Simulation of Front Instabilities in Density-Driven Flow, Using a Reactive Transport Model for Biogrout Combined with a Randomly Distributed Permeability Field

Abstract

Biogrout is a method to strengthen granular soil, which is based on microbial-induced carbonate precipitation. To model the Biogrout process, a reactive transport model is used. Since high flow rates are undesirable for the Biogrout process, the model equations can be solved with a standard Galerkin finite element method. The Biogrout process involves the injection of dense fluids in the subsurface. In this paper, we present our reactive transport model for Biogrout and use it to simulate an experiment in which a pulse of a dense fluid is injected in a porous medium filled with water. In this experiment, front instabilities were observed in the form of fingers. The numerical simulations showed that the fingering phenomenon was less pronounced than in the experiment. By reducing the dispersion length and implementing a randomly distributed permeability field, the fingering phenomenon could be induced. Furthermore, the results of a case study to a Biogrout application are reported.

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Evaluation of the add-on NOWAPI® medical device for remote monitoring of compliance to Continuous Positive Airway Pressure and treatment efficacy in obstructive sleep apnea

Optimizing the measurement of Continuous Positive Airway Pressure (CPAP) compliance and treatment efficacy is paramount for patients with obstructive sleep apnea syndrome (OSAS). Compliance knowledge is curren…

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Increasing diagnostic accuracy to grade dysplasia in Barrett’s esophagus using an immunohistochemical panel for CDX2, p120ctn, c-Myc and Jagged1

Patients with non-dysplastic Barrett's esophagus (ND-BE) and low-grade dysplasia (LGD) are typically monitored by periodic endoscopic surveillance, while those with high-grade dysplasia (HGD) and esophageal ad…

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A patient decision aid for antidepressant use in pregnancy: study protocol for a randomized controlled trial

Abstract

Background

Many women with depression experience significant difficulty making a decision about whether or not to use antidepressant medication in pregnancy. Patient decision aids (PDAs) are tools that assist patients in making complex health decisions. PDAs can reduce decision-making difficulty and lead to better treatment outcomes. We describe the methods for a pilot randomized controlled trial of an interactive web-based PDA for women who are having difficulty deciding about antidepressant drug use in pregnancy.

Methods/Design

This is a pilot randomized controlled trial that aims to assess the feasibility of a larger, multi-center efficacy study. The PDA aims to help a woman: (1) understand why an antidepressant is being recommended, (2) be knowledgeable about potential benefits and risks of treatment and non-treatment with antidepressants, and (3) be clear about which benefits and risks are most important to her, with the goal of improving confidence in her decision-making. We include women aged 18 years or older who are: (1) planning a pregnancy or are pregnant (gestational age less than 30 weeks), (2) diagnosed with major depressive disorder, (3) deciding whether or not to use a selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI) antidepressant in pregnancy, and (4) having at least moderate decision-making difficulty as per a Decisional Conflict Scale (DCS) Score ≥25. Participants are randomized to receive the PDA or an informational resource sheet via a secure website, and have access to the stated allocation until their final study follow-up. The primary outcomes of the pilot study are feasibility of recruitment and retention, acceptability of the intervention, and adherence to the trial protocol. The primary efficacy outcome is DCS score at 4 weeks post randomization, with secondary outcomes including depressive and anxiety symptoms.

Discussion

Our PDA represents a key opportunity to optimize the decision-making process for women around antidepressants in pregnancy, leading to effective decision-making and optimizing improved maternal and child outcomes related to depression in pregnancy. The electronic nature of the PDA will facilitate keeping it up-to-date, and allow for widespread dissemination after efficacy is demonstrated.

Trial registration

This trial is registered on ClinicalTrials.Gov under the identifier NCT02308592 (first registered: 2 December 2014).

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Hypoxia-Sensitive Materials for Biomedical Applications

Abstract

Hypoxia is a typical hallmark of various diseases, including cancer, ischemic diseases, and stroke. It is also associated with the disease progression. Therefore, it is critical to develop an effective strategy to target the hypoxic region for diagnosis and treatment. In this review, we summarize recent progress in the development of hypoxia-responsive systems for imaging, sensing and therapy. Two types of hypoxia-sensitive systems, the hypoxia inducible factor-1 based systems and bioreductive molecule based systems, were reviewed with comments on their advantages and limitations. Future opportunities and challenges are also discussed in the end.

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Increasing the survival of transverse rectus abdominis musculocutaneous flaps with a Botulinum Toxin-A Injection: A comparison of surgical and chemical flap delay methods

Botulinum Toxin type-A (Btx-A) is a commonly used drug for both cosmetic and therapeutic purposes. The effects of Btx-A on skin and muscle flaps and the related mechanisms have been described previously. In this study, we used a rat transverse rectus abdominis musculocutaneous (TRAM) flap model to examine the effects of Btx-A on the skin island, which is perfused by the rectus abdominis muscle according to the angiosome concept.

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Forkhead Box O1 Regulates Macrophage Polarization Following Staphylococcus aureus Infection: Experimental Murine Data and Review of the Literature

Abstract

The functions of macrophages that lead to effective host responses are critical for protection against Staphylococcus aureus. Deep tissue-invading S. aureus initially countered by macrophages trigger macrophage accumulation and induce inflammatory responses through surface receptors, especially toll-like receptor 2 (TLR2). Here, we found that macrophages formed sporadic aggregates in the liver during infection. Within those aggregates, macrophages co-localized with T cells and were indispensable for their infiltration. In addition, we have focused on the mechanisms underlying the polarization of macrophages in Forkhead box transcription factor O1 (FoxO1) conditional knockout Lys Cre/+FoxO1 fl/fl mice following S. aureus infection and report herein that macrophage M1-M2 polarization via TLR2 is intrinsically regulated by FoxO1. Indeed, for effective FoxO1 activity, stimulation of TLR2 is essential. However, following S. aureus challenge, there was a decrease in macrophage FoxO1, with increased phosphorylation of FoxO1 because of TLR2-mediated activation of PI3K/Akt and c-Raf/MEK/ERK pathway. Following infection in Lys Cre/+FoxO1 fl/fl mice, mice became more susceptible to S. aureus with reduced macrophage aggregation in the liver and attenuated Th1 and Th17 responses. FoxO1 abrogation reduced M1 pro-inflammatory responses triggered by S. aureus and enhanced M2 polarization in macrophages. In contrast, overexpression of FoxO1 in macrophages increased pro-inflammatory mediators and functional surface molecule expression. In conclusion, macrophage FoxO1 is critical to promote M1 polarization and maintain a competent T cell immune response against S. aureus infection in the liver. FoxO1 regulates macrophage M1-M2 polarization downstream of TLR2 dynamically through phosphorylation.

