Search results for "Random"
showing 10 items of 3931 documents
Randomized clinical trial to evaluate the effects of perioperative supplemental oxygen administration on the colorectal anastomosis
2006
Abstract Background Perioperative supplemental oxygen therapy may have beneficial effects on wound healing following colorectal surgery. The aim of this study was to evaluate the effects of such therapy on colorectal anastomotic pH and partial pressure of carbon dioxide (Pco2) gap. Methods Forty-five patients undergoing anterior resection for rectal or sigmoid cancer were randomized to receive 30 or 80 per cent perioperative oxygen. Administration was commenced after induction of anaesthesia and maintained for 6 h after surgery. Intragastric and anastomotic tonometric catheters were placed in each patient and intramucosal pH (pHi) was measured immediately after operation, and 6 and 24 h lat…
Inflammation after sclerocorneal versus clear corneal tunnel phacoemulsification.
2000
Abstract Objective To compare the postoperative inflammation after phacoemulsification followed by intraocular lens (IOL) implantation by means of sclerocorneal versus clear corneal tunnel incision. Design Randomized controlled clinical trial. Participants One hundred eyes of 100 patients were examined at a German University eye hospital. Intervention One hundred eyes with cataract necessitating phacoemulsification with posterior chamber IOL implantation were randomly assigned to receive a temporal sclerocorneal or clear corneal tunnel incision by a single surgeon. Main outcome measures Preoperative and postoperative inflammation was evaluated by measurement of flare using laser flare photo…
Symptom course in inpatient and day clinic treatment of depression: Results from the INDDEP-Study.
2015
Abstract Background In major depression (MDD), hospital treatment is an option in more severe cases or if outpatient treatment failed. Psychosomatic hospitals in Germany provide treatment programs with multimodal psychotherapy, either in an inpatient or a day hospital setting. In the context of health care research, this study aimed (1) to compare characteristics of patients treated in psychosomatic day hospitals and inpatient units, (2) to compare the effectiveness of both treatment modalities. Methods A naturalistic design was chosen to achieve external validity. 604 consecutive patients were assessed at admission, discharge and a 3-month follow-up. Primary outcome was defined as a reduct…
"Dry biopsies" with spraying of dilute epinephrine optimize biopsy mapping of long segment Barrett's esophagus
2008
BACKGROUND AND STUDY AIMS: For surveillance of Barrett’s esophagus random stepwise four-quadrant biopsy (4QB) is recommended for detecting macroscopically occult neoplasias. Thorough performance of the systematic protocol is commonly hampered by poor visibility due to oozing from biopsy sites. Topical application of dilute epinephrine may prevent bleeding by vasoconstriction of superficial microvessels and might therefore enable ”dry biopsy” sampling. The aim of this study was to examine the safety and efficacy of spraying dilute epinephrine for optimal 4QB mapping of Barrett’s esophagus. PATIENTS AND METHODS: In this prospective, double-blind trial 40 patients with known long segment Barre…
Long-term Effects of Multimodal Treatment on Adult Attention-Deficit/Hyperactivity Disorder Symptoms: Follow-up Analysis of the COMPAS Trial.
2019
Key Points Question What are the long-term results of multimodal treatment for adult attention-deficit/hyperactivity disorder (ADHD) when comparing cognitive behavioral group psychotherapy (GPT) with individual clinical management (CM) in combination with either methylphenidate or placebo? Findings In this follow-up assessment of the Comparison of Methylphenidate and Psychotherapy in Adult ADHD Study (COMPAS), a multicenter randomized clinical trial, 256 adults participated in follow-up 1.5 years after the intervention ended. The severity of ADHD symptoms improved in all 4 prior treatment groups, with no significant difference found between GPT and CM, but methylphenidate was associated wit…
Deterioration in quality of life (QOL) in patients with malignant ascites : Results from a phase II/III study comparing paracentesis plus catumaxomab…
2012
Background: Malignant ascites (MA) is associated with poor prognosis and limited palliative therapeutic options. Therefore, quality of life (QoL) assessment is of particular importance to demonstrate new treatment value. Following the demonstration of the superiority of catumaxomab and paracentesis over paracentesis on puncture-free survival, this analysis aimed at comparing deterioration in QoL between both the treatment options. Patients and methods: In a randomised, multicentre, phase II/III study of patients with MA due to epithelial cell adhesion molecule (EpCAM) positive cancer, the QoL was evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life …
Mycophenolate mofetil versus azathioprine in patients with chronic active ulcerative colitis: a 12-month pilot study.
2000
Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) of unknown etiology frequently requiring long-term therapy for control of symptoms and prevention of relapse. Azathioprine (AZA) has been shown to be effective and safe in the treatment of chronic active UC. However, the alternatives to treatment with AZA are limited. Our aim was to compare the efficacy and safety of treatment with mycophenolate mofetil (MMF)/prednisolone versus standard immunosuppressive treatment with azathioprine (AZA)/prednisolone in patients with chronic active UC.The study was designed as an open comparison of MMF versus AZA. Twenty-four patients with active UC (Rachmilewitz scoreor =6 points) were randoml…
Prognostic effect of carbohydrate antigen 125-guided therapy in patients recently discharged for acute heart failure (CHANCE-HF). Study design.
2014
Abstract Introduction and objectives Morbidity and mortality after admission for acute heart failure remain prohibitively high. In that setting, plasma levels of antigen carbohydrate 125 have shown to correlate with the severity of fluid overload and the risk of mortality and readmission. Preliminary data suggests a potential role of antigen carbohydrate 125 to guide therapy. The objective of this study is to evaluate the prognostic effect of an antigen carbohydrate 125-guided management strategy vs standard therapy in patients recently discharged for acute heart failure. Methods This is a multicenter, randomized, single-blind, efficacy trial study of patients recently discharged from acute…
OASIS-HT: design of a pharmacogenomic dose-finding study.
2005
Experimental evidence and observations in humans strongly support an interactive role of mutated α-adducin, sodium (Na+)/potassium (K+)-adenosine triphosphatase (ATPase) activity and endogenous ouabain in Na+homeostasis and the pathogenesis of hypertension. The Ouabain and Adducin for Specific Intervention on Sodium in HyperTension (OASIS-HT) trial is an early Phase II dose-finding study, which will be conducted across 39 European centers. Following a run-in period of 4 weeks without treatment, eligible patients will be randomized to one of five oral doses of rostafuroxin consisting of 0.05, 0.15, 0.5, 1.5, or 5.0 mg/day. Each dose will be compared to a placebo in a double-blind crossover e…
A new delivery system of clobetasol-17-propionate (lipid-loaded microspheres 0.025%) compared with a conventional formulation (lipophilic ointment in…
2004
Summary Background Topical application of clobetasol-17-propionate has been diffusely reported as an efficacious therapy in atrophic/erosive oral lichen planus (OLP), without exposing the patient to systemic side-effects. However, prolonged contact and respective topical effects on the oral mucosa should be avoided. Objectives The aim of the present study was to evaluate efficacy and compliance of new lipid microspheres loaded with 0·025% of clobetasol propionate (formulation A) compared with a commonly used formulation (a sort of dispersion of a lipophilic ointment in a hydrophilic phase) with the same amount of drug (formulation B) in the topical treatment of OLP. Patients and methods …