Exenatide for the Treatment of Weight Gain Associated With Olanzapine in Obese Adults

Summary: The purpose of this research study is to test the safety and efficacy (how well it works) of exenatide as a treatment for weight gain associated with olanzapine in obese adults with Bipolar Disorder, Major Depressive Disorder, Schizophrenia or Schizoaffective Disorder~Exenatide has been approved by the FDA for the treatment of Type 2 diabetes.~It has not been approved for the treatment of weight gain associated with olanzapine in obese adults with bipolar disorder, Major Depressive Disorder, Schizophrenia or Schizoaffective Disorder
Inclusion criteria: inclusion criteria:

 Subjects must be between the ages of 18 and 55 years old.

 Subjects must have bipolar I disorder, schizophrenia, schizoaffective disorder or MDD as defined by DSM-IV-TR criteria and diagnosed using the Structured Clinical Interview for DSM-IV (SCID).

 Subjects must have a Young Mania Rating Scale (YMRS) score < 16 and a Montgomery-Asberg Depression Rating Scale (MADRS) score < 24 at screening and baseline visits.

 Subjects must have the Scale for the Assessment of Positive Symptoms (SAPS) scores <2 on all subscales.

 Subjects must have gained > 7% of their body weight following treatment with olanzapine as either documented in their medical records or by patient report.

 Subjects must be obese, as defined by a current Body Mass Index (BMI) > 30 kg/m2.

 Subjects 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 method(s) of contraception (e.g., hormonal methods, intrauterine device, abstinence) for at least one month prior to study entry and throughout the study.

 Subjects must be on a stable dose of olanzapine for at least 14 days and must have been on 5-30mg/day for at least 1 month.

 Major
Exclusion criteria:

 Subjects with clinically significant suicidal or homicidal ideation.

 Subjects who have a DSM-IV lifetime diagnosis of a substance dependence disorder within the past 6 months or within the past month have been diagnosed with a substance abuse disorder, (except for nicotine abuse or dependence), as determined by psychiatric history or SCID interview.

 Subjects with a clinically significant or unstable medical disease, including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions, that could interfere with diagnosis, assessment, or treatment of bipolar disorder or obesity, as well as subjects with a history of pancreatitis.

 Patients with clinically significant laboratory abnormalities (> 3 times upper limit of normal), on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, lipid profile, fasting glucose, urinalysis, or thyroid indices or clinically abnormal ECG.

 Female patients who are either pregnant or lactating.

 Any female patient whose sexual activity is unknown or in questions.

 Any history of current or past diabetes that has been treated with pharmacological intervention. Subjects who have a diagnosis of diabetes, are currently receiving exenatide, insulin, or an oral anti-hyperglycemic medication, or who have a nonfasting blood glucose ≥ 200 mg/dl or a fasting blood glucose ≥126 mg/dl on 2 separate tests. Subjects with pre-diabetes will not be excluded.

 Neurological disorders including epilepsy, stroke, or severe head trauma. Mental retardation (IQ <70).

 10. Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections and day 0.

 11. Treatment with concurrent mood stabilizers (except lithium), anticonvulsants, or antipsychotics.

 12. Other psychotic disorders (including delusional disorder, brief psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV.

 13. Dysthymic disorder or depressive disorder not otherwise specified, bipolar disorder not otherwise specified.

 14. Subjects previously enrolled in this study or have previously been treated with exenatide.

 15. Subjects who have received an experimental drug within 30 days. 16. Subjects who are displaying current clinically significant depressive or manic symptoms, defined as a MADRS score >24 or a YMRS score > 16 or who currently meet DSM-IV-TR criteria for a manic, mixed, hypomanic, or depressive episode.

 17. Subjects who are displaying current clinically significant psychotic symptoms, defined as any SAPS subscale score > 2 18. Subjects with a history of pancreatitis in themselves or any risk factors for developing pancreatitis (risk factors include but are not limited to: alcohol use, history of gallbladder disease or gallstones, diabetes or a family history of pancreatitis) 19. Subjects with elevated amylase or lipase levels as measured at the screening visit


Fibrin Based Adhesive for the Prevention of Surgical Complications in the Kidney Transplantation

Summary: Globally there have been about 45,000 kidney transplants last year. Currently, the overall survival of renal transplant receptors is 95% in the first year and 85% at 5 years. A major challenge to overcome by the renal transplant surgeons, are surgical complications which may impact on patient morbidity and mortality, as well as graft function.~The aim of the study is to assess whether application of fibrin seal prevents postoperative complications in patients undergoing kidney transplantation.~Controlled clinical trial with single-blind evaluation in patients surgically intervened kidney transplantation. It will include all patients undergoing renal transplantation in this Medical Center, any gender and over than 16 years and under 60 years.
Inclusion criteria: inclusion criteria:

 Patients candidates to renal transplantation

Exclusion criteria: :

 Patients with known allergy to products of fibrin seal

['Vascular Postoperative Complications', 'Urological System Complication of Procedure', 'Lymphocele', 'Postoperative Infection']


Regulation of Vascular Thrombosis in Sleep Apnea

Summary: Sleep Apnea is a prevalent condition that has been increasingly diagnosed in the adult population and is now considered an independent risk factor for the development of cardiovascular disease. A better understanding of the mechanisms associated with the development of cardiovascular disease in sleep apnea is needed.~This research will investigate the function of the adenosine deaminase (ADA) in subjects with sleep disorders. This enzyme is responsible for metabolizing adenosine, a neuromodulator that is released during periods of sleep apnea and that has been found to promote vascular thrombosis. There are multiple types of ADA that are genetically determined and have different levels of function. Those different forms of this enzyme may determine groups that are more susceptible to the development of thrombosis. Given the known association between sleep apnea and thrombosis, this study will determine if polymorphisms of this enzyme are differentially found in subjects with sleep apnea as compared to other sleep disturbances. The overall objective of this experiment is to assess the presence of ADA polymorphisms in sleep apnea.
Inclusion criteria: inclusion criteria:

 21 years or older

 Patient of the Weill Cornell Pulmonary Associates and Cornell Center for Sleep Medicine practices

 Clinically indicated for an overnight sleep study within six months prior to or after the outpatient office visit

Exclusion criteria: :

 Pregnancy


Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients

Summary: In this multi-center international study, our aim is to determine the effectiveness of HCQ for primary thrombosis prophylaxis in persistently aPL-positive but thrombosis-free patients without systemic autoimmune diseases.
Inclusion criteria: inclusion criteria:

 Persistent(at least 12 weeks apart)aPL-positivity within 12 months prior to the screening defined as:

 aCL IgG/M (>40U,medium-to-high titer,and/or greater than the 99th percentile)and/or

 aβ2GPI IgG/M(>40U, medium-to-high titer, and/or greater than the 99th percentile)and/or

 Positive LA test based on the International Society of Thrombosis & Haematosis Recommendations

 Selected
Exclusion criteria: :

 History of thrombosis (arterial, venous, and/or biopsy proven microthrombosis

 History of Transient Ischemic Attack Confirmed by a Neurologist

 SLE Diagnosis based on the ACR Classification Criteria > 4/11

 Other Systemic Autoimmune Diseases diagnosed based on ACR Classification Criteria

 Current Hydroxychloroquine or another antimalarial treatment (-3 months)

 Current warfarin treatment (-3 months)

 Current heparin therapy( -3 months)

 Current pregnancy

 History of Hydroxychloroquine eye toxicity

 History of Hydroxychloroquine allergy

 Known glucose-6-phosphate dehydrogenase deficiency


Responses Induced by Smoking in Individuals Being Susceptible and Non-Susceptible for Development of COPD

Summary: COPD is ranked number 3 by the WHO list of important diseases worldwide and is the only disease with increasing mortality. The pathogenesis of cigarette smoke-induced COPD is obscure, therefore more insight is needed to design effective anti-inflammatory agents. We hypothesize that healthy individuals who are susceptible to smoking demonstrate a higher and aberrant inflammatory response to cigarette smoke. This susceptibility is caused by heterogeneous factors and is associated with various polymorphic genes that interact with each other and with the environment.~Objective:~To define mediators involved in the early induction of COPD in susceptible smokers (and so to define new drug targets)~To develop new biological and clinical markers for the early diagnosis and monitoring of COPD~To compare between susceptible and non-susceptible individuals the corticosteroid responsiveness of bronchial epithelial cells in vitro, and to study the mechanisms of smoking-induced corticosteroid unresponsiveness.~To study the role of candidate genes that may play a role in the development of fixed airway obstruction, and to identify clues for patient's responsiveness to specific drugs.
Inclusion criteria: inclusion criteria:

 Age 18-75 years

 Age, pack years, FEV1/FVC and FEV1% predicted must fit in one of the 5 groups described above.

 Able to stop smoking for 10 days and start smoking 3-4 cigarettes within 1 hour

 Physically and mentally able to undergo the total study protocol

 Written informed consent

Exclusion criteria: :

 Participation in another study

 Alpha-1-antitrypsin deficiency

 Selected grade 1-3 co-morbidity listed in the ACE-27

 Active pulmonary infection like tuberculosis, pneumonia, flue, tracheobronchitis

 Active extra-pulmonary infection like hepatitis A-C, cystitis, gastro-enteritis etc

 Pulmonary diseases like sarcoidosis, IPF, silicosis, hypersensitivity pneumonitis

 Life threatening diseases like carcinoma, AIDS (including HIV+), acute leukaemia etc

 Medication that may affect the results of the study: NSAID's, immunosuppressive agents like prednisolon, metotrexate, azathioprine,Acenocoumarol

['Chronic Obstructive Pulmonary Disease']


Behavior Therapy for Families of Diabetic Adolescents

Summary: Effective adaptation to type 1 diabetes mellitus requires adolescents and their families to work together effectively to solve problems and resolve disagreements in order to achieve acceptable diabetic control and treatment adherence. Many studies show that problematic family communication, insufficient parental involvement in care and parent-adolescent conflict are associated with poor adherence and poor diabetic control. This study tests a family communication and problem solving intervention by randomizing families of adolescent with type 1 diabetes to 6 months' treatment either with the experimental intervention, continuation in standard medical care for diabetes, or participation in a multifamily educational support group. Families are then followed for an additional 12 months to examine the longer-term effects of the interventions on the targeted diabetes outcomes.
Inclusion criteria: inclusion criteria:

 Age of adolescent 12-<17 years Type 1 diabetes for >2 years Living in a home environment English reading ability at 5th grade level or above Established diabetes care at participating site Working telephone service Intent to remain living in same region for next 18 months -

Exclusion criteria: :

 Presence of another chronic systemic disease Inpatient psychiatric treatment of patient or caregiver in prior 6 months Current outpatient treatment of psychosis, major depression or substance use disorder in parent/caregiver

 -

['Behavioral Family Systems Therapy for Diabetes']


Prenatal Iron and Malaria Study

Summary: The purpose of this study is to compare the presence of Plasmodium infection in parturient women who antenatally received a combination of iron-fortified foods with iron supplements versus iron-fortified foods only.
Inclusion criteria: inclusion criteria:

 Women aged 15-45 years resident in the predefined study area

 Pregnant, with gestational age <23 weeks

Exclusion criteria: :

 Failure to provide a blood sample

 Initial haemoglobin concentration <90 g/L

 Reported medical history suggestive of sickle cell anaemia, epilepsy, diabetes

 Obstetric history suggestive of eclampsia or pre-eclampsia

 Obvious mental retardation or metabolic disorder;

 No written consent

 Carrying multiples

 Woman planning to leave the homestead or to be absent for prolonged periods in the course of the pregnancy or within a 1-month period thereafter

 Woman planning to deliver outside the research clinic.


