Safety of and Immune Response to a Dengue Virus Vaccine (rDEN1delta30) in Healthy Adults

Summary: Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and subtropical regions of the world. The purpose of this study is to test the safety of and immune response to a new dengue virus vaccine in healthy adults.
Inclusion criteria: inclusion criteria:

 Willing to be followed for the duration of the study

 Willing to use acceptable methods of contraception

 Good general health

Exclusion criteria: :

 Clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease

 Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study

 Liver, renal, or hematologic disease

 Alcohol or drug abuse within 12 months of study entry

 History of severe allergic reaction or anaphylaxis

 Emergency room visit or hospitalization for severe asthma within 6 months of study entry

 HIV-1 infected

 HCV infected

 Hepatitis B surface antigen positive

 Known immunodeficiency syndrome

 Use of corticosteroids or immunosuppressive drugs within 30 days of study entry. Participants who have used topical or nasal corticosteroids are not excluded.

 Live vaccine within 4 weeks of study entry

 Killed vaccine within 2 weeks of study entry

 Blood products within 6 months of study entry

 Investigational drugs or vaccines within 60 days prior to study entry or while currently enrolled in this clinical trial

 Previously received a licensed or experimental yellow fever or dengue vaccine

 Surgical removal of spleen

 History of dengue virus infection or other flavivirus infection

 Other condition that, in the opinion of the investigator, would affect the participant's participation in the study

 Pregnancy or breastfeeding

 Plan to travel to an area where dengue infection is common


Paracetamol as Antipyretic and Analgesic Medication

Summary: The present study is aiming to unravel the clinical efficacy of intravenously administered paracetamol as antipyretic and analgesic medication in various medical conditions.
Inclusion criteria: inclusion criteria:

 Age greater than or equal to 18 years

 Written informed consent by the patients

 Medical condition necessitating the administration of antipyretic or analgesic medications

Exclusion criteria: :

 Αge lower than 18 years

 Lack of informed consent

 History of liver cirrhosis

 Blood creatinine greater than 3mg/dl

 Blood AST greater than 3 times the upper normal level according to the lab of the participating hospital

 History of hypersensitivity to non-steroidal ant-inflammatory drugs

 History of abuse of analgesics

 Pregnancy or lactation

 Fulminant hemorrhage of the upper or lower digestive tract

 Thrombocytopenia defined as less than 50000 platelets/μl


Optic Nerve Sheath Diameter for Prediction of Outcome After Cardiac Arrest

Summary: Early prognostication in resuscitated cardiac arrest (CA) patients, within the first day after admission in the intensive care unit (ICU), remains difficult. Optic nerve sheath diameter (ONSD) measurement could predict increased intracranial pressure. Preliminary works showed that ONSD measurement could be used to predict outcome in post-CA patients.~The aim of this study was to assess the ability of bedside ONSD ultrasonographic measurement to predict survival and Cerebral Performance Category (CPC) score at hospital discharge in post-cardiac arrest patients treated with therapeutic hypothermia (TH).
Inclusion criteria: inclusion criteria:

 Unconscious (Glasgow Coma Scale ≤6)

 ≥18 years old

 Admitted in ICU after successful resuscitation from CA

 Treated with TH targeted to 33°C

Exclusion criteria: :

 unavailable ONSD measurement within 24 hours after return of spontaneous circulation (unavailable investigator, early death, or major hemodynamic instability)

 Traumatic or neurological origin of CA

 Previous cerebrovascular disease

 Facial trauma affecting the orbits and/or eyeballs

 Previous history of ocular pathology such as exophthalmia, glaucoma or cataract.


Phase I Study of GSK1550188 in Japanese Subjects With Systemic Lupus Erythematosus (SLE)

Summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK1550188 in Japanese subjects with Systemic Lupus Erythematosus (SLE).
Inclusion criteria: inclusion criteria:

 Subjects who gave consent to this study participation and signed into informed consent form.

 Subjects who are at least 20 years of age at Screening visit.

 Have a clinical diagnosis of Systemic Lupus Erythematosus (SLE) according to the American College of Rheumatology (ACR) classification criteria, with 4 or more of the 11 ACR criteria present, serially or simultaneously during any interval or observation.

 Be on either no SLE medication or a stable SLE treatment regimen of any medication (e.g., low-dose prednisone, NSAIDs; alone or in combination) for a period of at least 2 months prior to the Screening visit.

 Males and females. A female subject is eligible to enter the study if at least one of the following conditions apply:

 Not pregnant or nursing;

 Of non-childbearing potential (ie, women who had a hysterectomy, are postmenopausal which is defined as 1 year without menses, have both ovaries surgically removed or have current documented tubal ligation); or

 Of childbearing potential (ie, women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea [even severe], women who are perimenopausal or have just begun to menstruate. These women must have a negative serum pregnancy test at screening, and agree to 1 of the following:

 Complete abstinence from penile-vaginal intercourse, when this is the female's preferred and usual lifestyle, from 2 weeks prior to administration of the 1st dose of investigational product until 8 weeks after the last dose of investigational product; or

 Consistent and correct use of 1 of the following acceptable methods of birth control for 1 month prior to the start of the investigational product and for 8 weeks after the last dose of investigational product:

 Implants of etonogestrel or levonorgestrel;

 Estrogenic vaginal ring

 Injectable progesterone

 Any intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year

 Oral contraceptives (either combined or progesterone only)

 Double barrier method with vaginal spermicidal agent: Condom and an occlusive cap (cervical cap/vault or diaphragm) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)

 Percutaneous contraceptive patch

 The subject is positive test for anti-nuclear antibody (ANA) or anti-dsDNA antibody in serum

Exclusion criteria: :

 Active lupus nephritis requiring hemodialysis, intravenous cyclophosphamide (Cytoxan),or high-dose prednisone (>60 mg/day) within 6 months prior to the Screening visit

 The subject has severe lupus kidney disease (defined by proteinuria > 6 g/day) within 6 months prior to the Screening visit.

 Received IVIG or plasmapheresis within 6 months prior to Screening visit

 Active CNS lupus [including seizures, psychosis, organic brain syndrome, cerebrovascular accident (CVA), motor neuropathy, vasculitis] requiring medical intervention within 6 months prior to Screening visit

 The subject has hypogammaglobulinemia or IgA deficiency (IgA level < 10 mg/dL)

 History of renal transplant

 History or clinical evidence of active significant acute or chronic diseases (i.e., cardiovascular, pulmonary, untreated hypertension, anemia, gastrointestinal, hepatic, renal, neurological, cancer, or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk

 History of any other medical disease, laboratory abnormalities, or conditions which would make the subject (in the opinion of the Investigator) unsuitable for the study

 History of any infection requiring hospitalization or parenteral antibiotics within 4 weeks prior to Screening visit

 The subject has an abnormality on 12-lead ECG at screening which is clinically significant in the opinion of the investigator.

 The subject is currently participating in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational agent.

 The subject has received a biologic investigational and non-investigational agent within 12 months prior to the dosing day.

 The subject has received a non-biologic investigational agent within 2 months prior to the dosing day.

 Have evidence of current drug or alcohol abuse or dependence.

 Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2x upper limit of normal (ULN); alkaline phosphatase and bilirubin >1.5xULN (isolated bilirubin >1.5ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

 Have a historically positive HIV test or test positive at screening for HIV.

 History of, or positive test at Screening visit for any of HBsAg, anti-HBcAb or anti-HCVAb. If only anti-HBcAb result is positive, HBV-DNA test will be performed. If HBV-DNA results in negative, the patient is eligible.


The Association of Costimulatory Molecules and PPAR-polymorphisms With Autoimmune Thyroid Disease in Taiwan

Summary: Autoimmune thyroid disease is the most common organ-specific autoimmune disease. AITD include Graves' disease and Hashimoto's thyroiditis. Although the pathogenesis of AITD remains unclear, it is generally thought that the mechanisms of the disease is a complex disease in which susceptibility genes and environmental triggers act in concert to initiate the autoimmune response to the thyroid.~The initial step of thyroid autoimmunity is the activation of T cells. The activation of T cell requires two signals: firstly, thyroid follicular cells or antigen presenting cells binds to T cell receptor through antigenic HLA complex. Secondly, the activation of T cells is also required the interaction of costimulatory molecules between thyroid follicular cells and immune cells, including CTLA-4, CD 40, CD28, ICOS. PPAR- is a kind of intranuclear transcription factor, associated with adipogenesis and inflammation. Some reports showed that PPAR- polymorphism may have a protective effect from Graves' ophthalmopathy.~The goal of the study is to investigate the relationship among SNP and mRNA of costimulatory molecules and PPAR- , serum cytokine including TNF- and sIL-2R, and clinical characteristics in AITD patients. From the study, we hope to clarify the role of costimulatory molecules and PPAR- polymorphism in AITD.
Inclusion criteria: inclusion criteria:

 Autoimmune thyroid patients

 patients who cut Nodular Goiter in Wanfang Hospital

Exclusion criteria: :

 none

['AITd Patients With Different Polymorphisms']


Echo Detection of Endoscopic Retrograde Cholangiopancreatography (ERCP) Air Embolus

Summary: Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopy technique to visualize and evaluate the pancreatic and biliary systems. It has been reported that rare instances of air embolus have been found associated with the performance of an ERCP and many of these events are fatal. It is our proposal to use transthoracic echocardiography to continuously evaluate for the presence of intra-cardiac air secondary to ERCP venous air embolism and attempt to quantify the incidence of this complication and any potential patient factors that might increase the risk of this complication.
Inclusion criteria: inclusion criteria:

 Subject is undergoing ERCP as part of their medical care

 Subject will be of age 19 or older

Exclusion criteria: :

 Subject positioning for the ERCP is prone, thereby inhibiting the performance of the TTE

 Subject intolerance of the pressure of the TTE probe

 Subject body habitus interferes with obtaining adequate images to assess for intra-cardiac air

['Air Embolism as A Complication of Medical Care']


STOPBANG As A Screening Tool for Obstructive Sleep Apnoea in Pregnancy

Summary: This study evaluates the use of the STOPBANG questionnaire to predict whether a pregnant woman with class III obesity has obstructive sleep apnoea. All participants will have a STOPBANG score and modified STOPBANG score (substituting Epworth score > 10 with the tired item) calculated and then be tested with overnight pulse oximetry to see if they meet ODI criteria for obstructive sleep apnoea.
Inclusion criteria: inclusion criteria:

 Pregnant women

 Body mass index ≥ 40 at first midwife appointment

 Women ≥ 18 years of age

Exclusion criteria: :

 Pre-existing obstructive sleep apnoea on treatment

 Pre-existing restrictive or obstructive respiratory disease

 Women with another cause of sleep apnoea (e.g. central sleep apnoea)

 Women under 18 years of age

 Women who do not provide or refuse consent

 Women lacking capacity to consent

['STOPBANG Questionnaire', 'Overnight pulse oximetry', 'Epworth Sleepiness Scale']

STOPBANG Questionnaire
Overnight pulse oximetry
Epworth Sleepiness Scale

['Obstructive Sleep Apnoea', 'Pregnancy']


Role of T-cells in Post-Menopausal Osteoporosis

Summary: This is an observational study of women undergoing surgical menopause to determine whether T-cells play an important role in the etiology of post-menopausal osteoporosis. Subjects will examined before and after surgery and followed over a two year period to determine the biology of T-cells during this study period.
Inclusion criteria: inclusion criteria:

 Women between the age of 18-55, pre-menopausal by history (regular spontaneous menstrual bleeding every 21-35 days) or documented FSH <10, no current estrogen therapy, undergoing hysterectomy with (ovx) or without ovariectomy (control group) for benign gynecologic disease (fibroid uterus, endometriosis, dysfunctional uterine bleeding, chronic pelvic pain) or for prophylaxis against ovarian cancer (BRCA positive).

