The Immunogenicity and Safety of 2012-2013 Trivalent Seasonal Influenza Vaccine

Summary: The purpose of this study is to evaluate the immunogenicity and safety of 2012-2013 trivalent seasonal influenza vaccine in 60 healthy infants aged 6-35 months old, 60 healthy adults aged 18-60 years old, and 60 healthy older people aged > 60 years.
Inclusion criteria: For adults and old people:

 inclusion criteria:

 Healthy adults aged 18-60 years old, and healthy old people aged >60 years

 Be able to show legal identity card for the sake of recruitment Without vaccination history of seasonal split influenza vaccine in the recent 3 years

 Not participate in any other clinical trials during the study

 Not receive any immunosuppressive agents during and one month prior to the study

 Be able to understand and sign the informed consent.

Exclusion criteria: :

 Woman： Who breast-feeding or planning to become pregnant during the study

 Any history of allergic reactions; was allergic to any component of the vaccine, such as eggs or ovalbumin

 Any history of severe adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain

 Autoimmune disease or immunodeficiency

 Acute episode of chronic diseases or conditions, including chronic hepatitis, hypertension, diabetes mellitus and cardiovascular diseases

 Guillain-Barre Syndrome

 Women subjects with positive urinary pregnancy test

 Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)

 Axillary temperature >37.0 centigrade at the time of dosing

 Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment

 Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.

 For infants:

 inclusion criteria:

 Healthy male or female aged between 6 and 35 months

 Full-term birth, birth weight 2,500 grams or more

 provided birth certification or vaccination card Parent(s) or legal guardian(s) are able to understand and sign the informed consent

['2012-2013 trivalent seasonal influenza vaccine']


A Study of the Safety and Efficacy of Infliximab (Remicade) in Pediatric Patients With Crohn's Disease

Summary: A study of the safety and efficacy of infliximab (Remicade) in pediatric patients with moderate to severe Crohn's Disease
Inclusion criteria: inclusion criteria:

 Between the ages of 6 and 17 years

 Have had Crohn's disease diagnosed for at least 3 months prior to screening, with gastritis, duodenitis, colitis, ileitis, or ileocolitis, previously confirmed by endoscopy and biopsy

 Have active Crohn's disease despite adequate current treatment with an immunomodulator (ie, AZA, 6-MP, or MTX).

Exclusion criteria: :

 Disease complications for which surgery might be indicated

 Surgery for bowel diversion with placement of a stoma within 3 months prior to screening

 Positive stool examination for enteric pathogens including Giardia lamblia, Clostridium difficile, Shigella species, and Salmonella species.


Enriched Environments for Upper Limb Stroke Rehabilitation

Summary: Stroke contributes significantly to the incidence of disabilities, with upper limb (UL) motor impairment being especially prevalent. Animal studies suggest that post-stroke motor recovery is largely attributable to adaptive plasticity in brain motor areas. While some environmental training factors contributing to plastic mechanisms have been identified in animals, translation of this knowledge to the clinical setting is insufficient. Optimal recovery may be related to both external (e.g., feedback type) and internal factors (e.g., cognitive ability, motivation). Clinically feasible methods for training are needed. Use of enriched virtual environments (VEs) may provide a way to address these needs. Outcome measures that best reflect recovery need to be identified since this is an essential step to evaluate the effect of novel training programs for UL motor recovery in stroke.~The research question is which clinical and kinematic outcome measures best reflect motor performance recovery after a targeted upper limb treatment intervention. Aim 1 is to compare changes in outcome measures recorded before and after an upper limb intervention in stroke subjects to motor performance in healthy subjects. Aim 2 is to determine motor performance between-group differences sample size is based on knowledge of expected outcome measure mean score differences between groups. Hypothesis. 1: Specific clinical and kinematic outcome measures will be sensitive to within-group (pre-post intervention training) changes. Hypothesis. 2: Specific clinical and kinematic outcome measures will be sensitive to between-group (healthy vs. patients in enriched vs. conventional intervention groups. Sixteen chronic stroke survivors and 8 age- and sex-matched healthy controls will participate. Patients will be matched on cognitive and motor impairment levels and divided into two groups. Using an single subject (A-B-A) research design, kinematics during two pre-tests, 3 weeks apart, will be recorded for test-retest reliability. Stroke groups will practice varied upper limb reaching movements (15 45-minute sessions in 3 weeks) in environments providing different motivation/feedback levels. Pre- and post motor performance evaluations will be done with clinical tests and a Test Task with specific motor performance requirements. A Transfer Task will also be recorded. By comparing data analysis methods (3-Dimensional (3D) analysis of different markers or placements), the investigators will identify which kinematic outcome measures best reflect motor improvement in post-test and follow-up sessions (retention).~The expected results are identification of two primary and two secondary outcome measures that reflect upper limb motor recovery and can distinguish between motor recovery and compensation. The results will be used to design a randomized control trial to determine the efficacy of VE-based treatment on arm motor recovery. The goal is to determine how extrinsic (environmental) and intrinsic (personal) motivational factors affect motor learning in stroke survivors with cognitive and physical impairment. Knowledge gained can also be used for rehabilitation of other neurological and orthopedic pathologies.
Inclusion criteria: inclusion criteria for patients wth stroke:

 Age 40-80 years

 sustained a single stroke between 3-24 months prio t study leading to upper limb paresis

 have at least Stage 3/7 arm control (mild to moderate motor deficits) on the Chedoke-McMaster Scale.

 <81 yrs old to minimize confounding effects of age-related changes in sensorimotor functions

Exclusion criteria:  for patients wth stroke:

 other neurological or orthopaedic problems that may interfere with interpretation of results

 significant deficits in attention, constructional skills, neglect and apraxia

 shoulder subluxation, arm pain

 lack of endurance as judged by a physician

 undergoing other therapy, surgery or medical procedures within the study period.

 inclusion criteria for healthy control subjects:

 1. Age 40-80 years

['conventional occupational therapy', 'video capture virtual reality']

conventional occupational therapy
video capture virtual reality


V/Q SPECT for Diagnosis of Pulmonary Embolism

Summary: The objective of the study was to assess diagnostic performance of V/Q SPECT for the diagnosis of pulmonary embolism by comparing V/Q SPECT results to a validated diagnostic strategy.
Inclusion criteria: inclusion criteria:

 Pulmonary embolism suspicion
Exclusion criteria:


Hatha Yoga Exercises in Pelvic and Lumbar Back Pain in Pregnant Woman

Summary: The aim of this study is to identify evaluate the effectiveness of stretching exercises of Hatha Yoga method in pregnant women with back pain and posterior pelvic City Paulínia. -There will be a randomized clinical trial with 60 pregnant women with these symptoms. They will be randomly divided into 2 groups. The group A will perform the exercises of Hatha Yoga for ten weeks, once a week group B postural follow the guidelines recommended for the treatment of these pains, for ten weeks. Will be used as a technique for evaluating the Visual Analogue Scale to measure pain intensity and confirmation tests of the lumbar and posterior pelvic pain in order to differentiate them. A descriptive statistical analysis of univariate and bivariate distributions will be made through frequency and graphical representation. The association between the variables will be tested by statistical tests: [chi-square (X ²)], Fisher's exact test, Student's t test or Mann-Whitney, [Student's t test to compare means], ANOVA for the analysis of effects between the groups. [The significance level is predetermined to 5%]. The data will be analyzed in EPI-INFO 2000. SAS 9.0 and from the database created .
Inclusion criteria: inclusion criteria:

 Lower back pain and / or posterior pelvic pain when completing the interview. Gestational age greater than or equal to 12 weeks.

Exclusion criteria: :

 Twin pregnancy. Medical restrictions on the exercise. Be doing physical therapy for the symptom of back pain and / or posterior pelvic

['LUMBAR BACK PAIN', 'PELVIC PAIN', 'PREGNANCY']


A Chronic Obstructive Pulmonary Disease (COPD) Trial Investigating Roflumilast on Safety and Effectiveness in China, Hong Kong and Singapore:

Summary: The aim of this trial is to determine the efficacy, safety and tolerability of 500 µg Roflumilast tablets once daily in patients with COPD in China, Hong Kong, and Singapore.
Inclusion criteria: Main inclusion criteria:

 Willingness to sign a written informed consent

 Chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2009

 Chinese or Malay or Indian ethnicity

 History of chronic obstructive pulmonary disease symptoms for at least 12 months prior to baseline visit V0

 Forced expiratory volume in the first second/ Forced vital capacity (FEV1/FVC) ratio (post-bronchodilator) < 70%

 Forced expiratory volume in the first second (FEV1) (post-bronchodilator) < 50 % of predicted

 Former smoker (defined as: smoking cessation at least one year ago) or current smoker both with a smoking history of at least 10 pack years

 Main
Exclusion criteria: :

 Moderate or severe COPD exacerbation and/or COPD exacerbations treated with antibiotics not stopped at V0

 Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit V0

 History of asthma diagnosis in patients < 40 years of age or relevant lung disease other than COPD

 Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding the baseline visit V0

 Known alpha-1-antitrypsin deficiency


Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy

Summary: For post-menopausal women diagnosed with hormone-receptor positive breast cancer tumors, aromatase inhibitors (AIs) are the standard adjuvant hormone treatment to prolong disease-free survival and time-to-recurrence. Unfortunately, joint pain/stiffness/achiness (arthralgia) is a common side-effect of AIs. This proof-of-concept study explores how an evidence-based physical activity (PA) program- the Arthritis Foundation's Walk with Ease (WWE) program- can be adapted for breast cancer survivors on AI therapy to: 1) Help them maintain or achieve recommended levels of PA, 2) reduce their joint pain/stiffness/achiness, and 3) thereby enable them to remain on AI therapy as prescribed.
Inclusion criteria: inclusion criteria:

 Taking an aromatase inhibitor as adjuvant treatment for State I, II, or II breast cancer for at least 4 weeks

 Experiencing more than mild joint pain/symptoms

 21 or older

 have permission from physician to engage in moderate intensity physical activity

Exclusion criteria: :

 Undergoing chemotherapy and/or radiation therapy at any time during the study period

 Scheduled for major surgery during the study period

 Presently engaged in high levels of physical activity on a daily basis

 Less than 21 years of age

 Unable to walk or engage in moderate intensity physical activity


Hairstetics™ Anchoring System in Female Pattern Hair Loss (HAS-FPHL)

Summary: The aim of the study is to provide evidence of safety and preliminary performance of the Hairstetics™ anchoring system in female subjects affected with androgenetic alopecia (female pattern hair loss; (FPHL)).~The study will also help to determine whether the Hairstetics™ anchoring system, in conjunction with attachment of hair extensions, is efficacious in improving patient and physician aesthetic satisfaction with the treated scalp appearance in female patients with androgenetic alopecia.
Inclusion criteria: inclusion criteria:

 Age ≥ 19 yrs.

