Efficacy of Ramelteon on Insomnia Symptoms Associated With Jet Lag in Healthy Adult Volunteers

Summary: The purpose of this study to determine the degree to which ramelteon, once daily (QD), can reduce the insomnia symptoms associated with rapid, eastward travel across 5 time zones.
Inclusion criteria: inclusion criteria

 Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

 Willing to travel from Hawaii to the East Coast and have a minimum stay of 6 days at the destination in a sleep laboratory during the entire study.

 Has lived in Hawaii for at least 12 months and has not been traveling outside of Hawaii for 4 consecutive days within 30 days prior to the Outpatient Screening Visit.

 History of sleep disturbance associated with jet lag symptoms, with at least two occurrences in the last three years, as defined in the International Classification of Sleep Disorders.

 Habitual bedtime should be determined by sleep history as between 9:00 PM and 12:00 AM as determined by sleep history prior to randomization.

 Have regular bedtime (within 1 hour) for 1 week prior to travel.

 The subject has a subjective sleep latency of less than 30 minutes and a subjective total sleep time of 6.5 hours but less than 9 hours, as determined by sleep history.

 Mean subjective sleep latency of less than 30 minutes and a mean subjective total sleep time of greater than 6.5 hours but less than 9 hours in 3 of 5 nights after the outpatient screening visit, as determined by post-sleep questionnaire.

 Willingness and ability to comply with study procedures, including travel time, sleep, and waking-hour activities, light-exposure restriction, and food intake.

 Body mass index between 18 and 34, inclusive.

 Negative test result for selected substances of abuse (including alcohol) at Initial Screening, the In-Patient Actigraphy Screening Nights 1 and 2, and the Treatment Period.

 Negative test result for hepatitis B Surface antigen and hepatitis C virus antibody.

Exclusion criteria:

 Known hypersensitivity to ramelteon or related compounds, including melatonin, and melatonin related compounds.

 History of primary sleep disorders as determined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised within the past 6 months.

 Current sleep disorder as assessed by presence of sleep apnea, period leg movement syndrome, insomnia, daytime napping of more than 20 minutes, chronic fatigue.

 Ever had a history of seizures, sleep apnea, restless leg syndrome, periodic limb movement syndrome, or chronic obstructive pulmonary disease.

 History of psychiatric disorder (including schizophrenia, bipolar disorder, mental retardation, or cognitive disorder, anxiety, or depression) within the past 12 months.

 Current, clinically significant neurological (including cognitive), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease, as determined by the investigator.

 History of alcohol abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised, or regularly consumes more than 14 alcoholic drinks per week.

 History of drug abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised.

 Positive urine drug screen or a positive urine drug screen or alcohol breathalyzer test.

 Sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the administration of single blind study medication.

 Positive hepatitis panel including anti- hepatitis A virus (only IgM is exclusionary), hepatitis B surface antigen, or anti- hepatitis C virus.

 Any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.

 Any additional condition(s) that in the Investigator's opinion would:

 affect sleep/wake function

 prohibit the subject from completing the study

 cause a situation such that it would not be in the best interest of the subject to participate in the study.

 Participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the administration of study medication.

 Smokes greater than 3 cigarettes per day or uses tobacco products during nightly awakenings.

 Has flown across greater than 3 time zones within 28 days prior to or during screening.

 Reports high caffeine consumption (greater than 600 mg daily).

 Participated in any other investigational study and/or taken any investigational drug within 30 days or 5 half-lives of the investigational drug prior to the first dose of double blind study medication, whichever is longer.

 Used any central nervous system medication within 1 week (or 5 half lives of the drug, whichever is longer) prior to the administration of study medication. These medications must not have been used to treat psychiatric disorders.

 Used prescription or over-the-counter (OTC) hypnotic medication (including melatonin) within 3 months of the screening visits.

 Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:

 Anxiolytics

 Sedatives

 Antidepressants

 CNS active drugs (including herbal)

 Anticonvulsants

 Narcotic analgesics

 Sedating H1 antihistamines

 St. John's Wort

 Systemic steroids

 Kava-kava

 Respiratory stimulants

 Ginkgo-biloba

 Decongestants

 Over-the-counter and prescription stimulants

 Antipsychotics

 Over-the-counter and prescription diet aids

 Muscle Relaxants Drugs affecting sleep/wake function

 Melatonin

 Modafinil

['Ramelteon', 'Ramelteon', 'Ramelteon', 'Placebo']


Autologous Bone Marrow For Lower Extremity Ischemia Treating

Summary: The purpose of this study is to determine whether autologous bone marrow derived cells and isolated CD133+ fraction are effective in the treatment limb ischemia
Inclusion criteria: inclusion criteria:

 an obliterating lower extremity atherosclerosis IIB a stage (on Fontaine classification)

 a painless walking distance of 10-50 m

 pulse absence on аа. dorsalis pedis, tibialis posterior, poplitea

 absence of a ischemia in a rest and necrotic changes

 mainly distal form of disease (a lesion of a superficial femoral artery, a popliteal artery, anticnemion arteries) according to an angiography that testifies to impossibility of reconstructive operation performance

 patients after a lumbar sympathectomy and a tibial bone osteoperforations executed previously

 heavy smokers

Exclusion criteria: :

 insulin depended diabetes

 myocardial infarction or a stroke within last year

 an idiopathic hypertensia III stage

 anaemia and other diseases of blood

 decompensation of the chronic diseases which are contraindications to any surgical operation

 HIV infection

 a virus hepatitis

 oncologic diseases

 chemotherapy in the anamnesis

['Bone marrow aspiration, injection of cells', 'Bone marrow aspiration , injection of isolated CD 133+ cells', 'Bone marrow aspiration, injection of saline']

Bone marrow aspiration
injection of cells
Bone marrow aspiration
injection of isolated CD 133+ cells
Bone marrow aspiration
injection of saline


Evaluating the Dietary Supplement Anatabloc in Thyroid Health-ASAP (Antabloc Supplementation Autoimmune Prevention)

Summary: This is a study to evaluate the safety, tolerability, and potential effects of Anatabloc dietary supplementation on antithyroid autoantibodies, thyroid structure, and thyroid function in subjects with autoimmune thyroiditis.
Inclusion criteria: inclusion criteria:

 adults 18-70 years of age

 having positive antibodies against thyroid peroxidase

 having sonographic evidence consistent with a diagnosis of Hashimoto's thyroiditis

Exclusion criteria: :

 having evidence of end-stage thyroiditis

 being a current smoker or smokeless tobacco user

 be taking systemic glucocorticoids, interferon-alpha, anti-CD20 antibody, or anti-CTLA-4 antibody

 be taking any medication for treatment of autoimmune thyroiditis other than L-thyroxine or equivalent


Evaluation of BOTOX® With Rehabilitation Therapy for the Treatment of Wrist and Hand Spasticity in Post-Stroke Patients

Summary: The present study is designed to determine the safety and effectiveness of injections of BOTOX® in spastic muscles of the arm and hand compared with injections of saline (which would do nothing) when combined with rehabilitation therapy for the improvement of active function tasks in post-stroke patients. Injections will be targeted to reduce common spasticity patterns of the arm and hand which include: bent elbow, palm down forearm, bent wrist, thumb-in-palm, clenched fist, and other hand deformities. This will be done only at Emory University. Neither the doctor injecting the drug nor the subject receiving the drug will know if they are getting BOTOX® or saline. Which type of injection the subject receives will be completely randomized (like flipping a coin). All subjects will have rehabilitation therapy after their injections. Subjects will be assessed at a total of 5 scheduled visits (qualification (Week 1), Injection (Week 2), Evaluations on Weeks 8, 10, and 14. All subjects will receive rehabilitation therapy immediately after their injections for 1 hour a day, 3-5 times a week, for 4 weeks. The results from this project will provide valuable data on the ability of BOTOX® and physical rehabilitation to provide effective treatment to spastic muscles of the arm and hand after stroke. This project has the potential to increase the availability of effective rehabilitation techniques to patients with stroke.
Inclusion criteria: inclusion criteria:

 Male or female, 18 to 70 years of age

 Written informed consent

 Written Authorization for Use and Release of Health and Research Study Information has been obtained

 Medically stable condition in the investigator's opinion

 History of stroke (hemorrhagic or ischemic) that resulted in a unilateral, upper-limb focal spasticity pattern of the wrist and fingers

 EMG evidence of volitionary activiation of wrist and finger extensor and flexor muscles

 Active range of motion (to be repeated 3 times by the patient): The ability to initiate wrist extension of at least 10 degrees from a fully flexed position with the forearm supported and stabilized in a pronated position. Active shoulder flexion and abduction to 45 degrees and no less than -30 degrees of elbow extension.

 Mini-Mental State Exam (MMSE) >24

 If on an anti-spasticity medication regiment at the time of qualification, the dose regimen must have been stable 1 month prior to study enrollment

 Ability to follow study instructions and likely to complete all required visits

Exclusion criteria: :

 Time since neurological event resulting in upper limb spasticity less than 3 months or greater than 24 months

 Previous therapy with BOTOX® or any other botulinum toxin serotype for any condition within the last 12 months

 Phenol or alcohol block in the study limb within 6 months of study enrollment visit

 History (within 3 months of qualification) of or planned (during study period) casting of the study limb

 Current treatment with an intrathecal baclofen pump

 In the opinion of the investigator, profound atrophy of the muscles in the study limb that are targeted for injection

 Previous surgical intervention in the study limb, except for routine orthopedic repair for bone fractures, in the last 6 months

 Presence of fixed contracture of the study limb impairing functional activity

 Clinically significant inflammation or condition in the study limb that, in the investigator's opinion, could limit joint movement (other than stroke or spasticity)

 Clinically significant spasticity or contracture of the elbow (defined as an Ashworth score >3) or shoulder in the study limb, in the investigator's opinion would limit sue of the wrist and fingers

 Changes in oral spasticity medications within 30 days of enrollment (dose of anti-spasticity medications should remain the same during the study)

 Anticipated use of oral coagulants during the study

 Known allergy or sensitivity to the study medication or its components

 Infection or dermatological condition at anticipated injection sites

 Current participation in another clinical study or within 1 month of the enrollment visit

 Females who are pregnant, nursing, or planning a pregnancy during the study, or females of childbearing potential, not using a reliable means of contraception

 Anticipated use during the study of concurrent therapies for treatment of upper motor neuron syndrome (eg, acupuncture)

 Any medical condition that may put the patient at increased risk with exposure to BOTOX including diagnosed myasthenia gravis, Eaton-Lambert Syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function

 Patient has a condition or is in a situation which in investigator's opinion may put the patient significant risk, may confound the study results, or may interfere significantly with patient's participation in the study

['Botox and rehab', 'Placebo and rehab']


Efficacy of Letrozole and CC Alone in an IUI Program in Cases With Surgically Treated Minimal to Mild Endometriosis

Summary: To evaluate pregnancy rates with letrozole and CC alone in an IUI program for women with recently surgically treated minimal to mild endometriosis.
Inclusion criteria: inclusion criteria:

 Patient with minimal-mild endometriosis recently treated by laparoscopy with a waiting period of 6 to 12 months following the procedure

 No other infertility factors.

