Therapy of Complicated Intra-Abdominal Infections With Moxifloxacin or Ertapenem

Summary: A study to compare the safety and efficacy of moxifloxacin to ertapenem in patients with intra-abdominal infections.
Inclusion criteria: inclusion criteria:

 Hospitalized men or women >/=18 years of age

 Expected duration of treatment with intravenous antibiotics anticipated to be >/= 5 full days but not exceeding 14 days

 Ability to provide documented and signed written informed consent

 Confirmed or suspected intra abdominal infection defined as follows:

 For a confirmed intra abdominal infection, a surgical procedure (laparotomy or laparoscopy) must have been performed within 24 hours prior to enrollment and reveal at least one of the following:

 Gross peritoneal inflammation with purulent exudates (i.e. peritonitis)

 Intra abdominal abscess

 Macroscopic intestinal perforation with localized or diffuse peritonitis

 Subjects enrolled on the basis of a suspected intra abdominal infection must have:

 Radiological evidence [abdominal plain films, computed tomography (CT), magnetic resonance imaging (MRI) or ultrasound] of gastrointestinal perforation or intra-abdominal abscess and the following signs and symptoms:

 Symptoms referable to the abdominal cavity (e.g. anorexia, nausea, vomiting or pain), lasting for at least 24 hours

 Tenderness (with or without rebound), involuntary guarding, absent or diminished bowel sounds, or abdominal wall rigidity

 At least two of the following SIRS criteria:

 Temperature > 38.0°C rectal or tympanic membrane, or temperature < 36.0°C rectal or tympanic

 Heart rate > 90/min

 Respiratory rate > 20/min

 WBC >12,000 cells/mm3 or < 4,000 cells/ mm3

 The subject must be scheduled for a surgical procedure (laparotomy or laparoscopy) within 24 hours of enrollment of the study

Exclusion criteria: :

 Known hypersensitivity to quinolones, and/or to carbapenems and/or to any other type of beta lactam antibiotic drugs (e.g. penicillins or cephalosporins), or any of the excipients

 Women who are pregnant or lactating or in whom pregnancy cannot be excluded

 History of tendon disease/disorder related to quinolone treatment

 Known congenital or documented acquired QT prolongation; uncorrected hypokalemia; clinically relevant bradycardia; clinically relevant heart failure with reduced left ventricular ejection fraction; previous history of symptomatic arrhythmias

 Concomitant use of any of the following drugs, reported to increase the QT interval: antiarrhythmics class IA (e.g. quinidine, hydroquinidine, disopyramide) or antiarrhythmics class III (e.g., amiodarone, sotalol, dofetilide, ibutilide), neuroleptics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressive agents, certain antimicrobials (sparfloxacin, erythromycin IV, pentamidine, antimalarials, particularly halofantrine), certain antihistaminics (terfenadine, astemizole, mizolastine), and others (cisapride, vincamine IV, bepridil, diphemanil)

 Known severe end stage liver disease

 Creatinine clearance </= 30 mL/min/1.73 m2

 Systemic antibacterial therapy administered for more than 24 hours within 7 days of enrollment

 Need for systemic antibacterial therapy with agents other than those described in the study protocol

 Indwelling peritoneal catheter

 Pre existing ascites and presumed spontaneous bacterial peritonitis

 Perforation of the stomach or duodenum, if the duration of perforation is less than 24 hours or if operated on within 24 hours of perforation

 Perforation of the small bowel (excluding the duodenum) or large bowel, if the duration of perforation is less than 12 hours or if operated on within 12 hours of perforation

 All pancreatic processes including pancreatic sepsis, peri-pancreatic sepsis, or an intra abdominal infection secondary to pancreatitis

 Liver and splenic abscess

 Transmural bowel ischemia or necrosis without perforation or established peritonitis or abscess

 Acute and gangrenous cholecystitis without perforation

 Acute cholangitis

 Early acute, suppurative, or gangrenous non-perforated appendicitis

 Subjects requiring antibiotic irrigations of the abdominal cavity or surgical wound

 Treatment with open abdomen or marsupialization, or multiple planned re laparotomies

 Infections originating from the female genital tract

 Peri-nephric infections

 Evidence of sepsis with shock requiring the administration of vasopressors for more than 4 consecutive hours

 Known rapidly fatal underlying disease (death expected within 6 months)

 Neutropenia (neutrophil count < 1,000/mL) caused by immunosuppressive therapy or malignancy

 Receiving chronic treatment with known immunosuppressant therapy (including chronic treatment with > 15 mg/day of systemic prednisone or equivalent)

 Subjects known to have AIDS (CD4 count < 200/mL) or HIV seropositives who are receiving HAART (HIV positive subjects may be included. HIV testing is not required for this study protocol)

 Subjects with a malignant or pre malignant hematological condition, including Hodgkin's disease and non-Hodgkin lymphoma (subjects with solid tumor can be included in the study)

 Subjects with a Body Mass Index >/= 45 kg/m2

 Previous enrollment in this study

 Participation in any clinical investigational drug study within the previous 4 weeks

['Moxifloxacin (Avelox, BAY12-8039)', 'Ertapenem intravenous']

Moxifloxacin (Avelox
BAY12-8039)
Ertapenem intravenous


REal World Information on Cardiovascular Drug Management Patterns in Acute Coronary Syndrome paTients

Summary: RE-ACT is a national, multi-centre, observational, prospective, longitudinal cohort study which will include patients hospitalized for ACS within 24 hours of symptom onset and who have a final diagnosis of ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI). This study aims to describe the short-term (at the end of the first month after index event) antithrombotic management patterns in a real-life setting for patients hospitalized with an acute coronary syndrome.
Inclusion criteria: inclusion criteria:

 Provision of subject informed consent

 Patients hospitalized and diagnosed with STEMI or NSTEMI

 Hospitalized within 24 hours of onset of symptoms or transferred from another hospital within 24 hours of the onset of symptoms

Exclusion criteria: :

 STEMI and NSTEMI precipitated by or as a complication of surgery, trauma, or GI bleeding or post-PCI.

 STEMI and NSTEMI occurring in patients already hospitalized for other reasons.

 Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances).


A CALIBER Study: Risk Factors for Stroke, Heart Failure, and Myocardial Infarction in Atrial Fibrillation

Summary: We aim to investigate the prognosis of patients diagnosed with AF, particularly in relation to the development of subsequent stroke, heart failure, and myocardial infarction. We will explore the relationship between these outcomes and a range of risk factors.
Inclusion criteria: inclusion criteria:

 Patients with a coded diagnosis for atrial fibrillation in their primary or secondary care record.

 Patients in GPRD practices which are deemed up to standard by GPRD criteria

 Patients whose records are deemed acceptable by GPRD criteria and contain at least one year of data

 Patients whose age and sex, as recorded in GPRD is the same as that recorded in HES.

Exclusion criteria: :

 A diagnosis of heart failure, stroke, or myocardial infarction occurring before diagnosis of atrial fibrillation

['Atrial Fibrillation', 'Heart Failure', 'Stroke', 'Myocardial Infarction']

Atrial Fibrillation
Heart Failure
Stroke
Myocardial Infarction


An Adhesion Reduction Plan in the Management of the Surgical Open Abdomen

Summary: The purpose of this study is to determine whether an adhesion reduction plan, consisting of early adhesion prevention and application of a bioresorbable membrane is effective in reducing the severity of adhesions and the incidence of complications in managing the open abdomen in trauma and emergency general surgery.
Inclusion criteria: inclusion criteria:

 Trauma patients with open abdomen after initial laparotomy

 Emergency surgery patients with open abdomen after initial laparotomy

 Able to obtain consent from patient or LAR before any research initiated

Exclusion criteria: :

 Seprafilm application at initial laparotomy

 Patient is a prisoner

 Inability to obtain informed consent

 Consentable person does not speak English


Treatment of Childhood Osteoporosis With Alendronate (Fosamax)

Summary: Bones grow and stay strong through a continuous process of formation (building) and resorption (break down). When more bone is formed than resorbed, the density (level of calcium) in bone increases and the bones become stronger. However, if more bone is resorbed than formed the density of bone decreases and the bones become weak. This condition is called osteoporosis.~Osteoporosis is a rare but serious condition in children. Childhood osteoporosis can occur without a known cause (idiopathic juvenile osteoporosis). Children with osteoporosis suffer from pain, inability to stay active, and increased amounts of broken bones, including fractures of the spine. Even mild childhood osteoporosis may have long-term consequences since individuals who achieve a less than normal bone composition (peak bone mass) during the first 20-30 years of life may be at an increased risk for osteoporosis as adults.~Alendronate (Fosamax) is a drug that works by stopping bone resorption (break down). It has been used to treat post-menopausal osteoporosis, male osteoporosis and adults with osteoporosis due to long-term steroid therapy. The goal of this study is to determine the effectiveness of alendronate in children with idiopathic juvenile osteoporosis. Researchers believe that children treated with alendronate will improve bone strength and decrease the amount of fractures caused by osteoporosis.
Inclusion criteria: inclusion criteria:

 Chronological age: 6.0 - 17.0 years. Study population will be restricted to children greater than 12 years of age until 8 patients have completed 6 months of the study or safety data is available from a comparable study.

 AP Lumbar spine bone mineral density less than or equal to -2 standard deviations for age matched controls (z-score) using Hologic QDR machine.

 Normative data published by Faulkner will be used to calculate Z-scores.

 Patients with Idiopathic Juvenile Osteoporosis, osteoporosis (BMD less than -2 SD compared to age-matched controls) in a child with no identifiable etiology. Children with IJO and delayed puberty will have their z-score calculated on the basis of bone age.

Exclusion criteria: :

 Inability to swallow pills or comply with administration instructions.

 Upper gastrointestinal tract disease.

 Creatinine clearance greater than or equal to 35 mL per min per 1.73 square meters.

 Prior treatment with bisphosphonates.

 Concurrent therapy with oral aspirin or salicylate containing compounds, excluding delayed-release salicylates which act in the distal gastrointestinal tract (for example, mesalamine, sulfasalazine, etc...).