 Female patients with androgenetic alopecia (FPHL).

 Pre-treatment hematology and coagulation values within the limits:

 Hemoglobin ≥ 10 g/dl (g/100 ml)

 Platelets ≥ 150 x 10^9/L (10^3/mm^3)

 WBC ≥ 3.0 x 10^9/L (10^3/mm^3)

 INR 0.8 - 1.2 ---

 PTT 25 - 35

 Serum creatinine < 2 mg/dl

 SGOT < 1.5 x ULN (Upper Limit of Norm)

 SGPT < 1.5 x ULN

 Alkaline phosphatase < 1.5 x ULN

 A life expectancy at least of the duration of the trial.

 Signed informed consent and post-implantation protocol.

Exclusion criteria: :

 Prosthetic hair implantation or hair transplantation in the 6 months preceding enrollment to this study.

 Skin conditions that might affect the procedure and/or its outcome. NOTE: Such conditions are not necessarily restricted to or involve the prospective implantation site and/or its vicinity.

 Patients currently receiving, or that have received within the past 3 months, radio- and/or chemotherapy.

 Patients on anticoagulant treatment.

 More than a maintenance dose of oral corticosteroids (maintenance dose is defined as the same dose regimen over the past 6 months for a condition requiring continual corticosteroid treatment) or patients with an immunocompromised state for any reason.

 Bleeding disorder.

 Patient presenting with a health condition that may affect compliance with the study protocol, either by itself or combined with other conditions present in the patient.

 Use of illegal substances.

 Participation in another interventional study, unless discussed with and approved by the Sponsor or Sponsor's authorized representative.

 Quantitative β-HCG ≥ 5 mIU/mL (IU/L) in women of childbearing potential.

 Lactating and/or breastfeeding women.

 Known hypersensitivity (e.g., to nitinol, nickel or titanium) or adverse event that would prevent a prospective study participant from being administered the trial treatment or non-investigational medicinal product(s), as detailed in the protocol.

 Patients with implanted electronic devices (such as cardiac pacemakers) unless they receive permission from their treating physician (e.g., cardiologist) and are monitored by a treating physician during the treatment session.

['Female Pattern Baldness', 'Alopecia, Androgenetic']

Female Pattern Baldness
Alopecia
Androgenetic


Bosutinib For Autosomal Dominant Polycystic Kidney Disease

Summary: This purpose of this study is to determine if bosutinib reduces the rate of kidney enlargement in subjects with autosomal dominant polycystic kidney disease (ADPKD) entering the study with a total kidney volume greater than or equal to 750 cc and eGFR greater than or equal to 60 mL/min/1.73m2.
Inclusion criteria: inclusion criteria:

 Males and females, 18 to 50 years old at the time of consent.

 Documented diagnosis of ADPKD (PKD-1 or PKD-2 genotypes allowed).

 Total kidney volume ≥ 750 cc, as measured by centrally evaluated MRI.

Exclusion criteria: :

 eGFR < 60 mL/min/1.73m2.

 Uncontrolled hypertension (defined as systolic blood pressure ≥140 or diastolic blood pressure ≥90 mm Hg).

 Any previous exposure to the bosutinib test article or receipt of other polycystic kidney disease (PKD) therapies.

['Polycystic Kidney, Autosomal Dominant']


Efficacy of Peritonsillar Dexmedetomidine Infiltration for Postadenotonsillectomy Pain

Summary: The purpose of the present study is the clinical assessment of the efficacy of preincisional peritonsillar infiltration of dexmedetomidine on postoperative pain relief in children undergoing adenotonsillectomy.
Inclusion criteria: inclusion criteria:

 children aged 3-9 years American Society of Anesthesiologists 1-2 status, scheduled for adenotonsillectomy

Exclusion criteria: :

 Children with systemic disease, metabolic and endocrin disorders, growth developmental and motor-mental retardation, those who had a history of allergy to any of the study drugs, peritonsillar abscess, hypertension, psychiatric and epileptic disorders, chronic pain syndrome, and those who received analgesics within 24 h prior to surgery were excluded from study.

['Pain Postoperative, Intraoperative Hemorrhage']

Pain Postoperative
Intraoperative Hemorrhage


Framingham State Food Study

Summary: This study will evaluate the effects of dietary composition on energy expenditure and chronic disease risk factors, while also exploring physiological mechanisms underlying these effects.
Inclusion criteria: inclusion criteria:

 Aged 18 to 65 years

 BMI ≥ 25 kg/m2

 Weight ≤ 425 lbs

 Medical clearance from a primary care provider

 Plans to matriculate at Framingham State University (campus-based participants: students), work on campus (campus-based participants: faculty and staff), or live in the greater Framingham area (community-based participants) throughout the academic year of enrollment in the study

 Academic and social clearance from the FSU Office of Enrollment and Student Development (student participants) or willingness to comply with Criminal Offender Record Information (CORI) check and Sex Offender Registry Information (SORI) check (community-based subjects)

 Willingness to eat and drink only the foods and beverages on the study menus during participation, with no food allergies or aversions

 Willingness to eat in the dining hall

 Willingness to abstain from consuming alcohol during participation

Exclusion criteria: :

 Change in body weight exceeding ±10% during prior year

 Recent adherence to a special diet

 Recent adherence to a vigorous physical activity regimen (e.g., participation in a varsity sport)

 Chronic use of any medication or dietary supplement that could affect study outcomes

 Current smoking (1 cigarette in the last week)

 Heavy baseline alcohol consumption (> 10 drinks/week) or history of binge drinking (≥ 5 drinks in 1 day, anytime in past 6 months)

 Physician diagnosis of a major medical/psychiatric illness or eating disorder

 Abnormal HgA1c, TSH, BUN, creatinine; hematocrit < 30; ALT > 200% of normal upper limit

 Plans for a vacation during the study that would preclude adherence to prescribed diet

 Additional exclusions for female participants: Irregular menstrual cycles; any change in birth control medication during the 3 months prior to enrollment; pregnancy or lactation during the 12 months prior to enrollment

['Obesity', 'Diabetes', 'Cardiovascular Disease']


Phase I Study of West Nile Virus Vaccine

Summary: This study will test the safety of an experimental vaccine for preventing West Nile virus infection. The virus is spread mainly by mosquito bites. Symptoms can include high fever, headache, neck stiffness, stupor, muscle weakness, vision loss, numbness and paralysis. Rarely, infection leads to permanent nerve damage and possibly death. The vaccine used in the study is made from DNA that codes for West Nile virus proteins. Injected into a muscle, the DNA instructs the body to make a small amount of West Nile virus protein. This study will see if the body creates resistance or immunity to these proteins. Participants cannot get West Nile virus from the vaccine.~Healthy normal volunteers between 18 and 65 years of age may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests for various infections and other medical problems. Women who are able to become pregnant are given a pregnancy test. Women who are pregnant or breastfeeding may not participate. Anyone who has received a vaccination for Yellow Fever or Japanese Encephalitis virus in the past may not participate in this research study.~Participants will receive three injections of the experimental vaccine, the first on the first study day (Day 0), the second on Day 28, and the third on Day 56. The injections are given with a device called Biojector® (Registered Trademark) 2000 that delivers the vaccine through the skin into the muscle without the use of a needle. On the day of each injection, subjects are given a diary card to take home for recording their temperature and any symptoms or side effects for 5 days. They return to the clinic 2 weeks after each injection, bringing the completed card with them at that time. In addition to the injections, subjects have the following tests and procedures during clinic visits:~Medical history and, if needed, physical examination: Day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32~Vital signs and weight: Day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32~Lymph node exam: Day 0 and weeks 2, 4, 6, 8, 10, and 12~Blood samples: Day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32~Pregnancy test (for women): Day 0 and weeks 4, 8 and 32~Urine sample: Day 0 and weeks 2, 4, 6, 8, and 10~The blood and urine tests are for health checks. Some blood samples are also used to study the immune response to the vaccine and for gene testing.
Inclusion criteria: inclusion criteria:

 A participant must meet all of the following criteria:

 18 to 65 years old.

 Available for clinical follow-up through Week 32 and contact (correspondence, telephone or e-mail) or clinical visit through Week 52 of the study.

 Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.

 Complete an Assessment of Understanding prior to enrollment and verbalize understanding of all questions answered incorrectly.

 Able and willing to complete the informed consent process.

 Willing to receive HIV test results and willing to abide by NIH guidelines for partner notification of positive HIV results.

 Willing to donate blood for sample storage to be used for future research and genetic testing, including HLA analysis.

 In good general health without clinically significant medical history and has satisfactorily completed screening.

 Physical examination and laboratory results without clinically significant findings and a body mass index (BMI) less than 40 within the 28 days prior to enrollment.

 Laboratory Criteria within 28 days prior to enrollment:

 Hemoglobin greater than or equal to 11.5 g/dL for women; greater than or equal to 13.5 g/dL for men.

 White blood cell (WBC) equal to 3,300-12,000 cells/mm(3).

 Absolute neutrophil count (ANC) within institutional normal range.

 Total lymphocyte count greater than or equal to 800 cells/mm(3).

 Platelets equal to 125,000 - 400,000/mm(3).

 Alanine aminotransferase (ALT; SGPT) less than or equal to 1.25 x upper limit of normal.

