Long Term Immunogenicity of Quadrivalent Human Papillomavirus Vaccine (Gardasil®)in HIV-infected Adolescents and Young Adults

Summary: Infection with human immunodeficiency virus (HIV) is an important risk factor for HPV infection and the development of HPV-associated lesions in female and male anogenital tract. Data on safety and immunogenicity of quadrivalent human papillomavirus vaccine in HIV-infected population are few. The present study is a non-randomized controlled clinical trial with the primary objective to determine safety ad immunogenicity of quadrivalent human papillomavirus vaccine (Gardasil®) in HIV-infected female and male adolescents and young adults.
Inclusion criteria: inclusion criteria:

 For both HIV-infected and healthy subjects:

 Subjects aged 13-27 years, females and males

 Written informed consent from parent or guardian if applicable (age<18 years)

 For HIV-infected subjects:

 HIV-positive

 Asymptomatic subjects (generalized lymphadenopathy is accepted)

 Lymphocyte CD4+ count > or equal to 350 cells/mm3

 For subjects receiving HAART:

 Good compliance to therapy

 At least two suppressed viral loads HIV-RNA (<37copies/ml9 during 6 months prior to enrollment.

Exclusion criteria: :

 For female subjects (both HIV-infected and healthy)

 Pregnancy or breastfeeding

 Total hysterectomy. Participants who have undergone partial hysterectomy and have a cervix are not excluded.

 For both females and males (HIV-infected and healthy):

 Prior vaccination with quadrivalent HPV vaccine Gardasil before study entry.

 History of severe allergic reaction after previous vaccination or hypersensitivity to any vaccine component.

 Any serious chronic or progressive disease (other than HIV) according to the judgment of the investigator:

 Acute infection requiring therapy or fever at time of enrollment

 Chronic autoimmune or oncologic disease receiving chemotherapy

 Concomitant therapies (other than HAART):

 Chronic therapy (for more than 14 days consecutively) with immunosuppressive or immunomodulating agents or chemotherapy during the 6 months prior to study entry.

 Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation prior to study entry.

 Use of investigational agents within 4 weeks prior to study enrollment.

 Current drug or alcohol use or dependence.

 Documented history of non-adherence to antiretroviral treatment regimen within 12 months prior to study entry.

['Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®)', 'Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®)']

Quadrivalent Human Papillomavirus (6
11
16 and 18) vaccine (Gardasil ®)
Quadrivalent Human Papillomavirus (6
11
16 and 18) vaccine (Gardasil ®)


NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Summary: Background:~- Asthma is a serious clinical and public health problem. Researchers want to collect data to better understand how bacteria and other things in the environment can affect people's asthma.~Eligibility:~- Nonsmoking adults age 18 - 60 who have moderate to severe asthma and are not pregnant or breastfeeding.~Design:~Partaicipants will complete a medical history form before the first visit.~Study visits will include collecting medical history, and conducting physical exam, lung and smoking tests. Participants will give blood, urine, stool, dust, saliva, and sputum samples.~Participants will take tests that measure their breathing abilities. They will give saliva samples for DNA study. They will get kits to collect stool and dust samples at home. They will fill out surveys.~Participants will have visits every 6 months for 5 years. They can schedule sick visits, if needed, at no cost to the participant. For all visits, they will have asthma check-ups and get treatment, at no cost to the participant.~Some participants may take part in a sub-study that includes one 4-hour visit. They will have medical history, physical exam, and lung tests. They will have urine tests to check for pregnancy and tobacco exposure. Then they will have bronchoscopy. For this, an intravenous line will be placed in an arm vein. The nose and throat will be numbed. A flexible fiber-optic tube will be inserted into their airways through the nose. Their airways will be examined and areas of their lung will be washed. A small sample of cells will be taken.
Inclusion criteria: inclusion criteria

 Participants must meet all of the following criteria for enrollment:

 Male or female, 18 to 60 years of age

 Must have clinical evidence of moderate-severe atopic asthma:

 self-reported symptoms suggestive of asthma (such as wheezing, chest tightness, shortness of breath, cough nocturnal symptoms)

 within the past year, and

 --*a positive methacholine test confirming diagnosis [provocative concentration causing a 20% fall in forced expiratory volume in 1 second (PC20 FEV1) <16 mg/mL for participants on inhaled corticosteroids and <8 mg/mL for participants not on inhaled corticosteroids] or postbronchodilator FEV1 with at least 12% or 200 mL increase in FEV1 or forced volume vital capacity (FVC) on bronchodilator challenge, and

 --no other diagnosis that could explain symptoms.

 If there is documentation of a recent methacholine challenge, those results may be used in lieu of conducting a secondary methacholine challenge.

 Permanently resides within 50 miles of the CRU.

 Able to present a valid government issued form of identification for entry to the NIEHS campus

 Able to receive asthma treatment medication(s) via mail

 Willingness to comply with instructions regarding medication regimen, diet, and life style as directed by the investigator that are required per protocol

 Access to a vacuum cleaner with a detachable hose component

 If a woman is found to be pregnant or breastfeeding at the screening or baseline visit, they may continue their participation in the study but will be excluded from participation in the methacholine challenge and bronchoscopy procedures in this study while pregnant.

 Bronchoscopy Visit Inclusion Criterion

 In addition to the above inclusion criteria, participants must be able to fast for 6 hours (no food or drink, except a small amount of water if needed to take approved medications) prior to the bronchoscopy visit in order to be eligible for enrollment in the bronchoscopy visit.

Exclusion criteria:

 Participants meeting any of the following criteria at screening will not be eligible for enrollment or to continue with study visits:

 Current smoker, significant second-hand smoke exposure (defined by urine cotinine >200 ng/mL at screening), or a history of smoking greater than 5 pack years. Smoking encompasses all inhaled products, including e-cigarettes.

 piCO Smokealyzer value of >11ppm

 History of the following comorbidities: chronic obstructive pulmonary disease, cystic fibrosis (CF), emphysema, non-CF bronchiectasis, pulmonary fibrosis, sarcoidosis, unstable angina, pulmonary hypertension

 Allergy or history of adverse reactions to methacholine

 Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with required study procedures

 Comorbid diseases that affect global health or survival- such as DVT, pulmonary embolism, class III - IV congestive heart failure, or a malignancy under treatment

 Bronchoscopy Visit


Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry

Summary: The purpose of this prospective, observational cohort study is to evaluate the incidence of adverse events of special interest (AESI) and effectiveness in participants with active, autoantibody-positive SLE treated with and without BENLYSTA (belimumab). Participants will be enrolled into 1 of 2 cohorts: (1) BENLYSTA cohort: participants receiving or initiating BENLYSTA plus standard of care (SOC) at Baseline; (2) comparison cohort: participants not receiving BENLYSTA but receiving SOC at Baseline. After enrollment, changes in lupus medications, including starting or stopping BENLYSTA, are at the discretion of the physician, and all participants will continue to be followed regardless of changes in their lupus medicines until study completion. All participants will be assessed for AESI including serious infections, opportunistic infections and other infections of interest, malignancies, selected serious psychiatric events and mortality. Data will be collected at enrollment and at 6 month intervals for 5 years. BENLYSTA is a registered trademark of GlaxoSmithKline (GSK) group of companies.
Inclusion criteria: inclusion criteria:

 Males or females age 18 years or older.

 Have a clinical diagnosis of active SLE.

 Current or history of autoantibody-positive SLE.

 Must be treated with SLE therapy including BENLYSTA and/or immunosuppressants (for example, azathioprine, methotrexate, cyclophosphamide, mycophenolate, and biologics).

 Have the ability to understand the requirements of the study, provide written informed consent, including consent for the use and disclosure of research-related health information, and comply with the study data collection procedures.

Exclusion criteria: :

 Treatment with an investigational drug within one year of enrollment. Investigational drug applies to any drug not approved for sale in the country it is being used.

 Currently enrolled in a placebo-controlled BENLYSTA (belimumab) clinical trial or a continuation protocol where belimumab is used as an investigational agent.

 Participants who have a history of BENLYSTA exposure, but are not currently receiving BENLYSTA.

 Participants only receiving an anti-malarial for SLE.

 Participants only receiving steroids for SLE.


Correlation Between Circulating Galactomannan and Beta-D-glucan and Clinical Outcome of Invasive Aspergillosis

Summary: The investigators hypothesize that early galactomannan and beta-D-glucan features, namely the height of the initial value at the time of diagnosis and the subsequent rate of marker decay within the first week(s) following therapy (day 7, day 14) are important factors in predicting clinical outcome.
Inclusion criteria: inclusion criteria:

 proven or probable invasive aspergillosis with positive GM antigen test

Exclusion criteria: :

 Seronegative aspergillosis


Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation

Summary: Treatments for stable angina includes drug therapy such as calcium-channel blocker, beta blocker, and ACEI/ARB. To obtain good prognosis in patients with coronary artery disease,preventing or correcting the progression of atherosclerosis and dyslipidemia is more important than relieving angina symptom. Dysfunction of microvessel is one of the most important factor in patients with coronary artery disease. Recently, we developed the new non-invasive method of evaluating the microvessel in fundus. With this methods, we will compare the effect of each drug (beta blocker, CCB, ARB).
Inclusion criteria: inclusion criteria:

 Stable angina patients whose coronary lesions is confirmed by angiography or receives PCI

 Unstable Angina/NSTEMI patients who completed PCI for main lesions

 Either systolic > 130mmHg or diastolic > 80mmHg, or patients with anti-hypertensive drugs

Exclusion criteria: :

 STEMI patients within one month

 Variant Angina

 Liver function abnormality or renal failure

 History of Hypersensitivity to testing drugs

 Severe heart failure(NYHA class>3) or uncorrectable hematologic disease

 Woman possible to be pregnant

 Uncontrolled diabetes

 Expected life span < one year

['Diltiazem treated group', 'Bisoprolol treated group', 'Candesartan treated group']

Diltiazem treated group
Bisoprolol treated group
Candesartan treated group


Clinical Investigation for Safety and Efficacy Study of CELT ACD (Arterial ClosureDevice)

Summary: The objective of the CELT ACD® Vascular Closure Device study is to evaluate the safety and effectiveness of the CELT ACD® device to achieve hemostasis of the common femoral artery access site in patients on anticoagulation who are undergoing a percutaneous intervention (PCI) procedure using a 6F sheath.
Inclusion criteria: inclusion criteria:

 Over 18 years of age.

 Each patient, or his or her guardian or legal representative, is willing to give informed consent.

 Clinically indicated for an intra-arterial procedure involving access through the common femoral artery and conducted through an access sheath size of between 6F and 7F inclusive.