 Hypocalcemia.

 Treatment with hGH or calcitonin in the preceding 6 months.

 Inability to undergo dual energy x-ray absorptiometry.

 Positive pregnancy test.

 In females, sexual activity without an effective method of contraception.


Effectiveness of Using an Oil Bath Additive

Summary: Epidermis that lacks moisture and/or sebum presents as dry skin, which is often characterized by a pattern of fine lines, scaling and itching. In dry skin, the barrier function may be compromised. Skin care practices to decrease the risk of development of dry skin and/or to improve dry skin condition have barely been investigated. Bathing with bath oils has been shown to increase skin hydration, thus helping to stabilize skin barrier function. Therefore, the aim of this study is to investigate the effect of bathing every other day on the skin barrier. Functional parameters, such as TEWL, stratum corneum hydration (SCH) and skin-pH (pH) were measured to characterize skin barrier function.
Inclusion criteria: inclusion criteria:

 Signed informed consent, or children whose parent(s) or guardian(s) have given their written informed consent for their child's participation in the study

 Child specific written informed consent, if over 7 years of age

 Subjects with a general good and stable health condition

 Subjects with clinically stable medical conditions

 Accept to abstain from sunbathing and solarium during the study

 Overall Dry Skin score (ODS) of 1 to 2 at arms and lower legs

 TEWL > 12 g/m2/h on the left mid volar forearm

Exclusion criteria: :

 Any dermatological condition or skin affection which may interfere with the study assessments, e.g. scars

 Suffering from porphyria

 Suffering from severe photodermatoses according to the judgment of the investigator

 Clinically significant, possibly unstable medical conditions such as metastatic tumor

 Currently having other malignant or benign tumors of the skin in the investigational area

 Any other acute or chronic pathology that may interfere with the study conduct in the investigator's opinion

 Known allergy or intolerance to any ingredients of the study product, e.g. propylene glycol

 Use of (medical) oil-containing bath additives or other oil-containing cleansers

 Current topical or systemic treatment affecting the skin, e.g. diuretics

 Treatment of dry and/or inflammatory skin conditions with topical corticosteroids during the 4 weeks before inclusion

 Systemic immunosuppressive or immunomodulatory therapy

 Topical retinoids applied during the 6 weeks before inclusion

 Topical application of immunosuppressive treatment during the 6 weeks before inclusion

 Therapeutic UV-Radiation during the 6 weeks before inclusion

 Increased UV-exposure during the 6 weeks before inclusion


Comparison of Digital Electronic Stethoscope to Computed Tomography (CT) Angiography in Detection of Coronary Artery Disease

Summary: The study is designed to evaluate the predictive diagnostic accuracy of SonoMedica's CardioSond digital electronic stethoscope in the detection of coronary artery disease (CAD) in patients without known disease who are referred to cardiac computed tomography angiography (CT scans).
Inclusion criteria: inclusion criteria:

 Subjects who are undergoing routine screening coronary CT angiography

 Willingness to sign informed consent form

Exclusion criteria: :

 Inability to provide informed consent form

 Age less than 21 years

 Any contraindications to coronary CT angiography

 Known atherosclerotic heart disease, including a history of prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery or an established diagnosis of CAD by prior X-ray or CT angiography

 Supraventricular or ventricular arrhythmias that would be expected to affect CT-angiography image quality (e.g., atrial fibrillation, atrial flutter, ventricular tachycardia, bigeminy, and trigeminy). Patients with isolated premature atrial contractions and premature ventricular contractions may enroll.

 Use of intravenous vasodilators

 Any pulmonary conditions that would create abnormal physical findings that would interfere with the fidelity of the cardiac sound recording (e.g., obstructive pulmonary disease, such as asthma or COPD, with audible wheezing).

 Presence of audible aortic or pulmonic diastolic murmurs, tricuspid or mitral flow diastolic murmurs, or continuous murmurs

['CardioSond Cardiac Sonospectrographic Analyzer']


nuMoM2b Heart Health Study

Summary: This study is looking at the relationship between experiences during pregnancy and cardiovascular health 2 to 3½ years later. The investigators are recruiting women from the approximately 10,000 women who were enrolled and followed over the course of their first pregnancy in another study.
Inclusion criteria: inclusion criteria:

 Interval Contact:

 Agreed to contact for future studies during nuMoM2b and not subsequently withdrawn from the cohort.

 Have pregnancy outcome data from the nuMoM2b study.

 At least 18 years of age (to begin interval contact attempts once nuMoM2b participant reaches age 18).

 Provision of verbal consent for telephone interview or acknowledgement of consent with completion of the web-based self-administered questionnaire.

 In-clinic Visit:

 Consented for participation in interval contacts and not subsequently withdrawn

 Between 2 and 3.5 years after the nuMoM2b pregnancy ended

 Self-report at least 6 months postpartum from any subsequent pregnancy

 Self-report not currently pregnant

 Able to provide informed consent

 Provision of written, signed, informed consent for the 2 to 3.5 year in-clinic assessment

 Not currently pregnant by urine pregnancy test administered in the clinic following consent

 In-home Sleep Breathing Assessment after the In-Clinic Visit:

 Participation in the in-clinic visit

 Participation in the sleep breathing substudy of nuMoM2b with at least one sleep breathing assessment providing valid data

 Not currently using positive airway pressure (PAP) therapy or other approved treatments for sleep apnea such as oral appliances and nasal therapy patch (Provent)

 Not currently on continuous oral steroid therapy for 14 days or more to treat asthma

 Not currently using oxygen supplementation to treat a medical condition

 Able to provide informed consent and deemed likely to return equipment in a reasonable period

 Provision of written, signed, informed consent for the sleep breathing assessment for the nuMoM2b Heart Health Study

Exclusion criteria: :

 Inability or refusal to provide informed consent for the study component.

['Pregnancy Complicated by Cardiovascular Disorders as Postpartum Condition, Delivered During Previous Episode', 'Breathing-Related Sleep Disorder']


Effect of Antimalarial Drugs to Rabies Vaccine for Post-exposure Prophylaxis.

Summary: This is an exploratory trial to evaluate the effect of antimalarial drugs on the immune response generated by rabies vaccine when administered for post-exposure prophylaxis. This study will use the FDA approved post-exposure prophylaxis vaccine regimen (without rabies immune globulin) in the presence or absence of an FDA-approved malaria chemoprophylaxis regimen.
Inclusion criteria: inclusion criteria:

 Provide signed and dated informed consent form.

 Willing to comply with all study procedures and be available for the duration of the study.

 Male or female, aged ≥ 18 to ≤ 60 years on day of inclusion.

 In good general health based on medical history and physical exam

Exclusion criteria: :

 Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination.

 Participation in the 4 weeks preceding the first trial vaccination, or planned participation during the present trial period, in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.

 Previous history of receiving the rabies vaccine.

 Previous history of receiving rabies immune globulin.

 Any major psychiatric disorder, such as severe depression, severe anxiety disorder, psychosis, schizophrenia, other major psychiatric disorders, or seizures. History of mild depression or anxiety disorder that are well controlled are not

['Chloroquine', 'Atovaquone and Proguanil', 'Doxycycline', 'Rabies Vaccine']

Chloroquine
Atovaquone and Proguanil
Doxycycline
Rabies Vaccine


Clinical Findings in General Paresis

Summary: This is a study of the clinical and neuroimaging of general paresis. The investigators studied six patients with general paresis.
Inclusion criteria: inclusion criteria:

 EEG MR

Exclusion criteria: :

 Serological test


A Clinical Demonstration of EEG Brain-computer Interface for ALS Patients

Summary: The goal of this VA demonstration project is to show that the Brain-computer interface (BCI) technology is a clinically practical and important new communication and control option that can improve the lives of veterans with amyotrophic lateral sclerosis (ALS). The project will test four well-supported hypotheses: (1) that people with ALS who find (or will soon find) conventional assistive technology inadequate can and will use a BCI system for important purposes in their daily lives without close technical oversight, 2) they will continue and even increase this use throughout the period of the study, (3) that BCI use will improve their lives, and 4) BCI will improve the lives of their families and caregivers.
Inclusion criteria: Inclusion and
Exclusion criteria:

 Subject will be a veteran with El Escorial Lab Supported Probable or more definite diagnosis of ALS.

 Subject will have lost the ability to communicate either verbally or in writing (item 1 or item 4 on the ALS Functional Rating Scale-Revised (ALSFRS-R) score of 0, Appendix A) .

 Subject will be an adult (age >18).

 Subject will be living at home.

 Subject will be living within 100 miles of the participating study site.

 Subject will have corrected visual acuity of at least 20/80.

 Subject will have the ability to read and understand 6th grade English text on a computer screen.

 Subject will be able to indicate willingness and understanding of the consent form (using their existing method of communication).

 Subject will be able to identify one significant other.

 Subject will identify one system operator (person that agrees to be trained and set up the BCI). This person can be the significant other.

 Subject will be able to communicate non-verbally with their significant other, caregiver and system operator, and with study personnel.

 Significant other, caregiver and system operator will be able to indicate willingness and understanding of the consent form, be adults (age> 18) and expect to be with the subject for at least one year.

 Subject, significant other, caregiver and system operator will have life expectancy of at least one year.

 In the opinion of the BCI installation team, the home environment is physically and technologically conducive to BCI operation and use.

 Subject will demonstrate during the screening phase sufficient EEG interaction for the BCI to operate, i.e. classification rate of 70%. Classification rate is defined as the proportion of correct selections made during the daily calibration period of copy spelling. Copy spelling data refers to data collected while the patient attends to and selects specific predefined characters.

 Significant other, caregiver and system operator will demonstrate during the screening phase sufficient skill to manage the daily set-up and routine operations needed for the subject's basic operation of the BCI.


Sanaria PfSPZ Challenge With Pyrimethamine Chemoprophylaxis (PfSPZ-CVac Approach): Phase 1 Trial to Determine Safety and Protective Efficacy of Sanaria PfSPZ Challenge With Concurrent Pyrimethamine Treatment That Inhibits Development of Asexual B...

