TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults

Summary: This is a multinational, randomized (1:1), double blind, comparator-controlled, 2 parallel treatment group study in subjects equal to or over 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P). Each subject will receive either telithromycin, 400 mg over-encapsulated tablets, 800 mg once daily for 5 days or penicillin V 250 mg over-encapsulated tablets, 500 mg three times daily for 10days. Matching placebo capsules will be dispensed to maintain the blind between the treatment groups.A positive rapid identification test for streptococcal Group A antigen will be required for all subjects at Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture, identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.
Inclusion criteria: inclusion criteria:

 Age equal to or over 13 years;

 For female subjects, the following conditions are to be met:

 Subject is premenarchal or surgically incapable of bearing children,

 Subject is of childbearing potential and all of the following conditions are met:

 Have normal menstrual flow within 1 month before study entry,

 Have negative pregnancy test (urine pregnancy test sensitive to at least 50 mU/mL, and

 Must agree to use an accepted method of contraception throughout the study (if sexually active);

 Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes based on:

 A positive result from a rapid detection test for Group A streptococcal antigen and submission of a throat swab specimen for bacterial culture, identification, and antibiotic-susceptibility testing; and

 A sore and scratchy throat and/or pain on swallowing (odynophagia) together with at least 2 of the following clinical signs:

 Tonsil and/or pharyngeal erythema and/or exudate;

 Cervical adenopathy;

 Uvular edema;

 Fever

Exclusion criteria: :

 Symptoms that collectively suggest nonstreptococcal T/P (eg, laryngitis, coryza, conjunctivitis, diarrhea, cough);

 History of positive throat culture for Streptococcus pyogenes in the absence of clinical signs and symptoms of T/P;

 Infection of the deep tissues of the upper respiratory tract (eg, epiglottitis, retropharyngeal or buccal cellulitis, or abscess of the retropharynx, tonsil, or peritonsillar area) or of the suprapharyngeal respiratory tract and its connecting structures (eg, sinusitis, otitis media, or orbital/periorbital cellulitis);

 History of rheumatic heart disease;

 Known congenital prolonged QT syndrome;

 Known or suspected uncorrected hypokalemia (≤3 mmol/L [mEq/L) or hypomagnesemia or bradycardia (<50 bpm);

 Known impaired renal function, as shown by creatinine clearance ≤25 mL/min

 Myasthenia gravis;

 History of hypersensitivity or intolerance to macrolides, penicillins, or cephalosporins;

 Previous enrollment in this study or previous treatment with telithromycin;

 Children of the investigator or subinvestigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the protocol.

 Is currently being treated with systemic antibacterials or has been treated with systemic antibacterials within 14 days prior to enrollment;

 Has been treated with any investigational medication within the last 30 days;

 Has been treated with rifampicin, phenytoin, carbamazepine, or St. John's wort within the last 2 weeks.


The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Southern Europe The TRANS-South Study

Summary: Trafermin is a recombinant human basic fibroblast growth factor (bFGF; original development code, KCB-1), which is manufactured by genetic engineering using Escherichia coli by Kaken Pharmaceutical Co., Ltd. (Tokyo, Japan). Trafermin 0.01% cutaneous spray product kit consisting of a glass bottle containing lyophilized trafermin, a glass bottle with solvent for solution and a spray part to fit the glass bottle after reconstitution of the final product.~The investigators conduct a multinational, randomized, double-blind, placebo controlled, parallel-group, multicentre study consisting of a placebo run-in phase (2w), a treatment phase (max. 12w) and a follow-up phase (3mo+6mo). The primary objective of the study is to demonstrate a superior wound closure rate of diabetic foot ulcers (DFUs) of neuropathic origin after 12 weeks topical daily application of trafermin 0.01% spray compared with placebo, in addition to best local care (off-loading, dressings). Approximately 210 patients will be randomized and it is planned that this study will be conducted at approximately 30 investigational sites in an estimated 4 countries in Europe (Czech Republic,France,Hungary,Italy,).
Inclusion criteria: Selection Criteria

 Patients who fulfill all of the following criteria (and none of the
Exclusion criteria:  described below) are eligible to enter the placebo run-in phase of the study:

 Provide written informed consent to participate.

 Male or female patients age 18 years or older.

 Type 1 or 2 diabetes.

 A single full-thickness DFU that has been present for at least 2 weeks.

 DFU wound surface area below or equal 34 cm2 on the target foot.

 No exposure of bone in the target DFU.

 Neuropathy confirmed by loss of protective sensation to monofilament test (Semmes-Weinstein 5.07 monofilament).

 No predominant ischemia requiring further exploration or treatment, and confirmed by either:

 ABPI on the target leg ( >0.9;below or equal 1.3) or if ABPI is >1.3 or is not assessable,TBPI on target foot above or equal 0.7, OR

 ABPI on target leg (above or equal 0.7;below or equal 0.9) or if ABPI is >1.3 or is not assessable, TBPI on target foot <0.7, AND a toe blood pressure >40 mmHg

 inclusion criteria

 Patients who fulfill all of the following criteria are eligible for randomization:

 All of the selection criteria and none of the

['Diabetic Foot Ulcer of Neuropathic Origin']


The Role of Nicotine and Non-Nicotine Alkaloids in E-Cigarette Use and Dependence

Summary: The advent of electronic cigarette (e-cigarette) technologies represents one of the most significant developments in the last several decades, and provides a novel and promising strategy for substantially reducing the morbidity and mortality associated with smoking. However, serious concerns have been raised regarding the possibility that e-cigarettes will sustain a dependency on nicotine and that they may lead to continued use of conventional cigarettes known to be extremely harmful to health. Cigarette addiction critically involves a dependence on nicotine, but it is likely that other tobacco constituents contribute to dependence as well. Recent evidence suggests that non-nicotine tobacco alkaloids, or NNTAs (including anabasine, anatabine, nornicotine, and myosmine) may play a role in tobacco dependence. These alkaloids have been shown to augment the reinforcing effects of nicotine in animal models and to affect cravings in human smokers. E-cigarettes contain variable quantities of nicotine and NNTAs, but there is virtually no information available concerning the role of e-cigarette nicotine or NNTA content in influencing the concurrent use of cigarettes and e-cigarettes, when smokers attempt to switch from conventional combustible cigarettes to e-cigarettes. Additionally, it is not known whether the presence of nicotine and NNTAs in e- cigarettes may sustain dependence, making it difficult to relinquish these products. The proposed project will assess the acceptability, extent of switching behavior, and degree of dependence maintained when smokers are provided with e-cigarettes containing nicotine and NNTAs.
Inclusion criteria: inclusion criteria:

 Have no known serious medical conditions;

 Are 21-65 years old;

 Smoke an average of at least 10 cigarettes per day;

 Have smoked at least one cumulative year;

 Have an expired air CO reading of at least 10ppm;

 Are able to read and understand English.

 Potential subjects must agree to use acceptable contraception during their participation in this study. Potential subjects must agree to avoid the following during their participation in this study:

 Participation in any other nicotine-related modification strategy outside of this protocol;

 Use of tobacco products other than cigarettes, including pipe tobacco, cigars, snuff, and chewing tobacco;

 Use of e-cigarettes other than the ones provided during the study;

 Use of experimental (investigational) drugs or devices;

 Use of illegal drugs.

Exclusion criteria: :

 Actively seeking treatment for nicotine dependence;

 Uncontrolled high blood pressure (self-report);

 Coronary heart disease with symptoms (e.g., chest pain);

 Heart attack in the past year;

 Cardiac rhythm disorder (irregular heart rhythm with symptoms);

 Chest pain in the last month (unless history indicates a non-cardiac source);

 Symptomatic heart disorder such as heart failure;

 Advanced liver or kidney disease that requires medication or dialysis, paracentesis;

 Bleeding stomach ulcers in the past 30 days;

 Lung disease that requires oxygen;

 Major brain disorder (including stroke with residual deficit, brain tumor, and seizure disorder);

 Migraine headaches that occur more frequently than once per week;

 Recent, unexplained fainting spells;

 Diabetes with insulin use;

 Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);

 Other major medical condition (as determined by study medical provider);

 Diagnosis of thought disorder; such as bipolar disorder or schizophrenia;

 Psychiatric hospitalization within the past 12 months;

 Pregnant or nursing mothers;

 Use (within the past 7 days) of illegal drugs (or if the urine drug screen is positive for THC, Cocaine, Amphetamine, Opiates, Methamphetamines, PCP, Benzodiazepines, or Barbiturates), unless recent use of prescription opiates or benzodiazepines were taken for management of acute symptoms (e.g., tooth extraction, recent surgery, or sleep);

 Use of experimental (investigational) drugs within the past 7 days;

 Use of psychiatric medications including antidepressants and anti-psychotics may be permitted if the condition is stable (study medical provider discretion).

 Use of opiates, benzodiazepines, and muscle relaxants (unless taken for sleep or acute symptoms such as tooth extraction or recent surgery) within the past 7 days (study medical provider discretion);

 Use of Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine patch, nicotine replacement therapy, clonidine or any other smoking cessation aid within the past 30 days;

 Use of cigars, pipes, Hookah, dissolvable nicotine, snuff, chewing tobacco, or e-cigarettes within the past 7 days;

 Diagnosis of alcohol abuse or dependence or self-report of consuming more than 6 drinks on one occasion more than one day per week;

 Significant adverse reaction to nicotine patch in the past;

 Current or recent participation (in the past 30 days) in another smoking treatment study at our Center or another research facility;


Oral Ginkgo Biloba and Narrow Band UVB in the Treatment of Vitiligo

Summary: Vitiligo is a common chronic skin disease with 1-4% prevalence. It has a significant psychosocial impact on patients and society. Different treatment modalities with variable success rates are available.~Phototherapy is among the successful treatments but gives modest results. Some reports documented the usefulness of Ginkgo Biloba (GB) when used alone in Vitiligo treatment.
Inclusion criteria: inclusion criteria:

 Any Vitiligo patient (age 12 years and above) with non-segmental Vitiligo.

 Body surface area (BSA) involvement ≥ 3%.

Exclusion criteria: :

 Unable to consent

 Any topical, systemic or phototherapy for Vitiligo in the previous 2 months.

 Pregnancy, breast feeding.

 Liver or kidney disease.

