12, 17, and 19. Median survival after diagnosis of t-MDS/AML was 3.5 months (range, 0.5 to 10.1 months). CONCLUSION: Our findings raise the possibility that alkylator-purine analog combination therapy may increase the risk of therapy-related myeloid malignancies, which is of particular relevance with regard to ongoing trials using these combination therapies.
|
https://pubmed.ncbi.nlm.nih.gov/12228208/
|
[
"Clinical Trial",
"Controlled Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, P.H.S."
] |
12228208
|
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] |
12,228,210 |
Alemtuzumab in previously treated chronic lymphocytic leukemia patients who also had received fludarabine.
|
Rai K R KR, Freter C E CE, Mercier R J RJ, Cooper M R MR, Mitchell B S BS, Stadtmauer E A EA, Santábarbara P P, Wacker B B, Brettman L L
|
Journal of clinical oncology : official journal of the American Society of Clinical Oncology . Vol. 20, No. 18, 2002 Sep 15
|
PURPOSE: This phase II pilot study determined the efficacy and safety of alemtuzumab (Campath-1H; Burroughs Wellcome, United Kingdom) in patients with chronic lymphocytic leukemia (CLL), all of whom had previously received fludarabine and other chemotherapy regimens. PATIENTS AND METHODS: Twenty-four patients were treated with intravenous alemtuzumab at six centers in the United States. The target dose of 30 mg over 2 hours, three times weekly, was administered for up to 16 weeks. Responses were evaluated by an independent panel of experts using 1996 National Cancer Institute-sponsored Working Group criteria. Safety assessments included analysis of lymphocyte subpopulations. Antimicrobial prophylaxis was not mandatory. RESULTS: Eight patients (33%) achieved a major response (all partial remissions), with a median time to response of 3.9 months (range, 1.6 to 5.3 months). The median duration of response was 15.4 months (range, 4.6 to >or= 38.0 months), the median time to disease progression was 19.6 months (range, 7.7 to >or= 42.0 months), and the median survival time was 35.8 months (range, 8.8 to >or= 47.1 months). Acute infusion-related events, mainly grades 1 and 2, were most common and most severe in the first week. Ten patients (eight nonresponders and two responders) experienced major infections on-study. Pneumocystis carinii pneumonia was reported in two patients on-study; neither had received prophylaxis. Median CD4+ and CD8+ counts decreased and then began to increase by the end of the study, with further recovery by 1-month follow-up. One of 53 samples obtained from 10 patients had a low titer of alemtuzumab antibodies. CONCLUSION: Alemtuzumab has significant activity in poor-prognosis, fludarabine-treated CLL patients. However, because of a relatively high incidence of opportunistic infections accompanying profound lymphopenia, future protocols should include mandatory prophylaxis.
|
https://pubmed.ncbi.nlm.nih.gov/12228210/
|
[
"Clinical Trial",
"Clinical Trial, Phase II",
"Journal Article",
"Multicenter Study",
"Research Support, Non-U.S. Gov't"
] |
12228210
|
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12,228,773 |
The Pediatric Randomized Carvedilol Trial in Children with Heart Failure: rationale and design.
|
Shaddy Robert E RE, Curtin E Leigh EL, Sower Brett B, Tani Lloyd Y LY, Burr Jeri J, LaSalle Bernard B, Boucek Mark M MM, Mahony Lynn L, Hsu Daphne T DT, Pahl Elfriede E, Burch Grant H GH, Schlencker-Herceg Rozsa R
|
American heart journal . Vol. 144, No. 3, 2002 Sep
|
BACKGROUND: Carvedilol is a medication with both beta-receptor and alpha-receptor blocking properties that has been approved for the treatment of heart failure in adults. Little is known about its safety, efficacy, pharmacokinetics, and dosing profile in children. METHODS: The primary objective of this study is to evaluate the efficacy of carvedilol administered twice daily for 8 months in terms of its effect compared with placebo on a composite measure of clinical outcomes in children with symptomatic systemic ventricular systolic dysfunction and heart failure. The secondary objectives are to determine the effect of carvedilol on individual components of a composite of clinical outcomes (hospitalizations for worsening heart failure, all-cause mortality and cardiovascular hospitalizations, all cause mortality, heart failure symptoms, and patient and physician global assessment); determine the effect of carvedilol on echocardiographic indices of ventricular function and remodeling; characterize the pharmacokinetics of carvedilol in pediatric patients with heart failure; characterize the effects carvedilol on neurohormonal systems; and provide data for the selection of an optimal titration schedule and daily dose of carvedilol in children with heart failure. This study will enroll 150 children between birth and 17 years of age with chronic symptomatic heart failure caused by systemic ventricular systolic dysfunction. CONCLUSION: This study will determine whether carvedilol improves symptoms in children with heart failure as a result of systemic ventricular systolic dysfunction. The study also will provide information on echocardiographic changes of ventricular performance and neurohormonal levels in children with heart failure before and after treatment with carvedilol, in addition to pharmacokinetics of carvedilol in children.
|
https://pubmed.ncbi.nlm.nih.gov/12228773/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12228773
|
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] |
12,228,778 |
Overview of randomized trials of antiarrhythmic drugs and devices for the prevention of sudden cardiac death.
|
Heidenreich Paul A PA, Keeffe Brian B, McDonald Kathryn M KM, Hlatky Mark A MA
|
American heart journal . Vol. 144, No. 3, 2002 Sep
|
BACKGROUND: Sudden cardiac death is a prominent feature of the natural history of heart disease. The efficacy of antiarrhythmic drugs and devices in preventing sudden death and reducing total mortality is uncertain. METHODS: We reviewed randomized trials and quantitative overviews of type I and type III antiarrhythmic drugs. We also reviewed the randomized trials of implantable cardioverter defibrillators and combined these outcomes in a quantitative overview. RESULTS: Randomized trials of type I antiarrhythmic agents used as secondary prevention after myocardial infarction show an overall 21% increase in mortality rate. Randomized trials of amiodarone suggest a 13% to 19% decrease in mortality rate, and sotalol has been effective in several small trials. Trials of pure type III agents, however, have shown no mortality benefit. An overview of implantable defibrillator trials shows a 24% reduction in mortality rate (CI 15%-33%) compared with alternative therapy, most often amiodarone. CONCLUSION: Amiodarone is effective in reducing the total mortality rate by 13% to 19%, and the implantable defibrillator reduces the mortality rate by a further 24%.
|
https://pubmed.ncbi.nlm.nih.gov/12228778/
|
[
"Comparative Study",
"Journal Article",
"Meta-Analysis",
"Research Support, U.S. Gov't, Non-P.H.S.",
"Research Support, U.S. Gov't, P.H.S."
] |
12228778
|
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12,228,782 |
How long is too long? Association of time delay to successful reperfusion and ventricular function outcome in acute myocardial infarction: the case for thrombolytic therapy before planned angioplasty for acute myocardial infarction.
|
Lundergan Conor F CF, Reiner Jonathan S JS, Ross Allan M AM
|
American heart journal . Vol. 144, No. 3, 2002 Sep
|
OBJECTIVES: The purpose of this study was to quantify the effect of time delays to reperfusion on ventricular function after myocardial infarction. This allows one to identify a group of patients in whom a strategy using antecedent pharmacologic reperfusion therapy before planned direct angioplasty may offer significant benefit. BACKGROUND: Direct angioplasty for myocardial infarction is associated with a high rate of successful reperfusion compared with pharmacologic reperfusion. However, there is an inherent time delay to treatment with angioplasty compared with pharmacologic therapy. There currently are insufficient data to determine the consequences of incremental time delays to reperfusion on ventricular function. METHODS: We determined, by logistic regression analysis, the probability of observing a decrement in postmyocardial infarction ventricular function as a function of incremental time delays to reperfusion. RESULTS: Time delays of 30, 60, 90, or 120 minutes to reperfusion increased the likelihood of a worse ventricular function outcome by 1.1-, 1.3-, 1.5-, and 1.7-fold, respectively (P <.02). The upper 95% confidence limits around these odds ratios are as high as 1.3 or 2.7 for 30- and 120-minute delays, respectively. Time from symptom onset to patency remained a significant determinant of ventricular function after adjustment for clinical and procedural factors. CONCLUSIONS: Delay in time to reperfusion, measured in minutes, results in significant loss of ventricular function after myocardial infarction. Interventional strategies designed for treatment of myocardial infarction when "door-to-balloon" time is expected to exceed 60 minutes should strongly consider incorporation of pharmacologic reperfusion therapy into the therapeutic paradigm.
|
https://pubmed.ncbi.nlm.nih.gov/12228782/
|
[
"Clinical Trial",
"Journal Article",
"Multicenter Study",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12228782
|
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] |
12,228,785 |
Prognostic value of baseline electrophysiology studies in patients with sustained ventricular tachyarrhythmia: the Antiarrhythmics Versus Implantable Defibrillators (AVID) trial.
|
Brodsky Michael A MA, Mitchell L Brent LB, Halperin Blair D BD, Raitt Merritt H MH, Hallstrom Alfred P AP,
|
American heart journal . Vol. 144, No. 3, 2002 Sep
|
OBJECTIVES: We sought to determine the value of electrophysiology (EP) testing in patients with ventricular fibrillation (VF), ventricular tachycardia (VT) with syncope, or sustained VT in the setting of left ventricular dysfunction. BACKGROUND: Traditionally, EP testing is part of the workup of patients with sustained VT or VF. Recently, some have suggested that EP testing is unnecessary in these patients, many of whom are likely to receive an implantable cardioverter-defibrillator (ICD). METHODS: Within a multicenter trial (Antiarrhythmics Versus Implantable Defibrillators) designed to evaluate whether drugs or ICD resulted in a better outcome, data were analyzed regarding EP testing. Although this testing was not required, it was performed in >50% of patients. Information regarding the results of EP testing was correlated to baseline clinical characteristics and outcome. RESULTS: Of 572 patients subjected to an EP test, 384 (67%) had inducible sustained VT or VF. Inducible patients were more likely to have coronary artery disease, previous infarction, and VT as their index arrhythmic event. Inducibility of VT or VF did not predict death or recurrent VT or VF. CONCLUSIONS: Information derived from EP testing in this patient population, particularly those with VF, is of limited value and may not be worth the risks and costs of the procedure, particularly in those patients likely to receive an ICD.
|
https://pubmed.ncbi.nlm.nih.gov/12228785/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Multicenter Study",
"Randomized Controlled Trial"
] |
12228785
|
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12,228,784 |
Randomized double-blind safety study of enoxaparin versus unfractionated heparin in patients with non-ST-segment elevation acute coronary syndromes treated with tirofiban and aspirin: the ACUTE II study. The Antithrombotic Combination Using Tirofiban and Enoxaparin.
|
Cohen Marc M, Théroux Pierre P, Borzak Steven S, Frey Martin J MJ, White Harvey D HD, Van Mieghem W W, Senatore Fred F, Lis Joy J, Mukherjee Robin R, Harris Kathy K, Bigonzi Frederique F,
|
American heart journal . Vol. 144, No. 3, 2002 Sep
|
BACKGROUND: In comparison with treatment with unfractionated heparin (UFH) and aspirin (ASA), both tirofiban administered with UFH and ASA, and enoxaparin plus ASA have shown superiority in reducing cardiac ischemic events in patients with unstable angina and non-ST-segment elevation myocardial infarction. Replacing UFH with enoxaparin when tirofiban is administered to patients may offer further therapeutic benefit, but could also increase bleeding. OBJECTIVE: Our objective was to provide estimates of the frequency of bleeding complications, as defined by means of the Thrombolysis In Myocardial Infarction(TIMI) group, and collect data on clinical efficacy of the combination of tirofiban with enoxaparin plus ASA. METHODS: Five hundred twenty-five patients with UA/NSTEMI were treated with tirofiban coadministered with ASA and randomized to receive either UFH (n = 210) or enoxaparin (n = 315). Therapy was administered for 24 to 96 hours. Bleeding incidences were assessed until 24 hours after trial therapy was discontinued; other clinical outcomes were assessed for as long as 30 days. RESULTS: The total bleeding rate (TIMI major + minor + loss-no-site) for the UFH group versus the enoxaparin group was 4.8% vs 3.5% (odds ratio [OR] 1.4, CI 0.6-3.4). The TIMI major and minor bleeding rates for the UFH versus the enoxaparin groups were 1.0% versus 0.3% (OR 3.0, CI 0.3-33.8) and 4.3% versus 2.5% (OR 1.7, CI 0.7-4.6). There was an increase in nuisance cutaneous and oral bleeds (<50 mL of blood loss) in the enoxaparin group. Death or myocardial infarction occurred with similar frequency in the 2 groups (9.0% vs 9.2%). However, refractory ischemia requiring urgent revascularization and rehospitalization because of unstable angina occurred more frequently in the UFH group (4.3% vs 0.6% and 7.1% vs 1.6%, respectively). CONCLUSIONS: Combination therapy with tirofiban plus enoxaparin appears safe, relative to therapy with tirofiban plus UFH.
|
https://pubmed.ncbi.nlm.nih.gov/12228784/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12228784
|
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12,228,789 |
Effects of sibutramine on ventricular dimensions and heart valves in obese patients during weight reduction.
|
Zannad Faiez F, Gille Bertrand B, Grentzinger Alain A, Bruntz Jean-François JF, Hammadi Mokrane M, Boivin Jean-Marc JM, Hanotin Corinne C, Igau Bruno B, Drouin Pierre P
|
American heart journal . Vol. 144, No. 3, 2002 Sep
|
BACKGROUND: Obesity enhances hemodynamic alterations that predispose to a subsequent increase in left ventricular (LV) wall stress leading to LV hypertrophy. In obese subjects, weight reduction regresses LV mass (LVM), regardless of blood pressure. Sibutramine can increase blood pressure and heart rate, which may attenuate the reductions in LVM associated with weight loss. METHODS: Outpatients (n = 184, age 18-65 y, body mass index > or =30 to <40 kg/m2) were randomly assigned to 6 months of once daily double-blind treatment with sibutramine 10 mg or 20 mg, or placebo. LV dimensions, status and function of the valves, weight loss, blood pressure, heart rate, and electrocardiogram were assessed. RESULTS: For end point data sets, the mean +/- SD LVM index (LVM/height) changes were -3.0 +/- 11.9 g/m for placebo (n = 56), -4.4 +/- 10.7 g/m for sibutramine 10 mg (n = 61), and -4.3 +/- 10.9 g/m for sibutramine 20 mg (n = 56). The reductions observed in the sibutramine groups were statistically significant compared with baseline (P <.01), but pairwise comparison results with placebo were not statistically significant. There was no difference in overall status of the cardiac valves. A statistically significant greater weight loss was found in patients on both doses of sibutramine compared with placebo (P <.001). No statistically significant differences between the groups were observed in respect to blood pressure and electrocardiographic intervals, but a statistically significant increase in pulse rate (7 beats/min) was noted for patients with sibutramine treatment. CONCLUSION: A 6-month treatment with sibutramine does not affect ventricular dimensions, heart valves, and electrocardiogram variables.
|
https://pubmed.ncbi.nlm.nih.gov/12228789/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12228789
|
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12,228,819 |
Randomized, placebo-controlled trial of atovaquone/proguanil for the prevention of Plasmodium falciparum or Plasmodium vivax malaria among migrants to Papua, Indonesia.
|
Ling Judith J, Baird J Kevin JK, Fryauff David J DJ, Sismadi Priyanto P, Bangs Michael J MJ, Lacy Mark M, Barcus Mazie J MJ, Gramzinski Robert R, Maguire Jason D JD, Kumusumangsih Marti M, Miller Gerri B GB, Jones Trevor R TR, Chulay Jeffrey D JD, Hoffman Stephen L SL,
|
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America . Vol. 35, No. 7, 2002 Oct 01
|
The increasing prevalence of resistance to antimalarial drugs reduces options for malaria prophylaxis. Atovaquone/proguanil (Malarone; GlaxoSmithKline) has been >95% effective in preventing Plasmodium falciparum malaria in lifelong residents of areas of holoendemicity, but data from persons without clinical immunity or who are at risk for Plasmodium vivax malaria have not been described. We conducted a randomized, double-blinded study involving 297 people from areas of nonendemicity in Indonesia who migrated to Papua (where malaria is endemic) < or =26 months before the study period. Subjects received prophylaxis with 1 Malarone tablet (250 mg of atovaquone and 100 mg of proguanil hydrochloride; n=148) or placebo (n=149) per day for 20 weeks. Hematologic and clinical chemistry values did not change significantly. The protective efficacy of atovaquone/proguanil was 84% (95% confidence interval [CI], 44%-95%) for P. vivax malaria, 96% (95% CI, 72%-99%) for P. falciparum malaria, and 93% (95% CI, 77%-98%) overall. Atovaquone/proguanil was well tolerated, safe, and effective for the prevention of drug-resistant P. vivax and P. falciparum malaria in individuals without prior malaria exposure who migrated to Papua, Indonesia.
|
https://pubmed.ncbi.nlm.nih.gov/12228819/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, Non-P.H.S."