Summary: Background:~- Malaria is a severe infection caused by a parasite. People can get malaria if a mosquito that carries the parasite bites them. Although malaria does not occur in the United States, many people in Africa, Asia, and South America do get malaria. In some cases, malaria can cause death. In 2013 alone, 584,000 people died due to malaria. Researchers want to find ways to prevent and treat malaria.~Objective:~- To find out if combining live, infectious malaria parasites (known as Sanaria PfSPZ Challenge) and two FDA approved drugs that kill malaria parasites (pyrimethamine [PYR] and chloroquine [CQ]) is safe and can provide people protection against malaria. The Sanaria PfSPZ Challenge has been used in other studies without significant side effects.~Eligibility:~Healthy people ages 18-50 who weigh less than 170 pounds and are not pregnant or breastfeeding~No history of hepatitis B, hepatitis C, or HIV infection~Not currently enrolled in a clinical trial that involves a research drug or vaccine~Have not traveled to an area with high malaria transmission within the last 5 years~Never diagnosed with malaria in the past~Design:~Participants will be in 1 of 4 groups.~Participants will receive a combination of injections and drugs. What combination they will receive will depend on what group they are in. This combination of injections and drugs may include:~Injections of Sanaria PfSPZ Challenge (live, infectious malaria parasites) into a vein~FDA approved antimalarial drug called chloroquine (CQ)~FDA approved antimalarial drug called pyrimethamine (PYR)~FDA approved antimalarial drug called Malarone~The study will last approximately 3-7 months (depending on which group participants are in).~There will be up to 68 study visits for three groups. One group will have up to 27 study visits. During the study visits, participants may have:~Medical history review~Physical exams~Electrocardiogram (ECG): soft electrodes will be placed on the skin. A machine will record the heart s electrical signals to evaluate heart function.~Blood and urine tests~Medication given in the clinic under direct observation~Injection of Sanaria PfSPZ Challenge into a vein~Participants will receive a diary, thermometer, and ruler to record their body temperature and any symptoms.
Inclusion criteria: inclusion criteria:

 All of the following criteria must be fulfilled for a subject to participate in this trial:

 Age greater than or equal to 18 and less than or equal to 50 years.

 In good general health and without clinically significant medical history

 Malaria comprehension exam completed, passed (a score of greater than or equal to 80% or per investigator s discretion) and reviewed prior to enrollment

 Reliable access to the clinical trial center and availability to participate for duration of study

 Females of childbearing potential must be willing to use reliable contraception (as defined below) from 21 days prior to study day -2 to 28 days following last Sanaria .

 Subject to the judgment and discretion of the PI, female participants who meet ANY ONE of the criteria listed immediately below, may not be required to take any additional measures to avoid pregnancy. Such participants will be counseled on risks at the time of consent and at appropriate points (e.g. when pregnancy testing occurs) during the study:

 Females who have had their uterus, and/or BOTH ovaries removed

 Females who have had BOTH fallopian tubes surgically tied or removed

 Females who are above the age of 45 and have spontaneously had no menses at any point during the past 12 or more consecutive months (i.e. have reached menopause)

 Females who, in the conservative and reasonable judgment of the PI (e.g. due to sexual orientation or serious life choice (such as being celibate clergy or transgender), during the entire trial will NOT participate in any potentially reproductive sexual contact

 Females who, in the conservative and reasonable judgment of the PI, are in a monogamous stable relationship with a male who has undergone vasectomy at least 4 months prior or another procedure/medical condition that deems the male sterile

 Subject to the judgment and discretion of the PI, female participants who DO NOT meet ANY of the criteria listed above, will be appropriately counseled on reproductive risks and pregnancy avoidance, and will be required to adhere to the following measures and agree to 2 methods of pregnancy prevention as noted below:

 CATEGORY 1:

 a highly effective hormonal method to prevent pregnancy [e.g. CONSISTENT, CONTINUOUS use of contraceptive pill, patch, ring, implant or injection], and/or

 IUD or equivalent

 IN ADDITION TO

 CATEGORY 2:

 -a barrier method to be used at the time of potentially reproductive sexual activity (e.g. [male/female condom, 'cap,' or diaphragm] plus spermicide).

Exclusion criteria: :

 A subject will be excluded from participating in this trial if any one of the following criteria is fulfilled:

 Currently is breast-feeding (if female).

 Pregnancy as determined by a positive urine or serum human choriogonadotropin (beta-hCG) test at any point during the study (if female).

 Recent travel to a malaria endemic area within 5 years of enrollment

 Planned travel to a malaria endemic area during the study period

 History of confirmed malaria diagnosis on peripheral blood smear or by clinical history in the past 10 years.

 Hemoglobin, WBC, platelets, ALT, and creatinine outside of local lab normal range (subjects may be included at the investigator s discretion for not clinically significant values outside of normal range)

 Abnormal urinalysis as defined by positive urine glucose, protein, and hemoglobin. Subject can be included if investigator determine the abnormality is not clinically significant .

 Anticipated use during the study period, or use within the following periods prior to enrollment:

 Investigational malaria vaccine within the last five years

 Malaria chemoprophylaxis within 6 months

 Chronic systemic immunosuppressive medications (>14 days) within 6 months (e.g.cytotoxic medications, oral/parental corticosteroids >0.5 mg/kg/day prednisone or equivalent). Corticosteroid nasal spray for allergic rhinitis and topical corticosteroids for mild, uncomplicated dermatitis are allowed.

 Blood products or immunoglobulins within 6 months

 Systemic antibiotics with antimalarial effects within 30 days (such as clindamycin, doxycycline)

 Investigational or non-registered product or vaccine within 30 days

 Receipt of a live vaccine within 28 days or a killed vaccine within the 14 days prior to Sanaria PfSPZ Challenge

 Medications known to interact with pyrimethamine, chloroquine, atovaquone, proguanil (during the study period only)

 History of:

 Sickle cell disease, sickle cell trait, or other hemoglobinopathies

 Splenectomy or functional asplenia

 Systemic anaphylaxis

 Any allergic reactions to study drugs

 Documented history of chronic or active neurologic disease (including seizures, uncontrolled migraine headaches)

 Psoriasis or porphyria

 Ocular diseases including retinopathy or visual field defects

 Clinically significant medical condition, physical examination findings, other clinically

 significant abnormal laboratory results, or past medical history that may have clinically significant implications for current health status and participation in the study in the opinion of the Investigator. A clinically significant condition or process includes but is not limited to:

 A process that would affect the immune response, or requires medication that affects the immune response

 Any contraindication to repeated phlebotomy

 A condition or process in which signs or symptoms could be confused with reactions to malaria challenge and/or infection, including dermatologic abnormalities at the site of sporozoite inoculation

 A chronic or subclinical condition which could be exacerbated by administration of any of the PfSPZ-CVac components or malaria infection

 Weight > 77.2 Kg at the time of screening (this will result in a minimum dose of pyrimethamine of approximately 0.7mg/Kg for a 50mg daily dose). (Note not required for Arm 4 CHMI controls)

 History of, or known active cardiac disease including: (1) prior myocardial infarction (heart attack); (2) angina pectoris; (3) congestive heart failure; (4) valvular heart disease; (5) cardiomyopathy; (6) pericarditis; (7) stroke or transient ischemic attack; (8) exertional chest pain or shortness of breath; or ( 9) other heart conditions under the care of a doctor

 Clinically significant ECG findings, as determined by the expert study cardiologist

 Moderate or high risk for coronary heart disease (CHD) based on NHANES I cardiovascular risk assessment

 Acute illness at the time of enrollment

 Infection with HIV, Hepatitis B, Hepatitis C

 Psychiatric condition that precludes compliance with the protocol including but not limited to:

 Psychosis within the past 3 years

 Ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years

 Suspected or known current alcohol or drug abuse as defined by the American Psychiatric Association in the DSM V at the discretion of the PI

 Clinical trial staff and/or Sanaria employees with direct involvement in the conduct of the trial are excluded from participation.

 Participating in other clinical trials involving investigational interventions or off label medication use during the study period (excluding participation in the optional long term follow up visits). Participation in other trials such as observational or imaging studies will be discussed with the investigators.

 Any other finding that, in the judgment of the Investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a subject s ability to give informed consent, or increase the risk of having an adverse outcome from participating in the study

['Chloroquine (CQ)', 'Pyrimethamine (PYR)', 'Sanaria PfSPZ Challenge (NF54)']

Chloroquine (CQ)
Pyrimethamine (PYR)
Sanaria PfSPZ Challenge (NF54)


EBUS Guided Cryo Biopsy of Solitary Pulmonary Nodules

Summary: To proof the feasibility and safety of EBUS guided transbronchial cryo biopsies in peripheral lung lesions
Inclusion criteria: inclusion criteria:

 solitary pulmonary nodule < 4 cm

 no endobronchial lesion

 indication for bronchoscopy

Exclusion criteria: :

 coagulopathy

 pulmonary hypertension

 pregnancy

['Yield of Cryo Biopsy in Lung Cancer', 'Solitary Pulmonary Nodule']

Yield of Cryo Biopsy in Lung Cancer
Solitary Pulmonary Nodule


Integrated Model for Promoting Parenting and Early School Readiness in Pediatrics

Summary: This study tests a comprehensive approach to the promotion of school readiness in low-income families, beginning shortly after the birth of the child, through enhancement of positive parenting practices (and when present, reduction of psychosocial stressors) within the pediatric primary care platform. The investigators do so by integrating two evidence-based interventions: 1) a universal primary prevention strategy (Video Interaction Project [VIP]); and 2) a targeted secondary/tertiary prevention strategy (Family Check-up [FCU]) for families with infants/toddlers identified as having additional risks. VIP provides parents with a developmental specialist who videotapes the parent and child and coaches the parent on effective parenting practices at each pediatric primary care visit. FCU is a home-based, family-centered intervention that utilizes an initial ecologically-focused assessment to promote motivation for parents to change child-rearing behaviors, with follow-up sessions on parenting and factors that compromise parenting quality.~Two primary care settings serving low-income communities in New York City, NY and Pittsburgh, PA will be utilized to test this integrated intervention in hospital-based clinics, providing information about translation across venues where one of the two interventions has been previously used alone.~The investigators plan to test the VIP/FCU model in a randomized trial of 400 families utilizing parent surveys, observational data on parent-child interactions, and direct assessments of children's development, at key points during intervention follow-up. Analyses will address questions of program impact for the integrated program across all families and by key subgroups.~The largest single contribution made by this study is to test whether an integrated primary and secondary/tertiary prevention strategy implemented in pediatric primary care can produce impacts on early school readiness outcomes, including social-emotional, pre-academic, and self-regulation. As such, this study has the potential to provide the scientific and practice communities with information about an innovative approach to promoting school readiness skills among low-income children.
Inclusion criteria: inclusion criteria:

 Baby is getting pediatric care at Bellevue Hospital Center or Pittsburgh Children's Hospital

 Caregiver primary language is English or Spanish

 Family can be contacted (has a working phone)

 Family attended second (follow-up) meeting with study team between when the child was aged 10days and 6weeks old

Exclusion criteria: :

 Birth weight <2500gm

 Gestational age < 37 weeks

 Not singleton birth (twin, triplet, etc.)

