Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer

Summary: This randomized phase III trial studies oxaliplatin, leucovorin calcium, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin calcium, and fluorouracil in treating patients who have undergone surgery for stage II colon cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective than combination chemotherapy alone in treating colon cancer.
Inclusion criteria: inclusion criteria:

 STEP 1: INITIAL REGISTRATION

 The distal extent of the tumor must be >= 12 cm from the anal verge on endoscopy; if this distance was not confirmed on endoscopy pre-operatively, then the distal extent of the tumor must be >= 12 cm from the anal verge as determined by surgical examination; colonoscopy should be performed postoperatively for those unable to have a preoperative colonoscopy to guarantee there are no synchronous lesions; (if tumor is located beyond sigmoid colon and centimeter distance unavailable, include anatomic region of colon, e.g. right colon, transverse colon, hepatic flexure descending colon, cecum etc.)

 Patients must have paraffin-embedded tumor specimen available for evaluation of microsatellite instability and loss of heterozygosity at 18q, to determine high risk versus low risk

 High-risk patients will be randomized to treatment Arms A or B

 Low-risk patients will be registered to Arm C for observation

 NOTE: Every effort should be made to submit blocks (tumor and normal mucosa) to the Principal Coordinates Analysis (PCO) immediately; blocks CANNOT be accepted after day 50 (post surgery) in order to allow for molecular assessment

 Specific laboratory requirements for Step 2 must be obtained within 2 weeks prior to Step 2 randomization

 Patients must not have synchronous tumors

 Patients must not have appendiceal tumors

 Patients must not have a history of inflammatory bowel disease (IBD)

 Patients with hereditary non-polyposis colorectal cancer (HNPCC) are eligible

 Patients must have no history of isolated, distant, or non-contiguous intra-abdominal metastases, even if restricted

 Patients must have histologically confirmed adenocarcinoma of the colon that meets the criteria below:

 Stage II adenocarcinoma (pT3/pT4a/pT4b pN0 M0 according to the definitions of the American Joint Committee on Cancer, 7th Edition, 2010): the tumor invades through the muscularis propria into pericolic tissues (pT3), penetrates to the surface of the visceral peritoneum (pT4a), or directly invades other organs or structures (pT4b); patients with mesenteric tumor deposits or satellites without identifiable residual lymph node in the absence of lymph node involvement are now designated pN1c, rather than pT3; patients with such tumor deposits are not eligible for E5202; patients must have had a complete resection (R0 resection)

 Patients must have >= 8 lymph nodes evaluated and reported

 Patients must not have presented with clinical complete obstruction or perforation of the bowel

 Patients must not have had any systemic or radiation therapy initiated for this malignancy

 Patients must not have a previous or concurrent malignancy; exceptions are made for patients who meet any of the following conditions:

 Non-melanoma skin cancer, in situ cervical cancer, or breast cancer in situ

 Prior malignancy completely excised or removed and patient has been continuously disease free for > 5 years

 Patients with completely excised or removed breast cancer and disease free > 5 years, regardless of the continuation of hormonal therapy

 Patients with previous radiation therapy (RT) to the pelvic region will be ineligible

 Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

 STEP 2: RANDOMIZATION (HIGH RISK PATIENTS - ARMS A AND B ONLY)

 Within 2 weeks prior to randomization, postoperative absolute granulocyte count (AGC) must be >= 1500/mm^3 (or < 1500/mm^3, if in the opinion of the investigator, this represents an ethnic or racial variation of normal)

 Within 2 weeks prior to randomization, the postoperative platelet count must be >= 100,000/mm^3

 Within 2 weeks prior to randomization, there must be postoperative evidence of adequate hepatic function; bilirubin must be =< upper limit of normal (ULN) unless the patient has a chronic grade 1 bilirubin elevation due to Gilbert's disease or similar syndrome due to slow conjugation of bilirubin

 Within 2 weeks prior to randomization, there must be postoperative evidence of adequate hepatic function; alkaline phosphatase must be < 2.5 x ULN

 Within 2 weeks prior to randomization, there must be postoperative evidence of adequate hepatic function; aspartate transaminase (AST) must be < 1.5 x ULN

 Within 2 weeks prior to randomization, there must be postoperative evidence of adequate renal function; serum creatinine =< 1.5 x ULN

 Within 2 weeks prior to randomization, there must be postoperative evidence of adequate renal function; urine protein/creatinine (UPC) ratio of < 1.0; patients with a UPC ratio >= 1.0 must undergo a 24-hour urine collection, which must be an adequate collection and must demonstrate < 1 gm of protein in order to participate

 Patients with any significant bleeding that is not related to the primary colon tumor within 6 months prior to study entry are not eligible

 Patients with gastroduodenal ulcer(s) determined to be active by endoscopy are not eligible

 Patients with a history of hypertension must measure < 150/90 mmHg and be on a stable regimen of anti-hypertensive therapy

 Patients must not have a serious or non-healing wound, skin ulcers or bone fracture

 Patients experiencing clinically significant peripheral neuropathy at the time of step 2 randomization (defined in the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events version 4.0 [CTCAE 4.0] as grade 2 or greater neurosensory or neuromotor toxicity) are not eligible

 Patients must not have had invasive procedures, defined as follows:

 Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization

 Core biopsy or other minor procedure, excluding placement of a vascular access device, within 7 days prior to randomization

 Or anticipate the need for major surgical procedure(s) during the course of the study

 Patients must begin adjuvant treatment no less than 28 days and no more than 60 days from surgery

 Eligible patients of reproductive potential (both sexes) must agree to use an accepted and effective method of contraceptive during study therapy and for at least 3 months after the completion of bevacizumab; women must not be pregnant or breast-feeding; all females of childbearing potential must have a serum pregnancy test to rule out pregnancy within 2 weeks prior to step 2 randomization

 Patients with prothrombin time (PT) (international normalized ratio [INR]) > 1.5 are not eligible, unless the patient is on full-dose anticoagulants; if so, the following criteria must be met for enrollment:

 The subject must have an in-range INR (usually between 2 and 3) on a stable dose of warfarin or on a stable dose of low molecular weight heparin

 The subject must not have active bleeding or a pathological condition that is associated with a high risk of bleeding

 Patients with non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude any of the study therapy drugs are not eligible; specifically excluded are the following conditions:

 New York Heart Association (NYHA) class III or IV congestive heart failure

 Current symptomatic arrhythmia

 Any non-malignant systemic disease

 Patients with a history of transient ischemic attack (TIA) or cerebrovascular accident (CVA) are not eligible

 Patients with a history of the following within twelve months of study entry are not eligible:

 Arterial thromboembolic events

 Unstable angina

 Myocardial infarction

 Patients with symptomatic peripheral vascular disease are not eligible

 Patients with psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude them from meeting the study requirements are not eligible

 Patients must not have a known allergy to platinum compounds

 STEP 2: REGISTRATION (LOW-RISK PATIENTS - ARM C)

 Patients determined to be low risk are eligible
Exclusion criteria:

['Bevacizumab', 'Fluorouracil', 'Laboratory Biomarker Analysis', 'Leucovorin Calcium', 'Oxaliplatin']

Bevacizumab
Fluorouracil
Laboratory Biomarker Analysis
Leucovorin Calcium
Oxaliplatin

['Colon Mucinous Adenocarcinoma', 'Colon Signet Ring Cell Adenocarcinoma', 'Lynch Syndrome', 'Stage IIA Colon Cancer AJCC v7', 'Stage IIB Colon Cancer AJCC v7', 'Stage IIC Colon Cancer AJCC v7']

Colon Mucinous Adenocarcinoma
Colon Signet Ring Cell Adenocarcinoma
Lynch Syndrome
Stage IIA Colon Cancer AJCC v7
Stage IIB Colon Cancer AJCC v7
Stage IIC Colon Cancer AJCC v7


Effect of Varenicline on Reactivity to Smoking and Drinking Cues

Summary: Alcohol and nicotine dependence are often co-morbid, with 85% of alcoholics also smoking. However, very little research has been conducted into the nature of this co-occurrence. Thus, the main aim of this study is to assess differences in alcohol and tobacco consumption and cue-induced craving in treatment-seeking smokers after two weeks treatment of varenicline.~Hypotheses~Two weeks of varenicline treatment will significantly decrease cue-induced tobacco craving compared to placebo (Due to the actions of varenicline on alpha-4-beta-2 receptors and its downstream effect on dopamine release).~Varenicline will decrease cue-induced alcohol craving compared to placebo.~The impact of Varenicline on cue-induced alcohol craving will be greater in heavy drinkers compared to social drinkers.
Inclusion criteria: inclusion criteria: Heavy Smokers/Heavy Drinkers

 Treatment seeking smokers

 Age 18 to 65 years

 Smoke ≥ 10 cigarettes per day

 Fagerstrom Test of Nicotine Dependence score > 3

 Alcohol Use Disorders Identification Test (AUDIT) > 8

 Drink > 25 drinks per week for males or > 20 drinks per week for females

 Able to provide written informed consent

 inclusion criteria (Heavy Smokers/Social Drinkers):

 Treatment seeking smokers

 Age 18 to 65 years

 Smoke ≥ 10 cigarettes per day

 Fagerstrom Test of Nicotine Dependence score > 3

 Alcohol Use Disorders Identification Test(AUDIT) < 8

 Drink < 14 drinks per week for males or < 9 drinks per week for females

 Able to provide written informed consent

Exclusion criteria:  (Heavy Smokers/Heavy Drinkers):

 Any medical condition requiring immediate investigation or treatment

 Beck Depression Inventory score >16

 Insulin-dependent diabetes

 Drink > 70 standard alcoholic drinks per week for males or drink > 52 standard alcoholic drinks per week for females

 Pregnancy or lactation

 Current DSM-IV Axis 1 psychiatric disorder

 Regular use of any therapeutic or recreational psychoactive drug use during the last three months or other substance use disorder, with the exception of tobacco and alcohol.

['Tobacco Dependence', 'Alcohol Dependence']


Early Rehabilitation After Total Hip Replacement

Summary: The purpose of this study is to determine whether supervised progressive resistance training is effective in the early phase after Total Hip Replacement. The investigators hypothesise that 10 weeks of supervised, progressive resistance training immediately after discharge will lead to increased functional performance, muscle strength and muscle power compared to standard rehabilitation consisting of home-based exercise.
Inclusion criteria: inclusion criteria:

 Total hip replacement for osteoarthrosis

 Living within 30 km from the hospital

 Motivated to attend training 2 times/week in 10 weeks

 Reduced functional ability measured as: HOOS score < 67

 written informed consent

Exclusion criteria: :

 Comorbidities such as cancer, neuromuscular diseases, heart diseases etc.