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Transmission of Hepatitis E Virus by Plasma Exchange: A Case Report

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The origin of the dorsal scapular artery: anatomic variations and surgical applications

Abstract

The dorsal scapular artery (DSA) can be either a direct branch of the subclavian artery (SCA), or a branch of the transverse cervical artery (TCA). In mandibular reconstruction, when a free flap is contraindicated a pedicled scapular flap has been described vascularized by the DSA. During the dissection of this flap, there is a risk of lesion of the TCA, which could be fatal to the flap if the DCA is a branch of the TCA. To evaluate the frequency of this anatomic situation, a dissection and radiologic study has been performed. 50 anatomic dissections on fresh cadavers and 93 arteriographies from 47 patients have been studied, to determine what was the DSA origin. In our dissections we found the origin of the DSA was a type I origin in 19 cases (38 %), a type II in 19 cases (38 %) and a type III in 12 cases (24 %). In our radiologic study, the DSA and the TCA had a common origin from the SCA (Type I) in 57/93 cases (61.3 %), the DSA was a direct branch of the SCA and the TCA (type II) in 22/93 cases (23.7 %), the DSA and the TCA had a common origin from the TCT (type III) in 14/93 cases (15 %). The DSA is coming from the TCA in 1/5 cases. A careful dissection of this flap in the subclavian area is necessary in all cases, a preoperative arteriography could be proposed to limit the risk of pedicle injury.

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Platysma flap using dual skin paddles

The platysma myocutaneous flap is rarely reported as an option for reconstruction in the head and neck. In our experience it is a reliable flap that is easy to raise, has a limited risk of morbidity at the donor site, and allows for early recommencement of oral function. We report a patient with an unusually aggressive orocutaneous fistula that complicated the simple extraction of teeth. We modified the platysma flap to provide two independent skin paddles so we could reconstruct both the intraoral and cutaneous defects simultaneously with a good clinical outcome.

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Efficacy of virtual reality exposure therapy for treatment of dental phobia: a randomized control trial

Abstract

Background

Virtual Reality Exposure Therapy (VRET) is found to be a promising and a viable alternative for in vivo exposure in the treatment of specific phobias. However, its usefulness for treating dental phobia is unexplored. The aims of the present study are to determine: (a) the efficacy of VRET versus informational pamphlet (IP) control group in terms of dental trait and state anxiety reductions at 1 week, 3 months and 6 months follow-up (b) the real-time physiological arousal [heart rate (HR)] of VRET group participants during and following therapy (c) the relation between subjective (presence) and objective (HR) measures during VRET.

Methods

This study is a single blind, randomized controlled trial with two parallel arms in which participants will be allocated to VRET or IP with a ratio of 1:1. Thirty participants (18-50 years) meeting the Phobia Checklist criteria of dental phobia will undergo block randomization with allocation concealment. The primary outcome measures include participants' dental trait anxiety (Modified Dental Anxiety Scale and Dental Fear Survey) and state anxiety (Visual Analogue Scale) measured at baseline (T0), at intervention (T1), 1-week (T2), 3 months (T3) and 6 months (T4) follow-up. A behavior test will be conducted before and after the intervention. The secondary outcome measures are real-time evaluation of HR and VR (Virtual Reality) experience (presence, realism, nausea) during and following the VRET intervention respectively. The data will be analyzed using intention-to-treat and per-protocol analysis.

Discussion

This study uses novel non-invasive VRET, which may provide a possible alternative treatment for dental anxiety and phobia.

Trial registration number

ISRCTN25824611, Date of registration: 26 October 2015.

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Impact of routine coronary catheterization in low extremity artery disease undergoing percutaneous transluminal angioplasty: study protocol for a multi-center randomized controlled trial

Abstract

Background

The prevalence of significant obstructive coronary artery disease with complex lesions is high in patients who have low extremity artery disease (LEAD). However, intermediate- or long-term cardiovascular prognosis of LEAD patients undergoing percutaneous transluminal angioplasty (PTA) remains poor. Accordingly, prophylactic coronary revascularization may modify short- and long-term cardiovascular outcomes of LEAD patients receiving PTA. Because myocardial ischemic symptoms are often masked in LEAD and the accuracy of non-invasive stress tests is usually limited, a high-quality randomized controlled trial aimed at the investigation of the prognostic role of coronary evaluation strategies before PTA is warranted.

Methods/Design

The proposed study is designed as a prospective, multi-center, open-label, superiority, randomized controlled trial. The study is conducted in high-volume centers for PTA and coronary revascularization in Taiwan. To meet the inclusion criteria, the patients must be at least 20 years old, have known LEAD, and have been admitted for elective PTA. We plan to enroll 450 participants who are randomly allocated to a routine group (routine coronary angiography without a previous non-invasive stress test before PTA) and a selective group (selective coronary angiography based on the results of non-invasive stress tests before PTA) with 1:1 ratio. Besides, we expect to enroll about 250 additional participants, who are not willing to be randomly assigned, in the registration group. The choice of revascularization procedure depends on the operator's or cardiovascular team's suggestion and the patient's decision. Clinical follow-up will be performed 30 days after PTA and every 6 months until the end of the 1-year follow-up for the last randomly assigned participant. The primary endpoint is the composite major adverse cardiac event on long-term follow-up. Pre-specified secondary and other endpoints are also evaluated. Those assessing biomarkers and clinical endpoints are all blinded after assignment to interventions.

Discussion

The results of the trial will, for the first time, support better decision-making for coronary evaluation before PTA in LEAD. If favorable, routine coronary angiography followed by revascularization will improve cardiovascular outcomes in LEAD patients undergoing PTA.

