Incidence and Spectrum of Acute Kidney Injury in Cirrhotics and Assessment of New Biomarkers as Early Predictors of Acute Kidney Injury

Summary: 500 patients with normal renal function will be prospectively studied and incidence, spectrum and natural history of AKI (Acute Kidney Injury) will be observed in them and in 200 patients with abnormal renal function fulfilling AKI (Acute Kidney Injury) criteria will be prospectively studied for 1 year. Also biomarkers will be studied and validated as early predictors of AKI (Acute Kidney Injury).
Inclusion criteria: inclusion criteria:

 - Group A: 500 patients of cirrhosis with normal baseline renal function will be enrolled Group B : 200 patients who present with AKI (Acute Kidney Injury) will be enrolled

Exclusion criteria: :

 Age < 18 or > 70 years

 Preexisting Chronic Renal Disease

 Patients with obstructive uropathy.

 Cirrhosis with HCC (HepatoCellular Carcinoma).

 Advanced cardiopulmonary disease

 Pregnancy

 Patients with extrahepatic malignancy


Comparative Study of the Use of Beta Blocker and Oral Corticosteroid in the Treatment of Infantile Hemangioma

Summary: Infantile Hemangioma (IH) is infancy's most common vascular tumor of infancy and most frequent benign neoplasm.~Treatment of IHs is indicated for approximately 10 to 20% of the cases. Two groups can be defined amongst indications for treatment: patients with absolute indication for treatment and patients with relative indication for treatment.~Absolute or emergency indications comprise function or life threatening situations such as obstruction of airways, obstruction of vision, congestive heart failure, hepatic and coagulation problems.~The following are considered relative indications: cases of large and disfiguring facial hemangiomas; locations that can result in a deformity and/ or permanent scar (nose, ear, lip, glabellar area); extensive face hemangiomas, mainly when there is dermal damage (more probable to scar); local complications such as ulceration, infection and bleeding as well as small hemangiomas in exposed areas (hands and face), mainly if pedunculated due to its ease of excision2,7.~Treatment modalities vary according to the extension, location, presence of complications and the evolutional phase. A combination of various treatments is possible.~Beta blockers are being used in children for approximately 40 years, with proven clinical safety and no cases of death or cardiovascular disease resulting from its direct use. Recently it was reported the use of beta blockers (propanolol) for IH treatment, with significant reduction of tumor volume after introduction of the beta blocker, in a short period of time, with stable results after the end of treatment, which suggested evidences of the benefits of this drug in the tumor treatment The proposal of this study is to assess the use of propanolol in IH treatment, quantifying its effectiveness and safety under continuous monitoring and comparing it to the use of oral corticosteroid. The investigators propose the assessment of the betablockers' use in comparison to the use of corticosteroids in infants with IH in the proliferative or involuting phases, with indication for clinical treatment, and that are not alarming nor urgent; in other words, the current relative indications for treatment.
Inclusion criteria: inclusion criteria:

 Patients with ages up to 2 years;

 Clinically diagnosed hemangioma, in proliferative or involutive phase, with relative indication for clinical treatment, as itemized:

 lesion causing alteration of regional anatomy with no systemic or functional damage and with a diameter greater than 1 centimeter, or

 lesion causing aesthetic deformity, or

 lesion causing local repetitive complications such as ulceration, bleeding or local infection, or

 lesion causing partial damage of orifices, or

 lesion causing psychological compromise.

 Absence of cardiopathy (normal physical examination, anamnesis, echocardiography, electrocardiography and thoracic radiography);

 Informed consent signed by responsible parties

Exclusion criteria: :

 Hemangioma with absolute indication for treatment, presenting a risk to function or life;

 Patients with previous treatment for infantile hemangiomas;

 Cardiac disease;

 Pulmonary disease (asthma, bronchiolitis,bronchopulmonary dysplasias)

 Raynaud syndrome;

 Pheochromocytoma;

 Altered echocardiography, even if asymptomatic


Pilot Study for the SQUEEZE Trial

Summary: The purpose of the SQUEEZE Trial is to determine which fluid resuscitation strategy results in the best outcomes for children treated for suspected or confirmed septic shock. In this study, eligible children will be randomized to either the 'Usual Care Arm' or the 'Fluid Sparing Arm'. Children will receive treatment according to current ACCM Septic Shock Resuscitation Guidelines, with the assigned resuscitation strategy used to guide administration of further fluid boluses as well as the timing of initiation and escalation of vasoactive medications to achieve ACCM recommended hemodynamic targets.
Inclusion criteria: inclusion criteria:

 inclusion criteria for 1 and 3 must be answered YES to be eligible for study.

 1. Age 29 days to less than 18 years of age

 2a) Patient has Persistent Signs of Shock including one or more of the following: i) Vasoactive Medication Dependence ii) Hypotension (Systolic Blood Pressure and/or Mean Blood Pressure less than the 5th percentile for age) iii) Abnormal Perfusion (2 or more of: abnormal capillary refill, tachycardia, decreased level of consciousness, decreased urine output)

 2b) Suspected or Confirmed Septic Shock (Shock due to Suspected or Confirmed Infectious Cause)

 2c) Patient has received initial fluid resuscitation of: Minimum of 40 mL/kg of isotonic crystalloid (0.9% Normal Saline and/or Ringer's Lactate) and/or colloid (5% albumin) as fluid boluses within the previous 6 hours for patients weighing less than 50 kg, OR Minimum of 2 litres (2000 mL) of isotonic crystalloid (0.9% Normal Saline and/or Ringer's Lactate) and/or colloid (5% albumin) as fluid boluses within the previous 6 hours for patients weighing 50 kg or more

 3. Patient has Fluid Refractory Septic Shock as defined by the Presence of all of 2a, 2b, and 2c.

Exclusion criteria: :

 Patient admitted to the Neonatal Intensive Care Unit (NICU)

 Patient requiring resuscitation in the Operating Room (OR) or Post-Anesthetic Care Unit (PACU)

 Full active resuscitative treatment not within the goals of care

 Shock Secondary to Cause other than Sepsis (i.e. obvious signs of cardiogenic shock, anaphylactic shock, hemorrhagic shock, spinal shock)

 Previous enrolment in this trial, where known by the research team

['Fluid Sparing Resuscitation Strategy']


Erlotinib Compared With Temozolomide or Carmustine in Treating Patients With Recurrent Glioblastoma Multiforme

Summary: RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as temozolomide and carmustine, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether erlotinib is more effective than temozolomide or carmustine in treating recurrent glioblastoma multiforme.~PURPOSE: This randomized phase II trial is studying erlotinib to see how well it works compared to temozolomide or carmustine in treating patients with recurrent glioblastoma multiforme.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Histologically or cytologically confirmed glioblastoma multiforme

 Some oligodendroglial elements allowed provided they make up < 25% of the tumor

 Recurrent disease documented by MRI after prior radiotherapy

 At least 1 bidimensionally measurable target lesion ≥ 2 cm by MRI

 Undergone prior surgery for recurrent primary brain tumor more than 3 months before study entry

 Must have a clearly limited target lesion ≥ 2 cm OR evidence of progressive and measurable target lesion OR a second measurable target lesion outside the surgical area

 PATIENT CHARACTERISTICS:

 Age

 Over 18

 Performance status

 Karnofsky 70-100%

 Life expectancy

 Not specified

 Hematopoietic

 Absolute neutrophil count ≥ 1,500/mm^3

 Platelet count ≥ 100,000/mm ^3

 Hepatic

 AST and ALT < 2.5 times upper limit of normal (ULN)

 Bilirubin < 1.5 times ULN

 Renal

 Creatinine < 1.5 times ULN

 Cardiovascular

 Clinically normal cardiac function

 No ischemic heart disease within the past 12 months

 No New York Heart Association grade III or IV cardiac insufficiency

 No unstable angina

 No arryhthmia

 Pulmonary

 DLCO > 70% of predicted (for patients randomized to receive erlotinib [arm I] or carmustine [arm II])

 No history of pulmonary disease that would affect pulmonary function including any of the following:

 Chronic bronchopneumopathy

 Pleural effusion

 Interstitial pnuemonia

 Pulmonary lymphangitis

 Other

 Not pregnant or nursing

 Negative pregnancy test

 Fertile patients must use effective contraception during and for 3 months after study participation

 No other malignancy except cone biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer

 No psychological, familial, sociological, or geographical factors that would preclude study compliance

 PRIOR CONCURRENT THERAPY:

 Biologic therapy

 No prior HER-targeted agents

 No concurrent growth factors for neutrophil count elevation

 No concurrent epoetin alfa

 Chemotherapy

 Prior adjuvant temozolomide allowed

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

 No more than 1 prior adjuvant chemotherapy regimen

 No prior chemotherapy for recurrent disease

 Endocrine therapy

 Must be on a stable or decreasing dose of corticosteroids for at least 2 weeks before study entry

 Radiotherapy

 See Disease Characteristics

 More than 3 months since prior radiotherapy to the brain

 No prior high-dose radiotherapy (> 65 Gy), stereotactic radiosurgery, or internal radiotherapy unless disease recurrence confirmed

 Surgery

 See Disease Characteristics

 Other

 No prior participation in experimental therapies

 No concurrent CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, troleandomycin, cimetidine, or grapefruit juice)

 No concurrent warfarin or other coumarin derivatives

 Concurrent low-molecular weight heparin allowed

 No other concurrent investigational drugs
Exclusion criteria:

['carmustine', 'erlotinib hydrochloride', 'temozolomide']

carmustine
erlotinib hydrochloride
temozolomide

['Brain and Central Nervous System Tumors']


Incidence of Male Pudendal Artery Stenosis in Suboptimal Erections Study

Summary: The purpose of this study is to determine the proportion of men with known or suspected coronary artery disease (CAD) and/or peripheral arterial disease (PAD) that have angiographic identifiable erectile related artery (ERA) atherosclerotic disease defined as at least one ERA stenosis greater than or equal to 50% (per core lab Quantitative Vascular Analysis - QVA).
Inclusion criteria: inclusion criteria:

 Subject must be undergoing coronary or peripheral angiography for suspected or known coronary or peripheral atherosclerotic disease

 Subject must be male ≥ 35 and ≤ 70 years old

 Subject must provide written informed consent before any study-related procedures are performed

 Subject must agree to comply with study procedures and follow-up for the entire length of the study

Exclusion criteria: :

 Subject is unable to safely attempt sexual intercourse secondary to severe cardiac disease or other health condition