 Serum creatinine less than or equal to 1 x upper limit of normal (less than or equal to 1.3 mg/dL for females; less than or equal to 1.4 mg/dL for males).

 Normal urinalysis defined as negative glucose, negative or trace protein, and no clinically significant blood in the urine.

 Negative FDA-approved HIV blood test. [Note: Results of HIV ELISA will be documented, but a negative HIV PCR will be sufficient for eligibility screening of subjects with positive HIV ELISA that is due to prior participation in an HIV vaccine study.]

 Negative hepatitis B surface antigen.

 Negative anti-HCV and negative hepatitis C virus (HCV) PCR.

 Laboratory Criteria within 12 weeks (84 days) prior to enrollment:

 Negative flavivirus serology (in the Focus Technologies WNV antibody ELISA assay) within 84 days prior to enrollment and no history of prior vaccination against yellow fever or Japanese encephalitis virus; and no history of prior vaccination against West Nile virus with an investigational vaccine.

 Female-Specific Criteria:

 Negative beta-HCG pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential.

 A female participant must meet any of the following criteria:

 No reproductive potential because of menopause (one year without menses) or because of a hysterectomy, bilateral oophorectomy, or tubal ligation,

 or

 Participant agrees to be heterosexually inactive at least 21 days prior to enrollment and through Week 32 of the study,

 or

 Participant agrees to consistently practice contraception at least 21 days prior to enrollment and through Week 32 of the study by one of the following methods:

 condoms, male or female, with or without a spermicide

 diaphragm or cervical cap with spermicide

 intrauterine device

 contraceptive pills or patch, Norplant, Depo-Provera or other FDA-approved contraceptive method

 male partner has previously undergone a vasectomy

Exclusion criteria: :

 A volunteer will be excluded if one or more of the following conditions apply.

 Women:

 Breast-feeding or planning to become pregnant during the 32 weeks of study participation.

 Volunteer has received any of the following substances:

 Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the past six months. (Note that use of corticosteroid nasal spray for allergic rhinitis, topical corticosteroids for an acute uncomplicated dermatitis, or short-acting beta-agonists in controlled asthmatics are not excluded).

 Blood products within 120 days prior to HIV screening.

 Immunoglobulin within 60 days prior to HIV screening.

 Investigational research agents within 30 days prior to initial study vaccine administration.

 Live attenuated vaccines within 30 days prior to initial study vaccine administration.

 Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration.

 Current anti-TB prophylaxis or therapy.

 Volunteer has a history of any of the following clinically significant conditions:

 Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain.

 Autoimmune disease or immunodeficiency.

 Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteroids.

 Diabetes mellitus (type I or II), with the exception of gestational diabetes.

 History of thyroidectomy or thyroid disease that required medication within the past 12 months.

 Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years.

 Hypertension that is not well controlled by medication or is more than 145/95 at enrollment.

 Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.

 Malignancy that is active or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of the study.

 Seizure disorder other than: 1) febrile seizures under the age of two, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) a singular seizure not requiring treatment within the last 3 years.

 Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen.

 Allergic reaction to aminoglycoside antibiotics.

 Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within five years prior to enrollment, a history of suicide plan or attempt.

 Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.

 Active smoker within the past 5 years AND with 25 pack-years or greater smoking history.

 If age 51-65 years and with 3 or more of the 5 health risk factors noted below, the subject will be excluded:

 Current smoker (or quit smoking less than 28 days prior to enrollment)

 BMI greater than 35

 Fasting low density lipoprotein (LDL) greater than 159 mg/dL or fasting cholesterol greater than 239 mg/dL

 Systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg

 Fasting blood glucose greater than 125 mg/dL

 Note: The fasting blood tests require 8 hours fast prior to the blood draw. The results used for eligibility screening must be from tests completed no more than 12 weeks (84 days) prior to day of enrollment. The individual criteria for BMI (inclusion item 9), blood pressure (exclusion item 15) and smoking history (exclusion item 23) must also be met.


Study of Cidecin™ (Daptomycin) to Rocephin® (Ceftriaxone) in the Treatment of Moderate to Severe Community-Acquired Acute Bacterial Pneumonia Due to S. Pneumoniae

Summary: A COMPARASON OF CIDECIN™ (DAPTOMYCIN) TO ROCEPHIN® (CEFTRIAXONE) IN THE TREATMENT OF MODERATE TO SEVERE COMMUNITY-ACQUIRED ACUTE BACTERIAL PNEUMONIA DUE TO S. PNEUMONIAE
Inclusion criteria: inclusion criteria:

 Provide signed and dated informed consent.

 Adults, 18 years of age or older of either gender and of any race weighing up to 150 kg. Female patients of childbearing potential MUST be nonpregnant (confirmed by negative serum pregnancy test), nonlactating, and must be willing to practice reliable birth control measures during and for at least 30 days after treatment with study drug(s).

 Have a new pulmonary infiltrate on chest radiograph.

 Exhibit at least two of the following clinical symptoms of pneumonia on history or physical:

 Cough

 Production of purulent sputum or change in character of sputum

 Auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation (dullness to percussion, bronchial breath sounds, or egophony)

 Dyspnea or tachypnea

 Documented fever, defined as body temperature >38.0 ºC (100.4 ºF) taken orally; >38.5 ºC (101.2 ºF) tympanically; or >39.0 ºC (102.2 ºF) rectally or hypothermia, defined as core body temperature of <35.0 ºC (95.0 ºF)

 An elevated total peripheral white blood cell count (WBC >10,000/mm3); or >15% immature neutrophils (bands), regardless of total peripheral white count; or leukopenia with total WBC <4500/mm3.

 Hypoxemia with a PO2 < 60 mmHg (on room air) or O2 saturation <90% on room air

 Pneumonia which requires hospitalization and intravenous therapy for at least 5 days.

 Willingness to participate in this study and to complete all follow-up assessments.

Exclusion criteria: :

 Patients with Grade V pneumonia (based on Fine Score; Attachment 8).

 Patients in respiratory failure or incipient respiratory failure if the patient is not a candidate for mechanical ventilation (for any reason).

 Any of the following pulmonary conditions that may preclude interpretation of study results:

 Cystic fibrosis

 Primary lung cancer or another malignancy metastatic to the lungs

 Known bronchial obstruction or a history of post-obstructive pneumonia

 Known or suspected active tuberculosis.

 Severe shock (systolic blood pressure <90 mm Hg for >30 minutes not corrected by fluid bolus).

 Clinical evidence of bacterial meningitis (based on lumbar puncture results).

 Severe renal impairment (calculated creatinine clearance <30 mL/min).

 Moribund clinical condition: high likelihood of death during the first 48 hours.

 If HIV positive, known CD4 counts <200/mm3 or evidence of Pneumocystis carinii pneumonia.

 Inability to tolerate ceftriaxone or history of allergy to beta-lactam antibiotics (history of rash alone will not exclude a patient).

 Any individual previously treated with a potentially effective anti-infective agent for > 24 hours (or one dosing day) within 72 hours of enrollment, or prior treatment with any investigational drug (including experimental biologic agents) in previous 30 days or prior therapy with daptomycin.

 Patients who must continue HMG-CoA reductase inhibitor therapy (e.g., simvastatin, lovastatin, etc.) during the study treatment period.

 Anticipation that a second non-protocol systemic antibiotic will be required.

 Induction chemotherapy within 2 weeks prior to enrollment (or exogenous therapies which are anticipated to result in PMN counts of <200 mm3 during Treatment Phase), or patients with severe neutropenia (<200 PMN cells/mm3).

 Patients considered unreliable to return for visits or to comply with study procedures.

 Progressive neoplastic disease (Note: patients with malignancies in remission are eligible).

 Women who are pregnant or nursing/lactating.

 Patients presenting with nosocomial pneumonia (i.e., <14 days after discharge from a skilled nursing facility or hospital with an initial hospitalization of >=3 days duration).

 Clinical suspicion of Legionella pneumonia.


Arthroscopic Versus Open Stabilization for Traumatic Shoulder Instability

Summary: The purpose of this study is to compare arthroscopic and open shoulder stabilization procedures by measuring the disease-specific quality of life outcome in patients with traumatic unidirectional anterior instability of the shoulder at 2 and 5 years.~Hypothesis: There is no difference in disease-specific quality of life outcomes in patients with traumatic unidirectional anterior shoulder instability, undergoing an arthroscopic versus an open stabilization procedure.
Inclusion criteria: inclusion criteria:

 Clinical:

 Age 14 years or greater

 Diagnosis of traumatic anterior shoulder instability, made by meeting all of the following:

 Radiographic evidence or documented physician assisted reduction of anterior shoulder dislocation following a traumatic injury.

 Ability to elicit unwanted glenohumeral translation which reproduce symptoms with one of the following tests: anterior apprehension, relocation test, or anterior load and shift test

 Radiological:

 Closed growth plate on a standardized series of x-rays consisting of a minimum of an anteroposterior view, lateral in the scapular plane and an axillary view.

Exclusion criteria: :

 Clinical:

 Diagnosis of multidirectional instability (MDI) or multidirectional laxity with anteroinferior instability (MDL-AII), made by two or more of:

 Symptomatic (pain or discomfort) in inferior or posterior direction

 Ability to elicit unwanted posterior glenohumeral translation that reproduces symptoms with posterior apprehension tests, or posterior load and shift test

 Positive sulcus sign of 1cm or greater that reproduces patient's clinical symptoms

 Previous surgery on the affected shoulder other than diagnostic arthroscopy

 Cases involving litigation

 Significant tenderness of acromioclavicular/sternoclavicular joints on affected side

 Confirmed connective tissue disorder (ie: Ehlers-Danlos, Marfan)

['Open stabilization', 'Arthroscopic stabilization']

Open stabilization
Arthroscopic stabilization

['Joint Instability', 'Shoulder Dislocation']


Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914

Summary: This study will evaluate whether the experimental drug ulipristal acetate can shrink uterine fibroids in pre-menopausal women.
Inclusion criteria: inclusion criteria:

 Female gender-to evaluate effects in the target population for clinical trials.

