Beta-Blocker Heart Attack Trial (BHAT)

Summary: To determine whether the regular administration of the beta-blocker drug propranolol to people who had had at least one documented myocardial infarction would result in a significant reduction of mortality from all causes over the follow-up period. Eligible volunteer patients were recruited to participate in a double-blind clinical trial within 21 days after the onset of the acute event. One-half of the patients were randomly assigned to a beta-blocking drug (propranolol) and one-half to a placebo. The trial also evaluated the effect of propranolol on incidences of coronary heart disease mortality, sudden cardiac death, and nonfatal myocardial infarction plus coronary heart disease mortality in persons with documented previous myocardial infarction.
Inclusion criteria: Men and women, ages 30 to 69. Documented myocardial infarction.
Exclusion criteria:

['Arrhythmia', 'Cardiovascular Diseases', 'Coronary Disease', 'Death, Sudden, Cardiac', 'Heart Diseases', 'Myocardial Infarction', 'Myocardial Ischemia', 'Ventricular Fibrillation']

Arrhythmia
Cardiovascular Diseases
Coronary Disease
Death
Sudden
Cardiac
Heart Diseases
Myocardial Infarction
Myocardial Ischemia
Ventricular Fibrillation


Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy

Summary: This is a multi-center study to evaluate the safety, pharmacokinetics, and efficacy of belimumab intravenous (IV) in pediatric patients 5 to 17 years of age with active systemic lupus erythematosus
Inclusion criteria: inclusion criteria:

 5 years to 17 years of age at enrollment

 Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria.

 Have active SLE disease (SELENA SLEDAI score ≥ 6).

 Have positive anti-nuclear antibody (ANA) test results.

 Are on a stable SLE treatment regimen at a fixed dose for a period of at least 30 days prior to Day 0.

 Females of childbearing age are willing to use appropriate contraception

 Subject age appropriate assent and parent or legal guardian informed consent to participate

Exclusion criteria: :

 Pregnant or nursing.

 Have received treatment with belimumab (BENLYSTA®) at any time. (BENLYSTA® is a registered trademark of the GSK group of companies.)

 Treatment with any B cell targeted therapy (for example, rituximab) or an investigational biological agent in the past year.

 Have received anti-TNF therapy; Interleukin-1 receptor antagonist; IVIG; or plasmapheresis within 90 days of Day 0.

 Have received high dose prednisone or equivalent (>1.5mg/kg/day) within 60 days of baseline.

 Have received intravenous (IV) cyclophosphamide within 60 days of Day 0.

 Have received any new immunosuppressive/immunomodulatory agent, anti-malarial agent within 60 days of baseline.

 Have severe lupus kidney disease.

 Have active central nervous system (CNS) lupus.

 Have had a major organ transplant.

 Have significant unstable or uncontrolled acute or chronic diseases or conditions not due to SLE.

 Have a planned surgical procedure.

 History of malignant neoplasm within the last 5 years.

 Have required management of acute or chronic infections in the past 60 days.

 Have current drug or alcohol abuse or dependence.

 Have a historically positive test, or test positive at screening for HIV, Hepatitis B, or Hepatitis C.

 Have an IgA deficiency.

 Have severe laboratory abnormalities.

 Have had anaphylactic reaction to X-ray contrast agents or biologic agents.

 Suicidal behavior or ideation.

 Children in Care(CiC): a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.


Knowledge and Perceptions About Human Papillomavirus and Cervical Cancer Risk Among Young Adults

Summary: RATIONALE: Learning about young adults' knowledge and perceptions about risk factors for the human papilloma virus and cervical cancer may help doctors learn more about how to prevent human papilloma virus infection and cervical cancer in the future.~PURPOSE: This clinical trial is studying knowledge and perceptions of the risk factors for human papilloma virus infection and cervical cancer in young adults.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Currently enrolled in a college, university, or community college in the Greater Cleveland metropolitan area

 Currently single and never married

 PATIENT CHARACTERISTICS:

 Not specified

 PRIOR CONCURRENT THERAPY:

 Not specified
Exclusion criteria:

['Cervical Cancer', 'Precancerous Condition']


Combination Therapy for the Treatment of Bipolar Disorders

Summary: This study will compare triple and double drug regimens in the treatment of patients with depression, hypomania, or mania.
Inclusion criteria: inclusion criteria:

 Bipolar I or II Disorder

 Meet criteria for rapid cycling, defined as four or more episodes over the past 12 months

 Meet criteria for a major depressive episode

Exclusion criteria: :

 History of intolerability of lithium, divalproex, or lamotrigine

['Lithium', 'Lamotrigine', 'Divalproex', 'Placebo']


Danish Quality Assurance Project on Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (COPD) in Outpatient Lung Clinics

Summary: Danish Quality Assurance Project on Diagnosis and Treatment of COPD in Outpatient Lung Clinics
Inclusion criteria: inclusion criteria:

 Outpatient with the diagnosis or referral diagnosis of COPD.

 COPD must be the primary reason for this outpatient contact (for both new patients and controls).

Exclusion criteria: :

 Any co-morbidity that hampers the diagnosis and treatment of COPD in accordance with the COPD guidelines used locally (e.g. malignant disease, dementia or sequelae of apoplexy).

 Asthma without the presence of COPD

['Pulmonary Disease, Chronic Obstructive']


Reducing Sleep Disparities in Minority Children

Summary: Inadequate sleep is a major health problem of childhood that often fails to receive attention until significant neurobehavioral and other health problems are noted. Although adequate sleep is essential for normal growth and brain development, studies show that children from minority and economically disadvantaged families are more likely to experience shorter sleep times and more sleep fragmentation compared to their Caucasian and economically advantaged counterparts. As a result, they are disproportionately affected by the adverse health and quality of life consequences of poor sleep. There are currently no intervention studies to the investigators knowledge aimed at addressing sleep disparities by improving sleep duration and sleep hygiene in early school-aged children from minority populations. This study seeks to close the 'sleep gap' that exists between the sleep duration of minority school-aged children and that of their non-minority peers. An interdisciplinary team of researchers and clinicians from Columbia University's Pediatric Lung and Sleep Disorders Center, School of Public Health, Psychiatry Department, and two outpatient clinic systems affiliated with Columbia are collaborating to reduce sleep disparities by improving sleep duration in a group of 5-6 year old minority children. The primary goal of this study is to evaluate the efficacy of a tailored, interactive, educational and behavioral intervention that utilizes trained sleep counselors to assist parents in improving their children's sleep hygiene and reducing risk factors for poor sleep, thereby increasing sleep duration over a 12-month period in a randomized controlled trial of children identified with sleep problems (Aim 1). The investigators will screen 375 parents of 5-6 year old children from 5 primary care clinics to identify children with and without sleep problems and enroll 90 of the 375 children screened who have sleep problems in a randomized controlled trial of an in-home sleep intervention. Using an initial home assessment, baseline actigraphy data, sleep logs recorded by parents, and information regarding risk factors for poor sleep collected from each family during screening, the investigators will work with intervention parents to develop a personalized sleep plan for their children. The investigators will evaluate the effect of the intervention on: a) nightly sleep duration; b) neurocognitive function; and c) behavioral disorders.
Inclusion criteria: inclusion criteria:

 Healthy child age 5-6 years old

 School enrollment for a minimum of 5 hours/day

 Positive Children's Sleep Habits Questionnaire (score ≥ 41)

 Permanent housing for the previous 12 months

 Permission for research staff to complete 5-9 home over 1 year

 Have telephone access or a contact with telephone access

 Fluent in either English or Spanish

Exclusion criteria: :

 Serious co-morbid condition that may impact sleep including:

 genetic syndromes

 neuromuscular disorders

 seizure disorder

 mental retardation

 autism

 severe learning disabilities

 psychiatric disorders

 attention-deficit/hyperactivity disorder

['Sleep Counselor Intervention', 'Sleep Education Control']

Sleep Counselor Intervention
Sleep Education Control


The Therapeutical Role of Continuous Intra-femoral Artery Infusion of Urokinase on Diabetic Foot Ulcers

Summary: Diabetic foot ulcers (DFU) are one of the chronic consequences of diabetes which constitute the most important cause of non-traumatic amputation of the inferior limbs. Patients with diabetes are 22 times more likely to have foot ulceration or gangrene than nondiabetics，while foot ulceration precedes 85% of lower-extremity amputation.~Three factors combine to promote tissue necrosis in diabetic feet: ischemia, neuropathy and trauma. Among them, ischemia peripheral arterial disease may play the important roles in the development of DFU. Moreover, diffuse vascular disease is the main characteristics, and thus it becomes difficult for treatment by using arterial bypass or balloon angioplasty. Therefore, we hypothesized that continuous arterial thrombolysis may be an effective therapy in diabetic foot. The purpose of this study is to investigate the effectiveness and safety of continuous intra-femoral artery injection of urokinase by micro-artery-pump in diabetic ulcers.
Inclusion criteria: inclusion criteria:

 diabetic foot ulcer

 < = 80 years old

 diabetic foot ulcer wegnar 2-4 stage

Exclusion criteria: :

 Wagner grade 0,1 and grade 5

 severe coronary, cerebral, renal vascular as well as severe liver diseases, malignant neoplasms

 bleeding individuals

 > 80 years old

 heart failure (NYHA 3,4)

 cancer

['continuous intra-femoral thrombolysis group', 'Conventional therapy group']


Biomarkers and Early Alzheimer's Disease

Summary: The main goal of this project is to use imaging and biomarkers to identify cognitively normal elderly people who are at increased risk for developing mild cognitive impairment (MCI). MCI is the earliest clinically detectable evidence for brain changes due to Alzheimer's disease (AD). The second goal of this project is to describe the inter-relationships among anatomical biomarkers, cerebrospinal fluid biomarkers, and cognition measures in those elderly people who develop MCI.
Inclusion criteria: inclusion criteria:

 Individuals of either sex, with a high school education, and between the ages of 60 and 80 years living in the New York City metropolitan area.

 Minimum of 12 years education.

 Participants will be classified as within normal limits on medical, psychiatric and neuropsychological examinations (performance that is better than -1.5 sd of the NYU norm based WMS-R delayed memory index).

 Participants will have a global deterioration scale (GDS)=1 or 2. Those enrolled in the High-Risk group will have a GDS=2 and have a score of >25 on the Memory Complaint Questionnaire (MCQ). In high risk memory loss cases, an informed family member or caregiver will be interviewed to confirm that the participant can perform specific tasks.

