The Assessment of a Weight-Gain Agent for the Treatment of Olanzapine-Associated Anti-Obesity Agent in Patients With Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, and Bipolar I Disorder

Summary: Olanzapine is currently marketed for the treatment of schizophrenia and acute manic episodes with bipolar 1 disorder. This Anti-obesity Agent is currently marketed for the management of obesity. In this study, the Anti-obesity Agent is being tested to see if it can treat weight gain that may be associated with taking olanzapine.~The purposes of this study are to determine the safety of olanzapine when given in combination with the Anti-obesity Agent and any side effects that might be associated with it and whether weight-gain agent can help treat weight gain that may be associated with taking olanzapine.
Inclusion criteria: Eligibility Criteria:

 You must be between the ages of 18 and 65. If you have reached your 66th birthday, you will not be able to participate.

 You must have been diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, or bipolar I disorder and be taking olanzapine.

 You must be able to visit the doctor's office as scheduled for the next 4 months.

Exclusion criteria: :

 You have a history of an illness that would cause weight loss or gain in the near future.

 You have taken remoxipride within the past 6 months.

 You are allergic to olanzapine or Anti-obesity Agent.

 You have uncontrolled high blood pressure, congestive heart failure, or have had a stroke.

 You have a serious medical illness, such as heart, liver, or kidney disease.

 You are pregnant or breast feeding.

['Schizophrenia', 'Psychotic Disorders', 'Bipolar Disorder']

Schizophrenia
Psychotic Disorders
Bipolar Disorder


Burden of Illness in Atrial Fibrillation

Summary: The overall goal of this retrospective registry study is to investigate the burden-of.illness in atrial fibrillation (AF) in Denmark. Several Danish registries will be utilized to collect information on the diseases epidemiology including incidence and prevalence of AF and stroke as well as a stroke risk stratification of the Danish AF-population, the clinical and economical burden (in terms of direct and indirect cost) of AF and stroke to Danish patients, healthcare providers / healthcare system and society as well as describing treatment patterns with anticoagulant agents and their consequences in terms of stroke, bleeds, death and according cost in a real-life setting.
Inclusion criteria: inclusion criteria:

 Primary and secondary diagnosis with AF;

 The base population of AF patients will be identified in the National Patient Registry. For a given period of time (2000-2013, both years inclusive) all patients with a hospital contact (admission, outpatient visit or ER visit) and for whom AF was the primary or secondary diagnosis code (ICD10-code: DI480, DI481, DI482, DI483, DI484, DI489) will be included.

Exclusion criteria: :

 Patients younger than 18 and older than 90 years of age.


A Comparison of Midazolam and Zolpidem as Oral Premedication in Children

Summary: The purpose of this investigator-initiated study is to compare the efficacy of oral midazolam and zolpidem for preoperative sedation, anxiety of patient, and caregiver anxiety at the time of separation, and ease of mask acceptance at induction in children. Subjects will be randomized to receive oral medication midazolam or zolpidem approximately 30 minutes prior to surgery. No placebo will be administered in this study. Subjects will be male and female children between 2 and 9 years of age. In total, subject participation will last approximately the duration of their preoperative, perioperative, and immediate postoperative period. A member of the research team will recruit subjects preoperatively in the operating room holding area prior to surgery. Consent will take place at the time of recruitment in the preoperative holding area following a detailed explanation of the study and medications involved in the study. Participants will be of ASA (American Society of Anesthesiologists) class I-II, undergoing surgical procedures of at least 2 hours duration, and expected to remain inpatient for at least 23 hours postoperatively.
Inclusion criteria: inclusion criteria:

 Pediatric patients ages 2-9 years

 ASA class I-II

 inpatient surgeries of at least 2 hours duration

 requiring postoperative admission of at least 23 hours
Exclusion criteria: :

['Parental/Caregiver Anxiety', "Child's Anxiety"]

Parental/Caregiver Anxiety
Child's Anxiety


Prospective Comparison of Large vs. Small Diameter Esophageal Stents for Palliation of Malignant Dysphagia

Summary: Esophageal cancer often causes difficulty swallowing (dysphagia) that can be relieved by placement of a stent (a flexible, expandable tube that props open the blockage caused by the cancer). Stents are effective but can cause complications. Stents come in different diameters. The purpose of this study is to learn if stents of different diameters are more or less effective for treatment of dysphagia caused by esophageal cancer.
Inclusion criteria: inclusion criteria:

 age ≥ 18 years

 dysphagia due to unresectable esophageal cancer

 participant resides within 50 km of Tenwek Hospital

 tumor is ≤ 9 cm in length and > 2 cm distal to the upper esophageal sphincter (UES)

 no esophago-respiratory fistula (ERF) or suspected perforation is present

Exclusion criteria: :

 unable to provide written informed consent


Long Term Treatment With Zolpidem: Nightly and Intermittent Dosing

Summary: We want to assess whether how and when one takes sleep medication results in similar or different outcomes with respect to symptom relief. We also want to know whether taking medication for a period of time provides continued benefit once the medication is stopped.
Inclusion criteria: inclusion criteria:

 Ages 25 - 55

 a stable sleep/wake schedule with a preferred sleep phase between 10:00 p.m. and 8:00 a.m.

 Patients with Primary Insomnia will meet diagnostic criteria for Psychophysiologic Insomnia according to the International Classification of Sleep Disorders manual (ICSD).

 complaint of disturbed sleep must have the following characteristics: >30 minutes to fall asleep, and/or >30 minutes wake after sleep onset time, a total sleep time of no more than 6.5 hours (or a sleep efficiency of less than 85%), a problem frequency of >4 nights/ week and a problem duration >6 months.

Exclusion criteria: :

 Unstable medical or psychiatric illness

 Use of medication that may cause insomnia or may be reduce the effectiveness of zolpidem (e.g. selective serotonin reuptake inhibitors(SSRI's), steroids, bronchodilators, calcium channel blockers, beta blockers, etc.)

 symptoms suggestive of sleep disorders other than insomnia

 polysomnographic data indicating sleep disorders other than insomnia

 Evidence of active illicit substance use or fitting criteria for alcohol abuse or dependence

 inadequate language comprehension

 pregnancy

 first-degree relatives with bipolar disorder or schizophrenia

['Insomnia', 'Primary Insomnia', 'Psychophysiologic Insomnia']

Insomnia
Primary Insomnia
Psychophysiologic Insomnia


Concurrent Chemoradiation With Cisplatin Every 3 Week in Advanced Cervical Cancer

Summary: Concurrent chemoradiation (CCRT) is the standard therapy for locally advanced cervical cancer.~However, the most effective chemotherapy regimen is controversial. Weekly cisplatin, hydroxyurea + cisplatin, 5-FU + cisplatin are tested in clinical trials.~Weekly cisplatin needs frequent hospital visits and had a poor compliance profile in korea.~Combination chemotherapy regimens had more adverse effects than weekly cisplatin without improving outcomes.~We conducted a retrospective analysis comparing weekly cisplatin with cisplatin every 3 weeks and observed favorable outcome for cisplatin every 3 weeks regimen (still not published).~Therefore, we designed a phase 2 trial evaluating the efficacy and feasibility of CCRT with cisplatin every 3 weeks.
Inclusion criteria: inclusion criteria:

 Histologically confirmed cervical cancer

 Clinical stage from 2b to 4a

 Equal to or younger than 75

 Gog performance status 0 - 2

 Anc > 1500/mm3 and platelet > 100000/mm3 and hemoglobin > 10 g/dl

 Serum creatinine < 2.0

 AST, ALT < 3 * upper normal level and serum bilirubin < 1.5 mg/dl

 Expected survival equal to or longer than 6 months

 Who agreed to participate in this study

Exclusion criteria: :

 History of chemotherapy or radiation to abdomen or pelvis

 History of other cancers

 Pleural or pericardial effusion, ascites causing respiratory difficulties equal to or worse than NCI CTCAE grade 2

 History of allergy or hypersensitivity reaction to platinum

 History of atrial or ventricular arrhythmia, or congestive heart failure

 Uncontrolled diabetes, hypertension, or ischemic heart disease

 Myocardial infarction within 6 months

 Sepsis or severe infection

 Pregnant women

 An unapproved therapy within 30 days before enrollment

 Other serious diseases which can threat the safety of participants or impair the ability of participants to participate this trial


Coronary Arteriosclerosis in Patients With Acute Ischemic Stroke

Summary: The specific objectives of this thesis are in a cohort of patients with an acute ischemic stroke,~To establish the degree of coronary arteriosclerosis.~To describe left ventricular systolic and diastolic function in relation to changes of NT-proBNP.
Inclusion criteria: inclusion criteria:

 Age ≥ 18 years old

 Symptoms suggestive of an acute ischemic stroke

 Informed consent

Exclusion criteria: :

 Present intracerebral or subarachnoid haemorrhage

 Present intracerebral vascular malformation

 Present transient ischemic attack

 Prior coronary bypass surgery or percutaneous coronary intervention

 Pacemaker

 Allergy to contrast

 Lack of cooperation

['Ischemic Stroke', 'Myocardial Ischemia', 'Coronary Arteriosclerosis']

Ischemic Stroke
Myocardial Ischemia
Coronary Arteriosclerosis


Impact of Maternal Iron Status on Neonatal Iron Status and Auditory Brainstem Response in the Newborn

Summary: This study aims to determine how maternal Fe status influences placental and neonatal Fe status in pregnant adolescents and to assess the impact of the Fe endowment of birth on functional outcomes as assessed by auditory brainstem responses within 48 h of delivery in neonates born to these adolescents.
Inclusion criteria: inclusion criteria:

 Adolescents (ages 11-18 y) and their newborns will be eligible to participate if the adolescent is carrying a singleton pregnancy, does not have any preexisting medical complications (such as HIV-infection, eating disorders, hemoglobinopathies, malabsorption diseases, steroid use, substance abuse history, or taking medications known to influence iron homeostasis).

Exclusion criteria: :

 Individuals with pregnancy induced hypertension or elevated diastolic blood pressure (>110) will not be eligible to participate in the study. In addition, adolescents who have been previously treated for lead exposure, or those that have been identified as having elevated blood lead concentrations during childhood, will be excluded from the study.

 Data from infants that experience perinatal asphyxia, pathologic neonatal hyperbilirubinemia, respiratory disease, antibiotic therapy (aminoglycosides), CNS infection, sepsis, congenital or middle or external ear lesions, craniofacial anomalies, chromosomal disorders, TORCH (toxoplasmosis, other infections, rubella, cytomegalovirus infection and herpes simplex infection) or those that were clinically unstable with the first 48 h post-delivery will be excluded from ABR studies. Infants born to mothers with positive drug abuse screens at delivery will also be excluded from further study (these screens are automatically run among this age group). Infants that are identified with hearing deficits at birth using the OAE screening will be excluded from the ABR measures.