 Normal serum basal hormone levels as well as documented ovulation

Exclusion criteria: :

 Moderate or severe endometriosis

 Dense adnexal and/or ovarian adhesions due to pelvic inflammatory disease or previous pelvic surgery

 Age more than 36 years, BMI more than 30 kg/m2

 women with a previous pregnancy


A Trial for Patients With Gestational Trophoblastic Disease

Summary: This phase II study is evaluating the activity of Pemetrexed in patients diagnosed with low risk Gestational Trophoblastic Tumor (GTT) that have failed prior treatment.
Inclusion criteria: inclusion criteria:

 Persistent or recurrent low risk Gestational Trophoblastic Tumor (GTT)

 WHO score 2-6 (re-evaluated at the time of relapse

 Histologically confirmed complete or partial moles on initial evacuation

 Patients with mild to moderate renal insufficiency should avoid taking NSAIDs with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of pemetrexed.

 All patients taking NSAIDs with longer half-lives, should interrupt dosing for at least 5 days before, the day of, and 2 days following pemetrexed administration.

 Folic Acid (350-1000 micrograms) must be given daily beginning approximately 5-7 days prior to first dose of pemetrexed and continuing daily until 3 weeks after the last dose of study therapy.

 Vitamin B12 (1000 micrograms) will be administered as an intramuscular injection approximately 1 to 2 weeks prior to first dose of pemetrexed and repeated approximately every 9 weeks until 3 weeks after the last dose of study therapy.

Exclusion criteria: :

 Previous treatment that included chemotherapy other than actinomycin -D or methotrexate (+/- folinic acid).

 Patients with more than 8 metastatic lesions identified

 Patients with metastases to liver, spleen, brain, kidney or GI tract

['Trophoblastic Neoplasms', 'Uterine Neoplasms', 'Hydatidiform Mole', 'Choriocarcinoma']

Trophoblastic Neoplasms
Uterine Neoplasms
Hydatidiform Mole
Choriocarcinoma


Smoking Status and Body Image in Oral Cancer Patients

Summary: Primary Objectives:~To characterize smoking behaviors and body image in patients with oral cavity cancer prior to and following surgical procedures.~To examine the relationship between smoking status and body image in this sample of head and neck cancer patients.~To examine the influence of smoking status and body image on quality of life outcomes.
Inclusion criteria: inclusion criteria:

 18 years of age or older

 Able to provide written informed consent to participate

 Diagnosis of head and neck malignancy involving an oral cavity site without previous treatment

 Current treatment plan includes surgical intervention

 English speaking

Exclusion criteria: :

 Previous treatment for malignancy in the head and neck region

 Significant preexisting facial disfigurement from a previous trauma or congenital defect

 Diagnosis of a serious mental illness involving formal thought disorder (e.g., Schizophrenia) documented in medical record.


Post-Embolic Rhythm Detection With Implantable Versus External Monitoring

Summary: The overall aim of this trial is to determine the most cost effective approach to diagnose paroxysmal atrial fibrillation (PAF) following transient ischemic attack (TIA) and stroke.~A summary of the rationale for this study is as follows:~Recently completed randomized trials of cardiac monitoring following stroke have established that PAF is more common than previously recognized in cryptogenic stroke.~The majority of TIA/stroke patients will have at least one potential stroke mechanism identified by the time etiologic investigations completed.~Detecting PAF in patients with strokes with known causes (eg. lacunar and large vessel atherosclerosis) is clinically important since appropriate anticoagulation for AF reduces stroke recurrence in all patients with prior TIA/stroke not just cryptogenic strokes.~There are competing technologies for evaluating cardiac rhythm and diagnosing AF but no cost effectiveness data~The rates of PAF in strokes with known causes (SKC) have not been well characterized.~PER-DIEM is a pilot study to compare two different cardiac monitoring technologies as first-line investigations to detect PAF in patients with recent stroke and TIA. The study will also assess whether a pivotal trial is feasible and warranted.~The principal research questions to be addressed in this study will be:~Whether implantable loop recorder (ILR) plus remote monitoring will diagnose more paroxysmal AF / atrial flutter and provide a better assessment of the total burden of AF resulting in a greater proportion of patients started on an OAC versus the external loop recorder (ELR) strategy.~What is the relative cost-effectiveness as a first-line investigation of long-term implantable ECG (ILR) coupled with remote monitoring for 12 months compared to external event-triggered ECG loop recorder (ELR) for 30 days in the diagnosis clinically actionable AF in following TIA/stroke.~2) What is the feasibility, patient compliance, diagnostic accuracy and rates of AF detection (>30 seconds) of ILR compared to the ELR strategies.
Inclusion criteria: inclusion criteria:

 Diagnosis of the index event* made by a stroke specialist of an acute ischemic stroke or TIA occurring within the previous 90 days. The event must be either:

 an arterial ischemic stroke confirmed by neuroimaging; or

 transient ischemic attack with diffusion weighted positive lesion on MRI

 At least one 12-lead ECG has already been obtained as part of the routine clinical post-stroke/TIA work-up, and no ECGs have shown any episodes of atrial fibrillation or atrial flutter

 The patient is being actively investigated for the etiology of the stroke/TIA event and additional cardiac monitoring is desired to screen further for the possibility of occult paroxysmal atrial fibrillation/flutter

 Age 18 years or older

 Informed consent from the patient

 The patient is expected to survive at least 6 months.

Exclusion criteria: :

 Any previously documented atrial fibrillation or atrial flutter, i.e. a past history of atrial fibrillation/flutter or atrial fibrillation/flutter detected on ECG, Holter, or telemetry following the index stroke/TIA event (a remote history of transient perioperative atrial fibrillation is not exclusionary)

 Planned carotid endarterectomy or carotid artery stenting within 90 days

 Any condition for which there is already an indication for long term anticoagulation Pacemaker or implantable cardioverter defibrillator device

 Work-up for stroke that has already included extended (>48 hour) external ECG (excluding telemetry)

 Stroke and/or comorbid illness will prevent completion of planned follow-up assessments

['Medtronic Reveal LINQ', 'Sorin Spiderflash-t']

Medtronic Reveal LINQ
Sorin Spiderflash-t

['Stroke', 'Atrial Fibrillation', 'Arrhythmias, Cardiac']

Stroke
Atrial Fibrillation
Arrhythmias
Cardiac


Ultrathin Bronchoscopy for Solitary Pulmonary Nodules

Summary: The evaluation of solitary pulmonary nodules (SPN) requires a balance between procedure-related morbidity and diagnostic yield, particularly in areas where tuberculosis is endemic. Data on ultrathin bronchoscopy (UB) for this purpose is limited. In this prospective randomised trial we compared diagnostic yield and adverse events of UB with standard-size bronchoscopy (SB) in a cohort of patients with SPN located beyond the visible range of SB.
Inclusion criteria: inclusion criteria:

 Pulmonary nodule on a recent CT

 non-visible on standard-size bronchoscopy

Exclusion criteria: :

 missing informed consent


Bioavailability Study Comparing 10 mg Amlodipine Besylate Orally Disintegrating Tablets (ODT) And 10 mg Amlodipine Besylate Capsules

Summary: This study is being performed to determine the bioavailability, or extent of absorption into the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to the bioavailability of a 10 mg amlodipine besylate capsule.
Inclusion criteria: inclusion criteria:

 Healthy male and/or female literate subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

 Body Mass Index (BMI) of 17.5 to 26.4 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion criteria: :

 Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

 A positive urine drug screen.

['Amlodipine - reference', 'Amlodipine ODT - test']

Amlodipine - reference
Amlodipine ODT - test


Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Me-chanical Ventilation - Effects on Cognitive Function

Summary: Through many years, the standard care has been to use continuous sedation of critically ill patients during mechanical ventilation. However, preliminary randomised clinical trials indicate that it is beneficial to reduce the sedation level in these patients. The NONSEDA trial is an investigator-initiated, randomised, clinical, parallel-group, multinational, superiority trial designed to include 700 patients from at least six ICUs in Denmark, Norway and Sweden, comparing no sedation with sedation and a daily wake-up trial during mechanical ventilation. This is a substudy of the NONSEDA trial, concerning 250 patients included at trialsite Kolding, Denmark. The aim of the substudy is to assess the effects of no sedation on delirium during admission and cognitive function after discharge from ICU.~Our hypothesis is that critically ill patients who are not sedated during mechanical ventilation will have better cognitive function after discharge.
Inclusion criteria: inclusion criteria:

 Endotracheally intubated

 Expected time on ventilator > 24 hours

 Age ≥ 18 years

 Informed consent

Exclusion criteria: :

 Severe head trauma where therapeutic coma is indicated

 Therapeutic hypothermia where therapeutic coma is indicated

 Status epilepticus where therapeutic coma is indicated

 Patient has participated in the study before

 Patient is transferred from another ICU with length of stay > 48 hours

 Patient is comatose at admission

 PaO2/FiO2 ≤ 9, if sedation is necessary for oxygenation

 Patient does not speak Danish, swedish or norwegian at a reasonable level


Open-Label and Single-Arm Study of MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adults

Summary: Multicenter, open-label, outpatient study of the safety and effectiveness of repeated doses of MYOBLOC over a 1-year duration in adult subjects with troublesome sialorrhea.
Inclusion criteria: inclusion criteria:

 Seeking treatment for troublesome sialorrhea for at least 3 months that is occurring secondary to any disorder or related to any cause, including, but not limited to, Parkinson's Disease (PD), adult cerebral palsy, amyotrophic lateral sclerosis (ALS), stroke, traumatic brain injury, oral cancer, and side effects of other medications.

 Able to read and provide written informed consent before enrollment into the study, or the subject's caregiver (Legally Authorized Representative) can provide written informed consent.

 Male or female, 18 to 85 years of age (inclusive).