 Subject has a life expectancy of < 12 months

 Subject's serum creatinine is > 2.5 mg/dl

 Subject has known aorto-iliac occlusive disease, previous AAA endograft procedure or open surgical procedure

 Subject has history of prostatic carcinoma requiring surgery (i.e., prostatectomy), pelvic radiation, or hormonal/chemotherapy

 Subject has a history of myocardial infarction, stroke, life-threatening arrhythmia, or unstable angina requiring hospitalization within 3 months (90 days) prior to enrollment

 Subject has had exposure to PDE5 inhibitor (per subject's concomitant medication list) within the 72 hours prior to the scheduled baseline angiography

 Subject has a history of renal transplantation

 Subject has a penile implant

 Subject has become unstable or has received a maximum radiation dose, increased procedure time, and/or maximum contrast dose (in the Investigator's opinion) from the primary angiographic procedure that would compromise the safety of the subject by proceeding with enrollment into the IMPASSE study

['Erectile Dysfunction Due to Arterial Insufficiency']


Efficacy of LAMA Added to ICS in Treatment of Asthma

Summary: The purpose of this study is to evaluate the superiority of the glycopyrrolate bromide (CHF 5259 pMDI) versus placebo on top of QVAR® pMDI, in terms of lung functions parameters, as well as to assess its safety.
Inclusion criteria: inclusion criteria:

 History of asthma ≥ 5 years and diagnosed before 40 years old

 Uncontrolled asthma on low-medium doses of Inhaled CorticoSteroid (ICS) with ACQ (Asthma Control Questionnaire) ≥1.5

 Pre-bronchodilator FEV1 ≥40% and <90% of their predicted normal value

 Positive reversibility test

Exclusion criteria: :

 Pregnant or lactating women

 Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)

 Patients treated for asthma exacerbation in the 4 weeks prior to study entry

 Patients who are in therapy for gastroesophageal reflux disease

 Patients who have a clinically significant cardiovascular condition


GM-CSF and Thalidomide in Treating Patients Undergoing Surgery for High-Risk Prostate Cancer

Summary: RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Thalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. Giving GM-CSF and thalidomide before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.~PURPOSE: This phase II trial is studying how well giving GM-CSF together with thalidomide works in treating patients undergoing surgery for high-risk prostate cancer.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Histologically confirmed adenocarcinoma of the prostate meeting any of the following criteria for high-risk disease:

 Clinical stage II or III (T2b, T2c, or T3 with any grade or prostate-specific antigen [PSA])

 Gleason score 7 (4+3 only) or ≥ 8 (any stage or PSA)

 Serum PSA ≥ 10 ng/dL (any grade or stage)

 Any stage, PSA, or Gleason score with ≥ 35% chance of biochemical failure at 5 years based on Kattan's nomogram

 No clinical evidence of CNS metastases

 No metastatic disease as demonstrated by radiological exam (CT scan, MRI, bone scan, x-ray) within 8 weeks of study entry

 Appropriate medical candidate for radical prostatectomy

 PATIENT CHARACTERISTICS:

 ECOG performance status 0-1

 Creatinine ≤ 2.0 mg/dL

 Granulocyte count ≥ 1,800/mm³

 Platelet count ≥ 100,000/mm³

 AST < 3 times upper limit of normal

 Bilirubin ≤ 1.5 mg/dL

 Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment

 No active unresolved infection

 No pre-existing peripheral neuropathy > grade 1

 No known HIV positivity

 No other malignancy within the past 5 years except curatively treated basal cell or squamous cell carcinoma of the skin or controlled Ta transitional cell carcinoma of the bladder

 No known contraindication to sargramostim (GM-CSF) or thalidomide

 PRIOR CONCURRENT THERAPY:

 No prior radiotherapy to the prostate or pelvis

 No prior chemotherapy or hormonal therapy for prostate cancer

 No parenteral antibiotics within the past 7 days
Exclusion criteria:

['sargramostim', 'thalidomide', 'conventional surgery', 'neoadjuvant therapy']

sargramostim
thalidomide
conventional surgery
neoadjuvant therapy


Effect of Early Mechanical Ventilation to Severe Acute Pancreatitis

Summary: Acute lung injury (ALI) and acute respiratory distress syndrome(ARDS) represent the most common and earliest organ dysfunction in acute pancreatitis, presenting as dyspnea and intractable hypoxemia, with secondary bilateral pulmonary infiltrates on radiograph. And mechanical ventilation (MV) is the essential intervention to improve oxygenation. When to initiate MV remains uncertain. In this study, we aim to compare the effect of early MV and conventional MV, and we hypothesize that early MV may be a better treatment option.
Inclusion criteria: inclusion criteria:

 Diagnosis of pancreatitis:typical pain, increase in serum lipase or amylase, onset of abdominal pain within 72h before admission

 The diagnosis criteria of Severe Acute Pancreatitis is according to Atlanta criteria revisited in 2012

 the diagnosis of ARDS meets the criteria of Berlin definition

Exclusion criteria: :

 chronic respiratory disease as chronic obstructive pulmonary disease (COPD), asthma

 organic cardiopathy

 pregnancy

['early mechanical Ventilation', 'Conventional Mechanical Ventilation']

early mechanical Ventilation
Conventional Mechanical Ventilation

['Acute Pancreatitis', 'Complication of Ventilation Therapy']

Acute Pancreatitis
Complication of Ventilation Therapy


Antibiotics for the Treatment of Ulcerative Colitis

Summary: Ulcerative colitis (UC) is an acute and chronic inflammatory bowel disease, whose cause is unknown. However, it is widely accepted that bacteria living in the large bowel are essential for the development of the disease. Intuitively, therefore, a logical approach to treatment would be to use antibiotics. However, antimicrobial chemotherapy has been unsuccessful in managing acute colitis, and has had only limited benefit in long-term treatment. The failure of antibiotics in UC arises from the fact that no-one has tried to identify which bacteria are involved in causing disease, and equally importantly, nobody has targeted appropriate antibiotics to knock out the specific bacteria in question, in a systematic way. Despite this, increasing evidence implicates bacteria living on the lining of the bowel being involved in UC. Our aim, therefore is to identify bacteria colonizing the mucosal surface in the lower large intestine and to determine the antibiotic sensitivities of those the investigators believe to be particularly involved in the disease, such as enterococcit, peptostreptococci and enterobacteria. Because the investigators have already studied resistance to antimicrobial in many mucosal isolate, the investigators plan ot focus on using a combination of two antibiotics in this work. A controlled trial will test the benefit of using these antibiotics over a period of one month and then the patients will be followed up over a six month period. The investigators will be looking for significant long-term improvements, and a reduction in drug use following antibiotic therapy.
Inclusion criteria: inclusion criteria:

 Active ulcerative colitis, CAI greater than or equal to 4

Exclusion criteria: :

 Antibiotics in the last 3 months

 Probiotics

 Alteration to medications in last 3 months

['Cefuroxime', 'Ciprofloxacin', 'Clarithromycin', 'Cotrimoxazole', 'Coamoxiclav', 'metronidazole', 'neomycin', 'rifaximin', 'Vancomycin', 'Doxycycline']

Cefuroxime Ciprofloxacin Clarithromycin Cotrimoxazole Coamoxiclav metronidazole neomycin rifaximin Vancomycin Doxycycline


CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis

Summary: The purpose of this study is to evaluate the clinical efficacy of blisibimod as measured by a composite responder index in subjects who, despite corticosteroid use, continue to have autoantibody positive, clinically-active Systemic Lupus Erythematosus (SLE) as defined by SELENA SLEDAI score ≥10.
Inclusion criteria: inclusion criteria:

 Fulfill at least 4 diagnostic criteria for SLE defined by American College of Rheumatology

 Positive antinuclear antibodies (ANA) and/or anti-double stranded DNA (anti-dsDNA)

 Active SLE disease as defined by SELENA-SLEDAI score ≥10 despite on-going stable corticosteroid therapy

 Subjects with stable nephritis may be enrolled

 18 years of age or older

Exclusion criteria: :

 Severe active vasculitis, active central nervous system lupus, uncontrolled hypertension or poorly controlled diabetes

 Malignancy within past 5 years

 Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C

 Liver disease

 Anemia, neutropenia, or thrombocytopenia

 Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections

 History of active tuberculosis or a history of tuberculosis infection

 Pregnant or nursing


Impact of the BB Box System on Postpartum Maternal Anxiety, Post Traumatic Stress and Mother-child Relationships

Summary: The main objective of this study is to compare the degree of maternal anxiety at Day 3 postpartum in mothers who did or did not have access to a video communication system (BB-Box system) from the time of initial separation with their baby.
Inclusion criteria: inclusion criteria:

 The patient must have given his/her informed and signed consent

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

 The patient is available for 12 months of follow up

 The patient has given birth this day to a premature child (< 36 weeks of gestation and/or < 2 kg birthweight)

 Separation of child and mother since birth

Exclusion criteria: :

 The patient or baby is participating in another study, excepting the studies OASIS or PROM8736

 The patient or baby is in an exclusion period determined by a previous study

 The patient is under judicial protection, under tutorship or curatorship

 The patient or father refuses to sign the consent

 It is impossible to correctly inform the patient

 Preexisting maternal psychiatric pathology

 Major or lethal poly-malformation syndrome

 Severe pathologies that threaten child survival: pulmonary hypertension, septic shock, anoxic-ischemic brain

 Any emergency situation preventing patient involvement

 Mother and/or child not hospitalized at the Nîmes University Hospital

 Death of the patient or child during the study

['Stress Disorders, Post-Traumatic', 'Anxiety']


How the Elderly Live With Pain in Heart Failure

Summary: The How the Elderly Live with Pain in Heart Failure (HELP-HF) study provides the opportunity to assess the complaints of pain in a cohort of HF patient admitted to Thomas Jefferson University Hospital (TJUH). Additional information on their existing co-morbid conditions, an inventory of their prescribed medications, and details regarding the type of treatment interventions (over the counter analgesia and other comfort practices) they report using will be collected.
Inclusion criteria: inclusion criteria:

 Men and women ≥ 60 years.

 Admission to hospital for worsening HF

Exclusion criteria: :

 History of uncontrolled hypertension.

 Severe valve disease.

 End-stage (Stage D) HF, including treatment with chronic ionotropic drugs or left ventricular assist device support.

 Advanced malignancy or other medical condition with life expectancy less than 2 years or undergoing active chemotherapy or radiation therapy.

 Advanced chronic kidney disease (CKD) defined as estimated glomerular filtration rate (GFR) < 20 mL/min/1.73 m2 based upon the Modification of Diet in Renal Disease (MDRD) study equation), or on chronic or intermittent dialysis or dialysis anticipated within the next 6 months.

