Psychotherapy Plus: Combining Cognitive Behavioral Therapy With tDCS

Summary: The study will investigate whether cognitive behavioral psychotherapy (CBT) combined with prefrontal transcranial direct current stimulation (tDCS) is more efficacious with regard to symptom reduction in depressed patients than CBT combined with sham-tDCS or CBT alone.
Inclusion criteria: inclusion criteria:

 - unipolar major depressive disorder

Exclusion criteria: :

 neurological diseases or relevant psychiatric diseases other than major depressive disorder

 current medication other than SSRI or Mirtazapine

 manic episodes (lifetime)

 psychotic symptoms (lifetime)

 treatment with psychotherapy within the past 2 years

 treatment with electroconvulsive therapy (lifetime)

['cognitive behavioral therapy', 'tDCS', 'sham-tDCS']

cognitive behavioral therapy
tDCS
sham-tDCS


Safety and Tolerability of CV8102 Alone and in Combination With a Rabies Virus Vaccine in Healthy Adults

Summary: The purpose of this clinical trial is to investigate the safety and tolerability of IM administered CV8102 and an IM administered combination of CV8102 and rabies vaccine in humans.
Inclusion criteria: inclusion criteria:

 Compliant with protocol procedures and available for clinical F/U until the protocol-defined end of the trial

 Physical examination and laboratory results without clinically significant findings

 Body Mass Index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2

 Subjects must use reliable forms of contraception (barrier method with spermicidal agent or true abstinence) and must refrain from sperm donation during treatment and the 4-week F/U period after the last treatment.

Exclusion criteria: :

 Use of any investigational or non-registered product (adjuvant, drug) other than CV8102 within 4 weeks preceding the administration of the CV8102, or planned use of any such agent during the trial period

 Subject has received any licensed or non-licensed vaccines within 4 weeks prior to the administration of CV8102 alone or in combination with the licensed rabies vaccine or planned vaccinations during the trial period

 Any treatment with immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of CV8102 alone or in combination with the licensed rabies vaccine. The use of inhaled and nasal steroids, as well as topical steroids outside the vaccination area, will be permitted

 Any medically diagnosed or suspected immune deficient condition based on medical history and physical examination

 History of autoimmune disease or suspected autoimmune disease based on medical history and physical examination that cannot be ruled out based on further examinations

 Administration of immunoglobulins (Igs) and/or any blood products within the 3 months preceding the administration of CV8102 or licensed rabies vaccine

 Acute disease at the time of enrolment. Acute disease is defined as the presence of any acute condition including but not limited to non-febrile or febrile common colds, urinary tract infections, inflammatory, allergic or traumatic conditions that may interfere with safety assessment of the investigational products

 Presence or evidence of significant acute or chronic disease, in particular heart disease including coronary artery disease and chronic pulmonary diseases (e.g., chronic obstructive pulmonary disease [COPD]); uncontrolled medical or psychiatric illness (subjects with uncomplicated chronic diagnoses stable and treated for ≥ 3 months e.g., mild hypertension well-controlled with medication, may be enrolled - provided the condition and its therapy are known not to be associated with an immunocompromised state or an autoimmune disease)

 Major congenital defects

 Known allergy to any component (or closely related substance) of the licensed rabies vaccine product

 Known type I allergy to beta-lactam antibiotics

 Evidence of current alcohol or drug abuse

 History of any neurological disorders or seizures

 Known seropositivity for human immunodeficiency virus (HIV), hepatitis B virus (HBV) (except in subjects previously vaccinated against HBV) or hepatitis C virus (HCV)

 Foreseeable non-compliance with protocol as judged by the Investigator

 History of any life-threatening anaphylactic reactions

 Subjects with impaired coagulation in whom an IM injection is contraindicated.

 Additional


Chest Ultrasound of ER Patients With Cough or SOB

Summary: Acute dyspnea (shortness of breath) is a common complaint for patients presenting to the Emergency Department (ED). The chest radiograph (CXR) has been the mainstay in evaluating patients with shortness of breath and often provides the timely diagnosis of pneumonia, pneumothorax, pulmonary edema, among other primary diseases of the lung. There are limitations with chest radiograph such as large body mass (e.g, obesity) and patient positioning. On occasion, chest radiography findings are difficult to interpret. Lung ultrasonography may offer a means of clarifying ambiguous results.~The objective of this study to determine the usefulness of point of care lung ultrasound in evaluating patients presenting to the ED with shortness of breath, cough and/or wheezing.
Inclusion criteria: inclusion criteria:

 Presenting to the Emergency Department with cough, wheezing and/or dyspnea (shortness of breath)

 Referred for CXR and/or CT scan

Exclusion criteria: :

 Life threatening medical condition requiring immediate treatment

 Unable to sit up for a chest ultrasound

 Unable to consent

 Pregnant

 Unable to speak, read and write in English


Circulating Tumour DNA (ctDNA) Rectal Cancer and the Relationship to Extramural Venous Invasion

Summary: In almost one third of patients with rectal cancer, cancer spreads through the bowel wall into nearby veins which can be seen on MRI scans and is known as mrEMVI. It has been observed that this is linked with worse survival due to the spread of cancer to the liver and other organs. The investigators think that this may occur by spread of cancer cells in the blood stream. Circulating cell-free tumour DNA (ctDNA) can be detected in the blood of patients with both metastatic and primary carcinoma (but not healthy individuals).~This trial does not interfere with the patient's routine treatment pathway. Participants will be chosen if they demonstrate mrEMVI on their baseline MRI scan. 20 patients who become mrEMVI positive (following pre-operative therapy) and 20 patients who are mrEMVI negative will have blood samples taken before and during surgery and a comparison will be made between the two groups. If the investigators can find a link between the cancer cells seen in blood to mrEMVI they may be able to use this test to help guide treatment in the future. This study will serve as the feasibility of a larger, comparative study.
Inclusion criteria: inclusion criteria:

 High-risk patients with biopsy proven rectal adenocarcinoma who will undergo long-course chemoradiotherapy (CRT) and who are potentially eligible for curative surgery

 Patients who have persistently (i.e. in baseline and post-treatment MRI) mrEMVI positive (with superior rectal vein invasion) or mrEMVI negative tumours.

 Patients aged over 18 years

 Negative (on CT) for metastatic disease

Exclusion criteria: :

 Under 18 years of age

 Patients with any metastatic disease

 Patients with a synchronous second malignancy

['Blood sample (mrEMVI positive patient)', 'Blood sample (mrEMVI negative patient)']

Blood sample (mrEMVI positive patient)
Blood sample (mrEMVI negative patient)


LNG-IUS for Treatment of Dysmenorrhea

Summary: Adenomyosis is a disease entity diagnosed when endometrial glands and stroma deep in the myometrium are associated with surrounding myometrial hypertrophy. The finding classically associated with adenomyosis is excessive uterine bleeding accompanied by worsening dysmenorrhea. The advent of endovaginal US has substantially improved the ability to diagnose adenomyosis. Different US features of adenomyosis have been reported, including uterine enlargement not explainable by the presence of leiomyomas, asymmetric thickening of the anterior or posterior myometrial wall, lack of contour abnormality or mass effect, heterogeneous poorly circumscribed areas within the myometrium, anechoic lacunae or cysts of varying sizes, and increased echotexture of the myometrium.~Transvaginal power Doppler application is useful in studying the vascular tree of adenomyosis and can aid clinicians in planning the most appropriate therapeutic strategy. The differential diagnosis using power Doppler sonography is based on vascular characteristics. Adenomyosis is characterized by a preserved vascular texture supply that results in dilated spiral arteries running perpendicular toward the myometrium into the endometrial surface. Leiomyomata exhibits a vascular tree that typically circumscribes the solid mass. 2D transvaginal power Doppler angiography should be used to improve diagnostic sensitivity and facilitate appropriate therapeutic intervention.~The levonorgestrel-releasing intrauterine system (IUS), Mirena, has been approved in Europe for contraception since 1990. Because of the suppressive effect of levonorgestrel on the endometrium, Mirena has also been proven to be effective for the management of menorrhagia and dysmenorrhea, and as a progestin component in postmenopausal hormone therapy. It was introduced in Taiwan in 1995 as an alternative therapy for idiopathic menorrhagia. Many cases of menorrhagia are caused by adenomyosis, and Mirena was, therefore, introduced for the treatment of adenomyosis in Taiwan.~The current study is designed to evaluate the best treatment modality for treatment of adenomyosis clinical by assessment of dysmenorrhea and or chronic pelvic pain by visual analogue scale and menstrual blood loss by menstrual diary, imaging by ultrasound and Doppler indices.
Inclusion criteria: inclusion criteria:

 Women have dysmenorrhoea and/or chronic pelvic pain secondary to adenomyosis.

 Planning for birth spacing for at least 2 years.

 Patient aged between 20-45 years old.

 Ultrasonographic and Doppler examination suggestive of adenomyosis.

 Living in a nearby area to make follow-up reasonably possible.

Exclusion criteria: :

 Pregnancy

 Evidence of defective coagulation.

 History or evidence of malignancy.

 Hyperplasia in the endometrial biopsy.

 Incidental adnexal abnormality on ultrasound.

 Contraindications to COCs.

 Absolute contraindication of LNG-IUS insertion.

