Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale (DEFENSE-PFO)

Summary: Background and hypothesis:~The appropriate treatment strategy for secondary stroke prevention in patients with cryptogenic stroke and patent foramen ovale (PFO) remains challenging. Clinical and anatomical variables reported to be risk factors associated with stroke recurrence include older age, large PFO, large right-to-left shunting, and combined atrial septal aneurysm (ASA), which, however, were not confirmed by other studies. The investigators hypothesized that percutaneous closure of PFO could be an effective option for secondary prevention in cryptogenic stroke patients with high-risk PFO.~Trial Objective:~The primary objective of this study is to assess whether percutaneous device closure of PFO is superior to conventional antithrombotic treatment in preventing stroke recurrence in the cryptogenic stroke patients with high-risk PFO.
Inclusion criteria: inclusion criteria:

 Subjects who have had a cryptogenic stroke within the previous 3 months, radiologically verified

 Subjects who have been diagnosed with a high-risk* Patent Foramen Ovale (PFO), echocardiographically verified (*PFO size ≥ 2 mm or atrial septal aneurysm or hypermobility by TEE)

 Subjects willing to participate in follow-up visits

 Absence of other potential causes of stroke

Exclusion criteria: :

 Any identifiable cause of thromboembolic cause other than PFO

 Subjects with intracardiac thrombus or tumor, dilated cardiomyopathy, prosthetic heart valve or mitral stenosis, endocarditis

 Subjects with significant atherosclerosis or dissection of the aorta, collagen vascular disease, arteritis, vasculitis and coagulopathy

 Subjects who have an acute or recent (within 6 months) myocardial infarction or unstable angina

 Subjects who have a non-vascular origin of the neurological symptoms after brain imaging (CT scan or MRI)

 History of intracranial bleeding, confirmed arterio-venous malformation,aneurysm or uncontrolled coagulopathy

 Pre-existing neurological disorders or intracranial disease, e.g. multiple sclerosis

 Subjects with left ventricular aneurysm or akinesis

 Subjects with atrial fibrillation/atrial flutter (chronic or intermittent)

 Subjects with another source of right to left shunt identified at baseline, including an atrial septal defect and/or fenestrated septum

 Subjects who could not undergo the TEE examination

 Subjects with contraindication to aspirin or Clopidogrel therapy

 Pregnant or desire to become pregnant within the next year

 Subjects who have a underlying malignancy

['Device closure', 'Standard medical treatment']

Device closure
Standard medical treatment


Hypoalgesic Effects Neural Mobilization Techniques

Summary: The purpose of this study was to evaluate the immediate mechanical hypoalgesic effect of neural mobilization in asymptomatic subjects. We also compared neural gliding versus neural stretching to see which produced greater hypoalgesic effects in asymptomatic subjects.
Inclusion criteria: inclusion criteria:

 Asymptomatic subjects who met the inclusion criterion of being between 18 and 30 years old.

Exclusion criteria: :

 rheumatologic diseases or any type of cancer, cervical surgery in the past, whiplash trauma and undergoing any type of treatment like physical therapy, manual therapy, osteopathy, chiropraxis, acupuncture during the last three months. All patients recruited for the study complained of pain localized in the neck and/or head region. Initial screening was accomplished by telephone and eligible persons attended a evaluation appointment.

 development of systemic or degenerative diseases

 subjects with symptoms of depression according Beck's questionnaire

 pain in any area between the lower back and head in the last 9 months

 traumatic event in the past 12 months

 history of neck or face pain in the last 6 months


Cerebrospinal Fluid Levels of Erlotinib in Patients Receiving Erlotinib For Stage III Non-Small Cell Lung Cancer

Summary: RATIONALE: Determining whether erlotinib passes into the cerebrospinal fluid may help in planning treatment for some types of cancer.~PURPOSE: This clinical trial is studying how well erlotinib is able to pass into the cerebrospinal fluid of patients receiving erlotinib for stage III non-small cell lung cancer.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Patients must be enrolled in the trial: A Phase I/II Trial of Neoadjuvant Paclitaxel, Carboplatin and OSI-774 (Tarceva) with Concurrent Accelerated Hyperfractionation Radiation Followed by Maintenance Therapy with OSI-774 for Stage III Non-Small Cell Lung Cancer, Principal Investigator: T. Mekhail, M.D.

 Patient must be in maintenance therapy phase of the study and have received erlotinib for ≥ 1 week

 No known CNS primary or metastatic cancer at any time prior to time of enrollment

 No MRI evidence of pathological enhancement at the time of study entry

 PATIENT CHARACTERISTICS:

 Patients must use adequate birth control measures while in the study

 No significant side effects to erlotinib that require dose reduction or interruption

 None of the following medical issues which could make a lumbar puncture unsafe:

 Platelets < 100,000/mm³

 INR > 1.1

 Known bleeding dyscrasia

 Absolute neutrophil count < 1,500/mm³

 Ongoing systemic bacterial infection

 PRIOR CONCURRENT THERAPY:

 Patients on modest or anti-epileptic therapy must be on nonenzyme-inducing drug only, including any of the following:

 Neurontin

 Lamictal

 Depakote, Depakene

 Felbatol

 Keppra

 Gabitril

 Topimax

 Zonegran

 No concurrent enzyme-inducing anti-epileptic drugs such as phenytoin, carbamazepine, or phenobarbital

 No concurrent other drug known to affect the metabolism of erlotinib

 No concurrent anticoagulant therapy
Exclusion criteria:


BHCG Level in Day 4,7, in Comparison to Day 10 as an Indicator for Treatment Success

Summary: The investigators want to compeer BHCG levels after Methotrexate ( MTX). treatment for Ectopic pregnancy in days 4 and 7 after MTX. to day 10 . The hypothesis is that BHCG level in day 10 is the best indicator for treatment success , superior to day 4 and 7 . According to the investigators impression BHCG level rises in days 4 and 7 due to destruction of the trophoblast tissue , and only day 10 is an indicator for treatment success
Inclusion criteria: inclusion criteria:

 patients with ectopic pregnancy

 healthy

 hemodynamic stable

 first ectopic

Exclusion criteria: :

 hemodynamic non-stable

 abnormal liver or kidney function

 allergy reaction to MTX


Peptic Ulcer Perforation Study

Summary: The objective of this study is to implement an optimized perioperative course for patients surgically treated for peptic ulcer perforation in order to improve the outcome for these patients.~The optimized perioperative course consists of a number of interventions carried out before, during and after surgery.
Inclusion criteria: inclusion criteria:

 Patients surgically treated for benign peptic ulcer perforation

Exclusion criteria: :

 Age < 18 years

 Pregnant and breastfeeding women

 Malign ulcer perforation


High Dose CVVHDF Compared to Standard Dose CVVHDF

Summary: In the last three decades, the mortality associated with acute renal failure (ARF) in the ICU has remained unchanged at greater than 50%, despite improvements in dialysis technology.~The primary objective is to determine whether Continuous Veno-Venous Hemodiafiltration (CVVHDF) using an ultrafiltration rate of 35 ml/hr/kg (high dose) leads to a greater reduction in all-cause ICU mortality compared to standard CVVHDF using an ultrafiltration rate of 20 ml/hr/kg.
Inclusion criteria: inclusion criteria:

 Male or female > or equal to 19 yrs of age

 ARF defined by at least one of the following:

 Volume overload from inadequate urine output despite diuretic agents.

 Oliguria (urine output < 200 ml/12hrs) despite fluid resuscitation and diuretic administration.

 Anuria (urine output < 50 ml/12 hrs).

 Acute azotemia (BUN > or equal to 80 mg/dl).

 Acute hyperkalemia not responsive to medication (K+ > or equal to 6.5mmol/L)

 An increase in serum creatinine of > 2.5 mg/dl from normal values or a sustained rise in serum creatinine of > or equal to 1 mg/dl over baseline.

Exclusion criteria:

 Patients with end stage renal disease

 Patients who have had more than one previous dialysis session for acute or chronic renal failure during the current hospitalization

 Patient weight greater than 125 kg

 Patient weight less than 50 kg

 Pregnancy

 Prisoner

 Non-candidacy for continuous renal replacement therapy (CRRT)

 Patient/surrogate refusal

['Standard dose of dialysis', 'High dose of dialysis']

Standard dose of dialysis
High dose of dialysis


Use of PiCCO System in Critically Ill Patients With Septic Shock and Acute Respiratory Distress Syndrome

Summary: PiCCO has been widely used in critical care settings for several decades. Together with pulmonary artery catheter, it is regarded as the important tool for guiding fluid management in patients with shock or acute respiratory distress syndrome. However, its effects on patients' outcome remain untested. The investigators study is a pilot study that is designed to test whether the use of PiCCO will improve patients' outcome, as compared to those without PiCCO monitoring.
Inclusion criteria: inclusion criteria:

 Patients were included if they were diagnosed with Shock, Acute respiratory distress syndrome (ARDS), or both.

 Shock was defined by the presence 4 criteria:

 Heart rate of at least 90/min;

 A respiratory rate of at least 20/min or a PaCO2 of 32mmHg or lower or the use of mechanical ventilation;

 The use of vasopressors to maintain a systolic blood pressure of at least 90mmHg despite fluid resuscitation, low dose of dopamine (≤ 5 μg/kg per minute), or dobutamine;

 at least 1 of 3 signs of hypoperfusion (urine output < 0.5mL/kg of body weight per hour for 1 hour or more; neurologic dysfunction defined by confusion, psychosis, or a Glasgow coma scale score of ≤ 6; plasma lactate higher than the upper limit of the normal value).

 Acute respiratory distress syndrome：

 the presence of acute decrease in PaO2/FIO2 to 200mmHg or lower,

 bilateral pulmonary infiltrates or a chest radiograph consistent with edema;

 no clinical evidence of left atrial hypertension; and requirement for positive pressure ventilation.

Exclusion criteria: :

 Patients were moribund.

 signed do-not-resuscitation odor.

