Clinical Trial to Evaluate the Accuracy of [99mTc] ThromboView in the Detection of Deep Vein Thrombosis

Summary: The assessment of patients with suspected deep vein thrombosis (DVT) is a common clinical scenario that, despite major advances in diagnostic testing, continues to be challenging.~The diagnosis of DVT remains problematic in:~patients with suspected first DVT who have a moderate or high pre-test probability (PTP) for DVT and a normal compression ultrasound (CUS);~patients with suspected recurrent DVT; and~patients in whom CUS or contrast venography is technically difficult or not feasible due to patient characteristics.~In patients with suspected first DVT who have a moderate or high PTP and a normal CUS, DVT occurs in up to 10% of cases. Thus, additional diagnostic testing is required, such as venography or serial CUS, so that DVT is not missed, but these approaches are costly and invasive.~In patients with suspected recurrent DVT, currently used diagnostic approaches are problematic because they all have limitations in differentiating old disease from true recurrent disease.~CUS is technically difficult in selected patients, particularly those who are obese.~Contrast venography is the gold standard diagnostic test for DVT to which all other diagnostic venous imaging modalities for DVT are compared and judged. The Food and Drug Administration (FDA) requires that a new diagnostic test for DVT be assessed against venography.~[99mTc] ThromboView® is a novel diagnostic test based on a 99mTc-labeled monoclonal antibody specific for D-dimer fragments of cross-linked fibrin that are found in acute DVT. After intravenous injection of [99mTc] ThromboView®, there is uptake of the monoclonal antibody by acute, D-dimer rich, venous thrombi. This is visualized with nuclear medicine imaging as an area of increased radioisotope activity that corresponds to the location of DVT.~Based on the biologic and imaging characteristics of [99mTc] ThromboView®, this diagnostic test has the potential to:~identify small non-occlusive proximal DVT or distal DVT in patients with a moderate or high PTP and normal CUS;~differentiate old from new DVT in patients with suspected recurrent DVT;~diagnose or exclude DVT in patients in whom CUS is not technically feasible; and~provide an alternative to venography that is non-invasive, has no contrast-related toxicity and is easily administered.~The present study is the first phase II clinical trial of [99mTc] ThromboView® in patients with suspected initial or recurrent DVT in whom DVT has been confirmed or excluded by venography. A phase II clinical trial to investigate the diagnostic accuracy of [99mTc] ThromboView® is justified because:~ThromboView® was well tolerated, with no significant toxicity in studies involving animals and healthy volunteers; and~it has shown promise in Phase I trials as a non-invasive diagnostic test for acute DVT.
Inclusion criteria: inclusion criteria:

 Adult man or woman, aged ≥18 years, presenting with suspected lower-limb initial or recurrent DVT.

 Moderate or high pre-test probability (PTP) for DVT.

 Onset of symptoms occurred within the last 7 days.

 Women of childbearing potential to have a negative pregnancy test as determined by measuring serum β-hCG levels at time of study enrolment.

Exclusion criteria: :

 Receiving anticoagulant therapy at therapeutic doses for >3 days.

 Life expectancy <3 months.

 Patient with a renal transplant.

 Renal dysfunction: serum creatinine >1.5x upper limit of normal range.

 Hepatic dysfunction: serum transaminases >3x upper limit of normal range.

 Current pregnancy or lactation; or conception intended within 90 days of enrolment

 Of childbearing potential and unwilling to use adequate contraception for 30 days following enrolment

 Unable to undergo lower limb ascending venography on symptomatic leg(s).

 Allergy or other contraindication to intravenous contrast dye.

 Prior exposure to murine or humanized antibodies.

 Prior imaging studies with: I131 within the last month; In111 or Ga67 within the last 2 weeks; Tc99m labelled RBCs, WBCs or albumin within the last 48 hours; Tc99m or F18 within the last 24 hours; prior non-imaging, non-therapeutic nuclear medicine studies with I131 (eg., 24-hour RAI uptake) within the last 2 weeks.

 Previous participation in the present study.

 Geographic inaccessibility that precludes follow-up visits.

 Patient is unwilling or unable to provide informed consent.

 Patient is unsuitable for the study, at the Study Investigator's discretion.


Efficacy and Safety of Valsartan Versus Amlodipine in Postmenopausal Women With Hypertension

Summary: The purpose of this study is compare treatment with valsartan with the possible addition of a diuretic, hydrochlorothiazide, on high blood pressure with the drug amlodipine with the possible addition of a diuretic, hydrochlorothiazide. In particular, the effect of treatment on the stiffness of the blood vessels will be studied.
Inclusion criteria: inclusion criteria:

 Postmenopausal women

 Mild to moderate hypertension

 Statin therapy or LDL≤ 4.1 mmol/L

Exclusion criteria: :

 Severe hypertension

 LDL > 4.1 mmol/L if not taking anti-hyperlipidemic medication

 Certain hormonal therapy

 History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm

 Liver, kidney, or pancreas disease

 Diabetes

 Raynaud's disease or any other significant peripheral vascular disease

 Allergy to certain medications used to treat high blood pressure

 Other protocol-defined inclusion/

['Valsartan 320 mg', 'Amlodipine 10 mg', 'Hydrochlorothiazide']

Valsartan 320 mg
Amlodipine 10 mg
Hydrochlorothiazide


Effect of Anesthesia on Post-operative Delirium in Elderly Patients Undergoing Hip Fracture Surgery

Summary: The purpose of this study is evaluate postoperative delirium after general anesthesia and regional anesthesia in elderly patients undergoing hip fracture surgery. Our research hypotheses are: (1) regional anesthesia may contribute to decrease the incidence of postoperative delirium. (2) Regional anesthesia may improve the outcome of elderly patient and reduce healthcare costs associated with postoperative delirium. (3) Postoperative delirium may result in poor long-term functional outcomes.
Inclusion criteria: inclusion criteria:

 older patient (≥65 years)

 patient with hip fracture and planned hip fracture surgery

 patient willing to complete this study.

Exclusion criteria: :

 patient with multiple trauma or multiple fractures, pathological fractures, pelvic fractures, femur fractures

 contraindication (serious illness or medical conditions) for general anesthesia

 contraindication (infection at the site of needle insertion, coagulopathy, international normalized ratio >1.4, platelet count <80×109 litre-1, allergy to local anaesthetics and so on) for regional anesthesia;

 patient who cannot complete the preoperative mental tests (CAM and/or Mini-Mental State Examination (MMSE)) of this clinical trial

 patient known to susceptible to malignant hyperthermia

 known allergy or hypersensitivity to any drugs administered during this clinical trial

 previous participation in this clinical trial

 participation in another clinical trial within 4 weeks prior to selection


Epi Cystic Hydatid Disease Peru

Summary: This is a study developed by researchers from the Universidad Peruana Cayetano Heredia, the Universidad Mayor de San Marcos and other local and foreign institutions. Researchers are performing this research in human beings and animals, in order to determine the best way to understand and eliminate a parasite called Echinococcus granulosus (tapeworm). The parasite grows and develops in the dogs´ bowel. The tapeworm produces eggs which are eliminated among the feces and remain in the environment. Individuals may accidentally ingest the eggs through contaminated food or drinks and develop a disease called cystic hydatid disease. This disease mainly affects the human lungs and liver. The parasite grows in the shape of a water bag and it can jeopardize human life. It also affects sheep, goats, llamas and alpacas. The study will enroll almost 840 volunteers who are older than 5 years of age. It will last about 3 years.
Inclusion criteria: inclusion criteria:

 Living in study area (Cooperative Tupac Amaru).

 Older than five-years old

Exclusion criteria: :

 1. Pregnant woman (only for chest X-ray procedure).


The Effect of Omalizumab on Responses to Cat Allergen Challenge

Summary: This research is being done to study the effects of the drug omalizumab (Xolair) in people with cat allergies. The investigators will use omalizumab to study changes in the cells in the nose, skin and blood that cause allergies. The investigators predict that cells in the blood will be effected before cells in the nose or skin.
Inclusion criteria: inclusion criteria:

 Ability to understand and provide informed consent

 Male or Female (non-pregnant), age 18-50

 Females must be: Surgically sterile (hysterectomy, bilateral oophorectomy, bilateral tubal ligation), OR postmenopausal (at least 1 year since last menses), OR using a medically acceptable form of birth control throughout the duration of the study.

 Clinical history of seasonal or perennial allergic rhinitis for at least two years, with or without mild persistent asthma

 Positive puncture skin test greater than or equal to 5 mm diluent control

 Positive Immunocap to Fel d 1 > 0.35 kallikrein unit/L

 Positive intranasal cat allergen challenge as defined by > 5 sneezes or a tripling of measured nasal lavage mediators

 In vitro assay of basophil responsiveness to cat allergen with greater than 20% histamine release

 The use of antihistamines, cromolyn, leukotriene modifiers and other non-steroid (astelin and topical decongestants), nasal medications will be allowed, but they will be withheld for 5 days prior to each nasal allergen provocation session. Inhaled corticosteroids for mild asthma will be permissible.

 No known contraindications to therapy with omalizumab

Exclusion criteria: :

 Asthma with forced expiratory volume at one second (FEV1) < 80%, moderate to severe asthma classification per National Asthma Education and Prevention Program Expert Panel (NAEP) Standards (1997 National Asthma Education and Prevention Program Expert Panel Report II guidelines)

 Serum IgE levels less than 30 IU/mL or greater than 700 IU/mL at the time of enrollment will be excluded

 Unexplained elevation of erythrocyte sedimentation rate (ESR), hematocrit < 32%, white blood cell (WBC) count 2400/microliter lower limit of normal, platelet < 75000/microliter, creatinine > 141.4 micromolar/L, or aspartate aminotransferase (AST) > 100 IU/L

 Body weight less than 30 kg or greater than 150 kg will be excluded.

 Plans to become pregnant or breastfeed will be excluded from the study

 A perforated nasal septum, structural nasal defect, large nasal polyps causing obstruction, evidence of acute or chronic sinusitis

 A life expectancy less than 6 months

 A terminal illness as determined by the investigator

 A history of malignancy, anaphylaxis or bleeding disorder are also exclusion illnesses.

 Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.

 Inability or unwillingness of a participant to give written informed consent or comply with study protocol

 Use of any investigational drugs within 8 weeks of participation

 Contraindications to omalizumab include patients with a previous hypersensitivity to omalizumab

 Recent recipient of any licensed or investigational live attenuated vaccine(s) within two months of study initiation such as flu mist.

