Safety and Immunogenicity of Single Dose Choleragarde® in HIV-Seropositive Adults

Summary: The purpose of this study is to assess the safety and immunogenicity of Peru-15 (CholeraGarde®) vaccine in HIV seropositive adult population of Bangkok Thailand
Inclusion criteria: inclusion criteria:

 HIV-seropositive, non-pregnant adults, aged 18 - 45 years old who have been on standard highly active antiretroviral therapy (HAART) for at least 6 months prior to enrollment or who have never started HAART regimen will be recruited in the study.

 All subjects must satisfy the following criteria at study entry:

 Male and female HIV seropositive adults aged 18 to 45 years old who have given the written informed consent.

 Will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection).

 CD4 T-lymphocyte count >500/mm3 for at least 6 months prior to inclusion

 Subjects that have never started HAART regimen must satisfy the following additional criteria at study entry.

 1. Asymptomatic HIV infection as determined by: Medical history, Physical examination, Laboratory tests, Clinical judgment of the investigator

 Subjects that have been on standard highly active antiretroviral therapy (HAART) for at least 6 months prior to enrollment must satisfy the following additional criteria at study entry.

 History of CD4 nadir >150/mm3

 Viral load (HIV-1 RNA levels) <200 copies/mL for at least 6 months prior to inclusion

Exclusion criteria: :

 The following criteria should be checked at the time of study entry, if any of the following is present then the subject will be excluded from the study:

 Overt signs of immunodeficiency e.g. oral thrush, rapid weight loss, recurrent pneumonia (i.e. Stage 3 or 4 of the WHO clinical staging system for HIV infection and disease in adults and adolescents

 Ongoing serious chronic illness (e.g. with signs of cardiac or renal failure)

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

 Presence of V. cholerae 01 or 0139, Shigella, or Cryptosporidium in stool at baseline

 Intake of any anti-diarrhoeal medicine in the past week

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

 Receipt of antibiotics in the past 2 weeks

 Receipt of live or killed enteric vaccine in the last 4 weeks

 Receipt of killed oral cholera vaccine in the past

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

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

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

 Receipt of blood, blood products or a parenteral immunoglobulin preparation in the previous 6 months

 Receipt of any immunosuppressive therapy during the past 6 months

 A woman pregnant or planning to become pregnant during the period of subject's participation

 Any condition which in the opinion of the investigator, might interfere with the evaluation of the study objectives

['Cholera', 'Vibrio Infections', 'Diarrhea']


Crossover Study With the ProSeal and Supreme Laryngeal Mask Airway

Summary: The LMA Supreme is a new extraglottic airway device which brings together features of the LMA ProSeal, Fastrach and Unique. We test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the LMA ProSeal and the LMA Supreme in paralyzed anesthetized patients
Inclusion criteria: inclusion criteria:

 American Society of Anesthesiology physical status grade I-II

 Age 18-80 yr

 Elective gynecological surgery

 Supine position

Exclusion criteria: :

 Known or predicted difficult airway

 Body mass index >35 kg m-2

 Risk of aspiration


An Open Cohort of Childhood Tuberculosis in Mbarara National Referral Hospital, Uganda

Summary: The aims at investigating how the diagnosis of Tuberculosis in children in a setting of high TB and HIV prevalence can be improved and to assess the treatment outcomes and tolerance of the new WHO recommended TB drug dosages.
Inclusion criteria: inclusion criteria:

 Any child with at least one of the following criteria:

 Unexplained weight loss or documented failure to thrive or stagnant weight or Growth faltering on the growth charts over the past 3 months despite adequate nutrition and deworming,

 Non - remittent cough or wheeze for more than 2 weeks,

 Night sweats persistent or intermittent during the last 2 weeks

 Prolonged fever (temperature > 38°C) for 7 days, after common causes such malaria or pneumonia has been excluded.

 Wheeze/Stridor - persistent, non remitting during the last 2 weeks

 Chest pain - Persistent, localized, pleuritic in nature during the last 2 weeks

 Unexplained fatigue, weakness, apathy, lethargy or reduced playfulness during the last 2 weeks

 Painless superficial lymph node mass (>2x2cm)-

 Chronic onset meningitis (>5days), lymphocytic predominance in CSF or meningitis not responding to antibiotic treatment (ref 8)

 Recent gibbus

 Abdominal distention with ascites OR

 Any child with an abnormal chest X-ray (CXR) suggestive of TB (hilar/paratracheal adenopathy with/without airway compression, airspace opacification not responding to antibiotics or documented TB contact, lung cavities or miliary infiltrates) OR

 Asymptomatic child with a history of recent contact (within past year) with a pulmonary TB smear or culture positive patient and an abnormal chest X-ray AND

 Informed Consent signed by parent or legal representative

Exclusion criteria: :

 Current TB treatment (patient who received < 3 days of treatment or patients receiving IPT could be still included) or TB treatment completed within the past 6 months.

 Absence of informed consent

 Living outside of Greater Mbarara region.

 Unable or unwilling to attend to the follow-up visits


Brain Tissue Swelling and Seizure Activity in Inactive Cysticercosis

Summary: This study will examine what causes seizures in patients with cysticercosis (pork tapeworm infection). A better understanding of this could lead to improved methods of controlling or preventing seizures.~In humans, the pork tapeworm (Taenia solium) lives in the small intestine. The parasite's microscopic eggs travel around the body-including to the brain-where they develop into cysts. Usually, the cysts don't cause symptoms until they die. Then, they provoke an inflammatory reaction that irritates the brain, causing seizures and other symptoms. The inflammation eventually goes away, but the dead cysts remain. Calcium deposits often form where the cysts are. Some of the calcified cysts develop swelling around them that seem to be associated with the development of seizures.~This study will explore how and why these dead, calcified cysts continue to cause seizures. In so doing, it will try to determine: 1) the best diagnostic imaging method for detecting swelling around the cysts; 2) how often swelling occurs; and 3) what makes some cysts prone to swelling and related seizure activity, while others are not.~Patients with cysticercosis who have had seizures or who have known or possible swelling around calcified cysts will be studied with various tests, including magnetic resonance imaging (MRI), computed tomography (CT) scans, electroencephalography (EEG), blood tests, and possibly lumbar puncture. Patients will be studied for two cycles of seizures (during active and quiet periods) or a maximum 4 years.
Inclusion criteria: inclusion criteria:

 18 years of age or older. If children are evaluated they can be seen under the general protocol and they may be entered into the present protocol under an exception.

 Likely diagnosis of inactive cysticercosis and present or past seizure activity. Requires a and b plus any one of the remaining criteria:

 History of seizures or present seizure activity;

 Previously treated or has inactive disease and declines treatment;

 Single calcified lesions and positive serology;

 Multiple calcified lesions;

 Multiple small enhancing nodular lesions;

 History of cystic lesions responding to specific chemotherapy.

 If female, not pregnant and using effective birth control methods.

Exclusion criteria: :

 Less than 18 years of age.

 Pregnant or unwilling to use effective birth control measures.

 Refuse blood tests.

 Unwilling or unable to undergo testing according to the schedule.

 Unable to undergo MRI or CT examinations.

 Patients who require anesthesia to undergo imaging studies.


DEPITAC : Short Screening Scale for Psychotraumatic Disorders After Motor Vehicle Accident

Summary: Posttraumatic stress disorder (PTSD) is a serious and often chronic response to overwhelmingly stressful events as Road Traffic Accident. Moreover PTSD is associated with increased rates of medical morbidity, poor health-related quality of life, and functional impairment. PTSD is prevalent in primary care settings after road traffic accident, where approximately 25% of patients meet diagnostic criteria for the disorder. Despite the development of a number of efficacious behavioral and pharmacological treatments, only a minority of patients with PTSD receive mental health services. PTSD is frequently underrecognized and untreated in Emergency Department and Surgical Unit.~Then, early diagnosis and prevention of PTSD might help to identify patients with PTSD high risk and lead them to benefit of personalized cares. Nevertheless it is not possible (neither useful) to provide psychological cares for each road traffic accident victim.~This is the reason why we think that nurses can help to screen patients who need treatment for PTSD Hypothesis : Recognition of specific clinical or biological signs occurring during road traffic accident victim hospitalization in surgical unit could allow beginning specific treatment using consultation liaison psychiatry.~Early treatment could allow decreasing incidence of psychotraumatic disorders, increasing surgical functional efficacy and improve convalescence programs. The use of a specific questionnaire could help to screen this disorder.~We have created the DEPITAC scale : a short screening questionnaire with 10 items.~This study will be evaluated DEPITAC's 10-item screen for posttraumatic stress disorder (PTSD) for use in surgical or emergency department.
Inclusion criteria: inclusion criteria:

 Road traffic accident victims hospitalized in surgical department less than 2 weeks

 Can be called by phone

Exclusion criteria: :

 Patient with a coma for more than 15 minutes

 Patient with a crania traumatism and with loss of consciousness over 15 minutes

 Homeless

['Stress Disorders, Post-Traumatic', 'Stress Disorders, Traumatic, Acute']

Stress Disorders
Post-Traumatic
Stress Disorders
Traumatic
Acute


International Normalized Ratio (INR) Normalization in Coumadin Associated Intracerebral Haemorrhage

Summary: Intracerebral haemorrhage (ICH) is the most feared complication in patients on vitamin K antagonists (VKA). VKA related ICH occurs 8-10 times more frequently and the mortality is 2 times higher than in non-anticoagulated patients. Mortality may rise up to 67%. The higher mortality rate may in part be due to the higher rate of haematoma expansion (HE) over a longer period after symptom onset. International guidelines recommend treatment of VKA-ICH with prothrombin complex (PCC) or fresh-frozen plasma (FFP) both in combination with Vitamin-K. But these recommendations are not based on randomized controlled trials. It is known that these drugs lower the INR, and thus it is assumed that normalization of coagulopathy may lead to haemostasis and reduction of HE. Safety and efficacy of these treatments have never been studied in a prospective controlled trial.~The investigators' questions are: How potent are PCC and FFP in normalization of the INR? What is the safety profile of each of these drugs?
Inclusion criteria: inclusion criteria:

 Spontaneous ICH (intraparenchymal), subdural hematoma (SDH) diagnosed by CT scanning ≤ 12 hours after onset of symptoms. In case of unknown time of symptom onset: time between last seen in healthy condition and first CCT ≤ 12 hours.

 Therapy receiving vitamin K antagonists (VKA)

 International Normalized Ratio (INR) ≥ 2

 Signed informed consent form, or signed informed consent by a legal representative, judicial consent in cases where no legal representative is available in time, or consent of an independent physician familiar with the indication in cases where the first three possibilities can not be realized.

