Effects of Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea (OSA)

Summary: The aim of the present study is to compare the effects of different types of antihypertensive drugs (angiotensin II receptor blockers and long-acting calcium channel blockers) in patients with hypertension and obstructive sleep apnea who are not controlled well with their hypertension after continuous positive airway pressure therapy.
Inclusion criteria: inclusion criteria:

 Apnea and hypopnea index of more than 20 /hr, and treated with CPAP

 Uncontrolled hypertension (defined as systolic blood pressure of more than 130 mmHg or diastolic blood pressure of more than 80 mmHg

Exclusion criteria: :

 Cerebrovascular diseases, myocardial infarction, angina pectoris or heart failure within 6 months

 Uncontrolled arrhythmia

 Severe hepatic or renal disorders

 Having poor prognosis disorders such as malignant disorders

['Obstructive Sleep Apnea', 'Hypertension']


A Study of Rofecoxib in Familial Adenomatous Polyposis (FAP) (0966-205)(TERMINATED)

Summary: A study to evaluate rofecoxib in the treatment of rectal, colon, or duodenal adenomas in patients with Familial Adenomatous Polyposis.
Inclusion criteria: inclusion criteria:

 Males or females at least 18 years of age with familial adenomatous polyposis.
Exclusion criteria:

['MK0966; rofecoxib / Duration of Treatment: 24 weeks', 'Comparator: placebo / Duration of Treatment: 24 weeks']


BRIPPED Scan for Evaluation of Emergency Department (ED) Patients With Shortness of Breath

Summary: The B-RIPPED scan is a standardized ultrasound evaluation of pulmonary B-lines, Right ventricle size and strain, Inferior Vena Cava collapsibility, Pleural and Pericardial Effusion, Pneumothorax, Ejection Fraction, and lower extremity Deep Venous Thrombosis. Primary outcomes measured are the magnitude of change in differential diagnoses.
Inclusion criteria: inclusion criteria:

 Subjects are included if they are between the ages of 18-89 and present to the Emergency Department with a chief complaint of shortness of breath or dyspnea.

Exclusion criteria: :

 known history of asthma,

 are 20 or more weeks pregnant, or

 have had thoraco-abdominal trauma in the past 72 hours.


Sleep and Endometrial Cancer

Summary: This study proposes to test the hypothesis that zolpidem taken the night before major surgery for endometrial cancer will improve sleep efficiency and reduce post surgery pain, as well as reduce the need for analgesic medication.
Inclusion criteria: inclusion criteria:

 be women at least 18 years old

 have clinical indications of primary endometrioid adenocarcinoma of the endometrium

 be scheduled for staging surgery by laparotomy under standardized protocols

 have the ability to communicate in English sufficient for completion of study materials

 have no neuromuscular/ movement disorders (for actigraphy purposes)

 have no uncontrolled medical, sleep, endocrine or psychiatric illness (as determined by their attending physician as part of clinical care)

 have no ongoing use of medication known to affect sleep or wake function (e.g., hypnotics, benzodiazepines, antidepressants, anxiolytics, antipsychotics, decongestants, sedating antihistamines, beta blockers, corticosteroids)

Exclusion criteria: :

 have a history of previous or concomitant cancer

 have an estimated life expectancy of < 6 months

 will be admitted to the hospital prior to the day of surgery

 are unable to complete study measures

 are unable to provide meaningful informed consent

['Sleep', 'Endometrial Neoplasms', 'Pain']


Management of Recurrent Croup

Summary: Presently children who experience recurring croup symptoms receive a variety of treatments. This is because it is not clear which treatments may be best. Some children are given inhaled steroids (similar to what children with asthma use). Others are carefully watched and cautioned to avoid potential triggers (certain foods, environmental allergens, etc), and should episodes of croup recur they are treated with a short course of oral steroids. The purpose of this study is to compare two safe and clinically appropriate methods for treating recurrent croup, daily inhaled steroids versus observation with oral steroids on an as needed basis, to see if either is useful in preventing future episodes of croup.
Inclusion criteria: inclusion criteria:

 Pediatric population: 6 months to 15 years of age

 2 or more episodes of croup in 12 month period

 croup defined as acute onset inspiratory stridor, barking cough, with respiratory distress.

Exclusion criteria: :

 Grade 3 or 4 subglottic stenosis

 Subglottic hemangioma

 Posterior laryngeal cleft

 Recurrent respiratory papillomatosis

 External compression (Innominate artery compression, mediastinal mass, (double aortic arch, etc)

 Symptoms or signs suggesting another cause of stridor, such as epiglottitis, bacterial tracheitis, or supraglottic foreign body

 Tracheomalacia/ bronchomalacia severe enough to cause respiratory distress

 Current steroid therapy for previously diagnosed condition, i.e. reactive airway disease.

 Other medical conditions necessitating chronic steroid utilization

['Fluticasone', 'Prednisolone IF needed']


Left Atrial Distensibility Guiding Management in Advanced Chronic Heart Failure

Summary: Background and Purpose- According to our prior studies, left atrial (LA) distensibility was associated significantly with left ventricular filling pressure in patients with acute myocardial infarction (AMI), chronic stable angina, and severe mitral regurgitation. LA distensibility can be used as noninvasive Swan-Ganz catheter. Additionally, it could predict in-hospital mortality in AMI patients. In the current study, left atrial distensibility guiding management in advanced chronic heart failure will be performed to assess whether those management could influence long-term prognosis including mortality rate, rehospitalization rate and the duration of rehospitalization.~Materials and Methods- Advanced chronic heart failure (HF) is defined as left ventricular ejection fraction less than 35%, creatinine less than 2 mg/dL, and CHF NY functional class III-IV for more than 3 months. Enrolled patients should be admitted to hospital due to heart failure requiring adjustment of inotropic agents or diuretics within recent 6 months. Three hundred HF cases will be recruited - 100 with sinus rhythm, and 100 with atrial fibrillation served as LA distensibility guided treatment group (guide group) and another 100 patients, either sinus rhythm or atrial fibrillation, served as control group. The management of guide group will be adjusted by LA distensibility, including the dose of inotropic agents, diuretics, beta-blocker, ACEI, and AIIB. Initially, the guide group will be followed 1 time per 2 week at first 3 months, then 1 time per month later. The control group will be treated by conventional management and traditional echocardiography can be performed as in-charge doctor request. The necessity of hospitalization for heart failure will be adjusted by 2 cardiovascular specialists and all patients admitted for heart failure will be managed by the same one cardiovascular specialist (Shih-Hung Hsiao). The total duration of follow-up will be 2 years. For life-threatening heart failure, intravenous nitroprusside drip under continuous A-line monitor, percutaneous coronary intervention, Swan-Ganz catheter insertion, intra-aortic balloon pump, and ECMO can be done according to the order of in-charge doctor. The primary end-point will be all-cause mortality. The second end-points will be heart failure with hospitalization and the duration of each hospitalization. Additionally, the ratios of medication changes in 2-year follow-up, including diuretics, inotropic agents, beta blockers, ACEI, and AIIB, will be assessed. Analysis will also be performed to estimate the trends of heart function (either systolic or diastolic) and renal function during 2-year follow-up according to whether guiding by LA distensibility is done or not.
Inclusion criteria: inclusion criteria:

 Advanced chronic heart failure (HF) will be defined as left ventricular ejection fraction less than 35%, creatinine less than 2 mg/dL, and CHF NY functional class III-IV for more than 3 months. Enrolled patients should be admitted to hospital due to heart failure requiring adjustment of inotropic agents or diuretics within recent 6 months.

Exclusion criteria: :

 presence of mitral stenosis or prosthetic mitral valve

 any abnormality of atrial septum (e.g., atrial septal defect or aneurysm)

 inadequate image quality

 lack of informed consent

['left atrial distensibility-guiding prescription of heart failure drugs']


A Trial of Tap Water Treatment in the Elderly

Summary: This study is being conducted in Sonoma County, California.~Gastrointestinal illness and diarrhea are recognized as a significant cause of morbidity and mortality in the elderly. One study showed that 51% of deaths caused by diarrhea over a 9-year period occurred in individuals over the age of 74 years. Although many infectious diseases are more problematic in the elderly because of a decline in immune function and a higher incidence of pre-existing malnutrition and dehydration, it is still not known what the principal modes of transmission are and which infectious agents are responsible.~The principal objective of this study is to evaluate the ability of in-home treatment of tapwater to reduce gastrointestinal illness in non-institutionalized elderly individuals. The trial will test household-level treatment of drinking water by joint use of ultraviolet light and filtration devices. A secondary objective is an estimate of the incidence of specific bacterial, viral, and protozoan agents in stool specimens collected from elderly individuals with gastrointestinal symptoms that might be related to water consumption.
Inclusion criteria: inclusion criteria

 55 years or older

 primary source of drinking water used at home is supplied by Sonoma County Water Agency without use of home filtration device or bottled water

 all individuals living in the home must sign informed consent and agree to have the water treatment device installed

 no known immunocompromising conditions (including HIV/AIDS, active cancer, or transplant recipients).