 History of uterine leiomyoma causing symptoms of bleeding, pressure, or pain, as defined by the American College of Obstetrics and Gynecology (ACOG) practice bulletin:

 Excessive uterine bleeding will be evidenced by either of the following-profuse bleeding with flooding or clots or repetitive periods lasting for more than 8 days; or anemia due to acute or chronic blood loss;

 OR

 Pelvic discomfort caused by leiomyomata, either acute and severe or chronic lower abdominal or low back pressure or bladder pressure with urinary frequency not due to urinary tract infection.

 Uterine leiomyoma(ta) of at least 2 cm size.

 In good health. Chronic medication use is acceptable except for glucocorticoid use. Other chronic medication use may be acceptable at the discretion of the research team. Interval use of over-the-counter drugs is acceptable but must be recorded.

 Menstrual cycles of 24 - 35 days.

 Hemoglobin greater than 10 g/dL (for those wishing surgery); iron may be administered to improve red blood cell counts.

 Willing and able to comply with study requirements.

 Age 25 to 50.

 Using mechanical (condoms, diaphragms) sterilization or abstinence methods of contraception for the duration of the study.

 Negative urine pregnancy test.

 Body mass index (BMI) less than or equal to 33, if a surgical candidate or less than or equal to 35, if not a surgical candidate.

 Creatinine less than 1.3 mg/dL.

 Liver function tests within 130% of upper limit.

 If interested in hysterectomy, no desire for fertility.

Exclusion criteria: :

 Significant abnormalities in the history, physical or laboratory examination.

 Pregnancy.

 Lactation.

 Use of oral, injectable or inhaled glucocorticoids or megestrol within the last year.

 Unexplained vaginal bleeding.

 History of malignancy within the past 5 years.

 Use of estrogen or progesterone-containing compounds, such as oral contraceptives and hormone replacement therapy, within 8 weeks of study entry, including transdermal, injectable, vaginal and oral preparations.

 Use of agents known to induce hepatic P450 enzymes; use of imidazoles.

 Current use of Gonadotropin-releasing hormone (GnRH) analogs or other compounds that affect menstrual cyclicity.

 Follicle stimulating hormone (FSH) greater than 20 IU/mL.

 Untreated cervical dysplasia.

 Need for interval use of narcotics.

 Abnormal adnexal/ovarian mass.

 Use of herbal medication having estrogenic or antiestrogenic effects within the past 3 months.

 Contradiction to anesthesia, for women planning surgery.

 Genetic causes of leiomyomata.

 Previous participation in the study.

 Known recent rapid growth of fibroids, defined as a doubling in size in six months.

['ulipristal acetate 20 mg', 'ulipristal acetate 10 mg', 'placebo']

ulipristal acetate 20 mg
ulipristal acetate 10 mg
placebo


Cortisol Measurement During Intravenous Access With a Medical Clown

Summary: The purpose of this study is to determine whether the presence of a medical clown in a pediatric emergency department procedure room would reduce children's anxiety. The investigators hypothesize that this positive influence will be expressed as lower levels of the stress hormone (Cortisol) in the blood.
Inclusion criteria: inclusion criteria:

 Patients needing venous blood sampling or insertion of an intravenous canula

 Normal development according to parents

Exclusion criteria: :

 Critically ill children (e.g. shock, respiratory distress or failure)

 Children whose blood work or intravenous canula must be obtained rapidly for therapeutic reasons (e.g. antibiotic administration in a patient with severe bacterial infections)

 Known adrenal or pituitary disease

 Children who have received glucocorticoids during the preceeding six weeks


The Oral Microbiota as Reservoir for Systemic Opportunistic Pathogens

Summary: Small pilot studies with approximately 20 people per group support that eradication of the oral flora causes fewer exacerbations in chronic obstructive pulmonary disease (COPD) patients. The biological underpinning put forward is that eradicating the oral microbiome will eliminate a source of re-infection as the concentration of antibiotics prescribed to treat COPD exacerbations are not able to inhibit the bacteria in the oral biofilms that require 250 times higher concentration.~The specific aim is to investigate if adding advanced dental cleaning to COPD treatment can (i) lower the number of exacerbations and (ii) improve the COPD symptoms the coming 12 months. In an effort to explain the underpinning mechanism we will collect oral dental biofilm samples at baseline and follow up in the treatment and control group to investigate changes in the composition of the biofilm.~The subjects are selected by experienced COPD nurses. Exclusion criteria are having metastatic cancer or dementia. The COPD clinic informs the dental personal about COPD parameters, including spirometry data. At the dental clinic the patient answers a questionnaire, including a COPD assessment test (CAT) which has been validated extensively. The patients undergo a dental examination and are then randomized to test or control group. The test group go through supra- and subgingival scaling and scraping of the tongue as well as chlorhexidine rinse. The control group attends all visits.~All subjects go through the intervention after 6 months and are followed up after 12 and 24 months using questionnaire, dental plaque sampling and spirometry. The COPD nurses reviewing their medical records assess number of exacerbations.~A confirmation of the study hypothesis will be important in lowering the number of exacerbations in COPD patients, causing less suffering, less costs and less usage of antibiotics. If dental treatment is beneficial for exacerbation frequency it could be argued that dental treatment should be subsidized in this patient category.
Inclusion criteria: inclusion criteria:

 COPD arm - COPD Gold standard 1-4.

Exclusion criteria: :

 Physically unable to make it to the dental clinic.

['COPD Exacerbation', 'Pulmonary Disease, Chronic Obstructive', 'Dental Plaque']

COPD Exacerbation
Pulmonary Disease
Chronic Obstructive
Dental Plaque


Malaria Vaccine for Children in Mali

Summary: This study will evaluate the safety and immune response of children to an experimental malaria vaccine called AMA1-C1/Alhydrogel® (Registered Trademark) + CPG 7909. Malaria is an infection of red blood cells caused by a parasite, Plasmodium falciparum, that is spread by certain kinds of mosquitoes. It affects at least 300 million people worldwide each year, with more than 1 million deaths, mostly among children less than 5 years of age in sub-Saharan Africa. Malaria is the leading cause of death and illness among the general population of Mali in West Africa. Increasing drug resistance to P. falciparum and widespread resistance of mosquitoes to pesticides are reducing the ability to control the disease through these strategies. AMA1 C1 is made from a synthetic protein similar to a P. falciparum protein. It is combined with Alhydrogel and CPG 7909, substances added to vaccines to make them work better.~Children between 1 and 4 years of age who live in Bancoumana, Mali, and are in general good health may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests.~Participants are randomly assigned to receive three injections (shots) of either AMA1-C1 or a control rabies inactivated vaccine called Imovax® (Registered Trademark). The shots are given in the thigh muscle on study days 0, 56 and 180. After each shot, participants are observed in the clinic for 30 minutes. They return to the clinic for a physical examination six or seven times between each shot and then four more times over a 9-month period after the last shot. Blood samples are drawn at several of these visits to check for side effects of the vaccine and to measure the response to it. The total duration of the study is 21 months.~...
Inclusion criteria: inclusion criteria:

 Males or females aged greater than or equal to 1 to less than 4 years

 Known residents of the village of Bancoumana, Mali or its surrounding area

 Good general health as determined by means of the screening procedure

 Available for the duration of the trial (24 months from enrollment)

 Willingness to have child participate in the study as evidenced by parents/legal guardians signing or fingerprinting the informed consent document

Exclusion criteria: :

 Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, chronic infectious or renal disease by history, physical examination, and/or laboratory studies including urinalysis.

 Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the volunteer or the parent/legal guardian to understand and cooperate with the study protocol.

 Pre-existing known autoimmune diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, or autoimmune thrombocytopenia.

 Laboratory evidence of possible autoimmune disease determined by anti-dsDNA titer that equals or exceeds 25 IU.

 Laboratory evidence of liver disease (alanine aminotransferase [ALT] greater than the upper limit of normal of the testing laboratory).

 Laboratory evidence of renal disease (serum creatinine greater than the upper limit of normal of the testing laboratory, or more than trace protein or blood on urine dipstick testing confirmed by repeat testing).

 Laboratory evidence of hematologic disease (absolute leukocyte count less than 3000/mm(3) or greater than 14,500/mm(3), absolute lymphocyte count less than 1000/mm(3), platelet count less than 120,000/mm(3), or hemoglobin less than 8.5 g/dL).

 Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.

 Participation in another investigational vaccine or drug trial within 30 days of starting this study, or while this study is ongoing.

 History of a severe allergic reaction or anaphylaxis.

 History of allergy to nickel.

 Severe asthma. This will be defined as:

 Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or parenteral corticosteroids.

 Clinically significant reactive airway disease that does not respond to bronchodilators.

 Positive screening test for anti-Hepatitis C virus (anti-HCV).

 Positive screening test for Hepatitis B surface antigen (HBsAg).

 Known immunodeficiency syndrome.

 Use of systemic corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of starting this study.

 History of a surgical splenectomy.

 Receipt of blood products within the past 6 months.

 Previous receipt of an investigational malaria vaccine or of rabies vaccine.

 History of use of chloroquine or related compounds (amodiaquine or primaquine) within 8 weeks of study entry. Chloroquine and related compounds have the potential to interfere with CPG-induced activation of B cells and plasma dendritic cells.

 Previous administration of Verorab Trademark vaccine.

 Known thrombocytopenia or bleeding disorders.

 Known allergy to neomycin (a component of Verorab Trademark).


Role of Serum Total Antioxidant Level in Preterm Labor

Summary: The aim of this study is to detect the association between maternal serum antioxidant level and preterm labor.
Inclusion criteria: inclusion criteria:

 Preterm labor(pregnant between 28th and 37th week).

 Singleton pregnancy.

 Amnion membranes were intact

Exclusion criteria: :

 Past history of preterm labor or premature delivery.

 Urinary tract infections and any other infections.

 Poly- or oligohydramnios.

 Fetal distress, fetal or uterine anomaly.

 Membranes rupture and placenta pathology.

