Efficacy of Functional Electrical Stimulation (FES) in Persons Receiving Botulinum Neurotoxin for Upper Extremity Spasticity

Summary: FES is a form of treatment with a device to aid movement in people who have had damage to their brain or spinal cord. Small electrical impulses are used to excite/stimulate the nerves that supply paralyzed muscles. This activates those muscles, enabling them to produce basic but useful movement. Self-adhesive patches (electrodes) are placed on the skin close to the nerve that supplies the muscle and are connected by wires to a stimulator that produces the impulses. In this way, FES is used to correct the muscle weakness that is caused by injury to the brain or spinal cord.~Repetitive task practice is an activity-based therapy program that has been shown to enhance the recovery of hand and arm functions after stroke. This therapy consists of a set of training activities that are designed by a qualified therapist specific to your functional abilities that are to be performed with the impaired hand. These activities are designed to stimulate functional improvement with repetitive practice.~Spasticity is a nervous system disorder where certain muscles are continuously contracted. Botox injections are commonly used to help to reduce spasticity in areas of the body with increased muscle tone. This research is designed to look at any additional benefit that may occur when Botox injections are combined with specific occupational therapy exercises and with a device that uses functional electrical stimulation (FES) to help improve muscle function after stroke.
Inclusion criteria: inclusion criteria:

 Minimum 6 months post injury/insult with unilateral upper limb spasticity of the elbow, wrist and/or finger flexors.

 Preinjection Modified Ashworth scores > 2 in at least one of the following areas: elbow, wrist, or finger flexors.

 Subjects must meet criteria for CMA Hand Impairment Scale Stage 2 and be able to complete Task 3 (thumb to index finger) of the CMA Hand Impairment Scale Stage 3, or demonstrate 50% gross grasp to be included.

 Botulinum toxin A (Botox®) stable patients (have received at least two prior doses of the agent with first dose occurring at least 6 months prior to study enrollment).

 Able to answer reliably to yes/no questions.

 Able to follow reliably 1-step instructions.

 Written informed consent.

 Females enrolled in this study who are of childbearing age will be required to use adequate measures of birth control for the entire study period. Those who do not agree will be excluded.

Exclusion criteria: :

 Uncontrolled, clinically significant medical condition other than the condition under evaluation.

 Severe, fixed joint contracture in the affected arm. Patients with mild contracture that does not significantly impact function will be included based upon the assessment of the PI.

 Known allergy or sensitivity to any of the components in the study medication.

 Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.

 Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment.

 Treatment with botulinum toxin of any serotype for any reason in less than 3 months prior to initial date of injection for the study.

 Any medical condition that may put the subject at increased risk with exposure to botulinum toxin type A including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function.

 Evidence of recent alcohol or drug abuse.

 Infection or skin disorder at an anticipated injection and/or electrical stimulation sites.

 Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.

 Use of aminoglycoside antibiotics, curare like agents, or other agents that might interfere with neuromuscular function.

 Individuals with a cardiac pacemaker, a defibrillator, or baclofen pump.

 Individuals with an unhealed or healing fracture or dislocation in the arm to be evaluated.

['Functional Electrical Stimulation (FES) through the Ness H200']

['Upper Extremity Spasticity', 'Stroke', 'Acquired Brain Injury']

Upper Extremity Spasticity
Stroke
Acquired Brain Injury


Percutaneous Image Guided Video-Assisted Thoracic Surgery (VATS) Resection of Lung Lesions

Summary: This is a phase II protocol to determine the safety and feasibility of Intraoperative CT fluoroscopy guidance for lung resection for small nodules.
Inclusion criteria: inclusion criteria:

 peripheral lung nodules < 3cm in size

 Surgical candidate

Exclusion criteria: :

 Non surgical candidate

['Video-Assisted Thoracic Surgery (VATS) wedge resection']


