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Infectious complications after cardiovascular surgery, especially in operations that use cardiopulmonary bypass (CPB), is associated with significant morbidity and increase in peri-operative mortality. Prolonged CPB usage could be predictive for early bloodstream infection following cardia surgery. This study is to analyse the demographics and microbiological factors concerning patients undergoing cardio surgical intervention using CPB complicated with bloodstream infection (BSI) postoperatively.	This study is to analyse the demographics and microbiological factors concerning patients undergoing cardio surgical intervention using CPB complicated with bloodstream infection (BSI) postoperatively.
Annually 1.5 million children and adults experience trauma to the head and brain that results in a TBI. Our research suggests that in a subset of patients, TBI induces pituitary dysfunction and abnormal growth hormone (GH) secretion. The clinical syndrome associated with abnormal GH secretion is characterized by profound fatigue and cognitive dysfunction related to executive function, short-term memory, and processing speed index. Fatigue in these patients is profound and debilitating leaving them unable to maintain their usual activity levels. We have termed this syndrome Brain Injury Associated Fatigue and Altered Cognition (BIAFAC).~Our recent work has shown that cognitive and physical dysfunction are significantly improved with recombinant human growth hormone replacement in patients with BIAFAC. Improvements in fatigue often precede (~3 months) improvements in cognition (~4-5 months) following rhGH treatment. Although rhGH replacement relieves BIAFAC symptoms, it does not cure the underlying cause, as symptoms reoccur with rhGH withdrawal.~Although the mechanisms causing BIAFAC have not been determined, our previous research demonstrated that a year of GH treatment resulted in symptom relief which was associated with changes in brain morphometry and connectivity. These associated brain changes include increased frontal cortical thickness and gray matter volume as well as resting state connectivity changes in regions associated with somatosensory networks~The next step to understanding BIAFAC is to develop a biomarker that identifies individuals that are susceptible to developing this syndrome. The University of Michigan maintains a searchable DataDirect database of over 4 million individual patient medical records linked via the Michigan Genomics Initiative (MGI) to genomic data collected from over 70,000 patients. By collaborating with the University of Michigan, we have a unique opportunity to combine their extensive genomic database with the more than 100 UTMB patients we are currently treating for BIAFAC to search for common genetic markers associated with BIAFAC. In order to identify patients in the UM genomic database with BIAFAC, we will develop a risk stratified machine-learning algorithm based on BIAFAC symptoms. Initial use of the algorithm will begin with approximately 9,000 patients in the UM database that have already been identified with a diagnosis code of fatigue and malaise. Once these patients are identified, a select cohort will be contacted to confirm the accuracy of the algorithm in identifying BIAFAC patients. Once we complete the genotyping of UTMB patients with BIAFAC and have identified the patients with BIAFAC in the UM genomic database, a genome-wide association study (GWAS) will be executed to look for common genetic markers~Aims:~Specific Aim 1: Identify patients in the UM MGI cohort who show positive traits associated with BIAFAC. Patients in the UM Michigan Genomic Initiative (MGI) cohort will be filtered through ICD-9, ICD-10, and CPT codes associated with fatigue, malaise, and other related diagnoses. Natural language processing (NLP) approaches will be developed to parse clinical notes from candidate patients, recognize relevant medical concepts, and combine features to identify candidates. These will be evaluated for algorithmic accuracy using manual review.~Specific Aim 2: Develop medical concept mapping of EHR systems across UTMB and UM. Semantic representations of medical concepts in UTMB and UM will be generated based on co-occurrence patterns of these concepts summarized from each site. Statistical methods will be developed to generate a mapping of the medical concepts between UTMB and UM and harmonize the data across institutions leveraging the trained representations. The learned mapping can facilitate the transfer of trained algorithms from one system to another.~Specific aim 3: Develop a computable phenotype to identify TBI patients with BIAFAC, combining the concept mapping identified in Aim 2 with clinical note-based features identified in Aim 1.~Specific Aim 4: Conduct genetic analysis of the UTMB cohort. The MGI cohort individuals are genotyped on an Infinium Global Screening Array and imputed to contain >10M genetic markers. We will use this data to perform a genome-wide association study (GWAS) of the phenotypes identified in Aim 3 by testing each variant for association while accounting for confounders such as population stratification.~Experimental Protocol.~The investigators will study subjects (aged 18-70 years) with a history of mild TBI (n=100).~All patients presenting with TBI and BIAFAC symptoms will be invited to participate.~TBI subjects will have saliva and possibly blood taken for DNA extraction and genotyping, which will be used for the GWAS.	The aim of this study is elucidate genetic susceptibility of patients with traumatic brain injury (TBI) and symptoms of Brain Injury Associated Fatigue and Altered Cognition (BIAFAC) using genome-wide association study (GWAS).
Currently, there is still no uniform treatment regimen in treating recurrent or metastatic nasopharyngeal carcinoma patients who failed to first-line platinum-based chemotherapy. Anti-PD-1 monoclonal antibody showed efficacy and safety in previous studies, however, the efficacy of immunotherapy alone was limited. Immunotherapy combined with other treatment regimens for recurrent or metastatic nasopharyngeal carcinoma is a strategy that needs to be urgently explored. Vascular endothelial growth factor (VEGF) is an important target in the treatment of nasopharyngeal carcinoma. Apatinib, a small-molecule tyrosine kinase inhibitor selectively inhibits vascular endothelial growth factor receptor 2 (VEGFR-2), has shown strong clinical utility. Previous clinical studies have confirmed that apatinib shows antitumor activity and tolerable toxicity in recurrent or metastatic nasopharyngeal carcinoma. Tumor vascular normalization and immune reprogramming interact synergistically and could enter a mutually reinforcing virtuous cycle by improving tumor microenvironment. The current national comprehensive cancer network (NCCN) guidelines also recommend Nivolumab and Pembrolizumab as second-line treatment for recurrent or metastatic nasopharyngeal carcinoma. More and more evidences show that immunotherapy combined with anti-angiogenesis therapy has a synergistic effect, and Camrelizumab combined with apatinib has achieved initial effect in solid tumors. Based on this, this study aims to evaluate the efficacy and safety of Camrelizumab combined with apatinib in the patients with recurrent or metastatic nasopharyngeal carcinoma who failed to first-line anti-PD-1 monoclonal antibody, to provide new evidence for individualized comprehensive treatment in nasopharyngeal carcinoma.	The purpose of this study is to explore the efficacy and safety of combination of Apatinib and Camrelizumab regimen in treating recurrent or metastatic nasopharyngeal carcinoma patients who were resistant to PD-1 antagonists.
Active controlled, randomized, double-blind, multi-center, phase 3 trial to evaluate the efficacy and safety of CKD-352 eye drops in patients with dry eye disease	The purpose of this study is to compare the efficacy and safety of CKD-352 in patients with dry eye disease
PRIMARY OBJECTIVES:~To determine the R0 resection rate of Borderline Resectable Esophageal Squamous Cell Carcinoma patients who used preoperative Sintilimab Plus Nab-paclitaxel and Cisplatin~SECONDARY OBJECTIVES:~To evaluate the Pathological Complete Response (pCR) rate, Progression Free Survival (PFS), Relapse Rate, Tumor Regression Grading (TRG) post preoperative chemotherapy, Overall Survival (OS), safety and toxicity of chemotherapy regimen and surgery.~EXPLORATORY OBJECTIVES:~Exploring the benefits of this treatment strategy in Borderline Resectable Esophageal Squamous Cell Carcinoma patients at a molecular level~OUTLINE:~Eligible patients receive Sintilimab and cisplatin intravenously on day 1 and albumin-bound paclitaxel intravenously on days 1 and 8. This cycle is repeated every 3 weeks in the absence of disease progression or unacceptable toxicity. Radiological and multidisciplinary assessment is performed after every 2-4 cycles.	An open-label, non-randomized, phase II study to assess the safety and efficacy of Preoperative Sintilimab Plus Nab-paclitaxel and Cisplatin in Borderline Resectable Esophageal Squamous Cell Carcinoma patients
This is a phase III, non-inferiority double-blinded, randomized, controlled trial of immunogenicity with two groups of participants who will received a seasonal trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2 and B) or an active comparator (licensed influenza vaccine).~A total of about 816 healthy Thai male and female adult volunteers ≥ 65 years of age; 408 participants will be randomized to receive the GPO Tri Fluvac and 408 will receive an active comparator (a 1:1 ratio).	The study is aim to evaluate the Immunogenicity with two groups of participants who will received a seasonal trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2 and B) or an active comparator (licensed influenza vaccine).
The goal of the study is to examine whether a shared decision making intervention improves decision making about colon cancer screening for patients who had their colonoscopy delayed or postponed due to the COVID pandemic. Eligible patient (n=800) will randomly assigned to either the intervention or control arm. A subset will be surveyed about 6-8 weeks post intervention to determine the extent to which they report shared decision making, their intention to follow through with screening, and their decisional conflict. Study staff will also conduct medical chart review to track receipt of colon cancer screening within 6 months.~Intervention arm: In this arm, patients will get a shared decision making information sheet in the mail that describes three screening options: (1) schedule next available colonoscopy, (2) switch to a stool-based test, and (3) delay colonoscopy for a year. Study staff trained in decision coaching will follow up with patients to help them select an option and support implementation.~Control arm: This arm will be a usual care arm. The gastroenterology department department has schedulers calling patients and texting patients to schedule their procedure.~All 800 patients will be followed for their cancer screening outcomes, and a subset n=460 or 230 in each arm will be randomly selected to receive the survey.~Study staff who prepare the intervention mailing and the surveys will not be blinded to the study arm. The staff who enter the data from the paper surveys and who conduct chart review to collect screening will be blinded to the assignment. The statistician analyzing the results will also be blinded to the assignment.~The following hypotheses will be evaluated using an intention to treat approach, so patients will be analyzed based on their assigned arm.~Hypothesis 1: Compared to the control group, patients in intervention arm will report higher shared decision making (primary outcome).~Hypothesis 2: Compared to the control group, patients in the intervention arm will have (2a) stronger intention to follow through with colon cancer screening (whether colonoscopy, stool-based test or other approach) and (2b) will be more likely to have a screening test within 6 months.~Hypothesis 3: Compared to the control group, patients in the intervention arm will have less decisional conflict (SURE score).	The goal of the study is to examine whether a shared decision making intervention improves decision making about colon cancer screening for patients who had their colonoscopy delayed or postponed due to the COVID pandemic. Eligible patients (n=800) will be randomly assigned to either the intervention or control arm. A subset will be surveyed about 6-8 weeks post intervention to measure shared decision making, their intention to follow through with screening, and their decisional conflict. Study staff will conduct medical chart review to track receipt of colon cancer screening within 6 months. The statistician will test whether patients in the intervention arm report more shared decision making, less decisional conflict, higher intention to follow through on screening and have higher screening rates compared to those in the control arm.