] |
12228819
|
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] |
12,228,843 |
The SCOPE trial. Study on Cognition and Prognosis in the Elderly.
|
Sever Peter P
|
Journal of the renin-angiotensin-aldosterone system : JRAAS . Vol. 3, No. 2, 2002 Jun
|
The Study on Cognition and Prognosis in the Elderly (SCOPE) was designed to provide outcome data on cardiovascular endpoints and cognitive function in 4500 elderly hypertensive patients randomised to the angiotensin receptor blocker, candesartan, or to placebo and followed up for 4.5 years. The primary endpoint of combined cardiovascular mortality, non-fatal myocardial infarction and non-fatal stroke was not significantly reduced by active treatment (relative risk reduction 11%, p=0.19). There was also no significant difference in the decline of cognitive function between the two treatment arms. Active treatment of the placebo group (mainly hydrochlorothiazide) reduced the blood pressure differences between the treatment arms to only 3.2/1.6 mmHg, thus markedly reducing the overall power of the study. In a number of non-prespecified subgroup analyses, advantages of candesartan over placebo were reported.
|
https://pubmed.ncbi.nlm.nih.gov/12228843/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Review"
] |
12228843
|
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] |
12,228,853 |
Lack of rapid aldosterone effects on forearm resistance vasculature in health.
|
Gunaruwan Prasad P, Schmitt Matthias M, Taylor Justin J, Lee Leong L, Struthers Allan A, Frenneaux Michael M
|
Journal of the renin-angiotensin-aldosterone system : JRAAS . Vol. 3, No. 2, 2002 Jun
|
OBJECTIVES: Systemic infusions of aldosterone cause an acute increase in systemic vascular resistance (SVR) in healthy subjects. It is not clear whether this is due to a direct effect on the vasculature or the result of increased sympathetic tone. We investigated the short-term effects of locally infused aldosterone on the forearm resistance bed. METHODS: In this dose response study, we assessed the effects of incremental doses (10, 50, 100 ng/minute) of intrabrachial aldosterone on forearm blood flow (FBF), using conventional strain gauge plethysmography. Arterial blood pressure was monitored continuously, using finger photo- plethysmography. Forearm vascular resistance (FVR) was calculated. FBF and FVR were also measured in the non-infused arm. Changes in FBF and FVR in the infused arm were corrected for those occurring in the control arm. RESULTS: Plasma aldosterone levels in the venous effluent of the infused arm increased in a dose-dependent fashion, from 113.3+/-17.9 pg/ml at baseline to 297.8+/-51.8 pg/ml at 10 ng/minute (p=<0.01), 743.9+/-105.9 pg/ml at 50 ng/min (p=<0.001 vs. baseline) and 1230.6+/-73.7 pg/ml at 100 ng/min (p=<0.0005 vs. baseline). Plasma concentrations of aldosterone in the control arm did not change significantly vs. baseline. The corrected FBF (+4.1+/-10.3%) and corrected FVR (+4.3+/-11.3%) did not change significantly even at peak infusion rates. CONCLUSIONS: Local intra-arterial infusion of aldosterone had no acute effect on forearm resistance vessels in healthy male volunteers.
|
https://pubmed.ncbi.nlm.nih.gov/12228853/
|
[
"Clinical Trial",
"Journal Article"
] |
12228853
|
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] |
12,228,852 |
Comparison of the effects of antihypertensive treatment with angiotensin II blockade and beta-blockade on carotid wall structure and haemodynamics: protocol and baseline demographics.
|
Ariff Ben B, Stanton Alice A, Barratt Dean D, Augst Alex A, Glor Fadi F, Poulter Neil N, Sever Peter P, Xu Yun Y, Hughes Alun A, Thom Simon A Mc G SA
|
Journal of the renin-angiotensin-aldosterone system : JRAAS . Vol. 3, No. 2, 2002 Jun
|
Several systemic factors have been shown to contribute to the acceleration of large vessel atheroma. Correction of these factors leads to a reduction in the progression of plaque formation and associated arterial wall thickness. Atheroma remains, however, a focal disease, developing at characteristic sites within the arterial tree. These sites are typically at areas of vessel branching or marked curvature, and correspond to regions of high tensile stress and low sheer stress, leading to the hypothesis that local haemodynamic factors and vessel wall mechanics potentiate the focal development of atheroma. Current assessment of vascular haemodynamics suffers from an inability to handle complex flow, and does not allow accurate determination of locally varying flow, and shear stress patterns. The application of computational fluid dynamic (CFD) flow simulation techniques to ultrasound and local pressure data, however, allows a comprehensive, non-invasive appraisal of haemodynamic flow parameters to be performed. The Candesartan cilexetil and Atenolol Carotid Haemodynamic Endpoint Trial (CACHET) study compares the effects of two antihypertensive regimens, one b-blocker-based, the other angiotensin receptor blocker based, on carotid intima-media thickness. The collection of ultrasound and pressure data on each subject provides a unique opportunity to apply these data to the CFD model to study the effects of these antihypertensive regimens on local fluid dynamics. This will lead to a greater understanding of the relationship of these factors to atheroma formation and regression.
|
https://pubmed.ncbi.nlm.nih.gov/12228852/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12228852
|
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] |
12,228,880 |
Statistical issues in the assessment of the evidence for an interaction between factors in epilepsy trials.
|
Williamson Paula R PR, Clough Helen E HE, Hutton Jane L JL, Marson Anthony G AG, Chadwick David W DW
|
Statistics in medicine . Vol. 21, No. 18, 2002 Sep 30
|
We examine the common clinical belief that there is an interaction between epilepsy type and the two standard anti-epileptic drugs, valproate and carbamazepine, using data from several randomized clinical trials. Epilepsy type is not always easy to define, and three possible reclassifications are investigated to see whether misclassification of epilepsy type within the trials has potentially masked such an interaction. Regression modelling is employed to investigate whether heterogeneity between trial results can be explained by patient factors. Our work suggests that uncertainty in epilepsy type classification should be recognized in future studies. We also generate the hypothesis that the interaction of drug effect with age may reflect the perceived interaction with epilepsy type. We suggest that in any context where misclassification is likely, it is worth considering the use of an explicit 'unclassified' group, and investigating whether additional covariates can answer the substantive question.
|
https://pubmed.ncbi.nlm.nih.gov/12228880/
|
[
"Journal Article",
"Meta-Analysis",
"Research Support, Non-U.S. Gov't"
] |
12228880
|
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] |
12,228,873 |
Coping and health-related quality of life in men with prostate cancer randomly assigned to hormonal medication or close monitoring.
|
Green Heather J HJ, Pakenham Kenneth I KI, Headley Betty C BC, Gardiner Robert A RA
|
Psycho-oncology . Vol. 11, No. 5
|
Prostatic carcinoma and its treatment have been associated with adverse effects on health-related quality of life (HRQoL). Individual differences in appraisal and coping have been suggested to mediate these HRQoL outcomes. A randomized trial of 65 men with non-localized prostate cancer compared several treatments and tested associations between appraisal, coping, and HRQoL. These patients, and 16 community volunteers matched for age and general health, undertook psychosocial assessments before treatment and after 6 months of treatment. Compared with baseline assessments, men on hormonal treatments reported impaired sexual function. Groups did not differ on emotional distress, existential satisfaction, subjective cognitive function, physical symptoms, or social and role functioning. For individuals, hormonal treatments were more frequently associated with decreased sexual, social and role functioning, but were also associated with improved physical symptoms. In hierarchical regression analysis, HRQoL was lower for men who had more comorbid illnesses, a history of neurological dysfunction, higher threat appraisals, or higher use of coping strategies at baseline. These results showed that pharmacological hormonal ablation for prostate cancer can improve or decrease HRQoL in different domains. HRQoL in men with prostate cancer was associated more strongly with appraisal and coping than with medical variables.
|
https://pubmed.ncbi.nlm.nih.gov/12228873/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12228873
|
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] |
12,228,945 |
Is disability underreported following work injury?
|
Evanoff Bradley B, Abedin Sakena S, Grayson Deborah D, Dale Ann Marie AM, Wolf Laurie L, Bohr Paula P
|
Journal of occupational rehabilitation . Vol. 12, No. 3, 2002 Sep
|
Existing national data may underreport the full burden of occupational injuries and illnesses. This study sought to provide more complete reporting and to assess disability that persisted following return to work. Workers (n = 205) with a musculoskeletal injury resulting in 5 or more days of lost time or restricted duty were recruited from three employers. Data on work status and functional limitations were derived from multiple sources including administrative records, medical records, and patient interviews at baseline and 6 months. Results indicate that many workers reported continuing difficulties functioning at work following return to full duty. Measures of health-related quality of life improved over 6 months, but bodily pain and physical functioning scores remained lower than expected based on national averages. Sixteen percent of workers were reinjured within a year following initial injury. Following return to work, many workers experienced reinjury or reported persistent limitations in function 6 months following injury. Based on study findings the conclusion is drawn that OSHA logs may provide accurate measures of initial episodes of time loss from work but may under-represent the full magnitude of lost time following work injury.
|
https://pubmed.ncbi.nlm.nih.gov/12228945/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, P.H.S."
] |
12228945
|
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] |
12,229,073 |
Tracking procedures for locating high-risk youth.
|
McCuller William J WJ, Sussman Steve S, Holiday Karen K, Craig Sande S, Dent Clyde W CW
|
Evaluation & the health professions . Vol. 25, No. 3, 2002 Sep
|
Few published works are available that provide a comprehensive description of tracking procedures. This article describes the data collection tracking protocol that was used in Project Towards No Drug Abuse (Project TND), to follow high-risk youth over a 5 1/2 year period. Youth were followed from 1994 through 2000. A total of 35% of these youth were assessed 5 1/2 years later. Collapsing across the last two waves, 46% of these youth were followed an average of 5 years later. These procedures may be helpful in tracking highly mobile youth.
|
https://pubmed.ncbi.nlm.nih.gov/12229073/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, U.S. Gov't, P.H.S."
] |
12229073
|
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] |
12,229,939 |
Overall mortality in the program on the surgical control of the hyperlipidemias.
|
Buchwald Henry H, Williams Stanley E SE, Matts John P JP, Nguyen Phuong A PA, Boen James R JR
|
Journal of the American College of Surgeons . Vol. 195, No. 3, 2002 Sep
|
BACKGROUND: The Program on the Surgical Control of the Hyperlipidemias (POSCH), a secondary intervention trial, was the only lipid/atherosclerosis randomized clinical trial that used a surgical modality--partial ileal bypass. POSCH provided solid evidence for the clinical and arteriographic benefits of lipid profile normalization. Few longterm followup reports have been published in this field. This report concerns overall mortality, the primary endpoint of POSCH, with a mean followup of 18 years (range 15.5 to 23.0 years). STUDY DESIGN: Overall mortality data were compiled from reports to the POSCH clinics, followup telephone calls, death certificates, and the US National Death Index. RESULTS: There were 144 deaths in the control group (n = 417) and 120 deaths in the intervention group (n = 421), using intent-to-treat analysis. The risk reduction in the intervention group was 0.201 (20%); the risk ratio was 0.799, or 0.8 (95% confidence intervals, 0.628 to 1.018, p = 0.07). The proportion of patients alive was 65.7% in the control group and 72.0% in the intervention group, for a difference of 6.3% in the intervention group (p = 0.05). Kaplan-Meier survival analysis (p = 0.046) and disease-free intervals analysis at 70% survival (p < 0.001) were confirmatory. The gain in life expectancy in the intervention group was 2.7 years. CONCLUSIONS: Longterm followup POSCH data demonstrate that lipid profile normalization will decrease overall mortality and will maintain a persistent and constant increase in life expectancy.
|
https://pubmed.ncbi.nlm.nih.gov/12229939/
|
[
"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."
] |
12229939
|
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] |
12,229,970 |
Constitutive expression of inducible nitric oxide synthase in the normal human colonic epithelium.
|
Perner A A, Andresen L L, Normark M M, Rask-Madsen J J
|
Scandinavian journal of gastroenterology . Vol. 37, No. 8, 2002 Aug
|
BACKGROUND: Inducible nitric oxide synthase (iNOS) in the human colon is considered expressed only in inflammatory states such as ulcerative or collagenous colitis. As subtle iNOS labelling was previously observed in some colonic mucosal biopsies from a heterogeneous group of controls with non-inflamed bowel, we studied whether bowel preparation with bisacodyl or polyethylene glycol prior to sigmoidoscopy might induce iNOS expression. METHODS: Ten healthy, non-smoking male subjects were investigated. Mucosal biopsies were taken from the sigmoid colon prior to bowel preparation and again 12 h after rectal administration of bisacodyl or polyethylene glycol in randomized order. Expression of iNOS protein was quantified by Western blot analysis and localized by immunohistochemistry. RESULTS: iNOS was expressed in the colonic mucosal biopsies from all subjects and localized in the epithelial cells, particularly at the luminal border of the epithelial cells and more pronounced in the crypt epithelium. The expression of iNOS was unaffected by bowel preparation with bisacodyl or polyethylene glycol. CONCLUSIONS: iNOS is constitutively expressed in the normal colonic epithelium. The results suggest that synthesis of iNOS protein is unaffected by bowel preparation with the secretagogue laxative, bisacodyl, or polyethylene glycol.
|
https://pubmed.ncbi.nlm.nih.gov/12229970/
|
[
"Clinical Trial",
"Controlled Clinical Trial",
"Journal Article"
] |
12229970
|
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] |
12,229,974 |
Changes in bile acid composition and effect on cytolytic activity of fecal water by ursodeoxycholic acid administration: a placebo-controlled cross-over intervention trial in healthy volunteers.
|
van Gorkom B A P BA, van der Meer R R, Boersma-van Ek W W, Termont D S M L DS, de Vries E G E EG, Kleibeuker J H JH
|
Scandinavian journal of gastroenterology . Vol. 37, No. 8, 2002 Aug
|
BACKGROUND: Ursodeoxycholic acid (UDCA) has been shown to affect membrane-damaging effects of bile acids in vitro and fecal bile acid composition in rats. This study evaluates the effect of UDCA on fecal bile acid composition and on cytolytic activity of fecal water in man to clarify the potential chemopreventive role of UDCA for colorectal cancer. METHODS: In this placebo-controlled crossover intervention trial, the effect of 900 mg/day UDCA orally in 15 healthy volunteers was studied. At the end of each 4-week period, 72 h feces were collected. Total and individual bile acids in feces were determined by gas chromatography and soluble bile acids were analyzed by high-performance liquid chromatography. Cytolytic activity of fecal water was measured using an erythrocyte lysis assay. RESULTS: In feces, the percentages of primary bile acids-cholic acid (CA) and chenodeoxycholic acid (CDCA)-and of secondary bile acid-deoxycholic acid (DCA) - decreased after supplementation with UDCA, whereas those of UDCA and LCA increased from 2.7 +/- 0.4% to 23.7 +/- 2.6%, P < 0.0001 and from 26.2 +/- 1.2% to 49.4 +/- 1.8%, P < 0.0001 respectively. The concentrations of these two bile acids in fecal water also increased after UDCA administration from 7.8 +/- 1.9 micromol/l to 47.0 +/- 6.7 micromol/l (UDCA), P < 0.0001 and from 2.5 +/- 0.6 micromol/l to 18.3 +/- 4.1 micromol/l (LCA), P < 0.002, respectively. Cytolytic activity of fecal water was not affected by UDCA. CONCLUSION: These results do not support a protective effect of UDCA supplementation against colorectal cancer in man.
|
https://pubmed.ncbi.nlm.nih.gov/12229974/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12229974
|
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0.36796748638153076,
-0.052123066037893295,
-0.20852656662464142
] |
12,229,975 |
Monitoring of tumour glucose metabolism by PET in a phase I study evaluating hormonal therapy in advanced pancreatic cancer.
|
Eckel F F, Lersch C C, Lippl F F, Schulte-Frohlinde E E, Schusdziarra V V, Helmberger H H, Neverve J J, Decker M M, Frank R R, Schwaiger M M, Weber W W
|
Scandinavian journal of gastroenterology . Vol. 37, No. 8, 2002 Aug
|
BACKGROUND: Positron emission tomography (PET) determines therapy-induced changes in tumour glucose utilization. Experimental data indicate that cholecystokinin (CCK) stimulates pancreatic cancer growth. In this study in patients with advanced pancreatic cancer, we evaluated the use of fluorodeoxyglucose (FDG) PET compared with magnetic resonance imaging (MRI) in monitoring hormonal therapy using a highly selective, non-peptide CCK receptor antagonist (SR 27897B). METHODS: Nineteen patients were enrolled on a 28-day course of SR 27897B. Initially, 4 patients received 20 mg of SR 27897B; 9 patients received 40 mg; and 6 patients 80 mg. Imaging studies, including FDG-PET and MRI, were performed at baseline and on days 14 and 28. RESULTS: No significant changes in FDG uptake by the primary tumours were observed. Rate of progression of disease was 11 (61%) of 18 evaluable patients by MRI. Median survival of all patients enrolled was 2.7 months. SR 27897B was fairly well tolerated at all doses tested. The most common side effects were gastrointestinal disorders such as diarrhoea, flatulence and nausea. CONCLUSION: SR 27897B, when used alone at the limited doses employed, led neither to an impairment of tumour glucose metabolism nor to a reduction of tumour size in advanced pancreatic cancer.
|
https://pubmed.ncbi.nlm.nih.gov/12229975/
|
[
"Clinical Trial",
"Clinical Trial, Phase I",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12229975
|
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] |
12,230,023 |
Effects of kakkon-to and sairei-to on aqueous flare elevation after complicated cataract surgery.
|
Ikeda Nariko N, Hayasaka Seiji S, Nagaki Yasunori Y, Hayasaka Yoriko Y, Kadoi Chiharu C, Matsumoto Masayuki M
|
The American journal of Chinese medicine . Vol. 30, No. 2-3, 2002
|
We evaluate prospectively the effects of traditional herbal medicines on elevation of aqueous flare after complicated cataract surgery. Twenty-seven patients with bilateral complicated cataract undergoing phacoemulsification with intraocular lens implantation were studied. The patients received no herbal medicine when the right eyes underwent cataract surgery. Fifteen patients were given kakkon-to (ge-gen-yang in Chinese) granules (7.5 g daily) and 12 patients were given sairei-to (cai-ling-tang in Chinese) granules (9.0 g daily), for 3 days before surgery, the day of surgery, and for 7 days after surgery when the left eyes underwent cataract surgery. Diclofenac eyedrops were instilled in all patients. Aqueous flare was measured before and after surgery. The differences in preoperative flare intensities between groups treated with Kakkon-to and Sairei-to were not significant. In the untreated right eyes of the kakkon-to and Sairei-to groups, the flare was 99.1 and 89.6 photon counts/msec, respectively, on day 1, and then gradually decreased. The flare intensities on days 1, 3, and 5 in the kakkon-to treated left eyes were significantly lower than in those of the untreated right eyes (Fig. 1). The flare intensities in the Sairei-to treated left eyes were the same as those in the untreated right eyes. Kakkon-to contributed to a reduction of aqueous flare elevation after surgery for complicated cataract.
|
https://pubmed.ncbi.nlm.nih.gov/12230023/
|
[
"Clinical Trial",
"Controlled Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12230023
|
[
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] |
12,230,021 |
The improvement of luteal insufficiency in fecund women by tokishakuyakusan treatment.
