Safety, Efficacy, and Pharmacokinetics (PK) Study of Trans Sodium Crocetinate (TSC) in Patients With Intermittent Claudication

Summary: The purpose of this study is to evaluate the safety and pharmacokinetics of multiple, once-daily, intravenous doses of trans sodium crocetinate (TSC). The effectiveness of TSC in alleviating the symptoms of intermittent claudication (IC) will also be assessed.
Inclusion criteria: inclusion criteria:

 Aged 40 or older, male or female

 6-mo. history of walking limitation or symptoms of intermittent claudication (IC) in at least 1 lower limb, severity of which has not changed in the past 3 mo. and diagnosed by principal investigator as clinically stable Fontaine Stage II peripheral artery disease (PAD)

 Diagnosis of PAD secondary to atherosclerosis

 If ankle-brachial index (ABI) is > 1.3 or cannot be measured in either leg, vascular etiology documented by toe-brachial index (TBI) ≤ 0.7 in at least 1 leg

 Claudication severity, meds. for the treatment of coronary artery disease (CAD), PAD and IC, and exercise habits should be clinically stable for 3 mo. prior to Screening (SCRN) and during study. Pt. is not likely to change smoking and/or exercise habits during study

 On an exercise treadmill test (ETT), peak walking time (PWT) of at least 1 min., but no more than 12 min. at Baseline

 Willing and able to discontinue Pletal or Trental for 21 days before SCRN and during study

 Antihypertensive therapy, cholesterol-lowering therapy, chronic oral nitrates, and diabetic therapy have been stable for 30 days prior to SCRN

 Willing and able to provide written, signed, informed consent after the nature of the study has been explained and prior to any research-related procedures

 Willing and able to comply with all study-related procedures

 Sexually active patients must use an acceptable method of contraception while participating in the study

 Females of childbearing potential must have a negative pregnancy test at SCRN and have additional pregnancy tests during the study

Exclusion criteria: :

 Pregnant or lactating

 Current or history of critical limb ischemia (CLI)

 Pts. in whom artery insufficiency in the lower extremity is the result of acute limb ischemia (ALI) or an immunological or inflammatory non-atherosclerotic disorder

 Pts. in whom walking impairment due to pain is the result of other non-atherosclerotic co-morbid conditions

 A surgical intervention to alleviate symptoms of IC or PAD-specific endovascular intervention or cardiovascular surgery within 3 mo. of SCRN

 Walking limited by reasons other than claudication

 Conditions other than IC of significant severity that could confound PWT on the ETT

 Concurrent severe congestive heart failure (CHF)

 Life-threatening ventricular arrhythmias, unstable angina, and/or myocardial infarction (MI) within 3 mo. before enrollment (ENRL)

 Coronary artery bypass grafting or percutaneous coronary intervention within 4 mo. before ENRL

 Renal and/or carotid revascularization procedure within 3 mo. of ENRL

 Transient ischemic attack (TIA) within 3 mo. before ENRL

 Deep vein thrombosis (DVT) within 3 mo. before ENRL

 Severe chronic obstructive pulmonary disease (COPD)

 Thrombocytopenia

 Undergoing hemodialysis or peritoneal dialysis

 Pts. w/immunocompromised conditions, organ transplant recipients and/or need for immunosuppressive therapy

 Neurological dementia

 Stroke

 Clinically significant electrocardiogram (ECG) change during or after ETT at SCRN or Baseline visit(s)

 Cerebrovascular infarct within 3 mo. of SCRN

 Poorly controlled type 1 or type 2 diabetes at SCRN

 History of migraine headaches within last 12 mo.

 Patients with clinically significant abnormal hematology labs or blood chemistry labs

 Body mass index > 35

 Hypertension at SCRN defined as resting BP values of > 170 mmHg systolic and/or > 110 mmHg diastolic

 Hypotension at SCRN defined as resting BP values < 100 mmHg systolic or < 55 mmHg diastolic or symptomatic hypotension

 Previous treatment with any formulation of TSC

 Known allergy or hypersensitivity to any excipient (gamma-cyclodextrin, mannitol, glycine) of TSC formulation

 Previous treatment with gene therapy or other VEGF-related treatment within 12 mo. of SCRN

 Patients with recent history of alcoholism or drug abuse, or severe emotional, behavioral, or psychiatric problems

 Patients receiving experimental medications or participating in other study using an experimental drug or procedure within 45 days prior to ENRL

['Trans sodium crocetinate (TSC)', '0.9% normal saline']

Trans sodium crocetinate (TSC)
0.9% normal saline


Interpersonal Therapy for Depression in Breast Cancer

Summary: The investigators propose a randomized clinical trial to compare the efficacy of Interpersonal Psychotherapy (IPT), Problem-Solving Therapy (PST), and Brief Supportive Psychotherapy (BSP), in improving depressive symptoms, psychosocial functioning, and quality of life among patients with breast cancer and major depressive disorder (MDD).
Inclusion criteria: inclusion criteria:

 A primary psychiatric diagnosis of Major Depressive Disorder as defined by: a score of 18 or above in the 17-item Hamilton Depression Scale; Male or female ages 18+;

 Ability to give consent

 Diagnosis of Breast Cancer

 Patients may be either English or Spanish speaking

Exclusion criteria: :

 Lifetime history of psychosis or bipolar disorder

 Patients meeting diagnostic statistic manual for mental disorder criteria for alcohol or substance use disorders who require acute detoxification.

 Current suicide risk.

 Advanced cancer or other condition that limits remaining life expectancy to less than 6 months.

 Patients who are receiving effective medication for Depression

['Interpersonal Psychotherapy', 'Problem-Solving Therapy', 'Brief Supportive Psychotherapy']

Interpersonal Psychotherapy
Problem-Solving Therapy
Brief Supportive Psychotherapy


St. John's Wort Extract LI 160 for the Treatment of Atypical Depression

Summary: The aim of tis study is to assess the efficacy and safety of Jarsin® 300 mg as an acute treatment in mild to moderate depression with atypical features.
Inclusion criteria: Main inclusion criteria:

 Mild to moderate depression (ICD-10 F32.0, F32.1) with atypical features according to DSM-IV, lasting at least 3 months

 Female and male Caucasians aged 18 to 70 years

 At least one of HAMD-28 scale items 22-26 scores >1
Exclusion criteria:


Effects of Acute Systemic Inflammation on Arterial Stiffness and Microcirculation.

Summary: This study aims to assess the effect of acute inflammation on arterial stiffness and microcirculation. Patients with severe sepsis will be compared with age-, sex- and cardiovascular risk factors-matched controls.~The primary outcome is the carotid-femoral pulse wave velocity. The other outcome measures are: systemic hemodynamics (systolic, diastolic, mean and pulse blood pressures, heart rate, cardiac output, left ventricular ejection fraction, systemic vascular resistances), central hemodynamics (aortic systolic, diastolic, mean and pulse pressures, and augmentation index), thenar tissue oxygen saturation, biological makers of inflammation (plasma fibrinogen, C-reactive protein, interleukin-6, matrix metalloproteinases -2, -9, tissue inhibitor of metalloproteinase 1), and plasma catecholamine concentrations (epinephrine, norepinephrine).
Inclusion criteria: inclusion criteria:

 Control group :

 male or female aged at least 18 years, matched on age, sex and cardiovascular risk factors (smoking, hypertension, diabetes and treated dyslipidemia) with septic patients

 Normal clinical examination and normal 12-lead ECG

 Routines biological tests in the normal range of the laboratories.

 Body mass index between 18 and 27 kg/m²

 Written informed consent

 Patients group :

 Male or female aged at least 18 years

 Severe sepsis defined by the presence of:

 a systemic inflammatory response syndrome

 the evidence of an infection

 the presence of at least one organ failure or signs of tissue hypoperfusion.

 Body mass index between 18 and 27 Kg/m²

 Written informed consent from the patients or their relatives

Exclusion criteria: :

 Control group :

 legal protection or persons deprived of liberty

 bacterial or viral infection in the month preceding inclusion

 current medication

 pregnancy or breastfeeding

 exclusion period stated on the national register for persons who participate to biomedical research

 Patients group :

 legal protection or persons deprived of liberty

 vasopressor therapy

 bacterial or viral infection in the month preceding inclusion

 known cardiomyopathy

 pregnancy or breastfeeding


Oxygen Saturation Monitoring During Surgery

Summary: Patients with Obstructive Sleep Apnea (OSA) have cyclical patterns of lower blood oxygen during sleep because of repeated episodes of upper airway obstruction that cause their breathing to stop. When these patients have surgery, anesthetic drugs may worsen these patterns of lower blood oxygen. This study monitors ten patients at high risk for OSA and ten patients at low risk for OSA during surgery. Patterns of lower oxygen saturations should arise in the high risk group but not the low risk group.
Inclusion criteria: inclusion criteria:

 Age greater than 21 years

 Patients scheduled for a procedure that requires analgesia and/or sedation by any route (intravenous, intramuscular, oral, epidural or intrathecal).

 Patients with an anticipated length of sedation greater than or equal to one hour.

 Patients in the ASA category I through III.

 Patients who only receive propofol, benzodiazepines, and opioids.

Exclusion criteria: :

 Age less than 21 years

 Patients whose room air oxygen saturation is <90%

 Patients receiving post-operative positive airway pressure support

 Previous allergic/contact reactions to adhesives

 CHF

 Moderate or severe valvular disease

 TIA/CVA

 Carotid stenosis or endarterectomy

 Anemia (HCT if available < 30%)

 Pulmonary hypertension

 Dialysis

 Pregnancy

 Patients unable to give informed consent


A Retrospective Survey of the Burden of Rotavirus Gastroenteritis (RV GE) and Nosocomial RV GE in Japan

Summary: The purpose of this study is to evaluate the epidemiology and baseline disease burden of rotavirus gastroenteritis in children < 6 years of age, in Japan.
Inclusion criteria: inclusion criteria:

 A male or female child aged <6 years at the time of admission in hospital. A child will become ineligible on the day of her/his sixth birthday.

 A subject who is hospitalized with any acute gastroenteritis or rotavirus gastroenteritis during the survey period.

Exclusion criteria: :

 Participants of any kind of rotavirus vaccine clinical trial.

['Nosocomial Rotavirus Gastroenteritis', 'Rotavirus Gastroenteritis']

Nosocomial Rotavirus Gastroenteritis
Rotavirus Gastroenteritis


Safety and Efficacy Study of a New Intermittent Pneumatic Compression Device to Treat Patients With Peripheral Arterial Disease (PAD) Stage II

Summary: The purpose of this study is to evaluate the safety and efficacy of new intermittent pneumatic compression device on initial claudication distance in patients with Peripheral Arterial Disease stage II
Inclusion criteria: inclusion criteria:

 Male or female subject 18 to 90 years, of any race.

