Search results for "OUTCOME"
showing 10 items of 5148 documents
Long-term sequential deferiprone-deferoxamine versus deferiprone alone for thalassemia major patients: a randomised clinical trial
2009
A multicentre randomized open-label trial was designed to assess the effectiveness of long-term sequential deferiprone–deferoxamine (DFO–DFP) versus DFP alone to treat thalassaemia major (TM). DFP at 75 mg/kg, divided into three oral daily doses, for 4 d/week and DFO by subcutaneous infusion (8–12 h) at 50 mg/kg per day for the remaining 3 d/week was compared with DFP alone at 75 mg/kg, administered 7 d/week during a 5-year follow-up. The main outcome measures were differences between multiple observations of serum ferritin concentrations. Secondary outcomes were survival analysis, adverse events, and costs. Consecutive thalassaemia patients (275) were assessed for eligibility; 213 of these…
Efficacy, safety and quality of life of calcipotriol/betamethasone dipropionate (Dovobet (R)) versus calcipotriol (Daivonex (R)) in the treatment of …
2007
Objective: A clinical trial was performed to evaluate the efficacy, speed of response, side effects and quality of life of patients treated with calcipotriol/betamethasone dipropionate (Dovobet (R)) for 4 weeks followed by maintenance with calcipotriol for 8 weeks (group A) versus calcipotriol (Daivonex (R)) alone for 12 weeks (group B) for the treatment of psoriasis. Materials and methods: A total of 150 patients were enrolled and randomized to groups A and B. PASI and Skindex-29 were considered the outcome measures. Results: Ninety-six patients completed the trial. At weeks 2 and 4, both groups showed a significant clinical improvement compared to baseline; group A demonstrated a higher c…
Randomized clinical trial of botulinum toxin injection for pain relief in patients with thrombosed external haemorrhoids
2008
Abstract Background Thrombosed external haemorrhoids are one of the most frequent anorectal emergencies. They are associated with swelling and intense pain. Internal sphincter hypertonicity plays a role in the aetiology of the pain. This study evaluated the efficacy and safety of an intrasphincteric injection of botulinum toxin for pain relief in patients with thrombosed external haemorrhoids. Methods Thirty patients with thrombosed external haemorrhoids who refused surgical operation were randomized into two groups. Patients received an intrasphincteric injection of either 0·6 ml saline or 0·6 ml of a solution containing 30 units botulinum toxin. Anorectal manometry was performed before tr…
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…
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…
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…
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 Comparison of Five Maintenance Therapies for Reflux Esophagitis
1995
Patients with reflux esophagitis have a high rate of relapse within one year after therapy is discontinued.We enrolled 175 adults with endoscopy-confirmed reflux esophagitis in a prospective study comparing five maintenance therapies. All the patients were initially treated with omeprazole (40 mg orally once a day) for four to eight weeks, and healing was confirmed by endoscopy. Participants were then stratified according to their initial grade of esophagitis and randomly assigned to 12 months of treatment with one of the following: cisapride (10 mg three times a day), ranitidine (150 mg three times a day), omeprazole (20 mg per day), ranitidine plus cisapride (10 mg three times a day), or …
Effect of dulaglutide on cognitive impairment in type 2 diabetes: an exploratory analysis of the REWIND trial
2020
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Clinical outcomes after implantation of a posterior chamber collagen copolymer phakic intraocular lens with a central hole for myopic correction.
2013
Purpose To evaluate the efficacy, predictability, safety, and stability of a new-model posterior chamber Implantable Collamer Lens phakic intraocular lens (pIOL) (V4c Visian) to correct myopia. Setting Private practice, Oviedo, Spain. Design Case series. Methods This study enrolled patients who had implantation of a new pIOL design with a central hole for more natural aqueous flow, eliminating the need for neodymium:YAG iridotomy or peripheral iridectomy. The uncorrected (UDVA) and corrected (CDVA) distance visual acuities, refractive error, intraocular pressure (IOP), endothelial cell count, central vault, and adverse events were evaluated 6 months postoperatively. Results The study enroll…