|
Usuki Satoshi S, Higa Tomoko Nakauchi Sawako TN, Soreya Katsumi K
|
The American journal of Chinese medicine . Vol. 30, No. 2-3, 2002
|
The effect of tokishakuyakusan, a Chinese herbal medicine, was examined, in vivo, in women with luteal insufficiency and in women with normal menstrual cycles. Luteal insufficiency was determined by daily measurement of basal body temperature and plasma progesterone levels. Tokishakuyakusan improved luteal insufficiency. Furthermore, the effects of tokishakuyakusan on prolactin, gonadotropins, steroids, angiotensin II, ANP and renin levels in the blood of women with normal menstrual cycles were studied, as were the medicine's effects on estrogens, pregnenediol and LH in the urine of the same women. Tokishakuyakusan had no adverse effect on hormonal levels in either blood or urine. Furthermore, no clinical side effects were detected. These results suggest that tokishakuyakusan improves luteal insufficiency in women but does not affect the hormonal levels of women with normal menstrual cycles.
|
https://pubmed.ncbi.nlm.nih.gov/12230021/
|
[
"Clinical Trial",
"Controlled Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12230021
|
[
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] |
12,230,024 |
The efficacy of herbal medicine (kampo) in reducing the adverse effects of IFN-beta in chronic hepatitis C.
|
Kainuma Mosaburo M, Hayashi Jun J, Sakai Shinya S, Imai Kazuaki K, Mantani Naoki N, Kohta Kazufumi K, Mitsuma Tadamichi T, Shimada Yutaka Y, Kashiwagi Seizaburo S, Terasawa Katsutoshi K
|
The American journal of Chinese medicine . Vol. 30, No. 2-3, 2002
|
The purpose of this study was to determine if the adverse effects of interferon (IFN) in hepatitis C patients could be reduced by treatment with Japanese Oriental (Kampo) medicine. Twelve patients with chronic hepatitis C were treated with a combination of IFN-beta and either Mao-to or Dai-seiryu-to (groups A and B), and 16 patients were treated with IFN-beta alone (group C). Mao-to was administered to eight patients and Dai-seiryu-to was administered to four in groups A and B, respectively. Adverse effects were evaluated by clinical and laboratory examinations. The severity of symptoms was daily self-classified into four categories (1: none, 2: very slight, 3: moderate, and 4: serious), using a questionnaire consisting of 29 items. Scores of symptom such as discomfort and fever in group A, and discomfort, general malaise, paresthesia and arthralgia in group B were significantly lower than those in group C (p < 0.05). In all patients, HCV-RNA was negative at the end of the treatment, and serum alanine aminotransferase (ALT) levels had normalized transiently in all group A and B patients with genotype 1b by 2 weeks after cessation of IFN treatment. This study indicates that Kampo medicines are useful for reducing the adverse effects accompanying IFN treatment in patients with chronic hepatitis C without reducing the antiviral effects.
|
https://pubmed.ncbi.nlm.nih.gov/12230024/
|
[
"Clinical Trial",
"Controlled Clinical Trial",
"Journal Article"
] |
12230024
|
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] |
12,230,022 |
Antioxidant and anticonvulsant effect of a modified formula of chaihu-longu-muli-tang.
|
Hung-Ming W W, Liu Chin-San CS, Tsai Jing-Jane JJ, Ko Lie-Yon LY, Wei Yau-Huei YH
|
The American journal of Chinese medicine . Vol. 30, No. 2-3, 2002
|
Antiepileptic drug therapy in individuals with epilepsy can induce free radical generation and profound lipid peroxidation. Some Chinese herbs with antiepileptic potential show antioxidant effects. We performed an open add-on study of TW970, a modified formula of the Chinese medicine "chaihu-longu-muli-tang", on 20 patients with refractory epilepsy and a seizure frequency of at least four fits per month, and another 20 patients with benign epilepsy and a seizure frequency of less than four fits per month. The control group consisted of 20 age-matched healthy adults. Seizure frequency, serum malondialdehyde (MDA), glutathione (GSH) and copper-zinc superoxide dismutase (Cu,Zn-SOD) were investigated in patients with refractory and benign epilepsy before and after four months add-on treatment of TW970. There was a decrease in seizure frequency in refractory epileptics from 13.4 +/- 3.4 to 10.7 +/- 2.5/per month, although the p value was 0.084. Before TW970 add-on treatment, a significant enhancement of lipid peroxidation with increased MDA and Cu,Zn-SOD activities together with decreased GSH were seen in refractory epileptics compared with normal controls. After TW970 add-on treatment of refractory epileptics for four months, normalization of MDA and Cu,Zn-SOD levels was achieved. Before and after TW970 add-on treatment, there were no statistically significant changes of the above-mentioned parameters in the patients with benign epilepsy. These results suggest that TW970 can reduce the seizure frequency in patients with refractory epilepsy and this may be due to the antioxidant effects of the modified formula of chaihu-longu-muli-tang.
|
https://pubmed.ncbi.nlm.nih.gov/12230022/
|
[
"Clinical Trial",
"Controlled Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12230022
|
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] |
12,230,027 |
The effect of acupuncture on the coronary arteries as evaluated by coronary angiography: a preliminary report.
|
Kurono Y Y, Egawa M M, Yano T T, Shimoo K K
|
The American journal of Chinese medicine . Vol. 30, No. 2-3, 2002
|
The Neiguan acupuncture point (EH-6) of the heart meridian is often used for circulatory disorders. To clarify this effect, we measured coronary diameters in patients with angina pectoris following acupuncture stimulation using cardioangiography. Two kinds of acupuncture stimulation, the leaving needle (LN) and the sparrow pecking method (SPM), were employed for this study. No significant differences were found between LN and SPM. Concerning the pattern of coronary reaction, coronary constriction following acupuncture showed a relationship to patients with vasospastic angina. Coronary dilation following acupuncture showed a relationship to patients with Syndrome X. The mean dilatation with acupuncture was 68.8% of that caused by isosorbide dinitrate. These findings may help to clarify the mechanism of acupuncture treatment.
|
https://pubmed.ncbi.nlm.nih.gov/12230027/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12230027
|
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] |
12,230,030 |
What's in a name? A systematic review of the nomenclature of Chinese medical formulae.
|
Park Jongbae J, Park Hi-Joon HJ, Lee Hye-Jung HJ, Emst Edzard E
|
The American journal of Chinese medicine . Vol. 30, No. 2-3, 2002
|
Traditional Chinese Medicine (TCM) has been modified to some extent in other Far Eastern countries such as Korea and Japan. Researchers of each of the three countries seem to use different English names for the same Chinese medicinal formulae. Lack of knowledge of the Chinese characters is destined to increase this confusion. In order to investigate this matter systematically, all investigations of Chinese medicine formulae published in the American Journal of Chinese Medicine (AJCM, 1997-March 2001) were evaluated. Moreover, PubMed (1966-June 2001) was searched using keywords differentiated by language, location and number of hyphens, and upper-or lower-case of the first letter of the English equivalent of each Chinese character. Fifty-four formulae of TCM were identified in 45 reports published in AJCM. Thirty-two were named in Chinese only (23 reports); six in Japanese (six reports); and five in Korean (five reports). Ten formulae were named in Japanese with the Chinese name in brackets (ten reports); and one in Chinese with the Japanese name in brackets (one report). By computerized literature search, different numbers of research papers were retrieved by using keywords differentiated by language, location and number of hyphens. Such confusion may prevent progress in the evaluation of TCM. To increase the efficiency of studies on Chinese medical formulae, standardization of terminology is required.
|
https://pubmed.ncbi.nlm.nih.gov/12230030/
|
[
"Journal Article",
"Research Support, Non-U.S. Gov't",
"Review",
"Systematic Review"
] |
12230030
|
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] |
12,230,057 |
Laparoscopic entry: a literature review and analysis of techniques and complications of primary port entry.
|
Molloy David D, Kaloo Philip D PD, Cooper Michael M, Nguyen Tuan V TV
|
The Australian & New Zealand journal of obstetrics & gynaecology . Vol. 42, No. 3, 2002 Aug
|
OBJECTIVE: To obtain consensus as to the optimal form of entry technique for access to the peritoneal cavity. DESIGN: A meta-analysis of all relevant English language studies of laparoscopic entry complications. MAIN OUTCOME MEASURES: Incidence of bowel and major vascular injuries. RESULTS: Bowel injuries occur in 0.7/1,000 and major vascular injuries in 0.4/1,000. The overall incidence of major injuries at time of entry is 1.1/1,000. The direct entry technique is associated with a significantly reduced major injury incidence of 0.5/1,000, when compared to both open and Veress entry produces (1.1 and 0.9/1,000 respectively, p = 0.0005). Entry-related bowel injuries are reported more often following general surgical laparoscopies than with gynaecological procedures (p = 0.001). No such difference is seen in the incidence of vascular injuries (p = 0.987). Open entry is statistically more likely to be associated with bowel injury than either Veress needle or direct entry However, open entry appears to minimise vascular injury at time of entry. CONCLUSIONS: There remains no clear evidence as to the optimal form of laparoscopic entry in the low-risk patient. However, direct entry may be an under-utilised and safe alternative to the Veress needle and open entry technique.
|
https://pubmed.ncbi.nlm.nih.gov/12230057/
|
[
"Journal Article",
"Meta-Analysis",
"Research Support, Non-U.S. Gov't"
] |
12230057
|
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12,230,061 |
A prospective randomised double-blind placebo controlled trial to assess whether gas drains reduce shoulder pain following gynaecological laparoscopy.
|
Swift Gary G, Healey Martin M, Varol Nesrin N, Maher Peter P, Hill David D
|
The Australian & New Zealand journal of obstetrics & gynaecology . Vol. 42, No. 3, 2002 Aug
|
OBJECTIVE: To assess the effects on patient discomfort of an intraabdominal passive gas drain left for four hours postoperatively following gynaecologic laparoscopic surgery. DESIGN: A prospective randomised double-blinded placebo controlled trial. SETTING: University tertiary hospital and private hospital. POPULATION OR SAMPLE: Eighty women having a laparoscopic gynaecological procedure for benign disease. METHODS: A drain was placed via the umbilical port at the conclusion of the surgical procedure and was removed four hours postoperatively. The researcher, assessor and patient were all blinded as to the patency or occlusion of the drain. Patients were asked to complete questionnaires at regular intervals up to five days postoperatively. MAIN OUTCOME MEASURES: Visual analogue scale (VAS) to assess overall pain, shoulder and chest pain, abdominal pain, bloating and energy prior to surgery and at intervals up to five days postoperatively. RESULTS AND CONCLUSIONS: No complications were attributed to the presence and withdrawal of the drain tube. Shoulder pain following operative or diagnostic laparoscopy was significantly reduced for 12, 24, 48 and 72 hours by the presence of a patent passive gas drain for the first four hours postoperatively. The drains were easy to use and had no associated morbidity We recommend that in the absence of the need for an active drain, all patients undergoing laparoscopy should have a gas drain inserted for a period of four hours after the completion of the procedure.
|
https://pubmed.ncbi.nlm.nih.gov/12230061/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12230061
|
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0.05311345309019089,
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0.03008424863219261,
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] |
12,230,090 |
Regional differences in distribution volume of I-123 IMP in the human brain: effect on CBF calculated by ARG method.
|
Inoue Kentaro K, Ito Hiroshi H, Nakagawa Manabu M, Goto Ryoi R, Yamazaki Tetsuro T, Fukuda Hiroshi H
|
Annals of nuclear medicine . Vol. 16, No. 5, 2002 Jul
|
OBJECTIVE: Two methods of quantitating cerebral blood flow (CBF) with iodine-123-labeled N-isopropyl-p-iodoamphetamine (I-123 IMP) and a two-compartment model had been proposed; one is the table look-up (TLU) method and the other is the autoradiographic (ARG) method. The TLU method provides values of the cerebral blood flow (CBF) values and distribution volume of I-123 IMP (Vd) independently. In the ARG method, a fixed Vd is applied for the entire brain to calculate CBF. Our purpose was to evaluate regional differences in Vd in the human brain, or possible effects of regional differences in Vd on CBF calculated by the ARG method. METHODS: In the present study, two SPECT scans were acquired from each of eight normal subjects (aged 44.0 +/- 16.7) at 40 min and 180 min of mid-scan-time after intravenous 1 min infusion of 111 MBq IMP. A single arterial blood sampling was performed 10 min after the IMP infusion. All images were anatomically normalized and analyzed with SPM99 and Matlab. We generated CBF and Vd images for each subject by the TLU method and evaluated differences in Vd among brain structures. We subsequently generated another set of CBF images by the ARG method and examined differences between CBF calculated by the TLU method and that by the ARG method. RESULTS: Significant main effects of subject and brain structure in Vd were observed (two-way ANOVA). Vd values were higher in the deep gray matter than in the cerebral cortical regions. Among the cerebral cortical regions, no significant difference in Vd was observed. In spite of the significant differences in Vd among the brain structures, the voxel-by-voxel analyses as well as the ROI analyses revealed no statistically significant difference between CBF calculated by the TLU method and that by the ARG method. CONCLUSIONS: Although regional differences in Vd were observed, the present results support the assumption that a fixed Vd does not cause significant error in the calculation of CBF by the ARG method.
|
https://pubmed.ncbi.nlm.nih.gov/12230090/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Research Support, Non-U.S. Gov't",
"Validation Study"
] |
12230090
|
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12,230,092 |
Serial assessment of left ventricular performance at rest and during bicycle exercise by ECG-gated myocardial perfusion SPECT.
|
Kumita Shin-ichiro S, Cho Keiichi K, Nakajo Hidenobu H, Toba Masahiro M, Akiyama Kazuyoshi K, Fukushima Yoshimitsu Y, Mizumura Sunao S, Kumazaki Tatsuo T, Sano Junko J, Munakata Kazuo K, Kishida Hiroshi H, Takano Teruo T
|
Annals of nuclear medicine . Vol. 16, No. 5, 2002 Jul
|
UNLABELLED: The present study evaluates left ventricular performance during exercise by ECG-gated myocardial perfusion SPECT with short-time data collection. METHODS: The study population consisted of 10 healthy volunteers (Group N) and 9 patients with ischemic heart disease (Group I). Seven patients in Group I had a history of prior myocardial infarction. Rest ECG-gated SPECT was performed 40 min after an injection of Tc-99m-tetrofosmin (555-740 MBq). After resting data acquisition, Group N underwent up to two 5-min stages of exercise (75 and 125 watts) on a detachable bicycle ergometer. The Group I patients all underwent symptom-limited, maximal testing on the ergometer. ECG-gated SPECT data were acquired from both groups for 3 min at rest and during the last 3 min of each exercise stage. RESULTS: Significant increases occurred in LVEF from rest to peak stress in both groups (from 55.4 +/- 5.8 to 66.6 +/- 4.1% in group N, p < 0.0001; from 49.0 +/- 12.8 to 56.7 +/- 13.8% in Group I, p < 0.001). The LVESV values significantly decreased to peak stress in Group N (from 49.9 +/- 13.1 to 37.8 +/- 10.0 ml, p < 0.0001), whereas LVEDV did not change (from 110.6 +/- 18.9 to 112.0 +/- 19.0 ml). In contrast, the LVESV values at rest and under peak stress were similar in Group I (from 52.6 +/- 23.9 to 51.7 +/- 31.4 ml) and LVEDV in Group I at peak exercise tended to increase (from 102.8 +/- 36.7 to 111.3 +/- 39.0 ml). The changes in LVESV from rest to peak stress were significantly different between Groups N and I (-12.1 +/- 6.3 vs. -0.9 +/- 11.6 ml, p < 0.02). CONCLUSION: ECG-gated SPECT with short-time data collection can assess left ventricular function during exercise and may offer useful information for evaluating patients with ischemic heart disease.
|
https://pubmed.ncbi.nlm.nih.gov/12230092/
|
[
"Clinical Trial",
"Controlled Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12230092
|
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0.2242058962583542,
0.06466753780841827,
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0.10776205360889435,
0.01898655667901039,
-0.10514404624700546
] |
12,230,091 |
Evaluation of a commercial PET tomograph-based system for the quantitative assessment of rCBF, rOEF and rCMRO2 by using sequential administration of 15O-labeled compounds.
|
Shidahara Miho M, Watabe Hiroshi H, Kim Kyeong Min KM, Oka Hisashi H, Sago Masayoshi M, Hayashi Takuya T, Miyake Yoshinori Y, Ishida Yoshio Y, Hayashida Kohei K, Nakamura Takashi T, Iida Hidehiro H
|
Annals of nuclear medicine . Vol. 16, No. 5, 2002 Jul
|
The purpose of this study was to develop a reliable and practical strategy that generates quantitative CBF and OEF maps accurately from PET data sets obtained with 15O-tracers. Sequential sinogram data sets were acquired after the administration of 15O-tracers, and combined single-frame images were obtained. The delay time between sampled input function and the brain was estimated from the H2(15)O study with the whole brain and the arterial time-activity curves (TACs). The whole-brain TACs were obtained from the reconstructed images (image-base method) and the sinogram data (sinogram-base method). Six methods were also evaluated for the dead-time and decay correction procedures in the process of generating a single-frame image from the dynamic sinogram. The estimated delay values were similar with both the sinogram-based and image-based methods. A lumped correction factor to a previously added single-frame sinogram caused an underestimation of CBF, OEF and CMRO2 by 16% at maximum, as compared with the correction procedure for a short sinogram. This suggested the need for a dynamic acquisition of a sinogram with a short interval. The proposed strategy provided an accurate quantification of CBF and OEF by PET with 15O-tracers.
|
https://pubmed.ncbi.nlm.nih.gov/12230091/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article"
] |
12230091
|
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] |
12,230,093 |
Clinical impact of whole body FDG-PET on the staging and therapeutic decision making for malignant lymphoma.