 Cognitive impairment

 Body mass index > 35

 Resurfacing prosthesis

 Scheduled additional prosthetic surgery in lower extremity within 6 months

['Supervised progressive resistance training', 'Control group']


CDC Medicaid Asthma Home Visit Project

Summary: Asthmatic children age 3-17 from low income households in King County are randomly assigned into a community health worker (CHW) intervention group and a control group. The intervention is in-home education and support related to asthma self-management. The main outcome measures are asthma symptom-free days, caretaker's asthma-related quality of life score, and health care utilization for asthma measured at baseline and 12 months after baseline enrollment.
Inclusion criteria: inclusion criteria:

 caretaker is age 18 or older and child is age 3-17

 have not controlled as thma

 residence in King County

 spoken language is English or Spanish

 Child is enrolled in a Medicaid managed care health plan offered by Community Health Plan of Washington (CHPW) or Molina Health Plan of Washington, Inc (Molina).

Exclusion criteria: :

 Parent/guardian plans to move out of King County within the next year or lacks permanent housing.

 Parent/guardian has a mental or physical disability making it impossible to participate in the protocols.

 The household appears to be unsafe for visitation by the CHW.

 The child has other serious chronic medical conditions (e.g. poorly controlled sickle cell disease, cystic fibrosis) that cause sufficient limitation in functional status so that that asthma control is not a priority.

 The family is enrolled in another asthma research study within the past three years. This is to avoid the potential confounding effect from other studies.

 The child is in foster care or group care settings.


Observational Study of Botox® Treatment for Patients With Upper Limb Adult Spasticity

Summary: This is a prospective, non-interventional, observational study to collect data on the use of botulinum toxin Type A in a routine setting in patients with upper limb adult spasticity.
Inclusion criteria: inclusion criteria:

 Adult patients with upper limb spasticity following a stroke

 Eligible to receive botulinum toxin Type A

 No previous botulinum toxin Type A therapy

Exclusion criteria: :

 None


Safety and Efficacy of the Combination of Loop With Thiazide-type Diuretics in Patients With Decompensated Heart Failure

Summary: The purpose of this study is to determine whether a combined diuretic therapy (loop diuretics with thiazide-type diuretics) is more effective (in terms of improving fluid overload symptoms) among patients with decompensated heart failure in comparison with loop diuretic alone.
Inclusion criteria: inclusion criteria:

 History of chronic heart failure

 Admission for acute decompensated heart failure

 There is no prespecified inclusion criterion with respect to heart failure etiology and/or ejection fraction

 Receipt of an oral loop diuretic for at least 1 month before hospitalization, at a dose between 80 mg and 240 mg daily in the case of furosemide and an equivalent dose in the case of a different loop diuretic (20 mg of torasemide or 1 mg of bumetanide was considered to be equivalent to 40 mg of furosemide)

Exclusion criteria: :

 Other etiologies of fluid overload different from heart failure

 Hyponatremia: any symptomatic sodium value or a sodium level below 125mmol/l

 Unstable patients: acute coronary syndrome, cardiogenic shock or ICU admission.

 Patients requiring inotropic agents or renal replacement therapies

 Life expectancy < 6 months

 Prior treatment with thiazide-type diuretics

 Aldosterone antagonists are permitted if the patient had been taking them on a long-term basis (at least 30 days before randomisation)

 Pregnancy or breastfeeding period

 Active alcoholism and/or other substance abuse


Promoting Tolerance to Common Allergens in High-Risk Children: Global Prevention of Asthma in Children (GPAC) Study

Summary: The purpose of this study is to determine whether early childhood exposure to common allergens (substances that can trigger allergies and asthma) can prevent the development of asthma in children at high risk for developing the disease.
Inclusion criteria: inclusion criteria:

 Diagnosed with eczema (atopic dermatitis)

 Family history of eczema, allergic rhinitis, or asthma

 Allergy to one or more of the following: egg white, cow's milk, peanut, or soybean

 Weigh at least 9.5 kg (20.9 lbs)

 Parent or guardian willing to provide informed consent

Exclusion criteria: :

 Allergy to house dust mite, cat, or timothy grass

 Born prematurely (before 36th week's gestation)

 Previous diagnosis of asthma OR have had 3 or more distinct episodes of wheeze during the first year of life

 Chronic pulmonary disease

 Chronic disease requiring therapy

 Past or current treatment with systemic immunomodulator medication

 Past or current treatment with allergen-specific immunotherapy

 Received 10 or more days of systemic steroids in the 3 months prior to study entry

 Orofacial abnormalities that are likely to interfere with the subject's ability to take study treatment

 Participated in another clinical study within the 3 months prior to study entry

['Oral mucosal immunoprophylaxis (OMIP)', 'Placebo']

Oral mucosal immunoprophylaxis (OMIP)
Placebo


Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial

Summary: Bacterial vaginosis (BV) is a common, complex clinical syndrome characterized by alterations in the normal vaginal flora. Bacterial vaginosis has been associated with a variety of adverse health outcomes including endometritis; post-abortion endometritis; nongonococcal, nonchlamydial pelvic inflammatory disease; and an increased risk of acquiring and transmitting HIV infection. In pregnancy, BV is associated with premature rupture of the membranes, chorioamnionitis, amniotic fluid infection, preterm labor, preterm birth, and postpartum endometritis. Several studies have documented increased postpartum complications in the newborn and infants. The etiology of BV is poorly understood but recurrence is quite common despite treatment. Documented recurrence rate of up to 30% within three months are reported. Small studies have shown that adding vaginal acidifying gel to standard antibiotic regimens may reduce recurrence rates of BV. We plan an RCT comparing standard antibiotic therapy to antibiotics plus vaginal acidifying gel. Our hypothesis is that the addition of an acidifying gel will decrease the chance of recurrence of BV within 3 months.
Inclusion criteria: inclusion criteria:

 All women of between 18-50 years of age.

 Confirmed current diagnosis of BV using Amsel's criteria.

 Women with at least total 2 confirmed episodes of BV including most recent episode (by Amsel's criteria) within a six month period or at least total three or more in the past twelve months

Exclusion criteria: :

 Patient who received antibiotic therapy within the past two weeks.

 Patients who had co-existing gonorrhea or Chlamydia infection

 Any contraindications or sensitivity to taking the vaginal gel.

 Allergy to metronidazole

 Alcoholics or those unable to abstain from alcohol consumption.

 Pregnancy

['Vaginal acidifying gel (RepHresh)', 'Metronidazole control']

Vaginal acidifying gel (RepHresh)
Metronidazole control


Safety of and Immune Response to Two Different Dengue Virus Vaccines in Individuals Previously Immunized Against Dengue Virus

Summary: Dengue fever, which is caused by dengue viruses, is a major health problem in subtropical regions of the world. There are four different forms (serotypes) of dengue virus that can cause dengue fever. The purpose of this study is to determine the safety and immune response to a vaccine containing a particular dengue serotype when an individual has been previously vaccinated with a different dengue serotype.
Inclusion criteria: inclusion criteria:

 Previous vaccination with rDEN1delta30, rDEN2/4delta30(ME), OR rDEN4delta30 vaccine

 General good health

 Available for the duration of the study

 Willing to use accepted forms of contraception

Exclusion criteria: :

 Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease by history, physical examination, or laboratory studies including urinalysis

 Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, may interfere with the study

 Certain abnormal laboratory values

 Medical, work, or family problems as a result of alcohol or illegal drug use within 12 months of study entry

 History of severe allergy or anaphylaxis

 Severe asthma requiring an emergency room visit or hospitalization within 6 months of study entry

 HIV infected

 Hepatitis C virus infected

 Hepatitis B surface antibody positive

 Known immunodeficiency syndrome

 Use of corticosteroids or immunosuppressive drugs 30 days prior to study entry. Participants who have used topical or nasal corticosteroids are not excluded.

 Receipt of live vaccine within 4 weeks of study entry

 Receipt of killed vaccine within 2 weeks of study entry

 Absence of spleen

 Plan to travel to an area where dengue virus is common

 Any investigational product within 30 days of study entry

 Other condition that, in the opinion of the investigator, would interfere with the study

 Pregnancy or breastfeeding

['rDEN1delta30', 'rDEN2/4delta30(ME)', 'Placebo to rDEN1delta30 or rDEN2/4delta30(ME)']


Close Kinetic Chain Exercise With Kinesio Taping in the Management of Patellofemoral Pain Syndrome

Summary: The investigators will include patients attending outpatient clinic in the area of Orthopedics and Traumatology of our hospital with a diagnosis of unilateral Patellofemoral Pain Syndrome.~Two groups would be made, the control group will receive treatment with acetaminophen and physical therapy rehabilitation, closed chain exercises and stretches at home intended for the strengthening of quadriceps, abductors and internal rotators of the hip for the duration of six weeks. The experimental treatment group will receive the above plus the application of the technique NUCAP Medical Upper Knee Spider ® Kinesio taping on the affected knee. Both groups will be evaluated by an external consultation. They will be assessed by the Tegner Activity Scale, the Kujala score of the WOMAC and visual analog scale (VAS) for pain assessment; these scales will be applied at the beginning, third and sixth week
Inclusion criteria: inclusion criteria:

 Age between fifteen and thirty-five years,

 Presenting unilateral PFPS with six months of evolution,

 Presenting anterior or retro knee pain that presents itself when undergoing two or more of the following activities:

 (squatting, running,kneeling, jumping,climbing stairs,physically active patients, with at least thirty minutes of physical activity at least three times per week.)

Exclusion criteria: :

 Patients with previous knee surgeries,

 Chronic pain with more than one year of evolution,

 Pregnancy or suspected pregnancy

 Application of intra-articular steroids in the three months prior to their evaluation

 Patients with meniscal injuries

 Ligament or intra-articular knee structures

 Degenerative diseases such as diabetes

 Rheumatoid arthritis

 Osteoarthritis of the knee, hip or ankle

 History of dislocation or subluxation of patella

 Osgood Schlatter syndrome

 Patellar tendinitis or quadriceps.

['Acetaminophen 500mg', 'Kinesio taping']


Translation Evaluation of Aging, Inflammation and HIV in Lung Function (TEAL)

Summary: Hypothesis;Aging modifies the risk of pulmonary dysfunction in HIV+ individuals.~The study is a multicenter, prospective observational study of aging and pulmonary function in HIV. The investigator will determine the prevalence and risk factors for lung dysfunction as quantified by pulmonary function testing in both younger (<50 years) and older (≥50 years) HIV+ and HIV-uninfected controls. The investigator will build on existing cohorts and enrich enrollment for individuals over the age of 50 while adjusting for important co-variates such as ART, smoking history, co-infections, and illicit drug use. Evaluations will be scheduled at baseline, 18 months, and 36 months. Study visits will consist of blood draw, questionnaires, and pulmonary function testing.
Inclusion criteria: inclusion criteria:

 Pregnancy or breast-feeding.

