Pilot Study to Evaluate the Efficacy and Safety of Quetiapine Fumarate Instant-Release (Seroquel IR) in Controlling Agitation and Aggressive Symptoms in the Acute Treatment of Patients With Schizophrenia

Summary: Quetiapine fumarate is indicated for the treatment of patients with schizophrenia in China. Lots of clinical experience and evidence has demonstrated its efficacy and tolerability for the patient population. Some evidence showed that quetiapine fumarate could control aggression and agitation within 1 week, which is appropriate for the acute treatment of patients with schizophrenia. PANSS and MOAS are the common measurements for the efficacy of psychotic symptoms controlling in the clinical trials. Generally, 2 weeks are the appropriate timeframe for the evaluation of clinical effect of agitation and aggression symptoms controlling.~In adult patients with schizophrenia, quetiapine fumarate is licensed to maximal dose of 750mg/day. The target dose of quetiapine fumarate recommended in the manufacturer's prescribing information is 300-450 mg/day in China, though similar efficacy for quetiapine fumarate (600 mg/day), olanzapine (15 mg/day) and Risperidone (5 mg/day) was reported in a small, randomised, rater-blinded trial. Because of the low incidence of EPS, the limitation potential for weight gain and prolactin elevation, quetiapine fumarate should be well tolerated in this sensitive patient population with higher dose (600mg/day-750mg/day) (Peuskens 2004).~The aim of the present study is to evaluate the efficacy and safety of quetiapine fumarate with daily dose 600-750mg/day in improving agitation and aggression for the treatment of Chinese acute schizophrenic patients hospitalised for acute phase over a treatment period of 2 weeks
Inclusion criteria: inclusion criteria:

 Provision of written informed consent by both patient and legal representative

 A diagnosis of schizophrenia by Chinese Classification and Diagnostic Criteria of Mental Disorder, 3rd version (CCMD-3)

 Male or female, aged 18 to 65 years

 MOAS total score ³ 10 at both screening and randomization

 Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment

 Able to understand and comply with the requirements of the study

Exclusion criteria: :

 Pregnancy or lactation

 Any CCMD-3 not defined in the inclusion criteria

 Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others

 Known intolerance or lack of response to quetiapine fumarate or haloperidol, as judged by the investigator

 Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir

 Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids

 Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation

 Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by CCMD-3 criteria

 Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by CCMD-3 criteria within 4 weeks prior to enrolment

 Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment

 Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator

 Involvement in the planning and conduct of the study

 Previous enrolment or randomisation of treatment in the present study.

 Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements

 A patient with Diabetes Mellitus (DM)

 An absolute neutrophil count (ANC) of £ 1.5 x 109 per liter

 2 times higher than the normal upper limit of ALT or AST.

 Use of clozapine within 28 days prior to randomisation


China Case Control Avian Influenza

Summary: This study will determine risk factors of human infection with avian influenza A virus, also known as bird flu virus. Certain risk factors such as exposure to poultry, travel history, health status, and other factors may affect one's risk of getting bird flu. Study participants will include individuals, older than age 1, that tested positive for influenza A (H5N1) in a previous surveillance program and controls (individuals that have not tested positive for avian influenza A (H5N1) and have no fever or respiratory symptoms). There will be 1 study visit during which volunteers will be asked detailed questions about their health, work, and travel habits. Study participants will be asked to donate a blood sample to test for antibodies, the part of the blood that fights infection.
Inclusion criteria: inclusion criteria:

 Participants should be informed and assent to participate in this study. For children, informed consent should be provided by their parents or legal guardians. Children aged from 10 years old to 18 years old will be asked to assent.

 Adults or children older than 1 year old.

 Satisfying above definition of cases and controls

Exclusion criteria: :

 Infants younger than 12 months

 For any cases or controls who need proxy, they should be excluded under below situations:

 Proxy can not provide sufficient information for this study, or

 Proxy refuses to participate in this study, or

 No suitable proxy can be found.


RNActive® Rabies Vaccine (CV7201) in Healthy Adults

Summary: The purpose of this trial is to assess the safety and immunogenicity of an investigational RNActive® rabies vaccine (CV7201) in healthy adults.
Inclusion criteria: inclusion criteria:

 Healthy male and female volunteers aged 18 to 40 years inclusive

 Compliant with protocol procedures and available for clinical follow-up through the last planned visit (V9)

 Physical examination and laboratory results without clinically significant findings

 Body Mass Index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2

 Females: Negative human chorionic gonadotropin (HCG) pregnancy test (serum) for women presumed to be of reproductive potential on the day of enrolment

 Females of childbearing potential must use acceptable methods of birth control during the trial and Follow-up period (from 6 weeks before the first administration of the test vaccine for the duration of the trial i.e., until the last planned visit (V9)). The following methods of birth control are acceptable when used consistently and correctly: established use of oral, injected or implanted hormonal methods of contraception; intrauterine devices (IUDs) or intrauterine systems (IUSs) with the exception of steel or copper wire; barrier methods of contraception (condom or occlusive cap [diaphragm or cervical/vault caps] with spermicidal foam/gel/film/cream/suppository); true abstinence (periodic abstinence [e.g., calendar, ovulation, symptothermal and postovulation methods] and withdrawal are not acceptable).

 Males must use reliable forms of contraception (barrier method with spermicidal agent or true abstinence) and must refrain from sperm donation during the trial and Follow-up period i.e., until the last planned visit (V9).

Exclusion criteria: :

 Use of any investigational or non-registered product (drug or vaccine) other than the trial vaccine within 4 weeks preceding the administration of the trial vaccine, or planned use during the trial period

 Subject has received any other licensed vaccines within 4 weeks prior to the administration of the trial vaccine

 Subject has received any investigational or licensed rabies vaccine previously

 Intending to travel to regions/countries for which rabies vaccinations are recommended or where high risk of infections exists according to travel recommendations by the German Society of Tropical Medicine and International Health (DTG) during the trial and up to V9 (Day 91/120) Follow-up

 Any treatment with immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the trial vaccine. The use of inhaled and nasal steroids, as well as topical steroids outside the vaccination area, will be permitted

 Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination

 History of autoimmune disease

 Administration of immunoglobulins (Igs) and/or any blood products within the 3 months preceding the administration of the trial vaccine

 Subject is taking chloroquine for malaria treatment or prophylaxis

 Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness or fever ≥ 38 °C measured orally

 Presence or evidence of significant acute or chronic, uncontrolled medical or psychiatric illness (subjects with uncomplicated chronic diagnoses stable and treated for ≥ 3 months e.g., mild hypertension well-controlled with medication, may be enrolled - provided the condition and its therapy are known not to be associated with an immunocompromised state or an autoimmune disease

 Major congenital defects

 Known allergy to any component of the trial product i.e., protamine. This includes subjects with allergy to fish protein, diabetics with allergy to protamine-containing insulin, or post-vasectomy males

 Known type I allergy to beta lactam antibiotics

 Evidence of current alcohol or drug abuse

 History of any neurological disorders or seizures, with the exception of febrile seizures during childhood

 Seropositivity for human immunodeficiency virus (HIV), hepatitis B virus (HBV) (except in subjects previously vaccinated against HBV) or hepatitis C virus (HCV)

 Foreseeable non-compliance with protocol as judged by the Investigator

 For females: Pregnancy or lactation

 History of any life-threatening anaphylactic reactions.

 Subjects with impaired coagulation in whom an IM injection is contraindicated.


Single IV Administration of TB-402 for Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery

Summary: The purpose of this study is to evaluate the safety and efficacy of two doses of TB-402 administered as a single intravenous infusion for the prevention of VTE in subjects undergoing total hip replacement surgery.
Inclusion criteria: inclusion criteria:

 Male or female subjects aged ≥ 18 years.

 Written informed consent.

 Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures

Exclusion criteria: :

 Pregnancy at the time of screening.

 Indication for anticoagulation other than post-operative thromboprophylaxis.

 Active bleeding or high risk of bleeding.

 Anticipated continued use of neuraxial catheter after surgery.

 Clinical laboratory findings at screening of thrombocytopenia or prolonged aPTT or PT.

 Uncontrolled hypertension.

 Impaired liver function (transaminase >3 X ULN) or history of hepatic insufficiency.

 Creatinine clearance <30 mL/min.

 Antiplatelet agents other than low dose aspirin (< 200mg).

 The use of intermittent pneumatic compression.

 Known hypersensitivity to contrast media or rivaroxaban.

 Known drug or alcohol abuse.

 Active malignant disease or current cytostatic treatment.

 Stroke within the previous month.

 Participation in an investigational drug study within the past 30 days or previous participation in this study.

 Any condition that in the opinion of the investigator would put the subject at increased risk from participating in the study or expected inability to comply with the protocol.

['Prophylaxis of Venous Thromboembolic Events']


Clinical Trials to Reduce the Risk of Antimicrobial Resistance

Summary: The primary objective of this study is to demonstrate a low rate of emergence of antibiotic resistance in P. aeruginosa and Acinetobacter spp during the treatment of hospitalized patients with pneumonia requiring mechanical ventilation treated with PD optimized meropenem administered as a prolonged infusion in combination with a parenteral aminoglycoside plus tobramycin by inhalation (Group 1) compared to therapy with meropenem alone (Group 2 - control arm).
Inclusion criteria: inclusion criteria:

 Written informed consent by the subject/subject's LAR.

 Hospitalized males or females ≥ 18 yrs with respiratory failure requiring mechanical ventilation and clinical suspicion of HABP, HCAP or VABP.

 Onset or exacerbation of pneumonia at least 48 hours after admission to any patient health care facility or onset of pneumonia in a nursing home or rehabilitation facility with subsequent transfer to an acute care facility

 Women of childbearing potential if their pregnancy test is negative

 Subjects who have received previous antibacterial therapy within 14 days of pre-treatment bronchoscopy entry may be entered only if the subject has not responded clinically.). While less than 24 hours of pre-treatment antibiotics is preferential, recovery of >104 CFU/ml in the quantitative Bronchoscopic BAL will be seen as primary evidence that the prior therapy was not efficacious and enrollment will be allowed.)

 Patients should have clinical findings that support a diagnosis of HABP/VABP/HCAP:

 Within 48 hours before starting empiric therapy a subject's chest radiograph should show the presence of a NEW or progressive infiltrate, cavitation, or effusion suggestive of pneumonia

 Within 36 hours before the start of empiric study therapy, a quantitative culture of Bronchoscopic BAL fluid must be obtained.

