Use of PillCam ESO2 in Triaging Patients Present With Upper GIB

Summary: Background~Patients presented to hospital with coffee ground vomiting and black stool may not be actually having upper gastrointestinal bleeding (UGIB)~Hospital admission can be avoided if serious UGIB can be excluded~To date, the only useful tool to triage patient for hospital admission in UGIB is by using clinical score such as Rockall score or Blatchford score~These scores are cumbersome and only exclude the most benign cases, but they are not useful in differentiating those who needs intervention~In our pilot study, investigators found that capsule endoscopy can be used to identify patients with fresh blood and real coffee ground substance in the stomach and it is superior to nasogastric tube~Most of UGI lesions leading to bleeding can be diagnosed by capsule endoscopy~Objectives The current study is designed~to validate capsule endoscopy is an effective method in identifying patients with UGIB~to study whether the capsule endoscopy can reduce requirement of hospital admission in patients with suspected UGIB~to study if capsule endoscopy can help to identify patients with UGIB that may require urgent (within 24 hours) endoscopy and intervention~to study the cost-effectiveness of capsule endoscopy being used as a triaging tool in the management of UGIB~to compare the effectiveness of capsule endoscopy against Blatchford score in identifying patients with UGIB that may require endoscopic intervention.
Inclusion criteria: inclusion criteria:

 Individual aged ≥ 18 years presenting to the emergency department with acute, overt UGIB defined as coffee ground vomiting and/or melena

Exclusion criteria: :

 UGIB with hemodynamic shock (BP<90mmHg and pulse>120 per minutes) requiring urgent endoscopy,

 UGIB with fresh hematemesis requiring urgent endoscopy

 dysphagia, odynophagia, swallowing disorder, Zencker's diverticulum, suspected bowel obstruction or bowel perforation,

 prior bowel obstruction, gastroparesis or known gastric outlet obstruction, Crohn's disease, past GI tract surgery.

 presence of an electromedical device (pacemaker or internal cardiac defibrillator),

 altered mental status (e.g., hepatic encephalopathy) that would limit patient ability in swallowing the capsule, pregnancy and/or lactating, allergy to conscious sedation medications, allergy to Maxolon, unwillingness to swallow the capsule, patient expected to undergo Magnetic Resonance Imaging examination within 7 days of ingesting the capsule, patient on medications that may coat the upper GI tract such as antacids or sucralfate, or inability to provide written informed consent.

 Allergy to Maxolon

 Patients with known Esophageal Varices or Gastric Varices with or without prior bleeding episodes

 Known upper/ lower GI cancer (eg, cancer of esophagus, stomach, small bowel, colon) or hepatocellular carcinoma or pancreatic cancer


Peptic Ulcer Disease in Ischemic Heart Patients Taking Aspirin and Clopidogrel With or Without Proton Pump Inhibitor

Summary: Studies showed that combined use of clopidogrel and aspirin had a 25 % reduction of risk on myocardial infarction and stroke in patients who undergone percutaneous coronary intervention (PCI) when compared with use of aspirin alone. However, major GI bleeding rose in combined group than aspirin group. Use of proton pump inhibitor (PPI) which diminishes gastric acid secretion effectively reduces aspirin or clopidogrel associated ulcer or/and ulcer bleeding in general population and high risk patients. The investigator hypothesis is whether use of PPI can reduce ulcer and ulcer complication in patients taking both clopidogrel and aspirin.
Inclusion criteria: inclusion criteria:

 Patients are eligible if they have received PCI for their stenotic coronary arteries and taken both aspirin and clopidogrel.

 Patients who had a past history of PUD without complication, who have taken aspirin or clopidogrel before enrolling for their CV disease will be allowed to enroll.

Exclusion criteria: :

 Patients are excluded if they have New York Heart Association class IV heart failure, if they had contraindications to antithrombotic or antiplatelet therapy, if they have clinical severe thrombocytopenia (platelet count< 80000/mm3), if they have previous disabling, or hemorrhagic stroke or intracranial hemorrhage, if they have severe and unstable conditions in hepatic, renal, and pulmonary disease, if they have unstable and progressive malignancy, if they have epigastralgia or have a positive occult blood in stool, if they have current or recent PUD and take PPI or histamine receptor-2 antagonist without proving healed ulcer by scopy, if they have received a surgical intervention due to PUD complication (bleeding, perforation, obstruction) in the past, if they have received a GP IIb/IIIa inhibitor fewer than 3 days before randomization.

['lansoprazole', 'aluminum hydroxide 334 mg and Mg hydroxide 166 mg']


Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLE

Summary: Treating severe thrombocytopenia is a challenge in the management of systemic lupus erythematosus. Although rheumatologists have followed some rules in real practice,there is very few evidence to support the current treatment algorithm. The purpose of this study is to compare the complete remission rate and partial remission rate of cyclophosphamide and hydroxychloroquine for treating severe thrombocytopenia in Chinese SLE patients.
Inclusion criteria: inclusion criteria:

 Patients fulfilled the 1997 ACR modified or SLICC classification criteria of SLE；

 New onset thrombocytopenia: platelet count <30X109/L(by both routine test and citric acid anti-coagulated blood count test) within 3 months

Exclusion criteria: :

 Thrombocytopenia caused by other reasons, including drugs；

 Positive for active HAV(hepatitis A virus)/HBV(hepatitis B virus) infection

 Active HIV(human immunodeficiency virus) or HCV(hepatitis C virus) infection;

 Active HP(Helicopter pylori) infection;

 Severe liver and kidney dysfunction；

 Severe neuropsychiatric lupus；

 No response to high dose steroid and/or cyclophosphamide 1 month prior to study enrollment；

 Uncontrolled diabetes or hypertension before entry

 Active GI bleeding 3 months before entry

 Intolerant to HCQ in the past treatment history；

 Severe bone marrow suppression or liver damage caused by cyclophosphamide in the past history；

 Active infection , including bacteria, virus, fungi, mycobacteria

 Allergy to any of the study medications

 Confirmed TTP(thrombolic thrombocytopenic purpura)or CAPS(catastrophic anti-phosphilipid syndrome)

 Platelet count less than 20X109/L with active bleeding

 Myelodysplastic diseases

 Patients with heart and lung function impairment

 thiopurine S-methyltransferase (TPMT) gene positive -

['Hydroxychloroquine', 'Cyclophosphamide', 'Azathioprine', 'Methylprednisolone']

Hydroxychloroquine Cyclophosphamide Azathioprine Methylprednisolone


Theory-Based Interventions for Smoking and Obesity (Challenge) Trial

Summary: The purpose of this study is to examine a new theory for understanding the processes that govern behavior change by observing how people's beliefs and feelings about smoking cessation or weight loss change as they participate in smoking cessation or weight control programs. This study also seeks to improve the ability of treatment programs to help people maintain changes in their behavior.
Inclusion criteria: Eligibility criteria for the smoking cessation studies were: between 18 and 60 years old, a minimum 2-year history of smoking, a current level of smoking > 10 cigarettes per day, and agreement to participate in the study.

 Eligibility requirements for the weight loss studies were: between 18 and 60 years old, body mass index (weight/height2) > 27.0, 20 percent or more above desirable weight according to medical standards, and consent to participate.

 Smokers and overweight persons were excluded if currently being treated by a physician for a serious physical or psychological disorder (e.g., heart disease, cancer, depression). Women were excluded if currently pregnant, pregnant in the last 6 months, or intending to become pregnant in the next 18 months. People who were overweight and who also smoked were considered eligible for participation in either weight loss or smoking cessation programs. However, they received treatment only for the particular behavior problem targeted by the study they chose to participate in.
Exclusion criteria:

['smoking cessation program', 'weight control program']

smoking cessation program
weight control program


Medication, Weight Gain and GI Hormones

Summary: This is an 8 week study that compares two medications. One medication is olanzapine (5-20 mg daily) whereas the other medication is an orally disintegrating medication. Both medications are used to treat depressed bipolar patients. The main focus of this study is the comparison of these two medications on gastro-intestinal hormones and weight gain.
Inclusion criteria: inclusion criteria:

 A principal diagnosis of bipolar 1 or II disorder

 Ages 18-60

 Physically healthy

 Outpatient status

 Montgomery-Asberg Rating Scale (MADRS) Score greater than or equal to 15

 BMI 23-30

 Able and willing to give written informed consent

Exclusion criteria: :

 Prior history of diabetes (types I or II)

 BMI>30

 Non-fasting blood glucose >124

 Fasting blood glucose >125 or random blood glucose >200

 Presence of dyslipidemia (baseline total cholesterol >240, HDL<50, LDL>160, triglycerides >199)

 Current or past history of a non-affective psychotic disorder

 Alcohol or other substance abuse or dependence in the 6 months prior to the evaluation (except for caffeine)

 Current use of any nicotine products

 Schizoid, schizotypal, or borderline personality disorder

 Treatment with olanzapine in the prior 3 months or any history of non- response to or intolerance of olanzapine or the olanzapine-fluoxetine combination (SymbiaxTM)

 Suicide potential that, in the opinion of the investigator, precludes outpatient treatment or participation in a trial

 Participation of subjects in another drug trial within 30 days of evaluation

 The presence of any current medical condition judged by the investigator to potentially interfere with the study procedures or measures

 The likelihood of requiring hospitalization over the period of the study

 The presence of any clinically-significant laboratory abnormality as judged by the investigator

 Pregnancy or lactation

 History of seizure disorder, excluding febrile seizures of childhood

 Any disorder of taste or smell, including severe nasal allergies

 Any other condition which, in the investigator's judgment might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study

 Being unable to comprehend or follow the study procedures.

['orally-disintegrating olanzapine', 'regular olanzapine']

orally-disintegrating olanzapine
regular olanzapine


Colonography Versus Colonoscopy in High Risk Patient

Summary: to evaluate the acceptability of CT-colonography compared to colonoscopy for the detection of advanced adenomas in subpopulations at high risk of colorectal.
Inclusion criteria: inclusion criteria:

 Surveillance of patients with a personal history of advanced adenoma or CRC:

 Informed consent obtained

 Age ≥ 18 and ≤ 80 years old

 History of advanced adenomatous polyps

 Or history of non metastatic CRC with curative surgery and without other treatment more than 2 years before enrollment.

 Previous medical examination

 Screening of patients with a Family history of CRC at high risk:

 Informed consent obtained

 Age ≥ 18 and ≤ 80 years old

 First degree family history of colorectal cancer diagnosed <60yrs during the five previous years-Previous medical examination

Exclusion criteria: :

 Personal histories

 Age < 18 or >80 years old

 history of non adenomatous polyps

 history of Metastatic CRC

 familial adenomatous polyposis, Peutz-Jeghers syndrome, hereditary non polyposis colorectal cancer (HNPCC), juvenile polyposis syndrome

 Familial history of familial adenomatous polyposis

 Personal history of subtotal colectomy (but not of hemicolectomy, to confer to inclusion criteria)

 Colonoscopy with a polyps resection dated more than 5 years and less than 2 years prior to enrollment.

