Be Healthy in Pregnancy (BHIP) With Nutrition and Exercise

Summary: Excess weight gain in pregnancy is a major problem affecting 55-75% of Canadian women who enter pregnancy overweight or obese and about 40% of women who are normal weight. Excess weight gain puts mothers at risk for health problems such as diabetes and developing or sustaining obesity after pregnancy, and puts their babies at risk of being born too large or developing related health problems. Mothers will be randomized to a structured high dairy protein diet and walking program or the usual care by their care provider. The investigators research questions are: Will a structured nutrition and exercise program in pregnancy compared to usual prenatal care increase the chance that mothers will achieve pregnancy weight gain within the current recommendations; improve health measures, in mother and infant at six months post-partum; to evaluate the benefits of a high dairy intake in pregnancy on maintenance of bone status in the mother and bone health outcomes in the child in early life (6 months); and to investigate the interactions between genes associated with bone health and high dairy diet supplementation on bone status in mothers during pregnancy, and bone health in mothers post-delivery and children to 6 months of age. Mothers' weight, physical activity and adherence to the nutrition plan will be assessed until birth and at follow-up with their infants at 6 months after birth. The research team will ensure new information is quickly transferred to programs to assist women to have healthier pregnancies.
Inclusion criteria: inclusion criteria:

 Healthy pregnant females > 18 years of age with singleton pregnancies (either nulliparous or multiparous);

 less than 17 weeks gestation;

 a pre pregnancy BMI < 40 kg/m2 (owing to the fact that severe obesity with BMI> 40 may have limitations with respect to physical activity);

 plans to deliver at a Hamilton or London regional hospital or by home birth and willing to attend research visits at the community site where they were recruited;

 able to tolerate dairy foods;

 approval of primary care provider;

 able to provide signed informed consent.

Exclusion criteria: :

 unable to understand some English;

 type 1 or type 2 diabetes;

 known contraindications to exercise as recommended by the Canadian clinical practice guidelines for pregnancy;

 severe gastrointestinal diseases or conditions;

 any significant heart, kidney, liver or pancreatic diseases;

 pre-existing diabetes;

 currently smoking;

 a depression score 12 or above on the validated Edinburgh depression questionnaire.

['Structured + monitored nutrition and exercise intervention']

['Pregnancy Complications', 'Weight Gain']


A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Trial of the Efficacy and Safety of Bovine Anti-Cryptosporidium Immunoglobulin (BACI) in the Treatment of Cryptosporidium Enteritis in AIDS Patients

Summary: PRIMARY: To assess the effect of bovine anti-Cryptosporidium immunoglobulin (BACI) on the volume of diarrhea due to Cryptosporidium parvum in AIDS patients who have protracted Cryptosporidium enteritis.~SECONDARY: To assess changes in stool consistency and frequency, body weight, and safety in this patient population.
Inclusion criteria: inclusion criteria

 Concurrent Medication:

 Allowed:

 Antidiarrheal compounds (if dose remains stable).

 Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC), or alternative HIV therapy (provided dose was stable for at least 4 weeks prior to study entry).

 Patients must have:

 AIDS.

 Cryptosporidium parvum enteritis.

 Chronic diarrhea.

 Life expectancy of at least 4 weeks.

 Ability to tolerate food by mouth.

 Ability to take the histamine H2-receptor antagonist famotidine (Pepcid).

 Prior Medication:

 Allowed:

 Antidiarrheal compounds (provided dose has remained stable in the 7 days prior to study entry).

 Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC), or alternative HIV therapy (provided dose has remained stable for at least 4 weeks prior to study entry).

Exclusion criteria:

 Co-existing Condition:

 Patients with the following symptoms or conditions are excluded:

 Concurrent unresolved clinical infections with enteric pathogens other than C. parvum (e.g., rotavirus, Salmonella, Shigella, Campylobacter, Giardia, C. difficile toxin, Yersinia, amebiasis, MAI, CMV, Microsporida) as determined by history or routine microbiology screening.

 Other acute infections or concurrent immediately life-threatening medical crisis other than cryptosporidiosis.

 Grossly bloody diarrhea.

 Known allergy to milk or milk products (other than lactose intolerance).

 Prior Medication:

 Excluded:

 Other experimental therapy (e.g., macrolide antibiotics, paromomycin) within 30 days prior to study entry.

['Cryptosporidium Immune Whey Protein Concentrate (Bovine)']


The Place of Imaging and Microbiology in the Diagnosis of Pneumonia in the Elderly

Summary: Diagnosis of pneumonia in the elderly is difficult because of the poor sensitivity and specificity of clinical signs as well as images from chest radiography (RT). New diagnostic tools such as thoracic low-dose computed tomography (CT), which exposes the patient to a weak dose of irradiation, could improve diagnosis. Moreover, low-dose CT could provide additional accuracy in the etiological clarification of pneumonia in elderly people.~As a first step, the investigators aim to perform a 1 year (12 months of inclusion + 3 months of follow-up) prospective study including the Divisions of Internal Medicine, Rehabilitation, Geriatrics and Radiology of the University Hospitals of Geneva. In this study, patients >65 years old with a clinical suspicion of low respiratory tract infection (LRTI) will be included. They will be prescribed antimicrobial therapy. Both chest radiography and low-dose thoracic CT will be performed within the first 72 hours after admission, as will blood tests and a nasopharyngeal swab.~The clinician's diagnosis, both before and after the results of the CT, will be compared at the end of the study to the adjudication committee's diagnostic opinion which will have access to all available clinical, laboratory and chest X-ray data and which will be considered the gold standard. At the end of the study, all the CT images will be blind-reviewed by two experts in radiology. The impact of CT scanning in the diagnosis of pneumonia will be assessed, both for its sensitivity and specificity in this population.~During the first 12 months of the study, all patients will undergo a systematic nasopharyngeal swab at admission and at discharge, from which eluates will be conserved. During the next 12 months, virological and bacteriological polymerase chain reactions (PCR) will be performed, using new diagnostic tools, in order to determine the etiological diagnosis in this population and to evaluate the impact of the new tools in the management of pneumonia for this population.~Analysis of these data will allow clinical, radiological and microbiological correlation.
Inclusion criteria: inclusion criteria:

 Patients above 65 years old

 AND at least one infectious sign: T° >38°C or <35°C; C-reactive protein (CRP) >10 mg/L; leucocytes >10,000/mL with >85% polynuclear neutrophils or left deviation,

 AND at least one respiratory sign: cough; purulent sputum; chest pain; localized crackles; recently appeared dyspnea; oxygen saturation (SpO2) <90%; respiratory frequency >20/min,

 AND who will be prescribed antimicrobial therapy for suspicion of low respiratory tract infection,

 AND who will give consent himself or through his support person.

Exclusion criteria: :

 Diagnosis of pneumonia in the previous six months,

 AND/OR more than 48h of antimicrobial treatment given before hospitalization,

 AND/OR thoracic CT scan performed before hospitalization or inclusion of the patient.

 Each patient will be included only once.


Cognitive Impairment in Parkinson's Disease Categorised in Accordance to Motor Symptoms

Summary: Background: Approximately 40% of patients with Parkinson's disease (PD) have cognitive impairments. There is a lack of consensus as to the extent to which psychiatric symptoms, depression, age at disease onset, disease duration, and medication is related to the type and severity of cognitive impairment. This discrepancy can in part be caused by the lack of distinction between patients with different motor symptoms and disease severity.~Objective: To identify the extent to which psychiatric symptoms, depression, age at disease onset, disease duration, and medication is related to the severity and type of cognitive dysfunction in patients with idiopathic PD categorized according to motor symptoms and disease severity.~Methods: the population of patients with PD in the old county of Aarhus is described on the background of medical records, and stratified in accordance to age, sex and cardinal symptoms. Through proportional allocation a sample of a minimum of 50 patients with PD is drawn from the population. The patients and 30 healthy matched controls will undergo comprehensive neuropsychological assessment including tests of language, memory, executive function, and visuospatial function. Furthermore, all participants will be screened for depression (Geriatric Depression Scale) and psychiatric symptoms (Neuropsychiatric Inventory and Symptom Checklist). The patients will be categorized in accordance with their motor symptoms via cluster analysis for the purpose of analyzing the effect of psychiatric symptoms, depression, and age of disease onset, disease duration, and medication on cognition.
Inclusion criteria: inclusion criteria:

 Idiopathic Parkinson's in accordance to UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria,

 Born and raised in Denmark ,

 >50 years

Exclusion criteria: :

 Cerebrovascular disease,

 Dementia not caused by Parkinson's Disease,

 Metabolism anomaly,

 Abuse of drugs, medication or alcohol,

 History of head injuries,

 Severe psychiatric disorder, excluding depression,

 Resident outside the region of Aarhus h) DBS -


Effects of Inhaled Corticosteroids on Sputum Bacterial Load in COPD

Summary: Exacerbations are important events in the natural history of chronic obstructive pulmonary disease (COPD). Beside the acute (and prolonged) clinical impact, there is evidence that exacerbations negatively affect the natural history of the disease; e.g. lung function decline is accelerated in patients with frequent exacerbations. Bacteria are considered the most relevant cause of exacerbations, but there is evidence that viral infections are equally contributing.~Either alone or in combination with viruses, airway bacterial load in stable COPD correlates with both the frequency of exacerbations and the decline in lung function.~A long-term clinical trial recently showed that the regular treatment with inhaled corticosteroids (ICS) increases the risk of infectious events such as pneumonia, whereas it reduces the frequency of acute COPD exacerbations in COPD.~In a recent study it was found that airway bacterial load increases over time (1 yr follow up) in stable COPD. In this study, virtually all patients (93%) were treated with ICS.~This study is designed to evaluate whether long-term (1 year) ICS treatment increases viral and/or bacterial load in the sputum of COPD patients.
Inclusion criteria: inclusion criteria:

 Sixty stable moderate COPD patients (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2) requiring regular treatment with long-acting bronchodilators, according to international guidelines.

 GOLD stage 2 COPD patients will be enrolled providing they were steroid-free for the last 4 months

Exclusion criteria: :

 Atopy

 Asthma

 Concomitant lung diseases (e.g. lung cancer)

 Acute infections of the respiratory tree in the previous 3 months including COPD exacerbation.

