Decitabine in Treating Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Iodine I 131

Summary: This phase II trial is studying how well decitabine works in treating patients with metastatic papillary thyroid cancer or follicular thyroid cancer that has stopped responding to radioactive iodine. Iodine I 131 (radioactive iodine) kills thyroid cancer cells. Metastatic thyroid cancer cells can lose the ability to be treated with radioactive iodine. Decitabine may help thyroid cancer cells regain the ability to respond to treatment with radioactive iodine.
Inclusion criteria: inclusion criteria:

 Histologically confirmed papillary thyroid or follicular thyroid carcinoma:

 Differentiated disease;

 Metastatic disease documented by ultrasound, computed tomography (CT) scan (without iodinated contrast), or MRI - All metastatic disease foci =< 10 mm in all dimensions

 Must have been treated with total or near-total thyroidectomy AND at least 1 course of iodine I 131 (131I)(>=29.9 mCi) OR demonstrated negative uptake on a postoperative low-dose131I scan

 Must have undergone whole body 131I scan 1-3 days after administration of =< 5.5 mCi of 131I demonstrating no visible iodine uptake within the lesions unless demonstrated negative uptake on a postoperative low-dose131I scan within the past 12 weeks:

 Must have 24-hour urine iodine excretion =< 500 mcg within 1 week of 131I scan

 Must be receiving thyroid hormone therapy AND have thyroid-stimulating hormone level =< 0.5 mU/L

 No known brain metastases

 Performance status:

 Eastern Cooperative Oncology Group (ECOG) 0-2 OR Karnofsky 60-100%

 Hematopoietic:

 Absolute neutrophil count >= 1,500/mm3;

 Platelet count >= 100,000/mm3;

 White Blood Count (WBC) >= 3,000/mm3

 Hepatic:

 aspartate aminotransferase-alanine aminotransferase (AST and ALT) =< 2.5 times upper limit of normal;

 Bilirubin normal

 Renal:

 Creatinine not elevated OR

 Creatinine clearance >= 60 mL/min

 Cardiovascular:

 No symptomatic congestive heart failure;

 No unstable angina pectoris;

 No cardiac arrhythmia

 Not pregnant or nursing

 Negative pregnancy test

 Fertile patients must use effective contraception

 No prior allergic reaction attributed to compounds of similar chemical or biological composition to decitabine

 No concurrent uncontrolled illness

 No active or ongoing infection

 No psychiatric illness or social situation that would preclude study compliance

 No prior cytotoxic chemotherapy for thyroid cancer

 At least 6 months since prior external beam radiotherapy administered for locoregional disease in the thyroid bed or to the cervical or upper mediastinal lymph node regions (no more than 6,000 cGy)

 More than 6 months since other prior radiotherapy and recovered

 More than 6 months since prior therapeutic 131I > 10 mCi

 More than 18 months since prior cumulative 131I activity of at least 500 mCi

 More than 12 months since prior amiodarone (Unless 24-hour urinary iodine excretion is =< 500 mcg)

 No concurrent combination antiretroviral therapy for HIV-positive patients

 No other concurrent anticancer therapy

 No other concurrent investigational agents

 More than 6 months since prior intrathecal iodinated contrast (Unless 24-hour urinary iodine excretion is =< 500 mcg)

 More than 3 months since prior IV or oral iodinated contrast for radiographic studies (Unless 24-hour urinary iodine excretion is =< 500 mcg)
Exclusion criteria:

['Decitabine', 'Iodine I 131', 'Recombinant thyrotropin alfa', 'Fludeoxyglucose F 18', 'Positron emission tomography']

Decitabine
Iodine I 131
Recombinant thyrotropin alfa
Fludeoxyglucose F 18
Positron emission tomography

['Recurrent Thyroid Cancer', 'Stage IVA Follicular Thyroid Cancer', 'Stage IVA Papillary Thyroid Cancer', 'Stage IVB Follicular Thyroid Cancer', 'Stage IVB Papillary Thyroid Cancer', 'Stage IVC Follicular Thyroid Cancer', 'Stage IVC Papillary Thyroid Cancer']

Recurrent Thyroid Cancer
Stage IVA Follicular Thyroid Cancer
Stage IVA Papillary Thyroid Cancer
Stage IVB Follicular Thyroid Cancer
Stage IVB Papillary Thyroid Cancer
Stage IVC Follicular Thyroid Cancer
Stage IVC Papillary Thyroid Cancer


Case Report of Endometrioma in Layers of Broad Ligament.

Summary: Objective:To present an extremely rare site of occurrence of endometriotic cyst in the layers of Broad Ligament.~Patient:A 32 yrs.old woman,married 4 yrs.,presented to OB-GY Dept.with acute,gnawing pain in lower abdomen and history of sub-fertility.Diagnostic Laparoscopy and pelvic ultrasound were performed in emergency.Oblong cyst structure,41x21x23mm in the left adnexa,away from ovary and uterus was identified and excised by Four Port laparoscopic interventional surgery.
Inclusion criteria: inclusion criteria:Sub-fertile women with confirmed diagnosis of pelvic endometriosis.

 -

Exclusion criteria: :women with Pelvic inflammatory disorders and other forms of benign cysts.


Phase 4 Study To Assess The Safety Of Vivotif At Different Release Titers Among Travelers

Summary: This is a multicenter (at travel clinics), phase 4 observational prospective cohort study in healthy adult male and female travelers for whom typhoid vaccination with Vivotif is recommended, as per standard practice.
Inclusion criteria: inclusion criteria:

 Subjects are male or female aged ≥ 18 years at time of dosing

 Subjects are travelers attending travelers' vaccination clinics

 Subjects are eligible for typhoid vaccination, according to standard practice

 Subjects are expected to be able to provide follow-up information

 Subjects have an expected travel departure date more than 21 days after enrollment (to enhance follow-up by ensuring subjects remain in the US during the AE collection period)

 Subjects must sign a written informed consent

Exclusion criteria: :

 Subjects with a known hypersensitivity to any component of the vaccine or the enteric coated capsule

 Subjects deficient in their ability to mount a humoral or cell-mediated immune response due to either a congenital or acquired immunodeficient state including treatment with immune-suppressive or antimitotic drugs

 Subjects with an acute febrile illness

 Subjects with acute gastrointestinal (GI) illness

 Subjects who are receiving medications with antibacterial activity (including proguanil) at the time of enrollment

 Subjects with other contraindications as determined by the site investigator


A Clinico-Bacteriological Study and Effect of Stress Ulcer Prophylaxis on Occurrence of Ventilator Associated Pneumonia

Summary: Objective of this study was to determine incidence, risk factors, etiological micro-organisms and their antimicrobial susceptibility pattern and outcome of VAP; and to study effect of ranitidine vs. sucralfate, used for stress ulcer prophylaxis, on gastric colonization and on occurrence of VAP.~Methods: Design: Prospective randomized study. Setting: ICUs of Medicine Department and Anesthesiology Department, Maulana Azad Medical College and Lok Nayak Hospital, University of Delhi, New Delhi. Patients: 50 patients of age more than 12 years, who had been on ventilator for more than 48 hrs. Intervention: Endotracheal Aspirate and blood sample of all patients were cultured to determine micro-organisms causing VAP and their antimicrobial susceptibility pattern. Patients were divided into 2 groups on random basis. The first group was given ranitidine for stress ulcer prophylaxis while the second was given sucralfate. Thereafter, difference in gastric colonization (on basis of quantitative culture of nasogastric aspirate) and on occurrence of VAP in both the groups was compared.~Study Hypothesis: Study was designed to create data about Ventilator associated pneumonia in developing countries like India. This data is crucial for providing information for deciding future guidelines for treatment of and prevention of Ventilator associated pneumonia. Further to test the hypothesis that H2 blockers, by virtue of raising gastric Ph, increase gastric colonization by pathogenic organism and increase incidence of Ventilator associated pneumonia; patients were divided into two groups on random basis, as described above.
Inclusion criteria: inclusion criteria:

 Age greater than 12 years

 Those on mechanical ventilation for more than 48 hours.

Exclusion criteria: :

 Pre-existing pneumonia at the beginning of ventilation or

 Developing pneumonia within 48 hours of ventilation.

 Patients on oral antibiotics

['Ventilator Associated Pneumonia', 'Etiological Organisms', 'Antimicrobial Drug Susceptibility Pattern', 'Stress Ulcer Prophylaxis']


Outcomes Associated With Early or Delayed Maintenance Treatment Post-Chronic Obstructive Pulmonary Disease Exacerbation

Summary: The timing of initiating short-term treatment for COPD exacerbations with oral corticosteroids and/or antibiotic therapy has been shown to influence the recovery time of exacerbations with early initiation of exacerbation therapy having a faster symptom recovery compared to delayed initiation. While oral corticosteroids and/or antibiotic therapy are crucial for immediate exacerbation therapy, maintenance therapy with controller medications for COPD has been recommended to reduce the risk of future exacerbations. The initiation of maintenance therapy after a COPD exacerbation has been shown to be beneficial in the reduction of risk of future exacerbations. However, there is a lack of information on whether the timing of this initiation influences the risk of future exacerbations. The following study evaluates the impact of early versus delayed initiation of controller medication therapy for maintenance treatment following a COPD-related exacerbation on outcomes of future exacerbations and costs in patients with COPD.
Inclusion criteria: inclusion criteria:

 at least 40 years of age,

 continuously enrolled for medical and pharmacy benefits during their pre- and post-period

 diagnosis of COPD (ICD 491.xx, 492.xx, 496.xx)

Exclusion criteria: :

 Patients were excluded if they had MTx in the pre-index period (to ensure inclusion of MTx-naïve patients) or if they received their first MTx during 181 to 365 days of the post-period (as dispensing of MTx unlikely to be related to the index exacerbation).

 Additionally, patients were excluded if they had any of the following comorbid conditions anytime during the study period: respiratory cancer, cystic fibrosis, fibrosis due to, bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary tuberculosis, or sarcoidosis, and

 also if they had other doses (unapproved in the US) of fluticasone propionate-salmeterol xinafoate combination (100/50 mcg or 500/50 mcg) or budesonide dipropionate-formoterol fumarate fixed dose combination (any dose).

