Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose Design 9 System

Summary: The QuickClose Design 9 is a prospective, non randomized study, to evaluate the safety and efficacy of the QuickClose design 9 closure device.~patient undergoing a diagnostic or therapeutic angiogram procedure will be treated with the QuickClose Design 9. Patients will be monitored until 30 days after the procedure.
Inclusion criteria: inclusion criteria:

 patient/legal representative provides written informed consent

 Patient is scheduled for a coronary or peripheral diagnostic or interventional procedure

 Target vessel has a lumen diameter ≥ 6 mm

 Patient must be willing to comply with follow-up requirements

 Patient has a 5-7F arterial puncture located in the common femoral artery

Exclusion criteria: :

 Arterial puncture in the femoral artery of both legs

 Manual compression has been preformed on the ipsilateral arterial site within the previous 6 weeks

 Any closure system has been used on the ipsilateral arterial site within the previous 180 days

 Any reentry of the ipsilateral site is planned within the next 6 weeks

 History of surgical repair of blood vessels of the ipsilateral arterial site

 Patient is unable to ambulate at baseline

 Significant bleeding diathesis or platelet dysfunction

 Thrombocytopenia (Plt count ≤ 100,000)

 Anemia (Hgb ≤ 10mg/dl and/or Hct ≤ 30mg/dl)

 Hemophilia

 Von Willebrands disease

 Thrombophilia (i.e. factor 5 deficiency or other)

 ST-elevation myocardial infarction ≤ 48 hours prior to the cardiac or peripheral catheterization procedure

 Pre-existing severe non-cardiac systemic disease or pre-existing terminal illness

 Pre-existing systemic or cutaneous infection

 Receiving warfarin therapy within the last 14 days.

 INR results > 1.2 on day of procedure for any patient with a history of warfarin therapy

 Thrombolytic therapy (e.g. streptokinase, urokinase, t-PA) ≤ 24 hours prior to the cardiac or peripheral catheterization procedure

 Concurrent participation in another investigational device or drug trial

 Angiomax (bivalirudin) or other thrombin-specific anticoagulants or low molecular weight heparin ≤ 24 hours prior to the cardiac or peripheral catheterization procedure

 Planned arterial access at the same access site ≤ 30 days following the femoral artery closure procedure

 Evidence of a preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to start of femoral artery closure procedure

 Prior femoral vascular surgery or vascular graft in region of access site or contralateral common femoral artery

 Symptomatic leg ischemia in the target vessel limb including severe claudication or weak/absent pulse

 Absent of pedal pulse on ipsilateral side

 Pre-existing autoimmune disease

 BMI > 40 kg/m2

 The targeted femoral artery is tortuous or requires an introducer sheath length > 11 cm

 Fluoroscopically visible calcium, atherosclerotic disease, or stent ≤ 1 cm of the puncture site that would interfere with the placement of the VCD's plug

 Suspected bacterial contamination of access site

 Puncture through a vascular graft

 Double wall puncture

 Antegrade puncture

 Palpable Hematoma

 Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture

 Any Arterial and/or Venous access on the ipsilateral or contralateral groin other than target study access site

 Patient is not cooperative

 Intra-procedural therapeutic thrombolysis is preformed

 Uncontrolled hypertension at time of sheath removal (blood pressure ≥ 170 mmHg systolic and/or ≥ 100mmHg diastolic)

 Peripheral vascular disease on the ipsilateral arterial vessel (≥ 50% stenosis) or aneurismal disease of this vessel.

 Sheaths has been changed during the procedure

 Heparinized patients with elevated pre-closure ACT level≥ 300 seconds

 Patient has known allergy to any materials used in the VCD

 Patient is known to require an extended hospitalization (e.g. patient is undergoing CABG surgery)

 Prior or recent use of an intra-aortic balloon pump through the arterial access site

 Cardiogenic shock (hemodynamic instability requiring intravenous medications or mechanical support) experienced during or immediately post-catheterization

 Patient is known or suspected to be pregnant, or is lactating

 Patient has known allergy to contrast medium

 Any angiographic or clinical evidence that the investigator feels would place the patient at increased risk with the use of the VCD

 Required simultaneous ipsilateral or contralateral venous puncture

['Coagulation', 'Therapeutic Uses', 'Pharmacologic Actions']

Coagulation
Therapeutic Uses
Pharmacologic Actions


Investigation of the Effect of BONISTEIN(R) Bone Blend on Bone Mineral Density/Content and Biomarkers of Bone Health

Summary: The purpose of this study is to obtain information about the effect of a combination of genistein, PUFAs, vitamin K and D (BONISTEIN(R) bone blend) on bone health, determined as bone mass density/content and bone biomarkers after 6-months treatment in 70 healthy postmenopausal women. In addition, safety and tolerability will be investigated.
Inclusion criteria: inclusion criteria:

 Female

 Age 45 (inclusive) to 55 years (inclusive)

 Race: Caucasian

 Non-smokers / Smokers up to 10 cigarettes/day

 Postmenopausal hormone status: 1-3 years since the last spontaneous menstrual bleeding and a follicle-stimulating hormone concentration (FSH) >75 IU/ml and 17-estradiol (E2) of < 20 ng/L

 Years since menopause between 1-3 years

 Natural menopause or total hysterectomy with bilateral salpingo-oophorectomy

 Subjects with E2 results within the inclusion criteria range will be assessed on an individual basis if FSH level is less than 75 IU/ml

 Assessed as age-related healthy, based on a pre-study examination including medical history, physical examination, ECG, vital signs and clinical laboratory. The examination will be performed by a MD at the study site within 1-2 months prior planned study start for the individual subject.

 Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements.

 Ability to understand, speak, read and write the English language

Exclusion criteria: :

 T-score < -2.5 at total hip and spine (either or both)

 Suspect lack of compliance

 BMI > 30 or < 21

 Use of HRT within the previous 6 months

 Use of any drug which might interfere with bone-metabolism (bisphosphate, estrogen receptor modulators, calcitonin) within the previous 12 months

 Systematic practice of high intensity exercise

 Vegetarian nutrition or any other extreme dietary habits

 Use of dietary supplements while on study, except multi vitamin. No wash out period for supplements - must stop before run-in period and refrain until the end of the study.

 Participant in any other study or donation of blood during the last 30 days before start of each dosing phase (T0).

 Total genistein blood concentrations of > 100 ng/ml measured at pre-study examination

 Known hypersensitivity or allergy to soy, purified isoflavones, peanuts, fish, and/or genistein.

 Hepatitis screen (serology) positive or not performed

 Drug screen positive or not performed (at least amphetamines, benzodiazepines, cannabinoides, opiates).

 Subjects on a weight reduction program or a medically supervised diet

 Unexplained weight loss or weight gain of more than 5 kg in the three months prior to the study

 History of liver or pancreas diseases

 Cardiovascular diseases, even AV-block I0 (PQ time > 220 ms) and QTc time > 450 ms

 History of breast cancer, endometrial cancer and other malignancy except basal and squamous cell skin cancer

 History of thromboembolism or deep venous thrombosis

 Any fractures within one year except for fingers, toes and facial bones

 Subjects with susceptibility for fractures as a history of being a faller

 Endometrial thickness > 6 mm

 Endometrial polyps

 Untreated hypo- or hyperthyroidism

 Insulin-dependent diabetes mellitus, Crohn's Disease, Cushing Disease etc.

 Any condition which might interfere with absorption of the investigational product (e.g. malabsorption syndrome)

 Co-medication: Anticoagulants, parathyroid hormones, corticosteroids, thiazide diuretic

 Subjects who, during the previous 24 months, received a total fee payment greater than 5'000 USD for participation in biomedical research


Study of Intravenous Amino Acid Infusion to Prevent Contrast Dye Mediated Renal Damage

Summary: Exposure to radiographic contrast dye during coronary angiography is well known to cause either transient decreases in renal function or acute renal failure. Although the overall incidence is low, acute renal failure occurs most frequently in patients with both diabetes and chronic renal failure where the average reported incidence is upwards of 20%. The etiology of contrast-induced nephropathy is related to acute decline in renal blood flow following dye exposure resulting in ischemic injury at the level of the medulla. The development of acute renal failure following radiocontrast dye administration is significant because it contributes to morbidity and mortality in patients at risk.~The administration of amino acids, either through intravenous infusion or a protein meal, results in a substantial increase in renal plasma flow (RPF) and glomerular filtration rate (GFR). In both healthy subjects and in those with chronic renal failure, an amino acid infusion produces a 20% rise in GFR and effective RPF.~We hypothesize that the 20% rise in effective RPF and GFR following an amino acid infusion will counteract the radiocontrast dye-induced vasoconstriction and reduce the renal toxicity of contrast medium in a group of high-risk patients.
Inclusion criteria: inclusion criteria:

 Greater then 18 years of age

 Referral for coronary angiography

 Type 1 or type 2 diabetic requiring insulin or oral hypoglycemic agents

 Stable serum creatinine concentration (140 to 300 μmol per liter for men or 125 to 300 μmol per liter for women or a creatinine clearance not greater than 60 ml/min (as calculated by Cockcroft-Gault equation)

 Non diabetic subjects with a stable serum creatinine concentration of 160 to 300 µmol per liter for men and 140 to 300 µmol per liter for women.

 Stable renal function defined as no documented rise or fall in serum creatinine by more then 44 umol/L in the preceding 2 weeks

Exclusion criteria: :

 Refusal or inability to give consent

 Pregnant

 Non-elective coronary angiography

 Recent administration (within 21 days) of iodinated intravenous contrast dye

 Recent administration (within 21 days) of non-steroidal anti-inflammatory drugs (excluding aspirin), aminoglycoside antibiotics or chemotherapeutic agents

 Severe/unstable diabetics requiring emergency room or inpatient therapy in the previous 21 days

 Compensated or decompensated hepatic failure

 Renal transplant

['Contrast Nephropathy', 'Renal Failure']


African American Community Health Project on Cardiovascular Disease

Summary: The investigators seek to demonstrate that interactive physician-led education through partnership with an African American church will improve awareness and knowledge of cardiovascular disease in the African American community and will result in objective improvement in major risk factors associated with cardiovascular disease (CVD).
Inclusion criteria: inclusion criteria:

 African American adults > 18 years old
Exclusion criteria:

['Cardiovascular Diseases', 'Cardiovascular Risk Factor']

Cardiovascular Diseases
Cardiovascular Risk Factor


Check Yourself Study

Summary: The proposed study is a randomized controlled trial that compares the effectiveness of an electronic personalized health screening app incorporating motivational feedback (i.e., Check Yourself) to usual care. The purpose of this study is to determine whether Check Yourself is more effective than usual care in reducing health risk behaviors and improving quality of care among adolescents receiving primary health care services.
Inclusion criteria: inclusion criteria:

 Eligible individuals will be 13-18 years old who have an appointment to see a provider at a participating clinic and will be able to read and comprehend English.