Intraperitoneal Analgesia After Laparoscopic Cholecystectomy

Summary: Although laparoscopic cholecystectomy is associated with less pain than contemporary open procedures; it is definitely not pain free and the magnitude of postoperative shoulder and abdominal pain in the early postoperative period is still quite significant. This postoperative pain is a major concern not only for the patients, but also healthcare workers; and it often contributes to overnight hospital stay after this minimally invasive surgical procedure. Intraperitoneal instillation of local anesthetics at the time of surgery to control pain after laparoscopic cholecystectomy has been extensively studied in numerous randomized trials and found to be extremely useful. Lignocaine and Bupivacaine are two commonly used local anesthetic agents. In view of contradictory results from previous studies, it is not yet clear which of these two agents is superior to the other for pain control in this setting. To answer this question, we have designed a prospective randomized controlled trial and the specific aim of the study is to compare the analgesic efficacy of intraperitoneal lignocaine with intraperitoneal Bupivacaine in the postoperative setting after laparoscopic cholecystectomy.~If we can improve pain control after this minimally invasive procedure, it might result in decreased postoperative requirement of narcotic analgesia and its associated side-effects. It may also result in early recovery and the same day discharge of the patients with significant cost-containment for the patient and healthcare systems in future.
Inclusion criteria: inclusion criteria:

 Diagnosis of symptomatic gallstones requiring laparoscopic cholecystectomy

 Elective surgical procedure

 American Society of Anesthesiologists class I and II

Exclusion criteria: :

 Patients refusing randomization

 Patients already on analgesics

 Patients with acute cholecystitis

 Patients requiring preoperative cholangiogram or common bile duct exploration

 Patients having bile or stone spillage during procedure

 Patients requiring conversion to open procedure

 Patients requiring re-exploration for any reason

 Patients with history of allergy to local anesthetic agents


A Comparison Between Signature Total Knee Arthroplasty (TKA) to Conventional TKA and Computer Assisted TKA

Summary: This is a prospective, randomised clinical outcomes study comparing the Signature Personalised Patient Care, Conventional Total Knee Arthroplasty and Computer Assisted Navigation, using Vanguard Knee System. The aim of the study is to evaluate the safety and efficacy of TKA using Signature Personalised Patient Care compared to Conventional TKA and Computer Assisted Navigation.
Inclusion criteria: inclusion criteria:

 Patient is of legal age and skeletally mature

 Patient requires primary total knee arthroplasty due to non- inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, a vascular necrosis, dysplasia/DDH) or inflammatory joint disease (e.g., Rheumatoid arthritis).

 Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, haematological, etc., conditions that would pose excessive operative risk

 The patient will be available for follow up throughout the duration of the study.

Exclusion criteria: :

 Patient is unable to have an MRI scan due to the following conditions:

 Cardiac pacemaker

 Surgical clips in head (aneurysm clips)

 Some artificial heart valves

 Electronic inner ear implants

 Metal fragments in eyes

 Electronic stimulators

 Implanted pumps

 Patient has active infection or sepsis (treated or untreated)

 Patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.

 Patient is female of child-bearing age and not taking contraceptive precautions.

 Patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia).

 Patient has known moderate to severe renal insufficiency.

 Patient has a known or suspected metal sensitivity.

 Patient is immunosuppressed or receiving high doses of corticosteroids.

 Patient has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, or drug, alcohol abuse.

 Patient has BMI >40.

['Signature Knee Guide', 'Conventional Instrumentation', 'Computer Assisted Navigation']

Signature Knee Guide
Conventional Instrumentation
Computer Assisted Navigation


A Treatment Study for Premenstrual Syndrome (PMS)

Summary: This study examines the effects of estrogen and progesterone on mood, the stress response, and brain function and behavior in women with premenstrual syndrome.~Previously this study has demonstrated leuprolide acetate (Lupron (Registered Trademark)) to be an effective treatment for PMS. The current purpose of this study is to evaluate how low levels of estrogen and progesterone (that occur during treatment with leuprolide acetate) compare to menstrual cycle levels of estrogen and progesterone (given during individual months of hormone add-back) on a variety of physiologic measures (brain imaging, stress testing, etc.) in women with PMS.~PMS is a condition characterized by changes in mood and behavior that occur during the second phase of the normal menstrual cycle (luteal phase). This study will investigate possible hormonal causes of PMS by temporarily stopping the menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. The results of these hormonal studies will be compared between women with PMS and healthy volunteers without PMS (see also protocol 92-M-0174).~At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy tests will be performed. Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies.
Inclusion criteria: inclusion criteria:

 The subjects of this study will be women who meet the criteria for MRMD as described in Protocol No. 81-M-0126, 'The Phenomenology and Biophysiology of Menstrually-related Mood and Behavioral Disorders.' In brief, these criteria include:

 history within the last two years of at least six months with menstrually-related mood or behavioral disturbances of at least moderate severity--i.e., disturbances that are distinct in appearance and associated with a notable degree of subjective distress;

 symptoms should have a sudden onset and offset;

 age 18-50;

 not pregnant and in good medical health;

 medication free.