 Previous endometrial ablation or resection

 Uninvestigated postcoital bleeding

 Untreated abnormal cervical cytology

['LNG-IUS', 'Combined oral contraceptives']


Perforated Marginal Ulcer After Gastric Bypass

Summary: A common late complication after gastric bypass surgery is marginal ulceration that is defined as ulcers at the margins of the gastrojejunostomy, mostly on the jejunal side. Most marginal ulcers respond to medical therapy and complicated or complex ulcer disease warrants operative intervention; specifically, perforated, penetrated, obstructing, bleeding and intractable marginal ulcers require surgical intervention.~Diverse operative strategies for addressing perforated marginal ulcers after gastric bypass have been described including I) Omental (Graham) patch repair, II) Revision of gastrojejunostomy, III) Irrigation and drainage, IV) any previous procedure with truncal vagotomy, V) Esophagojejunostomy, and VI) Reversal. We formally analyze our experience with the laparoscopic resection and repair of acutely perforated marginal ulcers after Roux-en-Y gastric bypass (RYGB), with or without concomitant resolution of technical risk factors for marginal ulceration.
Inclusion criteria: inclusion criteria:

 Laparoscopic repair of perforated marginal ulcer after RYGB

Exclusion criteria: :

 Perforated marginal ulcers after other bariatric procedures

 Repair by open approach

 Missing records and/or unreachable patients with scant information for analysis

['Ulcer Disease After Gastric Bypass', 'Marginal Ulcer', 'Perforated Marginal Ulcer', 'Acutely Perforated Marginal Ulcer']

Ulcer Disease After Gastric Bypass
Marginal Ulcer
Perforated Marginal Ulcer
Acutely Perforated Marginal Ulcer


Post-tonsillectomy Pain Control in Adults

Summary: This is a randomized prospective study to determine the optimal postoperative pain medication regimen for adults (18 years old and older) undergoing tonsillectomy with or without adenoidectomy for chronic tonsillitis and/or snoring and/or obstructive sleep apnea. All participants will undergo the same tonsillectomy surgical technique (with or without adenoidectomy) under general anesthesia and be randomized to one of three postoperative pain control regimens (all of which are commonly used pain medications for post-tonsillectomy pain):~Norco (Hydrocodone and Acetaminophen)~Percocet (Oxycodone and Acetaminophen)~Dilaudid and Tylenol (Acetaminophen)~Participants will be discharged home the day of surgery and will be sent home with questionnaires to assess their daily pain level, oral intake, amount of nausea/vomiting, and amount of pain medications taken for the 14 days following their surgery. Data will be collected and analyzed to determine if there is a difference in pain levels or oral intake or nausea/vomiting in the different pain regimen groups. Secondary endpoints will include weight change from preoperative weight to weight at 2-3 weeks after surgery in addition to postoperative complications including visits to the Emergency Department and post-tonsillectomy bleed rates.~Participants will be seen 1-2 weeks following their surgery in the ENT (Ear, Nose and Throat) clinic per normal postoperative protocol and will not require any specific clinic visits related to this study.
Inclusion criteria: inclusion criteria:

 18 years and older

 Surgical indications: Chronic tonsillitis, Snoring, Sleep apnea

 Surgical procedure: Tonsillectomy with monopolar cautery, hemostasis with monopolar cautery and/or suction cautery. The surgical procedure can also include Adenoidectomy with suction cautery

Exclusion criteria: :

 Additional surgical procedures (i.e. UPPP (uvulopalatopharyngoplasty), septoplasty, inferior turbinate reduction) during same surgery

 Pregnant females

 Indications: Suspected malignancy

 History of chronic pain or daily pain medication used for another medical problem

 History of liver disease

 Contraindications to preoperative Decadron

 Contraindications to pain regimen medications (Tylenol, Norco, Percocet, Dilaudid)

['Norco (Hydrocodone and Acetaminophen)', 'Percocet (Oxycodone and Acetaminophen)', 'Dilaudid (hydromorphone)', 'Tylenol (Acetaminophen)']

Norco (Hydrocodone and Acetaminophen)
Percocet (Oxycodone and Acetaminophen)
Dilaudid (hydromorphone)
Tylenol (Acetaminophen)

['Pain, Postoperative', 'Postoperative Nausea and Vomiting', 'Postoperative Hemorrhage', 'Body Weight Changes']

Pain
Postoperative
Postoperative Nausea and Vomiting
Postoperative Hemorrhage
Body Weight Changes


Bovine Lactoferrin to Prevent and Cure Iron Deficiency and Iron Deficiency Anemia in Complicated Pregnancies

Summary: The purpose of this study is to determine whether bovine lactoferrin is effective in preventing and curing iron deficiency and iron deficiency anemia in Hereditary Thrombophilia affected women during pregnancy.~The proposed clinical trial is considered as PHASE IV because in Italy bLf is commercialized by Grunenthal, as Lattoglobina® (capsules with 100 mg of bLf), to prevent and cure iron deficiency and iron deficiency anemia in pregnant women.
Inclusion criteria: inclusion criteria:

 pregnant women with one of genetic thrombophilia markers as factor V Leiden, prothrombin 20210A mutation, antiphospholipid antibodies, hyperhomocysteinemia and deficiencies of antithrombin, protein C, or protein S.

 pregnant women affected by HT and suffering of iron deficiency (ID) and iron deficiency anemia (IDA)

 different trimester of pregnancy

 previous miscarriage/s

 previous preterm delivery/ies

 iron disorders as iron deficiency and iron deficiency anemia are defined by the number of red blood cells <4.000.000/mL, the hemoglobin concentration ≤ 11 g/dL, the total serum iron ≤ 30 mg/dL and serum ferritin ≤12 ng/mL.

Exclusion criteria: :

 absence of iron deficiency and iron deficiency anemia

 non-pregnant women

 uncomplicated pregnancies

 no informed consent

 other treatments of iron supplementation

 recent blood transfusion

 other concomitant diseases

 ascertained allergy to milk proteins or to iron products.

['Lattoglobina (Grunenthal) containing bLf', 'FerroGrad by Abbott']

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

Iron Deficiency
Iron Deficiency Anemia
Pregnancy


A Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic Anemia

Summary: The aim of this prospective study was to evaluate the activity, safety and the duration of the response of low dose rituximab associated with standard oral prednisone as first line therapy in newly diagnosed warm autoimmune hemolytic anemia and cold hemagglutinin disease, and as second line therapy in warm autoimmune hemolytic anemia relapsed after standard oral prednisone. Further aim was to correlate the clinical response to biological parameters (cytokine and anti-erythrocyte antibody production in cultures).
Inclusion criteria: inclusion criteria:

 Newly diagnosed warm or cold AIHA, defined by symptomatic anemia and positive DAT, in the absence of underlying lymphoproliferative, infectious or neoplastic disease (according to the single Center diagnostic criteria).

 Idiopathic warm or cold AIHA relapsed after first line treatment with oral prednisone.

 Aged >18 years

 ECOG performance status grade 0, 1 or 2

 No psychiatric illness that precludes understanding concepts of the trial or signing informed consent

 Patients who have provided written informed consent prior to study participation, with the understanding that the consent may be withdrawn by the patient at any time without prejudice.

Exclusion criteria: :

 Cell or humoral immunologic deficit (congenital or acquired)

 Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent

 Active bacterial, viral, or fungal infection requiring systemic therapy HIV or HbsAg positive (with HBV-DNA+) or HCV-Ab positive (with HCV-RNA+) patients

 History of malignancies within 3 years prior to study entry

 Concomitant immunosuppressive or cytotoxic treatment

 Positive pregnancy test. Lactation.

 The presence of associated organ-specific autoimmune diseases do not constitute

['Autoimmune Hemolytic Disease (Cold Type) (Warm Type)']


Cardiovascular System in Obesity: Effect of Treatment

Summary: To determine the long-term efficacy of the combination therapy of phentermine and fenfluramine in conjunction with diet, exercise, and behavior modification in the treatment of simple, moderate obesity.
Inclusion criteria: Men and women, ages 18 to 60. Body weight was 130 to 180 percent of ideal body weight.
Exclusion criteria:

['Heart Diseases', 'Obesity', 'Vascular Diseases']

Heart Diseases
Obesity
Vascular Diseases


RISE: A Clinical Evaluation of the StarClose™ Vascular Closure System

Summary: To evaluate early ambulation in patients who receive the StarClose™ VCS post-percutaneous diagnostic procedure.
Inclusion criteria: Inclusion:

 Subject must be 18-85.

 Subject must be an acceptable candidate for an elective,non-emergent diagnostic procedure performed percutaneously via the common femoral artery through either a 5F or 6F procedural sheath.

 Subject is an acceptable candidate for emergent vascular surgery.

 Subject agrees to follow-up evaluations to assess for complications related to femoral access site.

 If among the 50 ultrasound sub-study Subjects enrolled,Subject agrees to have an ultrasound of femoral artery performed post-procedure during the 30 ± 7 days follow-up visit.

 Subject or legal representative has been informed of the nature of the study and agrees to provisions and has provided written informed consent as approved by the Institutional Review Board of respective clinical site.

 Exclusion:

 History of bleeding diathesis or coagulopathy including hemophilia, von Willebrand's disease, and/or a current, known platelet count <100,000 cells/mm3, or baseline INR > 1.7.

 Body Mass Index (BMI) ³ 35 kg/m2.

 Presence of significant anemia (Hgb < 10 g/dL, Hct < 30%).

 Advanced Subject refusal of blood transfusions, should transfusion become necessary.

 Participation in another trial of an investigational drug or device that has not yet completed follow-up requirements.

 Pregnant or lactating female.

 Clinically severe peripheral vascular disease in the ipsilateral limb, defined as severe claudication (walking < 100 feet), weak or absent pulses, or lower extremity vascular graft.

 History of ipsilateral femoral arterial puncture within previous three months or history of vascular closure device deployment in ipsilateral femoral artery at any time.

 Subject has unilateral or bilateral lower extremity amputation(s).

 Subject is unable to routinely walk at least 20 feet without assistance.

 Subject has an active systemic or cutaneous infection or inflammation.

 Subject has a pre-existing severe non-cardiac systemic disease or illness with a life expectancy of < 30 days.

 Subject has already participated in this Study.

 Subject has known allergy to nitinol.

 Access Site Exclusion-(*Evaluated via Limited Femoral Angiogram)

 Pseudoaneurysm or AV fistula present in ipsilateral femoral artery prior to arterial closure.*

 Puncture distal to the common femoral artery bifurcation or above the inguinal ligament which is typically defined by the inferior border of the inferior epigastric artery on sheath angiogram or the upper third of the femoral head by plain fluoroscopy.*

 The arterial lumen diameter at the arteriotomy site is < 5mm by visual estimate.*

 Angiographic evidence of calcified lesions at the arteriotomy site.*

 Difficulty inserting the introducer sheath at the start of the catheterization procedure due to vessel scarring or tortuosity, or anterior/posterior wall femoral artery punctures or greater than 2 ipsilateral arterial puncture attempts at the time of the percutaneous procedure.

 Known iliac or femoral stenosis >50% or previous bypass surgery or stent placement in the vicinity of the puncture site.

 Planned percutaneous procedure (diagnostic or intervention) in ipsilateral femoral artery prior to the 30-day follow-up evaluation.

 Subject has intra-procedural bleeding around the access site.

 Presence or previous use of an intra-aortic balloon pump through the existing arterial puncture site.

 Procedural Exclusion:

 Low molecular weight heparin administration within 8 hours of enrollment.