|
Sasaki Masayuki M, Kuwabara Yasuo Y, Koga Hirofumi H, Nakagawa Makoto M, Chen Tao T, Kaneko Kouichirou K, Hayashi Kazutaka K, Nakamura Katsumasa K, Masuda Kouji K
|
Annals of nuclear medicine . Vol. 16, No. 5, 2002 Jul
|
OBJECTIVES: The aim of this study is to evaluate the clinical impact of whole-body FDG-PET for the pre-therapeutic evaluation of malignant lymphoma and compared to that of 67Ga-scintigraphy when added to non-RI examinations. METHODS: We examined 46 patients with malignant lymphoma including 42 newly diagnosed cases and 4 relapsed cases. Whole-body FDG-PET was started 63 minutes after the administration of FDG with ECAT EXACT HR+. The clinical stage of each patient was determined based on the results of a non-RI examination (consisting of physical examination, CT, gastrointestinal studies and bone marrow aspiration), 67Ga planar images and FDG-PET. Discrepant findings were verified based on the response to treatment and the findings of a follow-up examination more than 6 months after treatment. Finally, 152 nodal regions and 19 extranodal tissues were found to be involved by disease. RESULTS: In the 152 nodal lesions, FDG-PET detected 54 nodal lesions in addition to 98 lesions detected by non-RI examinations, whereas 67Ga-scintigraphy detected 14 additional lesions. The sensitivity of non-RI, non-RI + 67Ga and non-RI + FDG was 64.5%, 73.7% and 100.0%, respectively. In 19 extranodal lesions, FDG-PET detected 5 extranodal lesions in addition to 13 lesions detected by non-RI examinations, whereas 67Ga-scintigraphy detected 1 additional lesion. The sensitivity of non-RI, non-RI + 67Ga and non-RI + FDG was 68.4%, 73.7% and 94.7%, respectively. When combining the FDG-PET findings with the non-RI findings, the improvement of the detectability was much higher than that when 67Ga findings were combined to the non-RI findings. For the staging of lymphoma, the non-RI and non-RI + 67Ga findings accurately diagnosed 76.1% and 80.4%, respectively, whereas the non-RI + FDG findings accurately diagnosed 82.6%. Finally, FDG-PET resulted in changes in the clinical management of 8 patients (17.4%). CONCLUSIONS: FDG-PET offers more information in addition to the findings of conventional diagnostic methods than 67Ga-scintigraphy in order to accurately detect malignant lymphoma. FDG-PET can therefore play an important role in therapeutic decision making on lymphoma.
|
https://pubmed.ncbi.nlm.nih.gov/12230093/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article"
] |
12230093
|
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] |
12,230,097 |
Radioguided surgery in primary hyperparathyroidism.
|
Küçük N O NO, Arican P P, Koçak S S, Aras G G
|
Annals of nuclear medicine . Vol. 16, No. 5, 2002 Jul
|
UNLABELLED: Surgical neck exploration is usually made in primary hyperparathyroidism (PHPT). Localization of the adenoma or detection of hyperplasia may reduce the operation period and limit the extent of the surgery. In this study the effficacy of preoperative Tc-99m MIBI scintigraphy and intraoperative gamma probe was evaluated. MATERIALS AND METHODS: Six patients with PHPT had preoperative Tc-99m MIBI parathyroid scintigraphy and intraoperative gamma probe (IGP) was used in surgical neck exploration. RESULTS: Parathyroid adenoma was observed in 2/6 patients on scintigraphy in the right retroclavicular region and the left lobe of the thyroid. Both of them were clearly detected by IGP during the surgery and easily removed by the surgeon in a short time (35 min) with a small incision. Pathologic examination confirmed the parathyroid adenoma. No abnormal MIBI uptake was not observed in scintigraphy in 4/6 patients. Subtotal parathyroidectomy was performed in these patients. CONCLUSION: Preoperative Tc-99m MIBI scintigraphy and the use of IGP may limit the exploration and also the operation time and reduce surgical complications.
|
https://pubmed.ncbi.nlm.nih.gov/12230097/
|
[
"Clinical Trial",
"Journal Article"
] |
12230097
|
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] |
12,230,139 |
Influences of current mood and noise sensitivity on judgments of noise annoyance.
|
Vastfjall Daniel D
|
The Journal of psychology . Vol. 136, No. 4, 2002 Jul
|
Noise annoyance is one of the most studied reactions to auditory events. Previous research has demonstrated that annoyance reactions may be mediated by individual characteristics such as personality, attitudes, and noise sensitivity (traits). Transient temporary states such as an individual's current mood have been studied to a lesser extent. The author studied annoyance reactions to an everyday noise in participants who either were slightly annoyed or in a neutral affective state. The results showed that current mood had an overall effect on judgments of annoyance and on a participant's preference for sound. In addition, a participant's current mood interacted with noise sensitivity. These results indicate that both individual noise sensitivity (traits) and transient moods (states) are important for human auditory perception and evaluation.
|
https://pubmed.ncbi.nlm.nih.gov/12230139/
|
[
"Clinical Trial",
"Controlled Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12230139
|
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] |
12,230,146 |
Symbols presentation modality as a determinant of gambling behavior.
|
Ladouceur Robert R, Sévigny Serge S
|
The Journal of psychology . Vol. 136, No. 4, 2002 Jul
|
In this study, the authors investigated the effects that modality of symbol presentation on video lottery terminals (sequential vs. simultaneous) has on gambling behavior. They predicted that sequential presentation would incite players to prolong their gambling session. Results confirmed this prediction and showed that modality of presentation is a determinant of gambling persistency. The authors discuss the relationship between modality of presentation, hopes of an imminent win, losses, and practical and theoretical issues about other cognitive and emotional elements that may influence gamblers' behaviors.
|
https://pubmed.ncbi.nlm.nih.gov/12230146/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12230146
|
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12,230,148 |
Visual habituation at five months: short-term reliability of measures obtained with a new polynomial regression criterion.
|
Lavoie Chantale C, Desrochers Stéphan S
|
The Journal of genetic psychology . Vol. 163, No. 3, 2002 Sep
|
Using a new polynomial regression criterion, the authors investigated empirically the short-term reliability of infants' visual habituation measures. Twenty-one 5-month-old infants were tested twice with a 1-day interval. Results revealed many reliable habituation measures, a reliable reaction to novelty measure, and a new reliable measure of interest. The 2nd-order polynomial regression criterion probably produced this improvement because it uses all of the available looking time data.
|
https://pubmed.ncbi.nlm.nih.gov/12230148/
|
[
"Clinical Trial",
"Journal Article"
] |
12230148
|
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12,230,149 |
Improving children's mental rotation accuracy with computer game playing.
|
De Lisi Richard R, Wolford Jennifer L JL
|
The Journal of genetic psychology . Vol. 163, No. 3, 2002 Sep
|
The authors investigated the relation between mental rotation (MR) and computer game-playing experience. Third grade boys (n = 24) and girls (n = 23) completed a 2-dimensional MR test before and after playing computer games (during 11 separate 30-min sessions), which either involved the use of MR skills (the experimental group) or did not involve the use of MR skills (the control group). The experimental group outperformed the control group on the MR posttest but not on the pretest. Boys outperformed girls on the pretest but not on the posttest. Children whose initial MR performance was low improved after playing computer games that entailed MR skills. The findings imply that computer-based instructional activities can be used in schools to enhance children's spatial abilities.
|
https://pubmed.ncbi.nlm.nih.gov/12230149/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12230149
|
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] |
12,230,150 |
The importance of social context in cross-cultural comparisons: first graders in Colombia and the United States.
|
Pilgrim Colleen C, Rueda-Riedle Alba A
|
The Journal of genetic psychology . Vol. 163, No. 3, 2002 Sep
|
The authors explored the cultural constructs of individualism and collectivism by investigating the prosocial behavior of 1st graders (N = 202; 110 girls, 92 boys) in countries typically classified as collectivist (Colombia, South America) and individualist (United States). Contrary to expectations, U.S. children shared more than Colombian children did. However, U.S. children were more likely to take candy from another child without permission (demonstrating individualism). Results indicated that in both countries sharing was greater with friends than with other fellow classmates, and children frequently reported friendship as the reason they shared. Findings support the importance of the social context, such as the relationship between participants, in cross-cultural research and suggest that simple dichotomies of culture often overlook complex associations between culture and behavioral differences.
|
https://pubmed.ncbi.nlm.nih.gov/12230150/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12230150
|
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12,230,152 |
Narrative discourse and theory of mind development.
|
Guajardo Nicole R NR, Watson Anne C AC
|
The Journal of genetic psychology . Vol. 163, No. 3, 2002 Sep
|
The authors examined experimentally whether exposure to social discourse about concepts related to mental states could promote changes in children's theory of mind understanding. In 2 studies, 3- to 4-year-old children were assigned to either a training or a no training control condition. All children were administered several theory of mind measures at pretest and 2 posttests. Training was not effective in improving performance in Study 1 (n = 37); but in Study 2 (n = 54), modifications of the training procedure led to significant improvements on measures of false belief and deception from pretest to 1st posttest. The findings support the influence of social discourse on children's theory of mind development.
|
https://pubmed.ncbi.nlm.nih.gov/12230152/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12230152
|
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] |
12,230,153 |
Verbal and nonverbal interactions of four- and five-year-old friends in potential conflict situations.
|
Tomada Giovanna G, Schneider Barry H BH, Fonzi Ada A
|
The Journal of genetic psychology . Vol. 163, No. 3, 2002 Sep
|
Dyads of 4- and 5-year-old friends and nonfriends attending preschools in central Italy were identified by friendship nominations. The 217 dyads of friends and non-friends participated in 2 closed-field tasks designed to simulate real-life situations of potential conflict. In the 4-year-old cohort, there were no significant differences in the behavior of the partners in either of the situations. However, at age 5 years, friends respected the rules of a fast-paced competitive game significantly more than did nonfriends. In discussing how to share a single object (a chocolate egg with a toy inside), 5-year-old friends were more likely to reach agreement than were nonfriends. The results suggest important developmental changes in the processes of negotiation and sharing within the preschool years.
|
https://pubmed.ncbi.nlm.nih.gov/12230153/
|
[
"Clinical Trial",
"Controlled Clinical Trial",
"Journal Article"
] |
12230153
|
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] |
12,230,154 |
Preschoolers' inhibition in their home: relation to temperament.
|
Ullrich Anja A, Carroll Marjorie M, Prigot Joyce J, Fagen Jeffrey J
|
The Journal of genetic psychology . Vol. 163, No. 3, 2002 Sep
|
Researchers assessed 58 preschoolers' reactions to an unfamiliar person and unfamiliar objects in their familiar home environment. Children participated in a 30-min procedure designed to elicit behavioral inhibition, including (a) a free-play period with a stranger present, (b) a structured interaction with the stranger, and (c) uncertainty-eliciting tasks. Behaviors representing the child's reactions toward the mother, stranger, and novel objects were coded. Mothers completed a temperament scale. Preschoolers exhibited behaviors indicative of inhibition toward unfamiliar social and nonsocial stimuli; behaviors remained stable across increasingly intrusive episodes. The approach/withdrawal component of temperament was related to behavioral inhibition. Individual differences in mood did not appear to be related to differences in inhibition. Parent reported temperament was related to researcher-observed behaviors.
|
https://pubmed.ncbi.nlm.nih.gov/12230154/
|
[
"Clinical Trial",
"Journal Article",
"Research Support, U.S. Gov't, P.H.S."
] |
12230154
|
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] |
12,230,222 |
Randomized trial with itraconazole, ketoconazole and sulfadiazine in paracoccidioidomycosis.
|
Shikanai-Yasuda M A MA, Benard G G, Higaki Y Y, Del Negro G M B GM, Hoo Sun S, Vaccari E H EH, Gryschek R C B RC, Segurado A A C AA, Barone A A AA, Andrade D R DR
|
Medical mycology . Vol. 40, No. 4, 2002 Aug
|
Forty-two patients with active paracoccidioidomycosis were randomized to receive itraconazole (50-100 mg d(-1)), ketoconazole (200-400 mg d(-1)) or sulfadiazine (100-150 mg kg d(-1) up to 6 g d(-1)) for 4-6 months, followed by slow release sulfa until negativity of serological tests. All 14 patients in itraconazole and sulfadiazine groups and 13 in the ketoconazole group showed an adequate clinical response to the chemotherapy. One patient in the latter group showed treatment failure according to clinical and mycological criteria. The test of the hypothesis that the drugs reduced antibody levels up to ten months of treatment showed a p value equal to 0.0001 for itraconazole, 0.017 for ketoconazole and 0.0012 for sulfadiazine; this reduction was similar for the three groups. In this first randomized study for the treatment of paracoccidioidomycosis we could not show superiority of any one regimen over the others in the clinical and serological responses of patients with the moderately severe form of the disease.
|
https://pubmed.ncbi.nlm.nih.gov/12230222/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12230222
|
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] |
12,230,333 |
Postcontraction influences on reaction time.
|
Etnyre Bruce B, Kinugasa Takashi T
|
Research quarterly for exercise and sport . Vol. 73, No. 3, 2002 Sep
|
The purpose of this study was to compare reaction time (RT) and fractionated RT components (premotor and motor times) between normal and postcontraction conditions. Twelve participants performed 20 trials each of control and postcontraction RT conditions. For the control condition, participants executed a learned, rapid, knee-extension contraction response to an auditory stimulus. The postcontraction condition was identical to the control condition except that the participants performed a 3-s isometric contraction of the knee extensor muscles prior to an auditory stimulus. Muscle activity was recorded from the quadriceps muscle group. Results indicated that the postcontraction condition was significantly faster than the control condition for the average RT, premotor time, and motor time. It was concluded that reaction time, processing time, and muscle contraction time for a learned task could be significantly reduced following an isometric contraction.
|
https://pubmed.ncbi.nlm.nih.gov/12230333/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12230333
|
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] |
12,230,335 |
Effects of multicycle-run training on triathlete performance.
|
Hue Olivier O, Valluet Alex A, Blonc Stephen S, Hertogh Claude C
|
Research quarterly for exercise and sport . Vol. 73, No. 3, 2002 Sep
|
The purpose of this study was to determine the effect of triathlon training using multiple, short cycle-run sequences (multicycle-run training) on cycle-run performance. Twelve competitive triathletes, randomized into two groups, underwent multicycle-run training or normal training for 6 weeks. During this period, baseline training remained the same for both groups, and only the high-intensity component differed. The differentiated exercises were performed at or above 100% maximal aerobic velocity. The improvements in overall cycle-run performance were similar (3.3 +/- 1.4 % and 6.1 +/- 1.7% rise in Performance in multicycle-run and normal training, respectively). However, the improvement in performance was significantly greater for the multicycle-run training (-11.2 +/- 6.8 s versus -1.2 +/- 7. 7 s for multicycle-run training and normal training, respectively) during both the cycle-run change and the first 333-m lap, which together are termed the cycle-run transition. We concluded that 6 weeks of multicycle-run training did not induce greater improvement in cycle-run performance than did normal training in competitive triathletes. However, it did induce significant improvement in the cycle-run transition. This finding indicates that multicycle-run training may help competitive triathletes to develop greater skill and better physiological adaptations during this critical transition period of the triathlon race.
|
https://pubmed.ncbi.nlm.nih.gov/12230335/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12230335
|
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12,230,338 |
Injury rehabilitation: a goal-setting intervention study.
|
Evans Lynne L, Hardy Lew L
|
Research quarterly for exercise and sport . Vol. 73, No. 3, 2002 Sep
|
The study examined the effects of a 5-week goal-setting intervention on athletes' rehabilitation adherence, self-efficacy, treatment efficacy, and the psychological response variables: dispirited and reorganization. Participants were matched across six variables and randomly assigned to one of three groups: goal-setting intervention, social support control, and control. The results confirmed some of the hypothesized effects of the goal-setting intervention: (a) athlete self-report of adherence showed the goal-setting group adhered significantly more to the rehabilitation program than the other two groups; (b) the goal-setting intervention resulted in significant group differences for self-efficacy (the goal-setting group having the highest level of self-efficacy); and (c) there was a significant increase across time for reorganization and decrease across time for dispirited (between specific time phases).
|
https://pubmed.ncbi.nlm.nih.gov/12230338/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12230338
|
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12,230,353 |
Is volume related to outcome in health care? A systematic review and methodologic critique of the literature.
|
Halm Ethan A EA, Lee Clara C, Chassin Mark R MR
|
Annals of internal medicine . Vol. 137, No. 6, 2002 Sep 17
|
PURPOSE: To systematically review the methodologic rigor of the research on volume and outcomes and to summarize the magnitude and significance of the association between them. DATA SOURCES: The authors searched MEDLINE from January 1980 to December 2000 for English-language, population-based studies examining the independent relationship between hospital or physician volume and clinical outcomes. Bibliographies were reviewed to identify other articles of interest, and experts were contacted about missing or unpublished studies. STUDY SELECTION: Of 272 studies reviewed, 135 met inclusion criteria and covered 27 procedures and clinical conditions. DATA EXTRACTION: Two investigators independently reviewed each article, using a standard form to abstract information on key study characteristics and results. DATA SYNTHESIS: The methodologic rigor of the primary studies varied. Few studies used clinical data for risk adjustment or examined effects of hospital and physician volume simultaneously. Overall, 71% of all studies of hospital volume and 69% of studies of physician volume reported statistically significant associations between higher volume and better outcomes. The strongest associations were found for AIDS treatment and for surgery on pancreatic cancer, esophageal cancer, abdominal aortic aneurysms, and pediatric cardiac problems (a median of 3.3 to 13 excess deaths per 100 cases were attributed to low volume). Although statistically significant, the volume-outcome relationship for coronary artery bypass surgery, coronary angioplasty, carotid endarterectomy, other cancer surgery, and orthopedic procedures was of much smaller magnitude. Hospital volume-outcome studies that performed risk adjustment by using clinical data were less likely to report significant associations than were studies that adjusted for risk by using administrative data. CONCLUSIONS: High volume is associated with better outcomes across a wide range of procedures and conditions, but the magnitude of the association varies greatly. The clinical and policy significance of these findings is complicated by the methodologic shortcomings of many studies. Differences in case mix and processes of care between high- and low-volume providers may explain part of the observed relationship between volume and outcome.