 All patients participating in this protocol will have already participated in Protocol No. 81-M-0126 and will have a prospectively confirmed and predictable relationship between their mood disorder and the premenstrual phase of the menstrual cycle, i.e., a 30% change in severity of symptom self rating scales, relative to the range of the scale employed, during the seven days premenstrually compared with the seven days post-menstrually in two out of three months of study.

 The Schedule for Affective Disorders and Schizophrenia will be administered to all patients prior to study entry. Any patient with a current axis I psychiatric diagnosis will be excluded from participating in this protocol.

 Prior to treatment, a complete physical and neurological examination will have been performed and the following routine laboratory data obtained:

 A. Blood

 Complete blood count; thyroid function tests; cortisol; renal function tests, such as blood urea nitrogen (BUN) and creatinine; electrolytes; glucose; liver function tests.

 B. Urine

 Routine urinalysis; urine pregnancy test.

 GnRH agonist will not be administered to any subject with significant clinical or laboratory abnormalities. The blood tests and urinalysis will be repeated 2 weeks after GnRH agonist administration to rule out any evidence of acute renal, hepatic or hematologic toxicity.

 Results of Pap smear performed within one year of the onset of treatment will be obtained.

Exclusion criteria: :

 The following conditions will constitute contraindications to treatment with hormonal therapy and will preclude a subject's participation in this protocol:

 current Axis I psychiatric diagnosis

 history consistent with endometriosis,

 diagnosis of ill-defined, obscure pelvic lesions, particularly, undiagnosed ovarian enlargement,

 hepatic disease as manifested by abnormal liver function tests,

 history of mammary carcinoma,

 history of pulmonary embolism or phlebothrombosis

 undiagnosed vaginal bleeding

 porphyria

 diabetes mellitus

 history of malignant melanoma

 cholecystitis or pancreatitis,

 cardiovascular or renal disease

 pregnancy

 Any woman meeting the Stages of Reproductive Aging Workshop Criteria (STRAW) for the perimenopause. Specifically, we will exclude any woman with an elevated plasma follicle stimulating hormone (FSH) level (>= 14 IU/L) and with menstrual cycle variability of > 7 days different from their normal cycle length.

 Subjects taking birth control pills will be excluded from the study.

 Subjects taking diuretics, prostaglandin inhibitors, or pyridoxine (putative treatments for MRMD) will similarly be excluded from the study

 Patients taking psychotropic agents (e.g., lithium carbonate, tricyclic antidepressants).

 All subjects will be required to use non-hormonal forms of birth control (e.g., barrier methods) to avoid pregnancy during this study.

['Leuprolide', 'Estradiol Patches', 'Progesterone', 'Placebo patch', 'Placebo injection', 'Placebo suppository']

Leuprolide
Estradiol Patches
Progesterone
Placebo patch
Placebo injection
Placebo suppository

['Premenstrual Syndrome', 'Menstruation Disturbances']

Premenstrual Syndrome
Menstruation Disturbances


Safety and Efficacy of the Swallow Expansion Device (SED) for Improvement of Swallowing in Patients

Summary: Biomedical devices, such as artificial joints and pacemakers, are accepted and commonly used in medicine. While great progress in biomedical devices has been made for many other disorders, there is currently no device available to assist with the act of deglutition. The investigators have developed a biomedical device (Swallow Expansion Device, SED) that assists with swallowing by mechanically opening the upper esophageal sphincter and allowing food and liquid to safely enter the esophagus. The SED has proven safe in cadaver and live animal studies (Belafsky, 2010).
Inclusion criteria: inclusion criteria:

 Profound oropharyngeal feeding tube dependent dysphagia of greater than 12 months duration, as documented by the prevalence of aspiration on fluoroscopic swallow study.

 Must be receiving 100% of nutritional requirements by enterogastric tube.

 18 years of age and older, acceptable forms of documentation for verification of age include birth certificate, passport, and/or driver's license.

 Diminished upper esophageal sphincter opening defined as less than .55 cm for individuals under 65 years of age and less than .40 cm for individuals over 65 years of age on fluoroscopic swallow study.

 Failure of > 3 months of dysphagia therapy within 3 months of study enrollment.

 No documented history of noncompliance with feeding recommendations.

 Cognition that is within normal limits, as evidenced by an Abbreviated Mental Test Score (AMTS) score greater than 6.