Exclusion criteria: :

 Patients with known allergy to any of the materials used in the device.

 Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than one year.

 Evidence of systemic bacterial or cutaneous infection, including groin infection.

 Patients suffering with definitive or potential coagulopathy or platelet count <100,000./µl

 Use of systemic thrombolytic agents within 24 hours prior to or during the catheterization procedure which cause the concentration of fibrinogen to be < 100 mg/dl or if post-thrombolytic fibrinogen (in case of thrombolysis within 24 hours or intra-procedural) cannot be measured.

 Patients in whom an introducer sheath smaller than 6F or greater than 7F have been used.

 Currently participating in another investigational device or drug study.

 Patients with severe claudication, iliac or femoral artery diameter stenosis greater than 50%, or previous bypass surgery or stent placement in the vicinity of the access site.

 If puncture site is via a vascular graft.

 If a palpable haematoma is observed during the procedure.

 Patients in whom there is any indication that puncture has been made in the profunda femorals artery or superficial femoral artery, or adjacent to the bifurcation.

 Patients with a common femoral artery lumen diameter of less than 5 mm.

 Patients that have any amputation from an access site limb.

 Patients that have undergone a percutaneous procedure using a vascular closure device for hemostasis within the previous 30 days or using manual/mechanical pressure for hemostasis within the prior 30 days in the same leg.

 Patients with a systolic blood pressure reading below 90 mmHg.

 Patients with an active haematoma, arteriovenous fistula, or pseudoaneurysm.

 Patients with a very superficial artery where the depth from skin to the artery surface at the access site is less than 4 mm.

 Morbidly obese patients (Body Mass Index >35kg/m2).

 Patients with a stent less than or equal to 1 cm of the puncture site that would interfere with placement of the device implant.

 Patient is know or suspected to be pregnant, or is lactating.

 Patients in whom there has been an antegrade puncture.

 Patients in whom there has been difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial wall puncture.

 Patients who have undergone prior or recent use of an intra-aortic balloon pump through the arterial access site.

 Patients with uncontrolled hypertension (BP greater than or equal to 180/110mmHg) at time of vascular closure

 Patients with acute ST-elevation myocardial infarction less than or equal to 48hours before catheterization procedure.

 Patients with cardiogenic shock (hemodynamic instability requiring intravenous medication or mechanical support) experienced during or immediately post-catheterization.

 Patients who are unable to ambulate at baseline.

 Patients known to require an extended hospitalization (e.g. patient is undergoing cardiac surgery).

 Patient has already participated in the trial.

 Patient is unavailable for follow up.

 -

['Cardiac Disease', 'Coronary Artery Disease']


Is a Two-Film Skull X-ray Series as Sensitive as a Four-Film Series in the Diagnosis of Skull Fractures in Paediatric Patients

Summary: Minor head injuries are a common presenting complaint in the pediatric emergency department. Skull x-rays are a useful tool in the evaluation of paediatric patients with a history of minor head trauma. However, there exists ongoing controversy regarding the ideal number of views that should be obtained in a skull series. This study aims to determine if there is a significant difference in the diagnostic accuracy of skull x-rays in the diagnosis of fracture in paediatric minor head trauma patients when a 2-film series as opposed to a 4-film series is provided to participating pediatric emergency physicians.
Inclusion criteria: inclusion criteria:

 Children who had a radiography for head trauma

Exclusion criteria: :

 None


Encouraging Mail Order Pharmacy Use to Improve Outcomes and Reduce Disparities

Summary: The investigators propose a randomized encouragement trial to encourage use of the existing mail order pharmacy services among diabetes patients with poor adherence to CVD risk factor medications in 3 health care systems: Kaiser Permanente Northern California, Harvard Pilgrim, and Kaiser Permanente Hawaii.
Inclusion criteria: inclusion criteria:

 Diabetes patients who are users of CVD risk factor medications (antihypertensive therapies, antihyperlipidemics therapies, and oral antihyperglycemic therapies),

 Diabetes patients considered to be poorly adherent to CVD risk factor medications within the prior 12 months

 Diabetes patients who have not used the mail order pharmacy to fill any prescribed medications at least once in the prior 12 months
Exclusion criteria:

['Standardized intervention', 'Usual care']


An Observational Cross-sectional Study Evaluating the Use of Re-sources and the Sociodemographic and Clinical Characteristics of Patients Diagnosed With Non-valvular Atrial Fibrillation With a Risk of Stroke or Systemic Embolism on Anticoagulant Therapy and Treated in Primary Care Centers

Summary: This is a retrospective observational study to describe the sociodemographic and clinical characteristics of patients diagnosed with non-valvular atrial fibrillation (NVAF) at risk of stroke or systemic embolism, who at least three months ago changed their anticoagulant therapy, due to any clinical situation, and are currently on treatment with a direct oral anticoagulant (DOAC)
Inclusion criteria: inclusion criteria:

 Patients ≥18 years of age diagnosed with non-valvular atrial fibrillation with a risk of stroke or systemic embolism treated in primary care centres.

 Patients on regular treatment with anticoagulants who have changed their therapeutic regimen due to any clinical situation and have been on treatment with a direct oral anticoagulant for at least three months before being recruited (date of signing the in-formed consent).

 Patients whose first direct oral anticoagulant prescription is written by the specialist (cardiologist, haematologist, internist, etc.) and who are followed in primary care.

 Patients who have given their informed consent in writing.

Exclusion criteria: :

 Patients who changed their anticoagulant therapy within a period of less than three months before signing the informed consent.

 Patients with cognitive impairment preventing them from understanding what is written in the patient information sheet or the informed consent, or from per-forming the self-administered questionnaires.

 Patients who started anticoagulant therapy for non-valvular atrial fibrillation with a direct oral anticoagulant .

['Stroke', 'Prevention and Control', 'Atrial Fibrillation']

Stroke
Prevention and Control
Atrial Fibrillation


Ivabradine and Post-revascularisation Microcirculatory Dysfunction

Summary: The aim of the study is to test whether, in patients with angina and flow limiting epicardial coronary artery disease, pre-treatment with Ivabradine, as opposed to beta blockers, will reduce post percutaneous coronary intervention induced microvascular dysfunction.
Inclusion criteria: inclusion criteria:

 Symptoms of Angina Pectoris

 Angiographic evidence of epicardial coronary artery stenosis referred for PCI

 Flow limiting lesion (Fractional Flow Reserve ≤0.80) in one of following locations (as defined in SYNTAX trial89):

 Proximal or mid left anterior descending artery (LAD)

 Proximal or mid dominant right coronary artery (RCA)

 Proximal left circumflex artery (LCx) or 1ST Obtuse marginal Vessel

 Existing beta blocker prescription

 Echocardiogram performed within preceding 12 months

 Patient consent

Exclusion criteria: :

 Previous myocardial infarction (MI) in target vessel myocardial territory or any MI in preceding 12 months (defined by patient history, ECG changes and evidence of regional wall motion abnormalities on echocardiography)

 FFR>0.80 in target vessel at time of procedure

 Requirement for Multi-vessel intervention in a single procedure

 Any chronic total occlusion (100% epicardial occlusion) on angiography

 Distal coronary artery stenosis or that affecting non-dominant RCA

 Heart Rate <60 bpm at inclusion (assessed by 12 lead ECG after minimum 10 minutes rest period)

 Any rhythm other than sinus rhythm

 Sick sinus syndrome or high grade atrio-ventricular block

 Permanent Pacemaker in situ

 Congenital QT Syndrome

 Intolerance or allergy to beta-blockers

 Intolerance to Ivabradine

 Additional (other than angina pectoris) indication for beta-blocker treatment e.g. ventricular tachycardia

 Concurrent required use of rate-limiting drugs other than beta-blockers

 The necessity of combination therapy with Ivabradine and bisoprolol to achieve heart rate control

 Contraindication to Magnetic Resonance Imaging or IV adenosine

 Severe impairment of renal function (eGFR<30ml/min)

 Severe Liver Disease (Any worse than Grade A by Child-Pugh Classification)


Safety and Efficacy Study of Intravenous Immunoglobulin to Treat Japanese Encephalitis

Summary: Japanese encephalitis is caused by a viral infection of the brain transmitted by the bite of an infected mosquito. Patients with Japanese encephalitis can rapidly develop worsening conscious level and seizures. Around a third will die from the infection and half of survivors have serious long-term neurological disability. The majority of those affected are children. There are many causes of viral encephalitis, however Japanese encephalitis virus is the most common cause worldwide with over 60,000 cases annually. It occurs over much of Asia and the geographical range is expanding. There is no specific treatment for Japanese encephalitis virus, although several have been trialed. In this study we examined the effect of a new treatment, called intravenous immunoglobulin, on children with Japanese encephalitis in Nepal. Prior studies have suggested intravenous immunoglobulin may neutralize Japanese encephalitis virus and suppress damaging inflammation in the brain. It has previously been used in individual cases but never examined in a randomized trial. There was recently a trial of IVIG in West Nile encephalitis in the United States, in which Professor Solomon was on the Scientific Advisory Committee. In this study we will look if intravenous immunoglobulin is safe in this context, and that this treatment may alter the way the immune system manages the infection. Therefore, in this pilot study we will test the hypothesis that IVIG can be safely given to children with suspected JE, with no increased risk of serious adverse events compared with placebo. The aim of this proposal is to conduct a pilot safety and tolerability randomized placebo controlled trial of intravenous immunoglobulin (IVIG) in patients with Japanese encephalitis, to explore the relationship between JEV viral load, pro-inflammatory markers called cytokines and blood brain barrier markers, and the effect of IVIG on these relationships.
Inclusion criteria: inclusion criteria:

 Children aged between 1 and 14 years who had clinically diagnosed encephalitis on the basis of history of fever that lasted less than 14 days, altered consciousness with or without a history of new onset seizures with CSF finding of white cell count less than 1000 cells/mm3 with no organisms on Gram stain and a CSF: plasma glucose ratio > 40% admitted in Kanti Children's Hospital and BP Koirala Institute of Health Sciences, Nepal.

Exclusion criteria: :

 Asexual Plasmodium falciparum parasites in blood

 Coma appears secondary to other systemic condition, eg hepatic failure, cardiac failure, toxins.

 Patients who have documented antibiotic treatment before admission and in whom partially treated bacterial meningitis appears more likely than encephalitis

 Children with simple febrile convulsions, defined as a single seizure lasting less than 15 minutes followed by full recovery of consciousness within 60 minutes.

 Pregnant or breastfeeding females

 Children with a GCS of 3/15, who were receiving artificial ventilation without signs of spontaneous respiration, and with absent oculocephalic reflex.