 Chronic anemia with hemoglobin < 9 gm/dl for males, < 8 gm/dl for females or acute anemia requiring transfusion of 2 or more units of blood.


Adolescents' Use of Complementary and Alternative Medicine

Summary: The purpose of this study is to help improve our understanding of when and why adolescents decide to use alternative and complimentary medicines, and to understand factors that lead to better communication between youth and their clinicians.
Inclusion criteria: Adolescents ages 14-19
Exclusion criteria:


Quantitative Automated Lesion Detection of Traumatic Brain Injury

Summary: The investigators propose to develop quantitative automated lesion detection (QALD) procedures to identify brain damage following traumatic brain injury more accurately than is possible with a normal magnetic resonance imaging (MRI) scans. These procedures require about 1 hour of imaging in an MRI scanner. Subjects will also undergo about 2 hours of cognitive tests. The investigators will compare the results of the cognitive tests with those from MRI scanning to determine what brain regions are responsible for superior performance and for performance decrements.
Inclusion criteria: inclusion criteria:

 Control subjects from 18-50.

 Patients from 18-50 who have suffered TBI.

Exclusion criteria: :

 Substance abuse.

 Irremedial sensory deficits (blindness, deafness).

 Primary psychiatric disorder.

 Neurological disease unrelated to TBI.


Impact of Iron/Folic Acid vs Folic Acid Supplements During Pregnancy on Maternal and Child Health

Summary: According to a national study in 2002, the prevalence of ID, IDA, and ID+IDA among pregnant women in China was 42.6%, 9.1%, and 61.7% respectively. A similar study in Hebei province at the same time showed that the prevalence of IDA among pregnant and lactating mothers was 46.39% and 47.21% respectively. There was a significant difference between urban and rural areas. Women living in rural areas had higher chances of having IDA (p<0.01). WHO and UNICEF recommend taking iron, folic acid and multiple micronutrients during pregnancy. However, we don't know much about their influence on maternal and infant health and their clinical effectiveness. Health Department of China recommends taking 400ug folic acid before pregnancy and during early pregnancy. But for various reasons, not all expecting mothers take this advice. Besides, we don't have a national level technical standard of how to take nutrition supplements during pregnancy. Therefore, it's crucial for us to study if iron/folic acid or folic acid only can prevent perinatal complications, as well as their influences on infant and toddler health.~The purpose of this study is to test whether taking iron/folic acid and folic acid only from early pregnancy until delivery will lower the chances of pregnancy complications, and to see how supplements affect gestation results. As well, it will evaluate a) whether taking iron supplement during pregnancy can prevent IDA during pregnancy; b) whether taking iron supplement can increase mother and fetus iron storage; and c) how mother's iron level affects newborn's iron level. We hope to understand nutrition conditions during pregnancy and investigate the relations between pregnancy diet and complications during pregnancy, weight gain during pregnancy, and newborn birth weight. We will evaluate the influence of taking iron and folic acid during pregnancy on the health of infants and toddlers.
Inclusion criteria: inclusion criteria:

 uncomplicated singleton pregnancy, first enrollment visit ≤ 20 weeks gestation -

Exclusion criteria: :

 < 18 years of age

 did not live in the county

 did not anticipate delivery at participating hospital

 were not mentally competent

 had a chronic health problem or hemoglobin < 100 g/L at the initial visit

 were taking iron at the time.

['Ferrous Sulfate + folic acid', 'Folic acid']

['Iron Deficiency', 'Iron Deficiency Anemia']


Quality of Life and Dysphagia Following Palliative Stenting in Esophageal Cancer

Summary: This study consists of a prospective clinical trial which aims to evaluate the impact of stent insertion for palliation of malignant dysphagia. The main goal being to examine the number of days required following stenting in order to have significant improvement in dysphagia and the length of time that this baseline is maintained. Approximately 100 patients will be prospectively enrolled in this study.~Patients with end stage inoperable esophageal cancer deemed candidates for intraluminal esophageal palliative stent insertion will be prospectively enrolled into the study. Patients with esophageal obstruction or stricture due to other benign causes, tumors obstructing the cervical esophagus, as well as patients with airway-esophageal fistulas will be excluded from the study.~The investigators plan to evaluate the efficacy of intra-esophageal stent insertion to improve malignant dysphagia as a main factor affecting the quality of life in these patients.
Inclusion criteria: inclusion criteria:

 All patients with end stage inoperable esophageal cancer deemed candidates for intraluminal esophageal palliative stent insertions.

Exclusion criteria: :

 Inability to consent for the study.

 Patients less than 18 years old.

 Patients with other benign causes of dysphagia and esophageal obstruction or stenosis.

 Patients with malignant or benign airway - esophageal fistulas.

 Patients with cervical esophageal cancer


Antibiotics and the Prolongation of Pregnancy in Preterm Labor With an Advanced Cervical Exam

Summary: Preterm birth remains a major health concern affecting up to 12% of all live births prior to 37 weeks gestation. As preterm birth can often be associated with infection our proposal is to evaluate in a randomized fashion antibiotics for women with advanced cervical exams.
Inclusion criteria: inclusion criteria:

 All patients admitted with the diagnosis of preterm labor between 24 0/7 and 33 6/7 weeks gestation. Preterm labor will be defined by regular contractions and/or cervical change from last documented exam.

 Cervical exam 4 cm or greater

 Intact membranes

Exclusion criteria: :

 Multiple gestation (>2)

 Clinical evidence of chorioamnionitis, such as maternal fever, uterine tenderness, fetal tachycardia

 Lethal fetal anomaly

 Persistent vaginal bleeding, abruption, or placenta previa

 Rupture of membranes

 Maternal illness or fetal indication requiring delivery

 Inability to give informed consent

 Serious allergy to study medications. GI discomfort will not be considered a drug allergy

['erythromycin and metronidazole (antibiotics)', 'placebo']

['Length of Pregnancy Prolongation in Hours']


Evaluation of Two Type III GBS Polysaccharide-Tetanus Toxoid Conjugate Vaccines

Summary: The purpose of this study is to test the safety and favorable immune response to an anti-streptococcal vaccine (a vaccine that treats a common bacterial infection) in healthy non-pregnant women.~Group B Streptococcus (GBS) continues to be the single most frequent cause of life-threatening bacterial infection during the first 2 months of life. Further, GBS pregnancy-related morbidity afflicts more than 50,000 women annually in the US. Therefore, active immunization of women is an appealing strategy for the prevention of GBS disease in pregnant women and their infants during the first 3 months of infant life.
Inclusion criteria: This information currently is not available.
Exclusion criteria:

['Bacterial Infections', 'Group B Streptococcus']

Bacterial Infections
Group B Streptococcus


Chromium Piccolinate in the Prevention of Weight Gain Induced by Serotonergic Medications Initiated on Psychiatric Inpatient Units.

Summary: A majority of patients who suffer from mental illness are treated with serotonin regulating FDA approved medications. Some of these medications also block histamine transmission, increase blood prolactin levels, induce insulin resistance, hyperlipidemia, and promote sedation. All of which lead to weight gain and obesity. Many of these drugs are generally safe and effective but do carry the risk of a long term side effect in that acute and gradual weight gain of 10-30 pounds over a few months to a year of treatment. The detrimental gain of 7% of pre-drug weight is reported with many antipsychotics, mood stabilizers and some antidepressants. This weight gain may subsequently add to medical co-morbidity ( ie diabetes, hypertension, osteoarthritis, coronary artery diseasem, hyperlipidemia… ) This therapeutic manipulation of brain serotonin functioning may be associated with abnormal increases in carbohydrate cravings, consumption and weight gain. It is possible that insulin resistance occurs as a direct effect or as an indirect effect of weight gain, particularly in patients prone to weight gain or diabetes due to genetic loading. Leptin, a chemical associated with feedback signaling that reduces appetite and adipose tissue growth may also become insensitive. These multiple insults may lead to the worst weight gain in patients taking clozapine, olanzapine, and mirtazapine.~Diet and exercise and lifestyle modification are the usual initial interventions, though being depressed, anxious, bipolar, or schizophrenic often interferes with the ability to make these changes. In fact most of the studies which look at these weight loss interventions occur in patients who are institutionalized, on restricted diets and may respond to token economy systems while on longer term inpatient unit stays. This token economy approach is not easily translated to usual outpatient or short term inpatient practice settings. In these settings, if lifestyle modification approaches fail, patients may be placed on FDA approved diet medications (sibutramine, orlistat, ionamin…) which carry significant side effect risks. Some patients are even placed on the epilepsy medications such as zonisamide or topiramate at an even greater side effect risk.~In a similar weight gain prone group, there is growing literature in the diabetes population that the use of high dose chromium improves (lowers) insulin resistance by way of increasing insulin binding to cells, receptor numbers, and insulin receptor kinase activity. Lower fasting blood glucose levels in the blood generally occurs. Some reports show a reduction in blood lipid/cholesterol levels at higher chromium dosing as well. Recently, chromium piccolinate was studied in depressed patients, especially those with atypical features (usually fatigue, weight gain, carbohydrate cravings). Although there was no change in depression symptoms overall, carbohydrate cravings improved. This paper was presented at the 2005 American Psychiatric Association Annual Meeting in Atlanta. As a foil, a few papers in non-diabetics,non-depressed healthy volunteers showed little to no effectiveness in lowering blood sugar levels. Furthermore, one investigator (JLM) has published data showing acute , clinically significant weightgain in serotonergically treated psychiatric inpatients. The authors theorize that the use of chromium may reduce carbohydrate craving, appetite and thus protect against weight gain side effects.~Given this pivotal paper in the depressed population, effectiveness data in the diabetes population and some possible metabolic ties between these two populations, the author wishes to study the effect of chromium piccolinate in mentally ill subjects who are being started on serotonergic manipulating medications while in an inpatient treatment setting. These patients will be followed during their inpatient stay and then be followed after discharge for a single visit to determine acute interventional effects of chromium piccolinate. We feel chromium piccolinate is less toxic/hazardous than many of the weght loss medications that we currently use and therefore suggest a long term randomized, controlled study where subjects will receive active drug (chromium piccolinate) or placebo at the start of any serotonergic treatment while inpatient. The chromium piccolinate and the placbo will be obtained from the Nutrition 21 company, which has been approved by the FDA as a source of this product.
Inclusion criteria: inclusion criteria:

 Written informed consent is obtained.

 The subject is English-speaking and 18 through 64 years of age inclusive.

