Radioactive Iodine in Treating Patients Who Have Undergone Surgery for Liver Cancer

Summary: RATIONALE: Radioactive iodine may be effective in reducing the rate of recurrence of liver cancer after surgery to remove the tumor. It is not yet known if radioactive iodine is more effective than no further treatment after surgery.~PURPOSE: Randomized phase III trial to determine the effectiveness of radioactive iodine in treating patients who have undergone surgery for liver cancer.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Histologically confirmed primary hepatocellular carcinoma (HCC)

 Completely resected disease with clear margins

 No residual disease by postoperative CT scan

 No metastatic disease

 PATIENT CHARACTERISTICS:

 Age:

 17 and over

 Performance status:

 Karnofsky 60-100%

 Life expectancy:

 Not specified

 Hematopoietic:

 WBC greater than 1,500/mm^3

 Platelet count greater than 50,000/mm^3

 Hepatic:

 Bilirubin less than 2.92 mg/dL

 PT less than 4 seconds over control

 Renal:

 Creatinine less than 2.26 mg/dL

 Other:

 No contraindication to contrast or radioactive iodine

 No uncontrolled thyrotoxicosis

 No other prior or concurrent malignancy

 Not pregnant or nursing

 PRIOR CONCURRENT THERAPY:

 Biologic therapy

 Not specified

 Chemotherapy

 Not specified

 Endocrine therapy

 Not specified

 Radiotherapy

 Not specified

 Surgery

 See Disease Characteristics

 Recovered from prior surgery

 Other

 No other prior treatment for HCC
Exclusion criteria:

['adjuvant therapy', 'iodine I 131 ethiodized oil']

adjuvant therapy
iodine I 131 ethiodized oil


Sitagliptin in the Elderly

Summary: Diabetes is common in the elderly; by the age of 70, approximately 25% of the population will have diabetes. Unfortunately, currently available medications are often not as effective or not well tolerated in older adults. Sitagliptin is a new medication in a new class of agent called incretins. Incretins have many potential advantages for the treatment of diabetes in the elderly. They stimulate insulin secretion, which is impaired in all older people with diabetes. The incidence of hypoglycemia with currently available medications increases with age, and incretins rarely cause hypoglycemia . They assist with weight loss, whereas many current medications used to manage diabetes result in weight gain in the elderly. They improve insulin action, and insulin resistance is a major problem in older people with diabetes.
Inclusion criteria: inclusion criteria:

 type 2 diabetes managed by diet or metformin only

 A1c < 8.5%

Exclusion criteria: :

 treated with insulin or oral agents other than metformin in the past 6 months

 evidence of diabetic complications including coronary artery disease, stroke, transient ischemic attacks, peripheral vascular disease, nephropathy, retinopathy, or neuropathy

 type 1 diabetes or a history suggestive of a secondary causes of diabetes

 A1c ≥ 8.5%

 participated in another clinical trial within the past 30 days


The Influence Of GIP (Glucose-Dependent Insulinotropic Polypeptide) Infusion On Human Adipose Tissue: An In Vivo Study

Summary: Study part-1~GIP (glucose-dependent insulinotropic polypeptide) is one of the two main incretin hormones secreted by specialized cells of the gastrointestinal tract in response to ingestion of nutrients. Data emerging from studies in animal models and cultured human fat cells support a physiological role for GIP in the adipose tissue metabolism which may contribute to the pathogenesis of obesity.~The proposed study will shed more light on the interactions between gut hormones and adipose tissue. For this pilot study, male subjects fulfilling the inclusion criteria will be given GIP or placebo infusions in a randomized manner. Fat tissue biopsies will be obtained from all subjects during both visits, once in the basal state (before the start of the peptide/placebo infusion) and then repeated at the end of the period of infusion.~Study part-2~Surgery represents the most effective therapeutic modality for morbid obesity. Resolution of type 2 diabetes mellitus (T2DM) has been consistently observed as an additional benefit of surgical treatment of obesity. The mechanisms underlying the dramatic effects of surgery on insulin sensitivity and β-cell function are poorly understood. Bariatric surgery (gastric bypass) promotes changes in the enteroendocrine system as a result of nutrient diversion from the physiological intestinal routes with subsequent profound modification of gut hormone secretion~We hypothesize that restoration of GIP action after bariatric procedures plays a cardinal role in the improvement and/or restoration of diabetes, we propose to study patients (both sex)with morbid obesity and T2DM within 3 months after their surgery. Their responses will be compared to those of BMI matched control subjects with normal glucose tolerance
Inclusion criteria: inclusion criteria:

 Lean (BMI 20-25 kg/m2) subjects with normal glucose tolerance

 Obese (BMI >30 kg/m2) subjects also with normal glucose tolerance.

 Obese with impaired glucose tolerance

 Obese with diet controlled diabetes mellitus

 Morbid obesity, type diabetes and post bariatric surgery (study part 2)

Exclusion criteria: :

 History of severe cardiac, hepatic or renal disease

 Thyroid dysfunction (hyper-or hypothyroidism), or other endocrine disturbance (acromegaly, growth hormone deficiency, hypoadrenalism or cortisol overproduction)

 Current malignant disease

 Known alcohol misuse

 Major psychiatric disease (including current use of antidepressants)

 History of major eating disorder (anorexia or bulimia nervosa)

['GIP (glucose dependent insulinotropic peptide) infusion']


DVT Ultrasound in the Emergency Department

Summary: Emergency Medicine (EM) Residents routinely conduct bedside ultrasound exams in the Emergency Department (ED) employing the two point compression method. This study endeavors to investigate the accuracy and utility of bedside ultrasound for Deep Vein Thrombosis (DVT) in the ED by EM Residents by comparing the results of that exam against the gold standard of a DVT ultrasound performed in the Radiology Department and interpreted by a Radiologist.
Inclusion criteria: inclusion criteria:

 Age 18 or older

 Suspect of having DVT

Exclusion criteria: :

 Known DVT

 DVT with in previous 6 months

 DVT Ultrasound within the last 6 months


Duke Lupus Registry

Summary: Lupus is a systemic autoimmune disease that can present with many varied symptoms, including joint pain, fevers, kidney disease, and rashes. Lupus can affect anyone, but it is most common in younger women.~The Duke Lupus Registry will collect information and blood samples from patients with lupus (systemic lupus erythematosus or cutaneous lupus) seen in the Duke Rheumatology clinics. The goal of this Registry is to understand how lupus changes over time so that we can improve the treatment of patients with lupus.
Inclusion criteria: inclusion criteria:

 Diagnosis of Systemic Lupus Erythematosus or Cutaneous Lupus

 Patient of a rheumatologist at Duke University Medical Center

Exclusion criteria: :

 Inability to travel to Duke for follow-up visits

 Inability to speak English

 Not able to provide informed consent

['Systemic Lupus Erythematosus', 'Cutaneous Lupus']

Systemic Lupus Erythematosus
Cutaneous Lupus


Improving Communication About Serious Illness

Summary: The purpose of this study is to improve care delivered to patients with serious illness by enhancing communication among patients, families, and clinicians in the outpatient setting. We are testing a new way to help patients share their preferences for talking about end-of-life care with their clinicians and families. To do this we created a simple, short feedback form. The form is designed to help clinicians understand what patients would like to talk about. The goal of this research study is to show that using a feedback form is possible and can be helpful for patients and their families.
Inclusion criteria: inclusion criteria:

 Eligible primary clinicians will include all clinicians who provide ongoing primary or specialty care to eligible patient populations. This will include primary care physicians (family medicine and internal medicine), oncologists, pulmonologists, cardiologists, gastroenterologists, nephrologists, neurologists, hepatologists, and geriatricians. Primary clinicians may also include nurse practitioners and physician assistants playing a primary role with eligible patients. A primary role denotes any clinician for whom having a discussion about end-of-life care with eligible patients would be indicated

 Eligible interprofessional team members will include nurses, social workers and other clinicians who are part of an enrolled primary clinician's clinic team.

 Eligible patients will be those under the care of a participating clinician who are 18 years of age or older, have had 2 or more visits with the primary clinician in the last 18 months, and meet diagnostic criteria. Diagnostic criteria include: 1) metastatic cancer or inoperable lung cancer; 2) chronic obstructive pulmonary disease with FEV1 values <35% predicted or oxygen dependence or restrictive lung disease with a TLC < 50% predicted; 3) New York Heart Association Class III or IV heart failure; 4) Child's Class C cirrhosis or MELD score of >17; 5) dialysis-dependent renal failure and either diabetes or a serum albumin of < 2.5; or, 6) older than 75 years with at least one life-limiting chronic illness or older than 90 years. Additional criteria include: PAH w. 6MWD <250m, restrictive lung disease (IPF, ILD) w/ TLC <50%, and cystic fibrosis with FEV1 < 30%. Eligible patients will also be English-speaking and have no significant dementia or cognitive impairment that would limit his/her ability to complete questionnaires.

 Eligible family members will be identified by the patient, with the criterion that the patient would want the family member involved in medical decision-making for the patient if he/she was not able. For the purpose of this study, family member is not confined to legal next-of-kin or immediate family member. Any family member, friend, or caregiver is eligible who is English-speaking and has no dementia or delirium limiting his/her ability to complete questionnaires.

Exclusion criteria: :

 Reasons for exclusion for all subject groups include: legal or risk management concerns; and physical or mental limitations preventing ability to complete research activities.

['Communication Feedback Form for Patients with Serious Illness']

['Critical Illness', 'Chronic Disease', 'Terminal Care', 'Palliative Care', 'Communication', 'Advance Care Planning', 'Neoplasm Metastasis', 'Lung Neoplasms', 'Pulmonary Disease, Chronic Obstructive', 'Heart Failure', 'End Stage Liver Disease', 'Kidney Failure, Chronic']

Critical Illness
Chronic Disease
Terminal Care
Palliative Care
Communication
Advance Care Planning
Neoplasm Metastasis
Lung Neoplasms
Pulmonary Disease
Chronic Obstructive
Heart Failure
End Stage Liver Disease
Kidney Failure
Chronic


A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression

Summary: This is a Pilot Study to get a first indication whether Duloxetine may be effective for depressed patients with Atypical Features.
Inclusion criteria: inclusion criteria:

 DSM-IV Major Depression or Dysthymia with Atypical Features

 Age 18-65

 Physically healthy

 HAMD(24) > 14

Exclusion criteria: :

 Prior experience with Duloxetine

 History of Psychosis or Bipolar Disorder, Borderline Personality Disorder

 Unstable medical disorder; any history of Epilepsy

 Currently taking medication that can interact with Duloxetine

 Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol)

 Serious suicidal ideation judged at least somewhat likely to be acted upon or require hospitalization

 Current (past two weeks) use of psychoactive medication (four weeks for Fluoxetine)

 Pregnancy

 Currently breast feeding

 Fecund women failing to use acceptable birth control

 Refractory Depression (defined as failure to respond to one or more adequate trials of marketed antidepressants [i.e., >=2/3 PDR maximum dose for at least 4 weeks] during current episode)

 Serious suicidal ideation, recent (past six months) suicidal activity, any life-time history of serious suicide attempt (e.g., admitted to ICU, any duration of coma)

 Currently taking medication deemed effective


Different Doses of IVIG for Kawasaki Disease

Summary: The objective of this study is to investigate the effect of different doses of intravenous immunoglobulin (IVIG) (1g/kg once, 1g/kg twice, 2g/kg once) for Kawasaki disease (KD) in a multicentre, prospective,randomised trial.
Inclusion criteria: inclusion criteria:

 Individual patient's medical file data confirmed the diagnosis of KD using the 5th revised edition of diagnostic criteria for KD, issued by the Japan Kawasaki Disease Research Committee at the 7th International Kawasaki Disease Symposium in 2002.

 the patients aged from 1 months to 12 years old.

