Electrothermal Arthroscopic Capsulorrhaphy (ETAC) and Open Inferior Capsular Shift in Patients With Shoulder Instability

Summary: This trial will compare the effectiveness of electrothermal arthroscopic capsulorrhaphy (ETAC) to the current reference standard procedure, open inferior capsular shift (ICS), for the treatment of shoulder instability caused by ligamentous capsular redundancy. Multi-directional instability (MDI) and multi-directional laxity with anteroinferior instability (MDL-AII) are the two types of shoulder instabilities included in this trial.~Hypothesis: There is no difference in disease-specific quality of life between patients undergoing an ETAC versus an open ICS for the treatment of shoulder instability caused by capsular ligamentous redundancy.
Inclusion criteria: inclusion criteria:

 Ages 14 years or greater

 Diagnosis of MDI or MDL-AII. Diagnosis will require two or more of the following:

 Symptomatic translation (pain or discomfort) in one or more directions: anterior, inferior and/or posterior;

 Ability to elicit unwanted glenohumeral translations that reliably produce symptoms with one of the following tests: the anterior and posterior apprehension tests, the anterior and posterior load and shift tests, the fulcrum test, the relocation test, the Fukuda test, and/or the push-pull or stress test with the patient supine;

 Presence of a positive sulcus sign of 1 centimetre or greater gap that reproduces the patient's clinical symptoms of instability and should be both palpable and visible;

 Symptoms of instability: subluxation or dislocation.

 Written informed consent

 Failed at least 6 months of non-operative treatment

 Confirmed capsular-ligamentous redundancy as determined by diagnostic arthroscopy examination.

Exclusion criteria: :

 Neurologic disorder (ie: axillary nerve injury; syringomyelia)

 Cases involving third party compensation

 Patients with primary posterior instability

 A bony abnormality (Hill Sachs/bony Bankart) on standard series of x-rays consisting of a minimum of an anteroposterior view, lateral in the scapular plane and an axillary view

 Presence of a Bankart lesion on arthroscopic exam of the joint

 Presence of an unstable biceps anchor (ie: superior labral anterior and posterior [SLAP] lesion) on arthroscopic exam of the joint

 Presence of a full-thickness rotator cuff tear.

['Electrothermal arthroscopic capsulorrhaphy (ETAC)', 'Open inferior capsular shift (ICS)']


HEAVy HAT-HEAlthy Volunteers Heart to Arm Time. Haemorrhage Simulation Protocol in Healthy Volunteers

Summary: In prehospital settings, hypovolemic shock diagnosis is based on Advanced Trauma Life Support (ATLS) shock classification. The most often used clinical signs are heart rate (HR), arterial blood pressure (BP), respiratory rate, neurologic status, diuresis, skin colour and temperature. However, some of these signs, such as hypotension and tachycardia, lack specificity and sensitivity and do not occur early enough. Even with an early preload reduction, blood pressure can remain constant due to compensatory mechanisms, such as vasoconstriction and positive chronotropism. Tachycardia occurs earlier, but has poor specificity and sensitivity. A retrospective analysis of 25,287 trauma patients showed that among 489 patients presenting with systolic BP < 90 mmHg, only 65% had tachycardia (HR > 90 bpm), while 39% of patients with systolic BP > 120 mmHg were tachycardic, probably resulting from other stimuli influencing heart rate, such as pain, fear, circulating hormones and endogenous enkephalins. Therefore, it could be very useful to have an index that identifies initial volume variation, when physiological regulatory mechanisms are still effectively maintaining normal BP.~Pulse transit time (PTT) is the sum of pre-ejection period (PEP; the time interval between the onset of ventricular depolarization and ventricular ejection) and vascular transit time (VTT; the time it takes for the pulse wave to travel from the aortic valve to peripheral arteries). PEP and VTT variations depend on preload variation, and PTT increases with PEP, showing a linear correlation (R2 = 0.96). Chan et al. subjected 11 healthy volunteers to the head-up tilt test, and demonstrated that PEP increased and VTT decreased for increasing tilt angles from 0° to 80°, corresponding to light-moderate bleeding. They also observed early sympathetic activation, expressed by decreases of both RR interval (RR) and VTT, dampening the PTT increase, since PTT is influenced by both continuous PEP increase and progressive VTT decrease occurring during hypovolaemia.~Here the investigators describe a new index, called indexed Heart to Arm Time (iHAT). iHAT is the mPTT/RR ratio, where mPTT is a modified PTT, measured from the onset of ventricular depolarization (the 'R' wave of the ECG trace) to the systolic peak of the photoplethysmographic pulse oxymetry (PPG) waveform. mPTT is indexed to RR interval on ECG to counteract sympathetic activation that would dampen PEP increase and enhance VTT reduction, by means of positive inotropism and peripheral vasoconstriction, respectively. iHAT therefore increases during haemorrhage because of preload reduction and the consequent PEP increase and RR interval decrease. iHAT is expressed as the time percentage of the interbeat interval (RR) it takes to the PPG waveform to travel to peripheral arteries. In this study iHAT has been calculated as the average of beat-to-beat mPTT/RR ratios over 30 heart beats (corresponding to at least 2 breathing cycles) in order to minimize the effect of spontaneous breathing on preload, and thus on PEP and PTT.~In the present study, the investigators aimed to evaluate iHAT in a simulating model of hypovolaemia by using a Lower Body Negative Pressure (LBNP) chamber. LBNP chamber simulates haemorrhage by applying negative pressure to the lower limbs, thus giving an accurate model of hypovolemia. The LBNP chamber has been used for many years for research purposes, and in 2001 Convertino suggested it is a useful device to test severe haemorrhage-related hemodynamic responses. In fact, the induced volemic sequestration is an efficient technique to study physiological behaviours in humans.~The primary endpoint was to evaluate the use of the iHAT as a predictor of hypovolaemia. The secondary endpoint was to compare the specificity and sensitivity of the iHAT index compared to commonly used indexes (BP, HR). Furthermore, the investigators aimed to assess feasibility of Transthoracic echocardiography (TTE) evaluation of Cardiac Output (CO) in a haemorrhagic model and to evaluate CO changes with respect to measured hemodynamic variables.~TTE evaluation of CO is non invasive and comparable to thermodilution, and of possible use in an emergency setting.
Inclusion criteria: inclusion criteria:

 30 healthy volunteers with no assumption of coffee or any other substance with possible action on the autonomic nervous system.

Exclusion criteria: :

 age < 18 yrs,

 pregnancy,

 assumption of any drugs and existence of any disease,

 intake of any drug/substance with action on the autonomic nervous system during the previous 24 hours.

['LBNP Lower Bodi Negative Pressure Chamber']


BEL114333, a Continuation Study of BEL113750 in Subjects With Systemic Lupus Erythematosus (SLE) in Northeast Asia, and in Japan Subjects Completing the Open-label Extension of HGS1006-C1115

Summary: This study provides subjects who complete the BEL113750 study and subjects who complete the open-label extension of HGS1006-C1115 (referred to as C1115) Study in Japan the option of continuing treatment with belimumab (10 mg/kg intravenously every 4 weeks) for those randomized to belimumab, or the option to begin treatment with belimumab for those randomized to placebo, as an add-on to their standard of care SLE therapy.
Inclusion criteria: inclusion criteria:

 Have completed the BEL113750 Protocol in Northeast Asia through Week 48 OR have completed the open-label extension of C1115 in Japan.

 Be able to receive the first dose of belimumab for BEL114333 four weeks (minimum of 2 weeks, maximum of 8 weeks) after the last dose in BEL113750 OR be able to receive the first dose of IV belimumab 1 week (plus a 1 week visit window) after the last dose of open-label SC belimumab in C1115..

Exclusion criteria: :

 Have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or experienced an adverse event (AE) in the Phase 3 study that could, in the opinion of the principal investigator, put the subject at undue risk.

 Have developed any other medical diseases (e.g., cardiopulmonary), laboratory abnormalities, or conditions (e.g., poor venous access) that in the opinion of the principal investigator, makes the subject unstable for the study.


Assessment of Oxidative Stress Markers in the Upper and Lower Airways of Atopic Children Treated With Nebulized Beclomethasone

Summary: Although it is well known that the presence of uncontrolled inflammation in upper airways may compromise the control of asthma and may favor the progression of asthma toward more severe grades of disease, few studies addressed whether therapies aimed to control both upper and lower airway inflammation may be more effective in controlling asthma. Markers of oxidative stress and of inflammation such as Nitrotyrosine and IL-5 are increased in the airways of children with atopic asthma and correlated with the levels of oral and nasal FeNO, and with the grade of atopy. We hypothesize that the treatment with Beclometasone nebulized with a facial mask (for treating both upper and lower airways) will be able to reduce the production of oxidants as well as of IL5 in both districts thus promoting clinical and functional improvements in mild intermittent asthmatic children. The results provided by this study will contribute to further clarify the relationship between nasal and bronchial inflammation.
Inclusion criteria: inclusion criteria:

 children with intermittent asthma and allergic rhinitis

Exclusion criteria: :

 children with acute respiratory symptoms in the last 4 weeks

 children with nasal polyposis or bronchial or respiratory tract infections

 children with a severe exacerbation of asthma resulting in hospitalization during the last month


Treatment of Viral Hemorrhagic Fevers With Intravenous Ribavirin in Military Treatment Facilities

Summary: This is a Phase 2 study of the safety and efficacy of Intravenous (IV) Ribavirin in treating patients presenting with a probable or suspected case of viral hemorrhagic fever (either Crimean Congo or Lassa Fever) at a military medical treatment hospital. All patients will be treated with a 10 day course of IV Ribavirin if they meet all the inclusion and none of the exclusion criteria.
Inclusion criteria: inclusion criteria:

 An individual will be enrolled in this study if the patient:

 Meets the case definition for a probable or a suspected case of CCHF or LF (see below).

 Has read and signed the Informed Consent.

 Is at least 18 years of age (17, if active military) and not greater than 65 years of age.

 Has a blood sample drawn and a type and cross-match ordered for transfusion.

 Agrees to collection of required specimens.

 Agrees to report any Adverse Events, Serious and Unexpected Adverse Events for the duration of the study.

 Agrees to a follow-up visit and to donate blood and urine specimens at day 14 (±2 days) and once between days 28 and 60 after the first dose of IV Ribavirin and to all follow-up visits for anemia or other medical conditions as required by the attending physician.

 Woman of childbearing age must have a pregnancy test performed. If negative, she must agree not to become pregnant during treatment and for 7 months after receiving Ribavirin. She also must agree to not breast feed during treatment and for 7 months after receiving Ribavirin. Two reliable forms of effective contraception must be used including one barrier method during treatment and during the 7 month post-treatment period. She will be counseled concerning the risks of IV Ribavirin versus no treatment if the pregnancy test is positive.

