Fractional Concentration of Exhaled NO(FENO) to Direct Montelukast Treatment of Sub-acute Cough

Summary: Cough is a common symptom of respiratory medicine clinic patients, which has complex etiology and wide-ranging. Cough is usually divided into three categories by time: acute cough, subacute cough and chronic cough. Subacute has a 3~8 weeks course of disease. Its main etiology is postinfectious cough, which is mostly secondary to viral infection.Considering its overexpression in postinfectious patient, Cysteinyl leukotriene (CysLTs) plays a role in gathering eosinophils to respiratory. The level of FENO has a significant correlation with inflammatory airway eosinophils. While CysLTs overexpressed in vivo, the level of FENO may increase. Montelukast, as CysLTs-receptor-1 antagonists， plays a role of controlling airway inflammation and decrease airway high activity by suppressing the biological activity of CysLTs. It is effective in theory to therapy sub-acute cough by Montelukast, to short the course and to relieve cough symptoms as soon as possible. The aim is to research whether FENO can be used as a biomarker to optimized treatment regimen of sub-acute cough.
Inclusion criteria: inclusion criteria:

 Cough is the main or only clinical symptom and was persistent for 3-8 weeks

 Chest X-ray reveals no noticeable pathological changes

 ≥18 year old, regardless of gender and ethical background

 Not taking angiotensin-converting enzyme inhibitor

 Patients must join the programme voluntarily and are able to attend examination and follow-up sessions

Exclusion criteria: :

 Patients diagnosed with rhinallergosis, chronic nasosinusitis or bacterial respiratory tract infections

 Patients diagnosed with severe reportorial disease of other severe systemic disease

 Patients who are allergic to any drugs to be tested

 Patients who are non-cooperative during examination sessions or other steps of the trial

 Patients who are not able to or refuse to sign consent


Exploratory Study of Changes in Disease Activity and Biomarkers With ABR-215757 in Patients With Mild Active Systemic Lupus Erythematosus (SLE)

Summary: This is an exploratory open label single arm study to evaluate changes in disease activity and biomarkers in patients with mild active SLE, during treatment with ABR-215757 given as add-on to standard therapy. To be eligible for the study SLE patients should present with symptoms from skin, mouth and/or joints. After a screening period of one week patients will be treated with ABR-215757 for 12 weeks. The initial dose of ABR-215757 will be 1.5 mg/day. There will be an option to increase the dose to 3.0 mg/day following 28 days of treatment. Follow-up visits will take place 4 weeks and 8 weeks after last day of treatment. Disease activity during treatment will be studied using the Systemic Lupus Erythematosus disease Activity Index (SLEDAI-2K) as well as organ system specific disease activity indexes (CLASI for skin involvement and number of swollen/tender joints using 28- and 66/68-joint counts). At specified time points during the study, blood samples and biopsies will be collected for analysis of established and exploratory biomarkers of SLE. Concomitant SLE treatment allowed include: prednisolone or equivalent at a dose of ≤15 mg/day, hydroxychloroquine, azathioprine, methotrexate and mycophenolate mofetil, all at stable doses from specified timepoints prior to the study and throughout the study.
Inclusion criteria: inclusion criteria:

 Age > 18 years at the time of signing the informed consent form

 Fulfil at least 4 criteria for SLE as defined by the American College of Rheumatology (ACR)

 Present with active SLE disease with at least one of the following symptoms:

 i) Arthritis - > 2 joints with pain and signs of inflammation (i.e. tenderness, swelling, or effusion) ii) Inflammatory-type skin rash iii) Oral ulcers

 Laboratory values as follows

 Hemoglobin ≥ 100 g/L

 Absolute neutrophil count ≥ 1.0 x 109/L

 Total bilirubin ≤ 1.5 x upper limit of normal (ULN)

 AST (SGOT) / ALT (SGPT) ≤ 2.5 x ULN

 Ability to take and retain oral medication

 Ability to sign and date a written informed consent prior to entering the study

 Willingness and ability to comply with the protocol for the duration of the study

Exclusion criteria: :

 Active severe SLE flare with central nervous system (CNS) manifestations, active renal lupus, systemic vasculitis, active pericarditis, active pleuritis, active peritonitis or other SLE manifestations requiring treatment not allowed by the study protocol.

 Severe renal impairment (estimated or measured GFR <50%)

 Oral treatment with corticosteroids (>15 mg/day prednisolone or equivalent) or changes in corticosteroid dosing within 30 days prior to the first dose of study medication. This also includes intraarticular steroid injections or topical treatment for SLE symptoms. Inhaled or topical steroids may be given for reasons other than SLE disease activity (such as asthma, contact dermatitis) as clinically indicated.

 Intravenous corticosteroids within 3 months prior to the first dose of study medication.

 Intravenous cyclophosphamide within 6 months prior to the first dose of study medication.

 Treatment with anti-rheumatic/immunosuppressive drugs within 3 months prior to first dose of study medication, other than the following medications at stable doses: methotrexate (≤25 mg/week), azathioprine (≤2.5 mg/kg/day), hydroxychloroquine and mycophenolate mofetil (≤3000 mg/day).

 B-cell depletion therapy (such as treatment with Rituximab) within 12 months prior to the first dose of study medication.

 Potent inhibitors or inducers of CYP3A4 intravenously or orally within 14 days prior to first dose of study medication.

 History of myocardial infarction or current uncontrolled angina, severe uncontrolled ventricular arrhythmias, symptomatic congestive heart failure, unstable angina pectoris, or electrocardiographic evidence of acute ischemia.

 Marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval >450 milliseconds

 History of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome)

 Treatment with concomitant medications that prolong the QT interval.

 History of, or current, ischemic CNS disease.

 Current malignancy. A 5-year cancer-free period is required with the exception of skin basal or squamous cell carcinoma or cervical cancer in situ that has been excised.

 Current severe infection

 Positive result on screening for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV) antibodies.

 Drug abuse.

 Major surgery within 3 weeks prior to study entry.

 Known or suspected hypersensitivity to ABR-215757 or excipients.

 Female subject of child-bearing potential who is not using a medically accepted safe method of contraception. All female subjects of child-bearing potential must have a negative urine pregnancy test at the Screening and Baseline Visits. As interaction studies between ABR-215757 and oral contraceptives have not yet been performed, women using the contraceptive pill must also use a complementary contraceptive device, i.e. barrier method, during the treatment period and for at least 1 month thereafter.

 Female subject of child-bearing potential who is pregnant or lactating.

 Simultaneous participation or participation within 4 months or 5 half lives (whichever is longer) prior to study entry in any other study involving investigational drugs or other experimental therapy.

 Other significant, unstable medical disease not related to SLE that in the investigator's opinion would confound the study result or put the patient at risk.

 Patients likely to receive oral or intravenous steroids or immunosuppressant for other non-SLE condition during the study duration, as this will confound the study result.

 Vaccination within 4 weeks prior to the first dose of study medication.


Malezi Na Kilimo Bora - Skilful Parenting and Agribusiness Child Abuse Prevention Study

Summary: The Malezi ne Kilimo Bora (Good Parenting and Farming in Kiswahili) Skilful Parenting and Agribusiness Child Abuse Prevention Study is a collaboration between the University of Oxford, University of Glasgow, and the Tanzania National Medical Research Institute (NIMR). It is pilot cluster randomised controlled trial (cRCT) of a community-based intervention implemented by Investing in Children and Our Societies (ICS), an international non-governmental organization (NGO) with extensive experience operating in rural Tanzania. The overall focus of the project is to evaluate ICS's agribusiness and skilful parenting programmes' impact on the prevention of child maltreatment and improvement of child and family psychosocial and economic wellbeing (n = 8 villages, n = 16 farmer groups, n = 240 families).
Inclusion criteria: inclusion criteria for villages (n = 8):

 Situated within 1 hour driving distance from Shinyanga, Tanzania

 Provide community consent via community local leader and approval from local authorities

 Contain registered farmer groups

 inclusion criteria for participating farmer groups (n = 16, 2 per village):

 Situated within participating village

 Registered with Tanzanian Ministry of Agriculture within the previous 3 years

 Registered to participate in ICS's Agribusiness and Skilful Parenting programme

 Provide consent via farmer group leader

 inclusion criteria for adults caregivers (n = 240, 30 per village):

 Age 18 or older

 Serves as the primary caregiver of a child in the household between the ages of 3 and 17

 Lives in the house at least 4 nights per week.

 Is a registered member of the included agricultural farmer group

 Provides consent to participate in the full study

Exclusion criteria:  for adult participants:

 Any adult exhibiting severe mental health problems or acute mental disabilities.

 Any adult that has been referred to social services or child protection services during the course of baseline data collection as a result of reported or observed indications of significant potential psychological harm towards a child.

 inclusion criteria for child respondents (n = 240, 30 per village):

 Age 10 to 17 years at initial assessment

 Lives in the house at least 4 nights per week

 Must have an adult primary caregiver who lives in the household, who provides consent, and who participates in the study

 Provides assent to participate in the full study


Evaluation of Lung Doppler Signals in Pulmonary Hypertension

Summary: The purpose of this study is to evaluate the lung Doppler signals in patients with pulmonary hypertension that undergo (prospective arm) or underwent (retrospective arm) right heart catheterization (RHC) in order to assess whether this non-invasive tool could be used in pulmonary hypertension diagnosis and monitoring.
Inclusion criteria: inclusion criteria:

 Prospective arm:

 Man or woman aged over 18.

 With suspicion or diagnosis of pulmonary hypertension.

 Scheduled to undergo right heart catheterization

 Able and willing to give informed consent.

 Retrospective arm:

 Man or woman aged over 18.

 With diagnosis of pulmonary hypertension confirmed by right heart catheterization in the past.

 Able and willing to give informed consent.

Exclusion criteria: :

 Both arms:

 Minor (aged < 18).

 People unable or unwilling to give informed consent.

 Hemodynamically unstable patients.

 Pregnant women.

 Prospective arm only:

 Patients with contra-indication to right heart catheterization.

 Patients incapable of performing a Valsalva maneuver.

 Patients with recent myocardial infarction, high degree AV block, severe aortic stenosis or glaucoma


Biomarker Assay Validation in Healthy Smokers and COPD Smokers and Ex-smokers

Summary: This study will collect sputum samples from healthy smokers, COPD smokers and COPD ex-smokers to analyse biomarkers of inflammation
Inclusion criteria: inclusion criteria for Healthy Smoking Subjects

 Must have signed an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

 Be between 18 and 75 years of age, inclusive, at informed consent.

 Healthy as determined by a physician, based on medical history and physical examination.

 Must have smoked regularly in the 12-month period preceding the screening visit and have a pack history of ≥ 5 pack years (number of pack years = number of cigarettes per day/20 x number of years smoked).

 inclusion criteria for All COPD Subjects

 Must have signed an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

 Aged between 40 and 75 years of age inclusive, at the time of signing the informed consent.

