Search results for "randomization"
showing 10 items of 148 documents
Efficacy of 3 toothbrush treatments on plaque removal in orthodontic patients assessed with digital plaque imaging: a randomized controlled trial.
2013
Good oral hygiene is a challenge for orthodontic patients because food readily becomes trapped around the brackets and under the archwires, and appliances are an obstruction to mechanical brushing. The purpose of this study was to compare plaque removal efficacy of 3 toothbrush treatments in orthodontic subjects.This was a replicate-use, single-brushing, 3-treatment, examiner-blind, randomized, 6-period crossover study with washout periods of approximately 24 hours between visits. Forty-six adolescent and young adult patients with fixed orthodontics from a university clinic in Germany were randomized, based on computer-generated randomization, to 1 of 3 treatments: (1) oscillating-rotating …
Effect of Lanadelumab Compared With Placebo on Prevention of Hereditary Angioedema Attacks: A Randomized Clinical Trial.
2018
Current treatments for long-term prophylaxis in hereditary angioedema have limitations.To assess the efficacy of lanadelumab, a fully human monoclonal antibody that selectively inhibits active plasma kallikrein, in preventing hereditary angioedema attacks.Phase 3, randomized, double-blind, parallel-group, placebo-controlled trial conducted at 41 sites in Canada, Europe, Jordan, and the United States. Patients were randomized between March 3, 2016, and September 9, 2016; last day of follow-up was April 13, 2017. Randomization was 2:1 lanadelumab to placebo; patients assigned to lanadelumab were further randomized 1:1:1 to 1 of the 3 dose regimens. Patients 12 years or older with hereditary a…
Knee arthroscopy and exercise versus exercise only for chronic patellofemoral pain syndrome: a randomized controlled trial.
2007
Abstract Background Arthroscopy is often used to treat patients with chronic patellofemoral pain syndrome (PFPS). As there is a lack of evidence, we conducted a randomized controlled trial to study the efficacy of arthroscopy in patients with chronic PFPS. Methods A total of 56 patients with chronic PFPS were randomized into two treatment groups: an arthroscopy group (N = 28), treated with knee arthroscopy and an 8-week home exercise program, and a control group (N = 28), treated with the 8-week home exercise program only. The arthroscopy included finding-specific surgical procedures according to current recommendations. The primary outcome was the Kujala score on patellofemoral pain and fu…
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…
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…