 Manual dexterity that is within normal limits for age, sex, and hand, as evaluated by a Block and Box Test (BBT).

 Physical strength to pull the SED forward, as evidenced by the ability to lift a 5 lb weight off of a table and keep it elevated for 10 seconds.

 Ability to understand the informed consent and comply with follow-up, as evidenced by appropriate questions, responses, and comments during the initial evaluations and a normal Abbreviated Mental Test Score.

 Bilateral vocal fold mobility or unilateral vocal fold immobility in which the individual is able to attain complete glottic closure as evidenced on endoscopy.

Exclusion criteria: :

 Profound oropharyngeal feeding tube dependent dysphagia < 12 months duration.

 Esophageal phase dysphagia as defined as personal history and/or documented diagnosis of esophageal dysmotility, hiatal hernia, stricture, eosinophilic esophagitis, erosive peptic esophagitis, and/or systemic disease affecting the esophagus.

 Able to safely consume any food or liquid by mouth, as documented by fluoroscopic swallow study.

 Normal UES opening, as evidenced by UES opening greater than .55 cm for individuals under 65 years of age and greater than .40 cm for individuals over 65 years of age on fluoroscopic swallow study.

 Currently pregnant, as evidenced by a positive result on a pregnancy test if the patient is within child bearing age (younger than 60 years of age).

 17 years of age and younger, acceptable forms of documentation for verification of age include birth certificate, passport, and/or license.

 Success full receipt of dysphagia therapy or < 3 months of dysphagia therapy within 3 months of study enrollment.

 Lack of manual dexterity to operate swallowing expansion device as determined by a Block and Box Test (BBT) score below the normal limits per age, sex, and hand.

 Inability to lift a 5 lb weight off of a table and keep it elevated for 10 seconds.

 Lack of cognitive ability to operate swallowing expansion device or provide informed consent as evidenced by an Abbreviated Mental Test Score (AMTS) score less than 6.

 Active tumor involving the cricoid or laryngeal cartilage.

 Known allergic reaction to titanium as evidenced by personal history of allergic or adverse reaction to titanium.

 Infection of cartilage, head, and/or neck at time of evaluation and/or implantation as documented by recent imaging study or abnormal physical examination.

 Presence of a tracheotomy tube or airway obstruction necessitating a tracheotomy tube.

 A documented history of noncompliance with recommendations to take nothing by mouth.

 Patients with an insensate larynx. Laryngeal sensation will be assessed with laryngopharyngeal sensory testing. An insensate larynx is defined as a laryngopharyngeal sensory threshold < 6 mmHg air pulse pressure or a complete absence of the laryngeal adductor reflex on palpation of the arytenoid with a flexible laryngoscope.

 Patients with a current, at the time of evaluation, and/or history of Zenker's diverticulum.

 Patients with sialorrhea at the time of evaluation with or without oral commissure incompetence.

 Patients with profound xerostomia at the time of evaluation.

 Patients with orocutaneous or pharyngocutaneous fistulae at the time of evaluation.

 Patients with a current, at the time of evaluation, and/or history of immunosuppression, as defined by the patient having a diagnosed immunodeficiency disorder or on immunosuppressive medication.

 Patients with a current, at the time of evaluation, and/or history of coagulopathy, as defined by the patient having a diagnosed coagulation disorder or on anticoagulation medication (e.g., baby aspirin, over-the-counter non-steroidal anti-inflammatories, herbal agents, and warfarin, etc.) that cannot be temporarily stopped for the procedure.

 Patients taking sedatives, narcotics, muscle-relaxants, anxiolytics, medical marijuana, alcohol, nicotine, medicinal nicotine, or other mind-altering medications that may affect safe patient use of the swallowing device.

 Patients taking antifibrotic medications.

 Patients with bilateral vocal fold immobility in any position, as evidenced on endoscopy.

 Patients with unilateral vocal fold immobility and unable to attain complete glottic closure, as evidenced on endoscopy.

 Patients with current, at the time of evaluation, and/or documented history of subglottic stenosis, as evidenced on endoscopy.

 Patients with current, at the time of evaluation, and/or documented history of airway obstruction, as evidenced on endoscopy.

 Patients with a life expectancy < 2 years.