 For cases where anticoagulants are used, ACT level > 350 seconds at time of enrollment.

 Subject is determined to require treatment that will extend hospitalization (e.g. ---Subject is undergoing CABG surgery or staged PTCA).

 Persistent hypertension (SBP >180 or DBP >110 mm Hg) unresponsive to medical -therapy at time of enrollment.

 Placement of an ipsilateral femoral venous sheath during procedure.

 Presence of clinically significant hematoma (> 6 cm) in ipsilateral femoral artery prior to arterial closure.

 Placement of introducer sheath < 5F or > 6F during procedure.
Exclusion criteria:

['Peripheral Vascular Disease', 'Cardiovascular Disease']

Peripheral Vascular Disease
Cardiovascular Disease


Energy Drinks & Driving Ability

Summary: Rationale: Sleepiness behind the wheel is the cause of many traffic accidents. It is claimed that a 15-minute break and consuming an energy drink such as Red Bull® Energy Drink counteracts driver sleepiness.~Objective: The objective of this study is to compare driving simulator performance after (1) a 15-minute break with placebo, (2) a 15-minute break with Red Bull® Energy Drink, and (3) continued driving.~Study design: A double-blind, placebo-controlled crossover study. Study population: Healthy human volunteers, 21-35 years old.~Intervention: Each subject performs 3 test days:~4 hours continued driving~2 hours driving, a 15-minute break + Red Bull® Energy Drink, followed by 2 hours driving~2 hours driving, a 15-minute break + placebo, followed by 2 hours driving Main study parameters/endpoints: Standard Deviation of Lateral Position (SDLP), i.e. the weaving of the car.
Inclusion criteria: inclusion criteria:

 He/she is aged between 21 and 35 years old

 BMI between 21 and 30,

 55-85 kg body weight

 Non smoker

 Written informed consent

 Normal static binocular acuity, corrected or uncorrected

 Normal hearing

 Possession of a valid driver's license for at least 3 years

 Regular driver (> 5000 km / year)

 Be considered as reliable and mentally capable of adhering to the protocol.

Exclusion criteria: :

 Current drug use (positive urine drug screen on the presence of amphetamines (including MDMA), barbiturates, cannabinoids, benzodiazepines, cocaine, and opiates) as will be assessed by a urine drug test

 Use of psychoactive medication

 Pregnancy

 Positive alcohol breath test

 Prior enrolment in the same study

 Physical or mental illness

 Excessive alcohol use (>21 alcoholic drinks per week)

 Intake of caffeine-containing beverages under 2 or over 4 glasses per day

 Regular consumption of Energy Drinks (>1 per month)

 Shift worker (or no regular sleep pattern)

 Epworth Sleepiness Score (ESS) > 10


A Simple Clinical Tool to Help Diagnose Pulmonary Embolism: Phase 1

Summary: The goal of this project is to determine if the change in oxygen saturation during deep inspiration (augmented pulse oximetry) can be used as a method to rule out pulmonary embolism (PE). The investigators propose to evaluate a simple, non-invasive clinical tool to help rule out PE. The investigators plan to measure the oxygen saturation of 40 consecutive patients with newly-diagnosed PE (within 60 minutes of diagnosis) and 80 matched controls who do not have a PE. Trained, blinded Respiratory Therapists or Study Coordinators will record each patient's oxygen saturation before, during, and after a 2-minute period of deep inspirations (vital capacity [the maximal amount of air that can be inhaled, measured in milliliters]) using an incentive spirometer. The investigators' central hypothesis is that persons with a PE will not respond to augmented pulse oximetry and will not significantly improve or normalize their oxygen saturation.
Inclusion criteria: inclusion criteria:

 18 years of age or greater.

 Agrees and able to participate in the study.

 Room air SpO2 (oxygen saturation) less than 92% and newly-diagnosed PE (or controls with no PE) based on CT angiogram result.

Exclusion criteria: :

 Clinical concern for instability.

 Systolic blood pressure less than 100 mm Hg.

 Heart rate ≥140 beats per minute.

 Oxygen saturation less than 85% with more than 4 L supplemental oxygen.

 Unable to participate/comply with instructions for using the incentive spirometer.

 Patients from the Federal Medical Center in Rochester, Minnesota.

 Patients who do not speak English (due to the need for expediency).

 Patients will be under the care of the Emergency Department team who have the skills and resources to monitor and treat patients if they were to become unstable.

['Augmented pulse oximetry using incentive spirometer.', 'Incentive spirometer.']


Evaluation of Reactive Oxygen Metabolites in the Value of COPD

Summary: This study through the long-term observation followed up for 2 years to find the change of the COPD patients blood ROMs, systematically evaluate the relationship between ROMs and the severity of COPD. Evaluate the differences of prognosis between the different oxidative stress level (according to the level of ROMs are divided into higher and normal phenotype). Explore the new oxidative stress evaluation index ROMs application value in COPD.
Inclusion criteria: inclusion criteria:

 Clinical diagnosis of COPD according to GOLD 2013

Exclusion criteria: :

 A history of asthma or other chronic lung diseases Take Antioxidant therapy There are new or recurrent symptomatic myocardial ischemia, severe arrhythmia, cardiac insufficiency cerebrovascular disease Senile dementia or cognitive impairment cancer Severe liver and kidney and other viscera function insufficiency Language communication barriers Limb activity disorder The last 3 months participated in sports training

['COPD(Chronic Obstructive Pulmonary Disease)']


Response of Older Adults to Influenza Vaccination With Regard to Cytomegalovirus (CMV) Status

Summary: The study is being undertaken to evaluate responses to seasonal influenza vaccine in older adults with respect to their CMV status. CMV is cytomegalovirus and is an organism that infects many people, but does not usually cause disease in the individual unless they are immunocompromised i.e. their immune system is not working well such as in the case of HIV infection. CMV is believed to have infected up to 80% of individuals in the age group we will be looking at in our study and we are interested in whether this infection affects their responses to vaccination.
Inclusion criteria: inclusion criteria:

 No contraindications to vaccination as specified in the Green Book - Immunisation Against Infectious Disease, HMSO.

 Written informed consent obtained

 Subject aged no less than 50 years 0 days and no older than 79 years and 364 days at enrollment.
Exclusion criteria:


A Comparison Between Intravenous Iron Sucrose to Its Combination With Oral Iron Supplements for the Treatment of Postpartum Anemia

Summary: This study is aimed to compare the efficacy of two mode of iron administration to treat post partum anemia - a single dose of intravenous iron sucrose versus a single dose of iron sucrose and 6 weeks of treatment with oral iron supplement.
Inclusion criteria: inclusion criteria:

 Women above 18 years old after giving birth

 Women who suffer from iron deficiency anemia, defined as hemoglobin< 9.5 g/dl without one of the conditions that are described in the
Exclusion criteria:

['Iron sucrose 500 mg', 'Iron bisglycinate 60 mg']

Iron sucrose 500 mg
Iron bisglycinate 60 mg


Study of Survivors of Different Types of Cardiac Arrest and Their Neurological Recovery

Summary: After successful resuscitation from certain types of cardiac arrest, total body cooling is now a well established treatment that improves the chances of the brain recovering. This however, has only been definitively proven after a certain type of cardiac arrest that is ventricular fibrillation / ventricular tachycardia. The purpose of this study is to explore if total body cooling is beneficial for patients recovering from another type of cardiac arrest that is pulseless electrical activity.~HYPOTHESIS:~Patients undergoing post-cardiac arrest therapeutic hypothermia have better neurological outcomes if their initial arrest rhythm is pulseless electrical activity (PEA) in comparison to asystole.
Inclusion criteria: inclusion criteria:

 Admission to adult ICU (age ≥18 years) at London Health Sciences Centre

 Primary reason for ICU admission: postcardiac arrest

 Both in-hospital and out-of-hospital cardiac arrest will be included

 ICU admission between Jan 2008 and Dec 2012.

Exclusion criteria: :

 - ICU admissions primarily for reasons other than cardiac arrest.

['No treatment', 'Therapeutic hypothermia']

['Postcardiac Arrest', 'Pulseless Electrical Activity', 'Asystole']

Postcardiac Arrest
Pulseless Electrical Activity
Asystole


Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration

Summary: The purpose of this study is to determine whether Allogeneic Cardiosphere-Derived Cells (CAP-1002) is safe and effective in decreasing infarct size in patients with a myocardial infarction.
Inclusion criteria: inclusion criteria

 History of MI (STEMI or NSTEMI) within the prior 12 months due to a coronary artery event and evidenced by at least two of the following: typical ischemic symptoms, serial ST-T changes (new ST elevation or new left bundle block) and/or elevated troponin or CK-MB >5 times the upper limit of normal. Also at least one of the following: development of pathological Q wave ECG changes, imaging evidence of new loss of viable myocardium, or new regional wall motion abnormalities.

 History of percutaneous coronary intervention (PCI), with stent placement resulting in TIMI flow = 3, in the coronary artery supplying the infarcted, dysfunctional territory and through which the treatment will be infused.

 At least one assessment of left ventricular ejection function (LVEF) ≤0.45 as determined by any one of the standard modalities (echocardiography, ventriculography, nuclear imaging, CT and/or MRI) prior to or during the screening period.

 For subjects that fulfill the criteria of Recent MI (i.e., within 90 days of MI) at time of screening visit: assessment must be post-reperfusion after index MI and the most recent test prior to or during the screening period.

 For subjects that fulfill the criteria of Chronic MI (i.e., greater than 90 days from MI) at the time of screening visit: assessment must be at least 21 days post-reperfusion after index MI and the most recent test prior to or during the screening period.

 Note: subjects may screen as a Recent MI but be randomized into the Chronic MI strata if the infusion date is > 90 days post-MI.

 Left ventricular infarct size of ≥ 15% of left ventricular mass in the qualifying infarct-related region to be infused as determined by centrally read screening MRI, with associated thinning and/or hypokinesis, akinesis, or dyskinesis, with no large aneurysmal area in the infarcted regions.

 No further revascularization clinically indicated at the time the subject is assessed for participation in the clinical trial.

 Ability to provide informed consent and follow-up with protocol procedures.

 Age ≥ 18 years.

Exclusion criteria:

 Subjects with a history of coronary artery bypass surgery, and a patent graft (arterial or saphenous vein graft) attached to the coronary artery to be infused.

 Diagnosed or suspected myocarditis.

