The Value of Pancreatic Stone Protein in Predicting Acute Appendicitis

Summary: PSP (Pancreatic Stone Protein) is a compound naturally produced mainly in the pancreas and the gut. There is evidence from experimental and clinical trials that the levels of PSP in the blood rise in the presence of inflammation or infection. What is not yet well known about PSP is whether it is superior to other established blood tests (e.g. WBC or CRP) in predicting appendicitis in patients that present at the emergency room with abdominal pain and a clinical suspicion of appendicitis.
Inclusion criteria: inclusion criteria:

 Age >18 years of age (subject to the current ethics approval protocol, may change)

 Clinical suspicion of appendicitis as the primary or differential diagnoses

 Patients able to provide informed consent

Exclusion criteria: :

 Age <18 years of age (subject to the current ethics approval protocol, may change)

 Abdominal discomfort without tenderness or rebound or clinical suspicion of appendicitis

 Pregnancy

 Patients with impaired consciousness

 Patients not able to provide informed consent

 Patients that will receive an appendicectomy as part of another elective procedure

['Appendicitis', 'Abdominal Pain', 'Abdominal Sepsis']

Appendicitis
Abdominal Pain
Abdominal Sepsis


EXecutive Registry: Evaluating XIENCE V® in a Multi Vessel Disease

Summary: The purpose of this two part study is the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of the specific setting of patients with Multi-Vessel Coronary Artery Disease (MVD).
Inclusion criteria: inclusion criteria:

 Patient must be at least 18 years of age

 Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XIENCE V® EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site

 Patient has been diagnosed a MVD, as documented by coronary angiography, i.e. presenting a severe stenosis (>50%) amenable to PCI in at least 2 major epicardial vessels or their principal bifurcation branches (diagonal or obtuse marginal)

 Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram -ECG- consistent with ischemia)

 Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery

 Patient must agree to undergo all protocol-required follow-up examinations.

 Angiographic inclusion criteria

 Patients may receive up to 4 planned XIENCE V® EECSS stents, depending on the number of vessels treated and their respective lesion length. When multiple lesions are present in one or more main coronary branches, complete revascularization should be attempted with the implantation of a maximum of 4 planned stents

 Target lesions must be de novo lesions (no prior stent implant, no prior brachytherapy)

 Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate

 Target lesion < or = 28 mm in length by visual estimation

 Target lesions must be in a major artery or its principal branches (diagonal or obtuse marginal) with a visually estimated stenosis of > or = 50%

 Two lesions in a single main coronary artery or its branches do not constitute a MVD situation, therefore this type of patient must not be enrolled

Exclusion criteria: :

 Patient has had a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure (non-procedural/spontaneous MI, CK-MB > or = to 2 times upper limit of normal) and CK and CK-MB have not returned within normal limits at the time of procedure

 Patient has current unstable arrhythmias

 Patient has a known left ventricular ejection fraction (LVEF) <30%

 Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant

 Patient is receiving or scheduled to receive chemotherapy or radiation therapy within 30 days prior to or after the procedure.

 Patient is receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)

 Patient is receiving chronic anticoagulation therapy (e.g. coumadin)

 Patient has a known hypersensitivity or contraindication to aspirin, paclitaxel, either heparin or bivalirudin, clopidogrel or ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated

 Elective surgery is planned within the first 9 months (+/- 14 days) after the procedure that will require discontinuing either aspirin or clopidogrel

 Patient has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3, a WBC of <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)

 Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dl, patient on dialysis)

 Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions

 Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months

 Patient has had a significant GI or urinary bleed within the past six months

 Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e. less than one year)

 Patient is already participating in another investigational use device or drug study or has completed the follow-up phase of another study within the last 30 days.

 Angiographic

['Coronary artery placement of a drug-eluting stent']

['Coronary Disease', 'Coronary Artery Disease', 'Coronary Artery Stenosis', 'Coronary Artery Restenosis']

Coronary Disease
Coronary Artery Disease
Coronary Artery Stenosis
Coronary Artery Restenosis


Ultrasonic Wound Debridement vs. Standard Sharp Debridement

Summary: A single center, randomized, parallel, clinical outcome trial to compare the rate of healing in chronic wounds debrided with either high energy ultrasonic debridement (with cavitation) or standard of care sharp debridement.
Inclusion criteria: inclusion criteria:

 Chronic wound needing debridement >3 cm2

 Ulcer history >4mo

 Adequate arterial blood flow (ABI>0.7)

 Venous, Inflammatory, Pressure, Diabetic

Exclusion criteria: :

 Bleeding disorder

 ABI<0.7

 Uncontrolled diabetes

 Taking systemic corticosteroids

 Chemotherapy

 Participating in another study

 Treatment with Apligraft, Dermagraft, or Regranex within 90 days

['Contact ultrasonic debridement device']


Clinical Relevance of Microbleeds In Stroke

Summary: Study I: CROMIS-2 (AF) Prospective cohort study of patients anticoagulated after cardioembolic stroke An observational inception cohort study (n=1425) of patients throughout the United Kingdom (UK) - (79 hospitals) started on best practice oral anticoagulant (without prior use) for presumed cardioembolic ischaemic stroke due to non-valvular AF with follow up for the occurrence of intracerebral haemorrhage (ICH) and ischaemic stroke for an average of two years. The main baseline exposures (risk factors of interest) are the presence of cerebral microbleeds (CMBs) on magnetic resonance imaging (MRI), and genetic polymorphisms in candidate genes with potential functional relevance to ICH risk.~Study II: CROMIS-2 (ICH) Observational and genetics study of intracerebral haemorrhage The investigators will also recruit 600 patients admitted to participating centres with ICH (with a target of at least 300 anticoagulant-related ICH cases) and collect DNA to increase the power of the genetic studies. The investigators will collect clinical and imaging data from these ICH cases to investigate risk factors associated with anticoagulant-related ICH compared to non anticoagulant-related ICH.
Inclusion criteria: Study I: CROMIS-2 (AF)

 inclusion criteria:

 Adult (≥18y; no upper limit) patients with a clinical diagnosis of non-valvular AF (verified by ECG) with intention to treat with best practice oral anticoagulants (e.g. warfarin)

 Previous ischaemic stroke or TIA diagnosed by treating clinician

 All patients must be able to have GRE MRI before (or within 1 week) of starting best practice oral anticoagulant

Exclusion criteria: :

 Any MRI contraindications

 Previous use of oral anticoagulation

 Definite contra-indication to oral anticoagulation

 Serious head injury (resulting to loss of consciousness)

 Study II: CROMIS-2 (ICH)

 inclusion criteria:

 • Adult (>18y) patients treated at participating centres with confirmed ICH (confirmed on CT or MRI scans) with or without a history of anticoagulant use at the time of the ICH

['Stroke', 'Atrial Fibrillation (AF)', 'Intracerebral Haemorrhage (ICH)']

Stroke
Atrial Fibrillation (AF)
Intracerebral Haemorrhage (ICH)


Seasonal Influenza Vaccine, Quadrivalent Versus Trivalent in Patients With Advanced Chronic Obstructive Pulmonary Disease

Summary: To evaluate the magnitude of the humoral immune responses to quadrivalent vs trivalent influenza vaccines in adults between the age of 50 and 64 years with a prior diagnosis of GOLD Stage C and D COPD vs. those patients without COPD.
Inclusion criteria: inclusion criteria:

 inclusion criteria for patients with COPD will be:

 Signed informed consent prior to initiation of study-mandated vaccination.

 Patients with spirometric data in the preceding 18 months confirming the diagnosis of COPD.

 Patients meeting GOLD Classification of Stage C or Stage D COPD.

 Patients 50 years old - 64 years old.

 inclusion criteria for Healthy participants will be:

 Signed informed consent prior to initiation of study-mandated vaccination.

 No active symptoms of lung disease.

 FEV1/FVC in the normal range > 70% age predicted value.

 No history of tobacco use/abuse.

 No prior history of alpha-1 antitrypsin deficiency.

 Patients 50 years old - 64 years old.

Exclusion criteria: :

 Severe allergy to eggs.

 Severe reaction to past doses of influenza vaccine.

 Guillian-Barre syndrome.

 Currently recieving dialysis.

 Current, active, treatment for cancer.

 History of transplant (allograft).

 Dementia or Alzheimer's disease diagnosis.

 Prior diagnosis of HIV or AIDS.

 Moderate to severe pulmonary hypertension.

 Serum AST/ALT > 3x the upper limit of normal.

 Patients with exacerbations or respiratory infection during the 4 weeks preceding the onset of the study.

 Active pregnancy.

 Systemic immunomodulating medications.

['Chronic Obstructive Pulmonary Disease']


A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)

Summary: This study will determine the rapidity of suppression of the bone resorption marker sCTX in post-menopausal women with osteoporosis.Other bone turnover markers will also be evaluated. Patients will be randomised to either monthly Boniva 150mg or placebo, in combination with vitamin D and calcium supplementation. The anticipated time on study treatment is approximately 7 months, and the target sample size is <100 individuals.
Inclusion criteria: inclusion criteria:

 women who have been newly diagnosed with post-menopausal osteoporosis, requiring treatment;

 naive to bisphosphonate treatment,or had bisphosphonate treatment for a maximum of 3 months, at least 5 years before screening.

Exclusion criteria: :

 patients on hormone replacement therapy (HRT) within the last 3 months;

 patients on other osteoporosis medication within the last 3 months;

 sCTX below lower limit, or above 3 times the upper limit, of normal premenopausal level;

 hypersensitivity to any component of ibandronate;

 contraindication for calcium or vitamin D therapy;

 history of major gastrointestinal upset;

 malignant disease diagnosed within the previous 10 years (except resected basal cell cancer).