Trial registration

ClinicalTrials.gov identifier: NCT02169258 (registered on 21 June 2014); registry name: Routine Coronary Catheterization in Low Extremity Artery Disease Undergoing Percutaneous Transluminal Angioplasty (PIROUETTE-PTA).

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The clinical and cost effectiveness of cognitive behavioural therapy plus treatment as usual for the treatment of depression in advanced cancer (CanTalk): study protocol for a randomised controlled trial

Abstract

Background

The prevalence of depressive disorder in adults with advanced cancer is around 20 %. Although cognitive behavioural therapy (CBT) is recommended for depression and may be beneficial in depressed people with cancer, its use for depression in those with advanced disease for whom cure is not likely has not been explored.

Methods

People aged 18 years and above with advanced cancer attending General Practitioner (GP), oncology or hospice outpatients from centres across England will be screened to establish a DSM-IV diagnosis of depression. Self-referral is also accepted. Eligible consenters will be randomised to a single blind, multicentre, randomised controlled trial of the addition to treatment as usual (TAU) of up to 12 one-hour weekly sessions of manualised CBT versus TAU alone. Sessions are delivered in primary care through Increasing Access to Psychological Care (IAPT) service, and the manual includes a focus on issues for people approaching the end of life. The main outcome is the Beck Depression Inventory-II (BDI-II). Subsidiary measures include the Patient Health Questionnaire, quality of life measure EQ-5D, Satisfaction with care, Eastern Cooperative Oncology Group-Performance Status and a modified Client Service Receipt Inventory. At 90 % power, we require 240 participants to enter the trial. Data will be analysed using multi-level (hierarchical) models for data collected at baseline, 6, 12, 18 and 24 weeks. Cost effectiveness analysis will incorporate costs related to the intervention to compare overall healthcare costs and QALYs between the treatment arms. We will conduct qualitative interviews after final follow-up on patient and therapist perspectives of the therapy.

Discussion

This trial will provide data on the clinical and cost effectiveness of CBT for people with advanced cancer and depression. We shall gain an understanding of the feasibility of delivering care to this group through IAPT. Our findings will provide evidence for policy-makers, commissioners and clinicians in cancer and palliative care, and in the community.

Trial registration

Controlled Trials ISRCTN07622709, registered 15 July 2011.

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Liquid Biopsy Clinical Research – Tracking Mutations in cfDNA and CTCs

Advances in technology such as automated end-to-end solutions are allowing clinical researchers to study tough liquid biopsy samples. Leaders in the field have designed next- generation sequencing (NGS) assays that target critical questions in cancer research and tumor biology. We recently caught up with Dr. Luca Quagliata, MD, of University Hospital, Basel, Switzerland. We discussed tracking Read the rest of this article

The post Liquid Biopsy Clinical Research – Tracking Mutations in cfDNA and CTCs appeared first on Accelerating Science.

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Simulation of Front Instabilities in Density-Driven Flow, Using a Reactive Transport Model for Biogrout Combined with a Randomly Distributed Permeability Field

Abstract

Biogrout is a method to strengthen granular soil, which is based on microbial-induced carbonate precipitation. To model the Biogrout process, a reactive transport model is used. Since high flow rates are undesirable for the Biogrout process, the model equations can be solved with a standard Galerkin finite element method. The Biogrout process involves the injection of dense fluids in the subsurface. In this paper, we present our reactive transport model for Biogrout and use it to simulate an experiment in which a pulse of a dense fluid is injected in a porous medium filled with water. In this experiment, front instabilities were observed in the form of fingers. The numerical simulations showed that the fingering phenomenon was less pronounced than in the experiment. By reducing the dispersion length and implementing a randomly distributed permeability field, the fingering phenomenon could be induced. Furthermore, the results of a case study to a Biogrout application are reported.

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Evaluation of the add-on NOWAPI® medical device for remote monitoring of compliance to Continuous Positive Airway Pressure and treatment efficacy in obstructive sleep apnea

Optimizing the measurement of Continuous Positive Airway Pressure (CPAP) compliance and treatment efficacy is paramount for patients with obstructive sleep apnea syndrome (OSAS). Compliance knowledge is curren…

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Increasing diagnostic accuracy to grade dysplasia in Barrett’s esophagus using an immunohistochemical panel for CDX2, p120ctn, c-Myc and Jagged1

Patients with non-dysplastic Barrett's esophagus (ND-BE) and low-grade dysplasia (LGD) are typically monitored by periodic endoscopic surveillance, while those with high-grade dysplasia (HGD) and esophageal ad…

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A patient decision aid for antidepressant use in pregnancy: study protocol for a randomized controlled trial

Abstract

Background

Many women with depression experience significant difficulty making a decision about whether or not to use antidepressant medication in pregnancy. Patient decision aids (PDAs) are tools that assist patients in making complex health decisions. PDAs can reduce decision-making difficulty and lead to better treatment outcomes. We describe the methods for a pilot randomized controlled trial of an interactive web-based PDA for women who are having difficulty deciding about antidepressant drug use in pregnancy.

Methods/Design

This is a pilot randomized controlled trial that aims to assess the feasibility of a larger, multi-center efficacy study. The PDA aims to help a woman: (1) understand why an antidepressant is being recommended, (2) be knowledgeable about potential benefits and risks of treatment and non-treatment with antidepressants, and (3) be clear about which benefits and risks are most important to her, with the goal of improving confidence in her decision-making. We include women aged 18 years or older who are: (1) planning a pregnancy or are pregnant (gestational age less than 30 weeks), (2) diagnosed with major depressive disorder, (3) deciding whether or not to use a selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI) antidepressant in pregnancy, and (4) having at least moderate decision-making difficulty as per a Decisional Conflict Scale (DCS) Score ≥25. Participants are randomized to receive the PDA or an informational resource sheet via a secure website, and have access to the stated allocation until their final study follow-up. The primary outcomes of the pilot study are feasibility of recruitment and retention, acceptability of the intervention, and adherence to the trial protocol. The primary efficacy outcome is DCS score at 4 weeks post randomization, with secondary outcomes including depressive and anxiety symptoms.

Discussion

Our PDA represents a key opportunity to optimize the decision-making process for women around antidepressants in pregnancy, leading to effective decision-making and optimizing improved maternal and child outcomes related to depression in pregnancy. The electronic nature of the PDA will facilitate keeping it up-to-date, and allow for widespread dissemination after efficacy is demonstrated.

