Adipose-Derived Regenerative Cell Transplantation for the Treatment of Hand Dysfunction in Systemic Sclerosis: A Randomized Clinical Trial.

Objective: Hand dysfunction is common in systemic sclerosis (SSc). We undertook this study to evaluate the capacity of autologous adipose-derived regenerative cells (ADRCs) to improve hand function in SSc patients.

Methods: The Scleroderma Treatment with Celution Processed Adipose Derived Regenerative Cells Trial was a prospective, randomized, double-blind trial of ADRCs, in which ADRCs were obtained from patients with SSc by small-volume adipose tissue harvest, and the fingers of each patient were injected with ADRCs.

Safety and Efficacy of Intravenous Golimumab in Adults with Ankylosing Spondylitis: Results through 1 Year of the GO-ALIVE Study.

Objective: Evaluate safety and efficacy of intravenous (IV) golimumab (GOL) in patients with active ankylosing spondylitis (AS) through 1 year.

Methods: A total of 208 patients were randomized to IV infusions of GOL 2 mg/kg (n = 105) at weeks 0, 4, and every 8 weeks thereafter or placebo (n = 103) at weeks 0, 4, and 12, then crossover to GOL at weeks 16, 20, and every 8 weeks thereafter through Week 52. Efficacy was assessed using the Assessment of Spondyloarthritis international Society (ASAS) criteria, the Ankylosing Spondylitis Disease Activity Score (ASDAS), the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Bath Ankylosing Spondylitis Functional Index (BASFI).

Applying global standards to short-term global health clinical experiences: the case of Project Salud y Paz.

This case study was extracted from an administrative report generated for Project Salud y Paz (SYP), a non-governmental organization (NGO) that supports short term global health clinical experiences (STGHCE) in Guatemala. As a basis to generate criticisms and offer recommendations, the analysis used the shared themes of two sets of standards recently published by Globalization and Health (GH) and the American College of Physicians (ACP). These standards respectively address the ethical responsibilities of organizations and of physicians in the conduct of STGHCE.

Guidelines for responsible short-term global health activities: developing common principles.

Background: Growing concerns about the value and effectiveness of short-term volunteer trips intending to improve health in underserved Global South communities has driven the development of guidelines by multiple organizations and individuals. These are intended to mitigate potential harms and maximize benefits associated with such efforts.

Method: This paper analyzes 27 guidelines derived from a scoping review of the literature available in early 2017, describing their authorship, intended audiences, the aspects of short term medical missions (STMMs) they address, and their attention to guideline implementation.

Why do they care? Narratives of physician volunteers on motivations for participation in short-term medical missions abroad.

Background: Short-term medical missions (STMMs) refer to the provision of direct pro bono medical services in lower and middle income countries for periods ranging from days to a few weeks by physicians from rich countries. Survey data have provided limited information on demographic and professional profiles of physicians as well as monetary and manpower inputs. Understanding why physicians participate, however, remains incomplete.

Demographic profile of physician participants in short-term medical missions.

Background: The US is the leading sending country for short term medical missions (STMMs), an unregulated and unsanctioned, grass roots form of direct medical service aid from richer countries to low and middle income countries. The objective of this study is to profile US physicians who go on such missions by means of a survey sample of the US physician population.

Methods: An online survey solicited information on physician participation in STMMS as well as demographic and professional features.

Economic assessment of US physician participation in short-term medical missions.

Background: Short term medical missions (STMMs) are a form of unregulated and unsanctioned, grass roots, direct medical service aid from wealthier countries to low and middle income countries. The US leads the world in STMM activity. The magnitude of monetary and man power inputs towards STMMs is not clear.

A systematic review of social, economic and diplomatic aspects of short-term medical missions.

Background: Short-term medical missions (STMMs) represent a grass-roots form of aid, transferring medical services rather than funds or equipment. The objective of this paper is to review empirical studies on social, economic and diplomatic aspects of STMMs.

Methods: A systematic literature review was conducted by searching PubMed and EBSCOhost for articles published from 1947-2014 about medical missions to lower and middle income countries (LMICs).