 All included patients required to sign an informed consent form.

 the patients didn't receive treatment before.

Exclusion criteria: :

 The patients with the application of hormone or other immunosuppressive agents;

 The patients didn't want to signed informed consent.

['IVIG (1g/kg,once)', 'IVIG (1g/kg,twice)', 'IVIG (2g/kg.once)']

IVIG (1g/kg,once)
IVIG (1g/kg,twice)
IVIG (2g/kg.once)


MRI Study of Brain Activity and Risk for Depression in Adolescents

Summary: Anxiety in children of parents with major depressive disorder (MDD) poses a particularly high risk for later-life MDD. In adults, MDD involves dysfunction in prefrontal brain regions that regulate attention to emotional stimuli. These abnormalities: i) have been found primarily in adults with specific familial forms of MDD; ii) persist after recovery from MDD, and iii) relate to anxiety. These findings raise the possibility that risk for MDD is tied to dysfunction in prefrontal regions involved in regulation of emotion, which possibly manifests as early-life anxiety. If this possibility were confirmed in never-depressed adolescents at high risk for MDD, the findings would provide key insights into the developmental neurobiology of MDD. The goal of this protocol is to study the neural substrate of risk for MDD in young people. This protocol tests the hypothesis that adolescents at high risk for MDD by virtue of childhood anxiety and parental history of MDD exhibit dysfunction in prefrontal cortex and amygdala, regions involved in emotion regulation. This goal will be accomplished through fMRI studies of emotion regulation in high and low-risk adolescents.~For this research, at-risk adolescents will be recruited from participants in an NIMH-funded extramural study at New York University (NYU) examining the biology of risk for anxiety and depressive disorders. Over a three-year period, 45 high-risk probands and 60 low-risk comparisons will be studied, including 20 comparisons from the NYU sample and 40 from the Washington DC metropolitan area. In the present protocol, to be conducted at NIH, subjects will undergo volumetric MRI scans to assess structural abnormalities in the prefrontal cortex and medial temporal lobe. They will complete a series of four out-of-scanner cognitive tasks and two fMRI-based cognitive tasks that measure modulation of attention to emotional stimuli. The fMRI tasks are hypothesized to differentially engage the prefrontal cortex and amygdala in low vs. high risk subjects. These tasks will be used to test the hypothesis that at-risk individuals exhibit enhanced amygdala and reduced prefrontal activation on the fMRI emotion/attention tasks.
Inclusion criteria: OFFSPRING SUBJECTS - inclusion criteria:

 Age: 10-30.

 Can give consent/assent. Parents will provide consent for all minors.

 All subjects will have IQ greater than 80.

 High risk Psychopathology: Offspring of adults with a history of MDD.

 Low risk Psychopathology: Offspring of adults with no history of MDD and low developmental levels of emotion dysregulation. Subjects born to parents with only anxiety disorders will be included in this group.

 OFFSPRING SUBJECTS -
Exclusion criteria: :

 Any medical condition that increases risk for MRI (e.g. pacemaker, metallic foreign body in eye).

 Pregnancy:

 Both groups: All subjects will be free of current impairing affective disorders, separation anxiety disorder, social anxiety disorder, panic disorder, generalized anxiety disorder, PTSD, ADHD, as well as lifetime history of substance dependence, psychosis, pervasive developmental disorder, major affective disorder, obsessive compulsive disorder, conduct disorder, anorexia. All subjects will be born to parents with no history of schizophrenia or bipolar disorder.

 PARENT SUBJECTS - inclusion criteria:

 Age: 18-55

 Can give consent/assent

 Offspring: All subjects will have offspring participating in this same protocol.

 Have an IQ greater than 80

 Past history of MDD

 No lifetime history of MDD

 ADULT SUBJECTS -

['Involutional Depression', 'Anxiety Disorders']

Involutional Depression
Anxiety Disorders


Tissue and Hematopoietic/Mesenchymal Stem Cell for Humanized Xenograft Studies in Melanoma and Squamous Head and Neck Cancer

Summary: The overall goal of this study is to develop a pre-clinical platform of melanoma and head and neck squamous cell cancer that will allow the investigators to learn more about these diseases and discover better and more individualized treatments.
Inclusion criteria: inclusion criteria:

 Biopsy proven incurable melanoma or incurable HNSCC amenable to have biopsy and/or surgical resection of either the primary and/or locoregional metastatic site, at the University of Colorado Hospital.

 Age ≥ 21 years old per NCI/NIH guidelines

 Eastern Cooperative Oncology Group (ECOG) performance status of 0. 1, or 2

 Adequate bone marrow, hepatic and renal function:

 Absolute neutrophil count ≥ 1,500/µL.

 Platelets ≥ 100,000/µL.

 Hemoglobin ≥ 9.0 g/dL.

 Creatinine ≤ 1.5x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min.

 Total bilirubin ≤ 1.5x ULN.

 Aspartate Aminotransferase (AST)/Alanine Aminotransferase ( ALT) ≤ 2x ULN.

 Measurable disease according to Response Criteria in Solid Tumors (RECIST) version 1.1.

 O2 saturation ≥= 93% at room air.

 Ability to understand and willingness to sign a written informed consent document

Exclusion criteria: :

 Contraindication (absolute or relative) to granulocyte colony-stimulating factor (G-CSF) filgrastim usage:

 known hypersensitivity to E coli-derived proteins' filgrastim, or any other component of the product.

 Sickle cell disorders.

 Clinically significant and active lung hemorrhagic or inflammatory disease, including but not limited to chronic obstructive pulmonary disease (COPD), autoimmune disease, and alveolar hemorrhage; or hypoxemia of any etiology requiring oxygen.

 Clinically significant splenomegaly or splenic metastases; history of splenic rupture, recent splenic trauma or other clinically significant splenic disease that increases the risk of splenic rupture.

 Clinically significant and active malignancy other than incurable melanoma or head and neck squamous cell cancer.

 Known hepatitis B or C, or HIV.

['Malignant Melanoma', 'Head and Neck Cancer']


Consequences of DNA Repair and Telomere Defects on the Function of the Immune System: Application to CVID and Immune Deficiencies With Dysmorphic Syndromes

Summary: The molecular mechanisms participating in the various aspects of the DNA Damage Response (DDR) are absolutely essential to maintain the genome dynamics essential to all living organisms. The most commonly studied consequence of faulty DDR is genome instability participating in cancer onset. In the present proposal, we wish to explore another aspect of DDR, not relevant to cancer, which is its absolute requirement at several key steps of the development, maturation, and function of the immune system.~The most spectacular consequences of faulty DNA repair processes with respect to the immuno-hematopoietic tissue are the complete block of B and T lymphocytes maturation owing to defective DNA joining phase during V(D)J recombination resulting in patients with Severe Combined Immune Deficiency (SCID).~The objectives of this study are to increase our knowledge on the role of the various DNA repair processes in the development, the maintenance, and the function of the immune system and thus, to better understand why and how dysfunctions of these DNA repair processes result in human severe conditions such as CVID, LOCID or other manifestations of immune disorders such as autoimmunity.~The explorations of DNA repair mechanisms in the patients will allow us to establish the genetic diagnosis in some patients with until now undefined molecular diagnosis. This is of immediate importance for the patients and their families, as it not only contributes to a better understanding of the patients' condition, but also allows providing genetic counseling for the families.
Inclusion criteria: inclusion criteria:

 Immune Deficiency and early BMF in childhood

 Common Variable Immunodeficiency (CVID)

 Genetic patients

Exclusion criteria: :

 Refusal to consent.

['Immune Deficiency and Early BMF in Childhood']


Identification of Early Predictors of Fetomaternal Hemorrhage

Summary: Objectives: 1) To determine risk factors for fetomaternal hemorrhage. 2) To identify a cost-effective method to detect fetomaternal hemorrhage prior to significant fetal anemia.~Significance/Background: Fetomaternal hemorrhage (FMH) is a condition in which occurs when the placenta transfers blood from the fetus to the mother. Normally, nutrition and gasses pass from mother to baby through the placenta and only waste products pass from baby to mother through the placenta. Whole blood cells do not normally cross the placenta in significant amounts. Mild FMH, where a small amount of whole blood passes from fetus to mother but does not hurt the mother or baby, occurs in about 75% of pregnancies. A pregnant woman does not know this occurs. It is only discovered if a special blood test that is labor-intensive to perform and difficult to interpret called the Kleihauer-Betke acid elution test is done. As mild FMH hurts no one, this test is not part of routine care. In most cases, testing is done only if a baby is born sick with unexplained anemia. Severe FMH, which can cause the baby to become sick from anemia (low red blood cell count) is caused by large blood loss into the mother, occurs in only 1-3 per 1000 births. Severe anemia caused by FMH can result in death of the baby before or after birth, or significant illness in the newborn period. Short term problems for the baby include difficulty breathing, difficulty maintaining blood pressure, and difficulty providing oxygen to all parts of the body. This can cause multiple problems with the function of internal organs including the liver, kidneys, intestines, and brain. Babies who become sick from severe FMH can develop long-term problems including cerebral palsy (a lifelong problem with body movements) and/or mental retardation.~It is not known why some pregnancies are affected by FMH and others are not. It is thought that FMH may occur more frequently now than in the past, but no one knows why. If identified early, FMH is readily treatable by blood transfusion of the baby before or after birth and/or early delivery. Current laboratory testing for FMH is difficult and expensive. There is great need identify high risk patients early in pregnancy in order to treat the condition before the baby gets sick.~Approach: Five hundred women will be asked to participate in the study at the time they are admitted to the Mount Sinai labor floor for delivery at term. After birth, newborns of study mothers will be tested for anemia. Mothers of anemic babies will donate blood for confirmation of FMH by established laboratory methods as well as for development of a new laboratory screening protocol. All mothers will provide medical, social, environmental, and full pregnancy history. Risk factors for FMH will be identified by statistical analysis of this information.
Inclusion criteria: inclusion criteria:

 Women admitted for term delivery (delivery between 37 0/7 and 41 6/7 weeks from the last menstrual period) to the Mount Sinai Medical Center

Exclusion criteria: :

 Women carrying fetuses with known fetal anomaly.

 Women unable to complete the consent process due to likely precipitous delivery, severe labor discomfort, or fetal distress requiring immediate intervention.

