Eliquis (VTE Treatment and Prevention of Recurrent VTE) rPMS

Summary: To assess the real-world safety/effectiveness of Eliquis in Korean venous thromboembolism (VTE) patients and patient characteristics that are associated with bleeding among patients taking Eliquis. To identify factors that might be associated with the safety and effectiveness profile in Korean VTE patients.
Inclusion criteria: inclusion criteria:

 Adult (≥19 years of age) patients who are initiating treatment with Eliquis for the treatment of VTE or prevention of recurrent VTE for the first time in accordance with the Korean package insert will be enrolled in the study

Exclusion criteria: :

 Patients with prior treatment with Eliquis before enrollment in this study

 Patients receiving Eliquis treatment for an indication not approved indication in Korea

 Patients meeting any of the following criteria will not be included in the study:

 i) Hypersensitivity to the active substance or to any of the excipients

 ii) Clinically significant active bleeding

 iii) Hepatic disease associated with coagulopathy and clinically relevant bleeding risk

 iv) Patients with increased bleeding risk due to such as following diseases:

 Recent gastrointestinal ulceration history

 Recent intracranial or intracerebral haemorrhage history

 Intraspinal or intracerebral vascular abnormalities

 Recent brain, spinal or ophthalmic surgery history

 Recent brain or spinal injury

 Known or suspected oesophageal varices

 Arteriovenous malformations

 Vascular aneurysms

 Patients with malignant neoplasms at high risk of bleeding

 Concomitant treatment with any other anticoagulant agent:

 i) Unfractionated heparin (UFH)

 ii) Low molecular weight heparins (enoxaparin, dalteparin, etc)

 iii) Heparin derivatives (fondaparinux, etc)

 iv) oral anticoagulants (warfarin, rivaroxaban, dabigatran, etc) except under the circumstances of switching therapy to or from apixaban or when UFH is given at doses necessary to maintain a patent central venous or arterial catheter

 Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption


Erythropoietin in the Prevention of Acute Mountain Sickness

Summary: Acute mountain sickness (AMS) is a syndrome of nonspecific symptoms and is therefore subjective. The Lake Louise Consensus Group defined acute mountain sickness as the presence of headache in an unacclimatized person who has recently arrived at an altitude above 2,500 m plus the presence of one or more of the following: gastrointestinal symptoms (anorexia, nausea, or vomiting), insomnia, dizziness, and lassitude or fatigue. An increase in RBC mass is a natural feature of altitude acclimatization. Hypoxia-induced erythropoietin (EPO) secretion begins hours after ascent and stimulates bone marrow production of red blood cells, but this takes weeks to effect an increase in red cell mass . Therefore, it is feasible that EPO therapy weeks before altitude exposure decrease high altitude illness.~In 1996, Young et al in U.S. Army Research Institute of Environmental Medicine (USARIEM) reported that autologous erythrocyte infusion did not ameliorate the decrement in maximal oxygen uptake at 4,300m altitude despite increasing arterial oxygen carrying capacity. On the basis of this report, USARIEM did not recommend use of recombinant EPO for altitude acclimatization.~However, increases in erythrocyte count, hematocrit and hemoglobin associated with EPO therapy have been shown to decrease fatigue and increase work capacity and exercise tolerance. In addition, improvement in CNS function and cognitive ability has been noted with EPO therapy. Subjective benefits include improvement in sleep habits, tolerance to cold; decreased dyspnea, anginal symptoms and tachycardia and improved appetite, all of which are symptoms associated with high altitude illness.~The investigators also reported improved muscle energy metabolism with EPO in dialysis patients, but not with RBC transfusion.~In this study, the investigators will conduct a randomised controlled trial to assess the effect of EPO administration on AMS at an altitude of 4,130 m.
Inclusion criteria: inclusion criteria:

 Healthy adults

Exclusion criteria: :

 History of serious illness

 Current smoker or Hemoglobin >15.5gm/dL

 Uncontrolled hypertension


The Incidence of Perioperative Deep Venous Thromboses of the Lower Extremities

Summary: The study's hypothesis is that there are some patients who come for surgery who have asymptomatic clots in their lower extremities upon their arrival to the hospital for their surgical admission. We will be performing duplex studies of the subjects' legs before their surgery to determine how often clots are present. We will also perform duplex scans of the legs after the subjects' surgeries to determine what factors (surgical, anesthetic, co-morbidities)are correlated with the development of DVTs.
Inclusion criteria: inclusion criteria:

 Age 18+ and consentable

Exclusion criteria: :

 Anticoagulation therapy or known DVT

:

 Anticoagulation therapy or known DVT


Transsphenoidal Extent of Resection Study

Summary: The purpose of this research study is to compare the extent of resection (EOR) in patients with nonfunctioning pituitary adenomas undergoing transsphenoidal surgery using a microsurgical technique to those patients who have undergone surgery with a fully endoscopic technique. Another goal is to compare surgical complications, endocrine outcomes, visual outcomes, length of surgery, length of hospital stay, and readmission rates between the two transsphenoidal surgery techniques. This is an observational data collection study with no experimental procedures or experimental medicines. Endonasal transsphenoidal removal of a pituitary tumor is a unique procedure and there is little information comparing the two surgical techniques.
Inclusion criteria: inclusion criteria:

 Patients with suspected nonfunctioning pituitary macroadenomas (≥ 1 cm) with planned transsphenoidal surgery

 Adults (age 18-80 years)

 Medically stable for surgery

 Reasonable expectation that patient will complete study and be available for follow-up assessments

Exclusion criteria: :

 Prisoners

 Pregnant women

 Patients with suspected functioning pituitary adenoma

 Unable to obtain MRI of the pituitary (e.g., pacemaker, anaphylaxis to gadolinium, low GFR)

 Pituitary apoplexy


Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)

Summary: The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with active SLE disease.
Inclusion criteria: Primary inclusion criteria

 Clinical diagnosis of SLE

 Active SLE disease

 On a stable SLE treatment regimen

 History of measurable autoantibodies

 Primary
Exclusion criteria:

 Received a non-FDA approved investigational agent within last 28 days

 Cyclosporin, intravenous immunoglobulin (IVIG) or plasmapheresis within last 90 days

 Active lupus nephritis requiring hemodialysis, cyclophosphamide (Cytoxan™), or high-dose prednisone (> 100 mg/day) within last 90 days

 Active central nervous system (CNS) lupus requiring therapeutic intervention within last 60 days

 History of renal transplant

 History of chronic infection that has been active within last 6 months, herpes zoster within last 90 days or any infection requiring hospitalization or intravenous medication within last 60 days

 History of hypogammaglobulinemia or immunoglobulin A (IgA) deficiency

 Human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C

['Placebo', 'Belimumab 1 mg/kg', 'Belimumab 4 mg/kg', 'Belimumab 10 mg/kg']

Placebo
Belimumab 1 mg/kg
Belimumab 4 mg/kg
Belimumab 10 mg/kg


The InChianti Follow-Up Study

Summary: Background:~- Older persons are often referred to physicians because of mobility difficulties that grow worse as they age. To better understand the reasons for mobility difficulties in older persons, researchers conducted a population-based study of individuals living in the Chianti geographic area of Tuscany, Italy. Researchers are now interested in conducting a follow-up study on the original participants to assess the effects of aging on their mobility.~Objectives:~- To conduct a follow-up study on the participants in the mobility study of older persons in the Greve in Chianti and Bagno a Ripoli areas near Florence, Italy.~Eligibility:~- Original participants in the InChianti Mobility Study.~Design:~The InChianti Follow-up Study will repeat most elements of the baseline evaluation from the original study. Participants will be seen on the 3-year anniversary of their baseline study assessment.~Participants will have a home interview with questions about their physical and mental health, family history, daily activities, and living conditions related to their continued mobility.~Participants will provide blood and urine samples, and will have tests of heart and motor nerve function and imaging studies of bones and the circulatory system.~Participants will also have a functional evaluation of their motor skills, including walking tests, range of motion tests, and grip strength.
Inclusion criteria: inclusion criteria:

 Age 65 years and older

 Must reside in Greve in Chianti or Bagno A Ripoli, Italy

 Subjects with modertative cognitive problems will be included as long as the consent can be read and signed by by a first-degree relative of the participant or, in absence of first-degree relative, another relative living with or close to the participant

Exclusion criteria: :

 Children


Safety and Immunogenicity of Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Using the Strain Composition 2007/2008

Summary: Annual trial for registration of sub-unit influenza vaccine produced in mammalian cell culture, using the strain composition 2007/2008, when administered to adult and elderly subjects
Inclusion criteria: inclusion criteria:

 Subjects eligible for enrollment into this study are male and female adults who were:

 ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry

 available for all the visits scheduled in the study and able to comply with all study requirements

 in good health as determined by:

 medical history

 physical examination

 clinical judgment of the investigator Written informed consent had to be obtained from all the subjects before enrollment in the study after the nature of the study had been explained.

Exclusion criteria: :

 Subjects were not to be enrolled into the study if at least one of the following criteria was fulfilled:

 Any serious chronic or acute disease such as:

 Cancer (leukemia, lymphomas, neoplasm), except for benign or localized skin cancer and non-metastatic prostate cancer not presently treated with chemotherapy

 Congestive heart failure

 Advanced arteriosclerotic disease

 Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy and/or acute exacerbation of a COPD within the last 14 days.

 Autoimmune disease (including rheumatoid arthritis), if under immunosuppressive therapy (see below)

 Insulin dependent diabetes mellitus

 Acute or progressive hepatic disease

 Acute or progressive renal disease

 Severe neurological or psychiatric disorder

 History of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine or chemically related substances

 Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting for example from:

 Receipt of immunosuppressive therapy (chronic therapy with immunosuppressive drugs, any parenteral or oral corticosteroid (substitution dose in case of absence of suprarenal function allowed) or cancer chemotherapy/radiotherapy) within the last 2 months and for the full length of the study,

 Receipt of immunostimulants,

 Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study,

 Suspected or known HIV infection or HIV-related disease.

 Known or suspected history of drug or alcohol abuse

 Bleeding diathesis or receive anticoagulants of the coumarin type

 Women who are pregnant or woman of childbearing potential unwilling to practice acceptable contraception for the duration of the study (21 days)

 Influenza immunization or laboratory confirmed influenza within the last 6 months and more than one influenza immunization within the past 12 months

 Immunization with any other vaccine and/or any investigational vaccine four weeks prior to study start

 Any significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days

 Fever (i.e. body temperature ≥ 38.0°C) within the past 3 days prior to study entry

 Simultaneous participation in another clinical study

 Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives.