 Contraindication to pulmonary function testing (i.e. abdominal or cataract surgery within 3 months, recent myocardial infarction, etc.).

 Increasing respiratory symptoms or febrile (temperature >100.40F [380C]) within 4 weeks of study entry.

 Hospitalization within 4 weeks prior to study entry.

 Uncontrolled hypertension at screening visit (systolic > 160 mm Hg or diastolic > 100 mm Hg) from an average of two or more readings. Subject may return for screening after blood pressure is controlled.

 Active cancer requiring systemic chemotherapy or radiation.

 Active infection of lungs, brain, or abdomen.

 Intravenous drug use or alcohol use that will impair ability to complete study investigations in the opinion of the investigator.

Exclusion criteria: :

 HIV+ young:

 HIV-1 infection, documented in medical record at any time prior to study entry.

 Men and women age 45 years and below.

 Ability and willingness to complete all tests.

 Participant in MACS, Women's Interagency Health Study and secondarily clinics and the community

 HIV+ old:

 HIV-1 infection, documented in medical record at any time prior to study entry.

 Men and women age 50 years and above.

 Ability and willingness to complete all tests.

 Participant in MACS, Women's Interagency Health Study and secondarily clinics and the community

 HIV- young:

 HIV-uninfected, documented at most recent MACS or WIHS visit.

 Men and women age 45 years and below.

 Ability and willingness to complete all tests.

 Participant in MACS, Women's Interagency Health Study and secondarily clinics and the community

 HIV- old:

 HIV-uninfected, documented at most recent MACS or WIHS visit.

 Men and women age 50 years and above.

 Ability and willingness to complete all tests.

 Participant in MACS, Women's Interagency Health Study and secondarily clinics and the community

['PFT', 'lab work', '6MWT', 'questionnaires']

['HIV', 'COPD', 'Pulmonary Disease', 'Aging']


SUrvey of Guideline Adherence for Treatment of Systolic Heart Failure in Real World

Summary: The purpose of this study is to survey the guideline compliance of the cardiologists in the treatment of systolic heart failure in Korea
Inclusion criteria: inclusion criteria:

 Subjects admitted to hospital with systolic heart failure(LVEF under 45%) in 2009

 Subjects, age 20 or/and above

 Subjects admitted to hospital (emergency area, to internal medicine or to cardiology wards, CCU or intensive care) with dyspnea and verification of heart failure based on following criteria;

 Symptoms typical of heart failure : breathlessness at rest or on exercise, fatigue, tiredness, ankle swelling and Signs typical of heart failure : tachycardia, tachypnoea, pulmonary rales, pleural effusion, raised jugular venous pressure, peripheral oedema, hepatomegaly

 Objective evidence of a structural or functional abnormality of the heart at rest : cardiomegaly, third heard sound, cardiac murmurs, abnormality on the echocardiogram, raised natriuretic peptide concentration

Exclusion criteria: :

 Subject who expired during hospitalization


Association Between Increased Oxidative Stress, Anti-Inflammatory Fatty Acid Formation, and Airway Infection in People With Asthma and Chronic Obstructive Pulmonary Disease

Summary: Chronic obstructive pulmonary disease (COPD) and asthma are common respiratory diseases in which people experience long-term inflammation of the lungs. Exacerbations, or prolonged worsening of symptoms, of asthma and COPD are often life-threatening and can lead to frequent need for hospitalization. Even with the proper use of bronchodilators, corticosteroids, and other currently available medications, clinical responses among people with COPD and asthma are variable. There remains a significant unmet clinical need for new therapeutic approaches and insights, including the identification of biomarkers to accurately assess the presence of airway infection and intensity of airway inflammation. This study will investigate potential natural biological causes and new biomarkers for increased susceptibility to persistent airway infection in asthma and COPD.
Inclusion criteria: inclusion criteria:

 No change from the MIA and LEUKO trials

Exclusion criteria: :

 No change from the MIA and LEUKO trials

['Asthma', 'Pulmonary Disease, Chronic Obstructive']

Asthma
Pulmonary Disease
Chronic Obstructive


Vibration Response Imaging (VRI) in Children With Acute Respiratory Symptoms

Summary: The VRI device may provide a complementary diagnostic tool for lung examination and aid the physician in determining whether a chest x-ray should be performed.
Inclusion criteria: inclusion criteria:

 Subject's parent or legal guardian, is able and willing to read the Informed Consent, understands the Informed Consent, and provides written Informed Consent for the subject; if the minor child is in fact able to give consent, the minor's consent must be obtained in addition to the consent of the minor's legal guardian.

 Boy or girl in the age range of 3-18 years.

 Patient presented with acute respiratory complaints, acute cough, onset of shortness of breath, or fever.

 Patient referred by ED physician and presented for CXR.

Exclusion criteria: :

 Body habitus or skin condition that might prevent the placement of the sound sensors on the back (e.g. severe scoliosis, kyphosis, chest wall deformation, skin lesion on the back or compression fracture);

 Potentially contagious skin lesion on the back;

 Subject has had lung surgery;

 Subject was prescribed the CXR for monitoring or follow up of a lung condition that pre-existed the current, acute symptoms.


A Minimally-invasive Approach to Cytoreduction and HIPEC for Peritoneal Surface Malignancy

Summary: The purpose of this study is to determine the feasibility of surgical techniques involving minimal entry into the living body approach for tumor reduction and treatment in which highly concentrated anticancer drugs are put directly into the abdomen through a tubes (HIPEC), and to determine if this approach may improve short-term postoperative outcomes, including the development of complications related to surgery within the first 30 days after surgery.~Participation in this study is entirely voluntary. Approximately 30 subjects will take part in this single-center study and all will be enrolled at University of California San Diego.
Inclusion criteria: inclusion criteria:

 Aged > 18 years old

 Capable of providing informed consent.

 Histologically confirmed peritoneal carcinomatosis from appendiceal, colorectal, ovarian, or primary mesothelioma, with no systemic metastases.

 Evidence of low-volume peritoneal disease defined by a PCI < 10 based on cross-sectional imaging / and / or diagnostic laparoscopy findings.

 Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status of 0-2.

 Patients who are medically fit for surgery defined as the following:

 No parenchymal hepatic metastases

 No evidence of clinical (jaundice), biochemical (abnormally elevated serum bilirubin and/or alkaline phosphatase) or radiological (ultrasound, CT, or MR) biliary obstruction

 No cross sectional imaging findings indicative of multi-segmental (>1 site) small bowel obstruction, or small bowel loops matted together, or gross disease of the small bowel mesentery characterized by distortion, thickening or loss of mesenteric vascular clarity

 No clinical or radiological evidence of hematogenous or distant nodal (retroperitoneal, pelvic, mediastinal, peri-portal or peri-aortic) metastasis

 Absolute neutrophil count (ANC) > 1200/mm3, white blood cell count (WBC) > 4000/mm3 and platelet count > 150,000/mm3

 An international normalized ratio (INR) ≤ 1.5 (patients who are therapeutically anticoagulated for unrelated medical conditions such as atrial fibrillation and whose antithrombotic treatment can be withheld for operation will be eligible).

 Adequate hepatic function must be met as evidenced by total serum bilirubin ≤ 1.5 mg/dl (patients with total bilirubin > 1.5 mg/dL eligible only with Gilbert's syndrome);

 Alkaline phosphatase < 2.5 times the upper limit of normal; and/or

 Aspartate transaminase (AST) < 1.5 times upper limit of normal (alkaline phosphatase and AST cannot both exceed the upper limit of normal)

 Serum renal functional parameters, blood urea nitrogen (BUN) and creatinine are within normal limits

 Satisfactory cardiopulmonary function (no history of severe congestive heart failure or severe pulmonary disease, as indicated by clinically acceptable risks to undergo major abdominal - cytoreductive surgery).

 No clinical history of acute myocardial infarction within six months of registration.

 Patients who are status post revascularization procedures with satisfactory cardiac function are eligible.

 No significant history of a medical problem or co-morbidity that would preclude the patient from undergoing a major abdominal operation such as a history of severe congestive heart failure or active ischemic heart disease.

 No concurrent second malignancy requiring systemic therapy.

 No psychiatric or addictive disorders or other conditions that would preclude the patient from meeting the study requirements.

Exclusion criteria: :

 Peritoneal carcinomatosis index (PCI) > 10

 Systemic (extraperitoneal) disease, pregnant, incarcerated.

 Pregnant and lactating women. Women of reproductive age must be willing to use contraception during study therapy.


A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)

Summary: The purpose of this study is to evaluate whether fostamatinib is safe and effective in the treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).
Inclusion criteria: inclusion criteria:

 Subject must have had a diagnosis of primary or secondary warm antibody AIHA.

 - Must have failed at least 1 prior treatment regimen for AIHA.

Exclusion criteria: :

 Subject with cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria.

 Subject with a platelet count of < 30,000/μL.

 Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosis (SLE), or lymphoid malignancy and the underlying disease is not stable or is not well-controlled on current therapy.

 Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure ≥ 130 mmHg, or diastolic blood pressure ≥ 80 mmHg.