['PiCCO monitoring (PULSION)', 'central venous catheter']

PiCCO monitoring (PULSION)
central venous catheter

['Septic Shock', 'Acute Respiratory Distress Syndrome']

Septic Shock
Acute Respiratory Distress Syndrome


Effect of Post Discharge Follow-up on Readmission Rates for Congestive Heart Failure Patients

Summary: The purpose of this study is to test the hypothesis that a comprehensive post-discharge disease management system is more effective in reducing the readmission rate for heart failure patients compared to standard care.
Inclusion criteria: inclusion criteria:

 Age =/or >18

 Admitted to the Heart Failure Unit with acute decompensated heart failure

 Referred to the Congestive Heart Failure Disease Management Program

Exclusion criteria: :

 Age<18

 Mentally incapacitated

 Discharge to a skilled nursing facility

['Congestive Heart Failure', 'Systolic Dysfunction']

Congestive Heart Failure
Systolic Dysfunction


Comparison of Prophylactic Clip and Detachable Snare

Summary: Although endoscopic colonic polypectomy has been an established procedure for two decades, the risk of bleeding is still higher after resecting of pedunculated polyps, because of the presence of a large artery in the stalk. Several preventive methods such as detachable snare and adrenaline injection have been proposed in the management of postpolypectomy bleeding in large colonic polyps. For prophylactic clip, there was no prospective randomized study assessing the efficacy in the prevention of postpolypectomy bleeding for the large pedunculated polyps. So we designed a prospective, randomized study to compares the efficacy of application of prophylactic clip and detachable snare in the prevention of postpolypectomy bleeding in large polyps. Application of prophylactic clip will be as effective and safe method as detachable snare in the prevention of postpolypectomy bleeding for the large pedunculated colonic polyps.
Inclusion criteria: inclusion criteria:

 Patients with pedunculated colorectal polyps, the heads of which were larger than 10mm and the stalk of which were large than 5 mm in diameter, were included.

Exclusion criteria: :

 bleeding tendency

 poor preparation

 sessile polyp

['Prophylactic clip', 'Detachable snare']


Study of Non Inferiority Bi-Profenid® 200mg Versus Bi-Profenid® 300mg Among Patients Presenting of the Post-traumatic or Rheumatologic Acute Affections of the Locomotor Apparatus (BIPROPAIN)

Summary: Primary objective:~To demonstrate the non-inferiority of Bi-Profenid 100 mg x 2 day versus Bi-Profenid 150 mg x 2 day in patients presenting with pain related to closed, benign, acute post-traumatic conditions of the motor system or acute, non-infectious rheumatologic conditions, by comparing, on the one hand, changes in resting pain intensity over the entire day, measured at the end of the day using a numeric scale (NS), over 5 days and, on the other hand, total intake over 5 days of concomitant analgesics.~Secondary Objectives:~To describe concomitant analgesic treatments~To describe the time between baseline and use of a step I, II or III analgesic~To evaluate patients pain relief using a Likert 4-class scale (complete or substantial relief, moderate relief slight relief and absence of relief) at D5~To evaluate changes in intensity of pain when moving, over the entire day, measured at the end of the day using a numeric scale, over 5 days~To evaluate the patients overall satisfaction at the end of treatment using a 4-point Simple Verbal Scale (SVS) (very satisfied, somewhat satisfied, somewhat unsatisfied, very unsatisfied)~To evaluate the patients overall satisfaction at the end of the study using a 4-point Simple Verbal Scale (EVS) (very satisfied, somewhat satisfied, somewhat unsatisfied, very unsatisfied)~To compare the safety of the two treatments
Inclusion criteria: inclusion criteria :

 Male or female, more than 18 and less than 65 years of age,

 Women using a method of contraception and with a negative pregnancy test before entering the study, or women who have been menopausal for at least 1 year,

 Patients meeting one of the following criteria:

 Closed benign trauma of the motor system occurring within the last 24 hours,

 Contusion of the motor system occurring within the last 24 hours,

 Acute rheumatologic conditions (acute lower back pain, lumbar sciatica, cervicobrachial neuralgia),

 Abarticular rheumatism,

 Requiring treatment with Bi-Profenid for 5 days,

 With resting pain intensity measured on a numeric scale at baseline >or= 3 (before administration of any treatment),

 Receiving a prior medical examination suited to the study

Exclusion criteria:  :

 Need for surgery,

 Need for hospitalization,

 Need for an analgesic other than step I at the baseline visit,

 Need for treatment with another selective or non-selective NSAID (per os and/or topical), including aspirin, selective cyclo-oxygenase 2 inhibitors, corticosteroids or muscle relaxants at baseline and throughout the study,

 Serious trauma: knee luxation, any fracture, ruptures such as Achilles tendon rupture,

 Sprain treated with a cast,

 Bursitis,

 Local and/or general severe infection,

 Pregnant or nursing women,

 Hypersensitivity to ketoprofen or to any of the excipients of the product,

 Previous history of asthma triggered by taking ketoprofen or substances with similar activity such as other NSAIDs or aspirin,

 Gastrointestinal haemorrhage, cerebrovascular haemorrhage or other active haemorrhage,

 Previous history of digestive haemorrhage or perforation during previous NSAID treatment,

 Active intestinal ulcer,

 Active peptic ulcer, previous history of peptic ulcer or recurrent haemorrhage (2 separate episodes or more of haemorrhage or ulcerations detected),

 Severe hepatic failure,

 Severe renal failure,

 Severe heart failure,

 Uncontrolled hypertension,

 Hypersensitivity or intolerance to gluten, due to the presence of wheat starch (gluten),

 Patients treated with oral anticoagulants, heparins, platelet antiaggregants, selective serotonin reuptake inhibitors (SSRI), lithium, methotrexate, pemetrexed and immunosuppressants

 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Effectiveness of Two Treatments on Posture and Balance in Elderly Women With Osteoporosis

Summary: The purpose of this study was compare the efficacy of two exercise programs - the first consisting of balance training and muscle strength and the second consisting of balance training and muscle stretching exercises - to improve postural control in elderly women with osteoporosis.
Inclusion criteria: inclusion criteria:

 women from 65 to 80 yrs of age

 diagnosis of osteoporosis classified according to the criteria of the World Health Organization, with bone mineral densitometry reduced by at least 2.5 SD when compared with young adults (region of lumbar spine)

Exclusion criteria: :

 severe visual deficiency

 physically incapable of participating in the tests

 neurological disorders, amputations, or prostheses

 individuals with regular physical activity (twice or more per week) or who had recently participated in exercise programs for muscular strength or balance

['Strengthening and balance exercises', 'Stretching and balance exercises']

Strengthening and balance exercises
Stretching and balance exercises


Radiofrequency Ablation for Liver Abscesses From Chronic Granulomatous Disease

Summary: Background:~- Abscesses are a pocket of infection in an organ or tissue. Patients with a disease called chronic granulomatous disease (CGD) often develop these abscesses. CGD is an inherited disorder that affects how white blood cells function. Liver abscesses in people with CGD often require surgery to remove them and treat the infection. However, some people with CGD cannot have full surgery because it would be too risky. Researchers want to try a procedure called radiofrequency ablation (RFA) to treat these liver abscesses. RFA can usually be done without a major operation. This study will see if RFA is a safe and effective treatment for liver abscesses in patients with CGD.~Objectives:~- To see if RFA is a safe and effective treatment for CGD-related liver abscesses.~Eligibility:~- Individuals between 18 and 75 years of age with CGD who have liver abscesses that cannot be treated with surgery.~Design:~Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies will be performed on the liver.~Participants will have RFA for the abscesses. RFA is an image-guided technique that heats and destroys specific tissue, such as tumor tissue. It will target any abscesses on the liver.~After the procedure, participants will stay in the hospital for monitoring before being released.~Participants will have regular follow-up visits for up to 1 year after treatment. Blood and urine samples will be collected. Additional imaging studies will be performed.
Inclusion criteria: INCLUSION/ELIGIBILITY CRITERIA:

 A patient will be included if he or she meets all of the following criteria:

 Has documented chronic granulomatous disease

 Age 18 - 75

 Has a liver abscess infected with Staphylococcus aureus or other microorganism susceptible to RFA, but is not an optimal candidate for curative surgical resection either due to location of disease, multiplicity of disease, or previous surgery or other comorbidities, such as pulmonary insufficiency, or has other contraindications to general anesthesia or perioperative management or refuses surgery.

 Is willing to return to NIH for imaging scans

 Is willing to undergo testing or procedures associated with this protocol

 Has failed long term antibiotic treatment and abscess drainage if applicable.

Exclusion criteria: :

 A patient will be excluded if he or she satisfies 1 or more of the following criteria:

 Positive results for toxin-producing bacteria obtained from liver biopsy in the pertinent abscess.

 Is a good candidate for liver-curative open surgical resection and does not refuse the surgery.

 Is not a candidate for RFA therapy due to lesion size or location.

 Has a prothrombin time (PT) or partial thromboplastin time (PTT) >1.5 times normal (except in patients who have a known lupus anticoagulant or other condition which a hematologist deems will not cause excessive bleeding despite the abnormal coagulation parameters).

 Has a platelet count <50,000/mm(3) which cannot be maintained despite platelet transfusions.

 If you are pregnant.

 Any condition that, in the investigator s opinion, places the patient at undue risk by participating in the study

 Please Note: Co-morbidities in critically ill patients will not themselves constitute

['Chronic Granulomatous Diseases (CGD) and Liver Lesions']


Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers

Summary: This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel cohorts of diabetic patients with at least 1 infected foot ulcer. Patients will be randomized to receive 1 of 3 study treatments; systemic antibiotic therapy and standard ulcer care with either (A) daily application of a gentamicin-sponge, (B) daily application of a placebo-sponge or (C) no-sponge, in the ratio 2:1:1. Patients will be treated for approximately 28 days and return to the clinic weekly for safety and efficacy assessments. After completing treatment, patients will return to the clinic for scheduled follow-up visits approximately 10, 30, 60 and 90 days after treatment is stopped.
Inclusion criteria: Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria.

 Has at least 1 skin ulcer located on or below the malleolus that presents with the following clinical manifestations of a moderate or severe infection based on the Infectious Disease Society of America guidelines for the Diagnosis and Treatment of Diabetic Foot Infections (CID 2012; 54:132-173) (IDSA guidelines):

 has ≥ 2 manifestations of inflammation (local swelling or induration, erythema, local tenderness or pain, local warmth, purulent discharge (thick, opaque to white or sanguineous secretion)

 has ≥ 1 of the following characteristics: erythema > 2cm, or involving structures deeper than skin and subcutaneous tissues (e.g. abscess, osteomyelitis, septic arthritis, fasciitis) For patients with multiple infected ulcers, the ulcer with the highest Diabetic Foot Infection Wound score (DFI score) must be on or below the malleolus and all infected ulcers must be completely coverable using no more than 4 sponges (sponges cannot be cut).

 Has documented adequate arterial perfusion in the affected limb(s) (either palpable dorsalis pedis and posterior tibial pulses, or normal Doppler wave forms, a toe blood pressure ≥ 45 mm Hg or participation is approved by a vascular surgeon)

 Has received appropriate surgical intervention to remove all necrotic and infected bone if diagnosed with osteomyelitis.

 Has received appropriate surgical debridement to remove all gangrenous tissue.

Exclusion criteria: :

 Has a known history of hypersensitivity to gentamicin (or other aminoglycosides).

 Has a known or suspected hypersensitivity to bovine collagen.

 Has an ulcer infection which, based upon the patient's known history of hypersensitivity and/or as otherwise in the opinion of the investigator, cannot be adequately treated with at least one of the empiric systemic antibiotic regimens allowed by this protocol.