 Epilepsy

 Bleeding disorder or anticoagulant treatment


Efficacy and Safety of Umbilical Cord Blood Injection for Critical Limb Ischemia

Summary: The purpose of this study is to determine whether treatment with umbilical cord blood stem cells will improve blood flow to the most severely affected leg of a participant with medically refractory and non-surgical peripheral vascular disease of the lower extremity.
Inclusion criteria: inclusion criteria:

 Atherosclerotic ischemic peripheral vascular disease or Thromboangiitis Obliterans with Critical Limb Ischemia (Fontaine stages III and IV)

 Participant must match either a or b

 Ankle brachial index (ABI) ≤ 0.7

 Doppler waveforms at posterior tibial artery and dorsalis pedis artery are monophasic with toe pressure < 30 mmHg.

 A non-surgical candidate for revascularization e.g. prior vascular reconstruction, inability to locate a suitable vein for grafting, diffuse multi- segment disease, or extensive infra-popliteal disease not amenable to a vascular graft.

 Age > 18 years old.

 The non-index leg may be treated only in the event and it full fills the same eligibility criteria and
Exclusion criteria:  used in this protocol for the treatment leg.

 Patients must be on maximal tolerated medical therapy for PVD including A) Cessation of smoking B) Referral to endocrinologist for control of HgA1c to < 7.0 mg/dl, control of hyperlipidemia with statins or other anti-hyperlipidemic drugs as indicated, control of hypertension as indicated C) Antiplatelet therapy with aspirin and / or cilostazol (unless medically contraindicated, e.g. bleeding or allergy)


Natural History of Noncirrhotic Portal Hypertension

Summary: Background:~- Noncirrhotic Portal Hypertension (NCPH) is caused by liver diseases that increase pressure in the blood vessels of the liver. It seems to start slowly and not have many warning signs. Many people may not even know that they have a liver disease. There are no specific treatments for NCPH.~Objectives:~- To learn more about how NCPH develops over time.~Eligibility:~- People age 12 and older who have NCPH or are at risk for getting it. In the past year, they cannot have had other types of liver disease that typically result in cirrhosis, liver cancer, or active substance abuse.~Design:~Participants will have 2 screening visits.~Visit 1: to see if they have or may develop NCPH.~Medical history~Physical exam~Urine and stool studies~Abdominal ultrasound~Fibroscan. Sound waves measure liver stiffness.~<TAB>- Visit 2:~Blood tests~Abdominal MRI~Echocardiogram~Questionnaire~Liver blood vessel pressure (hepatic venous portal gradient (HVPG)) measurement. This is done with a small tube inserted in a neck vein.~They may have a liver biopsy.~All participants will visit the clinic every 6 months for a history, physical exam, and blood tests. They will also repeat some of the screening tests yearly.~Participants with NCPH will also have:~Upper endoscopy test. A tube inserted in the mouth goes through the esophagus and stomach.~At least every 2 years: Esophagogastroduodenoscopy.~At least every 4 years: testing including HVPG measurements and liver biopsy.~Participants without NCPH will also have:~Liver biopsy and HVPG measurements to see if they have NCPH.~Every 2 years: abdominal MRI and stool studies.~The study will last indefinitely.
Inclusion criteria: inclusion criteria:

 Age 12 years or above, male or female

 Known diagnosis of NCPH, or to be at the risk for NCPH by virtue of underlying disease processes such as but not limited to; CGD, SCD, Mastocytosis, CVID, CF, and CHF.

Exclusion criteria: :

 Evidence of other forms of liver disease that typically result in cirrhosis.

 Evidence of active chronic Hepatitis B infection as defined by the presence of hepatitis B surface antigen (HBsAg) in serum and elevated HBV DNA (>10,000 IU/mL).

 Hepatitis C as defined by the presence of hepatitis C RNA in serum.

 Primary sclerosing cholangitis as defined by liver histology.

 Primary biliary cirrhosis as defined by cholestasis, +/- antimitochondrial antibody positivity and liver histology.

 Wilson s disease as defined by ceruloplasmin below the limits of normal and liver histology and urinary copper consistent with Wilson disease.

 Autoimmune hepatitis as defined by antinuclear antibody (ANA) of 3 EU or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy for autoimmune hepatitis.

 Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy or homozygosity for C282Y. Patients with iron saturation indices of >45% and serum ferritin levels of >300 ng/ml for men and >250 ng/ml for women will undergo genetic testing for hemochromatosis.

 Bile duct obstruction as suggested by imaging studies done within the previous six months.

 The presence of cirrhosis as demonstrated by liver biopsy.

 Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year (assessed during patient interviews by patient self-report).

 Evidence of hepatocellular carcinoma; either alpha-fetoprotein (AFP) levels greater than 50 ng/ml (normal <6.6ng/ml) and/or ultrasound (or other imaging study) demonstrating a mass suggestive of liver cancer.

 Evidence of Cholangiocarcinoma as suggested by liver histology.

 Any other severe condition, which in the opinion of the investigators would impede the patient s participation or compliance in the study.

 Inability to comply or give written informed consent.

['Cystic Fibrosis', 'Immunologic Deficiency Syndrome', 'Turner Syndrome', 'Congenital Hepatic Fibrosis', 'Idiopathic Non-Cirrhotic Portal Hypertension']


Effects of Aircraft Cabin Altitude on Passenger Comfort and Discomfort

Summary: Commercial aircraft passengers are exposed to atmospheric pressures ranging from the pressure found at ground level to that encountered in the external environment at 8,000 feet. There is some evidence in the medical literature that symptoms of acute mountain sickness can result from ascent to altitudes of 6,300 to 10,000 feet by unacclimated persons during the first few days following ascent, probably due to the hypoxia that results from breathing air at the reduced ambient pressures at altitude. The logical hypothesis that follows is that exposure to 8,000 feet could cause hypoxia sufficient to adversely affect the comfort and well being of some commercial aircraft passengers on prolonged flights. There is insufficient data in the literature to validate this hypothesis.~Exercise at sea level and at altitude reduces arterial oxygen levels. The logical hypothesis that follows is that the combination of moderate exercise and exposure to altitude could cause hypoxia sufficiently severe to adversely affect the comfort and well being of some people and that the combined effect of exercise and altitude on comfort and well being is greater than the effect of exercise or altitude alone. Again, there is insufficient evidence in the literature to substantiate this possibility.~The purpose of this investigation is to test these hypotheses.
Inclusion criteria: inclusion criteria: age 21 - 75

Exclusion criteria: :Height greater than 6'2, BMI greater than 45. Specified acute or chronic medical conditions -

 -


Ibuprofen as a Possible Preventer of Post Bronchoscopy Fever

Summary: Scientific background: Bronchoscopy is a procedure commonly performed in the management of persistent respiratory illness. In the last decades this exam has become a routine and safe procedure even in children and there are few side-effects. However, one known side effect is transient fever and even high fever a few hours after the bronchoscopy. This side effect is not dangerous but very uncomfortable for the patients and it would be interesting to try to reduce this phenomena. This fever is due to a release of cytokines during the broncho-alveolar lavage procedure and not to sepsis. In a previous study a single dose of dexamethasone was shown to prevent the fever post bronchoscopy with no apparent detriment to the child. It is well known that steroids are immunosuppressive. Even though the post-bronchoscopy fever is not caused by an infection, it seems preferable to use other anti-inflammatory drugs to fight this very inconvenient side effect.~Ibuprofen (Nurofen*) is known as an effective medication to reduce fever in infectious illnesses and is even considered as superior to paracetamol. It has no immunosuppressive effect and is usually well tolerated by children with very few side effects when taken in the normal therapeutic dose of 10mg/Kg. The investigators postulate that a dose of Nurofen prior to bronchoscopy could significantly reduce fever post bronchoscopy.
Inclusion criteria: inclusion criteria:

 under twelve years of age

 all patients undergoing bronchoscopy and bronchoalveolar lavage

Exclusion criteria: :

 children with immune deficiency

 allergy to NSAIDS

 previous exacerbation of asthma due to NSAIDS

 fever on the day of the examination

 current antibiotic treatment


Computerized Personal Interventions for Alzheimer's Patients

Summary: The purpose of this study is to determine whether the use of computerized systems in 2 common non pharmacological therapies (cognitive training and reminiscence therapy) will improve the cognitive function of patients with mild to moderate Alzheimer's disease (AD), or at least delay its deterioration. In addition, the investigators hypothesize that using the computerized systems will result in improved well-being of the patients and their main caregivers / family members, and in improved patient-caregiver and patient-family relations.
Inclusion criteria: inclusion criteria:

 Clinical diagnosis of Alzheimer's Disease

 MMSE score of 14-26

Exclusion criteria: :

 Visual impairment

 Auditory impairment

 Psychiatric disorders

['Reminiscence therapy', 'Cognitive training', 'No treatment']

Reminiscence therapy
Cognitive training
No treatment


Maggot Therapy for Wound Debridement

Summary: The main objective of the trial was to study the efficacy of bagged larvae on wound debridement in comparison to classical treatments. The secondary outcome was to assess wound healing, treatment related pain, microbiological modifications, adverse events, comfort of the dressing and duration of wound care. We performed a randomized, double-blind, multicenter, controlled, prospective phase III trial in three referral institutional centers of hospitalized care in Caen, Lisieux and Lyon, France. A total of 120 patients with a non-healing fibrinous wound ≤ 40cm2, less than 2cm-deep, and an ankle-brachial pressure index (ABPI) ≥ 0.8 were included, from March 2005 to December 2008. During two weeks´ hospitalization, patients received either Maggot Debridement Therapy (MDT, changes of bagged larvae twice a week) or classical treatments (mechanical debridement and classical dressings performed three times a week). At discharge, classical dressings were applied and a follow-up visit performed at D30. Main outcome measure was the comparison of the reduction of fibrin percentage on wounds treated with MDT and classical treatments at D15. The percentages of fibrin were measured using a computerized planimetry software package, Canvas (ACD Systems, British Columbia, Canada), which enables the quantification of color surface variations in a wound after manual delimitation (using a mouse) on a series of photographic images.
Inclusion criteria: inclusion criteria:

 patient between 18 and 90 years old

 patients with a non-healing fibrinous wound ≤ 40cm2 (pressure ulcer or venous ulcers

 pressure ulcers were less than 2cm-deep

 limb wounds were venous ulcers with an ankle-brachial pressure (ABP)≥ 0.8

 signed informed consent

Exclusion criteria: :

 patients pregnant or lactating

 patients with neuropathy

 patients perforant ulcer of the foot

 patients with dementia

['application of wound dressing made of bio-bags (vitapads) containing maggots', 'application of classical hydrogel/alginate wound dressing']


