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Prospective Pilot Study (prospective + pilot_study)
Selected AbstractsLaparoscopic debulking of bulky lymph nodes in women with cervical cancer: indication and surgical outcomesBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 5 2009R Tozzi Objective, To describe the technique and the surgical outcome of laparoscopic resection of bulky lymph nodes before adjuvant treatment. Design, Prospective pilot study. Setting, Gynaecological oncology cancer centre. Population, From January 2006 to February 2008, 22 consecutive women presented with cervical cancer and bulky metastatic lymph nodes (>2 cm). Methods, All women underwent resection of bulky lymph nodes by laparoscopy. A prospective record of the main surgical outcomes was performed. Main outcome measures, Safety and efficacy of laparoscopic resection of bulky lymph nodes, conversion to laparotomy, intra- and perioperative morbidity. Results, All the operations were completed by laparoscopy. Median operative time was 197 minutes (range 180,320). Median blood loss was 60 cc (range 10,100), two women experienced complications: one thermal injury of the sciatic root provoking postoperative leg palsy and one chylous ascites. The woman with the thermal injury has recovered most leg function with physiotherapy and the woman with chylous ascites recovered within 2 weeks, slightly delaying the adjuvant treatment. All women were discharged within 4 days from the operation (range 2,4). Pathology reports confirmed the presence of tumour metastases and the lymph nodes size. The adjuvant treatment started at a median time of 12 days (range 3,22). Conclusion, Debulking of large pelvic and para-aortic lymph nodes was effectively accomplished by laparoscopy in all 22 women with 9% complication rate. The surgical outcome is similar to historical series on women operated on by laparotomy, with the advantage of a faster recovery and an early start of adjuvant treatment. [source] Continuous Subcutaneous Glucose Monitoring System in diabetic mothers during labour and postnatal glucose adaptation of their infantsDIABETIC MEDICINE, Issue 4 2008E. Stenninger Abstract Aims To assess a new technique for continuous monitoring of glucose concentration during labour in diabetic mothers. A second objective was to study maternal glucose levels in relation to postnatal glucose adaptation and the need for intravenous (IV) glucose treatment in the newborn infant. Methods Fifteen pregnant women with insulin-treated diabetes mellitus participated in this prospective pilot study. To measure their glucose control during labour we used the Continuous Subcutaneous Glucose Monitoring System (CGMS; Medtronic, Minneapolis, MN, USA) to calculate the mean glucose concentration and the area under the curve (AUC) in the last 120 min before delivery. All infants of these women were transferred to the neonatal care unit for early oral feeding and blood glucose measurements up to 14 h after delivery. Infants received IV glucose if blood glucose values were repeatedly < 2.2 mmol/l. Results All women coped well with the CGMS monitoring. AUC 0,120 min before delivery, mean glucose concentration 0,120 min before delivery and cord plasma insulin level were all significantly associated with the need for IV glucose in the newborn children. Conclusions In this study we found an association between maternal glucose concentrations during labour and postnatal glucose adaptation and need for IV glucose treatment in the infants. Online monitoring of glucose levels during delivery might help us to achieve maternal normoglycaemia and further reduce the risk of postnatal hypoglycaemia in the offspring. [source] Impact of Body Mass Index on Markers of Left Ventricular Thickness and Mass Calculation: Results of a Pilot AnalysisECHOCARDIOGRAPHY, Issue 3 2005Ranjini Krishnan M.D. Specific correlations between body mass index (BMI) and left ventricular (LV) thickness have been conflicting. Accordingly, we investigated if a particular correlation exists between BMI and echocardiographic markers of ventricular function. Methods: A total of 122 patients, referred for routine transthoracic echocardiography, were included in this prospective pilot study using a 3:1 randomization approach. Patient demographics were obtained using a questionnaire. Results: Group I consisted of 80 obese (BMI was >30 kg/m2), Group II of 16 overweight (BMI between 26 and 29 kg/m2), and Group III of 26 normal BMI (BMI < 25 kg/m2) individuals. No difference was found in left ventricular wall thickness, LV end-systolic cavity dimension, fractional shortening (FS), or pulmonary artery systolic pressure (PASP) among the