ExploR® Modular Radial Head Data Collection

Summary: The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the ExploR® Modular Radial Head. This data collection effort will document the clinical outcomes of the radial head.
Inclusion criteria: inclusion criteria:

 The inclusion criteria will be the same as the indications stated in the FDA cleared (510(k) K040611) and (510(k) K051385) labeling for the device.

 Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:

 Joint destruction and/or subluxation visible on x-ray

 Resistance to conservative treatment

 Primary replacement after fracture of the radial head

 Symptomatic sequelae after radial head resection

 Revision following failed radial head arthroplasty

 The device is intended for single use with or without bone cement.

 Modular Radial Head replacement prostheses have received FDA clearance for cemented and non-cemented application.

 Patient selection factors to be considered include: 1) need to obtain pain relief and improve function, 2) ability and willingness of the patient to follow instructions, including control of weight and activity levels, 3) a good nutritional state of the patient, and 4) the patient must have reached full skeletal maturity.

Exclusion criteria: :

 The

['Degenerative Conditions of the Radial Head/Neck', 'Post-traumatic Conditions of the Radial Head/Neck']


Screening for Lung Cancer in Older Patients (PLCO Screening Trial)

Summary: This clinical trial studies whether screening methods used to diagnose cancer of the prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening tests may help doctors find cancer cells early and plan better treatment for lung cancer.
Inclusion criteria:
Exclusion criteria: :

 Men and women who at the time of randomization are less than 55 or greater than or equal to 75 years of age

 Individuals undergoing treatment for cancer at this time, excluding basal-cell and squamous-cell skin cancer

 Individuals with known prior cancer of the colon, rectum, lung, prostate (men only) or ovary (women only)

 This includes primary or metastatic PLCO cancers

 Individuals with previous surgical removal of the entire colon, one lung, or the entire prostate (men only)

 Until October 1996, women with previous surgical removal of both ovaries were excluded from the trial. In order to increase the enrollment of women into the trial, beginning in October 1996, these women were no longer excluded for this reason.

 Individuals who are participating in another cancer screening or cancer primary prevention trial

 Males who have taken Proscar/Propecia/finasteride in the past 6 months

 NOTE: Individuals who are already enrolled in the trial when their physician prescribes finasteride are not prevented from taking this medication. As a result, these participants will continue to be screened and followed just as those participants who are not on finasteride.

 NOTE: Men who are taking Tamoxifen are not excluded from any part of the PLCO Screening Trial.

 Prior to April 1, 1999 women were excluded from the trial if they were currently taking or had taken Tamoxifen or Evista\Raloxifene in the past 6 months. As of April 1999 based on a decision from the PLCO Ovary Subcommittee, women who have or are currently taking Tamoxifen or Evista\Raloxifene are not excluded from participation.

 Individuals who are unwilling or unable to sign the informed consent form

 Males who have had more than one PSA blood test in the past three years

 Individuals who have had a colonoscopy, sigmoidoscopy, or barium enema in the past three years

['Screening Questionnaire Administration', 'X-Ray Imaging']

Screening Questionnaire Administration
X-Ray Imaging


Randomized Controlled Trial of Labetalol Versus Hydralazine for Severe Hypertension in Obstetric Patients.

Summary: Severe Hypertension in pregnancy demands urgent treatment because of high mortality & morbidity in obstetric patients. Hydralazine, the most commonly used agent, causes sudden hypo tension and tachycardia. Labetalol because of combined α and β blocking effects lacks these side effects. Most recent Cochrane systematic review on use of anti hypertensive drugs in pregnancy related hypertension, could include only four trials of comparison of Hydralazine with Labetalol. Three out of total 4, had sample size ranging from 20-60 obstetric, with total sample size ranging from 19-30. Only 2 trials reported severe persistent hypertension.This review could not conclude about comparative effects due to insufficient data and suggested that further trials should compare Hydralazine with Nifedipine or labetalol, and to report severe persistent hypertension and adverse feto-maternal effects.~OBJECTIVES:1) To compare efficacy and severe persistent hypertension after intravenous Labetalol versus Hydralazine, within maximum 5 drug boluses, in obstetric severe hypertensive patients at Civil Hospital Karachi.~2) To compare immediate adverse maternal and fetal effects in the study group. 3) Furthermore, to assess response to treatment, in terms of patient and disease characteristics.~STUDY DESIGN: Randomized controlled trial.~SETTING & DURATION OF STUDY: Gynaecology Unit I, Civil hospital Karachi, from Oct 2012 to Sep 2014~METHODS: Total one hundred eighty-four patients with, severe hypertension (systolic blood pressure(S.B.P)≥160 and/or diastolic blood pressure(D.B.P) ≥110 mm Hg) at greater than 28 weeks of pregnancy or upto 72 hours after delivery, were enrolled and randomly allocated to drug A or B. At enrollment, 94 patients were allocated to Labetalol to 96 to Hydralazine through simple randomization. Since six cases were excluded due to insufficient information( 2 from group A and 4 from group B) so finally data of 92 patients in each group was analyzed. Primary outcome measures were lowering of S.B.P to <160 mm Hg and D.B.P <110 mm Hg (efficacy)and severe persistent hypertension. In addition maternal hypo tension, tachycardia, bradycardia, adverse effect on fetal heart, still birth and neonatal bradycardia were measured.~EXPECTED OUTCOME: Efficacy, severe persistent hypertension and side effects of Labetalol versus Hydralazine, in our population were determined.~Assessment of response to Drug A and B, will help in choosing a drug for different patient and disease characteristics.
Inclusion criteria: inclusion criteria:

 INCLUSIONS CRITERIA Pregnant or post partum patients with systolic blood pressure ≥160mm of Hg or diastolic BP ≥110 mm Hg, on repeat measurement of blood pressure after 15 minutes of rest, meeting following inclusion criteria will be included.

 Pregnancy greater than 28 wks(gestational age determined by ultrasound prior to 20 weeks which if unavailable then by uterine size at first prenatal visit or by last menstrual period) with gestational hypertension, severe preeclampsia, chronic hypertension, chronic hypertension with superimposed preeclampsia, eclampsia and unclassified hypertension.

 Postpartum patients, upto 72 hours after delivery, diagnosed as gestational hypertension, severe preeclampsia, chronic hypertension, chronic hypertension with superimposed preeclampsia, eclampsia and unclassified hypertension.

 Patients with singleton or multiple pregnancy.

 Patients of all ages and parity.

Exclusion criteria: :

 Patients with asthma.

 Patients with cardiac failure and heart block.

 Patients with pacing device in place or any type of cardiac arrhythmia. -

['Hypertension, Pregnancy Induced', 'Hydralazine Adverse Reaction', 'Pre-eclampsia', 'Pre-eclampsia Superimposed Pre-existing Hypertension']


Muscatine Heart Study

Summary: To conduct longitudinal and cross-sectional studies of risk factors for coronary heart disease and hypertension in school age children and adults who had been examined in previous screens.
Inclusion criteria: No eligibility criteria
Exclusion criteria:

['Cardiovascular Diseases', 'Coronary Disease', 'Hypertension', 'Heart Diseases']

Cardiovascular Diseases
Coronary Disease
Hypertension
Heart Diseases


Protracted Effect of Combined Nerve Blocks After Total Knee Arthroplasty

Summary: Purpose:~The purpose of this study is to evaluate the postoperative analgesic effect of a combined Saphenous nerve block and Obturator nerve block with local infiltration analgesia in the tissue around the knee after surgery with knee replacement. In the combined nerve blocks we use a mixture of Bupivacaine, Adrenaline, Clonidine and Dexamethasone (protracted mixture) and the local infiltration consist of Ropivacaine, Adrenaline and Toradol. Our hypothesis is that the combined nerve blocks with protracted mixture prolongs block duration, reduces pain and reduces the need for morphine and thus reduce side effects such as nausea, vomiting and lethargy compared to the current treatment with local infiltration analgesia.~Background:~Nerve blocks as analgesic treatment after orthopedic surgery is a recognized and proven procedure. The nerve blocks have the disadvantage that not only do they anesthetize the sensory nerve fibers but also the nerve fibers to the muscles of the leg. The Saphenous nerve block causes only stunning of sensory nerves to the knee region. The Obturator nerve block causes both stunning of the sensory nerves to the knee region and the thighs inward leading muscles, and does not affect the patient's mobilization capacity.~Both blocks are known to be a good addition to the analgesic treatment. Bupivacaine is a well-known local anesthetic. Adrenaline, Clonidine and Dexamethasone have also been used in other studies, in addition to the local anesthetic agent, and has been shown to prolong the effect of the nerve block. Saphenous and Obturator nerve block with all four drugs Bupivacaine, Adrenaline, Clonidine and Dexamethasone has not been systematically investigated in knee replacement surgery, and it is not known whether this method will provide better pain treatment.~Method~The patient can receive one of three treatments, determined randomly:~A. Saphenous and Obturator nerve block with active anesthetics (Bupivacaine, Adrenaline, Clonidine, Dexamethasone) and local block around the knee joint with placebo medicine (normal saline).~B. Saphenous block with active anesthetics and both Obturator nerve block and local block around the knee joint with placebo medicine (normal saline).~C. Both block with placebo medicine (normal saline) and local block around the knee joint with effective local anesthetic.~Neither patient, investigator or staff around the patient will have knowledge of which treatment the patient has received.~The blocks will be injected before the operation and local infiltration around the knee joint will be given by the surgeon during the operation.
Inclusion criteria: inclusion criteria:

 Age > 50 years

 Patients set to cemented Total knee arthroplasty in spinal block

 Patients who have given written informed consent to participate in the study after having understood the contents of the protocol and limitations fully

 Illness score 1-3

Exclusion criteria: :

 Patients who can not cooperate with the investigation

 Patients who do not understand or speak Danish

 Patients receiving immunosuppressive therapy

 Patients with a treatment-dependent diabetes mellitus

 Patients with known neuropathy in the lower limbs

 Allergy to those drugs used in the study

 Alcohol and / or drug abuse - the investigator's opinion

 Patients who can not tolerate Non steroid analgesic drugs

 Use of strong opioid several times a day (morphine, ketogan, Oxynorm, methadone, fentanyl)

['Dexamethasone 4 mg + Clonidine 75 microgram + Marcaine 90 mg + Adrenaline 90 microgram', 'Dexamethasone 2 mg + Clonidine 37,5 microgram + Marcaine 45 mg + Adrenaline 45 microgram', 'Ropivacaine + Toradol + Adrenaline']

['Pain', 'Total Knee Arthroplasty', 'Nerve Blocks']

Pain
Total Knee Arthroplasty
Nerve Blocks


Prediction of Acute Postoperative Pain and Analgesic Consumption

Summary: Pain is an expected part of surgical recovery but effective pain management remains challenging. The high variability in postoperative pain experience and analgesic treatment response between patients is part of the challenge. Few studies have yet combined preoperative assessment of responses to experimental pain with measurements of cognitive and emotional processes in the prediction of postoperative pain.~We hypothesize, that preoperative evoked brain potentials (using standard electroencephalographic brain imaging), endogenous pain inhibition capacity (conditioned pain modulation), responses to pressure/thermal pain stimulation, and/or situational pain-related catastrophic thinking are useful clinical predictors of postoperative pain and analgesic consumption.
Inclusion criteria: inclusion criteria:

 Elective minimally invasive surgical correction of funnel chest (pectus excavatum

 age ≥15 years.

