Lapdap and Coartemether for Uncomplicated Malaria

Summary: Lapdap (chlorproguanil-dapsone) is an affordable and effective drug, but patients with glucose-6-phosphate dehydrogenase (G6PD) A- deficiency are more susceptible to the haemolytic effects of the dapsone component of Lapdap; therefore there is a need to evaluate the extent to which the risks associated with the use of the drug in settings without G6PD screening might outweigh the benefits to malaria treatment. The investigators will evaluate, in operational settings, the safety and effectiveness of Lapdap and coartemether (lumefantrine-artemether) for treatment of uncomplicated malaria in patients 6 months to 10 years of age.
Inclusion criteria: inclusion criteria:

 presentation at health centre with febrile illness

 monoinfection with P falciparum

 parasitaemia >=500/microlitre

 fever or history of fever

Exclusion criteria: :

 signs of severe or complicated malaria (persistent vomiting with or without dehydration, history of convulsion during the present illness, inability to sit or stand, parasitaemia >200,000/ul)

 severe malnutrition

 clinically evident concomitant disease

 PCV <20%

 history of allergy to the study medications

 residence outside the study area and hence difficult to follow up

['Chlorproguanil-dapsone (Lapdap)', 'Lumefantrine-artemether (Coartemether )']

Chlorproguanil-dapsone (Lapdap)
Lumefantrine-artemether (Coartemether )


The Contribution of Lp-PLA2 Level to the Presence of Coronary Plaques in Patients With Non Alcoholic Fatty Liver Disease

Summary: The most common cause of death in patients with NAFLD(Nonalcoholic Fatty Liver Disease) is CAD(Coronary Artery Disease). NAFLD patients have 65% more mortality than general population. The aim of the investigators study is to diagnose early coronary artery disease in NAFLD patient by measuring of PLA2. The investigators expect that PLA2 will higher in patients with patients with combination of CAD, unstable plaque and NAFLD.
Inclusion criteria: inclusion criteria:

 Patients at intermediate risk for significant CAD was admitted to the hospital with the diagnosis of chest pain or undergoing elective CT coronarography due to suspection of coronary artery disease.

 Male and female 18years or older.

 Able to provide written informed consent.

 Intermediate Risk patients for having significant CAD is deﬁned as:

 chest pain or dyspnea in the presence of negative stress tests;

 the absence of chest pain but positive stress tests;

 the absence of chest pain and of positive stress tests but intermittent arrhythmias

Exclusion criteria: :

 Acute coronary syndrome presentation:

 ST segment deviation on ECG and/or

 Cardiac troponin elevation.

 Chest pain in combination with positive tests for myocardial ischemia

 Hemodynamic instability on presentation.

 Inability to write inform consent.

 Age <18 years.

 Participation in an investigational study within the previous 30days.

['Nonalcoholic Fatty Liver Disease', 'Coronary Artery Disease']

Nonalcoholic Fatty Liver Disease
Coronary Artery Disease


Two Contrasting Interventions for Sleep Management

Summary: This study will determine whether Mind-Body Bridging (MBB), a mindfulness training program is more effective than a common sleep medication, Zolpidem, in treating insomnia. It will also investigate whether MBB is additionally beneficial for co-morbid conditions such as stress, PTSD, depression, etc, compared with that of Zolpidem.
Inclusion criteria: inclusion criteria:

 primary insomnia

 secondary insomnia

 requiring sleep medication (Zolpidem) for a three-week trial.

 active duty military service member stationed at Fort Carson.

Exclusion criteria: :

 secondary insomnia to a likely medical condition, such as sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, and other sleep disorders, which are not appropriately treatable with sleep medication.

 treated for sleep problems using sleep medications which include Lunesta, Ambien, Ambien Controlled Release (CR), Seroquel, Trazodone or Remeron

 major psychopathology (i.e., schizophrenia)

 severe depression within the past 90 days

 suicidal ideation within the past 90 days

 psychiatrically hospitalized within the past 90 days

 uncontrolled hypertension or diabetes

 pregnancy

 previous use of Zolpidem proved to be ineffective or to cause other unwanted side effects

 actively abusing controlled substances

 enrolled in another study

['Primary Insomnia', 'Secondary Insomnia']


A Clinical Trial of Pronation Versus Supination Maneuvers for the Reduction of the Pulled Elbow

Summary: Nursemaid elbow or pulled elbow is a condition commonly seen in the emergency department. It is the sudden pull of the radial head (a bone in the elbow) in toddlers. Usually occur when a parent tries to pull the child by the arm and a clic or clunk is felt with immediate pain and unwilling to move the arm. It is not a dangerous condition although it is distressing for kids and their parents/caretakers.
Inclusion criteria: inclusion criteria:

 Pulled elbow suspected in any child presenting one of the following:

 History of an adult or bigger person that had pulled the child's elbow non-intentionally

 Presence of intense pain at the arrival at the emergency department and unwilling to move the arm.

Exclusion criteria: :

 Any suspect of injury that could be intentional (child abuse)

 Any suspicion child of suffering a possible fracture (the mechanism of the injury was not from pulling the child's arm, the arm presents obvious deformity, ecchymoses, edema, etc.)

 The mechanism was from multiple trauma

 Any chronic disease affecting the adequate bone mineralization (vitamin D deficiency, osteogenesis, etc.)


A Phase I/II Trial of Stereotactic Body Radiation Therapy

Summary: The purpose of this study is to use SBRT in patients with early stage lung cancer and find out what effects (good and bad) SBRT has on their cancer. This research is being done because SBRT has not been used very often in patients with early stage lung cancer or in patients with other serious health problems. In addition, this study also will gather information about patient's health and hospitalization history. This information will be used to find out if there are any factors that can help predict recovery or outcome of patients with lung cancer.
Inclusion criteria: ELIGIBILITY:

 inclusion criteria

 Histologically confirmed non-small cell cancer by biopsy or cytology. Squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchioalveolar carcinoma, or non-small cell carcinoma (not otherwise specified) are allowed.

 Staging studies must identify patient as AJCC Stage I or II based on only 1 of following combinations of TNM staging:

 T1, N0, M0

 T2 (<=7cm), N0, M0

 T3 (<=7cm), N0, M0

 Primary tumor must be arising in one of the following central chest locations:

 Within or touching the zone of the proximal bronchial tree (a volume 2cm in all directions around the proximal bronchial tree [carina, R & L main bronchi, R & L upper lobe bronchi, intermedius bronchus, R middle lobe bronchus, lingular bronchus, R & L lower lobe bronchi])

 Adjacent to (within 5 mm) or invading the mediastinal pleura

 Adjacent to (within 5 mm) or invading the parietal pericardium

 To differentiate T3 lesions involving the mediastinal pleura from T4 lesions involving major vessels or organs, a chest MRI will be obtained. If any uncertainty remains, the patient will have four-dimensional CT scans (4DCT) in an effort to determine the degree of tumor motion. A freely mobile tumor during ventilation will be judged to be T3 disease.

 Patients with hilar or mediastinal lymph nodes <=1cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Patients with >1cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but non-diagnostic uptake) may be eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer.

 Primary tumor must be technically resectable by an experienced thoracic cancer clinician, with a reasonable possibility of obtaining a gross total resection with negative margins (potentially curative resection, PCR). However, patients must have underlying physiological medical problems prohibiting PCR (i.e., problems with general anesthesia, the operation, the post-op recovery period, or removal of adjacent functioning lung) or refuse surgery. Deeming a patient medically inoperable based on pulmonary function for surgical resection may include any of the following: baseline FEV1 <40% predicted; post-operative predicted FEV1 <30% predicted; severely reduced diffusion capacity; baseline hypoxemia and/or hypercapnia; exercise oxygen consumption <50% predicted; severe pulmonary hypertension; diabetes with severe end organ damage; severe cerebral, cardiac, or peripheral vascular disease; or severe chronic heart disease. Any one of these problems will qualify a patient for this trial.

 Age >=18.

 Zubrod performance status 0-2.

 Women of childbearing potential must use effective contraception.

 No direct evidence of regional or distant metastases after appropriate staging studies. No synchronous primary or prior malignancy in past 2 years except non-melanoma skin cancer or in situ cancer.

 No previous lung or mediastinal radiation therapy.

 No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemo, biologic, vaccine therapy, or surgery) while on this protocol except at disease progression.

 No active systemic, pulmonary, or pericardial infection.

 No pregnant or lactating women.

 PRESTUDY REQUIREMENTS:

 History and Physical Examination, Weight, Zubrod performance status (within 4 weeks pre-study entry)

 Evaluation by thoracic cancer clinician (within 8 weeks pre-study entry)

 Pregnancy test, if applicable (serum or urine, within 72 hours prior to treatment start.)

 CT (preferably with contrast unless medically contraindicated; both lungs, mediastinum, liver, adrenals)

 PET (using FDG with visualization of primary tumor and draining lymph node basins in hilar and mediastinal regions)

 Brain MRI or head CT with contrast

 PFTs - include routine spirometry, lung volumes, diffusion capacity

 Signed informed consent.

Exclusion criteria: :

 There is no

['Stereotactic Body Radiation Therapy (SBRT)']

['Inoperable Stage I/II Non-small Cell Lung Cancer']


Neural Correlates of Cognitive Rehabilitation in Post-Traumatic Stress Disorder (PTSD)

Summary: Post Traumatic Stress Disorder (PTSD) is an emotional disorder that can also lead to problems with attention and memory. Cognitive training has been successfully used to improve attention and processing speed in other patient populations as well as healthy elderly. The purpose of this study is to examine how effective cognitive training will be in Veterans with PTSD.
Inclusion criteria: inclusion criteria:

 OEF/OIF Veteran,

 meets DSM-IV criteria for PTSD,

 control group does not meet criteria for PTSD

Exclusion criteria: :

 prior history of significant head injury (LOC > 30 minutes) or other neurological disorder (e.g., stroke, seizure, multiple sclerosis), learning disability or confirmed diagnosis of ADHD,

 contraindication to MR imaging, failed malingering tests during testing, or a history of severe mental illness (i.e., Schizophrenia, Bipolar Disorder)

 individuals will be excluded if in the 30 days prior to the initial interview if they:

 do not have stable housing (i.e., staying in same residence),

 have medication changes or have had a psychiatric hospitalization,

 participants who meet DSM-IV criteria for substance dependence will be excluded from the study,

 individuals will also receive urine toxicology and Breathalyzer testing as the first procedure on the evaluation day (pre and post treatment and at 3 month follow up); participants who test positive for alcohol or recent substance use (e.g., methamphetamine) or report significant levels of drug or alcohol use if they are unable to abstain from substance use at three consecutive visits

 veterans who are currently engaged in therapy treatment for PTSD


Life Skills Intervention for Adolescents Perinatally Infected With HIV

Summary: The life skills intervention model is designed to help adolescents promote their physical and mental health through cognitive and behavioral techniques (e.g., problem solving, coping, and communication skills) designed to help them achieve social and personal competencies used to manage various life challenges.
Inclusion criteria: inclusion criteria:

 Clinically-identified HIV-1 infected participants 11-14 years of age and their primary caregivers.