 Patients with VABP should have a Clinical Pulmonary Infection Score of >/= 5.

Exclusion criteria: :

 Subjects with pneumonia caused by pathogens resistant to meropenem (MIC greater than or equal to 16µg/ml) or a prior meropenem therapy failure.

 Subjects with contra-indications to ANY study medication, in particular with known or suspected allergy or hypersensitivity.

 Women who are pregnant or lactating.

 Subjects taking anticonvulsant medications for a known seizure disorder.Patients with a history of seizures, AND who are stabilized on anti-seizure medication, may be enrolled into the study at the discretion of the site investigator.

 Subjects with known or suspected community acquired bacterial pneumonia (CABP) or viral pneumonia; or Subjects with acute exacerbation of chronic bronchitis without evidence of pneumonia.

 Subjects with primary lung cancer or another malignancy metastatic to the lungs.

 Subjects who were previously enrolled in this study.

 Subjects who have had an investigational drug or have used an investigational device within 30 days prior to entering the study.

 Subjects with another focus of infection requiring concurrent antibiotics that would interfere with evaluation of the response to study drug.

 Subjects with cystic fibrosis, AIDS with a CD4 lymphocyte count <200 cells/µl, neutropenia (absolute neutrophil count <500 cells/ml), known or suspected active tuberculosis.

 Subjects with little chance of survival for the duration of study therapy.

 Subjects with an APACHE II score >35.

 Subjects with underlying condition(s) which would make it difficult to interpret response to the study drugs.

 Subjects with hypotension or acidosis despite attempts at fluid resuscitation. Subjects requiring ongoing treatment with vasopressors will be eligible for the study if their hypotension is controlled and acidosis has resolved. Subjects with intractable septic shock are not eligible for enrollment.

 Subjects who have undergone bone marrow transplantation.

 Subjects with profound hypoxia as defined by a PaO2/FiO2 ratio <100.

['IV meropenem', 'I.V. Meropenem', 'Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h', 'Linezolid or Vancomycin (per institutional guidelines) will be available for MRSA coverage.', 'tobramycin nebulization']


Avian Influenza Studies In Lebanon

Summary: The highly pathogenic avian influenza (HPAI) H5N1 virus arrived in the Middle East in 2005 and has since established itself in local domestic birds and is now considered endemic in several Middle Eastern countries.Few studies indicate the presence of low pathogenicity avian influenza (LPAI) viruses of the H9 type among Lebanese poultry and wild birds. These studies also provide some evidence suggesting that humans exposed to these sick birds are showing elevated antibody titers against these LPAI H9 viruses.~This study will focus on the following objectives:~To determine the seroprevalence of AI in poultry-exposed and non-exposed human populations.~To identify risk factors associated with AI infections in occupationally-exposed poultry workers.~To conduct nation-wide cross-sectional surveillance for AI viruses among domestic birds in low biosecurity farms and backyard flocks.
Inclusion criteria: inclusion criteria:

 Be at least 18 years old.

 Be willing to participate by signing a consent form, completing the study questionnaire, and providing a blood sample.

Exclusion criteria: :

 Less than 18 years old.

 Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy. (Note that we have chosen to exclude such populations because of their increased risk of acquiring infections, they are relatively few, and are not representative of a national sample).

 Any individual with unknown poultry exposure status, or who was exposed to poultry more than 5 years ago.


Evaluation of a Neck Strengthening Program to Reduce the Risk of Sport-related Concussion

Summary: Evaluation of a neck strengthening program as a potential intervention to reduce the risk of sport-related concussion in youth contact and collision sport athletes.
Inclusion criteria: inclusion criteria:

 Contact/collision sport athletes (for example, american football, soccer, rugby, lacrosse, ice hockey, field hockey, basketball, wrestling, boxing, martial arts, water polo)

Exclusion criteria: :

 History of concussion (suspected or diagnosed) in the previous 6 months

 History of neck pain or injury in the previous 6 months

 History of migraine headaches

 History of personal or parental history of a diagnosed anxiety disorder

['Sport-related Concussion', 'Brain Concussion', 'Healthy']

Sport-related Concussion
Brain Concussion
Healthy


Carcinogenicity Study of Bupropion

Summary: There is a lack of toxicology data on one bupropion metabolite, and limited literature examining bupropion use and cancer risk. This study evaluates the association between bupropion exposure and the development of cancer of the prostate, breast, lung, colon/rectum, urinary bladder, and uterus by comparing the risk of cancer in bupropion users with other antidepressant users. Because there is no evidence that bupropion is associated with any particular cancer, we have chosen the six most common cancers diagnosed in the United States to optimize statistical power/precision for cancer-site specific comparisons. Two US population-based data resources with automated claims, pharmacy, and tumor registry data are included in this study. Using a nested case-control design, this study will compare the incidence of cancer in patients exposed to bupropion with the incidence in patients exposed to other antidepressants.
Inclusion criteria: inclusion criteria:

 -

Exclusion criteria: :

 Cancers diagnosed within 12 months of initiation (i.e., new use) of antidepressant pharmacotherapy will be excluded to account for a minimum period for the development of cancer (cancer latency) and to be consistent with other studies of antidepressants and cancer.

 Patients with a history of any cancer (cancer diagnosis recorded in the tumor registries anytime before the first antidepressant prescription recorded during the study period)

 Any antidepressant use within 6 months of January 1, 1996

['Regular bupropion use', 'Regular SSRI (Selective serotonin reuptake inhibitors) use', 'Regular TCA (Tricyclic antidepressants) use', 'Regular use of any other antidepressant']


Incidence of Metabolic Syndrome and Thyroid Dysfunction in Patients With Major Depressive Disorder

Summary: Aim 1 is to study prevalence and 1 year incidence of metabolic syndrome in major depressive disorder and factors correlation.~Aim 2 is to study prevalence and 1 year incidence of thyroid dysfunction in major depressive disorder and factors correlation.
Inclusion criteria: inclusion criteria:

 patient with major depressive disorder

 age over 18 years

Exclusion criteria: :

 subject who cannot give information.

['Major Depressive Disorder', 'Metabolic Syndrome', 'Thyroid Dysfunction']

Major Depressive Disorder
Metabolic Syndrome
Thyroid Dysfunction

:

 subject who cannot give information.


Stepwise Shock Wave Lithotripsy in Pediatric Urolithiasis

Summary: To evaluate and compare the results of conventional and stepwise shock wave lithotripsy treatment modalities in pediatric urinary lithiasis.
Inclusion criteria: inclusion criteria:

 The patients with pediatric urinary lithiasis.

Exclusion criteria: :

 Resistant urinary tract infections Coagulopathies Anatomically obstructed urinary system


Effect of Panax Ginseng on the Cognitive Performance in Alzheimer's Disease

Summary: We investigate the clinical efficacy of Panax ginseng in Alzheimer's disease (AD).
Inclusion criteria: inclusion criteria:

 Alzheimer's disease

Exclusion criteria: :

 other neurologic disease

["Alzheimer's Disease", 'Memory Decline']

inclusion criteria:

 Alzheimer's disease


A Non-drug Study Profiling Cutaneous Lupus

Summary: The purpose of this study is to characterize the clinical and molecular profiles of patients with cutaneous lupus.
Inclusion criteria: inclusion criteria:

 have active DLE or active SCLE confirmed by histological analysis

 have a confirmed diagnosis of SLE with SLE Disease Activity Index (SLEDAI) of >6 and current or historical positive ANA or anti-dsDNA

 have an active skin lesion that can be biopsied

 if using hydroxychloroquine or chloroquine, must be on stable doses for at least 2 months prior to screening.

Exclusion criteria: :

 have an active skin disease other than CLE

 have any known malignancy within the previous 5 years (with the exception of a non-melanoma skin cancer that has been treated with no evidence of recurrence)

 have used a topical corticosteroid on active lesion

 have donated blood (volume >=500 mL) within 56 days prior to screening

 has been treated with drugs that are associated with CLE induction within 2 months prior to the screening

 have been treated with >10 mg/day prednisone therapy or equivalent in the last 4 weeks prior to screening.

['No intervention, skin biopsy', 'No intervention, blood collection', 'No intervention, urine collection']

No intervention
skin biopsy
No intervention
blood collection
No intervention
urine collection

['Lupus Erythematosus, Cutaneous', 'Lupus Erythematosus, Systemic', 'Lupus Erythematosus, Discoid']

Lupus Erythematosus
Cutaneous
Lupus Erythematosus
Systemic
Lupus Erythematosus
Discoid


Early Detection of Lung Tumors by Sniffer Dogs - Evaluation of Sensitivity and Specificity

Summary: Some groups reported that sniffer dogs can be applied to detect lung cancer in the exhaled breath of patients. Therefore, breath samples (BS) of patients are collected. Five sniffer dogs are trained to distinguish between the BS of patients with lung cancer and healthy individuals (controls). In a prospective, randomized blinded study the dog's ability to differentiate between BS of i) patients with lung cancer, ii) patients with inflammatory airway disease, but no evidence of cancer and iii) healthy individuals is tested.
Inclusion criteria: inclusion criteria:

 age 18-80

 competent

 confirmed lung cancer

Exclusion criteria: :

 history of other cancers

['exhalation analysis of breath sample', 'exhalation analysis of breath sample', 'exhalation analysis of breath sample']

exhalation analysis of breath sample
exhalation analysis of breath sample
exhalation analysis of breath sample

['Lung Cancer', 'Chronic Obstructive Airway Disease']

Lung Cancer
Chronic Obstructive Airway Disease


Screening DIVA - Diffuse Vascular Disease

Summary: Primary Objective:~To investigate the value of the Edinburgh Claudication Questionnaire (ECQ) against the ankle-brachial index (ABI) in Canadian patients mainly followed in general practice, with documented acute coronary syndrome (ACS)/ischemic stroke (IS)/transient ischemic attack (TIA) and who are not known to have peripheral arterial disease (PAD) at the time of enrolment.~Secondary Objective:~To collect data on the prevalence of PAD in this population as measured by ABI.
Inclusion criteria: inclusion criteria:

 Documented acute coronary syndrome (Unstable angina, non-Q-wave myocardial infarction, Q-wave myocardial infarction) or/and documented ischemic stroke/transient ischemic attack (IS/TIA)

Exclusion criteria: :

 Previously known symptomatic or asymptomatic PAD confirmed by one of the following diagnostic methods or interventions (documented in the patient's medical record):

