To Compare Effect of Sevoflurane Versus Desflurane on the Return of Swallowing Reflexes in the Elderly

Summary: Anaesthesia and surgery has become more common in the elderly as the population survives longer. Anaesthesia in the elderly confers a higher risk which is related to the aging process and the diseases that accompany seniority. As such, there is a need to provide optimal anaesthetic management in order to minimize complications and risks perioperatively. One of the changes associated with ageing is the progressive decrease in protective laryngeal reflexes. Any depression of upper airway reflexes increases the chance of pulmonary aspiration and compromises the maintenance of the airway.~Desflurane is an inhalational agent strongly favored due to its lower solubility in blood, lean tissue and fat as compared to sevoflurane. This enables the agent to be quickly eliminated at the end of surgery, with minimal metabolic breakdown, thus facilitating more rapid emergence as compared to sevoflurane anesthesia in elderly undergoing general anaesthesia. McKay et al conducted a study in 2005 in US, which showed that the choice of inhalational agent itself can influence the return of protective airway reflexes. In the study, the inhalational agent sevoflurane was found to cause significant impairment of swallowing, in comparison with desflurane(1). However, the aforementioned study focussed on the general population. As such, the purpose of this study is to determine whether the choice of inhalational anesthetic (sevoflurane versus desflurane) has similar influence on the return of protective airway reflexes in the geriatric population in Malaysia, and whether the significance is greater in the elderly population.
Inclusion criteria: inclusion criteria:

 Age 60-85 years' old

 Both male and female patients

 ASA I-II

 Body mass index (BMI) ≤ 30 kg/m2

 Elective surgery under general anaesthesia with the use of laryngeal mask airway (LMA) / LMA Proseal / LMA Supreme

 Type of surgery: Urogynecological, General Surgery, Orthopedics, Eye, Vascular, Plastic

 Surgery/anaesthesia lasting for 0.5-3 hours

Exclusion criteria: :

 Patients with difficulty in swallowing, preexisting neuromuscular or central nervous system disorder

 Patients undergoing intra abdominal, thoracic, face, nasal or throat surgery

 Known condition interfering with gastric emptying

 Patients with cognitive or hearing impairment and inability to provide informed consent

 ASA III-IV patients

 Use of muscle relaxant during the course of general anesthesia

 Contraindication or previous adverse response to any of the study drugs


Safety and Efficacy of Autologous Bone Marrow Stem Cells in Treating Spinal Cord Injury

Summary: The projected data related to the burden of spinal cord injuries induced limb paralysis in India is quite alarming. This is attributed to the rapid industrialization and economical development in the country. Increase in vehicular traffic has caused numerous road traffic accidents. Rapid increase in populations, development in the computer technology and real estate business lead to construction of huge buildings which indirectly adds to the injuries due to fall. Spinal cord injuries could not be treated adequately with the prevailing treatment modalities. In view of this, there is definitely an urgent need for finding different methods of treatment for these patients who cannot undergo established modalities of treatment or these have been tried unsuccessfully. Since a large number of these patients will loose their productive life and at the prime of their lives, one such alternate therapy, which seems to offer some promise, is stem cell therapy, which has been well studied and published in prestigious journals.~In our present study, we want to evaluate the safety and efficacy of autologous bone marrow derived stem cells surgically transplanted directly into the lesion site with glial scar resection for 8 indian patients of chronic spinal cord injury and intra-thecal injection for 4 indian patients of acute and subacute injury.
Inclusion criteria: inclusion criteria:

 Must be able to give voluntary (patients may not be able to write) consent.

 Must be able to understand study information provided to him.

 Patients with complete spinal cord trans-section: at least post 6 months after spinal cord Injury (in chronic patients), < 2 weeks in acute category and 2-8 weeks in subacute patients.

 The level of spinal cord injury must be between C4 and T12(neurological level)

 Spinal cord injury categorized in terms of ASIA Impairment scale.

 Age should be between 20-55 years

Exclusion criteria: :

 Mechanical ventilation due to neurological impairment

 Multiple level trauma

 Undetermined size and location of Spinal Cord injury

 Gunshot or other penetrating trauma to the spinal cord

 Longitudinal dimension of injury by MRI is greater than 3spinal segments

 Associated severe head injury

 More than 9cms long bone fracture

 Women who are pregnant or lactating

 Serious pre-existing medical conditions

 Disease or impairment that precludes adequate neurological examination.

 Should not have co-morbidities like Diabetes, Systemic Hypertension etc.

 Severe co-morbidities/bed sores Tests positive for infectious diseases Deranged Coagulation profile and Hb < 8mg/dl


Effects of Hamstring Training in Different Modes on Stabilizing Knee Joints With Anterior Drawer Laxity

Summary: Question: To investigate how different modes of thigh muscles strengthening exercises emphasizing the knee internal rotators can be as effective as possible in improving the static stability and agility of the knees with anterior drawer laxity.~Design: Randomized controlled clinical trial.~Participants and Interventions:~Young men with anterior drawer laxity of the knee were randomly assigned to three experimental groups in different strengthening modes: plate-loaded squat press (SP), plate-loaded kneeling leg curl with internal rotation (KLCIR), and kneeling leg curl (KLC). The control group with stable knees received no training.~Outcome measures: static and dynamic knee stability, isokinetic strength. The purpose of this paper was to find out an optimal solution to the enhancement of the static and dynamic knee stability to a great extent.~Key words: anterior cruciate ligament; agility; knee stability; hamstring; knee internal rotator
Inclusion criteria: inclusion criteria:

 The anterior drawer laxity of the knee joint in this study was defined as anterior displacement over 3 mm discrepancy between bilateral knee joints by a KT-2000 test under 20-pound force.

Exclusion criteria: :

 anterior displacement less than 3 mm discrepancy between bilateral knee joints by a KT-2000 test under 20-pound force.

['plate-loaded kneeling leg curl with internal rotation', 'plate-loaded squat press', 'plate-loaded kneeling leg curl']


Central Hypothyroidism, a Novel Laboratory Measurement

Summary: Medical management of central hypothyroidism is controversial due to lack of reference for evaluation of pituitary negative feedback. Therefore, titration of medical treatment is based on T4 levels, measured with variable laboratory methods. Patients who have central hypothyroidism usually have concomitant deficiencies in other pituitary hormones for which they need replacement therapy such as steroids, testosterone and growth hormone. This combined hormone deficiency makes clinical and laboratory evaluation challenging among these patients. Symptomatically, central hypothyroidism is relatively mild and lack non-specific and it might be overlooked due to other hormonal deficiencies. Replacement therapy for central hypothyroidism is titrated by arbitrary target free T4 levels of above 50th percentile of normal. The goal of our study is to compare the standard results from well known measure methods to a new method for measuring Ft4 using Liquid chromatography - tandem mass spectrometry.
Inclusion criteria: inclusion criteria:

 Clinical evidence of central hypothyroidism: status post pituitary surgery and/or radiotherapy plus laboratory documentation of central hypothyroidism, with or without concurrent hormonal deficiencies in other axes, such as ACTH, LH, FSH

Exclusion criteria: :

 Primary hypothyroidism


A Phase 3 Clinical Trial for a Rabies Vaccine (Vero Cell) for Human Use in Healthy Chinese Subjects

Summary: The purpose of this single-centre, randomized, double-blind, parallel control, phase 3 study is to evaluate the safety and immunogenicity of a rabies vaccine (Vero Cell) for human use in healthy Chinese subjects aged 10-60 years, according to the Essen methods (1-1-1-1-1) vaccination.
Inclusion criteria: inclusion criteria:

 Aged from 10 to 60 years old

 Subjects or legal guardians can and will comply with the requirements of the protocol

 Subjects or legal guardians are able to understand and sign the informed consent

 Healthy subjects judged from medical history after investigator's inquiry

 Subjects with temperature <=37.0°C on axillary setting

Exclusion criteria: :

 Female in lactation or pregnancy, or plan to be pregnant during the study period

 Subject who has allergic history to any vaccine or other medicines

 Subject who has injury history by dogs or other mammals and has been vaccinated with rabies vaccine

 Subject who has serious adverse reaction history after vaccination such as allergies, hives, difficulty in breathing, angioedema or abdominal pain

 Subject with congenital malformation, developmental disorder or serious chronic disease

 Subject with autoimmune diseases or immunodeficiency

 Subject with asthma, unstable over the past two years requiring emergency treatment, hospitalization, intubation, oral or intravenous corticosteroids

 Subject with diabetes (Type I or II) excluding gestational diabetes

 Subject with thyroidectomy history, or require treatment in the past 12 months due to thyroid disease

 Subject with severe angioedema in the past 3 years or require treatment in the past 2 years

 Subject with hypertension and with a blood pressure exceeding 145/95 mmHg at enrollment time

 Subject with coagulation abnormalities diagnosed by doctors (such as clotting factor deficiency, coagulation disorders, platelet disorder) or obvious bruises or blood clotting disorder

 Subject with cancer, or has been treated in active cancer period or not clearly cured, or may recur during the study period

 Subject with epilepsy, excluding those alcohol epilepsy within three years before quitting drinking or those do not need treatment in the past 3 years

 Asplenia, functional asplenia, without a spleen or removal of the spleen caused by any situation

 Guillain-Barre syndrome

 Any prior administration of immunodepressant or corticosteroids in last 6 months

 Any prior administration of blood products in last 3 months

 Any prior administration of other research medicine/vaccine in last 30 days

 Any prior administration of any attenuated live vaccine in last 30 days

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

 Ongoing anti-tuberculosis prevention or treatment

 Subject who cannot comply with the trial requirements, or with mental illness/ dual-stage affective psychosis in the past or at present; or has not been controlled and needs to take psychiatric drugs the past 2 years; or with suicidal tendencies in the past 5 years

 Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent


Pediatric Catheter-related Thrombosis Imaging Study

Summary: This protocol will serve as a pilot study to determine the validity and feasibility of contrast enhanced magnetic resonance imaging (MRI) without and with contrast and/or ultrasound (US) for detection of catheter related deep vein thrombosis (DVT) in children
Inclusion criteria: inclusion criteria:

 Functioning central venous catheter in the upper or lower venous system

 Cohort A: Asymptomatic patients having placement of a new central venous catheter in the last 40±20 days

 Cohort B: Subjects who have experienced symptoms for a CVC-related DVT with a CVC in place or subjects who have been incidentally identified by radiographic imaging (imaging modalities to diagnose an incidental CVC-related DVT may include, but is not exclusive of Echocardiogram, CT scan, MRI, or Ultrasound) performed for other clinical reasons, as having a CVC-related DVT in the veins where the current catheter is placed

 Males and females from full-term newborns to < 18 years

Exclusion criteria: :