 Prior use of omalizumab

 Frequent sinusitis (>2/ documented episodes per year) or active sinusitis within 2 weeks of enrollment

 Use of immunotherapy within the last 5 years


COOL-Trial: Outcome With Invasive and Non-invasive Cooling After Cardiac Arrest

Summary: Sudden cardiac arrest (SCA) remains one of the major leading causes of death. Cognitive deficits are common in survivors of SCA. Postresuscitative mild induced hypothermia (MIH) lowers mortality and reduces neurologic damage after cardiac arrest. The investigators evaluated the efficacy and side effects of therapeutic hypothermia in an unselected group of patients after SCA.
Inclusion criteria: inclusion criteria:

 ROSC after SCA due to VF/VT or PEA/Asystolia

 GCS 3

Exclusion criteria: :

 Non-cardiac SCA

 Pregnancy

 Unstable Circulation instead of High-dose Inotropics

 Life-expectancy reducing concomitant illness

['Coolgard', 'ArcticSun', 'Conventional treatment']

Coolgard
ArcticSun
Conventional treatment


DHA & Lutein and fMRI Brain Mapping in Healthy Children

Summary: Studies suggest that lutein and n-3 fatty acids may influence the development of a child's brain and may be related to how well children learn. Both lutein and the n-3 fats (also known as omega-3 fats) are not made by the body and must be obtained in the diet. The investigators are interested to understand the importance of n-3 fats and lutein to child brain development. Functional magnetic resonance imaging (fMRI) will make it possible to look into the brain from the outside and see which parts of the brain are being used as children complete working memory tasks. The investigators will study brain function using fMRI among children with different intakes of n-3 fats and lutein.~Hypothesis:~Children 6 years of age consuming < 25 mg/day DHA and < 400 μg lutein/day will show poorer activation of brain areas on fMRI than children consuming > 150 mg/day DHA and > 1,200 μg/day lutein.~Children consuming < 400 μg lutein/day and > 150 mg/day DHA will also show differences in fMRI results when compared to children consuming > 150 mg/day DHA and > 1,200 μg/day lutein.
Inclusion criteria: inclusion criteria:

 full-term

 single birth (no multiple births)

 no major illness or surgery requiring hospitalization likely to impact the outcomes

 no metabolic, congenital or allergic disease that impact food intakes

 parents have sufficient command of English language to complete the informed consent and study documents

 The specific inclusion enrollment criteria for:

 Group 1: children consuming <25 mg/day DHA and < 400 μg/day lutein, n=24; Group 2: children consuming >150 mg/day DHA and >1,200 μg/day lutein, n=24; Group 3: children consuming >150 mg/day DHA and <400 μg/day lutein, n=10;

Exclusion criteria: :

 children of mothers enrolled in studies by our group that involved randomization to supplemental DHA during pregnancy

 children for whom blood, diet records or developmental tests at 5 years and 9 months of age are incomplete

 children consuming 25-150 mg/day DHA or 400-1200 μg/day lutein

 children of mothers who do not sign the informed consent

 any children having a cardiac pacemaker, aneurysm clip, cochlear implant of possible metallic foreign bodies in the eyes or other contraindication as detailed in the C&W MRI Patient Screening Form will be excluded from this study.

['Focus of Study: Association of Blood DHA and Lutein With Cognition in Children']


VergenixTM Flowable Gel in Patients With Lower Limb Ulcers

Summary: Vergenix Flowable Gel is indicated for the management of acute and chronic wounds
Inclusion criteria: inclusion criteria:

 Patient is 18 years of age or older.

 2. Patient has one of the following difficult-to-treat chronic ulcers in the

 lower limb:

 2.1. Neuropathic lower limb ulcer

 2.2. Venous lower limb ulcer

 2.3. Post traumatic lower limb ulcer

 2.4. Post operative lower limb ulcer

 3. In case of Neuropathic foot grade according to University of Texas

 Classification 1A

 4. Wound area measurement ranging between 1-20cm2.

 5. Ulcer defined as grade ≥E on the granulometer scale.

 6. Willing to adhere to the proper off-loading device (off loading cast,

 healing shoe) according to investigator recommendation.

 7. Female patients must have a negative serum pregnancy test at

 screening and be willing and able to use a medically acceptable

 method of birth control or declare that they are abstaining from sexual

 intercourse, from the screening visit through the study termination

 visit or be surgically sterile (bilateral tubal ligation, bilateral

 oophorectomy, or hysterectomy) or post-menopausal. Postmenopausal

 women are defined as women with menstruation cessation for

 12 consecutive months prior to signing of the informed consent form.

 8. Ability and willingness to understand and comply with study

 procedures and to give written informed consent prior to enrollment in

 the study.

Exclusion criteria: :

 Acute ulcer

 Multiple Ulcers on the lower limb.

 Clinical evidence of infection in the soft tissue, joint and/or bone

 (osteomyelitis) as presented in the physical examination.

 The wound is penetrating into deep structures and involves bone,

 tendon or joint.

 Wound has necrotic tissue.

 Wound with sinus tracts.

 HbA1c>12.

 Patients with any other skin disorder unrelated to the ulcer that is

 presented in adjacent to the target wound.

 Clinically significant arterial vascular disease with Ankle-Brachial Index (ABI) index <0.45

 if the peripheral pulse is not palpable, or flatted Pulse Volume Recording (PVR) in case of non

 palpable arteries.

 Patient is receiving, or has received within one month prior to

 enrollment any treatment known to impair wound healing, including

 but not limited to:, immunosuppressive drugs, cytotoxic agents,

 radiation therapy and chemotherapy.

 Has active malignant disease of any kind. A patient, who has had a

 malignant disease in the past, was treated and is currently disease-free

 for at least 5 years, may be considered for study entry.

 Patients who present with significant metabolic co-morbidity that

 would preclude wound healing such as end stage renal failure, dialysis

 or severe liver dysfunction.

 Clinically significant abnormalities in hematology and blood

 chemistry lab tests at screening that in the opinion of the investigator

 might interfere with the patient's safety or participation in the study.

 Known positive HIV.

 Known history of a significant medical disorder, which in the

 investigator's judgment contraindicates the patient's participation.

 Known hypersensitivity and/or allergy to collagen.

 Drug or alcohol abuse (by history).

 Patients participating in any other clinical trials.

 Patients with inability to communicate well with the investigators and

 staff (i.e., language problem, poor mental development or impaired

 cerebral function).


the Role of Total Body Imaging in Asymptomatic Pediatric Trauma Patients

Summary: Whole body imaging has no role in asymptomatic pediatric trauma patients
Inclusion criteria: inclusion criteria:

 All asymptomatic trauma patients from 0 to 15 years old

Exclusion criteria: :

 Any pediatric trauma patients with clinical indications for CT scan


Gastric Bypass After Previous Anti-reflux Surgery

Summary: The goal of this study is to describe the clinical presentation, indications, and operative treatment as well as assess the morbidity, mortality, and overall performance of revisional Roux-en-Y gastric bypass (RYGB) after either failed or functional antireflux surgery ARS in obese patients. With such information, we hope to determine which features might assist us in advancing our knowledge about Gastro-Esophageal Reflux Disease GERD, the best option for primary ARS, and mechanisms of failure in the obese population as well as in identifying predictors of outcome after revisional surgery in this population.
Inclusion criteria: inclusion criteria:

 Status post, either open or laparoscopic, primary Nissen fundoplication with all the following requirements:

 Met NIH criteria for bariatric surgery

 With functional or failed antireflux surgery (Nissen fundoplication)

 Laparoscopic approach for revisional surgery

Exclusion criteria: :

 Any other type of revisional bariatric procedure

 Nonstandard revisional RYGB surgery

 Open approach for revision surgery

 Missing records and/or unreachable patients with scant information for analysis

['Clinically Severe Obesity', 'Gastroesophageal Reflux Disease']

Clinically Severe Obesity
Gastroesophageal Reflux Disease


Enoxaparin Low Molecular Weight Heparin (LMWH) in Advanced Non Small Cell Lung Cancer: Effect on Survival and Symptom Control in Patients Undergoing First Line Chemotherapy (SYRINGES)

Summary: Rationale: a number of recent phase III randomized trials have shown a survival benefit of a treatment with subcutaneous low-molecular weight heparin in patients with advanced solid malignancies. The survival advantages observed in the studies persist for months after the active treatment with LMWHs. Therefore these survival advantages are thought to be due to effects of LMWHs on tumor cell biology.~First line treatment of advanced NSCLC patients with the Cisplatin + Docetaxel combination has been widely studied, and is amongst the most active treatments currently available. The occurrence of grade 3/4 thrombopenia in several phase III trials was in the 0-3% range, making it an ideal chemotherapy regimen to combine with LMWHs in the treatment of advanced NSCLC.
Inclusion criteria: inclusion criteria:

 Locally advanced or metastatic NSCLC (stage IIIB or IV)

 Patients who are not candidates for radical combined modality treatments or high-dose radiation therapy

 At least one measurable lesion according to RECIST criteria

 Good performance status

 Adequate haematological, renal and liver function

 Written informed consent

Exclusion criteria: :

 Previous chemotherapy for NSCLC

 Brain metastasis

 History of cerebral haemorrhage, neurosurgery within 3 previous months or surgery within the past 6 months

 Indication for anticoagulant therapy, thrombolytic therapy or antiplatelet therapy for cardiovascular disease

 Concomitant therapy with an anti-angiogenesis agent

 Contra-indication for LMWH

 Life expectancy of < 3 months

 Serious concomitant systemic disease, uncontrolled arterial hypertension, active peptic ulcer or other condition which does not permit study treatment or follow-up required to comply with the study protocol

['cisplatin + docetaxel', 'cisplatin + docetaxel + enoxaparin']

cisplatin + docetaxel
cisplatin + docetaxel + enoxaparin


Intralesional Cryosurgery for Basal Cell Carcinoma - a Feasibility Study

Summary: A feasibility study for the treatment of Basal Cell Carcinoma of the lower extremities in the elderly utilizing intralesional cryosurgery.~10 cases of BCC (confirmed by biopsy) in the lower extremity of elderly will undergo intralesional cryotherapy. A Cryoneedle is introduced through the skin lesion (BCC) and thus the BCC is frozen. Treatment success will be determined according to biopsy results 3 months after treatment
Inclusion criteria: inclusion criteria:

 Patients over 60 years old

 BCC was determined with tissue diagnosis in the lower extremity

 One or more risk factor for surgical complication including: diabetes, venous insufficiency, obesity, peripheral vascular disease, lymphedema and long term steroids use.