['Fetomaternal Hemorrhage', 'Neonatal Anemia']


Pilot Safety Study of Coronary CTA for the Diagnosis of Acute Coronary Syndrome in the Emergency Room

Summary: The Diagnosis of acute coronary syndrome in patients presenting with acute chest pain is problematic when both, electrocardiogram and serum troponins are normal. Multidetector row computed tomography angiography (CTA) allows direct and rapid non-invasive visualization of coronary artery disease.~The investigator's aim is to assess the diagnostic accuracy and safety of a novel diagnostic strategy based on MDCT as compared to a strategy using stress echocardiography in the workup of patient with chest pain, normal electrocardiogram, normal troponins and suspected coronary artery disease. Additionally, the cost associated with both strategies will be compared.~Methods. A total of 150 patients with acute chest pain coming to the emergency room with intermediate probability of significant coronary artery disease, normal ECG and troponins will be prospectively randomized to MDCT or stress echocardiography with exercise. Patients showing coronary stenosis >50% at MDCT or abnormal stress echocardiography or inconclusive results will be admitted for further study. The primary endpoint of the study is the detection of an acute coronary syndrome, defined as typical or atypical angina with documented significant coronary artery disease (>50% stenosis) on invasive coronariography, a positive stress test or the occurrence of cardiac death, myocardial infarction or need for revascularization during 6 month follow-up. All MDCT angiograms and echocardiograms will be evaluated by an experienced radiologist and cardiologist.
Inclusion criteria: inclusion criteria:

 Patient is in Sinus Rhythm

 Typical or atypical chest pain lasting more than 5 min in the last 24 hs.

 Estimated pre-test probability of significant coronary artery disease more than 15%.

 Absence of ECG changes suggestive of myocardial ischemia (ST-segment deviation >1 mm or T Wave inversion > 4 mm in at least two contiguous leads).

 Negative initial troponins I at admission (<0.05 ng/ml)

Exclusion criteria: :

 Known allergy to iodinated contrast.

 Known renal insufficiency or Creatinine >1.5 mg/dl at admission.

 History of known coronary artery disease or prior myocardial revascularization

 Any of the following:hemodynamic instability, persistent chest pain despite treatment, Systolic blood pressure <100 mm Hg.

 Cardiac arrhythmia with rapid or irregular ventricular response.

 Inability to perform an exercise test.

 Patient is incapable of providing informed consent.

['computed coronary angiography', 'Exercise stress echocardiography']

computed coronary angiography
Exercise stress echocardiography

['Acute Coronary Syndrome', 'Coronary Artery Disease', 'Cardiac Death', 'Myocardial Infarction']

Acute Coronary Syndrome
Coronary Artery Disease
Cardiac Death
Myocardial Infarction


Clinical Trial of Bilhvax,a Vaccine Candidate Against Schistosomiasis

Summary: The purpose of this clinical study is to evaluate safety and immunogenicity in adult healthy volunteers of the vaccine candidate against schistosomiasis named Bilhvax.
Inclusion criteria: All subjects had to meet the study inclusion criteria within 21 days prior to treatment,

 inclusion criteria:

 Caucasian volunteers

 No smoker

 biological parameters (haematological, biochemical, renal and hepatic) in normal range

 Health Insurance

 sign inform consent

Exclusion criteria: :

 inflammatory or immunological pathology such as atopic diseases, evidence of inflammation or acute infection (including positive serology to viral hepatitis B and C or HIV)

 any immunological deficiency

 any clinically relevant alcohol or drug use (cannabis, opiates, cocaine, amphetamines, benzodiazepines, nicotine, barbiturates, meprobamate or antidepressant drugs according to urine drug and metabolites screen)

 current immunosuppressor treatment

 any other medication use within 2 weeks before the study

 any vaccination within the last 6 months

 no antibodies against Sh28GST protein.

['Schistosomiasis', 'Bilharziasis', 'Urinary Schistosomiasis']

Schistosomiasis
Bilharziasis
Urinary Schistosomiasis


Comparison of Blood Product Use and Bleeding Events During and After Endoscopic or Neurosurgical Procedures in Patients With Cirrhosis and Coagulopathy

Summary: A prospective, randomized clinical trial comparing blood product use and bleeding events during and after endoscopic or neurosurgical procedures in patients with cirrhosis and coagulopathy: Rotational Thromboelastometry (ROTEM) vs. conventional therapy (SCARLET).
Inclusion criteria: inclusion criteria:

 Patients 18 and older, admitted to the hospital

 Patients who have clinically documented cirrhosis

 Patients who are coagulopathic (INR > 1.5 and/or platelets < 50,000)

 Patients undergoing an endoscopic procedure or neurosurgical procedure

Exclusion criteria: :

 Patients must not be pregnant

 Patients must not be taking any anticoagulant or antiplatelet medication (with the exception of ASA 81 mg or heparin for DVT prophylaxis)

 Patients must not have an active infection (per PI discretion)

 Patients must not have any known hemostatic disorder


Evaluation of Two Different Thickening Products in Patients With Dysphagia

Summary: Dysphagia is extremely common. The importance of providing adequate nutritional support to persons with dysphagia is the cornerstone to exceptional care. Diet modification with thickening agents is an essential aspect of this nutritional support. The purpose of this investigation is to compare the efficacy of a starch based (Thickenup or TU) to a gel based thickening agent (Thickenup Advance or TUA).
Inclusion criteria: inclusion criteria:

 History of dysphagia necessitating a dynamic fluoroscopic swallow study

 Age > 18 years

 Ability to complete a comprehensive dynamic fluoroscopic swallow study

 Ability to provide informed consent for study participation

Exclusion criteria: :

 Age < 18 years

 Pregnant women

 Prisoner or other institutionalized individual

 Cognitive disability precluding the ability to provide informed consent or complete a comprehensive swallow study


The EPIC Project: Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines

Summary: Evaluation of the impact (on survival and other outcomes) of implementing the Brain Trauma Foundation/National Association of EMS Physicians Traumatic Brain Injury (TBI) guidelines in the prehospital EMS systems throughout the state of Arizona.
Inclusion criteria: inclusion criteria:

 Adults and children with physical trauma who: 1) are transported directly to or are transferred to a level I TC by participating EMS agencies, 2) have hospital diagnosis(es) consistent with TBI (either isolated or multisystem trauma that includes TBI), and 3) meet at least one of the following definitions for severe TBI: a) last prehospital GCS or first hospital/trauma center GCS <9; b) AIS-head of ≥3, c) CDC Barell Matrix-Type 1, d) undergo prehospital ETI, nasal intubation, or cricothyrotomy.

Exclusion criteria: :

 Patients with brain injury from: 1) non-mechanical mechanisms (e.g., drowning); 2) choking, primary asphyxiation, or strangulation; 3) environmental injury (e.g., hyperthermia); 4) poisoning (e.g., drug overdose, carbon monoxide, insecticides); 5) intracranial hemorrhage of non-traumatic origin; 6) other non-traumatic, acute neurological emergencies (e.g., bacterial meningitis).

['The National Prehospital TBI Management Guidelines']

['Brain Injuries, Traumatic', 'Injuries, Acute Brain', 'TBI (Traumatic Brain Injury)']

Brain Injuries
Traumatic
Injuries
Acute Brain
TBI (Traumatic Brain Injury)


Identification the Cause of Cerebral Infarction in Patients With Cancer

Summary: Although there has been increasing interest in the association between cancer and cerebrovascular disease, the underlying pathophysiology of stroke in cancer patients is still not fully understood. The aim of this study is to investigate the stroke mechanisms in patients with cancer-associated stroke.
Inclusion criteria: inclusion criteria:

 Subjects with acute ischemic stroke who presented within 7 days from symptom onset

 Subjects who had embolic infarction outside the perforator territory revealed by diffusion-weighted imaging

 Subjects with undetermined cause of stroke despite of initial evaluation including electrocardiogram and brain imaging upon admission

 Subjects who performed brain magnetic resonance image (MRI) and MR angiography (MRA), cardiac work-ups (12-lead electrocardiography, transthoracic and/or transesophageal echocardiography with injection of agitated saline (or agitated saline transcranial Doppler monitoring), and 24-hour Holter and/or telemonitoring)

 Subjects with informed consent

Exclusion criteria: :

 Subjects with single subcortical infarction

 Subjects with primary brain tumor

 Inability to perform comprehensive studies

 Refusal or withdrawal of the consent

['Cryptogenic Embolic Stroke', 'Active Cancer']

Cryptogenic Embolic Stroke
Active Cancer


Follow-up Study of the RAI-Treated Hyperthyroid Patients

Summary: Previous studies of hyperthyroid patients suggest that they remain at increased risk of cardiovascular morbidity after restoring euthyroidism.~The study objective is to compare the rate and causes of hospitalization of hyperthyroid patients treated with radioactive iodine (RAI) with those of an age- and gender-matched reference population in a long-term follow-up study.
Inclusion criteria: inclusion criteria:

 Patients: Radioiodine treatment for hyperthyroidism given in the Tampere University Hospital between January 1969 and June 2002

 Controls: age- and gender-matched control subject identified for each patient from the Population Register Centre. The control subject had to be alive at the time when the patient received the first RAI treatment
Exclusion criteria:

['Hyperthyroidism', 'Cardiovascular Diseases', 'Atrial Fibrillation']

Hyperthyroidism
Cardiovascular Diseases
Atrial Fibrillation


Platelet-Rich Plasma vs Corticosteroid Injection as Treatment for Degenerative Pathology of the Temporomandibular Joint

Summary: 1.0 BACKGROUND AND HYPOTHESES~1.1 Osteoarthritis is a continuous and entirely physiologic adaptive process that occurs in every joint. These include the replication of cells that produce matrix, enzymes, protease inhibitors, cytokines, and other peptides. Along with the synthesis of new tissue there is a release of breakdown products into the synovial fluid. Enzymes and phagocytes are required to clear these breakdown products. Normal tissue turnover involves synthesis and breakdown in well-regulated balance. In the degenerative state this balance is upset producing inflammation-derived alterations to the synovium, cartilage, capsule, tendons, and bone. Common causes of such alterations include increased loading, physical stress, and traumatic injury to the joint.~1.2 The rationale for the use of corticosteroids in temporomandibular joint therapy is that they inhibit prostaglandin synthesis and decrease the activity of collagenase and other enzymes that degrade the articular cartilage. Platelet rich plasma is a novel therapeutic agent that has several potential advantages over corticosteroids for the treatment of degenerative pathology of the temporomandibular joint. Platelet rich plasma has been shown to have anti-inflammatory, analgesic, and anti-bacterial properties. It also restores intra-articular hyaluronic acid, increases glycosaminoglycan condrocyte synthesis, balances joint angiogenesis, and provides a scaffold for stem cell migration. Autologous platelet rich plasma injections for treatment of knee cartilage degenerative lesions and osteoarthritis have shown longer efficacy than hyaluronic acid injections in reducing pain and recovering articular function. Similarly, platelet rich plasma has shown to have better outcomes than corticosteroid injections in the management of lateral epicondylitis, and better outcomes than hyaluronic acid injections in the management of osteochondral lesions of the talus.~1.3 Current treatments for degeneration and osteoarthritis of the temporomandibular joint are focused primarily on palliation by reducing inflammation and inflammatory mediators. This study seeks to validate a therapeutic agent that has the potential to actively prevent the progression of degeneration in addition to reducing pain and inflammation
Inclusion criteria: inclusion criteria: The following diagnostic criteria for patient selection are to be used:

 Patients will need to have a history of chronic pain (at least 3 months) refractory to conservative therapy with non-steroidal anti-inflammatory medications, muscle relaxants, diet modifications and splint therapy

 Patients will also need to have imaging findings (radiography or magnetic resonance imaging) that show mild to severe degenerative changes of the temporomandibular joint

Exclusion criteria: :

['Group A (corticosteroid injection group)', 'Group B (platelet rich plasma injection group)']


Atrial Fibrillation and Congestive Heart Failure Trial

Summary: Heart failure is a clinical syndrome where the heart is unable to pump enough blood to satisfy the organism's metabolic needs. Heart failure has become a major clinical and public health problem with approximately 300,000 Canadians being affected. Atrial fibrillation is a rhythm disorder in which the upper chambers of the heart (the atria) are paralyzed by continuous electrical activity. Some of the continuous chaotic electrical activity in the atria travels to the lower cavities of the heart (the ventricles) causing then to beat irregularly and very rapidly. It is the most frequent cardiac arrhythmia, affecting 5% of individuals 65 years and older and it is associated with an increased risk of stroke. Both conditions (heart failure and atrial fibrillation) often co-exist in the same patient. Heart failure promotes atrial fibrillation and atrial fibrillation aggravates heart failure. The Atrial Fibrillation and Congestive Heart Failure (AF-CHF) trial is investigating whether preservation of normal cardiac rhythm influences mortality and morbidity. The AF-CHF study began in 2001 and 1,378 patients have been enrolled from 123 participating centres, in North America, South America, Europe, and Israel. The results of this trial which are expected in October 2007, will improve decision-making for the physician and will provide useful information to healthcare organizations responsible for the care of heart failure patients.
Inclusion criteria: inclusion criteria:

 Left ventricular ejection fraction </=35% as measured by nuclear imaging, echocardiography, or cardiac angiography within 6 months preceding enrollment. If the patient has had a myocardial infarction or heart surgery during this period, the ejection fraction must be remeasured.

 Symptomatic CHF (NYHA class II-IV) at some time during the 6 months before randomization, despite therapy with an ACE inhibitor (however, patients who do not tolerate an ACE inhibitor are eligible). Asymptomatic patients (NYHA class I) with either a prior hospitalization for CHF during the 6 months before randomization or with a left ventricular ejection fraction of </=25% are also eligible.

 History of significant AF, defined as either:

 one episode lasting >/=6 hours (duration of AF will be determined by history), within the past 6 months with electrocardiographic confirmation; or

 an episode lasting >/=10 minutes (by history) within the past 6 months with electrocardiographic confirmation in a patient with a prior electrical cardioversion for AF.

 In the opinion of the clinical investigator, the patient must be eligible for long-term treatment with either treatment strategy of AF.

Exclusion criteria: :

 AF is known to be present and uninterrupted for more than 12 months prior to randomization. However, if such a patient is cardioverted and maintained in sinus rhythm for >/=24 hours, he or she becomes eligible.

 Reversible cause of AF such as acute pericarditis, pulmonary embolism, hyperthyroidism, alcohol intoxication.

 AF occurring and not persisting beyond 10 days of surgery or myocardial infarction.

 Reversible cause of CHF such as severe aortic or mitral stenosis and tachycardia-induced cardiomyopathy.

 Decompensated CHF within 48 hours of randomization.

 Antiarrhythmic drugs other than calcium channel blockers, beta-blockers or digoxin required for other arrhythmias or other indications.

 More than 7 days of amiodarone therapy within the last month prior to randomization.

 Second or third degree AV block, sinus pause >3 seconds, resting heart rate <50 bpm without a permanent pacemaker.

 History of drug-induced Torsades de Pointes or congenital long QT syndrome.

 Prior AV nodal ablation or Maze surgery.

 Probable cardiac transplantation in the next 6 months.

 Chronic renal failure requiring dialysis.

 Women of child-bearing potential and not on a reliable method of birth control.

 Geographic or social factors, drug or alcohol abuse making follow-up or compliance difficult.

 Other noncardiovascular medical condition (such as cancer) making 1 year survival unlikely.

 Less than 18 years of age.

['Rate vs rhythm control strategies for atrial fibrillation', 'Rate vs rhythm control strategies in atrial fibrillation']

['Atrial Fibrillation', 'Congestive Heart Failure']

Atrial Fibrillation
Congestive Heart Failure


Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Summary: This study aims at collecting the information related to the safety and effectiveness in the pancreatic exocrine insufficiency patients due to cystic fibrosis receiving the treatment with LipaCreon in order to evaluate the effective and safe use of LipaCreon.
Inclusion criteria: inclusion criteria

 Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency due to cystic fibrosis

Exclusion criteria:

 Patients with a history of hypersensitivity to the ingredient of LipaCreon.

 Patients with a history of hypersensitivity to porcine protein

['Cystic Fibrosis', 'Exocrine Pancreatic Insufficiency', 'Pancreatic Diseases', 'Digestive System Diseases']

Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases


Cervical Cancer Screening With Human Papillomavirus Testing

Summary: HPV testing for primary cervical cancer screening of women over 30 years of age is likely to become the standard of care in the near future in many areas of the world. Its high sensitivity can significantly improve the effectiveness of screening programs and its prolonged negative predictive value can allow extension of screening intervals. However, a single HPV test has low positive predictive value and can lead to unnecessary workup and over-treatment and generate unnecessary distress. This multi-centric study will screen 50,000 women with HPV testing and compare several triage approaches that can follow HPV testing in order to make an HPV-based screening programme efficient, affordable and sustainable.
Inclusion criteria: inclusion criteria:

 Aged 30-64 years

 Mentally competent to be able to understand the consent form

 Able to communicate with study staff

 Physically able to have a pelvic exam

Exclusion criteria: :

 Reporting no previous sexual activity

 History of cervical cancer

 Previous treatment for cervical pre-cancer in the last six months

 Hysterectomy

 Plans to move out of the study area in the next 12 months

 Screened for cervical cancer in the last 12 months (depending on local regulations)


A Pilot Study on the Use of Nociceptive Flexion Reflex for Fibromyalgia

Summary: The investigators are doing this study to better understand the role of the central nervous system in processing painful stimuli in patients with fibromyalgia. Specifically, the investigators would like to know whether the central nervous system processing of painful stimuli changes with time and with talk therapy. In addition, the investigators are investigating how changes in your fibromyalgia symptoms may affect certain markers or proteins in your blood.
Inclusion criteria: inclusion criteria:

 1. Female volunteers who have been diagnosed with fibromyalgia by a rheumatologist.

 2. Overall body pain average score ≥ 4

 3. Age range: 18 to 65 years old

 4. You must be on stable doses of anyone of these fibromyalgia-related medications for at least 4 weeks: cyclobenzaprine, tramadol, gabapentin, pregabalin, amitriptyline, nortriptyline, trazodone, sertraline, fluoxetine, paxil, remeron, venlafaxine and duloxetine.

 5. Willingness to restrict any change (add or switch or change in the dose) of any fibromyalgia-related medication for 12 weeks.

Exclusion criteria: :

 1. Volunteers who have long-standing history of diabetes (> 2 years), or have been diagnosed with any type of peripheral neuropathy.

 2. Have a prior history of myocardial infarction (heart attack) or unstable angina or other heart arrhythmias.

 3. Have been diagnosed with multiple sclerosis or any other demyelinating disorder.

 4. Have planned to undergo an elective surgery over the next 12 weeks.

 5. Have other major rheumatic conditions (i.e. rheumatoid arthritis, systemic lupus erythematosus, scleroderma and other connective tissue disease)

 6. Are currently pregnant or actively trying to become pregnant


The Impact of High Intensity Exercise Upon EPC Number and Function in Young Women

Summary: The purpose of the study is to examine the effects of different exercise intensity training programs upon blood vessel function and circulating blood cells involved in blood vessel repair in young women. The long term effects of exercise may be beneficial to cardiovascular health and it is important to understand the training methods that are the most beneficial. In particular we aim to determine if brief maximal exercise improves the function and stiffness of blood vessels and enhance blood vessel repair. Two methods of exercising are being compared, exercise bouts involving intermittent exercise and exercise completed all at once, but at a very high intensity.
Inclusion criteria: inclusion criteria:

 Young healthy females

 Between 18-25 years old

 No on medication (this includes contraceptives)

Exclusion criteria: :

 Medication use (including oral contraceptives)

 Amenorrhoea

 High blood pressure

 Very active (>3 hours per week of organized physical activity)

['Sprint interval exercise', 'Maximal continuous exercise']

Sprint interval exercise
Maximal continuous exercise


Study of Preoperative Management of Angiotensin Converting Enzyme Inhibitor (ACEi) and Angiotensin Receptor Blocker (ARB) Medications

Summary: Patients on a stable dose of ACE inhibitor or ARB medication who are scheduled for elective surgery will be randomized to take their ACE inhibitor or ARB up to and including the morning of surgery, or to hold them a day prior to the surgery. The patients will be followed for 30 days after surgery to assess any adverse health outcomes.
Inclusion criteria: inclusion criteria:

 currently taking an ACEi, ARB or both

 no change in these medications during the two weeks prior to study enrollment

 scheduled for non-cardiac surgery requiring regional or general anesthesia

 minimum overnight anticipated length of stay

 age ≥18 years.

Exclusion criteria: :

 explicit instructions provided to patient by surgical team regarding the perioperative management of ACEi or ARB

 significant hypertension in pre-operative assessment clinic (systolic blood pressure ≥180 mmHg OR diastolic blood pressure ≥110 mmHg)

 significant hypotension in pre-operative assessment clinic (systolic blood pressure < 90 mmHg)

 prior enrollment in the study

 participation in another research study of antihypertensive medications


Slow Initial β-lactam Infusion With High-dose Paracetamol to Improve the Outcomes of Childhood Bacterial Meningitis

Summary: The main purpose of this trial is to test if mortality of childhood bacterial meningitis can be reduced by slow, continuous infusion of cefotaxime initially, instead of the traditional bolus administration four times daily (qid), combined with high-dose paracetamol orally, when both treatments are executed for the first 4 days. The series will be collected at Hospital Pediátrico David Bernardino, Luanda, Angola.~The recruitment of patients begins, the conditions permitting, in early 2012. The criteria for patient participation is a child at the age of 2 months to 15 years who presents with the symptoms and signs suggestive of bacterial meningitis, for whom a lumbar puncture is performed, and the cerebrospinal fluid analysis suggests bacterial meningitis.
Inclusion criteria: Eligibility criteria:

 The study entry is assessed for all children at age 2 months - 15 years who present at these centers with the symptoms and signs suggestive of bacterial meningitis (BM), and to whom lumbar puncture is performed.

 inclusion criteria:

 All patients whose cerebrospinal fluid (CSF) turns out to be cloudy, positive by Gram staining or latex agglutination, or shows at least 50 leukocytes per mm3, will be enrolled in the study.