['Early maintenance treatment', 'Delayed Maintenance treatment']

Early maintenance treatment
Delayed Maintenance treatment

['Pulmonary Disease, Chronic Obstructive']


Microbiology and Clinical Outcome of Pneumonia

Summary: BACKGROUND~Pneumonia occurring outside of the hospital setting is regarded as community acquired pneumonia. However, pneumonia occurring in non-hospital long-term care facilities constituted a distinct type of pneumonia from CAP. Kollef et al has justified health care associated pneumonia (HCAP) as a new category of pneumonia [1]. The HCAP patients are associated with severe disease, higher mortality rate, and greater length of stay and increased cost [1]. HCAP are often at risk for multi-drug resistant bacterial pathogens such as Pseudomonas aeruginosa, extended-spectrum beta-lactamase Klebsiella pneumoniae, Acinetobacter baumannii, and methicillin-resistant S. aureus (MRSA) [2].~Health care facilities have not been defined in Taiwan. Respiratory care ward (RCW) is a special unit to take care long-term ventilatory dependent patients in Taiwan. Some of the patients get pneumonia and are referred back to medical centers. Besides, community-acquired P. aeruginosa, Acinetobacter baumannii or MRSA have been reported [3-8]. Therefore, the core-organisms of HCAP in Taiwan might be multi-drug resistant and the causes of inadequate initial antibiotics treatment. The common pathogens were also unknown.~Till now, there are no data about the pathogens of HCAP in Taiwan. We define the health-care facilities and initiate a retrospective study to characterize the microbiology and clinical outcome of Community acquired pneumonia and Health-Care-Associated pneumonia in Taiwan. Further analysis will perform to confirm the differences between CAP an HCAP in Taiwan.~Objectives:~I. To characterize CAP and HCAP i. Microbiological epidemiology ii. Disease severity: PSI iii. Outcome : length of stay, mortality , antimicrobial susceptibility and treatment outcomes II. To characterize HCAP from RCW i. Microbiological epidemiology ii. Disease severity: PSI iii. Outcome : length of stay, mortality~Study design:~This is a retrospective multi-center cohort study to characterize microbiology, and clinical outcomes in Taiwan.~Data sources: CAP or HCAP registered in 4 medical centers from Jan 1 2007 to Dec. 31 2007. (2 in north Taiwan, 1 in central Taiwan, 1 in south Taiwan) Expected case number: 800 HCAP and 1800 CAP
Inclusion criteria: inclusion criteria:

 CAP criteria:

 Those pneumonia patients have not been admitted within 14 days before diagnosing pneumonia.

 Those pneumonia patients are not met the criteria of HCAP criteria as stated below.

 HCAP criteria:

 Regular hemodialysis, peritoneal dialysis or infusion therapy (ex TPN, repeated blood transfusion etc ) at a hospital or hemodialysis clinic.

 Receive radiation therapy or chemotherapy at out-patient clinics within 90 days

 to be admitted to an acute care hospital for two or more days within 90 days before the onset of pneumonia

 Resided in a nursing home or long-term care

Exclusion criteria: :

 The patients with HAP: pneumonia developed two days after admission or within 14 days after discharge (except RCW)

 VAP: HAP and with mechanical ventilation for at least 48h (except RCW patients)

 HIV positive with a CD4+ < 200


Caspofungin Study for Fungal Infections in Adults in Critical Care Settings

Summary: Adults admitted to intensive care units are at risk for a variety of complications. One of the most frequent complications is the development of new infections. Infections due to a fungus called Candida are of particular concern. This study will test the possibility that caspofungin, a new therapy for fungal infections, may reduce the rate of Candida infections in subjects at risk.
Inclusion criteria: inclusion criteria:

 Non-pregnant subjects >/= 18 years of age; admission to the ICU during the preceding 3 days (minimum of 2 days in ICU) and expected to stay in the ICU a minimum of 2 additional days; subjects must have at least 1 of the following: received at least one other dose of any systemic antibiotic on any one of the ICU days before study entry and continue to receive antibiotics at the time of enrollment, and/or presence of a central venous catheter at the time of enrollment and for one additional day during the current ICU stay, and at least 2 of the following: use of total parenteral nutrition on any of Days 1-4 of ICU stay; any type of dialysis on any of Days 1-4 of ICU stay; any in-patient surgery done under general anesthesia or epidural block in the 7 days prior to or on ICU admission*; pancreatitis (documented by computed tomography (CT) scan or lipase >1,000 u/L) in the 7 days prior to or on ICU admission; more than 1 dose of systemic steroids (prednisone equivalent dose >/=20 mg per dose) in the 7 days prior to or on ICU admission; and/or use of more than 1 dose of other systemic immunosuppressive agents (such as azathioprine, tacrolimus, sirolimus, mycophenolate, monoclonal antibodies, and tumor necrosis factor [TNF] immunomodulators) in the 7 days prior to or on ICU admission.

 Excludes placement of vascular catheters.

Exclusion criteria: :

 Subjects with an allergy or intolerance to caspofungin or other echinocandin analog; absolute neutrophil count <500/mm3 at entry or likely to develop such a count during therapy; diagnosis of HIV, aplastic anemia, or chronic granulomatous disease; moderate or severe hepatic insufficiency as defined by a Child Pugh score of 7 or greater or cirrhosis due to any cause; pregnancy or breastfeeding; subjects unlikely to survive more than 2 days; subjects who have received systemic antifungal therapy within 7 days prior to study entry; subjects with documented active, proven, or probable invasive fungal infection within 7 days prior to study entry; subjects previously enrolled into this trial; subjects currently receiving another investigational agent or who have received an investigational agent within the 7 days prior to study entry; subjects in the ICU 5 or more days prior to enrollment into this study .


U-CHAMP: Urban Cardiovascular Health Assessment and Management Program

Summary: High blood pressure, elevated blood glucose and high cholesterol are related to the increased risk of stroke and heart disease. Many studies have shown that this risk can be significantly reduced by lowering blood pressure, blood glucose and cholesterol levels.~Through a collaborative effort between Calgary Safeway pharmacists and Calgary Health Region family physician PCN's, U-CHAMP will deliver a program to assist in the identification and management of people with elevated blood pressure, blood glucose and cholesterol and through this effort, reduce the risk of heart disease and stroke in the urban Calgary population aged 18-85 years.
Inclusion criteria: inclusion criteria:

 Adults 18-85 years

 Signed consent

Exclusion criteria: :

 None

['participant referral to primary care network physician']

['Cardiovascular Diseases', 'Hypertension', 'Hyperlipidemia', 'Hyperglycemia']

Cardiovascular Diseases
Hypertension
Hyperlipidemia
Hyperglycemia


Biatain Ag vs Biatain in the Treament of Leg Ulcers

Summary: the objective of this investigation is to demonstrate the effect of the foam dressing Biatain Ag, compared to Biatain foam dressing( a product which is similar but does not contain a silver complex, in the healing of leg ulcers that had failed to heal despite appropriate therapy
Inclusion criteria: inclusion criteria:

 • Patients over 18 who have given written informed consent

 Patients with a venous or predominantly venous leg ulcer (ankle-brachial index > 0.8) that is between 2 cm and 13 cm in all directions

 Patients with a moderately or severely exudating leg ulcer in the phase of debridement or formation of granulation tissue

 Patients with a leg ulcer that is not healing properly despite suitable and well-conducted local treatment in the four weeks prior to inclusion

 Patients with a leg ulcer that has been treated with appropriate compression in the four weeks prior to inclusion

 Patients who are available for monitoring for at least 10 weeks

Exclusion criteria: :

 • Patients whose leg ulcers are clinically infected (including erysipelas and cellulitis of the skin around the ulcer) requiring systemic antibiotic treatment

 Patients who have undergone surgery on the saphenous trunk within the two months prior to inclusion

 Patients whose leg ulcer being considered for the study has been treated with local antibiotics or antiseptics incl. dressings containing antibiotics or antiseptics in the four weeks prior to inclusion

 Patients who have been taking systemic antibiotics in the two weeks prior to inclusion

 Patients who have been taking systemic corticoids or cytostatics within the three months prior to inclusion

 Patients with unbalanced diabetes at the discretion of the investigator

 Patients with a known allergy to one of the components in Biatain Argent® or Biatain

 Patients who are already taking part in another clinical study

 Patients who are pregnant or breastfeeding


The Dose of Radioactive Iodine Needed to Ablate the Thyroid Remnant Left Behind After Thyroidectomy

Summary: The thyroid cells take up iodine, and radioactive iodine is commonly used to irradiate residual thyroid tissue and thyroid cancer following surgical removal of the thyroid gland (thyroidectomy). A whole body radioactive iodine scanning is usually carried out after thyroidectomy to assess the amount of thyroid tissue left behind at surgery (that might still contain cancer), and to evaluate the presence of iodine avid lesions elsewhere in the body (that might be cancer metastases). A large dose of radioactive iodine is often given, still the optimal iodine dose to ablate the thyroid remnant after surgery is not known. In this study, two radioactive iodine doses are compared in the ablation of the thyroid remnant, a smaller (1110 MBq) dose and a larger (3700 MBq) dose. The study participants are randomly allocated using a 1:1 ratio to receive either the smaller or the larger radioactive iodine dose. These treatments are compared for safety, adverse effects, and the need for subsequent repeat treatments. The individual absorbed radiation doses are measured. The study hypothesis is that fewer repeat radioiodine treatments might be needed after the larger dose, but the larger dose might be associated with a higher frequency of adverse events.
Inclusion criteria: inclusion criteria:

 Total or near total thyroidectomy performed for papillary or follicular thyroid cancer

 R0-1 resection, no macroscopic cancer left behind at surgery

 Physically and emotionally able to undergo radioiodine treatment

 A written informed consent

Exclusion criteria: :

 Pregnancy

 Physical or psychiatric illness that may deteriorate during the isolation period required by radioiodine therapy


The Hospital Volume Relationship in Appendicectomy Outcomes

Summary: Background~Appendicitis is a common condition which represents a significant resource burden for the Scottish National Health Service (NHS). It is unknown whether there are significant differences in Scottish appendicectomy (appendectomy) outcomes which may be explained by hospital volume. In many studies, hospital procedural volume has been shown to be predictive of surgical outcomes.~Aims~The aim of this study is to compare appendicectomy outcomes in Scotland as they vary by hospital procedural volume.~Methods~This research study is a retrospective observational enquiry which will utilise administrative data from the Information Services Division (ISD) of NHS National Services Scotland. Patient episodes will be identified by a procedure codes for appendicectomy. A 10 year period will be studied, from January 2001 to December 2010.~Primary outcome measures will be risk-adjusted 30 day/inpatient mortality, 30 day readmission rate, 30 day re-operation rate, length of stay and negative appendicectomy rate.
Inclusion criteria: inclusion criteria:

 All patients, of all ages, undergoing appendicectomy (OPCS code H01) during the time period January 2001 - December 2010.

Exclusion criteria: :

 Patients undergoing appendicectomy for whom this is incidental to a more major abdominal procedure.

 Patients non-resident in Scotland


European Survey of Non-Variceal Upper Gastro Intestinal Bleeding (NVUGIB)

Summary: The aim of this study is to assess the current management strategies in a pan-European real-life setting to uncover the unmet need in this area: non-variceal gastrointestinal bleedings.
Inclusion criteria: inclusion criteria:

 Patients admitted to the hospital or inpatients with an overt non-variceal upper GI bleed manifesting as hematemesis/coffee ground vomiting, melena, hematochezia, as well as other clinical/laboratory evidences of acute blood loss from the upper GI tract

 Evidence that an upper GI endoscopy was performed

 The complete medical record is available for study related hospitalization.