 Patients with proven Peripheral Arterial Disease (PAD) in Doppler Ultrasound and Ankle-Brachial Pressure Index (ABPI ≤ 0.9 in one leg)

 Subject with stable (>3 month) PAD Fontaine Stage II.

 Aortoiliac vessels with no significant hemodynamic disturbances , as confirmed by recent (<30 days) clinical examination

 Subject has intermittent claudication and claudication pain of the calf

 Subject has stable intermittent claudication (>3 month and not more than one year) with initial claudication distance not more than 250 meters, as determined by treadmill test (3.2 km/h, 10% grade)

 Subject willing to participate as evidenced by signing the written informed consent.

 Treatment with Aspirin or Clopidogrel for at least 7 days

 Willingness to undergo standardized walking exercise

Exclusion criteria: :

 Ankle-Brachial Pressure Index (ABI) above 0.8 in both legs. In Diabetic patients with no compressible arteries ABI above 40 mm/Hg of the higher pressure measured in both arms.

 Inability to walk

 Chronic respiratory insufficiency (severe obstructive or restrictive)

 Coronary artery disease with angina

 Stroke, myocardial infarction or other acute vascular events in the last 3 months

 Mild-Severe congestive heart failure

 Degenerative or inflammatory hip, knee, ankle or foot joint lesions interfering with walking

 Spinal stenosis or disc lesions with lower limb motor sensory defects

 Leg trauma, limb or skin infection or edema

 Recent (6 months) abdominal, cardiothoracic, vascular or orthopedic (lower limb) surgery

 Subject after crural or pedal bypass surgery

 Subject with neuropathy

 Uncontrolled arterial hypertension

 Morbid obesity (BMI >35.0)

 Need for concomitant medication with potential vascular activity

 Routinely use of pain relief medications (i.e. NSAIDs, Narcotics etc)

 Expected weak compliance

 Subject requires surgical or endovascular intervention for PAD

 Subject has known allergy to device components (sleeve fabric).

 Subject has medical conditions that may be worsened by concomitant use of the device (i.e. recent (1 year) Deep Vein Thrombosis).

 Subject participates in any other clinical study at the same time

['AngioPress Intermittent pneumatic compression (IPC) Device', 'Medications and Standard walking exercises']


Temperature Skin Check After Cryotherapy Application

Summary: The aim of this study was to reheat the skin in different ethnic groups after application of cryotherapy.
Inclusion criteria: inclusion criteria:

 belong to ethnic groups requested

Exclusion criteria: :

 suffering any change in skin sensitivity, illness of an infectious nature or previously diagnosed diseases that respond negatively to the use of cold


A Study on the Efficacy and Safety of Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers With REGRANEX

Summary: The purpose of this study is to evaluate the efficacy and safety of REGRANEXÂ® Gel compared with placebo when applied for up to 52 consecutive weeks to recurring or non-healing ulcers of the ankle or foot related to diabetes.
Inclusion criteria: inclusion criteria:

 Diagnosis of Type I or Type II diabetes mellitus and a glycohemoglobin A1c<12%

 Minimum of one neuropathic, diabetic ulcer meeting the following criteria: stage III or IV, located on the distal lower extremity, between 1 and 15 square centimeters

 No exposed bone at the ulcer site

 No osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure

 Adequate arterial circulation to the foot

 New ulcers must be meet the following criteria: full-thickness ulcer (Stage III or IV), located on feet or ankles, no exposed bone at the ulcer site, no osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure

 Recurrent ulcers must meet the following criteria: stage II, III or IV, no exposed bone at the ulcer site, no osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure

 Females must be postmenopausal, surgically incapable of childbearing, or using an acceptable method of birth control and have negative pregnancy test

Exclusion criteria: :

 Hypersensitivity to REGRANEX® Gel or one of its components

 Presence of more than two full-thickness diabetic ulcers on either lower extremity

 presence of an active systemic or local cancer or tumor of any kind

 Use of topical antibiotics, antiseptics, enzymatic debriders, or any other agents on the selected ulcers, within the seven days preceding randomization

 Active rheumatic or collagen vascular disease or pre-existing conditions or diseases which may interfere with the evaluation of safety or efficacy of Regranex

 Systemic corticosteroid maintenance therapy, immunosuppressive or chemotherapeutic agents within 14 days prior to first study drug application or are likely to receive one of these therapies during study participation

 Radiation therapy that included the distal lower extremity, at any time in patient's life

 Charcot deformity (rocker bottom foot)

['Foot Ulcer', 'Diabetic Foot', 'Skin Ulcer', 'Diabetic Neuropathies']

Foot Ulcer
Diabetic Foot
Skin Ulcer
Diabetic Neuropathies


Nimotuzumab in Combination With Chemoradiation for Esophageal Cancer

Summary: Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The phase I study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemo-radiotherapy in patients with locally advanced esophageal cancer tumours.
Inclusion criteria: inclusion criteria:

 Informed consent form signed before performing any of the study's specific procedures.

 ECOG performance status 0-2.

 Age > 18 and < 75.

 Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, greater than or equal to 1 cm (longest diameter) by spiral computed tomography (CT) scan and MRI or greater than or equal to 2 cm by other ordinary radiographic technique.

 Histologically confirmed diagnosis of locally advanced esophageal.

 Life expectancy of more than 3 months.

 Use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy.

 No serious blood producing,abnormal function of heart,lung, liver, or kidney or immuno-deficiency

 Neutrophils ≥3×109/L, platelet count≥100×109/L and haemoglobin≥9g/dL ,Creatinine ≤ 1.5 x NUL

Exclusion criteria: :

 Previous radiotherapy or chemotherapy

 Pregnant or breast-feeding women

 Drug abuse, unhealthy drug/alcohol addiction,or virus (HIV) infection

 Evidence of distant metastasis

 Participation in other clinical trials

 Patients with aphthosis, complete obstruction, fistula or deep peptic ulcer in the esophagus, or haematemesis

 Uncontrolled psychiatric disease or seizure

 Patients not fit for the clinical trial judged by the investigators


A Prospective Study of Endothelial Dysfunction and Diabetic Foot Ulcer Risk

Summary: This project will identify risk factors for diabetic foot ulcer by studying the relationship between endothelial dysfunction and foot ulcer risk. A fundamental defect in type 1 and 2 diabetic subjects is impaired vasodilatory reserve which is reflected in the dysfunction of endothelium-dependent vasodilation. Findings thus far point to an important role of the microvasculature in the development of diabetic foot ulcer and amputation.~In this study a a well-characterized cohort of 750 diabetic veterans without foot ulcer will be followed over 3-years.
Inclusion criteria: Diabetic patients with foot ulcers
Exclusion criteria:


Galactomannan Antigen in Bronchoalveolar Lavage in the Diagnosis of Invasive Aspergillosis in Neutropenic Patients

Summary: Invasive Aspergillosis (IA) is a very serious fungal infection. Hematological patients are the most affected group. IA has a very high morbimortality due to its rapid progression and because it is very difficult to be early diagnosed. Diagnosis is used to be done too late or even post-mortem. They are two new methods (techniques) trying to make the diagnosis on an early stage: detection of Galactomannan antigen of Aspergillus species and real - time polymerase chain reaction (PCR) of its DNA in blood. IA in immunocompromised patients is mainly located in lungs, so our hypothesis is that in patients where the investigators suspect IA the investigators should find earlier Galactomannan antigen or real -time PCR of Aspergillus in respiratory samples such as bronchoalveolar lavage (BAL), and its detection could be useful for diagnosis.~Objectives: To detect Galactomannan Antigen and Real Time - PCR for Aspergillus DNA in bronchoalveolar lavage. To validate the routine utility of these tests in BAL as a diagnostic method of IA and investigate if Galactomannan Antigen and Real Time - PCR for Aspergillus DNA in bronchoalveolar lavage can optimize blood test sensibility.~Methods: Prospective study. The investigators will include 200 patients. 100 of them will be hematological patients, neutropenic and at high risk to develop an IA. The other 100 will be patients without risk or no suspicion at all of IA. The investigators will perform a BAL in all patients. And blood detection of Galactomannan Antigen in hematological patients. The investigators will perform a standard microbiological culture of BAL and Galactomannan Antigen in both samples (bronchoalveolar lavage and blood). The investigators also will carry out Real Time - PCR for Aspergillus DNA detection in bronchoalveolar lavage.~Expected results: To detect Galactomannan Antigen and Real Time - PCR for Aspergillus DNA in BAL with more specificity and making earlier diagnosis than in blood. The investigators also expect to implant these techniques in BAL in the routine for IA diagnosis in neutropenic patients.
Inclusion criteria: inclusion criteria:

 100 BAL in hematological neutropenic patients at high risk of IA, admitted to our hospital, in which we usually perform a BAL for microbiological study when they present persistent fever and an opportunist infection suspicion.

 100 BAL in patients without hematological illness and without IA suspicion, in which we perform an BAL because of another reason.

Exclusion criteria: :

 Patients without fulfilling inclusion criteria.

 Patients with some contraindication to perform a bronchoscopy.


Prevalence and Outcome of Brachial Artery Endothelial Function in Morbidly Obese Patients Undergoing Bariatric Surgery

Summary: The relation between obesity and ischemic heart disease (IHD) is under considerable debate. The reduction in all-cause mortality and, more specifically, the reduction in cardiac-related mortality seen after weight-loss surgery, may be due to regression or slowing developement of subclinical IHD. Function of cells lining the arteries (endothelium) is closely related to the state of IHD and its measurement can serve as a surrogate marker for the existence and severity of IHD. The investigators hypothesize that the prevalence of undiagnosed IHD in the morbidly obese population is high and that following surgery for weight reduction there is a halt in the progression, or even a regression in its severity.~The study includes measurement of endothelial function before and after weight-reducing surgery.
Inclusion criteria: inclusion criteria:

 Morbidly obese patients who fulfill the NIH criteria for surgical intervention.

Exclusion criteria: :

 Patients deemed unfit for surgery

 Pregnant women, or who are attempting conception.

 Subjects with any history of myocardial infarction, coronary artery bypass grafting surgery, coronary angiography with angioplasty and/or stenting, or any lesion > 50% of the coronary artery luminal diameter, cerebrovascular accident, or peripheral vascular disease with abnormal electrocardiograms and/or echocardiography.

 History of drug or alcohol abuse.

 Chronic liver disease.