Exclusion criteria: :

 Previous thoracic surgical interventions

 Presence of diseases affecting the central and/or peripheral nervous system

 Presence of chronic pain conditions

 Inability to speak and/or understand Danish

 Inability to understand and participate in the experimental pain session

 Presence of psychiatric disorders

 History of frostbite in the non-dominant upper limb

 Presence of sores or cuts on non-dominant upper limb

 Presence of cardiovascular disease

 History of fainting and/or seizures

 Presence of fractures of the non-dominant upper limb

 Presence of Reynaud's phenomenon.

 Secondary exclusions included:

 Insensitivity to experimental cold pressor pain

 Lack of epidural catheter placement

 Re-operation


Celecoxib in Preventing Colorectal Cancer in Young Patients With a Genetic Predisposition for Familial Adenomatous Polyposis

Summary: RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of celecoxib may keep polyps and colorectal cancer from forming in patients with familial adenomatous polyposis.~PURPOSE: This randomized phase I trial is studying the side effects and best dose of celecoxib in treating young patients with a genetic predisposition for familial adenomatous polyposis.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Diagnosis of familial adenomatous polyposis (FAP) based on genetic predisposition testing

 Genotype-positive FAP (pathologic Adenomatous polyposis coli (APC) mutation)

 No attenuated FAP genotype, defined by any of the following:

 Mutation at the 5' end of APC and exon 4

 Exon 9-associated phenotypes

 3' region mutations

 Has an intact colon

 No requirement for colectomy

 Parent(s) do not desire colectomy (regardless of adenoma burden)

 Colorectal adenoma burden as assessed by baseline colonoscopy

 No diagnosis of severe dysplasia or greater

 No more than 10 adenomas ≥ 1 cm

 No more than 100 adenomas of any size

 No evidence of anemia (hematocrit < 33%)

 No new diagnosis of carcinoma

 PATIENT CHARACTERISTICS:

 White Blood Count (WBC) > 3,000/μL

 Platelet count > 100,000/μL

 Hemoglobin > 10.0 g/dL

 Aspartate aminotransferase/alanine aminotransferase (AST/ALT) < 1.5 times upper limit of normal (ULN)

 Alkaline phosphatase < 1.5 times ULN

 Total bilirubin < 1.5 times ULN

 Creatinine < 1.5 times ULN

 Not pregnant or nursing

 Negative pregnancy test

 Fertile patients must use effective contraception

 No history of hypersensitivity to COX-2 inhibitors, sulfonamides, NSAIDs, or salicylates

 No history of peptic ulcer disease

 No significant medical or psychiatric problem that, in the opinion of the principal investigator, would make the patient a poor candidate for the study

 No other unacceptable clinical risk (e.g., previously unknown bleeding diatheses)

 No invasive carcinoma within the past 5 years

 PRIOR CONCURRENT THERAPY:

 More than 3 months since prior investigational agent

 More than 6 months since prior chemotherapy

 No prior radiotherapy to the pelvis

 At least 3 months since prior NSAIDs (at any dose) at a frequency of ≥ 3 times/week

 At least 1 month since prior NSAIDs (at any dose) at a frequency of < 3 times/week

 At least 1 month since prior nasal steroids

 Concurrent Nonsteroidal Antiinflammatory Drugs (NSAIDs) allowed provided they are administered ≤ 5 times per month

 Concurrent orally inhaled steroids allowed provided they are administered for ≤ 4 weeks over a 6-month period

 Concurrent oral or intravenous (IV) corticosteroids allowed provided they are administered for ≤ 2 consecutive weeks over a 6-month period

 Concurrent proton pump inhibitors to treat gastric reflux allowed

 No concurrent nasal steroids except mometasone (Nasonex)

 No concurrent fluconazole, lithium, or adrenocorticosteroids
Exclusion criteria:

['Colorectal Cancer', 'Precancerous Condition']

Colorectal Cancer
Precancerous Condition


Spontaneous Intracranial Hypotension Treatment SIHT

Summary: Spontaneous intracranial hypotension (SIH) is an infrequent disease, related to a leak of cerebrospinal fluid. There are not controlled studies for this treatment.The main of this study is to demonstrate the superiority of the Trendelenburg position compared to supine position during 24 hours after an epidural blood patch for a spontaneous intracranial hypotension
Inclusion criteria: inclusion criteria:

 18 years or more

 No contraindication for BPE

 Severe or moderate headache within 15 min standing, mild or no headache after 15 min bed rest

 Headache from 5 to 28 days

 Normal or evidence of low CSF on MRI

 Signed informed consent

Exclusion criteria: :

 Known dural leak in the previous 2 months the onset of headache

 Abnormal MRI

 First BPE for SIH

 The patient has participated in another clinical trial than can interact with the evaluation

 Contraindication of Trendelenburg position

['24 hours Trendelenburg position', '24 hours bed rest', 'EBP']

24 hours Trendelenburg position
24 hours bed rest
EBP


Functional and Neurochemical Brain Changes Bipolar Depression

Summary: The purpose of the research is to study brain structure, function and chemistry of patients with bipolar disorder who are receiving quetiapine or lithium, in order to better understand who benefits from treatment and why they respond to medications.
Inclusion criteria: inclusion criteria - Depressed bipolar patients (N=100; 15-20 patients/year):

 Patients will meet DSM-IV criteria for type I bipolar disorder, depressed, as determined by structured interview and best-estimate diagnostic procedures.138

 Patient has experienced a maximum of three documented affective episodes.

 Patient has been off medications for one week prior to study enrollment.

 Patient has a Hamilton Depression Rating Scale (HDRS) total score ≥20

 Patient is between the ages of 12 and 35 years.

Exclusion criteria: : All subjects will be excluded from participation for the following reasons:

 Any chemical use disorder within 3 months.

 Any history of significant suicidality that would place the patient at risk to participate in this protocol.

 Current score ≥3 on item 3 of the HDRS-17 (Suicide Item)

 Any medical or neurological disorder that could influence fMRI results.

 A history of mental retardation or an estimated IQ total score <85.

 An MRI scan is contraindicated in the subject for any reason.

 The patient lives >100 miles from the University of Cincinnati or cannot attend follow-up visits.

 Meets DSM-IV criteria for a bipolar mixed episode


Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema

Summary: The investigators will conduct a double-blind, randomized controlled trial comparing the safety and effectiveness of ecallantide to conventional therapy. A rescue cross-over design will be used such that patients failing to improve on standard therapy will additionally be treated with ecallantide. Therefore, a historical control cohort will be enrolled for analysis of secondary endpoints. In addition, since some patients treated with conventional therapy may improve rapidly and therefore not be eligible for inclusion in the study, the investigators will enroll these patients as an observational arm to enable the conduct of sensitivity analysis.
Inclusion criteria: inclusion criteria:

 Males and females of any race or ethnicity 18 or older. The locations of the study will permit all racial and ethnic distribution in the study

 Must currently be on an ACE inhibitor

 Presenting with ACE induced angioedema within 12 hours after onset. This is to be documented in the source document and CRF

 All females of childbearing age must have a negative pregnancy test prior to administration of the study drug.

Exclusion criteria: :

 Participation in another investigational study within 30 days prior to enrollment

 Patients who improve on conventional (standard of care) therapy

 Patients previously treated with ecallantide

 Hypersensitivity to ecallantide

 Pregnancy or breast feeding

 Other definable causes of angioedema (i.e., hereditary or acquired angioedema)

 Patients receiving C-1 inhibitor as prophylaxis

 Treatment requiring tranexamic acid, and epsilon-aminocaproic acid

 Receiving fresh frozen plasma within 3 days prior to enrollment

['ecallantide - Kallikrein inhibitor that blocks the production of bradykinin']


Assessment of Peritoneal Immune Response in Patients With Severe Intra-abdominal Sepsis Managed With Laparostomy and Vacuum Assisted Closure (VAC)

Summary: Protocol Synopsis~Protocol title: Assessment of peritoneal immune response in patients with severe intra-abdominal sepsis managed by laparostomy and VAC~Purpose: Assessment of peritoneal immune response in patients with severe intra-abdominal sepsis~Design: Prospective, single-center study~Patient Population: Male or female adults (>18 years) with severe intra-abdominal sepsis~No. of Subjects: 60 patients divided into two groups, 30 patients with severe intra-operative sepsis and 30 patients without sepsis scheduled to undergo major abdominal operations (middle line incision>15cm). The study is estimated up to 2 year to enroll~Duration of Follow-up: Follow-up will be performed daily while hospitalized, until patient discharged or deceased.~Endpoints:~To measure the peritoneal cytokines levels in patients with severe intra-abdominal sepsis.~To correlate the cytokines levels in the abdominal cavity and the serum plasma.~To correlate cytokines response in serum plasma and peritoneal fluid with mortality and morbidity.~To compare cytokines results in serum plasma and peritoneal fluid between patients with severe intra-abdominal sepsis and patients undergoing major laparotomy without sepsis.~To assess the microbial load in the abdominal cavity in patients with severe sepsis.~To assess the biofilm formation in VAC polyurethane sponge.
Inclusion criteria: inclusion criteria:

 Patient > 18 years old

 30 patients with severe abdominal sepsis in order to form the study group and 30 patients without sepsis undergoing major elective surgery (middle line incision >15cm) to form the control group.