 Man agrees not to have intercourse with pregnant woman during treatment and for 7 months after receiving Ribavirin, and take precautions to avoid producing pregnancies during treatment and for 7 months after receiving Ribavirin. At least two reliable forms of effective contraception must be used including one barrier method during treatment and during the 7 month post-treatment period to avoid a pregnancy.

 Has a hemoglobin greater than or equal to10 g/dL before starting IV Ribavirin

 Note: Malaria should be excluded as a possibility for illness in patients suspected to have VHF.

 Probable Case of Crimean-Congo Hemorrhagic Fever:

 All subjects will have a history of possible exposure to CCHF, either having:

 Worked or slept outdoors in the CCHF endemic area within 2 weeks of illness onset, with or without a history of tick-bite or tick exposure, (Endemic area includes, but not necessarily limited to: Saudi Arabia, Kuwait, Oman, United Arab Emirates, Iran, Iraq, Turkey, Greece, Bulgaria, Albania, Montenegro, the Kosovo region of Serbia, Bosnia-Herzegovina, Macedonia, the whole of Africa, India, Pakistan, Afghanistan, Kazakhstan, Uzbekistan, Kyrgyzstan, Tajikistan, Turkmenistan, Azerbaijan, Georgia, the Crimean region of the Ukraine, Rostov-Don and Astrakhan regions of Russia, and the Xinjiang [northwestern] region of the People's Republic of China), OR

 Handled blood or freshly butchered meat of domestic livestock in CCHF endemic area during 2 weeks before the onset of illness, OR

 Had direct contact with blood, tissues, secretions, or excretions of a CCHF patient (suspected or confirmed), including laboratory specimens, OR

 Worked with the virus in the laboratory setting and have a clinical syndrome consistent with CCHF as defined by:

 Acute illness with fever and at least two of these symptoms: myalgia, low back pain, and headache,

 And the appearance of three or more of the following five groups of signs/symptoms:

 Hemorrhage (one or more petechiae, ecchymoses, purpura, gingival bleeding, epistaxis, gastrointestinal tract bleeding),

 Elevated AST levels (above the upper limits of normal for the laboratory),

 Thrombocytopenia (below the lower limits of normal),

 Hypotension (systolic pressure < 90 mm Hg), or

 Azotemia, renal failure (serum creatinine above the upper limits of normal).

 Prognostic indicators exist for subjects at increased risk of severe CCHF. Any of these indicators occurring in the first 5 days of illness, predict a mortality greater than 90% (Swanepoel et al., 1989). Patients with these prognostic indicators may benefit most from drug therapy, if resources become limiting:

 WBC > 10,000/mm3

 Platelet count < 20 x 103/mm3

 AST > 200 U/L

 ALT > 150 U/L

 APTT > 60 seconds

 Fibrinogen < 110 mg/dL

 Probable Case of Lassa Fever:

 All subjects will have a history of possible exposure to Lassa fever, either having:

 By residence or travel in an endemic area where contact with rodents was possible within 3 weeks of onset of illness, (Endemic area includes, but not necessarily limited to: Sierra Leone, Liberia, Nigeria, Mali, Central African Republic, and Guinea.) or

 Contact with a suspect patient or their body fluids (including laboratory specimens) within 3 weeks of symptom onset, or

 Worked with the virus in the laboratory setting. And have

 A negative malaria smear. And have

 Signs and symptoms compatible with Lassa fever, either:

 Fever plus pharyngitis plus retrosternal pain plus proteinuria (positive predictive value of 81% when these three criteria are met, McCormick et al., 1987a,b),OR

 Fever plus unexplained mucosal bleeding, OR

 Fever plus unexplained edema of the face and neck, OR

 Suspected Case of CCHF or LF

 Have a clinical syndrome consistent with CCHF or LF, meeting most of the above criteria of a probable case and the patient has an epidemiological history of potential exposure to the bunyavirus or arenavirus (i.e., recent field duty and/or other individuals in his troop have CCHF or LF).

Exclusion criteria: :

 Has known intolerance to Ribavirin.

 Is irreversibly ill on presentation, as defined by presence of profound shock (shock which does not respond to supportive therapy within 3 hours after admission).

 Has hemoglobin less than 10 g/dL that cannot be corrected to 10 g/dL before initiation of IV Ribavirin

 Has history of hemoglobinopathies (i.e., sickle-cell anemia or thalassemia major).

 Has history of autoimmune hepatitis.

 Has a calculated serum creatinine clearance of < 30 mL/min.

 History of such as second or third degree heart block or sick sinus syndrome and without a pacemaker and no capability of a pacemaker placement or Wolfe-Parkinson-White Syndrome.

 A sinus bradycardia of less than 40 beats per minute.

 Is currently being treated with Didanosine (ddI). ddI must be discontinued before starting IV Ribavirin.

 Relative

['Lassa Fever', 'Crimean-Congo Hemorrhagic Fever']

Lassa Fever
Crimean-Congo Hemorrhagic Fever


Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA)

Summary: The purpose of this study is to compare the effect of esomeprazole 20 or 40 mg once daily versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous low-dose acetylsalicylic acid.
Inclusion criteria: inclusion criteria:

 Daily intake of low-dose Aspirin (ASA) - The subject must fulfill at least one of the following (a-e):

 Aged ≥65 years.

 Aged ≥18 years and with a documented history of uncomplicated peptic ulcer(s).

 Aged ≥60 years and naïve to low-dose ASA (ie, treatment started within 1 month prior to randomization).

 Aged ≥60 years and with stable coronary artery disease.

 Aged ≥60 years and with complaints of upper gastrointestinal (GI) symptoms that, as judged by the investigator, requires an Esophagogastroduodenoscopy (EGD) and with the finding of ≥5 gastric and/or duodenal erosions at the baseline endoscopy.

Exclusion criteria: :

 Peptic ulcer(s) at baseline esophagogastroduodenoscopy (EGD).

 Reflux esophagitis Los Angeles (LA) classification grade C or D at baseline

 History of peptic ulcer complications such as clinically significant bleeding and/or perforation.

['Esomeprazole 40 mg', 'Esomeprazole 20 mg', 'Placebo']

Esomeprazole 40 mg
Esomeprazole 20 mg
Placebo


Triage of Reduced Exercise Tolerance in Frail Elderly

Summary: Background of the study:~Many elderly suffer from reduced exercise tolerance or exercise induced shortness of breath (dyspnoea) which causes decreased mobility and restrictions in physical, psychological and social functioning. Patients commonly attribute this symptom to their age, and simply adjust their life style to it. Reduced exercise tolerance/dyspnoea is very common with prevalence rate of 20-60% of those aged 65 years and over. The main causus in the elderly are heart failure and chronic obstructive pulmonary disease (COPD). Both diseases have a high negative impact on the quality of life and are associated with frequent hospital admissions. Over-diagnosis, but more often under-diagnosis of heart failure and COPD is rather common in primary care. Establishing a diagnosis early in the course of the disease is useful because both diseases can be adequately and evidence-based treated. Therefore, an easy diagnostic triage-strategy followed bij direct treatment would be of great importance to asses and treat heart failure and COPD in elderly patient with shortness of breath.~Objective of the study:~Quantify how many frail elderly aged over 65 years with reduced exercise tolerance and/or exercise induced dyspnoea have previously unrecognised COPD and heart failure. Quantify the difference in prevalence of unrecognised COPD and heart failure between those who underwent the diagnostic triage compared to those who received care as usual. Quantify the effect of the diagnostic triage plus the additionally treatment changes on functionality and quality of life after 6 months compared to those who received care as usual. Quantify the cost-effectiveness of the diagnostic triage strategy compared to care as usual~Study design:~A clustered randomized diagnostic (follow-up) study~Study population:~First, pre-selection of patients aged over 65 years from 50 general practices is based on frailty. Frailty is based on the next criteria: use 5 or more different types of medical drugs chronically in the last year and/or have 3 or more chronic or vitality treating diseases (such as diabetes mellitus, COPD, heart failure, impaired vision). This will be done from the electronic medical files of the general practices. These elderly will receive the MRC questionnaire of dyspnoea and three additional questions related tot exercise intolerance. Those with any dyspnoea and/or reduced exercise tolerance will be invited to participate, except those with established heart failure and COPD.~Study parameters/outcome of the study:~Prevalence of latent heart failure and COPD. Difference in prevalence of latent heart failure and COPD between both groups.~Differences in functionality and quality of life after 6 months between both groups. Cost-effectiveness and experienced patient burden of the diagnostic triage strategy.
Inclusion criteria: inclusion criteria:

 patients aged 65 years and older

 must have a minimum of three chronic or vitality threatening diseases and/or use five or more medical drugs chronically in the last year

 must have dyspnea and/or reduced exercise tolerance (scored by two short questionnaires)

Exclusion criteria: :

 patients with both confirmed COPD and heart failure (Spirometry performed < 1 year ago and heart failure confirmed by echocardiography)

 patients unable or unwilling to sign informed consent

['Heart Failure', 'Chronic Obstructive Pulmonary Disease']

Heart Failure
Chronic Obstructive Pulmonary Disease


Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For CAP

Summary: This is a prospective interventional study to assess laboratory testing which will identify the microbial cause of pneumonia. This, in turn, will allow targeted antimicrobial agent selection for patients with community acquired-pneumonia (CAP).~Hypothesis: 1) To determine if Targeted strategy is non-inferior to Empiric therapy with respect to outcome endpoints. 2) To assess the use of innovative POC tests allows targeted narrow-spectrum antimicrobial therapy. 3) To determine if Targeted strategy is superior to Empiric therapy in patients with viral pneumonia
Inclusion criteria: inclusion criteria:

 ● Adult patients greater than age 17 years who are initially evaluated in the ED with symptoms of CAP. This includes those who will be treated as outpatients and those admitted to the hospital (both ward and ICU).

 The definition of CAP is as follows:

 Presence of pulmonary infiltrates on chest radiography. (Initial reading may be performed by the ED physician - but has to be confirmed by board certified radiologist for inclusion in the study).

 At least 2 of the following: new onset of cough, productive sputum, shortness of breath, chest pain, fever > 380C, abnormal chest auscultation, WBC > 12,000 cells/mL.

 Able to provide informed consent

 Read, signed, and dated informed consent document

 Available for follow-up for the planned duration of the study

Exclusion criteria: :

 Patients with underlying immunosuppressive illness (HIV, neutropenia, asplenia, transplant recipient, cystic fibrosis, receipt of immunosuppressive medications including corticosteroids, (equivalent of prednisone > 10 mg) cancer chemotherapy, or anti-tumor necrosis factor agents.