 Has an ulcer associated with prosthetic material or an implanted device.

 Has received any systemic or topical antibiotic therapy for any reason within 7 days of randomization unless it was administered to specifically treat the infected ulcer(s) and only within 36 hours of randomization.

 Requires or is likely to require treatment with any concomitant topical product or wound therapy before the first follow-up study visit.

 Is severely immunocompromised, or likely to become severely immunocompromised during the study, in the opinion of the investigator.

 Has a history of myasthenia gravis or other neurological condition where gentamicin use is contraindicated as determined by the investigator.

 Has a history of epilepsy.

 Has a history of alcohol or substance abuse in the past 12 months.

 Has an uncontrolled illness that, in the opinion of the investigator, is likely to cause the patient to be withdrawn from the trial or would otherwise interfere with interpreting the results of the study

['Gentamicin Collagen sponge', 'Placebo']


Demographic, Clinical and Laboratory Characteristics of Children With Alpha Thalassemia in Northern Israel

Summary: The study intends to summarize the clinical and laboratory characteristics of children with hemolytic anemia diagnosed as having alpha thalassemia mutations.
Inclusion criteria: inclusion criteria:

 All the patients that were studied at the pediatric hematology unit ant the Ha'Emek Medical Center

Exclusion criteria: :

 None

['Thalassemia Alpha', 'Hemolytic Anemia']


Neuromuscular Balance in Low Back Pain

Summary: The research was an interventional study with a quantitative board, fulfilled in a private clinique specialized in trauma service; it was formed between august to October of 2006. The objective was to investigate the effectiveness of neuromuscular balance in lumbar pain. The 12 patients, with age between 20 and 55 years, whose did five consultations, with 100% presence, got relief of the pain and increase of movement of hips' articulation which was the most painful movement with 91,66% graduation. All the patients presented the shorting test positive and it kept positive in 7 patients. There was a significant improvement in pain relief (p=0,001,) comparing the first and the fifth consultation, and hip articulation movement. Even after the relief of the pain, 7(58,3%) of the patients kept the treatment for a more effective rehabilitation and prevention of repetition of the symptoms. It was concluded that the neuromuscular balance relieved quickly the pain, being essential for effective rehabilitation of low back pain, with the inclusion of others manual techniques.
Inclusion criteria: inclusion criteria:

 Patients with low back pain between 20 and 55 years old, submitted to a physical therapy treatment.

Exclusion criteria: :

 Patients with no miofascial low back pain


Efficacy of Ramelteon on Speeding Up Sleep in Subjects With Delayed Sleep Phase Syndrome

Summary: The purpose of this study is to evaluate the ability of ramelteon, once daily (QD), to advance the timing of sleep in individuals with delayed sleep phase syndrome.
Inclusion criteria: inclusion criteria:

 Females of childbearing potential who is sexually active must agree to use adequate contraception from screening throughout the duration of the study.

 Must have a diagnosis of Delayed Sleep Phase Syndrome according to International Classification of Sleep Disorders criteria for at least 3 months.

 Based on sleep history, subject's habitual sleep time is more than 3 hours later than the desired sleep time.

 Must have had self reported insomnia which is defined per the sleep history as his or her sleep latency of at least 45 minutes when attempting to sleep at desired sleep time required by his or her work or school schedule.

 The subjective sleep latency via Post sleep questionnaire during outpatient screening period must be greater than or equal to 45 minutes during every working night or school night provided the subject went to bed at their desired sleep time.

 During single blind placebo run-in Polysomnography screening nights, subject is instructed to go to bed at their desired bed time and must demonstrate difficulty in falling asleep based on the following criteria:

 During Polysomnography screening nights when the subject goes to bed at their desired sleep time or

 The average of total wake time

 Is in good health as determined by a medical and psychiatric history, physical examination, Electrocardiogram, and serum chemistry and hematology.

 Is able to complete self-rating scales via interactive voice response system, and has a touch tone phone.

 Is willing to comply with study procedures and restrictions with fixed sleep time and wake time during the study and to attend regularly scheduled clinic visits as specified in this protocol.

 Has a body mass index is between 18 and 34 kg/m2, inclusive.

 Has a negative urine test result for selected substances of abuse (including alcohol).

 Has a negative test result for hepatitis B surface antigen and hepatitis C virus antibody or history of human immunodeficiency virus.

 Has not used pharmacological sleep assistance for more than 4 times/week during the 3 months prior to Initial Screening.

 Must have discontinued use of all pharmacological sleep aids beginning 1 week prior to Visit 2 and for the duration of the trial.

Exclusion criteria: :

 Has a known hypersensitivity to ramelteon or related compounds, including melatonin and melatonin-related compounds or 5-hydroxytryptophan.

 Has participated in any other investigational study and/or taken any investigational drug within 30 days or 5 half-lives prior to the first dose of study medication, whichever is longer.

 Has flown across greater than 3 time zones within the past 3 months prior to administration of study medication.

 Has sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the administration of study medication.

 Has participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the administration of study medication.

 Has a history of alcohol abuse within the past 12 months, as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, or regularly consumes more than 14 alcoholic drinks per week or consumes any alcoholic drinks within 24 hours of Screening Visit.

 Has a history of drug abuse within the past 12 months.

 Has a current, clinically significant neurological (including cognitive), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease, as determined by the investigator.

 Has a probable current diagnosis of another circadian rhythm disorder or a sleep disorder other than Delayed Sleep Phase Syndrome that is the primary cause of insomnia.

 Had an apnea hypopnea index greater than 10 on the first night of Polysomnography Screening.

 Has periodic limb movements during sleep with arousal index greater than 10 as seen on the first night of Polysomnography screening only.

 Has a positive urine drug screen or breathalyzer test.

 Has ever had a history of seizures; sleep apnea, restless leg syndrome, chronic obstructive pulmonary disease, fibromyalgia, or a positive test result for the aforementioned ailments on the screening Polysomnography, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.

 Has a history of psychiatric disorder (including anxiety or depression) within the past 12 months.

 Smokes more than 3 cigarettes per day or uses tobacco products during nightly awakenings.

 Routinely consumes caffeine including coffee, tea and/or other caffeine-containing beverages or food averaging more than 600 mg of caffeine per day.

 Has used any central nervous system drug or other medications, including those used to treat psychiatric disorders, known to affect sleep/wake function within 1 week whichever is longer prior to the administration of single blind study drug.

 Used melatonin, or other drugs/supplements known to affect sleep/wake function within 1 week (or 5 half lives of the drug) whichever is longer prior to the first dose of single blind medication.

 Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:

 Anxiolytics

 Hypnotics

 Antidepressants

 Anticonvulsants

 Sedating H1 antihistamines

 Systemic steroids

 Respiratory stimulants

 Decongestants

 Antipsychotics

 Muscle relaxants

 Over-the-counter and prescription diet aids

 Narcotic analgesics

 Beta Blockers

 St. John's wort

 Kava kava

 Ginkgo biloba

 Modafinil

 Coumadin

 Heparin

 Melatonin and all other drugs or supplements known to affect sleep/wake function will be prohibited within 1 week of the first dose of study medication and during the entire study.

 Has any clinically important abnormal finding as determined by a medical history, physical examination, Electrocardiogram, or clinical laboratory tests as determined by the investigator.

 Has a positive hepatitis panel including anti- Hepatitis A Virus, hepatitis B surface antigen or anti- hepatitis C virus.

 Has any additional condition(s) that in the investigator's opinion would:

 Affect sleep/wake function

 Prohibit the subject from completing the study, or

 Not be in the best interest of the subject.

 Exhibits a placebo response during single-blinded placebo run in period.

 Individuals with a habitual sleep time later than 4:00 am should not be included in the study.

['Ramelteon', 'Ramelteon', 'Ramelteon', 'Placebo']


FLEX-Trial: Prospective Sonographic Assessment Of Healing Process Following Suture of Profound Flexor Tendon Due to Traumatic Rupture of FDP-Tendon in Zone II.

Summary: To prospectively assess the healing process following suture of profound fexor tendon due to traumatic rupture of FDP-Tendon in Zone II by ultrasound.
Inclusion criteria: inclusion criteria:

 All patients with traumatic rupture of FDP-tendon in zone II.

Exclusion criteria: :

 < 18years;

 Fracture;

 crush injury; (partial) amputation;

 RA;

 CPPD;

 CP;


Atrial Fibrillation Ablation The Hybrid Approach Versus Traditional Management

Summary: Rationale: To determine the most beneficial ablation methodology for individual patients with paroxysmal or persistent atrial fibrillation (defined by the Heart Rhythm Society) as surgeons and electrophysiologists work together on a convergent procedure (hybrid) to place the epicardial and endocardial ablation lines.~Objectives: Catheter and surgical ablation are being offered today to patients with drug refractory and symptomatic atrial fibrillation. This study is designed to assess the most efficient ablation approach in patients with paroxysmal and persistent atrial fibrillation. In patients with left atrium size of less than 5.0 cm, a Hybrid approach (pulmonary vein isolation performed surgically will be combined with right and left atrial flutter lines performed using a transcatheter approach) will be compared to percutaneous catheter ablation to isolate the pulmonary veins and apply the left and right atrial flutter lines with removal of LA appendage. In the group of patients with left atrial size 5.0-6.0 cm the Hybrid approach is going to be compared to the minimally invasive Cox-Maze III procedure.~Our hypotheses with regard to the rate of return to sinus rhythm off antiarrhythmic drugs at 6 months will demonstrate that the Hybrid approach is going to be a: superior to percutaneous catheter ablation in the less than 5 cm left atrial group and b: non-inferior when compared to the Cox-Maze III procedure in the 5-6 cm left atrial cm group.~We hypothesize that the safety of all procedures will show no differences and that there will be no differences in clinical complications between groups.
Inclusion criteria: inclusion criteria:

 Patients will be included if they present for ablation with paroxysmal or persistent atrial fibrillation as defined by the Heart Rhythm Society and their left atrium is < 6.1 cm (volume)

 Patients must be symptomatic with their AF as noted by their inability to perform their daily activities due to shortness of breath, fatigue, palpitations or other debilitating symptoms

 Paroxysmal atrial fibrillation is defined as atrial fibrillation that resolves on its own within 7 days of onset

 Persistent atrial fibrillation is defined as atrial fibrillation that does not resolve on its own and requires medical intervention to include medication therapy and/or electric cardioversion

Exclusion criteria: :

 Patients will be excluded if they present with long standing persistent atrial fibrillation as defined by the Heart Rhythm Society

 All patients with MV +2 mitral regurgitation will be excluded

 Require other cardiac surgery procedures will be excluded

 Are unable to take anticoagulation

 Are unable to take any prescribed anti arrhythmic medication

 Have a left atrium measuring greater than 6.0 cm (volume)

 Have had previous catheter ablation for atrial fibrillation

 Have had previous pace maker implantation

 Are less than 18 years of age

 Do not speak English and no translation can be provided

 Are unable or unwilling to be followed according to set protocol to include obtaining an internally heart monitor 6 weeks prior to their ablation procedure

['Pulmonary vein isolation ablation procedure for atrial fibrillation', 'Hybrid procedure for ablation of atrial fibrillation', 'The Cox Maze Procedure for Ablation of Atrial Fibrillation', 'Hybrid Procedure for Left Atrium >5 cm but < 6.1 cm']


Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer

Summary: The primary objective of this study is to compare the progression free survival (PFS) of patients with metastatic castration-resistant prostate cancer treated with enzalutamide in combination with LY2157299 (Arm 1) versus enzalutamide alone (Arm 2).
Inclusion criteria: inclusion criteria:

 Have metastatic castration-resistant prostate cancer

 Must have had prior abiraterone treatment

 Life expectancy of greater than 3 months

 ECOG performance status 0 or 2

 Age ≥18 years

 Have measurable disease

 Patients acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator).