Exclusion criteria: :

 Patients with ICH not related to vitamin-K antagonist therapy or

 Patients with secondary ICH related to infarction, hemophilia or other coagulopathy, tumor, hemorrhagic infarction, cerebrovenous thrombosis, aneurysm, arteriovenous malformations (AVM) or severe trauma

 Deep Coma (GCS ≤ 5) at the time of admission or before intubation if intubated outside the hospital

 Known previous disability (mRS > 2 before stroke occurred)

 Acute myocardial ischemia, acute septicemia, acute crush injury, any history of acute hemorrhagic disseminated intravascular coagulation, acute thrombotic stroke

 Known history of intermittent claudication

 Known recent thrombotic event < 30 days

 Acute or known congestive heart failure (NYHA III, IV)

 Pulmonary edema

 Known liver failure (child-pugh-score C)

 Known alcohol or other drug abuse

 Known active malignant disease

 Known thrombocytopenia (platelets <50,000/µL), hemorrhagic diathesis (primary defects of coagulation, fibrinolysis, platelets)

 History of hypersensitivity to the investigational products or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational product

 Known allergy to heparin or history of heparin induced thrombocytopenia.

 Pregnancy and lactation

 Concomitant use of antithrombotic (with PTT > 1.5 of normal PTT), thrombolytic treatment.

 Use of aspirin, clopidogrel or dipyridamole or combinations thereof (e.g. Aggrenox®) is not an exclusion criterion. These drugs should be discontinued and not restarted earlier than 24 hours after normalization of INR if indicated.

 Previous participation in this trial

['Prothrombin complex concentrate (PCC); fresh frozen plasma (FFP)']


Continuous Video- EEG Monitoring in the Acute Phase in Patients With a Cerebrovascular Attack- Randomisation of a Subpopulation Regarding Treatment Strategy

Summary: Stroke is a major cause of epilepsy. The pathophysiological mechanisms of poststroke epilepsy are not known. Subclinical epileptiform discharges could contribute to the neuronal damage and influence functional outcome. Electro-encefalography (EEG) is the golden standard to detect interictal, ictal and subclinical epileptic brain activity.~Patients admitted to the stroke unit with an ischemic or hemorrhagic cerebrovascular attack will undergo a 24 hours video-EEG monitoring to detect epileptiform discharges. Clinical and paraclinical (imaging, serum markers of neuronal damage) parameters will be analysed together with the EEG results. The EEG results will be correlated with the occurence of epileptic seizures and functional outcome and mortality in the acute phase and in the long-term. When subclinical epileptic discharges are found on the EEG, patients will be asked to participate in a second part of the study where they will be randomised into a treatment (with an anti-epileptic drug) versus no-treatment group for a period of 6 months. Outcome parameters will be the occurrence of epileptic seizures, mortality and functional outcome.~Our main hypothesis is that the occurrence of subclinical epileptiform discharges during the acute phase following stroke influences functional outcome.
Inclusion criteria: inclusion criteria:

 Patients with ischemic arteria cerebri media infarct and spontaneous intraparenchymal bleeding

Exclusion criteria: :

 Patients with subarachnoidal haemorrhage, traumatic haemorrhage (epidural/subdural bleeding), cerebral venous sinus thrombosis, epilepsy, anti-epileptic treatment, transient ischemic attack, indication for urgent neurosurgical intervention

['starting of anti-epileptic drug treatment']


Open Versus Laparoscopic Appendectomy

Summary: The aim of this prospective randomized trial is to compare the feasibility of open with laparoscopic appendectomy in suspected acute appendicitis. The investigators especially focused on the postoperative recovery and long-term complications.
Inclusion criteria: inclusion criteria:

 age over 15 years

 suspected acute appendicitis

 suitability for laparoscopy

Exclusion criteria: :

 patients refusal to participate

 lack of a laparoscopic surgeon

['open appendectomy', 'laparoscopic appendectomy']

open appendectomy
laparoscopic appendectomy


Effect of Desipramine on Genioglossus Muscle Activity in Healthy Adults Study A

Summary: Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal participants. Until recently, the search for medicines to activate pharyngeal muscles in sleeping humans has been discouraging. However, exciting new animal research has shown that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle activity to waking levels. In this protocol the investigators will test the effect of desipramine (a tricyclic antidepressant with strong noradrenergic and antimuscarinic effects) on genioglossus muscle activity (EMG GG) during sleep in healthy control participants.
Inclusion criteria: inclusion criteria:

 Healthy control subjects

Exclusion criteria: :

 Cardiovascular disease other than well controlled hypertension

 Depression


A Longitudinal Multidimensional Population Study on Brain Aging

Summary: Longitudinal observational study of cognitive functions, physical health and biological parameters in the whole population living in Abbiategrasso born between 1935 and 1939,1773 subjects, followed for six years in order to know the prevalence and the incidence of dementia and risk and protective factors of normal and pathological mental aging.~The peculiarities of this study that must assure the outcome efficacy are:~Selected age: since 70-75 years old people represents a transition age from adulthood to old age, it is of special interest to study the evolution of psychic and physical functions of this population~Whole population not a sample study~Location: the small area involved (Abbiategrasso is a town of 30.000 inhabitants)can contribute to guarantee more homogeneity among the subjects and reduce undesired variability~multidimensional assessment(biological, clinical, social, psychological data collected) After initial screening, the recruited population will be followed up for two more times (every two years )
Inclusion criteria: inclusion criteria:

 to be resident in Abbiategrasso

 to be born between 1935 and 1939

Exclusion criteria: :

 to refuse to participate

 te be not contactable in any way (mail, telephone)

 to be legally resident, but actually living somewhere else

['Dementia', 'Alzheimer Disease', 'Vascular Dementia']

Dementia
Alzheimer Disease
Vascular Dementia


Cryptogenic Stroke Study

Summary: The purpose of this study is to determine whether the Sleuth Implantable Loop Recorder will enhance detection of latent atrial fibrillation in patients after cryptogenic stroke.
Inclusion criteria: inclusion criteria:

 Recent stroke (within 30 days) as defined by who has a sudden onset of focal neurological deficits presumed vascular etiology and lasting more than 24 hours.

 Negative brain image for hemorrhagic stroke

 In sinus rhythm at time of enrollment

Exclusion criteria: :

 Know history of atrial fibrillation

 Previous implanted cardiac device (ppM or ICD)

 Serious illness making it unlikely to survive one year

 Known secondary cause of stroke

['Sleuth AT Implantable ECG Monitoring System']


Development and Validation of a Quality of Life Instrument for Actinic Keratosis

Summary: Actinic keratoses (AKs) are some of the most common lesions seen by dermatologists. Flesh colored to erythematous, these lesions often present with scaling or crusting in sun damaged regions of the body. While they are physically visible and often palpable, these changes can also result in psychosocial changes in patients, including embarrassment about their skin or reduction in leisure activities to avoid further sun exposure. At the same time, AKs are known to progress in a significant number of cases to squamous cell carcinoma (SCC), a concern in terms of its metastatic potential.~The primary purpose of developing this questionnaire is to examine how well it can potentially identify patients with actinic keratoses. However, since AK is associated with significant detriment to quality of life for validity/reliability assessment, the investigators propose to give a compilation of four self-assessment questionnaires (not specific to AK but validated for skin health in general) to subjects with at least one actinic keratosis and age- and sex- matched participants without AKs, defined as the control population. These will include the SKINDEX-16, the DLQI and the Skin Health Calculator, as well as a questionnaire composed of items specific to predisposition to AKs to be able to better assess the discriminatory power of the questionnaire.
Inclusion criteria: inclusion criteria:

 Male or female, age 18 years or older being seen in a dermatology clinic

 Informed consent of participation must be given by subject

Exclusion criteria: :

 Inability to complete all study questionnaires.

 Subjects who are unable to read and write English

['AKRQ questionnaire', 'Skindex-16, DLQI, Skin Health Calculator']

AKRQ questionnaire
Skindex-16
DLQI
Skin Health Calculator


An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus Types in Women in Egypt

Summary: The purpose of the study is to determine the Human Papillomavirus (HPV) prevalence and HPV type distribution among women aged >= 18 years, attending out-patient health services for gynaecological examination and who agree to HPV testing in Egypt .
Inclusion criteria: inclusion criteria:

 Women >= 18 years of age attending a clinic for gynaecological examination.

 Women who agree to provide a cervical sample for human papillomavirus testing.

 Written informed consent obtained from the subject.

Exclusion criteria: :

 Referral for abnormal cervical sample at the current visit.

 Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed.

 History of hysterectomy.

 Known diagnosis of immunosuppression, or patient on immunosuppressives.

 Pregnant women.

 Having received one or more doses of HPV vaccine prior to participating in the study.


Flu Vaccination in Congestive Heart Failure

Summary: We evaluated the preventive impact of vaccination on subsequent death events in 117 severe congestive heart patients requiring ventilator support without endotracheal intubations and aggressive medical therapy.~They were randomly allocated in a single-blind manner as a unique intramuscular influenza vaccination or as controls.~The first primary outcome evaluated at 6 months follow-up - cardiovascular death - occurred in 3% of the patients in the vaccine group Vs 17% in controls (p=0.022). The composite end point occurred in 33% of the patients in the vaccine group Vs 74% in control group, p = <0.001.
Inclusion criteria: inclusion criteria:

 Male or female patient's > 21 years of age with a severe congestive heart failure (New York Heart Association class III or IV) requiring an immediate administration of intravenous vasodilators drugs, oxygen therapy, and no less than 160 mg of intravenous furosemide were eligible for inclusion.

 Definite evidence of underlying heart failure was also required as shown by at least two of the following:

 a) Orthopnea on admission

 b) X-ray showing evidences of elevated wedge pressure indicating congestive heart failure

 c) recent prior hospitalization (within the 30 days prior to the index hospitalization) because a congestive heart failure episode

 d) echocardiography data showing a poor left ventricular ejection fraction (0.40 or lower measuring with the biplane Simpson's method

 e) non-invasive ventilation to the maintenance of SaO2 above 90%

 f) wet rales in at least the lower half of the lungs fields

 Patients with a final diagnosis of Congestive Heart Failure as a consequence of necrotic or chronic ischemic heart disease, or infective origin such as chronic Chagas Disease, chronic valvular heart disease (surgically repaired or not), and idiopathic origin were also included for the present study

Exclusion criteria: :

 Patients with a concomitant infective disease were excluded from the study

 Patients with evidence of evolving with multi organic failure (hepatic or renal dysfunction requiring dialysis), terminal disease, or any impeding cause of follow-up, including contraindications of vaccination, were excluded from the study

 Those with congestive heart failure following unstable coronary artery disease, or prior by-pass surgery, or angioplasty or congestive heart failure complicating myocardial infarction requiring urgent intervention were excluded also

 Those individuals who required mechanical ventilation on admission

 Patients with prior vaccinations were also excluded

 Pregnancy condition was an exclusion criterion

 Those patients who were unable or refused to give a written inform consent was also excluded of the present study

['Flu Vaccine', 'Conventional medical therapy for heart failure']


Breath Analysis in Obstructive Sleep Apnoea

Summary: Clinical trial in patients with obstructive sleep apnoea that are randomised to either continue or withdraw continuous positive airway pressure therapy to identify a disease-specific exhaled breath pattern by mass spectrometry.
Inclusion criteria: inclusion criteria:

 Confirmed OSA (at the time of original diagnosis) with an oxygen desaturation index (ODI) of >20/h.