Trial registration

This trial is registered on ClinicalTrials.Gov under the identifier NCT02308592 (first registered: 2 December 2014).

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Hypoxia-Sensitive Materials for Biomedical Applications

Abstract

Hypoxia is a typical hallmark of various diseases, including cancer, ischemic diseases, and stroke. It is also associated with the disease progression. Therefore, it is critical to develop an effective strategy to target the hypoxic region for diagnosis and treatment. In this review, we summarize recent progress in the development of hypoxia-responsive systems for imaging, sensing and therapy. Two types of hypoxia-sensitive systems, the hypoxia inducible factor-1 based systems and bioreductive molecule based systems, were reviewed with comments on their advantages and limitations. Future opportunities and challenges are also discussed in the end.

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Impact of routine coronary catheterization in low extremity artery disease undergoing percutaneous transluminal angioplasty: study protocol for a multi-center randomized controlled trial

Abstract

Background

The prevalence of significant obstructive coronary artery disease with complex lesions is high in patients who have low extremity artery disease (LEAD). However, intermediate- or long-term cardiovascular prognosis of LEAD patients undergoing percutaneous transluminal angioplasty (PTA) remains poor. Accordingly, prophylactic coronary revascularization may modify short- and long-term cardiovascular outcomes of LEAD patients receiving PTA. Because myocardial ischemic symptoms are often masked in LEAD and the accuracy of non-invasive stress tests is usually limited, a high-quality randomized controlled trial aimed at the investigation of the prognostic role of coronary evaluation strategies before PTA is warranted.

Methods/Design

The proposed study is designed as a prospective, multi-center, open-label, superiority, randomized controlled trial. The study is conducted in high-volume centers for PTA and coronary revascularization in Taiwan. To meet the inclusion criteria, the patients must be at least 20 years old, have known LEAD, and have been admitted for elective PTA. We plan to enroll 450 participants who are randomly allocated to a routine group (routine coronary angiography without a previous non-invasive stress test before PTA) and a selective group (selective coronary angiography based on the results of non-invasive stress tests before PTA) with 1:1 ratio. Besides, we expect to enroll about 250 additional participants, who are not willing to be randomly assigned, in the registration group. The choice of revascularization procedure depends on the operator's or cardiovascular team's suggestion and the patient's decision. Clinical follow-up will be performed 30 days after PTA and every 6 months until the end of the 1-year follow-up for the last randomly assigned participant. The primary endpoint is the composite major adverse cardiac event on long-term follow-up. Pre-specified secondary and other endpoints are also evaluated. Those assessing biomarkers and clinical endpoints are all blinded after assignment to interventions.

Discussion

The results of the trial will, for the first time, support better decision-making for coronary evaluation before PTA in LEAD. If favorable, routine coronary angiography followed by revascularization will improve cardiovascular outcomes in LEAD patients undergoing PTA.

Trial registration

ClinicalTrials.gov identifier: NCT02169258 (registered on 21 June 2014); registry name: Routine Coronary Catheterization in Low Extremity Artery Disease Undergoing Percutaneous Transluminal Angioplasty (PIROUETTE-PTA).

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The clinical and cost effectiveness of cognitive behavioural therapy plus treatment as usual for the treatment of depression in advanced cancer (CanTalk): study protocol for a randomised controlled trial

Abstract

Background

The prevalence of depressive disorder in adults with advanced cancer is around 20 %. Although cognitive behavioural therapy (CBT) is recommended for depression and may be beneficial in depressed people with cancer, its use for depression in those with advanced disease for whom cure is not likely has not been explored.

Methods

People aged 18 years and above with advanced cancer attending General Practitioner (GP), oncology or hospice outpatients from centres across England will be screened to establish a DSM-IV diagnosis of depression. Self-referral is also accepted. Eligible consenters will be randomised to a single blind, multicentre, randomised controlled trial of the addition to treatment as usual (TAU) of up to 12 one-hour weekly sessions of manualised CBT versus TAU alone. Sessions are delivered in primary care through Increasing Access to Psychological Care (IAPT) service, and the manual includes a focus on issues for people approaching the end of life. The main outcome is the Beck Depression Inventory-II (BDI-II). Subsidiary measures include the Patient Health Questionnaire, quality of life measure EQ-5D, Satisfaction with care, Eastern Cooperative Oncology Group-Performance Status and a modified Client Service Receipt Inventory. At 90 % power, we require 240 participants to enter the trial. Data will be analysed using multi-level (hierarchical) models for data collected at baseline, 6, 12, 18 and 24 weeks. Cost effectiveness analysis will incorporate costs related to the intervention to compare overall healthcare costs and QALYs between the treatment arms. We will conduct qualitative interviews after final follow-up on patient and therapist perspectives of the therapy.

Discussion

This trial will provide data on the clinical and cost effectiveness of CBT for people with advanced cancer and depression. We shall gain an understanding of the feasibility of delivering care to this group through IAPT. Our findings will provide evidence for policy-makers, commissioners and clinicians in cancer and palliative care, and in the community.

Trial registration

Controlled Trials ISRCTN07622709, registered 15 July 2011.

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Liquid Biopsy Clinical Research – Tracking Mutations in cfDNA and CTCs

Advances in technology such as automated end-to-end solutions are allowing clinical researchers to study tough liquid biopsy samples. Leaders in the field have designed next- generation sequencing (NGS) assays that target critical questions in cancer research and tumor biology. We recently caught up with Dr. Luca Quagliata, MD, of University Hospital, Basel, Switzerland. We discussed tracking Read the rest of this article

The post Liquid Biopsy Clinical Research – Tracking Mutations in cfDNA and CTCs appeared first on Accelerating Science.

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Simulation of Front Instabilities in Density-Driven Flow, Using a Reactive Transport Model for Biogrout Combined with a Randomly Distributed Permeability Field

Abstract

Biogrout is a method to strengthen granular soil, which is based on microbial-induced carbonate precipitation. To model the Biogrout process, a reactive transport model is used. Since high flow rates are undesirable for the Biogrout process, the model equations can be solved with a standard Galerkin finite element method. The Biogrout process involves the injection of dense fluids in the subsurface. In this paper, we present our reactive transport model for Biogrout and use it to simulate an experiment in which a pulse of a dense fluid is injected in a porous medium filled with water. In this experiment, front instabilities were observed in the form of fingers. The numerical simulations showed that the fingering phenomenon was less pronounced than in the experiment. By reducing the dispersion length and implementing a randomly distributed permeability field, the fingering phenomenon could be induced. Furthermore, the results of a case study to a Biogrout application are reported.