Exclusion criteria: :

 Past history or MRI evidence of brain damage including significant trauma, stroke, hydrocephalus, lacunar infarcts, seizures, mental retardation or serious neurological disorder.

 Significant history of alcoholism or drug abuse.

 History of psychiatric illness (e.g., schizophrenia, mania, Post-Traumatic Stress Disorder [PTSD], or depression).

 Any focal neurological signs or significant neuropathology.

 A score of 4 or greater on the Modified Hachinski Ischemia Scale, indicative of cerebrovascular disease.

 A total score of 16 or more on the Hamilton Depression Scale to exclude possible cases of primary depression.

 Evidence of clinically relevant and uncontrolled hypertensive, cardiac, pulmonary, vascular, metabolic or hematologic conditions.

 Physical impairment of such severity as to adversely affect the validity of psychological testing.

 Hostility or refusal to cooperate.

 Any prosthetic devices (e.g., pacemaker or surgical clips) that could be affected by the magnetic field employed during MRI imaging.

 History of familial early onset dementia.


Survey of Non-Variceal Upper Gastro Intestinal Bleeding in Vietnamese Patients

Summary: The main aim of the study is to describes the outcomes of patients with Upper Gastrointestinal Bleed (UGIB) in a real-life setting. Additionally analyse assessed predictors of outcome, including the impact of hemostatic endoscopic and pharmacologic therapies.
Inclusion criteria: inclusion criteria:

 Adult patients (>=18yrs) admitted to the hospital, or inpatients admitted for another reason, presenting with overt non-variceal upper GI bleed manifesting as hematemesis/coffee ground vomiting, melena, hematochezia...

 Evidence that an upper GI endoscopy was performed

Exclusion criteria: :

 GI bleeding not from NVUGIB


Tai Chi Training for Elderly People With Chronic Heart Failure

Summary: Physical activity is recommended in the treatment of heart failure. Elderly people demand various forms of physical activity. Tai chi has shown to be an appreciated form of physical activity among elderly, although there is a lack of studies focusing people aged 70 years and older.~The overall goal with the project is to find a form of physical activity that is safe and free from side effects, suitable for elderly people with chronic heart failure. The hypothesis is that for patients participating in tai chi training during three months the degree of self rated fatigue will be reduced and health-related quality of life will increase, compared with a control group receiving ordinary care. The primary aim is to study the effect of tai chi training on fatigue and health-related quality of life. A second aim is to study effects on physical function and levels of brain natriuretic peptide (BNP) in blood plasma. A tertiary aim is to describe the experience of participating in tai chi training.~A mixed methods study is conducted. Fortyfive patients with a verified diagnosis of heart failure in the age of 70 years or older, who experience fatigue according to the Multi Fatigue Inventory (MFI-20), was randomized to intervention or control group. Three groups with 8-9 participants each completed a tai chi training programme twice-weekly for 16 weeks. Data was collected at baseline, directly after the 16 weeks of training, and 6 and 12 months thereafter. The programme is worked out by an expert in Chinese traditional medicine to suit elderly people with chronic heart failure, and the classes were led by experienced leaders. Before the start of the study a small pilot study was conducted to test the feasibility of the programme. A group of seven patients completed the programme for eight weeks without any problems.~If tai chi has a good effect on fatigue, health-related quality of life and physical function, this form of physical activity can be a valuable complement to other medical treatment. Tai chi has a potential to be offered to many patients to a relatively low cost. It can be practiced in groups or in private, and also through internet connection.
Inclusion criteria: inclusion criteria:

 Verified diagnosis of heart failure

 Left ventricle ejection fraction < 50

 Stable medical treatment with Angiotensin Converting Enzyme blockers and Betareceptor blockers (if no contraindications) experience of fatigue according to the Multidimensional Fatigue Inventory

 70 years or older

 Swedish speaking

Exclusion criteria: :

 Instable angina pectoris

 Myocardial infarction within the last three months

 Cognitive impairment

 No experienced fatigue


1-Octanol to Treat Essential Tremor

Summary: This study will evaluate the safety and effectiveness of the food additive 1-octanol for treating essential tremor. This disorder, which is an involuntary shaking, usually of the hands, has no satisfactory treatment. It affects more than one of every 100 people in the general population, with the figure climbing to nearly 4 in every hundred among people over 40 years old. In animal studies, 1-octanol reduced chemically induced tremors in rats. This study will test the effects of the accepted daily intake of 1-octanol (1 milligram per kilogram of body weight) on essential tremor in humans.~Patients with essential tremor 21 years old and older who wish to enroll in this study will undergo eligibility screening with a medical history and physical examination that includes tests for thyroid, liver and kidney problems. Participants will be randomly assigned to receive either 1-octanol or a placebo (an inactive substance). Patients in both groups will have an intravenous catheter (a thin, plastic tube) placed in an arm vein for collecting blood samples during the study. Those in the 1-octanol group will be given a 1-octanol capsule; the placebo group will receive a look-alike capsule containing no active ingredient. Neither the patient nor the doctor will know which patients are taking 1-octanol or placebo until the end of the study.~Tremors will be measured once before the catheter is placed, every 15 minutes during the first 2 hours after taking the capsule, twice during the third hour (30 minutes apart), and once again after 5 hours. The tremors are measured using procedures called accelerometry and surface electromyography. For these procedures, electrodes are taped to the skin; needles are not used. Blood samples will be collected once before taking the capsule, every 15 minutes for the first hour and a half after taking the capsule and again at 2 hours, 4 hours and 5 hours after taking the capsule. Vital signs (blood pressure, pulse, and respiratory rate) will be measured every 15 minutes during the first 2 hours of taking the capsule, every 30 minutes during the third hour, and again at 4 hours and 5 hours.~Participants will stay in the hospital overnight for observation and return after 3 days for a follow-up physical examination, including a blood test.
Inclusion criteria: Patients with essential tremor affecting the upper limbs who are 21 years of age or older.

 Patients who are not taking medications for essential tremor or any other medical condition for at least 2 weeks.

 Patients who have not consumed alcohol or cold medications containing alcohol for at least 24 hours prior to the day of the study.

 Women must not be pregnant or lactating. Women of childbearing age must use birth control while participating in this study.

 Patients must not have any neurological disease other than tremor (e.g., Parkinson's disease).

 Patients must not have evidence of thyroid, liver, kidney or chronic lung disease.
Exclusion criteria:


Achilles Tendon Lengthening in Patients With Diabetes to Prevent Foot Ulcers

Summary: People with diabetes often develop severe skin problems (ulcers) on their feet. Sometimes these are treated with surgery and other times by temporarily immobilizing the foot in a cast. This study compares the effect of surgery to lengthen the Achilles tendon and put the foot in a cast, to using a cast alone. The study will also examine how foot strength, joint movement, and overall ability to walk, balance and climb stairs is affected.
Inclusion criteria: inclusion criteria:

 History of Diabetes Mellitus

 Limitation of dorsiflexion ankle range of motion to zero degrees or less

 Recurrent or nonhealing ulcer (Grade II, Wagner scale)

Exclusion criteria: :

 Nonambulatory patients or those that would not benefit from the Achilles lengthening procedure.

 Patients with a history of CVA or other significant neurological problems complicating their rehabilitation.

 Patients with a history of midfoot or hindfoot Charcot fractures.

 Patients with an Ankle-Arm index < 0.45 or absolute toe pressure < 40 mm Hg.

 Patients medically unfit for the anesthesia required for this Achilles lengthening procedure.

['Diabetes Mellitus', 'Foot Ulcer', 'Peripheral Neuropathy']

Diabetes Mellitus
Foot Ulcer
Peripheral Neuropathy


Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous Nephritis

Summary: The investigators study the efficacy and safety of tacrolimus in the treatment of membranous nephritis secondary to systemic lupus erythematosus.
Inclusion criteria: inclusion criteria:

 Fulfill the revised American College of Rheumatology criteria for SLE

 Have biopsy-proven membranous nephropathy secondary to SLE

 Nephrotic syndrome with proteinuria (> 3 g/day) and serum albumin < 30 g/dl, with or without active urinary sediments despite steroid therapy (with or without cytotoxic agents)

 Age over 18 with informed consent

 Female patients of child-bearing age and male patients who agree to maintain effective birth control practice during the study

Exclusion criteria: :

 Patient with abnormal liver function tests

 Patient with hepatitis B surface antigen or who is hepatitis C antibody positive

 Patient who is diabetic

 Patient who is receiving non-steroidal anti-inflammatory drugs (NSAIDs) or other agents known to influence urinary protein excretion

 Patient is allergic or intolerant to macrolide antibiotics or tacrolimus

['Lupus Nephritis', 'Lupus Erythematosus, Systemic']

Lupus Nephritis
Lupus Erythematosus
Systemic


Efficacy and Safety Study of Intravenous Belimumab Versus Placebo in Subjects With Idiopathic Membranous Nephropathy

Summary: The main clinical study will be a randomized, double-blind, placebo-controlled, long term study involving a 100 week treatment period. The purpose of this study is to test for superiority of treatment with belimumab 10 mg/kg plus supportive therapy compared to placebo plus supportive therapy in idiopathic membranous nephropathy (IMN). The purpose of this study is also to investigate the effect of initiating earlier treatment with belimumab compared to delayed treatment with current immunosuppressive treatment regimens. The study will also determine the pharmacokinetic (PK) profile of belimumab and further explore the mechanism of action of Belimumab as well as effects on quality of life. All subjects (on either active treatment or placebo) will receive background supportive therapy throughout the main clinical study, which includes angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin receptor blockers (ARBs) unless contraindicated and may include statins, diuretics, dietary salt restriction but excludes immunosuppressants (except low dose corticosteroids). Screening will be done within 5 to 2 weeks before the first scheduled dose of study treatment. A total of 94 evaluable subjects will be randomized in a 1:1 ratio such that 47 subjects receive intravenous belimumab 10 mg/kg and 47 receive intravenous placebo. Subjects will be dosed on Days 0, 14, 28 and then every 4 weeks through to, and including, Week 100, resulting in a total of 27 doses (giving 104 weeks of drug exposure). The dosing frequency will be adjusted to every 2 weeks if the subject's proteinuria as assessed by urinary protein creatinine ratio (PCR) is greater than 1000mg/mmol (greater than 10 g/24 h), to compensate for loss of belimumab in the urine. Subjects who are withdrawn from study treatment at any time during the study, eg for rescue therapy, will participate in follow-up visits every 12 weeks up to week 104. A subject will be regarded as having completed the main clinical study if they complete all phases of the main clinical study (screening, treatment period, 4 week and 16 week post last dose short term safety follow-up). Subjects who complete the main clinical study will therefore participate in the main clinical study for approximately 28 months. After the main clinical study, there will be a 5 year (long term) follow-up phase to assess long term outcomes.
Inclusion criteria: inclusion criteria:

 Age & Gender: Male or female between 18 and 75 years of age inclusive, at the time of signing the informed consent.

