Between Pregnancy and Motherhood: Identifying Unmet Mental Health Needs in Pregnant Women with Lifetime Adversity

ERIC Educational Resources Information Center

Narayan, Angela J.; Thomas, Melanie; Nau, Melissa; Rivera, Luisa M.; Harris, William W.; Bernstein, Rosemary E.; Castro, Gloria; Lieberman, Alicia F.; Gantt, Tahnee

2017-01-01

The prenatal period represents an opportunity to buffer the intergenerational transmission of adversity through integrated, comprehensive perinatal health services for women experiencing high levels of adversity and clinical symptoms. This article presents preliminary descriptive data, drawn from an ongoing clinical research study, on prenatal…

A comparison of the survival and implantation rates of blastocysts that were vitrified on post-fertilization day five, six and seven.

PubMed

Berrin, Avci; Isıl, Kasapoglu; Baris, Ata; Goktan, Kuspinar; Seda, Saribal; Gurkan, Uncu

2018-05-03

The goal of this retrospective cohort study was to compare survival, implantation, clinical and ongoing pregnancy rates between blastocysts that were vitrified on post-fertilization days 5, 6 and 7. Before vitrification, blastocysts were evaluated in terms of morphology and blastocyst expansion, inner cell mass and trophectoderm quality. They were thawed and transfered in a subsequent artificial cycle. Embryo implantation rates were 39%, 25% and 25% for blastocysts that were vitrified on days 5, 6, and 7, respectively (p = 0.006). Clinical and ongoing pregnancy rates were 19%, 12%, 13% (p = 0.100) and 9%, 7%, 12% (p = 0.99) for days 5, 6 and 7 blastocysts, respectively. Day 5 blastocysts had significantly higher full-collapsing score after assisted-hatching compared to days 6 and 7 blastocysts (p = 0.014). As blastocyst quality increased, implantation and clinical pregnancy rates increased in all groups and both parameters were statistically significantly higher on day 5 blastocysts than on days 6 or 7 (p = 0.001). It was clearly found that good quality blastocysts obtained on day 5 have higher implantation and clinical pregnancy rates than 6th and 7th day cryopreserved embryos. There were no statistically significant differences between the cryopreserved embryos on days 6 and 7 regarding the implantation, clinic and ongoing pregnancy rates.

Human embryonic curvature studied with 3D ultrasound in ongoing pregnancies and miscarriages.

PubMed

Bogers, Hein; van Uitert, Evelyne M; van Ginkel, Sharon; van der Mooren, Elisabeth D H; Groenenberg, Irene A L; Eilers, Paul H C; Exalto, Niek; Steegers, Eric A P; Steegers-Theunissen, Régine P M

2018-05-01

Embryonic growth is often impaired in miscarriages. It is postulated that derangements in embryonic growth result in abnormalities of the embryonic curvature. This study aims to create first trimester reference charts of the human embryonic curvature and investigate differences between ongoing pregnancies and miscarriages. Weekly ultrasonographic scans from ongoing pregnancies and miscarriages were used from the Rotterdam periconceptional cohort and a cohort of recurrent miscarriages. In 202 ongoing pregnancies and 33 miscarriages, first trimester crown rump length and total arch length were measured to assess the embryonic curvature. The results show that the total arch length increases and shows more variation with advanced gestation. The crown rump length/total arch length ratio shows a strong increase from 8 +0 to 10 +0 weeks and flattening thereafter. No significant difference was observed between the curvature of embryos of ongoing pregnancies and miscarriages. The majority of miscarried embryos could not be measured. Therefore, this technique is too limited to recommend the measurement of the embryonic curvature in clinical practice. Copyright © 2018 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

Systemic and Topical Use of Tranexamic Acid in Spinal Surgery: A Systematic Review

PubMed Central

Winter, Sebastian F.; Santaguida, Carlo; Wong, Jean; Fehlings, Michael G.

2015-01-01

Study Design Combination of narrative and systematic literature reviews. Objectives Massive perioperative blood loss in complex spinal surgery often requires blood transfusions and can negatively affect patient outcome. Systemic use of the antifibrinolytic agent tranexamic acid (TXA) has become widely used in the management of surgical bleeding. We review the clinical evidence for the use of intravenous TXA as a hemostatic agent in spinal surgery and discuss the emerging role for its complementary use as a topical agent to reduce perioperative blood loss from the surgical site. Through a systematic review of published and ongoing investigations on topical TXA for spinal surgery, we wish to make spine practitioners aware of this option and to suggest opportunities for further investigation in the field. Methods A narrative review of systemic TXA in spinal surgery and topical TXA in surgery was conducted. Furthermore, a systematic search (using PRISMA guidelines) of PubMed (MEDLINE), EMBASE, and Cochrane CENTRAL databases as well as World Health Organization International Clinical Trials Registry Platform, ClinicalTrials.gov (National Institutes of Health), and International Standard Randomized Controlled Trial Number registries was conducted to identify both published literature and ongoing clinical trials on topical TXA in spinal surgery. Results Of 1,631 preliminary search results, 2 published studies were included in the systematic review. Out of 285 ongoing clinical trials matching the search criteria, a total of 4 relevant studies were included and reviewed. Conclusion Intravenous TXA is established as an efficacious hemostatic agent in spinal surgery. Use of topical TXA in surgery suggests similar hemostatic efficacy and potentially improved safety as compared with intravenous TXA. For spinal surgery, the literature on topical TXA is sparse but promising, warranting further clinical investigation and consideration as a clinical option in cases with significant anticipated surgical site blood loss. PMID:27099820

Long-term ongoing pregnancy rate and mode of conception after a positive and negative post-coital test.

PubMed

Hessel, Marloes; Brandes, Monique; de Bruin, Jan Peter; Bots, Rob S G M; Kremer, Jan A M; Nelen, Willianne L D M; Hamilton, Carl J C M

2014-09-01

Many fertility clinics have decided to abolish the post-coital test. Yet, it is a significant factor in prognostic models that predict the spontaneous pregnancy rate within one year. The aim of this study was to evaluate (1) the long-term outcome of infertile couples with a positive or a negative post-coital test during their fertility work-up and (2) the contribution of the different modes of conception. Retrospective cohort study. Three fertility clinics in the Netherlands, of which two are secondary care training hospitals and is a one tertiary care academic training hospital. 2476 newly referred infertile couples, where a post-coital test was performed in 1624 couples. After basic fertility work-up, couples were treated according to the national treatment protocols. Spontaneous and overall ongoing pregnancy rate. The spontaneous and overall ongoing pregnancy rates after three years were 37.7 and 77.5% after a positive post-coital test compared with 26.9 and 68.8% after a negative test (p < 0.001). Even in couples with severe male factor infertility (total motile sperm count <3) (p = 0.005) and mild male factor infertility (total motile sperm count 3-20) (p < 0.001), there was a significantly higher spontaneous ongoing pregnancy rate, justifying expectant management. After a follow-up of three years a positive post-coital test is still associated with a higher spontaneous and a higher overall ongoing pregnancy rate, even in couples with severe male factor infertility. © 2014 Nordic Federation of Societies of Obstetrics and Gynecology.

Are all after-hours diagnostic imaging appropriate? An Australian Emergency Department pilot study.

PubMed

Gardiner, Fergus William; Zhai, Shaun

2016-12-01

This study was aimed at determining the extent to which after-hours diagnostic imaging is appropriate within the case hospital's Emergency Department. This was amid growing concerns of the inappropriateness of some medical investigations within the Australian health-care system. After-hours referral data and patient notes were used in reviewing the clinical case. Diagnostic imaging was deemed appropriate if reflective of clinical guidelines, and if not reflective, whether the investigation changed the patient's ongoing management. Results indicated that 96.37% of after-hours diagnostic imaging adhered to clinical guidelines and was appropriately requested, with 95.85% changing the ongoing management of the patient. The most sought after diagnostic imaging procedures were Chest X-Ray (30.83%), and CT Brain (16.58%), with 99.16% and 98.44 appropriateness respectively. Chest pain (14.49%) and motor vehicle accidents (8.12%) were the leading reason for ordering after-hours imaging. This study provided an Emergency Department example as it relates to after-hours diagnostic imaging appropriateness. This study found that most after-hours referrals were appropriate.

Evaluation of an Ongoing Diabetes Group Medical Visit in a Family Medicine Practice.

PubMed

Cunningham, Amy T; Delgado, David J; Jackson, Joseph D; Crawford, Albert G; Jabbour, Serge; Lieberthal, Robert D; Diaz, Victor; LaNoue, Marianna

2018-01-01

Group medical visits (GMVs), which combine 1-on-1 clinical consultations and group self-management education, have emerged as a promising vehicle for supporting type 2 diabetes management in primary care. However, few evaluations exist of ongoing diabetes GMVs embedded in medical practices. This study used a quasi-experimental design to evaluate diabetes GMV at a large family medicine practice. We examined program attendance and attrition, used propensity score matching to create a matched comparison group, and compared participants and the matched group on clinical, process of care, and utilization outcomes. GMV participants (n = 230) attended an average of 1 session. Participants did not differ significantly from the matched comparison group (n = 230) on clinical, process of care or utilization outcomes. The diabetes GMV was not associated with improvements in outcomes. Further studies should examine diabetes GMV implementation challenges to enhance their effectiveness in everyday practice. © Copyright 2018 by the American Board of Family Medicine.

Integration of technology-based outcome measures in clinical trials of Parkinson and other neurodegenerative diseases.

PubMed

Artusi, Carlo Alberto; Mishra, Murli; Latimer, Patricia; Vizcarra, Joaquin A; Lopiano, Leonardo; Maetzler, Walter; Merola, Aristide; Espay, Alberto J

2018-01-01

We sought to review the landscape of past, present, and future use of technology-based outcome measures (TOMs) in clinical trials of neurodegenerative disorders. We systematically reviewed PubMed and ClinicalTrials.gov for published and ongoing clinical trials in neurodegenerative disorders employing TOMs. In addition, medical directors of selected pharmaceutical companies were surveyed on their companies' ongoing efforts and future plans to integrate TOMs in clinical trials as primary, secondary, or exploratory endpoints. We identified 164 published clinical trials indexed in PubMed that used TOMs as outcome measures in Parkinson disease (n = 132) or other neurodegenerative disorders (n = 32). The ClinicalTrials.gov search yielded 42 clinical trials using TOMs, representing 2.7% of ongoing trials. Sensor-based technology accounted for over 75% of TOMs applied. Gait and physical activity were the most common targeted domains. Within the next 5 years, 83% of surveyed pharmaceutical companies engaged in neurodegenerative disorders plan to deploy TOMs in clinical trials. Although promising, TOMs are underutilized in clinical trials of neurodegenerative disorders. Validating relevant endpoints, standardizing measures and procedures, establishing a single platform for integration of data and algorithms from different devices, and facilitating regulatory approvals should advance TOMs integration into clinical trials. Copyright © 2017 Elsevier Ltd. All rights reserved.

Common Data Elements for Clinical Research in Friedreich Ataxia

PubMed Central

Lynch, David R.; Pandolfo, Massimo; Schulz, Jorg B.; Perlman, Susan; Delatycki, Martin B.; Payne, R. Mark; Shaddy, Robert; Fischbeck, Kenneth H.; Farmer, Jennifer; Kantor, Paul; Raman, Subha V.; Hunegs, Lisa; Odenkirchen, Joanne; Miller, Kristy; Kaufmann, Petra

2012-01-01

Background To reduce study start-up time, increase data sharing, and assist investigators conducting clinical studies, the National Institute of Neurological Disorders and Stroke embarked on an initiative to create common data elements for neuroscience clinical research. The Common Data Element Team developed general common data elements which are commonly collected in clinical studies regardless of therapeutic area, such as demographics. In the present project, we applied such approaches to data collection in Friedreich ataxia, a neurological disorder that involves multiple organ systems. Methods To develop Friedreich’s ataxia common data elements, Friedreich’s ataxia experts formed a working group and subgroups to define elements in: Ataxia and Performance Measures; Biomarkers; Cardiac and Other Clinical Outcomes; and Demographics, Laboratory Tests and Medical History. The basic development process included: Identification of international experts in Friedreich’s ataxia clinical research; Meeting via teleconference to develop a draft of standardized common data elements recommendations; Vetting of recommendations across the subgroups; Dissemination of recommendations to the research community for public comment. Results The full recommendations were published online in September 2011 at http://www.commondataelements.ninds.nih.gov/FA.aspx. The Subgroups’ recommendations are classified as core, supplemental or exploratory. Template case report forms were created for many of the core tests. Conclusions The present set of data elements should ideally lead to decreased initiation time for clinical research studies and greater ability to compare and analyze data across studies. Their incorporation into new and ongoing studies will be assessed in an ongoing fashion to define their utility in Friedreich’s ataxia. PMID:23239403

Effectiveness of an Ongoing, Community-Based Breast Cancer Prevention Program for Korean American Women.

PubMed

Koh, Eun; Choi, Ga-Young; Cho, Ji Young

2016-02-01

The study evaluates the effectiveness of an ongoing, community-based breast cancer prevention program offered by a local social services agency in the Washington, DC, metropolitan area. Korean American women who participated in this breast cancer prevention program were compared with those who did not participate in their knowledge, attitude, and screening behaviors. The study found that the intervention group was more knowledgeable on breast cancer and related services and reported more positive attitudes toward breast cancer screening services than the comparison group. The participants in the intervention group were also more likely to plan to receive a mammogram than those in the comparison group. However, significant differences were not observed in the two groups in their intention to receive a clinical breast examination. The study findings suggest that an ongoing, community-based breast cancer prevention program can be an effective method of addressing breast cancer prevention disparities observed among Korean American women.

Placebo effect in clinical trial design for irritable bowel syndrome.

PubMed

Shah, Eric; Pimentel, Mark

2014-04-30

Ongoing efforts to improve clinical trial design in irritable bowel syndrome have been hindered by high placebo response rates and ineffective outcome measures. We assessed established strategies to minimize placebo effect as well as the various ap-proaches to placebo effect which can affect trial design. These include genetic markers such as catechol-O-methyltransferase, opioidergic and dopaminergic neurobiologic theory, pre-cebo effect centered on expectancy theory, and side effect unblinding grounded on conditioning theory. We reviewed endpoints used in the study of IBS over the past decade including adequate relief and subjective global relief, emphasizing their weaknesses in fully evaluating the IBS condition, specifically their motility effects based on functional net value and relative benefit-harm based on dropouts due to adverse events. The focus of this review is to highlight ongoing efforts to improve clinical trial design which can lead to better outcomes in a real-world setting.

Translating Alcohol Research

PubMed Central

Batman, Angela M.; Miles, Michael F.

2015-01-01

Alcohol use disorder (AUD) and its sequelae impose a major burden on the public health of the United States, and adequate long-term control of this disorder has not been achieved. Molecular and behavioral basic science research findings are providing the groundwork for understanding the mechanisms underlying AUD and have identified multiple candidate targets for ongoing clinical trials. However, the translation of basic research or clinical findings into improved therapeutic approaches for AUD must become more efficient. Translational research is a multistage process of streamlining the movement of basic biomedical research findings into clinical research and then to the clinical target populations. This process demands efficient bidirectional communication across basic, applied, and clinical science as well as with clinical practitioners. Ongoing work suggests rapid progress is being made with an evolving translational framework within the alcohol research field. This is helped by multiple interdisciplinary collaborative research structures that have been developed to advance translational work on AUD. Moreover, the integration of systems biology approaches with collaborative clinical studies may yield novel insights for future translational success. Finally, appreciation of genetic variation in pharmacological or behavioral treatment responses and optimal communication from bench to bedside and back may strengthen the success of translational research applications to AUD. PMID:26259085

Translating Alcohol Research: Opportunities and Challenges.

PubMed

Batman, Angela M; Miles, Michael F

2015-01-01

Alcohol use disorder (AUD) and its sequelae impose a major burden on the public health of the United States, and adequate long-term control of this disorder has not been achieved. Molecular and behavioral basic science research findings are providing the groundwork for understanding the mechanisms underlying AUD and have identified multiple candidate targets for ongoing clinical trials. However, the translation of basic research or clinical findings into improved therapeutic approaches for AUD must become more efficient. Translational research is a multistage process of stream-lining the movement of basic biomedical research findings into clinical research and then to the clinical target populations. This process demands efficient bidirectional communication across basic, applied, and clinical science as well as with clinical practitioners. Ongoing work suggests rapid progress is being made with an evolving translational framework within the alcohol research field. This is helped by multiple interdisciplinary collaborative research structures that have been developed to advance translational work on AUD. Moreover, the integration of systems biology approaches with collaborative clinical studies may yield novel insights for future translational success. Finally, appreciation of genetic variation in pharmacological or behavioral treatment responses and optimal communication from bench to bedside and back may strengthen the success of translational research applications to AUD.

Dietary patterns and the phenotype of polycystic ovary syndrome: the chance of ongoing pregnancy.

PubMed

Huijgen, Nicole A; Louwers, Yvonne V; Willemsen, Sten P; de Vries, Jeanne H M; Steegers-Theunissen, Régine P M; Laven, Joop S E

2017-06-01

Polycystic ovary syndrome (PCOS) is generally considered a complex disorder caused by interactions between genetic and environmental factors. In a sub-cohort of women with PCOS visiting the preconception outpatient clinic of a tertiary hospital with follow-up in a periconception cohort, we identified specific dietary patterns and adherence in patients with PCOS with and without hyperandrogenism and the chance of ongoing pregnancy. Food frequency questionnaires were available from 55 patients diagnosed with PCOS during follow-up in routine clinical practice, including 25 with hyperandrogenism and 30 without hyperandrogenism. Strong adherence to the healthy dietary pattern was inversely associated with the hyperandrogenic PCOS phenotype (Adjusted OR 0.27; 95% CI 0.07 to 0.99). In women with PCOS overall, a strong adherence to the healthy dietary pattern showed a three-fold higher chance of ongoing pregnancy (adjusted OR 3.38; 95% CI 1.01 to 11.36) and an association with anti-Müllerian hormone concentration (β -0.569 µg/L; 95% CI -0.97 to -0.17). The effect of this dietary pattern on the chance of ongoing pregnancy and AMH suggests causality, which needs further investigation in prospective studies in the general population. Copyright © 2017 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

Clinical trials in rheumatoid arthritis: a status report from the ClinicalTrials.gov website.

PubMed

Paul, Jisna R; Ranganathan, Prabha

2012-06-01

The aims of this study are to describe the characteristics of clinical trials in rheumatoid arthritis (RA) listed in ClinicalTrials.gov and examine existing trends in study design, funding sources, outcomes, and drugs under investigation. We conducted a survey of ongoing clinical trials in RA registered in the ClinicalTrials.gov website. We used the advanced search option and applied the following inclusion criteria, "rheumatoid arthritis", "open studies", "interventional", and "adults 18 years or older". Of 127 eligible trials, 53.5% of the studies were either phase 3 or 4, and 40.2% were phase 1, 2, and 2/3. Two-thirds of the trials were randomized (70.9%), and over half were, in addition, double-blinded (53.5%) and placebo-controlled (53.5%). Universities were listed as the primary sponsor for 18.9% of the trials and pharmaceutical industry for 73.2%. Majority of the trials were multi-center studies (93%) conducted outside the United States (54.3%). The most frequently used endpoint was drug efficacy (54.3%) followed by drug safety (25.2%). Most industry-funded trials were open for less than 12 months, whereas most university-funded trials were open for more than 24 months (58% each). Biologic therapies were the focus of most trials in the registry (78.5%). Randomized, double-blinded, placebo-controlled, phase 3 and 4 trials form the majority of ongoing clinical trials in RA. The preponderance of industry funding of RA trials and the short duration of such trials are troubling trends which need to be addressed.

Avelumab: a new standard for treating metastatic Merkel cell carcinoma.

PubMed

Baker, Mairead; Cordes, Lisa; Brownell, Isaac

2018-04-01

Merkel cell carcinoma (MCC) is a rare and aggressive skin cancer. Although MCC is chemosensitive, responses to traditional chemotherapeutic agents are not durable. Avelumab, a novel anti-PD-L1 immune checkpoint inhibitor, recently became the first FDA-approved agent for the treatment of metastatic MCC and represents a new option to improve patient survival. Areas covered: This article presents an overview of MCC and summarizes the development of avelumab in the treatment of metastatic MCC. Preclinical studies, phase 1 and phase 2 clinical trials, and the safety profile of avelumab are reviewed. Future perspectives and ongoing studies are also discussed. Expert commentary: Avelumab demonstrated rapid and durable responses and a manageable safety profile in the treatment of metastatic MCC. Patient outcomes are favorable when compared to historical responses to standard chemotherapy. Ongoing clinical trials will continue to characterize avelumab and its optimal use in MCC therapy.

New treatment directions for IPF: current status of ongoing and upcoming clinical trials.

PubMed

Macagno, Francesco; Varone, Francesco; Leone, Paolo Maria; Mari, Pier-Valerio; Panico, Loredana; Berardini, Ludovica; Richeldi, Luca

2017-07-01

The main objective of this review is to explore the wide and expanding field of new clinical trials in IPF. Recent trials have confirmed the efficacy of the approved drugs pirfenidone and nintedanib; nonetheless, the discovery of new biological pathways has opened new horizons in this field. Areas covered: New strategies against matrix deposition are under study and so is for the role of immunity and autoimmunity. Recent advances in the use of stem cells are opening new possibilities for the recovery of damaged lung tissues. The role of microbioma is under investigation in order to evaluate the use of antibiotics in IPF treatment. Analysing all the new and the upcoming clinical trials, we are trying to offer a comprehensive view of the emerging new frontiers in the treatment of IPF. Expert commentary: The key points for the ongoing and upcoming clinical trials will be to avoid previous mistakes and to choose carefully both study populations and efficacy endpoints. The exciting possibility to enrol patients with progressive lung fibrosis, both idiopathic and not, could be a next step forward. How the existing therapies will fit in a futurist scenario of personalized medicine is still a challenge.

Immune Checkpoint Inhibition in Hepatocellular Carcinoma: Basics and Ongoing Clinical Trials.

PubMed

Kudo, Masatoshi

2017-01-01

Clinical trials of antibodies targeting the immune checkpoint inhibitors programmed cell death 1 (PD-1), programmed cell death ligand 1 (PD-L1), or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) for the treatment of advanced hepatocellular carcinoma (HCC) are ongoing. Expansion cohorts of a phase I/II trial of the anti-PD-1 antibody nivolumab in advanced HCC showed favorable results. Two phase III studies are currently ongoing: a comparison of nivolumab and sorafenib in the first-line setting for advanced HCC, and a comparison of the anti-PD-1 antibody pembrolizumab and a placebo in the second-line setting for patients with advanced HCC who progressed on sorafenib therapy. The combination of anti-PD-1/PD-L1 and anti-CTLA-4 antibodies is being evaluated in other phase I/II trials, and the results suggest that an anti-PD-1 antibody combined with locoregional therapy or other molecular targeted agents is an effective treatment strategy for HCC. Immune checkpoint inhibitors may therefore open new doors to the treatment of HCC. © 2017 S. Karger AG, Basel.

ICU nurses and physicians dialogue regarding patients clinical status and care options—a focus group study

PubMed Central

Kvande, Monica; Lykkeslet, Else; Storli, Sissel Lisa

2017-01-01

ABSTRACT Nurses and physicians work side-by-side in the intensive care unit (ICU). Effective exchanges of patient information are essential to safe patient care in the ICU. Nurses often rate nurse-physician communication lower than physicians and report that it is difficult to speak up, that disagreements are not resolved and that their input is not well received. Therefore, this study explored nurses’ dialogue with physicians regarding patients’ clinical status and the prerequisites for effective and accurate exchanges of information. We adopted a qualitative approach, conducting three focus group discussions with five to six nurses and physicians each (14 total). Two themes emerged. The first theme highlighted nurses’ contributions to dialogues with physicians; nurses’ ongoing observations of patients were essential to patient care discussions. The second theme addressed the prerequisites of accurate and effective dialogue regarding care options, comprising three subthemes: nurses’ ability to speak up and present clinical changes, establishment of shared goal and clinical understanding, and open dialogue and willingness to listen to each other. Nurses should understand their essential role in conducting ongoing observations of patients and their right to be included in care-related decision-making processes. Physicians should be willing to listen to and include nurses’ clinical observations and concerns. PMID:28452605

ICU nurses and physicians dialogue regarding patients clinical status and care options-a focus group study.

PubMed

Kvande, Monica; Lykkeslet, Else; Storli, Sissel Lisa

2017-12-01

Nurses and physicians work side-by-side in the intensive care unit (ICU). Effective exchanges of patient information are essential to safe patient care in the ICU. Nurses often rate nurse-physician communication lower than physicians and report that it is difficult to speak up, that disagreements are not resolved and that their input is not well received. Therefore, this study explored nurses' dialogue with physicians regarding patients' clinical status and the prerequisites for effective and accurate exchanges of information. We adopted a qualitative approach, conducting three focus group discussions with five to six nurses and physicians each (14 total). Two themes emerged. The first theme highlighted nurses' contributions to dialogues with physicians; nurses' ongoing observations of patients were essential to patient care discussions. The second theme addressed the prerequisites of accurate and effective dialogue regarding care options, comprising three subthemes: nurses' ability to speak up and present clinical changes, establishment of shared goal and clinical understanding, and open dialogue and willingness to listen to each other. Nurses should understand their essential role in conducting ongoing observations of patients and their right to be included in care-related decision-making processes. Physicians should be willing to listen to and include nurses' clinical observations and concerns.

Prospective Randomized Trial Comparing Embryo Transfers of Cases with and without Catheter Rotation during Its Withdrawal.

PubMed

Yayla Abide, Cigdem; Ozkaya, Enis; Sanverdi, Ilhan; Bostancı Ergen, Evrim; Kurek Eken, Meryem; Devranoglu, Belgin; Bilgiç, Bulent Emre; Kilicci, Cetin; Kayatas Eser, Semra

2018-05-14

To compare embryo transfer (ET) technique based on catheter rotation during its withdrawal in cases with unexplained infertility in a prospective, randomized trial (NCT03097042). Two hundred intracytoplasmic sperm injection (ICSI) patients undergoing ET with cleaving or blastocyst-stage fresh embryos were randomized into 2 groups: cases with (n = 100), and without (n = 100) catheter rotation during its withdrawal. Groups were matched for age and some clinical parameters. A soft catheter was used to transfer a single embryo with catheter rotation during its withdrawal in the study group and without rotation in the control. The use of a stiff catheter or tenaculum was not needed in any case. Groups were compared in terms of cycle characteristics and clinical pregnancy rates. Pregnancy rate was significantly higher in the study group (41 vs. 26%, p = 0.04). Clinical pregnancy rate was also significantly higher in the study group (39 vs. 25%, OR 1.9 [1.1-3.5], p = 0.05). On the other hand, the ongoing pregnancy rate was similar between the 2 groups (33 vs. 23%, p = 0.2). Catheter rotation during its withdrawal may be associated with increased pregnancy and clinical pregnancy rates; however, the difference in ongoing pregnancy rates did not reach statistical significance. © 2018 S. Karger AG, Basel.

Everolimus as first line therapy for pancreatic neuroendocrine tumours: current knowledge and future perspectives.

PubMed

Gallo, Marco; Malandrino, Pasqualino; Fanciulli, Giuseppe; Rota, Francesca; Faggiano, Antongiulio; Colao, Annamaria

2017-07-01

Everolimus has been shown to be effective for advanced pancreatic neuroendocrine tumours (pNETs), but its positioning in the therapeutic algorithm for pNETs is matter of debate. With the aim to shed light on this point, we performed an up-to-date critical review taking into account the results of both retrospective and prospective published studies, and the recommendations of international guidelines. In addition, we performed an extensive search on the Clinical Trial Registries databases worldwide, to gather information on the ongoing clinical trials related to this specific topic. We identified eight retrospective published studies, two prospective published studies, and five registered clinical trials. Moreover, we analyzed the content of four widespread international guidelines. Our critical review confirms the lack of high-quality data to recommend everolimus as the first line therapy for pNETs. The ongoing clinical trials reported in this review will hopefully help clinicians, in the near future, to better evaluate the role of everolimus as the first line therapy for pNETs. However, at the moment, there is already enough evidence to recommend everolimus as the first line therapy for patients with symptomatic malignant unresectable insulin-secreting pNETs, to control the endocrine syndrome regardless of tumour growth.

Immune checkpoint blockade: the role of PD-1-PD-L axis in lymphoid malignancies

PubMed Central

Ilcus, Cristina; Bagacean, Cristina; Tempescul, Adrian; Popescu, Cristian; Parvu, Andrada; Cenariu, Mihai; Bocsan, Corina; Zdrenghea, Mihnea

2017-01-01

The co-inhibitory receptor programmed cell death (PD)-1, expressed by immune effector cells, is credited with a protective role for normal tissue during immune responses, by limiting the extent of effector activation. Its presently known ligands, programmed death ligands (PD-Ls) 1 and 2, are expressed by a variety of cells including cancer cells, suggesting a role for these molecules as an immune evasion mechanism. Blocking of the PD-1-PD-L signaling axis has recently been shown to be effective and was clinically approved in relapsed/refractory tumors such as malignant melanoma and lung cancer, but also classical Hodgkin’s lymphoma. A plethora of trials exploring PD-1 blockade in cancer are ongoing. Here, we review the role of PD-1 signaling in lymphoid malignancies, and the latest results of trials investigating PD-1 or PD-L1 blocking agents in this group of diseases. Early phase studies proved very promising, leading to the clinical approval of a PD-1 blocking agent in Hodgkin’s lymphoma, and Phase III clinical studies are either planned or ongoing in most lymphoid malignancies. PMID:28496333

Discrepancies between ClinicalTrials.gov recruitment status and actual trial status: a cross-sectional analysis.

PubMed

Jones, Christopher W; Safferman, Michelle R; Adams, Amanda C; Platts-Mills, Timothy F

2017-10-11

To determine the accuracy of the recruitment status listed on ClinicalTrials.gov as compared with the actual trial status. Cross-sectional analysis. Random sample of interventional phase 2-4 clinical trials registered between 2010 and 2012 on ClinicalTrials.gov. For each trial which was listed within ClinicalTrials.gov as ongoing, two investigators performed a comprehensive literature search for evidence that the trial had actually been completed. For each trial listed as completed or terminated early by ClinicalTrials.gov, we compared the date that the trial was actually concluded with the date the registry was updated to reflect the study's conclusion status. Among the 405 included trials, 92 had a registry status indicating that study activity was either ongoing or the recruitment status was unknown. Of these, published results were available for 34 (37%). Among the 313 concluded trials, the median delay between study completion and a registry update reflecting that the study had ended was 141 days (IQR 48-419), with delays of over 1 year present for 29%. In total, 125 trials (31%) either had a listed recruitment status which was incorrect or had a delay of more than 1 year between the time the study was concluded and the time the registry recruitment status was updated. At present, registry recruitment status information in ClinicalTrials.gov is often outdated or wrong. This inaccuracy has implications for the ability of researchers to identify completed trials and accurately characterise all available medical knowledge on a given subject. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Prevalence of clinical trial status discrepancies: A cross-sectional study of 10,492 trials registered on both ClinicalTrials.gov and the European Union Clinical Trials Register.

PubMed

Fleminger, Jessica; Goldacre, Ben

2018-01-01

Trial registries are a key source of information for clinicians and researchers. While building OpenTrials, an open database of public trial information, we identified errors and omissions in registries, including discrepancies between descriptions of the same trial in different registries. We set out to ascertain the prevalence of discrepancies in trial completion status using a cohort of trials registered on both the European Union Clinical Trials Register (EUCTR) and ClinicalTrials.gov. We used matching titles and registry IDs provided by both registries to build a cohort of dual-registered trials. Completion statuses were compared; we calculated descriptive statistics on the prevalence of discrepancies. 11,988 dual-registered trials were identified. 1,496 did not provide a comparable completion status, leaving 10,492 trials. 16.2% were discrepant on completion status. The majority of discrepancies (90.5%) were a 'completed' trial on ClinicalTrials.gov inaccurately marked as 'ongoing' on EUCTR. Overall, 33.9% of dual-registered trials described as 'ongoing' on EUCTR were listed as 'completed' on ClinicalTrials.gov. Completion status on registries is commonly inaccurate. Previous work on publication bias may underestimate non-reporting. We describe simple steps registry owners and trialists could take to improve accuracy.

76 FR 77545 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-13

... Diseases Special Emphasis Panel, Ancillary Studies to Major Ongoing Clinical Studies CKD. Date: January 9... Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, Nutrition Obesity Research... and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases...

"The Power of Being Seen": An Interpretative Phenomenological Analysis of How Experienced Counselling Psychologists Describe the Meaning and Significance of Personal Therapy in Clinical Practice

ERIC Educational Resources Information Center

Rizq, Rosemary; Target, Mary

2008-01-01

There is a widely acknowledged lack of clarity in psychotherapeutic training about the role of personal therapy in developing practitioner competence. This paper presents part of a wider ongoing qualitative study exploring the role that personal therapy plays in the clinical practice and training of experienced counselling psychologists. Results…

Mechanisms of pain in distal symmetric polyneuropathy: a combined clinical and neurophysiological study.

PubMed

Truini, A; Biasiotta, A; La Cesa, S; Di Stefano, G; Galeotti, F; Petrucci, M T; Inghilleri, M; Cartoni, C; Pergolini, M; Cruccu, G

2010-09-01

In patients with distal symmetric polyneuropathy we assessed non-nociceptive Abeta- and nociceptive Adelta-afferents to investigate their role in the development of neuropathic pain. We screened 2240 consecutive patients with sensory disturbances and collected 150 patients with distal symmetric polyneuropathy (68 with pain and 82 without). All patients underwent the Neuropathic Pain Symptom Inventory to rate ongoing, paroxysmal and provoked pains, a standard nerve conduction study (NCS) to assess Abeta-fibre function, and laser-evoked potentials (LEPs) to assess Adelta-fibre function. Patients with pain had the same age (P>0.50), but a longer delay since symptom onset than those without (P<0.01). Whereas the LEP amplitude was significantly lower in patients with pain than in those without (P<0.0001), NCS data did not differ between groups (P>0.50). LEPs were more severely affected in patients with ongoing pain than in those with provoked pain (P<0.0001). Our findings indicate that the impairment of Abeta-fibres has no role in the development of ongoing or provoked pain. In patients with ongoing pain the severe LEP suppression and the correlation between pain intensity and LEP attenuation may indicate that this type of pain reflects damage to nociceptive axons. The partially preserved LEPs in patients with provoked pain suggest that this type of pain is related to the abnormal activity arising from partially spared and sensitised nociceptive terminals. Because clinical and neurophysiological abnormalities followed similar patterns regardless of aetiology, pain should be classified and treated on mechanism-based grounds. Copyright (c) 2010 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

78 FR 78373 - National Institute of Diabetes and Digestive and Kidney Diseases Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-26

... Ongoing Clinical Studies in NIDDK (RO1): CKD and Diabetic Nephropathy. Date: February 20, 2014. Time: 4:00... and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases...

On-going clinical trials for elderly patients with a hematological malignancy: are we addressing the right end points?

PubMed

Hamaker, M E; Stauder, R; van Munster, B C

2014-03-01

Cancer societies and research cooperative groups worldwide have urged for the development of cancer trials that will address those outcome measures that are most relevant to older patients. We set out to determine the characteristics and study objectives of current clinical trials in hematological patients. The United States National Institutes of Health clinical trial registry was searched on 1 July 2013, for currently recruiting phase I, II or III clinical trials in hematological malignancies. Trial characteristics and study objectives were extracted from the registry website. In the 1207 clinical trials included in this overview, patient-centered outcome measures such as quality of life, health care utilization and functional capacity were only incorporated in a small number of trials (8%, 4% and 0.7% of trials, respectively). Even in trials developed exclusively for older patients, the primary focus lies on standard end points such as toxicity, efficacy and survival, while patient-centered outcome measures are included in less than one-fifth of studies. Currently on-going clinical trials in hematological malignancies are unlikely to significantly improve our knowledge of the optimal treatment of older patients as those outcome measures that are of primary importance to this patient population are still included in only a minority of studies. As a scientific community, we cannot continue to simply acknowledge this issue, but must all participate in taking the necessary steps to enable the delivery of evidence-based, tailor-made and patient-focused cancer care to our rapidly growing elderly patient population.

On-going clinical trials for elderly patients with a hematological malignancy: are we addressing the right end points?†

PubMed Central

Hamaker, M. E.; Stauder, R.; van Munster, B. C.

2014-01-01

Background Cancer societies and research cooperative groups worldwide have urged for the development of cancer trials that will address those outcome measures that are most relevant to older patients. We set out to determine the characteristics and study objectives of current clinical trials in hematological patients. Method The United States National Institutes of Health clinical trial registry was searched on 1 July 2013, for currently recruiting phase I, II or III clinical trials in hematological malignancies. Trial characteristics and study objectives were extracted from the registry website. Results In the 1207 clinical trials included in this overview, patient-centered outcome measures such as quality of life, health care utilization and functional capacity were only incorporated in a small number of trials (8%, 4% and 0.7% of trials, respectively). Even in trials developed exclusively for older patients, the primary focus lies on standard end points such as toxicity, efficacy and survival, while patient-centered outcome measures are included in less than one-fifth of studies. Conclusion Currently on-going clinical trials in hematological malignancies are unlikely to significantly improve our knowledge of the optimal treatment of older patients as those outcome measures that are of primary importance to this patient population are still included in only a minority of studies. As a scientific community, we cannot continue to simply acknowledge this issue, but must all participate in taking the necessary steps to enable the delivery of evidence-based, tailor-made and patient-focused cancer care to our rapidly growing elderly patient population. PMID:24458474

Clinical Trials | Division of Cancer Prevention

Cancer.gov

Information about actively enrolling, ongoing, and completed clinical trials of cancer prevention, early detection, and supportive care, including phase I, II, and III agent and action trials and clinical trials management. |

Twenty-five years of accomplishments of the College of American Pathologists Q-probes program for clinical pathology.

PubMed

Howanitz, Peter J; Perrotta, Peter L; Bashleben, Christine P; Meier, Frederick A; Ramsey, Glenn E; Massie, Larry W; Zimmerman, Roberta L; Karcher, Donald S

2014-09-01

During the past 25 years, the College of American Pathologists' (CAP) Q-Probes program has been available as a subscription program to teach laboratorians how to improve the quality of clinical laboratory services. To determine the accomplishments of the CAP Q-Probes program. We reviewed Q-Probes participant information, study data and conclusions, author information, and program accomplishments. During this time 117 Q-Probes clinical pathology studies were conducted by 54 authors and coauthors, 42,899 laboratories enrolled from 24 countries, 98 peer-reviewed publications occurred and were cited more than 1600 times, and the studies were featured 59 times in CAP Today. The most frequent studies (19) focused on turnaround times for results or products at specific locations (emergency department, operating room, inpatients, outpatients), specific diseases (acute myocardial infarction, urinary tract), availability for specific events such as morning rounds or surgery, a specific result (positive blood cultures), and a method on how to use data for improvement (stat test outliers). Percentile ranking of study participants with better performance provided benchmarks for each study with attributes statistically defined that influenced improved performance. Other programs, such as an ongoing quality improvement program (Q-Tracks), a laboratory competency assessment program, a pathologist certification program, and an ongoing physician practice evaluation program (Evalumetrics), have been developed from Q-Probes studies. The CAP's Q-Probes program has made significant contributions to the medical literature and has developed a worldwide reputation for improving the quality of clinical pathology services worldwide.

Sustained inflation during neonatal resuscitation.

PubMed

Keszler, Martin

2015-04-01

Sustained inflation performed shortly after birth to help clear lung fluid and establish functional residual capacity in preterm infants is gaining popularity, but definitive evidence for its effectiveness is lacking. Although there is a sound physiologic basis for this approach, and much preclinical experimental evidence of effectiveness, the results of recent animal studies and clinical trials have been inconsistent. The most recent data from a multicenter randomized trial suggest a modest benefit of sustained inflation in reducing the need for mechanical ventilation in extremely-low-birth-weight infants. However, the impact may be more modest than earlier retrospective cohort comparisons suggested. The trend toward more airleak and a higher rate of intraventricular hemorrhage is worrisome. Sustained inflation may be ineffective unless some spontaneous respiratory effort is present. Several on-going trials should further clarify the putative benefits of sustained inflation. Delivery room sustained inflation is an attractive concept that holds much promise, but widespread clinical application should await definitive evidence from on-going clinical trials.

What's in a Label? Is Diagnosis the Start or the End of Clinical Reasoning?

PubMed

Ilgen, Jonathan S; Eva, Kevin W; Regehr, Glenn

2016-04-01

Diagnostic reasoning has received substantial attention in the literature, yet what we mean by "diagnosis" may vary. Diagnosis can align with assignment of a "label," where a constellation of signs, symptoms, and test results is unified into a solution at a single point in time. This "diagnostic labeling" conceptualization is embodied in our case-based learning curricula, published case reports, and research studies, all of which treat diagnostic accuracy as the primary outcome. However, this conceptualization may oversimplify the richly iterative and evolutionary nature of clinical reasoning in many settings. Diagnosis can also represent a process of guiding one's thoughts by "making meaning" from data that are intrinsically dynamic, experienced idiosyncratically, negotiated among team members, and rich with opportunities for exploration. Thus, there are two complementary constructions of diagnosis: 1) the correct solution resulting from a diagnostic reasoning process, and 2) a dynamic aid to an ongoing clinical reasoning process. This article discusses the importance of recognizing these two conceptualizations of "diagnosis," outlines the unintended consequences of emphasizing diagnostic labeling as the primary goal of clinical reasoning, and suggests how framing diagnosis as an ongoing process of meaning-making might change how we think about teaching and assessing clinical reasoning.

Time course of ongoing activity during neuritis and following axonal transport disruption.

PubMed

Satkeviciute, Ieva; Goodwin, George; Bove, Geoffrey M; Dilley, Andrew

2018-05-01

Local nerve inflammation (neuritis) leads to ongoing activity and axonal mechanical sensitivity (AMS) along intact nociceptor axons and disrupts axonal transport. This phenomenon forms the most feasible cause of radiating pain, such as sciatica. We have previously shown that axonal transport disruption without inflammation or degeneration also leads to AMS but does not cause ongoing activity at the time point when AMS occurs, despite causing cutaneous hypersensitivity. However, there have been no systematic studies of ongoing activity during neuritis or noninflammatory axonal transport disruption. In this study, we present the time course of ongoing activity from primary sensory neurons following neuritis and vinblastine-induced axonal transport disruption. Whereas 24% of C/slow Aδ-fiber neurons had ongoing activity during neuritis, few (<10%) A- and C-fiber neurons showed ongoing activity 1-15 days following vinblastine treatment. In contrast, AMS increased transiently at the vinblastine treatment site, peaking on days 4-5 (28% of C/slow Aδ-fiber neurons) and resolved by day 15. Conduction velocities were slowed in all groups. In summary, the disruption of axonal transport without inflammation does not lead to ongoing activity in sensory neurons, including nociceptors, but does cause a rapid and transient development of AMS. Because it is proposed that AMS underlies mechanically induced radiating pain, and a transient disruption of axonal transport (as previously reported) leads to transient AMS, it follows that processes that disrupt axonal transport, such as neuritis, must persist to maintain AMS and the associated symptoms. NEW & NOTEWORTHY Many patients with radiating pain lack signs of nerve injury on clinical examination but may have neuritis, which disrupts axonal transport. We have shown that axonal transport disruption does not induce ongoing activity in primary sensory neurons but does cause transient axonal mechanical sensitivity. The present data complete a profile of key axonal sensitivities following axonal transport disruption. Collectively, this profile supports that an active peripheral process is necessary for maintained axonal sensitivities.

Evidence-based medicine in the treatment of peritoneal carcinomatosis: Past, present, and future.

PubMed

Nissan, Aviram; Stojadinovic, Alexander; Garofalo, Alfredo; Esquivel, Jesus; Piso, Pompiliu

2009-09-15

The current treatment of peritoneal surface malignancies (PSMs) is moving from a nihilistic approach, into a combined modality approach offering selected patients long-term survival. As primary PSM are rare, extrapolation of data from clinical trials of related disease is necessary to develop treatment guidelines. Secondary PSM are more common, and therefore, treatment guidelines should be developed based on prospective clinical trials. We reviewed the published and ongoing clinical trials studying the treatment of PSM. (c) 2009 Wiley-Liss, Inc.

The MMPI-2 in sexual harassment and discrimination litigants.

PubMed

Long, Barbara; Rouse, Steven V; Nelsen, R Owen; Butcher, James N

2004-06-01

In order to understand patterns of respondents on validity and clinical scales, this study analyzed archival Minnesota Multiphasic Personality Inventory 2s (MMPI-2s) produced by 192 women and 14 men who initiated legal claims of ongoing emotional harm related to workplace sexual harassment and discrimination. The MMPI-2s were administered as a part of a comprehensive psychiatric forensic evaluation of the claimants' current psychological condition. All validity and clinical scale scores were manually entered into the computer, and codetype and cluster analyses were obtained. Among the women, 28% produced a "normal limits" profile, providing no MMPI-2 support for their claims of ongoing emotional distress. Cluster analysis of the validity scales of the remaining profiles produced four distinctive clusters of profiles representing different approaches to the test items. Copyright 2004 Wiley Periodicals, Inc.

‘It's trying to manage the work’: a qualitative evaluation of recruitment processes within a UK multicentre trial

PubMed Central

Skea, Zoë Christina; Treweek, Shaun; Gillies, Katie

2017-01-01

Objectives To explore trial site staff's perceptions regarding barriers and facilitators to local recruitment. Design Qualitative semi-structured interviews with a range of trial site staff from four trial sites in the UK. Interviews were analysed thematically to identify common themes across sites, barriers that could be addressed and facilitators that could be shared with other sites. Participants 11 members of staff from four trial sites: clinical grant Co-applicant (n=1); Principal Investigators (n=3); Consultant Urologist (n=1); Research Nurses (n=5); Research Assistant (n=1). Setting Embedded within an ongoing randomised controlled trial (the TISU trial). TISU is a UK multicentre trial comparing therapeutic interventions for ureteric stones. Results Our study draws attention to the initial and ongoing burden of trial work that is involved throughout the duration of a clinical trial. In terms of building and sustaining a research culture, trial staff described the ongoing work of engagement that was required to ensure that clinical staff were both educated and motivated to help with the process of identifying and screening potential participants. Having adequate and sufficient organisational and staffing resources was highlighted as being a necessary prerequisite to successful recruitment both in terms of accessing potentially eligible patients and being able to maximise recruitment after patient identification. The nature of the research study design can also potentially generate challenging communicative work for recruiting staff which can prove particularly problematic. Conclusions Our paper adds to existing research highlighting the importance of the hidden and complex work that is involved in clinical trial recruitment. Those designing and supporting the operationalisation of clinical trials must recognise and support the mitigation of this ‘work’. While much of the work is likely to be contextually sensitive at the level of local sites and for individual trials, some aspects are ubiquitous issues for delivery of trials more generally. Trial registration number ISRCTN No 92289221; Pre-results. PMID:28801422

Directions in Near-Death Research.

ERIC Educational Resources Information Center

Lundahl, C.R.

1981-01-01

Explains that near-death research is moving in three directions: (1) the ongoing accumulation of knowledge on the near-death experience through scientifically derived studies; (2) the examination of post-mortem survival; and (3) the clinical application of the findings of near- death research. (Author/RC)

South Asian women with polycystic ovary syndrome exhibit greater sensitivity to gonadotropin stimulation with reduced fertilization and ongoing pregnancy rates than their Caucasian counterparts.

PubMed

Palep-Singh, M; Picton, H M; Vrotsou, K; Maruthini, D; Balen, A H

2007-10-01

Polycystic ovary syndrome (PCOS) is a heterogeneous syndrome. In vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) is required for PCOS cases that are refractory to standard ovulation induction or have co-existing infertility factors in women with PCOS and Tubal factor subfertility. Assess ethnic variations in response to IVF/ICSI treatment. Observational Comparative study in a University hospital fertility clinic in women with PCOS and Tubal factor subfertility. Women with PCOS (Asians: AP=104; Caucasians: CP=220) and those with tubal factor infertility seeking fertility treatment were assessed (Asians: AC=84; Caucasians: CC=200). Six hundred and eight fresh IVF or ICSI cycles using long protocol of GnRHa suppression and resulting in a fresh embryo transfer were compared. The primary endpoint was to assess the dose of gonadotropins used in the cycles. The secondary outcomes were: total number of oocytes retrieved, fertilization and ongoing clinical pregnancy rates. We found that the South Asian women presented at a younger age for the management of sub-fertility. An extended stimulation phase and Caucasian ethnicity showed an inverse correlation with the number of oocytes retrieved in the PCOS subgroup. Caucasian ethnicity was associated with a higher fertilization rate however increase in body mass index (BMI) and the laboratory technique of IVF appeared to have a negative impact on fertilization rates in the PCOS subgroup. Commencing down regulation on day 1 of the cycles was negatively associated with fertilization rates in the tubal group. In terms of clinical pregnancy rates, the Caucasian PCOS had a 2.5 times (95% CI: 1.25-5) higher chance of an ongoing clinical pregnancy as compared with their Asian counterpart. Also, a unit increase in the basal FSH concentration reduced the odds of pregnancy by 18.6% (95% CI: 1.8-32.6%) in the PCOS group. The Asian PCOS have a greater sensitivity to gonadotropin stimulation with lower fertilization and ongoing clinical pregnancy rates as compared with their Caucasian counterparts.

Acceptability and feasibility of phone follow-up with a semiquantitative urine pregnancy test after medical abortion in Moldova and Uzbekistan.

PubMed

Platais, Ingrida; Tsereteli, Tamar; Comendant, Rodica; Kurbanbekova, Dilfuza; Winikoff, Beverly

2015-02-01

To evaluate the feasibility and acceptability of phone follow-up with a home semiquantitative pregnancy test and standardized checklist, and compare the alternative method of follow-up with in-clinic follow-up after medical abortion. Two thousand four hundred women undergoing medical abortion with mifepristone and misoprostol in Moldova and Uzbekistan were randomized to phone or clinic follow-up. All women in the clinic group returned to the clinic 2 weeks later. Women randomized to phone follow-up used a semiquantitative pregnancy test at the initial visit and repeated the test at home 2 weeks later when they also filled out a symptom checklist. Women were called at 2 weeks to review the test results and checklist. Participants who screened "positive" were referred to clinic to verify abortion completion. Most women in the phone group were successfully contacted on the phone (97.6%). Staff were unable to contact one woman in the phone follow-up group, and all women in clinic group returned to the clinic. The ongoing pregnancy rate was similar in both groups (0.4-0.6%), and the semiquantitative pregnancy test identified all ongoing pregnancies in the phone follow-up group. Women in the phone group found the test and checklist easy to use, and most (76.1%) preferred phone follow-up in the future. Overall, 92.8% of women in the phone group did not undergo in-clinic follow-up. Phone follow-up with a semiquantitative urine pregnancy test and symptom checklist is a feasible and a highly effective approach in identifying ongoing pregnancy after medical abortion. The semiquantitative pregnancy test can make home follow-up after medical abortion possible for many women and provide reassurance that ongoing pregnancies will be detected. Copyright © 2015 Elsevier Inc. All rights reserved.

Status quo, issues, and challenges for acupuncture research evidence: an overview of clinical and fundamental studies.

PubMed

Cai, Yujia; Shen, Jiantong; Zhong, Dake; Li, Youping; Wu, Taixiang

2012-02-01

To systematically review the status quo, issues, and challenges from home and abroad for acupuncture research evidence, in order to identify global acupuncture research datum lines and policy-making evidence for future research direction. To carry out computed searching through the Cochrane Library, MEDLINE, CNKI, SCI, WHO-ICTRP, and Chinese Clinical Trials Registry (ChiCTR) (up to January, 2010) for acupuncture-related secondary studies (systematic reviews and meta-analysis), animal randomized controlled trials (RCTs), published human RCTs (fundamental research with the human body or human body specimens as subjects), and registered on-going clinical trials (regardless of subject recruiting), and to analyze yearly publishing trends and research hotspots on subject headings for secondary studies and published and registered RCTs. (1) 63.7% of acupuncture clinical RCTs were published in the Cochrane Central Register of Controlled Trials (CENTRAL), while RCTs published in MEDLINE, SCI, and CNKI each accounted for a third of all acupuncture fundamental RCTs. Publishing trends of acupuncture clinical RCTs indicated three periods - a period of slow growth before 1998, a period of gradual growth between 1999 and 2005, and a period of rapid growth after 2005. While few fundamental acupuncture RCTs were published before 2004, the period after 2005 demonstrated an increasing trend, but did not exhibit the same rapid growth as with clinical RCTs. Publication of Cochrane systematic reviews (CSRs) exhibited a time-dependent effect with acupuncture clinical RCTs, a trend that became more pronounced as time passed, while time intervals between CSR and acupuncture clinical RCT publications decreased. (2) Nine SRs were published in China, accounting for 30% of the global total of 29, while China's 68 RCTs accounted for 21% of global RCTs. Among five CSRs affirming the effects of acupuncture, only one contained four RCTs from China, which accounted for 10% of all RCTs included in that CSR. All information provided above demonstrates a deficiency of high-quality evidence from China affirming the efficiency of acupuncture. (3) Nine CSRs published by Chinese researchers included 38 RCTs (44%) from China, as well as 48 foreign RCTs; four of these CSRs included RCTs from China only. (4) Over 70% of acupuncture fundamental RCTs were carried out by China alone while only 11% of acupuncture clinical RCTs included in SCI were from China, both of which suggest the methodology quality of acupuncture clinical RCTs in China should be raised to meet international standards. (5) Clinical research was the primary focus of acupuncture studies in Europe and the US. (6) Acupuncture studies were divided into nine research areas according to the top 50 disease-related high-frequency words in acupuncture RCTs. The first three disease categories, comprehensively ranked using published clinical RCTs, were pain and analgesia, cardio-cerebrovascular diseases, and the neuropsychological system. The top three disease categories of both on-going clinical RCTs and acupuncture fundamental RCTs, respectively, were in accordance with those of published clinical RCTs. (1) CL CTRD is the key database in searching for published acupuncture clinical RCTs, and thus should be used first. Databases such as MEDLINE, SCI, and CNKI are all indispensable in retrieving acupuncture fundamental RCTs. (2) China leads the world in terms of both clinical and acupuncture fundamental RCTs, but while publication occurs rapidly, there is a lack of high-quality RCTs, suggesting future acupuncture clinical RCTs in China should place a higher emphasis on quality. Further development of acupuncture fundamental studies with little clinical research is a coming challenge for China. The US provides many of the RCTs published in SCI and on-going RCTs registered in WHO-ICTRP. Its small but high-quality publication will increasingly strengthen its impact on acupuncture research. (3) The fact that the top three disease categories of on-going clinical RCTs and of acupuncture fundamental RCTs, respectively, were in accordance with published clinical RCTs indicate that pain, cardio-cerebrovascular diseases, and neuropsychological diseases are major treatment disease categories for acupuncture and also primary development directions for the future. (4) CSRs will achieve synchronized updates with acupuncture clinical RCTs and its influence in guiding acupuncture clinical RCTs will grow clearer day by day. (5) Though registration of on-going RCTs is still in its initial stage and the number of RCTs registered is still relatively small, that the continued operation of the WHO-ICTRP will boost both the number of acupuncture RCTs registered and their quality. Innovation and time in acupuncture methodology will definitely advance the development of acupuncture research, while national and international cooperative programs in acupuncture research need evidence to support their claims throughout the course of project approval to implementation to inspection and acceptance to transformation to follow-up appraisal, in order to supply scientific and transparent research, thus improving credibility and practicality of the results. © 2012 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University.

75 FR 80062 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-21

... Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings Pursuant to section 10(d) of the... Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, Novel Therapies for NIDDM P01... Kidney Diseases Special Emphasis Panel, Ancillary Studies to major ongoing Clinical Research Studies in...

Measuring Family System Characteristics in Families Caring for Dementia Patients.

ERIC Educational Resources Information Center

Niederehe, George; And Others

This paper describes an ongoing study evaluating families that provide in-home care to elderly relatives wth dementia. Characteristics of the study, which include a focus on progressive senile dementia, use of a clinical approach, longitudinal design, descriptive nature, focus on the dyad of patient and primary caregiver, and use of videotaping…

Effects of adding alendronate to ongoing hormone therapy on bone mineral density in postmenopausal Korean women: a randomized, double-blind, placebo-controlled clinical trial.

PubMed

Min, Yong-Ki; Lee, Dong-Yun; Choi, Suk-Joo; Kim, Joo Han; Choi, DooSeok; Yoon, Byung-Koo

2013-07-01

This study was conducted to evaluate the effects of adding the bisphosphonate alendronate (ALEN) to ongoing hormone therapy (HT) on bone mineral density (BMD) in postmenopausal Korean women. This randomized, double-blind, placebo-controlled clinical trial at a university hospital included a total of 139 postmenopausal women who had low BMD after HT lasting at least 1 year. Women received either ALEN (10 mg/d) or placebo in combination with HT for 1 year. Changes in BMD and biochemical markers of bone turnover were evaluated. Lumbar spine and total hip BMDs increased significantly in both treatment groups after 1 year. The addition of ALEN, when compared with HT alone, did not produce a significant change in BMD at the lumbar spine (3.7% vs 4.3%) and total hip (2.2% vs 3.2%) after adjusting for controllable variables. Serum osteocalcin showed a similar change, but urinary deoxypyridinoline response differed between treatment groups. Compared with HT alone, the addition of ALEN to ongoing HT for 1 year does not make a difference in BMD among postmenopausal Korean women with low BMD.

Improving metabolic parameters of antipsychotic child treatment (IMPACT) study: rationale, design, and methods

PubMed Central

2013-01-01

Background Youth with serious mental illness may experience improved psychiatric stability with second generation antipsychotic (SGA) medication treatment, but unfortunately may also experience unhealthy weight gain adverse events. Research on weight loss strategies for youth who require ongoing antipsychotic treatment is quite limited. The purpose of this paper is to present the design, methods, and rationale of the Improving Metabolic Parameters in Antipsychotic Child Treatment (IMPACT) study, a federally funded, randomized trial comparing two pharmacologic strategies against a control condition to manage SGA-related weight gain. Methods The design and methodology considerations of the IMPACT trial are described and embedded in a description of health risks associated with antipsychotic-related weight gain and the limitations of currently available research. Results The IMPACT study is a 4-site, six month, randomized, open-label, clinical trial of overweight/obese youth ages 8–19 years with pediatric schizophrenia-spectrum and bipolar-spectrum disorders, psychotic or non-psychotic major depressive disorder, or irritability associated with autistic disorder. Youth who have experienced clinically significant weight gain during antipsychotic treatment in the past 3 years are randomized to either (1) switch antipsychotic plus healthy lifestyle education (HLE); (2) add metformin plus HLE; or (3) HLE with no medication change. The primary aim is to compare weight change (body mass index z-scores) for each pharmacologic intervention with the control condition. Key secondary assessments include percentage body fat, insulin resistance, lipid profile, psychiatric symptom stability (monitored independently by the pharmacotherapist and a blinded evaluator), and all-cause and specific cause discontinuation. This study is ongoing, and the targeted sample size is 132 youth. Conclusion Antipsychotic-related weight gain is an important public health issue for youth requiring ongoing antipsychotic treatment to maintain psychiatric stability. The IMPACT study provides a model for pediatric research on adverse event management using state-of-the art methods. The results of this study will provide needed data on risks and benefits of two pharmacologic interventions that are already being used in pediatric clinical settings but that have not yet been compared directly in randomized trials. Trial registration Clinical Trials.gov NCT00806234 PMID:23947389

Research Gaps in Wilderness Medicine.

PubMed

Tritz, Daniel; Dormire, Kody; Brachtenbach, Travis; Gordon, Joshua; Sanders, Donald; Gearheart, David; Crawford, Julia; Vassar, Matt

2018-05-18

Wilderness medicine involves the treatment of individuals in remote, austere environments. Given the high potential for injuries as well as the unique treatment modalities required in wilderness medicine, evidence-based clinical practice guidelines are necessary to provide optimal care. In this study, we identify evidence gaps from low-quality recommendations in wilderness medicine clinical practice guidelines and identify new/ongoing research addressing them. We included relevant clinical practice guidelines from the Wilderness Medical Society and obtained all 1C or 2C level recommendations. Patient/Problem/Population, intervention, comparison, outcome (PICO) questions were created to address each recommendation. Using 24 search strings, we extracted titles, clinical trial registry number, and recruitment status for 8899 articles. We categorized the articles by trial design to infer the effect they may have on future recommendations. Twelve clinical practice guidelines met inclusion criteria. From these we located 275 low-quality recommendations and used them to create 275 PICO questions. Thirty-three articles were relevant to the PICO questions. Heat-related illness had the highest number of relevant articles (n=9), but acute pain and altitude sickness had the most randomized clinical trials (n=6). Overall, few studies were being conducted to address research gaps in wilderness medicine. Heat-related illness had the most new or ongoing research, whereas no studies were being conducted to address gaps in eye injuries, basic wound management, or spine immobilization. Animals, cadavers, and mannequin research are useful in cases in which human evidence is difficult to obtain. Establishing research priorities is recommended for addressing research gaps identified by guideline panels. Copyright © 2018 Wilderness Medical Society. Published by Elsevier Inc. All rights reserved.

Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011.

PubMed

Rathi, Vinay K; Krumholz, Harlan M; Masoudi, Frederick A; Ross, Joseph S

2015-08-11

The US Food and Drug Administration (FDA) approves high-risk medical devices, those that support or sustain human life or present potential unreasonable risk to patients, via the Premarket Approval (PMA) pathway. The generation of clinical evidence to understand device safety and effectiveness is shifting from predominantly premarket to continual study throughout the total product life cycle. To characterize the clinical evidence generated for high-risk therapeutic devices over the total product life cycle. All clinical studies of high-risk therapeutic devices receiving initial market approval via the PMA pathway in 2010 and 2011 identified through ClinicalTrials.gov and publicly available FDA documents as of October 2014. Studies were characterized by type (pivotal, studies that served as the basis of FDA approval; FDA-required postapproval studies [PAS]; or manufacturer/investigator-initiated); premarket or postmarket; status (completed, ongoing, or terminated/unknown); and design features, including enrollment, comparator, and longest duration of primary effectiveness end point follow-up. In 2010 and 2011, 28 high-risk therapeutic devices received initial marketing approval via the PMA pathway. We identified 286 clinical studies of these devices: 82 (28.7%) premarket and 204 (71.3%) postmarket, among which there were 52 (18.2%) nonpivotal premarket studies, 30 (10.5%) pivotal premarket studies, 33 (11.5%) FDA-required PAS, and 171 (59.8%) manufacturer/investigator-initiated postmarket studies. Six of 33 (18.2%) PAS and 20 of 171 (11.7%) manufacturer/investigator-initiated postmarket studies were reported as completed. No postmarket studies were identified for 5 (17.9%) devices; 3 or fewer were identified for 13 (46.4%) devices overall. Median enrollment was 65 patients (interquartile range [IQR], 25-111), 241 patients (IQR, 147-415), 222 patients (IQR, 119-640), and 250 patients (IQR, 60-800) for nonpivotal premarket, pivotal, FDA-required PAS, and manufacturer/investigator-initiated postmarket studies, respectively. Approximately half of all studies used no comparator (pivotal: 13/30 [43.3%]; completed postmarket: 16/26 [61.5%]; ongoing postmarket: 70/153 [45.8%]). Median duration of primary effectiveness end point follow-up was 3.0 months (IQR, 3.0-12.0), 9.0 months (IQR, 0.3-12.0), and 12.0 months (IQR, 7.0-24.0) for pivotal, completed postmarket, and ongoing postmarket studies, respectively. Among high-risk therapeutic devices approved via the FDA PMA pathway, total product life cycle evidence generation varied in both the number and quality of premarket and postmarket studies, with approximately 13% of initiated postmarket studies completed between 3 and 5 years after FDA approval.

Methodological considerations in the design and implementation of clinical trials.

PubMed

Cirrincione, Constance T; Lavoie Smith, Ellen M; Pang, Herbert

2014-02-01

To review study design issues related to clinical trials led by oncology nurses, with special attention to those conducted within the cooperative group setting; to emphasize the importance of the statistician's role in the process of clinical trials. Studies available at clinicaltrials.gov using experimental designs that have been published in peer-reviewed journals; cooperative group trials are highlighted. The clinical trial is a primary means to test intervention efficacy. A properly designed and powered study with clear and measurable objectives is as important as the intervention itself. Collaboration among the study team, including the statistician, is central in developing and conducting appropriately designed studies. For optimal results, collaboration is an ongoing process that should begin early on. Copyright © 2014 Elsevier Inc. All rights reserved.

Investigational Antibody-Drug Conjugates for Treatment of B-lineage Malignancies.

PubMed

Herrera, Alex F; Molina, Arturo

2018-05-10

Antibody-drug conjugates (ADCs) are tripartite molecules consisting of a monoclonal antibody, a covalent linker, and a cytotoxic payload. ADC development has aimed to target the specificity inherent in antigen-antibody interactions to deliver potent cytotoxins preferentially to tumor cells and maximize antitumor activity and simultaneously minimize off-target toxicity. The earliest ADCs provided disappointing results in the clinic; however, the lessons learned regarding the need for human or humanized antibodies, more stable linkers, and greater potency payloads led to improved ADCs. Three ADCs, gemtuzumab ozogamicin, brentuximab vedotin (BV), and inotuzumab ozogamicin, have been approved for hematologic malignancies. Site-specific conjugation methods have now resulted in a new generation of more uniform, molecularly defined ADCs. These are expected to display improved in vivo properties and have recently entered the clinic. We reviewed investigational ADCs currently in clinical testing for the treatment of B-cell lineage malignancies, including leukemias, lymphomas, and multiple myeloma. The rationales for antigen targeting, data reported to date, current trial status, and preclinical results for several newer ADCs expected to enter first-in-human studies are presented. Owing to the large number of ongoing and reported BV clinical studies, only the studies of BV for diffuse large B-cell lymphoma and those combining BV with checkpoint inhibitors in B-lineage malignancies have been reviewed. With > 40 ongoing clinical trials and 7 investigational ADCs already having advanced to phase II studies, the role of ADCs in the armamentarium for the treatment of B-lineage malignancies continues to be elucidated. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Preclinical neuroprotective actions of xenon and possible implications for human therapeutics: a narrative review.

PubMed

Maze, Mervyn

2016-02-01

The purpose of this report is to facilitate an understanding of the possible application of xenon for neuroprotection in critical care settings. This narrative review appraises the literature assessing the efficacy and safety of xenon in preclinical models of acute ongoing neurologic injury. Databases of the published literature (MEDLINE® and EMBASE™) were appraised for peer-reviewed manuscripts addressing the use of xenon in both preclinical models and disease states of acute ongoing neurologic injury. For randomized clinical trials not yet reported, the investigators' declarations in the National Institutes of Health clinical trials website were considered. While not a primary focus of this review, to date, xenon cannot be distinguished as superior for surgical anesthesia over existing alternatives in adults. Nevertheless, studies in a variety of preclinical disease models from multiple laboratories have consistently shown xenon's neuroprotective properties. These properties are enhanced in settings where xenon is combined with hypothermia. Small randomized clinical trials are underway to explore xenon's efficacy and safety in clinical settings of acute neurologic injury where hypothermia is the current standard of care. According to the evidence to date, the neuroprotective efficacy of xenon in preclinical models and its safety in clinical anesthesia set the stage for the launch of randomized clinical trials to determine whether these encouraging neuroprotective findings can be translated into clinical utility.

Heavy metal and trace element concentrations in blood and follicular fluid affect ART outcome.

PubMed

Tolunay, Harun Egemen; Şükür, Yavuz Emre; Ozkavukcu, Sinan; Seval, Mehmet Murat; Ateş, Can; Türksoy, Vugar Ali; Ecemiş, Tolga; Atabekoğlu, Cem Somer; Özmen, Batuhan; Berker, Bülent; Sönmezer, Murat

2016-03-01

To assess the effects of heavy metal and trace element concentrations in blood and follicular fluid on assisted reproductive technology cycle outcome. A prospective study was conducted between January 2012 and July 2012 in a university hospital infertility clinic. One hundred and one patients with unexplained infertility who underwent intracytoplasmic sperm injection using GnRH-antagonist protocol were recruited. Concentrations of four toxic metals (Cd, Pb, Hg, As) and three trace elements (Cu, Zn, Fe) were measured both in blood and follicular fluid specimens. Patients were evaluated in two groups; the study group consisted of patients with ongoing pregnancy (n=20) and the reference group consisted of patients experienced assisted reproductive technology failure, miscarriage or biochemical pregnancy (n=81). Demographics and cycle parameters were comparable between the groups except for median number of day 3 Grade A embryos. Statistically significant negative correlations were found between blood Pb levels and number of MII oocytes, implantation, clinical pregnancy and ongoing pregnancy rates. Results of the log binomial regression revealed 2.2% lower risk for ongoing pregnancy for each 1μg/dL higher blood Pb concentration while holding the other variables in the model constant (RR 0.978; 95% CI 0.956-0.998; P=.041). Also, the results revealed 71.9% lower risk for ongoing pregnancy for each 1μg/dL higher follicular fluid Cu concentration while holding the other variables in the model constant (RR 0.288; 95% CI 0.085-0.92; P=.039). Blood concentrations of Pb and follicular fluid concentrations of Cu seem to have significant impacts on assisted reproductive technology cycle outcome. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

An ongoing multifamily group in a women's shelter.

PubMed

Rhodes, Rosetta M; Zelman, Arthur B

1986-01-01

A mental health clinic's consultation to a spouse abuse center led to formation of an ongoing multifamily group that included all residents of the shelter and their children of all ages. The theoretical framework is outlined and group dynamics are highlighted by case material focused on illustrating specific intervention techniques.

Dystrophin quantification and clinical correlations in Becker muscular dystrophy: implications for clinical trials.

PubMed

Anthony, Karen; Cirak, Sebahattin; Torelli, Silvia; Tasca, Giorgio; Feng, Lucy; Arechavala-Gomeza, Virginia; Armaroli, Annarita; Guglieri, Michela; Straathof, Chiara S; Verschuuren, Jan J; Aartsma-Rus, Annemieke; Helderman-van den Enden, Paula; Bushby, Katherine; Straub, Volker; Sewry, Caroline; Ferlini, Alessandra; Ricci, Enzo; Morgan, Jennifer E; Muntoni, Francesco

2011-12-01

Duchenne muscular dystrophy is caused by mutations in the DMD gene that disrupt the open reading frame and prevent the full translation of its protein product, dystrophin. Restoration of the open reading frame and dystrophin production can be achieved by exon skipping using antisense oligonucleotides targeted to splicing elements. This approach aims to transform the Duchenne muscular dystrophy phenotype to that of the milder disorder, Becker muscular dystrophy, typically caused by in-frame dystrophin deletions that allow the production of an internally deleted but partially functional dystrophin. There is ongoing debate regarding the functional properties of the different internally deleted dystrophins produced by exon skipping for different mutations; more insight would be valuable to improve and better predict the outcome of exon skipping clinical trials. To this end, we have characterized the clinical phenotype of 17 patients with Becker muscular dystrophy harbouring in-frame deletions relevant to on-going or planned exon skipping clinical trials for Duchenne muscular dystrophy and correlated it to the levels of dystrophin, and dystrophin-associated protein expression. The cohort of 17 patients, selected exclusively on the basis of their genotype, included 4 asymptomatic, 12 mild and 1 severe patient. All patients had dystrophin levels of >40% of control and significantly higher dystrophin (P = 0.013), β-dystroglycan (P = 0.025) and neuronal nitric oxide synthase (P = 0.034) expression was observed in asymptomatic individuals versus symptomatic patients with Becker muscular dystrophy. Furthermore, grouping the patients by deletion, patients with Becker muscular dystrophy with deletions with an end-point of exon 51 (the skipping of which could rescue the largest group of Duchenne muscular dystrophy deletions) showed significantly higher dystrophin levels (P = 0.034) than those with deletions ending with exon 53. This is the first quantitative study on both dystrophin and dystrophin-associated protein expression in patients with Becker muscular dystrophy with deletions relevant for on-going exon skipping trials in Duchenne muscular dystrophy. Taken together, our results indicate that all varieties of internally deleted dystrophin assessed in this study have the functional capability to provide a substantial clinical benefit to patients with Duchenne muscular dystrophy.

Dystrophin quantification and clinical correlations in Becker muscular dystrophy: implications for clinical trials

PubMed Central

Anthony, Karen; Cirak, Sebahattin; Torelli, Silvia; Tasca, Giorgio; Feng, Lucy; Arechavala-Gomeza, Virginia; Armaroli, Annarita; Guglieri, Michela; Straathof, Chiara S.; Verschuuren, Jan J.; Aartsma-Rus, Annemieke; Helderman-van den Enden, Paula; Bushby, Katherine; Straub, Volker; Sewry, Caroline; Ferlini, Alessandra; Ricci, Enzo; Morgan, Jennifer E.