 COPD diagnosis: Subjects with a diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines (Celli, 2004). Symptoms must be compatible with COPD for at least 1 year prior to screening and post-bronchodilator spirometry readings at screening:

 Post-bronchodilator FEV1/FVC ratio of <0.7

 Post-bronchodilator FEV ≥40 % and ≤80 % of predicted normal values calculated using NHANES reference equations.

 Additional Inclusion for Smoking COPD Subjects 1. Must have smoked regularly in the 12-month period preceding the screening visit and have a pack history of ≥ 5 pack years (number of pack years = number of cigarettes per day/20 x number of years smoked).

Exclusion criteria:  for Healthy Smoking Subjects Any potential subject who meets any of the following criteria will be excluded from the participating study.

 Upper or lower respiratory tract infection within 4 weeks of the screening visit.

 Positive test for alcohol at screening.

 Taking prescription medication in the 14 days before screening.

 Subjects whose primary consumption of tobacco is via methods other than cigarettes (manufactured or self-rolled). Primary methods of tobacco consumption that are excluded include, but are not limited to pipes, cigars and e-cigarettes.

 Subjects who are unable to produce a total weight of at least 0.1 grams (g) of selected sputum at screening

 Urinary cotinine levels at screening < 30 ng/ml.

 Subject is mentally or legally incapacitated.

 Subject is an employee of the Sponsor or contract research organization (CRO), or a relative of an employee of the Sponsor or CRO.

 Any other reason that the Investigator considers makes the subject unsuitable to participate.


Duration of Immobilization After Rotator Cuff Repair: Its Clinical Impact

Summary: The purpose of this study is to determine whether the immobilization period is helpful for the better healing of repaired rotator cuff.~The investigators hypothesis is that the longer immobilization after rotator cuff repair will help the healing of rotator cuff.
Inclusion criteria: inclusion criteria:

 Medium to large sized cuff tear (2-4 cm)

 Yes subscapular partial fraying or longitudinal split side to side

 Yes acromioplasty

 Yes AC arthritis with mumford procedure

 Yes biceps tenotomy or tenodesis

Exclusion criteria: :

 No arthritic changes of glenohumeral joint

 No combined infection

 No mini-open procedures

 No complete subscapularis tear

 No incomplete repair

 No small tears or side to side repairs without anchors

 No pregnancy


Forced Diuresis Versus Observation in Resolving Renal Failure After Haemofiltration in Critically Ill Patients

Summary: Intensive care patients with multiple organ dysfunction syndrome often show renal failure with the need for hemofiltration. Resolving renal failure after cessation of hemofiltration may or may not be accompanied by oliguria. Whether or not the administration of diuretics at that moment is appropriate is not known. The study randomises between furosemide or placebo when hemofiltration is stopped. Study endpoint is recovery of renal function.
Inclusion criteria: inclusion criteria:

 cessation of hemofiltration

 mechanical ventilation

 written informed consent

Exclusion criteria: :

 pre-existent renal failure

 glomerulonephritis


Aspirin and Statins for Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus

Summary: The purpose of this trial is to study if aspirin and statins (lipid-lowering agents) can reduce the progression of subclinical atherosclerosis in patients with systemic lupus erythematosus (SLE).
Inclusion criteria: inclusion criteria:

 Age > 18 years

 Fulfillment of at least 4 of the American College of Rheumatology (ACR) criteria for SLE

 Presence of any two of the following risk factors:

 SLE duration of >= 5 years

 Postmenopausal

 Age >= 40 years

 Diabetes mellitus

 Hypertension (140/90 mmHg)

 Serum low density lipoprotein (LDL) level >= 2.6 mmol/L or total cholesterol >= 5.5 mmol/L

 Obesity (body mass index >= 27 kg/m2)

 Chronic current smoker

 Positive antiphospholipid antibodies

 Renal function impairment

 Persistent proteinuria >= 1 gm/day for >= 6 months

 Informed consent obtained

Exclusion criteria: :

 Patients with known allergy to aspirin, or any other non-steroidal anti-inflammatory drugs (NSAIDs), or statins

 Patient with a history of severe gastrointestinal intolerance to aspirin (e.g., gastrointestinal bleeding) or other NSAIDs

 Patients with history of arterial or venous thromboembolism

 Patients receiving aspirin or other anti-platelet agents

 Patients receiving long-term non-aspirin NSAIDs

 Patients receiving anticoagulation therapy (e.g., warfarin)

 Patients with history of intolerance or allergy to the statins

 Pregnant or lactating women

['Rosuvastatin', 'placebo', 'aspirin', 'placebo']

['Atherosclerosis', 'Thromboembolism', 'Systemic Lupus Erythematosus']

Atherosclerosis
Thromboembolism
Systemic Lupus Erythematosus


Use of Loop Recorders for Diagnosis of Palpitations in A&E

Summary: Heart rhythm abnormalities underlie one of the common presenting complaints to the A&E and out-patient departments, specifically awareness of heart beats or palpitations. Unless an ECG (electrocardiogram) tracing of the heart rhythm can be recorded while the patient is having symptoms, it is very difficult to determine the cause of the palpitations. The conventional approach is to refer these patients from the emergency departments to the Cardiology outpatients where they undergo repeated short term rhythm monitoring hoping to record the rhythm underlying the patient's complaint. Unfortunately, this often yields no results thus delaying definitive treatment and incurring extra costs of repeated investigations and A&E presentations. This study aims to compare the ability of the conventional approach to establish a definite diagnosis compared to that of an early invasive monitoring approach with a small implantable device that records the heart rhythm at all time for up to 18 months.
Inclusion criteria: inclusion criteria:

 Age 18 years or older

 Good history of episodic symptomatic sustained palpitations (sudden onset and offset, fast heart beats, may be associated with shortness of breath or dizziness)

 Terminates before presentation to hospital

 Episodes occur at a frequency of less than once every two weeks

 Never previously caught on ECG or ambulatory monitoring

 Normal resting ECG

Exclusion criteria: :

 Contraindication to ILR implantation i.e. ongoing oral anticoagulation with INR >1.6, ongoing infection, sepsis or fever, etc.

 Palpitations suggestive of extrasystoles (single missed or dropped beats)

 Known or suspected severe valvular or myocardial heart disease

 An audible heart murmur

 Any abnormality on the surface ECG

 Thyrotoxicosis

 Patients who refuse an ILR when offered will not be included in either limb of the study


Vascular Endothelial Growth Factor (VEGF), Platelet Derived Growth Factor (PDGF), Hepatocyte Growth Factor (HGF) in Patients With Acute Coronary Syndrome (ACS)

Summary: The main aim of the study is a comparison of serum and plasma concentration of VEGF (Vascular Endothelial Growth Factor), HGF (Hepatocyte Growth Factor) and PDGF (Platelet Derived Growth Factor) with markers of myocardial injury as troponin I, hsCRP, CK-MB and NT-proBNP assessed in patients with first episode of acute coronary syndrome (ACS) in their lives and the estimation of assumed value of VEGF, HGF and PDGF in prognosis of cardiovascular complications at 3 months follow up especially with respect to myocardial infarction (MI), exacerbation of angina, reintervention (PTCA,CABG), symptoms of heart failure, stroke, rehospitalization due to cardiovascular reasons and death. The dynamics of changes in serum and plasma concentration of growth factors in comparison with values of myocardial injury markers will be checked. For the realization of the purpose of the study biochemical measurements will be performed twice i.e. just after admission to hospital and 24h later. Area of a myocardial injury will be estimated by echocardiography examination.
Inclusion criteria: inclusion criteria:

 typical chest pain;

 ST segment elevation or depression in ECG;

 indication for coronary angiography; if necessary with PCI and 4) signed inform consent.

Exclusion criteria: :

 known past history of a myocardial infarction;

 not signed informed consent.


Summary: This study will assess the acceptability and effectiveness of a six-session, modular, repeating group for low-income women who have symptoms of depression and/or post-traumatic stress disorder following interpersonal trauma exposure.
Inclusion criteria: inclusion criteria:

 Exposure to an interpersonal traumatic event

 Diagnosis of depression or PTSD (threshold or subthreshold)

 Functional literacy

Exclusion criteria: :

 Apparent incoherence or disorientation

 Apparent intoxication at recruitment

 Hearing impairment

['Group Intervention for Interpersonal Trauma', 'Information only']

['Post-Traumatic Stress Disorder', 'Depression']

Post-Traumatic Stress Disorder
Depression


Obstructive Sleep Apnoea and Adipose Tissue Dysfunction

Summary: Dysfunctional adipose tissue predisposes to cardiovascular disease. Similarly, the risk of cardiovascular disease appears to be increased in subjects with obstructive sleep apnoea. Reduced adipose tissue oxygen availability has been described in obesity and may also be a mechanism in obstructive sleep apnoea. Hypoxia induces inflammation and fibrosis in adipose tissue which are factors contributing to cardiovascular risk. The investigators hypothesize that adipose tissue's oxygen uptake is reduced in subjects with obstructive sleep apnoea by comparing in vivo AT oxygenation and blood flow in tissue of control subjects.
Inclusion criteria: inclusion criteria:

 men with or without obstructive sleep apnoea

Exclusion criteria: :

 weight loss interventions

 steroid use

 active smoking

['Continuous positive airway pressure devices']

['Obstructive Sleep Apnoea', 'Obesity', 'Hypoxia']

Obstructive Sleep Apnoea
Obesity
Hypoxia


Dose-Guided Radiotherapy in Oesophageal Cancer: Managing the Real Dose

Summary: This study will prospectively collect patients undergoing the standard CROSS regimen in the neoadjuvant setting of the treatment for gastro-oesophageal cancer. The investigators will focus on the potential geometric differences between the OAR and target volume on the initial planning CT and on the kilovolt (kV) cone-beam computed tomography (CBCT). They expect a potential difference in the abdominal part of the planned target volume (PTV) and/or gastro-oesophageal junction part. Furthermore, the impact of gastric filling , potential tumor regression and the accuracy of 5 mm PTV margin in the thoracic PTV will be monitored.
Inclusion criteria: inclusion criteria:

 Histologically proven adenocarcinoma of the gastro-oesophageal junction

 Age 18 years or older

 International Union Against Cancer (UICC) T2-4 N0-2 M0, potentially resectable disease treated by the CROSS regimen

 WHO 0-2

Exclusion criteria: :

 Thoracic adenocarcinoma/squamous cell carcinoma

 Palliative treatment for the oesophageal cancer


Effect of GlucoNorm vs Glyburide on Post-Prandial Hyperglycemia in Elderly Subjects With Type 2 Diabetes

Summary: The results from the DECODE Study have shown that postprandial (1 - 2 hours after a meal) hyperglycemia (elevated blood sugar) is more common in elderly people with diabetes than younger people with diabetes and is the best predictor of the development of complications. The DECODE Study involved 6941 people who already had diabetes and 702 who did not have diabetes. Diabetes is diagnosed when the blood sugar 1st thing in the morning is over 7.0 mmol/L. The DECODE Study showed that people at risk for diabetes can have a normal blood sugar 1st thing in the morning but have a high blood sugar 2 hours after a meal and that these people are at risk for developing heart disease and other complications of diabetes. These people would not be identified as at risk if only a fasting blood sugar is done. Studies in younger people with diabetes have shown that after a meal, insulin levels are more like a person without diabetes and glucose (blood sugar) levels are lower with GlucoNorm than with Glyburide. There is no data available that demonstrates this in elderly people with type 2 diabetes.~You have been invited to participate in this study because you have type 2 diabetes controlled by diet and/or exercise or metformin only and are over 65 years of age.~The purpose of this study is to determine whether GlucoNorm has a greater effect than Glyburide on insulin levels and glucose (blood sugar) levels after a meal in elderly people with type 2 diabetes who control their diabetes with diet and exercise.
Inclusion criteria: inclusion criteria:

 Type 2 diabetes > 3 months duration

 Male or female

 Over 65 years of age

 Diet controlled only

 HgbA1C < 8.5%

Exclusion criteria: :

 Treatment with oral hypoglycemic agents or insulin or the likelihood of requiring treatment with these during the study.