|
https://pubmed.ncbi.nlm.nih.gov/12230353/
|
[
"Journal Article",
"Research Support, Non-U.S. Gov't",
"Review",
"Systematic Review"
] |
12230353
|
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] |
12,230,419 |
Prolonged thromboprophylaxis with oral anticoagulants after total hip arthroplasty: a prospective controlled randomized study.
|
Prandoni Paolo P, Bruchi Olinto O, Sabbion Paola P, Tanduo Cinzia C, Scudeller Alberta A, Sardella Corrado C, Errigo Gabriella G, Pietrobelli Francesco F, Maso Gianni G, Girolami Antonio A
|
Archives of internal medicine . Vol. 162, No. 17, 2002 Sep 23
|
BACKGROUND: The optimal duration of thromboprophylaxis after major orthopedic surgery is controversial. Although oral anticoagulants are still widely used for the prevention of venous thromboembolism after hip replacement, to our knowledge no study has assessed the benefit of prolonging anticoagulation beyond the hospital stay. METHODS: Consecutive patients who had received warfarin sodium prophylaxis after total hip arthroplasty were randomized to stop taking the drug at the time of hospital discharge or to continue taking it for 4 more weeks. The rate of symptomatic and asymptomatic venous thromboembolic events (as shown by compression ultrasonography of the proximal-vein system) occurring during the study period was compared between the 2 groups. The study was prematurely terminated after the inclusion of the first 360 patients because a statistically significant and clinically relevant superiority of extended over short-term thromboprophylaxis was observed. RESULTS: Objectively confirmed venous thromboembolic complications were recorded in 10 patients: 9 (5.1%) in the group of 176 control patients, and 1 (0.5%) in the group of 184 patients who continued the warfarin treatment. The absolute difference in the incidence of events was 4.57% (95% confidence interval [CI], 1.15-7.99). The relative risk of venous thromboembolism developing in control patients compared with patients assigned to extended thromboprophylaxis was 9.4 (95% CI, 1.2-73.5). The number needed to treat was 22. Major bleeding developed in 1 patient who was randomized to the extended prophylaxis group (0.5%; 95% CI, 0.02-3.0) compared with none in the control group. CONCLUSION: Extending prophylaxis with warfarin for a few more weeks beyond the hospital stay has the potential to considerably improve the outcome of patients who undergo hip arthroplasty.
|
https://pubmed.ncbi.nlm.nih.gov/12230419/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial"
] |
12230419
|
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12,230,423 |
Thrombolysis for acute stroke in routine clinical practice.
|
Bravata Dawn M DM, Kim Nancy N, Concato John J, Krumholz Harlan M HM, Brass Lawrence M LM
|
Archives of internal medicine . Vol. 162, No. 17, 2002 Sep 23
|
BACKGROUND: Studies have demonstrated that thrombolytic therapy for acute stroke can be given safely and effectively in study settings with experienced clinicians, but the patient outcomes associated with thrombolytic therapy in routine clinical practice require investigation. OBJECTIVES: To compare outcomes among patients given intravenous thrombolysis in routine clinical practice with the results of the National Institute of Neurological Disorders and Stroke rt-PA Study (NINDS cohort) and to examine whether protocol deviations are associated with adverse events. METHODS: Retrospective cohort of community-based patients given thrombolysis for acute stroke from May 1, 1996, through December 31, 1998, in 16 Connecticut hospitals (Connecticut cohort). RESULTS: Forty-two (67%) of 63 patients in the Connecticut cohort had at least 1 major protocol deviation, and 61 (97%) had major or minor protocol deviations. Overall, the in-hospital mortality was higher in the Connecticut cohort (16/63 [25%]) compared with the NINDS cohort (40/312 [13%]; P =.01). The serious extracranial hemorrhage rate was also higher for the Connecticut cohort (8/63 [13%] vs 5/312 [2%]; P =.001). Patients in the Connecticut cohort without major protocol deviations had outcomes similar to those in the NINDS cohort; however, patients in the Connecticut cohort with major protocol deviations had higher rates of in-hospital mortality (13/42 [31%] vs 40/312 [13%]; P =.002) and serious extracranial hemorrhage (7/42 [17%] vs 5/312 [2%]; P =.001). CONCLUSIONS: Protocol deviations occur commonly when thrombolytic therapy is given to stroke patients in routine clinical practice. Patients who receive thrombolysis with major protocol deviations have higher rates of in-hospital mortality and serious extracranial hemorrhage than patients in the NINDS cohort.
|
https://pubmed.ncbi.nlm.nih.gov/12230423/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, Non-P.H.S."
] |
12230423
|
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] |
12,230,484 |
Early quality of life benefits of icodextrin in peritoneal dialysis.
|
Guo Amy A, Wolfson Marsha M, Holt Robert R
|
Kidney international. Supplement . No. 81, 2002 Oct
|
UNLABELLED: Early quality of life benefits of icodextrin in peritoneal dialysis. BACKGROUND: The impact of new therapies on patient quality of life (QOL) is emerging as an important indicator of the value of these therapies. In patients on dialysis, previous QOL evaluations have focused mainly on comparative approaches between modalities, or on longitudinal trends within a modality, but few have evaluated technical innovations or introduction of new therapies. The aim of the present study was to assess the early effects of a new dialysis solution (icodextrin) on the QOL of peritoneal dialysis patients. The QOL is compared with that of patients on dextrose, and the impact of demographic, and clinical characteristics on patients' QOL is examined. METHODS: The kidney disease quality of life questionnaire (KDQOL) was administered to patients who participated in a phase III double-blind, parallel group, active-controlled trial to evaluate the efficacy and safety of a peritoneal dialysis (PD) solution containing icodextrin in comparison with dextrose PD solution. A total of 93 patients (58 icodextrin, and 35 dextrose) completed the questionnaire at both baseline and after 13 weeks. In addition to patients QOL, patients' demographic and clinical characteristics were recorded at both baseline and 13 weeks. RESULTS: Mean change scores from baseline to 13 weeks of icodextrin patients were substantially higher (> or =5) than dextrose, particularly with respect to general health perception, physical functioning, role-physical, and many KDQOL symptom items such as lack of strength, washed out or drained, lack of appetite, faintness or dizziness, dry skin, cramps after an exchange or treatment, cramps during an exchange or treatment, and muscle spasms or twitching. At 13 weeks, icodextrin patients had significantly improved symptoms, and rated their health in general higher than those patients in the dextrose group. Upon multivariate analysis, icodextrin contributed significantly to the improvement of patients' mental health, general health, and symptoms such as muscle spasms or twitching, cramps during an exchange or treatment, cramps after an exchange or treatment, itchy skin, and faintness or dizziness. CONCLUSIONS: Peritoneal dialysis patients treated with icodextrin experienced substantial quality of life improvement at 13 weeks after the start of treatment when compared to dextrose patients. Further research is necessary to determine patients' quality of life over time in a longitudinal study setting.
|
https://pubmed.ncbi.nlm.nih.gov/12230484/
|
[
"Clinical Trial",
"Clinical Trial, Phase III",
"Journal Article",
"Randomized Controlled Trial"
] |
12230484
|
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12,230,594 |
The efficacy and safety of Tanacetum parthenium (feverfew) in migraine prophylaxis--a double-blind, multicentre, randomized placebo-controlled dose-response study.
|
Pfaffenrath V V, Diener H C HC, Fischer M M, Friede M M, Henneicke-von Zepelin H H HH,
|
Cephalalgia : an international journal of headache . Vol. 22, No. 7, 2002 Sep
|
Tanacetum parthenium (feverfew), is a well-known herb for the prophylactic treatment of migraine. The primary objective was to show a dose-response of a new stable extract (MIG-99) reproducibly manufactured with supercritical CO2 from feverfew (T. parthenium). Furthermore, the study should provide data on the safety and tolerability of MIG-99. In a randomized, double-blind, multicentre, controlled trial with an adaptive design, the clinical efficacy and safety of three dosages of MIG-99 (2.08 mg; 6.25 mg; 18.75 mg t.i.d.) were compared with placebo. The patients (n = 147) suffered from migraine with and without aura according to International Headache Society (IHS) criteria and were treated with one of the study medications for 12 weeks after a 4-week baseline period. The primary efficacy parameter was the number of migraine attacks during the last 28 days of the treatment period compared with baseline. Secondary endpoints were total and average duration and intensity of migraine attacks, mean duration of the single attack, number of days with accompanying migraine symptoms, number of days with inability to work due to migraine as well as type and amount of additionally taken medications for the treatment of migraine attacks. The design of the study included a pre-planned adaptive interim analysis for patients with at least four migraine attacks within the baseline period. With respect to the primary and secondary efficacy parameter, a statistically significant difference was not found between the overall and the confirmatory intention-to-treat (ITT) sample in the exploratorily analysed four treatment groups. The frequency of migraine attacks for the predefined confirmatory subgroup of patients (n = 49) with at least four migraine attacks during the baseline period decreased in a dose-dependent manner (P = 0.001). The highest absolute change of migraine attacks was observed under treatment with 6.25 mg t.i.d. (mean +/- SD = -1.8 +/- 1.5 per 28 days) compared with placebo (-0.3 +/- 1.9; P = 0.02). Overall, 52 of 147 (35%) patients reported at least one adverse event (AE). The incidence of AEs in the active treatment groups was similar to that in the placebo group, and no dose-related effect was observed in any safety parameter. MIG-99 failed to show a significant migraine prophylactic effect in general. Accordingly, in the ITT analysis a dose-response relationship could not be observed. MIG-99 was shown to be effective only in a small predefined subgroup of patients with at least four attacks during the 28-day baseline period where the most favourable benefit-risk ratio was observed with a dosage of three capsules of 6.25 mg MIG-99 extract per day. Because of the low number of patients, these findings need to be verified in a larger sample. The incidence of AEs was similar for all treatment groups.
|
https://pubmed.ncbi.nlm.nih.gov/12230594/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Multicenter Study",
"Randomized Controlled Trial"
] |
12230594
|
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] |
12,230,618 |
Three-month neoadjuvant hormonal therapy before radical prostatectomy: a 7-year follow-up of a randomized controlled trial.
|
Aus G G, Abrahamsson P-A PA, Ahlgren G G, Hugosson J J, Lundberg S S, Schain M M, Schelin S S, Pedersen K K
|
BJU international . Vol. 90, No. 6, 2002 Oct
|
OBJECTIVE: To describe the outcome, assessed as the level of prostate specific antigen (PSA), of a mature (more than half the events recorded) prospective randomized study with a median follow-up of 82 months of neoadjuvant hormonal therapy before radical prostatectomy, as this has been suggested to decrease the rate of positive surgical margins (i.e. provide greater potential to completely excise the tumour). PATIENTS AND METHODS: From December 1991 to March 1994, 126 patients with clinically localized prostate cancer were randomized between direct radical prostatectomy or a 3-month course of a gonadotrophin-releasing hormone analogue before surgery. The patients were followed by PSA determinations and a value of > 0.5 ng/mL used to define progression. RESULTS: The incidence of positive surgical margins decreased from 45.5% to 23.6% (P = 0.016) with hormone treatment. Despite this there was no difference in PSA progression-free survival at the last follow-up; it was 51.5% for those undergoing radical prostatectomy only and 49.8% for those who received hormonal pretreatment (P = 0.588). CONCLUSIONS: Three months of neoadjuvant hormonal therapy before radical prostatectomy offers no benefit to the patient and cannot be recommended for routine clinical use.
|
https://pubmed.ncbi.nlm.nih.gov/12230618/
|
[
"Clinical Trial",
"Journal Article",
"Multicenter Study",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12230618
|
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12,230,818 |
The scheduled ovarian hyperstimulation method makes it easy to perform ICSI with fresh testicular sperm (ICSI/TESE).
|
Nakagawa K K, Yamano S S, Tsutsumi Y Y, Matsumoto M M, Hinokio K K, Irahara M M, Aono T T, Naroda T T, Kagawa S S
|
Archives of andrology . Vol. 48, No. 5
|
The authors evaluated whether scheduled ovarian stimulation makes it easy to perform ICSI with fresh testicular sperm. Scheduled ovarian hyperstimulation was applied for testicular sperm extraction and ICSI with fresh testicular spermatozoa. Fifteen cycles in 10 couples were included in the present study; all couples were azoospermic, 5 were obstructive, and the remaining 5 were nonobstructive. No cycles were canceled, and all oocyte retrievals were performed on the scheduled day. Testicular sperm were obtained in 14 treatment cycles (93%). The mean numbers of retrieved and injected oocytes were 9.4 and 6.4, respectively. The fertilization and cleavage rates were 47 and 91%, respectively. Embryo transfers were performed in 12 cycles except 2 cycles that had no embryos. The number of transferred embryos was 2.3. Two clinical pregnancies were obtained. This scheduled ovarian hyperstimulation was applicable for ICSI with fresh testicular sperm.
|
https://pubmed.ncbi.nlm.nih.gov/12230818/
|
[
"Clinical Trial",
"Journal Article"
] |
12230818
|
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12,230,901 |
A pilot study of functional magnetic resonance imaging of the brain during manual and electroacupuncture stimulation of acupuncture point (LI-4 Hegu) in normal subjects reveals differential brain activation between methods.
|
Kong Jian J, Ma Lin L, Gollub Randy L RL, Wei Jinghan J, Yang Xuizhen X, Li Dejun D, Weng Xuchu X, Jia Fucang F, Wang Chunmao C, Li Fuli F, Li Ruiwu R, Zhuang Ding D
|
Journal of alternative and complementary medicine (New York, N.Y.) . Vol. 8, No. 4, 2002 Aug
|
OBJECTIVES: To characterize the brain activation patterns evoked by manual and electroacupuncture on normal human subjects. DESIGN: We used functional magnetic resonance imaging (fMRI) to investigate the brain regions involved in electroacupuncture and manual acupuncture needle stimulation. A block design was adopted for the study. Each functional run consists of 5 minutes, starting with 1-minute baseline and two 1-minute stimulation, the interval between the two stimuli was 1 minute. Four functional runs were performed on each subject, two runs for electroacupuncture and two runs for manual acupuncture. The order of the two modalities was randomized among subjects. During the experiment, acupuncture needle manipulation was performed at Large Intestine 4 (LI4, Hegu) on the left hand. For each subject, before scanning started, the needle was inserted perpendicular to the skin surface to a depth of approximately 1.0 cm. Electroacupuncture stimulation was delivered using a continuous rectangular wave form (pulse width 30 ms) at a frequency of 3 Hz. For manual acupuncture, the needle was rotated manually clockwise and counterclockwise at a rate of about 180 times per minute (3 Hz). SUBJECTS: Eleven right-handed, normal, healthy volunteer adults, 6 male and 5 female, ages 21-64 participated in the experiment. RESULTS: Results showed that electroacupuncture mainly produced fMRI signal increases in precentral gyrus, postcentral gyrus/inferior parietal lobule, and putamen/insula; in contrast, manual needle manipulation produced prominent decreases of fMRI signals in posterior cingulate, superior temporal gyrus, putamen/insula. CONCLUSION: These results indicate that different brain networks are involved during manual and electroacupuncture stimulation. It suggests that different brain mechanisms may be recruited during manual and electroacupuncture.
|
https://pubmed.ncbi.nlm.nih.gov/12230901/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12230901
|
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] |
12,230,903 |
Can the Q Link Ally, a form of Sympathetic Resonance Technology (SRT), attenuate acute mobile phone-related changes to neural function?
|
Croft Rodney J RJ, Chandler Jody S JS, Burgess Adrian P AP, Barry Robert J RJ, Williams John D JD, Clarke Adam R AR
|
Journal of alternative and complementary medicine (New York, N.Y.) . Vol. 8, No. 4, 2002 Aug
|
OBJECTIVES: Exposure to active mobile phones (MP) has been shown to affect human neural function as shown by the electroencephalogram (EEG). Although it has not been determined whether such effects are harmful, a number of devices have been developed that attempt to minimize these MP-related effects. One such device, the Q Link Ally (QL; Clarus Products, International, L.L.C., San Rafael, CA), is argued to affect the human organism in such a way as to attenuate the effect of MPs. The present pilot study was designed to determine whether there is any indication that QL does alter MP-related effects on the human EEG. DESIGN: Twenty-four (24) subjects participated in a single-blind, fully counterbalanced crossover design in which subjects' resting EEG and phase-locked neural responses to auditory stimuli were assessed under conditions of either active MP or active MP plus QL. RESULTS: The addition of QL to the MP condition increased resting EEG in the gamma range and did so as a function of exposure duration, and it attenuated MP-related effects in the delta and alpha range (at trend-level). The addition of the QL also affected phase-locked neural responses, with a laterality reversal in the alpha range and an alteration to changes over time in the delta range, a reduction of the MP-related beta decrease over time at fronto-posterior sites, and a global reduction in the gamma range that increased as a function of exposure duration. No unambiguous relations were found between these changes and either performance or psychologic state. CONCLUSIONS: This pilot study suggests that the addition of the QL to active MP-exposure does affect neural function in humans, altering both resting EEG patterns and the evoked neural response to auditory stimuli, and that there is a tendency for some MP-related changes to the EEG to be attenuated by the QL.
|
https://pubmed.ncbi.nlm.nih.gov/12230903/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12230903
|
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] |
12,230,933 |
Response and relapse rates of candidal esophagitis in HIV-infected patients treated with caspofungin.