Exclusion criteria: :

 Individuals will be excluded from the study if:

 they do not meet age requirements,

 do not have an appointment at a participating clinic,

 lack the means to complete follow-up interviews (i.e., has neither telephone not internet access),

 have a sibling who has/is being enrolled in the study and/or

 are not able to read or comprehend English.

['Health Risk Behaviors', 'Health Care Services Quality of Care']

Health Risk Behaviors
Health Care Services Quality of Care


Diagnostic Accuracy of Serum Bilirubin in the Prediction of Perforated Appendicitis

Summary: Hyperbilirubinemia is reported to be a positive predictor in diagnosing perforated appendicitis. Therefore we analysed the diagnostic accuracy of serum bilirubin in discriminating between perforated and simple/no appendicitis.~Methods:~All consecutive patients undergoing appendectomy for suspected appendicitis from May 2009 to August 2011 were analysed. Primary endpoint was the diagnostic accuracy of serum bilirubin levels to detect perforated appendicitis.
Inclusion criteria: inclusion criteria:

 all patients undergoing appendectomy for suspected appendicitis

Exclusion criteria: :

 preexisting liver disease


STA-5326 Meslylate to Treat Gut Inflammation Associated With Common Variable Immunodeficiency

Summary: This study will determine whether an experimental medicine, STA-5326 mesylate, is safe to use in patients with common variable immunodeficiency (CVID) who have inflammation of the gut. It will also determine if patients who take this drug show improvement in their symptoms, decrease in inflammatory chemicals in the gut, changes in their immune cells, and improvement in how their gut is functioning to absorb food.~Patients between 18 and 75 years of age with CVID and chronic diarrhea or involuntary weight loss of more than 5 percent of their past body weight over the past 12 months may be eligible for this study. Candidates are screened with a review of their medical records, a medical history and physical examination, blood, urine and stool tests, chest x-rays and skin test for exposure to tuberculosis, and a hydrogen breath test. For the latter, breath samples are collected before and every 20 minutes (for 2 hours) after the subject drinks a sugar solution. This test determines the digestive effects of bacteria in the upper intestine. Samples are collected by having the subject blow into a balloon.~Participants undergo the following tests and procedures:~Immune System and Gastrointestinal Evaluation~48-hour stool fat collection (measures the amount of undigested fat in the stool): Subjects keep a diary of what they eat for a 48-hour period. At the beginning of the 48 hours they take two dye capsules and then take another two capsules 48 hours later. They collect a stool sample when they pass the second set of capsules in their bowel movement. An additional 24-hour stool collection is tested for loss of protein in the stool.~D-xylose absorption test (measures the ability of the gut to absorb nutrients): Subjects drink a solution of d-xylose (a sugar substitute). Blood samples are collected before and 1 hour after drinking the solution.~Upper endoscopy: A thin flexible lighted tube is advanced through the mouth to evaluate the esophagus, stomach and beginning of the small intestine.~Lower endoscopy: A thin flexible lighted tube is advanced through the rectum to evaluate the colon.~Treatment Period (Study days 1 to 57)~Physical examination - study days 1, 8, 15, 29, 43 and 57~Blood samples to test the levels of STA-5326 in the blood. On study days 1 and 57, samples are collected before the medication dose and 1, 2, 4, 6 and 8 hours after the dose; on day 29, one sample is collected before the medication dose.~Blood samples for routine safety testing - study days 1, 8, 15, 29, 43 and 57~Medication history - study days 1, 8, 15, 29, 43 and 57~Interview about pain, discomfort, and well being - study days 1, 8, 15, 29, 43 and 57~Pregnancy test for women who can become pregnant - study days 15, 43, and 57~D-xylose absorption test - study days 29 and 57~Electrocardiogram - study days 29 and 57~Urine test - study days 29 and 57~Blood test for research on immune cells - study day 57~Repeat endoscopies and studies of gut function (24- and 48-hour stool collections)~Follow-up period (Day 85 and day 113)~-Physical examination, blood tests, medication history, questions about pain, discomfort and well being
Inclusion criteria: inclusion criteria:

 A subject is eligible for the study if all of the following criteria are met:

 Has given written informed consent prior to screening.

 Is male or female aged 18 through 75 years.

 Has CVID diagnosed definitively prior to screening (based on the IUIS criteria).

 Has a documented, unintended loss of greater than 5% of their body weight over the last year or requires nutritional supplements to maintain his/her body weight OR has chronic diarrhea defined as a complaint of liquid stools for at least 4 consecutive weeks (and an output of greater than 200 g stool/24hr on a diet of at least 1600 calories with 60 g fat.)

 If taking oral antibiotics chronically, must have used a stable dose of the antibiotic continuously for at least 2 weeks prior to start of screening period.

 Not taking any potential CYP3A4 inhibitors/inducers (e.g., macrolide antibiotics, HIV protease inhibitors, antifungals, grapefruit juice, St. John's Wort).

Exclusion criteria: :

 A subject is excluded from the study if any of the following criteria are met:

 General Criteria:

 Has any clinically significant disease (e.g., renal, hepatic, neurological, cardiovascular, pulmonary, endocrinologic, psychiatric, hematologic, urologic, or other acute or chronic illness) that in the opinion of the investigator would make the subject an unsuitable candidate for this trial.

 Is a woman who has a positive serum pregnancy test or who is breast-feeding.

 Is a woman of childbearing potential or a man who does not agree to use two forms of contraception during the course of the study and follow-up period.

 Has hypersensitivity to any of the components of STA 5326 mesylate drug product.

 Has any of the following clinical chemistry values:

 AST greater than 2.5 x upper limit of normal (ULN).

 ALT greater than 2.5 x ULN.

 Serum bilirubin greater than 1.5 x ULN.

 Serum creatinine greater than 1.5 x ULN.

 Alkaline phosphatase greater than 2.5 x ULN.

 Has a hemoglobin level less than 9 g/dL or hematocrit less than 30%.

 Has a Prothromin Time INR greater than 1.3 or a Partial Thromboplastin Time greater than 3 sec compared to control value.

 Has the following cell counts (cells/microliter):

 Platelet count less than 90,000 or greater than 800,000.

 White blood cell count less than 1,500.

 Neutrophil count less than 900.

 Has a current infection requiring intravenous antibiotics, a serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia).

 Has a history of cancer within the past 5 years, with the exception of excised basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ.

 Had a dependency for any illicit drug, chemical, or alcohol within the past 5 years.

 Has a history of active tuberculosis (or a CXR with findings suggestive of old TB infection including calcified nodular lesions, apical fibrosis, or pleural scarring), acute or chronic hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).

 Gastrointestinal Criteria:

 Has a stool sample positive for gastrointestinal infection during screening.

 Has a positive hydrogen breath test

 Prior Medication Criteria:

 Received parenteral corticosteroids within 1 month prior to receiving study drug. The use of short-term or single-dose corticosteroids as a pretreatment regimen for IVIG is acceptable.

 Received any investigational drug within 3 months prior to receiving study drug.

 Received cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 2 months prior to receiving study drug.

 Received any biological product (e.g., infliximab, adalimumab, natalizumab, etc.) within 3 months prior to receiving study drug.

 Ever received treatment with STA-5326 mesylate, anti-IL 12 antibodies, or other specific IL 12 inhibitors.


Exposure to Neurotoxins as Risk Factors for ALS

Summary: Chemicals called neurotoxins can harm the nervous system. Amyotrophic lateral sclerosis (ALS) is a progressive disease affecting movement. Researchers have studied many possible causes of ALS, including injury, diet, and exposure to chemicals, but these studies were inconclusive.~The purpose of this study was to determine whether exposure to lead or other neurotoxins can contribute to ALS. The study also evaluated lifestyle and dietary patterns. The study was completed in 1994-1996.~One hundred eighty-two participants took part in this study 110 patients with ALS and 72 who did not have ALS. Each completed a questionnaire concerning lifestyle, diet, and residential, job, and medical history. Participants contributed 50 cc of blood, used to measure lead, as well as clippings of their toenails, used to measure mercury and other metals. They then underwent an XRF test (an X-ray procedure) to measure the level of lead in their shinbones and knees. Genes related to ALS or susceptibility to lead exposure were also evaluated.
Inclusion criteria: inclusion criteria:

 Cases were eligible to participate in the original study if (1) they had received a diagnosis of ALS within 2 years; (2) they lived in New England at least half the year; (3) they spoke English; (4) they were mentally and physically able to participate. The same inclusion criteria were used for controls.

Exclusion criteria: :

 Potential controls were excluded if they had a physician diagnosis of a neurodegenerative disease, polio, post-polio syndrome, or nondiabetic neuropathy.

 Pregnant women were excluded from both case and control groups.


Study of a New Generation Botulinum Toxin A2NTX to Treat Spasticity After Stroke

Summary: To test the safety and efficacy of a new generation botulinum toxin preparation A2NTX for treating stroke patients with lower limb spasticity.~we study the degree of spasticity in the ankle and knee joints, and walking speed in 30 patients with stroke before and after injecting 300 units of BOTOX or A2NTX in a blinded manner as for the patient, the physician, and the examiner.~we also assess the safety of A2NTX and compare it to that of BOTOX.
Inclusion criteria: inclusion criteria:

 patients with lower limb spasticity after stroke

 duration more than 6 months

 Modified Ashworth Scale of ankle joint more than 2

Exclusion criteria: :

 patients with previous botulinum toxin injections to lower limbs

 patients with serious hepatic, renal or cardiac dysfunction

 patients with respiratory failure

 patients who cannot understand the instructions


Group B Streptococcal Carrier State Prevalence Among Arab Pregnant Women in Northern Israel District

Summary: The incidence of early neonatal GBS (group B Streptococcus) infection in the Nazareth Hospital through the years 2006-2013 has been higher compared to the national average. On reviewing all the cases of infants with early GBS infection, revealed that some of these infants were born to mothers who are not included in any of the high-risk groups that need to have prophylactic antibiotic treatment before delivery. Therefore, the question was whether pregnant Arab women in the North district of Israel have a higher GBS carrier state rate than the general rate in Israel?
Inclusion criteria: inclusion criteria:

 Age: 18 to 40

 Origin: Arab

 Gestational age: 34 to 40

Exclusion criteria: :

 Rupture of membranes

 Women in active labor who has had one or more vaginal examinations.