['Chronic Obstructive Pulmonary Disease']


Does Bone Structure Explain the Increased Fracture Risk in Type II Diabetes Patients? A Pilot Study

Summary: For this cross-sectional case control pilot study 30 women, 55-75 years old with type II diabetes will be recruited. Diabetes will be defined as self-report of diabetes previously diagnosed by a physician, use of hypoglycemic medications, or fasting glucose > 126 mg/dl (7.0mM) in accordance with the American Diabetes Association criteria. The diabetic patient population will be divided into 2 groups: patients with status post low energy fractures of the proximal humerus, the proximal femur, the ankle and the foot (n=10) versus diabetic patients with no fractures or low energy trauma fracture history (n=10). An additional group of 10 diabetic postmenopausal women will be recruited and will have magnetic resonance imaging (MRI) of the lower back only. Caucasian, Asian and Hispanic women will be combined since a previous study suggested that BMD is very similar in these 3 population and that ethnic differences are minimal. In addition a population of 10 age-matched, BMI-matched, race-matched healthy women, without osteoporotic fractures will be examined. In all of these volunteers a medical history will be obtained to ensure good health status and rule out chronic diseases that would have an impact on bone metabolism. Patients will undergo MRI, QCT and high-resolution peripheral quantitative computed tomography (HR-pQCT) examinations to determine bone mineral density and bone structure/quality.~The hypothesis of this pilot project is that type II diabetic patients with and without low-energy fractures have a different trabecular bone architecture and composition, which is also different when compared to normal age-matched healthy patients. Architectural differences in these three patient groups may be visualized with high resolution MRI and high-resolution peripheral quantitative computed tomography (HR-pQCT) and will be most pronounced at the calcaneus and the distal tibia. Analyzing structure parameters obtained from high resolution MRI and spectroscopy may improve our understanding of the pathophysiology of diabetic bone disease and the prediction of fracture risk in an elderly diabetic population.
Inclusion criteria: inclusion criteria:

 Postmenopausal female, 55-75 years old

 History of Type II diabetes, as defined by the American Diabetes Association for more than 5 years that is either insulin requiring or treated with oral therapies such as sulfonylureas and metformin

 Body mass index (BMI) of 19-35

 Able to move without walkers and without a history of long periods (>3 months) of inactivity

 Additional inclusion criteria for fracture participants:

 Fractures of the proximal humerus and femur as well as the ankle and foot should have occurred after the onset of diabetes and should have been caused by a low energy trauma such as falling from standing height. All fractures will be verified by radiographs.

Exclusion criteria: :

 Severe neuropathic disease such as neurogenic osteoarthropathies (i.e., Charcot joints) of the foot

 Steroid users or have disease conditions that could play a significant role in the development of osteoporosis such as idiopathic osteoporosis, immobilization, hyperparathyroidism, or hyperthyroidism

 Diseases that may affect bone metabolism: alcoholism, chronic drug use, chronic gastrointestinal disease, renal or hepatic impairment

 Chronic treatment with antacids, estrogen, adrenal or anabolic steroids, anticonvulsants, anticoagulants, or pharmacologic doses of Vitamin A supplements 6 months prior

 Diabetic patients on rosiglitazone or pioglitazone medications

 high energy trauma, e.g., due to motor vehicle accidents

 Pathological fractures of other origin, i.e., tumor, tumor-like lesions as well as focal demineralization visualized on radiographs

 History of fluoride, bisphosphonate, calcitonin or tamoxifen use

 History of unstable cardiovascular disease or uncontrolled hypertension

 MRI contraindications

 Body mass index greater than 35

['magnetic Resonance Imaging', 'Computed Tomography', 'High resolution peripheral quantitative computed tomography']


Ipratropium or Salbutamol Sulphate Alone or Combination Therapy Salbutamol and Ipratropium in Patients With COPD

Summary: Study to compare the effects of nebulised salbutamol or ipratropium alone in patients with COPD with those of combined salbutamol and ipratropium nebuliser solution on arterial oxygen saturation (SaO2) and to characterise patients with COPD (chronic obstructive pulmonary disease) at risk of significant arterial oxygen desaturation following nebulised salbutamol.
Inclusion criteria: inclusion criteria:

 Male and female patients with moderate to severe stable COPD:

 Patients with a diagnosis of chronic bronchitis and/or emphysema

 FEV1 <65% of predicted value without regard to prior treatment

 Forced expiratory ration (FER = FEV1/VC) <70% of predicted value without regard to prior treatment

 Patients must not have had a respiratory infection or an exacerbation of COPD during the four weeks immediately prior to entering the trial

 Patients must not have changed their normal treatment for COPD during the four weeks immediately prior to entering the trial

 Patient aged ≥40 years

 Patients with a smoking history of ≥15 pack-years

 Patients must have given informed consent to participate in the trial

Exclusion criteria: :

 Patients with a diagnosis of asthma, bronchiectasis, cystic fibrosis or bronchiolitis obliterans

 Patients with any of the following:

 untreated angle closure glaucoma

 hypertrophic obstructive cardiomyopathy

 tachyarrhythmia

 recent myocardial infarction (within six months of screening visit)

 severe organic cardiac or vascular disorder

 untreated hyperthyroidism

 diabetes mellitus (after approval of Protocol Amendment 1, the inclusion of well controlled diabetic patients was allowed)

 Patients who are pregnant, or who are planning a pregnancy, and nursing mothers

 Patients known to be hypersensitive to anticholinergic drugs or to β2 agonists

 Patients known to abuse drugs or alcohol

 Patients, who in the opinion of the investigator, are likely not to co-operate with any of the requirements of the trial

 Patients with a PaO2 (arterial carbon dioxide tension) <56 mmHg (7.5 kPa) at rest while breathing air without regard to prior treatment

 Patients with a SaO2 ≤85% at rest while breathing air without regard to prior treatment

 Patients who are taking part in another investigation, and patients who have participated in another clinical trial during the three months immediately preceding entry to this trial

 Patients on home oxygen concentrator therapy

 Patients who have previously participated in the randomised phase of this trial

['Ipratropium bromide 500 µg/salbutamol sulphate 3 mg', 'Ipratropium 500 µg', 'Salbutamol sulphate 3 mg', 'Salbutamol sulphate 6 mg']

['Pulmonary Disease, Chronic Obstructive']


Improving Care for Primary Care Patients With Diabetes and Poor Literacy and Numeracy Skills

Summary: The aim of this research will be to perform a small randomized controlled trial (RCT) of a new diabetes educational intervention that teaches self-management skills that compensate for poor numeracy skills among a sample of primary care patients with type 2 diabetes and low literacy and/or numeracy.
Inclusion criteria: inclusion criteria:

 Clinical diagnosis of Type 2 Diabetes

 most recent A1C >= 7.5%

 Referred to the Diabetes Care Program for diabetes care

 Age 18-85; 5. English Speaking.

Exclusion criteria: :

 Patients with corrected visual Acuity >20/50 using a Rosenbaum Pocket Vision Screener

 Patients with a diagnosis of significant dementia, psychosis, or blindness.

['Literacy/Numeracy oriented educational intervention', 'Control Group']


Is Diverting Ileostomy Necessary in Stapled Ileoanal Pouch?

Summary: Total proctocolectomy with ileal pouch anal anastomosis is the first choice surgical operation for management of ulcerative colitis and familial adenomatous polyposis. The addition of diverting ileostomy may reduce septic complications. In this randomized study the investigators compare two groups of patients with stapled ileoanal pouch one of them had diverting ileostomy and in the other this step is omitted.
Inclusion criteria: inclusion criteria:

 patients having total proctocolectomy with ileal pouch anal anastomosis.

Exclusion criteria: :

 hypoalbuminemia

 prolonged steroid use

 anemia

 anastomosis under tension

 leak with air test

 bleeding

 poor vascular supply of anastomosis

['adding diverting ileostomy', 'omitting diverting ileostomy']

adding diverting ileostomy
omitting diverting ileostomy

['Ulcerative Colitis', 'Familial Adenomatous Polyposis']

Ulcerative Colitis
Familial Adenomatous Polyposis


Study in Infants (6-12 Months) Comparing Two Doses of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Vaccine Versus a Tetanus Toxoid-Conjugated Vaccine Available for the Prevention of Haemophilus Influenzae Type b Infections in China

Summary: This study will evaluate the safety and efficacy of two doses of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 6-12 months of age.
Inclusion criteria: inclusion criteria:

 Infants 6-12 months of age.

Exclusion criteria: :

 Prior Hib vaccine administration.

 History of serious reaction(s) following vaccination.

 Any vaccination within 14 days of study vaccination.

 Known or suspected immune impairment.

 For additional entry criteria please refer to the protocol.

['Haemophilus influenzae type b (Hib) vaccine']

['Haemophilus Influenzae Type b (Hib) Infection']


Exercise Training for Patients With Poor Leg Circulation

Summary: The purposes of this pilot project are to (a) determine changes in calf muscle blood flow and energy supply resulting from calf muscle exercise, and (b) to determine changes in these variables resulting from exercise training (walking and calf muscle exercise). This is a pilot study to prepare for a larger project in the future. Exercise and exercise training should increase blood flow and energy supply to the calf muscles.
Inclusion criteria: inclusion criteria:

 Group I (n=25 PAD patients). This sample will represent the population of veterans with PAD with mild mobility impairment secondary to intermittent claudication in the gastrocsoleus muscles.

 inclusion criteria for PAD Subjects:

 diagnosis of PAD (acute or chronic occlusive arterial disease), with or without diabetes mellitus

 positive Edinburgh Claudication Questionnaire

 Fontaine stage IIa only (mild claudication, walking distance > 200 feet (one-half block)

 ambulatory, without assistive devices

 calf muscle claudication within 10 minutes of treadmill walking and calf muscle exercise

 Group II (n=25 normal control/reference subjects). This reference sample will represent the population of adults without PAD and related problems. They will undergo the PET-exercise testing for perfusion and glucose metabolism measurements, but will not perform the exercise training intervention.

 inclusion criteria for Controls:

 healthy adults, matched by age and sex to PAD subjects

Exclusion criteria: :

['Physical exercise', 'Physical walking']

['Diabetes Mellitus, Type 2', 'Intermittent Claudication']

Diabetes Mellitus
Type 2
Intermittent Claudication


Nephroprotective Effects of Carnitine and (PDE5) Inhibitor Agent Against Contrast Media-induced Nephropathy (CMN)

Summary: CIAKI is a common iatrogenic. Up to date the suggested treatments for CIAKI are partially effective and have not been approved by the Food and Drug Administration yet. The lack of effective nephroprotective drug for CIAKI, emphasizes the need not only for additional new drugs but also for new strategies that might also clarify CIAKI pathophysiology. To the best of our knowledge, the potentially beneficial effect of carnitine and PDE5 inhibitors on CIAKI prevention has not been examined, so far.
Inclusion criteria: inclusion criteria:

 Subjects of 18 years old or older

 CKD stage 3 according to GFR-MDRD equation.

 Two consecutive stable plasma Creatinine levels during the last 2months.

 Elective computed tomography (CT) with a nonionic low-osmolality radiographic contrast agent.

Exclusion criteria: :

 Acute/ chronic renal failure. Acute renal failure is defined as a change in serum creatinine concentration of at least 0.5 mg/dL, or 25% from creatinine measured before the study to that of the day of the procedure.

 Intercurrent illness: e.g. fever… etc.

 Recent exposure to radiographic contrast media in the last month before enrollment.