Argon Plasma Coagulation for Bleeding Peptic Ulcers

Summary: Background:~A second endoscopic method added to injection therapy is recommended for high-risk bleeding peptic ulcers. Many endoscopic devices have been proved as useful hemostatic instruments, whereas the hemostatic efficacy of argon plasma coagulation (APC) has not been widely investigated.~Aim:~This study was designed to know whether additional APC treatment could influence the hemostatic efficacy after endoscopic injection therapy in treating high-risk bleeding ulcers.~Methods:~From October 2010 to January 2012, eligible patients who had high-risk bleeding ulcers were admitted to our hospital. They prospectively randomly underwent either APC therapy plus distilled water injection or distilled water injection alone. Pantoprazole infusion was conducted during the fasting period after endoscopy and orally for 8 weeks to encourage ulcer healing. Episodes of rebleeding were retreated with endoscopic combination therapy. Patients who did not benefit from retreatment underwent emergency surgery or transarterial embolization (TAE).
Inclusion criteria: inclusion criteria:

 (i) over 20 years of age and (ii) patients with high-risk peptic ulcer bleeding.

Exclusion criteria: :

 (i) the presence of another possible bleeding site (eg, gastroesophageal varix, gastric cancer, reflux esophagitis); (ii) coexistence of actively severe ill diseases (eg, septic shock, stroke, myocardial infarction, surgical abdomen); (iii) treatment with an anticoagulant (eg, warfarin); (iv) pregnancy; (v) the presence of operated stomach or; (vi) refusal to participate in the study.

['Argon plasma coagulation', 'Distilled water']

Argon plasma coagulation
Distilled water


Clinical Trial Evaluating the Optimal Technique for Chest Tube Removal

Summary: There are two commonly used methods to remove chest tubes following thoracotomy. One is to remove the chest tube at maximum inspiration, (patient is asked to take a deep breath in and hold it), and the other is to pull the chest tube at maximum expiration,(patient is asked to blow out as much air as they can can and hold it). There has been considerable discussion among Thoracic surgeons that one of these two methods may decrease the risk of pneumothorax, the most common complication associated with chest tube removal. The investigators will compare the two methods, and also identify risk factors of developing pneumothorax during chest tube removal.
Inclusion criteria: inclusion criteria:

 Patients who are post thoracotomy, pulmonary resection (wedge, lobectomy, segmentectomy, pneumonectomy), AND

 Have at least one chest tube.

Exclusion criteria: :

 Less than 19 years old,

 With interstitial lung disease, OR

 Any patient intubated.

['Chest tube pull on inspiration', 'Expiration']

Chest tube pull on inspiration
Expiration


Evaluation of Swallowing in Patients With Obstructive Sleep Apnea

Summary: The purpose of this study is to test the hypothesis that obstructive sleep apnea syndrome is associated with deviant pharyngeal swallowing function, using clinical, endoscopical and manometric evaluation.
Inclusion criteria: inclusion criteria:

 diagnosis of obstructive sleep apnea syndrome

Exclusion criteria: :

 other causes of dysphagia

 pharyngeal surgery

 prior treatment for obstructive sleep apnea

['clinical, endoscopical and manometric evaluation']

clinical
endoscopical and manometric evaluation


Vitamin D Deficiency in Elderly African American Women in Central Texas

Summary: In order to make bone health a reality for older adults, we need to consider the prevalence of Vitamin D deficiency in relation to environment latitude as well as vitamin D supplementation. Darker skin pigmentation and aging are known factors influencing the body's ability to synthesis adequate amounts of Vitamin D. The aim of this project is to document vitamin D deficiency in elderly African American women living in a southern latitude.
Inclusion criteria: inclusion criteria:

 Age 70 or older woman

 African American ethnicity

 Non-institutionalized

Exclusion criteria: :

 De-compensated hepatic insufficiency

 Renal insufficiency with GFR estimated to be < 30 ml/min

 Gastrointestinal disorders that might affect absorption such as known malabsorption, celiac sprue, short gut or blind loop syndrome.

 Institutionalized

['Calcium 500mg with 200 IU Vitamin D - 2 tablets daily', 'Blood levels of Vitamin D, Serum CTX, Mg, Ca++ and iPTH', 'Usual sun exposure documentation', 'Dietary intake of calcium, vitamin D, magnesium']

['Vitamin D Deficiency', 'Osteoporosis', 'Osteopenia']

Vitamin D Deficiency
Osteoporosis
Osteopenia


Cell Mediated Immunity for Secondary Prophylaxis in CMV SOT Patients

Summary: This study will evaluate whether a test for Cytomegalovirus (CMV) specific cell-mediated immunity can be used to determine whether patients who complete a course of therapy for CMV viremia need secondary antiviral prophylaxis. Subjects that have negative CMV CMI will receive antiviral prophylaxis for 2 months and those with positive CMV CMI will have their prophylaxis stopped.
Inclusion criteria: inclusion criteria:

 Adult solid organ transplant (SOT) recipient on at least one immunosuppressive medication

 Starting therapy for new onset asymptomatic CMV viremia OR starting therapy for new onset CMV disease

 CMV viral load ≥ 1000 IU/mL

Exclusion criteria: :

 Known ganciclovir-resistant CMV

 Known intolerance to valganciclovir or ganciclovir

 Unable to comply with protocol


Immunization With Plasmodium Falciparum Sporozoites Under Chloroquine Versus Mefloquine Prophylaxis

Summary: Malaria is one of the major infectious diseases in the world with a tremendous impact on the quality of life, significantly contributing to the ongoing poverty in endemic countries. It causes 800.000 deaths per year, the majority of which are children under the age of five. The malaria parasite enters the human body through the skin, by the bite of an infected mosquito. Subsequently, it invades the liver and develops and multiplies inside the hepatocytes. After a week, the hepatocytes burst open and the parasites are released in the blood stream, causing the clinical phase of the disease.~As a unique opportunity to study malaria immunology and efficacy of immunisation strategies, a protocol has been developed in the past to conduct controlled human malaria infections (CHMIs). CHMIs generally involve small groups of malaria-naïve volunteers infected via the bites of P. falciparum infected laboratory-reared Anopheline mosquitoes. Although potentially serious or even lethal, P. falciparum malaria can be radically cured at the earliest stages of blood infection when risks of complications are virtually absent.~The investigators have shown previously that healthy human volunteers can be protected from a malaria mosquito (sporozoite) challenge by immunization with sporozoites (by mosquito bites) under chloroquine prophylaxis (CPS immunization). Interestingly, sterile protection in 100% of the human CPS immunized volunteers was achieved by a relatively miniscule dose, i.e. a total of 45 infectious mosquito bites, strikingly 20-fold more potent than the 1000 bites needed in a model using irradiated mosquitoes. One possible explanation for this efficient induction of protective immunity, is the immune modulating effect of chloroquine. The investigators aim to assess this possible immune modulating effect in CPS immunization by comparing immunization with P. falciparum sporozoites under chloroquine with immunization under mefloquine prophylaxis, which has the same antimalarial effect, but not the immune modulating effects known from chloroquine.
Inclusion criteria: inclusion criteria:

 Age > 18 and < 35 years healthy volunteers (males or females)

 Good health based on history and clinical examination

 Negative pregnancy test

 Use of adequate contraception for females

 Signing of the informed consent form, thereby demonstrating understanding of the meaning and procedures of the study

 Agreement to inform the general practitioner and to sign a request to release medical information concerning contra-indications for participation in the study

 Willingness to undergo a Pf controlled infection through mosquito bites

 Agreement to stay in a hotel room close to the trial center during a part of the study (Day 5 after challenge till treatment is finished)

 Reachable (24/7) by mobile phone during the whole study period

 Available to attend all study visits

 Agreement to refrain from blood donation to Sanquin or for other purposes, during the whole study period

 Willingness to undergo HIV, hepatitis B and hepatitis C tests

 Negative urine toxicology screening test at screening visit and the day before challenge

 Willingness to take a prophylactic regime of chloroquine or mefloquine and curative regimen of Malarone®

Exclusion criteria: :

 History of malaria

 Plans to travel to malaria endemic areas during the study period

 Plans to travel outside of the Netherlands during the challenge period

 Previous participation in any malaria vaccine study and/or positive serology for Pf

 Symptoms, physical signs and laboratory values suggestive of systemic disorders including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, and other conditions which could interfere with the interpretation of the study results or compromise the health of the volunteers

 History of diabetes mellitus or cancer (except basal cell carcinoma of the skin)

 History of arrhythmias or prolonged QT-interval

 Positive family history in 1st and 2nd degree relatives for cardiac events < 50 years old

 An estimated, ten year risk of fatal cardiovascular disease of ≥5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system

 Clinically significant abnormalities in electrocardiogram (ECG) at screening

 Body Mass Index (BMI) below 20 or above 30 kg/m2

 Any clinically significant deviation from the normal range in biochemistry or hematology blood tests or in urine analysis

 Positive HIV, HBV or HCV tests

 Participation in any other clinical study within 30 days prior to the onset of the study

