Inflammatory and Immune Profiling of Kidney Tissue Obtained From Patients With Newly Diagnosed Kidney Disease

Summary: This study will evaluate in patients with kidney disease, the role that certain inflammatory and immune mediators play in promoting kidney damage. The investigators hypothesize that certain mediators, (identified in the serum, urine and renal biopsy tissue), of patients with a variety of different renal disease states will provide information regarding their clinical course and that inflammatory and immune patterns in the serum and urine of patients with kidney disease may yield predictive diagnostic information in place of a renal biopsy. The ability to detect and quantify these mediators may lead to earlier detection and treatment of kidney disease in order to prevent kidney failure and the requirement for renal replacement.~The study will evaluate serum, blood and urine collected over a one year period post kidney biopsy for the presence of inflammatory or immune mediators, which will be correlated with kidney pathology findings (gene signatures). These gene signatures will be compared to normal control specimens obtained from donor transplant kidneys or from normal kidney tissue obtained from patients who require their entire kidney removed for a tumor.
Inclusion criteria: inclusion criteria:

 Male and females, 18 years to 90 years old

 Any subject with pre-existing clinical indication of a kidney biopsy including, but not limited to, nephritic syndrome, nephritic syndrome or proteinuric disease state. Additionally, kidney transplant donors will be included for purpose of obtaining control tissue.

 Willing and able to give consent

 Additionally, kidney transplant donors and patients requiring nephrectomy for removal of renal mass will be included for purpose of obtaining control tissue.

Exclusion criteria: :

 Subjects on longstanding immunosuppressive agents (empiric initiation of glucocorticoid therapy within 48 hours prior to kidney biopsy is acceptable)

 Kidney transplant recipient

 Inability to follow-up for future protocol laboratory evaluation

['Proteinuria', 'Kidney Injury', 'Chronic Kidney Disease']

Proteinuria
Kidney Injury
Chronic Kidney Disease


Double Blinded, Placebo-Controlled Trial of Paliperidone Addition in SRI-Resistant Obsessive-Compulsive Disorder

Summary: Obsessive-compulsive disorder (OCD) is a common, chronic, and oftentimes disabling disorder. The only established treatments for OCD are a specific form of Cognitive Behavioral Therapy (CBT) and the Serotonin Reuptake Inhibitor medications (SRIs). Few patients with OCD experience complete symptom resolution with either modality and even after two consecutive SRI trials, as many as 30%-40% of patients fail to derive a satisfactory response. Pharmacological options for these SRI-resistant cases include switching to a different antidepressant, increasing the dose of SRI, or augmentation with another agent.~Previous studies showed that approximately 33-50% of OCD patients who have not had an adequate response to SRI medication had a positive response when an atypical antipsychotic medication was added. However, the problematic acute and long-term side effects of these medications are of concern and, at times, limit their use. Paliperidone has a number of advantages over these medications including fewer drug interactions and better tolerability. Thus, this study is designed to determine whether paliperidone augmentation of an existing medication is effective relative to taking a placebo and your existing medication.
Inclusion criteria: inclusion criteria:

 Meets DSM-IV-TR criteria for a principal current diagnosis of OCD which is confirmed by both clinical evaluation and by structured interviews. OCD subjects with other comorbidities will be included provided OCD is judged to be the chief complaint.

 Subjects must continue to experience clinically significant symptoms of OCD (Y-BOCS score ≥19 and a rating of moderate or greater on the Clinical Global Impressions (CGI) scale) despite at least two adequate SRI monotherapy trials. One unsatisfactory trial can include the SRI currently being taken by the patient provided that the duration of treatment is 12 weeks or more and that the dose has been adequate. Subjects must be taking a clinically effective dose of a SRI (i.e., clomipramine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine and sertraline) for at least 12 weeks. Subjects must be on their current dose for at least 12 weeks and must maintain their current dose throughout the study.

 Between the ages of 18-70 years of age.

 Only subjects with OC symptoms of at least one-year duration will be included.

 Eligible subjects must be in good physical health. Screening procedures will include detailed medical history, complete physical and neurological exams, routine blood studies (CBC, liver function tests, electrolytes), ECG, urine toxicology screen, and serum pregnancy test in women of child-bearing potential.

Exclusion criteria: :

 Primary depression, schizophrenia or other psychotic disorders.

 Active bipolar disorder.

 Non-responder in the past to atypical antipsychotic augmentation. This criterion was chosen to prevent recruiting a sample of chronically refractory OCD cases that would otherwise be suited for more extreme interventions such as deep brain stimulation.

 Non-responder in the past to an adequate trial (> 20 hours) of cognitive-behavioral therapy that will be assessed by records review.

 Current clinically significant suicidality or individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical intervention.

 Alcohol or other significant substance abuse within the last 6 months.

 History of neurosurgery, encephalitis or significant head trauma or a significant medical condition such as heart, liver, or renal disease.

 Nursing mothers or women of childbearing potential who do not use adequate contraception will be excluded.

 Subjects at an increased risk for seizures will also be excluded from this study (e.g., subjects with a history of seizures [other than childhood febrile seizures], subjects taking concomitant medications known to lower the seizure threshold).

 Estimated IQ < 80, mental retardation, dementia, brain damage, or other cognitive impairment that would interfere with the capacity to participate in the study and complete measures. If needed, the WASI will be used to assess this at screening.

 Concurrent use of benzodiazepines, other than for treatment of insomnia, will be prohibited during the trial. No other psychotropic medications will be permitted.


Endothelial Cell Dysfunction in Pulmonary Hypertension

Summary: This study will examine and test healthy volunteers and patients with pulmonary hypertension to try to learn more about the disease and find better ways to detect, treat, and, if possible, slow progression. Pulmonary hypertension is a rare blood vessel disorder of the lung in which the pressure in the pulmonary artery (the blood vessel that leads from the heart to the lungs) rises above normal levels and may become life-threatening.~Normal volunteers and patients with pulmonary hypertension 18 years of age and older may be eligible for this study. All candidates are screened with a review of their medical records. Normal volunteers also have a medical history, electrocardiogram, echocardiogram (heart ultrasound), and pulmonary function test, in which the subject breathes in and out of a tube that measures lung volume, mechanics and function.~All participants undergo the following tests and procedures:~Echocardiogram to measure heart function and blood pressure in the lungs. A small probe held against the chest uses sound waves to obtain pictures of the heart.~Magnetic resonance imaging (MRI) to evaluate the heart's pumping action. Subjects lie on a stretcher that slides into a long, tube-shaped scanner. The machine uses a magnetic field and radio waves to obtain images of the heart.~6-minute walk to measure how far the subject can walk in 6 minutes. Subjects walk around the hospital for 6 minutes at a comfortable pace.~Exercise testing to measure the ability to exercise and the subject's oxygen levels during exercise. Subjects exercise on a bike or treadmill while the oxygen and carbon dioxide they breathe are measured using a small device placed in the mouth.~Right heart catheterization to measure pressure in the heart and lungs. A small catheter (plastic tube) is placed in an arm vein. A longer catheter called a central line is placed in a deeper vein in the neck or just below the neck, or in the leg or arm. A long, thin catheter that measures blood pressure directly is then inserted into the vein and advanced through the chambers of the heart into the lung artery to measure all the pressures in the heart and obtain blood samples.~Genetic and protein studies. DNA, RNA, and proteins from blood samples are studied for genes and proteins that might predict the development or progression of pulmonary hypertension.~In addition to the above, patients whose pulmonary hypertension was caused by a blood vessel injury undergo the tests described below. The right heart catheter inserted for the catheterization procedure remains in place to obtain measurements of the effects of nitric oxide and nitrite in the following procedures:~Inhalation of nitric oxide (a gas naturally produced by cells lining arteries) at 30-minute intervals to examine its effect on lung and heart pressures.~Inhalation of aerosolized nitrite at 5-minute intervals to measure its effects on lung and heart pressures.~Inhalation of nitric oxide for up to 24 hours to obtain multiple measurements of its effect on lung and heart pressures.~Blood draws for laboratory tests.~In patients whose pulmonary hypertension was caused by a blood vessel injury, we also plan to follow response to standard therapy. After the initiation of standard therapy, we will restudy the same parameters (excluding NO and sodium nitrite studies) in these patients at approximately 4 months, and yearly for 5 years
Inclusion criteria: ELIGIBILITY CRITERIA:

 Pilot: The pilot study will enroll two groups of individuals: 1) patients who have either IPAH or a secondary form known to have similar histopathology (PAH), and 2) age, gender, and race matched control subjects for each patient.

 Main: The main study will enroll three groups of individuals: 1) patients who have either IPAH or a secondary form known to have similar histopathology (PAH), 2) patients with PH ascribed to a nonvascular injury process, and 3) age, gender, and race matched control subjects for each PAH patient. Subjects must be at least 18 years of age and must be able to provide informed, written consent for participation in this study. There is no exclusion based on race or gender.

 inclusion criteria FOR PULMONARY ARTERIAL HYPERTENSION PATIENTS:

 The inclusion criteria for this study are as follows:

 Patients diagnosed with IPAH

 Patients diagnosed with secondary pulmonary hypertension known to have histopathology similar to the primary form or PAH. Clinical conditions causing pulmonary hypertension with histopathology similar to the primary form are listed below.

 i. Eisenmenger Syndrome

 ii. Collagen vascular disease

 iii. Liver disease with portal hypertension

 iv. Toxin induced injury (anorexic agents, rapeseed oil)

 v. HIV disease

 vi. Sickle cell disease

Exclusion criteria:  FOR PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION:

 Pregnant women (all women of childbearing age will be required to have a screening urine or blood pregnancy test)

 Age less than 18 years

 Inability to provide informed written consent for participation in the study

 Mean PA less than or equal to 25mmHg or PVR less than 3 wood units

 PCW greater than 16 mmHg unless increase accounted for by increased transpulmonary gradient greater than or equal to 10 mmHg

 Patients receiving more than 1 year of oral therapy or more than 6 months of IV therapy.

 inclusion criteria FOR PATIENTS WITH NONVASCULAR INJURY-INDUCED PULMONARY HYPERTENSION:

 The inclusion criteria are as follows:

 Patients diagnosed with pulmonary hypertension not known to have histopathology similar to the primary form. Etiologies are listed below.