Olanzapine Versus Comparator in the Treatment of Bipolar Disorder

Summary: The purpose of this trial is compare the efficacy of olanzapine and Lithium Carbonate in the treatment of bipolar disorder, manic or mixed episodes, in Chinese patients.
Inclusion criteria: inclusion criteria:

 Male or female in- or out-patients at least 18 years of age

 Patient must have a diagnosis of bipolar I disorder and currently display acute manic or mixed episodes (with or without psychotic features) according to the DSM-IV based on clinical assessment

 Patients must have a level of understanding sufficient to agree to all tests and examinations required by the protocol

 Patients must have a Y-MRS total score of greater than or equal to 20 at both visits 1 & 2

 Patients must be considered reliable

Exclusion criteria: :

 Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry

 Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months

 Current or past diagnosis of schizophrenia or other psychotic disorder (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV

 Documented history of intolerance to olanzapine or Lithium Carbonate

 Treatment with clozapine within 4 weeks prior to visit 2. Treatment with other antipsychotic drugs or mood stabilizers within 2 days prior to visit 2

['Olanzapine Hydrochloride', 'Lithium Carbonate']

Olanzapine Hydrochloride
Lithium Carbonate


Point of Care 3D Ultrasound for Pediatric Appendicitis: a Pilot Study

Summary: Purpose and Objective: The purpose of this study is to test the feasibility of rapid acquisition of point of care 3D ultrasound for pediatric appendicitis. The study will use a newly developed acquisition method and post-processing technique to create three dimensional image models of the abdomen.~Study activities and population group. The study population will be a convenience sample of patients 18 years and younger with suspected appendicitis, whose clinical care (unrelated to the study) includes ultrasound and/or CT of the abdomen. The study intervention includes acquisition of research ultrasound images, which will not be used for clinical care, and comparison of these images with clinically obtained images. Other clinical data such as surgical and pathology reports will also be reviewed. If not evident from the patient medical record, the final diagnosis will be confirmed by a telephone call to the subject 2 weeks after the initial visit.~Data analysis and risk/safety issues. This is a pilot study intended to determine feasibility and to refine image reconstruction algorithms. Research images will be compared to clinical images to determine the frequency of visualization of the appendix and whether the appendix was deemed normal or abnormal. Comparison of research images with final diagnosis will also occur. The research intervention, an ultrasound exam, has no known safety risks. The only risk to subjects is loss of confidentiality.~This study is observational, not interventional, because the experimental ultrasound will be performed in all subjects and will not be used in the clinical care of patients (consequently, will not have the opportunity to affect clinical outcomes). Experimental images will be reviewed after completion of clinical care and will not be provided to the clinicians caring for the subjects. We are not measuring the effect of the ultrasound examination on the subjects' outcomes.
Inclusion criteria: inclusion criteria:

 Potential subjects must be 0-18 years of age, presenting to the pediatric emergency department for evaluation of right lower abdominal pain and suspected appendicitis.

 The clinical diagnostic plan before subject enrollment must include abdominal ultrasound and/or abdominal CT.

Exclusion criteria: :

 Because ultrasound does not involve the use of ionizing radiation or contrast agents, it is not contraindicated in any patients, although image quality may be nondiagnostic in obese patients. The focus of this study is on acquisition of research 3D POC US images to determine feasibility of use in pediatric patients with suspected appendicitis.

 Patients with BMI >30 or mass >70kg, as these patients are anticipated to have nondiagnostic ultrasound images.

 Ultrasound also requires a gel material be applied to the skin surface as an acoustic transmission medium. Allergy to such gel will be an exclusion criterion.


Whole Exome Sequencing in Finding Causative Variants in Germline DNA Samples From Patients With Congestive Heart Failure Receiving Therapy for Breast Cancer

Summary: This research trial studies whole exome sequencing in finding causative variants in germline deoxyribonucleic acid (DNA) samples from patients with congestive heart failure receiving therapy for breast cancer. Studying samples of germline DNA in the laboratory from patients with congestive heart failure receiving therapy for breast cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to congestive heart failure.
Inclusion criteria: inclusion criteria:

 European American patients with DNA available

 European American patients who developed CHF and patients who did not develop CHF following a full course of treatment with an anthracycline and bevacizumab

 African American cases (based on a drop in left ventricular ejection fraction [LVEF] < 50 or a drop from baseline > 20 points) and African American controls
Exclusion criteria:


Mindfulness Therapy on Disrupted Sleep in Bipolar Disorder

Summary: The investigators propose to investigate the efficacy of a brief (4-session) Body Scan (BS) meditation intervention for individuals with bipolar I disorder with insomnia (i.e. difficulties falling or staying asleep). The investigators will compare the Body Scan intervention with a 4-session brief supportive psychotherapy (SP) intervention. The investigators hypothesize that the Body Scan will improve objective sleep quantity and quality.
Inclusion criteria: inclusion criteria:

 Men and women age 18-65

 DSM-IV diagnosis of bipolar I or II disorder

 HAM-D-17 score < 17 (i.e. low or no depressive symptoms)

 YMRS score < 8 (i.e. no or low manic symptoms)

 Optimized, stable maintenance pharmacotherapy at maximum tolerated dosages in accordance with the revised Texas Implementation of Medication Algorithm

 DSM-IV insomnia A and B criteria are met (i.e. difficulty initiating or maintaining sleep, for at least 1 month) as operationally defined by:

 Insomnia Severity Index score of > 15 (moderate clinical insomnia)

 M1 derived average actigraphic total sleep time < 6 hours, and < 40% average total sleep time in high frequency coupling, as measured with the M1 device over 5 days pre-randomization, corresponding to < 1SD below the mean of the M1 normative comparison sample of healthy control participants.

Exclusion criteria: :

 DSM-IV bipolar I disorder subtype rapid cycling

 DSM-IV manic or mixed episode in the past 2 months

 DSM-IV major depressive episode in the past 2 months

 Psychotropic medication not in accordance with the revised Texas Implementation of Medication Algorithm

 Pregnancy

 Medical illness or non-psychiatric medical treatment that is the likely cause of the sleep disturbance or interferes with study participation

 Neurologic disorder, previous ECT, or history of head trauma (i.e. known structural brain lesion)

 Current or past history of selected DSM-IV Axis I disorders other than bipolar disorder including: organic mental disorder, substance abuse within the past 12 months and/or history of substance abuse for > 1 year; past or current substance dependence (including alcohol), schizophrenia, delusional disorder, psychotic disorders not otherwise specified

 Axis I disorder that needs to be the primary focus of treatment (e.g. current DSM-IV anxiety disorder that disrupts sleep)

 Sleep apnea, restless leg syndrome, or narcolepsy

 Concurrent psychotherapy to BS or SP.

['Body Scan (BS) Meditation Intervention', 'Brief Supportive Psychotherapy (SP)']

Body Scan (BS) Meditation Intervention
Brief Supportive Psychotherapy (SP)

['Bipolar Disorder', 'Insomnia', 'Hypersomnia', 'Sleep Problems']

Bipolar Disorder
Insomnia
Hypersomnia
Sleep Problems


Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis

Summary: Duodenal carcinomas are the leading cause of mortality in patients with Familial Adenomatous Polyposis (FAP) who underwent prophylactic colorectal surgery. The purpose of this study is to determine wether celecoxib combined with ursodeoxycholic acid is an effective chemoprevention strategy to influence the progression of duodenal adenomas to carcinomas in patients with FAP.
Inclusion criteria: inclusion criteria:

 Patients with Familial adenomatous Polyposis: APC-mutation identified or more than 100 colorectal polyps on diagnosis

 Spigelman score of duodenal adenoma equal to II or III

Exclusion criteria: :

 Incapability of signing informed consent

 Active gastric or duodenal ulcer, gastrointestinal bleeding

 Cardiovascular disease or risk:

 Congestive cardiac failure: NYHA class II to IV

 Proven ischemic heart disease and/or cerebrovascular disease

 Risk factors: hypertension, hyperlipidaemia, diabetes mellitus, family history of cardiovascular events (≥2 first degree family members <55 years)

 Renal dysfunction: creatinine clearance below 50mL/min

 Liver dysfunction: albumin below 25 g/L or Child-Pugh-score equal to or below 10

 Known allergic reaction to sulfonamides, NSAIDs or ursodeoxycholic acid

 Use of NSAIDs or ursodeoxycholic acid for more than 1 week during the 6 months prior to the start of the study

 Use of lithium

 Symptomatic gallstones

 Inflammatory bowel disease

 (Possible) pregnancy or breast feeding

['Celecoxib', 'Ursodeoxycholic acid', 'Placebo']

['Familial Adenomatous Polyposis', 'Duodenal Neoplasms', 'Duodenal Polyps']

Familial Adenomatous Polyposis
Duodenal Neoplasms
Duodenal Polyps


Cerebrospinal Fluid Drainage (CSFD) in Acute Spinal Cord Injury

Summary: The purpose of this Phase IIB randomized controlled trial is to evaluate the safety and efficacy of CSFD and to provide a preliminary clinical efficacy evaluation of the combination of CSFD and elevation of mean arterial pressure (MAP) in patients with acute spinal cord injury (SCI). The objectives of the trial are to evaluate (i) efficacy of reducing intrathecal pressure (ITP) by CSFD in patients with acute SCI; (ii) preliminary efficacy of combination of CSFD and elevation of MAP compared to elevation of MAP alone in improving neurologic motor outcomes in patients with acute SCI; and, (iii) safety of intensive CSFD in acute SCI patients.
Inclusion criteria: inclusion criteria:

 Aged 18-75 years inclusive;

 Diagnosis of acute SCI;

 Injury is less than 24 hours old;

 ISNCSCI Impairment Scale Grade A, B or C based upon first ISNCSCI evaluation after arrival to the hospital;

 Neurological level of injury between C4-C8 based upon first ISNCSCI evaluation after arrival to the hospital;

 Women of childbearing potential must have a negative serum β-hCG pregnancy test or a negative urine pregnancy test;

 Patient is willing to participate in the study;

 Informed consent document signed by patient or witnessed informed consent document;

 No contraindications for study treatment(s);

 Able to cooperate in the completion of a standardized neurological examination by ISNCSCI standards (includes patients who are on a ventilator).