Exclusion criteria: :

 Patient unable to read, understand and sign the consent form


Laparoscopic Gastric Plication Operation for Patients With Severe or Morbid Obesity

Summary: The purpose of this study is to collect data prospectively on the safety and efficacy of the Laparoscopic Gastric Plication operation for patients with Severe or Morbid Obesity.~The 95% confidence interval for average percentage of weight loss and body mass index will be computed at 6 months, one year and then annually. Analysis of comorbid conditions changes, quality of life and adverse events will be performed. With 50 subjects in the study, limited power is expected and no formal hypothesis testing will be performed.
Inclusion criteria: inclusion criteria:

 Age: 18 - 60 years

 BMI 35-39.9 kg/m2 with one or more severe co-morbid conditions or BMI 40-55 kg/m2

 Willingness to comply with dietary restrictions required by the protocol

 History of obesity for at least 5 years

 History of at least 6 months of documented failures with traditional non-surgical weight loss methods

 Willingness to follow protocol requirements which include: signing the informed consent form, completing routine follow-up visits for the study duration, and completing all pre- and post-operative laboratory and diagnostics tests in addition to the quality of life questionnaire

 If female with childbearing potential, using an appropriate form of contraception

Exclusion criteria: :

 Age less than 18, age greater than 60

 Pregnancy

 History of major depressive disorder or psychosis

 Previous bariatric surgery or previous gastric surgery

 Presence of achalasia

 Any condition that, in the judgment of the investigator, would place a subject at undue risk, or could potentially compromise the results or interpretation of the study


Prevalence of Small Bowel Polyps in Patients With Sporadic Duodenal Adenomas

Summary: Little is known about the prevalence of small bowel polyps in patients with sporadic Duodenal/Ampullary polyps. The investigators aim to investigate the prevalence of small bowel polyps in patients with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas by performing small bowel capsule endoscopy and comparing the results to those acquired from a control cohort undergoing VCE for accepted indication at our centre.
Inclusion criteria: inclusion criteria:

 Cases - Patients who were diagnosed with or underwent resection of a duodenal adenoma/ampulloma at Westmead hospital between the years 2005-2014.

 Controls - Patients undergoing VCE procedure for the evaluation of obscure gastrointestinal bleeding (OGIB) or Iron deficiency anemia (IDA).

Exclusion criteria: :

 None

['Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTD']


Effect of Remote Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation

Summary: The purpose of this study was to investigate whether lower limb ischaemic preconditioning can improve renal function in patients undergoing living donor kidney transplantation
Inclusion criteria: inclusion criteria:

 Subject capable of giving written informed consent, with end-stage kidney disease, who is a suitable candidate for primary kidney transplantation

 Living donors

 Compatible ABO blood type

 PRA < 20%

Exclusion criteria: :

 Re-transplant patients

 Those with peripheral vascular disease affecting the lower limbs

['Kidney Diseases', 'Kidney Failure, Chronic', 'Kidney Failure', 'Renal Insufficiency', 'Renal Insufficiency, Chronic', 'Urologic Diseases']

Kidney Diseases
Kidney Failure
Chronic
Kidney Failure
Renal Insufficiency
Renal Insufficiency
Chronic
Urologic Diseases


Evaluating Behavioral Treatments to Improve Adherence to Continuous Positive Airway Pressure (CPAP) Therapy in People With Obstructive Sleep Apnea (The BREATHE Study)

Summary: Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person repeatedly stops breathing or experiences shallow breathing for short periods of time during sleep. The most common treatment for OSA is the use of a continuous positive airway pressure (CPAP) machine, but many people have trouble adhering to the treatment schedule. This study will evaluate the effectiveness of two behavioral therapy programs used in combination with CPAP for improving treatment adherence in people with OSA.
Inclusion criteria: inclusion criteria:

 OSA confirmed by polysomnography (PSG)

 CPAP is the prescribed form of treatment for OSA

 Judged by sleep physician to respond to CPAP

Exclusion criteria: :

 Apnea/hypoxia index (AHI) less than 15 and no daytime functional symptoms or associated cardiovascular disease

 Diagnosis of another sleep disorder that causes arousals from sleep

 Past treatment for OSA

 Current substance abuse problem

 Diagnosis of a serious medical condition that would interfere with involvement in the study

 History of a major psychiatric disorder, other than depression

 Change in antidepressant medication in the 3 months before study entry

['Sleep Apnea, Obstructive', 'Continuous Positive Airway Pressure']

Sleep Apnea
Obstructive
Continuous Positive Airway Pressure


CF And Effects of Drugs Mixed Ex Vivo With Sputum for Mucolytic Treatment

Summary: The investigators will collect samples of sputum from healthy volunteers and patients with cystic fibrosis for the purpose of: a) purifying airway mucins for plate-based binding studies and; b) assessment of the effects of carbohydrates on the rheologic properties of the sputum.~This study has two hypotheses:~Lectins from Pseudomonas aeruginosa and Aspergillus fumigatus bind to airway mucins in a fucose-dependent manner, and this binding can be inhibited by fucosyl glycomimetic compounds.~Fucosyl glycomimetics will compete with Pseudomonas aeruginosa lectin (PA-IIL) and Aspergillus fumigatus lectin (AFL) and disrupt lectin-driven mucin cross-linking in CF sputum.
Inclusion criteria: inclusion criteria:

 Healthy control subjects:

 Age 18-65

 No history of lung disease

 Cystic fibrosis subjects:

 Age 18-65

 No history of lung disease other than cystic fibrosis

 Diagnosis of CF if sweat chloride values > 60 mM on two separate pilocarpine iontophoresis sweat tests and/or two allelic CF-producing mutations in genetic analysis

Exclusion criteria: :

 Use of recreational drugs within 30 days prior to enrollment

 Use of tobacco within 30 days prior to enrollment, or > 10 pack-year tobacco history

 Pregnant or lactating females


Phase II Study of Icotinib With Concurrent Radiotherapy in Elderly Patients With Esophageal Cancer

Summary: To investigate the efficacy and toxicity of EGFR tyrosine-kinase inhibitor (Icotinib) with concurrent radiotherapy in older patients with esophageal cancer.
Inclusion criteria: inclusion criteria:

 Pathologically confirmed esophageal carcinoma

 Stage I～Iva By EUS and CT/MRI, without contraindication for radical radiotherapy

 Aged ≥ 70 and < 85 years, behavioral status evaluation ECOG scores 0-2

 In 7 days after being screened, subjects should follow the status: WBC ≥ 3.0 x 10^9/L; ANC ≥ 1.5x 10^9/L; PLT ≥ 80 x 10^9/L; Hb ≥ 90 g/L; serum Cr ≤ ULN; serum bilirubin ≤ 1.5 ULN; ALT/AST ≤ 1.5 ULN

 Subjects should sign for the informed consent

 Subjects should perform good compliance

Exclusion criteria: :

 Patients who have or are currently undergoing additional chemotherapy, radiation therapy or targeted therapy

 Complete obstruction of the esophagus, or patients who have the potential to develop perforation

 Patients with a history of malignancy (except that skin carcinomas or in situ breast cancer, oral cancer and cervical cancer with expected survival ≥2 years

 Patients who have multiple foci esophageal carcinomas

 Patients who are/were given any other medicine tests currently/in last 4 weeks

 Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines

 Patients who have complications as following:

 (1) Uncontrolled angina and heart failure, have a history of hospitalization in 3 months; (2) A history of myocardial infarction in the past 6 months; (3) There is a need for antibiotic treatment of acute bacterial or fungal infection; (4) Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization; (5) Drug addiction, alcoholism and AIDS disease or long-term virus carriers; (6) Uncontrollable seizures, or loss of insight because of mental illness.


Comparison Study of Standard Care Against Combination of Growth Factors Agents for Low-risk Myelodysplastic Syndromes

Summary: REGIME is comparing two treatments, with Darbepoetin Alpha (DA) and Filgrastim (Granulocyte Colony Stimulating Factor, G-CSF), to the standard treatment for Myelodysplastic Syndrome (MDS).~After giving Informed Consent patients will undergo a number of tests to confirm eligibility. Once eligibility is confirmed patients will be randomly assigned to one of the three treatments group: A: Darbepoetin Alpha (DA), B: Darbepoetin Alpha and Filgrastim (DA+G-CSF), C: Blood transfusion only. Patients will be required to attend the clinic once a month for 24 weeks. After 24 weeks if a patient has reacted favorably to the treatment they may continue on the treatment regime up to 52 weeks. After week 24 all patients will be required to attend the clinic twice more, at week 36 and 52.~Patients will be followed for a further 5 years to record loss of response, transformation to Acute Myeloid Leukaemia and/or Refractory Anemia with Excess Blasts and death.
Inclusion criteria: inclusion criteria:

 Males and females aged over 18 years, (no upper age limit)

 ECOG performance status 0-2

 Life expectancy more than 6 months

 A confirmed diagnosis of MDS - WHO type:

 refractory anaemia (RA)

 hypoplastic RA ineligible for/or failed immunosuppressive therapy (ALG, cyclosporine)

 refractory anaemia with ring sideroblasts (RARS)

 refractory cytopenia with multilineage dysplasia

 myelodysplastic syndrome unclassifiable

 IPSS low or Int-1, but with BM blasts less than 5%

 A haemoglobin concentration of less than 10g/dl and/or red cell transfusion dependence

 Able to understand the implications of participation in the Trial and give written informed consent.

Exclusion criteria: :

 MDS with bone marrow blasts greater or equal than 5%

 Myelodysplastic syndrome associated with del(5q)(q31-33) syndrome

 Chronic myelomonocytic leukaemia (monocytes greater than1.0x109/l)

 Therapy-related MDS

 Splenomegaly, with spleen greater or equal than 5 cm from left costal margin

 Platelets less than 30x109/l

 Uncorrected haematinic deficiency. Patient deplete to iron, B12 and folate according to local lab ranges

 Women who are pregnant or lactating.

 Females of childbearing potential and all males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) for the duration of the study and for up to 3 months after the last dose of study medication. Note: Subjects are not considered of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal

 Females of childbearing potential must have a negative pregnancy test prior to starting the study.

 Uncontrolled hypertension, previous venous thromboembolism, or uncontrolled cardiac or pulmonary disease

 Previous serious adverse events to the study medications or its components

 Patients who have had previous therapy with ESAs ± G-CSF within 4 weeks of study entry

 Patients currently receiving experimental therapy, e.g. with thalidomide, or who are participating in another CTIMP.

 Medical or psychiatric illness, which makes the patient unsuitable or unable to give informed consent.

 Patients with malignancy requiring active treatment (except hormonal therapy).