 Patients residing in long-term care facilities

['Point-of-Care diagnostic laboratory test']


Utility of Serial BNP Levels in Emergency Department CHF

Summary: The purpose of the study is to determine if a series of BNP blood tests performed on patients who present to the Emergency Department with congestive heart failure (CHF) can predict which patients may have adverse outcomes. If the BNP is shown to be predictive of bad outcomes in certain patients, those patients might receive more intensive therapy early to prevent such outcomes. This was a prospective trial enrolling patients who presented to the ED and were diagnosed with heart failure. Subjects had a blood test for BNP, which is elevated in the presence of heart failure, collected twelve hours after their initial clinical BNP was obtained in the ED. Demographics, history, length of hospital stay, and other approved data were collected. At 30 days and 6 months after discharge, a follow up call was made to determine if the subject had required additional emergency care, had been admitted to a hospital, or had died during that period of time.
Inclusion criteria: inclusion criteria:

 age18 or older

 primary diagnosis of CHF in the Emergency Department

 admission to the hospital or transfer to the Observation Unit

Exclusion criteria: :

 minors, prisoners,pregnant women,unable to provide consent

 unstable angina or acute myocardial infarction in the ED

 dialysis dependent patients

 use of nesiritide as a therapy in the ED


Bioequivalency Study of 300 mg Lithium Carbonate Under Fasting Conditions

Summary: The objective of this study was the bioequivalence of a Roxane lithium carbonate 300 mg extended release tablet formulation compared to Solvay's Lithobid 300 mg extended release tablet under fasting conditions using a single-dose, randomized, 2 treatment, 2-period, 2-sequence crossover design.
Inclusion criteria: inclusion criteria:

 No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion criteria: :

 Positive test for HIV, Hepatitis B, or Hepatitis C.

 Treatment with known enzyme altering drugs.

 History of allergic or adverse response to lithium, or any comparable or similar product.


OlmeSartan and Calcium Antagonists Randomized (OSCAR) Study

Summary: The purpose of this study is to investigate whether high-dose angiotensin II receptor blocker (ARB) monotherapy or combination therapy with ARB and calcium channel blockers is more effective in reducing the incidence of cardiovascular events in Japanese elderly high-risk hypertensive patients not adequately controlled by standard dose ARB alone.
Inclusion criteria: inclusion criteria:

 Outpatients aged 65 years or older, and less than 85 years (at the time of informed consent), regardless of sex

 Current antihypertensive treatment with monotherapy

 SBP ≥ 140mmHg or DBP ≥ 90mmHg in a sitting position on two measurements on two clinic visits

 At least one of the following risk factors:

 Diabetes mellitus Type 2;

 History of cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient ischemic attack (more than 6 months before giving informed consent);

 Diagnosis of asymptomatic cerebrovascular disease;

 History of myocardial infarction (more than 6 months before giving informed consent);

 Diagnosis of angina pectoris or heart failure (New York Heart Association [NYHA] functional classification I or II);

 Diagnosis of left ventricular hypertrophy (thickness of the wall of interventricular septum ≥ 12mm on echocardiography or Sv1+Rv5 ≥ 35mm on electrocardiography before informed consent);

 Diagnosis of aortic aneurysm;

 History of aortic dissection (more than 6 months before giving informed consent);

 Diagnosis of arteriosclerotic peripheral arterial obstruction (Fontaine classification from 2 to 4);

 Serum creatinine: 1.2-2.5mg/dL (male); 1.0-2.5mg/dL (female);

 Proteinuria: ≥ +1 (or ≥ 0.3g/g･Cr. estimated from 24-hour urine collection or random urinary protein corrected by urine creatinine).

Exclusion criteria: :

 Secondary hypertension or malignant hypertension

 Heart failure (NYHA functional classification III or IV)

 Required treatment for malignant tumor

 Serious liver or renal dysfunction (serum creatinine > 2.5mg/dL or with dialysis treatment)

 Not appropriate for change to the test drugs from current therapy for hypertension or coronary diseases (i.e. calcium channel blockers, β-blockers, thiazide diuretics, etc.)

 History of serious adverse drug reactions to angiotensin II receptor blockers or calcium channel blockers

 Patients with other serious reasons (i.e. illness, significant abnormalities, etc.) that investigators judge inappropriate for the study

['Olmesartan medoxomil', 'Calcium channel blockers (amlodipine, azelnidipine)']

Olmesartan medoxomil
Calcium channel blockers (amlodipine
azelnidipine)


Methylphenidate for Attention Problems After Pediatric TBI

Summary: Traumatic Brain Injury (TBI) - methylphenidate treatment
Inclusion criteria: inclusion criteria:

 Between ages of 6-17

 Sustained Moderate to Severe TBI

 TBI occurred at least 6 months prior to beginning the study

 TBI occurred no earlier than 5 years of age

 Positive endorsement of 6 out of 9 items on the Vanderbilt ADHD inattention or hyperactivity scale

Exclusion criteria: :

 History of developmental disability or mental retardation

 Current active participation in ADHD-related behavioral intervention

 History of psychiatric condition requiring an inpatient admission in past 12 months

 Actively taking medications with a contraindication to Concerta that cannot be discontinued

 Current use of stimulant medication or ADHD specific medications that cannot be discontinued

 Non-blunt head injury

 Family history of arrhythmia

 Pregnancy

['Traumatic Brain Injury', 'TBI', 'ADHD']


Bupropion and Weight Control for Smoking Cessation - 1

Summary: The purpose of this study is to determine whether the addition of bupropion (Zyban) to cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.
Inclusion criteria: inclusion criteria:

 Smoke at least 10 cigarettes per day

 Report concern about cessation-related weight gain

 Motivated to quit smoking

Exclusion criteria: :

 Currently pregnant, lactating, or no medically approved method of contraception

 Major medical problem

 History of seizure disorder or head injury

 Current or historical psychosis or bipolar disorder

 History of alcohol or substance abuse within previous year

 Current or historical eating disorder

 Use of antidepressant medication, monoamine oxidase inhibitor or lithium with previous month

 Multiple Drug Allergies

 Current major depressive disorder

['Bupropion', 'Placebo', 'weight concerns intervention', 'smoking cessation intervention']

Bupropion
Placebo
weight concerns intervention
smoking cessation intervention


Genetic Biomarkers in Tissue Samples From Patients With Osteosarcoma

Summary: This clinical trial studies genetic biomarkers in tissue samples from patients with osteosarcoma. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer
Inclusion criteria: inclusion criteria:

 Samples from the COG tissue repository
Exclusion criteria:


Zambia Integrated Management of Malaria and Pneumonia Study

Summary: The purpose of the study is to demonstrate the effectiveness and feasibility of community-based management of pneumonia and malaria by community health workers (CHWs) in a rural district of Zambia.
Inclusion criteria: inclusion criteria:

 Age between 6 months and 5 years

 Present with history of fever or reported fever

 Present with cough or difficult breathing

Exclusion criteria: :

 Age below 6 months and above 5 years

 Presence of signs and symptoms of severe illness


Development of an Insomnia Treatment for Depressed Adolescents

Summary: Major depressive disorder (MDD) occurs at least 11% of adolescents and approximately 53-90% of those adolescents have insomnia. If left untreated, insomnia increases the risk of relapse and recurrence of depressive episodes, unintentional injuries, poor school performance, substance use, obesity, and the risk for suicide. This project seeks to develop a nonpharmacological treatment for insomnia in adolescents with depression that is feasible and effective. The specific methodologies that will help accomplish these results are: 1) use of focus groups of adolescents with depression and insomnia to determine how the current standard, nonpharmacological treatment for insomnia (cognitive-behavioral therapy for insomnia; CBTI) among adults can be modified for use by adolescents with depression and 2) determine the preliminary effectiveness, feasibility, and tolerability of group CBTI in adolescents with depression (CBTI-AD) developed using feedback from the focus groups. This project will help to improve the quality and scope of delivery of mental health services in Michigan by a) gaining a greater understanding of how sleep disturbance may perpetuate depression in adolescents and b) to provide mental health professionals with a nonpharmacological treatment option for insomnia in adolescents with depression.
Inclusion criteria: inclusion criteria:

 Between 13-19 years of age

 Are depressed

 Have insomnia

Exclusion criteria: :

 Are not depressed

 Do not have insomnia

 Currently using a sleep aid

 Have bipolar depression

 Have psychotic disorder

 Have a sleep disorder other than insomnia

['Cognitive Behavioral Therapy for Insomnia']


Clinical Research for the Diagnosis of Tick-borne Diseases in Patients With Unexplained Acute Fever

Summary: The study will use several laboratory diagnoses in the diagnosis of patients with fever，to find out which will be more helpful for making an accurate diagnosis in the early period of Tickborne Diseases.
Inclusion criteria: inclusion criteria:

 patients have fever more than one week

 temperature is higher than 38℃ Celsius degree

 full of physical examination and laboratory examination have been carried out after one week，but still cannot make a definite diagnosis

Exclusion criteria: :

 fever for non-infectious diseases such as rheumatic autoimmune disease or with tumor

 we find that the patient selected does not meet the selection criteria within the observation period

 patients leave with automatic discharge

['Fever of Unknown Origin', 'Tick-borne Diseases']

Fever of Unknown Origin
Tick-borne Diseases


BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy.

Summary: This single arm study will assess participant preference for monthly Bonviva, versus daily or weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis. Participants currently on a daily or weekly regimen of bisphosphonate therapy (alendronate or risedronate) will answer a questionnaire to identify participants who may benefit from a monthly Bonviva regimen. Eligible participants will then discontinue their present bisphosphonate treatment, and switch to monthly Bonviva 150mg per oral (po). At the beginning and end of Bonviva treatment, all participants will complete an Osteoporosis Patient Satisfaction Questionnaire. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Inclusion criteria: inclusion criteria:

 post-menopausal women;

 >=3 months daily or weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis.

Exclusion criteria: :

 inability to stand or sit in an upright position for at least 60 minutes;

 hypersensitivity to bisphosphonates;

 treatment with other drugs affecting bone metabolism;

 abnormalities of the oesophagus, which delay oesophageal emptying.