 Enrollment in another protocol

 no health insurance affiliation Family histories

 Age < 18 or >80 years old

 Patients with one or several family histories of first degree colorectal cancer occured to unknown age or diagnosed after 60 years old.

 Eligible patients having already undergone colonoscopy screening

 no health insurance affiliation


Sleep Apnea in Look AHEAD (Action for Health in Diabetes)

Summary: This study will assess the effects of weight loss on sleep-disordered breathing (SDB) in 120 obese, type 2 diabetics with obstructive sleep apnea (OSA) from four Look AHEAD sites. Changes in SDB will be compared between subjects randomized to weight loss (Lifestyle Intervention Group) versus non-weight loss (Diabetes Education and Support Group) conditions within the context of the Look AHEAD Study. Weight loss is frequently recommended for obese patients with OSA, but the empirical foundation for this recommendation is not well substantiated. Weight loss in obese apneics improves but does not eliminate SDB. Moreover, the degree of improvement is not correlated with the amount of weight loss. This study will assess SDB before treatment and at 1 and 2 years. We will also investigate clinical measures of fat distribution that may mediate the non-linear relationship between weight loss and improvements in SDB. Finally, we will examine the role of SDB in mediating changes in blood pressure associated with weight loss.
Inclusion criteria: inclusion criteria:

 Enrollment in LookAhead

 Type II Diabetes and Sleep Apnea

Exclusion criteria: :

 Determined by parent study, LookAhead

['Obstructive Sleep Apnea', 'Type 2 Diabetes']

:

 Determined by parent study, LookAhead


The Effects of Sound Energy on Pulmonary Gas Exchange

Summary: Study of the effects of sonic pressure oscillations on pulmonary gas exchange with added dead space.
Inclusion criteria: inclusion criteria:

 Healthy male or female volunteers in the age group.

Exclusion criteria: :

 Any acute or chronic cardiopulmonary disorder including a simple common cold.

['Induction of sound waves in lungs by sonic oscillator']


Intra-articular Hyaluronan After Arthroscopic Meniscal Surgery

Summary: The primary objective of this clinical investigation is to determine whether post-arthroscopic treatment with 10 ml of 0.5% sodium hyaluronate (VISCOSEAL® SYRINGE) can relief pain, improve mobility and promote joint recovery, compared to the standard arthroscopy procedure alone, in patients undergoing arthroscopic procedure.
Inclusion criteria: inclusion criteria:

 Male and female patients between 18 and 75 years of age.

 Good general health condition.

 Signed written informed consent.

 Patients with necessity for arthroscopic meniscal surgery.

 Ensured compliance of subject over the whole study period.

Exclusion criteria: :

 Concomitant or previous participation in a clinical investigation within the last 3 months prior to study inclusion.

 Knee joint arthroscopy in study relevant joint within 6 months prior to study inclusion.

 Patients with known hypersensitivity to the investigational device (i.e. active compound and excipients) or any component or procedure used in the study.

 Contraindication for the use of the investigational product or for the scheduled arthroscopy, used anesthesia and post-surgical treatment.

 Concomitant disease of sufficient severity (e.g. uncontrolled diabetes mellitus, carcinoma, etc.), which in the opinion of the investigator, may put the patient at risk when participating in the study, or affect the patient's ability to take part in the study.

 Concomitant disease of sufficient severity at study relevant joint (e.g. known or suspected infection, peripheral neuropathy or presence of hemarthros).

 List of concomitant medications not allowed which interfere with the functional assessments of this study.

 Use of medication contraindicated for arthroscopic surgery.

 Intra-articular treatment with a sodium hyaluronate-based product within the last 6 months or use of corticosteroid containing substance within the last 3 months at study relevant joint.

 Recent history of drug and/or alcohol abuse (within the last 6 months) or patients with severe mental illness or suicidal tendency.

 Pregnant or lactating females.

 Participants of childbearing age (pre-menopausal) who do not accept the use of methods of birth control with pearl index ≤ 1% (i.e. oral contraceptives, vaginal ring, hormone-releasing Intrauterine Device (IUD), implants, depot syringes, hormone patch, double barrier method, tubal ligation, vasectomised partner,…) during the treatment period and the first 4 weeks of follow-up period.

 Subjects having a high probability of non-compliance to the study procedures according to investigator's judgement (like illiteracy, insufficient knowledge of local language).

 Kellgren III-IV on study relevant side (confirmed by X-ray).

['Hyaluronan (0.5%, 5 mg/10 ml)', 'Standard arthroscopic meniscal surgery']

Hyaluronan (0.5%
5 mg/10 ml)
Standard arthroscopic meniscal surgery


Effects of Hormone Therapy on the Immune Systems of Postmenopausal Women With Chronic Infections

Summary: Hardening of the arteries (atherosclerosis) and heart disease are much more common in men than in women. However, as women grow older, especially after menopause the incidence of atherosclerosis and heart disease increases. These findings suggest that estrogen may be protective and help in preventing heart disease.~Studies of large groups of post-menopausal women suggest that hormone replacement therapy (therapy that includes estrogen) reduces the risk of heart disease. Estrogen causes favorable changes in particles that carry cholesterol in the blood stream and improves function of blood vessels. Estrogen may also stimulate the immune system's ability to fight off infections that may lead to or contribute to atherosclerosis.~Researchers believe two specific infectious agents (Chlamydia pneumoniae and human cytomegalovirus) may cause damage to the lining of blood vessels resulting in inflammation and the development of atherosclerosis.~The purpose of this study is to determine if estrogen treatment can change how the immune system responds to chronic infections, by Chlamydia pneumoniae and human cytomegalovirus, in postmenopausal women.
Inclusion criteria: Must be a postmenopausal woman 65 years of age or younger.

 Time since last date of menses should be at least 12 months, with plasma estradiol less than 50 pg/ml and FSH greater than 50 pg/ml.

 Women must be without clinical evidence of CAD as determined by history, cardiovascular physical examination, and EKG.

 Must not have used hormone replacement therapy within past 6 months.

 Must not have used dietary supplements and any medication (over-the-counter or prescribed) within 1 month. Acetaminophen use is allowed.

 Must not have a history of alcoholism or binge-drinking.

 Must not have diabetes mellitus or known abnormal glucose intolerance test.

 Must not have a history of stroke, angina or myocardial infarction.

 Must not have a history of deep venous thrombosis/pulmonary embolism.

 Must not have a history of cancer (except for treated squamous cell and basal cell carcinomas).

 Must not have evidence of liver disease (liver function enzymes greater than twice the upper limit of normal).

 Must not have impaired renal function (creatinine greater than 1.6 mg/dl).

 Must not have a diagnosis of an autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, thyroiditis, Raynaud's Disease).

 Must not have a history of intermittent vaginal bleeding.

 Must not have serum triglycerides greater than 400 mg/dL.
Exclusion criteria:

['Atherosclerosis', 'Chlamydia Infections', 'Cytomegalovirus Infections', 'Pneumonia, Bacterial', 'Postmenopause']

Atherosclerosis
Chlamydia Infections
Cytomegalovirus Infections
Pneumonia
Bacterial
Postmenopause


Efficacy of Low (30ml) Versus Full Dose (100ml) Contrast CT Pulmonary Angiography in Detecting Emboli

Summary: With the improvement in CT scanners and injectors, diagnostic chest CT can now be performed in less than 10 seconds. It was hypothesized that diagnostic CT pulmonary angiograms could be done with less than the usual 80-120 ml of contrast used. We have developed a method of performing diagnostic CT pulmonary angiograms with 30 ml of intravenous contrast in most patients. The long-term objective of this study is to show that there is no difference in the diagnostic efficacy of this low dose 30 ml technique when compared to the more traditional full-dose technique.
Inclusion criteria: inclusion criteria:

 Patients referred for CT pulmonary angiogram to exclude pulmonary embolus

Exclusion criteria: :

 Class 3 or 4 Congestive Heart Failure

 Supraventricular tachycardia

 History of contrast allergy

 Unable to give informed consent

 Patients with serum creatinine >1.28 mg/dl without referring physician approval

['Low-Dose IV Contrast', 'Siemens Sensation 64-MDCT scanner.', 'Visipaque 320 non-ionic isoosmolar contrast agent']


Perioperative Flare in RA: Characterization of Clinical and Biological Features

Summary: Researchers at the Hospital for Special Surgery are trying to learn more about post-operative rheumatoid arthritis flare (RA). This study hopes to understand RA flare after total joint replacement surgery and what the result of flaring is for patients over the 6 weeks post operation.~Through this study we aim to describe rates, characteristics, and risk factors of RA flare within 6 weeks of total hip arthroplasty (THA) and total knee arthroplasty (TKA)
Inclusion criteria: inclusion criteria:

 Age >18

 Patients with Rheumatoid Arthritis undergoing total joint replacement surgery

 Satisfy American College of Rheumatology(ACR)/European League Against Rheumatism(EULAR) 2010 classification criteria and/or the 1987 RA criteria (see below) and be diagnosed with RA

 For control subjects: Have OA(Osteoarthritis), SLE(Systemic lupus erythematosus) or other inflammatory arthritis.

Exclusion criteria: :

 Diagnosis of any other systemic rheumatic disease

 Diagnosis of or crystalline arthropathy.

 Unable to understand or read English.

 Unable to follow the study protocol in a reliable manner.

 Age < 18 or >75.

 EXPLANATION OF CRITERIA:

 Rheumatoid arthritis 1987 criteria:

 morning stiffness in and around joints lasting at least 1 hour before maximal improvement;

 soft tissue swelling (arthritis) of 3 or more joint areas observed by a physician;

 swelling (arthritis) of the proximal interphalangeal, metacarpophalangeal, or wrist joints;

 symmetric swelling (arthritis);

 rheumatoid nodules;

 the presence of rheumatoid factor; and

 radiographic erosions and/or periarticular osteopenia in hand and/or wrist joints.

 Criteria 1 through 4 must have been present for at least 6 weeks. Rheumatoid arthritis is defined by the presence of 4 or more criteria, and no further qualifications (classic, definite, or probable) or list of exclusions are required.