Safety of 6-month Duration of Dual Antiplatelet Therapy After Acute Coronary Syndromes (SMART-DATE)

Summary: Objective : To test the safety of 6 month-duration of dual antiplatelet therapy (DAPT) compared to conventional 12-month-or-longer duration after second-generation drug-eluting stent (DES) implantation in patients with acute coronary syndrome (ACS).~Hypothesis : A 6-month duration of DAPT is non-inferior to a conventional 12-month-or longer duration of DAPT at preventing the occurrence of major adverse cardiac and cerebrovascular events (MACCE) at 18-month after second-generation DES implantation in patients with ACS.
Inclusion criteria: inclusion criteria:

 Subject must be ≥ 20 years.

 Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving percutaneous coronary intervention and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.

 Subject must have a culprit lesion in a native coronary artery with significant stenosis (>50% by visual estimate) eligible for stent implantation.

 Subject must have clinical diagnosis of ACS that includes unstable angina and MI. The specific definitions of ACS, as follows; 1) ST-segment elevation MI (STEMI) : elevation of ST-segment more than 0.1 mV in 2 or more contiguous electrocardiographic (ECG) leads or new left bundle-branch block with elevated biomarkers of myocardial necrosis 2) Non-ST-segment elevation MI (NSTEMI) : Elevated biomarkers of myocardial necrosis (troponin or CK-MB > upper reference limit) with one of the following; (a) Transient ST-segment elevation or depression, or T-wave changes consistent with myocardial ischemia, (b) Identification of a culprit lesion at coronary angiography 3) Unstable angina : An accelerating pattern or recurrent episodes of chest pain at rest or with minimal effort and new ST-segment depression of at least 0.05 mV, or T wave inversion of at least 0.3 mV in at least 2 leads. The ECG criteria for unstable angina were based on the TACTICS-TIMI 18 trial.

 Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥ 2.25 mm and ≤ 4.25 mm.

 Target lesion(s) must be amenable for percutaneous coronary intervention

Exclusion criteria: :

 The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Biolimus, Everolimus, Zotarolimus, and Contrast media (Patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled.)

 Patients with active pathologic bleeding

 Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.

 Systemic (intravenous) Biolimus, everolimus, zotarolimus use within 12 months.

 Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.

 History of bleeding diathesis, known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions

 Noncardiac comorbid conditions are present with life expectancy <1 year or that may result in protocol noncompliance (per site investigator's medical judgment).

 An elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first 12 months post enrollment.

 Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

['P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)']

P2Y12 inhibitor (clopidogrel
ticagrelor
prasugrel)


Pediatric Elective Intubation With and Without Muscle Relaxation Utilizing the Shikani Optical Stylet

Summary: The investigators' primary specific aims are to demonstrate that:~Pediatric patients with normal airways, undergoing elective surgical procedures, can be successfully intubated when deeply sedated, without the use of muscle relaxants using the Shikani Optical Stylet.~Shikani intubation of pediatric patients is equally effective in children that are deeply sedated or paralyzed as evidenced by a non-significant difference in:~Time to intubation (defined as no more than a 30 second time difference between the two groups);~Incidence of adverse events.
Inclusion criteria: inclusion criteria:

 6 months of age to 17 years of age (not yet 18)

 Male or female

 English or Spanish speaking

 Normal airway (Mallampati Classification )

 American Society of Anesthesiology Physical Status Classification I or II

 Elective surgical procedure expected to last at least 45 minutes in length

 Written informed consent/assent for participation given by the parent legal guardian and subject (if applicable)

Exclusion criteria: :

 < 6 months of age, > 17 years of age

 Difficult airway (Mallampati Classification)

 History of previous difficult intubation, suspected abnormal airway: *micrognathia

 facial trauma

 airway tumor

 epiglottitis

 retropharyngeal abscess

 foreign body, etc.

 Scheduled for non-elective, emergent OR procedure

 Parent, legal guardian, or subject is unavailable or unwilling to consent for study participation


Use of Local Anesthetic (0.25% Bupivacaine) for Pain Control in Pediatric Cardiac Catheterization

Summary: In the Cardiac Diagnostic and Interventional Unit (CDIU) at the Hospital for Sick Children (SickKids), minimally invasive procedures are performed to diagnose and treat a variety of congenital heart defects. Procedures are performed under general anesthetic and involve inserting a catheter through the skin and into the femoral vein or artery in the groin. In addition, the use of local anesthetic as a pain control regimen just prior to the removal of femoral artery or vein sheaths is used by some but not all cardiac interventionalists. Local anesthetic is infiltrated near the sheath insertion site, at the end of the procedure while the child is under general anesthetic, with the goal of decreasing pain at the insertion site and promoting comfort in the post-operative period. The use of local anesthetic depends on the choice of the individual practitioner and is not currently a routine practice for all patients.~The investigators proposed research seeks to investigate whether the use of subcutaneous bupivacaine reduces pain levels in the post-operative period in children having cardiac catheterization procedures.
Inclusion criteria: inclusion criteria:

 Ages 7-18 years

 Scheduled for cardiac catheterization through the femoral artery and/or vein under general anesthetic

 Ability to speak and understand English

 No apparent cognitive impairments

Exclusion criteria: :

 Known allergies to bupivacaine

 Impaired renal function

 Impaired hepatic function

['Standard of Care', 'Standard of Care plus bupivacaine']

Standard of Care
Standard of Care plus bupivacaine


The Chloroquine for Influenza Prevention Trial

Summary: A randomised controlled trial to determine the efficacy of chloroquine for the prevention of influenza
Inclusion criteria: inclusion criteria:

 Age 18 -65

 Have the ability to provide informed consent

 If a woman of child-bearing potential, willing to use contraception for the period of the trial

Exclusion criteria: :

 Acute influenza-like illness at screening

 History of psoriasis, porphyria cutanea tarda, epilepsy, myasthenia gravis, myopathy of any cause, cardiac arrhythmias, or serious hepatic or renal disease

 Pregnancy or breast feeding

 Current use of medication with known serious hepatotoxic effects

 Current use of medication with known serious interaction with CQ: amiodarone, anticonvulsants, ciclosporin, digoxin, mefloquine, moxifloxacin

 Current severe depression (as indicated by current use of antidepressant medication)

 Known serious retinal disease

 Current or recent (within the past 30 days) participation in any other clinical intervention trial.

 Known G6PD deficiency

 Vaccination for influenza (seasonal or H1N1 strain) within the 3 months prior to screening


Comparing the Pharmacodynamics and Pharmacokinetics of Explorative Formulation of Insulin Degludec With Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes

Summary: This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics (the effect of the investigated drug on the body) and pharmacokinetics (the exposure of the trial drug in the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, with insulin glargine in subjects with type 1 and type 2 diabetes.
Inclusion criteria: inclusion criteria:

 Glycosylated haemoglobin (HbA1c) below or equal to 10 procent based on central laboratory results

 Specific inclusion criteria for subject with type 1 diabetes:

 Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months prior to screening

 Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)

 Specific inclusion criteria for subject with type 2 diabetes:

 Diagnosed with type 2 diabetes mellitus for at least 12 months prior to screening

 Treated with insulin for the past 3 months prior to screening

 Body Mass Index (BMI) between 22.0 and 35.0 kg/ m^2 (both inclusive)

Exclusion criteria: :

 Subject with a history of significant multiple drug allergies or with a known allergy or suspected allergy to the trial product or any medicine chemically related to the trial product,as judged by the Investigator.

 Subject with a history of or presence of cancer

 Any condition that the Investigator and/or Sponsor feels would interfere with study

 Specific

['insulin degludec', 'insulin glargine']

['Diabetes', 'Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2']

Diabetes
Diabetes Mellitus
Type 1
Diabetes Mellitus
Type 2


Overnight Weight Loss and Sleep Structure

Summary: The objectives of the present study are:~to evaluate if overnight weight loss is dependent on sleep structure assessed by polysomnography;~to compare weight loss rate during sleep and awake rest;~to compare night weight loss profile of normal and obese volunteers.
Inclusion criteria: inclusion criteria:

 normal and obese volunteers

Exclusion criteria: :

 serious medical or neurological condition


Treatment of Dysphagia in Oculopharyngeal Muscular Dystrophy by Autologous Transplantation of Myoblasts

Summary: The OCULO-Pharyngeal Muscular Dystrophy (OPMD) is a late onset hereditary muscle disease which is characterised by the selective affection of the pharyngeal muscles resulting in swallowing disorders, and by a ptosis from the dysfunction of the levator palpebral superiors muscles. Swallowing disorders are determinant in the prognosis of the disease, and potentially life-threatening deglutition, due to aspiration and denutrition. Degenerative dystrophy of the pharyngeal muscles causes difficulties to prepulse the food bolus in the pharynx, and the decreased relaxation of the cricopharyngeal muscle induced by the disease leads to blockage of food in the upper esophageal sphincter. The most common treatment for the dysphagia in OPMD is a myotomy of the upper esophageal sphincter muscles. However, although this will relax the constriction of the upper esophageal sphincter muscles and improve transitory the swallowing, it will not prevent the progressive degradation of the pharyngeal muscles. This progressive loss of contractility will eventually result in aspiration and severe difficulty in swallowing, increasing risk of aspiration pneumonia and severe weight loss which are the most common causes of mortality in OPMD patients.~The protocol which we are proposing is a graft of autologous cell muscles (myoblasts) isolated from unaffected limb muscles into the pharyngeal muscles of patients diagnosed as suffering from OPMD. Our aim is to improve both swallowing and the contractile deficit generated by the dystrophic pharyngeal muscles. A myotomy of the upper esophageal sphincter will be carried out at the same time as the myoblast transplantation, since we have already validated the improvement resulting from this surgery. Advantages of this new therapy in OPMD is the autograft, without risks of rejection, and the graft of myoblasts into the dystrophic pharyngeal muscles, above the myotomy of the upper esophageal sphincter muscles.~This model of cellular therapy has been studied through a preclinical study performed in dogs, allowing to valid the procedure and its safety, as well as to study the survival myoblasts grafted in the pharyngeal muscles.~This protocol is proposed for OPMD patients; it is firstly a safety study of both autograft and surgical procedure. In addition, the autograft may improve the swallowing disorders and life-threatening complications induced by aspiration and weight loss, resulting in a potential individual benefit.
Inclusion criteria: inclusion criteria:

 Man or woman <18-75> years old

 Oculopharyngeal muscular dystrophy confirmed by genetic diagnosis (mutation of the GCG) on the chromosome 14)

 Oculopharyngeal muscular dystrophy with UES dysfunction

 salivary or alimentary stasis at fibroscopy of swallowing above the UES,

 decreased opening of the UES at videofluoroscopy of swallowing A decreased of the pharyngeal propulsion may be associated Written consent of the patient

Exclusion criteria: :

 History of myotomy of the UES in the context of the Oculopharyngeal muscular

 Dystrophy;

 HIV, hepatitis B or C tuberculosis);

 Lupus, rheumatoid polyarthritis, sarcoïdosis, collagenosis) ;

 Other neuromuscular diseases ;

 History of malignant tumor ;

 History of neck radiotherapy ;

 Renal failure (creatinine clearance <60ml/min)

 Liver failure ;

 Pregnancy ;

 Follow up less than 24 months:

 Patients who refuse to sign the consent;

 No social security.