 Enrollment in any other clinical study during the study period

 For women: pregnancy or lactation

 Volunteers unable to give written informed consent

 Volunteers unable to be closely followed for social, geographic or psychological reasons

 History of drug or alcohol abuse interfering with normal social function

 A history of treatment for psychiatric disease or moderate or severe psychological episode in volunteer

 A history of convulsions in volunteer

 Severe depression, anxiety disorder of psychosis in first or second degree family

 Contra-indications to Malarone®, chloroquine or mefloquine including hypersensitivity or treatment taken by the volunteer that interferes with Malarone®, chloroquine or mefloquine

 The use of chronic immunosuppressive drugs, antibiotics, or other immune modifying drugs within three months of study onset (inhaled and topical corticosteroids and oral anti-histaminic are allowed) and during the study period

 Any confirmed or suspected immunosuppressive or immunodeficient condition, including asplenia

 Co-workers or trainees of the departments of Medical Microbiology, Parasitology, or Internal Medicine of the Leiden University medical Centre

 A history of sickle cell anemia, sickle cell trait, thalassemia, thalassemia trait or G6PD deficiency

['Chloroquine prophylaxis', 'Mefloquine prophylaxis', 'Immunization', 'Controlled Human Malaria Infection', 'Malarone']

Chloroquine prophylaxis
Mefloquine prophylaxis
Immunization
Controlled Human Malaria Infection
Malarone


NovoLog Observation Trial in Subjects With Type 1 and Type 2 Diabetes

Summary: This trial is conducted in the United States of America (USA). The aim of this trial is to assess control of blood sugar, safety, and patient acceptance of insulin aspart compared to insulin lispro, both in insulin pumps, in standard clinical practice.
Inclusion criteria: inclusion criteria:

 People with Type I or Type II Diabetes

 18 Years or Older.
Exclusion criteria:

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

Diabetes
Diabetes Mellitus
Type 1
Diabetes Mellitus
Type 2


Cryotherapy Intervention for Docetaxel-induced Nail Toxicities

Summary: Between 30% and 88% of chemotherapy patients receiving docetaxel experience side effects of the hand ranging from skin and nail disfigurement, blistering, desquamation, pain, infection, and impaired treatment-related quality of life and function. Preliminary data indicate that nurse-initiated cryotherapy during treatment may lower the incidence and severity of these side effects, but several issues should be addressed before this intervention is implemented in hospital settings. These include more rigorous study design, larger sampling frames, and consideration of infection control concerns. This study will address these issues, thereby rigorously evaluating the safety and efficacy of nurse-initiated cryotherapy at Princess Alexandra Hospital.
Inclusion criteria: inclusion criteria:

 patients receiving docetaxel as mono- or combination therapy

 patients with no nail disorders at the start of treatment

 life expectancy of at least 3 months

Exclusion criteria: :

 patients previously treated with taxane chemotherapy

 Raynaud's phenomenon

 distal metastases

 ungual pathology

 arteriopathy

 cold intolerance

 peripheral neuropathy of grade 2 or higher

 patients currently enrolled in clinical trials

['Frozen gel glove (Elasto-Gel Mitten)']


Safety and Tolerability of Oxycyte in Patients With Traumatic Brain Injury (TBI)

Summary: The primary objective of this study is to evaluate the safety and tolerability of a single administration of Oxycyte in patients with severe non-penetrating traumatic brain injury (TBI).~In the first dose level (Cohort 1), 11 patients were randomized 2:1 to receive either 1.0 mL/kg Oxycyte (0.6 g/kg; n=8) or NS (n=3). A total of 8 patients received Oxycyte. The Data Safety Monitoring Board (DSMB) reviewed the safety data for patients in Cohort 1 through Day 14, and approved escalation to the next dose.~In Cohort 2, 18 patients will be randomized 2:1 to receive either 2.0 mL/kg Oxycyte (1.2 g/kg; n=12) or NS (n=6). The DSMB will then review the safety data for all patients in Cohort 2 through Day 14 and either approve escalation to the highest dose or remain at the current dose. If remaining at the current dose level (Cohort 2) an additional 50 patients will be randomized 1:1 to Oxycyte (n=25) or NS (n=25) and treated.~If escalation occurs to Cohort 3, 18 patients would be randomized 2:1 to Oxycyte (n=12) or NS (n=6) to receive the 3.0 mL/kg dose. The DSMB would again review the safety data and decide whether to treat an additional 50 patients at this dose or to decrease the dose back to 2.0 mL/kg. This group would be randomized 1:1 to receive Oxycyte (n=25) or NS.
Inclusion criteria: inclusion criteria:

 Male or female 18 - 70 years of age (inclusive) at the time of study entry

 Weight ≥45 kg

 Able to begin the infusion of study drug within 12 hours of injury

 Evidence of severe non-penetrating traumatic brain injury by clinical evaluation, clinical indication for intracranial pressure (ICP) monitoring, Glasgow Coma Scale (GCS) assessment (4-8 prior to randomization, obtained any time prior to dosing and including patients who deteriorate to severe TBI after arrival in the hospital, not including times when the patient is pharmacologically paralyzed for management or treatment) and with definite anatomic signs of injury on head CT scan (e.g., Marshall Grade II-VI or equivalent)

 At least one reactive pupil at screening. Just prior to study drug administration pupil reactivity must be confirmed again. If the patient is in the peri-postoperative period at that time and reactivity is difficult to assess due to small pupil size, the Investigator will determine if the patient is eligible based on clinical presentation.

 If a patient, due to his or her injuries is unable to provide written informed consent, then written consent may be obtained by an appropriate surrogate decision maker in accordance with preapproved procedures in compliance with local regulations.

Exclusion criteria: :

 Patients who meet any of the following criteria will not be included in the study:

 Physical Assessment:

 Not expected to survive the next 24 hours

 Morbidly obese (BMI >40)

 Absence of a motor response (not including times when the patient is pharmacologically paralyzed for management or treatment)

 Severe unexpected hyperthermia on admission (e.g. >39°C)

 Bilaterally fixed and dilated pupils

 Penetrating traumatic brain injury

 Major liver, kidney, or cardiac injury requiring operative intervention

 Major pulmonary injury, including lung contusion, severe atelectasis, acute respiratory distress syndrome, or acute aspiration pneumonitis

 Severe chronic obstructive pulmonary disease (COPD), pulmonary edema, or congestive heart failure in the judgment of the Investigator

 Laboratory Values:

 Platelet count <100,000/mm3 at screening, prior to transfusion of any platelets

 Neutrophil count <1500 /mm3 at screening

 In the judgment of the Investigator, any clinically significant prolonged clotting time on INR, prothrombin time (PT) or activated partial thromboplastin time (aPTT), or any other coagulation test performed

 One or more of the following liver function test results: Total Bilirubin >2 x upper limit of normal (ULN), ALT >2.5 x ULN, or AST 2.5 > x ULN

 Women with a positive pregnancy test or known to be currently breastfeeding at screening

 Concomitant Medications:

 Known use of immunosuppressive therapy (e.g. TNF inhibitors, methotrexate, cyclosporine, etc.)

 Concurrent use of Plavix® (clopidogrel bisulfate), Pradaxa® (dabigatran elexilate) or an anti- coagulant other than ≤100 mg/day aspirin for any condition

 Known Medical History:

 Immersion injury

 Cardiopulmonary resuscitation (chest compression and/or external cardiac shock) required following the current injury

 Hemodynamically unstable (e.g., requiring >6L colloid or crystalloid fluid as well as >4 units of packed cells within 4 hours prior to enrollment)

 Known or suspected brain tumor

 Known severe allergy to any component of Oxycyte or known severe allergy to eggs

 Known to be immunocompromised (e.g. known history of HIV)

 Known history of major liver disease (e.g., liver failure, necrosis or cirrhosis) or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

 Any known hematological or coagulopathic disorder that, in the Investigator's opinion, is likely to significantly impair platelet function or coagulation (e.g., hemophilia, von Willebrand's disease, myelodysplastic syndrome)

 History of severe TBI (previous to the current TBI) or any prior cerebral injury that required hospitalization and that may, in the Investigator's opinion, interfere with the results of this study

 Known history of any of the following diseases: Parkinson's disease, Huntington's disease, major stroke, seizure disorder, multiple sclerosis or cerebral aneurysm (unless clipped and stable, in which case patient may be included)

 Any life threatening condition prior to the current injury or other diseases or disorders that, in the Investigator's opinion, may put the patient at undue risk or confound the results of the study (e.g signs of soft tissue or other active infection)

 Current participation in another clinical trial with an investigational product, or participation in such a clinical trial within 30 days prior to screening

 Patients serving in the military forces at the time of screening who (if required) do not have the necessary approval from the appropriate authorities


Association Between Low Cortisol Levels and Whiplash Syndrome

Summary: The investigators hypothesis is that low (or low relatively to the situation) cortisol levels might be a causative factor of whiplash injury or post traumatic stress disorder following road accidents. In this study the investigators enroll patients who sustained a road accident. From all patients a blood sample will be withdrawn to measure cortisol concentrations. Than, the patients will be divided into 2 groups: the study group will receive a single injection of intravenous Hydrocortisone 100 milligram (a synthetic steroid used routinely for many years). The control group will receive a same volume of normal saline which would be used as a placebo treatment. The investigators assume that patients with low cortisol levels would tend to have a higher incidence of whiplash injuries and / or post traumatic stress disorders, and that a single bolus of hydrocortisone may prevent these untoward sequelas of trauma.
Inclusion criteria: inclusion criteria:

 victims of motor vehicle accidents

 signed informed consent

Exclusion criteria: :

 pregnancy

 traumatic brain injury

 psychiatry disorders

 active cancerous conditions

 adrenal diseases

 medical treatment by estrogens, anti-depressants, melatonin, pain control.

 substance abuse

 hospitalization due to the trauma

 contra indication to hydrocortisone treatment

 over 6 hours from time of injury

['Hydrocortisone', 'normal saline 0.9%']


GIOP Prevention Among People With Rheumatoid Arthritis

Summary: The ultimate objective of the proposed research is to improve the health-related quality of life of individuals with rheumatoid arthritis by reducing their risk of developing osteoporosis secondary to glucocorticoid therapy. The study has four specific aims.~Specific Aim 1: To obtain descriptive information concerning patients' knowledge, beliefs and behaviors with respect to osteoporosis and osteoporosis prevention.~Specific Aim 2: To identify factors that discriminate among patients in different stages of change with respect to each behavior of interest.~Specific Aim 3: To compare the effects of tailored versus generic educational materials on patient adherence to the ACR Guidelines for the Prevention of Glucocorticoid-Induced Osteoporosis.~Specific Aim 4: To determine if the effects of tailored educational materials are enhanced by concurrent feedback of information concerning patients' behavioral risk factor status to their physicians.
Inclusion criteria: inclusion criteria:

 Meet American College of Rheumatology criteria for rheumatoid arthritis

 Taking an oral glucocorticoid equivalent to 5 mg/day of prednisone for at least one month prior to study entry

 Age 18 or older

Exclusion criteria: :

 Existing osteoporosis

 Pregnancy

 Breast feeding

 History of breast cancer

 Physician recommendation to limit calcium intake

 Class IV rheumatoid arthritis

['Tailored Materials', 'Tailored Materials Plus Physician Feedback', 'Generic Materials', 'No Information']


Microbiology & Immunology of the Chronically-inflamed Airway

Summary: Chronic obstructive pulmonary disease (COPD) is the fourth most common cause of death and the only one of the common causes that is still rising. The main effects of the disease are the destruction and inflammation of lung tissue rendering breathing difficult. COPD has significant effects on the quality of life of sufferers and the disease is predicted to be the fifth most common cause of disability in the world by 2020. Patients with COPD are prone to periods of worsening disease symptoms, known as exacerbations, which are often caused by viral and bacterial infections of the lung and current vaccines appear to have little efficacy in limiting these exacerbations. The loss of lung function caused by infectious exacerbations is irreversible and patients who frequently exacerbate experience more rapid disease progression. Nontypeable Haemophilus influenzae (NTHi) is a major bacterial species that colonises the airways and causes exacerbations in COPD. With the development of more sensitive molecular techniques it has been possible to ascertain that it is the acquisition of new strains of NTHi that correlate strongly with exacerbations. However, not all patients with COPD have NTHi in their lungs and the question remains as to why some COPD patients are susceptible to such infections. This study aims to answer this question by comparing the airways of COPD patients who are colonized by NTHi and those who are not to analyse whether the levels of protective antibodies in the lungs and the function of the immune cells in the NTHi colonized airway are reduced. Moreover, we aim to correlate this reduction in immunity with areas of lung damage ascertained by high resolution computed tomography. The aim of this research is to better understand this apparent deficiency in airway immunity as this is likely to impact on vaccine efficacy in COPD.
Inclusion criteria: inclusion criteria:

 Subjects who the investigator believes can and will comply with the requirements of the protocol.

 Written informed consent obtained from the subject.

 Male or female subjects between, and including, 40 and 85 years of age, at the time of consent.

 Subjects with confirmed diagnosis of COPD (based on postbronchodilator spirometry). [GOLD, 2009] with FEV1 of >80% (mild COPD) or >50% but ≤80% (moderate COPD) of predicted normal and FEV1/FVC<0.7

 Subjects have mild or moderate COPD, according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) staging [GOLD, 2009].

 Subjects have a current or prior history of ≥10 pack years of cigarette smoking. Former smokers are defined as those who have stopped smoking for at least 6 months. Number of pack years = (number of cigarettes per day/20) x number of years smoked.

 Subjects with recent COPD exacerbations, in stable condition, and having stopped antibiotics, can be enrolled one month post exacerbation.

Exclusion criteria: :

 Subject also has a confirmed diagnosis of asthma (as only cause of obstructive respiratory disorder), cystic fibrosis, pneumonia risk factors (e.g., HIV, Lupus, Parkinson's, Myasthenia Gravis) or other respiratory disorders (e.g., tuberculosis, lung cancer).

 Subjects having undergone lung surgery

 Subject has a α1-antitrypsin deficiency as underlying cause of COPD.

 Subject who experienced a moderate or severe COPD exacerbation not resolved at least 1 month prior to enrolment visit and at least 30 days following the last dose of oral corticosteroids (subjects can be enrolled when their acute AECOPD or pneumonia has resolved).

 Subject using any antibacterial, antiviral or respiratory investigational drug or relevant vaccine up to 30 days prior to the enrolment visit.

 Subject has other conditions that the principal investigator judges may interfere with the study findings, such as:

 Subject at risk of noncompliance, or unable to comply with the study procedures.

 Evidence of alcohol or drug abuse.

 Others, as per clinical judgement

 Women who are pregnant or lactating or are planning on becoming pregnant during the study **If subject has any ONE of the above exclusion they cannot be enrolled into the study**

['Chronic Obstructive Pulmonary Disease (COPD)']


Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants

Summary: This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the Vi-CRM197 in subjects from various age groups in India and Pakistan where Typhoid Fever is highly endemic and an efficacious vaccine against this disease is very much needed.
Inclusion criteria: Main eligibility criteria:

 Subjects belonging to 4 age groups will be enrolled into the trial: adults (18 to 45 years of age), children (24 to 59 months of age), older infants (9 to 12 months of age at enrollment) and infants (6 weeks of age at enrolment).

 Written informed consent will be obtained by the all subjects or their parents/ guardians (depending on the age group) before enrollment into the trial.

 Only females with a negative pregnancy test and willing to participate in family planning consultations (organized by the site study team) will be allowed to participate to the trial.

 Infants who have been vaccinated with 1 dose of BCG, HBV and OPV at birth can be enrolled into the trial, while infants who have received DTwP+HBV+Hib or OPV due at 6 weeks of age as per local EPI schedule cannot be enrolled into the trial.
Exclusion criteria:

['Vi-CRM197 vaccine', 'Vi Polysaccharide (PS) vaccine', 'Pneumococcal conjugate vaccine']

Vi-CRM197 vaccine
Vi Polysaccharide (PS) vaccine
Pneumococcal conjugate vaccine


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

Summary: The purpose of the study is to investigate the efficacy and safety of zolpidem modified release (MR) tablet using estazolam (Eurodin) as a comparative drug in patients with primary insomnia.
Inclusion criteria: inclusion criteria:

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

 Written informed consent has been obtained

Exclusion criteria: :

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

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

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

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

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

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

 Participation in any clinical trial within 1 month prior to randomization

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


A Clinical Trial of the Vessel Sealing System (LigaSure) in Azygoportal Disconnection and Splenectomy in Patients With Portal Hypertension

Summary: The aim of this trial was to verify the efficiency of a new surgical device (the LigaSure vessels sealing system) in esophagogastric decongestion and splenectomy in patients with portal hypertension.
Inclusion criteria: inclusion criteria:

 Patients with liver cirrhosis accompanied by portal hypertension and secondary hypersplenism due to hepatitis, alcoholic cirrhosis or schistosomiasis, who undergoing elective azygoportal disconnection and splenectomy

Exclusion criteria: :

 Liver function as Child-Pugh C

 Hemoglobin < 9 g/dL

 Ascites

 Abnormal coagulation


Phase II Multi-Center Study of T89 to Treat Chronic Stable Angina

Summary: The purpose of this study is to determine the anti-angina effect and dose response of T89, a 2-herb botanical drug product, in patients with chronic stable angina pectoris in the United States.
Inclusion criteria: inclusion criteria:

 Patient must be between the ages of 18 and 80 years.

 Females of childbearing potential must have a negative pregnancy test, not be breast feeding and established on a method of contraception that in the investigator's opinion is acceptable. Females must agree to remain on their established method of contraception through their participation in the study.

 Evidence of coronary artery disease that consists of a well-documented medical history (over 3 months prior to the enrollment) of myocardial infarction or significant coronary artery disease with noninvasive or angiographic confirmation.

 Symptoms that support the diagnosis of chronic angina and/or a history of an abnormal exercise response limited by angina and/or electrocardiograph (ECG) changes.

 Moderate angina pectoris (Class II or Class III, Grading of Angina Pectoris by the Canadian Cardiovascular Society Classification System)

 Naive patient or patient who's Total Exercise Duration (TED) is between 3 to 7 minutes in ETT on Standard Bruce Protocol, and the difference in TED must be no more than 15% between the two screen examinations on day -7 and day 0

 All anti-angina regimen (except short-acting nitroglycerin, and one beta-blocker or calcium channel blocker), warfarin or other oral anticoagulants which were used prior to this initial visit can be discontinued.

 Patient must understand and be willing, able and likely to comply with all study procedures and restrictions and comprehends the verbal rating scales and diary cards.

 Patient must be able to give voluntary written informed consent.

Exclusion criteria: :

 With contraindication to perform treadmill Exercise Tolerance Test (ETT).

 Pre-exercise ST-segment depression of at least 1 mm in any lead, left bundle branch block, digoxin therapy, Left Ventricular Hypertrophy (LVH) and Wolff-Parkinson-White (WPW) syndrome or other factors that could interfere with exercise electrocardiograph interpretation.

 Clinically significant arrhythmias or atrioventricular conduction block greater than first degree.

 Clinically significant co-morbidities, including hepatic or renal dysfunction, pulmonary hypertension, chronic obstructive pulmonary disease, history of cerebral hemorrhage, or seizure disorders that required anticonvulsant medication.

 History of congestive heart failure, unstable angina, severe valvular disease, severe hypertension, severe anemia, suspected or known dissecting aneurysm, acute myocarditis or pericarditis, thrombophlebitis or pulmonary embolism or recent myocardial infarction within three months of study entry.

 History of bleeding diathesis, or is on warfarin.

 Implanted pacemaker.

 Aspirin and/or statins started less than 14 days prior to the signing of informed consent.

 Pregnancy or lactation.

 Inability to discontinue existing chronic nitrate regimen (e.g. long acting nitroglycerin) and allow only short-acting nitroglycerin and one beta-blocker or calcium channel blocker.

 Clinical trials/experimental medication:

 Participation in any other clinical trial or receipt of an investigational drug within 90 days prior to initial visit.

 Those patients unable, in the opinion of the investigator, to comply fully with the trial requirements.

 Previous participation in this study.

 Substance abuse. Patients with a recent history (within the last 2 years) of alcoholism or known drug dependence.

 Patient is a family member or relative of the study site staff.