 Congenital or acquired valvular or myocardial disease

 Pulmonary parasitic diseases

 Arterial hypoxemia with hypercapnea

 COPD with hypoxemia and forced expiratory volume/forced vital capacity (FEV1/FVC) greater than 2 standard deviations from normal

 Interstitial lung disease with reduced total lung capacity greater than 2 standard deviations from normal and infiltrates on chest x-ray

 Pulmonary thromboembolic disease as evidenced by lung perfusion scan or pulmonary angiogram, or intravenous drug abuse

 Pulmonary hypertension due to congenital abnormalities of the lungs, thorax and diaphragm

['Secondary Pulmonary Arterial Hypertension']


Investigation of the Biomarker Copeptin in Patients With Acute Myocardial Infarction

Summary: While troponin is not detectable until several hours after an Acute Myocardial Infarction (AMI), copeptin is expected to be elevated very early after an AMI. A combination of both markers for the diagnosis of AMI early after the event is therefore expected to be advantageous.
Inclusion criteria: inclusion criteria:

 The subject must be 18 years of age or older.

 The subject must present to the Emergency Department with symptoms consistent with acute coronary syndromes (e.g., chest discomfort/pain, squeezing/fullness in the chest, pain radiating to left or both arms, jaw pain, pain in the back/neck/stomach, shortness of breath, cold sweat, nausea/vomiting, lightheadedness).

 The subject must present to the Emergency Department within 6 hours of the onset of the most recent symptoms that prompted the subject to seek medical attention in the Emergency Department.

 The patient agrees to abide by all aspects of the protocol, including all telephone follow-up.

Exclusion criteria: :

 The patient is unable to provide consent or understand the consent form.

 The ACS symptoms are clearly not the result of ACS (i.e., penetrating wounds, crush injury, etc.)


Evaluate the Time of Pain Relief of Fast Acting Aspirin Versus Acetaminophen in Subjects Diagnosed With Sore Throat Pain

Summary: This study is to evaluate the onset of relief provided by a single, oral dose of fast release aspirin 1000 mg compared to acetaminophen 1000 mg and placebo in subjects with sore throat pain.
Inclusion criteria: inclusion criteria:

 Healthy, ambulatory, male and female subjects ≥ 18 years of age

 Presence of sore throat due to upper respiratory tract infection (URTI)

 Onset of sore throat pain within six days of the screening period

 Baseline sore throat pain intensity score ≥ 60 mm on the Sore Throat Pain Intensity Scale

 Have a score ≥ 5 on the Tonsillopharyngitis Assessment

 Female subjects of childbearing potential who are currently sexually active must be using a medically acceptable form of birth control for at least one month prior to screening (three months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Nuvaring, Depo-Provera, or double-barrier and have a negative pregnancy test at screening/treatment period. Female subjects of non-childbearing potential must be amenorrheic for at least two years or had a hysterectomy and/or bilateral oophorectomy.

 Understand the pain rating assessments

Exclusion criteria: :

 History of hypersensitivity to aspirin, salicylates, other nonsteroidal anti-inflammatory drugs, acetaminophen, opioid analgesics, and similar drugs

 Use of any cold medication (i.e. decongestants, antihistamines, expectorants, antitussives) within four hours preceding administration of the investigational product

 Use of any immediate release analgesic/antipyretic within four hours or use of any sustained release or long-acting analgesic/antipyretic within twelve hours preceding administration of the investigational product

 Consumption of alcoholic beverages, or foods and beverages containing xanthines within two hours prior to administration of the investigational product

 Use of any sore throat lozenges, sprays, cough drops, menthol-containing products within one hour preceding administration of the investigational product

 Presence of cough that causes throat discomfort

 Presence of mouth-breathing or any respiratory condition that, in the Investigator's judgment, could compromise breathing

 Evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies for which aspirin or acetaminophen is contraindicated

 Relevant concomitant disease such as medically uncontrolled asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than fifty percent obstruction

 History of gastrointestinal bleeding or perforation related to previous non-steroidal anti-inflammatory therapy.

 Current or past history of a bleeding disorder

 Self reported alcoholism or drug abuse within two years prior to screening or routine consumption of three or more alcohol containing beverages per day

 Habituation to analgesic drugs or tranquilizers (i.e., routine use of five or more times per week for greater than three weeks)

 Acute illness, local infection, or disease (other than URTI with pharyngeal infection) that can interfere with the conduct of the study

 Current use of blood thinning (anticoagulant), low dose aspirin, or steroid drug

 Has initiated treatment for depression within the past thirty days

 Females who are pregnant or lactating

['Acetylsalicylic Acid (Aspirin, BAY1019036) + placebo', 'Acetaminophen + placebo', 'Placebo']

Acetylsalicylic Acid (Aspirin
BAY1019036) + placebo
Acetaminophen + placebo
Placebo


Clinical Trial Characterizing the Bioavailability of 1-Octanol in Adults With Ethanol-responsive Essential Tremor

Summary: OVERVIEW~Essential tremor (ET) is a common movement disorder affecting 0.4% of the general population and up to 14% of people 65 years and older. Response to medications such as beta blockers and primidone may be of benefit, but are often accompanied by intolerable side effects. Response to ethanol, on the other hand, has a roughly 80% chance of significant tremor reduction, though daily use of this as a treatment has potentially serious medical, social, and legal consequences.~The leading hypothesis for ET pathophysiology is an unmasking of spontaneous oscillations originating in neurons of the inferior olive. Both ethanol and 1-octanol have been shown to reduce these spontaneous oscillations in an animal model of ET; however, 1-octanol does this at a dose much lower than that leading to intoxication, suggesting in may be useful in the treatment of essential tremor. Our initial studies with 1-octanol have shown it to be safe at dosages up to 64mg/kg without signs of intoxication, while at the same time showing benefit.~OBJECTIVE~We plan to evaluate the efficacy of different 1-octanol formulations in humans based on accelerometry and spirography. We will also evaluate drug and metabolite bioavailabilities using a high performance liquid chromatography (HPLC) detection method from plasma and urine samples.~STUDY POPULATION~We will study adult subjects with ethanol-responsive Essential Tremor (ET).~DESIGN~This study is designed as a two-phase unblinded inpatient study of adults with ET receiving weight-adjusted oral dosages of 2 different formulations of 1-octanol in a crossover fashion. Phase I of the study is designed to develop an octanol detection assay using HPLC. Four subjects will receive daily escalating dosages (1-32 mg/kg) of a single 1-octanol formulation followed by a crossover trial of both formulations at a dosage of 64 mg/kg. Phase II will study 20 subjects receiving one of the two formulations at 64 mg/kg on inpatient day 1 followed by a 24 hour period of close monitoring. The second formulation will be given on day 3 and the patient will again undergo close monitoring for 24 hours.~OUTCOME MEASURES~The primary outcome measures for the study will be efficacy based on tremor ratings from accelerometry and spirography. Secondary outcome measures will be the determination of bioavailability, pharmacodynamic and pharmacokinetic profiles of octanol #61864 and octanol #68751 and their metabolites.
Inclusion criteria: inclusion criteria:

 Patients with alcohol-responsive Essential Tremor

 Limb involvement should be a prominent feature of the Essential tremor

 Patients must be willing and able to safely stop and remain off any medications used to treat essential tremor for at least 4 half-lives

 Patients must be willing to abstain from ethanol and caffeine intake for at least 48 hours prior to starting the study hospitalization until study termination

 Patients must be willing and able to fast for periods of up to 12 hours during the study

Exclusion criteria: :

 Patients with abnormalities other than tremor on neurological exam

 Patients with active or past alcohol abuse or dependence

 Patients with acute or chronic severe medical conditions such as renal failure, hepatic failure or lung disease

 Patients taking primidone

 Patients on other acute or chronic medications that influence hepatic metabolism or central nervous system (CNS) function and cannot be temporarily discontinued for the length of the study

 Patients who do not wish to take a potentially intoxicating drug

 Patients with abnormalities on their baseline screening laboratory tests

 Women who are pregnant or lactating

 Patients younger than age 21

 The presence of cognitive impairment preventing informed consent or cooperation during the study

 People of Far East Asian or Native American descent, who may possess variant alleles of the genes for alcohol metabolism, i.e., alcohol dehydrogenase and aldehyde dehydrogenase, resulting in altered (slower) metabolism and potentially increased sensitivity to alcohols and their metabolites


Protein and RNA Expression Patterns in Predicting Response to Treatment in Patients With Lung Cancer

Summary: RATIONALE: Studying samples of tumor tissue and blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in genetic material (DNA and RNA) and may also identify protein expression patterns related to cancer. It may also help doctors predict how patients will respond to treatment.~PURPOSE: This research study evaluates changes in DNA, RNA, and proteins with the goal of predicting response to treatment in patients with lung cancer.
Inclusion criteria: inclusion criteria

 Diagnosis of suspected lung cancer or lung cancer

Exclusion criteria:

 Inability to undergo therapy

['DNA/RNA sequencing and expression levels', 'Protein expression analysis', 'Lung tumor biopsy', 'Blood sample']


Mechanism Underlying Beta-cell Failure in Obese African Americans With History of Hyperglycemic Crises

Summary: Obesity is common in African American (AA) patients with newly diagnosed diabetes who present with diabetic ketoacidosis (DKA). Despite the presentation with severe symptoms of insulinopenia and ketoacidosis, clinical and immunogenetic observations indicate that most obese AA patients with DKA have type 2 diabetes. In such patients, previous studies reveal that: a) at presentation, obese AA patients with DKA have markedly decreased pancreatic insulin secretion, lower than in obese non-DKA patients admitted with comparable hyperglycemia, but significantly greater than in lean patients with DKA; b) aggressive diabetic management results in significant improvement in beta-cell function and insulin sensitivity sufficient to allow discontinuation of insulin therapy within 3 months of follow-up. Based on these observations the researchers conclude that similar to obese patients with hyperglycemia, most obese AA with DKA have type 2 diabetes, and that although defects in both insulin secretion and insulin action are present, transient b-cell failure is the primary defect in the development of ketoacidosis.
Inclusion criteria: inclusion criteria:

 Obese African American subjects (body mass index (BMI) equal or greater than 30)

 Age 18-65

 Patients with a history of diabetic ketoacidosis as defined by the American Diabetes Association (ADA) criteria

 Patients admitted with hyperglycemia but without ketoacidosis (blood glucose greater than 400ml/dl without evidence of ketosis/ketones

 Obese nondiabetic controls (BMI >30; ruled out for diabetes with a 75g oral glucose tolerance test)

Exclusion criteria: :

 Patients with positive autoimmune markers (islet cell or glutamic acid decarboxylase (GAD) autoantibodies)

 Patients with significant medical or surgical illness, including but not limited to myocardial ischemia, congestive heart failure, chronic renal insufficiency, liver failure, and infectious processes

 Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, such as hypercortisolism, acromegaly, or hyperthyroidism

 Patients with bleeding disorders, thrombocytopenia, or abnormalities in coagulation studies

 Patients with fasting hyperglycemia (blood glucose > 120 mg/dl) after discontinuation of insulin therapy

 Pregnancy


Efficacy and Safety of Dengue Vaccine in Healthy Children

Summary: The primary objective of the study was to assess the efficacy of CYD dengue vaccine after three injections in preventing symptomatic virologically-confirmed dengue (VCD) cases, regardless of the severity, due to any of the four serotypes in children aged 4 to 11 years at the time of inclusion.~Secondary objectives included to assess:~Vaccine efficacy against severe VCD cases~Vaccine efficacy against VCD cases following at least two injections with CYD dengue vaccine~Immune response to CYD dengue vaccine~Safety profile of CYD dengue vaccine. Safety assessments include solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study period.~Other objectives included:~Vaccine efficacy against VCD cases following at least one injection with CYD dengue vaccine~Vaccine efficacy against VCD cases due to each serotype~Participants with clinical signs and symptoms for VCD
Inclusion criteria: inclusion criteria :

 Aged 4 to 11 years on the day of inclusion.

 Participant in good health, based on medical history and physical examination.

 Provision of assent form signed by the participants (for participants >= 7 years old) and informed consent form signed by the parent or another legally acceptable representative.

 Participant and parent/ legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures.

 Participant attended one of the schools involved in the trial and living in the Ratchaburi Province.

 For a female participant of child-bearing potential (girls post-menarche), avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first vaccination, until at least 4 weeks after the last vaccination.

Exclusion criteria:  :

 Febrile illness (temperature >= 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.

 For a female participant of child-bearing potential (girls post-menarche), known pregnancy or positive urine pregnancy test on the day of the first trial vaccination.

 Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.

 Planned participation in another clinical trial during the present trial period.

 Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, or long-term systemic corticosteroids therapy.

 Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.

 Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.

 Receipt of blood or blood-derived products in the past 3 months.

 Participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

 Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.

 Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.

 Planned receipt of any vaccine in the 4 weeks following the first trial vaccination.e

 Participant who plans to attend another school (outside the trial area) or move to another city in the coming 30 months.

['CYD Dengue Vaccine', 'Inactivated rabies virus vaccine', 'Placebo']

CYD Dengue Vaccine
Inactivated rabies virus vaccine
Placebo

['Dengue Virus', 'Dengue Fever', 'Dengue Hemorrhagic Fever', 'Dengue Diseases']

Dengue Virus
Dengue Fever
Dengue Hemorrhagic Fever
Dengue Diseases


Natrecor in Pulmonary Hypertension

Summary: The goal of this clinical research study is to learn if the drug nesiritide (Natrecor) is effective in lowering the pressure in your lungs.~The primary objective of this study is to establish that Nesiritide (Natrecor) is effective in reducing pulmonary hypertension (PHTN) acutely as measured by a 20% reduction in the mean pulmonary arterial (PA) pressure. The secondary objectives will include: improvement in pulmonary vascular resistance (PVR), patient symptoms, exercise tolerance, frequency of toxicity, and surgeon's willingness to proceed with operation.
Inclusion criteria: inclusion criteria:

 Ages 18 to 85 years old.

 Evidence of underlying lung disease by history and physical and/or chest x-ray and/or pulmonary function testing (PFT's).

 PHTN documented by Doppler Echocardiography ( Done with in last 30 days)

 Must be able to give an informed consent.

Exclusion criteria: :

 Patients with clinically significant hypotension (defined as a systolic blood pressure (SBP) <90).

 Active infection or sepsis as defined by fever and need for IV antibiotics.

 Creatinine greater than 3.0 mg/dl

 Significant valvular disease as a cause for the PHTN.

 Severe Thrombocytopenia (as defined by platelets less than 20,000 or INR > 1.6.

 Left Ventricle Ejection Fraction (LVEF) <40% (must be done with in the last 30 days prior to signing consent).

 Hypersensitivity to nesiritide or any of it's components.

['Nesiritide (Natrecor)', 'Right Heart Catheterization']

Nesiritide (Natrecor)
Right Heart Catheterization

['Pulmonary Hypertension', 'Cancer', 'Lung Disease', 'Cardiothoracic Surgery']

Pulmonary Hypertension
Cancer
Lung Disease
Cardiothoracic Surgery


Treatment of High Blood Pressure Using Olmesartan With Hydrochlorothiazide Compared to an ACE Inhibitor With a Calcium Channel Blocker

Summary: A comparison of 2 different combinations of high blood pressure medications to treat hypertension
Inclusion criteria: inclusion criteria:

 Greater than 18 years of age

 Patients with high blood pressure

Exclusion criteria: :

 Hypertensive encephalopathy, stroke or transient ischemic attack within the past 6 months

 History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months

 Type 1 diabetes mellitus

['Olmesartan medoxomil', 'Hydroclorothiazide', 'Benazepril', 'Amlodipine']

Olmesartan medoxomil
Hydroclorothiazide
Benazepril
Amlodipine


Thiamine Supplementation to Improve Cardiac Function in Patients With Congestive Heart Failure

Summary: Working Hypothesis: a treatment with thiamine improves functional status and heart function of patients with congestive heart failure when on a diuretic treatment.
Inclusion criteria: inclusion criteria:

 Patients with stable congestive heart failure on a prescription for diuretic drugs

Exclusion criteria: :

 Acute heart failure

 Foreseeable need for further changes in medication

 Current medication containing vitamins

 Patients with a creatinine above 250 μmol/l


Very Low Density Lipoprotein Turnover in Young and Elderly Individuals

Summary: Intrahepatic and intramyocellular lipid concentrations are elevated in elderly individuals relative to young people, despite no significant difference in fasting plasma TAG concentrations. Our general hypothesis is that the increase in intrahepatic fat with age results from reduced VLDL turnover, and therefore elderly individuals in this study will display lower VLDL turnover rates than young individuals. The aims of this study are a) to compare VLDL turnover in young and elderly individuals, and b) to compare a bolus method and a constant infusion method of assessing VLDL turnover.
Inclusion criteria: inclusion criteria:

 Age 18 to 35 years, or 60 to 75 years.

 Body mass index ≤ 27 kg•m2

 Ability to sign informed consent.

 Score of ≥26 for Mini-Mental State Exam

Exclusion criteria: :

 Diabetics (plasma glucose concentration >200 mg/dl at 2 hr after oral intake of 75 g glucose).

 Fasting plasma triacylglycerol concentration above 500 mg/dl

 Kidney disease.

 Liver disease.

 Bleeding disorders.

 Anaemia (Hb < 13 g/dl in males or < 12 g/dl in females).

 Endocrine disease (with the exception of well-regulated hypothyroidism).

 Positive hepatitis or HIV screens.

 Alcohol (CAGE questionnaire; abnormal liver enzyme values) or drug abuse (amphetamines, cocaine, opioids, marijuana).

 Lipid altering agents.

 Score of <26 for Mini-Mental State Exam


Comparison of Self Adjustment Versus Standard of Care Treatment in Subjects With Type 2 Diabetes

Summary: This trial is conducted in the United States of America (USA). This trial aims for a comparison of the safety and efficacy in subjects with type 2 diabetes using either self titration or physician guided titration according to the local standard of care.
Inclusion criteria: inclusion criteria:

 Diagnosis of type 2 diabetes HbA1C <= 12.0% within the past 12 months;

 BMI <= 45.0 kg/m2

 Initiation, addition of, change to, or continuation of basal insulin therapy with insulin detemir as deemed necessary by Investigator

Exclusion criteria: :

 Anticipated change in concomitant medication known to interfere with glucose metabolism such as systemic steroids, non-selective beta-blockers or mono amine oxidase (MAO) inhibitors.

 Proliferative retinopathy or maculopathy that has required acute treatment within the last 6 months.

 Any glucose lowering medication that is not indicated in combination with insulin, such as GLP-1 Analogues

 Known hypoglycemia unawareness or recurrent major hypoglycemia, as judged by the Investigator

['Diabetes', 'Diabetes Mellitus, Type 2']


AScVS and/ or Prazosin for Scorpion Envenomation

Summary: The data available for the efficacy of AScVS and prazosin is generated through different trials done in different clinical setting. Hence it was felt worthwhile to confirm the documented efficacy of AScVS and prazosin in terms of time taken for clinical recovery in a clinical trial. Along with this, effects of both the therapies on various biochemical parameters will be recorded and compared with. It was also felt necessary to study the effect of combination on the clinical outcome.
Inclusion criteria: inclusion criteria: (All of the following)

 Patients of both sexes, in the age range of 12-65 years

 reporting to the PHC/ hospital within 48 hours of scorpion sting and

 associated with s/s of scorpion envenomation having composite score between 5 and 21 (as computed based on the criteria below:)

 Criteria Grade Symptoms

 Sweating 0 Limited to the extremity of the sting site.

 Minimal sweating all over the body, slight nasal secretions

 Generalized sweating with rigors and cold extremities.