Exclusion criteria: :

 persons with immunocompromising condition (including HIV/AIDS, active cancer, or transplant recipients)

 employees and family members of the Sonoma County Water Agency or a Sonoma County Water District

['home drinking water treatment device']


A Pilot Trial of Ranolazine to Treat Patients With Dilated Cardiomyopathy

Summary: Recent data suggest that areas of fibrosis and hibernating myocardium develop in patients with non ischemic dilated cardiomyopathy. Ranolazine is a new drug, developed to releave symptoms of angina in patients with stable coronary disease that is not suitable for surgical or percutaneous revascularization. It has been shown that in patients with stable coronary disease Ranolazine improves myocardial perfusion as shown with myocardial nuclear imaging. The aim of this trial is to evaluate effects of ranolazine on myocardial perfusion in patients with dilated cardiomyopathy.
Inclusion criteria: inclusion criteria:

 established diagnosis of non-ischemic dilated cardiomyopathy

 EF < 35%

 NYHA f.c. II - IV

 Optimal medical management > 6 months

 Age < 75 years and > 18 years

Exclusion criteria: :

 known hypersensitivity to the medication

 age > 75 years or < 18 years

 EF > 35%

 renal insufficiency (GF < 30)

 liver dysfunction (liver tests > 3x the upper normal limit))

 LQT syndrome

 drugs that affect CYP3A4 metabolism (azoles, macrolides, calcineurin inhibitors etc.)

 dementia

 active hemathological or malignant disease


Genetic Evaluation of AAAS Gene in Early-Onset Achalasia and Alacrima Patients

Summary: The AAAS gene has been known to cause achalasia, alacrima, adrenal abnormalities and a progressive neurological syndrome. A considerable proportion of achalasia patients have been known to show alacrima (decreased secretion of tears). However, the genetic mechanism between achalasia and alacrima has not been defined yet. The investigators postulated that some proportions of early-onset achalasia could be correlated with AAAS gene; thus, the investigators aimed to investigate the relationship between the AAAS gene and early-onset achalasia.
Inclusion criteria: inclusion criteria:

 early age onset

 primary achalasia patient

 less than 35 years old

Exclusion criteria: :

 secondary achalasia patients


Hair Cortisol Level as a Predictor of PTSD Development

Summary: Post-traumatic stress disorder, PTSD, is one of the most prevalent psychiatric disorders.~As casualties of motor vehicle accidents, criminal acts or terrorism are arriving to the ER, it is almost impossible to conclude who will overcome his psychiatric trauma and will be able to return to his normal life course and who will be thrown out of his promising life trajectory.~Current attempts to identify those who are at the greatest risk are still unsatisfactory, which comprise a therapeutic dilemma, since the interventions used to ameliorate and prevent the occurrence of PTSD in a high-risk patient, might be counter-productive and even precipitate the emergence of PTSD in lower-risk patients.~Since PTSD is closely related to the Fight, Flight or Freeze reaction, it has much to do with the autonomic nervous system and the major stress hormone, cortisol. Despite many studies demonstrating the involvement of those factors in the development of PTSD, various attempts to profile the direction of the association between PTSD and cortisol abnormalities have yielded conflicting results.~The introduction of a novel method of assessing the excretion of cortisol using residues in the human hair shaft, has allowed an unprecedented evaluation of its activity over a prolonged period of time.~Using this novel method of cortisol assessment, the investigators aim to identify biomarkers that will be able to aid in the prediction of PTSD development ahead of symptoms emergence, and will enhance the understanding of the physiological mechanism involved and etiology of this disorder.
Inclusion criteria: inclusion criteria:

 Age 18-50

 Experienced a traumatic event fitting criterion A1 (stressor), A2 (Reaction) and at least 1 out of the B criterion in the ASD criteria in the DSM-IV-TR

 Brought to the ER within hours of the traumatic event.

 Signed an informed consent

Exclusion criteria: :

 Known psychiatric disorder or current psychiatric medication

 Complex injury or need for a complex medical treatment, such as operation, Packed RBC or admission extending 36 hours.

 Disorientation, confusion, head injury including intra-cranial bleeding, LOC or a major neurological deficit.

 Known disorder of the HPA axis or use of steroidal medications within the previous 3 years.

 known neurological disease or previous brain surgery.

 Major medical conditions or using medication known to influence the HPA or ANS Axis.

 Baldness or hair shorter than 1cm.

 Using color dyes.

 Pregnancy.


Home Oxygen Treatment of Childhood Acute Bronchiolitis

Summary: Background: acute bronchiolitis (AB) is a common reason for hospitalization of infants in all population groups, and is usually due to respiratory syncytial virus (RSV) infection. The main cause for hospitalization is often a need for oxygen, but can also include high fever (with a suspected secondary bacterial infection) or increasing respiratory distress. In a minority of cases (some of which can be identified in advance by defining risk groups) a serious illness may develop, including risk of respiratory failure and death. Most cases will just require supplemental oxygen and suction of secretions from the nose (as listed in the recommendations of the American Academy of Pediatrics - AAP). However, this apparently simple treatment still requires continued hospitalization. This results in a sharp increase in bed occupancy in Israeli hospital pediatric departments in the winter months. In recent years two studies from developed countries have been published where safety has been demonstrated for home oxygen treatment for babies with AB. However, feasibility studies have not been published yet, for example for populations living in poor conditions. The General Health Services (Klalit) in Israel provides integrated hospital and community health service to the majority of the population living o in our region, thus presenting an opportunity for optimal interventions related to this disease.
Inclusion criteria: inclusion criteria:

 Age: 2-24 months, but age postconception of over 44 weeks.

 Ac. bronchiolitis clinical diagnosis: acute respiratory illness including nasal congestion, coughing and wheezing or crackles simplified, Tachypnea or retractions of the chest.

 X-ray confirms a viral diagnosis of bronchiolitis

 First attack of wheezing

 O2 Saturation < 91% room air while arrival to the ER

 The baby and his family have a way to return to the ER after discharge

 The family lives a distance of less than 30 minutes drive from the center of Emergency Medicine

 The baby lives in an environment with no smoking

 The baby's family is available by phone

 The baby's family is ready for continuous monitoring of the baby at home 11th. Disease severity index (RDSS) of < 4 (see definitions)

Exclusion criteria: :

 Previous morbidity: cardiac, pulmonary, neuromuscular, nutrition (including FTT). And congenital or acquired airway problem.

 Age since conception is less than -44 weeks.

 History of apneas

 Bacterial pneumonia suggested by a localized-focal finding on X-ray

 Previous wheezing attack

 O2 Saturation > 92% on room air

 Family has no transportation available follow-up visits

 The family lives at a distance greater than 30 minutes drive from the medical facility

 The baby was treated with steroids for this attack

 There is no continuous monitoring of the baby at home

['Bronchiolitis, Viral', 'Home Nursing']


A Study of JNJ 10229570-AAA to Evaluate Safety and Tolerability in Japanese Participants With Acne Vulgaris

Summary: The purpose of this study is to evaluate the safety and tolerability of JNJ 10229570-AAA after a single topical application of JNJ 10229570-AAA 1.2% and 3.6% cream in Japanese participants with acne.
Inclusion criteria: inclusion criteria:

 Have Acne vulgaris, presenting at least inflammatory lesion on the face

 Body mass index between 18.0 and 30.0 kg/m2 (inclusive), and body weight not less than 50 kg (man) or 45 kg (woman)

 Blood pressure between 90 and 140 mmHg systolic (inclusive), and no higher than 90 mmHg diastolic

 Electrocardiogram (ECG) consistent with normal cardiac conduction and function

 Non-smoker

 Adequate contraception method for both men and women. If a woman, must have a negative pregnancy test

 Signed an informed consent document

Exclusion criteria: :

 History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results

 Clinically significant abnormal values for hematology, biochemistry or urinalysis

 Clinically significant abnormal physical examination, vital signs or ECG - Use of any prescription or nonprescription medication within 14 days before the study treatment

 History of drug or alcohol abuse within the past 5 years

 Drug allergy or drug hypersensitivity

 Blood donation, depending on the volume of blood collection

 Positive test for human immunodeficiency virus (HIV), hepatitis B or C, or syphilis

 Dermatological disease at application site

 Photosensitivity

 Exposure to excessive or chronic ultraviolet (UV) radiation (i.e., sunbathing, tanning salon use, phototherapy) within 4 weeks prior to study treatment or planned during the study period

['JNJ 10229570-AAA 1.2%', 'JNJ 10229570-AAA 3.6%', 'Color-matched vehicle containing 0 mg of JNJ 10229570-AAA']


Effect of IV and Oral Esomeprazole in Prevention of Recurrent Bleeding From Peptic Ulcers After Endoscopic Therapy

Summary: The investigators previously showed that the use of a high-dose intravenous PPI regimen after endoscopic control of bleeding from peptic ulcers reduced rate of recurrent bleeding, decreased the need for endoscopic and surgical interventions and in general improved patients' outcomes. A trend towards reduced mortality associated with the use of high-dose intravenous PPI was also observed. Recent clinical trials from Asia have provided evidence that high-dose oral PPIs are associated with a reduction in rebleeding. Current meta-analysis suggests that both high dose (intravenous) and low dose (oral) PPIs effectively reduce rebleeding vs placebo. However, there has been no clinical study to compare IV infusion to oral PPI in this patient population.~The purpose of this clinical study is to compare the efficacy and safety of intravenous and oral Esomeprazole in patients with peptic ulcer hemorrhage who are at risk for recurrent bleeding. The investigators hypothesize that using IV infusion is superior to oral PPI.
Inclusion criteria: inclusion criteria:

 Age ≥ 18

 Confirmed ulcer bleeding with Forrest Ia, Ib, IIa, IIb

 Endoscopic hemostasis achieved

 Informed consent obtained

Exclusion criteria: :

 No consent

 Forrest II c, III (clear ulcer base/flat spot and no active bleeding, i.e., minimal risk for rebleeding)

 Unsuccessful endoscopic treatment (i.e., injection and/or thermal coagulation for the initial bleeding) or severe bleeding that immediate surgery is indicated

 Moribund patients in whom active treatment of any form is not considered.

 Polytrauma, severe injury, unconsciousness, burns, or need for continuous artificial ventilation

 Upper GI malignancy or disseminated malignant disease

 Esophageal varices

 A Mallory-Weiss lesion

 Phenytoin or theophylline treatment

 Uses of PPI or H2RAs within 3 days of admission, including uses at Emergency Department N.B. Usage of aspirin or NSAID is not an

['Oral esomeprazole', 'Intravenous Esomeprazole']

Oral esomeprazole
Intravenous Esomeprazole


Effectiveness Study of the BioVac Direct Suction Device in Upper Gastrointestinal Bleeding

Summary: Upper endoscopy is performed for upper gastrointestinal bleeding (bleeding in the esophagus, stomach, or part of the duodenum) to identify and potentially treat the cause of bleeding. However, blood clots often make visualization difficult during endoscopy. The current practice is to try to wash off and suction up these blood clots with the endoscope. However, this is often not successful due to blood clots blocking the suction channel.~A new device has been approved by Health Canada that attaches to the endoscope and helps prevent blockage. It is believed that this device will help doctors suck out blood clots and potentially improve visualization, identification of the cause of bleeding, and possibly health outcomes, although this has never been proven. The purpose of the this clinical trial is to test whether the device works and whether it can help patients with this type of bleeding.
Inclusion criteria: inclusion criteria

 Patients presenting with fresh blood hematemesis, coffee ground emesis, or melena

 Patients with hematochezia and hypotension (systolic blood pressure < 90 mm Hg) or tachycardia (heart rate > 110 beats per minute)

Exclusion criteria:

 Identification of a bleeding source within the first 5 minutes of the upper endoscopy or no blood seen in the upper GI tract as these patients do not require additional suctioning.

 Age < 18.

 No endoscopy was performed.

 Endoscopy previously performed for current episode of UGIB.

 Patients unable to consent and who do not have a substitute decision maker.