 Histological diagnosis: Have clinical diagnosis of IMN, as verified by biopsy (either by light microscope with immuno-fluorescence, or by electron microscope) in the last 3 years (biopsy results [and slides where possible] should be available for independent evaluation). For patients with relapsed disease, a biopsy should be available within the preceding 7 years.

 Proteinuria: Have clinically active disease (nephrotic range proteinuria) for at least 3 months prior to screening and no improvement (<30% reduction), despite supportive therapy (which must include maximal tolerated doses of ACE inhibitor or ARB unless contraindicated, and may include statins, diuretics, dietary salt restriction). During screening proteinuria must be >400 mg/mmol by uPCR (or >4.0 g per 24 hrs) as measured from a 24 hrs urine collection and/or spot urine sample (early morning where possible) on 2 occasions at least 7 days apart.

 Proteinuria in patients with relapsed disease: Patients who previously achieved proteinuria <2 g per 24h for at least 6 months and have subsequently relapsed with proteinuria levels as documented above, may be eligible providing recurrence has been within the previous 3 years and patient is known to be anti-PLA2R positive.

 Female Subject is eligible to participate if she is not pregnant or nursing; is non-childbearing potential. Females of child-bearing potential must agree to use one of the approved contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimise the risk of pregnancy at that point. Female subjects must agree to use contraception until 16 weeks after the last dose.

 French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

 inclusion criteria for Long Term Follow-up: Subjects who have signed informed consent for the Long Term Follow-up and have completed 2 years study treatment and the 16 week follow-up visit, or who have withdrawn early from study treatment but completed the Week 104 Withdrawn visit.

Exclusion criteria: :

 Non-Idiopathic MN or other condition affecting the kidney: If the diagnosis of MN is secondary to other conditions, or the subject has renal impairment from a condition that is not MN. Causes of secondary MN include (but are not limited to) Immune diseases (Systemic lupus erythematosus, diabetes mellitus; rheumatoid arthritis, Hashimoto's disease, Grave's disease, mixed connective tissue disease, Sjogren's syndrome, primary biliary cirrhosis, bullous pemphigoid, small bowel enteropathy syndrome, dermatitis herpetiformis, ankylosing spondylitis, graft-versus-host-disease, Guillain-Barre syndrome); or Infectious or parasitic diseases (Hepatitis B; Hepatitis C, syphilis, filariasis, hydatid disease, schistosomiasis, malaria, leprosy); or Drugs and toxins (Gold, penicillamine, non-steroidal anti-inflammatory agents, mercury, captopril, formaldehyde, hydrocarbons, bucillamine); or Miscellaneous(Tumors excluded with reasonable diligence, renal transplantation, sarcoidosis, sickle cell disease, Kimura disease, angiofollicular lymph node hyperplasia).

 Anti-PLA2R autoantibody: Patients known to be negative for anti-PLA2R autoantibody.

 Severely reduced or deteriorating kidney function: An eGFR at screening <40 mL/min/1.73m^2 (as determined by 4 variable version MDRD equation) or kidney function not stable (as defined by >15% decrease in eGFR in 3 months before screening unless due to medication change).

 Blood Pressure: Uncontrolled hypertension defined as blood pressure (BP) >150/90 mmHg (treatment target <=140/80)

 Prior Therapy: Have received treatment with the following therapies at the times specified prior to Day 0: Therapy - B-cell targeted therapy except rituximab (e.g., other anti- CD20 agents, anti-CD22 [epratuzumab], anti-CD52 [alemtuzumab], BLyS-receptor fusion protein [BR3], TACI Fc, or belimumab), Time period: anytime; Therapy: Rituximab (subjects with rituximab treatment between 1 and 2 years prior to Day 0 are eligible if there is documented evidence of B-cell repopulation to >50% of pre-treatment levels), Period: 2 years; Therapy: Abatacept and any other biologic investigational agent other than B cell targeted therapy (i.e. not approved for sale in the country in which it is being used), Time Period: 364 days; Therapy: Cyclophosphamide or chlorambucil 3 or more courses of systemic corticosteroids for concomitant conditions (e.g., asthma, atopic dermatitis). (Topical or inhaled steroids are permitted.), Time Period: 180 days; Therapy: Anti-tumour necrosis factor (TNF) or anti-IL-6 therapy (e.g. adalimumab, etanercept, infliximab, tocilizumab). Interleukin-1 receptor antagonists (e.g. anakinra). Other immunosuppressive/immunomodulatory agents (e.g azathioprine, 6-mercaptopurine, mycophenolate mofetil (PO)/ mycophenolate mofetil hydrochloride (IV), mycophenolate sodium (PO), methotrexate, tacrolimus, sirolimus, thalidomide, leflunomide, mizoribine, ciclosporin). Intravenous immunoglobulin (IVIG). Plasmapheresis, leukapheresis, Time Period: 90 days; Therapy: A non-biologic investigational agent (i.e. not approved for sale in the country in which it is being used). Intravenous corticosteroid, Adrenocorticotropic hormone (ACTH). Aliskiren. A change in dose of >50% for angiotensin pathway antihypertensive (e.g., ACE inhibitor, angiotensin receptor blocker), Time Period: 60 days; Therapy: A live vaccine. Greater than 30mg/day corticosteroid, Time Period: 30 days; Therapy: Greater than 10mg/day corticosteroid. A change in dose of a corticosteroid. Note: Changes to inhaled steroids and new topical immunosuppressive agents (e.g., eye drops, topical creams) are allowed, Time Period: 14 days.

 Transplantation: Have a history of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.

 Cancer: Have a history of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix.

 Acute or chronic infection: Have required management of acute or chronic infections such as currently on any suppressive therapy for a chronic infection such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria); or hospitalisation for treatment of infection within 60 days prior to Day 0; or use of parenteral (IV or IM) antibiotics (anti-bacterials, anti-virals, anti-fungals, or anti-parasitic agents) within 60 days prior to Day 0.

 Liver disease: Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).

 Other diseases/conditions: Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to IMN (i.e., cardiovascular, pulmonary, haematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk; or have a planned surgical procedure or a history of any other medical disease (e.g. cardiopulmonary), laboratory abnormality, or condition (e.g., poor venous access) that, in the opinion of the investigator, makes the subject unsuitable for the study.

 Positive serology: Have a historically positive HIV test or test positive at screening for HIV. Serologic evidence of Hepatitis B (HB) infection based on the results of testing for HBsAg, anti-HBc and anti-HBs. Positive test for Hepatitis C antibody confirmed on the same sample with a Hepatitis C RIBA immunoblot assay if available.

 Liver function tests: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >=2x upper limit of normal (ULN); alkaline phosphatase and bilirubin >1.5xULN (isolated bilirubin >1.5ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

 Immunodeficiency: Have an IgA deficiency (IgA level < 10 mg/dL) or have IgG level <250 mg/dL and have previously received any non-glucocorticoid immunosuppression during the previous 6 months.

 Laboratory test abnormalities: Have clinically significant abnormalities in screening laboratory assessments (not related to the disease), as judged by investigator.

 Drug sensitivity / Anaphylaxis: History of sensitivity or intolerance to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. History of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.

 Suicidality: Subjects who have evidence of serious suicide risk including any history of suicidal behaviour in the last 6 months and/or any suicide ideation of type 4 or 5 on the Columbia Suicide-Severity Rating Scale (C-SSRS) in the last 2 months or who in the investigator's judgement, pose a significant suicide risk.

 Substance abuse: Evidence of current drug or alcohol abuse or dependence.

 Blood donation: Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.


Warm Humid Gas Insufflation for Appendix Removal by Minimally Invasive Surgery Warm Humid Insufflation for Appendix Removal by Minimally Invasive Surgery Trial (WARMIST)

Summary: In laparoscopic (key-hole) surgery, the use of cold dry carbon dioxide gas to inflate the abdominal cavity for the creation a clear operating field, results in damage to the cavity lining, known as the peritoneum. This has been associated with negative effects on post-operative recovery. Adult studies using warm humidified insufflation gas have indicated possible decreased post-operative pain, reduced narcotic analgesia requirements, decreased fogging of the laparoscopic camera lens, and reduced time to return to normal activities. Cold dry gas during laparoscopic surgery also has potential to cause abnormal decrease in body core temperature (hypothermia). This has been established by trials in adult humans and animal models. The WARMIST study aims to investigate for whether warm humid gas insuflation during laparoscopic removal of the appendix in children reduces intraoperative temperature variations, post-operative pain (indicated by morphine usage and pain scores), length of hospital stay and degree of camera lens fogging, and speed post-operative recovery compared to using cold dry gas insufflation.
Inclusion criteria: inclusion criteria:

 Healthy volunteers aged 8-14 years presenting to Starship Children's Hospital (Auckland, New Zealand) within the study period diagnosed clinically with acute appendicitis requiring diagnostic laparoscopy +/- appendicectomy.

Exclusion criteria: :

 Consent to participate in study not obtained, partial or total blindness, unable to speak and read sufficient English, presence of any abdominal prostheses, diagnosis of mental retardation, developmental delay, neuromuscular impairment, attention-deficit disorder, chronic pain, or psychiatric illness, immunosuppression, allergy to morphine, and history of previous abdominal surgery

['Fisher and Paykel Insuflow (MR 860) Surgical Humidification Device', 'Laparoscopic Appendicectomy', 'Laparoscopic Appendicectomy']

['Peritoneal Dessication Damage and Inflammation', 'Peri-operative Hypothermia']


Evaluating the Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis

Summary: This study seeks to evaluate whether the routine, primary use of the spring-loaded silo (SLS) to treat infants with gastroschisis will result in improved outcomes, faster recovery times and fewer post-surgical complications than the standard selective use of the silo.
Inclusion criteria: inclusion criteria:

 Diagnosis of Gastroschisis

 Birth Weight ≥ 1500 grams

 Gestational Age ≥ 34 weeks

Exclusion criteria: :

 Birth Weight < 1500 grams

 Gestational Age < 34 weeks

 Presence of Bowel Ischemia or Necrosis

 Abdominal wall defect too small

 Major associated anomalies or medical condition

 Presence of Intracranial Hemorrhage (grade IV)

 Parent Refusal for Randomization

['Primary placement of a spring-loaded silo', 'Primary Closure']


A Multicenter Study to Evaluate the ROX Anastomotic Coupler System (ACS) In Patients With Severe Hypertension

Summary: The purpose of this study is to evaluate the safety and performance of the ROX Anastomotic Coupler System (ACS) in patients with severe hypertension.
Inclusion criteria: inclusion criteria:

 Diagnosis of severe hypertension must be made on the basis of current findings, medical history, and physical examination

Exclusion criteria: :

 Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study.