['vaginal/anal swab for GBS from all participants']

['Streptococcus B Carrier State Complicating Pregnancy']


Efficacy of Bromopride and Simethicone Versus Bromopride in Functional Dyspepsia

Summary: Multi-center, randomized, superiority, double blind clinical trial to asses the efficacy of fixed-dose combination of bromopride and simethicone versus isolated bromopride on research participants diagnosed with functional dyspepsia.
Inclusion criteria: inclusion criteria:

 Signed Informed Consent;

 Participants aged 18- 70 years;

 Clinical diagnosis of functional dyspepsia according to Rome III criteria;

 Minimum score of 22 points in PADYQ questionnaire

Exclusion criteria: :

 Diagnosis of gastroesophageal reflux disease, irritable bowel syndrome, inflammatory bowel disease, gallstones, strongyloidiasis, giardiasis or ascariasis, clinical disease or significant psychological;

 Positive diagnosis for Helicobacter pylori;

 Clinically significant organic diseases in the HDE (High Digestive Endoscopy) prior to randomization;

 History of esophageal surgery, gastrointestinal or other intra-abdominal surgery;

 Hypersensitivity to the components of the formulations;

 Allergy tartrazine yellow dye;

 Allergy to aspirin;

 Use of PPIs, H2 blockers, prokinetics, antibiotics, prostaglandins or bismuth salts in the last week before the screening visit;

 Use of NSAIDs or aspirin more than two days a week (except AAS <325mg / day), other drugs that induce gastrointestinal symptoms;

 Pregnant women or women without adequate contraception;

 Advance Participation in clinical trial protocols in the last twelve (12) months (CNS Resolution 251 of August 7, 1997, Part III, subsection J), unless the investigator considers that there may be direct benefit to it;

 Changes in hematological and biochemical tests: hemoglobin less than 12 g / dl, results with value 2 times the reference for AST, ALT, Gamma GT and alkaline phosphatase;

 Diagnosis of neurological or psychiatric diseases or decompensated diabetes;

 Use of drugs with anticholinergic action, narcotic analgesics, sedatives, hypnotics or tranquilizers;

 Alcoholism or sporadic use of alcohol and illicit drug use.

['FDC Bromopride 10 mg and Simethicone 80 mg', 'Bromopride 10 mg']


Weight Gain Prevention

Summary: The specific aim of the proposed project is to test two separate self-regulation interventions to prevent weight gain in young adults, one based on making sustained small changes in behavior to prevent weight gain and the other on making periodic larger behavior changes resulting in weight loss.
Inclusion criteria: inclusion criteria:

 Age 18-35

 Body mass index between 23 and 30

 Interested in preventing weight gain

Exclusion criteria: :

 BMI outside of range specified

 Age outside of range specified

 History of or current eating disorder or substance abuse

 Recent weight loss greater than 5% of weight

 Currently in another research study that would interfere

['large changes in eating and activity', 'small changes in eating and activity']

large changes in eating and activity
small changes in eating and activity


Pilot Study of a Multicomponent Nurse Intervention to Reduce Delirium in Hospitalized Older Adults

Summary: Objectives: To analyze if a multicomponent nurse-led intervention randomized clinical trial (MID-Nurse Study) is feasible (Pilot study), and can reduce the incidence, duration, and severity of delirium in hospitalized older adults in an AGU.~Design: Parallel-group Double-blind Randomized Clinical Trial (Pilot Study). Setting: AGU Complejo Hospitalario Universitario from Albacete (Albacete, Spain).~Participants: 50 patients ≥ 65 years hospitalized in the AGU (21 intervention group, 29 control group).~Interventions: After risk factor analysis, all participants in the intervention group (IG) received a daily multicomponent intervention (orientation, sensorial deficit, sleep, mobilization, hydration, nutrition, drugs, elimination, oxygenation, pain) by the intervention nurses. The control group (CG) received usual care.~Measurements: Delirium presence was determined daily with the Confusion Assessment Method (CAM), and delirium severity with the Delirium Rating Scale-Revised-98 (DRS). Mortality, days of hospitalization, use of physical restraint measures, and use of drugs for delirium control (neuroleptics and benzodiacepines) were also recorded.
Inclusion criteria: inclusion criteria:

 Patients with an age equal or older than 65 years

 Hospitalized at the Acute Geriatric Unit of the Complejo Hospitalario Universitario of Albacete

 Valid signed informed consent by the patient or legal representative.

Exclusion criteria: :

 Agonic situation

 Non-Spanish speaking

 Severe cognitive decline (Reisberg´s Global Deterioration Scale = 7)

 Patients sharing the same room with a previously included participant


Bioequivalence Study of Hydrochlorothiazide 50mg Tablets Under Fasting Conditions

Summary: To compare the single-dose oral bioavailability of hydrochlorothiazide 50 mg tablet of Ohm Laboratories (A subsidiary of Ranbaxy pharmaceuticals USA) with hydrochlorothiazide 50 mg tablet of IVAX Pharmaceuticals, USA in healthy, adult, human, male subjects under fasting condition
Inclusion criteria: inclusion criteria:

 Aged 18-45 years.

 Were neither overweight nor underweight for his height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.

 Had voluntarily given written informed consent to participate in this study.

 Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.

Exclusion criteria: :

 - Had history of allergy or hypersensitivity to hydrochlorothiazide or any other sulphonamide derived drugs.

 Had history of diarrhoea, vomiting or headache within past two weeks

 Had history of hypotension (systolic BP<100 mmHg)

 Had history of allergy or bronchial asthma

 Had history of muscle cramps or muscle weakness

 Had history of any anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura, Systemic Lupus Erythematoses(SLE)

 Had history of aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia

 Had history of anuria or history/evidence of any renal disorder including renal failure, renal dysfunction, interstitial nephritis.

 Had history of erythema multiforme including Stevens- Johnson syndrome or exfoliative dermatitis including toxic epidermal necrolysis

 Had history of pancreatitis

 Had history/evidence of jaundice or any hepatic or gall bladder disease

 Had history of hyperglycemia, glycosuria, hyperuricemia or gout.

 The subject had a history/evidence of any electrolyte imbalance, serum sodium < 135 mEq/L, serum potassium < 3.5 mEq/ L.

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

 Had presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.

 Had presence of values, which are significantly different from normal, reference and/or judged clinically significant for haemoglobin, total white blood cells count, differential WBC count or platelet count.

 Had positive for urinary screen testing of drugs of abuse (opiates or cannabinoids)

 Had 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 (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol.

 Had clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), epithelial cells (>4/HPF), glucose (positive) or protein (positive).

 Had clinically abnormal ECG or Chest X-ray.

 Had history of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes or glaucoma.

 Had history of any psychiatric illness, which may impair the ability to provide, written informed consent.

 Were regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.

 Had 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 for the duration of each study period.

 Had used any enzyme modifying drugs within 30 days prior to Day 1 of this study.

 Had participated in any clinical trial within 12 weeks preceding Day 1 of this study.

 Subjects who, through completion of this study, would have donated and/or lost more than 350 mL of blood in the past 3 months.


Differential Diagnosis of STA-PSV in Thyrotoxicosis

Summary: Aim: Graves's disease and thyroiditis can both characterized with thyrotoxicosis, but their clinical outcome and therapy is quiet different. Measurement of iodine uptake is the gold standard to differential diagnosis the thyroiditis or Graves's disease. But the iodine uptake is limited for its availability in china and easily influenced by medicine or food contained iodine.The blood pattern of thyroid CFDS is useful for differentiate the cause of thyrotoxicosis.Most previous studies using the descriptive pattern of thyroid CFDS is easily varied by operator subjective judgement. This study is focus on the role of peak systolic velocity of thyroid superior artery in differential diagnosis of thyrotoxicosis. Methods: Patients with thyrotoxicosis symptoms without recent medicine history were enrolled in two clinical center. Its thyroid function, iodine uptake , CFDS of thyroid and peak systolic velocity of thyroid superior artery is detected. Thyrotoxicosis is defined as TSH level below the low value of normal range. Graves disease is defined as the typical symptoms of graves disease such as graves ophthalmopathy or increased iodine uptake. Thyroiditis is defined as lack of typical symptoms of graves disease or decreased iodine uptake.We use receiver operator curve(ROC) to evaluate its diagnosis value
Inclusion criteria: inclusion criteria:

 newly diagnosed without taking any antithyroid drug or beta receptor blocker with TSH level below the lower limits of reference range

 is willing to be enrolled

Exclusion criteria: :

 unwilling

 taking antithyroid drug or beta receptor blocker

 taking foods or medicine rich in iodine in 8 weeks

 women with pregnant or lactation

['Thyrotoxicosis', 'Peak Systolic Velocity of Superior Thyroid Artery', 'Thyroiditis', 'Graves Disease']


Young Onset Dementia - the Difficult Diagnosis and the Stressful Life for the Whole Family

Summary: People diagnosed with young onset dementia are today mostly assigned to the same healthcare services as people developing dementia at an older age. They and their families are however in a quite different life situation, which is likely to generate different challenges and specific needs for tailored healthcare services, of importance in maintaining their perceived quality of life.~The investigators of this study wish to assess the factors influencing these families' quality of life, their specific needs and their use of healthcare services by the use a combination of quantitative and qualitative methods. The main aim of this study is to provide better future healthcare services to these families, and to develop a programme for optimal collaboration between specialist healthcare services and the local dementia teams.
Inclusion criteria: inclusion criteria:

 Debut of dementia symptoms before the age of 65 years, but age at time of inclusion may be up to 70 years.

 FTD (Neary et al 1998 criteria)

 Primary progressive aphasia (Mesulam 2003 criteria)

 AD (DSM-IV)

 Community living, excl. dementia-specific living facilities manned 24/7

 Family member with regular contact at least x 1/week.