 Participants:
Exclusion criteria:

['Infusion with paracetamol', 'Bolus without paracetamol']

Infusion with paracetamol
Bolus without paracetamol


Aspergillus PCR Early Detection in High Risk Oncohematological Patients

Summary: ADVANCE THERAPY ASPERGILLOSIS INVASIVE BY PCR DETECTION
Inclusion criteria: inclusion criteria:

 Signature of informed consent to participate in the study.

 Adult patients (> 18 years), diagnosed with acute myelogenous leukemia or myelodysplastic syndrome with chemotherapy (CT) intensive, or admitted to undergo allogeneic hematopoietic progenitor cells, or transplantation with graft versus host disease.

 The patient should be included in this protocol from the start of their chemotherapy or conditioning therapy as reflected in another section.

Exclusion criteria: :

 Employment of antifungal prophylaxis (30 days prior to inclusion) with triazole / polyene with activity against Aspergillus (itraconazole, voriconazole, posaconazole, amphotericin B inhalation).

 Use of other systemic antifungal activity against Aspergillus (amphotericin, terbinafine, flucytosine, echinocandins, etc.). Therefore it will Fluconazole prophylaxis exclusively.

 Background of IFI proven / probable prior

 Probable IFI / tested at the time of inclusion in the study.

 Exclusion will cause a lack of compliance with the inclusion criteria.

 Patients who have a lack of follow biweekly with galactomannan or PCR. Have a bacterial infection not properly treated and controlled before starting empirical antifungal treatment (according to the definition given above). And finally they have a neutropenia of short duration that it creates a significant risk of IFI. This information will not be known logically to include the patient in the study.

['Aspergillus PCR technique', 'Aspergillus AGA technique']

Aspergillus PCR technique
Aspergillus AGA technique


MEDIHONEY® Gel Versus Collagenase for Wound Debridement

Summary: The purpose of this study is to compare how well two products, Active Leptospermum Honey (ALH) (MEDIHONEY® Gel) and Collagenase (Santyl®), in removing the nonviable (non living) tissue.
Inclusion criteria: inclusion criteria:

 A signed and dated informed consent has been obtained from the subject.

 Subject is able and willing to comply with study procedures.

 Subject is able to comply with weekly visits.

 Subject is 18 years of age or older.

 There is presence of at least 50% or greater necrotic tissue (including slough and eschar) in the wound bed and a total wound surface area of > 1cm2 to < 64cm2.

 Subject will not have currently used parenteral or oral antibiotics except for UTI.

 Diabetic subjects: HbA1c < 12.0 % within 90 days preceding enrollment.

 Pre-albumin greater than 16 mg/dl within 90 days preceding enrollment.

 Subject with a pressure ulcer must be currently receiving adequate pressure redistribution to the affected area via group 2 or 3 specialty bed, a static wheel chair cushion while patient is out of bed.

 Subject with diabetic plantar surface ulcer will use an offloading boot if ambulatory.

 Subject with a venous ulcer must be currently receiving and using compression therapy that can be managed daily.

 Subject and caregiver are trainable and able to perform dressing changes.

 Subject has no allergies to collagenase or honey.

 Subject has no allergies to semi-occlusive or absorptive secondary dressing.

 If subject has multiple wounds only the wound that fits the inclusion criteria will be selected. If more than one wound meets criteria then the largest wound will be selected.

Exclusion criteria: :

 Steroid use >5mg daily.

 Subject is unable to cooperate with offloading and/or compression recommendations.

 ABI = or >0.8 if the wound is located on a lower extremity.

 Wound has the presence of callus requiring sharp or surgical debridement within 3 days prior to randomization and/or needs debridement using any method other than the study agent throughout study treatment.

 Subject has medical instability as deemed by the investigator.

 Subject is pregnant.

 Subject has participated in another clinical trial or wound dressing evaluation in the 30 days prior to enrollment.

['Active Leptospermum Honey (Medihoney)', 'Collagenase']

Active Leptospermum Honey (Medihoney)
Collagenase


The EVICEL® Neurosurgery Phase III Study

Summary: The objective of this study is to evaluate the safety and efficacy of EVICEL® Fibrin Sealant (Human) for use as an adjunct to sutured dural repair in cranial surgery.
Inclusion criteria: inclusion criteria:

 Subjects ≥18 years of age undergoing craniotomy/craniectomy for pathological processes in the supratentorial region or posterior fossa

 Subjects or legally authorized representatives must be willing to participate in the study and provide written informed consent.

 Surgical wound classification Class I

 The cuff of native dura along the craniotomy edge on each side is adequate, based on surgeon's judgment, to facilitate suturing and to allow for sufficient surface area for adherence of the investigational product

 Presence of intra-operative cerebrospinal fluid (CSF) leakage following primary dural closure or after Valsalva maneuver

Exclusion criteria: :

 Subjects with a dural lesion from a recent surgery that still has the potential for CSF leakage.

 Chemotherapy within 30-days prior to enrollment or scheduled within 7-days following surgery

 Radiation therapy to the head within 30-days prior to enrollment or scheduled within 7-days following surgery

 A previous craniotomy/craniectomy within 6 months prior to the study surgery.

 Known hypersensitivity to the components of the investigational product.

 Subjects with a known allergy to FD&C Blue #1 dye

 Subjects with an infection present at the surgical site

 Subjects with an infection indicated by any one of the following: clinical diagnosis of infection, fever, positive urine culture, positive blood culture, positive chest X-ray.

 Female subjects of childbearing potential with a positive pregnancy test or intent to become pregnant during the clinical study period.

 Female subjects who are nursing.

 Exposure to another investigational drug or device clinical trial within 30 days prior to enrollment or anticipated in the 60 day follow-up period.

 Subjects with severely altered renal or hepatic function, with a compromised immune system or autoimmune disease who can NOT receive hydrogel sealant.

 Subjects with penetratring traumatic injuries to the head with damage to the dura

 Dural injury during craniotomy/craniectomy that cannot be eliminated by widening the craniotomy/craniectomy to recreate the native dural cuff.

 Patient has a gap between durotomy edges of greater than 2mm after primary dural closure.

 Approaches that would not allow sutured dural closure such as trans-sphenoidal or trans-labirinthine-/petrosal/-mastoid. Superficial penetration of mastoid air cells are allowed.

 Use of implants made of synthetic materials coming into direct contact with dura

 Use of other fibrin sealants or PEG-based sealants on the dural closure. Approved fibrin sealants may be used for hemostasis if not in contact with the dura.

 Hydrocephalus, except occlusive hydrocephalus caused by posterior fossa pathology or incompletely open cerebrospinal fluid pathways, to be treated during surgical procedure.

 Placement of Gliadel Wafers

 Intersecting durotomy scars in the surgical path from a previous operation that cannot be completely removed by the planned dural resection.

 Two or more separate cranial dural defects, including defects from ventricular cannulation and ventriculo-peritoneal shunting.

 Subjects with any other intra-operative findings identified by the surgeon that may preclude the conduct of the study procedure.

 Confined bony structures where nerves are present where neural compression may result due to swelling.

['EVICEL Fibrin Sealant', 'Hydrogel sealant']


Sleepiness and the Risk of Falling

Summary: The purpose of this project is to examine the impact of sleeping pills and waking up in the middle of the night on walking balance and cognitive function, to identify risk factors for falls in older adults. A significant percentage of falls, approximately 33 to 52 percent, occur during the nighttime and morning hours when people are normally sleeping; therefore, it is possible that sleep and sleeping medication related impairments in balance may contribute to this risk.
Inclusion criteria: inclusion criteria:

 Males and females

 Aged 18 to 35, or 60 to 85

 Lived at Denver altitude or higher for at least one year

 Stable treated diseases: thyroid dysfunction (including hypothyroidism and hyperthyroidism), hypertension, hypercholesterolemia, urinary incontinence, prostate enlargement, gastroesophageal reflux disease, irritable bowel syndrome

Exclusion criteria: :

 Aged 36 to 59, under 18, or over 85

 BMI less than 18.6 or greater than 30 kg/m2, women below 95 pounds regardless of BMI

 Sleep duration is less than 5 or more than 9 hours

 Sensitivity to sleeping medications

 Night work in the preceding 6 months

 Transmeridian travel (across more than 2 time zones) in the last 1 month

 Bone mineral density DXA T-score of less than -1.75

 Orthostatic intolerance

 Prior history of falls in past year

 Prior history of injurious fall in past 5 years

 Hip fracture following a fall

 Difficulty rising from a sitting position without use of hands to push off

 Needing to walk slowly or with a wide base of support to maintain balance

 Hormone replacement therapy for less than 3 months

 Connective Tissue and Joint Disorders

 Neurologic Disorders

 Musculoskeletal Disorders

 Immune Disorders

 Sleep Disorders

 Chronobiologic Disorders

 Cardiovascular Disorders

 Respiratory Disorders

 Kidney and Urinary Tract Disorders

 Infectious Diseases

 Gastrointestinal Disorders

 Hematopoietic Disorders

 Neoplastic Diseases

 Endocrine and Metabolic Diseases

 Psychopathology

 Dementia

 Drug dependency


Confocal Microscopy of Benign and Malignant Skin Tumors

Summary: The investigators speculate that this tool may be used as an alternative and convenient non-invasive diagnostic of skin cancer.
Inclusion criteria: inclusion criteria:

 Men and women over the age of 18

 Skin lesion suspected to either BCC or SCC etc

 Patient was referred for biopsy diagnostic/therapeutic before hand, and regardless of confocal microscope examination, according to the clinical consideration of physician

Exclusion criteria: :

 Pregnant women

 Children


Diagnosing Invasive Aspergillosis by Polymerase Chain Reaction (PCR) Based Investigation of Bronchoalveolar Lavage Samples During Antifungal Therapy

Summary: Invasive pulmonary aspergillosis (IPA) remains a major cause for morbidity and mortality in patients (pts) with hematologic malignancies. As culture-based methods only yield results in a minority of patients, using non-culture-based methods for detection of aspergillosis in clinical specimens becomes increasingly important. Analyzing bronchoalveolar lavage (BAL) samples with polymerase chain reaction (PCR) is promising, however, the influence of current antifungal drugs on the performance of this diagnostic tool remains controversial.~The aim of the trial is to elucidate on the performance of BAL PCR under antifungal treatment.
Inclusion criteria: inclusion criteria:

 immunocomprimised patients with high risk of invasive aspergillosis and lung infiltrates

 informed consent

Exclusion criteria: :

 Children under the age of 5 years

 Informed consent not available


Treatment for Depressed, Obese Individuals at Risk for Cardiovascular Disease (CVD)

Summary: To determine whether individuals who suffer from depression and obesity are able to lose weight and show improvements in mood and cardiovascular disease risk factors following 20 weeks of a combined treatment of cognitive-behavior therapy for depression and behavior modification for weight loss. Participants will be assigned to one of three treatments: 1) cognitive-behavior therapy for the treatment of depression combined with an alternative approach to weight loss, 2) a weight loss intervention combined with a depression support and education , or 3) cognitive-behavioral therapy for depression combined with a weight loss intervention.
Inclusion criteria: inclusion criteria

 Female and male participants, with a BMI of 27 kg/m2 to 45 kg/m2

 Age 18 - 70 years old

 Presence of current major depressive disorder or dysthymic disorder

 At least 2 CVD risk factors, as characterized by the metabolic syndrome, including:

 Elevated waist circumference (males 40 inches or 102 cm; females 35 inches of 88 cm)

 Fasting blood glucose 100 mg/dL

 Blood pressure 130/85 mm Hg

 Triglycerides 150 mg/dL

 Reduced HDL cholesterol (males 40 mg/dL; females 50 mg/dL)

 OR medications for these conditions

 Able to comply will all study procedures and schedule

 Able to speak and read English

Exclusion criteria:

 Cardiovascular event (e.g., myocardial infarction, stroke) within the past 12 months

 Use of tricyclic anti-depressants, monoamine oxidase inhibitors or paroxetine, mood stabilizers, or antipsychotic medications. (Note: participants who take SSRI/SNRI may be acceptable, provided they have been on a stable dose of these medications 3 months.)