 Allergy to contrast agents, PDE inhibitors or NAC.

 Hypotension

 Pregnancy and lactation

 Multiple Myeloma

 Intravenous diuretics therapy

 Therapy with any of the nephroprotective drugs 2 weeks before enrollment such as N.A.C. PED5 inhibitor or Carnitine for any reason.

 Severe Congestive Heart Failure, Acute Myocardial Infarction, moderate to severe liver failure (Child-Pugh class B or C).

 Concomitant use of Nitrates, CYP3A inhibitors (e.g Ketonazole, Itraconazole) or Inducers (e.g Rifampin)

 Therapy with potential nephrotoxicity such as NSAID OR COX2 Inhibitors, Aminoglycosides, and Amphotericin B, Cisplatin, etc in the last two weeks before enrollment or within 5 days following the procedure.

 Therapy with Metformin in the last 48 hours before the procedure.

['Acetylcysteine, Phosphodiesterase type 5 inhibitor ,Carnitine']


Freezing of Gait: Clinical, Cognitive, and Imaging Features

Summary: Freezing of gait (FOG) is among the most disabling motor features of Parkinson disease (PD) and is present in other forms of parkinsonism as well. FOG is a brief (usually lasting <30 seconds) episode of absence or a greatly reduced forward movement of the feet despite intention to walk. It typically occurs when patients initiate gait (so-called start hesitation) and when attempting to turn. It is a leading cause of falls and often results in a wheelchair-dependent state. FOG greatly interferes with activities of daily living, causes social isolation and poor quality of life.~FOG is one of the least understood features of PD. It possibly may develop independent of the other motor features of the disease, and be caused by specific pathological changes in the brain. Previous studies on FOG have shown conflicting information and have not lead to clear understanding of the pathophysiology. One key reason for this is that there appears to be multiple subtypes which have rarely been taken into account.~The purpose of this study is to show that different types of FOG exist and to see if there is a connection to cognitive differences or gait patterns.
Inclusion criteria: inclusion criteria for Parkinson disease (PD) subjects with freezing of gait (FOG):

 Diagnosis of PD by United Kingdom Brain bank criteria

 Hoehn & Yahr stage I-IV

 Levodopa treated and responsive

 Able to manage 12 hours off dopaminergic medication

 Age 18-85 years

 Presence of FOG by history and seen by examiner at their clinical office visit or in a video taken at home

 Able sign a consent document and willing to participate in all aspects of the study

 Able to have an MRI scan (no pacemakers or history of claustrophobia)

Exclusion criteria:  for Parkinson disease (PD) subjects with freezing of gait (FOG):

 Dementia that precludes completing study protocol

 Stage V PD - unable to walk independently when off

 History of FOG without ever being seen to have it

 Atypical parkinsonism: Progressive Supranuclear Palsy (PSP), Multiple System Atrophy (MSA), Corticobasal Degeneration (CBD), Vascular Parkinsonism

 Treatment with medications that cause parkinsonism: drug-induced parkinsonism

 Any neurological or orthopedic disorders that interfere with gait

 Treatment with medications that will interfere with NET-PET (norepinephrine transporter-positron emission tomography) ligand binding

 a. Noradrenergic drugs: methylphenidate, atomoxetine, serotonin-norepinephrine reuptake inhibitors (e.g., venlafaxine)

 Absence or loss of levodopa response

 Any contraindications for MRI scan including pacemaker, deep brain stimulator, bladder stimulator, etc.

 inclusion criteria for Parkinson disease (PD) subjects but no freezing of gait (FOG):

 Diagnosis of PD by United Kingdom Brain bank criteria

 Hoehn & Yahr stage I-IV

 Levodopa treated and responsive

 Able to manage 12 hours off dopaminergic medication

 Age 18-85 years, age, gender and duration matched to the PD with FOG recruits

 Absence of FOG by history and by exam, confirmed by caregiver and FOG-Q item 3 score of 0.

 Able sign a consent document and willing to participate in all aspects of the study

 Able to have an MRI scan (no pacemakers or history of claustrophobia)


Study of Tomography of Nephrolithiasis Evaluation

Summary: This is a multi-center, randomized controlled trial of ultrasonography (ultrasound) compared to computed tomography (CT) for the initial emergency room evaluation of patients with suspected renal colic. The investigators will compare several measures of effectiveness including morbidity related to the patient's underlying disease, or complications related to delayed diagnosis, patient status regarding pain/missed days of work, and utilization of health care resources based on one of three study arms: ultrasound in the Emergency Department, ultrasound in Radiology or CT.
Inclusion criteria: inclusion criteria:

 men or women = or >18 but <76 years of age presenting with acute renal colic

 Emergency department physician highly suspects a primary diagnosis of kidney stones (renal colic) or the patient requires imaging to rule out kidney stones.

Exclusion criteria: :

 children < 18 years old

 elderly patients > or = 76 years old

 pregnancy or planning pregnancy

 Morbid obesity (>285 pounds in men, >250 pounds in women)

 patients with an acute abdomen, signs of sepsis, signs of alternate diagnosis (ie appendicitis, abdominal aortic aneurysm, pyelonephritis, kidney stones not suspected).

 history of kidney problems (hemodialysis, kidney transplant, presence of only one kidney)

['Point-of-care Ultrasound', 'Radiology Ultrasound', 'Radiology CT']

Point-of-care Ultrasound
Radiology Ultrasound
Radiology CT


Nebulized Analgesia for Laparoscopic Appendectomy Trial

Summary: The objective of this study is to assess whether the administration of nebulized intra-peritoneal ropivacaine at the onset of surgery, compared with nebulized saline, reduces morphine consumption after laparoscopic appendectomy surgery in children and adolescents.
Inclusion criteria: inclusion criteria:

 Children and adolescents aged 7-18 years old

 ASA Score I (American Society of Anesthesiologists classification) [Appendix 1]: a normal healthy patient.

 ASA Score II (American Society of Anesthesiologists classification): A patient with mild systemic disease

 Patients scheduled for laparoscopic appendectomy surgery

 Uncomplicated appendicitis

 Hemodynamically stable patient

 No evidence of appendiceal perforation based on preoperative clinical and imaging assessment

 Diagnosed to have simple acute appendicitis by intraoperative laparoscopy

 Patients who have provided a written informed assent

 Caregivers who have provided a written informed consent

Exclusion criteria: :

 ASA Score III (American Society of Anesthesiologists classification): A patient with severe systemic disease

 ASA Score IV (American Society of Anesthesiologists classification): A patient with severe systemic disease that is a constant threat to life

 ASA Score V (American Society of Anesthesiologists classification): A moribund patient who is not expected to survive without the operation

 Hemodynamically unstable patient

 Evidence of appendiceal perforation on based on preoperative clinical and imaging assessment

 Perforated or gangrenous appendicitis diagnosed during laparoscopic surgery

 Postoperative admission in an intensive care unit with sedation or ventilatory assistance

 Cognitive impairment or mental retardation

 Progressive degenerative diseases of the CNS

 Seizures or chronic therapy with antiepileptic drugs

 Severe hepatic or renal impairment

 Allergy to one of the specific drugs under study

 Alcohol or drug addiction

 Failure to successfully undergo a laparoscopic appendectomy

 A significant communication problem including language barrier, precluding phone follow up

 Participation in a concomitant research study

 Inability to assure complete follow up

 Failure to acquire informed consent and assent


Utility of Anatometabolic Imaging for Radiation Treatment Planning for Lung Cancer

Summary: This is a research study for patients with inoperable lung cancer called non-small cell lung cancer (NSCLC). Currently, the information from a radiological test, computed tomography (CT) scan of the chest, is used to design the best arrangement of radiation beams which will kill tumor cells and still spare the normal parts of lungs and other normal organs in the chest. The purpose of this study is to explore whether adding information from another radiological test, called positron emission tomography (PET), will improve the accuracy of the radiation beam arrangement designed to treat lung cancer. A PET scan is a way to picture the biochemistry of tissues and organs: of how tissues in the body take up glucose, a normal nutrient of the body. The researchers will attempt to create radiation treatment plans from PET images alone and compare differences between hypothetical plans and standard-of-care CT-based radiation treatment plans. Because there is honest uncertainty about the contribution of PET to radiation treatment planning, it is possible that there will be no difference between a CT-based treatment plan and one resulting from PET information. It is also possible that the addition of PET may result in a radiation beam arrangement that may better control lung cancer. The addition of PET may also result in treating less normal tissues, which may lower the risk of radiation side effects. This study will provide the preliminary data necessary to design a larger clinical trial that may define the role of PET in radiation treatment planning.
Inclusion criteria: inclusion criteria:

 Histologically confirmed locally advanced NSCLC (squamous, large cell undifferentiated or adenocarcinoma).

 Disease limited to the thorax, adjacent mediastinum and neurovascular structures, and supraclavicular or scalene lymph node area, as defined by the AJCC Staging System. This includes patients with Stage IIIA and IIIB disease.

 Performance status of 0-2 by Southwest Oncology Group criteria.

 Medically inoperable patients (Stage I or II)

 Locoregional recurrent tumor following surgery will be eligible provided they meet other eligibility criteria.
Exclusion criteria:

['PET scan use in radiotherapy planning']


The Efficacy of Breathing Exercise With BreatheMAX Device on Airway Secretion Clearance and Lung Function

Summary: The efficacy of breathing exercise with oscillated inspiratory loading and oscillated positive expiratory pressure for airway secretion clearance and lung function in intubated patients, both with and without mechanical ventilation dependence
Inclusion criteria: inclusion criteria:

 Intubated patients (with and without mechanical ventilator support) with secretion 1.5 ml/h, If the patients are breathing with mechanical ventilation, the PEEP level must be less than 6 centimeter of water and one of following

 Clinical and radiologic diagnosis of pulmonary infection

 Acute or chronic airway inflammation disease such as pneumonia, bronchiectasis, chronic obstructive pulmonary disease or chronic bronchitis and at least one sign of secretion accumulation in bronchial such as medium-coarse crackle, wheezing, persistent rhonchi and decrease breath sound

 Stable of cardiopulmonary function at least 2 days before the study and the patients don't receive the vasopressors drug within 5 days before collects the data

 Stable of hydration status or positive fluid balance at least 2 days before collects the data

 Ability to breathe or tolerate spontaneously breathing trial with T-piece at least 2 minutes with fraction of inspired oxygen less than 0.4 and without developing hypoxemia

 Good conscious and well cooperation

Exclusion criteria: :

 Pneumothorax (nontreated)

 Massive hemoptysis

 Acute myocardial infarction (with angina chest pain)

 High intracranial pressure (>20 mm Hg)

 Major arrhythmia

['BreatheMAX (OPEP)', 'BreatheMAX (OIS and OPEP)', 'BreatheMAX (unload and non-oscillated)']