 Non-invasive or invasive vascular diagnostic tools (e.g.: ABI, Toe-brachial index, Duplex ultrasound, Magnetic resonance angiography, Computer tomographic angiography, Contrast angiography)

 Previous related intervention (such as angioplasty, stenting, atherectomy, peripheral arterial bypass graft, other vascular intervention including amputation)

 Patients whose ABI cannot be measured accurately

 Patients already in a clinical trial or a product registry

 Hospitalized patients

 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Atacicept Demonstrating Dose RESponSe

Summary: Systemic lupus erythematosis (SLE) is an autoimmune disease, meaning that the body's immune system attacks its own organs and tissues. Within the immune system, B-cells and plasma cells make proteins called antibodies, which in autoimmune disease can bind to one's own tissues and are thus referred to as autoantibodies. Atacicept blocks 2 factors in the body, called BLyS and APRIL, which are important for the maintenance of B-cells and plasma cells, and thus the production of antibodies. This study will assess whether treatment with atacicept can reduce SLE disease activity. Atacicept is still an experimental drug, meaning that it is not available outside of a clinical trial, and that its potential benefits and risks have not been fully determined.~A total of 175 subjects are planned to be randomized (35 subjects per treatment arm) in a 1:1:1:1:1 ratio to receive either atacicept 5 mg, atacicept 25 mg, atacicept 75 mg, atacicept 115 mg or matching placebo, given subcutaneously once weekly for 24 weeks.~The primary objective of the trial is to evaluate the efficacy of atacicept compared to placebo in reducing SLE disease activity in subjects treated with standard of care (SoC) therapy and to investigate the dose-response relationship.~The secondary objectives of the trial are:~To evaluate the effect of atacicept in reducing corticosteroid usage~To evaluate the safety and tolerability profile of atacicept in subjects with SLE~To confirm the PK and PD profiles of atacicept in SLE subjects~To evaluate the changes in the Medical Outcomes Study Short Form General Health Survey [SF-36].
Inclusion criteria: inclusion criteria:

 Male or female of ≥18 years of age

 Written informed consent

 Diagnosis of SLE satisfying at least 4 out of the 11 ACR criteria during the course of their illness

 Disease duration of at least 6 months

 SLEDAI-2K score ≥ 6 at screening

 Positive test results for antinuclear antibody (ANA) (HEp-2 ANA ≥1:80) and/or anti-double-stranded deoxyribonucleic acid (dsDNA) (≥30 IU/mL) at screening

 Negative serum pregnancy test and highly effective method of contraception for woman of childbearing potential.

Exclusion criteria: :

 Increase in dosing of corticosteroids within 2 weeks prior to screening

 Introduction of MMF within 3 months prior to TD1 or increase in dosing within 1 month before screening

 Change in dosing of immunosuppressants or corticosteroids during the screening period

 Serum IgG < 6g/L

 Estimated Glomerular Filtration Rate (GFR) <50 mL/min/1.73m²

 Urinary protein:creatinine ratio >2 mg/mg

 History of demyelinating disease

 Breastfeeding or pregnancy

 Legal or limited legal capacity

 Additional

['Placebo', 'Atacicept', 'Atacicept', 'Atacicept', 'Atacicept']

Placebo Atacicept Atacicept Atacicept Atacicept


Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults

Summary: The goal of the study is to assess the role of cholinesterase inhibitors in affecting the driving ability of cognitively intact seniors using driving simulators. We hypothesize that the use of a cholinesterase inhibitor for two weeks will be associated with improvement in safe driving behavior on a simulated driving task.
Inclusion criteria: inclusion criteria:

 valid Ontario driver's license

 active driver (greater than or equal to three times per week)

 written, informed consent

 lives in Toronto/Thunder Bay

 healthy

 Male between 65-75 years old

Exclusion criteria: :

 cognitive impairment

 psychiatric history

 sleep disorder history

 substance abuse

 neurological history

 medical illness

 ophthalmological disease

 psychoactive medications

 contra-indications to Donepezil

 experience car/motion sickness


Continuous Infusion Piperacillin-tazobactam for the Treatment of Cystic Fibrosis

Summary: Cystic fibrosis is an inherited disorder leading to chronic pulmonary inflammation and infection. A majority of people with cystic fibrosis have large quantities of bacteria residing in their lungs. One of the most common and harmful bacteria is called Pseudomonas aeruginosa.~Patients with cystic fibrosis require frequent therapy with intravenous (I.V.) antibiotics to treat lung infections thought to be caused by Pseudomonas aeruginosa. One of the antibiotics frequently used to treat this bacteria is piperacillin-tazobactam. Piperacillin-tazobactam is thought to be the most effective when there is a constant level of drug in the body. The standard way to administer piperacillin-tazobactam is to give several grams 4 times each day as a 30 minute infusion. An alternative way to give piperacillin-tazobactam is by a continuous infusion; a continuous infusion will make it more likely that drug will remain at a constant level in the body. The objective of this study is to determine if administering piperacillin-tazobactam as a continuous infusion is more effective at treating people having a pulmonary exacerbation of cystic fibrosis than a standard 30 minute infusion, 4 times a day.
Inclusion criteria: inclusion criteria:

 Diagnosis of cystic fibrosis

 8 years of age or greater

 Chronic or intermittent infection with Pseudomonas aeruginosa as defined by the Leeds Criteria

 Pulmonary exacerbation as defined by Fuchs et al.

Exclusion criteria: :

 Admission for greater than 48 hours prior to enrollment

 Isolation of Burkholderia spp. in a respiratory tract culture in the prior 12 months

 Current treatment for allergic bronchopulmonary aspergillosis

 Pregnant or breast feeding

 History of solid organ transplantation

 Renal impairment at time of randomization (< 40 mL/min as calculated by the Cockcroft-Gault equation24 ¬for adults or the Schwartz equation45 for those < 18 years of age) or receipt of hemodialysis

 Allergy to study medication


Pancreas Resection With and Without Drains

Summary: This randomized prospective trial is designed to test the hypothesis that pancreatectomy without routine intraperitoneal drainage does not increase the severity or frequency of complications within 60 days of surgery.
Inclusion criteria: inclusion criteria:

 The subject has a surgical indication for distal pancreatectomy.

 In the opinion of the surgeon, the subject has no medical contraindications to pancreatectomy.

 At least 18 years of age.

 The subject is willing to consent to randomization to the intraperitoneal drain vs. no drain group.

 The subject is willing to comply with 90-day follow-up and answer quality-of-life questionnaires per protocol.

Exclusion criteria: :

 The subject does not have a surgical indication for distal pancreatectomy.

 In the opinion of the surgeon, the subject has medical contraindications to pancreatectomy.

 Less than 18 years of age.

 The subject is not willing to consent to randomization to the intraperitoneal drain vs. no drain group.

 The subject is not willing to comply with 90-day follow-up and answer quality-of-life questionnaires per protocol.


PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers

Summary: The aim of this study is to compare the efficacy of a proton pump inhibitor (lansoprazole) and a histamine-2 receptor antagonist (famotidine) in preventing recurrent ulcer bleeding in patients with a history of H. pylori-negative idiopathic peptic ulcers.
Inclusion criteria: inclusion criteria:

 A history of H. pylori-negative idiopathic peptic ulcers, defined as

 No exposure to aspirin, NSAIDs or drugs of unknown nature including traditional Chinese medicine within the 4 weeks before hospitalization;

 Biopsies taken during endoscopy must be negative for both the urease test and histology for H. pylori in the absence of acid suppressive therapy; and

 No other causes of ulceration identified.

 Endoscopically confirmed ulcer healing

 Age >18 years old

 Informed consent

Exclusion criteria: :

 Concomitant steroid or anticoagulant

 Concomitant use of NSAIDs, aspirin or COX2 inhibitors

 Previous gastric surgery

 Requirement of maintenance PPI (e.g. reflux oesophagitis)

 Advanced comorbidity (defined as ASA 4 or above) or active malignancy

 Subjects who are pregnant or lactating, or is intending to become pregnant before, during, or within 1 month after participating in this study

 Subjects who have known hypersensitivity or allergies to any component of lansoprazole or famotidine.

 Subject who has current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition


Survey of Osteoarthritis Real World Therapies (MK-0663-140)

Summary: This was a study to estimate the proportion of participants with osteoarthritis of the knee(s) who were treated with oral or topical analgesics for their symptoms, who did and did not report adequate pain relief at Baseline and to characterize their pain level over a 12-month follow-up period.
Inclusion criteria: inclusion criteria:

 Clinical diagnosis of primary osteoarthritis of the knee(s)

 Presently receiving prescribed oral or topical analgesics for a minimum duration of two weeks prior to enrollment

Exclusion criteria: :

 Arthritis other than primary osteoarthritis

 Treatment with disease-modifying antirheumatic drugs (DMARDS), methotrexate or biologics

 Subtotal or total joint replacement in the affected knee

 Chronic severe pain of other causes that in the opinion of the investigator may require long-term analgesia or confound the present study

 Currently enrolled in a clinical trial or who have participated in a clinical trial within the past 30 days

['Standard of care for treatment of osteoarthritis (OA) of knee(s)']


PK and Safety Evaluation of Daptomycin in Children Ages 2-6 With Proven or Suspected Gram-positive Infections

Summary: This is a research study designed to look at the pharmacokinetics (distribution, breakdown, and removal) and tolerability of a single dose of daptomycin in patients aged 2 to 6 years who have infections that are caused by a specific group of bacteria (called Gram-positive bacteria).
Inclusion criteria: inclusion criteria:

 Written parental (or appropriate legal representative) informed consent prior to any study-related procedure not part of normal medical care;

 Male or female between the ages of 2 and 6 years old, inclusive;

 Able to comply with the protocol for the duration of the study;

 Clinically stable with no evidence of hemodynamic instability (defined as a requirement for pharmacological intervention to manage blood pressure) in the 72 hour window prior to enrollment, and no history or evidence of renal or hepatic compromise;

 Suspected or diagnosed Gram-positive infection for which the subject is receiving standard antibiotic therapy;

 A calculated creatinine clearance rate (CLcr) ≥ 80 ml/min/1.73m2 as determined by the Schwartz equation at baseline;

 Creatine phosphokinase (CPK) levels less than 2X ULN (upper limit of normal) at baseline.

 Presence of two patent intravenous lines (or comparable means of venous access) prior to dosing on Study Day 1.