['Measurement of flow mediated dilation of brachial artery.']

['Obesity, Morbid', 'Ischemic Heart Disease']


Dietary Phytoestrogens and Bone Metabolism

Summary: The purpose of this study is to determine whether dietary phytoestrogens are an effective alternative to postmenopausal exogenous estrogen replacement therapy in preventing bone loss.
Inclusion criteria: inclusion criteria:

 Postmenopausal

 Weight within 90% to 120% of ideal body weight

 12 or more months since last menstrual period

 New York Metro Area resident

Exclusion criteria: :

 History of cancer, diabetes, or heart disease

 Smoker


Glucose Metabolism Disorders and Metabolic Syndrome Before and After Primary Hip and Knee Replacement

Summary: Osteoarthritis patients undergoing primary hip and knee replacement are followed-up and changes in their glucose metabolism and other metabolic parameters (obesity, cholesterol levels) are examined. Persistent postoperative pain is examined as secondary outcome.
Inclusion criteria: inclusion criteria:

 Primary hip and knee replacement for osteoarthritis

 Enrolled previously into study NCT01021826

Exclusion criteria: :

 Arthritis other than osteoarthritis (based on study NCT01021826)

 Medication affecting glucose metabolism (excl. antidiabetic agents) (based on study NTC01021826)

 Died before follow-up phase

 Did not undergo the planned hip or knee replacement

['Hyperglycemia', 'Hypercholesterolemia', 'Persistent Postoperative Pain', 'Hip Replacement', 'Knee Replacement']

Hyperglycemia
Hypercholesterolemia
Persistent Postoperative Pain
Hip Replacement
Knee Replacement


Surveillance of Hospitalised Pneumonia and Bacterial Meningitis in Tône District, Togo, 2010-2013

Summary: The aim of this study is to estimate the burden of disease due to pneumococci, other bacteria and viruses in the African meningitis belt prior to pneumococcal conjugate vaccine introduction and to estimate the population impact of the vaccine after its implementation in 2014. In a defined population of a sanitary district in northern Togo, during the period 2010 to 2017, investigators enroll patients of all ages with suspected pneumonia requiring hospitalization or suspected bacterial meningitis. Patients are evaluated by bacteriology and molecular biology techniques on blood, cerebro-spinal fluid, nasal aspirates and by chest X-ray.
Inclusion criteria: Pneumonia surveillance:

 inclusion criteria:

 resident of Tône sanitary district - requiring hospitalisation for at least one night for clinical pneumonia syndrome

 hospitalised in a study site during the study period

Exclusion criteria: :

 absence of informed consent by patient or legal tutor

 Meningitis surveillance:

 inclusion criteria:

 resident of Tône sanitary district

 presenting clinical signs of acute bacterial meningitis

 hospitalised in a study site during the study period

['Pneumonia, Bacterial', 'Pneumonia, Viral', 'Meningitis, Bacterial']

Pneumonia Bacterial Pneumonia Viral Meningitis Bacterial


The Effect of Implementing Hyper-acute Stroke Guidelines on Decision-Making for or Against Thrombolytic Therapy for Stroke in the Emergency Department

Summary: The objective of this study is to determine if the implementation of guidelines utilizing immediate CT Perfusion and CT Angiography in addition to non-contrast CT alters (reduces or increases) the time to decision-making for or against rt-PA in acute ischemic stroke, and by extension, time to therapy in treated patients and time to transfer from the department for all patients. A secondary objective is to determine if using CTP/CTA-inclusive hyperacute stroke guidelines improves safety by decreasing symptomatic intracerebral hemorrhage and mortality in patients who receive rt-PA.
Inclusion criteria: inclusion criteria:

 Patients presenting to the emergency Signs and symptoms of acute ischemic stroke: impairment of language, motor function, cognition and/or gaze, vision or neglect.

 Patients with an NIH Stroke Scale score > 4

Exclusion criteria: :

 Age less than 19

 Patient symptomatic for greater than five hours. Intravenous thrombolytic therapy must be instituted within three hours of symptom onset in order to minimize the risk of Intracerebral or symptomatic hemorrhage; other interventions such as intra-arterial thrombolytic therapy and clot retrieval allow for a six-hour window. One hour is an achievable time for arrival to institution of therapy, therefore a five-hour limit on enrollment allows the greatest number of patients the possibility of therapy.

 Inability to verify a clear onset of symptoms. As noted, time elapsed since the patient's last known baseline state is correlated to Intracerebral and symptomatic hemorrhage, and therapy is approved only for patients with a clear time of onset.


Early Versus Interval Appendectomy for Ruptured Appendicitis in Children

Summary: The purpose of this randomized trial is to compare two commonly utilized surgical treatments for children with ruptured appendicitis: early appendectomy, versus interval appendectomy. The primary outcome measure is time away from normal activities.
Inclusion criteria: inclusion criteria:

 Clinical diagnosis of ruptured appendicitis

Exclusion criteria: :

 Inability to have usual follow up care (e.g. transient to area)

['early appendectomy', 'interval appendectomy']

early appendectomy
interval appendectomy


Diabetes and Heart Disease Risk in Blacks

Summary: It is unknown if obesity contributes to the development of heart disease in African American men and women.~This study was created to determine whether there is a relationship between sex and body size and the incidence of heart disease in African American men and women. Researchers will attempt to associate obesity with the presence of heart disease risk factors. Risk factors that will be studied include; total body fat, body fat distribution, fat content of the blood (triglyceride concentration, low density lipoproteins [LDL], and high density lipoproteins [HDL]), how fast fat is removed from the blood, and how well insulin works in the body.~Scientific studies have shown that obesity and increased levels of fat content in the blood are important risk factors for heart disease in Caucasian women. However, similar studies in African American women have failed to show the same correlation. In fact, it appears that African American women in all three body weight groupings, nonobese, overweight, and obese experience high death rates due to heart disease. In addition, prior research has shown that obese African American men tend to have elevated levels of fat in the blood while African American women have normal blood fat levels. Therefore, if high levels of triglycerides (fat found in the blood) are not seen in non-diabetic obese African American women, it cannot be considered a risk factor in this population. This suggests that studies conducted on Caucasian women may not provide insight into heart disease risk factors in African American women.~The study will take 2000 healthy non-diabetic African American men and women (ages 18-70) and body mass index 3 subgroups; nonobese, overweight and obese. Diabetes undeniably increases the risk of heart disease. Therefore patients suffering from diabetes will not be included in the study. Candidates for the study will undergo a series of tests and examinations over 2 outpatient visits. Subjects will have body fat analyses, resting energy expenditure measurements, an EKG (electrocardiogram), and specific blood tests.~Researchers believe this study will provide significant insight into the causes of obesity and heart disease in African Americans.
Inclusion criteria: IINCLUSION AND
Exclusion criteria:

 CRITERIA FOR INCLUSION:

 Ethnicity: Black

 This is a study of adult African Americans and Blacks that were born in Africa but are now living in the United States. As African American people are multi-ethnic, we will in this initial investigation, study two different groups of African American. To enroll participants must self-identify as African Americans and be born in the United States, with American born parents or be born in Africa with African born parents. In both groups we will study sex differences in the role of obesity and TG levels on cardiovascular disease. In the future, we plan to expand the study to include other groups which self-identify as African Americans (i.e.AfroCarribeans and Hispanic blacks).

 Only blacks are included in this study because the focus of this study is on gender differences in blacks in risk factors for CAD, specifically obesity, TG levels and TG related CAD risk factors. Unlike Caucasian women, premenopausal black women do not appear to be as protected from heart disease as a result of their gender. One model to study this apparent decrease in gender

 related cardioprotection in black women is to compare black men to black women. An alternative model would be to compare black women to Caucasian women. However, since the primary focus of this work is on gender differences rather than racial differences comparing black women to men is a superior model. Other racial groups do not share the loss of gender-related cardioprotection found in blacks, and have been excluded. Further the advantage of comparing black men and women is that this comparison provides a better control of dietary, cultural and genetic factors.

 Age: The age range of the participants will be between 18 and 70 years. As stated in the original protocol on page 14: Future investigations are planned which will involve similar comparisons between premenopausal and postmenopausal black women and between whites and blacks. To investigate risk for glucose intolerance, diabetes and cardiovascular risk factors, it is no longer sufficient to maintain the age range between 18 and 50 years. We need to expand to an age range with an increased prevalence of these risk factors.

 Medical History: To participate in the study subjects should identify themselves as healthy. This is important so the broadest possible sample of people will enroll. The fact that people are healthy will be confirmed by the history, physical and laboratory tests done as part of the screening visit. People with established coronary artery as evidenced by history of myocardial infarction, coronary artery bypass surgery or PTCA will be allowed to participate if they are not currently having angina.

 CRITERIA FOR EXCLUSION:

 Black Ethnicity other than American or African.

 As stated in the inclusion criteria black people are a multi-ethnic group. In this initial investigation we are focusing on African Americans who are American born and Africans living in the United States who are African born. In the future, we will expand the study to include other groups of blacks such as individuals of Afro-Caribbean and Hispanic blacks.

 Medications: People who take medications that are known to alter the parameters which are under investigation in this study will be excluded. People taking medications to treat hyperlipidemia will be included but analyses will be adjusted to take this into account. Subjects on thyroid hormone replacement will be included if their TSH is normal.

 Diabetes: Because diabetes affects insulin sensitivity and TG levels all people with diabetes even if the diabetes is controlled with diet alone will not be enrolled in the study.

 Pregnant or Breastfeeding: Women who are pregnant, breastfeeding, or have an infant that is less than four months of age will be excluded. This is because the physiologic changes associated with pregnancy, breastfeeding or recent childbirth affect the parameters under study.

 Menstrual History: Now that postmenopausal women are included, menstrual history will be taken but women with irregular menses and hysterectomy will not be excluded. Women between the ages of 40 and 55 years will have FSH checked for proper characterization. Women 56 years of age and older will be assumed to be postmenopausal. However, women on any type of injectable hormonal contraception will be excluded because hormonal contraception affects both TG levels and glucose metabolism.

