The Influence of Beta Blocker Therapy on the Hemodynamic Response to Inotrope Infusion in Patients With Acute Decompensated Heart Failure

Summary: Purpose: To compare the hemodynamic effects of dobutamine and milrinone in hospitalized patients who are receiving Beta Blocker Participants: Patients who are admitted to the General Cardiology and Heart Failure Services at the University of North Carolina Hospitals with acute decompensated heart failure, who have maintained steady state concentrations of beta blocker therapy (carvedilol or metoprolol), and who are deemed by the health care team to require pulmonary artery catheter placement and inotropic therapy with dobutamine or milrinone by continuous infusion. Patients that are not currently receiving beta blocker therapy will be enrolled for comparative purposes; however, any patient not at steady state (on or off beta blocker therapy) will not be enrolled.~Procedures: After obtaining informed consent, patients will be assigned to the appropriate sub-study group based on beta blocker use (Study A: patients on stable doses of metoprolol and Study B: patients on stable doses of carvedilol). All patients should receive dobutamine followed by milrinone as outlined in the dosing algorithm (see inotrope dosing algorithm attached, as part of the usual standard of practice). Baseline pulmonary artery catheter hemodynamic parameters will be collected prior to administration of inotrope trial of dobutamine followed by milrinone. Hemodynamic parameters will be recorded per the dosing algorithm following initiation and dose titration. Dose titration will be determined by the health care team based upon patient response or lack thereof and tolerability. Changes in hemodynamic parameters in response to dobutamine or milrinone will be compared within study groups. Additionally, data will continue to be collected on patients receiving not beta blocker therapy for comparative purpose.
Inclusion criteria: inclusion criteria:

 Patients ≥ 18 years of age and English-speaking who are admitted to the General Cardiology or Heart Failure Services at the University of North Carolina Hospitals with acute decompensated heart failure (ADHF).

 Patients deemed by the health care team to require hemodynamic monitoring with a pulmonary artery catheter and inotropic therapy. Patients receiving at least 3 doses of continued beta blocker therapy with carvedilol, metoprolol succinate, or metoprolol tartrate and patients receiving no beta blocker therapy or have missed at least 5 doses of beta-blocker therapy.

Exclusion criteria: :

 Concomitant treatment with other beta blockers, non-selective alpha blockers (e.g. terazosin, prazosin, doxazosin), non-dihydropyridine calcium antagonists, antiarrhythmic agents except for chronic stables doses of amiodarone, dofetilide or mexiletine.

 Use of inotropes or IV vasoactive agents within 7 days or at time of enrollment Patients with hemodynamically unstable arrhythmias (e.g., Systolic Blood Pressure (SBP) < 80, Heart Rate (HR) > 110), uncorrected primary valvular disease, or current mechanical support including left ventricular assist device (LVADs), Impella devices and balloon pumps

 Patients who have missed more than 1 dose of beta blocker within 72 hours of starting inotrope

 No subjects will be excluded based upon race, gender or ethnicity.

['Acute Decompensated Heart Failure', 'Heart Failure']

Acute Decompensated Heart Failure
Heart Failure


Effects of Anti-HIV Therapy on Nervous System Function

Summary: The purpose of this study is to observe the way two different anti-HIV treatment strategies affect nerve and brain function in adults with HIV.
Inclusion criteria: inclusion criteria:

 Coenrollment in the SMART study

Exclusion criteria: :

 Unable to comply with all study requirements


Using a Motivational Interviewing (MI) Informed Text Messaging Program to Lower Blood Sugar in Diabetic Patients.

Summary: Despite advances in medical therapy for diabetes, significant numbers of patients fail to achieve adequate blood glucose control. Diabetic patients who engage in more self-care behaviors have better glycemic control, as measured by HbA1C. Patient activation, defined as the knowledge, skills, beliefs, and behaviors to manage a chronic disease, is key to the performance of these self-care behaviors.~There is a growing literature on diabetes behavioral change interventions; however interventions are often developed and implemented without consideration of patients readiness to engage in lifestyle changes. Additionally, patient-tailored interventions require intensive clinical and financial resources, making them difficult to integrate into clinical practice. Mobile text messaging (SMS) programs have been successfully used to promote smoking cessation, alcohol cessation, and weight loss in diverse patient populations. SMS interventions for diabetes have also been developed, but they have been designed primarily to provide feedback on blood glucose management, rather than to motivate behavioral change. The few studies that included motivational content as a primary feature, did not tailor their intervention to a patient's readiness for change or rigorously describe their motivational intervention, and show limited efficacy.~To address these concerns, we will perform a three-month randomized controlled pilot study to develop and test a Motivational Interviewing (MI)-informed SMS intervention tailored to patient level of activation for patients with poorly controlled type II diabetes.
Inclusion criteria: inclusion criteria:

 age 18 or older

 type II diabetes

 poorly controlled diabetes (HbA1C >8 x 2 measurements, with goal < 8)

Exclusion criteria: :

 pregnancy

 non-English speaking or reading


Goals of Care: A Nursing Home Trial of Decision Support for Advanced Dementia

Summary: This cluster randomized controlled trial is to examine whether decision support for goals of care can improve quality of communication and decision-making and improve the quality of palliative care for nursing home residents with advanced dementia.
Inclusion criteria: inclusion criteria:

 Surrogate for nursing home resident with advanced dementia, paired with resident with advanced dementia

Exclusion criteria: :

 Non-related legal surrogate without personal knowledge of resident


Diagnosing Thyroid Cancer Using a Blood Test

Summary: Thyroid cancer is a relatively rare disease but its incidence is increasing in many countries.. Early and accurate diagnosis leading to earlier treatment and intervention is recognised as a major factor in determining a good outcomes. This study will investigate new ways of diagnosing thyroid cancer from blood samples using proteomic and genetic markers. The study will take samples from patients with differentiated thyroid cancer and measure relative quantities of 1000s of proteins within the blood. These measures will be explored to see if, when used in combination they can accurately diagnose thyroid cancer. If successful this technique could be extended to routine screening and could replace more invasive tests currently used. Participants will be required to supply a small sample of blood, answer questions on their medical history and also consent for their medical records to be examined. A lifestyle questionnaire will also be supplied to each participant. In the case where a diagnosis is predicted for a condition the participant was not aware of the medical team will discuss the best interests of the patient with their GP and if required refer them to a suitable specialist. The study will run for 24 months and will routinely process around 15 and 20 participants with a history of thyroid cancer per month. All patient details will be kept confidential and only non identifiable information will leave the clinic. The work will be published and if successful will be validated on another site, commercialised and made available for routine clinical use.
Inclusion criteria: inclusion criteria:

 Age over 18 years.

 Patient has thyroid cancer.

 Patient is judged as being capable of understanding the information sheet and of giving informed consent (Mental Capacity Act 2005).

 Responsible clinician is approached and is happy for the patient to be included in the study.

Exclusion criteria: :

 Age of less than 18 years.

 Patient has additional risk infections (HIV, Hep B/C)

 Patient is involved in other medicinal or treatment based clinical trial at the time of recruitment or in the previous 4 months.


Role of USCOM in Adult Patients With Heart Failure

Summary: Objective:~The Ultrasonic Cardiac Output Monitor (USCOM) is a non-invasive, quantitative method for measuring and monitoring cardiovascular haemodynamic parameters in patients. The aims of this study are:~To investigate whether USCOM-derived haemodynamic parameters such as Cardiac output (CO), inotropy and oxygen delivery (DO2) have a role in the diagnosis of patients with a compensated heart failure syndrome (cHFS) or acute decompensated heart failure syndrome (adHFS)~To investigate whether USCOM-derived haemodynamic parameters such as CO, inotropy and DO2 correlate with heart failure staging, especially New York Heart Association (NYHA) class and American Heart Association (AHA) stage.~To investigate whether USCOM-derived haemodynamic parameters such as velocity time interval (vti), stroke volume (SV), CO, SV index (SVI), CO index (CI), inotropy and DO2 correlate with ejection fraction.~To investigate whether USCOM-derived haemodynamic variables may be used as prognostic indicators of 30-day, 6-month and 1-year Major Adverse Cardiac Events (MACE).~To evaluate the agreement between hemodynamic measurements obtained using the Ultrasonic Cardiac Output Monitor (USCOM®; USCOM Ltd., Sydney, Australia), and reference standards as determined by 2 Dimensional echocardiography (2D-echo) measurements in groups of haemodynamically stable and unstable adult patients.~Design:~This prospective observational cohort study will be conducted in the Prince of Wales Hospital in Hong Kong.~Setting and Subjects:~Patients will be screened and recruited from adult patients either scheduled for elective 2D-echo at a cardiology clinic at the Prince of Wales Hospital, or attending the emergency department at the Prince of Wales Hospital.~Interventions:~Haemodynamic measurements made using the USCOM and 2D-echo will be compared. In order to assess inter-observer variability, a second, blinded operator will repeated 15% of scans.
Inclusion criteria: inclusion criteria:

 Age ≥ 18 years, AND

 Written informed consent by patient or nearest relative where appropriate, AND Either

 Referred for echocardiography, OR

 At least one typical symptom and one typical sign consistent with possible heart failure, OR

 Healthy volunteers

Exclusion criteria: :

 Age <18 years

 Prior enrollment in study

 Patients with known or suspected pregnancy

['Ultrasonic cardiac output monitor', 'Echocardiography']

Ultrasonic cardiac output monitor
Echocardiography

['Acute Decompensated Heart Failure', 'Congestive Heart Failure Compensated']

Acute Decompensated Heart Failure
Congestive Heart Failure Compensated


Effects of Amlodipine/Benazepril in the Hypertensive African-American Population With Type 2 Diabetes Mellitus

Summary: This study evaluated the efficacy and safety of amlodipine/benazepril compared with that of enalapril in the treatment of hypertension in African-American patients with type 2 diabetes.
Inclusion criteria: inclusion criteria:

 African-American

 males and females

 current diagnosis of type 2 diabetes documented by medical history;

 mean sitting diastolic blood pressure of ≥ 90 and ≤ 110 mm Hg;

 HbA1C ≤ 9.5%

Exclusion criteria: :

 having unilateral or bilateral renal artery stenosis;

 having clinically significant cardiac dysrhythmias;

 having a significant history of coronary artery disease within the past 6 months;

 having a history or diagnosis of congestive heart failure (CHF);

 having any clinically relevant cardiac valvular disease


Radiation Therapy in Treating Patients Who Are Undergoing Surgery to Remove a Metastatic Brain Tumor

