Mönchengladbach, Germany
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Nieves J.P.,Florida Atlantic University | Baum S.J.,Florida Atlantic University | Baum S.J.,Bethesda Hospital | Baum S.J.,Excel Medical Clinical Trials LLC
Cardiovascular Endocrinology | Year: 2017

The use of complementary and alternative medicine approaches has increased in the recent years. It has been utilized in both the treatment and prevention of many chronic diseases, especially in the management of hypertension, diabetes, and hyperlipidemia. Lifestyle modifications play a fundamental role in alternative and complementary medicine. Regular exercise, maintenance of optimal weight, and a healthful diet play vital roles in maintaining ideal health. Specifically, the Dietary Approaches to Stop Hypertension and Mediterranean diets have been established as having beneficial effects on blood pressure and cholesterol and even cardiovascular outcomes. Still, additional supplements including fish oil, CoQ10, and red yeast rice (among others) have shown promising beneficial effects. Unfortunately, many of the beneficial claims of natural products are not scientifically proven, lack reproducibility, and/or yield conflicting results. Until more concrete evidence can be produced, it is important for physicians and patients alike to familiarize themselves with these natural products and increase their awareness of any potential adverse effects. © 2017 Wolters Kluwer Health, Inc. All rights reserved.

Simkens L.H.J.,University of Amsterdam | Van Tinteren H.,Netherlands Cancer Institute | May A.,University Utrecht | Ten Tije A.J.,Amphia Hospital | And 20 more authors.
The Lancet | Year: 2015

Background The optimum duration of first-line treatment with chemotherapy in combination with bevacizumab in patients with metastatic colorectal cancer is unknown. The CAIRO3 study was designed to determine the efficacy of maintenance treatment with capecitabine plus bevacizumab versus observation. Methods In this open-label, phase 3, randomised controlled trial, we recruited patients in 64 hospitals in the Netherlands. We included patients older than 18 years with previously untreated metastatic colorectal cancer, with stable disease or better after induction treatment with six 3-weekly cycles of capecitabine, oxaliplatin, and bevacizumab (CAPOX-B), WHO performance status of 0 or 1, and adequate bone marrow, liver, and renal function. Patients were randomly assigned (1:1) to either maintenance treatment with capecitabine and bevacizumab (maintenance group) or observation (observation group). Randomisation was done centrally by minimisation, with stratification according to previous adjuvant chemotherapy, response to induction treatment, WHO performance status, serum lactate dehydrogenase concentration, and treatment centre. Both patients and investigators were aware of treatment assignment. We assessed disease status every 9 weeks. On first progression (defined as PFS1), patients in both groups were to receive the induction regimen of CAPOX-B until second progression (PFS2), which was the study's primary endpoint. All endpoints were calculated from the time of randomisation. Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00442637. Findings Between May 30, 2007, and Oct 15, 2012, we randomly assigned 558 patients to either the maintenance group (n=279) or the observation group (n=279). Median follow-up was 48 months (IQR 36-57). The primary endpoint of median PFS2 was significantly improved in patients on maintenance treatment, and was 8·5 months in the observation group and 11·7 months in the maintenance group (HR 0·67, 95% CI 0·56-0·81, p<0·0001). This difference remained significant when any treatment after PFS1 was considered. Maintenance treatment was well tolerated, although the incidence of hand-foot syndrome was increased (64 [23%] patients with hand-foot skin reaction during maintenance). The global quality of life did not deteriorate during maintenance treatment and was clinically not different between treatment groups. Interpretation Maintenance treatment with capecitabine plus bevacizumab after six cycles of CAPOX-B in patients with metastatic colorectal cancer is effective and does not compromise quality of life. Funding Dutch Colorectal Cancer Group (DCCG). The DCCG received financial support for the study from the Commissie Klinische Studies (CKS) of the Dutch Cancer Foundation (KWF), Roche, and Sanofi-Aventis. © 2015 Elsevier Ltd.