In this study, the investigators aim to understand the role of transcranial direct current stimulation (tDCS) in modulating aberrant neurocognitive processes implicated in pediatric patients with obsessive compulsive disorder (OCD). The investigators propose two arms of the study that will investigate fear extinction learning and inhibitory control in one arm (A), and goal orientated versus habit-based behavior and inhibitory control in the other (B). All subjects will undergo three study conditions: two with active tDCS to each of two different brain targets and one under sham tDCS. The order of stimulation (sham or active tDCS) will be randomized.	In this study, the investigators aim to understand the role of transcranial direct current stimulation (tDCS) in modulating aberrant neurocognitive processes implicated in pediatric patients with obsessive compulsive disorder (OCD).
This study is an extension of previous clinical trials (NCT00308997 and NCT00567281) that were initiated in 2006. This study record provides the results for the amended study NCT00567281 (originally called a 'third arm') that was discontinued following the passing of Dr. Ralph Hoffman. The primary purpose of the study was to conduct fMRI neuroimaging studies prior to and subsequent to the rTMS intervention. The intent was to ascertain changes in regional brain activation and connectivity that most robustly predict level of improvement in auditory hallucinations elicited by bilateral rTMS as assessed by our primary outcome variables. It was hoped that this combined fMRI/rTMS study would provide critical new insights into the neurobiological basis of auditory hallucinations.~The results presented are what was summarized following Dr. Hoffman's passing and were compiled by Dr. Philip Corlett.	The primary purpose of this study was to conduct fMRI neuroimaging studies prior to and subsequent to the rTMS intervention. The intent was to ascertain changes in regional brain activation and connectivity that most robustly predict level of improvement in auditory hallucinations elicited by bilateral rTMS as assessed by the primary outcome variables.
The study is to investigate the safety, tolerability, efficacy and pharmacokinetics of liposomal mitoxantrone hydrochloride in combination with Cyclophosphamide, Vincristine and Prednisone in the frontline treatment of patients with PTCL by conducting in two stages, Dose-finding stage and Dose-expansion stage.In Dose-finding stage, patients with treatment-naïve PTCL will be assigned to receive sequentially higher doses of liposomal mitoxantrone hydrochloride ranging from 12 to 18 mg/m2 plus Cyclophosphamide, Vincristine and Prednisone (28 days per cycle). The dose escalation will follow the classic 3+3 design. The recommended Phase 2 dose (RP2D) of liposomal mitoxantrone hydrochloride will be determined according to the Dose-finding results. In Dose-expansion stage, additional patients will be recruited into two groups, the Q4W group（28 days per cycle）and the Q3W group（21 days per cycle）, to receive liposomal mitoxantrone hydrochloride at the RP2D combined with Cyclophosphamide, Vincristine and Prednisone. All patients will receive the treatment for the planned 6 cycles or until disease progression or unacceptable drug-related adverse events.	This is a multicentre, open-label, single-arm, phase Ib clinical study to evaluate the safety, tolerability, efficacy and pharmacokinetics of liposomal mitoxantrone hydrochloride in combination with Cyclophosphamide, Vincristine and Prednisone in the frontline treatment of patients with peripheral T cell lymphoma (PTCL).
This study is an open label Phase 1 study evaluating the safety, pharmacokinetics, and pharmacodynamics of a single dose of CDX-0159 in patients with Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria who remain symptomatic despite treatment with antihistamines. Twenty patients with Cold Contact Urticaria, ten patients with Symptomatic Dermographism, and ten patients with Cholinergic Urticaria will be enrolled in four separate cohorts for a total of 40 patients.~Prospective patients will be screened with tests in clinic as well as daily at home diaries for 2 weeks prior to enrollment. CDX-0159 will be administered intravenously on Day 1. Post-treatment, patients will be followed for 12 weeks with an optional longer term follow up period.	This is a study to determine the safety of CDX-0159 in patients with Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria.
Since December 2019, the COVID-19 pandemic has widespread from China and put under strong tension the health organizations throughout the world, especially since march 2020 in France.~As a consequence, the French hospitals had to cope with a massive amount of COVID-19 infected patients and, thus, their organisations had to evolve in order to be able to admit more patients in their critical care units.~First studies reported an important level of inter-human contagiousness of the SARS-CoV-2 virus with an R0 (basic reproduction number) superior to 3, which could lead to a massive contamination of healthcare workers since they are directly in charge of infected patients.~Other studies suggested that the healthcare workers are more likely to be contaminated by the COVID-19 than the rest of the population, which pushed governments and hospital managers to put in place individual and collective measures of protection in order to avoid nosocomial transmissions and also to preserve the health of the hospital staffs in a context of high tension on the hospital work force.~There are today few data about the contamination level among the healthcare workers of general hospitals in France and about the severity of these contaminations. A national study is being conducted but on a macroscopic regional scale. In addition to that, the proportion of asymptomatic SARS-CoV-2 contaminated healthcare workers is not known as well as the origin (hospital or community) of the contaminations.~In June 2020, the French Health Ministry decided to launch a collection of epidemiological data in the French hospitals based on serologic tests. Thanks to this action and with the results of all the RT PCR tests systematically conducted since the beginning of the pandemic when a healthcare worker had COVID-19-like symptoms, the Centre Hospitalier Sud Essonne has decided to conduct an observational study.~The aim of this study is to evaluate the prevalence of COVID-19 among the workers of our hospital and the factors that are likely to influence this prevalence. It must be underlined that our hospital is settled in two towns and both hospital sites had different missions regarding the admissions of COVID-19-infected patients.	The aim of this study is to evaluate the prevalence of COVID-19 among the workers of our hospital and the factors that are likely to influence this prevalence. It must be underlined that our hospital is settled in two towns and both hospital sites had different missions regarding the admissions of COVID-19-infected patients.
JTX-4014 is a fully human IgG4 monoclonal antibody designed to specifically bind to PD-1 and block its interaction with its ligands, PD-L1 and PD-L2, to augment anti-tumor T cell activity. Vopratelimab is an agonist monoclonal antibody that specifically binds to the Inducible CO-Stimulator of T cells (ICOS) to generate an anti-tumor immune response. This is a Phase 2, open label study to evaluate the efficacy, safety, tolerability of JTX-4014 alone and in combination with vopratelimab in biomarker-selected adult subjects with metastatic NSCLC who are PD-1/PD-L1 inhibitor naïve and have progressed on a platinum based chemotherapy regimen	This is a Phase 2, open-label study to evaluate PD-1 inhibitor JTX-4014 alone and in combination with vopratelimab, an ICOS agonist, in biomarker-selected adult subjects with metastatic NSCLC who are PD-1/PD-L1 inhibitor naïve and have progressed on a platinum based chemotherapy regimen.