Exclusion criteria: :

 History of an active cancer including breast and uterine cancer, treatment with chemotherapy or glucocorticoids

 History of an immune deficiency syndrome including HIV infection

 History of severe anemia with hematocrit < 25.


Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury

Summary: Induction of hypothermia to < 35˚C by < 2.5 hours after severe traumatic brain injury, reaching 33˚C by 4 hours after injury and maintained for 48 hours in patients aged 16-45 will result in an increased number of patients with good outcomes at six months after injury compared to patients randomized to normothermia.
Inclusion criteria: inclusion criteria:

 Non-penetrating brain injury with post-resuscitation Glasgow Coma Score (GCS) < 8 (motor 1-5)

 Estimated or known age > 16 and < 45 years old

 Time of Injury within 2.5hrs of arrival at hospital

Exclusion criteria: :

 GCS = 7 or 8 with a normal head Cat Scan (CT) scan or showing only mild Subarachnoid hemorrhage (SAH)or skull fracture or GCS > 9 post- randomization

 GCS = 3 AND bilaterally non-reactive pupils

 Abbreviated Injury Score (AIS) > 4 for any body area except head

 Positive abdominal ultrasound or CT scan

 Persistent hypotension (systolic blood pressure < 110mmHGg)

 Persistent hypoxia (O2 Saturation < 94%)

 Positive pregnancy test

 Injured greater than 2.5 hours from hospital arrival

 Pre-existing medical conditions, if known


Follow-up Studies of Primary Snoring(PS) and Obstructive Sleep Apnea Hypopnea Syndrome(OSAHS) in Chinese Children

Summary: The study is designed to investigate the natural course of Primary snoring in 1-2 years or more and the different effect of drug and surgical treatment applied in children with obstructive sleep apnea (OSAS) by comparing the polysomnography(PSG) and sleep questionaires in 6 months after treatment.
Inclusion criteria: inclusion criteria:

 Children aged 3-12 yrs, who are referred for clinical evaluation of habitual snoring and who were scheduled for an overnight polysomnogram.

Exclusion criteria: :

 Children who are suffered from any chronic medical or psychiatric condition

 Children with acute respiratory infection

 Children with severe craniofacial deformities

 Children with cardiopulmonary diseases

 Children with a genetic syndrome that was known to affect cognitive abilities, or are receiving medications that are known to interfere with memory or sleep onset or heat rate

['Adenotonsillectomy', 'Conservative treatment', 'no treatment']

Adenotonsillectomy
Conservative treatment
no treatment


A Phase II Trial of Valproic Acid in Patients With Advanced Thyroid Cancers of Follicular Cell Origin

Summary: Background:~Patients who have advanced thyroid cancer have a low long-term survival rate. These types of thyroid cancer do not respond well to conventional surgery or radiation, or to specific thyroid cancer treatments such as radioactive iodine treatment and thyroid hormone for thyroid stimulating hormone (TSH) suppression.~Valproic acid has long been approved as an anticonvulsant to treat seizures in patients with epilepsy. It has also been used to treat bipolar disorder. Recent studies have shown that valproic acid has promising effects in thyroid cancer treatment because it may help destroy cancer cells and help conventional treatments be more effective. However, valproic acid is not approved for thyroid cancer and is therefore an investigational drug.~Objectives:~To determine whether valproic acid can inhibit tumor growth or induce tumor cell death.~To determine whether valproic acid can make tumor cells increase their uptake of radioiodine.~Eligibility:~- Individuals at least 18 years of age who have advanced-stage thyroid cancer that is either unresponsive to conventional treatments or fails to absorb radioiodine.~Design:~Eligible participants will continue on the standard thyroid hormone suppression therapy and begin receiving valproic acid for a total of 10 weeks. Participants will keep a study diary to record doses and side effects, and will have regular clinic visits to provide blood samples and receive additional valproic acid.~After 10 weeks, participants will have a Thyrogen scan to measure radioiodine uptake after valproic acid therapy. Tumor biopsies and blood samples will be taken at this time.~If there is increased radioiodine uptake on the scan, participants will have additional radioiodine therapy.~If there is no increased uptake on the scan, participants will continue on valproic acid for 7 more weeks. After 16 total weeks of treatment, additional blood samples and scans will be taken. Participants may continue to take valproic acid if the thyroid cancer appears to be responding to the treatment.~Follow-up visits will be scheduled at 3, 6, 9 (for patients continuing on valproic acid only), and 12 months.
Inclusion criteria: inclusion criteria:

 Advanced/poorly differentiated thyroid cancers of follicular cell origin that have no uptake (less than 1%) on radioiodine scan or are unresponsive to radioiodine therapy. Unresponsiveness to radioiodine therapy is defined as a patient s thyroglobulin not falling to less than 2ng/ml within 6 months after previous radioiodine ablative treatment.

 Extensive (invasive) loco-regional tumor mass and/or metastatic spread, rendering patient inoperable.

 Thyroglobulin (Tg) levels greater than or equal to 100 ng/ml in the absence of Tg antibodies. Patients who are Tg-antibody (Tg-Ab) positive may be included despite a lower Tg level if they have detectable disease on cross sectional imaging. (The presence of Tg-Ab may lead to falsely low Tg levels and therefore render the Tg a less sensitive marker of disease. However, Tg-Ab has been shown to also act as a tumor marker, and will be used as an endpoint for the study in patients who are Tg-Ab positive.).

 Within 18 months of enrollment, patients must have had an radioactive iodine (RAI) scan, showing no or therapeutically insignificant RAI uptake (less than or equal to 1%).

 Initial therapy must have included total/near-total thyroidectomy and RAI ablation therapy.

 Patients must have had no chemotherapy, radiotherapy, or biologic therapy for their malignancy in the month prior to treatment and must have recovered from all side effects of therapeutic and diagnostic interventions.

 Greater than or equal to 18 years of age.

 Must be able to understand and sign the Informed Consent Document.

 Clinical performance status of Eastern Oncology Cooperative Group (ECOG) less than or equal to 1.

 Life expectancy of greater than three months.

 Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (HCG) within 72 hours prior to study entry and must be willing to practice effective birth control to prevent pregnancy while receiving treatment and for three months after treatment is discontinued. All males of child fathering potential must also be willing to practice effective birth control.

 Laboratory results must be within the following parameters before entry:

 Absolute Neutrophil Count greater than 750 cells/mm(3)

 Hemoglobin greater than 8.0 gm/dl

 Platelet count greater than 75000/mm(3)

 Creatinine less tha 1.5 times upper limit of normal (ULN)

 Total protein greater than 6.4.

 Total bilirubin should be less than 1.5 times ULN.

 Aspartate aminotransferase (AST) serum glutamic oxaloacetic (SGOT), alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) less than 1.5 times ULN.

 Amylase less than 1.5 times ULN

 Ammonia less than 1.5 times ULN

Exclusion criteria: :

 Allergy to valproic acid.

 Current coexisting malignancy other than basal cell carcinoma.

 Women of child-bearing potential who are pregnant or breastfeeding.

 Valproic acid is a known teratogen, causing primary neural tube defects, facial abnormalities, and skeletal malformation; therefore pregnant women will be excluded. Additionally, patients that become pregnant while on study protocol will be discontinued immediately.

 Active systemic infections, coagulation disorders or other major medical illnesses.

 Patients taking tolbutamide, warfarin, zidovudine, benzodiazepines, clonazepam, diazepam.

 Seizure disorder.

['Valproic Acid', 'Liothyronine Sodium']


Bi Treatment With Hydralazine/Nitrates Versus Placebo in Africans Admitted With Acute Heart Failure

Summary: To investigate the effect of hydralazine isosorbide dinitrate on clinical outcomes, symptoms, cardiac parameters and functional status of African patients hospitalized with AHF and left ventricular dysfunction during 24 weeks of therapy.~Administration of hydralazine/nitrates will be superior to placebo administration in reducing HF readmission or death, improving dyspnoea, reducing blood pressure and brain natriuretic peptide (BNP) in African patients admitted with AHF and left ventricular dysfunction.
Inclusion criteria: inclusion criteria:

 > 18 years of age

 Hospital admission for acute heart failure as defined by the presence of acute dyspnea and the presence of clinical signs of heart failure on physical examination.

 Where available, NT-proBNP >900 pg/ml, >1800 pg/ml if the patient has atrial fibrillation at screening or >450 pg/ml if BMI > 35 kg/m2, LVEF <45% assessed by echocardiography or other method within the previous 12 months

 Background therapy with at least ACE-inhibitor or angiotensin receptor blocker (ARB) and beta-blocker (unless beta-blocker is contraindicated due to severe volume overload, low output heart failure, or cardiogenic shock)

 Available for regular follow up

Exclusion criteria: :

 Currently being treated with Hydralazine and/or nitrates or a history of intolerance to oral therapy with either hydralazine or nitrates.

 . Any intravenous treatment for heart failure, except IV furosemide (eg. IV inotropes, pressors, nitrates or nesiritide) at the time of screening.

 Systolic blood pressure <100 mmHg

 Plan for revascularization

 Greater than 96 hours after admission

 Reversible etiology of acute heart failure such as myocarditis, acute myocardial infarction, arrhythmia. Acute MI is defined as symptoms and major electrocardiogram (ECG) changes(i.e., ST segment elevations), and arrhythmia includes unstable heart rates above 120/min or below 50/min.

 Hypertrophic obstructive cardiomyopathy, constrictive cardiomyopathy, endomyocardial fibroelastosis

 Known severe congenital heart disease (such as uncorrected tetralogy of fallot or transposition of the aorta)

 Severe aortic or mitral stenosis or severe rheumatic mitral regurgitation.

 Renal impairment (defined by creatinine >3 mg/dL) at screening or on any type of dialysis.