Use of Radiofrequency Ablation to Eliminate Continuous Atrial Fibrillation in Patients Undergoing Mitral Valve Surgery

Summary: The aim of this prospective randomized clinical trial was to evaluate the early and late outcome following left atrial radiofrequency ablation during MV surgery for the treatment of continuous atrial fibrillation and to assess the functional effects of restoration of sinus rhythm.
Inclusion criteria: inclusion criteria:

 Patients requiring MV surgery with at least 6 month history of atrial fibrillation

Exclusion criteria: :

 Patients with sick sinus syndrome

 Hyperthyroidism

 Permanent pacemaker

 Previous cardiac surgery

['Atrial Fibrillation', 'Radiofrequency Catheter Ablation']

Atrial Fibrillation
Radiofrequency Catheter Ablation


Safety and Efficacy of Olopatadine 0.6% and Azelastine 137 Mcg in Vasomotor Rhinitis

Summary: The purpose of this study is to examine safety and efficacy of Patanase and Astelin in treating the symptoms of non-allergic vasomotor rhinitis (VMR).
Inclusion criteria: inclusion criteria:

 Diagnosis of VMR with at least 2 years of chronic non-allergic rhinitis

 Negative skin tests to a panel of allergens and positive histamine test within last 2 years

 History of symptoms related to defined VMR triggers

Exclusion criteria: :

 Nasal disorder, surgery, or concurrent disease that could interfere with evaluation of study medications

 Bacterial or viral infection within 14 days of first visit. Diagnosis of acute sinusitis within 30 days of first visit

 Chronic use of drugs that can cause rhinitis

['Olopatadine HCL (Patanase) Nasal Spray, 0.6%', 'Azelastine HCl (Astelin) Nasal Spray, 137 mcg']

Olopatadine HCL (Patanase) Nasal Spray
0.6%
Azelastine HCl (Astelin) Nasal Spray
137 mcg


A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations

Summary: This study will determine whether patients who have been infected with the Lyme bacteria, Borrelia burgdorferi, and treated with antibiotics still have the bacteria alive inside them and whether it is causing their symptoms. The information from this study may serve as a basis for developing stringent diagnostic criteria for Lyme disease and the establishment of future treatment trials.~Individuals in the following categories may be eligible for this study: chronic Lyme disease; chronic Lyme arthritis; seropositive control (are infected with the bacteria that causes Lyme disease but do not have disease symptoms); recovered control (have been sick with Lyme disease but were treated successfully and are currently well); control with multiple sclerosis (patients with multiple sclerosis); and healthy volunteers. Patients in the chronic Lyme disease category must be age 13 and above; all others must be age18 and above. Candidates will be screened with blood and urine tests.~Participants will have a physical examination and the following tests:~Blood tests Includes HLA-typing, a genetic test of immune system markers;~Leukapheresis Collection of large numbers of white blood cells Whole blood is collected through a needle in an arm vein. The blood circulates through a machine that separates it into its components. The white cells are removed and the rest of the blood is returned to the body, either through the same needle used to draw the blood or through another needle in the other arm. (Alternatively, patients will 100 cc (about 7 tablespoons) of blood drawn.);~Lumbar puncture (spinal tap) Collection of cerebrospinal fluid (CSF, fluid that bathes the brain and spinal cord). A local anesthetic is administered and a needle is inserted in the space between the bones in the lower back where the cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is collected through the needle;~Magnetic resonance imaging (MRI) of the brain Imaging of the brain using a strong magnetic field and radio waves instead of X-rays. During the scan, the patient lies on a table in a narrow cylinder containing a magnetic field. He or she can speak with a staff member via an intercom at all times during the procedure;~Neuropsychologic testing;~Some participants may also have a hearing test and urine collection.~Participants whose test results are positive for Borrelia burgdorferi will be followed at NIH at intervals of 3 to 6 months until it is determined whether there is infection. Those who are infected will be offered treatment with the antibiotic ceftriaxone. Following treatment, patients will return to the NIH Clinical Center for follow-up visits 1 week after treatment and again at 3, 6 and 12 months. The lumbar puncture, hearing examination, blood and urine tests will be repeated at these visits to evaluate the response to treatment, and the leukapheresis will be repeated for research purposes. Patients whose MRI was abnormal during therapy will have a repeat MRI at the 3-month, 6-month and 1-year visits.~All participants with chronic Lyme disease, chronic Lyme arthritis, seropositive controls and recovered controls may be reevaluated at intervals of 6 to 12 months.
Inclusion criteria: inclusion criteria:

 SCREENING FOR SUSPECTED PTLDS

 Age >= 13 years old, suspect of suffering from Lyme disease

 POST-TREATMENT LYME DISEASE SYNDROME (PTLDS)

 For the purposes of this study, PTLDS is defined as (1) occurring in male or female patients aged 13 and above (2) who have been diagnosed with confirmed or probable Lyme disease per CDC definition (https://wwwn.cdc.gov/nndss/conditions/lyme-disease/case-definition/2017/). Study physician will review history to confirm probable cases. (3) They have received recommended antibiotic therapy (4) and have persistent or relapsing symptoms and/or signs for at least six months after therapy [4, 5]. (5) They also should have no other documented explanation for their signs and symptoms.

 LYME ARTHRITIS CONTROLS

 For the purposes of this study, Lyme arthritis is defined as occurring in an otherwise healthy male or female aged 18 and above who have intermittent episodes of arthritis involving one or few joints, without any other cause being documented, and have positive serum antibodies to B. burgdorferi confirmed by IgG Western blot according to the CDC criteria.

 RECOVERED CONTROLS

 For the purposes of this study, a recovered control is defined as an otherwise healthy male or female aged 18 and above who has had confirmed or probable Lyme disease, fulfilling the CDC Lyme Disease National Surveillance Case Definition (appendix 5), and who had received accepted antibiotic treatment for Lyme disease [5] (at least 3 months since the end of antibiotic therapy before protocol evaluation) and who are currently asymptomatic.

 SEROPOSITIVE CONTROLS

 For the purposes of this study, a seropositive control is defined as an otherwise healthy male or female aged 18 and above who has positive serum IgG antibody response to B. burgdorferi by Western blot according to the CDC criteria and are asymptomatic and who recall no episodes of disease compatible with Lyme infection and have not received antibiotic therapy for Lyme

 disease.

 OSPA VACCINATED CONTROL

 For the purposes of this study, an OspA vaccinated control is defined as an otherwise healthy male or female age 18 and above who has received at least two doses of the OspA vaccine for Lyme disease (Lymerix ). These controls may have a positive ELISA for B. burgdorferi but a negative (or unreadable) IgG western blot.

 MULTIPLE SCLEROSIS CONTROLS

 For the purposes of this study, a multiple sclerosis control is defined as an otherwise healthy male or female aged 18 and above with relapsing-remitting or progressive multiple sclerosis as defined by the Clinical Trial Committee of the National Multiple Sclerosis Society and no evidence of prior exposure to B. burgdorferi as indicate by negative history for Lyme disease and negative western blot for B. burgdorferi in the serum by the CDC criteria. Patients should have a Kurtzke or Expanded Disability Status Scale (EDSS) between 1 and 5.

 HEALTHY VOLUNTEERS

 For the purpose of this study, a healthy volunteer is defined as healthy male or female, age 18 and above, with no history compatible with Lyme disease and negative serological testing to B. burgdorferi by the CDC criteria.

 GENERAL
Exclusion criteria:

 Age less than 18 (less than 13 for patients with PTLDS)

 Weight less than 70 Lb. (35 kg)

 Pregnancy or lactation

 Women with childbearing potential who are sexually active with a male partner and unwilling to use effective contraception during the evaluation and treatment phases of the protocol.

 Clinically significant laboratory abnormalities including positive test for syphilis (RPR), HBsAg, anti-HCV, anti-HIV.

 Chronic medication use will be evaluated in a case-by-case basis.

 Not able to understand all of the requirements of the study or unable to give informed consent and/or comply with all aspects of the evaluation.

 All study participants must agree to allow their samples to be used for future research.


Parathyroid Reimplantation in Forearm Subcutaneous Tissue During Thyroidectomy: a Simple Way to Avoid Ipoparathyroidism and Evaluate Graft Function

Summary: The purpose of this study is to evaluate safety and effectiveness of normal parathyroid tissue reimplantation in forearm subcutaneous tissue in case of accidental removal of parathyroid gland during thyroid surgery.
Inclusion criteria: inclusion criteria:

 Patients affected by benign thyroid disease undergoing thyroidectomy
Exclusion criteria:

['Thyroidectomy and parathyroid reimplantation in forearm subcutaneous tissue']

['Thyroid Goiter', 'Thyroid Carcinoma', 'Multinodular Goiter', 'Graves Diseases']

Thyroid Goiter
Thyroid Carcinoma
Multinodular Goiter
Graves Diseases


Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP)

Summary: The purpose of this randomized, double-blind, Phase III trial is to determine if the combination of eflornithine plus sulindac is superior to sulindac or eflornithine as single agents in delaying time to the first occurrence of any FAP-related event. This includes: 1) FAP related disease progression indicating the need for excisional intervention involving the colon, rectum, pouch, duodenum and/or 2) clinically important events which includes progression to more advanced duodenal polyposis, cancer or death.
Inclusion criteria: inclusion criteria:

 Diagnosis of phenotypic classical FAP with disease involvement of the duodenum and/or colon/rectum/pouch.

 Genotype: Adenomatous polyposis coli (APC) mutation (with or without family history) required

 Classical FAP Phenotype: 100's to 1,000's of colorectal adenomatous polyps, usually appearing in teenage years

 Upper gastrointestinal (UGI) endoscopy/ lower gastrointestinal (LGI) endoscopy (proctoscopy/colonoscopy) performed within 30 days of randomization.

 Patients with an intact colon/rectum, except for clinical polyposis, and prophylactic surgery is being considered as a stratification site.

 Rectal/pouch polyposis as a stratification site as follows:

 At least three years since colectomy with ileorectal anastamosis (IRA)/proctocolectomy with pouch, and demonstrating polyposis as defined by Stage 1, 2, 3, of the proposed InSiGHT 2011 Staging System (Appendix B) and summarized as follows:

 Stage 1: 10-25 polyps, all < 5 mm Stage 2: 10-25 polyps, at least one > 1 cm Stage 3: >25 polyps amenable to complete removal, or any incompletely removed sessile polyp, or any evidence of high grade dysplasia, even if completely removed. [Note: For staging purposes only.]

 For all subjects, any rectal/pouch polyps > 5 mm must be excised at baseline.

 Duodenal polyposis as a stratification site; one or more of the following:

 Current Spigelman Stage 3 or 4.

 Prior surgical endoscopic intervention within the past six months for Spigelman Stage 3 or 4 that may have been down staged to Spigelman Stage 1 or 2.

 Hematopoietic Status (within 30 days prior to randomization):

 No significant hematologic abnormalities

 White blood cell count (WBC) at least 3,000/mm3

 Platelet count at least 100,000/mm3

 Hemoglobin at least 10.0 g/dL

 No history of clinical coagulopathy

 Hepatic Status (within 30 days prior to randomization):

 Bilirubin no greater than 1.5 times ULN

 Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) no greater than 1.5 times ULN

 Alkaline phosphatase no greater than 1.5 times ULN

 Renal Status (within 30 days prior to randomization):

 a) Creatinine no greater than 1.5 times ULN

 Hearing:

 a) No clinically significant hearing loss, defined in Section 6.2, number 9.

 If female, neither pregnant nor lactating.

 Negative pregnancy test if female of child-bearing potential. Fertile patients must use effective contraception*.

 Absence of gross blood in stool; red blood on toilet paper only acceptable.

 No discrete gastric or duodenal ulcer greater than 5 mm within the past year except Helicobacter pylori-related peptic ulcer disease treated with antibiotics.