2011-01-01

Duchenne muscular dystrophy is caused by mutations in the DMD gene that disrupt the open reading frame and prevent the full translation of its protein product, dystrophin. Restoration of the open reading frame and dystrophin production can be achieved by exon skipping using antisense oligonucleotides targeted to splicing elements. This approach aims to transform the Duchenne muscular dystrophy phenotype to that of the milder disorder, Becker muscular dystrophy, typically caused by in-frame dystrophin deletions that allow the production of an internally deleted but partially functional dystrophin. There is ongoing debate regarding the functional properties of the different internally deleted dystrophins produced by exon skipping for different mutations; more insight would be valuable to improve and better predict the outcome of exon skipping clinical trials. To this end, we have characterized the clinical phenotype of 17 patients with Becker muscular dystrophy harbouring in-frame deletions relevant to on-going or planned exon skipping clinical trials for Duchenne muscular dystrophy and correlated it to the levels of dystrophin, and dystrophin-associated protein expression. The cohort of 17 patients, selected exclusively on the basis of their genotype, included 4 asymptomatic, 12 mild and 1 severe patient. All patients had dystrophin levels of >40% of control and significantly higher dystrophin (P = 0.013), β-dystroglycan (P = 0.025) and neuronal nitric oxide synthase (P = 0.034) expression was observed in asymptomatic individuals versus symptomatic patients with Becker muscular dystrophy. Furthermore, grouping the patients by deletion, patients with Becker muscular dystrophy with deletions with an end-point of exon 51 (the skipping of which could rescue the largest group of Duchenne muscular dystrophy deletions) showed significantly higher dystrophin levels (P = 0.034) than those with deletions ending with exon 53. This is the first quantitative study on both dystrophin and dystrophin-associated protein expression in patients with Becker muscular dystrophy with deletions relevant for on-going exon skipping trials in Duchenne muscular dystrophy. Taken together, our results indicate that all varieties of internally deleted dystrophin assessed in this study have the functional capability to provide a substantial clinical benefit to patients with Duchenne muscular dystrophy. PMID:22102647

Recent neuroimaging, neurophysiological, and neuropathological advances for the understanding of NPC

PubMed Central

Benussi, Alberto; Cotelli, Maria Sofia; Padovani, Alessandro; Borroni, Barbara

2018-01-01

Niemann–Pick disease type C (NPC) is a rare autosomal recessive lysosomal storage disorder with extensive biological, molecular, and clinical heterogeneity. Recently, numerous studies have tried to shed light on the pathophysiology of the disease, highlighting possible disease pathways common to other neurodegenerative disorders, such as Alzheimer’s disease and frontotemporal dementia, and identifying possible candidate biomarkers for disease staging and response to treatment. Miglustat, which reversibly inhibits glycosphingolipid synthesis, has been licensed in the European Union and elsewhere for the treatment of NPC in both children and adults. A number of ongoing clinical trials might hold promise for the development of new treatments for NPC. The objective of the present work is to review and evaluate recent literature data in order to highlight the latest neuroimaging, neurophysiological, and neuropathological advances for the understanding of NPC pathophysiology. Furthermore, ongoing developments in disease-modifying treatments will be briefly discussed. PMID:29511534

Hepatocellular carcinoma treatment: a comparative review of emerging growth factor receptor antagonists.

PubMed

Lee, Su Jin; Lim, Ho Yeong

2017-06-01

Hepatocellular carcinoma (HCC) is a leading cause of death worldwide. Over the last decade, sorafenib has been the only available therapeutic option for advanced HCC, although regorafenib recently showed a survival benefit compared with placebo in a second-line setting. Areas covered: This review discusses key published and ongoing studies with targeted agents in HCC, molecular targets of HCC, the mechanism of resistance to sorafenib, and the role of biomarker-enriched clinical trials. Expert opinion: The multiplicity of drivers and the existence of substantial molecular heterogeneity limit the benefits of targeted therapies in HCC. Based on molecular biology developments, a few biomarker-enriched clinical trials that target candidate driver genes are ongoing, and the outcomes of these are highly anticipated. Poor availability of tumor tissue and tumor heterogeneity in patients with HCC make liquid biopsy a very attractive option, although this technique remains to be validated.

Effect of educational program on quality of life of patients with heart failure: a randomized clinical trial.

PubMed

Lakdizaji, Sima; Hassankhni, Hadi; Mohajjel Agdam, Alireza; Khajegodary, Mohammad; Salehi, Rezvanieh

2013-03-01

Heart failure is one of the most common cardiovascular diseases which decrease the quality of life. Most of the factors influencing the quality of life can be modified with educational interventions. Therefore, this study examined the impact of a continuous training program on quality of life of patients with heart failure. This randomized clinical trial study was conducted during May to August 2011. Forty four participants with heart failure referred to Shahid Madani's polyclinics of Tabriz were selected through convenient sampling method and were randomly allocated to two groups. The intervention group (n = 22) received ongoing training including one-to-one teaching, counseling sessions and phone calls over 3 months. The control group (n = 22) received routine care program. Data on quality of life was collected using the Minnesota Living with Heart Failure Questionnaire at baseline as well as three months later. The statistical tests showed significant differences in the physical, emotional dimensions and total quality of life in intervention group. But in control group, no significant differences were obtained. There was not any significant association in demographic characteristics and quality of life. Ongoing training programs can be effective in improving quality of life of patients with heart failure. Hence applying ongoing educational program as a non-pharmacological intervention can help to improve the quality of life of these patients.

77 FR 62520 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-15

... Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Ancillary Studies to Major Ongoing Clinical Research Studies. Date: November 14, 2012. Time: 3:00 p.m. to 4:30 p.m. Agenda: To review and... Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases...

A novel smart lighting clinical testbed.

PubMed

Gleason, Joseph D; Oishi, Meeko; Simkulet, Michelle; Tuzikas, Arunas; Brown, Lee K; Brueck, S R J; Karlicek, Robert F

2017-07-01

A real-time, feedback-capable, variable spectrum lighting system was recently installed at the University of New Mexico Hospital to facilitate biomedical research on the health impacts of lighting. The system consists of variable spectrum troffers, color sensors, occupancy sensors, and computing and communication infrastructure, and is the only such clinical facility in the US. The clinical environment posed special challenges for installation as well as for ongoing maintenance and operations. Pilot studies are currently underway to evaluate the effectiveness of the system to regulate circadian phase in subjects with delayed sleep-wake phase disorder.

Insights from clinical research completed during the west Africa Ebola virus disease epidemic

PubMed Central

Rojek, Amanda; Horby, Peter; Dunning, Jake

2018-01-01

The west Africa Ebola virus disease (EVD) epidemic was extraordinary in scale. Now that the epidemic has ended, it is a relevant time to examine published studies with direct relevance to clinical care and, more broadly, to examine the implications of the clinical research response mounted. Clinically relevant research includes literature detailing risk factors for and clinical manifestations of EVD, laboratory and other investigation findings in patients, experimental vaccine and therapeutic clinical trials, and analyses of survivor syndrome. In this Review, we discuss new insights from patient-oriented research completed during the west Africa epidemic, identify ongoing knowledge gaps, and suggest priorities for future research. PMID:28461209

Long-term survival and quality of life in dogs with clinical signs associated with a congenital portosystemic shunt after surgical or medical treatment.

PubMed

Greenhalgh, Stephen N; Reeve, Jenny A; Johnstone, Thurid; Goodfellow, Mark R; Dunning, Mark D; O'Neill, Emma J; Hall, Ed J; Watson, Penny J; Jeffery, Nick D

2014-09-01

To compare long-term survival and quality of life data in dogs with clinical signs associated with a congenital portosystemic shunt (CPSS) that underwent medical or surgical treatment. Prospective cohort study. 124 client-owned dogs with CPSS. Dogs received medical or surgical treatment without regard to signalment, clinical signs, or clinicopathologic results. Survival data were analyzed with a Cox regression model. Quality of life information, obtained from owner questionnaires, included frequency of CPSS-associated clinical signs (from which a clinical score was derived), whether owners considered their dog normal, and (for surgically treated dogs) any ongoing medical treatment for CPSS. A Mann-Whitney U test was used to compare mean clinical score data between surgically and medically managed dogs during predetermined follow-up intervals. 97 dogs underwent surgical treatment; 27 were managed medically. Median follow-up time for all dogs was 1,936 days. Forty-five dogs (24 medically managed and 21 surgically managed) died or were euthanized during the follow-up period. Survival rate was significantly improved in dogs that underwent surgical treatment (hazard ratio, 8.11; 95% CI, 4.20 to 15.66) than in those treated medically for CPSS. Neither age at diagnosis nor shunt type affected survival rate. Frequency of clinical signs was lower in surgically versus medically managed dogs for all follow-up intervals, with a significant difference between groups at 4 to 7 years after study entry. Surgical treatment of CPSS in dogs resulted in significantly improved survival rate and lower frequency of ongoing clinical signs, compared with medical management. Age at diagnosis did not affect survival rate and should not influence treatment choice.

Renal Denervation: a Field in Flux.

PubMed

Laffin, Luke J; Bakris, George L

2016-07-01

SYMPLICITY HTN-3 was a pivotal moment for renal denervation as a treatment option for resistant hypertension. Prior unblinded studies were called into question given the negative results of the first sham-controlled trial of renal denervation. Reevaluation of the renal denervation procedure demonstrated that a more precise approach was needed to adequately denervate the kidney. This new approach has been implemented in two ongoing clinical trials, one on and one off medications to assess the new procedure's efficacy and safety. These and other ongoing trials will be discussed in the context of older studies in this field. We focus on novel findings published following the release of SYMPLICITY HTN-3 data in early 2014 and look to the future of renal denervation in the treatment of primary hypertension.

Social-support needs among adolescents living with HIV in transition from pediatric to adult care in Cambodia: findings from a cross-sectional study.

PubMed

Toth, Graham; Mburu, Gitau; Tuot, Sovannary; Khol, Vohith; Ngin, Chanrith; Chhoun, Pheak; Yi, Siyan

2018-03-28

Understanding the circumstances of adolescents living with HIV is critical in designing adolescent-friendly services that will facilitate successful transition from pediatric to adult care. This study describes access, utilization and ongoing social support needs among adolescents living with HIV aged 15-17 in transition from pediatric to adult HIV care in Cambodia. A cross-sectional study was conducted among 328 adolescents, randomly selected from 11 antiretroviral therapy (ART) clinics across the country. Descriptive analyses were conducted to summarize their characteristics, access to social support and ongoing support needs among male and female adolescents. Mean age of the study participants was 15.8 (SD = 0.8) years. Just over half (55.2%) were male. Most had at least one deceased parent (mother 50.9%; father 60.5%), and majority were living with biological parents (40.8%) or relatives (49.3%). A third came from families with an ID poor card, and 21.0% were working for pay. Almost half (46.6%) reported that their family had received social support for their health care, including food support (76.5%), school allowance (62.1%), transport allowance to ART clinics (53.6%), psychosocial counseling (35.3%), vocational training (22.9%) or home visits (11.1%). Several ongoing social support needs were identified, including ongoing inability to cover health expenses unless they are supported by health insurance or health equity fund (55.0%). In addition, adolescents reported having been asked to come back earlier than their scheduled appointment (13.7%), having had to purchase their own drugs (2.7%), experiencing HIV stigma (32.0%), having been denied housing or food due to HIV (8.2%) or failing to attend school within the past month partly because of HIV (16.8%). Two-thirds did not have access to peer support groups. Social protection mechanisms are reaching some adolescents in need, while other remain without social support due to discontinuities in health and social care. Multi-sectoral interventions, supporting school attendance, adolescent-friendly clinic scheduling, reductions in child employment, mitigation of HIV-related stigma and strengthening of peer-to-peer support are required to improve coverage of social protection interventions for adolescents in transition.

Clinical utility and validity of minoxidil response testing in androgenetic alopecia.

PubMed

Goren, Andy; Shapiro, Jerry; Roberts, Janet; McCoy, John; Desai, Nisha; Zarrab, Zoulikha; Pietrzak, Aldona; Lotti, Torello

2015-01-01

Clinical response to 5% topical minoxidil for the treatment of androgenetic alopecia (AGA) is typically observed after 3-6 months. Approximately 40% of patients will regrow hair. Given the prolonged treatment time required to elicit a response, a diagnostic test for ruling out nonresponders would have significant clinical utility. Two studies have previously reported that sulfotransferase enzyme activity in plucked hair follicles predicts a patient's response to topical minoxidil therapy. The aim of this study was to assess the clinical utility and validity of minoxidil response testing. In this communication, the present authors conducted an analysis of completed and ongoing studies of minoxidil response testing. The analysis confirmed the clinical utility of a sulfotransferase enzyme test in successfully ruling out 95.9% of nonresponders to topical minoxidil for the treatment of AGA. © 2014 Wiley Periodicals, Inc.

Activation of mesocorticolimbic reward circuits for assessment of relief of ongoing pain: a potential biomarker of efficacy.

PubMed

Xie, Jennifer Y; Qu, Chaoling; Patwardhan, Amol; Ossipov, Michael H; Navratilova, Edita; Becerra, Lino; Borsook, David; Porreca, Frank

2014-08-01

Preclinical assessment of pain has increasingly explored operant methods that may allow behavioral assessment of ongoing pain. In animals with incisional injury, peripheral nerve block produces conditioned place preference (CPP) and activates the mesolimbic dopaminergic reward pathway. We hypothesized that activation of this circuit could serve as a neurochemical output measure of relief of ongoing pain. Medications commonly used clinically, including gabapentin and nonsteroidal anti-inflammatory drugs (NSAIDs), were evaluated in models of post-surgical (1 day after incision) or neuropathic (14 days after spinal nerve ligation [SNL]) pain to determine whether the clinical efficacy profile of these drugs in these pain conditions was reflected by extracellular dopamine (DA) release in the nucleus accumbens (NAc) shell. Microdialysis was performed in awake rats. Basal DA levels were not significantly different between experimental groups, and no significant treatment effects were seen in sham-operated animals. Consistent with clinical observation, spinal clonidine produced CPP and produced a dose-related increase in net NAc DA release in SNL rats. Gabapentin, commonly used to treat neuropathic pain, produced increased NAc DA in rats with SNL but not in animals with incisional, injury. In contrast, ketorolac or naproxen produced increased NAc DA in animals with incisional but not neuropathic pain. Increased extracellular NAc DA release was consistent with CPP and was observed selectively with treatments commonly used clinically for post-surgical or neuropathic pain. Evaluation of NAc DA efflux in animal pain models may represent an objective neurochemical assay that may serve as a biomarker of efficacy for novel pain-relieving mechanisms. Copyright © 2014 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

Clinical outcomes after IVF or ICSI using human blastocysts derived from oocytes containing aggregates of smooth endoplasmic reticulum.

PubMed

Itoi, Fumiaki; Asano, Yukiko; Shimizu, Masashi; Nagai, Rika; Saitou, Kanako; Honnma, Hiroyuki; Murata, Yasutaka

2017-04-01

In this study the clinical and neo-natal outcomes after transfer of blastocysts derived from oocytes containing aggregates of smooth endoplasmic reticulum (SER) were compared between IVF and intracytoplasmic sperm injection (ICSI) cycles. Clinical and neo-natal outcomes of blastocysts in cycles with at least one SER metaphase II oocyte (SER + MII; SER + cycles) did not significantly differ between the two insemination methods. When SER + MII were cultured to day 5/6, fertilization, embryo cleavage and blastocyst rates were not significantly different between IVF and ICSI cycles. In vitrified-warmed blastocyst transfer cycles, the clinical pregnancy rates from SER + MII in IVF and ICSI did not significantly differ. In this study, 52 blastocysts (27 IVF and 25 ICSI) derived from SER + MII were transferred, yielding 15 newborns (5 IVF and 10 ICSI) and no malformations. Moreover, 300 blastocysts (175 IVF and 125 ICSI) derived from SER-MII were transferred, yielding 55 newborns (24 IVF and 31 ICSI cycles). Thus, blastocysts derived from SER + cycles exhibited an acceptable ongoing pregnancy rate after IVF (n = 125) or ICSI (n = 117) cycles. In conclusion, blastocysts from SER + MII in both IVF and ICSI cycles yield adequate ongoing pregnancy rates with neo-natal outcomes that do not differ from SER-MII. Copyright © 2017 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

14th International Congress on Antiphospholipid Antibodies: task force report on antiphospholipid syndrome treatment trends.

PubMed

Erkan, Doruk; Aguiar, Cassyanne L; Andrade, Danieli; Cohen, Hannah; Cuadrado, Maria J; Danowski, Adriana; Levy, Roger A; Ortel, Thomas L; Rahman, Anisur; Salmon, Jane E; Tektonidou, Maria G; Willis, Rohan; Lockshin, Michael D

2014-06-01

Antiphospholipid Syndrome (APS) is characterized by vascular thrombosis and/or pregnancy morbidity occurring in patients with persistent antiphospholipid antibodies (aPL). The primary objective of the APS Treatment Trends Task Force, created as part of the 14th International Congress on aPL, was to systematically review the potential future treatment strategies for aPL-positive patients. The task force chose as future clinical research directions: a) determining the necessity for controlled clinical trials in venous thromboembolism with the new oral direct thrombin or anti-factor Xa inhibitors pending the results of the ongoing rivaroxaban in APS (RAPS) trial, and designing controlled clinical trials in other forms of thrombotic APS; b) systematically analyzing the literature as well as aPL/APS registries, and creating specific registries for non-warfarin/heparin anticoagulants; c) increasing recruitment for an ongoing primary thrombosis prevention trial, and designing secondary thrombosis and pregnancy morbidity prevention trials with hydroxychloroquine; d) determining surrogate markers to select patients for statin trials; e) designing controlled studies with rituximab and other anti-B-cell agents; f) designing mechanistic and clinical studies with eculizumab and other complement inhibitors; and g) chemically modifying peptide therapy to improve the half-life and minimize immunogenicity. The report also includes recommendations for clinicians who consider using these agents in difficult-to-manage aPL-positive patients. Copyright © 2014 Elsevier B.V. All rights reserved.

NCI 1st International Workshop on the Biology, Prevention, and Treatment of Relapse After Allogeneic Hematopoietic Stem Cell Transplantation: Summary and Recommendations from the Organizing Committee

PubMed Central

Bishop, Michael R.; Alyea, Edwin P.; Cairo, Mitchell S.; Falkenburg, J.H. Frederik; June, Carl H.; Kröger, Nicolaus; Little, Richard F.; Miller, Jeffrey S.; Pavletic, Steven Z.; Porter, David L.; Riddell, Stanley R.; van Besien, Koen; Wayne, Alan S.; Weisdorf, Daniel J.; Wu, Roy S.; Giralt, Sergio

2011-01-01

The First International Workshop on The Biology, Prevention, and Treatment of Relapse After Allogeneic Hematopoietic Stem Cell Transplantation was organized and convened to identify, prioritize, and coordinate future research activities related to relapse after allogeneic hematopoietic stem cell transplantation (alloHSCT). Each of the Workshop’s six working committees have published individual reports of ongoing basic, translational and clinical research and recommended areas for future research related to the areas of relapse biology, epidemiology, prevention and treatment. This document summarizes each of the committees’ recommendations and suggests three major initiatives for a coordinated research effort to address the problem of relapse after alloHSCT. The first is the need to establish multi-center correlative and clinical trials networks for basic/translational, epidemiological, and clinical research. Second, there is a need for a network of biorepositories for the collection of samples pre- and post-alloHSCT to aid in laboratory and clinical studies. Third, there should be further refinement, implementation, and study of the proposed Workshop disease-specific response and relapse definitions and the recommendations for monitoring of minimal residual disease. These recommendations, in coordination with ongoing research initiatives and transplant organizations, provide a research framework to rapidly and efficiently address the significant problem of relapse following alloHSCT. PMID:21224011

Automation and apps for clinical dental biomechanics.

PubMed

Adams, Bruce W

2016-09-01

The aim of this research summary is to introduce the current and ongoing work using smartphone video, tracking markers to measure musculoskeletal disorders of cranial and mandibular origin, and the potential significance of the technology to doctors and therapists. The MPA™ biomechanical measuring apps are in beta trials with various doctors and therapists. The technique requires substantial image processing and statistical analysis, best suited to server-side processing. A smartphone environment has enabled a virtual laboratory, which provides automated generation of graphics and in some cases automated interpretation. The system enables highly accurate real-time biomechanics studies using only a smartphone and tracking markers. Despite the technical challenges in setting up and testing of the virtual environment and with interpretation of clinical relevance, the trials have enabled a demonstration of real-time biomechanics studies. The technology has prompted a lot of discussion about the relevance of rapid assessment tools in clinical practice. It seems that a prior bias against motion tracking and its relevance is very strong with occlusion related use cases, yet there has been a general agreement about the use case for cranial movement tracking in managing complex issues related to the head, neck, and TMJ. Measurement of cranial and mandibular functions using a smartphone video as the input have been investigated. Ongoing research will depend upon doctors and therapists to provide feedback as to which uses are considered clinically relevant.

Comprehensive Study of Acute Effects and Recovery After Concussion

DTIC Science & Technology

2017-10-01

dimensional research model, this study integrates biomechanical, clinical, neurobiological, and neuroradiological markers of mTBI, with the ultimate goal...assessing balance, neurocognition, symptoms, and psychological health, which will be correlated with data from the Head Impact Telemetry system (HITS...been achieved with regard to an advanced platform and “pipeline” for MRI data processing, quality control and integration . Ongoing collaboration with

A Longitudinal Study in Children with Sequential Bilateral Cochlear Implants: Time Course for the Second Implanted Ear and Bilateral Performance

ERIC Educational Resources Information Center

Reeder, Ruth M.; Firszt, Jill B.; Cadieux, Jamie H.; Strube, Michael J.

2017-01-01

Purpose: Whether, and if so when, a second-ear cochlear implant should be provided to older, unilaterally implanted children is an ongoing clinical question. This study evaluated rate of speech recognition progress for the second implanted ear and with bilateral cochlear implants in older sequentially implanted children and evaluated localization…

Randomized comparison of next-generation sequencing and array comparative genomic hybridization for preimplantation genetic screening: a pilot study.

PubMed

Yang, Zhihong; Lin, James; Zhang, John; Fong, Wai Ieng; Li, Pei; Zhao, Rong; Liu, Xiaohong; Podevin, William; Kuang, Yanping; Liu, Jiaen

2015-06-23

Recent advances in next-generation sequencing (NGS) have provided new methods for preimplantation genetic screening (PGS) of human embryos from in vitro fertilization (IVF) cycles. However, there is still limited information about clinical applications of NGS in IVF and PGS (IVF-PGS) treatments. The present study aimed to investigate the effects of NGS screening on clinical pregnancy and implantation outcomes for PGS patients in comparison to array comparative genomic hybridization (aCGH) screening. This study was performed in two phases. Phase I study evaluated the accuracy of NGS for aneuploidy screening in comparison to aCGH. Whole-genome amplification (WGA) products (n = 164) derived from previous IVF-PGS cycles (n = 38) were retrospectively analyzed with NGS. The NGS results were then compared with those of aCGH. Phase II study further compared clinical pregnancy and implantation outcomes between NGS and aCGH for IVF-PGS patients. A total of 172 patients at mean age 35.2 ± 3.5 years were randomized into two groups: 1) NGS (Group A): patients (n = 86) had embryos screened with NGS and 2) aCGH (Group B): patients (n = 86) had embryos screened with aCGH. For both groups, blastocysts were vitrified after trophectoderm biopsy. One to two euploid blastocysts were thawed and transferred to individual patients primarily based on the PGS results. Ongoing pregnancy and implantation rates were compared between the two study groups. NGS detected all types of aneuploidies of human blastocysts accurately and provided a 100 % 24-chromosome diagnosis consistency with the highly validated aCGH method. Moreover, NGS screening identified euploid blastocysts for transfer and resulted in similarly high ongoing pregnancy rates for PGS patients compared to aCGH screening (74.7 % vs. 69.2 %, respectively, p >0.05). The observed implantation rates were also comparable between the NGS and aCGH groups (70.5 % vs. 66.2 %, respectively, p >0.05). While NGS screening has been recently introduced to assist IVF patients, this is the first randomized clinical study on the efficiency of NGS for preimplantation genetic screening in comparison to aCGH. With the observed high accuracy of 24-chromosome diagnosis and the resulting high ongoing pregnancy and implantation rates, NGS has demonstrated an efficient, robust high-throughput technology for PGS.

Trauma-Focused CBT for Youth who Experience Ongoing Traumas

PubMed Central

Cohen, Judith A.; Mannarino, Anthony P.; Murray, Laura A.

2011-01-01

Many youth experience ongoing trauma exposure, such as domestic or community violence. Clinicians often ask whether evidence-based treatments containing exposure components to reduce learned fear responses to historical trauma are appropriate for these youth. Essentially the question is, if youth are desensitized to their trauma experiences, will this in some way impair their responding to current or ongoing trauma? The paper addresses practical strategies for implementing one evidence-based treatment, Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for youth with ongoing traumas. Collaboration with local therapists and families participating in TF-CBT community and international programs elucidated effective strategies for applying TF-CBT with these youth. These strategies included: 1) enhancing safety early in treatment; 2) effectively engaging parents who experience personal ongoing trauma; and 3) during the trauma narrative and processing component focusing on a) increasing parental awareness and acceptance of the extent of the youths’ ongoing trauma experiences; b) addressing youths’ maladaptive cognitions about ongoing traumas; and c) helping youth differentiate between real danger and generalized trauma reminders. Case examples illustrate how to use these strategies in diverse clinical situations. Through these strategies TF-CBT clinicians can effectively improve outcomes for youth experiencing ongoing traumas. PMID:21855140

'It's trying to manage the work': a qualitative evaluation of recruitment processes within a UK multicentre trial.

PubMed

Skea, Zoë Christina; Treweek, Shaun; Gillies, Katie

2017-08-11

To explore trial site staff's perceptions regarding barriers and facilitators to local recruitment. Qualitative semi-structured interviews with a range of trial site staff from four trial sites in the UK. Interviews were analysed thematically to identify common themes across sites, barriers that could be addressed and facilitators that could be shared with other sites. 11 members of staff from four trial sites: clinical grant Co-applicant (n=1); Principal Investigators (n=3); Consultant Urologist (n=1); Research Nurses (n=5); Research Assistant (n=1). Embedded within an ongoing randomised controlled trial (the TISU trial). TISU is a UK multicentre trial comparing therapeutic interventions for ureteric stones. Our study draws attention to the initial and ongoing burden of trial work that is involved throughout the duration of a clinical trial. In terms of building and sustaining a research culture, trial staff described the ongoing work of engagement that was required to ensure that clinical staff were both educated and motivated to help with the process of identifying and screening potential participants. Having adequate and sufficient organisational and staffing resources was highlighted as being a necessary prerequisite to successful recruitment both in terms of accessing potentially eligible patients and being able to maximise recruitment after patient identification. The nature of the research study design can also potentially generate challenging communicative work for recruiting staff which can prove particularly problematic. Our paper adds to existing research highlighting the importance of the hidden and complex work that is involved in clinical trial recruitment. Those designing and supporting the operationalisation of clinical trials must recognise and support the mitigation of this 'work'. While much of the work is likely to be contextually sensitive at the level of local sites and for individual trials, some aspects are ubiquitous issues for delivery of trials more generally. ISRCTN No 92289221; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Managing multicentre clinical trials with open source.

PubMed

Raptis, Dimitri Aristotle; Mettler, Tobias; Fischer, Michael Alexander; Patak, Michael; Lesurtel, Mickael; Eshmuminov, Dilmurodjon; de Rougemont, Olivier; Graf, Rolf; Clavien, Pierre-Alain; Breitenstein, Stefan

2014-03-01

Multicentre clinical trials are challenged by high administrative burden, data management pitfalls and costs. This leads to a reduced enthusiasm and commitment of the physicians involved and thus to a reluctance in conducting multicentre clinical trials. The purpose of this study was to develop a web-based open source platform to support a multi-centre clinical trial. We developed on Drupal, an open source software distributed under the terms of the General Public License, a web-based, multi-centre clinical trial management system with the design science research approach. This system was evaluated by user-testing and well supported several completed and on-going clinical trials and is available for free download. Open source clinical trial management systems are capable in supporting multi-centre clinical trials by enhancing efficiency, quality of data management and collaboration.

Plasma Treatment for Severe Influenza Deemed Well-Tolerated in Clinical Study | Frederick National Laboratory for Cancer Research

Cancer.gov

The upcoming flu season is just around the corner, and an ongoing challenge for researchers has been how to best respond to cases of severe influenza in the event of an outbreak. The Frederick National Laboratory for Cancer Research has helped the Na

Facilitating cancer research using natural language processing of pathology reports.

PubMed

Xu, Hua; Anderson, Kristin; Grann, Victor R; Friedman, Carol

2004-01-01

Many ongoing clinical research projects, such as projects involving studies associated with cancer, involve manual capture of information in surgical pathology reports so that the information can be used to determine the eligibility of recruited patients for the study and to provide other information, such as cancer prognosis. Natural language processing (NLP) systems offer an alternative to automated coding, but pathology reports have certain features that are difficult for NLP systems. This paper describes how a preprocessor was integrated with an existing NLP system (MedLEE) in order to reduce modification to the NLP system and to improve performance. The work was done in conjunction with an ongoing clinical research project that assesses disparities and risks of developing breast cancer for minority women. An evaluation of the system was performed using manually coded data from the research project's database as a gold standard. The evaluation outcome showed that the extended NLP system had a sensitivity of 90.6% and a precision of 91.6%. Results indicated that this system performed satisfactorily for capturing information for the cancer research project.

Risk assessment and management of radiofrequency radiation exposure

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dabala, Dana; Surducan, Emanoil; Surducan, Vasile

2013-11-13

Radiofrequency radiation (RFR) industry managers, occupational physicians, security department, and other practitioners must be advised on the basic of biophysics and the health effects of RF electromagnetic fields so as to guide the management of exposure. Information on biophysics of RFR and biological/heath effects is derived from standard texts, literature and clinical experiences. Emergency treatment and ongoing care is outlined, with clinical approach integrating the circumstances of exposure and the patient's symptoms. Experimental risk assessment model in RFR chronic exposure is proposed. Planning for assessment and monitoring exposure, ongoing care, safety measures and work protection are outlining the proper management.

Risk assessment and management of radiofrequency radiation exposure

NASA Astrophysics Data System (ADS)

Dabala, Dana; Surducan, Emanoil; Surducan, Vasile; Neamtu, Camelia

2013-11-01

Radiofrequency radiation (RFR) industry managers, occupational physicians, security department, and other practitioners must be advised on the basic of biophysics and the health effects of RF electromagnetic fields so as to guide the management of exposure. Information on biophysics of RFR and biological/heath effects is derived from standard texts, literature and clinical experiences. Emergency treatment and ongoing care is outlined, with clinical approach integrating the circumstances of exposure and the patient's symptoms. Experimental risk assessment model in RFR chronic exposure is proposed. Planning for assessment and monitoring exposure, ongoing care, safety measures and work protection are outlining the proper management.

Does time-lapse imaging have favorable results for embryo incubation and selection compared with conventional methods in clinical in vitro fertilization? A meta-analysis and systematic review of randomized controlled trials.

PubMed

Chen, Minghao; Wei, Shiyou; Hu, Junyan; Yuan, Jing; Liu, Fenghua

2017-01-01

The present study aimed to undertake a review of available evidence assessing whether time-lapse imaging (TLI) has favorable outcomes for embryo incubation and selection compared with conventional methods in clinical in vitro fertilization (IVF). Using PubMed, EMBASE, Cochrane library and ClinicalTrial.gov up to February 2017 to search for randomized controlled trials (RCTs) comparing TLI versus conventional methods. Both studies randomized women and oocytes were included. For studies randomized women, the primary outcomes were live birth and ongoing pregnancy, the secondary outcomes were clinical pregnancy and miscarriage; for studies randomized oocytes, the primary outcome was blastocyst rate, the secondary outcome was good quality embryo on Day 2/3. Subgroup analysis was conducted based on different incubation and embryo selection between groups. Ten RCTs were included, four randomized oocytes and six randomized women. For oocyte-based review, the pool-analysis observed no significant difference between TLI group and control group for blastocyst rate [relative risk (RR) 1.08, 95% CI 0.94-1.25, I2 = 0%, two studies, including 1154 embryos]. The quality of evidence was moderate for all outcomes in oocyte-based review. For woman-based review, only one study provided live birth rate (RR 1,23, 95% CI 1.06-1.44,I2 N/A, one study, including 842 women), the pooled result showed no significant difference in ongoing pregnancy rate (RR 1.04, 95% CI 0.80-1.36, I2 = 59%, four studies, including 1403 women) between two groups. The quality of the evidence was low or very low for all outcomes in woman-based review. Currently there is insufficient evidence to support that TLI is superior to conventional methods for human embryo incubation and selection. In consideration of the limitations and flaws of included studies, more well designed RCTs are still in need to comprehensively evaluate the effectiveness of clinical TLI use.

Standardized Patients Provide a Reliable Assessment of Athletic Training Students' Clinical Skills

ERIC Educational Resources Information Center

Armstrong, Kirk J.; Jarriel, Amanda J.

2016-01-01

Context: Providing students reliable objective feedback regarding their clinical performance is of great value for ongoing clinical skill assessment. Since a standardized patient (SP) is trained to consistently portray the case, students can be assessed and receive immediate feedback within the same clinical encounter; however, no research, to our…

Waldenstrom Macroglobulinemia☆

PubMed Central

Leleu, Xavier; Roccaro, Aldo M.; Moreau, Anne-Sophie; Dupire, Sophie; Robu, Daniela; Gay, Julie; Hatjiharissi, Evdoxia; Burwik, Nicholas; Ghobrial, Irene M.

2011-01-01

In the past years, new developments have occurred both in the understanding of the biology of Waldenstrom Macroglobulinemia (WM) and in therapeutic options for WM. WM is a B-cell disorder characterized primarily by bone marrow infiltration with lymphoplasmacytic cells, along with demonstration of an IgM monoclonal gammopathy. Despite advances in therapy, WM remains incurable, with 5–6 years median overall survival of patients in symptomatic WM. Therapy is postponed for asymptomatic patients, and progressive anemia is the most common indication for initiation of treatment. The main therapeutic options include alkylating agents, nucleoside analogues, and rituximab. Studies involving combination chemotherapy are ongoing, and preliminary results are encouraging. No specific agent or regimen has been shown to be superior to another for treatment of WM. As such, novel therapeutic agents are needed for the treatment of WM. In ongoing efforts, we and others have sought to exploit advances made in the understanding of the biology of WM so as to better target therapeutics for this malignancy. These efforts have led to the development of several novel agents including the proteasome inhibitor bortezomib, and several Akt/mTor inhibitors, perifosine and Rad001, and immunomodulatory agents such as thalidomide and lenalidomide. Studies with monoclonal antibodies are ongoing and promising including the use of alemtuzumab, SGN-70, and the APRIL/BLYS blocking protein TACI-Ig atacicept. Other agents currently being tested in clinical trials include the PKC inhibitor enzastaurin, the natural product resveratrol, as well as the statin simvastatin. This report provides an update of the current preclinical studies and clinical efforts for the development of novel agents in the treatment of WM. PMID:18555588

Individualized decision-making in IVF: calculating the chances of pregnancy.

PubMed

van Loendersloot, L L; van Wely, M; Repping, S; Bossuyt, P M M; van der Veen, F

2013-11-01

Are we able to develop a model to calculate the chances of pregnancy prior to the start of the first IVF cycle as well as after one or more failed cycles? Our prediction model enables the accurate individualized calculation of the probability of an ongoing pregnancy with IVF. To improve counselling, patient selection and clinical decision-making in IVF, a number of prediction models have been developed. These models are of limited use as they were developed before current clinical and laboratory protocols were established. This was a cohort study. The development set included 2621 cycles in 1326 couples who had been treated with IVF or ICSI between January 2001 and July 2009. The validation set included additional data from 515 cycles in 440 couples treated between August 2009 and April 2011. The outcome of interest was an ongoing pregnancy after transfer of fresh or frozen-thawed embryos from the same stimulated IVF cycle. If a couple became pregnant after an IVF/ICSI cycle, the follow-up was at a gestational age of at least 11 weeks. Women treated with IVF or ICSI between January 2001 and April 2011 in a university hospital. IVF/ICSI cycles were excluded in the case of oocyte or embryo donation, surgically retrieved spermatozoa, patients positive for human immunodeficiency virus, modified natural IVF and cycles cancelled owing to poor ovarian stimulation, ovarian hyperstimulation syndrome or other unexpected medical or non-medical reasons. Thirteen variables were included in the final prediction model. For all cycles, these were female age, duration of subfertility, previous ongoing pregnancy, male subfertility, diminished ovarian reserve, endometriosis, basal FSH and number of failed IVF cycles. After the first cycle: fertilization, number of embryos, mean morphological score per Day 3 embryo, presence of 8-cell embryos on Day 3 and presence of morulae on Day 3 were also included. In validation, the model had moderate discriminative capacity (c-statistic 0.68, 95% confidence interval: 0.63-0.73) but calibrated well, with a range from 0.01 to 0.56 in calculated probabilities. In our study, the outcome of interest was ongoing pregnancy. Live birth may have been a more appropriate outcome, although only 1-2% of all ongoing pregnancies result in late miscarriage or stillbirth. The model was based on data from a single centre. The IVF model presented here is the first to calculate the chances of an ongoing pregnancy with IVF, both for the first cycle and after any number of failed cycles. The generalizability of the model to other clinics has to be evaluated more extensively in future studies (geographical validation). Centres with higher or lower success rates could use the model, after recalibration, by adjusting the intercept to reflect the IVF success rates in their centre. This project was funded by the NutsOhra foundation (Grant 1004-179). The NutsOhra foundation had no role in the development of our study, in the collection, analysis and interpretation of data; in writing of the manuscript, and in the decision to submit the manuscript for publication. There were no competing interests.

Predictive probability methods for interim monitoring in clinical trials with longitudinal outcomes.

PubMed

Zhou, Ming; Tang, Qi; Lang, Lixin; Xing, Jun; Tatsuoka, Kay

2018-04-17

In clinical research and development, interim monitoring is critical for better decision-making and minimizing the risk of exposing patients to possible ineffective therapies. For interim futility or efficacy monitoring, predictive probability methods are widely adopted in practice. Those methods have been well studied for univariate variables. However, for longitudinal studies, predictive probability methods using univariate information from only completers may not be most efficient, and data from on-going subjects can be utilized to improve efficiency. On the other hand, leveraging information from on-going subjects could allow an interim analysis to be potentially conducted once a sufficient number of subjects reach an earlier time point. For longitudinal outcomes, we derive closed-form formulas for predictive probabilities, including Bayesian predictive probability, predictive power, and conditional power and also give closed-form solutions for predictive probability of success in a future trial and the predictive probability of success of the best dose. When predictive probabilities are used for interim monitoring, we study their distributions and discuss their analytical cutoff values or stopping boundaries that have desired operating characteristics. We show that predictive probabilities utilizing all longitudinal information are more efficient for interim monitoring than that using information from completers only. To illustrate their practical application for longitudinal data, we analyze 2 real data examples from clinical trials. Copyright © 2018 John Wiley & Sons, Ltd.

Sacubitril/Valsartan: A Novel Cardiovascular Combination Agent.

PubMed

Sible, Alexandra M; Nawarskas, James J; Alajajian, David; Anderson, Joe R

2016-01-01

Sacubitril/valsartan [LCZ696 (Entresto), Novartis Pharmaceuticals Corp.] is the first in a new class of drugs that combines neprilysin inhibition with angiotensin II receptor antagonism, the combination of which acts to increase endogenous natriuretic peptides while inhibiting the renin-angiotensin-aldosterone system. Sacubitril/valsartan has been studied in the treatment of hypertension, heart failure with reduced ejection fraction (HFrEF), and heart failure with preserved ejection fraction (HFpEF) and has demonstrated clinical efficacy in blood pressure reduction in hypertensive patients with and without HFpEF and a reduction in hospitalizations and mortality for patients with HFrEF. Research to evaluate clinical outcomes in HFpEF is ongoing. Sacubitril/valsartan is approved to reduce hospitalization and risk of cardiovascular death for patients with HFrEF in New York Heart Association (NYHA) functional class II-IV. The product is as well tolerated as an angiotensin-converting enzyme inhibitor, with the most common side effect being hypotension. Expectedly, it is much more costly than generic angiotensin-converting enzyme inhibitors or angiotensin receptor antagonists, which will be a factor in determining how widespread the use of this agent will be. In summary, although the number of published studies evaluating its use is limited, sacubitril/valsartan represents a promising new treatment option for patients with HFrEF. Ongoing studies will continue to refine the role of this agent in clinical practice.

[What's new in pediatric dermatology].

PubMed

Czernielewski, Justine; Hohl, Daniel

2015-04-01

Progress in paediatric dermatology is achieved in both research and therapeutic fields. In infectiology, scabies and bed bugs are a scourge for dermatologists, with an important recent outbreak. This article describes the fundamental clinical signs to look for, when suspecting such diagnosis. Hair dermatoscopy seems to be also very precious as a new tool for the diagnosis of ringworm. Regarding eczemas, atopic dermatitis is supported by S. Aureus's skin colonization, the target of eradication of new products in ongoing studies. We will also explain the role of Hemangiol, recently marketed in Switzerland for the treatment of haemangiomas. Alternative beta blockers have also a large number of ongoing projects in the dermatological vascular diseases field. Other various news is to be discovered....

Clinical validity of cerebrospinal fluid Aβ42, tau, and phospho-tau as biomarkers for Alzheimer's disease in the context of a structured 5-phase development framework.

PubMed

Mattsson, Niklas; Lönneborg, Anders; Boccardi, Marina; Blennow, Kaj; Hansson, Oskar

2017-04-01

Novel diagnostic criteria for Alzheimer's disease (AD) incorporate biomarkers, but their maturity for implementation in clinical practice at the prodromal stage (mild cognitive impairment [MCI]) is unclear. Here, we evaluate cerebrospinal fluid (CSF) β-amyloid 42 (Aβ42), total tau, and phosphorylated tau in the light of a 5-phase framework for biomarker development. Ample evidence is available for phase 1 (identifying useful leads) and phase 2 (assessing the accuracy for AD dementia versus controls) for CSF biomarkers. Phase 3 (utility in MCI) is partially achieved. In cohorts with long follow-up time, CSF Aβ42, total tau, and phosphorylated tau have high diagnostic accuracy for MCI due to AD. Phase 4 (performance in real world) is ongoing, and phase 5 studies (quantify impact and costs) are to come. Our results highlight priorities to pursue and to enable the proper use of CSF biomarkers in the clinic. Priorities are to reduce measurement variability by introduction of fully automated assay systems; to increase diagnostic specificity toward non-AD neurocognitive diseases at the MCI stage; and to clarify the role of CSF biomarkers versus other biomarker modalities in clinical practice and in design of clinical trials. These efforts are currently ongoing. Copyright © 2016 Elsevier Inc. All rights reserved.

Prevention of the Post-traumatic Fibrotic Response in Joints

DTIC Science & Technology

2014-10-01

an experimental model in mice. The American journal of forensic medicine and pathology . 1988; 9(4):310-2. 14 APPENDICES: An abstract...ongoing study addresses the critical clinical problem of posttraumatic joint stiffness, a pathology that reduces the range of motion (ROM) of injured...joints and contributes to the development of osteoarthritis. The fundamental hypothesis that drives the current study is that pathological fibrotic

The impact of benzodiazepine use on methadone maintenance treatment outcomes.

PubMed

Brands, Bruna; Blake, Joan; Marsh, David C; Sproule, Beth; Jeyapalan, Renuka; Li, Selina

2008-01-01

The purposes of this study were to examine predictors of benzodiazepine use among methadone maintenance treatment patients, to determine whether baseline benzodiazepine use influenced ongoing use during methadone maintenance treatment, and to assess the effect of ongoing benzodiazepine use on treatment outcomes (i.e., opioid and cocaine use and treatment retention). A retrospective chart review of 172 methadone maintenance treatment patients (mean age = 34.6 years; standard deviation = 8.5 years; 64% male) from January 1997 to December 1999 was conducted. At baseline, 29% were "non-users" (past year) of benzodiazepine, 36% were "occasional users," and 35% were "regular/problem users." Regular/problem users were more likely to have started opioid use with prescription opioids, experienced more overdoses, and reported psychiatric comorbidity. Being female, more years of opioid use, and a history of psychiatric treatment were significant predictors of baseline benzodiazepine use. Ongoing benzodiazepine users were more likely to have opioid-positive and cocaine-positive urine screens during methadone maintenance treatment. Only ongoing cocaine use was negatively related to retention. Benzodiazepine use by methadone maintenance treatment patients is associated with a more complex clinical picture and may negatively influence treatment outcomes.

Endometrial scratch injury before intrauterine insemination: is it time to re-evaluate its value? Evidence from a systematic review and meta-analysis of randomized controlled trials.

PubMed

Vitagliano, Amerigo; Noventa, Marco; Saccone, Gabriele; Gizzo, Salvatore; Vitale, Salvatore Giovannni; Laganà, Antonio Simone; Litta, Pietro Salvatore; Saccardi, Carlo; Nardelli, Giovanni Battista; Di Spiezio Sardo, Attilio

2018-01-01

To assess the impact of endometrial scratch injury (ESI) on the outcomes of intrauterine insemination (IUI) stimulated cycles. Systematic review and meta-analysis. Not applicable. Infertile women undergoing one or more IUI stimulated cycles. Randomized controlled trials (RCTs) were identified by searching electronic databases. We included RCTs comparing ESI (i.e., intervention group) during the course of IUI stimulated cycle (C-ESI) or during the menstrual cycle preceding IUI treatment (P-ESI) with controls (no endometrial scratch). The summary measures were reported as odds ratio (OR) with 95% confidence-interval (CI). Clinical pregnancy rate, ongoing pregnancy rate, multiple pregnancy rate, ectopic pregnancy rate, miscarriage rate. Eight trials were included in the meta-analysis, comprising a total of 1,871 IUI cycles. Endometrial scratch injury was associated with a higher clinical pregnancy rate (OR 2.27) and ongoing pregnancy rate (OR 2.04) in comparison with the controls. No higher risk of multiple pregnancy (OR 1.09), miscarriage (OR 0.80), or ectopic pregnancy (OR 0.82) was observed in patients receiving ESI. Subgroup analysis based on ESI timing showed higher clinical pregnancy rate (OR 2.57) and ongoing pregnancy rate (OR 2.27) in patients receiving C-ESI and no advantage in patients receiving P-ESI. Available data suggest that ESI performed once, preferably during the follicular phase of the same cycle of IUI with flexible aspiration catheters, may improve clinical pregnancy and ongoing pregnancy rates in IUI cycles. Endometrial scratch injury does not appear to increase the risk of multiple pregnancy, miscarriage, or ectopic pregnancy. Copyright © 2017 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Assessing Behavioural Manifestations Prior to Clinical Diagnosis of Huntington Disease: "Anger and Irritability" and "Obsessions and Compulsions"

PubMed Central

Vaccarino, Anthony L; Anonymous; Anderson, Karen E.; Borowsky, Beth; Coccaro, Emil; Craufurd, David; Endicott, Jean; Giuliano, Joseph; Groves, Mark; Guttman, Mark; Ho, Aileen K; Kupchak, Peter; Paulsen, Jane S.; Stanford, Matthew S.; van Kammen, Daniel P; Watson, David; Wu, Kevin D; Evans, Ken

2011-01-01

The Functional Rating Scale Taskforce for pre-Huntington Disease (FuRST-pHD) is a multinational, multidisciplinary initiative with the goal of developing a data-driven, comprehensive, psychometrically sound, rating scale for assessing symptoms and functional ability in prodromal and early Huntington disease (HD) gene expansion carriers. The process involves input from numerous sources to identify relevant symptom domains, including HD individuals, caregivers, and experts from a variety of fields, as well as knowledge gained from the analysis of data from ongoing large-scale studies in HD using existing clinical scales. This is an iterative process in which an ongoing series of field tests in prodromal (prHD) and early HD individuals provides the team with data on which to make decisions regarding which questions should undergo further development or testing and which should be excluded. We report here the development and assessment of the first iteration of interview questions aimed to assess "Anger and Irritability" and "Obsessions and Compulsions" in prHD individuals. PMID:21826116

Pain, health-related quality of life and health care utilization after inpatient surgery: A pilot study

PubMed Central

VanDenKerkhof, Elizabeth G; Hopman, Wilma M; Towheed, Tanveer; Wilson, Rosemary; Murdoch, John; Rimmer, Michael; Stutzman, Sherri Schmidt; Tod, Debbie; Dagnone, Vico; Goldstein, David H

2006-01-01

BACKGROUND Little is known about pain-related outcomes in surgical inpatients after discharge from the hospital. An ongoing risk and outcomes monitoring system would provide valuable feedback to improve the quality of patient care. OBJECTIVES The purpose of the present pilot study was to describe postoperative pain, medication use, health care utilization and health-related quality of life (HRQOL) immediately and four weeks after surgery; merge clinically captured data with Web-based follow-up data; and examine patients’ willingness to complete Web-based health questionnaires. METHODS One hundred two consecutive surgical inpatients were approached for participation. Perioperative data were abstracted from the acute pain management service clinical database and linked to follow-up data captured four weeks postoperatively. RESULTS Follow-up questionnaires were completed by 88 participants. Clinical assessment data were successfully linked to Web-based follow-up data. Average pain intensity (3.7) four weeks following discharge fell just short of the acute pain management service active pain score of 3.9. At four weeks, all 88 participants reported significantly impaired HRQOL, 36 were still taking pain medications and 15 had visited an emergency room. Two-thirds of the participants had access to the Internet at home and approximately one-half were willing to complete on-line health questionnaires. DISCUSSION The study indicates that it is feasible to link clinical and research data, and shows a significant burden of pain and reduced HRQOL in the weeks following discharge. This approach to converting clinically captured data into meaningful information about surgical outcomes is valuable in the development of an ongoing risk and outcomes monitoring system. PMID:16511613

An evaluation of the role of the clinical education facilitator.

PubMed

McCormack, Brendan; Slater, Paul

2006-02-01

The objective of the study was to identify whether clinical education facilitators made a difference to the learning experiences of nurses in a large teaching hospital. Strategies for enabling continuous professional development are well established in health care organizations as key components of approaches to lifelong learning. The benefits of continuous professional development include the maintenance of high standards of care, the improvement and development of services, ensuring the competency of all nursing staff and guaranteeing the accountability of nurses for their actions. The role of clinical education facilitator is relatively new and little evaluation of this role has been undertaken. This study highlights important issues to be considered in developing a 'learning culture' in a hospital organization, through the adoption of such roles as clinical education facilitators. Whilst the roles have had an important function in the active coordination of learning activities in the hospital, there is little evidence of the role directly impacting on the learning culture of clinical settings. Learning mechanisms have been identified. The results of this evaluation can be subjected to further testing through ongoing evaluation of the outcomes arising from the learning mechanisms in place. Given the emphasis on work-based learning and continuing professional development in health care, then this ongoing evaluation can yield important information about future directions for nurse education. The study highlights the importance of supported learning in the workplace. However, more importantly, it identifies the need for a culture of professional practice to be developed in order to sustain learning in practice. Classroom-based learning alone, cannot create a culture of development in nursing and there is thus a need for models of work-based learning to be integrated into practice environments.

iMidwife: midwifery students' use of smartphone technology as a mediated educational tool in clinical environments.

PubMed

DeLeo, Annemarie; Geraghty, Sadie

2017-12-18

The increasing use of smartphone technology in health care provides midwifery students with unprecedented access to online resources that facilitates the optimal care of women and supports ongoing learning. A small pilot study was conducted in Western Australia, with 29 undergraduate and postgraduate midwifery students to explore the use of smartphone technology whilst in clinical practice. This study aimed to define the impact of smartphones in clinical decision-making and learning whilst in clinical areas, by midwifery students at the point of care. An online survey was used to collect data. Five consistent themes were identified from the results. Smartphone technology encourages self-directed learning, consolidation of theory, engagement through blended learning, complements online education in clinical practice and is a trend in the future of midwifery curriculum. Smartphones enhance the learning and mobility of supportive resources that consolidate midwifery students' clinical experience in workplace environments.

Circulating tumor cells: clinical validity and utility.

PubMed

Cabel, Luc; Proudhon, Charlotte; Gortais, Hugo; Loirat, Delphine; Coussy, Florence; Pierga, Jean-Yves; Bidard, François-Clément

2017-06-01

Circulating tumor cells (CTCs) are rare tumor cells and have been investigated as diagnostic, prognostic and predictive biomarkers in many types of cancer. Although CTCs are not currently used in clinical practice, CTC studies have accumulated a high level of clinical validity, especially in breast, lung, prostate and colorectal cancers. In this review, we present an overview of the current clinical validity of CTCs in metastatic and non-metastatic disease, and the main concepts and studies investigating the clinical utility of CTCs. In particular, this review will focus on breast, lung, colorectal and prostate cancer. Three major topics concerning the clinical utility of CTC are discussed-(1) treatment based on CTCs used as liquid biopsy, (2) treatment based on CTC count or CTC variations, and (3) treatment based on CTC biomarker expression. A summary of published or ongoing phase II and III trials is also presented.

An e-mail survey identified unpublished studies for systematic reviews.

PubMed

Reveiz, Ludovic; Cardona, Andres Felipe; Ospina, Edgar Guillermo; de Agular, Sylvia

2006-07-01

A large number of trials remain difficult to locate or unpublished for systematic reviews. The objective of this article was to determine the usefulness of making e-mail contact with authors of clinical trials and literature reviews found in MEDLINE to identify unpublished or difficult to locate Randomized Controlled Trials (RCTs). A structured search for detecting RCTs in MEDLINE was made from January 1999 to June 2003; a questionnaire was sent to a random sample of 525 author's mails. Those RCTs obtained were sought in MEDLINE, EMBASE, the Cochrane Controlled Trials Register, LILACS, and ongoing registers. 40 (7.6%) replies were received; 10 previously undescribed and unpublished RCTs and 21 unregistered ongoing RCTs were found. The most frequently given reasons for not publishing were: lack of time for finalizing the statistical analysis and preparing the manuscript, contractual obligations with the pharmaceutical industry, methodologic errors in designing, and editorial rejection. Using the e-mails of authors detected by the search in electronic databases could contribute toward detecting potentially relevant ongoing or unpublished RCTs enabling rapid, straightforward, low-cost systematic review; in addition, the results of this study support the need of universal registration of all studies at their inception.

Harvard Aging Brain Study: Dataset and accessibility.

PubMed

Dagley, Alexander; LaPoint, Molly; Huijbers, Willem; Hedden, Trey; McLaren, Donald G; Chatwal, Jasmeer P; Papp, Kathryn V; Amariglio, Rebecca E; Blacker, Deborah; Rentz, Dorene M; Johnson, Keith A; Sperling, Reisa A; Schultz, Aaron P

2017-01-01

The Harvard Aging Brain Study is sharing its data with the global research community. The longitudinal dataset consists of a 284-subject cohort with the following modalities acquired: demographics, clinical assessment, comprehensive neuropsychological testing, clinical biomarkers, and neuroimaging. To promote more extensive analyses, imaging data was designed to be compatible with other publicly available datasets. A cloud-based system enables access to interested researchers with blinded data available contingent upon completion of a data usage agreement and administrative approval. Data collection is ongoing and currently in its fifth year. Copyright © 2015 Elsevier Inc. All rights reserved.

Advanced musculoskeletal physiotherapists in post arthroplasty review clinics: a state wide implementation program evaluation.

PubMed

Harding, Paula; Burge, Angela; Walter, Kerrie; Shaw, Bridget; Page, Carolyn; Phan, Uyen; Terrill, Desiree; Liew, Susan

2018-03-01

To evaluate outcomes following a state-wide implementation of post arthroplasty review (PAR) clinics for patients following total hip and knee arthroplasty, led by advanced musculoskeletal physiotherapists in collaboration with orthopaedic specialists. A prospective observational study analysed data collected by 10 implementation sites (five metropolitan and five regional/rural centres) between September 2014 and June 2015. The Victorian Innovation and Reform Impact Assessment Framework was used to assess efficiency, effectiveness (access to care, safety and quality, workforce capacity, utilisation of skill sets, patient and workforce satisfaction) and sustainability (stakeholder engagement, succession planning and availability of ongoing funding). 2362 planned occasions of service (OOS) were provided for 2057 patients. Reduced patient wait times from referral to appointment were recorded and no adverse events occurred. Average cost savings across 10 sites was AUD$38 per OOS (Baseline $63, PAR clinic $35), representing a reduced pathway cost of 44%. Average annual predicted total value of increased orthopaedic specialist capacity was $11,950 per PAR clinic (range $6149 to $23,400). The Australian Orthopaedic Association review guidelines were met (8/10 sites, 80%) and patient-reported outcome measures were introduced as routine clinical care. High workforce and patient satisfaction were expressed. Eighteen physiotherapists were trained creating a sustainable workforce. Eight sites secured ongoing funding. The PAR clinics delivered a safe, cost-efficient model of care that improved patient access and quality of care compared to traditional specialist-led workforce models. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

The role of autologous hematopoietic progenitor and cell reinfusion for intensive chemotherapy in women with poor-prognosis breast cancer. Clinical studies with ex-vivo expanded cells produced with the Aastrom Replicell technology.

PubMed

Chabannon, C; Novakovitch, G; Blache, J L; Olivero, S; Camerlo, J; Genre, D; Maraninchi, D; Viens, P

1999-04-01

In recent years, we have initiated two clinical studies, to evaluate the usefulness of ex-vivo expanded cells in patients with breast cancer who receive sequential high-dose chemotherapy. Ex-vivo expanded cells were produced from autologous cryopreserved bone marrow nucleated cells, using a biomedical device. The Aastrom Replicell system cultures cells in animal serum-replete medium, with a combination of flt3-L, PIXY321 and Epo, for 12 days. The initial pilot trial was set up to establish the feasibility and safety of the technique: 6 patients completed the study. An ongoing randomized study searches to establish whether ex-vivo expanded cells provide a clinical benefit.

Polysaccharide‐Based Controlled Release Systems for Therapeutics Delivery and Tissue Engineering: From Bench to Bedside

PubMed Central

Miao, Tianxin; Wang, Junqing; Zeng, Yun; Chen, Xiaoyuan

2018-01-01

Abstract Polysaccharides or polymeric carbohydrate molecules are long chains of monosaccharides that are linked by glycosidic bonds. The naturally based structural materials are widely applied in biomedical applications. This article covers four different types of polysaccharides (i.e., alginate, chitosan, hyaluronic acid, and dextran) and emphasizes their chemical modification, preparation approaches, preclinical studies, and clinical translations. Different cargo fabrication techniques are also presented in the third section. Recent progresses in preclinical applications are then discussed, including tissue engineering and treatment of diseases in both therapeutic and monitoring aspects. Finally, clinical translational studies with ongoing clinical trials are summarized and reviewed. The promise of new development in nanotechnology and polysaccharide chemistry helps clinical translation of polysaccharide‐based drug delivery systems. PMID:29721408

An Ongoing Randomized Clinical Trial in Dysphagia

ERIC Educational Resources Information Center

Robbins, JoAnne; Hind, Jackie; Logemann, Jerilyn

2004-01-01

Most of us who have clinical practices firmly contend that the treatments we provide cause beneficial changes in the lives of our patients. Indeed, our clinical experience engenders strong convictions to the point of believing that withholding treatment creates ethical violations. Intellectually, however, we must recognize that the value of…

Digital Breast Tomosynthesis: State of the Art

PubMed Central

Vedantham, Srinivasan; Vijayaraghavan, Gopal R.; Kopans, Daniel B.

2015-01-01

This topical review on digital breast tomosynthesis (DBT) is provided with the intent of describing the state of the art in terms of technology, results from recent clinical studies, advanced applications, and ongoing efforts to develop multimodality imaging systems that include DBT. Particular emphasis is placed on clinical studies. The observations of increase in cancer detection rates, particularly for invasive cancers, and the reduction in false-positive rates with DBT in prospective trials indicate its benefit for breast cancer screening. Retrospective multireader multicase studies show either noninferiority or superiority of DBT compared with mammography. Methods to curtail radiation dose are of importance. © RSNA, 2015 PMID:26599926

Biology and therapy of fibromyalgia. Evidence-based biomarkers for fibromyalgia syndrome

PubMed Central

Dadabhoy, Dina; Crofford, Leslie J; Spaeth, Michael; Russell, I Jon; Clauw, Daniel J

2008-01-01

Researchers studying fibromyalgia strive to identify objective, measurable biomarkers that may identify susceptible individuals, may facilitate diagnosis, or that parallel activity of the disease. Candidate objective measures range from sophisticated functional neuroimaging to office-ready measures of the pressure pain threshold. A systematic literature review was completed to assess highly investigated, objective measures used in fibromyalgia studies. To date, only experimental pain testing has been shown to coincide with improvements in clinical status in a longitudinal study. Concerted efforts to systematically evaluate additional objective measures in research trials will be vital for ongoing progress in outcome research and translation into clinical practice. PMID:18768089

Do Research Intermediaries Reduce Perceived Coercion to Enter Research Trials Among Criminally Involved Substance Abusers?

PubMed

Festinger, David S; Dugosh, Karen L; Croft, Jason R; Arabia, Patricia L; Marlowe, Douglas B

2011-01-01

We examined the efficacy of including a research intermediary (RI) during the consent process in reducing participants' perceptions of coercion to enroll in a research study. Eighty-four drug court clients being recruited into an ongoing study were randomized to receive a standard informed consent process alone (standard condition) or with an RI (intermediary condition). Before obtaining consent, RIs met with clients individually to discuss remaining concerns. Findings provided preliminary evidence that RIs reduced client perceptions that their participation might influence how clinical and judicial staff view them. This suggests that using RIs may improve participant autonomy in clinical studies.

Do Research Intermediaries Reduce Perceived Coercion to Enter Research Trials Among Criminally Involved Substance Abusers?

PubMed Central

Festinger, David S.; Dugosh, Karen L.; Croft, Jason R.; Arabia, Patricia L.; Marlowe, Douglas B.

2011-01-01

We examined the efficacy of including a research intermediary (RI) during the consent process in reducing participants’ perceptions of coercion to enroll in a research study. Eighty-four drug court clients being recruited into an ongoing study were randomized to receive a standard informed consent process alone (standard condition) or with an RI (intermediary condition). Before obtaining consent, RIs met with clients individually to discuss remaining concerns. Findings provided preliminary evidence that RIs reduced client perceptions that their participation might influence how clinical and judicial staff view them. This suggests that using RIs may improve participant autonomy in clinical studies. PMID:22081751

Qualitative evaluation of suicide and overdose risk assessment procedures among veterans in substance use disorder treatment clinics.

PubMed

Webster, Linda; Eisenberg, Anna; Bohnert, Amy S B; Kleinberg, Felicia; Ilgen, Mark A

2012-01-01

The objective of this study was to examine risk assessment practices for suicide and unintentional overdose to inform ongoing care in substance use disorder clinics. Focus groups were conducted via telephone among a random sample of treatment providers (N = 19) from Veterans Health Administration substance use disorder clinics across the nation. Themes were coded by research staff. Treatment providers reported consistent and clear guidelines for risk assessment of suicide among patients. Unintentional overdose questions elicited dissimilar responses which indicated a lack of cohesion and uniformity in risk assessment practices across clinics. Suicide risk assessment protocols are cohesively implemented by treatment providers. Unintentional overdose risk, however, may be less consistently assessed in clinics.

Augmentation of light therapy in difficult-to-treat depressed patients: an open-label trial in both unipolar and bipolar patients

PubMed Central

Camardese, Giovanni; Leone, Beniamino; Serrani, Riccardo; Walstra, Coco; Di Nicola, Marco; Della Marca, Giacomo; Bria, Pietro; Janiri, Luigi

2015-01-01

Objectives We investigated the clinical benefits of bright light therapy (BLT) as an adjunct treatment to ongoing psychopharmacotherapy, both in unipolar and bipolar difficult-to-treat depressed (DTD) outpatients. Methods In an open-label study, 31 depressed outpatients (16 unipolar and 15 bipolar) were included to undergo 3 weeks of BLT. Twenty-five completed the treatment and 5-week follow-up. Main outcome measures Clinical outcomes were evaluated by the Hamilton Depression Rating Scale (HDRS). The Snaith–Hamilton Pleasure Scale and the Depression Retardation Rating Scale were used to assess changes in anhedonia and psychomotor retardation, respectively. Results The adjunctive BLT seemed to influence the course of the depressive episode, and a statistically significant reduction in HDRS scores was reported since the first week of therapy. The treatment was well-tolerated, and no patients presented clinical signs of (hypo)manic switch during the overall treatment period. At the end of the study (after 5 weeks from BLT discontinuation), nine patients (36%, eight unipolar and one bipolar) still showed a treatment response. BLT augmentation also led to a significant improvement of psychomotor retardation. Conclusion BLT combined with the ongoing pharmacological treatment offers a simple approach, and it might be effective in rapidly ameliorating depressive core symptoms of vulnerable DTD outpatients. These preliminary results need to be confirmed in placebo-controlled, randomized, double-blind clinical trial on larger samples. PMID:26396517

WE-G-217BCD-04: Diagnostic Image Quality Evaluation of a Dedicated Extremity Cone- Beam CT Scanner: Pre-Clinical Studies and First Clinical Results.

PubMed

Muhit, A; Zbijewski, W; Stayman, J; Thawait, G; Yorkston, J; Foos, D; Packard, N; Yang, D; Senn, R; Carrino, J; Siewerdsen, J

2012-06-01

To assess the diagnostic performance of a prototype cone-beam CT (CBCT) scanner developed for musculoskeletal extremity imaging. Studies involved controlled observer studies conducted subsequent to rigorous technical assessment as well as patient images from the first clinical trial in imaging the hand and knee. Performance assessment included: 1.) rigorous technical assessment; 2.) controlled observer studies using CBCT images of cadaveric specimens; and 3.) first clinical images. Technical assessment included measurement of spatial resolution (MTF), constrast, and noise (SDNR) versus kVp and dose using standard CT phantoms. Diagnostic performance in comparison to multi- detector CT (MDCT) was assessed in controlled observer studies involving 12 cadaveric hands and knees scanned with and without abnormality (fracture). Observer studies involved five radiologists rating pertinent diagnostics tasks in 9-point preference and 10-point diagnostic satisfaction scales. Finally, the first clinical images from an ongoing pilot study were assessed in terms of diagnostic utility in disease assessment and overall workflow in patient setup. Quantitative assessment demonstrated sub-mm spatial resolution (MTF exceeding 10% out to 15-20 cm-1) and SDNR sufficient for relevant soft-tissue visualization tasks at dose <10 mGy. Observer studies confirmed optimal acquisition techniques and demonstrated superior utility of combined soft-tissue visualization and isotropic spatial resolution in diagnostic tasks. Images from the patient trial demonstrate exquisite contrast and detail and the ability to detect tissue impingement in weight-bearing exams. The prototype CBCT scanner provides isotropic spatial resolution superior to standard-protocol MDCT with soft-tissue visibility sufficient for a broad range of diagnostic tasks in musculoskeletal radiology. Dosimetry and workflow were advantageous in comparison to whole-body MDCT. Multi-mode and weight-bearing capabilities add valuable functionality. An ongoing clinical study further assesses diagnostic utility and defines the role of such technology in the diagnostic arsenal. - Research Grant, Carestream Health - Research Grant, National Institutes of Health 2R01-CA-112163. © 2012 American Association of Physicists in Medicine.

Opinions and practices of healthcare professionals on assessment of disease associated malnutrition in children: Results from an international survey.

PubMed

Huysentruyt, Koen; Hulst, Jessie; Bian, Feifei; Shamir, Raanan; White, Melinda; Galera-Martinez, Raphael; Morais-Lopez, Anna; Kansu, Aydan; Gerasimidis, Konstantinos

2018-04-05

Lack of consensus on clinical indicators for the assessment of pediatric disease associated malnutrition (DAM) may explain its under-recognition in clinical practice. This study surveyed the opinions of health professionals (HP) on clinical indicators of DAM and barriers impeding routine nutritional screening in children. Web-based questionnaire survey (April 2013-August 2015) in Australia, Belgium, Israel, Spain, The Netherlands, Turkey and UK. There were 937 questionnaires returned via local professional associations, of which 693 respondents fulfilled the inclusion criteria and were included in the final analysis; 315 pediatric gastroenterologists and 378 pediatric dieticians. The most important clinical indicators of DAM were ongoing weight loss (80.4%), increased energy/nutrient losses (73.0%), suboptimal energy/macronutrient intake (68.6%), a high nutritional risk condition (67.2%) and increased energy/nutrient requirements (66.2%). These findings were consistent across countries and professions. The most common approach to screen for DAM was assessment of weight changes (85%), followed by the usage of growth charts (77-80%). Common perceived barriers for routine nutritional screening/assessment were low staff awareness (47.5%), no local policy or guidelines (33.4%) and lack of time to screen (33.4%). HP who routinely assess and treat children with DAM identified ongoing weight loss, increased losses, increased requirements, low intake and high nutritional risk conditions as the most important clinical indicators of DAM. These clinical indicators should now serve as a basis to form clinical-based criteria for the identification of DAM in routine clinical practice. Low awareness, lack of guidelines or local policy and lack of resources were the most important barriers of routine screening. Copyright © 2018 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Review of ongoing clinical trials in non-small-cell lung cancer: a status report for 2012 from the ClinicalTrials.gov Web site.

PubMed

Subramanian, Janakiraman; Regenbogen, Thomas; Nagaraj, Gayathri; Lane, Alex; Devarakonda, Siddhartha; Zhou, Gongfu; Govindan, Ramaswamy

2013-07-01

Clinical research in non-small-cell lung cancer (NSCLC) is a rapidly evolving field. In an effort to identify the current trends in lung cancer clinical research, we reviewed ongoing clinical trials in NSCLC listed in the ClinicalTrials.gov registry in 2012, and we also compared this data to a similar survey conducted by us in 2009. The Web site's advanced search function was used to search for the term "non-small cell lung cancer." The search was further refined by using the following options from the search page drop-down menu, "open studies" and "interventional." Studies with non-NSCLC tumor histologies and pediatric studies were excluded. Of the 477 trials included in the analysis, 105 (22.0%) were phase I, 223 phase II (46.8%), and 63 phase III trials (13.2%). When compared with data from 2009, university-sponsored trials decreased in number (45.4%-34.2%; p < 0.001) whereas industry-sponsored trials remained almost the same. There was a significant increase in trials conducted exclusively outside of the United States (35.9%-48.8%; p = 0.001). The number of studies with locations in China (61, 12.8%) was second only to that in the United States (244, 51.2%). Studies reporting biomarker analysis increased significantly from 37.5% to 49.1% in 2012 (p < 0.001). Biomarker-based patient selection also increased significantly from 7.9% to 25.8% (p < 0.001). Targeted therapies were evaluated in 70.6% of phase I/II and II trials, and the most common class of targeted agent studied was epidermal growth factor receptor tyrosine kinase inhibitors (38.0%). Prespecified accrual times were observed to increase when compared with data reported in 2009, especially among industry-sponsored studies. Our survey identified major changes in lung cancer clinical research since 2009. Almost half of all studies registered at the ClinicalTrials.gov Web site are being conducted outside the United States, and several novel molecularly targeted agents are being evaluated in the treatment of patients with NSCLC. More importantly, we identified a threefold increase in the number of studies that perform biomarker testing to determine patient selection over the last 3 years.

Clinical Investigation Program Report Control Symbol MED 300.

DTIC Science & Technology

1983-10-01

13 Agent Induced Delay of Gastric Emptying. (0) (PR) (P) 1979 The Experimental Fat Embolism Syndrome: An Electron 15 Microscopic Study of Lung in...1981 Investigation of Chronic Phantom Pain. (0) (PR) (P) 25 v Year Page Initiated 1981 Experimental Fat Embolism Syndrome: Basic Studies and 26...14 Detail Summary Sheet Date 3 Oct 83 Prot No.: 79-21 Status: Ongoing Title: The Experimental Fat Embolism Syndrome: An Electron Microscopic Study of

Transcatheter Aortic Valve Implantation: Experience with the CoreValve Device.

PubMed

Asgar, Anita W; Bonan, Raoul

2012-01-01

The field of transcatheter aortic valve implantation has been rapidly evolving. The Medtronic CoreValve first emerged on the landscape in 2004 with initial first human studies, and it is currently being studied in the Pivotal US trial. This article details the current experience with the self-expanding aortic valve with a focus on clinical results and ongoing challenges. Copyright © 2012 Elsevier Inc. All rights reserved.

Prevention of the Post-traumatic Fibrotic Response in Joints

DTIC Science & Technology

2014-10-01

JJ, Wolman M. Aging of wound healing in an experimental model in mice. The American journal of forensic medicine and pathology . 1988; 9(4):310-2...SUPPLEMENTARY NOTES 14. ABSTRACT The ongoing study addresses the critical clinical problem of posttraumatic joint stiffness, a pathology that reduces...study is that pathological fibrotic response of injured joint tissues may be limited by targeting the formation of collagen fibrils, a main component

Clinical trials in "emerging markets": regulatory considerations and other factors.

PubMed

Singh, Romi; Wang, Ouhong

2013-11-01

Clinical studies are being placed in emerging markets as part of global drug development programs to access large pool of eligible patients and to benefit from a cost effective structure. However, over the last few years, the definition of "emerging markets" is being revisited, especially from a regulatory perspective. For purposes of this article, countries outside US, EU and the traditional "western countries" are discussed. Multiple factors are considered for placement of clinical studies such as adherence to Good Clinical Practice (GCP), medical infrastructure & standard of care, number of eligible patients, etc. This article also discusses other quantitative factors such as country's GDP, patent applications, healthcare expenditure, healthcare infrastructure, corruption, innovation, etc. These different factors and indexes are correlated to the number of clinical studies ongoing in the "emerging markets". R&D, healthcare expenditure, technology infrastructure, transparency, and level of innovation, show a significant correlation with the number of clinical trials being conducted in these countries. This is the first analysis of its kind to evaluate and correlate the various other factors to the number of clinical studies in a country. © 2013.