 Preeclampsia or intrauterine growth retardation


The Analgesic Efficacy of Periarticular Infiltration of Local Anaesthetic for Total Hip Replacement

Summary: Total hip replacement is a major surgical procedure usually associated with significant pain in the early postoperative period. In our hospital, total hip replacement is routinely performed under spinal anaesthesia with intrathecal bupivacaine local anaesthetic plus opioid in the form of preservative free morphine. The use of 'local infiltration analgesia' as an alternative postoperative analgesic technique has been investigated.In this technique the surgeon infiltrates the surgical site with a long-acting local anaesthetic and places a catheter under direct vision which remains in situ and is used to administer local anaesthetic in the postoperative period until such time as it is removed (when no longer deemed necessary for pain relief or at a pre-set time in the postoperative period e.g. 48 hours). We hypothesize that infiltration of the surgical site with peri- and intraarticular levobupivacaine local anaesthetic would be an efficacious pain management technique and would not be inferior to intrathecal morphine for postoperative pain management.
Inclusion criteria: inclusion criteria:

 Patients scheduled for unilateral total hip replacement

 Consent to spinal anaesthesia

 ASA Grade I to III

Exclusion criteria: :

 Patient refusal

 Mini-Mental Score < 25

 Allergy to bupivacaine, morphine, paracetamol, diclofenac

 Skin lesions/infection at site of injection

 Uncorrected renal dysfunction

 Coagulation disorders

 chronic pain condition other than hip pain


A Cohort Study to Determine the Incidence of Dengue Fever and to Build Capacity for Dengue Vaccine Trials in Dengue-endemic Regions of South Asia

Summary: The purpose of this study is to determine the incidence of dengue fever and to build capacity for dengue vaccine trials in dengue-endemic regions of South Asia.
Inclusion criteria: inclusion criteria:

 Subject and/or subject's parent(s)/legally acceptable representative(s) (LAR[s]) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. (e.g., willingness to go to the hospital/clinic for visit[s] in case of AFI, able to observe the signs of dengue and to understand how to take and report body temperature, etc.).

 Signed/thumb-printed (and video recorded if required by law) informed consent (and assent if applicable) must be obtained from the subject/subject's parent(s)/LAR(s) at the hospital/clinic or during a home visit. If the subject/subject's parent(s)/LAR(s) are illiterate, the informed consent form (ICF) (or informed assent form [IAF] when applicable) will be countersigned by an impartial witness.

 Subject is part of a household with at least one child (aged less than 18 years) and in which informed consent (and assent if applicable) to study participation was obtained from at least one adult and one child.

 Male or female aged between and including 6 months and 50 years at the time of enrolment.

 Subject who plans, at the time of enrolment, to remain at same residence/study area during the two-year study period.

Exclusion criteria: :

 Child in care.

 Participation (current or planned) in another epidemiological study or in a clinical trial that would conflict with the current study, based on investigator's judgement.

 Terminal illness based on investigator's judgement.

 Mental incapacity based on investigator's judgement.


Safety And Immunogenicity Of Novel Candidate Blood-Stage Malaria Vaccine P27A : Phase Ia/Ib

Summary: P27A study is designed as a randomized phase Ia/Ib trial to evaluate the safety and immunogenicity of the blood stage candidate vaccine P27A against P. falciparum - P27A antigen and associated adjuvant (Alhydrogel or GLA-SE) - in malaria non exposed European volunteers(Switzerland; phase Ia) and malaria exposed African volunteers (Tanzania; phase Ib).
Inclusion criteria: inclusion criteria:

 Phase Ia inclusion criteria:

 Healthy volunteers aged 18-45 years

 General good health based on history and clinical examination

 Written informed consent obtained before any study procedure

 Female volunteers practicing contraception before and up to 13 weeks after the last immunisation

 Available to participate in follow-up for the duration of study (34 weeks)

 Reachable by phone during the whole study period

 Phase Ib inclusion criteria

 Healthy male volunteers aged 18-45 years

 General good health based on history and clinical examination

 Written informed consent obtained before any study procedure

 Available to participate in follow-up for the duration of study (34 weeks)

 Reachable by phone during the whole study period

 Having always lived in an area of low malaria transmission

Exclusion criteria: :

 Phase Ia

CH-Alum50
CH-GLA2.5/50
TZ Ver
TZ Alum 50
TZ GLA 2.5/10
TZ GLA5/50
TZ GLA2.5/50


Carbetocin at Elective Cesarean Delivery Part 2

Summary: Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most common uterotonic drug used to prevent and treat PPH in North America, however, there are some limitations to its use. Oxytocin has a very short duration of action, which requires a continuous infusion to achieve sustained uterotonic activity. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg dose of carbetocin at elective Cesarean delivery to promote uterine contraction and prevent post partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin lasts 4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater efficacy rate. However, a dose response to determine the minimum effective dose of carbetocin has not yet been published. The investigators hypothesize that the minimum effective dose (ED90) is above 20mcgs and below 80mcgs in women undergoing elective Cesarean delivery.
Inclusion criteria: inclusion criteria:

 All patients planned for elective cesarean delivery under spinal anesthesia.

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

Exclusion criteria: :

 All patients who refuse to give written informed consent.

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

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

 All patients with hepatic, renal, and vascular disease,

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

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

Carbetocin Carbetocin Carbetocin Carbetocin Carbetocin


The Oral Contraceptive Pill for Premenstrual Worsening of Depression

Summary: To determine if augmentation with the oral-contraceptive pill containing drospirenone and ethinyl estradiol is more effective than placebo in the treatment of premenstrual breakthrough of depression.
Inclusion criteria: inclusion criteria

 Women who are non-smokers between the ages of 18-45 years (smokers 18-34 years);

 Regular menstrual cycles (26-34 days in length, predictable within 7 days) for the past 6 months;

 Determination that the antidepressant medication was initiated for the treatment of unipolar major depression, minor depression (depression, not otherwise specified), or dysthymia. Major depression and dysthymia will be evaluated through administration of the Mini-International Neuropsychiatric Interview (MINI). Minor depression will be evaluated by administration of the Structured Clinical Interview for Diagnosis-IV(SCID)10 section J.3.

 Use of an antidepressant for at least 3 months for treatment of a depressive disorder, with stable dose for at least 2 months. It is acceptable to be on more than one psychiatric medication as long as one of them is an antidepressant.

 Expected continued use of the same antidepressant at the same dose for the duration of the study;

 30% increase of the mid-follicular phase Montgomery-Åsberg Depression Rating Scale (MADRS) score to the late-luteal phase MADRS will be required for eligibility during the tracking phase of the study and will be assessed prospectively over 1 menstrual cycle.

 Normal pelvic exam and PAP smear in the past 12 months;

 Normal TSH at screen - if on thyroid medication, must be on a stable dose for 2 months or greater, and have a normal TSH at screen;

 Negative serum HCG at baseline, and negative urine HCG at visits 3 and 5;

 Normal potassium (K) levels at screen;

 Willingness to use barrier contraceptive methods during the study, if sexually active;

 Good general health.

Exclusion criteria: :

 Amenorrhea or irregular menstrual periods (defined as unable to predict within 7 days) during past 6 months

 Pregnancy or breastfeeding (serum HCG test administered at baseline study visit, and urine HCG at visits 3 and 5)

 Current cigarette smoking in women who are older than 34 years

 Presence of any of the following psychiatric and substance use disorders, based on administration of the MINI at the baseline study visit:

 Any history of mania or hypomania suggesting bipolar disorder Any lifetime history of a psychotic disorder

 Depression deemed by the physician investigator to be too severe to be treated in the study

 Use of benzodiazepines or antipsychotic to target premenstrual symptoms

 Luteal-phase dose adjustment of the antidepressant. Use of a hormone releasing IUD (intrauterine device)

 Use of an OCP or other systemic hormonal therapies (oral, transdermal or injection preparations of androgens, estrogens, or progestins) in the past 2 months;

 Any contraindication or previous adverse event to any OCP therapy;

 Current use of ketoconazole, rifampin, carbamazepine, topiramate, oxcarbazepine, modafinil, phenytoin, or phenobarbital (because of interaction with hormonal therapy).

 Current use of potassium-sparing agents, such as potassium-sparing diuretics (e.g., spironolactone), ACE inhibitors, angiotensin-II receptor antagonists, heparin, aldosterone antagonists, NSAIDS, potassium sparing diuretics or potassium-supplements (because of risk of developing arrhythmia with two potassium-elevating agents).

 Hepatic dysfunction, renal insufficiency, pulmonary, adrenal, or metabolic diseases (including elevated serum potassium levels, if known) that may put subject at risk when treated with study medication.

['Drospirenone and ethinyl estradiol', 'Placebo']

Drospirenone and ethinyl estradiol
Placebo


Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy

Summary: The purpose of this study is to evaluate the efficacy of pregabalin compared to placebo in reducing neuropathic pain associated with HIV neuropathy.
Inclusion criteria: inclusion criteria:

 Men and women, ages of 18 or greater

 Documented evidence of HIV-1 infection

 Documented diagnosis of HIV-associated Distal Symmetrical Polyneuropathy (DSP) with subjective sensory symptom of pain

 Pain starts in the feet

Exclusion criteria: :

 Subject has untreated vitamin B12 deficiency (serum B12 level <200 pg/ml) or if treated B12 deficiency -treatment is less than 6 months of B12 supplementation (injection or intranasal B12) prior to screening

 Diabetes mellitus requiring regular medical treatment (other than diet and exercise) or HbA1C >6.9

 Subjects with peripheral neuropathic pain that is not associated with HIV infection; including subjects with conditions such as: Post Herpetic Neuralgia (PHN), Diabetic Peripheral Neuropathy (DPN), familial neuropathies; compression related neuropathy, radicular pain, other infection related neuropathies (eg, leprosy); neuropathy related to: metabolic abnormalities; nutritional factors; vascular insults; inflammation; autoimmune disease; and malignancy


Orthostatic Hypotension and Diabetes Mellitus

Summary: Rationale: Orthostatic hypotension increases with age and is associated with increased vascular and all-cause mortality. The prevalence of orthostatic hypotension is also increased in diabetic subjects. In order to prevent related adverse events and vascular mortality it is of great interest to examine the prevalence of orthostatic hypotension in elderly diabetic subjects.~Objective: To examine the prevalence of orthostatic hypotension and associated adverse events in type 2 diabetic elderly subjects.~Study design: Cross-sectional observational study.~Study population: Elderly type 2 diabetic subjects (70 years and older).
Inclusion criteria: inclusion criteria:

 diabetes mellitus

 age (70 years and older)

Exclusion criteria: :

 Known autonomic dysfunction

 Neurodegenerative diseases

 Current malignancy

 Living in a nursing-home

 Irregular pulse

['Orthostatic Hypotension', 'Diabetes Mellitus Type 2']

Orthostatic Hypotension
Diabetes Mellitus Type 2


Handlebar Grip Related Injury Prevention (GRIP) Study: Are Exposed Metal Handlebar Ends a Risk Factor for Injury?