Exclusion criteria: :

 Injury arising from penetrating mechanism;

 Significant concomitant head injury defined by a Glasgow Coma Scale (GCS) score < 14 with a clinically significant abnormality on a head CT (head CT required only for patients suspected to have a brain injury at the discretion of the investigator);

 Pre-existing neurologic or mental disorder which would preclude accurate evaluation and follow-up (i.e. Alzheimer's disease, Parkinson's disease, unstable psychiatric disorder with- hallucinations and/or delusions or schizophrenia);

 Prior history of SCI;

 Recent history (less than 1 year) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation, in the opinion of the investigator;

 Is a prisoner;

 Participation in another clinical trial within the past 30 days;

 Acquired immune deficiency syndrome (AIDS) or AIDS-related complex;

 Active malignancy or history of invasive malignancy within the last five years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitely treated. Patients with carcinoma in situ of the uterine cervix treated definitely more than 1 year prior to enrollment may enter the study.

['CSFD and elevation of MAP', 'Maintenance of MAP']

CSFD and elevation of MAP
Maintenance of MAP


Reveal Chagas: Clinical Evidence of the Implantable Cardiac Monitor in Patients With Chagas Disease

Summary: The study Reveal Chagas: Clinical Evidence of the Implantable Cardiac Monitor in Patients with Chagas Disease is a prospective, multicenter, randomized study that is being conducted at several centers in Latin America with commercially available products.~The primary study hypothesis is that patients with implantable cardiac monitors will have a shorter time to the decision to treat for electrical or arrhythmic disorders during the follow-up period.~The geography includes Argentina and Colombia.
Inclusion criteria: inclusion criteria:

 Have Chagas disease, confirmed by two serological tests.

 Provide evidence through any of the following diagnosis methods: Rest ECG, 24 hour Holter monitoring, electrophysiological study, stress test or loop monitoring, at least one electrical disorder consistent with sinus bradycardia greater than 45 and lower than 60 bpm, sinus arrest not greater than 2.0 seconds, second degree atrial sinus block, intraventricular conduction disorders such as right branch, left branch or a bifascicular blockage type, first degree A-V blockage, or of type I second degree AV Block without associated bradycardia, atrial and/or ventricular arrhythmias that do NOT constitute an indication for pacemaker implant, ICD or mapping and radio frequency ablation.

 Be asymptomatic or having minimal isolated unspecific symptoms not consistent with cardiac arrest, aborted sudden death, syncope, frequent and recurrent palpitations, cardiac failure, and lower extremity edema.

 Have ejection fraction of left ventricle >35%

 Be able to give his/her written informed consent.

 Subject should be > 21 years old.

 Be able to return for follow-up visits as required.

Exclusion criteria: :

 Class I or II (according to AHA/HRS/ESC guidelines) indication for final implantation of pacemaker, ICD, or cardiac resynchronizer.

 Exhibit extrinsic causes of sinus dysfunction or A-V blockage.

 Exhibit infiltrative myocardial diseases such as tumors or associated valvular defects.

 Suffer any concurrent disease that may limit the follow up or evaluation.

 Suffer aftereffects of cerebral embolism.

 Suffer ablation or isolation of pulmonary veins previous to their inclusion in the study.

 Not being able or willing to comply with the follow-up schedule.

 Have previous lesions of the spinal cord or aftereffects of skull trauma.

 Have a record of epilepsy.

 Receive pharmacological treatment for other diseases that may modify the autonomic function.

 Have a record of myocardial infarction.

 History of alcohol abuse or drug addiction.

 History of emotional instability, unstable psychiatric disorders or are under treatment for such disorders.

 Have previously implanted pacemakers, cardiodefibrillators or CRT systems.

 Are included or intend to participate in another study of devices during the course of this study.

 Have a clinical condition that may limit life expectancy to < 36 months.

 Use of Antiarrhythmic drugs, except Beta Blockers

['Implantable Cardiac Monitor', 'Standard of Care']

Implantable Cardiac Monitor
Standard of Care


Efficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in Systemic Lupus Erythematosus (SLE) Patients With Corticosteroid Therapy and High Low-Density Lipoprotein (LDL) Cholesterol Level

Summary: Early statin therapy in SLE patients that have high cholesterol level and other atherosclerosis risk should reduce atherosclerosis and coronary artery events in later course of disease. By the way, statin is used in restricted groups of rheumatologists due to awareness of side effects; myositis and hepatitis, that are frequently found in SLE patients more so than other groups of atherosclerosis patients and reporting data of autoimmune diseases that occur after statin use.
Inclusion criteria: inclusion criteria:

 SLE patients that on prednisolone more than 30 mg/day

 Normal liver faction: AST and ALT < 80 mg/dl

 Normal muscle enzyme : CPK < 100 U/L

 LDL cholesterol level > 100 mg/dl

Exclusion criteria: :

 Patients that was treated with pulse methylprednisolone or corticosteroid equivalent to prednisolone > 1mg/kg/day at screening.

 Statin allergy

 On statin treatment before screening

 On cyclosporine, antifugal (azole group), antibiotics (macrolide group), rifampicin, warfarin, phenytoin

 Pregnancy

 Abnormal liver function: AST or ALT > 80 mg/dl

 Abnormal muscle enzyme : CPK > 300 U/L

['Systemic Lupus Erythematosus', 'High LDL Cholesterol Level']

Systemic Lupus Erythematosus
High LDL Cholesterol Level


EEG-Based Brain-Computer Interface Project for Individuals With Amyotrophic Lateral Sclerosis (ALS)

Summary: Amyotrophic lateral sclerosis (ALS) is a progressive neuromuscular condition characterized by weakness, muscle wasting, fasciculations and increased reflexes. Depending on the site of onset, individuals with ALS progressively lose control of their skeletal muscles; bulbar or the extremities. As symptoms worsen and spread, muscle atrophy becomes apparent and upper motor neuron symptoms such as spasticity complicate gait (in lower limb involvement) and manual dexterity (in upper limb involvement). The patients progress to a state of profound disability and have great difficulty in communicating; some may even be entirely locked in to their bodies. The capacity for simple communication could greatly improve their quality of life.~New technologies are giving people with disabilities alternate communication and control options. One such instrument is the EEG-based Brain-Computer Interface (BCI) which can provide both communication and control functions to those who have lost muscle control. By recording electroencephalographic (EEG) signals or brain waves from the scalp and then decoding them, the Wadsworth BCI allows people to make selections on a computer screen [i] In this study we will be investigating the feasibility of using EEG-based Brain-Computer Interface technology as a communication solution for individuals with ALS. The specific question addressed will be: Can individuals with ALS use the BCI for communication when they present with extreme loss of neuromuscular control and severe communication impairments? The goal of the project is to determine whether this device is a practical and realistic means for individuals with ALS to communicate. The study is intended to evaluate both the complexity of the system and the degree to which each participant will be able to communicate. Trials will consist of asking the subject to follow a series of simple instructions and complete certain tasks while using the BCI.~This study design requires that the individual live in the Philadelphia region. Please contact the Wadsworth Center of the New York State Department of Health and State University of New York at Albany directly if you reside outside of this area.
Inclusion criteria: inclusion criteria:

 Medical Subjects:

 Be able to give consent themselves or via a legally authorized representative.

 Diagnosed with a neuromuscular disease and have limited ability to communicate.

 Be able to see visual cues such as targets or letters presented on the screen, and/or ability to hear auditory cues such as tones or words presented through speakers or earphones.

 Be able to understand and remember instructions concerning participation.

 Healthy control subjects:

 Be able to consent to give consent themselves or via a legally authorized representative.

 Be able to see visual cues such as targets or letters presented on the screen, and/or ability to hear auditory cues such as tones or words presented through speakers or earphones.

 Be able to understand and remember instructions concerning participation.

Exclusion criteria: :

 Individuals with cognitive impairments that would impact their ability to follow the instructions

['Amyotrophic Lateral Sclerosis', 'Neurodegenerative Disease', 'Motor Neuron Disease']

Amyotrophic Lateral Sclerosis
Neurodegenerative Disease
Motor Neuron Disease


Promoting Healthy Weight Gain During Pregnancy

Summary: Study goal is to determine whether behavioral lifestyle intervention during pregnancy can reduce the number of women who exceed the Institute of Medicine recommendations for weight gain during pregnancy.~It is hypothesized that the intervention will reduce the number of women who exceed weight gain guidelines relative to standard care. The investigators also expect the intervention to reduce the proportion of women exceeding weight gain guidelines in both normal weight and overweight groups.
Inclusion criteria: inclusion criteria:

 non-smoking, adults,

 < 16 weeks gestation

Exclusion criteria: :

 medical comorbidities


Use of Hypertonic Saline After Damage Control Laparotomy to Improve Early Primary Fascial Closure

Summary: Damage control laparotomy (DCL) has proven to be a successful means to improve survival in severely injured patients.1-5 However, the consequences of not being able to close the fascia after the initial operation due to significant resuscitation leading to bowel and retroperitoneal edema, abdominal compartment syndrome, and continued acidosis, coagulopathy and hypethermia6-7 has led to a new challenge. Delays in primary fascial closure (PFC) contributes to increased fluid losses and nutritional demands,8-9 abdominal wall hernias, enterocutaneous fistula, and intra-abdominal infections.10-13 Hypertonic saline (HTS) use after DCL has been suggested to reduce bowel edema and resuscitation volumes, thus allowing for a quicker time to closure.14 Investigators will randomize patients to receiving HTS or standard crystalloid solutions after DCL and compare the time to PFC, rate of successful closure, and rate of complications associated with an open abdomen. The current failure rate of PFC after DCL is approximately 25%. Investigators believe they can improve PFC rates using hypertonic saline.
Inclusion criteria: inclusion criteria:

 All admissions of trauma patients who sustain trauma necessitating damage control laparotomy.

 Male and female patients 18 years or older.

Exclusion criteria: :

 Children (<18 years old), prisoners, or pregnant patients.

 Patients who have more than 1/3 loss of abdominal wall due to trauma.

 Patients with baseline serum sodium of <120 mEq/L or >155 mEq/L.