 History of cardiac tumor, or cardiac tumor demonstrated on screening MRI.

 History of acute coronary syndrome in the 4 weeks prior to study infusion.

 History of previous stem cell therapy.

 History of radiation treatment to the central or left side of thorax.

 Current or history (within the previous 5 years) of systematic auto-immune or connective tissue disease including, but not limited to, giant cell myocarditis, cardiac or systemic sarcoidosis, Dressler's syndrome, chronic recurrent or persistent pericarditis.

 History of or current treatment with immunosuppressive , anti-inflammatory, or other agents to treat manifestations of systemic immunologic reactions, including chronic systemic corticosteroids, biologic agents targeting the immune system, anti-tumor and anti-neoplastic drugs, anti-VEGF, or chemotherapeutic agents within 3 months prior to enrollment.

 Prior ICD and/or pacemaker placement where study imaging site has not been trained and certified specifically for this protocol to conduct cardiac MRI in subjects with ICD and/or pacemaker placement.

 a. Presence of a pacemaker and/or ICD generator with any of the following limitations/conditions are excluded: i. Manufactured before the year 2000, ii. Leads implanted < 6 weeks prior to signing informed consent, iii. Non-transvenous epicardial, abandoned, or no-fixation leads, iv. Subcutaneous ICDs, v. Leadless pacemakers, vi. Any other condition that, in the judgement of device-trained staff, would deem an MRI contraindicated.

 b. Pacemaker dependence with an ICD (Note: pacemaker-dependent candidates without an ICD are not excluded).

 c. A cardiac resynchronization therapy (CRT) device implanted < 3 months prior to signing informed consent.

 Estimated glomerular filtration rate < 30 mL/min.

 Participation in an on-going protocol studying an experimental drug or device, or participation in an interventional clinical trial within the last 30 days.

 Diagnosis of arrhythmogenic right ventricular cardiomyopathy.

 Current alcohol or drug abuse.

 Pregnant/nursing women and women of child-bearing potential that do not agree to use at least two forms of active and highly reliable method(s) of contraception. Acceptable methods of contraception include contraceptive pills, depo-progesterone injections, a barrier contraceptive such as a condom with or without spermicide cream or gel, diaphragms or cervical cap with or without spermicide or gel, or an intrauterine device (IUD).

 Human Immunodeficiency Virus (HIV) infection.

 Viral hepatitis.

 Uncontrolled diabetes (HbA1c>9%).

 Abnormal liver function (SGPT/ALT > 3 times the upper reference range) and/or abnormal hematology (hematocrit < 25%, WBC < 3000 µl, platelets < 100,000 µl) studies without a reversible, identifiable cause.

 Sustained ventricular tachycardia (VT) or non-sustained ventricular tachycardia > 30 beats, not associated with the acute phase of a previous MI (> 48 hours after the MI onset) or a new acute ischemic episode.

 Ventricular fibrillation not associated with a new acute ischemic episode.

 New York Heart Association (NYHA) Class IV congestive heart failure.

 Evidence of tumor on screening chest/abdominal/pelvic (body) CT scan.

 Any prior transplant.

 Known hypersensitivity to dimethyl sulfoxide (DMSO).

 Known hypersensitivity to bovine products.

 Any malignancy within 5 years (except for in-situ non-melanoma skin cancer and in-situ cervical cancer) of signing the ICF.

 Any condition or other reason that, in the opinion of the Investigator or Medical Monitor, would render the subject unsuitable for the study.

['CAP-1002 Allogeneic Cardiosphere-Derived Cells', 'Placebo']


Endothelial Dysfunction in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)

Summary: The purpose of the study is to determine a possible association between the clinical entity of exacerbation, markers of systemic inflammation and endothelial dysfunction in patients with COPD.
Inclusion criteria: inclusion criteria:

 presence of COPD according to standard criteria

 acute exacerbation of COPD according to recommended international criteria

 over 40 years of age

 history of at least 10 py

Exclusion criteria: :

 pneumonia

 history or signs of congestive heart failure,

 acute myocardial infarction

 thoracotomy incl. resection of lungtissue

 interstitial lung disease

 acute or chronic renal failure

 active malignancy

 autoimmune disease

['Chronic Obstructive Pulmonary Disease (COPD)', 'Inflammatory Disease', 'Endothelial Dysfunction']


Chemoprophylaxis and Plasmodium Falciparum NF54 Sporozoite Immunization Challenged by Heterologous Infection

Summary: Malaria, a disease caused by the parasite Plasmodium, is one of the world's major infectious diseases. With approximately 627.000 deaths a year, it is both a chief cause of morbidity and mortality as well as a significant contribution to ongoing poverty in endemic countries. Ultimately, the key to malaria control, and hopefully eradication, would be an effective vaccine. Though a number of vaccine-candidates have entered the pipeline of pre-clinical and clinical development, they have yet to achieve the level of efficacy necessary for effective malaria prevention. It has been shown previously that if healthy human volunteers taking chloroquine chemoprophylaxis are repeatedly exposed to Plasmodium parasites through the bites of infected mosquitoes, they are fully protected against a later challenge infection with a 'homologous' (genetically similar) Plasmodium parasite. This process is known as ChemoProphylaxis and Sporozoites, or CPS-immunization. One of the obstacles to developing an effective vaccine is the genetic heterogeneity of malaria parasites. To further consider the development of whole-parasite based vaccines against malaria and in order to better understand the protective immunity induced by CPS-immunization, it is essential to investigate whether heterologous protection against genetically diverse (heterologous) P. falciparum clones can be induced.~This is a single center, randomized, double-blind study to determine whether healthy volunteers immunized with P. falciparum NF54 parasites under chloroquine prophylaxis are protected against a challenge infection with the genetically distinct NF135.C10 or NF166.C8 P. falciparum clones.
Inclusion criteria: inclusion criteria:

 In order to be eligible to participate in this study, a subject must meet all of the following criteria:

 Subject is aged ≥ 18 and ≤ 35 years and in good health.

 Subject has adequate understanding of the procedures of the study and agrees to abide strictly thereby.

 Subject is able to communicate well with the investigator, is available to attend all study visits, lives in proximity to the trial centre (<10 km) or (if >10km) is willing to stay in a hotel close to the trial centre during part of the study (day 5 post-infection until three days post-treatment). Furthermore the subject will remain within the Netherlands during the challenge period, not travel to a malaria-endemic area during the study period, and is reachable (24/7) by mobile telephone throughout the entire study period.

 Subject agrees to inform his/her general practitioner about participation in the study and to sign a request to release by the General Practitioner (GP) any relevant medical information concerning possible contra-indications for participation in the study.

 Subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period and for a defined period thereafter according to current Sanquin guidelines.

 For female subjects: subject agrees to use adequate contraception and not to breastfeed for the duration of study.

 Subject has signed informed consent.

 Subject agrees to refrain from intensive physical exercise (disproportionate to the subjects usual daily activity or exercise routine) for ten days following each immunization and during the malaria challenge period.

Exclusion criteria: :

 A potential subject who meets any of the following criteria will be excluded from participation in this study:

 Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, such as cardiovascular, pulmonary, renal, hepatic, neurological, dermatological, endocrine, malignant, haematological, infectious, immunodeficient, psychiatric and other disorders, which could compromise the health of the volunteer during the study or interfere with the interpretation of the study results. These include, but are not limited to, any of the following.

 1.1 Body weight <50 kg or Body Mass Index (BMI) <18.0 or >30.0 kg/m2 at screening.

 1.2 A heightened risk of cardiovascular disease, as determined by: an estimated ten year risk of fatal cardiovascular disease of ≥5% at screening, as determined by the Systematic Coronary Risk Evaluation (SCORE); history, or evidence at screening, of clinically significant arrhythmia's, prolonged QT-interval or other clinically relevant ECG abnormalities; or a positive family history of cardiac events in 1st or 2nd degree relatives <50 years old.

 1.3 A medical history of functional asplenia, sickle cell trait/disease, thalassaemia trait/disease or G6PD deficiency.

 1.4 History of epilepsy in the period of five years prior to study onset, even if no longer on medication.

 1.5 Positive Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) screening tests.

 1.6 Chronic use of i) immunosuppressive drugs, ii) antibiotics, iii) or other immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period.

 1.7 History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years.

 1.8 Any history of treatment for severe psychiatric disease by a psychiatrist in the past year.

 1.9 History of drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset, positive urine toxicology test for cocaine or amphetamines at screening or prior to infection or positive urine toxicology test for cannabis at inclusion or prior to infection.

 For female subjects: positive urine pregnancy test at screening or prior to infection.

 Any history of malaria, positive serology for P. falciparum, or previous participation in any malaria (vaccine) study.

 Known hypersensitivity to or contra-indications (including co-medication) for use of chloroquine, Malarone or artemether-lumefantrine, or history of severe (allergic) reactions to mosquito bites.

 Receipt of any vaccinations in the 3 months prior to the start of the study or plans to receive any other vaccinations during the study period or up to 8 weeks thereafter.

 Participation in any other clinical study in the 30 days prior to the start of the study or during the study period.

 Being an employee or student of the department of Medical Microbiology of the Radboudumc or the department of Internal Medicine.