Summary: Cycling injuries are the 3rd most common mechanism of injury in 7-13 year olds[1]. Bicycle injuries have remained one of the commonest causes of paediatric abdominal trauma for over 60 years[2,3]. 15% of child cyclist injuries involve impact with a handlebar; two-thirds of those are abdominal injuries[4]. Handlebar impact is now the commonest mechanism of major paediatric abdominal injury[3]. Serious handlebar injuries often occur after apparently minor falls; they are not unique to riders performing stunts[5].~One small study found that the metal handlebar ends were often exposed on bikes of children sustaining severe abdominal injuries[6]. Most European safety standards do not test grip durability[7-10]. Day-to-day use can damage rubber grips, exposing the underlying metal handlebar tube.~This feasibility study aims to test the research methods that will be used in a subsequent nationwide multicentre study. The main study will investigate the association between injuries and handlebar grip condition.~Children attending study hospitals with any bicycle or kick scooter injury will be invited to participate. Parents of injured children will be invited to complete questionnaires regarding circumstances surrounding the injury and condition of the handlebar ends on the bike or scooter involved. Clinical information regarding the injury will also be collected. The handlebar end condition will be compared between children sustaining a handlebar end injury [Cases] and riders whose injury did not involve the handlebar [Controls].~If exposed handlebar ends are more prevalent amongst riders with handlebar end injuries, injury prevention strategies can focus on methods to prevent damage occurring to grips through day-to-day use. If no such association is found, prevention strategies can be focused elsewhere, such as on design of effective protective clothing.~Data collection for this feasibility study will occur between March 2015 and September 2015.~The Chief Investigator, Mr. Andrew Neilson, funds the feasibility study.
Inclusion criteria: inclusion criteria:

 Children 0-15 years inclusive

 Presenting to either of the study hospitals for assessment or treatment

 Sustained an injury or suspected to have sustained an injury (i.e. AIS >=0)

 Due to an incident involving any non-motorized bicycle, tricycle or kick scooter

Exclusion criteria: :

 Incidents where the injured child was involved in a motor vehicle collision

 Incidents where the injured child was injured by another rider (e.g. injured child run over by a cyclist)

 Incidents involving a bicycle fitted with 'bull bars'

 Patients for whom neither parent / guardian is fluent in English (if the history is clear from a parent, the patient will be eligible for inclusion)

 If an eligible patient is dead on arrival the family will not be invited to participate, and they will not subsequently be contacted

 If an eligible patient dies during their admission, they will be withdrawn from further involvement in the study and the family will not be contacted

['Injuries', 'Trauma', 'Wounds and Injuries', 'Children', 'Child']

Injuries
Trauma
Wounds and Injuries
Children
Child


Integrated Treatment for Comorbid Depression and Obesity in Adolescents

Summary: Lifetime prevalence of major depression is estimated at 28% by age 18 (Lewinsohn et al., 1999), with higher cumulative rates in females (35%) than males (19%). Approximately 17% of children and adolescents in the United States are obese as defined by a BMI above the 95th percentile, with more than 30% falling between the 85th and 95th percentiles (Ogden et al., 2008). Overweight children and adolescents are at increased risk for type 2 diabetes (Pinhas-Hamiel et al., 1996) and overwhelming risk for adult obesity (Guo et al., 1994). There is a substantial percentage of adolescents who are both overweight and depressed with estimates from clinical samples averaging 25%. Treatment of teens with comorbid medical and psychiatric conditions such as overweight/obesity and depression has received little to no attention in the psychosocial treatment research literature. Due to the large number of adolescents who are both depressed and overweight, developing a behavioral treatment that addresses both problems simultaneously has important public health significance. The purpose of this proposal is to combine treatments for depression and overweight to address these co-occurring conditions in one intervention. The long-term objectives of this research are to develop efficient and effective treatments for co-occurring physical and emotional disorders. The research program will be divided into 3 major phases: a development phase (Stage 1a), a pilot study phase (Stage 1b), and a revision phase. During the development phase (Stage 1a), a treatment for overweight teens and CBT treatment for depressed teens will be adapted into one integrated protocol that addresses depression using CBT techniques, an exercise component, and advice regarding healthy eating. As part of this phase, we will adapt existing intervention manuals and therapist training materials, and gain some initial clinical experience with the intervention via an open trial with 6 teens. During the randomized pilot study phase (Stage 1b), the integrated intervention will be compared to a control group receiving CBT treatment for depression alone (N=40 in total). During the pilot phase, the feasibility and acceptability of administering the program will be assessed. In addition, we will compare change in depressed mood at end of treatment and 6 month follow-up periods across the two groups. During the revision phase, the intervention manual will be further developed and refined, based on experiences and observations made during the development and pilot study phases.
Inclusion criteria: inclusion criteria:

 Adolescents must: 1) be between the ages of 12 and 18 years (18 year olds must still be in high school and living at home); 2) be at or above the 85th percentile with reference to age and gender-specific Body Mass Index (BMI); 3) have at least one parent available to participate in the treatment protocol; 4) speak English; 5) agree to study participation and random assignment; and 6) be available for follow-up. In order to meet the depressed mood criterion, adolescents must have a primary diagnosis of major depressive disorder (single or recurrent), based on the KSADS-PL with a CGI-Severity ≥ 3 for depression and CDRS ≥ 36. Participants must be healthy, as established by their primary care physician, in order to participate in the exercise program -

Exclusion criteria: :

 Adolescents will be excluded if: 1) they are currently receiving psychotherapy or participating in another weight loss program (only can have been in a weight loss program in the past); 2) they have a medical condition that would interfere with the prescribed dietary plan or participation in physical activity; 3) they are developmentally delayed such that the intervention materials will not be appropriate; 4) they are actively suicidal at intake; 5) they have not been on a stable dose of a psychostimulant for 6 months to ensure that a recently prescribed psychostimulant is not contributing to weight loss; 6) teens on an SSRI will not be allowed to participate due to potential effects of medication on weight loss; 7) they have a substance abuse or dependence diagnosis; or 8) they have failed a medication or psychotherapy trial for depression in the past.

['CBT for depression and healthy lifestyle plus exercise', 'CBT for depression']


The Effect of Granulocyte Colony Stimulating Factor (G-CSF) on Myocardial Function After Acute Anterior Myocardial Infarction, a Prospective Double Blind Randomized Placebo Controlled Study

Summary: The investigators applied G-CSF to patients 2 weeks after acute anterior MI and successful PCI to evaluate the efficacy and safety of G-CSF in improving myocardial function as cytokine which improve inflammation and mobilize stem cells from bone marrow for regeneration of myocardium.
Inclusion criteria: inclusion criteria:

 First anterior myocardial infarction.

 Low systolic ventricular function.

Exclusion criteria: :

 Bleeding tendency

 Contraindication to G-CSF

 Cardiogenic shock

 Hemodynamic instability

 Hepatic or renal disease

 Multivessel disease

['G-CSF', 'placebo infusion of normal saline']


Use of Magnetic Field Mapping in the Evaluation of Patients With Hypertrophic Heart Disease (Thick Heart Muscle)

Summary: The purpose of this research study is to further establish the diagnostic use of magnetocardiography (MCG) in patients with hypertrophic cardiomyopathy (HCM). The use of MCG has not been extensively studied in these patients. This pilot study will serve to further characterize abnormalities found on MCG in comparison to patients without hypertrophic cardiomyopathy. Additionally, the study will be used to understand whether MCG has any additional diagnostic utility in offering clinicians insight on the patient's disease state, thereby aiding in the development of treatment plans.~This research study is designed to test the effectiveness of the investigational use of magnetocardiography in patients with hypertrophic cardiomyopathy. The device itself has been approved by the U.S Food and Drug Administration (FDA).
Inclusion criteria: inclusion criteria:

 Any patient that is hemodynamically stable and is identified to have hypertrophic cardiomyopathy based on prior symptoms, 2D ECHO findings, genetic testing, and/or ECG voltage criteria.

 Patients that have signed informed consent after understanding the risks and benefits of participation. Individual age 16-17 with the consent and approval of a parent and /or legal guardian.

Exclusion criteria: :

 Patients with prior history of myocardial infarction, CAD demonstrated by stress test or angiogram, and/or CABG will be excluded from this study.

 Any patient that has undergone invasive treatment at the time of enrollment including procedures such as myomectomy and/or septal ablation. However, already enrolled subjects who have these procedures post-enrollment into the study will be eligible for future scans.

 Patients encountering any significant symptoms, chest pain, or who are hemodynamically unstable.

 Any patient with an ICD or pacemaker.

 Patients who are underage and do not have the consent of a parent and/or legal guardian.


Family Spirit Study

Summary: The goals of this study are to evaluate the effects of an in-home parenting education program, called Family Spirit, on parenting knowledge and skills and decreasing alcohol and substance use compared to a breast-feeding education. In addition, we will assess aspects of mother/child interaction.
Inclusion criteria: inclusion criteria:

 Native American pregnant teens or young women ages 12-22 years old at the time of conception.

 Women ages 20-22 years at the time of conception must be pregnant for the first time.

 Partners of pregnant teens must be between the ages of 12-24.

 Pregnant <28 weeks gestation and able to meet the requirements for completing the program in a timely way.

 An enrolled tribal member.

 Reside in the Reservation Service Unit Catchment Area and within 60 mile of the Indian Health Service Unit Headquarters.