Exclusion criteria: :

 NA

['Non-variceal Upper Gastrointestinal Bleeding', 'Gastrointestinal Ulcer', 'Gastrointestinal Hemorrhage']


Effects of Intensive Robot-assisted Therapy in Patients With Subacute Stroke

Summary: Robot-assisted training (RT) devices developed to date have a significant impact on stroke rehabilitation. Several research groups have developed the robotic devices and examined their efficacy on improving upper limb function after stroke. All these robotic devices have been applied in stroke rehabilitation and their efficacy are evaluated, but the scientific evidence for the mechanisms of RT-induced recovery, the optimal treatment intensity, and the impact on physiological responses is still lacking.~This trial is to examine (1) the immediate effects of treatment intensity in RT on sensorimotor impairments and functional performance in patients with subacute stroke; (2) the long-term benefits of treatment intensity in RT by conducting a 6-month follow up evaluation; and (3) the effects of RT on cortical/movement reorganization as well as on the physiological markers of inflammation, oxidative stress, and erythrocyte deformability. These overall findings will help better understanding of the efficacy of RT on functional outcomes, brain and movement reorganization, and physiological markers.
Inclusion criteria: inclusion criteria:

 first episode of unilateral stroke

 time since stroke less than 3 months, i.e., acute or subacute stage

 initial motor part of upper limb of FMA score ranging from 10 to 40, indicating severe to moderate movement impairment

 no serious cognitive impairment (i.e., Mini Mental State Exam score > 23)

Exclusion criteria: :

 pregnant or breastfeeding women

 aphasia that might interfere with understanding instructions

 major health problems or poor physical conditions that might limit participation

 currently participation in any other research. Potential participants will be also excluded if they have any contraindication to fMRI scanning including claustrophobia, seizures, the presence of pacemaker, mental elements (e.g., steel nails) inside the body or in the eyes, and excessive obesity.

['RT', 'Conventional rehabilitation (CR)']


Synergetic B-cell Immodulation in SLE

Summary: The present study investigates the potential of a new therapeutic approach in lupus nephritis combining rituximab (anti-CD20) and belimumab (anti-BAFF). The main goal of the study is to assess the reduction (and seroconversion) of pathogenic autoantibodies, to evaluate clinical improvement and assess the safety and feasibility of long-term B-cell depletion.
Inclusion criteria: inclusion criteria:

 age 18 years,

 American College of Rheumatology (ACR) diagnosis of SLE (1997 revised criteria, see appendix 1)

 Severe SLE flare at screening (see also section 5.2.3.2.), defined as a situation in which 1 or more of the following criteria are met:

 Increase in SLEDAI (SLE Disease Activity Index) with 12 or more points

 New or worse SLE-related activity of major organs, i.e.: central nervous system (CNS-) SLE (includes NPSLE), vasculitis, nephritis, pericarditis and/or myocarditis, myositis, thrombocytopenia < 60, hemolytic anemia < 4.4mmol/L (=7.0g/dL).

 Refractory disease, defined as persisting or progressive disease activity (SLEDAI > 6 points) despite conventional immunosuppressive treatment and 1 or more of the following criteria:

 failure of the initial induction treatment at six months, for which a switch to another induction therapy regime has already been carried out;

 intolerance or contraindication for cyclophosphamide and mycophenolate mofetil (MMF);

 exceeding a cumulative dose of 15 gram of cyclophosphamide;

 a second relapse within two years after start of the initial induction therapy

 a relative contraindication for high-dose oral or intravenous (iv) prednisone, such as avascular osteonecrosis, previous psychosis on corticosteroids, osteoporosis and/or severe obesity (BMI =35 kg/m2).

 ANA seropositivity, as defined by a positive ANA-titer = 1:80, before and at screening :

 Positive test results from 2 independent time points within the study screening period; OR

 One positive historical test result and 1 positive result during the screening period. Historical documentation of a positive test of ANA (eg, ANA by HEp-2 titer, ANA by ELISA) must include the date of the test.

 Anti-DNA seropositivity, as defined by a positive anti-dsDNA serum antibody = 30 IU/mL, before and at screening:

 Positive test results from 2 independent time points within the study screening period.

 One positive historical test result and 1 positive result during the screening period. Historical documentation of a positive test of anti-dsDNA (eg, anti-dsDNA by Farr assay or ELISA) must include the date of the test.

 Immune-complex mediated complement usage, as defined by:

 a low C3 serum level = 0.9 g/L; OR

 a low C4 serum level = 95 mg/L; OR

 a reduced activation of the classical pathway < 75%

 Use of effective contraception

Exclusion criteria: :

 Active pregnancy, as proven by a positive urine beta-HCG (human chorionic gonadotropin) test or a positive serum beta-HCG

 Significant B-cell depletion (peripheral B-cell counts < 60x10E6)

 Significant hypogammaglobulinemia (IgG < 8.0 g/L)

 Immunization with a live vaccine 1 month before screening

 Active infection at time of screening, as follows:

 Hospitalization for treatment of infection within previous 2 months of day 0 of the study

 Use of parenteral (intravenous of intramuscular) antibiotics ( including anti-bacterial, anti-viral, anti-fungal or anti-parasitic agents) within previous 2 months of day 0 of the study


Clinical Validation of Lophius Biosciences Kit T-Track® CMV in Allo-HSCT Recipients

Summary: This study in a cohort of allo-HSCT recipients aims to validate the suitability of an improved T-Track® CMV assay to assess the functionality of CMV protein-reactive effector cells and its suitability to determine cut-off values mediating protection from recurrent CMV reactivations in allo-HSCT recipients.~Lophius T-Track® CMV represents a highly standardized and sensitive diagnostic tool to assess the functionality of a network of clinically relevant CMV-reactive effector cells. It is based on the stimulation of peripheral blood mononuclear cells (PBMC) with activated immunodominant CMV proteins, pp65 and IE-1, and the subsequent quantification of CMV-specific CMI (spot forming colonies) using a highly sensitive IFN-γ ELISpot.
Inclusion criteria: inclusion criteria:

 Patients receiving an allogeneic hematopoietic stem cell transplantation being either CMV seropositive or receiving a graft from a CMV seropositive donor or both, donor and recipient are CMV seropositive (D+/R-, D-/R+, D+/R+)

 Patients receiving a first allogeneic hematopoietic stem cell graft

 Patient at least 18 years of age

 Written informed consent

Exclusion criteria: :

 Seronegativity for CMV both for patient and donor (D-/R-)

 Patients receiving standard anti-CMV prophylaxis

 Patients receiving a haploidentical allogeneic hematopoietic stem cell graft

 Patients receiving an umbilical cord blood graft

 Patients treated with Alemtuzumab (e.g. Campath)

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

 Lack or withdrawal of informed consent

 Patient is unable to comply with the visit schedule in the protocol


PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)

Summary: The purpose of this study is to evaluate the effect of Low Molecular Weight Heparin (LMWH) (Fragmin, dalteparin) versus Unfractionated Heparin (UFH) on the primary outcome of proximal leg Deep Vein Thrombosis (DVT) diagnosed by compression ultrasound, and the secondary outcomes of Pulmonary Embolism (PE), bleeding, Heparin-Induced Thrombocytopenia (HIT), and objectively confirmed venous thrombosis at any site.
Inclusion criteria: inclusion criteria:

 Patient is >/= 18 years of age

 Actual body weight is >/= 45 kg

 Admission to ICU expected to be >/= 72 hours in duration

Exclusion criteria: :

 Neurosurgery within last 3 months

 Ischemic stroke within last 3 months

 Intracranial hemorrhage within last 3 months

 Systolic Blood Pressure >/= 180mm Hg, Diastolic Blood Pressure >/= 110mm Hg for >/= 12 hours requiring vasoactive drug infusion

 Major hemorrhage within last week unless definitively treated

 Coagulopathy as defined by INR >/= 2 times upper limit of normal [ULN], or PTT >/= 2 times ULN, at time of screening

 Thrombocytopenia defined as platelet count </= 75 x 109/L, at time of screening

 Other heparin contraindications (e.g., HIT, pregnancy, lactating)

 Contraindication to blood products (e.g., Jehovah's Witness)

 Unable to perform lower limb ultrasound (e.g., bilateral above the knee amputation, or severe distal extremity burns)

 Limitation of life support, Life expectancy </= 14 days, or palliative care

 Contamination (e.g., >/= 3 doses of LMWH during this ICU admission)

 Lack of informed consent

['LMWH (Fragmin, dalteparin)', 'Unfractionated Heparin']

LMWH (Fragmin
dalteparin)
Unfractionated Heparin

['Critical Illness', 'Deep Venous Thrombosis']


Rapid Intravascular Cooling in Myocardial Infarction as Adjunctive to Percutaneous Coronary Intervention

Summary: Rapid MI-ICE-Pilot is designed to demonstrate the safety and efficacy of the Celsius Control™ System (CCS) endovascular catheter to reduce the infarct size resulting from acute anterior myocardial infarction when used in combination with cold saline as an adjunct to immediate percutaneous coronary intervention (PCI) in patients with an occluded infarct-related artery.
Inclusion criteria: inclusion criteria:

 Each eligible patient must meet the following inclusion criteria :

 Have ECG evidence of ongoing acute anterior myocardial infarction, involving a large area of myocardium, as defined by the following ECG criteria: a. Anterior infarct: ST-segment elevation >0.2mV measured 0.08 sec after the J point in 2 or more anatomically contiguous precordial leads, V1 through V4; and/or >0.2mV in lead V5 V6

 Present to the RAPID MI-ICE site within six (6) hours of the onset of acute cardiac ischemic signs or symptoms (such as chest pain or pressure, arm or jaw pain, dyspnea, nausea/vomiting, or syncope)

 Be a candidate for PCI and have PCI planned as the immediate intervention.

 Be willing and able to comply with study procedures, including returning for the MRI scan at 4 ±2 days and return for the clinical examination on Day 30

 Provide written informed consent prior to the initiation of study-specific procedures

 Be in Killips Class I

Exclusion criteria: :

 Patients are not eligible for the study if they meet one or more of the following criteria:

 Age less than eighteen (<18) years of age

 Age greater than seventy-five (>75) years of age

 Are pregnant

 Have a suspected aortic dissection

 History of a prior anterior myocardial infarct or prior large myocardial infarct.

 The suspected etiology of myocardial infarction is primarily related to substance abuse (e.g., cocaine, methamphetamine, etc.)