Target Antigens Induced by Plasmodium Falciparum Sporozoite Immunization Under Chemoprophylaxis

Summary: Malaria, a disease caused by the parasite Plasmodium, is one of the world's major infectious diseases. With approximately 627.000 deaths a year, there is desperate need for an effective vaccine. Though a number of vaccine-candidates have been developed, they have yet to achieve the level of efficacy necessary to eliminate malaria. It has been shown previously that healthy human volunteers bitten by malaria-infected mosquitoes while taking chloroquine, medicine that prevents malaria, are fully protected against a subsequent malaria challenge. This is called CPS-immunization. The unprecedented effectiveness of CPS-immunization makes it a good model to identify what immune responses protect against malaria, to further guide vaccine development. In this study we will use CPS-immunization to induce protection against malaria in healthy subjects and then analyse their immune response to a malaria challenge infection.
Inclusion criteria: inclusion criteria:

 Subject is aged ≥ 18 and ≤ 35 years and in good health.

 Subject has adequate understanding of the procedures of the study and agrees to abide thereby.

 Subject is able to communicate well with the investigator, is available to attend all study visits, lives in proximity to the trial centre or is willing to stay in a hotel close to the trial centre during part of the study (day 5 post-infection until three days post-treatment). The subject will remain within the Netherlands during the challenge period, not travel to a malaria-endemic area during the study period, and is reachable (24/7) by mobile telephone throughout the entire study period.

 Subject agrees to inform his/her general practitioner (GP) about participation in the study and to sign a request to release by the GP any relevant medical information concerning possible contra-indications for participation.

 Subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period and for a defined period thereafter according to Sanquin guidelines.

 For female subjects: agrees to use adequate contraception and not to breastfeed for the duration of study.

 Subject has signed informed consent.

Exclusion criteria: :

 Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, which could compromise the health of the volunteer during the study or interfere with the interpretation of the study results. These include, but are not limited to, any of the following:

 1.1 Body weight <50 kg or Body Mass Index (BMI) <18.0 or >30.0 kg/m2 at screening.

 1.2 A heightened risk of cardiovascular disease, as determined by: an estimated ten year risk of fatal cardiovascular disease of ≥5% at screening, as determined by the Systematic Coronary Risk Evaluation; history, or evidence at screening, of clinically significant arrhythmia's, prolonged QT-interval or other clinically relevant ECG abnormalities; or a positive family history of cardiac events in 1st or 2nd degree relatives <50 years old.

 1.3 Functional asplenia, sickle cell trait/disease, thalassaemia trait/disease or G6PD deficiency.

 1.4 History of epilepsy in the period of five years prior to study onset. 1.5 Positive Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) screening tests.

 1.6 Chronic use of i) immunosuppressive drugs, ii) antibiotics, iii) or immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period.

 1.7 History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, in the past 5 years.

 1.8 Any history of treatment for severe psychiatric disease in the past year. 1.9 History of drug or alcohol abuse one year prior to study onset, or positive urine toxicology test for cocaine or amphetamines at screening or prior to infection.

 Females: positive urine pregnancy test at screening or prior to infection.

 Any history of malaria, positive serology for P. falciparum, or previous participation in any malaria study.

 Known hypersensitivity to or contra-indications to any antimalarials, or history of severe reactions to mosquito bites.

 Receipt of any vaccinations in the 3 months prior to the start of the study or plans to receive any other vaccinations during the study period or up to 8 weeks thereafter.

 Participation in any other clinical study in the 30 days prior to the start of the study or during the study period.

 Being an employee or student of the department of Medical Microbiology of the Radboudumc or the department of Internal Medicine.

 Any other condition or situation that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

['CPS-immunization', 'Controlled Human Malaria Infection', 'chloroquine', 'atovaquone/proguanil']

CPS-immunization
Controlled Human Malaria Infection
chloroquine
atovaquone/proguanil


Effects of Remote Ischemic Preconditioning on Restenosis Post Lower Limb Revascularization Angioplasty

Summary: The investigators will established relation between restenosis and inflammatory response to shearing stress caused by angioplasty suggest that any mechanism that affect inflammatory response can consequently affect the restenosis rate. There is accumulated evidence that remote ischemic precondition has modifying suppressive effect on inflammatory response and the investigators hypothesized that RIPC may lead to reduction in post angioplasty restenosis rate.
Inclusion criteria: inclusion criteria

 1. Patients planned for lower limb Angioplasty

Exclusion criteria:

 Known upper limb PVD

 Previous history of upper limb deep vein thrombosis

 Patients on glibenclamide or nicorandil- May affect RIPC

 Raynaud's Disease

 Intra operative decision to use graft - will be documented


Effects of Advair® in Outpatients With Chronic Obstructive Pulmonary Disease (COPD) Acute Exacerbation

Summary: Short course of steroids in COPD exacerbation improves FEV1 and decreases the relapse rate. However, some concerns remain about using systemic steroids for all patients with acute exacerbation. Their short-term advantages may be outweighed by the occurrence of adverse side effects such as hyperglycemia, which is difficult to manage on an outpatient basis. In this context, the possibility of treating patients with COPD exacerbation with inhaled steroids having less systemic adverse effects is interesting. The objectives are to compare relapse rate, lung function, the severity of dyspnea and, systemic and sputum inflammatory markers in outpatients with acute COPD exacerbations treated with fluticasone/salmeterol (Advair®) or oral prednisone for 10 days. The hypothesis is that Advair® is as effective as prednisone in treatment of outpatients with COPD exacerbation. The primary endpoint is to determine if the relapse rate at one month is equivalent for both treatments. The secondary endpoints are to compare lung function and dyspnea score and, systemic and sputum inflammatory markers modulation after 10 days of both treatments. We will recruit 30 outpatients in each group from our COPD clinic. Patients will receive prednisone (40mg/day) with placebo diskus or Advair® 50/500ug 2 inhalations bid (twice the regular dose) with placebo pills for 10 days. All patients will receive antibiotics and short-acting bronchodilators as needed. We expect to demonstrate that the improvement of lung function, dyspnea, inflammatory markers and relapse rate are equivalent in both treatments suggesting that Advair® could be a good alternative to prednisone for patients with steroid-induced hyperglycemia.
Inclusion criteria: inclusion criteria:

 diagnosis of COPD

 history of 15 pack-years or more of cigarette smoking

 evidence of irreversible obstruction (FEV1<70% of predicted value, ratio FEV1/FVC<70%, and improvement of FEV1of less than 20% after bronchodilator in previous respiratory tests done when they were stable)

Exclusion criteria: :

 history of asthma or atopy

 need of being hospitalized

 use of oral or intravenous steroid within the preceding 30 days

 history of multiresistant bacterial infection (not applicable if absence of multi-resistant bacterial infection has been proved by a negative expectoration culture in the previous 6 months), bronchiectasis or recent COPD exacerbation (< 6 weeks) or diabetes.

 oxygen-dependant COPD patients or patients previously known with hypercapnia (PCO2>45 mmHg) at steady state

 use of high doses of Advair (more than 50/500 bid) or Symbicort (more than 12/400 bid)

 known cardiac arrhythmia such as atrial fibrillation, supraventricular tachycardia or paroxysmal auricular tachycardia


Are Serum Levels of Vascular Endothelial Growth Factor a Marker for the Early Diagnosis of Ectopic Pregnancy?

Summary: OBJECTIVE: This study evaluated serum vascular endothelial growth factor (VEGF) concentrations in women with ectopic pregnancy (EP), abnormal intrauterine pregnancy (aIUP) and normal intrauterine pregnancy (nIUP).~METHODS: This was a prospective, case-control study comparing serum VEGF concentrations among 72 women with ectopic pregnancy (n=35), abnormal IUP (n=15) and normal IUP (n=22) matched for gestational age. For the determination of serum VEGF concentration a solid phase sandwich ELISA was used. Patients were stratified according to serum VEGF above or below 200pg/mL.~RESULTS: The serum level of VEGF was significantly higher in women with ectopic pregnancy (median 211.1 pg/mL; range 5 - 1017.0 pg/mL) than in women with normal IUP (median 5 pg/mL; range 5- 310.6 pg/mL) P < 0.0001. Serum VEGF concentrations did not show any statistically significant difference between women with aIUP (median 231.9 pg/mL range 5 - 813.7 pg /mL ) and EP (median 211.1 pg/mL range 5 - 1017.0 pg/mL). When cut-off concentrations of 200 pg/mL for VEGF were used, a nIUP could be distinguished from an unviable (EP and aIUP) with a sensitive of 53%, specificity of 90.9%, a positive predictive value of 92.9% and a negative predictive value of 46.5%..~CONCLUSIONS: Serum VEGF could not distinguish between an EP and an aIUP. However, serum VEGF concentrations above 200 pg/mL could discriminate a nIUP from an unviable pregnancy (EP or aIUP) with a PPV of 92.9%.
Inclusion criteria: inclusion criteria:The inclusion criterion was the presence at transvaginal ultrasound of an extraovarian adnexal mass in women with a suspected ectopic pregnancy (amenorrhea, bleeding and pain) with positive test for beta-hCG.

 -

Exclusion criteria: :The exclusion criterion was non-tubal ectopic pregnancy (cervical, cesarean scar, ovarian, and abdominal).