Stewart L.M.,University of Western Australia | Holman C.D.J.,University of Western Australia | Finn J.C.,University of Western Australia | Finn J.C.,Monash University | And 3 more authors.
Gynecologic Oncology | Year: 2013

Objectives: To compare the risk of borderline ovarian tumours in women having in vitro fertilization (IVF) with women diagnosed with infertility but not having IVF. Methods: This was a whole-population cohort study of women aged 20-44 years seeking hospital infertility treatment or investigation in Western Australia in 1982-2002. Using Cox regression, we examined the effects of IVF treatment and potential confounders on the rate of borderline ovarian tumours. Potential confounders included parity, age, calendar year, socio-economic status, infertility diagnoses including pelvic inflammatory disorders and endometriosis and surgical procedures including hysterectomy and tubal ligation. Results: Women undergoing IVF had an increased rate of borderline ovarian tumours with a hazard ratio (HR) of 2.46 (95% confidence interval [CI] 1.20-5.04). Unlike invasive epithelial ovarian cancer, neither birth (HR 0.89; 95% CI 0.43-1.88) nor hysterectomy (1.02; 0.24-4.37) nor sterilization (1.48; 0.63-3.48) appeared protective and the rate was not increased in women with a diagnosis of endometriosis (HR 0.31; 95% CI 0.04-2.29). Conclusions: Women undergoing IVF treatment are at increased risk of being diagnosed with borderline ovarian tumours. Risk factors for borderline ovarian tumours appear different from those for invasive ovarian cancer. © 2013 Elsevier Inc. All rights reserved.

Stewart L.M.,University of Western Australia | Holman C.D.J.,University of Western Australia | Aboagye-Sarfo P.,University of Western Australia | Finn J.C.,University of Western Australia | And 4 more authors.
Gynecologic Oncology | Year: 2013

Objectives: To examine the risk of invasive epithelial ovarian cancer in a cohort of women seeking treatment for infertility. Methods: Using whole-population linked hospital and registry data, we conducted a cohort study of 21,646 women commencing hospital investigation and treatment for infertility in Western Australia in the years 1982-2002. We examined the effects of IVF treatment, endometriosis and parity on risk of ovarian cancer and explored potential confounding by tubal ligation, hysterectomy and unilateral oophorectomy/salpingo-oophorectomy (USO). Results: Parous women undergoing IVF had no observable increase in the rate of ovarian cancer (hazard ratio [HR] 1.01; 95% confidence interval [CI] 0.35-2.90); the HR in women who had IVF and remained nulliparous was 1.76 (95% CI 0.74-4.16). Women diagnosed with endometriosis who remained nulliparous had a three-fold increase in the rate of ovarian cancer (HR 3.11; 95% CI 1.13-8.57); the HR in parous women was 1.52 (95% CI 0.34-6.75). In separate analyses, women who had a USO without hysterectomy had a four-fold increase in the rate of ovarian cancer (HR 4.23; 95% CI 1.30-13.77). Hysterectomy with or without USO appeared protective. Conclusions: There is no evidence of an increased risk of ovarian cancer following IVF in women who give birth. There is some uncertainty regarding the effect of IVF in women who remain nulliparous. Parous women diagnosed with endometriosis may have a slightly increased risk of ovarian cancer; nulliparous women have a marked increase in risk. © 2012 Elsevier Inc. All rights reserved.

Brulhart L.,Rheumatology HUG | Ziswiler H.-R.,OsteoRheuma Bern | Tamborrini G.,Bethesda Hospital | Zufferey P.,RH DAL
Clinical and Experimental Rheumatology | Year: 2015

Objective: Regarding recent progress, musculoskeletal ultrasound (US) will probably soon be integrated in standard care of patient with rheumatoid arthritis (RA). However, in daily care, quality of US machines and level of experience of sonographers are varied. We conducted a study to assess reproducibility and feasibility of an US scoring for RA, including US devices of different quality and rheumatologist with various levels of expertise in US as it would be in daily care. Methods: The Swiss Sonography in Arthritis and Rheumatism (SONAR) group has developed a semi-quantitative score using OMERACT criteria for synovitis and erosion in RA. The score was taught to 108 rheumatologists trained in US. One year after the last workshop, 19 rheumatologists participated in the study. Scans were performed on 6 US machines ranging from low to high quality, each with a different patient. Weighted kappa was calculated for each pair of readers. Results: Overall, the agreement was fair to moderate. Quality of device, experience of the sonographers and practice of the score before the study improved substantially the agreement. Agreement assessed on higher quality machine, among sonographers with good experience in US increased to substantial (median kappa for B-mode and Doppler: 0.64 and 0.41 for erosion). Conclusions This study demonstrated feasibility and reproducibility of the Swiss US SONAR score for RA. Our results confirmed importance of the quality of US machine and the training of sonographers for the implementation of US scoring in the routine daily care of RA. © Clinical and Experimental Rheumatology 2015.

