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Randomized Study (randomize + study)
Selected AbstractsThe Effect of Preemptive Analgesia in Postoperative Pain Relief,A Prospective Double-Blind Randomized StudyPAIN MEDICINE, Issue 1 2009Seetharaman Hariharan MD ABSTRACT Objective., To analyze the effect of infiltration of local anesthetics on postoperative pain relief. Design., Prospective randomized double-blind trial. Setting., University Teaching Hospital in Barbados, West Indies. Patients., Patients undergoing total abdominal hysterectomy. Interventions., Patients were randomly allocated into one of four groups according to the wound infiltration: 1) preoperative and postoperative 0.9% saline; 2) preoperative saline and postoperative local anesthetic mixture (10 mL 2% lidocaine added to 10 mL 0.5% bupivacaine); 3) preoperative local anesthetic mixture and postoperative saline; and 4) preoperative and postoperative local anesthetic mixture. Both patients and investigators were blinded to the group allocation. All patients received pre-incision tenoxicam and morphine, standardized anesthesia, and postoperative morphine by patient-controlled analgesia. Outcome measures., The amount of morphine used and the intensity of pain as measured by visual analog pain scale were recorded at 1, 2, 3, 4, 8, 12, 24, and 48 hours postoperatively. Results., Eighty patients were studied with 20 in each group. Total dose of morphine used by patients who received preoperative and postoperative local anesthetic infiltration was lesser compared to other groups, although there was no statistically significant difference. Similarly, there was no difference in the intensity of pain between any groups. Conclusions., Local anesthetic infiltration before and/or after abdominal hysterectomy does not reduce the intensity of postoperative pain and analgesic requirements. [source] The story of the European Randomized Study of Screening for Prostate CancerBJU INTERNATIONAL, Issue 2003F.H. Schröder First page of article [source] Contamination by opportunistic screening in the European Randomized Study of Prostate Cancer ScreeningBJU INTERNATIONAL, Issue 2003S. Ciatto First page of article [source] Efficacy of imatinib dose escalation in patients with chronic myeloid leukemia in chronic phase,,§CANCER, Issue 3 2009Hagop M. Kantarjian MD Abstract BACKGROUND: Imatinib mesylate given orally at a daily dose of 400 mg is the standard of care as initial therapy for patients with chronic myeloid leukemia (CML) in chronic phase (CML-CP). Treatment guidelines propose dose escalation based on clinical assessments of disease response. METHODS: Response and survival were analyzed in a cohort of patients (n = 106) with newly diagnosed CML-CP who were enrolled on the International Randomized Study of Interferon and STI571 (IRIS) trial, who began treatment with imatinib at a dose of 400 mg daily, and who subsequently underwent dose escalation to either 600 mg or 800 mg daily. Reasons for dose escalation were evaluated retrospectively based on 2 sets of criteria: the IRIS protocol-defined criteria (n = 39 patients) and the European LeukemiaNet (ELN) recommendations (n = 48 patients). RESULTS: Among all 106 patients who underwent dose escalation, the rates of freedom from progression to accelerated phase or blast phase and overall survival were 89% and 84% at 3 years after dose increase, respectively. A cytogenetic response was obtained in 42% of patients who had their dose escalated based on protocol criteria and in 38% of patients who had their dose escalated according to the ELN recommendations. CONCLUSIONS: The results from this retrospective analysis supported imatinib dose escalation as an appropriate initial option for patients with CML-CP who were experiencing suboptimal cytogenetic response or resistance. Cancer 2009. © 2008 American Cancer Society. [source] Efficacy and Safety of Tadalafil 20 mg on Demand vs.THE JOURNAL OF SEXUAL MEDICINE, Issue 8 2010Tadalafil 5 mg Once-a-Day in the Treatment of Post-Radiotherapy Erectile Dysfunction in Prostate Cancer Men: A Randomized Phase II Trial ABSTRACT Introduction., The role of phosphodiesterase type 5 inhibitors in the treatment of post-radiotherapy erectile dysfunction (ED) has not been extensively investigated. Aim., To compare the efficacy and safety of on-demand 20-mg tadalafil (arm A) with the newly released tadalafil 5-mg once-a-day dosing (arm B) in patients with ED following radiotherapy for prostate cancer (PC). Methods., Randomized study to receive on-demand 20-mg