Current Status and Future Development of Cell Transplantation Therapy for Periodontal Tissue Regeneration

PubMed Central

Yoshida, Toshiyuki; Washio, Kaoru; Iwata, Takanori; Okano, Teruo; Ishikawa, Isao

2012-01-01

It has been shown that stem cell transplantation can regenerate periodontal tissue, and several clinical trials involving transplantation of stem cells into human patients have already begun or are in preparation. However, stem cell transplantation therapy is a new technology, and the events following transplantation are poorly understood. Several studies have reported side effects and potential risks associated with stem cell transplantation therapy. To protect patients from such risks, governments have placed regulations on stem cell transplantation therapies. It is important for the clinicians to understand the relevant risks and governmental regulations. This paper describes the ongoing clinical studies, basic research, risks, and governmental controls related to stem cell transplantation therapy. Then, one clinical study is introduced as an example of a government-approved periodontal cell transplantation therapy. PMID:22315604

Mind how you cross the gap! Outcomes for young people who failed to make the transition from child to adult services: the TRACK study

PubMed Central

Islam, Zoebia; Ford, Tamsin; Kramer, Tami; Paul, Moli; Parsons, Helen; Harley, Katherine; Weaver, Tim; McLaren, Susan; Singh, Swaran P.

2016-01-01

Aims and method The Transitions of Care from Child and Adolescent Mental Health Services to Adult Mental Health Services (TRACK) study was a multistage, multicentre study of adolescents' transitions between child and adult mental health services undertaken in England. We conducted a secondary analysis of the TRACK study data to investigate healthcare provision for young people (n = 64) with ongoing mental health needs, who were not transferred from child and adolescent mental health services (CAMHS) to adult mental health services mental health services (AMHS). Results The most common outcomes were discharge to a general practitioner (GP; n = 29) and ongoing care with CAMHS (n = 13), with little indication of use of third-sector organisations. Most of these young people had emotional/neurotic disorders (n = 31, 48.4%) and neurodevelopmental disorders (n = 15, 23.4%). Clinical implications GPs and CAMHS are left with the responsibility for the continuing care of young people for whom no adult mental health service could be identified. GPs may not be able to offer the skilled ongoing care that these young people need. Equally, the inability to move them decreases the capacity of CAMHS to respond to new referrals and may leave some young people with only minimal support. PMID:27280035

Mind how you cross the gap! Outcomes for young people who failed to make the transition from child to adult services: the TRACK study.

PubMed

Islam, Zoebia; Ford, Tamsin; Kramer, Tami; Paul, Moli; Parsons, Helen; Harley, Katherine; Weaver, Tim; McLaren, Susan; Singh, Swaran P

2016-06-01

Aims and method The Transitions of Care from Child and Adolescent Mental Health Services to Adult Mental Health Services (TRACK) study was a multistage, multicentre study of adolescents' transitions between child and adult mental health services undertaken in England. We conducted a secondary analysis of the TRACK study data to investigate healthcare provision for young people (n = 64) with ongoing mental health needs, who were not transferred from child and adolescent mental health services (CAMHS) to adult mental health services mental health services (AMHS). Results The most common outcomes were discharge to a general practitioner (GP; n = 29) and ongoing care with CAMHS (n = 13), with little indication of use of third-sector organisations. Most of these young people had emotional/neurotic disorders (n = 31, 48.4%) and neurodevelopmental disorders (n = 15, 23.4%). Clinical implications GPs and CAMHS are left with the responsibility for the continuing care of young people for whom no adult mental health service could be identified. GPs may not be able to offer the skilled ongoing care that these young people need. Equally, the inability to move them decreases the capacity of CAMHS to respond to new referrals and may leave some young people with only minimal support.

Blood pressure control in resistant hypertension: new therapeutic options.

PubMed

Grassi, Guido; Quarti-Trevano, Fosca; Brambilla, Gianmaria; Seravalle, Gino

2010-11-01

Resistant hypertension, namely the hypertensive state characterized by the inability of multiple antihypertensive drug interventions to lower blood pressure to goal levels, represents a condition frequently detected in clinical practice. Its main features are represented by its heterogeneous etiology as well as its very high cardiovascular risk. This latter peculiarity has implemented the research for new approaches to the treatment of the disease. This article will focus on two of them, namely carotid baroreceptor electric stimulation and the renal denervation procedure. Clinical studies and large-scale clinical trials are presently ongoing with the aim of defining the long-term efficacy and safety profile of the two interventions.

Precision medicine in pediatric oncology: Lessons learned and next steps.

PubMed

Mody, Rajen J; Prensner, John R; Everett, Jessica; Parsons, D Williams; Chinnaiyan, Arul M

2017-03-01

The maturation of genomic technologies has enabled new discoveries in disease pathogenesis as well as new approaches to patient care. In pediatric oncology, patients may now receive individualized genomic analysis to identify molecular aberrations of relevance for diagnosis and/or treatment. In this context, several recent clinical studies have begun to explore the feasibility and utility of genomics-driven precision medicine. Here, we review the major developments in this field, discuss current limitations, and explore aspects of the clinical implementation of precision medicine, which lack consensus. Lastly, we discuss ongoing scientific efforts in this arena, which may yield future clinical applications. © 2016 Wiley Periodicals, Inc.

Precision medicine in pediatric oncology: Lessons learned and next steps

PubMed Central

Mody, Rajen J.; Prensner, John R.; Everett, Jessica; Parsons, D. Williams; Chinnaiyan, Arul M.

2017-01-01

The maturation of genomic technologies has enabled new discoveries in disease pathogenesis as well as new approaches to patient care. In pediatric oncology, patients may now receive individualized genomic analysis to identify molecular aberrations of relevance for diagnosis and/or treatment. In this context, several recent clinical studies have begun to explore the feasibility and utility of genomics-driven precision medicine. Here, we review the major developments in this field, discuss current limitations, and explore aspects of the clinical implementation of precision medicine, which lack consensus. Lastly, we discuss ongoing scientific efforts in this arena, which may yield future clinical applications. PMID:27748023

Another Piece of the Antibody Puzzle: Observations from the HALT study\\.

PubMed

Snyder, Laurie D; Tinckam, Kathryn J

2018-06-04

In the rapidly evolving domain of clinical transplantation immunobiology, the interrogation and interpretation of HLA antibodies and their associated clinical consequences are in the spotlight. In lung transplant, HLA antibodies, in particular donor specific antibodies (DSA), are a determining component of the lung transplant antibody mediated rejection (AMR) definition (1). DSA after lung transplant are widely regarded as poor prognosticator, though sparse data to date necessitate ongoing discourse and continued investigation into incidence, timing and treatment. Prior studies reported a wide range of DSA incidence with differing consequences on a background of highly variable timing, methods, antibody analytic strategies and clinical definitions. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

21 CFR 56.121 - Disqualification of an IRB or an institution.

Code of Federal Regulations, 2010 CFR

2010-04-01

... will not approve an application for a research permit for a clinical investigation that is to be under... the rights or welfare of the human subjects in a clinical investigation. (c) If the Commissioner... for the determination and that prescribes any actions to be taken with regard to ongoing clinical...

Brain Functional Changes before, during, and after Clinical Pain.

PubMed

Hu, X; Racek, A J; Bellile, E; Nascimento, T D; Bender, M C; Toback, R L; Burnett, D; Khatib, L; McMahan, R; Kovelman, I; Ellwood, R P; DaSilva, A F

2018-05-01

This study used an emerging brain imaging technique, functional near-infrared spectroscopy (fNIRS), to investigate functional brain activation and connectivity that modulates sometimes traumatic pain experience in a clinical setting. Hemodynamic responses were recorded at bilateral somatosensory (S1) and prefrontal cortices (PFCs) from 12 patients with dentin hypersensitivity in a dental chair before, during, and after clinical pain. Clinical dental pain was triggered with 20 consecutive descending cold stimulations (32° to 0°C) to the affected teeth. We used a partial least squares path modeling framework to link patients' clinical pain experience with recorded hemodynamic responses at sequential stages and baseline resting-state functional connectivity (RSFC). Hemodynamic responses at PFC/S1 were sequentially elicited by expectation, cold detection, and pain perception at a high-level coefficient (coefficients: 0.92, 0.98, and 0.99, P < 0.05). We found that the pain ratings were positively affected only at a moderate level of coefficients by such sequence of functional activation (coefficient: 0.52, P < 0.05) and the baseline PFC-S1 RSFC (coefficient: 0.59, P < 0.05). Furthermore, when the dental pain had finally subsided, the PFC increased its functional connection with the affected S1 orofacial region contralateral to the pain stimulus and, in contrast, decreased with the ipsilateral homuncular S1 regions ( P < 0.05). Our study indicated for the first time that patients' clinical pain experience in the dental chair can be predicted concomitantly by their baseline functional connectivity between S1 and PFC, as well as their sequence of ongoing hemodynamic responses. In addition, this linked cascade of events had immediate after-effects on the patients' brain connectivity, even when clinical pain had already ceased. Our findings offer a better understating of the ongoing impact of affective and sensory experience in the brain before, during, and after clinical dental pain.

A portable 12-wavelength parallel near-infrared spectral tomography (NIRST) system for efficient characterization of breast cancer during neoadjuvant chemotherapy

NASA Astrophysics Data System (ADS)

Zhao, Yan; Burger, William R.; Zhou, Mingwei; Pogue, Brian W.; Paulsen, Keith D.; Jiang, Shudong

2017-02-01

A portable, 12-wavelength hybrid frequency domain (FD) and continuous wave (CW) near-infrared spectral tomography (NIRST) system was developed for efficient characterization of breast cancer in a clinical oncology setting. Two sets of three FD and three CW measurements were acquired simultaneously. The imaging time was reduced from 90 to 55 seconds with a new gain adjustment scheme of the optical detector. The study of integrating this system into the workflow of clinical oncology practice is ongoing.

INVESTIGATING THE EFFICACY OF CLINICAL TRIAL MONITORING STRATEGIES: Design and Implementation of the Cluster Randomized START Monitoring Substudy

PubMed Central

Hullsiek, Katherine Huppler; Kagan, Jonathan M; Engen, Nicole; Grarup, Jesper; Hudson, Fleur; Denning, Eileen T; Carey, Catherine; Courtney-Rodgers, David; Finley, Elizabeth B; Jansson, Per O; Pearson, Mary T; Peavy, Dwight E; Belloso, Waldo H

2014-01-01

Background Trial monitoring protects participant safety and study integrity. While monitors commonly go on-site to verify source data, there is little evidence that this practice is efficient or effective. An ongoing international HIV treatment trial (START) provides an opportunity to explore the usefulness of different monitoring approaches. Methods All START sites are centrally monitored and required to follow a local monitoring plan requiring specific quality assurance activities. Additionally, sites were randomized (1:1) to receive, or not receive, annual on-site monitoring. The study will determine if on-site monitoring increases the identification of major protocol deviations (eligibility or consent violations, improper study drug use, primary or serious event underreporting, data alteration or fraud). Results The START study completed enrollment in December 2013, with planned follow-up through December 2016. The monitoring study is ongoing at 196 sites in 34 countries. Results are expected when the START study concludes in December 2016. PMID:25973346

Blastocyst culture using single versus sequential media in clinical IVF: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Sfontouris, Ioannis A; Martins, Wellington P; Nastri, Carolina O; Viana, Iara G R; Navarro, Paula A; Raine-Fenning, Nick; van der Poel, Sheryl; Rienzi, Laura; Racowsky, Catherine

2016-10-01

The purpose of this study was to undertake a review of the available evidence comparing the use of a single medium versus sequential media for embryo culture to the blastocyst stage in clinical IVF. We searched the Cochrane Central, PubMed, Scopus, ClinicalTrials.gov, Current Controlled Trials and WHO International Clinical Trials Registry Platform to identify randomized controlled trials comparing single versus sequential media for blastocyst culture and ongoing pregnancy rate. Included studies randomized either oocytes/zygotes or women. Eligible oocyte/zygote studies were analyzed to assess the risk difference (RD) and 95 % confidence intervals (CI) between the two media systems; eligible woman-based studies were analyzed to assess the risk ratio (RR) and 95 % CI for clinical pregnancy rate. No differences were observed between single and sequential media for either ongoing pregnancy per randomized woman (relative risk (RR) = 0.9, 95 % CI = 0.7 to 1.3, two studies including 246 women, I 2  = 0 %) or clinical pregnancy per randomized woman (RR = 1.0, 95 % CI = 0.7 to 1.4, one study including 100 women); or miscarriage per clinical pregnancy: RR = 1.3, 95 % CI = 0.4 to 4.3, two studies including 246 participants, I 2  = 0 %). Single media use was associated with an increase blastocyst formation per randomized oocyte/zygote (relative distribution (RD) = +0.06, 95 % CI = +0.01 to +0.12, ten studies including 7455 oocytes/zygotes, I 2  = 83 %) but not top/high blastocyst formation (RD = +0.05, 95 % CI = -0.01 to +0.11, five studies including 3879 oocytes/zygotes, I 2  = 93 %). The overall quality of the evidence was very low for all these four outcomes. Although using a single medium for extended culture has some practical advantages and blastocyst formation rates appear to be higher, there is insufficient evidence to recommend either sequential or single-step media as being superior for the culture of embryos to days 5/6. Future studies comparing these two media systems in well-designed trials should be performed.

76 FR 20359 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-12

... Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; PA10-067: Stem Cells and Diabetic Skin... Major Ongoing Clinical Research Studies in CKD (R01). Date: May 17, 2011. Time: 2 p.m. to 3:30 p.m... . (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research...

Sexual side effects of antidepressant drugs.

PubMed

Gelenberg, A J; Delgado, P; Nurnberg, H G

2000-06-01

Sexual functioning often suffers during depression, although depressed people continue to value sex. Many popular antidepressants further impair sexual functioning, with highly serotonergic agents affecting orgasm and libido prominently. This paper addresses clinical assessment of sexual side effects from antidepressant drugs and reviews treatment strategies, including purported antidotes. We pay particular attention to sildenafil, on which there are impressive data and ongoing controlled studies.

Exclusion of patients with concomitant chronic conditions in ongoing randomised controlled trials targeting 10 common chronic conditions and registered at ClinicalTrials.gov: a systematic review of registration details.

PubMed

Buffel du Vaure, Céline; Dechartres, Agnès; Battin, Constance; Ravaud, Philippe; Boutron, Isabelle

2016-09-27

To systematically assess registration details of ongoing randomised controlled trials (RCTs) targeting 10 common chronic conditions and registered at ClinicalTrials.gov and to determine the prevalence of (1) trial records excluding patients with concomitant chronic condition(s) and (2) those specifically targeting patients with concomitant chronic conditions. Systematic review of trial registration records. ClinicalTrials.gov register. All ongoing RCTs registered from 1 January 2014 to 31 January 2015 that assessed an intervention targeting adults with coronary heart disease (CHD), hypertension, heart failure, stroke/transient ischaemic attack, atrial fibrillation, type 2 diabetes, chronic obstructive pulmonary disease, painful condition, depression and dementia with a target sample size ≥100. From the trial registration records, 2 researchers independently recorded the trial characteristics and the number of exclusion criteria and determined whether patients with concomitant chronic conditions were excluded or specifically targeted. Among 319 ongoing RCTs, despite the high prevalence of the concomitant chronic conditions, patients with these conditions were excluded in 251 trials (79%). For example, although 91% of patients with CHD had a concomitant chronic condition, 69% of trials targeting such patients excluded patients with concomitant chronic condition(s). When considering the co-occurrence of 2 chronic conditions, 31% of patients with chronic pain also had depression, but 58% of the trials targeting patients with chronic pain excluded patients with depression. Only 37 trials (12%) assessed interventions specifically targeting patients with concomitant chronic conditions; 31 (84%) excluded patients with concomitant chronic condition(s). Despite widespread multimorbidity, more than three-quarters of ongoing trials assessing interventions for patients with chronic conditions excluded patients with concomitant chronic conditions. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Profiling biomarkers of traumatic axonal injury: From mouse to man.

PubMed

Manivannan, Susruta; Makwana, Milan; Ahmed, Aminul Islam; Zaben, Malik

2018-05-18

Traumatic brain injury (TBI) poses a major public health problem on a global scale. Its burden results from high mortality and significant morbidity in survivors. This stems, in part, from an ongoing inadequacy in diagnostic and prognostic indicators despite significant technological advances. Traumatic axonal injury (TAI) is a key driver of the ongoing pathological process following TBI, causing chronic neurological deficits and disability. The science underpinning biomarkers of TAI has been a subject of many reviews in recent literature. However, in this review we provide a comprehensive account of biomarkers from animal models to clinical studies, bridging the gap between experimental science and clinical medicine. We have discussed pathogenesis, temporal kinetics, relationships to neuro-imaging, and, most importantly, clinical applicability in order to provide a holistic perspective of how this could improve TBI diagnosis and predict clinical outcome in a real-life setting. We conclude that early and reliable identification of axonal injury post-TBI with the help of body fluid biomarkers could enhance current care of TBI patients by (i) increasing speed and accuracy of diagnosis, (ii) providing invaluable prognostic information, (iii) allow efficient allocation of rehabilitation services, and (iv) provide potential therapeutic targets. The optimal model for assessing TAI is likely to involve multiple components, including several blood biomarkers and neuro-imaging modalities, at different time points. Copyright © 2018. Published by Elsevier B.V.

Comprehensive Evaluation of Altered Systemic Metabolism and Pancreatic Cancer Risk

DTIC Science & Technology

2015-10-01

aspirin and β-carotene among 22 071 male physicians, age 40 to 84 years. After trial completion in 1995, participants were followed as an observational...report on the aspirin component of the ongoing Physicians’ Health Study. Steering Committee of the Physicians’ Health Study Research Group. N Engl...Study I (PHS I) is a randomized clinical trial of aspirin and β-carotene that enrolled 22,071 male physicians aged 40 to 84 years in 1982. After

Progress in translational research on intracerebral hemorrhage: Is there an end in sight?

PubMed Central

Xi, Guohua; Strahle, Jennifer; Hua, Ya; Keep, Richard F.

2013-01-01

Intracerebral hemorrhage (ICH) is a common and often fatal stroke subtype for which specific therapies and treatments remain elusive. To address this, many recent experimental and translational studies of ICH have been conducted, and these have led to several ongoing clinical trials. This review focuses on the progress of translational studies of ICH including those of the underlying causes and natural history of ICH, animal models of the condition, and effects of ICH on the immune and cardiac systems, among others. Current and potential clinical trials also are discussed for both ICH alone and with intraventricular extension. PMID:24139872

Assessing the extent to which current clinical research is consistent with patient priorities: a scoping review using a case study in patients on or nearing dialysis.

PubMed

Jun, Min; Manns, Braden; Laupacis, Andreas; Manns, Liam; Rehal, Bhavdeep; Crowe, Sally; Hemmelgarn, Brenda R

2015-01-01

There is growing acknowledgement that engaging patients to identify their research priorities is important. Using a case study of patients on or nearing dialysis, we sought to assess the extent to which recently completed and ongoing clinical research was consistent with priorities identified by patients, caregivers, and clinicians. Over a 4-year sampling frame (January 2010 to December 2013), we systematically searched the medical literature (top 5 nephrology and top 10 general medicine journals accessed through MEDLINE via Ovid), international randomized controlled trial (RCT) registries, and national government and kidney research funding organizations (Canada, U.S., Australia, and U.K.) for published clinical studies, registered RCTs, and funded clinical studies, respectively. Published clinical studies, registered RCTs, and funded clinical studies were categorized as to whether or not they were consistent with the top 10 research priorities identified by patients, their caregivers, and clinicians in a recent comprehensive research priority setting exercise. The search yielded 4293 published articles, 688 RCTs, and 70 funded studies, of which 1116 articles, 315 RCTs, and 70 funded studies were eligible for inclusion. Overall 194 published studies (17.4 %), 71 RCTs (22.5 %), and 15 funded studies (21.4 %) included topics consistent with the top 10 research priorities identified by patients. Four of the top 10 research priorities, including strategies to improve the management of itching, increase access to kidney transplantation, assess the psychosocial impact of kidney failure, and determine the effects of dietary restriction received virtually no attention. The top 10 priorities we used to categorize included studies were identified by Canadian patients, caregivers, and clinicians. The top research priorities may vary across different countries. The proportion of published studies that are consistent with the top 10 priorities could be different in nephrology journals with lower impact factors. Studies related to kidney transplantation and the psychosocial impact of kidney failure may have been published in journals not included in our search strategy. The majority of recently completed or ongoing clinical studies in patients on or nearing dialysis do not address the top research priorities of patients, raising concerns that current clinical research may not be meeting the needs of the ultimate consumer, in this case, patients on or nearing dialysis. Greater involvement of patients in research is required to bridge the gap between research and patients' needs.

Anti-Müllerian hormone concentrations and antral follicle counts for the prediction of pregnancy outcomes after intrauterine insemination.

PubMed

Moro, Francesca; Tropea, Anna; Scarinci, Elisa; Leoncini, Emanuele; Boccia, Stefania; Federico, Alex; Alesiani, Ornella; Lanzone, Antonio; Apa, Rosanna

2016-04-01

To evaluate anti-Müllerian hormone (AMH) concentrations and antral follicle counts (AFCs) in the prediction of pregnancy outcomes after controlled ovarian stimulation among women undergoing intrauterine insemination. A retrospective study included women with unexplained infertility aged 41years or younger who attended a fertility clinic in Italy between December 2009 and May 2014. Ovarian stimulation was achieved with recombinant follicle-stimulating hormone or highly purified human menopausal gonadotropin. Receiver operating characteristic curves were generated to predict ongoing pregnancy. The primary outcome was the association between AMH/AFC and ongoing pregnancy, and was assessed by logistic regression. Overall, 276 women were included, of whom 43 (15.6%) achieved ongoing pregnancy. Multivariate analysis showed that women with a serum day-3 concentration of AMH higher than 2.3ng/mL were more likely to have ongoing pregnancy than were those with a concentration lower than 2.3ng/mL (odds ratio 5.84, 95% confidence interval 2.38-14.31; P<0.001). No associations were recorded for AFCs. AMH should be used to predict the pregnancy outcome of intrauterine insemination. Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Critical evaluation of the efficacy and tolerability of azilsartan.

PubMed

De Caterina, Alberto R; Harper, Andrew R; Cuculi, Florim

2012-01-01

Appropriate control of blood pressure (BP) in hypertensive patients still represents the major therapeutic goal in the treatment of hypertension. Despite the growing attention and wide range of antihypertensive agents available in the clinical scenario, the target of BP below the advised thresholds of 140/90 mmHg is, unfortunately, often unreached. For this reason, the search for new antihypertensive agents is still ongoing. Azilsartan medoxomil, a new angiotensin receptor blocker that has been recently introduced in the clinical arena, represents the eighth angiotensin receptor blocker currently available for BP control. The aim of this paper is to describe the efficacy and safety profile of this new compound, reviewing available data obtained from both pre-clinical and clinical studies.

Critical evaluation of the efficacy and tolerability of azilsartan

PubMed Central

De Caterina, Alberto R; Harper, Andrew R; Cuculi, Florim

2012-01-01

Appropriate control of blood pressure (BP) in hypertensive patients still represents the major therapeutic goal in the treatment of hypertension. Despite the growing attention and wide range of antihypertensive agents available in the clinical scenario, the target of BP below the advised thresholds of 140/90 mmHg is, unfortunately, often unreached. For this reason, the search for new antihypertensive agents is still ongoing. Azilsartan medoxomil, a new angiotensin receptor blocker that has been recently introduced in the clinical arena, represents the eighth angiotensin receptor blocker currently available for BP control. The aim of this paper is to describe the efficacy and safety profile of this new compound, reviewing available data obtained from both pre-clinical and clinical studies. PMID:22661897

The mourning-liberation process in health and disease.

PubMed

Pollock, G H

1987-09-01

In this article I have presented my own research on the mourning-liberation process and related it to some of the ongoing work as well as past pioneering clinical studies of this adaptational process. Included in the references at the end of this paper is a listing of my published works on the mourning research, in chronologic order, for those who may wish to study aspects of what has been reported in greater detail.

Thyroid stimulating hormone suppression post-therapy in patients with Graves' disease: a systematic review of pathophysiology and clinical data.

PubMed

Yu, Huan; Farahani, Pendar

2015-04-08

Post-treatment hypothyroidism is common in Graves' disease, and clinical guidelines recommend monitoring for it; however, thyroid stimulating hormone (TSH) can remain suppressed in these patients following treatment. The objectives of this study were to explore the proposed pathophysiology behind the phenomenon of post-therapy TSH suppression and to systematically review existing clinical data on post-therapy TSH suppression in patients with Graves' disease. A systematic literature search was performed using EMBASE and PubMed databases, with several combinations of MeSH terms. Bibliography mining was also done on relevant articles to be as inclusive as possible. A total of 18 articles described possible mechanisms for post-therapy TSH suppression. Several of the studies demonstrate evidence of thyrotroph atrophy and hypothesize that this contributes to the ongoing suppression. TSH receptors have been identified in folliculo-stellate cells of the pituitary as well as astroglial cells of the hypothalamus, mediating paracrine feedback. A few studies have demonstrated inverse correlation between autoantibody titres and TSH levels, suggestive of their role in mediating ongoing TSH suppression in patients with Graves' disease. In addition, five studies were identified that provided clinical data on the duration of TSH suppression. Combined data show that 45.5% of patients recover TSH by 3 months after treatment, increasing to 69.3% by 6 months, and plateauing to 73.8% by 12 months (p>0.0001). Sub-analysis also shows that for patients who are TBII negative, 80.7% recover their TSH by 6 months compared with only 58.7% in those who are TBII positive (p= 0.003). Clinical data suggests that TSH recovery is most likely to occur within the first 6 months after treatment, with recovery plateauing at approximately 70% of patients, suggesting that reliance on this assay for monitoring can be very misleading. Furthermore, TBII positivity is associated with lower likelihood of TSH recovery. Pathophysiology behind suppressed TSH involves not only anatomical but also autoimmune mechanisms.

Clinical nurse leaders' and academics' perspectives in clinical assessment of final-year nursing students: A qualitative study.

PubMed

Wu, Xi Vivien; Enskär, Karin; Pua, Lay Hoon; Heng, Doreen Gek Noi; Wang, Wenru

2017-09-01

The nature of nursing practice is diverse; therefore, clinical assessment is a complex process. This study explores the perceptions of clinical nurse leaders and academics on clinical assessment for undergraduate nursing education during transition to practice. An explorative qualitative approach was applied. Eight nurse managers, six clinical nurse educators, and eight academics from two tertiary hospitals and a university in Singapore participated in four focus group discussions. Thematic analysis was conducted. Four overriding themes were revealed: the need for a valid and reliable clinical assessment tool, preceptors' competency in clinical assessment, challenges encountered by the students in clinical assessment, and the need for close academic and clinical collaboration to support preceptors and students. Closer academic-clinical partnership is recommended to review the clinical education curriculum. Clinical and educational institutions need to work closely to design a learning program to enhance preceptors' competence in clinical pedagogy and assessment. Furthermore, a stress management program could build students' resiliency in coping with unfamiliar clinical environments. Ongoing support needs to be provided for both preceptors and students to enrich the preceptorship and learning experiences. © 2017 John Wiley & Sons Australia, Ltd.

Pregnancy as a Window to Future Cardiovascular Health: Design and Implementation of the nuMoM2b Heart Health Study

PubMed Central

Haas, David M; Ehrenthal, Deborah B; Koch, Matthew A; Catov, Janet M; Barnes, Shannon E; Facco, Francesca; Parker, Corette B; Mercer, Brian M; Bairey-Merz, C Noel; Silver, Robert M; Wapner, Ronald J; Simhan, Hyagriv N; Hoffman, Matthew K; Grobman, William A; Greenland, Philip; Wing, Deborah A; Saade, George R; Parry, Samuel; Zee, Phyllis C; Reddy, Uma M; Pemberton, Victoria L; Burwen, Dale R

2016-01-01

Abstract The National Institute of Child Health and Human Development's Nulliparous Pregnancy Outcomes Study-Monitoring Mothers-to-Be (nuMoM2b) Heart Health Study (HHS) was designed to investigate the relationships between adverse pregnancy outcomes and modifiable risk factors for cardiovascular disease. The ongoing nuMoM2b-HHS, which started in 2013, is a prospective follow-up of the nuMoM2b cohort, which included 10,038 women recruited between 2010 and 2013 from 8 centers across the United States who were initially observed over the course of their first pregnancies. In this report, we detail the design and study procedures of the nuMoM2b-HHS. Women in the pregnancy cohort who consented to be contacted for participation in future studies were approached at 6-month intervals to ascertain health information and to maintain ongoing contact. Two to 5 years after completion of the pregnancy documented in the nuMoM2b, women in the nuMoM2b-HHS were invited to an in-person study visit. During this visit, they completed psychosocial and medical history questionnaires and had clinical measurements and biological specimens obtained. A subcohort of participants who had objective assessments of sleep-disordered breathing during pregnancy were asked to repeat this investigation. This unique prospective observational study includes a large, geographically and ethnically diverse cohort, rich depth of phenotypic information about adverse pregnancy outcomes, and clinical data and biospecimens from early in the index pregnancy onward. Data obtained from this cohort will provide mechanistic and clinical insights into how data on a first pregnancy can provide information about the potential development of subsequent risk factors for cardiovascular disease. PMID:26825925

Does time-lapse imaging have favorable results for embryo incubation and selection compared with conventional methods in clinical in vitro fertilization? A meta-analysis and systematic review of randomized controlled trials

PubMed Central

Yuan, Jing; Liu, Fenghua

2017-01-01

Objective The present study aimed to undertake a review of available evidence assessing whether time-lapse imaging (TLI) has favorable outcomes for embryo incubation and selection compared with conventional methods in clinical in vitro fertilization (IVF). Methods Using PubMed, EMBASE, Cochrane library and ClinicalTrial.gov up to February 2017 to search for randomized controlled trials (RCTs) comparing TLI versus conventional methods. Both studies randomized women and oocytes were included. For studies randomized women, the primary outcomes were live birth and ongoing pregnancy, the secondary outcomes were clinical pregnancy and miscarriage; for studies randomized oocytes, the primary outcome was blastocyst rate, the secondary outcome was good quality embryo on Day 2/3. Subgroup analysis was conducted based on different incubation and embryo selection between groups. Results Ten RCTs were included, four randomized oocytes and six randomized women. For oocyte-based review, the pool-analysis observed no significant difference between TLI group and control group for blastocyst rate [relative risk (RR) 1.08, 95% CI 0.94–1.25, I2 = 0%, two studies, including 1154 embryos]. The quality of evidence was moderate for all outcomes in oocyte-based review. For woman-based review, only one study provided live birth rate (RR 1,23, 95% CI 1.06–1.44,I2 N/A, one study, including 842 women), the pooled result showed no significant difference in ongoing pregnancy rate (RR 1.04, 95% CI 0.80–1.36, I2 = 59%, four studies, including 1403 women) between two groups. The quality of the evidence was low or very low for all outcomes in woman-based review. Conclusions Currently there is insufficient evidence to support that TLI is superior to conventional methods for human embryo incubation and selection. In consideration of the limitations and flaws of included studies, more well designed RCTs are still in need to comprehensively evaluate the effectiveness of clinical TLI use. PMID:28570713

Clinic, hospital try to fulfill vision of coordinated care with joint venture company.

PubMed

2000-09-01

Coordinated Care Services Inc., a joint venture of Carle Foundation and Carle Clinic Association in Urbana, IL, shares its initial successes and ongoing challenges after one year of operation. The biggest barrier to further improvements remains insufficient information management capability.

Nurse-Managed Clinics: A Blueprint for Success Using the Covey Framework.

ERIC Educational Resources Information Center

Starck, Patricia L.; And Others

1995-01-01

Describes the process from inception to successful operation of a university-based, nurse-managed clinic, based on Covey's seven habits of highly effective people. Includes information on the planning process, financing, political strategies for gaining approval, and ongoing development of services. (JOW)

Remotely-supervised transcranial direct current stimulation (tDCS) for clinical trials: guidelines for technology and protocols.

PubMed

Charvet, Leigh E; Kasschau, Margaret; Datta, Abhishek; Knotkova, Helena; Stevens, Michael C; Alonzo, Angelo; Loo, Colleen; Krull, Kevin R; Bikson, Marom

2015-01-01

The effect of transcranial direct current stimulation (tDCS) is cumulative. Treatment protocols typically require multiple consecutive sessions spanning weeks or months. However, traveling to clinic for a tDCS session can present an obstacle to subjects and their caregivers. With modified devices and headgear, tDCS treatment can be administered remotely under clinical supervision, potentially enhancing recruitment, throughput, and convenience. Here we propose standards and protocols for clinical trials utilizing remotely-supervised tDCS with the goal of providing safe, reproducible and well-tolerated stimulation therapy outside of the clinic. The recommendations include: (1) training of staff in tDCS treatment and supervision; (2) assessment of the user's capability to participate in tDCS remotely; (3) ongoing training procedures and materials including assessments of the user and/or caregiver; (4) simple and fail-safe electrode preparation techniques and tDCS headgear; (5) strict dose control for each session; (6) ongoing monitoring to quantify compliance (device preparation, electrode saturation/placement, stimulation protocol), with corresponding corrective steps as required; (7) monitoring for treatment-emergent adverse effects; (8) guidelines for discontinuation of a session and/or study participation including emergency failsafe procedures tailored to the treatment population's level of need. These guidelines are intended to provide a minimal level of methodological rigor for clinical trials seeking to apply tDCS outside a specialized treatment center. We outline indication-specific applications (Attention Deficit Hyperactivity Disorder, Depression, Multiple Sclerosis, Palliative Care) following these recommendations that support a standardized framework for evaluating the tolerability and reproducibility of remote-supervised tDCS that, once established, will allow for translation of tDCS clinical trials to a greater size and range of patient populations.

Ticagrelor for the treatment of atherosclerotic disease: insights from the PARTHENON clinical development program.

PubMed

Held, Peter; Himmelmann, Anders; Ditmarsch, Marc

2016-07-01

Ticagrelor (P2Y12 receptor antagonist) is presently indicated for preventing atherothrombotic events in patients with acute coronary syndrome and patients with a history of myocardial infarction. The PARTHENON clinical development program comprises five randomized, controlled, cardiovascular, indication-seeking outcome studies, aiming to evaluate ticagrelor across the spectrum of patients with atherothrombotic disease. Results of two large-scale trials support a benefit for ticagrelor in patients with acute coronary syndrome (PLATO; ClinicalTrials.gov: NCT00391872) and in patients with a history of myocardial infarction (PEGASUS-TIMI 54; ClinicalTrials.gov: NCT01225562). Ongoing trials will provide information on the efficacy and safety of ticagrelor in patients with acute ischemic stroke or transient ischemic attack (SOCRATES; ClinicalTrials.gov: NCT01994720), peripheral artery disease (EUCLID; ClinicalTrials.gov: NCT01732822) and coronary artery disease in patients with Type 2 diabetes mellitus (THEMIS: ClinicalTrials.gov: NCT01991795).

Interconnection: A qualitative analysis of adjusting to living with renal cell carcinoma

PubMed Central

LEAL, ISABEL; MILBURY, KATHRIN; ENGEBRETSON, JOAN; MATIN, SURENA; JONASCH, ERIC; TANNIR, NIZAR; WOOD, CHRISTOPHER G.; COHEN, LORENZO

2017-01-01

Objective Adjusting to cancer is an ongoing process, yet few studies explore this adjustment from a qualitative perspective. The aim of our qualitative study was to understand how patients construct their experience of adjusting to living with cancer. Method Qualitative analysis was conducted of written narratives collected from four separate writing sessions as part of a larger expressive writing clinical trial with renal cell carcinoma patients. Thematic analysis and constant comparison were employed to code the primary patterns in the data into themes until thematic saturation was reached at 37 participants. A social constructivist perspective informed data interpretation. Results Interconnection described the overarching theme underlying the process of adjusting to cancer and involved four interrelated themes: (1) discontinuity—feelings of disconnection and loss following diagnosis; (2) reorientation—to the reality of cancer psychologically and physically; (3) rebuilding—struggling through existential distress to reconnect; and (4) expansion—finding meaning in interconnections with others. Participants related a dialectical movement in which disruption and loss catalyzed an ongoing process of finding meaning. Significance of results Our findings suggest that adjusting to living with cancer is an ongoing, iterative, nonlinear process. The dynamic interactions between the different themes in this process describe the transformation of meaning as participants move through and revisit prior themes in response to fluctuating symptoms and medical news. It is important that clinicians recognize the dynamic and ongoing process of adjusting to cancer to support patients in addressing their unmet psychosocial needs throughout the changing illness trajectory. PMID:28262086

Interconnection: A qualitative analysis of adjusting to living with renal cell carcinoma.

PubMed

Leal, Isabel; Milbury, Kathrin; Engebretson, Joan; Matin, Surena; Jonasch, Eric; Tannir, Nizar; Wood, Christopher G; Cohen, Lorenzo

2018-04-01

ABSTRACTObjective:Adjusting to cancer is an ongoing process, yet few studies explore this adjustment from a qualitative perspective. The aim of our qualitative study was to understand how patients construct their experience of adjusting to living with cancer. Qualitative analysis was conducted of written narratives collected from four separate writing sessions as part of a larger expressive writing clinical trial with renal cell carcinoma patients. Thematic analysis and constant comparison were employed to code the primary patterns in the data into themes until thematic saturation was reached at 37 participants. A social constructivist perspective informed data interpretation. Interconnection described the overarching theme underlying the process of adjusting to cancer and involved four interrelated themes: (1) discontinuity-feelings of disconnection and loss following diagnosis; (2) reorientation-to the reality of cancer psychologically and physically; (3) rebuilding-struggling through existential distress to reconnect; and (4) expansion-finding meaning in interconnections with others. Participants related a dialectical movement in which disruption and loss catalyzed an ongoing process of finding meaning. Our findings suggest that adjusting to living with cancer is an ongoing, iterative, nonlinear process. The dynamic interactions between the different themes in this process describe the transformation of meaning as participants move through and revisit prior themes in response to fluctuating symptoms and medical news. It is important that clinicians recognize the dynamic and ongoing process of adjusting to cancer to support patients in addressing their unmet psychosocial needs throughout the changing illness trajectory.

What is the optimal means of preparing the endometrium in frozen-thawed embryo transfer cycles? A systematic review and meta-analysis.

PubMed

Groenewoud, Eva R; Cantineau, Astrid E P; Kollen, Boudewijn J; Macklon, Nick S; Cohlen, Ben J

2013-01-01

BACKGROUND Frozen-thawed embryo transfer (FET) enables surplus embryos derived from IVF or IVF-ICSI treatment to be stored and transferred at a later date. In recent years the number of FET cycles performed has increased due to transferring fewer embryos per transfer and improved laboratory techniques. Currently, there is little consensus on the most effective method of endometrium preparation prior to FET. METHODS Using both MEDLINE and EMBASE database a systematic review and meta-analysis of literature was performed. Case-series, case-control studies and articles in languages other than English, Dutch or Spanish were excluded. Those studies comparing clinical and ongoing pregnancy rates as well as live birth rates in (i) true natural cycle FET (NC-FET) versus modified NC-FET, (ii) NC-FET versus artificial cycle FET (AC-FET), (iii) AC-FET versus artificial with GnRH agonist cycle FET and (iv) NC-FET versus artificial with GnRH agonist cycle FET were included. Forest plots were constructed and relative risks or odds ratios were calculated. RESULTS A total of 43 publications were selected for critical appraisal and 20 articles were included in the final review. For all comparisons, no differences in the clinical pregnancy rate, ongoing pregnancy rate or live birth rate could be found. Based on information provided in the articles no conclusions could be drawn with regard to cancellation rates. CONCLUSIONS Based on the current literature it is not possible to identify one method of endometrium preparation in FET as being more effective than another. Therefore, all of the current methods of endometrial preparation appear to be equally successful in terms of ongoing pregnancy rate. However, in some comparisons predominantly retrospective studies were included leaving these comparisons subject to selection and publication bias. Also patients' preferences as well as cost-efficiency were not addressed in any of the included studies. Therefore, prospective randomized studies addressing these issues are needed.

Low versus high volume of culture medium during embryo transfer: a randomized clinical trial.

PubMed

Sigalos, George Α; Michalopoulos, Yannis; Kastoras, Athanasios G; Triantafyllidou, Olga; Vlahos, Nikos F

2018-04-01

The aim of this prospective randomized control trial was to evaluate if the use of two different volumes (20-25 vs 40-45 μl) of media used for embryo transfer affects the clinical outcomes in fresh in vitro fertilization (IVF) cycles. In total, 236 patients were randomized in two groups, i.e., "low volume" group (n = 118) transferring the embryos with 20-25 μl of medium and "high volume" group (n = 118) transferring the embryos with 40-45 μl of medium. The clinical pregnancy, implantation, and ongoing pregnancy rates were compared between the two groups. No statistically significant differences were observed in clinical pregnancy (46.8 vs 54.3%, p = 0.27), implantation (23.7 vs 27.8%, p = 0.30), and ongoing pregnancy (33.3 vs 40.0%, p = 0.31) rates between low and high volume group, respectively. Higher volume of culture medium to load the embryo into the catheter during embryo transfer does not influence the clinical outcome in fresh IVF cycles. NCT03350646.

Review of the Clinical and Biologic Aspects of Human Papillomavirus-Positive Squamous Cell Carcinomas of the Head and Neck

DOE Office of Scientific and Technical Information (OSTI.GOV)

Blitzer, Grace C.; Smith, Molly A.; Harris, Stephen L.

Human papillomavirus (HPV), a known etiology of a subset of head-and-neck squamous cell carcinomas (HNCs), causes numerous alterations in normal cellular functions. This article reviews the biology, detection, and treatment of HPV-positive HNC. The role of HPV oncoproteins in tumor development, the natural history of HPV infection, and risk factors for and prevention of transmission of oral HPV are considered. Commonly used methods for detecting HPV infection, including limitations of these methods, are discussed to aid the practicing clinician in using these tests in their clinical practice. Clinical characteristics of HPV-positive HNC, including potential explanations for the improved outcomes seenmore » in patients with HPV-positive HNC, are assessed. Ongoing clinical trials specific for patients with HPV-positive HNC are described, and areas in need of additional research are summarized. Until the results of ongoing trials are known, treatment of HPV-positive HNC should not differ in clinical practice from treatment of similar non-HPV related cancers.« less

Nanotechnology Strategies To Advance Outcomes in Clinical Cancer Care.

PubMed

Hartshorn, Christopher M; Bradbury, Michelle S; Lanza, Gregory M; Nel, Andre E; Rao, Jianghong; Wang, Andrew Z; Wiesner, Ulrich B; Yang, Lily; Grodzinski, Piotr

2018-01-23

Ongoing research into the application of nanotechnology for cancer treatment and diagnosis has demonstrated its advantages within contemporary oncology as well as its intrinsic limitations. The National Cancer Institute publishes the Cancer Nanotechnology Plan every 5 years since 2005. The most recent iteration helped codify the ongoing basic and translational efforts of the field and displayed its breadth with several evolving areas. From merely a technological perspective, this field has seen tremendous growth and success. However, an incomplete understanding of human cancer biology persists relative to the application of nanoscale materials within contemporary oncology. As such, this review presents several evolving areas in cancer nanotechnology in order to identify key clinical and biological challenges that need to be addressed to improve patient outcomes. From this clinical perspective, a sampling of the nano-enabled solutions attempting to overcome barriers faced by traditional therapeutics and diagnostics in the clinical setting are discussed. Finally, a strategic outlook of the future is discussed to highlight the need for next-generation cancer nanotechnology tools designed to address critical gaps in clinical cancer care.

Decreased shoulder function and pain common in recreational badminton players.

PubMed

Fahlström, M; Söderman, K

2007-06-01

The aim of this study was to describe the prevalence and consequences of painful conditions in the shoulder region in recreational badminton players. A questionnaire study was performed on 99 players, of whom 57 were also assessed with Constant score. Previous or present pain in the dominant shoulder was reported by 52% of the players. Sixteen percent of the players had on-going shoulder pain associated with badminton play. A majority of these players reported that their training habits were affected by the pain. Total Constant score was lower in the painful shoulders. Furthermore, range of active pain-free shoulder abduction was decreased. However, isometric shoulder strength test showed no differences when compared with pain-free shoulders. Even though the pain caused functional problems, the players were still playing with on-going symptoms. The diagnoses were mostly unknown, although history and clinical tests indicate problems resembling subacromial impingement.

A web-portal for interactive data exploration, visualization, and hypothesis testing

PubMed Central

Bartsch, Hauke; Thompson, Wesley K.; Jernigan, Terry L.; Dale, Anders M.

2014-01-01

Clinical research studies generate data that need to be shared and statistically analyzed by their participating institutions. The distributed nature of research and the different domains involved present major challenges to data sharing, exploration, and visualization. The Data Portal infrastructure was developed to support ongoing research in the areas of neurocognition, imaging, and genetics. Researchers benefit from the integration of data sources across domains, the explicit representation of knowledge from domain experts, and user interfaces providing convenient access to project specific data resources and algorithms. The system provides an interactive approach to statistical analysis, data mining, and hypothesis testing over the lifetime of a study and fulfills a mandate of public sharing by integrating data sharing into a system built for active data exploration. The web-based platform removes barriers for research and supports the ongoing exploration of data. PMID:24723882

Towards efficient use of research resources: a nationwide database of ongoing primary care research projects in the Netherlands.

PubMed

Kortekaas, Marlous F; van de Pol, Alma C; van der Horst, Henriëtte E; Burgers, Jako S; Slort, Willemjan; de Wit, Niek J

2014-04-01

PURPOSE. Although in the last decades primary care research has evolved with great success, there is a growing need to prioritize the topics given the limited resources available. Therefore, we constructed a nationwide database of ongoing primary care research projects in the Netherlands, and we assessed if the distribution of research topics matched with primary care practice. We conducted a survey among the main primary care research centres in the Netherlands and gathered details of all ongoing primary care research projects. We classified the projects according to research topic, relation to professional guidelines and knowledge deficits, collaborative partners and funding source. Subsequently, we compared the frequency distribution of clinical topics of research projects to the prevalence of problems in primary care practice. We identified 296 ongoing primary care research projects from 11 research centres. Most projects were designed as randomized controlled trial (35%) or observational cohort (34%), and government funded mostly (60%). Thematically, most research projects addressed chronic diseases, mainly cardiovascular risk management (8%), depressive disorders (8%) and diabetes mellitus (7%). One-fifth of the projects was related to defined knowledge deficits in primary care guidelines. From a clinical primary care perspective, research projects on dermatological problems were significantly underrepresented (P = 0.01). This survey of ongoing projects demonstrates that primary care research has a firm basis in the Netherlands, with a strong focus on chronic disease. The fit with primary care practice can improve, and future research should address knowledge deficits in professional guidelines more.

Segmentation methods for breast vasculature in dual-energy contrast-enhanced digital breast tomosynthesis

NASA Astrophysics Data System (ADS)

Lau, Kristen C.; Lee, Hyo Min; Singh, Tanushriya; Maidment, Andrew D. A.

2015-03-01

Dual-energy contrast-enhanced digital breast tomosynthesis (DE CE-DBT) uses an iodinated contrast agent to image the three-dimensional breast vasculature. The University of Pennsylvania has an ongoing DE CE-DBT clinical study in patients with known breast cancers. The breast is compressed continuously and imaged at four time points (1 pre-contrast; 3 post-contrast). DE images are obtained by a weighted logarithmic subtraction of the high-energy (HE) and low-energy (LE) image pairs. Temporal subtraction of the post-contrast DE images from the pre-contrast DE image is performed to analyze iodine uptake. Our previous work investigated image registration methods to correct for patient motion, enhancing the evaluation of vascular kinetics. In this project we investigate a segmentation algorithm which identifies blood vessels in the breast from our temporal DE subtraction images. Anisotropic diffusion filtering, Gabor filtering, and morphological filtering are used for the enhancement of vessel features. Vessel labeling methods are then used to distinguish vessel and background features successfully. Statistical and clinical evaluations of segmentation accuracy in DE-CBT images are ongoing.

Ongoing Use of Data and Specimens from NCI Sponsored Cancer Prevention Clinical Trials in the Community Clinical Oncology Program

PubMed Central

Minasian, Lori; Tangen, Catherine M.; Wickerham, D. Lawrence

2015-01-01

Large cancer prevention trials provide opportunities to collect a wide array of data and biospecimens at study entry and longitudinally, for a healthy, aging population without cancer. This provides an opportunity to use pre-diagnostic data and specimens to evaluate hypotheses about the initial development of cancer. This paper reports on strides made by, and future possibilities for, the use of accessible biorepositories developed from precisely annotated samples obtained through large-scale National Cancer Institute (NCI)-sponsored cancer prevention clinical trials conducted by the NCI Cooperative Groups. These large cancer prevention studies, which have enrolled over 80,000 volunteers, continue to contribute to our understanding of cancer development more than 10 years after they were closed. PMID:26433556

Mechanisms and Effects of Transcranial Direct Current Stimulation

PubMed Central

Giordano, James; Bikson, Marom; Kappenman, Emily S.; Clark, Vincent P.; Coslett, H. Branch; Hamblin, Michael R.; Hamilton, Roy; Jankord, Ryan; Kozumbo, Walter J.; McKinley, R. Andrew; Nitsche, Michael A.; Reilly, J. Patrick; Richardson, Jessica; Wurzman, Rachel

2017-01-01

The US Air Force Office of Scientific Research convened a meeting of researchers in the fields of neuroscience, psychology, engineering, and medicine to discuss most pressing issues facing ongoing research in the field of transcranial direct current stimulation (tDCS) and related techniques. In this study, we present opinions prepared by participants of the meeting, focusing on the most promising areas of research, immediate and future goals for the field, and the potential for hormesis theory to inform tDCS research. Scientific, medical, and ethical considerations support the ongoing testing of tDCS in healthy and clinical populations, provided best protocols are used to maximize safety. Notwithstanding the need for ongoing research, promising applications include enhancing vigilance/attention in healthy volunteers, which can accelerate training and support learning. Commonly, tDCS is used as an adjunct to training/rehabilitation tasks with the goal of leftward shift in the learning/treatment effect curves. Although trials are encouraging, elucidating the basic mechanisms of tDCS will accelerate validation and adoption. To this end, biomarkers (eg, clinical neuroimaging and findings from animal models) can support hypotheses linking neurobiological mechanisms and behavioral effects. Dosage can be optimized using computational models of current flow and understanding dose–response. Both biomarkers and dosimetry should guide individualized interventions with the goal of reducing variability. Insights from other applied energy domains, including ionizing radiation, transcranial magnetic stimulation, and low-level laser (light) therapy, can be prudently leveraged. PMID:28210202

Immunosuppression by hypoxic cell radiosensitizers: a phenomenon of potential clinical importance

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rockwell, S.; Kapp, D.S.

1982-06-01

The nitroimidazoles metronidazole, misonidazol, and desmethyl misonidazole are currently undergoing clinical trials as possible adjuncts to radiotherapy. Ongoing clinical trials are evaluating the effectiveness of these agents and also documenting the pharmacokinetics and toxicities of radiosensitizing doses of these drugs in man. A variety of toxic effects have been noted in man, including anorexia, nausea and vomiting, peripheral neuropathy, central nervous system symptoms, ototoxicity, allergy, and fear. Laboratory studies have also suggested that these agents have potential to be mutagenic, carcinogenic, and teratogenic. In the editorial presented, the author attempts to draw attention to an additional toxic effect of nitroimidazolesmore » - the inhibition of cell-mediated immune responses. (JMT)« less

Recommendations for Clinical Decision Support Deployment: Synthesis of a Roundtable of Medical Directors of Information Systems

PubMed Central

Jenders, Robert A.; Osheroff, Jerome A.; Sittig, Dean F.; Pifer, Eric A.; Teich, Jonathan M

2007-01-01

Background: Ample evidence exists that clinical decision support (CDS) can improve clinician performance. Nevertheless, additional evidence demonstrates that clinicians still do not perform adequately in many instances. This suggests an ongoing need for implementation of CDS, in turn prompting development of a roadmap for national action regarding CDS. Objective: Develop practical advice to aid CDS implementation in order to improve clinician performance. Method: Structured group interview during a roundtable discussion by medical directors of information systems (N = 30), with subsequent review by participants and synthesis. Results: Participant consensus was that CDS should be comprehensive and should involve techniques such as order sets and facilitated documentation as well as alerts; should be subject to ongoing feedback; and should flow from and be governed by an organization’s clinical goals. Conclusion: A structured roundtable discussion of clinicians experienced in health information technology can yield practical, consensus advice for implementation of CDS. PMID:18693858

Clinical Investigation Program Annual Progress Report

DTIC Science & Technology

1993-09-30

272 93/200A 0 Comparison of Healing Rates of Bones Plated Following Fracture, Among Yucatan Swine Having Open and Closed Physes...Study Objective: Compare two enteral formulas in respect to nutritional aspects. (16) Technical Approach: Protocol will take place in SICU. (17...Protocol #: 93/200A (3) Status: Ongoing (4) Title: Comparison of Healing Rates of Bones Plated Following Fractures, Among Yucatan Swine Having Open and

Hysteroscopic polypectomy prior to infertility treatment: A cost analysis and systematic review.

PubMed

Mouhayar, Youssef; Yin, Ophelia; Mumford, Sunni L; Segars, James H

2017-06-01

The cost of fertility treatment is expensive and interventions that reduce cost can lead to greater efficiency and fewer embryos transferred. Endometrial polyps contribute to infertility and are frequently removed prior to infertility treatment. It is unclear whether polypectomy reduces fertility treatment cost and if so, the magnitude of cost reduction afforded by the procedure. The aim of this study was to determine whether performing office or operative hysteroscopic polypectomy prior to infertility treatment would be cost-effective. PubMed, Embase, and Cochrane libraries were used to identify publications reporting pregnancy rates after hysteroscopic polypectomy. Studies were required to have a polypectomy treatment group and control group of patients with polyps that were not resected. The charges of infertility treatments and polypectomy were obtained through infertility organizations and a private healthcare cost reporting website. These charges were applied to a decision tree model over the range of pregnancy rates observed in the representative studies to calculate an average cost per clinical or ongoing pregnancy. A sensitivity analysis was conducted to assess cost savings of polypectomy over a range of pregnancy rates and polypectomy costs. Pre-treatment office or operative hysteroscopic polypectomy ultimately saved €6658 ($7480) and €728 ($818), respectively, of the average cost per clinical pregnancy in women treated with four cycles of intrauterine insemination. Polypectomy prior to intrauterine insemination was cost-effective for clinical pregnancy rates greater than 30.2% for office polypectomy and 52.6% for operative polypectomy and for polypectomy price <€4414 ($4959). Office polypectomy or operative polypectomy saved €15,854 ($17,813) and €6644 ($7465), respectively, from the average cost per ongoing pregnancy for in vitro fertilization/intracytoplasmic sperm injection treated women and was cost-effective for ongoing pregnancy rates greater than 26.4% (office polypectomy) and 31.7% (operative polypectomy) and polypectomy price <€6376 ($7164). These findings suggested that office or operative hysteroscopic polypectomy was cost-effective when performed prior to both intrauterine insemination and in vitro fertilization over a range of plausible pregnancy rates and procedural costs. Copyright © 2017 Elsevier B.V. All rights reserved.

PTSD symptoms, satisfaction with life, and prejudicial attitudes toward the adversary among Israeli civilians exposed to ongoing missile attacks.

PubMed

Besser, Avi; Neria, Yuval

2009-08-01

Few studies have examined the consequences of exposure to ongoing missile attacks in civilian populations. The authors examine the relationships between such exposure, and posttraumatic stress disorder (PTSD), satisfaction with life, and prejudicial attitudes toward the adversary. By using a stratified probability sampling, 160 adults, exposed to repeated missile attacks in southern Israel, were compared to 181 adults from areas outside the range of these attacks. Exposed participants reported more PTSD symptoms and less satisfaction with life, as compared to unexposed participants. The associations between PTSD and satisfaction with life and between PTSD and prejudicial attitudes were significantly stronger among the exposed participants, as compared to those who were not exposed to the attacks. Theoretical and clinical implications of the findings are discussed.

Update on clinical trials in Dysphagia.

PubMed

Logemann, Jeri A

2006-04-01

Randomized clinical trials (RCTs) are often known as the gold standard in treatment efficacy studies. This article defines the characteristics of RCTs and the factors that investigators must consider in designing clinical trials in dysphagia. Design issues unique to behavioral treatments often used in dysphagia are discussed. Ongoing RCTs in dysphagia are described including studies of (1) the effectiveness of the Shaker exercise versus standardized treatment in patients with severe dysphagia resulting from stroke or treatment for head and neck cancer who have been nonoral for at least three months; (2) the comparative effects of nectar- and honey-thickened liquids versus chin tuck posture and in patients with dementia or Parkinson's disease with or without dementia who aspirate on thin liquids; and (3) the comparative effects of muscle exercise versus sensory postural therapy for dysphagia resulting from treatment for head and neck cancer. Issues in generalizing from the results of clinical trials are also described.

Neratinib for the treatment of breast cancer.

PubMed

Prové, Annemie; Dirix, Luc

2016-10-03

Neratinib is an orally available, pan-HER inhibitor with clinical activity in patients with HER2-amplified and HER2-mutated breast cancer. Areas Covered. A summary of publically available and relevant clinical data on neratinib. Expert Opinion. Neratinib (N) is clearly distinct from lapatinib (L), a difference based on its broad anti-HER effect, its covalent target binding and its toxicity profile. The main toxicity of neratinib is gastro-intestinal and is essentially limited to diarrhea. Although not directly compared with single agent lapatinib, skin toxicity is much less pronounced with N. The direct clinical comparison of N-capecitabine versus L-capecitabine is the subject of the ongoing NALA-trial. In patients with advanced disease, neratinib has clinically relevant activity in patients with trastuzumab(T)-pretreated and unpretreated disease. In patients having completed one year of adjuvant trastuzumab, an additional year of neratinib further reduces the risk of recurrence of invasive disease. The activity of neratinib in HER2-mutated advanced disease is subject of ongoing clinical trials but preclinical and early clinical results are promising. Neratinib is a usefull drug and a valuable addition to the different anti-HER2-drugs avalaible for patients with HER2-overexpressing and HER2-mutated breast cancer.

Arterial blood gases during and their dynamic changes after cardiopulmonary resuscitation: A prospective clinical study.

PubMed

Spindelboeck, Walter; Gemes, Geza; Strasser, Christa; Toescher, Kathrin; Kores, Barbara; Metnitz, Philipp; Haas, Josef; Prause, Gerhard

2016-09-01

An arterial blood gas analysis (ABG) yields important diagnostic information in the management of cardiac arrest. This study evaluated ABG samples obtained during out-of-hospital cardiopulmonary resuscitation (OHCPR) in the setting of a prospective multicenter trial. We aimed to clarify prospectively the ABG characteristics during OHCPR, potential prognostic parameters and the ABG dynamics after return of spontaneous circulation (ROSC). ABG samples were collected and instantly processed either under ongoing OHCPR performed according to current advanced life support guidelines or immediately after ROSC and data ware entered into a case report form along with standard CPR parameters. During a 22-month observation period, 115 patients had an ABG analysis during OHCPR. In samples obtained under ongoing CPR, an acidosis was present in 98% of all cases, but was mostly of mixed hypercapnic and metabolic origin. Hypocapnia was present in only 6% of cases. There was a trend towards higher paO2 values in patients who reached sustained ROSC, and a multivariate regression analysis revealed age, initial rhythm, time from collapse to CPR initiation and the arterio-alveolar CO2 difference (AaDCO2) to be associated with sustained ROSC. ABG samples drawn immediately after ROSC demonstrated higher paO2 and unaltered pH and base excess levels compared with samples collected during ongoing CPR. Our findings suggest that adequate ventilation and oxygenation deserve more research and clinical attention in the management of cardiac arrest and that oxygen uptake improves within minutes after ROSC. Hyperventilation resulting in arterial hypocapnia is not a major problem during OHCPR. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Differentiated thyroid cancer in children: Heterogeneity of predictive risk factors.

PubMed

Russo, Marco; Malandrino, Pasqualino; Moleti, Mariacarla; Vermiglio, Francesco; D'Angelo, Antonio; La Rosa, Giuliana; Sapuppo, Giulia; Calaciura, Francesca; Regalbuto, Concetto; Belfiore, Antonino; Vigneri, Riccardo; Pellegriti, Gabriella

2018-05-16

To correlate clinical and pathological characteristics at diagnosis with patient long-term outcomes and to evaluate ongoing risk stratifications in a large series of paediatric differentiated thyroid cancers (DTC). Retrospective analysis of clinical and pathological prognostic factors of 124 paediatric patients with DTC (age at diagnosis <19 years) followed up for 10.4 ± 8.4 years. Patients with a follow-up >3 years (n = 104) were re-classified 18 months after surgery on the basis of their response to therapy (ongoing risk stratification). Most patients had a papillary histotype (96.0%), were older than 15 years (75.0%) and were diagnosed because of clinical local symptoms (63.7%). Persistent/recurrent disease was present in 31.5% of cases during follow-up, but at the last evaluation, only 12.9% had biochemical or structural disease. The presence of metastases in the lymph nodes of the lateral compartment (OR 3.2, 95% CI, 1.28-7.16, P = 0.01) was the only independent factor associated with recurrent/persistent disease during follow-up. At the last evaluation, biochemical/structural disease was associated with node metastases (N1a, N1b) by univariate but not multivariate analysis. Ongoing risk stratification compared to the initial risk classification method better identified patients with a lower probability of persistent/recurrent disease (NPV = 100%). In spite of the aggressive presentations at diagnosis, paediatric patients with DTC show an excellent response to treatment and often a favourable outcome. N1b status should be considered a strong predictor of persistent/recurrent disease which, as in adults, is better predicted by ongoing risk stratification. © 2018 Wiley Periodicals, Inc.

Treatment planning capability assessment of a beam shaping assembly for accelerator-based BNCT.

PubMed

Herrera, M S; González, S J; Burlon, A A; Minsky, D M; Kreiner, A J

2011-12-01

Within the frame of an ongoing project to develop a folded Tandem-Electrostatic-Quadrupole accelerator facility for Accelerator-Based Boron Neutron Capture Therapy (AB-BNCT) a theoretical study was performed to assess the treatment planning capability of different configurations of an optimized beam shaping assembly for such a facility. In particular this study aims at evaluating treatment plans for a clinical case of Glioblastoma. Copyright © 2011 Elsevier Ltd. All rights reserved.

Feasibility of encoding the Institute for Clinical Systems Improvement Depression Guideline using the Omaha System.

PubMed

Monsen, Karen A; Neely, Claire; Oftedahl, Gary; Kerr, Madeleine J; Pietruszewski, Pam; Farri, Oladimeji

2012-08-01

Evidence-based clinical guidelines are being developed to bridge the gap between research and practice with the goals of improving health care quality and population health. However, disseminating, implementing, and ensuring ongoing use of clinical guidelines in practice settings is challenging. The purpose of this study was to demonstrate the feasibility of encoding evidence-based clinical guidelines using the Omaha System. Clinical documentation with Omaha System-encoded guidelines generates individualized, meaningful data suitable for program evaluation and health care quality research. The use of encoded guidelines within the electronic health record has potential to reinforce use of guidelines, and thus improve health care quality and population health. Research using Omaha System data generated by clinicians has potential to discover new knowledge related to guideline use and effectiveness. Copyright © 2012 Elsevier Inc. All rights reserved.

Gemigliptin, a novel dipeptidyl peptidase 4 inhibitor: first new anti-diabetic drug in the history of Korean pharmaceutical industry.

PubMed

Kim, Sung-Ho; Lee, Sung-Hack; Yim, Hyeon-Joo

2013-10-01

Gemigliptin, a potent, selective and long-acting DPP 4 inhibitor was developed by LG Life Sciences and approved for use in patients with type 2 diabetes mellitus by the Korean Food and Drug Administration in June 2012 under the trade name Zemiglo(®). Clinical pharmacokinetic and pharmacodynamic data suggest the efficacy and once daily dosing of gemigliptin. In clinical phase III studies, gemigliptin was efficacious as either monotherapy or combination therapy (add-on to metformin) and well tolerated in patients with type 2 diabetes. Further development of combination therapy is on-going.

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

PubMed

Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

2015-01-01

In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

PubMed Central

Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

2015-01-01

Background In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA’s pre-market approval (PMA) pathway. Methods and results We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. PMID:26060416

A pre-clinical safety study of PEGylated recombinant human endostatin (M2ES) in Sprague Dawley rats.

PubMed

Geng, Xingchao; Guo, Lifang; Liu, Li; Wang, Chao; Peng, Qian; Qi, Weihong; Sun, Li; Liu, Xiaomeng; Miao, Yufa; Lin, Zhi; Fu, Yan; Luo, Yongzhang; Li, Bo

2018-06-01

PEGylated recombinant human endostatin (M 2 ES) exhibited prolonged serum half-life and enhanced antitumor activity when compared with endostatin. A pre-clinical study was performed to evaluate the safety of M 2 ES in rats. After intravenous (IV) infusions of M 2 ES at a dose level of 3, 15 and 75 mg/kg in Sprague Dawley (SD) rats, M 2 ES was well tolerated in animals, with no observable changes in clinical observation, body weight, food consumption, urine analysis, hematology and serum biochemical analysis. The increase of kidney weights, and slight to severe vacuolation and necrosis of proximal tubule epithelial cells in kidney were observed in 15 and 75 mg/kg M 2 ES groups, but this adverse-effect was reversible. In summary, the major toxicity target organ of M 2 ES might be kidney, and the no observed adverse effect level (NOAEL) of M 2 ES in rats was 3 mg/kg in this study. These pre-clinical safety data contribute to the initiation of the ongoing clinical study. Copyright © 2018. Published by Elsevier Inc.

Validation of Biomarkers for Prostate Cancer Prognosis

DTIC Science & Technology

2014-12-01

and Muc1. We have also completed a project in image analysis of H & E slides with Gustavo Ayala at University of Texas. Finally, we have completed...Groups using the resource include Dr. Jeremy Squire, Dr. Gustavo Ayala, Tamara Lotan and Dr. Lidong Liu. • Porting final clinical data that will be...with a manuscript near completion. • Ongoing analysis of AZGP1 with a manuscript expected soon. • Ongoing analysis of image analysis with Gustavo Ayala

Impact of four training conditions on physician use of a web-based clinical decision support system.

PubMed

Kealey, Edith; Leckman-Westin, Emily; Finnerty, Molly T

2013-09-01

Training has been identified as an important barrier to implementation of clinical decision support systems (CDSSs), but little is known about the effectiveness of different training approaches. Using an observational retrospective cohort design, we examined the impact of four training conditions on physician use of a CDSS: (1) computer lab training with individualized follow-up (CL-FU) (n=40), (2) computer lab training without follow-up (CL) (n=177), (3) lecture demonstration (LD) (n=16), or (4) no training (NT) (n=134). Odds ratios of any use and ongoing use under training conditions were compared to no training over a 2-year follow-up period. CL-FU was associated with the highest percent of active users and odds for any use (90.0%, odds ratio (OR)=10.2, 95% confidence interval (CI): 3.2-32.9) and ongoing use (60.0%, OR=6.1 95% CI: 2.6-13.7), followed by CL (any use=81.4%, OR=5.3, CI: 2.9-9.6; ongoing use=28.8%, OR=1.7, 95% CI: 1.0-3.0). LD was not superior to no training (any use=47%, ongoing use=22.4%). Training format may have differential effects on initial and long-term follow-up of CDSSs use by physicians. Copyright © 2013 Elsevier B.V. All rights reserved.

Deep Brain Stimulation in Early Parkinson’s Disease: Enrollment Experience from a Pilot Trial

PubMed Central

Charles, PD; Dolhun, RM; Gill, CE; Davis, TL; Bliton, MJ; Tramontana, MG; Salomon, RM; Wang; Hedera, P; Phibbs, FT; Neimat, JS; Konrad, PE

2011-01-01

Background Deep brain stimulation (DBS) of the subthalamic nucleus is an accepted therapy for advanced Parkinson’s disease (PD). In animal models, pharmacologic ablation and stimulation of the subthalamic nucleus have resulted in clinical improvement and, in some cases, improved survival of dopaminergic neurons. DBS has not been studied in the early stages of PD, but early application should be explored to evaluate safety, efficacy, and the potential to alter disease progression. Methods We are conducting a prospective, randomized, single-blind clinical trial of optimal drug therapy (ODT) compared to medication plus DBS (ODT + DBS) in subjects with Hoehn & Yahr Stage II idiopathic PD who are without motor fluctuations or dementia. We report here subject screening, enrollment, baseline characteristics, and adverse events. Results 30 subjects (average age 60 ± 6.9 years, average duration of medicine 2.1 ± 1.3 years, average UPDRS-III scores 14.9 on medication and 27.0 off medication) are enrolled in the ongoing study. Twelve of 15 subjects randomized to DBS experienced perioperative adverse events, the majority of which were related to the procedure or device and resolved without sequelae. Frequently reported adverse events included wound healing problems, headache, edema, and confusion. Conclusion This report demonstrates that subjects with early stage PD can be successfully recruited, consented and retained in a long term clinical trial of DBS. Our ongoing pilot investigation will provide important preliminary safety and tolerability data concerning the application of DBS in early stage PD. PMID:22104012

Design and Implementation of a Randomized Controlled Trial of Genomic Counseling for Patients with Chronic Disease

PubMed Central

Sweet, Kevin; Gordon, Erynn S.; Sturm, Amy C.; Schmidlen, Tara J.; Manickam, Kandamurugu; Toland, Amanda Ewart; Keller, Margaret A.; Stack, Catharine B.; García-España, J. Felipe; Bellafante, Mark; Tayal, Neeraj; Embi, Peter; Binkley, Philip; Hershberger, Ray E.; Sadee, Wolfgang; Christman, Michael; Marsh, Clay

2014-01-01

We describe the development and implementation of a randomized controlled trial to investigate the impact of genomic counseling on a cohort of patients with heart failure (HF) or hypertension (HTN), managed at a large academic medical center, the Ohio State University Wexner Medical Center (OSUWMC). Our study is built upon the existing Coriell Personalized Medicine Collaborative (CPMC®). OSUWMC patient participants with chronic disease (CD) receive eight actionable complex disease and one pharmacogenomic test report through the CPMC® web portal. Participants are randomized to either the in-person post-test genomic counseling—active arm, versus web-based only return of results—control arm. Study-specific surveys measure: (1) change in risk perception; (2) knowledge retention; (3) perceived personal control; (4) health behavior change; and, for the active arm (5), overall satisfaction with genomic counseling. This ongoing partnership has spurred creation of both infrastructure and procedures necessary for the implementation of genomics and genomic counseling in clinical care and clinical research. This included creation of a comprehensive informed consent document and processes for prospective return of actionable results for multiple complex diseases and pharmacogenomics (PGx) through a web portal, and integration of genomic data files and clinical decision support into an EPIC-based electronic medical record. We present this partnership, the infrastructure, genomic counseling approach, and the challenges that arose in the design and conduct of this ongoing trial to inform subsequent collaborative efforts and best genomic counseling practices. PMID:24926413

Perceived Barriers to Clinic Appointments for Adolescents with Sickle Cell Disease

PubMed Central

Crosby, Lori E.; Modi, Avani C.; Lemanek, Kathleen L.; Guilfoyle, Shanna M.; Kalinyak, Karen A.; Mitchell, Monica J.

2009-01-01

Purpose The purpose of the study was to examine perceived barriers to clinic attendance and strategies to overcome these barriers for adolescents with sickle cell disease (SCD). Materials and Methods This was a two-phased study which utilized focus groups (n = 13) and individual semi-structured interviews (n = 32) with adolescent patients (aged 13–21 years) from three pediatric sickle cell clinics in the Mid-west. Results Adolescents identified competing activities, health status, patient-provider relationships, adverse clinic experiences, and forgetting as barriers to clinic attendance. Calendars/reminders and parent reminders were the most commonly reported strategies to facilitate clinic attendance. Adolescents also reported the need for flexible scheduling and improved patient-provider communication. Discussion Adolescents with SCD and their families may benefit from on-going education about the importance of attending routine clinic visits. Adherence to clinic appointments for adolescents may be enhanced by developing interventions to decrease forgetting (e.g., phone call reminders, text-messaging) and increase patient satisfaction with clinic visits. Scheduling appointments to accommodate busy schedules/scheduling conflicts (e.g., late clinic hours), providing teen-friendly clinic environments and utilizing technology may also facilitate attendance. PMID:19636266

Advances in the management of dyslipidemia.

PubMed

Kampangkaew, June; Pickett, Stephen; Nambi, Vijay

2017-07-01

Cardiovascular disease is the leading cause of morbidity and mortality in the United States and therapies aimed at lipid modification are important for the reduction of cardiovascular risk. There have been many exciting advances in lipid management over the recent years. This review discusses these recent advances as well as the direction of future studies. Several recent clinical trials support low-density lipoprotein cholesterol (LDL-c) reduction beyond maximal statin therapy for improved cardiovascular outcomes. Ezetimibe reduced LDL-c beyond maximal statin therapy and was associated with improved cardiovascular outcomes for high-risk populations. Further LDL-c reduction may also be achieved with proprotein convertase subtilisin/kexin type-9 (PCSK9) inhibition and a recent trial, Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER), was the first to show reduction in cardiovascular events for evolocumab. Additional outcome studies of monoclonal antibody and RNA-targeted PCSK9 inhibitors are underway. Quantitative high-density lipoprotein cholesterol (HDL-c) improvements have failed to have clinical impact to date; most recently, cholesteryl ester transfer protein inhibitors and apolipoprotein infusions have demonstrated disappointing results. There are still ongoing trials in both of these areas, but some newer therapies are focusing on HDL functionality and not just the absolute HDL-c levels. There are several ongoing studies in triglyceride reduction including fatty acid therapy, inhibition of apolipoprotein C-3 or ANGTPL3 and peroxisome proliferator-activated receptor-α agonists. Lipid management continues to evolve and these advances have the potential to change clinical practice in the coming years.