 ACR/EULAR 2010 criteria for the classification of RA:

 Table 3. The 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis

 Target population (Who should be tested?): Patients who

 have at least 1 joint with definite clinical synovitis (swelling)*

 with the synovitis not better explained by another disease

 Classification criteria for RA (score-based algorithm: add score of categories A-D;

 a score of ≥6/10 is needed for classification of a patient as having definite RA

 Score

 A. Joint involvement

 1 large joint 0

 2-10 large joints 1

 1-3 small joints (with or without involvement of large joints) 2

 4-10 small joints (with or without involvement of large joints) 3

 >10 joints (at least 1 small joint) 5

 B. Serology (at least 1 test result is needed for classification)

 Negative RF and negative ACPA 0

 Low-positive RF or low-positive ACPA 2

 High-positive RF or high-positive ACPA 3

 C. Acute-phase reactants (at least 1 test result is needed for classification)

 Normal CRP and normal ESR 0

 Abnormal CRP or abnormal ESR 1

 D. Duration of symptoms

 < 6 weeks 0

 6 weeks 1

 The criteria are aimed at classification of newly presenting patients. In addition, patients with erosive disease typical of rheumatoid arthritis (RA) with a history compatible with prior fulfillment of the 2010 criteria should be classified as having RA. Patients with longstanding disease, including those whose disease is inactive (with or without treatment) who, based on retrospectively available data, have previously fulfilled the 2010 criteria should be classified as having RA.


Study on the Prevalence of Human Papillomavirus Types in Women >= 15 Years of Age in the Kingdom of Saudi Arabia

Summary: This study aims to determine the prevalence of human papillomavirus (HPV) and to assess the HPV type distribution among women >= 15 years of age, attending routine gynaecological examination in the Kingdom of Saudi Arabia.
Inclusion criteria: inclusion criteria:

 Subjects/Subjects' parents or guardians, who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study,

 Women >=15 years of age attending a clinic for routine cervical screening,

 Written informed consent obtained from the subject and/or subject's parent/guardian.

Exclusion criteria: :

 Referral for abnormal cervical sample at the current visit,

 Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed,

 No cervical sample provided,

 History of hysterectomy,

 Known diagnosis of immunosuppression, or patient on immunosuppressives,

 Pregnant female >=25 years of age.

['Infections, Papillomavirus', 'Cervical Cancer']

Infections
Papillomavirus
Cervical Cancer


Effects of Dietary Pork and Egg on Appetite, Meal-patterning, and Weight Loss in Men

Summary: The purpose of this study is to identify how adult men respond to a weight loss diet that includes pork and eggs and increasing the number of meals consumed throughout the day. This is a 13-week study (12-weeks of weight loss and 1-week of baseline measurement).
Inclusion criteria: inclusion criteria:

 Age range: 21 years and older

 Body mass index between 25.0-39.9 kg/m2

 Weight stable (< 4.5 kg (

 10 lbs) weight gain or loss within last 6 months)

 Body fat >25% (assessed by skinfold and plethysmography (if needed))

 Non-smoking (within the last 6 months)

 Constant habitual activity patterns (within last 3 months)

 Clinically normal blood profiles (specifically, normal liver and kidney function; fasting blood glucose <110 mg/dl)

 Not taking medications known to influence appetite or metabolism

 Non-diabetic

Exclusion criteria: :

 Age: <21 years

 Body mass index: outside of the 25.0-39.9 kg/m2 range

 Gained or lost > 4.5 kg (10 lbs) within the last 6 months

 Body fat <25% as assessed by plethysmography

 Smoker (currently or within the last 6 months)

 Intermittently been involved in a diet and/or exercise program within the last 3 months

 Clinically abnormal blood profiles as identified by our study physician, Arthur Rosen, MD

 Taking medications (currently or within the last 3 months) known to influence appetite or metabolism

 Clinically diagnosed as diabetic

 Allergies to eggs

 Lactose intolerance

 Clinically diagnosed with diverticulosis

 Clinically diagnosed with diverticulitis

['Energy Restriction', 'Energy Restriction']


Point-of-care Osteoporosis Diagnostics With Bindex® Pocket Size Instrument and FRAX

Summary: Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture risk. Among 200 million osteoporotic patients (Tarantino, Cannata et al. 2007) most are diagnosed only after several fractures. Furthermore, the progressively aging population will increase the prevalence of osteoporosis. It is estimated that over 75% of osteoporotic patients are not diagnosed and does not receive treatment for their condition.~In this study we aim to investigate the strength of Density Index (DI) for prediction of proximal femur and lumbar spine BMD as well as determining the diagnostic thresholds for DI for osteoporosis diagnostics by using the International Society for Clinical Densitometry guidelines. In addition we aim to investigate how many additional women would be identified for osteoporosis diagnosis/ treatment based on adding FRAX to Bindex versus adding FRAX to DXA.~The investigators will start and organize a multicenter study in 5 osteoporosis clinics in Suomen Terveystalo Healthcare Service Company in Finland. A total of 1100 postmenopausal women (age 50 -79 years) will be measured with both axial DXA and Bindex. In addition, the FRAX questioinnaire will be asked from everybody attending the study.~Clinical hypotheses:~Cortical bone thickness is decreased in osteoporosis.~Patient age, weight and height are related to BMD status and therefore are needed in BMD estimation (Density Index).~Ultrasound is a safe method in osteoporosis screening and diagnostics for osteoporosis.~Fracture risk factors (FRAX) and point-of-care bone density measurement together have significantly higher sensitivity and specificity for osteoporosis/treatment decisions than one method alone.
Inclusion criteria: Osteoporosis suspicion

 inclusion criteria:

 Age: 50 - 59 years (n = 500) and 60-79 years (n = 500).

 Post-menopausal status.

 At least one of the clinical risk factors for fracture:

 Low body mass index (< 19kg/m2)

 Previous fragility fracture

 Parental history of hip fracture

 Glucocorticoid treatment (≥ 5mg prednisolone daily or equivalent for 3 months or more)

 Current smoking

 Alcohol intake 3 or more units daily

 Causes of secondary osteoporosis:

 Untreated hypogonadism

 Inflammatory bowel disease

 Prolonged immobility

 Organ transplantation

 Type 1 and type 2 diabetes

 Thyroid disorders

 Chronic obstructive pulmonary disease

 A Physician has referred the woman to axial DXA investigation.

Exclusion criteria: :

 Treatment: osteoporosis medication.

 Obesity: body mass index BMI > 30kg/m2

 a refusal to participate in the study

 Healthy

 inclusion criteria:

 Age: 50 - 59 years (n = 50) and 60-79 years (n = 50).

 Post-menopausal status.

 No diseases or treatments which may affect to bone health.


Peripheral Perfusion Targeted Fluid Management

Summary: Impaired peripheral perfusion is related to worse outcome in critically ill patients. Although this is known, these parameters have never been used as target for hemodynamic therapy.~We hypothesize that targeting of fluid administration on parameters of peripheral perfusion might prevent excessive fluid administration, leading to less formation of tissue edema, less respiratory dysfunction and shorter duration of mechanical ventilation in critically ill patients.
Inclusion criteria: inclusion criteria:

 All adult patients (>18 years) admitted to the intensive care with 1) hemodynamic instability due to severe sepsis, and 2) a mean arterial pressure < 65 mmHg and 3) an arterial lactate concentration > 3.0 mmol/L will be considered for participation

Exclusion criteria: :

 moribund.

 severe coagulation disorder (contraindication for central venous catheter placement).

 severe peripheral vascular disease (interfering with peripheral perfusion measurement).


Comparison Study in the Treatment of Uterine Fibroids Uterine Fibroid Embolization Using BeadBlock™ Embolic Agent

Summary: A double arm (non-inferiority) 44 patient study to assess the performance of BeadBlock™ in the treatment of uterine fibroids by embolization with respect to clinical & imaging outcome with comparison of primary safety endpoints to Embosphere.
Inclusion criteria: inclusion criteria:

 Patient chooses to participate and has signed informed consent

 Age between 30 and 50 years old

 Symptoms caused by uterine fibroids, such as heavy bleeding (menorrhagia) and/or bulk-related complaints such as urinary frequency, constipation or pelvic pain.

 Patient has fibroids confirmed by MRI

 Patient has normal kidney function.

 Patient is willing and able to undergo follow-up imaging at 3 and 6 months post UFE.

Exclusion criteria: :

 Patients who are pregnant or plan to become pregnant within the study period, or desire future fertility.

 Patients with a history of gynecologic malignancy

 Patients with known endometrial hyperplasia

 Patients with adenomyosis

 Patients with pelvic inflammatory disease

 Patients with Uteri < 250 ml (cm) calculated volume or > 24 weeks

 Patients with pedunculated subserosal fibroids with a narrow attachment (<50% diameter of the fibroid) to the uterus.

 Patients with pelvic pain as dominant syndrome

 Known allergy to contrast media that cannot be adequately pre-medicated.

 Patients not suitable for arterial access.

 Previous uterine artery embolization attempts.

 History of pelvic irradiation.

 Patients on GnRH Therapy within 3-6 months prior to the study enrollment.

['Uterine fibroid embolization BeadBlock™', 'Uterine fibroid embolization Embosphere®']

['Leiomyoma', 'Leiomyomatosis', 'Uterine Neoplasms']

Leiomyoma
Leiomyomatosis
Uterine Neoplasms


Internet-CBT for Insomnia

Summary: This study includes two sub-trials.~In trial 1 patients suffering from insomnia but not meeting the criteria for depression are randomised to either therapist guided Internet-based CBT for insomnia or to a control group with a non-guided, brief self-help program that acts as a placebo control. The primary purpose is to evaluate reduction in Insomnia severity (compared to placebo) after treatment and at follow-ups at 6-month, 1 year and 3 years. Secondary purpose is to evaluate the costeffectiveness of the treatment and to evaluate if the insomnia treatment has a preventive effect on future depressive episodes. Recruitment is done through mass media and includes all regions of Sweden. Initial assessment based on questionnaires and telephone interviews.~Trial 2 includes patients suffering from both Insomnia and depression. Randomization is done between either CBT for insomnia or CBT for depression (both Internet-based) to evaluate each respective treatment's effect on both insomnia and depression. The patients need for further treatment after the initial one will be measured and used as a secondary outcome. Recruitment is done through mass media but only citizens in the Stockholm area are included since the initial assessment are based on both questionnaires and telephone interviews as well as a visit at a psychiatrist located at the Internet psychiatry clinic in Stockholm.~Both trials will include health economic data and analysis. For the longer follow-up periods (1 and 3 years), registers will be used to analyse consumption of sleep medication and antidepressants as well as general health care utilization.
Inclusion criteria: inclusion criteria:

 Clinical level of Insomnia (more than 10 on ISI)

 Meets criteria for Insomnia according to DSM-IV-TR

 Enough language skills

 Only Trial 2: Meets criteria for Major Depressive Disorder according to DSM-IV-TR

Exclusion criteria: :

 Sleep disorders requiring other treatment

 High consumption of alcohol/drugs that affect sleep

 Started to use or changed the dose of antidepressant drug during the last 2 months

 Somatic or psychiatric conditions requiring acute care

 Working night shifts

 Only Trial 1: Meets criteria for Major Depressive Disorder according to DSM-IV-TR

['Therapist guided Internet-CBT for insomnia', 'Brief Internet-CBT for insomnia, without support', 'Therapist Guided Internet-CBT for depression']


Markers of Airway Inflammation in BAL Fluid From Children With Asthma

Summary: The study compares the biochemical markers in bronchoalveolar lavage samples from asthmatic children to those markers found in non-asthmatic children with other respiratory diseases. The investigators hypothesize that certain markers will be associated specifically with asthma.
Inclusion criteria: inclusion criteria:

 18 years of age or younger

 Scheduled for bronchoscopy at National Jewish Health for persistent asthma, persistent, poorly controlled wheezing, chronic cough, GERD, atelectasis, bronchopulmonary dysplasia, infection.