['BioVac Direct Suction Device', 'Standard Endoscopy Suction']

BioVac Direct Suction Device
Standard Endoscopy Suction


Pot-Kast: Thrombosis Prophylaxis After Knee Arthroscopy

Summary: Currently, guidelines and clinical practice differ considerably with respect to use of anticoagulant treatment after arthroscopy of the knee. Trials that have been carried out were aimed at efficacy only, had small sample sizes and therefore mainly used asymptomatic thrombosis as endpoint. From these trials an overall risk benefit-balance could not be established, hence the current controversy. In the proposed study the investigators will use relevant symptomatic endpoints in a large cohort of patients. Furthermore the investigators will follow subjects with an adverse event for a longer period, during which the investigators will assess the long term sequelae of these events. Lastly, the investigators will determine high risk groups that will benefit most from anticoagulant treatment.~Objective: Comparative effectiveness research to determine cost-effectiveness of two existing policies, i.e. treatment with low molecular weight heparin (LMWH) after arthroscopy of the knee. In addition the investigators will investigate personalized prophylaxis based on genetic and acquired risk factors.
Inclusion criteria: inclusion criteria:

 Meniscectomy

 Diagnostic Arthroscopy

 Removal of corpora libera

Exclusion criteria: :

 Contra-indications for LMWH use (recent major bleeding, bleeding disorder, allergy)

 Pregnancy

 Pre-existent indication for anticoagulation therapy, either LMWH or vitamin K antagonists.

 History of venous thromboembolism (indication for anticoagulation therapy for prophylaxis of recurrence)

 Mental of physical disability to fulfill study requirements

 Insufficient knowledge of the Dutch language

 Previous participation in the Pot-(K)Cast study

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

Deep Venous Thrombosis
Pulmonary Embolism


Sodium Supplementation and Growth in Very Low Birth Weight Infants

Summary: Adequate growth during the neonatal period is critical for optimal long term outcomes. Despite maximal calorie intake, sixty percent of very low birth weight infants still fail to thrive suggesting that factors other than total calorie intake are important in ensuring consistent weight gain. Several reports have indicated a positive sodium balance is critical in ensuring good weight gain in very low birth weight infants, however these infants are susceptible to low serum sodium concentrations. Urine sodium values are sometimes used to diagnosis of hyponatremia or negative sodium balance after the first two weeks of life, but there is no evidence for this practice in preterm neonates. Our central hypothesis is that early supplementation with sodium will ensure positive sodium balance in very low birth weight infants and will result in optimal weight gain and enhanced long term outcomes. Secondarily we hypothesize that low sodium concentrations in the urine will not correlate with low serum sodium values.
Inclusion criteria: inclusion criteria:

 infants born at less than 32 weeks postmenstrual age

Exclusion criteria: :

 infants with major malformations deemed incompatible with life disease states characterized by edema renal failure, defined as an increase in serum creatinine by 0.5 mg/dl/day or urine output less than 0.5 ml/kg/hour


A Comparison of Insoles Used to Prevent Neuropathic Diabetic Foot Ulceration

Summary: Importance of the topic:~Lower extremity amputation is a costly complication of diabetes for both the NHS and the patient. Amputation may be avoided if the preceding foot ulceration can be prevented. One method of reducing the risk of ulceration in the neuropathic foot is through the provision of therapeutic insoles. The type of insole prescribed (prefabricated verses custom made) is currently based on anecdotal evidence. The idea held by many practitioners that the custom made insole is superior in its effect remains speculation, unsupported by the evidence. In the absence of economic analysis, the available data suggests that the custom insole is substantially more expensive to the NHS. This study, to determine which of two types of insole used in therapeutic shoes reduces peak pressure more in the at-risk diabetic foot, is therefore a very important topic and will provide both useful evidence for the NHS podiatry services. It is of course also very important for patients with diabetes as the personal suffering of those undergoing amputation is immense.~The study is a single blind randomised controlled trial comparing custom made with 'off the shelf' insoles.
Inclusion criteria: inclusion criteria:

 diagnosed as having Type 1 or 2 diabetes mellitus, (recorded within the case notes and confirmed by participant),

 diagnosed with diabetic peripheral neuropathy

 palpable or biphasic pulses

 intact from lower limb vascular or neuropathic ulceration, scoring Grade 0 on the Wagner classification for foot ulcer

 able to walk a minimum of 10 metres unaided

 willing to comply with the requirements of the study.

Exclusion criteria: :

 presented with current or recently healed ulceration less than 6 months prior to study enrolment,

 severe fixed mid-foot or rearfoot deformity e.g. charcot joint, unsuitable for prefabricated insoles and non- bespoke footwear,

 history of major bone or joint surgery of the lower limb including major amputation

 unable to comprehend simple instructions and comply with the study protocols and procedures.


A Gene Transfer Therapy Study to Evaluate the Safety of SRP-9004 (Patidistrogene Bexoparvovec) in Participants With Limb-Girdle Muscular Dystrophy, Type 2D (LGMD2D)

Summary: This is an open-label, dose escalation gene transfer therapy study evaluating the safety of SRP-9004 (patidistrogene bexoparvovec) via isolated limb infusion (ILI) administration in approximately 6 participants with LGMD2D.
Inclusion criteria: Key inclusion criteria:

 Cohort 1A must be adult and wheelchair-dependent; Cohorts 1B and 2 will be participants of age 7 or older.

 Confirmed alpha-sarcoglycan deficiency or identified sarcoglycan alpha (SGCA) deoxyribonucleic acid (DNA) mutation.

 Participants enrolled in Cohorts 1B or 2 must be able to walk independently, but must exhibit signs of lower extremity weakness (that is, a Gowers' sign, use a handrail for climbing stairs) and walk ≤80% of predicted distance on the 6 minute walk test (6MWT) based on normative data.

 Key
Exclusion criteria: :

 Active viral infection based on clinical observations.

 The presence of SGCA mutations without weakness or loss of function.

 Symptoms or signs of cardiomyopathy.

 Serological evidence of human immunodeficiency virus (HIV), Hepatitis B, or C infection.

 Diagnosis of (or ongoing treatment for) an autoimmune disease.

 Participants with AAVrh74 or AAV8 binding antibody titers ≥ 1:50 as determined by enzyme-linked immunosorbent assay (ELISA) immunoassay.

 Other inclusion/

['Limb-Girdle Muscular Dystrophy, Type 2D']


The Impact of Arousal Threshold in Obstructive Sleep Apnea

Summary: The investigators hypothesis is that obstructive sleep apnea (OSA) patients with a low arousal threshold may wake up too early during a respiratory event, before upper airway muscles can be activated to achieve stable ventilation. Thus, strategies to manipulate the respiratory arousal threshold could potentially improve the quality of sleep and sleep disordered breathing. Agents that raise arousal threshold are therefore likely to benefit some patients with OSA. The overall goal of this project is to determine the importance of the arousal threshold in OSA, determine which patients might benefit from a raised arousal threshold, and test this hypothesis by using pharmacological manipulation of the arousal threshold to achieve this goal.
Inclusion criteria: inclusion criteria:

 Ages 18-70 years

 sleep study (with apnea hypopnea index>5)

 Diagnosis of obstructive sleep apnea

Exclusion criteria: :

 Any known unstable cardiac (apart from treated hypertension), pulmonary (including asthma), renal, neurologic (including epilepsy), neuromuscular, or hepatic disease.

 Susceptible to stomach ulcers.

 Pregnant women or Nursing mothers

 Using positive airway pressure (PAP) therapy over one week or longer

 Body weight <55kg

 History of hypersensitivity to Afrin, Lidocaine and/or Donepezil

 History of bleeding diathesis and/or gastrointestinal bleeding.

 Use of any medications that may affect sleep or breathing.

 A psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders.

 Substantial cigarette (>5/day), alcohol (>3oz/day) or use of illicit drugs.

 More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day.

 Deprived from sleep in the recent one week

 Desaturations to below 70% lasting greater than 10 seconds in duration per event in the sleep study (without Oxygen).


Sleep Health in Preschoolers: a Randomized Controlled Trial

Summary: The SHIP study is a randomized controlled trial of an intervention for preschool children with sleep problems, in which we aim to give parents the knowledge, motivation, and skills necessary to set goals, problem-solve, and improve their child's sleep. In collecting three years of follow-up data, we will be able to determine the impact of the SHIP intervention on childhood sleep problems, obesity, academic achievement, and emotional and behavioral problems, as well as parental stress and daytime tiredness. This study has the dual potential to expand treatment resources for young children with behavioral sleep problems and to increase our scientific understanding of the long-term consequences of early childhood sleep problems.
Inclusion criteria: inclusion criteria:

 Age 30-71 months

 Child behavioral sleep problem, as demonstrated by a score on the Children's Sleep Habits Questionnaire (CSHQ) of at least 50, or a score of 41-49 and reported weeknight sleep of 9hrs or less per night

 English speaking parent or guardian

Exclusion criteria: :

 Sleep disordered breathing, as demonstrated by a score on the CSHQ of at least 5

 Currently taking prescribed sleep medications, psychostimulants, and/or systemic corticosteroids

 Serious medical conditions likely to affect sleep, including diabetes or cancer

 Major cognitive or developmental disorder, including autism spectrum disorder

['SHIP (Sleep Health in Preschoolers)', 'SHIP Control Arm']

SHIP (Sleep Health in Preschoolers)
SHIP Control Arm

['Sleep Initiation and Maintenance Disorders']


Hospitalization at Home of Elderly Patients With Heart Failure

Summary: Aim of the study was to evaluate the efficacy of hospital-at-home treatment compared with inpatient care in selected elderly patients with acute exacerbation of chronic heart failure (CHF).
Inclusion criteria: inclusion criteria:

 Acute exacerbation of chronic heart failure,

 Age over 75,

 Appropriate care supervision at home,

 Telephone connection,

 Living in the hospital-at-home catchment area and informed consent.

Exclusion criteria: :

 Absence of family and social support;

 Patients who need mechanical ventilation,

 Severe dementia,

 End-stage cancer,

 History of severe renal impairment or hepatic failure with ascitis.