 The subject is currently receiving a serotonergic agent or is scheduled to receive a new or change in serotonergic psychotropic agents for their a psychiatric condition or can document that they have been on a stable regimen without any weight gain in last 3 months as a result.

 The subject must have capacity to obtain and give informed consent

 The subject must express concern about weight gain as a potential serotonin side effect.

 The patient is in good health as determined by a medical and psychiatric history, medical examination, and cannot have major medical illness that would jeopardize patient health during the study.

 Women must be of nonchildbearing potential [i.e., postmenopausal, be surgically sterile (hysterectomy or tubal ligation)] or must meet all of the following conditions: using a reliable, medically accepted form of contraception for at least 60 days before the baseline visit, and agree to continue such use throughout the duration of the study and for 30 days after the final dose of study drug. Reliable forms of contraception include oral, implanted, or injected contraceptives; intrauterine devices in place for at least 3 months; and adequate double-barrier methods in conjunction with spermicide (abstinence is considered an acceptable contraceptive regimen).

 Women must be given a urine pregnancy test (ßHCG), unless they are at least 2 years postmenopausal or surgically sterile, and the results of the test must be negative.

 The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.

 The patient must be a voluntary admission inpatient at SUNY Upstate Medical University's Psychiatric department in order to enroll in the study.

Exclusion criteria: :

 The patient lacks capacity to make medical decisions and ability to receive and utilize the informed consent process due to their mental illness.

 The patient is incapacitated by mental illness

 The patient is a significant risk of suicide as determined by the study team in this acute setting

 The patient has recently started a weight loss or exercise program or is taking an insulin resistance improving drug OR plans to start one upon discharge

 The patient has a co-morbid medical problem thought to induce weight gain or make it difficult to lose weight (ie hypothyroid, hypercortisol, diabetes…)

 The patient has previously ( in the last 2 months) lost or gained a significant amount of weight from any weight loss program, weight loss agent, or dietary medication.

 The patient has used an investigational drug within 1 month before the screening visit or is participating in a concurrent clinical trial.

 The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).

 The patient is highly unlikely to comply with the study protocol, be unreliable in providing ratings, or is unsuitable for any reason, as judged by the investigator.

 The patient has a clinically significant deviation from normal in the physical examination or medical history (renal or hepatic problems) which makes subject medically unstable at time of screening.

 The subject can not be currently on any medication that is clearly being used to lower weight. Examples include: Xenical, Metformin, Wellbutrin, Topomax, psycho-stimulants, and Moban.

['chromium piccolinate', 'placebo for chromium piccolinate']

chromium piccolinate
placebo for chromium piccolinate


Effects of Interpersonal Psychotherapy on Depression During and After Pregnancy

Summary: This study will evaluate the impact of interpersonal psychotherapy on the course of depression during and after pregnancy, as well as its effect on infant birth outcomes.
Inclusion criteria: inclusion criteria:

 No more than 28 weeks pregnant at the time of study entry

 History of depression or anxiety

 Current symptoms of distress

 Score of 9 or greater on the Edinburgh Postnatal Depression Scale (EPDS)

 English-speaking

Exclusion criteria: :

 Plans to move away from the area prior to giving birth

 Current use of steroids for medical conditions


Radiation Therapy + Combination Chemotherapy as 1st-Line Therapy for Patients With Inoperable Esophageal Cancer

Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.~PURPOSE: This randomized phase II/III trial is studying radiation therapy and two different combination chemotherapy regimens to compare how well they work as first-line therapy in treating patients with esophageal cancer that cannot be removed by surgery.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Histologically proven adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the esophagus

 Locally advanced disease (any T, N0 or N1, M0 or M1a)

 No metastatic disease, except for tumor involvement of the upper third of the esophagus or cervical esophageal tumor with regional nodes, or tumor involvement of the lower third of the esophagus with celiac nodes (M1a)

 Cervical primary tumor with positive supraclavicular or cervical lymph nodes (defined as N1) allowed

 No radiographic evidence of enlarged (≥ 1.5 cm) celiac lymph nodes by CT scan or echography

 No small cell or undifferentiated carcinoma of the esophagus

 No multiple carcinomas of the esophagus (i.e., > 1 esophageal tumor)

 No cardia tumor (Siewert II) or gastric tumor extension to the esophagus (Siewert III)

 Esophageal tumor extension to the cardia (Siewert I) (center of the tumor lying > 1 cm-5 cm above gastroesophageal junction) allowed

 Inoperable disease OR surgery is contraindicated

 No tracheo-esophageal fistula or invasion of the tracheo-bronchial tree

 PATIENT CHARACTERISTICS:

 ECOG performance status 0-2

 Life expectancy ≥ 3 months

 Absolute neutrophil count ≥ 1,500/mm³

 Platelet count ≥ 100,000/mm³

 Hemoglobin ≥ 10 g/dL (transfusion allowed)

 Creatinine < 15 mg/L

 Total bilirubin < 1.5 times upper limit of normal (ULN)

 ALT and AST < 2.5 times ULN

 Prothrombin time ≥ 60%

 Not pregnant or nursing

 Fertile patients must use effective contraception

 Caloric intake sufficient (i.e., > 1,000 Kcal/m²/day) (orally or with gastrostomy)

 No weight loss > 20% normal body weight within the past 3 months

 No complete dysphagia

 No exclusive requirement for parenteral nutrition

 No peripheral neuropathy > grade 1

 No sensitive peripheral neuropathy with functional impairment

 No auditory disorders

 No other prior malignancies except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix or stage I or II node-negative head and neck cancer that was curatively treated > 3 years ago

 No myocardial infarction within the past 6 months

 Patients who have had a myocardial infarction > 6 months ago are eligible provided there is no transient ischemia by thallium myocardial scintigraphy and patient is able to undergo chemotherapy , as determined by a cardiologist

 No other serious illness or medical condition (e.g., symptomatic coronary disease, left ventricular failure, or uncontrolled infection)

 No stage II-IV arterial disease, according to the DE LERICHE and FONTAINE classification

 No geographical, social, or psychological circumstances preventing regular follow-up

 PRIOR CONCURRENT THERAPY:

 No prior treatment for esophageal cancer (e.g., surgery, chemotherapy, or radiotherapy)

 No prior cervical, thoracic, or abdominal radiotherapy with field overlapping the proposed esophageal radiotherapy field

 More than 30 days since prior experimental drugs or participation in another clinical trial

 No other concurrent anticancer therapy

 No concurrent phenytoin or yellow fever vaccine

 No concurrent high-dose, long-term corticosteroids

 No concurrent calcium gluconate/magnesium sulfate infusions

 No concurrent hematopoietic growth factors

 No concurrent esophageal dilatation
Exclusion criteria:

['cisplatin', '5-FU', 'oxaliplatin', 'radiation therapy', 'Folinic Acid']

cisplatin
5-FU
oxaliplatin
radiation therapy
Folinic Acid


Hormone Replacement in Young Women With Premature Ovarian Failure

Summary: The human ovary produces male sex hormones (androgen) and female sex hormones (estrogen). Currently, androgen is not included in hormone replacement therapy for women with premature ovarian failure. Present hormone replacement therapy (HRT) was designed to treat women who experience ovarian failure at menopause (around the age of 50). However, 1% of women will experience premature failure of the ovaries before the age of 40. There have been no studies conducted to determine proper hormone replacement therapies for these younger women. Some research suggests that the usual menopausal hormone replacement therapy is not adequate to protect young women with premature ovarian failure from developing osteoporosis. Women with premature ovarian failure have abnormally low levels of androgens circulating in their blood. This may contribute to the increase risk for osteoporosis.~This study will compare two treatment plans for women with premature ovarian failure. Treatment plan one will be physiological estrogen hormone replacement. Treatment plan two will be physiological estrogen hormone replacement plus androgen. The study will attempt to determine which plan is more beneficial to women in relation to osteoporosis and heart disease.~The hormones will be contained in patches and given by placing the patches against the patient's skin. The patches were designed to deliver the same amount of hormone as would be normally produced by the ovary in young women.~The success of the treatment will be measured by periodically checking the density of patient's bone in the leg (femoral neck bone) . Researchers will take an initial (baseline) measurement of bone density before beginning treatment and then once a year, for 3 additional years, during treatment. The study will also consider bone density of the spine, bone turnover, heart disease risk factors, and psychological state.
Inclusion criteria: inclusion criteria:

 Patients with karyotypically normal spontaneous premature ovarian failure (as defined by screening protocol 91-CH-0127, i.e. women who have at least 4 months of amenorrhea, two FSH levels above 40 mIU/ml, at least one month apart, and a normal 46, XX karotype, diagnosed with premature ovarian failure prior to the age of 40) who are between the age of 18 and 42 years will be candidates.

Exclusion criteria: :

 General:

 Smokers (more than 2 cigarettes per day).

 Alcohol users (more than 2 drinks of alcohol per day).

 Body mass index (BMI, kg/m(2)) greater than or equal to 30 and less than or equal to 19.

 Previous history of hip fracture or other active hip pathology.

 Abnormalities of the hip precluding the assessment of bone mineral density.

 Major dermatologic disorders, or a history of skin sensitivity to adhesive bandages, tape or transdermal matrix patches.

 Hirsutism score greater than 8.

 Acne score greater than 1.

 Hysterectomy

 Baseline free testosterone (FT) levels above the normal range (greater than 6.3 pg/ml in our current essay) and/or SHBG levels less than 36 nmol/L.

 Medical use:

 Any prior treatment in the past 6 months known to affect bone other than estrogen (i.e., calcitonin, biphosphonates, fluoride, anabolic steroids, testosterone, or herbal therapy that contains androstenedione, and DHEA).

 Current and/or past use of: diuretics, anticoagulants (heparin, Coumadin), glucocorticoid drugs, gonadotropin-releasing hormone agonist or antagonist therapy, chemotherapy.

 Medical history of:

 Anorexia nervosa, hyperprolactinemia, insulin-dependent diabetes, Cushing's syndrome, gastrectomy, osteogenesis imperfecta, mastocytosis, rheumatoid arthritis, long-term parenteral nutrition, hemolytic anemia, hemochromatosis and thalassemia, ankylosing spondylitis, multiple myeloma, Vitamin D deficiency, Paget's disease, primary hyperparathyroidism, hyperthyroidism, hypothyroidism, any cancer or any other major illness.