The long-term goal of this research is to reduce morbidity and improve HF self-care by enhancing family problem-solving and collaborative care management among rural HF dyads. The initial step in meeting this goal is to develop and pilot-test a culturally-sensitive, telephone-based, tailored dyadic problem-solving intervention to improve HF self-care in rural HF dyads. Using a multi-phase, sequential qualitative and quantitative approach, the following research aims are to: 1) identify the major dyadic HF-related problems dyads experience and how these problems are managed; 2) develop a telephone-based, tailored dyadic problem-solving intervention and determine its feasibility and acceptability for managing HF-related problems; and 3) evaluate the preliminary effects of the telephone-based, tailored dyadic problem-solving intervention on dyadic problem-solving and patient and family caregiver contributions to HF self-care. As an exploratory aim, we will also evaluate the effectiveness of the dyadic problem-solving intervention on caregiver burden, self-care, and life changes. In Phase I, qualitative inquiry will guide in-depth semi-structured dyad interviews (n = 12-20 dyads; 24-40 participants) to identify the dyadic HF-related problems experienced by rural HF dyads and associated management strategies (Aim 1). Phase II will be guided by qualitative and quantitative methods and include a repeated measures, single-group design to evaluate the feasibility, acceptability, and preliminary effectiveness of the 12-week dyadic problem-solving intervention in a sample of rural HF dyads (n = 60 dyads; 120 participants) (Aims 2, 3). Participants for this study will be recruited from from the Florida State University Institute for Successful Longevity Participant Registry, outpatient HF/cardiac and rural healthcare clinics affiliated with Tallahassee Memorial Hospital, Bond Community Health Clinic, via social medial and newspaper ads, and publicly available community sites (e.g., senior centers, post offices, grocery stores, etc.).~Phase I (Arm 1) will identify dyadic HF-related problems and management strategies using semi-structured interviews in a sample of rural-residing HF dyads (n = 12-20 dyads; 24-40 participants). Following consent, interviews will occur once and be approximately 45 minutes long. Qualitative data from Phase I will be analyzed using thematic analytic methods and NVivo11. Information gained in Phase I will be used to develop the telephone-based, tailored, dyadic problem-solving intervention for rural HF dyads tested in Phase II.~Phase II (Arm II) will be guided by qualitative and quantitative inquiry and include a single-group, repeated measures design with time and dyad-member as within-subject factors. A sample size of 60 dyads (120 participants) is desired based on a power analysis for repeated measures ANOVA with 4 time points, alpha level of .05, a medium effect size (f = 0.25), and 80% power, plus oversampling for potential attrition (20%). Following verbal informed consent via telephone, all dyads will be screened for cognitive impairment using the Telephone Interview for Cognitive Status (TICS) prior to baseline data collection, which will include a Sociodemographic and Clinical Survey, the Self-Care of HF Index (SCHFI; v. 6.2) (patients only), the Caregiver Contribution to the Self-Care of HF Index (CCSCHFI) (caregivers only), Healthcare Utilization Survey, the Social Problem-Solving Inventory Revised-Short (SPSIRS), the Center for Epidemiological Studies-Depression (CESD), the Global Family Function Subscale (GFF) of the Family Assessment Device Questionnaire, and the Interpersonal Support Evaluation List-12 (ISEL-12). Caregivers will also complete the Dutch Objective Burden Inventory (DOBI), Denyes Self-care Practice Instrument (DENYES), and the BAKAS Caregiving Outcomes Scale (BAKAS).~Using a single group design, all dyads will participate in a problem-solving training intervention over 12 weeks (Weeks 1-4, 6, 8, 10, 12), with follow-up data collection occurring at weeks 5, 9, 11, 13. Qualitative data will be collected at weeks 5 and 11 via semi-structured interviews with dyads. Quantitative data on study outcomes and covariates will be collected at weeks 5, 9, and 13 and consist of the SCHFI (patient), CCSCHFI (caregiver), healthcare utilization (patient), SPSIRS (dyad), REALM (dyad), CESD (dyad), GFF (dyad),ISEL-12 (dyad), DOBI (caregiver), Denyes (caregiver) and the BAKAS (caregiver). All data will be self-report and collected by a trained research assistant who will collect study data over the telephone and mark participants answers on a computerized data spreadsheet. Qualitative data will be analyzed using thematic analytic methods and NVivo11. Possible treatment effectiveness on dyadic problem-solving, patient and caregiver contributions to HF self-care, healthcare utilization, caregiver burden, caregiver self-care, caregiver life changes, and differences among subgroups (gender, relationship type) over the 13 weeks will be examined using multilevel modeling and dyadic Growth Curve Modeling (GCM).	This study will develop and test the effectiveness of a culturally-sensitive, telephone-based, tailored dyadic problem-solving intervention to improve self-care in rural heart failure (HF) dyads. The target population is rural-residing HF dyads (patient and family caregiver). Rural dyads will be recruited from the Florida State University Institute for Successful Longevity Participant Registry, outpatient HF/cardiac and rural healthcare clinics affiliated with the Tallahassee Memorial Hospital, Bond Community Health Clinic, via social medial and newspaper ads, and publicly available community sites (e.g., senior centers, post offices, grocery stores, etc.). Phase I (Arm I) will include a one-time telephone-based semi-structured interview. Dyads in Phase II (Arm II) will receive one telehealth (virtual or telephone) session, followed by 7 follow-up telephone sessions.
The study is a randomized crossover trial testing the feasibility and safety of three different training protocols in 10 COVID-19 survivors that have been discharged from hospital. The subjects will be randomized to perform three different exercise training protocols in a random order.~The aim is to clarify the feasibility and safety of three training protocols in COVID-19 survivors. The hypothesis is that patients surviving COVID-19 will be able to comply to all training protocols.~The study consists of 4 visits with 1 baseline session (a medical screening and fitness test) and 3 different training sessions. Each training is separated by 1-week washout, to account for potential confounding by leisure activity performed just before the training, patients will be wearing activity watches (Polar).~Feasibility and safety evaluation will be based on 1) how tolerable and enjoyable the training was based on a subjective questionnaire (Likert Scale) 2) compliance to the prescribed exercise protocol with regard to duration and intensity and 3) experienced side effects.	This current protocol encompasses an investigator-blinded randomized exercise intervention in 10 COVID-19 survivors that have been discharged from hospital. The subjects will be randomized to perform three different exercise training protocols in a random order.~The aim is to clarify the feasibility and safety of three training protocols in COVID-19 survivors. The hypothesis is that patients surviving COVID-19 will be able to comply to all training protocols.
The purpose of this study is to compare the Vivaer procedure for treatment of nasal airway obstruction (NAO) with a sham procedure that simulates the actual procedure as closely as possible absent the delivery of radiofrequency (RF) energy to the nasal tissue.	The purpose of this study is to compare the Vivaer procedure with radiofrequency (RF) energy to sham procedure for treatment of nasal airway obstruction (NAO).
BACKGROUND Breast cancer (BrCa) is the most common malignant neoplasm in women worldwide with a continuous rise on both its incidence and cancer-related deaths (1-3). Accurate evaluation of the presence, extent and status of axillary lymph nodes (ALNs) in patients with BrCa has an important prognostic value, and is essential for disease staging and treatment planning (4).~Historically, axillary lymph node dissection (ALND) and histopathology was used for staging BrCa, but with inevitable short- and long-term complications such as lymphedema, nerve injury, seroma and infection (5). Afterwards, sentinel lymph node (SLN) biopsy (SLNB) has gradually replaced ALND despite its invasive nature, unavoidable false negative results and post-operative complication, which are far less than those encountered with ALND (6). According to the American Society of Oncology Guidelines, If the SLNB results are negative, no further dissection is done because there is no survival benefit for performing ALND in this setting. Patients with positive SLNB results traditionally undergo completion ALND (6,7)~Grey-scale ultrasound (US) is a non-invasive method that plays an important role in the preoperative evaluation of ALNs and obtaining samples in patients with BrCa (8-11). Nevertheless, US is operator dependent and focuses mainly on the morphological features lymph nodes (LNs). Addition of Color-Doppler Ultrasound (CDU helps in assessing the presence and distribution of vasculature pattern as well as the resistive index (RI) of ALNs (11-13). Despite their promising results, US and CDU, studies showed very wide ranges and variations in sensitivity and specificity (8-13).~Real-time strain ultrasound elastography (UE) is an imaging technique that utilizes the long-established clinical concept that malignant lesions are often stiffer than normal tissues. The stiffness, a characteristic that can't be assessed by US nor CDU (14) and the UE has therefore been utilized to assess pathological changes in many organs, such as liver, breast, thyroid, muscle, Kidney, Prostate, and cervical LNs (Nicely reviewed in 14). Additionally, elastograms obtained by UE are color-coded images indicating differences in stiffness of portions of a target tissue. These color maps or images arise from analysis of the changes in the radiofrequency impulses before and after the rhythmic manual compression directed along the radiation axis. In addition, UE images are produced simultaneously with the conventional gray-scale US to ensure that images of the same node are precisely obtained (14). UE has also been used in assessing ALNs, but with variable and conflicting results (15,16). Two recent meta-analyses concluded that UE can provide additive useful information regarding ALN assessment prior to surgical procedure selection (17,18).~Other imaging modalities such as mammography, magnetic resonance imaging (MRI), multi-detector computed tomography (CT), Positron-emission tomography (PET-CT) were also tried, but their wide use is limited by their moderate sensitivity, low specificity, need for special protocol for ALNs assessment, law availability, high cost and radiation hazard (19-25).~Multimodal imaging combines two or more imaging modalities into one system to produce details in clinical diagnostic imaging that are more precise than any conventional imaging alone.~AIMS The present study is designed to assess the role of simultaneous multi-modal sonographic tools (US, CDU, UE) in evaluating the nature (benign or malignant) of ipsilateral ALNs in patients with primary BrCa together with comparing the diagnostic indices of each with that of all-together (combined modalities). In other words, whether adding UE to conventional grey-scale US and CDU will increase their diagnostic accuracy or not.~METHODS A: Type of the study: A prospective cohort diagnostic hospital-based study B: Study Setting: Department of Diagnostic Radiology, Assiut University Hospitals.~C: Sample Size Calculation: The study will include 30 consecutive patients with primary BrCa and ipsilateral ALNs of obscure nature visible by axillary conventional/grey-scale ultrasound (US) scan. In Each patient, one or more LN may be examined.~D: Study tools: All participants will be subjected to the following:~I. Screening clinical physical and Grey-scale ultrasound examination of the axilla With patients in the supine position, an experienced radiologist in conventional US, CDU, UE will perform the physical clinical examination using a Gray-scale digital US scanner (General Electric (GE, USA), equipped with a 7.5-13 MHz liner transducer will be performed first to assess for the presence of ALNs. Only the ipsilateral axillary region will be evaluated.