Effect of Lithium and Divalproex in Alzheimer's Disease

Summary: This study will examine the effect of the drugs lithium and divalproex (Depakote) on tau proteins, a type of protein in the brain and spinal fluid that are altered in patients with Alzheimer's disease. Both drugs are approved by the Food and Drug Administration to treat mood disorders, and both have been shown in animal studies to decrease the amount of altered tau protein. This study will determine whether lithium alone or in combination with divalproex reduces the altered tau protein in the spinal fluid of patients with Alzheimer's disease.~Patients with Alzheimer's disease who are between 40 and 90 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, neurologic and neuropsychological evaluation, blood and urine tests, electrocardiogram (EKG), and, if needed, a magnetic resonance imaging (MRI) scan of the brain.~Participants undergo the following tests and procedures:~Drug treatment: Patients take study drugs for 6 weeks.~Weekly clinic visits: Patients come to the clinic once a week for a physical examination, blood and urine tests, a review of drug side effects, and to receive the next week's supply of medications.~Lumbar puncture (spinal tap): Patients have a lumbar puncture at study weeks 2, 4, and 6 to measure various brain chemicals and tau proteins in the cerebrospinal fluid (CSF), which bathes the brain and spinal cord. For this test, a local anesthetic is given and a needle is inserted in the space between the bones in the lower back where the CSF circulates below the spinal cord. A small amount of fluid is collected through the needle.~Follow-up visit: Two weeks after completing the study medication, patients return to the clinic for a final evaluation, including a physical examination and blood and urine tests.
Inclusion criteria: inclusion criteria:

 Patient is between the ages of 40 and 90 (inclusive).

 Patient will have a diagnosis of AD; the study will be confined to patients who are able to provide consent (pass a capacity assessment).

 The modified Hachinski Ischemia Score must be less than 4.

 Brain MRI performed within 15 months of enrollment must be compatible with the diagnosis of AD.

 Patient and/or caregiver are willing to adhere to protocol requirements as evidenced by written, informed consent.

Exclusion criteria: :

 Patients meeting any of the following

:

 Patients meeting any of the following


Effect of Dexamethasone Added To Bupivacaine During Caudal Block

Summary: It is a prospective double blind randomized study on the effect of dexamethasone added to bupivacaine with plain bupivacaine for caudal block in patient for herniotomy.~96 patients between the ages 1-6 years will be randomly selected and divided into two groups; B and BD.~Group B will receive 1ml/kg bupivacaine 0.25% (maximum volume 20mls) and group BD will receive a mixture of 0.2mg/kg dexamethasone in 1ml/kg bupivacaine 0.25% (maximum volume = 20mls).~Data taken will then be analyzed and interpreted.
Inclusion criteria: inclusion criteria:

 Patients aged 1-6 years, classified as American Society of Anesthesiologist (ASA) 1 and 11 who are undergoing herniotomy and whose parents or legal guardian has duly signed an informed consent form.

Exclusion criteria: :

 Patients with hypersensitivity to any local anesthetics

 Children with Bleeding diathesis

 Presence of Infections at puncture sites

 Preexisting neurological disease

 Patients with diabetes mellitus

 Failure to consent by parents


Multimodal MRI Characteristics of Psychotherapy Response in Late Life Depression

Summary: The specific focus of this study is to gather data regarding the effects of a psychological therapy known as Problem Solving Therapy (PST) on cerebral blood flow (CBF), cortical gray matter (GM) atrophy, subcortical white matter (WM) lesion burden, and measures of cognitive function in subjects with Late Life Major Depressive Disorder (LLD). This research goal will be achieved by recruiting 110 individuals over the age of 65 with LLD. The primary outcomes will be change in CBF, change in GM atrophy, change in WM lesion, change in cognitive function, and change in depression severity from baseline to the end of 12 weeks of PST.
Inclusion criteria: inclusion criteria:

 Current DSM-IV diagnosis of MDD, unipolar type, without psychotic features and 6 weeks minimum duration of current depressive episode.

 Moderate severity of depression using the Hamilton Depression Rating Scale (HDRS > 20).

 English speaking, male or female

 65 years of age or older

 Good general health

 Able to give informed consent

Exclusion criteria: :

 Antidepressant use or psychotherapy within the past 6 weeks or electroconvulsive therapy within the past 6 months.

 Recent history (<6 months) of substance or alcohol abuse or dependence (DSM-IV criteria).

 Use of cognitive enhancing medications.

 Current diagnosis of Post-Traumatic Stress Disorder or other Axis 1 psychiatric disorder.

 Neurological diseases (e.g., Parkinson's disease, epilepsy, cortical stroke, Alzheimer's disease, traumatic brain injury) or dementia.

 History of surgical procedures affecting study outcomes.

 Contraindications for MR exam, i.e., no claustrophobia, no paramagnetic metal implants, able to fit in the MRI machine comfortably (BMI ≤ 38).

 Acute or uncontrolled medical illness or medication use impacting cognitive function.


The Effects of Vacuum-Compression Therapy on the Healing of Diabetic Foot Ulcers

Summary: the objective of this study is to evaluate the impact of vacuum-compression effects of Vasotrain on the diabetic foot ulcers using stereological method based on Cavalieri's principle in diabetic patients.
Inclusion criteria: inclusion criteria:

 A diabetic foot ulcer corresponding to grade 2

 No history of deep venous thrombosis and no hemorrhage in ulcer

Exclusion criteria: :

 Significant loss of protective sensation

 Hemorrhage during treatment

 Vertigo

 No completion of treatment


Safeguard Your Smile an Oral Health Literacy Intervention Promoting Positive Oral Hygiene Self-care Behavior

Summary: The purpose of the investigators' study is to assess effectiveness of community based oral health literacy intervention promoting positive oral hygiene self-care behavior among Montreal's Punjabi immigrants.
Inclusion criteria: inclusion criteria:

 Punjabi immigrants who are Montreal residents

 Be in good general health

 Will give written informed consent

Exclusion criteria: :

 Non permanent residents e.g. refugees

 Presence of orthodontic appliances

 Having any disease of soft/ hard oral tissues e.g. advanced periodontitis

 Having any systemic disease e.g. diabetes

 On certain medications such as phenytoin.

['Safeguard Your Smile an oral health literacy intervention']


Local Versus Systemic Thrombolysis for Acute Ischemic Stroke (SYNTHESIS)

Summary: The purpose of this study is to determine whether intra-arterial rt-PA within 6 hours from an ischemic stroke onset, compared with intravenous infusion of the same drug within 3 hours, increases the proportion of independent survivors at 3 months.
Inclusion criteria: inclusion criteria:

 Sudden focal neurological deficit attributable to a stroke

 Clearly defined time of onset, allowing initiation of intravenous treatment within 3 hours of symptoms onset and intra-arterial treatment within 6 hour of symptoms onset.

 Age between 18 and 80 years

Exclusion criteria: :

 Disability preceding stroke consistent with a modified Rankin scale score of 2-4 (see glossary for Rankin scale)

 Coma at onset

 Severe stroke as assessed clinically (e.g. NIHSS>25)

 Rapidly improving neurological deficit or minor symptoms

 Seizure at onset of stroke

 Clinical presentation suggestive of a subarachnoid hemorrhage (even of CT scan is normal) or condition after subarachnoid hemorrhage from aneurysm

 Previous history of or suspected intracranial hemorrhage

 Previous history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)

 Septic embolism, bacterial endocarditis, pericarditis

 Acute pancreatitis

 Arterial puncture at a non compressible site (e.g. subclavian or jugular vein puncture) or traumatic external heart massage or obstetrical delivery within the previous 10 days

 Another stroke or serious head trauma within the preceding 3 months

 Major surgery or significant trauma in past 3 month

 Urinary tract hemorrhage within the previous 21 days

 Documented ulcerative gastrointestinal disease during the last 3 months, esophageal varices, arterial-aneurysm, arterial/venous malformations • Neoplasm with increased bleeding risk

 Severe liver disease, including hepatic failure, cirrhosis, portal hypertension (esophageal varices) and active hepatitis

 Current therapy with intravenous or subcutaneous heparin or oral anticoagulants (e.g. warfarin sodium) to rise the clotting time

 Known hereditary or acquired hemorrhagic diathesis, baseline INR greater than 1.5, aPTT more than 1.5 times normal, or baseline platelet count less than 100,000 per cubic millimeter

 Baseline blood glucose concentrations below 50 mg per deciliter (2.75 mm/L) or above 400 mg per deciliter

 Hemorrhagic retinopathy, e.g. in diabetes (vision disturbances may indicate hemorrhagic retinopathy)

 Any history of prior stroke and concomitant diabetes

 Prior stroke within the last 3 months

 Known contrast sensitivity

 Severe uncontrolled hypertension defined by a blood pressure ≥ 185 mmHg systolic or diastolic ≥ 110 mm Hg in 3 separate occasions at least 10 minutes apart or requiring continuous IV therapy

 Prognosis very poor regardless of therapy; likely to be dead within months.

 Unlikely to be available for follow-up (e.g., no fixed home address, visitor from overseas).Any other condition which local investigators feels would pose a significant hazard in terms of risk/benefit to the patient, or if therapies are impracticable.