Summary: RATIONALE: Specialized radiation therapy that delivers radiation directly to the area where a tumor was surgically removed may kill any remaining tumor cells and cause less damage to normal tissue.~PURPOSE: This phase I/II trial is studying radiation therapy to see how well it works in treating patients who are undergoing surgery to remove a metastatic brain tumor.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Newly diagnosed supratentorial solitary brain metastasis by enhanced MRI or CT scan

 Resectable disease

 Histological evidence of metastatic carcinoma by intraoperative pathology

 No primary lymphoma, germ cell carcinoma, or small cell lung cancer

 PATIENT CHARACTERISTICS:

 Age

 18 and over

 Performance status

 Karnofsky 70-100%

 Life expectancy

 At least 3 months

 Hematopoietic

 Not specified

 Hepatic

 Not specified

 Renal

 Not specified

 Cardiovascular

 No uncontrolled hypertension

 No unstable angina pectoris

 No uncontrolled dysrhythmias

 Other

 Not pregnant or nursing

 Negative pregnancy test

 Fertile patients must use effective contraception

 No serious infection

 No other medical illness that would preclude study participation

 PRIOR CONCURRENT THERAPY:

 Biologic therapy

 Not specified

 Chemotherapy

 No prior temozolomide or polifeprosan 20 with carmustine implant (Gliadel® wafer) for brain metastasis

 Endocrine therapy

 Not specified

 Radiotherapy

 No prior brain radiotherapy of any kind, including local or whole brain external beam radiotherapy, brachytherapy, or stereotactic radiosurgery

 No concurrent external beam radiotherapy to the brain

 Not planning adjuvant whole brain radiotherapy after study therapy

 Surgery

 Not specified

 Other

 No other prior conventional or investigational local or systemic agents for brain metastasis
Exclusion criteria:

['conventional surgery', 'intraoperative radiation therapy']

conventional surgery
intraoperative radiation therapy


Ivabradine Versus Beta-blockers in the Treatment of Inappropriate Sinus Tachycardia

Summary: The aim of this study is to prospectively compare the effectiveness and safety of ivabradine and beta-blockers in the treatment of inappropriate sinus tachycardia.
Inclusion criteria: inclusion criteria:

 Inappropriate sinus tachycardia (HR >100 bpm at rest ECG and/or medium Holter ECG HR >90 bpm)

 Age > 18 years;

Exclusion criteria: :

 Secondary causes of sinus tachycardia;

 Structural heart diseases,

 Postural orthostatic tachycardia syndrome;

 Sinus nodal reentrant tachycardia;

 Contraindications to beta-blockers;

 Administration of beta-blockers, non-di-hydropiridinic calcium channels antagonists, class I and III anti-arrhythmic drugs or digitalis at the time of enrollment;

 Age < 18 years;

 Inability of giving informed consent;


Computer-Assisted Cognitive-Behavioral Therapy for Adolescent Depression

Summary: Background: Most adolescents suffering depression are treated in primary care clinics. Cognitive-behavior therapy (CBT) is effective in the treatment of adolescent depression. The availability of appropriately trained CBT therapist may be limited, especially in primary care clinics. One way to increase the availability of CBT is to use computer-assisted CBT (c-CBT). It can be effective in the treatment of adults, although the outcomes in adolescents remain unclear.~Purpose: The purpose of this study is to determine whether a computer-assisted cognitive-behavioral therapy is effective for the treatment of depression in adolescents between 15 and 19 years of age in 4 primary care clinics in Santiago, Chile.~Study design: A two-arm single-blind (outcomes assessor) randomized controlled trial will be carried out with 216 adolescents. The efficacy, the adherence, and acceptability of the computerized-assisted cognitive behavioral therapy will be evaluated.
Inclusion criteria: inclusion criteria:

 Beck Depression Inventory > o = 10

 Meets diagnostic criteria of a depressive disorder according Kiddie Sads Present and Lifetime Version interview (K-SADS-PL)

 Parent or caregiver giving informed consent and adolescent giving informed assent

Exclusion criteria: :

 Suicidal risk requiring in-patient care

 Bipolar Disorder

 Current substance dependence

 Current alcohol dependence

 Current psychosis

 Low intellectual abilities

 Current treatment with antidepressant and/or psychotherapy

['Computer-assisted cognitive-behavioral therapy', 'Usual care treatment']


Characteristics of Prader-Willi Syndrome and Early-onset Morbid Obesity

Summary: Prader-Willi syndrome (PWS) is a rare genetic disorder that affects about 1 in 14,000 people in the United States. As the most commonly identified genetic cause of obesity, PWS is often confused with Early-onset Morbid Obesity (EMO). Individuals with EMO show some signs of PWS, but clinically do not have PWS. The purpose of this study is to evaluate the clinical features and genetic basis of PWS and EMO, and to determine how these conditions affect a person throughout a lifetime.
Inclusion criteria: inclusion criteria:

 Individuals enrolling in the Prader-Willi syndrome group will have a confirmed diagnosis of Prader-Willi syndrome, as confirmed by molecular and cytogenetic testing

 Individuals enrolling in the Early-onset Morbid Obesity group will have a documented medical history of their weight exceeding 150% of the ideal body weight or a body mass index greater than 97% before the age of 4 years; they will also be under the age of 30 years.

Exclusion criteria: :

 Known genetic, chromosomal, or hormonal cause of cognitive impairment other than Prader-Willi syndrome


Functional Pharmacogenomics of Childhood Acute Lymphoblastic Leukemia in Taiwan

Summary: Emerging results suggest that a cure rate of nearly 90 percent will be attained in the near future. The advance was attributed to stringent application of prognostic factors for risk factor-directed therapy. Early response to treatment has greater prognostic strength than does any other biologic or clinical feature tested to dates. The measurement of minimal residual disease(MRD) affords a level of sensitivity and specificity that cannot be attained through traditional microscopic morphologic assessments. In Taiwan, detection for the most recurrent fusion genes and the MRD were not commonly available, the TPOG(Taiwan Pediatric Oncology Group) used clinical features, immunophenotypes, and cytogenetics to do risk group classifications and protocol assignment. A successful rate of 60-70% has been reached. In order to improve the cure rate of ALL in Taiwan, this project aims at establishing the methods for better risk classifications and establishing MRD detection for risk-directed therapy for childhood ALL in Taiwan.Intrinsic and acquired resistances to multiple anticancer agents represent major obstacles and accounts for 10-20% of treatment failure in the developed countries nowadays. Recent progress using DNA microarray identified differential expression level of the genes known to implicate in cell cycle control, DNA repair and apoptosis in different subsets of ALL patients, which were found to be related to drug response. Genetic polymorphisms in the genes of drug-metabolizing enzymes, drug transporters or drug targets, can influence the efficacy or toxicity of antileukemic agents. Specific genotype might be important in determining the pharmacokinetic effects of one population or disease subtype from that in others. Recently, the expression profiles of relatively few microRNAs (miRNAs) (~200 genes), was noted to accurately classify human cancers. These informations hinted that expression of the genes in the leukemic cells might serve as additional risk factors for treatment stratification.~Specific aims and goals:~to establish better risk factors classification and use MRD to monitor early response to treatment.~to establish the expression profiles of 12 genes associated with drug resistance~to unravel the pharmacogenetic background of pediatric ALL in Taiwan, so that will help refine the therapy dose, achieve a better drug effect and avoid acute or chronic toxicity.~microRNA expression profiles in childhood ALL in Taiwan
Inclusion criteria: inclusion criteria:

 ALL, healthy
Exclusion criteria:


Stenting of Renal Artery Stenosis in Coronary Artery Disease Study

Summary: The Stenting of Renal Artery Stenosis in Coronary Artery Disease (RASCAD) study is a randomized controlled trial designed to evaluate the effect of renal artery stenting+medical therapy versus medical therapy alone on left ventricular mass progression and cardiovascular morbidity and mortality in patients affected by coronary artery disease and renal artery stenosis.
Inclusion criteria: inclusion criteria:

 ischemic heart disease

 angiographic diagnosis of atherosclerotic RAS >50% and ≤80%

Exclusion criteria: :

 Atherosclerotic RAS>80%

 RAS secondary to fibromuscular dysplasia

 AMI

 single functioning kidney and/or sCr >4 mg/dl

 severe aortic valve stenosis

 aortic aneurism necessitating surgery

['stenting angioplasty plus medical therapy', 'Medical therapy']

['Renal Artery Stenosis', 'Left Ventricular Hypertrophy']

Renal Artery Stenosis
Left Ventricular Hypertrophy


APC-231 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) in Pediatric Patients With Strep Throat

Summary: The purpose of this study is to evaluate the efficacy and safety of APC-231 QD for 7 days in the bacteriological outcome at the Test of Cure Visit.
Inclusion criteria: inclusion criteria:

 Give informed consent, assent, and documentation of patient authorization for disclosure of study results.

 Since all patients are below the legal age of consent, assent from the patient must be obtained (as applicable following state regulations) and written informed consent obtained from the parent or legal guardian.

 Age > = 6 months -12 years.

 A clinical diagnosis of acute tonsillitis and/or pharyngitis defined as having the clinical signs and symptoms compatible with tonsillitis and/or pharyngitis, including sore throat or difficulty feeding or swallowing or irritability that suggests the presence of a sore throat with at least one of the following:

 Tonsillar or pharyngeal exudate

 Tender cervical lymph nodes

 Fever or history of fever treated with antipyretics

 Odynophagia

 Uvular edema

 Pharyngeal Erythema of moderate or greater intensity

 Elevated white blood cell (WBC) >12,000/mm3 or 10% bands

 Red tongue and prominent papillae (Strawberry tongue)

 A positive rapid screening test for S. pyogenes (enzyme immunoassay; SiGNIFY™ Strep A Test).

 Patient is an appropriate candidate for oral antibiotic therapy and can swallow the study dosage forms.

 Females must be non-lactating and:

 If of childbearing potential and sexually active, the patient must have a negative prestudy urine pregnancy test and be utilizing acceptable birth control methods throughout the study.

Exclusion criteria: :

 Chronic or recurrent (two weeks duration two times per year) odynophagia or enlarged tonsils secondary to viral or proven bacterial etiology.

 The need for hospitalization or I.V. antimicrobial therapy.

 Pharyngitis known or suspected to be due to a pathogen resistant to beta-lactam antimicrobials.