['Intravenous immunoglobulin [ImmunoRel™ (batch 20081217)]']


Effects of Thyroid Hormone Withdrawal on Metabolic Parameters During Radioactive Iodine Therapy in Thyroid Cancer

Summary: The incidence of differentiated thyroid cancer is increasing in Korea. A significant number of them experience severe hypothyroidism in preparation for radioactive iodine (RAI) therapy after total thyroidectomy.~Because the function of thyroid hormone is closely linked with lipid and glucose metabolism, overt hypothyroidism after thyroid hormone withdrawal during RAI therapy may induce the changes of metabolic parameters.~We investigate the effects of thyroid hormone withdrawal on metabolic and cardiovascular parameters during radioactive iodine therapy in differentiated thyroid cancer.
Inclusion criteria: inclusion criteria:

 radioiodine therapy after total thyroidectomy in differentiated thyroid cancer

 age over 18

Exclusion criteria: :

 kidney failure, liver failure, heart failure

 infection

 inflammation

 autoimmune disease

 other chronic disease


Ambien CR vs. Placebo For Treatment Of Insomnia Associated With Anxiety When Used Concomitantly With Escitalopram (Lexapro)

Summary: A comparison of Zolpidem Tartrate Extended-Release (Ambien CR)vs. Placebo in the Treatment of Insomnia Associated with Generalized Anxiety Disorder (GAD) when Used Concomitantly with Escitalopram (Lexapro - antidepressant).
Inclusion criteria: inclusion criteria:

 Male or female between the ages of 21and 64 years, inclusive;

 Women must use a medically acceptable form of contraception during the entire study period, or: be surgically sterilized, post-menopausal, agree to use double-barrier contraception throughout the study period, or must have a negative urine pregnancy test prior to randomization;

 Must meet the diagnostic requirements of Generalized Anxiety Disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders;

 Score at least 18 on the Hamilton Rating Scale for Anxiety (HAM-A)

 Must be either newly diagnosed or show symptoms of relapse during a period of no drug therapy for anxiety.

 Subject must experience sleep disturbances at least three nights per week, for at least one month prior to study entry, based on historical data.

 Subject must be stabilized on all long-term medication therapy for at least one month prior to study entry.

 EXCLUSION

 History of Post-Traumatic Stress Disorder;

 Concomitant Major Depressive Disorder or Bipolar Disorder;

 Any abnormal pre-study laboratory values that require clinical intervention

 Shift work or requirement for a regular change in sleep schedule by at least six hours within the previous month.

 Pregnant or breastfeeding

 History of drug addiction, alcoholism, or drug abuse

 Currently using a benzodiazepine or SSRI or more than 2 days of use within the 28 days preceding randomization.

 A positive urine drug screen for compounds that would interfere with the assessment of a hypnotic.

 Use of prescription and non-prescription sedative drugs;

 Prior failure to respond to escitalopram therapy for anxiety

 The presence of any untreated or uncompensated clinically significant renal, endocrine, gastrointestinal, hepatic, respiratory, cardiovascular, other neurologic, hematologic, oncologic, immunologic, cerebrovascular disease or malignancy.

 History of sleep apnea

 History of myasthenia gravis

 Known hypersensitivity and/or allergy to or previous adverse experience with zolpidem or escitalopram or any of their excipients

 Subject is currently participating in another clinical trial (or within 28 days of screening).
Exclusion criteria:


Clinical Trial With Mesalamine 1g Suppositories

Summary: An Investigator-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Establish Therapeutic Equivalence of 1000 mg Mesalamine Rectal Suppositories and Canasa® Rectal Suppositories (1000 mg Mesalamine, USP) in the Treatment of Mild to Moderate Ulcerative Proctitis will be conducted in 533 patient with a estimated duration of 18months.
Inclusion criteria: inclusion criteria:

 1. Adults, male and female, 18 to 65 years of age 2. Active, mild to moderate UP, with disease activity not to exceed 15 cm beyond the anal verge: the upper disease boundary will be confirmed by flexible sigmoidoscopy/colonoscopy performed within 14 days of the Baseline Visit 3. Newly diagnosed or newly relapsed UP, where newly relapsed UP is defined as UP that has relapsed within less than and equal to 6 weeks prior to the Baseline Visit 4. A Disease Activity Index (DAI) score greater than or equal to 4 and less than or equal to 10 at the Baseline Visit; the DAI must include a Physician's Global Assessment (PGA) sub-score of less than or equal to 2, a rectal bleeding sub-score of greater than or equal to 1 and a mucosal appearance sub-score of greater than or equal to 1 5. Histological confirmation of UP with a Histological Disease Activity Score > or equal to 1 for the biopsy taken from the most severe area of disease during the flexible sigmoidoscopy/colonoscopy performed within 14 days of the Baseline Visit 6. For female patients of child-bearing potential, a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit; all female patients will be considered of child-bearing potential unless they are post-menopausal for at least one year or have been surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) 7. Female patients of childbearing potential must be practicing one of the following methods of birth control and must agree to continue with regimen throughout the study: hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of one full cycle (based on the patient's usual menstrual cycle period) before investigational product administration; total abstinence from sexual intercourse (since the last menses before investigational product administration); intrauterine device; double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream); Male patients must also agree to use acceptable methods of birth control with their female partners, and this may include use of a male condom plus spermicide. 8. Ability to give written informed consent 9. Ability and willingness to comply with study requirements, including dosing procedures, diary completion, and study visits

Exclusion criteria: :

 1. Known history of allergic reaction or clinically significant intolerance to aspirin or salicylate derivatives (including mesalamine) or non-active ingredients of the investigational product 2. Onset of UP relapse >6 weeks prior to the Baseline Visit for patients experiencing a relapse of their UP (i.e., patients who are not newly diagnosed) 3. Severe UP as defined by a DAI score of greater than or equal to 11 or a PGA sub-score of 3 4. Histological Disease Activity Score > or equal to 1 for the biopsy taken from the normal tissue above the disease margin during the flexible sigmoidoscopy/colonoscopy performed within 14 days of the Baseline Visit 5. UP with disease involvement greater than 15 cm beyond the anal verge as confirmed on flexible sigmoidoscopy/colonoscopy 6. Prior unsuccessful treatment of active UP or active ulcerative colitis with rectally administered mesalamine preparations of any strength 7. Any prior treatment of UP or ulcerative colitis with any oral 5-aminosalicylic acid product if used at >2 g/day, regardless of treatment outcome 8. Use of local, rectally administered therapies for UP or ulcerative colitis (e.g., suppositories or enemas containing mesalamine, etc.) within 30 days of the Baseline Visit 9. Use of any of the following medications: - Biological therapies (e.g., infliximab) within 90 days of the Baseline Visit - Immunosuppressive/immunomodulating (e.g., azathioprine) medications within 90 days of the Baseline Visit - Oral, intravenous, intramuscular, or rectally administered corticosteroids within 30 days of the Baseline Visit; the use of intranasal and/or inhaled corticosteroids is permitted - Oral 5-aminosalicylic acid products within 7 days of the Baseline Visit, if used at & less than or equal to 2 g/day - Oral, intravenous, or intramuscular antibiotics within 7 days of the Baseline Visit - Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within 7 days of the Baseline Visit; low-dose aspirin (less than or equal to 325 mg/day) taken for cardio-protective reasons is permitted - Antidiarrheals, antispasmodics, and iron therapy within 7 days of the Baseline Visit - Transdermal nicotine products within 7 days of the Baseline Visit 10. A change in regimen (i.e., dosage or frequency of use) of permitted medications within 30 days of the Baseline Visit, or any plans to change the regimen during the course of this study 11. Use or treatment with an investigational drug, therapy, or device within 30 days of the Baseline Visit 12. A planned change in tobacco usage (e.g., smoking, oral tobacco) during the study 13. Female patients who are pregnant, planning a pregnancy, or who are breastfeeding 14. Diseases interfering with the DAI assessment, including but not limited to, hemorrhoids and anal fissures 15. History of Crohn Disease, short bowel syndrome, or bowel surgery (except appendectomy), or active peptic ulcer 16. A positive stool culture for enteric pathogens (Salmonella, Shigella, Yersinia, Campylobacter, Vibrio, E. coli O157/H7), detection of Clostridium difficile toxin through immunoassay, or enteric parasites and their ova (including Giardia, Cryptosporidium, and Entamoeba histolytica) on routine microscopy at the Screening Visit 17. Significant impairment of renal or hepatic function, as defined by any of the following: - Creatinine >1.5 x Upper Limit Normal (ULN) - Alanine Amino Transferase (ALT) >2.5 x ULN - Aspartate Amino Transferase (AST) >2.5 x ULN 18. Serologic positivity for the Hepatitis B virus (HBV), the Hepatitis C virus (HCV), the Human Immunodeficiency Virus (HIV), or Treponema pallidum (the causative agent of syphilis) 19. Known history of idiopathic / chronic pancreatitis 20. History of active drug or alcohol abuse within the past year, or physical examination findings indicating the same 21. Current clinically significant urinary tract obstruction 22. History of coagulation disorders, including those requiring treatment with anticoagulant drugs (except for aspirin taken at ≤325 mg/day for cardio-protective reasons 23. Current active malignancy or history of malignancy within the past five years, except for cervical carcinoma in situ, squamous or basal cell carcinoma of the skin that has been surgically removed, or prostate cancer that is being managed by watchful waiting (observation alone) 24. History of pelvic irradiation 25. Any other clinically significant abnormal medical condition that in the Investigators judgment would put the patient at increased risk of illness or injury, would interfere with study participation or would interfere with the evaluation or quality of the data 26. Inability or unwillingness to understand and comply with the requirements of the protocol for any reason, including dosing procedures and visit requirements 27. Previous randomization in this study


Event Related Potentials in Borderline Personality Disorder and Major Depression

Summary: This study examines whether depression in people with borderline personality disorder is different than depression in people without borderline personality disorder.~Unlike people who have depression alone (i.e. without borderline personality disorder), people with borderline personality disorder have depressions that often do not improve with medications. This makes treating depression much more challenging in someone with borderline personality disorder than without borderline personality disorder.~Borderline personality disorderis associated with difficulty in understanding and communicating feelings. Impaired emotion processing may reflect dysfunction of an area of the brain, the anterior cingulate.~Depression is associated with changes in anterior cingulate activity. The investigators believe that when borderline personality disorder is present with depression, brain activity changes in the anterior cingulate will not be the same as in depressed patients without borderline personality disorder.~An electroencephalogram records brain electrical activity. In this study, the investigators will measure electroencephalogram indices reflecting anterior cingulate activity.~HYPOTHESIS: In this study, the investigators predict that when borderline personality is present with depression, electroencephalogram indices of anterior cingulate activity will be different from when depression is present alone (without borderline personality). This could help to explain why people with borderline personality have depressions that are harder to treat than depressions in people without borderline personality.~The investigators also predict that electroencephalogram indices of the anterior cingulate will reflect emotional processing ability, as measured by validated questionnaires.
Inclusion criteria: inclusion criteria:

 age between 18 and 45

 female

 noncontrols diagnosis: major depression &/or borderline personality disorder

 Control participants should have neither major depression or borderline pers.

 meet Structured Controlled Interview for DSM - II cut off scores

 meet Beck Depression Inventory (BDI)cut off scores

 meet Borderline Evaluation of Severity Over Time(BEST) cut off scores.