Extended Out-of-hospital Low-molecular-weight Heparin Prophylaxis Against DVT and PE in Patients Undergoing Major Lung Resection

Summary: Postoperative venous thromboembolism (VTE) is a significant health-care problem, resulting in significant morbidity, mortality and resource utilization. The true incidence is unknown, and may range from 1% to 15%. At the current time, the clinical practice of VTE prophylaxis in thoracic surgery includes administration of unfractionated or low molecular weight heparin starting at the perioperative period and finishing at the time of patients' discharge. In orthopaedic surgery, prolonged thromboprophylaxis beyond 10 days and up to 35 days has become the standard of care. There is a clear need to systematically evaluate the incidence of VTE after resection of lung malignancies and to evaluate the role of extended VTE prophylaxis in preventing Deep Vein Thrombosis (DVT) and pulmonary embolus (PE) after those major lung resections. This study will involve patients undergoing lung resection for malignancy at St. Joseph's Healthcare Hamilton and the University Health Network's Toronto General Hospital. The study will include 150 consecutively recruited patients. Study interventions will include Computed Tomography with pulmonary embolus (PE) protocol and bilateral extended leg Doppler Ultrasound for the detection of Deep Vein Thrombosis 30 days post-surgery.~In summary, this study is aimed at evaluating, for the first time in a prospective manner, the actual incidence of DVT and PE in patients undergoing major lung resections for malignancies. The knowledge gained in this study will be used to inform a future investigation involving a Randomized Controlled Trial (RCT) to compare current post-operative thromboprophylaxis with an extended 30-day prophylaxis protocol with the hope of providing an evidence-based practice change in VTE prophylaxis care for this high risk population.
Inclusion criteria: Patient inclusion criteria

 At least 18 years of age

 Either gender

 Diagnosed with resectable lung cancer or metastatic lung disease eligible to complete metastasectomy

 Undergoing one of the following surgeries: Segmentectomy, wedge resection, lobectomy, bilobectomy or pneumonectomy

 Competent to understand and sign consent documents

 Patient
Exclusion criteria:

 Known allergic or anaphylactic reaction to contrast dye, heparin or low molecular weight heparin (LMWH)

 Under current anticoagulation for venous thromboembolism or other medical conditions

 Known renal impairment, defined as creatinine clearance value of less than 55ml/min/m2 as calculated by the Cockroft-Gault method

 History of, or ongoing liver disease, manifested as ascites or previous peritoneal tapping for ascites

 Pregnant or planning to become pregnant

 Diagnosed or treated for VTE in the past 3 months prior to surgery

 Present or previous increase risk of haemorrhage

 History of previous HIT (heparin induced thrombocytopenia)

 Platelet count must be below 75,000

 Previously inserted Inferior Vena Cava Filter (IVC) filter.

['Venous Thrombosis', 'Pulmonary Embolism', 'Lung Neoplasms']

Venous Thrombosis
Pulmonary Embolism
Lung Neoplasms


A Prospective Study of Cyclophosphamide in Systemic Lupus Erythematosus Treatment

Summary: The purpose of this study is to compare the genotype-based personal prescription of cyclophosphamide with the traditional prescription.
Inclusion criteria: inclusion criteria:

 The American College of Rheumatology established eleven criteria in 1982,which were revised in 1997 as a classificatory instrument to operationalise the definition of SLE in clinical trials.

 Malar rash (rash on cheeks).

 Discoid rash (red, scaly patches on skin that cause scarring).

 Serositis: Pleurisy (inflammation of the membrane around the lungs) or pericarditis (inflammation of the membrane around the heart).

 Oral ulcers (includes oral or nasopharyngeal ulcers).

 Arthritis: nonerosive arthritis of two or more peripheral joints, with tenderness, swelling, or effusion.

 Photosensitivity (exposure to ultraviolet light causes rash, or other symptoms of SLE flareups).

 Blood-hematologic disorder-hemolytic anemia (low red blood cell count) or leukopenia (white blood cell count<4000/µl), lymphopenia (<1500/µl) or thrombocytopenia (<100000/µl) in the absence of offending drug. Hypocomplementemia is also seen, due to either consumption of C3 and C4 by immune complex-induced inflammation or to congenitally complement deficiency, which may predispose to SLE.

 Renal disorder: More than 0.5 g per day protein in urine or cellular casts seen in urine under a microscope.

 Antinuclear antibody test positive.

 Immunologic disorder: Positive anti-Smith, anti-ds DNA, antiphospholipid antibody, and/or false positive serological test for syphilis. Presence of anti-ss DNA in 70% of cases (though also positive with rheumatic disease and healthy persons).

 Neurologic disorder: Seizures or psychosis. For the purpose of identifying patients for clinical studies, a person has SLE if any 4 out of 11 symptoms are present simultaneously or serially on two separate occasions. In the meantime, the case has one of the following conditions or more;

 HIV (-);

 Signed the informed consent;

 Taking contraceptive measures during treatment period.

Exclusion criteria: :

 Poor compliance;

 With lupus mental damage complication, occurrence of epilepsy or unable to express subjective symptoms during the observation period.

 Taking drugs that affect cytochrome P450 2B6, cytochrome P450 3A4 and cytochrome P450 2C19, except corticosteroids.

 Abnormal liver function.


Epoprostenol in Pulmonary Embolism

Summary: You are admitted to hospital because of pulmonary embolism. You are treated with anticoagulants.~The investigators know that, despite this treatment, pulmonary embolism can be a threat especially if heart function is compromized.~The investigators investigate a well known study drug (epoprostenol) on top of regular treatment with anticoagulants, to see if heart function can be optimized
Inclusion criteria: inclusion criteria:

 acute (symptoms <24 hrs) with right ventricular dilatation (>30 mm end diastolic, systolic PAP > 50 mmHg,

 absence of right ventricular wall hypertrophy)

Exclusion criteria: :

 age below 18 years or above 70 years

 body mass index >35 kg/m2

 duration of symptoms >24 hours (since onset or acute increase in symptoms)

 severe circulatory shock (systemic blood pressure systolic <80 mmHg, or diastolic blood pressure <45 mmHg) or respiratory failure, requiring mechanical ventilation.

 patients who, in the opinion of the supervising physician, require thrombolytic therapy.

 severe pre-existent cardiopulmonary disease (heart failure, obstructive pulmonary disease, emphysema)

 atrial fibrillation

 refusal or inability to give informed consent


Exercise Behavior Among Young Adults Study

Summary: The rate of adult obesity in the United States has increased more than two times since 1970, and the rate of child-teen obesity has increased by four times. One of the antecedents of obesity is an inactive lifestyle. Exercise has been known to be associated with increases in both physical and mental health by increasing longevity, preventing risk of obesity, coronary heart disease, and hypertension, and increasing self-esteem and overall quality of life. The broad aim of the current study is to investigate the effectiveness of psychoeducational training to increase exercise activity initiation and maintenance in young adults.~The goal of this study is to compare three training approaches for college students to increase exercise behavior. One approach provides general information on the different types of exercises and benefits of engaging in exercise behavior after an initial questionnaire assessment session. A second approach includes the general exercise information and questionnaire assessment as well as training on how to create specific goal intentions (i.e., implementation intentions) to aid in exercise initiation. A third approach uses all the components of the second approach but also tests the utility of a personality-informed module by incorporating concepts from the theory of learned industriousness. It is expected that the third approach will be the most effective in helping participants initiate and maintain their exercise activities during the course of the study duration.
Inclusion criteria: inclusion criteria:

 be currently enrolled in full-time university coursework

 be between 18 and 24 years old

 understand and respond to screening questions in English

 be able to read at a Grade 6 level

 have adequate health, as assessed by having a body mass index between 18.5 and 29.9 (anyone with a BMI of 30+ is considered obese; National Heart, Lung, & Blood Institute, 2012) to ensure that regular, moderate to intense exercise activity will not negatively affect health

 identify as individuals who have tried to initiate and continue an exercise regimen sometime in the past but have been unable to maintain the activity

 indicate the desire to initiate physical activity at the current time

 be willing to attempt to maintain an exercise schedule during the three-week intervention period to which they will be randomly assigned

 be willing to participate in the 2-month and 6-month follow up periods

Exclusion criteria: :

 not already be meeting current USDHHS physical activity recommendations (i.e., at least 150 minutes of moderate-intensity exercise per week)

 not have major cognitive impairments (i.e., assessed by whether they can understand and respond adequately to all screening questions)

 not report consuming more than three (women) or four (men) alcoholic drinks per day (as this may interfere with their ability to engage in physical activity and confound study results)

 not be pregnant

 not have children

 not have preexisting physical limitations or recent injuries

 not have major cognitive impairments (i.e., assessed by whether they can understand and respond adequately to all screening questions)

['Exercise info', 'Implementation intentions', 'Industriousness', 'pedometer']

Exercise info
Implementation intentions
Industriousness
pedometer


Diagnosing Pulmonary Aspergillosis in Patients With Hematological Malignancies: A Multicentre Prospective Evaluation of an Aspergillus PCR Assay and a Galactomannan ELISA in Bronchoalveolar Lavage Samples

Summary: Diagnosing invasive pulmonary aspergillosis (IPA) remains a challenge in patients (pts) with hematological malignancies. The clinical significance of testing bronchoalveolar lavage (BAL) samples both with polymerase chain reaction (PCR) and Aspergillus galactomannan (GM) ELISA is unclear, and the BAL cutoff for GM has not been clearly defined yet. Using a validated nested PCR assay and a GM ELISA, we prospectively examine BAL samples from hematological patients at high risk of PA.
Inclusion criteria: inclusion criteria:

 - hematological patients with lung infiltrates at high risk for invasive aspergillosis

Exclusion criteria: :

 - patients without informed consent


The Use of Modified ride-on Cars to Advance Mobility and Socialization in Young Children With Disabilities