 Patients with a history of seizures

['Darbepoetin alpha', 'Filgrastim', 'Blood Red Cell Transfusion']

Darbepoetin alpha
Filgrastim
Blood Red Cell Transfusion


Fenoldopam and Ketanserin for Acute Kidney Failure Prevention After Cardiac Surgery

Summary: The purpose of the study is to compare the effect of fenoldopam and ketanserin on kidney function preservation in patients at high risk for renal failure after cardiac surgery. Acute, oliguric renal failure develops in up to 2% of patients undergoing cardiac surgery. Some of them require renal replacement therapy and despite that mortality in this group exceeds 30-60%. The investigators await that the use of fenoldopam and/or ketanserin may decrease the rate of severe renal failure.
Inclusion criteria: inclusion criteria:

 cardiac surgery

 at least one risk factor for acute renal failure:

 oliguria < 0.5 ml/kg/hour for over 3 hours despite adequate blood volume and furosemide intravenously

 at least 60 mg furosemide/12 hours iv to maintain diuresis > 1 ml/kg/hour

Exclusion criteria: :

 refused or none consent

 chronic renal failure with chronic renal replacement therapy

 chronic increase of serum creatinine > 2 mg/dl

['fenoldopam (Corlopam)', 'placebo', 'ketanserin (Sufrexal)']

fenoldopam (Corlopam)
placebo
ketanserin (Sufrexal)


Evaluation of a Non-invasive Brain Compliance Measurement Device

Summary: This is a research study to understand how diabetic ketoacidosis may affect the brain and learning and to see if these changes are transient or permanent. The investigators hope to learn more about how diabetic ketoacidosis may cause changes in brain compliance (by wearing a non-invasive head band/helmet like device from Jan Medical: The Nautilus Neurowave System™ (NNS), learning, talking, behavior, or development. The investigators will compare those results from those with diabetes mellitus to those age and gendered matched healthy controls. Possible subjects in this study have diabetes mellitus and are between the ages of 10 to less than 17 years old OR do NOT have diabetes and are between the ages of 10 to less than 17 years old.
Inclusion criteria: inclusion criteria:

 To be eligible for the study, all subjects must meet the following criteria:

 Healthy control OR

 Clinical new onset or established diagnosis of diabetes with diabetes ketoacidosis as defined by the Pediatric Endocrine Society Consensus Statement guidelines

 Age 10 years to less than 17 years

 Parent/guardian understand the study protocol and agrees to comply with it.

 Primary care giver (i.e parent/guardian) comprehends written English. This is due to the fact that questionnaires and neurocognitive testing tools used as outcome measures do not have validated versions in Spanish or other language. Subject comprehends and speaks English.

Exclusion criteria: :

 Subjects who meet any of the following criteria are not eligible for the study:

 History of head trauma with any loss of consciousness

 History of premature birth (less than 30 weeks of gestation)

 History of significant developmental delay (lack of single word speech or ability to walk independently by 18 months of age

 History of neurologic disease independent of diabetes (seizure disorder)

['this is not an intervention study', 'this is not an intervention study', 'MRI']

this is not an intervention study
this is not an intervention study
MRI


Comparison of the Effects of Gelatine Versus Balanced Crystalloid Solution for Volume Therapy

Summary: The purpose of the study is to determine whether volume therapy with a solution of gelatine has negative impact on coagulation, platelet function, renal function in comparison with crystaloid solution (Ringerfundin).
Inclusion criteria: inclusion criteria:

 patient scheduled for elective hip replacement surgery

 age between 19-85 years

 signed informed consent

Exclusion criteria: :

 informed consent not signed

 traumatic hip fracture

 anemia (hemoglobin level < 100 g/l)

 allergy to study drug and/or multiple allergies

 chronic heart failure with LVEF < 30%

 shock states

 coagulopathy

 thrombocytopenia

 thrombocytopathy

 chronic kidney disease with oliguria

 chronic antiplatelet drug medications

['Gelofusine® B. Braun', 'Ringerfundin ® B. Braun']

Gelofusine® B. Braun
Ringerfundin ® B. Braun

['Hemorrhage, Surgical', 'Hip Replacement, Total', 'Thrombocytopathy']

Hemorrhage
Surgical
Hip Replacement
Total
Thrombocytopathy


Single Shot Versus OnQ Pump in Extremity Fractures

Summary: Peripheral nerve blocks have been well studied in the literature with generally good results for controlling post operative pain following orthopaedic surgery. Regional anesthesia has many benefits. It provides excellent intraoperative anesthesia and muscle relaxation as well as analgesia that continues into the post-operative period. These regional blocks are also effective in controlling pain in the immediate post-operative period. However, as the block wears off, patients begin experiencing increased pain. Compared to patients treated without regional blocks, these patients will often experience a rebound pain--pain occurring 12-24 hours after surgery that is subjectively worse than that in patients treated without regional blocks. Therefore, the investigators propose to use a continuous infusion of anesthetic in order to provide sustained pain control post-operatively. Preoperatively, patients will be randomized into a single shot peripheral nerve block versus a continuous infusion of peripheral nerve block. Post-operatively, pain will be assessed using the Visual Analogue Scale (1-100) prior to being discharged from PACU. Time to discharge and amount of pain medication taken will be recorded. Patients will be contacted at certain time intervals postoperatively to assess their pain scale and pain medication intake. Patients will be seen for routine post-operative follow-up visits where they will be assessed for satisfaction, pain, residual neurological symptoms, and signs of infection.
Inclusion criteria: inclusion criteria:

 Patients at least 18 years old.

 Male or Female

 All racial and ethnic groups

 Fractures and fracture/dislocations of the foot, ankle, tibia, fibula, elbow, forearm, wrist and hand

 Patients who opt for surgical treatment of their fractures.

 Patients who consent to be randomized.

 Patients who are willing to follow-up for a minimum of 52 weeks.

Exclusion criteria: :

 Patients younger than 18 years old.

 Patients who are on chronic opioids

 Patients who abuse opioids

 Patients who are unwilling to follow-up for a minimum of 52 weeks.

 Neurologic condition that could interfere with pain sensation

['Ankle SSB', 'Ankle OnQ', 'DR SSB', 'DR OnQ']


Pediatric Adenotonsillectomy Trial for Snoring

Summary: The purpose of this study is to evaluate the effects of early adenotonsillectomy (eAT) on the behavior, sleep-disordered breathing symptoms and quality of life for children who snore, but do not have obstructive sleep apnea, as well as identify factors that moderate responses to the surgery. Half of participants will receive eAT, while the other half will be observed with watchful waiting and supportive care.
Inclusion criteria: inclusion criteria:

 Diagnosis of mild sleep-disordered breathing (MSDB) defined as meeting all of the following criteria:

 Caregiver report of habitual snoring that occurs most of the night on at least three nights per week, and has been present for at least three months (on average occurring > 3 nights per week or more half of sleep time) and

 Centrally-scored polysomnogram (PSG) confirming an obstructive apnea index (OAI) <1/hour and apnea-hypopnea index (AHI) ≤3/hour and no oxygen saturation (SpO2) desaturation < 90% in conjunction with obstructive events, confirmed on PSG.

 Tonsillar hypertrophy ≥2 based on a standardized scale of 0-4.

 Deemed to be a candidate for AT by otolaryngologist (ENT) evaluation (i.e., no technical issues that would be a contraindication for surgery such as submucous cleft palate.)

 Primary indication for AT is nocturnal obstructive symptoms (i.e., not recurrent infections or other indications).

Exclusion criteria: :

 Previous tonsillectomy, including partial tonsillectomy

 Recurrent tonsillitis that merits prompt adenotonsillectomy (AT) per the American Academy of Otolaryngology-Head and Neck Surgery Clinical Practice Guidelines (i.e., ≥7 episodes/yr in the past year; ≥5 episodes/year over the past 2 years or ≥3 episodes/yr over the past 3 years.)

 Severe obesity (body mass index (BMI) z-score ≥3).

 Failure to thrive, defined as either height or weight being below the 5th percentile for age and gender.

 Severe chronic health conditions that might hamper participation or confound key variables under study, including but not limited to:

 Severe cardiopulmonary disorders such as cystic fibrosis, and congenital heart disease.

 Bleeding disorders

 Sickle Cell Disease

 Epilepsy requiring medication

 Significant cardiac arrhythmia noted on PSG including: non-sustained ventricular tachycardia, atrial fibrillation, second degree atrioventricular block, sustained bradycardia, or sustained tachycardia.

 Other severe chronic health problems such as diabetes, narcolepsy, and poorly controlled asthma.

 Known genetic, craniofacial, neurological or psychiatric conditions likely to affect the airway, cognition or behavior;

 Current use of psychotropic medication (other than medications for attention deficit hyperactivity disorder, hypnotics, antihypertensives, hypoglycemic agents including insulin, anticonvulsants, anticoagulants, or growth hormone.

 Diagnosis of autism spectrum disorder.

 Intellectual deficit or assigned to a self-contained classroom for all academic subjects.

 History of severe developmental disability or Adaptive Behavior Assessment System (ABAS-3) score ≤60.

 Children/caregivers planning to move out of the area within the year.

 Children in foster care.

 Children/caregivers who do not speak English or Spanish well enough to complete the neurobehavioral measures.

['Early Adenotonsillectomy (eAT)', 'Watchful Waiting with Supportive Care (WWSC)']


Leuven Growing Into Deficit Follow-up Study

Summary: The key objective of the Leuven growing-into-deficit (GID) follow-up-study is to test the hypothesis that children with a congenital heart disease (CHD) show more neurocognitive impairment at the second follow-up at 7 years old than at the first follow-up at the age of 4, compared to healthy controls.
Inclusion criteria: inclusion criteria:

 Seven-year-old children with CHD and healthy control children who were four years old when they participated in Paediatric ICU follow-up study (i.e. first follow-up time point) (Neurocognitive development of children four years after critical illness and treatment with tight glucose control, Clinical Trials # NCT00214916). The children of the CHD-group underwent cardiac surgery as infants (=<1year).

Exclusion criteria: :

 Genetic syndromes (Down, 22q11del), known to result in neurocognitive impairment

 IQ < 70

 Lack of baseline neurocognitive measurements during first follow-up

 Date of birth before February 2005

['Heart Defects, Congenital', 'Critical Illness', 'Mental Processes', 'Child']

Heart Defects
Congenital
Critical Illness
Mental Processes
Child


Comparison of Ultrasound-Guided Needle Aspiration and Open Incision and Drainage for Cutaneous Abscesses

Summary: The investigators propose to conduct a, two armed, randomized, controlled pilot study to assess the clinical effects of a) open incision, drainage with daily packing changes, compared to b) Ultrasound guided needle aspiration, in drainage of uncomplicated cutaneous abscesses below the skin surface of adult emergency department patients using concealed allocation in evaluating patient satisfaction.
Inclusion criteria: inclusion criteria:

 Patients presenting to the Civic Campus emergency department of The Ottawa Hospital with an abscess less than 5 cm diameter, as judged by the attending emergency physician (measurement with tape measure for diameter) between the hours of 7 am and 10 pm will be approached for possible enrollment. Ultrasound will be used to assess the appropriate
Exclusion criteria: .