 Known hepatic impairment (total bilirubin >3mg/dl) or increased ammonia levels at screening.

 History of systemic lupus erythematous.

 Stroke or TIA within 2 weeks from screening.

 Women who are pregnant or lactating.

 Allergy to organic nitrates.

 History or presence of any other diseases (ie. Including malignancies or AIDS) with a life expectancy of < 12 months

['Acute Heart Failure', 'Left Ventricular Dysfunction']

Acute Heart Failure
Left Ventricular Dysfunction


Studies of Disorders in Antibody Production and Related Primary Immunodeficiency States

Summary: This study investigates gene abnormalities in Primary Immune Deficiency(PID) with a goal of improving the diagnosis and treatment of patients.~The specific disorders include:~X linked hyper IgM Syndrome which is caused by an abnormality in the CD40L gene.~NEMO associated immune deficiency which is caused by an abnormality in a gene called NEMO.~Common variable immunodeficiency (CVID) which has an unknown genetic basis.~Other disorders of immunoglobulin production.~This study will:~Better characterize the clinical features of CD40 L deficiency and NEMO associated immune deficiency and other related primary immune deficiency syndromes.~Determine the frequency of CD40 L and Nemo abnormalities.~Determine whether particular abnormalities in these genes are associated with more of less severe illness or with specific symptoms.~Explore the basic mechanism by which these altered genes cause immune dysfunction.~Identify other genes causing low immune globulin levels and related primary immune deficient states.
Inclusion criteria: inclusion criteria:

 All patients must have a known or suspected immune defect with hyper-IgM syndrome and/or disorders of immunoglobulin production. There will be no limit on age, sex, race, or disability. Normal volunteers must be healthy adults between the age of 18 and 70 years. All study participants enrolled on to this study must agree to allow PI to store research samples. Refusal to let PI store samples may lead to withdrawal fro this specific study.

Exclusion criteria: :

 The presence of an acquired abnormality, which leads to immune defects, such as HIV, chemotherapy, and malignancy are general

['Hyper-IgM Syndrome', 'Ectodermal Dysplasia']


BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder

Summary: To assess the prevalence of Metabolic Syndrome in Spanish population with Bipolar I or II Disorder.~To analyse the clinical progress disease in patients with Bipolar I or II Disorder for 12 months using the assessment of the symptoms disease and the progress of metabolic and cardiovascular risk.~To analyse the health status, quality of life and functioning/disability of patients.
Inclusion criteria: inclusion criteria:

 Patients with diagnosis of Bipolar Disorder (DSM-IV TR)

 Patients or their legal representatives have provided informed consent

Exclusion criteria: :

 Patients are unable to complete or to understand health questionnaires in Spanish language

 Patients enrolled in clinical trials or other studies


Hyperbaric Oxygen and Fibromyalgia: Randomised Prospective Clinical Trial

Summary: The aim of the study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on patients suffering from chronic pain syndrome (Fibromyalgia).
Inclusion criteria: inclusion criteria:

 fibromyalgia diagnosed by physical examination of pain sensitivity, by Dolorimeter and finger pressure.

Exclusion criteria: :

 any past hyperbaric oxygen therapy

 chest x-ray pathology which does not allow the income into the hyperbaric chamber.

 middle ear problems.

 patients, who cannot pump, equals middle ear pressure, effectively.

 patients who suffer from claustrophobia.

 inability or Refusing to sign the Informed Consent Form


Prophylactic Use of Levosimendan Versus Milrinone in Open Heart Surgery in Infants

Summary: Pediatric patients, especially infants undergoing open heart surgery have a predictable fall in cardiac index 6 to 18 hours after surgery, the so-called low cardiac output syndrome (LCOS). Patients, who have LCOS require more monitoring, more medication and a longer stay in intensive care unit. To prevent LCOS the phosphodiesterase inhibitor milrinone is routinely used during the first 24 hours after surgery. Levosimendan, a calcium- sensitizer improves cardiac muscle contractile force, vascular smooth muscle relaxation and coronary blood flow through calcium sensitization of the myocardial contractile filaments and opening of potassium channels without increasing oxygen consumption of the heart muscle cells. As the myocardium of infants is more calcium dependent than in later life, levosimendan should be of special benefit in this age group. The purpose of this study is to investigate whether levosimendan is superior to milrinone in preventing LCOS in infants after corrective open heart surgery.
Inclusion criteria: inclusion criteria:

 Age younger than one year

 corrective open heart surgery with biventricular repair, except tetralogy of fallot

Exclusion criteria: :

 Missing written consent of parents

 Weight less than 3 kg

 preoperative LCOS

 gestational age less than 36 weeks

 preexisting renal failure

 preexisting thrombopenia

 preoperative cardiopulmonary resuscitation

 preoperative use of milrinone or levosimendan


A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting

Summary: The purpose of this study is to investigate if blue light cystoscopy with Cysview improves detection of tumors in patients with bladder cancer during surveillance cystoscopy, using the KARL STORZ D-Light C PDD Flexible Videoscope System. Another purpose is to investigate if Cysview and blue light is safe and effective when used repeatedly.
Inclusion criteria: Patients with bladder cancer in follow-up for tumor recurrence (Note: Patients must be included only at the first surveillance cystoscopy after a histologically confirmed tumor. The histologically confirmed tumor could either be from a TURB or from a surveillance cystoscopy where a biopsy was taken and a tumor was confirmed by histology)

 History of one or more of the following:

 Multiple tumors

 Recurrent tumors

 High grade tumor(s)

Exclusion criteria: :

 Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in significant amounts of blood in the urine, which may visually limit cystoscopy. Where the haematuria is light, the patient should not be excluded, if in the investigator's opinion, rinsing and/or electro-cautery during cystoscopy will alleviate the haematuria limitations to cystoscopy)

 Patients who cannot undergo in-office or operating room cystoscopy (Note: Training patients are eligible even if they cannot undergo operating room cystoscopy)

 Patients who have received Bacillus Calmette-Guérin (BCG) immunotherapy or intravesical chemotherapy within the past 6 weeks prior to the procedure

 Porphyria

 Known allergy to hexaminolevulinate hydrochloride or a similar compound

 Pregnancy or breast-feeding (all women of child-bearing potential must document a negative urine pregnancy test before study inclusion and use adequate contraception during the study

 Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days

 Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol

 Patients that the investigator believes are unlikely to comply with the protocol, e.g. mental condition rendering the patient unable to understand the nature, scope, and possible consequences of participating in the clinical study, uncooperative attitude or unlikelihood of completing the study

['Hexaminolevulinate hydrochloride', 'KARL STORZ D-Light C PDD Flexible Videoscope System']


Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI

Summary: The aim of this project is to evaluate the effects of the anticonvulsant drug lamotrigine (trade name Lamictal) on neuropathic facial pain or neuralgia using functional magnetic resonance imaging (fMRI).
Inclusion criteria: inclusion criteria:

 18-60 years of age

 Right-handed non-smokers

 Diagnosed with facial pain

 Continuous pain for more than 3 months

 Spontaneous pain greater than 3 of 10

 Allodynia to brush greater than 5 of 10

Exclusion criteria: :

 Medications

 Depression

 Significant medical problems

 Claustrophobia

 Abnormal EKG

 Significant drug or alcohol history

 Positive drug screen

 Weight greater than 285 lbs

 History of allergy to anticonvulsants

 Tattoos with metallic ink on upper body

 Any neurostimulator devices, or metal cochlear, ocular, or cardiac implants or other metal near vital areas

 Exposure to shrapnel or metal filings

 Other metallic surgical hardware

['Lamotrigine', 'Placebo (for Lamotrigine)']


Effects of Two Anti-HIV Drug Regimens on Quality of Life and Health Care Use Among SMART Study Participants

Summary: The purpose of this study is to compare the effects of two different anti-HIV drug regimens on quality of life and health care utilization among SMART study participants.
Inclusion criteria: inclusion criteria:

 Coenrollment in the SMART study

 Parent or guardian willing to provide informed consent, if applicable
Exclusion criteria:


Comparison Between White Light Endoscopy and Bright Narrow Band Imaging in Diagnosis Colonic Adenomas.

Summary: Removal of colorectal adenomas prevents the occurence of colorectal cancers. The use of chromo-endoscopy has been shown to improve the detection of flat adenomas. Narrow band imaging enables endoscopists to accurately describe the pit pattern of adenomas. By comparing White Light Endoscopy and Bright Narrow Band Imaging it will show if there is any comparable advantage to using one or the other for lesion detection and assessment.
Inclusion criteria: inclusion criteria:

 Asymptomatic subjects undergoing screening colonoscopy, age > 50, average risk subjects and, ability to provide a written consent to trial participation.

Exclusion criteria: :

 personal history of inflammatory bowel disease, colon adenoma or cancer

 family history of FAP or Familial nonpolyposis syndrome

 first degree relatives having diagnosed to have colorectal carcinoma

 no colonoscopy in past 5 years

['Bright Narrow Band Imaging.', 'White Light Endoscopy']

Bright Narrow Band Imaging.
White Light Endoscopy


Norplant and Irregular Bleeding/Spotting

Summary: Irregular or prolonged menstrual bleeding and/or spotting are common side effects in patients using progestin-only hormonal contraception such as levonorgestrel implants (Norplant). Doxycycline, a drug approved by the Food and Drug Administration (FDA) to treat gum disease, may reduce the occurrence of uterine bleeding and spotting in women who use Norplant. This study will evaluate the effects of doxycycline on uterine bleeding/spotting in women using Norplant.
Inclusion criteria: inclusion criteria

 Regular menstrual periods for the last 2 cycles

 Currently not using hormonal contraceptives, including oral contraceptives, patch, ring, or Norplant in 2 months prior to study entry, or Depo-Provera in 12 months prior to study entry

 Currently not using tetracycline-class antibiotics

 Normal Pap smear

Exclusion criteria:

 Pregnancy or breastfeeding within 2 months of study entry

 Chronic migraine headaches

 Uncontrolled high blood pressure

 Untreated sexually transmitted diseases

 Alcoholism or drug abuse within 12 months of study entry

 Insulin dependent diabetes

 Liver, kidney, or gallbladder disease

 Participation in another clinical trial within 30 days of study entry

 History of cancer

 History of blood clots, strokes, or heart disease

['Endometrial Bleeding', 'Periodontal Disease']

Endometrial Bleeding
Periodontal Disease


Differentiation of Malig. & Ben. Solitary Pulm. Nodules & Prediction of Clin. Outcome Using Perfus. Analysis of DCEMRI