Exclusion criteria: :

 Severe mental illness - schizophrenia, bipolar disorder, incapacitating depression, or Substance abuse/dependence in need of intensive and specific treatment

 Active legal problems - subjects will not be enrolled if they are incarcerated or if program participation has been made a condition of parole

 Ongoing social service involvement for abuse and neglect


Phase I Study Assessing the Ocular and Systemic Safety and Tolerability of OC-10X

Summary: The present study is intended to evaluate the safety and tolerability of topical OC-10X Ophthalmic Suspension in healthy human subjects. OcuCure Therapeutics, Inc. (Roanoke, VA) has developed a lead compound, known as OC-10X, which is a selective tubulin inhibitor under development for the treatment of Proliferative Diabetic Retinopathy (PDR) and Age-related Macular Degeneration (AMD). When administered as a topical eye drop, OC-10X has demonstrated both anti-angiogenic (inhibition) and angiolytic (regression) properties in animal models of AMD. Unlike other therapies, OC-10X provides the efficacy of a vascular targeting agent without the traditional toxicity and works downstream independently of growth factors. As demonstrated by OcuCure's preclinical data, tubulin inhibition using OC-10X has promise as a new therapeutic approach. PDR is a major cause of blindness in adults and is also caused by the growth of abnormal blood vessels. These new blood vessels are fragile and may hemorrhage into the vitreous. PDR affects up to 80% of all diabetics who have had diabetes for 15 years or more. If administration of OC-10X is well tolerated as a topical eye drop and is well tolerated systemically, then OC-10X will have the potential to provide benefits to patients with ocular diseases associated with angiogenesis.
Inclusion criteria: inclusion criteria

 Ability to provide approved written informed consent and comply with study-related procedures/assessments for the duration of the study, age > 18 years

 Corrected visual acuity >20/25 in both eyes

 IOP <21 mm Hg, with a difference between eyes of < 4 mm Hg

 Ability to tolerate and self-administer vehicle eye drops.

 Tolerance of a commercially available non-preserved, artificial tear solution

 Normal slit lamp exam and dilated fundoscopic exam within one week previous to dosing

 Normal clinical laboratory profiles for complete blood count, serum chemistry and electrolytes, and urinalysis with no clinically significant values

 Be neither overweight nor underweight for his/her height as per BMI scale (18.5-24.9)

 Female of childbearing potential:

 Is practicing an acceptable method of birth control for the duration of the study, such as condoms, foams, jellies, diaphragm, IUD, or abstinence; or

 Is postmenopausal for at least 1 year; or

 Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)

Exclusion criteria:

 Evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations

 History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological, hematological disease, diabetes, glaucoma, head-injury or coma

 History of significant recurrent bacterial, viral or fungal infections

 History of any psychiatric illness, which may impair the ability to provide written informed consent

 Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection

 Presence of values which are significantly different from normal reference ranges and/or judged clinically significant for haemoglobin, total white blood cells count, differential white blood cell count or platelet count

 Positive urinary screen testing of drugs of abuse (opiates, cannabinoids, amphetamines, barbiturates, benzodiazepines, cocaine)

 Presence of values, which are significantly different from normal reference ranges and/or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase, serum alanine aminotransferase, serum alkaline phosphatase, serum bilirubin, plasma glucose, serum cholesterol, serum electrolytes (sodium, potassium, chloride, calcium and phosphorus),serum proteins (albumin and globulin) and serum creatinine phosphokinase

 Clinically abnormal chemical and microscopic examination of urine defined as presence of red blood cells, white blood cells (>4/High Power Field [HPF]), glucose (positive) or protein (positive)

 Clinically abnormal electrocardiogram

 Regular smokers, who smoke more than 10 cigarettes daily, or have difficulty abstaining from smoking

 History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or have difficulty in abstaining from drinking

 Subjects who, through completion of this study, would have donated and/or lost more than 400 mL of blood in past 2 months

 History of ocular surgery, trauma, or chronic ocular disease

 Current use of contact lenses or discontinuation of contact lens use within 2 weeks of the first dosing day

 Any ocular abnormalities or ocular symptoms

 Use of ocular agents (including eye drops) within the past 2 months or anticipated use of ocular agents during the study period

 Systemic corticosteroid use within the past 6 months

 History or evidence of ocular infection, inflammation, blepharitis, or conjunctivitis with 2 months; history of herpes simplex keratitis

 Presence of a non-healing wound, ulcer, fracture, or any medical condition associated with bleeding.

 Use of antimitotic or antimetabolite therapy within 2 months of enrollment.

 Women who are pregnant or breastfeeding, or nonsterile or premenopausal women who refuse to use any form of contraception during and for at least 2 weeks following the final dose of study drug.

 Enrollment in another investigational drug or device study within 2 months of study entry.

 Known intolerance or hypersensitivity to any components/excipients in the study drug formulation.

 Planned use during the study of any ocular or systemic medication, with the exception of oral contraceptives and short-term use of over-the-counter analgesics.

['Proliferative Diabetic Retinopathy (PDR)']


Intraperitoneal Local Anaesthetic in Colonic Surgery

Summary: Aim:~The general aim of this research group is to improve the recovery of patients after abdominal surgery. The specific aim of this study is to conduct a randomized, double blinded, controlled trial to investigate the effect of intra-peritoneal local anaesthesia application on postoperative pain and post-operative fatigue. This will be conducted in the setting of an enhanced recovery after surgery program (ERAS).~Methods:~Patients will be randomised by computer generated random numbers and opaque envelope method. In the treatment arm patients will receive 10ml 0.75% ropivacaine diluted to 50mls with 0.9% saline soon after the creation of the laparotomy . In the placebo arm, 50mls of 0.9% normal saline will be used in a similar fashion. At closure, two small 2mm catheter belonging to the On-Q pain buster system will be placed in the peritoneal cavity. This will be attached to a pump which will contain either a 0.2% ropivacaine solution or 0.9% saline placebo running at 4mls/hr for 68 hours. All members involved in patient care (with the exception of one nurse) will be blinded to the above. After 68 hours the pump will be stopped and the catheter will be removed. Assessment of postoperative pain will be performed by visual analogue scale, and fatigue assessment will be done using the Identity Consequence Fatigue Scale (ICFS) at various intervals post-operatively. Blood tests for inflammatory markers including glucose, cortisol, CRP, albumin and several cytokines as well as local anaesthetic levels will be taken.~Significance to health:~This method of analgesia administration has not been investigated in open major colonic surgery. This trial has wide reaching implications, with the potential to improve pain and thus recovery after abdominal surgery.
Inclusion criteria: inclusion criteria:

 Consecutive patients undergoing open colonic resection at MSC under the ERAS program.

Exclusion criteria: :

 Known sensitivity to the local anaesthetic agents

 Patients who prefer not to participate (no consent gained)

 ASA greater or equal to 4

 Rectal resection

 Formation of stoma

 Current use of systemic steroids


Diagnosis of Colonic Adenomas by Bright Narrow Band Imaging (B-NBI)

Summary: Early detection of colo-rectal adenoma using colonoscopy can prevent occurrence of colon cancers. While colonoscopy is a standard technique, it can miss early cancers. To improve the detection rate, Narrow Band Imaging (NBI) was introduced in 2006. It has been shown to compare favorably with chromo-endoscopy in the sensitivity and specificity in the diagnosis of malignant colo-rectal neoplasms. The major drawback of NBI is that images become dark in the presence of blood and fecal matters. The bright-NBI is a prototype imaging technology that enables endoscopists to obtain better images in suboptimal conditions. The study proposes to compare the performance of colonoscopy using either white light or bright NBI in subjects undergoing screening colonoscopy in search for colon adenomas.~Purpose~To determine that bright -NBI is superior to WLE in detecting colorectal adenomas in average risk subjects undergoing screening colonoscopy.
Inclusion criteria: inclusion criteria:

 Asymptomatic subjects undergoing screening colonoscopy

 age > 40

 average risk subjects defined as those without a personal history of inflammatory bowel disease, colon adenoma or cancer or family history of Familial adenomatous polyposis (FAP) or Familial non-polyposis syndrome or first degree relatives having diagnosed to have colo-rectal carcinoma

 no colonoscopy in past 5 years

 ability to provide a written consent to trial participation

Exclusion criteria: :

 Patient age < 50

 Patients with prior colorectal surgery

 Pregnant or lactating women

 Colonoscopy done within the past 5 years

 Lack of consent

['Bright Narrow Band Imaging', 'White light Endoscopy']

Bright Narrow Band Imaging
White light Endoscopy


Role of Neurotransmission and Functional CNS Networks in Spasmodic Dysphonia

Summary: This study will examine how the brain controls speech in patients with spasmodic dysphonia, a voice disorder that involves involuntary spasms of muscles in the larynx (voice box), causing breaks in speech. Although the causes of spasmodic dysphonia are unknown, recent studies found changes in brain function in patients with the disorder that may play a role in its development.~People between 21 and 80 years of age with adductor spasmodic dysphonia may be eligible for this study. Candidates are screened with the following procedures:~Medical history and physical examination.~Nasolaryngoscopy to examine the larynx. For this test, the inside of the subject s nose is sprayed with a decongestant and a small, flexible tube called a nasolaryngoscope is passed through the nose to the back of the throat to allow examination of the larynx. The subject may be asked to talk, sing, whistle and say prolonged vowels during the procedure. The nasolaryngoscope is connected to a camera that records the movement of the vocal cords during these tasks.~Voice and speech recording to measure the type and severity of voice disorder. Subjects are asked questions about their voice disorder and their voice is recorded while they repeat sentences and sounds.~Participants undergo positron emission tomography (PET) and magnetic resonance imaging (MRI) of the brain, as follows:~PET: A catheter is placed in a vein in the subject s arm to inject a radioactive substance called a tracer that is detected by the PET scanner and provides information on brain function. [11C]flumazenil is used in one scanning session and [11C]raclopride is used in another. For the scan, the subject lies on a bed that slides in and out of the doughnut-shaped scanner, wearing a custom-molded mask to support the head and prevent it from moving during the scan. For the first scan the subject lies quietly for 60 minutes. For the second scan, the subject lies quietly for 50 minutes and is then asked to say sentences during another 50 minutes. The amount of radiation received in this study equals to a uniform whole-body exposure of 0.9 rem, which is within the dose guideline established by the NIH Radiation Safety Committee for research subjects. The guideline is an effective dose of 5 rem received per year.~MRI: This procedure uses a strong magnetic field and radio waves instead of X-rays to obtain images of the brain. The subject lies on a table that slides into the scanner, a narrow metal cylinder, wearing ear plugs to muffle loud knocking sounds that occur during the scan. Images of the brain structure are obtained while the subject lies still in the machine for 10 minutes. This is followed by functional MRI (fMRI) for 60 minutes, in which pictures are taken while the subject speaks, showing changes in brain regions that are involved in speech production.
Inclusion criteria: inclusion criteria:

 Healthy research volunteers and adult patients with ADSD and WC will be eligible for the study.