 No invasive malignancy within the past 5 years except resected non-melanomatous skin cancer, papillary thyroid cancer, or precancerous cervical dysplasia.

 No other significant medical or psychiatric problems that would preclude study participation or interfere with capacity to give informed consent.

 Use of 81-100 mg daily aspirin or up to 700 mg aspirin not more than once a week are eligible.

 No concurrent warfarin, fluconazole, lithium, Pradaxa® or other direct thrombin inhibitors, Plavix®, cyclosporine, other NSAIDs (such as ibuprofen, aspirin, diflunisal), diuretics (furosemide and thiazides), dimethylsulfoxide (DMSO), methotrexate, probenecid, propoxyphene hydrochloride, Tylenol® (acetaminophen) preparations containing aspirin or cytotoxic chemotherapy drugs.

 Willingness to forego concurrent use of supplements containing omega-3 fatty acids, corticosteroids, non-steroidal anti-inflammatory drugs or other FAP directed drug therapy.

 Able to provide informed consent and follow protocol requirements.

Exclusion criteria: :

 Prior pelvic irradiation.

 Patients receiving oral corticosteroids within 30 days of enrollment.

 Treatment with other investigational agents in the prior 4 weeks.

 Use of other non-steroidal anti-inflammatory drugs (such as ibuprofen) exceeding 4 days per month, in the prior 6 weeks.

 Regular use of aspirin in excess of 700 mg per week.

 Treatment with other FAP directed drug therapy (including sulindac or celecoxib, fish oil) within 12 weeks of study enrollment.

 Hypersensitivity to cyclooxygenase-2 inhibitors, sulfonamides, NSAIDs, or salicylates; NSAID associated symptoms of gastritis.

 Patients must not have cardiovascular disease risk factors as defined below:

 Uncontrolled high blood pressure (systolic blood pressure > 150 mm Hg

 Unstable angina

 History of documented myocardial infarction or cerebrovascular accident

 New York Heart Association Class III or IV heart failure

 Known uncontrolled hyperlipidemia defined as LDL-C >= 190 mg/dL or triglycerides >= 500 mg/dL

 Patients with significant hearing loss are not eligible for study participation defined as hearing loss that affects everyday life and/or for which a hearing aid is required.

 Colon/rectum/pouch with high grade dysplasia or cancer on biopsy or a large polyp (>1 cm) not amenable to complete removal.

 Duodenal cancer on biopsy.

 Intra-abdominal desmoid disease, stage III or IV

 Inability to provide informed consent.

['Eflornithine', 'Eflornithine Placebo', 'Sulindac 150 MG', 'Sulindac placebo']

Eflornithine
Eflornithine Placebo
Sulindac 150 MG
Sulindac placebo


Analysis of Hypovitaminosis D and Osteopenia/Osteoporosis in Spinal Disease Patients Who Underwent a Spinal Fusion at Illinois Neurological Institute, Peoria, IL., a Retrospective Review From November 1, 2012 to October 31, 2014 and Prospective Pilot From July 1, 2015-June 30, 2016

Summary: The purpose of this study is to determine if there is correlation between Vitamin D deficiency and spinal disease/spinal fusion surgery.
Inclusion criteria: (Part 1, Retrospective Study)

 inclusion criteria:

 50 years old or older.

 Patients with any form of spinal fusion surgery performed by Dr. Daniel Fassett, MD, MBA, Neurosurgeon at OSF-INI from November 1, 2012 to October 31, 2014.

Exclusion criteria: :

 Subjects diagnosed with chronic renal disease Stage IV or V, metastatic spinal disease, bariatric surgery, malabsorption syndrome, seizure medication and chronic steroid use greater than 3 months at time of surgery.

 (Part 2, Observational Study)

 (Screening period July 1, 2015-June 30, 2016)

 inclusion criteria:

 50 years old or older.

 Serum Vitamin D level checked prior to or at surgery.

 BMD exam performed anytime within 2 years prior to surgery.

 Patients with any form of spinal fusion cervical, thoracic, lumbar, surgery performed by Dr. Daniel Fassett, MD, MBA, Neurosurgeon at OSF-INI from July 1, 2015 to May 31, 2016.

['Hypovitaminosis D', 'Spinal Disease', 'Osteoporosis']

Hypovitaminosis D
Spinal Disease
Osteoporosis


Evaluation of the Safety and Effectiveness of the Akreos MI Five-0 Intraocular Lens.

Summary: The objective of this 12-month clinical investigation is to evaluate the safety and effectiveness of the Bausch & Lomb Akreos MI Five-O intraocular lens (IOL). Effectiveness will be shown through the demonstration of accurate distance correction and safety will be demonstrated through the monitoring of adverse events.
Inclusion criteria: inclusion criteria:

 Subjects must have a clinically documented diagnosis of age-related cataract.

 Subjects must have clear intraocular media other than cataract.

 Subjects must be undergoing primary in-the-bag intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.

Exclusion criteria: :

 Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.

 Subjects with diagnosis of degenerative visual disorder.

 Subjects who have any inflammation or edema (swelling) of the cornea.

 Subjects with immunodeficiency disorders.

 Subjects who have had previous intraocular surgery in the study eye.

 Subjects with incomplete/damaged zonule, or with conditions associated with increased risk of zonular rupture.

 Subjects with chronic use of systemic steroids or immunosuppressive medications.


Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation

Summary: In this pilot and feasibility study, the investigators will enroll patients with frequent symptomatic episodes of atrial fibrillation (AF) in a cross-over study testing two different classes of anti arrhythmic drugs (AADs). This pilot and feasibility study will provide preliminary data for a larger study in which the investigators will test the hypothesis that a common AF genetic risk allele modulates response to different AADs.
Inclusion criteria: inclusion criteria:

 ≥ 18 years of age

 Patients of African, European, and Hispanic descent

 History of typical or early-onset symptomatic (≥2 episodes/month) paroxysmal/persistent AF

 ECG that was recorded within 1 month of randomization showing AF

 Eligible for both Flecainide(Class I) and Sotalol (Class III) AAD

 Able to give informed consent

Exclusion criteria: :

 Permanent AF or isolated atrial flutter

 Cardiac or thoracic surgery within the previous 6 months

 Previous use of amiodarone other than short-term use (e.g. for an acute arrhythmia in hospital)

 Medical condition that is likely to be fatal in less than one year

 A history of prior AF ablation

 Have already been tried on 2 or more AADs in the past for AF

 Creatinine clearance <40 ml/min

 Left ventricular ejection fraction < 50%

 Contra-indication to a Class I AAD e.g., structural heart disease, or history of MI

 Contra-indication to a Class III AAD, e.g., congenital or acquired long QT syndrome with QTc>480 ms in females and >460 ms in males at baseline

 A reversible cause of AF (e.g., hyperthyroidism)

 Females who are pregnant or nursing

 History of severe AV node dysfunction unless an electronic pacemaker is present

 First- or second-degree relative has already participated in the study

 Unable to adhere to study procedures that are strictly for research purposes


Transfusion in Gastrointestinal Bleeding

Summary: Aim: To evaluate the feasibility and safety of a restrictive versus liberal red blood cell (RBC) transfusion policy in adult patients admitted with Acute Upper Gastrointestinal Bleeding (AUGIB) in order to inform the design of a definitive phase III randomised controlled trial.
Inclusion criteria: inclusion criteria:

 Adults aged 18 or over years presenting with AUGIB, defined by haematemesis or melaena.

Exclusion criteria: :

 Patients with whom the responsible clinician considers there is a need for immediate RBC transfusion prior to obtaining or regardless of the initial Hb result due to severity of bleeding.

 Existing hospital in-patients who develop AUGIB.

['Restrictive transfusion policy', 'Liberal Transfusion Policy']

Restrictive transfusion policy
Liberal Transfusion Policy


IMAGE-HF Project I-A: Cardiac Imaging in Ischemic Heart Failure (AIMI-HF)

Summary: Medical imaging is one of the fastest growing sectors in health care and increases in utilization underscore the need to ensure imaging technology is developed and used effectively. Evaluation of the clinical and economic impact of such imaging lags behind the technology development. Heart failure (HF) represents the final common pathway for most forms of heart disease and morbidity and mortality remain high. There is a need to identify imaging approaches that have a positive impact on therapy decisions, patient outcomes and costs. As well as standard methods to evaluate new and emerging techniques to better test their potential in a clinical management setting.~PRIMARY OBJECTIVES: to compare the effect of HF imaging strategies on the composite clinical endpoint of cardiac death, MI, resuscitated cardiac arrest and cardiac re-hospitalization (WHF, ACS, arrhythmia). Patients with an ischemic heart disease (IHD) etiology will follow HF imaging strategy algorithms according to the question(s) asked by the physicians (is there ischemia and/or viability), in agreement with their local practices for standard and alternative imaging.~SECONDARY OBJECTIVES:~To evaluate the effect of imaging modalities within and between the imaging subgroups (advanced (CMR and PET), PET, MRI and standard (SPECT)) on the primary and secondary outcomes in patients being evaluated either for viability and/or ischemia.~To evaluate the impact of adherence to recommendations between modalities on outcomes in patients being evaluated for either viability or ischemia.~To compare the effect of HF imaging strategies on:~The incidence of revascularization procedures (PCI, CABG, none) and the interaction of the imaging strategy and types of revascularization on outcomes~LV remodeling: LV volumes, LVEF,~HF symptoms, NYHA class~QOL (MLHFQ, the EQ5D)~The evolution of serum prognostic markers in HF (e.g. BNP, RDW, hs-cTnT, hs-CRP, ST2)~Health economics: Costs estimated through regression analysis and cost effectiveness assessed through decision modeling.~The safety of imaging tests measured by cumulative radiation, adverse reactions to imaging contrast agents and stress testing agents will also be determined.~The evolution of renal function (eGFR) and LV remodeling-associated biomarkers (e.g. PIIINP, OPN).~Event rates of each component of the composite endpoint as well as the combined endpoint of CV death and HF hospitalization~All-cause mortality
Inclusion criteria: inclusion criteria:

 Age >18 years

 Known or highly suspected coronary artery disease (CAD) documented by coronary angiography or by history of previous MI or evidence of moderate ischemia or scar based on prior imaging

 LV dysfunction most likely attributable to ischemic heart disease with EF <45% measured by any acceptable means (echo, nuclear RNA, PET or SPECT perfusion, Angiography, Cardiac MR) within the previous 6 months AND NYHA class II-IV symptoms within the past 12 months.

 OR

 LV dysfunction most likely attributable to ischemic heart disease with EF ≤30% measured by any acceptable means (echo, nuclear RNA, PET or SPECT perfusion, Angiography, Cardiac MR) within the previous 6 months AND NYHA class I within the past 12 months

Exclusion criteria: :

 Severe medical conditions that significantly affect the patient's outcome (eg. severe COPD, active metastatic malignancy) and would preclude revascularization.