 Ability to take oral medication

 Patients must have adequate organ and marrow function defined by study-specified laboratory tests

 Must use acceptable form of birth control while on study

 Ability to understand and willingness to sign a written informed consent document

Exclusion criteria: :

 Known history or evidence of brain metastases

 Prior chemotherapy for metastatic disease in castration-resistant prostate cancer

 Had surgery within 4 weeks prior to the first dose of study drug

 Had radiation, biological, or other investigational cancer therapy within 2 weeks prior to the first dose of study drug

 Had second-line hormonal therapy within 2 weeks prior to the first dose of study drug

 Systemic steroids within 1 weeks prior to the first dose of study drug

 Had prior enzalutamide, ARN-509, or galeterone therapy

 Have moderate or severe cardiovascular disease

 Have a history of a seizure

 Have uncontrolled intercurrent illness, including but not limited to ongoing or active infection, systematic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric condition that would limit compliance with study requirements

 Have a history of any autoimmune disease:inflammatory bowel disease, (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythmatosus (SLE) autoimmune vasculitis (e.g., Wegener's Granulomatosis), CNS or motor neuropathy considered to be of autoimmune origin (e.g., Guillian-Barre Syndrome, Myasthenia Gravis, Multiple Sclerosis)

 Have known history of infection with HIV, hepatitis B, or hepatitis C


Oral Glycerol and High-Dose Rectal Paracetamol to Improve the Prognosis of Childhood Bacterial Meningitis

Summary: Bacterial meningitis remains a significant cause of morbidity and mortality in children, especially in countries with limited resources. Efforts to improve the grim outcome have included altering the first line antibiotic therapy, controlling seizures and managing fluids more carefully. Adjuvant therapy of steroids has been used with limited success in children in the West and with no proven value in Malawi and other resource constrained settings. Glycerol has been used to reduce brain oedema in neurosurgery and it has recently been shown to reduce morbidity in childhood meningitis in South America. Paracetamol in a high dosage has been shown to reduce inflammation and cytokine levels in septicaemia with improved outcomes in adults.~In Malawi the investigators have tried adjuvant steroids with no improvement in outcome of childhood meningitis. They have recently concluded a study of ceftriaxone which has shown no improvement in mortality though there is less hearing loss than with chloramphenicol and benzyl penicillin.~Following the encouraging results of the Childhood South American Study it is important to assess the use of adjuvant glycerol in children in the investigators' setting. Paracetamol is routinely used in meningitis because of the accompanying fever and headache. This is an opportunity to study its place as adjuvant therapy more carefully than has previously been done.~The investigators propose a prospective, randomized, double blind 2 by 2 factorial designed study to assess the advantage of ceftriaxone (antibiotic) given with paracetamol and glycerol in combination, singly or with neither adjuvant therapy in childhood bacterial meningitis.
Inclusion criteria: inclusion criteria:

 All children aged ≥ 2 months, admitted to Queen Elizabeth Hospital, Blantyre, Malawi, with possible or confirmed acute bacterial meningitis

Exclusion criteria: :

 Age less than two months

 Trauma

 Relevant underlying illness such as intracranial shunt, previous neurological disease (cerebral palsy, Down's syndrome)

 Previous permanent hearing loss (not conductive hearing loss) if known

 Immunosuppression except HIV infection.

['Glycerol and paracetamol', 'Paracetamol', 'Paracetamol', 'Paracetamol', 'Placebo', 'Paracetamol and glycerol', 'Glycerol']

Glycerol and paracetamol
Paracetamol
Paracetamol
Paracetamol
Placebo
Paracetamol and glycerol
Glycerol


Natural History Study of Moles and Suspicious Melanoma

Summary: Background:~Melanocytic nevi, or moles, are non-cancerous growths of a type of skin cell called a melanocyte.~Large congenital melanocytic nevi (LCMN) are a special type of mole that begins to grow before birth and is larger than moles that develop after birth.~Determining how melanocytes in moles and LCMNs differ from normal melanocytes may increase the ability to predict whether a mole will give rise to a melanoma (a type of skin cancer)~Objectives:~To understand how melanomas develop, by studying moles, LCMNs, and pigmented skin lesions that are suspicious for melanoma~To develop better criteria for diagnosing melanoma, particularly by using a device called a digital dermatoscope (a special camera, connected to a computer, that takes pictures of moles when they are magnified and illuminated)~Eligibility:~Children 5 years old or older with an LCMN~Adults 18 years old or older with 100 or more moles larger than 2 mm in diameter and at least one 4 mm or more~Adults 18 years old or older with a pigmented lesion suspicious for melanoma~Design:~Patients' personal and family health history is obtained.~Patients are examined by investigative team doctors, and several lesions are examined with a dermatoscope.~Additional photographs of part or all of the skin surface may be taken.~Some lesions may be biopsied.~Additional tests or examinations may be recommended.~Patients are followed periodically for skin or physical examinations, photography, laboratory and imaging evaluations, and possible skin biopsies.~Children may undergo brain magnetic resonance imaging (MRI)
Inclusion criteria: inclusion criteria:

 Infants/Children

 Must be less than or equal to 5 years.

 Must have large congenital melanocytic nevus (LCMN, diagnosed clinically or by biopsy) that is greater than 20 cm in any one dimension or that is greater than 8 cm in any one dimension involving the scalp.

 Must have outside referring physician.

 OR

 Adults

 Must be greater than 18 years.

 Must have greater than or equal to 100 melanocytic nevi greater than 2 mm in diameter.

 Must have at least one melanocytic nevus greater than or equal to 4 mm in longest dimension.

 Can have prior history of cutaneous or ocular malignant melanoma.

 Must have outside primary physician.

 OR

 Adults

 Must be greater than 18 years.

 Must have a current pigmented lesion clinically suspicious for primary melanoma.

 Must have outside primary physician.

 AND

 All patients, or in the case of infants and children their parents or legal guardians, must be able to understand and sign an informed consent.

Exclusion criteria: :

 The patient does not meet the inclusion criteria.

 Diagnosis of genetic syndrome associated with multiple lentigines or nevi (Peutz-Jeghers syndrome, Carney complex, turner syndrome, Noonan's syndrome).

 Two or more first-degree relatives with history of cutaneous melanoma and familial atypical mole-melanoma syndrome phenotype.

 Diagnosis of cancer-associated syndrome (xeroderma pigmentosum, type I neurofibromatosis, Li-Fraumeni syndrome).

 Inability to tolerate surgical procedure due to bleeding diathesis or disorder or other cause as determined by principal investigator.

 Patient is unwilling to consider elective biopsy of a melanocytic nevus.

['Melanocytic Nevi', 'Acquired Melanocytic Nevi', 'Primary Cutaneous Melanoma']

Melanocytic Nevi
Acquired Melanocytic Nevi
Primary Cutaneous Melanoma


A Pilot Trial Evaluating an Alternating Schedule of Recombinant Human GM-CSF and Azidothymidine in Patients With HIV Infection and Leukopenia

Summary: To evaluate the safety of repeated courses of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) administered subcutaneously to patients with HIV infection and leukopenia. To determine if administration of GM-CSF will prevent some or all of the hematologic toxicity associated with zidovudine ( AZT ) treatment in patients with pre-existing leukopenia. To assess any clinical and/or virologic benefits from administering alternating weeks of GM-CSF and AZT to patients with symptomatic HIV infection who have a history of cytologically confirmed Pneumocystis carinii pneumonia ( PCP ) or a circulating absolute CD4 lymphocyte count less than 200 cells/mm3.
Inclusion criteria: inclusion criteria

 Patients must have:

 Serum antibody to HIV with or without evidence of HIV antigenemia.

 White blood cells (WBC) = or < 4500 cells/mm3 measured on at least 2 occasions separated by a minimum of 1 week.

 Qualifying indications for AZT therapy.

 Life expectancy = or > 6 months.

Exclusion criteria:

 Co-existing Condition:

 Patients with the following conditions or symptoms are excluded:

 Current or past history of malignancy including Kaposi's sarcoma.

 Excessive diarrhea or significant malabsorption.

 If patients have had > 10 percent weight loss within the past 3 months, they should not have malabsorption as evidenced by serum carotene < 75 IU/ml, serum vitamin A < 75 IU/ml, significant malabsorption 4 foul-smelling or greasy stools per day or other criteria.

 Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection (IO).

 Less than 1 week since completing treatment of Pneumocystis carinii pneumonia (PCP).

 Active OI requiring systemic treatment.

 Evidence of nutritional deficiencies that may contribute to anemia and/or leukopenia.

 Concurrent Medication:

 Excluded within 4 weeks of study entry:

 Zidovudine (AZT).

 Other antiviral agent associated with leukopenia.

 Investigational drug.

 Immunomodulators.

 Interferon.

 Steroids.

 Excluded within 8 weeks of study entry:

 Ribavirin.

 Excluded within 4 months of study entry:

 Suramin.

 Patients with the following are excluded:

 Current or past history of malignancy including Kaposi's sarcoma.

 Excessive diarrhea or significant malabsorption.

 Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection (OI).

 Less than 1 week since completing treatment of Pneumocystis carinii pneumonia (PCP).

 Evidence of nutritional deficiencies that may contribute to anemia and/or leukopenia.

 Prior Medication:

 Excluded:

 Prophylactic therapy for Pneumocystis carinii pneumonia (PCP) that may cause leukopenia.

 Risk Behavior:

 Excluded:

 Current drug or alcohol abusers.

 Unprotected sexual contact or other activities that may result in reinfection with HIV.

 Patients must be willing to refrain from unprotected sexual contact or other activities that may result in reinfection with HIV.


