Surveillance of Efficacy and Safety of Drug PRITOR in patieNts With Arterial Hypertension, Who do Not Tolerate ACE inhibitoR Treatment

Summary: Surveillance of efficacy and safety of drug PRITOR in patieNts with arterial hypertension, who do not tolerate ACE inhibitoR treatment
Inclusion criteria: inclusion criteria:

 Patients over 18 years of age

 Arterial hypertension (SBP < 160 mmHg and DBP < 100 mmHg)

 Patients, who do not tolerate ACE inhibitors (must be documented in the official ambulant documentation)

 inclusion criteria for the control arm (treated by ACEi):

 Patients over 18 years of age

 Arterial hypertension (SBP < 160 mmHg and DBP < 100 mmHg)

 Patients, who tolerate ACEi treatment

Exclusion criteria: :

 Cholestasis, severe hepatic insufficiency

 Allergy to telmisartan

 Gravidity or lactation


Screening and Risk Factors of Colon Neoplasia

Summary: The investigators propose a screening population-based study to systematically evaluate the accuracy and clinical relevance of sDNA testing as a potential alternative to colonoscopy screening. In addition, the investigators propose a genetic epidemiologic study of the relation between colon polyps, an established precursor of colon cancer, and two factors that may influence risk for colon cancer: candidate genes and diet.
Inclusion criteria: inclusion criteria:

 patients undergoing routine colonoscopy at University Hospitals, Cleveland Ohio

Exclusion criteria: :

 Unable to give written consents

 Unable to fill the questionnaires

 A history of polyps within the past 10 years (except hyperplastic polyps)

 Family history of Familial Adenomatous Polyposis (FAP) or Hereditary Non-Polyposis Colorectal Cancer (HNPCC)

 Personal history of inflammatory bowel disease

 Personal diagnosis of any cancer, with the exception of non-melanoma skin cancer

 Any major colon surgeries (e.g. resectioning)

['Stool DNA Test', 'biopsies of rectal and colon mucosa', 'Questionnaires']

Stool DNA Test
biopsies of rectal and colon mucosa
Questionnaires


A Cross-sectional Study for the Determination of the Prevalence of Non-valvular Atrial Fibrillation Among Patients Diagnosed With Hypertension

Summary: Arterial hypertension has been recognized as a major causal factor for atrial fibrillation (AF), the most common sustained cardiac arrhythmia. In light of its worldwide increasing prevalence and incidence and the accompanied increase in the risk of stroke, thromboembolic events and mortality, AF has emerged as a global healthcare problem.~Early diagnosis of AF, prior to the occurrence of complications is a recognized priority for the prevention of strokes. Once diagnosed, anticoagulant therapy is the cornerstone in the management of the risk of stroke in AF patients. The 2012 ESC Guidelines recommend the use of a risk factor-based approach to stroke risk stratification for AF patients.~This study aims towards gaining real-world data on the prevalence of non-valvular atrial fibrillation (NVAF) among hypertensives in Greece. The rate of ESC guideline-adherent antithrombotic therapy on the basis of stroke and bleeding risk assessments, and factors influencing treatment decision-making will be assessed as well in patients diagnosed with the arrhythmia.~Finally, potential differences in the NVAF prevalence in adequately and inadequately controlled hypertensives will be documented.
Inclusion criteria: inclusion criteria:

 Female and male outpatients aged 60 years and older

 Patients having being diagnosed with arterial hypertension

 For patients without a history of AF diagnosis, the decision to perform electrocardiography testing, either standard 12-lead ECG or ambulatory ECG, at the study visit has been made as per the investigator's routine practice

 Patients with available medical records

 Written signed and dated informed consent

Exclusion criteria:

 Presence of any condition/circumstance which in the opinion of the investigator would make the patient unfit to participate in the study or would compromise the quality of the study data (e.g., non-native speaker or patient who does not understand the local language unless reliable interpreter services are available; failure to cooperate due to major psychiatric disturbances, dementia, or substance use disorder)

 Patients currently participating in any investigational program with interventions outside of routine clinical practice or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) prior to enrollment


The Use of Mole Mapping Diagrams to Increase Skin Self Examination Accuracy

Summary: This study aims to improve Skin Self-Examination accuracy by a simple cost effective intervention requiring participants to complete a mole-mapping diagram.
Inclusion criteria: inclusion criteria:

 Male and female subjects above age 18 of any ethnicity will be enrolled in this study.

Exclusion criteria: :

 Subjects will be excluded from the study if they have significant skin disease which would not allow manipulation of their photographs consistent with the rest of the subjects.

 Since the study instructions are in English, Non-English speakers will be excluded.

 Those with co-morbidity sufficiently severe to prevent them from being able to perform a SSE will be excluded.

 In addition, those with cognitive impairment who are unable to give informed consent, or to understand the study instructions given to them, will be excluded.


Cases With Traumatic and Non Traumatic Brain Damage Treated in the Intensive Care

Summary: Cases of traumatic and nontraumatic brain damage have high rates of morbidity and mortality. In this study of cases being treated in the ICU for a diagnosis of brain damage, it was aimed to evaluate the relationship between mortality and the distribution of reason for and resulting type of brain damage and to determine other factors affecting mortality.
Inclusion criteria: inclusion criteria:

 Patients treated in the ICU with the diagnose of traumatic or nontraumatic brain damage, with a more than 24-hour stay.

Exclusion criteria: :

 Patients admitted less than 24 hour.

['type of the brain injury', 'type of the brain injury', 'type of the brain injury', 'type of the brain injury', 'type of the brain injury', 'type of the brain injury']

type of the brain injury
type of the brain injury
type of the brain injury
type of the brain injury
type of the brain injury
type of the brain injury

:

 Patients admitted less than 24 hour.


Examining Genetic Influence on Response to Beta-Blocker Medications in People With Type 2 Diabetes

Summary: Beta-blockers are medications used to treat cardiovascular disease (CVD) symptoms, including high blood pressure and chest pain. People with diabetes who receive beta-blockers may experience adverse health effects, but the exact cause of why this happens remains unknown. This study will examine the genetic factors that may influence how atenolol, a beta-blocker medication, affects fat breakdown, blood sugar levels, and heart function in people with type 2 diabetes.
Inclusion criteria: inclusion criteria:

 Type 2 diabetes

 Pre-Diabetes

Exclusion criteria: :

 Insulin therapy

 Treatment with any beta-blocker in the 30 days before study entry

 Asthma

 Chronic obstructive pulmonary disease (COPD)

 Greater than first degree heart block

 Heart rate less than 60 bpm

 Systolic blood pressure less than 90 mm Hg

 Raynaud's phenomenon

 Known history of angina, heart attack, heart failure, coronary revascularization, or automatic implantable cardioverter defibrillators

 Pregnant

 Creatinine clearance less than 35 ml/min

 Hematologic dysfunction (white blood cell [WBC] count less than 3000 or hematocrit less than 28%)

 Allergy to amide anesthetics


Affective Processing in Depression and Epilepsy

Summary: The goal of this study is to determine whether there are unique markers on neuroimaging that are associated with depression in epilepsy.
Inclusion criteria: For Control Group

 inclusion criteria:

 Healthy adults of 18 years of age or older.

Exclusion criteria: :

 Subject has no history of affective disorders

 Subject scores higher than 5 on Hamilton Depression Rating Scale

 Subject with prior primary diagnosis of any psychotic disorder, bipolar disorder, anxiety disorder, or any other serious medical or neurological disorder

 Subject is pregnant

 Subject is unable to undergo a MRI

 Epilepsy Only Group

 inclusion criteria:

 Subject is at least 18 years of age

 Subject has confirmed temporal lobe epilepsy (TLE)

['fMRI', 'Hamilton Depression Rating Scale', "Beck's Depressive Inventory", 'Interictal Dysphoric Disorder Inventory (IDDI)']


Human Papillomavirus (HPV) Vaccine (Cervarix TM) Efficacy, Immunogenicity & Safety Trial in Adult Japanese Women With GSK Biologicals HPV-16/18 Vaccine

Summary: Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. This study will evaluate the efficacy in prevention of persistent HPV-16 or HPV-18 cervical infection lasting at least 6 months, the immunogenicity and safety of GSK Biologicals HPV-16/18 vaccine (Cervarix TM ) over 24 months in Japanese adult women aged 20 - 25 years of age at study start. Approximately 1000 study subjects will either receive the HPV vaccine or a control vaccine (Hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule.~The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Inclusion criteria: inclusion criteria :

 Subjects who the investigator/co-investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.

 A Japanese female subject between, and including, 20 and 25 years of age at the time of the first vaccination.

 Written informed consent obtained from the subject prior to enrolment.

 Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study.

 Subjects must have a negative urine pregnancy test.

 Subjects must be of non-childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

 Subject must have an intact cervix

Exclusion criteria: :

 Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine/control within 30 days preceding the first dose of study vaccine/control, or planned use during the study period.

 Pregnant or breastfeeding women. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study.

 A women planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period, up to 2 months after the last vaccine dose

 previous administration of components of the investigational vaccine

 Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

 Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of vaccine. Routine vaccines may be allowed up to 8 days before the first dose of study vaccine.

 Previous vaccination against HPV.

 History of vaccination against hepatitis A or a known clinical history of hepatitis A disease

 Administration of immunoglobulin and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.

 Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination

 History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines

 Hypersensitivity to latex

 Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.

 Cancer or autoimmune disease under treatment.

 History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test.

 Heavy bleeding or heavy vaginal discharge such that a pelvic examination can not be performed

 Acute disease at the time of enrolment.

 Oral temperature >= 37.5°C / axillary temperature > 37.5°C.

 Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).