['Autologous myoblasts transplantation and myotomy']


Resynchronization Therapy in Young Patients With and Without CHD

Summary: Pacemakers can be attached to one or more than one of the heart chambers. After watching pacemakers work over time, doctors have found that the pacemakers that stimulate only one chamber of the heart sometimes lead to problems later. These problems may be changes in the size and shape of the heart. The heart cannot work as well when some of these changes happen. We need to learn more about these changes and how to prevent them. There has not been an easy way to do this. A new treatment called Cardiac Resynchronization Therapy (CRT) is associated with biventricular pacing where two chambers of the heart are stimulated simultaneously. Tissue Doppler Imaging,Tissue Synchronization Imaging and 3 dimensional echocardiography are new forms of technology that look at the heart while it works. They are similar to a moving x-ray that can watch the heart muscles moving. The movement can be measured. Doctors will check for changes that happen over time. This has not been studied in children before because this kind of is new to this group of patients. This technology is noninvasive which means it can be done from the outside of the body and is painless.~The hearts of children grow fast. It is important to be able to know if the pacemaker or problems from dilated cardiomyopathy are causing any changes in the heart that might cause problems. We expect to be able to use information we learn from this study to improve how we use pacemakers in the future to avoid problems that can happen over time.
Inclusion criteria: inclusion criteria:

 Diagnosed with dilated cardiomyopathy

 normal heart anatomy or those with repaired congenital defects that have a 4 chambered heart

 referred for a Biventricular pacemaker implantation or upgrade with the diagnosis of dilated cardiomyopathy or for an echocardiogram due to the diagnosis of dilated cardiomyopathy without pacemaker

 signed informed consent

Exclusion criteria: :

 cannot travel back to Children's Healthcare of Atlanta for follow-up

 Patients with a transplanted heart

 no informed consent


Can Remote Ischaemic Preconditioning Reduce Contrast Induced Nephropathy in Patients Receiving Contrast for Computed Tomography?

Summary: Computated tomography (CT) is an invaluable medical resource for both physicians and surgeons. Contrast media are an aid to improve the diagnostic yield of CT. While an incredibly powerful means of imaging the human body, there are possible complications to the use of contrast including a hypersensitive response and contract induced nephropathy (CIN). The latter will typically occur 48-72 hours after administration.~One recent meta - analysis of serum creatinine levels following contrast enhanced CT found 6.4% of those undergoing this investigation developed CIN. Although typically transient, 1 % had a persisting reduced renal function, with a small minority needing renal replacement therapy (RRT). The development of CIN was influenced by co morbidities and by the amount of contrast given.~The mechanism of injury to the kidney is not definitively established, but is thought most likely due to hypoxia resulting from reduced blood flow, thereby giving rise to oxygen free radicals causing direct damage to the kidney and also direct tubular damage.~Remote conditioning ischaemia has been hypothesized to be nephroprotective, whereby induced transient ischaemia at another site could buffer the impact of the contrast medium's effects. This was first demonstrated during cardiac angiograms, with those patients whom received multiple balloon inflations in the coronary arteries were found to have a lower incidence of CIN than those with fewer balloon inflations. Thus it could be hypothesised that any ischaemia temporarily induced could be nephroprotective. This can be at a point of extremity, rather than involving central organs, such as the arm, with ischaemia induced by the use of a blood pressure cuff, inflated to above systolic blood pressure levels.~No studies have been found in the literature attempting to demonstrate this effect in relation to contrast CT studies. Consequently, a randomised control clinical trial of patients to assess the effectiveness of remote ischaemic preconditioning is proposed.~Study Hypothesis: That performing remote ischaemic preconditioning on those undergoing CTs involving IV contrast is nephroprotective.
Inclusion criteria: inclusion criteria:

 Hospital inpatients undergoing contrast enhanced abdomino-pelvic CT scanning.

Exclusion criteria: :

 Those with an allergy/hypersensitivity to the contrast solution

 Those with a Cr of above 150μmol/dL on admission, as is a contraindication to IV contrast.

 Patients who are not getting IV contrast

 Any patients with a history of renal transplantation

 Any patients with a history of previous acute kidney injury necessitating management by a nephrologist

 Patients taking either a sulphonlurea or nicorandil.

['Contrast Induced Nephropathy', 'Remote Ischaemic Preconditioning']

Contrast Induced Nephropathy
Remote Ischaemic Preconditioning


Brief Culturally Adapted Cognitive Behaviour Therapy for Depression

Summary: Cognitive behaviour therapy (CBT) has an effective evidence base in the west and is recommended by the national bodies in many countries in the West. Our group has adapted CBT for depression and psychosis in Pakistan for use with local clients. Initial evaluations have found that these therapies are effective. However, due to the financial restraints it would be useful if the investigators find that brief version of the CBT might be applicable and effective in non western cultures. Therefore in this study, the investigators will be testing effectiveness of brief version of culturally adapted CBT for depression in a randomized controlled trial (RCT) in Pakistan.
Inclusion criteria: inclusion criteria:

 All those who fulfil the diagnostic criteria of Depressive episode (F32) or Recurrent depressive disorder (F33 except 33.4 ) using ICD10 RDC (based on interviews using SCAN Urdu version),

 Are between the ages of 19-60,

 Score 8 or more on HADS, Depression Subscale, and

 Who live within traveling distance of the psychiatry department will be approached

Exclusion criteria: :

 Excessive use of alcohol or drugs (using ICD 10 RDC for alcohol or drug abuse or dependence)

 Significant cognitive impairment (for example learning disability or dementia) and

 Active psychosis


Postoperative Distress and Cosmetic Outcomes After Open Versus Robotic Thyroidectomy

Summary: Robotic assistance during thyroid surgery has been utilized clinically in Korea since late 2007. Robotic thyroidectomy has also been validated for surgical management of the thyroid gland. Compared with endoscopic thyroidectomy, the use of a robot in an endoscopic approach via the axilla provides a broader view of the thyroid bed, albeit from a lateral, as opposed to the conventional anterior, perspective. The wrist action of a surgical robot also provides a greater degree of movement than afforded by the use of simple endoscopic instruments, and tremor is eliminated.~Although several reports on operative outcomes of the robotic technique have appeared, no prospective trials comparing the clinical results of robotic with conventional open thyroidectomy have been described. We therefore designed a prospective trial comparing outcomes, including postoperative distress and patient satisfaction, between patients undergoing robotic and conventional open thyroidectomy.
Inclusion criteria: inclusion criteria:

 (a) a minimally invasive follicular thyroid carcinoma ≤4 cm in diameter, or

 (b) a papillary thyroid carcinoma ≤2 cm in diameter.

Exclusion criteria: :

 (a) previous neck operations;

 (b) age <21 or >65 years;

 (c) prior vocal fold paralysis or a history of voice or laryngeal disease requiring therapy;

 (d) a malignancy with definite extrathyroid invasion, multiple lateral neck node metastasis, perinodal infiltration at a metastatic lymph node, or distant metastasis; and/or

 (e) a lesion located in the thyroid dorsal area (especially adjacent to the tracheoesophageal groove) caused by possible injury to the trachea, esophagus, or recurrent laryngeal nerve (RLN)


Infection and Cardiovascular Disease

Summary: To investigate the role of chronic infection as a risk factor for vascular disease in a study of Native Americans. The primary focus is on the two most common agents Chlamydia pneumoniae and cytomegalovirus with a secondary emphasis on Helicobacter pylori.
Inclusion criteria: No eligibility criteria
Exclusion criteria:

['Cardiovascular Diseases', 'Coronary Disease', 'Cerebrovascular Accident', 'Heart Diseases', 'Myocardial Infarction', 'Infection', 'Chlamydia Infections', 'Cytomegalovirus Infections', 'Helicobacter Infections', 'Atherosclerosis']

Cardiovascular Diseases
Coronary Disease
Cerebrovascular Accident
Heart Diseases
Myocardial Infarction
Infection
Chlamydia Infections
Cytomegalovirus Infections
Helicobacter Infections
Atherosclerosis


Duration of Antibiotic Treatment of Erythema Migrans

Summary: The purpose of this study is to compare the efficacy of 15-day versus 10-day doxycycline treatment in patients with erythema migrans.
Inclusion criteria: inclusion criteria:

 solitary erythema migrans in patients > 15 years

Exclusion criteria: :

 a history of Lyme borreliosis in the past

 pregnancy or lactation

 immunocompromised status

 serious adverse event to doxycycline

 taking antibiotic with antiborrelial activity within 10 days

 multiple erythema migrans or extracutaneous manifestations of Lyme borreliosis


Field Trial of Hypotensive Versus Standard Resuscitation for Hemorrhagic Shock After Trauma

Summary: Primary Aim: To determine the feasibility and safety of hypotensive resuscitation for the early treatment of patients with traumatic shock compared to standard fluid resuscitation.~Primary Hypotheses: The null hypothesis regarding feasibility is that hypotensive resuscitation will result in the same volume of early crystalloid (normal saline) fluid administration compared to standard crystalloid resuscitation. The null hypothesis regarding safety is that hypotensive resuscitation will result in the same percent of patients surviving to 24 hours after 911 call received at dispatch compared to standard fluid resuscitation. Early resuscitation is defined as all fluid given until 2 hours after arrival in the Emergency Department or until hemorrhage control is achieved in the hospital, whichever occurs earlier.
Inclusion criteria: inclusion criteria: Included will be those with:

 Blunt or penetrating injury

 Age ≥15yrs or weight ≥50kg if age is unknown

 Prehospital SBP ≤ 90 mmHg

Exclusion criteria: : Excluded will be those with:

 Ground level falls

 Evidence of severe blunt or penetrating head injury with a Glasgow Coma Scale (GCS) ≤ 8

 Bilateral paralysis secondary to suspected spinal cord injury

 Fluid greater than 250ml was given prior to randomization

 Cardiopulmonary resuscitation (CPR) by Emergency Medicine Service (EMS) prior to randomization

 Known prisoners

 Known or suspected pregnancy

 Drowning or asphyxia due to hanging

 Burns over a Total Body Surface Area (TBSA) > 20%

 Time of call received at dispatch to study intervention > 4 hours

['0.9% Sodium Chloride 250 mL bolus', '0.9% Sodium Chloride 2000 mL bolus']

0.9% Sodium Chloride 250 mL bolus
0.9% Sodium Chloride 2000 mL bolus

['Blunt Trauma', 'Penetrating Wound', 'Hemorrhagic Shock']

Blunt Trauma
Penetrating Wound
Hemorrhagic Shock


Intrapartum Rapid GBS Testing in Patients Presenting With Threatened Preterm Labor

Summary: The purpose of this study is to evaluate the test characteristics of a rapid intrapartum real- time polymerase chain reaction (RT-PCR) compared to the intrapartum GBS culture as the standard in preterm patients presenting with threatened preterm labor or with obstetric indications for preterm delivery.
Inclusion criteria: inclusion criteria:

 Age ≥ 18 years

 Pregnant women presenting for unplanned obstetrical care at a participating clinical study site

 Gestational age between 21 6/7 and 36 6/7 weeks

 Subject has not participated in the study before

 Subject agrees to complete all aspects of the study and provide informed consent in accordance with applicable regulations

 Signs and/or symptoms suggestive of preterm labor, whereby the managing clinician suspects preterm labor

 Uterine contractions (with or without pain)

 Intermittent lower abdominal pain, dull backache, pelvic pressure

 Vaginal bleeding during the second and third trimester

 Menstrual-like intestinal cramping (with or without diarrhea)

 Change in vaginal discharge (amount, color, or consistency)

 Vague sense of discomfort characterized as not feeling right

 Change in cervical exam (cervical dilation, effacement, or consistency)

 Signs and symptoms necessitating preterm delivery (i.e abruption, preeclampsia, hemolysis elevated liver enzymes, low platelet (HELLP) syndrome, ruptured membranes, chorioamnionitis, fetal indications)

Exclusion criteria: :

 Exposure to antibiotics within 1 week prior to enrollment (15)

 Known GBS bacteriuria at the time of enrollment

 Prior history of neonatal GBS sepsis


Efficacy, Safety & Tolerability of Ciclesonide 200mcg Spray 4 Weeks Treatment for Intermittent & Persistent Rhinitis

Summary: To assess the efficacy, safety and tolerability of ciclesonide 200 mcg once daily, applied as a nasal spray for four weeks. The main outcome will be the improvement on global and individual typical and associated symptoms of intermittent or persistent rhinitis.
Inclusion criteria: inclusion criteria:

 All patients have to sign the informed consent or give verbal confirmation prior to their inclusion in the study.

 Outpatient (external) male or female over 18 years and under 50 years.

 Patients with active rhinitis (anterior or posterior rhinorrhea, sneezing, nasal congestion and itching) persistent (≥ 4 days a week for 4 consecutive weeks) or intermittent (< 4 days a week for ≤ 4 consecutive weeks).

 Patient with medical history of rhinitis 2 years prior to their participation in this study and whose nasal symptoms have been severe enough to require continuous or intermittent treatment (it requires a patient's symptoms need treatment at least for a 4 weeks period).

 Patient with the ability to understand the risks and benefits requirement while participating in the study and is able to accomplish the study treatment and with filling questionnaires and patient's diaries.

Exclusion criteria: :

 Patient with other nasal disease including: nasal polyps or nasal trauma recent.

 Patient with intranasal malformations (cysts and fistulas of the nose dorsum, prenasal space malformation, midline dystrophy, arrhinea, abnormalities of the tear ducts), or other conditions such as; recent nasal biopsy, drug rhinitis.

 Non-controlled asthma or who were under systemic corticosteroid treatment.

 Patient with Chronic Obstructive Pulmonary Disease.

 Medical history of respiratory infection or other disease including bronchitis, pneumonia, common cold, acute or chronic sinusitis, influenza, etc. within 30 days prior to its inclusion in the study.

 Patient receiving antibiotic therapy for any acute illness during the past 14 days.

 Patient vaccinated against pneumococcus, H1N1 & seasonal influenza (past 30 days).

 Patient required initiation or dose escalation immunotherapy. Immunotherapy is permitted if started 90 days ago and the patient received a stable dose during the last 30 days.

 Patient has participated in another research study within 30 days preceding this visit.

 Patient with medical history of hypersensitivity to steroids or any excipients of this class of drugs.

 Treatment with systemic corticosteroids for a chronic or intermittent disorder (e.g., dermatitis) during the last six months or can present a condition that requires them.

 Medical history of alcoholism and/or drug abuse in the last 2 years.

 Medical history or positive testing for HIV, hepatitis B or C.

 The patient uses any of drugs listed in the list on page 5 Table.

['Perennial Rhinitis', 'Seasonal Rhinitis']


Ondansetron Versus Metoclopramide in Treatment of Vomiting in Gastroenteritis

Summary: Is intravenous metoclopramid as effective as intravenous ondansetron in the treatment of persistent vomiting in patients with acute gastroenteritis.
Inclusion criteria: inclusion criteria:

 All acute gastroenteritis patient between 1-14 years presenting to PEC Al Saad with diarrhea, persistent vomiting , fail oral rehydration and admitted to the observation unit for intravenous hydration will be eligible for the study.

Exclusion criteria: :

 Previous abdominal surgery

 Suspicion of surgical abdominal

 Bile stained vomitus

 History of hepatic and renal illnesses

 In-born error of metabolism

 Children with shock or impending shock

 Sever dehydration.

 Previous hypersensitivity or abnormal reaction to metoclopramide or ondansetron

 Antiemetic treatment within 48 hours prior to presentation.

 Seizure disorder

['Treatment 1. Metoclopramide', 'Treatment 2 Ondansetron']

Treatment 1. Metoclopramide
Treatment 2 Ondansetron


Study of Neo-adjuvant RO7009789 Alone or Neo-adjuvant RO7009789 Plus Nab-Paclitaxel and Gemcitabine Followed by Adjuvant RO7009789 Plus Nab-Paclitaxel and Gemcitabine for Patients With Newly Diagnosed Resectable Pancreatic Carcinoma

Summary: The main purpose of this study is to learn if adding the investigational drug RO7009789 (anti-CD40) to nab-paclitaxel and gemcitabine both before surgery and after surgery is safe, feasible, and beneficial to patients with pancreatic cancer. This study also intends to look at blood and tissue samples to help doctors better understand the role of the immune system in fighting cancer.
Inclusion criteria: inclusion criteria:

 Histological documentation of primary adenocarcinoma of the pancreas

 Surgically eligible for tumor resection with curative intent

 Age ≥18 years

 ECOG PS 0 or 1

 Adequate bone marrow function (ANC ≥1,500; Hgb >9; Plt >100)

 Adequate renal function (Cr <1.5 ULN)

 Total bilirubin ≤1.5 x ULN; and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 x ULN (values post biliary stenting allowed for eligibility).

 Signed, written informed consent

Exclusion criteria: :

 Non ductal adenocarcinomas, neuroendocrine neoplasms, cystic tumors of the pancreas such as cystadenomas, cystadenocarcinomas and solid pseudopapillary neoplasms. In addition, adenocarcinomas arising from duodenum, distal bile duct, and ampulla will also be excluded.

 Patients with M1 disease or a history of M1 disease.

 Patients with any type of recurrent pancreatic adenocarcinoma

 Prior therapy such as chemotherapy or radiation therapy or anti-tumor experimental therapy for pancreatic cancer

 Previous treatment with any other compound that targets CD40

 Concurrent treatment with any anticancer agent outside of this protocol

 Prior allogeneic bone marrow transplant

 History of autoimmune disorder, including type 1 diabetes mellitus, pemphigus vulgaris, systemic mastocytosis, systemic lupus erythromatosis, dermatomyositis/polymyositis, rheumatoid arthritis, systemic sclerosis, Sjörgen's syndrome, vasculitis/arteritis, Behcet's syndrome, autoimmune thyroiditis, multiple sclerosis, or uveitis,. (Vitiligo is allowed)

 History (within the previous year) of stroke or transient ischemic attack, unstable angina, myocardial infarction, congestive heart failure

 History of deep venous thrombosis or migratory thrombophlebitis (Trousseau);

 Hereditary or acquired coagulopathies (e.g., hemophilia, von Willebrand disease, or cancer-associated DIC)

 Prior allergic reactions attributed to other monoclonal antibodies

 Concurrent or planned concurrent treatment with systemic high dose (immunosuppressive) corticosteroids or treatment with systemic corticosteroids within 4 weeks of baseline

 Treatment on another therapeutic clinical trial within 4 weeks of enrollment in this trial

 Concurrent or planned concurrent treatment with anticoagulants such as Coumadin or heparin, except to maintain patency of in-dwelling catheters

 Ongoing or active infection; treatment with systemic antibiotics or antifungals for ongoing or recurrent infection (topical use of antibiotics or antifungals is allowed)

 Pregnancy or breast-feeding - female patients must be surgically sterile, be post-menopausal, or must agree to use effective contraception during the period of therapy and for 90 days following the last dose of RO7009789. All female patients with reproductive potential must have a negative pregnancy test prior to enrollment. Women or men of reproductive potential may not participate unless they agree to use an effective contraceptive method. Female patients should not become pregnant while participating in this research study or for 90 days following therapy. Male patients should not father a child while in this research study or for 90 days following therapy.

 Other uncontrolled, concurrent illness that would preclude study participation; or, psychiatric illness or social challenges that would entail unreasonable risk or preclude informed consent or compliance with study procedures


Take HEED (Healthy Eating and Exercise Decisions)

Summary: This is a randomized intervention that examines the effect of culturally adapted weight loss program in African American (AA) females age 40-65. Evidence suggests that AA women are more successful with weight loss programs that are culturally tailored (Karanja, et al, 2002). Take HEED is a combination of 2 interventions, Therapeutic Lifestyle Changes Diet (TLC) from ATP-III and the CHANGE exercise program, which have shown success independently in previous clinical trials with AAs.
Inclusion criteria: inclusion criteria:

 BMI greater than 30

 African American

 40-46 years old

Exclusion criteria: :

 - bariatric surgery within the previous 5 years


Transcranial Magnetic Stimulation for Focal Hand Dystonia

Summary: Background:~The brain has natural electrical rhythms of brain activities. These rhythms may be different in people with movement disorders, such as dystonia (involuntary muscle movement, cramps, or tremors). Understanding these rhythms may provide more information about movement disorders.~Focal hand dystonia, also known as writer's cramp or musician's cramp, is a painful condition that affects the hand and arm muscles. Researchers want to use transcranial magnetic stimulation (TMS) to study brain rhythms in people with and without focal hand dystonia.~Objectives:~- To better understand brain rhythms involved in focal hand dystonia.~Eligibility:~Individuals between 18 and 70 years of age who are right-handed and have focal hand dystonia.~Healthy right-handed volunteers between 18 and 60 years of age.~Design:~Participants will be screened with a physical exam and medical history.~This study includes two tests: a pilot test and a main test. The pilot test will determine the frequency of TMS that will be used in the main test. Participants may be in one or both tests. Each test requires a single outpatient visit that will last up to 5 hours.~Participants will have a base test to see how their muscles respond to TMS. This will look at the electrical activity of the muscles. Participants will have a wire coil held on their scalp. A brief electrical current will pass through the coil. It creates a magnetic pulse that stimulates the brain. Researchers will test the TMS on the right and left sides of the head. This will help find the spot that activates the finger muscles, and see how much TMS is needed.~In the main test, participants will have repetitive TMS (rTMS). rTMS involves repeated magnetic pulses delivered in short bursts. There will be four pulses in each burst. Participants will have multiple bursts during the test. This test will look at how the muscles of the hand and fingers respond to brain stimulation.~Treatment for focal hand dystonia will not be provided as part of this study.
Inclusion criteria: inclusion criteria:

 Confirmed diagnosis of focal hand dystonia (patients only).

