Pilot Study of the Living With Hope Program for Family Caregivers of Persons With Dementia Residing in Long Term Care

Summary: Hope is important for family/friends of persons with dementia residing in Long Term Care Facilities. Our research team has developed a program (Living with Hope) to increase hope and quality of life of family caregivers. The Living with Hope Program involves a) viewing the Living with Hope film which features caregivers of persons with dementia describing their hope and b) a hope activity entitled Stories of the Present. A new Living with Hope film entitled Connecting with Hope has been produced and will be used in this pilot study. The purpose of this pilot study is to evaluate the feasibility and acceptability of the Living With Hope Program and collect preliminary data on the effectiveness of the Living with Hope Program for family members of persons with dementia residing in Long Term Care.~30 participants will be recruited from St. Joseph's Auxiliary hospital, the Alzheimer's Society of Alberta, and the Alberta Caregivers Association in Edmonton based on inclusion criteria. Participants will be randomly assigned to one of three groups: treatment (Watching a film on hope and Stories of the Present for one month); low dose group (Stories of the Present only); or usual care group. In all groups measures of hope, quality of life, self-efficacy and guild will be collected at visit 1, day 7, day 14 and one month in addition to demographic information. Participants in group 1 and 2 (treatment group) will be asked to describe what they were thinking about when doing the hope activities on day 7, 14 and one month using qualitative interviews. At one month all participants will be interviewed using open ended audio-taped questions to help evaluate the study procedures
Inclusion criteria: inclusion criteria:

 18 years of age and older

 English speaking

 Have a family member or friend with dementia who resides in Long Term Care.

Exclusion criteria: :

 persons who are non-autonomous adults

 cognitively impaired as determined by the Registered Nurse (RN) researcher

 unable to participate, in the opinion of the RN researcher

 non-English speaking

 does not have a family member or friend with dementia in Long Term Care

['Living with Hope Program', 'Stories of the Present']

Living with Hope Program
Stories of the Present


Study of High-flow Oxygen Therapy Against Standard Therapy in Bronchiolitis

Summary: Bronchiolitis is a common illness of the respiratory tract caused by infection of the tiny airways within the lungs called bronchioles. At present the standard care of hospitalized children with bronchiolitis is oxygen via nasal prongs. In this study the investigators would like to compare standard ward management with a new method of delivering oxygen called high flow nasal cannula oxygen therapy (HFNOT). HFNOT involves breathing warmed, moistened oxygen through nasal cannulae at a flow rate of 8 liters/minute. Accumulated experience suggests that HFNOT eases the child's work of breathing and reduces need for ICU admission and invasive respiratory support.
Inclusion criteria: inclusion criteria:

 All children under 18 months of age with a clinical diagnosis of bronchiolitis requiring admission to hospital for observation and oxygen.

Exclusion criteria: :

 Infants admitted directly to ICU from Emergency.

 Prior positive pressure home ventilation.

 Tracheostomy.

 Nasogastric tubes in situ on admission.

 Upper airway abnormality.

 Congenital heart disease.

['High Flow Nasal Cannula Oxygen Therapy', 'Standard low flow oxygen']

High Flow Nasal Cannula Oxygen Therapy
Standard low flow oxygen


Ultrasonography of Chest Versus Pulmonary Artery CT Angiography in Patients With Symptoms and Signs in Favor of PTE

Summary: In this study the investigators compare the diagnostic validity of Bedside Ultrasonography of chest and Pulmonary artery CT Angiography in the patients who came to Emergency Department of Alzahra General Hospital from 1 may 2012 to 1 October 2012 with respiratory symptoms and signs in favor of Pulmonary Thromboemboli (PTE).
Inclusion criteria: inclusion criteria:

 Patients with signs or symptoms in favor of PTE who come to Emergency department of Alzahra General Hospital.

Exclusion criteria: :

 previous history of Allergy to IV contrast

 Serum creatinin more than 1.8

 patients that will not agree to participate in the study.

 pregnancy

 Body weight more than 120 kg

['Pulmonary artery CT Angiography', 'Emergency Bedside Ultrasonography of chest']


The Jackson Heart Study of Cardiovascular Disease Among African Americans

Summary: This is a prospective study of the environmental and genetic factors that influence the development of cardiovascular disease (CVD) in African American men and women. The cohort is a collaboration among multiple institutions (Jackson State University, Mississippi State Department of Health, Tougaloo College, and the University of Mississippi Medical Center), the National Institute on Minority Health and Health Disparities (NIMHD), and the National Heart, Lung, and Blood Institute (NHLBI).
Inclusion criteria: inclusion criteria:

 African American

 Residents of Jackson, Mississippi

Exclusion criteria: :

 Institutionalization

['Cardiovascular Diseases', 'Heart Diseases', 'Atherosclerosis', 'Coronary Disease', 'Hypertension', 'Cerebrovascular Disorders']

Cardiovascular Diseases
Heart Diseases
Atherosclerosis
Coronary Disease
Hypertension
Cerebrovascular Disorders


GENetic & Immunologic Abnomalies in Systemic Lupus Erythematosus

Summary: Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease for which the aetiology includes genet-ic and environmental factors. It is rare in children as compared to adults. The severity may be related to greater involvement of genetic factors in children. The impact of genetics in the development of SLE is important, and the risk of recurrence in siblings evaluated by lambda S ratio is 30 in SLE, while it is 15 for type-1 diabetes and 8 rheumatoid arthritis, thereby indicating high impact of genetics in SLE.~Recently, the group of Professor Yanick Crow in Manchester and other teams has identified new forms of lupus Mendelian genetics. The TREX1 and genes involved in the SAMHD1 frostbite lupus.~Nearly 2 % of all adult subjects with SLE have a heterozygous mutation in the TREX1 gene, which therefore represents the first genetic cause of SLE. The team of Professor Crow also identified the ACP5 gene that is responsible for SLE associated with Spondylo-epiphyseal enchondro-epiphyseal dysplasia (syndromic lupus). Other groups have identified mutations in two genes encoding a DNAse (DNAse1 and DNAse1L3) responsible for familial monogenic forms of SLE. These new genes SLE were identified through research of germ-line mutations in cases of lupus syndromic or family. In collaboration with Professor Crow, we are currently undergoing characterization of a novel gene of SLE in a family and we have identified a second locus identified in another family. The identification of these genes provides a better understanding of the mechanisms regulating immune tolerance in humans. The frequency of these genetic forms is not known. There is very little data on the immunological phenotype of these patients.~This is a clinical study to investigate the genetic and immunological abnormalities associated with pediatric SLE. The aim are to:~study the genetics of pediatric SLE (or syndromic or family) and to search for mutations in the known genetic lupus or new genes in collaboration with Professor Yanick Crow.~study the lymphocyte subpopulations and serum cytokines in pediatric patients with SLE (or syndromic or family) in the large Rhône- Alpes- Auvergne area.
Inclusion criteria: inclusion criteria:

 Male or female subject, major or minor of any age with SLE (defined according to the ACR criteria)

 Onset pediatric (<18 years) OR

 Syndromic Lupus (associated with growth retardation, neurological deficit not related to lupus, frostbite, lymphoproliferation, the kidney malformations, heart, lung, brain calcifications) OR

 Lupus in context with familial consanguinity OR

 Familial cases (2 cases of SLE related first degree relative) OR related topic of the first degree to a lupus patient participant (if family lupus or related parents) OR

 mother/father's lupus patient (in cas of simplex lupus)

 A person or beneficiary entitled to a social security scheme or similar

 Informed consent signed by the person (or parent / holding parental authority for minors)

Exclusion criteria: :

 - none


Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of ACT-389949

Summary: This is a prospective, single-center, double-blind, randomized, placebo-controlled, ascending single oral dose and food interaction Phase 1 study. It will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending single oral doses of ACT-389949 in healthy male subjects. It will also investigate the effect of food on the pharmacokinetics, safety, and tolerability of a single dose of ACT-389949.
Inclusion criteria: inclusion criteria:

 Signed informed consent prior to any study-mandated procedure.

 Healthy Caucasian male subjects aged between 18 and 45 years (inclusive) at screening.

 Subjects must agree to use reliable methods of contraception.

 No clinically significant findings on physical examination at screening.

 Body mass index (BMI) between 18.0 and 30.0 kg/m^2 (inclusive) at screening.

 Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate (PR) 45-90 bpm (inclusive) measured at screening.

 12-lead ECG without clinically relevant abnormalities, measured at screening.

 Body temperature (T°) 35.5-37.5°C at screening and prior to (first) dosing.

 Total and differential white blood cell (WBC) count strictly within the normal ranges at screening and on Day -1.

 C-reactive protein (CRP) levels below 5 mg/L.

 Hematology and clinical chemistry results (other than total and differential WBC count and CRP) not deviating from the normal range to a clinically relevant extent at screening.

 Coagulation and urinalysis test results not deviating from the normal range to a clinically relevant extent at screening.

 Non smokers, defined as never smoked or achieved cessation for ≥ 6 months at screening.

 Negative results from urine drug screen at screening.

 Subjects allowing the conduct of genetic analyses on whole blood consisting of measuring the levels of messenger ribonucleic acid (mRNA) expression of mechanistic biomarkers of N-formyl-peptide receptor 2 (FPR2) and proteins involved in inflammation.

 Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study.

Exclusion criteria: :

 Known allergic reactions or hypersensitivity to any excipient of the drug formulation.

 History or clinical evidence of any disease, and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drug.

 Previous history of recurrent fainting, collapses, syncope, orthostatic hypotension, or vasovagal reactions.

 Veins unsuitable for intravenous (i.v.) puncture on either arm.

 Treatment with another investigational drug within 3 months prior to screening or having participated in more than four investigational drug studies within 1 year prior to screening.

 History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.

 Excessive caffeine consumption.

 Treatment with any prescribed or over-the-counter (OTC) medications within 2 weeks prior to (first) study drug administration or five half-lives of the medication, whichever is longer.

 Any history of immunosuppressive treatment.

 Chronic diseases including those with recurring periods of flare-ups and remission.

 History of atopic allergy (including asthma, urticaria, eczematous dermatitis).

 Signs of infection (viral, systemic fungal, bacterial or protozoal) within 4 weeks prior to (first) study drug administration.

 History of acute or chronic obstructive lung disease (treated or not treated).

 History of subarachnoid hemorrhage or hemolytic uremic syndrome.

 Interval from the beginning of the P wave to the beginning of the QRS complex (PQ/PR interval) < 120 ms at screening.

 Loss of 250 mL or more of blood, or an equivalent amount of plasma, within 3 months prior to screening.

 Positive results from the hepatitis serology, except for vaccinated subjects or subjects with past but resolved hepatitis, at screening.

 Positive results from the human immunodeficiency virus serology at screening.

 Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

 Legal incapacity or limited legal capacity at screening.


A Short Metaphyseal Fitting Total Hip Arthroplasty in Young and Elderly Patients

Summary: The investigators determined whether~new short, metaphyseal-fitting cementless anatomical femoral stem provides major functional improvements~radiographically secure implant fixation is achieved with this new stem~the bone content is preserved at the baseline level or above at the final follow-up~these procedures are associated with early failure and complications.
Inclusion criteria: inclusion criteria:

 Osteoarthritis of hip joint requiring total hip arthroplasty

Exclusion criteria: :

 Neurologic disorders affecting motor function of lower extremity foot and ankle disorders limiting ambulation of the patient

 Patients with bone metabolic disorders other than osteoporosis which prevents normal bone metabolism

 Multi-systemic inflammatory arthritis which debilitates patients other than hip joint.


Safety and Immunogenicity Study of Influenza Vaccines in HIV-infected and HIV-uninfected Pregnant Women in Western Kenya

Summary: In 2012, the WHO Strategic Advisory Group of Experts (SAGE) concluded that pregnant women are the most important risk group for season influenza vaccination based upon compelling evidence of substantial risk of severe disease in this group and evidence that seasonal influenza vaccine is safe and effective in preventing disease in pregnant women as well as their young infants, in whom disease burden is also high. Recent data from Kenya, similarly suggest rates of influenza-associated hospitalizations in children under age 1 to be as high, or higher, than those observed in the United States. However, TIV may have reduced immunogenicity in HIV-infected adults, and HIV infection has been shown to reduce placental transfer of both tetanus and measles antibodies. Therefore, we propose to conduct a double-blind randomized controlled trial of influenza vaccines stratified by HIV status in up to 720 pregnant women in their second and third trimesters and their infants residing in health and demographic surveillance sites (HDSS) in Nyanza Province, Western Kenya. We propose to assess the safety, immunogenicity, and efficacy of standard dose QIV and double dose QIV in HIV-infected and HIV-uninfected pregnant women. Findings will inform maternal influenza vaccination policies in Kenya and other African countries.
Inclusion criteria: inclusion criteria:

 Resident of HDSS village

 Singleton pregnancy

 Second or third trimester (after quickening) but before 33 weeks of gestation by fundal height

 Does not plan to relocate out of the HDSS area or population-based surveillance site in the next 12 months and agrees to all follow-up visits/contact by phone

 Is not currently enrolled in another intervention study

 Provides informed consent by signature or thumb print

 Consents to HIV testing and counseling as required

 Willing to deliver in the labor ward of the study hospital

 No history of chronic illness requiring multiple hospitalizations or prolonged medical therapy (except HIV on ART)

Exclusion criteria: :

 History of allergic reaction to any component of the study vaccines

 Residence outside the study area or planning to relocate out in the 9 months following enrollment

 Received immunoglobulin or blood products within 45 days of study entry

 Used immunosuppressive medication within 45 days of study entry (inhaled and topical corticosteroids permitted)

 High risk pregnancy including any pre-existing condition likely to cause complications of pregnancy (hypertension, diabetes, current asthma, eclampsia or pre-eclampsia, epilepsy, heart disease, renal disease, liver disease, fistula repair, leg or spine deformity)

 Unable to give informed consent (for example due to mental disability)

 Previous enrollment in a study with similar interventions

 Gestational age >32 weeks by last menstrual period or fundal height

 Acutely ill with temperature ≥37.5°C on the day of randomization/vaccination

 Hemoglobin <7.0 g/dL

 Influenza vaccination in previous 12 months

['Quadrivalent Inactivated Influenza Vaccine (QIV)', 'Inactivated Polio Vaccine', 'Double Dose QIV']

['Influenza, Human', 'HIV', 'Malaria', 'Tetanus', 'Polio']

Influenza Human HIV Malaria Tetanus Polio


Safety of and Immune Response of a 2-dose Regimen of rDEN1delta30 Dengue Virus Vaccine

Summary: Dengue fever, caused by dengue viruses, is a major health problem in tropical and subtropical regions of the world. The purpose of this study is to evaluate the safety of and immune response to a 2-dose regimen of a new monovalent dengue virus vaccine. This study will test the dengue virus vaccine DEN1delta30 in healthy adults.
Inclusion criteria: inclusion criteria:

 Good general health

 Available for the duration of the study (23 weeks for Cohort 1 and 32 weeks for Cohort 2)

 Willing to use acceptable forms of contraception for the duration of the study

Exclusion criteria: :

 Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease

 Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, may interfere with the study

 Significant laboratory abnormalities

 Medical, work, or family problems as a result of alcohol or illegal drug use within 12 months prior to study entry

 History of severe allergic reaction or anaphylaxis

 Severe asthma

 HIV-1 infected

 Hepatitis C virus (HCV) infected

 Hepatitis B surface antigen positive

 Known immunodeficiency syndrome

 Use of corticosteroids or immunosuppressive medications within 30 days prior to study entry. Individuals using topical or nasal corticosteroids are not excluded.

 Previous receipt of a live vaccine within 4 weeks prior to study entry

 Previous receipt of a killed vaccine within 2 weeks prior to study entry

 Absence of spleen

 Previous receipt of blood products within 6 months prior to study entry

 Previous receipt of dengue virus or other flavivirus (e.g., yellow fever virus, St.Louis encephalitis, West Nile virus) infection

 Previous receipt of yellow fever or dengue vaccine

 Plans to travel to an area where dengue infection is common

 Previous receipt of any investigational agent within 30 days prior to study entry

 Other condition that, in the opinion of the investigator, would affect participation in the study

 Pregnant or breastfeeding


Iron Supplementation in Schistosomiasis and Soil Transmitted Helminths Control Programmes in Zambia

Summary: The objectives of this study is:~to establish the coverage rate of weekly iron supplementation in children in intervention schools over a period of nine months~document any side effects of weeekly iron supplementation among children in intervention schools over a period of nine months asses the feasibility of incorporating the weekly iron supplementation programme into the normal school activity in intervention schools determine the extent of acceptability and support for the iron supplementation programme by staff at the health centre nearest to the intervention schools~compare the praziquantel efficacy and schistosomiasis reinfection in children in intervention schools with that of children in control schools following the introduction of weekely iron supplementation over a period of nine months~determine the impact of weekly iron supplementation on haemoglobin levels of children in intervention schools and compare with children in control schools over a period of nine months
Inclusion criteria: inclusion criteria:all schoolchildren, in grade 2 and 3, at four selected schools -

Exclusion criteria: :

 -


Pilot Study of Enalapril and Renal Function in Patients With IgA Nephropathy

Summary: OBJECTIVES: I. Determine the most sensitive outcome measures (functional or morphological) of a progressive renal injury in patients with IgA nephropathy.~II. Determine which of these patients are destined to progress to further injury in order to target them for therapy.~III. Elucidate the determinants of progression in those patients who exhibit evidence of either increasing impairment of ultrafiltration capacity or ongoing destruction of nephrons.
Inclusion criteria: Histologically confirmed IgA nephropathy, diagnosed within the past 3 years

 Clinical presentation of either isolated hematuria/proteinuria for less than 3 years OR

 Acute nephritic or nephrotic syndrome

 No secondary forms of IgA nephropathy associated with chronic inflammatory disease of the bowel and liver

 No end stage renal failure as defined by the following: Glomerular filtration rate less than 15 mL/min AND Extensive glomerulosclerosis and tubulointerstitial damage

 No systemic lupus erythematosus or systemic (extrarenal) vasculitis (Henoch-Schonlein syndrome)

 Healthy volunteers will be accrued as a control group

 No other concurrent medical or psychiatric illness that would preclude study
Exclusion criteria:


The Efficacy of Vitamin K2 n Human Osteoporosis, Blood-vessel Calcification and Sclerosis

Summary: This study used the generally recognized as safe (GRAS) grade of Bacillus subtilis natto to produce Vitamin K2, Menaquinone-7(MK-7), via fermentation, for functional evaluation. There are four major objectives for this study: (1) bioavailability of calcium; (2) evaluation of bone density improvement; (3) evaluation of blood-vessel calcification and sclerosis improvement; (4) safety evaluation.
Inclusion criteria: inclusion criteria:

 Men and non-pregnant women who are at least 20 years and under 75 years of age; and

 Female subjects cannot be pregnant or breast feeding.

 Patients who are, in the opinion of the Investigator, able to comply with the requirements of the study; and

 Patients who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving study medication.

Exclusion criteria: :

 Women who are pregnant, as determined by a urine pregnancy test, or breast-feeding.

 Presence or history of congestive heart failure (NYHA class III/IV) within the prior 12 weeks.

 Recent myocardial infarction (within the prior 12 weeks).

 Unstable angina pectoris.

 Known or suspected renal insufficiency defined as creatinine>1.5mg/dl.

 Known or suspected hepatic insufficiency defined as abnormal liver function tests (GOT/GPT) >3x upper normal limit (i.e., 120 U/l).

 Known hypomotility syndrome: (such as hypothyroidism or scleroderma).

 Recent major trauma within the prior 12 weeks.

 Recent surgery requiring anesthesia including coronary artery bypass graft (within 12 weeks).

 Recent hospitalization (within 12 weeks)

 Uncontrolled hypertension (defined as a systolic blood pressure>180mmHg or a diastolic blood pressure >105mmHg).

 Uncontrolled hyperlipidemia (defined as total cholesterol>240mg/dL or triglyceride >200mg/dL).

 Uncontrolled diabetes (defined as HbA1c>7%).

 Cigarette smoker (>=1/day).

 Acute infection requiring current antibiotic therapy.

 Current use of anticoagulant medication (e.g., warfarin).

 Recent or abrupt change (within 1 month) in usual diet.

 Use of an investigational drug (within 30 days prior to enrollment).

 Known allergies to the component of study medication

 Patients have acute disease, and in the opinion of investigators, are not suitable to participate in this study.

