Diuretic Efficacy of Dexamethasone in Heart Failure

Summary: The purpose of this study is to determine whether glucocorticoids have potent diuretic effects in patients with congestive heart failure.
Inclusion criteria: inclusion criteria:

 Congestive heart failure patients due to any cause

 Patients with normal cortical function

 Congestive heart failure patients who are on diuretic therapy

 Clinically stable and body weight maintained the same for at least 3 days without signs of fluid retention

Exclusion criteria: :

 Patient refusal

 Signs of infection

:

 Patient refusal

 Signs of infection


Understanding Pediatric Chest Pain and Other Symptoms

Summary: The causes of pediatric pain are often not the same for every child. Most children who visit a cardiology specialist with complaints of chest or other somatic pain have no known medical diagnosis to explain their symptoms. These children and their families often leave with no explanation for the child's distress.~This early study will ask parents and children specific questions related to the stress in their lives, their emotional well-being and the children's physical functioning. The investigators want children who experience chest and other somatic pain, and those who do not, to be in their study so that they can look at both groups.~The investigators hope to use these answers to better inform cardiologists who often work with children with non-cardiac pain and, in turn, help them to better serve their patients. Ultimately, the investigators hope that the answers they get will provide answers to these families. They also hope to use the results of this study to put together a short screener for the cardiologist to give to pediatric patients with complaints of chest or other somatic pain to help the cardiologists better understand their patients' symptoms.
Inclusion criteria: inclusion criteria:

 8-18 years of age

 Pediatric patients with referrals for innocent heart murmurs

 Pediatric patients experiencing chest pain

 English speaking

Exclusion criteria: :

 Non English speaking patients


Left vs. Right Radial Approach for Routine Catheterization of Heart Transplant Patients

Summary: Orthotopic heart transplantation is a well established therapeutic measure for end stage heart failure, leading to significant improvements in survival and quality of life. In the routine clinical practice, orthotopic heart transplantation patients receive periodic cardiac catheterization for early detection of allograft vascular disease.~The coronary angiography of these patients is characterized for several technical difficulties, generally related to the presence of the aortotomy with anomalous implantation of the coronary ostia and to the orthotopic position of the allograft. For these reasons, trans femoral approach is usually preferred. In the last two decades, trans radial approach for coronary angiography emerged to be effective, safe and able to improve patient comfort. However, there is no universal consensus on the optimal choice of radial access from either the left or the right artery. Currently, this choice is largely dependent on the operator's preference. The trans right radial approach is generally preferred in routine clinical practice mainly due to its easier catheter manipulation for the operators from patient's right side, and the current design of radial compression devices for the right wrist in medical market. As such, a major barrier to prevent the wide adoption of the left radial access lies in some difficulty to reach the left wrist leaning over the patient, particularly for shorter operators or in obese patients. However, a great deal of attention has been recently directed toward the trans left radial access, as it has an important anatomical advantage due to the vascular anatomy of epiaortic vessels with a straighter route to the left coronary ostium, which could also reduce the risk of cerebrovascular complications.~However, no data are available about the performance of trans left radial or trans-right radial approach in coronary angiography orthotopic heart transplantation patients. However, in this particular setting of patients, the left radial approach might reduce the technical difficulties related to the anatomical variations.~In this single centre, prospective, randomized study, we sought to compare trans right radial versus trans left radial approach in terms of amount of contrast medium, radiation exposure, number of catheters used, cross over to the other access site rate and local and systemic complications in orthotopic heart transplantation patients.
Inclusion criteria: inclusion criteria: eligible transplanted patients scheduled for a routine coronary angiography with age >18 years old.

Exclusion criteria: :

 chronic renal insufficiency (creatinine >2.0 mg/dl) with the potential necessity of using the radial artery as a native fistula will be considered one of the

['devices used in the coronary angiography']


Impact of Visceral Osteopathic Treatment on Meconium Evacuation in Preterm Infants

Summary: Timing of the first and last meconium stool is critical for oral feeding tolerance and proper gastrointestinal function. The time until premature infants pass their first meconium ranges from 1 hour to 27 days (median: 43 hours). Obstruction of the gastrointestinal tract by tenacious, sticky meconium frequently leads to gastric residuals, a distended abdomen and delayed food passage Recent data support the concept that complete rapid evacuation of meconium plays a key role in feeding tolerance . If duration to full enteral feedings is extended, the probability to acquire infections due to intravenous access for parenteral nutrition increases and hospital stay of the infant prolongates. Previously two prospective trials focusing on the problem of delayed meconium evacuation in preterm with different therapeutic pharmacological approaches were published by our group. None of the applied therapies appeared to be effective or had a beneficial effect- quite the contrary one agent (Gastrografin) was supposed to have severe negative side effects. Therefore we were looking for an alternative, non-invasive, holistic solution for the problem of delayed meconium excretion. Osteopathic treatment with the emphasis on the relationship of the structural and functional integrity of the body and with its variety of therapeutic manual techniques seemed to be remedy. Treating the abdomen of premature infants with visceral osteopathic techniques might be more effective to mobilize meconium from small bowel and deep parts of the colon. Therefore we hypothesized that repeated visceral osteopathic treatment accelerates meconium evacuation in premature infants, and thereby enhances feeding tolerance in this population.
Inclusion criteria: inclusion criteria:

 premature infants with a birthweight 1500 gram

Exclusion criteria: :

 major congenital malformations

 known gastrointestinal abnormalities


Echocardiography Management for Patients Requiring Care for Non-Cardiac Surgery

Summary: The growing population of University of Nebraska Medical Center patients with heart failure combined with the increasing number of surgical procedures performed each year supports the need for a critical analysis of how to most appropriately manage these patients during the perioperative period, especially for non-cardiac surgery. Echo-guided hemodynamic management (EGHEM) is the use of echocardiography data to normalize and/or optimize in real-time, cardiac output and ventricular filling pressures in the perioperative period for non-cardiac surgical cases. The purpose of this study is to test the hypothesis that EGHEM compared to standard management practices will result in a reduced length of hospital stay in the noncardiac surgery population. The primary goal of health care providers for patients requiring anesthetic care, perioperative care, or critical care is ensuring the adequacy of the patient's circulatory function by optimizing cardiac output and ventricular filling pressure. Currently, the use of the ECG monitor and systemic blood pressure are the standard of care for assessing circulatory function. However, those data cannot provide accurate information on cardiac output and ventricular filling pressure for patients with cardiovascular risk factors and/or comorbidities. As a result, managing the hemodynamic parameters of these patients, as well as their intravenous fluid needs and resuscitation strategy, we hypothesize that using traditional approaches may lead to significant volume overload and post-operative cardiovascular complications and morbidity. In this study we propose an EGHEM strategy that incorporates standard echocardiography generated data points in addition to the systemic blood pressure and ECG signal to assess, manage, modify and optimize patient cardiac preload, afterload, heart rate and contractility in the perioperative period. Based on our initial observations and preliminary data using the EGHEM approach, we hypothesize that we can demonstrate a significant decrease in hospital length of stay and an overall decrease in perioperative morbidity at 30 days in the non-cardiac surgery population using EGHEM compared to standard practices. In this proposal we have designed a single center, prospective, randomized clinical trial to test our hypothesis.
Inclusion criteria: inclusion criteria:

 Age ≥ 65 years

 Hypertension (HTN)

 Diabetes

 Obesity (body mass index [BMI] >35)

 Renal insufficiency

 Tobacco usage

 Hypercholesterolemia

 Sleep apnea/heavy snoring at night

 Clinical diagnosis of CHF as defined by:

 Dyspnea on exertion

 Paroxysmal nocturnal dyspnea

 Orthopnea

 Elevated jugular venous pressure

 Pulmonary rales

 Third heart sound

 Cardiomegaly or pulmonary edema on chest x-ray

 Peripheral edema

 Hepatomegaly

 Pleural effusion

 Palpitations/irregular heart beats

 Chest pain at rest and or exercise

 Murmur on examination

 Known coronary artery disease (CAD)/stents/coronary artery bypass graft (CABG)

 Known valvular disease

 Known stroke or transient ischemic attacks (TIA)

Exclusion criteria: :

 Patients expected to say in the hospital for less than 24 hours.

 Inability of undergo TEE and TTE

 Clinical evidence or suspicion of elevated intracranial pressure.

 Preoperative shock or systemic sepsis

 Emergency Operation

 ASA Class V

 Inability of give informed consent

 Participation in another clinical trial

 Prisoner

['Transthoracic Echocardiogram (TTE)/Transesophageal Echocardiogram (TEE)']


Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer

Summary: This is prospective cohort study in pregnant women who present with signs and symptoms of possible deep vein thrombosis (DVT). All patients will have the same method of assessment of their DVT symptoms (the LEFt clinical decision rule will be applied and D-dimer test will be done) to determine if a compression ultrasound is required. All patients will be followed for a period of 3 months.
Inclusion criteria: inclusion criteria:

 Unselected pregnant women (as self-reported by patient and/or previously documented positive beta hCG on urine or serum pregnancy tests) with

 Suspected acute symptomatic deep vein thrombosis, defined as:

 New leg swelling or edema with onset in the last month or,

 New leg pain (buttock, groin, thigh or calf) with onset in the last month.

Exclusion criteria: :

 Below the age of legal consent in jurisdiction of residence (18 years old for Quebec and 16 years old for rest of Canada)

 Baseline imaging (imaging done after a minimum of 3 months of treatment for prior proximal DVT) not available if suspected recurrence in the same leg as prior

 Unable or unwilling to provide informed consent

 Concomitant symptoms of suspected pulmonary embolism (chest pain or shortness of breath or syncope/pre-syncope or unexplained tachycardia)

 Therapeutic anticoagulant more than 48 hours.