['Primary Fascial Closure', 'wound vac dressing application']

Primary Fascial Closure
wound vac dressing application

['Open Abdomen After Damage Control Laparotomy']


A Randomized, Controlled Trial of Autologous Platelet Gel Treatment in Diabetic Foot Ulcers

Summary: Foot ulcers represent a significant common complication in patients with diabetes. Wound healing is a challenge. Some wounds do not respond to the best practices in wound care. Considerable effort has been directed at therapies to improve the rate of healing.~There are a variety of growth factors which have been used to stimulate wound healing. Human platelets are an autologous source of growth factors which probably can stimulate healing. Autologous platelet gel (APG) is prepared by centrifugation of autologous human whole blood. APG is rich in platelet growth factors. This study will investigate the potential improvement in wound healing with this material in diabetic foot ulcers.~This study will compare the use of autologous platelet gel ( study group) and standard care ( control group) in the treatment of diabetic plantar forefoot ulcers. This study will also compare the cost and quality of life in the two groups.~Objectives of the study:~To determine if topical APG (autologous platelet gel) is beneficial in the treatment of diabetic foot ulcers.~To determine if it will result in a faster rate of wound healing.~To determine if it will improve the quality of life in patients with diabetic foot ulcers.
Inclusion criteria: inclusion criteria:

 Patient is greater than 18 years of age

 Patient has Type I or Type II Diabetes

 Patient must be able to understand English (self or translator) and give written, informed consent

 Patient has a plantar forefoot ulcer(s) beneath metatarsal head or toe ulcer which has been present for at least 4 weeks, and has received best practice care

 Evidence of adequate arterial perfusion: Toe plethysmography reading of

 45 mmHg or Transcutaneous oxygen measurement of ≥ 30mmHg

 Patient is appropriately offloaded (contact cast, pneumatic walking cast)

 Infection and/or osteomyelitis have been ruled out or are being treated

 Patients must have a platelet count greater than150,000/mm3

 Orthopedic assessment has been completed to rule out mechanical source of ulceration

 Patients with following skeletal deformities could be included -

 Tendoachillis contracture - after tendoachillis contracture lengthening has been done

 Charcot arthropathy with concurrent surgical intervention

 Toe deformities ( hallus valgus, significant claw toe deformities) with/after surgical intervention

 Major axial malalignment (hindfoot varus/valgas, pes planus, pes cavus) with/after surgical intervention

 Patients taking clopidogrel (Plavix) and aspirin could be included in the study. Patients taking aspirin for non medical reason will be asked to discontinue the medicine one week before the start of treatment.

Exclusion criteria: :

 TcPO2 <30 mmHg and/or toe plethysmography readings of less then 45 mmHg

 Limb ischemia requiring re-vascularization or impending amputation

 Untreated wound infection or osteomyelitis

 Bleeding disorders, hemophilia, sickle cell disease, thrombocytopenia,and leukemia or blood dyscrasias

 Anemia with hemoglobin level less than 100 g/L will be included as


Genetic Mapping for Cardiac Risk Assessment

Summary: The main objective of the GENOCOR project (Genetic mapping for cardiac risk assessment) is the setting up of a joint public/private laboratory (GENOCOR-LAB) dedicated to the development and testing of new cost-effective technologies exploiting the growing knowledge in the genomic correlates of cardiovascular diseases (CVD) and of their evolution; the data obtained by the GENOCOR-Lab should especially orient secondary prevention and specific treatment of ischemic heart diseases (IHD).
Inclusion criteria: inclusion criteria:

 Patients affected by history of IHD with a non-fatal evolution(angina or AMI as first manifestation),age at the onset of the disease (<50 o >60 years.

 Patients with acute coronary syndrome as first manifestation of coronary disease, admitted to the coronary unit within 6 hours from the onset of symptoms.

Exclusion criteria: :

 Age>75

 Pregnancy

 Recent(< 6 months) cerebral ischemic attack

 Active cancer

 Inability to provide an informed consent.

['Angina Pectoris', 'Myocardial Infarction', 'Coronary Disease', 'Myocardial Ischemia', 'Acute Coronary Syndrome']

Angina Pectoris
Myocardial Infarction
Coronary Disease
Myocardial Ischemia
Acute Coronary Syndrome


The Effect of Early Versus Traditional Follow-Up on Breastfeeding Rates at 6 Months

Summary: The study's purpose is to determine if early (2-3 week) versus traditional (6-8 week) postpartum follow up is associated with a higher rate of breastfeeding at 6 months. The study's hypothesis is that follow up at 2-3 weeks postpartum is associated with a higher rate of breastfeeding 6 months postpartum.
Inclusion criteria: inclusion criteria:

 Age 18 or above at time of delivery

 Delivery of live born infant at estimated gestational age (EGA) ≥37wk

 Postpartum primiparous patients within the first 48 hours after delivery

 Patient intent to breastfeed

 Breastfeeding initiated within the first 48 hours of delivery and/or prior to hospital discharge (whichever occurs first)

 Infant is continuously rooming in with mother from the time of delivery

 English-speaking

 Able to read and complete surveys

 No anticipated discharge from military system, Tricare benefits, or move planned in the upcoming 6 months

 Willing to render informed consent

Exclusion criteria: :

 Patients delivered by the Family Medicine Department (relatively small number in our population who are not followed postpartum by the Department of Obstetrics and Gynecology)

 Any condition deemed by patient provider to be an absolute contraindication to breastfeeding

 Maternal HIV/AIDS

 Planned use of radioactive or chemotherapeutic medications or medication for other medical problems which is contraindicated for delivery

 Known fetal factor that would impair breastfeeding

 Fetal mid-facial defects

 Known fetal chromosomal abnormality

 Known fetal conditioning resulting in fetal hypotonia

 Labor and Delivery complications

 Maternal separation from infant during the first 48 hours postpartum (such as maternal ICU admission, infant NICU admission)

['Postpartum follow up appointment 2-3 weeks after delivery', 'Postpartum follow up 6-8wk after delivery']

['Pregnancy', 'Breastfeeding', 'Contraception', 'Cervical Cancer', 'Postpartum Depression']

Pregnancy
Breastfeeding
Contraception
Cervical Cancer
Postpartum Depression


The Watch the Spot Trial

Summary: This study will compare two clinically accepted protocols for surveillance imaging in individuals who are found to have a small pulmonary nodule on chest computed tomography (CT) scans.
Inclusion criteria: inclusion criteria:

 The target population includes adults with small lung nodules that may represent a new diagnosis of lung cancer, who typically would be managed by CT surveillance in usual clinical practice. Thus, we will enroll all patients:

 aged ≥35 years

 at least one nodule measuring ≤15 mm in average diameter on chest CT.

Exclusion criteria: :

 Pregnant Women

 Age <35 years

 Known diagnosis of cancer (except non-melanoma skin cancer) within 5 years

['More Frequent Surveillance Strategy', 'Less Frequent Surveillance Strategy']

More Frequent Surveillance Strategy
Less Frequent Surveillance Strategy

['Solitary Pulmonary Nodule', 'Coin Lesion, Pulmonary', 'Lung Neoplasms', 'Carcinoma, Non-small-cell Lung']

Solitary Pulmonary Nodule
Coin Lesion
Pulmonary
Lung Neoplasms
Carcinoma
Non-small-cell Lung


China Clinical Trial for Therapeutic MR-HIFU Ablation of Uterine Fibroids

Summary: The purpose of this study is to demonstrate safety and effectiveness of the Philips Sonalleve Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) for treatment of uterine fibroids in a Chinese population.
Inclusion criteria: inclusion criteria:

 Women, age between 18 and 55 years

 Weight < 140 kg

 Pre- or peri-menopausal

 Uterine size < 24 weeks

 Cervical cell assessment by Pap smear/Thin-prep Cytologic Test (TCT): Normal, Low Grade Squamous Intraepithelial Lesion (SIL), Low risk Human Papillomavirus (HPV) or Atypical Squamous Cells of Uncertain Significance (ASCUS) subtypes of cervical tissue

 Fibroids selected for treatment meeting the following criteria:

 Total planned ablation volume of all fibroids should not exceed 250 ml, and

 No more than 5 fibroids should be planned for ablation, and

 Dominant fibroid (diameter) is greater than or equal to 3 cm, and

 Fibroids which are completely non-enhancing under Magnetic Resonance (MR) contrast agent should not be treated as the identification of treated volume becomes ambiguous

 Highly perfused or brighter than myometrium in T2-weighted MRI (according to the T2 contrast obtained using the Philips MR-HIFU protocol) fibroids should not be treated

 MR-HIFU device accessibility to fibroids such that at least 50% of the total fibroid volume can be treated

 Willing and able to attend all study visits

Exclusion criteria: :

 Other pelvic disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis)

 Desire for future pregnancy

 Significant systemic disease, even if controlled

 Positive pregnancy test

 Hematocrit < 25%

 Extensive scarring along anterior lower abdominal wall (> 50% of area)

 Surgical clips in the direct path of the HIFU beam

 MRI contraindicated

 MRI contrast agent contraindicated

 Fibroids not quantifiable on MRI (e.g. multi-fibroid cases where volume measurements are not feasible)

 Calcifications around or throughout uterine tissues

 Communication barrier

 Suspected malignancy


Impact of Anti-inflammatory and Antibiotic Therapy on the Emergence of Peri-tonsillar Abscess

Summary: Analyze in children and adults, risk factors in the onset of the APA. The main hypothesis focuses on the use of anti-inflammatory in the context of pharyngitis or sore throat before the symptoms of ABS. Secondary objectives:~- Analyze the implementation of a rapid diagnostic test and its result on the occurrence of an ABS~- Measure the frequency of prescription and describe the reasons for not prescribing an antibiotic for patients who consulted for a sore throat and having developed a PLA~- Describe the microbial flora could puncture of patients hospitalized for APA
Inclusion criteria: inclusion criteria:

 clinical existence of a PLA (phlegmon), validated by a senior ENT, usually (but not necessarily) following a request by an emergency. The visible appearance to the merits throat must justify puncture. Cases will be included whether or not they had consulted for a sore throat in the 10 days preceding the date of diagnosis

Exclusion criteria: :

 Neoplastic disease of the throat, scalable Hematologic with tonsillar localization History of tonsillectomy


Preconditioning Shields Against Vascular Events in Surgery

Summary: Major vascular surgery involves operations to repair swollen blood vessels, clear debris from blocked arteries or bypass blocked blood vessels. Patients with these problems are a high-risk surgical group as they have generalized blood vessel disease. These puts them at risk of major complications around the time of surgery such as heart attacks , strokes and death. The mortality following repair of a swollen main artery in the abdomen is about 1 in 20. This contrasts poorly with the 1 per 100 risk of death following a heart bypass. Simple and cost-effective methods are needed to reduce the risks of major vascular surgery. Remote ischaemic preconditioning (RIPC) may be such a technique. To induce RIPC, the blood supply to muscle in the patient's arm is interrupted for about 5 minutes. It is then restored for a further five minutes. This cycle is repeated three more times. The blood supply is interrupted simply by inflating a blood pressure cuff to maximum pressure. This repeated brief interruption of the muscular blood supply sends signals to critical organs such as the brain and heart, which are rendered temporarily resistant to damage from reduced blood supply. Several small randomized clinical trials in patients undergoing different types of major vascular surgery have demonstrated a potential benefit. This large, multi-centre trial aims to determine whether RIPC can reduce complications in routine practice.
Inclusion criteria: inclusion criteria:

 Age greater than 18 years

 Patient willing to give full informed consent for participation

 Patients undergoing elective carotid endarterectomy or

 Patients undergoing open abdominal aortic aneurysm repair or

 Patients undergoing endovascular abdominal aneurysm repair or

 Patients undergoing surgical lower limb revascularisation (suprainguinal or infrainguinal)

Exclusion criteria: :

 Pregnancy

 Significant upper limb peripheral arterial disease

 Previous history of upper limb deep vein thrombosis

 Patients on glibenclamide or nicorandil (these medications may interfere with RIPC) Patients with an estimated pre-operative glomerular filtration rate < 30mls/min/1.73m2

 Patients with a known history of myocarditis, pericarditis or amyloidosis

 Patients with an estimated pre-operative glomerular filtration rate < 30mls/min/1.73m2.