 HIV status has been disclosed to the adolescent.

 Caregiver is the legal guardian of the adolescent as indicated by the medical team.

 Adolescent lives with the caregiver

 Adolescent and caregiver speak and understand English.

Exclusion criteria: :

 Caregiver consent or permission denied or adolescent does not assent.

 Adolescent diagnosed as mentally retarded as previously reported or confirmed through chart review.

 Adolescent and/or caregiver too medically fragile. Medically fragile is functionally defined as being physically unable to attend the group.


A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury

Summary: The purpose of this study is to evaluate if pregabalin relieves nerve pain associated with spinal cord injury compared to placebo (pill that contains no active medicine). This study will also evaluate the safety of pregabalin in this patient population.
Inclusion criteria: inclusion criteria:

 Subjects with nerve pain after Spinal cord injury (traumatic, diving, ischemic and after removal of benign tumors (except meningioma and fibromas)

 Pain has to be chronic(continuous for at least 3 months or intermittent for at least 6 months

 Pain score at least 4 in 4 of 7 days prior to receive treatment.

Exclusion criteria: :

 Pregabalin use in the last 60 days, prior intolerance to pregabalin

 Creatinine clearance <60 mL/min.

 White blood cell count <2500/mm3; neutrophil count <1500/mm3; platelet count <100 x 103/ mm3.

 Abuse of drugs or alcohol

 Unstable medial conditions

 Clinically significant abnormal electrocardiogram (ECG).

 Presence of severe pain associated with conditions other than spinal cord injury that could confound the assessment or self-evaluation of pain due to spinal cord injury.


A Novel Anterior Rhinoscopic Scoring Scale to Predict Nasal Insertability Before Transnasal Endoscopy

Summary: A sniff test for nasal patency is a common method before ultrathin transnasal esophago-gastro-duodenoscopy (UT-EGD) to select the right or left nostril for insertion, yet there is no objective method to select an appropriate meatus insertion site (MIS) where tolerance and epistaxis rate can be improved.~The investigators hypothesize that that an objective anterior rhinoscopy (to be more specific, the investigators term it anterior meatoscopy) method might be more effective than the subjective breathing-in method (sniff test) to select the appropriate meatus insertion site, thus reducing nasal bleeding and nasal discomfort.~The aim of this study is to evaluate the effectiveness of an endoscopic meatus scoring scale (EMSS) by anterior meatoscopy (AM) to select a MIS on patient tolerance and adverse events during nasal anesthesia and UT-EGD.~The investigators will perform a prospective randomized-controlled trial to compare patient tolerability and adverse events during nasal anesthesia and endoscopy between the AM-selected and self-selected MIS. A total of 233 consecutive patients with epigastric discomfort (symptoms of non-ulcer dyspepsia) will be included in the study in a large tertiary referral hospital in Taiwan.
Inclusion criteria: inclusion criteria:

 All outpatients with epigastric discomfort (non-ulcer dyspepsia), aged 18-65 years are eligible for this study.

Exclusion criteria: :

 Patients who have prior nasal trauma or surgery, recent or present upper gastrointestinal bleeding and coagulopathy are excluded from this study. Patients who are allergic to an anesthetic agent and who have uncontrolled hypertension or coronary artery disease are not recruited. Those who are uncooperative and unable to answer questions are also excluded.

['anterior meatoscopy', 'Nasal sniff test']

['Injury Due to Endoscopic Examination', 'Transnasal Endoscopy Induced Epistaxis', 'Transnasal Endoscopy Induced Nasal Pain']

Injury Due to Endoscopic Examination
Transnasal Endoscopy Induced Epistaxis
Transnasal Endoscopy Induced Nasal Pain


Alzheimer's Disease and Related Disorders

Summary: The purpose of this study is to compare characteristics of gait and balance measured among patients with Alzheimer's disease or related disorders separated into 3 groups according to the stage of disease (i.e., pre-dementia, mild and moderate dementia stages); to determine the effects of anti-dementia drugs and vitamin D on cognitive motor abnormalities; and to establish a database at Angers University Memory Centre.
Inclusion criteria: inclusion criteria:

 All elderly patients from the University Memory Center of Angers University Hospital.

 Able to walk without any walking aid on 15 meters

 Mini-Mental Status Examination score > 10

 Being affiliated to a social security regime

Exclusion criteria: :

 Mini-Mental Status Examination score ≤ 10

 Subject suffering from pre-existing impellent disturbances

 History of cerebrovascular accident or other cerebro-spinal pathology

 Poor workmanship of the written or oral French language

 Use of walking aid such as walking frame with wheels or tricycle.

 Acute medical or surgical disease in the past 3 months

 Refusal to participate (or trustworthy person)

 Near visual acuity < 2/10

["Alzheimer's Disease", 'Gait Apraxia', 'Impaired Cognition']

Alzheimer's Disease
Gait Apraxia
Impaired Cognition


A Longitudinal Investigation of the Endocrine and Neurobiologic Events Accompanying Puberty

Summary: Despite the clear importance of adolescence in the emergence of a number of disease states and processes, there is surprisingly little known about how the endocrine and metabolic events accompanying puberty in humans impact normal developmental neurobiology. Epidemiologic studies have identified sexual dimorphisms in the prevalence of several neuropsychiatric disorders, including depression, schizophrenia, and substance abuse. Many of these sex differences emerge during or shortly after puberty and are maintained until the 5th-6th decade of life. For example, the two-fold greater risk of unipolar depression in women compared with men does not appear until adolescence, and prior to puberty girls are not at increased risk relative to boys. Puberty is a structured, transitional process that can be influenced by both nutritional factors and environmental stressors; nonetheless, the variability in the timing and duration of puberty is largely determined by oligogenic inheritance. Basic neuroscience research has demonstrated that hormonal events accompanying puberty impact on many of the physiologic systems involved in the regulation of brain function (e.g., the appearance of new neurons in a brain-region specific pattern, neuronal remodeling, and the pruning of cortical connectivity). Additionally, not only does stress during puberty increase the risk of disturbances in affective adaptation during adulthood, but the events accompanying puberty modify stress responsivity (e.g., alterations in the duration and peak response of hypothalamic-pituitary-adrenal [HPA] axis hormones to stressors). Moreover, animal work has demonstrated that neural connectivity differs in a brain regional specific manner according to the stage of puberty (i.e., early versus late). In humans, puberty also occurs in stages, and although the endocrinology of puberty, surprisingly, has not been fully characterized with longitudinal data, studies have documented that the physical changes measured by Tanner stages I to V are accompanied by progressive increases in the secretions of both gonadal and adrenal steroids. Nonetheless, there remains considerable variability in the timing and duration of this otherwise highly structured reproductive transition.~We propose to perform a longitudinal, naturalistic study examining changes in brain structure and function, behavior, and stress responsivity in boys and girls across the pubertal transition. Because the pubertal transition is defined by a complex series of physiologic events that emerge sequentially over several years and involve changes in multiple endocrine and growth systems, and because there is also considerable variability in the timing of these events reflecting the influence of both genetic and environmental factors, puberty cannot by delineated by age of the participants as has been done in most imaging and other neurobiological studies of adolescence. The present study will formally bridge this gap by defining pubertal events per se in participants.~Participants will include healthy boys and girls whose pubertal status will be assessed, and in whom endocrine, metabolic, and brain imaging measures will be evaluated at eight - ten month intervals from age eight years (pre-puberty) until age 17 years (post-puberty). Reproductive endocrine, metabolic, and physical measures will be employed to characterize the stage and duration of pubertal development. Outcome measures will be derived via multimodal neuroimaging techniques, cognitive/behavioral assessments, metabolic measurements, and evaluations of HPA axis function. Additionally, the impact of genetic variation on the developmental trajectory of these parameters (both reproductive and CNS) will be determined.~This cross-institute proposal will employ a multidisciplinary approach to evaluating the effects on CNS function of the process of puberty in both boys and girls. This work will not only serve to inform research on the mechanisms by which sexual dimorphisms in neuropsychiatric disorders develop, it will also have important implications for the prevention and treatment of these disorders.~...
Inclusion criteria: inclusion criteria - SAMPLE 1:

 Child volunteers will qualify for inclusion if they meet the following criteria:

 Good general health and normal IQ; A normal IQ will be determined by the scores on Test of Irregular Word Reading Efficiency (TIWRE)

 Age 8 years;

 Body Mass Index (kg/m^2) between the 15th and 85th percentiles for age and sex according to the US Centers for Disease Control and Prevention 2000 growth charts;

 A normal tempo of growth as determined by skeletal age within +/- 1.64 standard deviations of chronologic age according to the Greulich and Pyle radiographic atlas (i.e., no evidence for precocious puberty or abnormal delay of maturation); Research criteria for determining bone age will be performed by the collaborating pediatric endocrinologist. This criterion is required only for the initial entry into this study and is not one of the inclusion criteria for subsequent visits;

 No history of significant neurologic or cognitive disorders. Examples include neonatal anoxic encephalopathy, seizure disorders, autism, and most learning disorders including attention deficit hyperactivity disorder;

 Able to provide assent. Parents will provide consent.

Exclusion criteria:  - SAMPLE 1:

 Child volunteers will be excluded for the following reasons:

 Presence of any medical condition that increases risk for MRI (e.g., pacemaker, metallic foreign body in eye or other body part, dental braces);

 Presence or history of medical conditions known to affect cerebral anatomy;

 Children who are not pre-pubertal as indicated by the presence of Tanner stage 2 development (i.e., areolar development in girls and testicular volume > 3 cc in boys);

 Individuals who have, or whose parent or guardians have, current substance abuse or a psychiatric disorder or any other condition which, in the opinion of the investigators, would impede the ability to give informed consent or possibly hinder completion of the study; presence of any psychiatric disorder in the subject, sibling, or other first-degree relative;

 Subjects who regularly use prescription medications (the use of over-the-counter medications will be reviewed on a case-by-case basis.);

 For females who have reached menarche: Pregnancy, lactation, or inability or unwillingness to undergo pregnancy testing (a urine pregnancy test will be performed prior to all MRI and X-ray procedures for girls who have had the onset of menses);

 Current or past use of psychiatric medication;

 I.Q. < 70.