Molecular, Cytological Features and Genetic Susceptibility of COPD Attributable to Different Environmental Exposures

Summary: The objective of this study is to investigate molecular, cytological and genetic features of occupational chronic obstructive pulmonary disease (COPD) in conditions of different occupational exposures. In order to achieve this goal serum pro-inflammatory cytokines and standard inflammation markers level, hemostasis, cytological analysis of bronchoalveolar lavage and associations of single nucleotide polymorphisms (SNPs) rs1800470 transforming growing factor β1 (TGF β1) gene, rs1828591 hedgehog interacting protein (HHIP) gene, rs4129267 interleukin 6 receptor (IL-6R) gene, rs1051730 nicotinic acetylcholine receptor 3 (CHRNA3) gene with COPD in subjects exposed to silica dust and in those exposed to polycyclic aromatic hydrocarbons exhaust will be investigated. The relationship between genotype and phenotype characteristics, such as an inflammation activity, assessed by C-reactive protein (hsCRP) and tumor necrosis factor-α (TNF α) serum concentration, in different occupational COPD groups will be studied. The hypothesis is that the mechanisms underlying disease development and progression are different due to environmental risk factor that reflex in differs in disease attributes - molecular biomarkers, cytology results and genetic susceptibility between COPD due to dust, COPD due to chemicals and COPD in smokers therefore COPD can be subdivided into ecological phenotypes according to environmental risk factor.
Inclusion criteria: inclusion criteria:

 Post- bronchodilator forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) ratio less than 0.7

 Stable phase of COPD

 History of exposure to respirable silica dust, nonsmokers with absence of passive exposure to tobacco smoke or history of exposure to polycyclic aromatic hydrocarbons exhaust, nonsmokers with absence of passive exposure to tobacco smoke or current tobacco smokers without history of occupational exposure

 COPD risk factor exposure (occupational or tobacco smoke) duration not less than 12 months

 Male

 Caucasian

 Age of 40 - 75 years old

 Control group - healthy people

Exclusion criteria: :

 history of biomass smoke exposure

 age less than 40 and above 75 years old

 current COPD exacerbation

 concomitant asthma

 tuberculosis and other pulmonary diseases

 allergic and autoimmune disorders

 active infections

 immunodeficiency, including HIV infection

 parasitological diseases

 malignancies

 lack of informed consent

['exposure to respirable silica dust', 'exposure to polycyclic aromatic hydrocarbons exhaust']

['Chronic Obstructive Pulmonary Disease']


Innohep® in Elderly Patients With Impaired Renal Function Treated for Acute Deep Vein Thrombosis

Summary: The objective of the study is to compare the safety of innohep® and Unfractionated Heparin (UFH) in terms of clinically relevant bleedings in elderly patients with impaired renal function for initial treatment of acute Deep Venous Thrombosis (DVT).~The primary response criterion is the percentage of patients with clinically relevant bleeding events prior to day 90 +/- 5.
Inclusion criteria: inclusion criteria:

 Patients with a symptomatic and objectively confirmed Venous Thromboembolism (VTE) (lower limb deep venous thrombosis (DVT) or pulmonary embolus (PE)) with mandatory presences of objectively confirmed and treatment requiring DVT, i.e. symptomatic and objectively confirmed distal DVT or objectively confirmed, symptomatic or asymptomatic proximal DVT (confirmation of DVT should be performed by ultrasonography or venography within 48 hous prior to randomisation)

 Patients with an indication for DVT treatment with SC Low Molecular Weight Heparin (LMWH) or Unfractionated Heparin (UFH) followed by Oral Anticoagulant (OAC) for at least 90 days

 Hospitalized patients who, during SC anticoagulant treatment, will be followed, as specified in the protocol, on a daily basis either in the hospital or in an out-patient setting

 Patients at or above 75 years with a creatinine clearance less than or equal to 60 mL/min calculated according to the Cockcroft-Gault formula

 Patients at or above 70 years with a creatinine clearance less than or equal to 30 mL/min calculated according to the Cockcroft-Gault formula

Exclusion criteria: :

 Patients receiving high dose (i.e. equivalent to a dose recommended for treatment of DVT) of UFH or LMWH or thrombolytic agents within the last 4 weeks except for UFH/LMWH during the last 36 hours prior to randomisation

 Patients on oral anticoagulant treatment (vitamin K-antagonists) at or within last 1 week prior to randomisation

 Patients with a symptomatic venous thromboembolism (VTE) requiring thrombolytic therapy or invasive intervention

 End stage renal disease patients requiring dialysis

 Surgery within 2 weeks prior to randomisation or planned surgery, epidural anaesthesia and/or spinal anaesthesia during the SC anticoagulant treatment period

 Planned use of acetylsalicylic acid in doses above 300 mg/day, NSAID or Dextran 40 at randomisation and during the SC anticoagulant treatment period

 Patients with a current overt bleeding or known haemorrhage condition (e.g. active G.I. ulcer)

 Patients with a platelet count < 100 x 10 9/L

 Patients with a known history of heparin-induced thrombocytopenia

 Patients with known severe hepatic insufficiency manifested as international normalized ratio (INR) greater than or equal to 1.5

 Patients with uncontrolled severe hypertension i.e. a systolic blood pressure > 220 mm Hg or diastolic blood pressure > 120 mm Hg during at least 2 measurements within 24 hours prior to randomisation

 Patients with ischaemic stroke at or within last 1 week prior to randomisation

 Patients with a known haemorrhagic stroke within 3 months prior to randomisation

 Patients with known bacterial endocarditis within 3 months prior to randomisation


Probiotics for Prevention of Ventilator-Associated Pneumonia (VAP)

Summary: Hospitalized patients with ventilator are randomized to receive fermented dairy product containing L. casei shirota or nothing. The main outcome is development of ventilator-associated pneumonia (VAP)
Inclusion criteria: inclusion criteria:

 Patient age ≥ 18-year who received ventilator and agreed to participate by signing informed consent form

Exclusion criteria: :

 Immunocompromised host (e.g. HIV infection, On immunosupressive agents, ANC ≤ 500 cell/ml), Pregnancy, History of congenital heart disease, rheumatic fever, previously infective endocarditis, prosthetic valve, Contraindication for enteral feeding, History of milk or milk-product allergy


Rituximab in Systemic Sclerosis

Summary: The purpose of this study is to determine whether rituximab is effective in the treatment of articular symptoms that occur in systemic sclerosis related polyarthritis
Inclusion criteria: inclusion criteria:

 Systemic sclerosis fulfilling ACR or LeRoy's criteria

 Active polyarthritis defined by > 6/53 tender joints and > 4/53 swollen joints

 Ongoing first line therapy by prednisone (max 10 mg/d) and DMARDS (methotrexate, leflunomide, azathioprine or mycophenolate)

 Birth control if applicable

Exclusion criteria: :

 Overlap syndrome defined by clinical symptoms and positive specific auto-antibodies (anti-CCP, anti-SSA, anti-DNA DNA anti-Sm) (Rheumatoid factors and anti-RNP are not


Primary Prevention of Major Adverse Cardiac Events (MACE) With Standard and Intensive Statin Treatment in Patients With Diabetes: Survival and Cardiovascular Event Assessments

Summary: The study is being conducted to compare the effect of standard treatment (target LDL-C level: <120 mg/dL (JASGL 2007 target level)) and intensive treatment (target LDL-C level: <70 mg/dL) in the prevention of major adverse cardiac events (MACE) in hypercholesterolemia patients with concomitant type 2 diabetes and hypertension.
Inclusion criteria: inclusion criteria:

 Patients meeting the following inclusion criteria will be included in the study:

 Patients giving voluntary written consent to participate in the study

 Male or female patients 50 years of age or older (at informed consent)

 Hypercholesterolemia patients (Untreated patients: LDL-C level ≥140 mg/dL; treated patients: LDL-C level ≥120 mg/dL)

 Type 2 diabetes patients (HbA1c level ≥6.1% (JDS criteria), with or without history of drug therapy)

 Hypertension patients (SBP ≥130 mmHg or DBP ≥80 mmHg, with or without history of drug therapy)

 Patients with two or more of the following risk factors

 Male

 65 years of age or older

 Smoker

 L/H ratio: ≥3.0 •HbA1c level: ≥8.0%

 Left ventricular hypertrophy

 First- or second-degree family history of MACE

 Microalbuminuria (quantitative testing: ≥30 mg/dL), proteinuria (qualitative testing: + or higher) or eGFR (<60 mL/min/1.73 m2)

Exclusion criteria: :

 Patients meeting the following criteria will be excluded from the study:

 Patients receiving rosuvastatin, pitavastatin, or atorvastatin therapy within one month prior to informed consent

 Patients judged to have familial hypercholesterolemia

 Patients with a serum triglyceride level of ≥400 mg/dL

 Patients with a history of myocardial infarction

 Patients with a history of coronary revascularization (PCI or CABG)

 Patients with a history of treatment of unstable angina

 Patients with a history of cerebrovascular accident (excluding asymptomatic lacunar infarction)

 Heart failure patients

 Patients with a history of hypersensitivity to statins

 Patients with a history of drug-induced myopathy

 Patients with poorly controlled arrhythmia

 Patients with severe liver or kidney disease

 Patients with serious concurrent disease, such as malignancy, or patients with severely limited lifespan

 Patients who are or may be pregnant

 Patients judged by the investigators to be ineligible for participation in the study for any other reason

['Hypercholesterolemia', 'Type 2 Diabetes', 'Hypertension']

Hypercholesterolemia
Type 2 Diabetes
Hypertension


SERETIDE 50/500mcg Versus Tiotropium Bromide On Exacerbation Rates In Severe Chronic Obstructive Pulmonary Disease

Summary: This is a comparator study to assess the relative efficacy of the combination product fluticasone propionate/salmeterol 50/500 and tiotropium bromide on the rate of exacerbations of chronic obstructive pulmonary disease (COPD) over a two year study interval.
Inclusion criteria: inclusion criteria:

 Established clinical history of moderate to severe COPD.

 Post bronchodilator FEV1 of < 50% of predicted normal.

 FEV1 / FVC ratio <70%.

 Reversibility to 400mcg albuterol of less or equal to 10 predicted at Visit 1.

 Free from exacerbation in the 6 weeks prior to screening.

 Current or former smoker with a smoking history of = 10 pack-years and has a history of COPD exacerbations.

Exclusion criteria: :

 Current asthma, eczema, atopic dermatitis and/or allergic rhinitis.

 Has a known respiratory disorder other than COPD (e.g. lung cancer, sarcoidosis, tuberculosis or lung fibrosis).

 Has narrow-angle glaucoma, prostatic hyperplasia or obstruction of the neck of the bladder that in the opinion of the investigator should prevent the subject from entering the study.

 Has undergone lung transplantation and/or lung volume reduction.

 Female who is a nursing mother.

 Requires regular (daily) long-term oxygen therapy (LTOT).

 Is receiving beta-blockers (except eye drops).

 Has a serious, uncontrolled disease likely to interfere with the study.

 Has received any other investigational drugs within the 4 weeks prior to Visit 1.

