Evaluation of ST2 and IL-33 in Patients Presenting to the Emergency Department With Trouble Breathing

Summary: Trouble breathing (dyspnea) is a nonspecific symptom associated with many diseases such as chronic obstructive pulmonary disease (lung disorder in which the flow of air to the lungs is blocked), asthma, pneumonia, pulmonary hypertension (high blood pressure in the lungs), congestive heart failure (fluid build-up in the lungs because the heart is not pumping normally) and pulmonary embolism (blood clot in the lungs). The purpose of this study is to test two blood markers called ST2 and IL-33. Blood markers are proteins or other compounds in your blood that physicians use to diagnose different diseases and to determine what the course of an illness will be. In preliminary research studies, ST2 and IL-33 have been elevated in patients with a wide variety of diseases where the lungs are the primary organs involved. This research study will further investigate the ability of ST2 and IL-33 to predict the severity of disease and the possible use of ST2 and IL-33 in the diagnosis of various lung diseases.
Inclusion criteria: inclusion criteria:

 Presenting to the Emergency Department with signs and symptoms of dyspnea (short of breath, tachypnea, hyperventilation, etc) within the last 24 hours

 Normal cardiac output as measured by noninvasive bioimpedance

 Greater than or equal to 18 years of age

 Patient or legal representative willing and able to provide informed consent and comply with study procedures

Exclusion criteria: :

 A history of congestive heart failure and a BNP > 500pg/mL (or NTproBNP > 900pg/mL) if obtained by the treating physician

 Treating physician suspects patient has new onset congestive heart failure

 ECG changes diagnostic of acute myocardial ischemia/infarction

 Ischemic chest pain within the prior 24 hours by history

 Obvious chest trauma

['Chronic Obstructive Pulmonary Disease', 'Asthma', 'Pulmonary Embolism', 'Pneumonia', 'Pulmonary Hypertension']

Chronic Obstructive Pulmonary Disease
Asthma
Pulmonary Embolism
Pneumonia
Pulmonary Hypertension


Acute Viral Hepatitis and Diabetes Mellitus

Summary: It has been observed that several of patients having prolonged or complicated course of acute viral hepatitis have underlying diabetes. It is possible that with impaired hepatocyte regenerating capacity, these patients run a more prolonged and complicated course.~We hypothesize that acute hepatitis infection has a prolonged and complicated course among diabetic patients.
Inclusion criteria: inclusion criteria:

 All patients between the ages of 18 to 70 years

Exclusion criteria: :

 Recent intake of drugs known to cause acute hepatitis

 History of alcohol ingestion >40mg/day

 Suspected ischemic hepatitis

 Illness causing acute hepatitis such as Malaria hepatits, enteric hepatitis, Leptospirosis, septecemia

 HIV.

 Associated co morbidities, which can affect survival such as cardiovascular disease and diabetic nephropathy.

 Recent intake of drugs known to cause acute hepatitis

 History of alcohol ingestion >40mg/day

 Suspected ischemic hepatitis

 Malaria hepatits, enteric hepatitis, Leptospirosis, septecemia

 Co infection with HIV.

 Comorbidities which affect survival such as CAD and diabetic nephropathy.

 Gestational diabetes

 Pregnant female

 Cirrhosis

['Acute Viral Hepatitis', 'Diabetes Mellitus']


Adolescent Trauma Recovery and Stress Disorders Collaborative Care (ATRSCC) Model Program Trial

Summary: Recent needs assessments suggest that difficulties exist in care coordination between emergency medical services (EMS) systems and primary care for injured adolescents with alcohol problems and post-traumatic stress disorder (PTSD). This project will implement, evaluate, and disseminate the adolescent trauma support service model program that aims to enhance coordination between EMS systems and primary care/community services.
Inclusion criteria: inclusion criteria:

 The investigators will screen all English speaking female and male adolescents ages 12-18, who present to Harborview Medical Center with injuries so severe that they require inpatient admission and/or > 24 hour observation in the emergency department.

 All dyads where both parents consent and adolescents assent to the study will be enrolled in the study and randomized.

Exclusion criteria: :

 Adolescents who have suffered head, spinal cord, or other severe injuries that prevent participation in the baseline interview will be excluded from the protocol.

 Patients who require immediate intervention (e.g., self-inflicted injury, active psychosis, mania, and victims of family abuse) will be excluded and referred to the Harborview Inpatient Psychiatric Consult Service.

 Patients who are currently incarcerated or are likely to face criminal charges will be excluded.

['Post-traumatic Stress Disorder', 'Alcohol Abuse', 'Alcohol Dependence']

Post-traumatic Stress Disorder
Alcohol Abuse
Alcohol Dependence


The Reduction of Systemic Lupus Erythematosus Flares :Study PLUS

Summary: The main objective of study PLUS is to determine the potential benefits of individualized HCQ dosing schedules aimed at maintaining the whole-blood HCQ concentration above 1000 ng/ml
Inclusion criteria: inclusion criteria:

 Age of 18 and above

 Diagnosis of Systemic Lupus Erythematosus (SLE) according to the American College of Rheumatology (ACR) Classification Criteria.

 Treatment with HCQ for at least 6 months, without modification of HCQ dosage for 2 months

 Stable dosage of HCQ from one day to another (200 g x 2/day or 400 mg once a day or 200 mg once a day)

 No increase in the steroids dosage during the 3 previous weeks

 Steroids dosage lower or equal to 0. 5 mg/kg/day of prednisone equivalent

 No modifications of a possible immunosuppressor during the 2 previous months

 SELENA-SLEDAI < or = 12

 Signature of the consent of participation

Exclusion criteria: :

 Known retinopathy, present or passed

 Severe cataract obstructing the ophthalmologic monitoring

 MONOPHTALM patients

 Past history of intolerance with HCQ (in particular gastro-intestinal, or retinal) during the possible former use of a higher dosage

 Use of nivaquine during the 3 previous months

 Treatment with biotherapy (for example Rituximab) during the 12 previous months

 Calculated clearance of creatinin lower than 60 ml/min

 Chronic alcoholism

 Liver failure

 Desire of pregnancy in the next 7 months

 Known non compliance, and risks of random follow-up

 Absence of social security cover

 People profiting from a particular protection:

 Pregnant women

 Age under 18

 Patient under supervision and TRUSTEESHIP

 People who are hospitalized without their consent and not protected by the law

 People who are private of freedom.

 Criteria of inclusion at the visit of randomization (D0):

 All the patients responding to the next criterions can be randomized:

 Blood HCQ concentration ranging between 100 and 750 ng/ml at the time of the visit of preselection,

 No increase in the steroids dosage since last visit

 No modifications of a possible immunosuppressor since last visit

 SELENA-SLEDAI < or = 12 Activity of the lupus remaining stable (no increase of more than 2 points of the SELENA-SLEDAI),

 Ophthalmologic examination in the 6 previous months with no contra-indication for the use of HCQ,

 Absences of conductive disorders on the ECG

 Use of an effective contraception,

 Negative Beta-HCG.


A Study to Evaluate Safety and Tolerability of a Therapeutic Vaccine, ASP0113, in Subjects Undergoing Allogeneic Hematopoietic Cell Transplant

Summary: This study is to evaluate safety and tolerability of a therapeutic vaccine, ASP0113, in subjects undergoing allogeneic HCT. The occurrence of CMV viremia and immunogenicity are also assessed.
Inclusion criteria: inclusion criteria:

 Subject is planned to undergo either of the following:

 Sibling Donor Transplant - 7/8 Human Leukocyte Antigen (HLA)-A, -B, -C, -DRß1 match utilizing high resolution typing or 8/8 (HLA)-A, -B, -C, -DRß1 match utilizing low or high resolution typing.

 Unrelated Donor Transplant - 7/8 or 8/8 HLA-A, -B, -C, -DRß1 match utilizing high resolution typing.

 Subject has one of the following underlying diseases: Acute myeloid leukemia (AML) /Acute lymphoblastic leukemia (ALL) / Acute undifferentiated leukemia (AUL) /Acute biphenotypic leukemia / Chronic myelogenous leukemia (CML) / Chronic lymphocytic leukemia (CLL) / myelodysplastic syndrome(s) (MDS)

 Subject is scheduled to receive an allogeneic peripheral blood stem cell (PBSC) or bone marrow transplant (BMT) for the treatment of hematologic disorders

Exclusion criteria: :

 Subject has active CMV disease or infection or has received treatment for active CMV disease or infection within 90 days prior to transplant

 Subject has planned CMV prophylactic therapy with antiviral drugs or CMV-specific immunoglobulins

 Subject has a modified hematopoietic cell transplant comorbidity index (HCT-CI) score > 3

 Subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA)

 Subject has received any of the following substances or treatments:

 T-cell depletion of donor cell product.

 Alemtuzumab within 60 days prior to transplant, including conditioning regimen. Subjects for whom treatment with alemtuzumab is planned at any time from 60 days prior to through one year post-transplant should not be enrolled in the trial.

 Administration of a CMV vaccine, including any prior exposure to ASP0113.

 Subject has received an allogeneic stem cell transplant within one year prior to transplant

 Subject has a current malignancy in addition to the malignancy being treated for the study or the subject has a history of any other malignancy

 Subject has an unstable medical or psychiatric condition, including a history of illicit drug(s) or alcohol abuse that the Investigator believes will interfere with protocol requirements.