Exclusion criteria: :

 Investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry;

 Known allergy/ hypersensitivity to daptomycin;

 History of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma is acceptable), gastrointestinal, endocrine, hematologic, autoimmune disease or primary immune deficiency;

 Pneumonia as sole Gram-positive infection being treated with standard antibiotics;

 Subjects with clinically significant abnormal laboratory test results [including electrocardiograms (ECGs)], as determined by Investigator;

 Administration of rifampin within 7 days of study drug administration;

 Body mass index (BMI) that is outside of the 5th to 95th percentile;

 Subjects in whom collection of the required blood volume would put them at risk of hemodynamic disturbance (at the discretion of Investigator);

 History of or current clinically significant (at the discretion of the Investigator) muscular disease, nervous system or seizure disorder;

 Administration of intramuscular injection between baseline and study drug administration or expected intramuscular injection within 24 hours following dosing;

 Expected surgical procedure(s) within 24 hours prior to and following dosing;

 Unexplained muscular weakness, history of peripheral neuropathy, Guillian-Barre or spinal cord injury;

 History of or current rhabdomyolysis.

['Gram Positive Infection', 'Concurrent Antibiotic Treatment']

Gram Positive Infection
Concurrent Antibiotic Treatment


Testosterone Replacement for Fatigue in Male Hypogonadic Advanced Cancer Patients

Summary: The goal of this clinical research study is to learn if and how testosterone replacement therapy may affect fatigue in males with advanced cancer and low testosterone levels.
Inclusion criteria: inclusion criteria:

 Male patients with any advanced cancer (metastatic or locally recurrent) who have a bioavailable testosterone (BT) of < 70 ng/dL.

 Male patients who have fatigue present every day for the last two weeks and have an Edmonton Symptom Assessment System (ESAS) fatigue score during the last 24 hours of >/= to 4 on a 0 to 10 scale (in which 0 = no fatigue and 10 = worst possible fatigue).

 Male patients who are willing to receive intramuscular injections every 2 weeks and are 18 years of age or older are eligible for this study.

 Participants must be willing to have blood samples drawn at screening and/or baseline and every two weeks until the end of treatment.

 Prostatic Specific Antigen (PSA) level must be lower than 4.0 ng/mL to be eligible for this study and Digital Rectal Exam (DRE) must be normal.

 Eastern Cooperative Oncology Group (ECOG) PS </= 3 and participants must be able to stand up with or without assistance and to ambulate.

 Hemoglobin (Hgb) >/= 9 g/dL. If the patient has not had blood drawn for a hemoglobin level in the past 28 days, one will be done to determine eligibility. Patients with a hemoglobin < 9 g/dL will be referred for treatment of their anemia.

Exclusion criteria: :

 Patients who are determined incapable of completing questionnaires due to cognitive or physical deficits are ineligible for this study

 Abnormal Digital Rectal Exam (DRE) at baseline or history of severe untreated benign prostatic hypertrophy (BPH) with International Prostatic Symptom Score (IPSS) >19.

 Patients with a history of prostate cancer, a history of breast cancer or adenocarcinoma of unknown origin.

 A history of untreated obstructive sleep apnea.

 Uncontrolled severe heart failure (NYHA Class III or IV), uncontrolled cardiac arrhythmia or severe chronic obstructive pulmonary disease (COPD) requiring home oxygen.

 Patients who have evidence of pre-existing hypopituitarism/hypogonadism including status post bilateral orchiectomy, for which replacement therapy is mandated, are ineligible for this study.

 Patients exhibiting clinically diagnosed severe dehydration are ineligible.

 Patients with a history of uncontrolled arrhythmia.

 Patients who are currently receiving androgen therapy or dehydroepiandrosterone (DHEA)

 Diabetics with a history of frequent episodes of hypoglycemia or uncontrolled diabetes mellitus (DM) defined as a fasting glucose over 200 mg/dL or HbA1c above 8%.

 Uncontrolled thyroid disease

 Hypercalcemia (corrected calcium > 10.5 g/dL); estimated glomerular filtration rate < 60 mg/min using the Modification of Diet in Renal Disease glomerular filtration rate (MDRD GFR); ALT > 3x the upper limit of normal (UNL)

 Patients on warfarin, cyclosporine, dong quai, eucalyptus, dicumarol, germander, Jin bu huan, kava, pennyroyal, chaparral, comfrey, phenprocoumon are ineligible for this study.

 Unstable symptoms could contribute to fatigue such as severe pain (score> 6 on ESAS) or severe depression (defined as a score of 15 or greater on the Depression Subscale of the Hospital Anxiety Depression Scale [HADS]). These symptoms should be resolved or stable for >/= 2 weeks at baseline for inclusion into study.

 Patients with hematocrit (Hct) > upper normal limits (UNL) will be excluded due to possible polycythemia. If the patient has not had blood drawn for a hematocrit level in the past 28 days, one will be performed at baseline to determine eligibility.

 Patients who have a known sensitivity to sesame seed products.


Phase II Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia

Summary: The purpose of this research study is to compare in patients with double-sided claudication if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in one of the severly diseased ischemic limbs(legs)versus the control limb that receives a placebo product.~Limb Ischemia (LI) is a severe obstruction of the arteries which seriously decrease blood flow to the extremities (mainly feet and legs) and has progressed to the point of severe pain and even skin ulcers or sores.~LI needs comprehensive treatment since the condition will not improve on its own. The overall goal of treatment is to reduce pain and increase blood flow to improve symptoms or save the leg and feet. In many cases, current options for treatment including medications, surgery or endovascular procedures have not been successful.~In the last few years, investigators have explored therapies aimed to increase blood flow to the ischemic vessel by transplanting cells that will promote the development of new vessels in the diseased leg.~The study hypothesis is based on the concept that the process of formation of new blood vessels is complex and requires the participation of several types of stem cells and growth factors. The lack of any of these components will produce vessels which are immature and unable to provide appropriated blood supply to the leg.~Patients eligible to participate in the this study are those suffering from double-sided claudication with poor circulation or severe leg blockages, which are not candidates for surgical procedures.~Once the mixture of stem cells is prepared and the patient's bone marrow is ready, cells will be transplanted into the calf muscle of one the the diseased legs while the other diseased leg will receive the placebo. Clinical study to evaluate and compare the efficacy of the stem cell transplant will be performed for six months post cell transplant.
Inclusion criteria: inclusion criteria:

 Males or females older than 18 years of age.

 Limb ischemia with ABI of < 0.7 in the index lower extremity in two consecutive examinations done at least 1 week apart.

 Limb ischemia with resting ischemic pain and/or claudication at 100 meters and/or non-healing ulcers.

 Claudication

 Patients not considered candidates for surgical or percutaneous revascularization, due to poor target vessels, inability to cross total occlusions, or a morbidity which precludes general anesthesia.

Exclusion criteria: :

 Inability to provide informed consent.

 Previous angiogenic therapy.

 Known sensitivity to gentamycin and/or amphotericin B.

 Use or expected use of antineoplastic drugs.

 Any illness, which might affect the patient's survival after enrollment in the protocol.

 Any illness or significant laboratory abnormality, which in the investigator's judgment will interfere with the patient's ability to comply with the protocol, compromise the patient's safety, or interfere with the interpretation of the study results.

 No evidence of acute infection

 WBC > 15000.

 WBC < 4000.

 Serum Creatinine > 3.0 mg/dL in patients who are not in hemodialysis.

 Pregnant women or women planning to become pregnant or unwilling to use appropriate birth control methods before and 2 months after cell infusion.

 Recent myocardial infarction within 3 months prior to screening.

['Critical Limb Ischemia', 'Severe Leg Ischemia', 'Peripheral Artery Disease', 'Peripheral Vascular Disease']

Critical Limb Ischemia
Severe Leg Ischemia
Peripheral Artery Disease
Peripheral Vascular Disease


Endothelial Dysfunction and Chronic Obstructive Pulmonary Disease

Summary: The purpose of this study is to investigate the role of endothelial dysfunction in chronic obstructive pulmonary disease.
Inclusion criteria: inclusion criteria:

 COPD patients in stable condition ( without exacerbation min 1 months ago)

 Over 40 years

 History of at least 10 py

Exclusion criteria: :

 acute exacerbation of COPD

 active malignancy

 autoimmune disease

 acute myocardial infarction

 diabetes mellitus with late complications

 congestive heart failure

 women of childbearing potential

['Chronic Obstructive Pulmonary Disease', 'Endothelial Dysfunction']

Chronic Obstructive Pulmonary Disease
Endothelial Dysfunction


Azithromycin in Combination With Chloroquine Versus Chloroquine in the Eradication of Asymptomatic Plasmodium Falciparum

Summary: The purpose of this study is to determine if Azithromycin in combination with chloroquine is superior to chloroquine alone in eradicating P. falciparum asexual parasitemia in asymptomatic, semi-immune adults in Western Kenya.
Inclusion criteria: inclusion criteria:

 Healthy adult: male or female

 Asymptomatic mono-infection with P. falciparum parasitemia with a parasite density of 1000 - 30,000 parasites/Î¼L

 Age 18 years to 60 years

 Willingness to sign and ability to understand consent form

 Willingness and ability to return for scheduled follow up visits

Exclusion criteria: :

 Mixed malaria infection by Giemsa smear

 History of allergy to or hypersensitivity to chloroquine, Azithromycin or other macrolides (e.g. erythromycin, clarithromycin)

 Any of the following: a.) Antimalarial therapy administered in the past 4 weeks, including quinine therapy or an artemisinin derivative; or b.) An antibacterial with known antimalarial activity (including, erythromycin, doxycycline, clindamycin, cotrimoxazole) within one week prior to enrollment into the study

 Fever, history of fever in past 48 hours, or signs/symptoms of malaria (including acute or subacute headache, nausea, or vomiting)

 Inability to swallow oral medication

 Laboratory evidence or history of significant cardiovascular, liver, hematologic or renal functional abnormality

 Any situation which could prevent the patient from returning to follow up visits

 Pregnancy or breast feeding

 Any other concurrent illness that may confound the result

 Any other condition or circumstance that in the opinion of the Investigator may pose a threat to the study participant or study


Effect of Traditional Chinese Medicine on Outcomes in Patients With Severe / Very Severe COPD

Summary: The aim of this study is to compare the effectiveness of two treatments for severe / very severe COPD patients: one, conventional medicine based on 2013 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines; the other, TCM treatments and conventional medicine, which have been evaluated and have certain effect.
Inclusion criteria: inclusion criteria:

 A confirmed diagnosis of severe to very severe COPD.

 medically stable

 Age between 40 and 80 years.