 NIMH employees and staff and their immediate family members will be excluded from the study per NIMH policy.

 inclusion criteria - SAMPLE 2:

 Child volunteers will qualify for inclusion if they meet the following criteria:

 Good general health and normal IQ; A normal IQ will be determined by the scores on Test of Irregular Word Reading Efficiency (TIWRE)

 Ages 12-13 years;

 Body Mass Index (kg/m^2) between the 15th and 85th percentiles for age and sex according to the US Centers for Disease Control and Prevention 2000 growth charts;

 A normal tempo of growth as determined by skeletal age within +/- 1.64 standard deviations of chronologic age according to the Greulich and Pyle radiographic atlas (i.e., no evidence for precocious puberty or abnormal delay of maturation); Research criteria for determining bone age will be performed by the collaborating pediatric endocrinologist. This criterion is required only for the initial entry into this study and is not one of the inclusion criteria for subsequent visits.;

 No history of significant neurologic or cognitive disorders. Examples include neonatal anoxic encephalopathy, seizure disorders, autism, and most learning disorders including attention deficit hyperactivity disorder;

 Able to provide assent. Parents will provide consent.


Sonography After Thoracic Surgery (SATS)

Summary: Lung cancer remains the leading cause of mortality from malignant diseases in both men and women worldwide. Following thoracic surgery and pulmonary resection, patients have a surgically induced pneumothorax / hydro-hemothorax and hence tube thoracostomy is necessary to drain the air and effusion. Due to this, patients must undergo post-operative chest x-ray (CXR) evaluations in order to evaluate the chest and make decisions regarding removal of chest tubes (CT) as well as for decisions regarding patient discharge. Thoracic Ultrasound (US) has been shown to be accurate at diagnosing pneumothorax and has been well-studied in the trauma population. To the investigators knowledge, there are currently no centers using thoracic US routinely in the post-operative setting following thoracic surgery.
Inclusion criteria: inclusion criteria:

 Patients undergoing elective, open and thoracoscopic thoracic surgery for any indication

Exclusion criteria: :

 Age < 18 years old

 Inability to consent for the study

 Chest wall anatomy precluding SATS

 Inability to sit upright


A Multicentre Randomised Controlled Trial Comparing Two Strategies for the Diagnosis of Invasive Aspergillosis in High-risk Haematology Patients

Summary: Aspergillus is a fungus found in soil, on farms and on construction sites. In those whose immune system is impaired it causes severe infection. The people who are particularly at high-risk of infection with Aspergillus (which is called Invasive Aspergillosis)are those with acute leukaemia who are having chemotherapy and those post bone marrow transplantation. Currently 15% of those at high-risk develop Invasive Aspergillosis and 60-90% of those with Invasive Aspergillosis die.~The main reason for this high death rate is that our current diagnostic tests are not good at detecting infection or often only detect the infection at advanced stages when treatment is ineffective. Because of the limitations of current diagnostic tests the current practice is to give empiric antifungal therapy (EAFT) early to treat suspected Invasive Aspergillosis. However studies have demonstrated that this therapy has only resulted in a minor reduction in the mortality rates and it also causes significant drug toxicity. It is a suboptimal treatment modality.~New tests have recently been developed to diagnose Invasive Aspergillosis. These tests are for the detection of an Aspergillus protein in blood and for the detection of Aspergillus DNA in blood. Available data suggests that these new tests make an early diagnosis and seem to be able to monitor responses to treatment. However no study has been reported to date which demonstrates that the use of these tests can impact on important patient outcomes. This trial is being performed to determine whether the use of the new diagnostic tests to guide antifungal therapy will help improve treatment of Invasive Aspergillosis, reduce drug toxicity and reduce the death rate in the high-risk patients as compared with the current standard method of diagnosis and treatment with EAFT.
Inclusion criteria: inclusion criteria:

 Patients fulfilling all the following criteria will be eligible for enrolment 1. Aged 18-80 years 2. Undergoing allogeneic haematopoietic stem cell transplantation (HSCT) for any reason OR Undergoing intensive combination chemotherapy for acute myeloid leukaemia (AML) or acute lymphoblastic leukaemia (ALL) 3. Has given written informed consent.

 -

Exclusion criteria: :

 Patients with any of the following will be ineligible for enrolment 1. Other immunocompromised states (e.g. HIV infection, solid organ transplantation, autoimmune conditions treated with immunosuppressants etc.) besides those outlined in the inclusion criteria above 2. Currently enrolled in an antifungal treatment trial (not an antifungal prophylaxis trial) 3. Past history of proven or probable IA (as per standardized definitions) during a previous cycle of chemotherapy 4. Currently have active IA or other active invasive fungal infection 5. Prior enrolment in this study

 -

['Culture and histology', 'Aspergillus galactomannan and PCR']

Culture and histology
Aspergillus galactomannan and PCR


Evaluating the Relationship Between Sleep-Disordered Breathing and Daytime Alertness

Summary: Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person repeatedly stops breathing, or experiences shallow breathing for short periods of time during sleep. Daytime sleepiness is a common symptom of OSA and may affect an individual's level of alertness throughout the day. The primary purpose of this study is to evaluate the relationship between the severity of sleep-disordered breathing and levels of daytime alertness at baseline (untreated state) in a group of subjects with and without sleep apnea. In addition the change in daytime sleepiness in subjects with sleep apnea being treated with a continuous positive airway pressure (CPAP) machine, a common treatment for OSA will also be assessed.
Inclusion criteria: inclusion criteria:

 Experiences symptoms of OSA, including snoring and sleepiness

 Stable medical history with no change in medications that could affect sleepiness

Exclusion criteria: :

 Suspected diagnosis of a sleep disorder other than OSA (i.e., periodic leg movements, narcolepsy, insomnia, central sleep apnea, sleep hypoventilation syndrome)

 Medically unstable health conditions (e.g., heart attack, congestive heart failure)

 Use of psychotropic medications that cause sedation in the 3 months prior to study entry

 Recent or confirmed history of recreational drug use or alcohol abuse

 Pregnant

 Inability to communicate verbally, write, or read

 Visual, hearing, or cognitive impairment

['Continuous Positive Airway Pressure (CPAP)']


The Effects of Therapy With Teriparatide on Vascular Compliance and Osteoprotegerin/RANKL

Summary: The purpose of this study is to determine what effect teriparatide will have on vascular (blood vessel) compliance and osteoprotegerin (bone fluid)and RANKL levels (bone cells).
Inclusion criteria: inclusion criteria:

 Postmenopausal women and men over the age of 40 who are starting therapy with teriparatide

Exclusion criteria: :

 Patients with diabetes mellitus

 current smokers

 patients with a history of organ transplantation

 Patients currently of previously on glucocorticoid therapy within the past year

 Patients with serum creatinine above 1.5 mg/dl, patients with uncontrolled hypertension (BP 140/90 or greater)

 Patients ineligible for teriparatide therapy: History of metabolic bone disease other than osteoporosis

 History of radiation therapy

 Patients pregnant or nursing

 History of bone metastasis or skeletal malignancies

 History of hypercalcemia


Characteristics of Sleep Patterns in Young Adults With and Without Insomnia

Summary: This study will compare the symptoms, experiences, and laboratory sleep characteristics of young adults with and without insomnia.
Inclusion criteria: inclusion criteria:

 Physically healthy

 Meets DSM-IV criteria for primary insomnia

 For subjects interested in PET study only: right-handedness

Exclusion criteria: :

 Currently taking antidepressants, antianxiety medications or medications for sleep disorders

 Currently experiencing symptoms of psychiatric disorders such as major depressive disorder, bipolar disorder, generalized anxiety disorder

 Significant or unstable acute or chronic medical conditions, such as seizure disorder, tumor, liver disease, active peptic ulcer disease, arthritis, irritable bowel disease

 Meets DSM-IV criteria for sleep apnea or periodic limb movement disorder


Characteristics of Patients With Missed Pulmonary Embolism in the ED: A Three Year Experience

Summary: The clinical presentation of acute pulmonary embolism ranges from mild dyspnea and cough to shock or sustained hypotension but it also may even be asymptomatic and diagnosed by imaging procedures performed for other purposes. (1) Depending on the clinical presentation, the case fatality rate for acute pulmonary embolism ranges from 1% up to 60%. Due to the often non-specific presentation, especially in mild to moderate acute pulmonary embolism PE is often underdiagnosed. Chest pain and shortness of breath are the two most common symptoms associated with pulmonary embolism, together these symptoms are responsible for approximately 10 million emergency department visits in the United States of America (US) (2). The aim of this study was to determine the sensitivity and specificity of diagnosing pulmonary embolism (PE) at the emergency department (ED) of the University Hospital Basel and the investigators have therefore retrospectively analyzed all cases with excluded or proven PE in our institution in the last three years. Data sets from the institute of radiology, the institute of pathology and the ED are consistently available from January 2011 until the present day and were screened for pulmonary embolism in discharge reports. Data from the ED include all patients between January 2011 and December 2013 that presented to the ED and received either an ECG or any form of thoracic imaging. Particular attention was paid to patients with PE in the discharge report. The third set of data includes all patients with PE as cause of death or as a secondary diagnosis in the autopsy report. After comparing the three sets of data to each other the investigators tried to determine the sensitivity and specificity of PE diagnosis at the ED respectively the rate of missed diagnoses. A PE was seen as missed if it is detected 24h after the patient presented to the ED or if it was detected at another department after the patient was transferred from the ED.
Inclusion criteria: inclusion criteria:

 patients 18 years of age or older,

 presented to the ED between January 2011 and March 2014,

 who received an ECG or any form of thoracic imaging.