['Allogeneic Hematopoietic Cell Transplant']


Transitional Palliative Care in End-stage Heart Failure

Summary: Palliative care for end-stage organ failure patients has been included as one of the key programs to be implemented in 2011-2012 in the Hospital Authority, Hong Kong. Among all the disease groups, end-stage heart failure patients have the highest mortality rate. Patients at the end stage of heart failure have health concerns shared by other end-stage patients including cancer patients. Many guidelines, local and world-wide, have advocated a palliative approach of care for those heart failure patients who are at end stage. Studies have shown that end-stage heart failure patients tend to have frequent emergency room visits and repeated hospital admissions. Also, these patients suffer from a number of health problems that adversely affect their Quality Of Life.~There is scarcity of experimental studies informing practitioners which models work best for palliative patients in Hong Kong. There were randomized controlled trials conducted outside Hong Kong which suggest multidisciplinary approach of palliative care is possible to reduce readmissions but evidence is not present for other outcomes such as symptom control and carer burden.~In an attempt to fill knowledge gap and inform practice using evidence, this study is launched to compare the effects of a customary hospital-based palliative heart failure care and an interventional Home-based Palliative heart failure Program.~Hypothesis~there is no difference in health care utilization for end-stage heart failure patients between the customary hospital-based group and the Home based palliative heart failure program group~there is no difference in evaluated health outcomes (functional status, symptom intensity, and satisfaction with care) between the customary hospital-based group and the Home based palliative heart failure program group~there is no difference in perceived health outcomes (quality of life, caregiver burden) between the customary hospital-based group and the Home based palliative heart failure program group~there is no difference in cost effectiveness between the customary hospital-based group and the Home based palliative heart failure program group~there is no difference In patients' lived experiences between the customary hospital-based group and the Home based palliative heart failure program group
Inclusion criteria: inclusion criteria:

 Ability to speak Cantonese

 Living within the hospital service area

 Ability to be contacted by phone

 Identified as end-stage heart failure eligible for palliative care, guided by Prognostic Indicator Guidance, National Gold Standards Framework,to fulfill at least two of the indicators below:

 (i) Congestive heart failure New York Heart Association stage III or IV (ii) Patient thought to be in the last year of life by the care team (iii) Repeated hospital admissions with symptoms of heart failure (3 hospital admissions within one year) (iv) Existence of physical or psychological symptoms despite optimal tolerated therapy

Exclusion criteria: :

 Discharged to nursing home or other institution

 Inability to communicate

 Diagnosed with severe psychiatric disorders such as schizophrenia, bipolar disorder

['Transitional Care Model', 'Usual care']

['End Stage Heart Disease', 'Heart Failure']


Prospective Validation of Clini-biological Parameters Including Initial Hemostasis, Which Improve the Prediction of Death at 1 Month Among Patients With Septic Shock

Summary: A prognostic score was proposed by the investigative team to predict death at 1 month. This score is based on certain biological markers, scored under emergency conditions in the first 24 hours of routine clinical practice management for septic shock.~The main objective of this multicenter study is to validate the performance of the score in terms of area under the ROC curve and negative predictive value.
Inclusion criteria: inclusion criteria:

 patient (or representative) received the information notice

 patient has hemodynamic insufficiency of non-traumatic or cardiogenic origin associated with severe sepsis (treated with Noradrenalin) and organ dysfunction, hypoperfusion or hypotension

 body temperature > 38.3°C or < 36°C

 heart rate > 90 bpm

 Tachypnea > 20 C/min or PaCO2 < 32 mmHg or mechanical ventilation

 leukocytes > 12000 µL-1 ou < 4000 µL-1 ou > 10% immature forms

 oliguria < 0.5 ml/kg/h for at least 2 hours

 abrupt alteration (24 h) of conscienceness

 thrombocytopenia < 100 000 G/L or disseminated intravascular coagulation

 mottled skin and / or capillary refill time> 3 sec

 PaO2/FiO2 < 300 mmHg ou < 40KPas

 Lactatemia > 2mMol/l

 septic shock: Systolic Blood Pressure (SBP) > 90 mmHg or need for vasopressors to maintain SBP> 90 mmHg despite a prior filling (20-30 ml / kg of macromolecules or 40 to 60 ml / kg of normal saline (or decrease in SBP> 40% in the hypertensive)

Exclusion criteria: :

 patient is dying or limitation or cessation of active treatment

 patient is already included in another trial

 patient or family refusal

 patient not affiliated with a social security system


Anakinra and Kawasaki Disease

Summary: The study is designed to assess the efficacy and safety of anakinra, an interleukin 1 receptor antagonist, in patients with Kawasaki disease who failed to respond to standard treatment:e.g. one infusion of 2g/kg of intravenous immunoglobulins.
Inclusion criteria: inclusion criteria:

 Patients, male and female, at any age ≥ 3 months (5 kg) of life, with KD according to the American Heart Association definition for complete or incomplete KD. fever ≥ 5 days and ≥ 4 of 5 main clinical signs: modification of the extremities, polymorphic exanthema, bilateral bulbar not exudative conjunctivitis, erythema of the lips or oral cavity, and cervical lymph nodes usually unilateral > 1.5 cm in diameter. In the presence of less than 4 clinical criteria and 5 days of fever, the diagnosis of disease KD is proposed in case of coronary abnormalities (at least one dilated coronary artery with internal diameter ≥ 2,5 SD from the mean normalized for body surface area (Z score) as determined by echocardiography. For indicative purpose, in case of incomplete KD, other biological supportive criteria for incomplete KD can help to ensure the diagnosis: leucocytosis, elevated CRP, elevated ESR, anaemia, hyponatremia, elevated ASAT, ALAT and gGT, hyperlipidaemia.

 Patients who failed to respond to standard therapy of KD:, e.g. Persistence or recrudescence of fever ≥ 38°C, 48 hours after the infusion of 2g/kg of IV Ig,

 Weight ≥5Kg

 Patient, parent or legal guardian's written informed consent is required

 Patient with health insurance

 Patient agrees to have effective contraception for the duration of participation in the research

Exclusion criteria: :

 Preterm and neonates, pregnancy

 Patients suspected with another diagnosis

 Patients with overt concomitant bacterial infection

 Patients previously treated with another biotherapy

 Patients with any type of immunodeficiency or cancer

 Patients with increased risk of TB infection

 Recent tuberculosis infection or with active TB

 Close contact with a patient with TB

 Patients recently arrived less than 3 months from a country with high prevalence of TB

 A chest radiograph suggestive of TB

 Patients with end stage renal disease: NKF stages ≥4; eGFR≤29mL/min/1.73 m2 or diabetes mellitus or neutropenia <1500/mm3 or liver failure

 Hypersensitivity to the active substance or to any of the excipients (citric acid and anhydrous; sodium chloride disodium edetate dehydrate polysorbate 80; sodium hydroxide; water for injections)

 Patient already included in a biomedical research other than observational (e.g.; cohort, registry)


Sensory Changes From Chest Drains

Summary: Does chest drains contribute to the post thoracotomy pain syndrome
Inclusion criteria: inclusion criteria:

 Age > 18

 Able to cooperate

 able to speak and read Danish

Exclusion criteria: :

 repeat surgery

 cognitive dysfunction

 other nerve injury on the thorax

 abuse (medicine/ alcohol etc)


Watchful Waiting Versus Repair of Oligosymptomatic Incisional Hernias

Summary: Watchful waiting is non-inferior to surgical repair of asymptomatic and oligosymptomatic incisional hernias in terms of pain and discomfort during normal activities.
Inclusion criteria: inclusion criteria:

 age ≥18 years

 asymptomatic/ oligosymptomatic incisional hernia

Exclusion criteria: :

 no hernia detectable by physical examination

 acute incarcerated hernia

 emergency hernia repair

 pain or discomfort associated with the hernia during normal activities

 local or systemic infection

 ASA score >3

 inability to complete or comprehend the preoperative questionnaire

 repair with biologic prothesis


Valsartan in Elderly Isolated Systolic Hypertension Study

Summary: The aim of this study is to compare the incidence of cardiovascular events between two target systolic blood pressure levels, below 140 mmHg and below 150 mmHg under treatment with valsartan in elderly isolated systolic hypertensive patients in Japan.
Inclusion criteria: inclusion criteria:

 Outpatients aged over 70 years and less than 85 years, regardless of sex.

 Patients with stable seated systolic blood pressure of over 160 mmHg and diastolic blood pressure of less than 90 mmHg at two visits within 2 to 4 weeks.

 Previously untreated patients or patients who are on other therapy that can be converted to valsartan.

Exclusion criteria: :

 Patients with secondary hypertension or malignant hypertension.

 Patients with seated systolic blood pressure of over 200 mmHg.

 Patients with seated diastolic blood pressure of over 90 mmHg.

 Patients with a history of cerebrovascular disorder or myocardial infarction within 6 months prior to enrolment in the study.

 Patients who underwent coronary arterioplasty within 6 months prior to enrolment in the study or patients who will undergo coronary arterioplasty within 6 months after entry.

 Patients with severe heart failure (NYHA functional classification III and IV).

 Patients with severe aortic stenosis or valvular disease.

 Patients with atrial fibrillation, atrial flutter, or serious arrhythmia.

 Patients with renal dysfunction with serum creatinine level of over 2 mg/dL.

 Patients with serious liver dysfunction.

 Patients with a history of hypersensitivity to valsartan.

 Other patients who are judged to be inappropriate for the study by the investigator or sub-investigator.


Influence of Sulindac and Probiotics on the Development of Pouch Adenomas in Patients With Familial Adenomatous Polyposis

Summary: The purpose of this study is to determine whether sulindac and VSL#3 - inulin, either combined or alone, are effective in treating or preventing adenoma development in the ileal anal pouch in patients with familial adenomatous polyposis.
Inclusion criteria: inclusion criteria:

 Clinically or genetically proven familial adenomatous polyposis

 Restorative proctocolectomy with ileal pouch anal anastomosis

Exclusion criteria: :

 Chronic or acute renal or hepatic disease

 History of oesophageal, gastric or duodenal ulcers

 Known hypersensitivity to sulindac

 Daily use during the last three months of:

 Aspirin

 Non-Steroidal Anti-Inflammatory Agents

 Probiotics

['Sulindac (drug)', 'VSL#3 (probiotic)', 'Inulin (probiotic)']

Sulindac (drug)
VSL#3 (probiotic)
Inulin (probiotic)


Case Management Alternatives for African American Women at High Risk for HIV

Summary: The purpose of this study is to test two innovative case management approaches designed to increase linkages and engagement with drug abuse treatment, HIV-related care, and other health services among an underserved population of African American women at risk for HIV.
Inclusion criteria: inclusion criteria:

 Current substance abuse

 Current high-risk sexual behavior

 African American racial identification

Exclusion criteria: :

 Non resident of Miami-Dade county


Renal Denervation in Patients With Heart Failure and Severe Left Ventricular Dysfunction.