 Use of weight-loss medications or any medications known to significantly affect weight (e.g., oral steroids) in past 3 months

 Weight loss of 5% or more in past 6 months

 Enrollment in weight reduction program in prior 3 months

 Treatment in individual psychotherapy for any psychiatric disorder in prior 3 months (Note: participants in couples or family counseling will be allowed.)

 Severe depression or severe impairment of functioning as judged by the assessor or PI

 Presence of active suicidal ideation

 Diabetes

 Alcohol/drug abuse/dependence

 Renal/hepatic disease

 Change in thyroid medications in last 3 months

 Pregnant/lactating, within 6-months post-partum

 Current diagnoses, or history within the last 5 years, of anorexia or bulimia

 Psychotic symptoms or hospitalization for a psychiatric disorder in previous 12 months

 Mood disorder NOS, substance-induced mood disorders, mood disorders due to a general medical condition

 History of bipolar disorder

 History of head trauma

 Any changes in smoking behavior in prior 3 months (or plans to change in the next 3 months)

 Plans for bariatric surgery

 Any other uncontrolled major medical problems

 Women who are pregnant

['Behavior Modification for Weight Loss', 'Alternative Approach to Weight Loss', 'Cognitive-Behavior Therapy for Depression', 'Depression Support and Education']

['Obesity', 'Major Depressive Disorder', 'Dysthymic Disorder', 'Cardiovascular Disease']

Obesity
Major Depressive Disorder
Dysthymic Disorder
Cardiovascular Disease


Treatment of Orthostatic Intolerance

Summary: This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder.
Inclusion criteria: inclusion criteria:

 Chronic symptoms (> 6 months) with standing upright

Exclusion criteria: :

 Obvious cause of hypovolemia or drugs that could worsen tachycardia

 Chronic severe medical conditions such as cancer or ischemic heart disease

['Acetazolamide', 'Atomoxetine', 'NO Drug', 'Clonidine', 'Entacapone', 'Entacapone & Propranolol', 'Atomoxetine & Propranolol', 'Indomethacin', 'Mecamylamine', 'Isosorbide Dinitrate', 'Melatonin', 'Midodrine', 'Modafinil', 'Octreotide', 'Placebo', 'Propranolol', 'Modafinil & Propranolol', 'Sertraline', 'IV Saline', 'Drinking Water', 'Breathing Device', 'memantine', 'Abdominal binder']

Acetazolamide
Atomoxetine
NO Drug
Clonidine
Entacapone
Entacapone & Propranolol
Atomoxetine & Propranolol
Indomethacin
Mecamylamine
Isosorbide Dinitrate
Melatonin
Midodrine
Modafinil
Octreotide
Placebo
Propranolol
Modafinil & Propranolol
Sertraline
IV Saline
Drinking Water
Breathing Device
memantine
Abdominal binder

['Tachycardia', 'Chronic Orthostatic Intolerance']

Tachycardia
Chronic Orthostatic Intolerance


Evaluating Mechanisms of Blood Pressure Reduction Using Meditation in Hypertensive African Americans

Summary: High blood pressure is a common health problem among people in the United States. This study will compare the effectiveness of a meditation program versus a health education program at decreasing stress and lowering blood pressure levels among African-American adults with high blood pressure.
Inclusion criteria: inclusion criteria:

 Self-identifies as African American

 Resides in Washington, DC or surrounding communities

 Has stage I hypertension, defined as systolic blood pressure between 140 and 159 mm Hg and/or diastolic blood pressure between 90 and 99 mm Hg, on average, without taking antihypertensive medications in the sympatholytic class (e.g., beta blockers, alpha antagonists, central nervous system agonists)

Exclusion criteria: :

 Blood pressure levels of less than 140/90 mm Hg or greater than 160/100 mm Hg

 History of clinical cardiovascular disease (e.g., heart attack, angina, intermittent claudication, congestive heart failure, stroke)

 Long-term kidney failure

 Any other life-threatening illness (e.g., advanced cancer)

 History of major psychiatric disorder (e.g., psychosis, dementia, substance abuse disorder)

['Enhanced health education', 'Transcendental Meditation program']

Enhanced health education
Transcendental Meditation program


Vitamin d Levels in Children With Bacterial Meningitis

Summary: The purpose of this study is to determine whether deficiency of Vitamin D has association with outcomes of children with bacterial meningitis.
Inclusion criteria: inclusion criteria:

 Probable bacterial meningitis patients: Clinical manifestation (Any person with sudden onset of fever (> 38.5 °C rectal or 38.0 °C axillary) and one of the following signs: neck stiffness, altered consciousness or other meningeal sign) with cerebrospinal fluid examination showing at least one of the following:

 A. turbid appearance; B.leukocytosis (> 100 cells/mm3); C.leukocytosis (10-100 cells/ mm3) AND either an elevated protein (> 100 mg/dl) or decreased glucose (< 40 mg/dl)

 Confirmed bacterial meningitis patients: A case that is laboratory-confirmed by growing (i.e. culturing) or identifying (i.e. by Gram stain or antigen detection methods) a bacterial pathogen (Hib, pneumococcus or meningococcus) in the cerebrospinal fluid or from the blood in a child with a clinical syndrome consistent with bacterial meningitis

Exclusion criteria: :

 Congenital immunodeficiency patients

 HIV patients

 Patients with corticosteroid treatment for long time

 Patients with disorders in adrenal gland and pituitary gland and hypothalamus

 Patients with tuberculosis


iStride(TM) Device Used for Stroke Rehabilitation

Summary: The objective of this research is to test a passive shoe to correct gait in individuals with asymmetric walking patterns. This will be done in a clinic. Individuals with central nervous system damage, such as stroke, often have irregular walking patterns and have difficulty walking correctly. Recent research has shown that using a split-belt treadmill can create after-effects that temporarily correct the inefficient walking patterns. However, the corrected walking pattern does not efficiently transfer from the treadmill to walking over ground. The iStride, formerly known as the Gait Enhancing Mobile Shoe (GEMS), may allow a patient to practice walking in many different locations, such as their own home, which we hypothesize will result in a more permanent transfer of learned gait patterns. To enable long-term use, our proposed shoe design is passive and uses the wearer's natural forces exerted while walking to generate the necessary motions.
Inclusion criteria: inclusion criteria:

 age 21-80

 one or more cerebral strokes, but all strokes on same side

 a stroke at least 6 months prior to enrollment

 Gait asymmetry, but able to walk independently with or without a cane

 Not currently receiving physical therapy

 no evidence of severe cognitive impairment that would interfere with understanding the instructions

 no evidence of one-sided neglect, affecting ambulation

 At least 25 feet of walking space in home (does not need to be a straight line)

 Weight does not exceed 250 lbs

Exclusion criteria: :

 uncontrolled seizures

 metal implants (stents, clips, pacemaker)

 pregnancy

 History of a neurological disorder other than stroke ( Parkinson's, MS)

 Chronic Obstructive Pulmonary Disease

 Uncontrolled blood pressure

 Head injury in the past 90 days

 A myocardial infarction within the last 180 days

 Cannot rely on a rolling walker for ambulation


Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training

Summary: The purpose of the study is to make a head-to-head comparison of weight loss and interval training as methods of secondary prevention in overweight patients with ischemic heart disease.
Inclusion criteria: inclusion criteria:

 Stable Ischemic Heart Disease

 BMI 28 - 40 kg/m2

Exclusion criteria: :

 Known Diabetes Mellitus

 Repeated Fasting plasma glucose ≥ 7 mmol/L or Hba1c > 7 %

 Severe or moderate valve disease

 Main stem stenosis

 Severe heart failure, Ejection Fraction < 35 %

 Physical or mental disability which are expected to prevent completion of intervention

 Severe Chronic obstructive Pulmonary Disease (COPD) (FEV1 < 50 % of expected) or asthma

 Active cancer

 Severe kidney (GFR < 40 ml/hour) or severe liver disease

 Severe ischemia or arrhythmias during exercise test

 2. or 3. degree atrio-ventricular (AV) block, not protected by pacemaker

 Organised training more than 2 times a week prior to inclusion

 Significant weight loss or weight gain (> 5 %)3 month prior to inclusion

 Not able to comprehend written and oral informed consent

 Hormone treatment


Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage

Summary: The aim of study is to evaluate whether Doppler ultrasound can accurately identify patients who are at risk of recurrent bleeding, who will require endoscopic therapy, and who will fail endoscopic therapy.
Inclusion criteria: inclusion criteria:

 Clean base ulcer with severe upper GIB (defined as melaena, hematochezia, hematemesis, and/or gross blood in NG lavage), and any one of the following:

 SBP ≤ 90mmHg; P of ≥110 bpm; or orthostatic changes with SBP drops 20mmHg or P increases 20 bpm; or,

 Transfusion of 2 or more units of packed red blood cells within 12 hrs of admission; or,

 A documented HCT drop of at lest 6% from baseline.

 Endoscopically confirmed bleeding from GU, DU, pyloric ulcer, or anastomotic ulcer

 Pt can either have primary or secondary acute UGI haemorrhage

Exclusion criteria: :

 Bleeding site from lesion other than GU, DU, pyloric or anastomotic ulcer

 there is more than one type of significant bleeding lesion

 Documented hx of cirrhosis / portal HT

 ESRF requiring any form of dialysis

 Expected or persistent (>24hrs) coagulopathy with INR> 1.5

 Platelet count is under 50000/mm3

 Aspirin User / Plavix [Clopidogrel] User

 If the ulcer is neoplastic

 Cannot obtained consent

 Age < 18 or is pregnant

 Severe comorbid of which life expectancy <30 days


Ultra Structure Of Peritoneum At Electronic Microscopy In Control Subjects And Patients With Gastric Cancer

Summary: Peritoneal metastases appear in a great proportion of patients affected by gastric carcinoma. Involved mechanisms are poorly understood though experimentally it has been demonstrated that neoplastic cells exfoliated from primary tumor can only implant and proliferate in areas of damaged peritoneum. Objectives: to study ultra-structure of peritoneal surface by electronic microscopy in control subjects and in patients with early or locally advanced gastric cancer looking for spontaneous changes in peritoneal surface not related with surgical injury.
Inclusion criteria: inclusion criteria:

 patients with operable local gastric adenocarcinoma

Exclusion criteria: :

 previous abdominal surgery

 previous open or blunt abdominal trauma

 history of inflammatory bowel disease or Typhoid Fever, Gallstone disease, chemotherapy or radiotherapy, or any other abdominal condition that could alter peritoneal integrity.