Perspective: Update on Idiopathic Intracranial Hypertension

PubMed Central

Bruce, Beau B.; Biousse, Valérie; Newman, Nancy J.

2011-01-01

Purpose Provide an update on various features of idiopathic intracranial hypertension. Design Perspective. Methods Selected articles on the epidemiology, clinical and imaging features, natural history, pathophysiology, and treatment of idiopathic intracranial hypertension were reviewed and interpreted in the context of the authors’ clinical and research experience. Results Idiopathic intracranial hypertension is primarily a disease of obese women of childbearing age, but it can affect patients of any weight, sex, and age. Although a relatively rare disorder, idiopathic intracranial hypertension’s associated costs in the U.S. entail hundreds of millions of dollars. Even following treatment, headaches are frequently persistent and may require the continued involvement of a neurologist. Quality of life reductions and depression are common among idiopathic intracranial hypertension patients. However, visual dysfunction, especially visual field abnormalities, represents the major morbidity of this disorder, and serial automated perimetry remains the primary mode of patient monitoring. Patients who are men, black, very obese, or anemic are at higher risk of visual loss. Vitamin A metabolism, adipose tissue as an actively secreting endocrine tissue, and cerebral venous abnormalities are areas of active study regarding idiopathic intracranial hypertension’s pathophysiology. Treatment studies show that lumbar puncture is a valuable treatment (in addition to its crucial diagnostic role) and that weight management is critical. However, open questions remain regarding the efficacy of acetazolamide, CSF diversion procedures, and cerebral venous stenting. Conclusions Many questions remain unanswered about idiopathic intracranial hypertension. Ongoing studies, especially an ongoing NIH-funded clinical trial of acetazolamide, should provide more insight into this important, yet poorly understood syndrome of isolated intracranial hypertension. PMID:21696699

Estrogen supplementation to progesterone as luteal phase support in patients undergoing in vitro fertilization: systematic review and meta-analysis.

PubMed

Zhang, Xiao-Mei; Lv, Fang; Wang, Pin; Huang, Xia-Man; Liu, Kai-Feng; Pan, Yu; Dong, Nai-Jun; Ji, Yu-Rong; She, Hong; Hu, Rong

2015-02-01

Meta-analyses have found conflicting results with respect to the use of progesterone or progesterone plus estrogen as luteal phase support for in vitro fertilization (IVF) protocols involving gonadotropins and/or gonadotropin-releasing hormone analogs. The aim of the present study was to perform an updated meta-analysis on the efficacy of progesterone versus progesterone plus estrogen as luteal phase support. We searched the MEDLINE, Cochrane Library, and Google Scholar databases (up to March 18, 2014). The search terms were (estrogen OR estradiol OR oestradiol) AND (progesterone) AND (IVF OR in vitro fertilization) AND (randomized OR prospective). We did not limit the form of estrogen and included subjects who contributed more than 1 cycle to a study. The primary outcome was clinical pregnancy rate. Secondary outcomes were ongoing pregnancy rate, fertilization rate, implantation rate, and miscarriage rate. A total of 11 articles were included in the present analysis, with variable numbers of studies assessing each outcome measure. Results of statistical analyses indicated that progesterone plus estrogen treatment was more likely to result in clinical pregnancy than progesterone alone (pooled odds ratio 1.617, 95% confidence interval 1.059-2.471; P = 0.026). No significant difference between the 2 treatment regimens was found for the other outcome measures. Progesterone plus estrogen for luteal phase support is associated with a higher clinical pregnancy rate than progesterone alone in women undergoing IVF, but other outcomes such as ongoing pregnancy rate, fertilization rate, implantation rate, and miscarriage rate are the same for both treatments.

Examining occupational therapy education through faculty engagement in curriculum mapping and pedagogical reflection.

PubMed

MacNeil, Cheryl; Hand, Theresa

2014-01-01

This article discusses a 1-yr evaluation study of a master of science in occupational therapy program to examine curriculum content and pedagogical practices as a way to gauge program preparedness to move to a clinical doctorate. Faculty members participated in a multitiered qualitative study that included curriculum mapping, semistructured individual interviewing, and iterative group analysis. Findings indicate that curriculum mapping and authentic dialogue helped the program formulate a more streamlined and integrated curriculum with increased faculty collaboration. Curriculum mapping and collaborative pedagogical reflection are valuable evaluation strategies for examining preparedness to offer a clinical doctorate, enhancing a self-study process, and providing information for ongoing formative curriculum review. Copyright © 2014 by the American Occupational Therapy Association, Inc.

Adaptive clinical trial design.

PubMed

Chow, Shein-Chung

2014-01-01

In recent years, the use of adaptive design methods in clinical trials based on accumulated data at interim has received much attention because of its flexibility and efficiency in pharmaceutical/clinical development. In practice, adaptive design may provide the investigators a second chance to modify or redesign the trial while the study is still ongoing. However, it is a concern that a shift in target patient population may occur after significant adaptations are made. In addition, the overall type I error rate may not be preserved. Moreover, the results may not be reliable and hence are difficult to interpret. As indicated by the US Food and Drug Administration draft guidance on adaptive design clinical trials, the adaptive design has to be a prospectively planned opportunity and should be based on information collected within the study, with or without formal statistical hypothesis testing. This article reviews the relative advantages, limitations, and feasibility of commonly considered adaptive designs in clinical trials. Statistical concerns when implementing adaptive designs are also discussed.

Application of seminal plasma to female genital tract prior to embryo transfer in assisted reproductive technology cycles (IVF, ICSI and frozen embryo transfer).

PubMed

Ata, Baris; Abou-Setta, Ahmed M; Seyhan, Ayse; Buckett, William

2018-02-28

The female genital tract is not exposed to seminal plasma during standard assisted reproductive technology (ART) cycles. However, it is thought that the inflammatory reaction triggered by seminal plasma may be beneficial by inducing maternal tolerance to paternal antigens expressed by the products of conception, and may increase the chance of successful implantation and live birth. To assess the effectiveness and safety of application of seminal plasma to the female genital tract prior to embryo transfer in ART cycles. We searched the following databases from inception to October 2017: Cochrane Gynaecology and Fertility Group Specialised Register of Controlled Trials, Cochrane Central Register of Studies Online (CRSO), MEDLINE, Embase, CINAHL and PsycINFO. We also searched trial registers for ongoing trials, including International Clinical Trials Registry Platform (ICTRP) Search Portal and ClinicalTrials.gov. Other sources searched were; Web of Knowledge, OpenGrey, LILACS, PubMed, Google Scholar and the reference lists of relevant articles. We included randomised controlled trials (RCTs) conducted among women undergoing ART, comparing any procedure that would expose the female genital tract to seminal plasma during the period starting five days before embryo transfer and ending two days after it versus no seminal plasma application. Two review authors independently selected trials, assessed risk of bias, and extracted data. We pooled data to calculate relative risks (RRs) and 95% confidence intervals (CIs). We assessed statistical heterogeneity using the I 2 statistic. We assessed the overall quality of the evidence for the main outcomes using GRADE methods. Our primary outcomes were live birth rate and miscarriage rate. Secondary outcomes were live birth/ongoing pregnancy rate, clinical pregnancy rate, multiple pregnancy rate, ectopic pregnancy rate and the incidence of other adverse events. We included 11 RCTs (3215 women). The quality of the evidence ranged from very low to low. The main limitations were risk of bias (associated with poor reporting of allocation concealment and other methods) and imprecision for the primary outcome of live birth rate.Live birth rates: There was insufficient evidence to determine whether there was a difference between the groups with respect to live birth rates (RR 1.10, 95% CI 0.86 to 1.43; participants = 948; studies = 3; I 2 = 0%). Low quality evidence suggests that if the live birth rate following standard ART is 19% it will be between 16% and 27% with seminal plasma application.Miscarriage rate: There was insufficient evidence to determine whether there was a difference between the groups (RR 1.01, 95% CI 0.57 to 1.79; participants = 1209; studies = 4; I 2 = 0%). Low quality evidence suggests that if the miscarriage rate following standard ART is 3.7%, the miscarriage rate following seminal plasma application will be between 2.1% and 6.6%.Live birth or ongoing pregnancy rates: Seminal plasma application makes little or no difference in live birth or ongoing pregnancy rates (RR 1.19, 95% CI 0.95 to 1.49; participants = 1178; studies = 4; I 2 = 4%, low quality evidence). The evidence suggests that if the live birth or ongoing pregnancy rate following standard ART is 19.5% it will be between 18.5% and 29% with seminal plasma application.Clinical pregnancy rates: Seminal plasma application may increase clinical pregnancy rates (RR 1.15, 95% CI 1.01 to 1.31; participants = 2768; studies = 10; I 2 = 0%). Very low quality evidence suggests that if the clinical pregnancy rate following standard ART is 22.0% it will be between 22.2% and 28.8% with seminal plasma application. This finding should be regarded with caution, as a post-hoc sensitivity analysis restricted to studies at overall low risk of bias did not find a significant difference between the groups (RR 1.06, 95% CI 0.81 to 1.39; participants = 547; studies = 3; I 2 = 0%).Multiple pregnancy rate: Seminal plasma application may make little or no difference to multiple pregnancy rates (RR 1.11, 95% CI 0.76 to 1.64; participants = 1642; studies = 5; I 2 = 9%). Low quality evidence suggests that if the multiple pregnancy rate following standard ART is 7%, the multiple pregnancy rate following seminal plasma application will be between 5% and 11.4%.Ectopic pregnancy: There was insufficient evidence to determine whether seminal plasma application influences the risk of ectopic pregnancy (RR 1.59, 95% CI 0.20 to 12.78, participants =1521; studies = 5; I 2 = 0%) .Infectious complications or other adverse events: No data were available on these outcomes AUTHORS' CONCLUSIONS: In women undergoing ART, there was insufficient evidence to determine whether there was a difference between the seminal plasma and the standard ART group in rates of live birth (low-quality evidence) or miscarriage (low quality evidence). There was low quality evidence suggesting little or no difference between the groups in rates of live birth or ongoing pregnancy (composite outcome). We found low quality evidence that seminal plasma application may be associated with more clinical pregnancies than standard ART. There was low quality evidence suggesting little or no difference between the groups in rates of multiple pregnancy. There was insufficient evidence to reach any conclusions about the risk of ectopic pregnancy, and no data were available on infectious complications or other adverse events.We conclude that seminal plasma application is worth further investigation, focusing on live birth and miscarriage rates.

Factors influencing nurses' decision-making process on leaving in the peripheral intravascular catheter after 96 hours: a longitudinal study.

PubMed

Palese, Alvisa; Cassone, Andrea; Kulla, Annamaria; Dorigo, Sabrina; Magee, Jesse; Artico, Marco; Camero, Francesco; Cassin, Catia; Cialdella, Sandra; Floridia, Giuseppe; Nadlišek, Boris; Palcic, Annamaria; Valle, Giulia; Sclauzero, Paola

2011-01-01

The clinical and research debate on the peripheral intravascular (PIV) catheter length of stay in situ is ongoing. The principal aim of this study was to explore the factors behind a nurse's decision to leave a PIV in place for more than 96 hours. The study focused on 7 northern Italian hospitals in 2009. A consequent sample of 269 PIV catheters was included. Direct observation and interviews were adopted. The time of the expected PIV replacement was fixed at 96 hours after its positioning, in accordance with the international guideline. Several factors were taken into account in regard to replacement of the PIV catheters by nurses, ranging from analysis based on their own clinical experience with PIV complications and analysis of the patient's clinical situation to the critical analysis of their own work situation. This clinical decision-making process is valuable: leaving the PIV in place for more than 96 hours is a complex decision and not simply a guideline violation.

Challenges in preparing and implementing a clinical trial at field level in an Ebola emergency: A case study in Guinea, West Africa.

PubMed

Carazo Perez, Sara; Folkesson, Elin; Anglaret, Xavier; Beavogui, Abdoul-Habib; Berbain, Emmanuel; Camara, Alseny-Modet; Depoortere, Evelyn; Lefevre, Annabelle; Maes, Piet; Malme, Kristian Nødtvedt; Malvy, Jean-Marie Denis; Ombelet, Sien; Poelaert, Geertrui; Sissoko, Daouda; Tounkara, Alexis; Trbovic, Pierre; Piguet, Pascal; Antierens, Annick

2017-06-01

During the large Ebola outbreak that affected West Africa in 2014 and 2015, studies were launched to evaluate potential treatments for the disease. A clinical trial to evaluate the effectiveness of the antiviral drug favipiravir was conducted in Guinea. This paper describes the main challenges of the implementation of the trial in the Ebola treatment center of Guéckédou. Following the principles of the Good Clinical Research Practices, we explored the aspects of the community's communication and engagement, ethical conduct, trial protocol compliance, informed consent of participants, ongoing benefit/risk assessment, record keeping, confidentiality of patients and study data, and roles and responsibilities of the actors involved. We concluded that several challenges have to be addressed to successfully implement a clinical trial during an international medical emergency but that the potential for collaboration between research teams and humanitarian organizations needs to be highlighted.

Hypnosis for procedure-related pain and distress in pediatric cancer patients: a systematic review of effectiveness and methodology related to hypnosis interventions.

PubMed

Richardson, Janet; Smith, Joanna E; McCall, Gillian; Pilkington, Karen

2006-01-01

The aim of this study was to systematically review and critically appraise the evidence on the effectiveness of hypnosis for procedure-related pain and distress in pediatric cancer patients. A comprehensive search of major biomedical and specialist complementary and alternative medicine databases was conducted. Citations were included from the databases' inception to March 2005. Efforts were made to identify unpublished and ongoing research. Controlled trials were appraised using predefined criteria. Clinical commentaries were obtained for each study. Seven randomized controlled clinical trials and one controlled clinical trial were found. Studies report positive results, including statistically significant reductions in pain and anxiety/distress, but a number of methodological limitations were identified. Systematic searching and appraisal has demonstrated that hypnosis has potential as a clinically valuable intervention for procedure-related pain and distress in pediatric cancer patients. Further research into the effectiveness and acceptability of hypnosis for pediatric cancer patients is recommended.

Huntington’s Disease Clinical Trials Corner: February 2018

PubMed Central

Rodrigues, Filipe B.; Wild, Edward J.

2018-01-01

In the second edition of the Huntington’s Disease Clinical Trials Corner we list all currently registered and ongoing clinical trials, summarise the top-line results of the recently-announced IONIS-HTTRX trial (NCT02519036), expand on Wave Life Sciences’ PRECISION-HD1 (NCT03225833) and PRECISION-HD2 (NCT03225846), and cover one recently finished trial: the FIRST-HD deutetrabenazine trial (NCT01795859). PMID:29480210

Concurrent ganirelix and follitropin beta therapy is an effective and safe regimen for ovulation induction in women with polycystic ovary syndrome.

PubMed

Elkind-Hirsch, Karen E; Webster, Bobby W; Brown, Crystal P; Vernon, Michael W

2003-03-01

To evaluate controlled ovarian stimulation cycles using the GnRH antagonist ganirelix in combination with the recombinant FSH, follitropin-beta, in women with polycystic ovary syndrome (PCOS). Prospective, nonrandomized clinical study. Hospital-based infertility practice. Twenty women with PCOS planning to undergo ovarian stimulation. Fasting glucose and insulin levels were used to calculate insulin resistance ratios (FG/I). After pretreatment with oral contraceptives, serum LH levels were determined, and 250 microg ganirelix was administered on cycle day 2. Upon suppression of LH, concurrent ganirelix and follitropin-beta therapy (morning ganirelix and evening follitropin-beta) was started and continued until the day of hCG. Days of stimulation, dose of follitropin-beta, pregnancy, and ongoing pregnancy were compared based on FG/I ratios. One dose of ganirelix effectively suppressed LH levels in all patients. All patients ovulated as documented by a rise in progesterone. Significant differences were observed between the insulin-resistant and non-insulin-resistant groups for both days of stimulation and dose of follitropin-beta. The overall clinical pregnancy rate was 44.4%, with an ongoing pregnancy rate of 27.8%. In this preliminary study, we demonstrate the effectiveness of a concurrent ganirelix and follitropin-beta therapy for ovarian stimulation in women with PCOS.

Immunotherapy in Gynecologic Cancers: Are We There Yet?

PubMed

Pakish, Janelle B; Jazaeri, Amir A

2017-08-24

Immune-targeted therapies have demonstrated durable responses in many tumor types with limited treatment options and poor overall prognosis. This has led to enthusiasm for expanding such therapies to other tumor types including gynecologic malignancies. The use of immunotherapy in gynecologic malignancies is in the early stages and is an active area of ongoing clinical research. Both cancer vaccines and immune checkpoint inhibitor therapy continue to be extensively studied in gynecologic malignancies. Immune checkpoint inhibitors, in particular, hold promising potential in specific subsets of endometrial cancer that express microsatellite instability. The key to successful treatment with immunotherapy involves identification of the subgroup of patients that will derive benefit. The number of ongoing trials in cervical, ovarian, and endometrial cancer will help to recognize these patients and make treatment more directed. Additionally, a number of studies are combining immunotherapy with standard treatment options and will help to determine combinations that will enhance responses to standard therapy. Overall, there is much enthusiasm for immunotherapy approaches in gynecologic malignancies. However, the emerging data shows that with the exception of microsatellite unstable tumors, the use of single-agent immune checkpoint inhibitors is associated with response rates of 10-15%. More effective and likely combinatorial approaches are needed and will be informed by the findings of ongoing trials.

Systematic reviews of therapeutic interventions frequently consider patient-important outcomes.

PubMed

Ameur, Hayet; Ravaud, Philippe; Fayard, Florence; Riveros, Carolina; Dechartres, Agnes

2017-04-01

To determine whether recently published and ongoing systematic reviews of therapeutic interventions assess patient-important outcomes. For this methodological review, we searched MEDLINE via PubMed for recently published systematic reviews and online registry of systematic reviews (PROSPERO) for ongoing systematic reviews. We selected systematic reviews with meta-analyses of randomized controlled trials. We extracted all outcomes defined in the methods section and categorized them. Mortality, other clinical events, pain, quality of life, function, and therapeutic decisions were considered patient-important outcomes. We included 420 systematic reviews: 90 Cochrane reviews, 200 other published reviews, and 130 registered ongoing reviews. Primary outcomes were defined in 85 Cochrane reviews (95%), 98 (49%) other published reviews and all ongoing reviews. At least one patient-important outcome was defined as a primary outcome in 81/85 Cochrane reviews (95%), 78/98 other published reviews (80%), and 117/130 ongoing reviews (90%). Considering all outcomes assessed, at least one patient-important outcome was evaluated in 90/90 Cochrane reviews (100%), 189/200 other published reviews (95%), and 121/130 ongoing reviews (93%). Most recent systematic reviews aim to assess patient-important outcomes, which contrasts with RCTs. These results suggest some important gaps between primary and secondary research. Copyright © 2017 Elsevier Inc. All rights reserved.

Closing the quality gap: revisiting the state of the science (vol. 2: the patient-centered medical home).

PubMed Central

Williams, John W; Jackson, George L; Powers, Benjamin J; Chatterjee, Ranee; Bettger, Janet Prvu; Kemper, Alex R; Hasselblad, Vic; Dolor, Rowena J; Irvine, R Julian; Heidenfelder, Brooke L; Kendrick, Amy S; Gray, Rebecca

2012-01-01

OBJECTIVES As part of the Closing the Quality Gap: Revisiting the State of the Science series of the Agency for Healthcare Research and Quality (AHRQ), this systematic review sought to identify completed and ongoing evaluations of the comprehensive patient-centered medical home (PCMH), summarize current evidence for this model, and identify evidence gaps. DATA SOURCES We searched PubMed®, CINAHL®, and the Cochrane Database of Systematic Reviews for published English-language studies, and a wide variety of databases and Web resources to identify ongoing or recently completed studies. REVIEW METHODS Two investigators per study screened abstracts and full-text articles for inclusion, abstracted data, and performed quality ratings and evidence grading. Our functional definition of PCMH was based on the definition used by AHRQ. We included studies that explicitly claimed to be evaluating PCMH and those that did not but which met our functional definition. RESULTS Seventeen studies with comparison groups evaluated the effects of PCMH (Key Question [KQ] 1). Older adults in the United States were the most commonly studied population (8 of 17 studies). PCMH interventions had a small positive impact on patient experiences (including patient-perceived care coordination) and small to moderate positive effects on preventive care services (moderate strength of evidence [SOE]). Staff experiences were also improved by a small to moderate degree (low SOE). There were too few studies to estimate effects on clinical or most economic outcomes. Twenty-one of 27 studies reported approaches that addressed all 7 major PCMH components (KQ 2), including team-based care, sustained partnership, reorganized care or structural changes to care, enhanced access, coordinated care, comprehensive care, and a systems-based approach to quality. A total of 51 strategies were used to address the 7 major PCMH components. Twenty-two of 27 studies reported information on financial systems used to implement PCMH, implementation strategies, and/or organizational learning strategies for implementing PCMH (KQ 3). The 31 studies identified in the horizon scan of ongoing PCMH studies (KQ 4) were broadly representative of the U.S. health care system, both in geography and in the complexity of private and public health care payers and delivery networks. CONCLUSIONS Published studies of PCMH interventions often have similar broad elements, but precise components of care varied widely. The PCMH holds promise for improving the experiences of patients and staff, and potentially for improving care processes. However, current evidence is insufficient to determine effects on clinical and most economic outcomes. Ongoing studies identified through the horizon scan have potential to greatly expand the evidence base relating to PCMH. PMID:24422946

The impact of clinical nurse specialists on clinical pathways in the application of evidence-based practice.

PubMed

Gurzick, Martha; Kesten, Karen S

2010-01-01

The purpose of this article was to address the call for evidence-based practice through the development of clinical pathways and to assert the role of the clinical nurse specialist (CNS) as a champion in clinical pathway implementation. In the current health care system, providing quality of care while maintaining cost-effectiveness is an ever-growing battle that institutions face. The CNS's role is central to meeting these demands. An extensive literature review has been conducted to validate the use of clinical pathways as a means of improving patient outcomes. This literature also suggests that clinical pathways must be developed, implemented, and evaluated utilizing validated methods including the use of best practice standards. Execution of clinical pathways should include a clinical expert, who has the ability to look at the system as a whole and can facilitate learning and change by employing a multitude of competencies while maintaining a sphere of influence over patient and families, nurses, and the system. The CNS plays a pivotal role in influencing effective clinical pathway development, implementation, utilization, and ongoing evaluation to ensure improved patient outcomes and reduced costs. This article expands upon the call for evidence-based practice through the utilization of clinical pathways to improve patient outcomes and reduce costs and stresses the importance of the CNS as a primary figure for ensuring proper pathway development, implementation, and ongoing evaluation. Copyright 2010 Elsevier Inc. All rights reserved.

Current transcatheter devices to treat functional tricuspid regurgitation with discussion of issues relevant to clinical trial design

PubMed Central

2017-01-01

Functional or secondary tricuspid regurgitation (TR) has seen increased attention in recent times as relationships with clinically-relevant outcomes have come to light. Despite the association of increased mortality with significant TR, the disease remains under-recognized and thus relatively untreated. In addition, the disease itself has not been extensively studied and the interactions between annular dilatation, right heart disease and pulmonary hypertension are poorly understood. However, the high mortality and recurrence rate with current surgical replacement or repair techniques is well recognised, opening the door to transcatheter therapies for functional TR. The current perspective reviews the rationale for transcatheter solutions, describes some of the current approaches and discusses the ongoing questions of a poorly-studied condition which may limit the design of clinical trials for this disease. PMID:28706866

Plasminogen replacement therapy for the treatment of children and adults with congenital plasminogen deficiency

PubMed Central

Nakar, Charles; Parker, Joseph M.; Albert, Gary R.; Moran, John E.; Thibaudeau, Karen; Thukral, Neelam; Hardesty, Brandon M.; Laurin, Pierre; Sandset, Per Morten

2018-01-01

Congenital plasminogen deficiency is caused by mutations in PLG, the gene coding for production of the zymogen plasminogen, and is an ultrarare disorder associated with abnormal accumulation or growth of fibrin-rich pseudomembranous lesions on mucous membranes. Left untreated, these lesions may impair organ function and impact quality of life. Plasminogen replacement therapy should provide an effective treatment of the manifestations of congenital plasminogen deficiency. An open-label phase 2/3 study of human Glu-plasminogen administered IV at 6.6 mg/kg every 2 to 4 days in 15 patients with congenital plasminogen deficiency is ongoing. Reported here are data on 14 patients who completed at least 12 weeks of treatment. The primary end point was an increase in trough plasminogen activity levels by at least an absolute 10% above baseline. The secondary end point was clinical success, defined as ≥50% improvement in lesion number/size or functionality impact from baseline. All patients achieved at least an absolute 10% increase in trough plasminogen activity above baseline. Clinical success was observed in all patients with clinically visible (conjunctiva and gingiva), nonvisible (nasopharynx, bronchus, colon, kidney, cervix, and vagina), and wound-healing manifestations of the disease. Therapeutic effects were rapid, as all but 2 lesions resolved or improved after 4 weeks of treatment. Human Glu-plasminogen was well tolerated in both children and adults. This study provides critical first evidence of the clinical utility of ongoing replacement therapy with human Glu-plasminogen for the treatment of children and adults with congenital plasminogen deficiency. This trial was registered at www.clinicaltrials.gov as #NCT02690714. PMID:29321155

Investigating methotrexate toxicity within a randomized double-blinded, placebo-controlled trial: Rationale and design of the Cardiovascular Inflammation Reduction Trial-Adverse Events (CIRT-AE) Study.

PubMed

Sparks, Jeffrey A; Barbhaiya, Medha; Karlson, Elizabeth W; Ritter, Susan Y; Raychaudhuri, Soumya; Corrigan, Cassandra C; Lu, Fengxin; Selhub, Jacob; Chasman, Daniel I; Paynter, Nina P; Ridker, Paul M; Solomon, Daniel H

2017-08-01

The role of low dose methotrexate (LDM) in potential serious toxicities remains unclear despite its common use. Prior observational studies investigating LDM toxicity compared LDM to other active drugs. Prior placebo-controlled clinical trials of LDM in inflammatory conditions were not large enough to investigate toxicity. The Cardiovascular Inflammation Reduction Trial (CIRT) is an ongoing NIH-funded, randomized, double-blind, placebo-controlled trial of LDM in the secondary prevention of cardiovascular disease. We describe here the rationale and design of the CIRT-Adverse Events (CIRT-AE) ancillary study which aims to investigate adverse events within CIRT. CIRT will randomize up to 7000 participants with cardiovascular disease and no systemic rheumatic disease to either LDM (target dose: 15-20mg/week) or placebo for an average follow-up period of 3-5 years; subjects in both treatment arms receive folic acid 1mg daily for 6 days each week. The primary endpoints of CIRT include recurrent cardio vascular events, incident diabetes, and all-cause mortality, and the ancillary CIRT-AE study has been designed to adjudicate other clinically important adverse events including hepatic, gastrointestinal, respiratory, hematologic, infectious, mucocutaneous, oncologic, renal, neurologic, and musculoskeletal outcomes. Methotrexate polyglutamate levels and genome-wide single nucleotide polymorphisms will be examined for association with adverse events. CIRT-AE will comprehensively evaluate potential LDM toxicities among subjects with cardiovascular disease within the context of a large, ongoing, double-blind, placebo-controlled trial. This information may lead to a personalized approach to monitoring LDM in clinical practice. Copyright © 2017 Elsevier Inc. All rights reserved.

Ongoing measles outbreak in Wallonia, Belgium, December 2016 to March 2017: characteristics and challenges

PubMed Central

Grammens, Tine; Schirvel, Carole; Leenen, Sylvie; Shodu, Nathalie; Hutse, Veronik; Mendes da Costa, Elise; Sabbe, Martine

2017-01-01

We describe characteristics of an ongoing measles outbreak in Wallonia, Belgium, and difficulties in control measures implementation. As at 12 March 2017, 177 measles cases were notified, of which 50% were 15 years and older, 49% female. Atypical clinical presentation and severe complications, mainly among adults, in combination with late notification, low or unknown vaccination coverage of contacts, infected healthcare workers and increased workload due to contact tracing, are the main concerns for outbreak management. PMID:28488998

The impact of short term clinical placement in a developing country on nursing students: A qualitative descriptive study.

PubMed

Ulvund, Ingeborg; Mordal, Elin

2017-08-01

Offering nursing students' international clinical placement during the educational program is one response to meet the need of cultural competence among nurses. This paper provides insight into the impact of clinical placement, in a developing country, on third year nursing students. In the study we investigated how short term international clinical placement impacted Norwegian nursing students' development of cultural competency. In this study we utilised a qualitative descriptive design and used individual interviews with eighteen Norwegian nursing students who had all participated in an international clinical placement. The data were analysed using the principles of systematic text condensation. In spite the international clinical placement only was four weeks, the findings suggested that real life experience culturally awakened the students and forced an ongoing process developing cultural competence. However, it is important to give students time to reflection. Although increased cultural awareness and a growing cultural competence was identified by the students undertaking international clinical placement, further research is required. It is important to investigate the best methods to support the students' reflection such that the experiences lead to learning. Copyright © 2017 Elsevier Ltd. All rights reserved.

Netupitant and Palonosetron Hydrochloride

Cancer.gov

This page contains brief information about netupitant and palonosetron hydrochloride and a collection of links to more information about the use of this combination drug, research results, and ongoing clinical trials.

Trifluridine and Tipiracil Hydrochloride

Cancer.gov

This page contains brief information about trifluridine and tipiracil hydrochloride and a collection of links to more information about the use of this combination drug, research results, and ongoing clinical trials.

Individualised gonadotropin dose selection using markers of ovarian reserve for women undergoing in vitro fertilisation plus intracytoplasmic sperm injection (IVF/ICSI).

PubMed

Lensen, Sarah F; Wilkinson, Jack; Leijdekkers, Jori A; La Marca, Antonio; Mol, Ben Willem J; Marjoribanks, Jane; Torrance, Helen; Broekmans, Frank J

2018-02-01

During a cycle of in vitro fertilisation plus intracytoplasmic sperm injection (IVF/ICSI), women receive daily doses of gonadotropin follicle-stimulating hormone (FSH) to induce multifollicular development in the ovaries. Generally, the dose of FSH is associated with the number of eggs retrieved. A normal response to stimulation is often considered desirable, for example the retrieval of 5 to 15 oocytes. Both poor and hyper-response are associated with increased chance of cycle cancellation. Hyper-response is also associated with increased risk of ovarian hyperstimulation syndrome (OHSS). Clinicians often individualise the FSH dose using patient characteristics predictive of ovarian response such as age. More recently, clinicians have begun using ovarian reserve tests (ORTs) to predict ovarian response based on the measurement of various biomarkers, including basal FSH (bFSH), antral follicle count (AFC), and anti-Müllerian hormone (AMH). It is unclear whether individualising FSH dose based on these markers improves clinical outcomes. To assess the effects of individualised gonadotropin dose selection using markers of ovarian reserve in women undergoing IVF/ICSI. We searched the Cochrane Gynaecology and Fertility Group Specialised Register, Cochrane Central Register of Studies Online, MEDLINE, Embase, CINAHL, LILACS, DARE, ISI Web of Knowledge, ClinicalTrials.gov, and the World Health Organisation International Trials Registry Platform search portal from inception to 27th July 2017. We checked the reference lists of relevant reviews and included studies. We included trials that compared different doses of FSH in women with a defined ORT profile (i.e. predicted low, normal or high responders based on AMH, AFC, and/or bFSH) and trials that compared an individualised dosing strategy (based on at least one ORT measure) versus uniform dosing or a different individualised dosing algorithm. We used standard methodological procedures recommended by Cochrane. Primary outcomes were live birth/ongoing pregnancy and severe OHSS. Secondary outcomes included clinical pregnancy, moderate or severe OHSS, multiple pregnancy, oocyte yield, cycle cancellations, and total dose and duration of FSH administration. We included 20 trials (N = 6088); however, we treated those trials with multiple comparisons as separate trials for the purpose of this review. Meta-analysis was limited due to clinical heterogeneity. Evidence quality ranged from very low to moderate. The main limitations were imprecision and risk of bias associated with lack of blinding.Direct dose comparisons in women according to predicted responseAll evidence was low or very low quality.Due to differences in dose comparisons, caution is warranted in interpreting the findings of five small trials assessing predicted low responders. The effect estimates were very imprecise, and increased FSH dosing may or may not have an impact on rates of live birth/ongoing pregnancy, OHSS, and clinical pregnancy.Similarly, in predicted normal responders (nine studies, three comparisons), higher doses may or may not impact the probability of live birth/ongoing pregnancy (e.g. 200 versus 100 international units: OR 0.88, 95% CI 0.57 to 1.36; N = 522; 2 studies; I 2 = 0%) or clinical pregnancy. Results were imprecise, and a small benefit or harm remains possible. There were too few events for the outcome of OHSS to enable any inferences.In predicted high responders, lower doses may or may not have an impact on rates of live birth/ongoing pregnancy (OR 0.98, 95% CI 0.66 to 1.46; N = 521; 1 study), OHSS, and clinical pregnancy. However, lower doses probably reduce the likelihood of moderate or severe OHSS (Peto OR 2.31, 95% CI 0.80 to 6.67; N = 521; 1 study).ORT-algorithm studiesFour trials compared an ORT-based algorithm to a non-ORT control group. Rates of live birth/ongoing pregnancy and clinical pregnancy did not appear to differ by more than a few percentage points (respectively: OR 1.04, 95% CI 0.88 to 1.23; N = 2823, 4 studies; I 2 = 34%; OR 0.96, 95% CI 0.82 to 1.13, 4 studies, I 2 =0%, moderate-quality evidence). However, ORT algorithms probably reduce the likelihood of moderate or severe OHSS (Peto OR 0.58, 95% CI 0.34 to 1.00; N = 2823; 4 studies; I 2 = 0%, low quality evidence). There was insufficient evidence to determine whether the groups differed in rates of severe OHSS (Peto OR 0.54, 95% CI 0.14 to 1.99; N = 1494; 3 studies; I 2 = 0%, low quality evidence). Our findings suggest that if the chance of live birth with a standard dose is 26%, the chance with ORT-based dosing would be between 24% and 30%. If the chance of moderate or severe OHSS with a standard dose is 2.5%, the chance with ORT-based dosing would be between 0.8% and 2.5%. These results should be treated cautiously due to heterogeneity in the study designs. We did not find that tailoring the FSH dose in any particular ORT population (low, normal, high ORT), influenced rates of live birth/ongoing pregnancy but we could not rule out differences, due to sample size limitations. In predicted high responders, lower doses of FSH seemed to reduce the overall incidence of moderate and severe OHSS. Moderate-quality evidence suggests that ORT-based individualisation produces similar live birth/ongoing pregnancy rates to a policy of giving all women 150 IU. However, in all cases the confidence intervals are consistent with an increase or decrease in the rate of around five percentage points with ORT-based dosing (e.g. from 25% to 20% or 30%). Although small, a difference of this magnitude could be important to many women. Further, ORT algorithms reduced the incidence of OHSS compared to standard dosing of 150 IU, probably by facilitating dose reductions in women with a predicted high response. However, the size of the effect is unclear. The included studies were heterogeneous in design, which limited the interpretation of pooled estimates, and many of the included studies had a serious risk of bias.Current evidence does not provide a clear justification for adjusting the standard dose of 150 IU in the case of poor or normal responders, especially as increased dose is generally associated with greater total FSH dose and therefore greater cost. However, a decreased dose in predicted high responders may reduce OHSS.

Diabetes in pregnancy outcomes: a systematic review and proposed codification of definitions.

PubMed

Feig, Denice S; Corcoy, Rosa; Jensen, Dorte Moller; Kautzky-Willer, Alexandra; Nolan, Christopher J; Oats, Jeremy J N; Sacks, David A; Caimari, Francisca; McIntyre, H David

2015-10-01

Rising rates of diabetes in pregnancy have led to an escalation in research in this area. As in any area of clinical research, definitions of outcomes vary from study to study, making it difficult to compare research findings and draw conclusions. Our aim was to compile and create a repository of definitions, which could then be used universally. A systematic review of the literature was performed on published and ongoing randomized controlled trials in the area of diabetes in pregnancy between 01 Jan 2000 and 01 Jun 2012. Other sources included the World Health Organization and Academic Society Statements. The advice of experts was sought when appropriate definitions were lacking. Among the published randomized controlled trials on diabetes and pregnancy, 171 abstracts were retrieved, 64 full texts were reviewed and 53 were included. Among the ongoing randomized controlled trials published in ClinicalTrials.gov, 90 protocols were retrieved and 25 were finally included. The definitions from these were assembled and the final maternal definitions and foetal definitions were agreed upon by consensus. It is our hope that the definitions we have provided (i) will be widely used in the reporting of future studies in the area of diabetes in pregnancy, that they will (ii) facilitate future systematic reviews and formal meta analyses and (iii) ultimately improve outcomes for mothers and babies. Copyright © 2015 John Wiley & Sons, Ltd.

Changes in the costs of treating mental health disorders: an overview of recent research findings.

PubMed

Berndt, Ernst R

2004-01-01

This article reviews recent evidence on changes over time in the direct medical costs of treating three of the more common mental health disorders in the US: the acute (16-week) phase of major depressive disorder, the ongoing treatment of schizophrenia, and the ongoing treatment of bipolar I disorders. The three studies discussed in this article cover various time intervals over the decade from 1991 through 2000, and encompass both private sector and governmental funding sources. Although there has been a shift over time away from intensive psychosocial/psychotherapy and towards increasingly expensive psychopharmacotherapy for all three disorders, total direct medical costs of treatment for each of these three mental health disorders have been declining over time. However, a substantial portion of treatment is not supported by clinical evidence.

Bruton tyrosine kinase inhibitors: a promising novel targeted treatment for B cell lymphomas

PubMed Central

Aalipour, Amin; Advani, Ranjana H.

2015-01-01

Summary Constitutive or aberrant signalling of the B cell receptor signalling cascade has been implicated in the propagation and maintenance of a variety of B cell malignancies. Small molecule inhibitors of Bruton tyrosine kinase (BTK), a protein early in this cascade and specifically expressed in B cells, have emerged as a new class of targeted agents. There are several BTK inhibitors, including ONO-WG-307, LFM-A13, dasatinib, CC-292, and PCI-32765 (ibrutinib), in preclinical and/or clinical development of which ibrutinib is currently in phase III trials. Recent clinical data suggest significant activity of ibrutinib as a first in class oral inhibitor of BTK. This review provides an overview of ongoing clinical studies of BTK inhibitors. PMID:24111579

Spirulina in Clinical Practice: Evidence-Based Human Applications

PubMed Central

Karkos, P. D.; Leong, S. C.; Karkos, C. D.; Sivaji, N.; Assimakopoulos, D. A.

2011-01-01

Spirulina or Arthrospira is a blue-green alga that became famous after it was successfully used by NASA as a dietary supplement for astronauts on space missions. It has the ability to modulate immune functions and exhibits anti-inflammatory properties by inhibiting the release of histamine by mast cells. Multiple studies investigating the efficacy and the potential clinical applications of Spirulina in treating several diseases have been performed and a few randomized controlled trials and systematic reviews suggest that this alga may improve several symptoms and may even have an anticancer, antiviral and antiallergic effects. Current and potential clinical applications, issues of safety, indications, side-effects and levels of evidence are addressed in this review. Areas of ongoing and future research are also discussed. PMID:18955364

Improving Clinical Feedback to Anesthesia Residents by Using an Optical Scanner and a Microcomputer.

ERIC Educational Resources Information Center

Albanese, Mark A.; And Others

1989-01-01

At the University of Iowa problems associated with managing evaluations of anesthesia residents led to a major backlog of unanalyzed evaluation forms. A system developed at the University that enables ongoing feedback to residents and provides a method to assess the clinical competence of residents is described. (Author/MLW)

An Evidence-Based Practice Model across the Academic and Clinical Settings

ERIC Educational Resources Information Center

Wolter, Julie A.; Corbin-Lewis, Kim; Self, Trisha; Elsweiler, Anne

2011-01-01

This tutorial is designed to provide academic communication sciences and disorders (CSD) programs, at both the undergraduate and graduate levels, with a comprehensive instructional model on evidence-based practice (EBP). The model was designed to help students view EBP as an ongoing process needed in all clinical decision making. The three facets…

How do clinicians actually use the Diagnostic and Statistical Manual of Mental Disorders in clinical practice and why we need to know more.

PubMed

First, Michael B; Bhat, Venkat; Adler, David; Dixon, Lisa; Goldman, Beth; Koh, Steve; Levine, Bruce; Oslin, David; Siris, Sam

2014-12-01

The clinical use of the Diagnostic and Statistical Manual of Mental Disorders (DSM) is explicitly stated as a goal for both the DSM Fourth Edition and DSM Fifth Edition (DSM-5) revisions. Many uses assume a relatively faithful application of the DSM diagnostic definitions. However, studies demonstrate significant discrepancies between clinical psychiatric diagnoses with those made using structured interviews suggesting that clinicians do not systematically apply the diagnostic criteria. The limited information regarding how clinicians actually use the DSM raises important questions: a) How can the clinical use be improved without first having a baseline assessment? b) How can potentially significant shifts in practice patterns based on wording changes be assessed without knowing the extent to which the criteria are used as written? Given the American Psychiatric Association's plans for interim revisions to the DSM-5, the value of a detailed exploration of its actual use in clinical practice remains a significant ongoing concern and deserves further study including a number of survey and in vivo studies.

Apolipoprotein B synthesis inhibition: results from clinical trials.

PubMed

Visser, Maartje E; Kastelein, John J P; Stroes, Erik S G

2010-08-01

Mipomersen is a second-generation antisense oligonucleotide developed to inhibit the synthesis of apolipoprotein B-100 in the liver. In this review we will summarize the results of recent preclinical and clinical studies addressing safety and low-density lipoprotein-cholesterol (LDL-c) lowering efficacy of this new compound. In phase 3 clinical trials, mipomersen has been shown to significantly reduce LDL-c in patients with homozygous and heterozygous familial hypercholesterolemia on maximally tolerated lipid-lowering therapy. Injection site reactions, flu-like symptoms and increases in liver transaminases were the main adverse events. A recent safety study, designed to investigate the effects of mipomersen on intrahepatic triglyceride content, failed to show evidence of clinically relevant hepatic steatosis after 13 weeks of treatment. Mipomersen is a new agent to lower LDL-c in patients at increased risk of cardiovascular disease and/or intolerant to statins. Whereas safety concerns have focused on hepatic fat accumulation, to date no evidence of clinically relevant increases of intrahepatic triglyceride content are reported. Ongoing and future studies are eagerly awaited to assess the impact of mipomersen on hepatic triglyceride content after prolonged exposure.

Warfarin Pharmacogenetics

PubMed Central

Johnson, Julie A.; Cavallari, Larisa H.

2014-01-01

The cytochrome P450 (CYP) 2C9 and vitamin K epoxide reductase complex 1 (VKORC1) genotypes have been strongly and consistently associated with warfarin dose requirements, and dosing algorithms incorporating genetic and clinical information have been shown to be predictive of stable warfarin dose. However, clinical trials evaluating genotype-guided warfarin dosing produced mixed results, calling into question the utility of this approach. Recent trials used surrogate markers as endpoints rather than clinical endpoints, further complicating translation of the data to clinical practice. The present data do not support genetic testing to guide warfarin dosing, but in the setting where genotype data are available, use of such data in those of European ancestry is reasonable. Outcomes data are expected from an on-going trial, observational studies continue, and more work is needed to define dosing algorithms that incorporate appropriate variants in minority populations; all these will further shape guidelines and recommendations on the clinical utility of genotype-guided warfarin dosing. PMID:25282448

Daunorubicin Hydrochloride and Cytarabine Liposome

Cancer.gov

This page contains brief information about daunorubicin hydrochloride and cytarabine liposome and a collection of links to more information about the use of this drug, research results, and ongoing clinical trials.

Paclitaxel Albumin-stabilized Nanoparticle Formulation

Cancer.gov

This page contains brief information about paclitaxel albumin-stabilized nanoparticle formulation and a collection of links to more information about the use of this drug, research results, and ongoing clinical trials.

Quantifying the test-retest reliability of cerebral blood flow measurements in a clinical model of on-going post-surgical pain: A study using pseudo-continuous arterial spin labelling.

PubMed

Hodkinson, Duncan J; Krause, Kristina; Khawaja, Nadine; Renton, Tara F; Huggins, John P; Vennart, William; Thacker, Michael A; Mehta, Mitul A; Zelaya, Fernando O; Williams, Steven C R; Howard, Matthew A

2013-01-01

Arterial spin labelling (ASL) is increasingly being applied to study the cerebral response to pain in both experimental human models and patients with persistent pain. Despite its advantages, scanning time and reliability remain important issues in the clinical applicability of ASL. Here we present the test-retest analysis of concurrent pseudo-continuous ASL (pCASL) and visual analogue scale (VAS), in a clinical model of on-going pain following third molar extraction (TME). Using ICC performance measures, we were able to quantify the reliability of the post-surgical pain state and ΔCBF (change in CBF), both at the group and individual case level. Within-subject, the inter- and intra-session reliability of the post-surgical pain state was ranked good-to-excellent (ICC > 0.6) across both pCASL and VAS modalities. The parameter ΔCBF (change in CBF between pre- and post-surgical states) performed reliably (ICC > 0.4), provided that a single baseline condition (or the mean of more than one baseline) was used for subtraction. Between-subjects, the pCASL measurements in the post-surgical pain state and ΔCBF were both characterised as reliable (ICC > 0.4). However, the subjective VAS pain ratings demonstrated a significant contribution of pain state variability, which suggests diminished utility for interindividual comparisons. These analyses indicate that the pCASL imaging technique has considerable potential for the comparison of within- and between-subjects differences associated with pain-induced state changes and baseline differences in regional CBF. They also suggest that differences in baseline perfusion and functional lateralisation characteristics may play an important role in the overall reliability of the estimated changes in CBF. Repeated measures designs have the important advantage that they provide good reliability for comparing condition effects because all sources of variability between subjects are excluded from the experimental error. The ability to elicit reliable neural correlates of on-going pain using quantitative perfusion imaging may help support the conclusions derived from subjective self-report.

Facilitators and barriers to the increased supervisory role of senior charge nurses: a qualitative study.

PubMed

Rankin, J; McGuire, C; Matthews, L; Russell, M; Ray, D

2016-04-01

To explore the experiences of senior charge nurses provided with 'increased supervisory hours'. Designated supervisory time is essential for senior charge nurses to provide effective clinical leadership. It is important to explore the impact arises of such an increase. An online questionnaire collected exploratory data from senior charge nurses (n = 60). Semi-structured interviews gathered in-depth qualitative data (n = 12). Findings were analysed for common themes associated with implementation of the increased senior charge nurse supervisory role. The majority of senior charge nurses were unable to use their full allocation of supervisory time. They struggled to accomplish leadership goals because of managing staffing levels, increased workload, time constraints and limited support. Factors that facilitated the role included preparation and support, adequate staff capacity, effective leadership skills and availability of supervisory time. The senior charge nurses took pride in providing clinical leadership, promoting staff development and delivering patient care. Support, in terms of preparation, capacity building and ongoing mentoring, was a key factor for achieving senior charge nurse goals. Senior charge nurses should be supported to maximise supervisory time through the provision of an induction programme, formal coaching and ongoing training and development. Preparation and support is essential for senior charge nurses to deliver enhanced clinical leadership through increased supervisory time. © 2015 The Authors Journal of Nursing Management Published by John Wiley & Sons Ltd.

KRAS and colorectal cancer: ethical and pragmatic issues in effecting real-time change in oncology clinical trials and practice.

PubMed

Blanke, Charles D; Goldberg, Richard M; Grothey, Axel; Mooney, Margaret; Roach, Nancy; Saltz, Leonard B; Welch, John J; Wood, William A; Meropol, Neal J

2011-01-01

Systemic therapy has led to a median survival time for patients with advanced colorectal cancer (CRC) almost fourfold longer than that expected with best supportive care, an outcome achieved through combining chemotherapeutic and targeted biologic agents. Although the latter can include anti-epidermal growth factor receptor antibodies, such as cetuximab and panitumumab, we now have strong evidence that patients whose tumors harbor mutated KRAS will not benefit from this class of agent. Acceptance of the reliability and importance of the KRAS data took several years to evolve, however, for a variety of reasons. The timeline from the presentation and publication of small, retrospective phase II studies to widespread acceptance of the KRAS predictive value and changes in behavior-specifically, modifications of ongoing national trials in advanced/metastatic CRC, changes in national guidelines and practice patterns, and adjustments to the labeled indications for the monoclonal antibodies-was lengthy. In this commentary, we discuss whether or not the process of data disclosure regarding KRAS status and treatment of advanced CRC patients was effective in permitting timely decisions regarding ongoing publicly funded clinical trials and whether or not such decisions were rational and ethical. The overall goals are to highlight lessons learned regarding early disclosure of clinical trial results, as well as vetting and adoption of new scientific data, and to propose modifications for handling similar situations in the future.

Review of the contemporary cytotoxic and biologic combinations available for the treatment of metastatic breast cancer.

PubMed

Tkaczuk, Katherine H Rak

2009-01-01

Treatment of metastatic breast cancer (MBC) with > or =2 chemotherapeutic agents concurrently has been shown to increase response rates, often at the cost of a substantial increase in toxicity, and with minimal impact on the overall survival. However, some combinations of the newer cytotoxic agents, as well as combinations of chemotherapeutic agents and targeted biologic anticancer agents, can produce synergistic efficacy with a manageable toxicity profile. The aims of this work were to provide an overview of the currently approved combination regimens available for the treatment of MBC and to consider the clinical data supporting other drug combinations that may supplement the current therapeutic choices in the near future. Literature searches were performed using MEDLINE/PubMed, with a focus on combination therapies for the treatment of MBC that are approved by the US Food and Drug Administration (FDA) or in Phase III clinical trials. The National Institutes of Health's Clinical Trial Registry was searched for relevant ongoing clinical trials in specific areas. Bibliographies were also searched for additional relevant material. Preference was given to recently published, larger, well-designed clinical trials that influence current prescribing practices. Phase I and II studies, and/or studies older than 10 years (ie, published earlier than 1999), were afforded less emphasis or were disregarded. Combinations of taxanes with capecitabine or gemcitabine, and ixabepilone plus capecitabine, are approved by the FDA as combination regimens for the treatment of MBC. The use of targeted therapies such as trastuzumab, bevacizumab, or lapatinib in combination with taxanes (for the former two) or capecitabine (for lapatinib) is also approved. Several investigational drug combinations are also currently undergoing evaluation in clinical trials, including combinations of bevacizumab and gemcitabine with capecitabine or alternative taxanes. Although results from Phase I and II studies are largely encouraging so far, the data from ongoing Phase III studies will ultimately dictate changes in clinical practice. It seems unlikely that any single agent or combination regimen will emerge as superior in all patients with MBC, given the heterogeneous nature of the disease and patient population. New combination regimens for MBC may broaden the range of treatment options currently available to delay disease progression for as long as possible. Copyright 2009 Excerpta Medica Inc. All rights reserved.

Bruton's Tyrosine Kinase: From X-Linked Agammaglobulinemia Toward Targeted Therapy for B-Cell Malignancies

PubMed Central

Ponader, Sabine; Burger, Jan A.

2014-01-01

Discovery of Bruton's tyrosine kinase (BTK) mutations as the cause for X-linked agammaglobulinemia was a milestone in understanding the genetic basis of primary immunodeficiencies. Since then, studies have highlighted the critical role of this enzyme in B-cell development and function, and particularly in B-cell receptor signaling. Because its deletion affects mostly B cells, BTK has become an attractive therapeutic target in autoimmune disorders and B-cell malignancies. Ibrutinib (PCI-32765) is the most advanced BTK inhibitor in clinical testing, with ongoing phase III clinical trials in patients with chronic lymphocytic leukemia and mantle-cell lymphoma. In this article, we discuss key discoveries related to BTK and clinically relevant aspects of BTK inhibitors, and we provide an outlook into clinical development and open questions regarding BTK inhibitor therapy. PMID:24778403

GW-501516 GlaxoSmithKline/Ligand.

PubMed

Pelton, Patricia

2006-04-01

GlaxoSmithKline and Ligand are developing GW-501516, a peroxisome proliferator-activator receptor-delta agonist for the potential treatment of dyslipidemia. Phase II clinical trials of this compound are ongoing.

Tenure Track Investigator | Center for Cancer Research

Cancer.gov

The Neuro-Oncology Branch (NOB), Center for Cancer Research (CCR) of the National Cancer Institute (NCI), National Institutes of Health (NIH), Department of Health and Human Services (HHS), Bethesda, MD, is actively recruiting for a tenure-track principal investigator to work in the area of immunology and/or immunotherapy.  The NOB Immunology/Immunotherapy Investigator will be tasked with forming and leading an independent research program.  This position will build the basic immunology program in the NOB and complement ongoing and planned translational research and clinical trials evaluating the effects of immunotherapy in patients with primary brain tumors.  This program will be able to access biospecimens generated from ongoing and planned immunotherapy protocols within the NOB, thus creating an opportunity to perform correlative studies to interrogate the complex biology of immunologic response, toxicity, and treatment resistance.  Demonstrated expertise in scientific inquiries in immunotherapy and/or immunology are essential, but prior work in brain tumors is not required.  This is an exciting opportunity to join a growing trans-institutional research team that promotes and supports collaborations across the basic, translational, and clinical research spectrum to develop novel therapeutics for individuals with primary central nervous system malignancies that will globally influence the field.

Osteosarcoma Genetics and Epigenetics: Emerging Biology and Candidate Therapies

PubMed Central

Morrow, James J.; Khanna, Chand

2016-01-01

Osteosarcoma is the most common primary malignancy of bone, typically presenting in the first or second decade of life. Unfortunately, clinical outcomes for osteosarcoma patients have not substantially improved in over 30 years. This stagnation in therapeutic advances is perhaps explained by the genetic, epigenetic, and biological complexities of this rare tumor. In this review we provide a general background on the biology of osteosarcoma and the clinical status quo. We go on to enumerate the genetic and epigenetic defects identified in osteosarcoma. Finally, we discuss ongoing large-scale studies in the field and potential new therapies that are currently under investigation. PMID:26349415

Primary Care Collaborative Memory Clinics: Building Capacity for Optimized Dementia Care.

PubMed

Lee, Linda; Hillier, Loretta M; Molnar, Frank; Borrie, Michael J

2017-01-01

Increasingly, primary care collaborative memory clinics (PCCMCs) are being established to build capacity for person-centred dementia care. This paper reflects on the significance of PCCMCs within the system of care for older adults, supported with data from ongoing evaluation studies. Results highlight timelier access to assessment with a high proportion of patients being managed in primary care within a person-centred approach to care. Enhancing primary care capacity for dementia care with interprofessional and collaborative care will strengthen the system's ability to respond to increasing demands for service and mitigate the growth of wait times to access geriatric specialist assessment.

Prostate cancer diagnostics: Clinical challenges and the ongoing need for disruptive and effective diagnostic tools.

PubMed

Sharma, Shikha; Zapatero-Rodríguez, Julia; O'Kennedy, Richard

The increased incidence and the significant health burden associated with carcinoma of the prostate have led to substantial changes in its diagnosis over the past century. Despite technological advancements, the management of prostate cancer has become progressively more complex and controversial for both early and late-stage disease. The limitations and potential harms associated with the use of prostate-specific antigen (PSA) as a diagnostic marker have stimulated significant investigation of numerous novel biomarkers that demonstrate varying capacities to detect prostate cancer and can decrease unnecessary biopsies. However, only a few of these markers have been approved for specific clinical settings while the others have not been adequately validated for use. This review systematically and critically assesses ongoing issues and emerging challenges in the current state of prostate cancer diagnostic tools and the need for disruptive next generation tools based on analysis of combinations of these biomarkers to enhance predictive accuracy which will benefit clinical diagnostics and patient welfare. Copyright © 2016. Published by Elsevier Inc.

Fresh embryo transfer versus frozen embryo transfer in in vitro fertilization cycles: a systematic review and meta-analysis.

PubMed

Roque, Matheus; Lattes, Karinna; Serra, Sandra; Solà, Ivan; Geber, Selmo; Carreras, Ramón; Checa, Miguel Angel

2013-01-01

To examine the available evidence to assess if cryopreservation of all embryos and subsequent frozen embryo transfer (FET) results in better outcomes compared with fresh transfer. Systematic review and meta-analysis. Centers for reproductive care. Infertility patient(s). An exhaustive electronic literature search in MEDLINE, EMBASE, and the Cochrane Library was performed through December 2011. We included randomized clinical trials comparing outcomes of IVF cycles between fresh and frozen embryo transfers. The outcomes of interest were ongoing pregnancy rate, clinical pregnancy rate, and miscarriage. We included three trials accounting for 633 cycles in women aged 27-33 years. Data analysis showed that FET resulted in significantly higher ongoing pregnancy rates and clinical pregnancy rates. Our results suggest that there is evidence that IVF outcomes may be improved by performing FET compared with fresh embryo transfer. This could be explained by a better embryo-endometrium synchrony achieved with endometrium preparation cycles. Copyright © 2013 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

The preconception diet is associated with the chance of ongoing pregnancy in women undergoing IVF/ICSI treatment.

PubMed

Twigt, J M; Bolhuis, M E C; Steegers, E A P; Hammiche, F; van Inzen, W G; Laven, J S E; Steegers-Theunissen, R P M

2012-08-01

Subfertility and poor nutrition are increasing problems in Western countries. Moreover, nutrition affects fertility in both women and men. In this study, we investigate the association between adherence to general dietary recommendations in couples undergoing IVF/ICSI treatment and the chance of ongoing pregnancy. Between October 2007 and October 2010, couples planning pregnancy visiting the outpatient clinic of the Department of Obstetrics and Gynaecology of the Erasmus Medical Centre in Rotterdam, the Netherlands were offered preconception counselling. Self-administered questionnaires on general characteristics and diet were completed and checked during the visit. Six questions, based on dietary recommendations of the Netherlands Nutrition Centre, covered the intake of six main food groups (fruits, vegetables, meat, fish, whole wheat products and fats). Using the questionnaire results, we calculated the Preconception Dietary Risk score (PDR), providing an estimate of nutritional habits. Dietary quality increases with an increasing PDR score. We define ongoing pregnancy as an intrauterine pregnancy with positive heart action confirmed by ultrasound. For this analysis we selected all couples (n=199) who underwent a first IVF/ICSI treatment within 6 months after preconception counselling. We applied adjusted logistic regression analysis on the outcomes of interest using SPSS. After adjustment for age of the woman, smoking of the woman, PDR of the partner, BMI of the couple and treatment indication we show an association between the PDR of the woman and the chance of ongoing pregnancy after IVF/ICSI treatment (odds ratio 1.65, confidence interval: 1.08-2.52; P=0.02]. Thus, a one-point increase in the PDR score associates with a 65% increased chance of ongoing pregnancy. Our results show that increasing adherence to Dutch dietary recommendations in women undergoing IVF/ICSI treatment increases the chance of ongoing pregnancy. These data warrant further confirmation in couples achieving a spontaneous pregnancy and in randomized controlled trials.

Role of Macrophage-Induced Inflammation in Mesothelioma

DTIC Science & Technology

2011-07-01

particularly the Plexxikon compound PLX -3397, a blocker of the CSF1 receptor. This compound has already entered clinical trials in some tumors...begun incubating hybrid spheroids and macrophages alone with the PLX - 3397 compound. After 24-48 h of PLX -3397, we have confirmed that macrophages...months 12-24). These studies are ongoing and will be completed in a few months, using the PLX -3397 compound instead of the more toxic clodronate

The first genome sequences of human bocaviruses from Vietnam

PubMed Central

Thanh, Tran Tan; Van, Hoang Minh Tu; Hong, Nguyen Thi Thu; Nhu, Le Nguyen Truc; Anh, Nguyen To; Tuan, Ha Manh; Hien, Ho Van; Tuong, Nguyen Manh; Kien, Trinh Trung; Khanh, Truong Huu; Nhan, Le Nguyen Thanh; Hung, Nguyen Thanh; Chau, Nguyen Van Vinh; Thwaites, Guy; van Doorn, H. Rogier; Tan, Le Van

2017-01-01

As part of an ongoing effort to generate complete genome sequences of hand, foot and mouth disease-causing enteroviruses directly from clinical specimens, two complete coding sequences and two partial genomic sequences of human bocavirus 1 (n=3) and 2 (n=1) were co-amplified and sequenced, representing the first genome sequences of human bocaviruses from Vietnam. The sequences may aid future study aiming at understanding the evolution of the virus. PMID:28090592

Teicoplanin inhibits Ebola pseudovirus infection in cell culture.

PubMed

Wang, Yizhuo; Cui, Rui; Li, Guiming; Gao, Qianqian; Yuan, Shilin; Altmeyer, Ralf; Zou, Gang

2016-01-01

There is currently no approved antiviral therapy for treatment of Ebola virus disease. To discover readily available approved drugs that can be rapidly repurposed for treatment of Ebola virus infections, we screened 1280 FDA-approved drugs and identified glycopeptide antibiotic teicoplanin inhibiting Ebola pseudovirus infection by blocking virus entry in the low micromolar range. Teicoplanin could be evaluated further and incorporated into ongoing clinical studies. Copyright © 2015 Elsevier B.V. All rights reserved.

Predictors of cerebral microembolization during phased radiofrequency ablation of atrial fibrillation: role of the ongoing rhythm and the site of energy delivery.

PubMed

Nagy-Balo, Edina; Kiss, Alexandra; Condie, Catherine; Stewart, Mark; Edes, Istvan; Csanadi, Zoltan

2014-11-01

Pulmonary vein isolation with phased radiofrequency current and use of a pulmonary vein ablation catheter (PVAC) has recently been associated with a high incidence of clinically silent brain infarcts on diffusion-weighted magnetic resonance imaging, and a high microembolic signal (MES) count detected by transcranial Doppler. We investigated the potential effects of the ongoing rhythm and the target vein during energy delivery (ED) on MES generation during PVAC ablations. A total of 735 EDs during 48 PVAC ablations were analyzed. MES counts were recorded for each ED and time-stamped for correlation with the ongoing rhythm and the target vein for each ED. Significantly higher MES counts were observed during ablations of the left-sided as compared with the right-sided pulmonary veins (P = 0.0003). Similarly, higher MES counts were detected during EDs in atrial fibrillation as compared with sinus rhythm when the temperature was >56°C (P < 0.0001). The ongoing rhythm had no effect on the number of MESs at lower temperatures during ablation. Both the ongoing rhythm during ED and the site of ablation influence microembolus generation during PVAC ablation procedures. ©2014 Wiley Periodicals, Inc.

Ocular morbidities of juvenile idiopathic arthritis-associated uveitis in adulthood: results from a tertiary center study.

PubMed

Oray, Merih; Khachatryan, Naira; Ebrahimiadib, Nazanin; Abu Samra, Khawla; Lee, Stacey; Foster, C Stephen

2016-09-01

To describe the clinical and visual outcomes of juvenile idiopathic arthritis (JIA)-associated uveitis in adults and to examine risk factors for ongoing inflammation in adulthood. Medical records were reviewed for patients with JIA-associated uveitis who were >16 years old at the final visit (the last visit prior to data collection). In total, 135 eyes of 77 patients (70 female, 7 male) were included. The mean age of patients at the final visit was 29.72 ± 11.27 years. The number of eyes with visual acuity of ≤20/50 and ≤20/200 at the final visit was 37 (28 %) and 20 (15 %), respectively; at least one ocular complication was present in 72 % of eyes. Band keratopathy was the most frequent complication (42 %), followed by cataract (25 %), posterior synechiae (22 %), maculopathy (22 %), ocular hypertension (13 %), and hypotony (5 %). At the final visit, patients who were >16 years of age at presentation to the Massachusetts Eye Research and Surgery Institution had more ocular complications and a greater degree of vision loss than patients who were ≤16 years of age. Ongoing inflammation at the final visit was noted in 40 patients (52 %). The presence of posterior synechiae, hypotony, cataract at presentation, and a history of cataract surgery prior to presentation were predictive of ongoing inflammation in adulthood in univariate analysis. The presence of hypotony and posterior synechiae at the initial visit were predictive factors in multivariate analysis. JIA-associated uveitis may be associated with ongoing inflammation, ocular complications, and severe visual impairment in adulthood. The presence of posterior synechiae and hypotony at the initial visit is predictive of ongoing inflammation.

Examining Child Welfare Decisions and Services for Asian-Canadian Versus White-Canadian Children and Families in the Child Welfare System.

PubMed

Lee, Barbara; Fuller-Thomson, Esme; Fallon, Barbara; Black, Tara; Trocmé, Nico

2017-05-01

Using administrative child welfare data from the Ontario Child Abuse and Neglect Data System (OCANDS), this study compared the profiles of Asian-Canadian and White-Canadian children and families that experienced a case closure after an investigation instead of being transferred to ongoing child protection services (CPS). Child protection investigations involving Asian-Canadian and White-Canadian children and families that were transferred to ongoing CPS presented a different profile of case characteristics and caregiver and child clinical needs. Asian-Canadian children and families received ongoing CPS for over a month longer than White-Canadian children and families and were less likely (odds ratio [ OR] = 0.39) to be reinvestigated for any form of maltreatment-related concerns within 1 year after case closure. It appears that child protection investigations involving Asian-Canadian children and families are less likely to be closed prematurely than White-Canadian children and families, and the child protection system may be meeting the needs of Asian-Canadian communities. Alternatively, it is possible there is unaccounted biases that may be reflective of systemic problem of discriminative practices in the child protection system. Further research is needed to explore this phenomenon.

Comparison of injectable molindone and haloperidol followed by oral dosage forms in acutely ill schizophrenics.

PubMed

Escobar, J I; Mann, J J; Keller, J; Wilkins, J; Mason, B; Mills, M J

1985-08-01

The comparative efficacy of molindone and haloperidol, given by injection for the first 2-3 days of hospitalization and then continued orally for up to 4 weeks, is reported from an ongoing double-blind study. Efficacy and side effects were assessed by the Brief Psychiatric Rating Scale, Clinical Global Impressions, Treatment Emergent Symptom Scale, and Target Symptom Ratings. Analyses based on the first 35 patients who entered the study indicate that both drugs were effective and well tolerated. There were slight advantages for molindone early during the injectable phase of treatment and for haloperidol late during the oral portion of the study, but these differences were not clinically significant. No significant differences in side effects were found between the two drugs.

Stroke: Hope through Research

MedlinePlus

... the Barthel Index. Imaging for the Diagnosis of Acute Stroke Health care professionals also use a variety ... risk population. top Ongoing Clinical Trials Albumin in Acute Ischemic Stroke (ALIAS) Trial Human serum albumin is ...

Recombinant Human Papillomavirus (HPV) Quadrivalent Vaccine

Cancer.gov

This page contains brief information about recombinant human papillomavirus (HPV) quadrivalent vaccine and a collection of links to more information about the use of this vaccine, research results, and ongoing clinical trials.

Recombinant Human Papillomavirus (HPV) Nonavalent Vaccine

Cancer.gov

This page contains brief information about recombinant human papillomavirus (HPV) nonavalent vaccine and a collection of links to more information about the use of this vaccine, research results, and ongoing clinical trials.

Recombinant Human Papillomavirus (HPV) Bivalent Vaccine

Cancer.gov

This page contains brief information about recombinant human papillomavirus (HPV) bivalent vaccine and a collection of links to more information about the use of this vaccine, research results, and ongoing clinical trials.

[Modern technologies and prospects of rehabilitation of patients after ischemic stroke].

PubMed

Ekusheva, E V

Despite the great achievements in the field of neurorehabilitation, a significant proportion of patients after an ischemic stroke have persistent motor disturbances even after timely and adequately carried out restorative measures. The article discusses the issues of neuroplasticity, modern diagnostic technologies for studying this phenomenon; prognostic factors for recovery deficit following stroke and determining the effectiveness of ongoing treatment. The principles of neuroprotective therapy in ischemic stroke are considered, which is a pathogenetically justified direction at all stages of restorative treatment after cerebral circulation disorders. One of the most studied original cytoprotectors, demonstrating safety, efficacy and good tolerability, is cytoflavin. The results of numerous clinical trials have revealed a significant positive clinical and morphological dynamics when taking cytoflavin in patients after ischemic stroke.

Robotics in invasive cardiac electrophysiology.

PubMed

Shurrab, Mohammed; Schilling, Richard; Gang, Eli; Khan, Ejaz M; Crystal, Eugene

2014-07-01

Robotic systems allow for mapping and ablation of different arrhythmia substrates replacing hand maneuvering of intracardiac catheters with machine steering. Currently there are four commercially available robotic systems. Niobe magnetic navigation system (Stereotaxis Inc., St Louis, MO) and Sensei robotic navigation system (Hansen Medical Inc., Mountain View, CA) have an established platform with at least 10 years of clinical studies looking at their efficacy and safety. AMIGO Remote Catheter System (Catheter Robotics, Inc., Mount Olive, NJ) and Catheter Guidance Control and Imaging (Magnetecs, Inglewood, CA) are in the earlier phases of implementations with ongoing feasibility and some limited clinical studies. This review discusses the advantages and limitations related to each existing system and highlights the ideal futuristic robotic system that may include the most promising features of the current ones.

Comparative gait analysis of ankle arthrodesis and arthroplasty: initial findings of a prospective study.

PubMed

Hahn, Michael E; Wright, Elise S; Segal, Ava D; Orendurff, Michael S; Ledoux, William R; Sangeorzan, Bruce J

2012-04-01

Little is known about functional outcomes of ankle arthroplasty compared with arthrodesis. This study compared pre-surgical and post-surgical gait measures in both patient groups. Eighteen patients with end-stage ankle arthritis participated in an ongoing longitudinal study (pre-surgery, 12 months post-surgery) involving gait analysis, assessment of pain and physical function. Outcome measures included temporal-distance, kinematic and kinetic data, the Short Form 36 (SF-36) body pain score, and average daily step count. A mixed effects linear model was used to detect effects of surgical group (arthrodesis and arthroplasty, n = 9 each) with walking speed as a covariate (α = 0.05). Both groups were similar in demographics and anthropometrics. Followup time was the same for each group. There were no complications in either group. Pain decreased (p < 0.001) and gait function improved (gait velocity, p = 0.02; stride length, p = 0.035) in both groups. Neither group increased average daily step count. Joint range of motion (ROM) differences were observed between groups after surgery (increased hip ROM in arthrodesis, p = 0.001; increased ankle ROM in arthroplasty, p = 0.036). Peak plantar flexor moment increased in arthrodesis patients and decreased in arthroplasty patients (p = 0.042). Initial findings of this ongoing clinical study indicate pain reduction and improved gait function 12 months after surgery for both treatments. Arthroplasty appears to regain more natural ankle joint function, with increased ROM. Long-term follow up should may reveal more clinically meaningful differences.

Reconstructive Surgery of Auricular Defects: An Overview.

PubMed

Ebrahimi, Ali; Kazemi, Alireza; Rasouli, Hamid Reza; Kazemi, Maryam; Kalantar Motamedi, Mohammad Hosein

2015-11-01

Despite the ongoing advances in surgical procedures and promising progress in bioengineering techniques, auricular reconstruction remains a significant challenge in plastic surgery. There are different causes for acquired auricular defects, including trauma, tumor ablation and burns. The management options for upper, middle and lower third auricular defects are briefly reviewed in the current paper. Original research papers investigating the plastic surgeons, otolaryngologists and maxillofacial surgeons in approaching the complicated issue of auricular reconstruction published from January 1995 to December 2014 were aggregated and used in the current study. Utilizing autologous stem cell populations to treat craniofacial defects is a promising field of ongoing investigations. Studies show that cartilage stem/progenitor cells (CSPCs) are highly chondrogenic and can produce elastic reconstructive material with long-term tissue restoration. Auricular reconstruction surgery is a challenging plastic procedure that requires great expertise and expert knowledge of the various techniques available. Novel techniques in the fields of reconstructive bioengineering and regenerative medicine are promising but further research is required before widespread clinical application.

A Clinical Librarian-Nursing Partnership to Bridge Clinical Practice and Research in an Oncology Setting.

PubMed

Ginex, Pamela K; Hernandez, Marisol; Vrabel, Mark

2016-09-01

Nurses in clinical settings in which evidence-based, individualized care is expected are often the best resource to identify important clinical questions and gaps in practice. These nurses are frequently challenged by a lack of resources to fully develop their questions and identify the most appropriate methods to answer them. A strategic and ongoing partnership between medical library services and nursing can support nurses as they embark on the process of answering these questions and, ultimately, improving patient care and clinical outcomes

Metro-Minnesota Community Clinical Oncology Program (MM-CCOP) | Division of Cancer Prevention

Cancer.gov

The Metro-Minnesota Community Clinical Oncology (MMCCOP) program has a long-standing history which clearly demonstrates the success of the consortium, as demonstrated by both the ongoing commitment of the original consortium members and the growth of the consortium from 1979 through 2014. The MMCCOP consortium represents an established community program base which began in

Clinical decision-making described by Swedish prehospital emergency care nurse students - An exploratory study.

