Repeatability of Quantitative Autofluorescence Imaging in a Multicenter Study Involving Patients With Recessive Stargardt Disease 1.

Purpose: This study assesses the repeatability of quantitative autofluorescence (qAF) in a multicenter setting and evaluates qAF as the end point for clinical trials in recessive Stargardt disease 1 (STGD1).

Methods: A total of 102 patients with STGD1 underwent qAF imaging as part of the Stargardt Remofuscin Treatment Trial (STARTT; EudraCT No. 2018-001496-20).

Evaluating the alginate oligosaccharide (OligoG) as a therapy for Burkholderia cepacia complex cystic fibrosis lung infection.

OligoG has previously shown potentiation of aztreonam against Burkholderia cepacia complex (Bcc) through biofilm disruption. A randomized, double-blind, placebo-controlled cross-over design was used to evaluate safety and efficacy of inhaled OligoG as a therapy for Bcc-infected CF patients taking aztreonam. Subjects received OligoG (1050 mg daily) or matching placebo for 28-days.

Inhaled dry powder alginate oligosaccharide in cystic fibrosis: a randomised, double-blind, placebo-controlled, crossover phase 2b study.

Background: OligoG is a low molecular-weight alginate oligosaccharide that improves the viscoelastic properties of cystic fibrosis (CF) mucus and disrupts biofilms, thereby potentiating the activity of antimicrobial agents. The efficacy of inhaled OligoG was evaluated in adult patients with CF.

Methods: A randomised, double-blind, placebo-controlled multicentre crossover study was used to demonstrate safety and efficacy of inhaled dry powder OligoG.

A Randomized, Double-blind, Placebo-controlled Clinical Study to Investigate the efficacy of Herring Roe Oil for treatment of Psoriasis.

The effect of omega-3 polyunsaturated fatty acid supplements in patients with psoriasis vulgaris has previously been investigated, but interventions varied in source, composition, dose, administration route and duration of treatment. The observed beneficial effects in patients with psoriasis vulgaris using herring roe oil as a dietary supplement prompted this investigation. This randomised, double-blind and placebo-controlled study was designed and performed to explore the efficacy and safety of herring roe oil supplementation in 64 patients with plaque psoriasis (ClinicalTrials.

Adherence to subcutaneous interferon beta-1a treatment using an electronic injection device: a prospective open-label Scandinavian noninterventional study (the ScanSmart study).

Background: Disease modifying drugs help control the course of relapsing remitting multiple sclerosis (RRMS); however, good adherence is needed for long-term outcomes.

Objective: To evaluate patient adherence to treatment with subcutaneous interferon beta-1a using RebiSmart and assess injection-site reactions and treatment satisfaction.

Methods: This prospective, single-arm, open-label, noninterventional multicenter Phase IV trial included disease modifying drug-experienced mobile patients with RRMS.

Safety, Tolerability, and Antihypertensive Effect of SER100, an Opiate Receptor-Like 1 (ORL-1) Partial Agonist, in Patients With Isolated Systolic Hypertension.

The purpose of the present trial was to evaluate safety, tolerability, and effect on systolic blood pressure (SBP) of SER100 in a small group of patients with isolated systolic hypertension (ISH) in treatment with at least 1 antihypertensive drug. Eligible patients were randomized to either SER100 (10 mg) or placebo in a crossover design, and 2 doses were given subcutaneously (SC), 8 hours apart, on 2 consecutive days. On all treatment days patients were monitored with an ambulatory blood pressure measurement device for 12 daytime hours.

Probiotic With or Without Fiber Controls Body Fat Mass, Associated With Serum Zonulin, in Overweight and Obese Adults-Randomized Controlled Trial.

Background: The gut microbiota is interlinked with obesity, but direct evidence of effects of its modulation on body fat mass is still scarce. We investigated the possible effects of Bifidobacterium animalisssp. lactis 420 (B420) and the dietary fiber Litesse® Ultra polydextrose (LU) on body fat mass and other obesity-related parameters.

Comparing Effects of Biologic Agents in Treating Patients with Rheumatoid Arthritis: A Multiple Treatment Comparison Regression Analysis.

Rheumatoid arthritis patients have been treated with disease modifying anti-rheumatic drugs (DMARDs) and the newer biologic drugs. We sought to compare and rank the biologics with respect to efficacy. We performed a literature search identifying 54 publications encompassing 9 biologics.

An approach to combining parallel and cross-over trials with and without run-in periods using individual patient data.

Background: In active run-in trials, where patients may be excluded after a run-in period based on their response to the treatment, it is implicitly assumed that patients have individual treatment effects. If individual patient data are available, active run-in trials can be modelled using patient-specific random effects. With more than one trial on the same medication available, one can obtain a more precise overall treatment effect estimate.

The effect of a corticosteroid cream and a barrier-strengthening moisturizer in hand eczema. A double-blind, randomized, prospective, parallel group clinical trial.

Background: Hand eczema is a common and persistent disease with a relapsing course. Clinical data suggest that once daily treatment with corticosteroids is just as effective as twice daily treatment.

Objectives: The aim of this study was to compare once and twice daily applications of a strong corticosteroid cream in addition to maintenance therapy with a moisturizer in patients with a recent relapse of hand eczema.