 Currently >20/h oxygen desaturations (≥4% dips) during an ambulatory nocturnal pulse oximetry performed on the last night of a 4-night period without CPAP.

 Treated with CPAP for more than 12 months, minimum compliance 4h/night, apnoea-hypopnoea index (AHI) <10 with treatment (according to CPAP- download) and current ESS <10.

 Age between 20 and 75 years at trial entry.

Exclusion criteria: :

 Previous ventilatory failure (awake SpO2 <93% and PaCO2>6kPa).

 Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension or hypotension (>180/110 or <90/60mmHg)

 Previously diagnosed with Cheyne-Stokes breathing.

 Current professional driver; any previous sleep related accident.

 Acute inflammatory disease.

 Acute or chronic hepatic disease.

 Renal failure or renal replacement therapy.

 Use of inhaled drugs.


Atrial Fibrillation Detected by Continuous ECG Monitoring

Summary: The LOOP study aims to determine whether screening for atrial fibrillation (AF) with implantable loop recorder and initiation of oral anticoagulation (OAC) if AF is detected will reduce the risk of stroke and systemic arterial embolism in patients with risk factors for stroke.
Inclusion criteria: inclusion criteria:

 Age 70-90 years, and

 Previously diagnosed with ≥1 of:

 Diabetes mellitus (type 1 or type 2, with or without medical therapy)

 Hypertension (with or without medical therapy)

 Heart failure

 Previous diagnosed stroke (previous transient ischemic attack is not considered an inclusion criterion)

Exclusion criteria: :

 History of atrial fibrillation or flutter irrespective of type

 Cardiac pacemaker or defibrillator (with or without re-synchronization therapy)

 Contraindication to oral anticoagulation therapy

 Anticoagulation therapy; vitamin K antagonists, direct oral anticoagulants, or (low-molecular) heparins. Therapy with platelet inhibitors such as acetyl-salicylic acid, clopidogrel, persantine is not considered an exclusion criterion

 Renal failure treated with permanent dialysis

 Uncorrected congenital heart disease, or severe valvular stenosis, obstructive cardiomyopathy, active myocarditis, or constrictive pericarditis.

 On a waiting list for major surgery (cardiac, thoracic or abdominal)

 Cardiac or thoracic surgery has been performed within 3 months from inclusion

 Any major organ transplant (e.g. lung, liver, heart, or kidney)

 Cytotoxic or cytostatic chemotherapy and/or radiation therapy for treatment of a malignancy within 6 months before randomization or clinical evidence of current malignancy with the following exceptions: Basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, prostate cancer (if stable, localized disease with a life expectancy of > 2.5 years in the opinion of the investigator)

 Life-expectancy shorter than 6 months

 Known to be human immunodeficiency virus (HIV) positive with an expected survival of less than 5 years due to HIV infection

 Recent (within 3 months) history of alcohol or drug abuse based on self-reporting

 Any condition (e.g. psychiatric illness, dementia) or situation, that in the investigators opinion could put the subject at significant risk, confound the study results, or interfere significantly with the subject participation in the study

 Unwillingness to participate or patient does not understand Danish language

['Implantable loop recorder (Medtronic Reveal LINQ(TM))']

['Atrial Fibrillation', 'Stroke', 'Hypertension', 'Diabetes']

Atrial Fibrillation
Stroke
Hypertension
Diabetes


CyberKnife Radiosurgical Treatment of Inoperable Early Stage Non-Small Cell Lung Cancer

Summary: The purpose of this study is to assess the short and long-term outcomes after CyberKnife stereotactic radiosurgery for early stage non-small cell lung cancer (NSCLC) in patients who are medically inoperable.
Inclusion criteria: inclusion criteria:

 Patient must be over the age of 18 years

 Pulmonary nodule with maximum diameter ≤ 5 cm

 Histological confirmation of primary NSCLC

 The following stage of NSCLC patients are eligible:

 Stage I: T1 N0 M0 or T2 N0 M0 (Tumor size ≤ 5 cm)

 Stage II: T3 N0 M0 (Chest wall invasion only, Tumor size ≤ 5 cm)

 ECOG/Zubrod status of 0, 1 or 2

 Thoracic surgery consultation should be obtained from a Board Certified Thoracic surgeon who in collaboration with a radiation oncologist should determine that the patient is not a surgical candidate.

 In order to be considered medically inoperable, the patient must meet at least one major criteria or a minimum of 2 minor criteria as described below:

 MAJOR CRITERIA:

 FEV1 < 50% or predicted postoperative FEV1 < 40%

 DLCO < 50% or predicted postoperative DLCO < 40%

 Exercise induced maximal exercise oxygen consumption M VO2 < 15 mL/kg/min

 High-risk cardiac disease: Any one of the following:

 Poor left ventricular function (defined as an ejection fraction of <=20%)

 Unstable coronary syndromes (unstable angina or severe angina Canadian class III or IV).

 Severe valvular disease (critical valvular stenosis),

 Recent myocardial infarction (< 1 month),

 Significant arrhythmia defined by one of the following: High-grade AV block, Symptomatic ventricular arrhythmias in the presence of underlying heart disease, Supraventricular arrhythmias with uncontrolled ventricular rate

 MINOR CRITERIA:

 Age > 75

 Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mm Hg)

 Oxygen requirement (using the Medicare criteria for home oxygen requirements [i.e., room air oxygen saturation of 88% or less])

 Resting or exercise arterial pO2 ≤ 55 mm Hg OR SpO2 ≤ 88%.

 pCO2 > 45 mm Hg

 Congestive heart failure (any three of the following must be documented: dyspnea, peripheral edema, chest x-ray with interstitial edema or cardiomegaly, rales, or congestion)

 Moderately depressed left ventricular function (defined as an ejection fraction of 21-40% or less)

 Severe cerebral (with CVA or recent TIA) or severe peripheral vascular disease

 Diabetes Mellitus with severe organ damage such as ESRD, Blindness, Vascular disease.

 Severe end organ damage from other causes resulting in ESRD, cirrhosis of the liver or vascular disease

 FEV1 51%-60% or predicted postoperative FEV1 41-50%

 DLCO 51-60% or predicted postoperative DLCO 41-50%

 Modified Medical Research Council Dyspnea Scale ≥ grade 3

 Females of child-bearing age must be using a reliable form of birth control.

 The patient must have a PET-CT scan within 8 weeks of registration.

 The patient must provide a signed and dated written informed consent PRIOR to registration and prior to undergoing any study-related procedures.

 The patient must provide written authorization to allow the use and disclosure of their protected health information.

Exclusion criteria: :

 Excluding the primary cancer targeted for this treatment, the patient has a prior history of cancer (within the last 5 years) or concurrent cancer other than basal cell or squamous skin cancer.

 Visible endobronchial lesion seen in the trachea, carina, major bronchus, lobar or segmental bronchus on bronchoscopy or microscopic disease detected in the trachea, carina, major bronchus, lobar or segmental bronchus.

 The patient's weight exceeds the tolerances of the institution's imaging and CyberKnife platform/couch.

 The patient has received thoracic radiation therapy in the same field as the planned treatment area in the past.

 The patient has completed chemotherapy within less than 30 days of treatment.

 T2: Tumor size > 5 cm, T3 tumors (except T3 by virtue of chest wall invasion and ≤ 5 cm), T4 tumors. Presence of N1, N2 or N3 disease per previously described criteria would be excluded.

 Pancoast tumors would be excluded.

 Current distant metastatic disease (M1) (preferably biopsy proven).

 The patient is a female with child-bearing potential who refuses to take a pregnancy test prior to treatment.

 The patient is pregnant or a female who is nursing an infant.

 The patient is planning on undergoing systemic therapy within 2 weeks after the last fraction of radiation

 The patient has an active systemic or pulmonary infection.


Prevention of Orthostatic Hypotension With Electric Stimulation in Persons With Acute SCI

Summary: Background:~The presence of orthostatic hypotension (OH) as a consequence of blood volume redistribution during verticalisation in persons with spinal cord injury (SCI) is a common condition.~Aims:~To investigate the impact of three different types of electric stimulation (ES) (ES of the abdominal muscles versus ES of lower limb muscles versus simultaneously ES of abdominal and lower limb muscles versus control) on blood pressure stabilization and verticalisation-degrees between 0° and 70°. The hypothesis is, that the ES-induced contractions of the muscles cause a stabilisation respectively an increase of the blood pressure during the tilt-table test.~Subjects:~20 Women and men, at least 18 years of age, following an acute and traumatic SCI, with a lesion level above T6, an American Spinal Injury Association (AIS) Impairment Scale A,B or C and a diagnosis of OH (by tilt table test) were eligible for the study.~Methods:~Each patient underwent randomly three different types of ES sessions while being positioned on a tilt-table. The following sessions were planned:~A) ES of the abdominal muscles B) ES of the lower limb muscles C) Combination of A and B D) Control session (=diagnostic session)~Study type: Intervention Design: Prospective interventional study
Inclusion criteria: inclusion criteria:

 inpatients

 positive diagnosis of OH

 acute traumatic SCI

 lesion level above T6

 AIS A, B or C

Exclusion criteria: :

 fractures of the lower limbs

 decubitus (NPUAP >2)

 massive psychiatric dysfunction

 suicide intention

['ES of the abdominal muscles', 'ES of the limb muscles', 'ES of limbs & abdomen']

ES of the abdominal muscles
ES of the limb muscles
ES of limbs & abdomen

['Spinal Cord Injury', 'Orthostatic Hypotension']

Spinal Cord Injury
Orthostatic Hypotension


An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol 100/25 Microgram (mcg) Inhalation Powder, Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Fluticasone Propionate 250 mcg Inhalation Powder in Adults and Adolescents With Persistent Asthma

Summary: This study is a randomized, double-blind, double-dummy, parallel group, multicenter, non-inferiority study. The study will enroll adult and adolescent asthmatic subjects who are currently receiving mid dose inhaled corticosteroids (ICS) plus long-acting beta2-agonist (LABA) (equivalent to fluticasone propionate [FP]/salmeterol 250/50 microgram [mcg]twice daily [BD]), either via a fixed dose combination product or through separate inhalers. The study consists of a LABA washout period of 5 days and a run-in period of 4 weeks, followed by a treatment period of 24 weeks, and a follow up contact period of one week. The total duration of the study is 30 weeks. Approximately 1461 subjects will be randomized to one of the following three treatments (487 per treatment): fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg once daily (OD) in the evening (PM) via ELLIPTA™ inhaler plus placebo BD via ACCUHALER™/DISKUS™; FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler; FP 250 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler. In addition, all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms. This study will determine if FF/VI 100/25 mcg OD via ELLIPTA inhaler is non-inferior to FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler in adult and adolescent asthmatic subjects already adequately controlled on a twice-daily ICS/LABA.~SERETIDE, ELLIPTA, ACCUHALER, RELVAR, and DISKUS are trademarks of the GlaxoSmithKline Group of Companies.
Inclusion criteria: inclusion criteria

 Subjects must give their signed and dated written informed consent to participate prior to commencing any study related activities.