['Vit K2+ Vit D3+ calcium carbonate (CaCO3)', 'Vit K2+CaCO3']


Diagnostic Value of Lung Ultrasound for Ventilator-Associated Pneumonia

Summary: Ventilator-associated pneumonia (VAP) is the most common nosocomial infection acquired by mechanically-ventilated patients in the intensive care unit (ICU). It has significant clinical and economic consequences, as it is associated with considerable morbidity, increased mortality, and excess health care costs. Appropriate antibiotic therapy for patients with VAP significantly improves outcomes, making rapid identification of patients with VAP an important clinical goal.~This application is for support of a prospective, multi-centered study to evaluate the diagnostic value of lung ultrasound for VAP. The primary hypothesis is that the association of the Clinical Pulmonary Infection Score (CPIS) to specific lung ultrasound signs could allow for early and reliable diagnosis of bacterial VAP.~Objective 1: To evaluate the sensitivity, specificity, and diagnostic accuracy of lung ultrasound alone and in association with the CPIS.~Objective 2: To determine the frequency of specific lung ultrasound signs (subpleural consolidation, irregular B-lines) in VAP.~Objective 3: To promote development of a diagnostic pathway for VAP incorporating CPIS, lung ultrasound, and unprotected tracheal aspirate (UTA).
Inclusion criteria: inclusion criteria:

 Mechanical ventilation for at least 48 hours,

 New or evolving infiltrate on chest radiograph (CXR) or computed tomography (CT), and

 A minimum of two of the following clinical criteria:

 Body temperature ≥ 38.5° C (101° F) or < 36° C (97° F)

 White blood cell count > 10,000/ml or < 4,000/ml or > 10% immature cells

 Partial pressure of oxygen in arterial blood < 60 mmHg or partial pressure of oxygen in arterial blood/ inspired oxygen fraction ratio < 300

 Purulent respiratory secretions

Exclusion criteria: :

 Known ongoing pneumonia

 Patient younger than 18 years old

 Mechanical ventilation <48 hours

 Contraindication to bronchoscopy


Retrospective Analysis of the Safety and Efficacy of Hydroxychloroquine in Immune Thrombocytopenia

Summary: Retrospective study of the safety and efficacy of hydroxychloroquine among patients with immune Thrombopenia (ITP).
Inclusion criteria: inclusion criteria:

 Patients older than 18 years old

 Immune Thrombopenia according to the American Society of Hematology (ASH) guidelines 2011

 Positive antinuclear antibodies > 1/160e on Hep2 cells

Exclusion criteria: :

 Secondary ITP (eg HIV, HCV, HBV, lymphoproliferative disorders...)

['Immune Thrombocytopenia', 'Systemic Lupus Erythematosus']

Immune Thrombocytopenia
Systemic Lupus Erythematosus


Analysis of the Status, Treatment and Outcomes of Rib Fractures

Summary: A retrospective analysis of all patient presenting with multiple rib fractures to the emergency room of Penn State Hershey Medical Center between 2010-2012. Patient demographics, cause of fracture, outcomes, chronic medical conditions, vital signs, length of stay, pain levels and treatment, and sequelae will be recorded and analyzed.
Inclusion criteria: inclusion criteria:

 must have above and be notated in our medical record

Exclusion criteria: :

 missing data


The MASS COMM Post-Randomization Phase Cohort Study

Summary: The primary objective of the Post-Randomization Phase Cohort Study is to continue to assess the safety of non-emergency PCI performed at hospitals without cardiac surgery on-site in patients with myocardial ischemia (other than ST-segment elevation myocardial infarction [STEMI]).
Inclusion criteria: inclusion criteria:

 Candidates for this study must meet ALL of the following criteria:

 Subject is at least 18 years old.

 Subject requires single- or multi-vessel percutaneous coronary intervention (PCI) of de novo or restenotic target lesion (including in-stent restenotic lesions). N.B. staged procedure will not be considered to meet the endpoint component of repeat revascularization if either of the following pre-catheterization procedure qualifying clinical laboratory values are met:

 eGFR is less than 60 ml/min or

 creatinine is greater than 1.5 mg/dl

 Subject's lesion(s) is (are) amenable to stent treatment with currently available FDA-approved bare metal or drug eluting stents.

 Subject is an acceptable candidate for non-emergency, urgent or emergency CABG.

 Subject has clinical evidence of ischemic heart disease in terms of a positive functional study, or documented symptoms.

 Documented stable angina pectoris [Canadian Cardiovascular Society Classification (CCS) 1, 2, 3, or 4], unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), non-ST segment elevation myocardial infarction, or documented silent ischemia.

 Subject and the treating physician agree that the subject will comply with all follow-up evaluations.

 Subject has been informed of the nature and purpose of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site.

 Angiographic inclusion criteria

 The target lesion(s) is (are) de novo or restenotic (including in-stent restenotic) native coronary artery lesion(s) with greater or equal to 50 and less than 100% stenosis (visual estimate), or the target lesion is an acute (less than 1 month) total occlusion as evidenced by clinical symptoms.

 If Fractional Flow Reserve (FFR) is measured, target lesion(s) has (have) evidence of a hemodynamically significant stenosis determined by FFR measurement (FFR less than or equal to 0.8).

 Target lesions(s) is (are) located in an infarct (if not treated with primary PCI) or non-infarct-related artery with a 70% or greater stenosis (by visual estimate) greater than 72 hours following the STEMI.

 Lesions treated with PCI greater than 72 hours following STEMI would be subject to the same protocol inclusion/
Exclusion criteria:  listed above and below with the exception that a target lesion of 70% or greater stenosis may be treated with or without symptoms or abnormal stress test).


Carbetocin at Elective Cesarean Delivery Part 4

Summary: PostPartum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most commonly used uterotonic drug to prevent and treat PPH in North America. However oxytocin has a very short duration of action, requiring a continuous infusion to achieve sustained uterotonic activity. Moreover large doses are associated with adverse effects like hypotension, nausea, vomiting, dysrhythmias and ST changes. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recommended a single dose of 100 mcg of carbetocin at elective cesarean delivery to promote uterine contraction. In three studies recently performed at Mount Sinai Hospital, the investigators have found no difference in uterine contractility between the doses of 20- 120 mcg carbetocin and that the ED90 is 14.8 mcg. Thus a larger trial comparing the minimum effective dose determined in the previous three trials with the standard 100 mcg dose is necessary to confirm these findings.
Inclusion criteria: inclusion criteria:

 Elective cesarean delivery under spinal anesthesia.

 Written informed consent to participate in this study.

 Term pregnancy

Exclusion criteria: :

 Refusal to give written informed consent.

 Allergy or hypersensitivity to carbetocin or oxytocin.

 Conditions that predispose to uterine atony and postpartum hemorrhage, such as placenta previa, multiple gestation, preeclampsia, eclampsia, macrosomia, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, or bleeding diathesis.

 Hepatic, renal, and vascular disease.


Study of Purified Vero Rabies Vaccine Serum Free Compared With Reference Purified Vero Rabies Vaccine in Healthy Adults

Summary: The purpose of this study is to generate data in human on immunogenicity and safety of Purified Vero Rabies Vaccine (VRVg) in support of the vaccine registration.~Primary Objective:~To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab, in terms of seroconversion rate at Day 42 of the primary vaccination series.~Secondary Objectives:~To assess the clinical safety of VRVg after each vaccination when administered in a pre-exposure vaccination schedule with a booster at 12 months after the first vaccination in all subjects.~To describe the immune response induced by VRVg 21 days after two vaccinations in a subset of randomized subjects and 14 days after the last vaccination of the primary vaccination series.
Inclusion criteria: inclusion criteria :

 Aged 18 to 60 years on the day of inclusion

 Provision of a signed Informed Consent Form

 Able to attend all scheduled visits and comply with all trial procedures

 For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence for at least 4 weeks prior to each vaccination, until at least 4 weeks after each vaccination)

 Entitlement to national social security

Exclusion criteria:  :

 For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test

 Breast-feeding woman

 Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination

 Planned participation in another clinical trial during the present trial period

 Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy

 Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances

 Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator

 Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures

 Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response

 Receipt of any vaccine in the 4 weeks preceding the first trial vaccination

 Planned receipt of any vaccine in the 4 weeks following any trial vaccination

 Known human immunodeficiency virus (HIV), Hepatitis B surface (HBs) antigen, or Hepatitis C seropositivity

 Previous vaccination against rabies with any vaccine (in pre- or post-exposure regimen)

 Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination

 Subject at high risk for rabies exposure during the trial period

 Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent

 Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.

 Study site employee who is involved in the protocol and may have direct access to trial related data.

['Purified Vero Rabies Vaccine - Serum Free', 'Purified inactivated rabies vaccine']


Pressure-Sensing Insoles in the Neuropathic Ulcer Treatment Pathway

Summary: Diabetic foot ulceration (DFU) is a common complication with a 25% lifetime risk in patients with diabetes. While most of these ulcers can be treated successfully on an outpatient basis, some will persist and become infected. Nearly one fifth of patients with lower-extremity diabetic ulcers will require amputation of the affected limb, resulting in staggering costs for both the patient and the healthcare system. Therapies that promote rapid and complete healing and reduce the need for expensive surgical procedures impact these costs substantially.~The standard of care for the treatment of diabetic foot ulcers is the removable cast walker (RCW). RCW use has demonstrated plantar pressure reduction yet is typically perceived as having compliance issues due to its removable nature. In addressing this limitation, a modified version of the RCW has been developed by wrapping it in a layer of cohesive or plaster bandage. This technique has been termed the instant total contact cast (iTCC) derived from the seldom-used, gold standard treatment, the total contact cast (TCC). While ease of application and potential clinical equivalence are clear benefits, the iTCC carries disadvantages on account of its irremovability. For example, frequent dressing changes impractical, yet may be necessary for complex wound care. The goal of this research is to continue inquiry and innovation in this most basic aspect of care, whilst addressing the limitations of past research and failures in this domain.~The investigators propose examining the capability of the SurroSense Rx® smart insole and smartwatch system (Orpyx Medical Technologies Inc., Calgary AB) in managing and monitoring adherence to plantar pressure offloading through alert-based feedback. The insoles are embedded with pressure sensors, which wirelessly communicate with a smartwatch that provides feedback on modifying activity or pressure profile over time. This smartwatch transmits audio, visual, and tactile notifications when excessive pressure-time thresholds under plantar regions of interest have been met. This feedback allows patients to be educated on their plantar pressure, and engages them and their caregivers to manage adherence to offloading. The investigators also propose comparing the healing rates of active neuropathic ulcers using RCWs coupled with the SurroSense Rx® smart insole system to assess whether adjunctive use of the two interventions improves the efficiency of neuropathic ulcer treatment.
Inclusion criteria: inclusion criteria:

 Diabetes (according to AAFP diagnostic criteria )

 Presence of neuropathy with Loss of Protective Sensation (LOPS), as defined by any loss of sensation as per the assessments included in the Modified Neuropathy Disability Score (MNDS)

 Active plantar diabetic foot ulcer (Grade 1A, according to the University of Texas Wound Classification System , )

 A minimum size ulcer ≥0.5cm2 and ≤ 12 cm2 post debridement at time of randomization

 If the subject has more than one ulcer, they should be identified and at least 2 cm apart

 Age >18

 At least one palpable foot pulse

 Ability to understand all of the study requirements

 Life expectancy greater than the duration of the study

 Subject or responsible caregiver is willing and able to maintain the required offloading (as applicable for the location of the ulcer) and applicable dressing changes

 Doppler Ultrasound positive for at least one pedal pulse in each foot

Exclusion criteria: :

 Weight > 400 lb (182 kg)

 Uncorrected visual impairment

 Active Infection

 Non-plantar ulcers on the ankle, posterior heel, or other location

 More than one active plantar ulcer

 Presence of severe ischemia (any of: absence of foot pulses, Ankle Brachial Index 0.6 > [ABI] > 1.2, capillary refill time > 5 seconds; see Appendix 3)

 Current participation in another clinical investigation of a medical device or a drug; or has participated in such a study within 30 days prior to this study

 Current smokers

 Active abuse of alcohol

 o Subject has a history of any of the following intercurrent illnesses or conditions that would compromise the safety of the subject or the normal healing process:

 End-stage renal disease

 Immunosuppression

 Severe malnutrition

 Liver disease

 Aplastic anemia

 Scleroderma

 Acquired immune deficiency disease (AIDS) or HIV positive

 Connective tissue disorder

 Exacerbation of sickle cell anemia

 Active Charcot foot

 Excessive lymphedema

 Osteomyelitis and gangrene

 Subjects with ulcers secondary to a disease other than diabetes (e.g. vasculitis, neoplasms or haematological disorders)

 o At the end of the run-in period and prior to randomization, the subject be excluded if the following conditions are not met:

 Subject does not continue to meet the entrance criteria (inclusion and exclusion)

 The size of the study ulcer, following debridement, has decreased by more than 30% from the baseline assessment measured at screening.

