Search results for "Random"
showing 10 items of 3931 documents
Do asthmatic smokers benefit as much as non-smokers on budesonide/formoterol maintenance and reliever therapy? Results of an open label study
2012
SummaryBackgroundStudies with inhaled corticosteroids (ICS) in smoking asthmatics have mostly shown poorer treatment responses than in non-smoking asthmatics.MethodsEuroSMART, an open, randomised, 6-month study, compared budesonide/formoterol (Symbicort ® Turbuhaler®)hhNeither the Symbicort SMART posology nor the dry powder formulation, Turbuhaler, is currently approved in the US. maintenance and reliever therapy (Symbicort SMART®) at two maintenance doses of budesonide/formoterol (160/4.5 μg), 1 × 2 and 2 × 2, in patients with asthma who were symptomatic despite treatment with ICS ± long-acting β2-agonists. The 8424 randomised patients included 886 smokers (11%; aged <40 years or with a sm…
Ondasetron versus granisetron in the prevention of chemotherapy‐induced nausea and vomiting. Results of a prospective randomized trial
1994
Background. A single‐institution, prospective, randomized open trial was performed to compare ondansetron and granisetron in the prevention of chemotherapyrelated nausea and vomiting. The effect of antemetic drugs was analyzed indipendently for patients treated with highly emetogenic chemotherapy (Study 1), and those treated with moderately emetogenic regimens (Study 2). Methods. In Study 1. 182 patients treated with chemotherapeutic regimens containing high dose cisplatin (more than 70 mg/m2) were randomized to receive 24 mg of ondasentron intravenously (i. v.) or 3 mg of granisetron i. v. for the control of acute emesis. Patients treated with fractionated chemotherapy and those followed‐u…
Randomized Multicenter Phase II Trial of Two Different Schedules of Irinotecan Combined with Capecitabine as First-Line Treatment in Metastatic Color…
2004
BACKGROUND The aim of the current randomized Phase II study was to investigate the efficacy and safety of capecitabine combined with irinotecan as first-line treatment in metastatic colorectal carcinoma (CRC). METHODS A total of 140 patients received capecitabine at a dose of 1250 mg/m2 twice daily on Days 2–15 and irinotecan at a dose of either 300 mg/m2 on Day 1 (Arm A) or 150 mg/m2 on Days 1 and 8 (Arm B) every 3 weeks. During the course of the study, enrollment was continued using lower doses of capecitabine (1000 mg/m2 twice daily) and irinotecan (Arm A: 240 mg/m2; Arm B: 120 mg/m2) to improve the safety profile of the combinations. RESULTS Efficacy was evaluable in 134 patients (68 in…
Modulation of 5-fluorouracil as adjuvant systemic chemotherapy in colorectal cancer: the IGCS-COL multicentre, randomised, phase III study
2005
The aims of this multicentre, randomised phase III trial were to evaluate: (1) the role of levamisol (LEV); and (2) the role of folinic acid (FA), added to 5-fluorouracil (5FU) in the adjuvant treatment of colorectal cancer. Patients with histologically proven, radically resected stage II or III colon or rectal cancer were eligible. The study had a 2x2 factorial design with four treatment arms: (a) 5FU alone, (b) 5FU+LEV, (c) 5FU+FA, (d) 5FU+LEV+FA, and two planned comparisons, testing the role of LEV and of FA, respectively. From March 1991, to September 1998, 1327 patients were randomised. None of the two comparisons resulted in a significant disease-free (DFS) or overall (OAS) survival a…
Phase III Randomized Trial of FOLFIRI Versus FOLFOX4 in the Treatment of Advanced Colorectal Cancer: A Multicenter Study of the Gruppo Oncologico Del…
2005
Purpose We performed this phase III study to compare the irinotecan, leucovorin (LV), and fluorouracil (FU) regimen (FOLFIRI) versus the oxaliplatin, LV, and FU regimen (FOLFOX4) in previously untreated patients with advanced colorectal cancer. Patients and Methods A total of 360 chemotherapy-naive patients were randomly assigned to receive, every 2 weeks, either arm A (FOLFIRI: irinotecan 180 mg/m2 on day 1 with LV 100 mg/m2 administered as a 2-hour infusion before FU 400 mg/m2 administered as an intravenous bolus injection, and FU 600 mg/m2 as a 22-hour infusion immediately after FU bolus injection on days 1 and 2 [LV5FU2]) or arm B (FOLFOX4: oxaliplatin 85 mg/m2 on day 1 with LV5FU2 regi…