['Warm Antibody Autoimmune Hemolytic Anemia']


Apligraf Versus Standard Therapy in the Treatment of Diabetic Foot Ulcers

Summary: The purpose of this study is to determine the ability of Apligraf to improve the time to and incidence of complete wound closure of diabetic foot ulcers, as compared to diabetic foot ulcers treated with standard therapy.
Inclusion criteria: inclusion criteria:

 diabetic ulcer of primarily neuropathic origin on the plantar region of the forefoot

 ulcer extending through the dermis but without sinus tract, tendon, capsule or bone exposure

 ulcer present for at least 2 weeks and measuring 1- 16 cm2

 diminished sensesation on target extremity/foot

 ulcer is not infected

 Type 1 or 2 diabetes with adequate glycemic control

 Adequate vascular supply to the target extremity

Exclusion criteria: :

 Charcot foot

 Non-neuropathic ulcers

 Skin cancer within or adjacent to the target ulcer

 Osteomyelitis or an infected ulcer

 Clinically significant medical condition that would impair wound healing

 Females who are pregnant

 Received within 4 weeks of study entry systemic corticosteriods, immunosuppresive agents, radiation therapy or chemotherapy


A Single-Center, Exploratory Study to Analyze the Dynamics of Skin Microflora Following Exposure to Surfactants

Summary: The purpose of this study is to understand the changes in skin microflora, skin barrier function, and skin biochemical constituents in response to direct contact with model surfactants used in personal care articles. The results from this study will provide insights into the complex interaction between the skin microbiome and the epidermis after exposure to surfactants.
Inclusion criteria: inclusion criteria:

 Healthy Subjects with Fitzpatrick Skin Types I, II or III

Exclusion criteria: :

 Subjects with visible skin disease, tattoos, skin condition, or abnormal skin color

['PEG-40 Hydrogenated Castor Oil (Tagat CH40, Evonik) 1.5%', 'Lauryl glucoside (Plantacare® 1200UP, BASF) 1.5%', 'Sorbitan palmitate (SPANTM 40 (powder), Croda) 1.5%', 'Silwet* DA-63 (Momentive) 1.5%', 'Sodium lauryl sulfate (Sigma Aldrich) 1.0%', 'Water (control)']


Education for Osteoporosis in Persons With Existing Fractures

Summary: We wish to investigate whether a weekly, 2½ hour group-based osteoporosis education intervention (the Osteoporosis Prevention and Self-Management Course), is different to one session course (1x 2½ hours) on osteoporosis knowledge, confidence to eat calcium-containing foods, confidence to exercise, and amount of exercise undertaken after three and nine months of follow-up in people aged over 50 years who have already had a bone fracture.
Inclusion criteria: inclusion criteria:

 Presented to Modbury Hospital's Accident and Emergency Department with a new bone fracture

Exclusion criteria: :

 Residence in nursing home

 Fracture sustained in motor bike, push bike or motor vehicle accident

 Fracture sustained due to high trauma, such as fall from roof or ladder

 Dementia

 Inability to participate in group settings

 Inability to understand spoken English

 Inability to provide informed consent

 Pathological fracture

 Usual place of residence outside South Australia

['Osteoporosis Prevention and Self-Management Course', 'Introductory education session on osteoporosis']


Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years

Summary: The aim of the trial was to evaluate the use of a tetravalent vaccine, CYD dengue vaccine, against dengue disease.~Primary Objectives:~To describe the humoral immune response to dengue before and after each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years) previously vaccinated with yellow fever (YF) vaccine.~To evaluate the safety of each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years).~To describe viremia after the first and second vaccinations with dengue vaccine in a subgroup of 130 randomized participants (100 participants in Dengue Vaccine Group and 30 participants in Control Group) in two age cohorts of children (6 to 11 years and 2 to 5 years).
Inclusion criteria: inclusion criteria :

 Aged 2 to 11 years on the day of inclusion.

 Participant in good health, based on medical history, physical examination and laboratory parameters.

 Provision of Assent Form signed by the participants (for participants >=8 years old) and Informed Consent Form signed by the parents or another legally acceptable representative (and by an independent witness for illiterate parent[s]).

 Participant and parents/legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures.

 For a female participant of child-bearing potential (girls post-menarche), avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first vaccination, until at least 4 weeks after the last vaccination.

 Documented receipt of yellow fever vaccine since at least one month before the first vaccination.

Exclusion criteria:  :

 Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.

 For a female participant of child-bearing potential (girls post-menarche), known pregnancy.

 For a female participant of child-bearing potential (girls post-menarche), known pregnancy or positive pregnancy test in blood sample taken at Screening.

 Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.

 Planned participation in another clinical trial during the trial.

 Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.

 Known systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.

 Systemic hypersensitivity to YF vaccine or history of a life-threatening reaction to YF vaccine.

 Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.

 Current or past alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures.

 Receipt of any blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response.

 Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.

 Planned receipt of any vaccine in the 4 weeks following the first trial vaccination.

 Human Immunodeficiency Virus, hepatitis B antigen, or hepatitis C seropositivity in blood sample taken at Screening.

 Clinically significant laboratory abnormalities (as determined by the Investigator) in blood sample taken at Screening.

 Known previous vaccination with pneumococcal polysaccharide vaccine.

['CYD Dengue Vaccine Serotypes 1, 2, 3, and 4', 'Pneumococcal polysaccharide vaccine']

['Dengue Virus', 'Dengue Fever', 'Dengue Hemorrhagic Fever', 'Dengue Diseases']

Dengue Virus
Dengue Fever
Dengue Hemorrhagic Fever
Dengue Diseases


Respiratory Therapy and Newborn Pain: Comparison Between Techniques

Summary: This study intend to assess the pain intensity of newborns in neonatal intensive care unit (NICU) undergoing different techniques of respiratory therapy and compare these procedures. A randomized controlled clinical trial and blind trial with newborns admitted to NICU. The babies were categorized according to gestational age , age, weight, diagnosis, support and signs of respiratory distress. Then, they were allocated by lot to come from one of 3 groups: G1 - control, G2 - undergoing physical therapy; G3 - received the thoracoabdominal rebalancing. Each newborn received just one physical therapy session in that they were assessed before one of the three procedures (T1), immediately after (T2) and after 15 minutes (T3). This evaluation found cardiorespiratory parameters (oxygen saturation, heart and respiratory rate) and three specific scales for pain assessment (NIPS, NFCS and PIPP). The hypothesis is that newborns hospitalized in intensive care unit did not show pain when undergoing respiratory therapy.
Inclusion criteria: inclusion criteria:

 Newborns up to 28 days with any weight and gestational age in ventilatory support or oxygen therapy and clinical indication for Physical Therapy.

Exclusion criteria: :

 Newborns with contraindication of respiratory therapy, those that had problems during any of the study procedures and changes in those suffering from respiratory support or oxygen therapy during data collection.

 If there was failure to collect any of the parameters for evaluating the newborn also was no longer part of the sample.

['Thoracoabdominal rebalancing', 'Physical Therapy']

Thoracoabdominal rebalancing
Physical Therapy

['Newborn Pain', 'Respiratory Therapy Techniques']

Newborn Pain
Respiratory Therapy Techniques


Unrestricted Rehabilitation Following Primary THA

Summary: The purpose of this study is to determine whether the form of rehabilitation following primary total hip arthroplasty has an influence on patient satisfaction or functional performance in the eighteen weeks following surgery.
Inclusion criteria: inclusion criteria:

 Age greater than 50 years

 Undergoing primary total hip arthroplasty at Holland Orthopaedic and Arthritic Centre

Exclusion criteria: :

 Any previous surgery about the ipsilateral hip

 Patients being considered for simultaneous bilateral total hip arthroplasty

 Patients with a neuromuscular disorder or recognized hypermobility syndrome

 Patients without sufficient language skills to communicate in spoken and written English

['Unrestricted rehabilitation', 'Standard rehabilitation']

Unrestricted rehabilitation
Standard rehabilitation


A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia

Summary: The purpose of the study is to evaluate sleep onset following administration of zolpidem tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients.
Inclusion criteria: inclusion criteria:

 Adults with history of sleeplessness

Exclusion criteria: :

 Allergic to investigational drug

 Any conditions and medications that may interfere with study drug evaluation

['zolpidem tartrate sublingual tablet', 'Placebo']

zolpidem tartrate sublingual tablet
Placebo


Safety and Tolerability of Lithium in Spinocerebellar Ataxia 2 (SCA2)

Summary: The purpose of this study is to determine safety and tolerability of the treatment with lithium in Spinocerebellar Ataxia 2. Moreover, clinical symptoms, neuronal loss, quality of life and depressive symptoms, will be considered to further investigate the effect of lithium therapy.
Inclusion criteria: inclusion criteria:

 Molecular diagnosis of SCA2 (≥34 CAG in the ataxin-2 gene)

 Age ≥18, <80

 SARA score ≥8

Exclusion criteria: :

 SARA score >32

 Heart failure

 Liver disease

 Kidney failure

 Thyroid disease

 Sick sinus syndrome and/or significant ECG alterations

 Hyposodemia

 Treatment with diuretics

 Treatment with haloperidol and/or other antipsychotics

 Treatment with NSAIDs or corticosteroids

 Treatment with ACE inhibitors

 Treatment with aminophyllines

 Treatment with mannitol

 Pregnancy and/or breastfeeding

 Acute diseases that might interfere with the trial


Evaluation of the Efficacy and Safety of Olanzapine for Anorexia Nervosa in Children and Adolescents

Summary: The purpose of this trial is to evaluate the safety and efficacy of the atypical antipsychotic, olanzapine, for the treatment of youth suffering from Anorexia Nervosa (AN).~Adolescent males and females between the ages of 11 and 17 years who are being treated by a physician on the Eating Disorder team at the Children's Hospital of Eastern Ontario will be invited to join the study if they have been diagnosed with AN or Eating Disorder Not Otherwise Specified (EDNOS), and if they weigh less than or equal to 85% of their ideal body weight. Those who meet inclusion and not exclusion criteria, and consent to participating in the trial will be offered adjunctive treatment with olanzapine. Those who agree to take olanzapine will belong to the olanzapine group, and those who decline will belong to the comparison group. Olanzapine doses will be in keeping with the investigators current clinical practice, with flex doses ranging from 1.25 mg to 10.0 mg daily (the majority of patients are treated with 2.5 mg or 5.0 mg at bedtime); dose adjustments made based on individual need and tolerability. Participants will remain in the study for 12 weeks. Those who initially decline olanzapine treatment may change their minds and take olanzapine up until week 9 of the trial.~It is hypothesized that those children and adolescents who choose to take olanzapine at entry into the trial will be more motivated to recover and more compliant with treatment. Compared to those who do not receive medication, it is expected that these adolescents will demonstrate reduced disordered eating attitudes and behaviours, as well as an increased rate of weight gain.~Finally, it is predicted that the rates of discontinuation and the adverse effects of olanzapine will be minor given the relatively low dose (as compared to treatment for patients with schizophrenia), slow titration, and short-term use of olanzapine the investigators will be using.~By comparing the well-being and outcome of patients in the two groups, the investigators hope to begin to answer the question of whether olanzapine does or does not lead to improved clinical outcome for patients with severe eating disorders such as AN or EDNOS, and the question of whether the benefits of using the medication outweigh the risks.
Inclusion criteria: inclusion criteria:

 Male or female between 11 and 17 (less than 18) at beginning of trial

 Based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), patient fulfills criteria for diagnosis of Anorexia Nervosa (of which there are two types: restricting or binge-eating/purging) or Eating Disorder Not Otherwise Specified, with a weight of less than or equal to 85% of his or her ideal body weight, as can best be determined at the time of assessment

 Treated by physician on the eating disorder team at the Children's Hospital of Eastern Ontario (CHEO)

Exclusion criteria: :

 Currently receiving treatment with any other antipsychotic medication, mood stabiliser, or stimulant

 Known diagnosis of: diabetes, impaired glucose tolerance, hyperlipidemia, hepatic dysfunction, substance dependence, narrow angle glaucoma, paralytic ileus, or pancreatitis, or any other medical illness that would be considered to significantly impact treatment or recovery from the eating disorder

 Any uncontrolled comorbid disease affecting any system including infectious, endocrine, renal, gastroenterologic, respiratory, cardiac, immunologic, or hematologic. Potential participants with controlled comorbidities in these areas may be invited to participate at the discretion of the primary investigator.