BreatheMAX (OPEP)
BreatheMAX (OIS and OPEP)
BreatheMAX (unload and non-oscillated)


Use of Azithromycin as Immunomodulatory Therapy in Grave&Apos;s Orbitopathy

Summary: The purpose of this study is to examine the effects of Azithromycin (a macrolide class antibiotic), given three times weekly, for patients with active moderate-severe, non sight-threatening, Graves Orbitopathy.~Indices for follow-up will include:~Clinical activity score~Anti-TSH receptor antibody levels~Thickening of extraocular muscles per ultrasound~Quality of life score for Graves Orbitopathy patients
Inclusion criteria: inclusion criteria:

 Clinical diagnosis of Graves Orbitopathy

 Clinical activity score higher than 2

 Must be able to swallow tablets

Exclusion criteria: :

 sight-threatening Graves Orbitopathy

 Diplopia in primary gaze

 Macrolide allergy or intolerance


Weight Management Intervention for Obese Women and the Live Birth Outcome of in Vitro Fertilization (IVF)

Summary: The primary aim of the study is to evaluate if weight management intervention for obese women (BMI≥30<35 kg/m2) prior to IVF improves the outcome assessed as live birth per participating woman, as compared to women where no intervention was made.
Inclusion criteria: inclusion criteria

 Indication for IVF/ICSI for the couple

 Woman's age >18< 38 years at randomization

 First, second or third IVF/ICSI treatment

 BMI > or = 30.0 <35.0 kg/m2

 Willing to participate and to sign informed consent

Exclusion criteria: :

 Diabetes mellitus treated with insulin

 Oocyte or sperm donation planned

 Preimplantation genetic diagnosis (PGD) treatment planned

 Azoospermia known at randomization

 Patient not having adequate knowledge of Swedish (to understand patient information and questionnaires)

 QEWP-R questionnaire indicating binge eating disorder for the woman

 Previous participation in the study


Racial Variation in ACE--Genetic and Physiologic Bases

Summary: To determine whether differences in the activity of the renin-angiotensin and bradykinin systems are involved in the pathogenesis of blood pressure variation in African Americans.
Inclusion criteria: No eligibility criteria
Exclusion criteria:

['Cardiovascular Diseases', 'Heart Diseases', 'Hypertension']

Cardiovascular Diseases
Heart Diseases
Hypertension


The Effect of Leucine on Body Composition and Muscle Characteristics in Elderly, Type 2 Diabetes Patients

Summary: The purpose of this study is to determine whether long term leucine supplementation has a positive effect on body composition and muscle characteristics in elderly, type 2 diabetes patients.
Inclusion criteria: inclusion criteria:

 Clinical diagnosis of type 2 diabetes

Exclusion criteria: :

 Impaired renal or liver function

 Cardiac disease

 Subjects with metal implants

 Hypertension

 Diabetes complications

 Exogenous insulin therapy


Lamictal As Add on Treatment in Mixed States of Bipolar Disorder

Summary: To evaluate the efficacy and safety of LAM+existing regimen of mood stabilizer in the acute treatment of patients in a mixed state of bipolar disorder.~To evaluate the efficacy and of a combination of LAM+existing regimen of mood stabilizers in the maintenance treatment of patients with mixed state of bipolar disorder
Inclusion criteria: inclusion criteria:

 In order to be included in the study patient must meet criteria A, C, D, E, F, G plus any 1 of the 3 criteria listed in section B.

 A. Patients meeting DSM-IV diagnosis of bipolar disorder, I or II

 B.

 Patients meeting DSM-IV diagnostic criteria for a manic/hypomanic episode with the simultaneous presence of (or rapid alteration within minutes) of at least three DSM-IV depressive symptoms excluding psychomotor agitation or

 Patients meeting DSM-IV symptomatic criteria for a hypomanic/manic episode for a period of 2 days or longer, with the simultaneous presence of (or rapid alteration within minutes) of at least three DSM-IV depressive symptoms excluding psychomotor agitation or

 Patients meeting DSM-IV criteria for a depressive episode associated with at least three DSM-IV manic/hypomanic symptoms

 C.MADRS of ≥14

 D.YMRS of ≥ 14

 E. Age 13years to 75 years

 F. Male or female

 G. Outpatient

Exclusion criteria: :

 illness precluding the use of LAM

 Alcohol/drug dependence in the past one month

 patients with a history of a rash on LAM

 CNS neoplasms, demyelinating diseases, degenerative neurological condition or active CNS infection

 history of seizure, known EEG with frank paroxysmal activity, known CT of brain showing gross structural abnormalities, cerebral vascular disease by history or structural brain damage from trauma

 patients currently taking LAM


Immunologic Response to Pneumococcal Polysaccharide Vaccine in Splenic Injury Patients

Summary: Persons without a spleen are susceptible to potentially lethal infections from certain bacteria, with pneumococcus being the most prevalent. Vaccines are provided to help protect against these infections, though they do not so with certainty. Trauma patients who sustain an injury to their spleen currently have three treatment options available for the treating surgeon - nonoperative management, embolization, or removal of the spleen. The purpose of this study is to investigate the antibody response to pneumococcal vaccine in patients undergoing these modes of therapy.
Inclusion criteria: inclusion criteria:

 Adult trauma patients (aged 18 to 65 years old) sustaining a splenic injury.

Exclusion criteria: :

 Ages less than 18 and greater than 65

 Initial planned nonoperative management patient who subsequently undergoes embolization or splenectomy will be withdrawn from the study.


Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine For The Treatment Of Uncomplicated, Symptomatic Falciparum Malaria In Southeast Asia

Summary: The primary objective is to confirm the hypothesis that azithromycin (optimal dose once daily for three days) plus chloroquine is non-inferior to sulfadoxine-pyrimethamine plus chloroquine for the treatment of uncomplicated, symptomatic malaria due to P. falciparum.
Inclusion criteria: inclusion criteria:

 Females and males >=18 years of age with uncomplicated, symptomatic malaria as indicated by the presence of both of the following: a.) Blood smears positive for Plasmodium falciparum asexual parasitemia between 1000 -100,000 parasites/mL b.) Fever or history of fever (>= 38.5 C/101.2 F rectal or tympanic; >= 37.5 C/99.5 F axillary or >= 38 C/100.4 F oral) within the prior 24 hours

 Serum glucose >= 60 mg/dL (by fingerstick or peripheral blood collection)

 Positive rapid diagnostic test (Binax NOW ICT) for P. falciparum

 Women of childbearing potential must have a negative urine gonadotropin prior to entry into the study and must agree to use adequate contraception during the entire study

Exclusion criteria: :

 Severe or complicated malaria including subjects with any of the following: a.) Impaired consciousness, seizures or abnormal neurologic exam b.) Jaundice c.) Respiratory distress d.) Persistent vomiting e.) Hematuria, as reported by the patient f.) Parasite density > 100,000 parasites/mL g.) Presence of non-falciparum species on microscopy

 Pregnant or breast-feeding women

 History of allergy to or hypersensitivity to azithromycin or any macrolide, sulfonamides, pyrimethamine, or chloroquine

 Known history of blood dyscrasias (e.g., megaloblastic anemia, agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia)

 History of epilepsy or psoriasis

 History of treatment with any antimalarial drug (chloroquine, quinine, mefloquine, Malarone, SP, artemisinin compounds) or antibacterial with known antimalarial activity (macrolides, doxycycline, clindamycin) within 2 weeks prior to enrollment into the study

 Known or suspected cardiovascular, hepatic or renal abnormality that in the opinion of the Investigator would place the subject at increased risk to participate in the study. The following findings are specific exclusions: a.) serum creatinine > 2.0 x ULN b.) ALT and/or AST > 3 x ULN

 Inability to swallow oral medication in tablet form

 Treatment with other investigational drugs within 30 Days prior to enrollment into the study

 Alcohol and/or any other drug abuse

 Requirement to use medication during the study that might interfere with the evaluation of the study drug (nelfinavir, digoxin, ergot alkaloids, terfenadine, cyclosporine, hexobarbital and phenytoin)

 Specific systemic diseases or other medical conditions that would interfere with the evaluation of the therapeutic response or safety of the study drug

 Inability to comprehend and/or unwillingness follow the study protocol

 Intentions to leave the vicinity of the trial site in the next 42 days

 Prior participation in this study


The Prognosis of Early Pregnancy With Post Coital Bleeding

Summary: This is a prospective study, where the investigators will monitor pregnant women at 4-23 weeks of pregnancy coming to the Women- E.R. at Meir Hospital due to spontaneous -or after intercourse- bleeding or bleeding secretions. The women will fill out questionnaires regarding past illness, vaginal bleeding, and gynecologic history. Then they will undergo full examination including ultrasound. After discharge, the investigators will recommend to all the women who came due to bleeding or bleeding secretions to avoid intercourse for two weeks after the bleeding stops. Afterwards they will be monitored until their delivery date (filling questionnaires a month after coming to the E.R. and at the end of the pregnancy). After they give birth the investigators will assess the rate of pregnancy, obstetric and embryonic complications in each of the study groups.
Inclusion criteria: inclusion criteria:

 women (age 18-40) with early pregnancy (4-23 weeks) with singleton or twins pregnancy that address to the Women E.R. due to vaginal bleeding.

Exclusion criteria: :

 age >40 or <18

 women with history of more then 3 abortions.

 women with history of more then 2 pre term labor

 ectopic pregnancy

 placental previa

 women who takes anticoagulation therapy

 women with known pathology at cervix.

 women with known uterus defect. pregnancies with chromosomal defects or birth defects that was discovered at the screening tests.

['Vaginal Bleeding During Pregnancy', 'Postcoital Bleeding']

Vaginal Bleeding During Pregnancy
Postcoital Bleeding


Hyperbaric Chamber for Central Retinal Vein Occlusion (CRVO) Patients

Summary: Hyperbaric chamber treatment assists in increasing the amount of oxygen in the plasma and in the tissues and has been proven to be beneficial in treating different ischemic wounds, and acute retinal artery occlusion (ARAO) but its effect hasn't been tested in CRVO patients yet.
Inclusion criteria: inclusion criteria:

 Patients age 18-80 years with a documented CRVO who treated by Avastin for more than 12 months.

 Patients who signed an informed consent form

Exclusion criteria: :

 Patients with Carotid stenosis of more than 70%

 Anemia of < 10mg/Dl

 Patients with chest X ray pathology which cannot be admitted to hyperbaric chamber treatment.

 Patients with claustrophobia or that cannot decompress properly.