['Oropharyngeal Dysphagia (OPD)', 'Dysphagia']


Rituximab as Second Line Treatment for ITP

Summary: Immune thrombocytopenic purpura (ITP) is an autoimmune disorder characterized thrombocytopenia.~Splenectomy is the standard treatment for patients who fails the first-line treatment: corticosteroid. Rituximab, has recently emerged as a promising treatment for ITP. The aim of the study is to determine whether early treatment with Rituximab can result in durable remissions, and consequently, lead to the avoidance of splenectomy in a significant number of patients.
Inclusion criteria: inclusion criteria:

 ITP with platelet count <30 x 109 /l after 2 weeks of treatment with prednisolon or during prednisolon tapering period i.e. from week three of prednisolon initiation. Patients with platelet count between 30 -50 are eligible if a higher platelet count is considered necessary, because of : concomitant medical illness predisposing to bleeding (hypertension, GI bleeding, bleeding diathesis, previous history of bleeding) concomitant medical condition requiring platelet blocking agents/ anticoagulation, persistent bleeding despite platelets > 30 x 109 /l, prior to surgery, or because of other patient related factors necessitating higher platelet count as occupation, hobby, psychological intolerability.

 Subject is >18 years

 Subject has signed and dated written informed consent.

 Subject is able to understand and comply with protocol requirements and instructions, and intends to complete the study as planned.

 Females in fertile age should express willingness for use of contraceptive means for 6 months following the administration of the study drugs.

Exclusion criteria: :

 Previous splenectomy, chemotherapy, treatment with anti-D Ig, rituximab, or immune-suppressive treatments other than corticosteroids, Dapsone or Danazol

 Underlying malignancy or previous history of malignancy in the past 5 years (except skin carcinoma)

 Pregnancy and lactation

 Not willing to participate in the study

 Expected survival of < 2 years

 Known intolerance to murine antibodies

 Females in child-bearing age not willing to use contraception for 6 months

 HIV-positive/AIDS-, Hepatitis -B virus positive- or Hepatitis -C virus positive

 Patients with a definite Systemic Lupus Erythematosus (SLE) (> 4 of the American College of Rheumatology Criteria)

 Patients currently involved in another clinical trial with evaluation of drug treatment

 Bacterial infections, viral infections, fungal infections, myco-bacterial infections (excluding fungal infections) or other evolutive infections or any other infections episode requiring hospitalisation or treatment with an antibiotics 4 weeks before selection for IV route or within 2 weeks before selection for oral route

 History of soft tissue, bone or joint infections (fascitis, abscess, osteomyelitis, septic arthritis) during the last year prior to inclusion in the study

 Medical history of relapsing or chronic severe infectious diseases or any other underlying pathology predisposing to serious infections

 Known Primary or secondary immune deficiency syndromes

 Administration of a living vaccine within 4 weeks preceding the inclusion in the study -16- Previous treatment with any lymphocytes depleting medication (e.g.: MabCampath®)

 17- Previous treatment with inhibitors of leucocytes transmigration (e.g.: Tysabri®) 18- Known intolerance to human monoclonal antibodies 19- Known severe chronic pulmonary obstructive Disease (FEV < 50% or functional dyspnoea grade 3) 20- Known congestive heart failure NYHA (New York Heart Association classification of heart failure) class III and IV 21- Recent episode (<6 months) of acute coronary syndrome.


Early Molecular Detection for the Improved Diagnosis of Invasive Pulmonary Aspergillosis and Invasive Pulmonary Zygomycosis

Summary: Background:~Fungal infections of the lung (pneumonia) can be caused by molds, such as Aspergillus and Zygomycetes, but these causes are often difficult for a doctor to diagnose. Early and accurate diagnosis of these infections can help doctors to select the correct medicines for proper treatment.~A number of methods are used to diagnose fungal pneumonia. Ones that are commonly used in clinical practice include radiographic imaging (chest X-rays and computed tomography (CT) scans), blood tests, and cultures taken from fluid from the lungs (broncho-alveolar lavage (BAL) fluid). Other new methods may improve the diagnosis of fungal pneumonias. These methods include tests that can detect DNA from the fungal germ in blood and BAL fluid of some patients with these infections.~Objectives:~To help develop better and more accurate methods of diagnosing fungal lung infections.~To detect fungal DNA and chemicals in the bloodstream and BAL fluid of immunocompromised patients with pneumonia.~Eligibility:~- Immunocompromised patients who are currently enrolled in another NIH protocol and who have a CT scan that shows a possible fungal infection of the lung.~Design:~Researchers will review patients' existing medical records and CT scans, and current pneumonia treatment plans.~Patients will provide blood and BAL samples for the duration of their treatment for pneumonia, as required by researchers. Additional CT scans will not be performed, except as part of existing treatment plans.
Inclusion criteria: inclusion criteria:

 Patients currently enrolled in any NIH IRB approved Clinical Center protocol or under treatment at the CNMC who are undergoing bronchoscopy or lung biopsy for diagnosis of possible invasive pulmonary aspergillosis or invasive pulmonary zygomycosis.