Predicting Patients' Response to Spinal Manipulation

Summary: The purpose of this study is to compare the clinical effectiveness of two types of chiropractic spinal manipulation to conservative medical care for patients at least 55 years old with sub-acute or chronic LBP.
Inclusion criteria: inclusion criteria:

 Age 21 to 55

 Idiopathic mechanical low back pain (LBP) matching classification 1-4 of the Quebec Task Force.

 LBP classified as subacute (onset 4-12 weeks previous) or chronic (onset more than 12 weeks previous), with the current episode occurring at least four weeks prior to the date of contact with the clinic: In order to exclude the greatest proportion of LBP patients that have a favorable natural history of improvement.

 Written Informed Consent

 A minimum baseline score on the Roland Morris Disability Questionnaire (RMQ) of 6 points.

Exclusion criteria: :

 LBP from other somatic tissues as determined by history, examination, and course (e.g. pain referred from visceral conditions).

 LBP diagnosis not meeting Classifications 1 through 4 of the Quebec Task Force, especially the following: low back pain associated with frank radiculopathy defined as typical shooting leg pain; positive straight leg-raising test; an altered lower extremity reflex; a dermatomal sensory deficit; at least one of the following: progressive unilateral muscle weakness or motor loss, or symptoms of cauda equina compression; and CT or MRI evidence of related anatomical pathology (e.g. abnormal disc, stenosis).

 Co-morbid pathology or poor health conditions in patients; Co-morbid conditions and general poor health significantly complicate the prognosis of LBP, and inject a variety of uncontrollable factors in case-management, not to mention experimental analysis and interpretation. Patients who have case histories and physical examination findings indicating other that average good health will be excluded from the study.

 Bone and joint pathology contraindicating patient for SM of the lumbar spine and pelvis: Patients with spinal fractures, tumors, infections, arthropathies, and significant osteoporosis will be referred to appropriate health care.

 Other contraindications for SM of the lumbar spine and pelvis (e.g. bleeding disorders or anticoagulant therapy, extreme obesity).

 Retention of legal advice related to this or a previous LBP episode: Patients with occupational or personal injuries will not be automatically excluded from the study unless they answer yes to a specific question about the retention of legal advice with respect to their LBP episode at the baseline interview.

 Pregnancy: Pregnancy is a contraindication for exposing a patient to ionizing radiation and is a confounding factor in the usual course of LBP.

 Inability to read or verbally comprehend English.

 Clear evidence of narcotic or other drug abuse as determined by history and examination: injects significant confounding factors with respect to internal validity and feasibility.

 Major clinical depression: Patients with scores greater than 17 on the Beck Depression Inventory will be excluded from the study. Patients with evidence of other psychiatric disorders as determined by history and exam will also be excluded.

 Use of manipulative care for any reason within the past 3 months as determined by history: to exclude the possibility of carryover effects.

 Unwillingness to postpone use of all other types of manual treatment for LBP except those provided in the study (including chiropractic and osteopathic SM, physical therapy, and massage) for the duration of the study period: to eliminate confounding effects.

['HVLA-SM', 'LVVA-SM', 'Usual Medical Care']


The Effects of Conversion From Cyclosporine to Tacrolimus on the Changes of Cardiovascular Risk Profiles and Serum Metabolites in Renal Transplant Recipients

Summary: The purpose of this study is to evaluate the effects of conversion from cyclosporine to tacrolimus on the changes of cardiovascular risk profiles and serum metabolites in renal transplant recipients.
Inclusion criteria: inclusion criteria:

 Patients who received a kidney transplant at least 12 months ago prior to enrollment

 Patients who have kept in unchanged cyclosporine therapy at least for 6 months prior to enrollment.

 Female patients of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment, and agreed to the deliberate prevention of conception during the trial

 Patients who are considered clinically stable by observer's judgment.

 Patients must understand the purpose and risk of participating the the trial and signed on the written consent.

Exclusion criteria: :

 Patients who have previously received an organ transplant other than a kidney

 Patients diagnosed with congestive heart failure within 6 months (EF <35%)

 Patients with untreated ischemic heart disease

 Patients whose hemoglobin is in the level of <7.0 g/dL

 Patients who have a known hypersensitivity to tacrolimus

 Patients taking potassium sparing diuretics

 Patients newly diagnosed malignant tumors after organ transplant but the patients treated completely with basal or squamous cell carcinoma of the skin are excepted

 Patients who are at the risk of drug abuse or mental disorders or communicate difficulties with the observer

 Patients who are pregnant or lactating


To Compare the Efficacy of I.V 200 mg Iron Sucrose and 500 mg Iron Sucrose to Treat Anemia in Pregnancy

Summary: This study is aimed to compare the efficacy of 2 doses of iron sucrose given intravenously - 200 mg versus 500 mg.
Inclusion criteria: inclusion criteria:

 Singleton pregnancy

 Iron deficiency anemia

 Intolerance or low compliance for oral iron

Exclusion criteria: :

 Known allergy for iron supplements

 Anemia not due to iron deficiency

 Acute infection

 Liver failure or viral hepatitis

 Thalassemia or hemoglobinopathies

 Asthma

 Multiple pregnancy

['Iron sucrose 200 mg', 'Iron sucrose 500 mg']


Positron Emission Tomography Assessment of the Central Nervous System Effects of Eszopiclone and Zolpidem

Summary: This study will compare the interactions of a placebo and two FDA-approved sleeping medications, Eszopiclone (Lunesta) and Zolpidem (Ambien), with certain chemical receptors in the brain. We want to show that we can use positron emission tomography images to measure the binding of these medications to the receptors.
Inclusion criteria: inclusion criteria:

 Healthy Males age 18 to 35 inclusive

 Body Mass Index 18 to 30

 Willing to adhere to prohibitions and restrictions specified in protocol

 Must give informed consent.

Exclusion criteria: :

 Clinically significant abnormal lab values for chemistry, hematology or urinalysis at screening.

 Clinically significant abnormal physical exam, vital signs, or 12-lead EKG at screening

 Significant history of or current significant medical illness.

 Significant history of or current psychiatric or neurological illness or sleep apnea.

 Participation in another research study involving exposure to ionizing radiation within the last 12 months.

 Any clinically significant MR abnormality which may be relevant to the study.

 Metal implants which are relevant for MR or PET procedures or data.

 History of epilepsy or fits or unexplained blackouts.

 Serology positive for Hepatitis B surface antigen, Hepatitis C antibodies, or HIV antibodies.

 Positive urine screen for drugs of abuse.

 Positive alcohol screen.

 Known or suspected alcoholism or drug addiction even if currently abstaining

 Drinks on average more than 8 cups of coffee, tea, cocoa, or cola per day.

 Smoking cigarettes within 3 months prior to study drug administration.

 Clinically significant acute illnes within 7 days of study drug administration.

 Claustrophobia.

 Donation of 1 or more units of blood (approximately 450ml), or acute loss of an equivalent amount of blood within 90 days prior to study drug administration.

 Have received an experimental drug or used an experimental medical device within 90 days of planned start of treatment with drugs for this study.

 Use of any prescription or over the counter medication, or herbal medication (not including non-steroidal anti-inflammatory drugs) within 2 weeks of the first PET scan. Of particular concern would be GABA-ergic compounds and CYP3A4 inhibitors. Exclusion should also be considered if the subject has taken a drug with a long half-life (or of any metabolite) even if taken outside the two week time window. However, the subject can still be enrolled if, in the opinion of the investigator, such medication taken in that timeframe will not interfere with the results of the study.

 Psychological or emotional problems that would render the informed consent invalid or limit the ability of the subject to comply with the study requirements.

 Any condition that in the opinion of the investigator would complicate or compromise the study, or the well-being of the subject.


Trans Nasal Insufflation for the Treatment of Snoring

Summary: This research is being done to examine if a nasal cannula can be used to keep the throat open during sleep, thereby treating sleep apnea.~People with sleep apnea and people who snore without sleep apnea may take part in this study. Sleep apnea is a disorder caused by pauses in breathing due to repetitive closure of the throat. The most common form of treatment for sleep apnea is continuous positive airway pressure (CPAP) therapy. While CPAP therapy remains the simplest and most effective treatment for snoring and sleep apnea, patients have to wear a nasal mask throughout the night. For this reason, patients often have difficulty sticking to therapy.~Participants enrolled in this study will spend 3-nights in a sleep laboratory. In all nights, the investigators will monitor your sleep and your breathing throughout the night. The investigators will apply several electrodes (sensors) to your scalp and face to monitor your sleep and breathing, and other sensors to your chest, abdomen, cheek, and a finger to monitor your breathing and oxygen level.
Inclusion criteria: inclusion criteria:

 Consenting adults over the age of 21

 Diagnosed obstructive sleep apnea

Exclusion criteria: :

 Unstable cardiovascular disease

 Uncontrolled hypertension (BP > 190/110)

 Severe intrinsic lung diseases (supplemental O2 > 2 L/min during the day)

 History of chronic renal insufficiency

 History of hepatic insufficiency

 Pregnancy

 Bleeding disorders or Coumadin use

 Sleep Disorders other than Obstructive Sleep Apnea (OSA)

 Tracheostomy

 Allergy to lidocaine

['Trans Nasal Insufflation (TNI) [nasal canula]']


Prospective Randomized Study of the Impact on the Autonomy of the Elderly of 75 Years of Age and Older by the UPSAV

Summary: Background :~The evolving concept of frailty was born in the United States under the term of  frail elderly . It allows describing geriatrics situations, dominated by the weakness or the functional instability of aged person, illustrating situations at risk. It is about an effective concept, especially in the field of the prevention where it determines strategies of specific care. The ageing, changing according to individuals, is characterized by a decrease of the physiological reserves leading to a precarious balance and to a destabilization.~Epidemiological studies show a very uneven distribution of three categories of old persons according to their health status. Every year, approximately, 12 % of the independent population of 75 years of age and older and living at home, lose their autonomy for one of the activities of the daily life and turn into frailty.~Identifying frailty of old subjects is interesting in order to apply preventive and specific care strategies to reduce the risks of decompensation. The Global Geriatric Assessment (GGA) is the gold standard to detect frailty in this population. The beneficial effects of the GGA during the hospitalization have been recognized in international literature.~The ageing heterogeneousness complexity and the high time-consuming character of GGA led to a difficult approach for the nurses or family practioners in taking care of old persons at home.~To balance these difficulties and to optimize prevention of dependence in the elderly, an experimental unit of prevention was created : Unit for Prevention, Monitoring and Analysis of Aging (UPSAV) on January 4th, 2010 within the geriatric department of the Hospital University of Limoges. It is an innovative organizational structure because, for the first time, the geriatric expertise is proposed freely to the elderly at home. A multidisciplinary gerontological team consisting in a geriatrician, a nurse, a psychomotor therapist and an occupational therapist, can, on requiry, move at old persons' home to make a preventive GGA to detect the risks of loss of autonomy and to propose a coordination of preventive actions.~Purpose :~UPSAV's endpoints are to prevent frail elderly persons from the risk of autonomy loss. This action is led in partnership with all the professionals working around old persons.~The randomized study endpoint is to evaluate elderly from 75 years of age and older at home and to select two homogeneous groups: reference and  specific intervention .
Inclusion criteria: inclusion criteria:

 75 years of age and older man or woman

 Patient covered by the health care system

 Patient coverd by a complementary health system or supported by 100% by the health care system

 Patient having the intellectual skills to understand the study, to respect its imperatives and accept the UPSAV's plan or subject with mild to moderate dementia (MMSE > 10) but with a caregiver at home capable of understanding the protocol and of making respect its imperatives written consent signed by the patient

Exclusion criteria: :

 Nursing-home resident

 Mild to moderate dementia (MMSE > 10) without caregiver

 Severe dementia (MMSE < 10)

 Diseases with vital short-term endpoint

['the Elderly of 75 Years and Older Living at Home']


Sex Differences in Coronary Pathophysiology

Summary: This is a research study evaluating possible causes of chest pain (or an anginal equivalent, such as fatigue resulting in a decrease in exercise tolerance, shortness of breath, or back, shoulder, neck, or jaw pain) in people with no evidence of significant coronary artery disease on their coronary angiogram (pictures of the blood vessels in the heart). The purpose of the research study is to determine if there is diffuse atherosclerosis (plaque) not appreciated by angiography, or if the coronary endothelium (lining of the blood vessels in the heart) and/or microcirculation (small vessels in the heart that are not easily seen with an angiogram) are not functioning properly in those who have chest pain (or an anginal equivalent), but normal coronary arteries on angiography. Specifically, we are interested if these findings are more common in women than men.
Inclusion criteria: inclusion criteria:

 Patient referred for elective coronary angiography because of a reasonable clinical suspicion of coronary ischemia.

 Presence of angina or an anginal equivalent (including chest, back, shoulder, arm, neck, jaw discomfort, or shortness of breath brought on by physical exertion, emotional stress, or certain times of day/month).

Exclusion criteria: :1) Asymptomatic (such as a pre-op cath)

 2) Status-post heart transplant

 3) Status-post coronary artery bypass grafting

 4) Age <18

 5) Renal insufficiency (creatinine >1.5)

 6) Presence of an acute coronary syndrome (STEMI or NSTEMI), Tako-tsubo, an abnormal ejection fraction (EF<55%), cardiogenic shock, or recent VT/VF

 7) Presence of another likely explanation of chest pain, such as pulmonary hypertension or aortic stenosis

 8) History of adverse reaction to any of the medications being used (acetylcholine, nitroglycerin, adenosine, or heparin)

 9) Currently taking vasoactive medication (such as nitroglycerin)

 10) Inability to provide an informed consent, including an inability to speak, read, or understand English, Spanish, Chinese, Farsi, Japanese, Korean, Russian, or Vietnamese

 11) A hearing impairment that won't allow for a typical verbal conversation or a visual impairment that won't allow for reading of the written consent

 12) Participation in another study (with the exception of the Stanford Gene-PAD study)

 13) A potentially vulnerable subject (including minors, pregnant women, economically and educationally disadvantaged, decisionally impaired, and homeless people)

['30 cc blood draw', 'Intravascular ultrasound (IVUS)', 'Coronary pressure/flow wire testing', 'Coronary pressure/flow testing: Acetycholine challenge', 'Procedure: Coronary pressure/flow testing: Nitroglycerin challenge', 'Procedure: Procedure: Coronary pressure/flow testing: Adenosine challenge']


Resistance Exercise and Knee Osteoarthritis Pain, Functional Impairment and Cartilage Turnover

Summary: The purpose of this study is to determine if a 4 month resistance exercise program can reduce knee osteoarthritis pain functional impairment and cartilage turnover.
Inclusion criteria: inclusion criteria:

 Osteoarthritis (OA) of the knee for >6 months

 moderate to severe pain immediately following a 50-foot walk

 knee pain primarily due to tibiofemoral OA and not from patellofemoral OA

 bilateral standing anterior-posterior radiograph demonstrating grade 2 or 3 OA of the target knee

 willing and able to participate in regular exercise for four months

 free from musculoskeletal limitations that would preclude resistance exercise participation

 free of abnormal cardiovascular responses during the screening graded maximal walk test

Exclusion criteria: :

 unable to walk

 regular resistance exercise training (>3X week) within the past 6 months

 specific low back pain or acute back injury

 spinal stenosis that precludes walking one block due to neurogenic claudication

 any major injury to either knee within the prior 12 months

 any surgery to either knee within the last 12 months

 lumbar radiculopathy

 vascular claudication

 significant anterior knee pain due to diagnosed isolated patella-femoral syndrome or chondromalacia in either knee

 have had corticosteroid or viscosupplement injections within three months of study participation

 have added new over the counter or prescription pain medication within two months of study participation

['normal activities and clinical care', 'Concentric Focused Resistance Exercise', 'Eccentric Focused Resistance Exercise']

normal activities and clinical care
Concentric Focused Resistance Exercise
Eccentric Focused Resistance Exercise


Safety and Effectiveness of Rilonacept for Treating Systemic Juvenile Idiopathic Arthritis in Children and Young Adults

Summary: Systemic juvenile idiopathic arthritis (SJIA) is a type of arthritis that typically occurs before 16 years of age. SJIA usually involves heat, pain, swelling, and stiffness in the body's joints. It can also involve fever, rash, anemia, and inflammation in various parts of the body. Rilonacept is a drug that can reduce inflammation. The purpose of this study is to determine whether a rilonacept drug regimen initiated early is more effective than a similar rilonacept drug regimen initiated 4 weeks later when treating children and young adults with SJIA.
Inclusion criteria: inclusion criteria:

 Fulfills International League Against Rheumatism (ILAR) criteria for SJIA

 Duration of SJIA lasting at least 6 weeks since onset

 Active disease as defined by at least two joints with active disease

 Not currently receiving methotrexate OR if taking methotrexate, the dose has remained stable or has been discontinued for 4 weeks prior to screening

 Has never received certain biologics OR if previously received biologics, discontinued etanercept for at least 4 weeks prior to screening and discontinued infliximab or adalimumab for at least 8 weeks prior to screening

 Not currently receiving corticosteroids OR if taking oral corticosteroids, the dose has remained stable between 2 and 60 mg/day for at least 2 weeks prior to screening

Exclusion criteria: :

 Past treatment with anakinra, rilonacept, or other biologic IL-1 inhibitor

 Treatment with other disease-modifying antirheumatic drugs (DMARDs) including, but not limited to, azathioprine, sulfasalazine, cyclosporine, and thalidomide within 4 weeks of screening

 Treatment with leflunomide without cholestyramine washout at the end of therapy

 Treatment with cyclophosphamide within 3 months of study entry

 Treatment with tacrolimus or tocilizumab within 4 weeks of study entry

 Treatment with rituximab within 6 months of study entry

 Treatment with intravenous immunoglobulin (IVIG) within 4 weeks of screening

 Kidney disease

 AST or ALT levels more than two times the upper limit of normal

 Bilirubin levels higher than 1.5 mg/dl

 Thrombocytopenia, leukopenia, or neutropenia

 Abnormal prothrombin time (PT) and partial thromboplastin time (PTT) tests

 Low levels of plasma fibrinogen

 Evidence of chronic recurrent infection or other significant, non-SJIA illness that might interfere with study participation

 Psychological or cognitive difficulties that might interfere with study participation

 Current drug or alcohol abuse

 Anticipated poor compliance to assigned study regimen

 Participation in another clinical trial within 30 days of study entry

 Major surgical procedure within 3 months of study entry


Trial of a Cardiac Rehabilitation Program Delivered Remotely Through the Internet

Summary: Cardiac rehabilitation programs (CRP) are a proven treatment for those with ischemic heart disease (IHD). These programs have been demonstrated to improve adherence to regular physical activity, a healthy diet and smoking cessation, as well as modify risk factors for IHD such as hypercholesterolemia, hypertension, obesity and type 2 diabetes. In addition, CRP are cost effective and can result in a 25% reduction in reoccurrence of mortality. Despite the known benefits of CRP, as little as 10% to 25% of eligible patients attend these programs. One of the main barriers to attendance is proximity to a CRP, as the majority of these programs are limited to hospitals in large urban areas. However, cardiovascular diseases do not discriminate by geography, resulting in a geographic inequity of care for patients living in rural, remote and smaller urban/sub-urban centres. Currently there are no CRP specifically designed for patients in rural and remote areas. The use of the Internet may present itself as a viable alternative. We have recently completed a pilot study of a virtual CRP (vCRP) that demonstrated significant improvements in exercise capacity and risk factors. This investigation will study the vCRP in a group of IHD patients who do not have access to hospital-based CRP.~Hypotheses A. Participation in a 4 month Internet-based cardiac rehabilitation program will result in significant improvements in exercise capacity compared to usual care, in patients with diagnosed IHD.~B. Participation in a 4 month Internet-based cardiac rehabilitation program will result in significant improvements in exercise capacity after one year compared to usual care, in patients with diagnosed IHD.~Study Population Men and women over 18 years will be identified from consecutive in-patients of the British Columbia Provincial Heart Centre at St. Paul's Hospital in Vancouver who reside in either the Northern Interior or Coast Garibaldi health areas. Patients will be eligible if they have IHD, Internet access, no previous experience with cardiac rehabilitation and no physical limitations to exercise. A total of 74 patients (37 per group) will be recruited and randomized to either usual care, or a 4 month 'virtual' cardiac rehabilitation program delivered via the Internet.~Usual Care Group Patients randomized to usual care will be provided with simple guidelines for safe exercising and healthy eating habits, and return to the care of their primary care physician. Patients will return at 4 and 16 months later for outcome assessment. There will be no contact between the study personnel and usual care patients for the duration of the study, nor will there be any attempt to control the level of patient care.~Intervention The vCRP has been developed to mimic hospital-based CRP and includes online intake forms, one-on-one chat sessions with vCRP nurse, dietitian and exercise specialist, data collection (exercise heart rate, blood pressure, glucose- if diabetic), peer-support group chat sessions, ask-an-expert chat sessions, education, progress reports and online resources. Upon randomization to the intervention, patients will receive access to the website, a heart rate monitor and a blood pressure monitor and trained in their use. The heart rate monitors allow for exercise heart rate data to be stored and downloaded to their home computer and then uploaded to the vCRP webserver. The exercise data will be reviewed weekly. A letter to the patient's primary care physician will be sent to outline the vCRP intervention, the treatment algorithms to be used and indicate under what circumstances the vCRP nurse and/or patient may contact them with regards to their management. Patients will receive one-on-one counselling by the nurse, dietitian and exercise specialist via chat sessions at 3 to 4 week intervals. After the 4 month intervention, patients will be discharged into the care of their primary care physician.~Outcomes Participants will be assessed at baseline, 4 and 16 months for risk factors and lifestyle behaviours. The primary outcomes will be the change in exercise capacity as between the two groups from baseline to 4 months, and from baseline to 16 months. Exercise capacity will be assessed as total time on a symptom-limited exercise stress test.
Inclusion criteria: inclusion criteria:

 Men and women admitted for an IHD event (acute coronary syndrome or revascularization procedure) who are at low or moderate risk.91

 Regular Internet access (home, work or other environment).