Exclusion criteria: :

 Lack of informed consent

 No close or appropriate family member

 Frontal lobe dysfunction due to non-progressive injury, i.e. cerebral infarction

 Frontal lobe dysfunction due to motor neuron disease (ALS)

 Other dementia specific condition with frontal lobe dysfunction (Huntington, HIV, Down syndrome, alcoholic dementia)

 Mental retardation

 Current substance abuse, incl. excessive alcohol consumption for the past 12 months

['Frontotemporal Dementia', 'Alzheimer Disease']

Frontotemporal Dementia
Alzheimer Disease


Investigation of Southern Tick-Associated Rash Illness (STARI)

Summary: This study will evaluate blood and tissue samples for a condition called Southern Tick-Associated Rash Illness (STARI). This is a skin rash resembling erythema migrans, the rash found in people infected with Lyme disease. In the south and southeastern United States, STARI is associated with the bite of the lone star tick. Researchers seek a better understanding of the cause of STARI. Through researchers' knowledge, diagnostic tests could be developed. NIH is conducting this study along with the Centers for Disease Control and Prevention (CDC).~Patients ages 14 years and older who have recently been diagnosed with possible STARI, who have not taken antibiotics for it longer than 1 day, and whose skin does not form large scars may be eligible for this study. About 20 participants will be enrolled over a 5-year period. Patients will visit the NIH Clinical Center for two or three visits. The first visit may last 2 hours. Photographs will be taken of the rash, and a blood sample of about 1-1/2 tablespoons will be collected for tests. Patients will undergo a punch biopsy of three small pieces of skin, from the rash. The area of the skin will be cleaned, and patients will receive a local anesthetic at the biopsy site. A sharp instrument will remove a round plug of skin, about the size of half a pencil eraser. Patients may feel a pushing sensation, but there should not be pain. The site usually heals without sutures, though the doctors may close it with special adhesive bandages or one or two sutures. Patients will receive instructions about how to take care of the biopsy site. If sutures are used, patients will return in 7 to 10 days to have them removed-or a patient's own doctor may remove the sutures. Patients will return to NIH at 4 to 6 weeks following their first visit. At that time, they will answer questions about how they are doing and donate about 2 tablespoons of blood. Blood and skin samples will be used for research at NIH and CDC.~...
Inclusion criteria: inclusion criteria:

 Enrolled in protocol 02-I-0055.

 A person who is at least 14 years old.

 Acute onset (within 14 days of visit to NIH) of an annular, erythematous, expanding erythema migrans (EM)-like rash that attains a size of at least 5 cm in diameter, when no alternative explanation for the rash can be found, and thought by the study physician to have a high likelihood to be due to STARI (due to exposure history, tick identification).

 History of tick bite at the rash site, or potential exposure to ticks in the southeastern and south central United States within 14 days prior to rash onset (including Maryland and Virginia).

 Consent to storage of biologic samples for later testing.

Exclusion criteria: :

 A person who, in the judgment of the investigator, would be at increased risk from the skin biopsy procedure and unlikely to be able to mount a serological response to the agent (for example, bone marrow transplant, B cell deficiency).

 EXCLUSION FROM SKIN BIOPSY PORTION OF STUDY:

 A person who meets the case definition but whose EM-like rash occurs on the face, neck, scalp, or over the tibia will not be enrolled for purposes of obtaining a skin biopsy specimen. Such a person may enroll for purposes of providing a clinical history and blood samples only. This exclusion also applies to patients with a history of forming large thick scars after skin injuries or surgery, or who have a history of excessive bleeding after cuts or procedures or are taking anticoagulants, or have severe skin disease. Also, patients who have received more than 24 hours of antibiotic treatment for the rash will be excluded from the biopsy. Patient with a history of allergy to lidocaine will also be excluded from the biopsy portion of the study.

['Southern Tick-Associated Rash Illness']


Multicenter Registry for Comparative Effectiveness Analysis of Venous Thromboembolism in Trauma Patients

Summary: Venous thromboembolism (VTE) remains a leading cause of death in trauma patients. Based on the EAST Management Guidelines for the prevention of VTE in trauma patients, a number of research questions could be addressed by a thorough current literature review combined with a multicenter concurrent analysis. This proposal seeks to create a data registry of trauma patients from multiple trauma centers around the United States that will serve as a platform for the study of VTE.
Inclusion criteria: inclusion criteria:

 Admitted to the hospital for care of injuries

 Have a greater than minimal (moderate to highest) level of VTE risk

Exclusion criteria: :

 Discharged prior to 24 hours in hospital

 Minimal VTE risk

['Venous Thromboembolism', 'Pulmonary Embolus', 'Deep Vein Thrombosis']

Venous Thromboembolism
Pulmonary Embolus
Deep Vein Thrombosis


The Quietude Study: Quetiapine Use for Agitated Depression

Summary: Most individuals with major depressive disorder manifest clinically significant agitation. Concurrent agitation in a depressed individual is associated with an intensification of mood symptoms, decreased probability of recovery, increased recurrence risk, suicidality, and increased medical-service utilization. The occurrence of anxiety/agitation phenomenology in the depressed patient often invites the need for augmentation strategies (e.g. atypical antipsychotics, benzodiazepines, etc.) and complicated polypharmacy regimens. Moreover, individuals with major depressive disorder often report worsening of symptom severity, irritability, hostility, dysphoria, and significant subjective distress (This response pattern is similar to individuals with bipolar disorder).~Results from large research studies provide evidence indicating that quetiapine is capable of offering clinically significant multidimensional symptom relief in bipolar depression. Moreover, results from several trials in major depressive disorder and generalized anxiety disorder have established the efficacy of quetiapine therapy for unipolar depression and anxiety syndromes. So far, no atypical antipsychotic agent has been evaluated specifically for the treatment of agitated depression.~In this study, it is hypothesized that persons with major depressive disorder and prominent agitation (i.e. agitated depression) will exhibit a more favourable response and tolerability profile to quetiapine XR when compared to escitalopram.
Inclusion criteria: inclusion criteria:

 Male or female

 Age 18 to 65

 Outpatient at enrolment

 A diagnosis of major depressive disorder

 Baseline HAMD-17 score > 20 and HAMD Item1 score > 2 both at enrolment and baseline

 Significant agitation

 CGI-S score > 4 at screening and baseline

 Negative serum pregnancy test at enrolment and use of a reliable method of birth control during the study

 Able to understand and comply with the requirements of the study

 Able and willing to give meaningful informed written consent

Exclusion criteria: :

 Another Axis I diagnosis of primary focus within 6 months of enrolment

 Axis II disorder causing impact on current diagnosis

 Current depressive episode <4 weeks, or >12 months

 Substance or alcohol abuse or dependency as defined by DSM IV within 6 months of enrolment

 Any pervasive developmental disorder or dementing disorder

 Treatment with other antipsychotics, mood stabilizer or other psychoactive drugs less than 7 days prior to randomization

 Treatment with fluoxetine less than 28 days prior to baseline

 Treatment with MAO inhibitors, anxiolytic drugs in excess of 2 mg lorazepam equivalents/day.

 Insufficient response to more than two antidepressants during the index episode prior to study involvement

 Known lack of antidepressant response to quetiapine at a dose of at least 50 mg/day x 4 weeks

 Known lack of antidepressant response to escitalopram at a dose of at least 10 mg/day

 Known intolerance or hypersensitivity to quetiapine or escitalopram

 Treatment with Electroconvulsive therapy within 90 days prior to baseline

 Use of Potent P450 3A4 inhibitors or inducers within 14 days of baseline

 AST & ALT ≥ 3X ULN

 TSH ≥ 10% ULN

 Unstable medical condition

 Medical condition the would affect absorption, distribution, metabolism or excretion of study treatment

 Significant ECG abnormalities

 Pregnancy or lactation

 Patients with increased suicidal risks, HAM-D item 3 ≥3 or have made a suicide attempt within the past 6 months.

 Patients who, in the investigators opinion, will require psychotherapy (other than supportive psychotherapy) during the study period, unless psychotherapy has been ongoing for a minimum of 3 months prior to randomisation

 A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:

 Unstable DM defined as enrolment glycosylated haemoglobin (HbA1c) >8.5%.

 Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.

 Not under physician care for DM.

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

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

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

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

 Clinically significant deviation from the reference range in clinical laboratory test results

 An absolute neutrophil count (ANC) of 1.5 x 109 per liter

 Those who are involved in the planning and/or conduct of the study cannot be enrolled as subjects

 Previous enrolment or randomization in the present study

 Participation in another medication trial within 4 weeks prior to enrolment into the study herein


Surveillance of Streptococcal Infections in Children in India

Summary: Information from this study is needed to plan an eventual trial of a GAS vaccine in India if and when one is available. A GAS vaccine is currently a priority of the Indian Council for Medical Research (ICMR), and this project has been approved by the Joint Working Group (US and Indian Delegates) of the Vaccine Action Program, a joint effort of the ICMR and NIAID to implement cooperative efforts between the two countries on mutual objectives in vaccine development. Currently, several GAS vaccines are in development, supported by NIAID, and other sources, and one candidate is in phase one clinical trial authorized by the FDA. Information on the antigenic structure of GAS isolated in India will be needed for planning vaccine composition. It is the view of the Indian Ministry of Health and Indian Council for Medical Research that eventual prevention and control of rheumatic fever and rheumatic heart disease in India, now a heavy burden on the children will require a GAS vaccine, which requires both access to primary health care and a vaccine if and when it is available.~Information on incidence is needed to determine the size of a future vaccine cohort in order to obtain a statistically significant result on vaccine efficacy. Although unrelated to vaccine development, information on the incidence of GAS pharyngitis is needed in India to implement primary and secondary acute rheumatic fever (ARF) and rheumatic heart disease (RHD) prevention programs as were implemented in the USA and Europe forty years ago.~A vaccine trial is not part of this study, nor is there any intervention, other than antibiotic treatment of all children volunteers who develop GAS pharyngitis or impetigo.~An additional point should be made about the importance of obtaining epidemiological data on streptococcal disease in India, and on the emm types of GAS that cause infections. The population of India is over one billion people, representing nearly twenty five percent of the world's population. Information on GAS epidemiology from India is scant to say the least, and it is sorely needed. We now know that streptococcal toxic shock syndrome and fasciitis that have occurred in the U. S., Europe, Australia, and Japan, with greater frequency in recent years are caused by several genetically similar emm types of GAS. The implication of such genetic and epidemiologic data is that these genetically related strains have spread worldwide, Current information from India is far too limited to know if these virulent strains of GAS occur in India, and if they do, to what extent might they be the cause of frequent invasive disease in hospitalized patients.~Equally important, we do not know if a potentially high virulent GAS strain is currently emerging in some locale(s) in India, and what possible threat it might become, if it were to be transported to other worldwide geographic regions. Although not a specific aim of this proposal, the surveillance conducted to accomplish the aims of this protocol will provide essential information on the possible emergence of an unexpected emm type with pathogenic potential.~...
Inclusion criteria: inclusion criteria:

 All students (approximately 225-250) attending four classes in four rural schools, grades 2-5, in rural villages near Chandigarh, and all students in classes 2-6 approximately 225-250 attending one rural village school near Vellore were asked to participate.