 Known or suspected significant genetic abnormality

 Known neurodevelopmental/neuromuscular disorder likely to affect development, movement, e.g., seizure disorder, microcephaly (low head circumference)

 Known sensory defect

 Known significant malformation likely to affect development or likely to require significant therapy

 Meets criteria for Early Intervention at birth

 Not in level I nursery at time of enrollment

 Significant postnatal complication requiring level II or III nursery stay. Examples: sepsis, significant hypoglycemia, seizures

 Mother with known significant impairment that will be barrier to communication and participation (e.g., intellectual disability, schizophrenia)

 Baby not being discharged to mother or father

 Mother and baby will be staying in shelter

 Not planning to stay in NYC/ Pittsburgh for at least 3 years

 Has previously participated in VIP or FCU projects

 Baby experiencing significant medical issues

 Doctor has concerns about baby's hearing or vision

['Video Interaction Project', 'Family Check Up']

Video Interaction Project
Family Check Up

['Personal Satisfaction', 'Infant Behavior', 'Child Behavior', 'Parenting', 'Child Rearing', 'Depression', 'Behavioral Symptoms', 'Social Control, Informal']

Personal Satisfaction
Infant Behavior
Child Behavior
Parenting
Child Rearing
Depression
Behavioral Symptoms
Social Control
Informal


Monoclonal Antibody A1G4 Plus BCG in Treating Patients With Cancer

Summary: RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody A1G4 with BCG may kill more tumor cells.~PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody A1G4 plus BCG in treating patients with cancer.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Histologically confirmed GD2 positive tumors which include:

 High risk neuroblastoma (stage IV, or N-myc amplified, or localized neuroblastoma multiply recurrent)

 Recurrent or metastatic osteosarcoma

 Recurrent or metastatic GD2 positive sarcomas

 If free of disease, patient must be fully recovered from toxic effects or complications of prior treatments (chemotherapy or surgery)

 No greater than 6 months since last chemotherapy or surgery before first injection of A1G4

 PATIENT CHARACTERISTICS:

 Age:

 Any age

 Performance status:

 Not specified

 Life expectancy:

 At least 6 months

 Hematopoietic:

 Absolute neutrophil count greater than 500/mm^3

 Absolute leukocyte count greater than 500/mm^3

 Peripheral T-cell phytohemagglutinin activation (PHA) at least 50% of normal

 Hepatic:

 Not specified

 Renal:

 Not specified

 Cardiovascular:

 No significant heart disease (NYHA class III or IV)

 Other:

 No other serious intercurrent illnesses

 No active infections requiring antibiotics

 No active bleeding

 No primary immunodeficiency

 Not pregnant or nursing

 Adequate contraception required of all fertile patients

 PRIOR CONCURRENT THERAPY:

 Biologic therapy:

 No concurrent antibiotics

 No prior mouse antibodies and detectable human antimouse antibody (HAMA) titer

 Chemotherapy:

 See Disease Characteristics

 At least 6 weeks since nitrosoureas

 At least 4 weeks since other systemic chemotherapy

 Endocrine therapy:

 No concurrent nonsteroidal anti-inflammatory agents

 No concurrent corticosteroid

 Radiotherapy:

 At least 4 weeks since radiotherapy

 No prior radiation therapy to the spleen

 Surgery:

 See Disease Characteristics

 No splenectomy
Exclusion criteria:

['BCG vaccine', 'monoclonal antibody A1G4 anti-idiotype vaccine']


The Influence of the Menstrual Cycle on Lithium and Sertraline Blood Levels

Summary: The aim of this study is to determine whether blood levels of lithium or sertraline are affected by different phases of the menstrual cycle and whether there is an effect on psychiatric symptoms. Subjects are seen for two visits: one visit during the luteal phase and one visit during the follicular phase of the menstrual cycle. On each visit, they will fill out a depression, anxiety and mania rating scale. Also at each visit a 20mL blood sample will be drawn to measure progesterone level and either a lithium or sertraline level, depending on which medication the patient takes. The primary hypothesis in this study is that blood levels of lithium and sertraline will be significantly lower in women during the luteal phase of the menstrual cycle than during the follicular phase. Examination will also be made of whether symptoms will increase in severity during the luteal phase as compared to the follicular phase. The investigators expect a negative linear association between symptom severity and blood level, i.e. expect symptom severity to worsen as blood levels of lithium or sertraline decrease.
Inclusion criteria: inclusion criteria:

 18-40 year old female

 women currently taking Lithium or Sertraline

Exclusion criteria: :

 currently pregnant or breastfeeding

 concurrent use of any form of hormonal birth control, including oral contraceptive pills, Norplant or Depo-provera

 hepatic or renal disease

 irregular menstrual cycles.

['Bipolar Affective Disorders', 'Cyclothymic Disorder', 'Schizoaffective Disorder', 'Major Depressive Disorder', 'Dysthymic Disorder', 'Obsessive-Compulsive Disorder', 'Panic Disorder', 'Posttraumatic Stress Disorder', 'Premenstrual Dysphoric Disorder', 'Social Anxiety Disorder']

Bipolar Affective Disorders
Cyclothymic Disorder
Schizoaffective Disorder
Major Depressive Disorder
Dysthymic Disorder
Obsessive-Compulsive Disorder
Panic Disorder
Posttraumatic Stress Disorder
Premenstrual Dysphoric Disorder
Social Anxiety Disorder


The Renin-Angiotensin System in Essential Hypertension

Summary: Although ACE Inhibitors and Angiotensin Receptor Blockers are effective blood pressure lowering agents, the exact mechanisms by which these agents lower BP are still not fully understood. This study aims to compare the blood pressure and hormonal responses (plasma renin activity and aldosterone) to the ACE inhibitor enalapril and ARB candesartan in individuals with mild essential hypertension.
Inclusion criteria: inclusion criteria:

 Essential Hypertension

 SBP 140-159 mmHg

 DBP 90-99 mmHg

Exclusion criteria: :

 Intolerance of or allergy to ACE Inhibitors or ARBS

 Pregnant or Breastfeeding

 Pre-menopausal women

 Uncontrolled cardiac or renal failure

 Diabetes mellitus

['Enalapril 20 mg bd', 'Candesartan 8 mg bd']


Short Term Hemodynamic Effects of Controlled Slow Breathing With Biofeedback in Patients With Heart Failure

Summary: Heart failure is associated with faster breathing, which has a negative impact on the functioning of the heart. This leads to fatigue, shortness of breath, and exercise intolerance. It has been shown that when slow breathing technique was taught to patients with heart failure, they had a reduction in their sensation of shortness of breath and an improvement in their exercise performance.~The study will compare the short-term effects of controlled slow breathing with biofeedback in normal healthy subjects, acute heart failure, and chronic stable heart failure. The purpose is to see if there is any change in the objective measurements of heart function while breathing at normal rates compared to a controlled slower rate.
Inclusion criteria: inclusion criteria: NORMAL SUBJECTS

 Normal subject without history, signs-symptoms or diagnosis of heart failure

 Age over 18 and willing and able to provide informed consent.

Exclusion criteria: : NORMAL SUBJECTS

 Known allergy to electrode gel and medical adhesive used on electrocardiographic electrodes.

 Pregnancy (as any effect of this device use on pregnancy is not known).

 Patient belonging to a vulnerable population such as institutionalized persons, prisoners and persons with decisional incapacity or dementia.

 Presence of severe aortic regurgitation.

 Second degree Mobitz type II or third degree heart block, unless treated with a cardiac pacemaker.

 Implantation of a left ventricular assists device, hemodynamic monitor, activated minute ventilation pacemaker, or biventricular pacemaker (Cardiac Resynchronization Therapy) with the V-to-V interval set at more than 5 milliseconds offset.

 Implantation of a cardiac resynchronization device within the last 30 days.

 inclusion criteria: CHRONIC AMBULATORY HEART FAILURE

 Patients over the age of 18 and able to give consent

 Ability to understand and willing to sign informed consent

 Diagnosis of Chronic Heart Failure and currently on optimal medical therapy


Ramelteon for the Treatment of Insomnia and Mood Stability in Patients With Euthymic Bipolar Disorder

Summary: The purpose of this study is to determine whether treating sleep difficulties in patients with bipolar disorder also improves their mood stability.
Inclusion criteria: inclusion criteria:

 Provision of written informed consent before initiation of any study-related procedures

 Men and women aged 18 to 65 years.

 A documented clinical diagnosis according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision) meeting criteria 296.4x Bipolar I disorder, most recent episode manic, 296.6x Bipolar I disorder, most recent episode mixed, or 296.5x Bipolar I disorder, most recent episode depressed.

 PSQI total score of >=5.

 MADRS total score of <=12.

 YMRS total score of <= 12

 Female patients of childbearing potential must have a negative urine pregnancy test at enrollment and be willing to use a reliable method of birth control, i.e., double-barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device or tubal ligation, during the study.