 Patients who are known carriers of S. pyogenes.

 Previous allergy, serious adverse reaction to, or intolerance to, penicillin or any other member of the beta-lactam class of antimicrobials.

 Any serious illness or concomitant condition that the investigator judges would preclude the study evaluations or make it unlikely that the course of study therapy and follow-up could be completed. This would also include:

 Any rapidly progressive underlying disease with a shortened life expectancy.

 The inability to swallow the study dosage form.

 Unable to understand the requirements of the study.

 Neutropenia (<1000 PMNs/mm3) or other known immunocompromised state.

 Hard chills or rigors.

 Seizure disorder or lowered seizure threshold. This does not exclude children with previous febrile seizures.

 Psychiatric condition requiring use of major tranquilizers.

 Pregnancy or nursing.

 Expectation that additional effective systemic antibacterials would be required for any condition during the duration of the study.

 Current drug or alcohol abuse.

 Receipt of any experimental drug or medical device within the previous 30 days (or are scheduled to receive any other experimental procedures during the study period).

 Previous treatment under this protocol.

 Systemic antimicrobial therapy with benzathine penicillin within 30 days or azithromycin within 14 days.

 Hospitalization within the month prior to study admission, during which antibacterial therapy was administered.

 The presence of clinically significant hematologic conditions or cardiac valvular disease.

 History of cardiovascular disease, renal disease, or neurological disease secondary to previous infection with S. pyogenes.

 Probenecid treatment or systemic steroids during the duration of the study.

['Amoxicillin Pulsatile Release Multiparticluate Sprinkle']


Chronic Obstructive Pulmonary Disease (COPD) in Patients Hospitalized for Acute Decompensated Heart Failure.

Summary: The presence of chronic obstructive pulmonary disease (COPD) would confer increased in-hospital mortality and length of hospital stay in patients with acute decompensated heart failure Assess the (1) prevalence of COPD in patients who are hospitalized for acute decompensated heart failure and (2) the association between COPD and in-hospital mortality or length of stay in this cohort.
Inclusion criteria: inclusion criteria:

 Heart failure

Exclusion criteria: :

 Ambulatory patients


Lithium in Multiple System Atrophy

Summary: The purpose of this study is to determine safety and tolerability of the treatment with lithium in Multiple System Atrophy. Moreover, clinical symptoms, neuronal loss, quality of life and depressive symptoms, will be considered to further investigate the effect of lithium therapy.
Inclusion criteria: inclusion criteria:

 Clinical diagnosis of probable MSA (Gilman, et al. 2008)

 Age ≥18, <80

Exclusion criteria: :

 Heart failure

 Liver disease

 Kidney failure

 Thyroid disease

 Sick sinus syndrome and/or significant ECG alterations

 Hyposodemia

 Treatment with diuretics

 Treatment with haloperidol and/or other antipsychotics

 Treatment with NSAIDs or corticosteroids

 Treatment with ACE inhibitors

 Treatment with aminophyllines

 Treatment with mannitol

 Pregnancy and/or breastfeeding

 Acute diseases that might interfere with the trial


Music Therapy to Restore Motor Deficits After Stroke

Summary: Motor deficits are common after stroke, being one of the major causes of disability in this population. Because of the impact that motor impairments have in the life of patients and the associated financial costs, it is a health care priority to develop effective and efficient treatments to restore motor deficits. Music-supported therapy (MST) has been recently developed to enhance the use of the affected extremity after stroke.~In the present project, a new multidisciplinary approach (neurology, neuropsychology, music and cognitive neurosciences) will be undertaken in order to investigate the effectiveness of MST as a neurorehabilitation technique to restore the motor function in stroke patients. In addition, the complex pattern of reorganization of the sensorimotor system will be studied in order to provide information about the physiological mechanisms underlying the neurorehabilitation process.~A randomized controlled trial is proposed to compare for first time the effectiveness of MST (at the hospital and at home) compared to conventional treatment in subacute stroke patients suffering from motor deficits. Our hypothesis is that patients will experience a large improvement in the functional use of the affected arm due to the implementation of the MST program when compared to conventional treatment. We also expect to observe improvements in cognitive functions, mood and quality of life. Besides, we hypothesize that these amelioration in motor and cognitive domains will be accompanied by neuroplastic changes in the sensorimotor cortex and corticospinal tract.
Inclusion criteria: inclusion criteria:

 Motor deficits of the upper limb after a first ever stroke

 A minimum punctuation of 11 in the subtest from the Motricity Index and Trunk Control Test which evaluates grip and pinch

 Less than 6 months from stroke

 Age between 30 and 75 years

 Right-handed

Exclusion criteria: :

 Inability to speak and understand the Spanish or Catalan language

 Major cognitive impairment affecting comprehension

 Neurological or psychiatric co-morbidity

 Substance abuse

 Formal musical education (i.e. professional musicians)

 Metallic implants incompatible with neuroimaging assessment

 Withdrawal from the study:

 Voluntary withdrawal of consent

 A new episode of stroke during the participation in the study

['Music-supported Therapy', 'home-based Music-supported Therapy', 'Conventional treatment']

Music-supported Therapy
home-based Music-supported Therapy
Conventional treatment


A Study to Investigate the Plasma Concentration of YM150 After Repeated Administration to Elderly Subjects

Summary: The purpose of this study is to evaluate the safety and plasma concentration change of YM150 after repeated administration to healthy elderly male and female subjects.
Inclusion criteria: inclusion criteria:

 Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations and all tests

 Body weight: male: ≥45.0 kg, <85.0 kg; female: ≥40.0 kg, <75.0 kg

 BMI (at screening): ≥17.6, <30.0

Exclusion criteria: :

 Use of any other investigational drug in another clinical study or a post-marketing clinical study within 120 days before the administration of the study drug

 Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the screening assessment.

 Any surgical intervention (including tooth extraction) or trauma within 90 days before hospitalization until the administration, or plan of any surgical intervention within 10 week after the final administration

 A deviation from the normal reference range of blood pressure, pulse rate, body temperature, or 12-lead ECG

 PT or aPTT on blood coagulation tests outside the upper or lower reference limits (PT: 9.9 to 15.4 sec.; aPTT: 22.5 to 49.5 sec.)

 Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before the study

 Concurrent or previous hepatic disease (e.g. viral hepatitis, drug-induced liver injury)

 Concurrent or previous heart disease (e.g. congestive heart failure, angina pectoris, arrhythmia requiring treatment)

 Concurrent or previous respiratory disease (e.g. serious bronchial asthma, chronic bronchitis; except for a history of childhood asthma)

 Concurrent or previous renal disease (e.g. acute renal failure, glomerulonephritis, interstitial nephritis; except for a history of calculus)

 Concurrent or previous malignant tumor

 Excessive smoking or drinking habit [measure of excessive: alcohol: average 45 g/day (a 633 mL bottle of beer contains 25 g of alcohol, and 180 mL of Japanese sake contains 22 g of alcohol), smoking: average 20 cigarettes/day]

 Previous treatment with YM150

['Healthy Elderly Subject', 'Pharmacokinetic of YM150']

Healthy Elderly Subject
Pharmacokinetic of YM150


GnRH-a and Pregnancy Rate in In Vitro Fertilization (IVF) Cycles.

Summary: The investigators attempted to establish a rationale for the Gonadotropin Releasing Hormone-agonist (GnRH-a) administration, post-laparoscopically, in women with mild endometriosis (until stage II, according to AFS) who underwent IVF-ET procedure. Since GnRH-a reduces cytokine's concentration in serum (Iwabe et al., 1998; Iwabe et al., 2003) and peritoneal fluid of women with endometriosis (Taketani et al., 1992) the investigators hypothesized that GnRH-a can reduces also cytokine's concentration in the follicular fluid and this action may improve the oocyte quality and the fertility of these women.
Inclusion criteria: inclusion criteria:

 Infertility

 Mild endometriosis (until stage II)

Exclusion criteria: :

 ovarian endometrioma > 2 cm

 FSH > 12 mIU/ml

 Mail factor infertility


A Pharmacokinetic Study of Lithium Before and During Topiramate Dosing in Bipolar Disorder Patients

Summary: The purpose of this study is to determine the initial (after 1-week of maintenance dosing) and extended (after 3-weeks of maintenance dosing) effect of topiramate, at doses up to 600 mg/day, on the steady-state pharmacokinetics (absorption, distribution and excretion of the drug by the body) of lithium carbonate in patients with bipolar disorders.
Inclusion criteria: inclusion criteria:

 Patients meeting DSM-IV criteria for either Bipolar I, Bipolar II, Cyclothymic Disorder, or Bipolar Disorder NOS

 Patients on monotherapy treatment with lithium carbonate at steady state level for a minimum of two weeks prior to study treatment assignment

 Women are postmenopausal for at least 1 year, or surgically incapable of childbearing, or practicing an acceptable method of birth control (hormonal contraception, intrauterine device, or barrier with spermicide were acceptable) and not pregnant at baseline

Exclusion criteria: :

 Patients with a history of an acquired or hereditary neurologic disease, e.g., epilepsy or significant brain trauma

 Patients on depot medications, including but not limited to haloperidol, decanoate and Depo-Provera

 Patients who had taken acetazolamide, zonisamide, triamterene, dichlorphenamide, chronic antacids, or calcium supplements, or any medication associated with nephrolithiasis (kidney stone formation) in the month prior to beginning topiramate titration


Assessing the Necessity of Prescribing Antibiotics (Clavulin or Clindamycin Versus Placebo) Post-peritonsillar Abscess Drainage

Summary: This study aims to look at the necessity for prescribing antibiotics post-drainage of peritonsillar abscesses (PTA). This will be a single-blinded randomized-control trial with two arms - patients receiving placebo versus those receiving a seven day course of oral Amoxicillin-Clavulanic acid. The main objective measure will be to assess if there is resolution of the peri-tonsillar abscess and there has been no reaccumulation. Patients will be blinded to whether they receive placebo or amoxicillin-clavulanic acid. Patients will be phoned after 7 days to assess if their symptoms have resolved via an over the phone questionnaire. Anaerobic and aerobic cultures will be obtained.
Inclusion criteria: inclusion criteria:

 Older than 18 years of age

 Diagnosed with a peritonsillar abscess that has been drained and purulence has been obtained

Exclusion criteria: :