 Acute administration of a thrombolytic agent for the qualifying MI

 If (during the screening process) the determination is made by site-study personnel that initiation of cooling prior to diagnostic coronary angiography is technically not feasible for any reason (should the patient be randomized to the Hypothermia Arm), the prospective subject should not be enrolled

 Require an immediate surgical or procedural intervention other than PCI (e.g. CABG)

 Present in cardiogenic shock or with end-stage cardiomyopathy

 Have undergone at least ten (10) minutes of cardiopulmonary resuscitation (CPR) prior to presentation to the PCI facility

 History of previous MI with known, pre-existing, anterior pathologic Q-waves

 History of surgical coronary artery revascularization (e.g., CABG, MIDCAB, or OPCAB)

 Recent stroke (within 3 months)

 Active bleeding, coagulopathy, or other contraindication to the placement of a heparin-coated 14F central venous catheter via a 14F femoral venous introducer sheath (e.g., known history of heparin induced thrombocytopenia, or IVC filter)

 Contraindications to hypothermia, such as patients with known hematologic dyscrasias which affect thrombosis (e.g., cryoglobulinemia, sickle cell disease, serum cold agglutinins) or vasospastic disorders (such as Raynaud's or thromboangitis obliterans)

 Personal or familial history of malignant hyperthermia

 Known end-stage renal disease (ESRD; e.g., on dialysis, or status-post renal transplant), known hepatic failure (e.g., cirrhosis, or acute hepatitis), or any other contraindication to receiving meperidine (such as use of MAO inhibitors within previous 14 days, history of seizures, history of hypersensitivity to meperidine, etc.) [Note: Patients with a contraindication to buspirone administration may be enrolled but should not be given buspirone as part of the anti-shivering regimen.]

 Any other acute or chronic condition which the Investigator believes will unacceptably increase the risk of study participation or interfere with study procedures and assessments

 Deemed unsuitable by the investigators to participate in the study.

 Signs of cardiogenic shock or other signs of significant heart failure such as rales over the lungs

 Active or recent (within 1 month prior to study enrollment) participation in another investigational clinical research study

['Endovascular cooling by the Celsius Control System', 'Standard of care']

['Acute Anterior Myocardial Infarction']


IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Post-stroke Spasticity of the Upper Limb

Summary: IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free from complexing proteins, i.e. free from proteins other than the active toxin. Injected into the muscle, incobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used for treatment of various neurological conditions. This study will investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in the treatment of post-stroke spasticity of the upper limb.
Inclusion criteria: Main inclusion criteria:

 Female or male patients ≥ 18 years

 ≥ 6 months since the last stroke, diagnosed by an appropriate health care professional (e.g., neurologist)

 Focal spasticity with ≥ 2 points on the Ashworth Scale in the wrist flexors with clinical pattern Flexed Wrist

 Focal spasticity with ≥ 2 points on the Ashworth Scale in the fingers flexors with clinical pattern Clenched Fist

 For pre-treated patients only: source documentation of the most recent injection session with Botulinum Toxin and sufficient therapeutic response for Flexed Wrist and Clenched Fist

 For pre-treated patients only: the most recent injection with Botulinum Toxin must have been maximal 50 Units BOTOX® or 200 Units Dysport® or 2000 Units Neurobloc® (type B preparation) per each of these flexors: carpi ulnaris, digitorum superficialis, digitorum profundus

 For pre-treated patients only: the most recent injection with Botulinum Toxin must have been maximal 60 Units BOTOX® or 240 Units Dysport® or 2400 Units Neurobloc® (type B preparation) for flexor carpi radialis

 Main
Exclusion criteria: :

 Spasticity of any other origin than stroke

 Previous treatment with Botulinum Toxin of any serotype and for any body region within the 4 months prior to Screening (Visit 1, Day -7)

 Planned concomitant treatment with Botulinum Toxin of any serotype and for any body region

 Previous or planned treatment with phenol- or alcohol-injection in the target limb

 Previous surgical treatment of spasticity in the target muscle(s)

 Fixed contracture, defined as severe restriction of the range of joint movement on passive stretch

 Severe atrophy of the target limb muscles


The Effect of Oseltamivir Treatment on the Yield of Polymerase Chain Reaction Test for Confirmed Influenza Infection

Summary: The purpose of this study is to determine the duration of viral shedding in hospitalized patients with influenza virus, treated with oseltamivir.
Inclusion criteria: inclusion criteria:

 clinical presentation that suggest influenza virus infection, including sudden onset of high fever, cough, headache, muscle and joint pain, severe malaise, sore throat and runny nose,

 positive to influenza virus by PCR test

 anti viral treatment was indicated

Exclusion criteria: :

 Immune compromised patients: patients after solid organ transplant, post bone marrow transplantation, with inherited or acquired immune deficiency, or patients treated chronically with immunosuppressive drugs.

 Pregnant women.

 Patients who were treated with oseltamivir in the previous 6 months


Pharmacology of Aminophylline for Acute Kidney Injury in Neonates

Summary: Acute kidney injury (AKI) in critically ill neonates is common and associated with significant morbidity and mortality. No targeted therapeutic treatment strategies have been established for AKI in neonates. Within a clinical pharmacokinetic and pharmacodynamic conceptual framework, this project will examine the medication aminophylline as a potential treatment approach for AKI.
Inclusion criteria: inclusion criteria:

 Neonate < 3 months post natal age

 Diagnosed with acute kidney injury (AKI)

 Receiving aminophylline for AKI treatment as per local standard of care.

Exclusion criteria: :

 Presence of anatomical renal anomaly based on postnatal evaluation of the patient (hydronephrosis, multicystic kidney, renal agenesis, renal dysplasia, polycystic kidney, or obstructive uropathy)

 Patient on renal replacement therapy

 Major genetic abnormalities (trisomy 13, 18 or 21).


Postpartum Anemia and Postpartum Depression

Summary: Postpartum anemia (PPA) and Postpartum depression (PPD) are common afflictions affecting women after childbirth. Both disorders have a significant impact on women's health and functional status. Despite common symptoms and characteristics, a link between these entities has not been adequately studied. The objective of this study is to determine whether postpartum anemia is an independent risk factor for the development of postpartum depression. This prospective cohort study will include all women delivered by elective term cesarean delivery. Hemoglobin and iron levels will be measured, standardized questionnaires for assessment of PPD, functional status and lactation will be administered before discharge and at 3 & 6 weeks post partum. Hemoglobin levels at each time point will be analyzed for correlation with depressive symptoms, functional status and lactation success.
Inclusion criteria: inclusion criteria:

 Women after term elective cesarean section

Exclusion criteria: :

 age < 16 years, preterm (< 37 weeks) delivery, multiple gestation, symptomatic anemia necessitating blood transfusion, significant fetal anomalies or infant not discharged with mother for other reason, preexisting severe chronic maternal illness, preexisting maternal depression and/or current use of antidepressants, other psychiatric illness (e.g. bipolar disease, schizophrenia) or preexisting hemoglobinopathy


Study on COPD Corticosteroid-induced Hyperglycemia on Clinical Outcome in Patients With COPD

Summary: Hyperglycemia is a common complication of corticosteroid (cortisone) therapy. It is estimated that more than a third of patients with chronic pulmonary disease (COPD) exacerbation (16). Despite its frequency, the impact of corticosteroid-induced diabetes on clinical outcome and mortality is not known. A computerized search of biomedical journal literature from MEDLINE, PubMed, and Ovid from 1966 to 2006 provided very little information on the prevalence and outcome of corticosteroid-induced diabetes in patients with COPD. Therefore, the present study aims to evaluate the impact of corticosteroid-induced diabetes on clinical outcome in patients with COPD exacerbation. We will perform a retrospective chart review of all patients admitted to the hospital with COPD exacerbation from 1/01/05 to 06/30/06 at Grady Memorial Hospital. Medical records of all patients with COPD exacerbation treated with corticosteroids will be analyzed. Data on demographics, laboratory values, mortality rate, rate of hypoglycemic events, length of stay, as well as disposition at discharge will be analyzed.
Inclusion criteria: inclusion criteria: Patients admitted with COPD exacerbation
Exclusion criteria:


The Visualization of Uncertainty in Clinical Diagnostic Reasoning for Pulmonary Embolism

Summary: Medical reasoning is a form of inquiry that examines the thought processes involved in making medical decisions. When physicians are faced with patients' symptoms or signs, their thought processes follow either direct shortcuts to suspect a diagnosis or go into a deeper and more analytic process to reach a diagnosis. The second pathway is less prone to biases and errors. This study explores whether the use of an interactive visual display of probabilities of pulmonary embolism generated from positive or negative test results will increase the adherence to evidence based guidelines in the diagnosis of pulmonary embolism.
Inclusion criteria: inclusion criteria:

 Medical students, University of Calgary, in clerkship who finished at least 4 weeks of a block of medicine rotation at any hospital site.

 First year subspecialty or Internal Medicine residents.

 Practicing physicians in the subspecialties of Internal Medicine or Emergency Medicine.

Exclusion criteria: :

 Physicians in the subspecialty of Haematology or Respiratory

['Visualized pulmonary embolism computer task model', 'Didactic review lecture']

['Pulmonary Embolism', 'Diagnostic Uncertainty', 'Clinical Reasoning', 'Evidence Based Medicine', 'Visualization of Uncertainty']

Pulmonary Embolism
Diagnostic Uncertainty
Clinical Reasoning
Evidence Based Medicine
Visualization of Uncertainty


REnal Sympathetic dEnervaTion as an a Adjunct to Catheter-based VT Ablation

Summary: Despite significant advances in the management of ventricular arrhythmias through the use of ICD therapy, AADs, and catheter-based ablation strategies, considerable challenges remain. The optimal method for the prevention of recurrent VT following catheter ablation remains unclear. RSDN may be an effective tool for preventing ventricular arrhythmias, and associated ICD therapies, by reducing central sympathetic tone, catecholamine levels, and the renin-angiotensin- aldosterone system and promoting ventricular remodeling. Although RSDN has been shown to reduce the recurrence of VT in a case report of 2 patients suffering from electrical storm, to date no large prospective randomized study has evaluated the impact of RSDN in the prevention of recurrent VT in patients following catheter ablation of VT with ischemic or non-ischemic ventricular dysfunction. This study will specifically evaluate the safety and efficacy of adjunctive RSDN in the prevention of ICD therapy in patients with ischemic or non-ischemic ventricular dysfunction who are to receive a catheter-based VT ablation.
Inclusion criteria: inclusion criteria:

 ≥ 18 years of age

 Structural heart disease (post-MI, dilated cardiomyopathy, sarcoid myopathy, hypertrophic cardiomyopathy, chagas-related cardiomyopathy, etc.)

 Planned for catheter-based ablation of VT

 All patients will have an existing ICD

 Accessibility of renal vasculature (determined by renal angiography)

 Ability to understand the requirements of the study

 Willingness to adhere to study restrictions and comply with all post- procedural follow-up requirements

Exclusion criteria: :

 MI or CVA within 30 days

 Coronary Artery Bypass Graft (CABG) within 30 days of this procedure

 Known renovascular abnormalities that would preclude RSDN (eg, renal artery stenosis)

 GFR <30 ml/min (unless receiving dialysis)

 Life expectancy <1 year for any medical condition

 Any condition resulting in a contraindication to anticoagulation (e.g. GI bleeding)

 Inability to give informed consent

 Known pregnancy or positive -HCG within 7 days of procedure.