 Anemia - hgb below 130 g/L (males) and below 120 g/L (females).

 Taking medications that known to interfere with glucose metabolism eg systemic corticosteriods, non-selective beta blockers.

 Known or suspected allergy to glyburide, sulfa drugs or GlucoNorm impaired liver function, as shown by but not limited to AST and/or ALT > 2x the upper limit of normal.

 Impaired renal function, as shown by but not limited to serum creatinine > 133 µmol/L (males) or 124 µmol/L (females).

 Participated in another clinical trial within the past 30 days.


Effect of Vitamin E Supplementation on Hemoglobin Levels in Healthy Adults

Summary: Anemia is one of the major health problems of the developing countries of the world [1]. According to the WHO reference criteria, an adult is labeled as anemic, if the blood hemoglobin concentration falls below 13.0 g/dL in men or less than 12.0 g/dL in the non-pregnant women [2]. Hemoglobin concentrations below the lower limit of normal are a common laboratory finding in apparently healthy people in general population all over the world [3-5]. Many of these mildly anemic individuals are not investigated sufficiently to establish the probable cause of their anemia and thus may end up with morbidity and health problems, especially the young women in developing countries [4].~Only few studies on the use of vitamin E in the correction of anemia have been published and hardly any on correction of mild anemia in healthy adults. The objective of this intervention study was to investigate the association of vitamin E supplementation with post-supplemental blood hemoglobin levels in mildly anemic healthy Pakistani adults.
Inclusion criteria: inclusion criteria:

 mildly anemic (on the basis of screening) volunteer males and non-pregnant and non-lactating females, giving written informed consent.

 normolipidemic, normotensive

 no history of: i. diabetes, hyperlipidemia, obesity, asthma, cancer, respiratory, cardiovascular, nervous, gastrointestinal, hepatic, urogenital, musculoskeletal, endocrine, psychiatric, sexually-transmitted disease, during the last 5 years.

 ii. severe acute or chronic blood loss during last 6 months. iii. bleeding or clotting abnormality during last 1 year. iv. regular cigarette smoking, tobacco chewing v. consumption of vitamin E, vitamin B12, folate, iron or antioxidant during the last 6 months prior to enrollment.

Exclusion criteria: :

 pregnant and lactating females.

 cigarette smoking, tobacco chewing, alcohol consumers

 blood transfusions during the last 1 year

 history of diabetes mellitus, hypertension, dyslipidemia , obesity asthma, cancer, respiratory, renal, nervous, gastrointestinal, hepatic, urogenital, musculoskeletal, endocrine, psychiatric, cardiovascular disorder/disease during the last five years.

 severe acute blood loss during last 6 months.

 bleeding or clotting abnormalities during the last 1 year.

 consumed vitamin E, B12, folate, iron or antioxidants supplements during the last 6 months.


Treatment on Iatrogenic Weight Gain and Dyslipidaemia Associated With Olanzapine

Summary: Olanzapine is one of the most effective and best tolerated of the atypical antipsychotics, but it is also particularly associated with weight gain and metabolic problems.~This study is being conducted by GW Pharma Ltd as a pilot study in order to determine the efficacy and safety of two medications GW42003 and GW42004 as a 40:1 ratio when combined with the subjects existing treatment of olanzapine in subjects with weight gain attributable to olanzapine treatment for functional psychosis. This is the first study to determine whether the study medications have a positive benefit for subjects on their cholesterol levels, body weight and other metabolic parameters, as well as a potential augmentation of the anti-psychotic effect of olanzapine.~This is a multi-centre randomised, double-blind, placebo-controlled, parallel-group pilot study. There will be two groups of subjects (GWP42003 plus GWP42004 (40:1 ratio) and placebo), with a treatment duration of 6 weeks as well as a baseline period of variable length and one week follow-up. The two treatment groups will be randomised equally.~In order to be eligible for enrollment in this study, subjects will need to be aged 18 years and above and be clinically diagnosed with functional psychosis and receiving olanzapine treatment for no more than 3 months with evidence of weight gain attributable to olanzapine treatment.~Eligible subjects will enter the study at a screening visit (Visit 1) and commence a baseline period. Subjects will also be assessed at Visit 2 for further weight gain during the baseline period. The baseline period is flexible in length to allow time for this weight gain to be achieved and also for the olanzapine dose to be stabilised. If eligible the subject will be randomised into the 6-week treatment phase. There are a total of 6 visits in the study.
Inclusion criteria: inclusion criteria:

 Diagnosis (DSM-IV) of schizophrenia or functional psychosis including schizophreniform and acute psychosis with schizophrenia symptoms

 Receiving olanzapine treatment for no more than 3 months

 The dose of olanzapine is stable for at least 2 weeks prior to randomisation (Visit 2) and subject is willing to maintain a stable dose of olanzapine for the duration of the study

 Evidence of weight gain in the last 3 months attributable to olanzapine, prior to screening (Visit 1). Wherever possible, investigator must exclude other possible causes of weight gain, such as change in exercise, diet, or other illnesses

 Each subject must have further weight gain attributable to olanzapine, in the baseline period (between Visits 1 and 2) no more than 5 months subsequent to commencement of olanzapine treatment

 Willing to maintain a stable dose of any concomitant medications, and have been on a stable dose for a minimum of 6 weeks (with the exception of olanzapine)

 No changes in diet or exercise for 6 weeks prior to screening (Visit 1) and subject agrees to maintain stability, for the duration of the study (in the opinion of the investigator)

Exclusion criteria: :

 Subject has Axis I (DSM-IV) diagnosis of schizoaffective disorder;

 Subject has drug induced or toxic psychosis (in the opinion of the investigator)

 Subject presents with a clinical picture and/ or history that is consistent with delirium, dementia, amnesia or other cognitive disorder; bipolar disorder or major depression

 Subject has a significant history of anxiety, suicidal ideation or self-harm based on history or routine psychiatric status examination (in the opinion of the investigator)

 Subject has an unstable thyroid pathology (including hypo or hyperthyroidism), within the past six months (in the opinion of the investigator)

 Subject has a history of neuroleptic malignant syndrome;

 Subject requires or has had electroconvulsive therapy (ECT) treatment in the 2 month period prior to randomisation (Visit 2)

 Subject has a clinical diagnosis of diabetes

 Subject is taking insulin (i.e. they are insulin dependent) or have had insulin within 6 months prior to the screening visit (Visit 1);

 Any known or suspected history of (in the opinion of the investigator):

 alcohol or substance abuse

 epilepsy or recurrent seizures

 Any known or suspected history of depression sufficient to require treatment or disrupt ordinary life (excluding episodes of reactive depression - in the opinion of the investigator)

 BDI Score ≥ 15 (at Visit 1 or 2)

 Clinically significant cardiac, renal or hepatic impairment in the opinion of the investigator

 Genetic dyslipidaemic condition in the opinion of the investigator

 Female patients of child-bearing potential and male patients whose partner is of child-bearing potential, unless willing to ensure that they or their partner use effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (however, a male condom should not be used in conjunction with a female condom as this may not prove effective)

 Travel outside the country of residence planned during the study treatment period

 Having received olanzapine treatment continuously for more than 3 months prior to screening (Visit 1)

 Received an Investigational Medicinal Product within the 90 days before the screening visit (Visit 1)

 Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, influence the result of the study, or the subject's ability to participate in the study


Cognitive Behavioral Therapy, Self-Efficacy, and Depression in Persons With Chronic Pain

Summary: The investigators are exploring the role of Cognitive Behavioral Therapy (CBT), a treatment for depression, on self-efficacy (feeling empowered to accomplish a given task) and depression in persons with chronic pain and depression. Past research has shown that persons with chronic pain show improvement in self-efficacy and depression scores when they are using CBT. The Pain rehabilitation Center (PRC) at Mayo Clinic is adding CBT focused groups to better understand the role of CBT on self-efficacy and depression in persons with chronic pain and depression.
Inclusion criteria: inclusion criteria:

 18 and over with chronic pain and

 score of 27 or higher on CES-D scale

Exclusion criteria: :

 17 or younger, no chronic pain,

 cognitively unable to participate in programming


Lifespan Integration for Posttraumatic Stress Disorder From an Auto Accident

Summary: The purpose of this study is to evaluate if lifespan integration (LI) therapy reduces posttraumatic stress symptoms following a motor vehicle accident (MVA) trauma
Inclusion criteria: inclusion criteria:

 Involved in or witnessed a car accident at least 6 months ago.

 PTSD or distress or impairment in important areas of functioning following the car accident

Exclusion criteria: :

 moderate or severe head injury

 current mental health treatment for the MVA-related problem

 severe chronic pre-injury mental health problems

['Lifespan Integration Therapy', 'Lifespan Integration- Control']

Lifespan Integration Therapy
Lifespan Integration- Control


A Functional Food for the Prevention of Iron-deficiency Anemia

Summary: It has been estimated that 1 in 2 women expecting a baby will be diagnosed with iron deficiency. In turn iron deficiency can affect the health and wellbeing or both mother and child. Studies show that low iron stores prior to conception and low iron intakes during pregnancy may both be contributing to this problem. Although dietary supplements may be one solution, research indicates that daily compliance is low (Nguyen et al., 2008). Furthermore, prescribed iron supplements may result in uncomfortable side-effects, including constipation (Wulff & Ekstrom, 2003).~It is been observed in Ethiopia that iron deficiency anemia is lower than average; a finding that has been attributed to regular Teff consumption (Gies et al., 2003). Teff (Eragrostis tef) is a staple food usually consumed in the form of Enjera (flat bread prepared using a range of cereals). Research has shown that Teff is a rich source of iron that is easily absorbed by the body.~Although it is believed that regular Teff consumption may prevent to onset of iron deficiency anemia there is no research to support this. Therefore, the aim of the present study is to es-tablish whether incorporating Teff into the daily diet may be one way to improve blood profile and prevent the onset of iron deficiency anemia in expectant mothers. Study findings will demonstrate whether Teff may be an alternative source of iron that can be easily incorporated into the daily diet of both pregnant mothers and the lay public.
Inclusion criteria: inclusion criteria:

 Caucasian

 Primiparous

 Singleton pregnancy (wk 20 to wk 30)

 Non smokers

 Pre pregnancy BMI between 19.8 and 26

 Healthy, free from iron metabolism disorders (pregnancy induced hypertension

 Not taking medicines known to influence iron status

 Not taking iron supplements (multivitamins will be accounted for)

 Free from gastrointestinal disorders

 No allergies

Exclusion criteria: :

 Pregnancy haemoglobin concentrations are not within the normal range (below 70g/l or over 160g/l)


Pharmacokinetic Study of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin

Summary: This is an open-label, multicenter pharmacokinetic study of HD od PD patients receiving erythropoietin. Patients were administered 100mg of iron sucrose undiluted by slow IV push over 5 minutes. Patients underwent serial blood draws and were subsequently followed for 7 days for safety endpoints.
Inclusion criteria: inclusion criteria:

 Age between 12 and 18

 History of Chronic Renal Failure requiring HD or PD

 Hgb </= 13 g/dL

 Ferritin < 800 ng/ml

 TSAT < 50%

 Receiving EPO

Exclusion criteria: :

 Known Sensitivity to Iron Sucrose

 Severe Concomitant disease of the liver or cardiovascular system

 Serious bacterial Infection

 Pregnancy / Lactation

 Active Hepatitis

 Patients with Causes of iron deficiency other that Chronic Renal Failure

 Blood Transfusion

 Body Weight < 25 KG

 Currently being treated for Asthma

 Received investigational drug within last 30 days


Thyroid Disease and Personality Study

Summary: Observe the relationship between thyroid function and personality traits
Inclusion criteria: inclusion criteria:

 aged between 20 and 85 years

 euthyroid Graves' disease

Exclusion criteria: :

 Patients who were not capable to complete the questionnaire due to severe cognitive dysfunction or under education were excluded from this study


Comparison of Osteoporosis Disease Management Strategies (0000-039)

Summary: The purpose of this study is to assess the impact of disease management interventions on bone mineral density screening rates and osteoporosis treatment rates in women age 50-64 years at high risk for osteoporosis.
Inclusion criteria: inclusion criteria:

 Members of the Harvard Pilgrim Health Plan

Exclusion criteria: :

 Individuals who are not members of the Harvard Pilgrim Health Plan


Comparative Efficacy of Ovule vs Tablet

Summary: The study is focused to prove that the efficacy of a new Canesten formulation (ovule) is not inferior to the old Canesten formulation (tablet)
Inclusion criteria: inclusion criteria:

 Non-pregnant females aged at least 14 years in Germany or at least 16 years in Russia and not older than 50 years.

 Subjects presenting a symptomatic vulvovaginal yeast infection confirmed by microscopic evaluation (wet mount preparation).

 Subjects must be cooperative, able to understand the requirements of the trial participation, and willing to participate in the trial. For adolescents the informed consent has to be provided to a legal representative in addition.

 Subjects of childbearing potential must use an acceptable method of contraception. Hormonal or oral contraceptive drugs, intra-uterine devices (IUD) and abstinence are considered acceptable methods of contraception.

 Negative saline smear for Trichomonas vaginalis

Exclusion criteria: :

 Subjects with known hypersensitivity to imidazoles or triazoles and their analogues.

 Subjects presenting a protozoan infection as confirmed by microscopic investigation.

 Pregnant, breast feeding or lactating subjects.

 Subjects with suspected bacterial vaginal infection.

 Subjects with abdominal pain, fever, or foul smelling vaginal discharge.

 Subjects who had a vaginal infection, or who had used an intravaginal or systemic antimycotic treatment within 60 days prior to visit 1.

 Subjects using or wishing to use intra-vaginal or systemic anti-infectives or systemic antifungal therapy during the trial.

 Subjects wishing to use contraceptive foams, creams, jellies, sponges, therapeutic ointments, condoms, diaphragms, and OTC vaginal products during treatment and 3 days thereafter (i.e. until day 4).

 Subjects unable to refrain from the use of vaginal tampons during treatment and for 3 days thereafter (i.e. until day 4).

 Subjects unable to refrain from the use of feminine hygiene products (e.g. douches, feminine deodorant products) for 2 weeks (i.e. from visit 1 until visit 2).

 Subjects suffering from chronic/recurrent vulvovaginal mycosis, defined as 4 or more mycologically proven symptomatic episodes during the last 12 months.

 Subjects suffering from diseases (e.g. diabetes, decreased cellular immunity) or being treated with drugs (e.g. immunosuppressants, corticosteroids, anti-infectives) which may predispose them to mycological infections.

 Subjects who received another investigational drug within 30 days before visit 1.

 Unwillingness to refrain from sexual activity during 3 days thereafter.

 Actual menstruation at visit 1 or expected menstruation within 4 days after visit 1.

['Clotrimazole, vaginal ovule', 'Clotrimazole, vaginal tablet']

Clotrimazole
vaginal ovule
Clotrimazole
vaginal tablet

['Clotrimazole', 'Ovulen', 'Vulvovaginal Candidiasis']

Clotrimazole
Ovulen
Vulvovaginal Candidiasis


A Study of the Safety and Effectiveness of Doripenem in Filipino Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections

Summary: The purpose of this study is to assess the safety and effectiveness of doripenem treatment among Filipino patients with nosocomial pneumonia, complicated intra-abdominal infections, and complicated urinary tract infection.
Inclusion criteria: inclusion criteria:

 Patients who are diagnosed with nosocomial pneumonia including ventilator-associated pneumonia, complicated intra-abdominal infections or complicated urinary tract infection

 Patients who are eligible for doripenem treatment

Exclusion criteria: :

 Pregnant or lactating females

 Patients with hypersensitivity to doripenem and/or its derivatives

 Known at study entry to have an infection caused by pathogen(s) resistant to doripenem

 Patients taking probenecid

 History of severe allergies to certain antibiotics such as penicillins, cephalosporins, and carbapenems

 Severe impairment of renal function including a calculated creatinine clearance of less than 10 mL per minute, requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (less than 20 mL urine output per hour over 24 hours)

['Pneumonia, Bacterial', 'Nosocomial Infection', 'Intraabdominal Infections', 'Urinary Tract Infection']

Pneumonia
Bacterial
Nosocomial Infection
Intraabdominal Infections
Urinary Tract Infection


Changes in Heart Rhythms Associated With Antipsychotic Drug Treatment

Summary: This study is being done to look at the electrical activity of the heart. This study will help decide whether taking recordings for a 24-hour period gives more useful information than recording it for a few seconds in a doctor's office. The study will compare 24 hour electrocardiogram (ECG) results of patients taking thioridazine (Mellaril) to those of other patients taking different medications that took part in another study.
Inclusion criteria: inclusion criteria:

 Patients must be male or female, age 18-65

 Patients must have a definitive diagnosis by DSM-IV criteria of schizophrenia, bipolar or schizoaffective disorder.

 Patients can be receiving inpatient or outpatient treatment at time of enrollment.

 Patients must have been treated with (Mellaril) thioridazine, (Risperdal) risperidone or (Seroquel) quetiapine at least three months at time of enrollment.

 Patients must be able to provide written informed consent

Exclusion criteria: :

 Patients with a primary diagnosis other than schizophrenia, schizoaffective or bipolar disorder

 Patients who are currently taking other medications that have been shown to prolong the QTC, including tricyclic antidepressants, fluoroquinolones or antiarrythmics.

 Patients unable to provide written informed consent.

['Schizophrenia', 'Schizoaffective Disorder', 'Bipolar Disorder']

Schizophrenia
Schizoaffective Disorder
Bipolar Disorder


Pilot Study of Functional and Morphometric Brain Abnormalities Related to Adolescent Idiopathic Scoliosis (MOR-FO-SIA)

Summary: Adolescent idiopathic scoliosis (AIS) is a complex deformity with different curves. These different curves may be distinguished by different physiopathologic mechanisms.~Without fully convincing model of the emergence and development of AIS, their multifactorial nature seems evident. Several pathophysiological theories involving the central nervous system have been proposed: the AIS would be associated with disturbances of proprioceptive or sensory perception, and/or with integration of this information. This would result in an abnormal body image, responsible for sensorimotor asymmetry that may promote or cause the deformation.~The Main aim of this study is to find cortical and subcortical morphometric differences in the most common population of AIS (right thoracic AIS) compared to healthy adolescent control girls.~Secondary Objectives are to study the cerebral white matter of the same groups (fractional anisotropy in the main white matter tracts), and activation of sensorimotor neural networks (fMRI activation and functional brain connectivity).~Abnormalities of the studied parameters may be used as biomarkers for AIS diagnosis and classification.
Inclusion criteria: inclusion criteria:

 female

 between 14 and 16 years old

 normal neurological examination

 right handed

 informed consent

 informed consent form signed by a parent or a holder of parental authority

 affiliated to medical insurance

 negative urine pregnancy test For patients (A-STD) : right thoracic scoliosis with a Cobb angle between 20 and 40° For healthy volunteers (A-N) : no clinical scoliosis

Exclusion criteria: :

 pregnant or lactating woman

 antecedents of cranial trauma or cranial intervention, of migraine, of spinal trauma, of scoliosis intervention

 no idiopathic scoliosis

 contraindications to MRI

 patient with a legal protection measure


Prevention of Intrusive Memories and Posttraumatic Stress Symptoms After Emergency Cesarean Section

Summary: This pilot study aims to investigate the effects of a brief computerized intervention (the computer game Tetris) on intrusive memories and other posttraumatic stress symptoms following an emergency cesarean section. Patients who have undergone an emergency cesarian section will be randomly allocated to either the brief computerized intervention or usual care within the first 6 hours following the operation. Participants will be followed up at one week and one month. It is predicted that participants given the brief computerized intervention will develop fewer intrusive memories and less severe clinical symptoms than those who are not. This will inform the potential future development of a simple computerized intervention to prevent distressing psychological symptoms after a traumatic event such as an emergency cesarean section.
Inclusion criteria: inclusion criteria:

 Female, aged 18+ years

 Had emergency caesarean section within the past 6 hours

 Have given birth to a live baby at ≥ 37 weeks gestation

Exclusion criteria: :

 Do not speak French sufficiently well to participate in assessments

 Have established intellectual disability or psychotic illness

 Baby was transferred to intensive care unit after the birth

['Posttraumatic Stress Disorder', 'Acute Stress Disorder']

Posttraumatic Stress Disorder
Acute Stress Disorder


TG Gene Mutations and Congenital Hypothyroidism

Summary: The aim of this study was to identify mutations in the thyroglobulin gene that might be present in patients with fetal goiter and congenital goiter hypothyroidism.
Inclusion criteria: inclusion criteria:

 Patients with congenital hypothyroidism due to thyroglobulin defective synthesis.

Exclusion criteria: :

 Patients with another disease.


HRT Versus Etidronate for Osteoporosis and Fractures in Asthmatics Receiving Glucocorticoids.