PubMed

Nilsson, Tomas; Lindström, Veronica

2016-07-01

The purpose of this study was to explore the PECN students' clinical decision-making during a seven-week clinical rotation in the ambulance services. Developing expertise in prehospital emergency care practices requires both theoretical and empirical learning. A prehospital emergency care nurse (PECN) is a Registered Nurse (RN) with one year of additional training in emergency care. There has been little investigation of how PECN students describe their decision-making during a clinical rotation. A qualitative study design was used, and 12 logbooks written by the Swedish PECN students were analysed using content analysis. The students wrote about 997 patient encounters - ambulance assignments during their clinical rotation. Four themes emerged as crucial for the students' decision-making: knowing the patient, the context-situation awareness in the ambulance service, collaboration, and evaluation. Based on the themes, students made decisions on how to respond to patients' illnesses. The PECN students used several variables in their decision-making. The decision- making was an on-going process during the whole ambulance assignment. The university has the responsibility to guide the students during their transition from an RN to a PECN. The findings of the study can support the educators and clinical supervisors in developing the programme of study for becoming a PECN. Copyright © 2015 Elsevier Ltd. All rights reserved.

Endometrial thickness affects the outcome of in vitro fertilization and embryo transfer in normal responders after GnRH antagonist administration.

PubMed

Wu, Yu; Gao, Xiaohong; Lu, Xiang; Xi, Ji; Jiang, Shan; Sun, Yin; Xi, Xiaowei

2014-10-09

The goal of this study was to assess the association between endometrial thickness on the chorionic gonadotropin (hCG) day and in vitro fertilization and embryo transfer (IVF-ET) outcome in normal responders after GnRH antagonist administration. A retrospective cohort study was performed in normal responders with GnRH antagonist administration from January 2011-December 2013. Patients were divided into four groups according to endometrial thickness, as follows: <7 mm (group 1), > = 7- < 8 mm (group 2), > = 8- < 14 mm (group 3), and > =14 mm (group 4). A total of 2106 embryo transfer cycles were analyzed. The pregnancy rate (PR) was 44.87%.The clinical pregnancy rate, ongoing pregnancy rate and the implantation rate (17.28%, 13.79%, 10.17%, respectively) were significantly lower in group 1 compared to the other three groups (p < 0.05). The miscarriage rate was higher in patients with endometrial thickness less than 7 mm. The clinical pregnancy rate, ongoing pregnancy rate and implantation rate were highest in patients with endometrial thickness higher than 14 mm, but showed no difference in patients with those of endometrial thickness between 8-14 mm. There is a correlation between endometrial thickness measured on hCG day and clinical outcome in normal responders with GnRH antagonist administration. The pregnancy rate was lower in patients with endometrial thickness less than 7 mm compared with patients with endometrial thickness more than 7 mm.

Bioresorbable scaffolds: talking about a new interventional revolution [corrected].

PubMed

Hassell, M E C J; Grundeken, M J D; Delewi, R; Wykrzykowska, J J; Piek, J J

2013-04-01

After the introduction of coronary balloon angioplasty, bare-metal, and drug-eluting stents, fully bioresorbable scaffolds (BRS) could be the fourth revolution in interventional cardiology. The BRS technology shares the advantages of metallic stents regarding acute gain and prevention of acute vessel occlusion by providing transient scaffolding, while potentially overcoming many of the safety concerns of drug-eluting stents. Furthermore, without a permanent metallic cage, the vessel could remodel favourably and atherosclerotic plaques could regress in the long-term. This attracted increased interest and several BRS have been developed. In this review we will describe all BRS which are thus far clinically evaluated and provide an overview of ongoing clinical studies. Although the technology seems to be very promising, more studies including patients with more complex lesions are needed to evaluate whether the BRS can be used in daily clinical practice and if it is indeed becoming a new interventional revolution.

Combination Immunotherapy in Non-small Cell Lung Cancer.

PubMed

Marmarelis, Melina E; Aggarwal, Charu

2018-05-08

Checkpoint blockade has changed the treatment landscape in non-small cell lung cancer (NSCLC), but single-agent approaches are effective for only a select subset of patients. Here, we will review the evidence for combination immunotherapies in NSCLC and the clinical data evaluating the efficacy of this approach. Clinical trials evaluating combination PD-1 and CTLA-4 blockade as well as PD-1 in combination with agents targeting IDO1, B7-H3, VEGF, and EGFR show promising results. Additional studies targeting other immune pathways like TIGIT, LAG-3, and cellular therapies are ongoing. Combination immunotherapy has the potential to improve outcomes in NSCLC. Data from early clinical trials is promising and reveals that these agents can be administered together safely without a significant increase in toxicity. Further studies are needed to evaluate their long-term safety and efficacy and to determine appropriate patient selection.

Early investigational tubulin inhibitors as novel cancer therapeutics.

PubMed

Nepali, Kunal; Ojha, Ritu; Lee, Hsueh-Yun; Liou, Jing-Ping

2016-08-01

Microtubules represent one of the most logical and strategic molecular targets amongst the current targets for chemotherapy, alongside DNA. In the past decade, tubulin inhibitors as cancer therapeutics have been an area of focus due to the improved understanding and biological relevance of microtubules in cellular functions. Fueled by the objective of developing novel chemotherapeutics and with the aim of establishing the benefits of tubulin inhibition, several clinical trials have been conducted with others ongoing. At present, the antitubulin development pipeline contains an armful of agents under clinical investigation. This review focuses on novel tubulin inhibitors as cancer therapeutics. The article covers the agents which have completed the phase II studies along with the agents demonstrating promising results in phase I studies. Countless clinical trials evaluating the efficacy, safety and pharmacokinetics of novel tubulin inhibitors highlights the scientific efforts being paid to establish their candidature as cancer therapeutics. Colchicine binding site inhibitors as vascular disrupting agents (VDAs) and new taxanes appear to be the most likely agents for future clinical interest. Numerous agents have demonstrated clinical benefits in terms of efficacy and survival in phase I and II studies. However conclusive benefits can only be ascertained on the basis of phase III studies.

High Reliability Organization and Applicability to the Battlefield to Reduce Errors Associated with Combat Casualty Care

DTIC Science & Technology

2016-06-10

I placed on the search engine: “English language,” “5 years.” Journal categories included core clinical journals , dental journals , MEDLINE, and...Army) AE Adverse event AHRQ Agency for Healthcare Research and Quality AHS Army Health System AMEDD Army Medical Department CPQ Clinical Practice...harm to a patient (Joint Commission 2015). Clinical Quality Management: A systematic, organized , multidisciplinary approach to the ongoing

Pregnancy as a Window to Future Cardiovascular Health: Design and Implementation of the nuMoM2b Heart Health Study.

PubMed

Haas, David M; Ehrenthal, Deborah B; Koch, Matthew A; Catov, Janet M; Barnes, Shannon E; Facco, Francesca; Parker, Corette B; Mercer, Brian M; Bairey-Merz, C Noel; Silver, Robert M; Wapner, Ronald J; Simhan, Hyagriv N; Hoffman, Matthew K; Grobman, William A; Greenland, Philip; Wing, Deborah A; Saade, George R; Parry, Samuel; Zee, Phyllis C; Reddy, Uma M; Pemberton, Victoria L; Burwen, Dale R

2016-03-15

The National Institute of Child Health and Human Development's Nulliparous Pregnancy Outcomes Study-Monitoring Mothers-to-Be (nuMoM2b) Heart Health Study (HHS) was designed to investigate the relationships between adverse pregnancy outcomes and modifiable risk factors for cardiovascular disease. The ongoing nuMoM2b-HHS, which started in 2013, is a prospective follow-up of the nuMoM2b cohort, which included 10,038 women recruited between 2010 and 2013 from 8 centers across the United States who were initially observed over the course of their first pregnancies. In this report, we detail the design and study procedures of the nuMoM2b-HHS. Women in the pregnancy cohort who consented to be contacted for participation in future studies were approached at 6-month intervals to ascertain health information and to maintain ongoing contact. Two to 5 years after completion of the pregnancy documented in the nuMoM2b, women in the nuMoM2b-HHS were invited to an in-person study visit. During this visit, they completed psychosocial and medical history questionnaires and had clinical measurements and biological specimens obtained. A subcohort of participants who had objective assessments of sleep-disordered breathing during pregnancy were asked to repeat this investigation. This unique prospective observational study includes a large, geographically and ethnically diverse cohort, rich depth of phenotypic information about adverse pregnancy outcomes, and clinical data and biospecimens from early in the index pregnancy onward. Data obtained from this cohort will provide mechanistic and clinical insights into how data on a first pregnancy can provide information about the potential development of subsequent risk factors for cardiovascular disease. © The Author 2016. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Ongoing training of community health workers in low-income and middle-income countries: a systematic scoping review of the literature

PubMed Central

O’Donovan, Charles; Kuhn, Isla; Sachs, Sonia Ehrlich

2018-01-01

Objectives Understanding the current landscape of ongoing training for community health workers (CHWs) in low-income and middle-income countries (LMICs) is important both for organisations responsible for their training, as well as researchers and policy makers. This scoping review explores this under-researched area by mapping the current delivery implementation and evaluation of ongoing training provision for CHWs in LMICs. Design Systematic scoping review. Data sources MEDLINE, Embase, AMED, Global Health, Web of Science, Scopus, ASSIA, LILACS, BEI and ERIC. Study selection Original studies focusing on the provision of ongoing training for CHWs working in a country defined as low income and middle income according to World Bank Group 2012 classification of economies. Results The scoping review found 35 original studies that met the inclusion criteria. Ongoing training activities for CHWs were described as supervision (n=19), inservice or refresher training (n=13) or a mixture of both (n=3). Although the majority of studies emphasised the importance of providing ongoing training, several studies reported no impact of ongoing training on performance indicators. The majority of ongoing training was delivered inperson; however, four studies reported the use of mobile technologies to support training delivery. The outcomes from ongoing training activities were measured and reported in different ways, including changes in behaviour, attitudes and practice measured in a quantitative manner (n=16), knowledge and skills (n=6), qualitative assessments (n=5) or a mixed methods approach combining one of the aforementioned modalities (n=8). Conclusions This scoping review highlights the diverse range of ongoing training for CHWs in LMICs. Given the expansion of CHW programmes globally, more attention should be given to the design, delivery, monitoring and sustainability of ongoing training from a health systems strengthening perspective. PMID:29705769

Ethical considerations for clinical photography in the global South.

PubMed

Macintosh, Tracy

2006-05-01

Clinical photography is an important tool for teaching practitioners and field workers about the clinical manifestations of famine and undernutrition, particularly with respect to the Global South. Current international guidelines for clinical photography are not consistently applied or enforced, which has led to violations of privacy and rights, particularly for patients and victims of disaster in the Global South. Combining existing clinical photography guidelines from the North with ongoing clinical ethics debates in the South, this paper explores approaches to establishing photography guidelines throughout the world that will be sensitive to the privacy and dignities of all patients and victims of emergencies.

Long-term follow-up of HIV seroconverters in microbicide trials - rationale, study design, and challenges in MTN-015.

PubMed

Riddler, Sharon A; Husnik, Marla; Gorbach, Pamina M; Levy, Lisa; Parikh, Urvi; Livant, Edward; Pather, Arendevi; Makanani, Bonus; Muhlanga, Felix; Kasaro, Margaret; Martinson, Francis; Elharrar, Vanessa; Balkus, Jennifer E

2016-09-01

As the effect of biomedical prevention interventions on the natural history of HIV-1 infection in participants who seroconvert is unknown, the Microbicide Trials Network (MTN) established a longitudinal study (MTN-015) to monitor virologic, immunological, and clinical outcomes, as well as behavioral changes among women who become HIV-infected during MTN trials. We describe the rationale, study design, implementation, and enrollment of the initial group of participants in the MTN seroconverter cohort. Initiated in 2008, MTN-015 is an ongoing observational cohort study enrolling participants who acquire HIV-1 infection during effectiveness studies of candidate microbicides. Eligible participants from recently completed and ongoing MTN trials are enrolled after seroconversion and return for regular follow-up visits with clinical and behavioral data collection. Biologic samples including blood and genital fluids are stored for future testing. MTN-015 was implemented initially at six African sites and enrolled 100/139 (72%) of eligible women who seroconverted in HIV Prevention Trials Network protocol 035 (HPTN 035, conducted by the MTN). The median time from seroconversion in HPTN 035 to enrollment in MTN-015 was 18 months. Retention was good with >70% of visits completed. Implementation challenges included regulatory reviews, translation, and testing of questionnaires, and site readiness. Enrollment of HIV-seroconverters into a longitudinal observational follow-up study is feasible and acceptable to participants. Data and samples collected in this protocol will be used to assess safety of investigational HIV microbicides and answer other important public health questions for HIV infected women.

Ongoing measles outbreak in Wallonia, Belgium, December 2016 to March 2017: characteristics and challenges.

PubMed

Grammens, Tine; Schirvel, Carole; Leenen, Sylvie; Shodu, Nathalie; Hutse, Veronik; Mendes da Costa, Elise; Sabbe, Martine

2017-04-27

We describe characteristics of an ongoing measles outbreak in Wallonia, Belgium, and difficulties in control measures implementation. As at 12 March 2017, 177 measles cases were notified, of which 50% were 15 years and older, 49% female. Atypical clinical presentation and severe complications, mainly among adults, in combination with late notification, low or unknown vaccination coverage of contacts, infected healthcare workers and increased workload due to contact tracing, are the main concerns for outbreak management. This article is copyright of The Authors, 2017.

Self-administered multi-level pregnancy tests in simplified follow-up of medical abortion in Tunisia.

PubMed

Dabash, Rasha; Shochet, Tara; Hajri, Selma; Chelli, Héla; Hassairi, Anne-Emmanuele; Haleb, Douha; Labassi, Hayet; Sfar, Ezzedine; Temimi, Fatma; Koenig, Leah; Winikoff, Beverly

2016-07-30

This study was conducted to assess the efficacy and acceptability of using a multi-level pregnancy test (MLPT) combined with telephone follow-up for medical abortion in Tunisia, where the majority of providers are midwives. Four hundred and four women with gestational age ≤ 70 days' LMP seeking medical abortion at six study sites were enrolled in this open-label trial. Participants administered a baseline MLPT at the clinic prior to mifepristone administration and were asked to take a second MLPT at home and to call in its results before returning the day of their scheduled follow-up visit 10-14 days later. Almost all women with follow-up (97.1 %, n = 332/342) had successful abortions without the need for surgical intervention. The MLPT worked extremely well among women ≤63 days' LMP in ruling out ongoing pregnancy (negative predictive value (NPV) =100 % (n = 298/298)) and also detecting women with ongoing pregnancies (sensitivity = 100 %; 2/2) as needing follow-up due to non-declining hCG. Among women 64-70 days' LMP, the test also worked well in ruling out ongoing pregnancy (NPV = 96.9 % (n = 31/32) but not as well in terms of sensitivity (50 %), with only one of two ongoing pregnancies detected by MLPT as needing follow-up. Most women (95.1 %) found the MLPT to be very easy or easy to use and would consider using the MLPT again (97.4 %) if needed. Self-administered pre and post MLPT are very easy for women to use and accurate in assessing medical abortion success up to 63 days' LMP. MLPT use for medical abortion follow-up has the potential to facilitate task sharing services and eliminate the burden of routine in-person follow-up visits for the large majority of women. Additional research is warranted to explore the accuracy of the MLPT in identifying ongoing pregnancy among women with gestational ages > 63 days. This study was registered on May 13, 2010, on clinicaltrials.gov as NCT01150279 .

Public reporting helped drive quality improvement in outpatient diabetes care among Wisconsin physician groups

PubMed Central

Smith, Maureen A.; Wright, Alexandra; Queram, Christopher; Lamb, Geoffrey C.

2012-01-01

Public reporting on the quality of ambulatory health care is growing, but knowledge of how physician groups respond to such reporting has not kept pace. We examined responses to public reporting on the quality of diabetes care in 409 primary care clinics within seventeen large, multispecialty physician groups. We determined that a focus on publicly reported metrics, along with participation in large or externally sponsored projects, increased a clinic’s implementation of diabetes improvement interventions. Clinics were also more likely to implement interventions in more recent years. Public reporting helped drive both early implementation of a single intervention and ongoing implementation of multiple simultaneous interventions. To fully engage physician groups, accountability metrics should be structured to capture incremental improvements in quality, thereby rewarding both early and ongoing improvement activities. PMID:22392668

Micropuncture retrieval of epididymal sperm with in vitro fertilization: importance of in vitro micromanipulation techniques.

PubMed

Schlegel, P N; Palermo, G D; Alikani, M; Adler, A; Reing, A M; Cohen, J; Rosenwaks, Z

1995-08-01

To evaluate the importance of in vitro micromanipulation techniques, specifically intracytoplasmic sperm injection (ICSI), for the fertility treatment of men with congenital absence of the vas deferens (CAV) or other unreconstructable male reproductive tract obstruction. Results using ICSI during in vitro fertilization (IVF) were compared to previously published results of IVF alone and IVF with other micromanipulation techniques at the same infertility center. Main outcome parameters evaluated were: fertilization rate per oocyte, clinical pregnancy rate, and ongoing pregnancies and deliveries. IVF with ICSI yielded a fertilization rate per oocyte of 140 of 312 (45%) and a clinical pregnancy rate of 14 of 27 (52%) per cycle of sperm and egg retrieval. Ongoing pregnancies or deliveries have occurred for 13 of 27 (48%) cycles with ICSI. These results were better than our previously published results of IVF alone or in conjunction with the micromanipulation techniques of subzonal insertion (SuZI) or partial zona dissection (PZD) that yielded a 119 of 631 (19%; P < 0.0001) fertilization rate, clinical pregnancy rate of 14 of 51 (27%; P < 0.001) and ongoing pregnancy or delivery for 12 of 51 cycles (24%; P < 0.001). Epididymal sperm retrieval should be performed only when micromanipulation is available in conjunction with IVF to maximize chances of fertilization and subsequent pregnancies. The use of ICSI for epididymal sperm appears to maximize chances of pregnancy for couples with surgically unreconstructable obstructive male infertility.

Precision Oncology: A New Era of Cancer Clinical Trials

PubMed Central

Renfro, Lindsay A.; An, Ming-Wen; Mandrekar, Sumithra J.

2016-01-01

Traditionally, site of disease and anatomic staging have been used to define patient populations to be studied in individual cancer clinical trials. In the past decade, however, oncology has become increasingly understood on a cellular and molecular level, with many cancer subtypes being described as a function of biomarkers or tumor genetic mutations. With these changes in the science of oncology have come changes to the way we design and perform clinical trials. Increasingly common are trials tailored to detect enhanced efficacy in a patient subpopulation, e.g., patients with a known biomarker value or whose tumors harbor a specific genetic mutation. Here, we provide an overview of traditional and newer biomarker-based trial designs, and highlight lessons learned through implementation of several ongoing and recently completed trials. PMID:26987624

Targeting cancer with kinase inhibitors

PubMed Central

Gross, Stefan; Rahal, Rami; Stransky, Nicolas; Lengauer, Christoph; Hoeflich, Klaus P.

2015-01-01

Kinase inhibitors have played an increasingly prominent role in the treatment of cancer and other diseases. Currently, more than 25 oncology drugs that target kinases have been approved, and numerous additional therapeutics are in various stages of clinical evaluation. In this Review, we provide an in-depth analysis of activation mechanisms for kinases in cancer, highlight recent successes in drug discovery, and demonstrate the clinical impact of selective kinase inhibitors. We also describe the substantial progress that has been made in designing next-generation inhibitors to circumvent on-target resistance mechanisms, as well as ongoing strategies for combining kinase inhibitors in the clinic. Last, there are numerous prospects for the discovery of novel kinase targets, and we explore cancer immunotherapy as a new and promising research area for studying kinase biology. PMID:25932675

Delamanid (OPC-67683) for treatment of multi-drug-resistant tuberculosis.

PubMed

Sotgiu, Giovanni; Pontali, Emanuele; Centis, Rosella; D'Ambrosio, Lia; Migliori, Giovanni Battista

2015-03-01

The research and development of delamanid was carried out by Otsuka Pharmaceutical Development and Commercialization (Osaka, Tokyo, Japan). It belongs to the group of nitroimidazoles. It inhibits the synthesis of mycolic acids, crucial component of the cell wall of the Mycobacterium tuberculosis complex. It is insoluble in water and its activity was proven in several in vitro and in vivo studies. Its market approval was obtained in April 2014 in Europe. Its bactericidal activity was demonstrated in individuals with drug-susceptible and drug-resistant tuberculosis (MDR- and XDR-TB). The safety and tolerability profile was good; the notified increased QT interval was not clinically relevant. It was approved for adults but ongoing clinical trials and clinical experiences have been proving its efficacy in the pediatric population.

Patterns of separation anxiety symptoms amongst pregnant women in conflict-affected Timor-Leste: Associations with traumatic loss, family conflict, and intimate partner violence.

PubMed

Silove, D M; Tay, A K; Tol, W A; Tam, N; Dos Reis, N; da Costa, Z; Soares, C; Rees, S

2016-11-15

Adult separation anxiety (ASA) symptoms are prevalent amongst young women in low and middle-income countries and symptoms may be common in pregnancy. No studies have focused on defining distinctive patterns of ASA symptoms amongst pregnant women in these settings or possible associations with trauma exposure and ongoing stressors. In a consecutive sample of 1672 women attending antenatal clinics in Dili, Timor-Leste (96% response), we assessed traumatic events of conflict, ongoing adversity, intimate partner violence (IPV), ASA, post-traumatic stress disorder (PTSD) and severe psychological distress. Latent Class Analysis was used to identify classes of women based on their distinctive profiles of ASA symptoms, comparisons then being made with key covariates including trauma domains of conflict, intimate partner violence (IPV) and ongoing stressors. LCA yielded three classes, comprising a core ASA (4%), a limited ASA (25%) and a low symptom class (61%). The core ASA class reported exposure to multiple traumatic losses and IPV and showed a pattern of comorbidity with PTSD; the limited ASA class predominantly reported exposure to ongoing stressors and was comorbid with severe psychological distress; the low symptom class reported relatively low levels of exposure to trauma and stressors. The study is cross-sectional, cautioning against inferring causal inferences. The core ASA group may be in need of immediate intervention given the high rate of exposure to IPV amongst this class. A larger number of women experiencing a limited array of non-specific ASA symptoms may need assistance to address the immediate stressors of pregnancy. Copyright © 2016 Elsevier B.V. All rights reserved.

Preimplantation genetic diagnosis and screening by array comparative genomic hybridisation: experience of more than 100 cases in a single centre.

PubMed

Chow, J Fc; Yeung, W Sb; Lee, V Cy; Lau, E Yl; Ho, P C; Ng, E Hy

2017-04-01

Preimplantation genetic screening has been proposed to improve the in-vitro fertilisation outcome by screening for aneuploid embryos or blastocysts. This study aimed to report the outcome of 133 cycles of preimplantation genetic diagnosis and screening by array comparative genomic hybridisation. This study of case series was conducted in a tertiary assisted reproductive centre in Hong Kong. Patients who underwent preimplantation genetic diagnosis for chromosomal abnormalities or preimplantation genetic screening between 1 April 2012 and 30 June 2015 were included. They underwent in-vitro fertilisation and intracytoplasmic sperm injection. An embryo biopsy was performed on day-3 embryos and the blastomere was subject to array comparative genomic hybridisation. Embryos with normal copy numbers were replaced. The ongoing pregnancy rate, implantation rate, and miscarriage rate were studied. During the study period, 133 cycles of preimplantation genetic diagnosis for chromosomal abnormalities or preimplantation genetic screening were initiated in 94 patients. Overall, 112 cycles proceeded to embryo biopsy and 65 cycles had embryo transfer. The ongoing pregnancy rate per transfer cycle after preimplantation genetic screening was 50.0% and that after preimplantation genetic diagnosis was 34.9%. The implantation rates after preimplantation genetic screening and diagnosis were 45.7% and 41.1%, respectively and the miscarriage rates were 8.3% and 28.6%, respectively. There were 26 frozen-thawed embryo transfer cycles, in which vitrified and biopsied genetically transferrable embryos were replaced, resulting in an ongoing pregnancy rate of 36.4% in the screening group and 60.0% in the diagnosis group. The clinical outcomes of preimplantation genetic diagnosis and screening using comparative genomic hybridisation in our unit were comparable to those reported internationally. Genetically transferrable embryos replaced in a natural cycle may improve the ongoing pregnancy rate and implantation rate when compared with transfer in a stimulated cycle.

Reengineering a database for clinical trials management: lessons for system architects.

PubMed

Brandt, C A; Nadkarni, P; Marenco, L; Karras, B T; Lu, C; Schacter, L; Fisk, J M; Miller, P L

2000-10-01

This paper describes the process of enhancing Trial/DB, a database system for clinical studies management. The system's enhancements have been driven by the need to maximize the effectiveness of developer personnel in supporting numerous and diverse users, of study designers in setting up new studies, and of administrators in managing ongoing studies. Trial/DB was originally designed to work over a local area network within a single institution, and basic architectural changes were necessary to make it work over the Internet efficiently as well as securely. Further, as its use spread to diverse communities of users, changes were made to let the processes of study design and project management adapt to the working styles of the principal investigators and administrators for each study. The lessons learned in the process should prove instructive for system architects as well as managers of electronic patient record systems.

Relationship between arsenic skin lesions and the age of natural menopause.

PubMed

Yunus, Fakir Md; Rahman, Musarrat Jabeen; Alam, Md Zahidul; Hore, Samar Kumar; Rahman, Mahfuzar

2014-05-02

Chronic exposure to arsenic is associated with neoplastic, cardiovascular, endocrine, neuro-developmental disorders and can have an adverse effect on women's reproductive health outcomes. This study examined the relationship between arsenic skin lesions (a hallmark sign of chronic arsenic poisoning) and age of natural menopause (final menopausal period) in populations with high levels of arsenic exposure in Bangladesh. We compared menopausal age in two groups of women--with and without arsenic skin lesions; and presence of arsenic skin lesions was used as an indicator for chronic arsenic exposure. In a cross-sectional study, a total of 210 participants were randomly identified from two ongoing studies--participants with arsenic skin lesions were identified from an ongoing clinical trial and participants with no arsenic skin lesions were identified from an ongoing cohort study. Mean age of menopause between these two groups were calculated and compared. Multivariable linear regression was used to estimate the relationship between the status of the arsenic skin lesions and age of natural menopause in women. Women with arsenic skin lesions were 1.5 years younger (p <0.001) at the time of menopause compared to those without arsenic skin lesions. After adjusting with contraceptive use, body mass index, urinary arsenic level and family history of premature menopause, the difference between the groups' age at menopause was 2.1 years earlier (p <0.001) for respondents with arsenic skin lesions. The study showed a statistically significant association between chronic exposure to arsenic and age at menopause. Heavily exposed women experienced menopause two years earlier than those with lower or no exposure.

The viability of transplanting organs from donors who underwent cardiopulmonary resuscitation: A systematic review.

PubMed

West, Stephen; Soar, Jasmeet; Callaway, Clifton W

2016-11-01

To identify reports of patients who underwent cardiopulmonary resuscitation (CPR) prior to solid organ donation and compare recipient and organ function outcomes to those that did not undergo CPR. Donation after restoration of circulation then progressing to death and those donating with on-going CPR who would have otherwise have termination of efforts were both included. Systematic review. Clinical studies comparing the outcome of patients and organs retrieved from donors who underwent CPR with those that did not require CPR. Full-text articles were searched on EmBASE, MEDLINE, Cochrane Database of Systematic Reviews and the Cochrane Register of Controlled Trials. Twenty-two observational studies were included. There were 12,206 adult and 2552 paediatric organ transplantation identified. Comparing donation after restoration of circulation there was no difference in immediate, one year, and five-year graft function. Donation with on-going CPR was associated with reduced immediate graft function for both renal and hepatic transplantation, however long term function was not different. CPR does not appear to adversely affect graft function. Patients who have restored circulation after resuscitation and subsequently progress to death should be evaluated for organ donation. Those with on-going CPR should be considered for hepatic and renal transplantation but there may be worse initial graft function. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Medical Surveillance Monthly Report (MSMR). Volume 3, Number 7, October 1997

DTIC Science & Technology

1997-10-01

main and satellite clinics. Not all sites reporting. Date of Report: 7-Oct-97 ** Other STDs: (a) Chancroid (b) Granuloma Inguinale (c) Lymphogranuloma ... Venereum (d) Syphilis unspec. (e) Syph, tertiary (f) Syph, congenital § Includes participants in a large-scale ongoing chlamydia study (females only... Lymphogranuloma Vnrm 12 14 1 27 Yellow fever 0 0 0 0 Total 2320 2357 2468 7145 * Based on date of onset. Date of report: 7-Oct-97 MSMRVol. 03

Development of Novel Combinatorial Treatment to Prevent Chemotherapeutic Resistance and Enhance Efficacy of Riluzole in a Rodent Model of SCI

DTIC Science & Technology

2016-10-01

site as well as in the cervical and lumbar cords out to at least 10 months post-injury. While our rodent study was ongoing, a multi-center clinical...lead to a preservation of motor function and an attenuation in long-term pathologies like neuropathic pain in rats following an acute therapeutic...chemotherapeutic resistance, mass spectrometry, riluzole, licofelone, neuropathic pain , locomotor, bioavailability 11 University of Mississippi

Research strategies that result in optimal data collection from the patient medical record

PubMed Central

Gregory, Katherine E.; Radovinsky, Lucy

2010-01-01

Data obtained from the patient medical record are often a component of clinical research led by nurse investigators. The rigor of the data collection methods correlates to the reliability of the data and, ultimately, the analytical outcome of the study. Research strategies for reliable data collection from the patient medical record include the development of a precise data collection tool, the use of a coding manual, and ongoing communication with research staff. PMID:20974093

Investigational drugs for coagulation disorders.

PubMed

Mannucci, Pier Mannuccio; Mancuso, Maria Elisa

2013-08-01

The current standard treatment in persons with hemophilia (PWH) is prophylaxis, given intravenously twice or thrice weekly, which is associated with a non negligible burden on patients' quality of life. Therefore the main attempts aiming to improve the management of PWH are targeted towards the development of a new generation of coagulation factors endowed with properties facilitating prophylaxis and/or a better control of bleeding. This article summarizes the main results obtained so far in the development of new antihemophilic products, and emphasizes the formidable requirements imposed upon by regulatory agencies to get marketing authorization for new drugs, which make progress in this field difficult. Published literature on new molecules for replacement treatment in hemophilia A and B has been retrieved by using PubMed search and all ongoing clinical trials have been looked for online. New molecules are usually engineered to have a longer plasma half-life but also in some instances a higher potency. The prolongation of half-life may be obtained by using sustained release delivery vehicles, by chemical modification or by creating fusion proteins. Factors VIII, IX and VII have been variably modified in order to obtain improved coagulation products and results from Phase I/II studies are encouraging, particularly for factor IX. However, Phase III studies that should provide evidence on efficacy and effectiveness more cogent for clinical use are still ongoing and results are not yet available.

Driving CAR T-cells forward.

PubMed

Jackson, Hollie J; Rafiq, Sarwish; Brentjens, Renier J

2016-06-01

The engineered expression of chimeric antigen receptors (CARs) on the surface of T cells enables the redirection of T-cell specificity. Early clinical trials using CAR T cells for the treatment of patients with cancer showed modest results, but the impressive outcomes of several trials of CD19-targeted CAR T cells in the treatment of patients with B-cell malignancies have generated an increased enthusiasm for this approach. Important lessons have been derived from clinical trials of CD19-specific CAR T cells, and ongoing clinical trials are testing CAR designs directed at novel targets involved in haematological and solid malignancies. In this Review, we discuss these trials and present strategies that can increase the antitumour efficacy and safety of CAR T-cell therapy. Given the fast-moving nature of this field, we only discuss studies with direct translational application currently or soon-to-be tested in the clinical setting.

Driving CAR T-cells forward

PubMed Central

Jackson, Hollie J.; Rafiq, Sarwish; Brentjens, Renier J.

2017-01-01

The engineered expression of chimeric antigen receptors (CARs) on the surface of T cells enables the redirection of T-cell specificity. Early clinical trials using CAR T cells for the treatment of patients with cancer showed modest results, but the impressive outcomes of several trials of CD19-targeted CAR T cells in the treatment of patients with B-cell malignancies have generated an increased enthusiasm for this approach. Important lessons have been derived from clinical trials of CD19-specific CAR T cells, and ongoing clinical trials are testing CAR designs directed at novel targets involved in haematological and solid malignancies. In this Review, we discuss these trials and present strategies that can increase the antitumour efficacy and safety of CAR T-cell therapy. Given the fast-moving nature of this field, we only discuss studies with direct translational application currently or soon-to-be tested in the clinical setting. PMID:27000958

Refining the structure and content of clinical genomic reports.

PubMed

Dorschner, Michael O; Amendola, Laura M; Shirts, Brian H; Kiedrowski, Lesli; Salama, Joseph; Gordon, Adam S; Fullerton, Stephanie M; Tarczy-Hornoch, Peter; Byers, Peter H; Jarvik, Gail P

2014-03-01

To effectively articulate the results of exome and genome sequencing we refined the structure and content of molecular test reports. To communicate results of a randomized control trial aimed at the evaluation of exome sequencing for clinical medicine, we developed a structured narrative report. With feedback from genetics and non-genetics professionals, we developed separate indication-specific and incidental findings reports. Standard test report elements were supplemented with research study-specific language, which highlighted the limitations of exome sequencing and provided detailed, structured results, and interpretations. The report format we developed to communicate research results can easily be transformed for clinical use by removal of research-specific statements and disclaimers. The development of clinical reports for exome sequencing has shown that accurate and open communication between the clinician and laboratory is ideally an ongoing process to address the increasing complexity of molecular genetic testing. © 2014 Wiley Periodicals, Inc.

Outcome Measures in Myasthenia Gravis: Incorporation Into Clinical Practice.

PubMed

Muppidi, Srikanth

2017-03-01

The development of validated assessment tools for evaluating disease status and response to interventions in patients with myasthenia gravis (MG) has been driven by clinical studies of emerging MG therapies. However, only a small proportion of MG-focused neurology practices have adopted these assessment tools for routine clinical use. This article reviews the suitability of 5 assessment instruments for incorporation into clinical practice, which should be driven by their ability to contribute to improved patient outcomes, and to be implemented within practice personnel and resource constraints. It is recommended that assessments based on both physician-evaluated and patient-reported outcomes be selected, to adequately evaluate both point-in-time symptom load and functional impact of MG symptoms over time. Provider resource allocation and reimbursement issues may be the most significant roadblocks to successful ongoing use of these tools; to that end, the addition of regular assessments to MG standards of care is recommended.

Games in clinical genetic counseling supervision.

PubMed

McIntosh, Nathalie; Dircks, Anita; Fitzpatrick, Jennifer; Shuman, Cheryl

2006-08-01

Games are defined as ongoing series of complementary ulterior transactions that are superficially plausible but have a concealed motivation to maximize pay-offs and minimize penalties for the initiator. While some games are harmless and part of socialization, others are destructive. Destructive game-playing in clinical supervision, in which game-playing (initiated by either supervisors or students) interferes with a student's realization of internship goals, has been documented in some allied healthcare professions but has not yet been studied in genetic counseling. Genetic counselors and clinical supervisors of genetic counseling students were anonymously surveyed regarding their experiences with destructive game-playing. Results show that such games do occur in genetic counseling clinical supervision. Some games are the same or similar to ones previously described in other health-care professions; others may be unique to genetic counseling. The purpose of this paper is to document these games as a first step to facilitating dialogue, understanding and awareness of them.

Overview of the Oral HIV/AIDS Research Alliance Program

PubMed Central

Shiboski, C.H.; Webster-Cyriaque, J.Y.; Ghannoum, M.; Greenspan, J.S.; Dittmer, D.

2011-01-01

The Oral HIV/AIDS Research Alliance is part of the AIDS Clinical Trials Group, the largest HIV clinical trial organization in the world, and it is funded by the National Institute of Dental and Craniofacial Research, in collaboration with the National Institute of Allergy and Infectious Diseases. The alliance’s main objective is to investigate the oral complications associated with HIV/AIDS as the epidemic is evolving—in particular, the effects of potent antiretrovirals on the development of oral mucosal lesions and associated fungal and viral pathogens. Furthermore, oral fluids are being explored for their potential monitoring and diagnostic role with respect to HIV disease and coinfections. This article presents an overview of the alliance, its scientific agenda, and an outline of the novel interventional and noninterventional clinical studies ongoing and developing within the AIDS Clinical Trials Group infrastructure in the United States and internationally. PMID:21441477

Refining the Structure and Content of Clinical Genomic Reports

PubMed Central

DORSCHNER, MICHAEL O.; AMENDOLA, LAURA M.; SHIRTS, BRIAN H.; KIEDROWSKI, LESLI; SALAMA, JOSEPH; GORDON, ADAM S.; FULLERTON, STEPHANIE M.; TARCZY-HORNOCH, PETER; BYERS, PETER H.; JARVIK, GAIL P.

2014-01-01

To effectively articulate the results of exome and genome sequencing we refined the structure and content of molecular test reports. To communicate results of a randomized control trial aimed at the evaluation of exome sequencing for clinical medicine, we developed a structured narrative report. With feedback from genetics and non-genetics professionals, we developed separate indication-specific and incidental findings reports. Standard test report elements were supplemented with research study-specific language, which highlighted the limitations of exome sequencing and provided detailed, structured results, and interpretations. The report format we developed to communicate research results can easily be transformed for clinical use by removal of research-specific statements and disclaimers. The development of clinical reports for exome sequencing has shown that accurate and open communication between the clinician and laboratory is ideally an ongoing process to address the increasing complexity of molecular genetic testing. PMID:24616401

Overview of the oral HIV/AIDS Research Alliance Program.

PubMed

Shiboski, C H; Webster-Cyriaque, J Y; Ghannoum, M; Greenspan, J S; Dittmer, D

2011-04-01

The Oral HIV/AIDS Research Alliance is part of the AIDS Clinical Trials Group, the largest HIV clinical trial organization in the world, and it is funded by the National Institute of Dental and Craniofacial Research, in collaboration with the National Institute of Allergy and Infectious Diseases. The alliance's main objective is to investigate the oral complications associated with HIV/AIDS as the epidemic is evolving-in particular, the effects of potent antiretrovirals on the development of oral mucosal lesions and associated fungal and viral pathogens. Furthermore, oral fluids are being explored for their potential monitoring and diagnostic role with respect to HIV disease and coinfections. This article presents an overview of the alliance, its scientific agenda, and an outline of the novel interventional and noninterventional clinical studies ongoing and developing within the AIDS Clinical Trials Group infrastructure in the United States and internationally.

Intraoperative Clinical Decision Support for Anesthesia: A Narrative Review of Available Systems.

PubMed

Nair, Bala G; Gabel, Eilon; Hofer, Ira; Schwid, Howard A; Cannesson, Maxime

2017-02-01

With increasing adoption of anesthesia information management systems (AIMS), there is growing interest in utilizing AIMS data for intraoperative clinical decision support (CDS). CDS for anesthesia has the potential for improving quality of care, patient safety, billing, and compliance. Intraoperative CDS can range from passive and post hoc systems to active real-time systems that can detect ongoing clinical issues and deviations from best practice care. Real-time CDS holds the most promise because real-time alerts and guidance can drive provider behavior toward evidence-based standardized care during the ongoing case. In this review, we describe the different types of intraoperative CDS systems with specific emphasis on real-time systems. The technical considerations in developing and implementing real-time CDS are systematically covered. This includes the functional modules of a CDS system, development and execution of decision rules, and modalities to alert anesthesia providers concerning clinical issues. We also describe the regulatory aspects that affect development, implementation, and use of intraoperative CDS. Methods and measures to assess the effectiveness of intraoperative CDS are discussed. Last, we outline areas of future development of intraoperative CDS, particularly the possibility of providing predictive and prescriptive decision support.

Telemedicine Support Groups for Home Parenteral Nutrition Users.

PubMed

Nelson, Eve-Lynn; Yadrich, Donna Macan; Thompson, Noreen; Wright, Shawna; Stone, Kathaleen; Adams, Natasia; Werkowitch, Marilyn; Smith, Carol E

2017-12-01

Patients receiving home parenteral nutrition (HPN), a life-sustaining intravenous (IV) infusion that provides nourishment and hydration to patients with short gut or inflammatory bowel diseases, are often isolated and not in visual contact with peers or health providers. One completed clinical trial (Clinical Trials.gov NCT0190028) and 1 ongoing clinical trial (Clinical Trials.gov NCT02987569) are evaluating a mobile videoconferencing-delivered support group intervention for patients on HPN and their caregivers. This home-based telemedicine intervention uses encrypted tablet-based videoconferencing to connect multiple families in real time. The twice-daily IV regimen is challenging for patients who may experience infusion catheter-related bloodstream infections, difficulties with fatigue, loss of sleep, depressive disorders, and worry over the potential life-threatening side effects and the expenses of this therapy. Using secure telemedicine, the facilitated support group intervention aims to enhance HPN home care, daily functioning, and quality of life. The authors provide the rationale for the telemedicine approach with HPN users and caregivers. They provide "how-to" information about the content and process of the facilitated support group sessions via secure videoconferencing. They share lessons learned from the ongoing evaluation of the telemedicine approach.

06. Facilitating Collection of Research and Quality Data in Integrative Medicine Clinical Settings: Views From Academic, Health System and Private Clinics

PubMed Central

Dolor, Rowena; Victorson, David; Amoils, Steve

2013-01-01

Focus Areas: Integrative Approaches to Care The purpose of this panel discussion is to share successful efforts from a practice-based research network (PBRN) including ten integrative medicine clinics. The BraveNet PBRN includes integrative medicine clinics with academic health centers, large health systems, and a stand-alone private practice clinic. While clinical care is prioritized across all of these centers, introducing research into clinical sites oriented to providing care poses challenges that vary by clinic environment. We will highlight some of the unique issues encountered when trying to standardize data collection in sites practicing a patient-centered, whole-systems approach to healing as well as the solutions used to overcome these issues. We will present some operational solutions and data collected from the PBRN's ongoing data registry, entitled PRIMIER. The panel will engage attendees in a dialogue centering on potential for future analyses of existing results, ideas for possible upcoming studies, and creative ways to expand the PBRN data registry to include additional sites that may have expertise and interest in participating.

An assessment of the utilization of the preclinical rodent model literature in clinical trials of putative therapeutics for the treatment of alcohol use disorders.

PubMed

Barajaz, Ashley M; Kliethermes, Christopher L

2017-12-01

Rodent models of Alcohol Use Disorders (AUD) are used extensively by preclinical researchers to develop new therapeutics for the treatment of AUD. Although these models play an important role in the development of novel, targeted therapeutics, their role in bringing therapeutics to clinical trials is unclear, as off-label use of existing medications not approved for the treatment of AUD is commonly seen in the clinic and clinical trials. In the current study, we used the Clinicaltrials.gov database to obtain a list of drugs that have been tested for efficacy in a clinical trial between 1997 and 2017. We then conducted a set of literature searches to determine which of the 98 unique drugs we identified had shown efficacy in a rodent model of an AUD prior to being tested in a clinical trial. We found that slightly less than half of the drugs tested in clinical trials (48%) had shown prior efficacy in any rodent model of an AUD, while the remaining 52% of drugs were used off-label, or in some cases, following non-published studies. This study raises the question of how clinical researchers incorporate results from preclinical studies in the decision to bring a drug to a clinical trial. Our results underscore the need for ongoing communication among preclinical and clinical researchers. Copyright © 2017 Elsevier B.V. All rights reserved.

77 FR 52135 - Advisory Committee on Homeless Veterans, Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-28

... an on-going assessment of the effectiveness of the policies, organizational structures, and services... patient privacy to conduct a site visit at the Donald J. Mitchell VA Outpatient Clinic, Griffiss Business...

Leadless cardiac pacemakers: present and the future.

PubMed

Chew, Derek S; Kuriachan, Vikas

2018-01-01

Pacing technology for many decades has been composed of a generator attached to leads that are usually transvenous. Recently, leadless pacemakers have been studied in clinical settings and now available for use in many countries. This includes the single-component Nanostim Leadless Cardiac Pacemaker and Micra Transcatheter Pacing System, as well as the multicomponent Wireless Stimulation Endocardial system. Clinical studies in single-component leadless pacing technology has shown that they can be successfully implanted with minimal complications. The follow-up studies also seem to confirm the findings from the initial clinical trials. These systems offer some advantages over a traditional pacing system comprised of a subcutaneous generator and transvenous leads. In many ways, these leadless systems are disruptive technologies that are changing the traditional pacemaker concept and preferred for some patients. Ongoing research is needed to better assess their long-term function, safety, and end-of-life strategies. In the future, multichamber leadless pacing is expected to be developed and perhaps obviating the need for transvenous leads and their associated complications.

Effects of acupuncture on rates of pregnancy and live birth among women undergoing in vitro fertilisation: systematic review and meta-analysis.

PubMed

Manheimer, Eric; Zhang, Grant; Udoff, Laurence; Haramati, Aviad; Langenberg, Patricia; Berman, Brian M; Bouter, Lex M

2008-03-08

To evaluate whether acupuncture improves rates of pregnancy and live birth when used as an adjuvant treatment to embryo transfer in women undergoing in vitro fertilisation. Systematic review and meta-analysis. Medline, Cochrane Central, Embase, Chinese Biomedical Database, hand searched abstracts, and reference lists. Review methods Eligible studies were randomised controlled trials that compared needle acupuncture administered within one day of embryo transfer with sham acupuncture or no adjuvant treatment, with reported outcomes of at least one of clinical pregnancy, ongoing pregnancy, or live birth. Two reviewers independently agreed on eligibility; assessed methodological quality; and extracted outcome data. For all trials, investigators contributed additional data not included in the original publication (such as live births). Meta-analyses included all randomised patients. Seven trials with 1366 women undergoing in vitro fertilisation were included in the meta-analyses. There was little clinical heterogeneity. Trials with sham acupuncture and no adjuvant treatment as controls were pooled for the primary analysis. Complementing the embryo transfer process with acupuncture was associated with significant and clinically relevant improvements in clinical pregnancy (odds ratio 1.65, 95% confidence interval 1.27 to 2.14; number needed to treat (NNT) 10 (7 to 17); seven trials), ongoing pregnancy (1.87, 1.40 to 2.49; NNT 9 (6 to 15); five trials), and live birth (1.91, 1.39 to 2.64; NNT 9 (6 to 17); four trials). Because we were unable to obtain outcome data on live births for three of the included trials, the pooled odds ratio for clinical pregnancy more accurately represents the true combined effect from these trials rather than the odds ratio for live birth. The results were robust to sensitivity analyses on study validity variables. A prespecified subgroup analysis restricted to the three trials with the higher rates of clinical pregnancy in the control group, however, suggested a smaller non-significant benefit of acupuncture (odds ratio 1.24, 0.86 to 1.77). Current preliminary evidence suggests that acupuncture given with embryo transfer improves rates of pregnancy and live birth among women undergoing in vitro fertilisation.

Point-of-Care Diagnostics for Niche Applications

PubMed Central

Cummins, Brian M.; Ligler, Frances S.; Walker, Glenn M.

2016-01-01

Point-of-care or point-of-use diagnostics are analytical devices that provide clinically relevant information without the need for a core clinical laboratory. In this review we define point-of-care diagnostics as portable versions of assays performed in a traditional clinical chemistry laboratory. This review discusses five areas relevant to human and animal health where increased attention could produce significant impact: veterinary medicine, space travel, sports medicine, emergency medicine, and operating room efficiency. For each of these areas, clinical need, available commercial products, and ongoing research into new devices are highlighted. PMID:26837054

Physician Satisfaction With Integrated Behavioral Health in Pediatric Primary Care.

PubMed

Hine, Jeffrey F; Grennan, Allison Q; Menousek, Kathryn M; Robertson, Gail; Valleley, Rachel J; Evans, Joseph H

2017-04-01

As the benefits of integrated behavioral health care services are becoming more widely recognized, this study investigated physician satisfaction with ongoing integrated psychology services in pediatric primary care clinics. Data were collected across 5 urban and 6 rural clinics and demonstrated the specific factors that physicians view as assets to having efficient access to a pediatric behavioral health practitioner. Results indicated significant satisfaction related to quality and continuity of care and improved access to services. Such models of care may increase access to care and reduce other service barriers encountered by individuals and their families with behavioral health concerns (ie, those who otherwise would seek services through referrals to traditional tertiary care facilities).

Deep molecular responses for treatment-free remission in chronic myeloid leukemia.

PubMed

Dulucq, Stéphanie; Mahon, Francois-Xavier

2016-09-01

Several clinical trials have demonstrated that some patients with chronic myeloid leukemia in chronic phase (CML-CP) who achieve sustained deep molecular responses on tyrosine kinase inhibitor (TKI) therapy can safely suspend therapy and attempt treatment-free remission (TFR). Many TFR studies to date have enrolled imatinib-treated patients; however, the feasibility of TFR following nilotinib or dasatinib has also been demonstrated. In this review, we discuss available data from TFR trials and what these data reveal about the molecular biology of TFR. With an increasing number of ongoing TFR clinical trials, TFR may become an achievable goal for patients with CML-CP. © 2016 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Treating Patients Who Strain the Research Psychotherapy Paradigm

PubMed Central

Markowitz, John C.; Kaplowitz, Matthew; Suh, Eun-Jung; Meehan, Kevin; Neria, Yuval; Jonker, Hanske; Rafaeli, Alexandra; Lovell, Karina

2013-01-01

Background Clinical trials of psychotherapy require diagnostic homogeneity, which implies a convergence of clinical presentations. Yet research study patients present diversely, and patients who do not fit a treatment paradigm may greatly complicate delivery of the study psychotherapy. The research literature has not addressed this issue. Methods The authors use case illustrations of three psychotherapies – Prolonged Exposure, Relaxation Therapy, and Interpersonal Psychotherapy – from an ongoing psychotherapy outcome trial of posttraumatic stress disorder to describe psychotherapeutic responses to complex, “atypical” patients who strain standard treatment paradigms. Results Therapists required flexibility, and occasionally deviations from strict protocol, in treating heterodox patients. Conclusions Such heterogeneity of presentation may have implications for psychotherapy outcome in research trials. Despite lack of discussion in the literature, many trials may face such issues. PMID:22759936

Ongoing contraception after use of emergency contraception from a specialist contraceptive service.

PubMed

Cameron, Sharon T; Glasier, Anna; Johnstone, Anne; Rae, Leanne

2011-10-01

A consultation for emergency contraception (EC) gives way to an opportunity to provide women with an ongoing effective method of contraception. A review of the case notes of women seeking EC from a large family planning clinic in Edinburgh, Scotland, was conducted to determine what percentage of women were provided with an effective method of ongoing contraception. Case notes of 460 women presenting for EC over a 2-year period were reviewed. Women were of mean age 26 years (range 15-49 years) and presented because they had used no contraception (47%), experienced condom failure (42%) or missed oral contraceptive pills (9%). Only 2% (n=11) were given an intrauterine device for EC. All women who had missed contraceptive pills prior to taking EC opted to continue this method. Only 23% (n=89) of women using no method or condoms at EC received supplies of an effective contraceptive method (pills, patch, injectable). Two thirds (n=263) of the women chose condoms for ongoing contraception. Research is required to develop strategies to improve the uptake of effective contraception after EC. Copyright © 2011 Elsevier Inc. All rights reserved.

Cost and efficacy comparison of in vitro fertilization and tubal anastomosis for women after tubal ligation

PubMed Central

Messinger, Lauren B.; Alford, Connie E.; Csokmay, John M.; Henne, Melinda B.; Mumford, Sunni L.; Segars, James H.; Armstrong, Alicia Y.

2016-01-01

Objective To compare cost and efficacy of tubal anastomosis to in vitro fertilization (IVF) in women who desired fertility after a tubal ligation. Design Cost-effectiveness analysis. Setting Not applicable. Patient(s) Not applicable. Intervention(s) Not applicable. Main Outcome Measure(s) Cost per ongoing pregnancy. Result(s) Cost per ongoing pregnancy for women after tubal anastomosis ranged from $16,446 to $223,482 (2014 USD), whereas IVF ranged from $32,902 to $111,679 (2014 USD). Across maternal age groups <35 and 35–40, years tubal anastomosis was more cost effective than IVF for ongoing pregnancy. Sensitivity analyses validated these findings across a wide range of ongoing pregnancy probabilities as well as costs per procedure. Conclusion(s) Tubal anastomosis was the most cost-effective approach for most women less than 41 years of age, whereas IVF was the most cost-effective approach for women aged ≥41 years who desired fertility after tubal ligation. A model was created that can be modified based on cost and success rates in individual clinics for improved patient counseling. PMID:26006734

Cost and efficacy comparison of in vitro fertilization and tubal anastomosis for women after tubal ligation.

PubMed

Messinger, Lauren B; Alford, Connie E; Csokmay, John M; Henne, Melinda B; Mumford, Sunni L; Segars, James H; Armstrong, Alicia Y

2015-07-01

To compare cost and efficacy of tubal anastomosis to in vitro fertilization (IVF) in women who desired fertility after a tubal ligation. Cost-effectiveness analysis. Not applicable. Not applicable. Not applicable. Cost per ongoing pregnancy. Cost per ongoing pregnancy for women after tubal anastomosis ranged from $16,446 to $223,482 (2014 USD), whereas IVF ranged from $32,902 to $111,679 (2014 USD). Across maternal age groups <35 and 35-40, years tubal anastomosis was more cost effective than IVF for ongoing pregnancy. Sensitivity analyses validated these findings across a wide range of ongoing pregnancy probabilities as well as costs per procedure. Tubal anastomosis was the most cost-effective approach for most women less than 41 years of age, whereas IVF was the most cost-effective approach for women aged ≥41 years who desired fertility after tubal ligation. A model was created that can be modified based on cost and success rates in individual clinics for improved patient counseling. Copyright © 2015 American Society for Reproductive Medicine. All rights reserved.

Vitamins in Pancreatic Cancer: A Review of Underlying Mechanisms and Future Applications12

PubMed Central

Davis-Yadley, Ashley H; Malafa, Mokenge P

2015-01-01

Although there is increasing evidence that vitamins influence pancreatic adenocarcinoma biology and carcinogenesis, a comprehensive review is lacking. In this study, we performed a PubMed literature search to review the anticancer mechanisms and the preclinical and clinical studies that support the development of the bioactive vitamins A, C, D, E, and K in pancreatic cancer intervention. Preclinical studies have shown promising results for vitamin A in pancreatic cancer prevention, with clinical trials showing intriguing responses in combination with immunotherapy. For vitamin C, preclinical studies have shown slower tumor growth rates and/or increased survival when used alone or in combination with gemcitabine, with clinical trials with this combination revealing decreased primary tumor sizes and improved performance status. Preclinical studies with vitamin D analogues have shown potent antiproliferative effects and repression of migration and invasion of pancreatic cancer cells, with a clinical trial showing increased time to progression when calciferol was added to docetaxel. For vitamin E, preclinical studies have shown that δ-tocotrienol and γ-tocotrienol inhibited tumor cell growth and survival and augmented gemcitabine activity. Early-phase clinical trials with δ-tocotrienol are ongoing. Vitamin K demonstrates activation of apoptosis and inhibition of cellular growth in pancreatic tumor cells; however, there are no clinical studies available for further evaluation. Although preclinical and clinical studies are encouraging, randomized controlled trials with endpoints based on insights gained from mechanistic and preclinical studies and early-phase clinical trials are required to determine the efficacy of bioactive vitamin interventions in pancreatic cancer. PMID:26567201

Vitamins in pancreatic cancer: a review of underlying mechanisms and future applications.

PubMed

Davis-Yadley, Ashley H; Malafa, Mokenge P

2015-11-01

Although there is increasing evidence that vitamins influence pancreatic adenocarcinoma biology and carcinogenesis, a comprehensive review is lacking. In this study, we performed a PubMed literature search to review the anticancer mechanisms and the preclinical and clinical studies that support the development of the bioactive vitamins A, C, D, E, and K in pancreatic cancer intervention. Preclinical studies have shown promising results for vitamin A in pancreatic cancer prevention, with clinical trials showing intriguing responses in combination with immunotherapy. For vitamin C, preclinical studies have shown slower tumor growth rates and/or increased survival when used alone or in combination with gemcitabine, with clinical trials with this combination revealing decreased primary tumor sizes and improved performance status. Preclinical studies with vitamin D analogues have shown potent antiproliferative effects and repression of migration and invasion of pancreatic cancer cells, with a clinical trial showing increased time to progression when calciferol was added to docetaxel. For vitamin E, preclinical studies have shown that δ-tocotrienol and γ-tocotrienol inhibited tumor cell growth and survival and augmented gemcitabine activity. Early-phase clinical trials with δ-tocotrienol are ongoing. Vitamin K demonstrates activation of apoptosis and inhibition of cellular growth in pancreatic tumor cells; however, there are no clinical studies available for further evaluation. Although preclinical and clinical studies are encouraging, randomized controlled trials with endpoints based on insights gained from mechanistic and preclinical studies and early-phase clinical trials are required to determine the efficacy of bioactive vitamin interventions in pancreatic cancer. © 2015 American Society for Nutrition.

Fluorescence In Situ Hybridization Probe Validation for Clinical Use.

PubMed

Gu, Jun; Smith, Janice L; Dowling, Patricia K

2017-01-01

In this chapter, we provide a systematic overview of the published guidelines and validation procedures for fluorescence in situ hybridization (FISH) probes for clinical diagnostic use. FISH probes-which are classified as molecular probes or analyte-specific reagents (ASRs)-have been extensively used in vitro for both clinical diagnosis and research. Most commercially available FISH probes in the United States are strictly regulated by the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the Centers for Medicare & Medicaid Services (CMS) the Clinical Laboratory Improvement Amendments (CLIA), and the College of American Pathologists (CAP). Although home-brewed FISH probes-defined as probes made in-house or acquired from a source that does not supply them to other laboratories-are not regulated by these agencies, they too must undergo the same individual validation process prior to clinical use as their commercial counterparts. Validation of a FISH probe involves initial validation and ongoing verification of the test system. Initial validation includes assessment of a probe's technical specifications, establishment of its standard operational procedure (SOP), determination of its clinical sensitivity and specificity, development of its cutoff, baseline, and normal reference ranges, gathering of analytics, confirmation of its applicability to a specific research or clinical setting, testing of samples with or without the abnormalities that the probe is meant to detect, staff training, and report building. Ongoing verification of the test system involves testing additional normal and abnormal samples using the same method employed during the initial validation of the probe.

A systematic review comparing sex differences in cognitive function in schizophrenia and in rodent models for schizophrenia, implications for improved therapeutic strategies.

PubMed

Leger, Marianne; Neill, Joanna C

2016-09-01

Sex is often overlooked in animal and human research. Cognitive impairment associated with schizophrenia (CIAS) remains an unmet clinical need, as current antipsychotic medication does not provide clinically meaningful improvements. One explanation could be lack of appreciation of gender differences in CIAS. Animal models play a critical role in drug development and improved translation to the clinic is an on-going process. Our systematic review aims to evaluate how well the animal studies translate into clinical findings. Supporting clinical results, our review highlights a male working memory advantage and a female advantage for visual memory and social cognition in rodent models for schizophrenia. Not investigated in animals, a female advantage for attention and speed of processing has been found in schizophrenia patients. Sex differences in reasoning and problem solving are poorly investigated in both human and animal studies. Overall, our review provides evidence of good translation from the animal models into the clinic when sexual dimorphism is assessed. Enhanced understanding of these sex differences will improve the management of CIAS. Copyright © 2016 Elsevier Ltd. All rights reserved.

Implementing Single Source: The STARBRITE Proof-of-Concept Study

PubMed Central

Kush, Rebecca; Alschuler, Liora; Ruggeri, Roberto; Cassells, Sally; Gupta, Nitin; Bain, Landen; Claise, Karen; Shah, Monica; Nahm, Meredith

2007-01-01

Objective Inefficiencies in clinical trial data collection cause delays, increase costs, and may reduce clinician participation in medical research. In this proof-of-concept study, we examine the feasibility of using point-of-care data capture for both the medical record and clinical research in the setting of a working clinical trial. We hypothesized that by doing so, we could increase reuse of patient data, eliminate redundant data entry, and minimize disruption to clinic workflow. Design We developed and used a point-of-care electronic data capture system to record data during patient visits. The standards-based system was used for clinical research and to generate the clinic note for the medical record. The system worked in parallel with data collection procedures already in place for an ongoing multicenter clinical trial. Our system was iteratively designed after analyzing case report forms and clinic notes, and observing clinic workflow patterns and business procedures. Existing data standards from CDISC and HL7 were used for database insertion and clinical document exchange. Results Our system was successfully integrated into the clinic environment and used in two live test cases without disrupting existing workflow. Analyses performed during system design yielded detailed information on practical issues affecting implementation of systems that automatically extract, store, and reuse healthcare data. Conclusion Although subject to the limitations of a small feasibility study, our study demonstrates that electronic patient data can be reused for prospective multicenter clinical research and patient care, and demonstrates a need for further development of therapeutic area standards that can facilitate researcher use of healthcare data. PMID:17600107

Imaging in conjunction with physical therapy in management of a patient with history of thoracic tumour

PubMed Central

Rendeiro, Daniel G.; Deyle, Gail D.; Boissonnault, William G.

2015-01-01

Background: Physical therapy care for musculoskeletal conditions includes an ongoing process that systematically considers and prioritises diagnostic hypotheses. These diagnostic hypotheses include those that are typical for common musculoskeletal conditions, and must also include more rare conditions that would require care outside the scope of practice of the physical therapist. When additional screening is required, physical therapists collaborate with other providers or directly order the appropriate tests to rule out suspected pathology. Case Description: This article illustrates the use of musculoskeletal imaging ordered by a physical therapist to guide ongoing management of a patient with back pain and a history of cancer. Outcomes: The patient successfully returned to moderate-intensity sport activities after a course of physical therapy. Discussion: This case provides an example of how clinical diagnostic reasoning combined with clinical privileges to order musculoskeletal imaging can facilitate diagnostic accuracy in a timely and cost-efficient manner. PMID:26309382

Obesity, cardiovascular disease and type 2 diabetes in people with a mental illness: a need for primary health care.

PubMed

Stanley, Susanne H; Laugharne, Jonathan D E

2012-01-01

People with a mental illness show a growing incidence of obesity, and higher rates of metabolic syndrome when compared with the general population. This paper reviews research on obesity, cardiovascular disease and type 2 diabetes, with the aim of directing clinical attention towards the improvement of patient physical health. A systematic search of cross-discipline databases and journals provided peer-reviewed research for analysis, and national statistics allowed for the investigation of differences in rates of occurrence between people experiencing a mental illness and the general population. Treatment effects via psychotropic medications and lifestyle factors such as poor diet and low levels of exercise suggest that ongoing monitoring is necessary to prevent major physical disorders in people experiencing a mental illness. To aid clinicians, a comprehensive set of clinical guidelines have been developed for the physical assessment and ongoing monitoring of mental health patients.

Pazopanib therapy for cerebellar hemangioblastomas in von Hippel–Lindau disease

PubMed Central

Kim, Betty Y. S.; Jonasch, Eric

2016-01-01

von Hippel–Lindau (VHL) disease is a genetically acquired multisystem tumor syndrome of the viscera and central nervous system (CNS). The most common tumors associated with this disease are histologically benign, slow-growing CNS hemangioblastomas affecting the retina, cerebellum, brainstem, spinal cord or nerve roots. With mean age at diagnosis of 30 years, CNS hemangioblastomas are usually the first manifestation of the disease. Ongoing clinical and radiological surveillance is required, with symptomatic lesions necessitating treatment. As tumor growth is inevitable during the lifetime of most VHL patients, and the multiplicity of tumors may preclude surgical cure, the search for effective therapies is ongoing. Here we provide the first report demonstrating clinical and radiological anti-tumor response using pazopanib, a small molecule multi-receptor tyrosine kinase inhibitor, in a patient with treatment-refractory VHL-associated CNS hemangioblastoma. Treatment initiation with daily oral pazopanib (800 mg/day) resulted in significant neurologic improvement and radiologic tumor volume reduction. PMID:22374327

Germline determinants of clinical outcome of cutaneous melanoma

PubMed Central

Vogelsang, Matjaz; Wilson, Melissa; Kirchhoff, Tomas

2016-01-01

Cutaneous melanoma (CM) is the most lethal form of skin cancer. Despite the constant increase of melanoma incidence, which is in part due to incremental advances in early diagnostic modalities, mortality rates have not improved over the last decade and for advanced stages remain steadily high. While conventional prognostic biomarkers currently in use find significant utility for predicting overall general survival probabilities, they are not sensitive enough for a more personalized clinical assessment on an individual level. In recent years, the advent of genomic technologies has brought the promise of identification of germline DNA alterations that may associate with CM outcomes and hence represent novel biomarkers for clinical utilization. This review attempts to summarize the current state of knowledge of germline genetic factors studied for their impact on melanoma clinical outcomes. We also discuss ongoing problems and hurdles in validating such surrogates, and we also project future directions in discovery of more powerful germline genetic factors with clinical utility in melanoma prognostication. PMID:26342156

Linear Combinations of Multiple Outcome Measures to Improve the Power of Efficacy Analysis ---Application to Clinical Trials on Early Stage Alzheimer Disease

PubMed Central

Xiong, Chengjie; Luo, Jingqin; Morris, John C; Bateman, Randall

2018-01-01

Modern clinical trials on Alzheimer disease (AD) focus on the early symptomatic stage or even the preclinical stage. Subtle disease progression at the early stages, however, poses a major challenge in designing such clinical trials. We propose a multivariate mixed model on repeated measures to model the disease progression over time on multiple efficacy outcomes, and derive the optimum weights to combine multiple outcome measures by minimizing the sample sizes to adequately power the clinical trials. A cross-validation simulation study is conducted to assess the accuracy for the estimated weights as well as the improvement in reducing the sample sizes for such trials. The proposed methodology is applied to the multiple cognitive tests from the ongoing observational study of the Dominantly Inherited Alzheimer Network (DIAN) to power future clinical trials in the DIAN with a cognitive endpoint. Our results show that the optimum weights to combine multiple outcome measures can be accurately estimated, and that compared to the individual outcomes, the combined efficacy outcome with these weights significantly reduces the sample size required to adequately power clinical trials. When applied to the clinical trial in the DIAN, the estimated linear combination of six cognitive tests can adequately power the clinical trial. PMID:29546251

Sportsman hernia; the review of current diagnosis and treatment modalities.

PubMed

Paksoy, Melih; Sekmen, Ümit

2016-01-01

Groin pain is an important clinical entity that may affect a sportsman's active sports life. Sportsman's hernia is a chronic low abdominal and groin pain syndrome. Open and laparoscopic surgical treatment may be chosen in case of conservative treatment failure. Studies on sportsman's hernia, which is a challenging situation in both diagnosis and treatment, are ongoing in many centers. We reviewed the treatment results of 37 patients diagnosed and treated as sportsman's hernia at our hospital between 2011-2014, in light of current literature.

High-Frequency Percussive Ventilation in Patients with Inhalation Injury

DTIC Science & Technology

1989-01-01

inhalation injury. 21). High-frequency ventilation has been shown to be ef- METHODS fective in several clinical and laboratory trials ( 1 -3, 6-8, 17). The...Bear II or Seimens 900C ventilator. In each case the ability to 1 4 Male 43.5 18 Pneumonia maintain normocapnia or an arterial 0, saturation of greater...42.5 1 Group II consists cf the first ten patients who were enrolled 4 1 Female 59 11 Pneumonia in an ongoing prospective study of the use of high

Medical Surveillance Monthly Report (MSMR). Volume 4, Number 1, January 1998

DTIC Science & Technology

1998-01-01

and satellite clinics. Not all sites reporting. Date of Report: 7-Jan-98 ** Other STDs: (a) Chancroid (b) Granuloma Inguinale (c) Lymphogranuloma ... Venereum (d) Syphilis unspec. (e) Syph, tertiary (f) Syph, congenital § Includes participants in a large-scale ongoing chlamydia study (females only...only 63 34 25 12 134 Lymphogranuloma Vnrm 12 15 1 2 30 Yellow fever 0 0 0 0 0 Total 2342 2408 2864 1929 9543 * Based on date of onset. Date of

Characterization of the dengue outbreak in Nuevo Leon state, Mexico, 2010.

PubMed

Leduc-Galindo, D; Gloria-Herrera, U; Rincón-Herrera, U; Ramos-Jiménez, J; Garcia-Luna, S; Arellanos-Soto, D; Mendoza-Tavera, N; Tavitas-Aguilar, I; Garcia-Garcia, E; Galindo-Galindo, E; Villarreal-Perez, J; Fernandez-Salas, I; Santiago, G A; Muñoz-Jordan, J; Rivas-Estilla, A M

2015-04-01

We studied serotypes circulating dengue virus (DENV) cases, entomological Breteau index, rain-fall index and epidemiology of groups affected during the 2010 outbreak in Nuevo Leon, Mexico. From 2,271 positive cases, 94% were dengue classic and 6% dengue hemorrhagic fever; DENV1 was mainly isolated (99%) (Central-American lineage of American-African-genotype). We found correlation between two environmental phenomena (Increment of rainfall and vector-indexes) (p ≤ 0.05) with epidemiological, clinical and risk of DENV-1 ongoing transmission.

Proposal for Development of EBM-CDSS (Evidence-Based Clinical Decision Support System) to Aid Prognostication in Terminally Ill Patients

DTIC Science & Technology

2013-10-01

monthly basis. The similar process is followed at TGH, where the research team mostly works with palliative care service. Through this process, the... Palliative Care at TGH. • We continue to regularly conduct meetings with TGH palliative care team and present the ongoing experience of our research study...to the TGH palliative care team. These meeting established a fruitful and trustful and working relationship with TGH palliative care team, which is

Intracellular sodium hydrogen exchange inhibition and clinical myocardial protection.

PubMed

Mentzer, Robert M; Lasley, Robert D; Jessel, Andreas; Karmazyn, Morris

2003-02-01

Although the mechanisms underlying ischemia/reperfusion injury remain elusive, evidence supports the etiologic role of intracellular calcium overload and oxidative stress induced by reactive oxygen species. Activation of the sodium hydrogen exchanger (NHE) is associated with intracellular calcium accumulation. Inhibition of the NHE-1 isoform may attenuate the consequences of this injury. Although there is strong preclinical and early clinical evidence that NHE inhibitors may be cardioprotective, definitive proof of this concept in humans awaits the results of ongoing clinical trials.

Periodontal disease and rheumatoid arthritis: the evidence accumulates for complex pathobiologic interactions

PubMed Central

Bingham, Clifton O.; Moni, Malini

2015-01-01

Purpose of review This review was conducted to focus on the recent clinical and translational research related to the associations between periodontal disease and rheumatoid arthritis. Recent findings There is a growing interest in the associations between oral health and autoimmune and inflammatory diseases. A number of epidemiologic studies have described associations between rheumatoid arthritis and periodontal disease. Recent clinical studies continue to support these reports, and are increasingly linked with biological assessments to better understand the nature of these relationships. A number of recent studies have evaluated the periopathogenic roles of Porphyromonas gingivalis, the oral microbiome, and mechanisms of site-specific and substrate-specific citrullination. These are helping to further elucidate the interactions between these two inflammatory disease processes. Summary Studies of clinical oral health parameters, the gingival microenvironment, autoantibodies and biomarkers, and rheumatoid arthritis disease activity measures are providing a better understanding of the potential mechanisms responsible for rheumatoid arthritis and periodontal disease associations. The cumulative results and ongoing studies have the promise to identify novel mechanisms and interventional strategies to improve patient outcomes for both conditions. PMID:23455329

Conceptualizing clinical nurse leader practice: an interpretive synthesis.

PubMed

Bender, Miriam

2016-01-01

The Institute of Medicine's Future of Nursing report identifies the clinical nurse leader as an innovative new role for meeting higher health-care quality standards. However, specific clinical nurse leader practices influencing documented quality outcomes remain unclear. Lack of practice clarity limits the ability to articulate, implement and measure clinical nurse leader-specific practice and quality outcomes. Interpretive synthesis design and grounded theory analysis were used to develop a theoretical understanding of clinical nurse leader practice that can facilitate systematic and replicable implementation across health-care settings. The core phenomenon of clinical nurse leader practice is continuous clinical leadership, which involves four fundamental activities: facilitating effective ongoing communication; strengthening intra and interprofessional relationships; building and sustaining teams; and supporting staff engagement. Clinical nurse leaders continuously communicate and develop relationships within and across professions to promote and sustain information exchange, engagement, teamwork and effective care processes at the microsystem level. Clinical nurse leader-integrated care delivery systems highlight the benefits of nurse-led models of care for transforming health-care quality. Managers can use this study's findings to frame an implementation strategy that addresses theoretical domains of clinical nurse leader practice to help ensure practice success. © 2015 John Wiley & Sons Ltd.