Reid M.J.,Chelsea and Westminster Hospital | Booth G.,Bethesda Hospital | Khan R.J.K.,University of Western Australia | Janes G.,Perth Orthopaedics and Sports Medicine
Journal of Bone and Joint Surgery - Series A | Year: 2014

Background: Proponents of minimally invasive total knee arthroplasty argue that retracting rather than everting the patella results in quicker postoperative recovery and improved function. We aimed to investigate this in patients undergoing knee arthroplasty through a standard medial parapatellar approach. Methods: In a prospective randomized double-blinded study, sixty-eight patients undergoing total knee arthroplasty through a standard medial parapatellar approach were assigned to either retraction or eversion of the patella. Postoperatively, at three months, and at one year after surgery, an independent observer assessed the primary outcome measure (i.e., knee flexion) and secondary outcome measures (i.e., Oxford knee score, Short Form-12 [SF-12] score, visual analog scale pain score, knee motion, and alignment and patellar height as measured on radiographs with use of the Insall-Salvati ratio). Results: Early (three-month) follow-up showed no significant difference between patellar eversion and subluxation in flexion (mean and 95% confidence interval [CI], 101° ± 5.37° versus 102° ± 4.14°, respectively), Oxford knee scores (25 ± 3 versus 27 ± 2.69, respectively), SF-12, or visual analog scale pain scores (1.9 ± 0.54 versus 1.1 ± 0.44, respectively). A significant improvement in extension was found (23.9° ± 1.12° versus 22.0° ± 0.91°, respectively [p = 0.034]), but this was not clinically significant. There was no significant difference in any of the outcomes at one year. There was a significant difference in implant malpositioning between the eversion group and the subluxation group, with an increased percentage of lateral tibial overhang in the subluxation group (0.45 ± 0.39 versus 1.84 ± 0.82, respectively [p = 0.005]), but this did not correlate with functional outcome. There was no significant difference in alignment between the two groups (178.29° ± 0.84° versus 178.18° ± 0.78°). At one year after surgery, there was no difference between the two groups in Insall-Salvati ratio (1.15 ± 0.06 versus 1.12 ± 0.06) although there was a correlation between the percentage reduction in the ratio and functional outcome. There were two partial divisions of the patella tendon in the subluxation group, but no patella-related complications in the eversion group. Conclusions: The results of this trial showed that retracting rather than everting the patella during total knee arthroplasty resulted in no significant clinical benefit in the early to medium term. We observed no increase in patellar tendon shortening as a result of eversion rather than subluxation. Our findings did suggest that, with subluxation, there may be an increased risk of damage to the patellar tendon and reduced visualization of the lateral compartment, leading to an increase in implant malpositioning with lateral tibial overhang. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. Copyright © 2014 by the journal of bone and joint surgery, incorporated.

Keane M.,University of Minnesota | Deyo S.,University of Minnesota | Abosch A.,University of Minnesota | Bajwa J.A.,Bethesda Hospital | And 2 more authors.
Journal of Neural Engineering | Year: 2012

Deep brain stimulation (DBS) in the ventral intermediate nucleus of thalamus (Vim) is known to exert a therapeutic effect on postural and kinetic tremor in patients with essential tremor (ET). For DBS leads implanted near the caudal border of Vim, however, there is an increased likelihood that one will also induce paresthesia side-effects by stimulating neurons within the sensory pathway of the ventral caudal (Vc) nucleus of thalamus. The aim of this computational study was to (1) investigate the neuronal pathways modulated by therapeutic, sub-therapeutic and paresthesia-inducing DBS settings in three patients with ET and (2) determine how much better an outcome could have been achieved had these patients been implanted with a DBS lead containing directionally segmented electrodes (dDBS). Multi-compartment neuron models of the thalamocortical, cerebellothalamic and medial lemniscal pathways were first simulated in the context of patient-specific anatomies, lead placements and programming parameters from three ET patients who had been implanted with Medtronic 3389 DBS leads. The models showed that in these patients, complete suppression of tremor was associated most closely with activating an average of 62% of the cerebellothalamic afferent input into Vim (n = 10), while persistent paresthesias were associated with activating 35% of the medial lemniscal tract input into Vc thalamus (n = 12). The dDBS lead design demonstrated superior targeting of the cerebello-thalamo-cortical pathway, especially in cases of misaligned DBS leads. Given the close proximity of Vim to Vc thalamus, the models suggest that dDBS will enable clinicians to more effectively sculpt current through and around thalamus in order to achieve a more consistent therapeutic effect without inducing side-effects. © 2012 IOP Publishing Ltd.