 Syndrome differentiation belongs to syndrome of deficiency of pulmonosplenic qi, syndrome of insufficiency of qi of the lung and kidney, syndrome of insufficiency of qi and yin of the lung and kidney.

 with a two-week wash-out period prior to randomization

 Without participations in other interventional trials in the previous one month.

 With the informed consent signed.

Exclusion criteria: :

 Pregnant or breast-feeding women.

 Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study.

 Current respiratory disorders other than COPD (e.g., bronchiectasis, bronchial asthma, tuberculosis, lung fibrosis, pulmonary thromboembolic, diffuse panbronchiolitis).

 Complicated with a neuromuscular disorder, which affected the respiration.

 Complicated with heart failure (NYHA Class III or IV),or myocardial infarction within six months ,or unstable hemodynamics.

 Complicated with malignancy, congenital or acquired immune deficiency.

 Complicated with serious hepatic and renal diseases (liver cirrhosis, portal hypertension, bleeding of varicose veins, dialysis, or renal transplantation).

 Participating in other trials or allergic to the used medicine.

['Salmeterol / fluticasone (Seretide®)', 'Bufeijianpi granule', 'Bufeiyishen granule', 'Yiqizishen granule', 'Placebo Bufeijianpi granule', 'Placebo Bufeiyishen granule', 'Placebo Yiqizishen granule']

Salmeterol / fluticasone (Seretide®)
Bufeijianpi granule
Bufeiyishen granule
Yiqizishen granule
Placebo Bufeijianpi granule
Placebo Bufeiyishen granule
Placebo Yiqizishen granule

['Pulmonary Disease, Chronic Obstructive']


Influence of Chloroquine on HIV Viral Load Among Pregnant Women in Uganda

Summary: There is conflicting evidence regarding the influence of HIV infection on the success of malaria prevention in pregnancy and effect on pregnancy outcome. The purpose of the proposed study is to assess the impact of HIV infection on the effectiveness of malaria prevention during pregnancy. This will be carried out by comparing two intermittent preventive treatments (IPTs) with sulfadoxine/pyrimethamine (SP) plus 300 mg weekly chloroquine with two doses IPT plus a weekly chloroquine placebo. The emphasis will be on assessing the effect of chloroquine on HIV viral load and malaria morbidity and foetal outcome.~The study will be a randomised double-blind placebo-controlled trial with two arms, involving pregnant women attending antenatal classes (ANCs) at health units, enrolled early in their second trimester at 3 health units of the Mbarara district and Kampala. All pregnant women presenting for antenatal care, irrespective of parity, who consent to participate will be enrolled. Women with severe systemic disease or symptoms of AIDS will be excluded from the study data analysis.~Women will be screened for HIV status and their HIV viral loads will be measured at enrolment. Parasitaemia will be assessed at enrolment; at the beginning of the third trimester; and at delivery. Haemoglobin will be measured at the same time points.~The main outcome variables to be assessed will be maternal peripheral parasitaemia; placental parasitaemia; maternal clinical malaria; congenital parasitaemia; and maternal and neonatal haemoglobin, birth weight and viral load at enrolment and before nevirapine administration to the HIV positive mothers at birth.~Anthropological pre-studies to assess the quality of ANC services and healthcare seeking practices of pregnant women in the study area will be carried out. Focus group discussions (FGD) with pregnant women and mothers of neonates; in-depth interviews with relevant health workers; and illness narratives from pregnant women will be used to collect data. The anthropological study results will assist in appropriately planning for the trial to enhance compliance to the intervention.~The data collection is planned to commence in August 2003 and is expected to end in October 2005. Twelve months will be spent on the write-up phase.
Inclusion criteria: inclusion criteria:

 Pregnant women

 14-24 weeks gestation

 Consent

 Presenting for ANC at study hospitals/centres

 Agree to have an HIV test and to be examined for viral load

Exclusion criteria: :

 Severe systemic disease

 AIDS-related disease

 At-risk pregnancy

['sulfadoxine-pyrimethamine intermittent preventive treatment', 'chloroquine']

['Malaria in Pregnancy', 'HIV Infections']


An Open Phase 3 Study of IV-Globulin SN Inj.10% to Treat Immune Thrombocytopenia

Summary: Human immunoglobulin (Ig) is the most commonly used blood product. It has been well-defined the efficacy in patients with immunodeficiencies, Kawasaki disease, asthma and other immune diseases. It is expected that Ig 10% will improve the usefulness and safety profile compared to Ig 5% because it is expected the reduced hospitalization/treatment duration and less adverse events related to volume overload.
Inclusion criteria: inclusion criteria:

 Given written informed consent

 Male or female aged ≥ 19

 Primary immune thrombocytopenia (ITP)

 Platelet <20x10^9 /L

 Patients who have taken adrenal cortical hormones and/or other immunosuppressive medications should maintain their stable doses before and during this study

Exclusion criteria: :

 Patients who have participate in other interventional study within 30 days

 Inability in written/verbal communication

 Engaged with an elective surgery

 Pregnant or breast-feeding women

 Women of childbearing potential who do not agree with contraception during this study

 Patients who had experienced any hypersensitivity or shock with study drug or active ingredient

 Refractory to immunoglobulin therapy

 Secondary immune thrombocytopenia

 HIV-associated ITP

 Lupus-associated ITP

 Lymphproliferative disease

 Hepatitis virus carrier

 Other disease- or infection-associated ITP

 Drug-Induced ITP

 Hereditary thrombopenia (e.g., MYH9 disorders)

 Hemolytic anemia (Positive direct Coomb's test)

 Clinically significant abnormalities of immunoglobulin

 Immunoglobulin A Deficiency

 Immune disorders or deficiency

 Alcohol or drug abuse within 6 months

 Patients who had taken any medications which may effect platelet function or count for at least 2 days prior study entry

 Patients who had administrated with IVIg or anti-D immunoglobulin agents within 1 month

 Patients who had undergone a splenectomy within 2 months

 Clinically significant underlying disease or medical history at investigator's discretion


Effect of Ozone on Airway Inflammation in Allergic Asthmatics Treated With Omalizumab

Summary: Ozone can cause acute airway inflammation in both asthmatics and normal volunteers. However, in asthmatics ozone can cause episodes of worsening of asthma. We want to learn if chronic allergic response, known as IgE-induced airway inflammation is what causes the increased inflammation in response to ozone. To do this we will examine the response to ozone in a group of asthmatics treated with omalizumab, a medicine available and approved for use in people with asthma, or a placebo control. The placebo for this study is inert physiologic saline (salt water) which contains no omalizumab. Both the omalizumab and the placebo will be administered as an injection under the skin. Omalizumab, also called Xolair, is a humanized monoclonal antibody, which means that it originally was produced in mice, then genetically engineered to look more like human than mouse antibody. Omalizumab inactivates IgE, a protein our own immune systems make as part of allergic reactions. The purpose of this study is to test the hypothesis that omalizumab, by blocking this aspect of allergic reactions, will decrease the number of inflammatory cells in the airway after ozone challenge. We also hypothesize that omalizumab will decrease the effects of ozone on changes in lung function, mucociliary clearance (a measure of how quickly mucus clears form the airway) and airway reactivity. Airway reactivity is a measure of how sensitive the airways are to a medication used to diagnose asthma, called methacholine. We will examine these as additional information we can learn during the course of the study. This is a blinded study, meaning that neither you nor the researchers know if you get the active drug or placebo, but that information can be obtained if needed. The placebo is an injection of inert physiological saline (salt water) which contains no omalizumab.
Inclusion criteria: inclusion criteria:

 Normal lung function, defined as (Knudson 1976/1984 predicted set):

 FVC of > 80 % of that predicted for gender, ethnicity, age and height

 FEV1 of > 80 % of that predicted for gender, ethnicity, age and height

 FEV1/FVC ratio of > 80 % of predicted values

 Evidence of allergy to house dust mite

 Oxygen saturation of > 94 %

 Normal blood pressure (Systolic between 150 - 90, Diastolic between 90-60 mm Hg)

 Symptom Score (defined in section f) no greater than 20 (out of a possible 60) for total symptom score with a value no greater than 3 for any one score. No more than one score may be greater or equal than 3.

 IgE within the following ranges and body weights for omalizumab dosing: IgE ≥30-700 int. units/mL, and weight 30-90 kg.

Exclusion criteria: :

 A history of significant chronic illnesses (to include diabetes, autoimmune diseases, immunodeficiency state, known ischemic heart disease, chronic respiratory diseases such as chronic obstructive pulmonary disease or severe asthma, hypertension)

 Allergy to any medications which may be used in the course of this study (albuterol, acetaminophen, aspirin or non-steroidal anti-inflammatory agents, corticosteroids, lactose, polyethylene glycol)

 Positive pregnancy test at time of initial screening

 Medications which may impact the results of the ozone challenge, interfere with any other medications potentially used in the study (to include steroids, beta antagonists, non-steroidal anti-inflammatory agents) or suggest an ongoing illness (such as antibiotics)

 Mega doses of vitamins and supplements, homeopathic/naturopathic medicines

 Acute, non-chronic, medical conditions, including (but not limited to) pneumonia or bronchitis requiring antibiotics, febrile illnesses, flu-like symptoms must be totally resolved symptomatically for 2 weeks. Documentation of normal lung function (as defined in Specific inclusion criteria) must be met.

 Unspecified illnesses, which in the judgment of the investigator increase the risk associated with ozone inhalation challenge, will be a basis for exclusion.

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

 Use of systemic steroid therapy within the preceding 12 months.

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

 Use of daily theophylline within the past month.

 Pregnancy or nursing a baby.

 Cigarette smoking > 1 pack per month.

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

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

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

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


Near Patient Microbial Testing in Cystic Fibrosis

Summary: To identify whether home monitoring of multiple physiological parameters and biomarkers in sputum could provide advanced warning of an infective exacerbation or treatment failure before changes in patient-reported symptoms.
Inclusion criteria: inclusion criteria:

 Diagnosis of Cystic Fibrosis based on genetic testing and/or sweat chloride levels.

 Chronic infection with Pseudomonas aeruginosa.

 Patients able to produce daily sputum samples.

 Current history of at least two pulmonary infective exacerbations in the past 12 months.