Summary: It is a randomized prospective controlled study evaluating the effect of transcatheter renal denervation on the clinical status of patients with chronic heart failure and its safety procedures. The working hypothesis of the study is that by performing transcatheter renal denervation in patients with chronic heart failure and severe left ventricular systolic dysfunction there will a resultant reduction in the renal sympathetic activation which in turn will reduce the number of hospitalizations and deaths from heart failure.
Inclusion criteria: inclusion criteria:

 Patients over 18 years of age with chronic heart failure, ischemic and non-ischemic etiology.

 NYHA (New York Heart Association) class II-IV.

 LVEF (Left Ventricular Ejection Fraction) ≤ 35%.

 Patients treated with maximum tolerated doses of standard pharmacotherapy for heart failure, who were stable for at least four weeks without acute decompensated heart failure.

 Prior to enrollment, patients must give informed consent.

Exclusion criteria: :

 Patients with history of acute coronary syndrome or stroke within the last 6 months.

 Significant valvular defects and/or planned cardiac surgery.

 Systolic blood pressure <110 mmHg.

 Advanced renal insufficiency (estimated GFR (Glomerular Filtration Rate) according to MDRD <30 ml/min/1.73 square meters).

 Unsuitable anatomy of renal arteries (presence of significant renal stenosis, renal artery narrower than 4 mm).

 Patients who underwent renal angioplasty or stent placement into the renal artery in the past.

 Severe coagulation disorders.

 Pregnancy or lactation.

 Refusal of the patient.

 Other diseases limiting prognosis of the patient to less than 2 years.

 Other reasons which in the opinion of the attending physician would preclude the individual from participating in the study.


Retrospective Database Study of Real World Abilify Outcomes in Major Depressive Disorder (MDD)

Summary: To examine the differences in health care utilization and costs between MDD patients on adjunctive aripiprazole therapy and MDD patients on other augmentation therapies.
Inclusion criteria: inclusion criteria:

 ≥1 fill for an augmentation therapy medication from Table 1 during the identification period of 01 January 2005 - 30 November 2008.

 12 months of continuous enrollment with medical and pharmacy benefits each before the index date (pre-index period) and after the index date (post-index period).

 ≥1 medical claim with a primary International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) diagnosis for MDD (296.2x, 296.3x, 311.xx) during the pre-index period.

 Age ≥18 years as of the year of the pre-index period.

Exclusion criteria: :

 No pharmacy claims for atypical antipsychotics, mood stabilizers, anxiolytics, anticonvulsants, or stimulants, during the pre-index period.

 No medical claims with primary or secondary diagnoses for non-MDD episodic mood disorders or schizophrenia during the pre-index or post-index periods.


Diagnosis of Invasive Pulmonary Aspergillosis (IPA) in Critically Ill Patients

Summary: Invasive pulmonary aspergillosis (IPA) is difficult to diagnose and remains a cause of high morbidity and mortality in critically ill patients in the ICU. Accepted diagnostic protocols for haemato-oncological patients are not applicable for critically ill patients in ICUs. Definitive discrimination between aspergillic colonisation and IPA often depends on the clinical experience of the treating physician, evaluating clinical signs, co-morbidities, and course of the disease. Life saving treatment with the first line antimycotic Voriconazol (Vfend®) can only be initiated after diagnosis of IPA.~In this prospective clinical trial the investigators aim to structure, optimize and fast track the diagnostic pathway of IPA in critically ill patients treated in our ICU-department.
Inclusion criteria: inclusion criteria:

 > 18 years

 positive aspergillus culture in respiratory tract sample OR

 positive aspergillus galactomannan in respiratory tract sample

Exclusion criteria: :

 no inform consent

 age < 18 years

['Survival After IPA', 'Risk Factors for IPA']


Transumbilical Single Incision Versus Conventional Three Incisions Laparoscopic Appendicectomy

Summary: Laparoscopic appendicectomy is widely practiced in Hong Kong nowadays with shorter hospital stay and less wound complications. Most of the time, three small wounds of less than 10mm will be adequate enough for the completion of the surgery with minimal pain.~Recently, the concept of Natural Orifice Transluminal Endoscopic Surgery (N.O.T.E.S) led to the attention of single incision laparoscopic surgery (SILS) again in the surgical community. SILS is not a new idea. The first SILS for cholecystectomy was reported in 1997 by Navarra et al. However, the close proximity of the instruments, limitation in triangulation during dissection and suboptimal exposure of the surgical field has made this approach unpopular in last decade. Because the concept of N.O.T.E.S and the newly designed access port, surgeons are now focused again on SILS. The Chinese University of Hong Kong has recently release their preliminary results on the use of SILS on appendicectomy with satisfactory results in terms of less post-operative pain and less prominent scar. However, it was a case series with limited number of patients. In order to test the advantages of SILS on the management of patients with acute appendicitis, a double blinded randomized clinical trial is conducted.
Inclusion criteria: inclusion criteria:

 Patients will be at least 18 years of age.

 Male or female (excluding pregnant females).

 Patients with ASA ≦ 3.

 Patients informed about the study, and will have read; understood and signed the patient informed consent. Patients will be willing and able to submit to postoperative follow-up evaluations.

Exclusion criteria: :

 Patients have previous history of abdominal surgery.

 Patients with ASA > 3.

 Patients with any conditions that were not suspected preoperatively and are only discovered at the time of the operation.

 Patients who are incompetent in giving consent.

['transumbilical single incision laparoscopic appendicectomy', 'conventional laparoscopic appendicectomy']


Smoking Cessation in Patients With COPD (SMOCC) in General Practice

Summary: Background: Smoking cessation is the key element in the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). The role of the general practice in assisting these patients with successful quitting smoking was suboptimal. Therefore we evaluated the effectiveness of two smoking cessation programs (counseling and nicotine replacement) for smokers with COPD in routine general practice, one with (CNB) and one without (CN) the combination with bupropion-SR, compared to usual care (UC) and explored the role of COPD symptoms in successful smoking cessation.~Method: RCT with 667 patients with COPD, 68 general practices were randomly allocated. The usual care group (UC) consisted of 148 patients (22 practices), the first intervention group (counseling plus nicotine replacement (CN) of 243 patients (21 practices) and the second intervention group of 276 patients (25 practices. Main outcome measure was (biochemically verified) point prevalence.
Inclusion criteria: inclusion criteria:

 A software program using Anatomical Therapeutical Chemical (ATC) prescription codes and International Classification of Primary Care (ICPC) diagnosis codes selected potential patients with COPD. Criteria: age >35 years and a diagnosis recorded as COPD or as ICPC code R95/96, or a prescription of at least three times of bronchodilators (ATC code R03a/bc) and/or prescription of at least two times of inhaled anti-inflammatory medication in the past year (ATC code R03). General practitioners (GPs) had to confirm the diagnosis of the selection. Patients were eligible to participate if they met the following criteria:

 Current smoking

 Suffering from COPD according to the GP's diagnosis

 In command of the Dutch language.

Exclusion criteria: :

 Too ill

 Under control of a chest physician

 Serious physical or psychological comorbidity

['Counseling and Nicotine replacement (CN)', 'Counseling, Nicotine replacement and Bupropion (CNB)']

['Chronic Obstructive Pulmonary Disease (COPD)']


Safety and Immunogenicity of Two Intradermal Rabies Vaccine Regimens Administered With and Without Human Rabies Immunoglobulin in Subjects ≥ 1 Years of Age

Summary: Demonstrate non-inferiority of the immune response between new versus the currently recommended intradermal regimens of rabies vaccine when administered with or without rabies immunoglobulins in healthy subjects ≥ 1 years of age.
Inclusion criteria: inclusion criteria:

 Healthy males and females ≥ 1 years of age

 Individuals/ individual's parents or legal guardians who have given written consent

 Individuals in good health

 Individuals who can comply with study procedures

Exclusion criteria: :

 Behavioral or cognitive impairment or psychiatric disease.

 Unable to comprehend and to follow all required study procedures for the whole period of the study.

 History of illness or with an ongoing illness that may pose additional risk to the individual if he/she participates in the study.

 Individuals ≥ 1 to ≤ 17 years of age, who have or ever had a malignancy.

 Individuals ≥ 18 years of age, who have or who within the last 5 years, have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder.

 Known or suspected impairment of the immune system (including but not limited to HIV, autoimmune disorders, immunosuppressive therapy as applicable).

 Female of childbearing potential who has not used any of the acceptable contraceptive methods for at least 2 months prior to study entry.

 Female of childbearing potential, refusal to use an acceptable birth control method through day 50.

 Female of childbearing potential, with a positive pregnancy test prior to enrollment.

 Received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the previous 12 weeks.

 Allergic to any of the vaccine components.

 Allergic to any of the human rabies immunoglobulin components.

 Contraindication or precaution against rabies vaccination.

 Contraindication or precaution against man rabies immunoglobulin administration.

 Planning to receive anti-malaria medications (e.g. Mefloquine) 14 days prior to day 1 vaccination through day 50.

 Participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.

 Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.

 Body temperature ≥ 38.0°C (≥ 100.4°F) within 3 days of intended study vaccination.

 Received rabies vaccines or rabies immunoglobulin or have been exposed to rabies.

 Part of the study personnel or immediate family members of study personnel conducting this study.

 Current or history of drug or alcohol abuse within the past 2 years.