 Abnormal toe and/or ankle range of motion

['Diabetes', 'Diabetes Complications', 'Neuropathy', 'Peripheral Neuropathy', 'Diabetic Foot Ulcer']

Diabetes
Diabetes Complications
Neuropathy
Peripheral Neuropathy
Diabetic Foot Ulcer


Bone Density in Patients With Schizophrenia

Summary: People with chronic mental disorder such as schizophrenia and alcohol abuse are high risk groups for developing osteoporosis.~To evaluate the prevalence of bone mineral density in men patients with schizophrenia with alcohol abuse, the investigators will compare bone mineral density between patient with schizophrenia with and without alcohol abuse.
Inclusion criteria: inclusion criteria:

 DSM-IV diagnosis of schizophrenia

 Onset of illness more than 5 years.

Exclusion criteria: :

 No severe Medical and endocrinological disorder


Antibiotic or Not in Non-purulent Exacerbations of COPD: a Trial of Security and Efficacy

Summary: COPD is one of the most important causes of morbidity and mortality and supposes a sanitary problem in Europe and USA. Patients with COPD usually have 1-2 episodes of acute exacerbation of COPD (AECOPD) per year, being these the principal causes of of hospitalizations, respiratory problems and medical visits. After an episode of AECOPD, the majority of patients develop a transitory (or permanent) worsening in their quality of life and 50% of them will require a new hospitalization. Globally, a 75%& of the exacerbations might be associated with a respiratory tract infection, and among them, 50% might be related to bacteria and in 45% an evidence of viral infection could be documented. Even though the antibiotic treatment might not be useful for a majority of patients with AECOPD, is generalized its use(almost an 85% in some series) in hospitalized patients. The non-controlled use of antibiotics in AECOPD results in a very expensive disease and raises the rate of resistance of bacteria. The available literature have shown that there's a relation between exacerbations and infections, based on sputum samples.~In summary, is well known that at least a 50% of the episodes of AECOPD might be associated with pathogenic bacteria in the lower respiratory tract. Prescription of antibiotics is wide and generalized in hospitalized patients. Clinical trials have shown correlation between AECOPD with sputum purulence (which correlates with presence of bacteria), however they've not included NON-purulent AECOPD, even though they're a significative group of patients hospitalized by this cause too. It's necessary to evaluate the efficacy nor the security of antibiotic treatment in this group of patients in a well designed trial.
Inclusion criteria: inclusion criteria:

 COPD diagnosis according to GOLD guidelines

 Hospitalization for any acute exacerbation of chronic obstructive pulmonary disease

 Failure of outpatient treatment

 Increasing of dyspnea in the last days

 Comorbidity that causes detriment of respiratory function

Exclusion criteria: :

 Life expectancy of less than 6 months

 Mechanical Ventilation

 Cardiovascular condition that causes exacerbation

 Immunosuppression

 Pulmonary infiltrates that suggest pneumonia

 Antibiotic treatment in the last month

 Pregnancy

 ECG with a large QT segment

 Hypokalemia

 Hepatic failure or renal failure

['Chronic Obstructive Pulmonary Disease']


Diffusion of Use of Low Molecular Weight Heparin for Thrombosis on the Medicine Services

Summary: The purpose of this research is to gain insight into the way in which physicians adopt new practice techniques. In particular, we are interested in how medical innovations diffuse throughout social networks. We wish to examine the diffusion of Low Molecular Weight Heparin (LMWH) use for Deep Vein Thrombosis (DVT) throughout the social network of general internal medicine interns, residents, and attendings at the University of Chicago Hospital. In numerous clinical trials, LMWH has been demonstrated to be as effective as unfractionated heparin as a bridge to long-term anticoagulation therapy with Coumadin, with the added benefit of early discharge from the hospital with easy dosing, no need for monitoring, and home therapy. A DVT critical pathway was established at the U of C in 1998, and LMWH was used off-label for that purpose beginning in 1997. However, it is unclear how quickly the use of LMWH was adopted by the physicians on the general medicine services, or whether there exists a pattern for this adoption.
Inclusion criteria: inclusion criteria:

 Patients admitted to General Medicine Services with a primary or secondary diagnosis related to venous thromboembolism

Exclusion criteria: :

 Non-General Medicine Services patients


Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia

Summary: In order to determine the efficacy and safety of thyroxine replacement, a randomized clinical trial of thyroxine supplementation for VLBW infant with hypothyroxinemia during the first month of age is conducted.
Inclusion criteria: inclusion criteria:

 Birth weight: less than 1500g

 Gestation: 22 weeks 0 day ≤

 Serum free thyroxine level lower than 0.8 ng/dl

 Serum thyrotropin lower than 10 μU/ml

 Age of between 2 and 4 weeks after birth

 Informed consent

Exclusion criteria: :

 any known thyroid disease in mother


Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients With Acute Exacerbation of Bronchiectasis

Summary: The therapy of bronchoalveolar lavage and local amikacin injection as one of the treatment of bronchiectasis developed in recent years.this study is aim to evaluate the Clinical Efficacy and Safety of Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients with Acute Exacerbation of Bronchiectasis.
Inclusion criteria: inclusion criteria:

 Age≥18 years and ≤80 years;

 Patients with non-cystic fibrosis bronchiectasis diagnosed by high-resolution CT;

 Are sensitive to amikacin;

 Acute exacerbation of bronchiectasis;

 Capable of the completion of bronchoscopy, alveolar lavage, pulmonary function testing etc;

 Willing to join in and sign the informed consent form.

Exclusion criteria: :

 Active bleeding without control；

 Receiving nasal or facial surgery recently；

 With severe cardio-pulmonary dysfunction, such as left heart failure, unstable arrhythmia, etc.

 With other respiratory diseases: such as active pulmonary tuberculosis, non-tuberculosis mycobacteria (NTM) pulmonary disease, pulmonary aspergillosis, etc.

 Be allergic to amikacin

['Bronchoalveolar Lavage and Local Amikacin Injection']


Immunopathogenesis of Chlamydia

Summary: Sexually transmitted Chlamydia trachomatis infections are a widespread public health concern due to their prevalence and potentially devastating reproductive consequences, including pelvic inflammatory disease, infertility, and ectopic pregnancy. The goal of this study is to evaluate the risk factors for adverse outcomes following genital tract infection with Chlamydia trachomatis and to evaluate whether or not the presence of C. trachomatis in the rectum act as a reservoir for infection.
Inclusion criteria: inclusion criteria:

 Female

 11 to 21 years of age at the time of enrollment

 Positive for Chlamydia infections by urine or cervical PCR

 5th Chlamydia-negative subject who fits all other inclusion criteria

 Negative pregnancy test

 Written informed consent provided

 Signed a HIPAA authorization form

 Willingness to comply with all the requirements of the protocol

Exclusion criteria: :

 Positive pregnancy test

 Negative for Chlamydia, unless 5th negative subject to be in the control group

 Any condition that in the opinion of the investigator would interfere with the ability of the potential subject to complete the study or would result in significant risk to the subject


Non-cardiac Chest Pain Evaluation and Treatment Study (CARPA) - Part 1: Diagnosis.

Summary: The overall aim of the project is to evaluate diagnosis and treatment of chest pain originating from the musculoskeletal system. Specifically, we wish to investigate prevalence and character of such chest pain in a population of patients with acute chest pain, admitted to a university hospital based acute chest pain clinic, and undergoing evaluation of acute coronary syndrome (Part 1). Then, to test a manually-based treatment protocol to patients with diagnosed musculoskeletal chest pain in a randomized clinical trial (Part 2).~The specific purpose of this study (Part 1) is to determine the exact number of patients with acute chest pain origination from the musculoskeletal system, and to describe their cardiac status with respect to ischemic heart disease. Further, we wish to evaluate the decision making process of the chiropractor.
Inclusion criteria: inclusion criteria:

 Acute episode of chest pain of less than 7 days duration as primary reason for admission to a chest pain clinic.

 Admitted to a chest pain clinic, suspected of acute coronary infarction, but with a negative diagnosis confirmed by normal coronary enzymes and normal ECG.

 Pain arising from the thorax and/or neck.

 Able to read and understand Danish.

Exclusion criteria: :

 Acute coronary syndrome.

 Percutaneous Coronary Intervention.

 Coronary Artery Bypass Grafting.

 Other disease, diagnosed during this admission, which is likely to have caused the acute episode of chest pain.

 No written consent.

 Inflammatory joint disease.

 Diabetes mellitus, type I.

 Fibromyalgia.

 Sharp trauma to the chest.

 Malignant disease.

 Apoplexy.

 Gross osseous anomalies, such as pronounced scoliosis.

 Known or suspected osteoporosis.

 Pregnancy.

 Dementia/unable to cooperate.

 Not residing in the County of Funen.

 Does not want to participate.

 Other - reason for exclusion will be noted.