groups. However, mean LV end-diastolic cavity dimension was greater in Group I (5.0 ± 0.9 cm) than Group II (4.6 ± 0.8 cm) or Group III (4.4 ± 0.9 cm; P < 0.006). LV mass indexed to height2.7 was also significantly larger in Group I (61 ± 21) when compared to Group III (48 ± 19; P < 0.001). Finally, left atrial diameter (4.3 ± 0.7 cm) was also larger (3.8 ± 0.6 and 3.6 ± 0.7, respectively; P < 0.00001).Discussion: We found no correlation between BMI and LV wall thickness, FS, or PASP despite the high prevalence of diabetes and hypertension in obese individuals. However, obese individuals had an increased LV end-diastolic cavity dimension, LV mass/height2.7, and left atrial diameter. These findings could represent early markers in the sequence of cardiac events occurring with obesity. A larger prospective study is needed to further define the sequence of cardiac abnormalities occurring with increasing BMI. [source] Adrenal Insufficiency in Critically Ill Emergency Department Patients: A Taiwan Preliminary StudyACADEMIC EMERGENCY MEDICINE, Issue 7 2001Shy-Shin Chang MD Objective: Unrecognized adrenal insufficiency can have serious consequences in critically ill emergency department (ED) patients. This prospective pilot study of adrenal function in patients with severe illness was undertaken to determine the prevalence of adrenal dysfunction and any relation to prior herbal drug use. Methods: In a high-volume urban tertiary care ED, adult patients with sepsis or acute myocardial infarction (AMI) were eligible for the study. Over a two-month period, a convenience sample was enrolled by the authors on arrival to the ED. Inclusion criteria were systemic inflammatory response syndrome (SIRS) criteria plus evidence of at least one organ dysfunction or cardiac marker plus electrocardiogram-proven AMI. Exclusion criteria included known corticosteroid use. Serum cortisol was measured on arrival and for those patients with a level of <15 ,g/dL (<414 nmol/L), an adrenocorticotropic hormone (ACTH) stimulation test was performed. Results: Of the 30 enrolled patients, 23 (77%) were suffering from severe sepsis and the other seven (23%) had an AMI. Thirteen of the 30 patients (43%; 95% CI = 25% to 65%) had serum cortisol levels of <15 ,g/dL, consistent with adrenal insufficiency, nine with severe sepsis and four with an AMI. Eight (62%; 95% CI = 32% to 86%) of the 13 patients with low cortisol levels reported using herbal medications, while only two (12%; 95% CI = 1% to 36%) of the 17 with normal cortisol levels reported taking herb drugs (p = 0.01). Only two (15%; 95% CI = 2% to 45%) of the patients with low cortisol levels failed their corticotropin stimulation test, suggestive of true adrenocortical insufficiency. Both reported using herbal preparations. Conclusions: These results indicate that adrenal dysfunction is common among a group of critically ill patients seen in this Taiwanese ED. Moreover, the use of herbal drugs was high in the patients with low serum cortisols. Further studies are required to both confirm these findings and clarify whether a number of herbal medications contain corticosteroids. [source] Complement Activation in Emergency Department Patients With Severe SepsisACADEMIC EMERGENCY MEDICINE, Issue 4 2010John G. Younger Abstract Objectives:, This study assessed the extent and mechanism of complement activation in community-acquired sepsis at presentation to the emergency department (ED) and following 24 hours of quantitative resuscitation. Methods:, A prospective pilot study of patients with severe sepsis and healthy controls was conducted among individuals presenting to a tertiary care ED. Resuscitation, including antibiotics and therapies to normalize central venous and mean arterial pressure (MAP) and central venous oxygenation, was performed on all patients. Serum levels of Factor Bb (alternative pathway), C4d (classical and mannose-binding lectin [MBL] pathway), C3, C3a, and C5a were determined at presentation and 24 hours later among patients. Results:, Twenty patients and 10 healthy volunteer controls were enrolled. Compared to volunteers, all proteins measured were abnormally higher among septic patients (C4d 3.5-fold; Factor Bb 6.1-fold; C3 0.8-fold; C3a 11.6-fold; C5a 1.8-fold). Elevations in C5a were most strongly correlated with alternative pathway activation. Surprisingly, a slight but significant inverse relationship between illness severity (by sequential organ failure assessment [SOFA] score) and C5a levels at presentation was noted. Twenty-four hours of structured resuscitation did not, on average, affect any of the mediators studied. Conclusions:, Patients with community-acquired sepsis have extensive