 Patients with any malignant disease

 Patients with inability to sign informed consent


Pregabalin in the Treatment of Essential Tremor

Summary: Pregabalin is approved for the treatment of nerve pain as well as an additional therapy in the treatment of seizures. In December 2004, Pfizer gained Food and Drug Administration (FDA) approval for use of pregabalin in nerve pain associated with diabetes and shingles; making it the first FDA-approved treatment for both of these nerve pain states.~Tremor is uncontrolled trembling in part of the body. Essential tremor (ET) is associated with purposeful movement(e.g., holding a glass to drink, shaving, writing and buttoning a shirt). It occurs most often in the hands and head and also may affect the arms, voice box (larynx), trunk, and legs. ET is caused by abnormalities in areas of the brain that control movement. It usually does not result in serious complications.~ET affects approximately 5 million people in the United States. Incidence is highest in people over the age of 60.~ET usually develops gradually during middle age or later in life. Symptoms may remain mild or become more severe over time. Stress, fatigue, anxiety, and hot or cold weather can worsen the disorder. Severe tremor may cause difficulty doing activities of daily living, such as:~Brushing hair and teeth~Holding a glass without spilling~Performing self-care (e.g., getting dressed, shaving, putting on makeup)~Using eating utensils~Writing and drawing~The purpose of this pilot/feasibility study is to examine the tolerability and efficacy of Pregabalin in patients with ET.~In other words, can patients diagnosed with ET tolerate high dose of pregabalin? Will the pregabalin be considered as an efficient medicine in the treatment of ET?
Inclusion criteria: inclusion criteria:

 Subjects must be between the ages of 18 and 80 inclusive.

 Each subject must have current manifestations of ET symptoms based on the Tremor Investigational Group (TRIG) criteria for definite or probable ET: - Moderate or severe tremor in head or arms for at least 3 years duration. - No present causes of enhanced physiologic tremor. - No recent exposure to tremorogenic drugs or drug withdrawal states. - No direct or indirect trauma to the nervous system within 3 months preceding the onset of tremor. - No historic or clinical evidence of psychogenic tremor origin.

 Subjects with a history of seizures are eligible.

 Subjects must be in generally good health as evidenced by previous medical history and clinical examination.

 Patients will be allowed to take Beta-blockers but will not be allowed to take any other medication for tremor (primidone, topiramate, benzodiazepines, etc.) An evening dose of a benzodiazepine to improve sleep is acceptable. They must have been on a stable dose of any existing beta-blocker for 4 weeks prior to entry into the study and will not be allowed to change the dose of that medication throughout the controlled portion of the study. Any medication discontinued during screening in order to comply with these criteria must be stopped for 5 half-lives prior to study initiation.

 Subjects must be accessible by telephone.

 If the subject is a female of childbearing age, she must have had a hysterectomy, tubal ligation, otherwise be incapable of pregnancy, or have practiced one of the following methods of contraception for at least one month prior to study entry (or a negative urine pregnancy test within one week of study entry): - Hormonal contraceptives - Spermicide and barrier - Intrauterine device - Partner sterility

 Prior to participation in this study, each subject must sign an informed consent.

Exclusion criteria: :

 Patients do not meet TRIG criteria for probable ET.

 Subjects who are not able to abstain from alcohol for 24 hours prior to each evaluation.

 Patients who can not maintain an identical dose of any medicine that may affect tremor during their entire study involvement.

 Subjects who have exhibited any psychotic symptomatology.

 Subjects who have known renal deficiencies.

 Subjects who have been intolerant of pregabalin in the past

 Prior surgical treatment for tremor.

 Patients currently taking more than a single drug for ET.

 Patients taking anti-seizure medications.

 Breast feeding or pregnant females.


Daptomycin in Pediatric Patients With Bacterial Meningitis

Summary: 5 Children > 3months and < 16 years with Gram-positive meningitis will receive a single dose of daptomycin 24 hours after the first dose of ceftriaxone. 4-8 hours after daptomycin administration a second lumbar puncture is performed to determine the peak concentration of daptomycin in the cerebrospinal fluid. In parallel peak and trough level of daptomycin will be measured in the plasma. The investigators anticipate that daptomycin penetrates into the cerebrospinal fluid in bactericidal concentrations
Inclusion criteria: inclusion criteria:

 Age > 3 months and < 16 years

 Bacterial meningitis

 Written parental (or appropriate legal representative) informed consent prior to study inclusion

Exclusion criteria:

 Gram-negative bacteria in the CSF

 Creatinine clearance < 80ml/min/1.73m2

 Creatinine phosphokinase level > 2x upper age related norm

 Known allergy or hypersensitivity to daptomycin

 Known clinical significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, endocrine, hematologic, autoimmune disease, or primary immunodeficiency

 Height and weight below 3rd or above 95th percentile

 History of, or current muscular disease

 Underlying neurological disease with disruption of blood brain barrier

 Epilepsy

 Muscular weakness, history of peripheral neuropathy, or Guillain-Barré syndrome


Hepcidine and Iron Deficiency in Critically Ill Patients

Summary: Anaemia is very frequent among critically ill patients, concerning more than 60 % of them at admission and more than 80% at intensive care unit discharge. Iron deficiency is also frequent at admission, with prevalence around 25 to 40%. During their stay in Intensive Care Unit, critically ill patients are exposed to repeated blood samples and to other blood losses (daily blood loss has been evaluated to be as high as 128 ml/day in median), this leads to direct iron loss. Prevalence of iron deficiency may thus be very important at Intensive Care Unit discharge. However, iron deficiency diagnosis is complicated in these patients, since inflammation induces an increase in plasma ferritin levels and a decrease in transferrin saturation, the two usual markers of iron deficiency. As a consequence, iron deficiency is usely under-diagnosed in these patients. Treatment of iron deficiency may be indicated to correct anaemia but also to improve patients fatigue and muscular weakness. The characterization of iron metabolism regulation by the hormone hepcidin opened new ways for the understanding and the follow-up of these complex clinical situations (combining inflammation and iron deficiency). Indeed, iron deficiency is associated with a decrease in hepcidin synthesis, while iron overload induces hepcidin synthesis. Furthermore, low hepcidin levels are required to mobilize iron from stores. Hepcidin has thus be proposed as a marker of iron deficiency in critically ill patients. To date, standard immunological methods of hepcidin quantitation are only proposed in the reasearch setting and could not be proposed in the clinical setting because it is too expensive. New approaches for hepcidin quantification, based on mass spectrometry are proposed and may be routinely implemented. We make the hypothesis that treating iron deficiency in critically ill anemic patients, diagnosed by hepcidin quantification, may improve the post-Intensive Care Unit rehabilitation, and may thus reduce post-Intensive Care Unit cost linked to hospital stay and anaemia treatment.~The aim of this study is to evaluate the medical economic interest of a new diagnostic method for iron deficiency, based on a quantitative dosage of hepcidin by mass spectrometry in critically ill anaemic patients.
Inclusion criteria: inclusion criteria:

 Hospitalized man/woman in reanimation unit for at least 5 days.

 Age ≥ 18 years old.

 Patient having an anaemia such as defined by the WHO (World Health Organization) (for man: Hemoglobin < 13 g/dl, for woman: Hemoglobin < 12 g/dl).

 Signed inform consent by the patient or a close person.

 Subject affiliated to a national health insurance

Exclusion criteria: :

 Known iron metabolism pathology (such as primitive or secondary hemochromatosis, …).

 Chronic anaemia (Hemoglobin ≤ 10 g/dl for more than 3 months).

 Current chemotherapy.

 Patient having an organ transplant

 Expected survival < 28 days post Intensive Care Unit discharge.

 Pregnancy

 Patient deprived of freedom, by judicial or administrative order.

 Major protected by the law.

 Contra-indication to the injectable iron treatment (allergy to ferric carboxymaltose, infection derivates (bacteriamy < 48 hours) untreated).

 Non speaking French patient, or patient unable to answer a questionnaire because of any neurologic disorder (stroke, brain trauma….).

['hepcidin', 'ferritin and transferrin saturation']

hepcidin
ferritin and transferrin saturation

['Anemia', 'Critical Illness', 'Hospitalized for 5 Days or More']

Anemia
Critical Illness
Hospitalized for 5 Days or More


Etiology of Diarrhea in Guinea-Bissau and in Finland

Summary: Diarrhoea is the leading cause of death in the world with 2.2 million deaths every year. The majority of deaths are among children in developing countries, but the travellers encounter the disease as well. The studies on the aetiology have suffered from serious methodological deficiencies and the results are even controversial. At the same time, the current diagnostic methods are inadequate. The investigators have recently developed novel multiplex RT-PCR methods to cover the majority of diarrhoeal pathogens. The present study is a collaboration between Finland and Sweden/Guinea-Bissau. The aim is to characterize the causative agents of diarrhoea (a) in Finnish volunteers before and after a travel to tropical areas and, (b) in inhabitants of endemic areas in Guinea-Bissau. For these purposes stool samples will be collected from volunteers of different age groups and from healthy volunteers as well as those with diarrhea both in Guinea-Bissau and in Finland. In addition to pathogens, other intestinal microbes and antimicrobial resistance will be investigated
Inclusion criteria: inclusion criteria:

 Accepting to participate and willing to deliver 2 stool samples.

 With diarrhea: the first 10 children and 10 adults presenting each month at the health facility Without diarrhea: In Bissau matched controls drawn from the registration system at Bandim Health Project. In Finland controls selected at the health facilities participating.

Exclusion criteria: :

 Not willing or able to deliver the stool samples


Ziprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder(GAD)

Summary: The specific aim of this study is to evaluate the efficacy, tolerability, and safety of ziprasidone monotherapy in comparison to placebo in the treatment of ambulatory bipolar disorder with co-morbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety.
Inclusion criteria: inclusion criteria:

 Subjects must at least age of 18 years of age and not older than 65.

 Subjects must have lifetime bipolar I, II, or NOS disorder as defined by DSM-IV TR criteria (26).

 Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV criteria (except clause does not occur exclusively during a mood disorder of Criterion F for GAD).

 Subjects' bipolar symptoms must be no more than moderate in severity, defined as a CGI-BP< 4 (27).

 Subjects' anxiety symptoms must be at least moderate in severity, defined as a CGI-S > 4 (28).

 Subjects must not be receiving regular mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for at least one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for at least four weeks prior to baseline.

 Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained.

 If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, barrier methods, intrauterine device) for at least one month prior to study entry and throughout the study.

Exclusion criteria: :

 Subjects who do not have lifetime bipolar disorder by DSM-IV-TR criteria (26).

 Subjects who do not have lifetime panic disorder or generalized anxiety disorder by DSM-IV-TR criteria (26).

 Subjects who are receiving treatment with an anti-manic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication.

 Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP > 5) (27).

 Subjects whose anxiety symptoms are presently less than moderately severe (CGI-S < 3) (28).

 Subjects with clinically significant suicidal or homicidal ideation.

 Subjects with a current DSM-IV TR Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV TR diagnosis of a substance dependence disorder within the past six months; a lifetime DSM-IV TR psychotic disorder (e.g., schizophrenia or schizoaffective disorder).

 Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurological, or hematological disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo- or hyperthyroidism unless stabilized on thyroid replacement > 3 months.