 Minimum unstimulated salivary flow rate of 0.2 g/min at screening

 Minimum Investigator's Drooling Frequency and Severity Scale (DFSS) score of 4 at screening.

 Ability and availability to participate in the study for up to 1 year (ALS subjects: ability and availability to participate in the study for at least 6 months), based on overall health of the subject and disease prognosis

Exclusion criteria: :

 A moderate to high risk of aspiration will exclude participation in this study. Subjects whose risk of aspiration are judged by the Investigator to be satisfactorily controlled by placement of PEG tube or G-tube for nutritional support are eligible to participate.

 Respiratory forced vital capacity (FVC) of <20% of predicted

 Prior botulinum toxin type A or B treatment in the salivary gland(s) identified for treatment in this study within 24 weeks before screening. Prior botulinum toxin type A or B treatment into other anatomical regions not selected for treatment in this study is not exclusionary, but must have occurred at least 12 weeks before screening

 Subjects should be excluded if, in the Investigator's opinion, the subject failed to respond to previous treatment with botulinum toxin. Subjects should not receive nor have any plans for receiving any botulinum toxin treatment, other than the study drug (MYOBLOC), during the entire course of the study (from the point the informed consent is signed until subject's participation is complete).

 Concomitant use, or exposure within 5 half-lives of screening, of aminoglycoside antibiotics, curare-like agents, or other agents that interfere with neuromuscular function

 Prior salivary gland surgery

 Current treatment or treatment at any time during the study with Coumadin® (warfarin) or similar anti-coagulant medications. Anti-platelet medications are not specifically exclusionary

 Evidence of any clinically significant neurologic disease

 Pregnancy or lactation

 Anticipated or scheduled surgery during the study period. A PEG tube/G tube may be placed for nutritional support at any time during the study and will not exclude the subject from continued study participation.

 Major surgery (requiring general anesthesia, except PEG tube/G tube placement ) within the previous 6 months before screening.

 Current infection at the sialorrhea treatment injection site(s)

 History of drug or alcohol abuse currently or within the previous 6 months

 Participation in another clinical drug, device, or biological agent study within 30 days of screening or while participating in this study


Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus

Summary: Type 2 diabetes mellitus is usually associated with high blood pressure, which is a risk factor for kidney disease. Aggressive blood pressure reduction is an important strategy to protect the kidney and reduce urinary protein which develops with kidney disease. This study will evaluate the effects of amlodipine/benazepril in reducing blood pressure and urinary protein in hypertensive subjects with type 2 diabetes mellitus.
Inclusion criteria: inclusion criteria:

 Mild to moderate hypertension

 Type 2 diabetes mellitus

 Presence of protein in the urine (albuminuria)

Exclusion criteria: :

 Kidney disease not caused by diabetes or hypertension

 Renal artery stenosis

 Myocardial infarction or stroke within the last 6 months

 Type 1 diabetes mellitus

 Pregnant or lactating females

 Cancer within the last 5 years


Alterations of Blood Clotting With the Use of Sequential Compression Devices on the Lower Limbs

Summary: This study aims to assess possible alteration in coagulation (blood clotting) following treatment with sequential compression devices (SCD) plus low-molecular weight heparin (LMWH) as opposed to LMWH alone.~The investigators will examine coagulation in the early postoperative period of patients undergoing major abdominal surgery during their stay in our Intensive Care Unit.~In addition to common laboratory tests, the investigators will examine coagulation using TEG®, a device which allows a semi-quantitative examination of all phases of coagulation.
Inclusion criteria: inclusion criteria:

 Elective major abdominal surgery for neoplasm

 Planned admission to postsurgical ICU due to the patient's meeting one or more of the following:

 ASA Physical Status Class 4

 Surgery of modified Johns-Hopkins class ≥IV

 ASA 3 with modified Johns-Hopkins class 3 surgery

 Expected duration of surgery ≥8 h

Exclusion criteria: :

 History of coagulation abnormalities, either congenital or acquired

 Ongoing treatment with anticoagulants/antiplatelet agents other than LMWH or hormones

 Massive edema of the legs

 Severe peripheral arteriopathy or neuropathy

 Malformations or recent surgery/trauma to the lower extremities

['Sequential compression device therapy', 'Dalteparin', 'TEG']

Sequential compression device therapy
Dalteparin
TEG

['Coagulation, Blood', 'Compression Devices, Intermittent Pneumatic', 'Postoperative Complications', 'Thrombelastography']

Coagulation
Blood
Compression Devices
Intermittent Pneumatic
Postoperative Complications
Thrombelastography


Lupus Nephritis: Role of Environmental and Occupational Exposures

Summary: The purpose of this study is to examine hormonal and environmental risk factors (and possible gene-environmental interactions) involved in the etiology of lupus nephritis. Our study will focus on exposures to occupational and environmental agents that have been linked to the development of systemic lupus erythematosus (SLE) or renal disease (e.g., silica dust, smoking). We will also assess potential gene environment interactions. We will examine these exposures in 100 patients with renal biopsy with documented proliferative or membraneous nephritis. We will compare exposures in the lupus nephritis patients to lupus patients who do not have nephritis and to normal controls who have participated in the Carolina Lupus Study. One hundred lupus nephritis patients (age 18 years or older, of both genders and all races) will be identified through the Glomerular Disease Collaborative Network (GDCN) Nephropathology database and participating nephrologists at the Medical University of South Carolina, Duke University Medical Center and the East Carolina Medical School.
Inclusion criteria: inclusion criteria:

 Have renal biopsy proven Lupus Nephritis (with the biopsy-based diagnosis date no earlier than January 1, 1995).

 Reside within designated counties of eastern North Carolina and South Carolina.
Exclusion criteria:


The Alteration of Macrophage Function in the Spleen Tissues From Patients With Primary Immune Thrombocytopenia

Summary: This project was undertaken by Qilu Hospital of Shandong University and other well-known hospitals in China. In order to report the alteration on the macrophage function in the spleen tissue of primary immune thrombocytopenia (ITP).
Inclusion criteria: inclusion criteria:

 adult ITP patients whose platelet counts remain less than 10 x 10^9/L

 patients whose platelet counts remain less than 30 x 10^9/L and who continue to experience excessive bleeding after 4 to 6 weeks of appropriate medical treatment

 patients who have experienced a transient response to primary treatment and have platelet counts less than 30 x 10^9/L after 3 months

 require continuous glucocorticoid therapy to maintain safe platelet counts

 Willing and able to sign written informed consent.

Exclusion criteria: :

 Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.

 Current HIV infection or hepatitis B virus or hepatitis C virus infections.

 Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)

 Female patients who are pregnant.

 Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.

 Patients who are deemed unsuitable for the study by the investigator.


Low-dose CT for Diagnosis of Pneumonia in COPD Exacerbations and Comparison of the Inflammatory Profile.

Summary: * Hypothesis: There is an underdiagnosis of pneumonia in COPD (Chronic Obstructive Pulmonary Disease) exacerbations which could be demonstrated by performing low-dose chest CT. Differences in the inflammatory profile in sputum and blood in patients with and without pneumonia can be seen.~* Objective: To assess the degree of underdiagnosis of pneumonia in COPD exacerbations, using chest low-dose CT and to compare clinical and inflammatory differences in blood and sputum between patients with and without pneumonia.~*Material and Methods: Prospective observational study including 75 patients with the diagnosis of COPD at the time of an exacerbation and with criteria for a respiratory tract infection. At the time of inclusion clinical features, blood and sputum analysis, chest X-ray and chest low-dose CT are performed. The investigators divide the patients into two groups according to the existence of pneumonia and the inflammatory pattern in blood (inflammatory markers) and sputum (cell populations and inflammatory markers) is compared between the two branches.
Inclusion criteria: inclusion criteria

 clinical and spirometric diagnosis of COPD.

 for study group: clinical symptoms of exacerbation and infection of low airway.

 Signed informed consent.

Exclusion criteria:

 No acceptance of informed consent.

 The STUDY GROUP: treatment with antibiotic more tan 2 days before consultation.

 Another entity known pulmonology other than COPD (non-obstructive disorders, bronchiectasis, interstitial lung disease patients, severe pulmonary hypertension, hypoventilation).

 Chronic treatment with oral corticosteroids or immunosuppressive drug.

 severe organ comorbidity such as cancer in advanced or terminal phase, pulmonary tuberculosis with important involvement, severe pneumoconiosis.

 Severe alteration of nutritional status.

 Heart disease evolved.

 Limitation for understanding the study (including psychiatric disorder, language problem, social or cultural differences, etc.).


Effects of Botulinum Toxin Injections in Patients With Hereditary Spastic Paraplegia

Summary: Hereditary spastic paraplegias constitute a heterogeneous group of diseases with the common predominant feature of spasticity of the lower limbs. The clinical picture is composed of difficulty walking, exaggerated deep reflexes, pathological reflexes such as the Babinski sign, sphincter disturbances and various degrees of weakness as well as sensory disturbances.~Spasticity is the symptom that provoques greater incapacity. Although there have been recent advances in the genetic and pathogenic characterization of SPG there is scarcity of therapeutic options. The Botulinum Toxin (BTx) is a well established treatment for movement disorders such as cervical dystonia, blepharospasm, and arm spastic following stroke.~Therefore, the investigators propose the execution of a randomized, double-blind, placebo-controlled, crossover study to evaluate the efficacy of the treatment with Btx over SPG patient's gait. The primary outcome measure will be gait velocity with the 10 meter walking test 8 weeks after injection. Each participant will be submitted to one injection session of Btx and one of placebo (consisting of sterile sodium chloride), each one separated by a period of 6 months. The primary and secondary outcomes will be evaluated by a blind investigator 8 weeks after each injection session.
Inclusion criteria: inclusion criteria:

 Age between 18 and 80 years

 Clinical diagnosis of Hereditary Spastic Paraplegia

 Ability to walk at least 10 meters: Assistive devices are permitted

Exclusion criteria: :

 Wheelchair bound patients

 Additional neurological symptoms that may significantly impact gait such as ataxia, polyneuropathy or dementia.