['HPV-16/18 vaccine (Cervarix™)', 'Aimmugen™']


Prognostic Value of Heart-type Fatty Acid-Binding Protein (h-FABP) in Acute Pulmonary Embolism

Summary: The patients presenting with acute pulmonary embolism and right ventricular dysfunction are at high risk for life-threatening events and must be identified in the emergency department for adequate care and hospital admission. Echocardiography can identify right ventricular dysfunction, but this test is not always available, and echocardiographic criteria of right ventricular dysfunction vary among published studies. The primary purpose of this protocol is to study the prognostic value of a cardiac biomarker, h-FABP (heart-type Fatty Acid-Binding Protein) , to identify in the emergency department the patients presenting with high risk pulmonary embolism. As secondary outcomes, H-FABP results will be compared to other cardiac biomarkers (BNP, troponin) and clinical score performances that have been previously studied to stratify the prognosis of patients with pulmonary embolism in the emergency department.
Inclusion criteria: inclusion criteria:

 patients with acute pulmonary embolism diagnosed in the emergency departement

Exclusion criteria: :

 patient under guardianship

 patient without social insurance

 pregnant women

 refusal to sign the consent

 myocardial infarction in the 10 days before pulmonary embolism


Single Pulmonary Nodule Investigation

Summary: A small proportion of patients with lung cancer present with a solitary pulmonary nodule (SPN). This is an important group of patients because if it is lung cancer, presentation as a SPN represents early disease, which following surgery has a high 5 year survival rate. However as not all SPNs are lung cancer it would be unethical to biopsy every case. Clinical guidelines recommend that SPNs should undergo an initial (FDG)-PET/CT scan, which may give more information about the SPN and may indicate if it is likely to be lung cancer. However in many cases it does not and current practice is to monitor the SPN with a series of CT scans over 2 years to look for changes or growth which may/ but not always indicate lung cancer. If no changes are observed over 2 years the SPN is considered not lung cancer. This is both expensive for the National Health Service (NHS) and worrying for the patient in terms of monitoring CT costs and delayed treatment due to length of time to diagnosis.~This study examines the diagnostic capacity of using a different CT scan. Dynamic Contrast Enhanced -CT(DCE-CT). DCE-CT and FDG-PET/CT scans give different information about the SPN and the investigators will look to see if information from either scan or combined information from both scans may be better in the diagnosis of early stage lung cancer. The investigators will also undertake a review of previous studies that have used these scans and use data from both the review and the trial to look at the cost effectiveness of using DCE-CT in the diagnosis of SPN.~The trial will recruit 375 people who have a SPN detected by a normal CT scan which requires a FDG-PET/CT scan. In addition they will receive a DCE-CT scan either on the same day or within three weeks of the FDG-PET/CT scan. This is the only extra procedure that will take place to normal NHS care, however we will collect clinical and outcome data over the next two years.~The study is coordinated by Southampton University clinical trials unit. Recruitment between January 2013 - April 2016, from up to 14 UK sites. Data analysis and conclusions are expected by the end of 2018.~The study is funded by the NIHR-HTA
Inclusion criteria: inclusion criteria:

 A soft tissue solitary dominant pulmonary nodule of ≥ 8mm and ≤30mm on axial plane

 Measured on lung window using conventional CT scan

 No other ancillary evidence strongly indicative of malignancy (e.g. distant metastases or unequivocal local invasion).

 If clinicians and reporting radiologists believe the patient is being treated as having a single pulmonary nodule and there are other small lesions <4mm that would normally be disregarded, the patient should be included in the trial.

 Nodules already under surveillance can be included provided they have a recent or scheduled FDG-PET/CT18 years of age or over at time of providing consent

 Able and willing to consent to study

Exclusion criteria: :

 Pregnancy

 History of malignancy within the past 2 years

 Confirmed aetiology of the nodule at the time of qualifying CT scan - As this is a diagnostic study, should the aetiology of the nodule be confirmed by investigation such as FDG-PET/CT or bronchoscopy prior to consent the patient remains eligible as the intention to include is made on the analysis of the qualifying CT scan.

 Biopsy of nodule prior to DCE-CT scan

 Contra-indication to potential radiotherapy or surgery

 Contra indication to scans (assessed by local procedures)


Autologous T-Cells Combined With Autologous OC-DC Vaccine in Ovarian Cancer

Summary: This is a phase-I clinical trial to determine the feasibility and safety of Cyclophosphamide/Fludarabine Lymphodepletion and an immunomodulatory combination of Interferon-alpha Bevacizumab and Aspirin followed by adoptive transfer of vaccine-primed ex vivo CD3/CD28-costimulated peripheral blood autologous T cells and vaccination with whole tumor vaccine administered intradermally in combination with Bevacizumab in patients with recurrent ovarian cancer fallopian tube or primary peritoneal cancer. (Funding Source - FDA OOPD)
Inclusion criteria: inclusion criteria:

 Subjects who have received at least one vaccine under protocol UPCC-19809 or UPCC-29810.

 ECOG performance status 0 or 1.

 Subject has sufficient vaccine (2 vaccine doses are sufficient)

 Must be at least 4 weeks post-operative

 Blood coagulation parameters: PT such that international normalized ratio (INR) is less than1.5 (or an in-range INR, usually between 2 and 3, if a subject is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thromboembolus) and a PTT less than1.2 times the upper limit of normal.

 Subject must be 18 years of age or older.

 Life expectancy of greater than 4 months.

 Normal organ and bone marrow function as defined by: Absolute neutrophil count greater than 1,000/microliter, Platelets greater than 100,000/microliter, Hematocrit greater than 30%, AST (SGOT)/ALT(SGPT) less than 2.5 X institutional upper limit of normal, Bilirubin less than 2.0 mg/dL unless secondary to bile duct blockage by tumor, and Creatinine less than 1.8 mg/dL

Exclusion criteria: :

 Subjects who require or are likely to require more than a two-week course of corticosteroids for intercurrent illness. Subjects must complete therapy prior to enrollment. Topical corticosteroids should be stopped at least 2 weeks prior to enrollment and systemic corticosteroids should be stopped at least 4 weeks prior to enrollment.

 Subjects with any acute infection that requires specific therapy. Acute therapy must have been completed at least seven days prior to study enrollment

 Subjects with any underlying conditions, which would contraindicate therapy with, study treatment (or allergies to reagents used in this study).

 Subjects with prior history or symptoms suggestive of partial or complete bowel obstruction.

 Subjects receiving class III antiarrythmic medications.

 Subjects receiving medications that might affect immune function. Additionally, H2 blockers are excluded, as are all antihistamines five days before and five days after each injection of study drug. NOTE: The following are exceptions: Proton pump Inhibitors (PPIs), NSAIDS including COX-2 inhibitors, acetaminophen.

 Subjects who are allergic to Aspirin are excluded

 Development of clinically significant co morbid disease that would contraindicate study therapy or confuse interpretation of study results.

 Subjects with a History of bowel obstruction, including sub-occlusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess.

 Subjects with evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction.

['OC-DC vaccine', 'Bevacizumab', 'cyclophosphamide 300 mg/m2/d for 3 days', 'fludarabine 30 mg/m2/d for 3 days', 'ex vivo CD3/CD28-costimulated vaccine-primed peripheral blood autologous T cells']

['Ovarian Carcinoma', 'Fallopian Tube Cancer', 'Primary Peritoneal Cancer']

Ovarian Carcinoma
Fallopian Tube Cancer
Primary Peritoneal Cancer


Effects of THW and rhTSH in Glomerular Filtration Rate During RIT

Summary: To observe the influence of thyroid hormone withdrawal and of recombinant human TSH during radioiodine therapy in renal function.
Inclusion criteria: inclusion criteria:

 Normal Renal Function

Exclusion criteria: :

 Abnormal Renal Function

 Renal metastasis

['Other Impaired Renal Function Disorder']


A Randomized Trial Comparing the Lokomat® With a Gait-related Physiotherapy Program in Children With Cerebral Palsy

Summary: The Lokomat is a robotic treadmill gait trainer that is used to help people who have neurologic conditions walk better. Early research with children with cerebral palsy (CP) shows that it may help to improve walking skills. The purpose of this two-group randomized study is to compare Lokomat training to regular physiotherapy (PT) as far as impact on walking abilities and related function. The primary (alternate) hypothesis is that children will improve more with Lokomat training in terms of gross motor skills and walking endurance.~The investigators are enrolling 40 ambulatory children who are ages 5 to 12 years, have CP and are in Gross Motor Function Classification System (GMFCS) Level II (n=20) or III (n=20). In this crossover randomized clinical trial (RCT), whether PT or Lokomat intervention is done first is decided by an independent randomization process that occurs after the first baseline assessment. In the Lokomat phase, children receive 8 to 10 weeks of twice weekly therapy for a maximum of 16 sessions. Each session is 35 minutes plus the time needed for set-up. The 35 minute PT program is also given twice weekly for 8 to 10 weeks for a maximum of 16 sessions, and focuses on a menu-based strength, co-ordination, fitness, walking and balance activities. There is a 6 week break between the Lokomat and PT interventions.~Each child has four study assessments during their ~6 months in the study. The first assessment is done before starting the Lokomat or physiotherapy phase. The second happens after the first intervention has finished. The child then has a 6-week break period. The third assessment is done at the end of this break, and the fourth occurs after the second intervention. The PT assessor who does these assessments will not be the same as the PT who gives the intervention. The assessor is blinded to the child's intervention phase and previous assessment results. The primary outcome measures are the Gross Motor Function Measure and 6 minute walk test. Secondary measures evaluate gait, functional abilities, participation, health related quality of life and individualized goals.~The randomized aspect of the study lets us look at outcome differences between children for Lokomat and PT within their first intervention phase (n=20/group). The cross-over phase evaluates within-child outcomes across the two phases. A qualitative component is concurrently underway to examine child/parent experiences and their views of Lokomat outcomes.
Inclusion criteria: inclusion criteria:

 age 5 to12 years inclusive

 assessed as GMFCS Levels II or III

 able to follow testing instructions, and participate in a minimum of 30 minutes of active PT

 able to reliably signal pain, fear and discomfort

 have passive range of motion (ROM) of hips and knees within minimum range requirement for Lokomat (hip and knee flexion contracture < 10 degrees, and knee valgus < 40 degrees)

 client of Child Development Program at Holland Bloorview

 able to commit to attendance of twice weekly for eight weeks (to support the primary efficacy analysis).