 Pregnant

 Under the age of 18

 Bilateral peritonsillar abscesses

 Recently drained peritonsillar abscess

 Immunocomprimised

['Clavulin', 'Randomization to Placebo', 'Clindamycin']

Clavulin
Randomization to Placebo
Clindamycin


Effectiveness of Lithium and Valproate in Treating High-Risk Bipolar Disorder

Summary: This study will evaluate the effectiveness of two different mood stabilizing medications, lithium and valproate, in treating people with bipolar disorder and suicidal behavior.
Inclusion criteria: inclusion criteria:

 Current major depressive episode or mixed episode

 Bipolar disorder

 History of suicidal behavior

Exclusion criteria: :

 Requires detoxification from alcohol or other substances

 Blood pressure greater than 160/90 mm Hg

 Active medical problems

 Requires long-term antipsychotic maintenance

 Becomes manic on mood stabilizers and antidepressants

 Contraindication to the use of lithium 1 or valproate (including failure to respond)

 Failure to respond to adequate trials of paroxetine, bupropion, and venlafaxine in the 2 years prior to study entry

 Failure to respond to adequate trials of olanzapine, haloperidol, and perphenazine in the 2 years prior to study entry

 Unable or unwilling to consent to treatment

 Pregnant or lactating


The Effect of Probiotics on the Clearance of the Human Papillomavirus and on Cytological Lesions Caused by the Virus

Summary: Aim: In this project proposition the investigators would like to examine the effect of immune modulation by probiotics on the clearance of HPV-infections.~This study provides a model for viral infection but also for cancer precursors. This would be an excellent model (and the only possible short-term model) to examine an effect on cancer precursors. Cancer precursors (cytological abnormalities such as L-SIL) are a scientifically accepted surrogate endpoint for cervical cancer, for example in HPV-vaccine studies.~Research question: Does daily intake of probiotics lead to a better immune-response in HPV-infected women, i.e. does it facilitate clearance of the virus and/or regression of cytological lesions?
Inclusion criteria: inclusion criteria:

 women with a new LSIL diagnosis an HPV positivity on PAP smear

Exclusion criteria: :

 women over 65

 immunocompromised patients (because of disease or drugs)

['HPV-related Cytological Abnormalities on PAP Smear (LSIL)']


Usefulness of Neutrophil Gelatinase-associated Lipocalin(NGAL) to Confirm Acute Kidney Function Decrease of the Patients Who Had Non-cardiac Surgery

Summary: Although post-op renal function decrease is determined by serum creatinine, serum creatinine has disadvantages that it increases a long time after renal function decrease and it has various increasing time based on the level of renal function. Neutrophil Gelatinase-associated Lipocalin (NGAL's) usefulness as an evidence for acute kidney damage occurring from post-op cardiac surgery, being critical patients and contrast medium use is already proven.~But NGAL's usefulness for renal function after non-cardiac surgery is not proven and especially, NGAL's usefulness for renal injury after non-cardiac surgery in chronic renal disease patients is not proven.Therefore, the investigators will study about renal function decrease after non-cardiac surgery with NGAL and serum creatinine.
Inclusion criteria: inclusion criteria:

 43 patients who had non-cardiac surgery in Seoul Paik Hospital.

Exclusion criteria: :

 have viral hepatitis and Aspartate aminotransferase, Alanine aminotransferase > 2 time of normal level

 severe lung disease

 severe heart failure ( Ejection Fraction < 40% )

 pregnancy

['The level of NGAL after pre op,post op 4hr, post op 12hr']


The Neuromarker S-100B in Patients With Different Types of Intracranial Injury

Summary: Abstract:~The most widely studied neuro-markers in traumatic brain injury (TBI) are S100B and neurone specific enolase (NSE). S-100B is localized in astroglia. This marker is used to predict neuronal damage caused by traumatic brain injury. The investigators conduct a study to derive and validate the measurement of S-100B in serum of patients with different types traumatic brain injuries.
Inclusion criteria: inclusion criteria:

 all patients with traumatic brain injury

Exclusion criteria: :

 patients without traumatic brain injury


A Prospective, Randomized Study of Operative and Nonoperative Treatment for Primary Traumatic Patellar Dislocation

Summary: The objective of this prospective, randomized cohort study was to evaluate the clinical results between operative and nonoperative treatment of primary patellar dislocation.
Inclusion criteria: inclusion criteria:

 An acute primary traumatic patellar dislocation

Exclusion criteria: :

 Previous dislocation or subluxation of the patella

 Pre-existing ipsilateral or contralateral knee pathology

 Previous knee trauma or patellar fracture.

['proximal patellar surgery', 'Nonoperative']


Comparison of BMD Measurement by DEXA to BeamMed Speed-of-Sound Measurement at Forearm in Patients With Gaucher Disease

Summary: The purpose of this study is to compare the accuracy and comparability and secondarily to assess the values achieved by measurement of the forearm BMD by DXA and SOS by BeamMed, relative to standard DXA evaluations at the FN and LS.
Inclusion criteria: inclusion criteria:

 Age: >18

 Gaucher disease type 1

 Able to undergo a DEXA test

Exclusion criteria: :

 Minors

['BeamMed Speed-of-Sound bone strength test at forearm']


Hematopoietic Stem Cell Transplant for Sickle Cell Disease

Summary: This is a phase I/II study of patients with sickle cell disease. It aims to find out if people with sickle cell disease can be cured by changing their immune system before they have blood stem cell transplants. Doctors will give patients a new drug (fludarabine) to see if this drug changes patients immune system and reduces the patient's cells (host) from rejecting donor cells (graft) after the patient gets a Hematopoietic (blood) stem cell transplant.
Inclusion criteria: inclusion criteria:

 Patients must have one of the following inherited hemoglobin gene disorders:

 a. Hemoglobin SS

 b. Hemoglobin SC

 c. Hemoglobin S-Beta-zero-Thalassemia or

 d. Hemoglobin S-Beta-plus Thalassemia with an episode of multi-organ failure within 5 years of eligibility

 Patients must meet one of the following risk criteria:

 Low Risk (Red Light. Stop and consider therapy closely): Must have matched sibling donor grafts, failed conventional therapy as determined by the PI, and evidence for morbid disease (one of the following):

 a. 2 or more painful episode/year (requiring Emergency Department or inpatient care) x 2 years or

 b. 1 or more diagnoses of Acute Chest Syndrome within 5 years, or

 c. 2-year mortality 5-10% or

 d. Baseline LDH>600 IU or

 e. History of sepsis, with or without a WBC>13.5, or

 f. On chronic transfusions

 Moderate Risk (Yellow Light. Reasonable to proceed, but with caution): May have alternate donor grafts (haploidentical or matched unrelated donor), if MSD is not available. Must have history of high-level vasculopathy, as defined by at least one of the criteria below:

 a. Urine Albumin to Creatinine Ratio of >300mg/g or eGFR 50-90 ml/min x 2 evaluations within 3 months or

 b. History of overt clinical stroke, or progressive cerebral vasculopathy radiographically or

 c. 1 or more diagnoses of Acute Chest Syndrome, multi-organ failure, or sickle hepatopathy within 7 years, or

 d. Excessively morbid disease manifest as VOCs at a rate of 2 or more per year x 2-years or uncontolled retinal disease attributed to SCD. These patients can be considered for moderate-risk alternate donor transplants. The palliative nature of the transplant will be explicit in the consent.

 e. 2-year mortality >10-15%

 i. Baseline WBC>13.5 and on chronic transfusions or baseline LDH>600 or age >35 years old,

 ii. Baseline TRV ≥3 m/s,

 iii. Chronic transfusion therapy and age >35 years old or male gender,

 iv. Baseline LDH>600 and age >35 years old or history of sepsis

 v. History of sepsis and age >35 years old or male gender.

 f. History of multi-organ failure

 High Risk (Green light, proceed if possible): All donor types are eligible. Must have high risk disease and a >15% risk of 2-year mortality as defined by at least one of the criteria below.

 a. Baseline TRV ≥3 m/s and baseline WBC >13.5 or on chronic transfusions or history of sepsis or age >35 years old,

 b. Baseline WBC>13.5 and chronic transfusions or baseline LDH>600 or age >35 years old

 c. Age >35 years old and chronic transfusions

 To determine eligibility as a bone marrow transplant patient:

 Available suitable donor

 a. 6/6 HLA-matched sibling donor (HLA A, B, and DRB1), bone marrow only

 b. 8/8 HLA-matched unrelated donor (HLA A, B, C, DRB1), bone marrow only

 c. 4/8, 5/8, 6/8, 7/8 Haploidentical donor, bone marrow only

 Patients must have adequate hematologic, hepatic, and renal function as defined below:

 Direct bilirubin within 3 X normal institutional limits

 ALT (SGPT) < 3 X institutional upper limit of normal

 Creatinine clearance >21 mL/min/1.73 m^2 for subjects with creatinine clearance values below 50 mL/min/1.73 m^2, the principal investigator may use discretion for appropriate fludarabine dose adjustment as noted.

 Patients must have adequate pulmonary function as defined by Pulmonary function: DLCO r40% (adjusted for hemoglobin) and FEV1r50%.

 Contraception/Child Bearing The effects of Fludarabine, cytoxan, ATG, tacrolimus/sirolimus and MTX are cumulatively known to be deleterious to the health of the developing human fetus. For this reason, and because of teratogenic potential, all women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) for the duration of study participation and for 12 months after completing treatment.

 Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2

 Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria: :

 Red cell alloimmunization to a degree that precludes extended transfusion

 Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

 Subjects must not have evidence of impaired liver function due to iron overload, +/- hepatitis. Patients will be evaluated by liver consult if ferritin >1500, history of hepatitis,or ALTis ≥3 X Upper limit of normal (ULN). Recommended evaluations could include liver biopsy if there is evidence for significant hepatic iron deposition or fibrosis/cirrhosis on T2* MRI of the liver.

 eGFR <21 ml/min

 ≥2.0 liter-per-minute pm home oxygen requirement

 An estimated Left Ventricular Ejection Fraction ≤40% (echo or MUGA)

 Hepatic cirrhosis (Biopsy Proven)

 HIV positive, ineligible because of the increased risk of lethal infections when treated with marrow suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated

 Pregnant or breastfeeding women are excluded from this study because the immunomodulatory treatment, preparative regimen, and anti-GVHD therapy contain agents with the potential for teratogenic or abortifacient effects.