['ROX ANASTOMOTIC COUPLER SYSTEM (ACS)', 'ROX Anastomotic Coupler System (ACS)']

ROX ANASTOMOTIC COUPLER SYSTEM (ACS)
ROX Anastomotic Coupler System (ACS)


Efficacy of Chinese Ocular Exercise on Visual Acuity and Ocular Accommodation in Myopic Teenager

Summary: To assess whether Chinese ocular exercise is effective in altering distant and near visual acuity, ocular accommodation and visual symptoms in myopic teenager, and thus might have the possibility of slowing myopia progression in teenager through a weak but long-term effect.
Inclusion criteria: inclusion criteria:

 Visual acuity: 20/20 or better in each eye;

 Spherical error ranging from +0.5 D to -6.0 D and astigmatism less than 1.5 D in each eye, anisometropia less than 1.0 D between the two eyes Contact lens

 No strabismus, amblyopia and any other ocular or systematic diseases that may affect refractive development

Exclusion criteria: :

 Currently using other interventions to control myopia progression (acupuncture, massage, drugs, ear needles and so on)

 Unable to cooperate with the ocular examination and questionnaire survey


Moletest Clinical Study in Scotland

Summary: To evaluate an iPad based photoimage analysis system (Moletest) for improving discrimination of benign from malignant suspicious skin lesions or moles. Specifically the objective is to demonstrate that the Moletest system is able with a sufficient degree of confidence (95%) to identify lesions which are benign
Inclusion criteria: inclusion criteria:

 All patients referred to the Dermatology Department, Lanarkshire Hospitals during a period to be defined for assessment of suspicious skin lesions (cutaneous moles) will be eligible for inclusion in the study. There are no age limits but patients under the age of 18 years will also have their inclusion subject to parental/guardian consent

Exclusion criteria: :

 There is no exclsion criteria


Paracetamol Effect on Oxidative Stress and Renal Function in Severe Malaria

Summary: Blackwater fever, characterized by intravascular haemolysis and hemoglobinuria, is an important cause of renal impairment and mortality in severe malaria caused by Plasmodium falciparum. The largest malaria clinical trials report blackwater incidences of 5-7% in Asian adults and 4% in African children with severe malaria treated with artesunate or quinine. The prevalence of blackwater fever in Chittagong, Bangladesh is 15% with associated rates of renal failure and mortality of 42.9% and 14.2% respectively.~The fundamental characteristic of blackwater fever is the presence of intravascular hemolysis of both infected and uninfected erythrocytes and release of free haemoglobin. The cytotoxic free haemoglobin present can cause severe oxidative damage as a result of haem redox cycling yielding ferric and ferryl heme, which generate radical species that induce lipid peroxidation and subsequent production of F2-isoprostanes (F2-IsoPs). Evidence suggests that F2-IsoPs generated by the hemoprotein-catalyzed oxidation of lipids are responsible for the oxidative damage and vasoconstriction associated with renal injury in haemolytic disorders and rhabdomyolysis.~A novel mechanism of paracetamol was recently demonstrated, showing that paracetamol is a potent inhibitor of hemoprotein-catalyzed lipid peroxidation by reducing ferryl heme to its less toxic ferric state and quenching globin radicals. In a recent proof of concept trial, paracetamol at therapeutic levels was shown to significantly decrease oxidant kidney injury, improve renal function and reduce renal damage by inhibiting the hemoprotein-catalyzed lipid peroxidation in a rat model of rhabdomyolysis-induced renal injury. Since adults with severe malaria demonstrate increased concentrations of cell-free haemoglobin, and urinary F2-IsoPs, the investigators hypothesize that this novel inhibitory mechanism of paracetamol may provide renal protection in this population by reducing the hemoprotein-induced lipid peroxidation. As there is currently no consensus that exists concerning adequate medical treatment for blackwater fever, the potential application of this safe and extensively used drug would be of great benefit.
Inclusion criteria: inclusion criteria:

 Patient age >12 years

 Presence of severe or moderately severe P. falciparum malaria, with and without blackwater fever, confirmed by positive blood smear with asexual forms of P. falciparum

 Temperature >38 degrees Celsius on admission or fever during the preceding 24hours

 Written informed consent from patient or attending relative able to and willing to give informed consent. Consent form and information sheets will be translated into Bangla and copies provided to the patient.

Exclusion criteria: :

 Patient or relatives unable or unwilling to give informed consent

 History of chronic liver disease

 History of alcohol use (>3drinks per day)

 Contraindication or allergy to paracetamol or artesunate therapy

 Contraindication to nasogastric tube insertion i.e. facial fracture, bleeding diathesis

 Pregnancy


Understanding Sleep Problems in Children With Autism Spectrum Disorder

Summary: The investigators will examine whether sleep problems in children with autism spectrum disorder (ASD) are related to alterations in the production of melatonin (MT), a hormone that plays an important role in regulating sleep-wake cycle. Children with ASD experience high rates of sleep disturbances that potentially contribute to problems with thinking and behavior. It is unclear if changes in MT production cause sleep problems in children with ASD. MT is frequently used to treat these sleep problems; however, it has not been well established whether MT is an effective treatment. Our hypotheses concerning MT is children with ASD and sleep problems will have a delayed sleep-wake cycle and/or decreased MT production. This study will compare children diagnosed with ASD to healthy control children with no ASD diagnosis. All subjects will be recruited from one of three sites: Baylor College of Medicine, Oregon Health & Science University and Columbia University. The investigators will use a standardized questionnaire to determine whether the child has sleep problems. The investigators will measure MT levels in saliva in ASD children with sleep problems and in a group of control children without sleep problems. Total 24-hour MT production will be determined from urine samples in these same two groups.
Inclusion criteria: inclusion criteria:

 Diagnosis of Autism Spectrum Disorder; supported by ADOS and the ADI or SCQ (subjects).

 Age greater than or equal to 4 or less than or equal to 9 years;

 Parents have given informed consent.

 Parent/Caregiver fluent in written and spoken English.

 Controls only: A SCQ score of less than 10 without parental or physician concern for another neurodevelopmental disorder will be used to define normal children.

Exclusion criteria: :

 Current use of psychoactive medications (e.g. fluoxetine, methylphenidate, risperidone, lithium, etc.)*;

 Current or use within the last 1 month of beta-blockers or melatonin;

 Current use of sleep aids;

 Presence of untreated medical problems that could otherwise explain sleep problems (e.g. obstructive sleep apnea, gastroesophageal reflux disease - GERD);

 Blindness.

 Controls only: current or past diagnosis of ADHD, depression, anxiety or with any other psychiatric conditions. (7) Controls only: Sibling has a diagnosis of Autism Spectrum Disorder.

 Psychoactive medications can be discontinued but the parents must discuss medication discontinuation with their prescribing physician prior to reducing or stopping the medications.


Stereotactic Radiotherapy (SBRT) of Lung Metastasis

Summary: The purpose of this institutional protocol is to offer SBRT to selected patients in a controlled environment to refine treatment techniques (including dose/fractionation schedules) and standardize follow-up. SBRT has been in clinical use for over a decade in some institutions and the available data suggest that it can be used safely and with good results. This study will see how effective Stereotactic Body Radiation Therapy is for treating tumours in the lung and how often people have side effects. Radiation therapy is usually given once a day, often for a few weeks. In this study, study participants will receive high doses of radiation treatment to tumours in the lung for 3 to 10 treatment sessions over a total of about 1 to 2 weeks.~Several reports indicate that this therapy might shrink tumours and control the cancer for extended periods of time. Although specialists started to treat patients with SBRT over 10 years ago, it is still used in relatively few cancer centres.
Inclusion criteria: inclusion criteria:

 Histological confirmation of malignancy, unless the risks of biopsy are unacceptable and the lesion has grown on serial CT scan and/or is PET positive.

 Eligible patients must have staging studies (e.g. chest radiograph, CT scan, MRI/CT Brain/Bone Scan) identifying them as:

 patients with stage I or II, non-metastatic NSCLC (T1, N0, M0; T2, N0, M0; or T3, N0, M0 chest wall primary tumors only)

 patients with a non-lung primary that is controlled and which has metastasized to the lungs alone, in whom potentially curative surgery would otherwise be an option (e.g. colorectal, breast, sarcoma…etc)

 the subset of patients with limited (low) volume metastatic NSCLC or other primary site tumors whom it is felt may derive benefit from highdose SBRT treatment to the primary or metastatic lung tumor. And in whom other sites of metastatic disease are being treated with the desire to achieve long term control. Lesions must meet size criteria in 4.1.2.1

 Patients who have potentially resectable disease should be considered medically inoperable, or else in the judgement of the thoracic surgeon and lung team, surgery is not considered the preferred management option

 Early stage lung cancer: ≤3 parenchymal lung lesions, Metastatic disease to lungs: ≤5 parenchymal lung lesions

 Patients with early stage primary NSCLC should have hilar or mediastinal lymph nodes that are considered N0 on clinico-radiological grounds (i.e. no clinico-radiological evidence of lymph node spread)

 In patients with early stage primary NSCLC and a co-existing malignancy, the co-existing malignancy must have an expected prognosis better than primary lung lesion

 Adequate lung function to tolerate the planned stereotactic radiation

 Previous conventional RT to mediastinum/lung allowed as long as SBRT is not expected to have a high probability of impairing lung function

 Must be ≥ 18 years of age

 Zubrod performance status must be between 0 and 3

 Women of child bearing potential and male participants must use an effective contraceptive method

 Willing and able to give informed consent

Exclusion criteria: :

 Patients with active systemic, pulmonary or pericardial infection

 No concurrent systemic therapy (chemotherapy, immunotherapy or biological therapy), apart from hormone therapy, is allowed

 History of active auto-immune diseases, including systemic lupus erythematous, rheumatoid arthritis, C.R.E.S.T., systemic sclerosis,scleroderma

 Potential candidate for concurrent chemo-radiation therapy

 Patient enrollment on other studies may be permissible. This will depend on patient and study characteristics.