 Patient or relatives signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures

Exclusion criteria: :

 Patient's Manheim Peritonitis Score < 29

 Patient's pre-operative SOFA score < 6

 The use of other temporary abdominal closure system

 Decease before the first VAC dressing change

 Patient is participating in another clinical trial which may affect this study's outcomes

 Patients with immune deficiency

 Documented seropositivity for human immunodeficiency virus (AIDS)

 Patient receiving steroids treatment for other medical condition

 Patient receiving chronic anti-inflammatory treatment

 Patient receiving anti- TNF treatment

 Pre-existing parechymal liver disease ( Cirrhosis - Child-Pugh C)

 Pregnancy


A Cluster Randomized Trial to Assess the Impact of Opinion Leader Endorsed Evidence Summaries on Improving Quality of Prescribing for Patients With Chronic Cardiovascular Disease

Summary: BACKGROUND: Although much has been written about the influence of local opinion leaders on clinical practice, there have been few controlled studies of their effect, and almost none have attempted to change prescribing in the community for chronic conditions such as congestive heart failure (CHF) or ischemic heart disease (IHD). These two conditions are common and there is very good evidence about how to best prevent morbidity and mortality - and very good evidence that quality of care is, in general, suboptimal. Practice audits have demonstrated that about half of eligible CHF patients are prescribed ACE inhibitors (and fewer still reaching appropriate target doses) and less than one-third of patients with established IHD are prescribed statins (with many fewer reaching recommended cholesterol targets). It is apparent that interventions to improve quality of prescribing are urgently needed.~HYPOTHESIS: An intervention that consists of patient-specific one-page evidence summaries, generated and then endorsed by local opinion leaders, will be able to change prescribing practices of community-based primary care physicians.~DESIGN: A single centre randomized controlled trial comparing an opinion leader intervention to usual care. Based on random allocation of all physicians in one large Canadian health region, patients with CHF or IHD (not receiving ACE inhibitors or statins, respectively) recruited from community pharmacies will be allocated to intervention or usual care. The primary outcome is improvement in prescription of proven efficacious therapies for CHF (ACE inhibitors) or IHD (statins) within 6 months of the intervention.
Inclusion criteria: inclusion criteria:

 Patients with HF or IHD who are not currently taking the study medications of interest (ACE inhibitors/angiotensin receptor blockers for HF or statins for IHD) and whose primary care physicians are part of the study population

Exclusion criteria: :

 Patients who are unable or unwilling to give informed consent,

 previously taken the study medications according to dispensing records

 allergy or intolerance to study medications

 residents of long-term care facilities

 unable to confirm a diagnosis of either HF or IHD

 primary care physician has already contributed 5 patients to the study

['Opinion leader generated and endorsed evidence summaries']

['Coronary Disease', 'Ischemic Heart Disease', 'Heart Failure']

Coronary Disease
Ischemic Heart Disease
Heart Failure


Quetiapine SR and Divalproex Sodium ER in the Treatment of Anxiety in Bipolar Disorder With Panic Disorder and/or GAD

Summary: The specific aim of this study is to evaluate the efficacy, tolerability, and safety of quetiapine SR monotherapy and divalproex sodium ER monotherapy in comparison to placebo in the treatment of ambulatory bipolar disorder with co-morbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety.
Inclusion criteria: inclusion criteria:

 Subjects must be at least 18 years of age and not older than 65

 Subjects must have lifetime bipolar I, II, or not otherwise specified (NOS) disorder as defined by DSM-IV TR (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision) criteria

 Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV, criteria (except clause does not occur exclusively during a mood disorder of Criterion F for GAD)

 Subjects' bipolar symptoms must be no more than moderate in severity, defined as a CGI-BP< 4

 Subjects' anxiety symptoms must be at least moderate in severity, defined as a CGI-S > 4

 Subjects must not be receiving regular mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for at least one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for at least four weeks prior to baseline

 Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained

 If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, barrier methods, intrauterine device) for at least one month prior to study entry and throughout the study

Exclusion criteria: :

 Subjects who do not have lifetime bipolar disorder by DSM-IV-TR criteria

 Subjects who do not have lifetime panic disorder or generalized anxiety disorder by DSM-IV-TR criteria

 Subjects who are receiving treatment with an anti-manic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication

 Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP>5)

 Subjects whose anxiety symptoms are presently less than moderately severe (CGI-S<3)

 Subjects with clinically significant suicidal or homicidal ideation.

 Subjects with a current DSM-IV TR Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV TR diagnosis of a substance dependence disorder within the past six months; a lifetime DSM-IV TR psychotic disorder (e.g., schizophrenia or schizoaffective disorder)

 Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurological, or hematological disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo-or hyperthyroidism unless stabilized on thyroid replacement > 3 months

 Subjects with a clinically significant abnormality in their pre-study physical exam, vital signs, EKG, or laboratory tests

 Subjects who are allergic to or who have demonstrated hypersensitivity or intolerance to either of the active study medications

 Women who are pregnant or nursing

 Subjects who have received an experimental drug or used an experimental device within 30 days

 Subjects who have a history of neuroleptic malignant syndrome

 A patient with diabetes mellitus (DM) fulfilling one of the following criteria:

 Unstable DM defined as enrollment glycosylated hemoglobin (HbAlc) >8.5%

 Admitted to hospital for treatment of DM or DM related illness within the past 12 weeks

 Not under physician care for DM

 Physician responsible for patient's DM care has not indicated that the patient's DM is controlled

 Physician responsible for patient's DM care has not approved the patient's participation in the study

 Has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the 4 weeks before randomization. For thiazolidinediones (glitazones) this period should not be less than 8 weeks before randomization

 Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks Note: If a patient with DM meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study

['quetiapine SR', 'divalproex sodium ER', 'placebo']

quetiapine SR
divalproex sodium ER
placebo

['Bipolar Disorder', 'Panic Disorder', 'Generalized Anxiety Disorder']

Bipolar Disorder
Panic Disorder
Generalized Anxiety Disorder


Adjunctive Isradipine for the Treatment of Bipolar Depression

Summary: This study investigates the medication isradipine, which is currently approved by the FDA to treat high blood pressure, in the treatment of depression in bipolar disorder. Isradipine or placebo (contains no active medication) will be used as an add-on to lithium, valproate, and/or atypical antipsychotics for individuals currently experiencing a major depressive episode. Our hypothesis is that isradipine will be superior to placebo in improving depressive symptoms.
Inclusion criteria: inclusion criteria:

 Age 18-65

 written informed consent

 meets Diagnostic and Statistical Manual-IV (DSM-IV) criteria (by Structured Clinical Interview for Diagnostic and Statistical Manual - IV -I/P (SCID)) for bipolar I disorder, current episode depressed

 Montgomery-Asberg Depression Scale (MADRS) score of at least 20 (i.e., moderate depression) and no greater than 34 (i.e., severe depression) at screen and baseline visit

 Young Mania Rating Scale (YMRS) score < 12 at screen and baseline visit

 currently treated with a lithium preparation (carbonate or citrate) at stable dose for at least 4 wks with level >0.6 and <1.0; and/or valproate at stable dose for at least 4 wks at level >60 and <110; and/or other atypical antipsychotic at stable dose for at least 4 weeks (at least minimum FDA-labeled dose)

 Caucasian by self-report - please see discussion below

Exclusion criteria: :

 Psychotic features in the current episode, as assessed by YMRS item #8 > 6 [where treatment guidelines urge use of antipsychotics that may confound isradipine results]

 felt by the study clinician to require inpatient hospitalization for adequate management (to include serious suicide or homicide risk, as assessed by evaluating clinician)

 3 or more failed pharmacologic interventions in the current major depressive episode, excluding lithium/valproate/other atypical antipsychotic [response rates for these subjects is likely to be extremely low and would require a substantially larger-scale study to identify treatment effects]

 obsessive-compulsive disorder, or any diagnosis of a DSM-IV anxiety disorder where the anxiety disorder and not bipolar disorder is the primary focus of clinical attention

 current substance use disorder other than nicotine, by SCID-I/P

 a primary clinical diagnosis of a personality disorder, or comorbid diagnosis of antisocial or borderline personality disorder

 pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy)

 women who are breastfeeding

 other unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease, based on review of medical history, physical examination, and screening laboratory tests (this will include any clinical or laboratory evidence of hypothyroidism; if maintained on thyroid medication must be euthyroid for at least 1 month before Visit 1)

 history of hypertension or current treatment for hypertension

 current use of isradipine or history of anaphylactic reaction or intolerance to isradipine or any component of the preparation

 ECG abnormalities at entry: prolonged QTC interval or complete or incomplete bundle branch block

 patients who have taken an investigational psychotropic drug within the last 3 months

 patients receiving other excluded antipsychotics or antidepressants within 2 weeks prior to study entry

 patients requiring continued treatment with excluded medications (see below).

 Excluded medications: antidepressants, antipsychotics, and anticonvulsants (other than valproate), which could influence calcium signaling or impact mood; other calcium channel blockers; any other antihypertensive because of the risk of cause hypotension; any other drug known to interact with isradipine. Benzodiazepines or other sedative-hypnotic agents (e.g., zolpidem) may not be initiated after study entry; subjects requiring these agents will be removed from the study. Allowed: Sedative-hypnotic agents if dosage has been stable for 4 weeks prior to study entry; thyroid or estrogen replacement provided dosage has been stable for 3 months. Acceptable anticonvulsants include lamotrigine, valproate, gabapentin, topiramate, oxcarbazepine, carbamazepine.