|
Dinubile Mark J MJ, Lupinacci Robert J RJ, Berman Rayanne S RS, Sable Carole A CA
|
AIDS research and human retroviruses . Vol. 18, No. 13, 2002 Sep 01
|
Caspofungin is a new antifungal drug of the echinocandin class. We analyzed the clinical efficacy of caspofungin (50 mg/day) in the treatment of HIV-infected adults with endoscopically documented Candida esophagitis and enrolled in four clinical trials of caspofungin. Symptoms were evaluated daily; a favorable outcome required complete resolution of all esophageal symptoms assessed at the time of discontinuation of therapy. Relapse was defined as recurrent symptoms during the subsequent 2 weeks. A multivariate logistic regression model was developed to identify potential factors (including severity of symptoms at presentation, CD4(+) cell count on entry, extent of disease [assessed endoscopically at baseline], causative Candida species, duration of therapy [overall and after resolution of symptoms], time on treatment before symptom resolution, and antifungal prophylaxis) that might predict symptomatic relapse in the 2 weeks following completion of therapy. The median CD4(+) lymphocyte count for the entire population was 31/mm(3). Candida albicans was isolated from 109 of 110 patient samples cultured for the pathogen and constituted the sole isolate in 77%. Extensive esophageal involvement was present in 55% of patients at the time of pretreatment endoscopy. The duration of therapy ranged from 7 to 20 days (median, 12 days). Symptoms resolved in 117 of 123 patients (95%; 95% confidence interval, 90-98%) with a median time of ~4 days. Response rates were 43 of 46 (93%) and 70 of 73 (96%) for patients with greater or fewer than 50 CD4(+) cells/mm(3), and 80 of 85 (94%) and 23 of 24 (96%) in infections caused by C. albicans alone or in association with non-albicans isolates, respectively. Symptoms recurred within 2 weeks of stopping caspofungin in 19 of 115 evaluable patients (17%), including 3 of 16 (19%) receiving antifungal prophylaxis. Relapse rates were similar for patients with greater or fewer than 50 CD4(+) cells/mm(3). In this relatively small number of patients, only symptom severity and extent of disease judged endoscopically at baseline were significantly (p < 0.10) associated with early relapse in the multivariate model.
|
https://pubmed.ncbi.nlm.nih.gov/12230933/
|
[
"Clinical Trial",
"Clinical Trial, Phase II",
"Clinical Trial, Phase III",
"Journal Article",
"Randomized Controlled Trial"
] |
12230933
|
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] |
12,231,028 |
The effects of support groups on caregivers of patients with schizophrenia.
|
Chou Kuei-Ru KR, Liu Su-Yen SY, Chu Hsin H
|
International journal of nursing studies . Vol. 39, No. 7, 2002 Sep
|
The purpose of this study was to assess the effects of support groups on caregivers of patients with schizophrenia. This was a time series nonequivalent control group design. Subjects were evaluated in three waves of data collection: before intervention, after intervention and one-month follow-up. The support group's effects were measured using changes in the subjects' perceived levels of burden, depression status and satisfaction about their participation in the program. Professionally led support group had a close and time-limited format. The GEE (generalized estimated equation) revealed differences in caregivers' level of burden and depression status between the support and control groups in the post-test and one-month follow-up. The differences highlighted the fact that participation in support groups provides more effective assistance to caregivers than the control group.
|
https://pubmed.ncbi.nlm.nih.gov/12231028/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12231028
|
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] |
12,231,030 |
Reasons for physically restraining patients and residents: a systematic review and content analysis.
|
Evans David D, FitzGerald Mary M
|
International journal of nursing studies . Vol. 39, No. 7, 2002 Sep
|
OBJECTIVE: The purpose of this systematic review was to determine why people are physically restrained in the acute and residential care settings. METHOD: A comprehensive search was undertaken of electronic databases to identify studies addressing the reasons for using physical restraint. Findings were synthesised using content analysis. RESULTS: Twenty-three studies were identified. The most common reason for using restraints related to patient-oriented issues such as ensuring the safety of people. However, they are also commonly used to facilitate treatment, maintain the social environment and because of issues such as understaffing.
|
https://pubmed.ncbi.nlm.nih.gov/12231030/
|
[
"Journal Article",
"Review",
"Systematic Review"
] |
12231030
|
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0.5581733584403992,
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-0.2238125205039978,
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-0.1280139833688736,
0.45724472403526306,
0.21935513615608215,
0.10834275186061859,
-0.034817103296518326,
0.08468189835548401,
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] |
12,231,081 |
Comparison of one-year outcomes following coronary artery stenting in diabetic versus nondiabetic patients (from the Enhanced Suppression of the Platelet IIb/IIIa Receptor With Integrilin Therapy [ESPRIT] Trial).
|
Labinaz Marino M, Madan Mina M, O'Shea J O'Conor JO, Kilaru Rakhi R, Chin Wai W, Pieper Karen K, McGuire Darren K DK, Saucedo Jorge F JF, Talley J David JD, Lui Henry H, Kitt Michael M MM, Califf Robert M RM, Tcheng James T JT,
|
The American journal of cardiology . Vol. 90, No. 6, 2002 Sep 15
|
For patients undergoing nonurgent coronary stent implantation, blockade of the glycoprotein IIb/IIIa receptor with eptifibatide reduces the incidence of ischemic complications. We evaluated the interaction of eptifibatide with diabetes in patients who underwent this procedure by analyzing the 1-year outcomes of those enrolled in the Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial (466 diabetic and 1,595 nondiabetic patients). At 1 year, the composite end point of death, myocardial infarction (MI), or target vessel revascuarlization (TVR) was higher in diabetic patients (24.5% vs 18.4%; p = 0.008). At 1 year, eptifibatide had a similar effect on the composite end point of death, MI, or TVR in diabetic (hazards ratio [HR] 0.71, 95% confidence interval [CI] 0.49 to 1.04) and nondiabetic patients (HR 0.80, 95% CI 0.63 to 0.99). A similar treatment effect was also seen on death or MI in both groups. The 1-year mortality rate for diabetic patients assigned to placebo was 3.5% versus 1.3% for patients receiving eptifibatide (HR 0.37, 95% CI 0.10 to 1.41); the latter rate was similar to the mortality rate of 1.4% for nondiabetic patients in the eptifibatide group. However, eptifibatide did not have a significant effect on TVR in diabetic patients (HR 0.90, 95% CI 0.57 to 1.41). Our data suggest that treatment with eptifibatide is associated with a similar relative reduction in adverse ischemic complications in diabetic and nondiabetic patients undergoing coronary stent implantation. There is no evidence of a statistical interaction in the treatment effect of eptifibatide between patients with and without diabetes.
|
https://pubmed.ncbi.nlm.nih.gov/12231081/
|
[
"Clinical Trial",
"Comparative Study",
"Evaluation Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12231081
|
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] |
12,231,083 |
Effects of furosemide versus captopril on postprandial and orthostatic blood pressure and on cerebral oxygenation in patients > or = 70 years of age with heart failure.
|
Mehagnoul-Schipper D Jannet DJ, Colier Willy N J M WN, Hoefnagels Willibrord H L WH, Verheugt Freek W A FW, Jansen René W M M RW
|
The American journal of cardiology . Vol. 90, No. 6, 2002 Sep 15
|
Elderly patients with heart failure are at risk of postprandial hypotension (PPH), orthostatic hypotension (OH), and concomitant cerebral oxygenation changes because of altered cardiovascular balance and the use of cardiovascular medications, such as furosemide and captopril. In 24 patients with heart failure (New York Heart Association class II to III, in stable condition, and receiving cardiovascular medication [aged 70 to 83 years]), blood pressure (BP) was measured by Finapres, and cortical concentrations of oxyhemoglobin and deoxyhemoglobin were measured using near-infrared spectroscopy during standing and after a 292-kcal carbohydrate meal. Tests were performed before and during therapy with furosemide 40 mg once daily (n = 11) or captopril 6.25 and 12.5 mg twice daily (n = 13) in a double-blind randomized trial. Before treatment, 13 of 24 patients had PPH, and 2 of 24 patients had OH. The first dose of furosemide significantly decreased postprandial systolic BP (p <0.05) and postprandial frontal cortical oxygenation (p <0.05), whereas the first dose of captopril did not. Furosemide and captopril did not significantly affect postprandial or orthostatic BP or cortical oxygenation after 2 weeks of treatment. Thus, PPH is a common phenomenon in elderly patients with heart failure, whereas OH is not. The first dose of furosemide 40 mg decreased postprandial systolic BP and frontal cortical oxygenation, in contrast with the first dose of captopril 6.25 mg and 2-week treatment with furosemide 40 mg once daily or captopril 12.5 mg twice daily. These findings indicate that initiating furosemide treatment worsens PPH, and furosemide is less safe in elderly patients with heart failure.
|
https://pubmed.ncbi.nlm.nih.gov/12231083/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12231083
|
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] |
12,231,276 |
Modified pressure distribution patterns in walking following reduction of plantar sensation.
|
Eils Eric E, Nolte Stefan S, Tewes Markus M, Thorwesten Lothar L, Völker Klaus K, Rosenbaum Dieter D
|
Journal of biomechanics . Vol. 35, No. 10, 2002 Oct
|
The aim of the present study was to investigate the influence of reduced plantar sensation on pressure distribution patterns during gait of 40 healthy subjects (25.3+/-3.3 yr, 70.8+/-10.6 kg and 176.5+/-7.8 cm) with no history of sensory disorders. Plantar sensation in the subjects was reduced by using an ice immersion approach, and reduced sensitivity was tested with Semmes-Weinstein monofilaments. All subjects performed six trials of barefoot walking over a pressure distribution platform under normal as well as iced conditions. Plantar cutaneous sensation was significantly reduced after the cooling procedure (p<0.0001). Pressure distribution analysis showed substantially modified plantar pressure distribution patterns during the roll-over process (ROP) under iced conditions. Analysis of peak pressures revealed significant reductions under the toes and under the heel (p<0.001). The contact time and the relative impulse for the whole foot did not change significantly between the two conditions. For the different areas, a significant load shift from the heel and toes towards the central and lateral forefoot and the lateral midfoot was observed. The results indicate the strong influence of reduced afferent information of the sole of the foot on the ROP in walking.
|
https://pubmed.ncbi.nlm.nih.gov/12231276/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article"
] |
12231276
|
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] |
12,231,282 |
Inter-individual variations in wall shear stress and mechanical stress distributions at the carotid artery bifurcation of healthy humans.
|
Zhao S Z SZ, Ariff B B, Long Q Q, Hughes A D AD, Thom S A SA, Stanton A V AV, Xu X Y XY
|
Journal of biomechanics . Vol. 35, No. 10, 2002 Oct
|
Fluid shear stress and mechanical wall stress may play a role in the formation of early atherosclerotic lesions, but these quantities are difficult to measure in vivo. Our objective was to quantify these parameters in normal subjects in a clinical setting, and to define regions of low wall shear stress and high mechanical stress. The right carotid bifurcations of five healthy male volunteers were investigated using a novel non-invasive technique which integrates magnetic resonance angiography, ultrasonography, tonometry and state-of-the-art computational fluid dynamics and solid mechanics models. Significant inter-subject variations in patterns as well as magnitude of wall shear stress and mechanical stress were found. In spite of individual variabilities, this study revealed that some regions of the artery wall are exposed simultaneously to low wall shear stress and high mechanical stress and that these regions correspond to areas where atherosclerotic plaque develops. The coexistence of regions of low wall shear stress and high tensile stress may be an important determinant of the formation of atheroma in human arteries.
|
https://pubmed.ncbi.nlm.nih.gov/12231282/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12231282
|
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] |
12,231,281 |
A dynamic 3D biomechanical evaluation of the load on the low back during different patient-handling tasks.
|
Skotte J H JH, Essendrop M M, Hansen A F AF, Schibye B B
|
Journal of biomechanics . Vol. 35, No. 10, 2002 Oct
|
The objective of this study was to investigate the low-back loading during common patient-handling tasks. Ten female health care workers without formal training in patient handling performed nine patient-handling tasks including turning, lifting and repositioning a male stroke patient. The low-back loading was quantified by net moment, compression, and shear forces at the L4/L5 joint, measured muscle activity (EMG) in erector spinae muscles and rate of perceived exertion (RPE; Borg scale). The experiments were videotaped with a 50Hz video system using five cameras, and the ground and bedside reaction forces of the health care worker were recorded by means of force platforms and force transducers on the bed. The biomechanical load was calculated using a dynamic 3D seven-segment model of the lower part of the body, and the forces at the L4/L5 joint were estimated by a 14 muscles cross-sectional model of the low back (optimisation procedure). Compression force and torque showed high task dependency whereas the EMG data and the RPE values were more dependent on the subject. The peak compression during two tasks involving lifting the patient (4132/4433N) was significantly higher than all other tasks. Four tasks involving repositioning the patient in the bed (3179/3091/2932/3094N) did not differ, but showed higher peak compression than two tasks turning the patient in the bed (1618/2197N). Thus, in this study the patient-handling tasks could be classified into three groups-characterised by lifting, repositioning or turning-with different levels of peak net torque and compression at the L4/L5 joint.
|
https://pubmed.ncbi.nlm.nih.gov/12231281/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article"
] |
12231281
|
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] |
12,231,305 |
Hyperopic laser in situ keratomileusis for refractive accommodative esotropia.
|
Hoyos Jairo E JE, Cigales Melania M, Hoyos-Chacón Jairo J, Ferrer Jorge J, Maldonado-Bas Arturo A
|
Journal of cataract and refractive surgery . Vol. 28, No. 9, 2002 Sep
|
PURPOSE: To assess the efficacy of hyperopic laser in situ keratomileusis (LASIK) in creating orthophoria without optical correction in adult patients with refractive accommodative esotropia (RAE). SETTING: Instituto Oftalmológico de Sabadell, Sabadell, Barcelona, Spain. METHODS: This prospective single-center clinical trial studied 9 eyes (18 patients) with RAE having hyperopic LASIK. The mean follow-up was 20 months (range 12 to 24 months). The mean preoperative refraction was +5.01 diopters (D) and the mean deviation angle without optical correction, 36 prism diopters. The intervention was hyperopic LASIK using the Automated Corneal Shaper microkeratome (Bausch & Lomb) and the Apollo broad-beam excimer laser using a 5.5 mm optical zone and an 8.0 mm transition zone; astigmatism was treated by steepening the flattest meridian. RESULTS: All patients achieved orthophoria or the preoperative microtropia without optical correction immediately after surgery. This was maintained throughout the follow-up. Fifty-six percent of all cases were within +/-0.5 D of emmetropia, and 89% were within +/-1.0 D. The uncorrected visual acuity improved significantly (P <.005), especially at near, and the mean best corrected visual acuity (BCVA) was maintained, although 4 eyes (22%) lost 1 line of BCVA. There were no significant complications. CONCLUSIONS: In adult patients with RAE, treatment of the refractive error using hyperopic LASIK was safe and effective and corrected the esodeviation. Further studies in younger patients will help determine the age at which this intervention may be indicated.
|
https://pubmed.ncbi.nlm.nih.gov/12231305/
|
[
"Clinical Trial",
"Journal Article"
] |
12231305
|
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] |
12,231,310 |
Corneal endothelial cell protection during phacoemulsification: low- versus high-molecular-weight sodium hyaluronate.
|
Miyata Kazunori K, Maruoka Shinji S, Nakahara Masaaki M, Otani Shinichiro S, Nejima Ryohei R, Samejima Tomokazu T, Amano Shiro S
|
Journal of cataract and refractive surgery . Vol. 28, No. 9, 2002 Sep
|
PURPOSE: To compare the efficacy of low- and high-molecular-weight sodium hyaluronate in protecting corneal endothelial cells during phacoemulsification. SETTING: Miyata Eye Hospital, Miyakonojo, Miyazaki, Japan. METHODS: One hundred forty-nine eyes of 136 cataract patients were randomly assigned to have cataract surgery using sodium hyaluronate 1% with a low molecular weight (0.6 to 1.2 million d, Opegan) or sodium hyaluronate 1% with a high molecular weight (4 million d, Healon) during phacoemulsification. Each group was divided into 2 subgroups depending on the amount of ultrasound (% min) used during phacoemulsification, which was defined as the mean phacoemulsification energy (%) multiplied by phacoemulsification time (minutes). Corneal endothelial cell density was examined preoperatively and 3 months after surgery. The rate of cell loss was compared between the subgroups in the Opegan group and the Healon group. RESULTS: In the subgroups with ultrasound of 50% min or less, the mean rate of endothelial cell loss 3 months after surgery was 3.2% +/- 4.1% (SD) in the Opegan group and 5.9% +/- 5.3% in the Healon group (P =.0214). In the subgroups with ultrasound over 50% min, the mean rate of endothelial cell loss 3 months after surgery was 7.5% +/- 10.6% in the Opegan group and 14.8 +/- 9.0% in the Healon group (P =.0029). CONCLUSIONS: The results suggest that Opegan is more effective than Healon in protecting corneal endothelial cells during phacoemulsification regardless of the amount of ultrasound energy used.
|
https://pubmed.ncbi.nlm.nih.gov/12231310/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial"
] |
12231310
|
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12,231,311 |
Healon5: comparison of 2 removal techniques.
|
Zetterström Charlotta C, Wejde Gisela G, Taube Mikaela M
|
Journal of cataract and refractive surgery . Vol. 28, No. 9, 2002 Sep
|
PURPOSE: To evaluate the effect on intraocular pressure (IOP) of the rock 'n roll and behind-the-lens techniques of removing Healon(R)5 (sodium hyaluronate 2.3%). SETTING: St. Erik's Eye Hospital, Stockholm, Sweden. METHODS: In a prospective randomized study of 159 patients, 2 techniques to remove Healon5--rock 'n roll and behind-the-lens--were compared during cataract surgery. Cataract surgery included identical phacoemulsification performed by 1 surgeon and implantation of a silicone intraocular lens (IOL) in the capsular bag. The removal time of Healon5 was recorded. The IOP was measured preoperatively and 5 and 24 hours postoperatively. RESULTS: The mean IOP before surgery was 15.7 mm Hg +/- 2.8 (SD) in the rock 'n roll group and 15.9 +/- 2.7 mm Hg in the behind-the-lens group. Five hours postoperatively, the mean IOP was 25.6 +/- 10.4 mm Hg and 22.4 +/- 7.6 mm Hg, respectively; the difference between the groups was statistically significant. By 24 hours postoperatively, the mean IOP was at preoperative levels in both groups. The mean removal time of Healon5 was 50 seconds in the rock 'n roll group and 39 seconds in the behind-the-lens group; the difference between the groups was statistically significant. CONCLUSIONS: Results indicate that the behind-the-lens technique for removing Healon5 is quicker and safer than the rock 'n roll technique.
|
https://pubmed.ncbi.nlm.nih.gov/12231311/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial"
] |
12231311
|
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] |
12,231,315 |
Comparison of sonic and ultrasonic phacoemulsification using the Staar Sonic Wave system.