or once-a-day 5-mg tadalafil for 12 weeks. Main Outcome Measures., Changes in the International Index of Erectile Function (IIEF) domain scores and Sexual Encounter Profile (SEP) question 2 and 3 positive response rates. Results., Fifty-two out of 86 screened patients were randomized. Forty-four patients were evaluable for efficacy. A significant improvement in all domains of the IIEF was observed in both arms (P = 0.0001) with mean erectile function domain scores values of 25 and 27.1 for the 20-mg and 5-mg tadalafil, respectively (P = 0.19). SEP 2 and 3 positive response rates increased from 0% in both arms at baseline to 81% and 70% in the 20-mg arm and 90% and 73% in the 5-mg arm, respectively, at the end of treatment (P = 0.27). End of treatment global efficacy question positive answers were 86% in the 20-mg arm and 95% in the 5-mg arm (P = 0.27). Higher treatment compliance was shown in arm B (100%) as compared with arm A (86%). There was a nonstatistically significant trend toward fewer side effects in favor of the 5-mg daily dose arm. Conclusions., In the study population, both tadalafil formulations generated significantly high response rates according to the outcome measures and were well tolerated. The once-a-day 5-mg dosing showed higher compliance and marginally reduced side effects, thus making it an attractive alternative to on-demand therapy for ED in post-radiotherapy PC patients. Ricardi U, Gontero P, Ciammella P, Badellino S, Valentino F, Munoz F, Guarneri A, Rondi N, Moretto F, Filippi AR, Ragona R, and Tizzani A. Efficacy and safety of tadalafil 20 mg on demand vs. tadalafil 5 mg once-a-day in the treatment of post-radiotherapy erectile dysfunction in prostate cancer men: A randomized phase II trial. J Sex Med 2010;7:2851,2859. [source] Features and preliminary results of the Dutch centre of the ERSPC (Rotterdam, the Netherlands)BJU INTERNATIONAL, Issue 2003M.J. Roobol OBJECTIVE To describe the preliminary results of the Dutch section of a large multicentre study of screening for prostate cancer, the European Randomized study of Screening for Prostate Cancer (ERSPC), initiated in the Netherlands and Belgium in 1991. MATERIALS AND METHODS After a series of five pilot studies which started in 1991, full-capacity screening started in 1994 with the use of a serum prostate-specific antigen (PSA) determination, a digital rectal examination (DRE) and transrectal ultrasonography (TRUS) as screening tests. Depending on the results and the screening protocol used, men were referred for further examination by sextant biopsies (extended with a seventh biopsy if TRUS showed abnormality). The protocols used, efficiency of the different screening tests, number of cancers detected in the pilot studies, initial screening round and preliminary results of the second screening round are described. RESULTS After the pilot studies it became clear that a study of prostate cancer screening was feasible in the Rotterdam area. The screening protocol was workable and the recruitment rate acceptable (39.5%). An inventory of the population registries of Rotterdam and surrounding municipalities, and the known recruitment rate, made it clear that a contribution of 40 000 men (aged 55,74 years) from the Dutch centre to the ERSPC was feasible. The initial screening round started in December 1993 and lasted until December 1999 (protocol 5,10). In all, 42 376 men were randomized and 1014 cancers detected (5.1%). During this screening the protocol was simplified. After evaluating the different screening tests abnormal results of the DRE and TRUS were omitted as an indication for a sextant biopsy. Only a serum PSA level of , 3.0 ng/mL is now used as the indication. The second screening round started in December 1997 and continues. To December 2002, 9920 men were screened for the second time, 4 years after their initial screening visit. To date 446 cancers have been detected (4.5%); this round will last to December 2003. Further evaluation of the screening regimen and characteristics of the cancers detected are constantly assessed within the Dutch ERSPC. Meanwhile a third screening round has also been initiated, which will last to December 2007. CONCLUSION A prostate cancer screening study of the projected magnitude is feasible in Rotterdam; the recruitment rate is acceptable and the screening tests well tolerated. The study has generated many scientific publications and will be of great value in determining whether prostate cancer screening should be part of general healthcare. [source] | ||||||||||