['Renal sympathetic denervation', 'VT ablation alone']

Renal sympathetic denervation
VT ablation alone


Resolution of Comorbidities, Safety and Efficacy of Greater Curvature Plication in Obese Patients.

Summary: Various gastric restrictive procedures have evolved over the years but abandoned due to poor long term weight loss, food intolerance or severe gastroesophageal reflux. Laparoscopic gastric plication or laparoscopic greater curvature placation ( LGCP) has recently been done as an alternative to the other restrictive procedures. But the short and long term safety and efficacy outcomes of LGCP is not well documented in current literature. American society of metabolic and bariatric surgery ( ASMBS) guidelines state that LGCP procedures should be considered investigational at this time and should be performed under a study protocol with third party oversight (e.g. IRB) to ensure continuous evaluation of patient safety and to review adverse events and outcomes.~The objective of this study will be to demonstrate feasibility , short term and long term safety and efficacy of LGCP . This will be done by achieving gastric restriction by infolding of stomach and thereby achieving good weight loss .
Inclusion criteria: inclusion criteria:

 Subject is willing to give consent and comply with evaluation and treatment schedule;

 18 to 65 years of age (inclusive);

 Have a BMI > 27 with one or more significant co-morbid medical conditions which are generally expected to be improved, reversed, or resolved by weight loss. These conditions may include but are not be limited to -

 Hyperlipidemia

 Type 2 diabetes

 Mild obstructive sleep apnea

 Hypertension

 Osteoarthritis of the hip or knee

 Agree to refrain from any type of weight-loss drug (prescription or OTC) or elective procedure that would affect body weight for the duration of the trial;

 HbA1C < 11%

 For subjects who have Type 2 diabetes, the anti-diabetic medication regimen is no more complex than oral metformin plus one oral sulfonylurea plus once daily insulin injection.

 Ability to self pay for the procedure and follow up.

Exclusion criteria: :

 Previous malabsorptive or restrictive procedures performed for the treatment of obesity;

 Scheduled concurrent surgical procedure, with the exception of SOC liver biopsy;

 Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery;

 Any condition which precludes compliance with the study;

 History or presence of pre-existing autoimmune connective tissue disease

 Use of prescription or over the counter weight reduction medications or supplements within thirty days of the Screening Visit or the duration of study participation.

 Psychiatric disorders that may affect compliance with the clinical trial, including dementia, active psychosis, severe depression requiring > 2 medications, or history of suicide attempts. Any condition which places the subject at undue risk for the procedure (surgeon's discretion).

['Laparoscopic Greater Curvature Plication']


NGAL, an Early Predictive Marker of Acute Kidney Injury After Cardiac Surgery in Neonates and Infants

Summary: Urinary NGAL has been shown to be an early marker of acute kidney injury (AKI) following paediatric cardiac surgery (2 hours off pump). Previous studies showed that an early increase of urinary NGAL following cardiopulmonary bypass was predictive of AKI. Several studies included heterogeneous populations of children undergoing cardiac surgery, but NGAL has not been studied in neonates after open heart surgery, neither has been identified the threshold for accurate prediction of severe AKI requiring renal replacement therapy.~The aim of this observational cohort study is to describe postoperative kinetics of urinary NGAL in neonates and to identify the threshold for accurate prediction of severe AKI requiring renal replacement therapy in neonates and infants undergoing cardiac surgery
Inclusion criteria: inclusion criteria :

 term neonates and infants undergoing heart surgery with cardiopulmonary bypass

 parents received written information

Exclusion criteria:  :

 preoperative documented kidney injury

 parents not informed, opposed


Intra-articular Tranexamic Acid in the Reduction of Blood Transfusions in Primary Total Hip and Total Knee Arthroplasty

Summary: This is a randomized, double blinded, controlled trial in patients undergoing elective Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA). The study group will receive intra-articular Tranexamic Acid (TXA) while the control group will receive normal saline placebo.
Inclusion criteria: inclusion criteria:

 with osteoarthritis

 scheduled for elective primary unilateral THR or TKR

 provided informed consent

 can read, write and speak English

Exclusion criteria: :

 history of arterial or venous thromboembolic disease (myocardial infarction, symptomatic ischemic heart disease, atrial fibrillation, cerebrovascular accident, deep-vein thrombosis, pulmonary embolus, or thrombogenic cardiac valvular disease or rhythm disease)

 pre-operative Hg of <120 g/L

 Known allergy to Tranexamic Acid

 Coagulation disorder

 Acquired disturbances of color vision

 Hepatic insufficiency, any history of liver disease

 Renal insufficiency (on dialysis)

 Preoperative prophylactic use of antiplatelet or anticoagulant therapy such as Clopidogrel, Warfarin, dabigatran or Rivaroxaban. This does not include low dose Aspirin (81mg)

 Patients with a history of subarachnoid hemorrhage [20]

 Simultaneous bilateral THA or TKA

 Any contra-indication for spinal anesthesia

 Allergy to Celecoxib, which will be the only nonsteroidal anti-inflammatory drugs (NSAID) used in the multi-modal analgesia regime.

 Retinal vein or retinal artery occlusion

 Female on oral contraceptive pills and/or premenopausal

 Concurrently taking hydrochlorothiazide, desmopressin, sulbactam-ampicillin, carbazochrome, ranitidine and/or nitroglycerin for the duration of the surgery.


Does Long-Term Natalizumab (NTZ) Therapy Normalize Brain Atrophy Rates and Quality of Life (QOL) in Relapsing Remitting Multiple Sclerosis (RRMS)?

Summary: Primary Aims: To determine how effective long term Natalizumab (NTZ) therapy is in slowing the progression of whole brain atrophy. Whole brain atrophy rates will be measured through magnetic resonance imaging (MRI) scans and compared between patients with Multiple Sclerosis (MS) who have been using NTZ for at least 2 years versus age and gender-matched healthy controls. The primary outcome will be whole brain atrophy rate measured as the percent change in brain volume (PBVC) over a two-year period.~Primary hypothesis:~The investigators hypothesize that long term (>2 years) NTZ therapy will slow the rate of whole brain atrophy in patients with Multiple Sclerosis (MS) (as measured by percent change in brain volume), reaching a whole brain atrophy rate similar to that of non-MS controls (a true disease activity free state).
Inclusion criteria: inclusion criteria:

 18-55 inclusive years of age at the time of informed consent

 Diagnosis of relapsing multiple sclerosis as defined by the 2010 revised McDonald criteria

 Currently taking Tysabri

Exclusion criteria: :

 Systemic steroid users

 comorbidities that could confound MRI outcomes


Occult Paroxysmal Atrial Fibrillation in Non-Cryptogenic Ischemic Stroke

Summary: The purpose of this study is to determine the incidence of paroxysmal atrial fibrillation (AF) in ischemic stroke patients who have a presumed known stroke etiology other than atrial fibrillation.
Inclusion criteria: inclusion criteria:

 Patients with a recent ischemic stroke or transient ischemic attack (TIA) with brain infarction on brain imaging.

 No history of atrial fibrillation or finding of atrial fibrillation on standard inpatient monitoring (electrocardiogram, telemetry, 24-hour Holter monitor)

 Have a presumed stroke etiology: Lacunar or small vessel thrombosis, extra-cranial or intracranial atherosclerotic stenosis or dissection, arteriopathy or vasculitis, hypercoagulable state, aortic arch plaque with or without mobile elements, or evidence of a low-risk cardiac source (e.g., patent foramen ovale with or without atrial septal aneurysm and with or without evidence of venous thromboembolic source).

 Have virtual CHADS2 score ≥3 or

 Have 2 or more of the following co-morbidities: obstructive sleep apnea, coronary artery disease, (Chronic Pulmonary Obstructive Disease (COPD), hyperthyroidism, Body Mass Index> 30, prior myocardial infarction, prolonged PR interval (>175 ms) or renal impairment (GFR 30-60).

 Patient or legally authorized representative who is willing to sign written consent form.

 Patient is ≥40 years old (patients younger than 40 years old have a very low likelihood of having atrial fibrillation and are therefore excluded from the study).

 Patient can have the device implanted within 7 days of the incident ischemic event

Exclusion criteria: :

 Documented history of AF or atrial flutter.

 Evidence of a high-risk cardiac source of embolism (Left Ventricular or Left Atrial thrombus or smoke, emboligenic valvular lesion or tumor)

 Untreated hyperthyroidism.

 Myocardial infarction or coronary bypass grafting within 1 month prior to the stroke/TIA.

 Valvular disease requiring immediate surgical intervention.

 Permanent indication for anticoagulation at enrollment.

 Permanent oral anticoagulation contraindication.

 Already included in another clinical trial that will affect the objectives of this study.

 Life expectancy is less than 1 year.

 Pregnancy. Urine or serum pregnancy test is required for women of child bearing potential to exclude pregnancy.

 Patient is indicated for implant with a pacemaker, implantable cardioverter-defibrillator, CRT device, or an implantable hemodynamic monitoring system

 Patient is not fit, or is unable or unwilling to follow the required procedures of the Clinical Investigation Plan.

 Cryptogenic Stroke: A stroke/TIA will be considered cryptogenic if no cause is determined despite extensive inpatient workup according to the standard diagnostic protocol at North Shore University Hospital.

['Reveal LINQ Insertable Cardiac Monitor']


Prospective Study of Children and Adolescents With Craniopharyngioma

Summary: The present investigation is a prospective, multicenter study evaluating craniopharyngioma patients' prognoses following the various currently-practiced therapeutic strategies.Primary goals of the study are to establish quality standards and compare the various therapy strategies with respect to their effectiveness and impact on the quality of life of treated patients. A stratified randomization of two treatment arms will be conducted with respect to timing of postoperative irradiation for the subgroup of patients ≥5 years of age whose tumors are incompletely resected. The researchers will investigate whether an immediate, postoperative irradiation is superior to progression-contingent irradiation based on alterations to quality of life (PEDQOL) from the time randomization is initiated (3rd month post op) to 3 years after randomization. Progression-free survival and overall survival will be examined as closely-related subgoals.Postoperative data will be evaluated via a surveillance study for all complete resection patients as well as for those patients under 5 years of age regardless of their resection grade.
Inclusion criteria: inclusion criteria:

 Diagnosed with craniopharyngioma for the first time

 Age at diagnosis 18 years or less of age

 Agreement from patient's parents or legal guardian as well as the patient

 Criteria for inclusion in randomization study

 Histological diagnosis of craniopharyngioma

 Age at diagnosis 18 years or less of age

 Age at primary surgery over 5 years of age

 Incomplete primary resection

 Reference radiological confirmation of an incomplete resection

 Agreement from patient's parents or legal guardian as well as the patient

Exclusion criteria: :

 Age at diagnosis over 18 years of age No QoL measurement for randomization (3 months after surgery).