 Evidence of uncontrolled bacterial, viral, or fungal infections (currently taking medication and progression of clinical symptoms) within 1 month prior to starting the conditioning regimen. Patients with fever or suspected minor infection should await resolution of symptoms before starting the conditioning regimen.

 Prior allogeneic marrow or stem cell transplantation.

['Fludarabine', 'Hematopoietic Stem Cell Transplant (HSCT)']

['Sickle Cell Disease', 'Sickle Cell Anemia', 'SCD']

Sickle Cell Disease
Sickle Cell Anemia
SCD


A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency

Summary: The purpose of this study is to assess the effectiveness and safety of oral pancrelipase MT in the treatment of adult and pediatric/adolescent cystic fibrosis (CF) patients with clinical symptoms of exocrine pancreatic insufficiency (EPI).
Inclusion criteria: inclusion criteria:

 Have a diagnosis of CF documented by sweat chloride results (>60 mmol/L) and require pancreatic enzyme replacement therapy (PERT) to control clinical symptoms of EPI (nausea, vomiting, bloating, diarrhea, and abdominal pain) with a history of excess fat in the feces

 Have documentation of an abnormal COA-fat and a fecal elastase result of <100 micrograms fecal elastase/gram stool

 Must be on a stable diet and dose of pancreatic enzyme supplementation that has provided satisfactory symptom control for at least the past 1 month

Exclusion criteria: :

 No extreme physical wasting with loss of weight and muscle mass

 No severe, acute, or chronic pulmonary disease unrelated to complications of CF

 No worsening of pulmonary disease in past 30 days

 No use of drugs known to affect blood uric acid concentrations (e.g., aspirin, diflunisal, allopurinol, probenecid, thiazide diuretics, phenylbutazone, sulfinpyrazone)

 No known congenital (present at birth) abnormalities of the gastrointestinal tract, heart, or liver

 No distal intestinal obstruction syndrome (DIOS)

['Pancrease MT 10.5, or MT 21', 'Placebo for Pancrease MT 10.5 or MT 21']

Pancrease MT 10.5
or MT 21
Placebo for Pancrease MT 10.5 or MT 21

['Exocrine Pancreatic Insufficiency', 'Steatorrhea', 'Malabsorption Syndromes', 'Cystic Fibrosis']

Exocrine Pancreatic Insufficiency
Steatorrhea
Malabsorption Syndromes
Cystic Fibrosis


14729-D9831C00002- 1 Month Biopsy Study

Summary: The purpose of this study is to study histological changes, cellularity, clinical efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease
Inclusion criteria: inclusion criteria:

 Men or women 40 years or above

 FEV1 between 40 and 80% of predicted normal value post-bronchodilator

 Clinical diagnosis of COPD

Exclusion criteria: :

 Other clinically relevant disease or disorders

 Exacerbation of COPD within 30 days

['Chronic Obstructive Pulmonary Disease']


Physical Activity for Campus Employees

Summary: The aim of this pilot study is to evaluate the effects of a worksite wellness program on physical activity and cardiovascular disease risk factors among university employees. The investigators hypothesize that the proposed worksite wellness program will be effective for increasing daily physical activity and improving one or more cardiovascular disease risk factors among university employees.
Inclusion criteria: inclusion criteria:

 employee of Washington University in St. Louis

Exclusion criteria: :

 pregnancy


Mefloquine Prophylaxis in HIV-1 Individuals: a Randomized Placebo-controlled Trial

Summary: This is a randomized placebo controlled trial. Malaria chemoprophylaxis with mefloquine in asymptomatic HIV-infected adults living in a malaria endemic region of Luanshya, Zambia will be compared to a placebo control group and followed up for 18 months.
Inclusion criteria: inclusion criteria:

 Permanent residents of the Luanshya district

 Males and non pregnant adults between 18 and 50 years old.

 Having a CD4 cell count of least 350 perµL at enrolment

 HIV sero-status determined at the VCT of the health center.

 No obvious underlying disease at time of enrolment

 Signed informed consent

Exclusion criteria: :

 HIV stage III or IV following the WHO classification (see attached documents regarding policy in Zambia)

 Evidence of underlying chronic diseases (cardiac, renal, hepatic, malnutrition, TB).

 Intent to move out of the study catchment area during the study period

 History of allergy to MQ (or related drugs) or sulfa drugs

 Chorionic gonadotrophic hormone in urine or obvious pregnancy


A Study Comparing the Efficacy, Safety and Tolerability of Fixed Dose Combination (FDC) of FF/UMEC/VI With the FDC of FF/VI and UMEC/VI; Administered Once-daily Via a Dry Powder Inhaler (DPI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Summary: The study evaluates the efficacy of fluticasone furoate/umeclidinium bromide/vilanterol (FF/UMEC/VI) to reduce the annual rate of moderate and severe exacerbations compared with dual therapy of FF/VI or UMEC/VI in subjects with COPD. Published studies which assessed the use of an 'open' triple therapy (use of Inhaled Corticosteroid [ICS]/ Long-acting Muscarinic Receptor Antagonists [LAMA])/ Long Acting Beta-Agonist [LABA] delivered via multiple inhalers) in moderate-severe COPD patients, reported improvements in lung function, Health Related Quality of Life (HRQoL), hospitalization rates and rescue medication use, compared to dual therapy (ICS/LABA) or LAMA alone. These studies have also shown similar safety profile with dual or monotherapy doses for periods of up to one year. Given the clinical experience with FF, UMEC and VI, and that the associated risks with these compounds are anticipated from their known pharmacology, the potential benefit of a new therapy option in patients with moderate to severe COPD supports the further development of the closed triple combination (delivered via one inhaler). In the current study subjects meeting all inclusion/exclusion criteria will complete 2-week run-in period; 52 week treatment period and a 1-week safety follow-up period. Eligible subjects will be randomized to one of the following double-blind treatment groups FF/UMEC/VI 100 micrograms (mcg)/62.5 mcg/25 mcg once daily (QD), FF/VI 100 mcg/25 mcg QD, or UMEC/VI 62.5 mcg/25 mcg QD
Inclusion criteria: inclusion criteria:

 Informed Consent: A signed and dated written informed consent prior to study participation

 Type of subject: Outpatient

 Age: Subjects 40 years of age or older at Visit 1

 Gender: Male or female subjects. A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, > 45 years, in the absence of hormone replacement therapy OR Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to safety follow-up contact): Abstinence; Oral Contraceptive, either combined or progestogen alone; Injectable progestogen; Implants of levonorgestrel; Estrogenic vaginal ring; Percutaneous contraceptive patches; Intrauterine device (IUD) or intrauterine system (IUS); Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, documented refers to the outcome of the investigator's/designee's medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records. Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)

 COPD Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society

 Smoking History: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at screening (visit 1) [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Note: Pipe and/or cigar use cannot be used to calculate pack-year history

 Severity of COPD symptoms: A score of >=10 on the COPD Assessment Test (CAT) at screening

 Severity of COPD Disease: A post-albuterol/salbutamol FEV1/ Forced Vital Capacity (FVC) ratio of <0.70 at Screening

 Existing COPD maintenance treatment: Subject must be receiving daily maintenance treatment for their COPD for at least 3 months prior to Screening. Note: Subjects receiving only Pro re nata (PRN) COPD medications are not eligible

 History of Exacerbations: Subjects must demonstrate: a post-bronchodilator FEV1 <50% predicted normal and a documented history of >= 1 moderate or severe COPD exacerbation in the previous 12 months OR a post-bronchodilator 50% <=FEV1 < 80% predicted normal and a documented history of >= 2 moderate exacerbations or a documented history of >=1 severe COPD exacerbation (hospitalized) in the previous 12 months. Note: Percent predicted will be calculated using the European Respiratory Society Global Lung Function Initiative reference equations. Note: A documented history of a COPD exacerbation (e.g., medical record verification) is a medical record of worsening COPD symptoms that required systemic/oral corticosteroids and/or antibiotics (for a moderate exacerbation) or hospitalization (for a severe exacerbation). Prior use of antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD, such as increased dyspnea, sputum volume, or sputum purulence (color). Subject verbal reports are not acceptable

 Liver function tests: alanine aminotransferase (ALT) <2x upper limit of normal (ULN); alkaline phosphatase <=1.5xULN; bilirubin <=1.5xULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)

 French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category

Exclusion criteria: :

 Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study

 Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD)

 Alpha1-antitrypsin deficiency: Subjects with Alpha1-antitrypsin deficiency as the underlying cause of COPD

 Other respiratory disorders: Subjects with active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases

 Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening

 Risk Factors for Pneumonia: immune suppression (e.g. human immunodeficiency virus [HIV], Lupus) or other risk factors for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's Disease, Myasthenia Gravis). Patients at potentially high risk (e.g. very low BMI, severely malnourished, or very low FEV1) will only be included at the discretion of the Investigator

 Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening and at least 30 days following the last dose of oral/systemic corticosteroids (if applicable). In addition, any subject that experiences pneumonia and/or moderate or severe COPD exacerbation during the run-in period will be excluded

 Other Respiratory tract infections that have not resolved at least 7 days prior to screening

 Abnormal Chest x-ray(CXR): Chest x-ray (posteroanterior and lateral) reveals evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD, or another condition that would hinder the ability to detect an infiltrate on CXR (e.g. significant cardiomegaly, pleural effusion or scarring). All subjects will have a chest x-ray at Screening Visit 1 (or historical radiograph or computerised tomography (CT) scan obtained within 3 months prior to screening) that will be over-read by a central vendor. Note: Subjects who have experienced pneumonia and/or moderate or severe COPD exacerbation within 3 months of screening must provide a post pneumonia/exacerbation chest x-ray to be over-read by the central vendor or have a chest x-ray conducted at screening. For sites in Germany: If a chest x-ray (or CT scan) within 3 months prior to Screening (Visit 1) is not available, approval to conduct a diagnostic chest x-ray will need to be obtained from the Federal Office for Radiation Protection (Bundesamt für Strahlenschutz [BfS])

 Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study

 Unstable liver disease as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice, cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).