 < 4 weeks post ST segment elevation myocardial infarction (STEMI)

 Already identified as not suitable for revascularization;

 Emergency revascularization indicated

 Severe valvular heart disease requiring surgery

 Contraindications to CMR (eg metallic implant, claustrophobia, renal failure (GFR <30 ml/min/1.73m2),). However patients with permanent pacemakers or implanted defibrillators or GFR <30 ml/min/1.7m2, will be randomized only to standard imaging (SPECT) versus PET or entered into the registry if only 1 modality is available

 Pregnancy

 Potential for non compliance to tests involved in this protocol

 Incapacity to provide informed consent

['Advanced cardiac imaging', 'Standard Cardiac Imaging']

Advanced cardiac imaging
Standard Cardiac Imaging

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

Heart Failure
Coronary Artery Disease
Ischemic Cardiomyopathy


Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders

Summary: The primary goal of this study is to investigate metabolic changes and maintaining efficacy in stabilized patients with bipolar disorders who have pharmacologically induced weight gain.
Inclusion criteria: inclusion criteria:

 patients with bipolar disorders (I, II, NOS) diagnosed with DSM-IV criteria

 age between 18 and 65

 Decisional capacity is adequate to provide informed consent or has an authorized appropriate surrogate decision maker. in a syndromal remission state at least for 2 months : CGI - BP ≤ 3

 patients who have exhibited a clinically significant increase in body weight after starting the administration of their current antipsychotic (ie >7% weight gain)

Exclusion criteria: :

 diagnosis of eating disorder, substance abuse, and psychotic disorder

 history of neurological and medical illness

 pregnant or breast feeding women

['Bipolar Disorders', 'Metabolic Complication']

Bipolar Disorders
Metabolic Complication


Psilocybin Cancer Anxiety Study

Summary: The primary objective of this double-blind, placebo-controlled pilot study is to assess the efficacy of psilocybin administration (4-phosphoryloxy-N,N-dimethyltryptamine), a serotonergic psychoactive agent, on psychosocial distress, with the specific primary outcome variable being anxiety associated with cancer. Secondary outcome measures will look at the effect of psilocybin on symptoms of pain perception, depression, existential/psychospiritual distress, attitudes towards disease progression and death, quality of life, and spiritual/mystical states of consciousness. In addition, a secondary objective of the study is to determine the feasibility of administering psilocybin to this patient population, with regards to the following issues: safety, patient recruitment, consent for treatment, and retention. The duration of the proposed investigation will be long enough to administer the drug one time to each of thirty-two patients and to conduct follow-up assessments. This study is separate but similar to a recently completed study at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, run by a psychiatrist, Dr. Charles Grob. Although the outcomes measures would be similar to those used as in the Grob study, the proposed dose of psilocybin is higher at 0.3mg/kg and the total subjects for the study would be 32 instead of 12. The study utilizes a cross-over design at 7 weeks and includes prospective follow-up of 6 months duration. This study has been approved by the Bellevue Psychiatry Research Committee, the NYU Oncology PRMC Committee, the Food and Drug Administration (FDA) through the issuance of an IND (77,138), the New York University School of Medicine Institutional Review Board (NYU IRB), the Health and Hospitals Corporation (HHC)-New York University (NYU) Clinical Translational Science Institute (CTSI), the NYU Bluestone Center for Clinical Research, and the Drug Enforcement Agency (DEA) through the issuance of a schedule I license.~It is hypothesized that a one time experience with psilocybin will occasion dramatic shifts in consciousness and awareness that will lead to short-term (ie hours to days) and long-term (up to 6 months in this study, following the administration of the second dosing, either psilocybin or placebo) improvement in anxiety, depression, and pain associated with advanced cancer. The exact mechanism of action is unclear but based on studies done in the 60's using serotonergic hallucinogens in patients with advanced cancer, improvements in anxiety levels, mood and pain were reported. However, a treatment model developed by the famous British psychiatrist Humphrey Osmond, offers one possibility. In this model, serotonergic hallucinogens' therapeutic mechanism lies in their ability to allow the individual to access novel dimensions of consciousness and their efficacy or lack thereof relies on whether a transcendent and mystical state of awareness is attained. Another possible mechanism relates to what Dobkin de Rios and Grob have described as 'managed altered states of consciousness,' where the power of suggestibility, occurring in a safe setting, allows one to transcend a particular state of consciousness (i.e. anxiety and depression associated with advanced illness) as a means to facilitate emotional discharge and to manage irreconcilable conflict.
Inclusion criteria: inclusion criteria:

 Age: 18-76

 Current or historical diagnosis of cancer

 Projected life expectancy of at least one year

 DSM-IV diagnoses: Acute Stress Disorder, Generalized Anxiety Disorder, Anxiety Disorder due to cancer, Adjustment Disorder with anxious features

 Any stage of cancer diagnosis

Exclusion criteria: :

 Epilepsy

 Renal disease

 Diabetes

 Abnormal liver function

 Severe cardiovascular disease

 Malignant Hypertension

 Baseline blood pressure must be less than or equal to 140/90

 Personal history or immediate family members with schizophrenia, bipolar affective disorder, delusional disorder, schizoaffective disorder or other psychotic spectrum illness

 Current substance use disorder

 Medication contraindications: anti-seizures medications, insulin, oral hypoglycemics, clonidine, aldomet, cardiovascular medications, anti-psychotics (first and second generation), anti-depressants and mood stabilizers


Tick-Borne Encephalitis (TBE) Seropersistence After First Booster and Response to a Second Booster in Children, Adolescents and Young Adults (Follow-Up to Study 700401)

Summary: The main purpose of this study is to assess the seropersistence of TBE virus antibodies in children, adolescents and young adults who received the first booster vaccination with either FSME-IMMUN 0.25 mL Junior or FSME-IMMUN 0.5 mL in precursor Study 700401.
Inclusion criteria: inclusion criteria:

 Subjects who participated in precursor Study 700401 and meet ALL of the following criteria are eligible for participation in this study:

 Subject / parent(s) / legal guardian(s) provide(s) written informed consent (according to national law);

 Subject provides written assent to the study according to age and capacity of understanding;

 Subject received the first booster vaccination with either FSME-IMMUN 0.25 ml Junior or FSME-IMMUN 0.5 ml during the course of precursor Study 700401;

 Blood was drawn after the first booster vaccination in precursor Study 700401;

 Subject / parent(s) / legal guardian(s) understand(s) the nature of the study and is / are willing to comply with the requirements of the protocol (e.g. return for follow-up visits, completion of the Subject Diary).

Exclusion criteria: :

 Subjects who participated in precursor Study 700401 and meet ANY of the following criteria are not eligible for participation in this study:

 Subject received any TBE vaccination since his / her first booster vaccination in precursor Study 700401;

 Subject has a history of infection with or vaccination against other flaviviruses (e.g. Dengue fever, yellow fever, Japanese B encephalitis) since his / her first booster vaccination in precursor Study 700401;

 Subject is known to be HIV positive since his / her first booster vaccination in precursor Study 700401 (a special HIV test is not required for the purpose of the study);

 Subject received a blood product or immunoglobulins within 90 days before any blood draw or in the period between the blood draw and the booster vaccination (as applicable);

 Subject has a known or suspected problem with drug or alcohol abuse (> 4 liters of wine/week or equivalent level of other alcoholic beverages);

 Subject / parent(s) / legal guardian(s) is / are in a dependent relationship with the study investigator or with a study team member. Dependent relationship includes close relatives (i.e., children or grandchildren, partner / spouse, siblings) as well as employees of the investigator or the site conducting the study.

['FSME-IMMUN 0.25 mL Junior (1.2 µg TBE antigen/0.25 mL) or FSME-IMMUN 0.5 mL (2.4µg TBE antigen/0.5 mL)']


AbStats at the Bedside: Improving Patient Feeding Decisions Using an Abdominal Acoustic Score

Summary: This study is being conducted to determine whether providers who have access to their patients' acoustic intestinal rate score as calculated by an abdominal acoustic sensor that continuously monitors bowel sounds (AbStats) will be more likely to advance their patients' diets to a solid diet sooner than those who do not have access to this rate. AbStats calculates intestinal rates by using two small sensors placed on a patient's abdomen to measure and analyze their abdominal sounds.~Patients will be asked to wear a sensor every morning for 20 minutes while they are fasting daily during their inpatient visit. The sensor will measure the sounds within their abdomen. This data will be interpreted by the AbStats device, which will provide an intestinal rate measurement based on the sounds recorded by the sensors.~This intestinal rate will be provided to the patient's treating physician together with other vital signs. The doctor, at his/her discretion, may choose to use this information to make decisions about the patient's feeding status.
Inclusion criteria: inclusion criteria:

 Awake and alert

 Not on a regular diet

 No mild to moderate acute pancreatitis

 No obstructed bowel not amenable to feeding tube placement beyond the obstruction

 No massive GI hemorrhage

 No impending or established toxic megacolon

 No colonic perforation

 No severe dysmotility making enteral feeding not possible

 No high output intestinal fistula

 Able to access the gut for enteral feeding

 No abdominal compartment syndrome

 No withdrawal of care/DNAR status

 No evidence of severe or prolonged ileus

 No hemodynamic compromise (MAP <60) requiring high dose vasopressors alone or in combination with large volume fluid or blood product resuscitation to maintain cellular perfusion

 No diffuse peritonitis

 No intractable vomiting

 Not pregnant

 At least 18 years of age

Exclusion criteria: :

 Not awake and alert

 On regular diet

 Mild to moderate acute pancreatitis

 Obstructed bowel not amenable to feeding tube placement beyond the obstruction

 Massive GI hemorrhage

 Impending or established toxic megacolon

 Bowel perforation

 Severe dysmotility making enteral feeding impossible

 High output intestinal fistula

 Unable to access the gut for enteral feeding

 Abdominal compartment syndrome

 Withdrawal of care/DNAR status

 Severe ileus with NG output >1200 ml/d or gastric residual volumes >400 with additional signs of intolerance including absence of bowel sounds, abdominal distention, presence of air/fluid levels on abdominal radiographs

 Hemodynamic compromise (MAP <60) requiring high dose vasopressors alone or in combination with large volume fluid or blood product resuscitation to maintain cellular perfusion

 Diffuse peritonitis

 Intractable vomiting

 Pregnant women

 Under 18 years of age

['Fasting', 'Diet', 'Biosensing Techniques']