 Consent and assent from parent and patient [if appropriate].

Exclusion criteria: :

 Unwillingness to consent/assent to retrieval of BAL fluid for research analysis.


Once Daily Enoxaparin for Outpatient Treatment of Acute DVT and/or Pulmonary Embolism

Summary: To investigate the efficacy and safety of once daily enoxaparin as a bridge to warfarin for the outpatient treatment of acute deep venous thrombosis or pulmonary embolism.
Inclusion criteria: inclusion criteria:

 Symptomatic acute deep venous thrombosis and/or pulmonary embolism confirmed by venous ultrasound and/or CT scan.

 Pulmonary embolism patients with normal right ventricular size on chest CT scan.

 Age greater than 18 years

 Anticipated discharge within 72 hours of admission

 Written informed consent

Exclusion criteria: :

 Pregnancy or intend to become pregnant

 Patients requiring ongoing hospitalization > 72 hours

 Hypersensitivity to heparin, pork products or enoxaparin

 Creatinine > 2.0 mg/dl

 Recurrent DVT and/or PE with oral anticoagulation

 Surgery or medical procedure planned during the study that may pose a significant bleeding risk

 Prior history of heparin-induced thrombocytopenia

 Inability to participate for follow up appointments and study visits

 Life expectancy < 30 days

 High risk of bleeding:

 Active major bleeding within 30 days by GUSTO criteria

 History of intracranial bleeding

 Major surgery or trauma within 10 days

 Head injury requiring hospitalization within 1 year

 Intracranial tumor

 Neurosurgery or non-cataract ophthalmologic surgery within 1 month

 Thrombocytopenia

['Deep Vein Thrombosis', 'Pulmonary Embolism']


High Frequency Oscillatory Ventilation Combined With Intermittent Sigh Breaths: Effects on Blood Oxygenation and Stability of Oxygenation

Summary: Background:~Ventilator induced lung injury (VILI) remains a problem in neonatology. High frequency oscillatory ventilation (HFOV) provides effective gas exchange with minimal pressure fluctuation around a continuous distending pressure and therefore small tidal volume. Animal studies showed that recruitment and maintenance of functional residual capacity (FRC) during HFOV (open lung concept) could reduce lung injury.~Open lung HFOV is achieved by delivering a moderate high mean airway pressure (MAP) using oxygenation as a guide of lung recruitment. Some neonatologists suggest combining HFOV with recurrent sigh-breaths (HFOV-sigh) delivered as modified conventional ventilator-breaths at a rate of 3/min. The clinical observation is that HFOV-sigh leads to more stable oxygenation, quicker weaning and shorter ventilation. This may be related to improved lung recruitment. This has however to our knowledge not been tested in a clinical trial using modern ventilators.~Purpose, aims:~To compare HFOV-sigh with HFOV-only and determine if there is a difference in oxygenation expressed as a/A-ratio and/or stability of oxygenation expressed as percentage time with oxygen saturation outside the reference range.~To provide information on feasibility and treatment effect of HFOV-sigh to assist planning larger studies. We hypothesize that oxygenation is better during HFOV-sigh.~Methods:~Infants at 24-36 weeks corrected gestational age already on HFOV are eligible. Patients will be randomly assigned to HFOV-sigh (3 breaths/min) followed by HFOV-only or vice versa for 4 alternating 1-hours periods (2-treatment, double crossover design, each patient being its own control). During HFOV-sigh set-pressure will be reduced to keep MAP constant, otherwise HFOV will remain at pretrial settings. Outcome will be calculated from normal clinical parameters including pulx-oximetry and transcutaneous monitoring of oxygen and carbon-dioxide partial pressures.
Inclusion criteria: inclusion criteria:

 Infants at 24-36 weeks corrected gestational age

 Already ventilated with high frequency ventilation

 Requiring FiO2=21%-70% to maintain adequate oxygen saturation.

 Clinical stable

 o i.e. ventilated on current settings for more than just a few hours with stable but not necessarily normalized blood gases or transcutaneous values and oxygen requirement.

 Parent(s) or guardian able and willing to provide informed consent

Exclusion criteria: :

 Major congenital cardiovascular or respiratory abnormalities.

 The attending neonatologist responsible for the baby considers one of the ventilation modes unsuitable for the infant.

 Poor skin integrity precluding use of transcutaneous monitoring.

 Lack of parental signed written informed consent.

 Parents under 18 years of age.

['Respiratory Distress Syndrome, Newborn', 'Bronchopulmonary Dysplasia', 'Ventilator Induced Lung Injury']

Respiratory Distress Syndrome
Newborn
Bronchopulmonary Dysplasia
Ventilator Induced Lung Injury


A Study to Assess the Disturbances in Calcitonin Gene in Patients With Gum Disease and Osteoporosis

Summary: Osteoporosis and Periodontitis are multifactorial diseases which share common risk factors.The aim of the present study is to ellucidate polymorphisms in Calcitonin receptor gene? in patients with Osteoporosis and Periodontitis.
Inclusion criteria: inclusion criteria:

 Male and Female

 Patients aged between 35.00 Year(s) to 60.00 Year(s) diagnosed with Osteoporosis and Chronic Periodontitis who are willing to participate in the study

Exclusion criteria: :

 Patients who are Systemically compromised and under medications such as steroids.

 Patients who smoke.Pregnant and lactating mothers are excluded from the study

['Osteoporosis', 'Generalized Chronic Periodontitis']

Osteoporosis
Generalized Chronic Periodontitis


A Registry Study on Hospitalized Patients With Community-acquired Pneumonia in Real-life of China

Summary: The purpose of this study is to evaluate the disease burden of hospitalized patients with CAP and HCAP in real life of China
Inclusion criteria: inclusion criteria:

 Patients > or = 14 years of age

 Patient meets the criteria of community acquired pneumonia

 Patient meets the criteria of healthcare-associated pneumonia

 Informed consent to participate in the study is provided

Exclusion criteria: :

 Patients participating in a clinical trial or other intervention studies

 Patients <14 years of age

 Patient meets the criteria of hospital acquired pneumonia

 Known active tuberculosis or current treatment for tuberculosis

 Non-infectious pulmonary diseases （e.g. pulmonary embolism, pulmonary edema, pulmonary vasculitis, interstitial pneumonia）

 HIV positive


The Effect of GHRH Therapy on Myocardial Structure and Function in Congestive Heart Failure

Summary: PP1- The purpose of this study is to determine whether giving more of the hormone produced by everyone called growth hormone releasing hormone (GHRH) can improve heart function in individuals with congestive heart failure. You must be 50 years old or older, have a diagnosis of congestive heart failure, and have a high likelihood of having lower than normal growth hormone effect. GHRH is approved by the US FDA for treatment in children with growth hormone deficiency because GHRH stimulates Growth Hormone (GH). Its use for treatment of congestive heart failure in adults is investigational.~Growth hormone releasing hormone is a hormone produced in the brain. We will be using synthetic hormone made in the laboratory. It is identical to the hormone in the brain.~Many older people, due to aging have low levels of growth hormone. The aim of this study is to find out whether restoring growth hormone levels to the levels found in younger individuals and then maintaining those levels for 12 weeks will help strengthen heard muscles in older persons with congestive heart failure.
Inclusion criteria: inclusion criteria:

 subjects will be at least 50 years of age,

 women who are post-menopausal.

 clinical evidence of congestive heart failure, with ongoing management by conventional medical therapy

 a left ventricular ejection fraction below 40% as measured by echocardiogram performed within 6 months of study enrollment.

 Left ventricular end-diastolic dimension greater than 60 mm as measured by an echocardiogram performed within 6 months of study enrollment.

 regular heart rate/pacer

 hemodynamically stable and able to complete symptom-limited bicycle ergometry exercise test;

 and be in New York Heart Association Classification II or III.

Exclusion criteria: :

 Subjects with hematocrit equal to or less than 33%;

 body mass index equal to or greater than 40;

 unstable angina within six months;

 inducible ischemia by exercise stress testing, radionuclide scintigraphy, or dobutamine echocardiography;

 known or suspected myocarditis;

 known or suspected restrictive or infiltrative cardiomyopathy;

 coronary artery stenosis >70% and < 100% by catheterization should such data be available;

 inadequate cardiac echo window;

 primary diastolic dysfunction in heart failure

 inability to perform cycle ergometry;

 critical aortic stenosis;

 severe mitral regurgitation by Doppler echocardiography;

 uncontrolled or poorly controlled hypertension;

 hypertrophic cardiomyopathy;

 renal failure, determined by creatinine > 2.0.

 untreated thyroid disease;

 active alcoholism,

 breast cancer;

 prostate cancer;

 inability to provide informed consent;

 uncontrolled hyperlipidemia; (Triglycerides >1200 and/or LDL > 160)

 patients with known bleeding disorders;

 patients using atropine, artane, scopolamine, and cogentin.

 Subjects who have implanted devices that contain metal and are not adherent to the body will be excluded from the MRI testing in this study. These devices include pacemakers, implanted ICD's, infusion pumps, nerve stimulators, metal debris in the eye, or loose metal, such as shrapnel or a bullet.

 Inability to lie flat on back for an extended period of time. The MRI testing requires this posture.

 History of any noncutaneous malignancy within 5 years of screening.

 STUDY TERMINATION CRITERIA:

 The following clinical events will define drop-points for worsening clinical conditions and will terminate subject involvement in the study:

 Unstable angina

 Acute myocardial infarction (chest pain with EKG changes and increased troponin)

 NYHA Class IV heart failure for greater than one week (a brief episode of NYHA Class IV heart failure may result from medical or dietary indiscretion, adverse effects of non-study medications, poorly controlled hypertension and other potentially reversible mechanisms)

 Documented sustained ventricular tachycardia

 Resuscitated cardiac arrest

 Unexplained syncope

 Diagnosis of sleep apnea that is not medically supervised.