Summary: To determine and compare the effects of Hormone replacement therapy (HRT), etidronate, HRT plus etidronate and no treatment over 5 years in the prevention and treatment of glucocorticoid-induced osteoporosis and fractures in post-menopausal women with asthma.
Inclusion criteria: inclusion criteria:

 Postmenopausal, asthmatic outpatients under 60 years of age on long-term oral or inhaled glucocorticoid treatment for at least one year.

Exclusion criteria: :

 Hysterectomy, history of breast or endometrial cancer, undiagnosed pelvic or breast mass, untreated hypertension.

['Hormone Replacement Therapy and Etidronate']


Ixabepilone in Treating Young Patients With Solid Tumors or Leukemia That Haven't Responded to Therapy

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.~PURPOSE: This phase I trial is studying the side effects and best dose of ixabepilone in treating young patients with relapsed or refractory solid tumors or leukemia.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Meets 1 of the following criteria:

 Histologically confirmed solid tumor (closed to accrual as of 10/4/2007) that relapsed after or failed to respond to front-line curative therapy and for which no other potentially curative treatment options exist

 Curative therapy may include surgery, radiotherapy, chemotherapy, or any combination of these modalities

 Eligible tumor types include, but are not limited to, the following:

 Rhabdomyosarcoma

 Other soft tissue sarcomas

 Ewing's sarcoma family of tumors

 Osteosarcoma

 Neuroblastoma

 Wilms' tumor

 Hepatic tumors

 Germ cell tumors

 Primary brain tumors

 Histologic confirmation may be waived for brain stem or optic glioma

 Diagnosis of relapsed or refractory leukemia

 Patients with refractory or second or greater relapsed leukemia must have > 25% blasts in the bone marrow (M3 bone marrow) with or without active extramedullary disease (except for leptomeningeal disease)

 Relapsed after or failed to respond to frontline curative therapy and no other potentially curative therapy (e.g., radiotherapy, chemotherapy, or any combination of these modalities) exists

 Patients with acute promyelocytic leukemia must be refractory to treatment with retinoic acid and arsenic trioxide

 Patients with Philadelphia chromosome positive chronic myelogenous leukemia must be refractory to imatinib

 No active CNS leukemia (CNS3)

 PATIENT CHARACTERISTICS:

 Age:

 2 to 18 (solid tumor patients [closed to accrual as of 10/4/2007])

 1 to 21 (leukemia patients)

 Performance status:

 For patients age 11 to 21:

 Karnofsky 50-100%

 For patients age 1 to 10:

 Lansky 50-100%

 Life expectancy:

 Not specified

 Hematopoietic:

 Platelet count at least 100,000/mm^3 (20,000/mm^3 for leukemia patients)

 Hemoglobin ≥ 8.0 g/dL

 Hepatic:

 Bilirubin less than 1.5 times upper limit of normal (ULN)

 SGOT and SGPT less than 2.5 times ULN

 No hepatic dysfunction that would preclude study

 Renal:

 Creatinine normal for age OR

 Creatinine clearance at least 60 mL/min

 No renal dysfunction that would preclude study

 Other:

 No known severe prior hypersensitivity reaction to agents containing Cremophor EL

 No clinically significant unrelated systemic illness (e.g., serious infections or other organ dysfunction) that would preclude study

 No grade 2 or greater preexisting sensory neuropathy

 More than 2 month since prior and no concurrent evidence of graft vs host disease

 Not pregnant or nursing

 Negative pregnancy test

 Fertile patients must use effective contraception

 PRIOR CONCURRENT THERAPY:

 Biologic therapy:

 Recovered from all therapy-related acute toxic effects (leukemia patients only)

 Prior epoetin alfa allowed

 At least 3 days since other prior colony-stimulating factors (e.g., filgrastim (G-CSF), sargramostim (GM-CSF), or interleukin-11 (IL-11))

 At least 6 months since prior bone marrow transplantation

 At least 2 months since prior stem cell transplantation or rescue (leukemia patients)

 At least 7 days since prior therapy with a biological agent and hematopoietic growth factor with the exception of erythropoietin

 More than 3 weeks since prior monoclonal antibody therapy (leukemia patients only)

 No concurrent GM-CSF or IL-11

 No concurrent immunotherapy

 Chemotherapy:

 See Disease Characteristics

 Recovered from all therapy-related acute toxic effects (leukemia patients only)

 At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

 No other concurrent anticancer chemotherapy

 Endocrine therapy:

 Concurrent corticosteroids allowed for the control of symptoms related to tumor-associated edema in patients with brain tumors

 Patients with brain tumors must be on a stable or tapering dose of corticosteroids for 7 days before baseline scan is performed for the purpose of assessing response to study therapy

 Must be on a stable or tapering dose of corticosteroids for 7 days prior to study entry (leukemia patients only)

 Radiotherapy:

 See Disease Characteristics

 Recovered from all therapy-related acute toxic effects (leukemia patients only)

 At least 4 weeks since prior radiotherapy

 More than 2 weeks since prior local palliative radiotherapy (leukemia patients only)

 More than 3 months since prior total-body irradiation, craniospinal radiotherapy, or radiotherapy to ≥50% of the pelvis (leukemia patients only)

 More than 6 weeks since prior other substantial bone marrow radiotherapy (leukemia patients only)

 No prior extensive radiotherapy (e.g., craniospinal irradiation, total body irradiation, or radiotherapy to more than half of the pelvis)

 No concurrent anticancer radiotherapy

 Surgery:

 See Disease Characteristics

 Other:

 Recovered from prior therapy

 At least 30 days since any prior investigational anticancer therapy

 At least 1 week since prior known inhibitors of CYP3A4, including any of the following:

 Antibiotics (i.e., clarithromycin, erythromycin, or troleandomycin)

 Anti-HIV agents (i.e, delaviridine, nelfinavir, amprenavir, ritonavir, idinavir, saquinavir, or lopinavir)

 Anti-fungals (i.e., itraconazole, ketoconazole, fluconazole [doses > 3mg/kg/day], or voriconazole)

 Anti-depressants (i.e., nefaxodone or fluovoxamine)

 Calcium channel blockers (i.e., verapamil or diltiazem)

 Anti-emetics (i.e., aprepitant [Emend®])

 Miscellaneous agents (i.e., amiodarone)

 Grapefruit juice

 No other concurrent investigational agents

 No concurrent St. John's Wort

 No concurrent known inhibitors of CYP3A4, including grapefruit juice

 Concurrent other agents inducing CYP3A4 allowed
Exclusion criteria:

['Brain and Central Nervous System Tumors', 'Childhood Germ Cell Tumor', 'Extragonadal Germ Cell Tumor', 'Kidney Cancer', 'Leukemia', 'Liver Cancer', 'Neuroblastoma', 'Ovarian Cancer', 'Sarcoma', 'Unspecified Childhood Solid Tumor, Protocol Specific']

Brain and Central Nervous System Tumors
Childhood Germ Cell Tumor
Extragonadal Germ Cell Tumor
Kidney Cancer
Leukemia
Liver Cancer
Neuroblastoma
Ovarian Cancer
Sarcoma
Unspecified Childhood Solid Tumor
Protocol Specific


Extended Duration of Oral Anticoagulant Therapy After a First Episode of Idiopathic Pulmonary Embolism: a Randomized Controlled Trial. PADIS-PE Study.

Summary: Rational: After 3 or 6 months of oral anticoagulation for an episode of acute venous thromboembolism (VTE), the risk of recurrent VTE is high (10 to 15% per year) in comparison with a low risk of recurrence if VTE was provoked by a major transient risk factor such as recent surgery (3% per year) independently of the initial presentation (deep vein thrombosis or pulmonary embolism). After a first episode of idiopathic VTE, 3 months of anticoagulation is associated with a very high risk of recurrence (27% per year); however, the benefit-risk of extended duration of anticoagulation (1 to 2 years) remains uncertain, mainly in relation with an increased risk of anticoagulant related bleeding. Therefore, the last ACCP conference group recommended 6 months of oral anticoagulant therapy after a first episode of idiopathic VTE. However, this recommendation is likely to be inadequate for at least two main reasons: (1) no studies compared 2 years to 6 months of anticoagulation after idiopathic VTE; and (2), if the frequency of recurrent VTE is similar after deep vein thrombosis and pulmonary embolism, however, the case fatality rate of recurrent VTE is higher after pulmonary embolism (12%) than after deep vein thrombosis (5%).~Objective : the main objective is to demonstrate that, after 6 months of oral anticoagulation for a first episode of idiopathic pulmonary embolism, 18 months of warfarin therapy is associated with a lower cumulative risk of recurrent VTE and major bleeding in comparison with that on 18 months of placebo. The secondary objectives are: (1) to determine the risk of recurrent VTE after 6 months of warfarin therapy and the presence or the absence of residual lung scan perfusion defect and the persistence or not of elevated D-dimer test; and (2), to determine the impact of extended duration of anticoagulation on the risk of VTE after stopping anticoagulant therapy on a follow-up of 2 years.~Method : French multicenter double blind randomized controlled trial. Inclusion and exclusion criteria and pulmonary diagnostic criteria have been defined. After completing 6 months of oral anticoagulation, a lung scan and D-dimer testing are performed; the investigators and the patients will be unaware of the results of these tests. Then, patients are randomized to receive 18 months of warfarin therapy or 18 months of placebo (the dose of placebo will be adapted according to false computer generated INR). The investigators, the radiologists and the patients are blinded of the treatment allocation. The project will be submitted to national ethical committee and written consent will be obtained from all included patients.~Required number of patients: the expected cumulative frequency of recurrent VTE and major bleeding over 18 months is 4.5% while on warfarin therapy and 16% while on placebo. For a α risk of 5% (to falsely conclude to a true difference) and a β risk of 10% (to falsely conclude to an absence of difference), 178 patients per group should be included. As 5% of patients are expected to be loss, a total of 374 patients is required.~Feasibility: about 50 patients per year are hospitalized in our department of medicine in Brest for an acute episode of idiopathic pulmonary embolism. Four additional centers will participate to the study and have a similar recruitment: HEGP (Pr Meyer, Dr Sanchez), CHU Antoine Béclère (Dr Parent, Pr Simmoneau), CHU Saint Etienne (Pr Mismetti, Pr Décousus), CHU Grenoble (Pr Pison, Pr Carpentier). The study will be coordinated by the Clinical Center of Investigation of Brest Hospital; true and false INR will be generated by the clinic of anticoagulant of Ile de France (Dr Cambus).~Clinical implications: the first consequence of the study is to demonstrate that 6 months of warfarin therapy is inadequate and should be continued for at least 18 additional months after a first episode of idiopathic pulmonary embolism. This study has also the potential to confirm or not the contribution of lung scan and D-dimer testing to appreciate the risk of recurrent VTE after stopping anticoagulant therapy. Lastly, the medical economical impact of such therapeutic management will be evaluated.
Inclusion criteria: inclusion criteria:

 Patients with a first episode of idiopathic pulmonary embolism who have been treated during 6 months (Plus 30 days or minus 15 days) using Vitamin K antagonist with a INR between 2 and 3.