 Patients with severe hepatic disease defined as an international normalised ratio >2 in the absence of systemic anticoagulation

 Patients with severe respiratory disease (for the trial, defined as patients requiring home oxygen therapy)

 Patients previously enrolled in the trial representing for a further procedure

 Patients with previous axillary surgery

['Abdominal Aortic Aneurysm', 'Carotid Atherosclerosis', 'Critical Lower Limb Ischaemia']

Abdominal Aortic Aneurysm
Carotid Atherosclerosis
Critical Lower Limb Ischaemia


Hypothermia in Children After Trauma

Summary: The primary hypothesis for this application for a multicenter phase III randomized clinical trial (RCT) is that induced moderate hypothermia (HYPO) (32-33 °C) after severe traumatic brain injury (TBI) in children and maintained for 48 hours will improve mortality at 3 months and 12 month functional outcome as assessed by the Glasgow Outcome Scale (GOS).
Inclusion criteria: inclusion criteria:

 Patients with a GCS </= 8

 Glasgow Motor Score < 6

 Closed head injury

 Age 0 < 18 y

Exclusion criteria:

 Unavailable to initiate cooling within 6 hours of injury

 Glasgow Coma Scale (GCS) score = 3 and abnormal brainstem function

 Normal initial CT scan (No blood, fracture, swelling, and/or shift)

 Penetrating brain injury

 No known mechanism of injury

 Unknown time of injury

 Uncorrectable coagulopathy (PT/PTT > 16/40 sec, INR > 1.7)

 Hypotensive episode (Systolic Blood Pressure <5th percentile for age>10 min)

 Documented Hypoxic episode (O2 saturation < 94% for > 30 min)

 Pregnancy


Pharmacokinetics of Zolpidem Orodispersible Tablet

Summary: This is a Phase I, open-label, randomized trial to evaluate the single-dose pharmacokinetics of Zolpidem orodispersible tablet at two different dosages (1.75 mg and 3.50 mg). Sample size is 48 participants, male or female, aged above 18 years-old.~Primary objective is to evaluate pharmacokinetics of Zolpidem orodispersible tablet at two different dosages (1.75 mg and 3.50 mg), and secondary objective is to evaluate safety and tolerability of the investigational product.~Participants will be admitted for a period of 36 hours, when investigational product will be administered, and blood samples, at pre-determined time periods, will be collected for pharmacokinetics.~Primary endpoint is to obtain pharmacokinetics parameters. Additionally, safety will be assessed by adverse events occurrence and laboratory exams evaluation.
Inclusion criteria: inclusion criteria:

 Male or female study participants, aged above 18 years-old; women cannot be pregnant or breastfeeding

 Body mass index (BMI) greater than or equal to 19 and less than or equal to 28.75 Kg/m2

 Good health conditions or without significant diseases, according to best medical judgement, according to protocol requirements and study evaluations: medical history, blood pressure and heart rate measurements, physical examination, electrocardiogram (ECG) and complementary laboratory tests

 Ability to understand the nature and objectives of the trial, including risks and adverse events; willingness to cooperate with the researcher and proceed according to all study requirements, which shall be confirmed by Informed Consent Form signature.

Exclusion criteria: :

 Known hypersensitivity to the investigational product (Zolpidem) or chemically related compounds; history of serious adverse reactions or hypersensitivity to any drug

 History or presence of hepatic or gastrointestinal diseases, or other condition that interferes with drug absorption, distribution, excretion or metabolism

 Chronic therapy with any drugs, except oral contraceptives

 History of hepatic, kidney, lungs, gastrointestinal, epileptic, hematologic or psychiatric disease; hypotension or hypertension, of any etiology, that requires pharmacological treatment; history of myocardial infarction, angina and/or heart failure

 Electrocardiographic findings that, at investigator criteria, are not recommended for study participation

 Deviations on screening laboratory results that are considered as clinically relevant by the researcher

 Smoking

 Intake of more that 5 cups of coffee or tea per day

 Unusual food habits, e.g., vegetarians

 History of drugs and alcohol addiction or excessive alcohol consumption (> 35 g/day)

 Use of regular medications within 2 weeks prior study enrollment or use of any medications within one week prior to study enrollment, except oral contraceptives or cases which, based on drug's or metabolite's half-life, complete elimination can be assumed

 Hospitalization for any reasons up to 8 weeks before trial

 Treatment, within 6 months before the trial, with any drugs with known and well-established toxic potential to major organs

 Participation in any other experimental research or administration of any experimental drug within 6 months before this trial

 Donation or loss of 450 mL or more of blood within 3 months before this trial or 3 donations (women)/4 donations (men) of blood within 12 months before this trial

 Any condition, according to investigator's best judgement, that prevents the subject to participate in the trial

 Pregnancy, labor or miscarriage with 12 weeks before admission predicted date.


The Impact of Material on Microbiota in Association With Tongue and Lip Piercing

Summary: Biofilms on oral piercings may serve as a bacterial reservoir and lead to systemic bacteraemia or local transmission of periopathogenic microbiota.~The investigators hypothesize that there are microbiological differences in bacterial samples collected from tongue /or lip piercings made of different materials. The investigators also hypothesize that the piercings carry the same characteristic bacteria as found in the piercing channels and that independently the biofilm on the tongue/adjacent teeth is similar to the other study locations.~85 subjects with tongue and 85 subjects with lip piercing will participate. Periodontal clinical parameters, traumata of hard tissues, and characteristics of the stud are evaluated. Sterile piercings of four different materials will be randomly allocated to the study subjects. After two weeks, microbiologic samples are collected and are processed by checkerboard DNA-DNA hybridization methods.
Inclusion criteria: inclusion criteria:

 lip/tongue piercing for at least six month in situ

Exclusion criteria: :

 pregnancy and lactating women

 medication with known effects on gingival tissues

 antibiotic medication in the last six months or need for antibiotic prophylaxis

 chlorhexidine use in the last six months

 non-plaque induced gingival disease

 prior diagnosis of periodontitis

['piercings of four different materials']


Financial Incentives for Maintenance of Weight Loss

Summary: This study aims to evaluate the effectiveness of financial incentives in improving and maintaining weight loss.
Inclusion criteria: inclusion criteria:

 Adults age 30-80

 BMI between 30 and 45 prior to starting Weight Watchers

 Have a documented weight loss of at least 5kg in the past 4-6 months before enrolling

 Stable health

Exclusion criteria: :

 Substance abuse

 Bulimia nervosa or related behaviors

 Pregnancy or breast feeding

 Medical contraindications to counseling about diet, physical activity, or weight reduction

 Unstable mental illness

 Screen positive for pathological gambling on the basis of the 10 item DSM-IV criteria (excluded if meets 5 or more criteria)

 Individuals unable to read consent forms or fill out surveys in English


Summary: A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention
Inclusion criteria: inclusion criteria

 Subjects who meet the following criteria may be included in the clinical investigation, if they present with ALL of the following:

 Subject is able to understand the evaluation and willing to consent and comply with all post-debridement visits and procedures

 Age 18 years and older. Subjects may be of either sex and of any race or skin type

 Subjects fulfilling any one or all of the following criteria:

 chronic wound(s) below the level of the knee, defined by delayed healing or cellular senescence

 acute wound(s) as a result of a surgical procedure, laceration, abrasion or trauma

 diabetic foot ulcer(s)

 subjects with venous leg ulcers below the knee on the leg or foot with one or more documented failure of maximal medical therapy for their study wound >30 days such as compression bandages (low elasticity, elastic, multilayered, elastic and non elastic compression)

 Subjects with the following lab results within 30 days of treatment:

 serum albumin level >20g/L

 clinically non significant results of liver function test (LFTs), serum glucose and complete blood count (CBC) with differential

 Subjects with a Braden Score ≥13-14 (Moderate Risk)

 Subjects with adequate arterial blood flow [Ankle-Brachial Index (ABI) >0.75]

Exclusion criteria:

 Subjects will be excluded from the clinical investigation, if they present with ANY of the following:

 Subjects that have tunneling wounds

 Subject presents with an active infection in the study wound, as defined by purulence and:

 Fever and leukocytosis

 OR any TWO of the following:

 Malodor, pain or tenderness, warmth, erythema, induration, swelling, lymphangitis

 Infected bone diagnosed by imaging modality (e.g., Magnetic Resonance Imaging (MRI) and/or radiographic images)

 Subjects whose study wound does not require debridement

 Cardiac pacemaker or other electronic implant(s)

 Subjects with irradiate, burn or ischaemic wounds or history of keloids

 Subjects with vasculitis, non-reconstructive peripheral vascular disease, pyoderma gangrenosum, renal failure or lymphoedema

 Subjects with uncontrolled bleeding disorder (PT/PTT) and coagulopathy (including those with hemophilia)

 Subjects taking treatment with any of the following:

 Systemic corticosteroids

 Immunosuppressive agent(s)

 Chemotherapy or Radiation therapy

 Subjects deemed to require biologic dressing/ skin substitute

 Terminally ill subjects

 Subjects that have an immunodeficiency disorder that interferes with wound healing, including Acquired Immunodeficiency Syndrome (AIDS) or know to be infected with Human Immunodeficiency Virus (HIV)

 Subjects that have chronic skin conditions such as psoriasis, etc.