 Subjects with a clinically significant abnormality in their pre-study physical exam, vital signs, EKG, or laboratory tests.

 Subjects who are allergic to or who have demonstrated hypersensitivity or intolerance to ziprasidone.

 Women who are pregnant or nursing.

 Subjects who have received an experimental drug or used an experimental device within 30 days.

 Subjects who have a history of neuroleptic malignant syndrome.

 A patient with diabetes mellitus (DM) fulfilling one of the following criteria:

 Unstable DM defined as enrollment glycosylated hemoglobin (HbAlc) >8.5%

 Admitted to hospital for treatment of DM or DM related illness within the past 12 weeks

 Not under physician care for DM

 Physician responsible for patient's DM care has not indicated that the patient's DM is controlled

 Physician responsible for patient's DM care has not approved the patient's participation in the study

 Has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the 4 weeks before randomization. For thiazolidinediones(glitazones)this period should not be less than 8 weeks before randomization.

 Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks

 Note: If a patient with DM meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study

['Bipolar Disorder', 'Panic Disorder', 'Generalized Anxiety Disorder']

Bipolar Disorder
Panic Disorder
Generalized Anxiety Disorder


Cyclosporine A to Treat Hypertrophic Cardiomyopathy (HCM)

Summary: This study will examine the effectiveness of the drug cyclosporine in treating hypertrophic cardiomyopathy (HCM), a condition in which the heart muscle thickens. The thickened muscle can impair the heart's pumping action or decrease its blood supply, or both. Various symptoms, such as chest pain, shortness of breath, fatigue, and palpitations, may result. In animal studies, cyclosporine prevented heart muscle from thickening in mice that had been engineered to develop thick hearts.~Patients with HCM 18 to 75 years old are screened for this study under protocol 98-H-0102 and this protocol. Screening tests include blood tests, echocardiogram to measure heart thickness, Holter monitor to record heartbeats, treadmill exercise test, and various imaging tests including a thallium scan, radionuclide angiography, magnetic resonance imaging (MRI), and cardiac catheterization to examine heart function and blood supply.~Patients admitted to the study will be randomly assigned to take either cyclosporine tablets or a placebo (a look-alike tablet with no active ingredient) twice a day for 6 months. During a brief hospital stay at the start of the study, blood samples will be taken to measure cyclosporine levels. After discharge, heart rate and blood pressure will be checked and blood tests done during follow-up visits once a week for 2 weeks and then every two weeks until the end of the 6-month treatment period. At that time, patients will be hospitalized a second time for repeat tests to determine the effects of the drug on the heart condition. They include thallium scan, radionuclide angiogram, MRI, treadmill exercise test, cardiac catheterization, and echocardiogram. An echocardiogram and MRI will be repeated 1 year after the start of the study to evaluate long term effects of the drug, if any.
Inclusion criteria: Patients of either gender, aged 18-75 years, with HCM caused by sarcomeric gene mutations determined by existing protocols.

 LV wall thickness of greater than or equal to 20 mm measured in any LV segment by MRI.

 Severe symptoms refractory to medical treatment (New York Heart Association functional class III or IV).

 No LV outflow tract obstruction at rest greater than 30 mm Hg as determined by cardiac catheterization.

 No coronary artery disease (greater than 50% arterial luminal narrowing of a major epicardial vessel).

 No chronic atrial fibrillation.

 No bleeding disorder (PTT greater than 35 sec, pro time greater than 14 sec, platelet count less than 154 k/mm(3).

 No anemia (Hb less than 12.7 g/dl in males and less than 11.0 g/dl in females).

 No renal impairment (serum creatinine greater than 1.3 mg/dl).

 No hepatitis B or C; nor unexplained abnormal LFTs.

 No inability to estimate LV wall thickness.

 No positive urine pregnancy test.

 No pregnant or lactating female patients.

 No concurrent use of immunosuppressives or steroids.

 No diabetes mellitus.

 No history of malignancy other than skin tumors (squamous and basal cell) in the last 5 years.

 No condition that excludes the patient from undergoing an MRI test.
Exclusion criteria:

['Cardiomyopathy, Hypertrophic', 'Heart Hypertrophy']

Cardiomyopathy
Hypertrophic
Heart Hypertrophy


A Preemptive Epidural Ropivacaine for Postoperative Pain Relief in Degenerative Lumbar Spine Surgery

Summary: This prospective randomized study aims to evaluate the effectiveness of epidural injection of ropivacaine on the relief of pain in patients undergoing laminectomy.~Total 60 patients will be randomized into one of two groups (groupC or groupI) based on Excel number generation.~Patients in group C will receive no medication intraoperatively, and patients in group I will receive epidural injection of 0.1% ropivacaine 10ml before skin incision.~Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4,12,24,48 hour postoperatively.
Inclusion criteria: inclusion criteria:

 laminectomy

Exclusion criteria: :

 r/o infection

 reoperation

 mental change

 allergy to local anesthetics

['Placebo (one of medication)', 'Ropivacaine (epidural injection)']

Placebo (one of medication)
Ropivacaine (epidural injection)


Safety and Efficacy of Oral Fampridine-Sustained Release (SR) for the Treatment of Spasticity Resulting From Spinal Cord Injury

Summary: Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with spinal cord injury, some fibers may be destroyed at the site of injury, while others remain connected but do not work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal cord injury may have spasticity which is muscle spasms or muscle stiffness that makes movement difficult. Fampridine-SR is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as bladder control, bowel function and sexual function. The study will also examine the possible risks of taking Fampridine-SR.
Inclusion criteria: inclusion criteria:

 Incomplete traumatic Spinal Cord Injury (at least 18 months prior and stable for 6 months)

 Moderate to severe lower-limb spasticity

 Able to give informed consent and willing to comply with protocol

Exclusion criteria: :

 Pregnancy

 History of seizures

 Existing or history of frequent Urinary Tract Infections

 History of drug or alcohol abuse

 Allergy to pyridine-containing substances

 Received a botox injection 4 months prior to study

 Received an investigational drug within 30 days

 Previously treated with 4-aminopyridine (4-AP)

 Not on stable medication dosing in 3 weeks prior to study

 Abnormal ECG or laboratory value at screening

['Spinal Cord Injury', 'Muscle Spasticity']


Sleep and Immunity in Rheumatoid Arthritis : Remicade Substudy

Summary: More than half of rheumatoid arthritis (RA) patients complain of sleep disturbance and this cardinal complaint is associated with fatigue, pain, and depressed mood in patient with chronic inflammatory disorder. Despite the frequency of this complaint, there is limited efforts to evaluate sleep or the abnormal increases in the expression of pro-inflammatory cytokines play a key role in the progression of RA, we hypothesize that the cytokine network is one physiological system that is associated with sleep disturbances in RA patients. Pro-inflammatory cytokines signal the central nervous system and are associated with increased symptoms of pain, fatigue, and depressed mood in rheumatic patients. The specific aims of the study are to examine the contribution of cytokines on sleep by administering a TNF antagonist vs. placebo to probe the action of pro-inflammatory cytokines on sleep in RA Patients. Examination of sleep and its consequences for pro-inflammatory cytokine activity within the framework of an observational and experimental research design will have implications for understanding the psycho-biological mechanisms that link sleep and the clinical manifestations of RA. Results from this study will guide the developments of interventions that target disordered sleep with potential effects on disability in RA.
Inclusion criteria: inclusion criteria:

 Rheumatoid arthritis patients will meet American College of Rheumatology revised criteria (Arnett, Edworthy et al. 1988). This requires at least four of the following seven criteria: 1) morning joint stiffness; 2) arthritis in 3 or more joint areas; 3) arthritis of hand joints; 4) symmetric arthritis; 5) rheumatoid nodules; 6) presence of serum rheumatoid factor and 7) changes on posteroanterior hand and wrist radiographs. In addition, criteria 1-4 must be present for at least four weeks. Subjects must be between 18 and 85 years of age.

 If rheumatoid arthritis patients are receiving treatment with traditional disease modifying antirheumatic drugs (DMARD), such as methotrexate, sulfasalazine or hydroxychloroquine, they must be on a stable regime for one month before study and stable throughout study.

 If rheumatoid arthritis patients have received treatment with a TNF antagonist or other biologic medication, they must be drug free for greater than 3 months.

Exclusion criteria: :

 Steroids - Individuals currently taking greater than an equivalent of 10 mg of prednisone will be excluded given the potent anti-inflammatory effects of such medications.

 Opioids - Individuals using multiple daily dosage schedule of opioid agents such as oxycodone (Percocet), hydrocodone (Vicodin), morphine, Dilaudid will be excluded.

 Co-morbid medical disorders - the presence of active unstable and uncontrolled co-morbid medical conditions such as diabetes, cardiovascular diseases, and cancer will be exclusionary criteria. In particular, individuals with co-morbid inflammatory disorders such as Crohn's disease and ulcerative colitis and other autoimmune disorders will be excluded. Any uncontrolled medical condition that is deemed by the investigators to interfere with the proposed study procedures, or put the study participant at undue risk will also be considered exclusionary criteria.

 Chronic infections - individuals with chronic infections will also be excluded because of effects on immune markers measured in study.

 Co-morbid pain disorders - individuals with co-morbid pain disorders such as fibromyalgia will also be excluded. Individuals with fibromyalgia have been found to have sleep abnormalities as well as daytime fatigue and pain and thus could confound findings.

 Psychiatric disorders - current conditions such as major depressive disorder, bipolar disorder and risk for suicide will also be considered exclusionary criteria.