 For Cohort A subjects only, present therapeutic dosing of a systematic anticoagulant, systemic thromboprophylaxis or antiplatelet therapy. Local thromboprophylaxis [flushes, low dose infusions of heparin of up to 5 u/kg/hr or locks with heparin, urokinase, t-plasminogen activator] according to standard-of-care at the respective center will be allowed

 Patients unable to undergo contrast enhanced magnetic resonance imaging

 Renal function < 50% of normal for age and size

['Ultrasound', 'Magnetic Resonance Imaging with Contrast', 'Magnetic Resonance Imaging without Contrast']


Home-Based or Clinic-Based Human Papillomavirus (HPV) Screening

Summary: This randomized clinical trial studies home-based HPV or clinic-based Pap screening for cervical cancer. It is not yet known whether home-based screening is more effective, cost-effective, and/or acceptable than clinic-based screening for cervical cancer.
Inclusion criteria: inclusion criteria:

 Able to provide informed consent in English

Exclusion criteria: :

 Have had hysterectomy

 Currently pregnant

 Received treatment of cervical dysplasia with LEEP, cone biopsy, laser procedure or cryotherapy within THREE years

 Received colposcopy of cervix within TWO years

 Received Pap test within ONE year

 Immunocompromised (positive human immunodeficiency virus [HIV] test, transplant recipient, received chemotherapy for cancer, or taking immunosuppressant drugs)

 Decisionally impaired adults requiring a legally authorized representative

['Cervical Papanicolaou Test', 'Cytology Specimen Collection Procedure', 'Questionnaire Administration', 'Screening Method', 'Screening Method']

Cervical Papanicolaou Test
Cytology Specimen Collection Procedure
Questionnaire Administration
Screening Method
Screening Method

['Atypical Squamous Cell of Undetermined Significance', 'Cervical Carcinoma', 'Cervical Intraepithelial Neoplasia Grade 2/3', 'Health Status Unknown', 'Human Papillomavirus Infection', 'Low Grade Cervical Squamous Intraepithelial Neoplasia', 'Stage 0 Cervical Cancer']


Association Between Craniofacial Fractures and Brain Injuries: Diagnostic and Therapeutic Considerations

Summary: This study evaluates the association between traumatic brain injuries and craniofacial or/and skull fractures. Purpose is to find out the amount of missed diagnoses and improve primary diagnostics of trauma patients.
Inclusion criteria: inclusion criteria:

 Severe traumatic brain injury, GCS 8 or less and/or Craniofacial fracture

Exclusion criteria: :

 Died before admitted to hospital


Postoperative Respiratory Depression After Cardiac Surgery

Summary: Coronary artery bypass graft surgery (CABG) is associated with postoperative respiratory depression. In this study we aimed at investigating perioperative parameters that could predict the nadir of postoperative respiratory function impairment.
Inclusion criteria: inclusion criteria:

 patients of both sexes older than 18 years submitted to CABG with CPB, presence of coronary disease confirmed by coronary angiography, use of the left internal thoracic artery and/or saphena, patients who remained in spontaneous ventilation on the first postoperative day, absence of chronic or acute pulmonary disease, and giving written informed consent to participate in the study.

Exclusion criteria: :

 intraoperative change of the surgical technique, surgical complications or complications occurring in the ICU, emergency reoperation, renal failure, failure to agree to continue in the study, presence of other types of heart disease, and presence of pulmonary diseases.


Safety of and Immune Response to an HIV-1 Subtype C Vaccine (AVX101) in HIV Uninfected Adults

Summary: The purpose of this study is to evaluate the safety of and immune response to an alphavirus replicon, HIV-1 subtype C gag vaccine, AVX101, in HIV uninfected adults in the United States, South Africa, and Botswana.
Inclusion criteria: inclusion criteria:

 HIV uninfected

 At low risk for HIV infection

 Willing to receive HIV test results

 Good general health

 Acceptable methods of contraception for females of reproductive potential

 Hepatitis B surface antigen negative

 Anti-hepatitis C virus antibody (anti-HCV) negative or negative HCV PCR if anti-HCV is positive

 Meets educational requirements of the study

Exclusion criteria: :

 HIV vaccines or placebos in prior HIV vaccine trial

 Immunosuppressive medications within 168 days prior to first study vaccine administration

 Blood products within 120 days prior to first study vaccine administration

 Immunoglobulin within 60 days prior to first study vaccine administration

 Live attenuated vaccines within 30 days prior to first study vaccine administration

 Investigational research agents within 30 days prior to first study vaccine administration

 Subunit or killed vaccines within 14 days prior to first study vaccine administration

 Allergy treatment with antigen injections within 30 days prior to first vaccine administration

 Current tuberculosis prophylaxis or therapy

 Serious adverse reaction to a vaccine. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.

 Autoimmune disease or immunodeficiency

 Active syphilis

 Unstable asthma

 Type 1 or type 2 diabetes mellitus

 Thyroid disease requiring treatment in the past 12 months

 Serious angioedema within the past 3 years

 Uncontrolled hypertension

 Bleeding disorder

 Malignancy unless it has been surgically removed and, in the opinion of the investigator, is not likely to recur during the study period

 Seizure disorder requiring medication within the past 3 years

 Asplenia

 Mental illness that would interfere with compliance with the protocol

 Other conditions that, in the judgment of the investigator, would interfere with the study

 Pregnant or breastfeeding


Efficacy and Safety of Low-molecular Weight Heparin for Thromboprophylaxis in Acutely Ill Medical Patients

Summary: Acutely ill immobilized patients are at a high risk for thromboembolic events including deep venous thrombosis or pulmonary embolism. Unfractionated heparin (UFH) and low molecular weight heparins (LMWH) are thought to be effective in preventing thromboembolic events. This study is designed to provide efficacy and safety data for thromboprophylaxis with the LMWH certoparin in comparison to thromboprophylaxis with UFH in acutely ill non-surgical patients.
Inclusion criteria: inclusion criteria:

 Hospitalization due to an acute non-surgical disease

 Significant decrease in mobility

Exclusion criteria: :

 Indication for anticoagulant or thrombolytic therapy

 Major surgical or invasive procedure within the 4 weeks that precede randomization

 Expected major surgical or invasive procedure (including spinal/peridural/epidural anesthesia or lumbar puncture) within the 2 weeks that follow the randomization

 Immobilization due to cast or fracture of lower extremity

 Immobilization lasting longer than 3 days in the period prior to randomization

 Heparin administration longer than 36 hours in the period prior to randomization

 Acute ischemic stroke

 Other protocol-defined inclusion/


Human Safety of Capsaicin Inhalation Challenge Testing for Young and Older Men

Summary: In 2004, the investigators initiated a human Capsaicin inhalation experiment under an Investigational New Drug (IND) protocol approved by the FDA (IND 69,642) and the subject safety procedures instituted and approved by the Institutional Review Board (IRB). As part of the study protocol, inhaled Capsaicin solutions were analyzed using high performance liquid chromatography (HPLC). The investigation employed safety procedures while conducting the human inhalation investigations. In addition, during our investigations we observed discrepancies between the predicted Capsaicin concentrations mixed by a registered pharmacist and the actual capsaicin concentrations determined by HPLC. The stability of Capsaicin solutions stored over a seven month period and refrigerated at 4degrees C and protected against ultraviolet light were examined.
Inclusion criteria: inclusion criteria:

 Men of ages 18 and 30 (Dates of birth 1973-1985) or 55-92 years old (Dates of birth 1911-1948).

 Must not currently be a cigarette smoker. If an ex-smoker then has not smoked for at least 10 years and consumption were no more than 10 pack years.

 Agrees to volunteers for the study and willing to sign the informed consent form.

 There were negative/normal screening tests for the following

 Responses to the questionnaire deny current and prior respiratory diseases (including asthma, emphysema, chronic bronchitis, sinusitis and interstitial lung d9sase) and no current respiratory complaints (e.g., cough, wheezing, shortness of breath, allergic rhinitis, and sinusitis). Subjects must not be taking any cardiac medications or admit to a physician-diagnosed cardiac condition.

 Normal spirometry measurements with FEV1 & FVC greater than 75% predicted and FEV1/FVC more than 69%

 Impedance oscillometry were within normal limits

 Negative physical examination of the chest with absence of wheezing and crackles on auscultation of the chest.

 Exhaled nitric oxide concentration is less than 35 ppb for younger and less than 65 ppb for older groups

Exclusion criteria: :

 men of: ages < 18, 31-54 and >92 years old;

 current cigarette smokers or exsmokers who have smoked within the past 10 years and/or smoked more than 10 pack/years;

 refusal to volunteer for the study and not willing to sign the informed consent form;

 screening test not considered normal by physician/PI and showing one or more of the following:

 one or more positive response to the questionnaire(e.g., current or past respiratory diseases including asthma, emphysema, chronic bronchitis, sinusitis and interstitial lung disease; and/or; current respiratory complaints (e.g., cough, wheezing, shortness of breath, allergic rhinitis, and sinusitis) and/or; admitting to taking a cardiac medication and/or; or physician-diagnosed cardiac condition (e.g., coronary heart disease, angina, myocardial infarction, valvular heart disease, cardiomyopathy, etc.);

 Abnormal spirometry measurements (FEV1 &/or FVC <75% predicted and FEV1/FVC <69%);

 Positive physical examination (performed by Physician/PI) with presence of wheezing and/or crackles on auscultation of the chest;

 Impulse oscillometry >4 times normal limits;

 Exhaled nitric oxide of >35ppb for younger group and >65 ppb for older group. -


Comparison of Ticagrelor And Clopidogrel on Inflammatory Biomarkers And Vascular Endothelial Function

Summary: Ticagrelor inhibits inflammation and improves vascular endothelial cell function to a greater extent than clopidogrel in ST-segment elevation myocardial infarction(STEMI) patients receiving percutaneous coronary intervention.~Ticagrelor can reduce the serum levels of inflammatory biomarkers both in coronary and in peripheral venous in patients with ST-segment elevation myocardial infarction(STEMI).
Inclusion criteria: inclusion criteria:

 Male or non-pregnant female.

 Age ≥ 18 years old and <80 years old.

 Consecutive patients who should be hospitalized with documented evidence of ST-Segment Elevation Myocardial Infarction receiving Percutaneous Coronary Intervention.

 All patients havepersistent≥0.2 Millivolt ST segment elevation in two or more contiguous precordial leads or ≥0.1 Millivolt ST elevation in two or more contiguous limb leads, with one of the following: persistent chest pain or elevatory of biomarkers of myocardial necrosis.

 Time from chest pain onset to receiving Percutaneous Coronary Intervention <12 hours.

 Persistent chest pain <12 hours.

 Provision of informed consent prior to any study specific procedures.