['Cardiovascular Diseases', 'Diabetes', 'Obesity', 'Hypertension']

Cardiovascular Diseases
Diabetes
Obesity
Hypertension


Clinical Impact of Routine Abdominal Drainage After Laparoscopic Cholecystectomy

Summary: Patients and methods: 100 patients were included in this study. They divided into two groups, group (A) with drain and group (B) without drain. The investigators recorded the effect of drainage on, postoperative pain (Po-P) using visual analogue scale VAS at 6, 24, 48 hours and 1 week postoperative nausea/vomiting at 6, 24, 48 hours postoperative, abdominal collection, hospital stay, chest complication, and postoperative body temperature.
Inclusion criteria: inclusion criteria:

 patients with gallbladder stones and laparoscopic cholecystectomy

Exclusion criteria: :

 patients above 80 years old

 patients with acute cholecystitis

 patients with history of upper laparotomy

 patients with a hemorrhagic tendency due to cirrhosis

 patients refused to give informed consent and patients who were converted to open cholecystectomy

['intra abdominal drain', 'LC without drain']

['Abdominal Drainage', 'Laparoscopic Cholecystectomy', 'Gall Stones']

Abdominal Drainage
Laparoscopic Cholecystectomy
Gall Stones


Retrospective Treatment Pattern Survey for the Patient With and Without History of Stroke

Summary: This study will compare hypertension treatment pattern of stroke patients with non-stroke patients receiving medical care from outpatient clinics at neurology specialty centers in Korea. It will evaluate target BP achievement rate in patients with stroke compared to patients without stroke and investigate factors affecting BP target goal efficacy in these patients.
Inclusion criteria: inclusion criteria:

 Outpatients attending neurology specialty centers, either with or without history of stroke, receiving hypertension medication

Exclusion criteria: :

 Secondary hypertension patients

 Patients not receiving hypertension medication


A Safety, Efficacy and Tolerability Study in Pediatric Subjects With Asthma

Summary: A Safety, Efficacy, and Tolerability Study of Daily Dosing with Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to <48 Months with Asthma.
Inclusion criteria: inclusion criteria:

 Subject's parent/legal guardian must give written informed consent, including privacy authorization, prior to study participation. Complete documentation regarding the consent process must be recorded in the case report form (CRF) and source documentation.

 Subject's parent/legal guardian must be willing and able to comply with the study procedures and visit schedules.

 Subject, male or female, must be between the ages of birth and <48 months, exclusive, at the time of consent.

 Subjects 24 to <48 months of age must have a history of physician-diagnosed asthma (defined as at least 3 episodes of respiratory symptoms consistent with asthma symptoms including, but not limited to, cough, wheeze, or dyspnea).

 Subjects 0 to <24 months of age must have a history of 3 episodes of respiratory symptoms that in the judgement of the investigator could be consistent with asthma or reactive airways disease.

 Subject must be in good health and not affected by any other chronic conditions, including respiratory disorders other than asthma.

 In subjects with a chest radiograph (taken 12 months prior to screening visit), no evidence of any chronic cardiopulmonary condition other than asthma should be present as discerned by the Investigator.

 Subject's parent/legal guardian must be able to complete the diary cards and medical event calendars (MEC) reliably on a daily basis and understand dosing instructions and questionnaire completion.

Exclusion criteria: :

 Subject who requires or is expected to require any disallowed medications

 Subject who has participated in an investigational drug study within 30 days prior to screening, or who is currently participating in another clinical trial.

 Subject or parent/legal guardian who has daily commitments during the study that would interfere with trial measurements, compliance, or both.

 Subject who has a history of hospitalization for asthma, reactive airways disease, or bronchospasm within 4 weeks prior to screening or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial.

 Subject who has experienced significant blood loss within 60 days of study drug.

 Subject with a clinical diagnosis of cystic fibrosis.

 Subject who was born prematurely, defined as less than 38 weeks gestational age at birth, and is <1 year of age at screening

 Subject whose body weight is less than 7.0 kg at screening. This minimum weight requirement is based upon standard pediatric growth charts [CDC 2000].

 Subject with a known sensitivity to levalbuterol or racemic albuterol, or any of the excipients contained in any of these formulations.

 Subject using any prescription drug with which levalbuterol or racemic albuterol sulfate administration is contraindicated.

 Subject with a history of life-threatening asthma, defined as previous asthma episodes requiring intubation or associated with hypercapnia, respiratory arrest, or hypoxic seizures.

 Subject with clinically significant abnormalities that may interfere with the metabolism or excretion of the study drugs or study participation (eg, abnormalities of renal, hepatic, metabolic, or endocrine function).

 Subject with a history of cancer.

 Subject with any chronic or congenital cardiorespiratory condition other than asthma including, but not limited to, bronchopulmonary dysplasia, congenital heart disease, and cystic fibrosis.

 Subject affected by an upper or lower respiratory tract infection in the 3 weeks prior to screening.

 Subject with a history of ventilation for a respiratory condition occurring at or near birth, including those associated with prematurity or bronchopulmonary dysplasia. Ventilatory support for elective non-cardiopulmonary surgery is not exclusionary. - Subject with any clinically significant abnormal laboratory values (hematology, blood chemistry).

 Subject with a clinically significant abnormal 12-lead ECG that would put the subject at risk for experiencing adverse cardiac effects.

 Subject who is a relative of a staff member.

['Levalbuterol', 'Levalbuterol UDV TID', 'Placebo']

Levalbuterol
Levalbuterol UDV TID
Placebo


Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants in Panama

Summary: This study aims to estimate the effectiveness of Rotarix™ vaccine which is used nationwide as a part of the expanded program on immunization (EPI), in preventing RV SGE among hospitalised children born after 1 March 2006, which corresponds to the date of introduction of Rotarix™ in the national immunization program.
Inclusion criteria: inclusion criteria for enrolled subjects and cases :

 A male or female child born after 1 March 2006 (which corresponds to the date of introduction of Rotarix™ in the EPI) and at least 12 weeks of age.

 Subject admitted to the study hospital for SGE (refer to the glossary) during the study period.

 Onset of SGE <= 14 days prior to admission.

 Laboratory confirmed (i.e. by ELISA at the hospital laboratory) RV positive stool sample at hospital admission or during the first 48 hours of hospitalisation. Note: This criterion is applicable only for cases.

 Written informed consent obtained from the parent or guardian of the subject.

 inclusion criteria for controls:

 Admitted for non-GE causes at the same hospital as the case. Note: This criterion is applicable to hospital controls only.

 Living in the same neighbourhood as the case for at least three consecutive months. Note: This criterion is applicable to neighbourhood controls only.

 At least 12 weeks of age and being born within ± 2 weeks from the date of birth of the case. If the list of children born within ± 2 weeks is exhausted, then the range would be extended to ± 4 weeks.

 Written informed consent obtained from the parent or guardian of the child.

Exclusion criteria:  for enrolled subjects and cases:

 Subject has previously participated as case or control in this study.

 Hospitalisation is unrelated to GE.

 Onset of SGE > 48 hours after admission to the hospital (nosocomial infections).


Inflammatory Response in Appendicitis

Summary: Although the presence of SIRS has been described in patients with appendicitis, its progressive response related and together with progression of symptomatology from the onset of symptoms to diagnostic has not been characterized. Continuation of the systemic inflammation in patients with injury and infectious processes may result in multiple organ dysfunction and ultimately failure. As with any acute inflammatory condition, the patients' systemic inflammatory response to appendicitis will progress and become more intense with the passing of time. The purpose of this study is to characterize the systemic inflammatory response to appendicitis from the beginning of symptoms to diagnostic in patients with appendicitis submitted to emergency surgery.
Inclusion criteria: inclusion criteria:

 Patients with appendicitis

Exclusion criteria: :

 Any patient with immunosuppressive or immunodeppressive known pathological conditions

 Any patient with a pathological report describing a normal appendix


Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery

Summary: The purpose of this study is to evaluate the effectiveness of negative pressure incision management system (Prevena™ Incision Management System (PIMS) or ActiVAC® with the Prevena™ Dressings (Peel and Place™ or Customizable™), KCI) in the prevention of wound complications including surgical site infection (SSI) and non-infectious complications in patients undergoing vascular surgery with groin incisions.
Inclusion criteria: inclusion criteria:

 Age ≥ 18

 Patient undergoing vascular surgery that would include a groin incision as a standard part of the operation. Infrainguinal bypass including femoral popliteal/tibial/pedal artery bypass with autogenous or prosthetic conduit.

 femoral endarterectomy with or without patch angioplasty involving the common femoral artery and/or profunda and/or proximal superficial artery. The index groin may have undergone prior procedures (may be inflow or outflow for existing grafts), but the patient must have fully healed from the prior operation. May include patients with concomitant proximal and/or distal peripheral vascular intervention. The patch may be autogenous venous or arterial or prosthetic material such as bovine pericardium, dacron or polytetrafluoroethylene (PTFE). Bilateral femoral endarterectomies are eligible for enrollment. The right and left groin incision would be randomized to the same dressing which is consistent with routine clinical practice.

 Willing to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent.

Exclusion criteria: :

 Any groin incision on index leg within 12 weeks prior to treatment initiation.

 Infrainguinal bypass without a groin incision including popliteal-tibial or pedal bypass.

 Supra inguinal procedures such as open or endovascular abdominal aortic aneurysm repair or aorto-femoral/bi-femoral bypass for occlusive disease.

 Undergoing current chemotherapy or radiation therapy.

 Pregnancy or lactation.

 Inability or refusal to provide informed consent.

 Patients who received an investigational drug for peripheral arterial disease within 4 weeks of screening or who participated in another non-observational clinical trial in the prior 30 days.

 Surgical incision in the groin without primary closure including previously open or infected wounds.

 Sensitivity or allergy to silver.

 Prior enrollment in this randomized controlled trial.

['standard gauze dressing', 'Prevena Incision Management system']

standard gauze dressing
Prevena Incision Management system

['Peripheral Artery Disease', 'Critical Limb Ischemia', 'Claudication']

Peripheral Artery Disease
Critical Limb Ischemia
Claudication


Intracardiac Echocardiography in Atrial Flutter Ablation

Summary: Background: Radiofrequency ablation of typical atrial flutter present the most effective treament option in treatment of atrial flutter. Despite its high efficacy, due tovariant anatomy of cavotricuspid isthmus (CTI), i.e. location of right coronary artery, pouches, the achievment of complete bidirectional block across the CTI is sometimes chalenging. Intracardiac echocardiography (ICE) is a very usefull tool for on-line vizualization of the anatomy of the atria and also for the location of catheter position on CTI during ablation. If the routine use of ICE is associated with easier atrial fluter ablation is not clear.~Methods: One hundred consecutive patients indicated for typical atrial flutter ablation will be enrolled into the study. The patients will be randomized into group (A) ablation with use of ICE and (B) ablation without ICE. The ablation will be done in both groups by two diagnostic catheters (10-pole positioned in coronary sinus and 20-pole halo catheter positioned in the right atrium) and radiofrequency ablation catheter. The end-point of the ablation is the achievment of the bicidrectional block across the CTI. The end-points of the study are 1) the total length of the procedure, 2) the fluoroscopy time and 3) the ablation time. The safety end-point is clinically significant bleeding from the groin due to additional puncture for ICE catheter.~Discussion: We hypothesize the use of ICE wil shorten the radiofrequency energy delivery, fluoroscopy time and the length of the procedure without increasing the bleeding.
Inclusion criteria: inclusion criteria:

 indication for atrial flutter ablation

Exclusion criteria: :

 history of recent femoral vein thrombosis (within last 6 months)


Neuromuscular Electrical Stimulation in Patients With Critical Limb Ischaemia

Summary: This study will assess the benefit of a neuromuscular electrical stimulation device in patients suffering from symptoms and effects of critical limb ischaemia.
Inclusion criteria: inclusion criteria:

 Willing, able, and committed to participate in the procedures for the full length of the study.