Urinary Incontinence in an Inpatient Rehab Unit

Summary: Urinary incontinence (UI) is a very common condition in women, with estimates of prevalence varying from 10% to 40% in most studies and showing a gradual increase with age. UI is a serious medical problem that can lead to urinary tract infections, low back pain, respiratory disorders, pressure sores, and an increased risk of falls. It also leads to social problems, creating embarrassment and negative self-perception for those who suffer from it. Women with urinary incontinence find themselves isolated and relatively inactive. A wide range of treatments has been used in the management of women's UI, including conservative interventions, pharmaceutical intervention, and surgery. A Cochrane Review from 2008 stated that pelvic floor muscle training (PFMT) is better than no treatment for UI and supports the recommendation that PFMT should be the first treatment line in conservative management programs for women with UI. Recently, there have been a few articles published that looked at the effectiveness of treating UI in a group-like setting with both behavioral modifications and pelvic floor exercises. One study was able to prove that group training of behavioral modification helped to reduce UI severity, increase pelvic floor strength, and reduce voiding frequency when compared to a control group.~All of the studies cited were performed in community-dwelling persons with out-patient services and interventions. Dr. Fitzgerald and her colleagues from The Rehabilitation Institute of Chicago (RIC) were able to confirm in a poster presentation that many patients admitted to an inpatient rehabilitation facility do have UI. In 2005, out of 403,697 Medicare beneficiaries admitted to a rehab hospital, 24% were incontinent. These studies were able to illustrate that UI affects all diagnoses. UI was shown to make a significant contribution to patient outcomes independent of functional status at admission. It is also a large determinant of discharge destination. In the United Kingdom in 2004, 62% of incontinent stroke patients were discharged to a sub acute home with only 5% placement for continent stroke survivors. Another study determined that urinary incontinence after having a stroke predicted a higher likelihood of an adverse outcome when controlled for age, type of stroke, and length of hospital stay. May, et. al., was able to state while in an acute rehab setting that patients with spinal cord injuries ranked bowel and bladder care, along with skin care, as most important in an education class with 12 different topics. This shows that patients find bladder function a large priority in their care, even in an in-patient setting. In the poster presentation mentioned above, many patients with UI in an acute care rehab setting do not improve Functional Independence Measure (FIM) status from admission to discharge. Currently there is no research available for the treatment of UI in an acute care rehab hospital, though it has been shown to be an issue with many of those admitted. So the question arises, Would addressing urinary incontinence with physical therapy interventions and behavioral modifications improve incontinence in this population during the acute rehab stage?
Inclusion criteria: inclusion criteria:

 Inclusion includes English-speaking women over the age of 18 who have been admitted to the Rehabilitation Institute of Chicago with reports of urinary incontinence in the past 3 months. Those who report yes to the screening questions who fit the above criteria will be screened by the principal investigator to ensure they fall into the criteria.

Exclusion criteria: :

 Non-English speaking women under the age of 18, or those that do not give consent to participate in the study will not be enrolled. Also excluded will be any woman who has any chance of being pregnant or having an active urinary tract infection. No women with active infection lesions, unknown vaginal bleeding or those who have never had any kind of pelvic examination will be included in the study. Other


Search a Correlation Between Lp(a) Rate and TFPI Activity in Obese Patients With Chest Pain Like Angina

Summary: Atherosclerotic cardiovascular disease is a leading cause of mortality in our countries. Clinically, symptoms could be chest pain suggesting stable angina. Atherosclerosis is influenced by cardiovascular risk factors which obesity (Body Mass Index>30). Obesity is associated with an increase risk of cardiovascular complications.~Lipoprotein(a) is regarded as an independent risk factor for premature cardiovascular disease. Lp(a) is composed of low-density lipoprotein - like particle bound to glycoprotein molecule: apolipoprotein(a). Plasma levels are determinated to more than 90% by genetic factors (no significant influence of statin, weight, lifestyle factor: diet, exercise). Two study with few patients have found that aspirin lowers serum Lp(a) levels. Elevated Lp(a) is a risk factor for recurrent coronary events in obese patient.~Atherosclerosis is associated with imbalance of coagulation. TFPI (tissue factor pathway inhibitor) is the earliest inhibitor of the blood coagulation process, natural direct inhibitor of tissue factor. In-vitro, TFPI activity is inhibited by high Lp(a) .~The aim of this study is to research reverse association between Lp(a) and TFPI activity in obese patient with chest pain like stable angina suggesting atherosclerotic heart disease and effect of aspirin.
Inclusion criteria: inclusion criteria:

 Major

 Men

 Obese BMI>30

 No aspirin treatment before inclusion

 Coronary exploration: coronary angiography or tomography coronary angiography

 Chest pain like stable angina

Exclusion criteria: :

 Women

 Severe hepatic insufficiency

 Inflammatory disease

 Neoplasia

 Protein S deficiency

 Aspirin treatment 10 days before inclusion

 Oral anticoagulant treatment at inclusion

 Heparin or low molecular weight heparin treatment at inclusion


Effect of Systemic Hypoxia and Hyperoxia on Retinal Oxygen Saturation

Summary: Adequate perfusion and oxygenation is essential for the function of the inner retina. Although it is known that oxygen tension is very well autoregulated in the retina, the physiological mechanisms behind this regulation process are not fully explored. The development of new instruments for the non-invasive measurement of oxygen tension in retinal vessels now allows for the more precise investigation of these physiological processes. The current study seeks to evaluate the retinal oxygen saturation in healthy subjects while breathing different oxygen mixtures to achieve a hypoxic and a hyperoxic state.
Inclusion criteria: inclusion criteria:

 Men and women aged between 18 and 35 years

 Nonsmokers

 Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

 Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant

 Normal ophthalmic findings, ametropy < 3 Dpt.

Exclusion criteria: :

 Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except oral contraceptive)

 Symptoms of a clinically relevant illness in the 3 weeks before the first study day

 Presence of any form of anemia

 Blood donation during the previous 3 weeks

 Pregnancy

['100% oxygen breathing', '15% oxygen in N2 breathing', '12% oxygen in N2 breathing']

100% oxygen breathing
15% oxygen in N2 breathing
12% oxygen in N2 breathing

['Retinal Oxygenation', 'Retinal Blood Flow']


Effects of Nitric Oxide and Nitroglycerin in Patients With Sickle Cell Anemia

Summary: Sickle cell anemia is the most common genetic disease affecting African-Americans. About 1 in every 1000 African-Americans has the disease and 1 in every 12 carry the genes that could be passed on to their children. People with sickle cell anemia have abnormal hemoglobin, the molecules responsible for carrying oxygen in the blood. The abnormal hemoglobin can cause damage to the red blood cells. The damaged red blood cell may then stick in the blood vessels and cause pain and injury to organs. Some of the complications caused by the sticking of blood cells are called acute pain crisis and acute chest syndrome (ACS).~Nitric oxide (NO) is a gas that has been proposed as a possible therapy for the ACS complication of sickle cell anemia. Studies have shown that NO may favorably affect sickle cell hemoglobin molecules, thereby improving blood flow through small vessels.~This study is designed to evaluate the effects of NO, when taken in combination with a drug called nitroglycerin on patients with sickle cell anemia and normal volunteers. The effects of these two drugs only last while the patient is receiving them. Researchers hope the information learned from this study will help to develop new therapies for sickle cell anemia.
Inclusion criteria: inclusion criteria:

 Males or females 18 to 65 years of age.

 Diagnosis of sickle cell disease (electrophoretic documentation of SS homozygosity is required) or identification as a normal volunteer.

 Hematocrit greater than 18% (with an absolute reticulocyte count greater than 100,000/ml).

 Hematocrit 18-21% (with an absolute reticulocyte count greater than 100,000/ml): Only 100 ml of blood may be drawn. The study subject may be re-entered in the study after four weeks (with repeat full screening labs).

Exclusion criteria: :

 Clinically unstable sickle cell anemia defined by the following:

 Having greater than two acute pain crises in the last two months; on hydroxyurea or butyrate therapy any time in the last 12 months; or blood transfusion within last three months, or % hemoglobin A greater than 20%.

 Age less than 18 years or greater than 65 years.

 Current pregnancy or lactation.

 Inability to exercise the anterior tibialis muscle.

 Active cigarette smoker-defined as the inhalation of smoke from any tobacco product in the last one month.

 Medical conditions: diabetes mellitus; coronary artery disease; peripheral vascular disease; migraine headaches in the last 12 months; history of previous CVA or stroke; or creatinine greater than 1.0 mg/dL.

 MRI Exclusions: cardiac pacemaker or implantable defibrillator; aneurysm clip; neural stimulator (e.g. TENS-Unit); any type of ear implant; or metal in the eye (e.g. from machining); any implanted device (e.g. insulin pump, drug infusion device); or any metallic foreign body, shrapnel, or bullet.

 Hematocrit less than or equal to 18 percent: will not be eligible for the study; may return for evaluation at a later date.

 No aspirin or non-steroidal anti-inflammatory drugs (no NSAIDS and caffeine the day of the study.) Patients on opiates and acetaminophen will not be excluded.

 Patients taking Viagra will be excluded from the study.


Eltrombopag Phase III Study In Chinese Chronic ITP Patients

Summary: This randomized, double-blind and open-label phase III study aimed to determine the efficacy, tolerance and safety of eltrombopag in Chinese chronic primary immune thrombocytopenia (ITP) adult subjects. This study was be conducted in Chinese adult chronic ITP subjects who had not responded to or had relapsed after previous treatment of ITP, including first line therapy and /or splenectomy.~The primary objective of this study was to determine the efficacy of oral eltrombopag as a thrombopoietic agent treating previously treated chronic Chinese ITP patients compared to placebo. The secondary objective was to assess the safety and tolerability of eltrombopag when administered for 6 weeks to previously treated adult chronic ITP patients compared with placebo. In addition, the long-term efficacy and safety of eltrombopag treatment was also evaluated in the 24-week extension open-label phase after the double-blind phase as one of other study objectives. If the subject benefited from the eltrombopag treatment based on the investigator's discretion, the subject could continue on eltrombopag treatment until the commercial launch of eltrombopag in China. Furthermore, to understand the pharmacokinetics (PK) profile of eltrombopag and to explore the relationship between the PK and pharmacodynamics (PD) (platelet response), a PK/PD analysis was embedded in this phase III study and conducted in the same patient population who participated this phase III study.
Inclusion criteria: inclusion criteria:

 Subject is ≥18 years old.

 Diagnosed with ITP for at least 12 months prior to screening, and have a platelet count of <30 X109/L on Day 1 (or within 48 hours prior to dosing on Day 1).

 Patients who have no response or relapsed after splenectomy. Or patients who have not been splenectomised and have either not responded to one or more prior therapies (except splenectomy), or who have relapsed prior therapy.

 Previous therapy for ITP including rescue must have been completed at least 2 weeks prior to randomization.

 Subjects treated with maintenance immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month.