Exclusion criteria: :

 a fixed knee contracture > 10 degrees, knee valgus >40 degrees such that robotic leg orthosis will not be adaptable to lower limbs

 hip instability/subluxation > 45%

 orthopaedic surgery within the last 9 months (muscle) or 12 months (bone)

 Botulinum toxin-A (BTX-A) injections to lower limb in the last 4 months

 inability to discontinue BTX-A for period of 6 months (during trial) due to concerns about ROM or pain

 severe spasticity may be a contraindication

 any weightbearing restrictions

 seizure disorder that is not controlled by medication (if on medication, must not have had a seizure in the last 12 months)

 open skin lesions or vascular disorder of lower extremities

 not able to co-operate or be positioned adequately within the Lokomat as shown during the two Lokomat fitting/acclimatisation sessions

 not prepared or unable to discontinue a regular therapy intervention during the course of the trial

 involved in another intervention study


Neoadjuvant Chemoradiotherapy With or Without Gefitinib in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of the tumor. Combining chemotherapy and radiation therapy with gefitinib before surgery may shrink the tumor so that it can be removed during surgery.~PURPOSE: Phase I/II trial to compare the effectiveness of neoadjuvant chemoradiotherapy with or without gefitinib in treating patients who are undergoing surgery for stage III non-small cell lung cancer.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Histologically or cytologically confirmed non-small cell lung cancer

 Stage IIIA (T1-3, N2)

 Positive (pathological) ipsilateral mediastinal node

 Selective stage IIIB meeting all of the following criteria:

 No pleural/pericardial effusion or superior vena cava syndrome

 T4 due to invasion of carina, trachea, or mediastinal structures

 Mediastinal N3 nodes (without supraclavicular or cervical adenopathy)

 Proof of N2 or N3 status requires surgical staging of the mediastinum (mediastinoscopy, mediastinotomy, or exploration)

 Expression of epidermal growth factor receptor (at least 1+) by immunohistochemistry

 Measurable disease by contrast CT scan allowed

 No bronchoalveolar cell carcinoma

 No prior diagnosis of lung cancer

 PATIENT CHARACTERISTICS:

 Age

 19 and over

 Performance status

 ECOG 0-1 (0-2 if albumin is at least 0.85 times lower limit of normal and weight loss within 3 months before diagnosis is no greater than 10%)

 Life expectancy

 Not specified

 Hematopoietic

 Absolute neutrophil count at least 1,500/mm^3

 Platelet count at least 150,000/mm^3

 Hemoglobin at least 10 g/dL

 Hepatic

 Bilirubin normal

 AST and ALT no greater than 2.5 times upper limit of normal (ULN)

 Alkaline phosphatase no greater than 2 times ULN

 Alkaline phosphatase between 1.5-2 times ULN requires a negative bone scan for metastatic bone disease

 Renal

 Creatinine no greater than 1.4 mg/dL OR

 Creatinine clearance at least 60 mL/min

 Cardiac

 No myocardial infarction within the past 3 months

 No active angina

 No unstable heart rhythms

 No congestive heart failure

 Pulmonary

 Post-resection predicted FEV_1% greater than 35%

 Predicted FEV_1% is defined as FEV_1% times percent perfusion to uninvolved lung from quantitative lung V/Q scan report

 Other

 Not pregnant or nursing

 Negative pregnancy test

 Fertile patients must use effective contraception during and for at least 6 weeks after study treatment

 No other uncontrolled medical illness

 No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix

 No grade 2 or greater peripheral neuropathy

 No concurrent ocular inflammation or infection

 No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80

 No known severe hypersensitivity reaction to gefitinib or any of its excipients

 No prior severe allergic reaction to platinum-containing compounds or mannitol

 PRIOR CONCURRENT THERAPY:

 Biologic therapy

 No concurrent growth factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) during chemotherapy

 Chemotherapy

 No prior chemotherapy for lung cancer

 Endocrine therapy

 Not specified

 Radiotherapy

 No prior radiotherapy for lung cancer

 Surgery

 Recovered from prior major surgery

 No concurrent ophthalmic surgery

 Other

 More than 30 days since prior unapproved or investigational drugs

 No concurrent use of the following drugs:

 Phenytoin

 Carbamazepine

 Barbiturates

 Rifampin

 Phenobarbital

 Hypericum perforatum (St. John's Wort)

 Warfarin

 No concurrent retinoids
Exclusion criteria:

['cisplatin', 'docetaxel', 'gefitinib', 'gemcitabine hydrochloride', 'conventional surgery', 'neoadjuvant therapy', 'radiation therapy']

cisplatin
docetaxel
gefitinib
gemcitabine hydrochloride
conventional surgery
neoadjuvant therapy
radiation therapy


Epidemiologic Features of Kawasaki Disease in Shanghai From 2008 Through 2012

Summary: To investigate the epidemiological pictures of Kawasaki disease (KD) in Shanghai from 2008 through 2012, and illustrate the risk factors of coronary arterial lesions .
Inclusion criteria: inclusion criteria:

 The 5th revised edition of diagnostic criteria for KD, issued by the Japan Kawasaki Disease Research Committee at the 7th International Kawasaki Disease Symposium in 2002, was adopted. Cases were included in the study if the patients had at least five of the following six clinical manifestations or at least four signs together with coronary abnormalities documented by echocardiography or coronary angiography:

 fever persisting 5 days or longer (inclusive of those cases in whom the fever has subsided before the 5th day in response to therapy)

 bilateral conjunctival congestion

 changes of lips and oral cavity, such as reddening of lips, strawberry tongue, diffuse congestion of oral and pharyngeal mucosa

 polymorphous exanthema

 changes of peripheral extremities, such as reddening of palms and soles, indurative edema at initial stage, or membranous desquamation from fingertips at convalescent stage

 acute nonpurulent cervical lymphadenopathy. In addition, the cases of incomplete KD, diagnosed with referring to the guidelines for incomplete KD made by American Academy of Pediatrics (AAP) and American Heart Association (AHA) in 2004, were also included in this investigation

Exclusion criteria: :

 The cases were not in accordance with the recruited criteria


Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea

Summary: The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic bleeding profile in patients with dysmenorrhea and to investigate the long term safety
Inclusion criteria: inclusion criteria:

 Patients aged 20 years or older at obtaining informed consent

 Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before the final enrollment

 Patients having a total dysmenorrheal score of at least 3 points in twice of the latest menstruation before the final enrollment

Exclusion criteria: :

 Patients with ovarian chocolate cysts

 Patients with fibroid needed to be treated

 Patients with estrogen-dependent tumors and patients with cervical cancer or suspected cervical cancer

 Patients with undiagnosed abnormal vaginal bleeding

 Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease, or coronary artery disease or a history of those diseases

 Patients aged 35 years or older who smoke at least 15 cigarettes per day

 Patients with migraine accompanied by prodromata

 Patients with pulmonary hypertension or valvular heart disease

 Patients who are regularly taking nutritional products that contain St. John's Wort

 Patients who underwent surgical treatment for endometriosis within 2 months prior to screening

 Patients who may need to regularly use analgesics for therapeutic objectives other than relief from the pain of dysmenorrhea during this study (occasional use permitted)

['DRSP 3 mg/EE 20 µg (13 cycles)', 'DRSP 3 mg/EE 30 µg (6 cycles)']

DRSP 3 mg/EE 20 µg (13 cycles)
DRSP 3 mg/EE 30 µg (6 cycles)


Radiation Therapy Cisplatin With or Without Fluorouracil Patients With Stage III or Stage IV Head and Neck Cancer

Summary: RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cisplatin and fluorouracil may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without fluorouracil in treating patients with head and neck cancer.~PURPOSE: This randomized phase III trial is studying radiation therapy and cisplatin to compare how well they work with or without fluorouracil in treating patients with stage III or stage IV head and neck cancer.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx

 No histologic diagnosis other than squamous cell carcinoma

 A primary site must be identified

 Must have locoregionally confined stage III (excluding T1-2, N1) or stage IV disease

 No evidence of nodal disease below the clavicles or distant hematogenous metastases (M0)

 No stage IVC disease (stage IVB disease allowed)

 Deemed appropriate for definitive non-operative management with curative intent

 Resectable disease is not required

 No primary cancer of the nasopharynx, paranasal sinus, or salivary gland

 PATIENT CHARACTERISTICS:

 ECOG performance status 0-1

 WBC > 3,500/mm³

 Platelet count > 100,000/mm³

 Serum creatinine < 2.0 mg/dL

 Alkaline phosphatase < 2 times normal

 AST < 2 times normal

 Bilirubin ≤ 2.0 mg/dL

 Serum calcium normal

 Not pregnant or nursing

 Negative pregnancy test

 Fertile patients must use effective contraception

 No unstable or uncontrolled angina

 No clinically apparent jaundice

 No active infection

 No history of any other malignancy (except squamous cell or basal cell skin cancer or cervical carcinoma in situ), unless the patient has been continuously disease-free for at least 5 years

 Not a poor compliance risk

 Able to withstand the rigors of intensive treatment

 Available for and compliant with adequate long-term follow-up

 PRIOR CONCURRENT THERAPY:

 No prior definitive surgery or radiotherapy for this malignancy

 No prior chemotherapy, immunotherapy, or epidermal growth factor receptor inhibitors for any disease Patients who have had previous definitive surgery, or radiation therapy for this malignancy, and patients who have had any previous chemotherapy, immunotherapy, or EGF receptor inhibition for any disease are ineligible.

Exclusion criteria:  Patients with primary cancers of the nasopharynx, paranasal sinus or salivary gland are ineligible.

 Patients with unstable or uncontrolled angina, clinically apparent jaundice, or active infection are ineligible.

 Patients with a history of any other malignancy (except squamous or basal cell skin cancer or cervical carcinoma in-situ) are ineligible, unless the patient has been continuously disease-free for at least 5 years.