Summary: The four purposes of this study are: 1) to examine the feasibility of providing children with disabilities to explore the environment with a modified ride-on car; 2) to quantify whether children with disabilities are able to have more social interactions with a ride-on car; 3) to examine the progression of socialization during the intervention and follow-up phases to determine which factors might influence the learning curve; 4) to compare the effectiveness of using the modified toy cars through the hospital-based program and regular therapy program after intervention and follow-up phases to determine the critical factors on increasing independent mobility and socialization, including motivation, treatment executor, treatment environment and play programs. It can provide guidelines for the future intervention.~Independent mobility is believed to be essential for perceptual-motor, cognition, language and social skill development. It is important to increase the independent mobility in children with disabilities and further enhance their development, especially motor and socialization. Assistive and power mobility devices allow children with disabilities to move independently within their environment and may increase the opportunities to explore and interact with people and environment . However, issues to consider before prescribing an assistive device include factors such as age, accessibly to community environments, cost, social acceptance of the device and the adaptability of the device to growth. This study is to use the customized, modified ride-on toy cars, to enhance the independent mobility, exploration and socialization through low-cost, family-centered approach. It will also improve family's understanding of children's capabilities, which improve their development. Investigators will recruit 60 children with who are between 1 to 3 years old and diagnosed as motor delay (>1.5 sd). They will be randomly assigned to one of the following two groups: hospital-based program group and regular therapy group.~The whole study duration will be 18 weeks, including 9-week intervention and 9-week follow-up; the total amount of treatment will be equal for two groups. The hospital-based program will be administered by the therapist and include 120 minutes/per session, 2 sessions/per week. In addition, the research team will visit the hospital once/per week to provide assessments. The regular therapy group will continue their regular therapy without any additional car driving training. The research team will visit them once/per week for the assessments. The assessments include behavior coding from the videotapes and the clinical assessments. The findings of this study will help to understand the feasibility and effectiveness of using the low-tech modified toy cars on advancing children's mobility and socialization. They can be used in the clinics and are a low cost alternative or addition to other mobility devices. They may provide a novel therapeutic tool to improve mobility, socialization and development.
Inclusion criteria: inclusion criteria:

 motor delays (sd>1.5) resulting in motor impairments that prevented functional independent mobility, such as rolling, crawling, walking;

 aged between 12 months to 36 months old;

 able to tolerate sitting with support for 30 minutes;

 able to reach the objects with either one or two hands;

 consent of the parents to agree to the testing procedures and participate in the training program at their own house or at the hospital.

Exclusion criteria: :

 children with severe sensory impairments such as blindness, deafness,

 parents/caregivers are not able to make a time commitment for the training phase.

['Hospital-based Program', 'Regular Therapy Program']

Hospital-based Program
Regular Therapy Program


Trial Comparing Single Versus Double Incision to Repair Distal Bicep Tendon Ruptures

Summary: The purpose of this study to to determine whether a single incision technique or a double incision technique is more effective in the surgical treatment of distal bicep tendon ruptures. Patients will be randomized to one of the two techniques upon consenting to the study. Prior to surgery patients will have their elbow flexion, extension, pronation, and supination strength measured. Elbow Range of motion will also be measured in each of these four movements. A number of subjective questionnaires will also be administered to the patient prior to surgery. The identical objective tests and subjective questionnaires will be completed by the patient at intervals of three months, six months, one year, and two years following their surgery. Additional information from patients clinical visits may also be collected throughout the study.
Inclusion criteria: inclusion criteria:

 Complete rupture of the Distal Bicep tendon

 Acute bicep tendon rupture (< 10 days since rupture)

 18 years of age and older

Exclusion criteria: :

 Partial rupture of the Distal Bicep tendon

 Chronic bicep tendon Ruptures (>10 days since rupture)

 Under 18 years of age


Use of Amplified Sound Signal to Identify Presence of Carotid and Femoral Stenosis

Summary: The purpose of the study is to test a new amplified stethoscope(AudioDoc) that can detect the presence of bruit by using an acoustic signal to represent the bruit. This pilot study will address two questions: is there a detectable difference in recorded sound signal of carotid and femoral bruit when compared to sound signals captured when there is no bruit present; is the use of a visual recorded signal more accurate in identifying carotid and femoral bruit when compared to traditional auscultation with a regular stethoscope and ultrasound.
Inclusion criteria: inclusion criteria:

 age 19-90 years

 having clinical ultrasound evaluation of carotid or femoral artery

Exclusion criteria: :

 under age 19; over age 90 years

['Carotid Stenosis', 'Femoral Arterial Stenosis', 'Carotid Bruit Asymptomatic', 'Carotid Murmur']

Carotid Stenosis
Femoral Arterial Stenosis
Carotid Bruit Asymptomatic
Carotid Murmur


Effects of Inhaled Corticosteroids in the Systemic Inflammation Induced by Exercise in Patients With COPD

Summary: Chronic obstructive pulmonary disease (COPD) is characterized by pulmonary and systemic inflammation. The effect of inhaled corticosteroids (IC) on inflammation in COPD is controversial.
Inclusion criteria: inclusion criteria:

 ex-smokers (> 10 packets-year) with moderate-severe COPD patients
Exclusion criteria:

['Chronic Obstructive Pulmonary Disease']


Comparative Analysis of Injectable Anticoagulants for Thromboprophylaxis Post Cancer-related Surgery

Summary: Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common post-operative complication. The effectiveness of fondaparinux compared with other injectable anticoagulants in VTE following major orthopedic and abdominal surgery has been evaluated in database studies; however, the effectiveness of injectable anticoagulant medications following cancer-related surgeries in the practice setting has not been as well documented.~The objective of this study is to analyze patient records from a national hospital database and compare the outcomes and costs between four types of injectable anticoagulant medications that were prescribed for the prevention of VTE following cancer-related surgery. This analysis will assess and quantify the outcomes, resource utilization, and cost of care for patients receiving fondaparinux, enoxaparin, dalteparin or unfractionated heparin. The outcomes of interest include the occurence of VTE, rates of major bleeds, medical resource utilization, and total costs (medical plus pharmacy).~The source of data for this study is the Premier Perspective Database™. This hospital claims database links de-identified inpatient medical, pharmacy, and billing data from more than 500 hospitals.~This study is a retrospective cohort study that uses propensity score matching to adjust for the differences between the numbers of patients treated with each medication.
Inclusion criteria: inclusion criteria:

 age 18 and older

 at least one record of a primary inpatient discharge diagnosis of cancer (index hospitalization)

 a procedure code for a cancer-related surgery during the index hospitalization

 a code for an anticoagulant treatment (dalteparin, enoxaparin, fondaparinux or unfractionated heparin (UFH)) as thromboprophylaxis therapy during the day prior to or two days after cancer-related surgery during the index hospitalization (this is the INDEX EVENT)

Exclusion criteria: :

 a record that the patient received more than one injectable anticoagulant on Day 1 of anticoagulant therapy

 a record that the patient received anticoagulant therapy prior to index anticoagulant

 a primary diagnosis code of DVT, PE, or major bleed

 evidence of an outpatient emergency department or hospital outpatient clinic visit that included a diagnosis code for DVT or PE during the 6 months prior to the index hospitalization

 patient records for patients transferred from another facility outside Premier system on index hospitalization

['dalteparin', 'enoxaparin', 'fondaparinux', 'unfractionated heparin']

dalteparin
enoxaparin
fondaparinux
unfractionated heparin


Efficacy and Effectiveness of Combined Therapy for Uncomplicated Malaria Treatment in Peru

Summary: This is a study of the efficacy and effectiveness of combination therapy for malaria due to P. falciparum in the Loreto Department, Iquitos, Peru. The investigators will enroll subjects ≥ 1 year-old who have a diagnosis of uncomplicated malaria due to P. falciparum. Patients will receive a treatment regimen consisting of mefloquine (25 mg/kg per day for two days) and artesunate (12 mg/kg per day for three days). Patients will be divided into two groups: one will receive drugs under direct supervision and the other will be instructed on how to take the drugs by themselves. Clinical and parasitologic response will be monitored for a follow-up period of 28 days. The findings of this study will be used to guide the Ministry of Health in evaluating its national policy for P. falciparum malaria treatment.
Inclusion criteria: inclusion criteria:

 Age > 1 year

 Axillary temperature ≥ 37.5ºC and/or history of fever in the previous 48 hours without any other evident cause

 Unmixed infection with P. falciparum of between 250 and 100,000 asexual parasites/mm3 as determined by microscopic exam of the thick or thin smear

 An informed consent obtained from the patient or his/her guardian (in case of patients ≤ 18 years old) and assent for children (8-18 years old)

 Willingness to come to the health facility for the following 28 days

Exclusion criteria: :

 Signs or symptoms of severe malaria

 Other severe chronic diseases (e.g., cardiologic, renal, or hepatic diseases; HIV/AIDS; severe malnutrition)

 History of allergy to any of the proposed treatment or its alternatives, i.e. mefloquine, artesunate, quinine, tetracycline, or clindamycin

 Pregnancy (based on urine test), since this group of patients receives other drugs for malaria treatment in accordance with Peruvian national guidelines.


Control of Pregnancy Associated Malaria With Intermittent Preventive Treatment

Summary: Malaria is one of the major causes of illness and mortality in Sub-Saharan Africa. In Ghana, malaria is the most important cause of morbidity and accounts for about 40% of outpatient contacts. Chemoprophylaxis and insecticide-impregnated bed nets are used for malaria control in pregnancy.Chloroquine is administered within the ANC package at health facilities in Ghana. However, many pregnant women in rural,low-income communities do not report for ANC or report late thereby increasing their risk of morbidity and mortality. Reasons for this include inaccessibility and high cost. As the gap between urban and rural health care and socioeconomic circumstances increase, malaria control remains the major challenge of the health sector. A facility-based intervention alone is not sufficient to have a significant or sustained impact on malaria control in pregnancy. Alternative strategies are needed for the delivery of malaria interventions to pregnant women in rural areas in Ghana. The overall objective of this study is to develop alternative strategies for community involvement for delivery of malaria interventions to pregnant women in rural Ghana. The project will be conducted in the Afigya Sekyere district in the Ashanti Region of Ghana. Interviews and focus group discussions will be conducted with pregnant women and community members focusing on local knowledge on control of malaria in pregnancy and factors influencing utilization of antenatal services. Women in their first and second pregnancies who are permanently resident in the study area will be included in the study using IPT with sulphadoxine-pyrimethamine (SP). The study population will be randomized to:Group 1 will receive clinic-supervised IPT-SP and daily folate/iron supplementation and Group 2 will access IPT-SP with daily folate/iron supplementation from trained traditional birth attendants (TBA). Midwives and TBAs will be trained in preparing thick blood smears and placenta biopsies for parasitological examination. Parasitaemia and Hb will be measured at entry and at delivery and fever episodes during pregnancy will be recorded. Study participants will be followed for adverse reactions within a week after drug administration. The effectiveness of community-based IPT for the control of malaria in pregnancy will be determined. The endpoints of the study will be birth weight, maternal anaemia, fever episodes and prevalence of peripheral and placental parasitaemia in the groups.
Inclusion criteria: inclusion criteria:

 Primigravida

 Secundigravida

 Permanent resident

 Hemoglobin (Hb) > 7 g/dl

Exclusion criteria: :

 Hb < 7 g/dl

 Allergy to sulpha

 Multiple pregnancy

 Chronic diseases


The Circadian Rhythm of Urine Output in Healthy Infants

Summary: The purpose of this study is to describe the 24-hour urine output including the urinary excretion of hormones, electrolytes and other osmotically active substances in healthy children age 0 to 3 years old.
Inclusion criteria: inclusion criteria:

 Healthy children, free of medication

Exclusion criteria: :

 History of urinary diseases


Reducing Suicidal Ideation Through Insomnia Treatment

Summary: Epidemiologic reports have linked insomnia to suicidal ideation and suicide death. However, no studies have determined whether treating insomnia decreases the risk of suicidality. We have new data indicating that (1) the link between insomnia and suicidal ideation holds true in clinical trials of depressed insomniacs, (2) dysfunctional cognitions about sleep are related to suicidal ideas, and (3) treatment of insomnia with hypnotics leads to a reduction of suicidal ideation. We now propose to test whether cautious use of hypnotics in suicidal, depressed insomniacs may reduce suicide risk in a multi-site clinical trial.
Inclusion criteria: inclusion criteria:

 Persons 18-65 years of age

 Persons with confirmed DSM-IV diagnosis of MDE by SCID

 Persons with Research Diagnostic Criteria diagnosis of insomnia

 Persons free of all psychotropic medications for one week before baseline assessment, except that prior FLX treatment will require 4 weeks of abstinence, and MAOIs will require 2 weeks of abstinence.

 Persons with Scale for Suicide Ideation (SSI) scores >2

 Persons with Hamilton Rating Scale for Depression (HRSD24) score >20

 Persons with Mini Mental State Exam (MMSE) score >24

 Persons with Insomnia Severity Index (ISI) score > 7

 Persons with habitual sleep latency > or = 30 minutes or wake time in the middle of the night of > or = 30 minutes, and sleep efficiency < 85%

Exclusion criteria: :

 Non-English speaking, reading, writing persons

 Persons who pose imminent danger to self or others

 Persons with severe suicidal ideation (C-SSRS Suicidal Ideation Score >3)

 Persons with clinical diagnosis of dementia

 Persons with active or past diagnosis of alcohol or substance abuse, bipolar disorder, schizophrenia per the SCID

 Persons who screen positive for moderate-severe sleep apnea (AHI >10) or a prior sleep laboratory-confirmed diagnosis of a primary sleep disorder, such as sleep apnea or periodic limb movement disorder.

 Persons with BMI > 50

 Persons with a self-reported history of napping > 2 times per week (as these are associated with sleep apnea and periodic limb movement disorder in depressed insomniacs)

 Persons who might be harmed by exposure to hypnotics, including pregnant women and patients with respiratory conditions

['Insomnia', 'Depression', 'Suicidal Ideation']


Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Bone Marrow Transplant Recipients (ACE-BMT)

Summary: CMV is one of the most important opportunistic infection in transplant recipients. In South Korea, more than 95% of adults reveal sero-positivity for CMV IgG. Until now, sero-positivity for CMV IgG before bone marrow organ transplantation is a laboratory test of choice to stratify the risk of CMV reactivation after solid organ transplantation. Theoretically, CMV-specific cell-mediate immune response before and after bone marrow transplantation will further categorize the patients into high or low risk of CMV development after bone marrow transplantation. The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in bone marrow transplant candidates to predict the development of CMV infection after transplantation.
Inclusion criteria: inclusion criteria:

 age 16 or more

 agree with written informed consent

Exclusion criteria: :

 no


Glembatumumab Vedotin in Treating Patients With Recurrent or Refractory Osteosarcoma

Summary: This phase II trial studies how well glembatumumab vedotin works in treating patients with osteosarcoma that has come back (recurrent) or does not respond to treatment (refractory). Monoclonal antibodies, such as glembatumumab vedotin, may find tumor cells and help kill them.
Inclusion criteria: inclusion criteria:

 Patients must have had histologic verification of osteosarcoma at original diagnosis or relapse

 Patients must have measurable disease according to RECIST 1.1, and have relapsed or become refractory to conventional therapy

 Patient must have archival tumor specimen available for submission

 Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age

 Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study

 Myelosuppressive chemotherapy: must not have received within 2 weeks of entry onto this study (4 weeks if prior nitrosourea)

 Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent

 Radiation therapy (RT): >= 2 weeks for local palliative RT (small port); >= 6 months must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 weeks must have elapsed if other substantial bone marrow (BM) radiation

 Monoclonal antibodies: must not have received any monoclonal based therapies within 4 weeks, and all other immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) within 2 weeks, prior to study enrollment

 Peripheral absolute neutrophil count (ANC) >= 1000/uL

 Platelet count >= 75,000/uL (transfusion independent)

 Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions)

 Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:

 Age 1 to < 2 years (male and female: 0.6 mg/dL)

 Age 2 to < 6 years (male and female: 0.8 mg/dL)

 Age 6 to < 10 years (male and female: 1 mg/dL)

 Age 10 to < 13 years (male and female: 1.2 mg/dL)

 Age 13 to < 16 years (male: 1.5 mg/dL and female: 1.4 mg/dL)

 Age >= 16 (male: 1.7 mg/dL and female: 1.4 mg/dL)

 Total bilirubin =< 1.5 x upper limit of normal (ULN) for age

 Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 110 U/L; for the purposes of this study the ULN for SGPT is defined as 45 U/L

 Serum albumin > 2 g/dL

 Shortening fraction of >= 27% by echocardiogram, or

 Ejection fraction of >= 50% by radionuclide angiogram

 All patients and/or their parents or legal guardians must sign a written informed consent

 All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion criteria: :

 Patients with > grade 2 neuropathy according to the Modified (Balis) Pediatric Scale of Peripheral Neuropathies will be excluded except in cases in which neuropathy is secondary to prior surgery

 Patients who have previously received CDX-011 (CR011-vc monomethyl auristatin E [MMAE]; CDX-011) or other MMAE-containing agents

 Patients who have received other investigational drugs within 2 weeks or 5 half-lives (whichever is longer) prior to study enrollment

 Patients with a history of allergic reactions attributed to compounds of similar composition to dolastatin or auristatin; compounds of similar composition include auristatin PHE as an anti-fungal agent, auristatin PE (TZT-1027, Soblidotin, NSC-654663) as an anti-tumor agent and symplostatin 1 as an anti-tumor agent

 Patients with known central nervous system metastasis are not eligible

 Patients who have had major surgery within 2 weeks prior to enrollment are not eligible; procedures such as placement of a central vascular catheter, or limited tumor biopsy, are not considered major surgery

 Female patients who are pregnant are ineligible

 Lactating females are not eligible unless they have agreed not to breastfeed their infants

 Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained

 Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation and for 2 months after the end of study treatment

['Glembatumumab Vedotin', 'Laboratory Biomarker Analysis', 'Pharmacological Study']

Glembatumumab Vedotin
Laboratory Biomarker Analysis
Pharmacological Study


A Randomized Controlled Trial of Oral Naproxen and Transdermal Estradiol for Bleeding in LNG-IUC

Summary: We hypothesize that the addition of oral naproxen or transdermal estradiol will decrease the number of days of unscheduled bleeding experienced by first-time users of the levonorgestrel intrauterine system (LNG-IUC) during the first 12 weeks of use compared to an oral placebo. The objective of this study is to compare the total number of days of bleeding experienced by first time users of the LNG-IUC randomized to oral naproxen or estradiol patch compared to those randomized to placebo for the first 12 weeks of use. We will enroll women initiating LNG-IUC to one of 3 groups, transdermal estrogen, oral naproxen or oral placebo. We will enroll a total of 114 women, 38 in each group. Women will keep bleeding diaries for 16 weeks which will be used to calculate the total number of bleeding or spotting days. Statistical analysis will be performed to evaluate if there is less bleeding among the treatment arms then the placebo arm.
Inclusion criteria: inclusion criteria:

 Must be of reproductive age from 18 to 45 years

 Must be choosing LNG-IUC for contraception

 Must be English-speaking

 Be willing to avoid additional use of exogenous hormones, such as oral contraceptives, for the duration of the study

 Be willing to avoid additional use of nonsteroidal antiinflammatory drugs, such as ibuprofen or aspirin for the duration of the study

 Be willing to comply with the study protocol, keep the bleeding diary and comply with follow-up visits and telephone interviews as scheduled

 Be willing and able to provide informed consent

Exclusion criteria: :

 Known or suspected pregnancy

 Contraindication to estrogen use, such as presence or history of:

 venous thromboembolism

 Arterial thrombosis

 Thrombophilia disorders, or known family history of

 Hypertension

 Migraine headaches with aura or focal neurologic involvement, or any migraine over age 35 years

 Recent or planned future major surgery which will result in prolonged immobilization during the study period

 Presence or history of severe hepatic disease or liver tumors

 Known or suspected estrogen-dependent neoplasm

 Vaginal bleeding of unknown etiology

 Any cigarette smoking and age over 35 years

 Contraindications to nonsteroidal anti-inflammatory use, such as presence or history of:

 Gastrointestinal ulcer disease

 Renal insufficiency or failure

 Aspirin-induced asthma or hypersensitivity reaction

 Systemic lupus erythematosus (SLE) and mixed connective tissue disorders

 Use of anticoagulants

 Cardiovascular disease

 Use of medications that alter estrogen metabolism, i.e. rifampin, certain anti-seizure medications

 Regular use of an NSAID

 Current diagnosis of menorrhagia, metrorrhagia, symptomatic uterine fibroids, or endometrial polyp

 Hypersensitivity or allergy to any of the components of the estradiol patch

 Use of injectable contraception within 6 months of the start of the study medication

 Delivery or abortion in the previous 4 weeks

 Prior use of LNG-IUD

 Any condition, that in the opinion of the investigator, would contraindicate study participation