 Experienced one or more seizures without clear and resolved etiology

 Inability to comply with trial requirements including lack of comprehension of English

 Pregnant or breast-feeding

 High blood pressure

 Known allergy or known sensitivity to products in olanzapine

 Other unspecified reasons that, in the opinion of the investigator, amke the patient unsuitable for enrollment

 Officially declared incapable of consenting to treatment under the Mental Health Act (Note: If a patient is involuntarily hospitalized, he or she can be invited to participate provided that he or she has not officially been deemed incapable of making treatment decision under the Mental Health Act)

 Clinically judged to be at serious suicidal ris

 More than 6 months have passed between the patient's initial eating disorder assessment and the time of study entry

 Liver function test (ALT) > 1.5 x upper limit of normal (ULN)

 Positive pregnancy test

 Electrocardiogram (ECG): QTc > 450 msec or arrythmia other than sinus bradycardia; conduction abnormalities, prolonged QTc or other

 LDL-C > 4.9 mmol/L

 Total cholesterol/HDL ratio > 6

 Fasting glucose > or equal to 6.1 mmol/L

 Neutrophil count < 0.5 x 10^9/L

 Prolactin level at assessment > 200 ng/mL


Effects of Cognitive Behavioral Therapy on Brain Serotonin Activity in People With Depression

Summary: This study will examine changes in brain serotonin activity in people with depression before and after they receive cognitive behavioral therapy.
Inclusion criteria: inclusion criteria:

 DSM-IV diagnosis of major depressive disorder (MDD)

 Drug naive from prior psychotropic medication for more than 6 months before study entry

 Hamilton-Depression (HAM-D) 17 score greater than or equal to 16

 Woman of childbearing age with a negative pregnancy test within 48 hours of scanning

Exclusion criteria: :

 DSM-IV Axis I diagnosis other than MDD

 Use of psychotropic medication within 6 months of study entry

 History of bipolar disorder

 Current alcohol or drug abuse/dependence within 6 months of study entry

 History of sensitivity or intolerance to s-citalopram

 Medical contraindication to the use of s-citalopram

 Unstable medical condition (e.g., angina pectoris, untreated hypertension)

 Pregnant or nursing

 Woman of childbearing potential not using a medically acceptable form of birth control

 Actively suicidal or requiring hospitalization

 Requiring additional psychotropic drug therapy

 History of transient ischemic attacks

 History of cerebral infarction (including lacunar infarct with symptoms more than 24 hours in duration)

 History of Binswanger's disease or a history of hypertensive encephalopathy

 History of intracranial hemorrhage

 History of head trauma with loss of consciousness

 History of encephalitis

 History of extended exposure to known neurotoxin (e.g., cyanide, carbon monoxide)

 Uncontrolled metabolic disorder (e.g., thyroid disease, diabetes mellitus)

 History of cognitive impairment other than major depressive episode

 History of normal pressure hydrocephalus

 History of cancer metastatic to the central nervous system

 History of Parkinson's or other basal ganglia disease

 History of Guillain-Barré syndrome (chronic or relapsing polyneuropathy)

 Inability to undergo an MRI scan

['ADAM SPECT plus Cognitive Therapy', 'ADAM SPECT plus No Therapy']

ADAM SPECT plus Cognitive Therapy
ADAM SPECT plus No Therapy


Prevention of Weight Gain and Dyslipidemia by Green Tea in Patients Initiating Therapy With Olanzapine

Summary: The purpose of this study is to determine if taking green tea capsules can help prevent weight gain in patients that start therapy with Zyprexa® (olanzapine).
Inclusion criteria: inclusion criteria:

 Concurrently taking Zyprexa® for a psychiatric indication such as bipolar disorder or schizophrenia

 Stable body weight (+ 5%) for at least 2 weeks prior to baseline visit

 No weight loss program participation within past 3 months

Exclusion criteria: :

 Treatment with an atypical Anti-psychotic treatment other than olanzapine with the past 6 months

 BMI > 40 kg/m2

 Use of any dietary supplements related to weight gain or weight loss within past 1 month

 Use of any medication related to weight or plasma lipid concentration (other than hormonal contraceptives). This includes, but not limited to: antihypertensives, benzodiazepines statins, and psychostimulants.

 Uncontrolled hypertension (SBP >140 or DBP > 90 mmHg)

 Use of a hypertensive medication

 Known active alcohol or substance abuse or consumption of > three alcoholic beverages/day.

 Active cardiovascular disease


Evaluation of Polyflex Stenting in Esophageal Cancer Patients

Summary: To evaluate the effectiveness of an esophageal stent as a way to maintain nutrition during radiation and/or chemotherapy treatment.
Inclusion criteria: inclusion criteria:

 18 years of age and older

 Willing and able to provide informed consent

 Willing to comply with follow-up requirements

 Biopsy-confirmed esophageal cancer (adenocarcinoma or squamous cell carcinoma) in mid or distal esophagus (clinical stage 3 or less)

 Indicated for chemotherapy and/or radiation therapy

 Ability to dilate stricture to 15mm diameter at extent of disease evaluation

 Placement of at least 18 x 23mm diameter and 120mm length PolyFlex stent

Exclusion criteria: :

 Patients contraindicated for endoscopy

 Patients with prior esophageal stent placements

 Advance stage of disease, greater than T3 tumor or M1 disease


Efficacy and Safety of Fluticasone Propionate(FP)/ Salmeterol Xinafoate (SLM) Hydro Fluoro Alkane (HFA) Metered Dose Inhaler (MDI) in Pediatric Patients With Bronchial Asthma

Summary: This study is a multicenter, stratified, randomized, active control, double-blinded, parallel-group comparative study with an open-label extension period. The study is designed to evaluate the efficacy and safety of FP/ SLM HFA MDI 50/25 microgram (mcg) one or two inhalation twice daily (BID) for 8 weeks in comparison with FP HFA MDI 50 mcg one or two inhalation BID, in 6-month to 4-year-old Japanese patients with bronchial asthma. The study is also designed to evaluate the safety of long-term treatment of FP/ SLM HFA MDI 50/25 mcg one or two BID for 16 weeks.~The subjects meeting the eligibility criteria will enter the run-in period of 2 weeks and receive FP 50 mcg 1 or 2 inhalation bid (FP 100 or 200 mcg/day), before randomization. The subjects under 2 years of age at Visit 1 will receive only 1 inhalation bid during the run-in period. The subjects who meet the eligibility criteria for randomization will be stratified according to their age (<2 or >=2 year-old) at Visit 1 and randomized to one of the two treatment groups.~The total duration of participation in the study will be 10 weeks for a comparison period completion and 27 weeks for a completion.
Inclusion criteria: inclusion criteria:

 The written informed consent must be obtained from his/her parent or legally acceptable representative. If the investigator can get the oral consent from the patient, the investigator should record so in the informed consent which is signed by his/her parent or legally acceptable representative.

 Ethnic origin is Japanese

 Aged >=6 months and <=4 years at Visit 1.

 Male and pre-menarchial female. Pre-menarchial females are defined as any female who has yet to begin menses.

 Patient: outpatient

 Diagnosis as a pediatric asthma has been made by reference to JPGL 2012 and the document which is of help as evidence should be kept as source document. As for <2 years old, children are going to be diagnosed according to an instruction as follows in JPGL2012 as a reference. There are 3 or more episodes of marked expiratory wheezing, regardless of the presence of respiratory tract infection. It is also needed to confirm that there is asymptomatic period for about a week between each episode. In addition to this finding, if there is at least one of following findings, it is more helpful to diagnose infantile asthma: At least one of parents is diagnosed with bronchial asthma by a physician (including past history); Specific immunoglobulin E (IgE) antibody for inhalation antigen is detected in at least one of parents; Diseased child is diagnosed with atopic dermatitis by a physician (including past history); Specific IgE antibody for inhalation antigen is detected in diseased child; High serum IgE level in diseased child or his/her family (serum IgE level should be determined by considering age); Eosinophils and creola bodies found in sputum (examine nasal discharge eosinophilia and peripheral blood eosinophilia); Expiratory wheezing occurs when there is no airway infection; Expiratory wheezing and labored respiration or oxygen saturation are improved after beta-2 stimulant inhalation.

 A patient who needs to be treated with Inhaled corticosteroid (ICS)/ Long-acting beta 2 agonist (LABA) and fulfill following all conditions: At least one documented exacerbation in that the patient treated with systemic glucocorticosteroids, aminophylline dose intravenous(d.i.v) or continuous isoproterenol inhalation in the 12 months prior to Visit 1. Or a well-documented regular treatment with ICS (FP 200-400 mcg daily or equivalent) continuous use in the 12 months prior to Visit 1; The patient has not received systemic glucocorticosteroids, aminophylline d.i.v., ICS (FP>200 mcg daily or equivalent) or continuous isoproterenol inhalation within 4 weeks prior to Visit 1.

Exclusion criteria: :

 A patient who has suffered from upper and lower respiratory tract infection and then received medication within 2 weeks prior to Visit 1.

 A patient who is diagnosed upper and lower respiratory tract infection at Visit 1. Or a patient who has or is suspected to have deep-seated mycosis or infection to which no effective antibacterial agent is available. Or a patient who is suspected to have respiratory syncytial (RS) virus infection and cannot be identified to be negative for RS virus antigen.

 A patient who has respiratory disorder other than bronchial asthma, and the investigator judges the respiratory disorder affect the assessment of efficacy in this study.

 A patient who has unstable liver disease or chronic stable hepatitis B receiving significant immunosuppressive agents due to risk of hepatitis B reactivation.

 A patient who has malformation/foreign particle lodged in an airway. Or subjects who have known, pre-existing, clinically significant gastroesophageal reflux disease , endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment.

 A patient who has or is suspected to have hypersensitivity to study medications, the rescue medication or any ingredients of them.

 A patient who has been treated with another investigational product within 1 months prior to Visit 1 or within five half-lives (t-half) of the prior investigational study (whichever is the longer of the two).

 As for the patients who has evaluable ECG data at Visit 1, QT interval corrected (Fridericia) for heart rate (QTc[F])>=450 milliseconds (msec). The QT interval corrected for heart rate (QTc) should be based on averaged QTc values of triplicate electrocardiograms (ECGs) obtained over a brief recording period. As for the patients who don't has evaluable ECG data at Visit 1, if the patient has known prolonged QTc>=450 msec (any correction is valid), the patient will be excluded.

 A patient who is child in care (including foster parent system), or whom the investigator judges inappropriate for the study.