 No pre-existing cardiac disease within the last 3 months. No arrhythmia known to increase the risk of thrombolic events (e.g. atrial fibrillation), or patients with a Corrected QT interval (QTc) >450msec or QTc >480 for patients with a Bundle Branch Block.

 No history of clotting disorder, other than ITP.

 A complete blood count (CBC), within the reference range, with the following exceptions:

 Platelets <30×109/L on Day 1 (or within 48hours of Day 1) is required for inclusion,

 Hemoglobin: females and males 10.0 g/dl are eligible for inclusion,

 Absolute neutrophil count (ANC) ≥1500/µL (1.5×109/L) is required for inclusion

 Blood chemistry test result no exceed normal by more than 20%. Total albumin must not be below the lower limit of normal (LLN) by more than 10%.

 Subject is non-childbearing potential of childbearing potential and use acceptable methods of contraception from two weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study.

Exclusion criteria: :

 Patients with any prior history of arterial or venous thrombosis, AND ≥ two of the following risk factors: hormone replacement therapy, systemic contraception (containing estrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension, cancer, hereditary thrombophilic disorders (e.g., Factor V Leiden, ATIII deficiency, antiphospholipid syndrome, etc).

 Any clinically relevant abnormality, other than ITP,which in the opinion of the investigator makes the subject unsuitable for participation in the study.

 Female subjects who are nursing or pregnant at screening or pre-dose on Day 1.

 History of alcohol/drug abuse or dependence within 12 months of the study.

 Treatment with thrombopoietin or an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication.

 Subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist.

 Subject has consumed aspirin, aspirin-containing compounds, salicylates, anticoagulants, quinine or non-steroidal anti-inflammatories (NSAIDs) for >3 consecutive days within 2 weeks of the study start and until the end of the study.

 Consumption of any herbal or dietary supplements, excluding vitamin or mineral supplements, within 1 week of the study start.

 History of platelet aggregation that prevents reliable measurement of platelet counts.

 An abnormality in bone marrow examination result, other than ITP, identified on the screening examination, which in the opinion of the investigator makes the subject unsuitable for participation in the study (e.g. ≥MF-2 according to EU consensus scale [Thiele, 2005]) or suggests another primary diagnosis (e.g. Thrombocytopenia is secondary to another disease).

 Any laboratory or clinical evidence for HIV infection.

 Any clinical history for hepatitis C infection; chronic hepatitis B infection; or any evidence for active hepatitis at the time of subject screening. Laboratory test shows positive serology for Hepatitis C or Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.

 Patients expected to require rescue on Day 1 of the study.

['Purpura, Thrombocytopenic, Idiopathic and Hepatitis C']

Purpura
Thrombocytopenic
Idiopathic and Hepatitis C


Efficacy and Safety of Dihydroartemisinin/Piperaquine (Artekin®) for the Treatment of Uncomplicated Malaria in Peru

Summary: In Peru, Mefloquine plus Artesunate (MAS3), is the current first line treatment for P. falciparum malaria in the Amazonian Region, and has proved its efficacy against multi-resistant P. falciparum parasites, but several side effects have been reported. Dihydroartemisinin-piperaquine (DHA-PPQ) is a new co-formulated and well tolerated ACT, increasingly used in Southeast Asia where it has proved to be highly effective against Plasmodium falciparum malaria. We tested the efficacy, safety and tolerability of DHA-PPQ in patients with uncomplicated P. falciparum malaria. A RCT to evaluate DHA-PPQ was carried out, between 2003 and 2005. Patients with uncomplicated P. falciparum malaria were randomly allocated to receive either DHA-PPQ or MAS3 with a 63-day follow-up period. Five hundred twenty two patients were included in the analysis, 262 were allocated to receive DHA-PPQ, and 260 to receive MAS3. The two groups were comparable at baseline in demographic and clinical characteristics. The mean time for parasite clearance into the DHA-PPQ group was 32.0 hours and 35.5 hours in the MAS3 group. Twenty-four hours after the first dose, the proportions of patients whose cleared parasitaemia were 67.2% in the DHA-PPQ group, and 58.1% in the MAS3 group (RR 1.25, [95% CI 1.03-1.52], p = 0.017). All patients were able to clear parasites within 72 hours after the first dose. The mean time for fever clearance was 28.0 and 29.5 hours in DHA-PPQ and MAS3 group respectively. (P= 0.69). Twenty-four hours after the first dose, 85.5% and 83.1% of patients cleared fever in the DHA-PPQ and MAS3 group respectively (p>0.05). The Adequate Clinical and Parasitological Response (ACPR), PCR adjusted, were 97.7% and 99,2% for the DHA-PPQ and MAS3 group respectively, (RR 0.99, 95% CI [0.86-1.13], P = 0.88). No Early Treatments Failures were reported in any group. In the DHA-PPQ group, according to the PCR adjusted results, 6 subjects had Late treatment Failures. In the MAS3 group, two Late Treatment Failures was reported. The frequency of adverse events was significantly lower in patients treated with DHA-PPQ than in those treated with MAS3.~DHA-PPQ proved to be a highly effective antimalarial drug for the treatment of P. falciparum malaria and suitable for use in the Peruvian Amazon region. It also has the advantage of being better tolerated. In terms of cost, DHA-PPQ is cheaper and more affordable than MAS3 and should be considered for the National Antimalarial Drug Policy in Perú.
Inclusion criteria: inclusion criteria:

 Age: 5 - 60 years old

 Fever (axillary temperature equal or higher than 37,5 °C) or history of fever in the previous 24 hours

 Monoinfection with P. falciparum, with parasitic density between 1,000 and 200,000 par/µl

 Informed consent provided by patient or parent or legal tutor

 •
Exclusion criteria: :

 Mixed malaria infection

 Pregnancy or breastfeeding to child ≤ 6 months of age

 One or more danger signs or any sign of severe or complicated malaria

 A concomitant severe disease

 History of treatment with mefloquine in the last 60 days or chloroquine, primaquine or quinine within the 14 days before the present episode

 History of neuropsychiatric disease

 History of hypersensitivity reactions to artemisinins or mefloquine

 History of splenectomy

['Dihydroartemisin-piperaquine', 'Mefloquine + Artesunate']

Dihydroartemisin-piperaquine
Mefloquine + Artesunate


Effect of Local Application of Boron on Diabetic Foot Ulcers

Summary: Boron as a naturally occurring element has some metabolic and inflammatory actions. The antibacterial activity against gram negative bacteria is also known. Boron deficiency is shown to be related with impaired wound bone healing in rats. Therefore, special wound care formulas containing boron may have some positive effect on wound healing of the patients with diabetic foot ulcers.
Inclusion criteria: inclusion criteria:

 diabetic food ulcer classified byInternational Working Group of the Diabetic Foot (IWGDF) as grade 1 and 2

Exclusion criteria: :

 previous vascular surgery on the side that the ulcer is present

 uncontrolled diabetes mellitus

 presence of osteitis, abscess, osteomyelitis, gangrene on the side that the ulcer is present

 diabetic food ulcer classified byInternational Working Group of the Diabetic Foot (IWGDF) as grade 3


Cancer Immune Therapy for the Treatment of Refractory Solid Tumours of Childhood

Summary: This is an un-blinded Phase 1 study in which 21 patients suffering from solid advanced paediatric malignancies (14 sarcoma and 7 non-sarcoma patients) are treated with AV0113, an anti-tumour immune therapy with autologous Dendritic Cells (DCs) loaded with tumour cell lysates, in order to investigate its safety and feasibility.~For obtaining a clearer picture of AV0113's utility in the treatment of bone and soft tissue sarcoma, a long-term (LT) follow-up investigation of the 14 sarcoma patients, which will be treated using the AV0113 Dendritic Cell Cancer Immune Therapy (DC-CIT) technology is planned, in order to gather first evidence for a potential LT effect of DC-CIT with AV0113.~Furthermore, a comparison of the 14 sarcoma patients treated with AV0113 DC-CIT with a cohort of matched historic control patients that were treated using standard of care will be conducted. It is planned to analyse 42 historic control sarcoma patients that will be matched for disease, recurrences, relapses etc.
Inclusion criteria: inclusion criteria:

 inclusion criteria for the safety and feasibility testing of AV0113

 Male and female patients with a malignant neoplasia shall be eligible for this protocol provided they have no more conventional treatment options and have measurable disease. There is no age limit for participation in this study provided that the tumour is typical for the group of refractory solid neoplasias of childhood.

 Patients must not be HIV-positive.

 Patients must have primary tumour tissue or cells available at sufficient number to allow treatment according to the protocol.

 Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form.

 inclusion criteria for patients included in the long-term follow up and comparison with historic controls

 Patients suffering from bone or soft tissue sarcoma that received treatment with AV0113 or are documented in the database of the Medical University Vienna's Department of Orthopaedics.

 At least one disease recurrence after first CR or worse disease condition (e.g.: never reached CR).

 Diagnosis between 1992-2003 and/or inclusion time point during the years 2000-2004.

 Availability of date of death or of confirmation that patient is still alive (for the currentness of confirmation that patients are still alive only the time span from 1 April 2014 to 1 April 2015 is accepted).

 Patients not older than 27 years at their ITP.

Exclusion criteria: :


Abdomen CT and Open Appendicectomy：New Diagnostic and Surgical Procedures

Summary: The traditional open appendectomy in the clinical effect is not prefect, and for a long time there is no measurable improvement. The application of abdomen CT before surgery provides a new approach to the incision and new perception.~In a randomized controlled trial of modified incision versus traditional incision. Length of hospital day was the primary terminus, while operating time, postoperative complication, scar and time to resume normal activity and work as secondary terminus.
Inclusion criteria: inclusion criteria:

 patients with a clinical diagnosis of acute appendicitis

Exclusion criteria: :

 children under 14 are not included

['The application of abdomen CT', 'traditional incision']

The application of abdomen CT
traditional incision

['Wound Infection', 'Complication', 'Scar']


Radiofrequency-Guided Localization in Patients With Abnormal Breast Tissue Undergoing Lumpectomy

Summary: This pilot clinical trial studies the use of the radiofrequency-guided localization in patients with abnormal breast tissue undergoing lumpectomy (a type of breast-sparing surgery). The radiofrequency identification localization system consists of an implantable radiofrequency identification tag and a hand-held radiofrequency reader to mark abnormal breast tissue before surgery and later surgically retrieve them. Radiofrequency-guided localization may make it easier to find and remove abnormal breast tissue during lumpectomy.
Inclusion criteria: inclusion criteria:

 Have had stereotactic or ultrasound-guided biopsy with marker placement

 Have a lesion or biopsy marker that is visible under ultrasound

 Have a surgical target =< 6 cm from the skin when lying supine

 Have a discreet surgical target

 Have a lesion in which the center/focal area is defined

 Have the ability to understand and the willingness to sign a written informed consent document

 Eastern Cooperative Oncology Group (ECOG)/Karnofsky performance status will not be used as an inclusion criterion

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

Exclusion criteria: :

 Require more than one localization needle for localization of the surgical target (bracket localization)

 Have undergone previous open surgical biopsy, lumpectomy, or mastectomy in the operative breast

 Have a prosthesis/implant in the operative breast

 Have a cardiac pacemaker or defibrillator device

 Be contraindicated for surgery

 Be pregnant

['Lumpectomy', 'Questionnaire Administration', 'Radiofrequency-Guided Localization']

Lumpectomy
Questionnaire Administration
Radiofrequency-Guided Localization


A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)

Summary: The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with active arthritis that have poor response to methotrexate.
Inclusion criteria: inclusion criteria:

 Diagnosis must have been before the patient's 16th birthday

 Disease duration of at least 6 months before study entry

 Must have 5 or more joints with active arthritis

 Must be taking a stable dose of methotrexate 10-30 mg/meter squared (patients with body surface area [BSA] 1.67 square meter or more must be taking a minimum of 15 mg/week of methotrexate)

 May take a stable dose of prednisone less than 10 mg/day 4 weeks prior to entry or may take a stable dose of NSAIDS (non-steroidal anti-inflammatory drugs) 2 weeks prior to entry

 Must have qualifying laboratory values at the first visit.