Exclusion criteria: :

 based on having none of the below diagnoses from patient history, prior clinical records and based on MINI Plus International Neuropsychiatry Interview

 schizophrenia

 psychosis

 Attention Deficit Hyperactivity Disorder

 Obsessive Compulsive Disorder

 bipolar disorder

 mental retardation

 dementia

 CNS disease

 Post-Traumatic Stress Disorder in non-borderline personality disorder groups

 Recreational drug or alcohol use in the past week.

['Borderline Personality Disorder', 'Major Depression']

Borderline Personality Disorder
Major Depression


Trial Using 125I Embedded Stent in Patients With Advanced Esophageal Cancer

Summary: More than half of patients with esophageal cancer are inoperable because of late stage cancer or metastasis and they have to undergo palliative treatments. Dysphagia is the major symptom of patients with inoperable esophageal cancer. To relieve the dysphagia and improve the quality of life of such patients, stent placement has been widely accepted to be an option for palliation of the symptoms. However, recurrence of the neoplastic stricture remains a challenge after stent placement. To combine the advantages of the immediate relief of the esophageal dysphagia with the stent placement and radiation therapy with brachytherapy, a novel esophageal stent loaded with 125I seeds has been developed in the authors' institute. The preliminary clinical trial in a single institute has demonstrated better results than the conventional stent. This prospective multiple center trial is designed to further demonstrate the clinical outcomes with this irradiation, stent in patients compared to those using a conventional covered stent.
Inclusion criteria: inclusion criteria:

 Histologically confirmed primary cancer of esophagus,

 Must be dysphagia caused by esophageal cancer,

 Without esophageal fistulas,

 Must be an inpatient,

 Life expectancy is over 6 months

Exclusion criteria: :

 Esophageal fistulas,

 Tracheal compression with symptoms,

 WBC <2000/mm3 and Platelet count <50,000/mm3,

 Concurrent therapies after stenting:surgery, chemotherapy,radiotherapy, Traditional Chinese Medicine


Errors in Prescription Antibiotics in Ventilator-associated Pneumonia

Summary: The infection is a major risk to hospitalized patients, especially those admitted to the Intensive Care Unit (ICU) and an unfavorable factor in the outcome of critically ill patients, increasing costs and prolonging hospitalization hospitalar. The ventilator-associated pneumonia (PAV) is considered the most prevalent nosocomial infection in the ICU, occurring in 9% to 68% of patients with prosthetic ventilatória.Due to the high rate of PAV and mortality related to it, is very important both prescription and administration of antibiotics correctly, as deescalation or escalation according the result of cultures.Therefore, the objectives of this study is assess if whether the antibiotic prescribed of ventilator-associated pneumonia following the orientation of literature. Will also be assessed the rate of PAV in patients critically ill adults, the main microorganisms responsible by PAV and determining antimicrobial susceptibility.
Inclusion criteria: inclusion criteria:

 Be 18 years of age;

 Having the diagnosis of ventilator-associated pneumonia.

Exclusion criteria: :

 Be under 18 years of age;


Systemic Consequences and Comorbidities in Mild/Moderate Chronic Obstructive Pulmonary Disease (COPD), Time for Action!

Summary: The aim of this prospective case-control study is to investigate the prevalence, severity and incidence of systemic consequences in newly detected patients with mild and moderate Chronic obstructive pulmonary disease (COPD). Special attention will be paid to skeletal muscle dysfunction and physical inactivity as these factors are, together with smoking, potentially modifiable.
Inclusion criteria: inclusion criteria:

 age 40-80 years old

 cases: spirometry (post-bronchodilator) based diagnosis of COPD (GOLD criteria) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment.

 smoking controls: no COPD (spirometry based) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment.

 non-smoking controls: no COPD (spirometry based) + < 1 pack year

Exclusion criteria: :

 Respiratory disorder other than COPD

 α1-antitrypsin deficiency

 Known history of significant inflammatory disease other than COPD

 COPD exacerbation within 4 weeks prior to study

 Lung surgery

 Recent diagnosis of cancer

 Therapy with oral corticosteroids in the last 6 weeks

 Significant cardiovascular comorbidity

 Significant orthopedic/musculoskeletal problems

['Chronic Obstructive Pulmonary Disease']


Amyloid and Tauopathy PET Imaging in Acute and Chronic Traumatic Brain Injury

Summary: The potential long-term effects of Traumatic Brain Injury (TBI) are poorly understood. Repeated concussions have been associated with an elevated incidence of Alzheimer's disease (AD) along with a reduced age of onset. As repetitive TBI has been studied, a syndrome has now been identified: chronic traumatic encephalopathy (CTE). There are growing concerns about the long-term neurologic consequences of head impact exposure from routine participation in contact sports (e.g., boxing, football). Brain autopsies of athletes with confirmed CTE have demonstrated tau-immunoreactive neurofibrillary tangles and neuropil threads (known as tauopathy). The relationship between exposure to repetitive head impact and the subsequent development of chronic neurodegenerative disease has not been established. Further, as the diagnosis of CTE (defined by the presence of tauopathy) is presently made after death at autopsy, clinical tools and biomarkers for detecting it remain to be defined.~With the advent of FDA-approved PET amyloid imaging, clinicians and researchers are now able to estimate plaque density in the brains of living patients. However, there are critical limitations to amyloid imaging. Current evidence suggests that markers of the presence and severity of tauopathy may be able to address these limitations. The study will utilize both [18F] Florbetapir and [18F]-T807 PET imaging to investigate amyloid and tau accumulation in subjects with a history of concussions. In order to determine whether problems with cognition and memory are seen within the populations defined for the study, the researchers will administer a core battery of neurocognitive testing. This battery will assess cognitive abilities commonly affected by TBI, including processing speed, reaction time, new problem-solving, executive functions, attention and concentration, and learning and memory. These tests, in conjunction with the imaging, will be able to determine whether regional brain activity is associated with specific cognitive problems. The researchers will obtain PET and neurocognitive data in 3 cohorts: subjects with a history of TBIs, subjects with mild cognitive impairment (MCI) and no TBI history, and healthy controls.~The investigators aim to determine whether individuals with TBI are on the same trajectory of neurodegenerative disease seen in AD or in CTE. Because of the overlap in clinical/cognitive and some behavioral symptoms in AD and CTE, an additional biomarker tool is needed to prevent misdiagnosis. Accurate diagnosis is crucial in order to provide patients with appropriate treatment.
Inclusion criteria: inclusion criteria:

 males between 40 to 85 years of age

 individuals who participated in contact sports (e.g., active and retired NFL players, NHL players, boxers, NCAA athletes) and other individuals (including but not limited to veterans, breachers, or law enforcement officials with multiple blast exposures) who all have a history of one or more concussions and have a memory or cognitive complaint

 individuals with Mild Cognitive Impairment (MCI) and no history of concussion or TBI

 healthy controls with no history of head injury and no current cognitive or memory problems

 all participants require a study partner, who is well acquainted with the participant, to answer questions either in person or over the telephone about the individuals' activities of daily living, and to corroborate cognitive problems and past history of brain injury

Exclusion criteria: :

 any significant neurological disease, such as Alzheimer's disease, Parkinson's disease, vascular dementia, Huntington's disease, Pick's disease, Lewy Body Dementia, frontotemporal dementia, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, or multiple sclerosis

 any significant systemic illness or unstable medical condition, including: uncontrolled diabetes mellitus, uncorrected hypothyroidism or hyperthyroidism, or systemic cancer

 a history of schizophrenia or psychosis, alcohol or substance abuse or dependence within the past 6 months

 clinically significant impairment of liver or renal function

 significant cerebrovascular disease

 impairment of visual or auditory acuity sufficient to interfere with completion of study procedures

 education level < 10 years

 any subjects with a history of risk factors for Torsades de Pointes, or subjects taking drugs known to prolong the QT interval

 subjects who have had 2 or more PET scans within the past year, or other significant exposure to radiation (i.e., radiation therapy)

['Traumatic Brain Injury', 'Chronic Traumatic Encephalopathy', 'Mild Cognitive Impairment']

Traumatic Brain Injury
Chronic Traumatic Encephalopathy
Mild Cognitive Impairment


Brain Regulation of Appetite in Twins

Summary: Scientists are examining the genetic and environmental influences on appetite and weight gain. The main purpose of this study is to look at how genetic and environmental factors may influence how the brain regulates appetite and food intake. Understanding how the brain regulates appetite and food intake may eventually lead to new ways to help people avoid obesity or lose weight.
Inclusion criteria: inclusion criteria:

 Ability and willingness to come with their twin to the University of Washington (Seattle)

 Additional Criteria for Aim 1 random sample only: Member of randomly selected MZ pair or

 Additional criteria for Aim 2 random sample only: One member of MZ or same-sex DZ pair with BMI of at least 30 kg/m^2

 Additional criteria for Aim 3 sample only: Member of randomly selected MZ pair, and not BMI discordant ≥ 5 kg/m^2

Exclusion criteria: :

 History of weight loss surgery or active participation in weight loss program

 Major medical problem (e.g., diabetes, cancer)

 Current use of weight loss medications or other medications known to alter appetite

 Pregnancy or menopause

 MRI contraindication (i.e., implanted metal, claustrophobia)

 Lifetime eating disorder

 Current smoking

 Current heavy alcohol use (≥2 drinks per day for females and ≥ 3 drinks per day for males)

 Self-reported weight >330 pounds at time of phone screening. MRI cannot accommodate all shapes or weights. Inability to have MRI does not exclude subject from participating in other study procedures.