Association of Velcade to R-CHOP in the Treatment of B Cell Lymphoma

Summary: The primary objective of this study is to evaluate the response rate and toxicity of the association R-CHOP with two schedules of administration of Velcade, in B-cell CD 20 + lymphoma patients, aged from 18 to 80 years~The goal is to get a response rate at least at what observed with R-CHOP alone and will be evaluates with a sequential test.~The other objective is to evaluate the toxicity
Inclusion criteria: inclusion criteria:

 • Patients with one of the following B-cell Lymphoma CD 20 positive : Mantle cell, Marginal zone, lymphocytic, follicular requiring treatment, Histological transformation from low grade to high grade, diffuse large cell without adverse prognostic factors defined by the international prognostic index (IPI)

 Aged from 18 to 80 years

 Untreated with chemotherapy except with Chlorambucil or Cyclophosphamide per os alone less than 6 months

 Previous radiotherapy except if localized

 Performance status < 3

 Signed inform consent

Exclusion criteria: :

 Other type of lymphomas: Burkitt, T cell, CD 20 negative

 Central nervous system or meningeal involvement

 Contraindication to any drug contained in the chemotherapy regimen

 HIV disease, active hepatitis B or C

 Treatment with polychemotherapy before except with Chlorambucil or Cyclophosphamide per os less than 6 months

 Prior extended radiotherapy

 Any serious active disease or co-morbid medical condition (according to investigator's decision )

 Renal deficiency (clearance < 30 ml/mn), liver deficiency (bilirubin > 30 mmol/l) unless related to lymphoma

 Neuropathy> grade 2 within 14 days before enrollment

 Platelets < 30.109/l within 14 days before enrollment

 Neutrophils < 1.0 109/l within 14 days before enrollment

 Women with pregnancy or without adequate method of contraception

 Any history of active cancer during the last two years


A Placebo-Controlled, Double-Blinded, Randomized Trial of Remicade in Korean Patients With Rheumatoid Arthritis Despite Methotrexate (Study P04280)(COMPLETED)

Summary: Prior to the first infusion, patients will be randomized into one of two groups (placebo or infliximab). All patients will continue to receive the same does of methotrexate (MTX) during the study as received prior to the study. The objective of the study is to evaluate the efficacy and safety result of infliximab with Korean patients in reducing clinical signs and symptoms of rheumatoid arthritis (RA) at 30 weeks following the onset of treatment and to review whether the result is comparable to the result of the ATTRACT trial.
Inclusion criteria: inclusion criteria:

 Diagnosis of RA according to the revised 1987 criteria of the American Rheumatism Association (Arnett et al, 1988). The disease should have been diagnosed at least 6 months prior to screening.

 Active disease at the time of screening and pre-infusion as defined by:

 >=6 swollen joints

 >=6 tender joints and 2 of the following:

 morning stiffness >=45 min

 ESR >=28 mm/h

 CRP >=20 mg/L

 Men and women, >=18 to <=75 years of age

 Men and women of childbearing potential must be using adequate birth control measures (abstinence, oral contraceptives, IUD, barrier method with spermicide or, surgical sterilization) and should continue such precautions for 6 months after receiving the last infusion.

 Patients must have been using oral or parenteral MTX for at least 3 months with no break(s) in treatment of more than 2 weeks total during this period. Patients must have been on a stable dose of >=12.5 mg/wk (maximum 20mg/wk) for at least 4 weeks prior to screening.

 Patients must be on a stable dose of folic acid prophylaxis for at least 4 weeks prior to screening.

 Patients using oral corticosteroids, must have been on a stable dose of <=10 mg/day for at least 4 weeks prior to screening. If currently not using corticosteroids the patient must have not received corticosteroids for at least 4 weeks prior to screening.

 If using NSAIDs, patients should have been on a stable dose for at least 4 weeks prior to screening. If currently not using NSAIDs the patient must have been off for at least 4 weeks prior to screening.

 The screening laboratory tests must meet the following criteria:

 Hemoglobin >=5.3 mmol/L (>=8.5 g/dL), providing a low hemoglobin level is not due to nutritional deficiencies or due to diseases other than chronic RA

 WBC >=3.5 x 10^9/L

 Neutrophils >=1.5 x 10^9/L

 Platelets >=100 x 10^9/L

 Serum transaminase <=2 times the upper limit of normal

 Alkaline phosphatase levels <=2 times the upper limit of normal

 Serum creatinine <=150 µmol/L (<=1.7 mg/dL)

 Patient must be able to adhere to the study visit schedule and other protocol requirements.

 Patient must be capable of giving informed consent and the consent must have been obtained prior to any study procedures including wash-out period.

Exclusion criteria: :

 Pregnant women, nursing mothers or a planned pregnancy within 1.5 years of enrollment.

 Patients who are incapacitated, largely or wholly bedridden or confined to a wheelchair, and who have little or no ability for self-care.

 Patients who have any current systemic inflammatory condition with signs and symptoms that might confound the evaluations of benefit from the Infliximab therapy, eg Lyme disease, or a rheumatic disease other than RA.

 Use of DMARDs other than MTX within 4 weeks prior to screening. (If a patient had prior exposure to leflunomide within the past 6 months, cholestyramine 8 g should be given 3 times daily for 11 days to rapidly lower the plasma level of leflunomide.)

 Use of intra-articular, i.m. or i.v. corticosteroids (including i.m. ACTH) within 4 weeks prior to screening.

 Have been previously treated with infliximab or genetic recombinant therapy with RA (e.g. etanercept, adalimumab).

 Treatment with any other therapeutic agent targeted at reducing TNF (eg, pentoxifylline or thalidomide) within the previous 3 months.

 Treatment with any investigational drug within the previous 3 months.

 Prior use of cyclophosphamide, nitrogen mustard, chlorambucil, or other alkylating agents.

 Have a history of any clinically significant adverse reaction to murine or chimeric proteins, including but not limited to allergic reactions.

 History of infected joint prosthesis within previous 5 years.

 Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months.

 Chronic infectious disease such as chronic renal infection, chronic chest infection with bronchiectasis or sinusitis.

 Have active TB. Also excluded are patients who have evidence of latent TB (positive PPD skin test or a history of latent TB) without adequate therapy for TB initiated prior to first infusion of study drug. Also excluded are patients with evidence of an old or latent TB infection without documented adequate therapy, if they will not be treated with antitubercular therapy during the trial. Patients with a current close contact with an individual with active TB will also be excluded. Additionally, patients who have completed treatment for active TB within the previous 2 years are now explicitly excluded from the trial. Patients with a household member who has a history of active pulmonary TB should have had a thorough evaluation for TB prior to study enrollment as recommended by a local infectious disease specialist or published local guidelines of TB control agencies. Also excluded are patients with opportunistic infections, including but not limited to evidence of active cytomegalovirus, active Pneumocystis carinii, aspergillosis, or atypical mycobacterial infection, etc, within the previous 6 months.

 Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease.

 History of lymphoproliferative disease including lymphoma or signs suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic areas), or splenomegaly.

 Any current known malignancy or history of malignancy within the previous 5 years, except for squamous or basal cell carcinoma of the skin that have been treated with no evidence of recurrence.

 Patients with moderate or severe heart failure (NYHA class III/IV)

 Patients with pre-existing or recent onset of central nervous system demyelinating disorders

 Known recent substance abuse (drug or alcohol).

 Patients in whom multiple venipunctures are not feasible due to poor tolerability or lack of easy access.

 Have a known infection with HIV or known active hepatitis B/C infection (including associated chronic active hepatitis).


Perforated Appendicitis With Delayed Presentation

Summary: There is no consensus among pediatric surgeons regarding the optimal treatment for children with complicated appendicitis with delayed diagnosis. With the development of broad-spectrum antibiotics, some surgeons have advocated expectant management for these children. However, there is little evidence to determine which children are most likely to benefit from this approach. Prior attempts to determine the effectiveness of expectant management for perforated appendicitis with delayed diagnosis often have not controlled for inherent differences in the clinical status of patients treated non-operatively vs. those treated with immediate appendectomy.
Inclusion criteria: inclusion criteria:

 All children with a delayed diagnosis of perforated appendicitis. Delayed diagnosis will be defined as symptoms for 4 or more days. Duration of symptoms will be defined as the time pain started.

 Confirmed diagnosis of perforated appendicitis. The diagnosis of perforated appendicitis will be based on diagnostic imaging (CT scan or ultrasound), showing an established appendiceal abscess or phlegmon.

 Consent to participate

Exclusion criteria: :

 Uncertainty about the diagnosis.

 The need for laparotomy for another reason.

 Free intraperitoneal air on imaging.

 Perforated appendicitis with diffuse abdominal fluid on imaging associated with a clinical picture of severe sepsis.

 Children with other medical condition that may affect the decision to operate e.g: children with inflammatory bowel disease.