 Computed tomographic (CT) scan

['local interarterial recombinant tissue plasminogen activator', 'intravenous (IV) rt-PA']


The Optimization of Mycoplasm Pneumonia Antibiotic Therapy

Summary: Mycoplasma pneumoniae, an important pathogen of community acquired pneumonia,are becoming more and more resistant to macrolide. The study aim is to optimize anti-infection therapy.
Inclusion criteria: inclusion criteria:

 Confirmed community acquired pneumonia

 60ys≥age≥18 ys

 Respiratory symptom (cough accompanied by little or no sputum)

 New infiltration showed by chest radiology(x-ray or CT)

 Lung signs was not obvious

 White blood cell<10,000/mm3

 Without underlying diseases or mild

Exclusion criteria: :

 Age<18ys or >60ys

 Pregnancy or breast-feeding

 Over one week after the onset of symptoms

 HIV infection

 Recent 90-day hospitalized history(length of stay greater than 2 days)

 Live in nursing homes or rehabilitation hospitals

 Taken macrolides or quinolones medicines before enrollment

['Moxifloxacin', 'Cephalosporins and azithromycin']

Moxifloxacin
Cephalosporins and azithromycin


Cross-sectional Characterization of Idiopathic Bronchiectasis

Summary: Background:~- Bronchiectasis is a type of lung condition in which the lungs airways are abnormally stretched and widened. This stretching and widening makes it difficult for mucus and other substances to move out of the lungs, encouraging the growth of bacteria and leading to breathing problems or infection. Bronchiectasis can be caused by genetic disorders or diseases such as tuberculosis or rheumatoid arthritis. Researchers are interested in developing better ways to diagnose and treat a lung problem called idiopathic or unexplained bronchiectasis.~Objectives:~- To better describe the physical characteristics, radiographic patterns, and airway microbiology of unexplained bronchiectasis and to look for possible genetic links or risk factors.~Eligibility:~Individuals at least 18 years of age who have a chronic cough and who have had a CT scan that has revealed signs of bronchiectasis.~Current smokers or those who have smoked for at least 10 years, as well as individuals who have known causes of bronchiectasis or who have had organ transplants, are not eligible to participate.~Design:~Participants will have one outpatient clinic visit for evaluation with a physical examination including detailed body size measurements and medical history and for collection of blood samples for routine lab tests and genetic analyses and a chest x-ray if no recent one is available.~Participants will also have tests of lung function, and measurement of a gas called nitric oxide in the nose. Participants whose initial tests show abnormal results may also be asked to have a nasal scrape to collect cell samples and/or a skin sweat test to measure salt concentrations.~Participants will also have a sputum specimen collected during the visit and will be asked to collect two additional early morning sputum samples and a mouth rinse at home within 2 weeks of the clinic visit, and mail the sample collection materials to the research team.
Inclusion criteria: inclusion criteria:

 The criteria for participants to enter the study mandates that each patient have received a standard (current clinical practice) diagnostic evaluation that includes a CT scan of the chest to document bronchiectasis, prior to enrolling in the Consortium study. To enter this protocol, adults must have bronchiectasis and meet the following criteria:

 Males or females, age greater than or equal to18 years

 Chronic cough

 An available CT of the chest (on a CD) that shows evidence of dilated airways fulfilling radiographic criteria for bronchiectasis in more than one lobe

 Ability to provide informed consent, including HIPAA consent

Exclusion criteria: :

 A participant should not be in the study if they have not had a standard clinical evaluation to rule out other potential causes of chronic sino-pulmonary disease.

 Known diagnosis of cystic fibrosis with classic clinical presentation and elevated sweat chloride levels and/or two known disease-causing CFTR mutations

 History of tuberculosis or other known explanation for bronchiectasis, such as alpha 1-antitrypsin deficiency (ZZ or ZS), confirmed or probable PCD, inflammatory bowel disease, rheumatoid arthritis, Sjogren s syndrome, allergic bronchopulmonary aspergillosis, or documented primary or acquired immunodeficiency

 Current smoker or > 10 pack-year history of tobacco use

 Prior solid organ transplant

['Infection', 'Bronchial Diseases', 'Respiratory Tract Diseases']

Infection
Bronchial Diseases
Respiratory Tract Diseases


Multiple Patient Program to Ensure Access to LCZ696 Treatment to Patients Diagnosed With Heart Failure With Reduced Ejection Fraction (HF-rEF)

Summary: Novartis has set up this global Multiple Patient Program (MPP) treatment plan to provide access to life-saving treatment with LCZ696 for patients that were not previously exposed to LCZ696 but have no other option to receive LCZ696 in their country prior to market authorization OR commercial availability, based on local regulatory and legal requirements.
Inclusion criteria: inclusion criteria

 The patient(s) for whom the MPP is sought meets all of the following:

 Is suffering from a serious or life-threatening disease or condition

 Does not have access to a comparable or satisfactory alternative treatment (i.e., comparable or satisfactory treatment is not available or does not exist)

 Patient should be on optimized standard of care treatment, including treatment with ARBs or ACEI, beta-blockers and MRA;

 Intolerance to evidence-based target doses should be documented by the treating physician

 Meets any other relevant medical criteria for compassionate use of the investigational product

 Patients eligible for inclusion in this program have to fulfill all of the following criteria:

 Adult patients (but not younger than 18 year old) will be included, upon completion of written informed consent before any assessment is performed.

 Patients with a diagnosis of CHF NYHA class II-IV and reduced ejection fraction:

 • LVEF ≤ 35% at the time of screening for participation in the program (any local measurement, made within the past 6 months using echocardiography, MUGA, CT scanning, MRI or ventricular angiography is acceptable, provided there are no subsequent measurement above 35%)

 Patient had a hospitalization for HF within the last 12 months

 Patients must be on an ACEI or an ARB at a stable dose for at least 4 weeks prior to starting treatment with LCZ696

 Patients must be treated with a β-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks prior to starting treatment with LCZ696 (reason should be documented for patients not on CHF target doses per local guidelines, or in absence of that medication).

 An aldosterone antagonist should also be considered in all patients, taking account of renal function, serum potassium and tolerability. If given, the dose of aldosterone antagonist should be optimized according to guideline recommendations and patient tolerability, and should be stable for at least 4 weeks prior to starting treatment with LCZ696

Exclusion criteria:

 Patients fulfilling any of the following criteria are not eligible for inclusion in this program:

 The patient is eligible for participation in any of the IMP's ongoing clinical trials

 The patient has recently completed a clinical trial that has been terminated and other options (e.g., trial extensions, amendments, etc.) are available to continue a similar treatment.

 The patient is being transferred from an ongoing clinical trial for which the patient is still eligible for participation

 History of hypersensitivity or allergy to LCZ696 or to any of its metabolites; to drugs of similar chemical classes, ARBs, or NEP inhibitors; as well as known or suspected contraindications to LCZ696

 Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer

 Previous history of intolerance to recommended target doses of ARBs

 Known history of angioedema

 Requirement of concomitant treatment with both ACEIs and ARBs

 Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy)

 Symptomatic hypotension and/or a SBP less than 100 mm Hg over the last 4 weeks prior to starting treatment with LCZ696

 Estimated GFR below 30 mL/min/1.73m2 as measured by the simplified MDRD formula

 Presence of bilateral renal artery stenosis

 Serum potassium above 5.2 mmol/L during the week prior to starting treatment with LCZ696

 Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major CV surgery, percutaneous coronary intervention (PCI) or carotid angioplasty within the 3 months prior to starting treatment with LCZ696

 Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after the schedule date to start treatment with LCZ696

 Implantation of a cardiac resynchronization therapy pacemaker (CRT-P) or a cardiac resynchronization therapy defibrillator (CRT-D) or upgrading of an existing conventional pacemaker or an implantable cardioverter defibrillator (ICD) to CRT device within 3 months prior to starting treatment with LCZ696, or intent to implant such a device.

 Also, patients who had implantation of a conventional pacemaker or an ICD or had a revision of a pacemaker or other device leads within 1 month before starting treatment with LCZ696 are excluded.

 Heart transplant or ventricular assistance device (VAD) or intent to transplant (on transplant list) or implant a VAD

 History of severe pulmonary disease

 Diagnosis of peripartum or chemotherapy induced cardiomyopathy within the 12 months prior to starting treatment with LCZ696

 Documented untreated ventricular arrhythmia with syncopal episodes within the 3 months prior to starting treatment with LCZ696

 Symptomatic bradycardia or second or third degree heart block without a pacemaker

 Presence of hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation

 Presence of other hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic and sub-aortic stenosis

 Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs, including but not limited to any of the following:

 History of active inflammatory bowel disease during the 12 months before starting treatment with LCZ696.

 Current duodenal or gastric ulcers during the 3 months prior to starting treatment with LCZ696

 Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 2 x ULN prior to starting treatment with LCZ696, history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt

 Active treatment with cholestyramine or colestipol resins

 Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 3 x ULN prior to starting treatment with LCZ696, history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt

 Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (above 5 mIU/mL)

 Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method (if accepted by the local regulatory authority and ethics committee) or a barrier method plus a hormonal method

 Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progesterone agent.

 Reliable contraception should be maintained throughout the treatment and for 7 days after LCZ696 treatment discontinuation

 Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea, or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.

 Presence of any other disease with a life expectancy of < 3 years

 Any condition, not identified in the protocol that in the opinion of the treating physician is likely to prevent the patient from safely tolerating LCZ696 or complying with the requirements of the therapy.

['Heart Failure With Reduced Ejection Fraction (HF-rEF)']


Cognition and Exercise Training

Summary: The aim of study is to investigate the impact of two different training modalities (high intensity interval training (HIIT) versus moderate intensity continuous exercise training (MICET) on cognitive performance, cerebral oxygenation, cardiac output and physical fitness in older healthy adults, patients with metabolic syndrome, coronary heart disease and heart failure. The investigators hypothesized that HIIT modality will lead to a larger improvement in physical fitness (i.e. VO2peak), cardiovascular parameters (cardiac output and stroke volume) and cognitive performance at rest and during submaximal exercise. The primary endpoint will be the improvement in cognitive performance.
Inclusion criteria: inclusion criteria:

 Elderly healthy subjects : with no MetS and no-documented CHD, both males and females, aged>60 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living.

 Patients with metabolic syndrome and no-documented CHD, both males and females, aged > 18 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living. MetS will be defined according to recent updated criteria: presence of at least three of five criteria, namely abdominal obesity (waist circumference cut-off depending on the recently published ethnic-based variations, triglycerides > 1.70 mmol/l, decreased HDL-cholesterol (< 1.0 mmol/l in men and < 1.3 mmol/l in women), systolic blood pressure > 130 mmHg or diastolic blood pressure > 85 mmHg, and FPG > 5.6 mmol/l.

 CHD patients, both males and females, aged > 18 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living. Moreover, they must have documented CHD (prior myocardial infarction, prior coronary angiography or angioplasty, or documented myocardial ischemia on myocardial scintigraphy).

 Patients with documented stable chronic heart failure will be recruited if they show the following inclusion criteria:

 ≥18 years

 Left ventricular ejection fraction (LVEF) <40% (measured within 6 months of their enrolment by MUGA Scan, echo or radiological ventriculography)

 NYHA functional class I-III

 Optimal therapy at stable doses including a beta-blocker and an ACE inhibitor or ARA for at least 6 weeks prior to investigation (unless documented rationale for variation).

 Able to perform an symptom limited exercise test.

 Capacity and willingness to sign the informed consent form.

Exclusion criteria: :

 For healthy elderly subjects:

 age under 60 years

 lack of expressed written consent

 metabolic syndrome

 coronary heart disease

 chronic systolic heart failure

 resting left ventricular ejection fraction < 40 %

 symptomatic aortic stenosis

 chronic atrial fibrillation

 malignant exertional arrhythmias

 non-cardiopulmonary limitation to exercise (e.g: arthritis or claudication)

 severe exercise intolerance.