 All ethnic groups, male or female above the age of 18 years.

 Diagnosis of non-reconstructable arterial disease and critical limb ischaemia (with a minimum of duplex ultrasound and an MDT discussion to have reached this diagnosis)

 Be of non-childbearing potential; OR using adequate contraception and have a negative urine pregnancy test result within 24 hours if appropriate before using the study device.

 Blood pressure currently under moderate control (< 160/100mmHg)

 History of uncomplicated cardiovascular events beyond 3 months.

 No current foot ulceration

Exclusion criteria: :

 Patients meeting any of the following criteria are to be excluded:

 Has an unstable condition (eg, psychiatric disorder, a recent history of substance abuse) or otherwise thought to be unreliable or incapable of complying with the study protocol.

 Has any metal implants

 Pregnant

 Has peripheral neuropathy

 Has a cardiac pacemaker or defibrillator device

 Has recent lower limb injury or lower back pain

 Has current foot ulceration or other skin ulcers

 Has foot deformities

 Has any disorder that, in the opinion of the Investigator, might interfere with the conduct of the study

 Ankle-Brachial Pressure Index >0.9

['Peripheral Arterial Disease', 'Critical Limb Ischaemia']

Peripheral Arterial Disease
Critical Limb Ischaemia


Assessment of Coronary Flow Reserve in Heart Failure Patients After Ultrafiltration Versus Diuretics

Summary: The purpose of this research study is to compare the effects (good and bad) of ultrafiltration treatment with standard intravenous (in your vein) diuretic therapy (furosemide, torsemide, bumetanide) on your heart function and blood flow.
Inclusion criteria: inclusion criteria:

 males and non-pregnant female patients over 18 years admitted to the hospital or treated in an outpatient heart failure clinic with the primary diagnosis of acute decompensated heart failure.

 evidence of fluid overload more than 8 kg above their dry weight, and conforming to definition of hypervolemia (at least two of the following findings: more than 1+ pitting edema of the lower extremities, jugular venous pressure more than 10 cm water, pulmonary edema or pleural effusion on chest radiograph consistent with ADHF, ascites, paroxysmal nocturnal dyspnea, or equal or more than 2 pillow orthopnea.

Exclusion criteria: :

 acute coronary syndrome

 documented ischemic cardiomyopathy

 atrial fibrillation

 serum creatinine more than 3.0 mg/dL

 systolic blood pressure less than 90 mmHg

 hematocrit > 45%

 clinical instability likely to require intravenous vasopressors and/or intravenous vasoactive drugs (such as milrinone, dobutamine, nitroglycerin or nesiritide) during the present hospitalization

 severe pulmonary hypertension or use of pulmonary hypertension drugs (such as sildenafil, bosentan or other endothelin inhibitors)

 patients with documented hypertrophic obstructive cardiomyopathy or restrictive cardiomyopathy,

 patients with severe valvular heart disease,

 patients with recent cocaine use (within one month of presentation)

 patients with heart transplant

 patients with systemic infection

 patients on hemodialysis

 inability to obtain venous access

 contraindications for anticoagulation

 unable to lie flat for at least 20 minutes

 pregnant and breast-feeding women.

['Loop diuretics (furosemide, torsemide, bumetanide)', 'Ultrafiltration']

Loop diuretics (furosemide
torsemide
bumetanide)
Ultrafiltration


Proton Pump Inhibitors and Gastrointestinal Symptoms

Summary: The aim of the study is to evaluate the potential protective effect of Lactobacillus paracasei subspecies paracasei F19 administration on bowel symptom onset in patients with gastro-esophageal reflux disease at long-term PPI treatment.
Inclusion criteria: inclusion criteria:

 recent onset of typical reflux symptoms (heartburn and regurgitation).

Exclusion criteria: :

 age <18 or >70 yrs

 pregnancy or breast-feeding

 evidence of major concomitant diseases (i.e., tumors, cardiovascular disorders and hepatic and/or renal failure)

 use of PPIs or H2-antagonists, non-steroidal anti-inflammatory drugs (NSAIDs) or antibiotics in the previous 3 months

 presence of Helicobacter pylori (H. pylori) infection

 erosive esophagitis

 presence of bowel symptoms such as bloating, flatulence, abdominal pain, diarrhea and constipation in the last 6 months or irritable bowel syndrome (IBS) according to Rome III criteria.

['Lactobacillus paracasei F19', 'Placebo']

['Gastrointestinal Symptoms', 'Small Intestinal Overgrowth']

Gastrointestinal Symptoms
Small Intestinal Overgrowth


Assessment of Ability of Breath Hold for Left-sided Breast Cancer Radiation Therapy to Reduce Side Effects to Heart

Summary: The purpose of this research study is to demonstrate that Deep Inspiration Breath Hold (DIBH), the technique used at the University of North Carolina (UNC) for left-side breast cancer radiation therapy, can reduce side effects to the heart.
Inclusion criteria: inclusion criteria:

 signed an Institutional Review Board (IRB)-approved informed consent document for protocol

 age >= 18 years

 histologically confirmed left-sided breast cancer scheduled to undergo curative intent radiation treatment post lumpectomy or mastectomy

 stage 0-III left-sided breast cancer (including DCIS)

 SPECT score of 0 at baseline

 radiation oncologist agrees target volume coverage will not be compromised via use of the DIBH technique along with conformal field shaping

Exclusion criteria: :

 active cardiac disease, defined as a history of angina, arrhythmias, myocardial infarction, congestive heart failure, or any other cardiac condition, which in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient

 symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators

 concurrent chemotherapy

 prior receipt of mediastinal radiation therapy

 pregnant or lactating women

 inability to understand and follow breathing instructions for the DIBH procedure


Natural History of Non-steroidal Anti-inflammatory Drug and Non-Helicobacter Pylori in Bleeding Peptic Ulcers

Summary: The aim of this study is to study the natural history of the ulcer healing while on proton pump inhibitors (PPI) and the ulcer recurrence without acid suppression therapy of Non-steroidal Anti-inflammatory Drugs (NSAID), non-Helicobacter pylori (HP) bleeding ulcer patients.
Inclusion criteria: inclusion criteria:

 Patient has non-NSAID (non-steroidal anti-inflammatory drugs), non-Helicobacter pylori bleeding peptic ulcer

 Age > 18 years old

 Informed consent

Exclusion criteria: :

 Concommitant use of high dose steroid or warfarin

 New start on non-steroidal anti-inflammatory drugs or aspirin or COX2 inhibitors

 Renal failure (serum creatinine > 200umol/l)

 Previous gastric surgery

 Oesophagitis, esophageal varices

 Terminal illness or malignancy


Scleroderma Treatment With Autologous Transplant (STAT) Study

Summary: This phase II trial studies how well giving cyclophosphamide and anti-thymocyte globulin together followed by peripheral blood stem cell transplant (PBSCT) and mycophenolate mofetil works in treating patients with systemic scleroderma (SSc). Stem cells are collected from the patient's blood and stored prior to treatment. To store the stem cells patients are given colony-stimulating factors, such as filgrastim (G-CSF) or chemotherapy (cyclophosphamide) to help stem cells move from the bone marrow to the blood so they can be collected and stored. After storage, patients are then given high-dose chemotherapy, cyclophosphamide, and immunosuppression with anti-thymocyte globulin to suppress the immune system to prepare for the transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and immunosuppression. After the stem cells have engrafted and have matured enough to support the immune system at approximately 2-3 months, patients are given a medication called mycophenolate mofetil (MMF) or Myfortic. This medication is given to prevent worsening or reactivation of SSc and is referred to as maintenance therapy.
Inclusion criteria: inclusion criteria:

 Patients with SSc as defined by the American College of Rheumatology with diffuse cutaneous disease (except Group 5) at risk of disease progression

 Patients must have failed a prior >= 4-mponth course of either MMF/Myfortic or cyclophosphamide before being eligible for the study (determined at >= 1 week before start of mobilization); failure is defined as evidence of disease progression or absence of improvement; the response prior to MMF of cyclophosphamide will be assessed by the participating site study rheumatologist

 Patients must meet eligibility in at least 1 of the following 6 groups:

 GROUP 1:

 Patients must have 1) both a and b below; and 2) either c, or d

 a) Diffuse cutaneous scleroderma as defined by skin thickening proximal to the elbows and knees and/or involving the torso in addition to distal extremity involvement; a skin score will be obtained but not used to determine eligibility

 b) Duration of systemic sclerosis =< 7 years from the onset of first non-Raynaud's symptom; for those patients with disease activity between 5-7 years from the onset of first non-Raynaud's symptom, recent progression or activity of disease must be documented

 c) Presence of SSc-related pulmonary disease with forced vital capacity (FVC) < 80% or hemoglobin-adjusted diffusing capacity for carbon monoxide (DLCO) < 70% of predicted AND evidence of alveolitis or SSc-related interstitial lung disease by high-resolution chest computed tomography (CT) scan and/or by bronchoalveolar lavage (BAL) (interstitial lung disease may be nonspecific interstitial pneumonia [NSIP] or usual interstitial pneumonia [UIP]; a bronchoalveolar lavage [BAL] should be done to confirm the findings of alveolitis only if the high resolution CT scan [HRCT] fails to show findings typically associated with systemic sclerosis changes [ground glass NSIP, UIP, SSc related interstitial lung disease]); alveolitis by BAL cell count will be defined based on a BAL cell differential count (> 3% neutrophils and/or > 2% eosinophils) from any lavaged lobe

 d) History of SSc-related renal disease that may not be active at the time of screening; stable serum creatinine must be documented for a minimum of 3 months post-renal crisis at the time of the baseline visit; history of scleroderma hypertensive renal crisis is included in this criterion and is defined as follows:

 History of new-onset hypertension based on any of the following (measurements must be repeated and confirmed at least 2 hours apart within 3 days of first event-associated observation, with a change from baseline):