Exclusion criteria: :

 patients below 18 years of age, as well as patients referred to the ED with suspected PE by departments within UHBS, other hospitals, or other healthcare providers

['Missed Pulmonary Embolism at the Emergency Department']


The Effects of Combining Modified ride-on Cars With Bimanual Training on Enhancing Mobility, Socialization, Motor Function and Participation in Toddlers With Disabilities

Summary: The four purposes of this study are: 1) to examine the feasibility of combining modified ride-on cars with bimanual training (ROCBT) on mobility, socialization and motor function in toddlers with disabilities; 2) to quantify whether toddlers with disabilities are able to have more manual explorations and social interactions with ROCBT through observation and wrist-worn accelerometers; 3) to determine the critical factors of using the modified ride-on toy car on family perceptions and participation.~Independent mobility is believed to be essential for perceptual-motor, cognition, language and social skill development. It is important to increase independent mobility in toddlers with disabilities and further enhance their development, especially socialization. Assistive and power mobility devices allow toddlers with disabilities to move independently within their environment and may increase the opportunities to explore and interact with people and environment. However, issues to consider before prescribing an assistive device include factors such as age, accessibly to community environments, cost, and social acceptance of the device and the adaptability of the device to growth. To address these limitations and meet toddlers' needs, the concept of using modified ride-on toy cars in therapy becomes a novel application. Study has demonstrated the use of toy cars enhanced a child's motivation, socialization and family participation. This study is further to combine the use of customized, modified ride-on toy cars with bimanual training, to enhance the independent mobility, manual exploration and socialization through low-cost, family-centered approach. It will also improve family's understanding of children's capabilities, which improve their development.~Investigators will recruit 75 children with who are between 1 to 3 years old and diagnosed as motor delay (>1.5 sd). They will be randomly assigned to one of the following three groups: ROCBT treatment group, early mobility training group and regular therapy group. The whole study duration will be 18 weeks, including 9-week intervention and 9-week follow-up; the total amount of treatment will be equal for two groups. Standardized assessments are provided for a total of three times during the study, including the time before and after the intervention and in the end of the follow-up phase. The ROCBT and early mobility training programs will be administered by the therapist and include 120 minutes/per session, 2 sessions/per week. The research team will visit the hospital once/per week to provide 60 minutes videotaping and wearing wrist-worn accelerometers. The regular therapy group will continue their regular therapy without any additional car driving training. The research team will visit them once/per week for the assessments. The assessments include standardized measurements and behavior coding from the videotapes and accelerometers. The findings of this study will help to understand the feasibility and effectiveness of combining the low-tech modified ride-on cars with bimanual training on advancing children's mobility and socialization. They can be used in the clinic or school and are a low cost alternative or addition to other mobility devices. They may provide a novel therapeutic tool to improve mobility, socialization, family participation and development.
Inclusion criteria: inclusion criteria:

 motor delays (sd>1.5) resulting in motor impairments that prevented functional independent mobility, such as rolling, crawling, walking;

 aged between 12 months to 36 months old

 able to tolerate sitting with support for 30 minutes

 able to reach the objects with either one or two hands

 consent of the parents to agree to the testing procedures and participate in the training program at the hospital.

Exclusion criteria: :

 children with severe sensory impairments such as blindness, deafness

 parents/caregivers are not able to make a time commitment for the training phase

['Ride-On Cars with Bimanual Training Program (ROCBT)', 'Early Mobility Training Program', 'Regular Therapy Program']


Invasive Group A Streptococcus (GAS) Infection in Children: Bacterial Virulence Factors and Detection of Host Immunological and/or Genetic Factors of Predisposition to Infections

Summary: The main objective of the study is to characterize the virulence factors of SGA and identify immunological and / or genetic factors predisposing to infections in children hospitalized with invasive GAS infection.
Inclusion criteria: inclusion criteria:

 Age ≥ 1 month to <15 years at the time of inclusion

 Group 1 : Children hospitalized for invasive GAS infection

 Subgroup 1A ( N = 75 ): Children with invasive infection without known risk factor .

 Subgroup 1B (N = 75) : Children with invasive infection with known risk factor .

 GAS Invasive infections are defined by:

 a) Proved infection : Bacteriological isolation of S. pyogenes from a liquid or a normally sterile site, except from a blister of a simple erysipelas, without necrosis . This is sometimes associated with a shock with multiorgan failure (streptococcal toxic shock syndrome ( STSS )) b ) Probable infection :

 . Bacteriological isolation of S. pyogenes from a normally non-sterile site ( eg skin, upper respiratory tract ) associated with extensive soft tissue necrosis

 . Bacteriological isolation of S. pyogenes a site or a biological sample usually non-sterile ( eg skin , upper respiratory tract ) associated with a evocative shock syndrome STSS and no other cause found .

 Contributing factors for invasive infection are defined by:

 cutaneous effraction (wounds , burn , chicken pox ), the use of corticosteroids or other treatment, immunosuppressive and recent surgery

 • Group 2: non-invasive infection such as pharyngitis , tonsillitis, proctitis or skin infection diagnosed by a positive test for rapid diagnosis of GAS performed at the site of infection with a positive GAS culture.

Exclusion criteria: :

 Group 1: Children with a known immune deficiency unrelated to the risk factors described above.

 Group 2: Children with a known immune deficiency.


Prospective Study of Rapamycin for the Treatment of SLE

Summary: Systemic lupus erythematosus (SLE) is an autoimmune disease of unknown origin. It involves multiple organs including the joints, skin, kidneys and central nervous system. The disease process is caused by a dysfunction of the immune system. The drugs currently used for the treatment of SLE are only partially effective and carry significant risks for side-effects. Rapamycin, also called sirolimus or Rapamune, has been approved by the FDA to prevent rejection of organ transplants at daily doses of 2 mg to 8 mg. Patients that were resistant or intolerant to conventional medication have been effectively treated with Rapamycin and were able to decrease the amount of prednisone they needed.~The purpose of this study is to prospectively determine the therapeutic efficacy and mechanism of action of Rapamune in patients with SLE. Healthy subjects not receiving Rapamune will be asked to donate blood to serve as controls.~As part of the research effort to understand the reason for the variations in the effects of treatment drugs by different individuals, a sub-study of the DNA makeup of subjects enrolled in the trial will also be done. The purpose of the sub-study is to possibly determine whether different responses to the drugs used to treat SLE have a correlation with the differences in the genetic makeup of the subjects.
Inclusion criteria: inclusion criteria:

 For SLE Subjects:

 SLE patients who exhibit ongoing disease activity by SLEDAI greater or equal to 4.

 SLE patients whose disease activity is controlled by administration of corticosteroids, most commonly, at least 10 mg/day of prednisone.

 18 years of age or older.

 Updated vaccinations prior to study entry.

 Use of effective contraception for male patients before, during and up to 12 weeks after sirolimus therapy.

 For Healthy Control Subjects:

 18 years of age or older

 Must be matched with one of the SLE patients enrolled in the study by age, gender and ethnic origin

 Must not have any acute or chronic illness.

Exclusion criteria: :

 For SLE Subjects:

 Patients who are pregnant.

 Patients with allergy or intolerance to sirolimus.

 Patients with life-threatening manifestations of SLE.

 Patients with proteinuria exceeding 500 mg/24 h or urine protein/creatine ratio >0.5.

 Patients with total cholesterol > 300 mg/dl or triglyceride > 400 mg.dl will be excluded.

 Patients with acute infection requiring antibiotics.

 Patients on sirolimus who develop infections and require intravenous antibiotics and fail to show clinical improvement in 5 days.

 Patients concurrently undergoing B cell-depleting therapy, cyclophosphamide, cyclosporine, and tacrolimus.

 Patients who have received investigational biologic B-cell depleting products within one year of study initiation.

 Patients with a history of chronic viral infections (e.g., HIV, hepatitis B, hepatitis C) or with a history of a malignancy (except non-melanoma skin cancer).

 Due to interference with sirolimus metabolism, subjects will not be allowed to receive concomitant rifampin, ketoconazole,voriconazole, itraconazole, erythromycin, or clarithromycin during the study.

 Patients with any type of interstitial lung disease.

 For Healthy control Subjects:

 Subjects who are pregnant.

 Subjects with any acute or chronic illness.


Radiologic Features of Invasive Pulmonary Aspergillosis

Summary: Invasive pulmonary aspergillosis (IPA) is an opportunistic infection that primarily affects recipients of solid organ transplants (SOTs) and patients with chemotherapy- induced neutropenia.Although both of these populations are at high risk for IPA, they differ with regards to the specific defects in host defense mechanisms that increase their risk for IPA. Chemotherapy- induced neutropenia is the principal defect affecting patients with hematologic malignancies, whereas transplant recipients tend to have dysfunctional T cells and phagocytes, as a result of immunosuppressive drug therapy. Thus, the patterns of IPA-related infection and inflammation may differ according to the type of underlying immune defect. Although the clinical and radiological features of IPA in patients with neutropenia have been extensively studied, little is known about the characteristics of IPA in SOT recipients. The investigators therefore compared the IPA- related clinical and radiological findings in SOT recipients with those of neutropenic patients.
Inclusion criteria: inclusion criteria:

 IPA cases with solid organ transplant recipients and hematologic disease patients

 proven and probable invasive pulmonary aspergillosis by modified EORTC/MSG criteria

Exclusion criteria: :

 under 16 years old

 possible cases of invasive pulmonary aspergillosis

['Hematologic Disease', 'Solid Organ Transplantation']

Hematologic Disease
Solid Organ Transplantation


Evaluate the Clinical Effectiveness of RegenKit Platelet-rich Plasma (PRP) in Androgenetic Alopecia Treatment

Summary: Platelet rich plasma (PRP) therapy is a novel therapeutic modality that has seen broad applications for a number of medical indications including those in orthopedics, dentistry, and dermatology. In dermatology, its uses have included treatment of chronic wounds and facial rejuvenation. More recently, anecdotal reports have suggested some efficacy in the treatment of hair loss, but to the best of our knowledge, there has been only one published case series documenting its use for this indication.
Inclusion criteria: inclusion criteria:

 Men and women, age 18-60 with AGA

 Completed informed consent form

 Ludwig stage 1-2 for women

 Norwood Hamilton Stage 3 to 5 for men

Exclusion criteria: :

 Pregnancy or breastfeeding

 Younger than 18 years

 Uses of minoxidil and/or 5-alpha reductase inhibitors (such as finasteride or dutasteride) within 3 months of enrolling in the study

 History of hair transplantation

 Use of any cosmetic product aimed at improving or correcting the signs of hair loss within 2 weeks prior to screening

 Facial cancer (squamous and basal cell carcinoma, melanoma)

 Hereditary or acquired hematologic/coagulation disorders such as: platelet dysfunction syndrome, critical thrombocytopenia, hypofibrinogenemia, impaired coagulation, drepanocytosis (sickle cell anemia).