Summary: The purpose of our study is to determine whether contrast-enhanced dynamic MRI (DCE MRI) analysis of tumor angiogenesis and perfusion can be used as a reliable modality to differentiate benign from malignant solitary pulmonary nodules (SPN) before surgical intervention, using kinetic model derived from DCE MRI, and further correlate if there is any positive correlation between angiogenesis factor (vascular endothelial growth factor VEGF, microvessel density MVD); and if the perfusion parameters from DCE MRI can predict patients' outcomes and survival.
Inclusion criteria: inclusion criteria:

 patients who have solitary pulmonary nodules in CT

Exclusion criteria: :

 patients who don't fit the above inclusion criteria


Abdominal Compression Elastic Support (ACES)

Summary: Hemodialysis (HD) patients with end stage renal disease (ESRD) experience higher rates of cardiovascular (CV) morbidity and mortality than do the general population and many populations with other chronic diseases. This exceptional risk is explained in part by known risk factors, such as diabetes, hypertension, and other uremia-related factors, including vascular calcification and stiffness, autonomic dysfunction, and a high burden of circulating inflammatory mediators. Recent studies suggest that blood pressure variability, especially intra-dialytic hypotension (IDH) is the most significant risk factor for these CV events. Studies have also shown that the use of IAB is capable of improving cardiovascular function for avoiding or minimizing the development of an orthostatic hypotensive episode (OHE) in patients with autonomic dysfunction, orthostatic hypotension (OH) in diabetes patients and children with orthostatic intolerance, and post-dialytic orthostatic hypotension (PDOH).~The investigators propose a study to examine the use of an abdominal compression elastic support (ACES) to prevent the development of IDH in patients who are known to be prone to these episodes. The ultimate goal is to facilitate more effective and safer dialysis therapy. The ACES has a configuration that is similar to a back-support work belt or an inflatable abdominal band (IAB). All of these devices are wrapped around to compress the abdomen at the waist.
Inclusion criteria: inclusion criteria:

 Must be able to give informed consent for participation in this study

 Age ≥ 18 years

 A body weight > 100 lb or a body mass index > 18.5.

 End-stage renal disease with hemodialysis in-center three times per week

 Not missing any treatments in the preceding two weeks and in compliance with instructions from the health care provider.

 In the last month had at least two episodes of IDH (defined as having hypotensive symptoms such as dizziness, fainting, headache, nausea, vomiting, cramping, weakness, blurry vision and/or a decrease in systolic blood pressure (SBP) of more than 20 mmHg).

 Hemoglobin greater than or equal to 9.0 g/dL (hematocrit 27%) to hemoglobin of 15.0 g/dL (hematocrit 45%).

Exclusion criteria: :

 • Pregnancy (self-reported)

 Allergic to nylon, polyesters and latex.

 Not able to understand the English language

 Not able to disengage the ACES from compression

 Having an excessively low systolic blood pressure (SBP which is less than 90 mmHg)

 Hemoglobin less than 9.0 g/dL or greater than 15 g/dL

 Excessive intra-abdominal fluid pressure

 Respiratory distress

 Bleeding in the chest and abdomen

 Bleeding dyscrasia causing serious coagulation problem

 Raised intra-abdominal pressure

 Having the following cardiovascular, pulmonary and abdominal complications:

 Systolic congestive heart failure, defined as a systolic ejection fraction of less than 25%

 Coronary artery disease defined as having a history of myocardial infarction or hemo-dynamically significant stenosis on cardiac catheterization or acute or chronic angina

 Circulatory shock

 Head trauma and/or abdominal trauma in the past three months

 Mesenteric ischemia

 Active foot ulcer

 Pulmonary edema

 Uncontrolled Hypertension (defined as systolic pressure of 180 mm Hg or a diastolic pressure of 110 mm Hg or higher) - using the average blood pressures obtained at one prior recent dialysis session and the average blood pressures obtained at the screening trial session for ACES.

 Liver disease as defined as an elevated ALT, AST, and Alkaline Phosphatase 2.5 times the upper limit of normal on a prior lab from medical records.

 INR > 1.5 or use of coumadin

 Platelets < 100

 Active infection

 The need to use anti-hypotensive drugs on the days the ACES belt is applied.

 If the average systolic blood pressure with anti-hypotensive drugs or without and made before hemodialysis treatment is less than 90 mmHg, then the ACES session will be postponed to the next treatment. If similar hypotension situation occurs in the next ACES/hemodialysis treatment, then the subject will be taken out of the ACES trial and be considered a screen fail.

['Abdominal Compression Elastic Support']


The Effectiveness of Individualised Bone Density Feedback and Osteoporosis Education in Premenopausal Women

Summary: The purpose of this study is to determine whether giving women feedback concerning their bone mineral density, combined with either an information leaflet or group education concerning osteoporosis changes women's behavior and/or bone density.
Inclusion criteria: inclusion criteria:

 women aged between 25 and 44 years of age

Exclusion criteria: :

 previous had measurement of bone densitometry

 thyroid disease

 renal failure

 malignancy

 rheumatoid arthritis

 history of hysterectomy

 hormone replacement therapy

 were pregnant or planning pregnancy within 2 years of study entry

 lactating.

['individualised bone density feedback and education']


Overlooked Population at Risk for AIN.

Summary: The purpose of this study is to determine the possibility and compliance of performing anal Pap smear and Human Papilloma Virus (HPV) DNA testing on women with high grade lower genital tract dysplasia or cervical cancer and determining the prevalence of anal dysplasia in this population using a high-resolution anoscopy (HRA). In addition, it is being done to potentially develop screening, diagnostic and treatment protocol for anal dysplasia in women with high-grade lower genital tract dysplasia or cervical cancer.
Inclusion criteria: inclusion criteria:

 Women ≥ 40 years old

 Previous or current high grade cervical dysplasia or cervical cancer

Exclusion criteria: :

 Women ≥ 40 years old because the median time between the diagnosis of anal cancer and previous cervical cancer is approximately 20 years.

 chemotherapy or radiation therapy within the last 6 months

['Screening Anal Pap Smear - No High Resolution Anoscopy', 'Screening Anal Pap Smear - With High Resolution Anoscopy']

['High Grade Cervical Dysplasia', 'Cervical Cancer']

High Grade Cervical Dysplasia
Cervical Cancer


Resistance Exercise Effects on Fear Avoidance and Physical Function in Obese Older Adults With Low Back Pain

Summary: The purpose of this study is to determine if a 4 month resistance exercise program reduces the severity of low back pain, pain-related fear avoidance and improves mobility compared to standard care.
Inclusion criteria: inclusion criteria:

 chronic low back pain for >6 months

 >3 pain episodes per week

 waist circumferences ≥102 cm for men

 waist circumferences ≥ 88 cm for women

 willing and able to participate in regular exercise for 14 weeks

 using pain medications to control low back pain

 free of abnormal cardiovascular responses during a screening graded maximal walk test

Exclusion criteria: :

 unable to walk

 participating in regular resistance exercise training (>3X week) in the past 6 months

 pain symptoms are too severe and prevent strength testing or walking

 acute back injury

 spinal stenosis that precludes walking one block due to neurogenic claudication

 back surgery within the past 2 years

 current use of weight loss interventions (drugs; exercise interventions)

['normal medical care and follow up', 'Isolated Lumbar Resistance Exercise Program', 'Total Body Resistance Exercise Program']


Clinical Evaluation of the SNaP Wound Care System in Promoting Healing in Chronic Wounds

Summary: The purpose of this study is to evaluate a novel topical negative pressure (TNP) wound therapy device called the SNaP® (Smart Negative Pressure) Wound Care System for the treatment of lower extremity diabetic, venous and mixed aetiology leg wounds.
Inclusion criteria: inclusion criteria:

 Patient has diabetic foot ulceration, venous ulcer, or mixed aetiology ulcer with a surface area <100 cm2 and <10 cm in widest diameter on lower extremity, but larger than 1 cm2 (venous and mixed aetiology ulcers will be defined by clinical exam of treating physician. Diabetic foot ulcers will be defined by clinical exam of the treating physician and as lower extremity ulcers in patients with a diagnosis of diabetes, but without venous stasis disease).

 Wound present for >30 days.

 Patient has wound in location amenable to creation of airtight seal around wound using TNP dressings.

 Patient is able to comply with study protocol requirements.

 Patient is able to understand and provide written consent.

Exclusion criteria: :

 Patient has evidence of wound infection in the opinion of the physician.

 Patient has a thick eschar that persists after wound debridement.

 Patient has an HbA1C >12%.

 Patient has ulcers due to inflammatory conditions such as pyoderma gangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinaemia, necrobiosis lipoidica, panniculitis, lupus erythematosus, scleroderma, or calcinosis.

 Patient has untreated osteomyelitis.

 Patient has any other condition that, in the opinion of the investigator, makes the patient inappropriate to take part in this study.

 Patient is allergic to the wound care device or occlusive dressing.

 Patient has exposed blood vessels.

 Patient is pregnant or pregnancy is suspected.

 Patient is actively participating in other clinical trials that may interfere with their participation in this study.

['Lower Extremity Diabetic Leg Wounds', 'Lower Extremity Venous Leg Wounds', 'Lower Extremity Mixed Aetiology Leg Wounds']


Bedside Lung Ultrasound in Young Children Presenting to the Emergency Department (ED) With Wheezing

Summary: Young children presenting to the Emergency Department (ED) with wheezing often have prolonged stays in the ED or even get admitted to the hospital. This is a prospective observational study in which the investigators will use bedside 2D ultrasound to evaluate the lung ultrasound findings in children less than 24 months presenting to the ED with wheezing.~The investigators hypothesize that children less than 24 months presenting to the Emergency Department with wheezing will have a range of lung ultrasound findings that will include normal findings, B lines, subpleural consolidations, and pleural effusions. The investigators also hypothesize that the findings will be reproducible between two equally trained providers.~The investigators also hypothesize that lung ultrasound findings patients 0-24 months presenting to the ED with wheezing will correlate with specific clinical outcomes. An exploratory analysis will be performed to look for correlations between lung US findings and acute severity, final diagnosis, presenting symptoms, prematurity, risk factors for atopy, response to treatment and radiologic or viral studies if performed.
Inclusion criteria: inclusion criteria:

 Age less than or equal to 24 months

 Presenting to the pediatric ED with wheezing

Exclusion criteria: :

 On home oxygen at baseline

 Cyanotic congenital cardiac disease (including: ToF, TAPVR, HLHS, d-TGA, TA, pulm atresia, critical pulm stenosis, but not including VSD, ASD, Coarctation of the Aorta)

 Endotracheal tube or tracheostomy in place and/or receiving mechanical ventilation

 Transferred from an outside hospital


Cutaneous Lupus Medication Experience Study

Summary: Cutaneous lupus is a chronic, relapsing, auto-immune skin disease that can have many presentations. Its effect on physical appearance greatly affects patients' quality of life. In addition, 10% of patients with cutaneous lupus will develop systemic lupus. Topical therapies are the mainstay of cutaneous lupus treatment; however patients often find these treatments to be messy, inconvenient, or ineffective. In addition, for more severe disease patients are often placed on concurrent systemic therapies. The primary hypothesis of our study is that poor adherence contributes to poor treatment outcomes in patients with cutaneous lupus.
Inclusion criteria: inclusion criteria:

 Any male or female 12 years or older of age with a diagnosis of cutaneous lupus by a dermatologist

 Capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed

 Able to complete the study and comply with study instructions, including attending all study visits

Exclusion criteria: :

 Individuals younger than 12 years of age

 Known allergy or sensitivity to study medication

 Inability to complete all study-related visits

 Introduction of any other prescription medication, topical or systemic, for cutaneous lupus while participating in the study


Prediction of Response to Neoadjuvant Therapy in Rectal Cancer

Summary: The purpose of this study is to determine whether 18F-FDG-PET-CT and texture analysis of MRI performed 9 weeks after Neoadjuvant Chemo-radiotherapy in patients with locally advanced rectal cancer has the ability to identify patients with Complete Response.
Inclusion criteria: inclusion criteria:

 Patients with biopsy-proven confirmed rectal cancer

 MRI stage: T3/T4 and/or N1/N0.