['Placebo', 'Vitamin D and calcium supplementation', 'ibandronate [Bonviva/Boniva]']

Placebo
Vitamin D and calcium supplementation
ibandronate [Bonviva/Boniva]


Reliability of Subjective Assessment of Fever by Parents and Health Care Providers in Children and Adolescents

Summary: Background: Fever is a widespread symptom in many diseases. Therefore, its value and diagnostic importance are well known. Fever in children is one of the common reasons for a visit to the pediatrician. Also, taking temperature is a very simple action and accessible to the general public.~Temperature is measured in various parts of the body by using medical equipment. The type of method and thermometer varies according to the patient's age but often temperature is estimated by touch. Temperature measurement serves as a means for monitoring the patient's condition. For that reason, supervision of the body temperature is an important factor in the process of taking medical decisions.~Study rationale: the parent is often asked if the child's temperature has been taken. The most frequent answer is: I didn't measure, but I felt that he has a temperature. The few studies carried out on this subject showed that many parents used touch to evaluate the child's body temperature, especially in infants.~Some studies checked the reliability of parents to estimate the child's body temperature by touch only. To the best of our knowledge, the reliability of medical staff (nurses) to estimate the child's body temperature by touch has never been studied.~The aim of the current study is to investigate whether parents and nurses correctly estimate the child's body temperature by touch, as compared to thermometer measurement during the pediatric unit's routine work.
Inclusion criteria: inclusion criteria:

 The estimates and the measurements will be carried out on children who are referred to an emergency unit and who are hospitalized in the pediatric department-- both boys and girls of all ages. A patient might be measured several times.

Exclusion criteria: :

 None


Osteopathy and Latent Hypothyroidism

Summary: This study evaluates the effectiveness of stimulating the neurological segments c8-th5 in patients with latent hypothyroidism.~One half of the participants will receive an osteopathic manuel treatment in order to stimulate the relevant segments, the other half will receive no treatment.
Inclusion criteria: inclusion criteria:

 latent hypothyroidism

Exclusion criteria: :

 Factors that Alter Thyroxine and Triiodothyronine Binding in Serum

 Increased thyroxin-binding globulin

 Decreased thyroxin-binding globulin

 Binding inhibitors

 Inherited Salicylates

 Pregnancy

 Androgens

 Furosemide

 Neonatal state

 Anabolic steroids

 Free fatty acids

 Estrogens

 Glucocorticoids

 Phenytoin

 Hepatitis

 Severe illness

 Carbamazepine

 Porphyria

 Hepatic failure

 nonsteroidal antiinflammatory drug (variable, transient)

 Heroin

 Nephrosis

 Heparin

 Methadone

 Nicotinic acid

 Mitotane L-Asparaginase

 5-Fluorouracil

 SERMS (e.g., tamoxifen, raloxifene)

 Perphenazine

 spinal pathologies


Detection of Ischemia in Asymptomatic Diabetics

Summary: Asymptomatic subjects with Type 2 Diabetes Mellitus were randomized to either screening with Tc-99m sestamibi adenosine SPECT imaging or no screening. All patients will be followed for 5 years for the occurrence of cardiac death or non-fatal myocardial infarction.~The aims are:~To prospectively assess the prevalence of silent myocardial ischemia in asymptomatic subjects with Type 2 Diabetes Mellitus.~To identify on the basis of clinical and/or biochemical variables in a high-risk cohort in which screening for coronary artery disease is appropriate.~To assess progression of (silent) myocardial ischemia after 3 years.~To assess the occurence of cardiac death or nonfatal myocardial infarction during 5 years follow-up in screened and not screened subjects.
Inclusion criteria: inclusion criteria:

 Age 50-75 years

 Type 2 diabetes mellitus

Exclusion criteria: :

 Angina or anginal equivalent

 Abnormal rest ECG (Q or ST depression)

 Known CAD

 Stress testing within the last 3 years


the Efficacy and Safety of Vitamin C for Iron Supplementation in Adult IDA Patients

Summary: IDA patients ofen receive ferrous succinate treatment to speed up the recovery of anemia, the doctor will prescribe ferrous succinate with or without vitamin C according to their own preferences. In theory, only the divalent iron can be absorbed in duodenum and upper jejunum, vitamin C can oxidize ferric iron into divalent iron and maintains a certain degree of acidity in the intestine, and then promotes the absorption of iron. In current clinical practice, it's lack of randomized controlled trial(RCT) about the efficacy and safety of vitamin C for iron supplementation in patients with IDA. In this study, the efficacy and safety of vitamin C for iron supplementation in adult IDA patients are explored by RCT. The dosage regimens of ferrous succinate with or without vitamin C are randomly assigned to patients who meet the inclusion criteria, and these patients are followed up every two weeks. On the one hand, whether the addition of vitamin C can accelerate the recovery of anemia is evaluated, on the other hand, whether the addition of vitamin C can increase the incidence of gastrointestinal tract discomfort is aslo appraised , the discomfort include vomiting, nausea, abdominal pain, diarrhea and constipation. We hypothesis that vitamin C can increase the absorption of iron and accelerate the recovery of anemia, it also increases incidence of gastrointestinal adverse events because of increased iron absorption at the same time.
Inclusion criteria: inclusion criteria:

 Hemoglobin (Hb) < 120 g/L in men and Hb < 110 g/L in women; Mean Corpuscular Volume(MCV) < 80 fl, Mean Corpuscular Hemoglobin(MCH) < 27 pg, and Mean Corpuscular Hemoglobin Concentration(MCHC) < 0.32; the blood biochemical examination: serum ferritin < 12 g/L, serum iron < 8.95 mol/L, transferrin saturation <15%, and total iron binding capacity>64.44 mol/L; with a history of Menorrhagia, monophagia or eating disorders; Willing to sign a Informed consent form.

Exclusion criteria: :

 Pregnant women; drug allergy; the patients with serious gastrorrhagia, other peptic ulcers, active bleeding, hepatic insufficiency, heart disease or renal insufficiency; those patients can't tolerate the medicine orally, or participate in other clinical study, or refuse to sign a Informed consent Form.

['ferrous succinate and vitamin C', 'ferrous succinate', 'ferrous succinate']

ferrous succinate and vitamin C
ferrous succinate
ferrous succinate


Chest Pain Observation Unit Risk Reduction Trial

Summary: The purpose of this study is to determine whether a brief counseling intervention initiated in the chest pain observation unit has a significant impact upon the health attitudes (readiness to change) and cardiovascular risk-related behaviors (diet, exercise, and smoking) of emergency department patients.
Inclusion criteria: inclusion criteria:

 At least one modifiable cardiovascular risk factor (smoking, hyperlipidemia, hypertension, diabetes mellitus, obesity)

Exclusion criteria: :

 Patients who rule-in for myocardial ischemia at initial testing

 Terminally ill (expected to survive less than 3 months)

 Unavailable for 6-month follow-up

 Cannot be contacted by telephone

 Institutionalized persons (prisoners, nursing home residents)

 Unable to provide informed consent (impaired mental status, unable to speak English)

['Full counseling', 'Minimal counseling']


The Study of the Safety and Efficacy of Ampligen in Chronic Fatigue Syndrome

Summary: multi-center, double-blind, randomized, placebo-controlled study of the safety and efficacy.
Inclusion criteria: inclusion criteria:

 A diagnosis of CFS, as defined by the Center for Disease Control (1988 CDC case definition) > 12 months (Appendix D).

 Age Range: > 18 years old, < 60 years old.

 Males or non-pregnant, non-lactating females: Females must be of non-child bearing potential (either post-menopausal for two (2) years or surgically sterile including tubal ligation) or using an effective means of contraception (birth control pills, intrauterine device, diaphragm). Females who are less than two (2) years post-menopausal, those with tubal ligations and those using contraception must have a negative serum pregnancy test within the two (2) weeks prior to the first study medication infusion. Females of child bearing potential agree to use an effective means of contraception from four (4) weeks prior to the baseline pregnancy test until four (4) weeks after the last study medication infusion.

 A reduced quality of life as determined by a documented KPS of 40 to 60 on three (3) occasions, each at least 14 days apart, during the twelve (12) weeks immediately preceding the start of study drug infusions. The KPS must be rounded in increments of ten (10).

 Ability to walk (minimum of 20 seconds) on the moving treadmill (grade = 0%; belt speed = 1 mph) on a minimum of two (2) occasions during the twelve (12) weeks immediately preceding study entry.

 Laboratory documentation (baseline or historical following onset of CFS/ME) of a negative ANA or a negative anti-ds (double-stranded) DNA, a negative Rheumatoid Factor, and an erythrocyte sedimentation rate (ESR).

 Laboratory documentation that the patient is euthyroid (patients on thyroid replacement therapy must be on a stable dose during the eight (8) week washout period) based on a thyroid profile (T4, T3, TSH, T3 uptake and Free T4 index) performed during baseline.

 Ability to provide written informed consent indicating awareness of the investigational nature of this study.

Exclusion criteria: :

 -

['Chronic Fatigue Syndrome', 'Myalgic Encephalomyelitis']

Chronic Fatigue Syndrome
Myalgic Encephalomyelitis


Safety of Haemophilus Influenza Type b Vaccine When Administered to Korean Children

Summary: This is a multicenter, post marketing surveillance study which aims to evaluate the safety profile of haemophilus influenza type b vaccine when administered to Korean children according to the product insert.
Inclusion criteria: inclusion criteria:

 Male and female children 2 months to 5 years of age scheduled to receive vaccination

Exclusion criteria: :

 Contraindications to Vaxem™Hib Korean Prescribing information

['Haemophilus influenza type b conjugate vaccine']

['Haemophilus Influenzae Type B Infection']


Train the Brain - Cognitive and Physical Training for Slowing Dementia

Summary: Train The Brain is aimed at assessing the efficacy of cognitive and physical training in slowing progression to dementia in patients diagnosed with mild cognitive impairment (MCI).
Inclusion criteria: inclusion criteria:

 Age between 65 and 89

 Successful completion of primary school

 MCI, as Mini Mental State Examination score between 20 and 27 and confirmation through neuropsychological examination by a specialist, according to current guidelines.

Exclusion criteria: :

 Moderate/severe dementia

 Clinical signs of depressive disorder or other primary psychiatric disorders

 Neoplastic diseases

 Neurologic or musculoskeletal deficits barring neuropsychological examination or physical or cognitive training

 Severe heart disease

 End stage renal disease (eGFR<35 ml/min(1.73 m2)

 Severe chronic obstructive pulmonary disease (COPD) and/or respiratory failure

 Complicated or decompensated diabetes

 Overt peripheral artery disease

 Any inability to successfully complete a brain magnetic resonance scan

 Epilepsy, drug addiction

 Current acute diseases or recent head trauma

['Mild Cognitive Impairment', 'Dementia', 'Memory Disorders']

Mild Cognitive Impairment
Dementia
Memory Disorders


Trastuzumab in Combination With Capecitabine and Oxaliplatin(XELOX) in Patients With Advanced Gastric Cancer(AGC): Her+XELOX

Summary: This is an open-label, multicentre, prospective phase II trial designed to evaluate the efficacy and safety of trastuzumab in combination with capecitabine and oxaliplatin as first-line therapy in patients with recurrent and/or metastatic HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction.
Inclusion criteria: inclusion criteria:

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

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

 HER2 positive tumour (primary tumour or metastasis) defined as either IHC2+ and FISH+ or IHC3+ according to the gastric cancer scoring system for HER2

 ECOG Performance status 0, 1 or 2

 Life expectancy of at least 3 months.