['Treatment of elderly patients in a GMW', 'Treatment of elderly patients in GHHS']

Treatment of elderly patients in a GMW
Treatment of elderly patients in GHHS


A Double-blind, Randomised, Parallel Group,Comparative Study With Rose-hip Liquid and Placebo Given to Healthy Volunteers in the Winter Season Aiming to Evaluate the Occurences of Flu and Catching a Cold

Summary: The trial is an investigator-initiated, double-blind, randomized, placebo-controlled phase III study.~After the patient has receiving information about the study and after given written informed consent, the patient will be screened.~The patient's medical history and demographic information will be recorded. The patient will then be asked questions in accordance to the study questionnaires, and they will also be asked to complete questionnaires regarding quality of life - and finally they be instructed on how to complete the diary.~All patients are randomized to receive standardized rose hip liquid or matching placebo. The subject is instructed to take the liquid form of rose hips in the morning and evening meal. The subject will also be advised to call the clinic if there is an acute attack of cold and / or flu because they must then increase the in-take of study treatment to 3 double dose for 5 days and then return to normal dose.~The subject will then be asked a series of questions under study questionnaires, and be instructed in how questionnaires (SF-12) and diary filled. This is to provide security to the validation output values Investigator or study nurse will take telephone contact with the subject once a month, subjects will be asked about how things are going and to remember to take the liquid and whether they have completed the diary.~The last patient visit will take place after 6 months. Any side effects will be reported to and reviewed with HybenVital ApS in collaboration with medical experts.
Inclusion criteria: inclusion criteria:

 First Men and women aged 50 + years

 It is accepted that the subjects can be treated for medical diseases.

 It is also accepted that the subjects receiving daily medication such as diuretics and medication for Hypertension, hypercholesterolemia and blood glucose-lowering treatment, medicine that strengthens the heart, symptom-relieving medication for joint disease, etc.

 Subjects may also use n-3 fatty acids (fish oil), as long as the fixed dosage.

Exclusion criteria: :

 Subjects who have been treated with rose hip extracts or powder within 3 months before screening.

 Subjects who have been treated with ginger, avocado / soy, large doses of vitamins (including vitamin C) or other known dietary supplements within 3 months before screening

 Subjects that have been deemed to be have a hard time collaboration

 Subjects who abuse narcotics.

 Subjects who abuse alcohol

 Subjects with a current mental illness

 Subjects with known allergy to rose hips

 Subjects participating in another clinical trial, or have participated in another clinical trial within 3 months before this trial started.


Treatment of Children With Obstructive Sleep Apnea and Laryngomalacia: the Role of Laser Supraglottoplasty

Summary: This is a research study of the effect of treating laryngomalacia (floppiness of tissue on top of the voice box that can possibly block breathing) found in association with obstructive sleep apnea (blockage of breathing while sleeping).~The purpose of this study is to determine which is the best treatment for children with obstructive sleep apnea and laryngomalacia: adenotonsillectomy alone or adenotonsillectomy with laser supraglottoplasty (removal of tissue on top of the voice box to open the airway).
Inclusion criteria: inclusion criteria:

 1 year old to 18 years of age, clinical signs or symptoms of obstructive sleep apnea (snoring, witnessed apneas, daytime somnolence, restless sleeping, or cyanosis), abnormal polysomnogram (mild, moderate, or severe OSA) including CO2 measures, failed or refused trial of CPAP, or not recommended by their pulmonologist or primary care doctor.

Exclusion criteria: :

 prior laser supraglottoplasty, prior adenoidectomy prior tonsillectomy, stridor with cyanosis or apnea, severe respiratory distress, recurrent pneumonia (x3), Laryngeal cyst, vocal cord (VC) Paralysis, airway vascular malformation, neoplasm, subglottic hemangioma, paradoxical vocal cord (VC) motion, posterior glottic stenosis, glottic webs, discoordinate pharyngolaryngomalacia, or refusal to participate.

['supraglottoplasty with laser', 'supraglottoplasty with laser']

supraglottoplasty with laser
supraglottoplasty with laser

['Sleep Apnea, Obstructive', 'Respiration Disorders']

Sleep Apnea
Obstructive
Respiration Disorders


Low Back Pain Patient Education Evaluation

Summary: Back pain is one of the most common of all symptoms. It is also a great cause of days lost from work and visits to health care providers. This study will develop and evaluate an approach to low back pain that allows subjects to talk with each other and with health professionals via an Internet discussion group. Results we will look at include health behaviors, such as exercise; health status, such as pain and disability; and health care use, such as number of visits to doctors and other health care providers. Anyone 18 years old or older who lives in the United States and has ongoing Internet access can take part in the study. All subjects must have back pain and meet the eligibility criteria listed below.
Inclusion criteria: inclusion criteria:

 Must live in the United States

 Must understand and write English

 Must have access to a computer with e-mail and expect to have this access for at least 3 years

 Must be 18 years old

 Must have seen a doctor for back pain at least once in the past year

Exclusion criteria: :

 Pregnancy

 Back surgery in the past 6 months

 Expectation of having back surgery in the next 6 months

 Back pain due to a car accident or other major injury within the last 6 months

 Back pain or sciatica due to systemic disease (inflammatory rheumatic diseases, tumor, or other)

 Major physical or mental health condition for which one is currently being treated that severely limits daily activities

 Terminal illness

 Receiving disability or workers compensation insurance payments for back pain or sciatica

 Presently involved in legal proceedings because of back pain or sciatica

 Difficulty with bladder or bowel control that began with back pain or sciatica

 No visits to a doctor in the past year for back pain or sciatica

 Numbness in crotch area that began with back pain or sciatica

 Age under 18


The Use of Low Molecular Weight Heparin in Hemodiafiltration

Summary: Low molecular weight heparin (LMWH) is injected in the dialysis circuit at the start of the session. In the present study we compare 3 different methods of injection of LMWH: parameters of dialysis efficiency and clotting are measured. The study lasts 3 sessions for each patient.
Inclusion criteria: inclusion criteria:

 chronic kidney disease stade V treated with hemodiafiltration

 age >18 year

 Hematocrit > 30%

Exclusion criteria: :

 treatment with vitamin K antagonists

 treatment with other anti-coagulants or heparin besides the heparin used during dialysis

 active bleeding, infection or malignancy

 heparin associated allergy

 hepatic failure

 trombocytopenia < 120.000/µl

['At start of the session, at the inlet line', '5 minutes after the start of the session, at the inlet line', 'At the start of the session, at the outlet line']


A Repeated Instruction by Telephone on the Day Before Colonoscopy to Patients Undergoing Colonoscopy

Summary: Cell phone retell the instruction of bowel preparation on the day before colonoscopy would help patient to prepare for colonoscopy and improve the quality of the bowel preparation.
Inclusion criteria: inclusion criteria:

 patients undergoing colonoscopy

Exclusion criteria: :

 disturbance of water and electrolyte

 history of colorectal surgery

 severe colonic stricture or obstructing tumor

 known or suspected bowel obstruction or perforation

 toxic colitis or megacolon

 dysphagia

 compromised swallowing reflex or mental status

 significant gastroparesis or gastric outlet obstruction or ileus

 severe chronic renal failure (creatinine clearance <30 mL/minute)

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

 uncontrolled hypertension (average systolic blood pressure >170 mm Hg, average diastolic blood pressure >100 mm Hg)

 pregnant or lactating women

 patients who cannot give informed consent


Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization

Summary: In patients with ST-elevation myocardial infarction (STEMI) the primary treatment is acute angioplasty of the acute occlusion (culprit lesion). In STEMI patients with multi vessel disease (MVD) no evidence based treatment of the non-culprit lesions exists. We aim to provide evidence as to whether full revascularization or revascularization of the culprit lesion only provides the best prognosis for the patient.
Inclusion criteria: inclusion criteria:

 Age ≥ 18 years.

 Acute onset of chest pain of < 12 hours' duration.

 ST-segment elevation ≥ 0.1 millivolt in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block.

 Culprit lesion in a major native vessel.

 MVD (non-culprit vessels with angiographic stenosis >50%)

 Successful primary PCI

Exclusion criteria: :

 Pregnancy.

 Known intolerance of acetylsalicylic acid, clopidogrel, heparin or contrast.

 Inability to understand information or to provide informed consent.

 Haemorrhagic diathesis or known coagulopathy.

 Stent thrombosis

 Significant left main stem stenosis

 Cardiogenic shock at admittance

['Percutaneous coronary intervention', 'FFR']

['ST-elevation Myocardial Infarction', 'Multi Vessel Disease']

ST-elevation Myocardial Infarction
Multi Vessel Disease


Long-Term Outcome of Children and Adolescents With Anti-Phospholipid Antibodies

Summary: This is a study about why some people have certain types of proteins in their blood, called anti-phospholipid antibodies. The presence of these antibodies and associated complications (e.g. blood clots) are known to change over time. The purpose of this study is to evaluate these changes and improve our ability to determine the long-term outcome of affected individuals.
Inclusion criteria: inclusion criteria:

 Age: Less than 21 years at baseline exam

 Diagnosis: patients must meet criteria for one of five diagnostic categories based on classification according to three parameters; aPL positivity, APS criteria, and SLE criteria.

 The five diagnostic categories are:

 SLE with no aPL

 SLE with aPL, but without manifestations of APS

 SLE-like APS

 SLE with APS

 Primary APS.

Exclusion criteria: :

 none


Safety Study of Live Attenuated Oral Shigella (WRSS1) Vaccine in Bangladeshi Adults and Children

Summary: This is a research study about an experimental (investigational) oral Shigella sonnei - Walter Reed S. sonnei (WRSS1). WRSS1 is a live vaccine that is being made to prevent disease from Shigella, which causes bloody, watery diarrhea. Infants and children living in developing countries experience the greatest consequences of this disease. The purpose of this study is to find a dose of the vaccine that is safe, tolerable, and develops an immune response. About 39 healthy adults, ages 18-39, and 48 healthy children, ages 5-9, will participate in this study. Once the vaccine is proven safe and tolerable in adults, then it will be tested in the children. This study will require volunteers to stay in the research facility for several nights for the first dose; they will not be required to stay overnight for the second and third doses. Participants will be assigned to receive 1 of 3 vaccine dose levels by mouth. Study procedures include: stool samples, blood samples and documenting side effects. Participants will be involved in study related procedures for about 8 months.
Inclusion criteria: inclusion criteria:

 Healthy male or female adults from 18-39 years old, inclusive

 General good health as determined by the screening evaluation no greater than 30 days before admission

 Properly informed about the study, able to understand it and sign the informed consent form

 Normal bowel habits (< 3 grade 1 or 2 stools each day; ≥ 1 grade 1 or 2 stools every 2 days)

 Free of obvious health problems as established by medical history and clinical examination before entering into the study.

 Available for the entire period of the study and reachable by study staff throughout the entire follow-up period

 Females of childbearing potential who are willing to take a serum pregnancy test at screening and urine pregnancy tests before each vaccination. Pregnancy tests must be negative before each vaccination. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is also acceptable.