 BMI < 18.5 or > 45 kg/m^2

 Allergies to study foods or inability to taste

 Twins were raised apart

 Co-twin not eligible or not willing to participate

['Functional Magnetic Resonance Imaging', 'Dual Energy X-ray absorptiometry', 'Questionnaires', 'Mood and Appetite Ratings', 'Test Meals', 'Computer Tests', 'Intravenous Catheter (IV) placement']

Functional Magnetic Resonance Imaging
Dual Energy X-ray absorptiometry
Questionnaires
Mood and Appetite Ratings
Test Meals
Computer Tests
Intravenous Catheter (IV) placement


Agreement Between Arterial, Central Venous, and Peripheral Venous Lactate in the Intensive Care Unit

Summary: The main objective of this study is to examine the agreement between arterial, central venous, and peripheral venous lactate values in a population of medical Intensive Care Unit (ICU) patients.
Inclusion criteria: inclusion criteria:

 Adult patients 18 years or older

 Admitted to the Intensive Care Unit (ICU)

 Determined by their treating clinicians to require both a central venous line and arterial line

Exclusion criteria: :

 None


Safety and Efficacy Study of Ibuprofen l-Lysine Solution in Premature Infants for Treatment of PDA

Summary: The purpose of this study is to determine the safety and effectiveness of ibuprofen l-lysine iv in premature infants in the early treatment of Patent Ductus Arteriosus.
Inclusion criteria: inclusion criteria:

 Premature newborn infant of either gender with a birth weight of 500 to 1000 grams, appropriate for gestational age;

 Non-symptomatic PDA with evidence of ductal shunting documented by an echocardiogram (ECHO);

 Less than 72 hours of age at the time of randomization;

 If infant is one of a multiple birth, he/she is one of the two (2) oldest infants who meet the eligibility criteria;

 Consent form signed by parent.

Exclusion criteria: :

 Either major congenital malformations and/or chromosomal anomalies;

 Proven, severe congenital bacterial infection;

 Maternal antenatal nonsteroidal anti-inflammatory drug (NSAID) exposure < 72 hours prior to delivery;

 Treatment with pharmacological replacement steroid therapy at anytime since birth;

 Unremitting shock requiring very high doses of vasopressors (i.e. inability to maintain mean arterial blood pressure appropriate for gestational age ± 2 SD using volume and maximal vasopressor therapy as defined by the individual institution);

 Renal failure or oliguria defined as urine flow rate < 0.5 mL/kg/hr in the 8 hours prior to randomization (Anuria is acceptable if infant is in first 24 hours of life);

 Platelet count < 75,000/mm 3;

 Clinical bleeding tendency (i.e. oozing from puncture sites);

 Expected survival less than 48 hours in the opinion of the attending neonatologist;

 Participation in other clinical intervention trials. Exceptions may be made if approved by Medical Director or designee, RPD Pharmaceutical Department;

 Symptomatic PDA as documented by 3 of the following 5 criteria

 Bounding pulse

 Hyperdynamic precordium

 Pulmonary edema

 Increased cardiac silhouette

 Systolic murmur Or, in view of the neonatologist is deemed to have a hemodynamically significant ductus.

 Exposure to NSAIDs at any time since birth.

['ibuprofen l-lysine iv solution (NeoProfen (R) )']


Noninvasive Continuous Positive Airway Pressure (NCPAP) in Children

Summary: In critically ill pediatric patients with Acute Respiratory Failure (ARF), Noninvasive Continuous Positive Airway Pressure (NCPAP) is applied to avoid intubation and all related complications such as tracheal injury and predisposition to nosocomial pulmonary infections. The choice of the interface is one of the crucial issues affecting treatment outcome in pediatric age and in particular in preschool children in whom intolerance frequently compromise noninvasive respiratory treatment. NCPAP is applied either through nasal or facial tight fitting masks and the most important principle in guiding the selection of an interface is that it should fit comfortably. However, while nasal mask can leak gas when the infant opens his/her mouth, facial mask can cause significant gastric distension and vomiting, with risk of aspirating gastric contents. Moreover, complications such as air leaks, skin irritation on the bridge of the nose, and discomfort reported with nasal or facial masks in children frequently lead to interruption of the respiratory treatment. Thus, improving the interface between the patient and the ventilator would be expected to facilitate longer and more effective application of NCPAP.~A new small helmet specifically designed for young infants has been recently introduced to administer NCPAP. In a recent short term crossover physiological randomized controlled trial, the investigators found that NCPAP by helmet was associated with enhanced feasibility, less need of sedation and prolonged application time (see references below). The purpose of this prospective randomized multicenter study is to compare the efficacy and feasibility of NCPAP delivered either by helmet or by facial mask to treat acute respiratory failure in infants admitted to Pediatric Intensive Care Unit (PICU).
Inclusion criteria: inclusion criteria:

 PaO2/FiO2 ratio <300

 Respiratory rate >50 breaths/min

 Chest x-ray compatible with pulmonary infection

 No clinical improvement after breathing oxygen at 8 l/min or more for at least 15 min

Exclusion criteria: :

 Presence of an endotracheal tube or a tracheostomy before PICU admission

 Facial deformities

 Upper airway obstruction

 Cyanotic congenital heart disease

 Facial trauma

 Recurrent apnea

 Neuromuscular weakness

 Pulmonary hypoplasia

 Pulmonary vascular anomalies

 Imminent respiratory or cardiac arrest

 COPD and/or chronic CO2 retention

 Status asthmaticus

 Pneumothorax

 Hemodynamic instability

 Alteration in consciousness with a Glasgow coma score (GCS) <10

 Aspiration or excessive bronchial secretions

 Enrollment in other research protocol

['NCPAP by helmet', 'NCPAP by facial mask']


Effects of Brain Stimulation on Learning and Reasoning

Summary: Imaging studies of the brain have revealed the different areas involved in the processes of learning and reasoning. However, the specific role these regions play in these processes, or if stimulating these areas can improve these processes is unknown.~Researchers would like to use repetitive transcranial stimulation (rTMS) to better understand the roles of individual brain regions on the processes of learning and reasoning. Repetitive transcranial magnetic stimulation (rTMS) involves the placement of a cooled electromagnet with a figure-eight coil on the patient's scalp, and rapidly turning on and off the magnetic flux. This permits non-invasive, relatively localized stimulation of the surface of the brain (cerebral cortex). The effect of magnetic stimulation varies, depending upon the location, intensity and frequency of the magnetic pulses.~The purpose of this study is to use rTMS to help determine the roles of different brain regions in the development of implicit learning of motor sequences and analogic reasoning. In addition, researchers hope to evaluate if stimulation of these regions speeds up the process of learning or analogic reasoning.
Inclusion criteria: inclusion criteria

 Right handed normal volunteers (18-65 years old).

 Patients with Parkinson's disease off medication.

 Patients with cerebellar deficits.

 Patients with frontal lobe lesions.

 Patients with frontal lobe dementia.

Exclusion criteria:

 Subjects with personal or family history of seizures or other neurological disorders.

 Pregnant women.

 Volunteers or patients with severe coronary artery disease.

 Metal in the cranium except mouth.

 Intracardiac lines.

 Increased intracranial pressure as evaluated by clinical means.

 Cardiac pacemakers.

 Intake of neuroleptics.

['Cadwell Rapid Rate Magnetic Stimulator']

['Cerebellar Disease', 'Dementia', 'Healthy', "Parkinson's Disease"]

Cerebellar Disease
Dementia
Healthy
Parkinson's Disease


Carbon Monoxide Levels and Sickle Cell Disease Severity

Summary: Background:~- Some people with sickle cell disease have different health problems than others. This may be related to how easily and frequently the red blood cells break apart in the blood. Researchers want to test breath and blood samples from people with sickle cell disease to look for very small amounts of carbon monoxide, which is produced when red blood cells break apart. They will compare these results with breath samples from healthy volunteers. Studying different levels of carbon monoxide may help predict what health problems a person with sickle cell disease may get. It may also provide more information on possible treatments.~Objectives:~- To study breath carbon monoxide levels and their possible relation to the severity of sickle cell disease.~Eligibility:~Individuals at least 18 years of age with sickle cell disease.~Healthy volunteers who are matched for age, sex, and race with the sickle cell disease group.~Design:~Participants will be screened with a medical history.~Participants with sickle cell disease will provide a blood sample and have a heart function test. They will also breathe into a bag to provide an exhaled breath sample.~Healthy volunteers will provide an exhaled breath sample.~No treatment or care will be provided as part of this study.
Inclusion criteria: ELIGIBILITY CRITERIA:

 All volunteer subjects must be at least 18 years of age and have provided informed, written consent for participation in this study. Eligibility in the study is determined prior to enrollment on the basis of the following inclusion and
Exclusion criteria: . Laboratory values obtained within the preceding 60 days are sufficient for screening purposes.

 inclusion criteria for SCD Cohort

 Males or females 18 years of age or older

 Diagnosis of sickle cell disease (any form; electrophoretic or HPLC documentation is required)

['Sickle Cell Disease', 'Sickle Cell Anemia', 'Anemia, Sickle Cell']

Sickle Cell Disease
Sickle Cell Anemia
Anemia
Sickle Cell


A Clinical Evaluation of the XIENCE PRIME Small Vessel Everolimus Eluting Coronary Stent System in Japanese Population

Summary: The purpose of this study is to evaluate the safety and effectiveness of the AVJ-09-385 Small Vessel Everolimus Eluting Coronary Stent System (EECSS) (2.25 mm diameter stent) in treatment of subjects with ischemic heart disease caused by de novo lesions.
Inclusion criteria: inclusion criteria:

 Subject must be at least 20 years of age.

 Subject or a legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements.

 Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia).

 Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.

 Subject must agree to undergo all protocol-required follow-up procedures.

 Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.

 Angiographic inclusion criteria

 One (target) or two (one target and one non-target) de novo lesions each in a different epicardial vessel.

 Lesion(s) must be located in a major artery or branch with a visually estimated diameter stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1.

 Lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of ≥ 2.25 mm and < 2.5 mm.

 Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 22 mm.

Exclusion criteria: :

 Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK and CK-MB have not returned to within normal limits at the time of procedure.

 The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.

 Subject has current unstable cardiac arrhythmias associated with hemodynamic instability.

 Subject has a known left ventricular ejection fraction (LVEF) < 40% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary).

 Subject has received coronary brachytherapy in any epicardial vessel.

 Subject has received any organ transplant or is on a waiting list for any organ transplant.

 Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure.

 Subject is receiving or scheduled to receive planned radiotherapy to the chest/mediastinum.

 Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.).

 Subject is receiving chronic anticoagulation therapy (e.g., heparin, warfarin).

 Subject will require Low Molecular Weight Heparin (LMWH) post-procedure.

 Subject has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.