 Male or female. Age over 20 year.

 Signed informed consent.

Exclusion criteria: :

 Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study; adjuvant/neoadjuvant therapy with platinum is not allowed).

 Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g. patients with partial or total gastrectomy can enter the study, but not those with a jejunostomy tube).

 Patients with active (significant or uncontrolled) gastrointestinal bleeding.

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

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

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

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

 Creatinine clearance < 60 mL/min. Other Study Drug-Related

['Metastatic or Recurrent Gastric Adenocarcinoma', 'Her-2 Positive Gastric Cancer']


Sleep, Mood, and Behavior Study

Summary: The purpose of this study is to assess whether improving sleep in children and adolescents with anxiety disorder will further enhance affective, clinical, and social functioning.
Inclusion criteria: inclusion criteria:

 Clinical diagnosis of DSM-IV diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), and Social Phobia (SP)

 Previous enrollment Cognitive Behavioral Therapy arm in ClinicalTrials.gov Identifier: NCT00774150 study, entitled,  Transdisciplinary Studies of CBT for Anxiety in Youth: Child Anxiety Treatment Study (CATS)

 The child/adolescent must have a sleep problem defined as: difficulties at least 3 times within a 2-week period in one or more of the following domains:

 difficulties going to sleep

 difficulties waking during the night

 difficulties getting up on time for school because of tiredness/sleepiness

 daytime tiredness and/or irritability that the child or parent attributed to insufficient sleep

 erratic sleep-wake schedules

Exclusion criteria: :

 IQ below 70 as assessed by the Wechsler Abbreviated Scale of Intelligence (WASI).

 Requires current ongoing treatment with psychoactive medications including anxiolytics and antidepressants.

 Acutely suicidal or at risk for harm to self or others.

 Any motor impairments or eye-hand coordination problems

 Sleep disorder or parasomnia.

 Taking any medication that might interfere with sleep.

 Has a medical problem that might interfere with sleep.

['Sleep Difficulties in Pediatric Anxiety Disorder', 'Generalized Anxiety Disorder', 'Separation Anxiety Disorder', 'Social Phobia']


Immunogenicity and Safety Study of FSME-IMMUN 0.5 mL in Adult Subjects Previously Vaccinated According to a Rapid Immunization Schedule

Summary: The objective of this study is to investigate the immunogenicity and safety of FSME-IMMUN 0.5 ml in two age strata (stratum A: 16 to 49 years, stratum B: > 50 years), with the first and second vaccinations being administered according to a rapid immunization schedule (12 ± 2 days apart). The third vaccination will be administered approximately 6 months after the first dose.
Inclusion criteria: inclusion criteria:

 Male and female subjects will be eligible for participation in this study if they:

 Understand the nature of the study, agree to its provisions and provide written informed consent (assent if the subjects is under 18 years of age);

 Provide the written informed consent of their parents / legal guardian (if the subject is under 18 years of age);

 Are aged >= 16 years (from the 16th birthday) at screening;

 Are clinically healthy, (i.e. the physician would have no reservations vaccinating with FSME-IMMUN 0.5 ml outside the scope of a clinical trial);

 Have a negative pregnancy test result at the first medical examination (if female and capable of bearing children);

 Agree to employ adequate birth control measures for the duration of the study (if female and capable of bearing children);

 Agree to keep a Subject Diary.

Exclusion criteria: :

 Subjects will be excluded from participation in this study if they:

 Have a history of any previous tick-borne encephalitis (TBE) vaccination;

 Have a history of TBE infection;

 Have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, Japanese B-encephalitis);

 Have a history of allergic reactions, in particular to one of the components of the vaccine;

 Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions;

 Have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages);

 Have donated blood or plasma within 30 days of study entry;

 Have received a blood transfusion or immunoglobulins within 30 days of study entry;

 Are known to be HIV positive (an HIV test is not required specifically for the purpose of this study);

 Are simultaneously participating in another clinical trial including administration of an investigational product;

 Have participated in any other clinical study within six weeks prior to study entry;

 Are pregnant or breastfeeding (if female);

 Are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator.

 Have received any other vaccination within two weeks prior to study entry.

['Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl']


Pilot Study of ACTH in the Treatment of Immunoglobulin A (IgA) Nephropathy at High Risk of Progression

Summary: This study is designed to answer whether patients with progressive IgA nephropathy, who receive Acthar (ACTH) gel injection at a dose of 80 units subcutaneously twice weekly for 6 months is effective in inducing improvement in proteinuria and renal function.
Inclusion criteria: Inclusion:

 Proteinuria > 1000 mg/24h despite documented ACEi/ARB therapy and adequate blood pressure control for > 3 months.

 Quantified 24h creatinine clearance > 30 ml/min/1.73m2.

 Blood pressure < 130/80 mmHg at > 75% of the readings.

 Henoch Schoenlein Purpura (HSP): Patients with biopsy proven IgA nephropathy and clinical features consistent with Henoch Schonlein Purpura will be considered eligible for the study.

 Patient must be able to receive injections to be enrolled in the study.

 Patient must have a kidney biopsy slide on file - that can be sent to Mayo Clinic.

 Exclusion:

 Clinical and histologic evidence of IgA predominant Lupus nephritis

 Patients with greater than 50% glomerular senescence or cortical scarring on renal biopsy.

 Serum Cr > 3.0 mg/dL or creatinine clearance glomerular filtration rate (GFR) < 30 ml/min at the time of screening

 Patients with history of Crohn's disease or Celiac Sprue

 Clinical evidence of cirrhosis, chronic active liver disease.

 Known infection with hepatitis B, hepatitis C, or HIV (Patients will be serologically screened prior to study entry (if the rest has been completed in the last two years, the patient will not have to undergo additional testing).

 Active systemic infection with bacterial, viral, fungal, or mycobacterial or atypical mycobacterial infections (excluding fungal infections of nail beds).

 Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening.

 Positive pregnancy test or breast feeding at time of study entry (urine pregnancy test will be performed for all women of childbearing potential no later than 7 days prior to treatment) or patients unwilling to comply with contraceptive measures as outlined above.

 Patients receiving therapy with oral prednisone or glucocorticoid equivalent in the past 3 months.

 Patients who had received immunosuppressive therapy including cyclophosphamide, mycophenolate mofetil (MMF), cyclosporine, tacrolimus or azathioprine in the last 6 months.

 Current or recent (within 30 days) exposure to any investigational drug.

 Patients having received a live vaccine within 28 days of study enrollment.

 Hemoglobin: < 8.5 gm/dL

 Platelets: < 100,000/mm

 Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 2.5 x Upper Limit of Normal

 Patients with anaphylaxis and/or known allergic reactions to ACTH

 Previous Treatment with ACTH

 History of drug, alcohol, or chemical abuse within 6 months prior to screening

 Concomitant or previous malignancies, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.

 History of psychiatric disorder that would interfere with normal participation in this protocol.

 Significant cardiac or pulmonary disease (including obstructive pulmonary disease).

 Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication.

 Inability to comply with study and follow-up procedures.
Exclusion criteria:

['Progressive IgA Nephropathy', 'Proteinuria']


Blood Gene Expression Signature in Patients Diagnosed With Probable Alzheimer's Disease Compared to Patients Suffering From Other Types of Dementia

Summary: The objective of the study is to define the performance of blood-based signatures for Alzheimer's Disease (AD) in different patients populations including AD, non-AD dementia, and non-demented controls.
Inclusion criteria: inclusion criteria:

 AD group :

 Male or female patient, aged ≥ 40 years old included at entry.

 Patients having a clinical diagnosis of probable AD according to DSM-IV TR [F00.xx] and National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.

 Written informed consent obtained from the patient or, if appropriate, from legal representative according to local laws and regulations.

 Evidence that brain imaging (either cerebral CT-scan or cerebral MRI) was performed to settle the AD diagnosis, and that the results are compatible with AD diagnosis.

 Neurological exam without any particularities or without any specific focal signs likely to be related to other conditions than AD.

 Patient compliant with study procedures.

 Non AD demented group :

 Male or female patient, aged ≥ 40 years old included at entry.

 Patients having a clinical diagnosis of dementia which can be one of the following :

 VaD according to NINDS-AIREN criteria or,

 LBD according to McKeith's criteria, or,

 FTD according to Neary's or Lund & Manchester criteria or,

 PDD according to DSM-IV TR criteria [F02.x] or,

 Mixed dementia which is defined in this study as patients fulfilling DSM-IV TR criteria [F02.8] for dementia with multiple aetiologies focussing on dementia of Alzheimer type with secondary occurrence of vascular dementia.

 Written informed consent obtained from the patient or, if appropriate, from legal representative according to local laws and regulations.

 Evidence that brain imaging (either cerebral CT-scan or cerebral MRI) was performed to settle the diagnosis of dementia, and that the results are compatible with the diagnosis of dementia.

 Absence of other signs or symptoms that may be better related to another type of dementia than the current dementia diagnosis.

 Patient compliant with study procedures.

 Cognitive impairment-free control group :

 Male or female subject, aged ≥ 60 years old included at entry.

 Written informed consent obtained from the subject.

 Absence of spontaneously reported significant cognitive complaints from the subject at entry.

 MMSE ≥ 27 at entry.

 Subject with no impairment in daily living activities.

 Subject compliant with study procedures.

Exclusion criteria: :

 AD group :

 Any pathology, medical condition or symptoms that may lead to reconsider the initial diagnosis of probable AD, or that may rend the initial diagnosis of probable AD doubtful at entry, according to the opinion of the investigator.

 Current or recent history of drug or alcohol abuse or dependence.

 Diagnostic of Mild Cognitive Impairment defined by subjective complaints from the patient regarding memory and/or cognitive symptoms, objective memory and/or cognitive impairment at testing but not meeting AD diagnostic criteria, and not affecting daily living activities.

 Current diagnosis of brain tumour.

 Any current pathology or medical condition, for which blood sampling may involve a risk for the patient's health, according to the opinion of the investigator.

 Pregnancy.

 Patient who is not registered at Sécurité Sociale.

 Current participation in another study using an investigational non-marketed product.