 Between age 18 and 70 years.

 Able to give informed consent

 Right handed

 Agrees to not drink caffeine or alcohol for 48 hours before study session.

 No open scalp wounds or scalp infections.

Exclusion criteria: :

 Has used illegal drugs within the past 6 months based on history, including but not limited to marijuana, cocaine, methamphetamine, etc. The intent is to exclude those with drug use that may affect study results. Participants who appear to be intoxicated at the time of testing will be rescheduled.

 Has more than 7 alcoholic drinks a week in the case of a woman and 14 alcoholic drinks a week in the case of a man.

 Abnormal findings on neurologic exam (other than dystonia in patient group)

 Has had a brain tumor, a stroke, traumatic brain injury, epilepsy or a history of seizures.

 Has major depression or any major mental disorders (axis I disorders)

 Has a neurologic disorder other than dystonia

 Has had a head injury where there was a loss of consciousness for more than a few seconds.

 Has a pacemaker, intracardiac lines, implanted pumps or stimulators, or has metal objects inside the eye or skull. Dental fillings and dental braces are allowed.

 Has known hearing loss.

 Pregnancy

 Taking any medication that acts as a central nervous system stimulant or that is known to lower seizure threshold, including, imipramine, amitriptyline, doxepine, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, (MDMA, ecstasy), phencyclidine (PCP, angel s dust), ketamine, gamma-hydroxybutyrate (GHB), alcohol, theophylline, mianserin, fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, reboxetine, venlafaxine, duloxetine, bupropion, mirtazapine, fluphenazine, pimozide, haloperidol, olanzapine, quetiapine, aripiprazole, ziprasidone, risperidone, chloroquine, mefloquine, imipenem, penicillin, ampicillin, cephalosporins, metronidazole, isoniazid, levofloxacin, cyclosporin, chlorambucil, vincristine, methotrexate, cytosine arabinoside, BCNU, lithium, anticholinergics, antihistamines, and sympathomimetics.

 Has excessive daytime sleepiness as indicated by a score of 10 or higher on the Epworth Sleepiness Scale.


Safety of Treatment of Uterine Fibroids With Asoprisnil

Summary: The objective of this study is to determine the long-term safety of asoprisnil in women with symptomatic uterine fibroids who completed the 6 month Study C02-037.
Inclusion criteria: inclusion criteria:

 Women that have completed 6 months of treatment in study C02-037 with no more than a 7-day interruption in their treatment

 Otherwise good health

 Premenopausal based on Estrogen and Follicle Stimulating Hormone levels

 Agrees to double-barrier method of contraception

 Adequate endometrial biopsy with no significant histological disorder

Exclusion criteria: :

 Any abnormal lab or procedure result(s) the study-doctor considers important

 History of a blood-clotting disorder

 Any prior surgical and/or invasive procedure(s) for uterine fibroids that resulted in either a cure or made the symptoms go away

 Significant gynecological disorder, such as endometrial polyp

['Fibroid Uterus', 'Leiomyoma', 'Menorrhagia', 'Metrorrhagia', 'Uterine Fibroids']

Fibroid Uterus
Leiomyoma
Menorrhagia
Metrorrhagia
Uterine Fibroids


Clinical and Genetic Analysis in Congenital Hypothyroidism Due to Thyroid Dysgenesis.

Summary: Congenital hypothyroidism (CH) is a rare disease that affects 1 in 3500 newborn. This condition is detected consistently since the late 1970s in France, which has led to early care and a significant improvement in prognosis and intellectual stature of these children. However neurodevelopmental disorders persist in 10-15% of cases. More associated diseases have been reported in approximately 10% of cases. These observations are in most cases poorly understood. The family nature of the CH is now well recognized and a dozen genes involved up to now. However, in the majority of cases (HC not due to a disorder of the organification of iodine), few mutations have been found in the reported number of patients (5-10%), suggesting the involvement of other genes. Some of the genes have been implicated in particular specific syndromic forms but many pathological associations remain unexplained. Also, a more complete genetic elucidation of CH would enable a better understanding of its etiology and thus its risk of familial recurrence (frequently asked questions by parents of children with CH) and secondly the presence of associated pathologies.~Main goal: to describe the population with CH (not due to a disorder of the organification of iodine) not only on clinical, biological and radiological (phenotypic analysis) but also on the genetic level to establish a genotype / phenotype correlation.
Inclusion criteria: inclusion criteria:

 - Patient: newborn (0-27 days) or infant (28 days 23 months), or child or adult with congenital hypothyroidism (that is to say with a TSH > 15 mU / ml at screening on filter paper and / or plasma TSH> 10 mU / ml) diagnosed in the first months of life, whatever their age, sex, weight and size.

 Subjects with blood levels of free thyroid hormones (FT3 and FT4) in the standards will be described as having subclinical hypothyroidism.

 If treatment with L-thyroxine could be stopped without relapse (that is to say, always with a TSH <5 mU / ml with different controls), hypothyroidism is said to be transient, whatever the age of discontinuation of treatment.

 No pre or neonatal goitre by palpation or ultrasound thyroid

 negative perchlorate test (ie decreased rate of iodine captation <10% at 2h injection of perchlorate) when the thyroid gland in place

 No self-immunity known to thyroid in children with and / or his mother (defined by a antithyroperoxidase antibodies and / or antithyroglobulin)

 Signature of free and informed consent by the patient or his legal representative

 Affiliation or enjoying a social security system

Exclusion criteria: :

 Presence of markers antithyroid autoimmunity in children and / or mother (antithyroperoxidase antibodies and / or antithyroglobulin)

 Pre or neonatal goiter on palpation or ultrasound thyroid

 Test positive perchlorate (ie salting rate of iodine> 10% at 2 injection perchlorate)

 Patients of foreign origin returned to their country will be excluded from the study.

['Clinical and radiologic exams and blood samples']


Multimodal Neurodiagnostic Imaging of Traumatic Brain Injury and Post-Traumatic Stress Disorder

Summary: The purpose of this study is to determine whether the brains of persons with and without traumatic brain injury differ in a meaningful way when advanced technology images of the brain are taken using three newer technologies that visualize the brain using a combination of external/internal magnetic fields and radioactive tracers (molecules that emit detectable particles). The hope is that the results of this study will validate tools (help prove that diagnostic tools actually detect disease) for the diagnosis and treatment of traumatic brain injuries (TBI).
Inclusion criteria: inclusion criteria:

 At least 18 years of age and non-active duty

 Either:

 Normal (no history of head injury) -OR-

 TBI (injury since Jan. 1, 2002)

Exclusion criteria: :

 Incapable of informed consent or absence of legally authorized representative.

 Incarcerated (or subject to court supervision).

 Known allergy to protocol contrast/imaging agent (or pregnant and unable to receive agent)

 MRI incompatible (i.e. implant, metal, > 300 lbs, severe claustrophobia)

['Traumatic Brain Injury', 'Post-Traumatic Stress Disorder']

Traumatic Brain Injury
Post-Traumatic Stress Disorder


Vancomycin Concentration in Cerebrospinal Fluid During Pneumococcal Meningitis

Summary: Adding vancomycin to the antibiotic regimen is recommended for the treatment of pneumococcal meningitis in adults. Use of dexamethasone as adjunct therapy has proved to reduce mortality and neurologic sequelae in adult patients with pneumococcal meningitis. However, use of dexamethasone may impair penetration of vancomycin in cerebrospinal fluid. In a purely observational manner, we thought to measure blood and CSF concentrations of vancomycin in adult patients with pneumococcal meningitis, treated with vancomycin, third-generation cephalosporin and dexamethasone.
Inclusion criteria: inclusion criteria:

 Adults (> 18 yr) with suspicion of pneumococcal meningitis requiring intensive care unit

Exclusion criteria: :

 Allergy to one of the antibiotics used in the study


Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic Disease

Summary: OBJECTIVES:~I. Determine the response rate and 1-year event-free survival in patients with severe autoimmune hematologic disease treated with high-dose cyclophosphamide.
Inclusion criteria: PROTOCOL ENTRY CRITERIA:

 --Disease Characteristics--

 Diagnosis of severe autoimmune hematologic disease Autoimmune hemolytic anemia OR Immune thrombocytopenia

 Failure of at least 2 standard treatment approaches (e.g., prednisone therapy, splenectomy, intravenous immunoglobulin, or other immunosuppressants)

 Inability to taper prednisone dose to less than 10 mg/day OR Autoimmune neutropenia including the following: Felty's syndrome OR Disorders of large granular lymphocytes with recurrent infections or absolute neutrophil count less than 200/mm3

 --Prior/Concurrent Therapy--

 See Disease Characteristics

 --Patient Characteristics--

 Age: Not specified

 Performance status: Not specified

 Hematopoietic: See Disease Characteristics

 Hepatic: Not specified

 Renal: Creatinine no greater than 2.5 mg/dL

 Cardiovascular: Ejection fraction at least 40%

 Pulmonary: FVC, FEV1, or DLCO at least 50% predicted

 Other:

 Not pregnant or nursing

 Negative pregnancy test

 Fertile patients must use effective contraception

 Not preterminal or moribund
Exclusion criteria:

['Anemia, Hemolytic, Autoimmune', 'Felty Syndrome', 'Purpura, Thrombocytopenic', 'Autoimmune Diseases']

Anemia
Hemolytic
Autoimmune
Felty Syndrome
Purpura
Thrombocytopenic
Autoimmune Diseases


Diagnosis of Neglected Tropical Diseases Among Patients With Persistent Digestive Disorders

Summary: NIDIAG is an international collaboration on integrated diagnosis-treatment platforms, funded by the European Commission (EC). NIDIAG aims to develop an improved, patient-centred system for delivering primary health care in resource-constrained settings. NIDIAG will investigate three clinical syndromes, namely (i) persistent digestive disorders, (ii) persistent fever and (iii) neurological disorders, due to neglected tropical diseases (NTDs). The current study focuses on persistent digestive disorders, which are defined as diarrhoea or abdominal pain that last for at least 2 weeks.~While acute diarrhoea has been studied globally, few research activities have focused on the epidemiology, diagnosis and treatment of long-lasting diarrhoeal episodes (2 weeks and longer) in the tropics. The spectrum of possibly involved pathogens includes more than 30 bacterial, parasitic and viral infectious agents. This lack of data may be explained by the fact that people suffering from NTDs might only seek care at a late stage of the disease. Furthermore, health systems in affected regions are often weak and their primary health-care centres are often under-staffed and lack essential diagnostic equipment.~The hypothesis of this study is that development of an evidence-based syndromic approach can lead to better diagnosis and management of NTDs in patients with persistent digestive disorders. The study will be carried out in two West African countries (Côte d'Ivoire and Mali) and in two Asian countries (Indonesia and Nepal). The study will follow a case-control design and patients and controls will be prospectively enrolled. In order to address the knowledge gaps, three specific objectives will be pursued. First, the contribution of NTDs to the 'persistent digestive disorders syndrome' will be assessed. Second, the value of clinical features and rapid diagnostic tests (RDTs) for the diagnosis of target NTDs that give rise to persistent digestive disorders will be determined. Third, the clinical response to standard empiric and targeted treatment of several NTDs in patients with persistent digestive disorders will be evaluated. These objectives will provide a long-term benefit for the communities by improving the clinical decision-making process for the target NTDs and thus, better diagnostic work-up and patient management can be achieved in the study countries and other similar resource-constrained countries
Inclusion criteria: inclusion criteria:

 Individuals aged ≥1 year presenting with persistent diarrhoea (≥3 loose stools per days for ≥2 weeks; symptomatic group) and/or children (aged 1-18 years) with persistent abdominal pain (localized or diffuse abdominal pain lasting for ≥2 weeks, with possible intermittence/recurrence).