 Subjects must be outpatients >=12 years of age at Visit 1 who have had a diagnosis of asthma, as defined by the National Institutes of Health, for at least 12 weeks prior to Visit 1 (Note: Countries with local restrictions prohibiting enrollment of adolescents will enroll subjects >=18 years of age only).

 Subjects may be male or an eligible female. An eligible female is defined as having non-childbearing potential or having childbearing potential and a negative urine pregnancy test at Screening and agrees to use an acceptable method of birth control consistently and correctly.

 Subjects must have a FEV1 of >=80% of the predicted normal value.

 Subjects are eligible if they have received mid dose ICS plus LABA (equivalent to FP/salmeterol 250/50 twice daily or an equivalent combination via separate inhalers) for at least the 12 weeks immediately preceding Visit 1.

 All subjects must be able to replace their current SABA treatment with albuterol/salbutamol aerosol inhaler at Visit 1 for use, as needed, for the duration of the study. Subjects must be able to withhold albuterol/salbutamol for at least 6 hours prior to study visits.

 If in the opinion of the investigator the subject's asthma is well controlled.
Exclusion criteria:

 History of Life-Threatening Asthma, defined for this protocol as an asthma episode that required intubation and/or associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 5 years.

 Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 and led to a change in asthma management or in the opinion of the Investigator, expected to affect the subject's asthma status or the subject's ability to participate in the study.

 Any asthma exacerbation requiring oral corticosteroids within 12 weeks of Visit 1 or resulting in an overnight hospitalization requiring additional treatment for asthma within 6 months prior to Visit 1.

 A subject must not have current evidence of Atlectasis, Bronchopulmonary dysplasia, Chronic bronchitis, Chronic obstructive pulmonary disease, Pneumonia, Pneumothorax, Interstitial lung disease, or any evidence of concurrent respiratory disease other than asthma

 A subject must not have any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbated during the study.

 A subject must not have used any investigational drug within 30 days prior to Visit 1 or within five half-lives (t½) of the prior investigational study, whichever is longer of the two.

 Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of RELVAR™ ELLIPTA inhaler, SERETIDE™ ACCUHALER/DISKUS inhaler or FP 250.

 History of severe milk protein allergy.

 Administration of prescription or non-prescription medication that would significantly affect the course of asthma, or interact with study drug.

 A subject must not be using or require the use of immunosuppressive medications during the study.

 A subject will not be eligible if he/she or his/her parent or legal guardian has any infirmity, disability, disease, or geographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspect of this study protocol, including visit schedule and completion of the daily diaries.

 Current tobacco smoker or has a smoking history of 10 pack-years (20 cigarettes/day for 10 years). A subject may not have used inhaled tobacco products or inhaled marijuana within the past 3 months (e.g., cigarettes, cigars, electronic cigarettes, or pipe tobacco).

 A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.

['Fluticasone Furoate/Vilanterol 100/25 mcg via ELLIPTA inhaler', 'Placebo inhalation powders via ELLIPTA inhaler', 'Fluticasone Propionate/Salmeterol 250/50 mcg via ACCUHALER/DISKUS inhaler', 'Placebo inhalation powder via ACCUHALER/DISKUS inhaler', 'Fluticasone Propionate 250 mcg via ACCUHALER/DISKUS inhaler']


Unravelling Targets of Therapy in Bronchial Thermoplasty in Severe Asthma

Summary: Approximately 5% of asthma patients suffer from severe asthma that is characterized by frequent asthma exacerbations resulting in significant morbidity and excessive utilisation of health care resources. Therefore, there is a strong need for improved therapeutic strategies for these patients. Insight in the pathogenesis and molecular pathways active in severe asthma is crucial to reach this goal.~Bronchial Thermoplasty (BT) is a novel, innovative device-based treatment of severe asthma that is based on local, radiofrequent energy delivery in larger airways during bronchoscopy.~Hypothesis:~BT-induced clinical improvement in severe asthma is a consequence of reduction in airway smooth muscle (ASM) mass and (contractile/immunomodulatory) function, inflammation, neural innervation and/or vascular integrity resulting in altered airway remodelling. BT target identification and severe asthma phenotyping are critical for improved patient selection for BT and fundamental to discover novel, specific signalling pathways active in severe asthma.
Inclusion criteria: inclusion criteria:

 Males or females age 18 or greater and 65 or less

 The diagnosis of asthma confirmed by at least one of the following as assessed at least once during the past 5 years before the study:

 Reversibility to β2-agonists ≥12% predicted and ≥200ml after 400μg inhaled salbutamol or equivalent

 Bronchial hyper-responsiveness to methacholine or histamine

 Peak-flow variability of >20% over a period of 14 days

 Fall in FEV1 >12% and >200ml when tapering treatment (ICS, oral steroid, LABA and/or LTRA).

 Subject is taking regular maintenance medication (GINA step 4-5) for past 6 months that includes:

 Inhaled corticosteroid at a dosage ≥500μg fluticasone equivalent per day AND

 Long acting ß2-agonist at a dosage of ≥100μg per day salmeterol dose aerosol or equivalent).

 Per protocol bronchial hyper-responsiveness to methacholine (PC20<4 mg/ml)

 Other asthma medications are acceptable (such as Leukotriene modifiers, Theophylline, Omalizumab treatment (or discontinuation for at least 6 months) Systemic corticosteroid use (≤20mg/day prednisone equivalent))

 Pre-bronchodilator FEV1 ≥50% predicted (stabilized on ICS/LABA) and post-bronchodilator FEV1 ≥60%

 ACQ >1,5 for 2 weeks

 Non-smoker for 1 year or more (former smoker ≤15 pack years)

 Ability to undergo bronchoscopy and BT in the opinion of the investigator.

 Ability and willingness to provide informed consent.

 For women of childbearing potential: non pregnant, non-lactating, and agree to practice an adequate birth control method for the duration of the study.

Exclusion criteria: :

 Asthma exacerbation during the prior 4 weeks.

 Subject has 5 or more hospitalizations for exacerbations of asthma in the previous year or 1 or more ICU admission for mechanical or endotracheal intubation for asthma in the previous year.

 Respiratory tract infection within past 4 weeks

 Subject has a known sensitivity to medications required to perform bronchoscopy

 Subject is using immunosuppressant therapy other than oral steroid therapy

 Subject is on anticoagulant medication including anti-platelet agents.

 Subject has bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 125,000/mm2 or known coagulopathy (INR >1.5).

 Subject has other respiratory diseases including interstitial lung disease, emphysema, cystic fibrosis, mechanical upper airway obstruction, Churg-Strauss syndrome, and allergic bronchopulmonary aspergillosis (total IgE of >1000 Units/mL with positive specific IgE to aspergillus and evidence of central bronchiectasis).

 Subject has segmental atelectasis, lobar consolidation, significant or unstable pulmonary infiltrate, or pneumothorax, confirmed on x-ray. Bronchiectasis on HR-CT-of the chest, both centrally or peripherally will be excluded.

 Subject has clinically significant cardiovascular disease, including myocardial infarction, angina, cardiac dysrhythmia, conduction defect, cardiomyopathy, aortic aneurysm, or stroke at the discretion of the investigator

 Subject has uncontrolled hypertension (>200mmHg systolic or >100mmHg diastolic pressure).

 Subject uses an internal or external pacemaker or cardiac defibrillator.

 Other chronic diseases that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation, e.g. liver, kidney, or nervous system

 Current smokers, and a history of cigarette smoking with >15 pack years total

 Use of investigative drugs or intervention trials in the 4 months prior to enrolment or during the duration of the study

 Any condition or compliance issue which in the opinion of the investigator might interfere with participation inthe study

 BMI >35

 Pre-bronchodilator FEV1 <1.2L

 Extreme coughing

['Bronchial thermoplasty', 'Alair system (Boston Scientific, USA)']

Bronchial thermoplasty
Alair system (Boston Scientific
USA)


Renal Insufficiency Following Contrast Media Administration Trial III

Summary: The urine flow rate (UFR)-guided and the left-ventricular end-diastolic pressure (LVEDP)-guided hydration regimens have been proposed to prevent contrast-induced acute kidney injury (CI-AKI). The REnal Insufficiency Following Contrast MEDIA Administration TriaL III (REMEDIAL III) trial is a randomized, multicenter, investigator-sponsored trial aiming to compare these 2 hydration strategies in high risk patients.~Patients with estimated glomerular filtration rate <45 ml/min/1.73 m2 and/or a high risk for CI-AKI (as defined according to both Mehran's score ≥11 and/or Gurm's score >7) will be enrolled. Patients will be divided in high (>12 mm Hg) and normal LVEDP, non-invasively estimated by transmitral flow velocity to annular velocity ratio (E/E' index). Patients in each group will be randomly assigned to 1) LVEDP-guided hydration with normal saline (LVEDP-guided group). The fluid infusion rate will be adjusted according to the LVEDP as follows: 5 mL/kg/hr for LVEDP <12 mmHg; 3 mL/kg/hr for 13-18 mmHg; and 1.5 mL/kg/hr for >18 mmHg. 2) UFR-rate guided hydration (RenalGuard group). In this group, hydration with normal saline plus low-dose of furosemide is controlled by the RenalGuard system, in order to reach and maintain a high (>300 mL/h) UFR. In all cases iobitridol (an low-osmolar, non ionic contrast agent) will be administered. The primary endpoint is the composite of CI-AKI (i.e., serum creatinine increase ≥ 25% and ≥ 0.5 mg/dl from the baseline value at 48 hours after contrast media exposure) and/or acute pulmonary edema.
Inclusion criteria: inclusion criteria:

 All consecutive patients with chronic kidney disease (CKD) scheduled for coronary and/or peripheral angiography and/or angioplasty with an eGFR <45 ml/min/1.73 m2 and/or

 At high risk for CI-AKI according to Mehran's score ≥11 and/or Gurm's score >7

Exclusion criteria: :

 Age <18 years

 Women who are pregnant

 Acute pulmonary edema

 Acute myocardial infarction

 Recent contrast media exposure

 End-stage CKD on chronic dialysis

 Multiple myeloma

 Current enrolment in any other study when enrolment in the REMEDIAL III would involve deviation from either protocol

 Cardiogenic shock

 Administration of theophilline, dopamine, mannitol and fenoldopam

['RenalGuard system™® (PLC Medical Systems, Inc. Franklin, MA, USA)']


Assessment of the Safety and Efficacy of DERMASTREAM™ - ENZYSTREAM™ System for the Treatment of Chronic Venous Ulcers

Summary: The study objectives are to evaluate DermastreamTM - EnzystreamTM system safety, tolerability and efficacy, as a potent method for debridement of nonhealing lower extremity chronic venous ulcers patients.
Inclusion criteria: inclusion criteria:

 Patient must have a venous leg ulcer

 Participants, either men or women are between 18 and 85 years of age.