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Evaluation of the add-on NOWAPI® medical device for remote monitoring of compliance to Continuous Positive Airway Pressure and treatment efficacy in obstructive sleep apnea

Optimizing the measurement of Continuous Positive Airway Pressure (CPAP) compliance and treatment efficacy is paramount for patients with obstructive sleep apnea syndrome (OSAS). Compliance knowledge is curren…

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Increasing diagnostic accuracy to grade dysplasia in Barrett’s esophagus using an immunohistochemical panel for CDX2, p120ctn, c-Myc and Jagged1

Patients with non-dysplastic Barrett's esophagus (ND-BE) and low-grade dysplasia (LGD) are typically monitored by periodic endoscopic surveillance, while those with high-grade dysplasia (HGD) and esophageal ad…

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A patient decision aid for antidepressant use in pregnancy: study protocol for a randomized controlled trial

Abstract

Background

Many women with depression experience significant difficulty making a decision about whether or not to use antidepressant medication in pregnancy. Patient decision aids (PDAs) are tools that assist patients in making complex health decisions. PDAs can reduce decision-making difficulty and lead to better treatment outcomes. We describe the methods for a pilot randomized controlled trial of an interactive web-based PDA for women who are having difficulty deciding about antidepressant drug use in pregnancy.

Methods/Design

This is a pilot randomized controlled trial that aims to assess the feasibility of a larger, multi-center efficacy study. The PDA aims to help a woman: (1) understand why an antidepressant is being recommended, (2) be knowledgeable about potential benefits and risks of treatment and non-treatment with antidepressants, and (3) be clear about which benefits and risks are most important to her, with the goal of improving confidence in her decision-making. We include women aged 18 years or older who are: (1) planning a pregnancy or are pregnant (gestational age less than 30 weeks), (2) diagnosed with major depressive disorder, (3) deciding whether or not to use a selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI) antidepressant in pregnancy, and (4) having at least moderate decision-making difficulty as per a Decisional Conflict Scale (DCS) Score ≥25. Participants are randomized to receive the PDA or an informational resource sheet via a secure website, and have access to the stated allocation until their final study follow-up. The primary outcomes of the pilot study are feasibility of recruitment and retention, acceptability of the intervention, and adherence to the trial protocol. The primary efficacy outcome is DCS score at 4 weeks post randomization, with secondary outcomes including depressive and anxiety symptoms.

Discussion

Our PDA represents a key opportunity to optimize the decision-making process for women around antidepressants in pregnancy, leading to effective decision-making and optimizing improved maternal and child outcomes related to depression in pregnancy. The electronic nature of the PDA will facilitate keeping it up-to-date, and allow for widespread dissemination after efficacy is demonstrated.

Trial registration

This trial is registered on ClinicalTrials.Gov under the identifier NCT02308592 (first registered: 2 December 2014).

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Hypoxia-Sensitive Materials for Biomedical Applications

Abstract

Hypoxia is a typical hallmark of various diseases, including cancer, ischemic diseases, and stroke. It is also associated with the disease progression. Therefore, it is critical to develop an effective strategy to target the hypoxic region for diagnosis and treatment. In this review, we summarize recent progress in the development of hypoxia-responsive systems for imaging, sensing and therapy. Two types of hypoxia-sensitive systems, the hypoxia inducible factor-1 based systems and bioreductive molecule based systems, were reviewed with comments on their advantages and limitations. Future opportunities and challenges are also discussed in the end.

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A prospective multicenter phase I/II clinical trial to evaluate safety and efficacy of NOVOCART Disc plus autologous disc chondrocyte transplantation in the treatment of nucleotomized and degenerative lumbar disc to avoid secondary disease: study protocol for a randomized controlled trial

Abstract

Background

Intervertebral disc degeneration is emphasized as an important cause of low back pain. Current surgical treatment provides relief to the accompanying pain and disability but does not restore the biological function of the intervertebral disc. NOVOCART™ Disc plus, an autologous cell compound for autologous disc chondrocyte transplantation, was developed to reduce the degenerative sequelae after lumbar disc surgery or to prophylactically avoid degeneration in adjacent discs.

Methods/design

This is a multicenter, randomized, controlled, clinical phase I/II combination study. A total of 120 adult patients are allocated in a ratio of 2:1:1. Sample size and power calculations were performed to detect the minimal clinically important difference of 10 units, with an expected standard deviation of 12 in the Oswestry Disability Index, which is the primary outcome parameter. Secondary outcome parameters include the visual analog scale and the EQ-5D questionnaire. Changes in physical and mental health are evaluated using the Short Form-12 (SF-12). Moreover, radiological and functional outcomes are evaluated. The major inclusion criterion is a single lumbar disc herniation that requires sequestrectomy. Transplantation is performed 90 days thereafter. Study data generation (study sites) and data storage, processing, and statistical analysis are clearly separated.

Discussion

In this phase-I/II study, NDplus is being investigated for its clinical applicability, safety, and efficacy in the repair of herniated, nucleotomized discs, and of adjacent degenerated discs, if present. To date, autologous disc chondrocytes have not been transplanted into degenerative discs without previous disc herniation. As such, this is the first study to investigate a therapeutic as well as a prophylactic approach to treat degenerative discs of the lumbar spine.