 Randomization Inclusion Criterion :

 A patient who has asthma symptoms scores (total of daytime and night-time) both over >=6 in total and >=1 per day for >=3 days at the last 7 consecutive days of the run-in period (excluding the day of Visit 2). Completion of symptom scores (daytime and night-time) on 5 or more days out of the last 7 consecutive days during the run-in period is required.

 Randomization

['FP/ SLM HFA MDI 50/25 mcg', 'FP HFA MDI 50 mcg']

FP/ SLM HFA MDI 50/25 mcg
FP HFA MDI 50 mcg


Right Ventricular Apical Versus True Mid-septal Pacing

Summary: Background Right ventricular (RV) artificial apical pacing can negatively impact synchrony of left ventricular contraction. The pacing from the septum of the RV can present an advantage in terms of less expressed dyssynchrony and reduced negative impact on left ventricular (LV) function. However, results of randomized studies comparing apical and septal pacing are not uniform. All these results have been affected by improper implantation of the septal lead, with many apparently septal leads being, in fact, implanted off-septum. The aim of the study is to compare true septal pacing with other RV pacing locations.~Methods/Design This is a prospective, randomized, single center study. Patients with standard indications for cardiac pacing with the expectation of high percentage RV pacing will be enrolled. They will be randomized into apical and septal pacing. The real location of leads in patients randomized to septal pacing will be confirmed using cardiac CT. After cardiac CT, three groups of patients will be created: 1) apical pacing, 2) true septal (in which the position of the lead has been verified to be in the septum), and 3) apparent septal (in which the position of the lead was found to be off-septum). Primary end-point are changes in standard echocardiographic parameters (LV ejection fraction, LV end-systolic volume, and LV end-diastolic volume) and the concentration of N-terminal pro brain natriuretic peptide (NT-proBNP) from baseline to 6 months, 1 year and three years. Secondary end-points are changes in echo-parameters of LV synchrony.~Discussion It is hypothesized that correct septal pacing will be associated with reduce negative impact on the function of the left ventricle (i.e. smaller decreases in LV EF and smaller increases in LVEDV, LVESV) and NT-proBNP, and less expressed LV dyssynchrony.
Inclusion criteria: inclusion criteria:

 Indication for cardiac pacing.

Exclusion criteria: :

 renal insufficiency

 iod allergy

 claustrophobia

 significant valvular disease

 recent acute coronary syndrome

 planned cardiac surgery

 ejection fraction of left ventricle less than 50%

 live expectancy less than 3 years

 expected non-compliance of the patient

['Pacing site - the implantation in the right ventricular (RV) apex', 'Pacing site - the implantation in the septum']

['Ventricular Rhythm From Artificial Pacing']


A Study of DAPD Alone Versus DAPD Plus MMF for Treatment of HIV Infection

Summary: The purpose of this study is to evaluate the safety, efficacy, and side effects of beta-D-2,6-diaminopurine dioxolane (DAPD) compared to DAPD plus mycophenolate mofetil (MMF) when these drugs are added to the anti-HIV treatment regimens of people infected with HIV.~Some studies have shown that DAPD and MMF can help fight HIV. However, neither DAPD nor MMF has been approved by the Food and Drug Administration for treating HIV infection. This study will help doctors decide if DAPD and MMF are good drugs for treating HIV.
Inclusion criteria: inclusion criteria for Step 1:

 HIV infected

 Triple-class antiretroviral treatment, as determined by the site investigator and as defined by all of the following: a) exposure to 2 or more nucleotide reverse transcriptase inhibitors (NRTIs) for at least 3 months each; b) exposure to 2 or more non-boosted protease inhibitors (PIs) for at least 3 months each, or exposure to a dual PI regimen for at least 3 months; and c) exposure to at least 1 non-nucleotide reverse transcriptase inhibitor (NNRTI) for at least 3 months.

 CD4 cell count of at least 50 cells/mm3 within 45 days prior to study entry

 Viral load of 2000 copies/ml or more within 45 days prior to study entry

 On current antiretroviral treatment regimen for at least 30 days prior to study entry. If current treatment includes abacavir, abacavir must be discontinued at least 30 days prior to study entry.

 Willing to use acceptable methods of contraception

Exclusion criteria:  for Step 1:

 Pregnant or breastfeeding

 Allergy or sensitivity to the study drugs and their formulations

 Diabetes mellitus

 Cataracts or any measurable loss of vision due to lens opacity

 Best-corrected visual acuity worse than 20/200

 Certain drugs or vaccines within 30 days prior to study entry

 History of any of the following: kidney disease; serious illness within 14 days prior to study entry; end organ cytomegalovirus infection; Kaposi's sarcoma; cataracts; active herpetic infection or peptic ulcer disease within 12 months; or malabsorption, severe chronic diarrhea, or inability to eat 1 or more meals a day because of chronic nausea, emesis, or abdominal/mouth and throat discomfort

 Current alcohol or drug abuse that would interfere with adherence to study requirements


Inhaled Corticosteroids in U-5 Children With Acute Respiratory Infection in Uganda: A Randomised Trial

Summary: The purpose of this study is to find out whether adjunct treatment with inhaled corticosteroids lead to faster improvement and reduce mortality of children under 5 years of age admitted to hospital with ALRI.
Inclusion criteria: inclusion criteria:

 children aged 2 to 59 months with cough and or difficult breathing

Exclusion criteria: :

 Presence of a serious concurrent illness such as meningitis, Children with congenital or acquired heart disease Severe anaemia Measles pneumonia Foreign body inhalation A confirmed diagnosis of pulmonary tuberculosis

['Bacterial Pneumonia', 'Viral Pneumonia', 'Acute Asthma']

Bacterial Pneumonia
Viral Pneumonia
Acute Asthma


Clinical Evaluation of Ropinirole Prolonged Release/Extended Release (PR/XR) Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's Disease

Summary: To investigate the efficacy and the safety of ropinirole PR/XR tablets to ropinirole immediate release (IR) tablets with advanced Parkinson's disease in conjunction with L-dopa in a double-blind, parallel group comparison study.
Inclusion criteria: inclusion criteria:

 inclusion criteria at the start of the screening

 Patients who are diagnosed with advanced Parkinson's disease (PD) with severity of the modified Hoehn & Yahr criteria Stages II-IV.

 Subjects receiving a stable dose of L-dopa for at least 4 weeks prior to screening phase and demonstrating lack of control with L-dopa therapy in the following circumstances. Wearing-off phenomena. On-off fluctuations. Delayed-on/No on phenomena. Not adequately controlled on L-dopa

 QTc<450 millisecond (msec) or <480msec for patients with Bundle Branch Block - values based on either single ECG values or triplicate electrocardiogram (ECG) averaged QTc values obtained over a brief recording period.

 Age:20 years or older(at the time of informed written consent)

 Informed consent: Patients who are able to give informed written consent in person. (i.e. patients who are capable of giving informed written consent on one's own)

 Sex: either sex. Female of child-bearing potential will be eligible for inclusion in this study. However they have to have a negative pregnancy test at the screening visit, agree to further pregnancy testing at the time points determined in study assessments and procedures and practice one of the following methods of contraception from the screening visit until the end of the follow-up examination. Abstinence. Injectable progestogen. Implants of levonorgestrel. Estrogenic vaginal ring. Percutaneous contraceptive patches. Intrauterine device (IUD) or intrauterine system (IUS) that meets the SOP effectiveness criteria as stated in the product label. Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. Double barrier method: condom or occlusive cap (diaphragm or cervical / vault caps) plus spermicidal agent (foam /gel / film / cream / suppository)

 Both inpatient and outpatient status.

 inclusion criteria at the start of the non-inferiority verification phase

 -Patients whose Unified Parkinson's Disease Rating Scale (UPDRS) PartIII total (on) scores is 10 points or more at week 0.

Exclusion criteria: :

 Late stage advanced subjects demonstrating incapacitating peak dose or biphasic dyskinesia on their stable dose of L-dopa.

 Patients who present serious physical signs and symptoms other than those of the PD (e.g. cardiac/hepatic/renal disorder and haematopoietic disorder). The severity refers to Grade 3 according to the Classification of the Severity of Adverse Experiences (Pharmaceutical affairs bureau/Safety division (PAB/SD) Notification No. 80, dated 29 June 1992).

 Patients with symptomatic postural hypotension. (e.g. dizziness and syncope).

 Patients with a current or history of drug abuse or alcoholism.

 Patients who have received surgical treatment for PD in the past (e.g. pallidectomy, deep brain stimulation).

 Female patients who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study or within 30 days after the last dose of the study drug.

 Patients with chronic hepatitis typeB and/or type C which is positive of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody.

 Patients with a history of drug allergy to ropinirole hydrochloride (HCl).

 Patients with a current or history of cancer or malignant tumor.

 Others whom the investigator (subinvestigator) considers ineligible for the study.


A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients

Summary: The purpose of this study is to investigate the efficacy and safety of zolpidem MR (modified release) compared to zolpidem IR (immediate release) in patients with primary insomnia.
Inclusion criteria: inclusion criteria:

 Diagnosis of primary insomnia based on DSM-IV criteria (307.42)

 Written informed consent has been obtained

Exclusion criteria: :

 Patients with sleep apnea syndrome, narcolepsy, presence or suspicion of periodic leg movement or restless leg syndrome

 Patients with hepatic failure, myasthenia gravis, or hypersensitivity to zolpidem

 Patients who are known to be current drug or alcohol abuser or likely to concomitantly consume alcoholic beverages (more than 3 times/week)

 Patients who have received antihistamines or antipsychotics will not allow to discontinue the previous medication throughout the study

 Patients who are pregnant, lactating or intend to become pregnant during the study period

 Patients who have received antidepressants or anxiolytics will not allow to change the dose or discontinue the previous medication throughout the study

 Any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial

 Participation in any clinical trial within 1 month prior to randomization

['Sleep Initiation and Maintenance Disorders', 'Primary Insomnia']


Assessing Endoloop-assisted Polypectomy in Patients With Antiplatelet Therapy

Summary: The aims of this study were to examine: 1) safety and feasibility of antiplatelet therapy interruption 7 days prior to polypectomy in patients with long-term antiplatelet therapy; 2) safety and feasibility of endoloop assisted snare polypectomy in patients with long-term antiplatelet therapy; 3) safety and feasibility of so called ligate and let go approach in patients with long-term antiplatelet therapy.
Inclusion criteria: inclusion criteria:

 pedunculated colorectal polyps

 larger than 2cm in diameter

 long-term antiplatelet therapy

Exclusion criteria: :

 presence of intraepithelial

['Endoloop-assisted ligate and let go colorectal polypectomy', 'Endoloop-assisted snare colorectal polypectomy']


Biomarkers for Breast Cancer Risk in African American Women

Summary: Background:~- At present, women do not have very accurate tests to inform of them of their personal risk of developing breast cancer. More information on the changes associated with both benign and cancerous breast lesions will help develop better risk information. Researchers have been looking at cells found in breast milk to study genetic changes related to breast cancer. However, most of these cell samples have been collected from white women. A new study wants to collect breast milk samples from African American women for further research. Comparing the results of genetic tests will help improve understanding of breast cancer risk in all women.~Objectives:~- To study genetic changes related to breast lesions, including breast cancer, in African American women.~Eligibility:~- African American women at least 18 years of age who are nursing a baby and who either have had or are being considered for a breast biopsy.~Design:~Participants will be screened with personal health questions.~Participants will receive a box with sterile bottles for milk collection. They will collect two breast milk samples, one from each breast. They will also fill out a questionnaire about their medical history.~The box with the samples and the questionnaire will be returned to the clinical center for study.~After the box is returned, participants will be asked to provide a copy of the biopsy report for any breast biopsies they have had.~There will be a followup phone call every year. Participants will provide health history information. This information will include whether they have been diagnosed with breast cancer in the previous year.
Inclusion criteria: inclusion criteria:

 Any woman who identifies as African American, Black, or African

 Currently nursing a baby

 Able and willing to sign written informed consent

 Willing to be contacted by study personnel for follow-up to determine whether a biopsy took place

 Willing to have her milk sample archived for future analyses

Exclusion criteria: :

 The woman does not consider herself to be of African American, Black, or African. These women may participate in the other ongoing Breast Milk Study at University of Massachusetts.