 Individuals with written informed consent provided.

Exclusion criteria: :

 Individuals in need of immediate intensive or surgical care.

 Individuals who are unable or unwilling to give written informed consent.

 Individuals who do not meet the inclusion criteria for being a case or control (e.g. people with acute diarrhoea).

 Individuals with clinical jaundice (assessed by direct observation of the conjunctivae).

 Individuals who are unable, in the study physician's opinion, to comply with the study requirements.

 Individuals who are already participating in other ongoing diagnostic studies and/or clinical trials.

['Stool culturing for pathogenic bacteria', 'Kato-Katz technique', 'Baermann technique', 'Mini-FLOTAC', 'Crypto/Giardia Duo Strip', 'Formalin-ether concentration technique', 'CCA RDT', 'Koga agar plate culture', 'Kinyoun staining', 'Multiplex PCR', 'Metagenomics analysis']

Stool culturing for pathogenic bacteria
Kato-Katz technique
Baermann technique
Mini-FLOTAC
Crypto/Giardia Duo Strip
Formalin-ether concentration technique
CCA RDT
Koga agar plate culture
Kinyoun staining
Multiplex PCR
Metagenomics analysis

['Soil-transmitted Helminthiasis', 'Schistosomiasis', 'Strongyloidiasis', 'Shigellosis', 'Intestinal Salmonellosis', 'Campylobacteriosis', 'Aeromonas Spp. Infections', 'Giardiasis', 'Amoebiasis', 'Dientamoebiasis', 'Cryptosporidium Spp. Infections']

Soil-transmitted Helminthiasis
Schistosomiasis
Strongyloidiasis
Shigellosis
Intestinal Salmonellosis
Campylobacteriosis
Aeromonas Spp. Infections
Giardiasis
Amoebiasis
Dientamoebiasis
Cryptosporidium Spp. Infections


DULCIS (D-dimer and ULtrasonography in Combination Italian Study)

Summary: The purpose of this study is to evaluate the efficacy and safety of a standardized procedure to establish the optimal duration of anticoagulation in patients with venous thromboembolism.
Inclusion criteria: inclusion criteria:

 Age > 18 years first episode of objectively documented symptomatic idiopathic VTE, either proximal lower extremity deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

 Unprovoked or idiopathic , or associated with one or more of the following favouring factors

 · - minor general surgery, arthroscopy or laparoscopy

 pregnancy or puerperium

 hormonal treatment (contraceptive or replacement therapy)

 travel

 minor traumas

 hospitalization in a medical ward

 reduced mobility (non complete immobilization) at least six months of VKA therapy ( or other type) for at least 3 months and not longer than 12 months ability to provide informed consent

Exclusion criteria: :

 Two or more episodes of objectively documented proximal DVT and or PE ( previous distal of superficial vein thrombosis are not


Usefulness of Chest Wall Tenderness as Bedside Test to Exclude Acute Coronary Syndrome in Different Demographic Groups

Summary: To determine the significance of a simple bedside clinical test (chest wall tenderness) to exclude myocardial ischemia in different demographic groups.
Inclusion criteria: inclusion criteria: All patients over the age of 18 years presenting with the leading symptom of first time or recurrent acute chest pain in the emergency room of the Department of Internal Medicine, University Hospital of Zurich.

Exclusion criteria: :

 Missing informed consent.

 Cardiopulmonary unstable patients.

 No self reported chest pain.

 Recent thoracic surgery within1 year, inflammatory joint disease, fibromyalgia, cardiogenic shock.

['Clinical examination: chest wall tenderness']


Control of Major Bleeding After Trauma Study

Summary: Bleeding is the most avoidable cause of death in trauma patients. Up to one-third of severely injured trauma patients are found to be coagulopathic and forty percent of the mortality following severe injury is due to uncontrollable hemorrhage in the setting of coagulopathy. It has been established that early administration of fresh frozen plasma decreases mortality following severe injury, replacing lost coagulation factors, improving the coagulopathy and restoring blood volume. This study will determine if giving plasma to severely injured trauma patients during ambulance transport versus after arrival to the hospital will help reduce hemorrhage, thus decreasing both total blood product administration and mortality.
Inclusion criteria: inclusion criteria:

 Age>=18 years

 Acutely injured

 SBP<70 mmHg or SBP 71-90 mmHg with heart rate (HR)>108 beats per minute.

Exclusion criteria: :

 Visibly or verbally reported pregnant women

 known prisoners

 unsalvageable injuries (defined as asystolic or cardiopulmonary resuscitation prior to randomization)

 known objection to blood products

 the patient has an opt-out bracelet or, necklace or wallet card

 a family member present at the scene objects to the patient's enrollment in research.

['Type AB plasma', 'Crystalloid fluid (standard of care for resuscitation)']


Oral Probiotics Reduce Group B Streptococci Colonization in Pregnant Women

Summary: The purpose of this study is to examine whether daily use of oral gelatin capsules containing dried viable Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 can reduce the GBS colonization rate of vagina and rectum in pregnant women who present with GBS-positive diagnosed by GBS culture at 35-37 weeks gestation.~This study is a prospective double blind randomized clinical trial. Vaginal and rectal GBS screening culture are carried out for all pregnant women at 35-37 weeks of gestation in our out-patient department. Subjects with vagina and rectum GBS colonization are invited to participate in our study after informed consent. A total of 200 pregnant women will participate in the study during the 12-months trial period. They are randomly assigned to one of the two groups. The study group is treated with two oral capsules of probiotics once daily (before sleeping) for 14 days, and the control group will take 2 capsules of placebos. Vaginal and rectal GBS culture is repeated for all participators 2 weeks later. All participators will treated according to GBS guideline by CDC in 2002 during laboring.
Inclusion criteria: inclusion criteria:

 pregnant women with positive GBS screening culture at 35-37 weeks of gestation

 singleton gestation

 subjects with agreement to abstain from the use of any systemic or intravaginal antibiotic, anti-fungal agents, or any other intravaginal product (i.e., contraceptive creams, gels, foams, sponges, lubricants, douches, etc) throughout the trial period

Exclusion criteria: :

 multiple gestations

 subjects with impaired immunity , diabetes or other significant disease or acute illness that in the investigator's assessment could complicate the evaluation

 vaginal or systemic antibiotics or antifungal therapy within 2 weeks of the screening visit.


Special Drug Use Investigation for LAMICTAL Bipolar

Summary: This post-marketing surveillance study is designed to collect and assess information on safety and effectiveness of lamotrigine tablets in patients with bipolar disorder in routine clinical practice.~(LAMICTAL is a trademark of the GlaxoSmithKline group of companies.)
Inclusion criteria: inclusion criteria:

 Patients with bipolar disorder

 Patients treated with lamotrigine tablets for the first time

Exclusion criteria: :

 Not applicable


Extracolonic Findings on Computed Tomography (CT) Colonography

Summary: The ACRIN 7151 trial will use medical records abstraction data from participants with extracolonic findings (ECFs) reported from the ACRIN 6664 National CT Colonography Trial to: 1) measure incidence of diagnostic imaging, hospitalization, and interventional procedures associated with ECFs reported on computed tomography colonography (CTC), delineated by type of ECF; 2) determine potential predictors of follow-up diagnostic imaging, hospitalization, and interventional procedures, delineated by type of ECF; and 3) evaluate the clinical/pathologic diagnoses associated with indeterminate but potentially significant ECFs. These data can be used to incorporate ECFs into existing models on the cost-effectiveness of CTC in colorectal cancer screening and can potentially be used to develop guidelines for the reporting and management of ECFs.
Inclusion criteria: No participant sub-populations will be excluded prior to selection (the E1 population will be matched to the Case Group populations).

 Data from the 15 participating sites from the ACRIN 6664 trial provide a study data set of 2531 participants, broken down into a total target study data set of 520 participants. Participants will be distributed into one of three cohorts as follows:

 The Case Group will target consenting 141 participants from the cases with indeterminate but potentially significant findings (E3/E4s) other than pulmonary nodules.

 The Pulmonary Nodules Case Group will comprise 119 cases with E3/E4 ECFs characterized as pulmonary nodules.

 The E1 Control Group will be drawn from the 866 E1 ECF cases to create a cohort of 260 E1ECF cases. The Control Group for comparison with the Case Group and the Pulmonary Nodules Case Group will be selected at the Biostatistics and Data Management Center (BDMC). The BDMC will match E1 141 controls to the 141 case-group participants with indeterminate but potentially significant findings (E3/E4s). The BDMC will also match 119 E1 controls to the 119 E3/E4 pulmonary nodules cases. Controls will be matched by site, age caliper (5 years), and sex where possible. Where an appropriate match cannot be obtained, the matching criteria will be relaxed. If potential participants decline study consent, we will then best-match additional cases for the appropriate group to maintain target populations. Any additional cases beyond the initial 520 participants identified for medical record collection will be matched as feasible.
Exclusion criteria:

['Solitary Pulmonary Nodules', 'Multiple Pulmonary Nodules', 'Renal Neoplasms', 'Adrenal Gland Neoplasms', 'Aortic Aneurysm, Abdominal', 'Liver Neoplasms', 'Adnexal and Skin Appendage Neoplasms', 'Lymphadenopathy', 'Pancreatic Neoplasms']

Solitary Pulmonary Nodules
Multiple Pulmonary Nodules
Renal Neoplasms
Adrenal Gland Neoplasms
Aortic Aneurysm
Abdominal
Liver Neoplasms
Adnexal and Skin Appendage Neoplasms
Lymphadenopathy
Pancreatic Neoplasms


Prognosis Assessment of the Increase of GADD34 Gene Expression for Patient Suffering From Systemic Lupus Erythematosus

Summary: Given that GADD34 has been described as a potential key regulator of pro-inflammatory cytokine production in human and elevated blood marker in SLE patients, this study aim to prove that the GADD34 RNA level in mononuclear blood cells can be used as a prognostic marker to assess the risk of SLE flare.
Inclusion criteria: inclusion criteria:

 man and women over 18 Years old.

 suffering from SLE (American College of Rheumatology criteria).

 without SLE flare for 3 months.

 with a signed consent and social security affiliation (required in France).