['Non-Cardiac Chest Pain', 'Undiagnosed Chest Pain', 'Musculoskeletal Chest Pain', 'Ischemic Heart Disease']

Non-Cardiac Chest Pain
Undiagnosed Chest Pain
Musculoskeletal Chest Pain
Ischemic Heart Disease


Low-Dose Hormone Replacement Therapy and Alendronate for Osteoporosis

Summary: Osteoporosis, a condition in which bones are fragile and break easily, is a major health problem for postmenopausal women. Research studies have shown that both estrogen/progestin replacement therapy (hormone replacement therapy, or HRT) and alendronate are effective in preventing and treating osteoporosis. However, because these drugs work in somewhat different ways, a combination of the two drugs might protect women from osteoporosis better than either drug alone. In this study we will test whether HRT and alendronate given together for 3.5 years to postmenopausal women with low bone mass will have a greater effect on bone than either HRT or alendronate given alone. We will also give every participant in this study calcium and vitamin D supplements.
Inclusion criteria: inclusion criteria:

 Women at least 60 years of age.

 Good general health.

 Willingness to participate in this 3.5 year study.

 Ability to give informed consent.

 Ability to live independently and travel to the research center for visits (we will provide transportation on a limited basis).

 Spine bone mineral density (BMD) (L1-4) T-score between -1.0 and -2.5, or a hip T-score between -1.0 and -2.5. A T-score of -1.0 is equal to a bone mass of one standard deviation below the mean peak bone mass in healthy young adult women.

Exclusion criteria: :

 Any history of cancer except the following: (a) superficial basal or squamous cell carcinoma of the skin which has been completely resected or resolved by a topical chemotherapeutic agent, and (b) other malignancies treated curatively at least 10 years previously, without any evidence of recurrence.

 Abnormal transvaginal ultrasound that has not been investigated and cleared by endometrial biopsy.

 History of low-trauma hip or spine fracture previously diagnosed.

 Serious residuals from cerebral vascular disease.

 Diabetes mellitus, except for easily controlled, non-insulin dependent or insulin dependent diabetes mellitus without significant microvascular or neuropathic disease.

 Serum creatinine >1.9 mg/dl.

 Chronic liver disease or alcoholism.

 Treatment with bone active agents such as fluoride or bisphosphonates within the previous 2 years.

 Treatment with calcitonin, estrogen, or a selective estrogen receptor modulator within the previous 6 months.

 Systemic corticosteroid therapy at pharmacologic levels for more than 6 months duration.

 Any corticosteroid therapy within the previous 6 months.

 Treatment with anticonvulsant therapy within the previous year.

 Clinically significant abnormalities on pre-study laboratory or clinical screens.

 Treatment with thyroid hormone is accepted, provided the patient is euthyroid at the time of entry, and the serum TSH by ultrasensitive assay is normal.

 Uncontrolled hypertension.

 Unstable angina.

 Myocardial infarction within 1 year prior to entry.

 Evidence of metabolic bone disease, e.g. hyper- or hypoparathyroidism, Paget's disease, osteomalacia, osteogenesis imperfecta, or others.

 Active rheumatoid arthritis or collagen disease.

 Recent major gastrointestinal disease (within the past year) such as peptic ulcer, malabsorption, chronic ulcerative colitis, regional enteritis, or any significant chronic diarrhea state.

 Tobacco use at a level of more than 10 cigarettes per day.


Hypothermia to Treat Severe Brain Injury

Summary: The purpose of this trial is to determine if hypothermia (body cooling), administered very soon after a severe brain injury improves functional outcome. This pilot trial ended in July 2005. Please see clinicaltrials.gov record number NCT00178711 for the Phase III version of the trial (see link below).
Inclusion criteria: ELIGIBILITY CRITERIA FOR EARLY COOLING TO 35°C:

 inclusion criteria:

 GCS 3-8 on initial evaluation or deteriorates during transport

 Mechanism of injury consistent with blunt, non-penetrating trauma to head

 Systolic blood pressure > 110 mm Hg

 Diastolic blood pressure> 60 mm Hg

 Heart rate (pulse) < 120 beats per minute

 Estimated or known age 16-45

 No suspicion of pregnancy

 Esophageal/rectal probe temperature > 35.5°C (Pre-hospital cooling only)

 Injured < 2 hours prior to arrival of pre-hospital providers

 No evidence of severe chest trauma (unilaterally absent breath sounds with tracheal deviation or distended neck veins or requiring thoracentesis).

Exclusion criteria: :

 Following commands upon EMS arrival without deterioration to coma or follows command after an initial period of coma.

 Mechanism of injury GSW or no indication of head injury

 Systolic blood pressure < 120 mm Hg

 Diastolic blood pressure < 60 mm Hg

 Heart rate (pulse) > 120 beats per minute

 Estimated or know age > 45 or < 16

 Suspected pregnancy

 Forehead scan temp < 35.5°C (Pre-hospital cooling only)

 Injured >2 hours prior to arrival of pre-hospital providers

 Evidence of major chest trauma (unilaterally absent breath sounds with tracheal deviation or distended neck veins or requiring thoracentesis.

 ELIGIBILITY CRITERIA FOR 48 HOURS OF MODERATE HYPOTHERMIA (33°C):

 inclusion criteria:

 Non-penetrating brain injury with a post-resuscitation Glasgow Coma Score < 8 (motor 1-5).

['hypothermia (body temperature lowered to 33°C or 91.4°F)']


TRIAD Project: Qualitative Study of Adolescent Depression and Smoking

Summary: It has been shown in the adult literature that smoking is related to depression and visa versa. Not much is known about how this relationship is started or if one perhaps leads to the other. We are performing 1 hour long interviews with adolescents ages 12-19 who meet criteria for major depression and who smoke. They are interviewed along with their parent. Questions center around their view of depression and their history of depression as well as questions around their smoking as well as the interrelationships between the two. Transcripts are made of the interview and are being analyzed for themes.
Inclusion criteria: inclusion criteria:

 12-19 years old

 Major depression

 Smoke cigarettes

 Lives with parents

 No confidentiality issues related to smoking

Exclusion criteria: :

 Non English speaking

 Suicidal ideation

 Pregnant

['Adolescent - Emotional Problem', 'Smoking']


Follow-up Study to Evaluate the Long-term Efficacy of the HPV Vaccine (580299) in Healthy Young Adult Women in Brazil

Summary: Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This Phase IIb study is designed to evaluate the the long-term efficacy, safety and immunogenicity of the 580299 HPV vaccine (CervarixTM) in a Brazilian cohort of women vaccinated in the phase IIb, blinded, primary study 580299/001 (NCT00689741) and having participated in follow-up study 580299/007 (NCT00120848). Only subjects who participated in the primary & follow-up study will be enrolled in this long-term follow-up study. Subjects were aged 15-25 years at the time of entry into the primary study.~The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Inclusion criteria: inclusion criteria:

 Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.

 Subjects who participated in study 580299-007.

 Written informed consent obtained from the subject prior to enrollment.

Exclusion criteria: :

 Use or planned use of any investigational or non-registered product other than the study vaccine.

 Decoding of the subject's 580299-001 treatment allocation to either the subject or the investigator.

 Administration or planned administration of any other HPV vaccine, other than the vaccine administered in study 580299-001.

['Blood sampling', 'Collection of cervical specimen', 'Cervarix']

Blood sampling
Collection of cervical specimen
Cervarix


The GlasVEGAS Study (Glasgow Visceral & Ectopic Fat With Weight Gain in South AsianS)

Summary: South Asians have a much higher risk of diabetes compared to Europeans and investigators don't know why this is. Investigators think that South Asians' capacity to store fat safely under the skin is lower than Europeans, so they start to store fat around internal organs and in liver and muscle, and at lower body weights than Europeans. These increased levels of internal fat storage are thought to increase risk of diabetes.~The purpose of the study therefore is to investigate whether there are differences with weight gain and weight loss in fat storage, fat cell function and metabolic risk factors, in South Asians compared with Europeans. Investigators will compare South Asian and European men at the start of the study, after they have gained about 7% body weight, and again after they have lost 7-15% body weight (from peak weight) to see how gaining and losing weight affects fat storage within the body and the function of fat cells. Investigators will also assess the effect of weight gain and weight loss on metabolism, fitness and risk factors for diabetes and heart disease.
Inclusion criteria: inclusion criteria:

 Participants will be men of European (self-report of both parents of white European origin) or South Asian (self-report of both parents of Indian, Pakistani, Bangladeshi or Sri Lankan origin) with BMI <25 kg.m-2, who have been weight stable (± 2 kg) for >6 months.

Exclusion criteria: :

['Weight Gain', 'Weight Loss', 'Cardiovascular Disease', 'Obesity', 'Diabetes']

Weight Gain
Weight Loss
Cardiovascular Disease
Obesity
Diabetes


Gulf War Digestive Health Study

Summary: The purposes of this study are to estimate the burden of disease due to chronic gastrointestinal illness in PG veterans, to evaluate whether Small Bowel Bacterial Overgrowth (SBBO) is associated with chronic diarrhea in PG veterans, and to determine whether eradication of SBBO reduces symptoms of chronic diarrhea, abdominal pain and bloating in PG veterans.
Inclusion criteria: inclusion criteria:

 Men and women age 32-75 years

 Rome III criteria for diarrhea-predominant IBS

 Symptom onset after an apparent episode of acute gastroenteritis

 Symptoms of > 3 months duration

 Normal endoscopic appearance of the colonic mucosa

 Negative markers for celiac disease and inflammatory bowel disease.

 Normal thyroid function and serum calcium levels.

 Must have served in the military or reserves during the time of Operation Desert Storm (August 1990 to May 1991)

Exclusion criteria: :

 Clinically significant cardiac, pulmonary, hepatic or renal dysfunction

 History of/or presence of systemic malignancy

 Current evidence of any gastrointestinal disorder such as celiac disease or inflammatory bowel disease (i.e. Crohns disease or ulcerative colitis)

 Current effects of drug or alcohol abuse

 Investigator perception of patients inability to comply with study protocol

 Unstable psychiatric disease

 Recent change in gastrointestinal medications

 Subjects with a positive pregnancy test

 Subject is currently participating in another research protocol that could interfere or influence the outcome measures of the present study

['Irritable Bowel Syndrome', 'Small Intestinal Bacterial Overgrowth']

Irritable Bowel Syndrome
Small Intestinal Bacterial Overgrowth


Study to Evaluate Darbepoetin Alfa in Pediatric Subjects With Anemia Due to Chronic Kidney Disease

Summary: The purpose of this study is to find out more about darbepoetin alfa in children less than 1 year of age with anemia (a decrease in red blood cells) due to kidney failure. This study will see if darbepoetin alfa is safe and well tolerated and whether it causes any side effects by taking blood samples and checking vital signs (heart rate, body temperature, and blood pressure tests) at specific times throughout the study. In addition, the study will evaluate the amount of darbepoetin alfa in the blood over time and look at special markers in the blood to evaluate how darbepoetin alfa works on anemia.~Darbepoetin alfa is approved by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) for use in adults, but not for all ages of pediatric subjects. Therefore, studies need to be conducted in pediatric subjects (children) to determine the appropriate dose to use in younger children.
Inclusion criteria: inclusion criteria:

 Girls and boys between birth and < 1 year of age at the time of enrollment

 Body weight ≥ 3 kg at screening and enrollment

 Diagnosis of chronic kidney disease stage 3 to 5 with an estimated Glomerular Filtration Rate < 60 mL/min/1.73m2 without dialysis using the updated Schwartz Equation at screening; OR on dialysis at screening

 Hemoglobin ≤ 9.0 g/dL within 7 days prior to enrollment

 Transferrin saturation ≥ 20% at screening

Exclusion criteria: :

 Premature girls and boys (< 37 weeks of gestation, counting from the first day of the mother's last menstrual period)

 Peritoneal dialysis subjects with an episode of peritonitis within 30 days prior to enrollment

 History of cardiovascular events or thromboembolism

 History of upper or lower gastrointestinal bleeding

 History of seizures

 Active liver disease or history of liver disease

 Uncontrolled hypertension defined as stage 2 hypertension or greater. This is defined as a systolic or diastolic blood pressure value greater than the 99th percentile + 5 mmHg for a subject's age

 Major surgery 12 weeks prior to enrollment

 Red blood cell transfusions 12 weeks prior to enrollment

 Use of any erythropoiesis-stimulating agent within 12 weeks prior to enrollment

 Currently receiving antibiotic therapy for systemic infection within 4 weeks prior to enrollment

 Current or prior use of immunosuppressants (excluding low-dose corticosteroids, defined as ≤ 0.5 mg/kg per day prednisone or equivalent for ≤ 5 days)

 Subject is receiving a dose higher than 0.5 mg/kg per day of prednisone (or equivalent dose of another corticosteroid) for > 5 days within 4 weeks prior to enrollment

 Receiving or has received any investigational drug (or is currently using an investigational device) within the 30 days or 5 half-lives (whichever is longer) prior to enrollment

 Subject has known hypersensitivity to darbepoetin alfa, r-HuEPO, or to any of the excipients


Comparative Study of Autologous Blood Injection Versus Diluted Epinephrine in Treating Actively Bleeding Gastroduodenal Ulcers

Summary: Endoscopic injection of autologous blood can control bleeding from gastroduodenal ulcers.
Inclusion criteria: inclusion criteria:

 all adult patients with gastroduodenal ulcer

Exclusion criteria: :

 Patients with non ulcer bleeding.

 Patients with malignancy.

 Patients with bleeding disorders or under coagulation therapy.

 Patients with known allergy to epinephrine.

['Blood, Injection, Injury Type Phobia', 'Gastrointestinal Ulcer Haemorrhage', 'Adverse Reaction to Epinephrine']

Blood
Injection
Injury Type Phobia
Gastrointestinal Ulcer Haemorrhage
Adverse Reaction to Epinephrine


Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma

Summary: Patients who present to our institution with a traumatic injury to their elbow who need operative management will be randomized to one of two groups; a treatment arm and a control arm. The treatment arm will receive a three-week postoperative course of indomethacin while the control group will not. We will follow both groups to assess whether or not indomethacin prophylaxis affects the rate of heterotopic ossification.
Inclusion criteria: inclusion criteria:

 Terrible Triad

 Radial head fracture surgical treatment

 Monteggia and Trans-olecranon Fracture Dislocations

 Distal Biceps Tendon Injuries

 Distal Humerus Fractures

 Coronoid Fractures

 Capitellar-Trochlear fractures

 Olecranon Fractures

Exclusion criteria: :

 Associated Traumatic Brain Injury

 Burn Injuries associated with elbow trauma

 History of Gastric Ulcers

 Documented allergies to any Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

 Severe Asthma

 Previous operative fixation to affected elbow

 Participation in other research study

 Inability to speak / understand English

['Indomethacin and Pantoprazole', 'microcrystalline cellulose powder tablets']

['Elbow Trauma Requiring Operative Management']


Bioequivalence Study of Torrent Pharmaceuticals Ltd's Felodipine Extended-Release Tablets Under Fasting Condition

Summary: Objective:~Primary objective of the present study was to compare the single dose bioavailability of Torrent's Felodipine Extended-Release Tablets USP 10 mg and Innovator's (Mylan Pharmaceuticals Inc., USA) Felodipine Extended-Release Tablets USP 10 mg. Dosing periods were separated by a washout period of 17 days during fasting study.~Study Design:~Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study
Inclusion criteria: inclusion criteria:

 Healthy males within the age range of 18 to 50 years.

 A body mass index within 18-25 Kg/m2.

 Given written informed consent to participate in the study.

 Absence of diseases markers of HIV 1 & 2, Hepatitis B & C virus and RPR.

 Absence of significant disease or clinically significant abnormal laboratory

 values on laboratory evaluation, medical history and physical examination during the screening.

 A normal 12-lead ECG.

 A normal chest X-Ray.

 Comprehension of the nature and purpose of the study and compliance with the requirements of the entire protocol.

 No history or no evidence of hypersensitivity or idiosyncratic reactions to other nitrates or nitrites.

 No history of allergic rash.

 No history of significant systemic diseases.

 No history of psychiatric disorders or addiction to any recreational drug or drug dependence.

 No donation of blood within 56 days prior to study check-in.

 No participation in any clinical study within the past 56 days.

 No receipt of any prescription drugs or OTC products, with in two weeks prior to study check-in.

 No history of dehydration from diarrhea, vomiting or any other reason within a period of 24 hours prior to study check-in.

 No family history of neurological disorders.

 Not consumed alcohol and xanthine containing food and beverages, cigarettes and tobacco products, for at-list 48 hours, prior to study check-in.

 Negative results for drugs of abuse in urine and alcohol breath analysis during check-in of each period.

 Not consumed grape fruit juice within the 48 hours prior to study check-in.

Exclusion criteria: :

 Blood pressure Systolic> 140 mm Hg and < 110 mm Hg Diastolic< 70 mm Hg > 90 mm Hg

 History of seizures

 History of alcohol consumption for more than 2 units/day.

 High caffeine or tobacco consumption

 History of difficulty with donating blood or difficulty in accessibility of veins.

 Any unusual or abnormal diet, for whatever reason e.g. fasting due to religious reasons.

 Used any pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study


Arterial Elasticity: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)

Summary: The purpose of this study is to find out if starting anti-retroviral therapy (ART) above 500 cluster-of-differentiation-4 (CD4)+ cells/milliliter (mL) ('early ART group') is better at reducing the stiffness of arteries than waiting to start ART until the CD4+ drops below 350 cells/mL ('deferred ART group'). Artery stiffness has been associated with an increased risk of cardiovascular (heart) disease, and could be useful as an earlier indicator of heart disease. In this study, the stiffness of arteries will be measured at study entry, months 4, 8, 12, and annually thereafter, using a tonometer on the participant's forearm.
Inclusion criteria: inclusion criteria:

 Simultaneous co-enrollment in the START study

 Signed informed consent

Exclusion criteria: :

 Inability to ascertain waveform measurements that can be analyzed, i.e. atrial fibrillation


Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study

Summary: Primary Objective:~To determine the effects of a diabetes specific enteral formula compared to a standard formula supplemented with protein (isocaloric and isonitrogenous) on the mean blood glucose and glycemic variability in a homogenous group of critically ill patients in a neurological ICU. Blood glucose will be recorded every minute using a continuous blood glucose monitor. The primary end points will be the difference between the mean blood glucose levels and the glucose variability between the control and intervention groups for the time period that the patient is in the ICU and receiving tube feeds and for up to a maximum of 14 days.~Secondary Objectives:~To determine the effects of the diabetes specific versus standard tube feeds on the change in muscle thickness and volume measured by 2-dimensional ultrasound imaging during the patients ICU stay.
Inclusion criteria: inclusion criteria:

 Patients aged between 18 and 89 years old

 Patients with critical illness including ischemic or hemorrhagic stroke, epidural/subdural bleeds and subarachnoid hemorrhage

 Patients who are expected to stay in the ICU for at least 5 days

 Hyperglycemia is not an inclusion criteria

Exclusion criteria: :

 Patients who have received or will be treated with systemic corticosteroids.

 Patients who will be receiving high doses of propofol (>40 cc/hr)

 Patients with type 1 Diabetes

 Patients with sepsis or acute trauma

 Patients with an expected stay in the ICU of less than 4 days

 Patients who are unable to receive enteral nutrition or who have medical conditions precluding nutrition by the enteral route including allergies to formula components

 Pregnant and lactating patients

 Patients with prior history of gastroparesis

 Patients with acute kidney failure (creatinine > 2.5mg/dl)

 Patients with acute liver failure (bilirubin > 2.0 mg/dl)

['Subarachnoid Hemorrhage', 'Intracranial Hemorrhage', 'Ischemic Strokes', 'Subdural Hematoma']

Subarachnoid Hemorrhage
Intracranial Hemorrhage
Ischemic Strokes
Subdural Hematoma


A Pilot Study of PET-CT in the Assessment of Pulmonary Nodules in Children With Malignant Solid Tumors

Summary: Because the management of children with solid tumors hinges on the extent of disease, it is crucial to identify metastatic sites. Helical chest computed tomography (CT) is the standard method of excluding pulmonary metastases. However, CT lacks molecular information regarding nodule histology and often biopsy is required to exclude malignancy. Biopsy procedures carry known risks including those associated with anesthesia and sedation, infection, pneumothorax, hemorrhage, pain and other post-procedure and post-operative complications and may also add unnecessary cost to the management of the patient. We found that the ability of three experienced pediatric radiologists to correctly predict nodule histology based on CT imaging features was limited (57% to 67% rate of correct classification). Also, there was only slight to moderate agreement in nodule classification between these reviewers.~Furthermore, of 50 children who have undergone pulmonary nodule biopsy at St. Jude in the last five years, 44% (22/50) had only benign nodules.~Adult studies have shown that a nuclear medicine scan called fluoro-deoxyglucose (FDG) positron emission tomography (PET) and the fusion modality PET-CT are superior to diagnostic CT in distinguishing benign from malignant pulmonary nodules because FDG PET gives information about the metabolic activity of the nodule. Nodules that are malignant have more metabolic activity, hence more FDG uptake/intensity, than those that are benign. There has been little work done in children to determine the value of PET or PET-CT in the evaluation of pulmonary nodules.
Inclusion criteria: inclusion criteria:

 Participant has a known or clinically suspected solid malignancy (excluding brain tumor)

 Nodule must be discovered at the time of diagnosis of the primary malignancy or after the completion of therapy

Exclusion criteria: :

 Participant has not been off therapy for at least 3 weeks before undergoing PET-CT


The Effects of Thalidomide on Symptom Clusters

Summary: The goal of this clinical research study is to learn if thalidomide can improve symptoms such as pain, fatigue,anxiety, poor appetite, depression, and sleep problems in patients with advanced cancer.
Inclusion criteria: inclusion criteria:

 Have weight loss of > 5% within the last 6 months

 Present with anorexia, fatigue and one of the following: anxiety, depression or sleep disturbances, during the preceding 24 hours, with an average intensity of each symptom >/= 3 on a scale of 0 to 10, in which 0=no symptom, and 10= the worst possible symptom.