 For patients with metabolic syndrome:

 lack of expressed written consent

 coronary heart disease

 chronic systolic heart failure

 resting left ventricular ejection fraction < 40 %

 symptomatic aortic stenosis

 chronic atrial fibrillation

 malignant exertional arrhythmias

 non-cardiopulmonary limitation to exercise (e.g: arthritis or claudication)

 severe exercise intolerance.

 For patients with CHD

 lack of expressed written consent

 recent acute coronary event (< 3 months)

 chronic systolic heart failure

 resting left ventricular ejection fraction < 40 %

 symptomatic aortic stenosis

 severe non-revascularize coronary disease including left main coronary stenosis

 patient awaiting coronary artery bypass surgery

 chronic atrial fibrillation

 presence of permanent ventricular pacemaker

 malignant exertional arrhythmias

 non-cardiopulmonary limitation to exercise (e.g: arthritis or claudication)

 severe exercise intolerance.

 For CHF patients:

 Any relative or absolute contraindications to exercise training among patients with stable chronic heart failure according to current recommendations (Working Group on Cardiac Rehabilitation 2001)

 Fixed-rate pacemaker or ICD devices with heart rate limits set lower than the exercise training target heart rate.

 Major cardiovascular event of procedure within the 3 months preceding enrolment in the study.

 Atrial fibrillation

 Heart failure secondary to significant uncorrected primary valvular disease (except for mitral regurgitation secondary to LV dysfunction)

 Heart failure secondary to congenital heart disease or obstructive cardiomyopathy.

['high intensity interval training (HIIT)', 'moderate intensity continuous exercise training']

['Metabolic Syndrome', 'Coronary Heart Disease', 'Chronic Heart Failure']

Metabolic Syndrome
Coronary Heart Disease
Chronic Heart Failure


A Post Marking Study to Evaluate the Safety of FluMist in Children

Summary: To assess the safety of FluMist vaccination
Inclusion criteria: inclusion criteria:

 Healthy

 Age: born within the same calendar quarter as the reference FluMist vaccinee.

Exclusion criteria: :

 Children who have evidence of medical conditions that put them at high risk for complications of influenza (e.g., chronic cardiovascular and pulmonary disease) will be excluded from this control group.

['FLuMist', 'TIV (Injection)', 'Unvaccinated Control']

FLuMist
TIV (Injection)
Unvaccinated Control


Driving Simulator Performance After Intake of Zopiclone Sleeping Pills

Summary: Zopiclone, a widely used hypnotic drug, is frequently found in blood samples taken from drivers suspected of driving under the influence. In this study, the investigators aim to correlate zopiclone serum concentrations with degrees of driving impairment in healthy volunteers by use of a validated driving simulator. The investigators also aim to compare their results with the results from a previous study that investigated zopiclone impairment of cognitive and psychometric tests.
Inclusion criteria: inclusion criteria:

 Male

 Caucasian ethnicity

 Age 25-35 years

 Possession of a driver's licence for at least five years

Exclusion criteria: :

 Score ≥ 2 on the modified Apfel-scale to assess risk for motion sickness(*)

 History of driving under the influence of alcohol and/or illicit substances

 History or presence of alcohol or illicit drug abuse

 Former abnormal reaction to any hypnotic drug

 History of strong averse reactions to blood sampling procedures

 Regular (daily) intake of any prescribed drug, or intake of grapefruit juice or herbal remedies that can influence the metabolism of zopiclone (e.g. St John's wort)

 History of severe allergic reactions, or significant mental, cardiovascular, renal or hepatic disorder, or other significant disease as judged by the investigators

 Detection of any drugs of abuse on pre-session urine drug screening

 (*)Modified Apfel-criteria for prediction of postoperative nausea/vomiting:

 Smoker? yes 0, no 1

 History of nausea and/or vomiting following surgery, dental treatment, injections or similar procedures? yes 0, no 1

 History of car sickness after 10 years of age? yes 0, no 1

 A score of two or more points excludes participation.

['Zopiclone', 'Ethanol', 'Placebo pill', 'Placebo drink']

Zopiclone
Ethanol
Placebo pill
Placebo drink


Follow-up of AKI in Neonates During Childhood Years

Summary: The purpose of this study is to learn more about how to identify signs of early chronic kidney diseases in children who were born prematurely with low birth weight (less than 3 ½ pounds). Researchers plan to compare the kidney function in children who experienced acute kidney injury (AKI) in the Neonatal Intensive Care Unit (NICU) with those who did not experience it. Evidence from several studies and our experience at UVA show that older children who experienced AKI while in the Pediatric Intensive Care Unit (PICU) have increased risk of developing early chronic kidney disease, and they also show early changes in the urine and blood that is consistent with early chronic kidney disease. In this study, the investigators hope to determine if any of these changes can be detected in early childhood, and if so, at what age we can start detecting these changes.
Inclusion criteria: inclusion criteria:

 Premature birth for Premature groups

 UVA NICU admission prior to 2 days of life

 Birth weight less than 1500 grams for premature groups

 Premature AKI Study group: Acute Kidney Injury as defined by KDIGO modified criteria during NICU stay at UVA

 Premature no AKI Control group: No AKI during NICU stay

 Term no AKI Control group: No AKI and born at term

 Parental or legal guardian consent obtained

Exclusion criteria: :

 - Patients with Congenital Anomalies of the Kidney and Urinary Tract

['Neonatal Acute Kidney Injury', 'Childhood Chronic Kidney Disease']

Neonatal Acute Kidney Injury
Childhood Chronic Kidney Disease


Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia

Summary: This is a prospective descriptive cross sectional study to determine the percentage of patients presenting with dysphagia who are found to have eosinophilic esophagitis (EoE) and to establish which presenting factors warrant esophageal biopsies. We hypothesize that a greater than expected percentage of patients who are biopsies will have histologic changes consistent with EE.
Inclusion criteria: inclusion criteria:

 Patients aged 18-90 presenting with dysphagia or food impaction

 Ability to undergo esophagogastroduodenoscopy and biopsies

 No significant cardiopulmonary disease, or other contraindication to EGD

Exclusion criteria: :

 Contradiction to EGD and/or biopsies such as Boerhaave's syndrome, or history or bleeding disorder or elevated INR

 Inability to provide informed consent

 Esophageal varices


Integrating Nutrition Education & Household Food Production for Child Nutrition

Summary: In Ethiopia, a child-centered counseling approach is hypothesized to be more effective than the current nutrition and health education when investment on home-based food production is used as a platform for nutrition education. This project is proposed to evaluate the efficacy of a food-based package integrating child-centered nutrition counseling and home-based food production using a between-group comparative intervention study. The intervention comprises child-centered nutrition counseling for caretakers and support for 'developed' gardens and improved backyard poultry production.
Inclusion criteria: inclusion criteria:

 infants less than 12 month

 are permanent residents in the area;

 have no plan to move away during the intervention period;

 are willing to adopt the agriculture activities; and

 have adequate place and time to adopt developed gardens & backyard poultry production

Exclusion criteria: :

 infants with severe acute malnutrition warranting referral to nutrition rehabilitation program with Ready-To-Use Therapeutic foods

 severely ill infants with clinical complications warranting hospital referral; and

 infants with obvious congenital or chronic abnormalities that impair feeding or physical growth measurements.

['Child Centered Nutrition Counseling', 'no intervention']

Child Centered Nutrition Counseling
no intervention


Efficacy and Safety of Varenicline Among HIV-infected Patients

Summary: Cigarette smoking is a major cause of illness among HIV-infected patients (non-AIDS defining malignancies (especially lung cancer), non-AIDS bacterial infections and cardio-vascular diseases). Approximately 50% of HIV-infected patients are regular tobacco smokers. Tobacco smoking cessation has well known benefits on mortality and morbidity in the general population where tobacco cessation assistance programs are increasingly implemented. However, smoking cessation interventions have never been evaluated among HIV-infected patients. This trial aims at evaluating the efficacy and safety of varenicline for smoking cessation compared with placebo.
Inclusion criteria: inclusion criteria:

 HIV-infected patients

 adults

 regular smokers (at least 10 cigarettes a day during the last year)

 motivated to stop smoking

 followed in one of the participating clinical ward,

 signed written inform consent

Exclusion criteria: :

 current co-dependency to another psychoactive substance

 ongoing depressive episode

 history of suicidal attempt

 ongoing treatment by interferon

 treatment by efavirenz for less than three months or not tolerated

 previous use of varenicline

 ongoing treatment by bupropion-SR or nicotinic substitute

 ongoing pregnancy

 ongoing breastfeeding

 hypersensitivity to varenicline or to one of its excipients

 drivers, air traffic controller

['HIV Infections', 'Tobacco Dependence']


Immunogenicity and Safety Study of a Third Vaccination With FSME-IMMUN 0.5 mL in Subjects Previously Vaccinated According to a Rapid Immunization Schedule (Follow-up to Study 225)

Summary: The objective of this study is to investigate the immunogenicity and safety of a third vaccination with FSME-IMMUN 0.5 ml given approximately 12 months after the second vaccination in Study 225. In Study 225, two vaccinations were given using a rapid immunization schedule 12 ± 2 days apart.
Inclusion criteria: inclusion criteria:

 Male and female subjects who:

 received 2 vaccinations with FSME-IMMUN 0.5 ml during Study 225

 understand the nature of the study, agree to its provisions and provide written informed consent

 are clinically healthy (i.e. the physician would have no reservation vaccinating with FSME-IMMUN 0.5 ml outside the scope of the clinical trial)

 have a negative pregnancy test result at the first medical examination (if female and capable of bearing children)

 agree to employ adequate birth control measures for the duration of the study (if female and capable of bearing children)

 agree to keep a Subject Diary

Exclusion criteria: :

 Subjects who:

 have already been administered a third TBE vaccination elsewhere since receiving two vaccinations in Study 225

 have a history of infection with, or vaccination against, other flaviviruses since participation in Study 225 (e.g. yellow fever, dengue fever, japanese B encephalitis)

 have had an allergic reaction to one of the components of the vaccine since participation in Study 225

 suffer from a disease (e.g. autoimmune disease, immunodeficiency) or are undergoing a form of treatment (e.g., systemic corticosteroids) that can be expected to influence immunological functions

 have a known or suspected problem with drug or alcohol abuse (>4 liters wine/week or equivalent doses of other alcoholic beverages)

 have donated blood or plasma within 30 days of study entry

 have received a blood transfusion or immunoglobulins within 30 days of study entry

 are known to be HIV positive (an HIV test is not required specifically for this study)

 are simultaneously participating in another clinical trial including administration of an investigational product

 have participated in any other clinical study within 6 weeks prior to study start

 have participated in another Baxter vaccine study in the past 6 months (with the exception of follow-up studies)

 For female subjects: pregnancy or lactation

['Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl']


Outcomes for Chronic Obstructive Pulmonary Disease Moderate Exacerbators Initiating Treatment

Summary: Patients with moderate COPD as defined by GOLD guidelines constitute almost 46% to 54% of all diagnosed COPD patients. Yet limited data exists on characterizing this study population in terms of drug therapy patterns and COPD-related resource use and costs. The objective of the following study was to conduct an analysis in the real-world setting to (1) identify and characterize COPD patients with moderate exacerbations and (2) evaluate the impact of initiating different maintenance therapies in this population. Maintenance therapy medications include inhaled corticosteroids (ICS), long-acting beta agonists (LABAs), combination of ICS+LABA, and anticholinergics (ACs) including tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively referred to as ipratropium [IPR]).
Inclusion criteria: inclusion criteria:

 minimum age 40 years at index

 continuously enrolled in health plan

 diagnosis of COPD (ICD-9 codes of 491, 492, 496)

 at least one moderate exacerbation event as defined previously.