 Systolic blood pressure (SBP) >= 140 mmHg

 Diastolic blood pressure (DBP) >= 90 mmHg

 Rise in SBP >= 30 mmHg compared to baseline

 Rise in DBP >= 20 mmHg compared to baseline

 AND one of the following 5 laboratory criteria:

 Increase of >= 50 % above baseline in serum creatinine

 Proteinuria: >= 2+ by dipstick confirmed by protein:creatinine ratio > 2.5

 Hematuria: >= 2+ by dipstick or > 10 red blood cell (RBC)s/hematopoietic-promoting factor (HPF) (without menstruation)

 Thrombocytopenia: < 100,000 platelets/mm^3

 Hemolysis: by blood smear or increased reticulocyte count

 The above definition of SSc hypertensive renal crisis is independent of whether concomitant anti-hypertensive medications are used

 Subjects who present with solely skin and renal disease in the absence of other organ involvement, except classic SSc renal crisis as described above and including non-hypertensive renal crisis, must see a nephrologist to confirm that their renal disease is secondary to only SSc

 Note: Subjects may be re-screened if they fail to meet inclusion criteria on initial evaluation

 GROUP 2:

 Progressive pulmonary disease as defined by a decrease in the FVC or DLCO-adjusted by 10 or 15 percent or greater, respectively, from a prior FVC or DLCO-adjusted in the previous 18-month period

 Patients will have diffuse cutaneous disease and may have both FVC and DLCOcorr >= 70% at screening for the study

 Patients must also have evidence of alveolitis as defined by abnormal chest computed tomography (CT) or bronchoalveolar lavage (BAL)

 GROUP 3: Diffuse scleroderma with disease duration =< 2 years since development of first sign of skin thickening plus modified Rodnan skin score >= 25 plus either

 Erythrocyte sedimentation rate (ESR) > 25 mm/1st hour and/or hemoglobin (Hb) < 11 g/dL, not explained by causes other than active scleroderma

 Lung involvement (either FVC or DLCO < 80% and evidence of interstitial lung disease by CT scan or alveolitis by BAL)

 GROUP 4: Diffuse scleroderma with disease duration =< 2 years and skin score >= 30

 GROUP 5:

 Limited cutaneous scleroderma and SSc-related pulmonary disease with FVC < 80% or hemoglobin-adjusted DLCO < 70% of predicted

 AND evidence of alveolitis/interstitial lung disease by high-resolution chest CT scan and/or by BAL (interstitial lung disease may be nonspecific interstitial pneumonia [NSIP] or usual interstitial pneumonia [UIP]; A bronchoalveolar lavage [BAL] should be done to confirm the findings of alveolitis only if the high resolution CT scan [HRCT] fails to show findings typically associated with systemic sclerosis changes [ground glass, NSIP, UIP, SSc related interstitial lung disease])

 Alveolitis by BAL cell count will be defined based on a BAL cell differential count (> 3% neutrophils and/or > 2% eosinophils) from any lavaged lobe

 GROUP 6: Progressive gastrointestinal disease as defined by all of the following items:

 Disease duration of scleroderma =< 2 years.

 Documented severe malabsorption syndrome requiring nutritional support; severe malabsorption syndrome is > 10% weight loss and on total parenteral nutrition (TPN) or enteral feedings

 High score on distention/ bloating scale (>= 1.60 out of 3.00) on gastrointestinal (GI) questionnaire

Exclusion criteria: :

 Subjects with pulmonary, cardiac, hepatic, or renal impairment that would limit their ability to receive cytoreductive therapy and compromise their survival; this includes, but is not restricted to, subjects with any of the following:

 Pulmonary dysfunction defined as:

 Severe pulmonary dysfunction with (1) a hemoglobin corrected DLCO < 40% of predicted at the Baseline Screening visit, or (3) FVC < 45% of predicted Baseline Screening visit, or

 Partial pressure (pO2) < 70 mmHg or pCO2 >= 45 mmHg without supplemental oxygen, or

 O2 saturation < 92% at rest without supplemental oxygen as measured by forehead pulse oximeter

 Significant pulmonary artery hypertension (PAH) defined as:

 Peak systolic pulmonary artery pressure > 50 mmHg by resting echocardiogram will require right heart catheterization; if pulmonary artery pressure (PAP) is not evaluable on echocardiogram due to lack of a Tricuspid regurgitant jet, then normal anatomy and function as evidenced by normal right atrium and ventricle size, shape and wall thickness and septum shape must be documented to rule-out PAH; otherwise, right heart catheterization is indicated; prior history of PAH but controlled with medications will not exclude patients from the protocol; PAH is considered controlled with medications if peak systolic pulmonary artery pressure is < 45 mmHg or mean pulmonary artery pressure by right heart catheterization is < 30 mmHg at rest

 Mean pulmonary artery pressure by right heart catheterization exceeding 30 mmHg at rest; if mean PAP is elevated and pulmonary vascular resistance and transpulmonary gradient are normal then the patient is eligible for the protocol

 New York Heart Association (NYHA)/World Health Organization Class III or IV

 Cardiac: Uncontrolled clinically significant arrhythmias; clinical evidence of significant congestive heart failure (CHF) (NYHA Class III or IV); left ventricular ejection fraction (LVEF) < 50% by echocardiogram

 History/presence of arrhythmia (even controlled) on chemical anti-arrhythmic(s) must have cardiac consult to ensure the subject could safely proceed with protocol requirements

 Significant renal pathology defined as:

 Estimated creatinine clearance (CrCl) < 40 mL/min (using Cockcroft-Gault formula based on actual body weight) and serum creatinine > 2.0 mg/dL; OR

 Active, untreated SSc renal crisis at the time of enrollment; presence of nephrotic range proteinuria (defined as >= 3.5 gms/24 hours, or protein:creatinine ratio >= 3.5), active urinary sediment, urinary RBCs > 25 per HPF, or red cell casts require further investigation by a nephrologist to rule out glomerulonephritis, overlap syndromes, or other causes of renal disease in all subjects; subjects with glomerulonephritis or overlap syndromes will be excluded

 Hepatic: Active hepatitis (alanine aminotransferase [ALT], aspartate aminotransferase [AST], or bilirubin > 2 times the upper limit of normal [ULN]) or evidence of moderate to severe periportal fibrosis by liver biopsy

 Active or clinically significant Gastric Antral Vascular Ectasia (GAVE, watermelon stomach)

 Unwilling or unable to discontinue disallowed disease-modifying antirheumatic drugs (DMARDs) for treatment of SSc prior to mobilization

 History or presence of a 2nd autoimmune disease requiring immunosuppressive therapy that has substantial risk of immunosuppressive treatment beyond transplant with the following exceptions:

 History and/or presence of Sjogren's Syndrome is allowed

 Stable myositis (A history of myositis that is clinically stable as defined by lack of progressive proximal muscle weakness and a stable or decreasing creatine phosphokinase [CPK] < 3 x ULN) is allowed

 The presence of anti-double stranded (ds)-deoxyribonucleic acid (DNA) without clinical systemic lupus erythematosus in a patient with a diagnosis of otherwise pure SSc is allowed

 Concomitant rheumatoid arthritis without extra-articular disease characteristic of rheumatoid arthritis is allowed

 Active uncontrolled infection that would be a contraindication to safe use of high-dose therapy

 Positive study for Hepatitis B surface antigen or Hepatitis B or C confirmed by polymerase chain reaction (PCR)

 Positive serology for human immunodeficiency virus (HIV)

 Absolute neutrophil count (ANC) < 1500 cells/uL

 Platelets < 100,000 cells/uL

 Hematocrit < 27%

 Hemoglobin < 9.0 g/dL

 Malignancy within the 2 years prior to entry in study, excluding adequately treated squamous cell skin cancer, basal cell carcinoma, and carcinoma in situ; treatment must have been completed (with the exception of hormonal therapy for breast cancer) with cure/remission status verified for at least 2 years prior to entry in this study

 Presence of other comorbid illnesses with an estimated median life expectancy < 5 years

 Evidence of myelodysplasia (MDS); subjects with history of receiving any prior chemotherapy and/or radiotherapy for the treatment of malignant disease, history of greater than 2 months total prior cyclophosphamide for any condition (regardless of dose and route) and/or subjects presenting with abnormal peripheral blood counts require unilateral bone marrow aspiration for pathology, flow cytometry, cytogenetics, and fluorescence in situ hybridization (FISH) MDS panel (per institutional profile) to rule out MDS

 Pregnancy

 Inability to give voluntary informed consent

 Unwilling to use contraceptive methods for at least 15 months after starting treatment

 History of smoking tobacco (or other related/herbal products) in the prior 3 months

 History of prior autologous hematopoietic cell transplantation

['Anti-Thymocyte Globulin', 'Autologous Hematopoietic Stem Cell Transplantation', 'Cyclophosphamide', 'Filgrastim', 'Laboratory Biomarker Analysis', 'Mycophenolate Mofetil', 'Peripheral Blood Stem Cell Transplantation', 'Plerixafor', 'Quality-of-Life Assessment', 'Questionnaire Administration']


PALACE 3: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis

Summary: The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis and a qualifying psoriasis lesion.~Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.
Inclusion criteria: inclusion criteria:

 Males or females, aged ≥ 18 years at time of consent.

 Have a diagnosis of Psoriatic Arthritis (PsA, by any criteria) of ≥ 6 months duration.

 Meet the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria for PsA at time of screening.

 Must have been inadequately treated by disease-modifying antirheumatic drugs (DMARDs)

 May not have axial involvement alone

 Concurrent Tx allowed with methotrexate, leflunomide, or sulfasalazine

 Have ≥ 3 swollen AND ≥ 3 tender joints.

 Males & Females must use contraception

 Stable dose of NSAIDs, narcotics and low dose oral corticosteroids allowed.

 Have at least one ≥2 cm psoriasis lesion

Exclusion criteria: :

 Pregnant or breast feeding.

 History of allergy to any component of the investigational product Hepatitis B surface antigen and/or Hepatitis C antibody positive at screening.