 Elective surgery is planned within 6 months after the procedure that will require discontinuing either aspirin or clopidogrel.

 Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a white blood cell (WBC) of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis).

 Subject has known renal insufficiency (examples being but not limited to serum creatinine level ≥ 2.0 mg/dL, or on dialysis).

 Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.

 Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months.

 Subject has had a significant gastro-intestinal or significant urinary bleed within the past six months.

 Subject has extensive peripheral vascular disease that precludes safe 5 French catheter insertion.

 Subject has other medical illness (e.g., cancer) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).

 Subject is currently participating in another clinical study that has not yet completed its primary endpoint.

 Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test*.

 Whether a subject who met this criterion will be asked for pregnancy test will be decided per site standard. However, subject enrollment in the study is not allowed without pregnancy test result.

 Angiographic

['Vascular Disease', 'Myocardial Ischemia', 'Coronary Artery Stenosis', 'Coronary Disease', 'Coronary Artery Disease', 'Coronary Restenosis']

Vascular Disease
Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis


Safety and Efficacy Study of Lithium in Bipolar Disorder

Summary: The purpose of this study is to determine whether Lithium is safe and effective in the treatment of Bipolar I Disorder subjects with symptoms of acute mania.
Inclusion criteria: inclusion criteria:

 Diagnosis of Bipolar 1 Disorder;

 Hospitalized or in the process of being hospitalized for a manic or mixed episode

Exclusion criteria: :

 History of rapid cycling;

 History of hypersensitivity or adverse reaction to lithium


Vaccine Therapy in Treating Patients With Metastatic Cancer

Summary: RATIONALE: Vaccines made from a peptide may make the body build an immune response and kill tumor cells.~PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic cancer that has not responded to previous therapy.
Inclusion criteria: PROTOCOL ENTRY CRITERIA:

 --Disease Characteristics-- Histologically documented metastatic cancer of one of the following types: Cutaneous melanoma Ocular melanoma Colorectal carcinoma Non-small cell lung cancer Breast carcinoma Sarcoma HLA-Cw*0702 positive MAGE-12 expression by RT-PCR amplified tissue analysis Failed prior standard therapy Measurable or evaluable disease No renal carcinoma Hormone receptor status: Not specified --Prior/Concurrent Therapy-- Biologic therapy: At least 3 weeks since prior biologic therapy for cancer No other concurrent biologic therapy for cancer Chemotherapy: At least 3 weeks since prior chemotherapy for cancer and recovered No concurrent chemotherapy for cancer Endocrine therapy: At least 3 weeks since prior hormonal therapy for cancer No concurrent hormonal therapy for cancer No concurrent steroids Radiotherapy: At least 3 weeks since prior radiotherapy for cancer and recovered No concurrent radiotherapy for cancer Surgery: Prior surgery for cancer allowed --Patient Characteristics-- Age: 16 and over Sex: Male or female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: Greater than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 90,000/mm3 Hepatic: Bilirubin no greater than 1.6 mg/dL AST/ALT less than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No cardiac ischemia, myocardial infarction, or cardiac arrhythmias (if receiving interleukin-2 (IL-2) therapy) Pulmonary: No obstructive or restrictive pulmonary disease (if receiving IL-2 therapy) Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No active systemic infections No autoimmune disease, known immunodeficiency disease, or active primary or secondary immunodeficiency Hepatitis B surface antigen negative HIV negative No other active major medical illnesses (if receiving IL-2 therapy)
Exclusion criteria:

['interleukin-2', 'MAGE-12 peptide vaccine', 'Montanide ISA-51']

interleukin-2
MAGE-12 peptide vaccine
Montanide ISA-51

['Lung Cancer', 'Adult Soft Tissue Sarcoma', 'Colorectal Cancer', 'Bone Cancer', 'Ovarian Sarcoma', 'Melanoma', 'Colon Cancer', 'Rectal Cancer', 'Breast Cancer', 'Eye Cancer', 'Uterine Sarcoma']

Lung Cancer
Adult Soft Tissue Sarcoma
Colorectal Cancer
Bone Cancer
Ovarian Sarcoma
Melanoma
Colon Cancer
Rectal Cancer
Breast Cancer
Eye Cancer
Uterine Sarcoma


Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder

Summary: The purpose of this study is to determine if duloxetine is effective when compared to placebo in preventing recurrence of major depressive disorder in patients who have responded to open-label duloxetine treatment.
Inclusion criteria: inclusion criteria:

 Signed the informed consent

 Meet criteria for major depressive disorder without psychotic features.

 Have a level of understanding sufficient to provide informed consent and to communicate with the investigator and site personnel.

 Have had at least one other major depressive episode prior to the one being experienced at study entry.

 You are reliable and agree to keep all appointments for clinic visits, tests and procedures required by the protocol.

Exclusion criteria: :

 You have had treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry.

 Any women who are pregnant or breast feeding.

 If you have any serious medical illnesses other than major depressive disorder.

 If you have previously participated in a clinical trial for duloxetine.

 Any previous or current diagnosis of bipolar, schizophrenia, or other psychotic disorders.


Effectiveness of Fluoxetine in Young People for the Treatment of Major Depression and Marijuana Dependence

Summary: Adolescents who are diagnosed with major depressive disorder are often also diagnosed with marijuana dependence. Fluoxetine is an antidepressant medication currently used to treat young people who are diagnosed with major depressive disorder. The purpose of this study is to determine the effectiveness of fluoxetine in treating adolescents and young adults diagnosed with both major depressive disorder and marijuana dependence.
Inclusion criteria: inclusion criteria:

 DSM-IV diagnosis of current marijuana abuse or dependence, confirmed by SCID-SUD

 DSM-IV diagnosis of current major depressive disorder, confirmed by the K-SADS

 Marijuana use of at least two days within the week prior to enrollment

 Demonstrated adequate levels of depressive symptoms within the week prior to enrollment

Exclusion criteria: :

 DSM-IV diagnosis of bipolar disorder, schizoaffective disorder, or schizophrenia

 Hypo or hyperthyroidism

 Significant cardiac, neurological, or kidney impairment

 Liver disease (SGOT, SGPT, or gamma-GTP greater than 3 times the normal level)

 Use of antipsychotic or antidepressant medication in the month prior to enrollment

 DSM-IV dependence on any substance except marijuana or nicotine; alcohol dependence, or history of drug use

 History of significant medication side effects from any SSRI antidepressant

 Pregnant

 Unable to use adequate contraceptive methods for the duration of the study

 Inability to read or understand English

['Depressive Disorder, Major', 'Cannabis Abuse']

Depressive Disorder
Major
Cannabis Abuse


Testing MST to Improve Adherence Among Youth With Chronic Poor Metabolic Control

Summary: The protocol is a randomized clinical trial providing Multisystemic Therapy (MST), an intensive home-based family psychotherapy intervention, to a group of urban adolescents with poorly controlled Type 1 diabetes and their families.
Inclusion criteria: inclusion criteria:

 a current hemoglobin A1c(HbA1c) of >8.0%

 an average HbA1c of >8.0% during the past year

 diagnosed with Type 1 diabetes for at least one year

 reside in the metro Detroit tri-county area

Exclusion criteria: :

 severe mental impairment/thought disorder

 non-English speaking patient/parent

 co-morbid major medical condition such as cystic fibrosis


A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia

Summary: The purpose of this study is to evaluate sleep onset following administration of Transcept zolpidem tartrate sublingual tablet versus placebo in adult insomnia patients.
Inclusion criteria: inclusion criteria:

 Insomnia as defined by DSM-IV criteria and supported by subject diary

 Male or female between the ages of 18-64 years

 Body mass index (BMI) between 18-34 kg/m^2

 Females of childbearing potential must use a medically acceptable method of contraception

 Capable of understanding and willing to comply with study procedures and has provided informed consent

Exclusion criteria: :

 Females who are pregnant, breast-feeding or have a positive pregnancy test

 Any circadian rhythm disorder including planned travel across several time zones during the study period

 Known hypersensitivity to Zolpidem

 Has performed regular shift work with the past several months prior to screening

 An acute clinically significant illness or surgery as determined by the PI within 30 days of screening

 Patients that have used any central nervous system (CNS) medication or other medication known to impact the sleep/wake cycle

 A history of psychiatric disorder as defined by DSM-IV

 A history of drug addiction or alcohol abuse

 Any current significant disease, unless adequately controlled with a protocol allowed medication

 Known history of HIV or Hepatitis B or C

 Patients who have received an investigational drug within several months of screening

['zolpidem tartrate sublingual tablet 3.5mg', 'zolpidem tartrate sublingual tablet 1.75mg', 'Placebo']


Case Method Education on COPD to General Practitioners

Summary: Background:~COPD is an inflammatory and chronic obstructive lung disease, mainly caused by smoking. Most patients with COPD are discovered and treated in primary health care. Co-morbidity with heart disease, hypertension, diabetes, osteoporosis and underweight is common. It is important to diagnose COPD at an early stage, primarily to motivate smoking cessation, which is the most important factor for decelerating the progress of COPD. In addition, medication and rehabilitation to reduce symptoms of COPD can be given. Previous studies in Sweden have shown poor quality of primary health care provided to patients with COPD.~As general practitioners often deal with multiple medical problems and patients' motivation when diagnosing and treating COPD we hypothesize that case method education (see description under intervention) in COPD has better effect than traditional education (see description under intervention).This study aims to examine the effect of case method education on (1) learning in COPD among general practitioners and on (2) health in their patients with COPD.~Method:~Primary health care centers (PHCC) in Stockholm will be recruited. The PHCCs will be randomized to either case method education (n=9 PHCCs) or traditional education (n=9 PHCCs) in COPD for their general practitioners. The educations will be held during two times (two hours each) within a time range of three months, covering examination and treatment of patients with COPD. At least 10.000 patients should be listed at PHCCs included. Random sampling of 45 patients with COPD at stage 2-3 will be done from each PHCC. The patients will fill in a self-assessment questionnaire including CCQ, CAT and LINQ (see outcome measures) as well as questions about medication, exacerbations and other chronic diseases. The questionnaire will be sent to the patients 1-2 months before the education and 18 months after the education. Differences in assessments in the questionnaire before and after the education will be compared between the patients listed at the PHCCs that have received case method education vs. traditional education. In addition, general practitioners (approximately, n=180) at the PHCCs will fill in a questionnaire, immediately before and 12 months after the education, covering the learning outcomes in order to study differences in learning between the two intervention groups.
Inclusion criteria: inclusion criteria:

 Primary Health Care Centers (PHCC): >10.000 patients listed. >70% permanent employed general practitioners

 Patients: Diagnosis of COPD registered at the COPD. Grade of COPD 2-3 (GOLD) at the latest spirometry completed since 2008.