complement activation, particularly of the alternative pathway, at the time of presentation that was not significantly reversed by 24 hours of aggressive resuscitation. ACADEMIC EMERGENCY MEDICINE,2010; 17:353,359 © 2010 by the Society for Academic Emergency Medicine [source] Systemic and local cytokine production in quiescent ulcerative colitis and its relationship to future relapse: A prospective pilot studyINFLAMMATORY BOWEL DISEASES, Issue 6 2005Takayuki Yamamoto MD Abstract Background: The main aim of this prospective study was to examine whether systemic (plasma) and local (mucosal) cytokine production is a predictor of future relapse in patients with quiescent ulcerative colitis (UC). The impact of other clinical and laboratory parameters on relapse was also studied. Methods: Fifty consecutive patients with quiescent UC were included. At enrollment, blood and mucosal (rectal biopsies) samples were collected. All patients were followed up regularly for 1 year after enrollment. Plasma and mucosal cytokine levels were measured by enzyme-linked immunosorbent assay. To identify independent significant predictive factors for relapse, time-dependent analyses using the Kaplan-Meier method and the Cox proportional hazard model were performed. Results: Thirty-four patients remained in remission, and 16 patients relapsed during the 1-year follow-up. Higher interleukin (IL)-8 levels in the rectal mucosa were significantly associated with relapse. In contrast, IL-1,, IL-6, and tumor necrosis factor-, levels in the rectal mucosa were not associated with relapse. Conventional blood markers and plasma cytokines (IL-1,, IL-6, IL-8, and tumor necrosis factor-,) did not correlate with relapse. Among clinical factors, age and number of prior relapses were significantly associated with relapse. In multivariate analysis, a higher rectal mucosal IL-8 level (,160 pg/mg of tissue; hazard ratio, 4.7), younger age (<30 yr; hazard ratio, 7.3), and a greater number of prior relapses (,5; hazard ratio, 4.3) were independent significant risk factors for future relapse. Conclusions: Rectal mucosal IL-8 measurement might be an additional objective diagnostic tool that can predict relapse in patients with quiescent UC. [source] A prospective pilot study of antibodies against human papillomaviruses and cutaneous squamous cell carcinoma nested in the Oxford component of the European Prospective Investigation into Cancer and NutritionINTERNATIONAL JOURNAL OF CANCER, Issue 8 2007Delphine Casabonne Abstract In a prospective pilot study nested in the EPIC-Oxford cohort, we examined the seroprevalence of antibodies against the L1 antigen of 38 human papilloma virus (HPV) types among 39 cases of cutaneous squamous cell carcinoma (SCC) for whom plasma was collected prior to diagnosis (incident) and 80 controls. Fifteen cases having already developed SCC at blood collection (prevalent) were also tested. There were no statistically significant differences in the seroprevalence of antibodies against any of the HPV types examined between incident cases and controls, nor was there a difference in the seroprevalence of multiple infections. However, consistent with results from published case,control studies, the seroprevalence of many ,-HPV types was higher among prevalent cases than among either incident cases or controls. For example the seroprevalence of antibodies against HPV-8 was 20% (16/80) in controls, 23% (9/39) among incident cases and 40% (6/15) among prevalent cases. Among the incident cases only, the seroprevalence was 16% (5/32) among those for whom blood was collected 18+ months prior to diagnosis, but 57% (4/7) among those for whom diagnosis was within 18 months of blood collection, a pattern seen for many of the HPV types. This might suggest that if HPV is involved in the aetiology of SCC, the process occurs close to the time of diagnosis, or that the antibody response observed in people with SCC is a consequence of tumor formation. Further and larger prospective studies are needed to clarify the role of HPV in the aetiology of cutaneous SCC. © 2007 Wiley-Liss, Inc. [source] Prospective study of short-term peginterferon-,-2a monotherapy in patients who had a virological response at 2 weeks after initiation of interferon therapyJOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Issue 4 2008Soocheol Jeong Abstract Background and Aims:, Long-term interferon (IFN) therapy is effective in eliminating hepatitis C virus (HCV). However, it carries the risk of adverse effects and reduced quality of life. To assess whether short-term IFN therapy effectively eliminates HCV, we performed a prospective pilot study of pegylated (peg)IFN-,-2a therapy for 8 