 Gen.profuse sweating,wetting of clothes and cold clammy skin.

 Pulse rate 0 70- 90

 91 - 100

 101 - 120 or < 70

 121 - 140 or < 60 or irreg pulse

 141 - 160

 > 160

 Respiratory rate 0 < 20

 20 - 30

 31 - 40 without crepitations

 31 - 40 with crepitations

 > 40 with crepitations

 > 40 with crepitations and cyanosis

 Blood pressure 0 120/80

 Systolic: 121 -140 and diastolic: 81 -90

 Systolic: 141 -160 and diastolic: 91-100

 Syst: 161 -180 and diast: 101-110 Or syst <100

 Syst: 181 -200 and diast: 111-120 Or syst <100

 Syst: > 200 and diast: >120 Or syst < 60

 CNS effects 0 No sensory involvement

 Minimal tingling numbness around mouth

 Tingling, numbness around mouth and giddiness

 Altered sensorium, patient roudy

 Patient semiconscious

 Patient unconscious

 Priapism 2 Slight erection 3 Strong erection

 To obtain a composite score, grades for individual criterion will be added. Maximum score: 25 and minimum score: 0

Exclusion criteria: : (Any of the following)

 Composite score less than 5 and greater than 21.

 Grade of 5 in any of the criterion

 Severe Pulmonary edema with oxygen saturation below 80%.

 Severe scorpion envenomation with reporting time more than 2 days

 Any other serious medical disease which/treatment of which may confound the results e.g. cardiac diseases, diabetes, renal diseases etc.

 Severe anaphylactic reaction to any of the study drugs

 Patient (or relative in case of child) not willing to participate

['Antiscorpion venom serum(AScVS).', 'T.Prazosin', 'AScVS + Prazosin']

Antiscorpion venom serum(AScVS).
T.Prazosin
AScVS + Prazosin


Efficacy Assessment of Three Non Pharmacological Therapies in Alzheimer's Disease

Summary: ETNA3 is a multicentric randomised clinical trial conducted in France to evaluate the impact of cognitive training, reminiscence therapy and a made-to-measure program on the progression rate of dementia.
Inclusion criteria: inclusion criteria:

 Patients in the mild to moderate stages of Alzheimer's Disease : MMSE score between 16 and 26 ; and stages 3 to 5 of the Global Deterioration Scale

 Patients over 50 years of age

 Patients with social security affiliation

Exclusion criteria: :

 Patients suffering other type of dementia

 Institutionalized patients

 Patients with psychiatric disorder

 Patients with severe pathology in the terminal stages

 Patients receiving non pharmacological therapies other than that proposed in the study

 Enrollment in a pharmacological trial in the first 6 months

['Standard intervention protocol', 'Standard intervention protocol + Cognitive training therapy', 'Standard intervention protocol + Reminiscence therapy', 'Standard intervention protocol + Made-to-measure program']


Study to Assess the Efficacy and Safety of Somatostatin in the Treatment of Acute Severe Upper Gastrointestinal Bleeding

Summary: To assess the efficacy and safety of the early administration of somatostatin in infusion during 72 hours plus 2 boluses, compared to placebo in the control of acute severe UGIB with suspicion of PUB.
Inclusion criteria: inclusion criteria:

 Male or female non-cirrhotic patients at least 18 years old suspected to bleed from PU.

 Patients with haematemesis and/or hematochezia and/or melena which have been observed by a member of a clinical team (GP, hospital physician, nurse, ...).

 Either, documented signs of hypovolemia related to the current bleeding episode Or, occurrence of symptoms of hypovolemia

Exclusion criteria: :

 Treatment of the present bleeding episode with somatostatin or its analogues, vasoactive drugs, or endoscopic therapy.

 Any treatment with PPIs (IV or per os) within the last 48 hours preceding randomisation.

 Treatment (endotherapy or pharmacotherapy) for upper gastrointestinal ulcer bleeding in the last 30 days.

 Deficient haemostasis (platelets < 40 x 109/l, international normalised ratio of the prothrombin time > 1.5 (or prothrombin time < 70%), or activated partial thromboplastin time > 40 seconds (or according to the normal ranges validated, from local lab))

 Anticoagulant therapy (vitamin K antagonists or heparin including LMW heparins)

 Terminal stage illness in which endoscopy is contraindicated


Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE)

Summary: This trial seeks to describe the effect of withdrawal from mycophenolate mofetil (MMF) on risk of clinically significant disease reactivation in quiescent SLE patients who have been on long-term MMF therapy.
Inclusion criteria: inclusion criteria:

 Able and willing to give written informed consent and comply with requirements of the study;

 Age 18 - 70 years, inclusive, at randomization;

 Diagnosis of SLE, per the American College of Rheumatology (ACR) criteria;

 m-SLEDAI score < 4 at screening visit (SLEDAI score without serologies);

 Physician Global Assessment (0-3) score of 1 or less at screening visit;

 On a stable dose of MMF (1000-3000 mg/day) for at least 12 weeks prior to randomization;

 Total duration of stable or decreasing MMF therapy must be at least:

 two years for subjects initiating MMF for renal indications (with or without concurrent extra-renal manifestations), or

 one year for subjects initiating MMF for extra-renal indications.

 If the subject is on prednisone or other corticosteroid, the following criteria must be met:

 the dose may not exceed 10 mg/day (or its equivalent) for the 12 weeks prior to randomization; however, temporary (up to 4 total days) increases, not to exceed 20mg/day, are permitted;

 the dose must be held stable for the four weeks prior to randomization (no temporary increases within 4 weeks of randomization are permitted).

 If the subject has a history of B cell depleting therapy within the past 3 years, presence of CD19 positive cells must be documented within 12 weeks prior to screening;

 On maintenance HCQ or chloroquine at a stable dose for at least 12 weeks prior to randomization.

Exclusion criteria: :

 A history of life-threatening neuropsychiatric SLE within 1 calendar year prior to randomization;

 Any of the following laboratory abnormalities at the screening visit:

 Proteinuria as defined by a spot protein/creatinine ratio > 1.0 mg/mg;

 Serum creatinine > 2.0 mg/dL;

 Transaminases > 2.5x the upper limit of normal (ULN);

 Hemoglobin < 9 g/dL, unless the subject has documented hemoglobinopathy;

 White blood count (WBC) < 2000/mm^3 (equivalent to < 2 x10^9/L);

 Neutrophils < 1000/mm^3 (equivalent to < 1 x10^9/L); or

 Platelet count < 75,000/mm^3 (equivalent to < 75 x 10^9/L).

 Prednisone > 25 mg/day (or its equivalent) within 24 weeks prior to randomization for lupus activity;

 Concomitant immunosuppressants including but not limited to azathioprine, methotrexate, 6-mercaptopurine, leflunomide, calcineurin inhibitors, anti-tumor necrosis factor agents within 12 weeks prior to randomization;

 Plasmapheresis or IV immunoglobulin within 12 weeks prior to randomization;

 Cyclophosphamide therapy within 24 weeks prior to randomization;

 Concomitant therapy with belimumab within 24 weeks prior to randomization;

 B cell depleting therapy within two calendar years of randomization;

 Experimental therapy within the 24 weeks, or five half-lives of the agent, whichever is longer, prior to randomization;

 Solid organ or stem cell transplantation;

 Identified definitive diagnosis of another autoimmune disease that may require immunosuppression for treatment, including but not limited to: rheumatoid arthritis, scleroderma, primary Sjogren's syndrome, primary vasculitis, psoriasis, multiple sclerosis, ankylosing spondylitis, and inflammatory bowel disease.

 Chronic infections including, but not limited to, human immunodeficiency virus (HIV), active tuberculosis (TB), currently receiving therapy)), hepatitis B or hepatitis C, or latent systemic fungal infection;

 At or within 12 weeks of screening:

 a history of or current positive purified protein derivative (PPD) (> 5 mm induration regardless of prior Bacillus Calmette-Guérin (BCG) vaccine administration) or positive QuantiFERON unless documentation exists of completion of at least one month of prophylaxis for latent TB or completed treatment for active TB; or

 an indeterminate QuantiFERON® unless followed by a subsequent negative PPD or negative QuantiFERON.

 History of malignancy within the last five years, except for resected basal or squamous cell carcinoma, treated cervical dysplasia, or treated in situ cervical cancer Grade I;

 Pregnant or lactating, or intention to pursue pregnancy within three months after the completion of the study;

 Unable or unwilling to use reliable methods of contraception, as outlined in the Mycophenolate REMS (e.g., Risk Evaluation and Mitigation Strategy), from four weeks prior to randomization to 6 weeks after completion of the study. This criterion applies to females of reproductive potential. (Reference: Mycophenolate REMS, Program Resources and Educational Materials, Information for Patients, What are my birth control options? Access the link at: (https://www.mycophenolaterems.com/PatientOverview.aspx).

 Drug or alcohol abuse within one calendar year of randomization;

 Other medical or psychiatric conditions that the investigator feels would place the subject at special risk by participation in this protocol.

['Mycophenolate Mofetil', 'Hydroxychloroquine or Chloroquine', 'Prednisone']

Mycophenolate Mofetil
Hydroxychloroquine or Chloroquine
Prednisone


Safety Evaluation of ExAblate MRgFUS for Prostate Cancer

Summary: Evaluate the safety, compatibility and imaging quality of the ExAblate MRgFUS system.
Inclusion criteria: inclusion criteria:

 Age of patients: up to 75 years.

 Men scheduled for radical prostatectomy due to prostate cancer.

 Patients who are able and willing to give consent and able to attend all study visits.

Exclusion criteria: :

 Contraindications to MRI including: claustrophobia, weight over 120 kg, implanted ferromagnetic materials or foreign objects, and known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist)

 Severely abnormal coagulation (INR>1.5)

 Patients with unstable cardiac status including: unstable angina pectoris on medication, patients with documented myocardial infarction within six months of protocol entry, congestive heart failure requiring medication (other than diuretic), patients on anti-arrhythmic drugs, severe hypertension (diastolic BP > 100 on medication), and patients with cardiac pacemakers

 Severe cerebrovascular disease (multiple CVA or CVA within 6 months)

 Individuals who are not able or willing to tolerate the required prolonged stationary supine position during imaging (approximately 1 hrs.)