 Subjects that reside in a nursing home

 Subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.) to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant

 Subject is pregnant and/or intending to become pregnant during this clinical investigation period

 Subject has documented evidence of a history (e.g. liver testing) of drug/alcohol abuse within the 12 months prior to enrollment for clinical investigation entry

 Subject is excluded if they have received an investigational therapy or approved therapy for investigational use within 30 days of surgery

 Subject is excluded if planning to participate in another research study during the follow-up phase of this study or 84 days after study completion

['WoundWand™ Debridement Device', 'Standard of Care sharp debridement']

WoundWand™ Debridement Device
Standard of Care sharp debridement


ATCF (Azole Therapy in Cystic Fibrosis)

Summary: Aspergillus infection is an infectious complication which frequently occurs in cystic fibrosis. The efficacy of azole therapy in patients with cystic fibrosis with persistent positive sputums for Aspergillus is still unknown. Furthermore, the efficacy of itraconazole and voriconazole in this indication has never been evaluated in a large prospective controlled clinical trial, even though many teams already use it. The ATCF study aims to assess in patients with cystic fibrosis with persistent Aspergillus positive cultures the efficacy of itraconazole and voriconazole on the negativisation of the sputum cultures for Aspergillus.
Inclusion criteria: inclusion criteria:

 Patient with cystic fibrosis,

 men or women,

 age equal greater to 12 years,

 presenting with a positive sputum culture for Aspergillus confirmed twice within 6 months before study entry and at initial visit,

 written informed consent.

Exclusion criteria: :

 patients with a contraindication to one of the antifungal agents evaluated,

 pregnant women or nursing mothers,

 absence of an effective method of contraception in women of child-bearing potential,

 patients with signs or symptoms of invasive aspergillosis,

 patients with signs or symptoms of aspergilloma,

 patients with an infection caused by Burkholderia complex Cepacia or to mycobacteria,

 lung transplant patients, registered on a transplantation waiting list or whose registration is imminent,

 patients who received systemic antifungal therapy for more than 5 days within 2 months prior to inclusion,

 patients currently enrolled in another clinical drug trial,

 ongoing treatment with medicinal products contraindicated with itraconazole and voriconazole or with major interactions which reduce azole concentrations,

 patients treated by medication known to prolong QT interval, or with known prolongation of QTc interval > 450 msec in men and > 470 msec in women,

 Inability to follow or to understand the study procedures.

['Cystic Fibrosis', 'Aspergillus Infections']


Re-differentiation of Radioiodine-Refractory BRAF V600E-mutant Papillary Thyroid Carcinoma With GSK2118436

Summary: Radioactive iodine therapy is often part of the standard treatment for Papillary Thyroid Carcinoma (PTC) patients. However, in many patients, tumors develop a resistance or no longer respond to radioactive iodine therapy (iodine-refractory). Several lines of evidence suggest that blocking the BRAF gene may help to re-sensitize the tumors to radioactive iodine. BRAF is a protein that plays a central role in the growth and survival of cancer cells in some types of PTC. The investigational drug GSK2118436 may work by blocking the BRAF protein in cancer cells lines and tumors that have a mutated BRAF gene.~In this research study, the investigators are looking to see if GSK2118436 can re-sensitize iodine-refractory PTC to radioactive iodine therapy. The investigators are also looking at the safety of adding GSK2118436 to radioactive iodine therapy.
Inclusion criteria: inclusion criteria:

 Histologically confirmed papillary thyroid carcinoma, including its variants, such as tall cell PTC or poorly differentiated thyroid carcinoma, that is metastatic or unresectable AND harbors a BRAF V600E mutation

 Evaluable disease, as defined by at least one lesion that can be accurately measured in at least one dimension on CT scan or ultrasound, if present in the neck

 Radioiodine-refractory disease

 Life expectancy > 6 months

 Able to swallow and retain oral medication

 Normal organ and marrow function

Exclusion criteria: :

 Pregnant or breastfeeding

 Previous treatment with a specific BRAF or MEK inhibitor

 Receiving any other study agents

 Known brain metastases

 History of allergic reactions attributed to compounds of similar chemical or biologic composition to GSK2118436, bovine TSH, mannitol or iodine

 Active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs

 History of known glucose-6-phosphate dehyrogenase (G6PD) deficiency

 Corrected QT interval >/= 480 msecs; history of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks; Class II, III, or IV heart failure, abnormal cardiac valve morphology; or history of known cardiac arrhythmias

 Taking herbal remedies

 Subjects with significant symptoms from their thyroid cancer, or have a large burden of rapidly progressive iodine-refractory PTC who are in need of other systemic therapy, as judged by their treating physician

 Uncontrolled current illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension or psychiatric illness/social situations that would limit compliance with study requirements

 History of a different malignancy unless disease-free for at least 5 years and deemed to be at low risk for recurrence

 HIV-positive on combination antiretroviral therapy


Study of the Effect of Intramuscular Ephedrine on the Incidence of Nausea and Vomiting During Elective Cesarean Section

Summary: The purpose of this research study is to investigate if the incidence of nausea and vomiting that subjects experience during and after a Cesarean section can be reduced by giving a shot of the drug ephedrine into the thigh muscle at the time of spinal anesthesia administration.
Inclusion criteria: inclusion criteria:

 Must be pregnant with a single baby

 Must be at term in their pregnancy (estimated gestational age of at least 38 weeks)

 Must be scheduled for an elective Cesarean section

 Must be between 60-70 tall

 Must be free of severe systemic disease (ASA class I or II)

Exclusion criteria: :

 Contraindication to spinal anesthesia

 Any allergy to any of the medications included in the study

 History of pregnancy-induced hypertension or preeclampsia

 History of preexisting hypertension

 Diabetes mellitus

 Hyperemesis gravidum

 Previous perioperative nausea and vomiting

 History of motion sickness

 Women carrying a fetus with a known abnormality will also be excluded from the study

['Ephedrine [Synonyms: Ephedra, Ephedrinum]', 'Saline Placebo']

Ephedrine [Synonyms: Ephedra
Ephedrinum]
Saline Placebo

['Nausea', 'Vomiting', 'Cesarean Section']


Trial Comparing Simple Follow-up to Exploratory Laparotomy Plus in Principle (Hyperthermic Intraperitoneal Chemotherapy) HIPEC in Colorectal Patients

Summary: Multicentric randomised trial. Patients with a high risk of developing colorectal Peritoneal Carcinomatosis (PC) after resection of their primary will be informed, will sign the consent and will be pre-registered. All patients will receive the current standard adjuvant treatment : 6 months of systemic chemotherapy (currently the Folfox-4 regimen which could be modified if the standard is modified). Then a work-up is done to exclude recurrence. The likelihood of a recurrence is low but if this occurs, the patient will not be randomised and will be treated with the best known treatment. If the work-up is negative, patients will be randomised to surveillance alone (control group) or exploratory laparotomy + HIPEC (experimental group).
Inclusion criteria: inclusion criteria:

 A) Patients presenting with the following history:

 Histologically-proven colorectal adenocarcinoma

 Presenting at the time of resection of the primary with one of the following 4 criteria (criteria indicating a high risk of developing PC) :

 Minimal PC, resected at the same time as the primary

 Ovarian metastases

 Rupture of the primary tumour inside the peritoneal cavity,

 Iatrogenic rupture of the primary tumour during surgery

 B) Who have received standard systemic adjuvant chemotherapy (6 months of systemic chemotherapy) :

 Chemotherapy with the Folfox 4 regimen (the current standard treatment ; it can be modified in the future in the two groups, if the standard is modified…).

 Given on an intent-to-treat basis (it can be stopped prematurely for miscellaneous reasons…);

 C) Patients who do not present any sign of tumour recurrence at the end of these 6 months of chemotherapy.

 D) Patients with the following general characteristics:

 Age between 18 and 70 years,

 Performance Status WHO < 2, life expectancy > 12 weeks,

 Haematological parameters : Polynuclear neutrophils ³ 1.5x109/L, platelets ³ 100x109/L,

 Liver function : Total Bilirubin £ 1.5 x ULN, AST (SGOT) et ALT (SGPT) £ 3 x ULN, alkaline phosphatases £ 3 x ULN,

 Renal function : Plasma creatinine £ 1,25 x ULN,

 Operable patients,

 Grade £ 2 peripheral neuropathy (CTC AE v3.0 annex 7)

 Patients entitled to French National Health Insurance coverage.

 E)Patients will be informed and a signed consent form will be obtained before initiating any procedure specific to the trial.

Exclusion criteria: :

 Cancers of non colorectal origin, particularly, appendiceal cancers are excluded

 Patients presenting with a detectable recurrent tumour

 Grade ≥ 3 Peripheral neuropathy

 History of cancer (excepted cutaneous basocellullar cancer or in situ carcinoma of the uterine cervix) with a recurrence during the 5 previous years

 Patients already included in another trial concerning first-line treatment 6) Pregnant women or likely to be pregnant

 7) Persons under guardianship 8) Follow-up impossible for geographic, social or psychological reasons

['Colorectal Cancer With a Resected Minimal Synchronous PC', 'Ovarian Metastases', 'Tumour Rupture in the Abdominal Cavity']


Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With ABC

Summary: Cardiac perfusion changes have been seen after whole breast / chest wall irradiation for breast cancer. The Active Breathing Coordinator (ABC) device theoretically decreases radiation exposure to the heart during radiation for breast cancer. In this trial cardiac perfusion changes or lack thereof will be quantified in women treated with radiation for breast cancer while using the ABC device. The control group of the study will consist of patients randomized to radiation therapy without the ABC device.
Inclusion criteria: inclusion criteria:

 Patient must be 18 and older

 Patients must have histologically confirmed (by routine H&E staining) invasive adenocarcinoma or Ductal Carcinoma In Situ of the left breast.

 Patients must have undergone a segmental mastectomy (SM) or Mastectomy

 Patients must not have received prior radiation therapy to the breast at any time for any reason.

 Any patient with active local-regional disease prior to registration is not eligible.

 Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen. Women of child-bearing age will be given a serum pregnancy test prior to study entry to ensure they are not pregnant. Women of child-bearing potential must use effective non-hormonal contraception while undergoing radiation therapy.

 Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment.

 All patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines.

Exclusion criteria: :

 Patients requiring oxygen

 Sarcoma or Squamous Cell pathology

 Right-sided breast cancers

 Metastatic disease to the breast

['Breast Neoplasms', 'Carcinoma, Ductal', 'Adenocarcinoma']

Breast Neoplasms
Carcinoma
Ductal
Adenocarcinoma


Venous Thromboembolism Prophylaxis Post Cesarean Section

Summary: Pregnancy is associated with an overall 5-10 fold increased risk of venous thromboembolism (VTE). VTE remains the most common cause of maternal death in the developed world. It is up to 10 times more common in pregnant women than non-pregnant women of comparable age. More than a third of pregnancy-related VTE occurs during the six weeks after delivery. When compared with vaginal delivery, cesarean delivery further increases the risk of pregnancy associated VTE by three-fold.
Inclusion criteria: inclusion criteria:

 Age > 18 years old.

 Delivered by cesarean section (emergency or planned).