 Hemodynamic instability

 Acute infection

 Auto-immune disease such as Hashimoto, rheumatoid arthritis, or lupus (exception: vitiligo and alopecia areata)

 Malignancy with or without metastatic disease

 Chemotherapy

 Dermatological diseases affecting the face (e.g. porphyria)

 Anticoagulant therapy

 Patients taking Aspirin or other NSAIDs (Nonsteroidal anti-inflammatory drugs) such as Nurofen, Voltaren, Diclofenac or Naproxen can participate, provided medication is interrupted 7 days before beginning of the treatment

 Patients taking vitamin E supplements can participate, provided medication is interrupted 14 days before beginning of the treatment

['Autologous Platelet Rich Plasma', 'Saline solution injection']

Autologous Platelet Rich Plasma
Saline solution injection


A Study of the Long-Term Outcomes of HIV-Positive Patients

Summary: The purpose of this study is to collect information about life spans and HIV-related illnesses in multiple groups of HIV-positive patients with varying anti-HIV treatment experience, including no treatment at all.~Anti-HIV treatment has been successful in slowing disease progression in many patients. However, there are still questions regarding the best way to use anti-HIV drugs. This study is designed to provide long-term monitoring of patients who have already received anti-HIV treatment as well as patients who are just beginning treatment or have decided not to receive treatment.
Inclusion criteria: inclusion criteria

 Patients may be eligible for this study if they:

 Are 13 years of age or older (consent of parent or guardian required if under the age of 18).

 Are HIV-positive.

 Have either: (1) no previous experience with anti-HIV treatment (defined as no previous protease inhibitor or nonnucleoside reverse transcriptase inhibitor use, 1 week or less of lamivudine use, and 4 weeks or less of cumulative nucleoside reverse transcriptase inhibitor use) or (2) current or previous enrollment in a qualifying CPCRA study.
Exclusion criteria:


Early Invasive Versus Conservative Therapy in Women With an Acute Coronary Syndrome

Summary: The aim of this research is to evaluate the effect of early invasive therapy and appropriate revascularization compared with conservative management and selective revascularization among women with an acute coronary syndrome.
Inclusion criteria: inclusion criteria:

 Women age 18 years or older

 Non-ST-elevation acute coronary syndrome (defined as new onset chest discomfort that occurs at rest or with low levels of activity/or emotion within the preceding 48 hours) with either:

 elevated troponin T (≥ 0.03 ng per milliliter),

 elevated creatinine kinase MB-isoenzyme (≥ 5.0 ng per milliliter)

 elevated NT-pro-BNP (≥ 450 pg per milliliter),

 ST-segment depression (≥ 0.5 mm)

 or TIMI risk score (> 2)

 women who have elevated cardiac enzymes after non-cardiac surgery will also be considered.

Exclusion criteria: :

 ST-elevation myocardial infarction,

 cardiogenic shock,

 congestive heart failure,

 hemodynamic instability,

 use of fibrinolytic therapy in the last 96 hours,

 current bleeding or bleeding disorder within the last 3 months that required transfusion,

 pregnancy,

 contraindication to any study medication. i.e.heparin, clopidogrel, or glycoprotein IIb/III inhibitor,

 PCI in the last 6 months,

 prior CABG,

 inability to provide written informed consent.

['coronary angiography', 'adenosine stress test']

coronary angiography
adenosine stress test


Different Approaches for Delivery of IPT in Pregnancy in Burkina Faso

Summary: IPT/SP was adopted in 2005 by The Ministry of Health (MoH) of Burkina Faso to replace chemoprophylaxis with CQ in pregnancy. The new strategy is being implemented but no delivery approach was defined and presumably IPT/SP will only be delivered to pregnant women presenting at ANC visits. It would be of extreme importance to ensure a better coverage and higher compliance to make the new strategy effective. In order to obtain a more efficient IPT/SP programme with a good level of compliance and coverage, several delivery approaches beside ANC should be explored.~The study site will be in Pissy health district covering both peri-urban Ouagadougou city and rural areas. Participants include pregnant women irrespective of gravidity residing in the study area.~The study is a prospective comparative study of 3 different approaches of delivering IPT/SP in the catchment areas of rural health facilities. The approaches will be the following:~Passive health centre based delivery approach (PHC). IPT/SP will be delivered to pregnant women presenting to the health centre for ANC visits.~Joint, with an advanced strategies delivery approach (JAS). In addition to passive delivery at health centres, the pregnant women will be reached during preventive activities the health staff carry out regularly in villages, such as immunization, health promotion, and even ANC visits.~Community based distribution delivery approach (CBD). In addition to passive delivery at health centres, the pregnant women will be reached by traditional birth attendants (TBAs) or representatives of village women's associations (RWAs). Each approach will be implemented in a zone constituted by the catchment area of a number of health centres to achieve the required sample size. The zones will be randomly assigned to a delivery approach. The main outcomes to be measured are: a) the coverage of IPT, b) compliance, c) infection prevalence, d) Hb level, e) difficulties and constraints of each approach, f) the acceptability to population and health staff and g) the performance of each approach to deliver IPT /SP. to be able to identify a significant increase in coverage of 10%, each group should be composed of n = 3841 pregnant women.~Cross sectional surveys will be carried out at the beginning, during and at the end of the study period. The study will be carried out over 24 months from June 2007.
Inclusion criteria: inclusion criteria:

 Pregnant women of all parities

 Second trimester

Exclusion criteria: :

 Severely ill pregnant women

 Pregnant women in first trimester

['delivery approaches of malaria intermittent preventive treatment in pregnancy']

['Malaria Parasitaemia', 'Birth Weight', 'Anaemia']

Malaria Parasitaemia
Birth Weight
Anaemia


Brain Computer Interface (BCI) Based Robotic Rehabilitation for Stroke

Summary: The trial aims to test a novel rehabilitation device for subacute stroke hemiplegic upper limbs based on state-of-the-art non invasive Brain-Computer Interface (BCI) robotic rehabilitation in a clinical setting. The investigators aim to prove the clinical efficacy and safety of BCI therapy over traditional rehabilitation methods.
Inclusion criteria: inclusion criteria:

 Demographics: 21 to 65 years, within 12 months of first, single clinical stroke (ischaemic or haemorrhagic).

 Moderate to severe upper extremity (UE) weakness post stroke.

 Fugly-Meyer motor score of the upper limb < 40.

 Upper limb motor power MRC grade 3 or less /5 in at least 1 arm region.

 Able to give own consent and understand simple instructions and learn through practice.

 Resting brain states determined by FMRI criteria

Exclusion criteria: :

 Recurrent stroke.

 Previous brain surgery.

 Spasticity of Modified Ashworth scale > 2.

 Fixed contracture of any upper limb joint

 Ataxia, dystonia or tremor of the involved upper limb or previous cervical myelopathy

 Upper limb pain or painful joints in upper limb.

 Severe cognitive impairment (Abbreviated Mental Test <7/10), or severe aphasia which may affect ability to participate in training.

 . History of seizures in the past 12 months.

 Severe left neglect


Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder

Summary: This study will evaluate the effectiveness of flutamide in reducing symptoms of premenstrual dysphoric disorder.
Inclusion criteria: inclusion criteria:

 Meets DSM-IV criteria for PMDD by history

 Regular menstrual cycles that are 25 to 35 days in length during the year prior to study entry

 Willing to use barrier methods of birth control during the study if sexually active

 If engaged in psychotherapy for at least 3 months before study entry, participation will be allowed if the intensity of psychotherapy remains the same during the study

 Normal PAP and physical exam, including pelvic exam, within the 1 year prior to study entry

Exclusion criteria: :

 Use of oral contraceptives or other exogenous hormone preparations within the 3 months prior to study entry

 Suicide attempt or severe suicidal ideation within the 2 years prior to study entry

 History of any psychotic disorder or bipolar disorder

 Substance abuse, except nicotine, within the 6 months prior to study entry

 Use of pharmacological treatment for PMDD symptoms (e.g., antidepressants, hormones, gonadotropin-releasing hormone agonists, anxiolytics, calcium, herbal preparations, diuretics) within the 3 months prior to study entry

 Daily use of psychotropic or anticonvulsant medications within the 3 months prior to study entry

 Use of sleeping pills more than once per week

 Consumption of more than 50 ounces of alcohol per week

 Pregnant or breastfeeding

 Hepatic, renal, autoimmune, or chronic inflammatory disease

 Seizure disorder

 Inability to read or follow instructions in English


Microvascular Blood Flow in Sickle Cell Anemia

Summary: Sickle cell disease (SCD) is an inherited blood disorder that causes the red blood cells to change their shape from a round shape to a half-moon/crescent or sickled shape. Sickle-shaped cells can cause problems by getting stuck in blood vessels, blocking blood flow, and can cause inflammation and injury to important body parts. There are no specific treatments that improve this condition and promote blood flow hindered by sickle cell blockages. Another big challenge in managing sickle cell disease is that there are no good measures to determine changes and improvements in blood flow.~Contrast-enhanced ultrasound is a technique currently used to detect blood flow in the heart, muscles, and other organs. It is extremely sensitive and can detect blood flow in the smallest of blood vessels. It would be very useful in helping healthcare providers know whether treatment strategies are improving blood flow during sickle cell blockages.~The hypothesis is that contrast-enhanced ultrasound will be a feasible tool for determining changes in blood flow of subjects with sickle cell disease.
Inclusion criteria: inclusion criteria:

 Regadenoson ARM inclusion criteria:

 Diagnosis of sickle cell anemia confirmed by hemoglobin analysis

 Ages 18 to 70 years

 Subjects must have laboratory indices as outlined by the protocol

 Reliable IV access as determined by physician

 Sickle Cell Controls ARM inclusion criteria:

 Diagnosis of sickle cell anemia confirmed by hemoglobin analysis

 Ages 18 to 70 years

 Sickle Cell CEU ARM inclusion criteria:

 Diagnosis of sickle cell anemia, confirmed by hemoglobin analysis

 Males and females age 18-70 years

 Healthy Control ARM inclusion criteria:

 African American

 Ages 18 to 70 years

 Technique Optimization Control ARM inclusion criteria:

 -Ages 18 to 70 years

Exclusion criteria: :

 Regadenoson ARM

['regadenoson infusion with contrast-enhanced ultrasound', 'contrast-enhanced ultrasound', 'contrast-enhanced ultrasound', 'contrast-enhanced ultrasound', 'contrast-enhanced ultrasound']

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


Evaluating the Effectiveness of a Community Based Intervention for Persons With Dementia and Their Caregivers in a Developing Country

Summary: The aim of this trial was to apply a home based, flexible, stepped-care intervention designed to improve the awareness and knowledge of family caregivers regarding dementia, to maximise their caregiving resources and to improve their caregiving skills. A Randomized Controlled Trial (RCT) will be used to evaluate the same wherein the intervention group will get the services immediately and the control arm would receive the same after a period of 6 months.
Inclusion criteria: inclusion criteria:

 All probable cases will be examined by a trained clinician (AD) to confirm the diagnosis of dementia according to DSM IV criteria and graded using the Clinical Dementia Rating (CDR) Scale.