 Symptomatic documented bradycardia

 Diagnosis of a new non-cutaneous malignancy

 Developing

['Growth hormone releasing hormone/ placebo']


Chronic Obstructive Pulmonary Disease (COPD)-Related Outcomes and Costs for Patients on Combination Fluticasone Propionate-Salmeterol Xinafoate 250/50mcg Versus Anticholinergics in a COPD-Comorbid Depression/Anxiety Population

Summary: The objective of this study was to examine COPD-related outcomes for patients with comorbid depression/anxiety who are on combination fluticasone propionate/salmeterol xinafoate compared to those receiving anticholinergics.~The prevalence of comorbid depression/anxiety in patients with chronic obstructive pulmonary disease (COPD) is estimated to be high and range from 10-40%, given that the risk of depression/anxiety symptoms is almost 3 times higher in patients with versus without COPD. Additionally, patients with comorbid COPD and depression/anxiety have higher COPD-related healthcare utilization and costs compared to those without depression/anxiety. Therapy with maintenance medications for COPD has been recommended to prevent future adverse COPD outcomes, but the impact of initiating these interventions has not yet been evaluated in a higher-risk population with comorbid COPD-depression/anxiety. The present study compares the risk of COPD exacerbations and COPD-related costs in patients initiating maintenance medications for treatment of COPD in a comorbid COPD/depression-anxiety population. Maintenance medications include inhaled corticosteroid (ICS), long-acting beta agonist (LABA), combination drug product of ICS+LABA, and anti-cholinergics (AC) including tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively abbreviated as IPR).
Inclusion criteria: inclusion criteria:

 Diagnosis of COPD in any field in the pre-index period and 60 days after the index date

 Diagnosis of depression/anxiety in any field and a medication for treating depression/anxiety in the pre-index period and 60 days after the index date

 Index date occurs during identification period

 Patients must be continuously eligible during 1-year pre and 1-year post-index date and be of at least 40 years of age

Exclusion criteria: :

 comorbid conditions (respiratory cancer, cystic fibrosis, fibrosis due to tuberculosis, and bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary tuberculosis, sarcoidosis) during the 1 year pre or post-index periods

 No other maintenance medications other than the index medication on or 60 days after the index date

['fluticasone propionate/salmeterol xinafoate', 'Anticholinergics']

['Pulmonary Disease, Chronic Obstructive']


Extended-Release Oxybutynin for the Treatment of Neurogenic Detrusor Overactivity

Summary: The purpose of this study is to evaluate the effects and tolerability (how well a participant can stand a particular medicine or treatment) of flexible dose Oxybutynin Extended-Release (OXY-ER, Lyrinel) including safety and quality of life assessment in participants with neurogenic detrusor overactivity (NDO - the nerves mediating the detrusor muscle do not work properly leading to frequent feeling of need to urinate during the day, night, or both).
Inclusion criteria: inclusion criteria:

 Diagnosis of overactive bladder as a result of neurogenic condition, for example following spinal cord injury, multiple sclerosis (slowly worsening disorder of the central nervous system that causes symptoms such as weakness, incoordination, numbness, problems talking and problems seeing), Parkinson's disease (a progressive disorder of the central nervous system, seen usually in older persons, in which there is slow movement [due to muscle weakness], trembling and sweating), or cerebrovascular accidents (CVAs - stroke-sudden loss of blood supply to brain)

 Women must not be pregnant and be of either non-childbearing potential or is using adequate means of birth control

 Overactive bladder symptoms and/or has urge incontinence episodes

 Must have normal results on urine culture tests and on urinalysis

 ECOG (Eastern Cooperative Oncology Group) performance status score of less than or equal to 3

Exclusion criteria: :

 Participants with 1 or more treatable or conditions, other than neurogenic bladder dysfunction, that may cause urinary incontinence or urgency

 Any medical or unstable condition that precludes their participation in the study or may confound the outcome of the study (participants with or at risk for urinary retention, gastric retention or uncontrolled narrow angle; heart failure or kidney failure; diabetes mellitus; abnormal muscle weakness [myasthenia gravis]; paralysis or inactivity in the intestines that prevents material moving through the gut [intestinal atony or paralytic ileus]; severe inflammation of the bowel [ulcerative colitis] sudden expansion of the large intestine seen in advanced ulcerative colitis or Crohn's disease [toxic megacolon]; history of major lower urinary tract surgery [transurethral resection will be excluded])

 Hypersensitivity to the investigational drug or any of its ingredients (eg, lactose)

 Pregnant or breast feeding female

 Significant bacteriuria (presence of bacteria in the urine) or pyuria (presence of white blood cells) in the urine


Vitamin D and Zinc Levels in Patients Undergoing Ergometry Test

Summary: Low vitamin D levels were found to be associated with cardiovascular morbidity and mortality. Low zinc levels are associated with an increased atherosclerotic burden. Therefore we hypothesized that patients with pathological stress test would have low levels of Vitamin D and zinc compared to patients with a normal stress test.
Inclusion criteria: inclusion criteria:

 Over 18 years old

 CCT > 60 ml/min

 No IHD

 No hyper/hypoparathyroidism

 No active malignancy

 Not taking calcium, phosphate

Exclusion criteria: :

 Under 18 years of age

 Not fulfilling inclusion criteria


Effects of L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Hypothyroidism

Summary: Hypothyroidism is a common clinical entity which is often complicated by dyslipidemia. It is also reported increased risk for incidence of atherosclerosis and resulting coronary heart disease(CHD), heart failure(HF) and cardiovascular(CV) death. The effect of L-thyroxine replacement treatment on serum lipid and atherosclerosis is controversial in hypothyroid patients, especially in those with mild or moderate subclinical hypothyroidism. The present study was designed to investigate whether L-thyroxine replacement was effective in improving serum lipid profiles and retarding atherosclerosis progress.~Studies have shown that hypothyroidism increased the risk of COVID-19 composite poor outcomes. This study also aimed to investigate whether L-thyroxine replacement therapy was effective in reducing the incidence and mortality of COVID-19, and in improving the severity of COVID-19 and COVID-19 related complications.
Inclusion criteria: inclusion criteria:

 40

 75 years old

 Diagnosis of overt or subclinical hypothyroidism in two occasions with a minimum interval period of three months

Exclusion criteria: :

 Pregnant or lactating women

 Severe hepatic or renal dysfunction

 Psychiatric disabilities, acute cardiovascular and cerebrovascular diseases, chronic respiratory diseases, familiar hypercholesterolemia, malignancy, cholelithiasis, pancreatitis, bowel diseases and other disorders influencing lipid and bile acid metabolism

 Taking lipid-lowering agents and other drugs influencing thyroid function, lipid and bile acid metabolism

 Obviously poor compliance.

['Hypothyroidism', 'Thyroid Diseases', 'Endocrine System Diseases']

Hypothyroidism
Thyroid Diseases
Endocrine System Diseases


Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac Cream in the Treatment of Acne Vulgaris

Summary: The primary objective of this study is to compare the safety and efficacy of once daily application of IDP-123 Lotion to Tazorac Cream, 0.1%, Vehicle Lotion, and Vehicle Cream in subjects with moderate to severe acne vulgaris.
Inclusion criteria: inclusion criteria:

 Male or female at least 12 years of age and older

 Written and verbal informed consent must be obtained

 Subject must have a score of moderate or severe on the Evaluator's Global Severity assessment

 Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the screening and baseline visits

 Subjects must be willing to comply with study instructions and return to the clinic for required visits

Exclusion criteria: :

 Any dermatological conditions on the face that could interfere with clinical evaluations

 Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive

 Subjects with a facial beard or mustache that could interfere with the study assessments

 Subjects who are unable to communicate or cooperate with the Investigator

 Subjects with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subjects safety while participating in the study

['IDP-123 Lotion', 'Tazorac Cream, 0.1%,', 'Vehicle Cream', 'Vehicle Lotion']

IDP-123 Lotion
Tazorac Cream
0.1%,
Vehicle Cream
Vehicle Lotion


Safe & Easy for Alzheimer's Disease and Related Pathologies

Summary: All over the world the increasing prevalence of chronic disorders and its impact on functional decline is challenging the sustainability of health care systems. Older individuals also frequently experience the reversible frailty syndrome, which overlaps with chronic diseases, increasing incidence of disability.~Building a global system aiming to take in charge all causes leading to loss of autonomy is a rather complicated task involving numerous Information and Communication technologies (ICT) solutions which are not always easy to use in everyday life.~The SafEE (Safe Easy Environment) project aim is to improve the safety, autonomy and quality of life of older people at risk.~The SafEE2 project develop non pharmacological therapeutic through diferent ICT (stimulation aromatherapy automatic fragrance ...) .~The goal of this study is to validate the acceptability, sensitivity and efficacy of the systems.
Inclusion criteria: inclusion criteria:

 Subjects with a diagnosis of Alzheimer's disease according to NINCDS-ADRDA (McKhann, Drachman et al. 1984) or typical or atypical Alzheimer's disease (Dubois B. et al. 2007).

 Score at Mini Mental Test (MMSE) ≥16.

 Subjects residing in nursing homes.

 Subjects beneficiaries of a social security scheme.

 Signature of free and informed consent.

Exclusion criteria: :

 Failure to pass the neuropsychological tests because of a sensory or motor deficit.

 Sensory deficit (olfactory or visual) preventing the patient made perfectly meet the therapeutic solutions.

 Prescription of a new treatment psychotropic (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week before the evaluation;

 Persons deprived of liberty (administrative or judicial).

Patient's answer with non pharmacological therapeutic


Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography

Summary: The purpose of this study is to evaluate and compare overall patient comfort profile between an Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media (LOCM), iopamidol 370 mg I/mL in patients undergoing arteriography of peripheral arteries.
Inclusion criteria: inclusion criteria:

 The subject is over 18 years old.

 Subjects are referred to undergo a peripheral arteriography as part of their routine clinical care.

Exclusion criteria: :

 The subject has known allergies to iodine or any prior history of adverse reaction to iodinated CM.

 The subject received another administration of CM within 24 hours prior to baseline or is scheduled to receive one within the 24 hour follow-up period.

 The subject is pregnant or lactating.

 The subject is taking metformin (e.g., Glucophage®) but is not willing or unable to discontinue at the time of the study procedure.

 The subject manifests thyrotoxicosis or is on dialysis.


Response To Cardiac Resynchronization Therapy In Heart Failure: Role Of Arterial Stiffness

Summary: To determine if arterial stiffness as measured by non-invasive pulse wave velocity can predict the response to resynchronization therapy in heart failure.
Inclusion criteria: inclusion criteria:

 The patients receiving CRT are medically refractory, symptomatic, NYHA class III or IV disease and QRS duration of 130 m sec or greater, and a left ventricular ejection fraction of 30 percent or less.

 All individuals are carefully selected after appropriate clinical evaluation as determined by the treating physicians to exclude possible reversible causes of heart failure.