 Contraindications to hormone replacement therapy:

 Thromboembolic event associated with previous estrogen use History of endometrial cancer or hyperplasia

 History of breast cancer

 Hypertriglyceridemia (fasting triglyceride levels greater than 500 mg/dL)

 LDL greater than 190mg/dl

 Patients taking statins

 Serum Alkaline phosphatase greater than or equal to 2X the upper limit of normal

 Serum GGT greather than or equal to 2X the upper limit of normal

 Abnormal values on two or more hepatic panel tests

 Undiagnosed Vaginal Bleeding

 Known sensitivity to agents

 Note: We will include patients with premature ovarian failure on antidepressant medications, since today's most common antidepressant medication (Prozac) does not have a major import on cognitive function. However, we will note whether they are on these medications.

 CONTROL SELECTION CRITERIA:

 Healthy non-pregnant regularly menstruating women (cycles between 21 and 35 days), non-smokers, non-alcohol users, under no medications, using non-hormonal contraceptive methods (i.e. barrier methods of contraception, or sterilization) and with no intention to conceive within the following 3 years.

['Healthy', 'Osteoporosis', 'Premature Ovarian Failure']

Healthy
Osteoporosis
Premature Ovarian Failure


Comparison of Ultrasound and Videofluoroscopic Imaging Techniques in Diagnosing Dysphagia in Stroke Patients

Summary: Introduction Patients with stroke may be silent aspirators or at risk for laryngeal penetration or aspiration because of abnormal oropharyngeal functioning and thus are at risk for aspiration pneumonia and its serious effects. By providing identification of the components of the abnormal swallow, and comparing swallowing across tasks, the investigators may avoid aspiration and can instruct patients on preventative or compensatory swallowing techniques.~Materials and methods~Oral examination-A neurologist and speech pathologist examine the patient's swallowing function. The patient is interviewed about difficulties with food intake, chewing and swallowing during meals.~Ultrasound examination-Ultrasound creates image of areas inside the body using sound waves. With the patient in a sitting position, a 3/4-inch transducer (device for transmitting and receiving sound waves) is placed under the chin to visualize epiglottis movements during swallowing.~Modified barium swallow-While standing or sitting, the patient swallows 1/2 teaspoon of flavored barium (a radioactive substance) six times (a total of 3 teaspoons), while the tongue and pharynx (tube leading from the mouth to the esophagus) are scanned and videotaped at the same time epiglottis movement will be trace with ultrasound. The barium is given in three consistencies-thin, medium and thick (pudding-like).~The investigators will study the oral, pharyngeal and upper esophageal phases of swallow using videofluoroscopy and correlate with ultrasound tracing of epiglottis movement in patients with stroke conditions. Most of the previous studies of swallowing have utilized diagnostic imaging technique to provide a complete swallowing assessment, but limited capabilities for screening large population of patients.~INCLUSION CRITERIA: The Stroke Center inpatients and outpatients with known or suspected dysphagia can be included for study as well as patients who are admitted specifically for this protocol. (Difficulty swallowing food or pills,changed swallowing ability,coughing or choking when eating, shortness of breath during swallowing, food backing up into the mouth or nasal passage, fever or voice changes after swallowing, pain when swallowing, unexplained loss of weight.~EXCLUSION CRITERIA: Patients who are severely demented or severely compromised will be excluded if they do not have sufficient cognitive ability to follow directions. Non-ambulatory patients will be excluded if they cannot be braced or supported within the fluoroscopy unit. Highly agitated individuals will also be excluded if they are unable to remain confined in the equipment.~Analytic Methods The Student t test will be used to analyze the difference in epiglottis movements during swallowing amongst different phases. Levene's test for equality of variances will be applied to examine the variability of epiglottis movements during swallowing between the groups. All statistical analysis will be performed with SPSS.
Inclusion criteria: inclusion criteria:

 The Stroke Center inpatients and outpatients with known or suspected dysphagia can be included for study as well as patients who are admitted specifically for this protocol. (Difficulty swallowing food or pills,changed swallowing ability,coughing or choking when eating, shortness of breath during swallowing, food backing up into the mouth or nasal passage, fever or voice changes after swallowing, pain when swallowing, unexplained loss of weight.

Exclusion criteria: :

 Patients who are severely demented or severely compromised will be excluded if they do not have sufficient cognitive ability to follow directions. Non-ambulatory patients will be excluded if they cannot be braced or supported within the fluoroscopy unit. Highly agitated individuals will also be excluded if they are unable to remain confined in the equipment.


Voriconazole vs. Amphotericin B in the Treatment of Invasive Aspergillosis

Summary: Invasive aspergillosis is a fungal disease which is increasing in incidence with the increase in immunocompromised persons in our population. Persons with prolonged neutropenia secondary to cytotoxic chemotherapies are at the highest risk for acute aspergillosis. Patients undergoing bone marrow transplantation, receiving prolonged corticosteroid or other immunosuppressive therapies, and persons with HIV infection and AIDS are also at risk. Even with antifungal therapy, aspergillosis in its acute invasive forms has a high mortality. In bone marrow transplantation patients and in those whose infection involves the brain, this mortality is greater than 90%. Amphotericin B in its conventional form, is the current standard treatment for this disease. Response to therapy with amphotericin B usually ranges between 20-60% in most studies. The higher response rates are usually seen in those patients who can tolerate this agent for at least 14 days. Because of its nephrotoxicity and other adverse effects, alternatives to conventional amphotericin B have been sought. These currently include liposomal forms of amphotericin B and itraconazole. Although these forms show a decrease in adverse effects, the efficacy of these drugs has not been shown to be equivalent to conventional amphotericin B.~Voriconazole is an investigational antifungal drug currently being brought to phase III trials in the US. This azole has been shown active against Aspergillus spp. in vitro, and in animal models and early human trials to be effective against aspergillosis. It has been shown to be well-tolerated and is available in an intravenous and oral formulation.~This study will evaluate the efficacy, safety, and toleration of voriconazole compared to conventional therapy with amphotericin B as primary treatment of acute invasive aspergillosis in immunocompromised patients. Patients will be randomized to open-labelled therapy with voriconazole or amphotericin B in a one-to-one ratio.
Inclusion criteria: Males and females of greater than 12 years of age with any of the following conditions:

 Allogeneic or autologous bone marrow/ peripheral stem cell transplant.

 Hematological malignancy (including lymphoma).

 Aplastic anemia and myelodysplastic syndromes (currently on immunosuppressive treatment).

 Solid organ transplantation.

 Solid organ malignancy (after cytotoxic chemotherapy).

 HIV infection/AIDS.

 High dose prolonged corticosteroid therapy (greater than or equal to 20 mg daily of prednisone or equivalent for greater than 3 weeks) or prolonged therapy with other immunosuppressive agents (e.g., azathioprine, methotrexate).

 WITH a diagnosis of definite or probable acute invasive aspergillosis.

 The fungal infection at baseline should represent a new episode of acute invasive aspergillosis. Any course of systemic treatment with amphotericin B (conventional or lipid formulation) or itraconazole should have been completed at least 8 weeks prior to study entry.

 Signed informed consent must be obtained prior to study participation (patient, relative or legal representative). For patients aged 12-17 years, the written informed consent of the parents or legal guardian must also be obtained.

 Women of child bearing potential must have a negative pregnancy test at entry and must agree to use barrier methods of contraception throughout the study.

 No patients with sarcoidosis, aspergilloma or allergic bronchopulmonary aspergillosis.

 No patients with chronic invasive aspergillosis with a duration of symptoms or radiological findings for more than 4 weeks prior to study entry.

 No patients that have received systemic antifungal therapy at doses greater than 0.5 mg/kg/day for conventional or lipid formulations of amphotericin B or greater than 200 mg/day of itraconazole, for more than 96 hours during the two week period prior to study entry.

 No patients with a diagnosis of CMV pneumonia.

 No pregnant or lactating females.

 No patients with a history of hypersensitivity or intolerance to azole antifungal agents including miconazole, ketoconazole, fluconazole, or itraconazole.

 No patients with a history of hypersensitivity or severe intolerance (despite supportive therapy) to conventional or a lipid formulation of amphotericin B.

 No subjects who are receiving and cannot discontinue the following drugs at least 24 hours prior to randomization: Terfenadine, cisapride and astemizole (due to the possibility of QTc prolongation); Sulphonylureas (as these compounds have a narrow therapeutic window and an increase in plasma levels may lead to hypoglycemia).

 No subjects who have received the following drugs within 14 days prior to randomization: Rifampin, carbamazepine and barbiturates as these are potent inducers of hepatic enzymes and will result in undetectable levels of voriconazole.

 No patients who are receiving or are likely to received any investigational drug (any unlicensed new chemical entity), except one of the following classes of medications: cancer chemotherapeutic agents, antiretrovirals, therapies for HIV/AIDS-related opportunistic infections.

 No patients who are receiving the following medications or treatments during the study period: G-CSF or GM-CSF (for other than of granulocytopenia) any systemic antifungal medication active against Aspergillus white blood cell transfusions.

 No patients with the following abnormalities of liver function tests: AST, ALT greater than 5x ULN (upper limit normal); alkaline phosphatase, total bilirubin greater than 5x ULN.

 No patients with renal insufficiency that would contraindicate treatment with initial randomized therapy (serum creatinine greater than 2.5 mg/dl).

 No patients with a life expectancy of less than 72 hours.

 No patients on artificial ventilation, unlikely to be extubated within 24 hours of study entry.

 No patients for whom written informed consent cannot be obtained.

 No patients that have already participated in this trial.