Exclusion criteria:

 Exclusionary comorbid conditions of respiratory cancer, cystic fibrosis, fibrosis due to tuberculosis (TB), bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary TB, or sarcoidosis

 Patients excluded if they did not receive treatment within the treatment assessment period following moderate exacerbation

 Receipt of maintenance medication in the pre-period

 Presence of treatment switch, discontinuation of index drug, or any COPD-related exacerbation during the treatment assessment period

['Fluticasone Propionate / Salmeterol Xinafoate Combination (FSC)', 'Anticholinergics (AC)']

['Pulmonary Disease, Chronic Obstructive']


Seroepidemiology of Japanese Encephalitis Virus Infection in Hualien, Taiwan

Summary: Japanese encephalitis (JE) is one of important zoonotic infectious diseases in Taiwan. JE caused by Japanese encephalitis virus (JEV) which transmitted by Culex tritaeniorhynchus and used swine as amplifying host. Infections leading to overt encephalitis are estimated to be 1 in 1000 cases. Among JE confirmed cases, approximately 25 percent of cases die and 50 percent of the survivals develop permanent neurologic and/or psychiatric sequelae. JEV circulated in Taiwan are belonged to genotype III and the vaccine strain selected from same genotype. Genotype I JEV was first detected in northern Taiwan in 2008 by CDC, and the same genotype JEV were detected in mosquito collected in central Taiwan by our group. In order to study the genotypic shift of JEV in Taiwan areas, and the effects of the replacement of genotype on vaccine, we will conduct the JEV seroepidemiology in Hualien county which was the highest incidence of JEV in Taiwan. The aims of this study were: (1) study the circulating of genotype I JEV in Hualien county; (2) determine the virulence of genotype I JEV in human; (3) differential diagnosis of JEV genotype I or III infection among confirmed cases; (4) measure the cross neutralizing activity, after immunized with genotype III JEV vaccine, against genotype I JEV; (5) determine the age-specific seroprevalence of JEV antibody; (6) estimate the annual risk of infection for JEV.
Inclusion criteria: inclusion criteria:

 Living in the specific 2 villages in Hualien county

 Aged 18-85

Exclusion criteria: :

 1. Difficulty to have blood test due to coagulopathy or small blood vessels


Non Operative Treatment for Acute Appendicitis

Summary: Case control studies that randomly assign patients to either surgical or non-surgical treatment yield a relapse rate of approximately 14% at one year. It would be useful to know the relapse rate of patients who have, instead, been selected for a given treatment based on a thorough clinical evaluation, including physical examination and laboratory results (all characteristics forming the Alvarado Score) as well as radiological exams if needed or deemed helpful. If this clinical evaluation is useful,the investigators would expect patient selection to be better than chance, and relapse rate lower than 14%. Once the investigators have established the utility of this evaluation, the investigators can begin to identify those components that have predictive value (such as blood chemistry analysis, or CT findings). This is the first step toward developing an accurate diagnostic-therapeutic algorithm which will avoid the risks and costs of needless surgery.~This will be a single-cohort prospective interventional study. It will not interfere with the usual procedures, consisting of clinical examination in the Emergency Department (ED) and execution of the following exams at the physician's discretion: complete blood count with differential, C reactive protein, abdominal ultrasound, abdominal CT. Patients admitted to Emergency Department with Lower Abdominal and suspicion of Acute Appendicitis not needing immediate surgery, are requested by informed consent to undergo observation and non operative treatment with antibiotic therapy (Amoxicillin and Clavulanic Acid). The patients by protocol should not have received any previous antibiotic treatment during the same clinical episode. Patients not undergoing surgery will be physically examined 5 days later. During this follow-up visit, the patient will be given information about the study, will be invited to participate, and will be asked to sign an informed consent form. If the patient is under the age of 18 years, consent will be obtained from a parent or other legal guardian.~Telephone (or email) follow-ups will be conducted at 15 days, 6 months, and 12 months (see attached schedule) to monitor the state of the illness.
Inclusion criteria: inclusion criteria:

 Age >14 years

 Lower / RIF Abdominal Pain

 Clinical Suspicion of Acute Appendicitis:

 i.e.

 Alvarado Score 5-6 (equivocal for acute appendicitis)

 Alvarado Score 7-8 (probably appendicitis)

 Alvarado Score 9-10 (highly likely appendicitis)

 Informed consent (patient or legal representative)

Exclusion criteria: :

 Diffuse peritonitis

 Antibiotic (Penicillin) documented allergy

 Ongoing previously started antibiotic therapy

 Previous appendectomy

 Positive pregnancy test

 IBD history or suspicion of IBD recrudescence

['Lower Abdominal Pain', 'Right Iliac Fossa Pain', 'Acute Appendicitis']

Lower Abdominal Pain
Right Iliac Fossa Pain
Acute Appendicitis


Pilot Study: Hypovitaminosis D, Hyperparathyroidism and Hypomagnesemia in Patients With Congestive Heart Failure

Summary: People with heart failure may have low magnesium and low vitamin D levels. They may also have abnormally high levels of parathyroid hormones. Magnesium and vitamin D are important chemicals that are not routinely measured in blood tests. We are studying how many people with heart failure have low levels of magnesium and vitamin D. We are also studying how many people with heart failure have overactive parathyroid glands and if that is related to their vitamin D levels.
Inclusion criteria: inclusion criteria:

 congestive heart failure

Exclusion criteria: :

 pregnant

 hospitalized within one month

 taking calcium, vitamin D or magnesium supplements

 proteinuria > 1g/24h

 creatinine clearance <35 (MDRD)

['Congestive Heart Failure', 'Hypovitaminosis D', 'Hyperparathyroidism']

Congestive Heart Failure
Hypovitaminosis D
Hyperparathyroidism


Study Of Angiomax In Infants Under Six Months With Thrombosis

Summary: The goals of this study are:~To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis;~To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in Infants Under Six Months with arterial or venous thrombosis;~To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (UH) or low molecular weight heparin (LMWH).
Inclusion criteria: inclusion criteria:

 Parent/legal-guardian has provided written informed consent before initiation of any study related procedures.

 Objectively confirmed thrombotic event by either doppler ultrasound, echocardiogram, CT scan, MRI, MR angiogram, MR venogram, venogram or arteriogram.

 Age less than 6 months .

 Gestational age greater than 35 weeks

 Expected life expectancy at least 14 days.

 No contraindication to anticoagulation i.e. bleeding complications.

Exclusion criteria: :

 Active or recent (less than 7 days) bleeding.

 Known allergy to Angiomax or hirudin, or known sensitivity to any component of the product.

 Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment.

 Refusal to undergo blood transfusion should it become necessary.

 Any other disease or condition, which, in the judgment of the Investigator would place a patient at undue risk by being enrolled in the trial.

 Baseline prolonged PT (>18 secs) or aPTT (>55 secs)

 Platelet count < 50,000 cells/mm3

 Birth Trauma

 Planned or indicated surgery within 30 days

 Major or minor bleeding event


The Effect of Radioactive Iodine Administration for Thyroid Diseases on H.Pylori Eradication

Summary: Because of the high iodine uptake in the stomach, radioactive iodine treatment for thyroid diseases (cancer or hyperthyroidism) or radioactive iodine administered for thyroid scan may be able to eradicate H.pylori infection from the stomach of patients infected with H.pylori.~Also to test the hypothesis that CagA virulent strains of H.pylori are more common in patients with thyroid cancer than with other thyroid diseases.
Inclusion criteria: inclusion criteria:

 Adult patients between the ages of 18 and 80.

 Patients with diagnosed thyroid disease referred for thyroid scan or treatment with radioactive iodine (131I).

 Patients who provide informed consent

Exclusion criteria: :

 Patients without diagnosed thyroid disease.

 Patients who are pregnant or breast feeding.

 Patients who have received previous treatment for H. pylori infection.

 Patients taking proton pump inhibitors.

 Patients with recent or current use of antibiotics.

 Patients allergic to iodine (131I).

['Helicobacter Pylori Infected Patients', 'Thyroid Cancer Patients', 'Hyperthyroidism']

Helicobacter Pylori Infected Patients
Thyroid Cancer Patients
Hyperthyroidism


Evaluating the Pulmonary Nodule With Imaging and Biomarkers

Summary: The study aims to determine if there are defining EBUS and confocal endoscopy features as well as exhaled alveolar gas VOC that can discriminate malignant pulmonary nodules or masses from benign etiology, thereby obviating unnecessary thoracotomy. Directly sampled alveolar gas VOC from patients with lung cancer will be compared against exhaled breath VOC for signature compounds that may complement CT in screening the population at risk.
Inclusion criteria: inclusion criteria:

 All patients aged above 21 years, capable of giving consent and suspected of lung cancer with radiological lung nodules and masses.

Exclusion criteria: :

 Patients with contra-indications to bronchoscopy and CT-TTNA that include active myocardial ischemia, uncorrected coagulopathy, severe respiratory distress, uncontrollable cough, and pregnancy will be excluded. Before females in the reproductive age are recruited, urine pregnancy test will be performed and confirmed negative.

