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- reporting past-year physical violence (using a modified version of The Revised Conflict Tactics Scales (CTS)) and current mild-to-moderate depressive symptoms (using Patient Health Questionnaire (PHQ)-9), as identified on a brief screen administered in the ED |
- accompanied by a consentable parent |
- own or have access to a text-message-capable mobile phone |
Exclusion Criteria: |
- medically/physically unable to assent |
- chief complaint of suicidal ideation, psychosis, or child abuse |
- in police custody |
- severe depressive symptoms |
SAY WHEN: TARGETING HEAVY ALCOHOL USE WITH NALTREXONE AMONG MSM: |
This is a double-blind, placebo-controlled trial of 120 binge-drinking MSM to 12 weeks of naltrexone 50mg, to be taken in anticipation of heavy drinking. Ethnically and racially diverse participants will be recruited using Respondent Driven Sampling as well as active field recruitment. MSM will be seen weekly for alcohol-metabolite urine testing, study drug dispensing, and brief counseling for alcohol use. Safety assessments and behavioral surveys will be completed monthly. |
Inclusion Criteria: |
- (1) Male gender (2) self-reported anal sex with men in the prior three months while under the influence of alcohol (3) at least one binge drinking (five or more drinks on a single occasion) session per week in the prior three months; (4) interested in reducing binge alcohol consumption; (5) HIV-negative by rapid antibody test or medical record documentation of HIV infection (HIV positive participants); (6) no current acute illnesses requiring prolonged medical care; (7) no chronic illnesses that are likely to progress clinically during trial participation; (8) able and willing to provide informed consent and adhere to visit schedule; (9) age 18-70 years; (10) baseline CBC, total protein, albumin, glucose, alkaline phosphatase, creatinine, BUN, and electrolytes without clinically significant abnormalities as determined by study clinician in conjunction with symptoms, physical exam, and medical history. |
Exclusion Criteria: |
- (1) Any psychiatric (e.g. depression with suicidal ideation) or medical condition that would preclude safe participation in the study; (2) known allergy/previous adverse reaction to naltrexone; (3) current use of/ dependence on any opioids or a known medical condition which currently requires/may likely require opioid analgesics; (4) opioid-positive urine at enrollment; (5) current CD4 count < 200 cells/mm3 (6) moderate/severe liver disease (AST, ALT > 3 times upper limit of normal); (7) impaired renal function (creatinine clearance < 50 ml/min); (8) currently participating in another intervention research study with potential overlap; (9) alcohol dependence as determined by SCID criteria (participants with non-dependent alcohol use disorders/symptoms of alcohol abuse [per DSM-IV] are eligible) (10) any condition that, in the principal investigator and/or study clinician's judgment interferes with safe study participation or adherence to study procedures; (11) not having a cell-phone that can send and receive text messages. |
IMPROVING OUTCOMES IN VASCULAR ACCESS: |
The IMPROVA study is designed to identify novel predictors of vascular access success or failure. Clinical assessment complimented by Doppler ultrasound is the only currently employed methods of assessing suitability for placement of arteriovenous fistulae (AVF). These techniques are not capable of predicting vascular access outcomes suggesting that other potentially measurable factors may play a part. |
Despite efforts to improve placement of AVF in both the haemodialysis incident and prevalent population, many patients continue to dialyse through a central venous catheter (CVC), exposing them to higher risks of infection, co morbidity and mortality than dialysing via an AVF. Furthermore, AVF primary failure rates are reportedly as high in 20-50% in published series confirming that ultrasound cannot inform the clinician sufficiently to accurately predict success or failure. |
The aim of this study is to perform enhanced assessments of arterial health preoperatively and correlate these measurements with early AVF outcome. We intend to perform pulse wave analysis and velocity; measure advanced glycation end products and assess endothelial function using a vascular occlusion test. We also aim to assess whether patient reported symptoms of hand function can predict AVF outcome. These non-invasive measurements will provide a more accurate picture of overall vascular health prior to AVF formation with the ultimate intention of informing the clinician as to the likelihood of success or failure. |
Purpose of proposed investigation The IMPROVA study will utilise novel non-invasive methods of arterial health assessment and correlate these measurements with the early outcomes of AVF formation. The development of new techniques to inform the clinician pre-operatively will aid in a more tailored approach to fistula planning, predict inevitable failures and consequently improve success rate. The ultimate aim is to identify novel methods of predicting fistula failure to prevent patients from developing into a cycle of consecutive failure, catheter dependence and therefore worse overall outcomes. |
Background Despite the merits of autologous arteriovenous fistulas (AVF), failure rates remain high with 20-50% failing to mature. As a consequence many patients will suffer multiple attempts at establishing arteriovenous access and initiate dialysis on a Central Venous Catheter (CVC) thereby extending this risk of subsequent failure and increasing the risk of mortality and serious comorbidity. |
Predictors of maturation have been reported in a number of studies. The mainstay is pre-operative vascular mapping by duplex ultrasonography (DUS) which relies on vessel size and site. Whilst this has demonstrated improved patency and decreased early failure rate vascular measurements are unable to independently predict outcome of fistula success suggesting other contributing factors. |