Exclusion criteria: :

 Age < 18

 warfarin hypersensibility

 unwilling or unable to give written informed consent

 distal or proximal deep vein thrombosis

 Pulmonary embolism which was provoked by a reversible major risk factor

 major thrombophilia (protein C, S or antithrombin deficiency, antiphospholipids antibodies, homozygous factor V Leiden)

 previous documented episode of proximal deep vein thrombosis or pulmonary embolism

 other indication for anticoagulant therapy (e.g.:atrial fibrillation, mechanic valve)

 patient on antithrombotic agent in whom antithrombotic agent should be started again after stopping anticoagulation

 pregnancy

 women without contraception

 planned major surgery in the next 18 months

 ongoing cancer or cured cancer in less than 2 years

 serious bleeding risk (e.g.: gastric ulcer)

 platelet count less than 100 Giga/l

 Life expectancy less than 18 months


Low vs. Standard Dose CT for Appendicitis Trial

Summary: To determine whether low-dose (LD) CT is noninferior to standard-dose (SD) computed tomography (CT) as the first-line imaging test in adolescents and young adults in regard to negative appendectomy rate (NAR).
Inclusion criteria: inclusion criteria:

 Emergency department visit with suspected symptoms and signs of acute appendicitis

 Intravenous contrast-enhanced computed tomography examination requested due to suspicion of appendicitis

 Willing to provide telephone or cell phone numbers for follow-up

 Signed informed consent provided prior to study entry

Exclusion criteria: :

 Prior cross-sectional imaging tests to evaluate the presenting symptoms and signs

 Prior history of surgical removal of the appendix

['Diagnostic CT with low-dose radiation', 'Diagnostic CT with standard-dose radiation']


Pilot of Letrozole for Uterine Myomas

Summary: PLUM evaluates the drug letrozole as a treatment for uterine fibroids. This study is a randomized, blinded, placebo-controlled trial of oral letrozole among premenopausal women with symptomatic uterine fibroids. Participants will be randomly assigned in a 1:1 ratio to either oral letrozole 2.5mg/day for 6 months (Group A) or intermittent dosing with letrozole 2.5mg/day and an identical placebo capsule (Group B).
Inclusion criteria: inclusion criteria:

 ≥21 years old

 Premenopausal (at least one menses in last 3 months)

 Symptomatic fibroids (fibroids visualized on ultrasound or MRI and heavy uterine bleeding, pelvic pressure or discomfort, urinary or bowel abnormalities, dyspareunia)

 Fibroids that are ≤4 in total number or Fibroids that are ≤7 in total number if all fibroids are less than 4cm (40 mm) each

 Fibroids that are ≤7cm in maximum diameter, on screening imaging, if ≤4 fibroids in total number(fibroid is defined as any mass with radiographic characteristics of fibroid >2cm)

 Up to date in Pap smear screening and surveillance

 Endometrial biopsy (required if age>45 years with irregular bleeding) does not indicate premalignant or malignant cells

 Agree to use non-hormonal barrier method of contraception during study period if at risk for pregnancy

 Has primary care provider or gynecologist

 Agrees not to start new medications/treatments for fibroids during the study

 Able to give informed consent

Exclusion criteria: :

 Fibroids treated by surgery, radiologic procedure, or GnRH agonist or antagonist in the last 3 months

 Any submucosal fibroid ≥2cm that is >50% in uterine cavity (FIGO Type 0 or Type 1 fibroids) amenable to hysteroscopic resection

 Use of exogenous estrogen and/or progestin in the last month. (for 3 month long-acting depoprovera injection, no use in last 3 months)

 Pregnant, lactating, or planning to become pregnant in the next 6 months

 Hematocrit <27% or visit to emergency room or hospitalization for fibroid symptoms in the last 3 months (cannot be safely randomized to a placebo)

 History of osteopenia or osteoporosis

 History of hyperlipidemia

 Current liver or kidney disease

 Unable or unwilling to attend 4 study visits

 Pelvic imaging concerning for gynecologic cancer or cancer of the genitourinary or gastrointestinal system

 Does not have primary care provider or gynecologist


Reduced Contractile Reserve: a Therapeutic Target in Heart Failure With Preserved Ejection Fraction(HFpEF)

Summary: Heart failure with preserved ejection fraction (HFpEF) accounts for over 50% of heart failure cases in the United States, affecting a primarily elderly population. No treatment has been shown to affect mortality in HFpEF, which is more than 50% at five years a hospitalization. This project explores the underlying cardiovascular physiology of patients with HFpEF with the goal of identifying new therapeutic targets that would allow improved treatment of this devastating disease.
Inclusion criteria: inclusion criteria:

 Male or female; Age 18 or older.

 Left ventricular ejection fraction ≥ 50%.

 Symptomatic heart failure or appropriate comparator group criteria

 Informed consent signed by the subject

Exclusion criteria: :

 Symptoms of active ischemia.

 Moderate or severe mitral or aortic stenosis, or severe aortic insufficiency.

 Serum creatinine > 3.0 or chronic hemodialysis.

 Known chronic hepatic disease; defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels > 3.0 times the upper limit of normal as read at the local lab.

 Severe renal dysfunction, i.e. glomerular filtration rate (GFR) <30 ml/min.

 Atrial fibrillation

 Myocardial infarction within the last year

 Coronary bypass surgery within the last 6 months

 Stroke within the last 6 months

 Known aortic aneurysm

 Contra-indication to withdrawal of beta blocker or antihypertensive medications

 Resting or orthostatic hypotension (SBP < 90 mmHg)

 Any gastrointestinal disorder which would interfere with drug absorption

 Any significant valvular heart disease, including prior multiple valve replacement.

 Pericardial Disease

 Infiltrative or hypertrophic cardiomyopathy

 Cor pulmonale

 Unstable coronary disease

 Pregnancy

 Any condition which may prevent the subject from adhering to the study protocol, as determined by the investigator

 Heart Failure with Preserved Ejection Fraction

 Clinical evidence of heart failure with preserved ejection fraction, as manifest by at least 2 symptoms or signs, including dyspnea on exertion or at rest, orthopnea, jugular venous distention or hepatojugular reflux, rales or edema.

 Controlled systolic BP (< 150 mmHg on the day of study)

 Pulmonary Disease Group

 Known obstructive airways disease with objective documentation of an isolated obstructive defect by pulmonary function testing.

 No history of heart failure.

 No history of cardiovascular disease, with the exception of hypertension or hyperlipidemia

 History and physical examination free of signs and symptoms of heart failure, including elevated jugular venous pressure, hepatojugular reflux, rales or edema.

 Baseline echocardiographic examination without evidence of heart failure, including systolic dysfunction of the LV or RV, or evidence of more than mild diastolic dysfunction on non-invasive assessment.

 HTN/LVH Group

 Known history of hypertension.

 Echocardiographic evidence of left ventricular hypertrophy and diastolic dysfunction.

 No history or physical examination evidence of heart failure, including excessive dyspnea on exertion, dyspnea at rest, orthopnea, PND, jugular venous distention, hepatojugular reflux, rales or edema.

['Heart Failure With Preserved Ejection Fraction', 'Pulmonary Disease', 'Left Ventricular Hypertrophy/Hypertension']


Emergency Management of Minor Blunt Thoracic Trauma

Summary: Thoracic traumas are frequent causes of emergency department admissions and the third most common cause of death from trauma. Although emergency management of major thoracic traumas that have high mortality and morbidity were discussed and well-understood in detail in the literature, there are limited information regarding diagnosis, emergency management, treatment and follow-up after discharge of patients with minor blunt thoracic traumas.~The investigators aimed to investigate demographic data, physical examination findings, and the relationship between lung injury, emergency department final diagnosis, hospitalization, discharge and re-admission rates, effects of prescribed analgesics on pain and re-admissions of patients with a pre-diagnosis of minor blunt thoracic trauma on first admission.
Inclusion criteria: inclusion criteria:

 Glasgow Coma Scale (GCS) of 15

 stable vital signs

 admitted within the first 6 hours after injury

Exclusion criteria: :

 urgent and urgent triage category


Beta-Blocker Evaluation in Survival Trial (BEST)

Summary: To determine if addition of a beta-blocker to standard therapy in Class III and Class IV heart failure patients reduced total mortality.
Inclusion criteria: Men and women, ages 18 and over. Patients had compensated congestive heart failure due to idiopathic dilated cardiomyopathy or coronary disease with ejection fraction less than or equal to 0.35, were in the New York Heart Association functional class III or IV, and were taking an angiotensin-converting enzyme inhibitor, digitalis, and if needed, a diuretic. Patients with a specific indication for, or contraindication to, beta-blockade were excluded.
Exclusion criteria:

['Cardiovascular Diseases', 'Heart Diseases', 'Heart Failure, Congestive', 'Heart Failure']

Cardiovascular Diseases
Heart Diseases
Heart Failure
Congestive
Heart Failure


Prospective Validation of Cough, Dyspnea, and Quality of Life Questionnaires in Patients With IPF

Summary: The purpose of this study is to test cough, dyspnea (shortness of breath), and quality of life (QOL) questionnaires for their accuracy, sensitivity, and ability to reliably measure the severity of cough, breathlessness, and changes in cough and disease-related quality of life over time in Idiopathic Pulmonary Fibrosis (IPF) patients. These questionnaires have been used in other types of disease, but have not all been tested and validated in patients with cough due to IPF. Our hypothesis is that worsening of cough, dyspnea, and cough-related QOL questionnaire scores will correlate with physiologic markers of IPF severity and worsening of disease. Written, valid questionnaires measuring cough, dyspnea, and QOL are important to assess the benefit of investigational drugs under development to treat patients with IPF.
Inclusion criteria: inclusion criteria:

 Completion of informed consent.

 Adults over the age of 18.

 Diagnosis of IPF per ATS guidelines.

 Clinically stable at the time of enrollment defined as no antibiotics within the past month, with the exception of those patients currently listed for Lung Transplantation.

 No changes in immunosuppressive regimens (if applicable) over past month.

Exclusion criteria: :

 Inability to understand or complete paper and pencil questionnaires.

 Patient not planning to return to Stanford for clinic visits.

['Interstitial Lung Disease', 'Idiopathic Pulmonary Fibrosis']

Interstitial Lung Disease
Idiopathic Pulmonary Fibrosis


Study of Diagnosis and Pathophysiology of Pulmonary Embolism (APE 1 Trial)

Summary: The purpose of this study is to~investigate which method and criterion for diagnosing pulmonary embolism is the best and~determine the relationship between blood vessel constriction and clot size in patients developing heart failure
Inclusion criteria: inclusion criteria:

 Referred from clinical departments at Odense University Hospital

 Referred to the Departments of Nuclear Medicine or Radiology for diagnostic evaluation of suspected pulmonary embolism

 Referred for lung scintigraphy, spiral computer tomography, or pulmonary angiography

Exclusion criteria: :

 Age below 18

 Contrast allergy

 Pregnancy

 S-Creatinine above 200 micromol/L

 Metformin treatment

 Fibrinolytic or surgical therapy between examinations

 No informed consent

 Withdrawn consent

 Failed logistics (more than 24 hours between examinations)

 No conclusive pulmonary angiography

['Pulmonary Embolism', 'Right Heart Strain']


Multimedia Intervention in Patients With Familial Adenomatous Polyposis (FAP)

Summary: The goal of this research study is to test the first version of a website that will offer information and support for adolescents and young adults with FAP. Researchers want to see if the website will be helpful, easy to understand, and easy to use for young patients with FAP.
Inclusion criteria: Eligibility: (List All Criteria)

 inclusion criteria:

 1) Having a confirmed genetic or clinical diagnosis of FAP between the age of 13-24 at the time of recruitment to this study.