 Patients with any histologic diagnosis other than squamous cell carcinoma are ineligible.

 Patients who might be a poor-compliance risk are ineligible.

 Pregnant or breastfeeding women are ineligible. Women/men of reproductive potential must be willing to practice acceptable methods of birth control to prevent pregnancy.

['cisplatin', 'fluorouracil', 'radiation therapy']

cisplatin
fluorouracil
radiation therapy


Safety Trial of Magnetic Resonance (MR) Guided Focused Ultrasound Surgery (FUS) in Women With Uterine Fibroids Wishing to Pursue Pregnancy in the Future

Summary: The study objective is to develop data for the safety of pregnancies after thermal ablation of uterine fibroids by MR guided Focused Ultrasound using the Ex Ablate 2000 system.
Inclusion criteria: inclusion criteria:

 1. Subject with uterine fibroids, who desire pregnancy within 12 months and has the one of the following criteria: Women 20-40 age. Women age < 46 years old who plan to have egg donation. Women above 38 should test for normal ovarian function as judged by endocrinological evaluation.

 If the couple has failed to conceive for more that 1 year, the woman should test for normal ovarian function as judged by endocrinological evaluation, and the male must have adequate sperm test.

 Women undergoing fertility treatment or plan to have sperm donation.

 2. Use or non use of non-steroidal treatments for excessive vaginal bleeding such as antifibrinolytic agents (e.g. Tranexamic acid) or non-steroidal anti-inflammatory drugs (e.g. Mefanamic Acid) has been maintained for the three months prior to the planned date of the study procedure and the patient has agreed to maintain this use or non-use through the 6-month follow-up period.

 3. Clinically normal PAP smear within timing of National Guidelines in the country of the clinical site.

 4. Able and willing to give consent and able to attend all study visits

 5. Able to communicate sensations during the MRgFUS procedure

 6. Having uterine fibroids that are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone).

 7. Tumor(s) are clearly visible on non-contrast MRI.

 8. Largest fibroid 8 cm in diameter or 12 cm if receiving GnRH

Exclusion criteria: :

 1. Patient is pregnant as confirmed by pregnancy test at time of screening

 2. Uterine size >20 weeks as evaluated by US or MR.

 3. Patients who are considered high risk pregnancy due to uterine factors (e.g. abnormal uterus, uterine scars, cerclage) except fibroids.

 4. Patients with fibroid that is more than 50% sub-mucosal or with hysteroscopically resectable

 5. Patients with adenomyosis

 6. Patient is on dialysis

 7. Hematocrit is < 25

 8. Patient has hemolytic anemia

 9. Patient has unstable cardiac status including: § Unstable angina pectoris on medication§ Documented myocardial infarction within 6 months of protocol entry§ Congestive heart failure requiring medication (other than diuretic)§ Currently taking anti-arrhythmic drugs§ Severe hypertension (diastolic BP>100 on medication)§ Presence of cardiac pacemaker

 10. Patient has an ASA score of >2

 11. Patient has severe cerebrovascular disease (multiple CVA or CVA within 6 months)

 12. Patient is on anti-coagulation therapy or has an underlying bleeding disorder

 13. Evidence of uterine pathology other than leiomyoma

 14. Patient has an active pelvic infection or history of pelvic inflammatory disease

 15. Patient has an undiagnosed pelvic mass outside the uterus.

 16. Patient weight >110 kg

 17. Subject with extensive abdominal scarring in an area of the abdomen directly anterior to the treatment area.

 18. Subject with standard contraindications for MR imaging such as non-MRI compatable implanted metallic devices.

 19. Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist).

 20. Individuals who are not able or willing to tolerate the required prolonged stationary prone position during treatment (approximately 3 hours.)

 21. Patient with an intrauterine contraceptive device anywhere in the treatment beam path.

 22. Women who are breast feeding.

 23. Five or more fibroids, bigger then 3cm diameter, each

['Magnetic Resonance Guided Focused Ultrasound']


Study to Evaluate the Efficacy of the Human Papillomavirus Vaccine in Healthy Adult Women of 26 Years of Age and Older

Summary: This is a multicentre study in which women were planned to receive either the Human Papillomavirus Vaccine (HPV) vaccine or control. Under Protocol Amendment 3, study participation will last approximately 48 months and involves a total of eleven scheduled visits. Under Protocol Amendment 4, study participation will last up to 84 months and involves a maximum of seventeen scheduled visits.
Inclusion criteria: inclusion criteria:

 A woman who the investigator believes that she can and will comply with the requirements of the protocol.

 A women of at least 26 years of age at the time of the first vaccination.

 Written informed consent obtained from the subject prior to enrolment.

 Free of obvious health problems as established by medical history and clinical examination before entering into the study.

 Subject must have intact cervix.

 Subject must have a negative urine pregnancy test. This test is not applicable to women of non-childbearing potential.

 Subject must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or must be using an effective method of birth control for 30 days prior to the first vaccination and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion criteria: :

 Pregnant or breastfeeding (women must be at least three months post-pregnancy and not breastfeeding to enter the study).

 A women planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. up to two months after the last vaccine dose (Month 0 - 8).

 Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 84).

 Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

 Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e. days 0 - 29) the first dose of study vaccine. Planned administration/administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.

 Previous administration of components of the investigational vaccine

 Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.

 History of HPV infection/treatment or planned treatment to evaluate an abnormal cervical cytology (Pap smear) test, e.g. colposcopy.

 Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.

 History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine.

 Hypersensitivity to latex.

 Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.

 History of chronic condition(s) requiring treatment.

 Administration of immunoglobulins and/or any blood product within three months preceding the first dose of study vaccine, or planned administration during the study period. Enrolment will be deferred until the subject is outside of specified window.

 Acute disease at the time of enrolment.

 Heavy bleeding (menstruation or other) or heavy vaginal discharge in which a pelvic exam cannot be performed (and no cervical sample can be taken). Enrolment will be deferred until condition is resolved according to investigators medical judgement.

['Infections, Papillomavirus', 'Papillomavirus Vaccines']

Infections
Papillomavirus
Papillomavirus Vaccines


Study to Evaluate the Natural History of Head and Neck Cancer Precursors in Taiwan

Summary: Background:~- Cancer of the mouth and throat is one of the most common cancers in Taiwan. This cancer develops over several years, beginning as white or red patches in the mouth or throat that become growths. It can also cause a condition that leads to rigidity of the cheeks. The growths can be identified when a doctor looks into a person s mouth. It is currently not clear why some people with abnormal growths progress to cancer while others do not. Researchers want to better understand why some patients with early abnormal growths get late abnormal growths. They also want to understand why some people get abnormal growths again, even after they receive treatment.~Objectives:~- To understand why some people with precancerous lesions in their mouth develop cancer while others do not.~Eligibility:~- Adults 21 years and older, some with abnormal growths in the mouth, some without any, and some with head and neck cancer.~Design:~Participants will visit a hospital in Taiwan 2 times.~At the first visit, participants will answer questions about their health, lifestyle, and family medical history. A doctor will examine the participant s mouth and take a small piece of any growth they see. They will do this with a brush. They will also photograph the participant s mouth. Participants will also give blood and saliva samples, plus a small sample of a mouth rinse.~Participants who are diagnosed with a late abnormal growth that is not cancer will return for a second visit. They will answer the same questions and undergo the same procedures as at the first study.
Inclusion criteria: inclusion criteria

 We plan to recruit all patients (controls, precursors, and invasive cancers) at the aforementioned two hospitals. Doctors at these hospitals conduct routine visual and tactile examination as part of Taiwan s national oral cancer screening program. For this screening program, all individuals aged 21 years or older who chew betel-quid or smoke are screened through visual inspection for the presence of precursor lesions or cancer.

Exclusion criteria:

 Participants younger than 21 years and individuals with a history of head and neck cancer will be excluded from the study.


TORPEDO Study: A Study on Rapid Effect of Tocilizumab in Patients With Rheumatoid Arthritis With an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) or Anti-TNF

Summary: This study will assess the onset and maintenance of effect of tocilizumab on relief in patients with active moderate or severe rheumatoid arthritis who have had an inadequate response to DMARDs or anti-TNF. For the first, double-blind, part of the study patients will be randomized to receive an iv infusion of either 8mg/kg tocilizumab or placebo. After 4 weeks this will be followed by 11 months treatment with tocilizumab 8mg/kg iv infusion every 4 weeks. Methotrexate or DMARD therapy will be continued throughout study treatment. Target sample size is >100.
Inclusion criteria: inclusion criteria:

 adult patients >/= 18 years of age

 active moderate or severe rheumatoid arthritis of <10 years duration with inadequate response to methotrexate or anti-TNF

 on methotrexate treatment for at least 10 weeks, at least 8 weeks on stable dose

 patients receiving oral corticosteroids and/or NSAIDs should be at stable dose for 4 weeks

Exclusion criteria: :

 rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA

 functional class IV by ACR classification

 history of inflammatory joint disease other than RA

 previous treatment with cell-depleting therapies, abatacept or rituximab

 active current or history of recurrent infection, or any major episode of infection requiring hospitalization or treatment with iv antibiotics <4 weeks or oral antibiotics <2 weeks prior to screening

['tocilizumab [RoActemra/Actemra]', 'placebo', 'tocilizumab [RoActemra/Actemra]']

tocilizumab [RoActemra/Actemra]
placebo
tocilizumab [RoActemra/Actemra]


Periodontal Disease and Post-menopausal Osteoporosis

Summary: The aim of this study was to investigate the levels of RANKL and Osteoprotegerin, and their relationship in gingival crevicular fluid of post-menopausal women with osteoporosis/osteopenia and chronic periodontitis simultaneously and evaluate the effect that the use of bisphosphonates in periodontal disease.~Study hypothesis:~The osteoporosis / osteopenia in postmenopausal women patients with periodontal disease affect the ratio RANKL / OPG in gingival crevicular fluid samples favoring osteoclastogenesis processes
Inclusion criteria: inclusion criteria:

 Women between 45-70 years with Absorptiometry Dual Energy X-ray (DEXA).