 Signed Informed Consent

Exclusion criteria: :

 Presence of a significant medical or psychiatric condition that in the opinion of the Investigator precludes participation in the study

 Known infection with Hepatitis C or Human Immunodeficiency Virus (HIV)

 History of congenital abdominal disorders, intussusception, abdominal surgery or any other congenital disorder.

 Participation in research involving another investigational product (defined as receipt of investigational product) 30 days before planned date of first vaccination or concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational product

 Clinically significant abnormalities on physical examination

 Clinically significant abnormalities in screening hematology, serum chemistry, or urinalysis as determined by the PI or the PI in consultation with the Study Physician

 History of febrile illness within 48 hours prior to vaccination

 Known or suspected impairment of immunological function based on medical history and physical examination

 Prior receipt of any Shigella vaccine

 Fever at the time of immunization. Fever is defined as a temperature ≥ 37.5 degrees Celsius (99.5 degrees Fahrenheit) on axillary, oral, or tympanic measurement

 Clinical evidence of active gastrointestinal illness

 Prior receipt of a blood transfusion or blood products, including immunoglobulins

 Presence of any significant systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would endanger the participant's health or is likely to result in non-conformance to the protocol.

 History of any neurologic disorders or seizures.

 Acute disease at the time of enrolment

 Evidence of current excessive alcohol consumption

 Evidence of current illicit drug use or drug dependence

 Current use of iron or zinc supplements within the past 7 days; current use of antacids (Histamine H2-receptor antagonists (H2 blockers), Omeprazole, over the counter (OTC) agents) or immunosuppressive drug

 Allergy to quinolone, sulfa, and penicillin classes of antibiotics

 History of any of the following conditions within the past 10 years:

 Arthritis (two or more episodes of joint pain and swelling)

 Gastrointestinal disease (diagnosed by a doctor as having irritable bowel disease, Crohn's disease, ulcerative colitis (biopsy confirmed), celiac disease, stomach or intestinal ulcers

 Dyspepsia (indigestion or heartburn requiring medication more than once per week)

 History of gallbladder disease

 History of chronic heart disease

 Any conditions which, in the opinion of the investigator, might jeopardize the safety of study participants or interfere with the evaluation of the study objectives

 Receipt of antimicrobial drugs for any reason or a fever ≥ 38 degrees Celsius within 7 days before vaccination

 History of diarrhea during the 7 days before vaccination.

 Has any household member(s) who is immunocompromised or under the age of 2 years old.


Treatment of Iron Deficiency Anaemia in Inflammatory Bowel Disease With Ferrous Sulphate

Summary: Iron deficiency anaemia is common in inflammatory bowel disease (IBD), affecting at least 20% patients at any one time. Hepcidin, a recently described anti-microbial peptide synthesized by the liver, is a key regulator of iron homeostasis. It interferes with absorption of iron into enterocytes, macrophages and hepatocytes by binding to ferroportin. Hepcidin levels rise when total body iron levels rise and protect against iron overload; conversely, in iron deficiency, levels are low. Hepcidin levels also rise under the influence of interleukins (IL)-6 and -1, a factor likely to contribute to iron deficient erythropoesis in active IBD. Whether hepcidin levels predict resistance to oral iron therapy in IBD is unknown, though it may impair its immediate oral absorption. Adult IBD patients who are anaemic report quality of life and fatigue scores comparable to those seen in malignancy.~IBD diagnosed in adolescence interferes with growth, education and employment as well as psychosocial and sexual development. Not surprisingly, adolescents with IBD have a high prevalence of psychological distress, particular depression. Limited historical, and our own data suggest that children and adolescents with IBD are more anaemic than adults, and less often treated with oral iron. What is not clear is whether the apparent under-utilisation of oral iron in paediatric care is because of a perceived lack of benefit or doctors' concerns about possible side effects including worsening disease activity.~To address these questions, the investigators propose a comparative study of 6 weeks of oral iron supplementation in adolescents and adults with iron deficiency anaemia in IBD. Patients will be given oral iron supplementation. Before and after iron therapy, the investigators shall assess haemoglobin concentrations; IBD activity; quality of life (QOL), perceived stress, mood and fatigue; iron metabolism, including serum hepcidin.
Inclusion criteria: inclusion criteria:

 Patients with proven iron deficiency anaemia on World Health Organisation (WHO)criteria Patients aged 13 - 18 will be considered adolescents, and aged >18 as adults.

Exclusion criteria: :

 Anaemia caused by B12 or folate deficiency, or secondary to drugs used to treat IBD; haemoglobinopathies or myelodysplasia; severe cardiopulmonary, hepatic or renal disease; severe cardiopulmonary, hepatic or renal disease; pregnancy and breast feeding females.

['Ulcerative Colitis', "Crohn's Disease"]


A Multi-Center Trial of the ProLung Test™

Summary: The primary Study hypothesis is that the ProLung Test will demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer. A statistically significant result will indicate that patients with a high ProLung Test result have a greater risk of developing lung cancer than patients with a low test result.~There are three Specific Aims of this study:~Optimize and confirm the stability of the ProLung Test risk-stratification algorithm in patients with a diagnosis.~Externally validate the efficacy of the ProLung Test risk-stratification algorithm by comparing the test result to the conclusive patient diagnosis.~Assess the safety and tolerability of the ProLung Test procedures.~Study Design This Study consists of two distinct phases, Stabilization and Validation. The Study will collect data from multiple sites (3 to 12), and each site may enroll patients and collect data for the Stabilization and Validation Phases with a minimum of three sites for the Validation Phase.
Inclusion criteria: inclusion criteria:

 Subjects who meet all of the following criteria may be enrolled in this Study:

 Subject is male or female, age 18 or older.

 Subject has undergone CT scan of the lung(s) that indicates one or more nodules or lesions suspicious for lung cancer.

 Subject's pulmonary nodule or lesion is greater than 4mm. Size is determined by the largest nodule or lesion dimension identified from CT imaging.

 Subject meets one or more of the following conditions:

 indicated for a tissue biopsy

 indicated for surgical resection of the lung

 Subject must be able to receive a ProLung Test

 within 60 days of abnormal CT (Inclusion Criterion 2 & 3)

 within 60 days prior to the tissue biopsy or surgical resection (Inclusion Criterion 4).

 Subject is capable of understanding and agreeing to fulfill the requirements of this Protocol.

 Subject has signed the IRB/IEC approved Informed Consent Form (ICF).

Exclusion criteria:

 The following criteria will disqualify a subject from enrollment into this Study:

 Subject has an implanted electronic device in the chest.

 Subject receiving therapy for suspected chest infection such as fungal infection or tuberculosis.

 Subject with diagnosed malignancy other than lung cancer, non-melanoma skin cancer or any cancer in which the Principal Investigator does not suspect metastatic disease to the lung, who has 2 or more suspicious pulmonary nodules.

 Subject has received an invasive medical or surgical procedure within the thoracic cavity within 30 days prior to the ProLung Test or within the previous 14 days for a bronchoscopic procedure.

 Subject presents with an anomalous physical or anatomical condition that precludes ProLung Test measurement.

 Subject will have undergone unusually strenuous exercise within 24 hours.

 Subject who has significant systemic diseases such as uncontrolled diabetes, advanced heart failure, or a recent myocardial infarction, or other medical condition such as severe morbid obesity that in the judgment of the Principal Investigator would make him/her unsuitable for the Study.

['Solitary Pulmonary Nodule', 'Multiple Pulmonary Nodules']

Solitary Pulmonary Nodule
Multiple Pulmonary Nodules


Transmission Reduction and Prevention With HPV Vaccination (TRAP-HPV) Study

Summary: Human papillomavirus (HPV) is a member of the Papillomaviridae family of DNA viruses that is capable of infecting humans. HPV infection can cause cancers of the cervix, vulva, vagina, and anus in women or cancers of the anus and penis in men. Two prophylactic vaccines have been proven to be highly effective in preventing the acquisition of HPV infection and the genital precancerous lesions caused by it. However, we do not know yet if a previously infected individual, once vaccinated, would be less infective to her or his sexual partner. We plan to conduct a study, called Transmission Reduction And Prevention with HPV vaccination (TRAP-HPV) study to answer this question. It will include 500 sexually active couples* (total of 1000 individuals) in university student health clinics in Montreal (age 18-45 years). It will be a randomized placebo-controlled, double-blinded intervention trial. Study participants will be followed up to 12 months. Behavioural and biological data will be collected at the time of study enrolment, then at months 2, 4, 6, 9 and 12 post-enrolment. The results of this trial will be invaluable in informing policies regarding vaccination of women and men.
Inclusion criteria: inclusion criteria:

 Couple must have been in a new relationship that started no more than six months prior to study entry

 Both partners plan on remaining in Montreal for at least 1 year

 Plan on having continued sexual contact with partner

 Be willing to comply with study procedures

Exclusion criteria: :

 Volunteers must not have been vaccinated against HPV-Gardasil-9 (both partners)

 Any history of cervical, penile, oral or anal cancers

 Being pregnant or plan on immediately becoming pregnant

['HPV vaccine, Gardasil 9', 'Hepatitis A vaccine']

HPV vaccine
Gardasil 9
Hepatitis A vaccine


The Effect of a Carbohydrate Drink on Cognitive Function and Exercise Performance

Summary: This study will investigate the effects of hydrothermally modified starch (SuperStarch) in adults. SuperStarch, originally developed as a drink for children with glycogen storage disease, is a slow digestible carbohydrate, maintaining blood sugar levels over extended periods. Therefore, it could be beneficial to exercise and mental performance, and could possibly have fat loss effects by increasing feelings of fullness. In this study, measures will be taken in 25 men to assess mental function, appetite, and metabolism to determine the processes involved in possible fat loss.
Inclusion criteria: inclusion criteria:

 healthy, 18 to 35 year old man or woman.

Exclusion criteria: :

 smoker

 pregnancy

 taking part in other research.

 followed a weight loss diet in the previous 6 months.

 history of gastrointestinal, endocrine, cardiovascular disease or diabetes.

 neurological or psychiatric condition that may cause cognitive dysfunction.