 Any other condition or situation that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

['CPS-immunization', 'malaria challenge infection, P. falciparum NF135.C10', 'malaria challenge infection, P. falciparum NF166.C8', 'malaria challenge infection, P. falciparum NF54', 'atovaquone/proguanil']

CPS-immunization
malaria challenge infection
P. falciparum NF135.C10
malaria challenge infection
P. falciparum NF166.C8
malaria challenge infection
P. falciparum NF54
atovaquone/proguanil


Alternative Dosing Regimens in the Pharmacotherapy of Insomnia

Summary: The purpose of this study is to evaluate whether drug efficiency of zolpidem and amitriptyline can be conditioned according to learning theory in patients with primary insomnia.
Inclusion criteria: inclusion criteria:

 age between 18 years to 69 years

 fluent in German language

 provide written informed consent

 ability to understand the explanations and instructions given by the study physician and the investigator

Exclusion criteria: :

 Sleep disorders caused by medical factors (e.g. sleep apnea, restless legs syndrome, narcolepsy, substance-induced insomnia)

 Contraindications to study medication intake according to the information sheet for health professionals (Summary of medicinal Product Characteristics, SmPC; Fachinformation in Germany) assessed by physical examination (including ECG) and medical history

 allergies to amitriptyline hydrochloride or any of its ingredients

 allergies to zolpidem or any of its ingredients

 acute intoxication with alcohol, analgetics, hypnotics or any other psychotropic drug

 urinary retention

 delirium

 untreated closed-angle glaucoma

 prostatic hyperplasia

 pyloric stenosis

 paralytic ilius

 suicidal thoughts

 liver/ kidney/ pulmonary insufficiency

 myasthenia gravis

 hypokalemia

 bradycardia

 coronary heart disease, cardiac arrhythmias, long QT syndrome or other clinically relevant cardiac disorders

 increased risk of seizures/ history of seizures

 substance dependence syndrome/ history of substance dependence syndrome

 Allergies to ingredients of placebo or novel-tasting drink (CS)

 currently pregnant (verified by urine pregnancy test) or lactating

 patients scoring ≥12 on the Epworth Sleepiness Scale

 patients scoring below 8 or above 21 on the Insomnia Severity Index

 patients suffering from a mental disorder as verified by the SCID (major depression; psychosis; brain injury; substance abuse or dependency syndrome during the last 6 months before V1)

 nicotine consumption > 10 cigarettes/day

 unwillingness to refrain from alcohol consumption throughout the study

 Concomitant medication interfering with study medication intake due to potential interactions (all psychotropic medication including analgetics and muscle relaxants, hypericum derivatives; antihypertensives; anti-arrhythmic agents; antibiotics; cisaprid; anti-malaria drugs; diuretics; imidazole antifungals; cumarin derivatives; antihistaminics; calcium channel blockers; medications that enlarge the QT interval or may lead to hypokalemia)

 change in concomitant medication regime during the last 2 weeks prior to visit 1 or after randomization

 intake of psychotropic medication during the last 3 months

 participation in any other clinical trial 3 months prior to visit 1

 women of childbearing age not using 2 highly effective contraceptive methods

 employee of the Sponsor or the principal investigator

['Amitriptyline', 'Zolpidem', 'Amitriptyline', 'Placebo']

Amitriptyline Zolpidem Amitriptyline Placebo


PFO ACCESS Registry

Summary: Closure of Patent Foramen Ovale with the AMPLATZER® PFO OCCLUDER in patients with at least two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional therapy.
Inclusion criteria: inclusion criteria:

 Patent foramen ovale (PFO); recurrent cryptogenic stroke; failed antiplatelet/anticoagulant therapy

Exclusion criteria: :

 International normalized ration (INR) outside of 2-3; intracardiac thrombus (subjects may be enrolled after resolution of thrombus)

['Device closure with the AMPLATZER PFO Occluder']


Age Dependend Diagnostic Thresholds for Osteoporosis Bindex Ultrasonometer

Summary: This study is designed for clinical validation of the novel ultrasound device (Bindex®, Bone Index Finland Ltd.). In a preliminary study technique has been validated in Finnish elderly woman population with 285 healthy and 56 osteoporotic subjects (n = 341 in total). Significant and good correlation was observed between Density Index (DI) determined with Bindex and femoral bone mineral density determined with DXA (r = 0.65 - 0.70). In addition, with determination of 90% sensitivity and specificity thresholds, significant number (65-75%) of patients could be diagnosed without additional verification with DXA.~First, the thresholds for DI will be determined by measuring 70 osteoporotic and 70 healthy patients (n = 140) with Bindex and DXA within four decades of age; age 50 to 59 years, age 60 to 69 years, age 70 to 79 years, and age 80 to 89 years. The feasibility of DI for diagnostics of osteoporosis and evaluation of bone mineral density (BMD) will be assessed. The thresholds for the BMD estimate obtained with DI will be determined for osteoporotic and non-osteoporotic patients. For fracture risk assessment, DI measurements are used to predict the outcome of currently available fracture risk assessment tools.~To investigate optimal configuration of ultrasound parameters and patient characteristics for prediction of proximal femur and lumbar spine BMD for women in each four decades of age; 50 to 59 years, 60 to 69 years, 70 to 79 years, and 80-89 years.~To develop national diagnostic thresholds for DI in prediction of osteoporosis status with a reference female population (American-Caucasian) in each four decades of age; 50 to 59 years, 60 to 69 years, 70 to 79 years, and 80-89 years.
Inclusion criteria: inclusion criteria:

 Female sex

 Age 50 to 89 years

Exclusion criteria: :

 Those who have opted out of being contacted for research on their general Park Nicollet clinic consent will not be recruited by mail

 Inability to sign consent form due to cognitive impairment. Those with dementia (ICD-9 diagnosis codes 331.0, 294.1, 294.10, 294.11, or 294.8) will excluded from mailed recruitment

 Measurement of hip BMD is not feasible (for example, those who have had bilateral hip replacement surgeries or who cannot have central DXA because of their body weight)

 Open leg or arm wounds at sites where ultrasound measurements are supposed to be taken, precluding such measurements


Iron Deficiency Anemia Can be an Indication for Treatment of Subclinical Hypothyroidism

Summary: To determine whether iron deficiency anemia can be an indication for the treatment of subclinical hypothyroidism.
Inclusion criteria: inclusion criteria:

 Clinical diagnosis and laboratory confirmation of iron deficiency anemia and subclinical hypothyroidism

 Must be able to swallow tablets

Exclusion criteria: :

 Multifactorial anemia or anemia due to other reasons

 Iron deficiency anemia requiring urgent intervention- cardiac ischemia, severe anemia, GI or GU losses due to malignancy and or acute/subacute big loses by respiratory, Gİ, GU, etc. system

 Prior thyroid disorder and/or treatment history

 Presence of any other co-morbid disease like renal insufficiency/ failure, coronary heart disease, hypertension, diabetes mellitus, any endocrine system disease other than subclinical hypothyroidism

['Ferrous sulfate tablets 325 mg, po, TID', 'Ferrous sulfate plus levothyroxine']

Ferrous sulfate tablets 325 mg
po
TID
Ferrous sulfate plus levothyroxine

['Iron Deficiency Anemia', 'Subclinical Hypothyroidism']

Iron Deficiency Anemia
Subclinical Hypothyroidism


Memory Aid - Working Memory Training in Patients With Mild Cognitive Impairment.

Summary: Background:~Mild Cognitive Impairment (MCI) is a condition characterized by memory problems more severe than normal cognitive changes due to old age, and less severe than dementia. Reduced working memory (WM) is regarded as one of the core symptoms of an MCI-condition. Recent studies have indicated that WM can be improved trough computer based training.~Objectives:~The objective of the study is to evaluate if working memory training is effective in improving working memory in elderly MCI-patients. Further, to evaluate if cognitive training relates to structural changes in the white and gray matter of the brain, assessed by structural Magnetic Resonance Imaging. Cognitive phenotypes related to memory impairment and progression to dementia will also be investigated.~Patients and Methods:~The proposed study is a blinded, randomized and controlled trail that will include 90 elderly patients from a Memory Clinic diagnosed with MCI. The groups will be randomized to either training or a placebo version. The intervention is computerized working memory training performed for 45 minutes over 25 sessions. Neuropsychological assessment and structural MRI will be performed before, 6 and 12 months after training.~Relevance:~Currently there is no known treatment available for mild memory impairment/MCI, and few studies on specific cognitive training in MCI-patients have been performed. The proposed study has received funding from a Norwegian Health Region. If computer based training results in positive changes to memory functions in MCI patients this may represent a new, cost-effective treatment. Secondly, evaluation of training induced structural changes to grey or white matter may improve our understanding of the mechanisms behind effective cognitive interventions in MCI patients.
Inclusion criteria: inclusion criteria:

 Patients who meet the Peterson diagnostic criteria of MCI:

 memory complaints (preferably confirmed by an informant).

 memory impairment according to age and education.

 preserved general cognitive function.

 intact activities of daily living, absence of dementia.

Exclusion criteria: :

 head trauma with post-traumatic loss of conscience for 30 minutes during lifespan.

 loss of senses (blindness, deafness).

 photo-sensitive epilepsy.

 unsuitability for Magnetic Resonance Imaging-examination due to metal foreign bodies or severe claustrophobia.

 drug and/or alcohol abuse.

['Computerized Working Memory Training.']


Robot Aided Rehabilitation - Multi-joint Evaluations

Summary: Sensory and motor impairments following stroke can lead to substantial disability involving the arm and hand. The investigator hypothesized that excessive local and cross-coupled stiffness, diminished individuation and proprioceptive acuity will be present among multiple degree of freedom in the upper limb. The stiffness and spasticity will increase with time post-stroke. The objective of this study is to quantify the progression throughout the arm and hand during recovery from stroke. The investigator will measure the clinical assessment scores, and neuromechanical properties including range of motion, active and passive cross coupling, and spasticity by the IntelliArm robot.
Inclusion criteria: inclusion criteria:

 First focal unilateral lesion, ischemic or hemorrhagic

 Had a stroke less than a month prior to enrollment

 Rated between stages 1-4 on the Chedoke McMaster Stroke Assessment Impairment Inventory: Stage of Recovery of the Arm

 Rated between stages 1-4 on the Chedoke McMaster Stroke Assessment Impairment Inventory: Stage of Recovery of the Hand

Exclusion criteria: :

 Apraxia

 Other unrelated or musculoskeletal injuries

 Unable to sit in a chair for 3 consecutive hours

 Score of less than 22 on the Mini Mental Status Exam

 Poor fit into equipment used in study which compromises proper use. This will be determined by the judgment of study staff


Safety and Efficacy Study of Losmapimod (GW856553) in Frequently Exacerbating Participants With Chronic Obstructive Pulmonary Disease (COPD)

Summary: This is a randomised, double-blind, parallel-group, multi-centre study evaluating 15 milligram (mg) twice daily/ Bi-daily (BID) of losmapimod versus placebo, in addition to standard of care (SoC).~The primary objective of this study is to explore the therapeutic potential of losmapimod as a treatment to reduce the rate of exacerbations in the subset of participants with moderate-to-severe COPD who are at high risk of exacerbation, having experienced two or more moderate/severe exacerbations in the preceding 12 months, and who have <=2% of blood eosinophils at screening. As secondary objectives safety, effects on lung function, quality of life, pharmacokinetic (PK), biomarkers of both disease and inflammation shall be evaluated.~The duration of the treatment period is variable but will be at least 26 weeks and up to a maximum of 52 weeks, with the end of study date being established once the final participant has been randomized. The purpose of the variable dosing regimen is to enable participants to remain in the study for a longer duration, as it is anticipated that this will increase the likelihood of observing exacerbation events without increasing the overall study duration. It will also enable safety data on dosing periods beyond 6 months to be generated.~Approximately 200 participants in a 1:1 ratio between losmapimod and placebo will be randomized to the study. Sample size re-estimation will be performed during the course of the study to potentially increase the sample size up to a maximum of 600 participants.
Inclusion criteria: inclusion criteria:

 COPD diagnosis and severity: Participants with a clinical history of COPD (established by a physician) in accordance with the following definition by the American Thoracic Society/European Respiratory Society, for at least 6 months prior to enrolment. Participants must have evidence of airflow obstruction, defined as post-bronchodilator FEV1 equal to or less than 80% of predicted normal value calculated using Third National Health and Nutrition Examination Survey (NHANES III) reference equation at Visit 1 and a FEV1 / FVC ratio <=70% at Screening (Visit 1). Note: Post-bronchodilator spirometry will be performed approximately 10-15 minutes after the participants has self-administered 4 inhalations (i.e., total 400/360 [microgram] mcg) of salbutamol/albuterol via a Metered Dose Inhaler (MDI) (use of spacer will be optional). The study-provided central spirometry equipment will calculate the FEV1/FVC ratio and FEV1 percent predicted values.