 No contraindication to MRI and PET-CT.

Exclusion criteria: :

 Contraindication to MRI and/or PET-CT.

 Inability to consent.

 Severe claustrophobia.

 Distant metastases.

 Synchronous tumour.


Sonography Outcomes Assessment Program for Lower Extremity Deep Venous Thrombosis

Summary: Currently, most emergency physicians have limited access to obtaining formal radiology ultrasound studies, particularly overnight. Many are forced to adopt risky and expensive strategies in managing their patients with suspected deep venous thrombosis (DVT) who present during off-hours: for low risk patients, discharging without anticoagulation and arranging for outpatient studies; for moderate to high risk patients, empirically anticoagulating and admitting to the hospital to await definitive testing. If emergency physicians could reliably perform an accurate ultrasound exam for DVT, such risks could be obviated.~This is a prospective, observational cohort study assessing the accuracy of emergency physician diagnosis of proximal DVT using compact ultrasound equipment and a simplified compression technique. The value of color flow doppler and augmentation will also be assessed. Outcomes (sensitivity, specificity, positive likelihood ratio and negative likelihood ratio) will be assessed at 30 days.~Prior to enrolling patients in the study, emergency physicians will undertake a 2 hour training course on the performance of the simplified compression technique for the diagnosis of lower extremity DVT. Emergency physicians will perform the DVT ultrasound exam on study subjects with suspected DVT. Clinical management of the study subjects will not be altered; all subjects will proceed to receive a formal DVT ultrasound study by the radiology department which will serve as the criterion reference for the study.
Inclusion criteria: inclusion criteria:

 inclusion criteria:

 Presenting signs and symptoms sufficiently suspicious for lower extremity DVT to warrant a formal radiology study in the opinion of the treating physician AND EITHER 2a. Moderate or high pre-test clinical probability of DVT (Wells Criteria) OR 2b. Low pre-test clinical probability of DVT with a positive D-dimer

Exclusion criteria: :


A Trial of 2 'Point of Care' Diagnostic Methods to Improve Detection and Treatment of Anaemia in African Children

Summary: A high proportion of children under the age of 5 years and pregnant women in Tanzania is anaemic, particularly in areas of high malaria transmission. The symptoms of anaemia are often non-specific or absent and clinical judgement is generally insensitive in estimating Hb levels, especially in infants who are assessed by basic grade health staff. Thus while treatment for the common causes of anaemia is available, many cases are not treated due to difficulties in recognising anaemia.~New diagnostic tools can increase the sensitivity of anaemia detection compared to clinical diagnosis but no studies have demonstrated their effectiveness in increasing case-detection and treatment of anaemic patients at the first level of healthcare. In addition, the costs of their use in relation to any increase in numbers of cases treated are not known and this knowledge is needed to guide public health decisions.~Two methods of measuring anaemia are currently suitable for use at the first level of care; Copack Haemoglobin colour scale (HBCS) and Hemocue portable photometry. We propose to compare the effectiveness in basic health facilities of these 2 simple diagnostic tools compared to control dispensaries (current practice) in increasing rates of detection and treatment of anaemia in children under the age of 5 years and pregnant women over the course of 1 year in a cluster-randomised trial in 30 dispensaries in a malaria-endemic area of NE Tanzania.
Inclusion criteria: inclusion criteria:

 Age under 5 years

 Pregnancy

 Suspected anaemia
Exclusion criteria:


Tetravalent Chimeric Dengue Vaccine Trial

Summary: The purpose of this study is to test the safety and immune response to a live attenuated dengue vaccine that could protect people against all 4 types of dengue virus. Live attenuated means that while this vaccine contains 4 live dengue viruses the viruses have been attenuated (weakened) so as not to cause dengue disease in people. Dengue virus is spread to people by mosquitoes and can cause sickness and even death. Seventy-two subjects between the ages of 18-45 years old will be enrolled in this research study at Saint Louis University Center for Vaccine Development. Participants will be randomly assigned to 1 of 4 groups to receive 2 doses of the study vaccine or placebo (inactive substance). Study procedures include: maintaining a diary to record temperature and side effects, physical exam, electrocardiogram (ECG) (measures the activity of the heart), and blood samples. Participants will be involved in study related procedures for about 10 months.
Inclusion criteria: inclusion criteria:

 Male or female at least 18 and less than or equal to 45 years old at time of screening.

 In good health as determined by medical history, physical examination including height and weight, and clinical safety laboratory examinations. For creatinine and alkaline phosphatase levels the applicable cut-offs for determination are the upper limits of normal only, as there is no clinical significance associated with results below the lower limits of normal for these laboratory values. For aspartate aminotransferase (AST) and alanine aminotransferase (ALT), the applicable cut-offs for determination are less than 1.5 times the upper limits of normal, as there is no clinical significance associated with results below the lower limits of normal for these laboratory values or with mild elevations above the upper limits of normal.

 Laboratory values not listed in Table 3 which are obtained as part of a reference laboratory pre-determined panel will be considered as acceptable for enrollment if they are either within reference laboratory normal range or within the ranges specified for a grade I AE per the protocol Toxicology Tables in Appendix B. Values within reference laboratory normal ranges or within ranges specified for a grade I AE per the Toxicology Tables in Appendix B will be considered as discussed with the medical monitor and may be enrolled with no further discussion. Values with deviations outside the ranges specified for a grade 1 AE in the Toxciology Tables in Appendix B will be discussed further between the PI and the medical monitor prior to vaccination and assessed for impact on volunteer safety. Urinalyses obtained from female volunteers on their menses may be repeated after their menses have concluded without discussion with the medical monitor. Laboratory values which are not listed in the Toxicology Tables in Appendix B and which are out of the reference laboratory normal range will be discussed with the DMID medical monitor to determine its relevance for safety and impact on enrollment and follow-up vaccinations.

 Blood tests negative for antibodies to human immunodeficiency virus (HIV)-1, Hepatitis C, dengue, West Nile, and negative for Hepatitis B surface antigen.

 No history of dengue or West Nile infection or participation in a previous dengue or West Nile vaccine trial.

 Females of child bearing potential must have a negative urine pregnancy test result during screening and a negative urine pregnancy test immediately prior to vaccination and be willing to use oral, implantable, transdermal or injectable contraceptives or another reliable means of contraception approved by the Investigator (intrauterine device, female condom, diaphragm with spermicidal, cervical cap, use of condom by the sexual partner or a sterile sexual partner, or abstinence) from screening until after the last blood sample (at day 270).

 Willing and able to give written informed consent to participate.

 Willing and able to communicate with the investigator and understand the requirements of the study.

 Electrocardiogram (ECG) in absence of clinical significance (e.g., complete left or right bundle branch block, incomplete left bundle branch block or sustained ventricular arrhythmia, or two premature ventricular contraction's (PVC's) in a row, or ST elevation consistent with ischemia).

 Weight: greater than or equal to 110 lb.

 Access to a fixed or mobile telephone.

Exclusion criteria: :

 Any condition which would limit the subject's ability to complete the study in the opinion of the Investigator.

 Clinically significant hematological, renal, hepatic, pulmonary, central nervous, cardiovascular, thromboembolic, autoimmune, coagulopathic, or gastrointestinal disorders or history of such disorders

 Any history of malignancy with the exception of basal cell carcinoma.

 Previous history , or current diagnosis of diabetes mellitus.

 Pulse >95 or <40 at rest or irregular, systolic blood pressure (bp) >170 or <90 at rest or diastolic bp >90 or <50 at rest, body temperature >100 F, respirations >25 per minute at rest.

 History of allergy to penicillin, neomycin, streptomycin or gentamicin.

 History of hypersensitivity to any vaccine.

 History of previous vaccination with Yellow Fever (YF) vaccine or Japanese Encephalitis (JE) vaccine or planned receipt of either YF or JE vaccine during the course of the study.

 Previous history of infection with dengue or West Nile or seropositive antibody status to dengue or West Nile virus or participation in a vaccine trial for either of these.

 Travel or planned travel to a dengue-endemic area including the Caribbean, Mexico, Central America, South America or Asia during the study period or in the month prior to screening. An updated map of dengue endemic areas is available at the CDC Yellow Book 2010 website (http://wwwnc.cdc.gov/travel/yellowbook/2010/chapter-5/dengue-fever-dengue-hemorrhagic-fever.aspx) and a list of dengue endemic countries is provided in the Manual of Procedures (MOP).

 Travel to a dengue endemic area within 1 month of screening. Volunteers who have a history of recent travel to a dengue endemic area may screen if they have returned to the US 30 or more days prior to the screening visit.

 Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term (at least 2 weeks within the previous 3 months) systemic corticosteroids therapy (at a dose of at least 0.5 mg/kg/day). Intranasal or topical prednisone (or equivalent) are allowed.

 Personal history of recurring migraines or on prescription medication for treatment of recurring headaches or migraines.

 Use of any non-steroidal anti-inflammatory drugs (NSAIDs), including any aspirin-containing products, acetaminophen or systemic, topical, or intranasal antihistamines for the 3 days immediately prior to each vaccination. Systemic antihistamines may not be used at all during the first 21 days after each vaccination.

 During the first 14 days after each vaccination, anti-inflammatory drugs (NSAIDs) or acetaminophen may be used only if the subject has a fever >/= 100 F or if the subject has significant arm pain, myalgia, arthralgia, or headache and only after documenting the symptom in the memory aid. Intranasal or topical antihistamines may be used during the first 14 days after each vaccination only if the subject has significant allergy symptoms such as rhinitis, cough, eye inflammation, or pruritis and only after documenting the symptom in the memory aid. Intranasal or topical antihistamines, NSAIDs or acetaminophen should only be taken after documentation of symptoms or fever in the memory aid and should not be taken prophylactically.