Exclusion criteria: :

 Viral infection within 15 days.

 Other chronic inflammatory disease.

 People with special protection (defined in articles : L1121- §5-8 et articles L3212-§1-3 of French health care law).


Clipless Laparoscopic Cholecystectomy Using Harmonic Scalpel in Cirrhotic Patients a Prospective Randomized Study

Summary: This study included group (A) (60 patients with liver cirrhosis and complaining of gall stone) in whom LC was done using traditional method (TM) by clipping both cystic duct and artery and dissection of gall bladder from liver bed by diathermy, and group (B) (60 patients with liver cirrhosis and complaining of gall stone) LC was done using harmonic scalpel (HS) closure and division of both cystic duct, artery and dissection of gall bladder from liver bed by harmonic scalpel. The Intraoperative and postoperative parameters were collected included duration of operation, postoperative pain, and complications.
Inclusion criteria: inclusion criteria:

 patients with liver cirrhosis with symptomatic gall bladder stone

Exclusion criteria: :

 patients above 80 years old,

 patients with history of upper laparotomy,

 patients with common bile duct stones

 and pregnant females.

['LC was done using traditional method', 'LC was done using harmonic ACE']

LC was done using traditional method
LC was done using harmonic ACE


Nicotine Patch as an Analgesic Adjuvant After Surgery

Summary: Effect of nicotine patch as an adjutant for acute pain after surgery.
Inclusion criteria: inclusion criteria:

 Adult ASA 1-2

Exclusion criteria: :

 Cardiovascular disease

 Former smoker

 Pregnant

 Nursing

 Asthma

['nicotine patch', 'nicotine patch', 'placebo', 'placebo']

nicotine patch
nicotine patch
placebo
placebo


Restore Calcium Alginate Dressing, Silver vs Aquacel Ag in the Treatment of Critically Colonized Venous Leg Ulcers

Summary: Calcium alginate dressings with silver have been found to be safe and effective for use for leg ulcers. The primary objective is to compare Restore Calcium Alginate Dressing, Silver to AqualCel Ag Dressing on the following parameters: No further progression toward infection (bioburden), ease of application and removal, and percent progression to closure. The secondary objective is to obtain photographic documentation of the leg ulcers during the course of the study.
Inclusion criteria: inclusion criteria:

 Is 18 years or older; male or female.

 Previous diagnosis of venous insufficiency proven by a positive venous duplex with reflux.

 Has a venous ulcer with a wound area between 5 cm2 - 40 cm2.

 Has an ankle brachial index (ABI) >0.8.

 Has a venous ulcer with duration less than 24 months.

 Has a venous ulcer which is critically colonized (not infected) based on the Lazareth Study Model. Ulcers are considered to be critically colonized if at least three of the five following signs are present:

 Severe spontaneous pain between two dressing changes,Perilesional erythema,Local edema,Malodour,Heavy Exudation

 Is currently using Profore as their standard of care.

 Has not received antibiotics for 6 weeks prior to enrollment.

Exclusion criteria:

 Has an allergy to one of the components of the dressings (calcium alginate, hydrocolloid [carboxymethylceullose], silver).

 Is currently on antibiotics.

 Has a negative venous duplex.

 Is unable to tolerate 4 layer compression.

 Is unable to continue contact with the investigator for a period of at least two weeks.

 Is unwilling or unable to comply with the study protocol.

['Restore Calcium Alginate Dressing', 'AquaCel Ag Wound Dressing']

Restore Calcium Alginate Dressing
AquaCel Ag Wound Dressing


Use of MigraineBoxTM Head and Neck Cooling Bath for Treatment of Primary Headache in the Emergency Department

Summary: MigraineBoxTM is a simple, contoured cooling bath for the head and neck. Effectiveness of MigraineBoxTM will be studied in primary headaches in the emergency department. The user simply reclines his/her head and neck into this device that has contours that support the head and neck. Luke warm water is filled into the MigraineBoxTM before use and then a frozen insert is placed inside. This will gradually cool the water surrounding the patient's head and theoretically provide headache relief.
Inclusion criteria: inclusion criteria:

 18-85 years old

 Benign headache

 Physician intends to treat headache pain in the ED with either droperidol, prochlorperazine, or a parenteral narcotic

Exclusion criteria: :

 Unable to provide informed consent

 Headache due to trauma, subarachnoid hemorrhage, meningitis, intracerebral bleed, cranial tumor, sinusitis, dental pathology, temporomandibular joint dysfunction, glaucoma, or systemic infection

 Known renal impairment

 Known hepatic impairment

 A history of coronary artery disease, peripheral vascular disease, or cerebrovascular disease

 Perforated ear drum

 Pregnant


Molecular Microbiology in Osteo-arthritis Infection

Summary: Osteoarticular infections are painful and disabling diseases that require antimicrobial treatment adapted to the microorganisms implicated. Microbiological cultures are currently regarded as the reference for identification of pathogenic bacteria. However, the sensitivity of these cultures is very variable and depends both on the context in which clinical samples are taken, and on the pathogen involved. The rate of detection varies according to infection type: from 50 to 70% for infectious spondylodiscitis, 65 to 95% for prosthetic joint infections, 50% for gonococcal arthritis and 90% for non-gonococcal arthritis. The aim of the study is to evaluate the diagnostic performances of microbiological cultures and molecular methods in case of osteoarticular infections. The gold standard will be established by an expert group of osteoarticular infection (composed by a bacteriologist, a radiologist, a surgeon, an anatomy-pathologist and a rheumatologist), which established the final diagnosis of infected or not infected patients.
Inclusion criteria: inclusion criteria:

 Patient are more than 18 years old

 Patient who do not declined to have his medical records reviewed for research

 Spondylodiscitis (S) group:

 Patients suspected of Discitis and/or Vertebral Osteomyelitis is defined by the need of spinal biopsy in infectious context. Spinal biopsies will be justified by one or more clinical or imaging findings:

 Clinical presentation

 Spinal pain unrelieved by rest

 Localized tenderness, Neurological deficits or limited range of motion

 Fever > 38°C

 Imaging findings (plain radiographs, MRI or CT):

 Erosions of end plates on adjacent vertebral bodies

 Decreased height of the intervertebral disk

 Presence of a nonvascularized zone suggesting presence of pus or necroses in intervertebral, epidural space or in paraspinal soft-tissues

 Prosthetic Joint Infection (PJI) Group

 Patients suspected of Prosthetic Joint Infection were defined by the need of surgical revision for diagnostic or therapeutic aiming in infectious context. This revision will be justified by one or more clinical, biological or imaging findings:

 Clinical presentation

 Persistent joint pain

 Fever > 38°C

 Erythematous, swollen, fluctuant, and/or tender surgical wound

 Wound dehiscence

 Limited range of joint motion

 Biological findings

 CRP > 10 mg/l

 Synovial leukocytes count > 1500/mm3 and polymorphonuclear leukocytes > 65%

 Imaging findings

 Prosthesis loosening: Periprosthetic osteolysis, progressive peri-prosthetic edging

 Scintigraphy by means of a technetium (Tc99m) scan, gallium citrate (Ga67) scan, or indium (In111)-labeled leukocyte showing fixation around the prosthesis.

 Septic arthritis (SA) Group

 Patients suspected of Septic arthritis without prosthesis were defined by the need of synovial punction and/or biopsy justified by one or more clinical, biological or imaging findings:

 Clinical presentation

 Acute joint pain and/or swelling

 Adenopathy near inflammatory joint

 Fever > 38°CBiological findings

 WBC > 10 000/ mm3

 CRP > 10 mg/l

 Synovial leukocytes count > 2000/mm3 or polymorphonuclear leukocytes > 90%

 Imaging findings:

 Capsular and surrounding soft-tissues swelling

 Synovial notch and/or demineralization

 Periarticular Abscess

Exclusion criteria: :

 Patients already include.

 Patient without health insurance

 Antibiotic treatment before sampling does not constitute an exclusion criterion

['Microbiological cultures and Molecular biology']


The Effect of Protandim Supplementation on Oxidative Damage and Athletic Performance

Summary: Nutrition supplementation with antioxidants have been discussed as a way to further enhance overall well-being of athletes, promote faster recovery, and improve overall performance. The use of Protandim, a nutritional supplement containing 5 botanicals (Bacopa extract 150 mg; milk thistle 225mg; ashwagandha 150 mg; green tea 75 mg; turmeric 75 mg) has shown promise in an earlier study by reducing oxidative stress and increasing the amount of the anti-oxidant enzymes in the blood.~The purpose of this study was to examine the effect of ~90 day Protandim supplementation on 5-km running performance and on acute and long term oxidative damage as assessed by blood markers. Secondarily, another purpose of this study examined the effect of Protandim supplementation on other blood parameters (such as antioxidant enzyme concentrations) and measures of quality of life. The experiment was double-blind, placebo controlled. The study addressed two main questions and two secondary questions:~Main Question 1: Does regular supplementation of Protandim (675 mg/day for 90 days) improve 5-km running times? Hypothesis: Protandim would improve 5-km running time by 0.5 min (SD 1-min). This is equivalent to an effect size of 0.5. The placebo group will have no change in performance.~Main Question 2: Does regular supplementation of Protandim (675 mg/day for 90 days) reduce oxidative damage at rest as assessed by lipid peroxides (TBARS) in runners? Hypothesis: Based on the data by Nelson et al. (2006), oxidative damaged would be reduced by 40% (effect size = 4.8).~Secondary Question 1: Does regular supplementation of Protandim (675 mg/day for 90 days) in runners reduce the increase in oxidative damage post-race compared to pre-race as assessed by lipid peroxides (TBARS)? Hypothesis: Based on the data by Kyparos et al. (2009), we expected a 45% increase in TBARS post-exercise compared to pre-exercise (effect size of 3.6). However, we expected that those that are on Protandim for 90 days will only have 31% increase in TBARS post-race (effect size = 2.5) [based on changes in pre-post lipid peroxides from Arent et al. (2010)].~Secondary Question 2: Does regular supplementation of Protandim (675 mg/day for 90 days) improve quality of life according to WHOQOL-BREF (Skevington, Lotfy, O'Connell, & Group, 2004)? Hypothesis: There would be a statistical improvement in the quality of life post-Protandim supplementation which a small effect size improvement of 0.33.
Inclusion criteria: inclusion criteria:

 Healthy, non-pregnant subjects between 18 and 55 years of age. Apparently healthy is classified as A-1, A-2, or A-3 according to the American Heart Association

 http://circ.ahajournals.org/content/97/22/2283/T6.expansion.html

 Subjects have to achieve a classification of local class based on age-graded time USA Track & Field. The age-graded time is the finish time adjusted to that of an open division participant using a factor for age and gender. Thus, the times for women and older participants are adjusted downward, while the times for most open division participants (such as 25-year-old men) remain the same. For example, a 55 year old woman has to run 29 minutes 45 seconds or better to be in the study:

 http://www.usatf.org/statistics/calculators/agegrading/

 For a man the same age, the equivalent time would be 25 minutes 2 seconds. This is approximately 60% of the speed of the current world record time for that age.