 Control group: post-menopausal women with periodontal disease and normal osseous condition.

 Study group: post-menopausal womens with periodontal disease and osteoporosis/osteopenia with and without bisphosphonate treatment (risedronate or ibandronate 150 mg) for longer than 3 months before the study and another.

Exclusion criteria: :

 Patients with history of aggressive periodontitis and had received any periodontal treatment when they entered the study

 Patients with any systemic illness (except osteopenia/osteoporosis)

 Patients who received antibiotic or non-steroidal anti-inflammatory therapy in the 6 months prior to the study.

['Osteoporosis', 'Osteopenia', 'Periodontal Disease']

Osteoporosis
Osteopenia
Periodontal Disease


Corticosteroids in Community-acquired Pneumonia

Summary: The purpose of this study is to determine the efficacy of addition of corticosteroid therapy to antibiotics in children hospitalized with community-acquired pneumonia.~The hypothesis is that the use of corticosteroids decreases the length of stay in children hospitalized with community-acquired pneumonia.
Inclusion criteria: inclusion criteria:

 Children hospitalized for community-acquired pneumonia

 2-18 years old

Exclusion criteria: :

 Pulmonary chronic disease (including asthma)

 Immunodeficiency

 Diseases wich requires corticosteroids therapy (i.e. rheumatic diseases)

 Wheezing in current disease

 Previous hospitalization (14 days prior to admission)

 Pleural effusion on admission

 Malnutrition


Controlled Trial: 5-day Course of Rifampin Versus Doxycycline for the Treatment of Mild to Moderate Scrub Typhus

Summary: New antibiotics are required to have not only the antibacterial activity against doxycyline-resistant O. tsutsugamushi but also lower risk for resistance or any cross-resistance to others.~In this prospective, open-label, randomized trial, we enroll patients with mild-to-moderate scrub typhus. We compared the efficacy and safety of a 5-day rifampin therapy with those of a 5-day doxycycline therapy at Chosun University Hospital, or one of its two community-based affiliated hospitals which are all located in southwestern Korea between 2006 and 2009.
Inclusion criteria: inclusion criteria:

 inclusion criteria were:

 Adults aged 18 years or older

 A fever of higher than 37.5°C

 The concurrent presence of eschar or a maculopapular skin rash; and the clear presence of more than two symptoms such as headache, malaise, myalgia, coughing, nausea and abdominal discomfort.

 Patients were hospitalized at Chosun University Hospital in Kwangju, Korea or one of its two community-based affiliated hospitals which are all located in southwestern Korea between 2006 and 2009.

Exclusion criteria: :

 The


PREdicting Atrial Fibrillation or Flutter

Summary: The purpose of this study is to determine, through continuous monitoring with a cardiac monitoring device placed under the skin, the incidence of atrial fibrillation or flutter (AF). The cardiac monitor will be placed in patients without symptoms but at risk for AF. It is hoped that this information may assist health care professionals in treatment decisions related to the early identification of patients at high risk for AF.
Inclusion criteria: inclusion criteria:

 Patient meets the approved FDA indication to receive the ICM

 Patient is suspected, based on demographics, to be at high risk of having AF, as determined by the clinical investigator

 Patient has a CHA2DS2-VASc score ≥ 2 [Note: stroke/TIA criterion as part of the CHA2DS2-VASc score for this trial is limited to either an ischemic stroke or TIA, which occurred more than one year prior to enrollment.]

 Patient is 18 years of age or older

 Patient has a life expectancy of 18 months or more

Exclusion criteria: :

 Patient has a documented history of AF or atrial flutter

 Patient has a symptom complex consistent with an arrhythmia (where an ICM may have an alternate indication for use)

 Patient had an ischemic stroke or TIA within past year prior to enrollment

 Patient has a history of a hemorrhagic stroke

 Patient is currently implanted with a permanent pacemaker, insertable loop recorder, implantable defibrillator, cardiac resynchronization therapy device (pacemaker or defibrillator)

 NYHA Class IV Heart Failure patient

 Patient had heart surgery within previous 90 days prior to enrollment

 Patient had an MI within the previous 90 days prior to enrollment

 Patient is taking chronic immunosuppressant therapy

 Patient is taking an anti-arrhythmic drug

 Patient is contraindicated for long term anticoagulation medication

 Patient is taking a long-term anticoagulation medication

 Any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse, emotional / psychological diagnosis)

 Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from the principal investigator

 Patient has a creatinine clearance <30 ml/min or is on dialysis

 Active pregnancy

['Atrial Fibrillation', 'Atrial Flutter']


Analysis of Risk Factors for Death After Blunt Traumatic Rupture of the Thoracic Aorta

Summary: Aortic injuries after blunt thoracic trauma are compared to the great incidence of accidents relatively rare, but potentially serious leading to death at scene in most of the cases. The study was undertaken to delineate mortality and its risk factors on three different levels (pre-hospital, in-hospital and overall). Between 1990 and 2003, all consecutive patients and victims with traumatic aortic rupture were retrospectively analyzed by reviewing hospital and autopsy records.
Inclusion criteria: inclusion criteria:

 During the study period of 14 years (January 1990 to December 2003), all consecutive cases with traumatic rupture of the thoracic aorta being reported in the greater area of Zurich with about one million inhabitants were included in the present study

Exclusion criteria: :

 Non-traumatic aortic rupture

 Non-traumatic aortic dissection


A Morbidity-Mortality and Remodeling Study With Valsartan

Summary: The JIKEI HEART Study has been designed to investigate whether concomitant treatment with valsartan, an angiotensin II receptor blocker (ARB), in addition to conventional treatment, will improve the prognosis of 3000 Japanese patients with cardiovascular diseases.
Inclusion criteria: inclusion criteria:

 Clinical diagnosis of hypertension, ischemic heart disease and congestive heart failure

Exclusion criteria: :

 Pregnancy

 Severe renal damage

 Severe liver damage

 Acute myocardial infarction

['Hypertension', 'Ischemic Heart Disease', 'Congestive Heart Failure']

Hypertension
Ischemic Heart Disease
Congestive Heart Failure


Activin A and Inhibin A in Predicting Outcome of Pregnancies of Unknown Location After Assisted Reproductive Technology

Summary: The purpose of this study is to determine the predictive value of a single serum determination of activin A and inhibin A for the prognosis of ectopic pregnancy after in Vitro Fertilization (IVF) cycles, in both native and donated oocytes.
Inclusion criteria: inclusion criteria:

 Patients with pregnancy of unknown location (PUL) diagnosed 22 - 27 days after oocyte retrieval, at first ultrasound routine control (A pregnancy of unknown location (PUL) is a term used to classify a women with a positive pregnancy test and an empty uterus with no signs of an intrauterine or extrauterine pregnancy on a transvaginal ultrasound scan.)

 Patients with Intrauterine pregnancy : Viable intrauterine pregnancy (IUP) An intrauterine gestational sac containing a fetal pole with visible cardiac activity

 Patients with Ectopic pregnancy (Tubal ectopic pregnancy): An empty endometrial cavity with: (i) an inhomogeneous adnexal mass or (ii) an empty extrauterine gestational sac seen as hyperechoic ring or (iii) an extrauterine gestational sac with a yolk sac and/or fetal pole with or without cardiac activity
Exclusion criteria:


Effect of Nasal Steroids in Snoring Intensity

Summary: It is anecdotally well known that patients snore more when their nose is blocked. However, the therapeutic effect of improving nasal airway patency on snoring indices remains a point of conjecture. Indeed, Braver et al examined the effect of a nasal vasoconstrictor and failed to show any improvement in the number of snores after its application, although apnoea-hypopnoea index (AHI)seemed to decrease. Furthermore, Hoffstein et al documented that dilation of the anterior nares in patients without nasal pathology has a relatively weak effect on snoring, and routine use of nasal dilating appliances was not recommended for the treatment of snoring. In contrast to the aforementioned studies, intranasal corticosteroids have been shown to improve sleepiness and reduce AHI in patients with obstructive sleep apnea (OSA) implying that there might be an equivalent result for the use of nasal steroids on snoring indices.~Additionally, the present authors have demonstrated a strong correlation between apnoea-hypopnoea index and oral/oro-nasal breathing epochs in patients with OSA and normal nasal resistance and that nasal surgery is effective only in OSA patients who preoperatively have decreased nasal breathing epochs.~It is plausible thus to suggest that snoring severity, in equivalence to OSA severity, might be associated to oral/oro-nasal breathing epochs and that improving nasal patency by nasal steroids might also increase nasal breathing epochs and lead to decreased snoring indices in patients who had decreased nasal breathing before the administration of nasal steroids.~Patients will be randomized in two groups: the patients of the first group will undergo a one week therapy of nasal budesonide, then two weeks of washout period, and thereafter one week of nasal normal saline. The patients of the second group will undergo a one week therapy of nasal normal saline, then two weeks of washout period, and thereafter one week of nasal budesonide. Before and after each treatment regimen patients will undergo an assessment, which will consist of anterior rhinomanometry and polysomnography with concomitant measurement of snoring indices and breathing route pattern.~The investigators hypothesize that the application for one week of nasal budesonide has a beneficial effect on snoring indices in patients who present before the application decreased proportion of nasal breathing epochs and in whom nasal budesonide succeeded in increasing nasal breathing epochs.
Inclusion criteria: inclusion criteria:

 every night snoring;

 no medication known to influence nasal resistance (e.g., antihistamines, vasoconstrictors, topical or systemic steroids);

 no smoking for the last 6 months;

 no upper or lower respiratory tract disease (e.g., upper respiratory tract infection, rhinitis, sinusitis, chronic obstructive pulmonary disease), including a history of nasal allergy; and

 written informed consent from each patient.

Exclusion criteria: :

 duration of snoring less than 60 minutes during sleep study, and

 central apnoeas more than five percent of total apnoeas.