Hart R.,University of Western Australia | Hart R.,Bethesda Hospital | Doherty D.A.,University of Western Australia | Doherty D.A.,King Edward Memorial Hospital
Journal of Clinical Endocrinology and Metabolism | Year: 2015

Context: The polycystic ovary syndrome (PCOS) is the commonest endocrine abnormality in women of reproductive age. Objective: To determine the rate of hospital admissions for women with PCOS in Western Australian population in comparison to women without PCOS. Design: A population-based retrospective cohort study using data linkage in a statewide hospital morbidity database system. Setting: All hospitals within Western Australia. Participants: A total of 2566 women with PCOS hospitalized from 1997-2011 and 25 660 randomly selected age-matched women without a PCOS diagnosis derived from the electoral roll. Main Outcome Measures: Hospitalizations by ICD-10-M diagnoses from 15 years were compared. Results: Hospitalizations were followed until a median age of 35.8 years (interquartile range, 31.0-39.9). PCOS was associated with more nonobstetric and non-injury-related hospital admissions (median, 5 vs 2; P < .001), a diagnosis of adult-onset diabetes (12.5 vs 3.8%), obesity (16.0 vs 3.7%), hypertensive disorder (3.8 vs 0.7%), ischemic heart disease (0.8 vs 0.2%), cerebrovascular disease (0.6 vs 0.2%), arterial and venous disease (0.5 vs 0.2% and 10.4 vs 5.6%, respectively), asthma (10.6 vs 4.5%), stress/anxiety (14.0 vs 5.9%), depression (9.8 vs 4.3%), licit/illicit drug-related admissions (8.8 vs 4.5%), self-harm (7.2 vs 2.9%), land transport accidents (5.2 vs 3.8%), and mortality (0.7 vs 0.4%) (all P < .001). Women with PCOS had a higher rate of admissions for menorrhagia (14.1 vs 3.6%), treatment of infertility (40.9 vs 4.6%), and miscarriage (11.1 vs 6.1%) and were more likely to require in vitro fertilization (17.2 vs 2.0%). Conclusion: PCOS has profound medical implications for the health of women, and health care resources should be directed accordingly. Copyright © 2015 by the Endocrine Society.

Objective: To describe an optimized protocol for oocyte in vitro maturation (IVM) that achieves improved implantation and ongoing pregnancy rates in women with polycystic ovaries (PCO) and polycystic ovary syndrome (PCOS). Design: Prospective cohort study. Setting: Hospital fertility unit. Patient(s): Women with PCO and PCOS undergoing treatment for infertility. Intervention(s): Follicle-stimulating hormone (FSH) priming, IVM, blastocyst culture, hormone replacement therapy. Main Outcome Measure(s): Clinical pregnancy rates. Result(s): Our optimized IVM protocol achieves implantation and ongoing pregnancy rates comparable to in vitro fertilization. From 66 oocyte collections, 844 oocytes were collected (12.8 oocytes/cycle), 588 oocytes matured after IVM (69.7% maturation rate), 420 oocytes fertilized after ICSI (71.4% fertilization rate), and 175 blastocyst-stage embryos resulted (41.7% blastocyst-development rate). Of these, 62 blastocyst-stage embryos were transferred as single embryos, resulting in 29 clinical pregnancies (43.9%/oocyte collection, 46.7%/embryo transfer) and 28 live births (42.4%/oocyte collection, 45.2%/embryo transfer). Conclusion(s): In women with PCO or PCOS, improved implantation, clinical pregnancy, and live-birth rates can be achieved after single-embryo transfer by the use of an optimized IVM protocol. © 2012 American Society for Reproductive Medicine, Published by Elsevier Inc.

Koranne R.,Bethesda Hospital
Minnesota medicine | Year: 2011

Long-term acute care hospitals (LTACHs) have a niche role in the health care system. They specialize in caring for patients who are ventilator-dependent, are on inpatient dialysis, or have multi-organ or multi-system failure, postsurgical or organ transplant complications, complex wounds that need care, or traumatic or acquired brain injury. Many physicians are unfamiliar with the work done by the interdisciplinary teams that serve these facilities.This article describes LTACHs and their approach to care.

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