 Any rectal pathology preventing probe insertion, (as active proctitis, ulcerative colitis, fissure ani, diverticulitis, previous rectal surgery, IBD, etc…)

 Any spinal pathology that prohibits maintaining supine position for more then an hour

 Any previous radiation to the pelvis.


Incidence and Outcomes of Venous Thromboembolism

Summary: To identify the incidence cohort of Olmsted County Minnesota residents with deep venous thrombosis (DVT)/pulmonary embolism (PE) from 1966 through 1990. Episodes of DVT or PE acquired during hospitalization or in the community were identified for future studies.
Inclusion criteria: No eligibility criteria
Exclusion criteria:

['Cardiovascular Diseases', 'Lung Diseases', 'Pulmonary Embolism', 'Venous Thromboembolism']

Cardiovascular Diseases
Lung Diseases
Pulmonary Embolism
Venous Thromboembolism


S0819: Carboplatin and Paclitaxel With or Without Bevacizumab and/or Cetuximab in Treating Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer

Summary: This randomized phase III trial studies carboplatin and paclitaxel to compare how well they work with or without bevacizumab and/or cetuximab in treating patients with stage IV or non-small cell lung cancer that has returned after a period of improvement (recurrent). Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may prevent the growth of new blood vessels that tumor needs to grow. Cetuximab may also stop cancer cells from growing by binding and interfering with a protein on the surface of the tumor cell that is needed for tumor growth. It is not yet known whether giving carboplatin and paclitaxel are more effective with or without bevacizumab and/or cetuximab in treating patients with non-small cell lung cancer.
Inclusion criteria: inclusion criteria:

 Patients must have histologically or cytologically proven primary non-small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous or unspecified); disease must be stage IV; disease may be either newly diagnosed or recurrent after previous surgery and/or irradiation; patients with additional lesions in an ipsilateral non-primary lobe without M1a or M1b disease will not be considered to have stage IV disease and are not eligible

 Patients must have a computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to registration; patient must not have brain metastases unless: (1) metastases have been treated and have remained controlled for at least two weeks following treatment, AND (2) patient has no residual neurological dysfunction off corticosteroids for at least 1 day

 Patients may have measurable or non-measurable disease documented by CT or MRI; the CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality; measurable disease must be assessed within 28 days prior to registration; pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease; non-measurable disease must be assessed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form

 Patients must have tumor tissue available for submission that is sufficient for EGFR FISH testing and must agree to submission of these specimens; patients must also agree to submission of specimens for other translational medicine studies; patient must be offered participation in banking for future research

 Patients must not have received prior chemotherapy for any stage non-small cell lung cancer; patients must not have received prior platinum-based chemotherapy for any purpose; patient must not have received any cetuximab, gefitinib, erlotinib, or other investigational agents that target the EGFR pathway; patients must not have received for any purpose prior bevacizumab or other vascular endothelial growth factor (VEGF)-related agents; patients must not have received for any purpose prior chimerized or murine monoclonal antibody therapy or have documented presence of human anti-mouse antibodies (HAMA)

 Prior radiation is permitted; however, patients must have recovered from all associated toxicities at time of registration; in order to qualify as measurable, measurable disease must be outside the previous radiation field or must have progressed

 Time from surgical or biopsy procedures is dependent on whether it is planned for the patient to receive bevacizumab

 For patients who are bevacizumab-appropriate AND bevacizumab is planned: at least 28 days must have elapsed since major surgery (i.e. thoracotomy or video-assisted thoracoscopic surgery [VATS] resection of lung cancer, open pleural biopsy or another major surgical procedure such as abdominal surgery) or significant traumatic injury; patients must have recovered from all associated toxicities at the time of registration; there must be no anticipation of need for major surgical procedures during protocol treatment; patients must not have had a core biopsy, mediastinoscopy, pleurodesis, VATS pleural biopsy or VATS pericardial window within 14 days prior to registration; patients must not have had a percutaneous fine needle aspiration (FNA), thoracentesis or central venous access device implanted within 7 days prior to registration; for other surgical procedures not listed here, please contact the study coordinators

 For patients who are bevacizumab-inappropriate or bevacizumab is not planned: at least 28 days must have elapsed since major surgery (i.e. thoracotomy or VATS resection of lung cancer, open pleural biopsy or another major surgical procedure such as abdominal surgery) or significant traumatic injury; patients must have recovered from all associated toxicities at the time of registration; there must be no anticipation of need for major surgical procedures during protocol treatment; patients must not have had a core biopsy, mediastinoscopy, pleurodesis, VATS pleural biopsy or VATS pericardial window within 7 days prior to registration; patients must not have had a percutaneous fine needle aspiration (FNA), or thoracentesis within 1 day prior to registration; patients may have had a central venous access device placed at any time prior to registration; for other surgical procedures not listed here, please contact the study coordinators

 Absolute neutrophil count (ANC) >= 1,500/mcl

 Platelet count >= 100,000/mcl

 Hemoglobin >= 9 g/dL

 Serum creatinine =< institutional upper limit of normal (IULN) AND calculated or measured creatinine clearance >= 50 cc/min using the following Cockroft-Gault formula

 For patients who will be receiving bevacizumab, urine protein must be screened by urine analysis for urine protein creatinine (UPC) ratio; for UPC ratio > 0.5, 24-hour urine protein must be obtained and the level must be < 1,000 mg for patient enrollment; the urine protein used to calculate the UPC ratio must be obtained within 14 days prior to registration; UPC or 24-hour protein is not required for patients who will not receive bevacizumab Note: UPC ratio of spot urine is an estimation of the 24-hour urine protein excretion - a UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 gm

 Serum bilirubin =< 2 times IULN (for patients with liver metastases, bilirubin must be =< 5 X IULN)

 Serum glutamic oxaloacetic transaminase (SGOT) OR serum glutamate pyruvate transaminase (SGPT) =< 2 times IULN (for patients with liver metastases, either SGOT or SGPT must be =< 5 X IULN)

 Zubrod performance status 0-1

 Patients must not have >= grade 2 symptomatic neuropathy-sensory (National Cancer Institute [NCI] Common Terminology Criteria version 3.0)

 Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection

 Patients must not have the following: history (within past 6 months) of cerebrovascular accident (CVA), myocardial infarction or unstable angina; or at the time of registration, uncontrolled hypertension, New York Heart Association grade 2 or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or clinically significant peripheral vascular disease

 Patients must have no known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies (examples include trastuzumab [Herceptin] and epoetin alpha)

 Patients must be willing to provide prior smoking history

 No other prior malignancy is allowed except for any of the following:

 Adequately treated basal cell or squamous cell skin cancer

 In situ cervical cancer

 Adequately treated stage I or II cancer from which the patient is currently in complete remission

 Any other cancer from which the patient has been disease-free for 5 years

 Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of reproductive potential if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, effective contraception also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures

 Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

 As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Exclusion criteria:

['Bevacizumab', 'Carboplatin', 'Cetuximab', 'Laboratory Biomarker Analysis', 'Paclitaxel']

Bevacizumab
Carboplatin
Cetuximab
Laboratory Biomarker Analysis
Paclitaxel

['Recurrent Large Cell Lung Carcinoma', 'Recurrent Lung Adenocarcinoma', 'Recurrent Squamous Cell Lung Carcinoma', 'Stage IV Large Cell Lung Carcinoma', 'Stage IV Lung Adenocarcinoma', 'Stage IV Squamous Cell Lung Carcinoma']

Recurrent Large Cell Lung Carcinoma
Recurrent Lung Adenocarcinoma
Recurrent Squamous Cell Lung Carcinoma
Stage IV Large Cell Lung Carcinoma
Stage IV Lung Adenocarcinoma
Stage IV Squamous Cell Lung Carcinoma


Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism

Summary: The purpose of this study is to see if giving growth hormone and Lupron along with thyroid hormone will improve final height in patients with long term hypothyroidism. Lupron is a medicine which is used to delay puberty and to prevent early closure of growing bones which might increase growth potential. Growth hormone is used to restore growth rate. This study will include children with short term and long term hypothyroidism.
Inclusion criteria: inclusion criteria:

 Patients should have clinical and biochemical evidence of hypothyroidism, T4 less than 5.0 ng /dl , fT4 less than 1.0 mcg/dl and TSH of more than 10. Patients with prolonged hypothyroidism should have growth failure and delayed bone age of at least 2 SD from the mean. Patients with short term hypothyroidism should have normal growth velocity and bone age.

 Females 8 to 16 years old.

 Males 9 to 17 years old.

 Patients without any chronic medical conditions.

 Availability of a parent or guardian to attend study visits with the patient and to be actively involved in the patient treatment plan.

 Give written informed consent prior to any study specific screening procedure with the understanding that the patient has the right to withdraw from the study at any time without penalty.

Exclusion criteria: :

 Taking medications that affect their growth. (eg. Systemic corticosteroids, anabolic steroids)

 Experiencing other health problems/conditions that affect their growth rate such as growth hormone deficiency, Cushing Syndrome, rickets, and chronic diseases.

 Patients with any condition that is a contraindication for GH therapy would include conditions such as an active tumor, impaired glucose tolerance, neurofibromatosis (worsening of neurofibromatosis), and hypertrophy of tonsils and adenoids with sleep apnea. Contraindications for patients for GNRHa therapy would include a severe systemic reaction to GNRHa which is rare, osteopenia, and osteoporosis, because delaying puberty will worsen the condition.

 Moving to a location that the patient will not be able to be followed by a pediatric endocrinologist.