 Fixed tendon contractures

 Antecedents of allergy or adverse reaction to botulinum toxin

 Pregnancy or breastfeeding condition

 Mental retardation

 Dementia

['Botulinum Toxin Injections', 'Placebo Injections']

Botulinum Toxin Injections
Placebo Injections


Potential Risk Factors for Stroke

Summary: Early studies have shown that the immune system may play a role in the development of strokes. Conditions such as high blood pressure, high cholesterol, diabetes, and old age can activate the immune system and increase the risk of developing hardening of the arteries (atherosclerosis) and damaged blood vessels.~Researchers will attempt to characterize factors that may contribute to atherosclerosis and stroke by measuring certain components of the immune system, cytokines and leukocyte activation. Measurements will be taken from patients that are considered to be stroke prone and from patients without risk factors for the development of stroke. Researchers will measure the immune system components at the beginning of the study, at six months, and at the one-year completion of the study.~The study will attempt to determine;~I) If patients with risk factors for stroke have an increased activation of the immune system~II) If patients with risk factors for stroke that are symptomatic have higher levels of immune system activation compared to patients who do not have symptoms~III) If patients with increased activation of the immune system have accelerated hardening of the arteries (atherosclerosis)
Inclusion criteria: Male or female greater than 18 years of age.

 Patient must have documented hypertension (diastolic BP greater than 90 mmHg or systolic BP greater than 140 mmHg) for greater than 1 year OR hypercholesterolemia (LDL greater than 160 or total Chol greater than 240 with a total cholesterol/HDL-Chol ratio more than 1.6 for greater that 1 year OR Diabetes (blood glucose greater than 150 mg/dl requiring oral antihyperglycemics or insulin dependent) for greater than 1 year OR any combination.

 Subgroup eligibility for risk factors with cerebral ischemic events must meet criteria #2 plus documented stroke by physical exam and CT and/or MRI consistent with ischemic infarction or TIA witnessed and recorded by medical personnel.

 Patient will be excluded if enrollment time is within 30 days of a stroke, myocardial infarction, or surgery. Patient may be enrolled after 30 days of the above events.

 No patients on immunosuppressive therapy.

 No patients who are unable to follow up for 1 year from the time of enrollment.

 No stroke patients with an identifiable cardiac source (including atrial fibrillation, mural thrombus, valvular disease with vegetation).
Exclusion criteria:

['cytokine and leukocyte activation profile']

['Carotid Atherosclerosis', 'Cerebrovascular Accident', 'Diabetes Mellitus', 'Hypercholesterolemia', 'Hypertension']

Carotid Atherosclerosis
Cerebrovascular Accident
Diabetes Mellitus
Hypercholesterolemia
Hypertension


Stroke DOC Arizona TIME - Stroke Team Remote Evaluation Using a Digital Observation Camera

Summary: Noninvasive prospective multi-center study of an interactive 2-way, wireless or site-independent, audiovisual telemedicine system designed for real-time remote examination of acute stroke symptoms and deficits as a basis for treatment consultation and recommendation.~Study aims (1) to determine the impact of a site-independent, remote, telemedicine consultation system on decision making in the Emergency Department, regarding the decision to treat or not to treat with thrombolytics; (2) to assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine versus telephone only; (3) to assess the appropriateness of thrombolytic treatment decisions in telemedicine versus telephone-only consultations; and (4) to assess the completeness of the data collection in telemedicine versus telephone-only consultations.~60 patients in Arizona with acute presentation of stroke symptoms, per bedside practitioner discretion (onset generally less than 12 hours and likely less than 3 hours)~Two arms: Video Camera/Telemedicine (Intervention n = 30) and No Video Camera/Telephone only (Control n = 30)
Inclusion criteria: Subject inclusion criteria

 For inclusion in the study, subjects must fulfill all of the following criteria:

 Written Informed Consent

 Eighteen years of age or older

 Symptoms consistent with acute stroke (ischemic or hemorrhagic)

 Acute presentation of stroke symptoms, per bedside physician discretion (onset generally less than 12 hours and likely less than 3 hours)

 Subject
Exclusion criteria:

 The following is the sole criterion for exclusion from the study:

 Unlikely to complete study through 90-day follow-up

['Telephone', 'Two way audio/video telemedicine consult']


Observational Registry of Acthar Gel for Participants With Multiple Sclerosis Relapse

Summary: Acthar Gel was first approved by the Food and Drug Administration in 1952.~It has been used to treat many different illnesses, including multiple sclerosis.~This study will observe how treatment with Acthar affected the daily lives of patients who suffer with relapsing/remitting MS.~It will collect information on symptoms, recovery, treatment patterns and safety outcomes.
Inclusion criteria: inclusion criteria:

 Male or Female ≥ 18 years of age.

 Patient has a clinically definite relapsing form of Multiple Sclerosis according to McDonald Criteria (2010 revision).

 Patient with an acute MS exacerbation as determined by their treating clinician.

 Patient planning to initiate Acthar Gel for the treatment of an acute MS exacerbation.

 Patient capable of providing informed consent.

Exclusion criteria: :

 Patients with a diagnosis of Progressive MS.

 Patients that require concomitant corticosteroid therapy.

 Patients receiving experimental drug therapy.

 Patients with a history of scleroderma, systemic fungal infections, ocular herpes simplex within prior 5 years.

 Patient has any solid tumor malignancy currently diagnosed or undergoing therapy, or has received therapy for any solid tumor malignancy in the 5 years prior to the Enrollment Visit, with the exception of treated and cured basal cell carcinoma, treated and cured squamous cell carcinoma of the skin, and treated and cured carcinoma in situ of the cervix.

 Patients who had recent surgery or have a history of or the presence of a peptic ulcer within 6 months prior to study entry, congestive heart failure, or sensitivity to proteins of porcine origin.

 If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use appropriate birth control.


Microbiome Changes in Travelers to Tropical Destinations

Summary: The human gut contain a wide range of microorganisms creating the gut microbiome. The microbiome has great impact on metabolic and immunologic processes and responses. Travelers who travel to tropical destinations where the intestinal infection risk is high are prone to microbiome changes. During the current study the travelers will give feces specimen before and after the travel and their microbiome will be analyzed.
Inclusion criteria: inclusion criteria:

 Travelers who intended to travel to tropical areas

 Good general health

Exclusion criteria: :

 Medication consumption

 Background diseases


Immunogenicity and Safety of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Infants and Children

Summary: Haemophilus influenzae is an important pathogen which can cause primary infection and respiratory viral infection in infants and leaded to secondary infections. The infection of haemophilus is a major cause of morbidity and mortality in infants and children. At present, the developed conjugant Hib vaccine is proved to be safe and effective. Because Hib vaccine can prevent meningitis, pneumonia, epiglottis inflammation and other serious infection caused by Hib bacteria, the WHO suggested that Hib vaccine should be included in the infant's normal immune programming.~Since the use of meningitis aureus polysaccharide vaccine, incidence of a disease in recent years is declined and maintain to the level of 0.5 per 1/100 thousand. But meningitis aureus polysaccharide vaccine with a relatively poor immune response in the infants under the age of two, and the remaining 60% with a low antibody level and a short duration.~According to the present immunization schedule, to reach the median level of antibody levels there are at least 4 doses in need. So it is meaningful to improving vaccine immunogenicity, to provide high levels of long-term protection and to reduce the number of injections.~After the phase I study which was conducted in August, 2011, the safety profile of this vaccine is proved to be acceptable. The phase III study is aimed to further evaluate the safety and the immunization of the vaccine. The objective of this study is to evaluate the safety of the group A, C polysaccharide meningococcal and type b haemophilus influenzal conjugate vaccine.
Inclusion criteria: For the children (aged from 2 to 5 years old)

 inclusion criteria:

 Healthy subjects aged from 2 to 5 years old of normal intelligence.

 The subjects' guardians are able to understand and sign the informed consent.

 Subjects established as healthy after medical history questioning, physical examination and clinical decision and in accordance with vaccination requirements of the investigational vaccine.

 Subjects who can comply with the requirements of the clinical trial program according to the researcher's views.

 Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine.

 Subjects with temperature <37°C on axillary setting.

Exclusion criteria: :

 Subject who has a medical history of Meningitis;

 Subject that has a medical history of any of the following: allergies, seizures, epilepsy, encephalopathy history and so on;

 Subject who is allergic with tetanus toxoid components;

 Subject suffering from thrombocytopenia or other coagulation disorder may lead to contraindication to intramuscular injection;

 Subject who has a history of allergic reactions;

 Any known immunological dysfunction;

 Had received gamma globulin or immune globulin, in the past two weeks

 Subject suffering from congenital malformations, dysgenopathy or serious chronic disease;

 Any acute infections

 Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives

 For the infants (aged from 6 to 23 months old)

 inclusion criteria:

 Healthy subjects aged from 6 months to 23 months old of normal intelligence.

 The subjects' guardians are able to understand and sign the informed consent.

 Subjects established as healthy after medical history questioning, physical examination and clinical decision and in accordance with vaccination requirements of the investigational vaccine.

 Subjects who can comply with the requirements of the clinical trial program according to the researcher's views.

 Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine.

 Subjects with temperature<37°C on axillary setting.

['A+C+hib Conjugate Vaccine', 'Placebo', 'A+C Vaccine', 'Hib vaccine']

A+C+hib Conjugate Vaccine
Placebo
A+C Vaccine
Hib vaccine

['Group A, C Polysaccharide Meningitis', 'Type b Haemophilus Influenza']

Group A
C Polysaccharide Meningitis
Type b Haemophilus Influenza


Healthy Body Study

Summary: Few obesity prevention programs have produced weight gain prevention effects that persist over long-term follow-up and those that have are extremely lengthy, averaging 52 hr in duration, making implementation difficult and costly. The 2010 US Preventative Services Task Force (USPSTF) recommendations for treating child & adolescent obesity state that programs should have ≥ 25 hr of comprehensive treatment including dietary, physical activity and behavioral counseling, and that programs with < 25 hr usually do not produce improvements. The implication is that, if centers cannot provide this level of service (as most cannot), it is not worth providing any kind of treatment at all. In extreme exception to this, an intensive 3-hr non-restrictive obesity prevention program involving participant-driven healthy lifestyle improvement plans designed to bring caloric intake and output into balance (Healthy Weight) has been found to significantly reduce increases in BMI and obesity onset relative to alternative interventions and assessment-only controls through 3-yr follow-up. We propose to test an extended 6-hr version of the Healthy Weight intervention in a sample of primarily low SES, minority adolescents and young adults who are overweight and report body dissatisfaction and subthreshold eating disorder symptoms, as these are prevalent risk factors for obesity. We will test the hypothesis that participants assigned to the Healthy Weight vs. control intervention will have significantly lower BMI and % body fat during follow-up. Secondary outcomes will include body dissatisfaction, depressive symptoms, and eating disorder symptoms. 300 adolescents and young adults at high risk for future weight gain by virtue of their age, BMI percentile, body dissatisfaction and eating disorder symptomatology will be randomized to Healthy Weight or weight control educational video. Participants will complete assessments of BMI, body composition, potential mediators, and other outcomes at pretest, posttest and 6--mo follow-ups (in yr 1). Thus, to refute the USPSTF recommendations statement, we propose to show that a 6-hr intervention led by graduate students can produce significant reductions in risk for both obesity and eating disorders, suggesting this inexpensive and brief intervention could and should be rolled out nationwide.~Primary Aim: To test the hypothesis that Healthy Weight will significantly reduce increases in BMI, % body fat, and risk for onset of obesity during follow-up.~Secondary Aim: To test the hypothesis that Healthy Weight will significantly reduce body dissatisfaction, depressive symptoms, and eating disorder symptoms.~NOTE: THIS STUDY IS ONLY OPEN TO PATIENTS AT THE MOUNT SINAI ADOLESCENT HEALTH CENTER
Inclusion criteria: inclusion criteria:

 ≥ 12 years old

 Body image concerns

 Sub-threshold Eating disorder symptomatology

 Overweight but not obese (BMI between the 85th and 95th percentile for children/adolescents and BMI between 25 and 30 kg/m2 for adults 21-24)

 Be able to commit to weekly 1-hour sessions for six weeks and 3 separate assessment visits to the MSAHC

Exclusion criteria: :

 Current eating disorder (anorexia nervosa, bulimia nervosa or binge eating disorder)

 absence of body image concerns

 normal or obese body weight (< 85th or ≥ 95th BMI percentile)

['Healthy Weight', 'Controlled Intervention']


Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis

Summary: Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe and advanced ankylosing spondylitis.
Inclusion criteria: inclusion criteria

 Active and severe ankylosing spondylitis

 Ankylosing spondylitis refractory to standard anti-rheumatic treatment

 Between 18 and 70 years of age

Exclusion criteria:

 Prior exposure to any TNF-inhibitor, including etanercept

 DMARDs (other than hydroxychloroquine, methotrexate and sulphasalazine) within 4 weeks of study drug initiation

 Dose of NSAIDs changed within two weeks of study drug initiation


Study of Adherence and Effects of Balance Exercices (SIEL BLEU Associatio)

Summary: The purpose of this study is to measure the adherence to Siel bleu balance exercises in patients with Alzheimer's disease, while taking into account the disease stages.
Inclusion criteria: inclusion criteria:

 Diagnosis of Alzheimer's disease (AD) (DSM-IV/NINCDS-ADRDA criteria)

 Age ≥ 65 years old

 Mild AD (Mini-Mental State Examination score between 21 and 25), moderate AD (Mini-Mental State Examination score between 10 and 20) and severe AD (Mini-Mental State Examination score between 3 and 9)

 Able to walk without any aid on 15 meters.

 Near visual acuity ≥ 2

 Absence of severe depression (score of the 15-item Geriatric Depression Scale ≤ 10)

 Written consent form to participate in the study (or trustworthy person or legal representative for severe AD)

 Being affiliated to a social security regime

Exclusion criteria: :

 Musculoskeletal disorders not related to Alzheimer's disease

 Near visual acuity < 2

 History of cerebrovascular accident or other cerebro-spinal pathology

 Poor workmanship of the written or oral French language

 Refusal to be informed on possible hanging bare anomaly during study

 Score of Mini-Mental State Examination < 3

 Presence of severe depression (score of the 15-item Geriatric Depression scale > 10)

 Use of walking aid

 Subject suffering from pre-existing impellent disturbances

 Refusal to participate (or trustworthy person or legal representative)

['Gait Apraxia', 'Alzheimer Disease', 'Impaired Cognition']

Gait Apraxia
Alzheimer Disease
Impaired Cognition


The Effect of Donepezil on Sedation and Other Symptoms

Summary: Primary Objective:~1. To determine the effectiveness of donepezil as compared to placebo for the management of opiate-induced sedation/drowsiness in patients with stable cancer pain~Secondary Objectives:~To assess the side-effects in both groups of 1 week treatment of 5 mg donepezil and placebo~To assess the effects of donepezil on fatigue (FACIT-Fatigue), and other symptoms (Anderson Symptom Assessment Scale)~To assess the effects of donepezil on cognition (Symbol Digit Modalities Test)~To assess the effects of donepezil on constipation (number of bowel movements)
Inclusion criteria: inclusion criteria:

 Patient with drowsiness/sedation caused by opiate for > 3 days and its intensity more or equal to 3/10 (0 to 10 scale; 0 = no sedation, 10=worst possible sedation).

 Patient receiving a regular dose of a strong opioid for the treatment of cancer pain, and no dose changes or dose change within 50% for at least 48 hours.Regular administration, defined as short acting opioids oral or parenteral every 4 hours around clock, slow release oral opioids every 12 hs or 24 hs, or transdermal opioids every 72 hours. Strong opioids include morphine, hydromorphone, methadone, fentanyl, and oxycodone.

 Patient with relatively intact cognition defined by the Mini Mental State Examination according to age and educational level. A score of 24 or above is usually considered normal.

 Patient willing to engage in follow up visit with a nurse by phone on day 2-7 (each day), 11 and 15 of the study and to return for follow up visit on day 8 of treatment. If patient is unable to come to clinic, assessment will be performed through telephone.

 Sexually active females at risk of being pregnant with a negative urine pregnancy test

 Written consent form signed.

 Patients are 18 years or older

 Concurrent radiation treatment (defined as 10 or less fractions for a palliative indication) is allowed

 Concurrent chemotherapy is allowed, if the first two cycles have been well tolerated (defined as no grade 3 or 4 non-hematological toxicity)

Exclusion criteria: :

 Major contraindication to donepezil i.e. hypersensitivity to donepezil or piperidine derivatives.

 Patients in whom a major change in opiate dose, analgesia requirements, anesthetic procedures or general anesthetic is expected over the next seven days.

 Treatment with anti-cholinergic agents (i.e., glycopyrrolate)

 Patients taking Methylphenidate.

 Patients with tube feeding (due to difficulty of accurate assessing some of the symptoms such as appetite and anorexia).

 History of ongoing arrhythmia causing a rhythm other than a sinus rhythm


High Definition Endoscopy With i-Scan for Small Colonic Polyp Evaluation: The HiScope Study

Summary: Current standard practice is to remove all colonic polyps found during colonoscopy as it has not been possible to distinguish between polyps with some malignant potential (adenomatous) and those with negligable malignant potential (non-adenomatous).~Recent advances in endoscope imaging and technology have allowed endoscopists to distinguish between these two types of polyps by examining minute surface details.~i-Scan is a new digital enhancement method that aims to enhance surface details and may enable similar accurate distinction between adenomatous and non-adenomatous polyps.~Hypothesis:~High definition white light endoscopy plus i-Scan improves diagnostic accuracy of in-vivo assessment of colonic polyps <10mm in size over high definition white light endoscopy alone.
Inclusion criteria: inclusion criteria:

 Patients found to have colonic polyps up to 10mm in size

Exclusion criteria: :

 Poor bowel preparation

 Inflammatory bowel disease

 Polyposis syndrome

['High definition white light endoscopy']


Clinical Evaluation of QFlu Combo Test

Summary: Currently effective antivials for influenza treatment are two influenza viral neuraminidase inhibitors, oseltamivir (Tamiflu) and zanamivir (Relenza). Resistance to these drugs is reflected by reduced susceptibility of viral neuraminidase to these drugs. The hypothesis is that the signal ratio of two reagents (with or without a single concentration of the drug) correlates the IC50 value, an accurate measurement of drug resistance but impractical for clinical use.
Inclusion criteria: inclusion criteria:

 Those who exhibit flu-like symptom(s) during a flu season and who (or whose guardians) are willing to participate in the study.
Exclusion criteria:

['Cough', 'Myalgia', 'Nasal Obstruction', 'Sore Throat', 'Headache', 'Fatigue', 'Fever']

Cough
Myalgia
Nasal Obstruction
Sore Throat
Headache
Fatigue
Fever


a Multicentric Randomized Controlled Trial of Self-Expandable Esophageal Radiation Stent

Summary: Esophageal cancer is common in some areas , ranking as the fourth leading cause of death from cancer in China and sixth worldwide. Although the prognosis of surgical resection for esophageal cancer has been improved, more than 50% of such patients are inoperable and have to undergo palliative treatments because of late stage cancer or metastasis. Dysphagia is the predominate symptom of patients with inoperable esophageal cancer. To relieve the dysphagia and improve the quality of life of such patients, brachytherapy has previously been utilized. Recently, stent placement has been widely accepted to be an option for palliation of the symptoms due to the esophageal strictures. Brachytherapy and esophageal self-expanding stent insertion have longer benefit. Stent insertion provides fastest improvement of dysphagia.However, recurrence of the neoplastic stricture remains a challenge after stent placement, complications in later setting occur and require further endoscopic treatment. Brachytherapy has slower onset of benefit but has fewer complications and longer benefit.To combine the advantages of the immediate relief of the esophageal dysphagia with the stent placement and radiation therapy with brachytherapy, a novel esophageal stent loaded with 125I seeds has been developed in the authors' institute. The technical feasibility and safety with this new stent has been demonstrated to be adequate in a healthy rabbit model. And a small-sample and unicentric prior clinical trial in the authors' institute certificated the novel esophageal stent can relieve the dysphagia caused by advanced esophageal cancer rapidly and improve the quality of life markedly. This current multicentric randomized clinical trial is further studying the novel esophageal stent loaded with 125I seeds to see how well they work compared with a conventional covered stent in patients with malignant dysphagia caused by advanced esophageal cancer.
Inclusion criteria: inclusion criteria:

 Endoscopically and histologically confirmed cancer of esophagus

 Progressive dysphagia caused by esophageal cancer, and the dysphagia grade of level Ⅲ or level Ⅳ[STOOLER stand]

 In barium meal of esophagus, severe stricture of the cancer make the barium difficult to pass through and the superior normal esophagus broaden

 The bulk and shape of the oesophageal cancer displayed by CT three-dimensional reconstruction

 Patients with clear consciousness，Cooperation，ECOG performance status of 0,1 and 3

 Informed consent: authorization and signature

Exclusion criteria: :

 Poor general status,ECOG performance status of 4,

 Dysphagia not caused by esophageal cancer,

 Noncooperation or no authorization and signature.