['Olympus Ultrathin Bronchofibervideoscope (XP260F)']


Pre-discharge vs. Early Post-discharge Stress Testing and GRACE Score for Safe Discharge of ACS-patients With a Negative Hs-troponin T Result

Summary: New high-sensitivity cardiac troponin (hs-cTn) assays allow earlier detection of acute myocardial infarction (AMI). Furthermore, elevated values were associated with an increased risk of recurrent AMI or death. Therefore, guidelines recommend an early invasive strategy in patients with elevated admission values and kinetic changes. Other criteria for an early invasive strategy include a GRACE risk score >140 points or other cardiovascular risk factors. Hs-cTn assays allow discrimination of patients at very low and high risk. Studies confirmed safety of early discharge protocols in patients with unstable angina (UAP). The aim of this study is to 1) confirm the safety of early discharge without invasive strategy in patients with UAP and to 2) review the optimal timing of stress-testing. Therefore, patients are being randomized into 2 groups with pre-discharge and early post-discharge stress-testing. Endpoints are major adverse cardiovascular events within 30 and 90 days.
Inclusion criteria: inclusion criteria:

 patients presenting to the emergency department (chest pain unit)

 typical angina pectoris

 absence of symptoms since presentation

 at least 18 years

 low GRACE risk score (<140 points)

 informed consent, signed agreement

Exclusion criteria: :

 conditions with need for immediate workup

 mental disorders

 dementia

 pregnancy, breast feeding

['Troponin T', 'Major Adverse Cardiovascular Events', 'GRACE Score']

Troponin T
Major Adverse Cardiovascular Events
GRACE Score


Robot Aided Rehabilitation - Intervention

Summary: Sensorimotor impairments following stroke often involve complex pathological changes across multiple joints and multiple degrees of freedom of the arm and hand, thereby rendering them difficult to diagnose and treat. The objective of this study is to evaluate multi-joint neuromechanical impairments in the arm and hand, then conduct impairment-specific treatment, and determine the effects of arm versus hand training and the effects of passive stretching before active movement training.
Inclusion criteria: inclusion criteria:

 First focal unilateral lesion, ischemic or hemorrhagic

 Had a stroke 1-12 months prior to enrollment

 Rated between stages 2-4 on the Chedoke McMaster Stroke Assessment Impairment Inventory: Stage of Recovery of the Arm and Hand

Exclusion criteria: :

 Apraxia

 Score of less than 22 on the Mini Mental Status Exam

 Severe pain in the shoulder by a self-rating of 7 out of 10 or greater

 Severe contracture in the upper extremity

 Unable to sit in a chair for 3 consecutive hours

 Unrelated musculoskeletal injuries

 Poor fit into equipment used in study

 Botox injection in upper extremity within 4 months

 Concurrent participation in gait or upper extremity intervention studies

['Passive stretching', 'Passive movement', 'IntelliArm', 'Hand robot']

Passive stretching
Passive movement
IntelliArm
Hand robot


A Comparison of Propofol Versus Midazolam to Sedate Critically Brain Injury; Measurement of Cytokine Response and Assessment of Function

Summary: This is a prospective randomized controlled pilot study in traumatic brain injury (TBI) patients who are sedated with either propofol or midazolam to compare the cytokine response and neuropsychological outcomes with and without elevated blood alcohol levels.~Sedation is part of the standard treatment in patients with a TBI and has been proposed as a neuroprotective intervention in head-injured patients. Sedative regimens, such as midazolam and propofol, are not standardized and it is unclear whether sedation has a significant impact on recovery and outcome. A review of propofol versus midazolam in mechanically ventilated patients shows evidence that both provide effective sedation but there is lack of data to support one sedative over the other.~Cytokines are released in response to tissue injury and act to generate a variety of physiologic responses. The cytokine elevation has been correlated with the extent of tissue injury. This study will compare the cytokine distribution patterns at specific posttraumatic time points in patients with a TBI sedated with either propofol or midazolam. Additional analysis will compare the cytokine response in patients whom had elevated blood alcohol levels with those with normal levels. Neuropsychological testing will also be performed to determine the extent of brain injury and recovery.
Inclusion criteria: inclusion criteria:

 Ages 18 Years or older

 Males or Females

 Primary diagnosis of TBI, subarachnoid hemmorhage (SAH), intracranial hemmorhage (ICH), stroke

 Requires mechanical ventilation

 Requires or is receiving continuous IV sedation

Exclusion criteria: :

 Glascow Coma Score (GCS) of 3 persisting from the scene with bilaterally fixed dilated pupils with no appreciable chance of survival

 The inability to identify a next of kin or guardian to give consent if patient unable to consent

 Pregnant

 Allergy or contraindication to propofol

 Allergy to contraindication to midalozam

 Status epilepticus

 Current neuromuscular blockade

 Patient with a known hypersensitivity to propofol or midalozam

 Allergies to eggs, egg products, soybeans or soy products

 Acute narrow-angle glaucoma

['Intravenous sedation using propofol', 'Intravenous sedation with midazolam']

Intravenous sedation using propofol
Intravenous sedation with midazolam


Effectiveness of and Satisfaction With a Pharmacist-managed Travel Medicine Clinic

Summary: This study will evaluate the clinical effectiveness of, and patient satisfaction with, pre-travel consultations provided by a pharmacist with specialty training in travel medicine and the authorization to prescribe medications and administer vaccinations.
Inclusion criteria: inclusion criteria:

 Receiving a pre-travel consultation at the Travel Health Network clinic in St. Albert, Alberta, Canada

Exclusion criteria: :

 Travellers with an expected return date after September 1, 2016

 Those receiving consultations as part of a group with the same itinerary (e.g., families, group vacations) will be asked to identify one member to participate in order to minimize repetition among participants.


Satisfaction Survey for Amyotrophic Lateral Sclerosis (ALS) Patients Comparing Rooms With and Without Assistive Technology

Summary: The purpose of this study is :~To assess the ALS patient's satisfaction related to a hospital stay on the neurology floor of Hahnemann Hospital.~To compare the reported satisfaction of those individuals who stayed in a standard hospital room with those who stayed in Room 1455. Room 1455 is a room specifically set up with assistive technology related to environmental controls for individuals with disabilities.~To look at frequency of use of the various pieces of adaptive equipment.
Inclusion criteria: inclusion criteria:

 In-patients with probable or definite ALS, ages 18 - 90, staying on the neurology floor of Hahnemann Hospital

Exclusion criteria: :

 In-patients who do not meet the criteria of the diagnosis of ALS.

['Amyotrophic Lateral Sclerosis', 'Neurodegenerative Disease', 'Motor Neuron Disease']

Amyotrophic Lateral Sclerosis
Neurodegenerative Disease
Motor Neuron Disease


Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06332)

Summary: This is a multicenter, randomized, parallel design, double-blind study of mometasone furoate (MF) in pediatric subjects with perennial allergic rhinitis. The subjects 5 to 15 years of age with perennial allergic rhinitis will enter a no-treatment observation period of 7 days at minimum and eligibility for inclusion in this study will be assessed. Following the observation period, eligible subjects will be randomized to MF or MF placebo for a 2-week double-blind treatment. At each clinic visit (at the start of treatment and after 1 and 2 weeks of treatment or at discontinuation), nasal symptom scores, nasal findings, and adverse events (AEs), will be evaluated. A 30-day follow-up visit will take place after the completion (or discontinuation) of the 2-week treatment period, to confirm presence or absence of serious adverse events (SAEs) and trial procedure-related AEs.
Inclusion criteria: inclusion criteria:

 Pediatric subjects with perennial allergic rhinitis who satisfy all of the following main criteria:

 Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree, after the pretreatment observation period.

 Subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house dust-mite antigen).

 Male or female outpatients aged 5 to 15 years at the time of providing informed consent.

Exclusion criteria: :

 Subjects for whom any of the main


Safety/Tolerability, Pharmacokinetics/Pharmacodynamics (PK/PD) of LCZ696 in Patients With Stable Heart Failure

Summary: This study assess the safety/tolerability, PK/PD of LCZ696 in patients with stable heart failure.
Inclusion criteria: inclusion criteria:

 Patients with documented heart failure (NYHA class II-IV)

Exclusion criteria: :

 Use of both ACEi and ARB, ACEi and DRI, ARB and DRI treatment, or all three medications at Screening


Lithium for Low-Grade Neuroendocrine Tumors

Summary: The purpose of this study is to learn more about the effectiveness and side effects of lithium treatment for subjects with low-grade neuroendocrine tumors.
Inclusion criteria: inclusion criteria:

 Must have histologically confirmed metastatic low-grade neuroendocrine neoplasms. Small cell lung cancers, paragangliomas and pheochromocytomas are excluded. Pathologic diagnosis must be confirmed at the University of Wisconsin Carbone Cancer Center (UWCCC). Grading must be confirmed by pathologic review performed at UWCCC.

 Must have measurable disease

 Must have radiographic evidence of disease progression following any prior systemic therapy, chemoembolization, bland embolization, surgery, or observation.

 Must be ≥ 4 weeks from the completion of major surgery, chemotherapy, or other systemic therapy or local liver therapy to study registration

 Must be ≥ 3 weeks from the completion of radiation therapy to study registration

 The following laboratory values are to be obtained within 14 days prior to registration: Absolute neutrophils count (ANC) ≥ 1000/mm3; Platelets ≥ 75,000/mm3; Hemoglobin ≥ 8.0 g/dL; Total bilirubin less than or equal 2.0 X the upper limit of normal (ULN); AST less than or equal to 3 X ULN or less than or equal 5 X ULN if liver metastases are present; Creatinine less than or equal ULN; Serum sodium within normal limits

 PS = 0-2

 Capable of understanding the investigational nature, potential risks and benefits fo the study and able to provide valid informed consent.

 Must have available tissue specimens to be analyzed for pathologic confirmation.

 Age ≥ 18 years.

 Women must not be pregnant or lactating.

 Women of childbearing potential and sexually active males are required to use an accepted and effective method of contraception.

 Patients must not have known history of allergic reactions or adverse reactions to Lithium or derivatives.

 Patients are not allowed to be on concurrent chemotherapy or radiation therapy.

 Patients are excluded if they have any of the following:

 Gastrointestinal tract disease resulting in an inability to take oral medication (i.e. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, bowel obstruction, or inability to swallow the tablets.

 History of hypothyroid disease Significant, active cardiac disease

 Patients must not be taking the following medications: diuretics, ACE inhibitors, NSAIDs (except aspirin or sulindac), neuroleptics, tetracycline, COX2 (cyclooxygenase-2) inhibitors, citalopram, clovoxamine, escitalopram, femoxetine, fluoxetine, fluvoxamine, paroxatine, sertraline, and zimeldine.