or 24 weeks. Methods:, After excluding patients with high titers of genotype-1, 55 HCV patients received pegIFN-,-2a. Patients who became negative for HCV-RNA at week 2 were allocated to either an 8-week (n = 19) or 24-week (n = 15) course of IFN. We evaluated the efficacy of and tolerance to IFN therapy. Results:, The sustained virological response rate was excellent in the two groups (8 weeks, 89.5% [17/19]; 24 weeks, 100% [15/15], respectively,). IFN dose reduction was required in one patient of the 8-week group, but in six patients of the 24-week group (P = 0.028). Treatment was completed by all patients of the 8-week group, but discontinued in five patients of the 24-week group (P = 0.011). Conclusions:, The 8-week IFN therapy is more tolerable than the 24-week therapy and had similar outcomes. Excluding the patients with high titers of genotype-1, we recommend switching to an 8-week course of pegIFN-, monotherapy once patients show an ultra rapid virological response at week 2 from the start of IFN therapy. [source] A prospective pilot study of a multidisciplinary home training programme for lateral epicondylitisMUSCULOSKELETAL CARE, Issue 1 2007Pia Nilsson PTR Abstract Objective:,To evaluate a new multidisciplinary structured home training programme for patients with lateral epicondylitis compared to conventional attendance. Design:,This study utilized a prospective non-randomized design to compare the effect of a home exercise programme against a pragmatic approach to managing patients with lateral epicondylitis in a primary care setting in Sweden. Subjects:,A total of 78 patients, presenting to their general practitioner with lateral epicondylitis were recruited from two separate geographical areas. The patients were divided into two group, 51 entered the intervention group and 27 entered the control group. Methods:,The intervention group was treated with a specific home training programme, ergonomic advice and when necessary wrist and/or night bandages. The control group was treated with conventional treatment, e.g. corticosteroid injections, stretching or no intervention. Pain and function were evaluated by the PRFEQ. An electronic hand-power gauge measured strength and stamina. Sick-leave absence was collected via the regional Social Insurance Office. Results:,After four weeks the intervention group experienced less sick-leave, less pain, better function and returned to work earlier than the control group. After 16 weeks the intervention group still had significantly better function than the control group and were taking less sick-leave. Pain decreased more in the intervention group but this was not significant. There was no difference in grip strength between the two groups. Conclusion:,A structured home training programme can improve function and reduce sick leave in patients with lateral epicondylitis. Copyright © 2006 John Wiley & Sons, Ltd. [source] Probiotic supplementation affects pulmonary exacerbations in patients with cystic fibrosis: A pilot studyPEDIATRIC PULMONOLOGY, Issue 6 2010Batia Weiss MD Abstract Objective Probiotics reduce intestinal inflammation in, and Lactobacillus GG (LGG) reduces pulmonary exacerbation rate cystic fibrosis (CF) patients. We intended to determine the effect of a mixed probiotic preparation on pulmonary exacerbations and inflammatory characteristics of the sputum in CF patients. Study Design A prospective pilot study of 10 CF patients with mild,moderate lung disease and Pseudomonas aeruginosa colonization, treated with probiotics for 6 months. Pulmonary function tests (PFT's), sputum cultures with semi-quantitative bacterial analysis, and sputum neutrophil count and interleukin-8 (IL-8) levels were compared to pre-treatment and post-treatment values. The rate of pulmonary exacerbations was compared to 2 years prior to the study. Results The exacerbation rate was significantly reduced in comparison to the previous 2 years and to 6 months post-treatment (P,=,0.002). PFT's have not changed at the end of treatment and during 6 months post-treatment. No change in sputum bacteria, neutrophil count, and IL-8 levels was observed. Conclusion Probiotics reduce pulmonary exacerbations rate in patients with CF. Probiotics may have a preventive potential for pulmonary deterioration in CF patients. Pediatr Pulmonol. 