 18-21 year old with a previous cancer diagnosis.

 Able to read and speak English.

Exclusion criteria: :

 1) n/a

['Web-Based Multimedia Intervention', 'Questionnaire']

Web-Based Multimedia Intervention
Questionnaire

['Familial Adenomatous Polyposis', 'Colorectal Cancer']

Familial Adenomatous Polyposis
Colorectal Cancer


Evaluating the Interest of Interleukine-2 for Patients With Active Warm Hemolytic Anemia Resistant to Conventional Treatment

Summary: The investigators have demonstrated that the mean percentage of circulating CD8+ regulatory T (CD8 Tregs) cells is significantly higher in patients with warm hemolytic anemia (wAHAI) in remission than in controls and is correlated to hemoglobin levels. In vitro, low dose of interleukine-2 (IL2) induce the expansion of CD8 Tregs. The objective is to demonstrate that, over a 9 week treatment period; low doses of IL2 can induce the expansion of CD8Tregs in patients with active wAHAI.
Inclusion criteria: inclusion criteria:

 Adults (18 years old)

 wAHAI defined by the presence of hemolysis and positive coombs test (IgG +/-C3)

 Absence of infection or other hematologic disease

 wAHAI not responding to conventional steroids despite a dose over 10 mg

 No treatment with rituximab for a minimum of 6 months

 Signed informed consent form

Exclusion criteria: :

 Less than 18 years old

 Cold AHAI

 IL2 allergy

 Chemiotherapy or immunosuppressive treatment

 Treatment with rituximab for less than 6 months

 Neoplasia or hematologic malignancy

 Aplastic anemia

 Neutropenia ≤ 1000 mm3

 Infection

 Hepatitis B or C

 wAHAI associated with systemic lupus erythematosus depending on ACR criteria

 Cardiac insufficiency

 Hypertension

 Pulmonary insufficiency

 Liver cirrhosis

 Thrombopenia below 50000/mm3

 Drug addiction, alcohol abuse

 Psychiatric disorder

 Absence of signed informed consent


The Prevalence of Lung Cancer in Patients With Interstitial Lung Disease

Summary: The investigators will evaluate the prevalence of lung cancer associated with interstitial lung disease (ILD) and idiopathic pulmonary fibrosis (IPF) utilizing the Korean Health Insurance Review and Assessment Service (HIRA) database, spanning the period from January 2011 to December 2011. The database (HIRA-NPS-2011-0001) was based on random sampling of outpatients from whole population. Patients with ILDs, IPF, connective tissue disorder (CTD), and COPD were identified based on the International Classification of Disease-10 (ICD-10) diagnostic codes.
Inclusion criteria: inclusion criteria:

 equal to above 40 years old

Exclusion criteria: :

 none

['Lung Diseases, Interstitial', 'Lung Cancer']


The Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis

Summary: The objectives of this study are: to confirm the superiority of TAU-284 over placebo after two weeks of administration to pediatric patients with perennial allergic rhinitis and to investigate safety of TAU-284.
Inclusion criteria: inclusion criteria:

 Patients aged between 7 and 15 years

 Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria

 Patients with a mean rhinorrhea score and a mean sneezing score of at least 2 on the basis of symptoms recorded in the nasal allergy diary during the observation period etc.

Exclusion criteria: :

 Patients with vasomotor rhinitis or eosinophilic rhinitis

 Patients who have concurrent nasal disease that may affect the efficacy of TAU-284

 Patients with a history of any of the nasal surgical procedures

 Patients who have a positive result for pollen antigens which are dispersed during the study period

 Patients who have a positive result for dog dander or cat dander antigen and have a chance to touch dogs or cats.

 Patients with current or previous history of drug allergy

 Patients who concurrently have renal function abnormalities that may cause safety problems etc.


Cardiovascular Risk Markers and Response to Statins After Kawasaki Disease

Summary: The purpose of this study is to determine whether Chilean children with history of Kawasaki disease have endothelial dysfunction years after the acute phase of the disease, and if this condition can be modified by treatment with statins.
Inclusion criteria: inclusion criteria:

 History of Kawasaki disease more than 12 months before enrollment

 Present age of 8 years or older

Exclusion criteria: :

 Diabetes mellitus

 Not controlled hypertension

 Treatment with drugs thay modify endothelial function such as angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists, and calcium channel blockers

 Smokers of more than 5 cigarettes per day

 Total cholesterol higher than 250 mg/dl

 Triglycerides higher than 300mg/dl

 Chronic treatment with statins

 Chronic renal insufficiency (creatinine > 1.5 mg/dl)


Prediction and Characterization of Acute and Chronic Postoperative Pain

Summary: Despite enormous progress insufficient postoperative pain management remains a frequent problem in the early postoperative phase after surgery. Furthermore, the pain that persists after healing of the surgical wound is a large, but often unrecognized, clinical problem and it is estimated that 5-10% of those undergoing surgery will develop severe persistent pain leading to chronic disability and psychosocial distress.~Conditioned Pain Modulation (CPM), also known as the phenomenon pain-inhibits-pain, is a reduction in pain somewhere on the body in response to the application of a second painful stimulus outside the painful area. In recent years, the CPM has been identified as a psycho-physical measure with clinical relevance in characterizing the individual's ability to modulate pain and consequently the individual's disposition to acquire painful conditions.~The purpose of this study is primarily to assess the relationship between CPM efficacy and clinical postoperative pain (postoperative pain intensity, use of analgesics, the intensity of secondary hyperalgesia and allodynia, and the incidence of persistent postoperative pain) associated with minimally invasive repair of pectus excavatum. In addition, the study aims at identifying other patient- and/or surgery-related factors affecting the course of postoperative pain.~Hypothesis:~- The greater the positive difference between the experimental pressure pain threshold (kPa) measured before and after application of a second painful stimulus (Cold Pressor Test), the lower the risk of developing persistent postoperative pain.~Secondary hypotheses~The greater the positive difference between the experimental pressure pain threshold (kPa) measured before and after application of a different experimental painful stimulus (Cold Pressor Test) lower the pain intensity in the early postoperative period.~The greater the positive difference between the experimental pressure pain threshold (kPa) measured before and after application of a different experimental painful stimulus (Cold Pressor Test), the shorter duration of early postoperative pain.~The greater the positive difference between the experimental pressure pain threshold (kPa) measured before and after application of a different experimental painful stimulus (Cold Pressor Test), the lower the usage of epidural analgesia (mg / ml).~The larger the positive difference between the experimental pressure pain threshold (kPa) measured before and after application of a different experimental painful stimulus (Cold Pressor Test) the lower consumption of oral analgesics (mg / day).~Severe acute pain in the early postoperative period (postoperative days 0-3) is positively associated with the development of persistent postoperative pain (6 months postoperatively).~Presence of preoperative pain and / or high postoperative use of analgesics and / or high pain intensity during the first 6-8 weeks postoperatively predicts pain 6 months postoperatively.~The higher pain intensity and discomfort associated with brush-evoked allodynia and / or pinprick (Von Frey) secondary hyperalgesia the greater the risk for developing persistent postoperative pain (6 months postoperatively).~High levels of preoperative catastrophizing (assessed on the day of admission) is related to the severity of acute pain (rated third postoperative day) and chronic pain (assessed 6 months postoperatively), even if controlled for depression and anxiety.~The degree of preoperative positive and negative emotions (as assessed on the day of admission) is related to the degree of acute pain (rated third postoperative day) and chronic pain (assessed 6 months postoperatively) so that negative emotions are associated with high levels of pain, while positive feelings are related to low levels of pain.~The study population does not differ significantly from the normal population in terms of personality traits (emotional reactions, extraversion, openness to experience, friendliness, conscientiousness).~The study population does not experience a significant change in personality traits during the first 6 months after surgery.~The quality of life and self-esteem is lower among patients who develop persistent postoperative pain compared with pain patients.~Quality of life and self-esteem improve as a result of minimally invasive repair of pectus excavatum.
Inclusion criteria: inclusion criteria:

 Patients undergoing minimally invasive repair of pectus excavatum

 Age > 15 years old

Exclusion criteria: :

 Previous thoracic surgery interventions

 Disorders affecting the central or peripheral nervous system

 Chronic pain (pain intensity assessed by numerical rating scale > 3)

 Inability to speak and understand Danish (instructions, questionnaires)

 Inability to understand and participate in experimental pain modulation

 Psychiatric disorders (ICD-10)

 A history of frostbite in the non-dominant upper limb

 Sores or cuts on non-dominant upper limb

 Cardiovascular disease

 A history of fainting and/or seizures

 Fracture in non-dominant upper limb

 Reynaud's phenomenon

['Pain', 'Pain, Postoperative', 'Funnel Chest']


Effects of Visual Arts Training on Dementia

Summary: The study will use a randomized controlled trial to test the efficacy of two interventions (visual arts and music) for individuals with dementia, focusing on dementia of the Alzheimer's type (DAT). Interventions will be run for 10 weeks in dementia day centers and/or retirement residences. Participants will be tested before and after the intervention on a battery of cognitive, affective, and behavioural measures. They will be compared to a waitlist control group who don't receive the intervention.~The purpose of our research is twofold: treatment of symptoms and improved quality of life during disease progression in dementia. For the primary aim, the investigators are examining the potential of arts interventions on declining functions in dementia (memory, mood, and behavior) to investigate potential treatment effects. Secondly, quality of life will be measured, with the aim of looking beyond disease progression to contribute to an overall positive patient experience. Research has indicated the need for non-pharmacological treatments to be used as a first line of action against dementia symptoms and development. While, in best practice, pharmacological treatments should be used as a second-line approach.~Note: Music intervention dropped prior to study initiation.
Inclusion criteria: inclusion criteria:

 dementia

Exclusion criteria: :

 known comorbid cognitive or neurological impairments

['Visual Arts Training', 'Music Training']


Consolidation Chemotherapy/Concurrent Chemo-radiotherapy for Inoperable Stage III Non-small Cell Lung Cancer (NSCLC)

Summary: This is a pilot phase II study of histology based consolidation chemotherapy in patients with inoperable stage III Non-Small Cell Lung Cancer (NSCLC) following concurrent chemo-radiotherapy. Patients with inoperable stage III NSCLC would be treated with standard concurrent chemo-radiotherapy and subsequently those with non-squamous histology would be offered 4 cycles of consolidation pemetrexed and those with squamous histology 4 cycles of consolidation with gemcitabine.
Inclusion criteria: inclusion criteria:

 Adult patients 18 years and older with histology proven NSCLC with inoperable stage III A or IIIB disease.