Exclusion criteria: :

 Involved in other trials.

 In recent one year have P 2 Y 12 receptor antagonist drug treatment history or long-term use of immunosuppressive agents.

 Recurrent myocardial infarction or previous history of Coronary Artery Bypass Graft(CABG) surgery or rescue Percutaneous Coronary Intervention.

 Active bleeding or bleeding history.

 With obvious infection and body temperature (axillary temperature) higher than 38.0 ℃.

 Autoimmune diseases.

 Malignancies.

 In recent 6 months have received major surgery.

 Left ventricular ejection fraction is less than 30%.

 Life expectancy less than one year.

 With moderate and severe liver function deterioration.

 End-stage renal failure.

 Other conditions that may put the patient at risk or influence study results in the investigators' opinion：eg, increased risk of bradycardiac events; known clinically important thrombocytopenia; known clinically important anemia; severe hemodynamic instability.

 Other contraindications to investigate products.

 Any condition that increases the risk for noncompliance or being lost to follow-up.

['ST-Segment Elevation Myocardial Infarction']


The Value of the Canadian CT Head Rule and the New Orleans Criteria in Minor Head Trauma

Summary: The New Orleans Criteria (NOC) and the Canadian CT Head Rules (CCHR) have been developed to decrease the number of normal computed tomography (CT) in mild head injury (MHI). The aim is to compare the clinical performance of these 2 decision rules for indentifying patients with intracranial traumatic lesions and those who required an emergent neurosurgical intervention following MHI.
Inclusion criteria: inclusion criteria:

 Patient with acute MHI was defined as a patient having a blunt trauma to the head within 24 hours with a Glasgow Coma Scale (GCS) of 13 to 15 and at least 1 of the following risk factors: history of loss of consciousness, short-term memory deficit, amnesia for the traumatic event, post-traumatic seizure, vomiting, headache, external evidence of injury above the clavicles, confusion, and neurologic deficit.

Exclusion criteria: :

 Patients are excluded from the study if they are younger than 10 years, had GCS score of less than 13 or instable vital signs, came to the ED more than 24 hours after head trauma, were pregnant, were taking warfarin or had bleeding disorder, had an obvious penetrating skull injury or had contraindications for CT.


Osteoporosis Screening Trial

Summary: Osteoporosis is the most common disease of bone and characterized firstly by low bone mass and secondly, impaired bone microarchitecture structure resulting in reduced strength and increased risk of fracture. Osteoporosis is divided into: primary (Postmenopausal Osteoporosis Osteoporosis & elderly and senile osteoporosis) and secondary. The most common form is postmenopausal osteoporosis. It occurs in women after menopause and is associated with decreased estrogen production, which normally occurs at this age women Osteoporosis usually occurs after age 50, it is very common in women than in men, and its frequency increases with advancing age.
Inclusion criteria: inclusion criteria:

 Females

 Postmenopausal women

 Outpatients screened for osteoporosis

 Women > 45 years

 Women < 45 years under menopause

 Women obtained their consent to be measured

Exclusion criteria: :

 Premenopausal females

 Women without any symptom of menopause

 Women not obtained their consent to be measured


Levothyroxine Treatment in Thyroid Benign Nodular Goiter

Summary: We will study the effect of taking eltroxin at different time, i.e. fasting or postprandial periods. We will also study the effect of levothyroxin treatment in Chinese people
Inclusion criteria: inclusion criteria:

 age between 20 to 90 years old

 Benign nodular goiter diagnosed with thyroid echo and fine-needle - aspiration cytology

Exclusion criteria: :

 Age younger than 20 or older than 90 years old

 Pregnancy

 Allergy to eltroxin

 Taking other drugs which will have drug interaction with eltroxin

 patients with cardiovascular disease, hypertension, gastrointestinal disease


A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of Inhaled GSK1995057

Summary: GSK1995057 is a fully human, single domain antibody directed against the TNFR1 receptor. The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of inhaled GSK1995057 in healthy subjects. The study will be in two parts. Part 1 is a single-dose escalating design of 5 sequential cohorts of healthy subjects. Part 2 is a single-dose, parallel group design comprising 2 groups of healthy subjects assessing the effect of GSK1995057 on lung inflammation following inhaled LPS challenge. Actual dose administered in Part 2 will be determined from emerging safety and PK data from Part 1 and Study TFR110951.
Inclusion criteria: inclusion criteria:

 Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests nd cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. The investigator may discuss with GSK medical monitor as required.

 Male or female between 18 and 55 years of age inclusive: A female subject is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhoea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) greater than 40 MlU/ml and oestradiol less than 40 pg/ml (less than 140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method. Male subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until the last follow-up visit.

 Normal creatinine clearance values at screening (calculated from serum creatinine by a predicting equation using Cockcroft-Gault formula), normal serum creatinine value as defined by the local reference laboratory, normal urine microscopy and no significant proteinuria on dipstick testing.

 Body weight greater than and equal to 50 kg and BMI within the range 19 - 29.9 kg/m2 (inclusive).

 No evidence of previous or active TB infection and a negative QuantiFERON TB Gold test taken within 7 days of dosing, and negative medical history with respect to active or latent mycobacterium tuberculosis complex infection.

 Normal spirometry (FEV1 greater than and equal to 85% of predicted, FEV1/FVC ratio greater than and equal to 70%) at screening. Predictions should be according to ECCS equations, and race corrections should be made for non-caucasians.

 Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

 Available to complete all study assessments.

 Subjects who are able to use the inhaler device correctly.

 Able to read, comprehend and write English at a sufficient level to complete study related materials.

Exclusion criteria: :

 A history of Hepatitis B, Hepatitis C or HIV infection and/or a positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening

 Current or chronic history of liver disease, or known hepatic or biliary abnormalities. (With the exception of known Gilbert's syndrome or asymptomatic gallstones).

 A positive pre-study drug/alcohol screen.

 History of and/or a positive test for toxoplasmosis consistent with active toxoplasmosis infection at the time of enrollment.

 A positive RT-PCR test for influenza A/B.

 Current evidence or history of an influenza-like illness as defined by fever (greater than 380C) and two or more of the following symptoms within the last 7 days: cough, sore throat, runny nose, sneezing, limb/joint pain, headache, vomiting/diarrhoea in the absence of a known cause, other than influenza.

 Corrected QT interval (QTc) >450msec.

 History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 21 units for males or greater than 14 units for females. One unit is equivalent to 8 g of alcohol and the following can be used as a guide: a half-pint (approximately 240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.

 The subject is unwilling to abstain from alcohol consumption from 24 hr prior to dosing until discharge from the clinic, and for 24 hr prior to all other out-patient clinic visits.

 Subjects with a smoking history of greater than 5 cigarettes per day in the last 3 months (Part 1); smokers are not eligible to take part in Part 2.

['GSK1995057', 'bronchoalveolar lavage', 'LPS', 'Placebo']

GSK1995057
bronchoalveolar lavage
LPS
Placebo


Adaptation of the Pediatric Asthma Control & Communication Instrument (PACCI) in a Pediatric Emergency Department

Summary: This study examined whether the Pediatric Asthma Control and Communication Instrument for the Emergency Department (PACCI-ED), a 12-item questionnaire, can help doctors in the emergency department accurately assess a child's asthma control.~This study involved an intervention with the doctors in the emergency department of an urban pediatric hospital. The intervention was done when one of the doctors involved in the study treated a child aged 1-17 years for an asthma exacerbation. Parents answered questions on the PACCI-ED about their children's asthma. Half of the doctors were allowed to see the PACCI-ED results and half were not. The two groups of doctors were compared on their ability to correctly identify asthma control categories, whether a child's asthma was worsening or improving, whether the family was administering controller medications as often as they should, and how much burden the child's asthma was for the family.
Inclusion criteria: inclusion criteria:

 Child presented to study institution emergency department during study period

 Child was 1 - 17 years-old

 Child has physician-diagnosed asthma by parent report

 Attending physician for child believed emergency department visit was due to asthma

 Attending physician for child completed informed consent and was randomized to PACCI-ED or control group at beginning of study

Exclusion criteria: :

 Child has major pulmonary or cardiac co-morbid illness

 Family of child was non-English speaking

 Child was triaged to the med-trauma bay for severe respiratory distress


Aldosterone Blockade in Heart Failure

Summary: Heart failure causes significant morbidity and mortality and is the most rapidly increasing cardiovascular diagnosis in North America overall prevalence is estimated at 0.4% to 2.4%. Recently, heart failure with a preserved ejection fraction (HFNEF) was found in up to 50% of patients with symptomatic heart failure. Many studies have demonstrated that HFNEF has a poor prognosis with a mortality rate of up to 8% per year and a 50% chance of needing to be admitted to hospital in the next year. There are no proven therapies for this type of heart failure.~Aldosterone blockers (these drugs block a hormone that is elevated in patients with heart failure) are used in other types of heart failure. Our goal is to see if this type of drug improves the function of the heart by looking at the thickness of the heart muscle using MRI. Also we will measure the amount of tissue formation and breakdown in the heart. The trial will be done using both the drug and a placebo so that we can see what effects are due to the drug.
Inclusion criteria: inclusion criteria:

 HF by Framingham criteria

 At least one admission to hospital for HF within the last 180 days

 New York Heart Association Class II thru IV

 Echocardiographic criteria:At least moderate diastolic dysfunction, Ejection fraction >45%

Exclusion criteria: :

 Creatinine clearance <40 mls/min/1.73m2

 Potassium >5.0 mmol/L

 Recent acute coronary syndrome in the prior 4 weeks

 Planned revascularization, defibrillator or pacemaker in next 4 months

 Known previous intolerance to aldosterone antagonist


Randomized, Prospective Evaluation of the Toad Brace in Plantar Ulcer Off-loading and Healing

Summary: The TOAD Medical Corporation Brace is a novel device that completely off-loads the foot and has been shown to heal ulcers at a rapid rate in preliminary experience in patients with plantar ulcers. This trial will attempt to show the efficacy of the Toad Brace and is based on the hypothesis that the Toad brace completely offloads the foot and hastens healing rates of diabetic ulcers. The trial will randomize 74 patients with diabetic pedal ulcers to the Toad Brace or conventional therapy. . Quantitative assessment of ulcer rate healing rates will be determined clinically and by blinded, computer-assisted planimetry of digital images over a 12 week period. The pressure on the plantar surface will be measured via a pressure sensor in a subset of patients. The trials will attempt to show markedly reduced pressure on the plantar surface and significantly higher ulcer healing rates with using the Toad Brace.
Inclusion criteria: inclusion criteria:

 Men or women >18 years old

 One or more foot ulcers without clinical evidence of osteomyelitis

 Diagnosis of Diabetes Mellitus*

 University of Texas Grade 1A, 1C, 2A, or 2C ulcer15

 ABI >0.7 and Toe pressure >30mmHg

Exclusion criteria: :

 Limited life-expectancy

 Wounds on calf or shin that would be in contact with the TAG Brace

 Gangrene, active infection

 Osteomyelitis of the foot with the ulcer

 Chronically bedridden/Non ambulatory

 Unable to keep research appointments

 Wide spread malignancy or systemically immunocompromising disease

 Ipsilateral revascularization procedure within the last 30 days.