 CDR mild and moderate dementia.

 The principal caregiver, as identified by the family, was enrolled for the trial. The principal caregiver was generally the spouse, although in some instances another family member was the principal caregiver, particularly when the spouse was not in a position to care.

Exclusion criteria: :

 CDR severe dementia or severe co-morbid physical health conditions.

['Home based, flexible, stepped care intervention', 'Home based, flexible, stepped care intervention after 6 months. Families will be free to choose any health care they desire during the waiting period.']

['Dementia', 'Behavioral Symptoms', 'Mental Health']

Dementia
Behavioral Symptoms
Mental Health


Mild Cognitive Impairment in Parkinson's Disease

Summary: Mild cognitive impairment, including difficulty with solving problems, planning, attention, or recalling information, can be a significant problem for individuals with Parkinson's disease. Even mild cognitive difficulties can lead to worse functioning, quality of life, depression, and difficulty for caregivers. Thus, ideally treatment at this stage would improve both cognitive symptoms and some of the other problems associated with these symptoms.~Despite the fact that mild cognitive impairment is a serious problem for Parkinson's disease patients little is known about how best to treat it. This study is a 24-week clinical trial to see if a Food and Drug Administration (FDA)-approved drug, the Exelon (rivastigmine) Patch, is useful in treating mild cognitive impairment in patients with Parkinson's disease. Currently, the Exelon (rivastigmine) Patch is FDA-approved for the treatment of mild to moderate dementia in Alzheimer and Parkinson's disease patients.
Inclusion criteria: inclusion criteria:

 Participants must be experiencing symptoms of mild cognitive impairment; this will be determined by study personnel.

 Participants must be on a sable medication regimen for 2 months prior to starting the study (necessary dose adjustments during the study are acceptable).

 Participants are capable of giving informed consent supported by not meeting Parkinson's disease Dementia criteria; this will be determined by study personnel.

Exclusion criteria: :

 Active suicide ideation.

 Weighing less than 100 lbs (45 kgs).

 History of Deep Brain Stimulation surgery.

 Diagnosis of Dementia

 Taking certain types of medications may be an

['Exelon Patch (rivastigmine transdermal system)', 'Placebo Patches']

["Parkinson's Disease", 'Mild Cognitive Impairment']

Parkinson's Disease
Mild Cognitive Impairment


Normative State and Variation in Growth, Hematology, Hydration, Oxidation, Infection, Inflammation, Guatemalan Children

Summary: This study will provide the researchers with an opportunity for the investigation of the biomarkers and different human biology component variable interactions in children; information that can generate new correlations between markers not known at the moment.~Regarding their analysis, variation could have multiple connotations. A categorical that refers to a specific state, established with a diagnostic standard. And a numerical, referring to a range or the absolute value limits in a continuous spectrum; this research will allow us to express variability in the distance amplitude of the obtained values level, as well as classifications or categories previously established in the possible cases.~OBJECTIVES PRINCIPAL OBJECTIVE~To estimate the inter and intra-individual variety in a selected series or biological variables determinant of growth, body composition, infection, oxidation, inflammation and hydration, in preschool children sharing the same institutional-based diet.~SPECIFIC OBJECTIVES~To determine the inter and intra-individual variation of growth in preschool children, with a similar diet, who attend Secretariat of Beneficial Works of the First Lady system daycare centers and to compare between semi-urban and rural.~To describe the inter-individual variation of the red blood cells circulating mass in preschool children, with a similar diet, who attend day care centers and to compare between semi-urban and rural.~To determine the inter-individual variation of systemic and intraintestinal oxidation in preschool children, with a similar diet, who attend daycare centers and to compare between semi-urban and rural.~To describe the inter-individual variation of systemic and intraintestinal inflammation in preschool children, with a similar diet, who attend daycare centers and to compare between semi-urban and rural.~To determine the inter and/or intra-individual variation of urinary tract infection and gastrointestinal parasite infestation in preschool children, with a similar diet, who attend daycare centers and to compare between semi-urban and rural.~To describe the inter and intra-individual variation of the hydration status in preschool children, with a similar diet, who attend daycare centers and to compare between semi-urban and rural.~To explore intra-individual associations in variables of the same research component or different component variables.
Inclusion criteria: inclusion criteria:

 To be attending one of the SOSEP systems assigned daycare centers

 To maintain an attendance of 80% during the 8 weeks of the fieldwork

 Aged 23 to 84 months

 Being apparently healthy and with no dietary restrictions related to the foods offered with the SOSEP menu.

Exclusion criteria: :

 Children whose parents of caregivers did not sign a consent form

 Children who refused to participate in the study

 Children who refused to adhere to the collections routines.


Human Papillomavirus (HPV) and Risk of Cervical Precancer and Cancer

Summary: Background:~In most women, HPV infection does not cause symptoms and the infection goes away on its own. In a small percentage of women, the HPV infection does not go away and sometimes can result in cervical precancer or cancer.~There are several different types of HPV. A better understanding of which types are related to cervical precancer and cancer may help guide doctors in clinical management of women who test positive for HPV and better understand why some women develop disease while others do not.~Objectives:~To determine whether certain types of HPV are more risky than others and if so, whether they warrant separate detection in screening for cervical precancer and cancer.~To determine if lasting infection by different HPV types carry different risk of cervical precancer and cancer.~To determine what viral and genetic factors influence the development of cervical precancer and cancer.~To evaluate new HPV tests and new biomarkers of cervical cancer risk.~Eligibility:~-Women 30 years of age and older who are in the cervical cancer screening program at the Kaiser Permanente health plan in Northern California. Women who tested positive for HPV and a random sample of women who tested negative for the virus are included.~Design:~-Data about participants genetic background and the type of carcinogenic HPV with which they are infected are analyzed.
Inclusion criteria: inclusion criteria:

 Women in KPNC aged 25 years or older who tested positive for HPV.

 Will also include a random sample of women who tested negative for HPV.

Exclusion criteria: :

 Male.

 Children under 18.


AngioSeal Versus Radial Approach in Acute Coronary Syndrome

Summary: Among non-ST-segment elevation acute coronary syndrome patients submitted to early invasive strategy and randomized for the transfemoral or transradial approach, the AngioSeal vascular closure device would decrease the prevalence of vascular complications at puncture site, reaching the non-inferiority criterion when compared to the radial access.
Inclusion criteria: inclusion criteria:

 Non-ST-segment elevation ACS patients [ischemic symptoms suspicious of non-ST-segment elevation ACS (unstable angina or non-ST-segment elevation AMI) defined as clinical presentation compatible with a new manifestation of worsening of chest pain characteristic of ischemia, at rest or at minimum effort, lasting more than 10 minutes, and at least one of the following items: (a) ECG changes compatible with new ischemia (ST segment depression of at least 1 mm, or transient ST segment elevation, or ST segment elevation ≤ 1 mm, or T wave inversion > 2 mm in at least 2 contiguous shunts); (b) cardiac enzymes (CK-MB or troponin T or I) above the upper normality range limit; (c) patients > 60 years of age without ECG or myocardial necrosis markers changes, however with previous documentation of coronary atherosclerotic disease (CAD), confirmed by previous hospitalization due to AMI, previous percutaneous or surgical myocardial revascularization procedure, significant CAD confirmed by coronary angiography, or positive functional test for myocardial ischemia];

 Intention to submit patient to early invasive strategy consisting of coronary angiography immediately followed by PCI, when applicable, in the first 72 hours after admission;

 Signed informed consent;

 Patient eligible for transradial and transfemoral coronary angiography and PCI, being pre-requisites: (a) palpable radial artery with normal Allen test or/and oximetry tests, (b) familiarity of the operator with the radial and femoral techniques using AngioSeal, (c) agreement of the operator to use the access route determined by the randomization process.

Exclusion criteria: :

 Less than 18 years of age;

 Pregnancy;

 Chronic use of vitamin K antagonists or direct thrombin inhibitors, or oral Xa-factor antagonists;

 Hypersensitivity to antiplatelet and/or anticoagulant drugs;

 Active bleeding or high bleeding risk (severe liver failure, active peptic ulcer, creatinine clearance < 30 mL/min, platelets count < 100.000 mm3);

 Uncontrolled systemic hypertension;

 Cardiogenic shock;

 Previous myocardial revascularization surgery with ≥ 1 internal mammary or radial artery graft;

 Documented chronic peripheral arterial disease preventing the use of the femoral technique;

 Severe concomitant disease with life expectancy below 12 months;

 Participation in drug or devices investigative clinical trials in the last 30 days;

 Indication of elective percutaneous coronary intervention to be performed in a moment different from immediately after coronary angiography;

 Medical, geographic or social conditions impairing the participation in the study or inability to understand and sign the informed consent term.


Efficacy of Tailored Cognitive-Behavioral Therapy for Chronic Back Pain

Summary: This clinical trial compares two psychological treatments for back pain.
Inclusion criteria: inclusion criteria:

 Chronic back pain for at least 6 months

 Treatment by medication or physical therapy

Exclusion criteria: :

 Acute or life threatening physical illness

 Current alcohol or substance abuse or dependence

 Current psychosis or suicidal ideation treatment by anesthesiology, chiropractic care or surgery

['tailored cognitive behavior therapy', 'standard care']

tailored cognitive behavior therapy
standard care


NexGen EBA Radiologic and Immunologic Biomarkers of Sterilizing Drug Activity in Tuberculosis

Summary: Background:~- Tuberculosis (TB) is a lung infection caused by bacteria. When people with TB cough, they may spread these bacteria. Researchers are looking for new TB medicines. They want to find a faster way to tell if a drug might combat TB.~Objective:~- To learn the effect of different anti-TB drugs on microbiological, radiographic and immunologic markers in people with TB.~Eligibility:~- Adults age 18-65 who weigh 30-90 kg and have common TB bacteria that can be treated with common TB medicines.~Design:~Participants will be admitted to the hospital for screening. They will have medical history, physical exam, and chest radiograph. They will give blood, urine, and sputum samples.~Participants will be put in 1 of 8 groups.~Participants will get one or a combination of TB medicines daily for about 14 days.~Each day, participants:~Will discuss side effects.~May have a physical exam.~Will spit mucus into a cup. They may breathe in saline water through a nebulizer to make them cough.~Participants will have blood taken 3-4 times during the study~Participants will have 2-3 Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG-PET/CT) scans. FDG is a radioactive sugar molecule which helps measure TB disease in the lungs. It will be injected into a vein. Participants will lie in a scanner that takes pictures.~Around study day 14, participants will leave the hospital. They will be referred to a local TB clinic. There they will get the standard 4 TB medicines. Those in group 8 will already be on these medicines and will have another FDG-PET/CT on day 28.~Participants will be in the study for up to 28 days.
Inclusion criteria: inclusion criteria:

 Age 18 to 65 years with body weight from 30 kg to 90 kg

 Sputum acid-fast bacilli (AFB) smear positive (at least 1+ on the WHO International Union Against Tuberculosis and Lung Disease scale)

 Likely able to produce approximately 10 mL of sputum per day

 Xpert MTB/RIF-confirmed M.tb

 Rifampin-sensitive pulmonary tuberculosis as indicated by Xpert MTB/RIF

 ALT <3X upper limit of normal, creatinine <2X upper limit of normal

 Willingness to have samples stored

Exclusion criteria: :

 Clinically suspected disseminated TB or acuity of illness too much as deemed by clinicians

 Has been treated for tuberculosis within the past 3 years

 Treatment with agents known to have anti-tuberculosis activity (e.g., fluoroquinolones, linezolid) for any indications during the current episode of clinical illness or within 2 months prior to screening, whichever is longer

 Cirrhosis or chronic kidney disease

 Disease complications or concomitant illness that might compromise safety or the interpretation of trial endpoints, such as known diagnosis of chronic inflammatory condition (e.g., sarcoidosis, rheumatoid arthritis, and connective tissue disorder)

 Use of immunosuppressive medications, such as TNF-alpha inhibitors or systemic or inhaled corticosteroids, within 2 weeks prior to screening

 Subjects with diabetes, point of care HbA1c above 6.5, or random glucose over 200 mg/dL

 Conditions which compromise the subject s ability to take or absorb oral drugs

 Normal PA-Chest radiograph, determined during screening

 Total lung (left or right) collapse on PA-Chest radiograph

 HIV positive

 Pregnant or breastfeeding

 Any other condition that, in the responsible clinician s judgment, renders a subject too sick to safely tolerate 2 weeks study therapy

 Any condition that constitutes a contraindication to any of the drugs to be used on any study arms

['Treatment', 'PET/CT Scan', 'Sample Collection']


Observational Non-interventional Study (Anwendungsbeobachtung) With Telmisartan in High-risk Hypertensives

Summary: This observational non-interventional study will assess (under conditions of clinical practice in daily routine) the antihypertensive efficacy of telmisartan treatment with or without active promotion of lifestyle changes in hypertensive patients at high cardiovascular risk
Inclusion criteria: inclusion criteria:

 patients with essential hypertension aged >/= 18 years with one of the following risk factors: history of coronary artery disease or stroke/TIA or peripheral artery disease or diabetes mellitus.

Exclusion criteria: :

 according to SPC


Effect of a Cannabinoid Agonist on Colonic Sensory Functions in Patients With Irritable Bowel Syndrome

Summary: Irritable bowel syndrome (IBS) affects about 15% of the U.S. population. There are still no effective and safe medications approved for the treatment of abdominal pain associated with bowel symptoms in IBS. This study will investigate the effects of an approved medication, Dronabinol, on the movement of food through the stomach and colon in subjects with a history of diarrhea-predominant Irritable Bowel Syndrome (D-IBS).
Inclusion criteria: inclusion criteria:

 Age 18-75 years

 Positive for IBS symptoms by Rome III criteria

 No prior abdominal surgery (except appendectomy or cholecystectomy

 Score of 10 or less on either Anxiety or Depression on the Hospital Anxiety/Depression Inventory

Exclusion criteria: :

 Patients with significant depression (score of greater than 10 on Hospital Depression Inventory

 Patients with anxiety (score of greater than 10 on Hospital Anxiety Inventory. However, patients on stable doses of selective serotonin inhibitors (SSRIs) or low dose of tricyclic antidepressants will be eligible.


Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass

Summary: Randomized controlled trial of the use of glucocorticoids to improve the clinical course of neonates post-cardiopulmonary bypass (CPB).
Inclusion criteria: inclusion criteria:

 Neonates Age </= 1 month

 Scheduled to undergo cardiac surgery involving Cardiopulmonary Bypass (CPB) (reparative or palliative procedures)

 Inpatient Status at MUSC a minimum of 8 hours prior to planned surgery

Exclusion criteria: :

 Prematurity: </= 36 weeks post gestational age at time of surgery

 Treatment with steroids, other than inhaled forms, in the two weeks prior to scheduled surgery

 Participation in research studies involving the evaluation of investigational drugs within 30 days of randomization

 Suspected infection that would contraindicate steroid use (eg - Herpes)

 Known hypersensitivity to IVMP or one of its components or other contraindication to steroid therapy (e.g., gastrointestinal bleeding)

 Preoperative use of mechanical circulatory support or active resuscitation at the time of proposed randomization

 Inability to begin the pre-operative study drug at least 8 hours prior to surgery

['methylprednisolone (IVMP)', 'methylprednisolone (two doses IVMP)']

methylprednisolone (IVMP)
methylprednisolone (two doses IVMP)

['Congenital Heart Disease', 'Disorder of Fetus or Newborn']

Congenital Heart Disease
Disorder of Fetus or Newborn


Ankle Manual Therapy for Ankle Sprains

Summary: The purpose of this study is to determine the effect of using ankle manual therapy procedures on clinical outcomes in individuals with post-acute ankle sprains.
Inclusion criteria: inclusion criteria:

 Age 16-60 years

 Onset of ankle sprain at least 2 weeks prior to enrollment

 Foot and Ankle Ability Measure Activity of Daily Living subscale score less than or equal to 80%

Exclusion criteria: :

 Current status of assisted ambulation (eg, use of cane or crutches)

 Inability to bear weight through the affected extremity immediately after injury combined with tenderness to palpation of the medial and lateral malleolar zones, styloid process of the 5th metatarsal, and navicular

 Positive anterior drawer or talar tilt dimple test

 Volume of the affected limb greater than 10% of the unaffected limb

 Previous history of ligament or bony reconstructive surgery to the ankle and foot

 Concomitant injury to other lower extremity joints

['Passive Positioning', 'High-Velocity, Low-Amplitude Stretch', 'Slow, Mobilization Stretch']

Passive Positioning
High-Velocity
Low-Amplitude Stretch
Slow
Mobilization Stretch


Optimising Congestive Heart Failure Outpatient Clinic Project

Summary: This study examines whether a nurse monitored management program at the hospital heart failure outpatient clinic can improve quality of life in elderly patients with chronic heart failure, as compared to standard treatment in primary healthcare.
Inclusion criteria: inclusion criteria:

 Patients 60 years of age or older

 Hospitalized with heart failure according to New York Heart Association (NYHA) class II-IV

 Left ventricular systolic dysfunction with an ejection fraction below 0.45, by echocardiography

Exclusion criteria: :

 An acute myocardial infarction or unstable angina pectoris within the last three months

 Valvular stenosis

 Dementia

 Severe concomitant disease

 Refusal to participate.

['Nurse monitored heart failure program', 'Standard primary health care']

Nurse monitored heart failure program
Standard primary health care


NO Donors and Inhibitors to Study Imbalance of Nitrogen Stress and Antioxidant Defense in COPD

Summary: The primary aim of this study is to investigate the effects of oral and inhaled administration of L-arginine and of inhaled aminoguanidine on bronchial and alveolar exhaled NO and NO metabolites in exhaled breath condensate, induced sputum, nasal lavage and mouth wash fluid in healthy non-smokers, current smokers and patients with COPD.
Inclusion criteria: inclusion criteria:

 Healthy non-smokers

 Normal spirometry (FEV1 >90 % predicted; exhaled NO bigger than or equal to 10 ppb; flow 50 ml/s)

 At risk (current smokers)

 Normal spirometry, with or without chronic symptoms (cough, sputum production)

 FEV1 reversibility of <15% after inhaled beta2-agonists*

 Moderate COPD

 FEV1 greater than or equal to 30% and < 80%

 FEV1/FVC < 70% predicted

 FEV1 reversibility of <15% after inhaled beta2-agonists

 With or without chronic symptoms (cough, sputum production, dyspnea)

 Able to comprehend and grant a written informed consent

Exclusion criteria: :

 Concomitant use or pre-treatment within the last 4 weeks with oral steroids

 Respiratory infection within 4 weeks prior to entry into the trial

 Females who are pregnant or lactating

 History of current or past drug or alcohol abuse

['Chronic Obstructive Pulmonary Disease']


Improving Multivitamin Supplementation to Pregnant Women

Summary: The purpose of this study is to compare the tolerability of Pregvit® to a common prenatal vitamin (Orifer® F) among pregnant women with morning sickness or those suffering from a variety of conditions.
Inclusion criteria: inclusion criteria:

 Any woman who discontinued her standard vitamins due to gastrointestinal symptoms or due to the tablet size, with one ofthe following conditions:

 Morning sickness.

 Gastrointestinal disorders: Crohn's disease, ulcerative colitis, peptic or duodenal ulcer, irritable colon, celiac disease.

 Iron deficiency anemia.

 Hypothyroidism.

 Depression.

Exclusion criteria: :

 Women who do not agree to consent to this protocol.

 Women with a known hypersensitivity to any of the ingredients of Pregvit®, or Orifer® F.

['Pregnancy', 'Morning Sickness', 'Nausea', 'Vomiting', 'Hyperemesis Gravidarum']

Pregnancy
Morning Sickness
Nausea
Vomiting
Hyperemesis Gravidarum


Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients

Summary: This study seeks to assess whether coma patients really benefit from the use of antibiotics as a prophylactic for reducing the incidence of early ventilator-associated pneumonia in this population group. For this we consider the use of ampicillin sulbactam antibiotic which has a low ability to induce resistance, efficacy and safety observed during the time that has been used, even in patients with neurosurgical pathology, and to be broadly available in our environment.~Our hypothesis is that neurological patients in coma state, requiring mechanical ventilation, the application of antibiotic prophylaxis compared with placebo reduces the incidence of early ventilator-associated pneumonia.
Inclusion criteria: inclusion criteria:

 All patients admitted to intensive care units,with score in the Glasgow Coma scale less than nine.

 Requiring mechanical ventilation for more than 48 hours

 Includes all patients with structural or metabolic coma

Exclusion criteria: :

 Pregnant women

 History of allergic reactions to ampicillin sulbactam

 Patients admitted as potential organ donors

 Patients with an indication of antibiotic therapy, or who have received more than 2 doses of any antibiotic previously.