Neo-adjuvant chemo-(immuno-)therapy of advanced squamous-cell head and neck carcinoma: a multicenter, phase III, randomized study comparing cisplatin…
1998
We carried out an open, randomized, phase III, multicenter clinical trial to compare, in neo-adjuvant setting, the clinical response and toxicity of the combination chemotherapy cisplatin + 5-FU with the same combination plus s.c. recombinant interleukin-2 (rIL-2) in patients with advanced (stage III IV) head and neck squamous-cell carcinoma (HNSCC). Regimen A was the classical Al Sarraf treatment: 100 mg/m2 cisplatin i.v. on day 1 plus 1000 mg m(-2) day(-1) 5-FU on days 1-5 as a continuous infusion. Regimen B was the same as regimen A plus 4.5 MIU/day rIL-2 s.c. on days 8-12 and 15-19. Treatment was repeated every 3 weeks for three cycles. A total of 33 patients were enrolled in the study;…
Pain Neurophysiology Education and Therapeutic Exercise for Patients With Chronic Low Back Pain: A Single-Blind Randomized Controlled Trial.
2018
Abstract: Objective To assess the effect of a pain neurophysiology education (PNE) program plus therapeutic exercise (TE) for patients with chronic low back pain (CLBP). Design Single-blind randomized controlled trial. Setting Private clinic and university. Participants Patients with CLBP for ≥6 months (N=56). Interventions Participants were randomized to receive either a TE program consisting of motor control, stretching, and aerobic exercises (n=28) or the same TE program in addition to a PNE program (n=28), conducted in two 30- to 50-minute sessions in groups of 4 to 6 participants. Main Outcomes Measures The primary outcome was pain intensity rated on the numerical pain rating scale whi…
Encoding, storage, and response preparation-Distinct EEG correlates of stimulus and action representations in working memory.
2019
Working memory (WM) allows for the active storage of stimulus- and higher level representations, such as action plans. This electroencephalography (EEG) study investigated the specific electrophysiological correlates dissociating action-related from stimulus-related representations in WM using three different experimental conditions based on the same stimulus material. In the experiment, a random sequence of single numbers (from 1 to 6) was presented and participants had to indicate whether the current number (N0 condition), the preceding number (N-1 condition), or the sum of the current and the preceding number (S-1 condition) was odd or even. Accordingly, participants had to store a stimu…
Early viral clearance and sustained response in chronic hepatitis C: a controlled trial of interferon and ribavirin after high-dose interferon induct…
2002
High-dose induction with alpha-interferon induces early viral clearance of hepatitis C and combined with ribavirin enhances sustained response. We assess whether adding ribavirin after viral clearance obtained by alpha-interferon induction increased the rate of viral eradication.Forty-one naïve patients with chronic hepatitis C were randomised to receive, after 4 weeks of 10 mU daily of alpha-interferon (induction), 3 mU daily for 22 weeks and 3 mU thrice weekly for 26 weeks of either interferon alone (monotherapy) or interferon plus 1000-1200 mg daily of ribavirin (combination therapy). At the end of the induction phase, 23 (56%) subjects had cleared HCV-RNA. During therapy, breakthrough w…
Osteopathic manual therapy versus conventional conservative therapy in the treatment of temporomandibular disorders: A randomized controlled trial
2010
Summary Objective Temporomandibular disorders (TMD) is a term reflecting chronic, painful, craniofacial conditions usually of unclear etiology with impaired jaw function. The effect of osteopathic manual therapy (OMT) in patients with TMD is largely unknown, and its use in such patients is controversial. Nevertheless, empiric evidence suggests that OMT might be effective in alleviating symptoms. A randomized controlled clinical trial of efficacy was performed to test this hypothesis. Methods We performed a randomized, controlled trial that involved adult patients who had TMD. Patients were randomly divided into two groups: an OMT group (25 patients, 12 males and 13 females, age 40.6±11.03) …