 Unreliable, unwilling or unable to comprehend informed consent

['Optimal Medical Therapy Debridement + Toad Brace', 'Optimal Medical Therapy - Debridement']


Seprafilm in Open Abdomens: a Study of Wound and Adhesion Characteristics in Trauma Damage Control Patients

Summary: The goal of this study is to test the effects of Seprafilm adhesion barrier on patients who are undergoing open abdomen damage control management for traumatic injuries when compared to no adhesion barrier use. Specifically, the researchers wish to study the effects of Seprafilm adhesion barrier on:~the number and intensity of adhesions,~whether there is any difference between treatment groups (Seprafilm vs. no Seprafilm) who go on to successful definitive abdominal closure,~rate of occurrence of secondary complications (such as abscesses) associated with short- and long-term beneficial effects of reducing adhesion formation,and~whether there is any difference between treatment groups regarding patient functional recovery.
Inclusion criteria: inclusion criteria:

 Trauma patients undergoing DC/OA management for traumatic injury

 Age 18+

 Life expectancy longer than 48 hours

Exclusion criteria: :

 Prisoners

 Pregnant patients

 Younger than 18 years of age

['Open Abdomen', 'Abdominal Adhesions', 'Trauma', 'Wounds and Injury']

Open Abdomen
Abdominal Adhesions
Trauma
Wounds and Injury


Paclitaxel/Carboplatin With or Without Cetuximab in CUP

Summary: The purpose of this study is to determine whether an addition of cetuximab to carboplatin/paclitaxel can improve efficacy in comparison to carboplatin/paclitaxel in patients with carcinoma of unknown-primary.
Inclusion criteria: inclusion criteria:

 Histologic or cytologic proven, non-resectable carcinoma of unknown primary (adenocarcinoma or non-differentiated carcinoma)

 Measurable tumor lesion(s) according to RECIST criteria

 WHO PS 0 to 1

 Paclitaxel/Carboplatin with or without Cetuximab in Adeno- and Undifferentiated CUP (PACET-CUP)

 Signed written informed consent

 ≥ 18 years of age

 Effective contraception for both male and female subjects if the risk of conception exists

 Adequate bone marrow function:

 Neutrophiles blood cell count (NBC) ≥ 1,5x109/L

 Platelet count ≥ 100x109/L

 Hemoglobin ≥ 5,00 mmol/L (8 g/dL)

 Adequate liver and renal function:

 Bilirubin ≤ 1,5 x upper normal level (UNL) and not increasing more than 25% within the last 4 weeks

 ASAT and ALAT ≤ 2,5 x UNL or in case of liver metastases ≤ 5 x UNL

 Serum creatinine ≤ 1.5 x UNL

Exclusion criteria: :

 Previous exposure to epidermal growth factor receptor-targeting therapy

 Previous chemotherapy except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment

 Radiotherapy or major abdominal or thoracic surgery within the last 4 weeks before inclusion

 Concurrent chronic systemic immunotherapy, chemotherapy or hormone therapy

 Investigational agents or participation in clinical trials within 30 days before treatment start in this study

 Clinically relevant coronary disease or myocardial infarction within 12 months before study entry

 Possibility of a curative local treatment (surgery and/or radiotherapy)

 Women with axillary node metastasis as predominant tumor site

 Women with peritoneal carcinomatosis as predominant tumor site

 Men < 50 years old with retroperitoneal or mediastinal lymph node +/- lung metastases as predominant tumor site

 Identification of the primary or suspicion of a specific tumor entity by reference histopathology (i.e., Her-2 positive or hormone receptor positive tumors corresponding to breast cancer, CK7-negative/CK20- positive tumors with high probability for colorectal cancer)

 Peripheral neuropathy > CTC grade I

 Previous malignancy within the last 5 years (except history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment)

 History of severe psychiatric illness

 Life expectancy less than six weeks

 Drug or alcohol abuse

 Known hypersensitivity reaction to any of the components of the study treatment

 Pregnancy (absence to be confirmed by β-hCG test) or lactation period

 Brain metastasis and/or leptomeningeal disease (known or suspected)

 Acute or sub-acute intestinal occlusion or inflammatory bowel disease

['Neoplasms, Unknown Primary', 'Carcinoma']


PALACE 2: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis

Summary: The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis.~Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.
Inclusion criteria: inclusion criteria:

 Males or females, aged ≥ 18 years at time of consent.

 Have a diagnosis of Psoriatic Arthritis (PsA, by any criteria) of ≥ 6 months duration.

 Meet the Classification Criteria for Psoriatic Arthritis (CASPAR) PsA at time of screening.

 Must have been inadequately treated by disease-modifying antirheumatic drugs (DMARDs)

 May not have axial involvement alone

 Concurrent Treatment allowed with methotrexate, leflunomide, or sulfasalazine

 Have ≥ 3 swollen AND ≥ 3 tender joints.

 Males & Females must use contraception

 Stable dose of nonsteroidal anti-inflammatory drugs (NSAIDs), narcotics and low dose oral corticosteroids allowed.

Exclusion criteria: :

 Pregnant or breast feeding.

 History of allergy to any component of the investigational product.

 Hepatitis B surface antigen and/or Hepatitis C antibody positive at screening.

 Therapeutic failure on > 3 agents for PsA or > 1 biologic tumor necrosis factor (TNF) blocker

['Apremilast 20mg', 'Apremilast 30mg', 'Placebo + 20 mg Apremilast', 'Placebo + 30 mg Apremilast']

Apremilast 20mg
Apremilast 30mg
Placebo + 20 mg Apremilast
Placebo + 30 mg Apremilast


The Effect of Fenoldopam in Solitary Partial Nephrectomy Surgery

Summary: This trial will study the effects of fenoldopam on renal function in patients who have a single kidney undergoing surgery to remove part of that kidney secondary to renal cell carcinoma. The investigators will monitor and evaluate throughout the perioperative course the kidney function. Normally kidney function is predicted to show a worsening followed by an improvement after surgery.~The investigators want to specifically identify if the use of fenoldopam lessens the injury to the kidney with this surgery.
Inclusion criteria: inclusion criteria:

 Patients who have a solitary kidney and present for a partial nephrectomy

 Patients who have one atrophic minimally functioning kidney and present for partial nephrectomy on the other kidney

Exclusion criteria: :

 History of current renal disease beyond the diagnosis of renal malignancy

 Insulin dependent diabetes mellitus, myocardial infarction without subsequent coronary artery bypass or angioplasty

 History of congestive heart failure, renovascular occlusion greater than 45 minutes or less than 15 minutes, greater than one half of the solitary kidney resected

 A major perioperative complication that would potentially affect postoperative renal function (myocardial infarction, congestive heart failure, pulmonary embolus, massive hemorrhage and hypotension, ureteral obstruction or vascular thrombosis), and evidence of nephrotoxicity due to antibiotics


Effect of Surface Electrical Stimulation on Movement of the Larynx

Summary: This study will examine whether surface electrical stimulation on the skin of the throat will: 1) move the larynx (voice box); 2) move the vocal folds in the larynx; and 3) cause less movement of the larynx when applied during swallowing. It is important that the larynx moves up and forward while swallowing so that food does not go into the airway. A device called VitalStim® (Registered Trademark), which provides electrical stimulation to the skin on the neck and under the chin, is widely used to treat people who have problems swallowing. This study will determine if VitalStim can move the voice box or the vocal folds in the larynx. This information is important for patients who have long-term problems raising or closing their larynxes when they swallow.~Healthy volunteers between 20 and 60 years of age may be eligible for this study. Candidates are screened with a medical history, physical examination, electrocardiogram, and nasoendoscopy. For the latter procedure, the inside of the subject's nose is sprayed with a decongestant, opening the nasal passages. A small flexible tube called a nasoendoscope is passed through the nose to the back of the throat. The scope allows observation of the larynx while the subject speaks, sings, whistles and makes prolonged vowel sounds.~Participants are familiarized with the VitalStim device before beginning the experimental procedures. The device consists of two sets of electrodes and a stimulation unit. The electrodes are placed on the neck and under the chin. Stimulation causes different sensations, according to the intensity level. They include tingling/crawling, vibrating warm/burning, and grabbing. Subjects then undergo the following procedures:~Nasoendoscopy with muscle stimulation: The inside of the nose is sprayed with a decongestant and the nasoendoscope is passed through one nostril to the back of the throat. Electrodes are placed on the throat area and under the chin. Stimulation is delivered 10 times at various places on the neck and under the chin while the subject sits quietly. This test shows if the vocal folds in the voice box move with surface electrical stimulation.~Videofluoroscopy with muscle stimulation at rest and during swallowing: This is an x-ray study of the head and neck during swallowing and at rest to determine how stimulation affects the level of the voice box in the neck. Electrodes are placed under the chin and on the throat. The subject swallows 5 milliliters of barium, a contrast material that can be seen easily on x-ray. The x-ray machine is turned on for a few seconds at a time during each swallow of the barium and another 10 times while the subject is remaining still without swallowing.
Inclusion criteria: inclusion criteria:

 The Healthy volunteers will be without cardiac, pulmonary, neurological, otolaryngological, psychiatric or speech, swallowing and hearing problems as determined by medical history and examination by a physician.

Exclusion criteria: :

 History of Rheumatic fever, mitral valve prolapse, or cardiac arrhythmias as determined by medical history, physical and EKG. A physician will auscultate for cardiac murmurs prior to any study to exclude volunteers who might be at risk for endocarditis. Subjects will have an EKG as part of the screening for participation in the study.

 Pregnancy will exclude women from participation because the study involves radiation exposure.

 None of the Healthy volunteers will have a reduction in the range of vocal fold movement during the nasoendoscopy that might suggest laryngeal paralysis or paresis, joint abnormality or neoplasm.

 Healthy Volunteers who have a cardiac demand pacemaker, dementia, exhibit non-stop vocalization, significant reflux due to use of a feeding tube, or drug toxicity will not be included for VitalStim, as these are contraindications to use of the device.