|
Hoffman Richard S RS, Fine I Howard IH, Packer Mark M, Brown Laurie K LK
|
Journal of cataract and refractive surgery . Vol. 28, No. 9, 2002 Sep
|
PURPOSE: To compare the performance of sonic phacoemulsification with that of ultrasonic phacoemulsification in regard to 1-day postoperative visual acuity, corneal edema, and procedure efficiency. SETTING: Oregon Eye Institute, Eugene, Oregon, USA. METHODS: This prospective nonrandomized study comprised 86 eyes with mild to moderate nuclear sclerotic cataract. Forty-three eyes had sonic and 43 ultrasonic phacoemulsification using the Staar Sonic Wave phacoemulsification system. The mean age was 76 years in the ultrasonic group and 71 years in the sonic group. The mean nuclear sclerosis was 2.0+ in the sonic group and 1.9+ in the ultrasonic group. Patient age, lens density, postoperative corneal edema, 1-day postoperative uncorrected visual acuity (UCVA), and the percentage of eyes with a visual acuity of 20/40 or better were determined. In addition, the mean ultrasonic and sonic times, mean percentage phaco power, and mean effective phaco time (EPT) were calculated in each group. RESULTS: Both groups had a 5% incidence of trace corneal edema. The mean UCVA was 20/41 in the ultrasonic group and 20/42 in the sonic group. Seventy-nine percent of eyes in the ultrasonic group and 74% in the sonic group had a UCVA of 20/40. The mean percentage phaco power was 7.2% and 7.6% in the ultrasonic group and sonic group, respectively. The mean EPT was low in both groups, 4.0 and 2.9 seconds, respectively. CONCLUSION: Sonic technology yielded outcomes similar to those of ultrasonic phacoemulsification with respect to postoperative visual acuity and corneal edema in patients with average density nuclear sclerotic cataract.
|
https://pubmed.ncbi.nlm.nih.gov/12231315/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article"
] |
12231315
|
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12,231,323 |
Effect of hydrodissection on intraoperative performance: randomized study.
|
Vasavada Abhay R AR, Singh Raminder R, Apple David J DJ, Trivedi Rupal H RH, Pandey Suresh K SK, Werner Liliana L
|
Journal of cataract and refractive surgery . Vol. 28, No. 9, 2002 Sep
|
PURPOSE: To evaluate the effect of hydrodissection on intraoperative performance during phacoemulsification of age-related nuclear cataracts. SETTING: Iladevi Cataract & IOL Research Centre, Ahmedabad, India, and Center for Research on Ocular Therapeutics and Biodevices, Storm Eye Institute, Medical University of South Carolina, Charleston, South Carolina, USA. METHODS: In a prospective study, 86 eyes were randomly assigned to have multiquadrant hydrodissection (+HD, n = 48) or no hydrodissection (-HD, n = 38) during phacoemulsification of a grade 1 to 3 nuclear cataract. Excluded were patients with grade 4 or 5 nuclear sclerosis, a poorly dilating pupil, or associated ocular/systemic disease. Parameters assessed were nucleus and cortex removal time, the amount of fluid used for cortex removal, and the total amount of fluid used. The ease of nucleus rotation and cortical cleanup was also evaluated and graded subjectively as very easy, difficult, or very difficult. Data were analyzed using the Student t test and the chi-square test. RESULTS: The mean nucleus removal time was 355 seconds +/- 237 (SD) and 474 +/- 212 seconds in the +HD and -HD groups, respectively (P =.09). The mean cortex removal time was significantly less in the +HD group than in the -HD group (79 +/- 51 seconds and 220 +/- 222 seconds, respectively) (P =.007). Significantly less fluid (43%) was used for cortex removal in the +HD group than in the -HD group (mean 70 +/- 45 mL and 123 +/- 82 mL, respectively) (P =.013), and significantly less total fluid (35%) was used in the +HD group (312 +/- 132 mL and 422 +/- 80 mL, respectively) (P =.002). Nucleus rotation was easy in all eyes in the +HD group; 68.43% of eyes in the -HD group failed to achieve rotation (P =.001). Cortex removal was very easy in 52.08% of eyes in the +HD group and easy in 47.90%; it was easy in 52.63% in the -HD group, difficult in 36.84%, and very difficult in 10.52%. CONCLUSION: The use of multiquadrant cortical-cleaving hydrodissection made removal of the lens nucleus and cortex easier and faster during phacoemulsification of age-related nuclear cataracts.
|
https://pubmed.ncbi.nlm.nih.gov/12231323/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12231323
|
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] |
12,231,416 |
The absolute bioavailability of clodronate from two different oral doses.
|
Villikka K K, Perttunen K K, Rosnell J J, Ikävalko H H, Vaho H H, Pylkkänen L L
|
Bone . Vol. 31, No. 3, 2002 Sep
|
Clodronate (disodium clodronate tetrahydrate) is a bisphosphonate used in the treatment of hypercalcemia and osteolysis due to malignancy. Like all bisphosphonates, clodronate has low and variable oral bioavailability. The purpose of this study was to examine the absolute bioavailability of clodronate from two different oral doses. Thirty-one healthy young volunteers participated in this open, randomized, three-period, single-dose, cross-over study. The absolute bioavailability was calculated from the area under the serum clodronate-time curve in 48 h (AUC(0-48 h)) after administration of 800 or 1600 mg (Bonefos 400 mg capsules) of oral clodronate, or 30 mg (Bonefos 60 mg/mL infusion concentrate) of intravenous clodronate. The maximum concentration of clodronate in serum (C(max)), the time to maximum concentration (t(max)), the elimination half-life (t(1/2)), and the cumulative amount of clodronate excreted into urine in 48 h (Ae(0-48 h)) were also determined. The geometric mean of the absolute bioavailability of 800 mg of clodronate was 1.9% and that of 1600 mg 2.1%. The difference in the absolute bioavailability of these two doses was statistically nonsignificant. All treatments were well tolerated, and the AE profiles were similar in the different treatment groups. There were no serious adverse events during the study.
|
https://pubmed.ncbi.nlm.nih.gov/12231416/
|
[
"Clinical Trial",
"Clinical Trial, Phase I",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial"
] |
12231416
|
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] |
12,231,441 |
Unilateral trigeminal anaesthesia modifies postural control in human subjects.
|
Gangloff Pierre P, Perrin Philippe P PP
|
Neuroscience letters . Vol. 330, No. 2, 2002 Sep 20
|
The influence of trigeminal afferences on postural stabilization was tested. Twenty-seven subjects were recruited to evaluate the impact of trigeminal disturbance on orthostatic postural control before and after unilateral truncular anaesthesia of the mandibular nerve. Balance control quality was assessed using static posturography by means of statokinesigrams and lateral deviation. Postural control monitored by measuring the area covered by the centre of foot pressure decreases after anaesthesia in the eyes open condition. Postural deviation in the eyes closed condition was observed after anaesthesia in the controlateral side of anaesthesia. These data document the effects of trigeminal afferences on postural stabilization.
|
https://pubmed.ncbi.nlm.nih.gov/12231441/
|
[
"Clinical Trial",
"Journal Article"
] |
12231441
|
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] |
12,231,461 |
Brain metabolic effects of Neotrofin in patients with Alzheimer's disease.
|
Potkin Steven G SG, Alva Gustavo G, Keator David D, Carreon Danilo D, Fleming Kirsten K, Fallon James H JH
|
Brain research . Vol. 951, No. 1, 2002 Sep 27
|
Neotrofin, a reported inducer of CNS neurotrophic factor synthesis and release, with memory-enhancing activity and demonstrated restoration of age-induced memory deficits in animals, was tested in patients with mild to moderate Alzheimer's disease. Nineteen subjects were treated with 1 week of low-dose (150 mg per day) and 1 week of high-dose (500 or 1000 mg per day) Neotrofin. Cognitive composite scores demonstrated improvement in memory (F=9.6, P=0.0004), executive functioning (P=0.004), and attention (P=0.004). PET scanning was obtained before, after low, and after high dosing. The brain areas most affected were the cerebellum, and sensory and prefrontal cortices, where increases in GMR (Glucose Metabolic Rate) were observed. Increases and decreases were observed in the posterior superior temporal (BA 22), parahippocampal, inferior temporal (BA 37, 20), and fusiform gyri as well as the superior parietal lobule and postcentral gyrus. There were strong hemispheric differences, producing opposite metabolic effects in homologous brain regions. Subcortically, the posterior thalamic region, meso-pontine tegmentum, and tectum had increases in GMR on the left side. At the low dose, GMR was generally increased, but to a lesser degree. The brain areas subserving memory, attention and executive functions were significantly altered in GMR by Neotrofin; however, the directions of these changes were complex. There were significant correlations between improvement in memory and executive function in brain areas involved in circuits subserving these functions. Thus, Neotrofin appears to induce metabolic changes in brain regions involved in circuits underlying memory, attention, and executive functioning.
|
https://pubmed.ncbi.nlm.nih.gov/12231461/
|
[
"Clinical Trial",
"Journal Article",
"Research Support, U.S. Gov't, P.H.S."
] |
12231461
|
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] |
12,231,488 |
High-frequency oscillatory ventilation for acute respiratory distress syndrome in adults: a randomized, controlled trial.
|
Derdak Stephen S, Mehta Sangeeta S, Stewart Thomas E TE, Smith Terry T, Rogers Mark M, Buchman Timothy G TG, Carlin Brian B, Lowson Stuart S, Granton John J,
|
American journal of respiratory and critical care medicine . Vol. 166, No. 6, 2002 Sep 15
|
Observational studies of high-frequency oscillatory ventilation in adults with the acute respiratory distress syndrome have demonstrated improvements in oxygenation. We designed a multicenter, randomized, controlled trial comparing the safety and effectiveness of high-frequency oscillatory ventilation with conventional ventilation in adults with acute respiratory distress syndrome; 148 adults with acute respiratory distress syndrome (Pa(O2)/fraction of inspired oxygen <or= 200 mm Hg on 10 or more cm H2O positive end-expiratory pressure) were randomized to high-frequency oscillatory ventilation (n = 75) or conventional ventilation (n = 73). Applied mean airway pressure was significantly higher in the high-frequency oscillation group compared with the conventional ventilation group throughout the first 72 hours (p = 0.0001). The high-frequency oscillation group showed early (less than 16 hours) improvement in Pa(O2)/fraction of inspired oxygen compared with the conventional ventilation group (p = 0.008); however, this difference did not persist beyond 24 hours. Oxygenation index decreased similarly over the first 72 hours in both groups. Thirty-day mortality was 37% in the high-frequency oscillation group and was 52% in the conventional ventilation group (p = 0.102). The percentage of patients alive without mechanical ventilation at Day 30 was 36% and 31% in the high-frequency oscillation and conventional ventilation groups, respectively (p = 0.686). There were no significant differences in hemodynamic variables, oxygenation failure, ventilation failure, barotraumas, or mucus plugging between treatment groups. We conclude that high-frequency oscillation is a safe and effective mode of ventilation for the treatment of acute respiratory distress syndrome in adults.
|
https://pubmed.ncbi.nlm.nih.gov/12231488/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Multicenter Study",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12231488
|
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12,231,497 |
Randomized crossover trial of two treatments for sleep apnea/hypopnea syndrome: continuous positive airway pressure and mandibular repositioning splint.
|
Engleman Heather M HM, McDonald James P JP, Graham David D, Lello Glenn E GE, Kingshott Ruth N RN, Coleman Emma L EL, Mackay Thomas W TW, Douglas Neil J NJ
|
American journal of respiratory and critical care medicine . Vol. 166, No. 6, 2002 Sep 15
|
Mandibular repositioning splints (MRSs) and continuous positive airway pressure (CPAP) are used to treat the sleep apnea/hypopnea syndrome (SAHS). There are some data suggesting that patients with milder symptoms prefer MRS, but there are few comparative data on outcomes. Therefore, we performed a randomized crossover trial of 8 weeks of CPAP and 8 weeks of MRS treatment in consecutive new outpatients diagnosed with SAHS (apnea/hypopnea index [AHI] >or= 5/hour, and >or= 2 symptoms including sleepiness). Assessments at the end of both limbs comprised home sleep study, subjective ratings of treatment value, sleepiness, symptoms, and well-being, and objective tests of sleepiness and cognition. Forty-eight of 51 recruited patients completed the trial (12 women; age [mean +/- SD], 46 +/- 9 years; Epworth 14 +/- 4; median AHI, 22/hour; interquartile ratio [IQR], 11-43/hour). Significant (p <or= 0.01) differences between MRS and CPAP were observed for 7 of 21 variables (effect sizes, 0.3-0.6 SDs), all favoring CPAP, including AHI (15 +/- 16 and 8 +/- 6/hour, respectively), effectiveness rating, symptoms, Epworth (12 +/- 5 and 8 +/- 5, respectively), functional outcomes of sleepiness questionnaire, short-form 36 health survey mental component, and health transition scores. Objective sleepiness, cognitive performance, and preference for treatments were not different. In patients experiencing a mild form of the syndrome (AHI < 15, n = 18), symptoms, treatment efficacy and satisfaction, and subjective sleepiness were also better with CPAP than with MRS (effect sizes, 0.7-1.1 SDs). These results do not support these MRS devices as first-line treatment for sleepy patients with SAHS.
|
https://pubmed.ncbi.nlm.nih.gov/12231497/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12231497
|
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] |
12,231,498 |
Effect of vertical dimension on efficacy of oral appliance therapy in obstructive sleep apnea.
|
Pitsis Andrew J AJ, Darendeliler M Ali MA, Gotsopoulos Helen H, Petocz Peter P, Cistulli Peter A PA
|
American journal of respiratory and critical care medicine . Vol. 166, No. 6, 2002 Sep 15
|
The aim of this study was to assess the effect of bite opening induced by a mandibular advancement splint (MAS) on efficacy and side effects in the treatment of obstructive sleep apnea. In a randomized crossover fashion, 23 adult patients received either MAS-1 (4 mm of interincisal opening) or MAS-2 (14 mm of interincisal opening) for 2 weeks, followed by the alternate treatment for 2 weeks, with an intervening 1-week washout. Complete response was defined as a resolution of symptoms and a reduction in apnea/hypopnea index (AHI) to less than 5 per hour. Partial response was defined as improved symptoms and a reduction in AHI of 50% or more, with the AHI remaining at a value of 5 or more per hour. Both MAS-1 and MAS-2 produced similar reductions in mean (+/- SEM) AHI from baseline: 21 +/- 2 versus 8 +/- 1/hour and 21 +/- 2 versus 10 +/- 2/hour, respectively (p < 0.001). Either complete response or partial response occurred in 74 and 61% of patients with MAS-1 and MAS-2, respectively. Subjective improvements were reported with both appliances by the majority of patients. Patients preferred MAS-1 (78 versus 22%, p = 0.007). This study suggests that the amount of bite opening induced by MAS does not have a significant impact on treatment efficacy but does have an impact on patient acceptance.
|
https://pubmed.ncbi.nlm.nih.gov/12231498/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12231498
|
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12,231,515 |
Increased uptake of the apoptosis-imaging agent (99m)Tc recombinant human Annexin V in human tumors after one course of chemotherapy as a predictor of tumor response and patient prognosis.
|
Belhocine Tarik T, Steinmetz Neil N, Hustinx Roland R, Bartsch Pierre P, Jerusalem Guy G, Seidel Laurence L, Rigo Pierre P, Green Allan A
|
Clinical cancer research : an official journal of the American Association for Cancer Research . Vol. 8, No. 9, 2002 Sep
|
PURPOSE: Many anticancer therapies exert their therapeutic effect by inducing apoptosis in target tumors. We evaluated in a Phase I study the safety and the feasibility of (99m)Tc-Annexin V for imaging chemotherapy-induced apoptosis in human cancers immediately after the first course of chemotherapy. EXPERIMENTAL DESIGN: Fifteen patients presenting with lung cancer (n = 10), lymphoma (n = 3), or breast cancer (n = 2) underwent (99m)Tc-Annexin V scintigraphy before and within 3 days after their first course of chemotherapy. Tumor response was evaluated by computed tomography and (18)F-fluoro-2-deoxy-D-glucose positron emission tomography scans, 3 months in average after completing the treatment. Median follow-up was 117 days. RESULTS: In all cases, no tracer uptake was observed before treatment. However, 24-48 h after the first course of chemotherapy, 7 patients who showed (99m)Tc-Annexin V uptake at tumor sites, suggesting apoptosis, had a complete (n = 4) or a partial response (n = 3). Conversely, 6 of the 8 patients who showed no significant posttreatment tumor uptake had a progressive disease. Despite the lack of tracer uptake after treatment, the 2 patients with breast cancer had a partial response. Overall survival and progression-free survival were significantly related to tracer uptake in treated lung cancers and lymphomas (P < 0.05). No serious adverse events were observed. CONCLUSIONS: Our preliminary results demonstrated the feasibility and the safety of (99m)Tc-Annexin V for imaging apoptosis in human tumors after the first course of chemotherapy. Initial data suggest that early (99m)Tc-Annexin V tumor uptake may be a predictor of response to treatment in-patients with late stage lung cancer and lymphoma.
|
https://pubmed.ncbi.nlm.nih.gov/12231515/
|
[
"Clinical Trial",
"Clinical Trial, Phase I",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12231515
|
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12,231,516 |
Maintenance biotherapy for metastatic melanoma with interleukin-2 and granulocyte macrophage-colony stimulating factor improves survival for patients responding to induction concurrent biochemotherapy.