 Informed consent of the patient or the patient's legally authorized representative.

 Fulfillment of one or more of the following EORTC/MSG host criteria:

 History of neutropenia (ANC < 500/mm(3)) within the past 3 months temporally related to the onset of radiographic changes

 Receipt of an allogeneic HSCT

 Receipt of solid organ transplantation

 Prolonged use of corticosteroids at an average minimum dose of 0.3 mg/kg/day prednisone equivalent for > 3 weeks

 Treatment with other recognized T-cell immune suppressants such as cyclosporine, TNF alpha blockers, specific monoclonal antibodies such as alemtuzumab, nucleoside analogues during the past 90 days

 Myelodysplastic syndrome

 Severe aplastic anemia

 Cushing's disease

 HIV/AIDS

 Primary immunodeficiencies (such as chronic granulomatous disease, severe combined immunodeficiency)

 The presence of one or more of the following signs on chest CT or radiograph:

 Dense well circumscribed lesions with or without a halo sign

 Air crescent sign

 Cavity

 Focal, segmental or lobar infiltrates

Exclusion criteria: :

 Interstitial or diffuse infiltrates on chest CT or radiograph

 Inability to provide informed consent

 Children weighing less than 10 kg

 Any other concomitant condition, which in the opinion of the investigator would place the patient at risk by participating in the study

['Immunocompromised Host', 'Invasive Pulmonary Fungal Infection', 'Invasive Pulmonary Aspergillosis', 'Invasive Pulmonary Zygomycosis']

Immunocompromised Host
Invasive Pulmonary Fungal Infection
Invasive Pulmonary Aspergillosis
Invasive Pulmonary Zygomycosis


Nocturnal Breathing and Sleep in Patients With Chronic Obstructive Pulmonary Disease Staying at Altitude

Summary: The purpose of this study is to evaluate whether nocturnal breathing and sleep of patients with chronic obstructive pulmonary disease (COPD) are disturbed during a stay at moderate altitude.
Inclusion criteria: inclusion criteria:

 chronic obstructive pulmonary disease (COPD), GOLD grade 2-3

 residents at low altitude (<800 m)

Exclusion criteria: :

 Unstable condition, COPD exacerbation

 Mild (GOLD 1) or very severe COPD (GOLD 4)

 requirement for oxygen therapy at low altitude residence

 hypoventilation

 pulmonary hypertension

 more than mild or unstable cardiovascular disease

 use of drugs that affect respiratory center drive

 internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (>20 cigarettes per day), inability to perform 6 min walk test.

 previous intolerance to moderate altitude (<2600m).

 Exposure to altitudes >1500m for >2 days within the last 4 weeks before the study.

 Pregnant or nursing patients

['Chronic Obstructive Pulmonary Disease']


Transcranial Direct Current Stimulation (tDCS) and Cognitive Task in Depression

Summary: Among antidepressant treatments, electroconvulsive therapy (ECT) remains the most effective. However, patient concerns with cognitive side effects have encouraged trials of new, non-convulsive forms of mild brain stimulation such as transcranial Direct Current Stimulation (tDCS). Our past and present studies of tDCS suggest that it has antidepressant effects and is safe, painless and well tolerated. However, not all patients may have an adequate response, raising the need to find ways of optimising efficacy. This clinical pilot study will examine the feasibility and safety of combining tDCS with a cognitive training task which engages the same brain region targeted by tDCS for treatment of depression.
Inclusion criteria: inclusion criteria:

 Participants are aged 18-65 years.

 Participant meets criteria for a DSM-V Major Depressive episode. Criteria are as follows: Five or more symptoms present during the same 2-week period, including either 1 or 2: 1) depressed mood, 2) loss of interest or pleasure, 3) significant weight loss or gain, 4) insomnia or hypersomnia, 5) psychomotor agitation or retardation, 6) fatigue or loss of energy, 7) feelings of worthlessness or excessive or inappropriate guilt, 8) diminished ability to think concentrate or make decisions, and 9) recurrent thoughts of death, recurrent suicidal ideation, suicide attempt or plan.