 Signed, informed consent.

 Ready access to a local health service.

 Capable of using Tinzaparin.

Exclusion criteria: :

 at high risk for thromboembolism (any one of the following):

 age more than 35 years old

 obesity (more than 80 kg)

 parity more than 4

 gross varicose veins

 current infection

 pre-eclampsia

 immobility prior to surgery (more than 4 days)

 Major current disease: including heart or lung disease, cancer,inflammatory bowel disease and nephrotic syndrome.

 Extended major pelvic or abdominal surgery (e.g. cesarean hysterectomy)

 Patients with a family history of VTE

 History of superficial phlebitis

 More than 36 hours since delivery

 Need for anticoagulation, including:

 women with a confirmed thrombophilia

 women with paralysis of lower limbs

 women with personal history of VTE

 women with antiphospholipid antibody syndrome (APLA)

 women with mechanical heart valves

 Contraindication to heparin therapy, including history of heparin induced thrombocytopenia.


Kyoto Congestive Heart Failure Study

Summary: The purpose of this study is to investigate the patient characteristics, selection of treatment, and factors associated with clinical outcomes in Japanese patients with acutely decompensated congestive heart failure.
Inclusion criteria: inclusion criteria:

 All patients who admitted to the participating centers due to acutly decompensated CHF defined by modified Framingham criteria

 Patients who underwent heart failure treatment including intravenus drug

Exclusion criteria: :

 none

['Congestive Heart Failure', 'Heart Failure, Diastolic', 'Heart Failure, Systolic', 'Elderly Frail', 'Guideline Adherence']

Congestive Heart Failure
Heart Failure
Diastolic
Heart Failure
Systolic
Elderly Frail
Guideline Adherence


Long Term Extension Study Evaluating Safety, Tolerability And Immunogenicity Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease

Summary: The purpose of this long term extension study is to assess safety, tolerability and immunogenicity of ACC-001 with QS-21 adjuvant in Japanese subjects with mild to moderate AD who were randomized in the preceding P2 double blind studies.
Inclusion criteria: inclusion criteria:

 Subjects randomized under previous 3134K1-2202-JA (NCT00752232) and 3134K1-2206-JA (NCT00959192) and met all inclusion criteria and non of the
Exclusion criteria: .

 Screening brain MRI scan is consistent with the diagnosis of AD.

 MMSE score 10 and above.


Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children

Summary: The objective of this study is to assess the immunogenicity, safety and interchangeability of two different TBE vaccines in children aged 1-11 years, the first and second vaccination with either FSME-IMMUN 0.25ml Junior or Encepur 0.25ml Children and the third vaccination with FSME-IMMUN 0.25 ml Junior only, administered according to the conventional schedule (0, 28 and 360 days).
Inclusion criteria: inclusion criteria:

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

 they are aged >= 1 years (from the 1st birthday) to 11 years (to the last day before the 12th birthday) at screening;

 their parents / legal guardians provide written informed consent;

 children provide written assent to the study according to age and capacity of understanding;

 their parents/guardians understand the nature of the clinical study and will comply with the requirements of the protocol (e.g., completion of the Subject Diary, return for follow-up visits);

 they are generally healthy, (i.e. the physician would have no reservations vaccinating with a TBE vaccine outside the scope of a clinical study);

 provide a negative pregnancy test result at the first medical examination (if the subject is a female and capable of bearing children).

Exclusion criteria: :

 Subjects will be excluded from participation if:

 they have a history of any previous TBE vaccination;

 they have a history of TBE infection;

 they have a history of infection with other flaviviruses;

 they have a history of vaccination against yellow fever and/or Japanese B encephalitis;

 they have a history of severe allergic reactions, in particular a known sensitivity or allergy to any components of the vaccines;

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

 they have received any blood product or immunoglobulins within 90 days prior to study entry;

 they are known to be Human Immunodeficiency Virus (HIV) positive (an HIV test is not required specifically for the purpose of this study);

 they have a functional or surgical asplenia;

 they have a rash or other dermatological condition at the injection site which could interfere with injection site reaction evaluation;

 they were administered an investigational product within six weeks prior to study start or are concurrently participating in another clinical study that includes the administration of an investigational product;

 they are pregnant or breastfeeding (if a female subject);

 they or their parents/legal guardian(s) are in a dependent relationship with the study investigator or with a study team member. Dependent relationship includes close relatives (i.e., children or grandchildren, partner/spouse, siblings) as well as employees of the investigator or site conducting the study.

 Subjects who have an acute illness with or without elevated body temperature (>=37.5°C) within 3 days prior to the scheduled first vaccination will not be vaccinated. Subjects may be included at a repeat visit provided that (1) the illness has resolved (body temperature < 37.5 °C), (2) the repeat visit is no more than 14 calendar days after the Screening Visit, and (3) the center is still open for recruitment.

 If subjects have received antipyretics within 4 hours prior to the scheduled time of vaccination, the vaccination should be performed at a later date, as long as the center is still open for recruitment.

 Subjects who received any live vaccine within 4 weeks or any inactivated vaccine within 2 weeks prior to the scheduled first study vaccination will not be vaccinated until an interval of 4 or 2 weeks, respectively, has passed, provided the center is still open for recruitment.

 If a subject was bitten by a tick within 4 weeks prior to the scheduled first or second vaccination, the vaccination must be postponed until an interval of 4 weeks has passed.

['Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)', 'Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)']


Risk of Uncomplicated Peptic Ulcer in the General Population

Summary: The analyses are conducted in a previous population-based cohort study using The Health Improvement Network database in the UK (Cai et al 2009).The aims of the post hoc analyses are:~To estimate the relative risk of uncomplicated symptomatic peptic ulcer (UPU) associated with use of low dose aspirin (ASA) and other anti-inflammatory drugs (NSAIDs, steroids) in the general population To estimate the dose-response and duration-response associated with use of these drugs To estimate the relative risk of UPU associated with naive/non-naive use of low dose ASA in the general population To evaluate the effect of proton pump inhibitors (PPI) (alone or in combination with anti-inflammatory drugs) on the occurrence of UPU in the general population To investigate the management of low dose ASA/oral antiplatelets after UPU
Inclusion criteria: inclusion criteria:

 - Patients aged 40-84 years in 1997-2005 ( see study population description)

Exclusion criteria: :

 - Patients aged below age 40 and 85 years and above ( see study population description)

['Peptic Ulcer [Iowa Type (107680.0010)]']


Multiple Oral Administration of ASP7991 to Non-elderly Male Subjects

Summary: This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after multiple oral administrations to non-elderly subjects.
Inclusion criteria: inclusion criteria:

 Healthy, as judged by the investigator/sub investigator based on the results of physical examination obtained before study drug administration

 Body weight: ≥50.0 kg, <80.0 kg

 BMI: ≥17.6, <26.4

 Serum corrected calcium concentration: ≥9.0mg/dL, <10.4 mg/dL

Exclusion criteria: :

 Received any investigational drugs in other clinical or post-marketing studies within 120 days before screening

 Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before screening

 Received medication (including marketed drug) within 7 days before hospitalization, vitamin preparation including vitamin D and supplement including calcium or is scheduled to receive medication

 A deviation from normal criteria range of 12-lead ECG (QT evaluation)

 A deviation from the normal range in clinical laboratory tests

 Highly sensitive cardiac troponin T (at screening): ≥0.014 ng/mL

 History of drug allergies

 Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before admission

 Concurrent or previous hepatic disease (e.g., viral hepatitis, drug-induced liver injury)

 Concurrent or previous endocrine disorders (e.g., hyperthyroidism, aberration in growth hormone)

['Healthy', 'Pharmacokinetics of ASP7991']


A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of Azithromycin SR Versus Amoxicillin For The Treatment Of Strep Throat In Children

Summary: The objective was to determine if a single 60 mg/kg dose of azithromycin SR was as safe and effective as a 10-day regimen of amoxicillin (45 mg/kg/day, given in divided doses every 12 hours) when used to treat children with strep throat.
Inclusion criteria: inclusion criteria:

 Patients who had evidence of acute pharyngitis/tonsillitis based on erythematous pharyngeal mucosa or thick exudate covering the pharynx and tonsillar area, and at least one of the following signs or symptoms were included: sore/scratchy throat; pain on swallowing; chills and/or fever cervical adenopathy; scarlet fever rash on the face and skin folds, or red tongue with prominent papillae (strawberry tongue). Subjects were required to have a positive rapid antigen detection test (RADT) or a positive culture of the pharynx or tonsils for GABHS.

Exclusion criteria: :

 Patients were excluded if they had previously diagnosed disease(s) of immune function or treatment with any systemic antibiotic within the previous 7 days.


ExAblate (Magnetic Resonance-guided Focused Ultrasound Surgery) for Treatment of Tremor

Summary: A feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Tremor
Inclusion criteria: inclusion criteria:

 Men and women, between 18 and 80 years, inclusive

 Patients who are able and willing to give consent and able to attend all study visits

 A diagnosis of ET as confirmed from clinical history and examination by a movement disorder neurologist

 Tremor refractory to adequate trials of at least two medications, one of which should be either propranolol or primidone. An adequate medication trial is defined as a therapeutic dose of each medication or the development of side effects as the medication dose is titrated.

 Vim nucleus of thalamus can be target by the ExAblate device. The Vim region of the thalamus must be apparent on MRI such that targeting can be performed with either direct visualization or by measurement from a line connecting the anterior and posterior commissures of the brain.

 Able to communicate sensations during the ExAblate MRgFUS treatment

 Postural or intention tremor severity score of greater than or equal to 2 in the dominant hand/arm as measured by the CRST rating scale.

 Stable doses of all medications for 30 days prior to study entry and for the duration of the study.

 May have bilateral appendicular tremor

 Significant disability due to essential tremor despite medical treatment (CRST score of 2 or above in any one of the items 16-23 from the Disability subsection of the CRST: [speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social activities])

 Inclusion and
Exclusion criteria:  have been agreed upon by two members of the medical team.