['transdermal estradiol', 'naproxen', 'oral placebo']

transdermal estradiol
naproxen
oral placebo


Maternal Hypothyroidism in Pregnancy

Summary: There is general agreement that thyroid gland function should be assessed in pregnant women. When the gland produces too little thyroid hormone (hypothyroidism), all of the woman's bodily functions slow down, and there are problems with her baby's development. Until now, physicians have identified this problem on an individual basis (case-finding), but this approach misses many of the cases. Our trial aims to replace case-finding with a routine blood test that is highly effective at detecting hypothyroidism, thereby allowing treatment to correct the deficiency. This approach can eventually be implemented throughout the United States.
Inclusion criteria: inclusion criteria:

 TSH value >98th centile in early pregnancy

Exclusion criteria: :

 Women with known hypothyroidism


Tailored Activity Program-Veterans Affairs

Summary: The Tailored Activity Program - Veterans Administration is a Phase III efficacy trial designed to reduce behavioral symptoms in Veterans with dementia living with their caregivers in the community. The study uses a randomized two group parallel design with 160 diverse Veterans and caregivers. The experimental group receives a transformative patient-centric intervention designed to reduce the burden of behavioral symptoms in Veterans with dementia. An occupational therapist conducts an assessment to identify a Veteran's preserved capabilities, deficit areas, previous roles, habits, and interests to develop activities tailored to the Veteran. Family caregivers are then trained to incorporate activities into daily care. The attention-control group receives bi-monthly telephone contact where education on topics relevant to dementia is provided to caregivers. Key outcomes include reduced frequency and severity of behavioral symptoms using the 12-item Neuropsychiatric Inventory (primary endpoint), reduced caregiver burden, enhanced skill acquisition, efficacy using activities, and time spent providing care at 4 months; and long-term effects (8 months) on the Veteran's quality of life and frequency and severity of behavioral symptoms, and caregiver use of activities. The programs' impact of Veterans Administration cost is also examined. Study precision will be increased through face-to-face research team trainings with procedural manuals and review of audio-taped interviews and intervention sessions.
Inclusion criteria: inclusion criteria:

 inclusion criteria for Veterans with dementia include:

 English speaking

 diagnosed with dementia as above

 able to participate in at least two activities of daily living

 ADLs - bathing

 dressing

 grooming

 toileting

 transferring from bed to chair

 not currently participating in any other dementia-related intervention.

 If the Veteran with dementia is on any of four classes of psychotropic medications:

 antidepressant

 benzodiazepines

 antipsychotic

 anti-convulsant

 an anti-dementia medication (memantine or a cholinesterase inhibitor)

 We will require that he/she have been on a stable dose for 60 days prior to enrollment to minimize possible confounding effects of concomitant medications (the typical time frame used in clinical trials).

 Caregivers of Veterans must be:

 English speaking

 self-identify as the primary member of the family caring (hands-on or supervision) for the Veteran and 21 years of age or older (male or female)

 living with the Veteran

 accessible by telephone to schedule interview, intervention sessions and follow-up interviews

 planning to live in area for 8 months (to reduce loss to follow-up)

 indicate willingness to learn activity use

 report one or more NPS in the Veteran in the past month

 not currently participating in any other caregiver-related intervention.

 Finally, we will require that caregivers taking a psychotropic medication (antidepressant, benzodiazepines, antipsychotic, or anti-convulsant) at time of telephone screen be on a stable dose of the medication for 60 days prior to enrollment.

Exclusion criteria: :

 Non English speaking

 Non-Veteran

 No caregiver

 No diagnosis of dementia

['Tailored Activity Program', 'Attention Control']

Tailored Activity Program
Attention Control


The Using of NEurocryostimulation in Military Ankle Sprains

Summary: Introduction: The military population is at high-risk for injury with by painful sprains, especially of the ankle. The referenced treatment method for pain is the cryotherapy, consisting in applying cold-packs to the injured ankle several times a day. However, another pain treatment has been developed and is commonly used by high-level sports teams and rheumatologists but its efficacy has never been assessed within a military population, i.e. the hyperbaric CO2 cryotherapy, also called the neurocryostimulation.~Research design: This study was carried out on a French multicenter basis, the study consisting in a randomized controlled superiority trial and open-label prospective analysis in the treatment of 40-year-old military patients or younger suffering from acute ankle sprains. Two groups were made: patients were treated either by neurocryostimulation or by the referenced cryotherapy (cold-packs). The care protocol for both groups consisted in six supervised 30 minute-sessions within a period of three consecutive days.~Hypothesis: Neurocryostimulation is more effective in the treatment of pain severity resulting from an ankle sprain than the referenced treatment by cold-packs. Moreover, we theorized that the total consumption of paracetamol and the number of days of temporary inaptitude and of work exemption were lower in patients treated by neurocryostimulation.~Outcomes:~For each session, pain severity is assessed on a 100-mm Visual Analog Scale at the beginning and at the end of session 20 minutes later after a four-step walk.
Inclusion criteria: inclusion criteria:

 age equal or less than 40 years-old, military subject, acute ankle injury, To have completed and signed the informed consent.

Exclusion criteria: :

 contraindications to cryotherapy ( cold allergy, cryoglobulinemia, Raynaud's phenomenon, cutaneous sensory abnormalities, and diabetes mellitus), paracetamol allergy, 4th grade sprains according to the Trevino Classification (with bone wrenching), to take analgesic or anti-inflammatory treatment other than paracetamol.

['neurocryostimulation with Duo-cryo® device', 'cryotherapy with Cold pack® or ice-cubes pack']

['Sprain of Lateral Ligament of Ankle Joint']


Enhancement of in-Vitro GC Function in Patients With COPD

Summary: The investigator wish therefore to continue these studies on theophylline principally by conducting a small clinical pilot study on 20-30 COPD patients in a randomised, double-blind, placebo-controlled, parallel-group study.
Inclusion criteria: inclusion criteria:Participants with COPD with an FEV1 of 80-30% predicted. This will incorporate the majority of participants with COPD seen within the chest clinic. Patients with an FEV1 > 80% predicted are not generally severe enough to warrant hospital follow up. These patients are also unlikely to have severe enough disease (and therefore airway inflammation) which may be modified by the therapeutic agents we are studying.

 Patients with an FEV1 < 30% tend to have more severe symptom limitation and generally (though not always) find participation in a clinical trial involving 4 visits to the clinic difficult. Their airway disease is also generally less responsive to therapeutic intervention and as a consequence finding measurements which show changes to these therapeutic interventions is more difficult.

 COPD patients

 All participants will be classified to Stage 2-3 of the GOLD (Global initiative for Obstructive Lung Disease) guidelines

 Male or female, aged 45-80 years (according to GOLD guidelines)

 30% < FEV1 < 80% predicted

 FEV1/FVC < 70%

 Cigarette exposure of >10 pack-years#

 With or without chronic symptoms (cough, sputum production, dyspnea).

 Steroid therapy will be stopped before run-in, but long acting bronchodilators are acceptable.

 The participants are able to give informed consent # The smoking history should include both the number smoked, for how long, and an estimate of total pack-years of smoking. One pack of 20 cigarettes smoked per day for 1 year = one pack year. Total pack years = No. cigarettes smoked per day/20 x no. years of smoking

Exclusion criteria: :

 Any history or evidence of asthma

 Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator

 Hospital admission with respiratory infection within the last 6 months

 Upper respiratory infection within the last 4 weeks

 Participants who have received research medication within the previous one month

 Participants unable to give informed consent

 Any mental condition rendering the participant unable to understand the nature, scope and possible consequences of the study

 Known or suspected hypersensitivity to study therapy or excipients

 Participants with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator

 Any current respiratory tract disorders other than COPD, which is considered by the investigator to be clinically significant

 Any significant disease or disorder (e.g. gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) or abnormality laboratory tests which, in the opinion of the investigator, may either put the participant at risk because of inclusion in the study, or may influence the results of the study, or the participants ability to take part in the study

['Fluticasone Propionate', 'placebo', 'Theophylline']

Fluticasone Propionate
placebo
Theophylline


The Role of Angiotensin Type I Receptor in the Regulation of Human Peripheral Vascular Function

Summary: The renin angiotensin system (RAS) plays an important physiological and pathophysiological role in the control of blood pressure and plasma volume. Inhibition of the RAS is useful in the treatment of hypertension, cardiac failure and in some patients with myocardial infarction. Several recent clinical trials with angiotensin converting enzyme inhibitors (ACEI) have shown that they also reduce the incidence of myocardial infarction, but the mechanisms underlying this anti-ischemic effect are poorly understood. ACEI reduce angiotensin II synthesis and prevent bradykinin degradation. Results from ongoing studies in the Cardiology Branch (Protocol 95-H-0099) designed to investigate the link between ACEI and the vascular endothelium indicate that ACEI improve peripheral endothelial function, an effect that is partially mediated by bradykinin. The current protocol is designed to investigate whether the beneficial effects of ACEI on peripheral endothelial function are also due to inhibition of angiotensin II. The recent development of selective angiotensin II type 1 (AT1) receptor antagonists allows us to specifically examine the effects of angiotensin II on vasomotor activity.
Inclusion criteria: Patients over 18 years with endothelial dysfunction requiring diagnostic cardiac catheterization.

 Normal volunteers or patients undergoing catheterization who have normal coronary arteries without risk factors for atherosclerosis will be used as controls.

 No unstable angina.

 No significant left main disease (greater than 50% stenosis).

 No recent myocardial infarction (less than 1 month).

 No pregnancy, lactation.

 No allergy to losartan.

 No renal failure (creatinine greater than 2.5 mg/dl).

 Ability to withdraw ACE inhibitors.
Exclusion criteria:

['Angiotensin II type 1 receptor antagonists']

['Atherosclerosis', 'Heart Failure, Congestive', 'Hypertension', 'Myocardial Infarction']

Atherosclerosis
Heart Failure
Congestive
Hypertension
Myocardial Infarction


Use of Nesiritide in the Management of Acute Diastolic Heart Failure

Summary: Primary objective is to assess the effect of nesiritide in decreasing left ventricular (LV) filling pressure, defined as pulmonary artery capillary wedge pressure (PCWP) in a group of patients admitted with acute diastolic heart failure.~Secondary objectives include: improvement in symptoms, exercise tolerance, improvement in Doppler diastolic filling parameters in patients with diastolic heart failure.
Inclusion criteria: The patient population recruited for this study will include patients being admitted for acute congestive heart failure. Eligible patients include those who have near normal LV systolic function.

 inclusion criteria:

 Age 18 to 85 years old

 Admitted with acute heart failure determined by: symptoms of fatigue; shortness of breath; edema; physical evidence of volume overload; and/or pulmonary edema by CXR

 LVEF > or = 40% on recent (< or = 1 month) echo or MUGA

 NYHA class III or IV on admission

 Baseline systolic blood pressure > 90 mm Hg

 Baseline BNP level > 100 pg/ml

 Able to sign informed consent and return for follow-up assessments

Exclusion criteria: :

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

 Active infection/sepsis as defined by fever > 101.5 F, currently on IV antibiotics

 Creatinine greater than 3.0 mg/dl

 LV ejection fraction < 40% (must be done within the last 30 days prior to signing consent)

 Significant valvular disease or constrictive cardiomyopathy

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

 Hypersensitivity to nesiritide or any of its components.