 Unable to sign written Informed Consent or Assent Form.

 Unwilling to be contacted by study personnel.


Treatment of Coronary Heart Disease With Amiloride

Summary: Treatment of coronary artery disease is a major health care problem across the entire word, and the United States. Unfortunately, despite a number of medical advances, diagnostic procedure, or epidemiological studies, the treatment of these patients remain complex, and and at times frustrating. In fact, the COURAGE trial conducted in 50 centers across United States and Canada documented that drug treatment, coronary interventions or both were not effective solution in coronary artery diseases.~A novel approach has recently been developed, based on the critical role of the potassium (K) content in red-blood-cell in myocardial oxygenation, since oxygen and K binding by hemoglobin (red-blood-cell) occurs simultaneously in blood passing through the lungs, whereas in the organs as the heart, the hemoglobin release both Oxygen and K ions.~This apparently simple mechanisms occurs in human blood in all individuals but could be altered in subjects with acquired or hereditable defect in red-blood-cell K content. The purpose of this trial, thus, will be to evaluate the pharmacological effects of Amiloride on RBC K-uptake and transport and its impact on reversion of angina, electrocardiographic changes of myocardial ischemia and electrical regeneration of the heart in subjects with coronary artery diseases.
Inclusion criteria: inclusion criteria:

 Male or female; age 35-75 years having angina (Canada Cardiovascular Society Class II-IV)

 Essential Hypertension defined as taking at least 1 anti-hypertensive medication, or average systolic blood pressure ≥140 mm Hg, or diastolic blood pressure ≥90 mmHg

 ST-T changes of LVH (Romhilt-Estes or Framingham Heart Study criteria, with typical LV strain pattern, or isoelectric, inverted or biphasic T waves)

 ST-T changes of ischemia in resting ECG (ST depression, isoelectric, biphasic, negative or inverted T-waves)

 Serum potassium < 5.0 mmol/L prior to randomization

 Negative pregnancy test in child-bearing potential women

 Willing to comply with scheduled visits

 Informed consent form signed by the subject

Exclusion criteria: :

 Resistance hypertension despite 3-drugs treatment

 Myocardial infarction in past 90 days

 Coronary artery bypass graft surgery in past 90 days

 Atrial fibrillation with a resting heart rate > 90 bpm

 Percutaneous coronary intervention in past 30 days

 Implanted Pacemaker

 Stroke in past 90 days

 Left or Right Ventricular Branch Block

 Aldosterone antagonist or K sparing drug in last 7 days

 Intolerance to amiloride

 Lithium use

 Current participation in any other therapeutic trial

 Any condition that may prevent the subject from adhering to the trial protocol

 History of hyperkalemia (K ≥5.5 mmol/L) in the past six months or K >5.0 mmol/L within 2 weeks

 Chronic renal dysfunction

 Liver disease

 Chronic pulmonary disease

 Significant uncorrected valvular heart disease

['Amiloride', 'Nitrates, clopidogrel, aspirin, statins']

Amiloride Nitrates clopidogrel aspirin statins


Acceptability of Human Papillomavirus (HPV) Vaccine in Female Sex Workers

Summary: The primary objectives of this study are to determine the acceptance and potential for the effective use of HPV vaccine in the standard and a modified schedule in female sex workers. Secondary objectives include ascertaining the prevalence of HPV types among female sex workers by age and sexual experience.
Inclusion criteria: inclusion criteria:

 Between the age of 18 and 26 years

 Registered female sex worker living in Lima

 Healthy with no known immune deficiency

 Willing to participate in a study of HPV vaccine including a Pap smear, three pregnancy tests, blood draws, and three vaccine administrations over 7 months

 Willing to provide informed consent

Exclusion criteria: :

 Currently pregnant or planning to get pregnant in the next six months

 Known immune deficiency disorder

 Current receipt of immunosuppressive drugs

 Allergy to yeast or known contraindication to HPV vaccine

 Women who have had their cervix removed

 Previous HPV vaccination

 Current fever over 100 degrees Fahrenheit


Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal Cancer

Summary: Elderly patients with esophageal cancer will receive thoracic radiation therapy 54-60Gy over 30 fractions, and concurrent with Gefitinib.
Inclusion criteria: inclusion criteria:

 Histologically documented diagnosis of esophageal Cancer

 Disease must be encompassed in a radiotherapy field.Patients with celiac, perigastric, mediastinal or supraclavicular adenopathy are eligible

 age:70-85 years

 Written informed consent.

 Performance status of 0 to 2

 Neutrophil count >1.5 x 10 to the 9th power/L and platelets > 100 x 10 to the 9th power/L.

 Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN (or less than or equal to 5 times ULN in case of known liver involvement

 Renal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN)

Exclusion criteria: :

 Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi.

 Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).

 Prior systemic chemotherapy or radiation therapy for esophageal cancer


Clinical Pediatric Pneumonia Score in Critically Ill Children

Summary: The purpose of the study is to create a clinical pneumonia tool that can be used to predict the cause of community-acquired pneumonia, which is a lung infection that began outside of the hospital in critically ill children therefore limiting unnecessary antibiotic use. The investigators will enroll critically ill children admitted with acute respiratory failure and suspected pneumonia. Each patient will receive a clinical pneumonia score blinded from culture and respiratory viral panel results. All care after samples obtained will be at the discretion of the PICU team. The investigators believe that our clinical pneumonia scale with procalcitonin will accurately designate viral from bacterial etiologies.
Inclusion criteria: inclusion criteria:

 All intubated pediatric patients

 Age 1 day to 21 years

 Admitted to the LLUCH PICU with suspected pneumonia for the next 6 months

 Have received antibiotics for less than 12 hours

 Have been intubated for less than 24 hours

 Patients must be English or Spanish speaking for consent purposes.

Exclusion criteria: :

 Patients who have received antibiotics for greater than 12 hours

 Patients who have been intubated for greater than 24 hours

 Patients who are unable to tolerate non-bronchoscopic bronchoalveolar lavage


Studies on the Pathogen, Vector Control and Clinical Treatment of Dengue Fever in Guangzhou

Summary: The purpose of this study is to elucidate the local epidemic problem and epidemiological characters of dengue fever in Guangzhou, to establish diagnostic and treatment standard and clinical treatment system of severe cases to reduce the morbidity and mortality of dengue fever.
Inclusion criteria: inclusion criteria:

 Dengue patients confirmed by dengue virus NS1 or RNA

Exclusion criteria: :

 Pregnant women

 Fever diseases caused by other viruses

 Combined bacterial infection

 Without complications such as diabetes and tumor.


Chronic Subdural Hematoma - Reduction of Recurrence by Treatment With Angiotensin Converting Enzyme Inhibitors

Summary: The project aims at investigating if treatment with the Angiotensin Converting Enzyme inhibitor Coversyl (perindopril) for 3 months after surgery for chronic subdural hematoma will decrease the risc of recurrence.
Inclusion criteria: inclusion criteria:

 Patients with chronic subdural hematoma that needs surgical evacuation

 Age > 18 year

Exclusion criteria: :

 Lack of compliance

 Kidney artery stenosis

 Stenosis of the aorta

 Severely decreased kidney function

 Allergy or intolerance/contraindications toward ACE inhibitors

 Already in ACE inhibitor treatment

 Coagulopathies

 Malignant disorders

 Fertile women

 Other neurological disorders

 Treatment with pharmaceuticals contraindicating treatment with ACE inhibitors


Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression

Summary: The investigators plan to enroll 184 women who are planning to breastfeed and use DMPA after delivery to find out whether the timing of postpartum administration of DMPA (prior to hospital discharge or 4-6 weeks after delivery) affects the duration or exclusivity of breastfeeding among women who plan to breastfeed their infants.
Inclusion criteria: inclusion criteria:

 Age > 18 years old and > 24 0/7 weeks pregnant at time of enrollment

 Planning to deliver at Magee-Womens Hospital and to breastfeed

 Plans to use DMPA for postpartum contraception for at least 6 months

 Willing and able to provide informed consent in English and to comply with study protocol

Exclusion criteria: :

 Intolerance of irregular vaginal bleeding

 Severe coagulation disorder

 Severe liver disease (LFTs >2x upper limits of normal at time of randomization)

 Contraindications to breastfeeding: maternal HIV infection; active herpes simplex with breast lesions; active varicella; active, untreated tuberculosis; antineoplastic, thyrotoxic, or immunosuppressive medications; concern that the infant may have galactosemia

 History of breast cancer, reduction or augmentation surgery

 History of severe clinical depression

 Multiple gestation

['Depot medroxyprogesterone acetate', 'Depot medroxyprogesterone acetate']

Depot medroxyprogesterone acetate
Depot medroxyprogesterone acetate

['Contraception', 'Postpartum Depression', 'Lactation']

Contraception
Postpartum Depression
Lactation


Treatment of Drooling With Type A Botulinum Toxin in Children With Cerebral Palsy

Summary: The purpose of this study is to evaluate the effectiveness of botulinum toxin injection to treat drooling in children with cerebral palsy, and to find the most appropriate dosage, duration of effect and side effects.
Inclusion criteria: inclusion criteria:

 diagnosis of cerebral palsy

 severe drooling

 aged 6-21 yrs

 subjects (or their guardian) who are able to understand the requirements of the study and sign the informed consent form