 Non-AD demented group :

 Any pathology, medical condition or symptoms that may lead to reconsider the initial diagnosis of dementia the patient is suffering from, or that may rend the initial diagnosis of dementia doubtful at entry, according to the opinion of the investigator.

 Diagnostic of Mild Cognitive Impairment defined by subjective complaints from the patient regarding memory and/or cognitive symptoms, objective memory and/or cognitive impairment at testing but not meeting the diagnostic criteria for dementia, and not affecting daily living activities.

 Current diagnosis of brain tumour.

 Any current pathology or medical condition for which blood sampling may involve a risk for the patient's health, according to the opinion of the investigator.

 Current or recent history of drug or alcohol abuse or dependence.

 Pregnancy.

 Patient who is not registered at Sécurité Sociale.

 Current participation in another study using an investigational non-marketed product.

 Cognitive impairment-free control group :

 Subject spontaneously complaining from significant cognitive impairment.

 Known family history of dementia.

 Diagnosis of any type of dementia (either AD or non-AD dementia), Mild Cognitive Impairment, or any current or past history of CNS pathology (including but not limited to brain injury, brain tumour, stroke, normal pressure hydrocephalus, Parkinson's disease, epilepsy, multiple sclerosis,…) that may be responsible for the occurrence of dementia.

 History or current clinically significant psychiatric pathology (including but not limited to psychotic disorders, bipolar disorder, personality disorders).

 Current major depressive disorder, either treated or not, associated with clinically significant symptoms.

 Any current pathology or medical condition for which blood sampling may involve a risk for the subject's health, according to the opinion of the investigator.

 Current or recent history (within one month) of clinically significant pathology, medical condition (including hospitalization) or symptoms. However, chronic diseases or medical conditions which are considered stable are accepted, provided that they are compatible with other study selection criteria.

 Current or recent history of drug or alcohol abuse or dependence.

 Subject who is not registered at Sécurité Sociale.

 Current participation in another study using an investigational non-marketed product.


Efficacy of T1675 Versus Placebo in Patients With Bilateral Treated Moderate Dry Eye Syndrome

Summary: To evaluate the efficacy of a 6-month (± 14 days) dietary supplementation period with T1675, a per os omega 3 and omega 6 polyunsaturated essential fatty acid dietary formulation, versus placebo in patients with bilateral treated moderate dry eye syndrome
Inclusion criteria: inclusion criteria:

 Signed and dated informed consent.

 Male or female aged from 18 to 90 years old.

 Known treated bilateral dry eye.

 Dry eye syndrome confirmed by ocular examination with a fluorescein and/or lissamine green staining, BUT and Schirmer, performed within the last 12 months before Inclusion Visit, for both eyes.

 Bilateral symptomatology suggestive of dry eye defined by: at least one of the following ocular symptoms suggestive of dry eye (burning, stinging, dryness feeling, sandy and/or gritty sensation, light sensitivity, reflex tearing, ocular fatigue) and Questioning on patient's feeling (score >=3).

 Fulfilling the following criteria of dry eye syndrome in both eyes defined by: Keratoconjunctivitis defined by a lissamine green score ≥ 4 (Van Bijsterveld score) and Schirmer test <= 10 mm in 5 min or BUT < 10 s

Exclusion criteria: :

 severe dry eye symptom

 eyelid dysfunction

 severe progressive rosacea

 any relevant ocular anomaly interfering with ocular surface

 best corrected far visual acuity <= 1/10

 history of ocular allergy

 traumatism, infection, inflammation within last 3 months

 ocular surgery and laser within the last 3 months

 lasik, laser, PKR within the last 12 months

 contact lenses

 any concomitant nutritive supplementation, vitamins

 any topical concomitant treatment


Hypertonic Resuscitation Following Traumatic Injury

Summary: The purpose of this study is to determine if hypertonic saline with and without dextran can improve overall survival in victims of trauma with shock.~Injury and lost blood from trauma can cause your body to be in shock (low blood pressure related to blood loss). This decreased blood flow can lead to organ damage. In order to restore the blood pressure and blood flow, the medics give fluids into the patients' veins as soon as possible. This is called resuscitation. The resuscitation fluid most commonly used is isotonic or one that is the same concentration as the blood. The investigators are trying to determine if infusing a hypertonic fluid (or one more concentrated than the blood) can increase the blood pressure and restore blood flow more efficiently. The hypertonic fluids the investigators are using are called hypertonic saline with dextran (HSD) and hypertonic saline (no dextran). Hypertonic saline is a salt solution that is slightly more concentrated than your blood. Dextran is a sugar solution.
Inclusion criteria: inclusion criteria:

 Blunt or penetrating trauma

 Prehospital Systolic Blood Pressure (SBP) <= 70;OR

 Prehospital SBP 71-90 AND Hear Rate (HR) ≥108

 15 years of age or older, or 50kg or more if age unknown

Exclusion criteria: :

 Known or suspected pregnancy

 Age younger than 15 or less than 50kg if age unknown

 Ongoing prehospital cardiopulmonary resuscitation (CPR)

 Administration of more than 2000cc crystalloid or any colloid or blood products

 Severe hypothermia (suspected Temperature less than 28 degrees celsius)

 Drowning or asphyxia due to hanging

 Burns Total Body Surface Area (TBSA) more than 20%

 Isolated penetrating injury to the head

 Inability to obtain prehospital intravenous access

 Time of call received at dispatch to study intervention greater than four hours

 Known prisoners

['7.5% hypertonic saline/6% Dextran-70 (HSD)', '7.5% hypertonic saline (HS)', '0.9% normal saline']


Hemospray Versus the Combined Conventional Technique for Endoscopic Hemostasis of Bleeding Peptic Ulcers : A Pilot Study

Summary: Hemospray (TC-325, Cook Medical Inc, Winston-Salem, NC, USA), a new adsorptive nanopowder hemostatic agent for endoscopic treatment of high-risk bleeding peptic ulcers, provides significant ease of administration compared to the combined conventional technique of saline-adrenaline injection with mechanical clip or heater probe applications. The Hemospray powder is easily applied on ulcers at difficult endoscopic positions and ulcers with fibrotic bases, where the combined conventional technique has limited efficacy. Building up on preliminary work from small single-arm studies, the investigators aim to establish the efficacy and safety of Hemospray in treating bleeding peptic ulcers in comparison with the combined conventional technique. The investigators propose a pilot study to establish our centre's feasibility of performing a prospective, randomized, parallel group trial, which compares the efficacy of Hemospray with the combined conventional technique, in the endoscopic treatment of high-risk bleeding peptic ulcers. Patients with high-risk bleeding peptic ulcers will be treated with Hemospray to determine its initial hemostasis rate (defined as endoscopically verified cessation of bleeding for at least 5 minutes after endoscopic treatment), rebleeding rate (recurrent hemorrhage during a 4-week period following the initial hemostasis) and its safety profile.
Inclusion criteria: inclusion criteria:

 Peptic ulcer with high-risk stigmata of recent hemorrhage (Forrest class IA, IB, IIA and IIB)

Exclusion criteria: :

 Patients younger than 21 years of age

 Refusal to participate in study

 Contraindicated for endoscopy

 Pregnant or lactating patients

 Bleeding secondary to non-peptic ulcer source

 Patients requiring mechanical ventilation

 Patients with acute coronary syndrome

['Hemospray', 'Combined Conventional Technique']

Hemospray
Combined Conventional Technique


Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass

Summary: Prospective randomized clinical trial aiming to compare laparoscopic Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) with primary outcome on excess weight loss, and secondary outcomes on nutritional status, glycolipid profile, quality of life and pain assessments.
Inclusion criteria: inclusion criteria:

 BMI >40 and < 60 kg/m2

 No contraindication to any of the procedures

 No contraindication to general anesthesia

 No known addiction

 Patient able to provide informed consent

Exclusion criteria: :

 Contraindication to general anesthesia

 Known psychiatric pathology

 Pregnancy

 Previous major digestive surgery

 Immunosuppressive treatment including corticoids

 Coagulopathy (INR>1.5) or platelets < 50 000/µl

 Anemia (Hb<10g/dl)

 Severe comorbidity

 Malabsorptive disease or gastro-intestinal disease

 Myocardial infarction in previous year, angina, cardiac failure

['Laparoscopic sleeve gastrectomy', 'Laparoscopic Roux-en-Y gastric bypass']

Laparoscopic sleeve gastrectomy
Laparoscopic Roux-en-Y gastric bypass


Lyophilized Black Raspberries in Adults With Familial Adenomatous Polyposis (FAP)

Summary: This is a 36 week dietary intervention pilot study to evaluate the effects of lyophilized black raspberries on rectal polyp burden and biomarkers in subjects with FAP. Subjects will undergo a colonoscopy or sigmoidoscopy before study treatment to determine eligibility for the study. Eligible participants will undergo a sigmoidoscopy at 36 weeks after the initiation of study treatment. The size and number of rectal polyps will be documented on a code sheet and by photograph. The efficacy outcome will include the percentage reduction in the number of rectal polyps between baseline and 36 weeks.
Inclusion criteria: inclusion criteria:

 Diagnosis of familial adenomatous polyposis with at least 5 rectal polyps which are greater than or equal to 2 mm on baseline colonoscopy

 Have an endoscopically assessable rectal segment

 Have not taken NSAIDs or selective COX-2 inhibitors for two months prior to the study and willing to remain off NSAIDs for the study duration.

Exclusion criteria: :

 Known allergies or hypersensitivity to berries

 Diabetes mellitus

 Subjects taking NSAIDs or COX-2 inhibitors who cannot be taken off the medication due to their clinical condition.