 Describe the symptoms as being present every day for a minimum of 2 weeks.

 Have no clinical evidence of cognitive failure

 Must be 18 years or older.

 Expect to live at least >/= 4 weeks

 Must have negative serum pregnancy test within 24 hours of study enrollment in women of childbearing potential. FDA criteria for the status of not of childbearing potential, hysterectomy, or menopausal for 24 consecutive months.

 Understand and sign written informed consent.

 Have no concurrent steroids with the exception of steroids used concurrently with chemotherapy as part of a regimen or to reduce nausea.

 Willing and able to comply with S.T.E.P.S.[System for Thalidomide Education and Prescribing Safety]

 Patient's Absolute neutrophil count (ANC) at time of study enrollment is >/= 750 mm (to be drawn within 14 days prior to registration)

 May be on chemotherapy if at a stable dose. Targeted therapies or hormone therapies are permitted once patient has completed two weeks of treatment.

Exclusion criteria: :

 Have major contraindication to thalidomide, i.e. hypersensitivity.

 Present with National Cancer Institute (NCI) Common Toxicity Criteria Grade 3 or more peripheral neuropathy.

 Are not able to complete the baseline assessment forms.

 Are pregnant or lactating.

 Patients with clinical history of seizures

 Patients with an ANC of </= 750 at time of study enrollment will be excluded (to be drawn within 14 days prior to registration).

 Patients with a history of Acquired Immune Deficiency Syndrome (AIDS), systemic lupus erythematous, or renal failure as defined by a serum creatinine of > 2.0 mg/dl at baseline will be excluded (to be drawn within 29 days prior to registration).

 Patients on Revlimid (lenalidomide).

 Patients on investigational chemotherapy/agents.


Study of Alternative Vaccination Schedule of Oral Cholera Vaccine

Summary: The absence of a boosting response after a 14 day interval with the two-dose regimen of the modified killed oral cholera vaccine raises the possibility that a longer dosing interval may be required to observe a boost in the immune response. This study will compare the immune responses following 14-day and 28-day dosing intervals.
Inclusion criteria: Healthy, non-pregnant adults aged 18 years and above and healthy children aged 1 - 17 will be recruited in Kolkata.

 inclusion criteria:

 Males or non-pregnant females aged 18 years and above and children aged 1 -17 years who the investigator believes will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection).

 Written informed consent obtained from the subjects or their parents/guardians, and written assent for children aged 12 - 17 years.

 Healthy subjects as determined by:

 Medical history

 Physical examination

 Clinical judgment of the investigator

Exclusion criteria: :

 Ongoing serious chronic disease

 For females of reproductive age: Pregnancy (or females planning to become pregnant during the study period; as determined by verbal screening)

 Immunocompromising condition or therapy (for corticosteroids this would mean ≥0.5 mg/kg/day)

 Diarrhea (3 or more loose/watery stools within a 24-hour period) 6 weeks prior to enrollment

 One or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months

 One or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months

 Intake of any anti-diarrhea medicine in the past week

 Abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours

 Acute disease one week prior to enrollment, with or without fever. Temperature ≥38ºC warrants deferral of the vaccination pending recovery of the subject

 Receipt of immunoglobulin or any blood product during the past 3 months

 Receipt of antibiotics in past 14 days

 Receipt of live or killed enteric vaccine in past 4 weeks

 Receipt of killed oral cholera vaccine

['Modified killed oral cholera vaccine at 14 day interval', 'Modified killed oral cholera vaccine at 28 day interval']

['Cholera', 'Diarrhoea', 'Vibrio Infection']


Focal Cortical Atrophy After Myocardial Internal Capsule

Summary: Primary purpose of the trial is to demonstrate the arisen of focal cortical atrophy, localized in the ipsilateral primary motor area, measured in mm, three months after infarction of internal capsule.~The patient is compared to himself between day zero to ten and three months.~The study hypotheses are:~A focal cortical atrophy of the ipsilesional primary motor area occurs after cerebral infarction of the internal capsule. It is measurable accurately and reproducibly by MRI at three months. Other brain areas within the voluntary motor system will also be explored (supplementary motor area, pre motor area).~This atrophy is correlated with achievement of pyramidal tract, assessed by the fractional anisotropy of its fibers.~This atrophy is correlated with disability at three months, assessed by Rankin score.
Inclusion criteria: inclusion criteria:

 Patients of 18 to 90 years old.

 Subcortical stroke

 Achievement of the internal capsule, according to MRI

 Ability to perform MRI within 10 days after the onset of symptoms

 NIHSS over or equal 2 and < 20

 Rankin Score over or equal 1 and ≤ 5

 Written informed consent after information about the protocol, from patients or reliable person if patient is in incapacity to sign

 Affiliation to a social security scheme

Exclusion criteria: :

 Pregnant or nursing women

 Other cerebral lesion, concomitant or preexisting

 Concomitant disease causing unfavorable prognosis within 3 months after inclusion

 pre-existing psychiatric illness

 Alcoholism or other chronic intoxication

 Cortical localization of the infarction

 Patient in a coma, who cannot be examined and evaluated

 Patient intubated, ventilated, sedated

 Cerebral hemorrhage, intra-parenchymal and / or subarachnoid

 Persons protected by law (guardianship, curators and judicial protection)

 Contraindications to magnetic resonance examination: pacemaker, metal implants, neurostimulators, Clips neurosurgical wire sutures, staples, metal heart valves, ventricular bypass valve, metal workers, foreign eye, shrapnel, bullet , cochlear implants


Aspirin Resistance in Systemic Lupus Erythematosus (SLE)

Summary: This study examine whether patients with lupus respond to aspirin , and if not, if that is related to inflammation. We examine the ability of aspirin to inhibit the production of thromboxane in patients with lupus and controls and see if aspirin insensitive thromboxane production is inhibited by meloxicam.
Inclusion criteria: inclusion criteria:

 Written Informed consent.

 Age >18 yrs.

 SLE meeting ACR criteria {Tan, Cohen, et al. 1982 1482 /id} for at least 6 months.(SLE group)

 Stable disease activity as evidenced by no change in immunosuppressive therapy in the past 1 month.

 If female of childbearing potential must use an effective method of birth control

Exclusion criteria: .

 Renal disease (creatinine >1.5 mg/dL, dialysis, 2+ or more proteinuria)

 Previous or current history of peptic ulcer disease or gastrointestinal bleed.

 Previous or current thromboembolic or ischemic cardiovascular event (stroke, myocardial infarction, angina) - can do aspirin part of study.

 Currently taking an anticoagulant or antiplatelet agent (besides aspirin).

 Thrombocytopenia (platelet count <135,000)

 Pregnancy

 Allergy to aspirin, NSAIDs

 NSAIDs in the previous week


Spectral Diagnosis of Cutaneous Malignancy

Summary: The goal of this clinical research study is to evaluate the use of an imaging technology called spectral diagnosis. Researchers want to find out if a special spectral-diagnosis probe can be used to detect skin cancers.
Inclusion criteria: inclusion criteria:

 Male or Female and over 18 years of age.

 Patients undergoing an examination of their skin

 Patients with a lesion(s) in one of the five categories: basal cell carcinoma, squamous cell carcinoma, pre-cancer lesions, pigmented lesions, and benign lesions

 Patients whose lesion also warrants a biopsy.

 Signed informed consent document.

Exclusion criteria: :

 Patients with absence of skin lesion(s) in one of the five categories.

 Patients whose identified lesion did not need a biopsy.

 Patients who did not sign the informed consent and agree to participate.


Safety and Immunogenicity of a Single Dose of Intranasal Seasonal Trivalent Live-Attenuated Influenza Vaccine

Summary: In this Phase II randomized controlled clinical trial, generally healthy male and female children from 24 through 59 months of age will be enrolled in Kamalapur (Dhaka), Bangladesh. The study is expected to continue for at least 6 months following vaccination. The experimental intervention is Serum Institute of India Ltd's Trivalent, Seasonal Live Attenuated Influenza Vaccine (SIIL LAIV). The study vaccine has been formulated according to WHO recommendations for the 2011-2012 Northern Hemisphere influenza season. The SIIL LAIV is administered in a 0.5 ml intranasal dose (one spray of 0.25 ml per nostril) via a reusable sprayer device and a single-use nozzle that produces a fine mist that is primarily deposited in the nose and nasopharynx. The comparator vaccine will be an inactive placebo identical in appearance to the active vaccine.~The primary study hypothesis is that LAIV is safe and well tolerated by children aged 24 through 59 months in Bangladesh. A secondary hypothesis is that LAIV is immunogenic among children receiving study vaccine as compared to children receiving placebo.
Inclusion criteria: inclusion criteria:

 Healthy male or female child at least 24 months of age and no older than 59 months of age at the time of study vaccination

 A child whose parent or guardian's primary residence, at the time of study vaccinations, is within the Kamalapur surveillance site catchment area and who intends to be present in the area for the duration of the trial

 A child whose parent or legal guardian is willing to provide written informed consent prior to the participant's study vaccination

Exclusion criteria: :

 Has any serious chronic disease including progressive neurologic disease, tuberculosis, Down's syndrome or other cytogenetic disorder, or known or suspected disease of the immune system

 Is receiving immunosuppressive agents including systemic corticosteroids during the two weeks prior to study vaccination

 Has a history of documented hypersensitivity to eggs or other components of the vaccine (including gelatin, sorbitol, lactalbumin and chicken protein), or with life-threatening reactions to previous influenza vaccinations

 Is receiving aspirin therapy or aspirin-containing therapy currently or two weeks before

 Lives in household with somebody currently participating in a respiratory vaccination or antiviral study

 Has current or past participation (within 2 months of trial enrollment visit) in any clinical trial involving a drug or biologic with activity against respiratory disease

 Has any condition determined by investigator as likely to interfere with evaluation of the vaccine or be a significant potential health risk to the child

['SIIL LAIV (live, trivalent seasonal influenza vaccine)', 'Placebo']

SIIL LAIV (live
trivalent seasonal influenza vaccine)
Placebo


APC-111 MP Tablet Once a Day vs.Penicillin VK Four Times a Day Both for 10 Days in Patients With Strep Throat

Summary: The primary objective of this study is to evaluate the efficacy of APC 111 MP Tablet, 775 mg tablet, given orally (PO)once daily (QD) for 10 days compared to that of Penicillin VK, 250 mg PO four times daily (QID) for 10 days in terms of bacteriological outcome at the Test-of-Cure (TOC) Visit (Day 14-18) in the eligible Per-Protocol bacteriological (PPb) population.
Inclusion criteria: inclusion criteria:

 Informed consent/assent

 Age 12 and older

 A clinical diagnosis of acute tonsillitis and/or pharyngitis defined as having the clinical signs and symptoms compatible with tonsillitis and/or pharyngitis, including sore throat and pharyngeal erythema with at least one of the following:

 Odynophagia

 Tonsillar or pharyngeal exudates

 Tender cervical lymph nodes

 Fever or history of fever treated with antipyretics

 Chills

 Uvular edema

 Elevated white blood cell count

 Red tongue and prominent papillae

 A positive rapid screening test for S. pyogenes

 Subject is an appropriate candidate for oral antibiotic therapy and can swallow the study dosage forms

 Females must be non-lactating and:

 At no risk of pregnancy for one of the following reasons: post-menopausal for at least one year, hysterectomy, tubal ligation, or abstinent from sexual activity that could result in pregnancy, OR

 If of child-bearing potential and sexually active, the patient must have a negative baseline urine pregnancy test and be utilizing acceptable contraceptives throughout the study.