~II. Conventional (grey-scale) ultrasound (US) Scoring of the ALNs A gray-scale conventional US scoring system of 5 criteria will be implemented. These include 1) Short-axis (S) diameter (S >7 mm = score 1; S ≤7 mm = score 0), 2) Long-to-short axis (L/S) diameter ratio (L/S; <2 = score 1; ≥ 2 = score 0), 3) The hilum long axis-to-node long axis (H/L) diameter ratio (H/L <0.5 = score 1; H/L ≥ 0.5 = score 0). 4) Border (irregular = score 1; regular =score 0), and 5) Cortical thickness (T >3 mm = score 1; T ≤ 3 mm = score 0). When the node did not have a hilar region, the cortical thickness will be regarded as ≥ 3 mm when the short-axis diameter is >3 mm (26) and Figure 2.~III. Color Doppler Ultrasound (CDU) examination of the ALNs After US, CDU will be performed as previously described (11-13) with the following precautions: 1) use of low wall filter and low velocity scale to be able to detect slow flow. 2) adjust color gain to maximum to help better blood flow demonstration and avoid noise artefacts. 3) place the transducer gently to avoid superficial vessels compression that may lead to an increase in vascular resistance. Intra-nodal blood flow in color Doppler studies will be classified into 4 categories: 1) central flow; 2) peripheral flow; or 3) Mixed peripheral and central, 4) absent flow. Central vessels are those appearing in both hilar and peri-hilar branches only. Peripheral vessels are those in the periphery that have no connection with the hilar vessel. Lymph nodes with both peripheral and central (mixed) flow will be grouped as mixed. If blood vessels are detected, 3 Doppler spectral waveforms will be obtained, and their mean will be calculated and considered as the resistivity index (RI). The RI is chosen as it is not dependent on the angle of insonation, and therefore, it can be accurately calculated even in small vessels. RI is calculated as follows: RI = Peak systolic velocity - end diastolic velocity/peak systolic velocity~IV. Strain ultrasound elastography (UE) of the ALNs UE images will be evaluated with a scoring system based on the percentage and distribution of the hypoechoic cortex regions with a visible hilum in ALN (Pattern I) or all the hypoechoic lymph nodes with an absent hilum (Pattern II).~In Pattern I (LN with Hila), scoring will be as follows (26):~the green portion occupied almost all of the cortex;~the blue portion occupies <50% of the cortex;~the blue portion occupies >50% of the cortex, with scattered the green portions;~the blue portion occupies almost all of the cortex;~the blue portion occupies almost all of the cortex, with a green ring on the edge of the node.~In pattern II (LN without Hila), scoring will be as follows (26):~Green portion occupying almost all of the cortex.~Blue portion occupying less than 50% of the cortex.~Blue portion occupying more than 50% of the cortex, with a scattered green portion~Blue portion occupying almost all of the cortex.~Blue portion occupying almost all of the cortex, with a green ring on the edge of the node.~Calculation of the Strain Ratio (SR) by UE. The SR is a ratio between the strain value of the two regions of interest (ROI) A and B, where ROI-A is the deepest blue portions of the hypoechoic regions within the nodes, and ROI-B is the surrounding soft and adipose tissue at the same depth.~(SR = strain value of ROI-B / strain value of ROI-A) Of note, SR is automatically calculated by the software built into certain equipment and displayed on its monitor (26).~V. Combined evaluation of gray-scale US, CDU and UE. The score of combined evaluation for each lymph node will be the sum of the gray-scale US (5 points), the CDU (1 point), and the UE (5 points) scores. A cut-off value will be evaluated with the pathological diagnosis.~VI. Ultrasound-guided FNA from the ALNs After completion of the above 3 sonographic modalities' examinations, and under local anesthesia using 5 ml of subcutaneous 1% Xylocaine, US-guided fine needle aspiration (FNA) will be performed by the same radiologist for all visible ALNs using 20-22 gauge needles attached to a 10 ml plastic syringe. Under UE guidance, the needle will be inserted into the cortex with 3 passes as routinely performed and previously described (27). When 2 or more abnormal LNs are identified, the node that looks the most suspicious will be aspirated. Samples will then be spread and fixed on glass-slides using 95% alcohol and air-dried for Pap & Diff-Quik (American Scientiﬁc Products, McGraw Park, IL, USA) staining in the Pathology Department prior to being examined. The final pathological diagnosis for the LNs will be made by a pathologist blinded to the imaging findings. Results of the US modalities will be correlated with the results of the FNAC.~E: Data Management and Statistical Analyses Data collection will be done in a preformed Data Collection Form (Appendix 1) prior to being entered in Microsoft Exel 2016. Afterwards, data will be exported to the Statistical Package for Social Sciences (SPSS) version 23.0 software package (SPSS, Inc., Chicago, IL, USA) for the statistical analysis. Comparisons of numeric (continuous) variables and categorical variables will be done using the Wilcoxon's rank sum test or Student's t-test and Chi-Square or Fisher's Exact test respectively and as appropriate. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy will be calculated to compare the diagnostic performance of each modality. The areas under the receiver operating characteristic (ROC) curves (AUC) will be calculated and compared using the U-test. All cutoff values will be determined depending on the best accuracy identified by ROC curves. A probability value of (P<0.05) will be considered Statistically significant for all tests. The cytopathological diagnosis will be considered as the reference gold standard.~REFERENCES~Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019;69(1):7-34.~DeSantis CE, Ma J, Gaudet MM, et al. Breast cancer statistics, 2019. CA Cancer J Clin. 2019;69(6):438-451.~Bray F, Ferlay J, Soerjomataram I, et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2018;68:394-424.~Kleer CG, Sabel MS. Prognostic and predictive factors in breast cancer. In: Kuerer HM, ed. Kuerer's breast surgical oncology. New York, NY: McGrawHill, 2010; 244.~Ivens D, Hoe AL, Podd TJ, et al. Assessment of morbidity from complete axillary dissection. Br J Cancer 1992;66:136-138.~Lyman GH, Giuliano AE, Somerfield MR, et al. American Society of Clinical Oncology guideline recommendations for sentinel lymph node biopsy in early-stage breast cancer. J Clin Oncol. 2005;23(30):7703-7720.~Krag DN, Anderson SJ, Julian TB, et al. Technical outcomes of sentinel-lymph-node resection and conventional axillary-lymph-node dissection in patients with clinically node-negative breast cancer: results from the NSABP B-32 randomised phase III trial. Lancet Oncol 2007;8:881-888.~Britton, PD, Meroni S, Moscovici OC, et al. Use of ultrasound-guided axillary node core biopsy in staging of early breast cancer. Eur Radiol 2009;19:561-569.~Choi YJ, Ko EY, Han BK, et al. High-resolution ultrasonographic features of axillary lymph node metastasis in patients with breast cancer. Breast 2009;18:119-122.~Alvarez S, Añorbe E, Alcorta P, et al. Role of sonography in the diagnosis of axillary lymph node metastases in breast cancer: a systematic review. Am J Roentgenol 2006;186:1342-1348.~Choudhary J, Agrawal R, Mishra A, Nandwani R. Ultrasound and color Doppler evaluation of axillary lymph nodes in breast carcinoma with histopathological Correlation. Int J Scientific Study 2018;5(10):59-66.~Esen G, Gurses B, Yilmaz MH, et al. Gray scale and power Doppler US in the preoperative evaluation of axillary metastases in breast cancer patients with no palpable lymph nodes. Eur Radiol. 2005;15(6):1215-1223.~Esen G. Ultrasound of superficial lymph nodes. Eur J Radiol. 2006;58(3):345-359.~Sigrist RMS, Liau J, El Kaffas A, et al. Ultrasound Elastography: Review of Techniques and Clinical Applications. Theranostics 2017; 7:1303-1329.~Tsai WC, Lin CK, Wei HK, et al. Sonographic elastography improves the sensitivity and specificity of axilla sampling in breast cancer: a prospective study. Ultrasound Med Biol 2013;39:941-949.~Park YM, Fornage BD, Benveniste AP, et al. Strain elastography of abnormal axillary nodes in breast cancer patients does not improve diagnostic accuracy compared with conventional ultrasound alone. AJR Am J Roentgenol 2014;203(6):1371-1378.~Wang RY, Zhang YW, Gao ZM, Wang XM. Role of sonoelastography in assessment of axillary lymph nodes in breast cancer: a systematic review and meta-analysis. Clin Radiol 2020;75:320.e1-320.e7.~Tang GX, Xiao XY, Xu XL, et al. Diagnostic value of ultrasound elastography for differentiation of benign and malignant axillary lymph nodes: a meta-analysis. Clin Radiol 2020;75:481.e9-481.e16.~Valente SA, Levine GM, Silverstein MJ, et al. Accuracy of predicting axillary lymph node positivity by physical examination, mammography, ultrasonography, and magnetic resonance imaging. Ann Surg Oncol 2012;19:1825-1830.~Kim WH, Kim HJ, Lee SM, et al. Preoperative axillary nodal staging with ultrasound and magnetic resonance imaging: predictive values of quantitative and semantic features. Br J Radiol. 2018;91(1092):20180507.~Felipe VC, Graziano L, Barbosa PNVP, et al. Multidetector Computed Tomography with Dedicated Protocol for Breast Cancer Locoregional Staging: Feasibility Study. Diagnostics (Basel). 2020;10(7):479.~Liang X, Yu J, Wen B, et al. MRI and FDG-PET/CT based assessment of axillary lymph node metastasis in early breast cancer: a meta-analysis. Clin Radiol. 2017;72(4):295-301~Zhang X, Liu Y, Luo H, Zhang J. PET/CT and MRI for Identifying Axillary Lymph Node Metastases in Breast Cancer Patients: Systematic Review and Meta-Analysis [published online ahead of print, 2020 Jun 21]. J Magn Reson Imaging. 2020;10.1002/jmri.27246.~Marino MA, Avendano D, Zapata P, et al. Lymph node imaging in patients with primary breast cancer: concurrent diagnostic tools. The Oncologist 2020;25:e231-e242.~Lowes S, Leaver A, Cox K, et al. Evolving imaging techniques for staging axillary lymph nodes in breast cancer. Clin Radiol. 2018;73(4):396-409.~Xu Y, Bai X, Chen Y, et al. Application of Real-time Elastography Ultrasound in the Diagnosis of Axillary Lymph Node Metastasis in Breast Cancer Patients. Sci Rep. 2018;8(1):10234.~Krishnamurthy S, Sneige N, Bedi DG, et al. Role of ultrasound-guided fine-needle aspiration of indeterminate and suspicious axillary lymph nodes in the initial staging of breast carcinoma. Cancer. 2002;95(5):982-988.~https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/(Last seen on 25,8,2020).	Breast cancer (BrCa) is the most common malignant neoplasm in women worldwide with a continuous rise on both its incidence and cancer-related deaths. Accurate evaluation of the presence, extent and status (benign or malignant) of axillary lymph nodes (ALNs) in patients with BrCa has an important prognostic value, and is essential for disease staging and treatment planning. Many radiological diagnostic modalities have been utilized to assess the nature of ALNs in the pre-operative stage. Each modality has its weaknesses and strengths. Multimodal imaging combines two or more imaging modalities into one system to produce details in clinical diagnostic imaging that are more precise than any conventional imaging alone. Therefore, the present study is designed to assess the role of simultaneous multi-modal sonographic tools [conventional grey-scale ultrasound; US, Color-Doppler ultrasound; CDU, strain ultrasound elastography; UE) in evaluating the nature (benign or malignant) of ipsilateral ALNs in patients with primary BrCa together with comparing the diagnostic indices of each with that of all-together (combined modalities). A total of 30 patients with BrCa and US-visible ALNs will be included. All will be subjected to simultaneous examination by US, CDU, UE and US-guided FNA cytology examination of their ipsilateral ALNs. Data will be collected and analyzed using SPSS version 23. Area under the receiver Operating Characteristic (ROC) curve will be calculated and the diagnostic indices of each modality and of all modalities will be measured.