 Be able to understand and comply with the requirements of the study, as judged by the investigator.

 Outpatient status at enrollment.

Exclusion criteria: :

 Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status.

 Presence of prohibited medications of antidepressants (including MAOI's) and systemic corticosteroids.

 Patients with a diagnosis of primary insomnia disorders

 Patients with a diagnosis of severe chronic obstructive pulmonary disease

 A clinical finding that is untreated (eg, hypertension, poorly controlled diabetes, angina) or that, in the opinion of the investigator, would be negatively affected by the study medication or that would affect the study medication.

 Patients with active substance abuse diagnoses (except tobacco abuse).

 Known history of intolerance or hypersensitivity to ramelteon or to any other component in the tablet.


Nutritional Status and Barriers to Dietary Intake in Head and Neck Cancer Patients

Summary: The investigators hope to learn more about how side-effects of RT or RTchemo affect food intake and nutrition status.
Inclusion criteria: inclusion criteria:

 18 years or older

 Diagnosed with head and neck cancer including the lip, oral cavity, salivary glands, paranasal sinuses, oropharynx, nasopharynx, hypopharynx, larynx, and thyroid

 All histological types of cancer

 All tumour stages according to American Joint Committee for Cancer (AJCC) Staging

 All forms of RT including standard or investigational and/or concurrent standard or investigational chemotherapy for head and neck cancers

 Alert and mentally competent

 English speaking

Exclusion criteria: :

 Unwilling to participate


Aripiprazole as Augmentation for TRD

Summary: A sizeable minority of patients suffering from major depression do not have their full set of depressive symptoms relieved by a single medication. Often times, a second medication is added to a patient's first antidepressant to obtain a better response in hopes of getting the depressed patient into full remission from symptoms.~A typical psychiatric approach of recent has been to add one of the newer anti-schizophrenia medications to an existing FDA approved antidepressant in order to achieve better serotonin levels in the depressed patient's brain. This optimization of brain serotonin helps to alleviate more depressive symptoms. The newest antipsychotic medication to be FDA approved is Aripiprazole (Abilify). It may be particularly effective as it may safely elevate sertotonin through receptor 1a stimulation, receptor 2a blockade. It may also facilitate low levels of dopamine transmission which is truly novel for this agent when compared to other schizophrenia drugs. Depressed patients also tend to lack dopamine in their brains. This makes Aripiprazole and ideal agent to boost both serotonin and dopamine simultaneously. In theory, this may be an effective way to alleviate more depressive symptoms.~The author suggests to enroll 10 subjects initially in open label fashion to take Aripiprazole plus their current FDA approved antidepressant to see if further elimination of depressive symptoms occurs and to show this pharmacological approach as a tolerable combination of medications. If there are no major safety issues, an amendment to allow 10 additional subjects will be forwarded to provide a better tolerability sample size.
Inclusion criteria: inclusion criteria:

 inclusion criteria: males or females age 18 to 65 years, DSM-IV episode of Major Depression non-psychotic, ≥14 score on the 17-item HRSD, adequate trial with two antidepressants (see definition above of 'adequate trial'), ability to receive and give informed consent, if patients are of child-bearing potential (male or female), use of an effective contraceptive is required for at least one month prior to the screening Visit and documentation of a negative pregnancy (female) test upon entry into the study.

Exclusion criteria: :


Tremelimumab and CP-870,893 in Patients With Metastatic Melanoma

Summary: RATIONALE: Monoclonal antibodies, such as tremelimumab and CD40 agonist monoclonal antibody CP-870,893, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving tremelimumab together with CD 40 agonist monoclonal antibody CP-870, 893 may kill more tumor cells.~PURPOSE: This phase I trial is studying the side effects and best dose of giving tremelimumab together with CD40 agonist monoclonal antibody CP-870,893 in treating patients with metastatic melanoma.
Inclusion criteria: Inclusion

 Patients with metastatic melanoma who have measurable disease

 ECOG PS 0 or 1

 Adequate bone marrow function

 WBC >= 3,000

 Hgb >= 9

 Plt >= 100

 Adequate hepatic function, defined by the following parameters:

 Total bilirubin WNL unless associated with hepatobiliary metastases or Gilbert syndrome, then total bilirubin =< 2 x ULN

 Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN unless associated with hepatic metastases, then ALT and AST =< 5 x ULN

 Signed, written informed consent

 Exclusion

 Previous treatment with any other compound that targets CD40 or CTLA4

 Concurrent treatment with any anticancer agent outside of this protocol

 Prior allogeneic bone marrow transplant

 History of brain metastases, even if previously treated

 History of autoimmune disorder, including type 1 diabetes mellitus, pemphigus vulgaris, systemic mastocytosis, systemic lupus erythromatosis, dermatomyositis/polymyositis, rheumatoid arthritis, systemic sclerosis, Sjorgen's syndrome, vasculitis/arteritis, Behcet's syndrome, autoimmune thyroiditis, multiple sclerosis, or uveitis

 History of chronic inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), celiac disease, or other chronic gastrointestinal conditions associated with diarrhea, or current acute colitis or enterocolitis of any etiology

 History of diverticulitis (even a single episode) or evidence at baseline, including evidence limited to CT scan only. Note diverticulosis is not an exclusion criterion per se.

 History (within the previous year) of stroke or transient ischemic attack, unstable angina, myocardial infarction, congestive heart failure

 History of deep venous thrombosis or migratory thrombophlebitis (Trousseau)

 Hereditary or acquired coagulopathies (e.g., hemophilia, von Willebrand's disease, or cancer-associated DIC)

 Prior allergic reactions attributed to other monoclonal antibodies

 Concurrent or planned concurrent treatment with systemic high dose (immunosuppressive) corticosteroids or treatment with systemic corticosteroids within 4 weeks of baseline

 Treatment on another therapeutic clinical trial within 4 weeks of enrollment in this trial

 Concurrent or planned concurrent treatment with anticoagulants such as Coumadin or heparin, except to maintain patency of in-dwelling catheters

 Ongoing or active infection; treatment with systemic antibiotics or antifungals for ongoing or recurrent infection (topical use of antibiotics or antifungals is allowed)

 Pregnancy or breast-feeding; female patients must be surgically sterile, be postmenopausal, or must agree to use effective contraception during the period of therapy and for 12 months following the last dose of either tremelimumab or CP-870,893; all female patients with reproductive potential must have a negative pregnancy test prior to enrollment

 Other uncontrolled, concurrent illness that would preclude study participation; or, psychiatric illness or social challenges that would entail unreasonable risk or preclude informed consent or compliance with study procedures
Exclusion criteria:

['CD40 agonist monoclonal antibody CP-870,893', 'tremelimumab', 'laboratory biomarker analysis']

['Recurrent Melanoma', 'Stage IV Melanoma']


Incidence, Risk Factors, and Risk Model of Acute Kidney Injury in Pediatric Patients Who Undergoing Surgery for Congenital Heart Disease

Summary: Acute kidney injury (AKI) is a major complication after cardiac surgery and has been reported to be associated with adverse outcome. Previous studies have reported that the incidence of AKI in patients undergoing surgery for congenital heart disease is as high as 42% and AKI increase the patient mortality, intensive care unit stay and hospital stay. Previous studies have reported several risk factors for AKI after congenital heart surgery, however, perioperative variables including anesthesia-related factors have not been evaluated fully. Therefore, the investigators attempt to find out independent risk factors regarding perioperative variables.
Inclusion criteria: inclusion criteria:

 patients who underwent surgery for congenital heart disease between January 2012 and December 2012 in Samsung Medical Center

Exclusion criteria: :

 incomplete data for creatinine, estimated glomerular filtration rate, or urine output required to diagnose acute kidney injury

 patients who expired within 24 hours after surgery

['surgery for congenital heart disease']

['Patients Undergoing Surgery for Congenital Heart Disease']


Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder

Summary: Patients with bipolar disorder suffer from sleep disturbances, even in euthymic phases. Changes in sleep are frequent signs of a new episode of (hypo)mania or depression. Cognitive behavioral therapy for insomnia is an effective treatment for primary insomnia, but has not been introduced to patients with bipolar disorder. The aim is to compare cognitive behavioral therapy added to 'treatment as usual' with just 'treatment as usual'. The investigators hypothesize that cognitive behavioral therapy will improve quality of sleep, stabilize minor mood variations and prevent new mood episodes in euthymic patients with bipolar disorder and insomnia.
Inclusion criteria: inclusion criteria:

 Fulfilling criteria for SCID-1-verified bipolar I or II disorder

 Euthymic, as defined by Montgomery Åsberg Depression Rating Scale (MADRS) not higher than eleven, and Young Mania Rating scale (YMRS) not higher than five.

 Fulfilling DSM-IV criteria for primary insomnia or insomnia related to another mental disorder, as assessed by the Insomnia Interview Schedule (IIS).

Exclusion criteria: :

 Being or having been in a defined affective episode the last month before inclusion

 Hospitalization in the last two months before inclusion

 Working night shifts

 Sleep apnea

 Medical conditions incompatible with participation.

 Inability to cooperate in the 3-week initial phase before randomization.

['Cognitive behavioral therapy for insomnia']


TRACT Study: Evaluation of the Value of Routine Thoraco-abdominal CT in Blunt Trauma Patients

Summary: The aim of this study is to establish the additional effectiveness and costs of routine thoraco-abdominal computed tomography (CT) in blunt trauma patients versus conventional radiological imaging and to determine which clinical parameters predict a high additional value of routine thoraco-abdominal CT.
Inclusion criteria: inclusion criteria:

 Patients with life threatening vital problems: respiratory, circulatory (pulse > 120/min, blood pressure < 100 mmHg, refill > 4 sec, exterior blood loss > 500 ml) or neurologically (Glasgow Coma Score < 14, abnormal pupils) compromised patients.