Evaluating the Link Between Neighborhood Environments and Obesity Among African American Women

Summary: African American women have higher rates of obesity than women of any other racial or ethnic group in the United States. Obesity can have many causes, including genetic and environmental factors. This study will examine how neighborhood environments influence the occurrence of obesity among African American women.
Inclusion criteria: inclusion criteria:

 Participating in the BWHS study

 Residing in New York, Los Angeles, or Chicago
Exclusion criteria:


Belatacept in Liver Transplant Recipients

Summary: The purpose of this clinical research study is to evaluate the effects of belatacept, relative to tacrolimus, on the incidence of rejection, graft loss and death in subjects receiving a liver transplant
Inclusion criteria: inclusion criteria:

 First time recipient of deceased donor liver transplant

 Age 18-70

 Hepatitis C virus (HCV) positive recipients

 For Long-term extension study-Subjects who have completed one year of study treatment (through Week 52)

 Target Disease Exclusions:

 Donor Exclusions a) Living donors b) ABO-incompatible donor recipient pairs c) Donor age < 12 or > 65 years d) Non heart-beating donors e) Anticipated cold ischemia time > 14 hours f) Donor Disease i) Known Human immunodeficiency virus (HIV) infection ii) Hepatitis B virus (HBV) surface antigen-positive or polymerase chain reaction (PCR)-positive donor if HBV negative recipient iii) HCV antibody-positive or PCR positive donor if HCV negative recipient

 Recipient Exclusions g) Subjects with a history of hypercoagulable state h) Subjects with fulminant hepatic failure i) Subjects receiving a split or reduced liver j) Subjects who are Epstein-Barr virus (EBV) negative

 Medical History and Concurrent Diseases

 Subjects who have received 2 or more consecutive weeks of dialysis 1 month prior to enrollment OR anticipated to have prolonged dialysis post-transplantation

 Subjects with known intrinsic renal disease (e.g., a urine protein/ creatinine ratio > 150 mg/g or the presence of an abnormal number of red blood cells (RBCs) or granular casts in the urine) AND calculated GFR < 40 ml/min/1.73 m^2 body surface area (BSA) (abbreviated Modification of Diet in Renal Disease [MDRD]). Subjects must have a calculated GFR assessment within 1 month prior to enrollment.

 Subjects with known HIV

 Subjects with any prior or concurrent solid organ (e.g., heart, kidney, pancreas) or cell (e.g., islet, bone marrow) transplant or subjects deemed likely to have a second solid organ or cell transplant (e.g., islet, bone marrow) within the next 3 years.

 Subjects with a history of cancer within the last 5 years

 Allergies and Adverse Drug Reactions

 a) Hypersensitivity to any medications that will be used in the protocol

 Prohibited Treatments and/or Therapies

 Subjects receiving immunosuppressive agent(s) (e.g., methotrexate, abatacept, infliximab, etanercept, chemotherapy, etc.) within the past 6 months for other indications such as an autoimmune disease

 Subjects who received maintenance corticosteroids at a dose of > 5 mg/day of prednisone (or equivalent) for at least 7 consecutive days within the prior year for an underlying chronic inflammatory or autoimmune disease

 Subjects who have used any investigational drug within 30 days prior to the Day 1 visit

 Subjects previously treated with belatacept
Exclusion criteria:

['Tacrolimus', 'Basiliximab', 'Belatacept More Intensive (MI)', 'Belatacept Less Intensive (LI)', 'Mycophenolate Mofetil (MMF)']

Tacrolimus
Basiliximab
Belatacept More Intensive (MI)
Belatacept Less Intensive (LI)
Mycophenolate Mofetil (MMF)

['Immunosuppression in Solid Organ Transplant']


In Vivo Hip Fracture Discrimination With Quantitative Computed Tomography (QCT)

Summary: Numerous geometric and bone mineral density (BMD) parameters can be derived from quantitative computed tomography (QCT) images of the proximal femur analyzed using dedicated software. The primary objective is to evaluate the contribution of QCT-image analysis to the prediction of the osteoporotic hip fracture risk, as compared to the reference standard, namely, dual energy X-ray absorptiometry (DXA).~Study hypothesis: For predicting osteoporotic hip fracture, findings from QCT images of the proximal femur analyzed using dedicated software are superior over DXA measurements of proximal femoral BMD.
Inclusion criteria: inclusion criteria:

 Selection of cases: women with hip fracture

 woman aged 60 years and more

 clinical suspicion of osteoporosis based on the following: trivial trauma (fall from the standing position), history of vertebral fracture or visualization of a vertebral fracture by CT

 availability of radiographs of the proximal femur (anteroposterior view of the pelvis mandatory; anteroposterior and lateral views of the fractured hip optional)

 signature by the patient of the informed consent document

Exclusion criteria: :

 patient under 60 years

 current bisphosphonate, oestrogen, or SERM treatment started more than 3 months earlier; or past treatment with these medications stopped less than 6 months earlier

 hip arthroplasty on the other side

 fracture at the site of a bone lesion

 psychiatric disorder that might prevent the patient from giving informed consent or from remaining completely still for about 15 minutes during the investigations

 informed consent document not signed by the patient

 Selection of controls:

 The controls will be women without hip fracture matched on age to the cases.

 inclusion criteria:

 woman aged 60 years and more

 signature by the patient of the informed consent document

['Osteoporosis', 'Proximal Femur Fracture']


Etanercept (Enbrel) for Juvenile Myelomonocytic Leukemia

Summary: Primary Objectives:~1.1 Estimate rate of response and define acute toxicity to etanercept used in an up-front phase II window in newly diagnosed or relapsed JMML.~1.2 Determine if response to Tumor Necrosis Factor (TNF) blockade correlates with genetic basis of Juvenile Myelomonocytic Leukemia (JMML) [mutations in NF1, Ras, SHP2] or levels of TNFa.~1.3 Determine if TNF blockade by etanercept results in inhibition of free levels of TNFa and other cytokines by ELISA and bioassay and improves blood counts.~1.4 Estimate the two year event free survival and overall survival in JMML patients following etanercept and allogeneic hematopoietic stem cell transplantation.
Inclusion criteria: inclusion criteria:

 All children greater than 6 months of age and less than 18 years of age with newly-diagnosed previously untreated or previously diagnosed JMML, which has reoccurred after treatment with chemotherapy, stem cell transplantation, and/or cis-retinoic acid.

 A diagnosis of JMML is confirmed only if the following criteria for JMML are met: a) ALL of the following: Absence of t(9;22) or BCR-ABL by PCR or FISH; Absolute monocyte count >1000 (1 X 109/µL); <20% bone marrow blasts; b) At least 2 of the following: Elevated Hb F hemoglobin; Myeloid precursors in peripheral blood; WBC >10,000 (10 X 109/µL); GM-CSF hypersensitivity in methylcellulose culture of bone marrow progenitors cells.

 Adequate hepatic function (bilirubin equal or less than 2.0 mg/dl; ALT equal or less than 3x normal)

 Adequate renal function (serum creatinine equal or less than 2 x normal)

 Performance Status: Have a Karnofsky score >50.

 Written, informed consent according to institution guidelines.

Exclusion criteria: :

 Pregnant or lactating.

 Receiving any other chemotherapy. Patients must have been off chemotherapy for at least 2 weeks and must have recovered from acute toxicity of all previous therapy prior to enrollment.

 Febrile neutropenia at study entry.


Protein Biomarker Discovery and Validation in Chronic Obstructive Pulmonary Disease (COPD) And Asthma

Summary: The purpose of the study is to better understand proteomics of asthma and COPD, and response to therapy. There are two Phases to this study broken into two arms. In Phase I, we propose is to use discovery proteomics and techniques to identify protein expression signatures. Subjects who complete Phase I are eligible, but not required, to enroll in Phase II. In Phase II, we propose to establish and validate the predictive value of protein signatures for treatment responses using inhaled corticosteroids.
Inclusion criteria: inclusion criteria:

 Criteria for Asthma

 INCLUSION

 History consistent with asthma: episodic wheezing, shortness of breath, or cough

 Airway lability recognized by at least 12% improvement in Forced Expiratory Volume (FEV1) after 2 puffs of beta2 agonist Age >18yrs

 FEV1 >40% predicted

 Never smoker, current smoker, or quit smoking ≥5 years ago Criteria for COPD

 INCLUSION

 History consistent with COPD: dyspnea with exertion, productive cough, progressive course

 Smoking history of at least 20 pack years

 Current smoker or quit smoking ≥5 years ago

 Age >18yrs

 FEV1: Forced Vital Capacity (FVC) ratio < 0.70 following 2 puffs of albuterol

 FEV1 greater than 50% predicted

Exclusion criteria: :

 Exclusion for Asthma EXCLUSION

 Other respiratory illness other than asthma

 Chronic infectious process

 Significant other medical illness

 Inability to consent

 Pregnancy Exclusion for COPD EXCLUSION

 Other respiratory illness other than COPD

 Chronic infectious process

 Significant other medical illness

 Inability to consent

 Pregnancy


Extensive Peritoneal Lavage After Curative Gastrectomy for Gastric Cancer: A Randomised Controlled Trial

Summary: This study is carried out to determine the merit and reliability of extensive intraoperative peritoneal lavage as a preventive strategy~Hypothesis: EPL significantly improve the overall survival of patients by reducing the risk of peritoneal recurrence
Inclusion criteria: inclusion criteria:

 Patients who have T3 (subserosal) or T4 (serosal) disease based on CT scan and intra-operative inspection with any N staging and M0 gastric cancer.

 Patients planned for open or laparoscopic gastrectomy.

 Patients undergoing gastrectomy with curative intent.

 Lower age limit of research subjects 21 years old and upper age limit of 80 years old.

 Ability to provide informed consent

Exclusion criteria: :

 Patients who undergo a palliative gastrectomy.

 Patients who undergo a gastrectomy as emergency.

 Vulnerable persons under age of 21.

 Patients receiving neoadjuvant therapy.

 Patients presented with life-threatening bleeding from tumour

 ASA score of 4 & 5

 Patients with another primary cancer within last 5 years

 Patients with gross peritoneal and liver metastasis at surgery.