Approximately 330 CKD patients on dialysis with hyperphosphatemia (>4.5 mg/dL) will be enrolled in this study.~This is a randomized, open-label study to evaluate different methods of initiating tenapanor therapy in CKD patients on dialysis with hyperphosphatemia, when they are either phosphate binder naïve or on phosphate binder therapy.~The study consists of a Screening visit and a 10-week open-label Treatment Period (TP), for which~Patients with s-P >5.5 and ≤10.0 mg/dL under stable phosphate binder treatment are randomized in a 1:1 ratio to two different treatment cohorts:~Cohort 1 (straight switch), which stops taking phosphate binders and is started on tenapanor 30 mg twice daily (BID) at Visit 2 (Day 1);~Cohort 2, which decreases phosphate binder dose by at least 50% (may be more than 50% if patient is taking an odd number of binder pills each day), with ability to switch the binder regimen from thrice daily (TID) to BID or QD; and initiates tenapanor 30 mg BID at Visit 2 (Day 1).~Phosphate binder naïve patients with s-P >4.5 and ≤10.0 mg/dL are enrolled as Cohort 3 and receive tenapanor at Visit 2 (Day 1) with a starting dose of 30 mg BID.~Patients on phosphate binder therapy must receive phosphate binder(s) thrice daily, and both the s-P level assessed at the most recent measurement prior to the Screening visit (Visit 1) and the s-P level assessed at the Screening visit (Visit 1) must be >5.5 and ≤10.0 mg/dL to qualify for randomization into Cohort 1 or Cohort 2 at Visit 2 (Day 1).~Phosphate binder naïve patients must have the s-P level assessed at the Screening visit (Visit 1) >4.5 and ≤10.0 mg/dL to qualify for enrollment into Cohort 3 at Visit 2 (Day 1).~Patients who do not meet the randomization/enrollment criteria on s-P will be discontinued as screen failures.~During the TP, patients will receive tenapanor starting at a dose of 30 mg twice daily. Tenapanor will be taken twice daily; just prior to breakfast and dinner. The Investigator may titrate the dose of tenapanor in 10 mg increments down to a minimum of 10 mg QD or up to a maximum of 30 mg BID at any time during the study based on s-P levels and/or gastrointestinal (GI) tolerability.	This is a randomized, open-label study to evaluate different methods of initiating tenapanor therapy in CKD patients on dialysis with hyperphosphatemia, when they are either phosphate binder naïve or on phosphate binder therapy. The objective to evaluate the effect of tenapanor alone or in combination with phosphate binders to achieve target serum phosphorus (s-P) levels of ≤5.5 mg/dL when tenapanor is administered as the core therapy (alone or in combination with phosphate binders) for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
This is a 1:1:1 randomized controlled blinded superiority trial to evaluate the impact of perioperative immunosupplementation on immune function following resection for hepatopancreaticobiliary (HPB) malignancy. Two variations of immunosupplementation will be compared to control nutritional supplement containing whey protein with an additional teaspoon (tsp) of placebo oil. These variations will be 1) a powdered formula containing whey protein and arginine (Active A) with an additional tsp of lipid bolus containing omega-3 fatty acids, and 2) a powdered formula containing whey protein and arginine (Active A) with an additional tsp of placebo oil which does not contain omega-3 fatty acids. The control nutritional supplement will be a powdered formula containing whey protein with an additional tsp of placebo oil.	This is a randomized controlled blinded superiority trial to evaluate the impact of perioperative immunosupplementation on immune function following resection for hepatopancreaticobiliary (HPB) malignancy.
Critical illness may be induced by different underlying life-threatening diseases, such as infection, sepsis, trauma, respiratory insufficiency or hypoxia and severe neurological status. The associated endocrine, nervous, metabolic and immunological changes are defined as acute stress syndrome.~Although sepsis is one of the oldest syndromes in medicine, it is a challenging healthcare problem even nowadays. In spite of the era of modern an¬tibiotics and intensive therapy sepsis is still one of the leading causes of morbidity and mortality.~Based on the novel results and advances of pathobiology, management and epidemiology of sepsis, the definitions of the syndrome have been changed recently. Sepsis-3 consensus de¬fines sepsis as a life-threatening organ dysfunc¬tion caused by a dysregulated host response to infection.~The diagnosis of sepsis is most often not easy especially in newborns or in patients whose im¬mune response is not adequate. Therefore, it is of most importance to introduce diagnostic biomarkers which can predict or verify systemic inflammation as early as possible. These tests should also be applicable for monitoring of the disease progression and efficacy of therapy as well.~Salivary alpha-amylase is secreted from the salivary glands mainly in response to beta-adrenergic stimuli.~Salivary alpha-amylase (sAA) has gained rapid popularity as a non-invasive marker of sympathetic nervous system (SNS) activity. sAA is a digestive enzyme that breaks down starch into glucose and maltose, and enzymatic activity (in Units/ml) is used as a proxy for sAA concentration.~The use of salivary alpha amylase as a marker of sympathetic activity seems justified. Salivary alpha amylase release from the salivary glands is under strong control of local sympathetic nerves. Its salivary concentration rapidly increases during acute stress, and its use as a marker of sympathetic activation is also validated by pharmacological studies.	Critical illness may be induced by different underlying life-threatening diseases, such as infection, sepsis, trauma, respiratory insufficiency or hypoxia and severe neurological status. The associated endocrine, nervous, metabolic and immunological changes are defined as acute stress syndrome. Salivary alpha-amylase is secreted from the salivary glands mainly in response to beta-adrenergic stimuli. Salivary alpha-amylase (sAA) has gained rapid popularity as a non-invasive marker of sympathetic nervous system (SNS) activity.
Using a newer, more sensitive troponin test, we now know that troponin levels even below the threshold used to diagnose a heart attack identify patients who are at risk of having a heart attack in the future. Our research in patients with stable chest pain demonstrated that computed tomography coronary angiogram (CTCA) improved the diagnosis of coronary heart disease, leading to improvement in patient care that prevented many future heart attacks. This study will build on these two major strands of research to confirm whether these low levels of troponin can identify patients who have underlying coronary heart disease and may benefit from further testing and preventative treatment.~The investigators will evaluate consecutive patients presenting to hospital with suspected acute coronary syndrome and cardiac troponin concentration within the normal reference range for the presence of underlying coronary artery disease. All participants will be invited for an outpatient CTCA.~Findings from this study will help inform a randomised controlled trial to evaluate the role of CTCA in patients who have a heart attack ruled out, but are identified as intermediate risk on troponin testing.	Most patients presenting to hospital with chest pain are discharged home without further tests once a heart attack has been ruled out. Current strategies to assess patients with a suspected heart attack involve blood tests to measure troponin, a protein released into the bloodstream when the heart muscle is damaged. Despite having had a heart attack ruled-out, some patients have unrecognised coronary heart disease and are at risk of having a heart attack in the future. However, we do not know what is the best approach to identify and treat these patients.~This study will use a heart scan known as computed tomography coronary angiogram (CTCA) to look for underlying coronary heart disease in patients who have had a heart attack ruled out. In an earlier study, we performed this scan in patients referred to the outpatient cardiology clinic with stable chest pain and found that this improved the diagnosis of coronary heart disease, leading to improvement in patient care that prevented many future heart attacks. Our research has also demonstrated that troponin levels below the threshold used to diagnose a heart attack identify those who are at greater risk of having a heart attack in the future. The aim of this study is to confirm whether these low levels of troponin can identify patients who have underlying coronary heart disease and may benefit from further testing and preventative treatment.
As a result of climate change, heat waves are more frequent and of longer duration. These heat waves are associated with a higher risk of hospitalization and mortality in vulnerable populations such as people with cardiovascular disease or cardiovascular risk factors. It has been hypothesized that this observation may be explained by the cardiovascular demands imposed by heat exposure.~Heat exposure requires increased cardiac work that may place individuals with cardiovascular disease at risk of ischemic events if the metabolic demand is not compensated by adequate blood supply. However, the extent to which cardiac work increases during heat exposure remains unknown. The aim of this study is to test the hypothesis that heat exposure increases myocardial blood flow and that this increase is affected by age and coronary artery disease.	The purpose of this study is to determine the increase in myocardial blood flow during heat exposure and how this response is affected by age and coronary artery disease.
A multi-center sample collection study in patients presenting with pigmented lesion(s) suspicious for melanoma. All suspicious lesions should meet at least one of the ABCDE (asymmetry, border, color, diameter, evolving) criteria. Patients will be consented for the study and screened against the inclusion and exclusion criteria. Once the patient is determined to be acceptable for the study they will be assigned a unique patient number and tissue collection will begin. Tissue from the lesion will be collected using DermTech's non-invasive adhesive patch kit according to the instructions for use followed by surgical biopsy. Digital dermoscopy of the lesion is preferred but not required.	A multi-center sample collection study in patients presenting with pigmented lesion(s) suspicious for melanoma. All suspicious lesions should meet at least one of the ABCDE criteria.