 Clinical presentation of venous insufficiency demonstrated by Doppler

 Ankle-Brachial Index > 0.7 by Doppler

 Good palpable pulses in the Posterior Tibial and the Dorsalis Pedis arteries.

 Wound present for at least 6 weeks prior to enrolment.

 Wound length is in the range of: 1.5 - 7 centimeters.

 The necrotic tissue area is at least 20% of wound area. (by clinical evaluation, i.e., inspection).

 Wound San Antonio classification: Grade 1 or 2, Stage A or B.

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

 Participant understands the nature of the procedure and provides written informed consent prior to any study procedure.

 Women of child bearing potential must use adequate birth-control precautions.

Exclusion criteria: :

 Documented sensitivity to Papain, by medical history records.

 Patients in need of surgical debridement.

 Patients with general skin disorders (Psoriasis, Peniculitis ect) that might deteriorate as a result of local trauma.

 Patients with skin disorders unrelated to the ulcer that are presented adjacent to the wound.

 Pain sensation is completely absent (wound area is anesthetic).

 Patients with renal failure. (Cr > 2 mg/dl).

 Patients with impaired hepatic function (ALT, AST or GGT 2-fold higher than normal upper limit value).

 Patients having Hypoalbuminemia: (Albumin < 2gr/dl ).

 Patients with general Immunological disorders that might deteriorate as a result of local trauma.

 Right-side congestive heart failure (CHF) with edema of legs: (NYHA class 2 or higher see APPENDIX 5).

 Participation in another clinical trial within 1 month prior to start of this study.

 Subject unwilling or unable to comply with the requirements of the protocol

['Lower Extremity Chronic Venous Ulcers']


Study of Intradermal Administration of PCEC Rabies Vaccine

Summary: The purpose of this study is to determine immunogenicity and safety of intradermal administration of the PCEC rabies vaccine in adults.
Inclusion criteria: inclusion criteria:

 Laboratory personnel, epidemiologists, EISOs, veterinary students, interns, and other first responders at CDC; other CDC employees; and healthy volunteer adults. Persons who contact the study coordinator will be assessed for possible occupational exposure to rabies using the risk assessment form (appendix E). The volunteers reporting occupational exposure will be selected to enter the study.

 Male or nonpregnant females (as indicated by a negative urine pregnancy test prior to first dose of vaccine), aged 18 years and older.

 Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (i.e., barrier method, abstinence, or licensed hormonal methods) for the entire study period.

 Be in good health, as determined by vital signs (pulse, blood pressure, oral temperature), medical history, and a targeted physical examination based on medical history.

 Able to understand and comply with planned study procedures.

 Provide informed consent prior to any study procedures and be available for all study visits.

 Have health insurance.

Exclusion criteria: :

 Have a known allergy to PCECV.

 Have a known allergy or sensitivity to eggs or latex (in the stopper).

 Have a positive urine pregnancy test prior to first vaccine dose (female of childbearing potential age).

 Are immunosuppressed as a result of an underlying illness or treatment.

 Have active neoplastic disease or a history of any hematologic malignancy.

 Are using oral or parenteral steroids, high-dose inhaled steroids (>800 μg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs.

 Have a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.

 Have an acute illness that is accompanied by an oral temperature greater than 100.4°F, within 1 week of vaccination.

 Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to enrollment in this study, or expects to receive an experimental agent during the 1st month of the study period.

 Have any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

 He/she is a CDC worker under direct supervision of any of the primary study investigators (Dr. Sergio Recuenco, and Dr. Eli Warnock).

['PCEC rabies vaccine given intradermally', 'PCEC rabies vaccine administered intramuscularly']

['Rabies Prevention', 'Rabies Exposure']


Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma

Summary: The purpose of this study is to find out what effect an antibody called Humanized 3F8 (Hu3F8) and a drug called GM-CSF have on the patient and whether it can keep the patient in remission longer and/or prevent recurrence of the disease.
Inclusion criteria: inclusion criteria:

 Patients must have recurrent OS. OS must be verified by histopathology review by the site's Department of Pathology. (Patients registered at MSK must have pathology confirmed by MSK Department of Pathology.)

 Patients must be in a ≥2nd complete remission as indicated by appropriate radiologic evaluations at the time of study entry.

 Patients must be ≥ 1 year of age and ≤ to 40 years of age at the time of enrollment.

 Prior therapy: ≥3 weeks should have elapsed since last cytotoxic therapy, immunotherapy or radiation therapy. More than one week should have elapsed since major surgery.

 NOTE: Minor surgery (e.g. minor biopsy, central venous catheter placement, shunt revision) is permitted within 1 week prior to enrollment)

 Adequate hematopoietic function defined as:

 Absolute neutrophil count ≥ 500/ul

 Absolute lymphocyte count ≥ 500/ul

 Platelet count ≥ 50,000/ul (transfusion independent)

 Adequate hepatic function as defined by:

 Total bilirubin of ≤ 1.5 times upper limit of normal (exception is made for patients with Gilbert's syndrome who may be considered eligible if total bilirubin is ≤ 3 times upper limit of normal).

 AST (SGOT) of ≤ 3 times upper limit of normal

 ALT (SGPT) of ≤ 3 times upper limit of normal

 Adequate renal function as defined by a serum creatinine of ≤ 1.5 times upper limit of normal

 Adequate cardiac function as defined by a shortening fraction of ≥ 28% or an ejection fraction ≥ 50%

 Adequate pulmonary function as defined by no evidence of dyspnea at rest at no history of exercise intolerance

 Adequate performance status as defined by ECOG score of ≤ 2 or Karnofsky/Lansky score ≥ 50%

 Prior treatment with other anti-GD2 antibodies is allowed (prior treatment with Hu3F8 is NOT allowed), but HAHA antibody titer must be negative

 Women of child-bearing potential must be willing to practice an effective method of birth control while on treatment

 Signed informed consent indicating awareness of the investigational nature of this program

Exclusion criteria: :

 Patients with OS in first complete remission.

 Presence of overt metastatic disease at any site.

 Active life-threatening infection.

 Pregnant women or women who are breast-feeding.

 Inability to comply with protocol requirements.

['humanized anti-GD2 antibody', 'GM-CSF']


Proteomics & Glyco-Proteomic Analysis of Follicular Fluid

Summary: To the best of the investigators knowledge, exhaustive characterization of the low and high abundant proteins and glyco-proteins of the Follicular Fluid (FF) has not yet been achieved. Such an analysis may provide critical molecular data on the role of the FF in oocyte maturation and may identify specific changes in the FF proteome of patients with gynecologic problems, such as Polycystic Ovary Syndrome (PCOS).~Specific Aims~To perform a comprehensive analysis of normal human FF using sensitive mass spectrometry in combination with conventional approaches for proteomic evaluation and using HPLC and Western blot for glyco-proteomic analysis.~Characterize differential proteomic and glyco-proteomic patterns of the FF in normal women compared to lean and obese women with PCOS.~To supplement the differential proteomic and glyco-proteomic analysis with steroid hormone analysis in all FF samples.
Inclusion criteria: inclusion criteria: inclusion criteria All

 Female patients undergoing controlled ovarian hyperstimulation (COH), transvaginal oocyte aspiration (TVA), and Saline Infused Sonography (SIS) with UL collection

 Age <35 y/o at time of in vitro fertilization (IVF) cycle

 Normal ovarian function defined Day 3 Follicular Stimulating Hormone (FSH) <8 pg/ml or Anti-Mullerian Hormone (≥ 1.0 ng/ml)

 inclusion criteria Controls:

 Female patients undergoing COH and TVA donating her oocytes

 Female patients undergoing COH and TVA for male factor infertility only (i.e. no female causes of infertility)

 Normal menstrual cycles

 inclusion criteria Lean PCOS:

 Diagnosis of PCOS by Rotterdam Criteria

 BMI ≤ 25 kg/m2 inclusion criteria Classic PCOS

 1. Diagnosis of PCOS by Rotterdam Criteria 2. BMI > 30 kg/m2

Exclusion criteria: :

 Age ≥ 35 y/o

 Female partners with infertility associated diagnosis (i.e. tubal factor, cervical factor, endometriosis)

 Unexplained infertility

['Polycystic Ovary Syndrome', 'Normal Volunteers']

Polycystic Ovary Syndrome
Normal Volunteers


Study of Palliative Care Intervention for Advanced Cancer Patients and Their Caregivers -Educate Nurture Advise Before Life Ends (ENABLE III)

Summary: ENABLE III is a randomized clinical trial that evaluates a phone-based palliative care intervention designed to improve quality of life, mood, and symptom management for patients with an advanced stage cancer and their caregivers.~The primary aims of this clinical trial are to determine whether a palliative care intervention (introduced immediately or 12 weeks after diagnosis) can improve survival, quality of life, mood, symptom intensity and end-of-life care.
Inclusion criteria: inclusion criteria FOR PATIENTS:

 Able to speak and understand English

 Over age 18

 NEW diagnosis, recurrence, or progression of an advanced stage cancer within THIRTY days of the date the patient was informed of the diagnosis by his/her oncology clinician.

 Estimated survival of 2 years or less

 Diagnosed with an advanced stage cancer such as one of the following:

 Lung Cancer: Stage IIIB or IV non-small cell, or extensive stage small cell

 Breast Cancer: Stage IV with poor prognostic indicators including but not limited to: a) >2 cytotoxic regimens for MBC; b) diagnosis of MBC less then or equal to 12 months since completion of adjuvant or neoadjuvant treatment; c) triple negative disease (ER/PR - and Her 2-);d) parenchymal brain mets and/or carcinomatous meningitis

 Gastrointestinal (GI) Cancers: Unresectable stage III or IV

 Genitourinary (GU) Cancers: Stage IV (for prostate cancer inclusion is limited to persons with hormone refractory prostate cancer)

 Brain Cancer: Unresectable, Grade IV

 Melanoma, Stage IV

 Hematologic Malignancies -Leukemia (e.g. acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL) - advanced stage, treatment refractory, poor prognosis cell type or chromosomal abnormalities, older age -Lymphoma- Stage IV or treatment refractory Hodgkin's disease or non-Hodgkin's lymphoma -Multiple Myeloma - elevated β2-microglobulin, albumin <3.5, PCLI >1%, CRP >6µg/mL, elevated LDH, plasmablastic morphology, abnormal. chromosome 13.