 Patient is not willing to continue with the study. -

['Growth hormone', 'Growth hormone treatment and puberty']

Growth hormone
Growth hormone treatment and puberty


Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses

Summary: The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of colorectal, coloanal and ileoanal anastomoses reinforced with a bioabsorbable staple line reinforcement material compared with standard non-reinforced colorectal, coloanal and ileoanal techniques with respect to the incidence of postoperative anastomotic leakage, anastomotic stricture and time to ileostomy closure, if applicable.
Inclusion criteria: inclusion criteria:

 Subjects who will undergo restorative proctectomy or proctocolectomy (<10 cm from anal verge) with a low circular stapled colorectal, coloanal or ileoanal anastomosis with or without reservoir, including treatment for rectal cancer, ulcerative colitis, familial adenomatous polyposis

 , diverticulitis, perforation of the bowel/trauma.

 Subjects undergoing Hartmann's reversal with restorative proctectomy (<10 cm from the anal verge).

 Subjects may or may not have a diverting loop ileostomy as a component of their initial surgery.

 Subjects who meet the requirements of number 1 and 2, and are being treated for rectal cancer may or may not have preoperative chemoradiation therapy in the treatment of their rectal cancer.

Exclusion criteria: :

 Subjects being treated for rectal cancer with a diagnosis of inflammatory bowel disease.

 Subjects who have significant intraoperative hypotension or cardiac events.

 Subjects with collagen vascular disease, coagulopathy, significant renal or hepatic dysfunction (creatinine >1.6 or liver enzymes > 50% upper limit of normal values).

['GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement', 'Staple line without reinforcement']

['Rectal Cancer', 'Ulcerative Colitis', 'Familial Adenomatous Polyposis', 'Diverticulitis']

Rectal Cancer
Ulcerative Colitis
Familial Adenomatous Polyposis
Diverticulitis


Anti-hypertensive Effect of Mycelia of Antrodia Cinnamomea

Summary: This the first report undertaken to assess the effect of supplementation with oral gamma-aminobutyric acid (GABA), adenosine and antrosterol-containing AC mycelia on blood pressure among people with mild hypertension. Overall, AC mycelia consumption for 8 weeks could successfully reduce mean diastolic and systolic BP through the suppression of PRA that is linked to downstream suppresion of angiotensin II formation, which further decreases the sympathetic outflow that leads to hypertension. In addition to blood pressure lowering properties, AC mycelia also has beneficial effect in reducing oxidative stress, significantly. No adverse events were noted, suggesting that AC mycelia deserve its consideration as a candidate for safe alternative treatment to conventional anti-hypertensive medications.
Inclusion criteria: inclusion criteria:

 Eligible subjects were untreated hypertensive men or women aged between 20 and 80 years old with SBP between 130 and 179 mmHg and/or DBP between 85 and 109 mmHg as measured in a sitting position

Exclusion criteria: :

 Subjects were excluded if they had a history of major cardiovascular disease, severe liver dysfunction, insulin-dependent diabetes mellitus or stroke. They were also excluded if they routinely consumed alcohol, were pregnant or unable to comprehend study instructions.


Intensive Monitoring of Brain Injured Patients

Summary: Analysis of cerebral blood flow (CBF) and oxygenation using complementary focal and global monitoring techniques will permit the delivery of more informed individualised and 'targeted' therapy on the patient with severe head injury, reduce episodes of secondary brain injury and therefore improve outcomes.~Aims~To develop a deeper understanding of Cerebral Blood Flow and auto-regulation for TBI patients based on the results of data collected in patients post TBI.~To establish the basis for further multi modality clinical trials in severely brain injured patients in the future.~To improve understanding of the various secondary processes that continue to cause neuronal damage after the initial injury, and therefore affect patient outcome.~To proceed to the second phase of the study, with the introduction of algorithms for treatment.
Inclusion criteria: inclusion criteria:

 Traumatic Brain Injury with a Glascow Coma Score < 9 (ie: severe head injury)

 Traumatic Brain Injury with a Glascow Coma Score > 8 with an intracranial pressure monitor in situ and CTscan evidence of one or more of the following: Cerebral oedema (Marshall grades III & IV), midline shift >5 mm cerebral contusion >3cm, evacuated subdural haematoma

 Enrolled within the first 48 hours after trauma

 Aged 17- 70years

Exclusion criteria: :

 Has had a cardiac arrest at or post the trauma scene

 Pupils are fixed bilaterally and dilated >4mm,GCS=3

 Coagulopathy sufficient to contraindicate surgery

 No chance of survival after consideration of CT and clinical findings

 Patients with lower limb/pelvic trauma excluded from Innercool monitoring only

['Brain oxygenation and microdialysis catheters']


Zimmer POLAR - Total Knee Arthroplasty (TKA)

Summary: The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants used in total knee arthroplasty. The assessment will include implant survivorship and clinical performance measured by pain and function, quality of life data, radiographic parameters and survivorship.
Inclusion criteria: inclusion criteria:

 Patient 18-75 years of age, inclusive;

 Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:

 rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis;

 collagen disorders and/or avascular necrosis of the femoral condyle;

 post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;

 moderate valgus, varus, or flexion deformities;

 the salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee;

 Patient has participated in a study-related Informed Consent process;

 Patient is willing and able to complete scheduled study procedures and follow-up evaluations;

 Independent of study participation, patient is a candidate for commercially available Persona fixed bearing knee components implanted in accordance with product labeling.

Exclusion criteria: :

 Patient is currently participating in any other surgical intervention studies or pain management studies;

 Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint;

 Insufficient bone stock on femoral or tibial surfaces;

 Skeletal immaturity;

 Neuropathic arthropathy;

 Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb;

 Stable, painless arthrodesis in a satisfactory functional position;

 Severe instability secondary to the absence of collateral ligament integrity;

 Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin;

 Patient has a known or suspected sensitivity or allergy to one or more of the implant materials;

 Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.);

 Patient has previously received partial or total knee arthroplasty for the ipsilateral knee.

['Polyarthritis', 'Osteoarthritis', 'RheumatoId Arthritis', 'Traumatic Arthritis']

Polyarthritis
Osteoarthritis
RheumatoId Arthritis
Traumatic Arthritis


Incidence, Severity and Treatment of Delirium in Cardiac Surgery Patients: A Before-after Study

Summary: Delirium is a common yet under diagnosed condition in hospitalized patients, and the incidence have not previously been described in Danish cardiac surgery patients. The present study seeks to describe the incidence and duration of delirium in this group of patients, before and after the introduction of standardized screening tool and a guideline for treatment of delirium after cardiac surgery.
Inclusion criteria: inclusion criteria:

 adult patients admitted for cardiac surgery at department of cardiothoracic surgery, Rigshospitalet, denmark

Exclusion criteria: :

 patients under age 18,

 patients that died within 24 hours after admission.

['systematic screening and treatment of delirium']


Delirium in Elderly Undergoing Cardiac Surgery and the Significance of CholinEsterase Activity

Summary: The purpose of this study is to assess the association between the point-of-care (POC) measured ChE activity (Acetylcholinesterase (ChE) + Buturylcholinesterase (ChE)) and postoperative delirium in elderly patients undergoing cardiac surgery.~Furthermore the investigators aim to identify factors, which influence the baseline levels and the time course of ChE activity.
Inclusion criteria: inclusion criteria:

 Written informed consent

 ≥ 65 years of age

 Scheduled to undergo elective cardiac surgery (coronary artery bypass graft (CABG), valve surgery, combined CABG-valve surgery) with the use of CPB

 Both genders

Exclusion criteria: :

 Planned deep hypothermic arrest

 Acute / emergency procedures

 Surgery without extracorporeal circulation (ECC)

 Patients with a history of pseudocholinesterase deficiency

 Employees of the respective study centres

 Illiteracy

 Severe communication difficulties and severe vision or hearing problems

 Patients legally unable to give written informed consent

 non-fluency in German language

 Severe psychiatric or neuropsychiatric disorders

 MMSE < 24 points, short geriatric depression scale (GDS) ≥ 10 points

 Recent (<6 months) history of alcohol or drug abuse

 The participation in a drug or device trial within the previous 30 days


The Use of a Non-absorbable Marker for the Evaluation of the Gastrointestinal Transit

Summary: Aim of the study The aim of this study is to use Gabbroral® oral tablet formulation as marker for the evaluation of the gastrointestinal transit. By collecting and analyzing both gastric and intestinal fluids on different time points, the transfer dissolution can be distracted. For this study stomach fluid and intestinal fluid will be collected after oral intake of a commercially available dosing form of Paromomycin Sulfate (Gabbroral® oral tablet formulation), which is dissolved in a glas of 240mL water, in fasted or fed state. Four intake conditions will be tested on four different test days (with an intermediate period of at least 7 days).~intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of 240mL water, in fasted state.~intake of Gabbroral® oral tablet formulation in fed state.~Intake of 2 tablets of Motilium® (API: domperidone 10 mg) 20 minutes before the intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of 240mL water.~Intake of 2 tablets of Motilium® (API: loperamide HCl 2 mg) 20 minutes before the intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of 240mL water.~Conduct of the study~The study consists of four testing days in the University Hospitals Leuven, Gasthuisberg campus.~On each test day you come at the agreed time in fasting State to the Gastroenterology Department at UZ Leuven (Gasthuisberg, floor 0, Orange arrow). Fasted state means that you have eaten nothing for 12 hours for the investigation and only have been drinking water.~A basic clinical anamnesis will be taken by a doctor to make sure that you are a healthy volunteer for our study. For making sure that you are HIV negative, you will undergo an HIV test. In case of a female volunteer, a pregnancy test will be taken in account to make sure you are not pregnant.~Upon arrival at the hospital through the nose or the mouth two probes: one in the stomach and one in the gut. The position of both probes is controlled using fluoroscopy (x-ray).~After a stabilisation period of ca. 20 min you will be asked for taking a single dose of Gabbroral® oral tablet formulation. On four different test days, with an intermediate period of at least 7 days, we will follow every one of following intake conditions:~intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of 240mL water, in fasted state.~intake of Gabbroral® oral tablet formulation in fed state.~Intake of 2 tablets of Motilium® (API: domperidone 10 mg) 20 minutes before the intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of 240mL water.~Intake of 2 tablets of Motilium® (API: loperamide HCl 2 mg) 20 minutes before the intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of 240mL water.~After intake of the medicine at regular intervals, gastrointestinal fluids will be aspirated over 4 hours. You sit in a comfortable position in bed; eating and sleeping is not permitted (after 2 hours you have the possibility to drink some water).~After 4 hours, the gastrointestinal catheters will be removed and you may eat and roam freely.
Inclusion criteria: inclusion criteria:

 Healthy volunteers

 age: 20-35 year

Exclusion criteria: :

 Diseases

 Acute/chronic gastrointestinal disorders

 Medication use

 Possible pregnancy

 Frequent exposure to x-ray radiation during the past year

 HIV positive

['Paromomycin Sulfate Fasted State', 'Paromomycin Sulfate Fed State', 'Paromomycin Sulfate w/ domperidone', 'Paromomycin Sulfate w/ loperamide HCl']

Paromomycin Sulfate Fasted State
Paromomycin Sulfate Fed State
Paromomycin Sulfate w/ domperidone
Paromomycin Sulfate w/ loperamide HCl

['Concentration-Time Profiles in Stomach & Intestine.']