 MADRS score of 20 or more.

 Right handed

 A history of non-response to ≥ 2 adequate trials of antidepressant medication treatment.

Exclusion criteria: :

 DSM-V psychotic disorder.

 Drug or alcohol abuse or dependence (preceding 6 months).

 Inadequate response to ECT (current episode of depression).

 Regular benzodiazepine medication

 Rapid clinical response required, e.g., due to high suicide risk.

 Clinically defined neurological disorder or insult.

 Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.

 Pregnancy.

['Transcranial direct current stimulation combined with cognitive training']


Microbiome Acquisition and Progression of Inflammation and Airway Disease in Infants and Children With Cystic Fibrosis

Summary: Cystic Fibrosis (CF) is a fatal, recessive genetic disorder characterized by progressive inflammation and lung damage. It is unclear whether current treatment strategies, which focus on detection and eradication of pathogenic microorganisms in the lung, are the best way to prevent the initiation of early inflammation and lung damage. This study asks how early acquisition of microbial flora occurs in infants with CF and healthy baby controls, and whether this process initiates or influences early inflammation and clinical disease progression in CF.
Inclusion criteria: Cystic Fibrosis participants:

 inclusion criteria:

 laboratory diagnosis of Cystic Fibrosis

Exclusion criteria: :

 Major organ system disease other than Cystic Fibrosis

 History of prematurity

 Non Cystic Fibrosis control participants:

 inclusion criteria:

 Proof of a negative newborn CF screening test


Physical Fitness and Nutrition Intake in Bariatric Surgery Population

Summary: The purpose of this research study is to determine how bariatric surgery affects physical activity and nutrient intake.~This research study is being done because the investigators want to determine better recommendations to provide to bariatric surgery patients.
Inclusion criteria: inclusion criteria:

 Competent patients enrolled in the pre- or post-operative bariatric surgery program at the Center for Nutrition and Weight Management at GMC, Danville, PA.

 Ability to perform a 6 Minute Walk Test.

 Aged 18 through 70.

 Willingness to receive dietary recall phone calls and accessibility to a telephone.

Exclusion criteria: :

 Patients with severe lung disease requiring oxygen therapy.

 Pulmonary embolus or pulmonary infarction.

 Patients with cardiopulmonary disease (e.g., prior myocardial infarction, coronary artery bypass, or vascular stent).

 Unstable angina.

 Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise.

 Patients with any health reason that limits walking.

 Patients with a temporary injury that limits walking.

 Patients who use a wheelchair, other assistive device for walking, or have difficulty ambulating during activities of daily living.

 Patients predetermined to be illiterate or incompetent.

 Patients who are currently pregnant or have been pregnant at any time since bariatric surgery.

 Tobacco use.

 Patients with electronic defibrillators or other embedded electronic medical devices.

 Acute systemic infection, accompanied by fever, body aches, or swollen lymph glands

 Patients who have undergone revisional bariatric surgery.


Efficacy and Safety of Eculizumab for Treatment of Antibody-mediated Rejection Following Renal Transplantation

Summary: This is an open-label analysis that will compare eculizumab versus Plasmapheresis (PP) and Immunoglobulin (IVIg) for the treatment of antibody-mediated rejection (AMR) in renal transplant recipients. All patients will be evaluated from the time of AMR diagnosis for 12 months.
Inclusion criteria: inclusion criteria:

 Adult renal transplant recipients, men and women between 18 and 75 years of age.

 Any patient with acute graft dysfunction (elevation of creatinine above post transplant nadir)

 AND, two out of three, of the following inclusion criteria:

 Presence of circulating anti human leukocyte antigen (HLA) antibody (DSA donor specific antibody).

 Histological findings compatible with Banff Class II or III AMR on transplant biopsy.

 Peritubular capillary c4d positivity on transplant biopsy.

Exclusion criteria: :

 Patients that have received eculizumab prior to enrolling in the study.

 Patients with ongoing non-acute antibody mediated rejection.

 Patients with predominantly chronic antibody mediated rejection or interstitial fibrosis/tubular atrophy.