The Effect of Toremifene Treatment to the Magnetic Resonance Imaging (MRI) Findings in Premenstrual Mastalgia

Summary: The purpose of this study is to determine the effect of toremifene treatment to the MRI findings of the breast in women suffering from premenstrual mastalgia.
Inclusion criteria: inclusion criteria:

 Premenstrual mastalgia

 Age 20-45 years

 Reliable non-hormonal contraception

Exclusion criteria: :

 Pregnancy

 Breast cancer or uterine corpus cancer

 Unexplained menstrual disorders

 Serious health problems

 Hormonal contraception, including hormonal IUD trade name Mirena

 Oestrogen and/or progestin treatment

 Hysterectomy and/or oophorectomy or radiation therapy

 Artificial cardiac pacemaker/metallic prostheses


Study of Methotrexate in Lupus Erythematosus

Summary: The treatment of systemic lupus erythematosus (SLE) has been aimed at decreasing mortality and morbidity because the etiology of the disease is unknown. The general aim of this multicentre randomized placebo-controlled trial of low dose intermittent methotrexate with folic acid is to establish whether methotrexate shows efficacy and safety in controlling disease activity in SLE and preventing flares in disease activity or development of end-organ damage. A second aim will be to document the steroid sparing effect of methotrexate in SLE. A Third aim will be to measure toxicity and utility of methotrexate with folic acid and to perform effectiveness and utility analyses.
Inclusion criteria: inclusion criteria:

 men and women with diagnosis of SLE

 18 years and above

 negative pregnancy test for female subjects of child-bearing age and must accept not to attempt to get pregnant during the period of the study

 Subject with active disease as defined by SLAM of at least 8

 SLICC/ACR damage index of less or equal to 15

 Subject must be on stable does of NSAIDs, prednisone, or antimalarial (chloroquine sulfate or hydroxychloroquine) at least 4 weeks preceding the study

 subjects can be under other medications as long as condition or treatment will not interfere with the experimental medications and assessments

 must understand either French or English and can give written informed consent

Exclusion criteria: :

 previous history of hypersensitivity or intolerance to methotrexate or folic acid

 total SLAM of less than 8 or total SLICC/ACR score of more than 15.

 history of medical non-compliance or inability to comply with instructions

 subject who have received intra-articular or intramuscular corticosteroids in the four weeks prior to study entry.

 clinically significant acute or chronic liver disease with the exception of autoimmune liver disease

 alcohol use in excess of 2 ounces of 100 proof liquor or its equivalent/week

 insulin requiring diabetes mellitus with morbid obesity

 renal impairment such that the serum creatinine is more than or equal to 175 umol/I (SI units) or 2.0 mg/dl

 interstitial lung disease as defined by an abnormal chest x-ray or decrease diffusion capacity (DLCO < 70% of predicted) without evidence of pulmonary hypertension.

 WBC count ,3,000/ cubic mm. and/or platelet count ,80,000/ cubic mm.

 prior use of methotrexate to treat SLE

 use of sulfa drugs that may potentiate the folate antagonistic effects of MTX

 non-steroidal anti-inflammatory drugs will be allowed throughout the trial unless there is evidence of renal failure or other contra-indications to these drugs. Their con-comitant use with MTX is routine in patients with rheumatoid arthritis.

 use of another cytotoxic or immunosuppressive drug such as cyclophosphamide, azathioprine, chlorambucil, cyclosporin or trimetoprime currently or in the preceding 6 months.

 current participation in any other drug trial or participation in such a trial in the previous one month.

 serologic evidence of infection with HIV

 biologic potential for pregnancy and not utilizing effective means of contraception

 recently (less than 6 months) diagnosed malignancy

 vitamin B12 deficiency


Dementia Phenotypes in Primary Care, Hospital, and National Mortality Registries

Summary: Most patients with dementia in the UK use their local hospitals and general (family) practices throughout their illness. Linked electronic health records from primary care, hospital and death certificates records therefore provide useful information about the diagnosis and prognosis of patients who develop dementia.~In this study we will assess the validity of dementia diagnoses in linked primary care, hospital and death records, by examining the timing of important health transitions in patients with recorded dementia, and we will estimate the lifetime risk of recorded dementia in different age and sex groups
Inclusion criteria: inclusion criteria:

 Patients aged 18 years and over

 Registered with a participating general practice during the study period

 Minimum one year of records prior to study entry meeting CPRD data quality criteria

 Followed on or after 1 January 1997

Exclusion criteria: :

 Patients without recorded gender

 Less than 1 year of follow-up between study entry and date of administrative censoring


Phase 2 Trial of Mesenchymal Stem Cells in Systemic Lupus Erythematosus (MiSLE)

Summary: The purpose of this study is to evaluate the efficacy and safety of mesenchymal stem cells (MSCs) obtained from umbilical cords for the treatment of adults with systemic lupus erythematosus (SLE). The goal of this study is to determine if patients receiving an MSC infusion plus standard of care respond better than patients receiving placebo infusion plus standard of care.
Inclusion criteria: inclusion criteria:

 Patients between 18 and 65 years old, male or female, of any race

 Historical presence of at least 4 of 11 of the ACR Classification Criteria

 Evidence of a positive ANA (≥1:80 titer) or positive dsDNA antibody test within 6 months of screening

 Clinically active SLE determined by SLEDAI score ≥6 and the presence of at least one BILAG A or BILAG B at screening, despite standard-of-care therapy

 If the patient has a BILAG A or BILAG B score in the renal organ system, he/she must have completed at least 6 months of therapy for the current episode of nephritis prior to Screening. Therapy must include at least 6 months of mycophenolate or at least 3 months of cyclophosphamide followed by mycophenolate or azathioprine

 Able and willing to give written informed consent

Exclusion criteria: :

 Active CNS lupus affecting mental status

 Active lupus nephritis requiring dialysis

 Laboratory exclusions: eGFR <30, WBC <2.0/mm3, hemoglobin <8 g/dL, platelet count <30,000/mm3, liver enzymes AST or ALT >4 times upper limit normal.

 Positive testing for HIV, hepatitis B or hepatitis C, tuberculosis (TB), or chest X-ray (CXR) findings consistent with TB or latent fungal infection.

 History of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix

 Pregnant or breast feeding

 A woman of childbearing potential (not post-menopausal or surgically sterile) who is not willing to use adequate contraception

 History of renal transplantation

 Herpes zoster within the past 90 days or any infection requiring hospitalization or intravenous or intramuscular antibiotics within the past 60 days

 Clinically significant EKG or chest X-ray changes

 Any other medical condition, related or unrelated to SLE, that in the opinion of the investigator would render the patient inappropriate or too unstable to complete study protocol

 Use of prednisone >0.5 mg/kg/day (or equivalent corticosteroid) within 1 month of Baseline visit

 Change or addition to immunosuppressant regimen within 3 months of Baseline visit (except corticosteroids); Use of other experimental therapeutic agents within 3 months of Baseline visit

 Having received belimumab within 2 months of Baseline, or having received rituximab or other B cell depleting biologic therapy within 6 months of Baseline.

 Comorbidities requiring corticosteroid therapy

 Current substance abuse or recent (within one year) history of substance abuse

['Low Dose Mesenchymal Stem Cells (MSCs)', 'High Dose Mesenchymal Stem Cells (MSCs)', 'Placebo Infusion']

Low Dose Mesenchymal Stem Cells (MSCs)
High Dose Mesenchymal Stem Cells (MSCs)
Placebo Infusion


Peer Navigator Education in Improving Survivorship Care in African American Breast Cancer Survivors

Summary: This randomized clinical trial studies peer navigator education in improving survivorship care in African American breast cancer survivors. An educational intervention involving peer groups may help to improve the well-being and quality of life (QOL) in breast cancer survivors
Inclusion criteria: inclusion criteria:

 TRIAL SUBJECTS:

 Patient age 18 years or older who self-identifies as African-American

 In early survivorship phase, defined as being 1-12 months post completion of treatment for stage 0-3 breast cancer

 Receiving health care primarily through an health maintenance organization (HMO)

 Patients with metastatic cancer or a second primary cancer, because their medical characteristics (e.g. disease progression) are significantly different

 Breast cancer survivors (BCS) with other major disabling medical, psychiatric, or substance abuse conditions (e.g., anxiety, depression, alcohol/tobacco problems) will be excluded

 PEER NAVIGATORS:

 At least 25 years of age who self-identifies as African-American

 Previously participated in any type of research study

 Has at least high school education

 Has been diagnosed with breast cancer, currently in remission or eradicated

 Belongs to a breast cancer support group

 Has a valid driver's license

 Owns an operational vehicle

 Has access to a personal computer with internet access
Exclusion criteria:

['educational intervention', 'questionnaire administration', 'counseling intervention', 'survey administration', 'quality-of-life assessment']

educational intervention
questionnaire administration
counseling intervention
survey administration
quality-of-life assessment


Melatonin Osteoporosis Prevention Study

Summary: Osteoporosis is one of the most common skeletal disorders. Today in the United States, 10 million individuals have osteoporosis and 34 million more have low bone mass or osteopenia, which places them at an increased risk of some day developing osteoporosis. Of the people affected by this problem, 68% are women.The current thinking on the development of osteoporosis is that the changes in bone turnover that occur with aging play a major factor. Many modalities of treatment are used to prevent the bone loss and increased fracture risk associated with osteoporosis and osteopenia. Melatonin supplementation may be another treatment modality that lowers risk of hip fracture in perimenopausal women. Melatonin can remodel bone in animal models and in culture. Melatonin works through melatonin receptors to form osteoblasts from human mesenchymal stem cells and has been shown to inhibit osteoclast activity in rodents. Melatonin levels have been correlated with modulating bone markers; low nocturnal levels of melatonin correlate with in an increase in bone marker metabolism and osteoporosis. It is been shown that women who have worked night-shifts for greater than 20 years have increased risk for wrist and hip fractures. Night-shift workers have lower nocturnal melatonin levels than people who do not work the night-shift. The addition of exogenous melatonin suppresses bone marker metabolism. In human stem cells taken from bone marrow, melatonin increases the activity of bone-forming cells called osteoblasts. It is hypothesized that melatonin will improve bone health, menopausal quality of life and sleep compared to placebo in perimenopausal women. In particular, the investigators expect perimenopausal women taking melatonin to show an improvement in overall bone health as revealed by a reduction in bone marker turnover since bone resorption increases more so than bone absorption in this population compared to those women taking placebo. We also expect that perimenopausal women taking melatonin to have better control over their menopausal symptoms, better quality of life and less sleep disturbances when compared to their placebo controls since melatonin is known to modulate estrogen levels in the body and regulate sleep. The data from these studies may provide novel and alternative uses for melatonin; in particular its use for the prevention and/or treatment of osteoporosis.
Inclusion criteria: inclusion criteria:

 inclusion criteria include perimenopausal women,

 willingness to participate in the 6-month study, willingness to undergo testing of bone turnover markers before and after the drug therapies and willingness to provide a self-assessment on quality of life and sleep throughout the program.

 Subjects must be willing to take their treatments right before bed and to not to consume alcohol with this medication.