['Rabies vaccine', 'Rabies vaccines + Rabies immunoglobulins', 'Rabies vaccine', 'Rabies vaccines + Rabies immunoglobulins']


Zolpidem CR and Hospitalized Patients With Dementia

Summary: The purpose of this research study is to compare the effectiveness of Zolpidem CR to that of placebo in improving sleep efficiency in people with dementia admitted to the hospital because of their symptoms. You can participate in this study if you have dementia of the Alzheimer's type or vascular dementia. This study involves placebo; a placebo is a tablet that looks exactly like Zolpidem CR, the study drug, but contains no active study drug. We will use placebos to see if the study results are due to the study drug or due to other reasons. Zolpidem CR is also called Ambien CR and is widely available by prescription. Zolpidem CR is approved by the U.S. Food and Drug Administration (FDA) for the short-term treatment of insomnia (trouble falling or staying asleep).
Inclusion criteria: inclusion criteria:

 Age between 60-99 years

 Clinical diagnosis of Dementia of the Alzheimer's type or Vascular Dementia

 Only subjects with Mini Mental Status Examination scores of greater or equal to 10 will be enrolled.

Exclusion criteria: :

 Subjects who are too agitated to be able to wear the activity monitors;

 Subjects who are actively suicidal or homicidal or for whom the clinical treatment team considers participation in the study to be unsuitable;

 Subjects with untreated primary sleep disorders;

 Subjects who receive hypnotic medications during their participation in the study; Subjects who received hypnotic medications prior to enrollment may participate in the study if they agree to stop receiving hypnotic medications (with their attending physician's approval);

 Subjects who are receiving over the counter sleep aids;

 Subjects who can not commit to abstaining from alcohol use while in the study;

 Subjects with known anaphylactic reaction or angioedema with Zolpidem CR.

['Dementia', 'Alzheimer Disease', 'Dementia, Vascular', 'Sleep Disorders', 'Circadian Dysregulation']

Dementia
Alzheimer Disease
Dementia
Vascular
Sleep Disorders
Circadian Dysregulation


Effect of Montelukast on Basophils, In-vitro

Summary: Subjects with either allergic asthma or allergic rhinitis will be recruited to obtain blood. This blood will be used to be stimulated with to whatever the patient allergic. In the laboratory, this stimulated blood will be measured for histamine, leukotrienes, IL-13 and IL-3. These are chemicals responsible for allergy symptoms.
Inclusion criteria: inclusion criteria:

 Allergic asthma or allergic rhinitis

 age 12+

Exclusion criteria: :

 smokers

['Allergic Asthma', 'Allergic Rhinitis']


Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms

Summary: This trial is conducted in North America. The purpose of this study is to determine if Vagifem Low Dose is an effective and safe treatment for patients suffering from postmenopausal atrophic vaginitis.
Inclusion criteria: inclusion criteria:

 Postmenopausal women whose last menstruation was at least two years previously
Exclusion criteria:

['Menopause', 'Postmenopausal Vaginal Atrophy']

Menopause
Postmenopausal Vaginal Atrophy


Treatment of Aspergillus Fumigatus (a Fungal Infection) in Patients With Cystic Fibrosis

Summary: This clinical trial will attempt to determine whether we can improve clinical outcomes for patients with cystic fibrosis who are infected with a fungus called Aspergillus fumigatus.
Inclusion criteria: inclusion criteria

 Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride greater than 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations

 Patient must be known to be chronically colonized with Aspergillus fumigatus.

 Patients must be clinically stable at randomization, no use of new inhaled, oral or intravenous antibiotics or oral or intravenous corticosteroids during the 14-day period prior to randomization.

 6 years of age and older

 Patients must weigh at least 20 kg

 Post-menarche females must be using an effective form of contraception.

Exclusion criteria:

 Inability to give informed consent.

 Respiratory culture positive for B.cepacia complex

 Renal function abnormalities-Creatinine greater than 1.5 times upper limit of normal within a 30 day period prior to randomization

 Liver function abnormalities : AST or ALT greater or equal to 2.5 times the upper limit of normal within a 30 day period prior to randomization

 Neutropenia, absolute neutrophil count< or = 1000 within a 3-day period prior to randomization

 History of biliary cirrhosis documented by liver biopsy or imaging.

 History of portal hypertension.

 Investigational drug use within 30 days of randomization date.

 History of alcohol, illicit drug or medication abuse within 1 year of randomization.

 Women who are pregnant, breastfeeding or trying to conceive


Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with or without radiation therapy in treating patients who have esophageal cancer.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Histologically confirmed adenocarcinoma, squamous cell, adenosquamous, or undifferentiated carcinoma of the esophagus or gastroesophageal junction

 Potentially resectable disease

 No malignant celiac node involvement

 No cervical esophageal carcinoma

 PATIENT CHARACTERISTICS:

 Age:

 18 and over

 Performance status:

 ECOG 0-2

 Life expectancy:

 Not specified

 Hematopoietic:

 Absolute neutrophil count at least 1,800/mm^3

 Platelet count at least 100,000/mm^3

 Hepatic:

 Bilirubin no greater than 1.5 times upper limit of normal (ULN)

 AST no greater than 3 times ULN

 Renal:

 Creatinine no greater than 1.5 mg/dL OR

 Creatinine clearance at least 60 mL/min

 Other:

 No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

 No significant medical or psychiatric illness that would preclude study

 Not pregnant or nursing

 Fertile patients must use effective contraception during and for at least 3 months after study

 PRIOR CONCURRENT THERAPY:

 Biologic therapy:

 Not specified

 Chemotherapy:

 No prior chemotherapy for esophageal cancer

 Endocrine therapy:

 Not specified

 Radiotherapy:

 No prior thoracic radiotherapy

 Surgery:

 See Disease Characteristics

 No prior surgical resection of esophageal tumor
Exclusion criteria:

['cisplatin', 'fluorouracil', 'paclitaxel', 'conventional surgery', 'neoadjuvant therapy', 'radiation therapy']

cisplatin
fluorouracil
paclitaxel
conventional surgery
neoadjuvant therapy
radiation therapy


Leflunomide in Systemic Lupus Erythematosus

Summary: A pilot study to evaluate the efficacy and safety of leflunomide in SLE patients with active disease who are refractory to cyclophosphamide
Inclusion criteria: inclusion criteria:

 Fulfill the revised ACR criteria for SLE with either evidence of active disease according to SLE Disease Activity Index (SLEDAI)

Exclusion criteria: :

 Patients who are pregnant or nursing women, or those with life threatening disease

 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Ischemic Preconditioning of Liver in Cadaver Donors

Summary: The long-term goals of this proposal are to develop clinical protocols of donor preconditioning to improve liver graft function and ameliorate complications of poor graft function after liver transplantation. Achievement of these objectives would improve liver recipient outcomes, increase utilization of livers and alleviate the current critical shortage of livers for transplantation. More stringent liver donor selection intended to decrease the complications of poor graft function conflicts directly with efforts to maximize the use of donor livers. Ischemic preconditioning (IPC) of liver attenuates hepatic ischemia reperfusion injury (IRI) in animals. Preliminary data show hepatic IPC effectively decreases IRI following hepatic resection in humans.~The specific aims of this project are: AIM 1: To test the hypothesis that 10 minutes of hepatic ischemic preconditioning in deceased donors would improve liver graft function and decrease injury in the early post transplant period. AIM 2: To test the hypothesis that ischemic preconditioning of deceased donor livers would decrease systemic inflammatory response in liver recipients in the early post transplant period. AIM 3: To examine whether ischemic preconditioning of deceased donor livers decreases early post transplant pulmonary edema and acute rejection and shortens hospital stay.
Inclusion criteria: inclusion criteria:

 - Deceased donor livers allocated to adult (> 18 years of age) recipients at the research site.

Exclusion criteria: :

 Deceased donor livers allocated to recipients at centers other than the research site.

 Deceased donor livers allocated to recipients < 18 years of age at the research site.

 Non-heart beating donors

 Deceased liver and small intestine donors

 Live liver donors.


The IMAP Study Improving Management of Mildly Abnormal Pap Smears

Summary: The study compares the psychosocial outcomes of different management strategies for women with minor atypia (including 'HPV effect') detected on Pap smears: conventional management (a repeat Pap smear at 6 months) versus Human papillomavirus (HPV) DNA testing, a new method proposed for the management of minor atypia and the informed choice of either management supported by a decision aid.~The study examines women's informed preferences for each of these options and compares the psychosocial outcomes in women who are or are not given the choice of management.~HPV DNA testing offers considerable changes to the management of women with minor atypia and there is evidence from the USA which suggests that the use of HPV DNA testing as a triage strategy is effective for women within this group (Solomon et al 2001). The introduction of HPV DNA testing may bring both benefits and harms to women. These harms and benefits are not well understood. Examination of the psychosocial outcomes of HPV DNA testing compared to conventional management and women's preferences for each is needed to guide decisions concerning HPV DNA testing in cervical screening in Australia and also internationally.
Inclusion criteria: inclusion criteria:

 Women with ONLY the following results on a routine Pap smear:

 Low grade epithelial abnormality;

 Minor changes in squamous cell;

 Minor changes in squamous cells with appearances consistent with Papillomavirus

 Women aged between 18-70 years

Exclusion criteria: :

 Women who are pregnant or planning to become pregnant in the next 12 months

 Women with previous Pap smear abnormality for 2 years.

['HPV DNA testing', 'Conventional management (repeat Pap smear at 6 months)', 'Decision aid with choice of management']


Web-Based Adolescent Motivational Enhancement Study

Summary: The proposed study is a randomized controlled trial that compares the effectiveness of an electronic personalized health screening app incorporating motivational feedback (i.e. Check Yourself) to usual care among moderate to high risk alcohol users. The purpose of this study is to determine whether Check Yourself is more effective than usual care in reducing alcohol consumption and binge drinking and improving quality of care among adolescents receiving school-based health clinic services.
Inclusion criteria: inclusion criteria:

 Eligible individuals will be 13-18 years old who are able to read and comprehend English.

 Participants who indicate alcohol use consistent with moderate to high risk on the Check Yourself App.