 Note: Chronic stable hepatitis B and C are acceptable if the subject otherwise meets entry criteria

 Unstable or life threatening cardiac disease: subjects with any of the following at Screening (Visit 1) would be excluded: Myocardial infarction or unstable angina in the last 6 months; Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months; New York Heart Association (NYHA) Class IV Heart failure

 Abnormal and clinically significant 12-Lead Electrocardiogram (ECG) finding: Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. The Principal Investigator will determine the clinical significance of each abnormal ECG finding in relation to the subject's medical history and exclude subjects who would be at undue risk by participating in the trial. An abnormal and clinically significant finding that would preclude a subject from entering the trial is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the following: atrial fibrillation (AF) with rapid ventricular rate >120 beats per minute); sustained or nonsustained ventricular tachycardia (VT); Second degree heart block Mobitz type II and third degree heart block (unless pacemaker or defibrillator had been inserted); QT interval corrected for heart rate (QTcF) >=500 milliseconds (msec) in patients with QRS <120 msec and QTcF >=530 msec in patients with QRS >=120 msec

 Contraindications: A history of allergy or hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the Investigator contraindicates study participation

 Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Subjects who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the subject has been considered cured by treatment

 Oxygen therapy: Use of long-term oxygen therapy (LTOT) described as resting oxygen therapy >3 Liter/minute (L/min) (Oxygen use =<3L/min flow is not exclusionary)

 Medication prior to spirometry: Subjects who are medically unable to withhold their albuterol/salbutamol for the 4-hour period required prior to spirometry testing at each study visit

 Pulmonary rehabilitation: Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Screening or subjects who plan to enter the acute phase of a Pulmonary Rehabilitation Program during the study. Subjects who are in the maintenance phase of a Pulmonary Rehabilitation Program are not excluded

 Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years

 Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits

 Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study

 Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or study site, or immediate family members of the aforementioned that is involved with this study

 Inability to read: In the opinion of the Investigator, any subject who is unable to read and/or would not be able to complete study related materials

 Medication prior to screening: Use of the following medications within the following time intervals prior to Screening (Visit 1) or during the study: Long term antibiotic therapy Subjects receiving antibiotics for long term therapy are not eligible for the study (Antibiotics are allowed for the short term treatment of an exacerbation or for short term treatment of other acute infections during the study); Systemic, Oral, parenteral corticosteroids 30 days (Except during the study oral/systemic corticosteroids may be used to treat COPD exacerbations/pneumonia) Intra-articular injections are allowed; Any other investigational drug (30 days or 5 half lives whichever is longer)

['fluticasone furoate (FF)', 'vilanterol (VI)', 'umeclidinium bromide (UMEC)']

fluticasone furoate (FF)
vilanterol (VI)
umeclidinium bromide (UMEC)

['Pulmonary Disease, Chronic Obstructive']


European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial

Summary: To show that the early administration of bivalirudin improves 30 day outcomes when compared to the current standard of care in participants with ST segment elevation acute coronary syndrome (STE-ACS), intended for a primary percutaneous coronary intervention (PCI) management strategy, presenting either via ambulance or to centers where PCI is not performed.
Inclusion criteria: inclusion criteria:

 The decision to randomize participants was made by a qualified physician or paramedic who was present at the time.

 Participants were included in the study if they presented either via ambulance or to a center where PCI was not performed and met all of the following criteria:

 Provided written informed consent before initiation of any study related procedures. Participants randomized in the ambulance may initially have signed an abridged version.

 Aged ≥18 years at the time of randomization.

 Had a presumed diagnosis of STE-ACS with onset of symptoms of >20 minutes and <12 hours with one or more of the following:

 ST segment elevation of ≥1 millimeters (mm) in ≥2 contiguous leads

 Presumably new left bundle branch block

 An infero-lateral myocardial infarction with ST segment depression of ≥1 mm in ≥2 of leads V1-3 with a positive terminal T wave

 All participants would proceed with emergent angiography and primary PCI if indicated <2 hours after first medical contact

Exclusion criteria: :

 Participants were excluded from the study if any of the following


An Investigation of NNC 0151-0000-0000 in Subjects With Systemic Lupus Erythematosus (SLE)

Summary: This trial is conducted in the United States of America (USA). The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and signs of bioactivity of increasing repeated doses of NNC 151-0000-0000 in subjects with Systemic Lupus Erythematosus (SLE).
Inclusion criteria: inclusion criteria:

 Diagnosis of systemic lupus erythematosus (SLE)

 Disease duration: 6 months or longer

 Stable, mild to moderately active systemic lupus erythematosus (SLE)

 Receiving stable maintenance therapy

Exclusion criteria: :

 Significant Lupus Nephritis

 Active central nervous system (CNS) disease

 Significant arterial or venous thrombosis (blood clots) within 12 months prior to trial start

 Body weight of 260 lbs/120 kg or more

 History of alcohol or substance abuse

 History of cancer

 Infections

 Viral infections: HIV, Hepatitis B or C, Epstein-Barr Virus (EBV), Cytomegalovirus (CMV), Varicella-Zoster Virus (VZV), or Herpes Simplex Virus (HSV-1 or HSV-2)

 Tuberculosis

 Severe systemic bacterial, viral or fungal infections within the past 12 months prior to trial start

 Immunosuppressive and immune modulating therapy

['Inflammation', 'Systemic Lupus Erythematosus']

Inflammation
Systemic Lupus Erythematosus


Summary: We analyze retrospectively the relationship between traditional cardiovascular risk factors as hypertension, obesity, dislipidemia and diabetes and hand or knee osteoarthritis and we compare the results with a control groups of patients with soft tissue disease with no other rheumatologic condition.
Inclusion criteria: inclusion criteria:

 Patients referred for symptomatic hand or knee osteoarthritis

 All patients referred in the same period for soft tissue disease

 > 50 years old

Exclusion criteria: :

 Any other rheumatologic condition

 secondary osteoarthritis

['Cardiovascular risk factors diagnoses collection.', 'History of cardiovascular disease', 'Cardiovascular risk factors association']

['Osteoarthritis', 'Cardiovascular Risk Factors', 'Cardiovascular Disease', 'Metabolic Syndrome']

Osteoarthritis
Cardiovascular Risk Factors
Cardiovascular Disease
Metabolic Syndrome


Different Fluidic Strategy in Patients With Acute Abdomen : The Sure Volume

Summary: Acute abdomen is the clinical manifestation of irritation of the peritoneum, due to intra-abdominal generalized infection. With the exception of the primary ones which are the result of a bacterial translocation from the gastro-intestinal tract or an abdominal contamination for hematogenous way sometimes treatable with medical therapy alone, peritonitis represents a complex condition that requires an early surgical treatment.~Mortality linked to the peritonitis is extremely high and variable between 42% and 80% when associated with a systemic framework of severe sepsis. This variability is linked to a number of risk factors, including advanced age of the patients, the presence of comorbidity, male sex, a poor nutritional status, and a number of re-operations; as well as specific characteristics related to the type of infection, the timing of surgery, the beginning of an appropriate and early antibiotic therapy.The post-operative treatment of the patient with peritonitis significantly affects the outcome of the same. The presence of peritonitis and then the seizure of large volumes of liquids and the possible state of systemic vasodilation induced by the infectious process, provide a framework of hypovolemia. There is a literature that identifies in abdominal trauma damage patient's volemic aggressive resuscitation an element of pejorative outcomes. The purpose of this work is to evaluate the clinical changes determined by a different volemic strategy.
Inclusion criteria: inclusion criteria:

 All patients with acute abdomen undergoing abdominal surgery under emergency and presenting on arrival in ICU at least a sign of bad perfusion.

Exclusion criteria: :

 Patients with chronic renal failure already receiving dialysis treatment

 Acute Coronary Syndrome (ACS) <12 months and New York Hearth Classification (NHYA ) class > 3

 Patients judged at the admission not subject to resuscitative measures for severity and comorbidity

 Patients with massive hemorrhage in operative room or in the immediate perioperative with the need for blood transfusions and abundant blood products > 5 units of Erytrocyte Concentrates (EC)

 Patients scheduled for Orthotopic Liver Transplantation (OLT)

 Patients younger than 18 years old

['Standard fluidic resuscitation.', 'Volemic small treatment']

Standard fluidic resuscitation.
Volemic small treatment


Immune Response and Cytomegalovirus in Intensive Care Unit (ICU) Patients

Summary: This prospective study evaluate the immune status of patients admitted in ICU.CMV remains dormant in the body, but in people with immune deficiency, CMV could reactivate and cause life-threatening pneumonia.
Inclusion criteria: inclusion criteria:

 Age more than 18-year-old

 Informed consent

Exclusion criteria: :

 minors,

 pregnant or lactating women,

 adults under guardianship,

 immunosuppression at the entrance to resuscitation,

 AIDS

['Sampling of blood, phenotypic analysis sub-populations NK by cytometric of stream in multiple markings', 'Sampling of blood, phenotypic analysis sub-populations NK by cytometric of stream in multiple markings']


ProspEctive First Evaluation in Chest Pain Trial

Summary: The purpose of this study is to determine the best initial test in patients admitted to the hospital complaining of chest pain.
Inclusion criteria: inclusion criteria:

 Patients with chest pain or SOB admitted for rule out acute coronary syndrome

 Age ≥45 years

 EKG non-diagnostic for acute coronary syndrome

 At least 1 set of negative troponin I

Exclusion criteria: :

 Patient with ST elevation myocardial infarction.

 Patients with non-ST elevation myocardial infarction.

 Patients with known CAD.

 Patients with serum creatinine > 1.5.

 Atrial fibrillation or marked irregular heart rhythm.

 Patients in whom heart rate cannot be controlled.

 Patient with allergies to iodinated contrast agents.

 Pregnant women

 Patients unable to give informed consent

['Coronary CT Angiography', 'Stress Test']

['Chest Pain', 'Shortness of Breath', 'Suspected Acute Coronary Syndrome']

Chest Pain
Shortness of Breath
Suspected Acute Coronary Syndrome


Efficacy and Safety of 400 μg Twice Daily of Aclidinium Bromide vs. Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Summary: The purpose of this study was to observe the Efficacy and safety of 400 μg twice daily of aclidinium bromide vs. placebo when administered to patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Inclusion criteria: inclusion criteria:

 A diagnosis of stable moderate to severe COPD as defined by GOLD (the Global Initiative for Chronic Obstructive Lung Disease) guidelines(http://www.goldcopd.org); a postbronchodilator FEV1/forced vital capacity [FVC] ratio < 70% and FEV1 ≥ 30% to <80% of the predicted value.

 Current or former cigarette smokers with a smoking history of at least 10 pack-years.

Exclusion criteria: :

 History or current diagnosis of asthma

 Patients who have been hospitalized for an acute COPD exacerbation within 3 months prior to Visit 1

 Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks before Visit 1.