Exclusion criteria: :

 None

['Case method education in COPD', 'Traditional education in COPD']

Case method education in COPD
Traditional education in COPD


Method of Endogenous TSH Stimulation in the Follow-up of Differentiated Thyroid Cancer

Summary: The treatment of differentiated thyroid cancer (DCT) includes surgery followed by radioiodine treatment. In the follow-up of patients it is necessary to induce TSH elevation to test for cancer recurrence. One of the options is to stop L-thyroxin replacement for several weeks. Current pilot study aims to induce the necessary TSH elevation by decreasing the L-thyroxin dose. The main hypothesis is that necessary TSH stimulation will be achieved during 4-6 weeks in majority of patients.
Inclusion criteria: inclusion criteria:

 Differentiated thyroid cancer

 treated by thyroidectomy and at least 1 ablation with 131-I > 5 months ago

 TSH < 4 imU/L

Exclusion criteria: :

 Pregnancy

 Known metastasis


ThoHSpEkt Thoracoscopic Ectomy of Radioactively Marked Pulmonary Nodules With Free-hand SPECT

Summary: Title ThoHSpEkt~Study Design Pilot Study concerning the technical operative methods and a phase II study concerning the radiopharmaceutical (therapeutic-explorative study with an approved drug in a new indication)~Location Kantonsspital St.Gallen~Aim Proof of feasibility of thoracoscopic ectomy of radioactively marked pulmonary nodules with the help of free-hand SPECT.~Background In the Cantonal Hospital of St.Gallen an average of 30 - 40 patients will be operated with thoracoscopic ectomy for a pulmonary nodule. When localisation of the nodule is not possible a switch to minithoracotomy is performed.~Study intervention Marking of pulmonary nodules with radioactivity. Free-hand SPECT guided surgery~Risks Risks of bronchoscopic or CT-intervention Radiation risk (minimal)~Rational for patient number 10 patients for each group are enough to prove the feasibility, to manage difficulties and to record complications~Duration approximately 24 months.
Inclusion criteria: inclusion criteria:

 age over 18 years

 Planed thoracoscopic surgery of a pulmonary nodule

 Informed consent

Exclusion criteria: :

 mental incapacity

 contraindications for this treatment

 pregnancy

['Radioactive labelling of pulmonary nodules', 'CT guided radioactive labelling', 'Electromagnetic guided bronchoscopic radioactive labelling']

['Solitary Pulmonary Nodule', 'Bronchial Neoplasms']

Solitary Pulmonary Nodule
Bronchial Neoplasms


Substrate Modification in Stable Ventricular Tachycardia in Addition to Implantable Cardioverter Defibrillator (ICD) Therapy

Summary: The main objective of this study is to compare the time from randomization to the first recurrence of any ventricular tachycardia (VT) in patients undergoing VT ablation (for stable VTs) and substrate ablation (for unstable VTs) after an initial episode of stable VT and patients not undergoing ablation, with both groups under the protection of an ICD.
Inclusion criteria: inclusion criteria:

 Coronary artery disease For the purpose of this study, coronary artery disease will be defined as the presence of a 50 % or more diameter stenosis of the left main coronary artery, or 75 % or more diameter stenosis of the left anterior descending, circumflex or right coronary arteries, or the history of a surgical or percutaneous revascularization procedure, or history of successful thrombolysis, or a history of prior myocardial infarction (e.g.: documented by Q-wave, R-reduction, aneurysm)

 Left ventricular ejection fraction ≤ 50 % as estimated by echocardiography or contrast ventriculography within the previous 30 days and evidence for old myocardial infarction (ECG, echocardiographic or venticulographic).

 One episode of documented stable clinical VT without any reversible causes

 Written informed consent

Exclusion criteria: :

 Age < 18 years or > 80 year

 Protruding LV thrombus on pre-ablation echocardiogram

 Acute myocardial infarction within the preceding 1 months

 Class IV NYHA heart failure

 Valvular heart disease or mechanical heart valve precluding access to the left ventricle

 Unstable angina

 Cardiac surgery involving cardiotomy (not CABG) within the past 2 months

 Serum creatinine > 220 mmol/L (2.5 mg/dL)

 Thrombocytopenia or coagulopathy

 Contraindication to heparin

 Pregnancy

 Acute illness or active systemic infection

 Other disease process likely to limit survival to less than 12 months

 Significant medical problem that in the opinion of the principal investigator would preclude enrollment in the study

 Participation in another investigational study

 Unwillingness to participate or lack of availability for follow-up

 Incessant VT or electrical storm

 Bundle branch reentry tachycardia as the presenting VT

 Preexisting ICD

['Substrate modification', 'VT ablation', 'ICD Implantation']

Substrate modification
VT ablation
ICD Implantation

['Ventricular Tachycardia', 'Coronary Artery Disease', 'Left Ventricular Dysfunction']

Ventricular Tachycardia
Coronary Artery Disease
Left Ventricular Dysfunction


Sertraline for the Treatment of Patients With Frontal Lobe Dementia (FLD)

Summary: Dementia refers to a condition where there is a loss of intellectual function (cognition). It is usually a progressive condition that interferes with normal social and occupational activities.~Patients with frontal lobe dementia (FLD) suffer from a destruction of the brain cells found in the frontal lobe of the brain. Loss of frontal lobe neurons can cause changes in personality, such as aggressiveness, agitation, and depression. In addition, patients with FLD may have difficulty planning tasks and may have a loss of motivation.~Researchers believe that the cells lost in the frontal lobe of the brain are responsible for producing a chemical called serotonin. Serotonin is a neurotransmitter, which means it is used by neurons to communicate with other neurons. Researchers are inclined to believe that by replacing the missing serotonin, symptoms of FLD may be relieved.~Drugs known as serotonin uptake inhibitors, help to maintain high levels of serotonin in the body. They have been used successfully to treat patients with depression and patients with violent / impulsive behaviors. Sertraline is a serotonin reuptake blocker that is relatively easy to give (once daily), is safer than most other serotonin reuptake blockers (very little effect on vital enzyme systems [cytochrome P-450]), and has few interactions with other drugs.~This study is designed to test the effectiveness of Sertraline for the treatment of symptoms associated with FLD. Patients participating in the study will receive Sertraline for 6 weeks and a placebo inactive sugar pill for 6 weeks. During the study, researchers will test psychological and neurological functions to measure the effects of the drug.
Inclusion criteria: Characterized as having behavioral manifestations using a standardized neuropsychiatric scale and interview.

 FLD patients' frontal cognitive sysfunctions characterized using a short neurobehavioral test battery.

 Patients must be able to be tested and cooperative with the procedures required in this protocol.

 No contraindications to the use of Sertraline.

 No medical conditions that can reasonably be expected to subject the patient to unwarranted risk (e.g., cancer) or require frequent changes in medication. Well-controlled medical conditions such as hypertension and diabetes will not be excluded.

 Patients must not be pregnant or nursing and must be using effective contraception, if still at child-bearing age.

 No history of prior severe traumatic brain injury or other severe neurologic or psychiatric condition, such as psychosis, stroke, multiple sclerosis, or spinal cord injury.

 Not using any psychotropic medication which cannot be stopped 4 weeks before the study.
Exclusion criteria:


Evaluation of DermStream(tm) - an Irrigation Product for Chronic Wound Management

Summary: The primary purpose of this study is to evaluate the safety of DermaStream(tm) in the management of chronic wounds.~Other goals of this study are to gain feedback from patients and healthcare providers on the ease of use (the ergonomic aspect) of the device, and to make a preliminary evaluation of the efficacy of DermaStream(tm) in chronic wound management.
Inclusion criteria: inclusion criteria:

 Diabetic ulcer, OR Venous insufficiency ulcer

 Age range: 18-80 years

 Wound max. diameter range: 1.5 - 10 centimeters

 Wound San Antonio assessment system: grade 1 and 2, stage A and B

 Palpable pulses in the Posterior Tibial and the Dorsalis Pedis arteries

 Ankle-Brachial Index > 0.7 by Doppler

 Wound present for at least 6 weeks

 Wound location: foot or calf, at a location where the device can be attached properly

 Lack of purulent discharge from the wound.

Exclusion criteria: :

 Hypoalbuminemia: Albumin < 2gr/dl

 Right-side congestive heart failure with edema of legs: +2 or higher

 Renal insufficiency: Cr > 2 mg/dl

 Abnormal liver function: ALT or AST>300

 Skin disorders adjacent to the wound, unrelated to the pathology of the wound

 Non-cooperative patient

['DermaStream(tm) application and Streaming of Saline']


Stimulus-Stimulus Pairing Study

Summary: The purpose of the current study is to deliver the SSP procedure to children diagnosed with autism that do not have vocal language. The study will also aim to gather data in the natural environment using a voice recorder.
Inclusion criteria: inclusion criteria:

 Diagnosis of autism

 Currently do not emit vocalizations or minimally verbal

 Willingness of the participant's parent/guardian to bring their child to the Marcus Autism Center for one-hour appointments, five days a week, for six weeks.

Exclusion criteria: :

 1. Children with significant problem behavior that interferes with structured intervention

['Stimulus-stimulus pairing', 'Vocal recorder']

Stimulus-stimulus pairing
Vocal recorder


The International Nocturnal Oxygen (INOX) Trial

Summary: This multicenter randomized placebo controlled trial aims to determine if in patients with COPD not qualifying for LTOT but presenting significant nocturnal arterial oxygen desaturation, whether nocturnal oxygen therapy provided for a period of 4 years decreases mortality or delay the prescription of LTOT.
Inclusion criteria: inclusion criteria:

 Patients with a diagnosis of COPD supported by a history of past smoking and obstructive disease: FEV1<70% predicted, FEV1/FVC<70% and a total lung capacity by body plethysmography >80% predicted;

 Stable COPD at study entry, as demonstrated by (1) no acute exacerbation and (2) no change in medications for at least 6 weeks before enrollment in the trial;

 Non-smoking patients for at least 6 months before enrollment in the trial;

 SpO2 at rest < 95%;

 Patients fulfilling the current definition of nocturnal oxygen desaturation, i.e., >=30% of the recording time with transcutaneous arterial oxygen saturation <90% on at least one of two consecutive recordings;

 Ability ot give informed consent.