Exclusion criteria: :


Biomarker Differences in Samples From Patients With Undifferentiated Sarcomas

Summary: This clinical trial studies biomarker differences in samples from patients with undifferentiated sarcomas. Studying biomarker in tissue samples from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer
Inclusion criteria: inclusion criteria:

 49 cases of undifferentiated sarcomas from ARST0332 (additional cases may be ascertained as eligible for this current project that also fall under ARST0332 to be requested later if necessary)
Exclusion criteria:


Detection of Vascular Injury in Diabetes Through Eye and Nailfold Data (DIVIDEND) - A Pilot Study

Summary: This project aimed to explore novel methods of detecting small blood vessel disease in a paediatric population with type 1 diabetes mellitus. To do this the techniques of Nailfold capillaroscopy, laser Doppler flowmetry, retinal (eye) vessel analysis and 24-hr Ambulatory Blood Pressure Monitoring were used. Each of these techniques investigated different areas of small blood vessels around the body.~It was hypothesized that in a paediatric population with type 1 diabetes mellitus the novel investigations would be associated with small blood vessel disease and that widespread changes to these blood vessels would be detected through associations between the different novel investigations.
Inclusion criteria: inclusion criteria:

 8-18 years old

 Have a diagnosis of type 1 diabetes mellitus

Exclusion criteria: :

 < 8 years or > 18 years old

 Significant autoimmune rheumatological disease (e.g. lupus or dermatomyositis)

['Video Nailfold Capillaroscopy', 'Ambulatory 24 hr Blood Pressure Monitoring', 'Fundoscopy of eyes', 'Laser Doppler Flowmetry']


Placebo Versus Antibiotics in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)

Summary: The role of antibiotic therapy in patients with COPD remains controversial. While the outcome of several clinical trials is in favour of antibiotics, the quality of these studies in insufficient. In this study the efficacy of doxycycline is compared to placebo. All concommitant treatment (steroids, bronchodilator therapy, physiotherapy) is standardized.~The investigators hypothesize that patients with an acute exacerbations will have a better outcome when treated with antibiotics.
Inclusion criteria: inclusion criteria:

 Acute exacerbation of COPD type I or II according to GOLD

 Ability to perform lung function tests

 Ability to take oral medication

Exclusion criteria: :

 Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception.

 Pretreatment ( > 24 hours) with an antibiotic for the present exacerbation.

 Pretreatment with corticosteroids (>30 mg for more than 4 days) for the present exacerbation.

 Progression or new radiographic abnormalities on the chest X-ray.

 Severe exacerbation that required mechanical ventilation.

 History of bronchiectasis

 Recent or unresolved lung malignancy.

 Other disease likely to require antibiotic therapy.

 Significant gastrointestinal or other conditions that may affect study drug absorption.

 Class III or IV congestive heart failure or stroke.

 Immunodeficiency disorders such as AIDS, humoral immune defect, ciliary dysfunction etc. and the use of immunosuppressive drugs (>30 mg prednisolone maintenance dose or equivalent for more than 4 weeks).

 Cystic fibrosis

 Tuberculosis.

 Impaired renal function (creatinine clearance < 20 ml/min).

['Chronic Obstructive Pulmonary Disease']


Extensive Small Cell Lung Cancer Treatment Using An Investigational Drug Plus Chemotherapy In Chemotherapy-Naive Adults

Summary: This study will gather and compare data about the effectiveness and safety of two different treatments for extensive Small Cell Lung Cancer (SCLC) in patients who have not received previous chemotherapy. One treatment will use an investigational drug in combination with an FDA approved chemotherapy. The other treatment will use a combination of two FDA approved chemotherapy drugs.
Inclusion criteria: inclusion criteria:

 Written informed consent (patient's written understanding of and agreement to participate in this study).

 Patients with confirmed extensive small cell lung cancer (SCLC).

 No prior chemotherapy within 5 years of the diagnosis of SCLC.

 Presence of either measurable or non-measurable SCLC by X-ray or physical examination.

 At least 3 weeks since last major surgery (a lesser period is acceptable if decided to be in the best interest of the patient).

 At least 24 hours since prior radiotherapy. Patients who have received radiotherapy must have recovered from any reversible side effects, such as nausea and vomiting.

 Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.

Exclusion criteria: :

 Symptoms of spreading of the disease to the brain that requires treatment with drugs called steroids.

 Any active infection.

 Severe medical problems other than the diagnosis of SCLC, that would limit the ability of the patient to follow study guidelines or that would expose the patient to extreme risk.

 Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of SCLC.

 Use of an investigational drug within 30 days before the first dose of study medication.

 Women who are pregnant or lactating.

 Patients of child-bearing potential who refuse to practice an adequate form of birth control.

 Patients with clinical evidence of any stomach or intestinal (GI) condition.

 Patients requiring treatment with the drug cyclosporin A.


Apixaban Pharmacokinetics in Bariatric Patients (APB)

Summary: The Center for Bariatric Surgery is interested in conducting a pharmacokinetic study of apixaban (an oral anticoagulant with FDA approval for use of venous thrombo embolism (VTE) prophylaxis and treatment) in the obese adult population to determine if bariatric surgery influences apixaban exposure. More interesting would be to see how the dose may need to change pre- vs. post-bariatric surgery (this will be important for physicians as more and more patients undergo this procedure worldwide and many may require anticoagulation in their future healthcare).~Physicians and surgeons are very interested in oral anticoagulants for this special patient population. To date, there is no approved dosing for the obese patient (especially when considering surgical intervention such as bariatric surgery).~Primary outcome variable.~To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index (BMI) of 35 kg/m2 or greater following one of two bariatric surgical procedures (pre-operative versus post-operative vertical sleeve gastrectomy or Roux-en-Y gastric bypass patients).~Secondary outcome variables.~To compare/contrast the pharmacokinetics and pharmacodynamics of apixaban in bariatric surgical patients who have undergone RYGB vs. VSG.~To determine how the pharmacokinetics of the drug may differ when there is significant post-operative surgical weight loss (>40% estimated excess body weight) 12 to 18 months following surgery versus those patients who have suboptimal weight loss following bariatric surgery (< 40% of estimated excess body weight).
Inclusion criteria: inclusion criteria:

 Men or women, 18 to 65 years old with a BMI of 35 kg/m2 or greater who will be undergoing bariatric surgery (VSG and RYGB)

 Signed written informed consent

 Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug

 Women must not be breastfeeding

Exclusion criteria: :

 History of documented clotting/coagulation disorder

 History of cancer (within the last year)

 Any diagnosis requiring anti-coagulation

 History of hypersensitivity reaction to apixaban

 Active clinically significant bleeding

 Creatinine > 1.5 mg/dL

 Participants currently receiving any type of anticoagulation or blood thinning medications, including heparin, low molecular weight heparins, Plavix, aspirin, NSAIDS

 Participant who is taking any of the excluded medications

 Combined P-glycoprotein and strong cytochrome P450 (CYP) 3A4 inhibitor

 Combined P-glycoprotein and moderate CYP 3A4 inhibitor

 Combined P-glycoprotein inducer and strong CYP 3A4 inducer

 Inducers of p-glycoprotein

 Strong inducers of CYP 3A4


Laparoscopic Occlusion of Uterine Vessels Compared to Uterine Fibroid Embolization for Treatment of Uterine Fibroids

Summary: Women with symptomatic uterine fibroids are treated either by Uterine Fibroid Embolization (UFE) or laparoscopic occlusion. The study hypothesis is that laparoscopic occlusion of uterine vessels and UFE have equal effect on bleeding symptoms. Menstrual bleeding reduction six months after treatment is the main endpoint. Secondary endpoints include participants assessment of symptom relief, and volume reduction of fibroids measured by MRI. We will also investigate possible differences in postoperative course, symptom reduction, complication, and recurrence. Patients are controlled with regular intervals up to five years after treatment.
Inclusion criteria: inclusion criteria:

 Menorrhagia and/or bulk symptoms associated with uterine fibroids

Exclusion criteria: :

 Malignancy

 Current or planned pregnancy

 Small submucous fibroids suitable for hysteroscopic resection

 Postmenopausal women

 Suspected or known adenomyosis

 Uterus size exceeding the umbilical level

 Contraindications against laparoscopic surgery

['Laparoscopic bilateral occlusion of uterine artery', 'Radiological embolization (UFE)']


Study of Varenicline (Champix) for Smoking Cessation/Reduction in Patients With Bipolar Disorder

Summary: Bipolar Disorder is a chronic relapsing mental disorder characterized by periods of elevated, expansive and irritable mood, often alternating with periods of significant clinical depression. People with Bipolar Disorder are typically heavy smokers who have difficulty quitting, and this is associated with significant tobacco-related medical illness and death.~The proposed study will be a double-blind, placebo-controlled 10-week clinical trial of the safety and efficacy of varenicline (Champix™) in thirty subjects with Bipolar I Disorder. This medication is the latest first-line pharmacotherapy for smoking cessation and has been shown to be efficacious for smoking cessation, but has not yet been systematically studied in persons with Bipolar Disorder.
Inclusion criteria: inclusion criteria:

 Structured Clinical Interview (SCID) derived DSM-IV diagnoses of Bipolar Disorder (Type I or II), and Nicotine Dependence

 Young Mania Rating Scale Total Score <12 at study entry

 HAM-D 17-Item Score >5 and <24 at study entry

 Fagerstrom Test for Nicotine Dependence (FTND) score of 5 or higher

 Be able to provide informed consent to participate in this study as judged by clinical evaluation, and scoring at least 80% on a post-consent test

 Smoking at least 10 cigarettes per day (confirmed by an expired breath CO level >10 ppm and a plasma cotinine level >150 ng/ml at baseline)

 Be motivated to quit smoking within 30 days of initial evaluation, as assessed by a score of 7 or higher on the Contemplation Ladder assessment tool

 On a stable dose of a mood stabilizer for at least 1 month (e.g. lithium, valproate, carbamazepine, atypical antipsychotic)

 Judged by the study psychiatrists and/or trained psychiatric clinicians to be in remission from active manic, hypomanic, major depressive and psychotic symptoms based on a clinical interview and SCID-IV ≥1 month prior to study enrollment

Exclusion criteria: :

 Meet criteria for current abuse or dependence for any other alcohol or illicit substance within the past 3 months of study enrollment

 Current evidence by SCID-IV and clinical evaluation of suicidality, homicidality or psychosis

 Meet DSM-IV criteria for current major depression at the time of baseline evaluation

 A history of hypersensitivity or other known adverse reactions (e.g. hyperstimulation, severe agitation) to varenicline.

 Serious medical conditions (i.e. a history of severe cardiac, renal or hepatic disease, diabetes mellitus or thyroid abnormalities)

 EKG abnormalities

 Prescription of Nicotine Replacement Therapies (NRTs) including patches, gum, lozenges or inhalers

 Prescription of monoamine oxidase inhibitors (MAO-I's) including selegiline or moclobemide

 Prescription of varenicline

 Prescription of bupropion SR

 The presence of manic, mixed manic or hypomanic symptoms in the past one month prior to study enrollment.