Detection of Celiac Disease in Patients With Hypothyroidism

Summary: The study evaluates whether hypothyroid patients requiring elevated doses of levothyroxine to maintain a euthyroid state are at increased risk of having celiac disease. It also attempts to determine if there is a threshold level of levothyroxine needed to maintain a euthyroid state in patients with hypothyroidism that should prompt serologic testing for celiac disease.
Inclusion criteria: inclusion criteria:

 Patients with the diagnosis of hypothyroidism that require thyroid replacement therapy.

Exclusion criteria: :

 Surgical resection of thyroid tissue, neck irradiation, radioactive iodine therapy, prior medical treatment with lithium, methimazole, propylthiouracil, ethionamide, amiodarone, or sunitinib, prior serologic testing for celiac disease.

['Celiac Disease', 'Hypothyroidism', 'Celiac Sprue', 'Malabsorption']

Celiac Disease
Hypothyroidism
Celiac Sprue
Malabsorption


Clinical and Radiographic Outcomes of the Corin Tri-Fit Total Hip Replacement

Summary: The study will evaluate the radiographs (x-rays) of 100 patients with a TriFIT total hip at 2 weeks, 3 months, 6 months, 12 months, and yearly following surgery to see if there has been any movement or wear in the hip stem over the course of the study. The study will also record clinical data on each patient using various functional tests and questionnaires at the same intervals.
Inclusion criteria: inclusion criteria:

 Patients scheduled for primary, unilateral total hip replacement (THR) with no previous history of hip replacement and/or fracture surgery.

 Patients with arthritis secondary Noninflammatory Degenerative Joint Diseases (NIDJD), including osteo/degenerative arthritis, congenital hip dysplasia, and avascular necrosis.

 Patients who do not meet any of the
Exclusion criteria: .

['Osteoarthritis of Hip', 'Congenital Hip Dysplasia', 'Avascular Necrosis']

Osteoarthritis of Hip
Congenital Hip Dysplasia
Avascular Necrosis


Use of High Fidelity Simulation in Cardiac-specific Anesthesia Scenarios for Resident Education and Assessment

Summary: High fidelity simulations provide a unique opportunity for teaching and evaluation of knowledge, clinical reasoning, decision making and teamwork. We have developed a series of novel cardiac based simulations that review difficult learning objectives of cardiac anesthesiology rotation. We hypothesized that residents who have completed a rotation in cardiac anesthesiology will perceive these simulations to be both mentally challenging and a useful tool in preparing them for their subsequent clinical experience and for their anesthesiology board. For the first time, we have used the NASA Task Load Index Scale in evaluating Neuro Cognitive Workload during Cardiac Anesthesia Based simulation scenarios .Residents who have completed the cardiac rotation at least once would be assigned the task in small groups either a group of 2 or group of 3.The module consists of 3 different scenarios. The scenarios include, weaning the patient off of cardio pulmonary bypass, management of severe protamine drug reaction and acute hypotension from malfunction of the coronary graft in a simulated operating room in real time.~Setting up a Simulation Lab,almost similar to real cardiac operating rooms would have cardio-pulmonary bypass machine,transesophageal echocardiography images upon request,all emergency medications with various infusions pumps,defibrillator,real time monitors include EKG,SpO2,invasive arterial line,CVP,PAP,ETCO2,operating room surgical equipment,anesthesia machine with ventilator.~Tasks Assigned to the residents~Feed-back and Teaching Session~At the end of each session residents are encouraged to reflect upon how they performed and learning gaps that they perceived and areas that they felt needed to improve upon.~Feedback session would be followed by interactive teaching to reinforce the knowledge.~Evaluation of Hypothesis using NASA TLX Scale. Immediately following the Simulation based training, residents would be given the paper based NASA TLX scale to assess the neurocognitive workload
Inclusion criteria: inclusion criteria:

 Resident physicians who have completed at least one month of cardiac rotation are included.This high fidelity simulation lab course if offerred to every resident that meets the criteria.This is a part of their educational activity.At the beginning of the course they are given the option to participate in the survey.If they do not wish to participate in the survey it will not affect their education.Participitaion in the survey is purely voluntary.

Exclusion criteria: :

 Resident physicians that did not wish to participate in filling out the survey or not able to fill out the survey.

['Teaching,education,feedback and practice sessions to help improve as needed']

['Resident Education and Assessment of Difficult and High Acuity Scenarios That Focus on Cardiac Anesthesia']


Helicobacter Pylori Empiric Treatment in Ulcer Bleeding

Summary: The goal of the study is to compare the effectiveness of empirical Helicobacter pylori treatment compared with treatment depending on diagnostic tests for Helicobacter pylori in patients with Upper gastrointestinal bleeding due to peptic ulcer. Main hypothesis is that empirical treatment will reduce the number of patients lost to follow-up thus improving the cure rates of Hp infection.
Inclusion criteria: inclusion criteria:

 Patients older than 18.

 Informed Consent signed.

 Diagnosis of no variceal upper gastrointestinal bleeding secondary to a duodenal ulcer, erosive duodenitis or gastric ulcer.

 Life expectancy longer than 6 months.

 Able to attend further clinical controls.

 Absence of the following
Exclusion criteria: .

['Empirical Hp eradication', 'Eradication treatment guided by a positive test']


Magnetic Resonance (MR) Spectroscopy and Diffusion Tensor Imaging in Determining Brain Injury and Subsequent Clinical Outcome in Patients of Moderate Brain Trauma

Summary: The purpose of this study is to use magnetic resonance spectroscopy (MRS) and diffusion tensor imaging (DTI) to assess for traumatic brain injury and determine if there is any correlation of these findings to clinical outcome. MR spectroscopy using 2D-CSI (a multi voxel technique) of the corpus callosum, basal ganglia, lobar white matter and brainstem may reveal areas of injury and quantification of the metabolites from these areas may be used to correlate with imaging findings and clinical evaluation. White matter disruption in these areas is commonly seen after TBI, caused by diffuse axonal injury. It has been implicated in the long term outcomes in these patients, but has been difficult to assess by standard radiologic studies.~By the use of DTI it may be possible to demonstrate damaged white matter tracts which could be helpful in the evaluation of traumatic brain injury. Most TBI subjects have injuries that involved torque to the brain. This results in a shearing injury to the long white matter tracts, which has been hypothesized to be related to cognitive outcome.~Also, to demonstrate that MRS and DTI prove valuable in predicting outcome in patients of moderate brain trauma by conducting progressive studies acutely (within 24 hours) and long term (4-6 weeks). Most patients will most likely be followed clinically for over a year, and, if clinical indicated, farther scanning can be done at a later date.~By comparing fraction anisotropy, ADC values, and metabolic ratios by the use of DTI and MRS in the adult and pediatric populations, may help to assess differences in recovery.~Lastly, a comparison between the two groups in changes in brain metabolism and/or white matter tract disruption/re-connection after TBI with and/or without links to outcome can be done.
Inclusion criteria: inclusion criteria:

 Patients of acute moderate brain trauma

Exclusion criteria: :

 Patients who are medically unstable or have CT findings that may interfere with the study such as:

 a large hemorrhage or edema

 encephalomalacia

 prior neurosurgeries

 hardware placed in the head or neck

 prior head trauma

 history of neurological conditions

['Conventional MRI of the brain', 'MR spectroscopy (MRS)', 'MR Diffusion Tensor Imaging (DTI)']

Conventional MRI of the brain
MR spectroscopy (MRS)
MR Diffusion Tensor Imaging (DTI)


Autoimmunity in Sisters of Lupus Patients

Summary: This study enrolled over 400 unaffected sisters of young women diagnosed with SLE. These unaffected sisters are being followed with an annual health questionnaire (CSQ) and blood sample.
Inclusion criteria: Sister Diagnosed with SLE:

 inclusion criteria:

 Proband must be a female and have documented SLE that meets ACR criteria. SLE must be diagnosed by and including age 40.

 Proband must have at least one biological sister ≥ 10 years of age and ≤ 45 who is available and willing to donate a blood sample and enroll in a longitudinal study. Both full and half siblings qualify.

Exclusion criteria: :

 If inclusion criteria above are met for the proband, there are no exclusions.

 Sister who does not have SLE:

 inclusion criteria:

 Female with a full or half sister who has been documented SLE that meets ACR criteria.

 Sister must be currently between ages ≥ 10 and ≤ 45 at the time of enrollment and not have a diagnosis of SLE.

 Sister must be able to complete questionnaires and should be willing to donate a blood sample at baseline and follow-up.

 Sister should communicate to the recruiter that she is willing to be followed for a period of at least two years by phone and/or internet.