 Patients with a revised trauma score under 12

 Patients with signs of fractures from at least two long bones

 Patients with clinical signs of flail chest/multiple rib fractures

 Patients with a clinically evident pelvic rim fracture

 Patients with signs of unstable vertebral fractures or signs of neural cord compression

 Patients involved in a high-energy injury mechanism

 Fall from height (> 3 m)

 As declared by prehospital emergency medical services

Exclusion criteria: :

 Patients suffering from a shock Class IIIB/IV

 Patients who need immediate neurosurgical intervention

 Pregnant patients

 Patients referred from other hospitals

 Patients who die at the emergency department

['Abdominal Injuries', 'Thoracic Injuries']


Chest Wall Influence on Respiratory System Mechanics in Morbidly Obese Patients

Summary: The goal of this study is to describe the influence of the chest wall on the respiratory system mechanics in morbidly obese patients and in patients with high intra-abdominal pressure.~The effects of increasing and decreasing positive end-expiratory pressure (PEEP) on chest wall and total respiratory system mechanics, lung volumes and gas exchange will be evaluated, both during controlled and assisted mechanical ventilation.~Patients will be studied, first, during the acute phase of respiratory failure, when requiring intubation and controlled mechanical ventilation. Then, patients will be evaluated again during weaning from the ventilator to assess the influence of PEEP in assisted ventilation prior to extubation.
Inclusion criteria: inclusion criteria:

 18 years or older

 Requiring intubation and mechanical ventilation

 BMI≥40 kg/m2 or IAP≥12 mmHg

Exclusion criteria: :

 Known presence esophageal varices

 Recent esophageal trauma or surgery

 Severe thrombocytopenia (PTL≤10,000/mm3)

 Severe coagulopathy (INR≥2)

 Presence of pneumothorax

 Pregnancy

 Patients with diagnosed moderate to severe ARDS or with poor oxygenation index (PaO2/FiO2 < 200 mmHg)


Allogeneic Virus-Specific Cytotoxic T-Lymphocytes(CTL), Persistent/Recurrent Viral Infection Post-HSCT (EAP CHALLAH)

Summary: Subjects have a type of blood cell cancer, other blood disease or a genetic disease for which they received a stem cell transplant. After transplant while the immune system grows back the subjects have an infection with one or more of three viruses - Epstein Barr virus (EBV), cytomegalovirus (CMV) or adenovirus - that has persisted or come back despite standard therapy.~Adenovirus is a virus that causes symptoms of a common cold normally but can cause serious life-threatening infections in patients who have weak immune systems. It usually affects the lungs and can cause a very serious pneumonia, but it can also affect the gut, the liver, the pancreas and the eyes.~CMV is a virus that can also cause serious infections in patients with suppressed immune systems. It usually affects the lungs and can cause a very serious pneumonia, but it can also affect the intestinal tract, the liver and the eyes. Approximately 2/3 of normal people harbor this virus in their body. In healthy people CMV rarely causes any problems because the immune system can keep it under control. If the subject and/or the subject's donor are positive for CMV, s/he is at risk of developing CMV disease while his/her immune system is weak post transplant.~EBV is the virus that causes glandular fever or kissing disease. It is also normally controlled by a healthy immune system, but when the immune system is weak, it can cause fevers, enlarged lymph nodes and sometimes develop into a type of cancer called lymphoma.~This treatment with specially trained T cells (called CTLs) has had activity against these viruses when the cells are made from the transplant donor. However, as it takes 2-3 months to make the cells, that approach is not practical when the subject already has an infection. We want to find out if we can use CTLs which have already been made from another donor that match the subject and his/her donor as closely as possible and if the CTLs will last in the body and have activity against these viruses.~In a recent study these cells were given to 50 patients with viral infections post transplant and over 70% had a complete or partial response. The purpose of this study is to make CTL lines leftover from that previous study available to patients with viral infections that have not responded to standard treatments.~These virus-specific CTLs are an investigational product not approved by the FDA.
Inclusion criteria: inclusion criteria:

 Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow, peripheral blood stem cells or single or double umbilical cord blood.

 CMV, adenovirus or EBV infection persistent despite standard therapy

 For CMV infection

 Patients with CMV disease: defined as the demonstration of CMV by biopsy specimen from visceral sites (by culture or histology) or the detection of CMV by culture or direct fluorescent antibody stain in bronchoalveolar lavage fluid in the presence of new or changing pulmonary infiltrates OR

 Failure of antiviral therapy: defined as the continued presence of pp65 antigenemia (>1+ cell/100,000 cells) or DNAemia (as defined by reference lab performing PCR assay but usually >400 copies/ml) after at least 7 days of antiviral therapy OR

 Relapse after antiviral therapy defined as recurrence of either pp65 antigenemia or DNAemia after at least 2 weeks of antiviral therapy

 For CMV infection, standard therapy is defined as 7 days therapy with Ganciclovir, Foscarnet or Cidofovir for patients with disease or recurrence after 14 days therapy

 For EBV infection

 EBV infection is defined as:

 Biopsy proven lymphoma with EBV genomes detected in tumor cells by immunocytochemistry or in situ PCR OR

 Or clinical or imaging findings consistent with EBV lymphoma and elevated EBV viral load in peripheral blood.

 For EBV infection, standard therapy is defined as rituximab given at 375mg/m2 in patients for 1-4 doses with a CD20+ve tumor

 Failure is defined as

 There was an increase or less than 50% response at sites of disease for EBV lymphoma OR

 There was a rise or a fall of less than 50% in EBV viral load in peripheral blood or any site of disease

 For adenovirus infection or disease

 Adenovirus infection is defined as the presence of adenoviral positivity as detected by PCR, DAA or culture from ONE site such as stool or blood or urine or nasopharynx OR

 Adenovirus disease will be defined as the presence of adenoviral positivity as detected by culture from two or more sites such as stool or blood or urine or nasopharynx

 Standard therapy is defined as 7 days therapy with Cidofovir (if renal function permits this agent to be given).

 Failure is defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease as measured by PCR or any other quantitative assay).

 Patients with multiple CMV, EBV or Adenovirus infections are eligible given that each infection is persistent despite standard therapy as defined above. Patients with multiple infections with one persistent infection and one controlled infection are eligible to enroll.

 Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg/kg/day prednisone.

 Written informed consent and/or signed assent line from patient, parent or guardian.

Exclusion criteria: :

 Received ATG, or Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of screening for enrollment.

 Uncontrolled infections. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment.

 Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.

 Received donor lymphocyte infusion (DLI) within 28 days.

 Active acute GVHD grades II-IV.

 Active and uncontrolled relapse of malignancy

 Pregnant or lactating in female patients, if applicable (childbearing potential who have received a reduced intensity conditioning regimen).

['EBV Infection', 'CMV Infection', 'Adenoviral Infection']

EBV Infection
CMV Infection
Adenoviral Infection


Neurobehavioral Consequences of Sleep Apnea in Children

Summary: To identify physiological and clinical measures of obstructive sleep-disordered breathing that are associated with increased morbidity in children.
Inclusion criteria: No eligibility criteria
Exclusion criteria:

['Lung Diseases', 'Sleep Apnea Syndromes']


The Effect of Perioperative Medications on the Outcomes of Patients Undergoing Cardiac Surgery

Summary: This study will be a retrospective study. The patient data from the electronic medical records and existing database will be collected and analyzed. Primary endpoints will be postoperative mortality (within 30 days) and overall complications and length of hospital stay. The secondary endpoints will be myocardial infarction, cardiac death, CHF, arrhythmia, ischemia, stroke, neurological complications, length of ICU stay, re-admission rate, infections, pulmonary complications, length of intubation time, length of ventilation time, and acute renal failure.
Inclusion criteria: inclusion criteria:

 All cardiac surgical patients

Exclusion criteria: :

 Non cardiac surgery


Characteristics of Blood- Brain Barrier Permeability in Neurological Patients

Summary: The main goal of the present study is to challenge the hypothesis that blood- brain barrier disruption following brain injury increases the risk for long-term disability, development of brain dysfunction, epileptic seizures and neuroanatomical alterations.
Inclusion criteria: inclusion criteria:

 One week following:

 Traumatic Brain Injury

 Cerebro- Vascular Accident

 Subsequent brain CT showed cerebral cortex injury.

Exclusion criteria: :

 A known ailment of the central nervous system.

 Use of medications or illicit drugs that significantly affect the central nervous system.

 tourist or temporary residents not available for follow-up.

 For MRI examinations: heart pacemaker, metal implants, or metal shrapnel.

['Traumatic Brain Injury', 'Cerebral Infarction', 'Cerebral Hemorrhage']

Traumatic Brain Injury
Cerebral Infarction
Cerebral Hemorrhage


Uterine Leiomyoma Treatment With Radiofrequency Ablation

Summary: The ULTRA study is a single-arm trial of 100 premenopausal women with symptomatic uterine fibroids who undergo treatment with the Acessa device. The Acessa device is a new FDA approved minimally invasive treatment for uterine fibroids that uses radiofrequency energy to destroy fibroid tissue. The fibroids then shrink and symptoms are significantly improved. The radiofrequency energy is delivered to the fibroids during an outpatient surgical procedure. There is minimal blood loss and pain and women return to the usual activities 5-9 days after the Acessa procedure.~The investigators will evaluate changes in fibroid-related symptoms from before the Acessa treatment to 3, 6, 12, 18, 24, 30, and 36 months after Acessa treatment. The investigators will also assess operative outcomes including procedure duration, complications, blood loss, post-operative pain, and the time to return to usual activities. The investigators will determine long-term efficacy of Acessa by evaluating the rate of re-treatment for symptomatic fibroids after the Acessa procedure.~Study participants will be recruited at 5 sites within the UC Fibroid Network: UC Davis, UC Irvine, UC Los Angeles, UC San Diego, and UC San Francisco. UC San Francisco will serve as the Coordinating Center for the trial with oversight of all scientific and administrative aspects of the study. All study data will be stored securely in a HIPAA compliant, secure database monitored by the UC San Francisco Coordinating Center. A data safety and monitoring board will oversee participant safety and protection.
Inclusion criteria: inclusion criteria

 Premenopausal (at least 1 menstrual period in last 3 months)

 Age >21years

 Fibroids are associated with heavy bleeding, pelvic pressure or discomfort, urinary or bowel symptoms, or dyspareunia

 Desires surgical management of fibroids

 Uterus ≤16 weeks in size

 All fibroids ≤ 10cm in maximum diameter by ultrasound or MRI assessment within the last year.