 A lifetime history of antidepressant-induced mania or hypomania

 A history of suicidal ideation while taking antidepressants


Identifying Genes That Predict Recurrence in Women With Breast Cancer Treated With Chemotherapy

Summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict whether cancer will come back after treatment.~PURPOSE: This laboratory study is identifying genes that may help predict recurrence in women with breast cancer treated with chemotherapy.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Diagnosis of breast cancer

 Node positive OR high-risk node negative disease

 Tumor > 1.0 cm in diameter

 No locally advanced, inflammatory, or metastatic breast cancer

 Previously treated with 4 courses of anthracycline-containing chemotherapy (i.e., doxorubicin and docetaxel OR doxorubicin and cyclophosphamide)

 Enrolled on clinical trial ECOG-E2197

 Adequate tumor material available in ECOG Pathology Coordination Center

 Previously consented to future cancer-related research

 Hormone receptor status known

 PATIENT CHARACTERISTICS:

 Female

 Menopausal status not specified

 PRIOR CONCURRENT THERAPY:

 See Disease Characteristics
Exclusion criteria:

['microarray analysis', 'protein expression analysis', 'immunohistochemistry staining method', 'laboratory biomarker analysis']

microarray analysis
protein expression analysis
immunohistochemistry staining method
laboratory biomarker analysis

['Breast Cancer', 'Estrogen Receptor', 'Her-2', 'Pgr']

Breast Cancer
Estrogen Receptor
Her-2
Pgr


Amyloïd Load in Elderly Population: Effect of Cognitive Reserve

Summary: This research aim to explore relationships between the presence of amyloid burden and cognitive performance, and its modulation by educational level. For this purpose we will combine Positron emission tomography (PET) imaging and neuropsychological assessment acquired on 3 groups of subjects, from two population-based cohorts 3C and AMIMage The first group includes cognitively intact participants who will serve as controls, the second group, subjects with mild cognitive impairments without memory complaint and the third, subjects with both mild cognitive impairments and memory complaint.
Inclusion criteria: inclusion criteria:

 Participation in the AMI or 3C cohorts Group 1- Controls

 MMSE > 24 or > 26 for low and high levels of education, respectively.

 Without memory impairment (for episodic memory) on the Free and Cued Selective Reminding Test RL/RI-16 items (FCSRT), free recall > 22 and total recall >42, according to the thresholds for population-based studies

 Without memory complaint

 Without dementia Group 2- Cognitively-impaired subjects without dementia and without memory complaints

 Mini Mental State Evaluation (MMSE) < 24 or < 26 for low and high levels of education, respectively

 With memory impairments according to the RL/RI-16 test (free recall≤22 and/or total recall ≤42), according to the thresholds for population-based studies defined by Auriacombe et al., 2010.

 Without memory complaint

 Without dementia Group 3- Cognitively-impaired subjects without dementia and with memory complaints

 MMSE < 24 or < 26 for low and high levels of education, respectively

 With memory impairments according to the RL/RI-16 test (same thresholds as above)

 With memory complaint

 Without dementia

Exclusion criteria: :

 Being left handed

 Presence of dementia (based on the clinical diagnosis)

 Presence of stroke

 Presence of Parkinson's disease

 Presence of a counter-indication for MRI

 Presence of a counter-indication for PET Scan with [18F]-Flutemetamol

 Presence of any health problem preventing travel to the imaging service of the University Hospital

 Being under the legal guardianship of another person or being unable to provide consent to participate

 Pregnant or breastfeeding woman

['PET', 'MRI', 'neuropsychological tests']

['Plaque, Amyloid', 'Cognitive Deficits']


TempTouch IR Thermometry & Diabetic Patient Self-Care

Summary: Foot ulcers develop in diabetics with neuropathy because of cumulative injury over the course of several days. These patients do not feel pain, and do not recognize their foot is being injured until a wound develops. Areas about to ulcerate become inflamed and hot spots can be identified. This study's purpose is to evaluate the effectiveness of a home infrared temperature probe designed to forewarn patients that an area on the foot is inflamed so they can take preventive measures. The study will evaluate the incidence of diabetic foot ulcers among high-risk patients, evaluate the cost of home temperature monitoring compared to standard therapy, and evaluate patient satisfaction. 180 diabetics at high-risk of having foot complications will be randomized into 3 treatment arms: 1) standard therapy consisting of regular foot care; 2) standard therapy plus recording of a structured foot evaluation using a hand mirror; and 3) standard therapy plus infrared home temperature assessment to identify hot spots. Device patients will measure temperatures at 6 sites on the foot each day. When temperatures are elevated >4°F patients will contact the research nurse and decrease activity. The primary study outcome will be incident foot ulcers and Charcot fractures.
Inclusion criteria: inclusion criteria:

 diagnosis of diabetes by WHO criteria

 ability to provide informed consent

 18-80 years of age

Exclusion criteria: :

 patients with open ulcers or open amputation sites

 active Charcot arthropathy

 severe peripheral vascular disease

 active foot infection

 dementia -impaired cognitive function-

 history of drug or alcohol abuse within one year of the study

 other conditions based on the PI's clinical judgment

['Diabetic Polyneuropathy', 'Diabetic Foot Ulcer', 'Diabetes', 'Foot Infection']

Diabetic Polyneuropathy
Diabetic Foot Ulcer
Diabetes
Foot Infection


Efficacy and Safety of Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries

Summary: This is a randomized, placebo-controlled, double-blinded trial. Forty patients will be randomized into two groups. The subjects in the Treatment Group will be administered with lithium carbonate, while the Control Group will receive placebo.~Each subject will receive oral lithium carbonate or placebo for six weeks. In the treatment group, the dose will be adjusted according to the serum lithium level while in the control group there will be a sham adjustment.~The outcomes will be assessed 6 weeks and 6 months after the onset of the medication. The outcomes will be compared with baseline pre-treatment data to obtain neurological change scores. The efficacy and safety will be analyzed comparing the results of the treatment group with those of the control group.
Inclusion criteria: inclusion criteria:

 Subjects of either gender and 18-60 years of age;

 Subjects with chromic spinal cord injury (defined as a history of spinal cord injury for 12 months or longer);

 Subjects with ASIA - classification of A, B, or C for at least 6 months unchanged;

 Spinal cord injury vertebral level should be between C4 and T10;

 Subjects must be able to read, understand, and complete the VAS;

 Subjects who have voluntarily signed and dated an informed consent form, approved by an IRB/IEC, prior to any study specific procedures.

Exclusion criteria: :

 A history of hypersensitivity or other adverse reaction to lithium;

 Significant renal, cardiovascular, hepatic and psychiatric disease;

 Significant medical diseases or infection;

 Addison's disease;

 Debilitation or dehydration;

 Recently taken or are taking diuretics or other drugs with known interaction with lithium, such as tricyclic antidepressants, NSAIDs and tetracyclines;

 A history of alcohol abuse or drug abuse;

 Pregnant or lactating women;

 Female of childbearing potential and are unwilling to use an effective contraceptive method while enrolled in the study;

 Subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening of this study;

 Subjects who have taken lithium for manic depression or other psychiatric conditions,and finally;

 Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.


Attentional Bias Modification in Patients With Posttraumatic Stress Disorder

Summary: Randomized, placebo-controlled trial of 9 sessions of computerized attentional bias training on attentional bias and on symptoms of Posttraumatic Stress Disorder.
Inclusion criteria: inclusion criteria:

 Diagnosis of Posttraumatic Stress Disorder

Exclusion criteria: :

 Diagnosis of psychosis, drug- or alcohol dependency/abuse;

 Unable to fill in questionnaires in Dutch;

 Color blindness (Stroop test).


K-RAS Oncogene Mutation in Patients With Advanced Non-Small Cell Lung Cancer Associated With Exposure to Wood Smoke and Tobacco Smoking: Therapeutic Implications

Summary: Summary:~Non-small cell lung cancer (NSCLC) is the leading cause of cancer-related death in the world. This neoplasia has a poor survival prognosis due to the low effectiveness of existing treatments. The low effectiveness is associated with the development of an intrinsic and acquired resistance of tumors, which clinically shows through early progression and transitory responses. Tobacco smoking is the major risk factor for NSCLC; however, wood smoke has been described as a strong carcinogen and a relevant risk factor for the development of NSCLC. Current data indicates that lung tumors associated with tobacco smoking and wood smoke show different clinical characteristics, which suggests that they might also have different genetic alterations, which are a consequence of tumor etiology. The description of the frequency and the type of mutations associated with different etiologies of NSCLC could represent the starting point for benefiting each patient according to their specific characteristics. One of the most researched signaling pathways related to cancer cell proliferation is the one activated by the K-RAS oncogene. Active K-RAS mutations have been detected in different types of neoplasia and more than 90% of these mutations occur at codon 12 of the oncogene. These mutations seem to be an independent risk factor for the prognosis of malignant tumors and they are associated with the lack of response to erlotinib, which is a tyrosine-kinase inhibitor. The investigators' research team has recently reported that wood smoke is an independent factor for survival and response to the erlotinib treatment, which suggests that this carcinogen could have a different frequency and pattern of mutations in the K-RAS oncogene, compared to what has been reported in smoking patients. Determining the tumor mutations within the K-RAS oncogene can help improve the response prognosis of patients with advanced NSCLC who have a background of exposure to different factors associated with the appearance of this neoplasia, such as wood smoke exposure or tobacco smoking. Therefore, the objective of this research is to determine the frequency and the type of mutations at codon 12 of the K-RAS oncogene in patients with NSCLC who have a background of exposure to tobacco smoking or wood smoke.
Inclusion criteria: inclusion criteria:

 Patients diagnosed with advanced NSCLC stage IIIB/IV who have not received previous chemotherapy

 Radiotherapy or both and who have tumor tissue embedded in paraffin blocks or formalin-fixed

 These patients must sign an informed consent letter.

Exclusion criteria: :

 Patients who refuse to participate in the study or those who decide to withdraw from it.

 Patients without tumor tissue or with a poor quality sample.


Does Moderate Intensity Exercise Help Prevent Smoking Relapse Among Women?