['Non-small Cell Lung Cancer', 'Metastasis From Other Cancers']

Non-small Cell Lung Cancer
Metastasis From Other Cancers


Escitalopram in Bipolar Depression: a Placebo-controlled Study of Acute and Maintenance Treatment

Summary: Funding: An investigator-initiated trial funded by H. Lundbeck AS.~Study design: Prospective, randomised, placebo-controlled parallel-group multicenter study.~Aim: To investigate efficacy and side effects (especially mood switches) of escitalopram,a selective serotonin reuptake inhibitor, in the acute and maintenance treatment of bipolar depression.~Hypotheses:~Escitalopram, given in addition to mood stabilising medications, is significantly more efficacious, measured by response and remission rates than placebo in bipolar depression (the acute phase study).~Continuation therapy with escitalopram gives significantly longer mean time to depressive relapse and fewer depressive relapses compared to placebo (the continuation study).~The incidence of mood switching (defined as development of mixed episodes, mania, or hypomania according to DSM-IV criteria) do not differ significantly between escitalopram and placebo in either the acute or the continuation phases.~Patients: In- and outpatients receiving care in the specialised psychiatric services of Western Norway. The population is intended to be representative of the patients treated for bipolar depression in ordinary specialist care. Patients must have a MADRS score of at least 20 at baseline. Patients with ongoing substance abuse or dependence, organic mental illness, and non-affective psychotic symptoms are excluded.~Medication: Escitalopram 10-20 mg daily or placebo in addition to mood stabilisers. The dose of mood stabilisers must have been constant for the last six weeks prior to randomisation.~Method: Phase 1 is a eight-week acute treatment trial with six clinical assessments. Patients treated with escitalopram who have not responded after eight weeks (defined by at least 50% reduction of MADRS score compared to baseline) leave the study. Placebo non-responders are treated openly with escitalopram and repeat phase 1. Responders are re-randomised to 32 weeks of maintenance treatment (phase 2). Phase 2 has nine clinical assessments. Patients who develop hypomania, mania or depressive episodes (defined as episodes meeting DSM-IV criteria for Major Depressive Episode with MADRS scores of at least 20 points) leave the study in this phase. Patients leaving the study prematurely will be offered alternative treatment.
Inclusion criteria: inclusion criteria:

 Patients with bipolar disorder in major depressive episode according to DSM-IV

 MADRS score of at least 20 points at screening and baseline

 18-70 years of age

 Unchanged dose of mood stabilising medication for at least six weeks prior to inclusion

 Voluntary, informed and written consent

Exclusion criteria: :

 Non-affective psychotic symptoms at screening

 Pregnancy or breast-feeding

 Fertile women without appropriate contraception (the pill, IUD, or contraceptive injection)

 Substance dependence during the last three months prior to baseline

 Mental retardation and organic brain disorders

 Suicide risk that mandates specific measures

 Novel (within three months) or unstable medical conditions

 Clinically significant abnormal results on medical examination or blood samples

 Exposure to escitalopram during the last three months

 Allergic reactions to citalopram or escitalopram

 Anorexia nervosa with body mass index below 18

 Formal psychotherapy started within six weeks of screening

 Electroconvulsive therapy (ECT) during the current episode of depression

 Patients who are unlikely to be reliable and compliant with study procedures

 Patients who are not fluent in Norwegian


Effect of Gamma Tocopherol Enriched Supplementation on Response to Inhaled LPS

Summary: To test the hypothesis that gamma tocopherol (vitamin E) supplement inhibits endotoxin induced airways inflammation in allergic asthmatics
Inclusion criteria: inclusion criteria:

 Age 18-50 of both genders

 Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy

 History of episodic wheezing, chest tightness, or shortness of breath consistent with asthma, or physician diagnosed asthma.

 Positive methacholine test. A positive test is defined as a provocative concentration of methacholine of 10 mg/ml or less producing a 20% fall in Forced Expiratory Volume in 1 second (FEV1) (PC20 methacholine) by the method used in a separate screening protocol.

 FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .70 (without use of bronchodilating medications for 12 hours or long acting beta agonists for 24 hours), consistent with lung function of persons with no more than mild episodic or mild persistent asthma.

 Allergic sensitization to at least one of the following allergen preparations: (House Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1, Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive immediate skin test response.

 Symptom Score (this will be submitted as an attachment) no greater than 16 (out of a possible 24) for total symptom score with a value no greater than 3 for any one score. No more than one score may be greater or equal than 3.

 subjects must be willing to avoid caffeine for 12 hours prior to all visits.

Exclusion criteria: :

 Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes, chronic renal disease, chronic thyroid disease, history of chronic infections/immunodeficiency, history of tuberculosis

 Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months

 Moderate or Severe asthma

 Exacerbation of asthma more than 2x/week which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma.

 Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current National Heart, Lung and Blood Institute (NHLBI) guidelines for diagnosis and management of asthma. (Not to include prophylactic use of albuterol prior to exercise).

 Viral upper respiratory tract infection within 2 weeks of challenge.

 Any acute infection requiring antibiotics within 2 weeks of exposure or fever of unknown origin within 2 weeks of challenge.

 Severe asthma

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

 Medications which may impact the results of the Clinical Center Reference Endotoxin (CCRE) exposure, interfere with any other medications potentially used in the study (to include steroids, beta antagonists, non-steroidal anti-inflammatory agents)

 Any history of smoking in the year prior to study enrollment; lifetime smoking history > 10 pack years

 Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma

 Allergy/sensitivity to study drugs, including E coli, or their formulations.

 Known hypersensitivity to methacholine or to other parasympathomimetic agents

 History of intubation for asthma

 Unwillingness to use reliable contraception if sexually active (Intrauterine device, birth control pills/patch, condoms).

 Abnormal Prothrombin Time (PT) or Partial Thromboplastin Time (PTT) values at screening or during the treatment period. Normal values will be those published by the clinical lab (Labcorp, INC).

 Any bleeding disorder

 Radiation exposure history will be collected. Subjects whose exposure history within the past twelve months would cause them to exceed their annual limits will be excluded.

 Pregnancy

['Gamma Tocopherol 700 mg capsules,', 'Placebo']

Gamma Tocopherol 700 mg capsules,
Placebo


EarlySense Monitoring Device Evaluation on CHF Patients

Summary: CHF patients will be monitored using EarlySense ES-16 device and will simultaneously fill diaries and log their weight daily. The data collected and analyzed by the ES-16 device will be correlated with the CHF status data.
Inclusion criteria: inclusion criteria:

 Age over 45 years old

 CHF class II or III with LVEF<40%

 Hospitalized at least once for CHF deterioration over previous 12 month period

 Able and willing to cooperate with this trial for at least a 3 month period

 Home close to participating center

Exclusion criteria: :

 Recent (within 3 month) admission to ICU or CC-ICU due to severe CHF episode requiring artificial ventilation

 Asthma or COPD


A Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions

Summary: The Dermacorder measures the electric field in the skin. Malignant skin lesions disrupt the skin's normal electric field and this abnormal electric field can be detected by the Dermacorder. Therefore the investigators are testing the hypothesis that the Dermacorder can provide useful data to guide in the diagnosis of skin disease.
Inclusion criteria: inclusion criteria:

 Study subjects must have had diagnosed at least one benign or malignant skin lesion;

 Subject is from 18-75 years of age, inclusive;

 Subject must sign and date all informed consent statements.

Exclusion criteria: :

 Subject is exhibiting signs of a bacterial or viral infection, including fever;

 Subject is unwilling to allow a biopsy of a malignant lesion for histological analysis.


Effect of a 10,000 EU Dose of Endotoxin in Allergic and Mildly Asthmatic Adults

Summary: The purposes of this pilot safety study are to identify a dose of inhaled Clinical Center Reference Endotoxin (CCRE) that is well tolerated by allergic subjects that induces measurable increases in neutrophil content of induced sputum that can be employed to screen large populations for susceptibility to the inflammatory effect of inhaled endotoxin.
Inclusion criteria: inclusion criteria:

 inclusion criteria

 Specific allergy to at least one of the following allergen preparations: (House Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1, Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive immediate skin test response.

 FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .75 (without use of bronchodilating medications for 12 hours), consistent with lung function of persons with no more than mild episodic or mild persistent asthma.

 History of nasal allergy, including episodic, perennial, or seasonal sneezing, nasal congestion or cough, or such symptoms associated with specific exposures (such as cat or dog)

 Criteria for classification as having asthma with allergic rhinitis vs. allergic rhinitis alone:

 History of episodic wheezing, chest tightness, or shortness of breath consistent with asthma, or physician diagnosed asthma.

 Provocative concentration of methacholine producing a 20% fall in FEV1 (PC20 methacholine) of less than 10 mg/ml by the method used (see below).

Exclusion criteria: :

 Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, or chronic thyroid disease.

 Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months.

 Use of systemic steroid therapy within the preceding 12 months for an asthma exacerbation. All use of systemic steroids in the last year will be reviewed by a study physician.

 Use of inhaled steroids, cromolyn or leukotriene inhibitors (Montelukast or zafirkulast) initiated within the past month (except for use of cromolyn exclusively prior to exercise). Patients must be on a stable regimen of therapy and shown to be stable.

 Use of daily theophylline within the past month.

 Pregnancy or nursing a baby.

 Cigarette smoking > 1 pack per month.

 Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma.

 Exacerbation of asthma more than 2x/week which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma.

 Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. (Not to include prophylactic use of albuterol prior to exercise).

 Dosing level of an inhaled steroid must be consistent with mild episodic asthma as outlined by the NHLBI NAEPP guidelines. Any dose of inhaled steroid typically used for moderate or severe asthma will result in exclusion from the protocol.

 Viral upper respiratory tract infection within 2 weeks of challenge.

 Any acute infection requiring antibiotics within 2 weeks of challenge.