 Approximately an equal number of boys and girls participated.

 Selection of the schools for the study was determined by such factors as the accessibility to a rural regional clinic, housing facilities for medical staff, and passable tertiary roads to the villages and the schools.

Exclusion criteria: :

 All volunteers had a history of acute rheumatic fever and acute glomerulonephritis and evidence of rheumatic fever and rheumatic heart disease on physical examination at the initial survey were excluded from the study.

 Excluded also was a child with a compromising illness such as cystic fibrosis that might require frequent or intermittent antibiotic treatment.

['Group A Beta Hemolytic Streptococcal (GAS) Infection']


The Chemopreventive Effect of Metformin in Patients With Familial Adenomatous Polyposis: Double Blinded Randomized Controlled Study

Summary: Familial adenomatous polyposis (FAP) leads to adenomas and eventual adenocarcinomas in colon and less frequently, duodenum. Chemopreventive strategies have been studied in FAP patients to delay the development of adenomas and cancers. The non-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase-2 inhibitor have shown the regression of colorectal and duodenal adenomas in FAP patients. However, these drugs showed gastrointestinal damage and cardiovascular risks, and new preventive strategies are needed. Metformin, a biguanide, which is widely used for treating diabetes mellitus, has recently been suggested to have a suppressive effect on tumorigenesis via mTOR-inhibiting pathway, and have no significant safety issues in long term use. The investigators devised a double-blind randomized controlled trial to evaluate the effect of metformin on polyps of colorectum and duodenum in non-diabetic FAP patients.
Inclusion criteria: inclusion criteria:

 Patients with familial adenomatous polyposis(FAP) who are 20 to 65 years of age.

 FAP patients who have colonic or duodenal polyp

 FAP patients who have five or more polyps 2mm or more in diameter in endoscopic examination.

Exclusion criteria: :

 FAP patients who had a history of colectomy within the previous 12 months or need to undergo colectomy within 8 months after randomization.

 FAP patients with malignant disease, including colorectal cancer.

 FAP patients who used NSAIDs (non-steroidal anti-inflammatory drugs) or aspirin three or more times a week within 6 months of randomization. 4. FAP patients with diabetes mellitus. 5. Pregnant or breast-feeding patients. 6. Patients with abnormal results of serum laboratory tests (renal function and liver function test) and significant infectious or respiratory diseases.


Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects

Summary: The purpose of this trial is to examine the safety and immunogenicity of Ty800 oral vaccine in healthy adult subjects.
Inclusion criteria: inclusion criteria:

 Healthy Males or Females aged 18 to 55 years, inclusive

 Capable of understanding and complying with the protocol requirements and be available for the duration of the protocol

Exclusion criteria: :

 History of malignancy, immunocompromised conditions or currently receiving immunosuppressive treatment including systemic steroids

 History of Typhoid Fever infection, vaccination against typhoid fever or participation in a Clinical Trial using S.typhi organism at any time

 History of travel to a typhoid endemic region within the last 5 years or history of raising a child from an endemic area. Endemic regions are South and East Asia, the Indian Subcontinent, Africa and Central and South America including Mexico

 History of persistent diarrhea, blood in stool, peptic ulcer disease, or inflammatory bowel disease

 Allergies or sensitivities to antibiotics, notably quinolones, penicillins, sulfonamides, cefalosporins and chloramphenicol, and components of the buffer solution, notably aspartame.

 People who are commercial food handlers, day care workers, or health care workers involved in direct patient care. Also people with young children under 2 years of age at home or household contacts who are immunocompromised, pregnant or breast-feeding

['Ty800 (Salmonella typhi) Oral Vaccine']


Influence of Tourniquet Use and Surgery Duration on the Incidence of Deep Vein Thrombosis in Total Knee Arthroplasty

Summary: This is an observational study to analyze the influence of surgery duration and tourniquet time in the incidence of deep venous thrombosis (DVT) in patients that had undergone total knee arthroplasty (TKA).
Inclusion criteria: inclusion criteria:

 patients that underwent cemented total knee arthroplasty

Exclusion criteria: :

 post-operative infection

 inadequate follow-up


Postoperative Analgesia After Total Hip Replacement

Summary: There are several treatments for postoperative pain after Hip Replacement Surgery. However, some require an intravenous line which may interfere with rehabilitation after surgery. This study aims to evaluate which method of pain treatment is best after Hip Replacement Surgery. Patients will either receive pain treatment at surgery, continuous intravenous pain treatment, or both. In the first two days after surgery, patients will frequently be asked to rate their pain, and use of other pain medication will be monitored.
Inclusion criteria: inclusion criteria:

 Patients accepted for fast-track total hip replacement, i.e.ASA 3 or lower

Exclusion criteria: :

 Not able to speak dutch

 communication problems

 dementia

 mental retardation

['Intrathecal morphine at surgery, 0.1mg and placebo', 'Patient Controlled Analgesia with iv morphine and placebo', 'intrathecal morphine AND patient controlled analgesia with iv morphine']


APTIMA HPV 16 18/45 Genotype Assay on the TIGRIS DTS System in Women With ASC-US or Negative Pap Test Results

Summary: In both the ASC-US Study and Adjunct Study populations, the objectives are to:~evaluate the performance characteristics of the AHPV-GT Assay for detecting cervical disease in women with APTIMA HPV Assay positive results and~evaluate the ability of the AHPV-GT Assay to detect HPV high-risk types 16, 18, and 45 in women with APTIMA HPV Assay positive results.
Inclusion criteria: inclusion criteria:

 • the subject attended a colposcopy visit, and

 the referral Pap sample had a valid APTIMA HPV Assay result, and

 the sample had an APTIMA HPV Assay positive result, or

 the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of cervical intraepithelial neoplasia (CIN) grade 2 [CIN2] or more severe (eg, CIN2, CIN grade 3 [CIN3], or cervical cancer; CIN2+), or

 the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of normal or CIN grade 1 (<CIN2) and was randomly selected for inclusion. the referral Pap sample had a valid APTIMA HPV Assay result, and

 the sample had an APTIMA HPV Assay positive result, or

 the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of CIN2+, or

 the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of <CIN2 and was randomly selected for inclusion.

Exclusion criteria: :

 Samples from evaluable subjects meeting the sample inclusion criteria will not be tested with the AHPV-GT Assay if there is insufficient volume for AHPV-GT Assay testing or the sample was deemed unsuitable for testing (eg, stored under unacceptable conditions).


COPDGene/Lung Cancer Center Database

Summary: The COPDGene® / Lung Cancer Database Study is a nested case-control study. This study is an ancillary study to COPDGene® Phase 1 and Phase 2. Lung cancer cases, which have been reported by COPDGene® subjects since the time of COPDGene® study enrollment, will be retrospectively verified with additional medical data collection pertaining to lung cancer. Additional 'control' subjects will also be identified and verified as a 'no lung cancer controls'. Data previously collected through the COPDGene® Study, including QCT results and clinical results (medication use, rate of acute exacerbations of COPD, etc) will be used as variables for analysis.
Inclusion criteria: inclusion criteria:

 Subjects must meet all of the following criteria

 Be enrolled in COPDGene® Phase 1 with or without enrollment in Phase 2 with newly diagnosed, (within the time of enrollment), non-small cell lung cancer (NSCLC) or small-cell lung cancer (SCLC).

 Documented GOLD stage 1-4 COPD or a history of smoking with no COPD

 Signed HIPAA Research Authorization and a Release of Protected Health Information form to collect and review medical records regarding lung cancer diagnosis, treatment, and outcome
Exclusion criteria:


Robot-assisted Rehabilitation of Hand by Paralysis of the Upper Limb After Stroke

Summary: The investigators evaluate the effectiveness of the application of continuous passive motion device for hand rehabilitation in two classes of patients: with a residual active motion and without a residual active motion.
Inclusion criteria: inclusion criteria:

 a history of acute phase of stroke (less than 12 months post onset),

 first stroke episode,

 no history of peripheral nerve injury or musculoskeletal disease in the affected upper extremity,

 no contracture of the affected wrist or fingers (Modified Ashworth<3),

 no history of any invasive procedure (Botulinum toxin type A) for the treatment of spasticity for at least 6 months before the start of this study,

 for P-ROM patients, the absence of active hand movements,

 for the A-ROM patients, the presence of active hand movements.

Exclusion criteria: :

 unstable medical disorders,

 active Complex Regional Pain Syndrome (CRPS),

 severe spatial neglect,

 aphasia,

 cognitive problems.

['A-ROM Continuous Passive Rehabilitation', 'P-ROM Continuous Passive Rehabilitation']

A-ROM Continuous Passive Rehabilitation
P-ROM Continuous Passive Rehabilitation


Voriconazole With or Without Interferon Gamma in Treating Patients With Aspergillosis or Other Fungal Infections

Summary: RATIONALE: Antifungals such as voriconazole may be effective in controlling fungal infections. Combining voriconazole with interferon gamma may be more effective than voriconazole alone in treating fungal infections.~PURPOSE: Randomized phase II trial to compare the effectiveness of voriconazole with or without interferon gamma in treating patients who have aspergillosis or other fungal infections.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Proven or probable invasive aspergillosis or other filamentous fungal infection by cytology, histopathology, or culture within the past 7 days

 Presenting with 1 of the following:

 Cancer

 Aplastic anemia

 Inherited immunodeficiencies

 Autoimmune deficiency disorders

 Acquired immunodeficiencies

 Recipient of autologous peripheral blood stem cell or bone marrow transplantation

 CNS aspergillosis or other filamentous fungal infection allowed

 No invasive zygomycosis infection

 PATIENT CHARACTERISTICS:

 Age

 2 and over

 Performance status

 Not specified

 Life expectancy

 At least 7 days

 Hematopoietic

 Not specified

 Hepatic

 ALT no greater than 5 times upper limit of normal

 Renal

 Creatinine clearance at least 30 mL/min

 Other

 Not pregnant or nursing

 Negative pregnancy test

 Fertile patients must use effective barrier contraception

 No prior significant CNS disorder (e.g., multiple sclerosis or uncontrolled seizures)

 No prior grade 3 or 4 toxicity or severe allergic reaction to interferon gamma

 No prior intolerance or hypersensitivity to voriconazole or other azoles

 No acute or chronic graft-versus-host disease

 No conditions that would preclude study compliance

 PRIOR CONCURRENT THERAPY:

 Biologic therapy

 See Disease Characteristics

 No prior allogeneic peripheral blood or bone marrow transplantation

 No concurrent interferon alfa

 Chemotherapy

 Not specified

 Endocrine therapy

 Not specified

 Radiotherapy

 Not specified

 Surgery

 No prior solid organ transplantation

 Other

 Prior voriconazole allowed

 At least 24 hours since prior administration of any of the following:

 Astemizole

 Cisapride

 Pimozide

 Quinidine

 Sirolimus

 Terfenadine

 Rifabutin

 Ergot alkaloids

 Sildenafil citrate

 Amiodarone

 Flecainide

 Systemic lidocaine

 More than 14 days since prior long-acting barbiturates, carbamazepine, or rifampin

 No other concurrent systemic antifungal drugs

 No other concurrent investigational agents
Exclusion criteria:

['recombinant interferon gamma', 'voriconazole']

recombinant interferon gamma
voriconazole

['Infection', 'Unspecified Adult Solid Tumor, Protocol Specific']

Infection
Unspecified Adult Solid Tumor
Protocol Specific


Immune Reconstitution in Tuberculosis Disease

Summary: The aim with study is to provide adjunctive therapy with vitamin D and phenylbutyrate together with standard anti-tuberculosis treatment to significantly improve clinical recovery among patients with untreated, active pulmonary tuberculosis.
Inclusion criteria: inclusion criteria:

 HIV negative patients, adult patients >18 years who has not started anti-TB therapy.