 Completion of baseline interview

 inclusion criteria FOR PATIENTS FOR BIOMARKER SUB-STUDY:

 1. Only patients with lung, breast, GI, GU cancer are eligible

 inclusion criteria FOR CAREGIVERS:

 Able to read and understand English

 Anyone identified by the patient as a person who knows you well & is involved in your medical care.

 PATIENT
Exclusion criteria: :

 Dementia or significant confusion (Impaired cognitive status as indicated by a score of 3 or less on the Callahan six-item cognitive screening tool 18)

 Axis I psychiatric diagnosis of severe mental illness (DSM-IV) (e.g. schizophrenia, bipolar disorder, or active substance use disorder)

 Patients will not be excluded if they do not identify a caregiver

 Prior involvement with palliative care service within the last year

 Minimum predicted survival of less than 12 weeks (3 months)

 PATIENT BIOMARKER SUBSTUDY

['Later entry group', 'Early palliative care intervention']

Later entry group
Early palliative care intervention


Comparison of Esomeprazole and Famotidine for Stress Ulcer Prophylaxis in Neurosurgical Intensive Care Unit

Summary: Although stress ulcer is a complication that can cause mortality and morbidity in critical patients, there is still lack of consensus about its prophylaxis. There is also few data available from Taiwan. H2 blockers are commonly used due to convenience. Some prefer sucralfate (a mucosal protective agent) for the sake of less associated nosocomial pneumonia. Recently, proton pump inhibitors were shown to have good prophylactic effects for stress ulcer. Esomeprazole, an isoform of omeprazole, has good acid suppression effect and the tablets are soluble for the use of tube feeding. Our previous study showed that there was no difference for the efficacy of stress ulcer prophylaxis between esomeprazole and sucralfate in patients admitted to medical ICU with at least one risk factor. The prevalence of nosocomial pneumonia was also similar.~We will enroll those patients that have received intracranial surgery and admitted to neurosurgical ICU. After obtaining the consent, we will give them prophylactic drugs for 7 days within 24 hours. They are randomly allocated to 2 groups. Group I: esomeprazole 40 mg qd from NG route or orally; Group II: famotidine 20 mg iv bolus q12h. We will monitor the following data: Glasgow coma scale, APACHE II score, CBC, CXR, stool character and OB test, NG aspirate. If clinical evidence of UGI bleeding occurs, endoscopy will be performed. We define the end point as overt bleeding, death or transfer out of ICU. We will compare the prevalence of UGI bleeding and nosocomial pneumonia in these 2 groups.
Inclusion criteria: inclusion criteria:

 Within 24 hours of admission to Neurosurgical ICU after neurosurgery with ventilator support

Exclusion criteria: :

 Less than 18 y/o;

 Pregnancy;

 Not suitable for medication from NG route,

 Had GI bleeding at admission to ICU

['esomeprazole 40 mg', 'famotidine 20 mg']


An Epidemiological Study Aimed to Record Standard Daily Practice in Managing Patients With Hypercholesterolemia

Summary: This study is aimed to collect the following Serbia-specific epidemiology data on hypercholesterolemia: patents characteristics, patients' management/treatment and physicians' standard practice. In addition, the aim is to determine the proportion of patients on lipid-lowering pharmacological treatment who have reached the LDL-C and HDL-C treatment goals.
Inclusion criteria: inclusion criteria:

 Patients with hypercholesterolemia currently receiving a lipid lowering agent

Exclusion criteria: :

 Pregnancy and lactation.


BP as a New Device for Surgery and Solid Cancer and Hematopoietic System Tumors Treatment. Effects of BP Implantation

Summary: Nanotechnologies applied to General Surgery and Emergency Surgery: The Buckypaper as a new fixing method for prosthetic materials in the treatment of abdominal wall hernias in humans, in laparotomic procedures and as a new device for the treatment of solid cancer and hematopoietic system tumors.~The experimentation on this new material, preliminary conducted on breed female rabbit New Zeeland, will be applicable to human, if the results in terms of toxicity and durability will be comfortable.
Inclusion criteria: inclusion criteria: animal model: New Zeeland female rabbits of 3000 gr of body weight -

Exclusion criteria: : any kind of illness in rabbit subjects

 -

['BP selfstanding felt', 'PP mesh', 'BP intraperitoneal mesh', 'control group']

BP selfstanding felt
PP mesh
BP intraperitoneal mesh
control group

['Hernia of Abdominal Wall', 'Incisional Hernia']

Hernia of Abdominal Wall
Incisional Hernia


Postpartum Uterine Regression

Summary: Uterine leiomyomas are the leading cause of hysterectomy in the United States, accounting for over 200,000 procedures each year. Most epidemiologic studies of uterine leiomyoma show that parity has a protective association with leiomyoma, but the mechanism is not known. Both epidemiologic data and data from an animal model indicate that the protective association is not an artifact resulting from reduced fertility among women with fibroids. We hypothesize that the process of uterine regression following delivery results in loss of small fibroids due to selective apoptosis of transformed cells and the extensive remodeling of the entire uterus.
Inclusion criteria: inclusion criteria:

 Participants in the Right From The Start Study must be 18 years old or older, pregnant, enrolled by 10 weeks of gestation, planning to carry pregnancy to term, no plans to move before delivery, and English speaking. Those who are found to have fibroids at either their 7-week, or 22-week ultrasound examination are eligible for this further postpregnancy study.

 A small substudy of 30 women having MRIs to evaluate the sensitivity of the ultrasound imaging will include only participants with a single fibroid found at the early pregnancy ultrasound.

Exclusion criteria:  FOR MRI:


The Use of Fetal Fibronectin to Predict Delivery Due to Abruptio Placenta

Summary: The purpose of this study is to determine if the presence of fetal fibronectin in the cervicovaginal secretions of pregnant patients with minor maternal trauma predicts impending preterm delivery due to abruptio placenta.
Inclusion criteria: inclusion criteria:

 Singleton intrauterine pregnancy ≥20 weeks and ≤35 weeks gestational age

 Chief complaint of minor maternal trauma including motor vehicle accident, patient fall or assault with absence of maternal conditions outlined in
Exclusion criteria:

['Pregnancy Related', 'Trauma', 'Abruptio Placentae']

Pregnancy Related
Trauma
Abruptio Placentae


The Selection Criteria for the Second-look Endoscopy Among Patients With Bleeding Peptic Ulcers

Summary: The purpose of this prospective study is to identify risk factors which could predict poor fading of SRH or early recurrent bleeding of peptic ulcer hemorrhage after successful endoscopic hemostasis and high-dose PPI infusion. These risk factors will be the selection criteria for patients who are indicated to receive second-look endoscopy.
Inclusion criteria: inclusion criteria:

 Bleeding peptic ulcers with major stigmata of recent hemorrhage

 All of these major SRH are treated by local injection of diluted epinephrine 1:10000 with or without combined therapy with a heater probe, argon plasma coagulation, band ligation, or hemoclip therapy

Exclusion criteria: :

 Bleeding due to tumor or cancer

 Bleeding due to the presence of a Dieulafoy lesion

 Ulcer bleeding due to mechanical factors (i.e., gastrostomy tube induction)

 Proton pump inhibitors use within one week before enrollment

 Failure to establish hemostasis under gastroscopy

 Hypersensitivity to esomeprazole, pantoprazole, or any component of the formulation

 Previously participated in the study

['esomeprazole or pantoprazole', 'Endoscopic hemostasis']

esomeprazole or pantoprazole
Endoscopic hemostasis


Measuring Changes in Acute Pain in the Emergency Department Using Patient Reported Scales

Summary: Patient reported pain, stress, and anxiety measures have been found to be inter-related, but it is not known if they are all associated with receiving opiate medications. The objective of this study is to determine if patients' degree of reported pain, stress, or anxiety is associated with receiving opiate pain medications in the emergency department or at discharge. Alert patients at least 18 years of age and who report pain greater than 3/10 are eligible to participate in the study. Consenting patients complete Visual Analog Scales describing their perceived pain, stress, and anxiety from enrollment until discharge. Demographic data and administration of pain medication is also recorded. Visual Analog Scale scores among patients who received an opioid pain medicine in the emergency department and at discharge will be compared to those who did not.
Inclusion criteria: inclusion criteria:

 Reported pain greater than or equal to 3 out of 10

Exclusion criteria: :

 Less than 18 years of age

 Decreased level of consciousness

 Inability to answer questions

 Prisoner


Safety and Efficacy of Chronic Hypnotic Use

Summary: The purpose of the study is to determine how safe and effective it is for people with insomnia to use zolpidem on a nightly basis for one year.
Inclusion criteria: inclusion criteria:

 age 21-70 yrs

 non-pregnant females who agree to standard birth control for 12 months and males

 two of the following chronic insomnia complaints: >30 min sleep latency, < 6 hrs sleep, or nonrestorative sleep.

 meet DSM-IV criteria for primary insomnia

Exclusion criteria: :

 any acute or unstable illness: conditions making it unsafe for the subject to participate, conditions with a potential to disturb sleep (i.e. acute pain, respiratory infection), and conditions which could interact with the pharmacokinetics or pharmacodynamics of zolpidem.

 chronic illnesses: renal failure, liver disease, seizures, and dementing illnesses.

 current psychiatric diseases: alcohol or substance abuse, depression, and schizophrenia.

 a history of alcohol or substance abuse within the past two years.

 a prestudy positive urine drug screen

 consuming >14 standard (1oz) alcoholic drinks per week

 caffeine consumption >300 mg/day

 smoking during the night (11pm-7am).

 medications including: anxiolytics, hypnotics. both prescription and OTC, (except in the chronic zolpidem group), antidepressants, anticonvulsants, sedating H1 antihistamines (non-sedating second generation H1 antihistamines are allowed), systemic steroids, respiratory stimulants and decongestants, prescription and OTC stimulants, prescription and OTC diet aids, herbal preparations, and narcotic analgesics. All medications and doses will be documented.

 sleep disordered breathing (SDB) defined as >10 apnea-hypopneas events per hour of sleep time or any other primary sleep (e.g., restless legs syndrome) or circadian disorder.


A Study of Ultrasonography With Elastography in Skin Neoplasms

Summary: This study will look at high frequency ultrasound as a medical imaging modality and apply it to skin lesions. Elastography is an ultrasonic method of looking at the hardness of an area. We will use this to try and differentiate between benign and cancerous skin lesions.
Inclusion criteria: inclusion criteria:

 Patients with skin lesions undergoing biopsy for diagnosis.

Exclusion criteria: :

 Patients with skin lesions which do not require biopsy for diagnosis.


Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice (Germany)

Summary: This prospective cohort study will provide information about: characteristics of Rivaroxaban use in patients who are prescribed Rivaroxaban for the first time compared to patients who are prescribed Phenprocoumon for the first time, the occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.
Inclusion criteria: inclusion criteria:

 All male and female patients who have been prescribed for the first time either Rivaroxaban or standard of care from the date of market authorization of rivaroxaban to Dec 31, 2017

Exclusion criteria: :

 Patients who have any record of being dispensed their index drug in the year before index date (i.e. cohort entry), or who qualify for both cohorts on the same day

['Rivaroxaban (Xarelto, Bay59-7939)', 'Standard of care']

Rivaroxaban (Xarelto
Bay59-7939)
Standard of care

['Venous Thrombosis', 'Pulmonary Embolism', 'Atrial Fibrillation', 'Acute Coronary Syndrome']

Venous Thrombosis
Pulmonary Embolism
Atrial Fibrillation
Acute Coronary Syndrome


Phase 3 Study of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine

Summary: Haemophilus influenzae is an important pathogen which can cause primary infection and respiratory viral infection in infants and leaded to secondary infections. The infection of haemophilus is a major cause of morbidity and mortality in infants and children. At present, the developed conjugant Hib vaccine is proved to be safe and effective. Because Hib vaccine can prevent meningitis, pneumonia, epiglottis inflammation and other serious infection caused by Hib bacteria, the WHO suggested that Hib vaccine should be included in the infant's normal immune programming.~Since the use of meningitis aureus polysaccharide vaccine, incidence of a disease in recent years is declined and maintain to the level of 0.5 per 1/100 thousand. But meningitis aureus polysaccharide vaccine with a relatively poor immune response in the infants under the age of two, and the remaining 60% with a low antibody level and a short duration.~The immunogenicity and safety of this vaccine has been proved in older children aged 6-23 months and 2-5 years. And in the phase I study which was conducted in February, 2012, the safety profile of this vaccine is proved to be acceptable in infants aged 3-5 months. The phase III study is aimed to further evaluate the safety and the immunization of the vaccine. The objective of this study is to evaluate the safety of the group A, C polysaccharide meningococcal and type b haemophilus influenzal conjugate vaccine.
Inclusion criteria: inclusion criteria:

 Healthy subjects aged 3 to 5 months, normal intelligence.

 The subjects' guardians are able to understand and sign the informed consent.

 Healthy subjects confirmed by medical history questioning, physical examination and clinical decision and in accordance with vaccination requirements of the investigational vaccine.

 Subjects who can comply with the requirements of the clinical trial program according to the researcher's views.

 Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine.

 Subjects with temperature<=37°C on axillary setting.

Exclusion criteria:  for the first vaccination:

 Subject who has a medical history of Meningitis;

 Subject who has a medical history of any of the following: allergies, seizures, epilepsy, encephalopathy history and so on;

 Subject who is allergic with tetanus toxoid components;

 Subject suffering from thrombocytopenia or other coagulation disorder may lead to contraindication to intramuscular injection;

 Subject who has a history of allergic reactions;

 Any known immunological dysfunction;

 Had received gamma globulin or immune globulin, in the past two weeks

 Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws

 Any acute infections in last 7 days

 Any prior administration of immunodepressant or corticosteroids in last 6month

 Any prior administration of other research medicines in last 1 month

 Any prior administration of attenuated live vaccine in last 28 days

 Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine

 Subject suffering from congenital malformations, developmental delay or serious chronic disease;

 Any acute infections

 Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives

['A+C+hib Conjugate Vaccine', 'Placebo', 'A+C Vaccine', 'Hib vaccine']

A+C+hib Conjugate Vaccine
Placebo
A+C Vaccine
Hib vaccine


A Study of Foscarnet Plus Ganciclovir in the Treatment of Cytomegalovirus of the Eye in Patients With AIDS Who Have Already Been Treated With Ganciclovir

Summary: To examine the safety and tolerance of the administration of ganciclovir and foscarnet given together or alternately; to determine the interactive pharmacokinetics (blood level) profile of long-term combined and alternating therapy with these two drugs. Additional objectives are to examine the effect of these treatments in controlling time to cytomegalovirus (CMV) retinitis progression and to examine the antiviral activity of combined and alternating ganciclovir/foscarnet treatment and development of antiviral resistance. Sight-threatening CMV retinitis occurs in at least 6 percent of AIDS patients. By 1991 (US), there may be 6000 to 10000 patients with CMV retinitis. Many clinical reports suggest that both ganciclovir (DHPG) and foscarnet have an antiviral effect against CMV that is often associated with clinical stabilization. Effectiveness of ganciclovir and foscarnet is correlated with weekly maintenance and since toxicity is dose-limiting in up to 20 percent of patients receiving either drug for long periods, it may be beneficial in long-term maintenance treatment to combine or alternate these two drugs at a lower total weekly dose of each drug.~This strategy may result in a greater net antiviral effect with less toxicity than is seen with either drug alone, because the toxicities of each drug are quite different.
Inclusion criteria: inclusion criteria

 Concurrent Medication:

 Allowed:

 Chemotherapy for Kaposi's sarcoma (excluding interferon) if patient is hematologically stable for at least 30 days prior to entry.

 Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC) after first two weeks of study period if absolute neutrophil count is > 1000 cells/mm3 and hemoglobin = or > 8 g/dl.

 Vancomycin.

 Fluconazole or investigational triazoles (e.g., itraconazole, SCH 39304) for disseminated fungal infection.

 Pneumocystis carinii pneumonia prophylaxis (except parenteral pentamidine).

 Acyclovir or other appropriate medication may be instituted in the event of the appearance of Herpes simplex virus

 (HSV) or Varicella zoster virus (VZV) infections.

 G-CSF or GM-CSF for grade 4 neutropenia.

 Concurrent Treatment:

 Allowed:

 Recombinant human erythropoietin.

 Prior Medication: Required:

 Completion of 14-day course of intravenous ganciclovir induction therapy (2.5 mg/kg IV q8h or 5 mg/kg q12h for 14 days) or foscarnet induction therapy (60 mg/kg q8h adjusted for renal function for 14 days) within 1 week prior to study entry. Patients who do not initiate the study immediately upon completing ganciclovir induction therapy should receive a maintenance ganciclovir regimen of 5 mg/kg/day or 6 mg/kg/day 5 x week or a foscarnet regimen of 90-120 mg/kg/day until initiating study drug.

 Patients must:

 Have a diagnosis of cytomegalovirus retinitis and HIV infection.

 Be capable of giving informed consent. Patients < 18 years of age may participate with the consent of parent, guardian, or person with power of attorney.

 Allowed:

 History of seizure disorder or a central nervous system (CNS) mass lesion.

Exclusion criteria:

 Co-existing Condition:

 Patients with the following conditions or symptoms are excluded:

 Evidence of tuberculous, diabetic or hypertensive retinopathy.

 Osteomalacia, neoplasm metastatic to bone or other bone disease.

 Any clinically significant pulmonary or neurologic impairment (for example, patients who are intubated or comatose).

 Retinal detachment.

 Corneal, lens, or vitreous opacification precluding funduscopic exam.

 Concurrent Medication:

 Excluded:

 Immunomodulators, biologic response modifiers or investigational agents not specifically allowed.

 Aminoglycosides, amphotericin B, probenecid, parenteral pentamidine.

 Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC) until completion of second week of maintenance therapy. ddC use is discouraged but not prohibited because of paucity of experience of this drug with ganciclovir and foscarnet.

 Anti-cytomegalovirus (CMV) therapy:

 Ganciclovir, CMV hyperimmune serum/globulin, interferons, immunomodulators.

 Prophylactic antiviral therapy with acyclovir.

 Patients with the following are excluded:

 Active AIDS-defining opportunistic infection requiring therapy that is currently causing nephrotoxicity or myelosuppression.

 Known hypersensitivity to either of the study therapies.

 Prior Medication:

 Excluded:

 Foscarnet or ganciclovir for CMV retinitis (excluding the 14-day induction period).

 Prior Treatment:

 Excluded:

 Cytomegalovirus (CMV) hyperimmune globulin within 14 days prior to study entry.

['Cytomegalovirus Retinitis', 'HIV Infections']

Cytomegalovirus Retinitis
HIV Infections


Trial of Herb Yuyang Ointment to Diabetic Foot Ulcer

Summary: The purpose of this study is to determine if dressing change with a kind of herb Yuyang ointment is clinically more efficacious and safer than Conventional treatment in the treatment of diabetic foot ulcers.
Inclusion criteria: inclusion criteria:

 In-patient or out-patient patients diagnosed with diabetic foot ulcers

 Gangrene or ulceration occurred more than 3 weeks

 Over 18 years of age

 Gender-open

 The type of diabetes (type 1 or type 2) open

 Patients receive a written informed consent to participate in the trial

Exclusion criteria: :

 Serious complications of heart, liver, lung, kidney damage

 Malignant tumors

 Allergy for Chinese medicine used

 Pregnant women and breast-feeding women


Brief Group Intervention Using EFT (Emotional Freedom Techniques) for Depression in College Students

Summary: Depression is an important mental health concern in college students. This study will recruit students who test positive for moderate to severe depression on the Beck Depression Inventory (BDI). Subjects will be randomly assigned to either a treatment or a control condition. Those in the treatment group will receive four 90 minute group classes using EFT (Emotional Freedom Techniques) to address traumatic memories and other self-identified causes of depression. It will compare them to a no treatment control group.
Inclusion criteria: inclusion criteria:

 A score of 19 or more on the Beck Depression Inventory

 Currently enrolled at the University of Santo Tomas

 Able to read, understand, and complete forms

Exclusion criteria: :

 None


Strong Heart Study

Summary: To determine morbidity and mortality from cardiovascular disease among American Indians and to compare cardiovascular disease risk factor levels among Indian groups living in different geographic areas.
Inclusion criteria: No eligibility criteria
Exclusion criteria:

['Cardiovascular Diseases', 'Heart Diseases', 'Atherosclerosis', 'Asthma', 'Carotid Artery Diseases', 'Coronary Disease', 'Hypercholesterolemia', 'Hypertension', 'Diabetes Mellitus', 'Obesity']

Cardiovascular Diseases
Heart Diseases
Atherosclerosis
Asthma
Carotid Artery Diseases
Coronary Disease
Hypercholesterolemia
Hypertension
Diabetes Mellitus
Obesity


An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants

Summary: The purpose of this observational study is to evaluate the safety and effectiveness of infliximab injection under actual conditions of use in participants, and to learn more about its adverse events.
Inclusion criteria: inclusion criteria:

 Participants with ankylosing spondylitis who did not show adequate response to general treatments and with increased serological indices related to severe axial symptoms and inflammation

 Participants with rheumatoid arthritis who show insufficient response to disease modifying antirheumatic drug (DMARD) including methotrexate

 Participants with serious, active and progressive disease not previously treated with methotrexate or other DMARD