['Black raspberry (BRB) Slurry', 'Black Raspberry (BRB) Suppositories', 'Black Raspberry (BRB) Placebo Slurry']

Black raspberry (BRB) Slurry
Black Raspberry (BRB) Suppositories
Black Raspberry (BRB) Placebo Slurry


X-Ray Computed Tomography and Blood Reactive Oxygen Species Level

Summary: The clinically widely used X-ray computed tomography examination has a low-grade radiation effect and recently has attracted much attention concerning the possible adverse effects of radiation on human body [ref. 1-5]. The radiation is harmful to human tissues and cells mainly because it can interact with water (which makes up to 80% of cells) to generate reactive oxygen species (ROS), especially the formation of hydroxyl radicals. So far as we can reach, there is no report concerning the relation between X-ray computed tomography examination and the blood ROS concentration. Therefore, we wish to conduct this study to clarify if the routinely applied X-ray computed tomography examination may induce a higher concentration of ROS in the peripheral blood.~Study subjects will be participants of health check program at our hospital. The only enrollment condition will be a scheduled X-ray computed tomography examination for either lung (20 cases) or heart (20 cases) of the study subject. Another 20 participants receiving health check program without X-ray computed tomography examination will be included as the control group. The formal consent will be delivered to the participants of health check program several days before their admission for health check and will be retrieved before the proceeding of health check.~Measurements and comparison of ROS concentration will be performed in the sampled peripheral blood before and after the performance of X-ray computed tomography examination during a regular health check program. Totally 120 blood samples will be collected from included 60 study subjects within 3 months. Reactive oxygen species（ROS）levels will be measured by a chemiluminescence (CL) analysing system (CLD-110, Tohoku Electronic Industrial, Sendai, Japan).
Inclusion criteria: inclusion criteria:

 Participants of health check program at our hospital who will receive a scheduled X-ray computed tomography examination for either lung (20 cases) or heart (20 cases).

Exclusion criteria: :

 Those whose age are under 50 or above 70 year-olds will be excluded.


Impact of Keeping a Personal Recovery Diary on Upper Extremity Disability

Summary: Primary null hypothesis:~• Keeping a personal diary has no effect on upper-extremity disability (assessed w/ PROMIS [Patient Reported Outcome Measurement Information System] upper extremity) 8 weeks after injury.~Secondary null hypotheses:~Keeping a personal diary has no effect on avoidance of painful activities (assessed w/ PROMIS pain interference) 8 weeks after injury.~Keeping a personal diary has no effect on symptoms of depression (assessed w/ PROMIS depression) 8 weeks after injury.~There are no factors associated with upper-extremity disability 8 weeks after injury.
Inclusion criteria: inclusion criteria:

 All new patients (>18 years) with an acute injury of the upper extremity (fracture, laceration, sprain, contusion)

 English fluency and literacy

 Able to take informed consent

Exclusion criteria: :

 Pregnant women


Study of Efficacy and Safety of Privigen in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy

Summary: The objective of this study is to demonstrate the efficacy and safety of Privigen in subjects with CIDP.
Inclusion criteria: inclusion criteria:

 IVIG-untreated subjects:

 Either subjects with newly diagnosed CIDP (developing over at least 2 months) or subjects with an IVIG treatment interruption for at least 1 year with a progressive disease (deteriorating in the last 2 months) prior to enrolment.

 Actual diagnosis (including electrophysiology) of CIDP with progressive or relapsing dysfunction from motor and sensory or symmetric motor nerve only in at least 1 limb resulting from neuropathy. Criteria for definite or probable CIDP according to EFNS/PNS guideline.

 Age ≥18 years.

 Male or female.

 Written informed consent for study participation obtained before undergoing any study specific procedures.

 IVIG-pretreated subjects:

 Being treated regularly with IVIG on a fixed cycle length of 2 to 6 weeks ± 5 days in the last 6 months, on a fixed dosage of ± 20 % in the last 6 months and deteriorating by at least 1 INCAT score point during the Washout Period of up to 10 weeks (except for an increase from 0 to 1 solely due to upper limb score).

 Historic diagnosis of CIDP with progressive or relapsing dysfunction from motor and sensory or symmetric motor nerve only in at least 1 limb resulting from neuropathy. Criteria for definite or probable CIDP according to EFNS/PNS guideline.

 Age ≥18 years.

 Male or female.

 Written informed consent for study participation obtained before undergoing any study specific procedures.

Exclusion criteria: :

 A motor syndrome that fulfils criteria for multifocal motor neuropathy (MMN) with conduction block (i.e., upper limb motor weakness without sensory deficit and with a 50% decrease in action potential amplitude or area on proximal compared with distal stimulation in motor nerves).

 CIDP with monoclonal gammopathy of uncertain significance (CIDP-MGUS) with anti-MGUS antibodies and patients with distal acquired demyelinating symmetric (DADS)neuropathy.

 Any disease (mainly neurological or chronic orthopedic) that may cause symptoms or may interfere with treatment or outcome assessments with the INCAT (e.g., diphtheria, drug or toxin exposure and diabetes mellitus likely to have caused the neuropathy, IgM paraproteinemia, familial neuropathy, borreliosis with radiculopathy, post-polio-syndrome,M. Parkinson, stroke).

 Current malignancy.

 History of cardiac insufficiency (New York Heart Association [NYHA] III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease, congestive heart failure or severe hypertension.

 History of thrombotic episodes (deep vein thrombosis, myocardial infarction, cerebrovascular accident).

 Migraine associated with IVIG infusion in the last 3 months prior to enrolment.

 Known allergic or other severe reactions to blood products including intolerability to previous IVIG (i.e. severe headache, hypersensitivity, intravascular hemolysis).

 Subjects with serum IgA level less than 50% of the lower normal limit.

 Known hyperprolinemia.

 Any condition (including alcohol, drug or medication abuse) that is likely to interfere with evaluation of the study product or satisfactory conduct of the study.

 Plasma exchange 3 months prior to enrolment.

 Treatment with immunomodulatory agents others than steroids, methotrexate or azathioprine (e.g. interferon, TNF-α inhibitors) within 6 months before enrolment.

 Treatment with rituximab in the 12 months before enrolment.

 Abnormal laboratory parameters: creatinine > 1.5 times the upper normal limit (UNL), lactate dehydrogenase (LDH) > 1.5 times the UNL, C-reactive protein (CRP) > 1.5 times the UNL, hemoglobin (Hb) < 10 g/dL.

 Ongoing HIV, hepatitis C and hepatitis B infection.

 Participation in another clinical study (or use of another investigational medicinal product [IMP]) within 3 months prior to enrolment

 Not able to comply with study procedures and treatment regimen.

 Employee at the study site, or spouse/partner or relative of any study staff (e.g., investigator, sub-investigators, or study nurse).

 Pregnancy or nursing mother.

 Intention to become pregnant during the course of the study.

 Female subjects of childbearing potential either not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study, or not sexually abstinent for the entire duration of the study, or not surgically sterile.

['10% liquid formulation of human immunoglobulin']

['Chronic Inflammatory Demyelinating Polyneuropathy']


Impact of Impaired Cerebral Autoregulation on Postoperative Delirium in Elderly Patients Undergoing Spine Surgery

Summary: Delirium (confusion) after surgery is common and associated with a longer hospitl stay and increased hopsital cost. There is very little information available about how often delirium occurs and the complications associated with it. Elderly patients are at high risk for delirium after surgery. This research is being done to measure how often delirium after spine surgery occurs and to see if there are ways to predict if delirium will develop. The results from this study will provide important information on a possible mechanism and predictor of delirium.
Inclusion criteria: inclusion criteria:

 ≥ 70 years old,

 Undergoing any lumbar spine surgery, posterior cervical spine surgery, or anterior cervical spine surgery > 2 levels

Exclusion criteria: :

 MMSE < 15

 Delirium at baseline

 Inability to speak and understand English

 Severe hearing impairment, resulting in inability to converse.

 Planned use of intraoperative ketamine

 Planned use of intraoperative remifentanil, except for airway management pre-incision.

 Arterial catheter not planned to be inserted


Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Summary: RATIONALE: Drugs used in chemotherapy, such as mitoxantrone, cytarabine, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.~PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed acute myeloid leukemia.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Diagnosis of acute myeloid leukemia

 Previously untreated disease

 Previous hydroxyurea and/or corticosteroids are acceptable

 No preexisting history of a hematologic disorder

 Myelodysplastic features allowed

 No acute leukemia secondary to previous therapy

 No leukemic meningitis

 PATIENT CHARACTERISTICS:

 Bilirubin < 2.0 mg/dL (unless felt to be increased because of hepatic infiltration with leukemia)

 Creatinine < 2.0 mg/dL

 Pregnant or lactating patients are ineligible

 Fertile patients must use effective contraception

 No history of or active congestive heart failure

 PRIOR CONCURRENT THERAPY:

 See Disease Characteristics
Exclusion criteria:

['filgrastim', 'cytarabine', 'etoposide', 'mitoxantrone hydrochloride']

filgrastim
cytarabine
etoposide
mitoxantrone hydrochloride


Sodium Stibogluconate Treatment of Leishmaniasis

Summary: Leishmanias is a disease caused by the bite of sandflies and is found in many parts of the world including the Europe, Southwest Asia, Africa and the Middle East. This disease is a threat for military soldiers in areas where this disease is found. Sodium stibogluconate (SSG) or Pentostam (Glaxo Smith Kline, United Kingdom) is an Investigational New Drug (IND) product used by the Department of Defense for over 20 years to treat cutaneous, mucosal and viseral leishmanias. This drug is not licensed for commercial use in the United States because of very limited need for the product in the U.S.A. The objective of this protocol is to provide sodium stibogluconate for the treatment of cutaneous leishmaniasis and mucosal leishmaniasis (pentavalent antimonials curently considered the drug of choice for these infections) Provide sodium stibogluconate as a second line treatment for viscerotropic and visceral leishmaniasis (liposomal amphotericin is the drug of choice for these types as it is FDA approved for vusceral leishmaniasis).
Inclusion criteria: inclusion criteria:

 DoD healthcare beneficiary of any age and gender.

 Clinicoepidemiologic or parasitologic diagnosis (microscopy, PCR or culture) of Leishmania infection.

 Able to provide informed consent or assent (children).

 All participants (both male and female) must agree to take precautions not to become pregnant or father a child for at least 2 months after receiving SSG.

Exclusion criteria: :

 Pregnancy. Females of childbearing potential must have negative urine human chorionic gonadotropin hormone (HCG) within 96 hours start of infusion period.

 History of hypersensitivity to pentavalent antimonials.