 Able to give written informed consent

Exclusion criteria: :

 Unable to provide written informed consent

 Patients unable to produce daily sputum samples

 Fewer than two infective pulmonary exacerbations in 12 months


Efficacy, Safety and Tolerability of Co-artemether in Non-immune Travelers

Summary: This study will assess the safety and efficacy of co-artemether in the treatment of acute uncomplicated P. falciparum malaria in returning non-immune travellers~THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES
Inclusion criteria: inclusion criteria:

 Patients were eligible for inclusion if they met all of the following criteria:

 Male or female aged 18 or older (prior to Amendment 1: more than 2 years old)

 Non-immune patients suffering from acute uncomplicated P. falciparum malaria, or mixed infection including P. falciparum, with parasitemia of less than or equal to 2% asexual P.falciparum parasites, confirmed by microscopy using Giemsa-stained thick film.

 Non-immune patients were regarded as those who had not spent the first five years of their life, nor the last five years in a malaria endemic area, and did not have acute P. falciparum malaria diagnosed during those past five years.

 Non-immune patients who had received prophylaxis with anti-malarials (excluding halofantrine) were included only if clear progression of acute P. falciparum infection was documented.

 Female patients were eligible to participate in the study if they were of non-childbearing potential or had a negative pregnancy test (urine or serum) at screening, and using an acceptable contraceptive method

 Patients, who had been informed of the study procedures and medication, and had given written informed consent and were willing to comply with the study protocol.

Exclusion criteria: :

 Patients were to be excluded from participation if they met any of the following criteria:

 Known hypersensitivity to artemether or lumefantrine

 Signs/symptoms indicative of severe/complicated malaria according to the WHO classification (e.g. cerebral malaria, see Post-text supplement 1)

 Treatment with artemisinin derivatives within the previous 7 days

 Concurrent administration of other treatment / prophylaxis for malaria

 Concurrent administration of medications with potential hemolytic effects

 Patients taking any drug metabolized by cytochrome isoenzymes CYP3A4 or CYP2D6

 Received any other investigational drugs in the last 4 weeks before entry into the study

 Severe cardiac impairment (i.e. evidence of existing cardiac conduction defect or overt symptoms of cardiac dysfunction or abnormalities of baseline ECG not associated with acute malaria); clinically relevant bradycardia or congestive cardiac failure with reduced left ventricular ejection fraction; pre-existing prolongation of the QT interval; history of symptomatic cardiac arrhythmias

 Having received halofantrine or any other drug known to influence cardiac function within 4 weeks prior to Screening visit or taking other drugs that are known to prolong the QT interval, including class IA and III antiarrhythmics, neuroleptics, antidepressive agents, certain antibiotics (including some macrolides, fluoroquinolones, imidazole, and triazole antifungal agents), certain non-sedating antihistaminics (terfenadine, astemizole) and cisapride

 History of splenectomy

 Clinically significant abnormal baseline hematology (not associated with acute malaria) or clinical chemistry parameters, including evidence of hepatic or renal impairment, known disturbances of electrolyte balance e.g. hypokalemia or hypomagnesaemia

 Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study, or concomitant disease which could mask the response to treatment

 Unlikely, in the opinion of the investigator, to complete the dosing or follow-up periods, or who have evidence of alcohol, drug or solvent abuse.

 Women who are pregnant, lactating or of childbearing potential and not using an acceptable contraceptive method were also excluded.

 Other protocol inclusion/

['Acute Uncomplicated P. Falciparum Malaria']


A Study of the Efficacy of Preventive Dosing of Fondaparinux Sodium Versus Placebo for the Prevention of Venous Thromboembolism (VTE) in Patients Undergoing Coronary Bypass Surgery Receiving Routine Mechanical Prophylaxis

Summary: This trial is a prospective, single-center Phase II randomized study to demonstrate the superior efficacy of Fondaparinux Sodium subcutaneous injections in patients undergoing CABG surgery (isolated and redo isolated) versus treatment with placebo. All consecutive patients scheduled for CABG surgery that meet the general inclusion and none of the exclusion criteria will be considered for enrollment in the study.~Consecutive patients will be randomized on the day of admission prior to their CABG surgery into one of two groups. One group will be randomized to the placebo while the second group will receive 2.5 mg Fondaparinux Sodium injections. Both groups will receive routine mechanical prophylaxis as determined by the treating physicians. Group randomized to receive Fondaparinux Sodium will receive a 2.5 mg SQ daily drug dose starting 12 +/- 2 hours post-wound closure or the following day in the morning (at the discretion of the cardiothoracic surgeon). The second dose would be administered 24 hours later and the dosing will then be once a day. The group randomized to placebo will receive subcutaneous equivolume isotonic saline at the same time points described above.~Patients randomized will receive a 2.5 mg dose of Fondaparinux Sodium or placebo subcutaneously for a total of 3-9 days post CABG with day 1 being the day of surgery. The drug will be discontinued if the patient is discharged before day 9. If the patient stays for more than 9 days inside hospital, a duplex would be obtained per protocol and further DVT prevention measures would be instituted per the discretion of treating physician.~Patients will be assessed daily while hospitalized for any symptoms and adverse reactions and will undergo laboratory testing (CBC, PT/INR, PTT and UA) as specified in the protocol. Post-op day 3-9(no later than 2 days after the last preventive drug dose) patients will undergo the protocol specific lower limb venous duplex scan and earlier if symptomatic. Patients will also be contacted (phone/office visit) for follow-up 25-35 days post CABG to assess for signs or symptoms of deep venous thrombosis or thromboembolism and for any potential complications.
Inclusion criteria: Subject inclusion criteria In order to be enrolled in the study, subjects must meet all of the inclusion criteria as listed below.

 Consecutive patients undergoing isolated or redo isolated CABG

 Patients must provide written informed consent

 Patients must agree to comply with study procedures for the entire length of the study.

 Must be 18 years old or greater.

 Subject
Exclusion criteria:  Any subject that meets any of the

['Deep Vein Thrombosis', 'Coronary Artery Bypass Surgery', 'Venous Thromboembolism']

Deep Vein Thrombosis
Coronary Artery Bypass Surgery
Venous Thromboembolism


Special Drug Use Investigation of Xarelto for Venous Thromboembolism (VTE)

Summary: The objective of this investigation is to assess safety and effectiveness of Xarelto under practice routine use in VTE secondary prevention after acute DVT, focusing on hemorrhagic-related AEs, recurrent venous thromboembolism (PE/DVT), all-cause mortality. This study is a company sponsored, one- arm prospective cohort study with patients to whom Rivaroxaban treatment for VTE (PE/DVT) has been chosen. The study includes a standard observation period (1 year) and an extension survey period (2 years, at the longest).
Inclusion criteria: inclusion criteria:

 - Patients who start rivaroxaban for VTE(pulmonary embolism, deep vein thrombosis) anticoagulation therapy.

Exclusion criteria: :

 - Patients who are contraindicated based on the product label and have already received Xarelto treatment.


Impact of Therapeutic Educational Programme on the Alzheimer's Disease Affected Patient's Quality of Life

Summary: Therapeutic education expands in Alzheimer's Disease management in France. Several studies revealed a positive impact on caregiver's burden and/or quality of life. The purpose of this study, is to determine whether a therapeutic educational programme for both AD patients and primary caregivers, in community dwelling, improves patient's quality of life.
Inclusion criteria: inclusion criteria:

 patient suffering from mild to moderately severe Alzheimer's disease patients (MMSE 11 to 26)

 in community dwelling

 with an informal caregiver (person living with the patient or providing care 3 times a week or 8 hours per week)

 is informed and has given his/her consent

 whom caregiver is informed and has given his/her consent

Exclusion criteria: :

 patient with other type of dementia

 living in nursing home or long term care

 with no caregiver

 not informed or has not given his/her consent

 whom caregiver is not informed or has not given his/her consent


Assessment of Anaemia Attributable to Schistosomiasis in School Children in Kenya: Mechanisms and Effect of Treatment

Summary: The purpose of this study is to determine the extend and the nature of anemia in school children and the correlation between anemia and schistosomiasis infections, malaria infections and/or malnutrition (iron deficiency).
Inclusion criteria: inclusion criteria:

 school children between 9 to 12 year
Exclusion criteria:

['Anaemia', 'Schistosomiasis Infection', 'Malaria', 'Iron Deficiency']

Anaemia
Schistosomiasis Infection
Malaria
Iron Deficiency


Comparison Of The Berlin Questionnaire To The Portland Sleep Quiz

Summary: This trial is enrolling patients who are already being seen at OHSU sleep disorder center or have been referred for clinical reasons by their physician to the OHSU sleep disorder center and are going to have a sleep study that would be paid for by their insurance company for clinical reasons.~The purpose of this study is to determine whether the Portland sleep apnea quiz has a higher specificity and negative predictive value then the Berlin Sleep Questionnaire in a patient population with a high predisposition to sleep apnea presenting to a sleep center.
Inclusion criteria: inclusion criteria:

 Adults more than 18 years old

Exclusion criteria: :

 Subjects Unwilling to Complete the Questionnaire


Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region

Summary: The purpose of this study is to compare the efficacy of etanercept with usual disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe rheumatoid arthritis (RA) over 16 weeks in the Asia Pacific region.
Inclusion criteria: inclusion criteria:

 Diagnosis of RA

 Currently receiving an adequate dose of methotrexate (MTX) for treatment of RA

 Active RA at time of screening and baseline

Exclusion criteria: :

 Previous or current treatment with etanercept (ETN), other tumor necrosis factor-alpha inhibitors, or other biologic agents

 Concurrent treatment with a DMARD, other than MTX, at screening

 Receipt of any DMARD, other than MTX, within 3 months before screening

['Etanercept , Methotrexate', 'Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide']


Epidemiology of Carotid Disease in Elderly Adults

Summary: To determine whether a population with isolated systolic hypertension (ISH) had a higher prevalence of carotid disease than a normotensive population matched for age and sex, and to determine specific risk factors for carotid disease.
Inclusion criteria: No eligibility criteria
Exclusion criteria:

['Cardiovascular Diseases', 'Heart Diseases', 'Hypertension', 'Carotid Artery Diseases', 'Atherosclerosis']

Cardiovascular Diseases
Heart Diseases
Hypertension
Carotid Artery Diseases
Atherosclerosis


Angiomax® or Unfractionated Heparin for Patients Undergoing Percutaneous Coronary Intervention

Summary: The objective of the study is to assess the safety and efficacy of Angiomax® (bivalirudin) versus unfractionated heparin (UFH) in patients presenting with stable angina or silent ischemia (positive stress test without chest pain) that undergo percutaneous coronary intervention (PCI).~The primary endpoint of the study will be major and minor bleeding events, defined by the REPLACE-2 trial definition, during the index hospitalization and up to 30 days post discharge.
Inclusion criteria: inclusion criteria:

 The patient is male or female ≥ 18 years of age.