Exclusion criteria: :

 Patients with severe hypoxemia fulfilling the usual criteria for continuous oxygen therapy at study entry: PaO2 <=55 mmHg; or PaO2 <= 59 mmHg with clinical evidence of at least one of the following: (1) with right ventricular hypertrophy (P pulmonale on ECG:3 mm leads ll, lll, aVf); (2) right ventricular hypertrophy; (3)Peripheral edema (cor pulmonale); (4) hematocrit >=55%;

 Patients with proven sleep apnea (defined by an apnea/hypopnea index of >=15 events/hour) or suspected sleep apnea on oximetry tracings;

 Patients currently using nocturnal oxygen therapy;

 Patients with known left heart or congenital heart diseases, interstitial lung diseases, bronchiectasis as the main cause of obstructive disease, lung carcinoma, severe obesity (body mass index >= 40 kg/m²), or any other disease that could influence survival.

['Chronic Obstructive Pulmonary Disease', 'Nocturnal Desaturation']

Chronic Obstructive Pulmonary Disease
Nocturnal Desaturation


Assess the Variability of Uni-Dimensional, Bi-Dimensional, and Volumetric CT Scan Measurement of Non-Small Cell Lung Cancer Tumors

Summary: The purpose of this study is to compare the results of two CT scans of the chest performed within minutes of each other. We will compare several different measurements of lung cancer tumors. This study will help show whether we can get accurate results when we compare measurements on different CT scans. This information is important for patients with cancer, who often have more than one CT scan during their treatment.
Inclusion criteria: inclusion criteria:

 Have pathologically confirmed non-small cell lung cancer

 Have measurable primary pulmonary tumors ≥ 1cm

 Have plans for a clinically indicated non-contrast CT scan of the chest

 All patients must be ≥ 18 years old

Exclusion criteria: :

 Pregnant or lactating women


Tick-borne Encephalitis and Positive Borrelial Antibodies

Summary: In Slovenia, tick-borne encephalitis and Lyme borreliosis are both endemic diseases with high incidence rates and they are both transmitted by a bite of infected Ixodes ricinus tick. In clinical practice, tick-borne encephalitis is confirmed by demonstration of tick-borne encephalitis antibodies in serum of a patient with compatible clinical presentation and cerebrospinal pleocytosis. Patients with Lyme meningitis or meningoradiculitis also have cerebrospinal pleocytosis, however the presence of borrelial antibodies in serum does not attest Lyme neuroborreliosis.~Patients with tick-borne encephalitis and positive borrelial antibodies in serum, but not fulfilling criteria for Lyme neuroborreliosis, are often being treated with antibiotics in several European countries due to the possibility of double infection. The investigators hypothesise that such patients do not benefit from antibiotics. Such an approach may appear safe regarding the possibility of borrelial infection, however it can also be associated with detrimental consequences such as antibiotic related adverse reactions, negative epidemiological impact on bacterial resistance, and intravenous catheter related complications.
Inclusion criteria: inclusion criteria:

 18 years or older

 clinical picture compatible with tick-borne encephalitis,

 clear cerebrospinal fluid,

 cerebrospinal pleocytosis (leucocytes in cerebrospinal fluid >5 x 106/)L,

 positive serum immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies against tick-borne encephalitis virus,

 positive serum IgG antibodies against Lyme borreliae.

Exclusion criteria: :

 isolation of B.burgdorferi sensu lato from cerebrospinal fluid,

 positive intrathecal borrelial antibody production index,

 seroconversion of borrelial IgG antibodies,

 presence of erythema migrans and/or borrelial lymphocytoma in the last month,

 Bannwarth syndrome.

['Doxycycline', 'Symptomatic therapy', 'Questionnaire']

Doxycycline
Symptomatic therapy
Questionnaire


E-Compared-CH: Comparative Effectiveness Research on Internet-based Depression Treatment - Swiss Trial

Summary: To compare the clinical and cost-effectiveness of blended Cognitive Behavioural Therapy (CBT) for adults with major depressive disorder (MDD) with treatment as usual (TAU) in Swiss patients in secondary care
Inclusion criteria: inclusion criteria:

 Being 18 years of age or older

 Meet DSM-IV diagnostic criteria for MDD confirmed by MINI International Neuropsychiatric Interview version 5.0

 Informed Consent

 Having access to a PC and Internet connection

 Having a Smartphone that is compatible with the mobile component of the intervention

 Understanding of the German language spoken and written

Exclusion criteria:

 Current high risk for suicide according to the MINI Interview section C

 Serious psychiatric co-morbidity: substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder, as established at the MINI interview

 Currently receiving psychological treatment for depression

 Being unable to comprehend the spoken and written language (German)

 Not having access to a PC and fast Internet connection (i.e. broadband or comparable).

 Not having a Smartphone that is compatible with the mobile component of the intervention that is offered or not willing to carry a Smartphone during the duration of treatment


DElirium prediCtIon in the intenSIve Care Unit: Head to Head comparisON of Two Delirium Prediction Models

Summary: Currently, two ICU delirium prediction models are available: the PRE-DELIRIC model and the early prediction model (E-PRE-DELRIC). However, the use of these prediction models is not yet implemented as standard in clinical practice, as it is unknown which delirium prediction model can best be used to predict delirium in ICU patients.Therefore the main aim of this study is to compare the performance of the PRE-DELIRIC model and the E-PRE-DELRIC model.
Inclusion criteria: inclusion criteria:

 ICU patients aged ≥18 years;

 Surgical, medical, neurology/neurosurgical, or trauma patients.

Exclusion criteria: :

 Delirious at ICU admission;

 Expected ICU stay shorter than 6 hours;

 Unable to reliably assess ICU delirium due to:

 sustained coma during entire ICU stay;

 unable to understand the language spoken;

 severely mentally disabled;

 serious receptive aphasia;

 serious auditory or visual disorders.


A Study of Pre-hospital Treatment of Acute Myocardial Infarction Based on Diagnosis by Interpretation of Remotely Acquired ECG and Thrombolysis With Accelerated Alteplase ( Actilyse®)

Summary: The general aim of this study was to assess the feasibility of treating acute myocardial infarction (AMI) by physician-directed pre-hospital thrombosis, using accelerated alteplase (Actilyse®) and a diagnostic technique involving remote electrocardiogram (ECG) acquisition by paramedics
Inclusion criteria: inclusion criteria:

 Ischemic cardiac pain of >= 20 minutes and <= 6 hours

 Age 18 - 80 years

 Ability to give informed consent (witnessed verbal or written)

 Ability to follow protocol and comply with follow -up requirements

Exclusion criteria: :

 Current participation in another clinical trial

 Patient will be ineligible for pre hospital administration of actilyse if any of the following apply:

 Acute myocardial infarction (AMI) treated with a thrombolytic agent within the preceding 4 days

 BP (blood pressure) > 180/100 mmHg (on one measurement)

 Significant bleeding disorder within the past 6 months

 Major surgery, biopsy of a parenchymal organ, or significant trauma (including any trauma associated with the current AMI) within 3 months

 History of stroke, transient ischaemic attack, or central nervous system structural damage (e.g. neoplasm, aneurysm, intracranial surgery)

 Oral anticoagulation

 Recent (within 10 days) non - compressible vascular puncture

 Pregnancy (positive urine pregnancy test) or lactation, parturition within the previous 30 days, or female of childbearing potential not using adequate birth control (oral contraception)

 Severe liver disease, including hepatic failure, cirrhosis portal hypertension (oesophageal varices) and active hepatitis

 Diabetes with definite history of retinopathy

 Other serious illness (e.g. malignancy, active infection)

 Bacterial endocarditis / pericarditis

 Acute pancreatitis

 Documented ulcerative gastrointestinal disease during last 3 month, arterial aneurysms, arterial / venous malformations

 Any other condition that the investigator feels would pose a significant hazard to the subject if the investigational therapy was to be initiated

 Patients who are not excluded from thrombolytic therapy by the criteria above will, in addition, need to satisfy the following 'inclusion' criteria prior to the pre - hospital thrombolysis:

 12 lead ECG criteria: ST segment elevation >= 0.1 mV in two contiguous electrocardiogram (ECG) standard leads indicative of AMI, or ST elevation >= 0.2 mV in two contiguous chest leads and all left bundle branch block (LBBB) with clinical indication of AMI

['Alteplase (Actilyse)', 'Standard therapy']


Therapeutic Effect of Tacrolimus in Combination With Low Dose Corticosteroid in Adult Patient With Minimal Change Nephritic Syndrome

Summary: The hypothesis of this study is that tacrolimus reduces the proteinuria in adult patient with minimal change nephritic syndrome.
Inclusion criteria: inclusion criteria:

 from 18yrs to 80 yrs , man and women

 Minimal change disease is diagnosed by kidney biopsy

 On screening, the patient shows that the level of urine protein/creatinine ratio is over 3.0

 On screening, the patient shows that the serum albumin is below 3.0g/dL

 the patient sign on the concent form

Exclusion criteria: :

 the patient have experience to take tacrolimus or cyclosporin for 1 month

 If it is the relapse of the nephrotic syndrome, before relapse, the maintenance dose of steroid is over 0.3 mg/kg/day

 steroid dependent or steroid resistant or frequent relapse case

 uncontrolled hypertension

 pregnancy or anticipate pregnancy with 6 month

 hypersensitivity to tacrolimus or macrolide

 acute hepatitis or the level of AST or ALT is over 2 times of normal range or the level of bilirubin is over 2.0 mg/dL


Escitalopram (Lexapro®) In Patients With Major Depression With Atypical Features

Summary: Aims of Study:~The aims of this study are 1) to examine the clinical utility of escitalopram in patients with major depression with atypical features; 2) to evaluate the tolerability of escitalopram in major depression with atypical features.~Study hypothesis and objectives. This study is proposed as an open-label study to gather pilot data to examine whether escitalopram has clinical utility in the treatment of major depression with atypical features. Because of the exploratory nature of the design, no specific study hypotheses can be generated regarding efficacy of the drug. Our primary hypothesis is that the effect size of escitalopram in atypical depression will be similar to the effect size of escitalopram in major depression, its FDA approved indication.
Inclusion criteria: inclusion criteria:

 age 18 to 65 years,

 DSM-IV episode of Major Depression non-psychotic with atypical features.

 ≥19 score on the 29-item HAM-D,

 ability to give informed consent, if patients are of child-bearing potential

 A minimum 2-week washout from existing psychotropics (5 weeks for fluoxetine).

Exclusion criteria: :

 bipolar depression,

 Any Axis I psychotic disorder

 currently suicidal or suicide risk,

 history of substance abuse in the previous 12 months,

 history of hypersensitivity to escitalopram, or citalopram

 serious or unstable medical disorders,

 starting or terminating psychotherapy during the previous 12 weeks,

 ECT treatment in the previous 3 months,

 pregnancy or planning pregnancy.