Effect of Experience on Driving Performance in New Teenage Drivers

Summary: This study will evaluate the driving performance of new teenage drivers and determine to what extent independent driving experience improves driving performance of young drivers. Motor vehicle crash rates are highest among new teen drivers, especially during the first 6 months and 1,000 miles of independent licensed driving. Crash rates decline with experience, and this study will assess the effect of driving experience on performance.~Newly licensed teenagers ranging from 16 years, 3 months to 17 years of age and experienced drivers 30 to 50 years of age may be eligible for this study. Candidates must be able to legally drive in the commonwealth of Virginia and have at least 20/40 correctable vision.~Participants complete a questionnaire about their health and driving experience. They are then tested on a driving test track. Teens are tested within 3 weeks of obtaining their driver's license and before they have more than 100 miles of independent driving experience. They are tested a second time 6 to 12 months later and after they have more than 1,000 miles of driving experience. A group of experienced adult drivers are also tested to provide a comparison.~The driving test is conducted on a smart road - a controlled, 2.2-mile two-lane research track at the Virginia Tech Transportation Institute. It is designed for safety, with restricted access, nothing for a vehicle to hit, carefully placed guardrails, and other safety features. The research vehicle is equipped with airbags, anti-lock brakes, and other safety equipment. It also has sensors and tiny video cameras to assess the behavior of the vehicle and the driver; this equipment does not interfere with the operation of the vehicle.~An experimenter accompanies the driver and instructs him or her to perform routine driving skills, such as stopping, changing lanes and maintaining speed, as well as to other tasks such as inserting a CD into an entertainment console, having a conversation, and answering a cellular telephone call. The driver has an opportunity to practice the tasks before being tested.~The driver's speed is limited to 35 mph or less during the experiment and the driver is required to wear seat belts and follow safe driving procedures. The experimenter is in the front passenger seat can stop the vehicle using a separate brake pedal.
Inclusion criteria: inclusion criteria:

 Recruitment of teen participants will occur by arrangement with local driving schools in Montgomery County, VA.

 Potential participants aged 16 or 17 who have held their driver's license for one month or less may be eligible.

 Participants may be recruited during their training, and will only be eligible after they have met all requirements for licensure, and after both parental consent and teen assent are obtained.

 If the teen wishes to participate, they must have their parent or legal guardian speak to the VTTI experimenter over the telephone for screening and then accompany the teen at an appointment so that the study can be explained and consent and assent provided.

 Experienced adult drivers will be recruited via one-page recruitment fliers describing the study posted in the Blacksburg, VA area.

 After an appointment is made, a telephone screening will occur using the Telephone Driver Screening and Demographic Questionnaire to assess age, sex, medical and driving history.
Exclusion criteria:


The Effects of Inorganic Nitrate on Cardiac Muscle in Angina

Summary: Previous studies have shown that interventions which modestly increase blood nitrite_ improve skeletal muscle function on exercise while sparing oxygen, and have been also shown to open up the blood flow during periods of oxygen deprivation. Inorganic nitrate in the diet is absorbed into the bloodstream, concentrated and reduced by bacteria in the mouth to nitrite, which is then absorbed into the bloodstream. .~The purpose of this study is to look at the effects of oral inorganic nitrate supplementation on clinical markers of heart ischaemia and the frequency of angina.
Inclusion criteria: inclusion criteria:

 Patients aged 18 and over with chronic stable angina (≥2 months duration).

 inclusion criteria Following screening visit:

 A positive exercise ECG (1mmSTD at J+0.08 seconds) on a modified Bruce protocol treadmill exercise test.

 A positive dobutamine stress echocardiogram,

 and/or a positive myocardial perfusion scan (MPI),

 and/or a positive coronary angiogram.

Exclusion criteria: :

 Unable to do exercise test

 Women of child bearing potential

 If of a racial origin at risk of glucose-6-phosphate dehydrogenase (G6PD) deficiency, G6PD will be excluded prior to inclusion in the study

 Resting STD>=1mm

 NYHA 3 or 4 HF or LVEF<45%

 Myocardial infarction or revascularisation within the last two months

 Left bundle branch block (LBBB)


Optimizing Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke

Summary: SELECT is a multicenter, observational prospective study implementing a protocol to acquire imaging and clinical variables known to affect clinical outcomes after endovascular therapy in an effort to evaluate and compare the different selection methods and criteria currently used in practice for acute ischemic stroke patients in the anterior circulation with large vessel occlusion. The study aim is to evaluate prospectively different selection methodologies for endovascular therapy, to compare them against each other to identify which method provides the highest predictive ability in the selection of patients for IAT and to devise a formula that predicts patients' outcomes.~This study will enroll patients based on the recent AHA guidelines (July 2015) regarding treatment of patients with acute ischemic strokes and large artery occlusions in the anterior circulation.~Our goal is to collect complete imaging, clinical, and 90 day follow up data on 250 endovascular therapy patients as well as up to 250 concurrent medical management patients as a comparison group.
Inclusion criteria: inclusion criteria:

 Eligible patients will be:

 Adults (≥18years) with the final diagnosis of an acute ischemic stroke

 CT-Angiogram proven, large artery occlusion (LAO) in the internal carotid artery (ICA), middle cerebral artery (MCA -M1 or M2 site) locations

 NIH Stroke Scale ≥6 (NIHSS) OR proven LAO on imaging (must be from designated LAO listed on inclusion #2)

 LSN (last seen normal) to groin puncture (≤ 8 hours) in thrombectomy arm; LSN to presentation to endovascular capable center (≤ 8 hours) in medical arm

 Baseline modified Rankin Scale score of 0-1

 Signed Informed Consent obtained

 Subject willing to comply with the protocol follow-up requirements

 Anticipated life expectancy of at least 3 months

 IV-tPA eligible patients must meet AHA guidelines

Exclusion criteria: :

 Patients are excluded if:

 Inability to undergo CT-Angiography and/or CT-Perfusion imaging (e.g., renal insufficiency, iodine/contrast allergy)

 Co-morbid psychiatric or medical illnesses that would confound the neurological assessments

 Subject is participating in another mechanical neuro-thrombectomy device trial (intervention) or any other trial where the study procedure or treatment might confound the study endpoint.


Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus

Summary: The purpose of this study is to evaluate the safety and efficacy of repeated intravenous infusions of the study drug BT063 in patients with Systemic Lupus Erythematosus (SLE) compared with people who receive a placebo.
Inclusion criteria: inclusion criteria:

 Eligible male and female subjects, Age ≥ 18 and ≤ 75 years with Body mass index ≥ 18 and ≤ 35 kg/m2 at screening visit

 Diagnosed SLE (defined by ≥ 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE) for at least 3 months before screening

 Moderate to severe SLE disease activity demonstrated by SLEDAI-2K total score ≥ 6, including skin and joint involvement

 CLASI Activity score ≥ 5 or at least 5 of 66/68 joints with pain and signs of inflammation

 Positive anti-nuclear antibodies (ANA) test at screening

 No change in concomitant medication for SLE activity maintenance and symptom control regarding type of medication and dose level for at least 8 weeks prior to baseline (for steroids and NSAIDs/pain medication 2 weeks)

 Normal electrocardiogram (ECG)

Exclusion criteria: :

 Active, severe neuropsychiatric SLE defined as any neuropsychiatric element scoring BILAG level A disease or lupus nephritis

 Diagnosed psoriasis

 Presence or history of malignancy within the previous 5 years

 Systemic antibiotic treatment within 2 weeks before baseline visit

 A positive diagnosis for viral hepatitis B or hepatitis C or Human immunodeficiency virus (HIV) or tested positive for tuberculosis as assessed or recent infection with Herpes Zoster or Herpes Simplex (Type 1 and Type 2), Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection or reactivation at screening

 Clinically significant hematologic abnormalities attributed to SLE: Haemoglobin < 8 g/dL; Platelets < 50 E9/L; Leucocytes < 2.0 E9/L

 Active or history of inflammatory bowel disease (including active or history of colitis)

 Received the following medications: - Rituximab within the last 48 weeks before screening - Belimumab within the last 12 weeks before screening - IV immunoglobulin (Ig) within the last 12 weeks before screening - Intramuscular (IM) or intra-articular glucocorticosteroids within the last 4 weeks before screening - IV cyclophosphamide within the last 6 months before screening - IV glucocorticosteroids (pulse therapy) within the last 6 months before screening

 Pregnant or nursing women or women who intend to become pregnant

 Known intolerance to immunoglobulins or comparable substances (e.g., significant vaccination reaction)

 Known intolerance to proteins of human origin

 History of clinically significant drug or alcohol abuse within the last 12 months


Use of Activated Recombinant FVII in Spinal Surgery

Summary: This trial is conducted in the United States of America (USA). The purpose of this clinical research trial is to understand how safe and effective Recombinant Activated FVII is for reducing bleeding and blood transfusions in patients undergoing spinal fusion surgery.
Inclusion criteria: inclusion criteria:

 Elective spinal fusion surgery.

Exclusion criteria: :

 History of thrombotic disorders (myocardial infarction, deep vein thrombosis, pulmonary embolism, stroke, disseminated intravascular coagulation or peripheral artery thrombosis)

 Any trauma within the last 3 months leading to hospitalization > 24 hours

 Angina or known coronary artery disease

['Acquired Bleeding Disorder', 'Spinal Fusion']

Acquired Bleeding Disorder
Spinal Fusion


Circumferential Lesions of the Glenoid Labrum

Summary: Objective: Symptomatic pan-labral or circumferential (360 degree) tears of the glenohumeral labrum are an uncommon injury. The purpose of this study is to report the prospective surgical results of circumferential lesions of the glenoid labrum using validated outcome instruments.~Methods: From July 2003 to May 2006, 41 shoulders in 39 patients with mean age of 25.1 years (range, 17 to 38) were prospectively enrolled in a multi-center study (3 surgeons) and treated for a circumferential (360-degree) lesion of the glenoid labrum. There were 34 men and 5 women, all with a primary diagnosis of pain and recurrent shoulder instability. All patients underwent arthroscopic repair of the circumferential labral tear with a mean of 7.1 suture anchors (range, 6 to 9). The outcomes in 39 of 41 shoulders (92.7% follow-up) were assessed at a mean final follow-up of 31.8 months (range, 24 to 53 months) with VAS pain and instability scales (0 to 10), a physical examination, the Single Assessment Numeric Evaluation Score (SANE), the American Shoulder and Elbow Surgeons Score (ASES), and the SF-12 score.
Inclusion criteria: inclusion criteria:

 Surgical documentation of Pan Labral Lesion of shoulder

 Pre-operative documentation of outcomes scores

Exclusion criteria: :

 lacking a Pan labral lesion

 other confounding pathology such as nerve deficit, chondral damage, rotator cuff tear


Osteoporosis and Chronic Obstructive Pulmonary Disease (COPD)

Summary: The goals of the trial are:~To determine the prevalence of osteoporosis in subgroups of COPD patients.~To look for risk factors of osteoporosis in COPD patients.~To create sub-groups for prospective research concerning the effects of bisphosphonates on osteoporosis variables in COPD patients.
Inclusion criteria: inclusion criteria:

 Age > 18 years

 Men and women

 COPD according to the ATS-guidelines, divided in severity according to the GOLD criteria

 Written consent

Exclusion criteria: :

 Age < 18 years

 No written consent