 The superior border of cancer higher than the seventh cervical vertebrae

 Ulcerative esophageal carcinoma

 Esophageal fistulas,

 WBC less than 3000/mm3

 Severe hepatic inadequacy or renal inadequacy,

['novel stent', 'conventional covered stent']


COPD Research Registry

Summary: The COPD Research Registry is a confidential database of individuals diagnosed with COPD or at risk of developing COPD. The Registry was established in 2007 by the COPD Foundation with the purpose of providing a mechanism for researchers to boost enrollment in clinical trials and other research studies. The COPD Foundation is working with National Jewish Health in Denver, Colorado to serve as the Registry's Data Coordinating Center and to ensure strictest confidentiality of participant information.
Inclusion criteria: inclusion criteria:

 -Individuals over the age of 18 who have COPD or may be considered to be at increased risk for development of COPD.

Exclusion criteria: :

 -Individuals under the age of 18

['Chronic Obstructive Pulmonary Disease (COPD)']


rhTSH, Thyroid Size, and Radioiodine Therapy in Benign Goiter

Summary: The trials in this protocol deals with the effect of pretreatment with rhTSH on radioiodine treatment of thyroid size and function, in patients with nontoxic and toxic nodular goiter. It is an introduction of a novel principle, based on prospective, randomized double blind investigations. Attached to this, we investigate the acute effects of rhTSH on thyroid size (measured by ultrasonography), both in healthy individuals and in patients with nontoxic nodular goiter. Thus, the investigations are divided into 4 categories listed below:~Prospective randomized double blind study of pretreatment with 0.3 mg recombinant human TSH for the effect of radioiodine in nontoxic multinodular goiter.~Prospective randomized double blind study of the pretreatment with 0.3 mg recombinant human TSH for the effect of radioiodine on thyroid size and function in patients with a very large (>100 ml) nontoxic or toxic goiter.~Does administration of 0.9 mg recombinant human TSH affect thyroid function and volume in healthy individuals? A randomized double-blind cross-over trial.~Does administration of 0.3 mg recombinant human TSH affect thyroid function and volume in healthy individuals and in patients with multinodular non-toxic goiter? A randomized double-blind cross-over trial.~As a final note we investigate, in a pilot-study;~The influence of rhTSH on thyroid radioiodine uptake in patients with hyperthyroidism treated with continuous block-replacement therapy.
Inclusion criteria: inclusion criteria:

 Healthy volunteers with an intact thyroid gland

 Patients with nontoxic/subtoxic nodular goiter confirmed by ultrasonography

 Patients with toxic nodular goiter

 Patients with Graves' disease

Exclusion criteria: :

 Treatment with drugs that alter thyroid function or size (the last 3 months prior to inclusion)

 Prior 131I treatment

 Alcohol, medicine or drug abuse

 Pregnancy or lactation

 No safe contraception

 Participation in another clinical trial

 Allergic reaction towards rhTSH

 Fine needle biopsy without valid diagnostic criteria for benign disease

 Suspicion of malignancy, increased ionized serum calcium and/or serum calcitonin

 Incontinence

 Physically or psychic condition that hinders corporation

 Ischemic attack up till 3 months before inclusion

['Recombinant human thyrotropin (Thyrogen)']

['Benign Nontoxic and Toxic Goiter', "Graves' Disease"]

Benign Nontoxic and Toxic Goiter
Graves' Disease


Comparison of Low-Molecular-Weight Heparin (LMWH) and Unfractionated Heparin (UFH) in Combination With Thrombolytic Treatment of Acute Massive Pulmonary Thromboembolism

Summary: Purpose and rationale: Acute pulmonary embolism (PE) is a common and often fatal disease, with an approximately 30% mortality rate without treatment. Treatment is important to reduce mortality and recurrence in acute PE. Therapeutic options for PE include subcutaneous low molecular weight heparin (SC LMWH), intravenous unfractionated heparin (IV UFH), subcutaneous unfractionated heparin and subcutaneous fondaparinux with or without thrombolysis. In the treatment of acute PE, SC LMWH has been shown, at least, as effective and safe as IV UFH [4]. Compared to IV UFH, SC LMWH associated with lower mortality, fewer recurrent thrombotic events and less major bleeding. Current guidelines recommend use of SC LMWH for most hemodynamically stable patients with PE and they say that SC LMWH have not been tested in the setting of acute massive PE.~The purpose of this study is to demonstrate that SC LMWH is as safe as IV UFH in the treatment of acute PE in combination with thrombolytic treatment.
Inclusion criteria: inclusion criteria:

 Adults, age ≥ 18 years

 Patients who have signed the study informed consent form prior to initiation of any study-related procedure.

 Acute massive PE patients who require thrombolytic treatment.

Exclusion criteria: :

 Patients who have a contraindication to use of anticoagulation and thrombolysis, such as active bleeding, stroke, cranial trauma, or neurologic surgery within the preceding 6 months, current pregnancy, major surgery, or biopsy within the preceding 7 days, major trauma within the preceding 10 days, gastrointestinal bleeding within the preceding 1 months during their admission.

 Patients who received any anticoagulation medication prior to admission to the hospital.

['enoxaparin ,alteplase, unfractionated heparin']

enoxaparin ,alteplase
unfractionated heparin

['This Study Will Provide Data Comparing Safety of LMWH Versus UFH in the Treatment of Acute PE Cases Who Require Thrombolytic Treatment.']


Monitoring Renal Blood Flow With Contrast Enhanced Ultrasound During Coronary Angiogram

Summary: Contrast induced nephropathy (CN) is a common cause of acute kidney injury and is associated with increased morbidity and mortality and healthcare cost. Iodinated contrast media (ICM) induce kidney injury through vasoconstriction and ischemia as well as direct tubular toxicity. Older subjects, individuals with preexisting kidney disease, diabetes, hypotension, and those exposed to higher volumes of ICM are at higher risks for CN. Within the last several years, multiple strategies have been used in clinical studies to reduce the risk of CN in high risk individuals with inconsistent results. In general, it is agreed that volume expansion is effective in reducing the risk. However, no study has looked at changes in renal blood flow (RBF) in response to volume expansion or after exposure to ICM to investigate its relationship with occurrence of CN.~In this proposal, up to 125 individuals with preexisting kidney disease as evidenced by an estimated glomerular filtration rate (eGFR) between 30 - 60 ml/min/1.73 m2 and up to 25 individuals with normal renal function (total of up to 150 individuals) who are scheduled for coronary angiography will be studied. Each individual will have serial measurements of RBF; at baseline, after volume expansion with normal saline, and after exposure to ICM, using the novel technique of contrast enhanced ultrasound (CEU). The investigators will investigate the utility of monitoring RBF with CEU in predicting the occurrence of CN (a rise of > 0.3 mg/dL or 25% in baseline serum creatinine 48 hours after exposure to ICM) after adjusting for other known risk factors in the group of subjects with reduced GFR. The investigators will also examine the correlation between RBF changes and other urinary and serum biomarkers of kidney injury in this group. Up to 25 individuals with a normal kidney function will be studied in a separate part of the study in which the accuracy of CEU based measurements of RBF will be compared to the RBF and blood flow velocity obtained simultaneously using a Doppler flow probe placed directly inside the main renal artery during coronary angiogram procedure. Total to enroll = 150.
Inclusion criteria: Inclusion For specific aim 1 - Subjects with reduced kidney function

 Adult (>18 years of age) men and women

 All races and ethnicities

 Chronic kidney disease stage 3 with an estimated GFR by MDRD formula between 30 - 59 ml/min/1.73 m2

 Being scheduled for a coronary angiography study as part of their clinical care

 For specific aim 2 - Subjects with normal kidney function

 Adult (>18 years of age) men and women

 All races and ethnicities

 Being scheduled for a coronary angiography study

 Estimated GFR greater than or equal to 60 ml/min/1.73 m2

 Exclusion For specific aim 1 - Subjects with reduced kidney function

 Estimated GFR greater than 60 or below 30 ml/min/1.73 m2

 History of kidney transplantation

 Known history of a right to left intracardiac shunt

 Pregnancy or lactation

 History of allergies to Definity®

 History of Pulmonary Hypertension

 For specific aim 2 - Subjects with normal kidney function

 Estimated GFR less than 60 ml/min/1.73 m2

 History of kidney transplantation

 History of a right to left intracardiac shunt

 Pregnancy or lactation

 History of allergies to Definity®

 History of recent major bleeding

 History of allergy to heparin or heparin-induced thrombocytopenia

 History of renal artery stenosis

 Evidence of renal artery stenosis during the placement of Doppler wire in the renal artery

 History of Pulmonary Hypertension
Exclusion criteria:

['Contrast Induced Acute Kidney Injury']


Effect of Bariatric Surgery on Obstructive Sleep Apnea in a Danish Cohort

Summary: Studies have shown high prevalence (60-94%) of obstructive sleep apnoea (OSA) among patients undergoing bariatric surgery.~Fifteen studies are published investigating the effect of bariatric surgery on OSA. All of them conclude a highly positive effect on OSA by bariatric surgery and weight loss. However these studies are biased by a huge number of drop outs. The drop out rate in the studies are around 60 percent.~The Investigators state that the prevalence of OSA among patients undergoing bariatric surgery in Denmark is high. The Investigators state that the effect of bariatric surgery is significant on severity of OSA. The Investigators state that we can perform a study without a huge number of dropouts.
Inclusion criteria: inclusion criteria:

 BMI > 35

 attending bariatric surgery

Exclusion criteria: :

 retrognathia

 micrognathia,

 acromegaly

 downs syndrome


GE Healthcare VolumeRAD Lung Nodule Detection Study

Summary: To perform a multiple reader, multiple case (MRMC) observer study assessing the detection performance of VolumeRAD tomosynthesis of the chest in detecting lung nodules.
Inclusion criteria: inclusion criteria:

 Scheduled for chest CT as part of their needed medical care;

 If available, individuals who have had previous imaging to suggest they fulfill the needs of the study;

 18 years of age, or older;

 In good enough physical condition to stand motionless and hold their breath during the image acquisition procedures.

Exclusion criteria: :

 Children under 18 years of age;

 Women who are pregnant or who suspect they may be pregnant;

 Individuals who on previous imaging are shown to have objects in or around the lungs that might produce substantial artifacts that would obscure pulmonary nodules;

 Individuals who on recent imaging had active lung or pleural disease that would obscure pulmonary nodules;

 Individuals with more than 5 pulmonary nodules between 5mm and 20mm in diameter in either right or left lung.

 Individuals suspected to have more than 15 total nodules between 3mm and 20mm. NOTE that up to 20 nodules between 3mm and 20mm will be allowed in the final study sample.