 The patient presents with stable angina pectoris, or silent ischemia (positive stress test without chest pain).

 The patient is scheduled for coronary angiography, with possible angioplasty.

 The patient is able to tolerate dual anti-platelet therapy with aspirin and clopidogrel for a minimum of 30 days and is on those medications at the time of the PCI (clopidogrel may be administered during PCI or within 30 minutes post PCI).

 The patient is able and willing to conform to the requirements of the study and voluntarily signs an Informed Consent.

 The patient does not present with any form of illness or condition that in the investigator's opinion would impair the results of the study.

 Women of child bearing potential must have a negative urine or serum pregnancy test prior to enrollment.

Exclusion criteria: :

 Patients in cardiogenic shock.

 Patients with acute coronary syndrome, which includes unstable angina, non-ST-elevation MI or STEMI.

 Known history of heparin-induced thrombocytopenia.

 Contraindication to unfractionated heparin, bivalirudin, or any anticoagulant or antithrombotic pharmacological agent.

 Any significant medical condition, which in the investigator's opinion, may interfere with the patient's optimal participation in the study.

 Pregnant women or nursing mothers.


Improving Care for Patients With Diabetes and Poor Numeracy Skills

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

 Clinical diagnosis of Type 1 or 2 Diabetes;

 most recent A1C greater than or equal to 7.0%;

 Referred to the Diabetes Improvement Program for diabetes care;

 Age 18-80;

 English Speaking.

Exclusion criteria: :

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

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

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


A Comparison of mNT-BBAVF and BCAVF in Hemodialysis Patients

Summary: A well-functioning vascular access is essential for effective hemodialysis. The native arteriovenous fistula (AVF) is the preferred vascular access because of the lower thrombosis and infection risks compared to either synthetic arteriovenous grafts or central venous catheters. Brachiocephalic arteriovenous fistula (BCAVF) and transposed brachiobasilic arteriovenous fistula (T-BBAVF) are recommended when there is either a primary failure or no suitable vessels for the forearm fistula. However, BCAVF is frequently cannulated at the antecubital fossa, the risks of stenosis and thrombosis are high, which will compromise proper BCAVF function and survival. T-BBAVF is not only technically challenging, but also associates with severe arm swelling and pain. Thus, the investigators introduced a novel modified Non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) for long-term hemodialysis patients. To confirm its efficacy, a prospective clinical study would be carried out.
Inclusion criteria: inclusion criteria:

 Age from 18 to 75 years;

 Radial artery diameter <2.0 mm or cephalic vein diameter in the forearm <2.5 mm;

 Brachial artery diameter ≥ 2 mm

Exclusion criteria: :

 Stenosis or thrombosis present in the draining vein;

 A history of peripheral ischemia in upper extremities;

 Active local or systemic infections;

 Inability to consent for the procedure;

 Patients with previous dysfunctional forearm fistula.


Cytoprotective Agent and Peptic Ulcer in Dual Antiplatelet :RCT

Summary: Primary objective : To evaluate the efficacy of Rapamide in peptic ulcer prevention in patients taking dual antiplatelet agents~Study Design: Single center, double-blind, randomized-control trial study~Study drug: Repamipide vs. placebo~Assessment criteria The patients will be discharged from the study when one of the followings occurred,~Peptic ulcer from upper endoscopy at 3 and 6 month follow up~Clinical of upper gastrointestinal bleeding with peptic ulcer from upper endoscopy~Anemia by CBC at 1,3 ,6,12 month with peptic ulcer from upper endoscopy~Evidence of recurrent myocardial infarction from stent thrombosis
Inclusion criteria: inclusion criteria:

 Age 18-70 year-old

 Had cardiovascular disease which needed clopidogrel and aspirin

 Stable enough for gastroscopy

Exclusion criteria: :

 Gastroscopy revealed peptic ulcer

 Had contraindication for gastroscopy

 Not allowed for gastroscopy by cardiologist

['Gastric Ulcer Induced by Anti-platelet Agent', 'Duodenal Ulcer Induced by Anti-platelet Agent']


Trial on the Efficacy and Safety of Two Different Glucocorticoid Dose Regimens in Allergic Bronchopulmonary Aspergillosis

Summary: Allergic bronchopulmonary aspergillosis (ABPA) is a pulmonary disorder caused by a complex hypersensitivity response to antigens released by the fungus Aspergillus fumigatus. Oral corticosteroids are currently the treatment of choice for ABPA associated with bronchial asthma. They not only suppress the immune hyperfunction but are also anti-inflammatory. However, there is no data to guide the dose and duration of glucocorticoids and different regimens of glucocorticoids have been used in literature. The disorder is highly prevalent in India. The investigators have previously reported their experience with screening stable outpatients with bronchial asthma and acute severe asthma for ABPA. The investigators have also recently reported the prognostic factors associated with clinical outcomes in patients with ABPA.~The aim of this prospective randomized controlled trial (RCT) is to evaluate the efficacy and safety of two different glucocorticoid dose protocols in patients with ABPA.
Inclusion criteria: inclusion criteria:

 Diagnosis of ABPA

 Presence of all the following three criteria:

 immediate cutaneous hyperreactivity on aspergillus skin test

 elevated total IgE levels > 1000 IU/mL

 A fumigatus specific IgE levels > 0.35 kU/L, AND,

 Presence of two of the following criteria:

 presence of serum precipitating antibodies against A fumigatus

 fixed or transient radiographic pulmonary opacities

 absolute eosinophil count > 1000/µL

 central bronchiectasis on HRCT

Exclusion criteria: :

 If they have taken glucocorticoids for more than three weeks in the preceding six months

 Failure to give informed consent

 Enrollment in another trial of ABPA


Rituximab (RTX) Therapy in Patients With Active TAO

Summary: Thyroid Associated Ophthalmopathy is condition affecting the eyes of about 10% of patients with Graves disease. Its combination of protrusion affecting the looks of the patient and pain is often severely affecting the quality of life among these patients.~The standard treatment for this illness today is intravenous glucocorticoids together with methotrexate. The purpose of this study is to evaluate the effect of rituximab on patients that do not respond to or relapse after conventional therapy.
Inclusion criteria: inclusion criteria:

 ◦Man or woman between 18-70 years TAO with CAS of ≥ 4 (less than 3 months).

 Euthyroid for at least 6 weeks

Exclusion criteria: :

 Dysthyroid optic neuropathy (DON)

 Ulcerative Keratitis

 Previous treatment with steroids for TAO (do not include prophylaxis for TAO in connection with radio iodine treatment)

 Previous Treatment with Rituximab (MabThera®)

 Positive Hepatitis B or C serology.

 Receipt of a live vaccine within 4 weeks prior RTX+MTX to randomization

 History of recurrent significant infection or history of recurrent bacterial infections

 Patient who may not attend to the protocol according to the investigators opinion.

 Pregnancy or lactation

 Significant cardiac, including significant or uncontrolled arrhythmia, or pulmonary disease (including obstructive pulmonary disease).

 Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications

 Concomitant malignancies or previous malignancies.

 Previous active tuberculosis

 Alcoholism

 Alcoholic related liver disease or other chronical liver disease

 Bone marrow depression with leukopenia, thrombocytopenia or significant anemia

 Rheumatoid or other significant pulmonary disease

 Allergy to the active substance or any other substance in the medications or murine proteins

 Active, severe infections (such as tuberculosis, sepsis or opportunistic infections)

 Patients with severe immunosuppression

 Severe cardiac failure or severe uncontrolled heart disease

['Rituximab', 'Iv Methylprednisolone', 'peroral methylprednisolone and Methotrexate']


Randomized Control Trial Comparing Prokinetics and Their Influence on Endoscopy Outcomes for Upper GI Bleed.

Summary: This is a study comparing the effect of erythromycin or metoclopramide, 2 prokinetic drugs (Drugs which are known to speed up the emptying of the stomach or in other words to move the blood out of the stomach faster) given before endoscopy to patients with upper Gastrointestinal bleeding compared to patients who will not receive either of these medications before their endoscopy.
Inclusion criteria: inclusion criteria:

 Adult patients (18-80)

 who are admitted to the ICU for hematemesis, or coffee ground emesis

Exclusion criteria: :

 Patients younger than 18 yrs old or older than 80 yrs

 Patients who refuse to consent to be in our study

 Pregnant patients

 Prior use of prokinetics in the last 48 hours

 History of cardiac arrhythmia

 Allergy to erythromycin or metoclopromide

 Patients with QT prolongation (query 7)

 -


Non-invasive Assessment of Pulmonary Vascular Resistance in Elderly Patients With Chronic Obstructive Pulmonary Disease

Summary: Many studies have evaluated the viability of measuring the pulmonary vascular resistance (PVR) by non-invasive methods in patients with pulmonary hypertension, pulmonary thromboembolism, ischemic cardiopathy and valvular disease. The investigators have not found other studies which evaluate the PVR in elderly patients with COPD. The hypothesis is that in patients with COPD, the severity of obstruction, expressed by GOLD class, is associated with an increase of PVR.
Inclusion criteria: inclusion criteria:

 diagnosis of COPD stage II, III or IV according to the GOLD guidelines

 signed the informed consent

Exclusion criteria: :

 ischemic cardiopathy

 severe valvular disease

 atrial fibrillation

 left bundle branch block

['Chronic Obstructive Pulmonary Disease', 'Pulmonary Hypertension', 'Cor Pulmonale']

Chronic Obstructive Pulmonary Disease
Pulmonary Hypertension
Cor Pulmonale


Intra Ocular Pressure During Robotic Prostatectomy

Summary: Our goal is to study the relationship between intraocular pressure during robotic prostatectomy surgery and visual deficiencies/vision loss after surgery. We believe the risk of vision loss from this surgery to be due to positioning during the operation, as well as abdominal carbon dioxide insufflation. As robotic procedures are gaining in popularity, we should determine whether they are subjecting this patient population, and perhaps more likely the patient with a preoperative diagnosis of glaucoma, to an increased likelihood of postoperative visual disturbance.If our hypothesis that intraocular pressure is increased in these patients is confirmed, future studies will assess therapeutic modalities to maintain the IOP near baseline.
Inclusion criteria: inclusion criteria:

 Male, aged 18 or older

 Scheduled for Robotic Prostatectomy Surgery

 ASA Classification of I, II, or III

 Good comprehension of written and spoken english.