 Gender-based criteria - pregnant or breast-feeding women will also be excluded because of their effects on neuroendocrine systems and sleep


Yellow Fever Vaccination Under Low Dose Methotrexate Therapy

Summary: Travelers (n = 30, 15 taking low-dose methotrexate (MTX), 15 healthy controls (HC), seeking travel advice in one of the following Swiss Travel Centers (Aarau, Basel, Bern, Geneva, Lausanne, Zurich) and who have an indication for yellow fever (YF) vaccination according to the Swiss Federal Office of Public Health's vaccination recommendations are invited to participate in this study. After signing the consent form (i) YF viremia and (ii) anti-YF antibody production in patients taking low-dose MTX and HC will be compared after YF vaccination. It will be analyzed whether the percentage of people with protective antibodies differs between the two groups and (iii) vaccine side effects will be compared between the groups.
Inclusion criteria: inclusion criteria:

 Informed Consent as documented by signature

 Indication for yellow fever vaccination according to Swiss FOPH recommendations

 Individuals under low dose MTX (≤20mg/week) therapy or healthy individuals

 Male and Female travelers ≥18 years to <60 years of age

Exclusion criteria: :

 Contraindications on ethical grounds

 Women who are pregnant or breast feeding

 Contraindication against yellow fever vaccination (e.g. hypersensitivity against vaccine ingredient)

 Current treatment with other immunosuppressive agent apart from low dose methotrexate

 Alemtuzumab or rituximab in the last year

 TNF-blocking therapy in past three months

 Immunocompromising condition in healthy control

 Other immunocompromising condition than MTX treatment itself and the underlying disease in patients under MTX

 Previous yellow fever vaccination

 No indication for yellow fever vaccination according to Swiss travel vaccination recommendations

 Known or suspected non-compliance, drug or alcohol abuse

 Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant


In Vivo Alzheimer Proteomics

Summary: In France, an estimated 860 000 patients are affected by Alzheimer Disease (AD) which represents, as in other developed countries, a major public health issue. In many cases, AD diagnosis is uncertain and its clinical evolution unpredictable. The exactitude of the diagnosis is however particularly important in the perspective of the validation and use of new therapeutic strategies in AD. Detection of cerebrospinal fluid (CSF) diagnosis biomarkers fell short in the detection, of atypical/mixed cases, of some differential diagnosis, and in differentiating rapid or slow clinical evolutions. Hence, CSF analysis gives a unique opportunity to detect and validate biomarkers in many neurological disorders. Nevertheless, in medical practice, CSF biological analysis is currently limited to a small number of analytes.Quantitative and targeted mass spectrometry, especially operated in the Multiple reaction monitoring mode (MRM), represents an alternative to immunodetection and could be used to detect specific biomarkers in complex matrices such as plasma by specifically discriminating the proteotypic peptides corresponding to each proteins. Mass spectrometry has also the ability to distinguish and quantify isotopically labelled and unlabeled selected targets. This ability was used in a publication by the group of R. Bateman (Washington University, St Louis, USA) who could, after administering stable isotope-labelled leucine, evaluate Ab synthesis and clearance in humans. This approach has an enormous potential to study the metabolism of proteins within the human CNS and consequently help in the understanding and diagnosis of neurological disorders.The main objective of this program is set up a targeted quantitative mass spectrometry method for existing and stable isotope-labelled CSF biomarkers in the neurological field; exploit this approach for diagnostic purpurses and to gain knowledge in the pathophysiology of diseases.
Inclusion criteria: inclusion criteria:

 Reports written consent, informed and signed by the patient and a trusted person

 Subject member or beneficiary of a social security system

 Specific criteria for group 1 and 2B :

 Age between 55 and 85 years old for patients

 Subject with AD or other neurodegenerative disease (frontotemporal dementia, dementia with Lewy bodies, Parkinson disease)

 Subjects with chronic adult hydrocephalus (HCA) requiring depletion lumbar puncture (PL)

 Specific criteria for group 2A :

 - Adult patient requiring neurosurgery with CSF shunt (subject with brain trauma, acute hydrocephaly) and favorable evolution that allows removal of the shunt

Exclusion criteria: :

 Patient deprived of liberty by judicial or administrative decision

 Major protected by law

 Pregnancy, women of childbearing age with risk of pregnancy, or breast-feeding

 Presence of a transmissible viral disease (HlV, hepatitis B and C)

 Patient included in a clinical trial

 lnadequate cardiac, hepatic or severe renal disfunction

 Disease amino acid metabolism (Leucinose..)

['administration of stable isotope-labelled leucine-', 'collection of CSF, blood, urine, saliva']

['Probable Alzheimer Disease', 'Parkinson Disease', 'Neurological Disease Without Cognitive Degradation', 'Brain Trauma', 'Acute Hydrocephaly']


Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections

Summary: The purpose of this study was to compare the rate of surgical site infections in patients randomized to Irrisept versus SoC, who had an open abdominal laparotomy for abdominal trauma or acute surgical abdomen.
Inclusion criteria: inclusion criteria:

 Is male or female, 18 years of age or older

 Has provided written informed consent or has surrogate consent provided by a Legally Authorized Representative (LAR)

 Has experienced abdominal trauma, blunt or penetrating, requiring open abdominal laparotomy with primary closure or

 Has experienced acute surgical abdomen requiring open abdominal laparotomy with primary closure

Exclusion criteria: :

 Known allergy to Chlorhexidine Gluconate (CHG)

 Estimated Abbreviated Injury Scale (AIS) score of six (6) at the time of surgery, for all trauma patients

 American Society of Anesthesiologists Physical Status Classification (ASA) score of five (5) or greater (As ASA scoring is a subjective measure, if the PI finds the patient stable enough for study participation despite a score of 5, enrollment may continue.)

 Female volunteers who are pregnant and/or breast feeding

 Damage control laparotomy

 Abdominal incision created prior to operating room (i.e. incision made in trauma bay to cross clamp the aorta)

 Currently enrolled in an ongoing, interventional, randomized clinical trial

['IrriSept System', 'No Intervention - Standard of Care (SoC) only']


HealthSpark 2: Improving Asthma Care for Preschool Children

Summary: From a previous community needs survey, we determined that asthma was a particular problem in our community-based research network of child care centers. This study will examine whether a moderate intervention can help these centers improve their asthma-friendly rating as per NHLBI guidelines. We will both center directors and parents to establish baseline data on child health and the asthma-friendliness of each center. We will use a wait-list control, with all centers eventually receiving the intervention.
Inclusion criteria: inclusion criteria:

 Children ages 1 - 5 years, enrolled in one of the designated SPARK child care centers

Exclusion criteria: :

 Children under the age of 1 year

 Children whose parents do not want to participate

 Children whose child care centers do not want to participate


Gene Mutations in Secondary Pulmonary Hypertension

Summary: As a pulmonary hypertension center, we have created a database that prospectively tracks patients with different forms of secondary pulmonary hypertension. Records include genetic analysis, and clinical and hemodynamic profiles.
Inclusion criteria: inclusion criteria:

 Diagnosis of CTEPH and patient consent

Exclusion criteria: :

 No patient consent

['Chronic Thromboembolic Pulmonary Hypertension']


Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE)

Summary: The purpose of this study is:~To assess the efficacy of a lipid-lowering agent (atorvastatin) on the development of atherosclerosis that predisposes children with SLE to cardiovascular events in adulthood.~To assess the safety of intermediate-term (36 months) treatment of children and young adults with atorvastatin.~To further characterize the course of SLE in children and young adults, by establishing a cohort of pediatric SLE patients to be followed prospectively.~To establish a mechanism for conducting clinical trials in rare pediatric rheumatic diseases using the Children's Arthritis and Rheumatology Research Alliance (CARRA).
Inclusion criteria: inclusion criteria:

 Meets American College of Rheumatology (ACR) revised diagnostic guidelines for SLE

 Weight of 25 kg (55 lbs) or more

 Outpatient

 Ability to complete self-report questionnaires in either English or Spanish

 Willingness to comply with recommended diet

 Acceptable methods of contraception

Exclusion criteria: :

 Drug-induced lupus

 Liver disease (ALT or aspartate aminotransferase greater than 2 X normal value)

 Myositis (CK greater than 3 X normal value)

 Inability to obtain adequate-quality IMT images

 Current use of oral or parenteral tacrolimus or cyclosporine

 Dialysis or serum creatinine reater than 2.5 mg/dL

 Active nephrotic syndrome (urinary protein greater than 3 g/24 h and serum albumin less than 2.3 g/dl)

 Total cholesterol greater than 350 mg/dL

 Xanthoma

 Familial hypercholesterolemia

 Pregnant or breastfeeding

 Use of estrogen-containing contraceptives (e.g., Lo-Ovral)

 Unable to adhere to study regimen

 Life-threatening non-SLE illness that would interfere with ability to complete the study

 Current drug or alcohol abuse

 Anticipated poor compliance

 Participation in another drug intervention study within 30 days of study enrollment


PROSPER: PostpaRtum PrOphylaxiS for PE Randomized Control Trial Pilot

Summary: The purpose of this study is to determine if it is feasible to conduct a multi-center randomized trial to determine whether a blood thinner, low-molecular-weight-heparin (LMWH), is effective at preventing blood clots, thromboembolism (VTE), in postpartum women at risk.
Inclusion criteria: inclusion criteria:

 Women must be at high risk for thromboembolism for one of the following reasons:

 Known low risk thrombophilia (Known = diagnosed prior to enrollment and low risk thrombophilia includes heterozygous factor V Leiden or prothrombin gene variant or protein C deficiency or protein S deficiency. If not previously tested then assumed not to have thrombophilia).

 Immobilization (defined as >90% of waking hours in bed, of a week or more at any point in the antepartum period).

 OR any two of the following reasons:

 Postpartum infection (fever (temperature>38.5oC) and clinical signs/symptoms of infection and elevated neutrophil count (higher than local lab normal))

 Postpartum hemorrhage (Estimated blood loss >1000 ml during delivery and postpartum)

 Pre-pregnancy BMI >25 kg/m2

 Emergency cesarean birth (emergency = not planned prior to onset of labour)

 Smoking >5 cigarettes per day prior to pregnancy

 Preeclampsia (blood pressure ≥ 140mmHG systolic and/or ≥90 mmHg diastolic on at least one occasion and proteinuria (1+ on urine dipstick or 300mg/dl or total excretion of 300mg/24 hours) or typical end-organ dysfunction.

 Infant birth weight (adjusted for sex and gestational age) <3rd percentile (i.e., small for gestational age).

Exclusion criteria: :

 Less than 6 hours or more than 36 hours since delivery at the time of randomization

 Need for anticoagulation as judged by the local investigator, may include but not limited to:

 Personal history of previous provoked or unprovoked VTE (DVT or PE)

 Continuation of LMWH that was started in the antenatal period for VTE prophylaxis

 Mechanical heart valve

 Known high-risk thrombophilia (Known = diagnosed prior to enrolment and high-risk thrombophilia includes deficiency of antithrombin (at least 1 abnormal lab result), persistently positive anticardiolipin antibodies (> 30U/ml on two measurements a minimum of six weeks apart), persistently positive Anti B2 glycoprotein antibodies (> 20U/ml on two measurements a minimum of six weeks apart), persistently positive lupus anticoagulant (positive on two measurements a minimum of six weeks apart), homozygous factor V Leiden (FVL), homozygous prothrombin gene mutation (PGM), compound heterozygosity factor V Leiden (FVL) and prothrombin gene mutations (PGM), more than 1 thrombophilia (any combination of 2 or more: FVL, PGM, protein C deficiency, protein S deficiency). If not previously tested then assumed not to have thrombophilia).

 Contraindication to heparin therapy, including:

 History of heparin induced thrombocytopenia (HIT)

 Platelet count of less than 80,000 x 106/L on postpartum Complete Blood Count(CBC)

 Hemoglobin ≤ 75 g/L on postpartum CBC

 Active bleeding at any site (not resolved prior to randomization)

 Excessive postpartum vaginal bleeding (>1 pad per hour prior to randomization).