['Clinical Center Reference Endotoxin (CCRE)']

['Rhinitis, Allergic, Perennial', 'Rhinitis, Allergic, Seasonal', 'Asthma']

Rhinitis Allergic Perennial Rhinitis Allergic Seasonal Asthma


The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders

Summary: To evaluate Efficacy and Safety of oral Atorvastatin and Dexamethasone on conservative treatment for Chronic Subdural Hematoma (CSDH) patients with Coagulation Disorders
Inclusion criteria: inclusion criteria:

 Age ≥18 and<90years old, both gender;

 Long-term antiplatelet and anticoagulant drugs cause Coagulation Disorders;

 CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult);

 The midline shift to less than 1 cm;

 Attending physician makes a judgment that cerebral hernia would not occur and surgical operation might not be performed in a short time. Conservative treatment is adopted;

 Patients have never undergo surgery on the hematoma;

 Patient fully understood the nature of the study, and voluntarily participates and signs informed consent.

Exclusion criteria: :

 Allergic to the statin and dexamethasone or its ingredients;

 Hematoma caused by tumors, blood and other known comorbidities;

 Abnormal liver function;

 Uncontrolled hepatitis and other liver diseases, as well as suffering from other disease may interfere the study;

 Patients have been on oral Statin treatment in the past four weeks;

 Patients have been on oral Steroids treatment for a long time;

 Diagnosed Diabetes patients with poorly controlled blood glucose

 Participate in clinical trials in the past four weeks;

 Pregnant or breastfeeding;

 Failure of completing the trial by poor compliance;

 For any reason, the researchers believe that the case is not suitable for inclusion.

['Atorvastatin', 'Atorvastatin and Dexamethasone']

Atorvastatin
Atorvastatin and Dexamethasone


The Head Injury-associated Photosensitivity and Pupillary Function (HIPP) Study

Summary: After a head injury, many people find that exposure to light causes them increased discomfort. By measuring how the pupil in the eye constricts to flashes of red and blue light, this study will investigate whether this phenomenon is due to a change in the eye's sensitivity to light.
Inclusion criteria: inclusion criteria:

 18+ years old

 reports a previous head injury that occurred at least 6 months ago

 score of 2 or 3 (mild TBI) on OSU-TBI ID Survey

 best-corrected visual acuity of at least 20/30 in both eyes

 reliable visual field

Exclusion criteria: :

 pregnancy

 significant afferent pupillary defect

 previous history of neurodegenerative disease

 intraocular pressure more than 21 mm Hg

 significant visual field defect

 active corneal pathology

 history of retinal or optic nerve disease

 strabismus (eye turn)

['Head Injury', 'Traumatic Brain Injury (TBI)', 'Photosensitivity', 'Photophobia']

Head Injury
Traumatic Brain Injury (TBI)
Photosensitivity
Photophobia


Measure of Cerebrospinal Fluid (CSF) Pressure Variation With Patient Positioning

Summary: This is a study looking at pressure changes in the fluid that surrounds the spine when a person is positioned in 2-3 different ways.
Inclusion criteria: inclusion criteria:

 Need a lumbar or cervical myelogram as part of routine care.

Exclusion criteria: :

 Not needing a myelogram in the cervical or lumbar spine.


Electrocautery vs Q-switch for Seborrheic Keratosis

Summary: The primary objective of this study is to compare the efficacy and risk of adverse events of electrocautery versus 532 nm Q-switched neodymium-doped yttrium aluminium garnet (Nd:YAG) laser for the treatment of flat seborrheic keratoses.~This study is a pilot study designed to determine feasibility of these procedures.
Inclusion criteria: inclusion criteria:

 Subjects are Caucasian or Asian.

 Subjects who are between 18-65 year olds.

 Subjects have flat or macular seborrheic keratosis on dorsum of the hands and wrists, extensor surfaces of the forearms. The diagnosis of flat seborrheic keratosis is confirmed by two clinical dermatologists using routine clinical examination and dermoscopy.

 Subjects have Fitzpatrick skin type I-III.

 Subjects are in good health.

 Subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator.

Exclusion criteria: :

 History of keloids or hypertrophic scars.

 Pregnant or lactating or intends to become pregnant in the next 3 months.

 Active skin disease or skin infection in the treatment area.

 Previous history of lidocaine allergy.

 History of methemoglobinemia

 Unable to understand the protocol or to give informed consent.

 Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical study or would pose as an unacceptable risk to subject.

['Hyfrecator', '532 nm Q-switched Nd:YAG laser']

Hyfrecator
532 nm Q-switched Nd:YAG laser


L-Thyroxine Supplementation for Preterm Newborns Less Than 32 Weeks of Gestation With Hypothyroxinemia

Summary: Transient hypothyroxinemia of prematurity (THOP) is associated with neurodevelopmental impairment in preterm newborns < 32 weeks of gestation (WG). It is not known whether L-Thyroxine supplementation for preterm newborns <32 WG with THOP is beneficial.~The purpose of this study is to compare L-thyroxine treatment vs. placebo in newborn less than 32 WG with THOP.~The primary endpoint is the neurodevelopmental outcome at two years of life, assessed by the Brunet-Lézine score. The secondary endpoints are: death, bronchopulmonary dysplasia (oxygen therapy at 28 days of life and at 36 weeks of postnatal age), patent ductus arteriosus, shock requiring fluid loading or vasoactive treatments, enterocolitis, intraventricular hemorrhage, retinopathy of prematurity, deafness.
Inclusion criteria: inclusion criteria:

 Gestational age < 32 WG

 FT4 (5, 6 or 7 days of life) ≤ 0.8 ng/dL

 TSH (5, 6 or 7 days of life) < 20 mIU/L

 Written consent from the parents

Exclusion criteria: :

 Maternal thyroid disease

 FT4 (5, 6 or 7 days of life) > 0.8 ng/dL

 TSH (5, 6 or 7 days of life) > 20 mIU/L

 Grade III or IV intracerebral hemorrhage


Study to Assess the Efficacy of Ipratropium Bromide Associated With High Dose Salbutamol by Repeated Nebulisation Versus Repeat Nebulisation of Salbutamol Alone, in Acute Asthmatic Attacks in Young Children

Summary: To determine whether addition of ipratropium bromide to salbutamol nebulisations produces significantly greater bronchodilation in young children presenting to an emergency department with an acute attack of asthma
Inclusion criteria: inclusion criteria:

 Boys or girls between 3 and 6 years old

 Presenting to emergency departments with an acute asthmatic attack

 Requiring nebulised bronchodilator therapy

 Rint increased by 200 % compared to theoretical Rint

 Signed, informed consent obtained from the child's parents/legal guardian in accordance with current national legislation and good clinical practice (GCP) defined by the International Conference on Harmonization (ICH)

Exclusion criteria: :

 Ipratropium bromide received within four hours before admission

 First acute asthmatic attack

 Hospital admission to intensive care with asthma within six months before inclusion

 Hospital admission for asthma during the month prior to inclusion

 Corticosteroid-dependent asthma (oral corticosteroid therapy) or recently stopped corticosteroid therapy

 Concomitant cardiac disease

 Life threatening disease requiring immediate management; including: silent chest on auscultation, cyanosis, bradycardia less than 60 beats/min (bpm), confusion, coma

 Hypersensitivity to ipratropium bromide, salbutamol, or to any of their excipients

 Renal or hepatic insufficiency

 Poorly controlled diabetes

 Patients suffering from a disease considered to be severe by the investigator and which, in the opinion of the investigator, could interfere or invalidate the measurements performed in the trial

 Past history of lung surgery

 Major respiratory disease: pulmonary fibrosis, bronchiectasis, sarcoidosis, tuberculosis, respiratory disease due to AIDS, cystic fibrosis

 Patients unable to follow with protocol or correctly undergo the evaluations

 Patients who are taking part in another clinical trial during this trial or who have done so within the month before the trial

 Previous participation in this trial

['Ipratropium bromide', 'Placebo', 'Salbutamol']


Corticosteroids and Hemoglobin A1C Levels in Diabetic Patients With COPD Exacerbation

Summary: Corticosteroid treatment in diabetic patients admitted for COPD exacerbation are expected to significantly increase hemoglobin A1C levels
Inclusion criteria: inclusion criteria:

 Diabetic patients with COPD exacerbation

Exclusion criteria: :

 Patients treated with steroids during the previous 3 months

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

Diabetes
Chronic Obstructive Pulmonary Disease


A Two Part Trial Investigating NN1952 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes

Summary: This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerance, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NN1952 as tablets in healthy volunteers and subjects with type 1 and type 2 diabetes.~The trial consists of two parts. In part 1, single escalating doses of NN1952, placebo or insulin aspart will be given to healthy volunteers. In part 2, subjects with type 1 or type 2 diabetes will receive single doses of NN1952 (with/without a meal), insulin aspart and placebo.
Inclusion criteria: inclusion criteria:

 FOR TRIAL PART 1, THE FOLLOWING APPLIES:

 Gender: male

 Age: 18-55 years

 BMI (body mass index): 18-28 kg/m2

 Study participants considered to be healthy

 FOR TRIAL PART 2, THE FOLLOWING APPLIES:

 Gender: male or female of no childbearing potential

 Age: 18-65 years

 Type 1 diabetes: BMI (body mass index): 18-28 kg/m2

 Type 2 diabetes: BMI (body mass index): 22-35 kg/m2

 Type 1 or type 2 diabetes for at least 12 months

 Type 1 diabetes: Treatment with insulin for at least 12 months

 Type 2 diabetes: Treatment with insulin for at least 3 months

Exclusion criteria: :

 Known or suspected allergy to the trial product or related products

 Presence of illness or infection that may confound the results of the study or pose a risk to the study participant by dosing NN1952, as judged by the Investigator

 Presence of acute gastrointestinal symptoms (for example nausea, vomiting, heartburn or diarrhoea)

['NN1952', 'insulin aspart', 'placebo', 'NN1952', 'insulin aspart', 'placebo']

NN1952
insulin aspart
placebo
NN1952
insulin aspart
placebo

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

Diabetes
Diabetes Mellitus
Type 1
Diabetes Mellitus
Type 2
Healthy


Overeating Different Fats and Influence on Muscle Mass and Body Fat Accumulation

Summary: To investigate metabolic and molecular response to fatty acid-specific overfeeding in overweight subjects, in relation to changes in ectopic fat, lean tissue mass and insulin sensitivity
Inclusion criteria: inclusion criteria:

 Body mass index 25-32

Exclusion criteria: :

 Type 2 diabetes

 Type 1 diabetes

 Kidney disease

 Liver disease

 Abnormal clinical chemistry at screening

 Intense physical exercise > 2 hours per week

 Use of statins or drugs affecting energy metabolism

 Use of extreme diets

['Obesity', 'Overfeeding', 'Muscle Mass', 'Body Composition', 'Ectopic Fat']

Obesity
Overfeeding
Muscle Mass
Body Composition
Ectopic Fat


Is the Routine Pressure Dressing After Thyroidectomy Necessary?