 Patients with any clinically significant respiratory conditions other than COPD

['aclidinium bromide 400 μg', 'aclidinium bromide placebo']

aclidinium bromide 400 μg
aclidinium bromide placebo


Safety and Efficacy of Exjade in the Treatment of Transfusion-dependent Iron Overload in Aplastic Anemia Patients

Summary: Evaluated Exjade efficacy and safety in patients with aplastic anemia and transfusion-dependent iron overload, undergoing treatment programs of immunosuppressive treatment (Cyclosporine A) , in comparison with a group of patients undergoing treatment programs of immunosuppressive treatment (Cyclosporine A) without chelation therapy.
Inclusion criteria: inclusion criteria:

 Main diagnosis: aplastic anemia

 Absence of severe and/or uncontrolled comorbidities

 Confirmed iron overload (serum ferritin ≥ 1000 mkg/L)

 Serum creatinine is not higher than the upper limit of normal for the given age

 Absence of severe proteinuria. Protein/Creatinine ratio should be < 0.5 mg/mg

 Liver enzymes are < 5 ULN

 Completion of a scheduled cycle of immunosuppressive treatment program, with no severe infectious or generalized hemorrhagic complications

 WHO (ECOG) performance status ≤ 2

Exclusion criteria: :

 No signed informed consent form

 Patient is under 18 years old

 Severe concomitant condition

 Severe infectious and generalized haemorrhagic complication following regular planned cycle of programmed immune suppressive treatment.

 History of increased sensitivity to active substance and any other ingredient of the medicinal product.

 Creatinine clearance (CC) < 60 ml/min and/or creatinine concentration in blood serum is 2 or more times higher than upper limit of age normal by results of 2 tests at Visits 1 and 2.

 Severe liver disorders (class C by Child-Pugh scale).

 Patients with aplastic anaemia in which chelator treatment will be ineffective due to rapid progression of the disease.

 Significant proteinuria basing on protein creatinine ratio > 1.0 mg/ml in urine sample from second urination at Visits 1 and 2 (or as an alternative in 2 of 3 urine samples at screening);

 Rare hereditary disorders related to galactose intolerance, severe deficit of lactase or glucose-galactose malabsorption;

 Pregnancy, lactation;

 Level of liver enzymes higher than 5 upper limits of age normal at Visits 1 and 2.


Study to Characterize Atrial Fibrillation in CHF Patients Indicated for CRT

Summary: The purpose of the study is to characterize atrial arrhythmias in patients indicated for Cardiac Resynchronization Therapy (CRT) and to monitor changes in atrial arrhythmias while CRT is provided.
Inclusion criteria: inclusion criteria:

 Patient is willing and able to comply with the protocol

 Patient is willing to sign written informed consent

 Patient is expected to remain available for Follow-up visits

 Patient age is 18 years and older

 patient is on a stable medication regimen (including beta blockers) for at least 4 weeks prior to enrollment

 Baseline criteria: patients should meet all of the following criteria, to be determined at the baseline assessment procedure within 4 weeks prior to device implantation: - New York Heart Association functional classification III or IV

 QRS duration > 130 ms

 Left ventricular ejection fraction < 35% measured by echocardiography left ventricular end diastolic dimension > 55 mm measured by echocardiography

Exclusion criteria: :

 Patients with unstable angina or who have experienced an acute myocardial infarction or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within 3 months prior to enrollment or who are candidates for CABG or PTCA

 Patients who have experienced CVA or TIA with permanent disability within 3 months prior to enrollment

 Patient on, or anticipated to require, intravenous inotropic drug therapy

 Patients with severe primary pulmonary disease (such as cor pulmonale)

 Post heart transplant patients and patients on an urgency list for cardiac transplantation

 Supine systolic blood pressure greater than 170 mm

 Patient who are not expected to survive for 8 months of study participation due to other medical conditions

 Women who are pregnant or with child bearing potential and who are not on a reliable form of birth control

 Serum creatinine greater than 250 mol/l

 Untreated hyperthyroidism

 Patients enrolled in any concurrent (drug and/or device) study

 Patients with an existing implantable cardioverter defibrillator (ICD) or indications for an ICD including those patients with sustained VT within the previous month

 Patients with permanent atrial arrhythmias. Permanent atrial arrhythmia is defined as an arrhythmia for which any possible type of cardioversion is not considered or that is recurrent within 24 hours from an attempted cardioversion

 Patients with contraindications for implantation of a cardiac pacing device

 Patients who are already implanted with a cardiac pacing device for purposes other than Cardiac Resynchronization Therapy

['Congestive Heart Failure, Atrial Fibrillation']

Congestive Heart Failure
Atrial Fibrillation


Experimental Vaccine for Prevention of Ebola Virus Infection

Summary: This study will determine if an experimental vaccine to prevent Ebola virus infection is safe and what side effects, if any, it causes. Ebola virus infection may range from mild to severe, and may cause breathing problems, severe bleeding, kidney problems and shock that can lead to death. The vaccine used in this study contains man-made genetic material similar to one part of the Ebola virus, which is designed to stimulate an immune response to the virus. The vaccine itself cannot cause Ebola virus infection because it does not contain any Ebola virus.~Participants are assigned to one of three groups as they enter into the study. Of the first 16 people in the study, 12 receive the lowest study dose of vaccine and 4 receive placebo (an inactive substance). If this dose is safe, then of the next 16 people who enter the study, 12 receive a higher dose of the vaccine, and the remaining 4 receive placebo. If this dose is safe, the final 12 people in the last group of 16 receive the highest study dose, and 4 receive placebo. The vaccine is given as a single injection in the arm on the day of enrollment.~Participants keep a diary for 5 days, recording their temperature, symptoms and any reaction at the injection site. They call a study nurse the day after vaccination to report how they feel, and they return to the clinic approximately six times for follow-up evaluations. These visits may include a check of vital signs, physical examination, blood and urine tests, or other medical tests if needed.~...
Inclusion criteria: inclusion criteria:

 A subject must meet all of the following criteria:

 18 to 50 years old.

 Available for clinical follow-up through Week 48.

 Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.

 Complete an AoU prior to enrollment and verbalize understanding of all questions answered incorrectly.

 Able and willing to complete the informed consent process.

 Willing to donate blood for sample storage to be used for future research.

 In good general health without clinically significant medical history.

 Physical examination and laboratory results without clinically significant findings and a body mass index (BMI) less than 40 within the 28 days prior to enrollment.

 Laboratory Criteria within 28 days prior to enrollment:

 Hemoglobin greater than or equal to 11.5 g/dL for women; greater than or equal to 13.5 g/dL for men

 White blood cells (WBC) equal to 3,300-12,000 cells/mm(3)

 Differential either within institutional normal range or accompanied by site physician approval

 Total lymphocyte count greater than or equal to 800 cells/mm(3)

 Platelets equal to 125,000 - 400,000/mm(3)

 Alanine aminotransferase (ALT) less than or equal to 1.25 upper limit of normal

 Serum creatinine less than or equal to 1 x upper limits of normal (less than or equal to 1.3 mg/dL for females; less than or equal to 1.4 mg/dL for males)

 Normal urinalysis defined as negative glucose, negative or trace protein and no clinically significant blood in the urine.

 Negative FDA-approved HIV blood test, at low risk of HIV exposure as assessed by behavioral risk interview, and amenable to HIV risk reduction counseling. [Note: Results of HIV ELISA will be documented, but a negative HIV polymerase chain reaction (PCR) test result will be sufficient for eligibility screening of subjects with positive HIV ELISA that is due to prior participation in an HIV vaccine study]

 Negative hepatitis B surface antigen (HBsAg)

 Negative anti-HCV and negative hepatitis C virus (HCV) PCR.

 a PTT within institutional normal range and PT less than or equal to upper limit of institutional normal range.

 Female-Specific Criteria:

 Negative beta-HCG pregnancy test (urine or serum) for women presumed to be of reproductive potential.

 A female participant must meet one of the following criteria:

 No reproductive potential because of menopause [one year without menses] or because of a hysterectomy, bilateral oophorectomy, or tubal ligation, OR

 Participant agrees to be heterosexually inactive at least 21 days prior to enrollment and through Week 24 of the study, OR

 Participant agrees to consistently practice contraception at least 21 days prior to enrollment and through Week 24 of the study by one of the following methods:

 condoms, male or female, with or without a spermicide

 diaphragm or cervical cap with spermicide

 intrauterine device

 contraceptive pills or patch, Norplant, Depo-Provera or any other FDA-approved contraceptive method

 male partner has previously undergone a vasectomy.

Exclusion criteria: :

 A subject will be excluded if one or more of the following conditions apply.

 Women:

 Breast-feeding or planning to become pregnant during the first 24 weeks after enrollment.

 Subject has received any of the following substances:

 Ebola vaccines or any recombinant adenoviral vector vaccine in a prior clinical trial.

 Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the past six months. [Note: that use of corticosteroid nasal spray for allergic rhinitis, topical corticosteroids for an acute uncomplicated dermatitis, or short-acting beta-agonists in controlled asthmatics are not excluded.]

 Blood products within 120 days prior to HIV screening

 Immunoglobulin within 60 days prior to HIV screening

 Live attenuated vaccines within 30 days prior to initial study vaccine administration

 Investigational research agents within 30 days prior to initial study vaccine administration

 Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration

 Current anti-tuberculosis prophylaxis or therapy

 Subject has a history of any of the following clinically significant conditions:

 Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain

 Idiopathic urticaria within the past 2 years

 Autoimmune disease or immunodeficiency

 Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or parenteral corticosteroids.

 Diabetes mellitus (type I or II), with the exception of gestational diabetes.

 History of thyroidectomy or thyroid disease that required medication within the past 12 months.

 A history of hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema.

 Hypertension that is not well controlled by medication or blood pressure that is more than 145/95 at enrollment.

 Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions), significant bruising or bleeding difficulties with IM injections or blood draws, or use of anticoagulant medications.

 Malignancy that is active or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of the study.

 Seizure disorder other than: 1) febrile seizures under the age of two, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) a singular seizure not requiring treatment within the last 3 years.

 Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen.

 Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within 5 years prior to enrollment, a history of suicide plan or attempt.

 Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a subject's ability to give informed consent.

 A family history of pulmonary embolism associated with deep vein thrombosis without a known cause (such as hormonal contraceptive use or neoplasm) in a biologically related parent, sibling, child under the age of 60 years, or a family history of systemic lupus erythematosus in a biologically related parent, sibling, or child of any age.