Why (not) go east? Comparison of findings from FDA Investigational New Drug study site inspections performed in Central and Eastern Europe with results from the USA, Western Europe, and other parts of the world.

Since the mid-1990s, investigational sites in the countries of Central and Eastern Europe (CEE) have been increasingly utilized by pharmaceutical companies because of their high productivity in terms of patient enrolment into clinical trials. Based on the FDA's publicly accessible Clinical Investigator Inspection List, we present an analysis of findings and outcome classifications from FDA inspections during Investigational New Drug (IND) studies and compare the results for the CEE region to those from Western European countries and the USA. Data from all 5531 FDA clinical trials inspections that occurred between 1994 (when the FDA first performed inspections in CEE) and the end of 2010 were entered into the database for comparative analysis.

Improved differential diagnosis of anemia of chronic disease and iron deficiency anemia: a prospective multicenter evaluation of soluble transferrin receptor and the sTfR/log ferritin index.

Anemia of chronic disease (ACD) and iron deficiency anemia (IDA) are the most prevalent forms of anemia and often occur concurrently. Standard tests of iron status used in differential diagnosis are affected by inflammation, hindering clinical interpretation. In contrast, soluble transferrin receptor (sTfR) indicates iron deficiency and is unaffected by inflammation.

Efficacy and safety of flavocoxid, a novel therapeutic, compared with naproxen: a randomized multicenter controlled trial in subjects with osteoarthritis of the knee.

Introduction: Flavocoxid is a novel flavonoid-based "dual inhibitor" of the 5-lipoxygenase (5-LOX) enzyme and the cyclooxygenase (COX) enzymes. This study was designed to compare the effectiveness and safety of flavocoxid to naproxen in subjects with moderate to severe osteoarthritis (OA) of the knee.

Methods: In this randomized, multicenter, double-blind study, 220 subjects were assigned to receive either flavocoxid (500 mg twice daily) or naproxen (500 mg twice daily) for 12 weeks.

A longterm endoscopic evaluation of patients with arthritis treated with nabumetone vs naproxen.

Objective: To compare the gastrointestinal safety, ulcerogenic potential, and clinical efficacy over 5 years of nabumetone and naproxen therapy, in patients with rheumatoid arthritis (RA) or osteoarthritis (OA).

Methods: Fifty-two patients entered a randomized, double blind study. Patients were randomized to 3 months treatment with either nabumetone, 1000 mg nightly, or naproxen, 250 mg twice daily, followed by an endoscopist-blind 5-year followup study.

Dance-based aerobic exercise for rheumatoid arthritis.

Reported here are the results of the first effort to examine the effects of a dance-based aerobic exercise program for people with rheumatoid arthritis (RA). Forty-three subjects with RA completed a 16-week program that met twice weekly for 2 hours. One hour was devoted to exercise consisting of 15 to 20 minutes of warm-ups, 20 to 30 minutes of dance-based aerobic exercise, and 15 to 20 minutes of mat work for muscle strengthening and flexibility.

Reduced risk of NSAID gastropathy (GI mucosal toxicity) with nonacetylated salicylate (salsalate): an endoscopic study.

This randomized, investigator-blinded, parallel group endoscopic study evaluated the effects of salsalate and naproxen on the gastroduodenal mucosa over a 3-month period in patients with RA. Using therapeutic doses of the drugs, 8 of 21 patients (38%) in the naproxen group had endoscopically shown active ulcers (seven patients) or diffuse erosions (one patient), whereas none of the 18 patients treated with salsalate (0%) had such lesions (P = .003).

Enteric-coated aspirin bezoar: elevation of serum salicylate level by barium study. Case report and review of medical management.

The gastric accumulation of enteric-coated aspirin tablets due to peptic ulcer disease or gastric outlet scarring and the impaired gastric emptying that results have been previously reported. In the case reported herein, an unanticipated peaking of plasma salicylate levels occurred following radiographic studies in which barium was used. This phenomenon prompted an in vitro study in which dissolution rates of enteric-coated aspirin in various barium preparations were determined, suggesting that dissolution is dependent upon effervescent activity of the milieu, as well as pH.