 -


Using Nasal High Flow From Birth in Premature Infants - a Pilot Study

Summary: Recent large studies have shown that not all premature babies need to be intubated (have a breathing tube inserted) and ventilated, nor do they all need to be given lung surfactant routinely. Those studies showed that even very small babies can be safely supported using nasal Continuous Positive Airway Pressure (nCPAP) which is applied tightly to the nose using nasal prongs. This is a type of noninvasive ventilation (NIV) so that the babies continue to breath, albeit with additional support to reduce their work of breathing. However nCPAP has some drawbacks, including that it can cause skin damage to the nose, and that the heating and humidification of the gas is not always sufficient. We have been using, for over 5 years, a different system to support babies after routine intubation. This is another type of noninvasive ventilation called nasal High Flow (nHF) for which we use a Vapotherm Precision Flow device. Published trials show that it is at least as effective as nCPAP to provide NIV and to prevent the subsequent need for intubation and/or surfactant. However nHF is superior to nCPAP in respect it does not cause nose damage and its heating and humidification is excellent. This pilot study aims to describe and evaluate the use of nHF, using a standard commercially available system (Precision Flow, Vapotherm Inc.), from birth, in babies born less than 30 completed weeks gestation, with a view to avoiding intubation and ventilation. This study is important to establish the feasibility of using nHF immediately after birth.
Inclusion criteria: inclusion criteria:

 Parental consent

 24+0 to 30+0 weeks(agreed dates) gestation born alive

 Breathing spontaneously at birth or soon after with minimal resuscitation

 Oxygen saturations >90% by 5 minutes

Exclusion criteria: :

 No parental consent

 Born in poor condition and unlikely to survive

 Needing resuscitation including intubation and/or chest compressions

 Not breathing and thus needing intubation

 Oxygen saturations <90% by 5 minutes

 <24 weeks gestation

 >30 weeks gestation


Effect of Supplementary Vitamin D in Patients With Diabetes Mellitus and Pulmonary Tuberculosis

Summary: Pakistan ranks fifth amongst high tuberculosis-(TB) burden countries, where TB persists as a major cause of misery and death. The Diabetes Mellitus-(DM) is also on rise in Pakistan and people suffering from DM are more prone to catch TB as compared to healthy individuals. This concurrence of two outbreaks may further increase the frequency of TB in Pakistan. The TB DM co-occurrence results in various clinical issues as TB in DM patient increases blood glucose, making DM more difficult to treat, while DM raises the risk of treatment failure, relapse and death among TB patients. In addition, both DM and TB usually coexist with micronutrients deficiencies like vitamin D, which has a vital role in immunity, insulin functioning and respiratory health. It has been suggested that the combined supplementation with vitamin D and calcium might be beneficial in improving the glucose metabolism but the current knowledge is very limited. In a resource restrained country with double burden of infectious and non-infectious diseases, an integrated approach with modification of treatment options may benefit in management of these outbreaks.~Therefore, this study aims whether vitamin D and calcium supplementation could influence the recovery in patients with TB of lung and DM.
Inclusion criteria: inclusion criteria:

 Age 30 to 60 years

 Patients having both TB and type 2 DM

 Patients consenting to participate

 No history of previous ATT

 Plane to have ATT and DM treatment

Exclusion criteria: :

 Age less than 30 years or greater than 60 years

 Pregnant women

 Patients having either TB or type 2 DM

 Patients refuse to participate

 Patients having extra-pulmonary TB or Multi-drug resistant MDR TB or relapse cases

 Patients having hepatic or renal diseases or HIV infection

 Patients having hypo- or hyper-parathyroidism

 Patients on corticosteroids or immunosuppressive or thiazides diuretics or any other drugs known to interfere with vitamin D levels

['Vitamin D', 'Calcium', 'Placebo Vit D', 'Placebo Calcium']

Vitamin D
Calcium
Placebo Vit D
Placebo Calcium

['Type 2 Diabetes Mellitus', 'Pulmonary Tuberculosis']

Type 2 Diabetes Mellitus
Pulmonary Tuberculosis


Low Level Laser Therapy to Reduce Chronic Pain

Summary: The purpose of this study was to determine whether low level laser light directed at the neck and shoulders could be effective in the temporary reduction of chronic pain in the neck and shoulder region.
Inclusion criteria: inclusion criteria:

 Muscular-skeletal pain in the neck/shoulder region

 Acute and chronic pain in the neck/shoulder region

 Restricted range of motion in the neck/shoulder region

 Fibrosis or scar tissue in the neck/shoulder region

 Inflammation in the neck/shoulder region

 Altered function in the neck/shoulder region

 Muscle strains in the neck/shoulder region

 Rating of 30 or greater on the 0-100 Visual Analog Scale (VAS) pain scale

 18-65 years of age

Exclusion criteria: :

 Severely herniated disks

 Pregnancy

 Taken pain medication within the past 12 hours

['Erchonia PL2000 Laser', 'Placebo laser']


Staccato Loxapine in Agitated Patients With Bipolar Disorder

Summary: Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in bipolar 1 disorder patients.
Inclusion criteria: inclusion criteria:

 Male and female adult patients with bipolar 1 disorder and acute agitation

Exclusion criteria: :

 Agitation caused primarily by acute intoxication

 History of drug or alcohol dependence

 Treatment with benzodiazepines or other hypnotics within 4 hours prior to study drug administration

['Inhaled Placebo', 'Inhaled loxapine 5 mg', 'Inhaled loxapine 10 mg']

Inhaled Placebo
Inhaled loxapine 5 mg
Inhaled loxapine 10 mg


Low-dose CT Using Iterative Reconstruction in Patients With Inflammatory Bowel Disease

Summary: The purpose of this study is to validate the use of a low-dose computed tomography (CT) protocol and facilitate reduced radiation doses in patients with inflammatory bowel disease (IBD). This is to be achieved using new computer software (Iterative Reconstruction and Automatic Tube Modulation) which will enable low-dose CT imaging at doses equivalent to that of an abdominal radiograph.
Inclusion criteria: inclusion criteria:

 Adult patients requiring a CT abdomen for clinical purposes will be included

Exclusion criteria: :

 Pediatric patients

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

Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis


Comparison of the FemoSeal® Arterial Closure Device to Manual Compression After Coronary Angiography

Summary: Is the FemoSeal® closure device safer and more comfortable than manual compression for femoral artery access closure after coronary angiography?
Inclusion criteria: inclusion criteria:

 The patient must be at least 18 years old

 Patients undergoing femoral access coronary angiography

 Patient must be competent for providing informed, written consent

 Only 6F sheath

Exclusion criteria: :

 Percutaneous coronary intervention

 Intra coronary measurements (FFR, IVUS, OCT, NIR)

 Groin hematoma before closure

 Pseudoaneurysm or AV fistula

 Significant stenosis of ilial or femoral artery

 Prior peripheral artery surgery

 INR > 3,0

 Platelet count < 120 million per millilitre blood

 Coagulopathy (bleeding disorder)

 Thrombolysis in the last 24h

 Planned heparin infusion after the procedure

 Pregnancy

 Uncontrolled hypertension > 200 mmHg / 110 mmHg

 Femoral access device closure in the last 30 days

['Coronary Angiography Via Femoral Artery Access']


Severe Pandemic H1N1 Infection in ICU: Comparative Resource Utilization

Summary: The main purpose of this study is to review the resource utilization of severe adult H1N1 pneumonia undergoing antiviral and oxygen therapy, mechanical ventilation and support with pulmonary rescue therapies ( nitric oxide, ECMO, HFO) in critically ill patients in Winnipeg. Secondary objectives include, comparison of resource utilization to other similar disorders (viral pneumonia, bacterial pneumonia, septic shock, ARDS). The investigators will also look at the percentage of patients that required ICU care as compared to those who could be cared for on medical wards. The investigators will determine the resources used by both groups and compare. Finally the investigators will record the frequency of chronic comorbidities in hospitalized adult H1N1 patients.
Inclusion criteria: inclusion criteria:

 > 18years,

 Suspected or confirmed influenza (Appendix A)

 Requirement for ICU admission due to respiratory distress or critical illness defined as one of:a) Inspired oxygen need of >50% for at least 4 hours (For FiO2 for non-intubated patients see Appendix B) b) mechanical ventilation c) Patient is receiving inotrope or vasopressor

Exclusion criteria: :

 1. Age less than 18 years

['We will compare the resources used by both groups']

['Novel H1N1 Influenzal Acute Respiratory Infection']


Therapy for Undergraduate College Students Who Binge Drink and Are Depressed

Summary: The purpose of this study is to investigate the effectiveness of 2 different therapy courses for undergraduate college students who binge drink and experience depressive symptoms.
Inclusion criteria: inclusion criteria:

 Currently enrolled in college as an undergraduate student.

 Ages 18-24 years (inclusive).

 Presence of two binge drinking episodes in the past month (defined as consumption of 5 or more drinks in 2 hours for males and 4 for females; NIAAA, 2004).

 BDI-II 12 (12 is often used to indicate the presence of at least mild depressive symptoms) and <30 (indicating severe depression).

Exclusion criteria: :

 Meeting criteria for substance dependence or abuse (any substance) in the past six months (students with alcohol abuse will not be excluded).

 Diagnosis of bulimia, psychosis, or bipolar disorder.

 Having received any psychosocial treatment for depression or substance abuse in the past month.

 Having received CBT for depression and/or alcohol use in the previous 6 months.

 If receiving pharmacological treatment for depression or substance abuse, has not been on a stable dose for at least 4 weeks.

 Discontinued an antidepressant medication less than 1 month ago.

 Meeting criteria for severe depression or posing a serious suicide or homicide risk.

['Combined Motivational Interviewing and Cognitive Behavioral Therapy', 'Cognitive Behavioral Therapy']


Human Anaplasmosis in Eastern France

Summary: Anaplasmosis is a tick-borne transmitted infection. Its clinical expression include fever, cytopenia and hepatitis.This infection was initially described in United States. In Europe, its epidemiology is not well known. Some isolated cases have been diagnosed in several country, were the tick Ixodes ricinus is known to transmitted another infection :the Lyme borreliosis.The purpose of our study is to look systematically for Anaplasmosis, in patient living in Eastern France, and presenting with compatible clinical symptoms using a new diagnosis tool : PCR in blood samples. So we will have new data about epidemiology in our country and the clinical symptoms that are associated with Anaplasmosis.
Inclusion criteria: inclusion criteria:

 patient with at least one of following symptoms : fever or muscular pain or articular pain or respiratory signs or neurological signs or meningitis or erythema occurring during the three weeks after a tick bite-

 Or

 patient with fever with at least one of following criteria : thrombocytopenia, leucopenia, hepatitis, without any other cause that can explain these abnormalities.

 Or

 patient with tick-borne encephalitis, or primary stage Lyme borreliosis

Exclusion criteria: :

 children less that 10 years

 pregnancy

 patients with an other diagnosis that can explain clinical symptoms or biological abnormalities

 antibiotherapy with cyclins during the days before inclusion

['Anaplasmosis', 'Tick-borne Disease', 'Ehrlichia']

Anaplasmosis
Tick-borne Disease
Ehrlichia


Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery

Summary: The proposed study will investigate the effect of sodium bicarbonate on the prevention of acute kidney injury in children undergoing cardiac surgery with cardio-pulmonary bypass. The investigators hypothesize that the occurrence of acute kidney injury will be less in children treated with sodium bicarbonate in the perioperative period when compared to placebo. The specific aims of this proposal are as follows:~1. To institute a prospective, randomized, double-blinded, placebo-controlled trial in pediatric subjects undergoing cardiac surgery to determine the efficacy of sodium bicarbonate on prevention of acute kidney injury as measured by pRIFLE criteria. 2. To examine whether treatment with sodium bicarbonate modifies the duration of acute kidney injury, fluid balance, hospital length of stay, need for dialysis, and progression to kidney failure. 3. To determine the relevance of NGAL as a biomarker to predict development of acute kidney injury.
Inclusion criteria: inclusion criteria:

 Subjects age ≤18 years

 Subjects scheduled for cardiac surgery with cardiopulmonary bypass

Exclusion criteria: :

 Subjects with abnormal creatinine clearance (<90 ml/min/1.7m2) as measured by the Schwartz formula

 Subjects with known cystic kidney disease or posterior ureteral valves (subjects with solitary kidney, single multicystic/dysplastic kidney, hydronephrosis will not be excluded if renal function is preserved)

 Subjects with known metabolic disorder

 Premature infants born <30 weeks gestation and <30 days old due to risk of intraventricular hemorrhage

 Subjects in severe cardiogenic shock post-operative requiring extra-corporeal membrane oxygenation (ECMO) or left ventricular assist device (LVAD) will be withdrawn from the study.