Exclusion criteria: :

 age below 6 yrs or above 21 yrs

 known allergy or sensitivity to the study medication or its component

 diagnosis of myasthenia gravis, amyotrophic lateral sclerosis or any other disease that might interfere with neuromuscular function

 subjects who have prior surgery of the submandibular gland

 subjects who are receiving medication that affect drooling such as anticholinergic drug

 inability to give informed consent


Telithromycin in Respiratory Tract Infections

Summary: Primary Objectives:~The primary objective of the study is to evaluate clinical efficacy i.e. to show that with respect to clinical cure rate, Ketek® (telithromycin) in the treatment of community acquired respiratory tract infections: community acquired pneumonia (CAP), acute bacterial exacerbation of chronic bronchitis (AECB) and acute sinusitis (AS), in outpatients.~Secondary Objectives:~The secondary objectives are to:~Further assess the efficacy of Ketek® (telithromycin) by considering the rate at which additional antibacterials were prescribed to treat the primary infection; the rate of hospitalisation due to a complication of the primary infection and assessment of bacteriological data, chest X-ray and sinus X-ray if available.~Evaluate safety of Ketek® (telithromycin) through Adverse Event (AE) and Serious Adverse Event (SAE) reporting
Inclusion criteria: inclusion criteria:

 General Conditions

 Outpatients

 Fulfillment of clinical diagnostic criteria for one of the following indications:

 Mild to moderate Community Acquired Pneumonia (CAP)

 Acute bacterial Exacerbation of Chronic Bronchitis (AECB)

 Acute Sinusitis (AS)

 For CAP

 The Criteria to be fulfilled are:

 New onset of at least two of the following:

 Cough

 Production of purulent sputum

 Auscultatory findings compatible with pneumonia, e.g. rales, evidence of pulmonary consolidation

 Dyspnea or tachypnea

 Fever

 Elevated total white blood cell count > 10 000/mm3 or >15% bands regardless of total count

 Chest X-ray findings supporting a clinical diagnosis of bacterial pneumonia (e.g. new infiltrate)

 For AECB

 The Criteria to be fulfilled are:

 Chronic bronchitis defined as cough and excessive sputum production for more than 2 consecutive years and on most days in a 3-month consecutive period.

 Exacerbation defined by:

 Increase in sputum purulence, or

 Increase in sputum volume, or

 Increase in dyspnea

 For AS

 The criteria to be fulfilled are:

 At least two of the major or one major and two minor factors listed below, for more than one week and less than 4 weeks:

 Major factors:

 Facial pressure and/or pain

 Facial congestion or fullness

 Nasal obstruction

 Nasal purulence or postnasal discharge

 Hyposmia or anosmia

 Fever

 Minor factors:

 Headache

 Halitosis

 Fatigue

 Dental pain

 Cough

 Ear pain, pressure or fullness

Exclusion criteria: :

 General Conditions

 Subjects presenting with any of the following will not be included in the study:

 Treatment required during the study with ergot alkaloid derivatives, pimozide, astemizole, terfenadine, cisapride, simvastatin, atorvastatin and lovastatin, and the oral use of the benzodiazepines midazolam, triazolam and alprazolam.

 History of congenital or family history of long QT syndrome (if not excluded by ECG) or known acquired QT interval prolongation.

 Known hypersensitivity to telithromycin or to macrolide antibiotics.

 Hospital acquired infections (hospitalization for more than 72 hours within 7 days of study entry).

 Pregnant or breast-feeding women. For the women of childbearing potential it is left to the investigators discretion to establish a lack of pregnancy, e.g. with contraceptive use, menstrual pattern, urinary pregnancy test.

 Subjects with severely impaired renal function (creatinine clearance <30 ml/min).

 Subjects that had received anti-bacterials for more than 24 hours within 7 days prior to enrollment in the study, unless the treatment has failed.

 Subjects receiving medications, including other anti-microbials or anti-cancer drugs, that could interfere with the evaluation.

 Microbiologically documented infection with a pathogen known prior to inclusion to be resistant to the study medications.

 Infection, other than the primary infection for which the subject is being included in the study that requires use of other systemic anti-bacterial drug.

 Splenectomised subjects.

 Use of Ketek® (telithromycin) or participation in a study using Ketek® (telithromycin) in the previous 30 calendar days.

 Subjects that have received any investigational drug within 4 weeks of enrollment in the study.

 No subject will be allowed to enroll in this study more than once.

 For CAP

 Additional


Objective Functional Outcome Measures in Orthopedic Surgery Using Advanced Tracking Technologies

Summary: The proposed project will address the measurement and ramifications of out-of-home mobility problems in various orthopedic disorders in an innovative way, using advanced tracking technologies.
Inclusion criteria: inclusion criteria:

 Unwillingness to sign informed consent.

Exclusion criteria: :

 Pregnancy.


Efficacy of AC-150 for the Treatment of Allergic Conjunctivitis in the Enviro-CAC™ Model

Summary: The purpose of this study is to evaluate the efficacy of AC-150 compared to vehicle and its components in the prevention of the signs and symptoms of allergic conjunctivitis in Enviro-CAC™ Model.
Inclusion criteria: inclusion criteria:

 Positive bilateral conjunctival allergen challenge(CAC) reaction

Exclusion criteria: :

 Known contraindications or sensitivities to the study medication or its components.

 Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.

 Use of disallowed medications during the period indicated prior to study enrollment or during the study.


Efficacy and Tolerability Study of Betahistine to Ameliorate Antipsychotic Associated Weight Gain

Summary: The study attempts to evaluate a histamine analog long used for the treatment of Meniere's disease, betahistine, that shows promise in reversing the antihistaminergic effects thought to be involved in antipsychotic induced weight gain.~Hypothesis to be tested:~A. Patients who have gained a developmentally inappropriate amount of weight on antipsychotics (AP) will see their weight and BMI decrease with betahistine augmentation as compared to placebo augmentation.~B. Betahistine augmentation in AP treated patients will increase levels of satiety in a standardized meal situation and decrease caloric intake as compared to placebo augmentation.~C. Metabolic effects of betahistine augmentation in AP treated patients will be reflected in differences in waist circumference, hip circumference and waist hip ratios D. Betahistine augmentation in this population will lead to decrease in fasting glucose-lipid lab values related to the development of metabolic syndrome as compared to placebo augmentation
Inclusion criteria: inclusion criteria:

 Adolescents and Adults ages 12-59 with a diagnosis of Schizophrenia, Schizoaffective Disorder, Schizophreniform, Bipolar I, Bipolar II, Bipolar NOS or Psychotic Disorder NOS, Autism Spectrum Disorder

 Patients will be currently treated with antipsychotics

 Patients will qualify for entry if they meet the following weight criteria:

 The patient has gained 7% of their weight since beginning of treatment with one or more of the current antipsychotics.

 The patient has had an increase of 7% of their weight during the last year while being treated with antipsychotics.

 The patient has a BMI of 30 or more and has gained 10 lbs or more in the past 8 months while being treated with antipsychotic medications.

 The patient has a BMI of 35 or greater at the current time, and his chart shows a history of consistent weight gain over the past 1 to 3 years during treatment with antipsychotics.

 .

Exclusion criteria: :

 Subjects will be excluded if they have asthma, peptic ulcer disease (diseases which may be exacerbated by a histamine analog), or history of pheochromocytoma or peptic ulcer disease. Patients will be excluded if they are prescribed medications known to affect body weight or glucose-lipid metabolism, such as prescription or over the counter medications taken for the purpose of weight reduction. Subjects who are currently treated with metformin, for less than 6 months and have shown recent weight change on metformin. Patients on thyroid replacement therapy or lipid-lowering agents whose dosage has changed by more than 50 % in the past month will be excluded. If they are relatively stable doses of these medications they will not be excluded. Patients who are on lipid lowering medication, thyroid replacement medication, or diabetes medication, (excluding metformin), must remain on these medications throughout the period of the study. Females who are pregnant or breast feeding will be excluded.

['Schizophrenia', 'Schizoaffective Disorder', 'Schizophreniform Disorder', 'Bipolar I Disorder', 'Bipolar II', 'Bipolar NOS(Not Otherwise Specified)', 'Psychotic Disorder Not Otherwise Specified', 'Autism Spectrum Disorder']


Randomized Controlled Trial of Anticoagulation vs. Placebo for a First Symptomatic Isolated Distal Deep-vein Thrombosis (IDDVT)

Summary: CACTUS-PTS is a randomized, placebo-controlled, double-blind study which aims primarily to determine the effectiveness of a 6 week course of therapeutic-dose LMWH (nadroparine) injections vs. placebo in patients with a first symptomatic isolated distal (calf) deep-vein thrombosis (IDDVT), as measured by rate of proximal DVT and symptomatic PE at 6 weeks. Additionally, the study aims to determine if the 6 week course of treatment with therapeutic-dose LMWH (nadroparine) injections, compared to placebo, decreases the frequency of post-thrombotic syndrome (PTS) at 1 year.
Inclusion criteria: inclusion criteria:

 All outpatients with an acute, symptomatic, distal DVT will be included in the study, provided they correspond to the following diagnostic and
Exclusion criteria: , and they have signed an informed consent form.


Comparison of Stenting Versus Best Medical Therapy for Treatment of Ostial Renal Artery Stenosis: a Trial in Patients With Advanced Atherosclerosis

Summary: Renal artery stenosis (RAS) usually refers to a disease of the large extra-renal arterial vessels and most frequently is caused by atherosclerotic obstructions. The prevalence of atherosclerotic RAS increases with age, male gender, traditional cardiovascular risk factors (hypertension, diabetes, smoking, hyperlipidemia) and atherosclerotic comorbidities like coronary artery or peripheral artery disease (PAD). A prevalence up to 40% has been reported in patients with PAD. Undoubtedly, atherosclerotic RAS is a progressive disease, as more than half of the patients exhibit an increasing degree of stenosis within five years after diagnosis, and one out of five patients with a critical stenosis (>60%) suffers renal atrophy and renal failure during this period. RAS may be treated conservatively by so called best medical treatment, surgically, or by endovascular interventions using balloon angioplasty and stenting.~The purpose of the investigators study is to determine the incidence and the predictors of RAS in patients with PAD, and to compare the effect of renal artery stenting versus best medical treatment in patients with hypertension and ostial renal artery stenosis in a randomized controlled trial.
Inclusion criteria: inclusion criteria:

 PAD and unilateral ostial >60% RAS and hypertension

Exclusion criteria: :

 Conditions which imply RAS stenting (bilateral significant renal disease, single functioning kidney, or patients whose conditions cannot be managed medically or by intervention)

 Allergy to contrast agents or medication administered for best medical treatment (in particular ASA and statins)

['Herkulink renal artery Stent', 'best medical therapy']

Herkulink renal artery Stent
best medical therapy