['nasal spray Budesonide', 'Nasal spray Normal Saline']

nasal spray Budesonide
Nasal spray Normal Saline


Safety, Tolerability and Efficacy Study of Doxycycline Foam for the Prevention of EGFRI Skin Toxicity in Cancer Patients

Summary: The purpose of this study is to evaluate the safety, tolerability and efficacy of FDX104 Antibiotic Foam in the prevention of EGFRI skin toxicity in cancer patients receiving Cetuximab or Panitumumab.
Inclusion criteria: inclusion criteria:

 Age 18 years and older

 Subjects with any cancer receiving Cetuximab or Panitumumab on a weekly or every 2 weeks basis.

 Scheduled to start Cetuximab or Panitumumab treatment;

 Males or non-pregnant, non-lactating females who are postmenopausal, naturally or surgically sterile, or with a negative subunit hCG pregnancy test immediately prior to study entry.

 Able to understand and provide signed informed consent.

 Ability to reliably apply topical FDX104 and vehicle twice a day to the appropriate part of the face

 Willingness to minimize sun exposure for 5 weeks from randomization

 ECOG performance status 0-2.

Exclusion criteria: :

 Prior allergic reaction or severe intolerance to Doxcycycline and/or other tetracyclines.

 Prior allergic reaction or severe intolerance to soy or coconut oil

 Cutaneous metastases on the face or might spread to the face.

 The presence of any active skin disease (e.g., eczema), tattoos or other problems at application site, (i.e., located on the face) that, in the investigator's opinion, could confound the evaluation of the rash or make topical application unacceptable

 Hair on the face (e.g beard) which would interfere with the application of the study drug or its evaluation.

 ANC <1,500/mm3 (or<1.5x109/L), or Platelet count < 100,000/mm3 (or <100x109/L)

 Abnormal renal functions: Serum creatinine >1.6 mg/dL or 142umol/L (SI units) or calculated estimated creatinine clearance <40 ml/min1.73 m2 based on Cockcroft and Gault formula.

 Abnormal hepatic functions: Serum Aspartate transaminase (AST) or alanine tansaminase (ALT) >5 institutional upper limit of normal (ULN). Or Total billirubin > 2 x institutional ULN or >5 x institutional ULN if documented liver metastasis.

 Any clinically significant safety laboratory results that, in the opinion of the Investigator, would place the subject at undue risk if the subject were to participate in the study

 Any clinically significant finding on the physical examination that, in the opinion of the Investigator, would place the subject at undue risk if the subject were to participate in the study

 Systemic lupus erythematosus

 Undergoing any current biological treatment for cancer other than the prescribed EGFRI

 Treatment with topical antibiotics, anti-acne medication and other topical treatments on the face within 14 days prior to treatment start. Use of topical corticosteroids within 2 weeks prior to baseline; only mild to moderate topical steroids are allowed outside the head and neck area. The area should not exceed 10% of the whole body surface area. In body folds, such as axillary and inguinal regions, only mild topical steroids are allowed in short term use (≤15 consecutive days).

 Treatment with systemic antibiotics 7 days prior to treatment start.

 Known or suspected pregnancy, or lactation or planned pregnancy (females)

 Previous enrolment in a clinical trial involving investigational drug or a medical device within 30 days before provision of written informed consent for the study

 Subjects who are mentally or physically unable to comply with all aspects of the study.

['Rash Due to Epidermal Growth Factor Receptor Inhibitors']


Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients

Summary: This study will assess the effect of a 24-week withdrawal followed by a 28-week reintroduction of belimumab 10 mg/kg plus standard of care medications in subjects with stable low systemic lupus erythematosus (SLE) disease activity. Rebound phenomenon will be assessed for subjects who have permanently withdrawn from further belimumab treatment.
Inclusion criteria: inclusion criteria:

 Received a minimun of 6 months therapy with with belimumab 10 mg/kg in their current SLE belimumab continuation study.

 Be 18 years of age at the Day 0 visit.

 Non-prenant, non-lactating females willing to comply with specific birth control requirements as set forth in the protocol.

 Able to provide written informed consent to participate.

 Subjects who wish to enroll in the control group and the group taking a 6 month belimumab treatment holiday will need a SELENA SLEDAI score of 3 or less after the minimum of 6 months belimumab therapy, as well as having C3 and C4 complement levels at or above the lower limit of the central laboratory reference range, and are on a stable SLE treatment regimen during the 30 day screening period prior to Day 0.

 Subjects who wish to enroll in the long-term discontinuation group have voluntarily withdrawn from their continuation studies.

Exclusion criteria: :

 Subjects who have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE, or experienced an adverse event (AE) in their belimumab continuation study that could, in the opinion of the principle investigator, put the subject at undue risk.

 Subjects who have developed any other medical diseases, laboratory abnormalities, or conditions that, in the opinion of the principle investigator, makes the subject unsuitable for the study.


IGF and Other Neurotrophic Factors in Patients With Dementia

Summary: The global prevalence of dementia is close to 36 million (2010). Furthermore the number is predicted to double in the next 20 years, primarily due to the demographic ageing. A perspective that will challenge the current healthcare systems and national economies.~Dementia is characterized by progressive deterioration in cognition, function and behavior that is sufficiently severe to compromise social and occupational functioning.~The pathogenesis of dementia remains elusive. Thus, there is a need to increase our understanding of the mechanisms leading to the most common forms of dementia. A better understanding of the disease may enable an earlier diagnosis and importantly, a causal treatment of Alzheimer as opposed to the merely symptomatic options available to day.~An experiment with rats and memory might already have taken the first step towards this. The experiment has demonstrated that administration of IGF-II to rats significantly enhances memory retention and prevents forgetting. Furthermore inhibitory avoidance learning leads to an increase in the hippocampal expression of IGF-II. Finally, yet importantly, injections of recombinant IGF-II into hippocampus after training or memory retrieval significantly enhance memory retention and prevent forgetting.~The spinal fluid and the serum will be analysed at the Medical Research Laboratory. The immunological concentrations of IGF-I and -II are measured by validated in-house analyses. Furthermore, Aarhus University Hospital has a unique technique, whereby it is possible to measure the bioactivity of IGF-I and -II in the cerebrospinal fluid. The concentrations of NGF, BDNF and sCD-163 in spinal fluid and serum will be analysed by already established techniques.~The purpose of this study is therefore to define the concentration and biological activity of IGF-I, IGF-II, BDNF, NGF and sCD-163 in the cerebrospinal fluid and serum in patients with Alzheimer's compared with controls.
Inclusion criteria: inclusion criteria:

 dementia, controls(lumbar puncture at our department)

Exclusion criteria: :

 <18år

 other CNS disease


Search of Biomarkers of Mineralocorticoid Receiver Activity : the Value of Neutrophil Gelatinase Associated Lipocalin (NGAL)in Serum or Urine in Human

Summary: Aldosterone and its target the mineralocorticoid receptor are implied in development of cardiovascular disease such as arterial high blood pressure or cardiac failure. Serum aldosterone level is insufficient to know if the mineralocorticoid receptor is activated or not. The aim of this study is to identify biomarkers of mineralocorticoid receptor activity. The first candidate biomarker is Neutrophil gelatinase-associated lipocalin (NGAL) or lipocalin which being measured in blood or in the urine. According to scientific knowledge's evolution, others biomarkers could be tested later thanks to the blood or urinary samples taken during study.
Inclusion criteria: For the group 1 and 2

 inclusion criteria:

 Men having an age ranging between 18 and 35 years

 Unhurt subject of any acute pathology for more than 7 days

 Consent signed by the subject

Exclusion criteria: :

 Subject presenting a known arterial high blood pressure (blood pressure > 140/90 mmHg) or any cardiovascular history

 Subject presenting a known renal insufficiency

 Subject presenting a known anaemia (Hb < 12g/dl)

 Subject presenting a known diabetes

 Subject presenting a cancer diagnosed less than 5 years previously or evolutionary cancer

 Subject presenting a chronic liver disease

 Subject presenting a connectivite: Rhumatoid polyarthritis....

 Crohns disease

 Current tuberculosis

 Any medicinal treatment

 Subject participating in another protocol or in exclusion's period for another protocol

 Absence of social insurance

 For group 3

 inclusion criteria:

 Men or women having an age ranging between 18 and 85 years

 Unhurt subject of any acute pathology for more than 7 days

 without any cardiovascular treatment

 Consent signed by the subject

['Urinary and blood lipococalin levels determination', 'Spironolactone']


A Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Summary: The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.
Inclusion criteria: inclusion criteria:

 The patient has a diagnosis of bipolar I disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) criteria and is currently experiencing a major depressive episode.

 Documentation that the patient has had at least 1 previous manic or mixed episode.

 The patient has had no more than 6 mood episodes in the last year.

 The patient's current major depressive episode must have started no less than 2 weeks and no more than 12 months prior to the screening visit. The current depressive episode must have begun after the patient's current mood stabilizer regime began.

 The patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium, valproic acid, lamotrigine, aripiprazole, olanzapine, risperidone, or ziprasidone (only if taken in combination with lithium or valproic acid).

 Written informed consent is obtained.

 The patient is a man or woman 18 through 65 years of age.

 The patient is in good health (except for diagnosis of bipolar I disorder) as judged by the investigator, on the basis of medical and psychiatric history, medical examination, electrocardiography (ECG), serum chemistry, hematology, and urinalysis.

 Women of childbearing potential (women who have not reached menopause, women who are less than 2 years postmenopausal, and women who are not surgically sterile) who are sexually active must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.

 The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol.

 The patient has permanent accommodations and means of being contacted by the study center.

 The patient understands that they may enroll in this clinical study only once and may not enroll in any other clinical study while participating in this trial.

Exclusion criteria: :

 The patient has any Axis I disorder apart from bipolar I disorder that was the primary focus of treatment within 6 months of the screening visit or during the screening period.

 The patient has psychotic symptoms or has had psychosis within 4 weeks of the screening visit or during the screening period.