 Has, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.

 Has a known or suspected hypersensitivity to beta2-agonists, inhaled corticosteroids, anticholinergic agents or any components of the formulations (e.g. lactose or milk protein).

['Tiotropium bromide 18mcg', 'Fluticasone propionate/ salmeterol combination 50/500mcg']

['Pulmonary Disease, Chronic Obstructive']


Safety of Sublingual dmLT for ETEC

Summary: A Phase 1 dose escalating study of ETEC candidate vaccine to determine safety and immunogenicity of a multi-dose regimen in healthy adult volunteers. The study will be conducted at Cincinnati Children's Hospital Medical Center (CCHMC). The primary objectives assess the safety and tolerability of dmLT vaccine when administered in three doses sublingually over a range of dosages in healthy adult subjects. The secondary objectives assess long-term safety follow-up from immunization through Month 7 post vaccination, following three SL doses of dmLT vaccine over a range of dosages and comparing with three doses of a comparable dosage of oral vaccine. The study subject population is 52 healthy adult male and female subjects, ages 18 to 45. Subject participation duration is approximately 8 months with study duration of approximately 1.5-2 years, including 6-7 months of follow-up.
Inclusion criteria: inclusion criteria:

 - Male or female ages 18-45, inclusive. - Provide written informed consent before initiation of any study procedures. - General good health, without (a) significant medical illness, (b) clinically significant physical examination findings, including vitals, as determined by the PI, and (c) screening laboratory values outside the site's normal limits. - Within 46 days of vaccination, have normal screening laboratories, per Appendix B for white blood cells (WBCs), hemoglobin (Hgb), platelets, absolute neutrophil count (ANC), sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST). - Have normal screening laboratories for urine protein Trace protein is acceptable. - HgbA1C <6.5% at screening. - Demonstrate comprehension of the protocol procedures and knowledge of study by passing a written examination (passing grade is at least 70 percent). - Agrees to complete all study visits and procedures. - Female subjects must be of non-childbearing potential (as defined as surgically sterile or postmenopausal for more than 1 year), or if of childbearing potential, must be using an effective method of birth control (e.g., use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], cervical sponges, diaphragms, condoms with spermicidal agents must have a vasectomized partner) within 2 months of vaccination, or practice abstinence and must agree to continue such precautions during the study and for 30 days after the Day 29 study visit. Male subjects must agree not to father a child for 30 days after the Day 29 study visit. A woman is eligible if she is monogamous with a vasectomized male. - Agrees not to participate in another clinical trial during the study period. - Agrees not to donate blood to a blood bank for 12 months after receiving the vaccine. - Potential subjects must be willing to adhere to the following prohibitions and restrictions during the course of the study to be eligible for participation: - Strenuous exercise (e.g., long distance running > 5km/day, weight lifting, or any physical activity to which the subject is not accustomed) is to be avoided during the overnight stay and for at least 72 hours prior to each study drug administration (and the Follow-up visit). - Subjects should not have donated blood in the 8 weeks prior to study entry.

Exclusion criteria: :

 - Women who are pregnant or lactating or have a positive serum pregnancy test at screening or positive urine pregnancy test prior to vaccination. - Abnormal vital signs, defined as: -- Hypertension (systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg) at rest on 2 separate days; or -- Palpated heart rate <55 or >100 beats/minute at rest on 2 separate days*; or *If heart rate between 45 and 55, subjects may be enrolled with an EKG that demonstrates normal sinus rhythm and does not document conduction disorders. --Temperature >/= 38.0 degrees C (100.4 degrees F) - Symptoms of an acute self-limited illness, including a temperature >/= 38.0 degrees C (100.4 degrees F), such as an upper respiratory infection or gastroenteritis within 7 days of administration of dmLT. - Positive hepatitis C, or HIV serology or positive hepatitis B serology not consistent with prior hepatitis B immunization. - Have a positive urine drug screen for opiates. - Subjects who are unwilling or unable to cease smoking for the duration of the overnight stay. - History of antimicrobial treatment in the 2 weeks before administration of dmLT. - Received previous experimental E. coli, LT, or cholera vaccines or live E. coli or Vibrio cholera challenges; or previous infection with cholera or diarrheagenic E. coli. - Abnormal routine bowel habits as defined by fewer than three stools per week or more than two stools per day in the past 6 months. - History of chronic gastrointestinal illness, including severe dyspepsia (mild or moderate heartburn or epigastric pain occurring no more than three times per week is permitted), or other significant gastrointestinal tract disease. - Regular use (weekly or more often) of laxatives, anti-diarrheal, anti-constipation, or antacid therapy. - History of major gastrointestinal surgery, excluding uncomplicated appendectomy or cholecystectomy. - Long-term use, defined as longer than 14 days, of oral steroids, parenteral steroids, or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. (Nasal and topical steroids are allowed). - Have a diagnosis of schizophrenia or other major psychiatric diagnosis. - Are receiving the following psychiatric drugs: aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, chlorprothixene, chlorpromazine, perphenazine, trifluopromazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate, or lithium citrate. NOTE: Subjects who are receiving a single antidepressant drug and are stable for at least 3 months before enrollment without de-compensating symptoms are allowed to be enrolled in the study. - History of receiving Ig or other blood product within the 3 months before enrollment in this study. - Traveled to ETEC-endemic areas, defined as Africa, Middle East, South Asia, or Central or South America within the past 3 years or raised in a cholera or ETEC endemic area. - Received any licensed vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) before enrollment in this study or plans to receive any licensed vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) after any study vaccination. - An acute or chronic medical condition that, in the opinion of the investigator, would render administration of dmLT unsafe or would interfere with the evaluation of responses. This includes, but is not limited to: known or suspected immunodeficiency, known chronic liver disease, significant renal disease, unstable or pr ogressive neurological disorders, history of diabetes, cancer (other than a healed skin lesion), heart disease (in the hospital for a heart attack, history of irregular heart beat or fainting caused by an irregular heartbeat), unconsciousness (other than a single brief concussion), seizures (other than with fever when subject was a child <5 years old), asthma requiring treatment with inhaler or medication in the prior 2 years, autoimmune disease or eating disorder, and transplant recipients. - Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month before enrollment in this study or expects to receive an experimental agent during the study. - History of alcohol or drug abuse in the last 5 years. - Plans to travel outside of the USA in the time between study vaccination and 28 days following the final vaccination. - Unable to spend up to 48 hours at an overnight facility following the administration of Dose 1. - Any condition that would, in the opinion of the Site Investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol. - Use of prescription or over-the-counter (OTC) medications that contain acetaminophen, aspirin, ibuprofen, and other non-steroidal anti-inflammatory drugs within 48 hours prior to receiving the investigational product. - Use of prescription acid suppression medication or OTC antacids within 72 hours of investigational product administration. - Subjects with autoimmune disorders, chronic inflammatory disorders or neurological disorders with a potential autoimmune correlation. - Subjects who planned to travel to an ETEC-endemic area, defined as Africa, Middle East, South Asia, or Central or South America, during the long-term safety follow-up period (6 months) of the study. - Known allergies to study compound. - Special populations, e.g., non-English speakers, children, illiterate or non-writing individuals, vulnerable populations. - Any abnormality of the palate.

['Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine', 'Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine']


MAgnetic Resonance Imaging in COeliac Disease

Summary: One in 100 people suffers from coeliac disease. It affects the lining of the bowel and causes many symptoms such as diarrhoea, wind, stomach pain, constipation and nausea. The only treatment so far is a strict glutenfree diet for life which reverses the bowel damage and often improves symptoms. Up to 25% of patients however may have persistent symptoms despite the gluten free diet but the reasons for this are not clear.~This research aims to help us understand how the gluten free diet works. Investigators will use medical imaging (magnetic resonance imaging or MRI) to measure the volumes of fluid in the small bowel, the size of the large bowel and the time it takes for foods to go through the entire bowel in patients who have just been diagnosed with coeliac disease by their hospital doctor. Investigators will also carry out a breath test and collect a stool sample for basic analysis of the stool bacteria.~Investigators will also collect questionnaires about their feelings and their bowel habits and will try to see how the MRI measurements relate to the patients' symptoms. Investigators will observe how all these measures change after one year of the gluten free diet that doctors will have prescribed as part of the coeliac patients' standard care. As such there is no dietary intervention in this study, investigators will simply study changes in the patients due to their standard treatment. Investigators will also look at a matched group of healthy volunteers to gather a likely reference range of the measurements. This research will be carried out in Nottingham with the help of the specialist coeliac clinics and it will last 3 years. There is a dedicated Coeliac Patient Public Involvement group who have helped plan this study.
Inclusion criteria: Inclusion:

 Patients newly diagnosed with coeliac disease:

 Male or female

 Able to give informed consent

 Able to schedule the first MRI scan (Visit 2 of the study) within a month of having had a duodenal biopsy and not yet commenced on a gluten free diet.

 Inclusion

 Pilot study in healthy volunteers:

 Healthy volunteers (without any comorbidities)

 Able to give informed consent

 Exclusion Pilot study in patients

 Any past serious, unstable medical condition, unstable/uncontrolled diabetes mellitus, major psychiatric diagnosis

 Any reported history of gastrointestinal surgery that could affect gastrointestinal function (colectomy, small bowel resection)

 Pregnancy declared by candidate

 Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury

 Reported alcohol dependence

 Unable to stop drugs known to alter GI motility including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists during or in the 2 weeks prior to the test. The following medications can be permitted during the course of the study, as long as they have been used at a constant dosage and were commenced at least 1 month prior to the start of the study: birth control pill, or depot intramuscular contraceptive preparation, oestrogen-progesterone replacement therapy, L-thyroxine, lowdose antidepressants (up to 25 mg day) of amitriptyline, nortriptyline, or selective serotonin reuptake inhibitor), or antihypertensive in the diuretic, angiotensin converting enzyme inhibitor or angiotensin II inhibitor classes. Antibiotic or probiotic treatment in the past 4 weeks

 Inability to lie flat or exceed scanner limits of weight <120kg

 Poor understanding of English language

 Participation of any medical trials for the past 3 months

 Judgement by the PI that the candidate who will be unable to comply with the full study protocol e.g. severe COPD

 Noncompliance to gluten free diet after first, untreated MRI.