Cycle scheduling for in vitro fertilization with oral contraceptive pills versus oral estradiol valerate: a randomized, controlled trial

PubMed Central

2013-01-01

Background Both oral contraceptive pills (OCPs) and estradiol (E2) valerate have been used to schedule gonadotropin-releasing hormone (GnRH) antagonist in vitro fertilization (IVF) cycles and, consequently, laboratory activities. However, there are no studies comparing treatment outcomes directly between these two pretreatment methods. This randomized controlled trial was aimed at finding differences in ongoing pregnancy rates between GnRH antagonist IVF cycles scheduled with OCPs or E2 valerate. Methods Between January and May 2012, one hundred consecutive patients (nonobese, regularly cycling women 18–38 years with normal day 3 hormone levels and <3 previous IVF/ICSI attempts) undergoing IVF with the GnRH antagonist protocol were randomized to either the OCP or E2 pretreatment arms, with no restrictions such as blocking or stratification. Authors involved in data collection and analysis were blinded to group assignment. Fifty patients received OCP (30 μg ethinyl E2/150 μg levonorgestrel) for 12–16 days from day 1 or 2, and stimulation was started 5 days after stopping OCP. Similarly, 50 patients received 4 mg/day oral E2 valerate from day 20 for 5–12 days, until the day before starting stimulation. Results Pretreatment with OCP (mean±SD, 14.5±1.7 days) was significantly longer than with E2 (7.8±1.9 days). Stimulation and embryological characteristics were similar. Ongoing pregnancy rates (46.0% vs. 44.0%; risk difference, –2.0% [95% CI –21.2% to 17.3%]), as well as implantation (43.5% vs. 47.4%), clinical pregnancy (50.0% vs. 48.0%), clinical miscarriage (7.1% vs. 7.7%), and live birth (42.0% vs. 40.0%) rates were comparable between groups. Conclusions This is the first study to directly compare these two methods of cycle scheduling in GnRH antagonist cycles. Our results fail to show statistically significant differences in ongoing pregnancy rates between pretreatment with OCP and E2 for IVF with the GnRH antagonist protocol. Although the study is limited by its sample size, our results may contribute to a future meta-analysis. An interesting future direction would be to extend our study to women with decreased ovarian reserve, as these are the patients in whom an increase in oocyte yield—due to the hypothetical beneficial effect of steroid pretreatment on follicular synchronization—could more easily be demonstrated. Trial registration ClinicalTrials.gov http://NCT01501448. PMID:24074027

Effect of computer use on physician-patient communication using a validated instrument: Patient perspective.

PubMed

Shaarani, Issam; Taleb, Rim; Antoun, Jumana

2017-12-01

Physician-patient communication is essential in the physician-patient relationship. Concerns were raised about the impact of the computer on this relationship with the increase in use of electronic medical records (EMR). Most studies addressed the physician's perspective and only few explored the patient's perspective. This study aims to assess the patient's perspective of the effect of the physician's computer use during the clinical encounter on the interpersonal and communication skills of the physician using a validated communication assessment tool (CAT). This is a cross-sectional survey of three hundred eighty-two patients who visited the family medicine clinics (FMC) at the American University of Beirut Medical Center (AUBMC). At the end of the visit with the physician, the patients were approached by the clinical assistant to fill a paper-based questionnaire privately in the waiting room to measure communication skills of physicians using CAT. Nearly two-thirds of the patients (62%) did not consider that using the computer by their physician during the visit would negatively affect the patient-doctor communication. Patients rated their physician with a higher communication score when there was an ongoing relationship between the physician and the patient. Higher communication scores were reported for extensive use of the computer by the physician to check results (p<0.001), to retrieve patient record information (p<0.001) and to educate patients (p<0.001) as compared to less use. Physician-patient communication was not negatively affected by the physician use of the computer as rated by patients. An ongoing relationship with the physician remains a significant predictor of better physician-patient communication even in the presence of the computer. Copyright © 2017 Elsevier B.V. All rights reserved.

Predicting clinical trial results based on announcements of interim analyses

PubMed Central

2014-01-01

Background Announcements of interim analyses of a clinical trial convey information about the results beyond the trial’s Data Safety Monitoring Board (DSMB). The amount of information conveyed may be minimal, but the fact that none of the trial’s stopping boundaries has been crossed implies that the experimental therapy is neither extremely effective nor hopeless. Predicting success of the ongoing trial is of interest to the trial’s sponsor, the medical community, pharmaceutical companies, and investors. We determine the probability of trial success by quantifying only the publicly available information from interim analyses of an ongoing trial. We illustrate our method in the context of the National Surgical Adjuvant Breast and Bowel (NSABP) trial, C-08. Methods We simulated trials based on the specifics of the NSABP C-08 protocol that were publicly available. We quantified the uncertainty around the treatment effect using prior weights for the various possibilities in light of other colon cancer studies and other studies of the investigational agent, bevacizumab. We considered alternative prior distributions. Results Subsequent to the trial’s third interim analysis, our predictive probabilities were: that the trial would eventually be successful, 48.0%; would stop for futility, 7.4%; and would continue to completion without statistical significance, 44.5%. The actual trial continued to completion without statistical significance. Conclusions Announcements of interim analyses provide information outside the DSMB’s sphere of confidentiality. This information is potentially helpful to clinical trial prognosticators. ‘Information leakage’ from standard interim analyses such as in NSABP C-08 is conventionally viewed as acceptable even though it may be quite revealing. Whether leakage from more aggressive types of adaptations is acceptable should be assessed at the design stage. PMID:24607270

Role of music therapy in integrative oncology.

PubMed

Magill, Lucanne

2006-01-01

Music therapy is an evidence-based complementary therapy that enhances quality of life in cancer patients and their caregivers. The role of music therapy in integrative oncology encompassed care and treatment of patients and family members , ongoing collaboration with the health care team, and the provision of music therapy services that may benefit the cancer center community. Clinical work includes ongoing assessment and the implementation of specific music therapy techniques aimed at reducing challenging symptoms and enhancing overall well-being and quality of life. This article outlines music therapy methods and the role that the music therapist has in integrative oncology programs.

Development of Gene Therapy for Thalassemia

PubMed Central

Nienhuis, Arthur W.; Persons, Derek A.

2012-01-01

Retroviral vector–mediated gene transfer into hematopoietic stem cells provides a potentially curative therapy for severe β-thalassemia. Lentiviral vectors based on human immunodeficiency virus have been developed for this purpose and have been shown to be effective in curing thalassemia in mouse models. One participant in an ongoing clinical trial has achieved transfusion independence after gene transfer into bone marrow stem cells owing, in part, to a genetically modified, dominant clone. Ongoing efforts are focused on improving the efficiency of lentiviral vector–mediated gene transfer into stem cells so that the curative potential of gene transfer can be consistently achieved. PMID:23125203

Renaissance of antibiotics against difficult infections: Focus on oritavancin and new ketolides and quinolones.

PubMed

Van Bambeke, Françoise

2014-11-01

Lipoglycopeptide, ketolide, and quinolone antibiotics are currently in clinical development, with specific advantages over available molecules within their respective classes. The lipoglycopeptide oritavancin is bactericidal against MRSA, vancomycin-resistant enterococci, and multiresistant Streptococcus pneumoniae, and proved effective and safe for the treatment of acute bacterial skin and skin structure infection (ABSSSI) upon administration of a single 1200 mg dose (two completed phase III trials). The ketolide solithromycin (two phase III studies recruiting for community-acquired pneumonia) shows a profile of activity similar to that of telithromycin, but in vitro data suggest a lower risk of hepatotoxicity, visual disturbance, and aggravation of myasthenia gravis due to reduced affinity for nicotinic receptors. Among quinolones, finafloxacin and delafloxacin share the unique property of an improved activity in acidic environments (found in many infection sites). Finafloxacin (phase II completed; activity profile similar to that of ciprofloxacin) is evaluated for complicated urinary tract and Helicobacter pylori infections. The other quinolones (directed towards Gram-positive pathogens) show improved activity on MRSA and multiresistant S. pneumoniae compared to current molecules. They are in clinical evaluation for ABSSSI (avarofloxacin (phase II completed), nemonoxacin and delafloxacin (ongoing phase III)), respiratory tract infections (zabofloxacin and nemonoxacin (ongoing phase III)), or gonorrhea (delafloxacin).

Demographic, clinical and antibody characteristics of patients with digital ulcers in systemic sclerosis: data from the DUO Registry.

PubMed

Denton, Christopher P; Krieg, Thomas; Guillevin, Loic; Schwierin, Barbara; Rosenberg, Daniel; Silkey, Mariabeth; Zultak, Maurice; Matucci-Cerinic, Marco

2012-05-01

The Digital Ulcers Outcome (DUO) Registry was designed to describe the clinical and antibody characteristics, disease course and outcomes of patients with digital ulcers associated with systemic sclerosis (SSc). The DUO Registry is a European, prospective, multicentre, observational, registry of SSc patients with ongoing digital ulcer disease, irrespective of treatment regimen. Data collected included demographics, SSc duration, SSc subset, internal organ manifestations, autoantibodies, previous and ongoing interventions and complications related to digital ulcers. Up to 19 November 2010 a total of 2439 patients had enrolled into the registry. Most were classified as either limited cutaneous SSc (lcSSc; 52.2%) or diffuse cutaneous SSc (dcSSc; 36.9%). Digital ulcers developed earlier in patients with dcSSc compared with lcSSc. Almost all patients (95.7%) tested positive for antinuclear antibodies, 45.2% for anti-scleroderma-70 and 43.6% for anticentromere antibodies (ACA). The first digital ulcer in the anti-scleroderma-70-positive patient cohort occurred approximately 5 years earlier than the ACA-positive patient group. This study provides data from a large cohort of SSc patients with a history of digital ulcers. The early occurrence and high frequency of digital ulcer complications are especially seen in patients with dcSSc and/or anti-scleroderma-70 antibodies.

Atezolizumab for the treatment of colorectal cancer: the latest evidence and clinical potential.

PubMed

Tapia Rico, Gonzalo; Price, Timothy J

2018-04-01

Atezolizumab is a fully humanized, engineered monoclonal antibody that specifically targets PD-L1, key molecule in the cancer-immunity pathway. Atezolizumab is currently approved for the treatment of metastatic non-small-cell lung cancer and advanced urothelial carcinomas. Areas covered: In this review, we will present the available data supporting the efficacy of atezolizumab for the treatment of metastatic colorectal cancer (mCRC). We will also provide an update on the ongoing/future clinical trials evaluating the role of atezolizumab for the treatment of CRC in different settings (alone or in combination with other checkpoint inhibitors and/or targeted therapies). So far, a small subgroup of mCRC (those with deficiency in mismatch repair - dMMR) appears to benefit significantly from checkpoint inhibitors. As expected, further research is needed to develop biomarkers, effective therapeutic strategies and novel combinations to overcome immune escape resistance and achieve better responses with minimal toxicities. Expert opinion: Interim analyses from ongoing early-phase studies in mCRC have shown encouraging activity of atezolizumab in combination with chemotherapy and/or targeted therapies, especially with MEK inhibitor cobimetinib. Within the next few years, this PD-L1 checkpoint inhibitor will likely be included as one of the treatment options for CRC, at least for patients with dMMR.

Toward noninvasive monitoring of ongoing electrical activity of human uterus and fetal heart and brain.

PubMed

Lew, S; Hämäläinen, M S; Okada, Y

2017-12-01

To evaluate whether a full-coverage fetal-maternal scanner can noninvasively monitor ongoing electrophysiological activity of maternal and fetal organs. A simulation study was carried out for a scanner with an array of magnetic field sensors placed all around the torso from the chest to the hip within a horizontal magnetic shielding enclosure. The magnetic fields from internal organs and an external noise source were computed for a pregnant woman with a 35-week old fetus. Signal processing methods were used to reject the external and internal interferences, to visualize uterine activity, and to detect activity of fetal heart and brain. External interference was reduced by a factor of 1000, sufficient for detecting signals from internal organs when combined with passive and active shielding. The scanner rejects internal interferences better than partial-coverage arrays. It can be used to estimate currents around the uterus. It clearly detects spontaneous activity from the fetal heart and brain without averaging and weaker evoked brain activity at all fetal head positions after averaging. The simulated device will be able to monitor the ongoing activity of the fetal and maternal organs. This type of scanner may become a novel tool in fetal medicine. Copyright © 2017 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.

Adult mesenchymal stem cells and women's health.

PubMed

Caplan, Arnold I

2015-02-01

Adult mesenchymal stem cells (MSCs) were previously described as multipotent cells that could differentiate into bone, cartilage, muscle, and other mesenchymal tissues. New information suggests that MSCs can be found in every tissue of the body because they function as perivascular cells--pericytes--found outside all blood vessels. When these vessels break or are inflamed, pericytes are detached and form MSCs, which are activated by their local microenvironment of injury. Such MSCs function to secrete powerful immune-modulatory and regenerative agents; more than 450 clinical trials are now ongoing, covering a huge spectrum of clinical conditions. How such activated MSCs affect menstrual cycle, menopause, or osteotrophic cancers has only recently been studied. This article outlines these issues and challenges the scientific and medical community to use this newfound knowledge to uncover new clinical logics and medial solutions for women.

Advances in Aβ plaque detection and the value of knowing: overcoming challenges to improving patient outcomes in Alzheimer's disease.

PubMed

Jovalekic, Aleksandar; Bullich, Santiago; Catafau, Ana; de Santi, Susan

2016-12-01

Clinical diagnosis of Alzheimer's disease (AD) can be challenging as numerous diseases mimic the characteristics of AD. In this light, recent guidelines developed by different associations and working groups point out the need for biomarkers to support AD diagnosis. This paper discusses 18F-labeled radiotracers (which are indicated for PET imaging of the brain) and ongoing clinical studies that aim to generate new evidence for the usage of amyloid imaging. In addition to their relatively long half-life, these agents are known for their high sensitivity and high negative predictive values for detection of neuritic Aβ plaques. Comparisons with other biomarkers are provided and implications of diagnostic disclosures discussed. Finally, recent data from clinical trials underscore the importance of amyloid PET for detecting, quantifying and monitoring Aβ plaque deposits.

Biomagnetism using SQUIDs: status and perspectives

NASA Astrophysics Data System (ADS)

Sternickel, Karsten; Braginski, Alex I.

2006-03-01

Biomagnetism involves the measurement and analysis of very weak local magnetic fields of living organisms and various organs in humans. Such fields can be of physiological origin or due to magnetic impurities or markers. This paper reviews existing and prospective applications of biomagnetism in clinical research and medical diagnostics. Currently, such applications require sensitive magnetic SQUID sensors and amplifiers. The practicality of biomagnetic methods depends especially on techniques for suppressing the dominant environmental electromagnetic noise, and on suitable nearly real-time data processing and interpretation methods. Of the many biomagnetic methods and applications, only the functional studies of the human brain (magnetoencephalography) and liver susceptometry are in clinical use, while functional diagnostics of the human heart (magnetocardiography) approaches the threshold of clinical acceptance. Particularly promising for the future is the ongoing research into low-field magnetic resonance anatomical imaging using SQUIDs.

The role of barrier membranes for guided bone regeneration and restoration of large bone defects: current experimental and clinical evidence

PubMed Central

2012-01-01

Treatment of large bone defects represents a great challenge in orthopedic and craniomaxillofacial surgery. Although there are several methods for bone reconstruction, they all have specific indications and limitations. The concept of using barrier membranes for restoration of bone defects has been developed in an effort to simplify their treatment by offering a sinlge-staged procedure. Research on this field of bone regeneration is ongoing, with evidence being mainly attained from preclinical studies. The purpose of this review is to summarize the current experimental and clinical evidence on the use of barrier membranes for restoration of bone defects in maxillofacial and orthopedic surgery. Although there are a few promising preliminary human studies, before clinical applications can be recommended, future research should aim to establish the 'ideal' barrier membrane and delineate the need for additional bone grafting materials aiming to 'mimic' or even accelerate the normal process of bone formation. Reproducible results and long-term observations with barrier membranes in animal studies, and particularly in large animal models, are required as well as well-designed clinical studies to evaluate their safety, efficacy and cost-effectiveness. PMID:22834465

Role of Pharmacogenomics in the Management of Traditional and Novel Oral Anticoagulants

PubMed Central

Cavallari, Larisa H.; Shin, Jaekyu; Perera, Minoli A.

2013-01-01

Warfarin is the most commonly prescribed oral anticoagulant. However, it remains a difficult drug to manage mostly because of its narrow therapeutic index and wide interpatient variability in anticoagulant effects. Over the past decade, there has been substantial progress in our understanding of genetic contributions to variable warfarin response, particularly with regard to warfarin dose requirements. The genes encoding for cytochrome P450 (CYP) 2C9 (CYP2C9) and vitamin K epoxide reductase complex subunit 1 (VKORC1) are the major genetic determinants of warfarin pharmacokinetics and pharmacodynamics, respectively. Numerous studies have demonstrated significant contributions of these genes to warfarin dose requirements. The CYP2C9 gene has also been associated with bleeding risk with warfarin. The CYP4F2 gene influences vitamin K availability and makes minor contributions to warfarin dose requirements. Less is known about genes influencing warfarin response in African-American patients compared with other racial groups, but this is the focus of ongoing research. Several warfarin pharmacogenetic dosing algorithms and United States Food and Drug Administration–cleared genotyping tests are available for clinical use. Clinical trials are ongoing to determine the clinical utility and cost-effectiveness of genotype-guided warfarin dosing. Results from these trials will likely influence clinical uptake and third party payer reimbursement for genotype-guided warfarin therapy. There is still a lack of pharmacogenetic data for the newly approved oral anticoagulants, dabigatran and rivaroxaban, and with other oral anticoagulants in the research and development pipeline. These data, once known, could be of great importance as routine monitoring parameters for these agents are not available. PMID:22122181

A systematic review of the association between radiographic and clinical osteoarthritis of hip and knee.

PubMed

Kinds, M B; Welsing, P M J; Vignon, E P; Bijlsma, J W J; Viergever, M A; Marijnissen, A C A; Lafeber, F P J G

2011-07-01

There is ongoing debate on whether an association between radiographic and clinical osteoarthritis (OA) exists. We hypothesized that the inconsistency in the detection of an association might be caused by different definitions of OA, by different radiographic protocols, and by scoring methods for radiographic damage and symptoms. The goal of this study was to evaluate which methodological criteria are important to detect an association between radiographic and clinical OA of hip and knee. A literature search was performed with the keywords 'OA', 'hip', 'knee', 'radiographic', and 'clinical' and results were screened for relevant studies. Quality criteria for study characteristics and methodology were developed. Studies were classified according to these criteria and the presence of an association between radiographic and clinical OA was scored. The importance of methodological quality and patient characteristics on the presence of an association was evaluated. The literature search resulted in 39 studies describing an association between radiographic and clinical OA. The frequency of an association between radiographic and clinical OA outcome measures diminished when less quality criteria were fulfilled. Specifically the criterion for standardized outcome measures appeared important in the detection of an association. The association was not influenced by patient characteristics. Only four studies were identified that fulfilled all quality criteria and in these studies an association was found for the knee joint and an inconsistent association was found for the hip joint. Methodological quality criteria are of importance to reveal an association between radiographic and clinical OA. Copyright © 2011 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Developing a provisional, international minimal dataset for Juvenile Dermatomyositis: for use in clinical practice to inform research.

PubMed

McCann, Liza J; Arnold, Katie; Pilkington, Clarissa A; Huber, Adam M; Ravelli, Angelo; Beard, Laura; Beresford, Michael W; Wedderburn, Lucy R

2014-01-01

Juvenile dermatomyositis (JDM) is a rare but severe autoimmune inflammatory myositis of childhood. International collaboration is essential in order to undertake clinical trials, understand the disease and improve long-term outcome. The aim of this study was to propose from existing collaborative initiatives a preliminary minimal dataset for JDM. This will form the basis of the future development of an international consensus-approved minimum core dataset to be used both in clinical care and inform research, allowing integration of data between centres. A working group of internationally-representative JDM experts was formed to develop a provisional minimal dataset. Clinical and laboratory variables contained within current national and international collaborative databases of patients with idiopathic inflammatory myopathies were scrutinised. Judgements were informed by published literature and a more detailed analysis of the Juvenile Dermatomyositis Cohort Biomarker Study and Repository, UK and Ireland. A provisional minimal JDM dataset has been produced, with an associated glossary of definitions. The provisional minimal dataset will request information at time of patient diagnosis and during on-going prospective follow up. At time of patient diagnosis, information will be requested on patient demographics, diagnostic criteria and treatments given prior to diagnosis. During on-going prospective follow-up, variables will include the presence of active muscle or skin disease, major organ involvement or constitutional symptoms, investigations, treatment, physician global assessments and patient reported outcome measures. An internationally agreed minimal dataset has the potential to significantly enhance collaboration, allow effective communication between groups, provide a minimal standard of care and enable analysis of the largest possible number of JDM patients to provide a greater understanding of this disease. This preliminary dataset can now be developed into a consensus-approved minimum core dataset and tested in a wider setting with the aim of achieving international agreement.

Violent Recidivism: A Long-Time Follow-Up Study of Mentally Disordered Offenders

PubMed Central

Nilsson, Thomas; Wallinius, Märta; Gustavson, Christina; Anckarsäter, Henrik; Kerekes, Nóra

2011-01-01

Background In this prospective study, mentally disordered perpetrators of severe violent and/or sexual crimes were followed through official registers for 59 (range 8 to 73) months. The relapse rate in criminality was assessed, compared between offenders sentenced to prison versus forensic psychiatric care, and the predictive ability of various risk factors (criminological, clinical, and of structured assessment instruments) was investigated. Method One hundred perpetrators were consecutively assessed between 1998 and 2001 by a clinical battery of established instruments covering DSM-IV diagnoses, psychosocial background factors, and structured assessment instruments (HCR-20, PCL-R, and life-time aggression (LHA)). Follow-up data was collected from official registers for: (i) recidivistic crimes, (ii) crimes during ongoing sanction. Results Twenty subjects relapsed in violent criminality during ongoing sanctions (n = 6) or after discharge/parole (n = 14). Individuals in forensic psychiatric care spent significantly more time at liberty after discharge compared to those in prison, but showed significantly fewer relapses. Criminological (age at first conviction), and clinical (conduct disorder and substance abuse/dependence) risk factors, as well as scores on structured assessment instruments, were moderately associated with violent recidivism. Logistic regression analyses showed that the predictive ability of criminological risk factors versus clinical risk factors combined with scores from assessment instruments was comparable, with each set of variables managing to correctly classify about 80% of all individuals, but the only predictors that remained significant in multiple models were criminological (age at first conviction, and a history of substance abuse among primary relatives). Conclusions Only one in five relapsed into serious criminality, with significantly more relapses among subjects sentenced to prison as compared to forensic psychiatric care. Criminological risk factors tended to be the best predictors of violent relapses, while few synergies were seen when the risk factors were combined. Overall, the predictive validity of common risk factors for violent criminality was rather weak. PMID:22022445

Developing a provisional, international Minimal Dataset for Juvenile Dermatomyositis: for use in clinical practice to inform research

PubMed Central

2014-01-01

Background Juvenile dermatomyositis (JDM) is a rare but severe autoimmune inflammatory myositis of childhood. International collaboration is essential in order to undertake clinical trials, understand the disease and improve long-term outcome. The aim of this study was to propose from existing collaborative initiatives a preliminary minimal dataset for JDM. This will form the basis of the future development of an international consensus-approved minimum core dataset to be used both in clinical care and inform research, allowing integration of data between centres. Methods A working group of internationally-representative JDM experts was formed to develop a provisional minimal dataset. Clinical and laboratory variables contained within current national and international collaborative databases of patients with idiopathic inflammatory myopathies were scrutinised. Judgements were informed by published literature and a more detailed analysis of the Juvenile Dermatomyositis Cohort Biomarker Study and Repository, UK and Ireland. Results A provisional minimal JDM dataset has been produced, with an associated glossary of definitions. The provisional minimal dataset will request information at time of patient diagnosis and during on-going prospective follow up. At time of patient diagnosis, information will be requested on patient demographics, diagnostic criteria and treatments given prior to diagnosis. During on-going prospective follow-up, variables will include the presence of active muscle or skin disease, major organ involvement or constitutional symptoms, investigations, treatment, physician global assessments and patient reported outcome measures. Conclusions An internationally agreed minimal dataset has the potential to significantly enhance collaboration, allow effective communication between groups, provide a minimal standard of care and enable analysis of the largest possible number of JDM patients to provide a greater understanding of this disease. This preliminary dataset can now be developed into a consensus-approved minimum core dataset and tested in a wider setting with the aim of achieving international agreement. PMID:25075205

The costs associated with adverse event procedures for an international HIV clinical trial determined by activity-based costing.

PubMed

Chou, Victoria B; Omer, Saad B; Hussain, Hamidah; Mugasha, Christine; Musisi, Maria; Mmiro, Francis; Musoke, Philippa; Jackson, J Brooks; Guay, Laura A

2007-12-01

To determine costs for adverse event (AE) procedures for a large HIV perinatal trial by analyzing actual resource consumption using activity-based costing (ABC) in an international research setting. The AE system for an ongoing clinical trial in Uganda was evaluated using ABC techniques to determine costs from the perspective of the study. Resources were organized into cost categories (eg, personnel, patient care expenses, laboratory testing, equipment). Cost drivers were quantified, and unit cost per AE was calculated. A subset of time and motion studies was performed prospectively to observe clinic personnel time required for AE identification. In 18 months, there were 9028 AEs, with 970 (11%) reported as serious adverse events. Unit cost per AE was $101.97. Overall, AE-related costs represented 32% ($920,581 of $2,834,692) of all study expenses. Personnel ($79.30) and patient care ($11.96) contributed the greatest proportion of component costs. Reported AEs were predominantly nonserious (mild or moderate severity) and unrelated to study drug(s) delivery. Intensive identification and management of AEs to conduct clinical trials ethically and protect human subjects require expenditure of substantial human and financial resources. Better understanding of these resource requirements should improve planning and funding of international HIV-related clinical trials.

Ongoing training of community health workers in low-income andmiddle-income countries: a systematic scoping review of the literature.

PubMed

O'Donovan, James; O'Donovan, Charles; Kuhn, Isla; Sachs, Sonia Ehrlich; Winters, Niall

2018-04-28

Understanding the current landscape of ongoing training for community health workers (CHWs) in low-income and middle-income countries (LMICs) is important both for organisations responsible for their training, as well as researchers and policy makers. This scoping review explores this under-researched area by mapping the current delivery implementation and evaluation of ongoing training provision for CHWs in LMICs. Systematic scoping review. MEDLINE, Embase, AMED, Global Health, Web of Science, Scopus, ASSIA, LILACS, BEI and ERIC. Original studies focusing on the provision of ongoing training for CHWs working in a country defined as low income and middle income according to World Bank Group 2012 classification of economies. The scoping review found 35 original studies that met the inclusion criteria. Ongoing training activities for CHWs were described as supervision (n=19), inservice or refresher training (n=13) or a mixture of both (n=3). Although the majority of studies emphasised the importance of providing ongoing training, several studies reported no impact of ongoing training on performance indicators. The majority of ongoing training was delivered inperson; however, four studies reported the use of mobile technologies to support training delivery. The outcomes from ongoing training activities were measured and reported in different ways, including changes in behaviour, attitudes and practice measured in a quantitative manner (n=16), knowledge and skills (n=6), qualitative assessments (n=5) or a mixed methods approach combining one of the aforementioned modalities (n=8). This scoping review highlights the diverse range of ongoing training for CHWs in LMICs. Given the expansion of CHW programmes globally, more attention should be given to the design, delivery, monitoring and sustainability of ongoing training from a health systems strengthening perspective. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Applying health information technology and team-based care to residency education.

PubMed

Brown, Kristy K; Master-Hunter, Tara A; Cooke, James M; Wimsatt, Leslie A; Green, Lee A

2011-01-01

Training physicians capable of practicing within the Patient-centered Medical Home (PCMH) is an emerging area of scholarly inquiry within residency education. This study describes an effort to integrate PCMH principles into teaching practices within a university-based residency setting and evaluates the effect on clinical performance. Using participant feedback and clinical data extracted from an electronic clinical quality management system, we retrospectively examined performance outcomes at two family medicine residency clinics over a 7-year period. Instructional approaches were identified and clinical performance patterns analyzed. Alumni ratings of the practice-based curriculum increased following institution of the PCMH model. Clinical performance outcomes indicated improvements in the delivery of clinical care to patients. Implementation of instructional methodologies posed some challenges to residency faculty, particularly in development of consistent scheduling of individualized feedback sessions. Residents required the greatest support and guidance in managing point-of-care clinical reminders during patient encounters. Teaching practices that take into consideration the integration of team-based care and use of electronic health technologies can successfully be used to deliver residency education in the context of the PCMH model. Ongoing assessment provides important information to residency directors and faculty in support of improving the quality of clinical instruction.

Embryo quality and implantation rate in two different culture media: ISM1 versus Universal IVF Medium.

PubMed

Xella, Susanna; Marsella, Tiziana; Tagliasacchi, Daniela; Giulini, Simone; La Marca, Antonio; Tirelli, Alessandra; Volpe, Annibale

2010-04-01

To compare the outcome of two different culture media marketed by the MediCult AS Company (Jyllinge, Denmark)-Universal IVF Medium and ISM1 Medium culture-which, in addition to glucose, pyruvate, and energy-providing components, also contain amino acids, nucleotides, vitamins, and cholesterol. Laboratory and retrospective clinical study. University teaching hospital. A total of 726 patients, undergoing IVF-intracytoplasmic sperm injection procedure, comparable in mean age range, oocyte retrieval, and infertility indication, were included in the study. Laboratory quality and standard procedures were maintained unaffected. Oocyte retrieval, different embryo culture media. Embryo quality, ongoing pregnancy, and implantation rate. The frequency of good-quality embryos (79% vs. 74%) and the percentages of ongoing pregnancy (27.5% vs. 18%) and implantation rate (15% vs. 10%) were significantly higher in the group treated with ISM1 Medium rather than Universal IVF Medium. ISM1 Medium culture seems to improve the performance of embryonic growth and development, as well as increasing the percentage of pregnancy. Copyright 2010 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Study protocol of a randomized controlled trial comparing integrative body-mind-spirit intervention and cognitive behavioral therapy in fostering quality of life of patients with lung cancer and their family caregivers.

PubMed

Lau, Bobo Hi-Po; Chow, Amy Y M; Wong, Daniel F K; Chan, Jessie S M; Chan, Celia H Y; Ho, Rainbow T H; So, Tsz-Him; Lam, Tai-Chung; Lee, Victor Ho-Fun; Lee, Anne W M; Chow, Sau Fong; Chan, Cecilia L W

2018-01-01

Compared to cancers at other sites, lung cancer often results in greater psychosocial distress to both the patients and their caregivers, due to the poor prognosis and survival rate, as well as the heavy symptom burden. In recent years, making protocols of proposed or on-going studies publicly available via clinical trial registries and/or peer-reviewed journals has benefited health sciences with timely communication of the latest research trends and improved transparency in reporting. However, such practice is yet to be a common sight in evidence-informed social work. Hence, this paper discusses the value of publishing protocols in social work research and presents the protocol of a randomized controlled trial that compares the effectiveness of integrative body-mind-spirit intervention with cognitive behavioral therapy for enhancing quality of life of patients with lung cancer and their family caregivers. The data collection process was still on-going at the time of manuscript submission.

[Randomized, controlled clinical trials with observational follow-up investigations for evaluating efficacy of antihyperglycaemic treatment. II. Features of and lessons from the follow-up investigations].

PubMed

Jermendy, György

2018-04-01

Although the outcomes of the follow-up investigation period of the randomized clinical studies for evaluating the efficacy of a treatment or an antidiabetic drug may be confounded or potentially biased by several factors, the results are widely accepted by the diabetes community. In line with the theory of metabolic memory or metabolic legacy, early and intensive antihyperglycaemic treatment should be provided for all diabetic patients as this strategy can result in beneficial effects even in the long run. The recent cardiovascular safety trials with new, innovative antidiabetic drugs differ in several aspects from the former efficacy studies. Ten cardiovascular safety trials were completed so far enabling to define their unique and common features. It can be anticipated that the era of randomized, controlled efficacy studies with observational follow-up investigations came to an end in diabetes research. Nowadays, cardiovascular safety trials are in the focus of clinical research in diabetology and results of several ongoing studies are expected with interest in the near future. Orv Hetil. 2018; 159(16): 615-619.

[Collaborative study on regulatory science for facilitating clinical development of gene therapy products for genetic diseases].

PubMed

Uchida, Eriko; Igarashi, Yuka; Sato, Yoji

2014-01-01

Gene therapy products are expected as innovative medicinal products for intractable diseases such as life-threatening genetic diseases and cancer. Recently, clinical developments by pharmaceutical companies are accelerated in Europe and the United States, and the first gene therapy product in advanced countries was approved for marketing authorization by the European Commission in 2012. On the other hand, more than 40 clinical studies for gene therapy have been completed or ongoing in Japan, most of them are conducted as clinical researches by academic institutes, and few clinical trials have been conducted for approval of gene therapy products. In order to promote the development of gene therapy products, revision of the current guideline and/or preparation of concept paper to address the evaluation of the quality and safety of gene therapy products are necessary and desired to clearly show what data should be submitted before First-in-Human clinical trials of novel gene therapy products. We started collaborative study with academia and regulatory agency to promote regulatory science toward clinical development of gene therapy products for genetic diseases based on lentivirus and adeno-associated virus vectors; National Center for Child Health and Development (NCCHD), Nippon Medical School and PMDA have been joined in the task force. At first, we are preparing pre-draft of the revision of the current gene therapy guidelines in this project.

Population and clinical genetics of human transposable elements in the (post) genomic era

PubMed Central

Rishishwar, Lavanya; Wang, Lu; Clayton, Evan A.; Mariño-Ramírez, Leonardo; McDonald, John F.; Jordan, I. King

2017-01-01

ABSTRACT Recent technological developments—in genomics, bioinformatics and high-throughput experimental techniques—are providing opportunities to study ongoing human transposable element (TE) activity at an unprecedented level of detail. It is now possible to characterize genome-wide collections of TE insertion sites for multiple human individuals, within and between populations, and for a variety of tissue types. Comparison of TE insertion site profiles between individuals captures the germline activity of TEs and reveals insertion site variants that segregate as polymorphisms among human populations, whereas comparison among tissue types ascertains somatic TE activity that generates cellular heterogeneity. In this review, we provide an overview of these new technologies and explore their implications for population and clinical genetic studies of human TEs. We cover both recent published results on human TE insertion activity as well as the prospects for future TE studies related to human evolution and health. PMID:28228978

Technology as friend or foe? Do electronic health records increase burnout?

PubMed

Ehrenfeld, Jesse M; Wanderer, Jonathan P

2018-06-01

To summarize recent relevant studies regarding the use of electronic health records and physician burnout. Recently acquired knowledge regarding the relationship between electronic health record use, professional satisfaction, burnout, and desire to leave clinical practice are discussed. Adoption of electronic health records has increased across the United States and worldwide. Although electronic health records have many benefits, there is growing concern about the adverse consequences of their use on physician satisfaction and burnout. Poor usability, incongruent workflows, and the addition of clerical tasks to physician documentation requirements have been previously highlighted as ongoing concerns with electronic health record adoption. In multiple recent studies, electronic health records have been shown to decrease professional satisfaction, increase burnout, and the likelihood that a physician will reduce or leave clinical practice. One interventional study demonstrated a positive effect of a dedicated electronic health record entry clerk on physicians working in an outpatient practice.

Phytochemicals in Cancer Prevention and Therapy: Truth or Dare?

PubMed Central

Russo, Maria; Spagnuolo, Carmela; Tedesco, Idolo; Russo, Gian Luigi

2010-01-01

A voluminous literature suggests that an increase in consumption of fruit and vegetables is a relatively easy and practical strategy to reduce significantly the incidence of cancer. The beneficial effect is mostly associated with the presence of phytochemicals in the diet. This review focuses on a group of them, namely isothiocyanate, curcumin, genistein, epigallocatechin gallate, lycopene and resveratrol, largely studied as chemopreventive agents and with potential clinical applications. Cellular and animal studies suggest that these molecules induce apoptosis and arrest cell growth by pleiotropic mechanisms. The anticancer efficacy of these compounds may result from their use in monotherapy or in association with chemotherapeutic drugs. This latter approach may represent a new pharmacological strategy against several types of cancers. However, despite the promising results from experimental studies, only a limited number of clinical trials are ongoing to assess the therapeutic efficacy of these molecules. Nevertheless, the preliminary results are promising and raise solid foundations for future investigations. PMID:22069598

Sacral neuromodulation in the treatment of the unstable bladder.

PubMed

Bosch, J L

1998-07-01

Sacral neuromodulation as a treatment for urge incontinence in patients with an unstable bladder is the subject of ongoing clinical studies. Although approximately 75% of the patients treated with a permanent sacral foramen electrode implant have experienced significant improvements, it is now also clear that there is an initial failure rate of about 25%. Recent studies have pointed out the importance of improved patient selection on the basis of sex differences, urodynamic parameters and psychological factors. Also, newer forms of test stimulation and permanent electrode implantation are being explored in an effort to improve on the present results.

Does information from ClinicalTrials.gov increase transparency and reduce bias? Results from a five-report case series.

PubMed

Adam, Gaelen P; Springs, Stacey; Trikalinos, Thomas; Williams, John W; Eaton, Jennifer L; Von Isenburg, Megan; Gierisch, Jennifer M; Wilson, Lisa M; Robinson, Karen A; Viswanathan, Meera; Middleton, Jennifer Cook; Forman-Hoffman, Valerie L; Berliner, Elise; Kaplan, Robert M

2018-04-16

We investigated whether information in ClinicalTrials.gov would impact the conclusions of five ongoing systematic reviews. We considered five reviews that included 495 studies total. Each review team conducted a search of ClinicalTrials.gov up to the date of the review's last literature search, screened the records using the review's eligibility criteria, extracted information, and assessed risk of bias and applicability. Each team then evaluated the impact of the evidence found in ClinicalTrials.gov on the conclusions in the review. Across the five reviews, the number of studies that had both a registry record and a publication varied widely, from none in one review to 43% of all studies identified in another. Among the studies with both a record and publication, there was also wide variability in the match between published outcomes and those listed in ClinicalTrials.gov. Of the 173 total ClinicalTrials.gov records identified across the five projects, between 11 and 43% did not have an associated publication. In the 14% of records that contained results, the new data provided in the ClinicalTrials.gov records did not change the results or conclusions of the reviews. Finally, a large number of published studies were not registered in ClinicalTrials.gov, but many of these were published before ClinicalTrials.gov's inception date of 2000. Improved prospective registration of trials and consistent reporting of results in ClinicalTrials.gov would help make ClinicalTrials.gov records more useful in finding unpublished information and identifying potential biases. In addition, consistent indexing in databases, such as MEDLINE, would allow for better matching of records and publications, leading to increased utility of these searches for systematic review projects.

Point-of-care diagnostics for niche applications.

PubMed

Cummins, Brian M; Ligler, Frances S; Walker, Glenn M

2016-01-01

Point-of-care or point-of-use diagnostics are analytical devices that provide clinically relevant information without the need for a core clinical laboratory. In this review we define point-of-care diagnostics as portable versions of assays performed in a traditional clinical chemistry laboratory. This review discusses five areas relevant to human and animal health where increased attention could produce significant impact: veterinary medicine, space travel, sports medicine, emergency medicine, and operating room efficiency. For each of these areas, clinical need, available commercial products, and ongoing research into new devices are highlighted. Copyright © 2016 Elsevier Inc. All rights reserved.

Clinical and translational research in Pneumocystis and Pneumocystis pneumonia*

PubMed Central

Huang, L.

2011-01-01

Pneumocystis pneumonia (PcP) remains a significant cause of morbidity and mortality in immunocompromised persons, especially those with human immunodeficiency virus (HIV) infection. Pneumocystis colonization is described increasingly in a wide range of immunocompromised and immunocompetent populations and associations between Pneumocystis colonization and significant pulmonary diseases such as chronic obstructive pulmonary disease (COPD) have emerged. This mini-review summarizes recent advances in our clinical understanding of Pneumocystis and PcP, describes ongoing areas of clinical and translational research, and offers recommendations for future clinical research from researchers participating in the “First centenary of the Pneumocystis discovery”. PMID:21395200

Associations between Neighborhood Walkability and Incident and Ongoing Asthma in Children.

PubMed

Simons, Elinor; Dell, Sharon D; Moineddin, Rahim; To, Teresa

2018-06-01

Childhood asthma has shown variable associations with children's physical activity. Neighborhood walkability captures community features that promote walking and is protective against some chronic conditions, such as obesity and diabetes. We evaluated associations between home neighborhood walkability and incident and ongoing childhood asthma. In this population-based cohort study, we used prospectively collected administrative healthcare data for the Province of Ontario housed at the Institute for Clinical Evaluative Sciences. We followed an administrative data cohort of 326,383 Toronto children born between 1997 and 2003, inclusive, until ages 8-15 years. Home neighborhood walkability quintile was measured using a validated walkability index with four dimensions: population density, dwelling density, access to retail and services, and street connectivity. Incident asthma was defined by time of entry into the validated Ontario Asthma Surveillance Information System database, which requires two outpatient visits for asthma within two consecutive years or any hospitalization for asthma and follows children with asthma longitudinally starting at any age. Associations between walkability and incident asthma were examined using Cox proportional hazards models. Associations between ongoing asthma and walkability in each year of life were examined using generalized linear mixed models. Twenty-one percent of children (n = 69,628) developed incident asthma and were followed longitudinally in the Ontario Asthma Surveillance Information System database. Low birth home neighborhood walkability was associated with an increased incidence of asthma (hazard ratio, 1.11; 95% confidence interval, 1.08-1.14). Among children with asthma, low walkability in a given year of a child`s life was associated with greater odds of ongoing asthma in the same year (odds ratio, 1.12; 95% confidence interval, 1.09-1.14). Children living in neighborhoods with low walkability were at increased risk of incident and ongoing asthma. Neighborhood walkability improvement, such as by adding pedestrian paths to improve street connectivity, offers potential strategies to contribute to primary asthma prevention.

Impact of sarcopenia in the management of urological cancer patients.

PubMed

Fukushima, Hiroshi; Koga, Fumitaka

2017-05-01

Sarcopenia, the degenerative and systemic loss of skeletal muscle mass, develops as a consequence of the progression of cancer cachexia. Recent studies suggest that sarcopenia may be used as a biomarker in the management of patients with several cancers. Areas covered: In this article, the authors review 1) the methods to simply and optimally evaluate and define sarcopenia using computed tomography images in daily clinical practice and 2) the impact of sarcopenia in the management of urological cancers, specifically focusing on the usefulness in predicting treatment-related complications and prognosis. The authors also discuss the prognostic importance of changes in skeletal muscle mass in the course of treatment and the potential roles of nutritional support and exercise to prevent progression of sarcopenia. Expert commentary: Sarcopenia is associated with treatment-related complications and unfavorable prognosis in urological cancer patients. Nutritional support and exercise might be helpful in improving sarcopenia. The impact of these interventions on clinical outcomes would be elucidated by ongoing or future clinical studies.

Readiness for diabetes prevention and barriers to lifestyle change in women with a history of gestational diabetes mellitus: rationale and study design.

PubMed

Lipscombe, Lorraine L; Banerjee, Ananya Tina; McTavish, Sarah; Mukerji, Geetha; Lowe, Julia; Ray, Joel; Evans, Marilyn; Feig, Denice S

2014-10-01

Women with gestational diabetes mellitus (GDM) have a high risk of future diabetes, which can be prevented with lifestyle modification. Prior diabetes prevention programmes in this population have been limited by lack of adherence. The aim of this study is to evaluate readiness for behaviour change at different time points after GDM diagnosis and identify barriers and facilitators, to inform a lifestyle modification programme specifically designed for this group. The objective of this paper is to present the rationale and methodological design of this study. The ongoing prospective cohort study has recruited a multi-ethnic cohort of 1353 women with GDM from 7 Ontario, Canada hospitals during their pregnancy. A questionnaire was developed to evaluate stage of readiness for behaviour change, and sociodemographic, psychosocial, and clinical predictors of healthy diet and physical activity. Thus far, 960 women (71%) have completed a baseline survey prior to delivery. Prospective postpartum follow-up is ongoing. We are surveying women at 2 time-points after delivery: 3-12 months postpartum, and 13-24 months postpartum. Survey data will be linked to health care administrative databases for long-term follow-up for diabetes. Qualitative interviews were conducted in a subset of women to gain a deeper understanding of barriers and facilitators to lifestyle change. Our study is a fundamental first step in effectively addressing diabetes prevention in women with GDM. Our findings will aid in the design of a diabetes prevention intervention specifically targeted to women with recent GDM, which can then be evaluated in a clinical trial. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

TRIGLYCERIDES, ATHEROSCLEROSIS, AND CARDIOVASCULAR OUTCOME STUDIES: FOCUS ON OMEGA-3 FATTY ACIDS.

PubMed

Handelsman, Yehuda; Shapiro, Michael D

2017-01-01

To provide an overview of the roles of triglycerides and triglyceride-lowering agents in atherosclerosis in the context of cardiovascular outcomes studies. We reviewed the published literature as well as ClinicalTrials.gov entries for ongoing studies. Despite improved atherosclerotic cardiovascular disease (ASCVD) outcomes with statin therapy, residual risk remains. Epidemiologic data and recent genetic insights provide compelling evidence that triglycerides are in the causal pathway for the development of atherosclerosis, thereby renewing interest in targeting triglycerides to improve ASCVD outcomes. Fibrates, niacin, and omega-3 fatty acids (OM3FAs) are three classes of triglyceride-lowering drugs. Outcome studies with triglyceride-lowering agents have been inconsistent. With regard to OM3FAs, the JELIS study showed that eicosapentaenoic acid (EPA) significantly reduced major coronary events in statin-treated hypercholesterolemic patients. Regarding other agents, extended-release niacin and fenofibrate are no longer recommended as statin add-on therapy (by some guidelines, though not all) because of the lack of convincing evidence from outcome studies. Notably, subgroup analyses from the outcome studies have generated the hypothesis that triglyceride lowering may provide benefit in statin-treated patients with persistent hypertriglyceridemia. Two ongoing OM3FA outcome studies (REDUCE-IT and STRENGTH) are testing this hypothesis in high-risk, statin-treated patients with triglyceride levels of 200 to 500 mg/dL. There is consistent evidence that triglycerides are in the causal pathway of atherosclerosis but inconsistent evidence from cardiovascular outcomes studies as to whether triglyceride-lowering agents reduce cardiovascular risk. Ongoing outcomes studies will determine the role of triglyceride lowering in statin-treated patients with high-dose prescription OM3FAs in terms of improved ASCVD outcomes. AACE = American Association of Clinical Endocrinologists ACCORD = Action to Control Cardiovascular Risk in Diabetes AIM-HIGH = Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health Outcomes apo = apolipoprotein ASCEND = A Study of Cardiovascular Events in Diabetes ASCVD = atherosclerotic cardiovascular disease BIP = Bezafibrate Infarction Prevention CHD = coronary heart disease CI = confidence interval CV = cardiovascular CVD = cardiovascular disease DHA = docosahexaenoic acid DO-IT = Diet and Omega-3 Intervention Trial EPA = eicosapentaenoic acid FIELD = Fenofibrate Intervention and Event Lowering in Diabetes GISSI-HF = GISSI-Heart Failure HDL-C = high-density-lipoprotein cholesterol HPS2-THRIVE = Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events HR = hazard ratio JELIS = Japan Eicosapentaenoic Acid Lipid Intervention Study LDL = low-density lipoprotein LDL-C = low-density-lipoprotein cholesterol MI = myocardial infarction OM3FAs = omega-3 fatty acids VITAL = Vitamin D and Omega-3 Trial.

High expression of AID and active class switch recombination might account for a more aggressive disease in unmutated CLL patients: link with an activated microenvironment in CLL disease.

PubMed

Palacios, Florencia; Moreno, Pilar; Morande, Pablo; Abreu, Cecilia; Correa, Agustín; Porro, Valentina; Landoni, Ana Ines; Gabus, Raul; Giordano, Mirta; Dighiero, Guillermo; Pritsch, Otto; Oppezzo, Pablo

2010-06-03

Interaction of chronic lymphocytic leukemia (CLL) B cells with tissue microenvironment has been suggested to favor disease progression by promoting malignant B-cell growth. Previous work has shown expression in peripheral blood (PB) of CLL B cells of activation-induced cytidine deaminase (AID) among CLL patients with an unmutated (UM) profile of immunoglobulin genes and with ongoing class switch recombination (CSR) process. Because AID expression results from interaction with activated tissue microenvironment, we speculated whether the small subset with ongoing CSR is responsible for high levels of AID expression and could be derived from this particular microenvironment. In this work, we quantified AID expression and ongoing CSR in PB of 50 CLL patients and characterized the expression of different molecules related to microenvironment interaction. Our results show that among UM patients (1) high AID expression is restricted to the subpopulation of tumoral cells ongoing CSR; (2) this small subset expresses high levels of proliferation, antiapoptotic and progression markers (Ki-67, c-myc, Bcl-2, CD49d, and CCL3/4 chemokines). Overall, this work outlines the importance of a cellular subset in PB of UM CLL patients with a poor clinical outcome, high AID levels, and ongoing CSR, whose presence might be a hallmark of a recent contact with the microenvironment.

Defining the value of a comparative approach to cancer drug development

PubMed Central

LeBlanc, AK; Mazcko, C; Khanna, C

2016-01-01

Comparative oncology as a tool in drug development requires a deeper examination of the value of the approach and examples of where this approach can satisfy unmet needs. This review seeks to demonstrate types of drug development questions that are best answered by the comparative oncology approach. We believe common perceived risks of the comparative approach relate to uncertainty of how regulatory bodies will prioritize or react to data generated from these unique studies conducted in diseased animals, and how these new data will affect ongoing human clinical trials. We contend that it is reasonable to consider these data as potentially informative and valuable to cancer drug development, but as supplementary to conventional preclinical studies and human clinical trials particularly as they relate to the identification of drug-associated adverse events. PMID:26712689

Patient Recruitment 2.0: Become a Partner in the Patient Journey Using Digital Media

PubMed Central

Lindemann, Michael; Freeman, Tobe; Kilchenmann, Timothy; Harrison, Shuree; Chan, Margaret; Wygonik, Mark; Haines, Lea

2016-01-01

We describe a digital platform, Pioneering Healthcare, designed to inform and empower people who are impacted by lung cancer. The platform enables Roche to support an online conversation with patients and caregivers about lung cancer, and about the role of lung cancer clinical studies in the development of future treatment options. This conversation is live and ongoing on the platform. It provides insights about the views and motivations of patients, and about how to better support patients pursuing treatment for life-threatening illness. We discuss the strategies used to deploy Pioneering Healthcare, and the advantages of using digital platforms for raising disease awareness, increasing patient engagement and, ultimately, for boosting patient enrollment into clinical trials. PMID:26818938

Circulating cell-derived microparticles as biomarkers in cardiovascular disease.

PubMed

Thulin, Åsa; Christersson, Christina; Alfredsson, Jenny; Siegbahn, Agneta

2016-09-01

Cardiovascular diseases (CVDs) are a common cause of death, and a search for biomarkers for risk stratification is warranted. Elevated levels of cell-derived microparticles (MPs) are found in patients with CVD and in groups with risk factors for CVD. Subpopulations of MPs are promising biomarkers for improving risk prediction, as well as monitoring treatment. However, the field has been hampered by technical difficulties, and the ongoing development of sensitive standardized techniques is crucial for implementing MP analyses in the clinic. Large prospective studies are required to establish which MPs are of prognostic value in different patient groups. In this review, we discuss methodological challenges and progress in the field, as well as MP populations that are of interest for further clinical evaluation.

7T: Physics, safety, and potential clinical applications.

PubMed

Kraff, Oliver; Quick, Harald H

2017-12-01

With more than 60 installed magnetic resonance imaging (MRI) systems worldwide operating at a magnetic field strength of 7T or higher, ultrahigh-field (UHF) MRI has been established as a platform for clinically oriented research in recent years. Profound technical and methodological developments have helped overcome the inherent physical challenges of UHF radiofrequency (RF) signal homogenization in the human body. The ongoing development of dedicated RF coil arrays was pivotal in realizing UHF body MRI, beyond mere brain imaging applications. Another precondition to clinical application of 7T MRI is the safety testing of implants and the establishment of safety concepts. Against this backdrop, 7T MRI and MR spectroscopy (MRS) recently have demonstrated capabilities and potentials for clinical diagnostics in a variety of studies. This article provides an overview of the immanent physical challenges of 7T UHF MRI and discusses recent technical solutions and safety concepts. Furthermore, recent clinically oriented studies are highlighted that span a broad application spectrum from 7T UHF brain to body MRI. 4 Technical Efficacy: Stage 1 J. Magn. Reson. Imaging 2017;46:1573-1589. © 2017 International Society for Magnetic Resonance in Medicine.

Reagent-free bacterial identification using multivariate analysis of transmission spectra

NASA Astrophysics Data System (ADS)

Smith, Jennifer M.; Huffman, Debra E.; Acosta, Dayanis; Serebrennikova, Yulia; García-Rubio, Luis; Leparc, German F.

2012-10-01

The identification of bacterial pathogens from culture is critical to the proper administration of antibiotics and patient treatment. Many of the tests currently used in the clinical microbiology laboratory for bacterial identification today can be highly sensitive and specific; however, they have the additional burdens of complexity, cost, and the need for specialized reagents. We present an innovative, reagent-free method for the identification of pathogens from culture. A clinical study has been initiated to evaluate the sensitivity and specificity of this approach. Multiwavelength transmission spectra were generated from a set of clinical isolates including Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus aureus. Spectra of an initial training set of these target organisms were used to create identification models representing the spectral variability of each species using multivariate statistical techniques. Next, the spectra of the blinded isolates of targeted species were identified using the model achieving >94% sensitivity and >98% specificity, with 100% accuracy for P. aeruginosa and S. aureus. The results from this on-going clinical study indicate this approach is a powerful and exciting technique for identification of pathogens. The menu of models is being expanded to include other bacterial genera and species of clinical significance.

Retooling Institutional Support Infrastructure for Clinical Research

PubMed Central

Snyder, Denise C.; Brouwer, Rebecca N.; Ennis, Cory L.; Spangler, Lindsey L.; Ainsworth, Terry L.; Budinger, Susan; Mullen, Catherine; Hawley, Jeffrey; Uhlenbrauck, Gina; Stacy, Mark

2016-01-01

Clinical research activities at academic medical centers are challenging to oversee. Without effective research administration, a continually evolving set of regulatory and institutional requirements can detract investigator and study team attention away from a focus on scientific gain, study conduct, and patient safety. However, even when the need for research administration is recognized, there can be struggles over what form it should take. Central research administration may be viewed negatively, with individual groups preferring to maintain autonomy over processes. Conversely, a proliferation of individualized approaches across an institution can create inefficiencies or invite risk. This article describes experiences establishing a unified research support office at the Duke University School of Medicine based on a framework of customer support. The Duke Office of Clinical Research was formed in 2012 with a vision that research administration at academic medical centers should help clinical investigators navigate the complex research environment and operationalize research ideas. The office provides an array of services that have received high satisfaction ratings. The authors describe the ongoing culture change necessary for success of the unified research support office. Lessons learned from implementation of the Duke Office of Clinical Research may serve as a model for other institutions undergoing a transition to unified research support. PMID:27125563

Neuroprotection and neurotoxicity in the developing brain: an update on the effects of dexmedetomidine and xenon.

PubMed

Alam, Azeem; Suen, Ka Chun; Hana, Zac; Sanders, Robert D; Maze, Mervyn; Ma, Daqing

Growing and consistent preclinical evidence, combined with early clinical epidemiological observations, suggest potentially neurotoxic effects of commonly used anesthetic agents in the developing brain. This has prompted the FDA to issue a safety warning for all sedatives and anesthetics approved for use in children under three years of age. Recent studies have identified dexmedetomidine, the potent α2-adrenoceptor agonist, and xenon, the noble gas, as effective anesthetic adjuvants that are both less neurotoxic to the developing brain, and also possess neuroprotective properties in neonatal and other settings of acute ongoing neurologic injury. Dexmedetomidine and xenon are effective anesthetic adjuvants that appear to be less neurotoxic than other existing agents and have the potential to be neuroprotective in the neonatal and pediatric settings. Although results from recent clinical trials and case reports have indicated the neuroprotective potential of xenon and dexmedetomidine, additional randomized clinical trials corroborating these studies are necessary. By reviewing both the existing preclinical and clinical evidence on the neuroprotective effects of dexmedetomidine and xenon, we hope to provide insight into the potential clinical efficacy of these agents in the management of pediatric surgical patients. Copyright © 2017 Elsevier Inc. All rights reserved.

Clinical handover of patients arriving by ambulance to the emergency department - a literature review.

PubMed

Bost, Nerolie; Crilly, Julia; Wallis, Marianne; Patterson, Elizabeth; Chaboyer, Wendy

2010-10-01

To provide a critical review of research on clinical handover between the ambulance service and emergency department (ED) in hospitals. Data base and hand searches were conducted using the keywords ambulance, handover, handoff, emergency department, emergency room, ER, communication, and clinical handover. Data were extracted, summarised and critically assessed to provide evidence of current clinical handover processes. From 252 documents, eight studies fitted the inclusion criteria of clinical handover and the ambulance to ED patient transfer. Three themes were identified in the review: (1) important information may be missed during clinical handover; (2) structured handovers that include both written and verbal components may improve information exchange; (3) multidisciplinary education about the clinical handover process may encourage teamwork, a shared common language and a framework for minimum patient information to be transferred from the ambulance service to the hospital ED. Knowledge gaps exist concerning handover information, consequences of poor handover, transfer of responsibility, staff perception of handovers, staff training and evaluation of recommended strategies to improve clinical handover. Evidence of strategies being implemented and further research is required to examine the ongoing effects of implementing the strategies. Copyright © 2009 Elsevier Ltd. All rights reserved.

Baroreflex Activation Therapy in Congestive Heart Failure: Novel Findings and Future Insights.

PubMed

Grassi, Guido; Brambilla, GianMaria; Pizzalla, Daniela Prata; Seravalle, Gino

2016-08-01

Congestive heart failure is characterized by hemodynamic and non-hemodynamic abnormalities, the latter including an activation of the sympathetic influences to the heart and peripheral circulation coupled with an impairment of baroreceptor control of autonomic function. Evidence has been provided that both these alterations are hallmark features of the disease with a specific relevance for the disease progression as well as for the development of life-threatening cardiac arrhythmias. In addition, a number of studies have documented in heart failure the adverse prognostic role of the sympathetic and baroreflex alterations, which both are regarded as major independent determinants of cardiovascular morbidity and mortality. This represents the pathophysiological and clinical background for the use of carotid baroreceptor activation therapy in the treatment of congestive heart failure. Promising data collected in experimental animal models of heart failure have supported the recent performance of pilot small-scale clinical studies, aimed at providing initial information in this area. The results of these studies demonstrated the clinical safety and efficacy of the intervention which has been tested in large-scale clinical studies. The present paper will critically review the background and main results of the published studies designed at defining the clinical impact of baroreflex activation therapy in congestive heart failure patients. Emphasis will be given to the strengths and limitations of such studies, which represent the background for the ongoing clinical trials testing the long-term effects of the device in heart failure patients.

Silybin and the liver: From basic research to clinical practice

PubMed Central

Loguercio, Carmela; Festi, Davide

2011-01-01

Herbal products are increasingly used, mainly in chronic liver disease. Extracts of milk thistle, Silymarin and silybin, are the most prescribed natural compounds, with different indications, but with no definitive results in terms of clinical efficacy. This review analyzes the available studies on the effects of the purified product silybin, both as a free and a conjugated molecule, on liver cells or on experimentally induced liver damage, and in patients with liver disease. We searched PUBMED for articles pertaining to the in vitro and in vivo effects of silybin, its antifibrotic, anti-inflammatory, and antioxidant properties, as well as its metabolic effects, combined with the authors’ own knowledge of the literature. Results indicate that the bioavailability of silybin phytosome is higher than that of silymarin and is less influenced by liver damage; silybin does not show significant interactions with other drugs and at doses < 10 g/d has no significant side effects. Experimental studies have clearly demonstrated the antifibrotic, antioxidant and metabolic effects of silybin; previous human studies were insufficient for confirming the clinical efficacy in chronic liver disease, while ongoing clinical trials are promising. On the basis of literature data, silybin seems a promising drug for chronic liver disease. PMID:21633595

Preclinical Antileukemia Activity of Tramesan: A Newly Identified Bioactive Fungal Metabolite.

PubMed

Ricciardi, M R; Licchetta, R; Mirabilii, S; Scarpari, M; Parroni, A; Fabbri, A A; Cescutti, P; Reverberi, M; Fanelli, C; Tafuri, A

2017-01-01

Despite improvements that occurred in the last decades in the acute myeloid leukemia (AML) treatment, clinical results are still unsatisfactory. More effective therapies are required, and innovative approaches are ongoing, including the discovery of novel antileukemia natural compounds. Several studies have described the activity of extracts from mushrooms which produce compounds that exhibited immunological and antitumor activities. The latter has been demonstrated to be promoted in vitro by mushroom polysaccharides via induction of apoptosis. However, the antileukemia activity of these compounds on primary cells is still not reported. In the present study, we examined the in vitro effects of Tramesan (TR), a bioactive compound extracted from Trametes versicolor , on leukemic cell lines and primary cells. Our results demonstrated that TR induced a marked growth inhibition of leukemic cell lines and primary cells from AML patients. The antiproliferative effects of TR were associated in primary AML cells with a significant increase of apoptosis. No significant cytotoxic effects were observed in normal peripheral blood mononuclear cells (MNC) from healthy donors. Our data demonstrated a cytotoxic activity of TR on leukemia cells prompting further translational applications. Ongoing studies are elucidating the molecular mechanisms underlying its antileukemic activity.

Preclinical Antileukemia Activity of Tramesan: A Newly Identified Bioactive Fungal Metabolite

PubMed Central

Scarpari, M.; Parroni, A.; Fabbri, A. A.; Cescutti, P.; Reverberi, M.; Fanelli, C.

2017-01-01

Despite improvements that occurred in the last decades in the acute myeloid leukemia (AML) treatment, clinical results are still unsatisfactory. More effective therapies are required, and innovative approaches are ongoing, including the discovery of novel antileukemia natural compounds. Several studies have described the activity of extracts from mushrooms which produce compounds that exhibited immunological and antitumor activities. The latter has been demonstrated to be promoted in vitro by mushroom polysaccharides via induction of apoptosis. However, the antileukemia activity of these compounds on primary cells is still not reported. In the present study, we examined the in vitro effects of Tramesan (TR), a bioactive compound extracted from Trametes versicolor, on leukemic cell lines and primary cells. Our results demonstrated that TR induced a marked growth inhibition of leukemic cell lines and primary cells from AML patients. The antiproliferative effects of TR were associated in primary AML cells with a significant increase of apoptosis. No significant cytotoxic effects were observed in normal peripheral blood mononuclear cells (MNC) from healthy donors. Our data demonstrated a cytotoxic activity of TR on leukemia cells prompting further translational applications. Ongoing studies are elucidating the molecular mechanisms underlying its antileukemic activity. PMID:29270245

Stereotactic radiotherapy for early lung cancer: Evidence-based approach and future directions

PubMed Central

Chehade, Samer; Palma, David A.

2015-01-01

Aim To review key studies evaluating stereotactic radiotherapy in the setting of early-stage non-small cell lung cancer (NSCLC) for inoperable or high-risk patients, and discuss areas of ongoing research and clinical trials. Background The use of stereotactic radiotherapy for the treatment of early stage non-small cell lung cancer (NSCLC) has increased rapidly over the past decade. Numerous studies have reported outcomes for patients treated with SBRT who are unfit for surgical resection, or at high risk of surgical complications. Materials and methods A narrative review. Results The preponderance of evidence suggests that SBRT is associated with excellent local control (∼90% at 3 years) and a favorable toxicity profile. In patients with higher operative risks, such as the elderly and patients with severe COPD, SBRT may provide a less-toxic treatment than surgery with similar oncologic outcomes. Ongoing studies are evaluating the use of SBRT for locally advanced or oligometastatic NSCLC. Conclusions A large body of evidence now exists to support the use of SBRT for early-stage NSCLC. Decisions regarding the optimal choice of treatment should be individualized, and made in the context of a multidisciplinary team. PMID:26696779

VIRTUAL REALITY HYPNOSIS FOR PAIN CONTROL IN A PATIENT WITH GLUTEAL HIDRADENITIS:A CASE REPORT1

PubMed Central

SOLTANI, MARYAM; TEELEY, AUBRIANA M.; WIECHMAN, SHELLEY A.; JENSEN, MARK P.; SHARAR, SAM R.; PATTERSON, DAVID R.

2012-01-01

This case report describes the use of hypnotic analgesia induced through immersive three-dimensional computer-generated virtual reality, better known as virtual reality hypnosis (VRH), in the treatment of a patient with ongoing pain associated with gluteal hidradenitis, The patient participated in the study for two consecutive days white hospitalized at a regional trauma centre. At pretreatment, she reported severe pain intensity and unpleasantness as well as high levels of anxiety and nervousness. She was then administered two sessions of virtual reality hypnotic treatment for decreased pain and anxiety. The patient’s ratings of ‘time spent thinking about pain’, pain intensity, ‘unpleasantness of pain’, and anxiety decreased from before to after each daily VRH session, as well as from Day One to Day Two. The findings indicate that VRH may benefit individuals with severe, ongoing pain from a chronic condition, and that a controlled clinical trial examining its efficacy is warranted. PMID:23205274

Conserved hypothetical protein Rv1977 in Mycobacterium tuberculosis strains contains sequence polymorphisms and might be involved in ongoing immune evasion.

PubMed

Jiang, Yi; Liu, Haican; Wang, Xuezhi; Li, Guilian; Qiu, Yan; Dou, Xiangfeng; Wan, Kanglin

2015-01-01

Host immune pressure and associated parasite immune evasion are key features of host-pathogen co-evolution. A previous study showed that human T cell epitopes of Mycobacterium tuberculosis are evolutionarily hyperconserved and thus it was deduced that M. tuberculosis lacks antigenic variation and immune evasion. Here, we selected 151 clinical Mycobacterium tuberculosis isolates from China, amplified gene encoding Rv1977 and compared the sequences. The results showed that Rv1977, a conserved hypothetical protein, is not conserved in M. tuberculosis strains and there are polymorphisms existed in the protein. Some mutations, especially one frameshift mutation, occurred in the antigen Rv1977, which is uncommon in M.tb strains and may lead to the protein function altering. Mutations and deletion in the gene all affect one of three T cell epitopes and the changed T cell epitope contained more than one variable position, which may suggest ongoing immune evasion.

Using the Frailty Assessment for Care Planning Tool (FACT) to screen elderly chronic kidney disease patients for frailty: the nurse experience.

PubMed

Moffatt, Heather; Moorhouse, Paige; Mallery, Laurie; Landry, David; Tennankore, Karthik

2018-01-01

Recent evidence supports the prognostic significance of frailty for functional decline and poor health outcomes in patients with chronic kidney disease. Yet, despite the development of clinical tools to screen for frailty, little is known about the experiential impact of screening for frailty in this setting. The Frailty Assessment for Care Planning Tool (FACT) evaluates frailty across 4 domains: mobility, function, social circumstances, and cognition. The purpose of this qualitative study was as follows: 1) explore the nurse experience of screening for frailty using the FACT tool in a specialized outpatient renal clinic; 2) determine how, if at all, provider perceptions of frailty changed after implementation of the frailty screening tool; and 3) determine the perceived factors that influence uptake and administration of the FACT screening tool in a specialized clinical setting. A semi-structured interview of 5 nurses from the Nova Scotia Health Authority, Central Zone Renal Clinic was conducted. A grounded theory approach was used to generate thematic categories and analysis models. Four primary themes emerged in the data analysis: "we were skeptical", "we made it work", "we learned how", and "we understand". As the renal nurses gained a sense of confidence in their ability to implement the FACT tool, initial barriers to implementation were attenuated. Implementation factors - such as realistic goals, clear guidelines, and ongoing training - were important factors for successful uptake of the frailty screening initiative. Nurse participants reported an overall positive experience using the FACT method to screen for frailty and indicated that their understanding of the multiple dimensions and subtleties of "frailty" were enhanced. Future nurse-led FACT screening initiatives should incorporate those factors identified as being integral to program success: realistic goals, clear guidelines, and ongoing training. Adopting the evaluation of frailty as a priority within clinical departments will encourage sustainability.

Relationship between arsenic skin lesions and the age of natural menopause

PubMed Central

2014-01-01

Background Chronic exposure to arsenic is associated with neoplastic, cardiovascular, endocrine, neuro-developmental disorders and can have an adverse effect on women’s reproductive health outcomes. This study examined the relationship between arsenic skin lesions (a hallmark sign of chronic arsenic poisoning) and age of natural menopause (final menopausal period) in populations with high levels of arsenic exposure in Bangladesh. Methods We compared menopausal age in two groups of women – with and without arsenic skin lesions; and presence of arsenic skin lesions was used as an indicator for chronic arsenic exposure. In a cross-sectional study, a total of 210 participants were randomly identified from two ongoing studies— participants with arsenic skin lesions were identified from an ongoing clinical trial and participants with no arsenic skin lesions were identified from an ongoing cohort study. Mean age of menopause between these two groups were calculated and compared. Multivariable linear regression was used to estimate the relationship between the status of the arsenic skin lesions and age of natural menopause in women. Results Women with arsenic skin lesions were 1.5 years younger (p <0.001) at the time of menopause compared to those without arsenic skin lesions. After adjusting with contraceptive use, body mass index, urinary arsenic level and family history of premature menopause, the difference between the groups’ age at menopause was 2.1 years earlier (p <0.001) for respondents with arsenic skin lesions. Conclusions The study showed a statistically significant association between chronic exposure to arsenic and age at menopause. Heavily exposed women experienced menopause two years earlier than those with lower or no exposure. PMID:24886424

Long-term management of IPF with pirfenidone - a clinical case study with 5 years follow-up.

PubMed

Richeldi, L; Sgalla, G; Cerri, S

2013-09-01

Idiopathic pulmonary fibrosis (IPF) is a progressively fibrotic interstitial lung disease that is associated with a median survival of 2-5 years from initial diagnosis. To date, the search for an effective treatment has involved numerous clinical trials of investigational agents but without significant success. Nevertheless, research over the past 10 years has provided us with a wealth of information on its histopathology, diagnostic work-up, and a greater understanding of its pathophysiology. Specifically, IPF is no longer thought to be a predominantly pro-inflammatory disorder. Rather, the fibrosis in IPF is increasingly understood to be the result of a fibroproliferative and aberrant wound healing cascade. The development of therapeutic targets has therefore shifted in accordance with this paradigm change. Emerging clinical data from recently published and ongoing trials investigating new potential pharmacological agents should be considered in the routine clinical management of these patients. Based upon encouraging results from randomised-controlled trials showing a positive effect in slowing decline in pulmonary function and reducing disease progression, pirfenidone was approved in 2011 as the first treatment in patients with IPF. This case study describes the clinical course of a patient enrolled into the Phase III and open-label extension studies of pirfenidone.

Review of clinical trials evaluating safety and efficacy of milk thistle (Silybum marianum [L.] Gaertn.).

PubMed

Tamayo, Carmen; Diamond, Suzanne

2007-06-01

Milk thistle extracts have been used as traditional herbal remedies for almost 2000 years. The extracts are still widely used to protect the liver against toxins and to control chronic liver diseases. Recent experimental and clinical studies suggest that milk thistle extracts also have anticancer, antidiabetic, and cardioprotective effects. This article reviews clinical trials of milk thistle conducted in the past 5 years including pharmacokinetic and toxicity studies, herb-drug interactions, and other safety issues. Several trials have studied the effects of milk thistle for patients with liver diseases, cancer, hepatitis C, HIV, diabetes, and hypercholesterolemia. Promising results have been reported in the protective effect of milk thistle in certain types of cancer, and ongoing trials will provide more evidence about this effect. In addition, new established doses and improvement on the quality and standardization of this herb will provide the much-awaited evidence about the efficacy of milk thistle in the treatment of liver diseases. Milk thistle extracts are known to be safe and well tolerated, and toxic or adverse effects observed in the reviewed clinical trials seem to be minimal. The future of milk thistle research is promising, and high-quality randomized clinical trials on milk thistle versus placebo may be needed to further demonstrate the safety and efficacy of this herb.

A qualitative study of patient experiences of Type 2 Diabetes care delivered comparatively by General Practice Nurses and Medical Practitioners.

PubMed

Boyle, Eileen; Saunders, Rosemary; Drury, Vicki

2016-07-01

To explore patient experiences of type 2 diabetes mellitus care delivered by general practice nurses in collaboration with the general practitioner. Australian general practice nurses are expanding their role in multidisciplinary type 2 diabetes care with limited research on patient perceptions of care provision within this collaborative model. Qualitative interpretive. Purposeful sampling was used to invite the patients (n = 10). Data were collected from semi-structured face-to-face interviews. Braun and Clarke's () inductive coding thematic analysis process was used to interpret the data. All participants experienced their General Practice Nurse consultation as a clinical assessment for their General Practitioner. While they appreciated the extra time with the General Practice Nurse, they were unsure of the purpose of the consultation beyond clinical assessment. They described the ongoing challenge of living with T2DM and identified a need for additional information and advice. The results suggest that the model of general practice nurse type 2 diabetes care has an important role to play in the delivery of effective ongoing care of patients. However, this role requires further development to ensure that it is understood by the patients as a role that not only conducts clinical assessments but also provides relevant education and self-management support as part of a collaborative approach to care delivery with General Practitioners. The findings are relevant to primary health care clinicians providing diabetes care to inform more relevant supportive care by general practice nurses. © 2016 John Wiley & Sons Ltd.

