Larger Patient Population (larger + patient_population)

Distribution by Scientific Domains


Selected Abstracts


Effect of Perilesional Injections of PEG-Interleukin-2 on Basal Cell Carcinoma

DERMATOLOGIC SURGERY, Issue 11 2000
Baruch Kaplan MD
Background: Multiple modalities are available for the treatment of basal cell carcinoma (BCC). The most commonly used modalities include simple excision, Mohs micrographic surgery, curettage and electrodessication, cryosurgery, and irradiation therapy. Interleukin-2 (IL-2) is a cytokine produced chiefly by activated T lymphocytes and has effects on various components of the immune system. Until now the primary clinical use of IL-2 has been in advanced stages of metastatic melanoma and renal cell carcinoma. Systemic administration of IL-2 is known to cause significant toxicity. Objective: The objective of this study was to evaluate the therapeutic efficacy and safety of perilesional PEG-IL-2 injections in patients with BCC in an open label, uncontrolled pilot study. Methods: Patients with histologically confirmed primary BCC over 18 years of age were included in the study. Lesions were treated by injecting a total volume of 0.5 cc of IL-2 in a radial fashion in the subcutaneous tissue. Injection dosages ranged from 3000 to 1,200,000 IU in one to four weekly dosages. A total of 12 tumors were treated in eight patients. Results: Overall response rates were as follows: complete response in 8 of 12 treated tumors (66.6% cure rate), partial response in 3 of 12 injected tumors (25% partial response rate), stable disease with no improvement in 1 treatment site (8.4%). Side effects included local pain, swelling, and erythema, and in one patient flulike symptoms. There were no significant changes of blood tests as compared to baseline levels. Conclusions: The therapeutic response induced by perilesional PEG-IL-2 injections was found to be an encouraging, safe, and well-tolerated treatment of BCC. Further studies including a larger patient population and long-term follow-up are necessary in order to substantiate these findings. [source]


T1, MRI quantification of arthroscopically confirmed cartilage degeneration

MAGNETIC RESONANCE IN MEDICINE, Issue 5 2010
Walter R. T. Witschey
Abstract Nine asymptomatic subjects and six patients underwent T1, MRI to determine whether Outerbridge grade 1 or 2 cartilage degeneration observed during arthroscopy could be detected noninvasively. MRI was performed 2-3 months postarthroscopy, using sagittal T1 -weighted and axial and coronal T1, MRI, from which spatial T1, relaxation maps were calculated from segmented T1 -weighted images. Median T1, relaxation times of patients with arthroscopically documented cartilage degeneration and asymptomatic subjects were significantly different (P < 0.001), and median T1, exceeded asymptomatic articular cartilage median T1, by 2.5 to 9.2 ms. In eight observations of mild cartilage degeneration at arthroscopy (Outerbridge grades 1 and 2), mean compartment T1, was elevated in five, but in all observations, large foci of increased T1, were observed. It was determined that T1, could detect some, but not all, Outerbridge grade 1 and 2 cartilage degeneration but that a larger patient population is needed to determine the sensitivity to these changes. Magn Reson Med 63:1376,1382, 2010. © 2010 Wiley-Liss, Inc. [source]


A Clinical Risk Score to Predict the Time to First Appropriate Device Therapy in Recipients of Implantable Cardioverter Defibrillators

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 3 2007
HAITHAM HREYBE M.D.
Background:To develop a risk score to predict the occurrence of appropriate defibrillator [implantable cardioverter-defibrillator (ICD)] therapies. A simple clinical score predicting the risk of appropriate ICD therapy is lacking. Methods:A Cox regression model was developed from a database of ICD patients at a single tertiary center to predict the time to appropriate ICD therapy defined as shock or antitachycardia pacing. A risk score was derived from this model using half of the database and was validated using the other half. Results:A total of 399 patients were entered into the database between July 2001 and February 2004. There were no statistically significant differences between the derivation (n = 200) and validation (n = 199) groups in any of the demographic or clinical variables recorded. The risk score included three independent variables: indication for ICD implantation (P = 0.03), serum creatinine level (P = 0.015), and QRS width (P = 0.028). The observed risk scores were highly predictive of time to ICD therapy in the validation group (P = 0.02). Conclusion:We describe a new clinical risk score that predicts the time to appropriate device therapy in ICD recipients of a single tertiary center hospital. The performance of this risk score needs to be investigated prospectively in a larger patient population. [source]