Curcumin Bioavailability in Glioblastoma Patients

Summary: Measuring the bioavailability of orally administered curcumin in the tumors of glioblastoma patients.
Inclusion criteria: inclusion criteria:

 Patients harboring Glioblastoma

 Patient will undergo surgery

Exclusion criteria: :

 BMI > 30

 Liver and Kidney Function so compromised that medication is prescribed

['Patient Harboring Glioblastoma That Will Undergo Surgery']


Suicidal Behavior in Patients Diagnosed With Bipolar Disorder

Summary: The purpose of this study is to learn the environmental and psychological factors that impact suicidality in patients diagnosed with Bipolar Disorder. Additionally, the study aims to identify treatments to reduce the suicidal behavior and improve quality of life through a 6-week group-based intervention program.
Inclusion criteria: inclusion criteria:

 English speaking

 Diagnosis of Bipolar Disorder (BD)

 Able to provide written informed consent

Exclusion criteria: :

 Cognitive impairments

 Acutely psychotic

 Medically unstable

 History of schizophrenia spectrum disorder

 History of mood incongruent psychotic symptoms

 History of primary substance disorder

 History of primary organic disease and/or dementia

['Interpersonal and Social Rhythm Therapy (ISRT)', 'Bipolar-Specific Cognitive Behavioral Therapy (CBT)', 'Mindfulness-Based Stress Reduction (MBSR)', 'Psycho-education & Understanding Bipolar Medications Therapy']

['Depression', 'Alcoholism', 'Drug Abuse']


Novel MRI Techniques in the Evaluation of Pulmonary Vascular Disease

Summary: The diagnosis of a patient with pulmonary hypertension (PH) requires many investigations. At present cardiac catheterisation is the cornerstone investigation in these patients where it is used to establish disease severity and estimate prognosis. It is an invasive procedure which is expensive and not without risk to the patient. Despite the multitude of tests performed, identifying those patients with PH who have a poor diagnosis can be difficult. The aim of this study is to improve the assessment of patients with PH using novel magnetic resonance techniques.
Inclusion criteria: inclusion criteria:

 All cases referred to the clinic for assessment for possible pulmonary hypertension.

Exclusion criteria: :

 patients with a cardiac pacemaker or retained temporary pacing wire

 patients with aneurysm clip

 non MRI compatible heart valve prosthesis

 intra orbital metalic foreign body

 pregnancy

 metal prosthesis/spinal rods

 retained shrapnel

 cochlear implants/bladder stimulator


Study of Cerebrospinal Fluid Samples in Diagnosing Carcinomatous Meningitis in Patients With Cancer or Meningeal Syndrome

Summary: RATIONALE: Studying samples of cerebrospinal fluid from patients with cancer or meningeal syndrome may help doctors identify biomarkers related to cancer.~PURPOSE: This clinical trial is studying cerebrospinal fluid samples in diagnosing carcinomatous meningitis in patients with cancer or meningeal syndrome.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Meets 1 of the following criteria:

 Diagnosis of metastatic breast cancer with evidence suggestive of carcinomatous meningitis, with or without brain metastasis

 Other type of cancer with evidence suggestive of carcinomatous meningitis

 Meningeal syndrome without context of cancer

 PATIENT CHARACTERISTICS:

 No other prior cancers

 Not pregnant or nursing

 PRIOR CONCURRENT THERAPY:

 No prior intrathecal treatment

 At least 4 weeks since prior interferon

 No concurrent participation in another clinical trial
Exclusion criteria:

['diagnostic laboratory biomarker analysis', 'immunoenzyme technique', 'magnetic resonance imaging']

['Brain and Central Nervous System Tumors', 'Breast Cancer', 'Metastatic Cancer']

Brain and Central Nervous System Tumors
Breast Cancer
Metastatic Cancer


Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine

Summary: The purpose of this study is to exame the safety of a DNA vaccine against dengue-1.
Inclusion criteria: inclusion criteria:

 Available to participate for the duration of the study (approximately 12 months)

 Completion and review of knowledge assement quiz

Exclusion criteria: :

 Pregnant (by history or as ascertained by pregnancy test) or lactating female

 Female who intends to become pregnant during the study

 Plan to have elective surgery during the study period

 HIV infection

 Known immunodeficiency or currently receiving immunosuppressive therapy (inhaled and topical steroids are allowed)

 History of splenectomy

 Administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine and ending 30 days after vaccination

 Evidence of active (acute or chronic) hepatitis B or C infection

 Autoimmune diseaseor subjects who describe a first-degree relative with clearly documented autoimmune disease

 Acute or chronic, clinically significant cardiac, pulmonary, hepatic, or renal abnormality, as determined by physical examination or basic laboratory screening

 Clinical or laboratory evidence of significant anemia

 History of flavivirus infection or previous receipt of flavivirus vaccine

 Positive serology for flaviviruses (all four dengue virus serotypes, Japanese encephalitis, Yellow fever virus, and West Nile virus), HIV-1, Hepatitis B surface antigen, or anti-hepatitis C virus antibodies prior to enrollment

 Use of any investigational or non-registered drug or vaccine other than the study vaccine within 60 days preceding the first dose of study vaccine, or planned use during the study period.

 Previous history of allergic or anaphylactic reaction to any vaccine

 Planned travel to areas with endemic dengue during the study period

 Any other significant finding which, in the opinion of the investigator, would increase the risk of having an adverse outcome from participating in this protocol

['D1ME100 (dengue-1 premembrane/envelope DNA vaccine)']


Treatment Use of Domperidone for Gastroparesis

Summary: Domperidone is a drug that may be of benefit to individuals with gastroesophageal reflux disease (GERD), with upper GI symptoms, gastroparesis, and chronic constipation.~This is a long-term treatment program for prescription of this drug to all patients who, in the investigators' judgement, could benefit from its use.
Inclusion criteria: inclusion criteria:

 Male or female

 Age 18 and older

 Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to standard therapy.

 Patients must have a comprehensive evaluation to eliminate other causes of their symptoms.

 Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:

 increased prolactin levels

 extrapyramidal side effects

 breast changes

 cardiac arrhythmias including QT prolongation and death

 There is a potential for increased risk of adverse events with the drugs listed in the domperidone protocol addendum.

Exclusion criteria: :

 History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.

 Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc> 450 milliseconds for males, QTc>470 milliseconds for females).

 Clinically significant electrolyte disorders.

 Gastrointestinal hemorrhage or obstruction

 Presence of a prolactinoma (prolactin-releasing pituitary tumor).

 Pregnant or breast feeding female

 Known allergy to domperidone

['Gastroesophageal Reflux Disease', 'GERD', 'Gastroparesis']

Gastroesophageal Reflux Disease
GERD
Gastroparesis


Treatment of External Genital Warts With Cryotherapy and Sinecatechins 15% Ointment

Summary: External Genital Warts (EGW) are the most common sexually transmitted disease associated with more than 30 types of the Human Papillomavirus (HPV). Cryotherapy is an effective method of EGW treatment. However, multiple sessions may be required with reported clearance rates ranging between 27-88%. Sinecatechins 15% ointment is Food and Drug Administration approved for three times daily application in immunocompetent subjects 18 years and older for the treatment of EGW and perianal warts. Treatment of EGW with cryotherapy followed by sinecatechins appears to be logical. Cryotherapy has direct cytodestructive effects with immediate short-term efficacy on treated EGW, while sinecatechins provide field therapy, treating both clinical and sub-clinical lesions. For this study, the investigators used sinecatechins 15% ointment twice daily regimen and anticipated that the synergistic effect with cryotherapy will provide better efficacy that cryotherapy alone. The investigators also anticipated that the sequential therapy with be safe.
Inclusion criteria: inclusion criteria:

 Adults at least 18 years old with at least two visible EGWs.

 Subject must be in good general health as confirmed by the medical history.

 Subject must be able to read, sign, and understand the informed consent.

 Subject must be willing to forego any other treatments for his/her EGW lesions.

 Subject is willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up periods and to comply with all study requirements including concomitant medication and other treatment restrictions.

 If subject is a female of childbearing potential she must have a negative urine pregnancy test result prior to study treatment initiation and must agree to use an approved method of birth control while enrolled in the study.

Exclusion criteria: :

 Subject with any evidence of herpes genitalis or any other current and/or recurrent genital or uncontrolled infection, including Human Immunodeficiency Virus, Hepatitis B or Hepatitis C.

 Subject with an unstable medical condition as deemed by the clinical investigator.

 Subject with any dermatologic disease in the treatment area that may be exacerbated by the treatment proposed or that might impair the evaluation of EGW lesions.

 Subject who has previously been treated in an EGW clinical trial, had treatment of anogenital warts or had systemic intake of virostatics or immunosuppressive medication within 30 days prior to Baseline Visit.

 Women who are pregnant, lactating, or planning to become pregnant during the study period.

 Subject who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc).

 Subject who have active chemical dependency or alcoholism as assessed by the investigator.

 Subject who have known allergies to any component of the study ointment.

 Subject who have organ allograft, skin conditions that may interfere with study ointment, or having internal (vaginal or rectal) warts that have required treatment.

 Subject who has received any of the following within 90 days prior to study treatment initiation:

 interferon or interferon inducers

 cytotoxic drugs

 immunomodulators or immunosuppressive therapies (inhaled/ intranasal corticosteroids are permitted)

 oral or parenteral corticosteroids

 topical corticosteroids if greater than 2 gm/day

 any dermatologic procedures or surgeries on the study area (including any EGW treatments)

 Subject who have used any topical prescription medications on the study area within 30 days prior to study treatment initiation.