High-intensity gait training is strongly supported in individuals poststroke to facilitate neuroplastic changes in the brain in order to maximize the recovery of functional independence. Individuals with contraversive pushing behaviors (CPB) poststroke are difficult to mobilize as a result of tilted posture with significant balance impairments, a tendency to push toward their hemiparetic side, and resistance to external correction. CPB has been reported in 12-18% of individuals receiving stroke rehabilitation and often leads to longer lengths of stay, poorer functional outcomes, and institutionalized discharge locations compared to individuals poststroke without CPB.~High quality evidence guiding physical therapy intervention, specifically gait training, in individuals with CPB is scarce. Traditional therapeutic interventions in individuals with CPB consists of progressing functional mobility while orienting to midline with various forms of visual and tactile feedback. To further guide best practice in this population, we plan to investigate the effect of two high-intensity gait training interventions on CPB in 10 individuals poststroke in the acute inpatient rehabilitation setting over the course of one year.~Individuals from the inpatient stroke unit at the Shirley Ryan AbilityLab will be recruited and placed into one of two intervention groups. Intervention for group one will consist of body-weight-supported treadmill training + overground gait training. Intervention for group two will consist of gait training in the EksoNR exoskeleton + overground gait training. The commercially available EksoNR is approved by the FDA for use in individuals with stroke diagnoses. We will also evaluate the effect of these interventions on functional outcomes including mobility, strength, balance, walking speed, and walking endurance in addition to measuring therapist burden when mobilizing individuals with CPB.~Both groups will receive their specified gait training intervention three sessions a week for at least three weeks until they discharge with the goal of maximizing the number of steps within a 60 minute session. Gait training interventions will be progressed to challenge individuals as appropriate in order to reach 70-85% of age-predicted maximum heart rate. A fourth session will be utilized to assess weekly outcome measures as part of the standard of care at the Shirley Ryan AbilityLab. There will be no restrictions set on therapy delivered outside of these intervention training sessions as individuals will be getting other therapies each day as the standard of care.	The purpose of this study is to investigate the effect of two high-intensity gait training interventions on contraversive pushing behaviors in individuals poststroke in the acute inpatient rehabilitation setting. We will also evaluate the effect of these interventions on functional mobility, strength, balance, and endurance. Furthermore, we intend to measure therapist burden when mobilizing individuals with contraversive pushing behaviors.
Over 5 million Americans suffer from heart failure (HF), and treating HF as a chronic condition is associated with significant costs. In addition, about 24% of the patients discharged with a primary diagnosis of HF are readmitted to the hospital within 30 days, representing a significant public health burden. While there have been efforts to predict and reduce 30-day hospital readmission initiated by the Centers for Medicare and Medicaid Services (CMS), no studies utilized daily physiologic data from wearables to identify at-risk patients.~The overall goal of this proposed pilot feasibility study is to utilize the Spire Health Tags in a heart failure patient population to ascertain the feasibility of capturing appropriate signals of respiration, pulse rate, activity, sleep patterns, and stress levels (calm/focused/tense during the day) for > 80% of the time in patients following HF hospitalization for a 30-day period. The investigators will do exploratory analysis of the changes in these physiologic variables during a 30-day period following HF hospitalization to identify risk markers that could predict 30-day readmission.	To evaluate the use of the Spire Health Tags in heart failure patients to determine the feasibility of capturing signals of respiration, pulse rate, activity, sleep patterns, and stress levels following HF hospitalization.
Approximately 600 patients with locally advanced, unresectable ESCC (AJCC 8th cStage II-IVA) will be randomized in a 2:1 ratio to receive either durvalumab + dCRT or placebo + dCRT. The primary objectives of this study are to assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in terms of progression free survival (PFS, per RECIST 1.1 as assessed by BICR) in all randomized patients (intent-to-treat [ITT] population) and PFS in patients with PD-L1 high tumors (PD-L1 High population).	This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study to assess the efficacy and safety of durvalumab administered concurrently with dCRT in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC).
In this study our objective is to compare two tibial ACL graft fixation systems in patients undergoing two different reconstructions technique (with simple and double bundle) in terms of tendon graft osteointegration, functionality and return to sports.~This is a single-center prospective randomized clinical trial with 112 patients diagnosed with anterior cruciate ligament rupture randomly allocated in four groups: single bundle with autologous bioabsorbable implant; single bundle with intrafix implant; double bundle with autologous bioabsorbable implant; double bundle with intrafix implant.~Primary outcome is graft ligamentization assessed in MRI images at 4-6 months	In this study our objective is to compare two tibial ACL graft fixation systems in patients undergoing two different reconstructions technique (with simple and double bundle) in terms of tendon graft osteointegration, functionality and return to sports.
Background The increase of all-cause mortality in the areas with high COVID-19 transmission rate due to COVID-19 deaths and the collateral damage to other healthcare problems is well known. However, the COVID-19 mortality is very low in the regions with low transmission rate and sufficient medical resources. In such regions, strict prevention measures were taken and these would alter the people's lifestyle and hygienic habits and further impact on non-COVID-19 deaths. Yet, there has no thorough investigation in this aspect.~Methods The number of registered deaths among 8.8 million permanent residents with specific causes from January 2018 to June 2020 were sourced from the Xuzhou Center for Disease Control and Prevention, Jiangsu Province, China. Death rates were calculated and compared by weeks, months, and years with a focus on the period of COVID-19 pandemic from Jan 24 to March 27, 2020. Numeric values of all-cause death and the death rates of non-COVID diseases were compared in time series at different time scales.	The increase of all-cause mortality in the areas with high COVID-19 transmission rate due to COVID-19 deaths and the collateral damage to other healthcare problems is well known. However, the COVID-19 mortality is very low in the regions with low transmission rate and sufficient medical resources. In such regions, strict prevention measures were taken and these would alter the people's lifestyle and hygienic habits and further impact on non-COVID-19 deaths. Yet, there has no thorough investigation in this aspect.
Popular topic: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (≥60 years old) Product name: Recombinant new coronavirus vaccine (CHO cell),Each dose contains 25μg/0.5mL/bottle (low dose), 50μg/0.5mL/bottle (high dose) Indications: Prevention of respiratory diseases caused by new coronavirus infection Research population: healthy people ≥60 years old Research Unit: Hunan Provincial Center for Disease Control and Prevention Research purpose: Main purpose: To evaluate the safety and tolerability of different doses of recombinant new coronavirus vaccine (CHO cells) in healthy people aged 60 years and above. Secondary purpose: to initially explore the immunogenicity and durability of different doses of recombinant new coronavirus vaccine (CHO cells).~Overall design: A single-center, randomized, double-blind, placebo-controlled trial design was adopted.~Immunization program: 0, 1, and 2 months. Dose: Divided into low-dose group (25μg/0.5mL) and high-dose group (50μg/0.5mL).~Study population: a healthy population of 60 years and above, a total of 50 cases, both men and women.~Test groups: 20 cases in the low-dose group, 5 cases in the placebo group; 20 cases in the high-dose group, 5 cases in the placebo group.~Research plan and implementation:Volunteers aged 60 and above signed the informed consent form and asked about medical history, residence history and other information and then performed relevant examinations, including height, weight, vital signs, physical examination, laboratory tests (blood routine, urine routine, blood biochemistry), urine Pregnancy (women of childbearing age). After the study number is assigned, the subjects will collect throat swabs for SARS-CoV-2 real-time fluorescent RT-PCR nucleic acid detection, and blood will be collected for SARS-CoV-2 IgM and IgG antibody detection. Subjects will be in accordance with 0, 1, and 2 months Vaccination procedures are carried out. According to the order of the dose from low to high, it is divided into two stages and inoculated sequentially. Among them, placebo/five people per dose group, test vaccine/20 people per dose group, and qualified subjects were randomly enrolled into the test vaccine group and the placebo control group. In the first phase, subjects in the low-dose group (20 cases) and the placebo group (5 cases) were randomly enrolled; the safety data of the first 7-day vaccination was evaluated by DSMB, and if the suspension/termination criteria were not met, the first In the second-phase study, subjects in the high-dose group (20 cases) and the placebo group (5 cases) were randomly enrolled. Follow-up to 30 days after each dose, if the suspension/termination criteria is reached, DSMB will decide whether to inoculate the follow-up doses; in other cases, the investigator will decide whether to inoculate the follow-up doses.~Safety endpoint:~1. The incidence of all AEs within 1 month after the first dose to the full course of vaccination:~Total AE incidence;~The incidence of AEs related to research vaccines;~The incidence of grade 3 and above AE;~The incidence of grade 3 and above AEs related to research vaccines;~The incidence of AEs leading to withdrawal;~The incidence of AEs related to research vaccines leading to withdrawal; 2. The incidence of all serious adverse events (SAE) and the incidence of SAE related to the vaccine within 12 months after the first dose to the full course of vaccination; 3. Changes in the clinical significance of the laboratory test indicators after each dose of inoculation compared to before the first dose.~Immunogenicity endpoint:~Humoral immunity: before the first dose of vaccination, 1 month and 6 months after the full vaccination, neutralizing antibodies of novel coronavirus (SARS-CoV-2), S protein binding antibody (IgG), RBD protein binding antibody (IgG) ) Positive rate; The levels of neutralizing antibodies against SARS-CoV-2, S protein binding antibody (IgG) and RBD protein binding antibody (IgG) and their relative immunity 1 month and 6 months after the full vaccination of all subjects Increase the multiple before.	Popular topic: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (≥60 years old) Research purpose: Main purpose: To evaluate the safety and tolerability of different doses of recombinant new coronavirus vaccine (CHO cells) in healthy people aged 60 years and above. Secondary purpose: to initially explore the immunogenicity and durability of different doses of recombinant new coronavirus vaccine (CHO cells).~Overall design: A single-center, randomized, double-blind, placebo-controlled trial design was adopted.~Study population: a healthy population of 60 years and above, a total of 50 cases, both men and women.~Test groups: 20 cases in the low-dose group, 5 cases in the placebo group; 20 cases in the high-dose group, 5 cases in the placebo group.
The differentiation between central diabetes insipidus (cDI) and primary polydipsia (PP) is cumbersome. To date the test with the highest diagnostic accuracy is copeptin measurement after hypertonic saline Infusion.~Instead of hypertonic saline Infusion, arginine infusion - known to stimulate growth hormone - is a potent stimulator of the neurohypophysis and provides a new diagnostic tool in the differential diagnosis of cDI. Copeptin measurements upon arginine stimulation discriminated patients with diabetes insipidus vs. patients with primary polydipsia with a high diagnostic accuracy of 94%. Glucagon has been shown to stimulate GH-secretion. In analogy to the known stimulatory effect of arginine Infusion it is hypothesized that glucagon might stimulate the posterior pituitary gland and could therefore be a novel diagnostic test in the polyuria-polydipsia syndrome.~This study is to evaluate copeptin values after the subcutaneous injection of glucagon in adults (healthy volunteers and patients with diabetes insipidus or primary polydipsia).~This study is planned as a double-blind randomized-controlled cross-over trial consisting of two parts, including healthy adults (study part 1 - proof of concept) and adults with known diagnosis of cDI or PP (study part 2 - pilot study). Study parts 1 and 2 will be conducted consecutively. If the results of study part 1 suggest that glucagon is a potent stimulator of Copeptin in healthy adults, study part 2 will be conducted. Participants will receive glucagon injection and placebo injection in random order.	This study is to evaluate copeptin values after the subcutaneous injection of glucagon in adults (healthy volunteers and patients with diabetes insipidus or primary polydipsia). It is to investigate whether glucagon stimulates the release of copeptin as a surrogate of vasopressin.