2010; 45:536,540. © 2010 Wiley-Liss, Inc. [source] Plasma ADMA concentrations at birth and mechanical ventilation in preterm infants: A prospective pilot studyPEDIATRIC PULMONOLOGY, Issue 12 2008Milan C. Richir MD Abstract Rationale Nitric oxide (NO) produced in the lung is an important mediator of normal lung development, vascular smooth muscle relaxation, and ventilation perfusion matching. NO is synthesized from arginine by the action of NO-synthase (NOS). Asymmetric dimethylarginine (ADMA), an endogenous derivate of arginine, inhibits NOS and is thereby a determinant of NO synthesis. We compared ADMA and arginine levels in preterm infants requiring mechanical ventilation with preterm infants who did not require mechanical ventilation and determined the relation between ADMA and the length of mechanical ventilation in these infants. Methods Thirty preterm infants, mean (SD) gestational age 29.3 (1.7) weeks and birth weight 1,340 (350) gram, of the Neonatal Intensive Care Unit of the VU University Medical Center were included. ADMA and arginine were measured in umbilical cord blood and the length of mechanical ventilation (days) was registered. Results Gestational age and birth weight were significantly smaller in infants requiring mechanical ventilation, but were not significantly correlated with plasma ADMA concentration after birth. Plasma ADMA concentrations were significantly higher in infants who required mechanical ventilation than in infants who did not require mechanical ventilation (1.53,±,0.23 and 1.37,±,0.14 µmol/L, respectively; P,=,0.036). ADMA concentration was significantly related to length of mechanical ventilation (B,=,3.4; 95% CI: 1.1,5.6; P,=,0.006), also after adjustment for gestational age (B,=,2.3; 95% CI: 0.4,4.2; P,=,0.024). Conclusions Preterm infants who require mechanical ventilation have increased ADMA levels compared to non-ventilated preterm infants. ADMA levels at birth are related to the length of mechanical ventilation. An increased ADMA concentration could reduce NO synthesis, which could lead to insufficient gas exchange and, consequently, a longer period of mechanical ventilation. Pediatr. Pulmonol. 2008; 43:1161,1166. © 2008 Wiley-Liss, Inc. [source] A multicenter, prospective pilot study of gamma knife radiosurgery for mesial temporal lobe epilepsy: Seizure response, adverse events, and verbal memory,ANNALS OF NEUROLOGY, Issue 2 2009Nicholas M. Barbaro MD Objective The safety, efficacy, and morbidity of radiosurgery (RS) must be established before it can be offered as an alternative to open surgery for unilateral mesial temporal lobe epilepsy. We report the 3-year outcomes of a multicenter, prospective pilot study of RS. Methods RS was randomized to 20 or 24Gy targeting the amygdala, hippocampus, and parahippocampal gyrus. Seizure diaries evaluated the final seizure remission between months 24 and 36. Verbal memory was evaluated at baseline and 24m with the Wechsler Memory Scale,Revised (WMS-R) and California Verbal Learning Test (CVLT). Patients were classified as having "significant improvement," "no change," and "significant impairment" based on relative change indices. Results Thirteen high-dose and 17 low-dose patients were treated. Both groups showed significant reductions in seizures by 1 year after treatment. At the 36-month follow-up evaluation, 67% of patients were free of seizures for the prior 12 months (high dose: 10/13, 76.9%; low dose: 10/17, 58.8%). Use of steroids, headaches, and visual field defects did not differ by dose or seizure remission. The prevalence of verbal memory impairment was 15% (4/26 patients); none declined on more than one measure. The prevalence of significant verbal memory improvements was 12% (3/26). Interpretation RS for unilateral mesial temporal lobe epilepsy offers seizure remission rates comparable with those reported previously for open surgery. There were no major safety concerns with high-dose RS compared with low-dose RS. Additional research is required to determine whether RS may be a treatment option for some patients with mesial temporal lobe epilepsy. Ann Neurol 2009 [source] Original Article: Predicting the outcome of induction of labourAUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 4 2010Ralph NADER Objective:, To test whether prediction of delivery outcome is feasible in post-term nulliparous pregnant women, using a published model and a locally produced model combining clinical and ultrasound assessment. Methods:, This is a prospective pilot study of 53 nulliparous women seen in a postdates clinic between 40 weeks four days and 41 weeks three days of gestation. They underwent a routine assessment including transabdominal ultrasound to determine amniotic fluid index, a Bishop score, and translabial ultrasound to determine the station of the fetal head at rest and bladder neck descent at rest and on valsalva. Additional information such as body weight at booking and current weight, height and a family history of caesarean section was obtained. Delivery outcome and labour details were obtained from