 Exclusion

 Healthy volunteers:

 Serology positive test for coeliac disease markers

 Any reported history of gastrointestinal surgery that could affect gastrointestinal function (colectomy, small bowel resection)

 Presence of an intestinal stoma

 Pregnancy declared by candidate

 Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury

 Reported alcohol dependence

 Unable to stop drugs known to alter GI motility including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists during or in the 2 weeks prior to the test. The following medications can be permitted during the course of the study, as long as they have been used at a constant dosage and were commenced at least 1 month prior to the start of the study: birth control pill, or depot intramuscular contraceptive preparation, oestrogen-progesterone replacement therapy, L-thyroxine, lowdose antidepressants (up to 25 mg day1 of amitriptyline, nortriptyline, or selective serotonin reuptake inhibitor), or antihypertensive in the diuretic, angiotensin converting enzyme inhibitor or angiotensin II inhibitor classes.

 Proton Pump Inhibitor (PPI), antibiotic or probiotic treatment in the past 12 weeks

 Inability to lie flat or exceed scanner limits of weight <120kg

 Poor understanding of English language

 Participation of any medical trials for the past 3 months
Exclusion criteria:

['Celiac Disease', 'Coeliac Disease', 'Celiac Sprue', 'Gluten Enteropathy']

Celiac Disease
Coeliac Disease
Celiac Sprue
Gluten Enteropathy


Effect Of Itopride On Gastric Emptying And Accommodation In Patients With Functional Dyspepsia

Summary: Pathogenesis of functional dyspepsia is poorly understood. Gastrointestinal motor abnormalities, Helicobacter pylori infection, impaired gastric accommodation to a meal, hypersensitivity of the afferent nerves of the gut, psychological disturbances and central nervous system dysfunction have been proposed.~Pharmacological treatments for patients with functional dyspepsia remain unsatisfactory. Only small benefits relative to placebo have been found with histamine H2 receptor antagonists, proton pump inhibitor and Helicobacter pylori eradication.~Itopride is a dopamine antagonist with acetylcholinesterase inhibitory actions. This agent is currently indicated for patients with various upper GI symptoms.~This study is aimed to evaluate the effect of Itopride on gastric emptying(by 13-C Octanoic acid breath Test), accommodation (by Gastric Scintigraphy SPECT and slow nutrient drinking test)and symptoms in FD patients
Inclusion criteria: inclusion criteria:

 All adult male or non-pregnant female patients who are diagnosed as functional dyspepsia and fulfilling Rome III criteria (1) will be considered

 Patients should be negative for H. pylori on gastric biopsy and Urea Breath Test.

 duodenal biopsy in these patients should be negative for giardiasis or celiac disease or any other established organic pathology

 A normal upper abdominal ultrasound

 Willing to participate and give consent for participation in the study.

Exclusion criteria: :

 Age <18 years

 Helicobacter Pylori positive on gastric biopsy and / or UBT.

 Taking other medications that alter gastric motility like macrolide

 anti-emetics and antibiotics .

 Pregnant or breast-feeding females.

['Functional Dyspepsia', 'Gastric Emptying', 'Gastric Accommodation']

Functional Dyspepsia
Gastric Emptying
Gastric Accommodation


Letrozole Versus Clomiphene Citrate for Ovulation Induction in Women With Poly Cystic Ovary Syndrome ( PCOS )

Summary: 110 infertile women diagnosed as polycystic ovary syndrome (PCOS) at the age group of 20-35 distributed randomly :~55 women will receive letrozole 2.5mg twice daily orally from the 2nd day to the 6thday of the cycle for three successive cycles.~55 women will receive clomiphene citrate 50 mg twice daily orally from the 2nd day to the 6thday of the cycle for three successive cycles.~Patients will be subjected to:~Complete history taking:~Details about name, age~Menstrual history with determination of menarche~Amenorrhea or oligomenorrhea , Regularity of the cycle~History of endocrine disease.~History of previous operations.~Physical examination:~General examination:~With special concern to:~--Acne.~--Hirsutism .~--Weight.~--Height~--BMI was determined :~Wt. in kg ـــــــــــــــــــ =~) Height in m)2~- Abdominal examination :~for scar of previous pelvic or abdominal operations .~Pelvic examination :~vaginal examination for enlarged cystic ovaries.~ultrasound for diagnosis of pcos.~PARAMETERS:~(1) rate of ovulation (primary parameter). (2) serum progesterone level on day 21. (3) number of mature follicles produced per cycle. (4) mean endometrial thickness. (6) chemical pregnancy. (7) ongoing pregnancy
Inclusion criteria: inclusion criteria:

 Age between 20-35

 Primary or secondary infertility

 Patients diagnosed as PCOs according to Rotterdam criteria (Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group.,2003)

Exclusion criteria: :

 Any patients have any causes of infertility other than which mentioned in the inclusion criteria as:

 Hyperprolactinemia.

 Male factor of infertility.

 WHO Guidelines 2010 for Normal seminal fluid analysis :

 Volume> 1.5 ml

 ph 7.2 to 8.0

 Liquefaction time 20 to 30 min

 Sperms concentration >15 million/ml

 Total motility 40%(Progressive motility + non progressive motility)

 Progressive motility 32%

 Morphology > 4% normal forms

 Thyroid dysfunction.

 Diabetes Mellitus.

 Known or suspicious tubal factor infertility by HSG or laparoscope.

 Endometrioses or pelvic inflammatory diseases .

['Letrozole', 'Clomiphene citrate', 'hcg hormone']

Letrozole
Clomiphene citrate
hcg hormone

['Anovulation', 'Polycystic Ovary Syndrome']


Mindfulness and Acceptance Applied in Colleges Through Web-Based Guided Self-Help

Summary: College counseling centers (CCCs) are being faced with increasing demands for services to meet the treatment needs of their students, in the context of increasingly severe cases and declining resources. Innovative, cost effective solutions are needed.~The proposed project seeks to meet these needs by testing a web-based guided self-help version of Acceptance and Commitment Therapy (ACT), an evidence-based transdiagnostic therapy found to effectively treat a range of psychological problems. An ACT program would provide a means of implementing effective treatment for the range of problems in the CCC setting, while the guided self-help format would reduce counselors' workload, improving cost-effectiveness and reducing waiting lists. This would both treat students and train counselors in how to implement the ACT intervention. Three self-help lessons have been developed, as well as a counselor portal to review students' use of the program and to receive training on implementing ACT guided self-help.~The study is a pre-post, open(i.e., non-randomized) feasibility trial with 20 counselors and 60 clients from multiple CCCs throughout the country.
Inclusion criteria: inclusion criteria for Counselors:

 Currently working at a College Counseling Center

 Willingness to take the ACT guided self-help training through the counselor portal until reaching a passing criterion of 80%

 Willingness to distribute flyers about the study to five students, in an attempt to recruit 3 clients to participate in the self-help modules

Exclusion criteria:  for Counselors:

 Prior participation in this study

 inclusion criteria for Student Clients:

 Currently being treated at a College Counseling Center

 Willingness to participate in three half-hour modules as part of a web-based guided self-help program and complete pre and post assessments across a period of 4 weeks

 Referred to the study/self-help modules by counselor

 Participation will comply with targeted enrollment plans, and attention will be paid to selecting an ethnically/racially diverse group

 Student is clinically stable as per counselor judgment (e.g., not actively suicidal, psychotic, or disruptive)


Assessment of Sleep Complaints in Brain Tumor Survivors

Summary: Survivors of pediatric brain tumors are noted to have increased rates of excessive daytime sleepiness. However, very little data are available regarding the specific sleep disturbances of pediatric brain tumor survivors. Children ages 8 to 18 years of age who are at least 5 years from diagnosis and at least 2 years post treatment or observation only for a brain tumor will be targeted to assess the prevalence of sleep complaints.~The study focuses on the following objectives:~To estimate sleep disturbance in a cohort of pediatric brain tumor survivors.~Estimate the rates of parent- and self-reported excessive daytime sleepiness in pediatric brain tumors~Estimate the rates of parent-reported sleep-disordered breathing, including snoring and witnessed apneas, in pediatric brain tumor survivors~Estimate the rates of parent- and self-reported behavioral sleep problems, including nocturnal enuresis, bedtime resistance, nighttime awakenings, nightmares, and fatigue in pediatric brain tumor survivors.~The Study focuses on the following secondary objectives:~To describe bedtime patterns and sleep hygiene of pediatric brain tumor survivors.~Estimate the typical parent- and self-reported weekday sleep duration of pediatric brain tumor survivors~Estimate the typical parent- and self-reported weekend sleep duration of pediatric brain tumor survivors and if it differs from the weekday sleep duration~Estimate the typical parent- and self-reported consistency of sleep hygiene in pediatric brain tumor survivors
Inclusion criteria: inclusion criteria:

 Age ≥8 to ≤ 18 years of age

 Brain tumor survivor

 ≥5 years post diagnosis

 ≥2 years post active cancer-directed therapy or observation only

 Parents speak and read English fluently

 Potential participant reads English fluently

 Potential participant/guardian willing to sign consent

Exclusion criteria: :

 Survivor of any cancer other than a brain tumor.


Bioequivalence Study of Felodipine ER Tablets 10 mg Under Fed Conditions

Summary: The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing felodipine extended release tablets USP 10 mg (containing felodipine 10 mg) manufactured by OHM Laboratories Inc., NJ, 08901 with PLENDIL® extended release tablets 10 mg (containing felodipine 10 mg) manufactured by Merck & Co. Inc. Whitehouse Station, NJ 08889 USA for AstraZeneca LP Wilmington, DE 19850 in healthy, adult, male, human subjects under fed condition.
Inclusion criteria: inclusion criteria:

 Volunteers who met the following criteria were included in the study

 Were in the age range of 18-45 years.

 Were neither overweight nor underweight for their height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.

 Had voluntarily given written informed consent to participate in this study.

 Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.

 Had a non-vegetarian diet habit.

Exclusion criteria: :

 History of known hypersensitivity to Felodipine, related drugs and or any other drug

 Individuals with systolic blood pressure <100 mmHg or >140mmHg diastolic blood pressure < 60 mmHg or >90 mmHg, at the time of admission in period I.

 History of chronic headache, dizziness and syncope.

 History of peripheral edema.

 History of grapefruit juice and / or grapefruit supplements intake in past 48 hours.

 Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations

 Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.

 Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for hemoglobin, total white blood cells count, differential WBC count or platelet count.

 Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids).

 Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol.

 Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), glucose (positive) or protein (positive).

 Clinically abnormal ECG or Chest X-ray.