The Role of Microparticles as a Biomarker

Summary: The investigators propose to characterize MPs in aHUS and TTP both at the onset and throughout treatment. The investigators believe that the number, size, and cell origin of MPs will differ between these two diseases. The hypothesis is that endothelial derived MPs will be higher in number and comprise a larger portion of the MP population in aHUS and that platelet MPs will comprise a larger number and greater proportion of MPs in TTP. The investigators believe that MP identity and number can be used to reliably differentiate between aHUS and TTP at disease onset.
Inclusion criteria: inclusion criteria:

 Patients with MAHA, TTP, and/or aHUS

Exclusion criteria: :

 Prisoners

['Atypical Hemolytic Uremic Syndrome', 'Thrombotic Thrombocytopenic Purpura', 'Microparticles', 'Microangiopathic Hemolytic Anemia']

Atypical Hemolytic Uremic Syndrome
Thrombotic Thrombocytopenic Purpura
Microparticles
Microangiopathic Hemolytic Anemia


Role of DcR3 in T Cell Activation in SLE and RA

Summary: Decoy receptor 3 (DcR3), a new member of tumor necrosis factor receptor (TNFR) superfamily, is a decoy receptor for FasL and could inhibit FasL-induced apoptosis, has recently been shown to induce costimulation of T cells. Systemic lupus erythematosus (SLE) is an autoimmune disease with pathogenic autoantibodies and immune complexes results from abnormal immune responses including T and B lymphocyte hyperactivity, and formation of pathogenic subsets of autoantibodies. Rhematoid arthritis (RA) is a multi-systemic autoimmune disease characterized by persistent inflammatory synovitis. Activated T lymphocytes infiltration to synovium is strongly correlated with the symptoms. DcR3 mRNA is expressed in peripheral-blood T cells and is up-regulated after antigenic stimulation. The DcR3 gene has been demonstrated to be overexpressed in patients with sclerosis or SLE; however, role of DcR3 in SLE and RA as well as the effects of DcR3 on T cell immune response is still not clear. This study is to investigate role of DcR3-induced T cell activation in SLE and RA. The genetic polymorphisms of DcR3 in association with SLE and RA will be studied to elucidate the genetic factors associated with development of SLE and RA. For further explore the possible molecular mechanisms of elevated DcR3 in association with SLE, we attempt to study whether DcR3 could induce T cell activation via costimualtion and/or inhibit the activation induced cell death (AICD) of activated T cells in SLE and RA. This study will provide a new direction of therapy in reverse T cell hyper-reactivity in SLE and RA.
Inclusion criteria: inclusion criteria:

 SLE, RA

Exclusion criteria: :

 nil


The Impact of Creative Interventions on Symptoms of Postnatal Depression (Cohort Study)

Summary: Post-natal depression (PND) is anticipated to affect 12.9% of new mothers with at least 75,000 cases per year in the UK alone. However, despite this, there is currently a worrying lack of support for new mothers, with data suggesting that 64% of healthcare trusts in the UK do not have a strategy for treating PND, and flaws in the current pharmacological and psychological treatment models. Consequently, research into promising psychosocial interventions such as music is critical to developing new paradigms for treating PND.~This project is an ambitious programme of research that investigates links between the mental health of women in the later stages of pregnancy and first 9 months post birth and their use of psychosocial interventions including music.
Inclusion criteria: inclusion criteria:

 Women who are more than 28 weeks pregnant OR up to 9 months post-birth

Exclusion criteria: :

 Outside the limits of the number of weeks pregnant/post birth

 Living outside England

 Refusal to participate


Evaluation of the Ovarian Reserve in Infertile Patients With Endometriosis

Summary: Comparison between Ovarian reserve markers in patients with minimal/mild endometriosis and patients with tubal factor infertility
Inclusion criteria: inclusion criteria:

 Age 18-35 years of age. Written and signed informed consent by the patient to participate in the study. Patients with regular menses, both ovaries, serum TSH within normal range, body mass index (BMI) <30 kg/m2 with normal sperm analysis of the husband.

Exclusion criteria: :

 Patients with previous endocrine disorders. Cases in which the cause for infertility was other than endometriosis (except for patients with tubal obstruction, in the control group).

 Patient with previous surgery for endometriosis.


Rosiglitazone Versus Placebo in Chronic Stable Angina

Summary: We wish to see if the drug rosiglitazone, currently used in the treatment of type 2 diabetes, could be used as a new treatment for angina when compared with placebo in overweight subjects who do not have overt diabetes. The drug will be given for 3 months and the subjects will be have their angina tested, by way of exercise testing, angina quality of life questionnaire and 24-hour ECG monitoring before and after using the drug.
Inclusion criteria: inclusion criteria:

 Chronic stable angina - to see if this improves

 Previous positive exercise tolerance test - to ensure that repeating it yields a result

 Disease not suitable for coronary intervention (Coronary artery bypass grafting or angioplasty) - so that best routine care is not withheld

 Do not have overt diabetes - work on this is being undertaken elsewhere

 Body mass index (BMI) greater than 25

Exclusion criteria: :

 Diabetes mellitus - see above

 Liver failure (ALT>70U/l, AST>80U/l)

 Renal failure (creatinine > 130mmol/l)

 Cardiac failure - rosiglitazone is contraindicated in those with NYHA 3 and 4 cardiac failure

 Physical disability - if it precludes treadmill testing

 Women of child bearing capacity

 Breast feeding mothers

['Angina Pectoris', 'Metabolic Syndrome X']


Bi-Level Positive Airway Ventilation for Acute Chest Syndrome

Summary: Acute chest syndrome (ACS) is a frequent complication of sickle cell disease and is diagnosed by having findings on a chest x-ray and one of the following: chest pain, fever, or trouble breathing. Patients with Acute Chest Syndrome can get very sick and require an exchange transfusion (special large blood transfusion) and mechanical ventilation. Bi-level Positive Airway Pressure (also known as BLPAP or BiPAP) is a device that blows air into a patients lungs via a mask that covers the nose. The goal of this study is to determine whether giving children BiPAP when they have ACS, in addition to providing standard clinical care for ACS, alters the clinical course of these patients. The investigators hypothesize that patients receiving effective BiPAP will have milder clinical courses resulting in shorter hospital stays and fewer transfers to the intensive care unit and exchange transfusions.
Inclusion criteria: inclusion criteria:

 patients diagnosed with Hemoglobin SS (HB SS), the most common type of sickle cell disease

 patients diagnosed with Hemoglobin SC (HB SC), the second most common type of sickle cell disease.

 patients diagnosed with Hemoglobin sickle beta-zero thalassemia ( HB SB0thal) or Hemoglobin sickle thalassemia (HB SBthal)

 Must meet clinical criteria for ACS- an infiltrate on Chest X-ray and one of the following:

 Respiratory symptoms/signs (patients pulse oximetry < 92% or oxygen saturation < 2% below their baseline, tachypnea, cough, and increased work of breathing)

 Fever

 Chest pain AND

 Patients' eligible for a simple transfusion based on one of the following criteria:

 Hypoxemia (patients pulse oximetry < 92% or oxygen saturation < 2% below their baseline)

 Hemoglobin < 5 gm/dl

 Increased work of breathing

Exclusion criteria: :

 Patient requires exchange transfusion within first 24 hours of admission

 Patient requires PCCU transfer within first 24 hours of admission

 Hemoglobin > 9gm/dl secondary to these patients requiring an exchange transfusion

['Bi-level positive airway pressure device', 'Sham CPAP']

['Sickle Cell Anemia', 'Acute Chest Syndrome']


Interleukin-1 Blockade in Recently Decompensated Heart Failure

Summary: The RED-HART is a randomized double-blinded placebo-controlled study of Anakinra (IL-1 blocker) in patients with recently decompensated heart failure to determine the safety and efficacy in terms of aerobic exercise capacity and ventilatory efficiency measured with a cardiopulmonary exercise test.
Inclusion criteria: inclusion criteria:

 All 6 criteria need to be met for enrollment of the patient in the study

 Primary diagnosis for hospitalization is decompensated heart failure established as the finding at admission of all 2 conditions listed below:

 dyspnea or respiratory distress or tachypnea at rest or with minimal exertion;

 evidence of elevated cardiac filling pressure or pulmonary congestion (at least one of the conditions must be met);

 pulmonary congestion/edema at physical exam OR chest X-Ray;

 plasma Brain Natriuretic Peptide (BNP) levels ≥200 pg/ml;

 invasive measurement of left ventricular end-diastolic pressure >18 mmHg or of pulmonary artery occluding pressure (wedge) >16 mmHg.

 The patient has a prior documentation of impaired left ventricular systolic function (ejection fraction <50%) at most recent assessment by any imaging modality (within 12 months).

 The patient is now clinically stable and meets standard criteria for hospital discharge as documented by all the 3 conditions listed below:

 absence of dyspnea or pulmonary congestion/distress at rest;

 absence of pitting edema in the lower extremities, or in any other region;

 stable hemodynamic parameters (blood pressure, heart rate).

 The patient is of age ≥21 years old, and is willing and able to provide written informed consent.

 The patient is willing and able to comply with the protocol (i.e. self administration of the treatment, and exercise protocol).

 The patient has screening plasma C-reactive protein levels >2 mg/L.

Exclusion criteria:  Subjects will not be eligible if they meet any of the following 15

['Anakinra (weeks 1-2)', 'Anakinra (weeks 3-12)', 'Placebo']

Anakinra (weeks 1-2)
Anakinra (weeks 3-12)
Placebo


Montelukast for Postinfectious Cough

Summary: Cough is a common symptom of respiratory medicine clinic patients, which has complex etiology and wide-ranging. Cough is usually divided into three categories by time: acute cough, subacute cough and chronic cough. Subacute has a 3~8 weeks course of disease. Its main etiology is postinfectious cough, which is mostly secondary to viral infection.Considering its overexpression in postinfectious patient, Cysteinyl leukotriene (CysLTs) plays a role in gathering eosinophils to respiratory. The level of FENO has a significant correlation with inflammatory airway eosinophils. While CysLTs overexpressed in vivo, the level of FENO may increase. Montelukast, as CysLTs-receptor-1 antagonists， plays a role of controlling airway inflammation and decrease airway high activity by suppressing the biological activity of CysLTs. It is effective in theory to therapy sub-acute cough by Montelukast, to short the course and to relieve cough symptoms as soon as possible. The aim is to research whether FENO can be used as a biomarker to optimized treatment regimen of sub-acute cough.
Inclusion criteria: inclusion criteria:

 Cough is the main or only clinical symptom and was persistent for 3-8 weeks

 Chest X-ray reveals no noticeable pathological changes

 18 year old, regardless of gender and ethical background

 Not taking angiotensin-converting enzyme inhibitor

 Patients must join the programme voluntarily and are able to attend examination and follow-up sessions

Exclusion criteria: :

 Patients diagnosed with allergic rhinitis, chronic nasosinusitis or bacterial respiratory tract infections

 Patients diagnosed with severe reportorial disease of other severe systemic disease

 Patients who are allergic to any drugs to be tested

 Patients who are non-cooperative during examination sessions or other steps of the trial

 Patients who are not able to or refuse to sign consent


Inhalation of Liposomal Amphotericin B to Prevent Invasive Aspergillosis

Summary: A Phase II/III randomized double-blind study comparing the safety and the efficacy of a weekly administration of 25 mg nebulized AmBisome with nebulized placebo solution to prevent invasive pulmonary aspergillosis in neutropenic hemato-oncologic patients.
Inclusion criteria: inclusion criteria:

 Male or female hospitalized patients aged > 18 yr

 The patient has a hematologic malignancy or will receive a bone-marrow transplant