 Receipt of any other investigational product in the month before study entry and during the entire study duration.

 Receipt or planned receipt of any licensed vaccine in the 4 weeks preceding either trial vaccination (2 weeks for inactivated vaccines) or planned receipt of any vaccine in the 4 weeks following each of the trial vaccinations.

 Concurrent or planned participation in any other clinical study during the conduct of this study.

 Receipt of blood products or immunoglobulins 8 weeks before study entry or planned use during the study period.

 Donation of blood 6 weeks before study entry or at any time during the study.

 Laboratory screening test result that is not within protocol specified normal range (Table 3 of protocol).

 Females who are pregnant or lactating.

['Placebo (SC)', 'Placebo (ID)', 'Modified Live Tetravalent Chimeric Dengue Vaccine (SC)', 'Modified Live Tetravalent Chimeric Dengue Vaccine (ID)']


Sexual Behavior in Head and Neck Cancer Patients

Summary: The goal of this behavioral research study is to learn if certain sexual behaviors increase the risk for developing head and neck cancers associated with a virus called human papillomavirus (HPV-16). Knowing this information could help doctors better teach patients about avoiding certain risk factors, which may help to prevent the disease.
Inclusion criteria: inclusion criteria:

 Patients with newly diagnosed, previously untreated squamous cell carcinoma of the head and neck (SCCHN) who are candidates for the molecular epidemiology study LAB00-062 of head and neck cancer.

 Must have the ability to understand and provide informed consent.

 Patients must be 18 years and older.

 Ability to read, write, and speak English.

 Resident of the United States.

 Agrees to have tumor tissue, if available, tested for HPV. No additional biopsy will be requested.

Exclusion criteria: :

 Previous cancer diagnosis excluding non-melanoma skin cancer.

 Blood transfusion within the previous 6 months.

 Immune suppression, such as HIV disease or immune-suppressing therapy (i.e., steroids).

['Oropharyngeal Cancer', 'Head and Neck Cancer', 'Squamous Cell Carcinoma']

Oropharyngeal Cancer
Head and Neck Cancer
Squamous Cell Carcinoma


To Determine if Sleep Deprivation Results in Increased Esophageal Acid Exposure

Summary: The purpose of this study is to determine if sleep deprivation results in increased esophageal acid exposure in healthy controls and gastroesophageal reflux disease (GERD) patients.
Inclusion criteria: inclusion criteria:

 Male/Female - 18-80

 2 or more episodes of heartburn a week for last 3 months

Exclusion criteria: :

 Previous upper GI surgery

 Underlying co-morbidity

 Narcotic medications

 Psychotropic's and Benzodiazapines medications

 Hx of psychological abnormalities

 Hx of ETOH in previous 6 mos.

 Diabetes Mellitus

 Neuropathy

 Seizures

 Sleep Apnea

 Co-morbidity that interfere w/sleep

 Women who are pregnant, or childbearing yrs, not on BC


Nimotuzumab in Combination With Radiotherapy 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 II study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with radiotherapy in patients with esophageal cancer tumours.
Inclusion criteria: inclusion criteria:

 pathologically or cytology diagnosed phase II-III esophageal carcinoma or IV thoracic segments carcinoma with the supraclavicular lymph nodes metastasis.

 with the measureable lesion of the newly diagnosed the esophageal carcinoma.

 age 18-75 years old

 ECOG≤2

 Expect survival date ≥3 months

 without serious diseases of important organs

 signature in the inform consent.

Exclusion criteria: :

 pregnant or breast-feeding women or using a prohibited contraceptive method.

 with psychiatric diseases.

 with serious diseases or uncontrolled infection.

 with history of other tumors.

 participation other clinical trials within 1 month prior to inclusion in the trial.

 not the first antitumor treatment .


Efficacy of Intensity Modulated Radiation Therapy After Surgery in Early Stage of Esophageal Carcinoma;

Summary: The purpose of this study is to determine the efficacy of preventive intensity modulated radiation therapy after surgery in stage T2-3N0M0 disease of thoracic esophageal squamous cell carcinoma(UICC 7th edition) and to identify the subgroup benefiting from the treatment.
Inclusion criteria: inclusion criteria:

 Stage T2-3N0M0 disease of TESCC patients confirmed by pathology studies who received R0 operations in Cancer Institute & Hospital，CAMS；

 KPS≥70 before radiotherapy;

 Did not receive neoadjuvant or adjuvant treatment;

 No clear recurrent or metastatic lesions before radiotherapy;

 Intensity modulated radiation therapy(IMRT) is accepted;

 Regular follow-up.

Exclusion criteria: :

 Exploratory thoracotomy or palliative surgery;

 No clear recurrent or metastatic sites;

 Recurrence or metastasis is not certain;

 death of no definite cause.

 Irregular follow-up;

['Prophylactic postoperative radiation therapy']

['Esophageal Neoplasm', 'Esophageal Cancer TNM Staging Primary Tumor (T) T2', 'Esophageal Cancer TNM Staging Primary Tumor (T) T3', 'Esophageal Cancer TNM Staging Regional Lymph Nodes (N) N0', 'Esophageal Cancer TNM Staging Distal Metastasis (M) M0']


Induced Hypertension for Treatment of Delayed Cerebral Ischaemia After Aneurysmal Subarachnoid Haemorrhage

Summary: The objective of this multi-centre, randomized controlled trial is to investigate the outcome after induced hypertension versus no induced hypertension in patients with delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage (SAH), and to assess whether induced hypertension results in improved cerebral blood flow (CBF) as measured by means of perfusion-CT.
Inclusion criteria: inclusion criteria for eligibility

 Admission to one of the participating study centres.

 Age 18 years or over.

 SAH with an aneurysmatic bleeding pattern.

Exclusion criteria:  for eligibility

 Evidence of DCI after the SAH, defined as any decrease in the level of consciousness or the development of new focal neurological deficits after the onset of the SAH that is not due to increasing hydrocephalus, rebleeding of the aneurysm, epileptic seizure, septic- or metabolic encephalopathy, unless symptoms of DCI started within 3 hours.

 Co-existing severe head injury.

 Perimesencephalic haemorrhage (perimesencephalic bleeding pattern and no aneurysm on CT-angiography).

 A history of a ventricular cardiac rhythm disorder, necessitating medical treatment.

 A history of a left ventricular heart failure, necessitating medical treatment.

 Likely transfer to another hospital, not participating in the trial, soon after treatment for the aneurysm.

 Moribund.

 Pregnancy.

 And furthermore, in selected centres where the sub study with CT perfusion will be performed:

 Known allergy for CT-contrast agents.

 Renal failure, defined as a serum creatinine > 150 µmol/l, because of the risk of contrast nephropathy.

 Diabetes mellitus.

 inclusion criteria for trial participation

 Informed consent to participate in the proposed trial when DCI will develop.

 DCI based on a decrease of at least one point on the Glasgow Coma Scale sum score unless the decrease doesn't reflect DCI as evaluated by the treating physician, and/or the development of new focal neurological deficits, diagnosed by a neurologist, neurosurgeon or intensivist.

['Cerebral Ischemia', 'Subarachnoid Hemorrhage']

Cerebral Ischemia
Subarachnoid Hemorrhage


Comparison of Pharyngeal Oxygen Delivery by Different Oxygen Masks

Summary: The intent of this study is to determine the difference in pharyngeal oxygen concentration in patients who have a natural airway (not intubated) using commonly available oxygen delivery systems.~The investigators will test the hypothesis that oxygen concentration during the period of inspiration (FiO2) in the pharynx is dependent on oxygen delivery system design, even at high flow (15 liters/minute) oxygen delivery. Specific measurements include oxygen concentration at subjects' lips and pharynx when breathing 100% oxygen and room air via a simple mask, non-rebreather mask, OxyMaskTM, and anesthesia mask with headstrap and Jacson Rees circuit.~A mean difference of 10% pharyngeal FiO2 between any of the masks will be considered clinically important. The expected standard deviation of the within-subject FiO2 is 3.5%. With a significance criterion of 0.05, 10 subjects would provide more than 90% power to detect a mean difference of 10%.
Inclusion criteria: inclusion criteria:

 18 to 70 years of age

 Male and female volunteers

 ASA physical status I, II and III

 Capable and willing to provide written informed consent in English

Exclusion criteria: :

 Acute cardiopulmonary disease, as defined by blood pressure greater than 150/90, HR greater than 120 and room air oxygen saturation less than 92.

 Allergy to lidocaine or adhesive tape

 History or physical exam finding of nasal polyps

 Currently taking oral or parenteral anticoagulant medications (other than aspirin)

 History of frequent nose bleeds

 Current symptoms of nasal congestion

 Physical examination findings of rales or wheezing

 Facial hair that prevents forming a seal with an anesthesia mask

['Hypoxemia', 'Trauma', 'Acute Myocardial Infarction']

Hypoxemia
Trauma
Acute Myocardial Infarction


Interleukin-1 Receptor Antagonist (IL-1RA) (ANAKINRA) IN SEVERE SYSTEMIC-ONSET JUVENILE IDIOPATHIC ARTHRITIS

Summary: Main objective: To test the efficacy of anakinra treatment in children or young adults with corticosteroid-resistant or -dependent Systemic-Onset Juvenile Idiopathic Arthritis (SO-JIA)~Design: Double blind, randomized trial testing the efficacy of one month Anakinra treatment versus placebo (2 groups of 12 patients each). All the patients will be treated with anakinra during the following 11 months and the dose of corticosteroids will be gradually tapered (= descriptive part of the trial to assess the tolerance and efficacy over 12 months).~Hypothesis: 70% significant improvement after 1 month in Anakinra-treated patients versus no more than 10% in the placebo group.~Main inclusion criteria : diagnosis of SO-JIA (Durban consensus conference criteria), age: 2 to 20 years at inclusion, active, corticosteroid-resistant or -dependent disease, no previous IL-1ra treatment.
Inclusion criteria: inclusion criteria:

 SO-JIA (Edmonton's revision of Durban's consensus conference criteria)

 Age: at least 2 years and less than 20 years at treatment initiation

 Disease duration of at least 6 months

 Failure of corticosteroid treatment or requirement for corticosteroid treatment at a daily dose equal to or over 0.3 mg/kg (10 mg in patients whose weight is over 34 kg)

 Active and severe systemic symptoms and/or arthritis as assessed by an experienced pediatric Rheumatologists, with at least 3 of the following criteria when assessing Giannini's core-set items: 1) physician global assessment of disease activity of at least 20/100; 2) parent/patient assessment of disease effect on overall well-being of at least 20/100; 3) functional disability with a Children Health Assessment Questionnaire (CHAQ, Ref [9]) score equal to or higher than 0.375/3; 4) 2 joints or more with active arthritis 5) 2 joints or more with non-irreversible limited range of motion (irreversible limited range of motion will be defined by radiological evidence of irreversible joint damage and ankylosis) 6) erythrocyte sedimentation rate (ESR) equal to or higher than 20.