Summary: This study compares the effects of a standard smoking cessation treatment, including one-time brief counseling and provision of nicotine patch plus an 8-week moderate intensity exercise program versus the same standard smoking cessation treatment plus equivalent contact control among 60 healthy women. We hypothesize that participants in the smoking cessation plus moderate intensity exercise condition will be more likely to quit smoking than participants in the smoking cessation treament plus contact control condition.
Inclusion criteria: inclusion criteria:

 Healthy sedentary smokers (> 4 per day for at least one year)

 Ages 18 to 65 years

 Must be able to give informed consent

 Must live in the area for the next 3 months

 Willing to use the nicotine patch to attempt smoking cessation

 Must receive consent to participate from primary care physician

Exclusion criteria: :

 Cannot read or write fluently in the English language

 Pregnancy or plans to attempt pregnancy

 60 minutes or more per week of moderate or vigorous physical activity

 Smokes cigars, pipes, or uses smokeless tobacco at least once per week

 Currently in a quit smoking program

 Currently using NRT of any kind or using any other quit smoking method or treatment

 Never had an adverse reaction to the nicotine patch resulting in discontinuation of use

 Poor willingness or inability to comply with protocol requirements

 An employee of the Centers for Behavioral and Preventive Medicine

 Previous participant in Commit to Quit or Fit to Quit smoking cessation studies

 Another member of the household is or has been enrolled in this study

 Currently taking a medication that might impact heart rate response, including but not limited to:

 Acebutolol Atenolol Carvedilol Metoprolol Nadolol Pindolol Propranolol Timolol

 Medical problems:

 Cardiac disease of any kind such as angina, a history of myocardial infarction or valve disease including mitral valve prolapse. Anyone with an interventional procedure such as a stent

 Pain, discomfort (or other anginal equivalent) in the chest, neck, jaw, arms or other areas that may be due to ischemia

 Cerebrovasular disease such as stroke or history of transient ischemic attacks

 Peripheral vascular disease (such as claudication)

 Diabetes (both Type I and II)

 Chronic infectious disease (HIV, hepatitis) (hepatitis A is okay)

 Liver disease

 Cystic fibrosis (CF)

 Chronic obstructive pulmonary disease (COPD) (see asthma and bronchitis under questionable)

 Interstitial lung disease

 Emphysema

 Chronic Bronchitis

 Orthopnea (difficulty breathing except in the upright position) or paroxysmal nocturnal dyspnea (sudden shortness of breath at night typically triggered by lying down)

 Current diagnosis of Chronic Fatigue Syndrome

 Current diagnosis of Fibromyalgia

 Abnormal exercise stress test

 Hypertension (anyone currently being followed and/or treated for hypertension)

 Cancer treatment (other than skin cancer) within the past 6 months

 Musculoskeletal problems such as osteoarthritis, gout, osteoporosis or back, hip or knee pain that can interfere with physical activity (i.e., walking at a brisk pace - about 3-mph)

 Any other serious medical condition that might make exercise unsafe or unwise

 Psychiatric Problems

 Hospitalization for a psychiatric disorder in the last 6 months

 Currently suicidal or psychotic, (or suicidal/psychotic in last 6 months)

 Self-report of more than three alcoholic drinks per day on 5 or more days; 5 or more alcoholic drinks on 3 or more days

 Taking these specific medications for psychiatric problems: Mood stabilizer (Lithium, Depakote, Neurontin), Antipsychotics (Haldol, Clozaril, Risperdal)

 Must be on other current psychiatric medications for at least three months

 REQUIRES MD CONSENT FOR THE SPECIFIC CONDITION

 Lightheadedness, dizziness, vertigo, or fainting

 Last electrocardiogram (EKG) performed was abnormal

 Anemia

 Previous ETT for medical reason with normal results

 Irregular heart beats or palpitations in the past two years

 Heart murmurs in the past two years - the person will need physician's consent and an echocardiogram showing no evidence of significant heart disease

['Smoking cessation treatment plus moderate intensity exercise', 'Smoking cessation treatment plus health education']

['Lung Cancer', 'Heart Disease', 'COPD']


Triathlon® Posteriorly Stabilized (PS) Total Knee System - Outcomes Study

Summary: The purpose of this study is to evaluate the clinical outcomes (range of motion, pain, function, radiographic stability, and health related quality of life) of patients receiving the Triathlon® Posterior Stabilized (PS) Total Knee System. These outcomes will be evaluated using pre-operative scores and comparing them to post-operative scores in addition to being compared with cases who received the Scorpio® PS implant.
Inclusion criteria: inclusion criteria:

 The subject is a male or non-pregnant female 21-80 years of age at the time of enrollment.

 The subject requires a primary cemented total knee replacement.

 The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).

 The subject has intact collateral ligaments.

 The subject has signed the IRB approved, study specific Informed Patient Consent Form.

 The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion criteria: :

 The subject has inflammatory arthritis.

 The subject is morbidly obese, BMI > 40.

 The subject has a history of total or unicompartmental reconstruction of the affected joint.

 The subject has had a high tibial osteotomy or femoral osteotomy.

 The subject has a neuromuscular or neurosensory deficiency that would limit the ability to assess the performance of the device.

 The subject has a systemic or metabolic disorder leading to progressive bone deterioration.

 The subject is immunologically suppressed, or receiving chronic steroids (>30 days duration).

 The subject's bone stock is compromised by disease or infection and cannot provide adequate support and/or fixation to the prosthesis.

 The subject has had a knee fusion at the affected joint.

 The subject has an active or suspected latent infection in or about the knee joint.

 The subject is a prisoner.


Effects of Bronchodilators in Mild Chronic Obstructive Pulmonary Disease (COPD)

Summary: In people with mild COPD, the ability to exhale air from the lungs is partly limited because of narrowing and collapse of the airways. This results in the trapping of air within the lungs and over-distention of the lungs and chest (lung hyperinflation).~Breathing at high lung volumes (hyperinflation) is an important cause of breathing discomfort (dyspnea) in people with COPD. Bronchodilators help to relax muscles in the airways or breathing tubes. Bronchodilators are often prescribed if a cough occurs with airway narrowing as this medication can reduce coughing, wheezing and shortness of breath. Bronchodilators can be taken orally, through injection or through inhalation and begin to act almost immediately but with the effect only lasting 4-6 hours. The main purpose of this study is to examine the effects of inhaled bronchodilators on breathing discomfort and exercise endurance in patients with mild COPD.
Inclusion criteria: inclusion criteria:

 diagnosis of mild COPD OR healthy control subjects

 40-80 years old

 able to perform all study procedures

 Smoking history > 10 pack years (for mild COPD) or smoking history < 10 pack years (for healthy control subjects)

Exclusion criteria: :

 allergy to atrovent

 history of asthma, atopy or nasal polyps

 Oxygen desaturation < 80 % during exercise

 recent history of CAD (under a year) or any significant diseases that could contribute to dyspnea or exercise limitation

['Chronic Obstructive Pulmonary Disease (COPD)']


Air Cleaners for Children and Adolescents With Asthma and Dog Allergy

Summary: The purpose is to find out if Icleen IQAir, HEPA-filter air cleaners with high capacity and pre-set speed functions, have a beneficial effect on patients with asthma and allergy to dogs.~Air cleaners will be installed in the bedrooms and living rooms in the homes of children and adolescents aged 8-17 years at the study entry, with allergy to dogs, but not to house dust mites.~The investigators will look upon the significance of this study, and of a previous study with a similar design and the same main parameters to find out if this trial supports the results of the first trial by the same project leader, or makes it likely that the seemingly beneficial effects of the first study occurred by chance.~Main parameters:~hyperventilation cold air challenge test~Supportive parameters:~serum ECP~symptom scores~The trial will be a parallel, double blind placebo controlled one.
Inclusion criteria: inclusion criteria:

 Children and adolescents between 8 and 17 years of age at the start of the trial (born after 01 March '88, but before 01 September '97).

 Bronchial asthma, diagnosed by a physician, and confirmed by a physician at a paediatric department of a Norwegian Hospital.

 Allergy against dogs, confirmed by skin prick test. Average infiltrate at least 4 millimetres against dog, diagnosed by a new skin prick test at entry. For details about skin prick test, see attachment no. 6.

 Having had nose or breathing symptoms by contact with dogs, when no drugs against asthma or allergy have been taken.

 Able to co-operate at cold air hyperventilation test and spirometry (see attachment no. 2).

 Given written consent (by parents of children below 12; by parents and child when above 12, but below 16; by patient when above 16).

Exclusion criteria: :

 Positive house dust mite skin prick test, with a more than 3 mm infiltrate.

 Having taken oral beta-2-agonists or theophylline preparations for the last 2 weeks before trial start, or oral steroids for the last 3 months before start of the trial.

 Active smoking.

 Dogs or cats in the home.

 Staying away from the home continuously for more than 14 days in the trial period or during the last month before trial start.

 Being an in-patient in a special department or institution for asthma and allergy in the trial period or the last 3 months before the trial.

 Having another chronic disease that can influence the results of ECP or cold air hyperreactivity tests.

 Other types of mechanical ventilation or air filtration systems in the homes, except for those for kitchen stoves.


Trial Evaluating Chemoprophylaxis Against Travelers' Diarrhea - Prevent TD

Summary: The purpose of this study is to develop evidence on the relative efficacy of 2 rifaximin chemoprophylaxis regimens for the prevention of Travelers' Diarrhea (TD) in a deployed setting. An additional purpose is to explore the effect of chemoprophylaxis on microbial flora and antimicrobial resistance, and obtain parameter estimates to inform a cost-effectiveness model of chemoprophylaxis in prevention of TD. Information from this study will be used to develop management guidelines for the prevention of TD among deployed (United States (US) and United Kingdom (UK) military personnel.~The study will be a multi-site, randomized, placebo-controlled, double-blind, clinical trial among deployed military personnel. The study will test 2 TD chemoprophylaxis regimens (once daily versus twice daily) of the same antibiotic, rifaximin, compared to a placebo.~For the proposed chemoprophylaxis study described herein, cohorts of military personnel (US and UK) deploying/traveling overseas will be recruited prior to travel to participate and will undergo enrollment procedures as outlined in study appendices. Subjects who are eligible and agree to participate will be randomized to receive one of 3 regimens: (1) rifaximin 550 mg daily; (2) rifaximin 550 mg twice a day; or (3) placebo, to be taken while deployed. Chemoprophylaxis will be maintained for duration of travel or a predetermined period of up to 6 weeks and at least 2 weeks, which may include a period of up to 5 days of use after return to COO for deployments less than 6 weeks in duration. Clinical and laboratory data will be obtained before, during if available and after deployment/chemoprophylaxis.
Inclusion criteria: inclusion criteria:

 An Institutional Review Board (IRB) / Ethics Committee (EC)-approved informed consent form is signed and dated.

 Subject is at least 18 years of age

 Subject's duration of prophylaxis will be least 2 weeks.

 Subject is capable of and willing to comply with all study procedures and available for the end of study visits and sample collection at COO (within 6 months from start of prophylaxis).