Thoracoscopic Localization of Pulmonary Nodules Using Direct Intracavitary Thoracoscopic Ultrasound

Summary: Pulmonary nodules are one of the most common thoracic radiographic abnormalities. They are usually found accidentally as discrete well emarginated pulmonary lesions found within the lung parenchyma during a routine chest x-ray. Pulmonary nodules are usually asymptomatic. Most solitary lung nodules are benign; however these nodules can represent early stage lung cancer. The identification of malignant pulmonary nodules is important because they represent a potential form of curable lung malignancy. Every lung nodule should therefore be investigated for the possibility of malignancy.~Ultrasound has been beneficial in almost all medical and surgical specialities. The idea of using ultrasound during VATS has emerged from its use in laparoscopic procedures. Few studies have investigated the use intracavitary ultrasound for localizing pulmonary nodules. The sensitivity of ultrasound detecting pulmonary nodules is high (92%). In some studies, ultrasound could detect all pulmonary nodules detected by high resolution CT. It has also been shown to be able to locate nodules not visualized on spiral CT.~The use of intracavitary ultrasound has been suggested by many authors as a safe and effective method for localizing hard to find nodules. It is a real time technique with no associated complications, low cost, and has the potential to save operative time. Most importantly, it may be able to prevent conversion of VATS to open operations in cases where nodules are not visualizable or locatable using VATS techniques.~The use of intracavitary US as a localization method by surgeons intra-operatively could lead to better identification of nodules. Also, this technique could avoid performing multiple procedures on patients (CT guided targeting followed by surgery) and therefore is more cost-efficient. If proven accurate, surgeon-performed intracavitary ultrasound could be used routinely during VATS procedures, increasing the chances of finding and localizing pulmonary nodules using minimally invasive techniques.
Inclusion criteria: inclusion criteria:

 All patients with CT identified pulmonary nodules not deemed to be visualizable during VATS who are candidates for VATS resection.

Exclusion criteria: :

 Inability to consent for the study.

 Patients less than 18 years old.

 Patients with pulmonary nodules easily located during VATS.

 Patients with tumours extending to visceral pleura or chest wall.

 Patients who have chest anatomy precluding VATS resection.


Effectiveness of School-Based Cognitive Behavioral Therapy in Preventing Depression in Young Adolescents

Summary: This study will evaluate the effectiveness of the Penn Resiliency Program, a school-based cognitive behavioral depression prevention program for young adolescents.
Inclusion criteria: inclusion criteria:

 Student with above average levels of depression and anxiety symptoms (students with average or below average symptoms will be enrolled into the study space permitting)

Exclusion criteria: :

 Not a student in a participating school

 Not a student in grades six through eight

['Adolescent only Penn Resiliency Program (Adolescent PRP)', 'Parent Penn Resiliency Program (Parent PRP)']


Subclinical AtrIal FibrilLation and StrokE PreveNtion Trial

Summary: Introduction: Patients with atrial fibrillation (AF) have a substantial risk of stroke and systemic embolism. Subclinical AF is often suspected to be the cause of stroke in these patients. The detection of asymptomatic AF episodes is a challenge and the real rate of occurrence of these episodes remains unknown. The rate of stroke is high among patients who have received a pacemaker and this device can detect subclinical episodes of rapid atrial rate, which correlate with electrocardiographically documented AF. The net benefit of anticoagulant treatment is well established in patients with clinical AF but data about anticoagulation in subclinical AF setting is unknown. The aim of this study is to assess the impact of anticoagulant therapy on subclinical AF, directed by cardiac implantable electronic device (CIED) intensive monitoring, on the incidence of stroke and systemic embolism and correlate the AF episodes detected by CIED with thromboembolic events. Methods: This is a prospective, randomized, unicentric, parallel clinical study in patients with atrioventricular pacemaker, defibrillator, or cardiac resynchronization therapy devices in sinus rhythm and CHADS2 score (an index of the risk of stroke in patients with atrial fibrillation, range from 0 to 6) ≥ 2 . Patients will be randomized to the intervention group - intensive monitoring arm (Group I) or control group - routine schedule arm (Group II) in a 1:1 ratio. Time to inclusion will be 24 months and all patients will be followed up for a period of 36 months. Group I, patients will be submitted to device data collection every 2 months, while in Group II, patients will be managed conventionally. Patients from Group I with episodes of subclinical AF will receive anticoagulant therapy, as well as patients with clinical AF of both arms. Device data from Group II patients will not be analyzed until they achieve the primary endpoint. Primary endpoint: stroke or systemic embolism. Secondary endpoints: subclinical AF rate, total mortality, cardiovascular mortality, myocardial infarction, cardiovascular hospitalization, and bleeding rates. Expected outcome: It is expected that anticoagulation therapy of subclinical AF directed by CIED intensive monitoring will reduce the incidence of stroke and systemic embolism comparing to patients with non-diagnosed subclinical AF.
Inclusion criteria: inclusion criteria:

 Age >= 18 years

 CHADS2 score >=2

 Sinus rhythm

 Cardiac Implantable Electronic Device

Exclusion criteria: :

 Atrial fibrillation

 Severe heart valve disease

 Anticoagulation therapy

 Pregnancy


Typing of Human Papilloma Virus (HPV) From Female Genital Warts

Summary: This is a longitudinal observational study of women presenting to Groote Schuur Hospital with genital warts. The study will evaluate the socio-demographic characteristics of the women using a structured questionnaire. It will also document the site and extend of the genital warts and genotyping will be performed on the warts. HIV status will be determined with patient consent, treatment modalities will be documented as will the outcome of treatment over a 6 month's period. Risk factors for recurrence or failure of treatment will be analysed as will the costs of treating women with genital warts.
Inclusion criteria: inclusion criteria:

 All female patients with genital warts

Exclusion criteria: :

 Patients who are pregnant, too frail or ill for gynaeoclogical examination and refusal to participate

['Genital Warts', 'Human Papilloma Virus']


Molecular, Cytological Features and Genetic Susceptibility of COPD Attributable to Different Environmental Exposures 2

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

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

 Stable phase of COPD

 History of exposure to respirable silica dust, nonsmokers with no of passive exposure of tobacco smoke or history of exposure to aromatic hydrocarbons, nonsmokers with no of passive exposure of tobacco smoke or current tobacco smokers without history of occupational exposure

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

 Male

 Caucasian

 Age of 40 - 75 years old

Exclusion criteria: :

 history of biomass smoke exposure

 age less than 40 and above 75 years old

 current COPD exacerbation

 concomitant asthma

 tuberculosis and other pulmonary diseases

 allergic and autoimmune disorders

 active infections

 immunodeficiency, including HIV infection

 parasitological diseases

 malignancies

 lack of informed consent.

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

exposure to respirable silica dust
exposure to aromatic hydrocarbons

['Chronic Obstructive Pulmonary Disease']


The Safety and Effectiveness of Retrovir in HIV-Infected Patients Who Have Problems Related to the Nervous System

Summary: To assess the efficacy of Retrovir (AZT) therapy in the treatment of HIV Ab positive persons with impairments in neuropsychological functioning. To assess the safety, virologic, and immunologic effects of AZT therapy in HIV Ab positive persons with neuropsychological impairment but minimal other symptomatology.
Inclusion criteria:
Exclusion criteria:

 Co-existing Condition:

 Patients with the following are excluded:

 Neuropsychological (NP) impairments more severe than described in the inclusion criteria.

 Evidence of nervous system dysfunction being caused by factors other than HIV infection, including history of head trauma, multiple sclerosis, epilepsy, or presence of concurrent central nervous system (CNS) infections or neoplasms, e.g., toxoplasmosis, primary or metastatic CNS lymphoma, progressive multifocal leukoencephalopathy, cryptococcal or other fungal meningitis, and CNS tuberculous infections.

 Lymphoma or other tumor requiring cytotoxic chemotherapy.

 Concurrent Medication:

 Excluded:

 Other antiretroviral agents.

 Patients with the following are excluded:

 AIDS or advanced ARC.

 Neuropsychological (NP) impairments more severe than described above; i.e., defective performance on NP test battery in 3 or more NP areas on the NP screening battery at 2 standard deviations below the mean.

 Evidence of nervous system dysfunction being caused by factors other than HIV infection, including history of head trauma, multiple sclerosis, epilepsy, or presence of concurrent central nervous system (CNS) metastatic CNS lymphoma, progressive multifocal leukoencephalopathy, cryptococcal or other fungal meningitis, and CNS tuberculous infections.

 Prior Medication:

 Excluded:

 Antiretroviral agents including zidovudine (AZT).

 Prior Treatment:

 Excluded within 3 months of study entry:

 Blood transfusion.

 Impaired performance on a defined neuropsychological test battery.

 Asymptomatic HIV infection.

 Persistent generalized lymphadenopathy (PGL).

 Early AIDS related complex (ARC).

 Seropositive for human immunodeficiency virus (HIV) demonstrated by positive ELISA test and confirmed by Western blot with no or minimal symptomatology or HIV infection.

 Ability to give informed consent or a person with durable power of attorney who can give informed consent.

 Willingness to be followed by the originating medical center for 1 year.

 History of drug or alcohol abuse.


Evaluation of Trauma Team Activation Criteria

Summary: The aim of the study is to establish the predictive properties of our trauma team activation protocol, and its individual criteria, and if possible to suggest changes that reduce over- and undertriage.~The study will also give an overview of the frequency and type of emergency procedures at a university hospital trauma center, which can contribute to optimal resource use and indicate which type of surgical skills are necessary in our trauma emergency procedures.
Inclusion criteria: inclusion criteria:

 all patients admitted with the trauma team

 all patients admitted with Injury Severity Score >15

Exclusion criteria: :

 secondary admittance(transfers)>24 post injury


Comparison of MIS Anterior Versus MIS Anterolateral Approach

Summary: Aim of the present investigation is to analyse the amount of muscle trauma in relation to the surgical approach and to the individual postoperative functional recovery. The investigation will compare the MIS (minimally invasive surgery) anterior approach with the MIS anterolateral approach to the hip.
Inclusion criteria: inclusion criteria:

 unilateral, noninflammatory end-stage osteoarthritis of the hip

 willingness and ability to cooperate in the required post-operative therapy

 willingness and ability to provide written informed consent

 age 50-80 years

Exclusion criteria: :

 inflammatory arthropathies

 prior hip surgery

 prior infection of the hip

 severe morbidity

 severe osteoporosis

 inability to tolerate general anesthesia

 no contraindications to MRI e.g. pacemakers, claustrophobia

 neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care

 known alcohol or drug abuse

 unwillingness to participate