 Pulmonary capillary wedge pressure (PCWP) <16 mmHg

 If patient is of child-bearing age, a pregnancy test will be performed, and the patient is excluded if pregnancy test is positive.

['Heart Failure', 'Cardiovascular Disease', 'Acute Heart Failure', 'Diastolic Heart Failure', 'Congestive Heart Failure', 'Heart Disease']

Heart Failure
Cardiovascular Disease
Acute Heart Failure
Diastolic Heart Failure
Congestive Heart Failure
Heart Disease


Oral Versus IV Proton Pump Inhibitor in High-risk Bleeding Peptic Ulcers After Endoscopic Hemostasis

Summary: Endoscopic hemostasis has been documented by a number of clinical studies to be effective in decreasing rebleeding, need for emergency surgery, and hospitalization days. Studies showed adjuvant treatment with proton pump inhibitor (PPI) after initial endoscopic hemostasis reduced recurrent ulcer bleeding. However, the optimal dose and route of adjuvant PPI therapy remains controversial. A recent study demonstrated frequent oral PPI offered similar acid control as currently recommended intravenous infusion PPI did in patients with bleeding ulcers. The investigators hypothesize that an frequent oral PPI treatment has similar benefit as proton pump inhibitor infusion in patient with bleeding ulcers after combined endoscopic hemostasis.
Inclusion criteria: inclusion criteria:

 Age ≥ 18

 Confirmed ulcer bleeding with Forrest Ia, Ib, IIa

 Endoscopic hemostasis achieved by combined endoscopic hemostasis

 Informed consent obtained

Exclusion criteria: :

 No consent

 Unsuccessful endoscopic treatment

 Upper GI malignancy

 History of subtotal gastrectomy

 Bleeding tendency, platelet count < 80x109/L, prothrombin time INR >1.5

 Myocardial infarction or cerebrovascular accident within one week

 Ulcer bleeding because of mechanical factors (such as, induction of NG tube)

 Malignancy or other advanced disease with a life expectancy of < 6 months

 IV PPI > 40mg within 24hrs before enrollment

 Decompensated liver cirrhosis

 Requiring dialysis

 Pregnant or lactating women

 History of allergy or severe side effects to lansoparzole or pantoprazole

['Pantoprazole (Pantoloc)', 'Lansoprazole (Takepron OD)']

Pantoprazole (Pantoloc)
Lansoprazole (Takepron OD)


Inhibition of Complement Activation (Eculizumab) in Guillain-Barre Syndrome Study

Summary: Guillian-Barre Syndrome (GBS) is the most frequent cause of acute neuromuscular weakness in the Western World and can occur at any age. GBS is a rpadily progressive 'inflammatory' disorder of the perihperal nerves often leading to sever paresis of the limbs. Most GBS patients also have sensory disturbances (tingling or dull feeling) and pain. Some patients also have double vision or problems with swallowing. GBS mau also involve the respiratory muscles, leading to insufficient ventilation and admission to an intensive care unit. GBS pateints have a vairable prognosis; 20-30% require mechnical ventilation for a period ranging from weeks to months, 20% are unable to walk after 6 months nad 3-5% dies. Progression of weakness in GBS is usually rapid and reaches its peak within 4 weeks in the majority of patients, but many develop their maximum deficit within 2 weeks. Thereafter, the patients have a variable prognosis.~GBS is a treatable disorder. Intravenous immunoglobulin (IVIg) 2g/kg administered in 5 days was shown to be effective when administered within the first two weeks after onset of symptoms, and is considered the treatment of choice by most experts in the field. Although the standard treatment for GBS is a single course of IVIg (2g/kg administered in 5 days), many patients fails to recover abd remain with substantial disability. Patients with GBS and especially those with a poor prognosis potentially may benefit from more powerful abd when possible a more mechanistically rational therapy.~Recent experimental evidence suggests that complement activation palys a crucial role in the development of neuromuscular weakness in GBS making complement inhibitors and regulators attracive therapeutic targets. Our hypothesis is that Eculizumab, with its function as a complement inhibitor, will be very effective in preventing progression of weakness in patients with GBS.
Inclusion criteria: inclusion criteria:

 Patients aged >18 years diagnosed with GBS according to NINDS diagnostic criteria

 Onset of weakness due to GBS is less than 2 weeks ago

 Patients who are unable to walk unaided for >10 metres (grade >3 on GBS disability scale)

 Patients who are being considered for or already on IVIg treatment

 First dose of eculizumab must be started within 2 weeks from onset of weakness and any time during the IVIg treatment period

 Signed informed consent

Exclusion criteria: :

 Age <18 years

 Patients who are being considered for, or already on, plasma exchange

 Pregnancy or lactation

 Patients show clear clinical evidence of a polyneuropahty caused by e.g. diabetes mellitus (except mild sensory), alcoholism, severe vitamin deficiency, and porphyria

 Patients received immunosuppressive treatment (e.g. azathioprine, cyclosporine, mycofenolatemofetil, tacrolimus, sirolimus or > 20 mg prednisolone daily) during the last month

 Patients known to have severe concurrent disease, like malignancy, severe cardiovascular disease, AIDS, severe COPD, TB

 Inability to comply with study related procedures or appointments during 6 months

 Any condition that in the opinion of the investigator could increase the patient's risk by participating in the study or confound the outcome of the study

 Related to the administration of eculizumab:

 Unresoled Neisseria meningitidisinfection of history of meningococcal infection Unsuitable for antibiotic prophylaxis (e.g due to allergy) Known hypersensitivity to eculizumab, murine proteins or to any of the excipients Known or suspected hereditary complement deficiencies Women of child-bearing potential who are unwilling to use effective contraception during treatment and for 5 months after treatment is completed.


Effects of Paliperidone in Posttraumatic Stress Disorder (PTSD)

Summary: Chronic posttraumatic stress disorder (PTSD) is a debilitating disorder and treatment response to pharmacological interventions has been modest for these patients. Chronic elevated anxiety and associated psychophysiological parameters including increased heart rate and alterations in skin conductance are key symptoms of chronic PTSD. Antidepressants, including selective serotonin reuptake inhibitors (SRIs) or norepinephrine-serotonin re-uptake inhibitors are considered treatment of first choice for these patients, however a substantial portion of patients do not respond sufficiently (Zhang and Davidson 2007). Therefore, there is a need to establish novel and effective add-on treatment strategies for these patients. Recently, atypical neuroleptics have received considerable attention since it was shown in multiple controlled and naturalistic trials that these medications are an effective treatment option for patients with PTSD (Davis et al 2006). In chronic PTSD, the psychophysiological responses at baseline and in response to treatment have yet been inadequately studied and may provide novel insight into antidepressant and anxiolytic mechanisms of medications used in the treatment of PTSD. Therefore, in addition to evaluating the antidepressant and anxiolytic effects of paliperidone, a novel atypical neuroleptic, in the treatment of PTSD, we also aim to compare neurophysiological responses at baseline with post-treatment effects in antidepressant-refractory PTSD patients.~Primary Aim 1: Evaluate the anxiolytic and antidepressant effects of paliperidone in patients with PTSD.~Secondary Aim 2: Evaluate the effects of paliperidone on fear conditioned psychophysiological responses (including startle eyeblink, skin conductance, and cardiovascular inter-beat interval) at baseline and after 6 weeks of naturalistic treatment in chronic PTSD patients.
Inclusion criteria: inclusion criteria:

 willingness to participate in a naturalistic treatment study using paliperidone and in two fear conditioning tests, one at baseline and one at the end of the 6 weeks treatment study.

 We will include PTSD subjects on medications (possible medications include antidepressants, benzodiazepines) who have no or only partial treatment response. Paliperidone will be added to the existing treatment regime which will remain unchanged during the study period. PTSD subjects will have a minimum score of 50 on the Clinician-Administered PTSD Scale (CAPS; Blake et al, 1995).

Exclusion criteria: :

 a comorbid diagnosis of bipolar illness, schizophrenia or other psychotic disorders, acute or chronic suicidality, acute or chronic unstable medical conditions (including severely impaired hepatic function as indicated with abnormal PT and PTT, abnormal CBC, and liver enzymes more than 50% above the upper normal range, not well controlled blood pressure)

 current diagnosis of substance abuse or dependence

 unsuccessful treatment history with paliperidone

 known hypersensitivity to paliperidone or any of its inactive ingredients

 administration of any investigational drug up to 90 days before entry into the study

 intake of Class 1A (e.g., quinidine, procainamid) or Class III (e.g., amiodaronme, sotalol) antiarrhythmic medications, antipsychotics, antibiotics (e.g., gatifloxacin, moxifloxacin) (up to 90 days before entry into the study or during the study)

 subjects with a positive screen for drugs of abuse

 no startle or skin conductance response, or excessively high startle response to the startle probe (100 dB acoustic stimuli) during the pretest.


Plasma ExtrAcellular RNAs and Biomarkers of Heart FaiLure During Decongestion: PEARL-HF Study

Summary: The primary objective is to measure the association between extracellular RNA (ex-RNA) levels in plasma in patients receiving aggressive outpatient therapy for CHF with (1) cardiac remodeling and (2) cardiovascular events. The investigators will follow patients during standard medical therapy for CHF to assess changes in ex-RNA levels in the plasma, and how these are associated with cardiac remodeling (by cardiac imaging) and outcomes.
Inclusion criteria: inclusion criteria:

 Age > 21 years of age

 Left ventricular ejection fraction ≤ 50% (at any time in the past)

 Symptomatic (NYHA class II-IV) heart failure (as diagnosed by clinician, radiographic images, or abnormal natriuretic peptide level)

 Hospital admission, Emergency Department visit, or outpatient diuretic escalation of therapy for destabilized HF at least once in the 6 months prior to enrollment

Exclusion criteria: :

 Severe renal insufficiency defined as serum creatinine > 2.5 mg/dl

 United Organ Network Sharing status 1B for heart transplantation (outpatient inotrope use, LV assist device)

 Inoperable aortic valvular heart disease

 Life expectancy <1 year due to causes other than HF such as advanced cancer

 Cardiac transplantation or revascularization indicated or expected within 6 months

 Severe obstructive or restrictive pulmonary disease, defined as a forced expiratory volume in 1 sec <1 L (when diagnosed as standard of care)

 Subject unable or unwilling to provide written informed consent

 Coronary revascularization (percutaneous coronary intervention or bypass surgery) within the previous 3 months


Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablet (ODT) And 10 Mg Amlodipine Besylate Tablets

Summary: This study is being performed to determine the bioavailability, or extent of absorption into the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to the bioavailability of a 10 mg amlodipine besylate (non-ODT) tablet.
Inclusion criteria: inclusion criteria:

 Healthy male and/or female subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

 Body Mass Index (BMI) of 18 to 26 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion criteria: :

 Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

 A positive urine drug screen.