 Total number of fibroids ≤6 by ultrasound or MRI assessment within the last year. (For this study Fibroids will be leiomyomas > 2cm)

 Had a Pap smear within the last 3 years with appropriate follow-up and treatment for cellular abnormalities

 Endometrial biopsy indicates no hyperplasia or cancer (biopsy only required if age >45 years and has anovulatory heavy bleeding)

 Able to tolerate laparoscopic surgery

 Able to give informed consent

Exclusion criteria:

 Planned treatment for infertility

 Pedunculated fibroid with thin stalk (total stalk length is <25% maximum diameter of fibroid)

 Intracavitary (FIGO Type 0) fibroid

 Symptomatic fibroids are only FIGO Type 1 (submucosal with ≥ 50% intracavitary)

 Planned concomitant surgical procedure in addition to treatment of uterine fibroids

 Use of Essure or any other metallic, implantable device within pelvis

 Pregnancy

 Pelvic infection with the last 3 months

 History of pelvic malignancy and/or pelvic radiation

 Known or high suspicion for dense pelvic adhesions

 Fibroids treated by myomectomy, uterine artery embolism, radio-frequency ablation, MRI Guided focused ultrasound, or cryomyolysis within the last 3 months


Volitional Swallowing in Stroke Patients With Chronic Dysphagia

Summary: This study will compare several techniques designed to improve the ability to swallow in stroke patients with chronic dysphagia (difficulty swallowing).~Healthy volunteers 20 to 60 years of age and people 20 to 90 years of age who have had a stroke resulting in swallowing problems may be eligible for this study. Volunteers are screened with a medical history, physical examination, and urine test for women to rule out pregnancy. Stroke patients are screened additionally with a chest x-ray, physical examination, cognitive screening, swallowing questionnaires, nasoendoscopy (examination of the nasal passages in the back of the throat using a lighted telescopic instrument) and FEESST (passage of a thin, flexible telescope through the nose to the voice box), videofluoroscopy (x-ray of the head and neck during swallowing) and button press training (learning how to press a button on a table in coordination with swallowing).~All participants undergo the following procedures:~Transcranial magnetic stimulation (TMS): A metal coil is placed on the head and sends a pulse of energy to the brain through the scalp. The muscle response to the pulse is recorded from the muscles in the throat that are associated with swallowing.~Electromyography: A needle is used to insert tiny wires in specific muscles of the throat to record the muscle response to the TMS pulses.~Magnetic resonance imaging (MRI): During brain MRI scanning, subjects lie quietly and images of the brain are taken.~In addition to the above tests, stroke patients undergo the following:~Water test: The subject swallows a small amount of water and the number of times required to clear the throat or cough is counted. This test is repeated five times.~Experimental training. Subjects have a total of 12 60-minute training sessions, one session a day for up to 5 sessions a week.~Button press training: The subject swallows small amounts of water. A device placed on the throat senses when swallowing occurs. The subject learns how to coordinate pressing a button on a table in coordination with swallowing.~Vibrotactile stimulator training: A device that uses a buzzing vibration is placed on the throat at times during the swallowing training.~Transcranial direct current stimulation (tDCS): Wires attached to sponge electrodes are placed on the scalp and over the eye. Small electric currents are delivered to areas of the brain involved with swallowing. This is done at times during the swallowing training.~Participants may receive one of several combinations of training approaches; all receive the volitional (button-press) training. Within 5 days of completing training, subjects repeat the tests. TMS, MRI, MEG and x-ray study of swallowing function are also repeated to see if any changes have occurred in the brain or in the ability to swallow after training. Patients are contacted by telephone and in writing 3 and 6 months after training for follow-up on their swallowing status and oral intake.
Inclusion criteria: inclusion criteria FOR PATIENTS WITH CHRONIC PHARYNGEAL DYSPHAGIA DUE TO BRAIN INJURY

 Inclusive ages of 20 to 90

 History of brain injury. No specific localization of brain injury or brain injuyr type will be required for inclusion.

 Evidence of pharyngeal phase dysphagia following the brain injury that places the patient at risk for aspiration.

 Risk for aspiration or frank aspiration will be based on the medical history and evidence from a videofluoroscopic swallowing study. Absence of aspiration is not cause for exclusion if the risk for aspiration is deemed present due to impaired pharyngeal phase of swallowing as judged by an expert experienced in the evaluation of dysphagia. The patient may demonstrate evidence of aspiration or the risk for aspiration on any consistency, perhaps secondary to pharyngeal retention. Aspiration is defined as passage of food, liquid, or secretions into the trachea below the level of the vocal folds. If the patient does not demonstrate either aspiration or a risk for aspiration in previous assessment or during preliminary studies, they will be excluded from participation.

 Impaired pharyngeal phase of swallowing may be evidenced by pharyngeal delay, reduced hyolaryngeal elevation, reduced laryngeal closure, and reduced pharyngeal clearance of the bolus. Signs of pharyngeal delay include hesitation of the material in the vallecula at times with spill over into the pyriform sinuses. Normally the pharyngeal phase of swallowing should be less than 1 second from onset until the passage of the bolus into the posterior pharynx. Delay will be defined as the time from the entry of the head of the bolus into the oropharynx at the posterior tongue and the lower posterior edge of the angle of the mandible, to the beginning of elevation of the hyoid bone and larynx. Reduced hyolaryngeal elevation will be identified when the larynx is not protected and remains open to the bolus during a swallow on videoendoscopy. Reduced pharyngeal clearance will be seen during videoendoscopy when the bolus remains in the vallecula and/or pyriform sinuses.

 Chronic dysphagia can occur as a result of stroke or other brain injury. Lesions in either hemisphere and/or the brain stem may cause dysphagia and aspiration.

 Duration of 4 months or greater post-onset of brain injury and dysphagia

 Participants may have other health problems such as diabetes mellitus, arteriosclerotic coronary vascular disease and a history of smoking. These will not be cause for automatic exclusion, but will be examined on an individual basis by the otolaryngologist in determining the potential risk and benefit to the individual participant.

 Prior history of tracheostomy or current tracheostomy is not a cause for exclusion. The otolaryngologist will determine if an individual with tracheostomy is an appropriate candidate for the study.

 Patients should be on a restricted diet level. This may include a diet level restriction such as pureed or chopped solids, restrictions to certain solid food items, or thickened liquids. Patients may be receiving alternate means of nutrition and hydration (PEG, PEJ, PPN/TPN) for some or all of their nutritional intake, or they may be receiving all of their nutritional intake orally.

 Adequate cognitive skills as demonstrated by a Mini-Mental State Examination (MMSE) score greater than or equal to 23

 Stable medical status.

 To determine if a patient has stable vital signs prior to admission, the patient will be asked to provide a letter from their physician stating that the patient is medically stable and may participate in the study.

Exclusion criteria:  FOR PATIENTS WITH CHRONIC PHARYNGEAL DYSPHAGIA DUE TO BRAIN INJURY

 History of epileptic seizure

 If subject is participating in TMS, history of cardiac rhythm condition (including heart murmur or cardiac arrhythmia) or a cardiac pacemaker in place

 History of progressive neurodegenerative disorders, such as progressive dementia, Parkinson's Disease, multiple sclerosis, and amyotrophic lateral sclerosis

 History of malignant brain tumor

 Severe oral phase swallowing deficits that prevent bolus retention in the oral cavity

 Esophageal motility disorder preventing food or liquid from adequately moving through the esophagus into the stomach

 Pregnant women will be excluded from participation because the study involves radiation exposure and MRI scanning (for anatomical co-registration purposes).

 Current psychiatric disorder other than depression, as evidenced by being under the care of a psychiatrist, or on medications for treatment of a psychiatric disorder. Examples of psychiatric disorders to be excluded are: somatoform disorders, conversion disorders, schizophrenia or bipolar disorder.

 Presence of metal in the body (prostheses, electrodes, shrapnel, aneurism clips, other medical hardware) and presence of certain tattoos with ferromagnetic metal or permanent makeup will exclude subjects due to the exposure to high magnetic force through MRI/fMRI/TMS procedures due to the exposure to high magnetic force in both procedures. Subjects who were metal workers as a previous occupation will also be excluded only from MRI/TMS procedures due to the possibility of unknown/undetected metal in their body. Subjects who have MRI-compatible metal implants (e.g. titanium implants) may still be considered as candidates for MRI study, pending review and discussion of documentation regarding the device material and safety of the device in a 3T scanner by the Principal Investigator, LSS staff physician, and an MRI technologist.

 No person with the presence of broken skin in the area of the tDCS or TMS stimulating electrodes will participate in tDCS or TMS.

 Inability to coordinate button or switch press with swallow (as determined during screening) will exclude patients from participating

 Presence of severe pulmonary disease, defined in pulmonary testing by a Forced Expiratory Volume in 1 sec (FEV1) less than 50% of the predicted value based on sex, age and height may exclude patients from participating at the discretion of the Internal Medicine Service.

 inclusion criteria FOR HEALTHY VOLUNTEERS (FOR PILOT STUDY)

 Inclusive ages of 18 to 75

 The healthy volunteers will be without cardiac, neurological, psychiatric, speech or swallowing problems as determined by medical history and examination by a physician


Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the US

Summary: This study used 3 different formulations of tetravalent CYD dengue vaccine.~The primary objective of the study was to evaluate the neutralizing antibody response after 2 doses of two different formulations of tetravalent dengue vaccine administered at Month 0 and Month 6.~The secondary objectives were:~To evaluate the safety of the 3 formulations of tetravalent CYD dengue vaccine.~To describe the neutralizing antibody responses to each of the 3 vaccine formulations.~To describe vaccine viremia after the first and second dose of each of the 3 vaccine formulations in a subset of participants.
Inclusion criteria: inclusion criteria:

 Healthy, as determined by medical history, clinical examination, and biological safety parameters.