 The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present.

 The patient has a history of an eating disorder or obsessive compulsive disorder (OCD) within 6 months of the screening visit or during the screening period.

 The patient has a history of alcohol or substance abuse or dependence (with the exception of nicotine dependence) within 3 months of the screening visit or during the screening period.

 The patient has a history of any cutaneous drug reaction or drug hypersensitivity reaction, a history of any clinically significant hypersensitivity reaction, or a history of multiple clinically relevant allergies.

 The patient has any clinically significant uncontrolled medical condition, treated or untreated.

 The patient has received modafinil or armodafinil within the past 5 years, or the patient has a known sensitivity to any ingredients in the study drug tablets.

 The patient has previously participated in a clinical study with armodafinil or has used any investigational product within 90 days of screening. The patient may not enroll in any other clinical study while participating in this study.

 The patient has ever been treated with vagus nerve stimulation (VNS) or deep brain stimulation (DBS), or has been treated with electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS) within 3 months of the screening visit.

 The patient is a pregnant or lactating woman.


Gulf Acute Heart Failure Registry

Summary: The Gulf Heart Association (GHA) sponsored Gulf acute heart failure registry (Gulf CARE)is a multinational , multicentre, prospective, observational, hospital-based registry of patients with acute heart failure(AHF) with 3 month and one year follow-up.~Study Hypothesis: Due to variations in age at presentation, risk factors for heart failure particularly high prevalence of rheumatic heart disease in certain Gulf countries, variable medical practices and heart failure management setup in the Gulf region, AHF patients in the Gulf states are expected to have different presentation and receive different management than patients in European countries resulting in different outcome. It is also hypothesized that there is considerable gap between heart failure management guidelines and clinical practices in the Gulf region.
Inclusion criteria: inclusion criteria:

 Clinical diagnosis of acute heart failure

 Admitted to the participating hospitals

Exclusion criteria: :

 Patients with acute heart failure who are discharged from the emergency room without admission.

 Patients transferred from non-registry hospital

 Failure to obtain informed consent


Measurements of Doppler Signals Noninvasively From the Lung in Congestive Heart Failure

Summary: The purpose of this study is to evaluate the lung Doppler signals in left HF patients with and without pulmonary congestion (i.e. decompensated left HF patients and compensated left HF patients respectively), in comparison to a control group of subjects without CHF (non-CHF controls), in order to determine the diagnostic value of this non-invasive method in CHF. If this method will prove to be of diagnostic value, it could potentially be used to diagnose and monitor CHF patients in both inpatient and outpatient settings.
Inclusion criteria: inclusion criteria:

 Age over 18 years

 Belongs to one of the following categories:

 A. Acute decompensated left HF: patients with acute pulmonary congestion or pulmonary edema diagnosed on the basis of all of the following criteria:

 Dyspnea at rest or with minimal activity

 Rales on auscultation

 Evidence of pulmonary congestion or edema on chest X-ray.

 BNP level >400 pg/ml

 B. Compensated left HF: patients with significant stable left HF (NYHA II-III) who are on optimal medical treatment for CHF, and are without clinical or laboratory evidence of pulmonary congestion. The following 3 criteria must be met:

 No dyspnea at rest

 No rales on auscultation

 BNP levels < 100 pg/ml

 C. Non-CHF controls: patients without CHF and without uncontrolled hypertension.

 3 Signed Informed Consent

Exclusion criteria: :

 - Decompensated left HF subgroup & Non CHF controls

 Pneumonia- currently or in the past 1 month prior to inclusion

 Non-cardiogenic pulmonary edema or lung injury (e.g. ARDS)

 Interstitial lung disease

 Severe kyphosis, scoliosis or chest wall deformity

 Pregnant women

 Compensated left HF subgroup

 Chronic obstructive pulmonary disease (COPD)

 Asthma

 Interstitial lung disease

 Any other obstructive or restrictive lung diseases

 Pneumonia- currently or in the past 3 months prior to inclusion

 Non-cardiogenic pulmonary edema or lung injury (e.g. ARDS)

 Current or past pulmonary embolism

 Large right sided pleural effusion

 Severe kyphosis, scoliosis or chest wall deformity

 Pregnant woman


Epidemiology and Pulmonary Response To Organic Dust Exposure

Summary: To characterize the nature of pulmonary responses to organic dust exposures in order to gain insight into patterns of respiratory disease in agricultural workers.
Inclusion criteria: No eligibility criteria
Exclusion criteria:

['Lung Diseases, Obstructive', 'Chronic Obstructive Pulmonary Disease']

Lung Diseases
Obstructive
Chronic Obstructive Pulmonary Disease


Peritoneal/ Serum Lactate Ratio in Relaparotomy

Summary: Laparotomy performed for both emergency of elective surgery may by complicated by intrabdominal collection, anastomotic leakage, infarction and others. This conditions are able to induce peritoneal inflammation. Inflamed peritoneum are able to produce excess of lactate that the investigators can measure by collecting fluid from peritoneal drainage.~Drainage were left in abdomen for monitoring intrabdominal condition until the passage of stool or flatus. Minimum drainage of serum is present daily also in uncomplicated post operative period.~Serum lactate relates with increased systemic anaerobic metabolism such as SIRS, sepsis and systemic hypoperfusion and it is easy to measure with a blood gas analysis.~The investigators hypothesized that the increases of peritoneal/ serum lactate ratio could be an earlier, sensible, non-invasive, and economical marker of post surgical complications. The decision whether and when to perform a relaparotomy in secondary peritonitis is largely subjective and based on professional experience. Actually no existing scoring system aids in this decision.~The aim of this study is to demonstrate that this ratio could be and useful tool for the surgeon in this decisional process.
Inclusion criteria: inclusion criteria:

 Post operative period of abdominal surgery (elective surgery of:colon-rectum, ileum, stomach and, pancreas)

 Post operative period after Urgent laparotomy for both traumatic and/or non traumatic acute abdomen

 Patients with signs of sepsis in the post operative period

 Patients with signs of systemic hypoperfusion in the post operative

Exclusion criteria: :

 Liver surgery

 Drainage of bile, blood and dejection from abdominal drainage

 Sepsis/ systemic hypoperfusion due to extraabdominal infection site


A Study to Assess the Levels of CAZ-AVI and Metronidazole in the Blood When Given Together and Separately

Summary: The purpose of the study is to assess whether there is any pharmacokinetic interactions between CAZ-AVI and metronidazole.
Inclusion criteria: inclusion criteria:

 Provision of signed and dated, written informed consent prior to any study-specific procedures.

 Healthy male and female subjects aged 18 to 50 years (inclusive) with suitable veins for cannulation or repeated venipuncture; female subjects must be post menopausal or surgically sterile.

 Male subjects should be willing to use barrier contraception ie, condoms, from the first day of the investigational product administration until 3 months after the last administration of the investigational product.

 Have a body mass index (BMI) between 19 and 30 kg/m2

 Be able to understand and willing to comply with study procedures, restrictions, and requirements, as judged by the Investigator

Exclusion criteria: :

 History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study

 History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs

 Known history of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious reaction to carbapenem or cephalosporin antibiotics or other beta-actam antibiotics or any other investigational product to be administered as part of the study

 Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks prior to the first administration of investigational product Any clinically significant abnormalities in physical examination, ECG, clinical chemistry, haematology, or urinalysis results, as judged by the Investigator

['CAZ-AVI', 'metronidazole', 'CAZ-AVI + metronidazole']

CAZ-AVI
metronidazole
CAZ-AVI + metronidazole


Study of the SafeSeal(TM) Hemostasis Patch Following Percutaneous Coronary Artery and Peripheral Vascular Interventions

Summary: We seek to determine if the use of the SafeSeal(TM) topical hemostasis patch is associated with reductions in time to hemostasis and time to ambulation compared to standard manual compression after arterial sheath removal following percutaneous coronary and peripheral intervention. We further seek to assess the safety of the SafeSeal patch compared to manual compression.
Inclusion criteria: inclusion criteria:

 Patient ≥ 18 years old

 Coronary or peripheral vascular intervention

 6 French arterial sheath used

 Overnight hospitalization following procedure

Exclusion criteria: :

 Hematoma or persistent bleeding around the vascular sheath

 Previous AV fistula or pseudoaneurysm in the ipsilateral femoral artery

 History of bleeding diathesis or coagulopathy

 Hemoglobin level < 9 g/dl

 Inability to ambulate at baseline

 Known allergy to any of the materials used in the SafeSeal

 Female patients known to be pregnant or lactating

 Evidence of ongoing systemic or cutaneous infection

 Uncontrolled blood pressure following PCI (systolic blood pressure > 180 or diastolic blood pressure >110)

 Current enrolment in another ongoing investigational drug/device trial.