 Therapeutic failure on > 3 agents for PsA or > 1 biologic tumor necrosis factor (TNF) blocker

['Apremilast 20mg', 'Apremilast 30mg', 'Placebo']


Human Movement Database

Summary: This study will collect information on the different ways people control limb and body movements. This information will be used to develop a database on normal movements and adaptive movements of people who have diseases that affect the way they move. The database will serve as a tool to improve diagnosis and treatment of patients with movement-related problems.~Volunteers of all ages who have normal movement patterns or who have developed different ways to perform movement tasks may be eligible for this study. A physician or physical therapist will screen candidates to determine their strength, flexibility and range of motion of joints.~Participants will be asked to perform movements such as walking, walking up or down stairs, standing quietly or reaching for an object or using treadmill. For the test, the arms and legs are wrapped with a soft, rubber-like material to which small plastic reflective balls are attached. A piece of firm material called a shell may be attached to the rubber sleeves or other areas of the body. Then the volunteer performs the specified task several times while special cameras record the movement. These cameras will record the positions of the reflective balls during movement and may show the person s face or body. Electrical activity in the muscles also may be measured, using small metal electrodes attached to the surface of the skin with an adhesive bandage....
Inclusion criteria: Any volunteer of any age from birth to old age who is deemed medically fit to participate and is willing to provide their informed consent will be included in the study.
Exclusion criteria:


A Trial to Assess Optimal Postoperative Feeding Regiments Following Pyloromyotomy

Summary: There are several choices to consider when determining the timing of initiation of enteral feeds following a pyloromyotomy. Some practice patterns have initiated feedings as soon as the infant awakens from anesthesia. Some authors have suggested a period of withholding feedings for several hours postoperatively, while others have recommended a significantly longer period of starvation (18 hours) before initiating feedings. The ongoing debate arises over whether a physician chooses a standardized, incremental feeding regimen versus an ad libitum feeding schedule which allows the infant to decide when and how much to eat. Neither has been studied effectively in a randomized controlled setting. A recent review of the literature would suggest that a period of 4 hours of NPO, followed by ad lib feedings may be the best postoperative regimen. This however, has not been studied in a randomized, controlled trial.
Inclusion criteria: inclusion criteria:

 Subjects to be included in the study include infants who have a diagnosis of pyloric stenosis who will undergo pyloromyotomy.

Exclusion criteria: :

 Patients with severe underlying medical conditions including but not limited to hypothermia, sepsis, glycemic instability, or need for care in the intensive care unit/neonatal intensive care unit will not be included in the study.

['Postoperative Feeding Following Pyloromyotomy']


Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients With Chronic Constipation

Summary: The purpose of this study is to evaluate the effects of Functional Magnetic stimulation (FMS) on gastrointestinal motility in patients suffering from chronic constipation due to non-neurological issues.
Inclusion criteria: inclusion criteria:

 Age 18-80

 constipation defined by the Rome II criteria

Exclusion criteria: :

 Past history of abdominal surgery

 past history of diabetes mellitus

 past history of hypothyroidism

 past history of inflammatory bowel disease

 past history of significant psychiatric disturbances

 past history of drug abuse

 past history of cardiac pacemakers

 past history of metal implants

 patients who cannot travel to keep the follow up

 patients who are prisoners

 patients who are mentally handicapped

 patients who are pregnant


Epidemiological Study on Community Acquired Pneumonia

Summary: Long-term objectives of the basic research part are improvement of CAP-management with respect to therapy, diagnosis and prevention to contribute to a better care of patients with pneumonia.
Inclusion criteria: inclusion criteria:

 age ≥ 18

 infiltrate on chest X-ray

 further inclusion criteria: cough or production of purulent sputum or pathologic lung auscultation (crackles) or fever

Exclusion criteria: :

 hospital inpatient treatment within the last 28 days

 Immune suppressed patients


Evaluation of AN777 in Elderly Subjects

Summary: To evaluate whether AN777 with or without exercise affects muscle mass change in elderly subjects.
Inclusion criteria: inclusion criteria:

 Subject (male or female) is at least 65 years of age

 Subject has a Geriatric Nutritional Risk Index (GNRI)of 92 or over

 Subject has Body Mass Index (BMI) > 20.0 but <30.0

 Subject is ambulatory

 Subject agrees to maintain current activity level

Exclusion criteria: :

 Subject has undergone major surgery, less than 4 weeks prior to enrollment in the study

 Subject has current active malignant disease, except basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix

 Subject has stated immunodeficiency disorder

 Subject has stated history of diabetes

 Subject has stated presence of partial or full artificial limb

 Subject has stated kidney disease

 Subject has stated history of uncontrollable hypertension

 Subject had myocardial infarction within the last 3 months

 Subject had recent antibiotic use (within 1 week prior to screening).

 Subject has a history of allergy to any of the ingredients in the study products

 Subject has an obstruction of the gastrointestinal tract precluding ingestion of the study product, inflammatory bowel disease, short bowel syndrome or other major gastrointestinal disease

 Subject has stated uncontrolled severe diarrhea, nausea or vomiting

 Subject has untreated clinically significant ascites, pleural effusion or edema

 Subject has known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder or any other psychological condition that may interfere with study product consumption

 Subject is actively pursuing weight loss

 Subject is currently taking medications/dietary supplements/substances that could profoundly modulate metabolism or weight Exceptions for multi-vitamin/mineral supplement, inhaled steroids for asthma or chronic obstructive pulmonary disease, topical or optical steroids and short-term use (less than two weeks) of dexamethasone

['Ad lib diet and Control placebo', 'Ad lib diet and An 777', 'Ad lib diet/ placebo/ exercise', 'Ad lib diet; AN 777; exercise']

Ad lib diet and Control placebo
Ad lib diet and An 777
Ad lib diet/ placebo/ exercise
Ad lib diet; AN 777; exercise


Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25mcg Once Daily Compared With Tiotropium Bromide Inhalation Powder 18mcg Once Daily in Subjects With COPD Who Have or Are At Risk for Co-morbid Cardiovascular Disease

Summary: The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg once daily compared with tiotropium bromide inhalation powder 18mcg once daily over a 12-week treatment period in subjects with COPD who have or are at risk for co-morbid cardiovascular disease
Inclusion criteria: inclusion criteria:

 Signed and dated written informed consent

 Male or females ≥ 40 years of age

 Females must be post-menopausal or using a highly effective method for avoidance of pregnancy

 Established clinical history of COPD by ATS/ERS definition

 Post-albuterol spirometry criteria: FEV1/FVC ratio ≤ 0.70 and FEV1 ≥30 to ≤ 70% of predicted normal (NHANES III)

 Former or current smoker ≥10 pack years

 A history of diagnosed cardiovascular disease or a prior cardiovascular event including any of the following:

 Established (i.e., by clinical signs or imaging studies) coronary artery disease (CAD)

 Established (i.e., by clinical signs or imaging studies) peripheral vascular (i.e., arterial) disease (PVD)

 Previous stroke

 Objectively confirmed transient ischemic attack (TIA) (i.e., transient neurological deficit documented by a health-care professional)

 Previous myocardial infarction (MI) (Note: An MI within 6 months prior to Visit 1 is exclusionary)

 OR

 Presence of one of the following cardiovascular risk factors (in addition to being a former/current smoker):

 Current diagnosis of hypertension

 Current diagnosis of hypercholesterolemia

 Diabetes mellitus treated with pharmacotherapy

Exclusion criteria: :

 Current diagnosis of asthma

 Subjects with other respiratory disorders including α1-antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis (Note: focal bronchiectasis is not exclusionary), sarcoidosis, pulmonary fibrosis (Note: focal fibrotic pulmonary lesions are not exclusionary), pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases

 Lung volume reduction surgery within previous 12 months

 Clinically significant abnormalities not due to COPD by chest X-ray or CT scan

 Hospitalized for poorly controlled COPD within 12 weeks of Screening

 Poorly controlled COPD 6 weeks prior to Screening, defined as acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician

 Lower respiratory infection requiring antibiotics 6 weeks prior to Screening

 A moderate or severe COPD exacerbation and/or a lower respiratory tract infection (including pnuemonia) during the Run-In Period

 An abnormal, clinically significant finding in any liver chemistry, biochemical, or haematology tests at Screening (Visit 1) or upon repeat prior to randomization

 An abnormal, clinically significant ECG finding at Screening (Visit 1) or upon repeat prior to randomization

 An abnormal, clinically significant Holter finding at Screening (Visit 1) or upon repeat prior to randomization (sub-set of subjects)

 Historical or current evidence of clinically significant (in opinion of the Investigator) and unstable disease such as cardiovascular (e.g., patients requiring ICD, pacemaker requiring a ventricular pace rate set at >60 bpm, uncontrolled hypertension, New York Heart Association Class IV (New York Heart Association,1994), known left ventricular ejection fraction <30%), neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease), peptic ulcer disease, or haematological abnormalities

 Carcinoma not in complete remission for at least 5 years

 History of allergy or hypersensitivity to any of the study medications (e.g., anticholinergic/muscarinic receptor antagonist, beta2-agonist, corticosteroid) or components of the inhalation powder (e.g., lactose, magnesium stearate) or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholinergic. In addition, subjects with a history of severe milk protein allergy that, in the opinion of the Investigator, contraindicates the subject's participation will also be excluded

 Known/suspected history of alcohol or drug abuse in the last 2 years

 Women who are pregnant or lactating or plan to become pregnant

 Subjects medically unable to withhold albuterol /salbutamol for 4 hours prior to spirometry testing at each study visit

 Use of certain medications such as bronchodilators and corticosteroids for the protocol-specific times prior to Visit 1 (the Investigator will discuss the specific medications)

 Long Term Oxygen Therapy (LTOT) or nocturnal oxygen therapy >12 hours a day

 Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening or during the study

 Failure to demonstrate adequate compliance defined as completion of the Diary Card (completed all diary entries on at least 4 of the last 7 consecutive days), the ability to withhold COPD medications and to keep clinic visit appointments

 Non-compliance or inability to comply with study procedures or scheduled visits

 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

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

['fluticasone furoate/vilanterol 100/25mcg', 'tiotropium bromide 18mcg']

['Pulmonary Disease, Chronic Obstructive']


Vaccine Study for Tick-Borne Encephalitis Virus (TBEV)

Summary: This was an open label trial of a non-US licensed vaccine for tick-borne encephalitis. The vaccine was licensed by Baxter, and now following an acquisition by Pfizer Inc in Vienna, Austria since 2001, and has an extensive safety record in multiple European countries. Field effectiveness studies suggest > 99 percent protection against disease transmitted by the natural routes of either tick bite or ingestion of contaminated, unpasteurized milk. The vaccine is also considered to be effective against laboratory exposures and is used routinely for this purpose in European laboratories. The US Centers for Disease Control and Prevention and the National Institutes of Health acknowledge the effectiveness of the vaccine by allowing those who have received it to study tick-borne encephalitis virus (TBEV) in isolation facilities rated at BSL-3 rather than the more stringent BSL-4, with the exception of the Russian Spring-Summer Encephalitis strain. Subjects were recruited from personnel at 2 intramural campuses of the National Institute of Allergy and Infectious Diseases who may be exposed accidentally to any strain or serotype of viable TBEV. Approximately 160 individuals were eligible to participate. The rapid immunization schedule (injections on Days 0, 14, and 161) was used and subjects had labs drawn 21 days after the 2nd, 3rd and 4th vaccine injections to determine seroconversion. Subjects that seroconverted to TBEV were offered a booster dose of the vaccine 3 years from the date of receipt of the third dose of the vaccine. Subjects that were seropositive at entry into the study were offered a booster dose of the vaccine every 3 years from Day 0.
Inclusion criteria: inclusion criteria:

 All subjects must meet the following criteria at study entry:

 Be engaged in activities that place them at potential risk of occupational exposure to TBEV in its viable form at one of the participating intramural laboratories of NIAID

 Be 18 years of age or older at the time of the first immunization.