['Amlodipine - reference', 'Amlodipine ODT - test', 'Amlodipine ODT - test']

Amlodipine - reference
Amlodipine ODT - test
Amlodipine ODT - test


Effect of Beetroot Juice on Coronary Blood Flow and Walking Performance in PAD

Summary: In this study the investigators will test the hypothesis that short-term consumption of inorganic nitrate (supplied in concentrated beetroot juice) enhances coronary blood flow responses, large artery hemodynamics, and leg oxygenation/exercise tolerance in patients with peripheral arterial disease (PAD). Understanding and improving blood flow regulation in the heart and skeletal muscles of patients with PAD is important because exercise triggers symptoms of leg pain and substantially raises blood pressure and myocardial demand in these patients.
Inclusion criteria: inclusion criteria:

 Patients with peripheral arterial disease (PAD)

 Capable of giving informed consent

 Men and women age 21- 85 years

 Diagnosed with PAD (i.e., ankle-brachial index below 0.9)

 Fontaine stage II or less - no pain while resting

 Satisfactory history and physical exam

Exclusion criteria: :

 Children

 Pregnant or nursing women

 Patients taking nitroglycerine or nitrate preparations

 Patients taking phosphodiesterase inhibitors such as sildenafil or tadalafil

 Patients taking proton pump inhibitors

 Ejection fraction < 40%

 Uncontrolled hypertension

 Uncontrolled diabetes

 Myocardial infarction within past 6 months or unstable angina

 Severe lung disease (i.e., on supplemental oxygen or frequently use rescue inhalers)

 Abnormality in hemoglobin or hematocrit or methemoglobin

 Impaired renal function

 Impaired liver function

 History or diagnosis of Barrett's esophagus

 Known allergy to beetroot juice or lemon juice

 Inability to walk on a treadmill at a moderate pace (2.0 miles/hour)

['Beetroot juice', 'Beetroot juice placebo']


Comparison of Efficacy and Frequency of Adverse Events of 1st Line Palliative Chemotherapy EOX and mDCF Regimens in Advanced HER2-negative Gastric Carcinoma

Summary: The purpose of the study is to compare efficacy and safety of palliative chemotherapy EOX and mDCF regimens in the first-line treatment of patients with advanced HER2-negative gastric and gastroesophageal junction (GEJ) adenocarcinoma
Inclusion criteria: inclusion criteria:

 Patients ≥ 18 years

 histologically confirmed inoperable locally advanced, recurrent, or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction;

 ECOG (Eastern Cooperative Oncology Group) performance status 0-2;

 adequate renal, hepatic, and hematologic function;

 measurable or nonmeasurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST). Patients with intraoperatively confirmed intraperitoneal metastases but without detectable disease in radiological studies were also eligible

Exclusion criteria: :

 HER2- positive tumors defined as either IHC 3+ or IHC 2+, the latter in combination with FISH+

 previous chemotherapy for metastatic or locally advanced disease

 surgery <3 weeks before the onset of the study treatment

 congestive heart failure

 significant dysphagia that would preclude oral administration of capecitabine

 concurrent malignant disease, except for adequately treated tumors with high likelihood of being cured (e.g. basal cell carcinoma of the skin, cervical cancer)

 clinical evidence of brain metastases


Hypothermia in Traumatic Brain Injury in Children (HiTBIC)

Summary: The purpose of this study is:~To determine the safety and feasibility of performing an international multi-centre randomized control trial of early and prolonged hypothermia to improve outcome in children with severe traumatic brain injury (TBI).~To determine whether in children with severe traumatic brain injury, prolonged initial hypothermia (minimum 72 hours at 32-33 degrees) improves the proportion of good outcomes 12 months after injury when compared to initial normothermia (36-37 degrees).
Inclusion criteria: inclusion criteria:

 have a severe traumatic brain injury as defined by either a GCS ≤ 8 and an abnormal CT scan (intracranial hemorrhage, cerebral edema or diffuse axonal injury) or a motor score ≤ 3 and normal CT scan

 are aged between 1 and 16 years

 are mechanically ventilated

Exclusion criteria: :

 are not randomized by 6 hours after injury

 have penetrating brain injuries

 have fixed dilated pupils and GCS = 3

 have proven cervical spinal cord injury

 have more than mild neurodevelopmental disability prior to injury

 have an acute isolated epidural hematoma and are expected to recover rapidly after surgical removal

 have had a post-traumatic seizure with a normal CT scan

 have refractory shock, defined as systolic blood pressure more than 2 standard deviations (SD) below the mean for age despite 80ml/kg intravenous fluid resuscitation


I-Scan Vs High Definition White Light (Main Study)

Summary: The purpose of this study is to assess whether the use of I-Scan during colonoscopy leads to an increased yield of adenomas in the colon among a population at increased risk for CRC.~Primary Outcome:~Adenoma Detection Rate (ADR - No. of colonoscopies at which one or more histologically confirmed adenomas were found divided by the total no. of colonoscopies performed in the same time period) in the right colon using High Definition White Light Colonoscopy Versus I-Scan enhanced Colonoscopy.~Secondary Outcomes:~Adenoma Detection Rate (ADR) of High Definition White Light Colonoscopy Versus I-Scan colonoscopy through out the entire colon.~Adenoma Detection Rate (ADR) in the right colon during the Second look, irrespective of imaging modality.~Polyp Detection Rate (PDR - No. of colonoscopies at which one or more polyps were found(regardless of the histological type) divided by the total no. of colonoscopies performed in the Same time period) for each arm of the study in Right colon and throughout the entire colon.~Mean number of adenomas per procedure for each arm of the study in right colon and throughout the entire colon.~Mean number of polyps per procedure for each arm of the study in right colon and throughout the entire colon.~Number of neoplastic lesions for each arm of the study in the right colon and throughout the entire colon and number of neoplastic lesions missed on 1st pass of right colon.~Proportion of patients with diminutive lesions (< 5 mm) in each arm of the study~Proportion of patients with Flat lesions (height < 1/2 diameter) in each arm of the study~Proportion of patients with Sessile Serrated Adenoma in each arm of the study~Proportion of patients with invasive cancer in each arm of the study~Presence or absence of learning effect while using this technology given that use of I-Scan may train the human eye to better identify adenomas even without image enhancement.
Inclusion criteria: inclusion criteria:

 All increased risk patients (Patients with family history or personal history of colon polyps or colon cancer and FOBT positive) referred for a screening colonoscopy at the Forzani and MacPhail Colon Cancer Screening Centre will be considered for enrollment.

Exclusion criteria: :

 Average Risk patients

 Previous colon surgery

 Hereditary Polyposis Syndromes

 Suspected polyps or CRC before colonoscopy that have been suggested by another modality (Barium Enema, Virtual Colonoscopy, Flexible Sigmoidoscopy)


A Study to Evaluate the Effect of a Medicine on Gastric Functions in Healthy Volunteers.

Summary: A 7 day study which involves 2 nutrient drink tests, an ECG, a Scintigraphy scan, and a Sect scan. This study requires the participant to make 4 visits to the GCRC in the Charlton building but no overnight stays.
Inclusion criteria: Non-pregnant, non-breastfeeding females;

 18- 45 years old

 Body mass index between 20 and 32 kg/m2

 No alarm indicators on clinical assessment (weight loss of more than 7kg, bleeding, recent recurrent vomiting, progressive dysphagia).

 No history suggestive of small bowel obstruction
Exclusion criteria:


Study to Estimate the Disease Burden of Acute Rotavirus Gastroenteritis in Children < 5 Years in United Arab Emirates

Summary: The purpose of this study is to estimate the disease burden and epidemiology of rotavirus gastroenteritis in children less than 5 years of age, in United Arab Emirates. Acute gastroenteritis cases will be identified from acute gastroenteritis hospitalisation log book and stool samples will be collected from all suspected and confirmed acute gastroenteritis cases.
Inclusion criteria: inclusion criteria:

 A male or female < 5 years of age at the time of admission to the study hospital for acute gastroenteritis.

 Written informed consent obtained from the parent or guardian of the subject.

Exclusion criteria: :

 The diagnosis for treatment at the study site does not include acute gastroenteritis.

 The onset of acute gastroenteritis after admission to the hospital i.e. 48 hours after hospital admission.


Study on the Efficacy of Phenytoin in the Prophylaxis of Seizures of Patients With Pneumococcal Meningitis at Least 50 Yrs Old.

Summary: To evaluate the efficacy of the prophylaxis with phenytoin in the prevention of seizures in patients with pneumococcal meningitis. Hypothesis: Administration of prophylactic phenytoin will reduce the incidence of seizures in patients with pneumococcal meningitis older than 50 yrs.
Inclusion criteria: inclusion criteria:

 Adult patients > or = 50 years old.

 Diagnosed of pneumococcal meningitis due to clinical characteristics plus a positive CSF Gram stain and/or a detection of pneumococcal antigen or PCR

 or

 Suspected pneumococcal meningitis since it is an episode related to otitis, pneumonia, sinusitis or pericranial fistula or in patients with known risk factors such as myeloma or splenectomy.

Exclusion criteria: :

 To have seizures prior to arrive to the hospital or the inclusion in the study.

 Pregnancy or breastfeeding.

 To have conduction abnormalities in ECG.

 History of allergy or intolerance to phenytoin.

 Patients with meningitis as a complication of neurosurgical procedures.

 Epileptic patients taking usually anticonvulsivants.

 Refusal by the patient or family to participate and/or to sign the informed consent.