Exclusion criteria: :

 Individuals will be excluded from the study if:

 They do not meet age requirements

 Do not have a study visit at a participating school-based health clinic

 Lack the means to complete follow-up interviews (i.e. have neither telephone or internet access)

 Are not able to read or comprehend English

['Alcohol Risk Behaviors', 'Health Care Services Quality of Care']

Alcohol Risk Behaviors
Health Care Services Quality of Care


Early Functional Return to Work Following Distal Biceps Repair

Summary: Distal biceps ruptures occur most commonly among young males in their third and fourth decade of life. These injuries are becoming more common, however, as the aging population is remaining active through sport or labour demands. Distal biceps tears or ruptures follow a heavy eccentric load being placed on a shortened or flexed muscle, and often require surgical repair. Functionally, distal biceps injuries cause impairment as this portion of the muscle is largely responsible for supination and flexion at the elbow. Currently there is no consensus regarding post-operative immobilization protocols, and little evidence is available regarding timeframe for early return to functional activities. Existing evidence on functional outcomes post distal biceps tendon repair (DBTR) is of low quality with small sample sizes, and no known RCTs exist comparing early mobilization to immobilization on functional return. Reported timeframes for immobilization range from early controlled motion on day 1 post-operatively to complete immobilization for 6 weeks.~The primary study goal is to determine the effect of immobilization compared to unrestricted mobility post DBTR on early functional return to activities. It has been previously reported that those with DBTR related to a workers compensation injury returned to full duties in 3.95 months, while those with a non-workers compensation related injury returned to full work duties in 1.35 months. In Alberta, near 100 WCB claims were made for DBTR in both 2013 and 2014. Early mobilization of these repairs may allow an earlier return to modified and full work duties, thereby improving the functional quality of life of the individual as well as reducing the overall cost of disability payments.~This study will assess the 1) time to return to pre-injury work level and 2) time to return to modified duties among those who have no movement restriction post-repair and those who are splinted for 6 weeks. Re-rupture rates between groups will also be assessed as will strength, range of motion (ROM) and quality of life. These findings will assist in developing a standardized protocol for immobilization to optimize functional and clinical outcomes while expediting return to work.
Inclusion criteria: inclusion criteria:

 male subjects between 18 and 65 years of age

 patient has had a DBTR amenable to surgical repair

 surgeon must be able to obtain a tension-free repair using an endobutton.

 participants must have been working prior to the injury

 patient must be expected to return to work post-injury

Exclusion criteria: :

 females

 outside of the specified age range

 patient with an identified congenital abnormality at the insertion of the distal biceps tendon

 those who have previously ruptured the tendon or those with tendon ruptures resulting from a multi-trauma

 patients with psychiatric illness, cognitive impairment, or health conditions that preclude informed consent

 patients with life expectancy of less than 2 years

 patients who do not speak/read/understand English

 patients with no fixed address or contact information

 patients who are unwilling to complete follow-ups


Study to Investigate Sleep Apnea Patients at Altitude

Summary: The purpose of the study is to investigate the effect of an altitude sojourn on patients with the obstructive sleep apnea syndrome
Inclusion criteria: inclusion criteria:

 Obstructive sleep apnea syndrome based on symptoms and a sleep study

Exclusion criteria: :

 Sleep disorders other than obstructive sleep apnea syndrome

 Other than mild, stable cardiovascular disease

 Other than mild lung disease

 Chronic rhinitis, previous uvulopalatopharyngoplasty

 Treatment with drugs that affect respiratory center drive

 Internal, neurologic or psychiatric disease that interferes with sleep quality

 Previous intolerance to moderate or low altitude < 2600m


Amoxicillin/Metronidazole Based Quadruple Therapy for Helicobacter Pylori Eradication

Summary: No trial has examined the the efficacy of amoxicillin and metronidazole based quadruple therapy for Helicobacter pylori treatment. The study aims to compare the effectiveness and safety of 14-day amoxicillin-/metronidazole-based quadruple regiment and classical quadruple regiment for Helicobacter pylori eradication.
Inclusion criteria: inclusion criteria:

 Participants with non-investigated/functional dyspepsia or scarred peptic ulcer with indication of H pylori eradication treatment

 Ability and willingness to participate in the study and to sign and give informed consent

 confirmed H pylori infection by at least one of the following methods: C13-urea breath test, histology, rapid urease test or bacterial culture.

Exclusion criteria: :

 patients with peptic ulcer

 previous H. pylori eradication therapy

 Age below 18 years

 major systemic diseases

 previous gastric surgery

 pregnancy or breastfeeding

 allergy to any of the study drugs

 receipt of anti-secretory therapy, antibiotics or bismuth salts 4 weeks prior to inclusion

['Lansoprazole', 'Bismuth Potassium Citrate', 'Amoxicillin', 'Metronidazole', 'Clarithromycin']

Lansoprazole
Bismuth Potassium Citrate
Amoxicillin
Metronidazole
Clarithromycin


The Effect of Fish Oil in Major Depressive Disorder

Summary: The first part is a double-blind placebo-controlled trial to identify the effects of omega-3 polyunsaturated fatty acids (PUFAs) monotherapy in depression. The second part is a double-blind trial to identify the effects of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on different symptom clusters in patients with depression.
Inclusion criteria: inclusion criteria:

 DSM-IV criteria for major depressive disorder.

 Age being age 18-65.

 Capacity and willingness to give written informed consent.

Exclusion criteria: :

 Any major medical illnesses.

 A recent or past history of any Axis-I diagnoses besides major depressive disorder, including psychotic disorders; cognitively impaired mental disorders; impulse control disorders; substance use disorder or substance abuse (last 6 months prior to the studies); primary anxiety disorders, including post-traumatic stress disorder and panic disorder; and bipolar disorders; or Axis-II diagnoses, i.e. borderline and antisocial personality disorder.


Measurement of Hormonal Concentration in Chylothorax Fluid in Infants With Congenital Chylothorax

Summary: Late onset Hypothyroidism was found in infant with congenital hypothyroidism. The hypothesis is that infants with congenital hypothyroidism may lose thyroxin and other hormones via the chylothorax fluid causing transient hypothyroidism. In this study hormonal concentration will be measured in the chyle as well as hormonal serum level.
Inclusion criteria: inclusion criteria:

 Infants with congenital chylothorax requiring thorax drain

Exclusion criteria: :

 none


Salbutamol Tolerance Onset

Summary: Overuse of inhaled bronchodilator beta agonist medication results in a loss of effectiveness (i.e. tolerance). This has been shown for the short acting beta agonist salbutamol and the long acting beta agonist salmeterol. Tolerance to salmeterol is present within 24 hours. The onset of tolerance to salbutamol is not known.
Inclusion criteria: inclusion criteria:

 male or female

 18 to 65 years of age

 non smoker

 beta agonist naive for at least 14 days

 baseline FEV1 at least 70% predicted

 no respiratory tract infection or allergen exposure (if atopic) within 4 weeks of visit 1

Exclusion criteria: :

 poorly controlled asthma

 pregnant or lactating women


Doxycycline Treatment to Prevent Progressive Coronary Artery Dilation in Children With Kawasaki Disease

Summary: Kawasaki disease (KD) affects infants and young children causing inflammation of the skin and blood vessels including the coronary arteries of the heart. Despite the currently available therapy, about one third of children develop enlargement of the coronary arteries that can lead to serious complications such as coronary artery stenosis, heart attack and even death.~Kawasaki disease is the most common heart disease in children in the USA and it is especially common among the children of Hawaii. Every year, 50-90 children are diagnosed with KD in Hawaii and unfortunately there is no medication available to successfully prevent coronary artery damage in a subset of cases.~During the first few weeks of the illness, cells of the immune system attack the coronary arteries and release a special substance (MMP) that is responsible for the coronary artery enlargement. There is a common antibiotic, doxycycline that can specifically block the action of this special substance (MMP). Research done on animals with KD showed that doxycycline was able to block this special substance and prevent enlargement of coronary arteries. Research in adults with enlargement of the main artery in their abdomen also showed that doxycycline may improve the outcome. Based on these studies doxycycline may be a promising therapy for children with KD, who develop enlargement of the coronary arteries.~The investigators' proposed research study will assess the usefulness of doxycycline in preventing the progressive enlargement of coronary arteries in children with KD. The investigators plan to perform a small (pilot) study to evaluate how good is doxycycline in preventing coronary artery enlargement. The investigators will treat 50 children with KD and enlarged coronary arteries for three weeks with doxycycline and assess the change in coronary arteries as well as the blood levels of the special substance (MMP). If doxycycline proves to be beneficial in this small study, the investigators are going to design a large research study involving multiple institutions on Hawaii and the mainland and will recruit more children to be certain about the value of the proposed treatment. The investigators' proposal may change the treatment protocol of KD and could present a possible treatment for children with enlarged coronary arteries preventing potentially devastating consequences.
Inclusion criteria: inclusion criteria:

 Treatment arm: Patients aged 1 month to 21 years with confirmed KD will be included in the study if they meet the following criteria:

 Patients with dilation of the right or left anterior descending coronary artery beyond a z-score of +2.5 during the acute febrile phase of KD.

 Patients with aneurysms of the right or left main coronary arteries during the acute febrile phase of KD.

 Patients with refractory KD after initial treatment with IVIG and dilated coronary arteries on an echocardiogram during the first month of KD.

 Comparison arm: Patients aged 1 month to 18 years with confirmed KD, who do not meet inclusion criteria to be included in the treatment group.

 1.Patients with right or left anterior descending coronary artery measurements below a z-score of +2.5 during the acute febrile phase of KD.

Exclusion criteria: :

 The following patients will be excluded from this study:

 Patients with clinically incomplete KD.

 Patients whose parents refuse to administer doxycycline.

 Patients with acute renal failure.

 Patients with chronic liver and kidney disease.