Exclusion criteria: :

 Patients with permanent atrial fibrillation and non-palpable carotid and/or femoral pulses will be excluded due to technical limitations of the procedure used for the measurement of arterial stiffness.


Transpulmonary Thermodilution and Transesophageal Echocardiography in Early Septic Shock

Summary: The purpose of this study is to assess the concordance of therapeutic changes proposed after an early hemodynamic evaluation (hemodynamic profile) in septic shock patients using jointly the transpulmonary thermodilution technique and transesophageal echocardiography (TEE).
Inclusion criteria: inclusion criteria:

 ventilated patient in sinus rhythm with septic shock requiring a hemodynamic assessment

Exclusion criteria: :

 < 18 yr-old

 pregnancy

 contra-indication for TEE, non sinus rhythm, aplasia, prior participation to the study, hemodynamic assessment using any other technique than those tested in the study.


Add on Study on Δ9-THC Treatment for Posttraumatic Stress Disorders (PTSD)

Summary: Stress Disorder (PTSD) is a chronic and debilitating anxiety disorder which is widespread in every social level and is very prevalent in outpatient and inpatient settings.~A recent open-label study showed that the synthetic cannabinoid receptor agonist Nabilone had beneficial effects abolishing or greatly reducing nightmares that persisted in spite of treatment with conventional PTSD medications. Furthermore, a big number of patients suffering from chronic PTSD report using smoked marijuana because its tranquilizing effect and sleep quality improvement. According to clinical and epidemiological data different derivates from the cannabis plant are illegally and pervasively consumed by PTSD patients in order to reduce distress.~The aim of the proposed study is to broaden the previous observations and to measure the extent to which Δ 9-THC will bring to significant improvement on the full spectrum of PTSD symptoms.
Inclusion criteria: inclusion criteria:

 Outpatients between the 19-60 years of age with a diagnosis of PTSD.

 Women must not be currently pregnant and must use a reliable method of contraception for the duration of the study.

 Subjects must be on stable medication (4 weeks minimum) for their PTSD (symptomatic despite current treatment), must be able to provide written informed consent, must be able adequately understand and comply with the study's instructions and protocol .

Exclusion criteria: :

 Those not meeting the inclusion criteria and those not able to give informed consent.

 Women who are currently pregnant or nursing.

 Those at immediate risk of harming self or others; those who have a clinically significant medical illness or other significant psychiatric illness;

 currently abusing alcohol or drugs;

 currently being treated with an investigational medication or medication that is contraindicated with cannabinoids;

 have a known allergy to cannabis-based products.


Post-Market Clinical Follow-Up Study to Confirm Clinical Performance and Safety of the Codman Enterprise® 2 Vascular Reconstruction Device in the Endovascular Treatment of Intracranial Aneurysms

Summary: The objective of this Post-Market Clinical Follow-up (PMCF) is to confirm the performance and safety of the Codman Enterprise® 2 when used in conjunction with endovascular coil embolization of ruptured or non-ruptured intracranial aneurysms.
Inclusion criteria: inclusion criteria:

 Subject ≥ 18 years old.

 Subjects with non-ruptured or ruptured intracranial aneurysm that is referred for endovascular treatment.

 Parent vessel with a diameter of ≥ 2.0 mm and ≤ 4 mm.

 Subject understands the nature of the procedure and provides voluntary written informed consent in accordance with the requirements of this study protocol.

 Subject is willing to participate in the telephone follow-ups and to return to the investigational site for the post-procedure follow-up evaluations.

Exclusion criteria: :

 Angiogram demonstrating that the aneurysm is not appropriate for endovascular treatment (i.e.: severe intracranial vessel tortuosity, stenosis, intracranial vasospasm not responsive to medical therapy).

 Mycotic or traumatic aneurysm.

 Arteriovenous malformation (AVM) in the territory of the target aneurysm.

 Two or more aneurysms (>2mm) in associated distribution.

 Hunt and Hess Scale (HHS) of IV or V at inclusion for subject with ruptured aneurysms.

 Life expectancy of less than 6 months as determined by the treating physician.

 A planned staged procedure (i.e. a procedure where entire treatment with the devices (e.g. coils/stents) is completed over separate sessions).

 Previous neuro-interventional or neuro-surgical procedure of any kind within 30 days prior to the study procedure.

 Intracranial mass (tumor, abscess, or other infection), or undergoing radiation therapy for carcinoma or sarcoma of the head or neck region.

 Unsuitable for the antithrombotic and/or anticoagulant therapies

 Serum creatinine level > 2.5 mg/dl within 7 days prior to index procedure

 Known hypersensitivity or allergies to cobalt, nitinol metal, nickel, or sensitivity to contrast media,

 Evidence of an acute myocardial infarction (MI) within 30 days prior to the index procedure.

 Uncontrolled atrial fibrillation or known cardiac disorders likely to be associated with cardioembolic symptoms.

 Subject is pregnant

['Enterprise 2 Vascular Reconstruction Device']


The Effect of N-Acetylcystein on Quality of Life and Air Trapping During Rest and After Exercise

Summary: Treatment of COPD patients depends on the stage of the disease. First of all it is strongly recommended quit smoking, then bronchodilators drugs are added. In more advanced stages inhaled corticosteroids and pulmonary rehabilitation are added. In hypoxemic patients a long term supplemental oxygen is advised.~The addition of sputum modifiers drugs is equivocal, since no objective improvement was documented.~N-Acetylcystein (NAC) is a drug known for its anti-oxidant and mucolytic activity. In animal models of disease it showed its beneficial activity , whereas in human such changes weren't demonstrated. In all the studies FEV1 was used to demonstrate the beneficial effect of the drug, although the disease changes are at the level of small airways which is almost not expressed by the measurement FEV1.~Purpose of the study~To estimate the damage severity at the small airways.~To estimate the change in quality of life.~To assess the pulmonary function changes at rest and following exercise, including parameters of air trapping (hyperinflation)~Methods & Materials Patients - Inclusion - 30 Moderate COPD (GOLD classification) , AGE 45-70, both sexes. Treated with inhaled steroids and long acting beta agonists.~Exclusion - Active ischemic heart disease, heart failure, orthopedic problems that preclude ergometric bicycle activity.~Questionnaire - The St. George questionnaire for quality of life will be used . Pulmonary function testing- Lung volumes and spirometry un including inspiratory capacity will be measured before and after exercise.~Study protocol - 2 weeks run in, for observation disease stability and drug adherence.~Patient will randomly separated in 2 groups . Group A - will receive 600-1200 mg N-acetyl cystein twice daily. Group B - will receive as control placebo . Following 4 weeks of treatment patient will clinically re-examined and PFT's performed as described. After 2 weeks of washout group A. will serve as control and group B. will be treated with NAC as described.
Inclusion criteria: inclusion criteria:

 30 Moderate COPD (GOLD classification) , AGE 45-70, both sexes.

 Treated with inhaled steroids and long acting beta agonists.

Exclusion criteria: :

 Active ischemic heart disease, heart failure, orthopedic problems that preclude ergometric bicycle activity.

['Effect on small airways (N-Acetylcystein)']


Anticoagulation Length in Cancer Associated Thrombosis

Summary: This is a two year, multicentre, mixed methods feasibility study including a randomised controlled two-arm interventional trial, a nested qualitative study, focus groups and a United Kingdom (UK) wide survey exercise.
Inclusion criteria: inclusion criteria:

 Receiving LMWH for treatment of CAT for five months

 Locally advanced or metastatic cancer

 Able to self-administer LMWH, or have LMWH administered by a carer

 Able to give informed consent

 Age ≥16 years

Exclusion criteria: :

 Receiving drug other than LMWH for CAT

 Contraindication to anticoagulation

 Fitted with a prosthetic heart valve

 Pregnant and/or lactating females

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

Cancer
Thrombosis
Venous Thromboembolism
Deep Vein Thrombosis
Pulmonary Embolus


Summary: Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR
Inclusion criteria: inclusion criteria:

 male or female subjects ≥ 12 years

 2 year history of seasonal allergic rhinitis

 documented hypersensitivity to local seasonal allergens (grass pollen)

 documented pollen-induced asthma

 without acute ongoing exacerbation of asthma or allergic rhinitis

 no continuous ongoing treatment for rhinitis or asthma

Exclusion criteria: :

 non-allergic rhinitis and anatomic abnormalities disturbing the analysis of nasal capacity

 symptomatic rhinitis or asthma due to tree pollens

 currently treated by specific grass pollen immunotherapy

 suffering from non-allergic asthma

 chronic use of inhaled steroids and/or long acting β2 agonists; and/or corticosteroid dependent asthma

 atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids

 contraindication for salbutamol use


Anatomical, Radiological and Biomechanical Examination of Athletic Groin Pain Patients and Physical Therapy Intervention