 In the absence of disease-related fever, either CRP or first hour ESR or both have to be over the upper limit of normal values so that treatment effect on the systemic part of the disease can be objectively evaluated.

 Patients with polyarthritis (at least 5 joints with inflammation and/or limitation of motion) will be eligible for this study only if at least 50% of the affected joints do not present radiological evidence of irreversible damage.

 Informed consent signed by the parents or the person legally responsible for the patient if the patient is less than 18, and by the patient if old enough

 Teenager girls or young women with childbearing potential must use a contraceptive method (including abstinence

 tuberculin test performed before Day 1 and must either be negative or positivity must be related to previous immunization and of normal intensity according to the investigator's judgment

Exclusion criteria: :

 Previous treatment with IL-1Ra

 intra-articular injection or change in the doses of non-steroidal anti-inflammatory drugs and corticosteroids in the 4 weeks preceding the initiation of anakinra treatment

 Treatment with another immunosuppressive or disease-modifying drugs that could not be stopped before inclusion (for a duration depending on the drug pharmacokinetic properties)

 Contra-indication to the use of anakinra including ongoing active infection or allergy to E Coli's derivate or other components of the drug

 Previous history of malignancy or heart insufficiency

 Patients with asthma require to be previously assessed by a pneumonologist

 Obvious need of therapeutic intervention before study completion such as surgery, intra-articular injection, life vaccine administration

 Any of the following: leucocyte counts < 3.6 x 10e9/L, polymorphonuclear neutrophil counts < 1.5 x 10e9/L, platelets < 150 000/mm3, serum creatinin > 1.5 the upper limit of normal range for age, serum alanine and aspartate transaminases > 2 times the upper limit of the normal range, serum bilirubin > 2 times the upper limit of the normal range

['Systemic-Onset Juvenile Idiopathic Arthritis']


Biomarkers in Acute Abdomen

Summary: Background: In the emergency setting, acute abdominal pain is a diagnostic challenge, as pain is a subjective measure, and serious causes needing surgical intervention do not always meet the clinical picture. Biomarkers measuring the individual stress or pain level may aid in identifying surgical emergencies, but there are many influencing factors that have to be taken into account.~Objective: To evaluate defined stress biomarkers for their diagnostic and prognostic utility in measuring pain, and to evaluate potential influencing or confounding factors.~Design: Prospective observational study in 200 patients presenting to the emergency department with acute abdominal pain.~Estimated duration: May 2015 - May 2016 Location Setting: Emergency Department (ED) of the Hôpital Universitaire Pitié-Salpétrière, Paris, France.~Study population: 200 patients presenting to the ED with acute abdomen~Eligibility criteria:~Inclusion criteria: Presentation at ED with acute abdominal pain, aged at least 18 years~Exclusion criteria: no informed consent, pregnancy, homeless, no social assurance~Procedure:~Patients presenting to the ED with acute abdominal pain will be included after informed consent is given. Blood and saliva samples will be drawn initially and after 4 hours, and baseline data assessed. All diagnostic procedures results and diagnosis made by the treating physicians as well as initiated treatment will be recorded Final diagnosis and outcome will be assessed by 2-week-telephone interview.~Measurement of candidate biomarkers will be performed in collected material. Copeptin and SAA will be measured as potential biomarkers, as a control value, cortisol will be obtained. Other biomarkers will be in consideration, depending upon availability and financial aspects.~Safety evaluations: All recommendations outlined in the ICH Guidelines for Good Clinical Practice will be adhered to throughout this trial.~Sample size considerations: The number of patients of this pilote study is based on the estimate of 25 % or 50 of acute abdomen patients to have a surgical emergency.~Significance of the study: If a biomarker is found that safely discriminates between surgical urgency and harmless abdominal pain, this will spare radiologic exposure in often young patients and will aid in optimized allocation of health care resources.
Inclusion criteria: inclusion criteria:

 Presentation at ED with acute abdominal pain, aged at least 18 years

Exclusion criteria: :

 No informed consent, pregnancy, homeless, no social assurance

['No intervention as observational study']


Host Responses in Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection

Summary: Hepatitis E is a worldwide disease. It is the leading or second leading cause of acute hepatitis in adults in developing countries from sub-Saharan Africa or Southeast Asia, where it is hyperendemic and principally water-borne. In industrialised western countries, hepatitis E was until recently considered as imported from hyperendemic geographical areas, but is currently an emerging autochthonous infectious disease. A growing body of data from Europe, America, Australia, and Asia strongly indicate that pigs represent a major Hepatitis E Virus (HEV) reservoir and might be a source of zoonotic transmission to humans through direct or indirect exposure. Hepatitis E typically causes self-limited acute infection. However, the overall death rate is 1-4%, and it can reach 20% in pregnant women and might be still higher in patients with underlying chronic liver disease. To date, no preventive or curative treatment of hepatitis E is available.
Inclusion criteria: inclusion criteria:

 Age > 18 years

 Transplanted by a functional kidney

 affected by a hepatitis E chronic

 Benefiting from a follow-up in the Center of Nephrology and renal Transplantation or in the service of Hépato-gastro-entérologie of the CHU The Conception in Marseille

 Having signed a consent informed about participation in the study

Exclusion criteria: :

 Affected by another sharp or chronic viral infection

['Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection']


A Study to Examine the Relationship Between Sleep Apnea and Cleft Lip/Palate

Summary: The study is to examine the relationship between sleep apnea and neurocognitive behaviors in children with cleft lip/palate. Describe the incidence and severity of obstructive sleep apnea in an unselected population of grade school aged children with surgically repaired cleft palate.~A. Is the incidence of OSA higher in children with cleft palate than age matched historical control groups? B. Are nighttime symptoms an adequate screening tool to exclude the diagnosis of OSA in children with surgically repaired cleft palate? Describe the velopharyngeal closure patterns during speech in an unselected population of grade school aged children with surgically repaired cleft palate. Describe the neurobehavioral phenotype of an unselected population of grade school aged children with surgically repaired cleft palate.
Inclusion criteria: inclusion criteria:

 100 children with cleft lip/palate and signs and symptoms of OSAS, parents who can read and write English

Exclusion criteria: :

 Parents who cannot read and write English, children with severe neurological compromise

['Obstructive Sleep Apnea Syndrome', 'Cleft Lip/Palate']

Obstructive Sleep Apnea Syndrome
Cleft Lip/Palate


Study Evaluating Streptococcus Pneumoniae Serotype Carriage Rate for Nasopharyngeal Carriage in Filipino Children

Summary: Evaluation of the carriage rate of Streptococcus pneumoniae in the nasopharynx of healthy children and the carriage rate and distribution of Streptococcus pneumoniae serotypes
Inclusion criteria: inclusion criteria:

 Healthy children aged between 2 months and 5 years attending the well baby clinic in hospital.

 Informed consent obtained from parents or legal guardian.
Exclusion criteria:


Treating Adults at Risk for Weight Gain With Interactive Technology

Summary: Obesity represents a chronic disease associated with significant cardiovascular disease (CVD) morbidity and mortality. Weight gain in young adults adversely impacts the development of CVD risk factors. Further, there is a clear relationship between weight loss in obese persons and reduction in these CVD risk factors. Unfortunately, young adults are at high risk for weight gain. Although the scientific literature contains a number of reports regarding successful weight loss efficacy studies, young adults are typically underrepresented.~Cigarette smoking is the leading preventable cause of morbidity and mortality, but quitting smoking frequently results in significant weight gain. Proactive tobacco quit lines using behavioral smoking cessation interventions combined with nicotine replacement therapy (NRT) have been shown to help persons quit smoking. However, concerns about post-cessation weight gain have been reported as a significant barrier to quitting for many smokers particularly young adults.~If an efficacious behavioral weight loss program could be combined with an efficacious behavioral smoking cessation program that prevented or significantly attenuated post-cessation weight gain, then a large public health benefit may result. Such a combined weight loss/ weight gain prevention / smoking cessation program that used targeted intervention strategies to young adults, removed barriers to participation, and utilize interactive technology should be appealing to this age group. To date such a combined program has not been tested in young adult cigarette smokers. Therefore, the objective of this clinical trial is to develop and test a behavioral weight loss / weight gain prevention intervention delivered through interactive technology that can be used in conjunction with an efficacious tobacco quit line. A total of 330 participants will be necessary to adequately address the following specific aims.
Inclusion criteria: inclusion criteria:

 The selection criteria for the clinical trial are designed to include a wide range of participants such that the study sample will be representative of the broader U.S. population of the Memphis metropolitan area. Those who might be at risk of adverse outcomes from the study interventions will be excluded (see
Exclusion criteria: ). All participants will give voluntary consent at the screening visit by signing an informed consent statement which has been approved by the Institutional Review Board (IRB). We will encourage the participation of women and minorities. The study will be open to all persons of any race or gender who are:

 *18 to 35 years old

 BMI > 22 kg / m2

 Self report smoking > 10 cigarettes each day

 Have access to a telephone and the internet

 Demonstrate ability to access a specific web site

 Demonstrate ability to receive and respond to email

 Willing to accept random assignment

 *Intending to be available for a 24 month intervention

 *At risk for weight gain (e.g. plan to quit smoking)

['Smoking Cessation', 'Smoking Cessation plus Weight Loss']

Smoking Cessation
Smoking Cessation plus Weight Loss


Impacts of Intraperitoneal Pressure and CO2 Gas on Surgical Peritoneal Environment

Summary: Use lay language.~The primary purpose is to compare the impacts of intraperitoneal pressure (8mmHg versus 12 mmHg) and CO2 gas (cool, dry CO2 gas versus warmed, humidified CO2 gas) on gene expression in peritoneal tissues during laparoscopic surgery. We hypothesize that combined use of a low Intraperitoneal pressure (8mmHg) and warmed, humidified CO2 gas during CO2 pneumoperitoneum may be better in minimizing adverse effects on surgical peritoneal environment and improving clinical outcomes compared to the standard intraperitoneal pressure (12mmHg) and standard cool, dry CO2 gas.
Inclusion criteria: inclusion criteria:

 Age 45-75 years old

 Petients undergoing laparoscopic hysterectomy with promontofixation for uterine prolapse

 Menopaused

 ASA class I or II

Exclusion criteria: :

 Absolute contraindications to laparoscopy

 Previous history of pelvic surgery, endometriosis and/or infection

 Pathological peritoneal tissue

 BMI more than 30

 Height less than 150cm

['Fisher and Paykel Humidifier (MR860AEU)']

['Laparoscopic Hysteretctomy With Promontofixation']