 All other gastric malignancies such as lymphomas, GIST, carcinoids


Identification of Risk Factors of Prolonged Wound Healing Following Primary Arthroplasty

Summary: Prolonged wound drainage following total joint replacement surgery has been shown to be a predictor of postoperative infection. Several factors have been associated with delayed wound healing and increased risk of infection. Namely hypertension, obesity, diabetes, smoking and autoimmune disease have been shown to have a detrimental effect on wound healing. The purpose of this study is to verify those findings and determine additional pharmacological, surgical and patient related factors that may result in prolonged wound drainage, prolonged hospital stay and increased risk of infection
Inclusion criteria: inclusion criteria:

 All patients receiving primary hip or knee arthroplasty at Hvidovre Hospital from january 2012 to january 2014.

Exclusion criteria: :

 Not willing to participate.

 Drop out at 3 week follow up.

['Evaluate Surgical, Medical and Pharmacological Factors Influence on Wound Healing Following Primary Arthroplasty Surgery']


Intravenous Ferric Carboxymaltose (Ferinject®) With or Without Erythropoietin in Patients Undergoing Orthopaedic Surgery

Summary: Study Design: Single-centre, block randomised, blinded, controlled, phase IIIb, parallel group pilot study.~Primary Objective:~• To evaluate the effect of the administration of ferric carboxymaltose (Ferinject®) with or without erythropoietin vs. no treatment (standard therapy) on the preoperative anaemia status in patients undergoing orthopaedic surgery~Secondary Objective:~To gain informations for the design of a possible follow-up study~To evaluate the effect of the administration of ferric carboxymaltose (Ferinject®) with or without erythropoietin vs. no treatment (standard therapy) on pre- and postoperative Hb levels, iron status, transfusion rate, days until discharge.~To evaluate the tolerability and safety of Ferinject®~Study Centres:~This is a single centre study~Patients:~A total of 75 completed patients (50 patients in the intravenous iron treatment groups and 25 patients in the no treatment group will be recruited.
Inclusion criteria: inclusion criteria:

 > 18 years of age and signed written informed consent

 Patients scheduled to undergo major orthopaedic surgery (hip or knee arthroplasty or back surgery)

 10 g/dl < Hb < 13.0 g/dl for men and 10 g/dl < Hb < 12.0 g/dl for women, at screening ( 3 weeks prior to surgery)

 Ferritin < 100 μg/l or 100-300 with TSat < 20%

Exclusion criteria: :

 Suspicion of iron overload (Ferritin >300 μg/l or/and TSAT>50%)

 Active severe infection/inflammation (defined as serum CRP > 20 mg/l) or diagnosed malignancy

 Folate-and/or Vitamin B12 deficiency (according to local lab reference range)

 Known history of hepatitis B/C or HIV-positive

 Liver values 3 times higher than normal

 Immunosuppressive or myelosuppressive therapy

 A concurrent medical condition(s) that, in the view of the investigator, would prevent compliance or participation or jeopardize the health of the patients.

 Pregnancy or lactation

 Transfusion within 1 month prior to study inclusion, EPO treatment with in the last 4 weeks, any iron treatment within 4 weeks prior to the inclusion in the trail

 Participation in any other therapeutic trial within the previous month

 History of thromboembolic events in the family or the patient

 Severe peripheral, coronary or carotid artery disease

 Bodyweight < 50 kg

 Patients not able to understand the German language


Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Perennial Allergic Rhinitis (PAR)

Summary: Primary Objective:~- To evaluate safety (4 weeks)~Secondary Objectives:~To evaluate the long-term safety (12 weeks)~To evaluate the efficacy~To characterize the pharmacokinetic profile
Inclusion criteria: inclusion criteria:

 Aged 6 months through 11 years

 Patients with perennial allergic rhinitis

Exclusion criteria: :

 Neither serum specific IgE antibody or skin reaction is positive for the antigen of perennial allergy.

 Nasal symptom score is 0 for either sneezing or nasal discharge, or sum of these two score is less than 3, or nasal congestion score is 4.

 Patients with vasomotor rhinitis or eosinophilic rhinitis.

 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Vaccine Therapy With or Without Recombinant Interleukin-12 Followed by Daclizumab in Treating Patients With Metastatic Melanoma

Summary: This randomized phase II trial is studying how well giving vaccine therapy together with or without recombinant interleukin-12 followed by daclizumab works in treating patients with melanoma that has spread to other places in the body. Vaccines made from peptides or antigens may help the body build an effective immune response to kill tumor cells. Recombinant interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating white blood cells to kill melanoma cells. Monoclonal antibodies, such as daclizumab, may decrease the number of regulatory T cells (T cells that suppress the activation of the immmune system) and may lead to a better immune response against melanoma. It is not yet known whether vaccine therapy is more effective with interleukin-12 and daclizumab in treating melanoma.
Inclusion criteria: inclusion criteria:

 Patients must have histologically confirmed melanoma with evidence of metastatic disease either by radiologic or physical examination

 In-transit metastases are allowed

 Biopsy should be performed to reconfirm the diagnosis in cases of doubt

 Patients must have measurable disease

 For computed tomography (CT) imaging, this is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan

 For cutaneous lesions, these must be measurable with a ruler and documented photographically with a ruler in place

 There are no limits on the number of prior therapies; patients must not have received a vaccine containing any of the melanoma antigen peptides, nor previously received daclizumab; at least 4 weeks must have passed since prior chemotherapy or radiation therapy (6 weeks for BCNU [carmustine] or mitomycin C)

 Life expectancy greater than or equal to 12 weeks

 Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky ≥ 80%)

 Leukocytes ≥ 3,000/mcL

 Absolute neutrophil count (ANC) ≥ 1,500/mcL

 Hemoglobin ≥ 9 g/dL

 Platelets ≥ 100,000/mcL

 Creatinine ≤ 1.5 x upper limit of normal (ULN)

 Total bilirubin ≤ 1.5 x ULN

 Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) ≤ 2 x institutional ULN

 Lactate dehydrogenase (LDH) < 1.25 x ULN

 Human leukocyte antigen (HLA) typing: patient must express HLA-A2, either by flow cytometry or by standard HLA typing

 Patient must agree to undergo biopsy of accessible tumor before and after therapy, when feasible, to study tumor cell properties and characteristics of immune cells; if a biopsy cannot be done, then a prior pathologic specimen from the patient must show tumor cells that are positive for melanosome specific antigen (HMB45) and MLANA (MelanA); the tumor must express at least 2 antigens in the vaccine for the patient to be eligible

 Women of child-bearing potential and men must agree to use adequate contraception (hormonal, barrier method of birth control, or abstinence) prior to study entry, for the duration of treatment, and for 2 months after completion of treatment; a pregnancy test must be done and be negative for women of child-bearing potential; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

 Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria: :

 Patients who have had chemotherapy, biological or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier

 Patients may not be receiving any other investigational agents

 Presence of untreated brain metastases; all patients must undergo brain imaging as part of the pre-study evaluation; only patients with no brain metastases, or with brain lesions successfully treated by stereotactic radiation or surgical removal without progression at 28-day follow-up and off corticosteroids for 4 weeks, will be eligible

 History of allergic reactions attributed to compounds of similar chemical or biologic composition IL-12 or other agents used in the study

 Concurrent systemic corticosteroids (except physiologic replacement doses) or other immunosuppressive drugs (eg. cyclosporin A)

 Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

 Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with IL-12; women of child-bearing age must be tested for urinary or serum beta-human chorionic gonadotropin (HCG)

 Patients with intrinsic immunosuppression, including seropositivity for human immunodeficiency virus (HIV) antibody; patients should be tested for HIV; HIV-positive patients are ineligible

 Psychiatric illness that may make compliance to the clinical protocol unmanageable or may compromise the ability of the patient to give informed consent; patients with clinical evidence of dementia should have a competent designee participate in decision making

 Serious concurrent infection, including active tuberculosis, hepatitis B, or hepatitis C; patients should be tested for hepatitis B surface antigen and hepatitis C antibody; patients who are hepatitis C antibody (Ab) positive can be eligible if they are polymerase chain reaction (PCR)-negative

 Active or history of autoimmune disease including but not limited to: rheumatoid arthritis (rheumatoid factor [RF]-positive with current or recent flare), inflammatory bowel disease, systemic lupus erythematosis (clinical evidence with antinuclear antibody [ANA] 1:80 or greater), ankylosing spondylitis, scleroderma, multiple sclerosis, autoimmune hemolytic anemia, and immune thrombocytopenic purpura; seropositivity alone will not be considered active autoimmunity; patients with immune-mediated hypothyrodisim and/or vitiligo are allowed

 Active gastrointestinal bleeding or uncontrolled peptic ulcer disease

['NA17.A2 Peptide Vaccine', 'Recombinant MAGE-3.1 Antigen', 'Recombinant Interleukin-12', 'MART-1 Antigen', 'Laboratory Biomarker Analysis']

NA17.A2 Peptide Vaccine
Recombinant MAGE-3.1 Antigen
Recombinant Interleukin-12
MART-1 Antigen
Laboratory Biomarker Analysis

['Recurrent Melanoma', 'Stage IV Skin Melanoma']

Recurrent Melanoma
Stage IV Skin Melanoma


Levothyroxine in Pregnant SLE Patients

Summary: The last two decades have witnessed an explosion of new research documenting the deleterious impact that thyroid disease has on pregnancy and the postpartum period, in relation to miscarriage preterm delivery intelligence quotient of the unborn child and health of the mother postpartum. Both subclinical hypothyroidism and thyroid antibody positivity in euthyroid women have been associated with miscarriage and preterm delivery. Approximately 5% of all pregnant women have a thyroid disorder. both spontaneous miscarriage and preterm delivery.~Systemic lupus erythematosus (SLE), an autoimmune disorder of unknown etiology, has also been documented to negatively impact pregnancy. Women with Systemic lupus erythematosus (SLE)have increased rates of miscarriage and preterm delivery. Women with Systemic lupus erythematosus (SLE) also have increased rates of hypothyroidism and autoimmune thyroid disease (AITD, defined as the presence of thyroid antibodies with or without thyroid dysfunction). Preterm delivery (PTD), defined as birth prior to 37 weeks gestation, is the leading cause of neonatal mortality and morbidity in the United States. Although risk factors for preterm delivery exist, the majority of women have no known risk factors. Recently, both hypothyroidism and autoimmune thyroid disease have also been linked to preterm delivery. Given the increased prevalence of negative outcomes documented in pregnant women with thyroid disease, and the increased rates of hypothyroidism and Autoimmune thyroid disease in women with Systemic lupus erythematosus (SLE), the investigators determined that Autoimmune thyroid disease was associated with both preterm delivery and miscarriage. This has led to this application to begin a pilot randomized clinical trial of thyroxine in autoimmune thyroid disease in systemic lupus erythematosus pregnancy.
Inclusion criteria: inclusion criteria:

 All SLE (Systemic Lupus Erythematosus) pregnant women (aged 18 - 45 years) before 14 weeks of gestation, with autoimmune thyroid antibodies

Exclusion criteria: :

 SLE (Systemic Lupus Erythematosus) patients already on levothyroxine. Those patients discovered to be hypothyroid who need levothyroxine as part of standard of care


A Trial of Doxorubicin/Cyclophosphamide (AC), Docetaxel (D), and Alternating AC and D for Metastatic Breast Cancer

Summary: To investigate the clinical benefits of Docetaxel or alternating AC-Docetaxel in comparison with standard AC for metastatic breast cancer
Inclusion criteria: inclusion criteria:

 Hormonal therapy-resistant MBC

 ER (-), failure of hormonal therapy for MBC, or relapse within 6 months after adjuvant hormonal therapy

 No anthracyclines for MBC and no prior taxanes

 At least 6 months from the completion of adjuvant chemotherapy

 Measurable or evaluable lesions

 Age: 20 to 75 years

 PS: 0-3

 WBC >= 4,000 /mm3 or ANC >=1,000 /mm3, Platelet >= 100,000 /mm3, SGOT/SGPT <= 1.5 x ULN, T-Bil <= 1.5 mg/dL, Cr <= 1.5 mg/dL

 normal ECG

 Written informed consent

Exclusion criteria: :

 pregnant

 malignant pleural effusion, ascites, or pericardial effusion that requires emergent treatment

 Active infection

 other cancer present within the last 5 years

 previous stem cell transplantation

 brain metastasis that requires emergent treatment

 relapse within 6 months after completion anthracycline or during anthracycline

 more than 250mg/m2 of anthracyclines

 hypersensitivity of drug

 interstitial pneumonitis or pulmonary fibrosis

 positive HBs

 antipsychotic medication

 doctor's judgement

['AC (ADM 40mg/m2+CPA 500mg/m2) q21 days x 6 cycles', 'Docetaxel 60mg/m2 every 21 days for 6 cycles', 'AC and Docetaxel 60mg/m2 alternately q21 days for 6 cycles']

['Breast Cancer', 'Neoplasm Metastasis']


Evaluation of the IND One Step Strep A Rapid Test vs. Culture

Summary: The purpose of this study is to demonstrate the ability of the IND One Step Strep A test to accurately test a throat swab specimen from a symptomatic patient for the presence or absence of Group A Streptococcus (Strep A) when compared to culture.
Inclusion criteria: inclusion criteria:

 Male and Female subjects three (3) years of age or older

 Patients exhibiting at least 3 of the following symptoms:

 fever

 sore throat

 swollen lymph nodes in the neck

 redness of the throat and tonsils

 white or yellow patches on the tonsils

 Must be able to collect 2 throat swab samples from patient

Exclusion criteria: :

 Patients currently undergoing antibiotic treatment will be excluded from study


Spinal Anesthesia for Cesarean Delivery is Associated With Decreases in Regional Cerebral Oxygen Saturation as Assessed by Near- Infrared Spectroscopy

Summary: The cerebral oxygen saturation is assessed by means of near-infrared spectometry in parturients undergoing cesarean delivery under spinal anesthesia. The investigators hypothesis was that spinal anesthesia does not influence cerebral oxygen saturation.
Inclusion criteria: inclusion criteria:

 Term healthy parturients

Exclusion criteria: :

 Body Mass Index > 35

 preeclampsia

 neurological,cardiovascular, respiratory disease

['Spinal Anesthesia with cerebral oxygen saturation monitoring']

['Cerebral Oxygen Saturation During Spinal Anesthesia for Cesarean Delivery']


Effects of Carvedilol on Health Outcomes in Heart Failure

Summary: The purpose of our study was to determine if a strategy of starting a heart medication (Beta-blocker) before patients leave the hospital and then being seen by a nurse manager would reduce subsequent hospitalizations compared to usual care.~Hypothesis: A nurse-directed heart failure management program with inpatient initiation of beta blockers will improve health outcomes in a vulnerable, predominantly Hispanic and African American population.
Inclusion criteria: inclusion criteria:

 primary hospitalization with heart failure and LVEF < 40%

 patient informed consent has been obtained

 absence of pulmonary congestion

 age > 18 years

Exclusion criteria: :

 End-stage renal or hepatic disease

 Acute myocardial infarction as primary diagnosis during index hospitalization

 Life-expectancy < 6-months

 Contraindication to beta blocker use

 Current beta-blocker therapy

 Planned bypass or valve surgery during index hospitalization


Study to Compare Lefamulin to Moxifloxacin (With or Without Linezolid) for the Treatment of Adults With Pneumonia

Summary: This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment of adults with moderate to severe community-acquired bacterial pneumonia.
Inclusion criteria: inclusion criteria:

 Be male or female at least 18 years of age.

 Provide written informed consent and be willing and able to adhere to the study-specified procedures and restrictions.

 Have an acute illness (7 days duration) with at least 3 of the following symptoms consistent with a lower respiratory tract infection (new or worsening):

 Dyspnea

 New or increased cough

 Purulent sputum production

 Chest pain due to pneumonia

 Have at least 2 of the following vital sign abnormalities:

 Fever (body temperature >38.0°C (100.4°F) measured orally or equivalent temperature from an alternate body site) or hypothermia (body temperature <35.0°C (95.0°F) measured orally or equivalent temperature from an alternate body site)

 Hypotension (systolic blood pressure <90 mmHg)

 Tachycardia (heart rate >100 beats/min)

 Tachypnea (respiratory rate >20 breaths/min)

 Have at least 1 other clinical sign or laboratory finding of CABP:

 Hypoxemia (i.e., O2 saturation <90% on room air or while receiving supplemental oxygen at subject's baseline requirement or PaO2 <60 mmHg)

 Auscultatory and/or percussion findings consistent with pneumonia (e.g., crackles, egophony, dullness)

 White blood cell (WBC) count >10,000 cells/mm3 or <4500 cells/mm3 or >15% immature neutrophils (bands) regardless of total WBC count

 Have radiographically-documented pneumonia within 48 hours before enrollment (i.e., infiltrates in a lobar or multilobar distribution or diffuse opacities on chest x-ray or chest computed tomography scan consistent with acute bacterial pneumonia).

 Have a Pneumonia Outcomes Research Team (PORT) Risk Class ≥III.

Exclusion criteria: :

 Have received more than a single dose of a short-acting oral or IV antibacterial for CABP within 72 hours before randomization

 Require concomitant systemic antibacterial therapy potentially effective against CABP pathogens

 Have been hospitalized for 2 or more days within 90 days prior to the onset of symptoms or have resided in a nursing home or long-term healthcare facility within 30 days prior to the onset of symptoms. NOTE: Residence in an independent living facility is permitted.

 Have confirmed or suspected CABP caused by a pathogen known to be resistant to any of the study drugs (e.g., Pseudomonas aeruginosa, any pathogen of the Enterobacteriaceae Family) or attributable to etiologies other than community acquired bacterial pathogens (e.g., ventilator associated pneumonia, hospital acquired bacterial pneumonia, bacterial aspiration pneumonia, Pneumocystis jiroveci pneumonia or other fungal pneumonia, viral or mycobacterial infection of the lung).

 Have a noninfectious cause of pulmonary infiltrates (e.g., pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure, bronchial obstruction, lung cancer, cystic fibrosis).

 Have confirmed or suspected pleural empyema (does not include sterile parapneumonic effusions).

 Require mechanical ventilation.


Family-Based Mindful Eating Intervention for Overweight Adolescents

Summary: With currently 35% of U.S. adolescents being overweight and one in six having metabolic syndrome, adolescent obesity is one of the major global health challenges of the 21st century. Few enduring treatment strategies have been identified in adolescent populations and the majority of standard weight loss programs fail to adequately address the impact of psychological factors on eating behavior and the beneficial contribution of parental involvement in adolescent behavior change. A critical need exists to expand treatment development efforts beyond traditional education and cognitive-behavioral programs and to explore alternative treatment models for adolescent obesity. Meditation-based mindful eating programs may represent a unique and novel scientific approach to the current adolescent obesity epidemic as they address key psychological variables affecting weight. Furthermore, the recent expansion of mindfulness programs to include family relationships shows the immense potential for broadening the customarily individual focus of this intervention to include broader factors thought to influence adolescent health outcomes. Thus, we propose to develop a mindful eating approach to eating behavior and weight loss specifically tailored for adolescents and their families. The first phase of our three phase development process will be devoted to adapting an adolescent protocol (Mindful Eating-A) based on an established mindful eating program currently being used with adult populations. We will then develop a 'family enhanced Mindful Eating-A' (Mindful Eating-A+F) protocol that integrates a family systems perspective. The goal of Mindful Eating-A+F is to expand the focus of Mindful Eating-A to include family factors that influence adolescent eating behaviors. The second design phase will consist of an initial test of both intervention components to provide feedback on usefulness and acceptability (N = 10 families). The final phase will examine the overall efficacy of the optimized Mindful Eating-A+F, relative to the Mindful Eating-A intervention with 30 overweight adolescents (BMI > 85th percentile) ages 14-17 and at least one parent. Within this examination, post-treatment and 3-month follow-up comparisons across the two treatment approaches will be made and effect sizes within and between treatments will be assessed.
Inclusion criteria: inclusion criteria:

 Adolescent ages 14-17 years old living at home with at least one parent/guardian,

 BMI ≥ 85th percentile,

 assent from adolescent,

 consent from a parent/guardian,

 willingness of one parent/guardian living with adolescent to participate in the study,

 English speaking.

Exclusion criteria: :

 Adolescent BMI ≥ 40 (requires additional medical attention the intervention is unable to provide),

 previously diagnosed type 1 or type 2 diabetes,

 blood pressure in the range of stage 2 hypertension which requires medication

 treatment which interferes with outcomes related to blood pressure and glucose,

 medications that significantly interfere with weight gain such as oral steroid use greater than two consecutive weeks

 antipsychotic medications,

 participation in a standardized weight loss program within the previous 6 months,

 inability to provide informed assent,

 no parent/guardian consent,

 insufficient reading ability to comprehend the self-administered assessment instruments (approximately 5th grade reading level).

['Adolescent Mindful Eating Group', 'Parent Integrated Group']

Adolescent Mindful Eating Group
Parent Integrated Group

['Overweight', 'Adolescent Behavior', 'Family Research', 'Weight Loss']

Overweight
Adolescent Behavior
Family Research
Weight Loss