 Must be willing to undergo a tumor biopsy pre and post therapy.

 Patients with a concurrent malignancy are allowed on study as long as the patient is not undergoing active treatment for their disease.

 Patients already taking Lithium for any reason are not allowed on study.
Exclusion criteria:


The Penumbra Liberty Trial: Safety and Effectiveness in the Treatment of Wide-Neck Intracranial Aneurysms

Summary: To assess the safety and effectiveness of the Penumbra Liberty Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial aneurysms in the internal carotid artery (ICA). The Liberty Stent System is an implantable device comprised of a stent and delivery system designed as an adjunct to embolic coils in the treatment of wide-neck, saccular, intracranial aneurysms. It has three components: an implant, an introducer sheath and a delivery wire assembly. The implant component is made of superelastic and biocompatible nitinol tubular material. Patients presenting with wide-neck, saccular, intracranial aneurysms in the internal carotid artery (ICA) from the cavernous segment to the carotid terminus (including the paraclinoid, ophthalmic, hypophyseal and posterior communicating segments) will receive stent assisted coiling by the Penumbra Liberty Stent with any approved embolic coils currently on the market. Wide-neck aneurysms are defined by a neck ≥4mm or a dome-to-neck ratio <2. Each patient will be followed and assessed for 2, 6 and 12 months after enrollment.
Inclusion criteria: inclusion criteria:

 At least 18 years old

 A wide-neck intracranial saccular aneurysm with a neck ≥ 4mm or a dome to neck ratio <2 in the ICA from the cavernous segment to the carotid terminus (including the paraclinoid, ophthalmic, hypophyseal and posterior communicating segments)

 Life expectancy > 12 months

 Signed Informed Consent

Exclusion criteria: :

 Females who are pregnant or intend to become pregnant during the study. (Females of child-bearing potential must have a urinary pregnancy test within 7 days of enrollment)

 Extradural aneurysms

 Known multiple untreated cerebral aneurysms at study entry

 Recent history of subarachnoid hemorrhage, intracranial hemorrhage, or major surgery within one month of enrollment

 Admission platelet <50,000 or any known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy with an INR >3.0

 Contraindication to angiography such as elevated creatinine or known allergy to angiographic contrast

 Contraindication to CT and/or MRI scans

 Known allergy to the metal component of the Penumbra Liberty Stent System

 Evidence of active infection (WBC >10x109 /L)

 Any medical conditions that will not allow the necessary follow-up for this study (e.g., pre-existing neurological or psychiatric diseases)

 Current substance-abuse /illicit drug use

 Angiographic evidence of an arterial stenosis proximal to the target lesion that could prevent device deployment

 Contraindications to study medications (heparin, aspirin, clopidogrel, and radiographic contrasts)

['Stent assisted coiling with the Liberty Stent']

['Wide-neck, Saccular Intracranial Aneurysms']

Wide-neck
Saccular Intracranial Aneurysms


PENELOPE Observational Study: Prophylaxis and Treatment of Arterial and Venous Thromboembolism

Summary: The primary objective of the study is to assess efficacy and safety of different prophylactic or therapeutic antithrombotic approaches in patients with hematologic neoplasms and platelet count <50 x109/L, including unfractionated or low molecular weight heparin, fondaparinux, anti-vitamin K agents, antiplatelet agents, novel oral anticoagulants, fibrinolytic agents, with or without a policy of platelet transfusion. Cases with arterial or venous thromboembolism managed with observation or use of vena cava filters in patients with venous thromboembolism will be included too.
Inclusion criteria: inclusion criteria:

 Potential subjects must satisfy all of the following criteria to be enrolled in the study:

 diagnosis of hematologic neoplasm (acute leukemia, myelodysplastic syndrome, lymphoma, multiple myeloma, chronic myeloid leukemia, Ph-negative chronic myeloproliferative neoplasms) independently of the stage of disease or treatment (including transplant procedures);

 platelet count <50 x109/L at the time of starting antithrombotic prophylaxis or

 platelet count <50 x109/L at the time of diagnosis of arterial or venous thromboembolism objectively proven or

 platelet count >50 x109/L at time of thrombosis but subsequent thrombocytopenia <50 x109/L while receiving antithrombotic treatment;

 diagnosis of arterial thrombosis include acute coronary syndrome, ischemic stroke (including major and minor stroke), peripheral arterial thrombosis, retinal arterial thrombosis;

 diagnosis of venous thrombosis include thrombosis of deep veins of the limbs and the abdomen, superficial veins of limbs, cerebral and splanchnic veins, retinal vein, and pulmonary embolism. Splanchnic venous thrombosis include occlusion of hepatic, portal, mesenteric, and splenic veins.

Exclusion criteria: :

 The following situations will not be criteria of inclusion neither outcomes of interest:

 transient ischemic attack without CT and/or NMR signs;

 superficial vein thrombosis without Doppler ultrasound examination showing evidence of thrombosis;

 antithrombotic prophylaxis only local for central venous lines (i.e. CVC flushing with heparin);

 occlusion of the central venous catheter (notice that CVC-related deep venous thrombosis, i.e. thrombosis of the deep veins where the central line is placed, will be a criterion of inclusion or an outcome of antithrombotic prophylaxis).

['Hematologic Neoplasm', 'Acute Leukemia', 'Myelodysplastic Syndrome', 'Lymphoma', 'Multiple Myeloma']

Hematologic Neoplasm
Acute Leukemia
Myelodysplastic Syndrome
Lymphoma
Multiple Myeloma


Duloxetine for the Treatment of Postpartum Depression

Summary: The purpose of this study is to assess whether the antidepressant, duloxetine, is equally effective as a treatment for subjects who have a Postpartum Onset Depression compared to subjects who have an onset of Major Depressive Disorder prior to delivery. The hypothesis is that duloxetine will be as effective in subjects with Postpartum Major Depressive Disorder as in subjects with a Major Depressive Disorder.
Inclusion criteria: inclusion criteria:

 adult female subjects age 18 and above if onset of depression within 4 weeks of delivery,or onset of depression antenatally either during pregnancy or before pregnancy

 must score greater than or equal to 12 on the Edinburgh Postnatal Depression Scale

 speak English or Spanish

 have access to a telephone

 provide written and verbal consent

Exclusion criteria: :

 have current or lifetime psychosis

 an unstable medical condition

 hypertension

 narrow-angle glaucoma

 liver disease

 seizure disorders

 bulimia

 anorexia

 mania

 substance abuse disorders

 have a known hypersensitivity to duloxetine or any of the active ingredients

 are in need of inpatient hospital treatment with an excluded medication

 adolescents under the age of 18

 Medication Exclusion

 other antidepressants

 antipsychotic agents

 quinolone antibiotics

 Type 1C antiarrhythmics

 daily benzodiazepines

 Treatment with a monoamine oxidase inhibitor

['Postpartum Depression', 'Major Depressive Disorder']

Postpartum Depression
Major Depressive Disorder


Effects of Phytoestrogen-rich Diets on Bone Turnover in Postmenopausal Women

Summary: Osteoporosis is a major health problem. It was hypothesized that isoflavone-containing products may be a potential alternative to HRT for preventing bone loss during the menopausal transition. We investigated whether one-year consumption of isoflavone-enriched foods affected bone mineral density, bone metabolism and hormonal status in early postmenopausal women in a randomized double-blind, placebo controlled parallel multi-centre trial.
Inclusion criteria: inclusion criteria:

 Healthy as assessed by the:

 health and lifestyle questionnaire

 physical examination

 results of the pre-study laboratory tests

 Caucasian women

 Postmenopausal (≥12 - ≤60 months since last menses), determined by

 interview

 FSH level ≥ 20 IU/l

 Body Mass Index (BMI) ≥22 - ≤29 kg/m2

 Voluntary participation

 Having given their written informed consent

 Willing to comply with the study procedures

 Willing to accept use of all nameless data, including publication and the confidential use and storage of all data

 Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned

Exclusion criteria: :

 Participation in any clinical trial including blood sampling and/or administration of products up to 90 days before Day 01 of this study

 Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of products

 Osteoporosis, determined by

 Questionnaire (spontaneous bone fractures, use of medication to treat osteoporosis)

 DXA scans of the lumbar spine between day -14 and day 1 of the study; exclusion threshold is set at -2z score of BMD

 Severe scoliosis (curvature of the spine) that could interfere with the ability of the subject to go through the DXA scanning procedure and/or with a correct reading of the DXA scans

 Having a history of medical or surgical events that may significantly affect the study outcome, including:

 surgical menopause (including hysterectomy)

 antecedents and high familiar incidence of breast and/or endometrial cancer

 gastrointestinal disease (Crohn's, short bowel syndrome, coeliac disease, gastroenteritis episodes the month before the start of the study)

 hepatic disease (acute or viral hepatitis, chronic hepatitis)

 cardiovascular disease and thrombosis

 impaired renal function

 severe immune disease

 endocrine diseases (hyperthyroidism, hyperparathyroidism, IDDM, NIDDM)

 Food allergy as reported by the subject (with special emphasis on soy products) and reported allergy for sunscreen products

 Use of concomitant medication including

 Hormonal replacement therapy (during the study and within the last 6 months before day 01 of the study)

 Current use of corticosteroids (including Aerosol therapy) or past use for more than 10 days within the last 6 months

 Osteoporosis treatment (biphosphonates, SERM's, calcitonin, injectable PTH)

 Other medications known to affect bone metabolism (statins). Use of antibiotics will be carefully recorded.