['Laparoscopic or open appendectomy', 'Expectant Management']

Laparoscopic or open appendectomy
Expectant Management


Non-Healing Ulcers Without Critical Limb Ischemia

Summary: Background: Lower limb arterial revascularization procedures, either percutaneously or surgically performed, are an established treatment modality of ischemic foot ulcers, especially in the setting of a critical limb ischemia. Many other lower limb ulcers are secondary to a combined disease, which may include a concomitant venous disease (chronic venous insufficiency or varicous disease) or a micro-angiopathic disease (i.e. small vessel disease). In this setting, and especially in the absence of a concomitant severe macro-angiopathic disease, the safety and efficacy of a percutaneous lower limb revascularization have so far never been evaluated in a prospective study.~Aim: This study is aimed to evaluate the safety and the efficacy of an endovascular revascularization approach of the lower limb, in all consecutive patients presenting with a non-healing ulcer associated with a mild to moderate peripheral artery disease (i.e. mixed-origin ulcers).~Material and methods: This prospective study will consecutively include all patients presenting with a non-healing ulcer. Included patients must have all the concomitant ulcer co-factors being adequately treated for at least 6 months. Accordingly, an underlying venous disease, infectious disease or inflammatory disorder must be previously evaluated and adequately treated (i.e. compression stocking, varices stripping, antibiotics, local ± systemic anti-inflammatory, etc.). Furthermore, a non-invasive arterial evaluation must be obtained in all patients. The arterial screening must included an ankle-brachial index (ABI) and toe pressure (TP) measurements, a trans-cutaneous oxygen measurement (tcPO2) at the foot and calf levels and a non-invasive arterial mapping (i.e. angio-CT or angio-MRI). This arterial work-up must be compatible with the presence of a mild to moderate peripheral artery disease without any sign or criteria suggesting the presence of a critical limb ischemia.~End-points: The success rate of perform an endovascular revascularization intervention in all consecutive patients which qualify according to the inclusion criteria (technical feasibility). Establish the proportion of procedural related complications (safety). Analyze the clinical and the para-clinical improvements in term of heal of the ulcers, as well as the improvement of the ABI, TP, tcPO2 at 1 week, 1-3-6 months after the procedure (efficacy).~Sample size: The investigators plan to include ≈ 30 patients in two years. After 1 year of enrollment the investigators will perform an interim analysis and will decide at that moment, according to the observed end-points, if prolonging the study would be of any scientific value or if the study has to be interrupt earlier because of a significant improvement of all already treated ulcers.
Inclusion criteria: inclusion criteria:

 Patients need to be at least 18 years old

 Patients have to be admitted to the university hospitals of Geneva for a non-healing lower limb ulcer.

 - Eligible patients are those presenting with non-healing lower limb ulcers for more than 3 months.

 Patients will be hospitalized in the Dermatology inpatient clinic.

 Patients had to benefit from at least one thin skin autograft at the ulcer level in the past or during the index hospitalization.

 Before inclusion in the study, patients must undergo complete angiological diagnostic work-up including:

 A baseline ABI, toe pressure and tcPO2 measurements,

 A non-invasive arterial imaging including an angio-CT scan or an angio-MRI,

 The non-invasive arterial work-up must revel mild to moderate PAD, without any criteria or sign of CLI (see flow-chart):

 Ankle pressure ≥ 50 mmHg,

 + ABI: < 0.9 or > 1.3,

 ± Toe pressure : 30-100 mmHg

 ± tcPO2: 20-40 mmHg,

 At this moment the patient may be included in the study protocol.

 All patients presenting with mild to moderate PAD and evidence of at least 1 impaired arterial vessel targeting the ulcer will initially undergo conservative impatient clinic care for at least 2-4 weeks and benefit from at least 1 thin skin autograft.

 Persisting surface of lower limb ulcers will be assessed 1 month later:

 -- In the presence of a healed ulcer surface > 70%, the patient will undergo 6 months of clinical follow up at 1-3-6 months.

 1. In case of persistence of healed ulcer surface > 70% clinical success will be achieved.

 2. In presence of healed ulcer surface < 70% the patient will undergo a new angiological work-up.

 If mild to moderate PAD will be again outlined the patient will join the < 70% healed ulcer group.

 On the other hand, if CLI will be pointed out lower limb revascularisation and at least one thin skin autograft will be performed.

 -- In presence of a healed ulcer surface < 70%, endovascular PTA and at least one thin skin autograft will be performed. The ulcers healing will then be monitored at 1-3-6 months and persisting ulcers surface re-assessed:

 in presence of an healed ulcer surface > 70% clinical success will be achieved,

 if presence of an healed ulcer surface < 70% clinical failure will be retained.

Exclusion criteria: :

 Patients who refused to give their written informed consent.

 Patients, in whom the angiological work-up shows the presence of a CLI, mandating a revascularization procedure attempt (i.e. ankle pressure < 50mmHg, toe pressure < 30mmHg, tcPO2 < 20mmHg) (see particular situation n°2).

 Patients who do not present with peripheral artery disease (i.e., ABI > 0.9 - < 1.3, TP > 100mmHg, tcPO2 > 40mmHg).

 Patients in whom the angiological-dermatological work-up shows the presence of another reversible cause of the non-healing ulcer:

 - Special attention will be given to the presence of a treatable venous insufficiency (e.g. compression stocking, varices stripping), an underlying inflammatory/infectious process (treatable with antibiotics or topic-systemic antiinflammatory medications) or other reversible mechanical factors (unadapted shoes, etc.).

 Patients without any significant lesion of the arterial tree (ilio-femoro-popliteal and infra-popliteal):

 - In case there will be a single BTK vessel disease not perfusing the ulcer area (e.g. pre-tibial ulcer with a significant stenosis of the posterior tibial artery which does not perfuse the ulcer region), the patient will not be included in the study because any significant ulcer improvement would be expected from this non-target vessel revascularization.

 Patients in whom the scheduled revascularization procedure will be judged too risky for the patient's safety:

 Chronic kidney failure (= Creatinin Clearance < 20ml/min) with an increased risk of contrast induced nephropathy,

 Too complex arterial disease or anatomy, in which the estimated procedural technical success rate is < 50% (i.e. complex chronic total occlusion).

 Patients in whom an amputation is unavoidable, despite any revascularization attempt (e.g. extensive skin necrosis [Rutherford class 6]), - If, it will be estimated that, a successful revascularization procedure may reduce the level of amputation, or if a successful intervention may improve the amputation's healing process, the patient may be included in the study.

['Angioplasty of the lower limbs vessels']

['Peripheral Artery Disease Without Critical Limb Ischemia']


Acupuncture for Shortness of Breath in Cancer Patients

Summary: The purpose of this study is to determine whether acupuncture is effective in relieving shortness of breath among breast and lung cancer patients.
Inclusion criteria: inclusion criteria:

 Diagnosis of local or metastatic breast or lung cancer

 Shortness of breath with onset after cancer diagnosis

 Life expectancy of at least 4 weeks

Exclusion criteria: :

 Prior acupuncture

 Other conditions suspected of causing shortness of breath, such as congestive heart failure, sarcoid disease, pneumonia, or obesity

 No chest wall deformity

 Neuromuscular disorders

 Pulmonary vascular disease

 Anemia

 Uncontrolled pain or infection

 Heart valve dysfunction


Recombinant Measles Virus Vaccine Therapy and Oncolytic Virus Therapy in Treating Patients With Progressive, Recurrent, or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Summary: RATIONALE: A gene-modified virus may be able to kill tumor cells without damaging normal cells.~PURPOSE: This phase I trial is studying the side effects and best dose of an attenuated oncolytic measles virus therapy and oncolytic virus therapy in treating patients with progressive, recurrent, or refractory ovarian epithelial cancer or primary peritoneal cancer (measles virus vaccine therapy study closed as of 06/02/2008).
Inclusion criteria: inclusion criteria:

 Age ≥ 18 years.

 Must have persistent, recurrent or progressive ovarian cancer or primary peritoneal cancer after prior treatment with platinum and taxol compounds. Histologic confirmation of the original primary tumor is required. Prior bilateral oophorectomy is required.

 Patients with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometroid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma NOS

 The following laboratory values obtained ≤7 days prior to registration:

 ANC ≥ 1500/μL

 PLT ≥ 100,000/μL

 Total bilirubin ≤ upper normal limit

 AST ≤ 2 x ULN

 Creatinine ≤ 1.5 x ULN

 Hgb ≥ 9.0 g/dL

 Ability to provide informed consent.

 Willingness to return to Mayo Clinic Rochester for follow-up.

 Life expectancy ≥ 12 weeks.

 Must have anti-measles immunity as demonstrated by serum IgG anti-measles antibody levels of ≥ 20.0 EU/ml as determined by Enzyme Immunoassay (Diamedix, FL).

 Must have normal serum CEA levels (<5 mg/ml) both at the time of study entry and in any prior testing. (NOTE: Not applicable for the MV-NIS cohort.)

 Willingness to provide all biologic specimens as required by the protocol.

 Measurable disease by exam or CT scan, or, for patients with CA-125 elevation or with microscopic residual but without measurable disease on imaging, willingness to undergo laparoscopy for evaluation of treatment effect if no radiographic progression after 6 treatment cycles.

 CD4 count ≥200/μL or ≥15% of peripheral blood lymphocytes

Exclusion criteria: :

 Epithelial tumors of low malignant potential, stromal tumors, and germ cell tumors of the ovary.

 Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy. Subjects will be excluded if this is their first relapse and they have recurred >6 mo from completion of primary (adjuvant) chemotherapy.

 ECOG performance status (PS) 3 or 4.

 Active infection ≤5 days prior to registration.

 History of tuberculosis or history of PPD positivity.

 History of other malignancy ≤5 years except for non-melanoma skin cancer or carcinoma in situ of the cervix.

 Any of the following prior therapies:

 Chemotherapy ≤ 3 weeks prior to study entry

 Immunotherapy ≤ 4 weeks prior to study entry

 Biologic therapy ≤ 4 weeks prior to study entry

 Extensive abdominal surgery if it includes enterotomy(ies) <3 weeks prior to study entry. This criterion does not apply to placement of the peritoneal port-a-cath or lysis of adhesions at the time of study entry.

 Any viral or gene therapy prior to study entry

 Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment.

 New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias (atrial fibrillation or SVT).

 Requiring blood product support.

 CNS metastases or seizure disorder.

 HIV-positive test result, or history of other immunodeficiency.

 History of organ transplantation.

 History of chronic hepatitis B or C.

 Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation).

 Any concurrent medications which could interfere with the trial.

 Intra-abdominal disease > 8 cm in diameter at the time of registration, intrahepatic disease, or disease beyond the abdominal cavity.

 Treatment with oral/systemic corticosteroids, with the exception of topical or inhaled steroids.

 Exposure to household contacts ≤15 months old or household contact with known immunodeficiency.

 Allergy to measles vaccine or history of severe reaction to prior measles vaccination.

 Allergy to iodine. This does not include reactions to intravenous contrast materials.