Rheumatoid Arthritis Patients on Adalimumab to Evaluate Its Effect on Synovitis Using Ultrasonography in an Egyptian Population

Summary: This Post-Marketing Observational Study (PMOS) was conducted to assess the effectiveness of adalimumab on reducing synovitis (inflammation of the synovial membrane, which lines movable synovial joints, such as shoulders, elbows, wrists, knees, and hips) in adult participants with Rheumatoid Arthritis (RA) in Egypt. B-mode ultrasonography data was collected from participants receiving adalimumab treatment who had not been treated with any other anti-tumor necrosis factor (anti-TNF) therapy in the past.
Inclusion criteria: inclusion criteria:

 A patient will be enrolled in this study if he/she fulfills ALL of the following criteria:

 Male or Female patients ≥ 18 years of age with diagnosis of RA

 Patient is eligible to start adalimumab therapy according to the local product label and prescription guidelines

 Patient is naïve to all biologics e.g. anti-cluster of differentiation 4 (anti-CD4) and anti-TNF treatments at the start of the study

 Patient has no history of inflammatory arthritis other than rheumatoid arthritis

 Patient has no history of lymphoma or leukemia or other malignancies

 Has negative result of tuberculosis (TB) screening test or is receiving TB prophylaxis as per local guidelines, Provided written Authorization to the investigator to use and/or disclose personal and/or health data, or Informed Consent if requested by the Local Regulations

Exclusion criteria: :

 Patients that are not diagnosed with rheumatoid arthritis as judged by the American College of Rheumatology criteria

 Patient is currently diagnosed with any condition other than rheumatoid arthritis that may affect radiography progression

 Susceptibility to infections including TB, as judged by the investigator

 Patient is carrier of Hepatitis B virus

 Patient is a pregnant or lactating female at the time of screening


Effect of Nasal Continuous Positive Airway Pressure (CPAP) Blood Pressure and Vascular Endothelial Growth Factor in Obstructive Sleep Apnea Syndrome

Summary: Sleep-disordered breathing (SDB) briefly means cessation of breathing during sleep at least 5 times per hour. SDB is a common disorder affecting 9 to 24% of the middle-aged and overall 4% of the middle-aged male population suffers from the Obstructive sleep apnea syndrome (OSA) i.e. Sleep-disordered breathing (SDB) with associated daytime sleepiness. Several major epidemiological studies have shown that SDB is not only an independent risk factor for hypertension but it is also strongly associated with heart failure and stroke. The mechanism for the linkage between SDB and cardiovascular consequences is not fully determined. Vascular endothelial growth factor (VEGF) is a soluble 34-46 kD angiogenic heparin-binding glycoprotein. This cytokine regulates multiple endothelial cell functions including vascular permeability and vascular tone and some data suggest that it may contribute to the atherosclerotic process. Recent studies have shown increased plasma and serum concentrations of Vascular endothelial growth factor (VEGF) in patients with OSA and there were correlations between VEGF concentrations and the severity of OSA, as indexed by the minimum oxygen saturation level and the frequency of the upper airway obstruction per hour of sleep. A recent non-randomized study with a small sample size has shown a significant decrease in Vascular endothelial growth factor (VEGF) concentrations in patients in whom nocturnal hypoxia improved after 1 year of nasal continuous positive airway pressure (CPAP) therapy.~Despite robust evidence showing improvement of symptoms, cognitive function and quality of life in obstructive sleep apnea (OSA) patients treated with nasal CPAP, there are nevertheless conflicting data whether Continuous positive airway pressure (CPAP) can reduce daytime blood pressure (BP) in patients with OSA. Two randomized placebo controlled studies have shown reduction of 24-hr systolic and diastolic blood pressure (BP) in obstructive sleep apnea (OSA) patients after 1 month of nasal continuous positive airway pressure (CPAP) therapy while other investigators have shown no such benefit.~This randomized, sham-placebo controlled study aims to assess 1) the effect of nasal continuous positive airway pressure (CPAP) over a period of 3 months on 24 hr blood pressure (BP); and 2) whether any change in BP and plasma Vascular endothelial growth factor (VEGF) is related to the baseline severity of obstructive sleep apnea (OSA) and continuous positive airway pressure (CPAP) compliance.
Inclusion criteria: inclusion criteria:

 Age 20 to 80 yrs

 Apnea hypopnea index (AHI) > 10/hr on Polysomnograph (PSG) with symptoms of obstructive sleep apnea (OSA) as described previously

 Epworth Sleepiness Scale (ESS) >10

 Patients with hypertension will still be eligible to enter and continue the study as long as there is no alteration of anti-hypertensive medications during the study period

Exclusion criteria: :

 Patients having problems staying awake during driving, shift work

 Recent myocardial infarction

 Unstable angina

 Underlying malignancy

['Continuous positive airway pressure (CPAP)', 'Sham Continuous positive airway pressure (CPAP)']


Evaluation of Integra® Artificial Dermis for the Treatment of Leg Ulcers

Summary: The aim of this prospective study is to assess the utility of treatment of leg ulcers using a skin substitute, Integra®, assessing the quality of wound skin healing and transcutaneous oxygen pressure in the distal region of the wound.~This is a multi-centre study on 60 patients who have a lower limb ulcer.
Inclusion criteria: inclusion criteria:

 patient with a lower limb ulcer, regardless of origin (arterial, venous or mixed, diabetic foot ulcer) present for more than 6 months or large in size (> 10 cm²)

 patients in whom the surgeon has recommended that an Integra® matrix be implanted (even if the patient is not taking part in the study) before the dermo-epidermal graft to obtain a richly vascularised neodermis.

 not eligible for skin flap surgery,

 the patient or patient's representative has agreed to sign the information letter before any investigation required by the research.

Exclusion criteria: :

 circumferential wound,

 wound infection

 immunosuppressed patient,

 known allergy to bovine collagen, bovine glycosaminoglycans or silicone,

 patients under legal guardianship,

 pregnant women

 patients whose health would compromise follow-up for at least 18 months,

 patients whose mental health would compromise completion of the self-evaluation questionnaires.

 wound located in an area not visible by the patient (as no self-assessment would be possible).


Do Pharyngeal Packs During Orthognathic Surgery Reduce Postoperative Nausea and Vomiting

Summary: The purpose of this study is to determine whether pharyngeal packs can reduce nausea and vomiting in patients undergoing orthognathic surgery.
Inclusion criteria: inclusion criteria:

 undergoing elective orthognathic surgery

 age 18-50 year olds

 signed informed consent

Exclusion criteria: :

 pregnant women

 past history of oesophageal surgery, oesophageal varices or stricture,

 patients who have received antiemetic medication in the 24 hours before surgery

 emergency surgery

 prior history of motion sickness and/or PONV, vertigo or migraine headaches


Optimizing Vitamin D Nutrition in Healthy Adults

Summary: The purpose of this study is to determine the average dosage of oral vitamin D supplementation to maintain optimal vitamin D levels in the body and to see if there are differences in the response to oral vitamin D supplementation between African-American and Caucasian subjects.
Inclusion criteria: inclusion criteria:

 Healthy African-American and Caucasian adults aged 18-65 years.

Exclusion criteria: :

 Subjects who are not either African-American or Caucasian. The investigators plan to examine racial differences in response to oral vitamin D dosing and, therefore, have chosen the most affected (African-American) and the least affected (Caucasian) racial groups. Including other racial/ethnic groups may confound the results unless they are studied as separate groups.

 Any chronic medical illness including diabetes mellitus, history of myocardial infarction or heart failure, malignancy, hypertension (systolic blood pressure [SBP] > 140), obesity (body mass index [BMI] > 35 kg/m2), history of anemia, leukemia, or other hematologic abnormalities, lupus, rheumatoid arthritis, or other rheumatologic disease, or kidney disease of any kind as determined by history and physical examination.

 Subjects with osteoporosis or taking medications for osteoporosis such as bisphosphonates.

 Pregnancy.

 Use of medication that influences bone metabolism (i.e. anticonvulsant medications, steroids, diuretics).

 Significant deviation from normal in either history, physical examination, or laboratory tests, as evaluated by the primary investigator.

 Patients with a history of hypercalciuria, hypercalcemia, nephrolithiasis, and active sarcoidosis.

 Participation in another investigational trial in the past 30 days prior to the screening evaluation.

 Unexplained weight loss of > 15% during the previous year or history of anorexia nervosa.

 Medications that interfere with vitamin D metabolism. Oral contraceptive use will be allowed, but will be appropriately documented.

 Smokers greater than 1 pack per day.

 Patients reporting alcohol intake greater than 2 drinks daily.

 Subjects with baseline 25-OHD level greater than 80 nmol/L or less than 20 nmol/L.


Prospective Evaluation of the Use of Intralesional Cryotherapy for Treatment of Keloid and Hypertrophic Scars

Summary: This prospective evaluation studies the effectiveness of IL cryotherapy in treating keloids and hypertrophic scars in a large population of mixed Fitzpatrick skin types.
Inclusion criteria: inclusion criteria:

 Keloids, defined as excessive scar tissue raised above skin level and proliferating beyond the confines of the original lesion

 Hypertrophic scars1 older than 12 months and insensitive to other treatments. Keloids were distinguished from hypertrophic scars based on the clinical judgment of experienced plastic surgeons and on the age of the scar (>1yr)

 A period between previous treatment and IL cryotherapy covered a minimum of 12 weeks

 Patients with all Fitzpatrick17 skin types

 Patients older than 10 years of age

Exclusion criteria: :

 pregnancy

 diabetes mellitus


PET Scan in Patients With Lung and Esophageal Cancers That May Be Removed by Surgery

Summary: RATIONALE: Imaging procedures, such as fludeoxyglucose F 18 positron emission tomography (PET) scans, may improve the ability to detect lung and esophageal cancer or their recurrence.~PURPOSE: Phase II/III trial to study the effectiveness of fludeoxyglucose F 18 PET scans in measuring response to induction chemotherapy in patients with esophageal and lung cancer that may be removed by surgery.
Inclusion criteria: DISEASE CHARACTERISTICS: Histologically confirmed esophageal or non-small cell lung carcinoma Esophageal cancer: Biopsy proven esophageal carcinoma considered acceptable for curative esophageal resection Lung cancer: Stages IA-IIIB, T(any)N(any)M0 disease without pleural effusion, which constitutes locally advanced lung cancer Must be candidates for induction chemotherapy followed by surgical resection

 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 160,000/mm3 Hepatic: Bilirubin no greater than 1.0 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance greater than 65 mL/min Other: Not pregnant Adequate contraception required of all fertile female patients

 PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: No prior surgical mediastinal staging such as prior mediastinoscopy or Chamberlain procedures See Disease Characteristics
Exclusion criteria:

['positron emission tomography', 'fludeoxyglucose F 18']

positron emission tomography
fludeoxyglucose F 18