 Change in smoking habits for the last 2 months

 Alcohol consumption > 21 units (drinks)/week

 Reported unexplained weight loss or gain of > 5 % of usual body weight in the month prior to the pre-study screening

 Reported slimming or medically prescribed diet

 Professional sportswomen (> 10 hours extensive sports/week)

 Reported vegan, vegetarian, macrobiotic food intake

 Regular intake of soy based foods (>2 servings per week). Participation is possible when the subject is prepared to stop consumption from screening until the end of the study

 Taking supplements containing isoflavones, in the 3 months prior to enrolment and during the study. Subjects should not start taking calcium and vitamin D supplements during the study. However, subjects who already take calcium and vitamin D supplements should maintain this intake during the study

 Recent blood or plasma donation (<1 month prior to the start of the study)

 Not willing to stop blood or plasma donation during the study

 TNO Nutrition and Food Research personnel, their partner and their first and second generation relatives

 Not having a general practitioner

 Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health. For example, laboratory results, findings at health and lifestyle questionnaire interview, or physical examination and eventual adverse events communicated to and from their general practitioner

 Mental status incompatible with the proper conduct of the study


Cutaneous Lupus Registry

Summary: Approximately 1.4 million individuals in the United States have systemic lupus erythematosus, and about 85% of these individuals develop skin lesions at some point of their disease. Cutaneous lupus erythematosus represents the skin manifestations of systemic lupus erythematosus, and can appear in people with or without systemic lupus. It is a mentally, physically, and emotionally debilitating disease that affects both the quality of life and social well-being of those affected.~The cause of cutaneous lupus is not completely understood, but likely includes multiple factors from our genes and the environment. Multiple genetic studies with small numbers of cutaneous lupus patients have been performed to determine which genes are associated with cutaneous lupus. This study aims to accumulate even larger numbers of patients to confidently identify genes and the proteins they encode that could contribute greatly to the formation of cutaneous lupus. The discovery of these genes and proteins would help not only uncover how cutaneous lupus forms, but also improve our abilities to diagnose this disease and predict its course, and stimulate new drug development.
Inclusion criteria: inclusion criteria:

 Diagnosed with cutaneous lupus erythematosus and/or systemic lupus erythematosus by clinical, laboratory, and histopathological findings

 Ability to speak and read English or Spanish at a 6th grade reading level (a translator will be available with additional consent forms in Spanish)

 Ability to give written informed consent

Exclusion criteria: :

 Less than 18 years of age, since the characteristics of the disease in these subjects could be very different

 Due to a medication, in which its discontinuation results in the resolution of cutaneous lupus, since the characteristics of the disease in these subjects could be very different

 Medical conditions who do not warrant a skin biopsy

 Unable to give written, informed consent or undergo a skin biopsy and/or venipuncture for any other reason


Optimizing Local Anesthetic Concentration for Continuous Femoral Nerve Blocks

Summary: This is a randomized, observer-masked, controlled study. Subjects will be patients undergoing bilateral total knee arthroplasty (TKA). One side (left or right) will be randomized to one of two treatment groups: a postoperative ropivacaine concentration of 0.1% or 0.4%. The contralateral side will receive the other possible ropivacaine concentration of 0.1% or 0.4%. The basal rate and patient-controlled bolus volume will depend upon the treatment group, but the total dose of local anesthetic is the same for each. For the duration of the study, all patients will receive the current usual and customary analgesics for bilateral TKA patients. All patients will receive a ropivacaine perineural infusions initiated in the operating room and continued until at least the afternoon of postoperative day (POD) 2, as well as oral acetaminophen, a sustained-release oral opioid; and celecoxib. Rescue opioid and route of administration will be determined by pain severity using a Numeric Rating Scale of 0-10, with 0 equal to no pain and 10 being the worst imaginable pain.
Inclusion criteria: inclusion criteria:

 Primary, bilateral TKA

 Age 18 years or older

 Postoperative analgesic pain includes bilateral continuous femoral nerve blocks

Exclusion criteria: :

 Chronic, high-dose opioid use

 History of opioid abuse

 Any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles

 Pregnancy

 Incarceration

['0.1% and 0.4% perineural ropivicaine']

['Total Knee Arthroplasty', 'Knee Pain']


Clinical Predictors of Pediatric OSAHS

Summary: The purpose of this study is to develop adequate and satisfactory tools using reliable clinical and physical factors in predicting pediatric obstructive sleep apnea/hypopnea syndrome (OSAHS) and allow greater access to appropriate therapy in children.
Inclusion criteria: inclusion criteria:

 children (younger than 18 years old and older than 2 years old) with symptoms of snoring and then were confirmed to having obstructive sleep apnea/hypopnea syndrome by a comprehensive polysomnography

Exclusion criteria: :

 patients with substance abuse problems or the long-term usage of medications known to affect sleep, craniofacial abnormalities or neuromuscular disorders, Down syndrome, cerebral palsy, mucopolysaccharidoses, Prader-Willi syndrome, history of psychosis, central sleep apnea syndrome, or previous airway surgery including tonsillectomy and/or adenoidectomy were excluded from the study.


Effect of FAS and FAS Ligand Polymorphisms on Patients With Platinum-Based -Treated Malignant Pleural Mesothelioma

Summary: To Study the Effect of Polymorphisms in Fas Ligand Gene Promoter Region (rs 763110) and Fas gene (rs1800682) on Platinum-Based regimens used in treatment of malignant pleural mesothelioma (MPM)
Inclusion criteria: inclusion criteria:

 Patients with histologically confirmed Malignant Pleural Mesothelioma

 Age of 18 years or more.

 first-line chemotherapy with platinum-Based agents

Exclusion criteria: :

 history of prior malignancy.

 pregnancy or lactation or any other reason preventing him from taking platinum-Based chemotherapy (AST more than 2.5* Upper Limit of Normal or Serum bilirubin more than 1.5* Upper Limit of Normal)


Ventilator Associated Pneumonia in Taper Guard Versus Normal Tube in ICU Patients

Summary: Ventilator associated pneumonia ( VAP) adds burden to the care of the intensive care patients as they may cause the death of the patient or prolong the intensive care stay or complicate the illness in other ways. The risk of infection is dependent on the interplay between bacteria load into the lungs and the immune status. There has been a lot of focus on bacteria load reduction and this includes the use of subglottic suctioning in an attempt to reduce the amount of bacteria that may move into the lungs. The Hi Lo tubes which were designed to allow subglottic suctioning was significantly effective in reducing the incidence of ventilator associated pneumonia compared to normal tubes. A new generation of endotracheal tubes that not only incorporate subglottic suctioning but provide a more snug fit into the tracheal by a new tapering design may be even more useful to provide the solution for bacterial load reduction. Conventional tubes which may furrow on themselves to allow the creation of microchannels may aid microaspiration. The taper guard which has facilities for subglottic suctioning as well as the strategy to reduce furrowing to the minimum may be the answer to the problem of ventilator associated pneumonia. This study is to determine the extent of protection this tube has against ventilator associated pneumonia compared with conventional endotracheal tubes
Inclusion criteria: inclusion criteria:

 All adult patients above 18 years old admitted into the Intensive Care unit and who is to be intubated and likely to receive more than 72 hours of ventilation would be admitted into the trial

Exclusion criteria: :

 presence of cavitary lung disease based on chest x-ray findings,

 primary lung cancer or another metastatic malignancy to the lungs, or known or suspected viral or fungal etiology,

 pneumocystis carinii pneumonia,

 legionella OR Mycoplasma pneumonia or active tuberculosis.

['Taper Guard Endotracheal Tube', 'Conventional endotracheal tube']

Taper Guard Endotracheal Tube
Conventional endotracheal tube


Reducing Inappropriate Antibiotic Prescribing by Primary Care Clinicians

Summary: Hypotheses and Specific Aims:~The continued emergence of antibiotic-resistance in the outpatient setting underlines the need to responsibly manage antimicrobial prescribing. It is in this context that we seek to test an effective strategy for reducing the inappropriate use of antibiotics in primary care office practices. Our overall objective is to identify an effective and efficient strategy for decreasing the contribution of primary care clinicians to the emergence of antimicrobial-resistant bacteria in the community and to disseminate widely those strategies found to be effective and sustainable.~We hypothesize that implementation of a clinician decision support system, with an active education component, will reduce the inappropriate use of antibiotics in primary care office practices. Our hypothesis is based on the premise that most inappropriate prescribing is the result of multiple factors that include difficulty in distinguishing a benign, self-limited viral infection from a more serious bacterial infection; overdiagnosis of a bacterial infection in cases where there is clinical uncertainty as to the true nature of the illness; and constraints on the time available for clinicians to explain to patients the nature of the illness and the reasons an antibiotic is not indicated.~The focus of this proposal will be to compare the impact of clinical decision support and active education to no intervention for enhancing the appropriate use of antimicrobials for common outpatient infections. In this randomized control trial, primary care providers participating in the intervention arm will receive active education coupled with the implementation of a clinical decision support tool, while providers in the control arm will have no intervention. At the end of the study, providers in the control arm will receive a thorough analysis of their antibiotic prescribing patterns and suggested opportunities for improvement, as well as access to the intervention tools once the study has ended.~Our interdisciplinary team will integrate novel methods in implementation science with clinical and laboratory expertise in infectious diseases, antimicrobial stewardship, primary care, information technology, performance improvement, health services research, and biostatistics. The Specific Aims are constructed to validate our hypothesis in the primary care setting by demonstrating two results of our intervention strategy:~Reduced use of antibiotics to treat conditions for which those drugs are known not to be effective~Decreased prescribing of broad-spectrum antibiotics to treat common bacterial infections.~The degree of impact in terms of prescriptions per 100 visits for each targeted outpatient infection will be compared with active education and clinical decision support versus no intervention. The study will be able to measure the value of clinical decision support with active education that will inform future efforts in disseminating outpatient antibiotic stewardship interventions.
Inclusion criteria: inclusion criteria:

 Clinic practices within Denver Health's Webb Center for Primary Care,

 Clinic practices within the University of Colorado - Anschutz Campus: General Internal Medicine Clinic,

 Clinic practices within the High Plains Network, and

 Clinical practices within the Wilmington Health Associates System

 The antibiotic prescribing patterns of primary care clinicians in these practices will be monitored over a 2 year period. Practices must be willing to assist in tracking:

 Patient records (pediatric and adult) for conditions related to the International Classification of Diseases (ICD-9) codes associated with common infectious conditions (Upper Respiratory Infection, Acute Bronchitis, Pharyngitis, Acute Sinusitis, Otitis Media, Acute Cystitis, Cellulitis or soft tissue abscess, and Community-acquired Pneumonia) will be assessed for antibiotic prescribing,

 30-day events (hospitalizations,

 Note: Emergency Department (ED) visits, or grade 3 or grade 4 abnormalities), will also be included in this study.

Exclusion criteria: :

 1. Ob/Gyn related clinic visits will not be included in this study as these visits are not typically associated with high volumes of antibiotic prescribing for the infectious conditions of interest.