 No patients with any condition which, in the opinion of the investigator, could affect patient safety, preclude evaluation of response, or render it unlikely that the contemplated course of therapy can be completed.
Exclusion criteria:

['Acquired Immunodeficiency Syndrome', 'Aspergillosis', 'HIV Infections', 'Immunologic Deficiency Syndromes', 'Neutropenia']

Acquired Immunodeficiency Syndrome
Aspergillosis
HIV Infections
Immunologic Deficiency Syndromes
Neutropenia


Prospective Registry on Vascular Access in Interventions in Lazio Region

Summary: Previous randomised studies showed that radial artery catheterisation for percutaneous cardiovascular procedures has a superior safety profile than femoral access, however the confirmation of these benefits in the real world by a large, specific, observational study is still lacking.~We endeavoured to assess the access site-related outcomes of any percutaneous cardiovascular procedure by designing a prospective registry monitoring a consecutive sample of patients in a short period of time at nine Roman hospitals reflecting the contemporary state of health care.
Inclusion criteria: inclusion criteria:

 All patients undergoing any percutaneous cardiovascular procedure

Exclusion criteria: :

 Patients already enrolled in other clinical trials

['Any percutaneous cardiovascular procedure']


Effect of Acne Vulgaris on Quality of Life of Teenagers Compared to Parent Perceived Effect on Quality of Life

Summary: Acne vulgaris is a common problem in the adolescent community. Past research has shown that acne affects teenager's self-esteem and mood. However, no research has evaluated the parent perception of their teenager's acne in comparison to the severity of acne and the patient's own reported quality of life. It is hypothesized that parents of teenagers underestimate how much acne vulgaris affects their teenager's skin disease-related quality of life. Also that teenager's perception of the severity of their acne is greater versus their parent's perception. We believe that increased acne severity based on clinician assessment will correlate with worse quality of life. Teenagers between 12 and 17 years old with a diagnosis of acne by a pediatric dermatologist will be enrolled in this study. The study consists of 1 visit, questions regarding demographics, assessment of the teen's acne, the Skindex-Teen quality of life survey (modified for parents), and 2 Likert scales will be completed. In addition, the clinician will score the teen's acne using the standardized Investigator Global Assessment tool. Statistical analysis will compare teen subject answers to the Skindex-Teen with their parent's answers. Also analyzed will be the severity of acne and differences between the clinician IGA score and Skindex-Teen responses
Inclusion criteria: inclusion criteria:

 Between 12 and 17 years of age

 diagnosis of acne by a pediatric dermatologist

 ability to read and understand English

 age appropriate development

Exclusion criteria: :

 • developmental delay


Hyperbaric Oxygen, Neutrophil-oxidative Burst, and Cytokines

Summary: In this small pilot study, participants (patients and healthy volunteers) will have blood drawn before and after the study intervention (hyperbaric chamber session or normal pressure oxygen breathing. This blood will be analyzed for neutrophil oxidative burst and cytokine analysis.
Inclusion criteria: Cohort 1: Diabetic hyperbaric patients with active, chronic infection

 inclusion criteria:

 Adult patients (ages 18-65) presenting for an anticipated course of at least 4 hyperbaric oxygen sessions for chronic clinical indications (possible indications include diabetic lower extremity wounds or refractory osteomyelitis)

 Diabetes mellitus

 Current antibiotic use for active infection

Exclusion criteria: :

 Prior treatment with hyperbaric oxygen within the last 30 days

 Consistent vitamin C or vitamin E supplementation in the past year

 Active tobacco use

 Pregnancy

 Cohort 2: Hyperbaric patients without diabetes or active infection

 inclusion criteria:

 - Adult patients (ages 18-65) presenting for an anticipated course of at least 4 hyperbaric oxygen sessions for chronic clinical indications (possible indications include crush injury, acute peripheral arterial insufficiency, or radiation necrosis)

['Hyperbaric Oxygen', 'Hyperbaric Air/Oxygen', 'Normobaric oxygen']

Hyperbaric Oxygen
Hyperbaric Air/Oxygen
Normobaric oxygen


Effect of a Lateral Nerve of the Thigh Block on Postoperative Pain After Total Hip Replacement Surgery

Summary: The purpose of this study was to evaluate the analgesic efficacy of the nervus cutaneous femoral lateralis (NCFL) blockade on postoperative pain after total hip replacement surgery. The NCFL-block is a pure sensory block. We hypothesized that the NCFL-block would reduced the postoperative pain without delaying mobilization.
Inclusion criteria: inclusion criteria:

 Primary total hip replacement

Exclusion criteria: :

 general anaesthesia

 Allergy to local anesthetics of the amide type

 Revision surgery

 Bilateral surgery

 Chronic pain patient

 Women in the fertile age

['Ropivacaine', 'Placebo', 'An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively']

['Pain, Postoperative', 'Anesthesia, Conduction', 'Arthroplasty, Replacement, Hip']

Pain Postoperative Anesthesia Conduction Arthroplasty Replacement Hip


Safety Study of Two Vaccine Strategies in Patients With Systemic Lupus Erythematosus

Summary: The aim of this study is to compare the immunological efficacy of two pneumococcal vaccination strategies in patients with systemic lupus erythematosus (SLE) treated with corticosteroids associated or not with other immunosuppressive drugs : 1) a prime-boost strategy using vaccination with conjugate vaccine (Prevenar®) at week 0 and Poly Saccharidic vaccine (Pneumo23®) after 6 months (W24)2) compared to the standard vaccination with Poly Saccharidic vaccine (Pneumo23®) at W24 after placebo at W0
Inclusion criteria: inclusion criteria:

 age 18 to 65 years

 SLE as defined by the ACR classification

 Stable SLE (treatment not modified during the 2 months preceding the inclusion date W0)

 SLE treated by immunosuppressant only or systemic corticosteroids at a dose ≥ 5 mg/j or systemic corticosteroids at any dose associated with one or more immunosuppressive drugs

 SLE treated by hydroxychloroquine only

 31 months following

 females must have an effective method of contraception during the first 7 months of the study and with a negative serum or urinary pregnancy test

 females not wishing to have a child during the 7 months following W0

 physical examination

 signed written and informed consent

Exclusion criteria: :

 pregnant females or females wishing to have a child during the 7 months following W0

 subjects infected with HIV and/or HBV( Ag HBs+) and or HVC

 medical history of allergy to any vaccine component

 receipt of any pneumococcal vaccine less than 5 years

 receipt of other vaccine within one month prior to enrolment (inclusion visit W0)

 receipt of immunoglobulin within three months prior to enrolment (inclusion visit W0)

 splenectomy

 hematopoietic disorders which give contra-indications to intramuscular and hypodermic route injections,

 active malignancy , cirrhosis

 intercurrent illness within one month prior to enrolment (inclusion visit W0)

 patients under biotherapy (anti-CD20)must not been included if the interval between vaccination and the end of the biotherapy is less than one year.

 participation to another clinical study during the first 7 months of the study

 subject not covered by Health Insurance

['Prevenar® and Pneumo23®', 'Placebo, Pneumo23®']

Prevenar® and Pneumo23®
Placebo
Pneumo23®


Pivotal Trial of Dermagraft(R) to Treat Diabetic Foot Ulcers

Summary: This study randomly assigns patients with diabetic foot ulcers to receive standard therapy (surgical debridement, saline-moistened gauze and offloading) alone or standard therapy plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable Vicryl mesh. Patients are seen weekly until they heal or the 12-week treatment period is complete.
Inclusion criteria: inclusion criteria:

 Patient is 18 years of age or older.

 Patient has type I or II diabetes.

 Foot ulcer has been present for a minimum of 2 weeks under the current investigator's care.

 Foot ulcer is on the plantar surface of the forefoot or heel.

 Ulcer size is >/=1.0 cm2 at Day 0 (day of randomization).

 Ulcer extends through the dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone, or joint capsule.

 Ulcer is free of necrotic debris, exhibits no signs of clinical infection, and appears to be made up of healthy vascularized tissue.

 Patient's Ankle-Arm Index by Doppler is >/=0.7.

 Patient has adequate circulation to the foot as evidenced by a palpable pulse.

 Female patients of child bearing potential must not be pregnant and must use accepted means of birth control.

 Patient and caregiver are willing to participate in the clinical study and can comply with the follow-up regimen.

 Patient or his/her legal representative has read and signed the Institutional Review Board (IRB) approved Informed Consent form before treatment.

 Patient's study ulcer has been present (open) for at least 6 weeks at the time of the Screening visit.

Exclusion criteria: :

 There is clinical evidence of gangrene on any part of the affected foot.

 The study ulcer is over a Charcot deformity.

 The study ulcer is due to a nondiabetic etiology.

 The ulcer has tunnels or sinus tracts that cannot be completely debrided.

 The ulcer is >20 cm2 (longest dimension cannot be greater than 5 cm).

 The ulcer has increased or decreased in size by 50% or more during the screening period.

 Presence of medical condition(s) that in the Investigator's opinion makes the patient an inappropriate candidate for this study.

 Presence of a malignant disease not in remission for 5 years or more.

 Evidence of severe malnutrition, based on a serum albumin level <2.0.

 Presence of patient having known alcohol or drug abuse.

 A random blood sugar reading >/=450 mg/dL.

 Presence of urine ketones that are noted to be Small, Moderate, or Large.

 Presence of a nonstudy ulcer on the study foot within 7.0 cm of the study ulcer at Day 0.

 Use of oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, Coumadin or heparin during the study.

 A history of bleeding disorder.

 Presence of Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV).

 Participation in another study involving treatment with an investigational product within the previous 30 days.

 Elective osseous procedures to the study foot within 30 days prior to the Screening visit.

 Previous treatment with Dermagraft®.

 Presence in study ulcer of cellulitis, osteomyelitis or other clinical evidence of infection.

 Presence of condition(s) that seriously compromise the patient's ability to complete this study.


Pharmacokinetics of Eleclazine in Adults With Normal and Impaired Renal Function

Summary: This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of eleclazine and its metabolite, GS-623134, in participants with normal and impaired renal function. Participants in the healthy control group will be matched to participants with impaired renal function by age (± 5 years), gender, and body mass index (± 10%).
Inclusion criteria: inclusion criteria:

 All Individuals:

 Be a nonsmoker or consume < 20 cigarettes per day

 Have a calculated body mass index (BMI) from 18 to 36 kg/m^2, inclusive, at study screening

 Have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant by the investigator

 Screening labs within defined thresholds

 Individuals with mild, moderate, or severe renal impairment must also meet the following additional inclusion criteria to be eligible for participation in this study:

 Must have diagnosis of chronic (> 6 months), stable renal impairment with no clinically significant changes within 3 months (90 days) prior to study drug administration (Day 1)

 Individuals with severe renal impairment, creatinine clearance (CLcr) must be 15-29 mL/min, inclusive (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the screening evaluation. If an individual's score changes during the course of the study, the score at screening will be used for classification.

 Individuals with moderate renal impairment, CLcr must be 30-59 mL/min, inclusive (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the screening evaluation. If an individual's score changes during the course of the study, the score at screening will be used for classification.

 Individuals with mild renal impairment , CLcr must be 60-89, inclusive mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the screening evaluation. If an individual's score changes during the course of the study, the score at screening will be used for classification.

 Individuals with normal renal function must also meet the following additional inclusion criteria to be eligible for participation in this study:

 Must, in the opinion of the Investigator, be in good health based upon medical history, physical examination, vital signs, and screening laboratory evaluations

 Must have an CLcr of ≥ 90 mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the screening evaluation.