['Pulmonary Nodule, Solitary', 'Multiple Pulmonary Nodules']

Pulmonary Nodule
Solitary
Multiple Pulmonary Nodules


Education Bundle to Decrease Patient Refusal of VTE Prophylaxis

Summary: The investigators have recently developed a registry of missed doses of VTE prophylaxis that includes retrospective data on missed doses of VTE prophylaxis. To decrease rates of VTE prophylaxis refusal, the group has developed a patient-centered education bundle that will be delivered as an in-person, 1-on-1 discussion session with a nurse educator. Supporting education materials include a 2-page education sheet and an educational video.~The investigators hypothesize that patient refusal of VTE prophylaxis is associated with significant knowledge gaps among patients regarding patients' risk of developing VTE and the benefits of VTE prophylaxis and that delivering an education bundle to patients that refuse VTE prophylaxis will improve compliance with VTE prophylaxis and decrease rates of VTE.
Inclusion criteria: inclusion criteria:

 All patients on the four trial floors who miss at least one dose of VTE prophylaxis will be included in the study.

Exclusion criteria: :

 N/A

['Venous Thromboembolism', 'Deep Venous Thrombosis', 'Pulmonary Embolism']

Venous Thromboembolism
Deep Venous Thrombosis
Pulmonary Embolism


Impact of Unenhanced Computed Tomography (CT) in Elderly Patients Admitted to the Emergency Department With Acute Abdominal Pain

Summary: The purpose of this study is to determine whether non-contrast abdominal computed tomography (CT) impacts management (diagnosis, need for surgery and treatment) in elderly patients admitted to the emergency department with abdominal pain.
Inclusion criteria: inclusion criteria:

 Elderly patients admitted to the emergency department (aged 75 year old and older)

 acute abdominal pain

 informed consent

Exclusion criteria: :

 traumatic pain

 symptom duration of more than a week

 unability for the patient to give informed consent

['Unenhanced abdominal Computed Tomography']


The Influence of Psychobiological Adversity to Children and Adolescents With Type 1 Diabetes

Summary: The aims of this study are two fold: To show whether there is an increased environmental or genetic susceptibility to stress in patients with T1D and whether it influences diabetes management. And to develop a strategy for the assessment and treatment of patients with T1D and an increased risk for development of psychopathology under stress.
Inclusion criteria: inclusion criteria:

 Informed consent signed by a parent/legal guardian and informed assent signed by the study participant prior study entry

 Diagnosed with Type 1 DM prior to signature of Patient Informed Consent (PIC) (for the T1D group).

 Age between 8-15 years old (inclusive) at signature of PIC

 Treated by the investigator's centre prior signature of PIC (For the T1D group).

 Willing to undergo all study procedures

Exclusion criteria: :

 Any documented concomitant chronic disease known to affect diabetes control (e.g. altered renal function, active cancer undergoing treatment, Crohn's disease, ulcerative colitis, Mb Addison disease)

 Any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol (e.g. intellectual disability).

['Psychological background determinations', 'Genetic susceptibility determination', 'Cortisol release test', 'Saliva cortisol measurement']

Psychological background determinations
Genetic susceptibility determination
Cortisol release test
Saliva cortisol measurement


The Mobile Diabetes Mgmt. Study With Type 2 Diabetes

Summary: A Multi-center, Randomized, Parallel, Open Clinical Trial to Evaluate the Glycemic Control Effect of the Mobile Healthcare Service Using U-Healthcare Clinical Decision Support System (CDSS) and U-Healthcare Gateway in Patients with Type 2 Diabetes Mellitus
Inclusion criteria: inclusion criteria:

 20-80 years of age

 Type 2 diabetes patients (who have taken stably oral diabetic drugs or insulin, and been doing lifestyle improvement by doctor's advice for recent over 3 months)

 in case insulin treated, patients with basal insulin once a day or premixed insulin twice a day

 HbA1c between 7.0% and 10.0%

 ability to understand and use smartphone application

Exclusion criteria: :

 type 1 diabetes or patients using insulin pump

 severe complications (stage IV,V chronic kidney failure, diabetic food complications, unstable angina pectoris, MI or stroke, surgical procedure of coronary & peripheral artery within recent 6 months)

 uncontrolled hypertension

 pregnant woman, fertile woman who will not use contraception

 unable to use application during treatment

 taking medication which can affect on glucose level

 alcohol abuse or dependency

 over 2.5 times from the upper limit of liver enzyme level

 DKA(diabetic ketoacidosis) or HHS(Hyperglycemic hyperosmolar syndrome) history during recent 6 months

['Traditional care with paper', 'Health-on G App. + Physician Web']

Traditional care with paper
Health-on G App. + Physician Web


Functional Lipids and Appetite Regulation

Summary: To evaluate the short-term effects of structured lipids on appetite regulation.
Inclusion criteria: inclusion criteria:

 healthy males

 Normal weigh, e.i. BMI between 18,5-25 kg/m2

 age 18-40 years

Exclusion criteria: :

 donation of blood 3 monhts prior or during the study

 gastrointestinal disorders, diabetes, hypertension, hyperlipidemia, chronic infectious disease

 smoking

 consumption of more than 21 alcoholic drinks/week

 elite athletes

 on mediation

 diet supplements


Screening and Identification of Biomarkers on Cervical Cancers

Summary: Cervical cancer the most frequent neoplasm and the fifth mortality rate of malignancies of the women in the world. It results in about 1,000 women in Taiwan and about 200,000 women worldwide dying of cervical cancer each year. Human papilloma viruses (HPV) have been consistently implicated in causing cervical cancer especially those high-risk types (HPV 16,18,31,45) have been strongly associated with cervical cancer. Around 50-80 % of women are infected by HPV within their whole lives. However, only 1% of HPV-infected women have cervical cancer eventually. Seventy and 91% of HPV infection could be cleaned up by host immune responses within 1 and 2 years later. It shows that host immunity plays an important role in the progression, persistence, or regression of HPV infection.~There are two main defense lines in the host immunity including innate immunity and adoptive immunity. Adoptive immunity plays more important roles in the defense of HPV infections than innate immunity. The adoptive immunity could be further divided into humoral immunity and cell-mediated immunity. Humoral immunity regulated by Th2 helper T lymphocytes to generate memory B cells to produce antibody which provide the protective function to HPV infection. Cell-mediated immunity regulated by Th1 helper T lymphocytes to induce antigen-specific cytotoxic T cells which could kill the HPV-infected cells. Although there are many researches focused on the immunity to HPV infection, there is no conclusion about the relationship between humoral and cell-mediated immunities on HPV infection and roles of humoral and cell-mediated immunities in the prognosis of HPV-infected population and cervical cancer patients.~Our research team has focused on the establishment of platforms on cell-mediated immunity to HPV infection and on the correlation of cell-mediated immunity and prognosis of HPV-infected population and cervical cancer patients for years. In order to survey the host immunity to HPV infection more comprehensively, we propose this 3-year proposal. First, we would like to set up the platforms to survey the humoral immunity to HPV infection in normal population and patients with CIN lesion or cervical cancer. Second, we would to elucidate the correlation between humoral immunity and status and clinico-pathologic items of HPV-infected populations. Third, we would like to survey if the humoral immunity correlate with the prognosis of patients with cervical lesions. Fourth, we would like to elucidate the correlation betweenHLA haplotype and humoral immunity in HPV-infected populations. Our research results will have a more comprehensive overview in the host immunity to HPV infection and its related diseases. It could provide more information in the prevention and treatment of HPV infection in the future.
Inclusion criteria: inclusion criteria:

 Healthy volunteers

 People infected with HPV type 16 but without CIN lesions

 Patients with CIN lesions

 Patients with cervical cancer from National Taiwan University Hospital

 Informed consent is obtained, and the protocols are reviewed and approved by the appropriate Investigative Review Boards.

Exclusion criteria: :

 None


The Hypertension in the Very Elderly Trial (HYVET)

Summary: The purpose of this study is to assess the benefits and risks of treating very elderly (those aged 80 or older) individuals with hypertension.
Inclusion criteria: inclusion criteria:

 Aged 80 or older

 Sitting systolic BP 160-199 mmHg AND sitting diastolic BP < 110 mmHg

Exclusion criteria: :

 Known accelerated hypertension (retinal haemorrhages or exudates or papilloedema).

 Overt clinical congestive heart failure requiring treatment with a diuretic or angiotensin converting enzyme inhibitor. Subjects allowed if treated with digoxin only.

 Renal failure (serum creatinine of more than 150 µmol/l).

 Previous documented cerebral or subarachnoid haemorrhage in the last 6 months. (Ischaemic cerebral and cardiac events do not exclude, although the patient must be neurologically and cardiologically stable.)

 Condition expected to severely limit survival, e.g. terminal illness.

 Known secondary hypertension (e.g. renal artery stenosis, chronic renal insufficiency, and endocrine cause).

 Gout.

 Clinical diagnosis of dementia.

 Resident in a nursing home, i.e. where the dependency and care requirements of the patients are such that they require the regular input of qualified nurses and therefore the majority of staff in the home are nurses (other forms of residential care are acceptable).

 Unable to stand up or walk

 Participation in a drug trial within the past month preceding selection.

 Alcohol or drug abuse.

 Less than 2 months placebo run-in.

 Contraindications to use of trial drugs

['Indapamide SR 1.5mg; Perindopril 2-4mg']


Procalcitonin Level and Kinetics in Children With Bacterial Infections

Summary: The purposes of this study are:~To determine whether procalcitonin level at admission of pediatric patients with bacterial infections can be used as a marker for prediction of defervescence and hospitalization length~To examine the kinetics of procalcitonin in pediatric patients with bacterial infections and persistent fever
Inclusion criteria: inclusion criteria:

 Positive blood, urine, synovial, bone, pleural effusion, abscess or CSF culture

 Cellulitis, lobar pneumonia, osteomyelitis,
Exclusion criteria:

['Bacterial Infections', 'Bacteremia', 'Meningitis', 'Urinary Tract Infection', 'Mastoiditis', 'Lobar Pneumonia', 'Septic Arthritis', 'Cellulitis', 'Osteomyelitis']

Bacterial Infections
Bacteremia
Meningitis
Urinary Tract Infection
Mastoiditis
Lobar Pneumonia
Septic Arthritis
Cellulitis
Osteomyelitis


S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer

Summary: RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer.~PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Patients must have a histologically confirmed diagnosis of invasive breast carcinoma with positive estrogen (ER)- and/or progesterone-receptor (PR) status, and negative human epidermal growth factor receptor (HER)2, for whom standard adjuvant endocrine therapy is planned

 ER and PR positivity must be assessed according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines as either ER or PR ≥ 1% positive nuclear staining

 HER2 test result negativity must be assessed as per ASCO/CAP 2013 guidelines using IHC, ISH or both.