Summary: Thyroidectomy is an operation that is commonly performed. After an operation a pressure dressing by Hypafix is usually used due to the belief that it will help to reduce complications such as post-operative bleeding or haematoma. However, the practice is uncomfortable to patients and makes it hard to detect early haematomas.~We carried out a prospective randomised study to study the role of pressure dressing after thyroid surgery by evaluating the amount of fluids collected in the operative bed by ultrasonography compared with normal dressing.
Inclusion criteria: inclusion criteria:

 Patients underwent thyroidectomy in Srinagarind hospital, Khonkaen University

Exclusion criteria: :

 Patients with cervical lymph nodes metastases requiring neck dissection

 Patients that tissue pathology shown anaplastic carcinoma

 Patients with clinical or laboratory indicators of coagulation disorders

['Normal dressing', 'Pressure dressing']

['Thyroid Neoplasms', 'Thyroid Nodules', 'Graves Disease', 'Goiter']

Thyroid Neoplasms
Thyroid Nodules
Graves Disease
Goiter


Compliance With Dietary Recommendations in Children at Risk for Undernutrition

Summary: This study will assess compliance with dietary recommendations, in conjunction with a nutritional supplement to meet the nutritional requirements in children and the effects of the compliance on promoting growth in children who are at risk of under-nutrition.
Inclusion criteria: inclusion criteria:

 Child is between 36 and 48 months of age.

 Child has weight-for-height greater than or equal to 5th and less than or equal to the 25th percentile.

 Child is capable of oral feeding.

 Child's parent(s)or Legal Guardian is willing to abstain from giving additional non-study nutritional supplements to the child throughout the study period.

Exclusion criteria: :

 Child whose either parent has BMI greater than or equal to 27.5 kg/m2.

 Child allergic or intolerant to any ingredient found in the study product.

 Child who was delivered pre-term.

 Child was born small for gestational

 Child had birth weight < 2500 g or > 4000 g.

 Child has current acute or chronic infections.

 Child demonstrates presence of severe gastrointestinal disorders.

 Child has a diagnosis of neoplastic diseases, renal, hepatic and cardiovascular diseases.

 Child has a diagnosis of hormonal or metabolic disorders.

 Child has a congenital disease or genetic disorder.

 Child is diagnosed with infantile anorexia nervosa.

 Child has a developmental disability or physical disorder.

 Child has disorders of hemoglobin structure, function or synthesis.

 Child is participating in another study that has not been approved as a concomitant study.


Role of Altered CD40-Ligand Gene Transcription in Systemic Lupus Erythematosus

Summary: Systemic lupus erythematosus is an often devastating autoimmune disease which affects 1 in 2,000 women in the United States. Recently, several research laboratories have reported that a protein, named CD40-ligand (CD154), is overexpressed by a subset of white blood cells, called lymphocytes, in patients with lupus. Expression of CD154 appears critical to the generation of antibodies that cause disease in lupus. Blocking CD154 interactions in the immune system has been shown to decrease disease activity in animal models of lupus. We propose to study the regulation of CD154 in patients with lupus in hopes of inhibiting its abnormal and deleterious expression.
Inclusion criteria: Inclusion:

 A diagnosis of systemic lupus erythematosus
Exclusion criteria:


Penicillin and Metronidazole in Treatment of Peritonsillar Abscess

Summary: Treatment of peritonsillar abscess varies. To study whether broad spectrum antibiotics are required in addition to abscess drainage, a prospective, double blind, placebo-controlled, randomized study on 200 adult patients with peritonsillar abscess is performed. 100 patients are given penicillin and metronidazole and 100 patients get penicillin and placebo. Recovery and recurrence are analyzed.
Inclusion criteria: inclusion criteria:

 referring doctor suspects peritonsillar abscess

 patient is voluntary

 patient has daily access to his/her e-mail

 patient speaks and understands Finnish of Swedish

 female patients have adequate birth-control method

 patient has peritonsillar abscess

Exclusion criteria: :

 allergy to penicillin

 allergy to metronidazole

 use of metronidazole in preceding one month

 pregnancy

 breast-feeding

 renal insufficiency

 liver insufficiency

 alcoholism (drunk at least once a week)

 participant in another clinical trial at the moment

 treatment of peritonsillar abscess requires in-patient care

 tonsillectomy during the next 30 days

 army recruit

['penicillin and metronidazole in peritonsillar abscess']


Investigating Reaction Time Among Children Who Snore

Summary: The investigators feel that children who have OSA or sleep-disordered breathing may have a different reaction time than normal variants. Children who have OSA are known to have behavioral and sleep patterns that are different. It makes sense their reaction time may be different than normal as well. We plan to measure reaction times via a 10 minute psychomotor vigilance test device in children who snore who are coming in for a sleep study or for adenotonsillectomy.
Inclusion criteria: inclusion criteria:

 Ability to understand how to perform reaction time test and complete without assistance.

Exclusion criteria: :

 Children who are unable to understand or perform test or parents refusal.


Placebo-Controlled Onset-of-Action Study of Flurbiprofen Utilizing the Double-Stopwatch Method

Summary: The study's purpose is to demonstrate the onset of action, i.e., time to meaningful pain relief in patients with pharyngitis, of flurbiprofen 8.75 mg lozenge using the Double-Stopwatch Method (DSW).
Inclusion criteria: inclusion criteria:

 Primary diagnosis: pharyngitis confirmed by a Tonsillo-Pharyngitis Assessment ≥ 5

 Complaint of sore throat with an onset ≤ 4 days prior to randomization

 Have at least one symptom of upper respiratory tract infection (URTI) on the URTI Questionnaire (e.g., sore throat, runny nose, cough, fever)

 Have moderate or severe sore throat pain on the Throat Pain Scale

 Have a baseline Sore Throat Scale (STS) ≥ 6

 If the patient is a female of childbearing potential, she has been using effective contraception since the last date of menses and is not breast-feeding or lactating. She is also willing to take adequate contraceptive precautions through 24 hours after the completion of the study.

 If the patient is a female of childbearing potential, the patient must have a negative urine pregnancy test (UPT) result (indicating not pregnant) obtained on the day of scheduled randomization, prior to the designated time of randomization

 The patient is willing to remain at the study centre for 3 hours after receiving the dose of study medication

 During the 3-hour evaluation of the study medication lozenge at the site, the patient is willing to take nothing by mouth (e.g., no smoking, food, candy, lozenges, chewing gum, liquids).

Exclusion criteria: :

 Known allergy and/or hypersensitivity to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), or any other inactive ingredients such as honey, lemon flavor, menthol, or sucrose.

 History of an upper gastrointestinal ulcer within the past 60 days, current clinically significant upper gastrointestinal complaints, or current regular use (≥ 3 times in the previous week) of any medication for upper gastrointestinal symptoms, including antacids, H2 blockers, proton pump inhibitors or sucralfate

 History of any hepatic disease or renal dysfunction

 Other severe acute or chronic medical condition that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.

 History of chronic analgesic use (≥ 3 times per week over the prior 4 weeks)

 Use of an antibiotic for an acute disease within the previous 24 hours before randomization. (Chronic antibiotic use, such as for acne, is acceptable.) Use of any quinolone antibiotic such as ciprofloxacin or nalidixic acid within the past week or concurrently is specifically prohibited.

 Use of mifepristone in the 12 days prior to the screening visit

 Use of inhaled therapy (e.g., inhaled steroids or β-agonists, such as Ventolin) on an acute basis for disease exacerbation in the week prior to the screening visit

 Use of any immediate release analgesic within 4 hours preceding administration of the study medication.

 Use of any sustained release analgesic within 12 hours preceding administration of the study medication.

 Use of any cold medication (i.e. decongestants, antihistamines, expectorants, antitussives) within 4 hours preceding administration of the dose of study medication.

 Use of any throat lozenge, throat spray, cough drop, or menthol-containing product within 2 hours preceding administration of the study medication

 Consumption of any caffeine-containing beverage (e.g., coffee, tea, hot chocolate, caffeinated soft drinks) within 5 minutes preceding administration of the study medication.

 Any evidence of mouth-breathing (which could worsen sore throat pain).

 Coughing that causes throat discomfort or any active physical disease (such as bronchopneumonia) which could compromise respiratory function and worsen a sore throat

 Unable in the opinion of the Investigator to comply fully with the study requirements


Defining Normal Citrulline Levels as a Diagnostic Tool for Screening of Gastrointestinal Disease in Premature Infants

Summary: Since the first description of citrulline as a potential marker for intestinal function in 1998, its use has been investigated in a variety of disease processes including Short Bowel Syndrome, Celiac disease, chemotherapy and radiation induced intestinal injury, infections producing intestinal cytopathic effects like Adenovirus, and predicting rejection in intestinal transplantation. The use of citrulline levels as a diagnostic tool to predict gastrointestinal disease in the premature population has not been properly addressed.~The introduction of enteral nutrition in the premature infant is a process of trial and error, knowing that the immaturity of the gastrointestinal system may lead to frequent episodes of feeding intolerance. This is augmented by the fear of the development of necrotizing enterocolitis (NEC) once feeds are commenced. NEC is a condition characterized by disruption of the intestinal epithelial barrier, a pathogenic process shared with some of the conditions mentioned above for which citrulline has proven clinically useful.~A normal pattern of citrulline production has not been established in the premature population. Previous studies have shown decreased levels of glutamine and arginine in premature infants up to 10 days prior to the development of necrotizing enterocolitis. Glutamine and arginine are two amino acids closely involved in the synthesis and catabolism of citrulline.~The investigators therefore hypothesize that defining a normal pattern of citrulline production in the premature population may prove to be a clinically useful diagnostic tool to screen for gastrointestinal disease.
Inclusion criteria: inclusion criteria:

 1. Premature infants with gestational age between <32 weeks regardless of birth weight

Exclusion criteria: :

 Inborn errors of metabolism

 Need for exchange transfusion

 Multiple congenital anomalies

 Renal failure (defined as urine output <1ml/k/h >24h, creatinine >1.8, or diagnosis of non-oliguric renal failure as determined by Pediatric nephrology)

['Premature Newborn', 'Necrotizing Enterocolitis']

Premature Newborn
Necrotizing Enterocolitis


Safety Skills Training: Parents of School-Aged Children

Summary: Injuries are the leading cause of death and disability in children in America. Most injuries can be prevented when parents implement effective child safety practices. This project will create a behaviorally based program to teach parents what to do to prevent injuries to their school aged child, in an effort to reduce the number of injuries, hospitalizations, medical costs, and missed work days.
Inclusion criteria: inclusion criteria:

 The basic lower age limit for parents or guardians of children aged 6-11 for this study was 18. Parents or legal guardians could potentially be as old as 65 or older.