 Adult patients with ADSD will have clinically documented ADSD established by voice and speech testing and fiberoptic nasolaryngoscopy.

 Patients will be required to have:

 Intermittent uncontrolled voice breaks in vowels, liquids (r & l), semivowels (w & y) during speech in ADSD (at least 3 voice breaks), or

 Less prominent symptoms during whisper, singing, falsetto, or shout;

 Normal voice and vocal fold movement during protective laryngeal functions and emotional phonation, such as cough, laughter, cry.

 Adult patients with WC will have clinically documented WC established by history and neurological examination.

 Controls will be healthy subjects with a negative history of laryngeal, neurological, or psychiatric problems.

 All participants will be from 21 to 80 years old and right hand dominant.

 All participants should be able to perform a sequential finger-tapping task for 40 seconds consecutively

Exclusion criteria: :

 Subjects who are incapable of giving an informed consent.

 Pregnant or breastfeeding women until a time when they are no longer pregnant or breastfeeding.

 Subjects with past or present medical history of (a) neurological problems, such as stroke, movement disorders (other than SD and WC in the patient group), brain tumors, traumatic brain injury with loss of consciousness, ataxias, myopathies, myasthenia gravis, demyelinating diseases, alcoholism, drug dependence; (b) psychiatric problems, such as schizophrenia, major and/or bipolar depression, obsessive-compulsive disorder; (c) laryngeal problems, such as vocal fold paralysis, paresis, vocal fold nodules and polyps, carcinoma, chronic laryngitis. (d) ventricular arrhythmias, renal and hepatic insufficiency, vascular headache, or carcinoid syndrome.

 Patients who are currently taking medications known to affect GABA and dopamine receptor binding. Occasionally, patients report receiving such medication, although dopaminergic and GABA agonist/antagonists are not typically prescribed in these patients.

 Patients who received treatment with botulinum toxin injections into the laryngeal muscles within the past 3 months.

 Patients with vocal and hand tremor or muscle tension dysphonia.

 Subjects who have tattoos with contraindications to MRI, ferromagnetic objects in their bodies (e.g., implanted stimulators, surgical clips, prosthesis, artificial heart valve, etc.) that cannot be removed for the purpose of study participation.

 Subjects who received previous radiation exposure greater than 5.0 rem per year.

 WC patients who experience focal hand dystonia at rest.

 WC patients who have focal hand dystonia associated with trauma or a known neuroanatomic lesion or disease.

['Spasmodic Dysphonia', 'Focal Dystonia']


Detection of Aspergillus Fumigatus and Sensitization in COPD Patients With Bronchiectasis vs Without Bronchiectasis

Summary: A single center case-control study with 100 COPD patients will be organized to compare patients with and without bronchiectasis with regard to the presence of Aspergillus in sputum samples, Aspergillus sensitization and vitamin D. Induced sputum samples will be optimized for culture, Aspergillus galatomannan analysis and RT-PCR.~This study is part of a larger project in which we assume that chronic respiratory infection by Aspergillus fumigatus and the accompanying immune response play an important role in the development of bronchiectasis in COPD. We suspect that this mechanism is controlled by vitamin D and it fails by suppression of the vitamin D receptor by Aspergillus fumigatus.~The present study is designed by the Laboratory of pneumology and will be conducted in collaboration with the Laboratory of clinical bacteriology and mycology of the Catholic University of Leuven.
Inclusion criteria: inclusion criteria:

 Established diagnosis of COPD by medical doctor (based on clinical history or pulmonary function test)

 Smoking history of at least 10 pack-years

 CT Thorax available for assessment of bronchiectasis

 FEV1 >= 30%

Exclusion criteria: :

 Mechanical or non-invasive ventilation

 Other main respiratory diagnosis other than COPD

 Active mycobacterial disease

 Immunosuppression other than steroids

 Active cancer treatment

['Sputum induction', 'Skin prick test', 'Questionnaires']

Sputum induction
Skin prick test
Questionnaires

['Chronic Obstructive Pulmonary Disease']


Comparison of Volar Locking Plate Fixation Alone and Volar Locking Plate Fixation Plus Calcium Phosphate Bone Cement Augmentation for Distal Radius Fractures Patients Aged More Than 65

Summary: The incidence of distal radius fracture (DRF) increases with age, and thus, because of improving life expectancies, these fractures are set to become more common. Fractures of the distal radial metaphysis are known to be strongly related to osteoporosis, and as a result, the management of distal radius fractures in elderly patients is beset with difficulties.~Recently, more aggressive fracture fixation in the elderly has become a topic of interest, in the hope of increasing the rate of recovery to preserve the ability to live independently. Many elderly patients remain active well into their eighth and ninth decades, for example, some pursue activities, such as, golf and tennis, on a daily basis. The introduction of volar locking plating system has increased this interest. This system, which uses a fixed angle principle, has been proposed to be effective at maintaining good anatomic reduction, even in the elderly. However, there is a still concern about remaining metaphyseal defect after reduction of the osteoporotic DRF.~Injectable calcium phosphate bone cement (CPC) has been used to augment the remaining metaphyseal defect after fracture reduction including DRF, specially in osteoporotic old patients. The purpose of this randomized, prospective study was to investigate that additional CPC augmentation has any benefit over volar locking plate fixation in unstable DRF patient who is older than 65. The null hypothesis is that there is no difference of wrist functional outcomes, radiographic outcomes, and complications between treatment of volar locking plate alone and calcium phosphate bone cement as well as volar locking plate in unstable DRF patient who is older than 65.
Inclusion criteria: inclusion criteria:

 All patients older than 65 years old with an acute DRF were considered for inclusion for this study. Inclusion criterion of this study was an unacceptable closed reduction after one attempt of closed reduction. The criteria of unacceptable closed reduction included dorsal angulation of > 100, volar angulation of > 200, an articular gap or step off of >2 mm, radial inclination of <100, or radial shortening of > 5mm.

Exclusion criteria: :

 A preexisting severe illness

 An ipsilateral upper extremity injury

 A previous wrist injury

 Surgical delay of more than 2 weeks

 A concomitant ulnar neck fracture.

['calcium phosphate bone cement injection']


Ferric Carboxymaltose Treatment to Improve Fatigue Symptoms in Iron-deficient Non-anaemic Women of Child Bearing Age

Summary: research study of Ferric carboxymaltose to treat fatigue/exhaustion symptoms, believed to be due to iron deficiency.
Inclusion criteria: inclusion criteria:

 Signed informed consent prior to study specific procedures.

 Premenopausal, regularly menstruating women.

 Age ≥18 years.

 Body weight between 50 and 90 kg.

 Haemoglobin ≥115 g/L.

 Iron deficiency at screening defined as follows:

 S-ferritin level <50 ng/mL, AND, TfS <20%, OR,

 S-ferritin level <15 ng/mL.

 Serum C-reactive protein:

 <5 mg/L if not on oral contraception, OR,

 <20 mg/L if use of oral contraception.

 Minimum total score of 5 on the Piper Fatigue Scale (PFS) (mean of items 2 to 23).

 Negative pregnancy test (serum human chorionic gonadotropin (hCG) at screening.

 Normal levels of vitamin B12 and folic acid at screening.

 Adequate contraception during the study period and for 1 month following study completion.

 Availability and willingness to complete all study visits and procedures per protocol.

Exclusion criteria: :

 Haemoglobin level <115 g/L.

 Haemoglobinopathy.

 Haemochromatose.

 Major depressive disorder based on Patient Health Questionnaire (PHQ-9) (5 items with scores ≥2; one of which corresponds to question number 1 or 2).

 Any active or unstable concurrent medical condition (e.g., cancer, renal dysfunction, liver dysfunction (aspartate aminotransferase (AST); alanine aminotransferase (ALT) >3-fold upper limit), angina (Class IV).

 Known human immunodeficiency virus/acquired immunodeficiency syndrome, hepatitis B virus or hepatitis C virus infection.

 Chronic inflammatory disease (e.g., rheumatoid arthritis; inflammatory bowel disease).

 Documented history of clinically significant level of sleep apnoea defined as 5 or more episodes per hour of any type of apnoea.

 Intake of concurrent medications that could interfere with physical or mental performance (e.g., antidepressive, antihistamines, narcotic or any chemotherapeutic agents known to cause drowsiness).

 Important recent weight loss (>10% within the past month).

 Body weight <50 kg or >90 kg.

 Thyroid dysfunction, thyroid stimulating hormone >4 μU/mL.

 Intake of iron preparations 4 weeks prior to screening.

 Use of gestagens e.g., Implanon, Mirena, Depo-Provera for menstruation repression (see Section 7.7, Prohibited Therapy or Concomitant Treatment, page 35).

 Known hypersensitivity to FCM or to any other iron preparation.

 Pregnancy (positive hCG test at screening) or breast feeding.

 Participation in any other interventional trial within 4 weeks prior to screening.

 Inability to fully comprehend and/or perform study procedures or provide written consent in the Investigator's opinion.

 Subject is not using adequate contraceptive precautions during the study and for up to 1 month after the last dose of the study medication. A highly effective method of birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomised partner.

 Subject previously has entered this study.

 Subject will not be available for follow-up assessments.