['Kawasaki Disease', 'Coronary Aneurysm']


Octanol to Treat Essential Tremor

Summary: This study will evaluate the effectiveness of 1-octanol, a substance similar to alcohol but less intoxicating, for treating essential tremor. Essential tremor is an involuntary shaking, usually of the hands, for which there is no satisfactory treatment. It affects about 1.4 percent of the general U.S. population, with the figure climbing to nearly 4 percent among people over 40. Results of two previous NIH studies have shown 1-octanol to be promising as a potential new treatment. This study will test the effectiveness of 1-octanol on essential tremor at doses lower than those given previously.~Patients 21 years old and older with essential tremor may be eligible for this study. Participants are admitted to the NIH Clinical Center for two treatment periods of 1 week each, with a 1-week break at home between treatments. Before beginning treatment, participants undergo a medical history, physical examination, blood and urine tests, and an electrocardiogram (EKG). In addition, tremors are measured using accelerometry, a procedure in which a small device, mounted on a piece of cardboard, is taped to the patient's hand for about 30 minutes.~Patients are randomly assigned to one of two groups. One group takes 2 to 4 capsules of 1-octanol 3 times a day for 1 week, followed by a 1-week washout period (no treatment), and then 2 to 4 capsules of placebo 3 times a day for 1 week. Following the same dosage schedule, the second group takes placebo the first week, followed by the washout period and then 1-octanol treatment. Blood pressure and pulse are measured at 15, 30, and 60 minutes after the first dose of the day and then 3 times a day each day of hospitalization, EKG and blood draws are done every other day during hospitalization, and blood is drawn again 1 week after the end of the study. Patients evaluate their tremor daily according to a tremor scale and are also rated according to an alcohol intoxication scale.
Inclusion criteria: inclusion criteria:

 14 patients with a clinical diagnosis of essential tremor will participate in the study. Selection criterion is essential tremor with a history of ethanol responsiveness. Informed consent will be obtained by any of the co-investigators.

 Patients must be off any medications used to treat essential tremor such as mysoline or propranolol for at least 2 weeks. Patients must withhold ethanol and caffeine 24 hours prior to starting the treatment periods through the end of treatment periods, including alcohol or caffeine containing over the counter medications. Ethanol and caffeine consumption is allowed in the washout period.

Exclusion criteria: :

 Patients with abnormalities on neurologic exam other than tremor.

 Patients with a history of chronic alcohol dependence.

 Patients with chronic medical conditions such as renal failure, hepatic failure and chronic lung disease.

 Patients on other medications that cannot be temporarily discontinued for the length of the study.

 Patients, who, for moral or religious reasons, do not wish to take a potentially intoxicating drug.

 Patients with abnormalities on their baseline screening laboratory tests.

 Women who are pregnant or lactating.

 Patients under the age of 21.

 Asians and Pacific Islanders.


ETREAT Study on Effectiveness of Botulinum Toxin Type A Injections to Treat Post-stroke Upper and/or Lower Limb Spasticity

Summary: The objective of this study is to evaluate the effectiveness of BoNT-A on functional improvement in patients with post-stroke upper and/or lower limb spasticity in the early stage of spasticity development, according to routine clinical practice.
Inclusion criteria: inclusion criteria:

 Men and women ≥ 18-80 years.

 Poststroke limb spasticity.

 Patients who have suffered a stroke in the previous 6 months.

 Treatment goal has been previously agreed with the patient or their legal representative.

 Patients with clinically significant poststroke upper/lower limb spasticity, in whom it has been decided to perform multidisciplinary treatment with BoNT-A + rehabilitation.

 No previous treatment with BoNT-A.

 Patient is able to follow the protocol.

 Written informed consent.

Exclusion criteria: :

 Neuromuscular disease.

 Use of drugs that interfere with neuromuscular transmission.

 Any other condition that could interfere with rehabilitation or evaluation of the results.

 Diagnosis of spasticity not associated with stroke.

 Pregnant or nursing mothers.

 Prior participation in any other study in the 6 months before study entry


Natural History of Peripheral Arterial Disease

Summary: The Veterans Administration Patient Study examined the progression of peripheral arterial disease (PAD) in patients with large vessel PAD or isolated small vessel PAD. The Community Follow-up Study following subjects with and without PAD from a previous cohort to determine subsequent coronary heart disease and cardiovascular disease morbidity and mortality.
Inclusion criteria: No eligibility criteria
Exclusion criteria:

['Atherosclerosis', 'Coronary Disease', 'Arterial Occlusive Diseases', 'Peripheral Vascular Diseases', 'Cardiovascular Diseases']

Atherosclerosis
Coronary Disease
Arterial Occlusive Diseases
Peripheral Vascular Diseases
Cardiovascular Diseases


Immunogenicity of Rabies Vaccine for Pre Exposure Prophylaxis

Summary: The purpose of this study is to compare the effectiveness of a two dose versus a three dose schedule and intramuscular versus intradermal injection for pre-exposure prophylaxis.
Inclusion criteria: inclusion criteria:

 Male and non-pregnant females aged ≥ 18 to ≤ 60 years on the day of inclusion Able to comprehend and give informed consent Able to attend all scheduled visits and to comply with all trial procedures Subject in good health, based on medical history and physical examination

Exclusion criteria: :

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

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

 Previous history of receiving the rabies vaccine.

 Previous history of receiving rabies immune globulin.

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


Effect of Gabapentin on Orthopedic Pain

Summary: This study is being done to determine if a drug called gabapentin helps in the postoperative management of patients undergoing hip and knee operations. The investigators wish to determine the effect of gabapentin on pain and sleep following surgery. If we can lessen a patient's pain and improve sleep, the patient will be better able to participate in their physical therapy. Gabapentin has already been shown to lessen postoperative pain when given before surgery. In healthy patients, it has also been shown to improve certain aspects of sleep. We hope to identify the effect of the drug, when given after surgery, on patients' pain and sleep.
Inclusion criteria: inclusion criteria:

 Undergoing a hip arthroplasty, total knee arthroplasty, hip fracture repair American Society of Anesthesiologist rating I-III as determined by your anesthesiologist

Exclusion criteria: :

 Pregnancy and breast feeding

 An allergy to any of the drugs to be used in the study (midazolam, Celecoxib, gabapentin, hydromorphone, bupivacaine)

 History of a sleep disorder (Obstructive sleep apnea or daytime somnolence)

 History of taking chronic narcotic pain medications or gabapentin

 History of rheumatoid arthritis, a psychiatric disorder, or diabetes with impaired renal function

 History of alcohol or illicit drug abuse.

 History of a kidney or liver problem.

 Inability or unwilling to use patient-controlled analgesia.

 Unable to meet the criteria for removal of the endotracheal tube in the Operating Room

 History of asthma, hives or an allergic type reaction following an aspirin or other NSAIDS drug such as Ibuprofen.

 History of stroke or heart attack or thrombotic event within the past 3 months

 Lactose intolerance

 History of cardiac surgery

['Degenerative Arthritis and Postoperative Pain']


Resilience for Older Workers With OA Through Exercise

Summary: Exercise is effective at reducing pain while improving physical function. However we do not know if exercise can boost resilience in the workplace, to allow people with osteoarthritis to work as long as they desire. Previous research shows that exercise holds the most promise for helping people enjoy their work because it reduces sick time, reduces pain, and improves productivity. However, little work has examined the effect of exercise for people with arthritis in the workplace. The purpose of the study is to investigate whether exercise improves resilience in the workplace, mobility, fitness, strength, and pain in comparison to no exercise in those with knee and/or hip osteoarthritis.
Inclusion criteria: inclusion criteria:

 45 years of age or older

 McMaster employee

 Sedentary job (stand or walk for <1/3 of work day)

 Able to safely climb two flights of stairs

 Hip pain

 Hip pain during internal rotation and hip flexion

 Knee pain

 Less than 30 minutes of morning stiffness in the knee

 Crepitus in the knee with active range of motion

 Bony enlargement around the knee

 Bony tenderness to palpation at the knee

 No warmth around the knee

Exclusion criteria: :

 Any other forms of arthritis

 Osteoporosis-related fracture

 History of patellofemoral symptoms

 Active non-arthritic hip or knee disease

 Hip or knee surgery

 Use of cane or walking aid

 Unstable heart condition

 Neurological conditions

 Hip, knee or ankle injuries in past 3 months

 Physician-advised restriction to physical activity

 Any injuries that would prohibit participation in exercise

 Ipsilateral ankle conditions

 Currently receiving cancer treatment

 Currently pregnant

['Osteoarthritis, Knee', 'Osteoarthritis, Hip']


Effects of Antipsychotic Medications on Energy Intake and Expenditure

Summary: Aim 1: To evaluate the effect of antipsychotic treatment group on Activity Energy Expenditure. The project hypothesizes that subjects treated with olanzapine will demonstrate a greater decrease in AEE over time than subjects treated with ziprasidone, due at least in part to sedating effects of olanzapine.~Aim 2: To evaluate the effect of antipsychotic treatment group on Energy Intake. The project hypothesizes that subjects treated with olanzapine will demonstrate a greater increase in EI over time than subjects treated with ziprasidone, based on higher histamine type 1 (H1) receptor affinity of olanzapine and the relationship between H1 affinity and hunger and/or satiety.
Inclusion criteria: inclusion criteria:

 non-diabetic

 schizophrenic or schizoaffective

 currently prescribed olanzapine or ziprasidone

 18-80 y.o.