Trial registration

EudraCT No: 2010-023830-22, ID NCT01640457, 8 November 2010

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RiMINI – the influence of rifaximin on minimal hepatic encephalopathy (MHE) and on the intestinal microb iome in patients with liver cirrhosis: study protocol for a randomized controlled trial

Abstract

Background

Hepatic encephalopathy (HE) is a clinically significant complication of liver cirrhosis impacting on the patients' quality of life. Minimal hepatic encephalopathy (MHE) is diagnosed by psychometric tests, found in up to 80 % of patients with liver cirrhosis and carries a high risk of progression to overt HE. Continuous therapy with rifaximin in combination with lactulose significantly reduces the risk of overt HE, recurrence of HE and HE-related hospitalizations in randomized, double-blind, placebo-controlled clinical trials. Rifaximin is approved for the therapy of overt HE in Germany. Treatment with lactulose has been shown to improve cognitive functions in patients with liver cirrhosis. Data from prospective clinical trials comparing the efficacy of rifaximin alone against a combination of rifaximin and lactulose in the treatment of MHE are scarce. Changes in the microbiome of the upper and lower gastrointestinal tract as a result of therapy with rifaximin have not yet been addressed in clinical studies.

Methods and design

RiMINI is a monocentric exploratory pilot study on 60 patients with MHE as assessed by critical flicker frequency (CFF). Additionally, visual evoked potentials' (VEP) testing, electroencephalography (EEG) and psychometric testing (NCT-A) will be carried out. Patients will be randomized to treatment either with rifaximin alone (550 mg twice daily (bid) continuously for a period of 3 months) or with rifaximin (550 mg bid continuously) in combination with lactulose (30–60 ml daily) for 3 months. An esophagogastroduodenoscopy (EGD) will be performed at baseline, at the end of treatment and 6 and 12 weeks after the end of treatment to obtain gastric and duodenal biopsies and aspirates. The samples will be analyzed for their content of specific bacterial taxae by applying next generation sequencing (NGS) after rRNA isolation to identify the microbiome of the stomach and duodenum, and of the gut, in patients with liver cirrhosis and MHE before and after therapy.

Discussion

Differences of the effect of antibiotic therapy with rifaximin alone or in combination with lactulose on the clinical course of MHE are assessed.

Trial registration

The trial was registered as DRKS00006359 on March 17th 2015, with the universal trial number U1111-1163-9410 and with EudraCT2013-004414-18.

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Seminar Chronic pancreatitis

Chronic pancreatitis describes a wide spectrum of fibro-inflammatory disorders of the exocrine pancreas that includes calcifying, obstructive, and steroid-responsive forms. Use of the term chronic pancreatitis without qualification generally refers to calcifying chronic pancreatitis. Epidemiology is poorly defined, but incidence worldwide seems to be on the rise. Smoking, drinking alcohol, and genetic predisposition are the major risk factors for chronic calcifying pancreatitis. In this Seminar, we discuss the clinical features, diagnosis, and management of chronic calcifying pancreatitis, focusing on pain management, the role of endoscopic and surgical intervention, and the use of pancreatic enzyme-replacement therapy.

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Erratum to: ‘Novel patient engagement and recruitment strategies for an RCT of two NHS treatments for ankle osteoarthritis – total ankle replacement versus arthrodesis – the TARVA trial’

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Comment Zika virus and Guillain-Barré syndrome: another viral cause to add to the list

Zika virus was first identified in Africa in 1947, where it continues to cause regular outbreaks in sub-Saharan Africa but with very few clinical cases. In 1966, a distinct Asian lineage was found in Malaysia,1 but human disease remained uncommon in the Asia-Pacific region, despite serological surveys suggesting widespread occurrence of subclinical infections. The first recognised epidemic happened on the Micronesian island of Yap in 2007. It then spread across the Pacific to Easter Island and in 2015–16, it emerged in South and Central America and the Caribbean.

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Articles Guillain-Barré Syndrome outbreak associated with Zika virus infection in French Polynesia: a case-c ontrol study

This is the first study providing evidence for Zika virus infection causing Guillain-Barré syndrome. Because Zika virus is spreading rapidly across the Americas, at risk countries need to prepare for adequate intensive care beds capacity to manage patients with Guillain-Barré syndrome.

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The Economic Evaluation of Surgical Interventions

Alongside analyses of clinical effectiveness, economic evaluation is increasingly being used as a tool to support the adoption of new healthcare technologies, including novel endovascular techniques. Where budget constraints exist, resource allocation decisions are inevitable and an economic evaluation provides an explicit framework from which to assess the relative benefit of alternative interventions. Methods of economic evaluation differ largely in the perspective taken (i.e. cost-effective for whom?), and the measurement and valuation of outcomes.

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Seminar Guillain-Barré syndrome

Guillain-Barré syndrome is the most common and most severe acute paralytic neuropathy, with about 100 000 people developing the disorder every year worldwide. Under the umbrella term of Guillain-Barré syndrome are several recognisable variants with distinct clinical and pathological features. The severe, generalised manifestation of Guillain-Barré syndrome with respiratory failure affects 20–30% of cases. Treatment with intravenous immunoglobulin or plasma exchange is the optimal management approach, alongside supportive care.

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Cell death and neurodegeneration in the postnatal development of cerebellar vermis in normal and Reeler mice

Publication date: Available online 28 February 2016
Source:Annals of Anatomy – Anatomischer Anzeiger
Author(s): Claudia Castagna, Adalberto Merighi, Laura Lossi
Programmed cell death (PCD) was demonstrated in neurons and glia in normal brain development, plasticity, and aging, but also in neurodegeneration. (Macro)autophagy, characterized by cytoplasmic vacuolization and activation of lysosomal hydrolases, and apoptosis, typically entailing cell shrinkage, chromatin and nuclear condensation, are the two more common forms of PCD. Their underlying intracellular pathways are partly shared and neurons can die following both modalities, according to the type of death-triggering stimulus.Reelin is an extracellular protein necessary for proper neuronal migration and brain lamination. In the mutant Reeler mouse, its absence causes neuronal mispositioning, with a notable degree of cerebellar hypoplasia that was tentatively related to an increase in PCD. We have carried out an ultrastructural analysis on the occurrence and type of postnatal PCD affecting the cerebellar neurons in normal and Reeler mice. In the forming cerebellar cortex, PCD took the form of apoptosis or autophagy and mainly affected the cerebellar granule cells (CGCs). Densities of apoptotic CGCs were comparable in both mouse strains at P0-P10, while, in mutants, they increased to become significantly higher at P15. In WT mice the density of autophagic neurons did not display statistically significant differences in the time interval examined in this study, whereas it was reduced in Reeler in the P0-P10 interval, but increased at P15. Besides CGCs, the Purkinje neurons also displayed autophagic features in both WT and Reeler mice. Therefore, cerebellar neurons undergo different types of PCD and a Reelin deficiency affects the type and degree of neuronal death during postnatal development of the cerebellum.