 Participant with moderate to serious plaque psoriasis who are unresponsive, contra indicant or intolerable to the systemic therapy including cyclosporine, methotrexate or Psoralen Ultra-Violet A (PUVA)

 Participant with active, progressive, psoriatic arthritis who have shown insufficient response to DMARD treatment

Exclusion criteria: :

 None

['Infliximab; observational study', 'Methotrexate; observational study']

Infliximab; observational study
Methotrexate; observational study

['Spondylitis, Ankylosing', 'Arthritis, Rheumatoid', 'Psoriasis', 'Arthritis, Psoriatic']

Spondylitis Ankylosing Arthritis Rheumatoid Psoriasis Arthritis Psoriatic


Minimize Radioactive Iodine Ablation Of Remnant Thyroid in Differentiated Thyroid Cancer

Summary: The researchers investigated the rate of biochemical remission in patients without radioactive iodine therapy compared to patients with low dose radioactive iodine treatment in differentiated thyroid cancer patients who underwent total thyroidectomy.
Inclusion criteria: inclusion criteria:

 patients with differentiated thyroid cancer

 recently underwent total thyroidectomy (within 6 months)

 pathological criteria

 T1bN0 : Tumor size 1-2cm with no microscopic extension with multifocality (within three foci)

 T3N0 : Tumor size <=2cm with microscopic extension (less than strap muscle)

 T1-3N1a : 3 or less micrometastatic lymph node

Exclusion criteria: :

 differentiated thyroid cancer with aggressive variant, poorly differentiated thyroid cancer, medullary thyroid cancer, anaplastic thyroid cancer

 gross extension (strap muscle or more)

 thyroid cancer with distant metastasis

 previous remote history of thyroid cancer surgery

 history of cervical external beam radiation therapy

 previous history of comorbid cancer within 5 years

 renal insufficiency (Ccr <30ml/min)

 women with pregnancy or breast feeding


Non-invasive Measuring of Cerebral Perfusion After Severe Brain Injury With Near-infrared-spectroscopy and ICG

Summary: The purpose of this study is to show if it is possible to detect secondary ischemic events in patients with severe brain injury or cerebral haemorrhage with the help of non-invasive near-infrared spectroscopy (NIRS) by using the indocyanine green measuring of cerebral perfusion.
Inclusion criteria: inclusion criteria:

 Patients over 18 years

 onset of clinical symptoms of subarachnoid or intracranial haemorrhage or trauma suffered less than 72h

 indication for implanting a tissue oxygen and intracranial pressure probe

 A signed informed consent by the patient or legal guardian

Exclusion criteria: :

 Persistent epidural, subdural or subcutaneous hematoma in planned area of the NIRS optode

 Open injuries in the area of the planned optodes

 Malignant primary disease under chemotherapy

 pregnancy

 bleeding disorder

 In the short term unfavorable prognosis (eg, bilateral wide and light-fixed pupils)

 Patients with pacemakers or where no MRI compatibility is due to non- removable metal parts

 contraindications for contrast media in CT (eg, iodine allergy)

 Untreated hyperthyroidism

 End Stage Renal Disease

 severe psychomotor agitation

['measuring cerebral perfusion by NIRS with ICG']

['Subarachnoid Hemorrhage, Aneurysmal', 'Intracerebral Hemorrhage (ICH)', 'Traumatic Brain Injury']

Subarachnoid Hemorrhage
Aneurysmal
Intracerebral Hemorrhage (ICH)
Traumatic Brain Injury


Study of Supplementation of Antidepressants With Fish Oil to Improve Time to Clinical Response

Summary: This study will be a randomized controlled trial set in an outpatient clinic, involving patients with major depressive disorder, who will be treated with antidepressant therapy, which will be individually agreed upon by the subject and his or her physician. Patients will be randomized to receive either placebo or fish oil capsules containing eicosapentaenoic acid (EHA) and docosahexaenoic acid (DHA) in addition to their antidepressant medication. Subjects will complete a brief dietary and exercise habits survey at the beginning of the trial to take into account lifestyle factors that may be significant in symptom resolution. Their progress will be monitored over a period of twelve weeks, with standardized rating scales completed by subjects and treating physicians. At the end of the study, scores will be compared between groups to look for differences in timing and degree of symptom improvement to analyze whether improvement occurred faster in the group receiving essential fatty acids (EFAs) than in the one receiving placebo. The primary hypothesis is that supplementation of antidepressant therapy with omega-3 fatty acids will decrease the lag period between the start of therapy and the time of clinically significant symptom improvement. A secondary hypothesis is that the results of this study will be consistent with numerous previous studies showing improvement in symptom control in major depressive disorder when antidepressants are supplemented with omega-3 fatty acids.
Inclusion criteria: inclusion criteria:

 Diagnosis of Major Depressive Disorder.

 Allowed comorbidities: Dysthymia, Anxiety Disorders.

 18 years old or older.

 Males + Females.

 English-speaking.

 Women of reproductive age must be on adequate birth control, either oral contraceptives or using condoms or other barrier methods with spermicidal agents.

 Subjects may be undergoing psychotherapy, but must maintain current psychotherapy status. Must not start therapy if not already in therapy. If in therapy, must have received at least 6 sessions prior to entering the study.

 Subjects may continue taking herbals or supplements during the study, but they may not start any new herbals or supplements during the study.

Exclusion criteria: :

 2 or more failed trials of antidepressants (adequate dose and duration, and documented).

 Substance dependence in the past 6 months.

 Current substance use or abuse (MJ, benzodiazepines, narcotics). If BZD use, patient must be tapered off and wait 1 month before being included in the trial.

 Psychosis.

 Bipolar Affective Disorder Type I, II or NOS.

 Pregnancy (current or planned).

 Unstable medical illness (pt has to be stable for at least 3 months, and may be excluded per investigator discretion).

 Dementia.

 Mental retardation.

 Traumatic Brain Injury.

 History of Stroke.

 History of seizure disorder.

 Electroconvulsive therapy within past 6 months.

 If, at the investigator's discretion, it is suspected that the subject will likely not comply with the study protocol.

 Imminent risk for suicide.

['Omega-3 fatty acid', 'Bovine gelatin capsules']

Omega-3 fatty acid
Bovine gelatin capsules


A Comparison of HIV-Infected Patients With and Without Opportunistic (AIDS-Related) Infection

Summary: The purpose of this study is to understand how changes in the immune system of HIV-infected patients affect their risk for 3 serious infections: Pneumocystis carinii pneumonia (PCP), cytomegalovirus (CMV) retinitis, or CMV organ disease. The purpose also is to understand how anti-HIV medicines may improve the immune system in these patients. (This purpose reflects a change in the AIDS-related [opportunistic] infections studied.) Presently, HIV-infected patients who have had PCP or CMV disease stay on lifelong therapy to prevent the return of the disease. This study is trying to see if a special lab test can help identify which patients can stop this preventive therapy without having another episode of PCP or CMV organ disease. (This rationale reflects a change in the AIDS-related infections studied.)
Inclusion criteria: inclusion criteria

 Patients may be eligible if they:

 Are HIV positive (except Group 3b).

 Are at least 13 years old (consent of parent or guardian required if under 18).

 Patients may be eligible for Group 1a if they:

 Have acute PCP.

 Have never received potent anti-HIV drugs or have not received potent anti-HIV drugs for at least 8 weeks prior to getting PCP.

 Have a CD4 cell count below 200 cells/mm3.

 Patients may be eligible for Group 1b if they:

 Have CMV disease.

 Meet 1 of the following requirements: (1) have never received potent anti-HIV drug containing a protease inhibitor (PI) or a nonnucleoside reverse transcriptase inhibitor (NNRTI), (2) have not received potent anti-HIV drugs for at least 8 weeks before getting CMV disease, or (3) have been on stable anti-HIV therapy for at least 3 months with no new anti-HIV drugs started before CMV disease returned.

 Have a CD4 cell count below 50 cells/mm3 if patient received anti-HIV drugs at any time in the past.

 Have an eye exam (patients with CMV retinitis).

 Patients may be eligible for Group 2a if they:

 Have a history of PCP.

 Are currently receiving potent anti-HIV drugs.

 Have been enrolled in ACTG 888.

 Have been off drugs to prevent PCP for at least 48 weeks prior to study entry.

 Have not developed PCP while on potent anti-HIV drugs.

 Have a CD4 cell count above 200 cells/mm3.

 Patients may be eligible for Group 2b if they:

 Have a history of CMV retinitis.

 Are currently receiving potent anti-HIV drugs.

 Have been off drugs to prevent CMV retinitis for at least 12 weeks prior to study entry.

 Have not developed CMV retinitis while on potent anti-HIV drugs.

 Have a CD4 cell count above 50 cells/mm3.

 Have an eye exam confirming lack of CMV retinitis activity within 28 days before study entry.

 Patients may be eligible for Group 3a if they:

 Are CMV-positive.

 Have never had PCP or CMV disease.

 Have never had a CD4 count below 200 cells/mm3.

 Have never taken medications to prevent PCP or CMV disease.

 Patients may be eligible for Group 3b if they:

 Are HIV-negative.

 Are CMV-positive.

 (The lay eligibility section reflects changes in the AIDS-related infections treated.)

Exclusion criteria:

 Patients will not be eligible if they:

 Have received a vaccine within 14 days of study entry or plan to receive one during the study.

 Have taken GM-CSF, any investigational drugs, or any drugs that might affect the immune system within 30 days of study entry or plan to take 1 of these medications during the study. (Prednisone for patients with PCP and G-CSF is allowed.)

 Abuse drugs.

['Cytomegalovirus Infections', 'Cytomegalovirus Retinitis', 'Pneumonia, Pneumocystis Carinii', 'HIV Infections']

Cytomegalovirus Infections
Cytomegalovirus Retinitis
Pneumonia
Pneumocystis Carinii
HIV Infections


Zilver Flex Post-Market Study in Japan

Summary: Japanese post market clinical study of the Zilver Flex device.
Inclusion criteria: inclusion criteria:

 Symptomatic peripheral arterial disease (PAD) involving the above-the-knee femoropopliteal arteries

Exclusion criteria: :

 -


Operative Versus Conservative Treatment of Scaphoid Fractures

Summary: The aim of this study is to compare the time to return to previous activity~level between operative treatment and non-operative cast immobilization of~patients with an acute complete fracture of the middle part of the scaphoid,~without any dislocation or comminution visible CT-scan.
Inclusion criteria: inclusion criteria:

 Mature skeleton

 Isolated, acute complete fracture of the mid third of the scaphoid

Exclusion criteria: :

 acute fractures of both hands

 one hand missing

 other injuries than scaphoid fractures

 rheumatoid, osteoarthritis or polyarthritis

 previous soft tissue injuries of the hand

 drug or alcohol abuse

 participant in trial during the previous month