Integration of Palliative Care Principles into the Ongoing Care of Children with Cancer: Individualized Care Planning and Coordination

PubMed Central

Baker, Justin N; Hinds, Pamela S; Spunt, Sheri L; Barfield, Raymond C; Allen, Caitlin; Powell, Brent C; Anderson, Lisa H; Kane, Javier R

2008-01-01

Synopsis The Individualized Care Planning and Coordination Model is designed to integrate palliative care principles and practices into the ongoing care of children with cancer. Application of the model helps clinicians to generate a comprehensive individualized care plan that is implemented through Individualized Care Coordination processes as detailed here. Clinicians’ strong desire to provide compassionate, competent and sensitive care to the seriously ill child and the child’s family can be effectively translated into clinical practice through these processes. “To cure sometimes, to relieve often, to comfort always -- this is our work.” Author Unknown PMID:18242323

Direct conversion semiconductor detectors in positron emission tomography

NASA Astrophysics Data System (ADS)

Cates, Joshua W.; Gu, Yi; Levin, Craig S.

2015-05-01

Semiconductor detectors are playing an increasing role in ongoing research to improve image resolution, contrast, and quantitative accuracy in preclinical applications of positron emission tomography (PET). These detectors serve as a medium for direct detection of annihilation photons. Early clinical translation of this technology has shown improvements in image quality and tumor delineation for head and neck cancers, relative to conventional scintillator-based systems. After a brief outline of the basics of PET imaging and the physical detection mechanisms for semiconductor detectors, an overview of ongoing detector development work is presented. The capabilities of semiconductor-based PET systems and the current state of these devices are discussed.

Reflective Supervision: A Clinical Supervision Model for Fostering Professional Growth

ERIC Educational Resources Information Center

Costello, Lisa H.; Belcaid, Erin; Arthur-Stanley, Amanda

2018-01-01

School psychologists experience a broad range of stressors in their role as school support professionals including feelings of isolation, insufficient resources, administrative pressures, and excessive caseloads (Boccio, Wiesz, & Lefkowitz, 2016). Ongoing support is necessary to help school psychologists successfully navigate these…

Current concepts of severe asthma

PubMed Central

Raundhal, Mahesh; Oriss, Timothy B.; Ray, Prabir; Wenzel, Sally E.

2016-01-01

The term asthma encompasses a disease spectrum with mild to very severe disease phenotypes whose traditional common characteristic is reversible airflow limitation. Unlike milder disease, severe asthma is poorly controlled by the current standard of care. Ongoing studies using advanced molecular and immunological tools along with improved clinical classification show that severe asthma does not identify a specific patient phenotype, but rather includes patients with constant medical needs, whose pathobiologic and clinical characteristics vary widely. Accordingly, in recent clinical trials, therapies guided by specific patient characteristics have had better outcomes than previous therapies directed to any subject with a diagnosis of severe asthma. However, there are still significant gaps in our understanding of the full scope of this disease that hinder the development of effective treatments for all severe asthmatics. In this Review, we discuss our current state of knowledge regarding severe asthma, highlighting different molecular and immunological pathways that can be targeted for future therapeutic development. PMID:27367183

ESCMID guidelines for the management of the infection control measures to reduce transmission of multidrug-resistant Gram-negative bacteria in hospitalized patients.

PubMed

Tacconelli, E; Cataldo, M A; Dancer, S J; De Angelis, G; Falcone, M; Frank, U; Kahlmeter, G; Pan, A; Petrosillo, N; Rodríguez-Baño, J; Singh, N; Venditti, M; Yokoe, D S; Cookson, B

2014-01-01

Healthcare-associated infections due to multidrug-resistant Gram-negative bacteria (MDR-GNB) are a leading cause of morbidity and mortality worldwide. These evidence-based guidelines have been produced after a systematic review of published studies on infection prevention and control interventions aimed at reducing the transmission of MDR-GNB. The recommendations are stratified by type of infection prevention and control intervention and species of MDR-GNB and are presented in the form of 'basic' practices, recommended for all acute care facilities, and 'additional special approaches' to be considered when there is still clinical and/or epidemiological and/or molecular evidence of ongoing transmission, despite the application of the basic measures. The level of evidence for and strength of each recommendation, were defined according to the GRADE approach. © 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.

Mechanism and novel therapeutic approaches to wasting in chronic disease.

PubMed

Ebner, Nicole; Springer, Jochen; Kalantar-Zadeh, Kamyar; Lainscak, Mitja; Doehner, Wolfram; Anker, Stefan D; von Haehling, Stephan

2013-07-01

Cachexia is a multifactorial syndrome defined by continuous loss of skeletal muscle mass - with or without loss of fat mass - which cannot be fully reversed by conventional nutritional support and which may lead to progressive functional impairment and increased death risk. Its pathophysiology is characterized by negative protein and energy balance driven by a variable combination of reduced food intake and abnormal metabolism. Muscle wasting is encountered in virtually all chronic disease states in particular during advanced stages of the respective illness. Several pre-clinical and clinical studies are ongoing to ameliorate this clinical problem. The mechanisms of muscle wasting and cachexia in chronic diseases such as cancer, chronic heart failure, chronic obstructive pulmonary disease and chronic kidney disease are described. We discuss therapeutic targets and such potential modulators as appetite stimulants, selective androgen receptor modulators, amino acids and naturally occurring peptide hormones. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Clinical and Research Activities at the CATANA Facility of INFN-LNS: From the Conventional Hadrontherapy to the Laser-Driven Approach.

PubMed

Cirrone, Giuseppe A P; Cuttone, Giacomo; Raffaele, Luigi; Salamone, Vincenzo; Avitabile, Teresio; Privitera, Giuseppe; Spatola, Corrado; Margarone, Daniele; Patti, Valeria; Petringa, Giada; Romano, Francesco; Russo, Andrea; Russo, Antonio; Sabini, Maria G; Scuderi, Valentina; Schillaci, Francesco; Valastro, Lucia M

2017-01-01

The CATANA proton therapy center was the first Italian clinical facility making use of energetic (62 MeV) proton beams for the radioactive treatment of solid tumors. Since the date of the first patient treatment in 2002, 294 patients have been successful treated whose majority was affected by choroidal and iris melanomas. In this paper, we report on the current clinical and physical status of the CATANA facility describing the last dosimetric studies and reporting on the last patient follow-up results. The last part of the paper is dedicated to the description of the INFN-LNS ongoing activities on the realization of a beamline for the transport of laser-accelerated ion beams for future applications. The ELIMED (ELI-Beamlines MEDical and multidisciplinary applications) project is introduced and the main scientific aspects will be described.

Treatment Algorithms Based on Tumor Molecular Profiling: The Essence of Precision Medicine Trials.

PubMed

Le Tourneau, Christophe; Kamal, Maud; Tsimberidou, Apostolia-Maria; Bedard, Philippe; Pierron, Gaëlle; Callens, Céline; Rouleau, Etienne; Vincent-Salomon, Anne; Servant, Nicolas; Alt, Marie; Rouzier, Roman; Paoletti, Xavier; Delattre, Olivier; Bièche, Ivan

2016-04-01

With the advent of high-throughput molecular technologies, several precision medicine (PM) studies are currently ongoing that include molecular screening programs and PM clinical trials. Molecular profiling programs establish the molecular profile of patients' tumors with the aim to guide therapy based on identified molecular alterations. The aim of prospective PM clinical trials is to assess the clinical utility of tumor molecular profiling and to determine whether treatment selection based on molecular alterations produces superior outcomes compared with unselected treatment. These trials use treatment algorithms to assign patients to specific targeted therapies based on tumor molecular alterations. These algorithms should be governed by fixed rules to ensure standardization and reproducibility. Here, we summarize key molecular, biological, and technical criteria that, in our view, should be addressed when establishing treatment algorithms based on tumor molecular profiling for PM trials. © The Author 2015. Published by Oxford University Press.

Cell-based Therapy for Acute Organ Injury: Preclinical Evidence and On-going Clinical Trials Using Mesenchymal Stem Cells

PubMed Central

Monsel, Antoine; Zhu, Ying-gang; Gennai, Stephane; Hao, Qi; Liu, Jia; Lee, Jae W.

2014-01-01

Critically ill patients often suffer from multiple organ failures involving lung, kidney, liver or brain. Genomic, proteomic and metabolomic approaches highlight common injury mechanisms leading to acute organ failure. This underlines the need to focus on therapeutic strategies affecting multiple injury pathways. The use of adult stem cells such as mesenchymal stem or stromal cells (MSC) may represent a promising new therapeutic approach as increasing evidence shows that MSC can exert protective effects following injury through the release of pro-mitotic, anti-apoptotic, anti-inflammatory and immunomodulatory soluble factors. Furthermore, they can mitigate metabolomic and oxidative stress imbalance. In this work, we review the biological capabilities of MSC and the results of clinical trials using MSC as therapy in acute organ injuries. Although preliminary results are encouraging, more studies concerning safety and efficacy of MSC therapy are needed to determine their optimal clinical use. PMID:25211170

Cardiovascular point of care initiative: enhancements in clinical data management.

PubMed

Robertson, Jane

2003-01-01

The Department of Cardiovascular Surgery at East Alabama Medical Center (EAMC) initiated a program in 1996 to improve the quality and usefulness of clinical outcomes data. After years of using a commercial vendor product and enduring a tedious collection process, the department decided to develop its own tools to support quality improvement efforts. Using a hand-held personal data assistant (PDA), the team developed tools that allowed ongoing data collection at the point of care delivery. The tools and methods facilitated the collection of real time, accurate information that allowed EAMC to participate in multiple clinical quality initiatives. The ability to conduct rapid-cycle performance improvement studies propelled EAMC's Cardiovascular Surgery Program into the Top 100 as recognized by HCIA, now Solucient, for 3 consecutive years (1999-2001). This report will describe the evolution of the data collection process as well as the quality improvements that resulted.

Moving diabetes management from clinic to community: development of a prototype based on automated voice messaging.

PubMed

Piette, J D

1997-01-01

The purpose of this study is twofold. First, it provides a review of the literature supporting the development of a new service to help patients with diabetes and their providers manage their care. This service, automated voice messaging (AVM) with nurse follow-up, allows for systematic and intensive patient monitoring and diabetes education as well as a means of focusing clinical resources where they are most needed. Second, it provides a description of a prototype AVM-based diabetes management service that has been developed as part of two ongoing, randomized, controlled trials to test the efficacy of AVM care for patients with Type 2 diabetes. Preliminary findings from implementing this service in two large public healthcare systems suggest that AVM-supported care is feasible, desirable by clinicians and patients with diabetes, and may identify serious health problems that otherwise would go unnoted through standard means of clinic-based patient care.

GnRH antagonist versus long agonist protocols in IVF: a systematic review and meta-analysis accounting for patient type.

PubMed

Lambalk, C B; Banga, F R; Huirne, J A; Toftager, M; Pinborg, A; Homburg, R; van der Veen, F; van Wely, M

2017-09-01

Most reviews of IVF ovarian stimulation protocols have insufficiently accounted for various patient populations, such as ovulatory women, women with polycystic ovary syndrome (PCOS) or women with poor ovarian response, and have included studies in which the agonist or antagonist was not the only variable between the compared study arms. The aim of the current study was to compare GnRH antagonist protocols versus standard long agonist protocols in couples undergoing IVF or ICSI, while accounting for various patient populations and treatment schedules. The Cochrane Menstrual Disorders and Subfertility Review Group specialized register of controlled trials and Pubmed and Embase databases were searched from inception until June 2016. Eligible trials were those that compared GnRH antagonist protocols and standard long GnRH agonist protocols in couples undergoing IVF or ICSI. The primary outcome was ongoing pregnancy rate. Secondary outcomes were: live birth rate, clinical pregnancy rate, number of oocytes retrieved and safety with regard to ovarian hyperstimulation syndrome (OHSS). Separate comparisons were performed for the general IVF population, women with PCOS and women with poor ovarian response. Pre-planned subgroup analyses were performed for various antagonist treatment schedules. We included 50 studies. Of these, 34 studies reported on general IVF patients, 10 studies reported on PCOS patients and 6 studies reported on poor responders. In general IVF patients, ongoing pregnancy rate was significantly lower in the antagonist group compared with the agonist group (RR 0.89, 95% CI 0.82-0.96). In women with PCOS and in women with poor ovarian response, there was no evidence of a difference in ongoing pregnancy between the antagonist and agonist groups (RR 0.97, 95% CI 0.84-1.11 and RR 0.87, 95% CI 0.65-1.17, respectively). Subgroup analyses for various antagonist treatment schedules compared to the long protocol GnRH agonist showed a significantly lower ongoing pregnancy rate when the oral hormonal programming pill (OHP) pretreatment was combined with a flexible protocol (RR 0.74, 95% CI 0.59-0.91) while without OHP, the RR was 0.84, 95% CI 0.71-1.0. Subgroup analysis for the fixed antagonist schedule demonstrated no evidence of a significant difference with or without OHP (RR 0.94, 95% CI 0.79-1.12 and RR 0.94, 95% CI 0.83-1.05, respectively). Antagonists resulted in significantly lower OHSS rates both in the general IVF patients and in women with PCOS (RR 0.63, 95% CI 0.50-0.81 and RR 0.53, 95% CI 0.30-0.95, respectively). No data on OHSS was available from trials in poor responders. In a general IVF population, GnRH antagonists are associated with lower ongoing pregnancy rates when compared to long protocol agonists, but also with lower OHSS rates. Within this population, antagonist treatment prevents one case of OHSS in 40 patients but results in one less ongoing pregnancy out of every 28 women treated. Thus standard use of the long GnRH agonist treatment is perhaps still the approach of choice for prevention of premature luteinization. In couples with PCOS and poor responders, GnRH antagonists do not seem to compromise ongoing pregnancy rates and are associated with less OHSS and therefore could be considered as standard treatment. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

The role of clinical nurse educators in organ procurement organizations.

PubMed

Swain, Sharon

2011-12-01

Clinical nurse educators are advanced practice nurses with preparation at the master's level or higher. Such nurses play an important role in organ procurement organizations. As leaders and members of the team, they provide structure and design to the training process. These educators oversee orientation of new employees, serve as mentors to preceptors, assess the learning needs of the organization, and provide ongoing training to veteran staff. Clinical nurse educators also contribute to continuous quality improvement for the organization and help to comply with regulatory standards.

International developments in openEHR archetypes and templates.

PubMed

Leslie, Heather

Electronic Health Records (EHRs) are a complex knowledge domain. The ability to design EHRs to cope with the changing nature of health knowledge, and to be shareable, has been elusive. A recent pilot study1 tested the applicability of the CEN 13606 as an electronic health record standard. Using openEHR archetypes and tools2, 650 clinical content specifi cations (archetypes) were created (e.g. for blood pressure) and re-used across all clinical specialties and contexts. Groups of archetypes were aggregated in templates to support clinical information gathering or viewing (e.g. 80 separate archetypes make up the routine antenatal visit record). Over 60 templates were created for use in the emergency department, antenatal care and delivery of an infant, and paediatric hearing loss assessment. The primary goal is to define a logical clinical record architecture for the NHS but potentially, with archetypes as the keystone, shareable EHRs will also be attainable. Archetype and template development work is ongoing, with associated evaluation occurring in parallel.

Multicenter External Quality Assessment Program for PCR Detection of Mycobacterium ulcerans in Clinical and Environmental Specimens

PubMed Central

Eddyani, Miriam; Lavender, Caroline; de Rijk, Willem Bram; Bomans, Pieter; Fyfe, Janet; de Jong, Bouke; Portaels, Françoise

2014-01-01

Background Mycobacterium ulcerans is the causative agent of Buruli ulcer (BU), a necrotizing disease of the skin, soft tissue and bone. PCR is increasingly used in the diagnosis of BU and in research on the mode of transmission and environmental reservoir of M. ulcerans. Methodology/Principal Findings The aim of this study was to evaluate the performance of laboratories in detecting M. ulcerans using molecular tests in clinical and environmental samples by implementing sequential multicenter external quality assessment (EQA) programs. The second round of the clinical EQA program revealed somewhat improved performance. Conclusions/Significance Ongoing EQA programs remain essential and continued participation in future EQA programs by laboratories involved in the molecular testing of clinical and environmental samples for M. ulcerans for diagnostic and research purposes is strongly encouraged. Broad participation in such EQA programs also benefits the harmonization of quality in the BU research community and enhances the credibility of advances made in solving the transmission enigma of M. ulcerans. PMID:24586755

Prevalence of subclinical and undiagnosed overt hypothyroidism in a pregnancy loss clinic.

PubMed

Khalid, A S; Joyce, C; O'Donoghue, K

2013-04-01

Recent studies have associated pregnancy loss with subclinical hypothyroidism, defined as elevated thyroid-stimulating-hormone level, with normal free thyroxine. In overt hypothyroidism, the free thyroxine is low. Subclinical and overt hypothyroidism occurs in 0.25-2.5% and 0.2-0.3% of pregnancies respectively. We examined the prevalence of subclinical and undiagnosed overt hypothyroidism in women with recurrent miscarriage, late miscarriage and stillbirth attending the Pregnancy Loss Clinic. Data was collected from the Pregnancy Loss Clinic records. Women with sporadic miscarriages, autoimmune disorders, thrombophilias and known hypothyroidism were excluded. Two-hundred-and-sixty-two women were included. Median maternal age was 35 years (range 18-47). Subclinical and undiagnosed overt hypothyroidism was found in 11.45% of women. Twenty-two women (8.39%) had subclinical hypothyroidism, eight (3.05%) had undiagnosed overt hypothyroidism. Results were compared to women with ongoing pregnancies. A proportion of women attending the clinic had subclinical or undiagnosed overt hypothyroidism, raising the suspicion of causation in unexplained pregnancy loss.

Implementation and utilization of genetic testing in personalized medicine

PubMed Central

Abul-Husn, Noura S; Owusu Obeng, Aniwaa; Sanderson, Saskia C; Gottesman, Omri; Scott, Stuart A

2014-01-01

Clinical genetic testing began over 30 years ago with the availability of mutation detection for sickle cell disease diagnosis. Since then, the field has dramatically transformed to include gene sequencing, high-throughput targeted genotyping, prenatal mutation detection, preimplantation genetic diagnosis, population-based carrier screening, and now genome-wide analyses using microarrays and next-generation sequencing. Despite these significant advances in molecular technologies and testing capabilities, clinical genetics laboratories historically have been centered on mutation detection for Mendelian disorders. However, the ongoing identification of deoxyribonucleic acid (DNA) sequence variants associated with common diseases prompted the availability of testing for personal disease risk estimation, and created commercial opportunities for direct-to-consumer genetic testing companies that assay these variants. This germline genetic risk, in conjunction with other clinical, family, and demographic variables, are the key components of the personalized medicine paradigm, which aims to apply personal genomic and other relevant data into a patient’s clinical assessment to more precisely guide medical management. However, genetic testing for disease risk estimation is an ongoing topic of debate, largely due to inconsistencies in the results, concerns over clinical validity and utility, and the variable mode of delivery when returning genetic results to patients in the absence of traditional counseling. A related class of genetic testing with analogous issues of clinical utility and acceptance is pharmacogenetic testing, which interrogates sequence variants implicated in interindividual drug response variability. Although clinical pharmacogenetic testing has not previously been widely adopted, advances in rapid turnaround time genetic testing technology and the recent implementation of preemptive genotyping programs at selected medical centers suggest that personalized medicine through pharmacogenetics is now a reality. This review aims to summarize the current state of implementing genetic testing for personalized medicine, with an emphasis on clinical pharmacogenetic testing. PMID:25206309

Implementing a fax referral program for quitline smoking cessation services in urban health centers: a qualitative study.

PubMed

Cantrell, Jennifer; Shelley, Donna

2009-12-17

Fax referral services that connect smokers to state quitlines have been implemented in 49 U.S. states and territories and promoted as a simple solution to improving smoker assistance in medical practice. This study is an in-depth examination of the systems-level changes needed to implement and sustain a fax referral program in primary care. The study involved implementation of a fax referral system paired with a chart stamp prompting providers to identify smoking patients, provide advice to quit and refer interested smokers to a state-based fax quitline. Three focus groups (n = 26) and eight key informant interviews were conducted with staff and physicians at two clinics after the intervention. We used the Chronic Care Model as a framework to analyze the data, examining how well the systems changes were implemented and the impact of these changes on care processes, and to develop recommendations for improvement. Physicians and staff described numerous benefits of the fax referral program for providers and patients but pointed out significant barriers to full implementation, including the time-consuming process of referring patients to the Quitline, substantial patient resistance, and limitations in information and care delivery systems for referring and tracking smokers. Respondents identified several strategies for improving integration, including simplification of the referral form, enhanced teamwork, formal assignment of responsibility for referrals, ongoing staff training and patient education. Improvements in Quitline feedback were needed to compensate for clinics' limited internal information systems for tracking smokers. Establishing sustainable linkages to quitline services in clinical sites requires knowledge of existing patterns of care and tailored organizational changes to ensure new systems are prioritized, easily integrated into current office routines, formally assigned to specific staff members, and supported by internal systems that ensure adequate tracking and follow up of smokers. Ongoing staff training and patient self-management techniques are also needed to ease the introduction of new programs and increase their acceptability to smokers.

Existing data sources for clinical epidemiology: Scandinavian Cohort for osteonecrosis of the jaw – work in progress and challenges

PubMed Central

Schiodt, Morten; Larsson Wexell, Cecilia; Herlofson, Bente Brokstad; Giltvedt, Karen Marie; Norholt, Sven Erik; Ehrenstein, Vera

2015-01-01

Osteonecrosis of the jaw (ONJ) is a severe side effect associated with antiresorptive treatment. Monitoring of ONJ using routine databases in Scandinavian countries is a challenge owing to lack of valid algorithms and to heterogeneous referral practices. The aim of this paper is to describe the process of establishing a Scandinavian ONJ Cohort enrolling all ONJ cases related to antiresorptive treatment arising in Denmark, Norway, and Sweden between 2011 and 2019. The initial purpose of the cohort is to support an ongoing pharmacovigilance study of denosumab and zoledronic acid in Denmark, Norway, and Sweden. The three countries, with their 199 clinics, departments, and units of oral and maxillofacial surgery, both hospital-based and freestanding, differ somewhat in referral practices of the ONJ patients. By directly contacting all providers of care to ONJ patients in the three countries, we established a network for reporting incident cases to each country’s research database directly or through a member of the Scandinavian ONJ task force as a liaison. The task force includes a Scandinavian coordinator and three national coordinators collaborating directly with the clinics. A uniform ONJ registration form has been developed, and the relevant medical community has been informed either directly or through presentations at professional meetings. A website with study information is published in each country, and data entry is ongoing. This large-scale systematic uniform registration of ONJ cases in Denmark, Norway, and Sweden, with an underlying total population of more than 20 million people, merged into the Scandinavian ONJ Cohort, will contribute to better knowledge and understanding of this challenging group of patients, and ultimately, help improve patient care. The Scandinavian ONJ Cohort as a whole and its component national ONJ research databases may offer the potential for large-scale multinational intervention and safety studies in the future. PMID:25657594

Evidence-Responsiveness and the Ongoing Autonomy of Treatment Preferences.

PubMed

Weimer, Steven

2017-06-14

To be an autonomous agent is to determine one's own path in life. However, this cannot plausibly be seen as a one-off affair. An autonomous agent does not merely set herself on a particular course and then lock the steering wheel in place, so to speak, but must maintain some form of ongoing control over her direction in life-must keep her eyes on the road and her hands on the wheel. Circumstances often change in important and unexpected ways, after all, and it is reasonable to think that a crucial part of autonomy consists of the ability and disposition to recognize and properly respond to such changes. This implies, I contend, that a patient whose initial decision to undergo a given treatment satisfied plausible requirements of autonomy, but who is now unable to recognize that available evidence indicates the need to reconsider her medical situation and options has come to lack autonomy with respect to her desire to continue that treatment. However, and despite its importance with respect to both theoretical understandings of autonomy and applications of the concept to clinical ethics, this ongoing aspect of autonomy has received little attention. This paper aims to go some way toward remedying that. I first critically review two of the few theories of autonomy that do address "evidence-responsiveness" so as to identify and elaborate what I take to be the most promising way in which to account for this aspect of autonomy. After considering and responding to a possible objection to the evidence-responsiveness condition I propose, I conclude by discussing its clinical implications. That condition, I argue, is not merely theoretically sound, but can and should be applied to clinical practice.

Guidelines for Adolescent Depression in Primary Care (GLAD-PC): Part II. Treatment and Ongoing Management.

PubMed

Cheung, Amy H; Zuckerbrot, Rachel A; Jensen, Peter S; Laraque, Danielle; Stein, Ruth E K

2018-02-26

To update clinical practice guidelines to assist primary care (PC) in the screening and assessment of depression. In this second part of the updated guidelines, we address treatment and ongoing management of adolescent depression in the PC setting. By using a combination of evidence- and consensus-based methodologies, the guidelines were updated in 2 phases as informed by (1) current scientific evidence (published and unpublished) and (2) revision and iteration among the steering committee, including youth and families with lived experience. These updated guidelines are targeted for youth aged 10 to 21 years and offer recommendations for the management of adolescent depression in PC, including (1) active monitoring of mildly depressed youth, (2) treatment with evidence-based medication and psychotherapeutic approaches in cases of moderate and/or severe depression, (3) close monitoring of side effects, (4) consultation and comanagement of care with mental health specialists, (5) ongoing tracking of outcomes, and (6) specific steps to be taken in instances of partial or no improvement after an initial treatment has begun. The strength of each recommendation and the grade of its evidence base are summarized. The Guidelines for Adolescent Depression in Primary Care cannot replace clinical judgment, and they should not be the sole source of guidance for adolescent depression management. Nonetheless, the guidelines may assist PC clinicians in the management of depressed adolescents in an era of great clinical need and a shortage of mental health specialists. Additional research concerning the management of depressed youth in PC is needed, including the usability, feasibility, and sustainability of guidelines, and determination of the extent to which the guidelines actually improve outcomes of depressed youth. Copyright © 2018 by the American Academy of Pediatrics.

Bcl-2 antisense therapy in B-cell malignancies.

PubMed

Chanan-Khan, Asher

2005-07-01

Bcl-2 is an apoptosis regulating protein, overexpression of which is associated with chemotherapy resistant disease, aggressive clinical course, and poor survival in patients with B-cell lymphoproliferative disorders. Overexpression of Bcl-2 protein results in an aberrant intrinsic apoptotic pathway that confers a protective effect on malignant cells against a death signal (e.g., chemotherapy or radiotherapy). Downregulation of this oncoprotein, thus, represents a possible new way to target clinically aggressive disease. Preclinical studies have shown that this oncoprotein can be effectively decreased by Bcl-2 antisense in malignant lymphoid cells and can reverse chemotherapy resistance, as well as enhance the anti-apoptotic potential of both chemotherapeutic and biologic agents. Ongoing clinical trials are exploring the role of Bcl-2 downregulation with oblimersen (Bcl-2 antisense) in patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia and multiple myeloma. Early results from these studies are promising and support the proof of the principle. As these studies are completed and mature data emerges, the role of Bcl-2 antisense therapy in the treatment of B-cell malignancies will become clearer.

Can monaural temporal masking explain the ongoing precedence effect?

PubMed

Freyman, Richard L; Morse-Fortier, Charlotte; Griffin, Amanda M; Zurek, Patrick M

2018-02-01

The precedence effect for transient sounds has been proposed to be based primarily on monaural processes, manifested by asymmetric temporal masking. This study explored the potential for monaural explanations with longer ("ongoing") sounds exhibiting the precedence effect. Transient stimuli were single lead-lag noise burst pairs; ongoing stimuli were trains of 63 burst pairs. Unlike with transients, monaural masking data for ongoing sounds showed no advantage for the lead, and are inconsistent with asymmetric audibility as an explanation for ongoing precedence. This result, along with supplementary measurements of interaural time discrimination, suggests different explanations for transient and ongoing precedence.

Using 'WeChat' online social networking in a real-world needs analysis of family members of youths at clinical high risk of psychosis.

PubMed

Zhang, TianHong; Xu, LiHua; Tang, YingYing; Cui, HuiRu; Li, HuiJun; Wei, YanYan; Xu, YangYang; Jiang, LiJuan; Zhu, YiKang; Li, ChunBo; Jiang, KaiDa; Xiao, ZePing; Wang, JiJun

2018-04-01

The argument surrounding the safety and effectiveness of interventions for the population of individuals at a clinical high risk of developing psychosis has been ongoing for the past 30 years. However, few studies have assessed the needs of this special young population, who are struggling with the recent onset of psychotic symptoms. The sample consisted of 171 family members of 108 clinical high-risk individuals included from the ShangHai at Risk for Psychosis research programme. A 'WeChat' group was established to provide mutual support. There were 22,007 valid messages sent within the group between 1 April 2015 and 27 June 2016. Chat records were subsequently analysed to determine the needs of families during intervention at the early stages of psychosis. Families of clinical high-risk individuals were highly involved in the entire medical process, and the major concerns of the families of clinical high-risk individuals focused on both functional recovery and medication. The themes of 'take medication', 'go to school' and 'study in school' were often discussed within the group. A family-focused intervention targeting functional recovery and real-time professional explanations of medication would meet the major needs of families of Chinese clinical high-risk individuals.

Hope for a cure and altruism are the main motives behind participation in phase 3 clinical cancer trials.

PubMed

Godskesen, T; Hansson, M G; Nygren, P; Nordin, K; Kihlbom, U

2015-01-01

It is necessary to carry out randomised clinical cancer trials (RCTs) in order to evaluate new, potentially useful treatments for future cancer patients. Participation in clinical trials plays an important role in determining whether a new treatment is the best therapy or not. Therefore, it is important to understand on what basis patients decide to participate in clinical trials and to investigate the implications of this understanding for optimising the information process related to study participation. The aims of this study were to (1) describe motives associated with participation in RCTs, (2) assess if patients comprehend the information related to trial enrolment, and (3) describe patient experiences of trial participation. Questionnaires were sent to 96 cancer patients participating in one of nine ongoing clinical phase 3 trials at the Department of Oncology, Uppsala University Hospital in Sweden. Eighty-eight patients completed the questionnaire (response rate 92%); 95% of these were patients in adjuvant therapy and 5% participated in clinical trials on palliative care. Two main reasons for participation were identified: personal hope for a cure and altruism. Patients show adequate understanding of the information provided to them in the consent process and participation entails high patient satisfaction. © 2014 John Wiley & Sons Ltd.

Bayesian accrual prediction for interim review of clinical studies: open source R package and smartphone application.

PubMed

Jiang, Yu; Guarino, Peter; Ma, Shuangge; Simon, Steve; Mayo, Matthew S; Raghavan, Rama; Gajewski, Byron J

2016-07-22

Subject recruitment for medical research is challenging. Slow patient accrual leads to increased costs and delays in treatment advances. Researchers need reliable tools to manage and predict the accrual rate. The previously developed Bayesian method integrates researchers' experience on former trials and data from an ongoing study, providing a reliable prediction of accrual rate for clinical studies. In this paper, we present a user-friendly graphical user interface program developed in R. A closed-form solution for the total subjects that can be recruited within a fixed time is derived. We also present a built-in Android system using Java for web browsers and mobile devices. Using the accrual software, we re-evaluated the Veteran Affairs Cooperative Studies Program 558- ROBOTICS study. The application of the software in monitoring and management of recruitment is illustrated for different stages of the trial. This developed accrual software provides a more convenient platform for estimation and prediction of the accrual process.

Developmental capacity of in vitro-matured human oocytes retrieved from polycystic ovary syndrome ovaries containing no follicles larger than 6 mm.

PubMed

Guzman, Luis; Ortega-Hrepich, Carolina; Albuz, Firas K; Verheyen, Greta; Devroey, Paul; Smitz, Johan; De Vos, Michel

2012-08-01

To test the developmental competence of oocytes in a nonhCG-triggered in vitro maturation (IVM) system when oocyte-cumulus complexes (OCC) are retrieved from antral follicles with a diameter of <6 mm. Prospective cohort study. Tertiary university-based referral center. From January 2010 to September 2011, 121 patients with polycystic ovaries/polycystic ovary syndrome underwent 239 IVM cycles in total. In 58 of these cycles (44 patients), all antral follicles had a diameter of <6 mm on the day of oocyte retrieval. NonhCG-triggered IVM of oocytes, fresh or vitrified/warmed embryo transfer (ET). Oocyte diameter, maturation rate, fertilization rate, embryo development and morphology, implantation rate, clinical pregnancy rate, ongoing pregnancy rate. Oocyte retrieval yielded 16.7 OCC/cycle, and 50.8% of oocytes completed IVM. The mean oocyte diameter increased from 108.8 ± 4.3 μm to 111.9 ± 4.1 μm after IVM. Mean fertilization rate was 63.7%, and 45.4% of 2-pronuclei oocytes developed into a morphologically good-quality embryo on day 3 after intracytoplasmic sperm injection. Fresh ET resulted in two ongoing pregnancies (2/37; 5.4%). Deferred vitrified-warmed ET led to an ongoing pregnancy rate of 34.6% (9/24). Three healthy babies were born and eight pregnancies were still ongoing. Oocytes retrieved from follicles with a diameter of <6 mm grow during a 40-hour IVM culture can acquire full competence in vitro, as illustrated by their development into healthy offspring. Endometrial quality appears to be a crucial determinant of pregnancy after nonhCG-triggered IVM. Copyright © 2012 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Mental health nurses' views about antipsychotic medication side effects.

PubMed

Stomski, N J; Morrison, P; Meehan, T

2016-08-01

WHAT IS KNOWN ON THE SUBJECT?: The only previous quantitative study that examined nurses' use of assessment tools to identify antipsychotic medication side effects found that about 25% of mental health nurses were using assessment tools. No previous studies have examined factors that influence the manner in which mental health nurses assess antipsychotic medication side effects. WHAT THIS PAPER ADDS TO EXISTING KNOWLEDGE?: One-third of the respondents were not aware of any antipsychotic medication side-effect assessment tool, and only one-quarter were currently using an assessment tool. 'Service responsibility' was significantly associated with ongoing use of antipsychotic medication assessment tools, indicating that respondents with more positive attitudes to their service were more likely to continue using antipsychotic medication assessment tools. WHAT ARE THE IMPLICATIONS FOR PRACTICE?: The low level of awareness and use of antipsychotic medication side-effect assessment tools indicates that nursing educational institutions should incorporate more detail about these tools in course content, and emphasize in particular the benefits that result from the use of these tools in clinical practice. Service processes contributed significantly to the use of antipsychotic medication assessment tools, which indicates that managers need to foster workplace cultures that promote routine use of these tools. Introduction Limited evidence suggests that only a minority of mental health nurses regularly use standardized assessment tools to assess antipsychotic medication side effects, but the factors that contribute to the non-routine use of these tools remain unknown. Aim To examine Australian mental health nurses' awareness of, and attitudes towards, side-effect assessment tools, and also identify factors the influence the use of these tools. Methods A cross-sectional survey was undertaken through distributing an online questionnaire via email to members of the Australian College of Mental Health Nurses. Completed questionnaires were received from 171 respondents. Linear regression was used to examine the relationship between the 'service responsibility' and 'personal confidence' scale scores, and awareness, previous use and ongoing use of antipsychotic medication assessment tools. Results Only one-quarter of the respondents (26.5%) were currently using an assessment tool. 'Service responsibility' was significantly associated with ongoing use of antipsychotic medication assessment tools (Β = 3.26; 95% CI 0.83-5.69). 'Personal confidence' did not influence the ongoing use of assessment tools (Β = -0.05; 95% CI -1.06-1.50). Implications for clinical practice Stakeholders can incorporate 'service responsibility' processes to foster increased use of assessment tools, which may enhance the identification antipsychotic medication side effects and improve the quality of care for service users. © 2016 John Wiley & Sons Ltd.

Sportsman hernia; the review of current diagnosis and treatment modalities

PubMed Central

Paksoy, Melih; Sekmen, Ümit

2016-01-01

Groin pain is an important clinical entity that may affect a sportsman’s active sports life. Sportsman’s hernia is a chronic low abdominal and groin pain syndrome. Open and laparoscopic surgical treatment may be chosen in case of conservative treatment failure. Studies on sportsman’s hernia, which is a challenging situation in both diagnosis and treatment, are ongoing in many centers. We reviewed the treatment results of 37 patients diagnosed and treated as sportsman’s hernia at our hospital between 2011–2014, in light of current literature. PMID:27436937

Clinical Study of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) for Severe Pelvic Fracture and Intra-Abdominal Hemorrhagic Shock Using Continuous Vital Signs

DTIC Science & Technology

2017-03-01

University of Maryland, Baltimore Baltimore, MD 21201 REPORT DATE: March 2017 TYPE OF REPORT: Annual PREPARED FOR: U.S. Army Medical Research ...ongoing. After FDA approval of a new novel REBOA catheter (ER-REBOATM (Prytime Medical , Boerne, TX )) in October 2015, we incorporated this catheter into...Scalea, MD 39th Annual CONFERENCE ON SHOCK – June 11-14th, Austin , TX 2. REBOA IMPROVES MEAN BLOOD PRESSURE (MBP) AND SHOCK INDEX (SI) AS MEASURED

Coding in Muscle Disease.

PubMed

Jones, Lyell K; Ney, John P

2016-12-01

Accurate coding is critically important for clinical practice and research. Ongoing changes to diagnostic and billing codes require the clinician to stay abreast of coding updates. Payment for health care services, data sets for health services research, and reporting for medical quality improvement all require accurate administrative coding. This article provides an overview of administrative coding for patients with muscle disease and includes a case-based review of diagnostic and Evaluation and Management (E/M) coding principles in patients with myopathy. Procedural coding for electrodiagnostic studies and neuromuscular ultrasound is also reviewed.

Nutraceuticals for prostate cancer chemoprevention: from molecular mechanisms to clinical application.

PubMed

Wang, Zhijun; Fan, Jeffery; Liu, Mandy; Yeung, Steven; Chang, Andy; Chow, Moses S S; Pon, Doreen; Huang, Ying

2013-12-01

Nutraceutical is a food, or part of a food, used for the prevention and/or treatment of diseases. A number of nutraceuticals serve as candidates for development of prostate cancer chemopreventive agents because of promising epidemiological, preclinical and pilot clinical findings. Their mechanisms of action may involve an ability to target multiple molecular pathways in carcinogenesis without eliciting toxic side effects. This review provides an overview of several nutraceuticals, including green tea polyphenol, omega-3 fatty acids, vitamin D, lycopene, genistein, quercetin, resveratrol and sulforaphane, for the clinical relevance to chemoprevention of prostate cancer. Their mechanisms of action on regulating key processes of carcinogenesis are also discussed. For each of these agents, a brief summary of completed or currently ongoing clinical trials related to the chemopreventive efficacy on prostate cancer is given. Even though a few clinical trials have been conducted, review of these results indicate that further studies are required to confirm the clinical efficacy and safety, and to provide a guidance on how to use nutraceuticals for optimal effect. Future cancer prevention clinical trials for the nutraceuticals should recruit men with an increased risk of prostate cancer.

Idiopathic inflammatory myositis.

PubMed

Tieu, Joanna; Lundberg, Ingrid E; Limaye, Vidya

2016-02-01

Knowledge on idiopathic inflammatory myopathy (IIM) has evolved with the identification of myositis-associated and myositis-specific antibodies, development of histopathological classification and the recognition of how these correlate with clinical phenotype and response to therapy. In this paper, we outline key advances in diagnosis and histopathology, including the more recent identification of antibodies associated with immune-mediated necrotising myopathy (IMNM) and inclusion body myositis (IBM). Ongoing longitudinal observational cohorts allow further classification of these patients with IIM, their predicted clinical course and response to specific therapies. Registries have been developed worldwide for this purpose. A challenging aspect in IIM, a multisystem disease with multiple clinical subtypes, has been defining disease status and clinically relevant improvement. Tools for assessing activity and damage are now recognised to be important in determining disease activity and guiding therapeutic decision-making. The International Myositis Assessment and Clinical Studies (IMACS) group has developed such tools for use in research and clinical settings. There is limited evidence for specific treatment strategies in IIM. With significant development in the understanding of IIM and improved classification, longitudinal observational cohorts and trials using validated outcome measures are necessary, to provide important information for evidence-based care in the clinical setting. Crown Copyright © 2016. Published by Elsevier Ltd. All rights reserved.

Validation of Mismatch Negativity and P3a for Use in Multi-Site Studies of Schizophrenia: Characterization of Demographic, Clinical, Cognitive, and Functional Correlates in COGS-2

PubMed Central

Light, Gregory A.; Swerdlow, Neal R.; Thomas, Michael L.; Calkins, Monica E.; Green, Michael F.; Greenwood, Tiffany A.; Gur, Raquel E.; Gur, Ruben C.; Lazzeroni, Laura C.; Nuechterlein, Keith H.; Pela, Marlena; Radant, Allen D.; Seidman, Larry J.; Sharp, Richard F.; Siever, Larry J.; Silverman, Jeremy M.; Sprock, Joyce; Stone, William S.; Sugar, Catherine A.; Tsuang, Debby W.; Tsuang, Ming T.; Braff, David L.; Turetsky, Bruce I.

2014-01-01

Mismatch negativity (MMN) and P3a are auditory event-related potential (ERP) components that show robust deficits in schizophrenia (SZ) patients and exhibit qualities of endophenotypes, including substantial heritability, test-retest reliability, and trait-like stability. These measures also fulfill criteria for use as cognition and function-linked biomarkers in outcome studies, but have not yet been validated for use in large-scale multi-site clinical studies. This study tested the feasibility of adding MMN and P3a to the ongoing Consortium on the Genetics of Schizophrenia (COGS) study. The extent to which demographic, clinical, cognitive, and functional characteristics contribute to variability in MMN and P3a amplitudes was also examined. Participants (HCS n=824, SZ n=966) underwent testing at 5 geographically distributed COGS laboratories. Valid ERP data was obtained from 91% of HCS and 91% of SZ patients. Highly significant MMN (d=0.96) and P3a (d=0.93) amplitude reductions were observed in SZ patients, comparable in magnitude to those observed in single-lab studies with no appreciable differences across laboratories. Demographic characteristics accounted for 26% and 18% of the variance in MMN and P3a amplitudes, respectively. Significant relationships were observed among demographically-adjusted MMN and P3a measures and medication status as well as several clinical, cognitive, and functional characteristics of the SZ patients. This study demonstrates that MMN and P3a ERP biomarkers can be feasibly used in multi-site clinical studies. As with many clinical tests of brain function, demographic factors contribute to MMN and P3a amplitudes and should be carefully considered in future biomarker-informed clinical studies. PMID:25449710

Validation of mismatch negativity and P3a for use in multi-site studies of schizophrenia: characterization of demographic, clinical, cognitive, and functional correlates in COGS-2.

PubMed

Light, Gregory A; Swerdlow, Neal R; Thomas, Michael L; Calkins, Monica E; Green, Michael F; Greenwood, Tiffany A; Gur, Raquel E; Gur, Ruben C; Lazzeroni, Laura C; Nuechterlein, Keith H; Pela, Marlena; Radant, Allen D; Seidman, Larry J; Sharp, Richard F; Siever, Larry J; Silverman, Jeremy M; Sprock, Joyce; Stone, William S; Sugar, Catherine A; Tsuang, Debby W; Tsuang, Ming T; Braff, David L; Turetsky, Bruce I

2015-04-01

Mismatch negativity (MMN) and P3a are auditory event-related potential (ERP) components that show robust deficits in schizophrenia (SZ) patients and exhibit qualities of endophenotypes, including substantial heritability, test-retest reliability, and trait-like stability. These measures also fulfill criteria for use as cognition and function-linked biomarkers in outcome studies, but have not yet been validated for use in large-scale multi-site clinical studies. This study tested the feasibility of adding MMN and P3a to the ongoing Consortium on the Genetics of Schizophrenia (COGS) study. The extent to which demographic, clinical, cognitive, and functional characteristics contribute to variability in MMN and P3a amplitudes was also examined. Participants (HCS n=824, SZ n=966) underwent testing at 5 geographically distributed COGS laboratories. Valid ERP recordings were obtained from 91% of HCS and 91% of SZ patients. Highly significant MMN (d=0.96) and P3a (d=0.93) amplitude reductions were observed in SZ patients, comparable in magnitude to those observed in single-lab studies with no appreciable differences across laboratories. Demographic characteristics accounted for 26% and 18% of the variance in MMN and P3a amplitudes, respectively. Significant relationships were observed among demographically-adjusted MMN and P3a measures and medication status as well as several clinical, cognitive, and functional characteristics of the SZ patients. This study demonstrates that MMN and P3a ERP biomarkers can be feasibly used in multi-site clinical studies. As with many clinical tests of brain function, demographic factors contribute to MMN and P3a amplitudes and should be carefully considered in future biomarker-informed clinical studies. Published by Elsevier B.V.

Evaluation Procedures for Training Psychotherapists in Interpersonal Psychotherapy (IPT).

ERIC Educational Resources Information Center

Chevron, Eve S.; And Others

The training of psychotherapists has been an ongoing process in psychiatry and clinical psychology. Recently, however, a growing demand to operationalize competence criteria to enable independent evaluation of therapists' skills in specifically defined psychotherapies has occurred. To examine this phenomenon, evaluation procedures were developed…

32 CFR 199.6 - TRICARE-authorized providers.

Code of Federal Regulations, 2013 CFR

2013-07-01

... itemized fully and sufficiently descriptive for the CHAMPUS to make a determination of benefits. (B... evaluate all functions of the RTC and contribute to an ongoing process of program improvement. The clinical... multidisciplinary safety committee. (8) Facility evaluation. The RTC annually evaluates accomplishment of the goals...

32 CFR 199.6 - TRICARE-authorized providers.

Code of Federal Regulations, 2010 CFR

2010-07-01

... itemized fully and sufficiently descriptive for the CHAMPUS to make a determination of benefits. (B... evaluate all functions of the RTC and contribute to an ongoing process of program improvement. The clinical... multidisciplinary safety committee. (8) Facility evaluation. The RTC annually evaluates accomplishment of the goals...

32 CFR 199.6 - TRICARE-authorized providers.

Code of Federal Regulations, 2011 CFR

2011-07-01

... itemized fully and sufficiently descriptive for the CHAMPUS to make a determination of benefits. (B... evaluate all functions of the RTC and contribute to an ongoing process of program improvement. The clinical... multidisciplinary safety committee. (8) Facility evaluation. The RTC annually evaluates accomplishment of the goals...

32 CFR 199.6 - TRICARE-authorized providers.

Code of Federal Regulations, 2012 CFR

2012-07-01

... itemized fully and sufficiently descriptive for the CHAMPUS to make a determination of benefits. (B... evaluate all functions of the RTC and contribute to an ongoing process of program improvement. The clinical... multidisciplinary safety committee. (8) Facility evaluation. The RTC annually evaluates accomplishment of the goals...

32 CFR 199.6 - TRICARE-authorized providers.

Code of Federal Regulations, 2014 CFR

2014-07-01

... itemized fully and sufficiently descriptive for the CHAMPUS to make a determination of benefits. (B... evaluate all functions of the RTC and contribute to an ongoing process of program improvement. The clinical... multidisciplinary safety committee. (8) Facility evaluation. The RTC annually evaluates accomplishment of the goals...

Participants with schizophrenia retain the information necessary for informed consent during clinical trials

PubMed Central

Fischer, Bernard A.; McMahon, Robert P.; Meyer, Walter A.; Slack, Daniel J.; Appelbaum, Paul S.; Carpenter, William T.

2015-01-01

Objective Cognitive impairment is a characteristic of schizophrenia. This impairment may affect the retention of information required for ongoing knowledgeable participation in clinical trials. This study monitored retention of study-related knowledge--including assessment of therapeutic misconception--in people with stable, DSM-IV schizophrenia during participation in placebo-controlled clinical trials of adjunctive agents. Stability was defined as being on an antipsychotic with no change in medication or dose over the previous 4 weeks. Method Individuals enrolling in one of seven clinical trials were approached for participation. Participants came from research clinics and community mental health centers. At baseline, clinical trial consent forms were reviewed and study knowledge assessed. Participants were randomized to follow-up assessments at weeks 1, 4, and 8; weeks 4 and 8; or at week 8 only. Clinical trial consent forms were not re-reviewed at any follow-up visit. Results Fifty-nine participants were enrolled; analysis included 52 participants with at least one follow-up visit. Study knowledge did not decrease meaningfully in any group. Therapeutic misconception was not observed in participants during the study. The group assessed most frequently demonstrated significant improvement over baseline (t44= 3.43, p= 0.001). Retention of study knowledge was not related to symptoms, but had a weak correlation with cognitive capacity (R= 0.28, p= 0.07). Performance did not differ between participants from research clinics and those from community mental health centers. Conclusions Clinically-stable people with schizophrenia enrolling in a placebo-controlled adjunctive medication study, once determined to have capacity to consent to a clinical trial, retained appropriate study knowledge for at least 8 weeks. In the absence of a specific reason to suspect a loss of decisional capacity, there appears to be no need to routinely re-evaluate participants during this type of clinical trial. PMID:23842013

Witnessing intimate partner violence as a child does not increase the likelihood of becoming an adult intimate partner violence victim.

PubMed

Ernst, Amy A; Weiss, Steven J; Del Castillo, Christie; Aagaard, Jaime; Marvez-Valls, Eduardo; D'Angelo, Juliet; Combs, Shanna; Feuchter, Alexander; Hegyi, Michael; Clark, Ross; Coffman, Brittany

2007-05-01

To determine whether adults who witnessed intimate partner violence (IPV) as children would have an increased rate of being victims of ongoing IPV, as measured by the Ongoing Violence Assessment Tool (OVAT), compared with adult controls who did not witness IPV as children. The authors also sought to determine whether there were differences in demographics in these two groups. This was a cross sectional cohort study of patients presenting to a high-volume academic emergency department. Emergency department patients presenting from November 16, 2005, to January 5, 2006, during 46 randomized four-hour shifts were included. A confidential computer touch-screen data entry program was used for collecting demographic data, including witnessing IPV as a child and the OVAT. Main outcome measures were witnessing IPV as a child, ongoing IPV, and associated demographics. Assuming a prevalence of IPV of 20% and a clinically significant difference of 20% between adults who witnessed IPV as children and adult controls who did not witness IPV as children, the study was powered at 80%, with 215 subjects included. A total of 280 subjects were entered; 256 had complete data sets. Forty-nine percent of subjects were male, 45% were Hispanic, 72 (28%) were adults who witnessed IPV as children, and 184 (72%) were adult controls who did not witness IPV as children. Sixty-three (23.5%) were positive for ongoing IPV. There was no correlation of adults who witnessed IPV as children with the presence of ongoing IPV, as determined by univariate and bivariate analysis. Twenty-three of 72 (32%) of the adults who witnessed IPV as children, and 39 of 184 (21%) of the adult controls who did not witness IPV as children, were positive for IPV (difference, 11%; 95% confidence interval [CI] = -2% to 23%). Significant correlations with having witnessed IPV as a child included age younger than 40 years (odds ratio [OR], 4.2; 95% CI = 1.7 to 9.1), income less than $20,000/year (OR, 5.1; 95% CI = 1.6 to 12.5), and abuse as a child (OR, 9.1; 95% CI = 4.2 to 19.6). Other demographics were not significantly correlated with having witnessed IPV as a child. Adults who witnessed IPV as children were more likely to have a lower income, be younger, and have been abused as a child, but not more likely to be positive for ongoing IPV, when compared with patients who had not witnessed IPV.

Protein kinase inhibitors against malignant lymphoma

PubMed Central

D’Cruz, Osmond J; Uckun, Fatih M

2013-01-01

Introduction Tyrosine kinases (TKs) are intimately involved in multiple signal transduction pathways regulating survival, activation, proliferation and differentiation of lymphoid cells. Deregulation or overexpression of specific oncogenic TKs is implicated in maintaining the malignant phenotype in B-lineage lymphoid malignancies. Several novel targeted TK inhibitors (TKIs) have recently emerged as active in the treatment of relapsed or refractory B-cell lymphomas that inhibit critical signaling pathways, promote apoptotic mechanisms or modulate the tumor microenvironment. Areas covered In this review, the authors summarize the clinical outcomes of newer TKIs in various B-cell lymphomas from published and ongoing clinical studies and abstracts from major cancer and hematology conferences. Expert opinion Multiple clinical trials have demonstrated that robust antitumor activity can be obtained with TKIs directed toward specific oncogenic TKs that are genetically deregulated in various subtypes of B-cell lymphomas. Clinical success of targeting TKIs is dependent upon on identifying reliable molecular and clinical markers associated with select cohorts of patients. Further understanding of the signaling pathways should stimulate the identification of novel molecular targets and expand the development of new therapeutic options and individualized therapies. PMID:23496343

MODUL-a multicenter randomized clinical trial of biomarker-driven maintenance therapy following first-line standard induction treatment of metastatic colorectal cancer: an adaptable signal-seeking approach.

PubMed

Schmoll, Hans-Joachim; Arnold, Dirk; de Gramont, Aimery; Ducreux, Michel; Grothey, Axel; O'Dwyer, Peter J; Van Cutsem, Eric; Hermann, Frank; Bosanac, Ivan; Bendahmane, Belguendouz; Mancao, Christoph; Tabernero, Josep

2018-06-01

The old approach of one therapeutic for all patients with mCRC is evolving with a need to target specific molecular aberrations or cell-signalling pathways. Molecular screening approaches and new biomarkers are required to fully characterize tumours, identify patients most likely to benefit, and predict treatment response. MODUL is a signal-seeking trial with a design that is highly adaptable, permitting modification of different treatment cohorts and inclusion of further additional cohorts based on novel evidence on new compounds/combinations that emerge during the study. MODUL is ongoing and its adaptable nature permits timely and efficient recruitment of patients into the most appropriate cohort. Recruitment will take place over approximately 5 years in Europe, Asia, Africa, and South America. The design of MODUL with ongoing parallel/sequential treatment cohorts means that the overall size and duration of the trial can be modified/prolonged based on accumulation of new data. The early success of the current trial suggests that the design may provide definitive leads in a patient-friendly and relatively economical trial structure. Along with other biomarker-driven trials that are currently underway, it is hoped that MODUL will contribute to the continuing evolution of clinical trial design and permit a more 'tailored' approach to the treatment of patients with mCRC.

A Faculty Development Program can result in an improvement of the quality and output in medical education, basic sciences and clinical research and patient care.

PubMed

Dieter, Peter Erich

2009-07-01

The Carl Gustav Carus Faculty of Medicine, University of Technology Dresden, Germany, was founded in 1993 after the reunification of Germany. In 1999, a reform process of medical education was started together with Harvard Medical International.The traditional teacher- and discipline-centred curriculum was displaced by a student-centred, interdisciplinary and integrative curriculum, which has been named Dresden Integrative Patient/Problem-Oriented Learning (DIPOL). The reform process was accompanied and supported by a parallel-ongoing Faculty Development Program. In 2004, a Quality Management Program in medical education was implemented, and in 2005 medical education received DIN EN ISO 9001:2000 certification. Quality Management Program and DIN EN ISO 9001:2000 certification were/are unique for the 34 medical schools in Germany.The students play a very important strategic role in all processes. They are members in all committees like the Faculty Board, the Board of Study Affairs (with equal representation) and the ongoing audits in the Quality Management Program. The Faculty Development program, including a reform in medical education, the establishment of the Quality Management program and the certification, resulted in an improvement of the quality and output of medical education and was accompanied in an improvement of the quality and output of basic sciences and clinical research and interdisciplinary patient care.

Premature progesterone rise on day of hCG negatively correlated with live birth rate in IVF cycles: An analysis of 1022 cycles.

PubMed

Lepage, Julien; Keromnes, Gwenola; Epelboin, Sylvie; Luton, Dominique; Yazbeck, Chadi

2018-05-18

To investigate the relationship between serum P levels on the day of hCG administration and pregnancy outcomes in patients undergoing IVF. Retrospective study. Teaching hospital. A total of 1022 IVF-ICSI cycles, frozen embryo transfer excluded. Patients-all types of responder - underwent IVF with agonist or antagonist protocols. Clinical outcomes of IVF were analyzed according to plasma P levels. Ongoing pregnancy rates. We proposed a serum P level of 1.57ng/ml on day of hCG as a threshold for all types of responders and all protocols combined. Ongoing implantation rates were not affected by elevated progesterone. Live birth rate was inversely associated with serum P levels on day of hCG and more miscarriages were associated with P>1.57ng/ml. We have not found the progesterone>1.57ng/ml on the day of hCG as a prognostic factor for pregnancy. Elevated P level on the day of hCG administration negatively influence live birth rate and is correlated to an increase of miscarriage. The detrimental effect of P elevation on pregnancy seems not to be related substantially to endometrium receptivity. Thus, despite a comparable clinical pregnancy rate and an initial implantation rate, we demonstrate more spontaneous abortion and it would seem that the effect of progesterone is later. Copyright © 2018. Published by Elsevier Masson SAS.

Patients' needs following colorectal cancer diagnosis: where does primary care fit in?

PubMed

Browne, Susan; Dowie, Al; Mitchell, Elizabeth; Mitchell, Liz; Wyke, Sally; Ziebland, Sue; Campbell, Neil; Macleod, Una

2011-11-01

Colorectal cancer is the third most common cancer in the UK. Patients with colorectal cancer spend most of their time in the community, but the role of primary care in their management and follow-up is unclear. To explore colorectal cancer patients' experiences of psychosocial problems and their management in primary and specialist care. Longitudinal qualitative study of participants recruited from three hospitals in the west of Scotland and interviewed in their own homes. In-depth interviews with 24 participants with a new diagnosis of colorectal cancer, and then follow-up interviews 12 months later. Participants' needs following a diagnosis for colorectal cancer included physical, psychological, and social issues. GPs played a key role in diagnosis, after which they were less involved. Participants valued GPs making unsolicited contact and offering support. Participants described being well supported by clinical nurse specialists who are expert in the illness, and who provide continuity of care and psychological support. A year after diagnosis, when there was less contact with GPs and clinical nurse specialists, participants still faced challenges associated with the ongoing impact of colorectal cancer. While some patients enjoyed straightforward recoveries from surgery, others experienced longer-term implications from their disease and treatment, particularly bowel-function issues, fatigue, anxiety, and sexual problems. The potential for primary care to contribute more to the ongoing care of colorectal cancer patients was identified.

Report of the American Heart Association (AHA) Scientific Sessions 2012, Los Angeles.

PubMed

Fujita, Jun

2013-01-01

The American Heart Association (AHA) Scientific Sessions were held for the first time in Los Angeles in 2012, with the most up-to-date basic and clinical science in the field presented and heard by physicians, research scientists, students, and paramedical personnel from 100 countries. Japan accounted for the second highest number of submitted abstracts and the Japanese Circulation Society actively contributed to the success of the AHA Scientific Sessions this year. The Late-Breaking Clinical Trial sessions comprised 27 clinical studies presented in the main hall. The FREEDOM study revealed the superiority of using a coronary artery bypass graft for diabetic multivessel coronary artery diseases over percutaneous coronary intervention using a drug-eluting stent. A new peptide hormone, serelaxin, improved dyspnea in heart failure patients and significantly reduced mortality rates according to the RELAX-AHF study. In the basic sciences, primary necrosis in mitochondria was the hot topic, while genetics, including genome-wide association studies, and epigenetics were strong features of the basic and clinical cardiovascular (CV) science. It was also clear that regenerative medicine is now part of mainstream CV research, with several clinical trials underway and many basic research projects ongoing around the world. Induced pluripotent stem cells in particular have the potential to change CV medicine, and will underpin the next era of regenerative medicine and personal therapies for heart diseases.

Idiopathic Pulmonary Fibrosis: Diagnosis and Clinical Manifestations

PubMed Central

Nakamura, Yutaro; Suda, Takafumi

2015-01-01

Idiopathic pulmonary fibrosis (IPF) is a parenchymal lung disease characterized by progressive interstitial fibrosis. The clinical course of IPF can be unpredictable and may be punctuated by acute exacerbations. Although much progress is being made in unraveling the mechanisms underlying IPF, effective therapy for improving survival remains elusive. Longitudinal disease profiling, especially in terms of clinical manifestations in a large cohort of patients, should lead to proper management of the patients and development of new treatments for IPF. Appropriate multidisciplinary assessment in ongoing registries is required to achieve this. This review summarizes the current status of the diagnosis and clinical manifestations of IPF. PMID:27625576

Properties and Units in the Clinical Laboratory Sciences. IX. Properties and Units in Trace Elements (IUPAC-IFCC Technical report 1997). International Union of Pure and Applied Chemistry and International Federation of Clinical Chemistry. rita.cornelis@rug.ac.be.

PubMed

Cornelis, R; Fuentes-Arderiu, X; Bruunshuus, I; Templeton, D

1997-12-10

This document is the first recommendation on the presentation of trace elements and their values in clinical laboratory sciences from IFCC and IUPAC. It forms part of the ongoing effort to standardize requests and reporting of laboratory data for transmission across cultural and linguistic domains, without attempting to standardize the language used by clinicians and laboratory practitioners. Subsequent documents deal with syntax, kinds-of-property, and properties and units used in other areas of clinical laboratory sciences.

Practice-centred evaluation and the privileging of care in health information technology evaluation.

PubMed

Darking, Mary; Anson, Rachel; Bravo, Ferdinand; Davis, Julie; Flowers, Steve; Gillingham, Emma; Goldberg, Lawrence; Helliwell, Paul; Henwood, Flis; Hudson, Claire; Latimer, Simon; Lowes, Paul; Stirling, Ian

2014-06-05

Our contribution, drawn from our experience of the case study provided, is a protocol for practice-centred, participative evaluation of technology in the clinical setting that privileges care. In this context 'practice-centred' evaluation acts as a scalable, coordinating framework for evaluation that recognises health information technology supported care as an achievement that is contingent and ongoing. We argue that if complex programmes of technology-enabled service innovation are understood in terms of their contribution to patient care and supported by participative, capability-building evaluation methodologies, conditions are created for practitioners and patients to realise the potential of technologies and make substantive contributions to the evidence base underpinning health innovation programmes. Electronic Patient Records (EPRs) and telemedicine are positioned by policymakers as health information technologies that are integral to achieving improved clinical outcomes and efficiency savings. However, evaluating the extent to which these aims are met poses distinct evaluation challenges, particularly where clinical and cost outcomes form the sole focus of evaluation design. We propose that a practice-centred approach to evaluation - in which those whose day-to-day care practice is altered (or not) by the introduction of new technologies are placed at the centre of evaluation efforts - can complement and in some instances offer advantages over, outcome-centric evaluation models. We carried out a regional programme of innovation in renal services where a participative approach was taken to the introduction of new technologies, including: a regional EPR system and a system to support video clinics. An 'action learning' approach was taken to procurement, pre-implementation planning, implementation, ongoing development and evaluation. Participants included clinicians, technology specialists, patients and external academic researchers. Whilst undergoing these activities we asked: how can a practice-centred approach be embedded into evaluation of health information technologies? Organising EPR and telemedicine evaluation around predetermined outcome measures alone can be impractical given the complex and contingent nature of such projects. It also limits the extent to which unforeseen outcomes and new capabilities are recognised. Such evaluations often fail to improve understanding of 'when' and 'under what conditions' technology-enabled service improvements are realised, and crucially, how such innovation improves care. Our contribution, drawn from our experience of the case study provided, is a protocol for practice-centred, participative evaluation of technology in the clinical setting that privileges care. In this context 'practice-centred' evaluation acts as a scalable, coordinating framework for evaluation that recognises health information technology supported care as an achievement that is contingent and ongoing. We argue that if complex programmes of technology-enabled service innovation are understood in terms of their contribution to patient care and supported by participative, capability-building evaluation methodologies, conditions are created for practitioners and patients to realise the potential of technologies and make substantive contributions to the evidence base underpinning health innovation programmes.

Design and implementation of a mobile system for lung cancer patient follow-up in China and initial report of the ongoing patient registry

PubMed Central

Li, Ziming; Niu, Xiaomin; Wang, Jiemin; Chen, Yunqin; Guo, Zongming; Lu, Shun

2017-01-01

Introduction Management of lung cancer remains a challenge. Although clinical and biological patient data are crucial for cancer research, these data may be missing from registries and clinical trials. Biobanks provide a source of high-quality biological material for clinical research; however, linking these samples to the corresponding patient and clinical data is technically challenging. We describe the mobile Lung Cancer Care system (mLCCare), a novel tool which integrates biological and clinical patient data into a single resource. Methods mLCCare was developed as a mobile device application (app) and an internet website. Data storage is hosted on cloud servers, with the mobile app and website acting as a front-end to the system. mLCCare also facilitates communication with patients to remind them to take their medication and attend follow-up appointments. Results Between January 2014 and October 2015, 5,080 patients with lung cancer have been registered with mLCCare. Data validation ensures all the patient information is of consistently high-quality. Patient cohorts can be constructed via user-specified criteria and data exported for statistical analysis by authorized investigators and collaborators. mLCCare forms the basis of establishing an ongoing lung cancer registry and could form the basis of a high-quality multisite patient registry. Integration of mLCCare with SMS messaging and WeChat functionality facilitates communication between physicians and patients. Conclusion It is hoped that mLCCare will prove to be a powerful and widely used tool that will enhance both research and clinical practice. PMID:27911868

Design and implementation of a mobile system for lung cancer patient follow-up in China and initial report of the ongoing patient registry.

PubMed

Ye, Xiangyun; Wei, Jia; Li, Ziming; Niu, Xiaomin; Wang, Jiemin; Chen, Yunqin; Guo, Zongming; Lu, Shun

2017-01-17

Management of lung cancer remains a challenge. Although clinical and biological patient data are crucial for cancer research, these data may be missing from registries and clinical trials. Biobanks provide a source of high-quality biological material for clinical research; however, linking these samples to the corresponding patient and clinical data is technically challenging. We describe the mobile Lung Cancer Care system (mLCCare), a novel tool which integrates biological and clinical patient data into a single resource. mLCCare was developed as a mobile device application (app) and an internet website. Data storage is hosted on cloud servers, with the mobile app and website acting as a front-end to the system. mLCCare also facilitates communication with patients to remind them to take their medication and attend follow-up appointments. Between January 2014 and October 2015, 5,080 patients with lung cancer have been registered with mLCCare. Data validation ensures all the patient information is of consistently high-quality. Patient cohorts can be constructed via user-specified criteria and data exported for statistical analysis by authorized investigators and collaborators. mLCCare forms the basis of establishing an ongoing lung cancer registry and could form the basis of a high-quality multisite patient registry. Integration of mLCCare with SMS messaging and WeChat functionality facilitates communication between physicians and patients. It is hoped that mLCCare will prove to be a powerful and widely used tool that will enhance both research and clinical practice.

The Mayo Clinic Biobank: A building block for individualized medicine

PubMed Central

Olson, Janet E.; Ryu, Euijung; Johnson, Kiley J.; Koenig, Barbara A.; Maschke, Karen J.; Morrisette, Jody A.; Liebow, Mark; Takahashi, Paul Y.; Fredericksen, Zachary S.; Sharma, Ruchi G.; Anderson, Kari S.; Hathcock, Matthew A.; Carnahan, Jason A.; Pathak, Jyotishman; Lindor, Noralane M.; Beebe, Timothy J.; Thibodeau, Stephen N.; Cerhan, James R.

2014-01-01

OBJECTIVE To report the design and first three years of enrollment of the Mayo Clinic Biobank. PATIENTS AND METHODS Preparations for this Biobank began with a 4-day Deliberative Community Engagement with local residents to obtain community input into the design and governance of the biobank. Recruitment, which began in April 2009, is ongoing with a target goal of 50,000. Any Mayo Clinic patient who is 18+ years, able to consent, and a US resident is eligible to participate. Each participant completes a health history questionnaire, provides a blood sample and allows access to existing tissue specimens and all data from their Mayo Clinic medical record (EMR). A Community Advisory Board provides ongoing advice and guidance on complex decisions. RESULTS After three years of recruitment, 21,736 subjects have enrolled. Participants were 58% female, 95% of European ancestry, and median age of 62 years. Seventy-four percent lived in Minnesota, 42% from Olmsted County where the Mayo Clinic Rochester is located. The five most commonly self-reported conditions were hyperlipidemia (41%), hypertension (38%), osteoarthritis (30%), any cancer (29%), and gastroesophageal reflux disease (26%). Among self-reported cancer patients, the five most common types were non-melanoma skin cancer (14%), prostate cancer (12% in men), breast cancer (4%), melanoma (3%), and cervical cancer (2% in women). Fifty-six percent of participants had at least 15 years of EMR history. To date, over sixty projects and over 69,000 samples have been approved for use. CONCLUSION The Mayo Clinic Biobank has quickly been established as a valuable resource for researchers. PMID:24001487

Development and feasibility of the misuse, abuse, and diversion drug event reporting system (MADDERS®).

PubMed

Treister, Roi; Trudeau, Jeremiah J; Van Inwegen, Richard; Jones, Judith K; Katz, Nathaniel P

2016-12-01

Inappropriate use of analgesic drugs has become increasingly pervasive over the past decade. Currently, drug abuse potential is primarily assessed post-marketing; no validated tools are available to assess this potential in phase II and III clinical trials. This paper describes the development and feasibility testing of a Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS), which aims to identify potentially abuse-related events and classify them according to a recently developed classification scheme, allowing the quantification of these events in clinical trials. The system was initially conceived and designed with input from experts and patients, followed by field-testing to assess its feasibility and content validity in both completed and ongoing clinical trials. The results suggest that MADDERS is a feasible system with initial validity. It showed higher rates of the triggering events in subjects taking medications with known abuse potential than in patients taking medications without abuse potential. Additionally, experts agreed on the classification of most abuse-related events in MADDERS. MADDERS is a new systematic approach to collect information on potentially abuse-related events in clinical trials and classify them. The system has demonstrated feasibility for implementation. Additional research is ongoing to further evaluate its validity. Currently, there are no validated tools to assess drug abuse potential during clinical trials. Because of its ease of implementation, its systematic approach, and its preliminary validation results, MADDERS could provide such a tool for clinical trials. (Am J Addict 2016;25:641-651). © 2016 American Academy of Addiction Psychiatry.

Improving clinical communication of students with English as a second language (ESL) using online technology: a small scale evaluation study.

PubMed

Rogan, Fran; San Miguel, Caroline

2013-09-01

Increasingly, students with English as a second language (ESL) are enrolled in nursing degrees in English speaking countries (Wang et al., 2008). However, they may be at risk of clinical practice failure due to communication difficulties associated with unfamiliar linguistic and cultural factors (Guhde, 2003). This paper describes and evaluates an innovation to assist ESL nursing students at an Australian university develop their clinical communication skills and practice readiness by providing online learning resources, using podcast and vodcast technology, that blend with classroom activities and facilitate flexible and independent learning. The innovation builds on an intensive clinical language workshop program called 'Clinically Speaking' which has evolved through a cyclical process of ongoing research to produce resources in response to students' learning needs. Whilst uptake of the resources was modest, students of ESL as well as English speaking backgrounds (ESB) found the resources improved their clinical preparation and confidence by increasing their understanding of expectations, clinical language and communication skills. The innovation, developed with a modest budget, shows potential in developing ESL and ESB students' readiness for clinical communication, enabling them to engage in clinical practice to develop competency standards required of nursing graduates and registration authorities. Copyright © 2012 Elsevier Ltd. All rights reserved.

Stakeholders' Perspectives on Preclinical Testing for Alzheimer's Disease.

PubMed

Arias, Jalayne J; Cummings, Jeffrey; Grant, Alexander Rae; Ford, Paul J

2015-01-01

Progress towards validating amyloid beta as an early indicator of Alzheimer's disease (AD) heightens the need for evaluation of stakeholders' perspectives of the benefits and harms of preclinical testing in asymptomatic individuals. Investigators conducted and analyzed 14 semi-structured interviews with family members of patients diagnosed with AD. Participants reported benefits, including the potential to seek treatment, make lifestyle changes, and prepare for cognitive impairment. Participants identified harms, including social harms, adverse life decisions, and psychological harms. Nine participants reported either a "positive global perspective" or a "positive global perspective (qualified)." Results from this study characterized stakeholders' perspectives on the potential benefits and harms of clinical use of preclinical testing for AD. Investigators used data from this study to develop a framework that contributes to ongoing discussions that will evaluate widespread adoption of preclinical testing and will inform future research. Copyright 2015 The Journal of Clinical Ethics. All rights reserved.

Ibogaine in the treatment of substance dependence.

PubMed

Brown, Thomas Kingsley

2013-03-01

Ibogaine is a psychoactive alkaloid derived from Tabernanthe iboga, a plant used in initiatory rituals in West Central Africa. Largely because of ibogaine's status as a Schedule I substance in the U.S., the development of ibogaine's use in the treatment of drug addiction took place outside conventional clinical and medical settings. This article reviews the history of ibogaine's use in the treatment of drug addiction, and discusses progress made towards, and obstacles blocking, the establishment of controlled clinical trials of ibogaine's efficacy. Preclinical research has generally supported anecdotal claims that ibogaine attenuates withdrawal symptoms and reduces drug cravings. Concerns about ibogaine's safety, as well as a dearth of solid data from human studies, have hampered progress in its development as an approved medication. This article outlines major findings from preclinical studies, discusses concerns about ibogaine's safety, and details previous and ongoing research on ibogaine's use as an anti-addictive treatment for humans.

Environmental Pollution Effects on Reproductive Health – Clinical-Epidemiological Study in Southern Italy

PubMed Central

Marra, M.L.; Zullo, F.; De Felice, B.; Nappi, L.; Guida, M.; Trifuoggi, M.; Nappi, C.; Di Spiezio Sardo, A.; Zizolfi, B.; Capece, G.; Visconti, F.; Troisi, J.; Ciccone, C.; Guida, M.