Exclusion criteria: :

 Allergy to Tetracaine or related anesthetics

 Glaucoma

 Asthma

 History of heart electrical problems

['Visual Acuity', 'Visual Disturbance', 'Intraocular Pressure']

Visual Acuity
Visual Disturbance
Intraocular Pressure


Temperature Control in Central Fever in the Neuro-ICU

Summary: There are few treatments for central fever (fever that is due to the central nervous system, as opposed to an infectious source). We hypothesize that an externally applied cooling blanket will reduce temperature in neurologically ill patients with central fever.
Inclusion criteria: inclusion criteria:

 Two or more days with core temperature ≥ 100.4F

 Approval of the patient's primary attending physician

 Need for core temperature measurement independent of the study.

 Admission to the Neuro-ICU [intensive care unit] for an underlying condition

Exclusion criteria: :

 Evidence for an infectious cause of fever, such as pneumonia, bacteremia, CNS [central nervous system] infection or urinary tract infection.

 Expected death from any cause

 Known sensitivity to the device

 History of pre-admission hypothalamic dysfunction or known temperature dysregulation

 Use of 2 or more vasopressor medications, since this may make a local skin reaction to the device more likely

 Hemodynamic instability

['Gaymar Rapr-Round (external cooling blanket)']


Aerosolized Antibiotics and Respiratory Tract Infection in Patients on Mechanical Ventilation

Summary: The purpose of this study was to determine the effect of aerosolized antibiotics on respiratory infection in mechanically ventilated patients.We hypothesize that aerosolized antibiotics , which achieve high drug concentrations in the airway, would more effectively treat respiratory infection, decrease the need for systemic antibiotics and decrease antibiotic resistance.
Inclusion criteria: inclusion criteria:

 be on mechanical ventilation greater than 3 days

 greater than or equal to 18 years of age survival greater than 14 days

 greater than 2 ccs of tracheal secretions/4 hours

Exclusion criteria: :

 allergy to drugs, pregnancy

['aerosolized vancomycin or gentamicin']

['Ventilator Associated Pneumonia', 'Respiratory Infection', 'Tracheobronchitis']

Ventilator Associated Pneumonia
Respiratory Infection
Tracheobronchitis


The Serotonin Transporter Availability for Prognosing Major Depressive Disorder (MDD) Treatment and Detecting MDD

Summary: Objectives:~To evaluate the relationship between improvement of Hamilton Depression Rating Scale (HAMD) score and basal SERT availability (binding potential) for the prognosis of MDD subjects being treated with Sertraline HCl~To evaluate the SERT availability by means of I-123-ADAM SPECT imaging study for assisting in detecting MDD~To evaluate the relationship between basal HAMD score and basal SERT availability for MDD subjects~To evaluate the relationship between basal HAMD somatic subscale score and basal SERT availability for MDD subjects~To evaluate the relationship between change of SERT availability and change of HAMD score for MDD patients being treated with Sertraline HCl
Inclusion criteria: inclusion criteria:

 - For MDD subjects

 Subject meets the DSM-IV criteria for MDD

 Subject has a minimum score of 18 on the 17-item HAMD total score

 Subject has a minimum score of 2 on item 1, depressed mood, of HAMD

 Subject is free from prior antidepressant medication for at least 5 times of elimination half-lives

 For healthy subjects

 Subject without past or current neuropsychiatric illnesses based on a clinical interview including Mini-International Neuropsychiatric Interview (M.I.N.I.) and a physical examination

 Subject without exposure to psychotropic medication or other substances known to affect the brain serotonin system within 1 year prior to entering the study

Exclusion criteria: :

 Subject with history of any co-morbid neuropsychiatric disease

 Subject with history of treatment resistant to at least two full doses and courses of antidepressant medication

 Subject with history of alcohol or substance dependence or abuse

 Subject with allergic history to the investigational products

 Subject with severe cardiovascular disease or cerebrovascular disease which is judged by investigators for safety concerns as inappropriate for this study

 Subject with malignancy within past 5 years

 Subject with any diseases judged by investigators as inappropriate for this study

 Female subject being pregnant, nursing, or lactating

 Female subject of childbearing potential not using a medically acceptable form of birth control

 Subject is unable to undergo MRI scan to confirm the absence of organic lesion in the brain and to co-register with SPECT images for the delineation of brain anatomical locations

 Subject participated in any investigational drug trial within 4 weeks before entering this study


Identifying Predictors of Bipolar Disorder Relapse During Pregnancy and the Postpartum Period

Summary: This study will evaluate pregnant women who have bipolar disorder to gain a better understanding of risk factors for bipolar disorder relapse during pregnancy and the postpartum period.
Inclusion criteria: inclusion criteria:

 Medically healthy

 Meets DSM-IV criteria for bipolar disorder of any subtype

 No more than 32 weeks gestation, dated by last menstrual period

Exclusion criteria: :

 Active suicidality or homicidality

 Acute psychotic symptoms


Secondary Prevention of Osteoporotic Fractures in Residents of Long-Term Care Facilities

Summary: Osteoporotic fractures of the hip are a major cause of admission to long-term care facilities. Such fractures put patients at high risk for further fractures, pain and disability. Current data show that many patients in long-term care facilities do not receive FDA medications for their osteoporosis. This trial will test whether a multi-model intervention (which provides feedback about provider use of osteoporosis medications, information about osteoporosis, and currently approved osteoporosis medications)directed at physicians, other health care providers, and nurses will improve the number of prescriptions written for FDA approved medications for osteoporosis treatment.
Inclusion criteria: inclusion criteria:

 Any North Carolina long-term care facility with ten residents who had had a hip fracture or osteoporosis diagnosis
Exclusion criteria:

['Long-term care facilities in the intervention arm will receive education and feedback audit on performance']


Phase I Trial of TGFB2-Antisense-GMCSF Gene Modified Autologous Tumor Cell (TAG) Vaccine for Advanced Cancer

Summary: Preliminary studies with a variety of vaccines suggest target accessibility (potential immunogenicity) in a variety of solid tumors to immune directed approaches. However, four primary factors limit the generation of effective immune mediated anticancer activity in therapeutic application:~identifying and/or targeting cancer associated immunogen(s) in an individual patient~insufficient or inhibited level of antigen presenting cell priming and/or presentation~suboptimal T cell activation and proliferation~cancer-induced inhibition of the anticancer immune response in both afferent and efferent limbs.~In an effort to overcome these limitations, we have designed a novel autologous vaccine to address inability to fully identify cancer associated antigens, antigen recognition by the immune system (i.e. antigen to immunogen), effector potency, and cancer-induced resistance. We have completed clinical investigations using two different gene vaccine approaches to induce enhancement of tumor antigen recognition which have demonstrated therapeutic efficacy. Specifically, both the use of a GMCSF gene transduced vaccine and a TGFβ2 antisense gene vaccine, in separate trials, have demonstrated similar beneficial effects without any evidence of significant toxicity in advanced cancer patients. The GMCSF transgene directly stimulates increased expression of tumor antigen(s) and enhances dendritic cell migration to the vaccination site. TGFβ2 blockade following intracellular TGFβ2 antisense gene expression reduces production of immune inhibiting activity at the vaccine site. These agents have never been used in combination but the rationale of integrating enhancement of an anticancer immune response concurrently with a reduction in cancer-induced immune suppression is conceptually sound. We will harvest autologous cancer cells from patients with advanced refractory cancer. We have constructed a TGFβ2 antisense / GMCSF expression vector plasmid and have successfully demonstrated preclinical activity of the vector function following transfection by electroporation and irradiation of autologous cancer tissue.
Inclusion criteria: inclusion criteria:

 Histologically confirmed advanced or metastatic non-curable solid tumor (if limited to a single lesion and not a candidate for curative surgery or radiation therapy).

 Completed ≥1 conventional therapy.

 Clinically indicated surgery or procedure to collect available tumor in sufficient quantity (golf ball size, pleural or ascites fluid may also be collected) for vaccine processing.

 Subjects that have completed all acceptable therapies that are the current standard of care for their respective diseases.

 Recovered from all toxicities related to prior therapies.

 Subjects with brain metastases treated at least ≥2 months prior to enrollment, without related clinical symptoms and must have a stable neurological exam on the screening evaluation.

 ≥1 measurable or evaluable lesion.

 Age ≥18 years.

 ECOG performance status (PS) 0-1.

 Normal organ and marrow function:

 Absolute granulocyte count: ≥1,500/mm3

 Platelets: ≥100,000/mm3

 Total bilirubin: ≤2 mg/dL

 AST(SGOT)/ALT(SGPT): ≤2x institutional upper limit of normal

 Creatinine: <1.5 mg/dL

 Ability to understand and the willingness to sign a written informed consent document.

 Negative pregnancy test.

Exclusion criteria: :

 Surgery involving general anesthesia, chemotherapy, radiotherapy, steroid therapy, or immunotherapy within 4 weeks prior to entering the study.

 Patient must not have received any other investigational agents within 30 days prior to study entry.

 Patients with known brain metastases unless treated and stable for ≥2 months.

 Patients with mucinous adenocarcinoma.

 Short term (<30 days) concurrent systemic steroids ≤ 0.125 mg/kg prednisone per day (maximum 10 mg/day) and bronchodilators (inhaled steroids) are permitted; other steroid regimens and/or immunosuppressives are excluded. Patients requiring steroids following previous CNS radiation for metastatic disease are excluded.

 Prior splenectomy.

 Prior malignancy (excluding nonmelanoma carcinomas of the skin) unless in remission for ≥2 years.

 Kaposi's Sarcoma.

 Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

 Patients who are pregnant or nursing.

 Patients who are HIV positive.

 Patients with chronic Hepatitis B and C infection.

 Patients with a history of autoimmune diseases.

['TGFβ2 Antisense-GMCSF Gene Modified Autologous Tumor Cell (TAG) Vaccine']


Safety and Efficacy of Cryoballoon Ablation of Atrial Fibrillation as First-line Therapy

Summary: Cryoballoon ablation of paroxysmal atrial fibrillation can be used as first-line therapy compared to second choice after failed medical therapy
Inclusion criteria: inclusion criteria:

 paroxysmal atrial fibrillation, symptomatic

Exclusion criteria: :

 atrial fibrillation other than PAF, asymptomatic, previous AF ablation