 History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes or glaucoma.

 History of any psychiatric illness which might impair the ability to provide written informed consent.

 Regular smokers who smoked more than 10 cigarettes daily or had difficulty abstaining from smoking for the duration of each study period.

 History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or had difficulty in abstaining for the duration of each study period.

 Use of any enzyme modifying drugs within 30 days prior to Day 1 of the study.

 Participation in any clinical trial within 12 weeks preceding Day 1 of the study.

 Subjects who, through completion of this study, would have donated and/or lost more than 350 mL of blood in the past 3 months.


Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis

Summary: Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a routine operation. At the same time other similar intra-abdominal infections, such as diverticulitis, are treated with antibiotics. There have been some encouraging reports on successful treatment of appendicitis with antibiotics and it has been estimated that operative treatment might be necessary for only 15 - 20 % of patients with acute appendicitis.~The aim of this randomized prospective study is to compare operative treatment (open appendicectomy) with conservative treatment with antibiotics (ertapenem, Invanz). Before randomization acute uncomplicated appendicitis is diagnosed with a CT scan.The hypothesis of the study is that the majority of patients with uncomplicated acute appendicitis can be treated successfully with antibiotics and unnecessary appendicectomies can be avoided.
Inclusion criteria: inclusion criteria:

 Age range from 18 to 60 years

 CT scan diagnosed uncomplicated acute appendicitis

Exclusion criteria: :

 Age under 18 years or age over 60 years

 Pregnancy or breast-feeding

 Allergy to contrast media or iodine

 Renal insufficiency

 metformin medication (DM)

 Peritonitis (a perforated appendix)

 Lack of co-operation (unable to give consent)

 A severe other medical condition

 CT-scan: other diagnosis, fecal lithiasis in appendix, perforation, abscess, suspicion of a tumour


Neuropsychological Characterization of Patients With Bipolar Disorder and a History of Suicide Attempt

Summary: The main objective of this study is to evaluate decision-making using the Iowa Gambling Task (IGT) among patients with euthymic bipolar disorder according to their personal history of suicide attempt (suicidal vs. not suicidal ).
Inclusion criteria: inclusion criteria:

 The patient was correctly informed about the study

 The patient must be insured or beneficiary of a health insurance plan

 The diagnosis of bipolar disorder is confirmed by the doctor referring the patient to the BEC and confirmed during the preliminary interview at the BEC

 The patient is euthymic on the day of inclusion. This is supported by a short psychiatric interview conducted at the BEC and the completion of the depression and mania scales (score <= 7 on the HDRS questionnaire and score <= 7 on the YMRS questionnaire).

 The patient is prescribed a mood stabilizer based on lithium or divalproex.

Exclusion criteria: :

 The patient is under judicial protection, under tutorship or curatorship

 The patient formalizes his/her opposition to the studyd

 It is impossible to correctly inform the patient

 The patient has mental retardation

 The patient has practiced substance abuse or dependence within the 6 months prior to study inclusion (alcool, cannabis, opiates, psychostimulants)

 The patient does not meet euthymic criteria (score <= 7 on the HDRS questionnaire and score <= 7 on the YMRS questionnaire).

 Uninclusion criteria:

 The patients withdraws consent during the study

 The patient does not understand directions necessary for the neurpsychological tasks

 The patient is not able to use a computer to complete the neuropsychological tasks

['Interview', 'Neuropsychological testing', 'Serum concentration of lithium or sodium divalproate.']


Iron Status and Hypoxic Pulmonary Vascular Responses

Summary: On exposure to hypoxia (low oxygen) the normal response is for pulmonary arterial systolic blood pressure (PASP, blood pressure through the lungs) to increase. We have previously shown that raising iron by giving an infusion of iron into a vein reduces this pressure rise and that lowering iron by giving a drug that binds iron, magnifies this response. This is potentially a clinically important observation since iron-deficient people may be at increased risk of pulmonary hypertension if exposed transiently or permanently to hypoxia due to lung disease or residence at high altitude; furthermore if this were true then intravenous iron could be an important treatment in this patient group in the event of hypoxic exposure. The observed effects of iron on PASP are likely to be because iron levels affect oxygen sensing. Low iron levels make the body behave as if exposed to low oxygen by inhibiting the breakdown of the family of oxygen-sensing transcription factors, 'hypoxia inducible factor' or HIF. This includes one of the body's normal responses to low oxygen levels - raising blood pressure through the lungs.~This study will answer the question (1) do iron-deficient volunteers have a greater rise in PASP with hypoxia than those who are iron-replete, and (2) does giving intravenous iron cause a greater reduction in the rise in PASP in those who are iron-deficient than iron-replete? The purpose of this study is not to test the safety or clinical efficacy of iron which is already known.
Inclusion criteria: inclusion criteria:

 Willing and able to give informed consent for participation in the study

 Men and women aged 18 years or older and generally in good health

 Detectable tricuspid regurgitation on echocardiography during both normoxia and hypoxia enabling measurement of pulmonary arterial pressure

 For iron-deficient volunteers: ferritin ≤15microg/L and transferrin saturation <16%

 For iron-replete volunteers: ferritin ≥20microg/L and transferrin saturation ≥20%

Exclusion criteria: :

 Haemoglobin <8.0g/dl

 Haemoglobinopathy

 Iron overload defined as ferritin >300microg/L

 Hypoxia at rest or on walking (SaO2 <94%) or significant comorbidity that may affect haematinics, pulmonary vascular or ventilatory responses, e.g. current infection, a chronic inflammatory condition, known cardiovalvular lesion or pulmonary hypertension, uncontrolled asthma or chronic obstructive pulmonary disease

 Exposure to high altitude (>2,500m) within the previous six weeks or air travel >4 hours within the previous week

 Iron supplementation or blood transfusion within the previous 6 weeks

 Pregnancy or breast feeding

['Intravenous administration of ferric carboxymaltose', 'Subacute hypoxic exposures']

['Lung Hypoxia', 'Pulmonary Arterial Hypertension', 'Iron Deficiency']

Lung Hypoxia
Pulmonary Arterial Hypertension
Iron Deficiency


Safety of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Children

Summary: Haemophilus influenzae is an important pathogen which can cause primary infection and respiratory viral infection in infants and leaded to secondary infections. The infection of haemophilus is a major cause of morbidity and mortality in infants and children. At present, the developed conjugant Hib vaccine is proved to be safe and effective, 90-99% of children will produce antibody of protection after 3 doses. Because Hib vaccine can prevent meningitis, pneumonia, epiglottis inflammation and other serious infection caused by Hib bacteria, the WHO suggested that Hib vaccine should be included in the infant's normal immune programming.~Since the use of meningitis aureus polysaccharide vaccine, incidence of a disease in recent years is declined and maintain to the level of 0.5 per 1/100 thousand. But meningitis aureus polysaccharide vaccine with a relatively poor immune response in the infants under the age of two, and the remaining 60% with a low antibody level and a short duration.~According to the present immunization schedule, to reach the median level of antibody levels there are at least 4 doses in need. So it is meaningful to improving vaccine immunogenicity, to provide high levels of long-term protection and to reduce the number of injections.~The objective of this study is to evaluate the safety of the group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine.
Inclusion criteria: inclusion criteria:

 Healthy subjects aged from 6 months to 5years old of normal intelligence

 The subjects'guardians are able to understand and sign the informed consent

 Subjects established as healthy after medical history questioning,physical examination and clinical decision and in accordance with vaccination requirements of the experimental vaccine

 Subjects who can comply with the requirements of the clinical trial program according to the researcher's views

 Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine

 Subjects with temperature <37°C on axillary setting

Exclusion criteria: :

['0.5ml/dose for a person', '0.5ml/dose for a person']

0.5ml/dose for a person
0.5ml/dose for a person


TASALL - TachoSil® Against Liquor Leak

Summary: The primary objective is to demonstrate superiority of TachoSil® compared to current practice as an adjunct in sealing the dura mater. The efficacy of the dura mater sealing must be evaluated post-operatively. The secondary objective is to evaluate the safety of TachoSil® as an adjunct in sealing the dura mater.~The trial population will consist of 726 randomised (1:1) patients elected for skull base surgery. The trial duration consists of screening, surgery, efficacy follow-up after 7±1 weeks and safety follow-up 28±2 weeks after surgery.
Inclusion criteria: Main inclusion criteria (Positive response):

 • Is the surgical approach/procedure consistent with skull base surgery? I.e. one of the following:

 Lateral approach to the foramen magnum: Far lateral, extreme lateral, anterolateral, posterolateral

 Approach to the jugular foramen: Infratemporal, juxta condylar, transjugular

 Approach to the cerebello pontine (CP) angle and petrous apex retrosigmoid

 Approach to the middle fossa: Subtemporal (+/- petrous apex drilling), pterional approach (any fronto temporal approach +/- orbitozygomatic deposition)

 Approach to the anterior fossa: Subfrontal (uni or bilateral)

 Approach to the midline posterior fossa

 Main
Exclusion criteria:  (Negative response):

 Has the patient been subject to neurosurgery involving opening of the dura mater within the last 3 months?

 Is the patient anticipated to undergo any additional neurosurgery involving opening of the dura mater which may affect the efficacy evaluation (e.g. re-operation or anticipation to undergo several neurosurgeries) before the Efficacy Follow-up Week 7±1 week?

 Is the patient anticipated to undergo any additional neurosurgery involving opening of the dura mater which may affect the safety evaluation (e.g. re-operation or anticipation to undergo several neurosurgeries) before the Safety Follow-up Week 28±2 weeks?

 The surgical approach/procedure is consistent with any transcranial or transfacial or combination of transcranial - transfacial approaches with wide defect in the skull base? I.e. any of the following:

 Trans basal approach

 Total petrosectomy

 Trans facial approach

 Trans sphenoidal approach

 Endoscopic procedures

 Trans oral approach (and any extension: Le Fort, mandibulotomy)

 The surgical approach is consistent with one of the following approaches?

 Translabyrinthine approach

 Retrolabyrinthine approach

 Transcochlear (limited transpetrosal) approach

 Did the arachnoid membrane and the CSF containing system remain intact during surgery?

 Does the patient have more than one dura opening (not including dura openings from extraventricular or lumbar drains)?

 Has TachoSil, fibrin or polymer sealants been used during the current surgery prior to randomization?