 The patient starts with a course of chemotherapy within 4 days or is already neutropenic at admission

 The expected duration of severe neutropenia (PMN<0.5x10*9/L) following study entry is > 10 days

 The patient is receiving oral antibiotic prophylaxis and fluconazole

 Written informed consent has been obtained

Exclusion criteria: :

 The patient shows evidence of a pulmonary fungal infection or a fungal sinusitis at trial entry

 The concomitant use of systemic anti-aspergillus treatment such as itraconazole or any intravenous formulation of amphotericin B at study entry

 Known hypersensitivity to amphotericin B

 Any evidence of pneumonia or pneumonitis at trial entry

 Any impossibility to use a nebulizer properly

 Expected survival < 3 months at entry

 Pregnancy


Utility of Abdominal Ultrasound in the Evaluation of Children With Blunt Trauma

Summary: The major goal of this project is to conduct a randomized controlled trial studying an initial evaluation strategy with abdominal ultrasound versus a strategy without abdominal ultrasound for the evaluation of children with blunt abdominal trauma. The proposal's objectives are to compare the following variables in those that randomize to abdominal ultrasound versus those that do not:~rate of abdominal CT scanning~time to emergency department disposition~the rate of missed/delayed diagnosis of intra-abdominal injury~the costs.
Inclusion criteria: inclusion criteria:

 Blunt torso trauma resulting from a significant mechanism of injury

 Motor vehicle collision: greater than 60 mph, ejection, or rollover

 Automobile versus pedestrian/bicycle: automobile speed > 25 mph

 Falls greater than 20 feet in height

 Crush injury to the torso

 Physical assault involving the abdomen

 Decreased level of consciousness (Glasgow Coma Scale score < 15 or below age-appropriate behavior) in association with blunt torso trauma

 Blunt traumatic event with any of the following (regardless of the mechanism):

 Extremity paralysis

 Multiple long bone fractures (e.g., tibia and humerus fracture)

 History and physical examination suggestive of intra-abdominal injury following blunt torso trauma of any mechanism (including mechanisms of injury of less severity than mentioned above)

Exclusion criteria: :

 No concern for inter-abdominal injury or no planned evaluation for possible IAI

 Prehospital or ED age adjusted Hypotension

 Prehospital or initial ED GCS score ≤ 8

 Presence of an abdominal seat belt sign - continuous area of erythema/contusion completely across the lower abdomen secondary to a lap belt

 Penetrating trauma: stab or gunshot wounds

 Traumatic injury occurring > 24 hours prior to the time of presentation to the ED

 Transfer of the patient to the UCDMC ED from an outside facility with abdominal CT scan, diagnostic peritoneal lavage, or laparotomy previously performed

 Patients with known disease processes resulting in intraperitoneal fluid including liver failure and the presence of ventriculoperitoneal shunts

['Abdominal Ultrasound (FAST examination)']


Neisseria Meningitidis Burden of Disease Study

Summary: This study aims to provide an estimate of the proportion of suspected cases of bacterial meningitis that are due to N. meningitidis and the serogroup responsible in The Philippines and Vietnam.
Inclusion criteria: inclusion criteria:

 Subjects who the investigator believes can and will comply with the requirements of the protocol or subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.

 Written informed consent obtained from the subject/from the parent(s)/LAR of the subject.

 A male or female subject who visits the hospital with suspected bacterial meningitis.

 CSF sample taken as part of routine practice.

Exclusion criteria: :

 Child in care.

['Data collection', 'CSF samples testing']

['Streptococcus Pneumoniae', 'Neisseria Meningitidis', 'Haemophilus Influenzae']

Streptococcus Pneumoniae
Neisseria Meningitidis
Haemophilus Influenzae


Avonex®: Safety, Blood Levels and Effects

Summary: The primary objective was to determine the tolerability of a new inhaled formulation of interferon beta-1a when given as a single dose, when given once per week for 4 weeks, and compared with standard intramuscular (IM) AVONEX® when given as a single dose.~The additional objectives were:~To determine the pharmacokinetic (PK) properties of a new inhaled formulation of interferon beta-1a, using an anti-viral cytopathic effect (CPE) assay for human interferon-beta, when given as a single dose, when given once per week for 4 weeks, and compared with standard IM AVONEX® when given as a single dose.~To determine the pharmacodynamic (PD) properties of a new inhaled formulation of interferon beta-1a, as measured by serum neopterin and 2-microglobulin, when given as a single dose, when given once per week for 4 weeks, and compared with standard IM AVONEX® when given as a single dose.
Inclusion criteria: inclusion criteria:

 Must be between the ages of 18 and 45 years, inclusive.

 Must have a body mass index (BMI) of 19 to 28 kilograms/height (m)2, inclusive, and have a minimum body weight of 50 kilograms (at screening and baseline).

 Must give written informed consent.

Exclusion criteria: :

 History of severe allergic or anaphylactic reactions.

 History of hypersensitivity to acetaminophen (paracetamol) or ibuprofen. Subjects in Part III of the study will also be excluded for history of hypersensitivity to human albumin.

 History of any clinically significant (as determined by the investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease.

 History of asthma, as defined by wheezing, dyspnea, or cough requiring treatment with either inhaled beta-2-agonists, inhaled corticosteroids, inhaled cromolyn sodium, or oral steroids or history of chronic obstructive pulmonary disease (including chronic bronchitis, bronchiectasis, or emphysema).

 Abnormal screening full pulmonary function tests (PFTs) or baseline spirometry (predicted values are those of the European Coal and Steel Community (Quanjer, 1983)) or abnormal screening or baseline oximetry, as defined by any one of the following:

 <80% predicted Forced expiratory volume (FEV1)

 <80% predicted forced vital capacity (FVC)

 <70% FEV1/FVC ratio

 <80% predicted total lung capacity (TLC)

 <80% predicted diffusion capacity, corrected for hemoglobin (DLCOcorr).

 Oxygen saturation of <96% on room air at rest.

 Inability to perform pulmonary function tests in a reproducible manner.

 Inability to use the Pulmonary Delivery System device correctly.

 Abnormal baseline or screening dyspnea scale, defined as a score of equal to or greater than 1 on the modified Medical Research Council (MRC) scale.

 Fever (body temperature >38 degrees C) or symptomatic viral or bacterial infection (including upper respiratory infection) within 1 week prior to the first day of dosing.

 Abnormal baseline or screening blood tests exceeding any of the limits defined below:

 Alanine transaminase (ALT) or aspartate transaminase (AST) or bilirubin > 2x the upper limit of normal (> 2x ULN)

 Total white blood cell count (WBC) < 3700/mm3

 Platelet count < 150,000/mm³

 Hemoglobin < 12 g/dL

 Plasma Creatinine > ULN

 Prothrombin time (PT) or activated thromboplastin time (aPTT) > ULN

 Positive for hepatitis C antibody, hepatitis B surface antigen (HBsAg), or HIV antibody.

 An electrocardiogram (ECG) with a clinically significant abnormality (as determined by the investigator).

 A chest radiograph (CXR) with a clinically significant abnormality (as determined by the investigator).

 History of epilepsy or fits or unexplained blackouts.

 Treatment History

 Previous treatment with any interferon beta or any interferon alpha product.

 Treatment with another investigational drug or approved therapy for investigational use within 3 months prior to the first day of dosing.

 Except for contraceptives, vitamin/mineral supplements, acetaminophen (paracetamol), and/or ibuprofen, treatment with any medication including over-the-counter products within 48 hours prior to the first dose of study drug.

 Miscellaneous

 History of smoking within 6 months prior to the first day of dosing.

 Abnormal screening urine cotinine level (defined as >100 ng/mL when performed by capillary column gas-liquid chromatography).

 History of drug or alcohol abuse (as defined by the investigator) within the 2 years prior to the first day of dosing.

 Blood donation (one unit or more) within 1 month prior to the first day of dosing.

 Vigorous exercise (as determined by the investigator) within 48 hours prior to the first dose of study drug.

 Alcohol use within 24 hours prior to the first dose of study drug.

 Female subjects who are currently pregnant or breast-feeding.

 For female subjects, unless postmenopausal or surgically sterile, unwillingness to practice effective contraception, as defined by the investigator, during the study. The rhythm method is not to be used as the sole method of contraception. Women considering becoming pregnant while on study are to be excluded.

 Positive screening or baseline urine drug screen

 Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's returning for follow-up visits on schedule.

 Current enrollment in any other study.

 Previous participation in this study.


Continuous Glucose Monitoring (CGM) in Subjects With Type 2 Diabetes

Summary: The purpose of this study is to examine the effect CGM (continuous glucose monitoring) has on subjects with type 2 diabetes. It is anticipated that patients using the device will obtain tighter control of their blood sugars resulting in measureable health benefits and improved confidence in their ability to manage their diabetes.
Inclusion criteria: inclusion criteria:

 Have been diagnosed with type 2 diabetes mellitus

 Have an HgbA1c value ≥ 7% and ≤17%.

 Are on basal insulin, with or without oral agents

 Are not on basal bolus insulin therapy.

 Have had no severe hypoglycemic episodes in the 6 months prior to enrollment in the study. Severe hypoglycemia will be defined as any hypoglycemia that is both neurologically impairing and absolutely requires assistance from a third party in the form of carbohydrates, glucagon shots, or attention from a paramedic or other healthcare professional.

 Have no known allergy to medical tape or sensors.

 Are capable of and willing to test their blood glucose (BG) on an average of 4 times per day.

 Are willing to not use Acetaminophen while enrolled in the study.

 Are willing not to undergo a MRI procedure while wearing the CGM sensor.

 Are willing and capable of performing self insertions of the device sensor.

 Women of child bearing potential must be willing to use an approved form of birth control while enrolled in the study.

 Women of child bearing potential must be willing to perform pregnancy tests monthly while enrolled in the study.

 Can understand and speak English fluently.

Exclusion criteria:

 Have been on pump therapy in the 6 months prior to enrollment in the study.

 Are receiving basal- bolus insulin therapy

 Are taking any medication that is not approved to be taken with insulin.

 Are pregnant or have intentions of becoming pregnant during the duration of the study.

 Have any skin condition that would inhibit the proper wearing of the CGM sensor including severe psoriasis, burns, eczema, scarring, excessive tattoos, etc.

 Have a hematocrit ≤30% or ≥55%

 Are currently enrolled in another clinical study (subjects must have ended participation in other studies at least 30 days prior to enrolling in this study.

 Are employed by any company that manufactures or is developing a CGM device.

 Are deemed incapable of participating in the study by the Primary Investigator for any reason.