Comparative Efficacy and Acceptability of Antimanic Drugs in Acute Mania

Summary: Background:~Bipolar disorder is one of the most common mental illnesses affecting 1%-4% of the population, and one of the leading causes of worldwide disability. Mania is a condition of excessively elevated mood, characterizes bipolar disorder, and usually is a main cause of hospitalization. Mood stabilisers and antipsychotic drugs have long been the maintenance treatment of acute mania with and without psychotic symptoms. Though clinical trails have been demonstrated that these drugs are individually more effective than placebo in the relatively long term (e.g 4, 8 weeks). However, in the pragmatic practice, patient at acute mania urgently want to see the effectiveness, and psychiatrist under great pressure and are in great need to evaluate the very short-term effectiveness (e.g one week). If the first attempted antimanic drug fails, psychiatrist need the evidence that which medication should be to added on or switch to.~Objectives:~one main aim is to rank the short-term ( e.g.one and two week) effectiveness and acceptability of the common anti-mania drugs, including Lithium, Valproate, Oxcarbazepine, Quetiapine, Olanzapine, or Ziprasidone. Secondary aim is to investigate which medication to add on for non-responders or switch to.~Methods:~The study setting: it is expected that 120 subjects with a diagnose of DSM-IV bipolar I disorder will be recruited from Guangzhou Psychiatric Hospital, the earliest psychiatric hospital in the history of China established by Dr.J. G. Kerr in 1898.~Design:This study is a randomized, controlled trial. Participants with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of bipolar I disorder, manic or mixed episode will be randomly assigned to a treatment of Lithium, Valproate, Oxcarbazepine, Quetiapine, Olanzapine, or Ziprasidone. In the following conditions, participants will take another antimanic drug as a combination medication: 1) those who have a reduction in YMRS scores less than 25% after one week of treatment; 2) those who have a reduction in YMRS scores less than 50% after two weeks of treatment; or 3) those who have a increase in YMRS more than 30% at day 4. An antipsychotic (Quetiapine, Olanzapine, and Ziprasidone) will be added on for those who use lithium, Valproate or Oxcarbazepine as a first attempted medication; while Lithium, Valproate, or Oxcarbazepine will be added on for those who use an antipsychotic as a first attempted medication. Those participants who are recognized as non-response/partial response to two combined medications after 6 weeks of treatment will switch to Modified Electroconvulsive Therapy (MECT).~Measures: Primary outcome measures are change scores on the Young Mania Rating Scale (YMRS) and dropout rates. Secondary outcome measures include Clinical Global Impressions (CGI) Scale, Global Assessment Scale (GAS), Treatment Emergent Symptom Scale (TESS), and Brief Psychiatric Rating Scale (BPRS).~Response criteria: <25% reduction in YMRS scores or >=4 scores of CGI is defined as non-response. 25-49% reduction in YMRS scores from baseline as well as <=3 scores of Clinical General Impression (CGI) is recognized as partial response.>= 50% reduction in YMRS as well as 1 (very much improved) or 2 scores (much improved) of CGI is recognized as response. Remission is defined as a YMRS score <=12 and CGI score equal to 1 or 2.
Inclusion criteria: inclusion criteria:

 with a diagnosis of bipolar I disorder, manic or mixed phase

 equal or more than 18 scores in Young Mania Rating Scale (YMRS)

Exclusion criteria: :

 Serious general medical illness

 pregnancy and lactation

 given long-acting antipsychotic drug within the last two month

 endocrine disease( e.g.Diabetes and thyrotoxicosis)

 given thyroxine therapy within the last three months or is being given hormone therapy

 sexually active and not using contraceptives

['Lithium', 'Valproate', 'Oxcarbazepine', 'Quetiapine', 'Olanzapine', 'Ziprasidone']

Lithium Valproate Oxcarbazepine Quetiapine Olanzapine Ziprasidone


ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST)

Summary: The purpose of this study is to gain additional safety information as well as to determine after the study drug has been given to patients who have undergone total hip replacement surgery, whether the study drug is effective in preventing late deep vein thrombosis (blood clots in legs) or pulmonary embolism (blood clots in lungs).
Inclusion criteria: inclusion criteria:

 Patients scheduled for primary elective unilateral total hip arthroplasty (i.e. first time the hip is being replaced on the operative side).

 Patients who have given written informed consent to participate in this study.

Exclusion criteria: :

 Patients with a contraindication to contrast venography

 Patients with an increased risk of bleeding.

 Patients with a predefined risk for prethrombotic episodes or a history of thrombophilia.

 Other inclusion or


Subclinical Hypothyroidism and Mind in the Elderly

Summary: Some recommendations of expert consensus on subclinical hypothyroidism (SH) are controversial in those areas with not enough information to reach a conclusion, such as not recommending treatment with thyrotrophic hormone of 4-10 mUI/L and free thyroxin in normal range. The body changes or symptoms at this stage are often mistaken as aging. There are studies showing significant changes in heart (slow rate, lower ejection fraction, diastolic dysfunction); hypercholesterolemia, dysfunction cognitive abilities (memory attention…).~The prevalence of SH increases with age, reaching 14% over 65 years old. This age group increase as the population ages highlights the need for evidence to improve recommendations for the elderly.~NEUROPSI is a validated neuropsychological test sensible for mild cognitive alterations. It can be applied to individuals with little schooling.~This study aims to determine positive change in cognitive abilities (NEUROPSI), ejection fraction, and body percent of lean and adipose tissue without adverse effects, placebo versus thyroxin supplement to keep thyroid-stimulating hormone (TSH) between 0.5-2.5 mUI/L in elderly with TSH 4-10 mIU/L.
Inclusion criteria: inclusion criteria:

 TSH between 4 and 10 mUI/L inclusive

Exclusion criteria: :

 Known and treatment of thyroideal disease

 Arrythmia

 Anticoagulant treatment

 Dementia

 Disease leading to dementia (acv, LIVER....)

['levothyroxine sodium', 'excipient without levothyroxine (placebo)']


Identification of Sleep-Disordered Breathing in Children

Summary: The purpose of this research is to study and improve the methods used to detect childhood breathing problems during sleep that can affect daytime behavior at home and school. Early diagnosis of these sleep disorders may allow doctors to treat children at a time when the consequences can still be reversed.
Inclusion criteria: inclusion criteria:

 Assent of child (if over the age of 9 or younger but able to understand the nature of the study)

 At least one parent or guardian must sign an informed consent

 Child must be either a healthy volunteer or scheduled for an adenotonsillectomy for any reason

 Children scheduled for adenotonsillectomies must be referred to the program by a treating otolaryngologist who practices at the University of Michigan or St. Joseph Mercy Hospital in Ann Arbor, Michigan

Exclusion criteria: :

 Mental or physical limitations that would prevent proper interpretation of neurobehavioral tests

 Medical history that could confound interpretation of EEG or behavioral data, including epilepsy, psychiatric diagnoses (other than disruptive behavior disorders), head trauma with loss of consciousness for more than 30 seconds, or chronic medication use (e.g., benzodiazepines, other hypnotics, or antihistamines)

 Current treatment by a physician or past surgical treatment for SDB

 A known medical condition that carries independent high risk of SDB (e.g., Pierre Robin syndrome, Down syndrome, or neuromuscular disorders) or excessive daytime sleepiness (e.g., narcolepsy)

 Inability to schedule polysomnography, a Multiple Sleep Latency Test, and neurobehavioral testing before the surgical date

 Determination by any of the patient's physicians that sleep testing is required before surgery can be scheduled (to avoid the possibility that study enrollment itself could affect ability to complete the study)

 Prior enrollment of a sibling in the study

 Expectation that the child will no longer have convenient access to University of Michigan facilities within 6 months or expectation of further surgery within that period

 Additional

['Observational follow-up study of adenotonsillectomy']

['Sleep', 'Sleep Apnea Syndromes', 'Sleep Disordered Breathing']

Sleep
Sleep Apnea Syndromes
Sleep Disordered Breathing


Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia

Summary: This is a phase 2/3, randomized, open-label, active control, multi-center study to assess the safety and efficacy of solithromycin in children and adolescents with community-acquired bacterial pneumonia (CABP).
Inclusion criteria: inclusion criteria:

 History of and/or documented fever (rectal, ear, or oral temperature ≥38°C or axillary temperature ≥37.5°C) or hypothermia (rectal, ear, or oral temperature <35°C or axillary temperature <34.5°C)

 Chest radiograph infiltrates consistent with bacterial pneumonia (or pneumonia caused by atypical bacterial agents); if a subject is outpatient and starting on oral therapy, a radiograph is not required.

 Presence of at least 2 of the following signs or symptoms:

 Cough

 Difficulty breathing

 Production of purulent sputum

 Chest pain

 Grunting

 Hypotension

 Tachycardia, defined as follows:

 2 months to <24 months: ≥160 beats/min 24 months to <10 years: ≥140 beats/min

 10 years: ≥100 beats/min

 Tachypnea, defined as follows:

 2 months to <12 months: ≥50 breaths/min 12 months to <5 years: ≥40 breaths/min

 5 years: ≥20 breaths/min

 Physical exam consistent with pulmonary consolidation

 Presence of at least 1 of the following:

 Leukocytosis (≥12,000 white blood cells [WBC]/mm3)

 Leukopenia (<5000 WBC/mm3)

 ≥10% immature neutrophils (bands) regardless of total peripheral WBC

 Elevated inflammatory markers (C-reactive protein or procalcitonin)

 Oxygen saturation <97% on room air

 Organism consistent with a typical respiratory pathogen identified

Exclusion criteria: :

 Ventilator-associated or hospital-acquired pneumonia

 >48 hours of systemic antibacterial therapy

 confirmed or suspected bacterial meningitis

 breast-feeding females

 positive pregnancy test


Oxygen Therapy for the Treatment of Undifferentiated Headache in the Emergency Department

Summary: This study will randomly assign emergency department patients seeking treatment for a headache to one of three groups. The first group will receive standard emergency care as determined by the treating physician, the second group will breathe high flow air by facemask for 15 minutes, and the third group will breathe high flow oxygen by face mask for 15 minutes. The patients will be questioned in the beginning of their treatment and at 2, 5, 10, 15 and 30 minutes after it's begun about the intensity of their headache and how much relief they are experiencing from their treatment. Concentration of carbon dioxide exhaled by patients will also be recorded at 0, 2, 5, 10, 15 and 30 minutes. After fifteen minutes, the patients in groups 2 and 3 will continue with standard emergency care, which can include any treatment their physician sees fit. Patients in all three groups will receive a stopwatch in the beginning of their emergency department visit and record the total extent of time their headache will take to resolve.
Inclusion criteria: inclusion criteria:

 All patients who describe a painful sensation in the head as one of the primary reasons for their visit to the ED.