 Documented gastrointestinal ulcer within 6 weeks prior to randomization

 History of heparin or LMWH allergy

 Severe postpartum hypertension (systolic blood pressure (SBP) > 200mm/hg and/or diastolic blood pressure (DBP) > 120mm/hg)

 Severe hepatic failure (INR >1.8 if liver disease suspected)

 Have received more than one dose of heparin or LMWH since delivery

 < age of legal majority in local jurisdiction (age <18 in Canada)

 Prior participation in PROSPER

 Unable or refused to consent


Anticoagulation Post Laparoscopic Splenectomy

Summary: Splenic/portal vein thrombosis is an alarming complication of splenectomy. Retrospective studies in the literature have shown the incidence of symptomatic splenic/portal vein thrombosis to be between 0.7% (Rattner et al., 1993) to 8% (Winslow et al., 2002). This is a single-center, prospective, randomized study in subjects undergoing laparoscopic splenectomy. All participants will receive one dose of pre-operative low molecular weight heparin (Lovenox®) subcutaneously, 2 hours prior to surgery. Participants will be randomized pre-operatively to treatment or control group however the treatment allocation will not be revealed until the surgery is complete. Postoperatively, those assigned to the treatment group will receive 40 mg of Lovenox® subcutaneously once a day for 21 days; those in the control group will not. Patients with severe renal impairment will receive an adjusted dose of Lovenox® (30 mg subcutaneous dose daily). All patients will have a baseline abdominal Doppler ultrasound preoperatively and a second one done at 14 to 28 days post surgery to monitor for the presence of portal vein and/or splenic vein thrombosis. They will also have their lipase and liver function tests checked to correlate with the imaging findings.
Inclusion criteria: inclusion criteria:

 Scheduled to undergo laparoscopic splenectomy at The University of Alberta or Grey Nun's Community Hospitals

 Capable of understanding the purpose and risks of the study and willing/able to sign a statement of informed consent

 Willing to undergo daily subcutaneous injections of Lovenox®

Exclusion criteria: :

 Pregnant or nursing

 Unable or unwilling to provide informed consent

 Bleeding diathesis or currently on anticoagulation therapy (i.e. coumadin, heparin, LMWH)

 Hemorrhagic cerebral vascular accident

 Severe uncontrolled hypertension

 Diabetic or hemorrhagic retinopathy

 Contradictions to anticoagulation (i.e. active GI bleed, gastric or duodenal ulcer, sustained platelet count < 50 x103/uL, splenectomy due to trauma or history of heparin induced thrombocytopenia)

 Conversion to open splenectomy

 Allergy to Lovenox®, heparin, or other low molecular weight heparins

 Bacterial endocarditis

['Portal Vein Thrombosis', 'Splenic Vein Thrombosis']

Portal Vein Thrombosis
Splenic Vein Thrombosis


Study of the Preservation of the Left Colic Artery on Rectum Cancer Surgery

Summary: To evaluate the influence to the blood supply of the anastomosis and the harvest of the No. 253 lymph nodes in different surgical methods--- preserving the left colic artery (LCA) and resect the No. 253 lymph node specifically in the radical resection of rectal carcinoma or dividing at the root of the inferior mesenteric artery (IMA) in the radical resection of rectal carcinoma.
Inclusion criteria: inclusion criteria:

 Patients coming to FirstJilinU diagnosed rectum cancer by endoscopy and pathology.

 The rectum cancer is the first malignant neoplasm the patient has got.

 The cancer is solitary, and is 3cm to 20cm to the anus.

 The surgical method is limited to Dixon.

Exclusion criteria: :

 Being in the acute phase of inflammation before operation and emergency surgery.

 Patients receiving steroid medication or preoperative radiotherapy。

 Discovering macrometastasis before or in the operation.

 The rectum cancer that can't be radical resected.

['preserving the left colic artery', 'not preserving the left colic artery']

preserving the left colic artery
not preserving the left colic artery


Effectiveness of Calcium Channel Blockers and Adenosine in the Emergency Management of SVT

Summary: The purpose of this study is to determine the efficacy and effectiveness of calcium channel blockers and adenosine in the treatment of Supraventricular Tachycardia.
Inclusion criteria: inclusion criteria:

 More than 10 years old

 Electrocardiographic diagnosis of SVT

 SVT not converted by the vagal manoeuvres

Exclusion criteria: :

 Signs of impaired cerebral perfusion

 Signs of pulmonary oedema

 Subsequent diagnosis of other types of arrythmias rather than SVT

 pregnancy by history


Short-course Antimicrobial Therapy for Paediatric Respiratory Infections

Summary: Randomized controlled double-blind non-inferiority clinical trial to determine whether five days of high-dose amoxicillin leads to comparable rates of early clinical cure compared with 10 days of high-dose amoxicillin for previously healthy children with mild community-acquired pneumonia.
Inclusion criteria: inclusion criteria:

 Children aged 6 months to 10 years presenting with CAP will be eligible. CAP will be defined if all of the four following numeric criteria are met:

 fever (>37.5 C axillary, > 37.7 C oral, or >38 C rectal) recorded in the ED or at home in the 48h prior to presentation;

 any one of:

 tachypnoea on exam (>60 bpm for age <1 y, >50 bpm for 1-2 y of age, >40 bpm for 2-4 y of age, and >30 bpm for >4 y of age);

 cough on exam or by history;

 increased work of breathing on exam; or

 auscultatory findings (focal crackles, bronchial breathing, etc.) consistent with pneumonia;

 infiltrates on chest radiograph consistent with bacterial CAP as judged by the ED physician; and

 the attending ED physician diagnoses the child with primary CAP. (Children treated with systemic steroids in the ED will be presumed to have primary asthma exacerbation with possible infection and therefore will not meet inclusion criteria.)

 Participants must be well enough to be treated as outpatients (discharged home by the ED physician, adequate volume status, able to tolerate oral medication, oxygen saturation > 90%, no evidence of impending respiratory failure), and have no evidence of empyaema or necrotizing pneumonia on chest radiograph.

Exclusion criteria: :

 Children will be excluded if they have any of the following: cystic fibrosis, anatomic lung disease, bronchiectasis, congenital heart disease, history of repeated aspiration or velopharyngeal incompetence, malignancy, conditions requiring treatment with immune suppressants, primary immunodeficiency, advanced HIV infection, prolonged admissions (>48 h) to hospital within the past 2 months, pneumonia previously diagnosed within the past month, lung abscess diagnosed within the past six months, receipt of > 24 hours of beta-lactam antibiotic therapy already received at presentation to the ED, receipt of at least a 5 day course of amoxicillin < 72h prior to presenting to the ED, receipt of an intravenous cephalosporin or azithromycin in the ED, or suspected allergy to penicillin. Children will not be eligible to participate more than once.


Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever

Summary: Abstract Background Tick-Borne Relapsing Fever (TBRF) is an acute febrile illness. In Israel, TBRF is caused by Borrelia persica and is transmitted by Ornithodoros tholozani ticks. We examined the safety and efficacy of a post exposure treatment policy to prevent TBRF.~Methods In a double blind, placebo controlled trial 93 healthy volunteers with suspected tick exposure (51 with bite signs and 42 contacts) were randomly assigned to receive either Doxycycline (200 mg for the first day and 100mg/d for 4 days) or placebo, approximately 2 days after contact. Blood smears were examined for Borrelia at inclusion and during fever rise. Serology for Lyme disease cross- reactivity and PCR for Borrelia GlpQ gene were also performed. Cases of TBRF were defined as subjects having fever and a positive blood smear.
Inclusion criteria: inclusion criteria:

 suspected exposure to tick-borne relapsing fever

 after returning from field exercise in a tick-borne relapsing fever infected area

 having a tick bite or staying in field in close proximity to a subject with tick bite sign

Exclusion criteria: :

 known sensitivity to tetracycline or doxycycline

 febrile illness on recruitment

['Relapsing Fever, Tick-Borne', 'Jarisch Herxheimer Reaction']

Relapsing Fever
Tick-Borne
Jarisch Herxheimer Reaction


Use of Cast Iron Pots to Improve Maternal Anemia

Summary: Anemia of pregnancy is defined as a hemoglobin concentration of less than 11 g/dL in the first and third trimesters, and less than 10.5 g/dL in the second trimester. The rates of anemia are variable and depend largely on preexisting iron stores and supplementation. Estimates from the World Health Organization report that 35% to 75% of pregnant women in developing countries and 18% of women from industrialized countries are anemic. Maternal anemia is associated with an increased risk of preterm birth, low birthweight, and small for gestational age infants. Many studies have shown improvement in these outcomes with maternal iron supplementation in cases of iron-deficiency anemia. Mounting evidence also indicates that maternal iron deficiency in pregnancy reduces fetal iron stores, perhaps well into the first year of life.~Anemia in pregnancy can also impact maternal morbidity and mortality. Viteri reported that anemic pregnant women are at greater risk of death during the perinatal period and that anemia is the major contributory or sole cause of death in 20-40% of the 500,000 maternal deaths per year.~The need for iron averages close to 1000mg in a typical singleton gestation. This amount considerably exceeds the iron stores of most women and will result in iron-deficiency anemia unless supplemental iron is taken. One problem with iron supplement use is compliance, secondary to adverse effects such as constipation and nausea. Research on the use of cast iron pots in decreasing the incidence of iron-deficiency anemia in non-pregnant women has been promising. These studies have demonstrated good compliance with no reported adverse effects. The aim of our study is to determine if providing anemic women in the first trimester of pregnancy with a cast iron pot will decrease the incidence of anemia later in pregnancy.~Hypothesis: Cooking in cast iron pots will increase hematocrit levels in pregnancy.
Inclusion criteria: inclusion criteria:

 Pregnant women of any age in their first trimester of pregnancy with anemia defined as a Hemoglobin less than 11 and/or a hematocrit less than 33

 Willingness and ability to cook in provided cast iron pot at least 3x/week

 Singleton gestations

Exclusion criteria: :

 Any secondary cause of anemia including inherited and acquired hemolytic anemias (sickle cell disease, thalessemia, malaria, etc) Inability or unwillingness to try to use cast iron pot approximately 3x/week

 Women with severe chronic illness and high likelihood of preterm birth and/or expected long-term hospitalizations during pregnancy. Multifetal gestations


The DETEcT Study - Delirium in Elderly paTiEnts Admitted to Trauma

Summary: Primary objectives are to define incidence and prevalence of Delirium in an elderly population admitted to the Department of Orthopedics and Traumatology and, in the postoperative phase, in the high Dependency Unit as well as to determine the presence of risk factors. Secondary objectives are to determine mean hospital stay, rates of complications as well as in-hospital mortality and at 1-3 and 12 months after discharge, functional recovery and cognitive outcomes at 1, 3 and 12 moths follow-up.
Inclusion criteria: inclusion criteria:

 Patients with any medical condition with an age of 65 years and older

Exclusion criteria: :

 Impossibility to give an informed consent; refusal

['Delirium', 'Bone Fractures', 'Multiple Trauma']