 Over 18 years of age.

 Permission of the attending physician.

 Able to read, write and understand English without difficulty.

 No physical limitations to regular activity.

Exclusion criteria: :

 Previous experience with a cardiac rehabilitation program.

 Patients with depression, uncontrolled diabetes and other significant co-morbidities that may interfere with effective IHD management.

 Those patients, who in the mind of the attending physician, are unsuitable for participation.

 Those unable to provide informed consent.

 Pregnant women.

 High-risk patients for safety considerations (future studies will include high-risk patients).


Selenium Treatment in Autoimmune Thyroiditis (AIT)

Summary: Selenium suppresses autoimmune destruction of thyrocytes and decreases titers of serum TPOAb in AIT patients. Older 4 clinical trials approved the efficacy of the daily dose of 200micg. It's believed that Se saturates the deficient stores of GPX so GPX saves the thyrocytes against to oxidative stresses. Although less than 70 micg/d is sufficient to maximize GPX activity, none of the authors tested the doses less than 200 micg/d. Our hypothesis was that If 100 micg/d can not suppress the TPOAb titers,it means autoimmune destruction can not be blocked by saturation of deficient stores of GPX solely and the mechanism of action requires more than repletion of deficient stores. It's important not only to estimate the optimal dose but to understand the mechanism of action. High dose therapy may also suppress TPOAb levels in Se-non-deficient AIT patients, if it is so, Se therapy may becomes the solely treatment modality which can suppress the autoimmunity in more than 400 million AIT patients. Because there've been no way to suppress autoimmune war and replacement of LT4 had been the only treatment modality for palliation. An other independent part of the study is to test the effect of Se in adolescent AIT patients.
Inclusion criteria: inclusion criteria:

 Clinically approved AIT patients who do not use any medication other than LT4 to keep TSH in the lower half of normal range.

Exclusion criteria: :

 Any kind of drug use other than LT4 or any kind of known pathology which may effect GIS absorption.

['Autoimmune Thyroiditis', 'Hashimotos Thyroiditis']

Autoimmune Thyroiditis
Hashimotos Thyroiditis


Identification and Therapy Efficacy of Type 2 Diabetes in Hispanic Patients

Summary: The two major types of diabetes are type 1 and type 2 diabetes. Although most patients with type 2 diabetes are older than age 40, type 2 diabetes has been reported with increasing frequency among patients under the age of 20. This form of diabetes has been called type 2 diabetes of youth, abbreviated type 2Y. Little is known about the etiology of type 2Y; however, clinicians believe that it occurs most commonly in obese children of particular ethnic groups. A positive family history appears to be one major risk factor for developing type 2Y diabetes. The individual contribution of ethnicity, obesity, and genetics to type 2Y have yet to be elucidated. There is no consensus regarding treatment with type 2Y diabetes. Observation of our Hispanic patients in the Houston area reveals a large number with type 2Y. The major purpose of this study is to examine the genetic and environmental risk factors such as family history, ethnicity, and obesity in Hispanic children with type 2Y diabetes. SPECIFIC AIMS: 1) To examine the genetic and environmental risk factors and clinical signs associated with type 1 diabetes and type 2 diabetes of youth. 2) To compare the efficacy of the treatment modalities, insulin and oral agents, in type 2Y patients. METHODS: We will undertake a retrospective case study, to include a review of hypothesized risk factors in all the medical records of pediatric diabetes patients seen at University of Texas. We anticipate that approximately 200 patients with type 1 diabetes and 30 patients with type 2Y diabetes will be identified. A Sustacal challenge test will be done in patients with a suspected diagnosis of type 2Y in order to confirm the clinical diagnosis. Parents will be contacted by phone for a detailed pedigree intake. Type 1 and type 2Y patients will be compared for each of the studied features. A retrospective review of diabetes type 2 therapies used in type 2Y patients will be undertaken through further examination of the medical records in order to compare insulin treatment to oral agents. We will also test a subset of the patients for the gene identified in adult Hispanics with type 2 diabetes.
Inclusion criteria: inclusion criteria:

 Approximately 30 pediatric patients (ages 10-18) believed to have a diagnosis of type 2Y. Each subject must have been diagnosed for at least one year.

Exclusion criteria: :

 Patients over the age of 18 or under the age of 10

 Patients in whom intellectual functioning is impaired sufficiently to interfere with the understanding of the protocol.


Diagnostic Algorithm in Patients With Minor Head Injury

Summary: The objective of this prospective study is to evaluate the reliability of plain x-rays vs.cranial computed tomography as a screening method for skull fractures and its prognostic value for intracranial bleeding (ICB).
Inclusion criteria: inclusion criteria:

 head injury, nausea, vomiting

Exclusion criteria: :

 no head injury

['Minor Head Injury', 'Traumatic Brain Injury']

Minor Head Injury
Traumatic Brain Injury


Providing Adolescent Contraception in the Emergency Room

Summary: The purpose of this pilot study is to determine the feasibility of comprehensive contraceptive counseling intervention in a pediatric emergency department and to determine the impact of comprehensive contraception counseling on initiation of contraception among sexually active adolescents presenting to a pediatric emergency department.
Inclusion criteria: inclusion criteria:

 Ages 13 to 18 years old

 Speaks English or Spanish

 Has menstrual periods

 Has Medicaid insurance

Exclusion criteria: :

 Seeking contraception as their primary complaint

 Currently pregnant based on urine or serum pregnancy testing

 Has an IUD or contraceptive implant (Implanon/Nexplanon)

 Critically ill, hemodynamically unstable, altered mental status, developmentally delayed, severe pain or distress, or have major trauma

 In juvenile justice custody


Laparoscopic Surgical Management of Endometriosis on Fertility

Summary: The aim of the investigators study is to know the results of the endometriosis surgery and particularly to highlight a benefit of this surgery on fertility.
Inclusion criteria: inclusion criteria:

 Patients over 18 years

 Patients operated by laparoscopy for endometriosis in our department between 2006 and 2014.

Exclusion criteria: :

 Patients under 18 years


Impact of a Multifaceted Program to Prevent Postoperative Delirium in the Elderly

Summary: Postoperative delirium is common in the elderly and is associated with a significant increase in mortality, complications, length of hospital stay and admission in long care facility. Several interventions have proved their effectiveness to prevent it but their combination within a multifaceted intervention needs to be assessed using rigorous methodology based on randomized study design. CONFUCIUS trial aims to measure the impact of a multifaceted program on the prevention of postoperative delirium in elderly.
Inclusion criteria: inclusion criteria:

 Male or female subject aged over 75 years

 Admission for a scheduled surgery (i.e. all oncologic digestive surgery , ureterostomy, nephrectomy or cystectomy, total hip or knee replacement)

 Participation agreement

Exclusion criteria: :

 Patients with a progressive and/or poorly managed psychiatric pathology (patients with stabilized depression could be included in the study)

['Multifaceted prevention program HELP(Hospital Elder Life Program)']


Quality of Life(QoL) in Korean Postmenopausal Osteoporosis Patients With Bisphosphonate Treatment

Summary: Quality of Life (QoL) in Korean postmenopausal osteoporosis patients with bisphosphonate treatment
Inclusion criteria: inclusion criteria:

 Who have been diagnosed with postmenopausal osteoporosis by physician Who have received any oral bisphosphonates (weekly or monthly) at least for 2 months to provide answer of OPSAT-QTM questionnaire Who provide informed consent for study participation

Exclusion criteria: :

 Do not understand the contents of the questionnaire


Left Rule, D-Dimer Measurement and Complete Ultrasonography to Rule Out Deep Vein Thrombosis During Pregnancy.

Summary: In pregnant women with suspected DVT, a sure diagnosis is mandatory. In non-pregnant patients, sequential diagnostic strategies based on 1) the assessment of clinical probability, 2) D-dimer measurement and 3) compression ultrasonography (CUS) have been well validated.~Clinical probability assessment by clinical prediction rules (CPRs) is a crucial step in the management of suspected DVT. However, the most commonly used CPR for DVT, the Wells' score, has never been validated in pregnant women. Recently, the 'LEFt' clinical prediction rule was derived and internally validated. A prospective validation of this rule is now warranted, and we plan to use it in our prospective study.~The second step used in the diagnostic strategy including non-pregnant patients is D-dimer measurement. The test has been widely validated in non-pregnant patients and, in association with a non-high clinical probability, it allows to safely rule out DVT.~As D-dimer level raise steadily during pregnancy, the specificity of the test decreases and it is less useful in pregnant women. Data from the literature clearly suggest that the usual cut-off set a 500 ng/ml would safely rule out DVT in pregnant women [6]. As the usual cut-off has never been prospectively validated in pregnant women with suspected DVT, we would like to use it in our study.~Some studies suggested that complete CUS is safe to rule out DVT in pregnant women. However, this test is not always available. Therefore, a strategy in which the association of clinical probability assessment and D-dimer measurement would allow to safely rule out DVT in a significant proportion of patients without performing a complete CUS, would be of great help in everyday clinical practice and would probably be cost-effective.~Therefore, we plan a prospective study to assess the safety of a sequential diagnostic strategy based on the assessment of clinical probability with the LEFt rule, D-dimer measurement and complete CUS in pregnant women with suspected DVT.
Inclusion criteria: inclusion criteria:

 Pregnant women with clinically suspected DVT

Exclusion criteria: :

 Age less than 18

 No available informed consent

 Associated suspicion of pulmonary embolism

 Ongoing anticoagulant treatment

 Planned anticoagulant treatment at therapeutic dosage during pregnancy

['Left rule, D-dimer measurement and complete ultrasonography in pregnant women.']


Somatic Stem Cells in Endometriosis

Summary: Human endometrium is a very dynamic tissue characterized by cyclical process of proliferation, differentiation and cellular shedding as part of each menstrual cycle. This issue suggests the presence of somatic stem cells. Endometriosis is characterized by presence of endometrium outside the uterine cavity. The existence of a somatic stem cell population in endometrium could explain the incorrect proliferation of these cells, which would lead to formation of endometriotic foci.
Inclusion criteria: inclusion criteria:

 inclusion criteria for patients with endometriosis:

 Female patients with ovarian endometriosis, peritoneal and recto-vaginal.

 Aged between 20 and 40.