Treatment with a barrier-strengthening moisturizer prevents relapse of hand-eczema. An open, randomized, prospective, parallel group study.

Hand eczema influences the quality of life. Management strategies include the use of moisturizers. In the present study the time to relapse of eczema during treatment with a barrier-strengthening moisturizer (5% urea) was compared with no treatment (no medical or non-medicated preparations) in 53 randomized patients with successfully treated hand eczema.

Dispositional optimism and self-assessed situation awareness in a Norwegian military training exercise.

The current study examined the relationship between dispositional optimism and situation awareness. A sample of 77 Royal Norwegian Naval Academy and 57 Royal Norwegian Army Academy cadets were administered the Life Orientation Test prior to participating in a field-training exercise involving a series of challenging missions. Following an infantry mission component of the exercise, situation awareness was measured using the Mission Awareness Rating Scale (MARS), a self-assessment tool.

Functional free latissimus dorsi muscle flap to the proximal lower extremity.

Surgical treatment of lower extremity sarcoma often requires complete resection of muscle compartments resulting in disabling functional loss. Free muscle transfer has been used to restore function of the face and upper extremities, but few reports exist describing functional restoration of a lower extremity. A case report of a 21-year-old man requiring complete resection of the quadriceps musculature with successful functional reconstruction using a free latissimus dorsi muscle flap is described.

Topical 5-fluorouracil as primary therapy for keratoacanthoma.

Keratoacanthoma is a common, benign cutaneous neoplasm that displays rapid growth on sun-exposed skin. Keratoacanthomas usually involute spontaneously after several months but rarely progress to squamous cell carcinoma. Because this is a benign, self-limited lesion of exposed skin, effective treatment should emphasize patient comfort and cosmetic results in addition to effectiveness.

Collagenous fibroma (desmoplastic fibroblastoma).

Collagenous fibroma (desmoplastic fibroblastoma) is a recently described tumor that may arise in the subcutaneous tissue or skeletal muscle. We report a case of collagenous fibroma, occurring on the forehead of a 67-year-old man. An awareness of this entity is necessary to avoid confusion with other soft tissue neoplasms, especially extraabdominal fibromatosis.

NC100100, a new echo contrast agent for the assessment of myocardial perfusion--safety and comparison with technetium-99m sestamibi single-photon emission computed tomography in a randomized multicenter study.

Background And Hypothesis: Myocardial contrast echocardiography using second-generation agents has been proposed to study myocardial perfusion. A placebo-controlled, multicenter trial was conducted to evaluate the safety, optimal dose, and imaging mode for NC100100, a novel intravenous second-generation echo contrast agent, and to compare this technique with technetium-99m sestamibi (MIBI) single-photon emission computed tomography (SPECT).

Methods: In a placebo-controlled, multicenter trial, 203 patients with myocardial infarction > 5 days and < 1 year previously underwent rest SPECT and MCE.

Upper extremity salvage using the tensor fascia lata flap: report of two cases.

The tensor fascia lata pedicled flap was successfully used to salvage 3 severely injured upper extremities in 2 patients. Both patients had undergone 3 prior free tissue transfers without complete closure of their wounds. All 3 tensor fascia lata flaps (2 myocutaneous, 1 myofascial) survived entirely.

Accuracy and feasibility of contrast echocardiography for detection of perfusion defects in routine practice: comparison with wall motion and technetium-99m sestamibi single-photon emission computed tomography. The Nycomed NC100100 Investigators.

Objectives: We sought to assess the feasibility and accuracy of myocardial contrast echocardiography (MCE) using standard imaging approaches for the detection of perfusion defects in patients who had a myocardial infarction (MI).

Background: Myocardial contrast echocardiography may be more versatile than perfusion scintigraphy for identifying the presence and extent of perfusion defects after MI. However, its reliability in routine practice is unclear.

Lag-screw technique in free osseous mandibular reconstruction.

The surgical registry was reviewed for mandibular reconstruction from 1988 to 1992. During this time, 51 patients underwent mandibular reconstruction. Of this group, 17 patients had their microvascular bone grafts secured with lag-screw fixation.

An algorithm for maxillectomy defect reconstruction.

A maxillectomy defect creates a communication from oral cavity to nasal cavity that may extend to the orbit. Functional deglutition and speech problems with a significant soft tissue deficit ensue. This paper defines the reconstruction options for the spectrum of inferior partial maxillectomy defects to midface-orbital exonerations.

Angiosarcomas of the head and neck: clinical and pathologic characteristics.

Between 1974 and 1992, 32 patients with pathologically diagnosed angiosarcoma of the head and neck were evaluated at our institution. The primary treatment group consisted of 24 patients who had the initial diagnosis made or confirmed at our institution, and the other 8 patients formed the salvage group. There were 23 men and 9 women.

Tissue expansion in the upper extremities.

In this article, the authors demonstrate current concepts of soft-tissue reconstruction using tissue expansion principles. History, pathophysiology, and biomechanics of tissue expansion are reviewed. Anatomic areas of expander use in the upper extremity have been delineated, as well as new concepts of nerve and arterial elongation using intraoperative expansion techniques.