 Exacerbation History: A documented history (e.g., medical record verification) in the 12 months prior to Visit 1 of >=2 COPD exacerbations resulting in prescription for antibiotics and/or oral corticosteroids or hospitalisation or extended observation in a hospital emergency room or outpatient centre. Note: Prior use of antibiotics alone does not qualify as a moderate exacerbation unless the use was specifically for the treatment of worsening symptoms of COPD.

 Existing COPD maintenance treatment: Participants must be receiving daily maintenance treatment for their COPD for at least 3 months prior to Screening. Notes: Participants receiving only pro re nata or as needed (PRN) COPD medications are not eligible for inclusion in the study. All participants will continue on their current Standard of Care (SoC) COPD medications throughout the entire duration of the study.

 Tobacco use: Participants with a current or prior history of >=10 pack-years of cigarette smoking at Screening (Visit 1). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. One pack year =20 cigarettes smoked per day for 1 year or the equivalent. Number of pack years=(number of cigarettes per day/20) x number of years smoked.

 Sex: Male or female participants aged >=40 years at Screening (Visit 1). A female participant is eligible to participate if she is of non-child bearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milli-international unit/milliliter (MIU/mL) and estradiol <40 picogram/milliliter (pg/mL) (<140 [Picomoles per liter] pmol/L) is confirmatory] or if of child-bearing potential is using a highly effective method for avoidance of pregnancy from 30 days before the first dose, for the duration of dosing and until 2 weeks post last-dose.

 Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

 Corrected ECG QT interval (QTc)<450 milliseconds(msec) or QTc<480 msec for participants with bundle branch block. The QTc is the QT interval corrected for heart rate according to either Bazett's formula (QTcB), Fridericia's formula (QTcF), or another method, machine or manual over-read. For eligibility and withdrawal, ideally the same QT correction formula will be used for all participants. However, because this is not always possible, the same QT correction formula will be used for each individual participant to determine eligibility for and withdrawal from the study. The QTc will be based on single or averaged QTc values of triplicate ECGs obtained over a brief recording period.

Exclusion criteria: :

 Eosinophils: >2.0% blood eosinophils at Screening (Visit 1)

 Concomitant medication: COPD Medication: Participants currently on chronic treatment with macrolides or Roflumilast; Long term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen PRN use (i.e. <=12 hours per day) is not exclusionary. Multidrug and toxin extrusion (MATE) transporter 1 (MATE1) inhibitors: cimetidine, pyrimethamine, trimethoprim (short course treatment with trimethoprim is allowed). Other medications: Chronic maintenance therapy with anti-Tumor Necrosis Factor (anti-TNF), anti-Interleukin-1 (anti-IL1), phosphodiesterase type 4 (PDE4) inhibitors, or any other immunosuppressive therapy (not including steroids) within 60 days prior to dosing. Any other investigational drug within 30 days or 5 half lives, whichever is longer prior to Screening Visit.

 Other respiratory disorders: Participants with asthma (as primary diagnosis) lung cancer, bronchiectasis, active sarcoidosis, active lung fibrosis, cystic fibrosis, idiopathic pulmonary hypertension, active interstitial lung diseases or other active pulmonary diseases. Participants with alpha-1-antitrypsin deficiency as the underlying cause of COPD.

 Participants with clinically significant sleep apnea who require use of continuous positive airway pressure (CPAP) device.

 Participants who require a non-invasive positive pressure ventilation (NIPPV) device (Note: Use of non invasive ventilation (NIV) in hospital as part of the medical management of an acute exacerbation is permitted.)

 Lung resection: Participants who have undergone previous lung reduction surgery (e.g. lobectomy, pneumonectomy, or lung volume reduction).

 COPD stability: Less than 30 days prior to Visit 1 have elapsed from completion of a course of antibiotics or oral corticosteroids for a recent COPD exacerbation.

 Evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD on chest X-ray (posteroanterior with lateral) or computerised tomography (CT) scan (historic data up to 1 year may be used).

 Pulmonary rehabilitation program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1. Participants who are in the maintenance phase of a pulmonary rehabilitation program are not excluded.

 Alanine aminotransferase (ALT) >2x Upper limits of normal (ULN) and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

 Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).

 Malignancy: A current malignancy or previous history of cancer in remission for less than 12 months prior to Visit 1 (Participants that had localized carcinoma of the skin or cervix which was resected for cure will not be excluded).

 Other diseases/abnormalities: History or current evidence of clinically significant or uncontrolled cardiovascular, pulmonary, metabolic, neurological, endocrine (including uncontrolled diabetes or thyroid disease), renal, hepatic, haematological (including agranulocytosis) or gastrointestinal conditions that are uncontrolled on permitted therapy and in the opinion of the investigator and/or GSK Medical Monitor, places the participant at an unacceptable risk as participant in this trial or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study

 Viral infections: Presence of hepatitis B surface antigen (HBsAg), Hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. Note: Participants with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C Ribonucleic acid (RNA) polymerase chain reaction (PCR) test is obtained.

 A positive test for human immunodeficiency virus (HIV) antibody

 Tuberculosis (TB): Participant with active TB or who have previously tested positive for latent TB and not received treatment or prophylaxis following the positive test.

 Vaccination: Participants who have received live attenuated vaccines in the 6 weeks prior to randomization. The use of live attenuated vaccines during the treatment period and in the 4 weeks post-discontinuation of investigational product is prohibited.

 Drug/food allergy: Participants with a history of hypersensitivity to any of the study medications (e.g., lactose, magnesium stearate).

 Lactating females

 Pregnant females (as determined by positive urine human chorionic gonadotropin (hCG) test prior to dosing).

 Drug/alcohol abuse: Participants with a known or suspected history of alcohol or drug abuse within the last 2 years.

 Prior use of study medication/other investigational drugs: Participants who have received an investigational drug within 30 days of entry into this study or within 5 drug half-lives of the investigational drug, whichever is longer.

 Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study.

 Inability to read: In the opinion of the investigator, any participant who is unable to read and/or would not be able to complete study related materials.

 Non-compliance: Participants at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.

 Questionable validity of consent: Participants with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.

['Losmapimod tablets', 'Placebo tablets', 'Salbutamol MDI']

Losmapimod tablets
Placebo tablets
Salbutamol MDI

['Pulmonary Disease, Chronic Obstructive']


Relative Bioavailability of Iron and Folic Acid in New Test Supplement

Summary: Deficiencies of iron and folic acid during pregnancy can lead to adverse outcomes for the fetus, thus supplements are recommended. Adherence to current tablet-based supplements is documented to be poor. Recently a powdered form of micronutrients has been developed which may decrease side-effects and thus improve adherence. However, before testing the efficacy of the supplement as an alternate choice for supplementation during pregnancy, the bioavailability of the iron needs to be determined. The objective of this study is to measure the relative bioavailability of iron and folic acid from a powdered supplement that can be sprinkled on semi-solid foods or beverages versus a traditional tablet supplement in pregnant women.
Inclusion criteria: inclusion criteria:

 Healthy pregnant women between 18 and 45 years of age in the second or third trimester of pregnancy (24-32 weeks of gestational age).

 Normal Hb (Hb≥110g/L and Hb≤144g/L)

Exclusion criteria: :

 Chronic illness (clinically significant neurological, endocrine, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic diseases)

 A history or presence of hemosiderosis, hemochromatosis, peptic ulcer, regional enteritis, ulcerative colitis

 A history of or current use of IV iron therapy or erythropoietin therapy

 A history or presence of any clinically significant gastrointestinal pathology (eg. chronic diarrhea, inflammatory bowel disease, partial gastrectomy), unresolved gastrointestinal symptoms (eg. diarrhea or vomiting), steatorrhea, or other conditions known to interfere with the absorption, distribution, metabolism or excretion of iron or folic acid

 Abnormal hemoglobin electrophoresis ie. sickle cell anemia, thalassemia, etc.

 Current acute illness and/or taking antibiotics

 Known or suspected allergies to Materna®, or any ingredient present in Materna or SuppleFem Sprinkles or any of the foods to be consumed during the trial.

 Mildly to severely anemic women (Hb<110 g/L) or elevated hemoglobin (above 144g/L)

 Complications in pregnancy (including pregnancy induced hypertension, preeclampsia, a history of severe antepartum hemorrhage)

 Blood transfusion within last 3 months

['Daminaide 995 - SuppleFem Sprinkles', 'Materna']

Daminaide 995 - SuppleFem Sprinkles
Materna

['Iron Deficiency', 'Folic Acid Deficiency']


Bioequivalency Study of 450 mg Lithium Carbonate Under Fed Conditions

Summary: The objective of this study was to assess the bioequivalence of two Roxane lithium carbonate 450 mg extended release tablet formulations compared to GlaxoSmithKline's Eskalith CR 450 mg extended release tablet under fed conditions using a single-dose, randomized, three-treatment, three-period, six-sequence crossover design.
Inclusion criteria: inclusion criteria:

 No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion criteria: :

 Participation in a clinicl trial within 30 days prior to study initiation.

 Positive test for HIV, Hepatitis B, or Hepatitis C.