Summary: Athletic groin pain (AGP) is a chronic condition common in multi-directional sports (Walden et al. 2007, Robinson et al. 2004, Murphy et al. 2012). It is a complex injury with a challenging diagnosis. Dramatic differences in the anatomical diagnoses of AGP cohorts exist in the literature (Renstrom et al. 1980, Lovell et al. 1995, Holmich et al. 2007, Bradshaw et al. 2008). This may be due to the complexity of the anatomy in the region and the absence of magnetic resonance imaging (MAGNETIC RESONANCE IMAGE) to confirm clinical examination.~Dynamic actions undertaken in field sports (including change of direction cutting) are particularly associated with the development of athletic groin pain (Holmich et al. 2014). Dynamic multi-plane, multi-joint actions can overload musculoskeletal and fascial structures in the hip and groin. Despite this, traditional groin pain assessments do not involve an examination of sport specific actions. An examination of jumping, hopping and cutting mechanics, which is possible with the use of three dimensional motion capture techniques, will provide additional information with which to diagnosis and rehabilitate athletes.~While the majority of published studies on AGP have focused on surgical management (Serner et al. 2015), exercise therapy has been found to be an effective treatment (Holmich et al. 1995). In exercise therapy studies the best results were shown by Holmich et al (1995) where subjects suffered for an average of 9.9 months with symptoms and a strength and stability program focused on adductor strength returned them to sport in 18.5 weeks. The latest paper on rehabilitation by Jardi et al. demonstrates little improvement with a mean time to return to training of 86 days +/-15. The focus remains on improving strength of isolated muscle groups and not attempting to address underlying biomechanical abnormalities that may be leading to overload. Accurate biomechanical assessment and individualized rehabilitation based on the high speed multiplanar movements that drive the athlete's symptoms may enhance the efficiency of rehabilitation. Moreover post-rehabilitation changes in biomechanical factors may provide a further insight into the biomechanical factors associated with AGP.~The purpose of this study was to:~Describe clinical presentation (physical examination and magnetic resonance imaging findings) for a group of athletes presenting with AGP~To describe the different biomechanical diagnoses that exist in AGP patients~To examine the effects of a biomechanics led exercise intervention to rehabilitate chronic groin pain~It is hypothesised that standardised magnetic resonance imaging will aid in the anatomical diagnosis of athletic groin pain patients. From a biomechanics perspective, distinct subgroups/clusters will exist that differ from each other in how they undertake dynamic sport specific actions. These distinct clusters will describe potential biomechanical diagnoses that exist in groin pain patients. A biomechanics led rehabilitation program will return groin pain patients back to sport more quickly than previous rehabilitation programs without biomechanical diagnostic information.~Brief protocol Participants will be recruited from patients with chronic athletic groin pain who present for investigation and rehabilitation at Sports Surgery Clinic, Ireland. A standardised clinical examination will be undertaken including range of motion assessment, pain provocation and load tolerance tests, and palpation.~A Magnetic Resonance Image of the hip and groin region will then be undertaken and read by a consultant sports physician.~Biomechanical assessment will include capturing of jumping, hopping and cutting mechanics through the use of three dimensional motion capture technology and force plates. Here reflective markers are placed on the skin at anatomical landmarks. These markers are picked up by the cameras and tracked at 200 frames per second. Participants will contact the force plate with their foot on undertaking the movements. Force and marker data will be combined to calculate joint angles and moments.~Physical therapy assessment will include an assessment of functional movement, range of motion testing, adductor squeeze tests, strength assessment of hip and trunk. Physiotherapists will utilise three dimensional biomechanical data during cutting and landing to inform individualised rehabilitation. Rehabilitation will consist of movement control, whole body strength and power, linear running mechanics, multi-directional mechanics and conditioning sessions. Participants will have follow up physical therapy appointments approximately every two weeks. A hip and groin outcome score (HAGOS) will be used to monitor the morbidity and severity of the injury throughout the rehabilitation process.~Once the physiotherapist determines that the patient is ready to return to play a biomechanical re-test will be undertaken.
Inclusion criteria: inclusion criteria:

 Diagnosis of athletic groin pain

 Professional athlete in full time training with groin pain diagnosis

Exclusion criteria: :

 Post infective osteitis

 Bone tumour

 Acute injury

['Biomechanics led physical therapy rehabilitation']


Genomic Response Analysis of Heart Failure Therapy in African Americans

Summary: The response to therapy with a fixed dose combination of isosorbide dinitrate and hydralazine (FDC I/H) is enhanced in African Americans with heart failure and reduced ejection fraction (HFrEF) when compared to similar white cohorts. This study will seek to confirm the previous genetic sub-study from AHeFT which suggested a functional polymorphism of guanine nucleotide binding protein beta polypeptide 3 subunit (GNB3), C825T in exon 10, influences the therapeutic efficacy of FDC I/H. This study will initiate treatment with FDC I/H in 500 self designated African American subjects with systolic heart failure. They will be followed for up to two years on therapy. Clinical outcomes (survival, heart failure hospitalizations, and change in quality of life) on FDC I/H will be compared by GNB3 genotype subset. The hypothesis to be confirmed is that subjects homozygous for the T allele (those with the GNB3 TT genotype which is present in approximately 50% of black subjects) demonstrate enhanced therapeutic benefit from FDC I/H.
Inclusion criteria: inclusion criteria:

 18 years and older

 History of heart failure with an LVEF (less than OR equal to) < 0.35 for at least 6 months OR an LVEF < 0.45 with left ventricular internal end diastole (defined by a diameter of more than 2.9 cm per square meter of body surface area OR more than 6.5 cm on the basis of echocardiography). ** Echo must be done within 6 months of enrollment**

 New York Heart Association (NYHA) Class II-IV

 Background heart failure therapy that includes angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBs), and beta blockers (BBs) for at least 3 months (or documentation of intolerance to ACEi/ARBs and BBs)

 Self-designated race as African American or black (would include subjects whose country of origin was outside the USA such as Africa, the Caribbean, or Central America).

Exclusion criteria: :

 History of intolerance to either nitrates or hydralazine

 Treatment with the combination of hydralazine and nitrates for the previous 3 months

 Revascularization or myocardial infarction within last 90 days

 Received cardiac resynchronization therapy (CRT) AND did not have an assessment of cardiac function documenting an LVEF < 35% (less than OR equal to 35%) at least 90 days post CRT

 Presence of clinically significant valvular heart disease, hypertrophic or restrictive cardiomyopathy, active myocarditis, or uncontrolled hypertension. (Note that uncontrolled hypertension is defined as blood pressure consistently greater than 160 mmHg systolic and 95 mmHg diastolic)

 Women who are currently pregnant, planning on becoming pregnant in the next two years, or those who do not agree to prevent pregnancy.

 Subjects who are on continuous home inotropes, a left ventricular assist device, or who are post cardiac transplant.


Cerebral Blood Flow Changes in People With Obesity After Glucose Consumption

Summary: This study evaluates the hypothesis that a meal constituted of only glucose produces differences in the brain blood flow in people with obesity that are not observed in people without obesity. These changes, at least in part, could explain the mechanisms involved in maintenance or development of obesity.
Inclusion criteria: inclusion criteria:

 Live in Ribeirão Preto, São Paulo - Brazil.

 Age between 18 and 40 years old.

 Female gender.

 Regular menses.

 Weight inferior than 120 Kg and body mass index (BMI) between 30 and 40 kg/m2, for the group with obesity.

 BMI between 18,5 and 24,9 kg/m2, for the group without obesity.

Exclusion criteria: :

 High blood pressure, diabetes, glucose intolerance or impaired fasting glycemia, metabolic syndrome, hypothyroidism and any kidney, liver, heart or neurologic disease.

 Psychiatric disorders, alcoholism, smoking or illicit drug abuse.

 Pregnancy or desire to be pregnant

 Use of medications, excluding contraceptives.

 Contraindication for magnetic resonance imaging.

 Be in treatment for obesity.

['75 grams of glucose plus water solution', 'Pure water']

75 grams of glucose plus water solution
Pure water


To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)

Summary: The objective of the study is to compare the oral contraceptive (OC) SH T00658ID over Ortho Tri-Cyclen Lo administered for 13 cycles to healthy female volunteers between 18 and 50 years of age who request oral contraceptive protection. Subjects on a levonorgestrel (LNG), norgestimate (NGM), norethindrone or norethindrone acetate containing oral contraceptive in a 21-day regimen suffering from hormone withdrawal-associated symptoms such as pelvic pain or headache or both, and willing to continue OC use but to switch to SH T00658ID or Ortho Tri-Cyclen Lo.
Inclusion criteria: inclusion criteria:

 Signed and dated informed consent

 Age between 18 and 50 years (inclusive), smokers maximum age of 35 years (inclusive) at Visit 1

 Otherwise healthy female subjects requesting contraception and currently using a LNG, NGM, or norethindrone/norethindrone acetate containing OC in a 21-day regimen and suffering from at least moderate pelvic pain, headache or both defined by an average of the highest 3 values of >/=35 mm on a VAS during cycle days 22-28 (35 mm VAS is the expected standard deviation of the population VAS reduction)

 Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the last 6 months before screening) Women with atypical squamous cell of undetermined significance (ASCUS) can be included if they have a negative human papilloma virus (HPV) test result. The laboratory will perform an HPV test if the Pap smear result is ASCUS.

 Able to tolerate ibuprofen and willing to use only ibuprofen supplied by the investigator

Exclusion criteria: :

 Pregnancy or lactation (less than three cycles since delivery, abortion, or lactation before start of treatment)

 Body mass index (BMI) >32 kg/m2

 Hypersensitivity to any of the study drug ingredients

 Individuals not willing to consume pork and beef products. Women may be included if they are willing to take the capsules

 Safety relevant laboratory values, provided by the central laboratory, outside inclusion range before start of treatment

 Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication (such as but not limited to duodenal ulcers, gastritis, gastrectomy or gastric resection surgery, or renal compromise)

 Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results

 Any disease or condition that may worsen under hormonal treatment

 Undiagnosed abnormal genital bleeding

 Abuse of alcohol, drugs, or medicines (eg, laxatives)

 Other contraceptive methods

 Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results

 Simultaneous participation in another clinical trial prior to study entry that might have an impact on the study objectives at the discretion of the investigator

 Major surgery scheduled for the study period

 Subject is a dependent person, eg: a family member or member of the Investigator's staff

 Inability to cooperate with the study procedures for any reason, including language comprehension, psychiatric illness, inability to get to the study site

['Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'Ortho Tri Cyclen Lo']

Estradiol valerate
Dienogest (Natazia
Qlaira
BAY86-5027)
Ortho Tri Cyclen Lo


Immediate Mobilization After Cardiac Catheterisation

Summary: The purpose of this study is to investigate the frequency of bleeding and haematomas in patients undergoing coronary angiography or percutaneous coronary intervention via femoral artery and mobilized immediately after the procedure, compared to those mobilized after two hours (following the standard regimen). At the same time the investigators will investigate whether it reduces the discomfort being mobilized immediately after the procedure.
Inclusion criteria: inclusion criteria:

 CAG or PCI performed via the femoral artery

 No hematoma in the groin (> 5 cm in diameter)

 Heparin reversed with protamine after PCI

Exclusion criteria: :

 Oozing, bleeding or hematoma

 Treatment with Integrilin, ReoPro, or Marevan

 Heparin can not be reversed

 The patient does not want to participate

 Systolic blood pressure > 180 mm Hg after the procedure

 BMI> 35 (can be modified if the groin can be assessed in an upright position)

 Demented, unconscious patients who do not understand the information for participants.

['Immediate mobilization', 'Two hours bedrest']

Immediate mobilization
Two hours bedrest

['Vascular Access Complication', 'Comfort']


Diaphragm Activity During Incentive Spirometry and Diaphragmatic Breathing

Summary: The objective of the present study is to evaluate diaphragm activity during three breathing exercises: diaphragmatic breathing (DB), flow-oriented (Triflo II)incentive spirometry and volume-oriented (Voldyne) incentive spirometry.~Seventeen healthy subjects will be studied (8 man and 9 woman).
Inclusion criteria: inclusion criteria:

 Being 18 to 40 years old

 Having a normal body mass index

 Being a non-smoker

 Not knowing the DB and the IS techniques

 Reporting the absence of respiratory diseases.

Exclusion criteria: :

 Presenting alteration in respiratory function detected by functional analysis of lung volume and capacity

 Inability to understand or perform the procedure.