['Coronary Artery Disease', 'Peripheral Vascular Disease']

Coronary Artery Disease
Peripheral Vascular Disease


Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder (PTSD)

Summary: This is a single-blind, placebo-controlled, parallel group study to evaluate the efficacy of BRL29060A (paroxetine hydrochloride hydrate, hereafter paroxetine) administered orally over the dose range of 20 mg to 50 mg once daily after supper for 12 weeks in Japanese patients with posttraumatic stress disorder (PTSD) as assessed by the change from baseline in CAPS-SX total score. Also the effect of paroxetine on regional cerebral blood flow (rCBF) induced by subthreshold emotional arousing (or symptom stimulating) tasks will be determined using functional magnetic resonance imaging (fMRI) for exploratory assessment of the correlation between the change in rCBF and the efficacy.~The sample size is 30 subjects. The study period consists of 4 weeks of run-in phase, 12 weeks of treatment phase, 0-3 weeks of taper phase and follow-up examination at 2 weeks after the last dose, for a total of 18-21 weeks.~Subjects will visit the clinic at the start of run-in phase, Week -2, the start of treatment phase, Weeks 2, 4, 6, 8 and 12 of treatment, and follow-up examination.
Inclusion criteria: inclusion criteria:

 Patients who are primarily diagnosed with PTSD (Posttraumatic Stress Disorder: 309.81) using DSM-IV-TR criteria. The CAPS-DX (Clinician-Administered PTSD Scale-DX) and M.I.N.I. (The Mini International Neuropsychiatric Interview, Japanese version 5.0.0. [2003]) will be used for diagnosis

 Pathologic condition: Patients who experienced a motor vehicle accident (MVA) with severe or potential severe physical injury more than 3 months ago but less than 12 months ago

 Patients aged 20 and <65 at the time of signing the Informed consent

 Male and female patients

 Inpatient/outpatient status: Both are permitted

 Patients who are able to give written informed consent in person (i.e., patients who are capable of giving written informed consent on their own)

 Patients whose combined score of the CAPS-SX standard B, C, and D is over 50

Exclusion criteria: :

 Patients primarily diagnosed with a DSM-IV-TR Axis I disorder other than PTSD (e.g. major depressive disorder, dysthymic disorder, specific phobia [simple phobia], obsessive-compulsive disorder, panic disorder, etc.) within 6 months of week -4 (start of baseline phase)

 Patients presenting with a current major depressive episode that preceded the diagnosis of PTSD

 Patients receiving disability payments due to PTSD or other psychiatric diseases

 Patients currently engaged in compensation litigation whereby personal gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders

 Patients who meet the DSM-IV-TR criteria for substance abuse or dependence (alcohol or drugs) within 6 months of Week -4 (start of baseline phase)

 Patients with history of a suicide attempt within 6 months before Week -4 (start of baseline phase), or have, in the opinion of the investigator, C. high risk of suicide according to the MINI at Week -4

 Patients who are pregnant, lactating or of childbearing potential and are likely to become pregnant

 Patients receiving electro-convulsive therapy (ECT) prior to Week -4 (start of baseline phase)

 Patients receiving another investigational product within 12 weeks before Week -4 (start of baseline phase)

 Patients with a history or complication of manic psychosis

 Patients with a history or complication of convulsive disorder (epilepsy, etc.)

 Patients with a diagnosis or complication of a cognitive disorder (MMSE <=24 points)

 Patients with a history and complication of serious cerebral organic disorder. (e.g. cerebrovascular disorder, meningitis, degenerative disease and other neurological disorders and seizures; however, bleeding in the upper arachnoid membrane should not be excluded)

 Patients unable or unwilling to undergo the fMRI procedure (e.g., cerebrovascular clipping surgery, pacemaker, any internal metals with magnetism, and claustrophobia)

 Patients with glaucoma

 Patients with a known tendency for bleeding or those with predisposing conditions

 Patients with a history of hypersensitivity to paroxetine

 Patients with serious physical symptoms (cardiac, hepatic and renal dysfunction, or hematopoietic dysfunction, etc.). For seriousness, Grade 3 of Criteria for seriousness of adverse reactions to drugs, etc. (Yakuan No.80) is used as an index

 Patients with a history or complication of cancer or malignant tumour

 Patients with chronic hepatitis type B and/or C which is positive of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody

 Others whom the investigator or sub-investigator considers ineligible for or unable to participate in the investigation

 Criteria at Week 0 (start of Treatment Phase):

 Subjects whose drug compliance rate for Drug 1 (Run-in Phase placebo) is <80% between Week -4 and Week 0;

 Subjects whose CAPS-SX total score of the standard B, C, and D at Week 0 varied by 25% or more compared with those at Week -2

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

Post-Traumatic Stress Disorder
Stress Disorders
Post-Traumatic


Thoracic Computed Tomography Scan for Diagnosis of Aspirated Foreign Bodies.

Summary: To access CT Scan as a diagnostic tool for foreign bodies aspiration.
Inclusion criteria: inclusion criteria:

 age between 6 months and 16 years

 suspicion of a foreign body aspiration

 health care assurance

 information of parents

Exclusion criteria: :

 emergency situation

 certainly of foreign body presence

 delay for CT Scan realization longer than 24 hours

 no speaking French parents

 parents refusal.

['Aspirated Foreign Body of Lower Respiratory Tract']


MetfoRmin and Its Effects on Left Ventricular Hypertrophy in Normotensive Patients With Coronary Artery Disease

Summary: Thickening of the heart muscle (left ventricle) known medically as Left Ventricular Hypertrophy (LVH) is very common in patients with heart disease. This increases risk of cerebrovascular/cardiovascular event.~LVH is asymptomatic and managed by the use of medication to control blood pressure, however LVH may be seen in normotensive patients where factors such as obesity and insulin resistance are present.~Insulin resistance is a condition where although the body produces insulin it is unable to utilize it effectively. Metformin, a drug used to treat diabetes, can reduce insulin resistance and cause weight loss, it may therefore improve LVH. This study will investigate the ability of metformin to reduce LVH in patients with heart disease, this may be a novel way forward in the risk reduction of cerebrovascular/cardiovascular events. Participants will be identified throughout NHS Tayside, those eligible will be randomly allocated to either metformin or a dummy medication (placebo) and will receive one year of treatment. At the beginning of the study, the thickness of the heart muscle will be measured by ultrasound scan and cardiac Magnetic Resonance Imaging (cMRI). We will also perform non-invasive tests to measure blood vessel function. These tests will be repeated after one year. At the end of the study, we will investigate the difference between placebo treatment and metformin treatment.~This study is funded by the British Heart Foundation.
Inclusion criteria: inclusion criteria:

 Aged 18 years or over

 Participant willing and able to give informed consent.

 Documented Ischaemic Heart Disease: either angio-graphically documented coronary artery disease or a previous history of myocardial infarction/angina.

 Screening echocardiography based diagnosis of LVH (LV mass indexed to height to the allometric power of 1.7; males > 81g/h1.7, females >60g/h1.7)

 Fasting insulin resistance index ≥ 2.7 AND/OR HbA1c >5.6 and less than 6.5 at screening

 Blood pressure < 140/85 mm Hg or 24hr BP <135/85 daytime average in screening

 Able (in the Investigators opinion) and willing to comply with all study requirements.

Exclusion criteria: :

 Cognitive impairment

 Type 1 or 2 Diabetes mellitus

 Chronic Heart Failure as evidenced by echocardiogram or documented diagnosis of CHF

 Left Ventricular Ejection Fraction <45% on screening echocardiography

 Contraindications to cardiac MRI (pacemakers, claustrophobia, metal implants, history of penetrative eye injury or exposure to metal fragments in eye requiring medical attention)

 Malignancy (receiving active treatment) or other life threatening disease, renal disease (CKD class 3B or worse)

 Pregnancy/lactating females

 Any other reason considered inappropriate by a study physician

 Participants who have participated in any other clinical trial within the previous 30 days.

['Left Ventricular Hypertrophy', 'Insulin Resistance', 'Coronary Artery Disease', 'PreDiabetes']

Left Ventricular Hypertrophy
Insulin Resistance
Coronary Artery Disease
PreDiabetes


Studying DNA in Tumor Tissue Samples From Patients With Localized or Metastatic Osteosarcoma

Summary: RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~PURPOSE: This research study is looking at DNA in tumor tissue samples from patients with localized or metastatic osteosarcoma.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Diagnosis of localized or metastatic osteosarcoma

 Banked snap-frozen tumor tissue samples and paired blood DNA samples available

 PATIENT CHARACTERISTICS:

 Not specified

 PRIOR CONCURRENT THERAPY:

 Not specified
Exclusion criteria:

['DNA analysis', 'RNA analysis', 'gene expression analysis', 'gene rearrangement analysis', 'mutation analysis', 'laboratory biomarker analysis']

DNA analysis
RNA analysis
gene expression analysis
gene rearrangement analysis
mutation analysis
laboratory biomarker analysis


Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD)

Summary: This is a pilot trial to see if one or two 40 treatment courses of low pressure hyperbaric oxygen therapy can improve cognition and brain imaging in subjects with either chronic mild-moderate traumatic brain injury (TBI), also known as post-concussion syndrome (PCS) or chronic PCS with post-traumatic stress disorder (PTSD) secondary to blast injury.
Inclusion criteria: inclusion criteria:

 Adults, 18-65 years old

 One or more mild-moderate TBI's characterized by loss of consciousness due to blast injury that is a minimum of one year old and occurred after 9/11/2001

 Absence of acute cardiac arrest or hemorrhagic shock at time of TBI.

 Absence of intracranial neurosurgery post-TBI

 Disability Rating Scale of 0-3

 Negative Michigan Alcohol Screening Test (MAST)

 Negative Drug Abuse Screening Test (DAST)

 Negative urine toxicology screen for drugs of abuse

 Negative pregnancy test in females

 Otherwise good health

 Less than 90% on the Percent Back to Normal Rating Scale

Exclusion criteria: :

 Pulmonary disease that precludes HBOT

 Unstable medical conditions that are contraindicated in HBOT

 Severe confinement anxiety

 Pregnancy

 Other pre-TBI neurological diagnoses

 Pre or post TBI history of substance abuse

 Pre or post TBI history of alcoholism.

 Participation in another experimental trial with active intervention.

 High probability of inability to complete the experimental protocol.

 Previous HBOT

 History of hospitalization for past TBI, stroke, nonfebrile seizures, or any seizure history other than seizure at the time of TBI

 Past or current history of mental retardation (baseline FSIQ < 71.

 Pre/post-TBI history of systemic illness with impact on CNS (P.I.'s decision)

['Low pressure hyperbaric oxygen therapy', 'Low pressure hyperbaric oxygen therapy']

Low pressure hyperbaric oxygen therapy
Low pressure hyperbaric oxygen therapy

['TBI (Traumatic Brain Injury)', 'Post Concussion Syndrome', 'Post Traumatic Stress Disorder', 'Chronic Post Traumatic Stress Disorder']

TBI (Traumatic Brain Injury)
Post Concussion Syndrome
Post Traumatic Stress Disorder
Chronic Post Traumatic Stress Disorder