 Treatment with known enzyme altering drugs.


CHF Management Using Telemedicine

Summary: The overall objective of this study is to improve clinical outcomes and quality of life for congestive heart failure (CHF) patients by integrating a readily available, low cost technology - the telephone - into coordinated CHF care.
Inclusion criteria: inclusion criteria:

 Physician diagnosed CHF

 Member of Kaiser Permanente Georgia
Exclusion criteria:


Cortical and Biomechanical Dynamics of Ankle Robotics Training in Stroke

Summary: Reduced mobility is often a long-term problem facing those who have chronic leg weakness resulting from stroke. Recent innovations in stroke therapy have applied motor learning principles to improve motor skills through regular practice of activities using the weaker limb. Because the ankle provides critical torques for normal walking and mobility function, impairments at the affected ankle pose a major limitation to achieving optimal mobility recovery. To address this we have developed a novel ankle robot (Anklebot) to enhance physical therapy for improving walking and mobility after stroke. This computer controlled device provides assistance when users cannot complete a movement, but will not assist if the user is active.~Motor learning requires active involvement in task-related practice to mediate brain plasticity. While voluntary movement is important to remodel motor control circuits, the brain mechanisms of reward and motivation also can play an important role. Core brain networks involved in reward and motivation increase a person's involvement with their surroundings, to focus attention and to prompt one to approach reward and avoid punishment. This increased involvement and the elevated emotions associated with it have been shown to enhance performance, memory and learning.~The purpose of this study is to investigate responses of brain and motor behavior of stroke patients who use the Anklebot during a 3-week / 3-session/week motor learning based training. These responses are compared to a 3-week delayed entry period in which the participants will perform an at-home walking program of equal time. After the 3-week delayed entry walking program, subjects are divided into low and high reward-feedback groups. The low reward-feedback group receives the Anklebot training with only immediate feedback on target successes, without cumulative scores and with minimal social interaction with the researchers. The high-reward group receives cumulative scores and ongoing social support, are eligible for prizes during each session and at the study's completion. All subjects play the games as noninvasive electroencephalography and electromyography record brain and muscle activity. In addition to analyzing brain information before and after the Anklebot training, ankle motor control and walking functions are also assessed immediately before and after the first and last robotic training sessions.
Inclusion criteria: inclusion criteria:

 Ischemic or hemorrhagic stroke greater than 3 months prior

 Residual hemiparetic gait with observable asymmetry in the gait pattern.

 Women or men aged 21 to 85 years

 Completed all conventional physical therapy.

 Adequate language and neurocognitive function to participate in training, testing, and to give informed consent.

 Minimal ankle flexion in either direction (dorsi- or plantar-)

Exclusion criteria: :

 MMSE score < 23 (9th grade education or more) or MMSE score < 17 (8th grade education or less)

 CES-D score > 16

 Clinical history of orthopedic, chronic pain or severe neuromuscular disorders restricting participation in a short term ankle movement training paradigm.

 Severe or global receptive aphasia which confounds reliable testing and training.

 Women of child-bearing potential, if there is any self-reported chance that they may be pregnant.


Carbetocin at Elective Cesarean Delivery

Summary: Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most commonly uterotonic drug used to prevent and treat PPH in North America, however, there are some limitations to its use. Oxytocin has a very short duration of action, which requires a continuous infusion to achieve sustained uterotonic activity. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg dose of carbetocin at elective Cesarean delivery to promote uterine contraction and prevent post partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin lasts 4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater efficacy rate. However, a dose response to determine the minimum effective dose of carbetocin has not yet been published.~We hypothesize that a dose-response study will establish the minimum dose of carbetocin required to produce appropriate contractility in 95% of the women (ED95) undergoing elective cesarean delivery.
Inclusion criteria: inclusion criteria:

 All patients planned for elective cesarean delivery under spinal anesthesia;

 All patients who gave written informed consent to participate in this study.

Exclusion criteria: :

 All patients who refuse to give written informed consent.

 All patients who claim allergy or hypersensitivity to carbetocin or oxytocin.

 All patients with conditions that predispose to uterine atony and postpartum hemorrhage such as placenta previa, multiple gestation, preeclampsia, eclampsia, macrosomia, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, or bleeding diathesis.

 All patients with hepatic, renal, and vascular disease,

 All patients requiring general anesthesia prior to the administration of the study drug.

['Carbetocin', 'Carbetocin', 'Carbetocin', 'Carbetocin', 'Carbetocin']

Carbetocin Carbetocin Carbetocin Carbetocin Carbetocin


Molecular and Clinical Studies of Primary Immunodeficiency Diseases

Summary: This study will try to identify mutations in the genes responsible for primary immunodeficiency disorders (inherited diseases of the immune system) and evaluate the course of these diseases in patients over time to learn more about the medical problems they cause. The immune system is composed of various cells (e.g., T and B cells and phagocytes) and other substances (complement system) that protect the body from infections and cancer. Abnormalities in the gene(s) responsible for the function of these components can lead to serious infections and other immune problems.~Patients with Wiskott-Aldrich syndrome, adenosine deaminase (ADA) deficiency. Participants will undergo a medical and family history, physical examination, and additional procedures and tests that may include the following:~Blood tests for: routine laboratory studies (i.e. cell counts, enzyme levels, electrolytes, etc.); HIV testing; immune response to various substances; genetic testing; and establishment of cell lines to maintain a supply of cells for continued study~Urine and saliva tests for biochemical studies~Skin tests to assess response to antigens such as the viruses and bacteria responsible for tetanus, candida, tuberculosis, diphtheria, chicken pox, and other diseases.~Skin and lymph node biopsies for tissue and DNA studies~Chest X-ray, CT scans, or both to look for cancer or various infections.~Pulmonary function test to assess lung capacity and a breath test to test for H. pylori infection.~Dental, skin and eye examinations.~Treatment with intravenous immunoglobulins or antibodies to prevent infections.~Apheresis for collecting white blood cells to study cell function. In this procedure, whole blood is collected through a needle placed in an arm vein. The blood circulates through a machine that separates it into its components. The white cells are then removed, and the red cells, platelets and plasma are returned to the body, either through the same needle or through a second needle placed in the other arm.~Bone marrow sampling to study the disease. A small amount of marrow from the hipbone is drawn (aspirated) through a needle. The procedure can be done under local anesthesia or light sedation.~Placental and umbilical cord blood studies, if cord blood is available, to study stem cells (cells that form blood cells).~Information gained from this study may provide a better understanding of primary immunodeficiencies, leading to better diagnosis and treatment. In addition, study participants may receive medical and genetic counseling and may be found eligible for other NIH studies on these diseases.
Inclusion criteria: inclusion criteria:

 Patients with a clinical history or signs and symptoms suggestive of a primary immune deficiency syndrome and their family members are eligible for inclusion in this study and they may be referred by their physician or self-referred. If possible, a local physician/clinical immunologist will be identified for self-referred patients to serve as primary reference. If screening of the patients, either by phone interview or review of their medical records indicates that the patient may have a primary immunodeficiency syndrome and is HIV-negative, the patient will be invited to come to the NIH and sign an informed consent. If family history is positive for immunodeficiency, the patients or family members may be asked to invite other relatives to contact the PI to participate in the study.

 Patients who were enrolled under such inclusion criteria may continue to be seen under the protocol under the medical advisory supervision of Dr. Harry Malech. New enrollments will be limited to children with established and verified diagnosis of ADA-SCID cared for by our collaborators at UCLA and from whom we will only

 receive blood samples.

Exclusion criteria: :

 Inability of the subject or the subject s parent/guardian to provide informed consent.

 Patients infected with the Human Immunodeficiency Virus before enrollment.

['Wiskott- Aldrich Syndrome', 'ADA Deficient SCID']

Wiskott- Aldrich Syndrome
ADA Deficient SCID


Brain Mapping of Voice Control

Summary: Some voice disorders are caused by uncontrolled muscle actions that affect the larynx or voice box.~The purpose of this study is to understand 1) how the brain controls voice production; 2) how changes in sensation within the voice box affect brain control of the voice box; 3) how the central nervous system is affected when people have motor or sensory abnormalities that affect the voice box; and 4) whether patients with voice disorders differ from people without voice disorders in the way the brain controls the voice box. By better understanding these concepts, researchers hope to develop improved treatments for patients with voice disorders.~Forty-five healthy adult volunteers and 90 patients with voice disorders will participate in this study. Participants must be between the ages of 20 and 70. The study will involve two visits to the Clinical Center. During the first visit, participants will undergo a medical history and physical exam. During the second visit, investigators will perform the following procedures on study participants: 1) look at the voice box with a nasolaryngoscope, a fine tube through the nose; 2) use MRI [magnetic resonance imaging] to record brain activity while participants use their voice to speak; 3) changing sensation in the voice box by dripping a topical anesthetic onto the vocal folds; and 4) using MRI to again record brain activity during speech immediately after applying the topical anesthetic.~Participants will receive up to $700 in compensation for their involvement in this study.
Inclusion criteria: inclusion criteria:

 The inclusion criteria for normal volunteers are normal vocal function and average health as determined by the staff otolaryngologist. Normal vocal function refers to normal voice quality, a negative history for voice or laryngeal disorders. Persons with significant pulmonary, neurological and psychiatric function will not be recruited. The primary inclusion criteria for the voice disordered groups are a current diagnosis of spasmodic dysphonia (abductor or adductor type), muscular tension dysphonia or voice tremor. These persons will not have pulmonary, neurological or psychiatric disorders or
Exclusion criteria: .

 inclusion criteria - for Patients with Spasmodic Dysphonia:

 Intermittent strained hoarseness, uncontrolled voice breaks or changes in pitch are present during vowels, liquids (r & l) and semi-vowels (w & y), during speech for adductor SD or prolonged voiceless consonants producing breathy breaks for abductor SD;

 Less prominent symptoms during whisper, singing or falsetto,

 Normal voice and vocal fold movement for protective and emotional laryngeal function, such as cough, laugh or cry;

 A diagnosis of adductor or adductor spasmodic dysphonia based on voice testing and fiberoptic nasolaryngoscopy by a board certified otolaryngologist and Speech-Language Pathologist during the initial interview;

 Exclusion of other laryngeal pathologies based on a fiberoptic nasolaryngoscopic examination conducted during the initial interview by the staff otolaryngologist.

 inclusion criteria - for Patients with Muscular Tension Dysphonia:

 Increased phonatory muscle tension in the paralaryngeal and suprahyoid muscles on palpation;

 A consistent hypertonic laryngeal posture for phonation, such as either an anterior-posterior squeeze (pin-hole posture) or ventricular hyper adduction and an absence of SD or vocal tremor as determined by a Speech-Language Pathologist and the staff otolaryngologist;

 Exclusion of other laryngeal pathologies based on a fiberoptic nasolaryngoscopic examination conducted during the initial interview by the staff otolaryngologist.

 inclusion criteria - for Patients with Vocal Tremor:

 Vocal tremor during vocalization that primarily involves laryngeal structures;

 Exclusion of other laryngeal pathologies based on a fiberoptic nasolaryngoscopic examination conducted during the initial interview by the staff otolaryngologist.