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Air pollution source identification from odor complaint data

Abstract

We try to identify the unknown source of air pollution caused by unknown substance. We do it using only complaints on odor submitted by population living in the ∼20 × 30-km area. We test all possible locations of pollution source on the grid with 1-km spacing covering the area. For each virtual location, we perform the dispersion modeling using AERMOD with meteorological data from three nearest stations. We assume a low, ambient temperature area source with unit emission rate. The space-time array of concentrations is correlated with the analogous array of complaints, and the best correlated source position is chosen. We performed extensive experimentation with data processing options to obtain the best spatially focused correlation hotspot. This included filtering the moments of time used for correlation, quantizing the complaint numbers and concentrations, and finding the best time lag between concentrations and complaints. The best lag was 3 h in total or 1 h added to propagation time from source to receptor. The resulting focus is 1–2 km wide, positioned exactly on an active landfill. We estimate this accuracy as very good, better than warranted by the quality of source data. This demonstrates the possibility of obtaining a good focus for the location of an unknown source even from very imperfect data. The technique applied can be useful in many situations where the inventory of air pollution sources is incomplete, especially in developing countries.

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Adolescents’ Perspectives of Living With a Parent’s Cancer: A Unique and Personal Experience.

Background: By the age of 21 years, 1 in 15 children will have had a parent with a diagnosis of cancer. A parent's cancer affects the whole family. Adolescent children of cancer patients seek information about their parents' condition and support in reciprocal relations. Objective: The aims of this study were to explore adolescents' views on support and information when a parent has cancer and to describe the impact a parent's illness has on adolescents' everyday lives. Interventions/Methods: Interviews with 11 participants, conducted individually or in a focus group, were processed using qualitative content analysis. Results: Participants gained understanding about their parent's illness mainly through their experience. They looked for support primarily in their own social circles and often found their needs met. Sometimes a fear of appearing vulnerable stood in the way of asking for support and left the adolescents feeling alone. Conclusions: Participants dealt with the situation in ways that reflected their adolescence. They were connected to their parents emotionally, but strived for independence. The adolescents shared an ideal of handling difficulties on their own and looking after the people who were important to them. Implications for Practice: Making parents feel more secure in supporting their adolescent child is important. The task of balancing respect for the adolescent's integrity and providing them an opportunity to let their guard down requires trust. Inviting the adolescents to the hospital gives them a chance to learn what is happening there and to get to know healthcare personnel who may be able to help them. Copyright (C) 2016 Wolters Kluwer Health, Inc. All rights reserved

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VIVY Diathermy Pain Relief Device

Soon a new wearable may be coming to market that uses a technology called diathermy to help alleviate muscle and joint pain, as well as to help with healing and improve the benefits of physical training. The VIVY device directs short-wave radio frequencies into the target area, heating tissues from within rather than just at the surface. It's slightly reminiscent of being put inside a microwave, but the underlying technology is nothing new and has been used in a variety of settings for decades.

The VIVY wraps around the affected spot and snaps together using Velcro. Two transmitters within the interior of the band direct the RF energy at the leg, arm, or back that it's wrapped around. There will be multiple sizes of the VIVY device depending on the needs of each person.

The developers of the VIVY promise a smartphone interface and intuitive controls on the product. We'll have to see how well it works once it's available to purchase.

Though this is still a work in progress and still requires FDA clearance, the company is raising money on Indiegogo to help fund the initial production run of the VIVY.

Indiegogo campaign: VIVY: Reclaim Your Life From Pain…

The post VIVY Diathermy Pain Relief Device appeared first on Medgadget.

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Relationship between culturable airborne bacteria concentrations and ventilation systems in underground subway stations in Seoul, South Korea

Abstract

In this study, we evaluated the concentrations of culturable airborne bacteria (CABs) in the underground environment of 16 subway stations in Seoul, South Korea. The effects of environmental factors on CAB distributions and concentrations, including temperature, relative humidity, depth, year of construction, number of subway passengers, and ventilation, were investigated. Tryptone soy agar was used as the culture medium. Isolated bacteria were initially characterized according to cell morphology and Gram staining and then further characterized using the VITEK 2 XL microbial identification system. There were significant correlations between CAB concentrations and station temperature, depth, and construction year. Micrococcus and Staphylococcus species accounted for 66 % of the total number of CABs identified. CAB concentrations in stations with ventilation systems were significantly lower than those in stations without ventilation systems (p < 0.001). Thus, it is critical to develop techniques to improve indoor air quality in subway stations with no ventilation system.

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Incidence and Determinants of Port Occlusions in Cancer Outpatients: A Prospective Cohort Study.

Background: Normal saline is considered a safe alternative for heparin as a locking solution in totally implantable venous access devices. The incidence rate of partial occlusion with the use of normal saline (easy injection, impossible aspiration) is estimated at 4%. Objective: The aim of this study was to investigate determinants of partial occlusions with the use of normal saline solution and the maintenance of positive pressure in the catheter. Methods: We enrolled 218 patients with different solid tumors who underwent pharmacologic treatment through the port with different frequencies: from once every week to at least once every month. The port was flushed with normal saline solution keeping a positive pressure in the catheter. Results: We performed 4111 observations and documented normal port functioning in 99% of observations (n = 4057) and partial occlusions in 1% of observations (n = 54). Partial occlusions were significantly associated with frequency of port flushing (P

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Death Anxiety and Quality of Life in Iranian Caregivers of Patients With Cancer.