 Signing of informed consent for collection and storage of biological samples.

Exclusion criteria: :

 Contraindications for endometrial biopsy.

 Failure to sign informed consent for collection and storage of biological samples.


Oropharyngeal Space in Videolaryngoscopy

Summary: In this randomised crossover trial we measure the space between the right side of the laryngoscope blade and the right palatopharyngeal wall in a cohort of ASA I-III patients with a normal mouth opening. We compare the remaining spaces for seven different videolaryngoscopes and compare these to a classic Macintosh laryngoscope.
Inclusion criteria: inclusion criteria:

 Informed patient consent

 ASA I - III

 Age > 18 years

 Elective surgery, other than head and/or neck surgery

 Pre-operative Mallampati I - III

 BMI < 35 kg/m2

 Fasted (≥6 hours)

Exclusion criteria: :

 No informed patient consent

 ASA ≥ IV

 Age < 18 year

 Emergency surgery, surgery of head and/of neck

 Locoregional anaesthesia

 Pre-operative Mallampati IV

 BMI > 35 kg/m2

 Fasted < 6 hours

 Pre-operative expected difficult airway (restrict neck movement, thyromental distance < 65mm, retrognathia)

 Bad, fragile dentition

 Dental crowns and/or fixed partial denture

['C-MAC ® videolaryngoscope', 'Coopdech® videolaryngoscope', 'McGrath® Series 5 videolaryngoscope', 'Glidescope® Cobalt videolaryngoscope', 'King Vision® videolaryngoscope', 'Venner® videolaryngoscope', 'McGrath® MAC']

C-MAC ® videolaryngoscope
Coopdech® videolaryngoscope
McGrath® Series 5 videolaryngoscope
Glidescope® Cobalt videolaryngoscope
King Vision® videolaryngoscope
Venner® videolaryngoscope
McGrath® MAC

['Abrasion of Soft Palate', 'Intubation Complication']

Abrasion of Soft Palate
Intubation Complication


Vascular Endothelial Growth Factor Levels in Ectopic Pregnancy

Summary: The aim of this study is to determine plasma Vascular Endothelial Growth Factor level and change in patient with ectopic pregnancy who needs to surgical treatment.~Patient with ectopic pregnancy diagnosed and treated with medically or surgically will be included in the study. This is an observational study.The plasma Vascular Endothelial Growth Factor level will be measured first day and two day after the diagnosis of ectopic pregnancy.
Inclusion criteria: inclusion criteria:

 Patients who suspected ectopic pregnancy

Exclusion criteria: :

 hemodynamically unstable patient

 healthy pregnancy (a healthy increase in ß HCG)

 missed abortion

 incomplete abortion

 The patient who need immediate surgical treatment

['Complication Following Ectopic Pregnancy']


Thyroxine Titration Study

Summary: The aim of the study is to examine the effects of fine titration of thyroxine dosage on symptoms of hypothyroidism, wellbeing and quality of life. The hypothesis is that symptoms of hypothyroidism, wellbeing and quality of life will be improved in thyroxine-treated subjects when serum thyrotropin (TSH) is suppressed and/or in the lower reference range, compared to when TSH is in the upper reference range.
Inclusion criteria: inclusion criteria:

 Male or female subjects >18 years of age

 Primary hypothyroidism ≥6 months duration arising from autoimmune hypothyroidism, thyroidectomy or radioiodine treatment

 Thyroxine dose ≥100 mcg/day

 No change in thyroxine dose in past 2 months

 Serum TSH of 0.1-4.8 mU/L

 Adequate contraceptive measures for women of childbearing age

Exclusion criteria: :

 Major systemic illness affecting quality of life or likely to affect participation in the study

 Treatment with T3 currently or in past 2 months

 History of thyroid cancer requiring suppression of TSH secretion by thyroxine

 Ischaemic heart disease - previous myocardial infarction, angina or coronary artery revascularisation

 Renal failure: serum creatinine >135 micromol/L

 Known liver disease with alkaline phosphatase or ALT >2x upper limit of reference range

 Bony fracture in past 3 months or Paget's disease of bone

 Secondary (central) hypothyroidism or hypopituitarism


Power Spectral Analysis of Breath Sound in Pulmonary Edema

Summary: Pulmonary edema can be classified into cardiogenic pulmonary edema and non-cardiogenic pulmonary edema according to the underlying etiology. Cardiogenic pulmonary edema is caused by the dysfunction in the cardiac pumping capability, leading to the transudation accumulation in the pulmonary peri-capillary space. The predisposing factors of non-cardiogenic pulmonary edema are numerous, including severe infection, renal failure, auto-immun reaction, etc. The mortality rate of pulmonary edema is relatively high, especially the non-cardiogenic one. To distinguish the type of pulmonary edema at the early stage is important for its treatment.~Lung sound analysis via stethoscope is a simple diagnostic method to lung diseases clinically. Among many kinds of lung sounds, the crackle and rale are frequently found in pulmonary edema. Rale is also called moist rale. It is considered as low-frequency wheezes and is often seen in cardiogenic pulmonary edema. On the other hand, crackle is also called dry rale, which is a kind of high-frequency wheezes and usually seen in Acute Respiratory Distress Syndrome (ARDS) that is classified into non-cardiogenic pulmonary edema.~This proposed project intends to establish a digital diagnostic method for pulmonary edema. The lung sound of patient with pulmonary edema will be collected by the lung sound acquisition system. By identifying the significant spectrum characteristics of cardiogenic pulmonary edema and non-cardiogenic pulmonary edema, the diagnostic system might be established.
Inclusion criteria: inclusion criteria:

 Patients in the intensive care unit using ventilator

Exclusion criteria: :

 Asthma, COPD, non-ventilated patients

:

 Asthma, COPD, non-ventilated patients


A Phase 3 Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Japanese Elderly Adults Aged 65 Years Old and Older

Summary: The purpose of this study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine compared to a single dose of 23-valent pneumococcal polysaccharide vaccine in Japanese adults aged 65 years old and older.
Inclusion criteria: inclusion criteria:

 Healthy Japanese male and female adults aged 65 years old and older at time of enrollment. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of the study vaccine, are eligible.

 Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study or for at least 28 days after the last dose of the study vaccine whichever is longer.

Exclusion criteria: :

 History of severe adverse reaction including hypersensitivity such as anaphylaxis associated with a vaccine or vaccine component.

 Previous vaccination with any licensed or experimental pneumococcal vaccine.

 Documented Streptococcus pneumoniae infection within the past 5 years.

 Residence in a nursing home, long-term care facility, or other institution or requirement of semiskilled nursing care.

['13-valent pneumococcal conjugate vaccine', '23-valent pneumococcal polysaccharide vaccine']

['Pneumococcal Vaccines', 'Pneumococcal Conjugate Vaccine']

Pneumococcal Vaccines
Pneumococcal Conjugate Vaccine


Cerebral Near Infrared Spectroscopy During Blood Sampling From a Peripheral Artery Catheter in Preterm Infants

Summary: Preterm infants often need peripheral artery catheters for invasive blood pressure recording and to facilitate blood sampling. Near infrared spectroscopy is a method to evaluate cerebral oxygenation and as well as cerebral blood flow. Sampling procedures with identical sampling volumes are performed at a short (40 seconds) and a long (70 seconds) time intervall while changes of cerebral oxygenation are measured. The investigators hypothesise that slower sampling decrease changes in cerebral blood flow.
Inclusion criteria: inclusion criteria:

 Preterm infant (Gestational Age <37+0)

 Peripheral arterial catheter (ulnary or radial artery)

Exclusion criteria: :

 Complex organ malformation

['Cerebral Oxygenation', 'Cerebral Blood Flow', 'Prematurity']

Cerebral Oxygenation
Cerebral Blood Flow
Prematurity


Feasibility and Validity of A Novel Computer Based Battery of Assessments in the Elderly

Summary: While standard pencil-and-paper test have continued to be useful for the monitoring of cognition, mood, and life space (LS) in the elderly they do have considerable limitations. Use of these pencil-and-paper tests requires that individuals come to the clinic for assessments, which results in significant clinical costs and practical limitations in the conducting of assessments in large numbers of individuals, and provides a time consuming and non-automated means of quantifying and recording changes in brain function. It is increasingly recognized that there is a need to develop valid and reliable computer based assessments to allow for the remote assessment of cognition, mood, and other parameters. Development of computerized based assessments will significantly increase the scale, scope, and speed with which cognition and mood can be measured in the elderly.~Helping Hands Technology LLC (HHT) has developed a number of web based assessments of cognition, mood, and LS. These new computerized assessments will be developed using new technology, and are based on the general principles found in existing pencil-and-paper based assessments of cognition, mood, and LS. In addition, HHT is developing proprietary means of reporting the results of the computerized assessments in an easy to use narrative format. This study will focus on quantifying the feasibility and validity of using HHT computerized assessments.
Inclusion criteria: inclusion criteria:

 Men and woman between the ages of 60-85, inclusive

 Cognitive function/impairment within appropriate ranges for the study (Mini-Mental State Exam scores of 10-30, inclusive)

Exclusion criteria: :

 Unable to complete computerized and standard pencil-and-paper based assessments

['HHT-G', 'HHT-D', 'Geriatric Depression Scale (DGS)', 'MMSE']

HHT-G
HHT-D
Geriatric Depression Scale (DGS)
MMSE

['Computerized Assessment Feasibility and Validity']


Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood Asthma (VDAART)

Summary: Vitamin D supplementation given to pregnant women will prevent asthma in their offspring and children.
Inclusion criteria: inclusion criteria:

 Personal history of asthma, eczema, allergic rhinitis or a history of asthma, eczema, allergic rhinitis in the biological father of the child

 Gestational age between 10 and 18 weeks at the time of randomization

 Maternal age between 18 and 39 years

 Not a current smoker

 English or Spanish speaking

 Intent to participate for the full 4 years (through Pregnancy and then until the 3rd birthday of the child)

Exclusion criteria: :

 Not meeting inclusion criteria

 Gestational age greater than 18 weeks

 Presence of chronic medical conditions

 Taking vitamin D supplements containing more than 2000 IU/day of vitamin D3

 Multiple gestation pregnancy (twins, triplets)

 Pregnancy achieved by assisted reproduction techniques (e.g., IUI, IVF)

['Vitamin D 3 cholecalciferol', 'Vitamin D3']


The Effect of an Urban Sanitation Intervention on Child Health

Summary: The purpose of this study is to determine the health impact of a basic sanitation intervention in Maputo, Mozambique.
Inclusion criteria: inclusion criteria:

 Children normally resident in households with access to new shared sanitation (the intervention) as selected by implementing organisation (WSUP) or control children normally resident in households sharing existing shared sanitation within geographically delimited project bounds and meeting WSUP site selection criteria (including number of people served)

Exclusion criteria: :

 Refusal to participate