Tick-borne Illness and Clothing Study of Rhode Island

Summary: Lyme and other tick-borne diseases pose a significant health threat to outdoor workers. This study is a double-blind randomized controlled trial of outdoor workers in Rhode Island and the surrounding area that will address the following study aims: 1) Evaluate the effectiveness of LLPI clothing in preventing tick bites among outdoor workers in Lyme endemic areas; 2) Measure the urine levels of permethrin metabolites in study subjects; and 3) Measure the loss over time of knockdown activity against ticks and of permethrin in LLPI clothing.
Inclusion criteria: inclusion criteria:

 over 18 years of age,

 spending an average of 10 or more hours of outdoor work per week during peak tick season, and

 completion of written informed consent.

Exclusion criteria: :

 pregnancy or a planned pregnancy during the follow-up period (since exposure to an insecticide is involved),

 non-English speakers, or

 having a known allergy or sensitivity to insecticides


Cold Snare Polypectomy Versus. Endoscopic Mucosal Resection

Summary: The investigators will investigate the efficacy of EMR compared to CSP in treatment of small colon polp (6~10mm).~One aim of this study was to investigate the necessity of EMR on resection of small colon polyp.
Inclusion criteria: inclusion criteria:

 All those over the age of 20 years who agree informed consent and who have at least one polyp of eligible size (6-10 mm)

Exclusion criteria: :

 (1) patients taking anticoagulant therapy during the past 1 week of the procedure, (2) known coagulopathy, (3) history of liver cirrhosis, chronic kidney disease, malignancy, inflammatory bowel diseases or significant infectious disease, (4) American Society of Anesthesiology class III or more, and (5) pedunculated polyps and polyps with malignant feature.


Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease

Summary: Cardiovascular disease is the most common cause of death in the world. Most of the attention in treating ischemic heart disease (IHD) is understandably directed toward treating coronary artery disease. However there are other treatable culprits in these patients.~Left ventricular hypertrophy (LVH) is widespread in IHD patients, even in the absence of hypertension. It is a strong predictor of cardiovascular events and all-cause mortality. In one study, the presence of LVH was a stronger predictor of mortality than either multivessel cor-onary disease or impaired LV function.~Metformin is an antihyperglycemic agent with a history of successful use in type 2 diabetes. In the UKPDS (United Kingdom Prospective Diabetes Study), metformin was associated with a 39% lower risk of myocardial infarction compared with conventional therapy. Metformin also offered dual benefits of improving vascular function and lessening ischemia in nondiabetic patients.~Hence, the main aim of this study was to assess whether metformin could regress LVM in patients with IHD. The secondary aim was to assess the effect of metformin on LV volumes and endothelial function in this patient group.
Inclusion criteria: inclusion criteria:

 They had to have normal glucose tolerance.

 They had to have either angiographically documented coronary artery disease or a previous history of myocardial infarction.

 They were required to have an office BP < 130/80 mm Hg

 The presence of LVH on echocardiography (American Society of Echocardiography criteria LVM index [LVMI] > 115 g/m2 for men and > 95 g/m2 for women).

Exclusion criteria: :

 They were currently prescribed metformin.

 They had renal and liver dysfunction, heart failure, or malignancy, or were unable to give informed consent.

 Patients with contraindications to cardiac magnetic resonance (CMR) (pacemakers, claustrophobia) were also excluded, as were pregnant or lactating women.


A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients

Summary: To determine safety, tolerability and preliminary efficacy of intraglandular injections of MYOBLOC for the treatment of sialorrhea in Parkinsons' Disease patients
Inclusion criteria: inclusion criteria:

 Parkinsons' Disease patients with Sialorrhea for at least 3 months

Exclusion criteria: :

 Patients with non-idiopathic PD parkinsonism

 Patients previously exposed to botulinum toxins

 Patients with a history of aspiration pneumonia, moderate/severe choking and/or moderate/severe dysphagia

 Patients with prior salivary gland surgery

['Botulinum Toxin Type B (Myobloc)', 'Matched placebo to Myobloc']

Botulinum Toxin Type B (Myobloc)
Matched placebo to Myobloc


Shared Decision Making in Parents of Children With Head Trauma: Head CT Choice

Summary: The investigators will test the impact of a decision aid, Head CT Choice, to determine if its use improves parents' knowledge and engagement in decision making and safely decreases healthcare utilization in children presenting to the emergency department with blunt head trauma.
Inclusion criteria: inclusion criteria:

 Parents and their child, seeking care for a child who:

 Is < 18 years of age;

 Had blunt trauma above the eyebrows (not isolated to face or eyes);

 Is positive for at least 1 of the PECARN clinical prediction rule predictors described below:

 PECARN Predictors for children < 2 years of age:

 Severe mechanism (PECARN definition)* Loss of consciousness > 5 seconds Acting abnormally per parent Initial ED GCS < 15 by attending (or CT decision-maker) Other signs of altered mental status (PECARN definition) Presence of occipital, temporal or parietal scalp hematoma Palpable skull fracture or unclear if skull fracture

 PECARN predictors for children 2-18 years of age:

 Severe mechanism (PECARN definition)* Any loss of consciousness Any vomiting since the injury Severe headache in ED Initial ED GCS < 15 by attending (or CT decision-maker) Other signs of altered mental status (PECARN definition)** Any sign of basilar skull fracture Clinicians include attending physicians and fellows or midlevel providers caring for children with head trauma

Exclusion criteria: :

 Parents of children with:

 GCS scores < 15

 Evidence of penetrating trauma, signs of basilar skull fracture, or depressed skull fracture on physical examination

 Brain tumors

 Ventricular shunts

 Bleeding disorder

 Pre-existing neurological disorders complicating assessment

 Neuroimaging at an outside hospital before transfer

 Signs of altered mental status (agitation, somnolence, repetitive questioning, or slow response to verbal communication)

 Syncope or seizure disorder preceded (led to) head trauma or seizure post head trauma

 Known to be pregnant

 Communication barriers such as visual or hearing impairment that may preclude use of the decision aid.

 Strong suspicion of abuse for this head injury


Summary: The purpose of this study is to Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.
Inclusion criteria: inclusion criteria:

 Healthy Children:

 Male or female age greater than/equal to 6 months or less than/equal to 36 months old.

 Parent/guardian willing to bring to all study visits

Exclusion criteria: :

 Any major illness/condition that in investigator opinion would put subject at risk during study.

 Otorrhea or tympanostomy tubes present in either ear @ time of enrollment.

 Direct descendant of study site personnel.

 Subjects < 6 months old or >36 months old at the time of enrollment

['Nasopharyngeal Colonization and Acute Otitis Media']


Summary: Heart failure, a chronic illness afflicting 5 million persons in the United States is known to cause shortness of breath and fatigue, yet at least half of persons with heart failure also report the presence of pain.~The cause of pain for these persons is not clear. PAIN-HF (Pain Assessment, Incidence & Nature in Heart Failure), conducted through the Palliative Care-Heart Failure Education And Research Trials (PC-HEART) collaborative will identify the prevalence of pain, its location, severity and impact on activities and the possible causes of pain in persons living with heart failure. The study will also try to understand relationships between other problems and pain, as well as what treatments are given to reduce pain.~Understanding sources of pain and its characteristics is the first step in helping health care providers better manage pain and related problems in persons with heart failure.
Inclusion criteria: inclusion criteria:

 Advanced HF (Stage D or advanced Stage C HF) with:

 symptoms of dyspnea at rest or with minimal exertion systolic dysfunction or preserved systolic function (diastolic heart failure) Outpatient care setting (office, clinic or home hospice).

 Patient already receiving optimal medical therapy per ACC/AHA guidelines (ACEI or ARB + β-blocker +aldosterone antagonist) for at least 1 month or explanation of intolerance of specific medication. We will exclude those not on optimized medications with no notation of intolerance; however, we will keep a tally to quantify patients who are considered advanced Heart Failure but are not on recommended medications.

 Can be awaiting LVAD, transplantation or other procedure

 Age > 18 years and able to sign informed consent to participate

Exclusion criteria: :

 Cognitive or other impairment which prevents accurate assessment of symptoms or ability to provide informed consent.

 Heart failure due to recent onset of acute viral myocarditis, peripartum myocarditis.

 Patient on hemodialysis or receiving mechanical ventilation

 Patients receiving investigational agents or devices.

 Patients who have received heart transplant or a destination Left Ventricular Assist Device


HPV Testing for Cervical Cancer Screening Study

Summary: This is a randomised controlled trial of HPV testing with cytology triage for HPV positive women compared to liquid-based cervical cytology (LBC). Although LBC is not widely used for cervical cancer screening in Canada at present, the Pan-Canadian Cervical Cancer Forum has recommended its use and as it is likely to be the standard of care by the time these data are published, the trial has been designed to account for this. Further, LBC will improve the cost-effectiveness of HPV testing because the LBC medium is suitable for both HPV testing as well as cytology and thereby allows the triage testing to be undertaken from the same sample without having to recall the women.
Inclusion criteria: inclusion criteria:

 Women from 25 to 65 years of age, registered with the Medical Services Plain in BC attending a collaborating healthcare provider for routine cervical screening in Metro Vancouver or Greater Victoria.

Exclusion criteria: :

 pregnant

 history of invasive cervical cancer

 no cervix

 HIV positive or on immunosuppressive treatments

 unable or unwilling to give informed consent

 Treatment of moderate or greater dysplasia within last 5 years

['Cervical cancer screening undertaken by HPV testing as a single primary screening test with cytology triage of women who are HPV positive', 'Cervical cancer screening undertaken by HPV testing as a single primary screening test with cytology triage of women who are HPV positive']