the local obstetric database. Two models for prediction of delivery outcome were tested. Results:, Forty-nine complete datasets were analysed. Fourteen women had a normal vaginal delivery, 17 instrumental deliveries and 18 caesarean sections. A published model predicted the induction outcome in 62%. A local model using maternal age, body mass index, family history of caesarean section, station of the fetal head and bladder neck descent predicted vaginal delivery in 70% in our study. Conclusion:, Prediction of delivery outcome is of limited feasibility in post-term nulliparous pregnant women. Our locally produced model was successful in predicting vaginal delivery in 70% of women. Prediction of delivery outcome may not be sufficiently powerful to allow modification of current obstetric practice. [source] The use of levonorgestrel-releasing intrauterine system for treatment of menorrhagia in women with inherited bleeding disordersBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 12 2004C.E.C. Kingman Background The levonorgestrel-releasing intrauterine system (LNG-IUS) is used commonly by gynaecologists as a contraceptive and to treat menorrhagia. However, its efficacy has not been examined in women with inherited bleeding disorders. Design A prospective pilot study. Setting A teaching hospital in north London with a designated haemophilia centre. Population Female patients with a known inherited bleeding disorder. Methods Sixteen women with subjective and objective menorrhagia caused by inherited bleeding disorders (13 von Willebrand's Disease, two factor XI deficiency and one Hermansky,Pudlak syndrome), who had previously undergone unsuccessful medical treatment were followed up for nine months after LNG-IUS insertion. Bleeding was measured by pictorial chart and haemoglobin concentration. Main outcome measure Results All women reported that their periods were improved, pictorial chart scores were lower and 56% became amenorrhoeic. None reported side effects. Conclusion The LNG-IUS is well tolerated and effective and improves quality of life. [source] Real-time polymerase chain-reaction detection of pathogens is feasible to supplement the diagnostic sequence for urinary tract infectionsBJU INTERNATIONAL, Issue 1 2010Lutz E. Lehmann OBJECTIVE To evaluate, in a prospective pilot study, the feasibility of identifying pathogens in urine using real-time polymerase chain reaction (PCR), and to compare the results with the conventional urine culture-based procedures. PATIENTS AND METHODS Severe urinary tract infections (UTIs) are frequent in critically ill patients in the intensive-care unit (ICU) and in outpatients, and thus the reliable and fast identification of the bacteria is mandatory, but routine urine culture is time-consuming and the therapeutic regimen is often calculated and not culture-based. The study included 301 prospectively collected urine samples from 189 patients with suspected UTI, based in a university hospital in 2005, and included outpatients and those in the ICU. Urine culture with Cled-, MacConkey- and malt extract agar of all samples was followed by microbiological identification of the pathogens in 98 samples with visible growth. In parallel, all samples were assessed using qualitative real-time PCR-based DNA detection and identification by labelled hybridization probes. RESULTS In all, 15 dipstick culture-negative samples showed positive pathogen DNA identification by PCR. By contrast, 17 PCR-negative samples showed detectable pathogens by culture, of which 10 were not detectable on PCR because the identified pathogens were not represented in the probe panel. The sensitivity and specificity for detecting contaminated samples was 0.90 and 0.87, respectively. Overall, 95% of the mono-infection pathogens and 57% of the multiple-infection pathogens were detected concordantly with both methods. CONCLUSION In this prospective pilot study PCR-based identification of pathogens was feasible for supplementing conventional culture methods for the diagnosis of UTI. The main advantage is the time saved in identifying the pathogens. The limited pathogen detection in multiple-infection-samples by PCR might be explained by competitive PCR amplification conditions. [source] Pilot study of reduced-intensity conditioning followed by allogeneic stem cell transplantation from related and unrelated donors in patients with myelofibrosisBRITISH JOURNAL OF HAEMATOLOGY, Issue 5 2005Nicolaus Kröger Summary A prospective pilot study was performed to evaluate the effect of reduced-intensity conditioning with busulphan (10 mg/kg), fludarabine (180 mg/qm) and anti-thymocyte globulin followed by allogeneic stem cell transplantation