Molecular Breast Imaging: Advantages and Limitations of a Scintimammographic Technique in Patients with Small Breast Tumors

THE BREAST JOURNAL, Issue 1 2007
Michael K. O'Connor PhD
Abstract:, Preliminary studies from our laboratory showed that molecular breast imaging (MBI) can reliably detect tumors <2 cm in diameter. This study extends our work to a larger patient population and examines the technical factors that influence the ability of MBI to detect small breast tumors. Following injection of 740 MBq Tc-99m sestamibi, MBI was performed on 100 patients scheduled for biopsy of a lesion suspicious for malignancy that measured <2 cm on mammography or sonography. Using a small field of view gamma camera, patients were imaged in the standard mammographic views using light pain-free compression. Subjective discomfort, breast thickness, the amount of breast tissue in the detector field of view, and breast counts per unit area were measured and recorded. Follow-up was obtained in 99 patients; 53 patients had 67 malignant tumors confirmed at surgery. Of these, 57 of 67 were detected by MBI (sensitivity 85%). Sensitivity was 29%, 86%, and 97% for tumors <5, 6,10, and ,11 mm in diameter, respectively. In seven patients, MBI identified eight additional mammographically occult tumors. Of 47 patients with no evidence of cancer at biopsy or surgery, there were 36 true negative and 11 false positive scans on MBI. MBI has potential for the regular detection of malignant breast tumors less than 2 cm in diameter. Work in progress to optimize the imaging parameters and technique may further improve sensitivity and specificity. [source]


Prognostic value of lymph node ratio in poor prognosis node-positive breast cancer patients in Saudi Arabia

ASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY, Issue 2 2010
Ezzeldin M IBRAHIM
Abstract Aim: Women in Saudi Arabia develop breast cancer at a young age with high prevalence of poor prognostic features. Because of such features, it is necessary to examine prognostic factors in this population. One such factor is the prognostic role of lymph node ratio (LNR). Methods: We performed retrospective analyses of patients with invasive non-metastatic breast cancer who underwent axillary lymph node dissection and had one or more positive axillary lymph nodes. Results: Two hundred and seventeen patients were considered eligible for the analysis. The median age was 46 years. At a median follow-up of 39.8 months, the median disease-free survival (DFS) was 67.3 months (95% CI, 50.4 to 84.3 months). Neither the classification of patients based on positive lymph node (pN) staging system, nor the absolute number of pN prognosticated DFS. Conversely, age , 35 years at diagnosis, grade 3 tumors and the intermediate (>0.20 to ,0.65) and high (>0.65) LNR categories were the only variables that were independently associated with adverse DFS. Using these variables in a prognostic model allowed the classification of patients into three distinctive risk strata. The overall survival (OS) in this series was 92.5 months (95% CI, 92.1,92.6). Only ER negative tumor adversely influenced OS. Conclusion: Analysis of survival outcome of mostly young patients with early breast cancer identified adverse prognostic variables affecting DFS. If the utility of the derived model including LNR is proven in a larger patient population, it may replace the use of absolute number of positive axillary lymph nodes. [source]


Reticulated platelet counts correlate with treatment response in patients with idiopathic thrombocytopenic purpura and help identify the complex causes of thrombocytopenia in patients after allogeneic hematopoietic stem cell transplantation