 Newly diagnosed pulmonary TB confirmed by microscopy or culture but also sputum-negative clinical TB cases (defined according to the WHO 2006 criteria for sputum smear-negative TB ie. clinical symptoms of TB, chest X-ray findings and response to standard treatment).

Exclusion criteria: :

 Patients who have already started treatment with anti-TB drugs for more that 5 days.

 HIV-positive patients.

 History of anti-TB treatment in the past 2 years.

 Local extra-pulmonary TB in the absence of lung manifestations.

 Hypercalcaemia (serum calcium > 3 mmol/L) identified at baseline.

 Pregnant and breast feeding women.

 Any known liver or kidney function abnormality, malignancy or patients treated with cardiac glycosides.

['vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)', 'Placebo tablets']


Pilot Study to Assess Flares Following Inactivated Influenza Vaccine in Children With Systemic Lupus Erythematosus (SLE)

Summary: This is an open label, pilot, observational, prospective study of the safety of inactivated influenza vaccine (IIV) in children with systemic lupus erythematosus (SLE) to be conducted during the 2013-2014 influenza season. The study will test conventional and novel biomarkers to assess disease flare and vaccine response and will also collect self-reported signs/symptoms in reactogenicity diaries during the 14 days after vaccination.
Inclusion criteria: inclusion criteria:

 inclusion criteria:

 Subjects who meet the following criteria will be allowed to participate in the study:

 Complete immunization history must be available at time of enrollment

 Patients will be aged 8-18 years at time of enrollment

 Patient will have stable disease activity (no changes in SLEDAI >2 points) during the 3 months preceding enrollment.

 Patients can be enrolled as soon as the seasonal IIV is available and prior to the onset of influenza activity in the community. Generally this will be between September 2013-January2014. If feasible, enrollment will end in December 2013, which is usually before influenza circulates widely in the community.

Exclusion criteria: :

 Subjects who meet the following criteria will not be allowed to participate in the study:

 Females who are known to be pregnant or breastfeeding

 Moderate to high SLE disease activity at enrollment (SLEDAI >6)

 Oral temp ≥100F (≥37.8) within 72 hours prior to vaccination

 History of allergy to egg or egg products or history of allergic reaction to previous influenza vaccination or vaccine constituent

 History of Guillain-Barré syndrome after previous immunizations

 Unstable SLE disease activity during 3 months prior to enrollment (change in SLEDAI score >2)

 Requirement for high-dose IV Solumedrol and/or Cytoxan pulse therapy during 6 months prior to study

 Any condition that study site investigator deems would put patient at unacceptable risk of injury or render patient unable to meet requirements of the protocol.

 Received pre-medication with analgesic or antipyretic agents in the 6 hours prior to first vaccination, or planned medication with analgesic or antipyretic in the week following first vaccination. This criterion should not preclude subjects receiving such medication if the need arises. However, pre-medication is to be discouraged.

 Patient has received other inactivated vaccines within 14 days prior to administration of IIV.

 Patient is scheduled to receive another routinely administered inactivated vaccine within 14 days after IIV.

 Patient is currently participating in a study that involves and experimental agent (vaccine, drug, biologic, device, blood product, or medication), or expects to receive another experimental agent during participation in this study

 -


Sleep Disordered Breathing in Precapillary Pulmonary Hypertension: Effect of CPAP Treatment

Summary: Evaluation of the effect of CPAP (continuous positive airway pressure ) treatment in PAH (pulmonary arterial hypertension) and CTEPH (chronic thromboembolic pulmonary hypertension) patients suffering from sleep disordered breathing.
Inclusion criteria: inclusion criteria:

 minimum 18 years old

 diagnosed with PAH or non-operable CTEPH or operated CTEPH with peristent pulmonary hypertension

 diagnosis of PAH based on cardiac catherisation

 diagnosis of CTEPH confirmed by contrast-enhanced spiral chest CT, pulmonary angiography and V/Q scintigraphy

 recent diagnosis of sleep disordered breathing (polysomnography realized within 3 months before inclusion showing AHI above 15) stable clinical condition for at least 3 months before inclusion as defined by NYHA and a walking distance difference within 10% of the previous 3 months and no change in medical therapy during this 3 months

Exclusion criteria: :

 congenital heart disease

 moderate and severe restrictive or obstructive pulmonary disease with a TLC and a FEV1<60% of the predicted value

 BMI 35kg/m2 or more

 patients already treated with CPAP

 patients with severe sleepiness (epworth sleepiness scale from 18 to 24/24)

['Sleep-Disordered Breathing', 'Pulmonary Arterial Hypertension', 'Chronic Thromboembolic Pulmonary Hypertension']


Way to Safety Cellphone Blocking

Summary: Research participants will be recruited to take part in a randomized control trial. Participants' cellphone use will be observed during an initial baseline period. Participants will then be randomly assigned to one of four conditions: education only (control), opt-in blocking, opt-out blocking, and opt-out blocking with parental notification.
Inclusion criteria: inclusion criteria:

 High school student

 16 or 17 at start of the study

 Have a valid driver's license

 Lives in parent's/guardian's home

 Drives to school

 Primarily drive one car

 Has their own iPhone 4S or newer or Android 4.3 or newer smartphone with data plan

 Parent/guardian is willing to assist with installation

 Admit to texting while driving >1 time in the last 30 days

Exclusion criteria: :

 1. Already uses a smartphone app or hardware device to limit cellphone use while driving

['Cellcontrol DriveID', 'Education Only']

['Teen Drivers', 'Motor Vehicle Accident']


Memantine in Systemic Lupus Erythematosus

Summary: Neuropsychiatric manifestations of Systemic Lupus Erythematosus (NPSLE) are both common and an important source of morbidity. Of the case definitions for NPSLE syndromes that have recently been developed, cognitive dysfunction appears to be the most prevalent. A novel mechanism is that a subset of SLE patients with cognitive dysfunction have antibodies in the NR2 glutamate receptor. We propose, in a double -blind placebo-controlled trial, to determine whether SLE patients, with or without the NR2 glutamate receptor antibody, have significant improvement using memantine, an inhibitor of the NMDA receptor.
Inclusion criteria: inclusion criteria:

 Clinical diagnosis of SLE

 Self-reported cognitive impairment

Exclusion criteria: :

 Age < 18 years.

 History of non-compliance

 Pregnancy

 Liver or renal insufficiency/failure (calculated creatinine clearance < 50 cc/min)

 Severe SLE flare in the last 6 weeks (defined as SLEDAI > 12 points)

 Recent (within 4 weeks) change in any medication relevant to cognitive function, including prednisone, anti-depressants, medications for insomnia, narcotic medications, attention deficit disorder medications

 Current alcohol or illicit drug abuse

 Current use of Namenda, Aricept, Provigil


Lithium Cannabis Withdrawal Study

Summary: This trial will examine the efficacy of lithium in providing symptomatic relief from the withdrawal discomfort experienced by some dependent users of cannabis on cessation of regular use. Significant withdrawal may be a barrier to achieving abstinence in some clients and can be associated with marked disturbances in mood, sleep, hostility and aggression. Relief from such symptoms may be important in helping some clients achieve a period of abstinence and facilitate subsequent entry into a relapse prevention program.
Inclusion criteria: inclusion criteria:

 DSM-IV diagnosis of cannabis dependence with at least a three-month history.

 Seeking treatment for primary cannabis problem

 Withdrawal identified as barrier to abstinence

Exclusion criteria: :

 Other drug dependency (excluding nicotine)

 Client is breastfeeding or pregnant.

 Client has contraindicated medical or psychiatric conditions.

 Client currently taking other medications that may interact with lithium.

 Known hypersensitivity / side effects with Lithium.

 Currently receiving Lithium from another source.

 Currently prescribed any antidepressant / mood stabilising / antipsychotic medication.

 Currently receiving opioid pharmacotherapy.