 Women: Non-nursing and negative urine/serum pregnancy test with understanding (through informed consent process) to avoid pregnancy while on study drug. Sole reliance on oral contraceptives (OCPs) for birth control will not be recommended (see section 6.3.2.1.) Should an individual have a documented surgical sterilization in her medical record, a pregnancy test will not be required. If a volunteer becomes pregnant during the study, the principal investigator will notify the study research monitor and the IRBs. The pregnancy outcome will be followed per IRB and other regulatory requirements for US and UK personnel.

 (For US Personnel Only). Have consented to participate in TravMil protocol.

Exclusion criteria: :

 Subject received any systemic or gastrointestinal antibiotic in the 7 days prior to enrollment (except anti-malarial prophylaxis agents).

 Subject has hypersensitivity or allergy to rifaximin or rifampicin.

 Subject has acute diarrhea within 7 days prior to enrollment

 Subject has a concomitant disease or condition that could interfere with, or for which treatment could interfere with, the conduct of the study, or could in the opinion of the investigator increase the risk of AEs during the subject's participation in the study

 Subject is currently taking or plans to take during deployment at least one of the following medications: theophylline or warfarin (Coumadin).

["Travelers' Diarrhea", 'Functional Bowel Disorders', 'Reactive Arthritis']

Travelers' Diarrhea
Functional Bowel Disorders
Reactive Arthritis


Prevention of Weight Gain

Summary: The purpose of this study is to test methods for preventing weight gain in normal-weight and overweight women aged 25 through 44. Participants will complete brief questionnaires about their health, eating and exercise habits, and use of weight control strategies. They will then be randomly assigned to 1 of 3 treatment conditions. All 3 treatments receive information on the importance of maintaining a healthy body weight, the components of a healthy diet, and ways to increase activity levels. The 3 treatment differ in how this information is delivered. At 12, 24 and 36 months after enrolling in the study, participants will attend assessment sessions. They will complete questionnaires and have body weight measured.
Inclusion criteria: inclusion criteria:

 Body mass index of 21 through 30

Exclusion criteria: :

 Presence of chronic disease that precludes regular physical activity or changes in dietary intake

 Currently receiving treatment for psychological disorder

 Currently pregnant or having given birth within last 12 months

 Use in last 3 months of weight loss medications or other drugs that affect body weight

 Participation in a weight loss program in last 12 months

 Planning to relocate outside the study area in the next 3 years

['Weight Gain Prevention for Women Project']


Tailored Treatment of Permanent Atrial Fibrillation

Summary: The purpose of this trial is to evaluate the safety and efficacy of the Medtronic Cardiac Ablation System compared to medical therapy in the persistent and long-standing persistent atrial fibrillation population.
Inclusion criteria: inclusion criteria:

 History of symptomatic, continuous atrial fibrillation defined as: Continuous atrial fibrillation lasting greater than 1 year but less than 4 years or nonself-terminating atrial fibrillation, lasting greater than 7 days but no more than 1 year, with at least one failed direct current cardioversion. A failed cardioversion was defined as an unsuccessful cardioversion or one in which normal sinus rhythm was established but not maintained beyond 7 days.

 Atrial fibrillation symptoms included the following: palpitations, fatigue,exertional dyspnea, exercise intolerance

 Age between 18 and 70 years

 Failure of at least one Class I or III rhythm control drug

 Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study.

Exclusion criteria: :

 Structural heart disease of clinical significance including:

 Previous cardiac surgery (excluding coronary artery bypass graft and mitral valve repair)

 Symptoms of congestive heart failure including, but not limited to, New York Heart Association (NYHA) Class III or IV congestive heart failure and/or documented ejection fraction <40% measured by acceptable cardiac testing

 Left atrial diameter >55 mm

 Moderate to severe mitral or aortic valvular heart disease

 Stable/unstable angina or ongoing myocardial ischemia

 Myocardial infarction (MI) within 3 months of enrollment

 Congenital heart disease (not including atrial septal defect or patent foramen ovale without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure

 Prior atrial septal defect of patent foramen ovale closure with a device using a percutaneous approach

 Hypertrophic cardiomyopathy (left ventricular septal wall thickness >1.5 cm)

 Pulmonary hypertension (mean or systolic pulmonary artery pressure >50 mm Hg on Doppler echo)

 Any prior ablation for atrial fibrillation

 Enrollment in any other ongoing arrhythmia study

 Any ventricular tachyarrhythmia currently being treated where the arrhythmia or the management may interfere with this study

 Active infection or sepsis

 Any history of cerebral vascular disease including stroke or transient ischemic attacks

 Pregnancy or lactation

 Left atrial thrombus at the time of ablation

 Untreatable allergy to contrast media

 Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes

 History of blood clotting (bleeding or thrombotic) abnormalities

 Known sensitivities to heparin or warfarin

 Severe chronic obstructive pulmonary disease (defined as forced expiratory volume 1 (FEV1) <1)

 Severe co-morbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate

['Medtronic Cardiac Ablation System', 'Class I or III Antiarrhythmic Medications']


Study of the Prognostic Value of Musculoskeletal Ultrasound in Adults With Chikungunya

Summary: Chikungunya is a viral disease transmitted by mosquitoes whose clinical feature is the early joint damage. Approximately 8% of patients have chronic arthropathy resembling to the rheumatoid polyarthritis. The EchoCHIK study we propose is in the context of the epidemic in Martinique which began in January 2014. It should give a better understanding of arthritis and juxtaarticular of CHIK and look for signs that may allow ultrasound predict the evolution of chronic arthropathy of CHIK.
Inclusion criteria: inclusion criteria:

 Age at onset of symptoms ≥ 45 years

 Seen in consultation at the University Hospital of Fort-de-France

 Suspected chikungunya infection (fever and sudden onset of joint pain affecting the wrists, hands, ankles or knees)

 Duration of symptoms suggestive of infection chikungunya less than or equal to 10 days

 Presence of joint pain on the day of inclusion

 No history of inflammatory arthritis

 Absence of steroidal or non-steroidal anti-inflammatory drugs taken within two weeks prior to inclusion

 Ability to participate in the study throughout its duration (12 months)

 Patient affiliated or beneficiary of a social health care.

 Acceptance to participate in the study and monitoring proposed and signed informed consent

Exclusion criteria: :

 Age at onset of symptoms <45 years

 Duration of symptoms suggestive of chikungunya for more than 10 days

 Lack of joint pain on the day of inclusion

 History of inflammatory arthritis Nonsteroidal anti-inflammatory drugs or

 Taking in the two weeks preceding the inclusion

 Inability to participate in the study throughout its duration (12 months)

 Patient is not affiliated or beneficiary of a social health care.

 Refusal to participate in the study or to sign a consent


Effects of Targeting Lower Arterial Oxygen Saturations on the Development of Control of Breathing in Very Preterm Infants

Summary: To determine whether targeting lower arterial oxygen saturations from the day of birth alters the early (first 3 months) postnatal development of the control of ventilation and the hypercapnic and hyperoxic responses in very preterm infants.
Inclusion criteria: inclusion criteria:

 Gestational age 23 0/7 - 27 6/7 weeks

 Enrolled in the COT trial at the Health Sciences Centre and the St. Boniface General Hospital in Winnipeg

 Postnatal age between 21 days and 70 days

 Informed written consent obtained from at least one of the parents.

Exclusion criteria: :

 Need for mechanical ventilation, NCPAP or O2

 Sepsis or other known causes of apnea.

['Oxygen saturation range', 'Oxygen saturation range']

Oxygen saturation range
Oxygen saturation range


Impact of Hyperarousal on Simple and Complex Cognitive Task Performance Among Insomnia Sufferers

Summary: The purpose of this study is to learn more about people with insomnia disorder and cognitive impairment. Cognitive impairment is difficulty with mental abilities such as thinking, knowing and remembering.
Inclusion criteria: inclusion criteria:

 21 to 80 years of age

 Insomnia sufferers enrolled, will meet Research Diagnostic Criteria for insomnia disorder

 score > 14 on the Insomnia Severity Index

 report insomnia for > 3 months

 have sleep difficulties > 3 nights per week

 score < 3 on the Epworth Sleepiness Scale (ESS)

 score > 40 on the Hyperarousal Scale and report an inability to nap in the daytime

 The normal sleepers enrolled will report general satisfaction with sleep and no sleep/wake complaints, score < 10 on the ESS, score < 35 on the Hyperarousal Scale, and deny a practice of routine daytime napping

Exclusion criteria: :

 sleep-disruptive medical condition (e.g., rheumatoid arthritis)

 current major psychiatric (Axis I) condition on the basis of a Structured Clinical Interview for Psychiatric Disorders (SCID)

 sedative hypnotic dependence and unwillingness/inability to abstain from these medications while in the study

 use of anxiolytics, antidepressants, or any other psychotropic medication

 an apnea/hypopnea index (AHI) > 5 or a periodic limb movement-related arousal index > 5 during on screening PSG that includes a full sleep montage to allow for detection/diagnosis of sleep-disordered breathing and Periodic Limb Movement Disorder (PLMD).

 female participants who have tested positive on urine pregnancy tests or planing on becoming pregnant during the study

 Additionally, self-described NS who meet criteria for any sleep disorder and those insomnia sufferers who meet criteria for a comorbid sleep disorder in addition to insomnia disorder will also be excluded

['Insomnia', 'Primary Insomnia', 'Chronic Insomnia']

Insomnia
Primary Insomnia
Chronic Insomnia


Surgeon-Patient Communication: A Randomized Controlled Trial Evaluating the Impact of an Orthopaedic Related Smoking Cessation Discussion After Fracture Surgery

Summary: In this study, the investigators are interested in evaluating the impact of an orthopaedic related smoking cessation discussion after fracture surgery.
Inclusion criteria: inclusion criteria:

 Patients 18 year old or older,

 daily smoker

 inpatient post fracture operation,

 patient that have never received an orthopaedic related smoking cessation discussion

Exclusion criteria: :

 Younger than 18,

 patients unable to provide consent

 patients that suffer from auditory/visual/mental disability requiring another individual as a decision-maker


Open-Label Trial of Peripheral Blood Progenitor Cell (PBPC) Mobilization by Filgrastim in Normal Donors

Summary: The purpose of this study is to clinically evaluate the spleen during PBPC mobilization by filgrastim in normal donors.
Inclusion criteria: inclusion criteria: - Eligible to be PBPC donor for allogeneic transplantation as determined by local institution
Exclusion criteria: : - History of splenectomy - Previous PBPC mobilization attempts - Previous treatment with GCSF or GMCSF