Study to Evaluate the Efficacy of Lithium Carbonate in Spinal Cord Injury Patients With Neuropathic Pain

Summary: To investigate the efficacy of lithium carbonate in the treatment of neuropathic pain of patients with spinal cord injury.
Inclusion criteria: inclusion criteria:

 Age 18 - 65;

 Diagnosis of traumatic spinal cord injury;

 Clinically diagnosed neuropathic pain;

 Pain severity is at least 4 on a 11-point numeric rating scale at screening;

 Pain present regularly for at least 6 weeks before enrollment;

 Able to understand instructions and provide reliable pain assessments;

 Subjects who are voluntarily signed and dated an Ethics Committee approved informed consent form;

Exclusion criteria: :

 Significant renal, cardiovascular, hepatic, infectious or psychiatric disease;

 Significant brain injury with neurological deficits;

 Debilitation or dehydration;

 Addison's disease;

 Recent (within 1 week) or current use of anti-diuretics or other drugs that interacts with lithium, such as tricyclic antidepressants, nonsteroidal antiinflammatory drug and tetracyclines;

 A history of substance or alcohol abuse within past 1 year;

 A need for elective surgery involving preoperative or postoperative analgesics or anesthetics during the study period;

 Current pregnant or breast feeding, or female who has childbearing potential but is not willing to use an approved method of birth control;

 Participation in any drug study in the last three months;

 History of oral lithium intake for any reason; or

 any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.

['Neuropathic Pain', 'Neuralgia', 'Spinal Cord Injuries']

Neuropathic Pain
Neuralgia
Spinal Cord Injuries


Effect of Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea on Resistant Hypertension

Summary: The objectives of this study are to investigate the effect of continuous positive airway pressure (CPAP) treatment on blood pressure control and vascular inflammation in subjects with resistant hypertension and moderate obstructive sleep apnea (OSA).
Inclusion criteria: inclusion criteria:

 Age 18 - 65

 known hypertension on ≧ 3 anti-hypertensive drugs

 Apnea-hypopnea index ≧15

 able to give informed written consent

Exclusion criteria: :

 moderate renal impairment (glomerular filtration rate <30 mL/min/m2 )

 endocrine/renal/cardiac causes of secondary HT

 congestive heart failure and clinically fluid overloaded

 On drugs that elevates BP e.g. NSAID, steroid

 Non-compliance to anti-hypertensive medications

 Unstable medical conditions such as unstable angina, recent myocardial infarction/stroke within 3 months

 Active inflammatory/infective conditions e.g. rheumatoid arthritis

 Excessive sleepiness that can be risky e.g. occupational driver, machine operator

 Modification/changes of anti-hypertensive regimen within 8 weeks

['Resistant Hypertension', 'Obstructive Sleep Apnea']

Resistant Hypertension
Obstructive Sleep Apnea


Swedish Drug-elution Trial in Peripheral Arterial Disease

Summary: Peripheral arterial disease (PAD) causes reduced blood flow to the lower limb(s) due to stenosis or occlusion in the supplying arteries. Symptoms of PAD range from ischemic rest pain and/or ischemic ulcers/gangrene (critical limb ischemia), putting the extremity at risk of amputation, to exercise-induced pain (intermittent claudication), limiting the patients daily activities. Invasive treatments are often indicated to prevent amputations and to alleviate symptoms. More than two thirds of these procedures are presently performed with endovascular techniques (i.e. percutaneous transluminal angioplasty, PTA with or without stent implantation).~In coronary artery disease, stents eluting anti-proliferative drugs (drug eluting stents, DES) reduce restenosis and improve clinical results for the majority of patients. Drug eluting balloons (DEB) are a promising alternative, but there is still little evidence that DES or DEB technology improve clinical outcome in PAD. However, promising results utilizing these new technologies in PAD have been reported in a few studies.~In this trial, we test the hypothesis that drug eluting (DE) technology is superior to conventional endovascular treatment (no-DE) in terms of important clinical outcomes, when applied on infrainguinal (femoropopliteal and/or infrapopliteal) obstructive vascular lesions. The trial consists of 2 separate parallel studies, SWEDEPAD 1 and SWEDEPAD 2, each defined by the severity of peripheral arterial disease. Patients with critical limb ischemia are allocated to SWEDEPAD 1 and patients with intermittent claudication are allocated to SWEDEPAD 2.
Inclusion criteria: inclusion criteria:

 All adults > 18 years old willing to be randomized

 Symptomatic PAD (critical limb ischemia or intermittent claudication) caused by >50% stenosis or occlusion of infrainguinal arteries and eligible for endovascular treatment according to established indications

Exclusion criteria: :

 Acute thromboembolic disease in the leg

 Infrainguinal aneurysmal disease

 Previous participation in the study or in other randomised interventional study of infrainguinal lesions

 Patients without a Swedish personal identification number

['Revascularization with drug-eluting technology', 'Revascularization without drug-eluting technology', 'drug-coated balloons and/or drug-eluting stents']

['Peripheral Arterial Disease', 'Critical Limb Ischemia', 'Intermittent Claudication']

Peripheral Arterial Disease
Critical Limb Ischemia
Intermittent Claudication


Study of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy Children

Summary: The purpose of this study is to evaluate the safety, immunogenicity and tolerability of TBE vaccines administered to children.
Inclusion criteria: inclusion criteria:

 Healthy male and female children, 1 to 10 years of age.

Exclusion criteria: :

 Subjects with documented evidence of TBE

 Subjects, who have been previously vaccinated against TBE


University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol

Summary: The objective of this protocol is to use established standard criteria and methods for the collection of hMSC (human mesenchymal stromal cells) from healthy bone marrow donors. The hMSC collected from the donors will use to develop well-defined and reproducible cell banks. Standard manufacturing procedures and quality control testing methods will be used to characterize and evaluate the final cell product. After the cell banks are created, these cell products will be used in future translational or clinical research.
Inclusion criteria: inclusion criteria:

 Age 18 to 35 years

 Willingness to provide written informed consent

Exclusion criteria: :

 Presence of risk factors for or clinical evidence of Human immunodeficiency virus (type 1 and 2), Hepatitis B, Hepatitis C, Human T-lymphotrophic virus (type I and II), Human transmissible spongiform encephalopathy (including Creutzfeldt-Jakob disease) treponema pallidum,

 Presence of communicable disease risk associated with xenotransplantation.

 Test positive for Human immunodeficiency virus (type 1 and 2), Hepatitis B, Hepatitis C, Human T-lymphotrophic virus (type I and II), cytomegalovirus (CVM), West Nile Virus, treponema pallidum.

 Use of investigational drug within 30 days or 5 half lives which ever is longer. Use of investigational implanted device.

 History of malignancy.

 Pregnancy

 In the opinion of the hematologist or the investigator, a condition that compromises the ability of the donor to safely provide BM donation.

['Graft Versus Host Disease (GVHD)', 'Acute Myocardial Infarction (AMI)']

Graft Versus Host Disease (GVHD)
Acute Myocardial Infarction (AMI)


Validation of Lophius Kits T-Track® CMV and T-Track® EBV in Hemodialysis Patients

Summary: Cell-mediated immunity (CMI) and in particular T cells play a critical role in the rejection of transplanted organs. Thus, in transplant recipients a life-long and individualized immunosuppressive medication is required to avoid graft rejection. However, a too weak suppression of CMI causes acute and chronic graft damage leading to transplant loss, whereas a too potent suppression of CMI supports opportunistic infections and reactivation of persistent viruses.~One of the biggest challenges in the field of transplantation is to provide a personalized immunosuppressive and antiviral therapy based on reliable assessment and monitoring of CMI. This could lead to a reduction of graft rejections and virus reactivations in transplant recipients.~With the development of both assays T-Track® CMV and T-Track® EBV, Lophius Biosciences GmbH has implemented its novel proprietary T-activation technology for an improved assessment of the functionality of CMI in cytomegalovirus (CMV)- and/or Epstein-Barr virus (EBV)-seropositive individuals. In contrast to other existing systems the Lophius assays open up the opportunity to characterize the functionality of CMI as an entire network.~The planned clinical multicenter study aims to verify the suitability of the two assays for a reliable assessment of the functionality of CMI.~Hemodialysis patients have been identified as an appropriate patient cohort for investigating the clinical sensitivity of the Lophius assays as these patients closely resemble kidney transplant recipients prior to an immunosuppressive therapy.~The determination of the functional CMI in the course of an immunosuppressive treatment may in future enable physicians to optimize the individual immunosuppressive and antiviral therapy in transplant recipients to reduce the risk of rejection as well as virus reactivations and associated diseases.
Inclusion criteria: inclusion criteria:

 Patient being hemodialysis-dependent due to end-stage kidney disease

 Male or female patient at least 18 years of age

 Written informed consent

Exclusion criteria: :

 Patient requires ongoing dosing with a systemic immunosuppressive drug

 Patient has received immunosuppressive therapy within the last three month

 Patient is known to be positive for HIV or suffering from chronic hepatitis infections

 Patient has significant uncontrolled concomitant infections or other unstable medical conditions that could interfere with the study objectives

 Patient has any form of substance abuse, psychiatric disorder or condition that, in the opinion of the investigator may invalidate communication with the investigator

['Renal Failure Chronic Requiring Dialysis']


Invasive Aspergillosis After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Summary: Evaluation of incidence of invasive aspergillosis in patients who have undergone an allogeneic stem cell transplantation, with particular regard to the role of galactomannan assay and of early TC scan in asymptomatic patients.
Inclusion criteria: inclusion criteria:

 Age > 16 years

 Allogeneic HSCT for a haematological disease

 Written informed consent to the study

Exclusion criteria: :

 Pediatric patients

['Hematological Diseases', 'Invasive Aspergillosis']

Hematological Diseases
Invasive Aspergillosis


The Effect of Pre-washing the Insemination Catheter on Pregnancy Outcome

Summary: The investigators hypothesize that washing the insemination catheter prior to performing the IUI (intrauterine insemination) will improve the pregnancy outcome in IUI cycles when compared to controls (without pre-washing the catheter).~Catheter washing is performed routinely before embryo transfer, however it is not done for IUI catheters. Therefore no data is available on applying the technique to IUI catheters prior to insemination.
Inclusion criteria: inclusion criteria:

 Infertile women age ranges from 18 to 40 years at the time of treatment at the MUHC reproductive centre.

 Patients undergoing IUI.

 Fresh and frozen sperm treatment cycles

 Hormone induced and natural cycle (no hormonal stimulation).