 Aged 18 to 45 years on the day of inclusion.

 Provision of informed consent signed by the participant or another legally acceptable representative.

 For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, and until at least 4 weeks after the last study vaccination.

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

Exclusion criteria: :

 Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.

 For a woman of child-bearing potential, known or suspected pregnancy or positive serum/urine pregnancy test.

 Breast-feeding woman.

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

 Planned participation in another clinical trial during the present trial period.

 Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term (at least 2 weeks within the previous 3 months) systemic corticosteroids therapy (at a dose of at least 10 mg). Topical steroids were allowed.

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

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

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

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

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

 Planned receipt of any vaccine in the 4 weeks following each of the trial vaccinations.

 Human Immunodeficiency Virus (HIV), hepatitis B surface antigen, or hepatitis C virus seropositivity in blood sample taken at Screening.

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

 Clinically significant laboratory test abnormalities (as determined by the investigator) in blood sample taken at Screening.

 Previous residence in, travel or planned travel of more than 2 weeks during the study period to areas with high dengue infection endemicity.

 Reported history of flavivirus infection as reported by the participant.

 Previous vaccination against flavivirus diseases (including Japanese encephalitis, tick-borne encephalitis, and yellow fever).

 Flavivirus vaccination planned during the trial period.

['Tetravalent CYD Dengue Vaccine , 5555 formulation', 'Tetravalent CYD Dengue Vaccine , 5553 formulation', 'Tetravalent CYD Dengue Vaccine, 4444 formulation']

Tetravalent CYD Dengue Vaccine
5555 formulation
Tetravalent CYD Dengue Vaccine
5553 formulation
Tetravalent CYD Dengue Vaccine
4444 formulation

['Dengue Fever', 'Dengue Hemorrhagic Fever', 'Dengue Virus']

Dengue Fever
Dengue Hemorrhagic Fever
Dengue Virus


Examining Written Disclosure as a Treatment for Post-Traumatic Stress Disorder

Summary: This study will test the effectiveness of writing about a traumatic incident to treat post-traumatic stress disorder in people who have been in car accidents.
Inclusion criteria: inclusion criteria:

 Primary diagnosis of post-traumatic stress disorder

 Involved in motor vehicle accident that occurred at least 3 months ago

Exclusion criteria: :

 Current diagnosis of mania, hypomania, bipolar depression, psychotic disorder, substance abuse disorder, or severe depression

 History of psychosis

 Active suicidality or history of two or more suicide gestures or attempts in the past year

 Significant cognitive impairment

 Current participation in a psychosocial treatment, such as individual or group therapy led by a clinician


Strategy for Early Treatment of Exacerbations in COPD: Standing Prescriptions of Advair With a Written Action Plan in the Event of an Exacerbation

Summary: The purpose of this pilot study is to determine whether early treatment of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) with a combination therapy, Salmeterol + Fluticasone Propionate (SFP - Advair) will reduce the use of prednisone, known as the conventional treatment.~Primary objective: To determine whether early treatment with combination therapy (SFP) can reduce the use of prednisone (the conventional treatment) in the event of an AECOPD.~Secondary objectives:~To evaluate the feasibility of this treatment approach and to provide pilot data (needed for a larger multi-centre clinical trial;~To evaluate the feasibility and need of assessment during and after exacerbation onset, health-related quality of life and physical activity;~To evaluate the safety of this approach; this is in terms of the delay in starting prednisone and an unfavourable outcome (ER visits and/or hospitalization).
Inclusion criteria: inclusion criteria:

 Diagnosis of stable COPD;

 40 years or older;

 Smoking history of at least 10 pack-years;

 Forced Expiratory Volume in one second (FEV1) ≤ 70 % of predicted value and FEV1 / Forced Vital Capacity (FVC) < 0.70;

 Dyspnea ≥ 2 on the Medical Research Council (MRC) scale;

 At least 2 exacerbations requiring prednisone treatment in the past 3 years;

 Using a written action plan and having demonstrated adequate use of the self-administered antibiotic & prednisone (adequate use defined as prednisone started by the patient within 72 hours of symptom worsening and patient called the case-manager as recommended for following the response);

 Already on Advair BID (twice a day) as a maintenance therapy or able to switch over to Advair if already taking another combination medication (Symbicort) as maintenance therapy for COPD.

Exclusion criteria: :

 History of asthma or allergic rhinitis before the age of 40;

 Regular use of oxygen, oral corticosteroids, antibiotics;

 Unstable or life threatening co-morbid condition;

 Medical conditions or taking medications known to affect tremor and/or heart rate (HR).

 Pre-existing medical conditions or on concomitant medications contraindicated with salmeterol or fluticasone propionate (e.g. monoamine oxidase inhibitors and tricyclic antidepressants, beta-adrenergic receptor blocking agents, non potassium-sparing diuretics, inhibitors of cytochrome P450 (ritonavir, ketoconazole));

 On theophyllines.

 Colonized with pseudomonas aeruginosa.

['Double dose of Salmeterol + Fluticasone Propionate', 'Self-management education on the use of a self-administered prescription for exacerbation.', 'Self-administered prescription']

['COPD', 'Chronic Obstructive Pulmonary Disease']

COPD
Chronic Obstructive Pulmonary Disease


Docetaxel, Oxaliplatin, Capecitabine, Bevacizumab and Trastuzumab in Patients With Locally Advanced or Metastatic Gastric Cancer

Summary: Background: It is estimated that in the Netherlands each year approximately 900 patients with gastric cancer or adenocarcinoma of the gastro-oesophageal junction are candidates for chemotherapy. Randomized studies comparing chemotherapy versus best supportive care have shown that survival and quality of life are prolonged with chemotherapy. However, no chemotherapy regimen is clearly superior with regard to prolongation of survival. Therefore, tolerability of treatment and ease of administration (outpatient compared to inpatient) are important considerations for the development of novel treatment schedules. Study design: This is an open-label, multicentre, phase II trial designed to evaluate the efficacy and safety of bevacizumab in combination with docetaxel, oxaliplatin and capecitabine chemotherapy (B-DOC) as first-line therapy in patients with inoperable locally advanced or recurrent and/or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction. In case of HER2 positive inoperable locally advanced or recurrent and/or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction trastuzumab is added to this regimen (B-DOCT).~Study Endpoints:~Primary endpoint Progression free survival defined as the time measured from B-DOCT study, Protocol version 3.0 dated January 18, 2011 Page 5 / 60 the day of registration to first progression or death. Secondary endpoints Toxicity Overall survival, defined as the time from registration to death Response rate defined as the percentage of partial and complete responses Duration of response defined as time from response to first progression Translational research on pharmacogenomic and biological factors that may predict treatment response.
Inclusion criteria: inclusion criteria:

 Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable locally advanced or recurrent and/or metastatic disease not amenable to curative therapy.

 Measurable disease, according to the Response Evaluation Criteria in Solid Tumours (RECIST), assessed using imaging techniques (CT or MRI)

 ECOG Performance status 0, 1 or 2 (see Appendix 2)

 Life expectancy of at least 3 months

 Male or female age ≥ 18 years.

 Signed informed consent.

 Assessment of HER2 status (primary tumour or metastasis) by the central laboratory prior to initiation of study treatment (see section 9.1)

 Able to swallow and retain oral medication.

 LVEF ≥ 50% assessed by multigated radionucleotide angiography (MUGA) or cardiac ultrasound.

Exclusion criteria: :

 Any of the following will exclude the patient from the study:

 Previous chemotherapy for advanced/metastatic disease (prior peri-operative chemotherapy is allowed if at least 6 months has elapsed between completion of this therapy and enrolment into the study).

 Previous radiotherapy on the abdomen.

 Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.

 Patients with active (significant or uncontrolled) gastrointestinal bleeding.

 Residual relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g. neurological toxicity ≥ grade 2 NCI-CTCAE.

 Creatinin clearance <50 mL/min.

 Neutrophil count <1.5 × 109/L, or platelet count <100 × 109/L.

 Serum bilirubin >1.5 × upper limit of normal (ULN); or, AST or ALT >2.5 × ULN (or >5 × ULN in patients with liver metastases); or, alkaline phosphatase >2.5 × ULN (or >5 × ULN in patients with liver metastases, or >10 × ULN in patients with bone but no liver metastases); or, albumin <25 g/L.

 Known dihydropyrimidine dehydrogenase (DPD) deficiency.

 History of documented congestive heart failure; angina pectoris requiring medication; evidence of transmural myocardial infarction on ECG; poorly controlled hypertension (systolic BP >180 mmHg or diastolic BP >100 mmHg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias.

 Patients with dyspnoea at rest due to complications of advanced malignancy or other disease, or who require supportive oxygen therapy.

 Patients receiving chronic or high dose corticosteroid therapy. (Inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed).

 Major surgery within 4 weeks of start of study treatment; serious or not healing wound.

 Known hypersensitivity to any of the study drugs, Chinese hamster ovary cell products or other murine or human recombinant antibodies.

 History or clinical evidence of brain metastases.

 Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.

 Positive serum pregnancy test in women of childbearing potential.

 Subjects with reproductive potential not willing to use an effective method of contraception.

 Any investigational drug treatment within 4 weeks of start of study treatment.

 Radiotherapy within 4 weeks of start of study treatment (2 week interval allowed if palliative radiotherapy given to bone metastastic site peripherally and patient recovered from any acute toxicity)

 Arterial thrombosis; cerebrovascular accident within 6 months prior to study enrolment.

 Therapeutic use of oral coumarin-derived or LMWH anticoagulants or NSAIDs.

 Continuous use of immunosuppressive agents (for the use of corticosteroids see also #12).

['Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab', 'Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab, Trastuzumab']

Docetaxel Oxaliplatin Capecitabin Bevacizumab Docetaxel Oxaliplatin Capecitabin Bevacizumab Trastuzumab

['Metastatic Gastric Cancer', 'Adenocarcinoma of the Gastro-oesophageal Junction']