Exclusion criteria: :

 <18 or >80 years of age

 diabetic

 not schizophrenic or schizoaffective

 not currently prescribed olanzapine or ziprasidone

['H218O and 2H2O, administered as a mixed cocktail']

H218O and 2H2O
administered as a mixed cocktail

['Schizophrenia', 'Schizoaffective Disorder', 'Weight Gain']

Schizophrenia
Schizoaffective Disorder
Weight Gain


The Optimization of Bioavailability From Iron Supplements: Study 1

Summary: Iron deficiency (ID) with or without anaemia (IDA) is a major public health problem worldwide, especially in women of reproductive age and young children. Iron supplementation is an effective strategy to prevent and treat ID and IDA. There is a lack of data on iron bioavailability from different supplementation regimens and how to optimize bioavailability in a cost-effective and patient-friendly way. The present study will test whether the fractional and total iron absorption from iron supplements (60 mg) administered daily for 14 days differs from that of iron supplements (60 mg) administered every second day for 28 days. The prevailing serum hepcidin concentration (SHep) is the major determinant of iron absorption and erythrocyte iron utilization. Therefore we will monitor SHep during the whole supplementation period. We hypothesize that the fractional and total iron absorption from the daily administration of 60 mg is lower than that from the administration on every second day due to increased SHep levels when supplements are administered daily.~The study will provide important insights about the optimization of iron bioavailability from different supplementation regimens including the performance of SHep, a key regulator of human iron metabolism.
Inclusion criteria: inclusion criteria:

 Female, 18 to 45 years old,

 Serum ferritin levels </=25 µg/L,

 Normal body Mass Index (18.5-26.5 kg/m2),

 Body weight <80 kg,

 Signed informed consent

Exclusion criteria: :

 Anaemia (Hb < 8.0 g/dL),

 Elevated c-reactive protein or alpha1-glycoprotein concentrations >5.0 mg/L, >1.0 g/L, respectively,

 Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement),

 Continuous/long-term use of medication during the whole studies (except for contraceptives),

 Consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration,

 Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months,

 Earlier participation in a study using stable iron isotopes,

 Known hypersensitivity or allergy to iron supplements,

 Women who are pregnant or breast feeding,

 Intention to become pregnant during the course of the studies,

 Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.

 Known or suspected non-compliance, drug or alcohol abuse,

 Inability to follow the procedures of the studies, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,

 Participation in another study with investigational drug within the 30 days preceding and during the present studies,

 Enrolment of the investigator, his/her family members, employees and other dependent persons

['Daily administration of 60 mg iron in form of ferrous sulphate capsules for 14 consecutive days', 'Administrations of 60 mg iron in form of ferrous sulphate capsules on every second day for 28 days']

['Iron Deficiency', 'Anemia', 'Iron Deficiency Anemia']

Iron Deficiency
Anemia
Iron Deficiency Anemia


Bioavailability of 3 Sildenafil Oral Disintegrating Tablet Formulations Compared to the Standard Oral Tablet

Summary: The bioavailability of the oral disintegrating tablet formulations given without water will be similar to an equivalent dose of the standard oral tablet given with water.
Inclusion criteria: inclusion criteria:

 Healthy subjects

 Weight: BMI from 17.5 to 30.5

Exclusion criteria: :

 Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

 A positive urine drug screen.

['Viagra 50 mg tablet', 'Formulation B ODT tablet 50 mg', 'Formulation C ODT tablet 50 mg', 'Formulation D ODT tablet 50 mg']

Viagra 50 mg tablet
Formulation B ODT tablet 50 mg
Formulation C ODT tablet 50 mg
Formulation D ODT tablet 50 mg


A Clinical Study for Magnetic Stimulation of the Posterior Tibial Nerve in Overactive Bladder

Summary: To evaluate the safety and feasibility of non-invasive magnetic stimulation of the posterior tibial nerve using the EMKinetics LoFIT Pulse System for treating patients with documented overactive bladder.
Inclusion criteria: inclusion criteria:

 Women >18 years of age

 A score of > 4 on the OAB-q short form for urgency (question 1)

 Average urinary frequency > 10 times in one 24 hour day based on a 3-day voiding diary

 Self-reported bladder symptoms present > 3 months

 Self-reported failed conservative care (e.g., dietary restriction, fluid restriction, bladder training, behavioral modification, pelvic muscle training, biofeedback, etc.) or use of antimuscarinics.

 Off all anti-muscarinics for at least 2 weeks prior to enrollment

 Capable of giving informed consent

 Ambulatory and able to use a toilet independently, without difficulty

 Capable and willing to follow all study-related procedures

Exclusion criteria: :

 The patient is pregnant or intends to become pregnant during the course of the study. (Patients becoming pregnant during the course of the study will immediately be terminated from the study.)

 The patient has an active urinary tract infection.

 Neurogenic bladder

 Botox use in bladder or pelvic floor muscles in the past year

 Pacemakers or implantable defibrillators

 Primary complaint of stress urinary incontinence

 Current vaginal infection

 Current use of InterStim

 Current use of Bion

 Current use of TENS in the pelvic region, back or leg

 Previously been treated with PTNS

 Use of investigational drug/device therapy within the past 4 weeks

 Participating or have participated within the past 4 weeks in any clinical investigation involving or impacting gynecologic, urinary or renal function

 Deemed unsuitable for enrollment in study by the investigators based on subjects' history or physical examination

 The patient has metal implant from surgery or a metallic foreign body in either leg below (distal to) the knee (or permanent metallic tattoo <30cm from left ankle).

 The patient has chronic constipation (less than two (2) bowel movements per week)

 The patient has history of gastric or urinary retention

 The patient has uncontrolled diabetes

 Subjects with nerve damage, injury or surgery that would impact either tibial nerve or pelvic floor function

 The patient is unable or unwilling to sign informed consent

 The patient is currently on pharmacologic treatment that could affect bladder function

 Known Cystocele >/= to Grade 3 that has not been reduced by treatment (surgery or pessary)

['EMKinetics non-invasive Magnetic neurostimulator']


Purified Vero Rabies Vaccine-Serum Free Compared to Human Diploid Cell Vaccine in a Pre-exposure Prophylaxis Regimen

Summary: The aim of the study is to document immunogenicity and safety of VRVg in a pre-exposure regimen in healthy children and adolescents aged 2 to 17 years.~Primary Objectives:~To demonstrate that VRVg is non-inferior to Imovax® Rabies in terms of proportion of subjects achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 international units (IU)/mL at D42, i.e. 14 days after the last vaccination.~To describe if at least 99% of subjects achieve an RVNA titer ≥ 0.5 IU/mL at D42 with a lower bound of the 95% confidence interval (CI) of at least 97%, in the VRVg group.~Secondary Objectives:~To assess the clinical safety of each vaccine after each vaccine injection when administered in a pre-exposure schedule.~To describe the immune response induced by each vaccine 14 days after the last vaccination, i.e. at D42, and 6 months after the first vaccination~To describe the geometric mean titer ratio between the two vaccine groups at D42, i.e. 14 days after the last vaccination.
Inclusion criteria: inclusion criteria:

 Aged 2 to 17 years on the day of inclusion

 Informed consent form has been signed and dated by the parent(s) (and subject, if applicable by local regulations), or another legally acceptable representative and by an independent witness, as applicable, and the assent form has been signed and dated by the subject (if applicable by the local Ethics Committee or country regulations)

 Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures.

Exclusion criteria: :

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

 Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure

 Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks following any trial vaccination

 Any previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial vaccine or another vaccine

 Bite by a potentially rabid animal in the previous 6 months without post-exposure prophylaxis

 Receipt of immune globulins, blood or blood-derived products in the past 3 months

 Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

 Self-reported seropositivity for Human Immunodeficiency Virus (HIV)

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

 Self-reported thrombocytopenia, contraindicating intramuscular vaccination

 Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination

 Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily

 Current alcohol abuse or drug addiction

 Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion

 Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided

 Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study

 History of Guillain-Barré syndrome.

['Purified Vero Rabies Vaccine Serum Free (VRVg)', 'Imovax® Rabies: Human Diploid Cell Vaccine (HDCV),']


Safety and Efficacy Study of Vilazodone and Discovering Genetic Markers Associated With Response in Patients With Major Depressive Disorder

Summary: The purpose is to evaluate the safety and usefulness of the investigational drug, vilazodone in depression.
Inclusion criteria: inclusion criteria:

 Male or female patients 18-65 years of age, inclusive.
Exclusion criteria:


DNA Methylation and Autoimmune Thyroid Diseases

Summary: Hashimoto Thyroiditis (HT) and Graves Disease (GD) are known to be caused by abnormal immune response against self cells and tissues. Epigenetics is a novel field of biology studying the mechanisms by which the environment interacts with the genotype to produce a variety of phenotypes through modifications to chromatin that do not directly alter the DNA sequence. A very limited number of epigenetic studies have been published in patients with HT and GD so far. Therefore, the purpose of this study is to analyze DNA methylation status in White Blood Cells (WBCs) within the promoter regions of genomic sites that have been previously identified as susceptibility loci or sites for autoimmune thyroid disease, such as the CD40L, FOXP3, CTLA4, PTPN22, IL2RA, FCRL3 and HLADRB1 genes.
Inclusion criteria: inclusion criteria:

 For HT:

 A positive titers of antithyroid peroxidase (anti-TPO) or antithyroglobulin (anti-Tg) antibodies and at least one of:

 Abnormal thyroid function that requires substitution treatment with L-thyroxine (TSH > 5 μIU/ml and decreased or normal levels of fT4 or fT3)

 Increased volume of thyroid gland (goiter)

 Morphological changes on ultrasound of the thyroid gland

 For GD:

 A positive titers of thyroid stimulating antibodies (anti-TSI) and

 Decreased TSH levels and increased levels of fT4 or fT3

 For Controls:

 Otherwise healthy children and adolescents, age- and gender-matched with patients

 Absence of previously known chronic disease of autoimmune aetiology or atopy (including those with a history of chronic treatment with antihistamines, anti-inflammatory, corticosteroids or anti-epileptic drugs)

 Absence of a family history of autoimmune disease in first-degree relatives

Exclusion criteria: :

 Not Caucasian origin or affinity among participants

 Age of diagnosis above 18 years

 Disease duration below 3 months

['Hashimoto Thyroiditis', 'Graves Disease']


A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis

Summary: This study will compare the Non Steroidal Anti-Inflammatory Drugs (NSAIDs) sparing effect of etanercept with that of placebo in adult subjects with axial Spondyloarthritis.
Inclusion criteria: inclusion criteria:

 Male and female subjects aged 18 years and over at the time of consent to the study.