['Sinecatechins 15% Ointment', 'Cryotherapy alone']

Sinecatechins 15% Ointment
Cryotherapy alone


Chronic Sleep Deprivation as a Risk Factor for Metabolic Syndrome and Obesity

Summary: OBJECTIVE: Obesity and chronic sleep deprivation have both become increasingly pervasive medical problems in recent years. The prevalence of adult obesity has doubled over the past 30 years and continues to increase. In addition, industrial societies attach an economic value to maximizing the waking period to the longest tolerable limit by sleeping as little as possible. Average sleep time has decreased over the last century by 2 hours. Chronically sleeping less has been associated with increased weight, endocrine and metabolic health risks including glucose intolerance, cardiovascular disease, and mortality. The possibility that the current epidemic of obesity and metabolic health risks may be partially related to insufficient sleep is now being recognized. The objective of this proof-of-concept controlled trial is to investigate the impact of increasing sleep time in chronically sleep-deprived, obese subjects.~STUDY POPULATION: 18-50 year old, obese (BMI 30-50) men and premenopausal women, chronically sleep deprived, recruited from the Baltimore-Washington metropolitan area. Chronic sleep deprivation will be verified by the use of sleep logs and the use of actigraphy before entry into the study. Secondary causes of sleep deprivation such as insomnia, psychological (depression), and medical conditions associated with poor sleep quality (including obstructive sleep apnea) will be exclusionary criteria.~DESIGN: This is a randomized, 12-month duration, comparison-controlled clinical trial of an extension of sleep up to approximately 7 hours and 30 minutes (Intervention Group) or continuation of habitual short sleep schedule (Comparison Group). The proposed treatment is an educational and behavioral intervention aimed at increasing sleep in a non-pharmacological fashion. The main analysis of the study will be to determine if additional sleep will result in a significant difference in body weight at the end of 12 months between the Intervention Group and the Comparison Group. In addition, we would like to establish whether 12 months of additional sleep will result in: a) a decreased prevalence of metabolic syndrome; and b) changes in the endocrine profile (i.e. inducing changes in leptin [increase] and ghrelin [decrease] opposite to the changes associated with chronic sleep deprivation). At the end of the 12-month intervention study (Phase 1, Efficacy Randomized Phase Study), all participants will be given information about the potential benefit of more sleep and encouraged to increase sleep time. Health teaching about proper nutrition and adequate exercise will also be provided at that time to the Intervention and Comparison Groups. All participants will be evaluated 6 months later to assess the effects of this intervention in a real-life situation, and offered participation in a three-year extension with semi-annual visits (Phase 2, Effectiveness 3 Year Follow-Up Phase Study), for which matched external comparison subjects will also be recruited ad hoc.~OUTCOME PARAMETERS: body weight, average number of hours of sleep/night, fasting glucose and insulin, oral glucose tolerance test, leptin, ghrelin, adiponectin, other relevant endocrine and anthropometric measures, body composition, various metabolic parameters, food intake, energy expenditure, and quality of life measures.
Inclusion criteria: inclusion criteria:

 18 to 50 year old obese men and premenopausal women

 BMI between 29-55

 Chronically (for more than 6 months) sleep-deprived, defined as sleeping on a regular basis less than or equal to approximately 6-1/2 hours/night by history and objective devices (wrist activity monitors and sleep logs).

 inclusion criteria: External comparison subjects for extension of Effectiveness Study must meet the criteria above.

Exclusion criteria: :

 Diagnosed sleep disorders including:

 Chronic insomnia

 Untreated sleep disordered breathing (sleep apnea at a level of severity [using standardized criteria for measurement], or diagnosed UARS [upper airway resistance syndrome] that would impair the ability to increase sleep duration [Intervention Group] or maintain sleep duration [Comparison Group]. CPAP treatment that has been in place for 3 months or more and improves sleep is acceptable).

 Restless leg syndrome or periodic limb movement disorder

 Parasomnias (including REM sleep behavior disorders, confusional arousals, sleep terrors, sleepwalking, sleep violence)

 Primary bruxism is allowed as long as it does not interfere with the ability to sleep an additional 90 minutes a night

 Narcolepsy

 Central apnea.

 Unstable weight (voluntary losses in BMI greater than 5% over the past 6 months); currently being enrolled in a weight loss program

 Untreated or uncontrolled diabetes

 Severe uncontrolled hypertension

 Other chronic organ disease diagnosis including:

 COPD

 Chronic cardiac arrhythmia requiring treatments

 Gastro-esophageal disorders associated with sleep-related symptoms.

 Medications

 chronic use of prescription or over-the-counter medications known to affect sleep (e.g., systemic steroids, NSAIDs)

 current anticonvulsant therapy

 Chronic fatigue syndrome and fibromyalgia

 Acromegaly, hypothyroidism (unless on a stable replacement dose of thyroid hormone), Cushing disease or other endocrine disorders known to affect sleep

 Poorly controlled major depression (subjects who have been on a stable pharmacological antidepressant treatment for 3 months and are in remission without substantial weight gain are eligible).

 Other current DSM-IV diagnoses, including:

 Eating disorders such as bulimia nervosa and binge eating disorder

 Anxiety disorders such as PTSD and panic attacks

 Mania

 Schizophrenia.

 Medication and substance abuse such as excessive alcohol consumption or drug abuse or dependence that may pose a threat to compliance

 Being a rotating worker, shift worker (working evenings or nights), or long distance commuter (more than approximately 90 minutes each way), traveling frequently outside of time zone; being in an occupation that may require special vigilance such as driving a truck, bus, or cab; operating heavy machinery; being a pilot or air traffic controller

 Being likely to move to a different geographical area during the study

 Having a sleep partner that would make compliance with study requirements difficult

 Pregnancy and lactation

 Menopause

 Chronic excessive caffeine use (habitual intake of more than 500 mg/day)

 Any condition that in the opinion of the principal investigator makes study participation and compliance problematic.

['Obesity', 'Chronic Sleep Deprivation']


High Versus Standard Dose of Proton Pump Inhibitors (PPIs) in Peptic Ulcer Bleeding

Summary: High intravenous dosage of Proton Pump Inhibitors is not better than standard dosage in bleeding peptic ulcers successfully treated by endoscopic therapy
Inclusion criteria: inclusion criteria:

 Consecutive patients admitted for upper gastrointestinal bleeding secondary to peptic ulcers that have been successfully treated with endoscopic therapy

Exclusion criteria: :

 Variceal esophageal bleeding

 Concurrent PPI use

 Moribund patients

['Peptic Ulcers', 'Upper Gastrointestinal Bleeding']

Peptic Ulcers
Upper Gastrointestinal Bleeding


Hybrid Capture Test on Mobile Unit Program to Improve Cervical Cancer Screening in Brazilian Rural and Remote Areas

Summary: This study evaluates the women cervical samples through molecular tests in order to:~1. Deploy the test careHPV (hybrid capture test) in mobile unities of the Barretos Cancer Hospital to evaluate their performance;
Inclusion criteria: inclusion criteria:

 Any women who come to do the Papanicolaou test at the Barretos Cancer Hospital and in the mobile units on the remote Brazilian areas.

Exclusion criteria: :

 not applicable.

['Cervical Cancer Squamous Cell', 'Human Papilloma Virus Infection', 'Human Papilloma Virus-Related Carcinoma', 'Prevention']

Cervical Cancer Squamous Cell
Human Papilloma Virus Infection
Human Papilloma Virus-Related Carcinoma
Prevention


Study of Prophylactic Topical Dapsone 5% Gel Versus Moisturizer for Cetuximab-induced Papulopustular (Acneiform) Rash in Patients With mCRC or HNSCC Without Previous or Concurrent RT

Summary: The purpose of this study is to see if the investigators can prevent or reduce the severity of the Cetuximab-related acne rash. Two different topical agents will be applied to the skin. One topical agent is the dapsone gel and the other is a skin moisturizer. Dapsone gel is an FDA approved medication that you apply to the face. It is commonly used to treat acne. Skin moisturizers are recommended to patients who receive Cetuximab treatment. In addition to these topical agents they will be given a pill to take once a day. This pill has already been shown to help fight rashes from Cetuximab.
Inclusion criteria: inclusion criteria:

 Patients 18 years or older with underlying diagnosis of metastatic colorectal cancer or head and neck squamous cell carcinoma including newly diagnosed patient

 Patients must provide written informed consent to participate in the study

 Anticipated initiation of cetuximab treatment with or without additional chemotherapy.

 Able to self-administer topical interventions or provide for another person to apply the topical interventions

Exclusion criteria: :

 Females of childbearing potential who are pregnant or nursing

 Patients with allergy, hypersensitivity or other contraindication to dapsone, sulfa antibiotics, or excipients of the dapsone gel product

 Patients with pre-existing dermatologic condition affecting the face and chest that would impair assessment of papulopustular rash including dense and/or long facial hair (per investigator discretion)

 Patients currently using prescription and/or over-the-counter topical medications to the face and/or chest who are unwilling to discontinue use during the trial intervention period (day 0 ± 2 days through day 28 ± 2 days)

 Previous or concurrent radiation therapy to head, neck, and chest (i.e. application sites only)

 Previous therapy with cetuximab within 6 months of consent

['Topical Dapsone 5% Gel', 'Moisturizer', 'oral antibiotics']

Topical Dapsone 5% Gel
Moisturizer
oral antibiotics

['Cetuximab-induced Papulopustular (Acneiform) Rash Who Have', 'Metastatic Colorectal Cancer or Head and Neck Squamous Cell Carcinoma']


Pilot Trial of Antibiotics Versus Surgery for Treating Acute Appendicitis

Summary: The major goal of the project is to demonstrate the feasibility of conducting a multi-center randomized clinical trial of antibiotic therapy versus appendectomy for the treatment of patients with acute uncomplicated appendicitis by conducting a single-site pilot study so as to optimize the chance of a large multi-center clinical trial's future success.
Inclusion criteria: inclusion criteria:

 Adult or child ages ≥5 years;

 Diagnosis of acute uncomplicated appendicitis, confirmed by CT, ultrasound and/or MRI performed within 24 hours of consent, as read by an attending radiologist, and confirmed by consultation of an attending surgeon;

 Ability to provide written informed consent (and for subjects ages 5-17, consent from their parent/guardian and assent if applicable); and

 Negative pregnancy test for subjects who are women of childbearing potential.

Exclusion criteria: :

 instability/severe sepsis, appendiceal perforation by imaging, serious co-morbidities limiting randomization, pregnancy, and inability to complete the treatment protocol.

['1 gm IV ertapenem at enrollment', '1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days', 'Appendectomy']


Prospective Evaluation of Spleen Injury Treatments in Languedoc Roussillon

Summary: Descriptive, prospective, multicenter evaluation of spleen injury treatment in the Languedoc Roussilon region according to trauma severity, morbi-mortality and length of hospitalization.
Inclusion criteria: inclusion criteria:

 Hospitalized for abdominal trauma

 diagnosis of splenic contusion confirmed by scanner or during surgery for hemodynamically unstable cases

 patient has signed a consent form

 patient is a beneficiary of or affiliated with a social security program

Exclusion criteria: :

 Refuses to participate

 Pregnant or breastfeeding

 Patient under guardianship


Study of the Effectiveness and Safety of Desloratadine (Aerius) Syrup in Children With Hayfever With or Without Asthma (P03472)

Summary: The purpose of this study was to test the effectiveness and safety of desloratadine (Aerius) syrup in children with hayfever with or without asthma. Patients took desloratadine syrup once a day for 28 days. Once a week, the doctor measured the patient's hayfever symptoms. The doctor also rated how much relief the patient got from treatment and recorded any side effects.
Inclusion criteria: inclusion criteria:

 Children must be >= 6 to < 12 years of age of either sex and any race.