 Comprehend the study requirements.

 Provide written informed consent to participate in this study.

 Be in good health as determined by the Investigator, based upon medical history and a targeted physical examination.

 Have a stable health status as determined by the Investigator.

 Have access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device (i.e., a common use phone serving multiple rooms or apartments).

 Express availability for the required study period, and ability to attend scheduled visits.

Exclusion criteria: :

 The following criteria should be checked at the time of the study entry. If any apply, the subject will not be included in the study:

 The subject must not be participating in any other trial of an investigational drug or vaccine for 1 month prior to the first injection through until 21 days after the third injection. (Given the nature of the work these study subjects engage in, exemptions to this proscription may be granted on a case by case basis after discussion between the Investigator and the IRB.)

 The presence on the day of immunization of an oral temperature of >101.2 degrees F or acute symptoms other than mild severity.

 Active systemic infectious process as determined by review of systems and physical examination. The subject may be enrolled at a later date once the illness has resolved.

 Known immune suppression, such as that associated with human immunodeficiency virus infection, or other condition, to the extent that, in the opinion of the Investigator, the subject is likely to have a poor response to the vaccine. This information will be obtained by history only. Serologic screening for these diseases will not be performed.

 Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the Investigator to render the potential subject unable/unlikely to report promptly any adverse reactions to the vaccine.

 Current diagnosis of leukemia, Hodgkin s disease, non-Hodgkin s lymphoma, or any other cancer, autoimmune disease such as lupus, which is in and of itself a cause of immunosuppression to the point that, in the opinion of the Investigator, the subject is likely to have a poor response to the vaccine.

 Currently receiving systemic immunosuppressive chemotherapy or immunotherapy (including glucocorticoids) resulting in immune suppression to the point that, in the opinion of the Investigator, the subject is likely to have a poor response to the vaccine.

 Any neurological condition in which (in the opinion of the Investigator) the integrity of the blood brain barrier may have been compromised.

 Licensed vaccines are not exclusionary but should be given at least 14 days before or after immunization (applies to each of the 3 scheduled TBEV injections) for inactivated vaccines and 30 days before or after immunization with any live vaccines. This is in order to avoid potential confusion of adverse reactions. (Given the nature of the work these study subjects engage in, exemptions to this proscription may be granted on a case-by-case basis after discussion between the Investigator and the IRB.).

 Previous anaphylactic reaction to any TBE vaccine.

 Known or suspected anaphylactic reaction to any constituent of FSME IMMUN, to include formaldehyde, protamine sulfate, gentamicin and neomycin, or current egg allergy.

 Known pregnancy, or anticipating becoming pregnant in the first 8 months of the study or a positive urine beta-human chorionic gonadotropin (beta hCG) test result prior to immunization. If subjects become pregnant at some point in time after the 1st injection, no further injections will be given until after the pregnancy is completed, they are no longer nursing or have a negative beta-hCG result.

 Lactating or nursing.

 Women of child bearing potential (defined as pre-menopausal who have not undergone either hysterectomy or tubal ligation) who lack a history of reliable contraceptive practices. Reliable contraceptive practices (for the first 8 months of the study and within 21 days prior to or 42 days after booster immunizations) include:

 Consistent abstinence from heterosexual activity

 Consistent use of combined or progestogen oral contraceptives

 Injectable progestogen

 Implants of levonorgestrel

 Estrogen or estrogen/progestogen vaginal ring

 Percutaneous contraceptive patches

 Intrauterine device (IUD) or intrauterine system (IUS)

 Successful vasectomy of the sole male partner, or

 Double barrier method (condom or occlusive cap plus spermicidal agent)

 A history of a prior infection with TBEV or previously receiving a TBE vaccine will not be considered as an exclusionary criterion for immunization through this protocol. However, these subjects antibody titer data will not be included in the statistical analysis.

 Any other conditions, which in the Investigator s judgment, might result in an increased risk to the subject, or would affect their participation in the study. Additionally the Investigator has the ability to exclude a subject if for any reason he/she feels the subject is not a good candidate for the study or will not be able to follow study procedures.

['Tick-Borne Encephalitis', 'Encephalitis, Tick-Borne', 'Tick-Borne Disease', 'Glycoprotein E, Flavivirus', 'NSI Protein, Flavivirus']

Tick-Borne Encephalitis
Encephalitis
Tick-Borne
Tick-Borne Disease
Glycoprotein E
Flavivirus
NSI Protein
Flavivirus


The HERO-study: Effects of Roflumilast in Patients With COPD (Chronic Obstructive Pulmonary Disease) (BY217/M2-121)

Summary: The purpose of this trial is to study the effects of roflumilast on lung function parameters indicative of hyperinflation in patients with COPD.
Inclusion criteria: Main inclusion criteria:

 Written informed consent

 Patients with a history of chronic obstructive pulmonary disease for at least 12 months as defined by the GOLD (Global Initiative on Obstructive Lung Diseases) criteria (2003)

 Age ≥ 40 years

 FEV1/FVC ratio (post-bronchodilator) ≤ 70%

 FEV1 (post-bronchodilator) ≤ 65% of predicted

 FRC (post-bronchodilator) ≤ 120% of predicted

 Clinically stable COPD within 4 weeks prior to baseline visit (B0).

 Availability of a chest x-ray dated a maximum of 6 months prior to study baseline visit (B0) or a willingness to have a chest x-ray performed at visit (B0).

 Main
Exclusion criteria: :

 COPD exacerbation indicated by a treatment with systemic glucocorticosteroids not stopped at least 4 weeks prior to the baseline visit (B0)

 Non smoker, current smoker or ex-smoker (smoking cessation at least one year ago) with a smoking history of < 10 pack years

 Suffering from any concomitant disease that might interfere with study procedures or evaluation

 Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit (B0)

 Diagnosis of asthma and/or other relevant lung disease (e.g. history of bronchiectasis, cystic fibrosis, bronchiolitis, lung resection, lung cancer, interstitial lung disease [e.g. fibrosis, silicosis, sarcoidosis], and active tuberculosis)

 Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 2 months preceding the baseline visit (B0).

 Known alpha-1-antitrypsin deficiency

 Need for long term oxygen therapy defined as ≥ 15 hours/day

 Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator)

 Known infection with HIV, active hepatitis and/or liver insufficiency

 Diagnosis or history of cancer (other than basal cell carcinoma) or recurrence within 5 years prior to study start

 Clinically significant cardiopulmonary abnormalities (diagnosed clinically or by x-ray/ECG) that are not related to COPD and that require further evaluation

 Pregnancy, breast feeding, oocyte donation or oocyte implantation planned during the trial

 The female patient is of childbearing potential and is not using and is not willing to continue to use a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless she is surgically sterilized/hysterectomized or post-menopausal > 1 year or any other criteria considered sufficiently reliable by the investigator in individual cases

 Participation in another study (use of investigational product) within 30 days preceding the baseline visit (B0) or re-entry of patients already enrolled in this trial

 Suspected inability or unwillingness to comply with study procedures

 Alcohol or drug abuse

 Inability to follow study procedures due to, for example, language problems or psychological disorders

 Use of prohibited drugs

 Suspected hypersensitivity to the study medication and/or contraindication to any ingredients of the study medication (roflumilast) or rescue medication

['Chronic Obstructive Pulmonary Disease, COPD']

Chronic Obstructive Pulmonary Disease
COPD


Lupus Cohort--Thrombotic Events and Coronary Artery Disease

Summary: To study longitudinally the incidence, pathogenesis, and risk factors for thrombotic events and coronary artery disease in a cohort of patients with systemic lupus erythematosus (SLE).
Inclusion criteria: No eligibility criteria
Exclusion criteria:

['Cardiovascular Diseases', 'Coronary Disease', 'Thrombosis', 'Heart Diseases', 'Lupus Erythematosus, Systemic']

Cardiovascular Diseases
Coronary Disease
Thrombosis
Heart Diseases
Lupus Erythematosus
Systemic


Beta-Blocker Continuation Versus Interruption in Heart Failure Worsening

Summary: The objective of the B-Convinced study is to demonstrate the non-inferiority of beta-blocker continuation compared to its interruption in patients with congestive heart failure who are treated by a beta-blocker and present with an episode of heart failure worsening with pulmonary oedema requiring hospital admission.~162 patients will be randomized in cardiology centers in France. Clinical status (primary endpoint) will be evaluated with a standardized questionnaire 3 days after hospital admission.
Inclusion criteria: inclusion criteria:

 Patients with heart failure treated with beta-blocker; hospitalisation for heart failure worsening with pulmonary oedema.

 Left ventricular ejection fraction less than 40%

Exclusion criteria: :

 Indication of intravenous positive inotropic treatment

 Indication to withdraw beta-blocker treatment


Study of Methyl Aminolaevulinate Photodynamic Therapy With and Without Er:YAG Laser in Bowen's Disease

Summary: Methyl aminolaevulinate photodynamic therapy (MAL-PDT) is an effective treatment for Bowen's disease (BD) of the lower extremities. Er:YAG ablative fractional laser (AFL) treatment removes the stratum corneum to increase MAL uptake and may improve efficacy. However, no studies have directly compared the efficacy of MAL-PDT with and without Er:YAG AFL in treating BD of the lower extremities in Asians.
Inclusion criteria: inclusion criteria:

 Korean patients aged ≥ 18 years who had biopsy-confirmed BD lesions on the lower extremities

Exclusion criteria: :

 porphyria,

 known allergies to the MAL cream or lidocaine,

 pregnancy,

 lactation,

 any active systemic infectious disease,

 immunosuppressive treatment,

 personal history of malignant melanoma,

 tendency towards melasma or keloid formation,

 prior treatment of the lesions within 4 weeks, and

 any indication of poor compliance