['Sodium Bicarbonate', 'Sodium Chloride']

['Acute Kidney Injury', 'Congenital Heart Disease']

Acute Kidney Injury
Congenital Heart Disease


Simulated Dawn Med Students

Summary: Medical students score higher than the general population on measures of depression, anxiety, fatigue, poor sleep and sleepiness. Data suggest that disparages in circadian phase might contribute to these problems. From an internal validity standpoint, first year medical students are an ideal group to study. The majority of the students will be matched on variables such as education, age, and intelligence. However, more importantly, they have a nearly identical life style when it comes to factors such as schedule, living conditions, level of stress, and timing of stressors. The specific aim and hypothesis is:Medical students randomized to sleep hygiene counseling plus simulated dawn will report less depression, anxiety, fatigue, sleepiness, and sleep disruption (as measured by standardized questionnaires) than students randomized to just sleep hygiene counseling.
Inclusion criteria: inclusion criteria:

 Being a first year medical student

 Good academic standing after the first module

 Reporting attending morning lectures regularly.

Exclusion criteria: :

 No reported history of psychiatric illness,sleep illness, ophthalmic illness

 No current use of photosensitizing medications

['Simulated Dawn Light Box', 'Sleep Hygiene instructions']

Simulated Dawn Light Box
Sleep Hygiene instructions

['Depression', 'Anxiety', 'Fatigue', 'Sleepiness', 'Sleep Disruption']

Depression
Anxiety
Fatigue
Sleepiness
Sleep Disruption


Spironolactone Administration to Prevent Ischemic Kidney Injury in Critically Ill Cancer Patients

Summary: Acute kidney injury frequently affects cancer patients. The main cause of acute kidney injury is ischemic damage caused by transient decrease in renal blood flow, followed by blood flow restoration and accompanying reperfusion injury (ischemia-reperfusion injury. Several studies, mainly in animal models have tried to establish spironolactone role on kidney injury induced by ischemia-reperfusion injury. It has been demonstrated in renal transplant recipients that the administration of spironolactone can prevent oxidative stress and is safe. The group of cancer patients with states capable of producing tissue hypoperfusion (hypovolemic shock, heart failure, major surgery, use of anesthetics) are at increased risk of developing acute renal ischemia-reperfusion injury.~The investigators hypothesis is that spironolactone may be useful in preventing acute renal injury when administered during the first six hour of renal ischemia-reperfusion insult.~The purpose of this study is to determine the utility of spironolactone administered after an ischemic renal insult (major surgery) to prevent acute kidney injury in critically cancer patients.~Investigators propose a pilot study, randomized, double blind, placebo controlled trial, approved by the local ethical committee, to compare the efficacy of spironolactone to prevent acute kidney injury in patients after major surgery. Investigators will include 12 patients in spironolactone group (25mg daily for three days) and 12 patients in placebo group.
Inclusion criteria: inclusion criteria:

 Patients admitted to the ICU in the immediate postoperative period (first 24 hours) of major surgery, defined as involving general anesthesia, ventilation, opening of large cavities (cranial, thoracic, abdominal).

 Patients with informed consent signed by them or their responsible relative.

 Patients who are likely to survive at least 48 hours after admission to the ICU.

 Patients who have measured baseline creatinine before UCI admission, in the last three months.

Exclusion criteria: :

 Patients who have contraindications for enteral medications.

 Patients who have acute kidney injury at the time of admission.

 Patients on renal replacement therapy prior to ICU admission.

 Patients with previous diagnosis of chronic kidney disease G3b stage.

 Patients with plasma potassium greater than 5.1mEq/L.

 Hypersensitivity to spironolactone.

 Septic shock.

 Obstructive uropathy.

 Renal transplantation.

 Postoperative period of nephrectomy.

 Pregnancy.

 Known adrenal insufficiency.

 Patients requiring a higher dose of norepinephrine 0.1mcg/kg/min for more than an hour to maintain mean arterial pressure equal to or greater than 70mmHg even after receiving fluid resuscitation.

 Patients requiring the administration of inhibitors of angiotensin-converting enzyme (ACE) for its management.

 Patients requiring an increase of 25% or more of the dose of norepinephrine to maintain mean arterial pressure equal of greater than 70mmHg during follow up.


Ultrasound and Videofluoroscopy for Diagnosing Swallowing Disorders

Summary: This study will identify clinical signs and symptoms critical for diagnosing swallowing disorders and will characterize swallowing problems in various patient populations, such as patients with Parkinson's disease, stroke, post-polio syndrome, multiple sclerosis and other conditions that cause swallowing abnormalities.~Patients with swallowing difficulties who are enrolled in NIH neurology or speech pathology protocols may be eligible for this study. Participants will undergo the following procedures:~Oral examination-A neurologist and speech pathologist examine the patient's swallowing function. The patient is interviewed about difficulties with food intake, chewing and swallowing during meals.~Ultrasound examination-Ultrasound creates image of areas inside the body using sound waves. With the patient in a sitting position, a 3/4-inch transducer (device for transmitting and receiving sound waves) is placed under the chin to visualize tongue movements during swallowing.~Modified barium swallow-While standing or sitting, the patient swallows 1/2 teaspoon of flavored barium (a radioactive substance) six times (a total of 3 teaspoons), while the tongue and pharynx (tube leading from the mouth to the esophagus) are scanned and videotaped. The barium is given in three consistencies-thin, medium and thick (pudding-like).~Electromyography-A small plastic strip with wires attached is placed under the patient's chin. The patient then swallows 1/2 ounce of barium three times in a row, and the movement of the chin muscles during swallowing is displayed. Patients may also be asked to swallow 5/8 cup of barium twice; once with the head tilted upward and once with the head untilted.~Depending on the test results, patients may be asked to return for follow-up study and monitoring.
Inclusion criteria: inclusion criteria:

 Any Clinical Center inpatients and outpatients with known or suspected dysphagia on any other NIH institute protocol can be included for study as well as patients who are admitted specifically for this protocol.

 Those patients at risk for oropharyngeal dysfunction will be screened initially by completing a self-assessment swallowing questionnaire, and by an interview with staff and/or family members. Patients who demonstrate appropriate signs and symptoms of dysphagia and oral motor impairment on the screening assessment will be considered for the protocol:

 Difficulty swallowing food or pills.

 Changed swallowing ability.

 Coughing or choking when eating.

 Shortness of breath during swallowing.

 Food backing up into the mouth or nasal passage.

 Fever or voice changes after swallowing.

 Pain when swallowing.

 Unexplained loss of weight.

Exclusion criteria: :

 Patients who are severely demented or severely compromised will be excluded if they do not have sufficient cognitive ability to follow directions.

 Patients who are non-ambulatory will be excluded if they can not be braced or supported within the fluoroscopy unit.

 Highly agitated individuals will also be excluded if they are unable to remain confined in the equipment.

 Infants and children under age 3 will be excluded due to radiation risk on the developing visual system.

['Deglutition Disorder', 'Motor Neuron Disease']

Deglutition Disorder
Motor Neuron Disease


A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults

Summary: This study compares the safety and immunogenicity profile of several travel vaccines given alone or concomitantly with MenACWY-CRM to healthy adults.
Inclusion criteria: inclusion criteria:

 Female and male subjects who must be healthy and must be:

 Between 18 and 60 years of age inclusive and who have given their written informed consent;

 Available for all visits and telephone calls scheduled for the study;

 In good health as determined by medical history, physical examination and clinical judgment of the investigator;

 For female subjects, having a negative urine pregnancy test.

Exclusion criteria: :

 Individuals not eligible to be enrolled in the study are those:

 who are breastfeeding;

 who have a personal history of Neisseria meningitidis infection, typhoid fever, rabies, or any flavivirus infection (e.g., Japanese encephalitis, tick-borne encephalitis, yellow fever, dengue fever, West Nile virus infection);

 who have been immunized with any of the study vaccines within the last five years as determined by medical history and/or vaccination card;

 who have received investigational agents or vaccines within 30 days prior to enrollment or who expect to receive an investigational agent or vaccine prior to completion of the study;

 who have received live licensed vaccines within 30 days and inactive vaccine within 15 days prior to enrollment or for whom receipt of a licensed vaccine is anticipated during the study period.

 (Exception: Influenza vaccine may be administered up to 15 days prior to each study immunization and no less than 15 days after each study immunization);

 who have received an anti-malaria drug, up to 2 months prior to the study;

 who have experienced, within the 7 days prior to enrollment, significant acute infection (for example requiring systemic antibiotic treatment or antiviral therapy) or have experienced fever (defined as body temperature ≥ 38°C) within 3 days prior to enrollment;

 who have any serious acute, chronic or progressive disease such as:

 history of cancer

 complicated diabetes mellitus

 advanced arteriosclerotic disease

 autoimmune disease

 HIV infection or AIDS

 blood dyscrasias

 congestive heart failure

 renal failure

 severe malnutrition (Note: Subjects with mild asthma are eligible for enrollment. Subjects with moderate or severe asthma requiring routine use of inhaled or systemic corticosteroids are not eligible for enrollment);

 who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome;

 who have a history of anaphylaxis, serious vaccine reactions, or allergy to any vaccine component, including but not limited to latex allergy, egg allergy, antibiotic allergy, chicken proteins or gelatin allergy;

 who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):

 receipt of immunosuppressive therapy within 30 days prior to enrollment (systemic corticosteroids administered for more than 5 days, or in a daily dose > 1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy);

 receipt of immunostimulants;

 receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study;

 who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;

 who have myasthenia gravis; thyroid or thymic disorders,

 who have any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives;

 who are part of the study personnel or close family members of those conducting this study.

 for whom a long-term stay (≥ 1 month) was planned in Africa, Latin America, or Asia.