 Children's parent(s) or legal representative(s) must demonstrate their willingness to participate in the study and comply with its procedures by signing an informed consent

 Children must be free of any clinically significant disease (other than SAR) that would interfere with study evaluations

 Children's parent(s) or legal representative(s) must understand and be able to adhere to dosing and visit schedules, agree to report concomitant medications and adverse events to the Investigator or designee

 The diagnosis of seasonal allergic rhinitis with or without intermittent asthma will be assessed by:

 Clinical history of sneezing, rhinorrhea (nasal discharge/running nose or post-nasal drip), nasal stuffiness/congestion and nasal itching and non-nasal symptoms (eye symptoms) as itching, burning, tearing and redness, during the previous pollen season

 Ascertained skin prick positivity (or RAST positivity) to one of the following: grasses, parietaria, birch, hazelnut (the skin test has to be performed within the last year)

 Children must be clinically symptomatic with SAR at Visit 1 (day 1): the total (nasal + non nasal) symptoms score must be >= 8 with a nasal congestion score of >= 2, and the non-nasal symptoms severity score must be >= 2

 Asthma symptoms (wheezing, cough, difficulty breathing, chest tightness) will be evaluated at visit 1 (day 1) and graded only for child with concomitant asthma

Exclusion criteria: :

 Children who have not observed the designated washout periods for any of the prohibited medications

 Children with persistent asthma (mild, moderate or severe) or perennial allergic rhinitis (PAR)

 Children with rhinitis medicamentosa

 Children who have had an upper respiratory tract or sinus infection that required antibiotic therapy within 14 days prior to Visit 1 (day 1), or children who have had a viral upper respiratory infection within 7 days prior to Visit 1 (day 1)

 Children who have nasal structural abnormalities, including nasal polyps and marked septal deviation, that significantly interfere with nasal airflow

 Children who, in the opinion of the Investigator, are dependent upon nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids

 Children with a history of hypersensitivity to desloratadine or any of its excipients

 Children who have any current clinically significant metabolic, cardiovascular, hepatic, renal, immunologic, neurologic, hematologic, gastrointestinal, cerebrovascular or respiratory disease, or any other disorder which, in the judgment of the Investigator, may interfere with the study evaluations or affect subject safety

 A known lack of response to H1-antihistamines

['Rhinitis, Allergic, Seasonal', 'Asthma']


A Study Comparing Blood Flow and Clinical and Safety Effects of the Addition of Natrecor (Nesiritide), Placebo or Intravenous Nitroglycerin to Standard Care for the Treatment of Worsening Congestive Heart Failure.

Summary: The purpose of this study is to compare the hemodynamic (blood flow) and clinical effects of the study drug, Natrecor (nesiritide, a recombinant form of the natural human peptide normally secreted by the heart in response to heart failure) to those of intravenous nitroglycerin or placebo, when added to the standard care therapy that is usually administered in the treatment of patients with worsening congestive heart failure.
Inclusion criteria: inclusion criteria:

 Patients with dyspnea (difficulty breathing and shortness of breath) at rest, while supine, or immediately upon minimal activity such as talking, eating, or bathing

 having evidence of heart disease, rather than pulmonary disease, as the primary cause for the dyspnea (by demonstrating at least two of the following: jugular venous distension, paroxysmal nocturnal dyspnea or 2-pillow orthopnea within 72 hours before the start of study drug, abdominal discomfort due to hepatosplanchnic congestion, chest x-ray with findings indicative of heart failure)

 having elevated cardiac filling pressures either by clinical estimate in non-catheterized patients, or a measured pulmonary capillary wedge pressure (PCWP) >= 20 mm Hg in catheterized patients

 requiring hospitalization and intravenous therapy for at least 24 hours for the treatment of acutely decompensated heart failure.

Exclusion criteria: :

 NPatients having systolic blood pressure consistently less than 90 mm Hg

 having cardiogenic shock (a sudden decrease in blood pressure that results in decreased perfusion of body tissues and organs), volume depletion, or any other clinical condition that would contraindicate the administration of an intravenous agent with potent vasodilating properties

 having their most recent pulmonary capillary wedge pressure (PCWP) < 20 mm Hg within 24 hours before randomization

 having a clinical status so acutely unstable that the potential subject could not tolerate placement of a right heart catheter or the 3-hour placebo period

 unable to have intravenous nitroglycerin withheld (e.g., intravenous nitroglycerin for management of an acute coronary syndrome).

['Symptomatic Decompensated Congestive Heart Failure', 'Congestive Heart Failure in Acute Coronary Syndrome']


Study of Lyme Neuroborreliosis

Summary: The main purpose of this study is to determine whether four weeks treatment with oral doxycycline is as equally effective as three weeks treatment with intravenous ceftriaxone in patients with Lyme neuroborreliosis. The other purpose is to improve laboratory diagnostics of Lyme neuroborreliosis and further define the manifestations and epidemiology of the disease in Finland.
Inclusion criteria: inclusion criteria for definite Lyme neuroborreliosis (Criteria 1-3 or 1 and 4 fulfilled):

 Neurological symptoms suggestive of LNB without other obvious reasons

 CSF pleocytosis (>4 leukocytes per mikrol)

 Intrathecal production of B. burgdorferi specific antibodies

 Detection of B. burgdorferi DNA in central spinal fluid

 Inclusion Cirteria for possible LNB (criteria 1 and 2 or 3 fullfilled):

 Neurological symptoms suggestive of LNB wihtout other obvious reasons

 Production of B. burgdorferi spesific antibodies in serum

 Erythema migrans during the previous three months

Exclusion criteria: :

 pregnancy and breastfeeding

 women planning to get pregnant in two months

 age under 18

 handicapped persons

 prisoners

 use of any antibiotics two weeks before study treatments begins

 allergy for tetracyclines or cephalosporins


Pragmatic Ischaemic Stroke Thrombectomy Evaluation

Summary: Ischaemic strokes (those caused by blockage in an artery in the brain caused by a blood clot) can be treated with very early use of clot-busting (thrombolytic) drugs to attempt to restore the blood supply and limit the damage, resulting in an increased proportion of people making a recovery to independence after stroke. However, drug treatment only succeed in restoring blood flow in a minority of people with clots in the larger arteries (10-25% depending on the size of the blood vessel) and these people also have the most severe strokes and highest risk of death or dependence as a result of the stroke. Current best treatment is therefore least effective in the group with the most severe strokes. Devices that can be fed through the blood vessels to either remove or break up the blood clot in the brain vessels can open this type of large artery blockage. However, using these devices is a highly skilled procedure and it takes some time both to set up the necessary facilities (including anaesthetic, nurses and medical support) and to reach the blockage. The extra time that is required to use these devices may mean that brain tissue is already irreversibly damaged. If so, then an individual patient cannot benefit and indeed may be harmed by opening the artery. There are no completed clinical trials comparing the outcome in people treated with standard stroke treatment and those treated with devices. PISTE is a randomised, controlled trial to test whether additional mechanical thrombectomy device treatment improves functional outcome in patients with large artery occlusion who are given IV thrombolytic drug treatment as standard care.
Inclusion criteria: inclusion criteria:

 Clinical diagnosis of supratentorial acute ischaemic stroke

 Male or nonpregnant female ≥18 years of age

 Clinically significant neurological deficit and NIHSS score ≥6.

 Eligible for IV rtPA according to standard guidelines and able to be commenced on IV treatment <4.5h after symptom onset.

 Enrolment, randomisation and procedure commencement (groin puncture) possible within 90 minutes of the start of IV rtPA treatment (groin puncture maximum 5.5h after stroke onset).

 Occlusion of the main middle cerebral artery (MCA) trunk, MCA bifurcation or intracranial internal carotid artery(carotidT, M1 or single proximal M2 branch) demonstrated on CTA, MRA, or DSA.

 Interventional device delivery (guide catheter placed beyond aortic arch and angio obtained) can be achieved within 6 hours of onset of the stroke.

 Consent of patient or representative.

 Independent prior to the stroke (estimated mRS 02)

 Expected to be able to be followed up at 3 months

Exclusion criteria: :

 CT evidence of intracranial haemorrhage, or evidence of extensive established hypodensity on CT.

 Clinical history suggestive of subarachnoid haemorrhage even if CT normal.

 Known vascular access contraindications e.g. femoral bypass surgery, tight ipsilateral carotid stenosis, unsuitable proximal vascular anatomy likely to render endovascular catheterisation difficult or impossible.

 Extracranial ICA occlusion or basilar artery occlusion

 Alternative intracranial pathology potentially responsible for the new symptoms

 Medical comorbidities which would preclude safe cerebral vessel catheterisation or which are expected to limit life expectancy to <3 months (eg severe cardiac, renal or hepatic failure, significant coagulopathy, metastatic malignancy)

 Known allergy to radiological contrast

['Mechanical thrombectomy', 'Intravenous rtPA']

Mechanical thrombectomy
Intravenous rtPA


Lung Ultrasound in Pleuritic Chest Pain

Summary: Chest pain is an alarming symptom and one of the most frequent causes of access to the Emergency Departement. Although chest X-ray remains an essential step in the diagnostic process, several studies showed numerous limitations of radiography which frequently is inconclusive. Ultrasonography is a non-radiating imaging technique. Albeit a wide use of ultrasound, the utilization of ultrasound in the study of the lung has only recently been introduced in the clinical practice. Several studies proved that lung ultrasound is useful in the diagnosis of lung consolidation in community acquired pneumonia. Nowadays, ultrasound is not routinely used in the presence of chest pain. Our hypothesis based on clinical experience is that, in patients with pleuritic chest pain, lung ultrasound is very sensitive in detecting pneumonia and other lung diseases (such as pneumothorax) thus performing better than radiography. The primary aim of this study is to verify, in patients affected by pleuritic chest pain, the accuracy of lung ultrasound compared to chest-X-ray. The secondary aim is to evaluate the accuracy of lung ultrasound consolidations in distinguishing lung consolidation in pneumonia, atelectasis, pulmonary infarction, or tumors.
Inclusion criteria: inclusion criteria:

 patient aged 18 years and older

 patient affected by thoracic pleuritic pain

Exclusion criteria: :

 patient affected by a chronic condition causing thoracic pain

 patient affected by acute cardiovascular diseases (e.g. acute coronary syndrome)

['Community Acquired Pneumonia', 'Pleuritis', 'Pulmonary Embolism', 'Lung Cancer']

Community Acquired Pneumonia
Pleuritis
Pulmonary Embolism
Lung Cancer


Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia

Summary: The purpose of the study is to assess the safety and efficacy of fluvastatin in children diagnosed with heterozygous familial hypercholesterolemia
Inclusion criteria: inclusion criteria:

 10-16 years old Heterozygous familial hypercholesterolemia

Exclusion criteria: :

 Homozygous familial hypercholesterolemia Pregnant or lactating females Major surgery during the six month prior study

 Other protocol defined inclusion and

['Heterozygous Familial Hypercholesterolemia', 'Mixed Dyslipidemia']


Electric Stimulation of the Eye to Improve Vision After Trauma

Summary: Transcorneal Electrical Stimulation (TES) using the OkuStim® device delivers electrical impulses to damaged and/or diseased photoreceptor cells. This electric stimulation of the retina may help to preserve visual acuity and/or the visual field.
Inclusion criteria: inclusion criteria:

 You are 18 years or older.