['Cannabis Dependence', 'Substance Withdrawal Syndrome']

Cannabis Dependence
Substance Withdrawal Syndrome


Effects of Losartan on Insulin Resistance in Patients With Heart Failure

Summary: The purpose of this study is to evaluate the effects of losartan, an ARB, on glucose metabolism and inflammatory cytokines in CHF patients treated with ACE inhibitors.
Inclusion criteria: inclusion criteria:

 chronic stable heart failure

Exclusion criteria: :

 renal dysfunction or under treatment with antidiabetic agents


Wrist Extension Dynasplint (WED) Distal Radius Fracture

Summary: The purpose of this study is to evaluate the effectiveness of a dynamic splinting system for wrist extension contracture following a distal radius fracture.
Inclusion criteria: inclusion criteria:

 Distal radius fracture treated with surgical management and wrist flexion contracture upon follow up

Exclusion criteria: :

 Carpal Fractures (Scaphoid, Lunate, Hamate, and Trapezium)

 Radial nerve entrapment

 Arthrodesis

 Traumatic dislocation of the distal ulna

['Distal Radius Fracture', 'Wrist Contracture']

Distal Radius Fracture
Wrist Contracture


Determining Age Appropriateness of Children's Products and Toys: An Interagency Agreement With the Consumer Product Safety Commission

Summary: Background:~Play during childhood is an important part of healthy development, and children can learn many things when they play. Much of the time that children spend playing is with toys. However, children at different ages need different types of toys to engage in healthy play.~Understanding children s play with toys is important to the National Institute of Child Health and Human Development (NICHD), and to the U.S. Consumer Product Safety Commission (CPSC). The CPSC rates toys that are currently available in the United States for children for age appropriateness. NICHD will share the findings of this study with CPSC to aid in their toy rating process.~Objective:~To categorize traditional and contemporary children s products and toys into age appropriate groups.~Eligibility:~Healthy children 6 months to 12 years old.~Their parents.~Design:~Participants will be screened with a phone call with the parents.~Participants will complete surveys online or on paper, and by phone. These will ask about demographic facts, behavior, thoughts on parenting and toys, and child development.~Participants will have 1 study visit. The child will play with toys by himself or herself. Then they will play with their parent. A researcher will observe. The sessions will be videotaped.~Children will share their thoughts about the toys by pointing at a smiley face scale.~Parents will fill out a short survey. Then can choose to participate in a 1-hour focus group.
Inclusion criteria: inclusion criteria:

 All children between the ages of 6 months to 12 years of age who are typically developing and born of a full term pregnancy if under 24 months of age, healthy, and English speaking are eligible for inclusion in the study. Typically developing children would not have any diagnosed congenital conditions, developmental delay or disability, dyslexia, PDD, ADD, ADHD, or ASD. In addition, we will only enroll subjects if they are from a racial and ethnic group that is still needed to ensure the diversity and representative nature of our sample as set forth in the Planned Enrollment Form. These are the initial screening criteria that will be used.

Exclusion criteria: :

 Children outside of the 6 month-12 year age range: These years cover early life and are the ages of interest for children s play and are of central significance to the Consumer Product Safety Commission s goals.

 Families not fluent in English: Fluency in English is essential for parents to be able to fill out surveys. Families also need to be fluent in English so that they can comprehend verbal directions given by the experimenter during the testing session. If we included people who were not fluent in English, we would need many additional staff members who speak the multitude of languages of the diverse population of the Washington, D.C metro area to work with participants during the testing session and code the videos after the testing session is complete.

 Children who are sick, not typically developing, born premature (if they are under 24 months of age), blind, or deaf: We must recruit a healthy sample of typically developing children born in a full term pregnancy (if they are under 24 months of age) who are not blind or deaf for this project to remove any potential confounds that atypical conditions may have on children s play. Typically developing children would not have any diagnosed congenital conditions, developmental delay or disability, dyslexia, PDD, ADD, ADHD, or ASD. Including other populations such as deaf or blind children would require a different experimental set up, stimulus toys, and resources (i.e., someone who could convert our surveys to American Sign Language or Braille and could code the videos for the parent child behaviors during those sessions).

 Children who are not adding to the ethnic and racial diversity of the sample: The goal of our study is to recruit a sample of subjects who are racially and ethnically diverse. By making this diverse sample a priority, we hope that our results will be applicable to the diverse populations residing within the United States. To keep with this goal of a diverse and representative sample of children, we may have to exclude some families if we have already reached the quota of families from that particular racial or ethnic group.


Predictor for an Additional Benefit of Inhaled Corticosteroid in Patients Treated With Tiotropium for COPD

Summary: Study purpose is to evaluate if subjects with chronic obstructive pulmonary disease (COPD) are more likely to be responsive to additional inhaled corticosteroids if they have a positive response to hyperosmolar challenge with mannitol than if their response is negative.
Inclusion criteria: inclusion criteria:

 FEV1/FVC < 70%

 FEV1 % predicted > 60%

Exclusion criteria: :

 Other major disease

 Asthma

 Currently taking inhaled corticosteroids

 oral corticosteroids in the last 3 month

 significant cardiovascular disease

 pregnancy/breast feeding

 current use of salmeterol or other long acting bronchodilator


Study in Healthy Volunteers to Evaluate a Human Monoclonal Antibody Against Hepatitis C

Summary: This is a phase I, open-label, dose escalation study to evaluate the safety of MBL-HCV1 in healthy adult volunteers. Eligible volunteers will be admitted to a phase 1 unit for study infusion. A single dose of human monoclonal antibody will be administered. The study duration is 56 days. During this time, safety will be assessed via physical examinations, laboratory testing, concomitant medication usage and review of treatment emergent adverse events should they occur. Pharmacokinetics will be derived from analysis of blood samples obtained during the 56 day study.
Inclusion criteria: inclusion criteria:

 Study subject must have read, understood and provided written informed consent and HIPAA authorization after the nature of the study has been fully explained.

 Be > or equal to 18 years of age and < or equal to 55 years of age.

 Be in general good health without history of any of the conditions listed in
Exclusion criteria: .

 No use of any tobacco products for at least 6 months.

 A woman must agree not to become pregnant from the time of study enrollment until at least 3 months after the completion of the monoclonal antibody infusion. If a woman is sexually active and has no history of hysterectomy or tubal ligation, she must agree to use hormonal or barrier birth control with spermicidal gel.

 Sexually active male subjects must use a barrier method of contraception during the course of the study.

 Screening laboratory values must meet the following criteria:

 WBC (>3,900 - <11,000/mm^3)

 Platelets(>100,000/mm^3)

 Hemoglobin (>10.5 gm/dl)

 Creatinine (<1.1 x ULN)

 BUN (<1.25 x ULN)

 AST(<1.1 x ULN)

 ALT (<1.1 x ULN)

 Alkaline Phosphatase (<1.1 x ULN)

 Bilirubin (<1.1 x ULN)

 Glucose-nonfasting (>/=60 mg/dl and </=115 mg/dl)


Prospective Aerobic Reconditioning Intervention Study

Summary: The purpose of this study is :~To determine if aerobic exercise conditioning can improve symptoms, cardiovascular function and quality of life in elderly patients with congestive heart failure.~To describe the baseline clinical characteristics, cardiovascular function and neurohumoral function in elderly patients with congestive heart failure.~To determine the specific cardiovascular and noncardiovascular mechanisms by which symptoms and quality of life may improve following exercise conditioning in elderly patients with congestive heart failure.
Inclusion criteria: inclusion criteria:

 Age greater than or equal to 60 years of age

 Symptoms of congestive heart failure

 Able to understand and give informed consent

Exclusion criteria: :

 Age <60 years

 Does not have CHF

 Significant change in cardiac medication <3 weeks

 Myocardial infarction <3 weeks

 CABG surgery <3 months

 Angina pectoris not controlled during daily activity by pharmacological therapy or at <4 METS activity

 Sustained hypertension with systolic> 190 and diastolic> 110 on medications

 Valvular heart disease as the primary etiology of CHF

 Significant aortic stenosis

 Stroke of <3 months or with any physical restriction impairment that would prevent participation in exercise programs

 Chronic obstructive pulmonary disease on therapy that limits exercise duration

 Uncontrolled diabetes mellitus

 Active treatment for cancer or other noncardiovascular conditions with life expectancy less than three years

 Anemia 10 gms Hb)

 Renal insufficiency (cr >2.5 mg/dl)

 Psychiatric disease - uncontrolled major psychoses, depressions, dementia, or personality disorder

 Dementia - MMSE

 24 22 for

 8th grade education)

 Lack of an acoustic window sufficient to allow definition of endocardial borders on the screening echocardiogram.

 Plans to leave area or be admitted to a nursing home within 2 years.

 Inability to walk at least 420 feet in 6 minutes without a cane or other assistive device.

 Inability to exercise at or near home.

 At the discretion of the clinical staff, it is believed that the participant cannot or will not complete the protocol because of frailty, illness, or other reason.

 Participation in a regular exercise regimen more than one time per week for at least twenty minutes per session; including but not limited to walking, swimming, weight lifting, golfing, or taking an exercise class.

 Inability to ambulate without cane or other assistive device during biomechanics testing or treadmill.

 Inability to attend at least fourteen weeks of the facility-based intervention


Dexamethasone to Treat Acute Chest Syndrome in People With Sickle Cell Disease

Summary: People with sickle cell disease (SCD) may develop acute chest syndrome (ACS), which is a common and serious lung condition that usually requires hospitalization. Dexamethasone is a medication that may decrease hospitalization time for people with ACS, but it may also bring about new sickle cell pain. This study will evaluate the effectiveness of a dexamethasone regimen that includes a gradual dose reduction at decreasing hospitalization and recovery time in people with SCD and ACS.
Inclusion criteria: inclusion criteria:

 Diagnosis of sickle cell anemia (Hgb SS) or sickle-β0-thalassemia (Hgb Sβ0)

 Current episode of ACS, defined as a new lobar or segmental pulmonary infiltrate seen on a chest radiograph and two or more of the following findings:

 Temperature of 38.5°C or higher

 Tachypnea (i.e., rapid breathing)

 Dyspnea or increased work of breathing

 Chest wall pain

 Oxygen saturation of less than 90% in room air by pulse oximetry

 Current episode of ACS diagnosed in the 24 hours prior to study entry

 Ability to take medication in capsule form

Exclusion criteria: :

 Prior participation in this study

 Diagnosed with any medical condition that will likely be worsened by corticosteroid therapy, including any of the following conditions:

 Diabetes mellitus

 High blood pressure

 Esophageal or gastrointestinal ulceration or bleeding

 Known avascular necrosis

 Diagnosis of ACS in the 6 months prior to study entry

 Treatment with oral or parenteral corticosteroid therapy for any reason in the 14 days prior to study entry

 Use of inhaled corticosteroids or systemic corticosteroids for respiratory illness in the 3 months prior to study entry

 Long-term lung condition that requires treatment with corticosteroids

 Participation in a program of chronic transfusions that ended fewer than 4 months ago. A program of chronic transfusions includes a regimen of serial simple or exchange transfusions given at least every 6 weeks for at least three consecutive transfusions for the prevention of SCD-related complications.

 Pregnant

 Treatment with any investigational drug in the 90 days prior to study entry

 History of either tuberculosis or a positive skin test for tuberculosis

 Known HIV infection or a current systemic fungal infection


Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster

Summary: Distal radius fractures with dorsal dislocation among patients 70 years or older are randomized to conservative treatment with plaster or internal fixation with a volar plate. Thereafter they are followed at 2 weeks, 5 weeks, 3 months and 12 months with x-ray, functional scores and clinical examination.~An additional follow up at three years with X-ray, functional scores and clinical outcome will be conducted after a new written consent of continued participation in the study.~A health economy analysis will be preformed at 1, and 3 years for the participants with complete EQ5D.
Inclusion criteria: inclusion criteria:

 Dorsally displaced, 20 degrees or from a plane perpendicular do the diaphyseal axis, fracture.