 Patients speaking English or/and French.

 Patients able to consent.

Exclusion criteria: :

 Patients younger than 18 years or older than 40 years of age.

 Patients undergoing ovarian stimulation without IUI.

 Patients who have been recruited in our study in a previous IUI cycle.

 Patients who don't speak English or French.

 Patients who are not able or refuse to consent.

 Patient who are recruited in a different IUI research study.

['washing the insemination catheter with sperm washing media']


Alternate Donor Study of Pre-Emptive Cellular Therapy

Summary: The purpose of this study is to evaluate the potential clinical benefit of pre-emptive cytomegalovirus (CMV)-specific adoptive cellular therapy following T cell depleted allogeneic hematopoietic stem cell transplantation (HSCT) for reducing recurrent CMV reactivation.
Inclusion criteria: inclusion criteria:

 Age 16 years or older

 cytomegalovirus seropositive allogeneic T cell depleted (alemtuzumab-containing conditioning regimen) hematopoietic stem cell transplant recipient with cytomegalovirus (CMV) seropositive unrelated donor

 Patient Informed consent

 Prepared to undergo additional study procedures as per study schedule

 Patient has undergone counselling about risk

 Donor engraftment (neutrophils > 0.5x109/l)(to be assessed prior to cytomegalovirus (CMV)-specific T cell infusion)

 Single positive cytomegalovirus PCR result (And to be assessed prior to cytomegalovirus (CMV)-specific T cell infusion)

 The donor will be selected from the Anthony Nolan Trust registry or other donor registries that have approved the protocol and consent procedure.

 Donor must have met requirements of EU Tissue and Cells Directive(2004/23/EC) as amended and the UK statutory instruments pursuant therein.

 Healthy, Cytomegalovirus (CMV)seropositive donor - having passed medical for stem cell donation

 Subject and Donor must have negative serology for Human immunodeficiency virus (HIV), Hepatitis B and C, syphilis

 human leukocyte antigen (HLA) type A*0101, A*0201, A*2402, B*0702 and B*0801

 Donor informed consent for stem cell mobilisation leucapheresis and storage

Exclusion criteria: :

 Pregnant or lactating women

 Co-existing medical problems that would place the patient at significant risk of death due to Graft versus Host Disease (GVHD) or its sequelae

 Human immunodeficiency virus infection

 Active acute Graft versus Host Disease (GVHD) > Grade I (to be assessed prior to CMV-specific T cell infusion )

 Concurrent use of systemic corticosteroids(to be assessed prior to cytomegalovirus (CMV)-specific T cell infusion )

 Organ dysfunction (to be assessed prior to cytomegalovirus-specific T cell infusion ) as measured by:

 creatinine > 200 uM/l

 bilirubin > 50 uM/l

 alanine transferase > 3x upper limit of normal

 Donor pregnant or lactating

 Donor platelets < 50x109/l

['CMV-specific T-cells, single infusion following single positive CMV PCR result']


Assessing the Health Impact of a Combined Water and Sanitation Intervention in Rural Odisha, India

Summary: This is a matched-cohort study designed to assess the health impact of a rural demand-driven water and sanitation intervention that provides piped treated water and household level pour-flush latrines and bathing rooms, as implemented by Gram Vikas.
Inclusion criteria: inclusion criteria:

 Households in participating villages will be eligible to participate in the study if they have at least one child under 5 years.

Exclusion criteria: :

 None

['Improved water supply and sanitation']

['Diarrhea', 'Enteric Infection', 'Soil-transmitted Helminth Infection', 'Stunting']

Diarrhea
Enteric Infection
Soil-transmitted Helminth Infection
Stunting


Effect of High-dose Oral Rabeprazole on Recurrent Bleeding After the Endoscopic Treatment of Bleeding Peptic Ulcers

Summary: This study is conducted to compare and evaluate the effect of administering a high-dose intravenous proton pump inhibitors or high-dose oral Rabeprazole in preventing recurrent bleeding after the endoscopic treatment of bleeding peptic ulcers.
Inclusion criteria: inclusion criteria:

 Bleeding peptic ulcer: Among patients suspected to have upper GI bleeding based on hematemesis or melena, those with peptic ulcers(Forrest I, IIa and IIb) in whom active bleeding, non-bleeding visible vessels and fresh blood clots are observed on upper GI endoscopy performed within 24 hours after the hospitalization

 patients who achieved primary hemostasis with endoscopic hemostasis procedure via upper GI endoscopy

Exclusion criteria: :

 Patients who refuse endoscopic procedure

 Patients with complications from gastric ulcer that require operative treatment prior to upper GI endoscopic treatment(e.g., gastric outlet obstruction, peptic ulcer perforation)

 Pregnancy

 Patients with serious concurrent diseases such as malignant tumors or end-stage diseases

 History of previous gastrectomy or vagotomy

 Known hypersensitivity to proton pump inhibitors

 Elderly patients

 Epilepsy


CKD-828 Primary Hypertension Trial(Dose-selection)

Summary: The aim of this trial is to determine the best dose combination of S-Amlodipine and Telmisartan as compared to monotherapy by assessing the blood pressure lowering effects of a once daily regimen of various combinations of S-Amlodipine and Telmisartan, compared to their monotherapy components and placebo, in patients with stage I or II essential hypertension(a mean seated cuff diastolic blood pressure >=95 and <=115 mmHg).
Inclusion criteria: inclusion criteria:

 age 18 years or older

 stage I or II hypertension defined as: a mean seated cuff diastolic blood pressure >=95 and <=115 mmHg

 ability to provide written informed consent

Exclusion criteria: :

 severe hypertension defined as: a mean seated cuff diastolic blood pressure >=116mmHg or a mean seated cuff systolic blood pressure >=200mmHg

 known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)

 has severe heart disease(Heart failure NYHA functional class 3, 4), unstable angina or myocardial infarction, arrhythmia within the past three months

 has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months

 Type I Diabets Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c) > 8%

 known severe or malignant retinopathy

 hepatic or renal dysfunction as defined by the following laboratory parameters: AST/ALT > UNL X 2, serum creatinine > UNL X 1.5

 acute or chronic inflammatory status need to treatment

 need to additional antihypertensive drugs during the study

 need to concomitant medications known to affect blood pressure during the study

 history of angioedema related to ACE inhibitors or Angiotensin II Receptor Blockers

 known hypersensitivity related to either study drug

 history of drug or alcohol dependency

 any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products(ex. gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bypass, active inflammatory bowel syndrome within 12 months prior to screening, currently active gatritis, ulcers of gastrointetinal/rectal bleeding, impaired pancreatic fuction such as pancreatitis,obstructions of the urinary tract or difficulty in voiding)

 cannot swallow investigational products

 administration of other study drugs within 4 weeks prior to randomization

 premenopausal women(last menstration < 1year) not using adequte contraception, pregnant or breast-feeding

 history of malignancy including leukemia and lymphoma within the past 5 years

 in investigator's judgment

['S-Amlodipine, Telmisartan', 'S-Amlodipine', 'Telmisartan', 'Placebo']

S-Amlodipine Telmisartan S-Amlodipine Telmisartan Placebo


Gardasil Vaccination as Therapy in Low Grade Cervical Abnormalities

Summary: This project will compare the rate of regression of minimally abnormal Pap smears to normal in women who receive Gardasil to a historical control group.~Research hypothesis: Women with low grade cervical dysplasia on Papanicolaou (Pap) smear that receive Gardasil vaccination will revert to a normal within one year at a rate 33% higher than historical controls that did not receive Gardasil vaccination.
Inclusion criteria: inclusion criteria:

 Women between 18 and 26 years of age

 Women able to consent for themselves

 Referring Pap smear was ASCUS, + HPV or LGSIL

 Women who decide they wish to get the Gardasil vaccination series

Exclusion criteria: :

 Women who have had previous cryotherapy of the cervix, LEEP or cervical conization

 Women who had their first Gardasil injection prior to their referring Pap smear

 Women under the age of 18

 Women unable to consent for themselves

 Women who are pregnant currently trying to conceive

 Women in an immunocompromised state (diabetes, HIV, on chronic immunosuppressants or steroids, etc)

 Women who do not want the Gardasil vaccination series

['human papillomavirus vaccine L1, type 6,11,16,18']

human papillomavirus vaccine L1
type 6,11,16,18


Cutaneous Lupus Erythematosus and Elidel

Summary: This trial evaluates the therapeutic effect of Elidel (pimecrolimus) in comparison to the corresponding vehicle in patients with chronic discoid lupus erythematosus (dLE) or subacute cutaneous lupus erythematosus (scLE).
Inclusion criteria: inclusion criteria:

 Subjects may be included only if they fulfil the following inclusion criteria on the pre-treatment days (between Day -14 and Day -2) and on Day 1 (before first application of study medication):

 Female and male patients aged 18-65 years (females of childbearing potential may be enrolled provided they are routinely using adequate contraception in the assessment of the investigator).

 Patients with histologically defined dLE or scLE.

 The test sites (lupus erythematosus plaques) must be on the face only, and have a total sign score of 4 or more (sum of erythema, induration and scaling scores) and must be the same within a given patient (ie not differing in the sum for erythema, induration or scaling). Each of the 2 test sites must be at least 3 cm apart.

 The patients must receive a baseline medication with chloroquine.

 Patients must have been informed about the study procedures and medication and must have given their written Informed Consent.

 Patients expected to be available for the duration of the study and able to comply with the study visits.

Exclusion criteria: :

 Any of the following criteria will disqualify a patient from participating in this study:

 Systemic therapy for lupus erythematosus within one month prior to first application of study medication in this study (steroids, retinoids, herbal medicines, etc) except chloroquine.

 Patients with systemic lupus erythematosus or patients whose chronic discoid lupus erythematosus appears to be spontaneously flaring or improving based on the experience of the investigator.

 Patients who are receiving oral medication, known to precipitate lupus lesions (e.g. procainamide, diuretics, piroxicam, beta blockers, griseofulvin, lithium and other psychotropic drugs).

 Topical therapy [i.e. corticosteroids, etc.] within 2 weeks prior to first application of study medication.