from related (n = 8) and unrelated donors (n = 13) in 21 patients with myelofibrosis. The median age of the patients was 53 years (range, 32,63). No primary graft failure occurred. The median time until leucocyte (>1·0 × 109/l) and platelet (>20 × 109/l) engraftment was 16 (range, 11,26) and 23 d (range, 9,139) respectively. Complete donor chimaerism on day 100 was seen in 20 patients (95%). Acute graft- versus -host disease (GvHD) grades II,IV and III/IV occurred in 48% and 19% of cases and 55% of the patients had chronic GvHD. Treatment-related mortality was 0% at day 100 and 16% [95% confidence interval (CI): 0,32%] at 1 year. Haematological response was seen in 100% and complete histopathological remission was observed in 75% of the patients and 25% of the patients showed partial histopathological remission with a continuing decline in the grade of fibrosis. After a median follow-up of 22 months (range, 4,59), the 3-year estimated overall and disease-free survival was 84% (95% CI: 67,100%). [source] A prospective pilot study of curative-intent stereotactic body radiation therapy in patients with 5 or fewer oligometastatic lesions,CANCER, Issue 3 2008Michael T. Milano MD Abstract BACKGROUND. It is hypothesized that oligometastatic disease represents a state of potentially curable, limited metastases. Stereotactic body radiation therapy (SBRT) is an option for patients who are not amenable to or do not want resection. METHODS. From 2001 to 2006, 121 patients with ,5 detectable metastases were enrolled in 2 prospective studies that used curative-intent SBRT. Most patients were treated with 10 fractions of 5 Gray. Stereotactic radiosurgery was offered to patients with brain metastases. RESULTS. The 2-year overall survival (OS), progression-free survival (PFS), local control (LC), and distant control (DC) rates were 50%, 26%, 67%, and 34%, respectively; and the respective 4-year rates values were 28%, 20%, 60%, and 25%. A greater net tumor volume predicted significantly worse OS, PFS, LC, and DC. Patients with breast cancer fared significantly better with respect to OS, PFS, LC, and DC; and patients with adrenal metastases had significantly worse OS, PFS, and DC despite the small number of such patients enrolled. Neither the number of metastatic lesions nor the number of organs involved was a significant predictor of outcome. Among 45 patients who remained alive at the last follow-up, 29 patients had no evidence of disease, including 23 patients with ,2 years of follow-up. CONCLUSIONS. Oligometastatic disease is a potentially curable state of distant cancer spread. In this hypothesis-generating analysis, patients with less volume burden of their metastatic disease and those with primary breast cancer fared better. SBRT delivered with curative intent in patients with limited metastases should be investigated further. The Southwest Oncology Group is developing a prospective protocol to treat women who have limited breast cancer metastases with SBRT. Cancer 2008. © 2007 American Cancer Society. [source] Can older cancer patients tolerate chemotherapy?CANCER, Issue 4 2003A prospective pilot study Abstract BACKGROUND To the authors' knowledge, few data currently are available regarding the tolerance to chemotherapy in older cancer patients. This prospective pilot study evaluated the changes in functional, mental, nutritional, and comorbid status, as well as the quality of life (QOL), in geriatric oncology patients receiving chemotherapy. METHODS Sixty patients age , 70 years who were undergoing cancer chemotherapy were recruited in a university-based comprehensive cancer center. Changes in physical function were measured by the Eastern Cooperative Oncology Group performance status (ECOG PS) and Instrumental Activities of Daily Living (IADLs), mental health changes were measured by the Mini-Mental State Examination and the Geriatric Depression Scale (GDS), comorbidity was measured by Charlson's index and the Cumulative Illness Rating Scale-Geriatric, nutrition was measured by the Mini-Nutritional Assessment, and QOL was measured by the Functional Assessment of Cancer Therapy-General (FACT-G). Changes were assessed at baseline and at the end of treatment (EOT). Grade 4 hematologic and Grade 3,4 nonhematologic toxicities were recorded. RESULTS Thirty-seven patients (63%) completed both assessments. Older cancer patients demonstrated a significant decline in measurements of physical function after receiving chemotherapy, as indicated by changes in scores on the IADL (P = 0.04) and on the physical (P = 0.01) and functional (P = 0.03) subscales of the FACT-G. They also displayed worse scores on the GDS administered postchemotherapy (P < 0.01). Patients who experienced severe chemotoxicity had more significant declines in ECOG PS (P = 0.03), IADL (P = 0.03), and GDS (P = 0.04), and more gain in the social well-being subscale (P = 0.02) of the FACT-G, than those who did not experience severe chemotoxicity. However, changes in most scores were small in magnitude clinically. No significant change was found between baseline and EOT in nutrition, comorbidity, and other aspects of the FACT-G. CONCLUSIONS Older cancer patients undergoing chemotherapy may experience toxicity but generally can tolerate it with limited impact on independence, comorbidity, and QOL levels. It is important to recognize and monitor these changes during geriatric oncology treatment. Cancer 2003;97:1107,14. © 2003 American Cancer Society. DOI 10.1002/cncr.11110 [source] Repeated peribulbar injections of triamcinolone acetonide: a successful and safe treatment for moderate to severe Graves' ophthalmopathyACTA OPHTHALMOLOGICA, Issue 1 2009Marcela Bordaberry Abstract. Purpose:, In this study, we aimed to evaluate the efficacy of peribulbar triamcinolone injections to treat inflammatory signs of Graves' ophthalmopathy (GO) in patients with moderate to severe GO and associated optic neuropathy (ON). Methods:, Twenty-one patients with active GO [clinical activity score (CAS) , 4] and systemic thyroid disease under control were enrolled in this prospective pilot study. Peribulbar triamcinolone acetonide was injected in each orbit (42 eyes), in four doses of 20 mg at 2-week intervals. Ophthalmological examination including CAS evaluation, visual field, computerized tomography (CT) scan and digital photography were performed before and after treatment. Results:, Twenty-one patients (11 with moderate disease, 10 with ON) were enrolled in this study and followed for at least 14 months. Initial mean CAS was 6.38 ± 1.49, which dropped to 1.8 ± 1.12 after 6 months of treatment (P = 0.01; mean difference of 4.57 ± 1.56; range 1,8 score points). ON was diagnosed in 10 patients. Of these, 66% improved with peribulbar triamcinolone exclusively. A transitory increase in intraocular pressure in two patients was controlled with topic medication. Conclusion:, Peribulbar triamcinolone injections reduce the inflammatory signs of moderate GO, as measured by the CAS, and could also be used as an alternative treatment for ON. Randomized clinical trials are needed to compare the results of triamcinolone peribulbar injections to those of other treatment modalities. [source] Osteotome sinus floor elevation without grafting material: a 1-year prospective pilot study with ITI implantsCLINICAL ORAL IMPLANTS RESEARCH, Issue 6 2006Rabah Nedir Abstract Objective: The aim of the present pilot study was to evaluate: (1) the predictability of an osteotome sinus floor elevation procedure with ITI-SLA implants without placing a bone grafting material, and (2) the possibility to gain bone height without filling the created space with a bone grafting material. Material and methods: Seventeen patients received 25 implants protruding in the sinus. Most implants (21/25) were 10 mm long, eight were inserted in type 2 bone, 12 in type 3 and five in type 4 bone. At implant placement, the mean residual bone height (RBH) under the maxillary sinus was 5.4±2.3 mm; it was 5.7±2.6 mm on the mesial side and 5.1±1.9 mm on the distal side. Nineteen implants had less than 6 mm of bone on at least one side and six implants had less than 6 mm on both sides. A healing period of 3,4 months was allowed before abutment tightening at 35 Ncm. The percentage of stable implants at abutment tightening and at the 1-year control was calculated. The endo-sinus bone gain and the crestal bone loss (CBL) at the mesial and distal sides were measured. Results: Abutments were tightened after 3.1±0.4 months. All implants but one (96%) resisted the applied 35 Ncm torque. At the 1-year control, all implants were clinically stable and supported the definitive prosthesis. All showed endo-sinus bone gain; the mean gain was 2.5±1.2 mm. The mean CBL was 1.2±0.7 mm. Endo-sinus bone gain and RBH showed a strong negative correlation (r=,0.78 on the mesial side and ,0.80 on the distal side). A good correlation (r=0.73) was found between implant penetration in the sinus and endo-sinus bone gain. Conclusion: Elevation of the sinus membrane alone without addition of bone grafting material can lead to bone formation beyond the original limits of the sinus floor. Despite a limited RBH at implant placement, a healing period of 3 months was sufficient to resist a torque of 35 N cm and to lead to a predictable implant function at the 1-year control. [source] | |||||||||||||||||||||||||