Title: A Single Arm Phase II Study of Pembrolizumab in combination with Lenvatinib in Patients with Advanced Biliary Tract Carcinoma after Progression on Standard Systemic Therapy Study Description: The prognosis for unresectable and metastatic biliary tract cancers (BTCs) including cholangiocarcinoma is poor with first line gemcitabine and cisplatin offering a median overall survival of 11.7 months. There is no standard second- or third-line therapy for advanced BTC, and this represents an unmet medical need for novel therapies. The immune system plays a critical role in the development of Advanced Biliary Tract Carcinoma (BTC) and chronic inflammation is a common underlying risk factor for BTC. VEGF signaling in BTC may lead to an immune suppression via inadequate tumor antigen presentation and an impaired T cell-mediated immune response directed against tumor antigens. Lenvatinib significantly decreased the population of immunosuppressive tumor-associated macrophages and increased interferon-γ-producing CD8+ T cells. Addition of PD-1/PD-L1 inhibitors helps reverse VEGF-mediated immune suppression, restore T cell function, and promote T cell tumor infiltration. The combination of lenvatinib and pembrolizumab has demonstrated promising activity with manageable adverse events in various solid tumor types.~The investigators will assess the efficacy and safety of the combination of pembrolizumab and lenvatinib in patients with advanced BTC who failed standard therapy in this phase II study.~Objectives and Endpoints:~Primary Objective: Evaluate the objective response rate (ORR) (RECIST1.1) of lenvatinib in combination with pembrolizumab in patients with advanced BTC after progression on standard systemic therapies Secondary Objective: Evaluate the safety and tolerability of lenvatinib+pembrolizumab in this population; Determine the duration of response (DOR), progression free survival (PFS), and overall survival (OS); Determine the ORR, PFS and OS of subgroups stratified by molecular signatures (tumor mutation burden, PD-L1 expression, microsatellite instability (MSI) status, isocitrate dehydrogenase (IDH) or FGFR mutation/fusion status) in a pre-planned post-hoc analysis; Define molecular correlates of response, including circulating biomarkers and tumor tissue biomarkers Study Population: The study will enroll 40 patients who have unresectable or metastatic, histologically-confirmed advanced BTC. Both male and female patients age of 18 years or older who have failed standard systemic therapy for advanced BTC with measurable disease, adequate bone marrow reserve and hepatic/renal function, and ECOG performance status (PS) 0-1 could be eligible to participate in the study after completing the study enrollment screening tests and procedures.~Phase: II Description of Sites/Facilities Enrolling Participants: The study will be conducted at Jiahui International Cancer Center, Shanghai Jiahui International Hospital, in collaboration with Zhongshan Hospital.~Study treatment/Intervention: Each cycle is defined as 21 days treatment of Pembrolizumab in combination with Lenvatinib. Treatment will be administered on an outpatient basis:~Pembrolizumab 200mg IV day 1 of every 21 day-cycles; Lenvatinib 20mg PO once daily for 21-day cycles Study Duration: 24-36 months Participant Duration: up to 24 months	The prognosis for unresectable and metastatic biliary tract cancers (BTCs) including cholangiocarcinoma is poor with first line gemcitabine and cisplatin offering a median overall survival of 11.7 months. There is no standard second- or third-line therapy for advanced BTC, and this represents an unmet medical need for novel therapies. The immune system plays a critical role in the development of Advanced Biliary Tract Carcinoma (BTC) and chronic inflammation is a common underlying risk factor for BTC. Vascular endothelial growth factor (VEGF) signaling in BTC may lead to an immune suppression via inadequate tumor antigen presentation and an impaired T cell-mediated immune response directed against tumor antigens. Lenvatinib significantly decreased the population of immunosuppressive tumor-associated macrophages and increased interferon-γ-producing cluster of differentiation 8+ (CD8+) T cells. Addition of programmed cell death protein 1 (PD-1)/programmed death-ligand (PD-L1) inhibitors helps reverse VEGF-mediated immune suppression, restore T cell function, and promote T cell tumor infiltration. The combination of lenvatinib and pembrolizumab has demonstrated promising activity with manageable adverse events in various solid tumor types.~The investigators will assess the efficacy and safety of the combination of pembrolizumab and lenvatinib in patients with advanced BTC who failed standard therapy in this phase II study.
This is a multi-site, randomized, single-blind (researchers), active treatment concurrent control trial with individuals aged 50 and older living with HIV who experience fatigue and live a sedentary lifestyle. The overall goals of this proposal are to determine whether high-intensity interval training (HIIT) can overcome physical function impairments and increased fatigue (Aim 1) and impairments in mitochondrial bioenergetics of older people with HIV (PWH) to a greater extent than continuous moderate-intensity exercise (CME) (Aim 2). The investigators further seek to determine whether a biobehavioral coaching intervention following either HIIT or CME can promote long-term adherence to physical activity (Aim 3), a crucial component of the sustainability of the intervention. This study will enroll 100 participants in Aurora, Colorado and Seattle Washington.~Physical function will be measured by a 400-meter walk test (400MWT) and the short physical performance battery in its original (SPPB) and modified (mSPPB) forms. Fatigue will be measured by the Lee Fatigue Scale (LFS) - a 7-item visual analog self-report scale that asks participants to rate from 0 to 10 how they feel right now. Mitochondrial bioenergetics will be assessed through blood draws, muscle biopsies and mitochondrial assays. Adherence to physical activity (PA) will be analyzed through ActiGraphy - measurement of PA duration and intensity on three planes of movement captured through PA monitors.~Finally, perceptions of PA will be determined through the analysis of qualitative interviews.~The hypotheses are that that investigators will see greater changes in mitochondrial bioenergetics with HIIT (AIM 1), and that these changes will be related to improved physical function and fatigue (Aim 2). The investigators expect that HIIT will result in greater exercise satisfaction and likelihood of long-term continuation of exercise (Aim 3). Using a coaching intervention for self-directed exercise that combines motivational interviewing and personalized support during the maintenance phase (Aim 3), the investigators seek to develop the ideal cocktail to promote healthspan among older PWH in the current era of ART.	This is a multi-site, randomized, single-blind (researchers), active treatment concurrent control trial with individuals aged 50-80 living with HIV who experience fatigue and live a sedentary lifestyle. The overall goals of this proposal are to determine whether high-intensity interval training (HIIT) can overcome physical function impairments and increased fatigue (Aim 1) and impairments in mitochondrial bioenergetics of older people with HIV (PWH) to a greater extent than continuous moderate-intensity exercise (CME) (Aim 2). The investigators further seek to determine whether a biobehavioral coaching intervention following either HIIT or CME can promote long-term adherence to physical activity (Aim 3), a crucial component of the sustainability of the intervention. This study will enroll 100 participants in Aurora, Colorado and Seattle, Washington. Data collection will occur at each visit, with baseline data collected at the initial visit. A 3-month follow-up will be conducted over the phone from the date of the final visit.
AIM To compare dimensional changes in extraction socket of single rooted teeth, 6 months post extraction, when grafted with xenograft versus allograft.~PRIMARY OBJECTIVE~Horizontal and vertical dimensional changes of extraction sockets as evaluated in a CBCT scan immediately post extraction and 6 months post extraction when grafted with xenograft versus allograft.~SECONDARY OBJECTIVE~Difference in horizontal dimensional changes in xenograft and allograft groups as measured intra-operatively after extraction and at re- entry 6 months post extraction.~Difference in vertical dimensional changes in xenograft and allograft groups as measured intra-operatively after extraction and at re- entry 6 months post extraction.~Difference in histologic analysis of bone biopsy cores taken in xenograft and allograft groups at 6 months re-entry from osteotomy site.~Difference in newly regenerated supracrestal bone height and volume will be measured directly from the segmented images from MicroCT.~NULL HYPOTHESIS~There is no difference between the two groups for any of the parameters evaluated.	To compare dimensional changes in extraction socket of single rooted teeth, 6 months post extraction, when grafted with xenograft versus allograft.
In context of an increase of bacterial infections in people who inject psychoactive substances (PS) all around the world and a lack of available scientific data, the investigators decided to set up a descriptive study on bacterial infection types and determinants in Injection Drug Users (IDUs).~Through a multidisciplinary approach between hospital departments (e.g. infectious diseases, emergency and addictology), the local addiction management and liaison team (ELSA) and the regional addictovigilance center, data were collected on appearance and course of bacterial infections in IDUs hospitalized at Montpellier University Hospital, France.~This study aims to provide medical data in order to better understand those infections and their determinants and provide information for potential future more specific observational studies.~The regional addictovigilance center is a member of the French Addictovigilance Network, which was established to monitor the potential for abuse and dependence of PS, and to provide information on the risk of addiction and advice for public health decision making, under the supervision of the French National Agency for Medicines and Health Products Safety. This surveillance system is principally based on spontaneous reporting by healthcare professionals and patients that is regulated by law. Collected data were extracted from those spontaneous reports (composed by data from the medical file, DxCare or notification by medical team). First data were collected in 2012.~In addition, the investigators offered patients to fill in an anonymous questionnaire* on hygiene habits which was not mandatory and had no influence on treatment, and was offered during the ELSA team intervention (questions from the questionnaire are classical risk reduction question on injection and hygiene practices).~Main results are the description of the infections and injection practices. There is no control group per se as all included patients are IDUs and have a bacterial infection. But the investigators infection (such as abscess or skin and soft tissue) and those with a systemic infection. The two groups were established after the recruitment was completed. This comparative analysis is only performed in order to better understand the development of infections. Descriptive and comparative analyses was performed by the Department of Medical Information.~*Data collected :~Age~Sex~Past history of bacterial infection linked to injection of a psychoactive substance~HIV and HCV status~Injected psychoactive substance~Injection practices (frequency, route, location)~Diagnosis~Bacterial analysis~Treatments and course~Hygiene questionnaire (attached file)	Bacterial infections in people who inject psychoactive substances
The prevalence of GDM is increasing all over the world. It has bad influence for both pregnant women and fetus. Early treatment is useful for GDM prevention. Therefore early screening is important for healthcare doctors to detect the potential patients. Glycated albumin (GA) is an optimal index for blood glucose evaluation compared to HbA1c, however it may be influenced by body weight and composition. The investigators are going to investigate the predictive ability of glycated albumin combined with body composition, including body weight, BMI, fat free mass and fat mass for gestational diabetes mellitus (GDM) diagnosis. This study recruit pregnant women before 12 weeks of their pregnant age and test GA level and body composition via bioelectrical impedance analysis. During 24-28 weeks of pregnant age, all participants will do the glucose tolerant test for GDM diagnosis.	This study is going to investigate the predictive ability of glycated albumin combined with body composition, including body weight, BMI, fat free mass and fat mass for gestational diabetes mellitus (GDM) diagnosis.