 Any of the following on screening examination:

 QTc interval greater or equal to 0.5 sec

 Severe cardiac disease (disabling valvular heart disease, myopathy, or arrhythmias)

 History of recurrent pancreatitis

 Liver failure or active hepatitis with transaminases > 3x upper limit of normal

 Renal failure or creatinine > 2.5 mg/dL

 Thrombocytopenia (platelets <100,000/mm3)

 White blood cell count < 2000 / mm3

 Hematocrit < 30 %


Phase III Trial to Evaluate Efficacy and Safety of a Tetravalent Dengue Vaccine

Summary: This is a randomized, multicenter, double-blind, placebo-controlled Phase III study that will evaluate efficacy and safety of a live attenuated, tetravalent, lyophilized dengue vaccine produced by Butantan Institute.~The study will be carried out in multiple sites in Brazil. The study will be community-based in select urban areas where there's dengue transmission.~Study's intervention will be a single dose of the tetravalent dengue vaccine or placebo in a ratio 2:1. For efficacy analysis will be considered all dengue cases occurring after 28 days post-vaccination in the entire population of 16944 participants.~For safety analysis participants will be divided in three age groups: 18 to 59 ys, 7-17 ys and 2 to 6 ys. In each of these age groups there will be a minimum of 4992 participants. The age groups of 18 to 59 ys and 7 to 17 ys will start first. Once safety data for the first 21 days after vaccination is analysed for 450 participants in 7-to17-ys age group, the following group, of 2 to 6 ys, will start.~The study's hypothesis is that the vaccine under investigation and produced by Butantan Institute is safe and provides protection against dengue symptomatic disease of 80% or more with a lower bound of the 95% confidence interval of 25%. This way, the expected number of dengue cases virologically confirmed is 24 or more which will provide a response in terms of vaccine efficacy.~All participants will be followed up for five years to verify dengue incidence, regardless severity.
Inclusion criteria: inclusion criteria:

 Children who have completed 24 months of age, adolescents and adults who have not completed 60 years of age;

 Agree with periodic contacts, either/or by phone, electronic means, and home visits.

 Show voluntary intention to participate in the study, documented by the participant's or participant's legal representative's signature of the informed consent form.

Exclusion criteria: :

 For women: Pregnancy (confirmed by positive beta-hCG test) or breastfeeding;

 Evidence of active neurological, cardiac, pulmonary, hepatic or renal disease as per clinical history and/or physical examination;

 Compromised immune system diseases including: decompensated diabetes mellitus, cancer (except basal cell carcinoma), congenital or acquired immune deficiencies and not controlled autoimmune, as per clinical history and/or physical examination;

 Behavioral, cognitive or psychiatric disease that in the opinion of the principal investigator or his representative physician, affects the participant ability to understand and cooperate with all study protocol requirements;

 Abusive usage of alcohol or drugs in the past 12 months that has caused medical, professional or family problems, indicated by clinical history;

 History of severe allergic reactions or anaphylaxis to the vaccine or to components of the vaccine in study;

 History of asplenia;

 Use of any investigational product within 28 days before or after receiving this study vaccination;

 Has participated in another clinical trial six months prior to inclusion in the study or planning to participate in another clinical trial within 2 years following inclusion;

 Use of immunosuppressant drugs such as: antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use (except topical or nasal). For this protocol will be considered for exclusion use of corticosteroids 3 months prior to the inclusion in the study and 6 months prior to the inclusion for the other therapies mentioned, and planned use of any immunosuppressant therapy within 2 years following inclusion in the study. It will be considered immunosuppressive dose of corticosteroids the equivalent to a dose ≥20 mg of prednisone per day for adults and the equivalent of prednisone at 2 mg/kg/day for children for over 7 days;

 Have received blood products in the past three months, including transfusions or immunoglobulin, or scheduled administration of blood products or immunoglobulin for the following 2 years after vaccination;

 Fever or suspected fever within 72 hours prior to vaccination or axillary temperature greater than 37,8°C on the day of vaccination (inclusion might be postponed until participant has completed 72 hours of no fever);

 Have received live virus vaccine within 28 days or killed virus vaccine in the last 14 days prior to vaccination, or have a scheduled immunization during the first 28 days after receiving the investigational product;

 Any other condition that might put in risk the safety/rights of a potential participant or hurdle his/her compliance with this protocol in investigator's opinion or his representative physician.

['Dengue 1,2,3,4 (attenuated) vaccine', 'Placebo']

Dengue 1,2,3,4 (attenuated) vaccine
Placebo


Concurrent Hyperthermia and Chemoradiotherapy in LAPC: Phase II Study

Summary: This is a phase II randomized study of concurrent chemoradiotherapy and local hyperthermia (study group) versus chemoradiotherapy alone (control group) following neoadjuvant chemotherapy in locally advanced pancreatic cancer. Each of the treatment arm would have 39 patients based on the expected overall 1 year survival advantage of +20% over the control group (p0=40%).
Inclusion criteria: inclusion criteria:

 Patients of locally advanced pancreatic cancer with

 Major venous infiltration / thrombosis of the portal vein or superior mesenteric vein extending for several centimeters

 Tumor encasement (≥180°) of the superior mesentric artery or proximal hepatic artery

 Tumor abutment (<180°) of the celiac trunk

 Tumor invasion of the aorta

 Presence of metastasis to lymph nodes beyond the field of resection

 Histopathologically proven ductal adenocarcinoma of the pancreas (biopsy /cytology)

 Eastern Cooperative Oncology Group (ECOG) performance scale 0 and 1

 Age: 18 to 80 years

 At least one of the diameters of the primary tumor or regional lymph node or both should be greater than 4 cm, as confirmed on contrast-enhanced computed tomography (CECT).

 Patients, have primary tumor or regional lymph node or both lesser than 4 cm, as confirmed on CECT but have specific medical contraindications to stereotactic body radiation therapy or irreversible electroporation or as per patient's preference could be considered for HEATPAC.

 No evidence of any distant metastasis

 Patients with microscopic peritoneal carcinomatosis, detected on laparoscopy following 4 cycles on neo-adjuvant FOLFIRINOX would be included.

 Estimated life expectancy of at least 6 months

 Adequate kidney functionality defined as creatinine clearance >50ml/min

 Adequate liver functionality defined as total bilirubin ≤ 2x of the upper limit of normal

 Adequate bone marrow reserves: White blood cell count ≥ 2.5 x 10˄9/L, Platelet count ≥ 100 x 10˄9/L, Hemoglobin ≥ 8.0g/L

 Women of child-bearing age must secure sufficient contraception control during the clinical trial and six months after the clinical trial is completed

 For females of child bearing potential, negative pregnancy test within 2 week prior to randomization.

 Female patients should not be lactating

 Absence of psychological, familial, sociological or geographical condition that could potentially hamper compliance with the study protocol and follow-up schedule

Exclusion criteria: :

 Histopathology other than ductal adenocarcinoma pancreas

 Prior radiotherapy to the site of treatment

 Patients with unequivocal distant metastasis including liver

 Patients with gross peritoneal carcinomatosis on laparoscopy

 No prior or concurrent malignancies other than surgically treated squamous cell or basal cell carcinoma of the skin

 No serious medical illness which would prevent informed consent or limit survival to less than 2 years

 Active uncontrolled bacterial, viral or fungal infections until these conditions are corrected or controlled.

 Psychiatric or addictive disorders or other conditions that would preclude the patient from meeting the study requirements.

 Patients having metal implants, pacemakers or clustered markers.

 Metallic endobiliary stenting would be a contraindication, hence plastic stents may be used if biliary drainage is indicated.

 Patient with a history of myocardial infarction within the past 12 months

 No connective disease disorders that contraindicate radiotherapy, e.g., Scleroderma

 Pre-existing grade 2 peripheral neuropathy

 Any known contraindication or hypersensitivity to the chemotherapeutic agents

 Pregnancy, lactation period or lack of reliable contraception

 Any other disease or therapy, which, present a risk to the patient or which are not compatible with the aims of the clinical trial

 Patients would express their inability to travel on their own to Kantonsspital Aarau, (KSA) for hyperthermia treatment

 Indications that the person concerned will be noncompliant to the clinical trial plan because of unwillingness to cooperate or difficulties in keeping the check-up appointments

['Chemoradiotherapy (CTRT)', 'Thermochemoradiotherapy (CTRTHT)']

Chemoradiotherapy (CTRT)
Thermochemoradiotherapy (CTRTHT)


Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)

Summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients of black race with systemic lupus erythematosus (SLE; lupus).
Inclusion criteria: inclusion criteria:

 At least 18 years of age.

 Self-identified black race.

 Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) criteria

 Have active SLE disease defined as a SELENA SLEDAI score >= 8 at screening

 Have 2 unequivocally positive autoantibody test results defined as a positive antinuclear antibody (ANA) test [i.e., titer >= 1:80 by human epithelial cell line 2 (HEp-2) immunofluorescence assay (IFA) and/or positive enzyme immunoassay (EIA)] and/or a positive anti- double stranded deoxyribonucleic acid (dsDNA) (>= 30 international units [IU]/milliliter [mL]) serum antibody test as follows:

 From 2 independent time points within the study screening period. Screening results must be based on the study's central laboratory results, OR

 One positive historical test result and 1 positive test result during the screening period.

 Historical documentation of a positive ANA test (e.g., HEp-2 IFA or EIA) or anti-dsDNA (eg, anti-dsDNA by any validated commercial assay) must include the date and type of the test, the name of the testing laboratory, numerical reference range, and a key that explains values provided as positive versus negative OR negative, equivocal/borderline positive). Only unequivocally positive values as defined in the laboratory's reference range are acceptable; borderline values will not be accepted.

 On a stable SLE treatment regimen consisting of any of the following medications (alone or in combination) for a period of at least 30 days prior to Day 0 (i.e., day of 1st dose of study agent):

 Corticosteroids (prednisone or prednisone equivalent, up to 40 mg/day): For subjects on SLE combination therapy, their stable steroid dose must be fixed within the range of 0 to 40 mg/day (prednisone or prednisone equivalent). For subjects whose only SLE treatment is steroids, their stable steroid dose must be fixed within the range of 7.5 to 40 mg/day (prednisone or prednisone equivalent). For those subjects on alternating day doses of steroids, use the average of 2 daily doses to calculate the average daily steroid dose.

 Other immunosuppressive or immunomodulatory agents including methotrexate, azathioprine, leflunomide, mycophenolate (including mycophenolate mofetil, mycophenolate mofetil hydrochloride, and mycophenolate sodium), calcineurin inhibitors (e.g., tacrolimus, cyclosporine), sirolimus, oral cyclophosphamide, 6-mercaptopurine, mizoribine, or thalidomide.

 Anti-malarials (e.g., hydroxychloroquine, chloroquine, quinacrine).

 Non-steroidal anti-inflammatory drugs (NSAIDs).

 Note:

 Pre-existing SLE medications must be stable for at least 30 days prior to Day 0.

 Corticosteroids may be added as new medication or their doses adjusted only up to 30 days prior to Day 0.

 New SLE therapy other than corticosteroids must not be added within 60 days of Day 0.