 Patients with clinically significant medical conditions which could interfere with the conduct of the study. This includes:

 Renal impairment (creatinine > 2.0 mg/dl)

 Hepatic impairment (liver function test values above notable abnormalities; g-GT, ALAT, ASAT: 2x the upper limit)

 Haematologic disorders (haemoglobin, platelet, erythrocyte and leukocyte counts above notable abnormalities)

 Neurologic disorders (significant impairment of sensory and motor function as judged by the investigator)

 Patients known to be previously immunocompromised (e.g. lymphoma, AIDS, myelodysplastic disorders) or treated recently with immunosuppressive drugs or treatment (e.g. radiation therapy or chemotherapy). HIV tests are not necessary.

 Patients with clinically relevant cardio-vascular diseases (New York Heart Association [NYHA] III or IV)

 Patients who suffer from systemic or generalized infections (bacterial, fungal, viral)

 Patients with malignancy or history of malignancy.

 Patients who suffer from acute or chronic bacterial, viral, or fungal skin diseases. However, patients with tinea pedum and/or onychomycosis can be included. Likewise, only patients with acute herpes lesions are excluded.

 Patients with a history of drug or alcohol abuse during the past 1 year.

 Patients with known hypersensitivity to any of the ingredients of the study medication or to tacrolimus (the investigator will be provided with a list of ingredients of the study medication).

 Patients who have received an investigational drug within 4 weeks prior to the first application of the study medication.

 Patients who are unwilling or unable to provide Informed Consent or to participate satisfactorily for the entire trial period.

 Any other condition which, in the opinion of the investigator, would render the patient ineligible for the study.

['Lupus Erythematosus, Cutaneous', 'Lupus Erythematosus, Discoid']

Lupus Erythematosus
Cutaneous
Lupus Erythematosus
Discoid


The Utility of Time Segmental Withdrawal During Screening Colonoscopy for Increasing Adenoma Detection Rate.

Summary: Colonoscopy( examining the colon with a flexible tube and a camera ) is usually done for screening purposes to find any precancerous lesions (polyps) at an early stage. During the colonoscopy the doctor will advance the colonoscope to the end of your colon and start examining the colon for any polyps. Withdrawal time is the period of time the doctor spends examining the colon. Doctors usually spend six minutes examining the colon after they reach the end of the colon. Studies have showed that spending more withdrawal time detects more lesions. The proposal to dedicating half of the withdrawal time during colonoscopy in examining the right side will increase the detection of polyps in the right side of the colon. There will be no other changes in the procedural aspect of the colonoscopy.
Inclusion criteria: inclusion criteria:

 Adult patients (18-80 years) who are undergoing colonoscopy for screening or surveillance purposes.

Exclusion criteria: :

 Patients with a prior history of colonic surgeries

 Patient with Crohns colitis or ulcerative colitis

 Patient with prior history of colon cancer

 Patient with poor bowel preparation

 Pregnant women


Long-Term Study of Hospitalized Dengue & Safety in Thai Children Included in a Tetravalent Dengue Vaccine Efficacy Study

Summary: The purpose of this study was to conduct a passive surveillance of hospitalized dengue cases in participants who participated in study CYD23 (NCT00842530).~The Objectives:~To describe the incidence of virologically-confirmed hospitalized dengue cases.~To characterize hospitalized dengue cases.~To evaluate the occurrence of related and fatal serious adverse events (SAEs).
Inclusion criteria: inclusion criteria:

 Ongoing participation in study CYD23 at the time of enrolment.

 Assent form was signed and dated by the participant (for participants >= 7 years old), and informed consent form was signed and dated by the parent(s) or another legally accepted representative and by 2 independent witnesses.

 Participant and parent/legally accepted representative were able to attend all scheduled visits to comply with all study procedures.

Exclusion criteria: :

 Planned participation in another dengue clinical trial during the present study

 Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.

['Dengue', 'Dengue Fever', 'Dengue Hemorrhagic Fever']

Dengue
Dengue Fever
Dengue Hemorrhagic Fever


Monitoring and Evaluation of the Levothyroxin Replacement Therapy in Pregnant Women With Hypothyroidism

Summary: The aim of the study was to evaluate the clinical control program in patients with hypothyroidism during pregnancy (suggested in resent guidelines). Is it possible by monitoring the patients every 4. week during pregnancy to keep the thyroid function parameters within the recommended range?~A retrospective study of consecutive pregnant women with hypothyroidism followed at the outpatient clinic at the Endocrinology Unit, Herlev Hospital, Denmark during 2012. Patients selected through electronic medical system. Blood tests for the The hormone levels drawn from the laboratory of Clinical Biochemical Department, Herlev Hospital
Inclusion criteria: inclusion criteria:

 Consecutive pregnant women with L-T4 treated hypothyroidism followed at the outpatient clinic at the Endocrinology Unit, Herlev Hospital, Denmark during 2012
Exclusion criteria:


Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) in Korea

Summary: This post marketing surveillance study in Korea will evaluate the safety and efficacy of BOTOX (botulinum toxin Type A) in patients who receive treatment according to standard of care for primary axillary hyperhidrosis, focal spasticity or moderate to severe glabellar lines in clinical practice.
Inclusion criteria: inclusion criteria:

 Patients treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice for primary axillary hyperhidrosis, focal spasticity or moderate to severe glabellar lines.

Exclusion criteria: :

 None.

['Hyperhidrosis', 'Muscle Spasticity', 'Glabellar Lines']

Hyperhidrosis
Muscle Spasticity
Glabellar Lines


Study to Assess Safety of an Inactivated H5N1 Influenza Vaccine Administered in GelVac Nasal Powder to Healthy Young Adults

Summary: This is a double-blind, placebo controlled, safety and immunogenicity study of GelVac™ nasal powder H5N1 influenza vaccine. Healthy male and female subjects between 18 and 49 years of age who are eligible for study participation will be enrolled in the trial. It is expected that 10 subjects will be screened to obtain 7 subjects who will be eligible for study participation.~The primary objective is to determine the frequency and severity of local and systemic adverse events of vaccine.~The secondary objective is to assess the immunogenicity of the vaccine based on geometric mean titers (GMT) of serum HAI, serum neutralizing, and nasal wash IgA antibodies.
Inclusion criteria: inclusion criteria:

 able to read and sign Informed Consent Form (ICF).

 male or female > 18 and < 49 years of age at the time the ICF is signed.

 generally healthy, as determined by medical history and clinical assessment.

 able to attend all scheduled visits and to comply with all trial procedures.

 if female of child-bearing potential, use of an acceptable method of contraception or abstinence for at least 4 weeks prior to the first vaccination through at least four weeks after the second vaccination. Acceptable methods are hormonal birth control or a barrier method with spermicide.

 if female, post menopausal (no menstrual period within the last 12 months), surgically sterile (hysterectomy or tubal ligation), or have a negative urine pregnancy test within 24 hours prior to the time of vaccination.

Exclusion criteria: :

 has a known allergy to fruits (e.g., apples, oranges) or pectin and/or pectin by-products (including jams or jellies).

 has a known allergy to dairy/milk products/lactose.

 is breast-feeding or pregnant or planning on becoming pregnant within 1 month of vaccination.

 has a history of a chronic viral infection (i.e.; Shingles, Herpes Zoster, HIV).

 has a history of severe allergic reaction following influenza vaccination, systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing the same substances.

 has a history of demyelinating disease (esp. Guillian-Barre Syndrome).

 history of Bell's Palsy.

 immunosuppression as a result of underlying illness or treatment.

 use of oral steroids, parenteral steroids, or high-dose inhaled steroids (>800 µg/day of beclomethasone dipropionate or equivalent) within 1 month prior to vaccination.

 use of other immunosuppressive or cytotoxic drugs or radiation therapy within six months prior to vaccination.

 use of OTC or other 'herbal' immune suppressant or stimulants within the 6 months prior to vaccination.

 active neoplastic disease or history of any hematologic malignancy in the past 5 years (except localized skin or prostate cancer that is stable in the absence of therapy).

 acute or chronic condition that (in the opinion of the Investigator) would render vaccination unsafe or would interfere with the evaluation of responses including, but not limited to the following: known chronic liver disease, significant renal disease, oxygen-dependent chronic lung disease, New York Heart Association Functional Class III or IV, unstable or progressive neurologic disorder, insulin-treated diabetes mellitus, and asthma.

 use of experimental vaccines within 6 months prior to study entry, or expected use of experimental vaccines during the entire study period after inoculation with study vaccine.

 participation in another clinical trial 30 days prior to study entry.

 use of experimental devices or participation in a medical procedure trial within the month prior to study entry, or expected use of experimental devices or participation in a medical procedure trial during the entire study period.

 receipt of immunoglobulin or other blood product within 3 months prior to enrollment.

 receipt of other licensed vaccines within the preceding 6 months or expected to receive a licensed vaccine within 28 days following last trial vaccination.

 subject is enrolled in a conflicting clinical trial.

 any disorder or therapy contraindicating influenza vaccination.

 Have a clinically significant structural abnormality of the nasopharynx (e.g., obvious deviation that obstructs airflow in either nostril), as determined by the investigator

 acute respiratory disease at the time of enrollment.

 febrile illness with temperature greater than or equal to 38 degrees Celsius (100.4 degrees F) within 72 hours prior to enrollment.

 receipt of allergy shots within the preceding 7 days or expected to receive allergy shots within 7 days following vaccination.

 any condition that, in the opinion of the investigator, would pose a health risk to the participant.

 presence of any active disease or condition at the administration site that, in the opinion of the Investigator, would impact vaccine delivery or assessment of vaccination site.

 history of drug abuse or alcohol abuse in the five years prior to enrollment. Subject who abuses alcohol or other drugs of abuse.

['GelVac™ nasal powder H5N1 influenza vaccine.', 'Placebo']

['Phase 1 Safety Study of GelVac Nasal Powder H5N1 Influenza Vaccine']


Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis

Summary: The aim of this study is to compare parenteral ceftriaxone and oral doxycycline in the treatment of neuroborreliosis in a randomized controlled trial.
Inclusion criteria: inclusion criteria:

 Neurological symptoms and/or findings consistent with neuroborreliosis and at least one of the following fulfilled:

 Intrathecal production of borrelia antibodies;

 White cell count in cerebrospinal fluid (CSF) > 5/mm3;

 Significant rise in borrelia antibodies in two serum samples collected from a patient with at least 3 weeks interval;

 Verified acrodermatitis chronica atrophicans.

Exclusion criteria: :

 Allergy to the contents in the medication, or earlier type I reaction to penicillin.

 Treatment with cephalosporins, penicillin or tetracyclins during the last 14 days

 Pregnancy or breastfeeding

 Age < 18 years