CYTOMETRY, Issue 4 2007
Anna-Katharina Thomas-Kaskel
Abstract Background: In thrombocytopenic conditions of unknown origin, quantification of reticulated platelets (RP) in the peripheral blood by flow cytometry has been shown to differentiate increased platelet (Plt) turnover from insufficient Plt production. Methods: We used a whole blood flow cytometry method combining thiazole orange and anti-CD41a-staining to assess RP in 71 healthy subjects, six with thrombocytopenic myelodysplastic syndrome (MDS), nine with liver cirrhosis, 14 patients with idiopathic thrombocytopenic purpura (ITP), and 12 patients who had undergone hematopoietic stem cell transplantation (HSCT). Results: Patients with MDS had normal, patients with liver cirrhosis had slightly elevated RP counts compared to healthy subjects. ITP patients had elevated RP counts, and RP >15% were associated with treatment response (P = 0.015). In 7/10 patients after HSCT, an increase of RP preceded Plt recovery, whereas in patients with secondary thrombocytopenia after normal regeneration, the assessment of RP allowed the differentiation between conditions with high Plt turnover, such as GvHD and microangiopathy, indicated by high RP counts, and graft failure, indicated by low RP counts. Conclusions: Our data provide the rationale for prospective studies on the diagnostic and prognostic value of RP counts in larger patient populations with ITP and after HSCT. © 2007 Clinical Cytometry Society [source]


Efficacy of a standardized echinacea preparation (EchinilinTM) for the treatment of the common cold: a randomized, double-blind, placebo-controlled trial

JOURNAL OF CLINICAL PHARMACY & THERAPEUTICS, Issue 1 2004
V. Goel PhD
Summary Background:, Recently, echinacea has regained popularity as one of the treatments chosen most commonly by consumers with the expectation that it will reduce the severity and duration of the common cold. However, the results from a limited number of clinical trials for this application have thus far been inconclusive. This incongruity may be the result of investigators utilizing poorly standardized echinacea products, likely devoid of sufficient quantities of active constituents necessary to exert a definitive clinical effect. Therefore, a formulation containing alkamides, cichoric acid, and polysaccharides at concentrations of 0·25, 2·5, and 25 mg/mL, respectively, was prepared from freshly harvested Echinacea purpurea plants (commercially available as Echinilin, Natural Factors Nutritional Products, Inc., Vancouver, BC, Canada). The objective of this study was to test the efficacy of this highly standardized formulation in reducing the severity and duration of symptoms of a naturally acquired common cold. Methods:, In a randomized, double-blind, placebo-controlled trial, 282 subjects aged 18,65 years with a history of two or more colds in the previous year, but otherwise in good health, were recruited. The subjects were randomized to receive either echinacea or placebo. They were instructed to start the echinacea or placebo at the onset of the first symptom related to a cold, consuming 10 doses the first day and four doses per day on subsequent days for 7 days. Severity of symptoms (10-point scale: 0, minimum; 9, maximum) and dosing were recorded daily. A nurse examined the subjects on the mornings of days 3 and 8 of their cold. Results:, A total of 128 subjects contracted a common cold (59 echinacea, 69 placebo). The total daily symptom scores were found to be 23·1% lower in the echinacea group than in placebo in those who followed all elements of the study protocol (P < 0·01). Throughout the treatment period, the response rate to treatments was greater in the echinacea group. A few adverse event profiles were observed in both groups. Conclusions:, Early intervention with a standardized formulation of echinacea resulted in reduced symptom severity in subjects with naturally acquired upper respiratory tract infection. Further studies with larger patient populations appear to be warranted. [source]


Platelet Activation Markers in Patients With Heart Assist Device

ARTIFICIAL ORGANS, Issue 4 2005
Oliver Dewald
Abstract:, Clinical use of heart assist devices is often associated with thromboembolic complications. We hypothesized that platelets may be activated in patients receiving assist devices and examined expression of the platelet activation markers CD62, CD63, and thrombospondin using flow cytometry in eight patients with Novacor left ventricular assist system (LVAS) or Berlin Heart. Patients with end-stage heart failure had elevated expression of platelet activation markers before insertion of the assist device. While CD62 (P < 0.05) and thrombospondin expression (n.s.) decreased by the 14th postoperative day, the CD63 expression remained elevated (n.s.). A good correlation was found between CD62 and thrombospondin expression (r = 0.72). Bleeding time ex vivo indicated platelet dysfunction during the first 4 weeks after implantation. No relation between expression of platelet activation markers and bleeding time ex vivo were found. In conclusion, expression of the platelet activation markers CD62, CD63, and thrombospondin is increased in patients with end-stage heart failure before device placement and shows prolonged elevation during the assist period. Future studies in larger patient populations are necessary to identify new and specific markers of platelet activation in this clinical setting. [source]