 HER2 is negative if a single test (or all tests) performed in a tumor specimen show:

 IHC negative (0 or 1+)

 ISH negative using single probe or dual probe. If IHC is 2+, evaluation for gene amplification (ISH) must be performed and the ISH must be negative; ISH is not required if IHC is 0 or 1+.

 HER2 equivocal is not eligible.

 Patients must not have metastatic breast cancer (stage IV disease); patients with multifocal, multicentric, and synchronous bilateral, and primary inflammatory breast cancers are allowed

 Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant

 Multicentric disease is defined as more than one invasive cancer ≥ 2 cm from the largest lesion within the same breast quadrant or more than one lesion in different quadrants

 Synchronous bilateral disease is defined as invasive breast cancer with positive lymph nodes (axillary or intramammary) in at least one breast, diagnosed within 30 days of each other

 Patients must be high risk by belonging to one of the following risk groups:

 Completion of adjuvant chemotherapy and pathologically negative axillary nodes, and a tumor measuring ≥ 2 cm in greatest diameter, and an Oncotype DX® recurrence score (RS) > 25 (completed as standard of care). Patients with micrometastases as the only nodal involvement (pN1mi) are eligible, and will be categorized as node-negative.

 Completion of adjuvant chemotherapy, and pathologically 1-3 positive lymph nodes, and either an Oncotype DX® RS > 25 (screened via S1007 or otherwise) or tumor tissue with pathological Grade III following local practice. If Oncotype DX is done, then RS must be > 25. If the test is not done, but the patient has Grade III disease then the patient is eligible and Oncotype DX does not need to be performed.

 Completion of adjuvant chemotherapy and pathologically 4 or more positive lymph nodes.

 Completion of neoadjuvant chemotherapy and 1 or more positive nodes pathologically determined prior to or after chemotherapy

 Patients must have completed either breast-conserving surgery or total mastectomy, with negative margins and appropriate axillary staging; a negative margin is defined as no evidence of tumor or ductal carcinoma in situ (DCIS) at the line of resection; additional operative procedures may be performed to obtain clear margins

 Patients who had breast-conserving surgery must have completed whole-breast radiation; use of regional nodal-basin radiation will be at the discretion of the investigator according to institutional guidelines

 Patients with ≥ 4 positive lymph nodes must have completed breast/chest wall and nodal-basin radiation therapy according to standard-of-care guidelines before randomization; omission of radiation therapy is not allowed in this high-risk population of patients

 Patients must be registered no sooner than 21 days after completion of radiation therapy and must have recovered (≤ grade 1) from any of the effects of radiation

 Patients must have undergone axillary staging by sentinel-node biopsy or axillary lymph node dissection (ALND)

 For patients with 1-3 positive lymph nodes, sentinel-node biopsy alone is allowed provided that the patient completed either whole-breast or chest-wall radiation and the primary tumor is < 5 cm

 All patients with ≥ 4 positive lymph nodes must have completed ALND (with or without prior sentinel-node biopsy)

 PATIENT CHARACTERISTICS:

 Absolute Neutrophil Count ≥ 1,500/mL

 Hemoglobin ≥ 9 g/dL

 Platelet count ≥ 100,000/mL

 Bilirubin ≤ 1.5 mg/dL (≤ 3.0 mg/dL if due to Gilbert syndrome)

 Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 times institutional upper limit of normal (IULN)

 Alkaline phosphatase ≤ 1.5 times IULN

 Serum creatinine level ≤ IULN

 Fasting cholesterol ≤ 300 mg/dL and triglycerides ≤ 2.5 times IULN; patients may be on lipid-lowering agents to reach these values

 Patients must have a performance status of 0-2 by Zubrod criteria

 Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia

 Patients previously diagnosed with diabetes must not have uncontrolled diabetes (defined as a hemoglobin [Hg] A1C > 7% within 28 days prior to registration)

 Patients known to be human immunodeficiency virus (HIV) positive may be enrolled if baseline CD4 count is > 500 cells/mm³ and they are not taking anti-retroviral therapy

 Patients with known hepatitis are not eligible

 Patients must not have any known uncontrolled, underlying pulmonary disease

 Patients must be able to take oral medications

 Patients may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of blinded drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)

 Patients must not be pregnant or nursing

 Women/men of reproductive potential must have agreed to use an effective non-hormonal contraceptive method during and for 8 weeks after completion of study therapy

 In addition to routine contraceptive methods, effective contraception also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; corresponding procedures for men include castration, vasectomy, and barrier-contractive devices

 If at any point a previously celibate patient chooses to become heterosexually active during the protocol therapy, he/she is responsible for beginning contraceptive measures

 No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years

 PRIOR CONCURRENT THERAPY:

 See Disease Characteristics

 Patients must have completed standard neoadjuvant or adjuvant chemotherapy prior to randomization; completion of chemotherapy will be determined by the treating oncologist, but should include a minimum of 4 cycles (a cycle of weekly paclitaxel is considered 3 doses); patients must be registered within 42 weeks after the last dose of chemotherapy; patients may have started endocrine therapy at any time after the diagnosis of the current breast cancer

 Patients must not be receiving or planning to receive trastuzumab

 Concurrent bisphosphonate therapy is allowed

 Patients must not have prior exposure to mTOR inhibitors (rapamycin, everolimus, temsirolimus, deforolimus)

 Patients must not have prior treatment with any investigational drug within the preceding 28 days and must not be planning to receive any other investigational drug for the duration of the study

 Patients must not be planning to receive any other anticancer drug for the duration of the study

 Patients must not have an organ allograft or other history of immune compromise; patients must not be receiving chronic, systemic treatment with corticosteroids or other immunosuppressive agent; topical or inhaled corticosteroids are allowed

 Patients must not have received immunization with an attenuated live vaccine (e.g., intranasal influenza, measles, mumps, and rubella [MMR], oral polio, varicella, zoster, yellow fever, and Bacillus Calmette-Guérin [BCG] vaccines) within seven days prior to registration nor have plans to receive such vaccination while on protocol treatment

 Patients must not have taken within 14 days prior to registration, be taking, nor plan to take while on protocol treatment, strong cytochrome P450 3A4 (CYP3A4) inhibitors and/or CYP3A4 inducers
Exclusion criteria:

['anastrozole', 'everolimus', 'exemestane', 'goserelin acetate', 'letrozole', 'leuprolide acetate', 'tamoxifen citrate', 'placebo']

anastrozole
everolimus
exemestane
goserelin acetate
letrozole
leuprolide acetate
tamoxifen citrate
placebo


Electroencephalography (EEG) Biomarkers of Response in Depression

Summary: There are two specific aims of this project:~To identify physiologic indicators of venlafaxine treatment response using quantitative EEG (QEEG) cordance, and to determine if cordance changes are specifically associated with response to venlafaxine~To identify predictors of placebo response in major depression using QEEG cordance/bispectral index (BIS) and neuropsychological testing
Inclusion criteria: inclusion criteria:

 All subjects will meet DSM-IV criteria for depression on the basis of a SCID-P interview, with subjects having a score on the 17-item Ham-D > 17 (with item #1 > 2).

 Subjects will meet criteria both at recruitment and after a one-week single blind placebo wash-in. Study includes outpatients only.

Exclusion criteria: :

 All subjects will have no serious medical illness. The investigators will exclude patients also meeting criteria for the following groups of axis I diagnoses:

 delirium or dementia

 substance-related disorders

 schizophrenia or other psychotic disorders, or eating disorders.

 In addition, patients meeting criteria for cluster A or B axis II diagnoses will be excluded.

 Subjects with a history of current or past active suicidal ideation, or suicide attempts will be excluded from the study.


Assessment of Lesion Activity Analysis in the Avonex- Steroid Azathioprine (ASA) Study

Summary: To examine short- and long-term value of appearance of new active lesions in predicting extent of cortical and subcortical deep gray matter (SDGM) atrophy over 5 years in ASA (Avonex- Steroid-Azathioprine)study.~To explore how accumulation of cortical and SDGM atrophy over 5 years differs with respect to the number of new active lesions or amount of disease activity, in early relapsing-remitting multiple sclerosis (RRMS) patients who did or did not develop sustained disability progression.~To examine the relationship between development of cortical and SDGM atrophy and regional likelihood of development of new active lesions over 5 years.
Inclusion criteria: inclusion criteria:

 Enrolled into the 2-year, double-blind, placebo-controlled ASA study and entered 3 year extension study

 MRI was performed on all patients using a 1.5 T magnet

Exclusion criteria: :

 MRI images unable to be processed

 All 5 MRI time points not collected


Study of a Community Based Approach to Control Cardiovascular Risk Factors in India

Summary: The study is a 2 year community based cluster randomized controlled trial to assess the role that a community health worker led intervention, in concert with physician education, can play in controlling the principal cardiovascular risk factors, i.e. hypertension, tobacco use, diabetes mellitus, physical inactivity and an unhealthy diet. Participants will include around 3600 adults, 35-70 years of age, from the urban community in the town of Dalkhola, Uttar Dinajpur district, West Bengal, India. The hypothesis of the study is that a community health worker based approach can result in increased control of Hypertension, Diabetes and Smoking.
Inclusion criteria: inclusion criteria:

 All individuals between the ages of 35 and 70 and residing in the area allotted to the CHW will be offered screening.

 Of the screened individuals, those with at least 1 cardiovascular risk factor (either one of Hypertension (BP>140/90), Diabetes (FBG >126) or current daily smoker (self-reported) will be enrolled in the study.

Exclusion criteria: :

 Individuals who are bed-bound because of acute illness, or have a chronic condition that makes them bed-bound.

 Individuals who refuse consent

 Individuals who do not reside in the community and are only visiting, therefore being unlikely to be available for continuous follow up. Individuals who have stayed less than 6 months in the study area, or whose name is not on the voter list of the area will be excluded.

 Individuals who are not able to participate in the intervention due to significant disabilities, such as blindness, deafness or the intellectually disabled.

['Hypertension', 'Diabetes', 'Smoking', 'Cardiovascular Diseases']

Hypertension
Diabetes
Smoking
Cardiovascular Diseases