Exclusion criteria: :

 Only English-speaking participants were accepted because the program was developed only for English speakers. All English-speaking parents or guardians living in the U.S., with children aged 6-11 years old, who wished to participate were included. Parents under 18 were excluded from this online study because parental consent cannot be obtained online.

['Am Academy of Pediatrics print materials', 'Family safety 1-2-3']


An Investigation Into Bone Micro-architecture in Women With Type 2 Diabetes

Summary: The number of people with type 2 diabetes is growing. This puts a lot of pressure on the health care systems. Type 2 diabetes is often associated with health problems, like poor eyesight, muscle coordination, muscle strength, and blood flow. Poor bone health may also be a concern for people with type 2 diabetes.~A large proportion of people with type 2 diabetes will break a bone in their lifetime. The risk of this happening in older people with type 2 diabetes is greater than the risk in older people without diabetes. Fracturing a bone can be very painful, and lead to serious consequences, especially if the individual experiences a hip fracture. The elevated fracture risk, seen in those with type 2 diabetes, is puzzling because people with type 2 diabetes often appear to have normal, healthy bones compared to people of the same age without diabetes.~Bone micro-structure, which is not assessed by traditional bone densitometry systems (ie: DXA) contributes to overall bone strength.~The hypothesis of this study is that bone micro-structure is of poorer quality (reduced trabecular thickness, increased trabecular spacing) in postmenopausal women with type 2 diabetes, compared to age-matched control participants.
Inclusion criteria: inclusion criteria:

 female

 >= 65 years old

 postmenopausal for > 5 years (WHO definition of menopause)

Exclusion criteria: :

 currently taking osteoporosis related medication (HRT, SERM, bisphosphonate, PTH, calcitonin, fluoride)

 had cancer in past 10 years, likely to metastasize to bone (ie: breast, lung)

 have intrinsic bone disease (ie: Paget's Disease, Cushings syndrome)

 have untreated malabsorption syndrome (ie: Celiac Disease)

 renal insufficiency (CrCl <30ml/min)

 hyperparathyroidism, hypoparathyroidism

 chronic systemic glucocorticosteroid use > 3mos, dose>2.5mg daily


Vibration Response Imaging in the Diagnosis of Pulmonary Disease

Summary: Vibration Response Imaging (VRI) is novel technology which records breath sounds via pizo-electric sensors and produces a digital image using a computer algorithm. It is radiation free and is portable to the patient's bedside. Data exists to show that the recordings from normal individuals differs from those who have pulmonary pathology. There is also evidence that recordings have high levels of inter and intra-observer reliability. However, data on specific VRI patterns for specific pathology is still needed before this can be used as a diagnostic tool. We aim to perform an open label feasibility trial on inpatient and outpatient pulmonary patients. Bedside clinical examination and chest auscultation will be used as the reference gold standard. Other diagnostic modalities that have been used as part of the patient's usual standard of care will also be used for comparison. Specifically breath sound progression, the maximal sound energy shape/distribution and the presence of artifactual sounds will be used to search for patterns that may be used for diagnosis. Sensitivity and specificity will be calculated for each disease (eg. asthma, emphysema, bronchiectasis, pneumonia, effusion, pneumothorax, etc)
Inclusion criteria: inclusion criteria:

 All adult ( ≥ 21 years old ) patients (inpatients and outpatients) under the care of the Department of Respiratory and Critical Care Medicine between 1/07/2008 and 31/05/2009 will be considered eligible.

 Children may have too small body sizes for the current standard sensors and will not be recruited.

 Other inclusion criteria will be ability to provide informed consent.

Exclusion criteria: :

 Conditions that will prevent the placement of sensors oh the patients back such as bony/chest wall deformity and contagious skin conditions.

 The presence of a pacemakers and pregnancy are also considered contraindications because of the yet undefined safety issues associated with these conditions.

['Respiratory Diseases', 'Pulmonary Diseases', 'Thoracic Diseases', 'Lung Diseases']

Respiratory Diseases
Pulmonary Diseases
Thoracic Diseases
Lung Diseases


Study of Triostat in Infants During Heart Surgery

Summary: This is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine (Triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease during cardiopulmonary bypass surgery.
Inclusion criteria: inclusion criteria:

 Diagnosis of one of the following:

 Ventricular septal defect (VSD)

 Infant coarctation of the aorta

 Transposition of the great arteries

 Tetralogy of Fallot

 Complete atrioventricular canal defect

 Hypoplastic left heart, including patients who undergo a Norwood type procedure for aortic or mitral atresia

 Patient must be scheduled for surgery.

Exclusion criteria: :

 Certain additional defects and/or requirement for additional surgery.

['Liothyronine sodium/triiodothyronine', 'Cardiopulmonary bypass and cardiac surgery']


Aripiprazole in Children and Adolescents With Bipolar Disorder and Attention Deficit Hyperactivity Disorder (ADHD)

Summary: There is a scarcity of clinical trials assessing the effects of medications in children with bipolar disorder. This study aims to assess the efficacy of Aripiprazole (a novel anti-psychotic drug) for the treatment of children and adolescents with bipolar disorder comorbid with ADHD. The study design is a 8-week randomized, double blind, parallel group trial. Patients were randomized to either aripiprazole or placebo.~The main hypotheses are:~Aripiprazole will significantly reduce maniac scores compared to placebo~Aripiprazole will significantly reduce ADHD scores compared to placebo
Inclusion criteria: inclusion criteria:

 Age: 8-17

 BD type I or II comorbid with ADHD

 Baseline score in the YMRS > or = 20

Exclusion criteria: :

 IQ < 70

 Pharmacologic treatment in the last month

 Pregnancy or absence of a contraceptive method in fertile girls

 Diagnoses: pervasive development disorder, schizophrenia, drug abuse or dependency

 Risk of suicide or homicide

 Clinical condition that might interfere in the study

 Known sensibility to aripiprazole

['Bipolar Disorder', 'Attention Deficit Hyperactivity Disorder']


Hair-sparing Whole Brain Radiotherapy

Summary: Up to 10% of patients with cancer will develop symptomatic brain metastases. Given this limited survival it is important to consider quality of life (QOL) when treating these patients. Whole brain radiotherapy (WBRT) can increase survival to 6 month. However, WBRT itself has been shown to reduce QOL by increasing drowsiness, leg weakness and hair loss in patients with brain metastases. Both fatigue and hair loss were reported to have the largest decline in QOL scores when WBRT is used in the prophylactic setting in small cell lung cancer. Recent technological improvements in patient positioning and treatment planning will allow us to treat the whole brain with reduced margins, allowing better sparing of the scalp. In view of the large impact of hair loss on quality of life, the investigators hypothesize to see an improved quality of life with scalp sparing techniques.~Study hypothesis: Volumetric arc therapy results in a reduced hair loss and a subsequent clinically important improvement in QOL.
Inclusion criteria: inclusion criteria:

 Brain metastases

 Age ≥ 18 years.

 Signed informed consent

 Recursive Partitioning Analysis (RPA) class III patients

 Recursive Partitioning Analysis (RPA) class I-II patients and >3 brain metastases

 Patients with small cell lung cancer extended disease eligible for prophylactic Whole-Brain Radiotherapy (WBRT).

Exclusion criteria: :

 Previous whole brain radiotherapy

['Whole brain radiotherapy with volumetric arc therapy']

['Brain Metastases', 'Small Cell Lung Cancer']


Type Distribution of Human Papillomavirus in Adult African Women Diagnosed With Invasive Cervical Cancer

Summary: The aim of the study is to assess the distribution of the most frequent types of human papillomavirus in African women diagnosed with invasive cervical cancer.
Inclusion criteria: inclusion criteria:

 A female aged 21 years or more, presenting with a lesion macroscopically suggestive of invasive cervical cancer.

 Scheduled for cervical biopsy as per routine procedure at the participating institution on the day of the visit or on a later date.

 Written or oral-witnessed informed consent obtained from the subject prior to any study procedure.

 No prior chemo- or radiotherapy for cervical cancer.

Exclusion criteria: :

 Not applicable

['Collection of cervical cancer tissue samples', 'Data collection']

['Infections, Papillomavirus', 'Cervical Cancer']

Infections
Papillomavirus
Cervical Cancer


A Chinese Randomized Crossover Study of Erlotinib Versus Docetaxel/Cisplatin in Previously Untreated Stage IIIB/IV Lung Adenocarcinoma With EGFR Mutations

Summary: Objective: the objective of this study in china is to clarify, whether the overall survival is different between previously untreated stage IIIB/IV lung adenocarcinoma with EGFR mutations receiving first-line erlotinib plus second-line docetaxel/cisplatin and those receiving first-line docetaxel/cisplatin plus second-line erlotinib .
Inclusion criteria: inclusion criteria:

 Male and female patients aged over 18 years

 Histologically proven lung adenocarcinoma

 clinical stage IIIB/IV

 ECOG performance status 0-2

 Had no prior anticancer agent, radiation or surgical therapy for lung adenocarcinoma

 At least one measurable lesion (according to RECIST)

 Provision of written informed consent

 Life expectancy of at least 12 weeks

Exclusion criteria: :

 History of malignant disease.

 Evidence of clinically active interstitial lung diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)

 Expected life expectancy less than 2 months

 As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)

 Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x ULN if no demonstrable liver metastases (or >5 x in presence of liver metastases)

 Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study

 Pregnancy or breast-feeding women (women of child¬bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.

['Erlotinib', 'Docetaxel', 'Cisplatin', 'Docetaxel', 'Cisplatin', 'Erlotinib']

Erlotinib Docetaxel Cisplatin Docetaxel Cisplatin Erlotinib

['Neoplasms, Lung', 'Carcinoma, Non-Small Cell Lung', 'Drug Therapy', 'Genes, EGFR']

Neoplasms
Lung
Carcinoma
Non-Small Cell Lung
Drug Therapy
Genes
EGFR