 You have sustained trauma (more than 3 months before this study) OR been diagnosed with Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) (more than 6 months before this study) OR been diagnosed with Multiple Sclerosis (MS) and suffered visual loss (more than 3 months before this study).

 You are willing and able to give written informed consent.

 You are able to commit to enrolling in the study during the full time period of up to 6 months.

Exclusion criteria: :

 You have any other significant ophthalmologic disease or condition (such as glaucoma, retinal degeneration, proliferative diabetic retinopathy, +/- six diopters of myopia, retinal detachment, exudative age-related macular degeneration).

 You have amblyopia (lazy eye) in affected eye, previously diagnosed.

 You are participating in any other interventional clinical trial.

 If you are pregnant OR a woman with childbearing potential who is unwilling to use medically acceptable means of birth control for study duration OR woman unwilling to perform a pregnancy test at study entry/screening.

 You are unable to give signed consent due to memory, medical, communication, language, or mental health problems.

 You are less than 18 years old.

 You are unable or unwilling to complete the evaluation or questionnaire.

 Visual acuity better than 20/40

 Inability to detect phosphenes during threshold detection

 You are on seizure medications, or have a history of epilepsy.

['Transcorneal Electrical Stimulation', 'Sham']

Transcorneal Electrical Stimulation
Sham

['Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)', 'Trauma', 'Multiple Sclerosis (MS)']


Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients (Study P05647)

Summary: This study aims to establish the safety, tolerability, and efficacy of Vytorin (R) (Ezetimibe + Simvastatin) (SCH 465981) on a select population of Filipinos with hypercholesterolemia.
Inclusion criteria: inclusion criteria:

 Outpatient men or women, age 18 years and above

 Patients with primary (heterozygous familial and non-familial) hypercholesterolemia

Exclusion criteria: :

 Known hypersensitivity to Ezetimibe and Simvastatin

 Moderate to severe hepatic insufficiency

 Persistent elevation of serum transaminase levels of more than 1.5 times the upper limit of normal

 Pregnancy or lactation

 Concomitant intake of bile acid sequestrants (resins), nicotinic acid (niacin), fibric acid (fibrates), or cyclosporine

['Vytorin (R) (Ezetimibe + Simvastatin)']


Ischemia Care Biomarkers of Acute Stroke Etiology (BASE)

Summary: The proposed study will validate the clinical use of new biomarker blood tests to identify blood components that may differentiate between diverse stroke etiologies and clinical outcomes as listed below:~Differentiate between cardioembolic and large artery atherosclerotic ischemic strokes, when hemorrhagic stroke is ruled out.~In cases of ischemic strokes of unknown or cryptogenic etiology, determine the ability of biomarker blood tests to predict etiology between cardioembolic and large artery atherosclerotic.~In cases of cardioembolic ischemic stroke, further differentiation of cardioembolic ischemic strokes into those caused by atrial fibrillation (AF) and those not caused by AF.~Differentiate transient ischemic attacks (TIAs) from acute ischemic strokes.~Differentiate TIAs from non-ischemic transient neurological events (TNE) with similar symptoms.
Inclusion criteria: inclusion criteria:

 Patients >18 years of age

 Signs and symptoms suggestive of AIS or TIA

 One of the following:

 BASE - Arrival to the emergency department or hospital within 18 hrs of symptom onset or last known normal time

 BASE 24 - Arrival to the emergency department or hospital within 24 hours +/- 6 hours (i.e. 18 - 30 hour window) of symptom onset or last known normal time and clinical evidence suggesting Acute Ischemic Stroke.

 Head CT or MRI ruling out other pathology such as vascular malformation, hemorrhage, tumor or abscess which would likely be responsible for presenting neurologic symptoms

 Informed consent obtained

Exclusion criteria: :

 Any central nervous system infection, i.e. meningitis or encephalitis in the past 30 days

 Any form of head trauma, stroke or intracranial hemorrhage in the past 30 days

 Known primary or metastatic cancer involving the brain

 Active Cancer defined as a diagnosis of cancer, within 6 months before enrollment, any treatment for cancer within the previous 6 months, or recurrent or metastatic cancer.

 Autoimmune diseases: such as lupus, rheumatoid arthritis, Crohn's disease, ulcerative colitis

 Active infectious diseases (eg. HIV/AIDS, hepatitis C)

 Any underlying medical condition which in the opinion of the investigator would prohibit the patient from providing informed consent

 Major surgery within three months prior to the index event

['Ischemic Stroke', 'Atrial Fibrillation', 'Transient Ischemic Attacks', 'Transient Cerebrovascular Events', 'Thrombotic Stroke', 'Stroke of Basilar Artery', 'Cardioembolic Stroke']

Ischemic Stroke
Atrial Fibrillation
Transient Ischemic Attacks
Transient Cerebrovascular Events
Thrombotic Stroke
Stroke of Basilar Artery
Cardioembolic Stroke


Effectiveness of XCell on Autolytic Debridement of Venous Ulcers

Summary: This clinical trial is designed to evaluate the effect of XCell cellulose wound dressing for its ability to naturally (autolytically) remove nonviable tissue and create a healthy vascular wound bed. Results will compare venous ulcers treated with Xylos XCell cellulose dressing plus standard care to those treated with standard care alone. The hypothesis is that XCell will demonstrate more autolytic debridement than the standard of care.
Inclusion criteria: inclusion criteria:

 Patients of any race and are between 18 and 90 years of age.

 Patients that are able to understand and are willing to give written informed consent.

 Patients that have a non-healing open venous ulcer for at least one month.

 Patients that have greater than 50% of the ulcers surface area covered with non-viable tissue such as fibrin slough, dry crust or a combination of both.

 Patients that have the clinical signs and symptoms of venous ulceration such as varicosities, hyper pigmentation, stasis dermatitis, lipodermatosclerosis, and edema.

 Patients that have a venous ulcer with a surface area of greater than or equal to 1.5 cm2.

 Patients that have an ankle to brachial index (ABI) > 0.70.

Exclusion criteria: :

 Study wound (target ulcer) etiology is other than venous insufficiency.

 Patient has peripheral arterial disease as determined by the following criteria: Ankle/Brachial Index < 0.7 (ulcerated leg), evidence of intermittent claudication.

 Patient has the presence of any of the following in the area of the ulcer: cellulitis, osteomyelitis, and ulcer with exposed bone, tendon or fascia.

 Patient has a known hypersensitivity to dressing components.

 Patient is receiving corticosteroids, immunosuppressive agents, radiation therapy, or chemotherapy where in the investigator's opinion could interfere with wound healing .

 Patient is known to have uncontrolled diabetes mellitus (as defined by the investigator).

 Patient is known to have immunodeficiency disorders that interfere with wound healing.

 Patient has a history of sickle cell anemia, thalassemia, vasculitis, rheumatoid arthritis, lupus erythematosus, polyarteritis nodosa, scleroderma or any connective tissue or collagen vascular disorder.

 Patient has wounds that have been treated with an investigational product within the past thirty days.

 Patient has not signed the informed consent.

['XCell cellulose wound dressing', 'Impregnated gauze dressing']

XCell cellulose wound dressing
Impregnated gauze dressing


Shedding, Immunogenicity and Safety of Quadrivalent Live Intranasal Influenza Vaccine (QLAIV) in HIV-infected Children and Young Adults

Summary: The goal of this study is to determine if there is a difference in shedding (primary objective) and in immunogenicity and safety (secondary objectives) between HIV-positive and HIV-negative children and young adults who are receiving the quadrivalent live-attenuated influenza vaccine (QLAIV).
Inclusion criteria: inclusion criteria:

 Age 2-25

 Only supposed to get one dose of vaccine for upcoming influenza season

 No viral respiratory symptoms at time of immunization

 HIV-infected group: must have:

 HIV-infection documented by 2 tests such as positive serology, positive HIV DNA or positive HIV RNA;

 must thave a CD4>25% or 500, or

 must have CD4>15% or 200 and be on HAART

 Healthy controls: no major medical problems affecting the immune system

 Recruited among:

 HIV-unifected clients of the Children's Immunodeficiency Program(CHIP),

 Children's Hospital Colorado Child Health Clinic and Adolescent Clinics.

Exclusion criteria: :

 History of:

 reactive airway disease,

 recurrent wheezing, or

 asthma

 Active wheezing at time of immunization

 On any antiviral agents active against influenza (amantadien/rimantadine, zanamavir, oseltamivir) at time of immunization or planned over 21 days of shedding collection

 Receipt of IVIG within 3 months prior to enrollment

 Plan to receive IVIG during the 4 weeks after immunization

 Moderate to severely immunocompromised individual living in the home

 Pregnant

 Breastfeeding

 Plan to start immunosupressive medications or stop HAART over the 4 weeks following immmunization

 Temperature > 100F or 37.8C

 Rhinorrhea or cough not related to allergies at the time of immunization

 History of fungal sinusitis

 History of Guillain-Barre Syndrome

 Current on antibiotics

 Currently taking aspirin

 On an investigational drug at the time of immunization or planned over the 28 days of shedding collection

 On any experimental medication at time of immunization or planned over 21 days of shedding collection

['Quadrivalent Live Attenuated Influenza Vaccine']


Prospective Memory in Children With Traumatic Brain Injury

Summary: Prospective memory (PM) is memory to complete future tasks, such as recalling to give a note to someone when you next see them, pick up milk on the way home, or remembering to keep an appointment. This study will evaluate PM in children with traumatic brain injury (TBI).
Inclusion criteria: inclusion criteria

 English speaker

 Minimum birth weight of 2500 grams (5.5 lbs) and 37 weeks' gestation

 Additional inclusion criteria for Children with Traumatic Brain Injury

 Head injury resulting in a post-resuscitation Glasgow Coma Scale score of either 13 to 15 or 3 to 8

 No evidence of hypoxic injury

Exclusion criteria:

 History of epilepsy, mental retardation, or documented evidence of developmental dysfunction

 Previous hospitalization for head injury involving loss of consciousness or post-concussional symptoms

 History of autism, major psychiatric disorder, or pervasive developmental delay

 History of meningitis or encephalitis

 History of child abuse

 History of chronic or uncontrolled serious physical disorders (cancer, uncontrolled diabetes, cystic fibrosis, etc.)

 Note: siblings of participants with TBI or orthopedically-injured comparison children will not be enrolled to maintain the independence of the groups