Metal or plastic biliary stents placement under ERCP is a well-established treatment for patients with benign biliary obstruction to relieve jaundice, a palliative treatment for patients with unresectable malignant pancreaticobiliary obstruction and a bridge to surgery for patients with resectable disease. Single or multiple plastic stents are recommended for patients with benign stricture of the common bile duct or malignant stricture if the expected survival is less than 4 months. The main limitation of long time plastic stents is stents occlusion. Biliary plastic stents are changed every 2 to 3 months due to an expected median patency from 77 to 126 days.Metal stents present a lower risk of recurring biliary occlusion, yet high cost and stents occlusion are eventually inevitable. The mechanism of biliary stents occlusion include biliary sludge of the accumulation of bacteria and duodenal biliary reflux .The anti-reflux barrier of Oddi's sphincter disappears after the insertion of biliary stents and the pressure in bile duct lowers the duodenale, which cause the retrograde flow of duodenal material into the biliary ducts. Besides, ordinary biliary plastic stent is short which can also shortens the length of duodenal biliary reflux . Therefore, trying to prevent the duodenal biliary reflux is very important in reducing biliary stents occlusion and it is gradually concerned by clinical researchers. Some studies have showed that plastic stents with antireflux valves can effectively reduce the biliary stent stricture and prolong the stents patency, which means reducing duodenobiliary reflux is surely useful for keeping biliary stent patency.So,we assume to explore an innovatively intraintestinal extended biliary stents with length of 26cm (reformed with nasobiliary tube ) as substitution for ordinary biliary plastic stent to prevent the duodenobiliary reflux by extending the length of duodenal content reflux and avoid the stents shift via suspending in intrahepatic duct. In this study,we will design a multicenter stratified randomized controlled trial to compare the patency of intraintestinal extended biliary stents and ordinary plastic biliary stents in patients with malignant or benign biliary obstruction respectively and evaluate the effect of intraintestinal extended biliary stents for the prevention of duodenobiliary reflux.~This prospective study will be performed at 6 tertiary hospitals in China.The investigators will recruit patients according to admission criteria and exclusion criteria.The patients stratified by malignant and benign biliary obstruction will be randomized (at a 1:1 ratio) to intraintestinal extended biliary stents group (experimental group) and ordinary plastic biliary stents group (control group).The experimental groups will be placed the intraintestinal extended biliary stents in intrahepatic bile duct in ERCP. The control group will be placed ordinary plastic biliary stents in ERCP. The primary endpoint is the duration of stent patency and the rate of stent occlusion.The secondary outcomes include the mortality of each group、adverse events and the rate of technical success.	Metal or plastic biliary stents placement under Endoscopic Retrograde Cholangiopancreatography(ERCP) is a well-established treatment for patients with benign biliary obstruction to relieve jaundice, a palliative treatment for patients with unresectable malignant pancreaticobiliary obstruction and a bridge to surgery for patients with resectable disease. The main limitation of long time plastic stents is stents occlusion. Biliary plastic stents are changed every 2 to 3 months due to an expected median patency from 77 to 126 days.Metal stents present a lower risk of recurring biliary occlusion, yet high cost and stents occlusion are eventually inevitable. The mechanism of biliary stents occlusion include biliary sludge of the accumulation of bacteria and duodenal biliary reflux .The anti-reflux barrier of Oddi's sphincter disappears after the insertion of biliary stents and the pressure in bile duct lowers the duodenale, which cause the retrograde flow of duodenal material into the biliary ducts. Besides, ordinary biliary plastic stent is short which can also shortens the length of duodenal biliary reflux . Therefore, trying to prevent the duodenal biliary reflux is very important in reducing biliary stents occlusion and it is gradually concerned by clinical researchers. Some studies have showed that plastic stents with antireflux valves can effectively reduce the biliary stent stricture and prolong the stents patency, which means reducing duodenobiliary reflux is surely useful for keeping biliary stent patency.So,we assume to explore an innovatively intraintestinal extended biliary stents (reformed with nasobiliary tube ) as substitution for ordinary biliary plastic stent to prevent the duodenobiliary reflux by extending the length of duodenal content reflux and avoid the stents shift via suspending in intrahepatic duct. In this study,we will design a multicenter stratified randomized controlled trial to compare the patency of intraintestinal extended biliary stents and ordinary plastic biliary stents in patients with malignant or benign biliary obstruction respectively and evaluate the effect of intraintestinal extended biliary stents for the prevention of duodenobiliary reflux.
This is A multi-center, randomized, double-blind, comparative clinical trial.~The primary objective is to evaluate whether the clinical efficacy of QL1206 and Xgeva® are similar in patients with bone metastases from solid tumors.~The secondary objective are to evaluate whether the clinical safety and immunogenicity of QL1206 and Xgeva® are similar in patients with bone metastases from solid tumors.	A multi-center, randomized, double-blind, comparative study to evaluate the clinical efficacy and safety of QL1206 and Xgeva® in patients with bone metastases from solid tumors.
The World Health Organization calls for an increase of psychosocial interventions for dementia-a global epidemic. Cognitive Stimulation Therapy (CST) is the only non-pharmacological therapy recommended by the National Institute for Health and Care Excellence for improving cognition for mild to moderate dementia. However, there is little guidance on how to maximise cognition for severe dementia. Advanced Cognitive Stimulation Therapy (ACST) will be the first evidence-based complex intervention for moderate to severe dementia developed within the Medical Research Council (MRC) framework and building upon CST's key principles. This feasibility randomised controlled trial (RCT) aims to 1) evaluate the feasibility of ACST 2) explore if ACST can improve the cognitive function, and QoL, as well as other outcomes including behaviour, engagement, and communication, for people with moderate to severe dementia. A sample of 32 participants will be recruited, where 16 will be randomly allocated to ACST, and 16 to treatment as usual (TAU). Data will be collected pre and post the 7-week intervention period. Improving cognition and QoL for people with moderate to severe dementia is vital because dementia's prevalence is projected to reach 152 million by 2050, resulting in excessive excess disability.	This study is a feasibility randomised controlled trial (RCT) for an evidence-based intervention for people with moderate to severe dementia. The psychosocial intervention is adapted from Cognitive Stimulation Therapy (CST) and developed within the Medical Research Council (MRC) framework.
The details of the proposed study are as follows:~Experimental group: using EverLift submucosal injection for polyps 4-9mm of the colon~Control group: not using EverLift submucosal injection for polyps 4-9mm of the colon~Methods:~Colonoscopy will be performed in the same standard of care manner as if no study was taking place.~If polyps 4-9mm are identified, the endoscopist is randomized to performing polypectomy with or without submucosal injection of EverLift.~After removal of the polypectomy, two biopsies are performed at the margin of the polypectomy site to identify residual lesion.~The polyp as well as well as the two biopsies are reviewed by a pathologist.	The focus of the study is to evaluate impact of submucosal injection of EverLift in achieving complete resection during polypectomy of polyps 4-9mm during colonoscopy.
High levels of psychological difficulty are often reported by patients with an open fracture. These patients frequently describe feeling distressed by the initial appearance of their scars and can struggle to adjust and prepare for the challenges they face on discharge from hospital. Patients' expectations about the appearance of their wounds and their role in the recovery process may be aided with access to visual material that the patient and their family can revisit as often as is helpful to them.~Therefore, the multi-disciplinary team involved in the care of these patients has developed two novel patient information videos. They include practical advice from staff about the recovery process, images of the wound throughout the healing process and ways to cope with the range of emotional responses that patients report following an open fracture. The experiences of previous patients are also included. The aim of this project is to evaluate the impact of viewing these videos on patients' ability to follow treatment recommendations made by the team, as well as their psychological and social functioning, as measured by standardised questionnaire responses. Additionally, the patient's experience of viewing the videos, in terms of how relevant and useful they found them, will be evaluated.~All adult patients with an open fracture attending the John Radcliffe Hospital Major Trauma Centre will be eligible to take part (unless they have a diagnosis of dementia, active delirium or traumatic brain injury). Participation will involve completing questionnaires whilst in hospital (within the first week and prior to discharge) and at a routine 3-month follow-up appointment. Patients will be randomly selected to either view the videos or receive treatment as usual. The questionnaire responses of patients in these two groups will be compared to help evaluate the videos.	The multi-disciplinary team involved in the care of major trauma patients with open fractures has developed two novel patient information videos. They include practical advice from staff about the recovery process, images of the wound throughout the healing process and ways to cope with the range of emotional responses that patients report following an open fracture. The experiences of previous patients are also included. The aim of this project is to evaluate the impact of viewing these videos on patients' ability to follow treatment recommendations made by the team, as well as their psychological and social functioning, as measured by standardised questionnaire responses. Additionally, the patient's experience of viewing the videos, in terms of how relevant and useful they found them, will be evaluated.