|
O'Day Steven J SJ, Boasberg Peter D PD, Piro Lawrence L, Kristedja Timothy S TS, Wang He-Jing HJ, Martin Maureen M, Deck Regina R, Ames Patricia P, Shinn Kelly K, Kim Hannah H, Fournier Patricia P, Gammon Guy G
|
Clinical cancer research : an official journal of the American Association for Cancer Research . Vol. 8, No. 9, 2002 Sep
|
PURPOSE: A prospective Phase II study of a novel maintenance biotherapy regimen after induction biochemotherapy was conducted in patients with metastatic melanoma in efforts to maintain responses and improve survival. EXPERIMENTAL DESIGN: Thirty-three patients with poor prognosis metastatic melanoma who achieved a partial response (PR) or stable disease (SD) to induction concurrent biochemotherapy were treated with chronic low-dose interleukin (IL)-2 and granulocyte macrophage-colony stimulating factor, and intermittent pulses of intermediate/high-dose decrescendo IL-2 over a 12-month period. The outcome of these patients was compared with a control group of patients at our institution who were treated recently with induction biochemotherapy and achieved a PR or SD. RESULTS: Five patients (15%) achieved a complete response, and 4 patients (12%) maintained SD for at least 6 months on maintenance biotherapy. The median progression-free survival (PFS) and overall survival (OS) were 8.1 months and 18.5 months, respectively, compared with historical controls, which were PFS 5.9 months (P = 0.0015) and OS 9.3 months (P = 0.0004). Administration of maintenance biotherapy was a significant predictor of PFS (P = 0.0008) and OS (P = 0.0001) in multivariate and matched-pair analyses (P = 0.002). The maintenance biotherapy regimen was well tolerated with no dose-limiting acute or cumulative toxicities. CONCLUSION: In this single institution study, maintenance biotherapy with IL-2 and granulocyte macrophage colony-stimulating factor in patients achieving PR or SD to induction biochemotherapy improved PFS and OS compared with historical controls. A larger multicenter Phase II trial has been initiated in an effort to confirm these results.
|
https://pubmed.ncbi.nlm.nih.gov/12231516/
|
[
"Clinical Trial",
"Clinical Trial, Phase II",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12231516
|
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] |
12,231,517 |
Safety and immunogenicity of a DNA vaccine encoding carcinoembryonic antigen and hepatitis B surface antigen in colorectal carcinoma patients.
|
Conry Robert M RM, Curiel David T DT, Strong Theresa V TV, Moore Susan E SE, Allen Karen O KO, Barlow Daunte L DL, Shaw Denise R DR, LoBuglio Albert F AF
|
Clinical cancer research : an official journal of the American Association for Cancer Research . Vol. 8, No. 9, 2002 Sep
|
Despite an abundance of preclinical data, relatively little is known regarding the efficacy of DNA vaccination in humans. Here, we present results from a dose-escalation clinical trial of a dual expression plasmid encoding carcinoembryonic antigen (CEA) and hepatitis B surface antigen (HBsAg) in 17 patients with metastatic colorectal carcinoma. CEA was selected as a prototypic tumor-associated self-antigen, and the HBsAg cDNA was included as a positive control for immune response to the DNA vaccine without relying upon breaking tolerance to a self-antigen. Groups of 3 patients received escalating single i.m. doses of the DNA vaccine at 0.1, 0.3, and 1.0 mg. Subsequent groups of 3 patients received three repetitive 0.3- or 1.0-mg doses at 3-week intervals. A final group of 2 patients received three repetitive 2.0 mg doses at 3-week intervals. Toxicity was limited to transient grade 1 injection site tenderness, fatigue, and creatine kinase elevations, each affecting a minority of patients in a non-dose-related manner. Repetitive dosing of the DNA vaccine induced HBsAg antibodies in 6 of 8 patients, with protective antibody levels achieved in four of these patients. CEA-specific antibody responses were not observed, but 4 of 17 patients developed lymphoproliferative responses to CEA after vaccination. No objective clinical responses to the DNA vaccine were observed among this population of patients with widely metastatic colorectal carcinoma. Nevertheless, this pilot trial has provided encouraging human immune response data in support of this vaccine technology.
|
https://pubmed.ncbi.nlm.nih.gov/12231517/
|
[
"Clinical Trial",
"Clinical Trial, Phase I",
"Journal Article",
"Research Support, U.S. Gov't, P.H.S."
] |
12231517
|
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12,231,518 |
Phase I and pharmacokinetic study of the new taxane analog BMS-184476 given weekly in patients with advanced malignancies.
|
Plummer Ruth R, Ghielmini Michele M, Calvert Paula P, Voi Maurizio M, Renard Josette J, Gallant Gilles G, Gupta Elora E, Calvert Hilary H, Sessa Cristiana C
|
Clinical cancer research : an official journal of the American Association for Cancer Research . Vol. 8, No. 9, 2002 Sep
|
PURPOSE: The study was designed to establish the maximum administered dose and maximum tolerated dose (MTD) of BMS-184476, an analogue of paclitaxel, given weekly for 3 consecutive weeks every 28 days, later amended to a regimen of weekly administration for 2 consecutive weeks every 21 days. EXPERIMENTAL DESIGN: Adult patients with solid tumors received BMS-184476 i.v. on days 1, 8, and 15 without premedication. The trial followed a modified accelerated titration design. Doses of 7, 14, 28, 40, 50, and 60 mg/m(2)/wk were investigated. Pharmacokinetics of BMS-184476 in plasma and urine were investigated by high-performance liquid chromatography assay. RESULTS: Fifty-three patients were treated; the maximum administered dose was 60 mg/m(2)/wk, and the MTD was 50 mg/m(2)/wk. Dose-limiting neutropenia was the main toxicity. Neutropenia at the higher dose levels frequently prevented administration of the day 15 dose, and a modified schedule at MTD dosing on days 1 and 8 every 21 days was evaluated and found more feasible for Phase II studies. Diarrhea was the main nonhematological toxicity; other toxicities were vomiting, cumulative fatigue, and loss of appetite. Two patients died of neutropenia-related complications. Antitumor activity was observed in patients with breast and non-small cell lung cancer, with confirmed partial responses in 22% of patients. BMS-184476 was the main species found in the plasma with <5% present as paclitaxel or sulfoxide metabolites. The PKs of BMS-184476 appeared to be linear in the dose range of 7-60 mg/m(2). CONCLUSION: The recommended dose and schedule of weekly BMS-184476 is 50 mg/m(2) on days 1 and 8 every 21 days.
|
https://pubmed.ncbi.nlm.nih.gov/12231518/
|
[
"Clinical Trial",
"Clinical Trial, Phase I",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12231518
|
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12,231,519 |
Results of a Phase I dose-escalating study of the antiangiogenic agent, SU5416, in patients with advanced malignancies.
|
Stopeck Alison A, Sheldon Marrae M, Vahedian Mahmood M, Cropp Gillian G, Gosalia Rishi R, Hannah Alison A
|
Clinical cancer research : an official journal of the American Association for Cancer Research . Vol. 8, No. 9, 2002 Sep
|
SU5416 is a small molecule antiangiogenic agent that inhibits vascular endothelial growth factor (VEGF) stimulation of the KDR tyrosine kinase receptor. In this Phase I dose escalation trial, a weekly dose schedule of SU5416 was tested whereby an initial 5-day loading dose was followed by weekly maintenance infusions. The start dose was 20 mg/m(2) for the loading dose followed by 65 mg/m(2) for the weekly infusions. Dose escalations occurred at 33% until a final dose of 65 mg/m(2) (loading dose) and 190 mg/m(2) (weekly infusion) was obtained. Twenty-two patients were treated at five dose levels; tumor types included gastrointestinal (8), breast (3), lung (4), sarcoma (2), and other (5). The most common serious drug-related toxicity was headache, often associated with nausea and vomiting. Grade 1 and 2 toxicities included headache, nausea, vomiting, asthenia, pain at the infusion site, phlebitis, change in voice, and fevers. Of 19 evaluable patients, 4 obtained clinical benefit as defined by tumor regression (1) or disease stabilization for at least 12 weeks (3). Pharmacokinetic data revealed that the weekly infusion schedule prevented the reported 50-60% induction in SU5416 clearance observed with either daily or twice weekly dosing. Higher baseline levels of urine VEGF were observed in the 4 patients who gained clinical benefit, suggesting this may be a useful marker for predicting response to anti-VEGF therapies. Our results suggest that a weekly schedule of SU5416 shows signs of biological activity and is well tolerated at doses up to 145 mg/m(2).
|
https://pubmed.ncbi.nlm.nih.gov/12231519/
|
[
"Clinical Trial",
"Clinical Trial, Phase I",
"Journal Article"
] |
12231519
|
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12,231,520 |
A Phase I study of combined modality (90)Yttrium-CC49 intraperitoneal radioimmunotherapy for ovarian cancer.
|
Alvarez Ronald D RD, Huh Warner K WK, Khazaeli M B MB, Meredith Ruby F RF, Partridge Edward E EE, Kilgore Larry C LC, Grizzle William E WE, Shen Sui S, Austin J Max JM, Barnes Mack N MN, Carey Delicia D, Schlom Jeffrey J, LoBuglio Albert F AF
|
Clinical cancer research : an official journal of the American Association for Cancer Research . Vol. 8, No. 9, 2002 Sep
|
PURPOSE: The purpose of this study was to determine the feasibility and maximum tolerated dose of (90)Yttrium-CC49 ((90)Y-CC49) as the radioimmunotherapy (RIT) component of an i.p. combined modality treatment for recurrent ovarian cancer. EXPERIMENTAL DESIGN: A Phase I trial of (90)Y-CC49 RIT was conducted in ovarian cancer patients who had persistent or recurrent intra-abdominal disease, had failed one or two prior chemotherapy regimens, and demonstrated TAG-72 expression. Patients were treated with a previously established combined modality treatment protocol of s.c. IFN alpha2b, i.p. paclitaxel, and increasing dosages of i.p. (90)Y-CC49. Patients were monitored for toxicity, generation of human antimouse antibody response, and clinical efficacy. RESULTS: Twenty eligible patients were treated per study specifications. All patients had been treated with debulking and paclitaxel/carboplatin-based chemotherapy at initial diagnosis. The patients included 11 patients with persistent disease at the time of second look laparotomy and 9 patients with delayed recurrence. Patients were treated with i.p. (90)Y-CC49 given in combination with s.c. IFN alpha2b (dose of 3 x 10(6) units for a total of four doses) and i.p. paclitaxel (dose of 100 mg/m(2)). RIT treatment was associated with primarily hematological toxicity. The maximum tolerated dose of i.p. (90)Y-CC49 was established at 24.2 mCi/m(2) in this combined regimen. Of nine patients with measurable disease, two had partial responses lasting 2 and 4 months. Of 11 patients with nonmeasurable disease, median time to progression was 6 months in 7 patients who recurred; 4 of these patients remain no evidence of disease at 9+, 18+, 19+, and 23+ months. CONCLUSIONS: (90)Yttrium-CC49-based RIT in combination with IFN alpha2b and i.p. paclitaxel is feasible and well tolerated at a dose of < or =24.2 mCi/m(2).
|
https://pubmed.ncbi.nlm.nih.gov/12231520/
|
[
"Clinical Trial",
"Clinical Trial, Phase I",
"Journal Article",
"Research Support, U.S. Gov't, P.H.S."
] |
12231520
|
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12,231,521 |
Postremission therapy with low-dose interleukin 2 with or without intermediate pulse dose interleukin 2 therapy is well tolerated in elderly patients with acute myeloid leukemia: Cancer and Leukemia Group B study 9420.
|
Farag Sherif S SS, George Stephen L SL, Lee Edward J EJ, Baer Maria M, Dodge Richard K RK, Becknell Brian B, Fehniger Todd A TA, Silverman Lewis R LR, Crawford Jeffrey J, Bloomfield Clara D CD, Larson Richard A RA, Schiffer Charles A CA, Caligiuri Michael A MA
|
Clinical cancer research : an official journal of the American Association for Cancer Research . Vol. 8, No. 9, 2002 Sep
|
PURPOSE: The purpose of the study is to investigate the tolerability of interleukin 2 (IL-2) after intensive chemotherapy in elderly acute myeloid leukemia (AML) patients in first complete remission (CR). EXPERIMENTAL DESIGN: AML patients > or =60 years in CR after induction and consolidation chemotherapy on Cancer and Leukemia Group B study 9420 were eligible if they had neutrophils > or =1 x 10(9)/liters and platelets > or =75 x 10(9)/liters. Patients received low-dose IL-2 (1 x 10(6) IU/m(2)/day s.c. for 90 days) or low-dose IL-2 with intermediate pulse doses (6-12 x 10(6) IU/m(2)/day s.c. for 3 days) every 14 days (maximum five pulses). In a subset of patients, we investigated the expression of NKG2D ligands by leukemic cells because they are likely important mediators of natural killer cytotoxicity. RESULTS: Of 35 CR patients receiving IL-2, 34 were evaluable for toxicity. Median age was 67 (range, 60-76) years. Thirteen of 16 patients receiving low-dose IL-2 completed the planned therapy, and 11 of 18 who also received intermediate pulse dose IL-2 therapy completed all five pulses. The spectrum of toxicity in both groups was similar, with predominantly grade 1-2 fatigue, fever, injection site reactions, nausea, anemia, and thrombocytopenia. Grade 3-4 hematological and nonhematological toxicity were more frequent in patients also receiving intermediate pulse dose IL-2 therapy. Grade 3-4 fatigue and hematological toxicity, although uncommon, were the major causes for discontinuing or attenuating therapy. In 8 cases, mRNA for one or more NKG2D ligands was detected in leukemic cells obtained at diagnosis before treatment. CONCLUSIONS: Low-dose IL-2, with or without intermediate pulse dose therapy, given immediately after chemotherapy in first CR to elderly AML patients is well tolerated. Expression of NKG2D ligands by leukemic cells was detected in the majority of cases tested and should be assessed for correlation with response to IL-2 in future studies.
|
https://pubmed.ncbi.nlm.nih.gov/12231521/
|
[
"Clinical Trial",
"Clinical Trial, Phase I",
"Controlled Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, P.H.S."
] |
12231521
|
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] |
12,231,522 |
Phase I trial of 1alpha-hydroxyvitamin d(2) in patients with hormone refractory prostate cancer.
|
Liu Glenn G, Oettel Kurt K, Ripple Gregory G, Staab Mary Jane MJ, Horvath Dorothea D, Alberti Dona D, Arzoomanian Rhoda R, Marnocha Rebecca R, Bruskewitz Reginald R, Mazess Richard R, Bishop Charles C, Bhattacharya Abhik A, Bailey Howard H, Wilding George G
|
Clinical cancer research : an official journal of the American Association for Cancer Research . Vol. 8, No. 9, 2002 Sep
|
This Phase I study of 1alpha-hydroxyvitamin D(2), an p.o. administered vitamin D analogue, in patients with advanced hormone-refractory prostate cancer was designed to assess the toxicity, pharmacokinetic and biological markers of drug activity, and lastly tumor response data to recommend a dose for Phase II studies. 1alpha-Hydroxyvitamin D(2) was administered daily at doses ranging from 5 to 15 microg/day. Patients were monitored for toxicity and tumor response, and blood and urine samples were collected for pharmacokinetics (1alpha,25-dihydroxyvitamin D(2) levels) and other parameters of biological activity (bone markers, parathyroid hormone, urine calcium, and serum phosphorus levels). Twenty-five patients were enrolled. Main toxicities were hypercalcemia with associated renal insufficiency. No other significant toxicity was seen. Pharmacokinetics showed an increase in the active metabolite 1alpha,25-dihydroxyvitamin D(2) that reached a plateau by week 4 despite continuous drug dosing. Elevation in daily urinary calcium excretion and serum phosphorus levels was seen, whereas a decrease in serum parathyroid hormone was evident. Two patients showed evidence of a partial response, whereas 5 others achieved disease stabilization for > or =6 months. 1alpha-Hydroxyvitamin D(2) was well tolerated with main toxicities being hypercalcemia and renal insufficiency. All of the toxicity was reversible with drug discontinuation. Evidence for drug activity was seen in surrogate markers, and pharmacokinetic analysis showed substantial increases in vitamin D metabolite levels among the various cohorts. Whereas the defined maximum tolerated dose was not reached, the recommended Phase II dose was 12.5 microg/day given continuously.
|
https://pubmed.ncbi.nlm.nih.gov/12231522/
|
[
"Clinical Trial",
"Clinical Trial, Phase I",
"Comparative Study",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12231522
|
[
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] |
12,231,523 |
Phase I clinical trials of tezacitabine [(E)-2'-deoxy-2'-(fluoromethylene)cytidine] in patients with refractory solid tumors.
|
Rodriguez Gladys I GI, Jones Richard E RE, Orenberg Elaine K EK, Stoltz Maxine L ML, Brooks Donald J DJ
|
Clinical cancer research : an official journal of the American Association for Cancer Research . Vol. 8, No. 9, 2002 Sep
|
PURPOSE: To evaluate safety, tolerability, and pharmacokinetics of a new nucleoside analogue, tezacitabine [(E)-2'-deoxy-2'-(fluoromethylene)cytidine (FMdC)] in patients with refractory solid tumors. EXPERIMENTAL DESIGN: Seventy patients were enrolled in four separate Phase I trials. Patients had metastatic or relapsed cancer of the colon, breast, pancreas, gastrointestinal tract, lung, and other sites. FMdC was administered by i.v. infusion over 30 min in one of four dose schedules--from once every 3 weeks to twice a week for 3 weeks, with dose escalation in each. Maximum doses ranged from 630 to 16 mg/m(2). RESULTS: Myelotoxicity, especially neutropenia, was the dominant toxicity and was generally dose-related. Grade 3 or 4 neutropenia occurred in 53% of patients but was of relatively short duration (1-8 days) in all of the patients. One patient experienced grade 3 thrombocytopenia and one patient grade 4 (duration 15 and 11 days, respectively). Transient febrile episodes were reported in 82% of patients with drug administration but were easily controlled. Drug-related gastrointestinal events were mild and appeared unrelated to dose. Pharmacokinetics were linear with dose, not appreciably affected by schedules, and not different after single or multiple doses. Terminal half-life was 3-4 h, and 23% of the administered drug was recovered in the urine as unchanged drug. The uridine analogue (FMdU), the deaminated metabolite of FMdC, was the primary metabolite. Objective antitumor activity was observed in eight patients: one exhibited a partial response and seven exhibited stable disease. CONCLUSIONS: In general, FMdC was well tolerated. On the basis of the time to recovery from neutropenia, the recommended schedule for Phase II studies is one treatment every 2 weeks, at a minimum dose of 270 mg/m(2).
|
https://pubmed.ncbi.nlm.nih.gov/12231523/
|
[
"Clinical Trial",
"Clinical Trial, Phase I",
"Comparative Study",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12231523
|
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