 Diagnosis of SpA, as defined by the ASAS criteria for axial SpA

 Axial involvement refractory to previous or current intake of NSAIDs, defined as at least 2 NSAIDs at maximum tolerated dose determined from past medical history taken for a duration of > 1 month (for both NSAIDs combined) before the Screening visit.

 Active axial involvement defined by mini BASDAI

Exclusion criteria: :

 Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.

 Subjects who have received any previous treatment with etanercept or other TNFα inhibitors or biologic agents.

 Subjects with a known or expected allergy, contraindication, or hypersensitivity to etanercept or its excipients.


Effect of Saline Lubrication on Post-intubation Complications

Summary: The purpose of this study is to evaluate the influence of none-lubricated dry tube on the incidence of Postoperative Sore Throat (POST) after general anesthesia with endotracheal intubation.
Inclusion criteria: inclusion criteria:

 patients aged between 20-80 years who were scheduled for surgery under general anesthesia requiring orotracheal intubation

Exclusion criteria: :

 history of gastroesophageal reflux disease (GERD)

 congenital or acquired abnormalities of the upper airway such as tumor, polyp, trauma, abscess, inflammation, infection, or foreign bodies

 previous airway surgery; increased risk of aspiration

 coagulation disorders

 previous history of difficult intubation or conditions with expected difficult airway including Mallampati classification ≥ 3 or thyromental distance < 6.5 cm

 Using the other intubation devices beyond the direct laryngoscopy such as lighted stylet or fiberoptic bronchoscopy

 symptoms of sore throat or upper respiratory tract infection

 expected to place nasogastric tube during perioperative period

 requiring nasotracheal intubation


Vitamin B6, B12, Folic Acid and Exercise in Parkinson's Disease

Summary: This experiment seeks to determine whether individuals with PD will benefit from vitamin B6 (pyridoxine hydrochloride), B12 (cyanocobalamin), and Folic Acid supplementation, whether they will benefit from a 6-week circuit training program, or whether they will benefit from a combination of the two interventions. The outcome variables will include: plasma homocysteine, GSH:GSSG ratio, cognitive function, balance, strength, functional activities, kinematic gait analysis, and a quality of life questionnaire.
Inclusion criteria: inclusion criteria:

 Medical clearance to perform an exercise tolerance test and training program.

 A diagnosis of PD at stage 2 on the Hoehn and Yahr scale.

Exclusion criteria: :

 A neurological condition other than PD/

 Anyone who is currently taking any vitamin supplementation.

 Smokers.

 Anyone currently engaged in weight training.

['PD vitamin supplementation', 'PD exercise intervention', 'PD vitamin + exercise']

PD vitamin supplementation
PD exercise intervention
PD vitamin + exercise


Evaluation of ELISA Assay on Human Papilloma Viruses (HPV) Infection Population

Summary: Cervical cancer the most frequent neoplasm and the fifth mortality rate of malignancies of the women in the world. It results in about 1,000 women in Taiwan and about 200,000 women worldwide dying of cervical cancer each year. Human papilloma viruses (HPV) have been consistently implicated in causing cervical cancer especially those high-risk types (HPV 16,18,31,45) have been strongly associated with cervical cancer. Around 50-80 % of women are infected by HPV within their whole lives. However, only 1% of HPV-infected women have cervical cancer eventually. Seventy and 91% of HPV infection could be cleaned up by host immune responses within 1 and 2 years later. It shows that host immunity plays an important role in the progression, persistence, or regression of HPV infection.~There are two main defense lines in the host immunity including innate immunity and adoptive immunity. Adoptive immunity plays more important roles in the defense of HPV infections than innate immunity. The adoptive immunity could be further divided into humoral immunity and cell-mediated immunity. Humoral immunity regulated by Th2 helper T lymphocytes to generate memory B cells to produce antibody which provide the protective function to HPV infection. Cell-mediated immunity regulated by Th1 helper T lymphocytes to induce antigen-specific cytotoxic T cells which could kill the HPV-infected cells. Although there are many researches focused on the immunity to HPV infection, there is no conclusion about the relationship between humoral and cell-mediated immunities on HPV infection and roles of humoral and cell-mediated immunities in the prognosis of HPV-infected population and cervical cancer patients.~Our research team has focused on the establishment of platforms on cell-mediated immunity to HPV infection and on the correlation of cell-mediated immunity and prognosis of HPV-infected population and cervical cancer patients for years. In order to survey the host immunity to HPV infection more comprehensively, we propose this proposal. First, we would like to set up the platforms to elucidate the humoral immunity to HPV infection in normal population and patients with CIN lesion or cervical cancer. Second, we would to survey the correlation betweem humoral immunity and status and clinico-pathologic items of HPV-infected populations. Our research results will have a more comprehensive overview in the host immunity to HPV infection and its related diseases. It could provide more information in the prevention and treatment of HPV infection in the future.
Inclusion criteria: inclusion criteria:

 Healthy volunteers

 People infected with HPV type 16 but without CIN lesions

 Patients with CIN lesions

 Patients with cervical cancer from National Taiwan University Hospital

 Informed consent is obtained, and the protocols are reviewed and approved by the appropriate Investigative Review Boards
Exclusion criteria:

['Patient With Invasive Cervical Carcinoma', 'Patient With CIN Lesion', 'Patient With HPV Infected Patients Without Histopathologic Lesion', 'Normal Populations.']


A Study to Assess Safety, Immunogenicity and Parasite Growth Inhibition of an Asexual Blood Stage Vaccine for P. Falciparum Malaria

Summary: Malaria is a parasite, infection with which kills over 2 million people each year. It is a major problem for those who live in endemic areas and for travellers. There is a great need for a safe effective malaria vaccine. The purpose of this study is to examine a new vaccine designed to provide immunity during the blood stage of the malaria parasite's lifecycle.~The vaccine consists of AMA1-C1 which is a mixture of two recombinant synthetic AMA1 proteins from two Plasmodium falciparum strains, Alhydrogel® which is an aluminium-based adjuvant and CPG 7909 - an oligodeoxynucleotide, which enhances immune response.~This study will enable the investigators to assess:~The ability of of a growth inhibition assay to predict the effectiveness of a malaria vaccine.~The safety of the vaccine in healthy volunteers~The response of the human immune system to the vaccine
Inclusion criteria: inclusion criteria:

 Subject is willing and able to give informed consent for participation in the study

 Healthy, non pregnant adult aged 18 - 50 years

 Resident in or near Oxford for the duration of the challenge study

 Seropositive for CMV and EBV

 Female subjects of child bearing potential must be willing to ensure that they practice effective contraception during the study

 Males must be willing to use barrier contraception from day of first vaccination onwards until 3 months after the second vaccination

 Able (in the Investigator's opinion) and willing to comply with all study requirements

 Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study

 Agreement to permanently refrain from blood donation.

Exclusion criteria: :

 Any deviation from the normal range in biochemistry or haematology blood tests or in urine analysis as defined in Appendix B

 Female patient/subject who is pregnant, lactating or planning pregnancy during the course of the study

 Healthy volunteers who have participated in another research study involving an investigational product in the past 12 weeks

 Subjects who have previously received an investigational malaria vaccine

 History of malaria chemoprophylaxis with chloroquine within 5 months prior to the planned challenge, with Lariam within 6 weeks prior to the challenge, and Riamet® within 2 weeks prior to the challenge

 Travel to a malaria endemic area within the previous 6 months

 Planned travel to malarious areas during the study period

 Any history of malaria

 Contraindication to both anti-malarial drugs (Riamet® and chloroquine)

 concomitant use of other drugs known to cause QT-interval prolongation, ( e.g. macrolides, quinolones, amiodarone etc)

 An estimated ten year risk of fatal cardiovascular disease of ≥5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system (Conroy 2003)

 Family history of sudden cardiac death

 History of cardiac arrhythmia or prolonged QT syndrome

 Any history of severe allergic reaction or anaphylaxis

 History of a known allergy to nickel

 Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months

 History or evidence of pre-existing autoimmune or antibody mediated disease or laboratory evidence of possible autoimmune disease (defined as anti-dsDNA ≥ 25 IU/mL)

 Seropositive for hepatitis B surface antigen (HBsAg) or antibodies to hepatitis C virus

 Any on-going chronic illness requiring hospital specialist supervision

 Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate

 History of or current intravenous drug abuse

 Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week

 Any other significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or may influence the result of the study, or the subject's ability to participate in the study.

 Investigator assessment of lack of willingness to participate and comply with all requirements of the protocol


Acromio-clavicular Dislocation Type III - Conservative Treatment Versus Surgical Hook Plate Treatment

Summary: Acromio-clavicular (AC) joint dislocation corresponds to 8.6% of all joint dislocations and represents a major injury to the shoulder girdle. The nature of the treatment is decided according to the severity of the lesion.~The purpose of this study is to determine whether the surgical treatment is required or not for type III AC joint dislocations.
Inclusion criteria: inclusion criteria:

 men or women ≥ 18 years-old;

 AC joint dislocation type III with Zanca X-ray view demonstrating CC distance of 200%;

 trauma-surgery delay of less than 14 days;

 consent form signed.

Exclusion criteria: :

 AC joint dislocation type I, II, IV, V or VI;

 associated neuro-vascular damage;

 men or women > 60 years-old;

 open dislocation;

 local skin damage;

 dislocation in a polytrauma patient;

 floating shoulder;

 fracture of the ipsilateral or controlateral arm or shoulder girdle;

 fracture of the coracoid process of the scapula;

 history of previous surgery to the shoulder;

 medical condition preventing surgery;

 men or women unfit to consent;

 any other condition that make the examinator thinks that the follow up would be problematic.

['Conservative treatment - brace', 'Hook plate by Synthes']

Conservative treatment - brace
Hook plate by Synthes

['Acromio-clavicular Joint Dislocation (Type III)']