Exclusion criteria: :

 History of meningitis or encephalitis, epilepsy, seizures, migraines, tremors, myoclonic jerks, narcolepsy, obstructive sleep apnea, anxiety, syncope, head injuries or a family history of seizures

 Presence or history of cardiovascular disease (including history of myocardial infarction based on ECG and/or clinical history, any history of ventricular tachycardia, congestive heart failure, cardiomyopathy, or left ventricular ejection fraction < 40%), cardiac conduction abnormalities, a family history of Long QT Syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years

 Syncope, palpitations, or unexplained dizziness

 Implanted defibrillator or pacemaker

 Medical history of renal carcinoma or hepatorenal syndrome.

 Individuals receiving or anticipating use of hemodialysis, peritoneal dialysis, or any other renal replacement therapy or other medical procedure that serves as a surrogate for renal function during the study.

 Individuals with fluctuating or rapidly deteriorating renal function. Assessment of the stability of the individual's renal function will be determined by the investigator.

 Renal allograft recipients

 Experienced hypertensive crisis, required the addition of ≥1 antihypertensive drug, or required more intensive antihypertensive therapy (eg, addition of a new drug class) in the last 3 months


Examination of Microcirculation of the Caput Humeri After Proximal Humerus Fracture

Summary: This study examines the microcirculation of the caput humeri after proximal humeral fracturation using O2C light probes.~During the operation the blood circulation is measured at four points (tuberculum majus, tuberculum minus, neck and head of the humerus) directly on the bone. The O2C light probes are a none-invasive technique of measuring blood flow, velocity and oxygen concentration. The data is analysed in respect to the fracture type according to the classification of Neer.~Valuable additional information for the correct treatment and prognosis of humeral fractures is expected.
Inclusion criteria: inclusion criteria:

 traumatic fractures of the proximal humerus

 surgical treatment

 over eighteen years of age

Exclusion criteria: :

 pathological fractures

 conservative treatment

 soft tissue damage

 delay of surgery more than three days

 immunological defects

 multiple trauma


Evaluate the Impact of Drawtex in Venous Leg Ulcers

Summary: This is a clinical study to comparatively evaluate the impact of Drawtex wound dressing against wound bioburden in moderately to highly exuding venous leg ulcers.
Inclusion criteria: inclusion criteria:

 Subject > 18 years.

 Subject is attending weekly office visits at SW Wound Care Center as an out-patient.

 Subject has a moderately to highly exudative venous leg ulcer that would be indicated for treatment with Drawtex

 Subject or is informed about the trial, understands its nature of the study and provides written informed consent prior to study enrollment.

 Subject is willing and able to comply with all specified care and visit requirements

Exclusion criteria: :

 Subject has a lesion that does not meet the inclusion criteria.

 Subject refuses to participate in the study.

 Subject already participates in the this study with one wound (only one wound per subject is allowed)

 Subject has known sensitivity to the trial product or any of its compounds.

 Subject is expected to be non-compliant.

 Subject's lesion is a primary skin cancer.

 Subject's lesion is the manifestation of a metastasis.

 Subject is pregnant.

['Moderatley to Highly Exuding Venous Leg Ulcers']


Biliary Atresia, Hepatic Buffer Response and Sevoflurane

Summary: To evaluate the effects of sevoflurane on hepatic blood flow (HBF) and hepatic arterial buffer response (HABR) in infants with obstructive jaundice by Doppler ultrasound.Twenty-five infants with biliary atresia (1-3 months-of-age) scheduled for a Kasai procedure were enrolled. portal vein blood flow (PBF), hepatic arterial blood flow (HABF) and hepatic blood flow (HBF) were measured by Doppler ultrasound before induction, and after inhalation of 2 and 3% sevoflurane.
Inclusion criteria: inclusion criteria:

 persistent yellow skin or sclera, pale stool (in severe cases, clay-like), and hepatomegaly;

 increased serum bilirubin (progressively or no decline after increase), increased total bilirubin (TBil) dominated by increased direct bilirubin (DBil) (>60%);

 elevated liver enzymes;

 ultrasound confirmation of poor gallbladder filling and signs of liver fibrosis;

 with radionuclide imaging confirmation of obstructed biliary excretion

Exclusion criteria: :

 concomitant cardiovascular or abdominal organ malformations


Study of Investigational Drug in Osteoporosis (MK-0217-908)

Summary: The purpose of this study is to evaluate the efficacy and safety of an investigational drug in postmenopausal women with osteoporosis. The primary hypothesis of this study is that in postmenopausal women with osteoporosis, oral monthly ibandronate, at doses of 100 mg and 150 mg, does not achieve persistence in reduction of bone resorption throughout the monthly dosing interval, as demonstrated by a larger change in the serum carboxyterminal crosslinked telopeptide of Type I collagen (CTX-I) log-transformed fraction from baseline four weeks post dose compared to one week post dose, during the third month of treatment, in the participants taking ibandronate than in the participants taking placebo.
Inclusion criteria: inclusion criteria: -postmenopausal for at least 3 years, with osteoporosis at any of the following sites: [BMD > 2.0 standard deviations below young normal mean bone mass for the hip trochanter, PA lumbar spine (L1 to L4), total hip, or femoral neck based on the normative database provided by each individual manufacturer].

 willing to take study-supplied calcium and vitamin D supplement (or equivalent) and to discontinue any non-study calcium supplements for run-in period and the duration of the study.
Exclusion criteria: : -pregnant or lactating, or of childbearing potential.

 participated in another therapeutic trial with an investigational compound within 30 days of randomization.

 history of hypersensitivity to any component of ibandronate tablets or has hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

 an abnormality of the esophagus which delays esophageal emptying such as stricture or achalasia.

 unable to stand or sit upright for at least 60 minutes once a month.

 current use of illicit drugs, or history of drug or alcohol abuse within the past five years.

 has any of the following: hypocalcemia; any severe malabsorption syndrome; moderate or severe hypertension which is uncontrolled; new onset angina or myocardial infarction within six months of entry into the study; evidence for impaired renal function; organ transplantation; or other significant end organ diseases (genitourinary, cardiovascular, endocrine, hepatic, psychiatric, renal, hematologic, or pulmonary).

 history of or evidence of metabolic bone disease (other than postmenopausal bone loss).

 clinical fracture in the past year.

 is receiving or has received treatment prior to randomization which might influence bone turnover.

 is receiving or expected to receive during the course of the study any medication (other than study medication) which might alter bone or calcium metabolism, including Vitamin A in excess of 10,000 IU per day or Vitamin D in excess of 5000 IU per day, calcitonin, phenytoin, heparin, or lithium.


Biomarker Feedback for Smoking Cessation

Summary: The purpose of this study is to examine the impact of providing light smokers with feedback about their health, including exposure to tobacco-related chemicals.
Inclusion criteria: inclusion criteria:

 Male or female cigarette smokers, 18-75 years

 Smoked an average of less than 10 cigarettes per day during past month

 A personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion criteria: :

 Only one subject per household may participate

 Pregnancy


BG9588 (Anti-CD40L Antibody) to Treat Lupus Nephritis

Summary: The purpose of this study is to investigate whether the experimental drug BG9588 can be used to treat lupus nephritis more effectively and with less toxicity than standard treatments, including cyclophosphamide (Cytoxan), azothioprine (Imuran) and prednisone.~The body's immune system naturally produces antibodies to fight foreign substances like bacteria and viruses. In autoimmune diseases like lupus, however, the body makes antibodies that attack its own tissues, causing inflammation and organ damage. Lupus antibodies attack and damage kidney cells. BG9588 can interfere with the production of these antibodies, and therefore, may lessen kidney damage in people with lupus nephritis.~This study will look at: how BG9588 enters and leaves the blood and body tissue over time; adverse effects of the drug; and whether treatment with BG9588 can result in less kidney damage than other therapies.~Study patients will be receive a 30-minute infusion of BG9588 into a vein every two weeks for three doses and then once every 28 days for four doses. Patients' steroid dosage may be tapered; individual adjustments will be made as required.~Patients screened for the study will undergo a physical examination, medical history, various blood and urine tests, as well as complete a quality of life questionnaire. Results of a previous kidney biopsy and chest X ray are also required. Many of these tests will be repeated throughout the study.~In a previous animal study, BG9588 treatment of mice with lupus nephritis improved their disease and survival.
Inclusion criteria: Must give written informed consent prior to any testing under this protocol.

 Must be 18 years or older, inclusive, at the time of informed consent.

 Must have a renal biopsy showing active WHO Class III, IV, or mixed membranous and proliferative SLE GN, within the 5 years prior to the first dose of study drug.

 Must have proteinuria of greater than or equal to 1.0 g/day at both the Day-27 and day-13 evaluations.

 Must fulfill any one the following four criteria, at each of the two screening visits (i.e., Day-27 and Day-13):

 Anti-dsDNA antibody greater than 2x the upper limit of normal (ULN).

 C3 complement less than 80 mg/dL.

 Hematuria greater than 5 rbc/hpf.

 Urinary granular or red blood cell casts.

 Must not have any medical disorder, which in the opinion of the investigator, should exclude the subject from this study.

 Must not have prior arterial or venous thrombosis, or history of recurrent abortion (3 or more), in the presence of anti-cardiolipin antibodies.

 Must not have a chest x-ray with evidence of active infection or neoplasm within the 6 months prior to the first dose of study drug.

 Must not have rapidly progressive glomerulonephritis, defined as a doubling of serum creatinine, within the 3 months prior to the first dose of study drug.

 Must not have fibrinoid necrosis and/or cellular crescents affecting more than 25 percent of glomeruli in any renal biopsy performed within the 3 months prior to the first dose of study drug.

 Must not have clinically significant findings for any of the following within the 4 weeks prior to the first dose of study drug: active psychiatric disease, serum creatinine greater than 2.0 mg/dL, prothrombin time (PT) greater than 1.3x control (in the absence of coumadin therapy; abnormal PT values due to anti-coagulation therapy are allowed if within the therapeutic range), AST or ALT levels greater than 3x normal, other major organ dysfunction, or serious local or systemic infection (e.g., pneumonia, septicemia).

 Must not be positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HVC Ab), or HIV antibody at the Day-27 evaluation.

 Must not have a mean CD4 count less than or equal to 300 microliters (mean of Day-27 and Day-13 results).

 Must not have treatment with an antibody or other investigational drug within the 3 months prior to the first dose of the study drug.

 Must not have any vaccination within the 4 weeks prior to the first dose of the study drug.

 Must not have treatment with IV or oral cyclophosphamide within the 4 weeks prior to the first dose of the study drug.

 Must not have treatment with any of the following medications within the 4 weeks prior to the first dose of study drug: IV methylprednisolone, cyclosporine or related compound, or oral prednisone (equivalent oral glucocorticoid) at a dose greater than 0.5 mg/kg/day.