['Diaphragm Mobility', 'Breathing Exercises', 'Incentive Spirometry', 'Diaphragmatic Breathing']

Diaphragm Mobility
Breathing Exercises
Incentive Spirometry
Diaphragmatic Breathing


DEC033 Study Product for Mild to Moderate Eczema An Open-label, Adaptive-design Pilot Study

Summary: This open-label, adaptive design study was designed to determine the efficacy of the study product in the treatment of eczema which would be assessed by the reduction of the appearance of skin lesions and symptoms associated such as itching, scaling and redness.
Inclusion criteria: inclusion criteria:

 Healthy male or female ≥ 18 and ≤ 70 years of age.

 Body mass index (BMI) ≥ 20 and ≤ 35 kg/m2.

 Subjects with mild to moderate eczema; determined at screening visit.

 Judged by the Investigator to be in general good health on the basis of medical history.

 Agree to use the Study-supplied cleanser and moisturizer as the only body cosmetic applied to irritated skin.

 Agree to stop all medications and supplements during the entire length of the study

 Females of child bearing potential must agree to use appropriate birth control methods during the entire study period.

 Agree not to initiate any new exercise or diet programs during the entire study period.

 Agree not to change their current diet or exercise program during the entire study period.

 Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.

Exclusion criteria: :

 Clinically significant renal, hepatic, endocrine (including diabetes mellitus), cardiac, pulmonary, pancreatic, neurologic, hematologic, or biliary disorder.

 Known allergy or sensitivity to Herbal products.

 History or presence of cancer in the prior two years, including any skin cancer or suspicious lesions.

 Recent history of alcoholism (within 12 months) or strong potential for alcohol or substance abuse.

 Participation in a clinical study with exposure to any non-registered drug product within 30 days prior.

 Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk. Including subjects who are Bed or wheelchair-bound.

 Pregnant, lactating, or unwilling to use adequate contraception during the duration of the study.

 Smoking - must be nonsmoker for at least 12 weeks prior to screening.


Rabies Immunization Concomitant With JEV in Children

Summary: Background. The World Health Organization recommends pre-exposure vaccination (PreP) to protect children living in canine rabies endemic countries. Including PreP in national childhood immunization programs (EPI) is a viable option.~Methods. In an open-label phase II clinical trial, 200 healthy toddlers were randomized to receive Purified Chick Embryo Cell Vaccine (PCECV) in a 3-dose Full-IM (1mL), Half-IM (0.5mL), 3-ID (0.1mL), or a 2-dose 2-ID (0.1mL) regimen, all in combination with two doses of Japanese Encephalitis (JEV), or JEV alone. One booster dose of PCECV (IM or ID) and JEV, or JEV alone was administered concomitantly one year after primary vaccination. Safety was evaluated after each injection. Blood was drawn on days 0 and 49, one year later prior to booster and on days 7 and 28 post-booster, and at two and three years post primary vaccination. All sera were analyzed for rabies and JE virus neutralizing antibodies (RVNA, JEVNA).
Inclusion criteria: inclusion criteria:

 Male and female 12-18 months old toddlers will be included in the study if they;

 are in good health at time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator;

 are available for all the visits scheduled in the study;

 have been granted a written informed consent signed by their parents

Exclusion criteria: :

 a history of rabies immunization;

 a history of Japanese encephalitis immunization or disease;

 a significant acute or chronic infectious disease at the time of enrollment;

 fever > 38.0 degree C (axillary) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment;

 being under treatment with parenteral, oral and/or inhaled corticosteroids, immunosuppressive drugs or other specific anti-inflammatory drugs or having taken chloroquine during the two months period before enrollment;

 administration of any vaccine within the past 14 days before enrollment;

 known immunodeficiency or an autoimmune disease;

 known hypersensitivity to neomycin, tetracycline, amphotericin-B;

 planned surgery during the study period;

 being enrolled in any other investigational trial contemporaneously;

 the family plans to leave the area of the study site before the end of study period;

 history of febrile convulsions;

 history of wheezing


Erythropoietin in Radiocontrast Induced Nephropathy (ERIN) Trial

Summary: Full Title: A Randomized Controlled Trial of Procrit for the Prevention of Acute Renal Failure in Patients Receiving Intravenous Contrast~Primary Objective: To evaluate the efficacy of a one-time dose of intravenous erythropoietin administration in the prevention or attenuation of contrast-induced acute renal failure.~Secondary Objectives: To evaluate serum and urinary markers of renal injury, including KIM-1, BMP-7, and TGF-b, along with other biomarkers, in subjects receiving intravenous contrast and correlate their expression with clinical outcomes~Study Design: Prospective, multi-centered, randomized, double blind, placebo controlled trial of a one-time dose of EPO. Subjects will be followed for seven days or until hospital discharge, whichever is longer. Total estimated study duration 3 years.
Inclusion criteria: inclusion criteria:

 Subjects age 18 and over and of either gender.

 Scheduled to receive CT scan with intravenous contrast dye.

 Non diabetics or subjects with type 1 or 2 diabetes mellitus

 Written informed consent.

 Subjects who are on diuretics and non-steroidal inflammatory agents will not be excluded.

 Subjects who have received n-acetylcysteine or sodium bicarbonate pre CT scan will not be excluded

Exclusion criteria: :

 Pregnant or lactating women.

 End-stage renal disease (on hemodialysis or peritoneal dialysis)

 A known history of acute renal failure

 Subjects receiving glucophage/metformin or glucovance

 Subjects who cannot give written informed consent.

 Subjects receiving peritoneal dialysis or hemodialysis.

 Subjects enrolled in another investigational drug study ≤ 30 days of enrollment into the present study.

 Subjects with a known hypersensitivity or anaphylaxis to contrast dye or iodine.

 Subjects with known hypersensitivity or anaphylaxis to erythropoietin, mammalian-cell derived products, or human albumin.

 Age < 18 years

 Use of any erythropoietin replacement or transfusion within the prior 3 days

 Baseline Hemoglobin > 12.0 g/dL

 Uncontrolled hypertension, systolic BP > 180 mmHg or diastolic BP > 110 mmHg in any recording in the past 24 hours.

 Evidence of hemodynamic instability

 Subject unable to follow protocol due to mental incompetence or other reason

 Inaccessibility of medical record

 Subjects with a history of MI, CVA, active angina or unstable angina within the past three months

 Subjects with a history of current malignancy, where current malignancy is defined as subjects undergoing treatment with chemotherapy or radiation therapy, subjects with known metastatic disease, and those with terminal malignant disease.

 Subject with any known history of seizure disorders


Observation Study an Immunogenicity Modified TRC-ID Regimen With CPRV With or Without Rabies Immunoglobulin in Children

Summary: To determine Immunogenicity and Safety Study of Modified TRC-ID Regimen with A New Chromatographically Purified Vero Cell Rabies Vaccine (SPEEDA®) as post exposure rabies intradermal regimen with or without Rabies Immunoglobulin in Children
Inclusion criteria: inclusion criteria:

 they are 1-15 years healthy children

 give signed informed consent from their parents

 willing to participate in this study and be able to receive the vaccination and collect blood sample as the study plan.

Exclusion criteria: :

 they have prior history of rabies vaccination or any equine/human serum administration such as snake antivenom and tetanus antiserum or vaccine allergy

 Persons who have immunosuppressive conditions such as known HIV infection, transplantation, chronic renal failure, receiving of steroid or immunosuppressive drugs

 person received anti-malarial drugs within the previous two months or any blood products within previous three months were excluded

 Urine pregnancy test must be done in all female adolescents to exclude the pregnancy in first visit


Comparison of Calcium Channel Blockers and Beta Blockers on Tourniquet-induced Hypertension During Intravenous Regional Anesthesia

Summary: The investigators aimed to investigate the efficacy of calcium channel blockers and beta blockers for controlling tourniquet induced blood pressure increase in patients undergoing carpal tunnel operations with IVRA. For this purpose files of patients undergoing operation under IVRA were retrospectively examined in terms of demographical and hemodynamic variables.
Inclusion criteria: inclusion criteria:

 Patients operated due to carpal tunnel syndrome under intravenous regional anesthesia betweem January 2009 and January 2010.

Exclusion criteria: :

 The patients that the files could not be reached

['Calcium channel blocker and beta blocker']


Continuous Positive Airway Pressure (CPAP) After Adenotonsillectomy in Children

Summary: Obstructive sleep-disordered breathing (SDB) affects 2-3% of children and may lead to problems with nighttime sleep and daytime behavior, learning, sleepiness, and mood. Adenotonsillectomy (AT) is the second most common surgical procedure in children. It is now performed more often for suspected SDB than for any other indication. However, recent studies indicate that many if not most children still have SDB after AT, and many still have learning or behavioral problems associated with SDB. The goals of this study are: (1) to assess the extent that behavior, cognition, and sleepiness in children can improve with Continuous positive airway pressure (CPAP) treatment after AT, and (2) to identify which patients stand to gain most from post-operative assessment and treatment.
Inclusion criteria: inclusion criteria:

 Children ages 5-12 years old,

 Scheduled for an adenotonsillectomy for treatment of sleep apnea,

 Child must provide assent, and

 Parent or legal guardian must be able to speak and read English, and agree to the study.

Exclusion criteria: :

 No siblings of children already enrolled in the study,

 Children who expect to have another surgery (in addition to AT) during the period of participation in this study,

 Neurological, psychiatric, or medical conditions, or social factors that may affect test results, prevent children from returning for required study visits, or interfere with the study treatment, or

 Certain medications that affect sleepiness or alertness, for example:

 Stimulants (such as Ritalin, Adderall, or Concerta),

 Sleep aides (such as Melatonin, Ambien, or Ativan), or

 Sedating medicines (such as Benadryl, Klonopin, Xanax, or Valerian).

['Sleep Apnea, Obstructive', 'Sleep Apnea Syndromes', 'Child Behavior Disorders', 'Attention Deficit Disorder With Hyperactivity', 'Disorders of Excessive Somnolence']


Comparison of a Tissue Perfusion Guided Hemodynamic Protocol With a Standard Hemodynamic Protocol in Septic Shock Patients

Summary: The Surviving Sepsis Campaign (SSC) published 2008 revised guidelines to improve survival of septic shock patients. For hemodynamic stabilization the SSC recommends distinct treatment goals. The study hypothesis is that a tissue perfusion guided protocol could reduce the duration on vasopressor treatment compared to a conventional protocol.
Inclusion criteria: inclusion criteria:

 2 or more SIRS criteria according to ACCP/SCCM definition

 Documented infection or strong suspicion of infection with adequate antibiotic treatment

 Shock according to ACCP/SCCM definition with the necessity of vasopressor treatment

Exclusion criteria:

 Patients admitted with central nervous diseases

 ST elevation myocardial infarction

 Pulmonary embolism

 Out of hospital cardiac arrest patients

 Patients with therapy limitations

 Known pregnancy

 Inclusion in other interventional trials

['Tissue perfusion guided protocol', 'Usual Care']

Tissue perfusion guided protocol
Usual Care