 Hospital stay for more than 48 hours before intubation.


Impact of CT on Diagnosis of Acute Appendicitis

Summary: The purpose of this study is to determine whether computed tomography is reliable investigation in the diagnosis of acute appendicitis.
Inclusion criteria: inclusion criteria:

 Patients who have been admitted and diagnosed as having acute appendicitis

Exclusion criteria: :

 Patients under the age of 18 years.

 Pregnancy.

 Uncooperative patients (senile dementia, mentally ill).

 Not speaking Danish.

 Does not wish to participate.


Sildenafil Trial in Children and Young Adults With CF

Summary: Cystic Fibrosis (CF), the most common inherited disease in Caucasians, is characterized by chronic pulmonary inflammation and progressive loss of gas exchange units that eventually results in respiratory failure. There is strong evidence that, in CF, abnormally low perfusion carries a high risk of death independent from the presence of pulmonary hypertension. However, the evolution of pulmonary vascular disease in CF and how it might contribute to the rate of decline in lung function is not known. Our knowledge remains limited to the results of old observational studies which concluded that the major causes of pulmonary vascular remodeling and hypertension in CF are hypoxic respiratory failure and destruction of lung tissue. Our recent data obtained by state-of-the-art Magnetic Resonance Imaging (MRI) of the pulmonary circulation, challenges the existing paradigm. We demonstrate that in the absence of hypoxia, significant changes in pulmonary perfusion and in surrogate measures of vascular resistance as well as in collateral blood flow begin early in the course of CF. Newly developed therapeutics have altered dramatically the course of patients suffering from pulmonary vascular disease. Through this 8 week trial, we will examine by Magnetic Resonance Imaging the effect of Sildenafil on pulmonary perfusion and systemic vascularization of the lungs in subjects with mild to moderate disease.
Inclusion criteria: inclusion criteria

 Research subjects must meet the following inclusion criteria:

 Age 8 years to age 21 years

 Weight > 20kg

 Diagnosis of cystic fibrosis confirmed by a prior sweat chloride evaluation of > 60 mmol/liter or by two identified CFTR mutations on genetic analysis

 Able to perform acceptable and repeatable spirometry per American Thoracic Society/European Respiratory Society (ATS/ERS) joint consensus criteria.

 Have valid spirometry data for at least 3 years

 Must have mild to moderate lung disease (Mild lung disease will be defined as an FEV1%p of 80-99% predicted. Moderate lung disease will be defined as an FEV1%p of 60-79% predicted.)

 If under the age of 18, the subject must assent to participation in the study, and the subject's parent or guardian must be able to give written informed consent and comply with the requirements of the study protocol

 If 18 years of age or older, the subject must be able to give written parental permission and comply with the requirements of the study protocol

 For female subjects: negative serum pregnancy test and must be willing to use contraception during study participation

 Able to tolerate MRI without sedation

 Subjects who are on alternating monthly on/off cycles of inhaled antibiotics must be willing to be off of inhaled antibiotic therapy for one on cycle.

 Must be currently enrolled in CCHMC IRB#: 2008-0926

 Normal Vitamin K status (PT/IND, PIVKA, etc) at screening

Exclusion criteria:

 Research subjects will be excluded from the study based on:

 History of CF-related liver disease with portal hypertension

 Currently smoking cigarettes or other tobacco products

 Use of daytime oxygen supplementation

 Previous organ transplantation

 Unstable or uncontrolled hypertension

 Ongoing use of oral corticosteroids

 For female subjects: pregnancy or lactation and unwillingness to use contraception during study participation

 Any hemodynamically significant congenital or acquired cardiac disease or significant cardiomyopathy, hematologic disease (i.e. hemoglobinopathies), or pulmonary disease associated with an increased risk of pulmonary perfusion defects or pulmonary hypertension other than as an outcome of CF

 History of renal and/or hepatic insufficiency, defined as cystatin-C level that exceeds normal range and a previous diagnosis of liver cirrhosis.

 History of uncontrolled asthma defined as oral steroid dependent

 History of hypersensitivity to gadolinium (Magnevist)

 Contraindications specific to MRI including a history of claustrophobia, cardiac pacemaker, or other non-MRI compatible surgical implants (This includes neuro-stimulators containing electrical circuitry, or which generate electrical signals and/or have moving metal parts, and metal orthopedic pins or plates. The research coordinator and/or the MRI technologist will screen all subjects using the standard checklist of medical history and safety questions used by the Radiology Department in routine clinical scans.)

 Daily use of montelukast and ibuprofen

 Use of nitrate medicines or other drugs known to have unsafe interactions with Sildenafil

 Known allergy to Sildenafil

 Inability to comply with study procedures

 History of the following:

 Tinnitus or hearing impairment

 CF exacerbation within the preceding two months

 Ulcer, severe gastritis, or prior GI bleed

 Recurrent epistaxis

 Diabetes or abnormal OGTT (risk of retinal hemorrhage with sildenafil is highest in diabetics)

 Laboratory

['Cystic Fibrosis With Mild to Moderate Lung Disease', 'CMRI of Lung Perfusion', 'Lung Perfusion', 'Lung Vascularization']


Patent Foramen Ovale in Cryptogenic Stroke Study

Summary: The study sought to assess the rate of recurrent stroke and death in stroke patients with a patent foramen ovale randomized to treatment with warfarin or aspirin. This was a multicenter study conducted at 48 U.S. Institutions.
Inclusion criteria: inclusion criteria:

 Age 30-85

 Ischemic stroke within 30 days

 Glasgow outcome scale ≥ 3

 No contraindications to warfarin/aspirin

Exclusion criteria: :

 Basal INR > 1.4

 Post-procedural stroke

 Severe carotid atherosclerosis

 Cardioembolic stroke

 Contraindications to transesophageal echocardiography

['Ischemic Stroke', 'Patent Foramen Ovale']


Analysis of the Time Taken to Triple Therapy (NOVARTIS)

Summary: The proposed study will evaluate (for newly diagnosed Chronic Obstructive Pulmonary Disease (COPD) patients)the time taken to prescription of triple therapy by aiming to answer these following research questions:~The percentage of patients prescribed triple therapy, and when they first started receiving triple therapy.~For patients prescribed triple therapy, the time taken to triple therapy from initial diagnosis of COPD.~The variation in treatment pathways.~The factors associated with time taken to triple therapy.
Inclusion criteria: inclusion criteria:

 Aged ≥40 years at initial date of COPD diagnosis

 COPD diagnosis with Quality Outcome Framework (QoF) approved read code

 has spirometry data supportive of a COPD diagnosis in the 5 years around initial date diagnosis of COPD (FEV1 % predicted)

 Patient has one year of data prior to initial date of COPD diagnosis

 Patient has a minimum of two years of data post initial date of COPD diagnosi

Exclusion criteria: :

 Patients whose initial date of COPD diagnosis is before 1997


Relative Efficacy of Two Regimens of Ante-helminthic Treatment

Summary: The most common soil transmitted helminthic infections(STHI) includes infection with Ascaris lumbricoides, Trichuris trichiura, and Hookworm. Growth retardation, malnutrition, anemia, impaired cognitive function and immunosuppression are main manifestations in children. Even within the developing world, wide differences exist in prevalence rates. The poorest countries have higher levels of STHI than those with a lower incidence of poverty. According to an estimate made by the WHO, the prevalence of A. lumbricoides, T. trichiura and Hookworm in South Asia was 27%, 20% and 16% respectively. Given that the prevalence of STHI in urban slums in Bangladesh is much higher than the other parts of the world and Asia and that there are major health and socio-economic consequences of such infections, it is important that we come up with effective means of reducing the prevalence of such infections. 60-80% of preschool children in urban slums of Bangladesh are infected with these STHI due to poor hygiene . At present deworming at six months interval is recommended but the effectiveness of this regimen of dewormig is questionable.~2. Hypothesis: Ante-helminthic treatment at every three month is more effective than ante-helminthic treatment at every six months to reduce soil transmitted helminthic infection, to reduce diarrheal and respiratory illness to improve nutritional status in preschool children.~3.Objective: The main objectives of the proposed study is to compare the relative efficacy of two different ante-helminthic treatment regimens to reduce the prevalence of STHI, diarrheal diseases, respiratory illness and to improve nutritional status in children 4. Design: The population of the study will be preschool children aged 2-5 year and will be selected randomly from an urban of Dhaka. They will be divided into two groups randomly. One group will get ante-helminthic at every three months interval and the other groups will get at six months interval for one year. Stool samples will be collected at the baseline and after three months completing one-year treatment of the above mentioned regimen. Blood haemoglobulin and nutritional status will also be measured at baseline and after three months of completion of treatment as mentioned above. The treatment will be 400 mg of Albendazole in a single dose.~5. Potential Impact: The findings of the research can be implemented by the government and non-government organization.
Inclusion criteria: inclusion criteria:The inclusion criteria are;

 age of the child is 2-5 years old,

 he/she has not been suffering from serious chronic illness,

 the child stool test must be positive for STH,

 he/she had not been taken any antehelminthic drug in the previous six months,

 parents/guardian are agree for their child participation in the study. e -

Exclusion criteria: :

 age of the child less than 2 years old and more than 5 years old,

 his/her stool test negative for any intestinal helminth,

 he/she has been suffering from serious chronic illness,

 parents/guardian are not willing to give consent for their child's participation in the study,

 if he/she receives any antehelminthic drug after survey but before the study interventions.


A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis

Summary: The objectives of this study are: to confirm the superiority of TAU-284 over placebo after two weeks of administration to pediatric patients with perennial allergic rhinitis, and to investigate the dose response, safety, and plasma concentrations of TAU-284.
Inclusion criteria: inclusion criteria:

 Patients aged between 7 and 15 years

 Patients with a weight of at least 20 kg

 Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria

 Patients with a mean rhinorrhea score of at least 2 and a mean total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion] of at least 4 on the basis of symptoms recorded in the nasal allergy diary during the observation period

Exclusion criteria: :

 Patients with vasomotor rhinitis or eosinophilic rhinitis

 Patients who have concurrent nasal disease that may affect the efficacy of TAU-284

 Patients with a history of any of the nasal surgical procedures

 Patients who have a positive result for pollen antigens which are dispersed during the study period

 Patients who have a positive result for dog dander or cat dander antigen

 Patients with current or previous history of drug allergy

 Patients who concurrently have renal function abnormalities that may cause safety problems