The process of maturation can be modelled around changes in blood flow, flow patterns and subsequent vessel dilatation and remodelling. The ability of the artery and vein to dilate is essential to fistula maturation. |
Factors that influence vessel remodelling following fistula formation have been under investigated in this important aspect in the management of kidney disease. Arterial stiffness refers to the distensability, compliance and elastic modulus of the arterial vascular system. It is found to increase with age, diabetes mellitus, atherosclerosis and end stage renal disease. Aortic pulse wave velocity is considered the gold standard for assessing arterial stiffness and the pulse wave Vicorder©Skidmore Medical is a non-invasive, easy to learn and reproducible method of assessing stiffness. Increased aortic pulse wave velocity has been independently associated with adverse cardiovascular outcome in large prospective studies including specifically patients with end stage renal failure. Advanced glycation end products (AGEs) have also been implicated in the development of vascular pathology resulting in AVF failure. The measurement of advanced glycation end products, using the AGE reader©Diagnoptics Technologies, offers a new avenue to establish the association between AGE levels and AVF outcomes. Furthermore, potential therapeutic options exist for improving the AGE-related vascular biology of AVFs with evidence that aminoguanine, ALT-946, ALT-711, statins, pyrodoxamine and dietary modifications can reduce AGE levels. Endothelial function is another aspect of arterial health that has been under reported in vascular access research. The INVOS® spectra machine uses near infrared spectroscopy to measure the mixed arteriovenous saturations of deep tissues as a reflection of perfusion. Manipulation of this environment using a vascular occlusion test can provide invaluable information regarding endothelial responsiveness. Patient reported symptoms of vascular health may also provide important information in the search for novel predictors of AVF outcomes. Many vascular diseases have associated symptoms that reflect severity and direct questioning of patients regarding the vascular health of their upper limbs may offer further guidance in the placement of AVF. |
The combination of these non-invasive, easy to learn and reproducible tests offers an exciting opportunity to identify predictors of and improve outcomes in AVF formation. |
All patients with end stage renal disease referred for assessment in vascular access clinic. |
Inclusion Criteria: |
Age 18 years or more. All patients referred to the vascular access clinic. Able to give valid informed consent. |
Exclusion criteria Unable to give informed consent. <18 years old Prisoners |
ASSESMENT OF A PREDICTIVE MODEL DOSAGE OF EPO IN HEMODIALYSIS PATIENTS: |
Assesment of a predictive model of anemia management: Dosage of erythropoietin (EPO) and Iron adminsitration in hemodialysis patients. |
Anemia in patients on hemodialysis (HD ) is common and although usually responds well to treatment with Erythropoiesis Stimulating Agents (ESAs ) , this dosage , based on different clinical protocols , often ignores the high variability inter- and intra -individual in patient response . The result leads to swings in the objective by different dosage range that is associated with multiple risks and side effects. There are artificial intelligence-based optimization methods that predict treatment with ESAs in maintaining patient hemoglobin target range . So far the model has been validated for the long half-life of EPO ( darbepoetin ) with promising results. |
HYPOTHESIS: Maintaining patients in Hb levels ESAs range using short half-life , avoid the one hand , the need for transfusions and, secondly , the levels exceeding the upper range ( overshooting ), preventing the onset of a increased cardiovascular risk events. |
RELEVANCE:The results allow us to validate the model with short half-life ESAs optimizing the management of anemia and improving comorbidity associated with overdosage. |
SUMMARY: |
Prospective observational study of paired data. Data obtained from the data base Euclid . Data will be collected by clinical teams according to standard clinical practice. Informed at the time of admission to the clinic consent will be obtained . All patient data including to november 15th 2014 and who have completed the study period to 30 april 2015. The results will be compared with those prior to the patient's inclusion in the study were processed. |
To detect a difference of 10% in the percentage of patients in the hemoglobin target range after intervention (from 70% to 80%) we will need a minimum sample size of 268 patients assuming an alpha error of 0.05, a beta error of 0.2 and a correlation between both observations of 0.1. |
Patients on hemodialysis |
Inclusion Criteria: |
- > 18 Years |
- > 3 Months on HD / OLHDF |
- Treated with ESAs( epoBeta ) from> 3 Months |
Exclusion Criteria: |
- Chronic inflammatory diseases |
- Liver Cirrhosis |
- Active Neoplasms |
- Immunosuppression or other antiinflammatory medication |
- Patients who do not require treatment with ESAs |
STUDY OF CIRCULATING MICROPARTICLES IN GIANT CELL ARTERITIS: |
To demonstrate that microparticles (MPs), having a powerful procoagulant potential, are in larger amounts in the blood of patients with histologically proven giant cell arteritis (GCA), compared with patients matched for age, sex and with or without inflammatory syndrome. |
primary and secondary care hospital |
For GCA group: |
Inclusion Criteria: |
- Men and women ≥ 18 years of age Patient affiliated to social security regimen |
- Informed and having signed the consent form to take part in the study. |
- Diagnosis of GCA, meeting at least 3 of the following 5 American College of Rheumatology (ACR) criteria for the diagnosis of GCA, including inflammatory syndrome and having |
- Either temporal artery biopsy showing characteristic GCA abnormality |
- Or inflammatory arteritis on imaging examination |