Exclusion criteria: :

 Have known allergies, hypersensitivity, or intolerance to golimumab or similar therapeutics

 Are pregnant or breast-feeding, or planning a pregnancy or fathering a child within 6 months after the last study agent administration

 Have initiated DMARDS and/or immunosuppressive therapy within 4 weeks prior to study initiation

['CNTO 148 (Golimumab)', 'Placebo', 'Methotrexate']

CNTO 148 (Golimumab)
Placebo
Methotrexate


Collaborative Systematic Overview of Randomised Controlled Trials of Beta-Blockers in the Treatment of Heart Failure

Summary: Several large trials have shown that beta-blocker treatment reduces the risk of death and hospital admission in patients with symptomatic heart failure. Unfortunately, survey data suggests relatively poor utilisation of beta-blockers, despite ample evidence for good tolerability. Additionally there are several important unanswered questions, such as clinical efficacy for specific sub-populations (women, the elderly and patients with diabetes or other co-morbidities) and the effect of beta-blockers in combination with other medications. Previous meta-analyses, based on published tabular data, have been conducted although this approach has important biases and limitations.~We plan to perform a carefully conducted systematic review of individual patient data from the major randomised trials of beta-blockers in heart failure. The goals of this collaborative project are to clarify the overall efficacy of beta-blockers and identify sub-groups that show particular benefit, thereby increasing the use of beta-blockers, reducing adverse clinical outcomes and the high costs associated with this condition.
Inclusion criteria: inclusion criteria:

 Randomised control trials of beta-blocker versus control in patients with documented heart failure

 Unconfounded trials only (in which one treatment group differed from another only by the beta-blocker therapy of interest)

 Randomization process precluded prior knowledge of the next treatment (for example trials in which treatment allocation was alternate or based on odd or even dates would not be included)

Exclusion criteria: :

 Trial sample size of less than 300 patients


An Assessment of Rapid Streptococcal Tests in Community Clinics in Israel

Summary: There is a large over-use of antibiotics in family medicine, especially in upper respiratory tract infections.~This study is designed to determine if the use of rapid Streptococcal tests in primary care clinics can lower the rate of antibiotic use while not missing bacterial infections.
Inclusion criteria: inclusion criteria:

 sore throat

 at least two Centor criteria:

 fever > 38 deg C or history of fever

 enlarged cervical lymph nodes

 tonsillar exudate

 lack of cough

 age 3-14 years

Exclusion criteria: :

 antibiotic treatment in preceding 7 days

 no informed consent

['Pharyngitis', 'Streptococcus Pyogenes Infection', 'Streptococcus Pyogenes Identification']

Pharyngitis
Streptococcus Pyogenes Infection
Streptococcus Pyogenes Identification


Safety and Efficacy Study of Altabax Ointment in the Treatment of Secondarily Infected Atopic Dermatitis

Summary: Skin infections may complicate the treatment of atopic dermatitis.The use of topical ointments has become very important to avoid the use of oral antibiotics. There is little supporting literature regarding the use of topical antibiotics in secondarily infected atopic dermatitis.~This study will investigate the safety and effectiveness of Altabax ointment use in treating secondarily infected atopic dermatitis caused by Staphylococcus aureus and Streptococcus pyogenes.
Inclusion criteria: inclusion criteria:

 Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline and practice a reliable method of contraception.

 Secondary infection of atopic dermatitis with S.aureus or S.pyogenes as the probable causative agent.

 An infected area less than or equal to 100 centimeters squared for subjects 18 years of age or older, or, 2% body surface area for subjects under 18 years of age.

 Skin Infection Rating Scale score greater than or equal to 8.

 Able to understand and comply with the requirements of the study and sign Informed Consent/Health Insurance Portability and Accountability Authorization Forms. Subjects under the legal age of consent must also have the written informed consent of parent or legal guardian.

Exclusion criteria: :

 Female subjects who are pregnant, trying to get pregnant, breast feeding or who are of childbearing potential and not practicing reliable birth control.

 Allergic to any component of the test medication.

 Clinical diagnosis of impetigo, folliculitis or minor soft tissue infection.

 Use of topical antibacterial medication to the study treatment area within 1 day of Visit 1.

 Signs of systemic infection or evidence of abcess or cellulitis at the site to be treated.

 Medical condition that,in the opinion of the investigator, contraindicates the subject's participation in the clinical study.

 Recent alcohol or drug abuse is evident.

 History of poor cooperation, non-compliance with medical treatment or unreliability.

 Participation in an investigational drug study within 30 days of Baseline Visit.

['Atopic Dermatitis', 'Secondary Infection']


Comparison of Low and Intermediate Dose Low-molecular-weight Heparin to Prevent Recurrent Venous Thromboembolism in Pregnancy

Summary: This is a randomized-controlled open-label trial comparing two different doses of low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the American College of Chest Physicians (ACCP), but it is not known which dose is more efficacious in preventing recurrent venous thromboembolism in pregnancy.~Patients enter the study and will be randomized as soon as a home test confirms pregnancy. LMWH will be administered until 6 weeks postpartum. Follow-up will continue until 3 months postpartum. Patients will be recruited by their treating physician, either an obstetrician or internist.
Inclusion criteria: inclusion criteria:

 Age: 18 years or older, and;

 Pregnancy confirmed by urinary pregnancy test, and;

 Gestational age < 14 weeks, and;

 Previous objectively confirmed VTE, either unprovoked, in the presence of use of oral contraceptives or estrogen/progestagen use, or related to pregnancy or the postpartum period, or minor risk factors (e.g. long distance travel, minor trauma).

Exclusion criteria: :

 Previous VTE related to a major provoking risk factor (e.g. surgery, major trauma or plaster cast immobilisation in the 3 months prior to VTE) as the sole risk factor, or;

 Indication for treatment with therapeutic dose anticoagulant therapy (e.g. treatment of acute VTE; permanent use of therapeutic anticoagulants outside of pregnancy), or;

 Inability to provide informed consent, or;

 Any contraindication listed in the local labelling of LMWH.

['Low dose nadroparin', 'Intermediate dose nadroparin', 'Low dose enoxaparin', 'Intermediate dose enoxaparin', 'Low dose dalteparin', 'Intermediate dose dalteparin', 'Fixed low dose tinzaparin', 'Intermediate dose tinzaparin']

Low dose nadroparin
Intermediate dose nadroparin
Low dose enoxaparin
Intermediate dose enoxaparin
Low dose dalteparin
Intermediate dose dalteparin
Fixed low dose tinzaparin
Intermediate dose tinzaparin

['Deep Venous Thrombosis', 'Pulmonary Embolism']

Deep Venous Thrombosis
Pulmonary Embolism


Rituximab in Auto-Immune Hemolytic Anemia

Summary: The hypothesis based on retrospective data is that, the rate of overall response-rate (PR + CR) at 1 year will be much higher in the rituximab arm (80%) than in the placebo arm (20%).Thirty four patients (17 in each arm) will be include (amendment n°6 - 15/10/2013) over a 3 year period (amendment n°3 - 11/12/2012).
Inclusion criteria: inclusion criteria:

 Age > 18 years

 AIHA defined at time of diagnosis by a Hgb level £ 10 g/dL, with a reticulocytes count > 120 109/L, signs of hemolysis (at least a haptoglobin level < 4 mg/L), and a positive direct antiglobulin test (DAT) ( IgG or IgG + complement pattern).

 Disease duration equal or less than 6 weeks at time of inclusion --> removed by amendment n°4 and substituted by :First episode of AIHA to hot antibody previously untreated or treated corticosteroids for less than 6 weeks.

 Patients with an associated autoimmune thrombocytopenia (Evans' syndrome) will be eligible for the study if the platelet count is over 30 x 109/L at inclusion.

 Normal level gammaglobulins in the serum (i.e. >5g/L) at inclusion.

 Absence of detectable lymph nodes on a total body CT-scan (to be performed before inclusion if not performed at diagnosis).

 Effective means of contraception during treatment and for six months after completion of treatment for all women of child bearing age

 Negative serum pregnancy test within 14 days prior to study entry.

 Written informed consent

Exclusion criteria: :

 Previous treatment with rituximab

 AIHA diagnosed and treated more than 6 weeks prior to inclusion removed by amendment n°4 and substituted by AIHA relapsed or newly diagnosed but treated with corticosteroids for more than 6 weeks

 Ongoing immunosuppressive therapy (other than corticosteroids) or previous treatment administered within 2 weeks prior to the beginning of the study treatment

 Non-Hodgkin Lymphoma (NHL) other than stage A chronic lymphoid leukemia

 Previous or concomitant malignancy other than basal cell or squamous cell carcinoma of the skin, carcinoma-in-situ of the cervix, or other malignancy for which the patient had not been disease-free for at least 5 years.

 Autoimmune disorder such as SLE with at least one extra-hematological manifestation requiring a treatment with steroids and/or immunosuppressive drugs.

 Any other associated cause congenital or acquired hemolytic anemia (except thalassemia trait or heterozygous sickle cell anemia).

 Negative DAT or DAT positive with isolated anti-C3d pattern related to the presence of a monoclonal IgM with cold agglutinin properties.

 Positive HIV test and/or hepatitis virus C infection and/or positive hepatitis B virus surface antigen (HbsAg).

 Neutrophils count < 1,000/mm 3 at inclusion.

 Impaired renal function as indicated by a serum creatinine level > 2 mg/d

 Inadequate liver function as indicated by a total bilirubin level > 2.0 mg/dL and/or an AST or ALT level > 2x upper limit of normal.

 New York Heart Classification III or IV heart disease.

 Previous history of severe psychiatric disorder or are unable to comply with study and follow-up procedures

 Pregnant or lactating women, or woman planning to become pregnant within 12 months of receiving study drug

 Absence of written informed consent.