 Must not have initiation of treatment with ACE inhibitors within the 4 weeks prior to the first dose of study drug.

 Must not have initiation of treatment with azathioprine, methotrexate or mycophenolate mofetil within the 4 weeks prior to the first dose of study drug.

 Must not have treatment with any new oral or new IV antibiotic within the 2 weeks prior to the first dose of study drug. Subjects on prophylactic antibiotics are permitted to continue these during the study.

 Female subjects, unless post-menopausal or surgically sterile, must use an adequate method of contraception.

 Women must not be currently breast-feeding.

 Must not have a positive pregnancy test in any evaluation prior to the first dose of study drug.

 Must not be currently enrolled in any other study in which the subject is receiving any type of drug or non-drug therapy.

 Must not have been previously dosed with BG9588.
Exclusion criteria:

['Glomerulonephritis, Membranoproliferative', 'Lupus Nephritis']

Glomerulonephritis
Membranoproliferative
Lupus Nephritis


Effect of Bisphosphonate on Bone Loss in Postmenopausal Women With Breast Cancer Initiating Aromatase Inhibitor Therapy

Summary: Elderly, postmenopausal women with breast cancer on aromatase inhibitors are at increased risk of developing bone loss and osteoporosis. We postulate that in elderly, osteopenic postmenopausal women who are on aromatase inhibitor therapy, bisphosphonate therapy will (1) prevent bone loss at clinically relevant sites, such as the spine and hip and (2) decrease bone turnover.
Inclusion criteria: inclusion criteria:

 elderly postmenopausal women (ages 55 and older)

 osteopenic (DXA T-score -1.0 to -2.5 SD). However, after full counseling about the risks, benefits, and options regarding therapy for osteoporosis and discussion with her PCP, an osteoporotic woman may enroll in the study.

 with breast cancer on aromatase inhibitor therapy

 with no evidence of distant metastatic disease or osteoporosis (by BMD or clinical history)

 type of surgical procedure or addition of radiation therapy prior to this aromatase inhibitor therapy will not exclude patients

 Participants must provide voluntary, written informed consent to participate in the study, which includes understanding of the procedures, medications, and risks and benefits

Exclusion criteria: :

 Women with stage 4 breast cancer (presence of distant metastases)

 Women with normal bone density by DXA (T-score > -1.0 SD)bone density by DXA, except in the instance of a fragility fracture.

 Women with history of any illness known to affect bone and mineral metabolism, such as renal failure (estimated GFR <30), hepatic failure, malignancy (excluding breast cancer, treated superficial basal and squamous cell carcinoma and malignancies where the diagnosis itself or its treatment would not adversely affect bone metabolism), untreated primary hyperparathyroidism, and malabsorption.

 Women being treated with oral glucocorticoid therapy >3 months for suppression therapy, and certain anti-seizure medications which may adversely affect bone metabolism (phenobarbital, phenytoin, carbamazepine).

 Those with untreated active peptic ulcer disease

 Those with osteoporosis by BMD (T-score -2.5 SD at the spine or total hip) or a history of fragility fracture as an adult. However, as discussed above, osteoporotic women may elect to enroll in the study.

 Women treated with oral bisphosphonates or calcitonin for 3 months within the last year (3 month washout period)

 Men and children will be excluded because they do not get postmenopausal osteoporosis following treatment with an aromatase inhibitor

 Women with very poor dental hygiene (as assessed by the baseline dental exam) in need of dental extraction during the study

 Use of fluoride for more than 1 month ever (except for dental treatment)

 Less than 2 evaluable vertebrae

 Distant metastatic disease

['Breast Cancer', 'Bone Loss', 'Osteoporosis']


Trial of Combination Antifungal Therapy (Vori+Mica vs. Vori+Placebo) in Invasive Aspergillosis

Summary: The purpose of this study is to evaluate the therapeutic effectiveness of combination antifungal therapy (CAT) of voriconazole plus micafungin versus voriconazole plus placebo equivalent as primary therapy for invasive aspergillosis (IA) in patients with hematological cancer.
Inclusion criteria: inclusion criteria:

 The patient or legally authorized representative has signed an informed consent/assent.

 Assent will be obtained as required by the UAMS IRB.

 The patient has a diagnosis of proven or probable invasive aspergillosis and with positive Aspergillus GM index (≥0.5 ng/ml) provide the patient is not receiving antibiotics, such as piperacillin-tazobactam, that are known to cause false positive GMI

 The patient is 18 years of age or older.

Exclusion criteria: :

 The patient is being treated with an unlicensed investigational drug for aspergillosis.

 The patient has been administered an antifungal agent (voriconazole, itraconazole, posaconazole, caspofungin, micafungin, anidulafungin, amphotericin B, or lipid formulation of amphotericin B) for > 7 days immediately prior to randomization for treatment of the Probable, or Proven invasive aspergillosis for which the patient is being enrolled.

 Patient has invasive aspergillosis but with negative Aspergillus GM index.

 The patient is pregnant or lactating. If the patient is female and of childbearing potential, the patient must have a negative pregnancy test and avoid becoming pregnant while receiving study drug. A pregnancy test should be performed within 14 days prior to the first dose of study drug.

 The patient has alkaline phosphatase, ALT, AST or total bilirubin greater than five times the upper limit of normal.

 The patient has hepatic cirrhosis.

 Patients with creatinine > 3 will be enrolled only if able to receive oral voriconazole (specify oral loading dose is 6 mg/kg PO Q 12 hours for 24 hours) then oral maintenance 200 mg PO q 12 hours).

 The patient is on artificial ventilation, and unlikely to be extubated within 24 hours of study entry.

 The patient has a history of allergy, hypersensitivity, or any serious reaction to the azole or echinocandin class of antifungal agents.

 The patient has previously enrolled into this study.

 The patient has a concomitant medical condition, which in the opinion of the Investigator may create an unacceptable additional risk.

 The patient has an active microbiologically-documented deep infection due to a non-Aspergillus mold.

 The patient has a life expectancy of less than seven days.


Shared Decision Making in Graves Disease - Graves Disease (GD) Choice

Summary: The investigators' decision aid for patients with GD, GD Choice, will be the result of a user-centered participatory action research involving) synthesis of the best available evidence from the literature and real-world registry experience, ii) input and involvement of patients, clinicians and other stakeholders, iii) direct observation of encounters and iv) extensive field-testing. The goal is to create a decision aid that will be rigorously evidence-based, clear and complete, able to be used by clinicians with minimal training time, while satisfying extant standards for rigorous high-quality shared decision making tools.
Inclusion criteria: inclusion criteria:

 Adults ≥ 18 years

 Diagnosis of Graves Disease

 Appointment with endocrinologist to discuss treatment options for Graves Disease

Exclusion criteria: :

 Major barriers to participate in shared decision making or to providing informed consent (i.e. dementia, severe hearing or visual impairment)

["Graves' Disease", 'Thyroid Disease', 'Hyperthyroidism']

Graves' Disease
Thyroid Disease
Hyperthyroidism


Rajavithi Health Promotion Project (Population Base Cohort)

Summary: Metabolic Syndrome (hypertension, diabetes mellitus, obesity, cerebrovascular-cardiovascular disease) In Community Survey was performed in central Bangkok.~Prospective Cohort and intensive educated intervention (health promotion program in specific high risk groups) were performed. The aim of the study is to identify high risk patients who can develop serious complications from metabolic syndrome. An analysis of health outcomes in multiple dimensions will be performed.
Inclusion criteria: inclusion criteria:

 Age 16 years or more

 Informed consent

 Living in selected community (Health Promotion area of Rajavithi Hospital)
Exclusion criteria:

['Intensive Education for Metabolic Syndrome Patients']

['Diabetes Mellitus', 'Hypertension', 'Dyslipidemia', 'Obesity', 'Cardiovascular Disease', 'Coronary Artery Disease']

Diabetes Mellitus
Hypertension
Dyslipidemia
Obesity
Cardiovascular Disease
Coronary Artery Disease


Third Party Viral Specific T-cells (VSTs)

Summary: The purpose of this study is to demonstrate that viral specific T-cells (a type of white blood cell) can be generated from an unrelated donor and given safely to patients with viral infections.
Inclusion criteria: inclusion criteria:

 Immunocompromised patient with evidence of viral infection or reactivation

 Age >1 day

 Recipients who have had a stem cell transplant must be at least 21 days after stem cell infusion

 Clinical status must allow tapering of steroids to < 0.5mg/kg prednisone or other steroid equivalent

 Must be able to receive CTL infusion in Cincinnati

 Informed consent obtained by PI or sub-investigator either in person or by phone

Exclusion criteria: :

 Active acute GVHD grades II-IV

 Uncontrolled bacterial or fungal infection

 Uncontrolled relapse of malignancy

 Infusion of ATG or alemtuzumab within 2 weeks of VST infusion

['Viral Infection', 'Viral Reactivation', 'Infection in an Immunocompromised Host']

Viral Infection
Viral Reactivation
Infection in an Immunocompromised Host


Multi-institutional Trial of Non-operative Management of Appendicitis

Summary: A successful non-operative management strategy for early appendicitis will decrease the number of children requiring surgery and may improve the quality of care related to the treatment of appendicitis. To account for the child-family perspective and treatment preferences, the investigators will perform a study in which patients and their families choose between antibiotics alone (Non-operative group) or appendectomy (Surgery group) at ten U.S. hospitals. This study will determine the effectiveness of non-operative management of early appendicitis with antibiotics alone in children and compare differences in morbidity, disability, quality of life, satisfaction, and cost between families choosing surgery or non-operative management.
Inclusion criteria: inclusion criteria:

 English and non-English speaking patients

 Age : 8-17 years

 US or CT confirmed early appendicitis with US showing hyperemia, ≤ 1.1 cm in diameter, compressible or non-compressible, no abscess, no fecalith, no phlegmon or CT showing hyperemia, fat stranding, ≤ 1.1 cm in diameter, no abscess, no fecalith, no phlegmon

 White Blood Cell count > 5,000/µL and ≤ 18,000/µL

 Abdominal pain ≤ 48hours prior to receiving antibiotics

Exclusion criteria: :

 History of chronic intermittent abdominal pain

 Pain > 48 hours prior to first antibiotic dose

 Diffuse peritonitis

 Positive urine pregnancy test

 White Blood Cell ≤ 5,000/µL or ≥ 18,000/µL

 Presence of a fecalith on imaging

 Evidence on imaging studies concerning for evolving perforated appendicitis including abscess or phlegmon

 Communication difficulties (e.g. severe developmental delay)