 Inoperable stage III A defined by multiple and or/bulky N2 mediastinal lymph nodes on computed tomography (CT) scan such that in opinion of treating investigator, the patient was not a candidate for surgical resection.

 N2 disease must be documented by either biopsy, fluorodeoxyglucose positron emission tomography (PET), and or CT scan if nodes are more than 2 cm.

 Stage IIIB patients must have N3 or T4 status. N3 status must be documented by presence of contralateral (to the primary tumor) mediastinal lymph node or supraclavicular or scalene lymph node proven by either biopsy, fluorodeoxyglucose PET, or more than 2 cm on CT scan.

 No prior treatment for lung cancer

 ECOG Performance status of 0-1.

 Initiation of consolidation chemotherapy within 4-8 weeks of concurrent chemo-radiotherapy without progression.

 Adequate organ function

 leukocytes >3,000/mcL

 absolute neutrophil count >1,500/mcL

 platelets >100,000/mcL

 total bilirubin within normal institutional limits

 AST (SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal

 creatinine within normal institutional limits OR

 creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal

 All labs should be obtained within 14 days prior to start of study drug treatment.

 Ability to give informed consent and willingness to adhere to study protocol.

Exclusion criteria: :

 Patient who have had prior treatment for lung cancer.

 Prior history of radiation to chest.

 Known malignancy other than the current cancer.

 Uncontrolled intercurrent illness including but not limited to ongoing active infection, history of cardiac disease, e.g. uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within last six months or ventricular arrhythmias requiring medication, psychiatric illness that would impair patients ability to comply with study requirements.

 Pregnant or lactating women (any women becoming pregnant during the study will be withdrawn from the study)

 Patient with documented or symptoms of peripheral neuropathy.

 History of allergic reaction to compounds similar to the ones used in this study.

 Malignant effusions (pleural or pericardial)

 Superior sulcus (Pancoast) tumors.

 Any condition that would hamper ability to give informed consent or ability to comply with study protocol.

 HIV patients on anti-retroviral therapy are in-eligible to participate in this study because of potential interaction with the study drugs and increase susceptibility for infections during course of marrow suppressive chemotherapy and radiotherapy.

['Chemotherapy following concurrent Chemoradiotherapy']

['Stage III Non-small Cell Lung Cancer']


Targeting Oxidative Stress in Chronic Beryllium Disease

Summary: The purpose of this study is to understand if a drug called mesalamine helps to control inflammation associated with chronic beryllium disease (CBD). We hypothesize that in CBD subjects treated with prednisone, mesalamine treatment will enhance the immunosuppressive effects of prednisone, and thus reduce the immune response to beryllium.
Inclusion criteria: inclusion criteria:

 Diagnosis of chronic beryllium disease based on the criteria below:

 History of beryllium exposure, and;

 Positive blood and/or bronchoalveolar lavage Beryllium Lymphocyte Proliferation Tests (BeLPT), and;

 Biopsy-proven pathologic changes consistent with CBD-non-caseating granulomas and/or mononuclear cell interstitial infiltrates, and;

 Positive bronchoalveolar lavage (BAL) BeLPT and > 15% lymphocytes in BAL fluid.

Exclusion criteria: :

 History of Hepatic disease

 History of Renal disease

 Hypersensitivity to Pentasa (5-ASA) or salicylates.

 Pregnancy

 Presence of another disease that may be expected to significantly affect patient mortality (e.g., HIV), severe cor pulmonale);

 The use of blood thinners.

 Current use of tobacco (smoking or otherwise) in the past 6 months

 Patient inability to participate in the study, such as inability to undergo venipuncture and BAL procedures (if undergoing bronchoscopy) that form part of the inclusion/


Benefits of Medical Therapy Plus Stenting for Renal Atherosclerotic Lesions

Summary: This study will compare medical therapy plus stenting of hemodynamically significant renal artery stenoses versus medical therapy alone in patients with systolic hypertension and renal artery stenosis.
Inclusion criteria: inclusion criteria:

 Either

 Documented history of hypertension on two or more anti-hypertensive medications OR

 Renal dysfunction, defined as Stage 3 or greater chronic kidney disease (CKD) based on the new National Kidney Foundation (NKF) classifications (estimated glomerular filtration rate [GFR] less than 60 mL per minute per 1.73 m^2, calculated by the modified Modification of Diet in Renal Disease [MDRD] formula)

 One or more severe renal artery stenoses by any of the following pathways:

 a. Angiographic: greater than or equal to 60% and less than 100% by renal angiogram OR b. Duplex: systolic velocity of greater than 300 cm/sec OR c. Core Lab approved Magnetic Resonance Angiogram (MRA) (refer to the protocol for specific criteria) demonstrating stenosis greater than 80% OR stenosis greater than 70% with spin dephasing on 3D phase contrast MRA OR stenosis greater than 70% and two of the following: i. Ischemic kidney is greater than 1 cm. smaller than contralateral kidney ii. Ischemic kidney enhances less on arterial phase iii. Ischemic kidney has delayed Gd excretion iv. Ischemic kidney hyper-concentrates the urine v. 2-D phase contrast flow waveform shows delayed systolic peak vi. Post-stenotic dilatation d. Clinical index of suspicion combined with a Core Lab approved Computed Tomography Angiography (CTA) demonstrating Stenosis is greater than 80% by visual assessment on high quality CTA Stenosis is greater than 70% on CTA by visual assessment and there are two of the following i. The length of the ischemic kidney is greater than 1 cm. smaller than contralateral kidney ii. Reduced cortical thickness of ischemic kidney iii. Less cortical enhancement of ischemic kidney on arterial phase iv. Post-stenotic dilatation

Exclusion criteria: :

 Unable to provide informed consent

 Unable or willing to comply with study protocol or procedures

 Must be greater than 18 years of age

 Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis known to be present prior to randomization

 Pregnancy or unknown pregnancy status in female of childbearing potential

 Participation in any drug or device trial during the study period, unless approved by the Steering Committee

 Prior enrollment in the CORAL study

 History of stroke within 6 months, if associated with a residual neurologic deficit*

 Any major surgery, major trauma, revascularization procedure, unstable angina, or myocardial infarction 30 days prior to study entry*

 Any planned major surgery or revascularization procedure, outside of the randomly allocated renal stenting indicated by the protocol, after randomization*

 Hospitalization for heart failure within 30 days*

 Comorbid condition causing life expectancy of less than or equal to 3 years*

 Allergic reaction to intravascular contrast, not amenable to pre-treatment

 Allergy to stainless steel

 Allergy to all of the following: aspirin, clopidogrel, ticlopidine

 Known untreated aneurysm of the abdominal aorta greater than 5.0 cm.*

 Previous kidney transplant

 a. Stenosis of greater than 50% of a previously treated revascularized renal artery OR b. Treatment of any renal artery stenosis within the past 9 months (roll-in patients can have prior treatment on the contralateral side)

 Kidney size less than 7 cm. supplied by target vessel

 Hydronephrosis, nephritis or other known cause of renal insufficiency, not due to large vessel renal artery stenosis

 Visualized stenosis of only an accessory renal artery supplying greater than 1/2 of the ipsilateral renal parenchyma, without stenosis in a dominant renal artery

 Local lab serum Cr greater than 4.0 mg/dl on the day of randomization*

 Presence of a renal artery stenosis not amenable for treatment with a stent, known to be present prior to randomization

 The index lesion cannot be treated with a single stent (i.e. greater than 18 mm. in length)

 The placement of a stent will necessitate covering a renal artery branch renal artery with a stent

 The stenosis is in an artery less than 3.5 mm. in diameter

 The stenosis involves a segmental renal artery branch

 Abrupt vessel closure or dissection after diagnostic angiography [NOTE: Patients with abrupt vessel closure or dissection as a result of diagnostic angiography will not be randomized but will undergo stent revascularization, receive optimal medical therapy and will be followed for the full study period] *Roll-in patients do not need to meet these inclusion/

['Atacand/HCT, Caduet', 'GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting)']

['Atherosclerosis', 'Cardiovascular Diseases', 'Hypertension, Renovascular', 'Renal Artery Obstruction']

Atherosclerosis
Cardiovascular Diseases
Hypertension
Renovascular
Renal Artery Obstruction


Bevacizumab Plus Modified FOLFOX6 Regimen as the Salvage Treatment in Metastatic Breast Cancer (MBC) Patients

Summary: The objective of this phase II study is to evaluate efficacy and safety of avastin plus modified FOLFOX6 regimen in HER-2 negative metastatic breast cancer patients. Fifty-five patients will be enrolled into this study.
Inclusion criteria: inclusion criteria:

 age>=18years

 Eastern Cooperative Oncology Group (ECOG) performance status (PS) <=2 and a life expectancy >= 12 weeks;

 histological-proven, HER-2 negative measurable stage IV disease;

 exposure to anthracyclines, taxanes either in the neoadjuvant/adjuvant or in the metastatic setting and had documented disease progression after the firstline or secondline treatment

 Patients previously treated with radiotherapy were eligible for the study, provided that measurable disease existed outside the radiation field.

 At least 3 weeks from the prior chemotherapy or radiotherapy. At least 2 weeks from the prior endocrine therapy.

Exclusion criteria: :

 Patients with active infection or other serious underlying medical conditions

 Patients had prior treatment with 5-FU infusion and/or oxaliplatin therapy

 Inadequate bone marrow, liver, renal, medullary, and cardiac functions

 Evidence of spinal cord compression or brain metastasis

 History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer

 Pregnant or lactating women

 Serious uncontrolled intercurrent infection

 History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding

 Serious non-bleeding wound, peptic ulcer or bone fracture

 Prior dihypopyrimidine dehydrogenase deficiency

 Hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanlised antibodies


Fast Track Appendectomy for Suppurative Appendicitis

Summary: The literature has reported that fast track surgery can be safely applied to children undergoing appendectomy for acute appendicitis. There is no current evidence regarding the application of same day discharge protocol in children with intra-operative findings of suppurative appendicitis. The current standard of care for patients who present with intra-operative findings of suppurative appendicitis includes post-operative admission and treatment with intravenous antibiotics. Patients are discharged home once they have met the following discharge criteria: temperature less than 38.5 degrees Celsius, pain control with oral pain medication, and tolerating a liquid diet. Given the evidence in the literature that has shown that same day discharge of patients with acute appendicitis is safe and effective, we propose that fast track surgery protocol can be safely applied to patients with intraoperative findings of suppurative appendicitis. We hypothesize that this will result in a decreased postoperative length of stay, without an increase in 30-day complication rate.
Inclusion criteria: inclusion criteria:

 Pediatric patients aged 5-18

 Diagnosis of appendicitis and scheduled for appendectomy during the hours of 0600-1800.

 Intraoperative findings of suppurative appendicitis

Exclusion criteria: :

 Pregnancy

 Complex medical history not appropriate for same day discharge

['Patients discharged home the same day following appendectomy']