 Low energy injury

 Patient 70 years old or older

 72 hours or less since injury at time of diagnosis

 Patient registered in the Stockholm region

 Patient understands spoken and written swedish

Exclusion criteria: :

 Intraarticular displacement in radiocarpal joint of more than 1 mm

 Ulna fractured proximal to the base of the styloid process of ulna

 Earlier unilateral functional impairment of hand/wrist

 Injury to tendon, nerve or skin besides the fracture

 Rheumatoid arthritis or other severe systemic joint disease

 Severe psychiatric disorder, ongoing drug abuse or dementia (Pfeiffer score 5 points or less)

 Besides the wrist fracture also other big injuries, for example fracture of hip, shoulder or ankle

 Medical illness that makes general anesthesia impossible

['Volar plate', 'Synthes TCP volar plate']


Study of Morphine in Postoperative Infants to Allow Normal Ventilation

Summary: OBJECTIVES: I. Compare nonmechanically ventilated infants who receive morphine postoperatively as intermittent intravenous bolus doses or as a continuous intravenous infusion targeted to reach a steady-state concentration.~II. Assess ventilation (blood gases, continuous oximetry, and CO2 response curves) and analgesia (infant pain score) between the two treatment groups of infants.~III. Compare ventilation parameters (blood gases, CO2 response curves, and time to wean from assisted mechanical ventilation) in cyanotic and acyanotic infants after thoracotomies.
Inclusion criteria: PROTOCOL ENTRY CRITERIA:

 --Disease Characteristics--

 Infants scheduled for surgery with postoperative inpatient care

 Must be born after 35 weeks or more gestational age

 No prenatal opiate exposure

 Part I patients:

 Less than 12 months of age undergoing surgeries involving major thoracic, abdominal, or cardiac procedures

 No pneumonectomy, tracheal or bronchial stenosis reconstruction, diaphragmatic hernia repair, or surgeries resulting in high intraabdominal pressure (closure of large gastroschisis or omphalocele defects)

 No hepatic or renal transplantation

 Part II patients:

 Less than 3 months of age undergoing surgeries using a thoracotomy approach

 Cyanotic congenital heart disease having palliative systemic to pulmonary artery shunts created OR Thoracotomy for repair of acyanotic lesions (e.g., repairs of coarctation of the aorta, tracheoesophageal fistula repair, PDA ligation)

 --Patient Characteristics--

 Age: Part I: Less than 12 months Part II: Less than 3 months

 Hepatic: Normal hepatic function tests

 Renal: Normal renal function tests

 Pulmonary: No pulmonary disease causing baseline hypercarbia

 No pulmonary hypertension contraindicating use of 5% CO2 in rebreathing studies

 Other:

 No allergy to morphine

 No severe developmental delay that precludes analgesia scoring
Exclusion criteria:


Development of Intervention Model for Osteoporosis and Fall Prevention in Taiwan

Summary: Department of Chronic Disease and Health Promotion of World Health Organization listed eight classes of chronic disease which will be important globally in the future. And the sixth class is Chronic Rheumatic Condition, which includes rheumatic arthritis, osteoarthritis, osteoporosis, spinal disorders and severe limb trauma. Obviously the osteoporosis is a globally important health topic.~Osteoporosis draws more and more attention, because osteoporosis has various influences, for example, (1) psychologically impact which occurs frequently in many chronic diseases, such as depression will appear evidently in patients with osteoporosis (2) patients with osteoporosis often lose their social role (3) osteoporosis might induce pain and limitation of body function (4) osteoporosis increases greatly the possibility of fracture. Osteoporosis will induce adverse outcomes, such as the fall of life quality, the increase of morbidity and mortality, as well as the increased abuse of medical service. In this project, the investigators will set up the intervention model for prevention of osteoporosis as well as falls.~In this project, the investigators will recruit patients form outpatient services at WanFang Hospital. Through the collection of baseline data from questionnaire and bone density measurement, the investigators can clarify the risk of osteoporosis and falls in studied patients. By using double-blind randomized design, the patients will be collected to either one of intervention and control group. After eight weeks of intervention programs, the investigators will follow on both groups to understand the effect of this program and to increase the bone density of intervention group. The hospital or the Health center might take the outcome to be the reference of taking care the Osteoporosis.
Inclusion criteria: inclusion criteria:

 the risk of osteoporosis

 the risk of falls
Exclusion criteria:


Efficacy of Nebulized Beclomethasone Dipropionate (BDP) in the Treatment of Moderate Croup

Summary: Acute laryngotracheobronchitis, better known as croup, is one of the common respiratory complaints among children and the most common cause of airway obstruction in children aged six months to six years. Patients with croup are typically visited by physicians during two peak time periods throughout the year. The first one is in the autumn, usually as a result of parainfluenza virus, and the second peak occurs in early winter, a consequence of RSV. Croup affects males more commonly than females and affects children between the ages of 6 months to 6 years. The incidence of croup peaks in children at 2 years of age; croup in older children is uncommon, and recurrent episodes are frequently observed.~Croup symptoms are generally short-lived, with about 60% of children showing resolution of their barky cough within 48 h. However, a few children continue to have symptoms for up to 1 week. Although most children with croup recover without specific treatment, up to 15% require hospital admission, and, among those admitted, up to 5% may require intubation.~Nebulised adrenaline is effective but it has a short duration of action and potentially dangerous side effects, and it is therefore not recommended for use in the community in mild-moderate Croup.~Oral and intramuscular steroid treatment, when given in adequate doses in hospital, has been shown to be effective for moderate to severe croup in a number of trials and a meta analysis.~It has been suggested that nebulised administration is superior to the oral or intramuscular route of administration for a more rapid onset of action and fewer side-effects.~This study is aimed to demonstrate the effectiveness of nebulised steroid administration as beclomethasone dipropionate in croup patients compare to placebo.
Inclusion criteria: inclusion criteria:

 Written informed consent obtained by parents/legal representative prior to any study-related procedures.

 Male or female subject aged between 6 months and 3 years referring to ER with acute onset barky cough, stridor, hoarseness, and respiratory distress

 Children with a diagnosis of moderate croup (Westley score 3-8)

Exclusion criteria: :

 Symptoms or signs of any other cause of stridor;

 Previous acute angioneurotic oedema;

 Children with diagnosis of severe croup (Wesley score >8);

 History of congenital or acquired stridor, diagnosis of epiglottitis, chronic pulmonary disease, asthma, severe systemic disease, exposure to chickenpox virus within the previous 21 days, or known immune dysfunction;

 Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study;

 Treatment with oral or parenteral corticosteroids within the previous 2 weeks; Treatment with epinephrine for respiratory distress before enrollment;

 Previous visit to an emergency room department due to croup during this episode of the disease;

 Inability of the parent to understand the nature and scope of the study or the possible benefits or unwanted effects of the study treatments;

 Enrollment in another clinical trial in the previous 4 weeks or subject already admitted in this study

 Lack of a telephone at home;

['beclomethasone dipropionate suspension for nebulisation 800 mcg/2 ml', 'Placebo solution for nebulisation 2 ml']


Doppler or Amniocentesis to Predict Fetal Anemia

Summary: In pregnancies complicated by Rhesus disease, the mother has developed antibodies which cross the placenta and can cause anemia and death of the fetus. When the anemia is detected on time, the fetus can be saved by giving it blood transfusions during the pregnancy.~The standard test to predict whether the fetus needs a blood transfusion is examination of the amniotic fluid. To obtain this fluid a needle has to be inserted in the womb, which has a risk of preterm delivery, infection, and making the disease worse. This is called amniocentesis.~A new safe test, using Doppler ultrasound, has been developed to possibly replace the amniocentesis.~The aim of this study is to compare the new Doppler test with the standard amniocentesis. If the Doppler test is at least as good, this safe test may replace the amniocentesis in the management of pregnancies with Rhesus disease.
Inclusion criteria: inclusion criteria:

 Pregnant women with red cell alloimmunization associated with a risk of fetal anemia (D, E, c or Duffy (Fya )antibodies, alone or in combination with other antibodies)

 Gestational age between 12 and 34 weeks at study entry, viable fetus and accurate dating

 Maternal serum test-result, above the threshold at which the fetus is considered to be at risk of developing hemolytic anemia and thus a potential candidate for invasive testing.

Exclusion criteria: :

 Presence of Kell-antibodies

 Presence of fetal hydrops at first ultrasonographic examination

 Major fetal congenital or chromosomal anomalies

['Fetal Middle Cerebral Artery Doppler measurement']


Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder (Zip Ad)

Summary: Psychotropic-related weight gain is a common concern among patients with bipolar disorder (BD). This concern affects an individual's satisfaction with treatment and may lead to reduced adherence and illness relapse. Patient-focused care is attentive to patient concerns while at the same time utilizing evidence-based treatments. Ziprasidone is currently FDA approved for the maintenance treatment of BD. Ziprasidone may be associated with less weight gain compared to some alternative BD maintenance treatments. The proposed project will evaluate how switching to ziprasidone may affect patient adherence, drug attitudes, satisfaction with care and clinical outcomes (psychiatric symptoms, functional status, weight) among BD patients concerned with weight gain.
Inclusion criteria: inclusion criteria:

 Diagnosis of Type I or II BD for at least 6 months (confirmed with MINI)

 On maintenance evidence-based treatment for BD (lithium, antipsychotic, anticonvulsant)

 Have weight gain concerns that individual believes are related to BD medication treatment

 Sub-optimal adherence as measured by the Tablet Routines Questionnaire (TRQ) and which the patient feels is related to weight gain concerns. TRQ threshold will be defined as missing an average of 20% or more of all prescribed BD treatment in the last week or month or missing 20% or more of the offending agent in the last week or last month. This is consistent with methodologies in PIs previous BD adherence studies

Exclusion criteria: :

 Known resistance or intolerance to ziprasidone

 Medical contraindication to ziprasidone

 Individuals on ziprasidone immediately prior to study enrollment

 Prior or current treatment with clozapine

 Diagnosis of eating disorder

 Individuals whose sub-optimal adherence is related to inability to pay for BD medication treatment or inability to arrange transportation to BD treatment clinical visits

 Concurrent medical condition or psychiatric illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial

 Current substance dependence

 High risk of harm to self or others

 Female who is currently pregnant or breastfeeding

['Medication Adherence', 'Bipolar Disorder']