 If of child bearing potential and not currently sexually active, the patient must have a negative baseline urine pregnancy test and must agree to remain abstinent for the duration of the study. If they decide to become sexually active during the period of the study, they must agree to use acceptable contraception.

 Are able to comply with the requirements of the protocol

Exclusion criteria: :

 Chronic or recurrent odynophagia or enlarged tonsils of obscure etiology

 More than one episode of acute tonsillitis and/or pharyngitis in the 6 months prior to baseline visit

 Pharyngitis known or suspected to be due to a pathogen resistant to β-lactam antimicrobials

 Subjects who are known carriers of S. pyogenes

 Previous allergies, serious adverse reaction to, or intolerance to penicillin or any other member of the β-lactam class of antimicrobials, including cephalosporins

 Any serious illness or concomitant condition that the Investigator judges would preclude the study evaluations or make it unlikely that the course of study therapy and follow-up could be completed. This would also include:

 Any rapidly progressive underlying disease with a shortened life expectancy

 The inability to swallow the study dosage form

 Unable to understand the requirements of the study

 Neutropenia (<1000 PMNs/mm3) or other immunocompromised state.

 Concurrent condition of upper/lower respiratory tract infections

 Concurrent symptoms of viral etiology including:

 conjunctivitis, coryza, and cough

 diffuse adenopathy or rash suggestive of mononucleosis

 rash or arthropathy suggestive of scarlet fever

 Seizure disorder, lowered seizure threshold, or psychiatric condition requiring use of major tranquilizers

 Pregnancy or nursing

 Expectation that additional effective systemic antibacterials would be required for any condition during the duration of the study

 Current drug or alcohol abuse

 Receipt of any experimental drug or medical device within the previous 30 days

 Previous treatment under this protocol

 The need for hospitalization or I.V. antimicrobial therapy

 Previous systemic antimicrobial therapy within 30 days

 The presence of clinically significant hematologic conditions

 History of cardiovascular disease, renal disease, or neurological disease secondary to previous infection with S. pyogenes or previous rheumatic fever

 Probenecid treatment or systemic steroids for 7 days prior to baseline visit and throughout the duration of the study

['Sore Throat', 'Pharyngitis', 'Tonsillitis']


Efficacy Comparison Study of Combination Regimens to Treat Advanced Esophageal Squamous Cell Carcinoma

Summary: Until today, the 5-FU/cisplatin combination is the reference regimen with 30-45% response rates, which is most commonly used to treat patients with metastatic, recurrent or locally advanced, unresectable squamous cell carcinoma of the esophagus. Because the classical dose schedule of this two-drug combination is cisplatin 100 mg/m2 day 1 and 5-FU 1000 mg/m2/day continuous infusion for 96-120 hr, prolonged administration time and mucosal toxicity are inconvenient to the patients with the aim of palliation. Capecitabine, which is oral prodrug of 5-FU and mimic continuously-infused 5-FU, is being investigated in phase I, II and III trials for the treatment of gastric, gastroesophageal, and esophageal cancers, primarily in the first-line metastatic setting. In our experience, capecitabine plus cisplatin combination (XP) as a first-line treatment for 45 patients with advanced or recurrent esophageal squamous cell carcinoma demonstrated a promising anti-tumor activity with 57% of response rate and showed tolerable toxicity with convenience.~Paclitaxel has been also investigated as monotherapy and in combination with cisplatin in patients with advanced esophageal cancer. A Dutch phase II study demonstrated that paclitaxel combination with carboplatin had shown an encouraging confirmed response rate of 59% with 51 patients with resectable esophageal cancer in neoadjuvant setting. Another Dutch phase II study showed 43% of response rate including 4% of CR with 8 months of response duration when paclitaxel plus cisplatin administration was given for patients with metastatic esophageal cancer. Although recently first-line palliative chemotherapy regimen in esophageal cancer has been investigated, many trials have failed to show superiority to 5-FU/cisplatin combination. Since we considered that XP or XT is more effective and convenient chemotherapy regimen than 5-FU/cisplatin, this randomized phase II study was planned to compare XP with XT in terms of efficacy and tolerability.
Inclusion criteria: inclusion criteria:

 Histologically confirmed metastatic, or recurrent esophageal squamous cell carcinoma

 Age > 18 years

 ECOG performance status 0 - 2

 At least one measurable lesion(s) by RECIST criteria

 Life expectancy ≥ 3 months

 Patients may have received prior adjuvant chemotherapy with 5-FU with cisplatin as long as it has been 12 months since completion of regimen.

 No previous palliative chemotherapy

 Prior radiotherapy must be completed 4 weeks before study entry.

 Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)

 Adequate renal function (≤ serum creatinine 1.5 mg/dl or CCr ≥ 50 ml/min)

 Adequate liver function (≤ serum bilirubin 1.5 mg/dl, ≤ AST/ALT x 3 upper normal limit)

 Written informed consent

Exclusion criteria: :

 Other tumor types such as adenocarcinoma, small cell carcinoma

 Evidence of CNS metastasis

 Contraindication to any drug contained in the chemotherapy regimen

 Previous adjuvant treatment with 5-FU, cisplatin, capecitabine or paclitaxel finished less than 1 year

 Evidence of serious gastrointestinal bleeding

 History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix

 Clinically significant cardiac disease (e.g. severe non-compensated hypertension, non-compensated heart failure, dilated cardiomyopathy, and coronary heart disease with ST segment depression in ECG) or myocardial infarction within the last 6 months.

 Serious pulmonary conditions/illness (e.g. chronic lung disease with hypoxemia)

 Serious metabolic disease such as severe non-compensated diabetes mellitus

 History of significant neurologic or psychiatric disorders

 Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease

 Positive serology for the HIV

 Pregnant or lactating women

['Capecitabine plus cisplatin(XP) versus capecitabine plus paclitaxel(XT)']

['First Line Chemotherapy', 'Capecitabine Plus Cisplatin Versus Capecitabine Plus Paclitaxel', 'Advanced or Recurrent Esophageal Squamous Cell Carcinoma']


Effects of Black Cohosh on Menopausal Hot Flashes

Summary: This study will assess whether treatment with black cohosh is effective in reducing the frequency and intensity of menopausal hot flashes. In addition, this study will determine whether or not black cohosh reduces the frequency of other menopausal symptoms and improves quality of life.
Inclusion criteria: inclusion criteria:

 Resident of the New York Metro Area

 Postmenopausal

 Weight within 90% to 120% of ideal body weight
Exclusion criteria:

['Postmenopause', 'Hot Flashes', 'Osteoporosis, Postmenopausal']

Postmenopause
Hot Flashes
Osteoporosis
Postmenopausal


A Study to Assess the Effect of Tocilizumab + Methotrexate on Prevention of Structural Joint Damage in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)

Summary: This 3 arm study will compare the safety and efficacy, with respect to a reduction in signs and symptoms and prevention of joint damage, of tocilizumab versus placebo, both in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients will be randomized to receive tocilizumab 4 mg/kg IV, tocilizumab 8 mg/kg IV or placebo IV, every 4 weeks. All patients will also receive methotrexate, 10-25 mg/week. The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals. After completion of the 2 year study participants could participate in the optional 3 year open label extension phase (year 3 to 5).
Inclusion criteria: inclusion criteria:

 adult patients at least 18 years of age with moderate to severe active RA for at least 6 months;

 inadequate response to a stable dose of MTX;

 patients of reproductive potential must be using reliable methods of contraception.

Exclusion criteria: :

 major surgery (including joint surgery) within 8 weeks before entering study, or planned surgery within 6 months after entering study;

 prior treatment failure with an anti-tumor necrosis factor agent;

 women who are pregnant or breast-feeding.

['tocilizumab [RoActemra/Actemra]', 'Placebo', 'Methotrexate']

tocilizumab [RoActemra/Actemra]
Placebo
Methotrexate


Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 6 to 16 Years.

Summary: The purpose of this study is to investigate the safety and immunogenicity of three different concentrations of a TBE vaccine will be investigated in healthy children aged 6 to 16 years.
Inclusion criteria: inclusion criteria:

 Male and female children will be eligible for participation in this study if:

 they are 6 years (from the 6th birthday) to 16 years old (to the last day before the 16th birthday);

 they are clinically healthy;

 their legal representative - and if older than 8 years the volunteer - understands the nature of the study, agrees to its provisions and gives written informed consent;

 their legal representative agrees to keep a Volunteer Diary.

 For safety reasons female volunteers capable of bearing children have to fulfill the following inclusion criteria at study start:

 negative pregnancy test at study start;

 they agree to employ adequate birth control measures for the duration of the study.

Exclusion criteria: :

 Children will be excluded from participation in this study if they:

 have a history of any previous TBE vaccination;

 have a history of TBE infection or show evidence of a latent TBE infection (as demonstrated by screening ELISA > 126 VIEU/ml and / or neutralization test > 1:10);

 have a history of allergic reactions, in particular to one of the components of the vaccine;

 have received antipyretics within 4 hours prior to the first TBE vaccination;

 suffer from a disease that cannot be effectively treated or stabilized;

 suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment that can be expected to influence immunological functions;

 suffer from chronic, degenerative and / or inflammatory disease of the central nervous system;

 are known to be HIV positive (a special HIV test is not required for the purpose of the study);

 suffer from a febrile illness at study entry;

 have a history of vaccination against yellow fever and / or Japanese B-encephalitis;

 are participating simultaneously in another clinical trial.

 if female, are pregnant or breast feeding

 Volunteers who meet the inclusion /