 Subjects who will abstain from taking any nutritional supplements for the duration of the study, including vitamins and mineral supplements (Exception, ferrous sulfate, elemental iron, Vitamin D, Calcium). Subjects will also abstain from taking any over the counter products (herbals, melatonin, St. John's Wort, etc…) for the duration of the study.

 The
Exclusion criteria:  will be the following:

 Under 18 and over 55 years of age; those who are not apparently healthy is classified as A-1, A-2, or A-3 according to the American Heart Association.

 Subjects who are not able to run 5-km in the time required for their age and gender.

 Subjects that will continue to take nutritional supplements, including over the counter products, for the duration of the study, including vitamins and mineral supplements (exception: Ferrous sulfate, Elemental iron, Vitamin D, Calcium).

 Subjects that are taking prescription medications with the exception of birth control.

 Known allergy or sensitivity to milk thistle, Bacopa monnieri, Ashwagandha, turmeric (or ginger), tea, its parts, caffeine, tannins, or members of the Theaceae family.

['Protandim Dietary Supplement', 'Placebo Group']

Protandim Dietary Supplement
Placebo Group


Evaluation of Parenting Interventions to Decrease Family Risk for Child Maltreatment

Summary: The purpose of this research is to evaluate specific parenting programs that aim to improve the family's ability to keep children physically safe and emotionally secure. We would like to learn more about how the treatments actually help families and to find out how an intervention that focuses on child health and safety compares with one that focuses on the parent and child relationship. We also want to determine whether participating in one program type versus the other results in further reports for child maltreatment.
Inclusion criteria: inclusion criteria:

 resident of Durham, NC

 a child between the ages of 0-7 was the focus of the Department of Social Services report

 child's caregiver was the focus of the report

 Child Protective Services report occurred on or after June 1, 2004

 family is English speaking

 Sexual abuse was not confirmed or highly suspicious during an evaluation

Exclusion criteria: :

 Child Protective Services report of sexual abuse that was confirmed or highly suspicious

['Parent-Child Interaction Therapy', 'Health and Safety', 'Early Relationships']

Parent-Child Interaction Therapy
Health and Safety
Early Relationships


Accuracy of Surgeon-performed Ultrasound in Detecting Gallstones - a Validation Study

Summary: Aims: To prospectively investigate the accuracy of surgeon-performed ultrasound for the detection of gallstones.~Methods: 179 adult patients, with an acute or elective referral for an abdominal ultrasound examination, were examined with a right upper quadrant ultrasound scan by a radiologist as well as surgeon. The surgeons had undergone a four-week long education in ultrasound before participating in the study. Ultrasound findings of the surgeon were compared to those of the radiologist, using radiologist-performed ultrasound as reference standard.
Inclusion criteria: inclusion criteria:

 Patients referred to the radiology department for an abdominal ultrasound

 Age > 18 years

Exclusion criteria: :

 Inability to communicate with the examiner

 Referral for intervention

 Metastasis screening

 Referrals concerning contrast enhanced examinations


Study of a Tiotropium Inhaler For Shortness of Breath in Advanced Non-Small Cell Lung Cancer

Summary: The feeling of shortness of breath is very common in lung cancer. It is uncomfortable for patients and upsetting for their family. Although drugs like morphine and oxygen can help some patients feel better, they don't help everybody, and they are not used in patients with early symptoms. More relief is needed for these patients. The investigators are studying a drug called tiotropium, which is used in emphysema. It is an inhaler that opens the airways to allow easier breathing. Every patient will get the drug but also a placebo, in a random (flip of a coin) order. They will get each for 2 weeks. The investigators will see if they feel better with the drug.
Inclusion criteria: inclusion criteria:

 Histologically or cytologically proven incurable stage IIIb or stage IV non-small cell lung cancer.

 Dyspnea as defined by a score of 2 or higher on the 10-point Dyspnea Numeric Scale (Appendix 2).

 New dyspnea or worsening dyspnea within the last 6 months per patient reporting.

Exclusion criteria: :

 Age < 18.

 An FEV1 / FVC ratio < 0.7 with an FEV1 of < 80% predicted post-bronchodilator.

 Life expectancy < 3 months.

 Significant worsening of dyspnea over the last week such that an acute cardiac or respiratory condition is considered likely (e.g. pneumonia, heart failure).

 Myocardial infarction within the previous month.

 Heart rate ≥ 120.

 Active tuberculosis or tuberculosis receiving antibiotic therapy.

 Current or previous use of ipratropium, tiotropium, or oxitropium (see Appendix 6).

 Sensitivity to atropine.

 Pre-existing diagnosis of asthma or moderate to severe Chronic Obstructive Pulmonary Disease

 Use of beta-adrenergic bronchodilators more than once per week.

 Use of experimental therapy with known cholinergic or adrenergic effects.

 Uncontrolled glaucoma.

 Urinary retention.

 An active upper or lower respiratory infection or having taken antibiotics for any recent respiratory infection within 4 weeks.

 Symptomatic pleural or pericardial effusion.

 Evidence of reversible proximal endobronchial obstruction.

 Oxygen saturation < 90%.

 A hemoglobin of < 100 g/litre. Testing is to be within 4 weeks of randomization.

 Calculated or urine creatinine clearance ≤ 50 mL/min (see Appendix 5 for calculation). Testing it to be within 4 weeks of randomization.

 Weight loss > 10% of usual body weight within 6 months.

 Known pregnancy or lactating.

 Unable to independently fill out quality of life forms or give informed consent.

 -


Hyperthermic Intraperitoneal Oxaliplatin for Peritoneal Malignancies

Summary: RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Peritoneal infusion of heated and nonheated chemotherapy drugs after surgery may kill more tumor cells.~PURPOSE: This phase I trial is studying the side effects and best dose of hyperthermic intraperitoneal oxaliplatin followed by intraperitoneal leucovorin and fluorouracil in treating patients with peritoneal cancer.
Inclusion criteria: inclusion criteria:

 Patients must have histologic proof of peritoneal metastases (includes adenomucinosis)

 Complete tumor resection possible (may include liver metastasis if treatable by resection or radiofrequency ablation)

 Patients may have received previous chemotherapy (except peritoneal) and/or immunotherapy. If previous chemotherapy, at least 4 weeks must have passed since last dose.

 Patients may have received previous radiation therapy, however radiation to the large bowel, small bowel and/or stomach will make the patient ineligible for this study.

 Patients must have a Karnofsky performance score of ≥ 80%.

 Adequate hematologic, renal and hepatic function within 14 days of registration defined as:

 White blood count (WBC) ≥ 3,000

 platelet count ≥ 70,000,

 serum bilirubin ≤ 2.0 mg/dL,

 serum creatinine ≤ 1.5 mg/dL

 Patients must be at least 18 years of age

 Patients must be able to provide informed consent

Exclusion criteria: :

 Metastatic disease is present outside the peritoneal cavity

 Diagnosis of mesothelioma

 Grade 2 or higher sensory neuropathy at time of study enrollment

 History of allergic reaction to platinum compounds

 Pregnant or lactating women. Pregnancy is a contraindication for receiving therapy, thus where relevant, patients will be required to use effective birth control. The agents used in this study include those which are pregnancy category D - clear evidence of risk in pregnancy. There is no information on the excretion of agents into breast milk therefore patients must refrain from breastfeeding while receiving study therapy.

 Previous peritoneal chemotherapy.

 Patients with uncontrolled concurrent medical problems (i.e. diabetes mellitus) or history of uncontrolled cardiovascular disease (no history of hospitalization for acute myocardial infarction or congestive heart failure (CHF) within 3 months prior to registration).

 Patients have psychiatric or addictive disorders that preclude obtaining informed consent.

['fluorouracil', 'leucovorin calcium', 'oxaliplatin', 'cytoreductive surgery']

fluorouracil
leucovorin calcium
oxaliplatin
cytoreductive surgery


Efficacy Evaluation of the HEART Pathway in Emergency Department Patients With Acute Chest Pain

Summary: Our research will examine a chest pain care strategy, called the HEART pathway, which is designed to correctly identify Emergency Department patients at high-risk for cardiovascular events, likely to benefit from further testing, and patients at very-low-risk for cardiovascular events, who may be safely discharged home. By using an individual's risk assessment to determining testing, we hope to improve the quality and efficiency of the care delivered to Emergency Department patients with chest pain. Our study will determine if the HEART pathway, which combines a clinical decision rule, the HEART score, and two serial troponin measurements, will reduce stress testing and cardiovascular imaging, decrease hospital length of stay, and reduce cost compared to usual care, while maintaining safety.
Inclusion criteria: inclusion criteria:

 Age greater than or equal to 21 years

 Chest discomfort or other symptoms consistent with possible ACS

 The treating physician feels the patient could be discharged home if cardiac disease was excluded

Exclusion criteria: :

 New ST-segment elevation in contiguous leads on any electrocardiogram (>/= 1 mV)

 Unstable vitals signs: symptomatic hypotension at the time of enrollment (systolic < 90 mm Hg), tachycardia (HR>120), bradycardia (HR<40), and hypoxemia (<90% pulse-oximetry on room air or normal home oxygen flow rate)

 Terminal diagnosis with life expectancy less than 1 year

 A non-cardiac medical, surgical, or psychiatric illness determined by the provider to require admission, increase risk of objective cardiac testing, or prevent immediate discharge following negative testing.

 Prior enrollment

 Incapacity or unwillingness to provide consent and comply with study procedures

 Non-English speaking

 Sub-study I & II

 inclusion criteria:

 ED attending physicians

['Acute Coronary Syndrome', 'Chest Pain']


Assessment of Efficacy & Safety for a New Wound Dressing Urgo 310 3166 in the Local Treatment of VLU or Mixed Leg Ulcers

Summary: Assessment of efficacy and safety for a new wound dressing URGO 310 3166 in the local treatment of venous or mixed leg ulcers: a European, randomised clinical trial.
Inclusion criteria: inclusion criteria:

 Patient over 18 years old who has provided his/her written informed consent,

 Patient who can be monitored by the same investigation team throughout the whole duration of the study,

 Patient who agrees to wear an effective venous compression system every day, associated with the trial dressing,

 Leg ulcer with an Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3,

 Ulcer area > or equal to 5cm2,

 Ulcer duration > or equal to 6 months,

 Ulcer presenting a the surface wound bed covered with 50% or more by sloughy tissue,

 Moderately or heavily exudative ulcers.

Exclusion criteria: :

 Clinical infection on the wound bed.

:

 Clinical infection on the wound bed.