2012-01-01

This study aims to address the clinical, statistical and Epidemiological Relationship Between Birth Defects and Environmental Pollution, in the Campania Region and in Salerno. Objectives: We examined four groups of subjects as follows: a sample of pregnant women living in Salerno, a sample of pregnant women living in highly polluted areas, a sample of controls, pregnant women and residents out of the Campania Region, considered in unpolluted areas (Foggia) and in the Salerno area. Methodologies: a toxicological and genetic analysis was conducted on patients examined. Conclusions: there is an epidemiological link between environmental pollution and reproductive health in the Salerno area. Experimentally there are the first evidences of endocrine disruptors by the PCB. It has been inferred an overexpression of the mir-191 as a marker of pollution by dioxin-like compounds. Socially, correct information of populations at risk is necessary and a possible preventive and ongoing medical care must be ensured. PMID:23905062

Space Flight-Associated Neuro-ocular Syndrome.

PubMed

Lee, Andrew G; Mader, Thomas H; Gibson, C Robert; Tarver, William

2017-09-01

New and unique physiologic and pathologic systemic and neuro-ocular responses have been documented in astronauts during and after long-duration space flight. Although the precise cause remains unknown, space flight-associated neuro-ocular syndrome (SANS) has been adopted as an appropriate descriptive term. The Space Medicine Operations Division of the US National Aeronautics and Space Administration (NASA) has documented the variable occurrence of SANS in astronauts returning from long-duration space flight on the International Space Station. These clinical findings have included unilateral and bilateral optic disc edema, globe flattening, choroidal and retinal folds, hyperopic refractive error shifts, and nerve fiber layer infarcts. The clinical findings of SANS have been correlated with structural changes on intraorbital and intracranial magnetic resonance imaging and in-flight and terrestrial ultrasonographic studies and ocular optical coherence tomography. Further study of SANS is ongoing for consideration of future manned missions to space, including a return trip to the moon or Mars.

Safety and Clinical Usage of Newcastle Disease Virus in Cancer Therapy

PubMed Central

Lam, Han Yuen; Yeap, Swee Keong; Rasoli, Mehdi; Omar, Abdul Rahman; Yusoff, Khatijah; Suraini, Abd Aziz; Banu Alitheen, Noorjahan

2011-01-01

Newcastle disease virus (NDV) is an avian virus that causes deadly infection to over 250 species of birds, including domestic and wild-type, thus resulting in substantial losses to the poultry industry worldwide. Many reports have demonstrated the oncolytic effect of NDV towards human tumor cells. The interesting aspect of NDV is its ability to selectively replicate in cancer cells. Some of the studies have undergone human clinical trials, and favorable results were obtained. Therefore, NDV strains can be the potential therapeutic agent in cancer therapy. However, investigation on the therapeutic perspectives of NDV, especially human immunological effects, is still ongoing. This paper provides an overview of the current studies on the cytotoxic and anticancer effect of NDV via direct oncolysis effects or immune stimulation. Safety of NDV strains applied for cancer immunotherapy is also discussed in this paper. PMID:22131816

Intravenous immunoglobulin and idiopathic secondary recurrent miscarriage: a multicentered randomized placebo-controlled trial

PubMed Central

Stephenson, Mary D.; Kutteh, William H.; Purkiss, Susan; Librach, Cliff; Schultz, Patricia; Houlihan, Edwina; Liao, Chuanhong

2010-01-01

BACKGROUND Idiopathic secondary recurrent miscarriage may be associated with an abnormal maternal immune response to subsequent pregnancies. Intravenous immunoglobulin (IVIG) has been studied in randomized controlled trials (RCTs) with conflicting results. Therefore, a definitive trial was proposed. METHODS We conducted an investigator-initiated, multicentered, randomized, double-blinded, placebo-controlled trial comparing IVIG with saline in women with idiopathic secondary recurrent miscarriage, defined as a history of at least one prior ongoing pregnancy followed by three or more consecutive unexplained miscarriages. Subjects received either IVIG 500 mg/kg or the equivalent volume of normal saline. Preconception infusions were administered 14–21 days from the projected next menstrual period. With documentation of pregnancy, the subject received the same infusion every 4 weeks until 18–20 weeks of gestation. The primary outcome was an ongoing pregnancy of at least 20 weeks of gestation. RESULTS A total of 82 patients enrolled, of whom 47 had an index pregnancy. All ongoing pregnancies resulted in live births. Therefore, the live birth rates were 70% (16/23) in the IVIG group and 63% (15/24) in the control group (P = 0.760); odds ratio (OR) 1.37 [95% confidence interval (CI) 0.41–4.61]. Including only clinical pregnancies (embryo with cardiac activity at 6 weeks of gestation), the live birth rates were equivalent, 94% (16/17) and (15/16), respectively (P > 0.999); OR 1.07 (95% CI 0.06–18.62). Meta-analysis of randomized controlled trials (RCTs) evaluating IVIG for idiopathic secondary recurrent miscarriage revealed live birth rates of 70% (31/44) in the IVIG group and 62% (28/45) in the control group (P = 0.503); common OR 1.44 (95% CI 0.59–3.48). CONCLUSIONS This is the largest RCT to date in which IVIG was evaluated in women with idiopathic secondary recurrent miscarriage; no treatment benefit was found. The meta-analysis, which combined our study results with two prior RCTs, also showed no significant effect of treatment with IVIG. ClinicalTrials.gov NCT00606905. PMID:20634190

Corifollitropin alfa followed by highly purified HMG versus recombinant FSH in young poor ovarian responders: a multicentre randomized controlled clinical trial.

PubMed

Drakopoulos, Panagiotis; Vuong, Thi Ngoc Lan; Ho, Ngoc Anh Vu; Vaiarelli, Alberto; Ho, Manh Tuong; Blockeel, Christophe; Camus, Michel; Lam, Anh Tuan; van de Vijver, Arne; Humaidan, Peter; Tournaye, Herman; Polyzos, Nikolaos P

2017-11-01

Does administration of corifollitropin alfa followed by highly purified (hp) HMG result in higher ongoing pregnancy rates compared with daily recombinant FSH (rFSH) in young poor responders? Corifollitropin alfa followed by hp-HMG does not increase ongoing pregnancy rates compared with rFSH in young poor responders, although more supernumerary cryopreserved embryos were obtained with corifollitropin alfa and hp-HMG. Poor ovarian response remains one of the main therapeutic challenges in women undergoing ovarian stimulation, given that very low live birth rates of 6% have been reported in this particular group of infertile patients. Nevertheless, concerns have been raised that a degree of heterogeneity remains, as the prognostic effect of individual factors is still unclear, particularly for the young poor responder group. The rationale for conducting the current randomized trial was based on the results of a previous pilot study demonstrating promising results with the administration of hp-HMG following corifollitropin alpha in women younger than 40 years of age, fulfilling the 'Bologna' criteria. A multicenter, phase III, superiority, randomized trial was conducted using a parallel two-arm design. The study included 152 patients younger than 40 years old and fulfilling the 'Bologna' criteria for poor ovarian response, from one tertiary referral centre in Europe and one tertiary referral centre in Asia. Enrolment was performed from March 2013 to May 2016. Eligible patients were randomized to either administration of 150 μg corifollitropin alfa followed by 300 IU hp-HMG (Group A) or to 300 IU of daily recombinant FSH (Group B) in a fixed GnRH antagonist protocol. The randomization sequence was created using a computer generated randomization list stratified by centre, using 1:1 allocation. The primary outcome was ongoing pregnancy rate (defined as the presence of an intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 9-10 weeks of gestation). Secondary outcomes included embryo cryopreservation rates, clinical and biochemical pregnancy rates and number of oocytes retrieved. Overall, 152 poor ovarian responders defined by the 'Bologna' criteria were included in the study. Using an intention-to treat analysis, the ongoing pregnancy rates did not differ significantly between Group A 11/77 (14.3%) and Group B 11/70 (15.7%), absolute difference: -0.4 (-11.5 to 10.8), OR = 0.9 (0.4-2.4). Biochemical and clinical pregnancy rates, live birth rates and the number of oocytes retrieved were also comparable between the two groups. Nevertheless, more patients in the corifollitropin alfa group had cryopreserved embryos compared to the rFSH group [22 (28.6%) versus 10 (14.3%), OR = 2.4 (1.01-5.5)]. Incidentally, Asian patients had significantly lower cancellation rates compared to European poor responders [2/64 (3.1%) versus 17/83 (20.4%), OR = 0.12 (0.03-0.5)]. This discrepancy could be explained by the fact that Asian women were better prognosis patients than European patients, with significantly lower FSH [9.8 (5.3) versus 11.5 (5.4), P = 0.017] and significantly higher AMH [1.1 (0.9) versus 0.4 (0.3), P-value <0.001] levels. Ongoing pregnancy rates close to 14% for both treatment groups differ significantly from the hypothesized primary outcome rates used in the power calculation. Therefore, our randomized trial might have been underpowered to detect smaller differences. The use of multiple secondary outcomes and multiple comparisons could have increased a Type 1 error. Finally, although the chance of selection biases remains low given the nature of the infertile population, the open-label design could have been a limitation. Poor ovarian response represents a challenge and although a specific protocol may have increased the number of cryopreserved embryos, no difference was observed in ongoing pregnancy rates. Our study, being one of the largest RCTs in 'Bologna' criteria poor responders, highlights that baseline characteristics may play a crucial role in clinical prognosis of this population. Given that ovarian stimulation using novel protocols does not seem to significantly increase pregnancy rates even in young women, we suggest that future clinical research should focus on increasing the number of recruitable follicles and on oocyte quality rather than evaluating different stimulation protocols. No external funding was used for this study. P.D., N.L.V., N.A.V.H., A.V., M.T.H., M.C., A.T.L. and A.V.V. have no conflict of interest to report. C.B. has received unrestricted research grants from MSD and Ferring as well as honoraria for lectures from Abbott, MSD, Merck and Ferring. P.H has received unrestricted research grants from MSD, Merck and Ferring as well as honoraria for lectures from Merck, MSD and IBSA. H.T. has received unrestricted research grants from MSD, Merck, Ferring, Cook, Roche Diagnostics, Besins International and Goodlife as well as consultation fees for research project in female infertility from Merck Finox, Abbott and ObsEva. N.P.P. has received unrestricted research grants from MSD, Ferring, Roche Diagnostics and Besins International as well as honoraria for lectures from MSD, Merck and Ferring. The EUDRACT number of the trial was 2013-000583-29 and the study was registered at clinicaltrials.gov (NCT01816321). 19 February 2013. 28 February 2013. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com

Towards Clinical Applications of Anti-endotoxin Antibodies; A Re-appraisal of the Disconnect

PubMed Central

Hurley, James C.

2013-01-01

Endotoxin is a potent mediator of a broad range of patho-physiological effects in humans. It is present in all Gram negative (GN) bacteria. It would be expected that anti-endotoxin therapies, whether antibody based or not, would have an important adjuvant therapeutic role along with antibiotics and other supportive therapies for GN infections. Indeed there is an extensive literature relating to both pre-clinical and clinical studies of anti-endotoxin antibodies. However, the extent of disconnect between the generally successful pre-clinical studies versus the failures of the numerous large clinical trials of antibody based and other anti-endotoxin therapies is under-appreciated and unexplained. Seeking a reconciliation of this disconnect is not an abstract academic question as clinical trials of interventions to reduce levels of endotoxemia levels are ongoing. The aim of this review is to examine new insights into the complex relationship between endotoxemia and sepsis in an attempt to bridge this disconnect. Several new factors to consider in this reappraisal include the frequency and types of GN bacteremia and the underlying mortality risk in the various study populations. For a range of reasons, endotoxemia can no longer be considered as a single entity. There are old clinical trials which warrant a re-appraisal in light of these recent advances in the understanding of the structure-function relationship of endotoxin. Fundamentally however, the disconnect not only remains, it has enlarged. PMID:24351718

Luminescent magnetic quantum dots for in vitro/in vivo imaging and applications in therapeutics.

PubMed

Acharya, Amitabha

2013-06-01

The quest for design of newer/advanced methods for medical diagnosis and targeted therapeutics are of utmost interest and challenging too, because of its importance in clinical diagnosis. Currently available diagnosis methodologies have their own disadvantages. These shortcomings can be overcome by using multimodal imaging systems where two or more imaging modalities may be coupled. Nanoparticles being widely studied for targeted drug delivery and as biological contrasting agents, might play a decisive role in such findings. This review is focused towards the ongoing research in the area of hybrid nanocomposites which can be used for both as MRI contrasting agent (magnetic nanoparticles) and molecular imaging studies (using fluorescent quantum dots) at in vitro and in vivo level. Though several reports are available in literature for such bimodal imaging systems, their clinical trials are very restricted, possibly because of the lack of communication between the in vitro and in vivo studies. This review is expected to bridge the gap between such studies.

Lymphogranuloma venereum variant L2b-specific polymerase chain reaction: insertion used to close an epidemiological gap.

PubMed

Verweij, S P; Catsburg, A; Ouburg, S; Lombardi, A; Heijmans, R; Dutly, F; Frei, R; Morré, S A; Goldenberger, D

2011-11-01

The management of the ongoing lymphogranuloma venereum epidemic in industrialized Western countries caused by Chlamydia trachomatis variant L2b still needs improvements in diagnosis, therapy and prevention. We therefore developed the first rapid C. trachomatis variant L2b-specific polymerase chain reaction to circumvent laborious ompA gene sequencing. © 2011 The Authors. Clinical Microbiology and Infection © 2011 European Society of Clinical Microbiology and Infectious Diseases.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bookman, M.A.; Bast, R.C. Jr.

Small volume residual peritoneal disease in patients undergoing therapy for ovarian carcinoma remains an attractive, but elusive, target for immunobiological therapy. Hypothetical advantages and disadvantages of regional peritoneal therapy are being better defined through increased clinical experience and more sophisticated animal models. Developments in cytokine biology, adoptive cellular therapy, monoclonal antibody conjugation, and molecular biology continue to provide an exciting, and nearly overwhelming, array of reagents for clinical evaluation. Ongoing and anticipated investigational trials should provide intriguing data in years to follow.198 references.

Imaging Depression in Adults with ASD

DTIC Science & Technology

2017-10-01

collected temporally close enough to imaging data in Phase 2 to be confidently incorporated in the planned statistical analyses, and (b) not unduly risk...Phase 2 to be confidently incorporated in the planned statistical analyses, and (b) not unduly risk attrition between Phase 1 and 2, we chose to hold...supervision is ongoing (since 9/2014). • Co-l Dr. Lerner’s 2nd year Clinical Psychology PhD students have participated in ADOS- 2 Introductory Clinical

Maximizing Team Performance: The Critical Role of the Nurse Leader.

PubMed

Manges, Kirstin; Scott-Cawiezell, Jill; Ward, Marcia M

2017-01-01

Facilitating team development is challenging, yet critical for ongoing improvement across healthcare settings. The purpose of this exemplary case study is to examine the role of nurse leaders in facilitating the development of a high-performing Change Team in implementing a patient safety initiative (TeamSTEPPs) using the Tuckman Model of Group Development as a guiding framework. The case study is the synthesis of 2.5 years of critical access hospital key informant interviews (n = 50). Critical juncture points related to team development and key nurse leader actions are analyzed, suggesting that nurse leaders are essential to maximize clinical teams' performance. © 2016 Wiley Periodicals, Inc.

Impact of chronobiology on neuropathic pain treatment.

PubMed

Gilron, Ian

2016-01-01

Inflammatory pain exhibits circadian rhythmicity. Recently, a distinct diurnal pattern has been described for peripheral neuropathic conditions. This diurnal variation has several implications: advancing understanding of chronobiology may facilitate identification of new and improved treatments; developing pain-contingent strategies that maximize treatment at times of the day associated with highest pain intensity may provide optimal pain relief as well as minimize treatment-related adverse effects (e.g., daytime cognitive dysfunction); and consideration of the impact of chronobiology on pain measurement may lead to improvements in analgesic study design that will maximize assay sensitivity of clinical trials. Recent and ongoing chronobiology studies are thus expected to advance knowledge and treatment of neuropathic pain.

Near-infrared optical guided surgery of highly infiltrative fibrosarcomas in cats using an anti-αvß3 integrin molecular probe.

PubMed

Wenk, Christiane H F; Ponce, Frédérique; Guillermet, Stéphanie; Tenaud, Corinne; Boturyn, Didier; Dumy, Pascal; Watrelot-Virieux, Dorothée; Carozzo, Claude; Josserand, Véronique; Coll, Jean-Luc

2013-07-01

We investigated how near-infrared imaging could improve highly infiltrative spontaneous fibrosarcoma surgery in 12 cats in a clinical veterinary phase. We used an RGD-based nanoprobe at different doses and times before surgery and a portable clinical grade imaging system. All tumours were labelled by the tracer and had an overall tumour-to-healthy tissue ratio of 14±1 during surgery. No false negatives were found, and the percentage of tumour cells was linearly correlated with the fluorescence intensity. All cats recovered well and were submitted to long-term follow-up that is currently on-going 1year after the beginning of the study. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Assessment of the pharmacodynamics of intranasal, intravenous and oral scopolamine

NASA Technical Reports Server (NTRS)

Tietze, Karen J.

1990-01-01

Space motion sickness is an important issue in the space medical sciences program. One of the objectives of the ongoing clinical experimental protocol Pharmacokinetics of Intranasal Scopolamine in Normal Subjects is to evaluate the pharmacodynamics of scopolamine using salivary flow rate and pH profiles and cognitive performance tests as pharmacodynamic parameters. Normal volunteers collected saliva and performed the NTI Multiresource Performance Battery tests at designed time intervals to establish control saliva flow rates, salivary pH profiles, and the characteristics of the learning curve for the performance program under normal conditions. In the clinical part of the study, saliva samples and performance test scores are collected from healthy nonsmoking subjects after receiving a single 0.4 mg dose of either intranasal, intravenous, or oral scopolamine.

Breast Cancer Screening, Mammography, and Other Modalities.

PubMed

Fiorica, James V

2016-12-01

This article is an overview of the modalities available for breast cancer screening. The modalities discussed include digital mammography, digital breast tomosynthesis, breast ultrasonography, magnetic resonance imaging, and clinical breast examination. There is a review of pertinent randomized controlled trials, studies and meta-analyses which contributed to the evolution of screening guidelines. Ultimately, 5 major medical organizations formulated the current screening guidelines in the United States. The lack of consensus in these guidelines represents an ongoing controversy about the optimal timing and method for breast cancer screening in women. For mammography screening, the Breast Imaging Reporting and Data System lexicon is explained which corresponds with recommended clinical management. The presentation and discussion of the data in this article are designed to help the clinician individualize breast cancer screening for each patient.

Clinical trials in mild traumatic brain injury.

PubMed

Hoffer, Michael E; Szczupak, Mikhaylo; Balaban, Carey

2016-10-15

Traumatic brain injury is an increasingly prevalent injury seen in both civilian and military populations. Regardless of the mechanisms of injury, the most common sub-type of injury continues to be mild traumatic brain injury. Within the last decade, there has been tremendous growth in the literature regarding this disease entity. To describe the obstacles necessary to overcome in performing a rigorous and sound clinical research study investigating mild traumatic brain injury. This examination begins by a consideration of changing standards for good faith open and total reporting of any and all conflicts of interest or commitment. This issue is particularly critical in mTBI research. We next examine obstacles that include but are not limited to diagnostic criteria, inclusion/exclusion criteria, source of injury, previous history of injury, presence of comorbid conditions and proper informed consent of participants. Frequently, multi-center studies are necessary for adequate subject accrual with the added challenges of site coordination, data core management and site specific study conduct. We propose a total reversal to the traditional translational research approach where clinical studies drive new concepts for future basic science studies. There have been few mild traumatic brain injury clinical trials in the literature with treatments/interventions that have been able to overcome many of these described obstacles. We look forward to the results of current and ongoing clinical mild traumatic brain injury studies providing the tools necessary for the next generation of basic science projects. Copyright © 2016 Elsevier B.V. All rights reserved.

Improving Outcomes for Pulmonary Vascular Disease

PubMed Central

Robbins, Ivan M.; Blaisdell, Carol J.; Abman, Steven H.

2012-01-01

Recognizing the importance of improving lung health through lung disease research, the National Heart, Lung, and Blood Institute (NHLBI) convened a workshop of multidisciplinary experts for the following purpose: (1) to review the current scientific knowledge underlying the basis for treatment of adults and children with pulmonary vascular diseases (PVDs); (2) to identify gaps, barriers, and emerging scientific opportunities in translational PVD research and the means to capitalize on these opportunities; (3) to prioritize new research directions that would be expected to affect the clinical course of PVDs; and (4) to make recommendations to the NHLBI on how to fill identified gaps in adult and pediatric PVD clinical research. Workshop participants reviewed experiences from previous PVD clinical trials and ongoing clinical research networks with other lung disorders, including acute respiratory distress syndrome, chronic obstructive lung disease, and idiopathic pulmonary fibrosis, as well. Bioinformatics experts discussed strategies for applying cutting-edge health information technology to clinical studies. Participants in the workshop considered approaches in the following broad concept areas: (1) improved phenotyping to identify potential subjects for appropriate PVD clinical studies; (2) identification of potential new end points for assessing key outcomes and developing better-designed PVD clinical trials; and (3) the establishment of priorities for specific clinical research needed to advance care of patients with various subsets of PVDs from childhood through adulthood. This report provides a summary of the objectives and recommendations to the NHLBI concentrating on clinical research efforts that are needed to better diagnose and treat PVDs. PMID:22335936

Using two on-going HIV studies to obtain clinical data from before, during and after pregnancy for HIV-positive women.

PubMed

Huntington, Susie E; Bansi, Loveleen K; Thorne, Claire; Anderson, Jane; Newell, Marie-Louise; Taylor, Graham P; Pillay, Deenan; Hill, Teresa; Tookey, Pat A; Sabin, Caroline A

2012-07-28

The UK Collaborative HIV Cohort (UK CHIC) is an observational study that collates data on HIV-positive adults accessing HIV clinical care at (currently) 13 large clinics in the UK but does not collect pregnancy specific data. The National Study of HIV in Pregnancy and Childhood (NSHPC) collates data on HIV-positive women receiving antenatal care from every maternity unit in the UK and Ireland. Both studies collate pseudonymised data and neither dataset contains unique patient identifiers. A methodology was developed to find and match records for women reported to both studies thereby obtaining clinical and treatment data on pregnant HIV-positive women not available from either dataset alone. Women in UK CHIC receiving HIV-clinical care in 1996-2009, were found in the NSHPC dataset by initially 'linking' records with identical date-of-birth, linked records were then accepted as a genuine 'match', if they had further matching fields including CD4 test date. In total, 2063 women were found in both datasets, representing 23.1% of HIV-positive women with a pregnancy in the UK (n = 8932). Clinical data was available in UK CHIC following most pregnancies (92.0%, 2471/2685 pregnancies starting before 2009). There was bias towards matching women with repeat pregnancies (35.9% (741/2063) of women found in both datasets had a repeat pregnancy compared to 21.9% (1502/6869) of women in NSHPC only) and matching women HIV diagnosed before their first reported pregnancy (54.8% (1131/2063) compared to 47.7% (3278/6869), respectively). Through the use of demographic data and clinical dates, records from two independent studies were successfully matched, providing data not available from either study alone.

Impact of an Electronic Monitoring Intervention to Improve Adherence to Inhaled Medication in Patients with Asthma and Chronic Obstructive Pulmonary Disease: Study Protocol for a Randomized Controlled Trial

PubMed Central

Dieterle, Thomas; Dürr, Selina; Arnet, Isabelle; Hersberger, Kurt E; Leuppi, Jörg D

2017-01-01

Background Despite progress in pharmacological and non-pharmacological treatment in recent years, the burden of disease among patients with asthma and chronic obstructive pulmonary disease (COPD) is high and patients are frequently hospitalized due to exacerbations. Reasons for uncontrolled diseases are manifold, but are often associated with poor inhalation technique and non-adherence to the prescribed treatment plan. This causes substantial mortality, morbidity, and costs to the healthcare system. In this respect, the study of causes for non-adherence and the development of measures to increase and maintain treatment adherence in chronic diseases is of major clinical importance. Objective The primary objective of this study is to investigate the impact of using specific, validated electronic devices on adherence to inhaled medication in patients with chronic obstructive lung diseases such as asthma and COPD. Furthermore, it aims to assess the impact of a reminder and close supervision of the course of disease and quality of life. Methods In this ongoing prospective, single-blind, randomized controlled study, adherence to inhaled medication is analyzed over a 6-month period in at least 154 in- and outpatients with asthma or COPD who have experienced at least 1 exacerbation during the last year. Adherence is measured using electronic data capture devices, which save the date and time of each inhalative device actuation and transfer these data daily via a wireless connection to a Web-based database. Patients are randomly assigned to either the intervention or the control group. The clinical intervention consists of an automated and personal reminder. The intervention group receives an audio reminder and support calls in case medication has not been taken as prescribed or if rescue medication is used more frequently than pre-specified in the study protocol. During the study, participants are assessed every 2 months in the form of clinical visits. Results Recruitment started in January 2014. To date, a total of 169 patients have been recruited. Follow-up assessments are still ongoing. The study will be concluded in the first quarter of 2017. Data analysis will take place during 2017. Conclusions Few studies have investigated medication adherence in patients with chronic obstructive lung diseases. With this prospective study design and the use of state-of-the-art devices for measuring adherence, we expect scientifically relevant and clinically meaningful results that will have a substantial and positive impact on the provision of healthcare in chronically ill patients suffering from asthma or COPD. Trial Registration ClinicalTrials.gov: NCT02386722; https://clinicaltrials.gov/ct2/show/NCT02386722 (Archived by WebCite at http://www.webcitation.org/6oJq1fel0) PMID:29061556

Biological Treatment Approaches for Degenerative Disk Disease: A Literature Review of In Vivo Animal and Clinical Data

PubMed Central

Moriguchi, Yu; Alimi, Marjan; Khair, Thamina; Manolarakis, George; Berlin, Connor; Bonassar, Lawrence J.; Härtl, Roger

2016-01-01

Study Design  Literature review. Objective  Degenerative disk disease (DDD) has a negative impact on quality of life and is a major cause of morbidity worldwide. There has been a growing interest in the biological repair of DDD by both researchers and clinicians alike. To generate an overview of the recent progress in reparative strategies for the treatment of DDD highlighting their promises and limitations, a comprehensive review of the current literature was performed elucidating data from in vivo animal and clinical studies. Methods  Articles and abstracts available in electronic databases of PubMed, Web of Science, and Google Scholar as of December 2014 were reviewed. Additionally, data from unpublished, ongoing clinical trials was retrieved from clinicaltrials.gov and available abstracts from research forums. Data was extracted from the most recent in vivo animal or clinical studies involving any of the following: (1) treatment with biomolecules, cells, or tissue-engineered constructs and (2) annulus fibrosus repair. Results  Seventy-five articles met the inclusion criteria for review. Among these, 17 studies involved humans; 37, small quadrupeds; and 21, large quadrupeds. Findings from all treatments employed demonstrated improvement either in regenerative capacity or in pain attenuation, with the exception of one clinical study. Conclusion  Published clinical studies on cell therapy have reported encouraging results in the treatment of DDD and resultant back pain. We expect new data to emerge in the near future as treatments for DDD continue to evolve in parallel to our greater understanding of disk health and pathology. PMID:27433434

The Breathmobile Program: structure, implementation, and evolution of a large-scale, urban, pediatric asthma disease management program.

PubMed

Jones, Craig A; Clement, Loran T; Hanley-Lopez, Jean; Morphew, Tricia; Kwong, Kenny Yat Choi; Lifson, Francene; Opas, Lawrence; Guterman, Jeffrey J

2005-08-01

Despite more than a decade of education and research-oriented intervention programs, inner city children with asthma continue to engage in episodic "rescue" patterns of healthcare and experience a disproportionate level of morbidity. The aim of this study was to establish and evaluate a sustainable community-wide pediatric asthma disease management program designed to shift inner city children in Los Angeles from acute episodic care to regular preventive care in accordance with national standards. In 1995 the Southern California Chapter of the Asthma and Allergy Foundation of America (AAFA), the Los Angeles County Department of Health Services (LAC DHS), and the Los Angeles Unified School District (LAUSD) established an agreement to initiate and sustain the Breathmobile Program. This program includes automated case identification, mobile school-based clinics, and highly structured clinical encounters supported by an advanced information technology solution. Interdisciplinary teams of asthma care specialists provide regular and ongoing care to children at school and county clinic sites over a wide geographic area of urban Los Angeles. Each team operates in a specially equipped mobile clinic (Breathmobile), efficiently moving a structured healthcare process to school and county clinic sites with large numbers of children. Demographic, clinical, and participation data is tracked carefully in an electronic medical record system. Program operations, clinical oversight, and patient tracking are centralized at a care coordination center. Clinical operations and methods have been replicated in fixed specialty clinic sites at the Los Angeles County + University of Southern California Medical Center. Clinical and process measures are regularly evaluated to assure quality, plan iterative improvement, and support evidence-based care. Four Breathmobiles deliver ongoing care at more than 90 school sites. The program has engaged over five thousand patients and their families in a continuity care model that has demonstrated efficacy over usual episodic care. More than 90% of patients in all asthma severity categories achieved clinical control of asthma with significant reductions in inpatient (IP) and emergency department (ED) use. On February 14, 2002, the program became the first program in the United States to receive the award of disease-specific care certification by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Proper design and resource allocation can sustain a school-based community-wide pediatric asthma disease management program and shift a population of inner city children from acute episodic care to routine preventive care in accordance with national standards. An evidence-based approach to evaluating and maintaining quality, coupled with stratified care delivery, can assure the efficient use of safety net healthcare resources.

The rapid expansion of (mainstream) health psychology in France: Historical foundations.

PubMed

Santiago-Delefosse, Marie; Del Rio Carral, Maria

2018-03-01

This article traces the historical evolution of ongoing theoretical debates in psychology in France from the 1940s until today. Its aim is to show how the conjunction of certain conditions led to a rapid expansion of American-derived mainstream health psychology during the 1980s. The authors describe the French context in the post-World War II period and outline the implementation of 'clinical psychology in health settings' in the 1950s, under the influence of Daniel Lagache. The strong critiques of the new psychology profession in the 1950s, 1960s and 1970s are examined. Our conclusion reflects upon future implications of ongoing rivalries between different approaches to psychology.

Struggles, strengths, and strategies: an ethnographic study exploring the experiences of adolescents living with an ostomy

PubMed Central

Nicholas, David B; Swan, Sylvia R; Gerstle, Ted J; Allan, Theresa; Griffiths, Anne Marie

2008-01-01

Background Adolescents with IBD requiring ostomy surgery experience perioperative needs that may exceed those of patients experiencing other major abdominal surgery [1]. This procedure requires ongoing and vigilant daily care and management. Gastrointestinal symptoms and complications impose psychological and social stresses on young patients [2], and the procedure results in body image changes and daily regimens of self-care. This study aimed to explore adolescents' experiences and quality of life following ostomy surgery. Methods Ethnographic interviews and a subsequent focus group were conducted with 20 adolescents with an ostomy or j-pouch being treated at the Hospital for Sick Children in Toronto, Canada. Interviews were transcribed verbatim and subjected to theme generation. Results Findings suggest that adolescents are profoundly affected by their ostomy. Adolescents convey strength as well as adjustment struggles. Identified impacts include body intrusion and body image changes, decreased independence, secrecy about the ostomy, adjustment over time, challenges for the family, and strategies for constructively moving forward. Conclusion Implications address the importance of ensuring meaningful opportunities to understand and reframe the stresses of illness. An ongoing clinical challenge involves the promotion of a healthy self-esteem and psychosocial adjustment for these adolescents and their families. Finding effective ways to minimize stress and embarrassment and reframe personal shame, constitute important clinical priorities. Opportunities for peer support and family dialogue may assist in clarifying worries and easing the burden carried by these young persons. Flexible and adequately funded resources are advocated in fostering quality of life. PMID:19091104

Aliskiren: review of efficacy and safety data with focus on past and recent clinical trials.

PubMed

Sen, Selçuk; Sabırlı, Soner; Ozyiğit, Tolga; Uresin, Yağız

2013-09-01

Aliskiren is the newest antihypertensive drug and the first orally active direct renin inhibitor to become available for clinical use. Clinical data have substantiated that the antihypertensive effectiveness of aliskiren is similar to that of the other major antihypertensive agents. Furthermore, aliskiren has a similar safety profile to placebo. Combination treatment with aliskiren showed significant blood pressure and proteinuria reductions compared with monotherapy. Aliskiren decreases plasma renin activity in contrast to other renin-angiotensin-aldosterone related drugs. The efficacy of aliskiren in treating major cardiovascular events and the prevention of end-organ damage are being investigated in the ASPIRE HIGHER program. Although the first studies of the ASPIRE HIGHER program such as ALOFT, AVOID, AGELESS showed favorable findings, ASPIRE and AVANT-GARDE studies provided contradictory results. Subsequently, the ALTITUDE study was terminated early because of safety issues and lack of beneficial effects. Most recently, the ASTRONAUT trial showed no reduction in cardiovascular death or heart failure rehospitalization with the addition of aliskiren to standard therapy in patients who were hospitalized for heart failure and with reduced left-ventricular ejection fraction. The results of ongoing studies in other patient groups such as the ATMOSPHERE trial are awaited.

Long acting systemic HIV pre-exposure prophylaxis: an examination of the field.

PubMed

Lykins, William R; Luecke, Ellen; Johengen, Daniel; van der Straten, Ariane; Desai, Tejal A

2017-12-01

Oral pre-exposure prophylaxis for the prevention of HIV-1 transmission (HIV PrEP) has been widely successful as demonstrated by a number of clinical trials. However, studies have also demonstrated the need for patients to tightly adhere to oral dosing regimens in order to maintain protective plasma and tissue concentrations. This is especially true for women, who experience less forgiveness from dose skipping than men in clinical trials of HIV PrEP. There is increasing interest in long-acting (LA), user-independent forms of HIV PrEP that could overcome this adherence challenge. These technologies have taken multiple forms including LA injectables and implantables. Phase III efficacy trials are ongoing for a LA injectable candidate for HIV PrEP. This review will focus on the design considerations for both LA injectable and implantable platforms for HIV PrEP. Additionally, we have summarized the existing LA technologies currently in clinical and pre-clinical studies for HIV PrEP as well as other technologies that have been applied to HIV PrEP and contraceptives. Our discussion will focus on the potential application of these technologies in low resource areas, and their use in global women's health.

The informal curriculum - general practitioner perceptions of ethics in clinical practice.

PubMed

Sturman, Nancy J; Parker, Malcolm; van Driel, Mieke L

2012-12-01

Australian medical students should graduate with an understanding of the principles of medical law and ethics, and their application to clinical settings. Although student perspectives have been studied previously, the teacher experience of ethical issues also needs to be understood, particularly in the general practice setting. Interviews were conducted with a convenience sample of 13 general practitioner teachers. They were asked to reflect on common and/or important ethical issues in their day-to-day practice. An inductive thematic analysis of the data was performed by two investigators, who reached a consensus on major themes using an iterative, dialogic process. Participants reported negotiating ethical issues frequently. Major themes included patient-doctor relationships, professional differences, truth-telling, ethically 'grey' areas and the personal demands of ethical decision making. General practitioners in this study describe sometimes needing to apply judgement and compromise in situations involving legal or ethical issues, in order to act in the best interests of patients and to successfully negotiate the patient-doctor relationship. Students learning in this clinical context may perceive mixed messages and ethical lapses in these challenging 'grey' areas. The ethical acumen and emotional resilience of both students and clinical teachers may be enhanced by ongoing reflective discussion with colleagues.

ASD Closure in Structural Heart Disease.

PubMed

Wiktor, Dominik M; Carroll, John D

2018-04-17

While the safety and efficacy of percutaneous ASD closure has been established, new data have recently emerged regarding the negative impact of residual iatrogenic ASD (iASD) following left heart structural interventions. Additionally, new devices with potential advantages have recently been studied. We will review here the potential indications for closure of iASD along with new generation closure devices and potential late complications requiring long-term follow-up. With the expansion of left-heart structural interventions and large-bore transseptal access, there has been growing experience gained with management of residual iASD. Some recently published reports have implicated residual iASD after these procedures as a potential source of diminished clinical outcomes and mortality. Additionally, recent trials investigating new generation closure devices as well as expanding knowledge regarding late complications of percutaneous ASD closure have been published. While percutaneous ASD closure is no longer a novel approach to managing septal defects, there are several contemporary issues related to residual iASD following large-bore transseptal access and new generation devices which serve as an impetus for this review. Ongoing attention to potential late complications and decreasing their incidence with ongoing study is clearly needed.

Potential Expanded Indications for Neprilysin Inhibitors

PubMed Central

Riddell, Elizabeth; Vader, Justin M.

2017-01-01

Purpose of review The goal of this article is to review potential expanded indications for neprilysin inhibitors. This article reviews the rationale and design for ongoing and future trials of sacubitril/valsartan in cardiovascular and non-cardiovascular disease. Recent findings Randomized trial data are lacking for use of sacubitril/valsartan in acute heart failure and advanced heart failure. Mechanistic data from animal studies suggest a role for neprilysin inhibition in the treatment of post-myocardial infarction systolic dysfunction and heart failure with preserved ejection fraction. Beyond the cardiovascular system, renal and neurological function may be impacted by neprilysin inhibition. Forthcoming randomized trials will address the clinical impact of sacubitril/valsartan on these conditions. Summary Neprolysin inhibition with sacubitril/valsartan offers a new therapeutic strategy with a broad range of potential therapeutic actions. In PARADIGM-HF, the combination of neprolysin and RAAS inhibition was proven to be superior to enalapril for patients with stable NYHA class II–III heart failure and reduced left ventricular ejection fraction. Preliminary data suggests it may also have a role in other cardiovascular and non-cardiovascular disease. Several ongoing and planned studies will determine the extent of its benefit for these other indications. PMID:28281174

Clinical applications of bioactive milk components

PubMed Central

Newburg, David S.

2015-01-01

Milk represents a unique resource for translational medicine: It contains a rich pool of biologically active molecules with demonstrated clinical benefits. The ongoing characterization of the mechanistic process through which milk components promote development and immunity has revealed numerous milk-derived compounds with potential applications as clinical therapies in infectious and inflammatory disease, cancer, and other conditions. Lactoferrin is an effective antimicrobial and antiviral agent in high-risk patient populations and a potentially potent adjuvant to chemotherapy in lung cancer. Enteric nutrition formulas supplemented with transforming growth factor β, a milk cytokine, have been shown to promote remission in pediatric Crohn's disease. A number of milk glycans, including human milk oligosaccharides, show promise in preclinical studies as antimicrobial and anti-inflammatory agents. While active preclinical investigations of human milk may soon result in large-scale production of human milk molecules, bovine milk components in many instances represent a practical source of bioactive milk compounds for use in clinical trials. This review summarizes current efforts to translate the compounds derived from human and bovine milk into effective clinical therapies. These efforts suggest a common pathway for the translation of milk-derived compounds into clinical applications. PMID:26011900

Clinical pharmacology of novel anti-Alzheimer disease modifying medications.

PubMed

Caraci, Filippo; Bosco, Paolo; Leggio, Gian Marco; Malaguarnera, Michele; Drago, Filippo; Bucolo, Claudio; Salomone, Salvatore

2013-01-01

In recent years, efforts have been directed to develop "disease-modifying" medications to treat Alzheimer's disease (AD), able to halt or slow the pathological process. Because the earlier the treatment starts, the greater is the possibility of efficacy, it is important to set up biomarkers for early diagnosis of functional brain abnormalities, before the clinical manifestation of the overt disease. Up to now, strategies to develop disease-modifying drugs have mainly targeted β amyloid (Aβ, accumulation, aggregation, clearance) and/or tau protein (phosphorylation and aggregation). Active and passive immunotherapy is the main strategy aimed at increasing Aβ clearance. Unfortunately several candidate diseasemodifying drugs have failed in phase III clinical trials conducted in mild to moderate AD. More recently, in phase III studies, bapineuzumab has been discontinued because it did not prove clinically effective (despite its significant effect on biomarkers), while solaneuzumab has been found effective in slowing AD progression. Several methological problems have been recently pointed out to explain the lack of clinical efficacy of novel disease-modifying drug-treatments; moreover, new insights in pathophysiology of AD give the premise to develop novel drug targeting. Clinical trials recently completed and/or still ongoing are discussed in the present review.

Examining the role of technology in learning: an evaluation of online clinical conferencing.

PubMed

Cooper, Cathy; Taft, Lois B; Thelen, Mary

2004-01-01

The rapidly expanding use of instructional technology requires faculty openness to new teaching and learning situations. This study compared two instructional methods of conducting clinical conferences for baccalaureate nursing students: online versus face-to-face. Quantitative and qualitative data were collected from 77 students in 10 clinical sections of a senior capstone nursing course. Mean scores for all 11 items on the clinical evaluation tool were higher for students who had conferences online than those in face-to-face conferences. Four of the 11 items were statistically significant, reflecting greater participation and convenience for online participants. Online students also reported greater opportunities to reflect on ethical issues. There were no significant differences in quiz scores between the groups when students were tested on content covered in their clinical conferences. Students identified advantages including opportunities for flexibility and equal participation. Barriers included unfamiliarity with technology and lack of face-to-face-contact. The findings suggest that students can successfully achieve the intended purpose of clinical conferences through an online instructional technique. Ongoing research in the use of technology is necessary to meet student needs, enhance student learning, and support evidence-based practice in nursing education.

Data Safe Havens and Trust: Toward a Common Understanding of Trusted Research Platforms for Governing Secure and Ethical Health Research

PubMed Central

Nicholls, Jacqueline; Dobbs, Christine; Sethi, Nayha; Cunningham, James; Ainsworth, John; Heaven, Martin; Peacock, Trevor; Peacock, Anthony; Jones, Kerina; Laurie, Graeme; Kalra, Dipak

2016-01-01

In parallel with the advances in big data-driven clinical research, the data safe haven concept has evolved over the last decade. It has led to the development of a framework to support the secure handling of health care information used for clinical research that balances compliance with legal and regulatory controls and ethical requirements while engaging with the public as a partner in its governance. We describe the evolution of 4 separately developed clinical research platforms into services throughout the United Kingdom-wide Farr Institute and their common deployment features in practice. The Farr Institute is a case study from which we propose a common definition of data safe havens as trusted platforms for clinical academic research. We use this common definition to discuss the challenges and dilemmas faced by the clinical academic research community, to help promote a consistent understanding of them and how they might best be handled in practice. We conclude by questioning whether the common definition represents a safe and trustworthy model for conducting clinical research that can stand the test of time and ongoing technical advances while paying heed to evolving public and professional concerns. PMID:27329087

Clinical applications of bioactive milk components.

PubMed

Hill, David R; Newburg, David S

2015-07-01

Milk represents a unique resource for translational medicine: It contains a rich pool of biologically active molecules with demonstrated clinical benefits. The ongoing characterization of the mechanistic process through which milk components promote development and immunity has revealed numerous milk-derived compounds with potential applications as clinical therapies in infectious and inflammatory disease, cancer, and other conditions. Lactoferrin is an effective antimicrobial and antiviral agent in high-risk patient populations and a potentially potent adjuvant to chemotherapy in lung cancer. Enteric nutrition formulas supplemented with transforming growth factor β, a milk cytokine, have been shown to promote remission in pediatric Crohn's disease. A number of milk glycans, including human milk oligosaccharides, show promise in preclinical studies as antimicrobial and anti-inflammatory agents. While active preclinical investigations of human milk may soon result in large-scale production of human milk molecules, bovine milk components in many instances represent a practical source of bioactive milk compounds for use in clinical trials. This review summarizes current efforts to translate the compounds derived from human and bovine milk into effective clinical therapies. These efforts suggest a common pathway for the translation of milk-derived compounds into clinical applications.

The Contextualization of Archetypes: Clinical Template Governance.

PubMed

Pedersen, Rune; Ulriksen, Gro-Hilde; Ellingsen, Gunnar

2015-01-01

This paper is a status report from a large-scale openEHR-based EPR project from the North Norway Regional Health Authority. It concerns the standardization of a regional ICT portfolio and the ongoing development of a new process oriented EPR systems encouraged by the unfolding of a national repository for openEHR archetypes. Subject of interest; the contextualization of clinical templates is governed over multiple national boundaries which is complex due to the dependency of clinical resources. From the outset of this, we are interested in how local, regional, and national organizers maneuver to standardize while applying OpenEHR technology.

The effect of endometrial injury on ongoing pregnancy rate in unselected subfertile women undergoing in vitro fertilization: a randomized controlled trial.

PubMed

Yeung, Tracy Wing Yee; Chai, Joyce; Li, Raymond Hang Wun; Lee, Vivian Chi Yan; Ho, Pak Chung; Ng, Ernest Hung Yu

2014-11-01

Does endometrial injury in the cycle preceding ovarian stimulation for in vitro fertilization (IVF) improve the ongoing pregnancy rate in unselected subfertile women? Endometrial injury induced by endometrial aspiration in the preceding cycle does not improve the ongoing pregnancy rate in unselected subfertile women undergoing IVF. Implantation failure remains one of the major limiting factors for IVF success. Mechanical endometrial injury in the cycle preceding ovarian stimulation of IVF treatment has been shown to improve implantation and pregnancy rates in women with repeated implantation failures. There is limited data on unselected subfertile women, especially those undergoing their first IVF treatment. This randomized controlled trial recruited 300 unselected subfertile women scheduled for IVF/ICSI treatment between March 2011 and August 2013. Subjects were randomized into endometrial aspiration (EA) (n = 150) and non-EA (n = 150) groups according to a computer-generated randomization list. Subjects were recruited and randomized in the assisted reproductive unit at the University of Hong Kong. In the preceding cycle, women in the EA group underwent endometrial aspiration using a Pipelle catheter in mid-luteal phase. All women were treated with a cycle of IVF/ICSI. Pregnancy outcomes were compared. There were no significant differences in baseline or cycle characteristics between the groups. There were 209 subjects (69.7%) who were undergoing their first IVF cycle and 91 (30.3%) subjects who had repeated cycles. There was no significant difference in ongoing pregnancy rates [26.7% (40/150) versus 32.0% (48/150); RR 0.833 (95% CI 0.585-1.187), P = 0.375] in the EA and non-EA groups. The implantation rates [32.8% (67/204) versus 29.7% (68/229); RR 1.080 (95% CI 0.804-1.450), P = 0.120], clinical pregnancy rates [34.0% (51/150) versus 38.0 (57/150); RR 0.895 (95% CI 0.661-1.211), P = 0.548], miscarriage rates [30.3% (17/56) versus 18.6% (11/59), RR 1.628 (95% CI 0.838-3.164), P = 0.150] and multiple pregnancy rates [31.3% (16/51) versus 19.3% (11/57), RR 1.626 (95% CI 0.833-3.172), P = 0.154] were all comparable between the EA and non-EA groups. Subgroup analysis in women having first embryo transfer (n = 209) also demonstrated no significant difference in ongoing pregnancy rates, but for women undergoing repeated cycles (n = 91), the on-going pregnancy rate was significantly lower in the EA group than in the non-EA group. The study aimed at assessing an unselected population of subfertile women by recruiting consecutive women attending our fertility clinic. However, since the majority of the recruited women (69.7%) were having their first IVF treatments, the results may not be generalizable to all women undergoing IVF. Previous RCTs and meta-analyses have suggested improved pregnancy rates after pretreatment endometrial injury in women with repeated implantation failure. A recent RCT also showed increased pregnancy rates in unselected subfertile women after endometrial injury, although that study was terminated early and thus underpowered. Our study showed with adequate power that no significant improvement in pregnancy rates was observed after endometrial injury in unselected women undergoing IVF treatment. The study was supported by the Small Project Funding 201309176012 of the Committee on Research and Conference Grants, University of Hong Kong. The authors have nothing to disclose. HKCTR-1646 and NCT 01977976. © The Author 2014. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

78 FR 18680 - Genomic Medicine Program Advisory Committee, Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-27

... DEPARTMENT OF VETERANS AFFAIRS Genomic Medicine Program Advisory Committee, Notice of Meeting The..., that the Genomic Medicine Program Advisory Committee will meet on April 11, 2013, in Suite 1000 at the... ongoing Million Veteran Program, as well as the clinical Genomic Medicine Service. The emerging...

Trailblazing Partnerships: Professional Development Schools in Partnership with Emporia State University

ERIC Educational Resources Information Center

Jones, Jill; Schwerdtfeger, Sara; Roop, Teddy; Long, Jennie L.

2016-01-01

Emporia State University is committed to preparing future elementary education teachers through the collaborative efforts and ongoing reflective practice between the university and school districts. The Professional Development School is the vehicle behind the structured involvement in the process of immersing student-teacher in a clinical model…

Meetings with Elaine, an African and Native American Woman

ERIC Educational Resources Information Center

O'Donnell, Melanie Merola

2006-01-01

The author, a Caucasian doctoral student of clinical psychology, examined her ongoing interaction with Elaine, an adult woman of African and Native American descent. Incidents of learning during the interaction process are reviewed and qualitative and quantitative assessments are provided to examine the effectiveness of such interactions in a…

Optical techniques in pulmonary medicine. SPIE photonics West.

PubMed

Suter, Melissa J; Lam, Stephen; Brenner, Matthew

2012-04-01

There is ongoing interest in the emerging field of pulmonary photonic-based diagnostics. Potential clinical need areas that are being actively investigated at this time include airway and peripheral lung cancer diagnostics, pulmonary parenchymal and interstitial disorders, alveolar structure function, inhalation injury, ciliary function analysis, asthma and obstructive lung diseases.

Metastatic melanoma: results of 'classical' second-line treatment with cytotoxic chemotherapies.

PubMed

Perrin, Christophe; Pracht, Marc; Talour, Karen; Adamski, Henri; Cumin, Isabelle; Porneuf, Marc; Talarmin, Marie; Mesbah, Habiba; Audrain, Odile; Moignet, Aline; Lefeuvre-Plesse, Claudia; Lesimple, Thierry

2014-10-01

Metastatic melanoma is one of the most aggressive tumours, with a median survival that does not exceed 12 months. None of the cytotoxic first-line therapies have shown survival benefit in randomised clinical trials. To describe clinical benefit of second-line cytotoxic chemotherapy in the second line of treatment for metastatic melanoma. In a retrospective study, we analyse the outcome of patients with metastatic melanoma who had received two lines or more of cytotoxic treatments in four French dermato-oncology departments between 1999 and 2009. We describe the outcomes for 109 patients. Most of these patients received dacarbazine for the first line of chemotherapy and fotemustine for the second line of chemotherapy (67.0 and 64.2%, respectively). A clinical benefit was observed in 24.1% of the patients and overall survival was 4.1 months after the second-line treatment. At least 23.8% of patients suffered from grade 3 or 4 toxicities. The presence of more than two sites of metastasis and an M1c staging according to the AJCC classification represented negative predictive factors of clinical benefit. This study shows the modest benefit of a second line of cytotoxic chemotherapy in a nonselected population. If eligible, these patients should be proposed for ongoing clinical trials or for targeted therapies.

[Shared decision-making in acute psychiatric medicine : Contraindication or a challenge?

PubMed

Heres, S; Hamann, J

2017-09-01

The concept of shared decision-making (SDM) has existed since the 1990s in multiple fields of somatic medicine but has only been poorly applied in psychiatric clinical routine despite broad acceptance and promising outcomes in clinical studies on its positive effects. The concept itself and its practicability in mental health are carefully assessed and strategies for its future implementation in psychiatric medicine are presented in this article. Ongoing clinical studies probing some of those strategies are further outlined. On top of the ubiquitous shortage of time in clinical routine, psychiatrists report their concern about patients' limited abilities in sharing decisions and their own fear of potentially harmful decisions resulting from a shared process. Misinterpretation of shared decision-making restricting the health care professional to rather an informed choice scenario and their own adhesion to the traditional paternalistic decision-making approach further add to SDM's underutilization. Those hurdles could be overcome by communication skill workshops for all mental health care professionals, including nursing personnels, psychologists, social workers and physicians, as well as the use of decision aids and training courses for patients to motivate and empower them in sharing decisions with the medical staff. By this, the patient-centered treatment approach demanded by guidelines, carers and users could be further facilitated in psychiatric clinical routine.

Tau-Centric Targets and Drugs in Clinical Development for the Treatment of Alzheimer's Disease

PubMed Central

Solfrizzi, Vincenzo; Imbimbo, Bruno P.; Lozupone, Madia; Santamato, Andrea; Zecca, Chiara; Barulli, Maria Rosaria; Bellomo, Antonello; Pilotto, Alberto; Daniele, Antonio; Greco, Antonio

2016-01-01

The failure of several Phase II/III clinical trials in Alzheimer's disease (AD) with drugs targeting β-amyloid accumulation in the brain fuelled an increasing interest in alternative treatments against tau pathology, including approaches targeting tau phosphatases/kinases, active and passive immunization, and anti-tau aggregation. The most advanced tau aggregation inhibitor (TAI) is methylthioninium (MT), a drug existing in equilibrium between a reduced (leuco-methylthioninium) and oxidized form (MT+). MT chloride (methylene blue) was investigated in a 24-week Phase II clinical trial in 321 patients with mild to moderate AD that failed to show significant positive effects in mild AD patients, although long-term observations (50 weeks) and biomarker studies suggested possible benefit. The dose of 138 mg/day showed potential benefits on cognitive performance of moderately affected AD patients and cerebral blood flow in mildly affected patients. Further clinical evidence will come from the large ongoing Phase III trials for the treatment of AD and the behavioral variant of frontotemporal dementia on a new form of this TAI, more bioavailable and less toxic at higher doses, called TRx0237. More recently, inhibitors of tau acetylation are being actively pursued based on impressive results in animal studies obtained by salsalate, a clinically used derivative of salicylic acid. PMID:27429978

An official multi-society statement: the role of clinical research results in the practice of critical care medicine.

PubMed

Tonelli, Mark R; Curtis, J Randall; Guntupalli, Kalpalatha K; Rubenfeld, Gordon D; Arroliga, Alejandro C; Brochard, Laurent; Douglas, Ivor S; Gutterman, David D; Hall, Jesse R; Kavanagh, Brian P; Mancebo, Jordi; Misak, Cheryl J; Simpson, Steven Q; Slutsky, Arthur S; Suffredini, Anthony F; Thompson, B Taylor; Ware, Lorraine B; Wheeler, Arthur P; Levy, Mitchell M

2012-05-15

While the results of clinical research are clearly valuable in the care of critically ill patients, the limitations of such information and the role of other forms of medical knowledge for clinical decision making have not been carefully examined. The leadership of three large professional societies representing critical care practitioners convened a diverse group representing a wide variety of views regarding the role of clinical research results in clinical practice to develop a document to serve as a basis for agreement and a framework for ongoing discussion. Consensus was reached on several issues. While the results of rigorous clinical research are important in arriving at the best course of action for an individual critically ill patient, other forms of medical knowledge, including clinical experience and pathophysiologic reasoning, remain essential. No single source of knowledge is sufficient to guide clinical decisions, nor does one kind of knowledge always take precedence over others. Clinicians will find clinical research compelling for a variety of reasons that go beyond study design. While clinical practice guidelines and protocols based upon clinical research may improve care and decrease variability in practice, clinicians must be able to understand and articulate the rationale as to why a particular protocol or guideline is used or why an alternative approach is taken. Making this clinical reasoning explicit is necessary to understand practice variability. Understanding the strengths and weaknesses of different kinds of medical knowledge for clinical decision making and factors beyond study design that make clinical research compelling to clinicians can provide a framework for understanding the role of clinical research in practice.

Selexipag in Pulmonary Arterial Hypertension: Most Updated Evidence From Recent Preclinical and Clinical Studies.

PubMed

Ghosh, Raktim K; Ball, Somedeb; Das, Avash; Bandyopadhyay, Dhrubajyoti; Mondal, Samhati; Saha, Debjit; Gupta, Anjan

2017-05-01

Pulmonary arterial hypertension (PAH) is a relatively rare disease that, due to its chronic nature, has always been difficult to treat effectively. Selexipag is an oral prostacyclin (PGI 2 ) agonist that was approved by US Food and Drug Administration (US FDA) in December 2015 for the treatment of PAH. After its success in phase 1 and phase 2 clinical trials regarding the convenient oral twice-daily dosing and low side-effect profile, selexipag raised the hope of controlling the disease progression in PAH patients. In the recently completed multicentered phase 3 study (GRIPHON), selexipag has been shown to reduce death and hospitalization due to PAH significantly, an effect that was consistent across different ranges of maintenance dose. In the same study selexipag use was also associated with an increase in 6-minute walk distance (a measure of symptom severity) from baseline, but no significant improvement in all-cause mortality could be observed. The results of the ongoing phase 3 studies (TRITON and TRANSIT-1) are expected to throw some more light on the safety and efficacy of this novel molecule across various treatment scenarios. Hence, our article aims to summarize all the available information from preclinical and clinical studies published to date on the pharmacodynamics, pharmacokinetics, efficacy, safety (in general and in scenarios such as hepatic and renal function impairment), significant drug interactions (with warfarin and antiretroviral drugs), and clinical significance of oral selexipag in patients with PAH. © 2016, The American College of Clinical Pharmacology.

Use of mobile devices in nursing student-nurse teacher cooperation during the clinical practicum: an integrative review.

PubMed

Strandell-Laine, Camilla; Stolt, Minna; Leino-Kilpi, Helena; Saarikoski, Mikko

2015-03-01

To identify and appraise study findings on the use of mobile devices, in particular for what purposes and how, in nursing student-nurse teacher cooperation during the clinical practicum. A systematic literature search was conducted using the PubMed/Medline, CINAHL, PsycINFO and ERIC for primary empirical studies published in English. An integrative literature review was undertaken. Quality appraisal of the included studies was conducted using design-specific standardized checklists. Studies were thematically analyzed. Based on the inclusion and exclusion criteria, eleven studies were included in the review. Weaknesses in designs, samples, questionnaires and results, compromised comparison and/or generalization of the findings of the studies. Three main themes were identified: (1) features of mobile devices (2) utility of mobile devices and (3) barriers to the use of mobile devices. Problems of connectivity were the main challenges reported in the use of mobile devices. Participants used mobile devices primarily as reference tools, but less frequently as tools for reflection, assessment or cooperation during the clinical practicum. Interest in mobile device use during the clinical practicum was reported, but training and ongoing support are needed. As only a small number of eligible primary empirical studies were found, it is not possible to draw firm conclusions on the results. In the future, rigorous primary empirical studies are needed to explore the potential of mobile devices in providing a supplementary pedagogical method in nursing student-nurse teacher cooperation during the clinical practicum. Robust study designs, including experimental ones, are clearly needed to assess the effectiveness of mobile devices in nursing student-nurse teacher cooperation during the clinical practicum. Copyright © 2014 Elsevier Ltd. All rights reserved.

M25. Development and Validation of the Brief Assessment of Validation in Schizophrenia (BAC-App)

PubMed Central

Atkins, Alexandra; Tseng, Tina; Vaughan, Adam; Harvey, Philip; Narasimhan, Meera; Patterson, Tom; Khan, Anzalee; Keefe, Richard

2017-01-01

Abstract Background: The Brief Assessment of Cognition in Schizophrenia (BACS) is a pen-and-paper cognitive assessment tool that has been used in hundreds of research studies and clinical trials, and has normative data available for generating age- and gender-corrected standardized scores. A tablet-based version of the BACS called the BAC App has been developed to allow standardized presentation of task instructions and stimuli, audio-recording of subject responses, and automatized scoring and data management. Development of the BAC App was aimed at reducing rater burden and variability. Our validation study compared performance on the traditional BACS and the BAC App in patients with schizophrenia and healthy controls. Test equivalency was assessed, and the applicability of paper-based normative data was evaluated. An ongoing follow-up study examines BAC App performance in large-scale census-matched normative sample. Methods: Participants in the validation study included 48 patients (23 female) with schizophrenia and 50 healthy controls (25 female) recruited from 3 academic sites including the University of California-San Diego, the University of Miami—Miller School of Medicine, and the University of South Carolina. All participants were assessed with the standard pen-and-paper BACS and the BAC App. Ongoing normative evaluation of the BAC App will include a community sample of 650 individuals matched to the US census on age, education, race and gender. Results: In the validation study, distributions of standardized composite scores for the tablet-based BAC App and the pen-and-paper BACS were indistinguishable in both schizophrenia patients and healthy controls. Between-methods mean differences were not statistically significant. The discrimination between patients and controls was similarly robust with the BAC App (d = 1.34) and the BACS (d = 1.24). The between-methods correlations for individual measures in patients were r > .70 except Token Motor (r = .43) and Tower of London (r = .61). In patients, performance between the test methods was not significantly different on any test except the Token Motor Test. When data from the Token Motor Test were removed, the between-methods correlation of composite scores improved to r = .88 (df = 48; P <.001) in healthy controls and r = .89 (df = 46; P < .001) in patients, consistent with the test-retest reliability of each measure. Interim findings from the ongoing normative study (N = 52 to date) suggest that the BAC App is well-tolerated by a diverse community population, with 78.9% (N = 41) of subjects rating their experience with the BAC App as “pleasant” on a 7-point Likert scale. Conclusion: The tablet-based BAC App is generates results consistent with the traditional pen-and-paper BACS. These data support the notion that the BAC App can now be used in clinical trials and clinical practice.

Clinical trials in progressive multiple sclerosis: lessons learned and future perspectives

PubMed Central

Ontaneda, Daniel; Fox, Robert J.; Chataway, Jeremy

2015-01-01

Progressive multiple sclerosis is characterized by the gradual accrual of disability independent of relapses and can occur with disease onset (primary progressive) or preceded by a relapsing disease course (secondary progressive). An effective disease modifying treatment for progressive multiple sclerosis has not been identified, and the results of clinical trials to date have been generally disappointing. Ongoing advances in our understanding of pathogenesis, identification of novel targets for neuro-protection, and improved outcome measures have the potential to lead to effective treatments for progressive multiple sclerosis. In this review lessons learned from previous clinical trials and perspectives from current trials in progressive multiple sclerosis are summarized. Promising clinical, imaging, and biological markers will also be reviewed, along with novel clinical trial designs. PMID:25772899

Changes in pathology test ordering by early career general practitioners: a longitudinal study.

PubMed

Magin, Parker J; Tapley, Amanda; Morgan, Simon; Henderson, Kim; Holliday, Elizabeth G; Davey, Andrew R; Ball, Jean; Catzikiris, Nigel F; Mulquiney, Katie J; van Driel, Mieke L

2017-07-17

To assess the number of pathology tests ordered by general practice registrars during their first 18-24 months of clinical general practice. Longitudinal analysis of ten rounds of data collection (2010-2014) for the Registrar Clinical Encounters in Training (ReCEnT) study, an ongoing, multicentre, cohort study of general practice registrars in Australia. The principal analysis employed negative binomial regression in a generalised estimating equations framework (to account for repeated measures on registrars).Setting, participants: General practice registrars in training posts with five of 17 general practice regional training providers in five Australian states. The registrar participation rate was 96.4%. Number of pathology tests requested per consultation. The time unit for analysis was the registrar training term (the 6-month full-time equivalent component of clinical training); registrars contributed data for up to four training terms. 876 registrars contributed data for 114 584 consultations. The number of pathology tests requested increased by 11% (95% CI, 8-15%; P < 0.001) per training term. Contrary to expectations, pathology test ordering by general practice registrars increased significantly during their first 2 years of clinical practice. This causes concerns about overtesting. As established general practitioners order fewer tests than registrars, test ordering may peak during late vocational training and early career practice. Registrars need support during this difficult period in the development of their clinical practice patterns.

Paternal history of mental illness associated with posttraumatic stress disorder among veterans.

PubMed

Shepherd-Banigan, Megan; Kelley, Michelle L; Katon, Jodie G; Curry, John F; Goldstein, Karen M; Brancu, Mira; Wagner, H Ryan; Fecteau, Teresa E; Van Houtven, Courtney H

2017-10-01

This study examined the association between parent and family reported history of non-PTSD mental illness (MI), PTSD specifically, and substance use problems, and participant clinical diagnosis of PTSD. Participants were drawn from the US Department of Veterans Affairs Mid-Atlantic Mental Illness Research, Education and Clinical Center (MIRECC) Post-Deployment Mental Health (PDMH) study (n = 3191), an ongoing multi-site cohort study of US Afghanistan and Iraq conflict era veterans. Participants who recalled a father history of PTSD had a 26-percentage point higher likelihood of meeting criteria for PTSD; while participants reporting any family history of PTSD had a 15-percentage point higher probability of endorsing symptoms consistent with PTSD. Mother history of substance use problems was associated with Veteran current PTSD, but results were sensitive to model specification. Current PTSD was not associated with family/parent history of non-PTSD mental illness, mother history of PTSD, or family/father history of substance use problems. Family history of PTSD may increase PTSD risk among veterans exposed to trauma, particularly when a father history is reported. Knowledge of family history could improve clinical decision-making for trauma-exposed individuals and allow for more effective targeting of programs and clinical services. Published by Elsevier B.V.

Endovascular therapy for acute ischemic stroke.

PubMed

Broderick, Joseph P

2009-03-01

To review advances in endovascular therapy for acute ischemic stroke. Data from primate studies, randomized studies of intravenous recombinant tissue-type plasminogen activator, and nonrandomized and randomized studies of endovascular therapy were reviewed. Clinical trial data demonstrate the superiority of endovascular treatment with thrombolytic medication or mechanical methods to reopen arteries compared with control patients from the PROACT II Trial treated with heparin alone. However, these same clinical trials, as well as preclinical primate models, indicate that recanalization, whether by endovascular approaches or standard-dose recombinant tissue-type plasminogen activator, is unlikely to improve clinical outcome after a certain time point. Although the threshold beyond which reperfusion has no or little benefit has yet to be conclusively defined, accumulated data to this point indicate an overall threshold of approximately 6 to 7 hours. In addition, although the risk of symptomatic intracerebral hemorrhage is similar in trials of intravenous lytics and endovascular approaches, endovascular approaches have distinctive risk profiles that can impact outcome. The treatment of acute ischemic stroke is evolving with new tools to reopen arteries and salvage the ischemic brain. Ongoing randomized trials of these new approaches are prerequisite next steps to demonstrate whether reperfusion translates into clinical effectiveness. Physiologic time to reperfusion will remain critical no matter which tools prove most effective and safest.

A study of intrauterine infusion of human chorionic gonadotropin (hCG) before frozen-thawed embryo transfer after two or more implantation failures.

PubMed

Huang, Pinxiu; Wei, Lihong; Li, Xinlin

2017-01-01

To investigate the effect of intrauterine infusion of human chorionic gonadotropin (hCG) before frozen-thawed embryo transfer (FET) after two or more implantation failures (TIFs). The study was a prospective randomized single-blind study of 161 cycles in patients undergoing FET who had TIFs. The intervention group received an intrauterine injection of 1000 IU of hCG before embryo transfer (ET) (n = 62). A placebo group (n = 49) received an intrauterine injection of physiological saline before ET. A control group (n = 50) did not receive an intrauterine injection. Clinical pregnancy rates, abortion rates, and ongoing pregnancy rates were compared between the three groups. The clinical pregnancy rates were 59.68%, 53.06%, and 32.00% in the hCG group, placebo group, and control group, respectively. The clinical pregnancy rates were significantly higher in the hCG and placebo groups than in the control group. There were no significant differences in the abortion rates among the three groups. An intrauterine administration of hCG before FET significantly improved the pregnancy rates after TIFs. But local injury caused by the operation of intrauterine perfusion may play an important role in improving clinical pregnancy rates.

Essential features influencing collaboration in team-based non-specific back pain rehabilitation: Findings from a mixed methods study

PubMed Central

Hellman, Therese; Jensen, Irene; Bergström, Gunnar; Brämberg, Elisabeth Björk

2016-01-01

ABSTRACT The aim of the study presented in this article was to explore how professionals, without guidelines for implementing interprofessional teamwork, experience the collaboration within team-based rehabilitation for people with back pain and how this collaboration influences their clinical practice. This study employed a mixed methods design. A questionnaire was answered by 383 participants and 17 participants were interviewed. The interviews were analysed using content analysis. The quantitative results showed that the participants were satisfied with their team-based collaboration. Thirty percent reported that staff changes in the past year had influenced their clinical practice, of which 57% reported that these changes had had negative consequences. The qualitative findings revealed that essential features for an effective collaboration were shared basic values and supporting each other. Furthermore, aspects such as having enough time for reflection, staff continuity, and a shared view of the team members’ roles were identified as aspects which influenced the clinical practice. Important clinical implications for nurturing and developing a collaboration in team-based rehabilitation are to create shared basic values and a unified view of all team members’ roles and their contributions to the team. These aspects need to be emphasised on an ongoing basis and not only when the team is formed. PMID:27152534

Laboratory and clinical experience with neodymium:YAG laser prostatectomy

NASA Astrophysics Data System (ADS)

Kabalin, John N.

1996-05-01

Since 1991, we have undertaken extensive laboratory and clinical studies of the Neodymium:YAG (Nd:YAG) laser for surgical treatment of bladder outlet obstruction due to prostatic enlargement or benign prostatic hyperplasia (BPH). Side-firing optical fibers which emit a divergent, relatively low energy density Nd:YAG laser beam produce coagulation necrosis of obstructing periurethral prostate tissue, followed by gradual dissolution and slough in the urinary stream. Laser-tissue interactions and Nd:YAG laser dosimetry for prostatectomy have been studied in canine and human prostate model systems, enhancing clinical application. Ongoing studies examine comparative Nd:YAG laser dosimetry for various beam configurations produced by available side-firing optical fibers and continue to refine operative technique. We have documented clinical outcomes of Nd:YAG laser prostatectomy in 230 consecutive patients treated with the UrolaseTM side-firing optical fiber. Nd:YAG laser coagulation the prostate produces a remarkably low acute morbidity profile, with no significant bleeding or fluid absorption. No postoperative incontinence has been produced. Serial assessments of voiding outcomes over more than 3 years of followup show objective and symptomatic improvement following Nd:YAG laser prostatectomy which is comparable to older but more morbid electrosurgical approaches. Nd:YAG laser prostatectomy is a safe, efficacious, durable and cost-effective treatment for BPH.

Clinical and radiological outcomes after treatment of sagittal fracture of mandibular condyle (SFMC) by using occlusal splint in children.

PubMed

Liu, Chang-Kui; Meng, Fan-Wen; Tan, Xin-Ying; Xu, Juan; Liu, Hua-Wei; Liu, San-Xia; Huang, Hai-Tao; Yan, Rong-Zeng; Hu, Min; Hu, Kai-Jin

2014-02-01

This study was designed to investigate the effects of occlusal splints in the treatment of sagittal fractures of the mandibular condyle in children. From January 1995 to December 2011, 37 sagittal fractures of the mandibular condyle in 30 patients aged 4-8 years old were included in this study. All the patients were treated with 1-2mm occlusal splints in the molar region. The mouths of the patients were kept slightly open by the occlusal splints for 3-6 months, and we reviewed the clinical and radiological remodelling of the affected condyles after treatment. Excellent (n=20) and good (n=10) clinical outcomes were achieved with full radiological remodelling seen in 19 and partial remodelling in 11. Treatment with occlusal splints is effective in delivering good results and function with minimal morbidity in children with sagittal fractures of the condyle, while permitting ongoing remodelling and growth in the short term. Copyright © 2013 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Financial remuneration for clinical and behavioral research participation: ethical and practical considerations.

PubMed

Permuth-Wey, Jennifer; Borenstein, Amy R

2009-04-01

Although the practice of providing payment to clinical research participants has been ongoing for more than a century, it remains an ethically controversial topic among members of the research community. The aims of this commentary are to summarize ethical and practical considerations regarding financial remuneration of research participants and to make recommendations for researchers contemplating this practice. A PubMed search was conducted to explore the ethical implications surrounding financial remuneration and review the body of empiric data on this topic. Financial remuneration is perceived to be ethically acceptable by many researchers and research participants and can be helpful in the recruitment process. It is recommended that when investigators are contemplating whether to offer payment to research participants, they should consider the nature of the study and the potential benefits and risks to the participants, institutional or organizational guidelines, and cultural and societal norms specific to the population being studied. Financial remuneration has the ability to serve as a sign of appreciation for the contributions of research participants and a way to facilitate clinical and behavioral research.

Individuals with excessive alcohol intake recruited by advertisement: demographic and clinical characteristics.

PubMed

Berglund, Kristina; Fahlke, Claudia; Berggren, Ulf; Eriksson, Matts; Balldin, Jan

2006-01-01

Studies have shown that most individuals with alcohol problems have never received any treatment for their alcoholism. The purpose of the present study was to describe demographic and clinical characteristics in male individuals with excessive alcohol intake who were recruited by advertisements. These characteristics were compared between individuals with or without prior treatment histories. Subjects (n = 367) responded to the advertisements in a regional daily newspaper and called the investigators. A structured interview was performed and a complete dataset of demographic and clinical information was collected in 342 individuals. Individuals with no prior treatment history (n = 238) were found to be more often cohabitant, employed, and they reported fewer on-going psychiatric symptoms than individuals with treatment histories (n = 104). Since individuals with no prior treatment history seldom experience psychiatric symptoms, they are less likely to seek treatment in the health care system. It is therefore of importance to find ways to reach this 'hidden' group early with excessive alcohol consumption. One way to do so might be via alcohol treatment programs at working places since the majority of them are employed.