['Ebola Hemorrhagic Fever', 'Ebola Virus Disease', 'Ebola Virus Vaccines', 'Envelope Glycoprotein, Ebola Virus', 'Filovirus']

Ebola Hemorrhagic Fever
Ebola Virus Disease
Ebola Virus Vaccines
Envelope Glycoprotein
Ebola Virus
Filovirus


ENDmetriosis and Reserve Ovarienne

Summary: Endometriosis is the ectopic implantation of endometrial glands and stroma, and can be ovarian and peritoneal (superficial or deep). There are 4 stages in endometriosis according to severity, and the stage is established on the basis of intra-operative observations. The AFSr classification is currently most used (I-IV,minimal, mild, moderate, severe). Most associated with endometriosis are subfertility and pelvic pain.~In the surgical management of deep endometriosis, the issue of fertility is pivotal. There is a higher rate of infertility in a population of women with endometriosis as compared to the general population, even though the mechanisms are not yet elucidated. Patients with deep endometriosis can be referred to the surgeon for subfertility, but even when they are referred for chronic pain, future fertility considerations are taken into account in the planning of the surgery, as the patients are often young.~It is now well documented that ovarian cystectomy is deleterious with regards to the ovarian reserve, and more so in endometriomas than in any other type of benign cysts. The ovarian reserve is the functional potential of the ovaries, reflecting the quantity and quality of remaining follicles. Studies have also relied greatly on the measure of serum anti-mullerian hormone (AMH) to evaluate the effect of cystectomy on ovarian reserve, as AMH is currently the most reliable marker to assess ovarian reserve. A significant difference was found between AMH before and following cystectomy in several studies. The deleterious effect of deep endometriosis surgery which comprises a wide dissection and adhesiolysis of the pelvis in many cases, even when no cystectomy has been performed, is therefore not entirely ruled out. To the best of our knowledge, there are no studies on the effect of deep endometriosis surgery, apart from ovarian surgery, on ovarian reserve.~Our center is very active in the laparoscopic surgical treatment of deep endometriosis, with more than 200 cases every year. The objective of this trial is to assess the effect of deep endometriosis surgery on the ovarian reserve, whether a cystectomy is performed or not, by measuring serum AMH before and after surgery, at 6 months and 1 year post-operatively.
Inclusion criteria: inclusion criteria:

 female patient between 18 and 38 years

 endometriosis stage III or IV in the AFSr classification

 laparoscopy included deep endometriosis procedures (adhesiolysis, ureterolysis, cystectomy, resection of bowel, urinary or deep peritoneal endometriosis)

 written informed consent

Exclusion criteria: :

 previous adnexectomy or adnexectomy during surgery

['Deep Endometriosis Stage III', 'Deep Endometriosis Stage IV']

Deep Endometriosis Stage III
Deep Endometriosis Stage IV


Mechanistic Study of Subclinical Hypothyroidism In the Elderly

Summary: Subclinical hypothyroidism, defined as an elevated TSH in the setting of normal thyroid hormone levels, is a common diagnosis in the elderly. The purpose of this study is to examine the hypothalamic-pituitary-thyroid axis in men and women aged 70 years and older with persistent subclinical hypothyroidism. To evaluate the mechanism behind this condition, participants will undergo thyrotropin releasing hormone stimulation testing at 3 visits: baseline and while taking two different thyroid hormone preparations, levothyroxine and liothyronine. The investigators will also assess physiologic responses to these two different thyroid hormone medications to help us understand how the thyroid works in advanced age.
Inclusion criteria: inclusion criteria:

 men and women aged 70 and older

 TSH between 4.5 and 19.9 mU/L as an outpatient

 ability to provide informed consent

Exclusion criteria: :

 Laboratory Tests:

 TSH <4.5 mU/L or >20 mU/L on repeat testing at least four weeks later or free T4 level outside the reference range

 thyroid peroxidase (TPO) antibody positive

 abnormal liver function tests (LFTs >3 x upper limit of normal)

 hemoglobin <11 g/dL

 Surgeries or Procedures:

 thyroid surgery

 pituitary surgery

 bariatric surgery

 bowel resection involving the jejunum and upper ileum

 radioactive iodine therapy

 radiation treatments to head or neck

 Medical Conditions:

 diagnosis of pituitary disease

 diagnosis of amyloidosis, sarcoidosis, hemochromatosis

 diagnosis of adrenal insufficiency

 obesity with BMI > 35 mg/kg2

 history of stroke

 chronic or ongoing angina, Class II or higher congestive heart failure, or uncontrolled hypertension with current blood pressure greater than 160/100

 diabetes mellitus with hemoglobin A1C level greater than 8.0% in the past six months

 celiac sprue, Crohn's disease, ulcerative colitis, Zollinger-Ellison syndrome

 renal insufficiency with calculated glomerular filtration rate <45 cc/min

 cognitive impairment with Mini Mental State Exam[30] <24/30

 history of any seizures

 unstable medical or psychological condition in the judgment of the principal investigator

 Medications:

 thyroid hormone preparations

 antithyroid drugs

 medications that interfere with the absorption or metabolism of thyroid hormone

 medications that interfere with the TRH stimulation test

 proton pump inhibitors

['Levothyroxine', 'Liothyronine', 'Thyrotropin-Releasing Hormone']

Levothyroxine
Liothyronine
Thyrotropin-Releasing Hormone


A New Insertion Technique for Laryngeal Mask Airway

Summary: A laryngeal mask airway (LMA) is an airway device that is commonly used and placed under general anesthesia to facilitate ventilation of the patient's lungs while anesthetized. It is similar to an endotracheal tube (a breathing tube) but is less invasive. It is also placed as a backup when the Anesthesiologist is unable to pass a breathing tube and the patient is not adequately ventilating. Unfortunately, an LMA may lead to complications similar to those of breathing tube placement, such as sore throat and hoarse voice. Previous studies have examined several variables that may affect how often complications occur; these variables include giving anti-inflammatory medications and inflating the LMA to different pressures (the working end of the LMA, which rests in the patient's throat, has a cuff that is inflated to provide a seal). We are studying the effect of the PLACEMENT TECHNIQUE on postoperative sore throat, hoarse voice, and difficulty swallowing. We will be using 3 placement techniques - the traditional placement technique, a slightly different traditional placement technique, and a new technique, abbreviated the ELLIA method. The hypothesis of this study is that a new LMA insertion technique will have no difference in postoperative pharyngolaryngeal morbidity including sore throat, dysphagia and dysphonia.
Inclusion criteria: inclusion criteria:

 ASA (American Society of Anesthesiologists patient fitness category) I, II, III

 Age 18-90

 General anesthetic for where LMA (Laryngeal Mask Airway) placement is not contraindicated will be included

Exclusion criteria: :

 Small mouth opening

 Preoperative sore throat/dysphagia/dysphonia

 Patients at increased risk for aspiration

 Morbid obesity BMI > 40

 Untreated chronic GERD

 Pregnancy

 Suspected supraglottic abnormalities

 N2O use

 Need for oral-pharyngeal suctioning

 Undergoing oral and nasal surgery

 Intubation or any oral instrumental manipulations other than

 LMA placements intraoperatively or postoperatively

['Group 1 Classic', 'Group 2 pre-inflated', 'Group 3 ELL-PIC']

Group 1 Classic
Group 2 pre-inflated
Group 3 ELL-PIC


Combination of OLMesartan and CCB or Low Dose Diuretics in High Risk Elderly Hypertensive Patients Study (COLM-Study)

Summary: The purpose of this study is to investigate which combination therapy is more effective in reducing the incidence of cardiovascular events in Japanese elderly high-risk hypertensive patients: AT1 subtype angiotensin II receptor antagonist/calcium channel blocker or AT1 subtype angiotensin II receptor antagonist/low dose diuretic.
Inclusion criteria: inclusion criteria:

 Outpatients aged 65 years or older, and less than 85 years (at the time of informed consent), regardless of sex

 Systolic blood pressure (SBP) ≥140 mmHg or diastolic blood pressure (DBP) ≥90 mmHg in a sitting position on two consecutive measurements at clinic during use of 1 or more antihypertensive medications.

 Systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥100 mmHg in a sitting position on two consecutive measurements at clinic without antihypertensive medication.

 Require at least one of the following medical history or risk factors

 Medical history

 Cerebrovascular accident: cerebral infarction, brain hemorrhage, subarachnoid hemorrhage（6 months or more prior to registration）

 Myocardial infarction, coronary revascularization (PCI or CABG) （6 months or more prior to registration）

 Angina pectoris (except for the patients having history of hospitalization within 6 months prior to registration)

 Risk factors

 Male

 Current diabetes mellitus, fasting glucose ≥ 110mg/dL or postprandial glucose ≥ 140mg/dl

 Hypercholesterolemia (Total cholesterol ≥ 260mg/dL)

 Low HDL cholesterolemia (HDL-C <40mg/dL)

 Microalbuminuria (albumin/cr ≥ 30mg/gCr) or proteinuria (protein ≥ 1＋)

 Left ventricular hypertrophy (ST-T change in the ECG and SV1＋RV5 ≥ 35mm, or left ventricular mass index: male ≥ 125 g/m2, female ≥ 110 g/m2)

Exclusion criteria: :

 Secondary hypertension or malignant hypertension

 History of cerebrovascular accident (including TIA) or myocardial infarction within 6 months before registration

 Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) done within 6 months before registration or scheduled

 History of hospitalization for angina pectoris or heart failure within 6 months before registration

 Severe heart failure (New York Heart Association [NYHA] functional class III or more severe)

 Complications of atrial fibrillation, atrial flutter or severe arrhythmia

 Severe hepatic or renal dysfunction (including current treatment of dialysis or renal dysfunction with serum creatinine ≥ 2.0mg/dL)

 Not appropriate for change to the study drugs from current therapy for concurrent disease including coronary diseases (i.e. calcium channel blockers, diuretics, etc)

 History of serious side effect from study drugs (AT1 subtype angiotensin II receptor antagonist, calcium channel blocker, diuretic)

 Life threatening condition (malignant tumor, etc)

 Not suited to be study subject judged by a study physician

['olmesartan medoxomil / amlodipine or azelnidipine', 'olmesartan medoxomil / low dose thiazide type drug']

['Hypertension', 'Cardiovascular Disease', 'Diabetes']

Hypertension
Cardiovascular Disease
Diabetes