Search results for "randomized"
showing 10 items of 2323 documents
Impact of fluoroscopy on oral double-balloon enteroscopy: results of a randomized trial in 156 patients
2010
Background and study aims The routine utility of fluoroscopy during double-balloon enteroscopy (DBE) via the oral route has been not prospectively evaluated. Up to now, there have been no prospective randomized trials to assess whether fluoroscopy improves outcomes. The aim of this study was to assess the value of fluoroscopy during oral DBE. Patients and methods A total of 156 patients (88 men, 56.4 %) of mean (standard deviation [SD]) age 56 (19) years were randomly assigned to undergo oral DBE either with or without fluoroscopy. The majority of the patients had obscure gastrointestinal bleeding (n = 96, 62 %). The primary target criteria for the study were postpyloric insertion depth and…
Efficacy and effectiveness of individual family intervention on social and clinical functioning and family burden in severe schizophrenia: a 2-year r…
2009
BackgroundEmpirical evidence of the efficacy and effectiveness of psychosocial family intervention and of the specificity of its effects on the course of schizophrenia is limited. The aim was to study the efficacy and effectiveness of psychosocial family intervention with regard to clinical and social functioning and family burden after controlling for compliance and several prognostic factors.MethodA 2-year randomized controlled trial with blind assessments. Fifty patients with DSM-IV schizophrenia and persistent positive symptoms and/or previous clinical relapse were allocated to psychosocial family intervention, individual counselling and standard treatment versus individual counselling …
A prospective, double-blind, placebo-controlled trial to establish a safe gluten threshold for patients with celiac disease
2007
BACKGROUND: Treatment of celiac disease (CD) is based on the avoidance of gluten-containing food. However, it is not known whether trace amounts of gluten are harmful to treated patients. OBJECTIVE: The objective was to establish the safety threshold of prolonged exposure to trace amounts of gluten (ie, contaminating gluten). DESIGN: This was a multicenter, double-blind, placebo-controlled, randomized trial in 49 adults with biopsy-proven CD who were being treated with a gluten-free diet (GFD) for > or =2 y. The background daily gluten intake was maintained at < 5 mg. After a baseline evaluation (t0), patients were assigned to ingest daily for 90 d a capsule containing 0, 10, or 50 mg glute…
Randomised study comparing 48 and 96 weeks peginterferon α-2a therapy in genotype D HBeAg-negative chronic hepatitis B
2013
Treatment with peginterferon α-2a (PegIFN) for 48 weeks is the standard of care for selected HBeAg-negative patients chronically infected with hepatitis B virus (HBV), but with limited treatment efficacy. A study was undertaken to investigate whether treatment extension to 96 weeks improves the outcome in this patient population.128 HBeAg-negative patients (120 genotype D) were randomised to weekly 180 μg PegIFN for 48 weeks (group A, n=51), 180 μg PegIFN for 48 weeks followed by 135 μg weekly for an additional 48 weeks (group B, n=52) or 180 μg PegIFN plus lamivudine (100 mg/day) for 48 weeks then 135 μg PegIFN for 48 weeks (group C, n=25). Endpoints were alanine aminotransferase normalisa…
Subtyping panic disorder by major depression and avoidance behaviour and the response to active treatment
1991
In order to establish the clinical validity of currently used ways of subtyping panic disorder the predictive power of associated current avoidance behaviour and (secondary) major depression for the response to active treatment (alprazolam, imipramine) was tested. The analysis was based on the data from the Cross-National-Collaborative-Panic-Study. Limited support for validity evidenced by predicting drug response was found for grading panic disorder by the severity of avoidance behaviour; patients with panic attacks and agoraphobia are more responsive to imipramine (compared with alprazolam) when using the reduction of the total number of panic attacks (or of spontaneous panic attacks) as …
The efficacy of acupuncture in human pain models: A randomized, controlled, double-blinded study
2012
Acupuncture is frequently used to treat pain, although data supporting the analgesic efficacy from placebo-controlled studies is sparse. In order to get evidence for acupuncture analgesia we performed a study with 2 well-recognized experimental human pain models - the cold-pressor (CP) test and intradermal capsaicin injection. Fifty healthy men were included. Our study compared Traditional Chinese Medicine-based acupuncture to sham acupuncture with Streitberger placebo needles in a randomized, controlled, double-blinded trial. The primary endpoint was the reduction of mean pain intensity during 3minutes of CP test or of mean pain intensity within 10minutes after capsaicin injection. Seconda…
Randomized trial of intravenous immunoglobulins versus prednisolone in Graves' ophthalmopathy.
1996
Abstract Glucocorticoids are usually given for management of Graves' ophthalmopathy (GO), but they may cause side effects. By comparison, intravenous administration of immunoglobulins resulted in clinical improvement and decreased antibody titres in a large number of autoimmune diseases. Therefore, a randomized trial was done, in which 19 patients with active GO were treated with a 20-week course of oral prednisolone (P, starting dose 100 mg/day), and 21 received 1 g immunoglobulin/kg body weight for 2 consecutive days every 3 weeks. The immunoglobulin course was repeated six times. Before and at the end (20 weeks) of immunomodulating therapy, ophthalmological investigation and quantitative…
Comparison of peri-implant bone loss between conventional drilling with irrigation versus low-speed drilling without irrigation
2016
Background To compare the technique of high speed drilling with irrigation and low speed drilling without irrigation in order to evaluate the success rate and peri-implant bone loss at 12 months of follow-up. Material and Methods A randomized, controlled, parallel-group clinical trial was carried out in patients requiring dental implants to rehabilitate their unitary edentulism. Patients were recruited from the Oral Surgery Unit of the University of Valencia (Spain) between September 2014 and August 2015. Patients who met the inclusion criteria were randomized to two groups: group A (high-speed drilling with irrigation) and group B (low-speed drilling without irrigation). The success rate a…
Ketorolac, diclofenac, and ketoprofen are equally safe for pain relief after major surgery
2002
Background Ketorolac is approved for the relief of postoperative pain but concerns have been raised over a possible risk of serious adverse effects and death. Two regulatory reviews in Europe on the safety of ketorolac found the data were inconclusive and lacked comparison with other non-steroidal anti-inflammatory drugs. The aim of this study was to compare the risk of serious adverse effects with ketorolac vs diclofenac or ketoprofen in adult patients after elective major surgery. Methods This prospective, randomized multicentre trial evaluated the risks of death, increased surgical site bleeding, gastrointestinal bleeding, acute renal failure, and allergic reactions, with ketorolac vs di…
Endocrine response after cervical manipulation and mobilization in people with chronic mechanical neck pain: a randomized controlled trial
2019
BACKGROUND: Most of the research on the effects of spinal manipulation on endocrine function has been done on healthy subjects and has yielded contradictory results. The potential role of cervical manual therapy intervention in order to induce changes in the endocrine system has not yet been investigated. AIM: The aim of this trial is to compare the effects on salivary cortisol levels and clinical outcomes of cervical manipulation versus cervical mobilization or sham manipulation in patients with chronic mechanical neck pain. DESIGN: Randomized controlled trial. SETTING: University of Alcala de Henares: outpatient (referrals from office workers). POPULATION: A total of 83 patients with chro…