['Intervention: Education, Decision Support Tools']

Intervention: Education
Decision Support Tools

['Increased Drug Resistance', 'Infectious Diseases']

Increased Drug Resistance
Infectious Diseases


Effect of Ivabradine and Beta-blockers Combination Versus Beta-blockers Up-titration on Right Ventricular Pacing

Summary: The aim of this prospective, randomized and controlled trial is to evaluate the use of the ivabradine in combination to a low-dose of beta-blocker (bisoprolol) versus up-titration of beta-blocker (bisoprolol) to obtain heart rate (HR) control with reduction in RV pacing in single-chamber or dual chambers ICD recipients HF patients with moderate to severe left ventricular dysfunction (FE ≤ 40%) and an heart rate ≥ 70 bpm in sinus rhythm over a 12-months follow up.~Besides the investigators want to assess if the combination of ivabradine to a low-dose of beta-blocker (bisoprolol) versus up-titration of beta-blocker (bisoprolol) may determine a lower degree of left ventricular dysfunction progression, the reduction of ventricular arrhythmias burden and ICD appropriate therapy occurrence and the improvement of quality of life in ICD heart failure patients.
Inclusion criteria: inclusion criteria:

 Age ≥ 18 years.

 Patients with stable chronic heart failure implanted with mono-cameral or bicameral ICD with a home monitoring remote control.

 Moderate to severe left ventricular dysfunction (FE ≤ 40%).

 Any cause of heart failure was allowed apart congenital heart disease.

 Bicameral ICD programmed in DDD or AAI/DDD with AV interval < 300 msec.

 Rest ECG heart rate ≥70 bpm;

 Sinus rhythm.

 In therapy with low-dose of beta-blocker (bisoprolol 1,25-2,5 mg) and with the maximum dose tolerated of angiotensin-converting enzyme inhibitor or blockade of angiotensin II receptor, mineralocorticoid antagonist, antiplatelet and lipid-lowering therapy, unless contraindicated.

Exclusion criteria: :

 Inability of providing informed consent;

 Age < 18 years.

 State of pregnancy or lactation.

 Recent (<2 months) myocardial infarction;

 Contraindications to beta-blockers and ivabradine;

 Rest ECG heart rate < 70 bpm;

 No sinus rhythm.

 Administration of non-dihydropyridinic calcium channels antagonists, digitalis, class I antiarrhythmic drugs, strong inhibitors of cytochrome P450 3A4 at the time of enrollment.

['Ivabradine plus beta-blocker (bisoprolol)', 'betablocker titration']

['Heart Rate Control in ICD Patients With Heart Failure']


Postoperative Atrial Fibrillation and Long-term Survival

Summary: The aim of the investigators trial was to evaluate association between new onset postoperative atrial fibrillation (POAF) and late cardiovascular morbidity and mortality.
Inclusion criteria: inclusion criteria:

 previously cardiac operation, CABG or AVR

Exclusion criteria: :

 Previous Atrial fibrillation

['Death', 'Stroke', 'Myocardial Infarction']


Treatment of Depression in Youth With Bipolar Disorders

Summary: THIS STUDY HAS BEEN DISCONTINUED.~The study is designed to evaluate the safety and efficacy of fluoxetine for treating children and adolescents with Bipolar Disorder who are experiencing an episode of major depression while being treated with a mood stabilizer. The study involves a 2-week assessment period. Patients who are on stable, therapeutic doses of lithium or valproate and continue to have depression will be randomized to a 12-week treatment of fluoxetine or placebo. Those who respond favorably to treatment will be followed openly for an 18-week continuation phase.
Inclusion criteria: inclusion criteria:

 inclusion criteria:

 Free of manic symptoms for at least 4 weeks. Must be treated with valproate or lithium (mood stabilizers) for at least 4 weeks. Meet criteria for major depression and bipolar disorder (BP-I, BP-II, or BP-NOS). Not pregnant

Exclusion criteria: :


Magnetic Resonance Imaging to Detect Brain Damage in Patients With Multiple Sclerosis

Summary: This study will test the ability of magnetic resonance imaging (MRI) to detect damage in different parts of the brain in patients with multiple sclerosis and to see if cognitive problems in patients can be correlated with the presence of lesions or reduction in the size of certain part of the brain. Healthy subjects will also be studied to compare findings in patients with those of normal volunteers.~Healthy subjects and patients with multiple sclerosis who are between 18 and 60 years of age may be eligible for this study. Patients must not have severe clinical disability and must have been receiving and responding to Interferon beta for at least 6 months prior to enrollment. Candidates are screened with a medical history, physical examination, MRI and possibly evoked potential testing, which measures the nervous system response to visual, auditory and somatosensory stimulation.~Participants have two MRI scans within 1 week (inclusive of the one performed for screening). MRI uses a magnetic field and radio waves to obtain images of body tissues and organs. The scanner is a metal cylinder surrounded by a strong magnetic field. During the MRI, the subject lies on a table that can slide in and out of the cylinder. Participants will be tested with magnet strengths of 1.5 and 3 Tesla; the higher the Tesla, the greater the ability to see brain changes. Each scan may last up to 90 minutes. In addition to the MRI scans, participants undergo cognitive testing that measures memory and thought processes and complete forms that test and quantify fatigue level, stress, anxiety and depression
Inclusion criteria: PATIENT inclusion criteria:

 Diagnosis of relapsing remitting or secondary progressive with superimposed relapses MS.

 Age between 18 and 60, inclusive.

 EDSS between 0 and 6.5.

 Receiving treatment with Interferon beta (either 1a or 1b) at fully tolerated dose for at least 6 months prior to enrollment and with evidence of clinical efficacy (i.e. reduction or absence of clinical relapses) at the time of the enrollment.

 PATIENT
Exclusion criteria: :

 Clinical relapse at the time of the enrollment or within the previous 3 months.

 Undergoing chronic therapy with any other immunomodulatory or immunosuppressive medication (excluding standard dosages of steroids intravenously/intramuscularly injected and orally taken for the treatment of relapses) besides Interferon within the past 6 months.

 Currently taking medications used for treatment of cognition/fatigue such as Donepezil (Aricept), Modafinil (Provigil), Amantadine, or other drugs that may act as temporary stimulants or depressants for the central nervous system.

 Currently taking other medications used for symptomatic relief that may affect cognition. The study neurologist will make the determination of eligibility.

 Clinically significant medical condition that, in the opinion of the investigator, would compromise patient's safety or affect his/her MRI (e.g., diabetes mellitus, chronic hypertension, severe anemia, kidney disease, heart disease [angina, arrhythmias, congestive heart failure]).

 Pregnancy or current breastfeeding.

 Previous eye surgery of any kind.

 Inability to provide informed consent. The ability of the patients in understanding all the aspects of the protocol will be judged by the means of a questionnaire.

 Permanent tattooed makeup (eyeliner, lip, etc.) or general tattoos. Subjects with tattoos will be excluded if those are in a dangerous location in the body or made with colors whose content in iron (e.g. dark blue or dark green) cannot be definitely ruled out by the Investigators.

 Any non-organic implant or any other device such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion device, cochlear, otologic, or ear implant, transdermal medication patch (nitro, hormones) that may cause problems if removed, even temporarily, any metallic implants or objects, body piercing(s), bone/joint pin, screw, nail, plate, wire sutures or surgical staples, shunt.

 Cerebral or other aneurysm clips.

 Shrapnel or other metal imbedded in the patient's body (such as from war wounds or accidents).

 Previous work in metal fields or with machines that may have left any metallic fragments in or near patients' eyes.

 A severe auto accident in the past if it is uncertain that any metal may still be imbedded in the patient's body.

 Any psychological contraindications for MRI (e.g., suffer from claustrophobia). This will be assessed at the time when the medical history will be collected.

 Any contraindications to having study procedures done.

 HEALTHY VOLUNTEER inclusion criteria:

 Age between 18 and 60.

 Vital signs are found within the normal range at the time of the screening visit.

 HEALTHY VOLUNTEER


Double-blind Trial to Investigate Efficacy and Tolerance of Ambroxol Lozenges 20 mg in Sore Throat

Summary: The aim of this trial is to investigate the efficacy and tolerance of Ambroxol lozenges 20 mg in the treatment of sore throat in patients with acute viral pharyngitis.
Inclusion criteria: 1. Patients having a sore throat with acute viral pharyngitis. 2. Female and male ambulant patients between the ages of 18 and 65. 3. The throat pain intensity is rated at least severe on the VRS (PI). 4. Written Informed Consent is given by the patient. 5. Compliance by the patient seems guaranteed.

 Patients with symptoms of primarily bacterial pharyngitis or bacterial secondary infection (clinical findings; inter alia assessment of exudate).

 First indication of symptoms of acute pharyngitis (e.g., sore throat) occurred more than 3 days ago already.

 Counting of white blood cell in blood routine examination exceeds 10?109/L.

 Patients who suffered from acute viral or bacterial pharyngitis in the past 4 weeks.

 Broncho-motor disorders or concomitant diseases with relatively large quantities of secretion (danger of secretion blockage).

 Known hypersensitivity to Ambroxol or to auxiliary substances contained in the tablet.

 Previous and/or existing tumour condition.

 Pregnancy and/or breast-feeding.

 Alcohol, and/or drug abuse.

 Simultaneous participation in another clinical trial.
Exclusion criteria:


Using the Telephone to Improve Care in Childhood Asthma

Summary: Asthma is the most common chronic disease of childhood and a major cause of morbidity in the United States. If asthma symptoms are controlled, a child with asthma can stay well and lead a normal life. Daily use of inhaled steroids controls symptoms and reduces morbidity and emergent health care utilization in children with persistent asthma, and is safe for long-term use. However, inhaled steroids are underused in community asthma care.~The Telephone Asthma Program (TAP) is a series of brief, telephone calls with a trained coach to help the parent manage the child's asthma care. The coach will teach self-management skills, help the parent to use the child's asthma medicines effectively, provide support and remind the parent to go for follow-up care with the pediatrician. We hypothesized that the Telephone Asthma Program will reduce the incidence of acute exacerbations of asthma that require emergent care, improve the quality of life of children with asthma and their parents, and increase the daily use of inhaled steroids in children with persistent asthma. We evaluated the Telephone Asthma Program in a randomized controlled trial involving 362 children aged 5 to 12 years old cared for by community pediatricians. Eligible children were randomized to the TAP program or usual care by their pediatrician.
Inclusion criteria: inclusion criteria:

 Physician diagnosis of asthma for at least a year

 At least one acute exacerbation of asthma in past 12 months that required a visit to the emergency department, hospitalization or an unscheduled office visit for acute care and/or a course of oral steroids.

 Taking daily controller medications or symptoms consistent with persistent asthma

Exclusion criteria: :

 No phone

 Unable to speak English

 Child has another disease that requires regular monitoring by pediatrician

 A sibling is already enrolled in the study

 Child's primary asthma provider is an asthma specialist