['carcinoembryonic antigen-expressing measles virus', 'oncolytic measles virus encoding thyroidal sodium iodide symporter', 'reverse transcriptase-polymerase chain reaction', 'laboratory biomarker analysis']

['Ovarian Cancer', 'Primary Peritoneal Cavity Cancer']

Ovarian Cancer
Primary Peritoneal Cavity Cancer


Follow-up the Health Condition , Investigation of the Immuno-regulation , and the Study for Interaction of Viral Hepatitis--- Among Patients With or After Dengue Fever Infection

Summary: Originally test host's to understand the tracking healthily and immune change of the dengue fever in Taiwan. Blood drawing 20 c.c for liver examination, kidney and other biochemical function, analyze host immunity adjusts and controls the gene, and the reciprocation that may be produced with the virus hepatitis, besides collected 10 c.c urine at the same time. Urine check is in order to compare acute infect and infected over three month person, the change of chemical composition.~This plan expect to collect 150 healthy, 150 dengue fever infected and 150 dengue fever bleed hot or dengue fever shock disease group's patient, goal to understand health state and immunity of follow-up adjust and control the difference of the gene and the reciprocation may produce to virus hepatitis of light disease and serious disease.
Inclusion criteria: inclusion criteria:

 Clinical diagnosis of Dengue Fever
Exclusion criteria:


Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection

Summary: Antibiotics are currently required to treat patients in hospital when they have an infection, but these antibiotics can cause side effects such as diarrhoea and in some patients a serious form of gut infection with an organism called Clostridium difficile. This organism can produce toxins in the gut causing a severe form of diarrhoea associated with a lot of ill health, and in some circumstances can be fatal. Some studies have shown that yogurts' or Probiotics' (special drinks with a defined concentration of useful bacteria) taken by patients can have a beneficial effect in reducing the diarrhoea associated with antibiotics use. The aim of the present study is to find out whether the use of one of these Probiotics in hospitalised patients taking antibiotics will result in less diarrhoea, less Clostridium difficile infection, as well as cost saving. The study will also analyze the effects of probiotics on quality of life and length of hospital stay.
Inclusion criteria: inclusion criteria:

 Male/female patients, above 55 years of age Patient has given written informed consent/Assent to take part in the study Patients are receiving antibiotics as inpatients Patients prescribed therapy with single or multiple antibiotics (oral or IV) will be included Antibiotic therapy must be indicated for a minimum of 72 hours Patients must be able to take medication orally Inclusion in the study is approved by the admitting consultant and validated by a member of the trial team within 48 hours

Exclusion criteria: :

 Age less than 55 years Pregnancy Patients on PEG feed. Diarrhoea on admission or within the preceding week Severe life-threatening illness

 Subjects with allergy or hypersensitivity to any component of the study product (e.g.: allergy or hypersensitivity to milk proteins) Subjects who had any surgery or intervention in the last 4 weeks Subjects enrolled in another clinical study in the last 4 weeks Subjects who are thought not to comply with the clinical study Subjects presenting with a severe evolving or active pathology or infection of the gastrointestinal tract such as inflammatory bowel disease, Crohn's disease or ulcerative colitis, diverticular disease or liver cirrhosis.

 Any condition affecting the pancreas including acute and chronic pancreatitis Patients who had a surgical operation in their bowels in the preceding 3 months A medical condition such that the life expectancy of the patient is predicted at less than 3 months by the admitting consultant and validated by a member of the trial team Immune-suppressed patients (e.g. HIV) Steroid use of Prednisolone greater than 10mg a day (or equivalent of Dexamethasone) for over 2 weeks prior to entering the trial Patients on Cytotoxic drugs Post-transplant patients Any clinical condition affecting the pancreas including acute and chronic pancreatitis Patients with prosthetic heart valves or a history of endocarditis. Patients who have taken probiotic drinks containing live organisms or over the counter probiotic preparations in the past seven days (see Appendix 10) Foreign travel in the last 7 days

['Probiotic drink containing the live strain', 'placebo probiotic']


An Observational Post-Authorization Safety Specialist Cohort Event Monitoring Study (SCEM) to Monitor the Safety and Utilization of Rivaroxaban (Xarelto®).

Summary: This study aims to evaluate the use of rivaroxaban and its short term safety when used by patients for the new indications of prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE. Any adult patient started by their care team on rivaroxaban or an alternative anticoagulant for the specified indications during the study period will be eligible to take part. A questionnaire will be completed by the care team of each patient at the start of treatment and again 12 weeks later. The care team will complete the questionnaires using information from the patient's medical notes, not by asking the patient directly. If a participant has an adverse event during the 12 week period, we may ask the patient's care team to fill out a further follow up questionnaire. No other examinations or tests will be performed. Patients will only be recruited to the study after the clinical decision to prescribe rivaroxaban or an alternative anticoagulant has been made, so that prescribing behaviour is not altered by the study. It is an observational, non-interventional study covering the whole of England and Wales.
Inclusion criteria: inclusion criteria:

 age 18 years or above after study start

 index date on or after study start

 signed, informed consent

 patients treated for DVT or PE

 patients with non-valvular AF (with one or more risk factors) treated for prevention of stroke and systemic embolism

Exclusion criteria: :

 any use of univalent direct thrombin inhibitor or direct factor Xa inhibitors

 use of anticoagulant therapy or other vitamin K antagonists recorded within one year prior to index date

['Atrial Fibrillation', 'Deep Vein Thrombosis', 'Pulmonary Embolism']

Atrial Fibrillation
Deep Vein Thrombosis
Pulmonary Embolism


Levetiracetam as add-on Treatment of Myoclonic Jerks in Adolescents + Adults

Summary: A double-blind, placebo-controlled study to assess the efficacy of adjunctive treatment with LEV 3000mg/day in reducing myoclonic seizures in adolescents and adults suffering from idiopathic generalised epilepsy and to evaluate the safety of LEV in the same population.
Inclusion criteria: inclusion criteria:

 Subjects with a confirmed diagnosis consistent with idiopathic generalized epilepsy experiencing myoclonic seizures (IIB) that are classifiable according to the International Classification of Epileptic Seizures. To ensure an idiopathic generalized epilepsy population, only these subjects with the diagnosis of juvenile myoclonic epilepsy (JME), juvenile absence epilepsy (JAE) or epilepsy with generalized tonic- clonic seizures on awakening must be included.

 Presence of at least eight days with at least one myoclonic seizure (IIB) per day during the eight weeks of the Baseline period.

 Absence of brain lesion documented on a CT scan or MRI; if a CT scan or MRI has not been performed within the past five years before Visit 1, a CT scan (or MRI where legally required) should be performed during the Baseline period.

 Presence of EEG features consistent with idiopathic generalized epilepsy on an EEG recorded during the Baseline period or no more than one year before Visit 1.

 Male/female children ≥ 12 years of age or adult ≤ 65 years of age at Visit 1.

 Subject on a stable dose of one standard anti-epileptic treatment for at least four weeks before Visit 1.

Exclusion criteria: :

 Previous exposure to levetiracetam.

 History of partial seizures.

 History of convulsive or non-convulsive status epilepticus within 3 months prior to Visit 1.

 Subject taking vigabatrin or tiagabine, subject on felbamate with less than 18 months exposure, and subject under vagal nerve stimulation or ketogenic diet.

 Subject taking any drug (except the concomitant AEDs) with possible CNS effects.


Xylitol for Caries Prevention in Inner-City Children

Summary: The purposes of this study is to determine whether xylitol use in kindergarten school children in addition to oral health education, provision of tooth brush and fluoride paste, fluoride varnish and sealant treatment will reduce decay in the first permanent molars and other permanent teeth.
Inclusion criteria: inclusion criteria:

 attending kindergarten in one of the participating schools

 must have parental permission

Exclusion criteria: :

 children with severe stomach illness (ex. Crohn's disease, ulcerative colitis, Celiac disease, irritable bowel syndrome, etc.)

 children with strict dietary restriction (ex. Diabetes)

['Xylitol gummy bears', 'Sugar free fiber gummy bears', 'Oral health education', 'Fluoride varnish', 'Dental sealant']

Xylitol gummy bears
Sugar free fiber gummy bears
Oral health education
Fluoride varnish
Dental sealant


Intravenous Immunoglobulin for PANDAS

Summary: Background:~- Some children experience a sudden onset of symptoms similar to those found in obsessive-compulsive disorder that may be caused by the body s reaction to an infection with streptococcal bacteria, most commonly seen as strep throat or scarlet fever. When the body s immune system reacts against brain cells following a streptococcal infection, the condition is known as PANDAS (pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections). The immune system response can be inactivated by treatment with a drug known as intravenous immunoglobulin (IVIG). Because there is insufficient research on IVIG s effects on the immune system of children with PANDAS, including whether IVIG is helpful in treating obsessive-compulsive symptoms related to PANDAS, researchers are interested in examining whether IVIG is an appropriate treatment for PANDAS and its associated symptoms.~Objectives:~- To test the safety and effectiveness of intravenous immunoglobulin for the treatment of obsessive-compulsive disorder in children with PANDAS (pediatric autoimmune neuropsychiatric disorder associated with streptococcal infection).~Eligibility:~- Children between 4 and 12 years of age who have obsessive-compulsive disorder (with or without a tic disorder) with sudden onset of symptoms following Group A streptococcal bacterial infections.~Design:~Participants will be screened by telephone to obtain medical history and other information, followed by in-person screening at the National Institutes of Health Clinical Center.~Participants will be admitted to the hospital to receive 2 days of infusions of either IVIG or a placebo. Frequent blood samples, imaging studies, and other tests will be performed during this visit.~Six weeks after the inpatient stay, participants will return for further blood samples and other tests. Participants who did not receive the study drug, or who received the drug but did not respond to the initial IVIG infusion, will have the option to receive IVIG at this time.~Followup visits will take place 3 months and 6 months after the first evaluation, followed by yearly follow-ups for 5 additional years.
Inclusion criteria: inclusion criteria:

 Male and female children 4-13 years of age.

 Presence of (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision) DSM-IV TR OCD with or without a tic disorder.

 Moderate or greater severity of symptoms, with a score of greater than or equal to 20 on the Children s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) and greater than or equal to 4 on the Clinical Global Impression Severity scale (CGI-S).

 The acute onset within the previous six months of symptoms in a child previously well, or the first acute recurrence within the previous six months, after a period of relatively complete remission of symptoms. The acuity of symptom onset/exacerbation is key and must be severe, dramatic in onset, and proceed from no/minimal symptoms to maximum severity within 24-48 hours.

 Symptom onset or first exacerbation preceded within four months by a GAS infection, as documented by positive throat culture, exposure to documented GAS infection (in a close contact, such as a sibling sharing a bedroom), and/or documented two-fold rise in one or more anti-GAS antibody titers such as anti-streptolysin O, anti-streptococcal DNAaseB, anti-carbohydrate antibodies and others.

 Onset/exacerbation of OCD is accompanied by at least three of the following 7 clinical signs and symptoms. The acuity of the comorbid symptoms must be similar to the OCD symptoms and occur in the same time interval.

 Markedly increased level of anxiety, particularly new onset of separation anxiety.

 Emotional lability, irritability, aggressive behavior and/or personality change.

 Sudden difficulties with concentration or learning.

 Developmental regression (baby-talk, temper tantrums; behaviors atypical for actual chronological age).