Background: Concerns about death may alienate and negatively impact communication among family members of patients with life-threatening illness. Little is known about the relationship of death anxiety to quality of life in cancer family caregivers. Objective: The aim of this study was to examine relationships between sociodemographic and patient-related factors, social support, and religiosity with death anxiety and quality of life in Iranian cancer family caregivers. Methods: Three hundred thirty family caregivers from an urban regional cancer institute in Iran participated in a descriptive-correlational study that incorporated sociodemographic surveys and validated death anxiety (Templer Scale) and Quality of life (Family Version) instruments. Results: Caregivers reported moderate levels of death anxiety and decrements in QOL. Quality of life was inversely associated with death anxiety (r = -0.30, P

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Bad splits in bilateral sagittal split osteotomy: systematic review of fracture patterns

Publication date: Available online 28 February 2016
Source:International Journal of Oral and Maxillofacial Surgery
Author(s): S.A. Steenen, A.G. Becking
An unfavourable and unanticipated pattern of the mandibular sagittal split osteotomy is generally referred to as a 'bad split'. Few restorative techniques to manage the situation have been described. In this article, a classification of reported bad split pattern types is proposed and appropriate salvage procedures to manage the different types of undesired fracture are presented. A systematic review was undertaken, yielding a total of 33 studies published between 1971 and 2015. These reported a total of 458 cases of bad splits among 19,527 sagittal ramus osteotomies in 10,271 patients. The total reported incidence of bad split was 2.3% of sagittal splits. The most frequently encountered were buccal plate fractures of the proximal segment (types 1A–F) and lingual fractures of the distal segment (types 2A and 2B). Coronoid fractures (type 3) and condylar neck fractures (type 4) have seldom been reported. The various types of bad split may require different salvage approaches.

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The new issue is now available.Journal of Information Processing and Management

Vol.58 No.12

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Correction: Structural Based Analyses of the JC Virus T-Antigen F258L Mutant Provides Evidence for DNA Dependent Conformational Changes in the C-Termini of Polyomavirus Origin Binding Domains

by Gretchen Meinke, Paul J. Phelan, Jong Shin, David Gagnon, Jacques Archambault, Andrew Bohm, Peter A. Bullock

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Influenza Virus Targets Class I MHC-Educated NK Cells for Immunoevasion

by Ahmad Bakur Mahmoud, Megan M. Tu, Andrew Wight, Haggag S. Zein, Mir Munir A. Rahim, Seung-Hwan Lee, Harman S. Sekhon, Earl G. Brown, Andrew P. Makrigiannis

The immune response to influenza virus infection comprises both innate and adaptive defenses. NK cells play an early role in the destruction of tumors and virally-infected cells. NK cells express a variety of inhibitory receptors, including those of the Ly49 family, which are functional homologs of human killer-cell immunoglobulin-like receptors (KIR). Like human KIR, Ly49 receptors inhibit NK cell-mediated lysis by binding to major histocompatibility complex class I (MHC-I) molecules that are expressed on normal cells. During NK cell maturation, the interaction of NK cell inhibitory Ly49 receptors with their MHC-I ligands results in two types of NK cells: licensed ("functional"), or unlicensed ("hypofunctional"). Despite being completely dysfunctional with regard to rejecting MHC-I-deficient cells, unlicensed NK cells represent up to half of the mature NK cell pool in rodents and humans, suggesting an alternative role for these cells in host defense. Here, we demonstrate that after influenza infection, MHC-I expression on lung epithelial cells is upregulated, and mice bearing unlicensed NK cells (Ly49-deficient NKCKD and MHC-I-deficient B2m-/- mice) survive the infection better than WT mice. Importantly, transgenic expression of an inhibitory self-MHC-I-specific Ly49 receptor in NKCKD mice restores WT influenza susceptibility, confirming a direct role for Ly49. Conversely, F(ab')2-mediated blockade of self-MHC-I-specific Ly49 inhibitory receptors protects WT mice from influenza virus infection. Mechanistically, perforin-deficient NKCKD mice succumb to influenza infection rapidly, indicating that direct cytotoxicity is necessary for unlicensed NK cell-mediated protection. Our findings demonstrate that Ly49:MHC-I interactions play a critical role in influenza virus pathogenesis. We suggest a similar role may be conserved in human KIR, and their blockade may be protective in humans.

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Immunotherapy Continues to Advance in Head and Neck Cancer

Source: http://www.onclive.com Author: Megan Garlapow, PhD Concomitant administration of motolimod with cetuximab (Erbitux) increases the innate and adaptive immune response in the blood and the tumor microenvironment in head and neck squamous cell carcinoma (HNSCC), overcoming negative prognostic biomarkers of cetuximab therapy alone, according to the biomarker data from a recent phase Ib clinical […]

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Highlights Highlights

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Patient sues over CMPAs ability to “insure” News

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Preoperative Preparation and Patient Selection for Cytoreductive Surgery and HIPEC

Abstract

Peritoneal dissemination is a significant variable affecting long term survival of abdominal cancer patients. A generally accepted clinical point of view is that peritoneal dissemination is tantamount to distant organ metastases. This implies it to be a terminal condition. Current practice dictates that if peritoneal dissemination is observed intraoperatively, the curative therapeutic options are deferred and comprehensive systemic chemotherapy remains the only option with a dismal prognosis. The past few years have generated lot of interest in management of peritoneal carcinomatosis. Prof Paul Sugarbaker has researched, validated and fine-tuned the concept of cytoreductive surgery with peritonectomy procedure (Sugarbaker technique) and perioperative chemotherapy as HIPEC & EPIC. Recognition of a HIPEC centre is based on an infrastructure equipped with basic knowledge of the tumor biology, oncosurgical techniques, technical knowhow for HIPEC administration, intensive care unit etc. There are some aspects which need to be accorded special consideration. Comprehensive therapy of Cytoreduction surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is initiated with exploration and cytoreductive surgery and includes visceral resections and peritonectomy procedure when achieved optimally results in complete, visible resection of all cancer within the abdomen and pelvis. Subsequent to CRS, HIPEC forms an integral part of the surgical procedure. This approach involves conceptual changes in both the route and timing of chemotherapy administration. Patient selection is of utmost importance. The greatest impediment to lasting benefits from intraperitoneal chemotherapy remains an improper patient selection. Currently, there are four important clinical assessments of peritoneal metastasis that need to be used to select patients ie; histopathological type of tumour, radiological distribution of disease, peritoneal cancer index and completeness of cytoreduction. Patients undergoing HIPEC surgery face the usual physiological insults of a major surgery in addition to the thermal stress secondary to intraperitoneal administration of heated chemotherapy agent. A team approach of everyone involved in care of these patients is known to improve patient outcomes. It has also been observed that with the necessary preoperative & perioperative steps, the morbidity and mortality for this treatment can be brought down as comparable to any other major abdominal surgeries.

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