Exclusion criteria: :

 patients who need immediate oxygen after triage: Recent fire or carbon monoxide exposure_______ O2 saturation 94% or less on room air on triage vitals ______ patient arrives on supplemental oxygen_______ patient reports shortness of breath_______

 patients in whom 100% oxygen is contraindicated, potentially undesirable, or controversial: history of COPD_______ possible cardiac ischemia (mouth / jaw / neck / shoulder / chest / abdomen pain or pressure)_______ possible stroke (new focal weakness or numbness, speech, hearing or vision deficit, bowel or bladder incontinence or retention)_____

 patients unable to tolerate the gas treatment: patient not able to tolerate a face mask_______ patient requests immediate treatment with another preferred therapeutic agent_______

 treating physician or nurse request to discontinue the study at any point_______

 patients who have diminished decision-making capacity history of mental retardation or pervasive developmental disorder_______ patient not awake and alert_______ patient not oriented to self, month and year, and current location_______ patient unwilling or unable to fully participate in the research associate interview and consent process_______

 patients who are at risk for intracranial hemorrhage history of intracranial aneurythm, hemorrhage, surgery, or tumor_______ current headache began after trauma_______ current headache began after using elicit drugs_______

 patients who are at high risk for intracranial infection fever > 100.4 F on triage vitals_______ complaining of recent onset neck stiffness_______

 patients who are at high risk for extracranial head pathology ear pain or drainage_______ tooth or gum pain_______ headache localized to a skin lesion on the head______

 patient is potentially critically ill active bleeding from any source_______ heart rate <60 or >130 on triage vitals_______ systolic blood pressure <90 or >180 on triage vitals_______ respiratory rate < 10 or >30 on triage vitals_______

 patient is younger than 21_______

 patients who know or suspect they are pregnant _____


Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery

Summary: After any surgery, there is a risk of venous thromboembolism (VTE), including Deep Vein Thrombosis (DVT) in the major veins of the legs and Pulmonary Embolus (PE) in the lungs. These clots are usually prevented by the administration of low-molecular-weight heparin, a blood thinner that prevents clotting. In most surgical specialties like thoracic or vascular surgery, this treatment is used until patients are discharged from the hospital. However, in orthopaedic surgery, there is strong evidence that longer term preventative treatment up to 35 days after hospital discharge helps to reduce VTE occurrences. In thoracic surgery, there is an even greater risk of developing PE because of the surgical stress, the common presence of cancer and direct damage to blood vessels in the lung during surgery. Despite the potential utility, the use of extended VTE prevention has never been evaluated in the thoracic surgery population. If extended treatment prevents clots, more patients will avoid complications related to VTE. There is currently very limited information available on the incidence of venous thromboembolism (VTE) in patients undergoing lung cancer resection and the utility of extended thromboprophylaxis (ET) in this patient population. Furthermore, in contrast to patients undergoing orthopaedic surgery where ET has become standard of care, duration of thromboprophylaxis is not well defined in this patient population. Therefore, there is a clear need to systematically evaluate the effects of extended VTE prophylaxis on the incidence of VTE in the post-op population.
Inclusion criteria: inclusion criteria:

 Patients must be at least 18 years of age.

 Patient may be of either gender.

 Patients must be diagnosed with resectable lung cancer or metastatic lung disease eligible to complete metastasectomy.

 Patients must be undergoing one of the following surgeries: segmentectomy, wedge resection, lobectomy, bilobectomy or pneumonectomy.

 Patients must be competent to understand consent documents.

Exclusion criteria: :

 All patients with known allergic or anaphylactic reaction to contrast dye, heparin or low molecular weight heparin (LMWH).

 Patients must not be under current anticoagulation for venous thromboembolism or other medical conditions.

 Patients must not have known renal impairment (defined as estimated glomerular filtration rate of less than 30ml/min/m2 as calculated by the Cockcroft-Gault method) either pre-operatively or as identified based on blood work obtained prior to the scheduled 30-day post-operative scan.

 Patients must not have known hepatic failure, with international normalized ratio (INR) of >1.5.

 Patients with history of, or ongoing liver disease, manifested as ascites or previous peritoneal tapping for ascites.

 Patients must not be pregnant or planning to become pregnant.

 Patients must not have been diagnosed or treated for VTE in the past 3 months prior to surgery.

 Patients must not have a known, objectively confirmed bleeding disorder.

 Patients must not have a present or previous increase risk of haemorrhage.

 Patients must not have a history of previous heparin induced thrombocytopenia.

 Baseline platelet count <75,000 but transient, recovered thrombocytopenia associated with chemotherapy will not be a basis for exclusion.

 Patients must not have previously inserted inferior vena cava filter.

['Venous Thromboembolism', 'Lung Neoplasms', 'Pulmonary Embolism']

Venous Thromboembolism
Lung Neoplasms
Pulmonary Embolism


Imaging of Traumatic Brain Injury

Summary: This project aims to study the prognostic ability of various MRI imaging markers in the evaluation of TBI patients. Cognitive, social, and occupational recovery will be measured at each time point, and compared to MRI findings. Healthy volunteers will serve as a comparison to the TBI patients.~It is hypothesized that novel MRI markers of metabolism, hemodynamics, functional connectivity, and tissue microstructure will be related to the clinical status of the patient, as well as their social and occupational outcomes.
Inclusion criteria: inclusion criteria:

 Age 18 or older

 Evidence of external head injury or facial trauma, or mechanism of injury consistent with brain trauma, including loss of consciousness or altered mental status.

 Residence within 90 minutes driving time of University of Maryland Medical Center, and willingness to attend follow-up appointments.

Exclusion criteria: :

 History of white matter disease or neurodegenerative disorders including Multiple Sclerosis, Huntington's Disease, Alzheimer's Disease, or Pick's Disease.

 History of Stroke

 History of treatment or diagnosis of psychiatric conditions: Major Depressive Disorder (MDD), Bipolar Disorder (BPD), Schizophrenia, or Dementia of any type.

 History of Brain Tumor

 Status post trauma due to asphyxiation

 Preexisting contraindications for Magnetic Resonance Imaging (MRI)

 Active Duty Military Status

 Police custody or prisoner status

 Pregnant women


Breath Analysis Technique to Diagnose Pulmonary Embolism

Summary: A pulmonary embolism (PE) is a blockage in one of the arteries of the lungs, and is usually caused by a traveling blood clot. The D-dimer blood test is currently used to diagnose PEs, but it is not always accurate for individuals who have recently undergone surgery or who have inflammatory-provoking diseases. The purpose of this study is to evaluate the effectiveness of the Carboximeter, a new PE diagnostic device that measures carbon dioxide (CO2) and oxygen (O2) output, in individuals at risk for developing PEs.
Inclusion criteria: Phase I inclusion criteria:

 Experienced or is scheduled for at least one of the following:

 Hip or knee replacement surgery

 Hip or acetabular fracture surgery

 Pelvic fracture

 Decompression for spinal stenosis surgery

 Scoliosis corrective surgery

 Craniotomy surgery for brain tumor

 Surgery for any of the following cancers: bladder, colon (including caecum and rectum), kidney, ovary, pancreas, or uterus

 Phase I
Exclusion criteria: :

 Currently undergoing treatment for PE or has received treatment for PE in the 4 weeks prior to study entry

 Hospitalized for fewer than 2 days

 Anatomic abnormality that would prevent use of a mouthpiece

 Living situation that makes follow-up difficult (e.g., homeless, incarcerated)

 Phase II inclusion criteria:

 Clinical suspicion of PE with signs or symptom suggestive of PE within 24 hours of presentation and at least one risk factor for PE, as defined under the criteria as outlined in this protocol

 CTA of pulmonary arteries ordered by clinical care providers

 18 years or older or an emancipated 17 year old

 Written informed consent

 Phase II


Real-Life Evidence on Stroke Prevention in SPAF

Summary: To obtain a better understanding on the comparative effectiveness of rivaroxaban and vitamin K antagonists (VKA) for stroke prevention in patients with non-valvular atrial fibrillation (SPAF) in a real-life setting
Inclusion criteria: inclusion criteria:

 Age ≥18 years on the day of the first prescription of the study drug (= index date) during study selection window

 Diagnosis of NVAF on start date of study or anytime during 365 days before this date

 Availability of follow-up at least 180 days after the date of the first prescription of study drug within selection window of study (exposure start date)

 Evidence of patient activity in the database during 90 days before the date of the first prescription of target drug within selection window.

Exclusion criteria: :

 Patients with valvular AF

 Prescriptions of Oral Anticoagulants (OACs): VKA, Dabigatran, Rivaroxaban before index date

 Prescription of more than one OAC on the index date or switch to another OAC during the follow-up period

 Prescriptions of < 15mg rivaroxaban at index date or during the follow-up period for patients in rivaroxaban cohort

['Rivaroxaban (Xarelto, BAY59-7939)', 'Vitamin K antagonists']

Rivaroxaban (Xarelto
BAY59-7939)
Vitamin K antagonists

['Atrial Fibrillation (Prevention of Stroke)']


Zainidip in Renal Artery Stenosis

Summary: To evaluate the efficacy of renal artery stent combined with standardized medical therapy as treatment for renal artery stenosis.
Inclusion criteria: inclusion criteria:

 Age between 40 - 75

 Diameter of stenosis of renal artery or main branch of renal artery ≥60％. If diameter of stenosis is 60% - 75%, pressure difference between proximal and distal end ≥20 mm Hg (1mmHg=0.133kPa) or Captopril renography positive;

 Systolic blood pressure before taking antihypertensive ≥180mmHg and/or diastolic blood pressure ≥110 mmHg; taking three antihypertensive including one diuretics with systolic blood pressure ≥140mmHg and/or ≥90 mmHg;

 length of ipsilateral kidney is greater than 7.0cm.

Exclusion criteria: :

 Estimated glomerular filtration rate (eGFR) <30 ml/ (min﹒1.73 m 2) [eGFR (mL/min/1.73 m2) = 186.3 * serum creatinine (mg/dl) -1.154 * Age-0.203 * 0.742 (female)[11];

 unstable condition and unable to tolerate interventional therapy;

 anatomy of renal artery pathology not suitable for interventional therapy;

 allergic to dihydropyridines;

 III degree atrioventricular block

 contrast allergy ;

 any known malignant tumor;

 non-compliant, history of alcoholism or drug abuse.

['stent', 'Aspirine', 'Clopidogrel', 'Lercanidipine']

stent Aspirine Clopidogrel Lercanidipine


Effect of Normatec Pump for Relief of Leg Edema in Patients With Right Heart Failure

Summary: Mobilization of fluid from the legs with the Normatec pump in patients with right heart failure, may empty the reservoir in the legs from excessive fluid, enabling fluid overload to collect there rather than in the liver or in other third spaces. Thus, we hypothesize that patients will lose weight, feel better, look better, be less prone to infections in their legs and to congestion of the liver.
Inclusion criteria: inclusion criteria:

 Hospitalized patients

 Adults

 Right heart failure secondary to pulmonary hypertension (cor pulmonale)

 Pronounced leg edema

Exclusion criteria: :

 Patients in sepsis

 Hemodynamically unstable

 Renal failure (creatinine >2 mg%)

 Deep vein thrombosis

 Pregnancy

 Psychiatric/noncompliant patients

 Patients who will not sign the informed consent form

['Right Heart Failure', 'Cor Pulmonale']