 Sleep disorder (insomnia, night terrors, refusal to sleep alone).

 Handwriting deterioration or other sign of motoric dysfunction (including new onset of motor hyperactivity, or presence of choreiform finger movements).

 Urinary frequency or increased urge to urinate; daytime or night-time secondary enuresis.

Exclusion criteria: :

 History of rheumatic fever, including Sydenham chorea (the neurologic manifestation).

 Presence of symptoms consistent with autism, schizophrenia, or other psychotic disorder (unless psychotic symptoms have onset coincident with the possible PANDAS and are attributed to OCD).

 Presence of a neurological disorder other than a tic disorder.

 IQ <70. Child subjects need to be able to contribute meaningfully to baseline and follow-up ratings, to report adverse effects, and to assent to participation.

 Presence of serious or unstable medical illness or psychiatric or behavioral symptoms that would make participation unsafe or study procedures too difficult to tolerate.

 IgA deficiency (<20mg/dL). Intravenous immunoglobulin may contain trace IgA, which may very rarely lead to life-threatening anaphylaxis in IgA-deficient participants with anti-IgA antibodies (Misbah 1993).

 Hyperviscosity syndromes, which can increase risks associated with IVIG administration.

 Need for live virus vaccine within six months after receiving IVIG (which may be 7.5 months from randomization) since IVIG can interfere with effectiveness of such vaccines. IVIG should not be administered sooner than two weeks after administration of a live virus vaccine, for the same reason.

 Taking nephrotoxic drugs. Every concomitant medication will be subject to scrutiny and possible consultation with pediatric safety monitors before randomization to study drug. See below as well.

 Recent (less than eight weeks) initiation of cognitive-behavior therapy (CBT).

 Recent (less than eight weeks) initiation or change in dosage of psychotropic medication for OCD or tic disorder (e.g., serotonin reuptake inhibitors for OCD, alpha-2 agonists or antipsychotics for tic disorders).

['Gamunex Intravenous Immunoglobulin', 'Placebo']

Gamunex Intravenous Immunoglobulin
Placebo

['Obsessive-Compulsive Disorder', 'Children', 'Anxiety Disorder', 'Autoimmune Disease', 'PANDAS']

Obsessive-Compulsive Disorder
Children
Anxiety Disorder
Autoimmune Disease
PANDAS


Sleep Disorders in Children With ADHD

Summary: ADHD is often associated with sleep difficulties. Attention-deficit/hyperactivity disorder (ADHD) is the most common problem presented to children mental health services. The disorder affects approximately 5 % of school-age children. The core symptoms of this disorder include varying degrees of inattention, impulsiveness and restlessness.~In addition to the core symptoms, ADHD is associated with other problems (e.g. academic underachievement, poor social relations and sleep disturbances).~Despite clinical observations of sleep problems in children with ADHD, there is little empirical research on this topic. The prevalence, type of sleep problems, and significance of these sleep disturbances in children with ADHD remain undocumented.~The objective is to determine the relationship of sleep problems to attention deficit/hyperactive disorder, comorbid disorders, and the effect of stimulant treatment.
Inclusion criteria: inclusion criteria:

 - We will compare a group of children with ADHD, other psychiatric disorder, and a healthy group of children age 5 - 10

Exclusion criteria: :

 mental retardation -

['Attention Disorder With Hyperactivity (ADHD)']


A Safety, Tolerability and Pharmacokinetic Study of Two Formulations of Metronidazole Versus Immediate Release Metronidazole in Patient With C. Difficile Colitis

Summary: Clostridium difficile bacteria can be a cause of significant diarrheal disease, particularly in people who have taken potent antibiotics. When C. difficile multiplies within the colon, it produces two toxins that cause inflammation and resultant abdominal pain, fever and diarrhea. Current treatment of mild to moderate disease is with immediate release metronidazole, an antibiotic that kills C. difficile. Dr. Reddy's Laboratories has developed a delayed release form of metronidazole to release just before the colon to increase the concentration of antibiotic in the colon to improve the effectiveness of metronidazole treatment and potentially to allow less whole body exposure to the antibiotic.~This study will measure the amount of metronidazole in the blood and stool of patients with C. difficile associated diarrhea (CDAD) to confirm that the new formulations are releasing the antibiotic as designed, immediately before the colon.
Inclusion criteria: inclusion criteria:

 Male and female patients 18 years of age or older

 Mild to moderate C.difficile associated diarrhea (CDAD) with a positive stool C.difficile toxin (by ELISA).

 Either a first episode of CDAD or a first recurrence (patients with more than 1 recurrence are not eligible)

 Greater than 3 watery or unformed bowel movements in the prior 24 hours

 Females of child bearing potential having a negative pregnancy test and taking adequate birth control measures.

 Patients should not consume alcohol at least 12 hours prior to dosing (i.e. in-house monitoring) and until 48 hours after the last dose of drug administration (until Day 14).

 Able to comprehend and give informed consent for the study and able to adhere to study schedules and protocol requirements.

Exclusion criteria: :

 Known prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives

 Life expectancy ≤ 60 days

 Sepsis, severe sepsis, or septic shock

 Signs or symptoms of peritonitis, megacolon or ileus

 History of ulcerative colitis or Crohn's disease

 Oral or parenteral antibiotic therapy with metronidazole or vancomycin or other drugs effective in treating DCAD (e.g., bacitracin, fusidic acid) within the 1 week prior to enrollment

 Recent history of significant drug or alcohol abuse within 1 year

 Any findings on physical examination, medical history, 12-lead ECG or clinical laboratory tests which, in the judgment of the Principal Investigator, would exclude patients from participating in the study

 Patients with history of blood dyscrasias, porphyria and active non-infectious disease of the central nervous system

 Patients with history of rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption

 Pregnant or lactating female patients

 Participation within 30 days before the start of this study in any experimental drug or device study, or currently participating in a study in which the administration of investigational drug or device within 60 days is anticipated

 Unable to participate in the study for any reason in the opinion of the Principal Investigator

['Clostridium Difficile Associated Diarrhea']


Improving Blood Pressure Management in Patients With Diabetes

Summary: About 22% of Canadians have high blood pressure, or hypertension. However, studies have shown that only 1 out of 5 people with hypertension have their blood pressure controlled.~Diabetes is also an important risk factor for heart disease and stroke. About half of people with diabetes also have hypertension - a deadly combination. Studies have shown that only about 1 in 10 people with diabetes have their blood pressure controlled adequately - clearly something needs to be done to improve this.~Heart disease, stroke, hypertension, and diabetes are conditions that occur in the community, so we need to explore innovative solutions that will work in the community. Pharmacists are well-placed in the community to help identify people with diabetes and hypertension. This has worked very well in previous studies in patients with high cholesterol levels. Pharmacists and nurses have complementary skills which, when working as a team, may help identify and better manage hypertension in people with diabetes.~Our main objective is to test whether a community pharmacist and nurse team can improve blood pressure control in people with diabetes and hypertension.
Inclusion criteria: inclusion criteria:

 The following patients will be eligible for study participation:

 Patients with either type 1 or type 2 diabetes. Diabetes will be defined as those patients presently taking either oral hypoglycemic agents or insulin therapy (oral hypoglycemic agents to include all drugs in the drug classes of: alpha-glucosidase inhibitors, biguanides, meglitinides, sulfonylureas, thiazolidinediones and adjunctive therapy) taken for >6 months to rule-out steroid-induced diabetes and gestational diabetes.

Exclusion criteria: :

 Patients will be excluded from the study if they:

 Do not provide or are unable to provide written informed consent

 Refuse or are unlikely to attend follow-up visits for BP measurements

 Are institutionalized

 Are <18 years of age

 Do not understand English

 Enrolled in other diabetes or hypertension trials

 Subjects will be recruited whether or not they are receiving antihypertensive therapy.

['Lifestyle Counselling; Opinion Leader Influence Statements']

['Hypertension', 'Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2']

Hypertension
Diabetes Mellitus
Type 1
Diabetes Mellitus
Type 2


Etanercept in Kawasaki Disease

Summary: The purpose of this study is to determine whether Etanercept (Enbrel) when used in conjunction with IVIG and aspirin, improves treatment response to IVIG in patients with Kawasaki Disease. Funding Source- FDA/OOPD
Inclusion criteria: inclusion criteria:

 Male Age 2 months to 20 years of age Female Age 2 months to 11 years of age

 Provision of Parental Consent

 Kawasaki Disease Presentation

Exclusion criteria: :

 Laboratory Criteria: Any laboratory toxicity, at the time of the screening visit or at any time during the study that in the opinion of the Investigator would preclude participation in the study or:

 Platelet count < 100,000/mm3

 WBC count < 3,000 cells/mm3

 Hemoglobin, hematocrit, or red blood cell count outside 30% of the upper or lower limits of normal for the Lab

 Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit.

 Female subjects diagnosed with KD 12 years of age and older.

 Subjects who have known hypersensitivity to Enbrel or any of its components or who is known to have antibodies to etanercept

 Prior or concurrent cyclophosphamide therapy

 Prior treatment with any TNF alpha antagonist or steroid within 48 hours prior to initiation of IVIG

 Concurrent sulfasalazine therapy

 Active severe infections within 4 weeks before screening visit, or between the screening and baseline visits.

 SLE, history of multiple sclerosis, transverse myelitis, optic neuritis, or chronic seizure disorder

 Known HIV-positive status or known history of any other immuno-suppressing disease.

 Any mycobacterial disease or high risk factors for tuberculosis, such as family member with TB or taking INH

 Untreated Lyme disease

 Severe comorbidities (diabetes mellitus requiring insulin, CHF of any severity, MI, CVA or TIA within 3 months of screening visit, unstable angina pectoris, uncontrolled hypertension (sitting systolic BP > 160 or diastolic BP > 100 mm Hg), oxygen-dependent severe pulmonary disease, history of cancer within 5 years [other than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer])

 Exposure to hepatitis B or hepatitis C or high risk factors such as intravenous drug abuse in patient's mother, or history of jaundice (other than neonatal jaundice). SLE, history of multiple sclerosis, transverse myelitis, optic neuritis or chronic seizure disorder.

 Use of a live vaccine (Measles Mumps Rubella or Varicella) 30 days prior to or during this study.

 Any condition judged by the patient's physician to cause this clinical trial to be detrimental to the patient

 History of non-compliance with other therapies

 Must not have received immunosuppressive agents for at least three months prior to enrollment.

['Mucocutaneous Lymph Node Syndrome', 'Kawasaki Disease']

Mucocutaneous Lymph Node Syndrome
Kawasaki Disease