['Typhoid Vi Polysaccharide Vaccine', 'Yellow Fever Vaccine', 'Japanese Encephalitis Vaccine', 'Rabies Vaccine', 'MenACWY-CRM Vaccine']

Typhoid Vi Polysaccharide Vaccine
Yellow Fever Vaccine
Japanese Encephalitis Vaccine
Rabies Vaccine
MenACWY-CRM Vaccine

['Meningococcal Disease', 'Meningococcal Meningitis', 'Typhoid', 'Yellow Fever', 'Rabies', 'Japanese Encephalitis']

Meningococcal Disease
Meningococcal Meningitis
Typhoid
Yellow Fever
Rabies
Japanese Encephalitis


Fondaparinux as Monotherapy for DVT and/or Pulmonary Embolism

Summary: To determine whether fondaparinux as monotherapy without warfarin is effective and safe for long-term (90 days) treatment of DVT and/or PE, thus gaining new long-term experience and data using fondaparinux.
Inclusion criteria: inclusion criteria:

 Recurrent venous thromboembolism despite anticoagulation with warfarin(Or)

 Clinically important bleeding complications due to warfarin(Or)

 Inability to achieve the target INR on warfarin(Or)

 Nonbleeding side effects of warfarin, such as hair loss, rash, purple toe syndrome(Or)

 Patient with cancer on monotherapy with parenteral anticoagulation for DVT and/ or PE

 and

 Require at least 90 days of anticoagulation

 Require anticoagulation for objectively confirmed DVT and/or PE

 Age greater than 18 years

 Written informed consent

Exclusion criteria: :

 Patients with renal insufficiency, defined as creatinine > 1.5 mg/dl

 Patients in whom anticoagulation with any agent is deemed unsafe due to bleeding risk.

 Pregnancy

 Known hypersensitivity to fondaparinux

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


A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers

Summary: Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of aspirin-related peptic ulcers.
Inclusion criteria: inclusion criteria:

 aspirin users who have a peptic ulcer confirmed by endoscopy

Exclusion criteria: :

 serious medical illness (including cardiovascular events within 6 months before endoscopy)

 acute gastrointestinal bleeding

 a history of gastric or duodenal surgery

 allergic to the study drugs

 require long-term treatment with non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, or anticoagulant agents

 pregnancy


Development and Evaluation of Modified Yoga in Systemic Lupus Erythematosus (SLE)

Summary: The purpose of this study is to test the effects of a modified yoga program in persons with SLE.
Inclusion criteria: inclusion criteria:

 age 18-65

 Diagnosis of SLE based on ACR criteria

Exclusion criteria: :

 presently enrolled in a yoga program

 osteoporosis (T score ≥ -2.5)

 avascular necrosis

 taking quinolone in the preceding 3 months

 taking ≥ 30 mg of prednisone daily

 history of joint replacement or organ transplant

 Persons with any pre-existing condition that would prevent attendance at the yoga classes


Effect of Timing of Umbilical Cord Clamping on Anaemia at 8 and 12 Months and Later Neurodevelopment

Summary: The investigators plan a study to randomize 540 children in Nepal to early (≤30 seconds) or late (≥180 seconds) clamping of the umbilical cord at birth. The children will be followed with blood tests (hemoglobin and ferritin) at 8 and 12 months of age, and their development is evaluated by questionnaire (Ages & Stages Questionnaire ) at 12 months of age, and by testing (Bayley -III) at 18-24 months of age. By implementing the project in a country with a high proportion of anemia at one year of age (about 75%), we can reduce the number of children in the study and still achieve significant results.~Iron deficiency is a global health problem and causes anemia and impaired neurodevelopment in children. Anemia is estimated by WHO to occur among 25% of all children before school age, and the corresponding figure in Europe is 3-9 %.~By waiting 3 minutes to clamp the cord after birth, a large part of the child's blood volume remaining in the placenta is transfused over to the child's body. Research shows that the neonate's blood volume can increase by about 40% and this blood contains 3 to 4 months' supply of iron. In Sweden, we have shown that late clamping of the umbilical cord could reduce iron deficiency in children at four months of age by 90%. Globally, most countries practice early cord clamping and the child is deprived of the placental blood transfusion. The hypothesis of the study is that by delaying the clamping of the umbilical cord, anemia at 8 and 12 months will be reduced an this in turn will be beneficial for the childrens development.~The project will be implemented at Paropakar Maternity and Women 's Hospital, Kathmandu. It hosts approximately 23,000 births annually.
Inclusion criteria: inclusion criteria:

 Late preterm or term pregnancy (gestational age 34 to 41 weeks)

 Vaginal delivery

Exclusion criteria: :

 Serious congenital malformation, syndrome or other congenital disease that can affect the outcome measures

['Early (≤30 seconds) cord clamping', 'Delayed (≤180 seconds) cord clamping']

Early (≤30 seconds) cord clamping
Delayed (≤180 seconds) cord clamping

['Anemia', 'Iron Deficiency', 'Neonatal Jaundice']

Anemia
Iron Deficiency
Neonatal Jaundice


Characterization of Skeletal Muscle Using Magnetic Resonance Elastography (MRE)

Summary: The goal of this proposal is two-fold: (1) to further develop and validate a technology, magnetic resonance elastography (MRE), for quantitatively imaging mechanical properties and tension distribution in muscle and (2) to apply the technique for in vivo evaluation of patients with four common, and clinically significant muscle disorders (spasticity, disuse atrophy, myofascial pain and a metabolic myopathy). These studies will employ a magnetic resonance imaging sequence with synchronous motion-sensitizing gradients to map propagating shear waves in the muscle. The technique will assess the mechanical properties of the muscle and its tension distribution. Specifically, the study can be divided into three specific aims. Aim 1: Optimize MRE methods of acquisition and analysis for the assessment of muscle, including electromechanical drivers, data acquisition techniques, and methods for image analysis. Advanced techniques for very rapid MRE assessment of muscle will continue to be developed. Aim 2: Validate the MRE assessment of muscle properties and tension with phantom, ex-vivo muscle, and Finite Element Modeling (FEM) techniques. Finite Element Analysis will be performed by using both phantom and bovine muscles to better correlate MRE wave-length findings as function of muscle properties, tension and fiber architecture. Aim 3: Study In Vivo Normal and Abnormal Muscle. The MRE technique will be applied in vivo to provide elastographic images of abnormal muscle with known disorders. The patient groups chosen for study are each important in their own right, and furnish unique information across the spectrum of muscular disease and dysfunction. Groups to be studied include individuals with new onset of spasticity following an ischemic, hemispheric stroke, disuse atrophy as a result of immobilization, metabolic (hyperthyroid) myopathy and myofascial pain for trigger point identification. The overall hypothesis of this work is that will bring benefits to both basic research and clinical care.
Inclusion criteria: inclusion criteria:

 Normals:

 Healthy individuals

 Stroke:

 a first stroke (i.e., a unilateral, ischemic hemispheric stroke) within the previous one to two months, ability to cooperate and follow simple commands, and gastrocsoleous strength in the affected lower extremity of between trace and 50% of normal.

 Immobilization:

 immobilized in a cast (typically 6 weeks) following sugical repair of a severe Achilles tendon tear or rupture, ankle injury or plantar fascial pain

 Myofascial Pain:

 history of pain in trapezius confirmed by clincal examination. The examiner will perform snapping palpation over the MFTP. If a localized, transient contraction is observed, the response is considered to be positive and the subject will be considered eligible for entry into the study.

 Hyperthyroid Myopathy:

 clinical assessment in combination with a serum hormone profile of increased Free Thyroxine (FT4) and Triiodothyronine (T3) in the face of suppressed levels of Thyroid Stimulating Hormone (TSH).
Exclusion criteria:

['Stroke', 'Immobilization', 'Myofacial Pain', 'Hyperthyroid Myopathy']

Stroke
Immobilization
Myofacial Pain
Hyperthyroid Myopathy


Renal Artery Calcium and Hypertension

Summary: CT of the abdomen is a very common examination performed for various indications.One of the common findings is vascular calcifications including calcifications of the renal arteries.Calcifications in the carotid arteries and coronary arteries are good predictor for obstructive atherosclerotic disease.Stenosis of the renal arteries can cause symptomatic or asymptomatic hypertension with subsequent clinical sequelae. Therefore early diagnosis of this condition is imperative.~The goal of our study is to investigate the correlation between incidental calcifications of the renal arteries in CT examinations and the presence of actual stenosis of these vessels in patients with and without hypertension.
Inclusion criteria: inclusion criteria:

 Every patient referred fo abdominal CT aged 30-100

Exclusion criteria: :

 Contraindication for IV contrast injection failure to demonstrate renal arteries with contrast refusal to sign an informed consent


A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease

Summary: Determine the predictive value of CARDIOLITE® rest and stress myocardial perfusion imaging (MPI) to define a pediatric population with Kawasaki Disease (KD) at high and low risk of developing cardiac events.
Inclusion criteria: inclusion criteria:

 Males or females between 4 and 16

 Meet the epidemiological definition of Kawasaki Disease or have a diagnosis of incomplete KD, including evidence of coronary artery disease as determined by their physician.

 Be able to exercise adequately to achieve 85% age predicted maximum heart rate

Exclusion criteria: :

 Terminal illness where expected survival is < 6 months


Gore Tex Implants in the Treatment of Atrophic Rhinitis

Summary: This is a retrospective study, involving patients with atrophic rhinitis, that underwent Gore tex® implants in the nasal fossa.~The Fetid Rhinitis or Atrophic Ozena is a chronic illness characterized by yellowish secretion in the initial phase and the other phases with fetid crusts and atrophy of the mucous bone covering. Diverse theories exist that try to explain the appearance of this pathology, such as: hereditary factors, immunological alterations, viral infection and nutritional lack. Currently, its etiology remains unknown. As there isn't any ideal treatment already established, this technique improves the options of treatment.~All patients have improved after the procedure.
Inclusion criteria: inclusion criteria:

 Symptoms of atrophic rhinitis, with previous clinical treatment without good results

Exclusion criteria: :

 Patients with mental illness

['implants of polytetrafluoroethylene in tha nasal fossa']