 A female subject is eligible to enter the study if she is:

 Not pregnant or nursing;

 Of non-childbearing potential defined as: pre-menopausal females with a documented tubal ligation, hysterectomy, documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, or documented bilateral oophorectomy, OR postmenopausal defined as 12 months of spontaneous amenorrhea with an appropriate clinical profile [e.g., > 45 years, in the absence of hormone replacement therapy or other cause for amenorrhea]; in questionable cases obtain a blood sample for follicle stimulating hormone (FSH) and estradiol simultaneously to confirm. Diagnostic levels for FSH and estradiol vary by specific laboratories/assays;

 OR is of child-bearing potential with negative pregnancy test as determined by serum human chorionic gonadotrophin (hCG) test at screening and urine hCG test prior to dosing AND agrees to use one of the contraception methods for 2 weeks prior to the day of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 16 weeks following the last dose of study agent.

 OR has only same-sex partners, when this is her preferred and usual lifestyle.

 Have the ability to understand the requirements of the study, provide written informed consent (including consent for the use and disclosure of research-related health information), and comply with the study protocol procedures (including required study visits).

Exclusion criteria: :

 Have received treatment with anti-B lymphocyte stimulator (BLyS) [belimumab] at any time.

 Have received any of the following within 364 days of Day 0:

 Abatacept

 Other B cell targeted therapy (e.g., rituximab, other anti-cluster of differentiation [CD] 20 agents, anti-CD22 [epratuzumab], anti-CD52 [alemtuzumab], BLyS-receptor fusion protein [BR3], TACI-Fc, or anti-B-cell activating factor [BAFF] (LY2127399).

 A biologic investigational agent other than B cell targeted therapy (e.g., abetimus sodium, anti-CD40L antibody [BG9588/IDEC-131]).

 Have required 3 or more courses of systemic corticosteroids for concomitant conditions (e.g., asthma, atopic dermatitis) within 364 days of Day 0. (Topical or inhaled steroids are permitted.)

 Have received any of the following within 90 days of Day 0:

 Anti-tumor necrosis factor (TNF) therapy (eg, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab).

 Intravenous (IV) cyclophosphamide

 Interleukin-1 receptor antagonist (anakinra).

 Intravenous immunoglobulin (IVIG).

 High dose prednisone or equivalent (> 100 mg/day).

 Plasmapheresis.

 Have received any of the following within 60 days of Day 0:

 A non-biologic investigational agent.

 Any new immunosuppressive/immunomodulatory agent, anti-malarial, or NSAID Note: New inhaled and topical steroids and new topical immunosuppressive agents (e.g., eye drops, topical creams) are allowed. Any NSAID use for < 1 week is allowed.

 Any steroid injection (e.g., intramuscular, intraarticular, or intravenous).

 Have received any of the following within 30 days of Day 0:

 A live vaccine.

 A change in dose of a corticosteroid, other immunosuppressive/immunomodulatory agent, anti-malarial, or NSAID

 Have severe lupus kidney disease (defined by proteinuria > 6 grams/24 hour or equivalent using spot urine protein to creatinine ratio, or serum creatinine > 2.5 mg/deciliter [dL]), or have severe active nephritis requiring acute therapy not permitted by protocol (e.g., IV cyclophosphamide within 90 days of Day 0), or have required hemodialysis or high-dose prednisone (> 100 mg/day) within 90 days of Day 0.

 Have severe active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident [CVA], cerebritis, or CNS vasculitis) requiring therapeutic intervention within 60 days of Day 0.

 Have a history of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.

 Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy, or infectious diseases) which, in the opinion of the principal investigator, could confound the results of the study or put the subject at undue risk.

 Have a planned surgical procedure or a history of any other medical disease (e.g., cardiopulmonary), laboratory abnormality, or condition (e.g., poor venous access) that, in the opinion of the principal investigator, makes the subject unsuitable for the study.

 Have a history of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix.

 Have required management of acute or chronic infections, as follows:

 Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, and atypical mycobacteria).

 Hospitalization for treatment of infection within 60 days of Day 0.

 Use of parenteral (IV or intramuscular [IM]) antibiotics (antibacterials, antivirals, anti-fungals, or anti-parasitic agents) within 60 days of Day 0.

 Subjects who have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months and/or any suicidal ideation of type 4 or 5 on the screening Columbia-Suicide Severity Rating Scale (C-SSRS) in the last 2 months or who, in the investigator's opinion, pose a significant suicide risk.

 Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Day 0.

 Have a historically positive test or test positive at screening for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis B core antibody, or hepatitis C antibody.

 Have an immunoglobulin (Ig)A deficiency (IgA level < 10 mg/dL).

 Have a grade 3 or greater laboratory abnormality based on the adverse event

 Severity grading tables except for the following that are allowed:

 Stable grade 3 prothrombin time (PT) secondary to anticoagulant, e.g., warfarin, treatment.

 Stable grade 3 partial thromboplastin time (PTT) due to lupus anticoagulant and not related to liver disease or anti-coagulant therapy.

 Stable grade 3/4 proteinuria (<=6 grams/24 hour equivalent by spot urine protein to creatinine ratio allowed).

 Stable grade 3 hypoalbuminemia due to lupus nephritis, and not related to liver disease or malnutrition.

 Stable grade 3 gamma glutamyl transferase (GGT) elevation due to lupus hepatitis, and not related to alcoholic liver disease, uncontrolled diabetes, or viral hepatitis. If present, any abnormalities in alanine transaminase (ALT) and/or aspartate transaminase (AST) must be <=grade 2.

 Stable grade 3 hemoglobin reduction due to lupus.

 Stable grade 3 neutropenia or stable grade 3 white blood cell count.

 Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies.

['Placebo plus standard therapy', 'Belimumab 10 mg/kg plus standard therapy', 'Standard therapy']


WASH Benefits Kenya

Summary: The purpose of this study is to measure the independent and combined effects of interventions that improve sanitation, water quality, handwashing, and nutrition on child health and development in the first years of life.
Inclusion criteria: Study Population Description:

 The subject population will be young children and their mothers/guardians living in several contiguous districts of Western Province, in the rural areas outside the towns of Bungoma and Kakamega. Communities must meet the following criteria:

 Located in a rural area (defined as villages with <25% residents living in rental houses, <2 gas/petrol stations and <10 shops)

 Not enrolled in ongoing WASH or nutrition programs

 No chlorine dispensers at water sources installed by programs separate from the present study

 Majority (>80%) of households do not have access to piped water into the home

 At least six eligible pregnant women in the cluster at baseline.

 From enrolled communities, household compounds will be enrolled if they meet the following criteria.

 inclusion criteria:

 One or more women who self-identify as pregnant at the time of the baseline survey

 The woman plans to stay in the community for the next 12 months.

Exclusion criteria: :

 (1) The study excludes households who do not own their home to help mitigate attrition during follow-up.

['Water Quality', 'Sanitation', 'Handwashing', 'Nutrition']

Water Quality
Sanitation
Handwashing
Nutrition

['Malnutrition', 'Diarrhea', 'Child Development']


Lithium Versus Paroxetine in Major Depression

Summary: This study is being done to look at how well people respond to two different drug treatments for depression. Clinically, people can respond differently to different treatments for reasons which are not always clear. Some research shows that people with a family history of bipolar disorder or completed suicide may react differently to standard medications used to treat depression than those without a family history. The investigators need to know if these drugs are effective to use in patients with depression who have a family history of bipolar disorder or completed suicide.
Inclusion criteria: inclusion criteria:

 men or women

 age of 18 years or older

 meet criteria for major depressive episode, and have a family history of bipolar disorder or completed suicide

Exclusion criteria: :

 subjects not able to give informed consent

 pregnant or breast-feeding women

 current panic disorder, post traumatic stress disorder or psychosis

 subjects with a history of mania or hypomania

 subjects with active substance abuse or dependence in the last 6 months

 current depressive episode less than 4 weeks or greater than 12 months in duration

 adequate trial of lithium or paroxetine (lithium level ≥ 0.6mmols/l; paroxetine 20mgs ≥ 5 weeks) for this episode of depression

 concurrent use of other antidepressants or augmenting agents for the treatment of depression

 clinically significant medical illness, in particular renal impairment


Complement Factor H Haplotypes and Smoking in Age-related Macular Degeneration

Summary: Risk factors for Age-related Macular Degeneration (AMD) involves genetic variations in the alternative pathway of complement inhibitor factor H. The complement system is part of the innate and adaptive immune system. Smoking is the only environmental factor known to increase the risk of Age-related Macular Degeneration (AMD). Using serum samples of Age-related Macular Degeneration (AMD) patients and controls the investigators will test the hypothesis that smoking increases Age-related Macular Degeneration (AMD) by increasing complement activation; and that this is positively correlated with known disease variations in the complement factor H (CFH) gene.
Inclusion criteria: inclusion criteria:

 inclusion criteria for subjects will be a clear diagnosis of Age-related Macular Degeneration (AMD)

 inclusion criteria for controls will be less than five small (< 63 um) hard drusen

 At least a 20/40 view of the fundus

 The ability to provide a blood sample, and the absence of
Exclusion criteria:  listed


The Efficacy and Tolerance of Tacrolimus Sustained-release Capsules on Refractory Nephrotic Syndrome (RNS)

Summary: It is a pilot study to explore the efficacy and safety of Tacrolimus Sustained-release Capsules (ADVAGRAF) on 6-month induction therapy of Refractory Nephrotic Syndrome (RNS).
Inclusion criteria: inclusion criteria:

 Subjects of either sex, 14-60 years of age

 Diagnosis of Nephrotic syndrome with hypoalbuminemia (< 3.0g/dl) and heavy proteinuria (> 3.5g/24hr) and exclude secondary Nephrotic syndrome

 Refractory Nephrotic Syndrome

 Steroid resistant: failure to respond (either complete or partial remission) after a course of 8 weeks of 1.0 mg/kg/d prednisone or equal dose of steroid therapy

 Steroid dependent: recurrence of nephrotic proteinuria during tapering of prednisone at a dose > 10 mg/day or within the first 2 weeks after withdrawal of prednisone

 Frequently recurrence: initial remission with steroid induction therapy, but relapsed 2 or more in 6 months or 3 or more within 12 months

 Failure to respond (either complete or partial remission) even after CTX, MMF or CsA therapy combined with steroid

 eGFR ≥ 60 ml/min/1.73 m2

 Provision of written informed consent by subject or guardian

Exclusion criteria: :

 Systemic disease

 eGFR < 60ml/min/1.73m2

 Diagnosed DM

 Malignant tumors (except fully cured basal cell carcinoma)

 Familial nephritic syndrome

 History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease) within 3 month prior to enter this study

 Any Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C

 Known hypersensitivity or contraindication to tacrolimus, corticosteroids

 Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening

 Pregnancy, nursing or use of a non-reliable method of contraception

 Inability or unwillingness to provide written informed consent

 Usage of immunosuppression therapy (MMF, CTX, CysA, MTX ect) for more than 1 week within 1 month prior to first randomization or intravenous MP Pulse treatment

['Tacrolimus Sustained-release Capsules (ADVAGRAF)']


A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp

Summary: The purpose of this trial is to compare the rate of complete clearance of actinic keratosis (AK) using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone.
Inclusion criteria: inclusion criteria:

 Subjects must be competent to understand the nature of the trial and provide informed consent.

 Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on the face or scalp.

 Subject at least 18 years of age.

 Female subjects must be of either:

 Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,

 Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to study treatment, to rule out pregnancy.

 Female subjects of childbearing potential must be willing to use effective contraception.

Exclusion criteria: :

 Location of the selected treatment area:

 on any location other than the face or scalp

 within 5 cm of an incompletely healed wound

 within 10 cm of a suspected basal cell carcinoma (BCC) or SCC

 Prior treatment with PEP005 Gel on face or scalp.

 Selected treatment area lesions that have:

 atypical clinical appearance and/or

 recalcitrant disease

 History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication

 Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety and efficacy.

 Any abnormal vital signs measurements that are medically significant or would impact the safety of the subject or the interpretation of the trial results.

 Anticipated need for hospitalization or out-patient surgery during the first 15 days after the first trial medication application.

 Known sensitivity or allergy to any of the ingredients in PEP005 Gel

 Recent excessive exposure to ultraviolet light

 Current enrolment or participation in a clinical trial within 30 days of entry into this study

 Subjects previously randomised in the trial

 Female subjects who are breastfeeding

 Prohibited Therapies and/or Medications within 2 weeks prior to Visit 1

 Cosmetic or therapeutic procedures within 2 cm of the selected treatment area

 Use of acid-containing therapeutic products within 2 cm of the selected treatment area

 Use of topical medicated creams, ointments, lotions, gels, foams or sprays

 Prohibited Therapies and/or Medications: within 4 weeks prior to visit 1:

 Treatment with immunomodulators, cytotoxic drugs or inter-feron /interferon inducers

 Treatment with systemic medications that suppress the immune system

 Treatment/therapy with ultraviolet light A (UVA) or ultraviolet light B (UVB).

 Prohibited Therapies and/or Medications within 8 weeks prior to visit 1:

 Treatment with 5-FU, imiquimod, diclofenac sodium, or photodynamic therapy: within 2 cm of the selected treatment area.

 Prohibited Therapies and/or Medications within 6 months prior to visit 1

 Use of systemic retinoids or biologic / mono-clonal antibody therapies

['Cryotherapy', 'Vehicle', 'Ingenol metabute']


Parenteral Phenoxybenzamine During Congenital Heart Disease Surgery

Summary: Phenoxybenzamine, an irreversible alpha-adrenergic blocker, may prove beneficial to infants and children with congenital heart disease undergoing open cardiac repair, due to a theoretic benefits of a uniform and smooth reduction in systemic vascular resistance in the perioperative period. Vasodilation allows for low pressure, high flow systemic perfusion while on cardiopulmonary bypass. Support for the use of phenoxybenzamine in humans has been documented in several studies involving the perioperative management of both adults and children requiring cardiopulmonary bypass, and in management of patients with pheochromocytoma. 1-7 Phenoxybenzamine has been associated with more uniform body cooling and rewarming, and improved tissue perfusion during bypass.8 It is also known to increase cardiac output, stroke volume, and renal blood flow when given intravenously. 9 Specifically in pediatric open heart surgery, the combined use of phenoxybenzamine and dopamine provided a stable hemodynamic condition without a high total peripheral vascular resistance and stimulated postoperative diuresis. 9 Afterload reduction with parenteral phenoxybenzamine in neonates undergoing the Norwood procedure for hypoplastic left heart syndrome is associated with improved systemic oxygen delivery and stabilization of systemic vascular resistance.10 Furthermore, a strategy of reducing afterload with phenoxybenzamine and stabilizing the pulmonary to systemic flow ratio in this select population of patients has also been shown to improve operative survival. 11 We hypothesize that phenoxybenzamine will reduce afterload on the systemic ventricle in our selected patient population, thereby improving ventricular performance and decreasing the risks of pulmonary to systemic flow imbalance associated with current short-acting vasodilator therapy. We will plan to evaluate both physiologic variables as well as surgical outcomes in the selected study population.
Inclusion criteria: Patient selection will be determined by an assessment of the risk of systemic ventricular dysfunction following open cardiac repair in a population of infants undergoing stage I palliation (Norwood procedure) for the diagnosis of either hypoplastic left heart syndrome or similar left-sided obstructive lesions in the setting of single-ventricle physiology. Eligible neonates and infants include those aged 0 days to 6 months. These patients will be evaluated on an individual basis and the decision to give phenoxybenzamine would be determined by the attending surgeon, anesthesiologist, and cardiologist.
Exclusion criteria:

['Phenoxybenzamine', 'Standard surgical approach']

Phenoxybenzamine
Standard surgical approach


An Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Etonogestrel-releasing Medicated Intrauterine Systems (Study P06060)

Summary: This is a phase 2, randomized, active-controlled, parallel-group, multicenter, single-blind trial of three different doses of etonogestrel releasing medicated intrauterine systems (ENG-MIUS) in healthy parous women in need for contraception.~The primary trial objective is to explore safety and acceptability of three doses of an ENG-releasing medicated intrauterine system (ENG-MIUS) as compared to Multiload-cu 375®.
Inclusion criteria: inclusion criteria:

 Healthy female subjects in need for contraception will be selected to participate in the trial;

 Each subject must be >=18 to <=40 years of age at screening and in need for contraception;

 Each subject must have given birth to at least one child (gestational age >=28 weeks);

 Each subject must have a uterus with a measured length between 6.0 and 9.0 cm (extremes included) from external os to fundus uteri.

Exclusion criteria: :

 A subject must not be pregnant or suspected to be pregnant;

 A subject must not have had an ectopic pregnancy in the past or must not have a history or presence of predisposing factors for this condition such as salpingitis, endometritis or pelvic peritonitis;

 A subject must not have a history or presence of any malignancy;

 A subject must not have a history or presence of premalignant disease of the uterus or cervix, including endometrial hyperplasia, or (other) sex-steroid sensitive premalignancies;

 A subject must not have an active venous thromboembolic disorder (e.g. deep vein thrombosis, pulmonary embolism);

 A subject must not have a history or presence of severe hepatic disease with AST and/or ALT levels of >=3 times the upper normal limit;

 A subject must not have congenital or acquired malformations or distortions of the uterus or cervix;

 A subject must not have large or multiple uterine fibromyomata, or a smaller uterine fibromyoma which may interfere with the insertion of the MIUS/IUD according to the investigator;

 A subject must not have vaginal bleeding of undiagnosed etiology;

 A subject must not have dysmenorrhea interfering with daily activities or menorrhagia

['Etonogestrel-releasing IUS', 'Etonogestrel-releasing IUS', 'Etonogestrel-releasing IUS', 'Multiload-cu 375®']

Etonogestrel-releasing IUS
Etonogestrel-releasing IUS
Etonogestrel-releasing IUS
Multiload-cu 375®


Injection of Cyanoacrylate+Lipiodol vs Cyanoacrylate+Lauromacrogol in Gastric Varices

Summary: The purpose of this randomized study to compare effect of endoscopic injection of a mixture of cyanoacrylate and lipiodol versus cyanoacrylate and lauromacrogol in gastric varices.
Inclusion criteria: inclusion criteria:

 Patients presented to our hospital with acute gastric variceal bleeding, with or without liver cirrhosis.

 The age of the patients range from 18 to 80 years old.

Exclusion criteria: :

 Patients who have contraindications for cyanoacrylate, lipiodol or lauromacrogol therapy.

 Patients who have abnormal portosystemic shunt according to the imaging results.

 Patients who have no previous upper gastrointestinal bleeding history.

 Patients who have multiple endoscopic treatments for esophagogastric varices before.

['Gastric Varices', 'Portal Hypertension']


Revascularization Strategies for STEMI; The CMR Endpoint Study

Summary: Revascularization strategies for ST elevation myocardial infarction (STEMI) study (ASSIST-CMR) will compare the effects of two revascularization strategies [same sitting multivessel primary PCI (SS-PCI) and culprit vessel only primary PCI (IRA-PCI)] on myocardial infarct size (MIS) as determined by cardiac magnetic resonance (CMR) imaging in patients presenting with STEMI and multivessel disease (MVD).
Inclusion criteria: inclusion criteria:

 High risk ST elevation myocardial infarction evidenced by: ≥2 mm ST elevation in 2 anterior or lateral leads; or ≥2 mm ST elevation in 2 inferior coupled with ST depression in 2 contiguous anterior leads for a total ST deviation of ≥8 mm; or New left bundle branch block with at least 1 mm concordant ST elevation.

 Multivessel CAD as evidenced by ≥1 significant (≥70% by visual assessment or FFR<0.80 for 50-70% stenosis) stenosis in non-IRA.

 Successful IRA-PCI with <10% residual angiographic stenosis and TIMI III flow.

 Written informed consent.

Exclusion criteria: :

 Age ≤ 18 years.

 Prior coronary artery bypass graft (CABG) surgery.

 Administration of thrombolytic therapy.

 Non-IRA stenosis is a chronic total occlusion or located in left main artery.

 Hemodynamic instability evidenced by BP<90 mmHg, Killip class ≥2, need for inotropes/vasopressors.

 Known renal insufficiency (estimated GFR < 50ml/min).

 Contraindication to CMR.


Drug Use Investigation for Cervarix®

Summary: This post-marketing study was designed to assess safety and efficacy of Cervarix® vaccine in Japanese female subjects under conditions of actual use.
Inclusion criteria: inclusion criteria:

 Subject must be female

 Subject must be aged 10 and over

Exclusion criteria: :

 Subject with obvious fever

 Subject with obvious severe acute disease

 Subject with hypersensitivity to any component of Cervarix®

 Other than above, subject who is in inappropriate conditions for vaccination