 History of severe cardiac disease (e.g., New York Heart Association [NYHA] Functional Class III or IV, myocardial infarction ≤ 6 months of randomization, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases)

 Prior splenectomy

 Has a known bleeding disorder

 Has any active bacterial or other infection which is clinically significant in the opinion of the Investigator and is a contraindication to transplantation

 Has participated in any other investigational drug study or was exposed to an investigational drug or device within 30 days of screening

 Has received rituximab (Rituxan®) ≤ 3 months prior to screening

 Has received bortezomib (Velcade®) ≤ 3 months prior to screening

 Has received alemtuzumab (Campath®) ≤ 6 months prior to screening

 Need for concurrent treatment with anti thymocyte globulin (Thymoglobulin®)

 Hypersensitivity to murine proteins or to one of the product excipients

 History of illicit drug use or alcohol abuse within the previous year

 Unresolved meningococcal disease

 Pregnancy or lactation

 Current cancer or a history of cancer within the 5 years prior to screening with the exception of patients who have successfully treated non-metastatic basal or squamous cell carcinoma of the skin; carcinoma in situ of the cervix; or breast carcinoma in situ

 Any medical condition that, in the opinion of the Investigator, might interfere with the patient's participation in the study, poses an added risk for the patient, or confounds the assessment of the patient Active infection with Hepatitis B (HBV), Hepatitis C (HCV) or human immunodeficiency virus (HIV)

['Antibody-mediated Rejection', 'Humoral Rejection']

Antibody-mediated Rejection
Humoral Rejection


Volar Locked Plating Versus Bridging External Fixation

Summary: A randomized, prospective comparison of volar locked plating versus Hoffman II bridging external fixation supplemented by K-wire fixation in patients with comminuted distal radius fractures, AO/OTA type C2 & C3.~Hypothesis:~There is no significant difference in using volar plates compared to Hoffman II bridging external fixation supplemented by K-wire fixation in patients with comminuted distal radius fractures, AO/OTA type C2 & C3 as evaluated by a Quick-DASH score at 24 months follow-up.
Inclusion criteria: inclusion criteria:

 All patients admitted to Ahus and Lillestrom legevakt with a distal radius fracture are to be classified according to the system of the Orthopaedic Trauma Association (AO/OTA).

 All patients between the age of 18 and 70 diagnosed with a C2- or C3-type fracture, or a dislocated C1-fracture, are eligible for inclusion.

Exclusion criteria: :

 Gustillo-Anderson type III open fractures

 Previous distal radius/ulna-fracture and/or disabling hand injury of the same extremity

 Dementia

 Congenital anomaly

 Bilateral radius fracture

 Pathological fracture other than osteoporotic fracture

 Congenital bone disease (for example osteogenesis imperfecta)

 Age below 18 and above 70

 Disabling nury to other parts og the movement apparatus at the same time as the current injury


Unprepped CT Colonography

Summary: It is our objective to improve the performance of CTC in the prepared colon, and to validate CTC in the unprepared colon for the detection of colorectal neoplasia. The cost-effectiveness ratio of CTC in the unprepared colon will compare favorably with other colorectal screening test.
Inclusion criteria: inclusion criteria:

 Average risk or higher for colorectal cancer and scheduled for colonoscopy with any of the following indications:

 Prior colorectal cancer, prior colorectal adenoma, strong family history of colorectal neoplasia, iron deficiency.

 Age ≥ 40 -100 years

 Known or highly suspected primary colorectal neoplasms > 10 mm (n = 160)

 Higher than average risk for colorectal cancer and scheduled for colonoscopy with any of the following indications: prior colorectal cancer, prior colorectal adenoma, strong family history of colorectal neoplasia, iron deficiency.

Exclusion criteria: :

 Less than 1/2 of colorectum remaining

 Inflammatory bowel disease (Crohns, Chronic Ulcerative Colitis)

 Familial Polyposis

 Melena, hematochezia


A Phase I Study of Monoclonal Antibody TB-402 in Healthy Male Volunteers

Summary: Dose escalation study to assess the safety and tolerability of TB-402, a monoclonal antibody directed against FVIII, versus placebo in healthy male volunteers.
Inclusion criteria: inclusion criteria:

 Males 18 to 45 (Groups 1-9) or 55 to 75 (Group 10) years of age

 No clinically important abnormal physical, laboratory, ECG findings

 Normal (or abnormal but ncs) supine blood pressure (BP) and heart rate (HR)

Exclusion criteria: :

 Self or family history of cardiovascular or pulmonary disorder, coagulation or bleeding disorders or reasonable suspicion of vascular malformations eg cerebral haemorrhage, aneurysm or premature stroke.

 Any autoimmune disease.

 Previous allergic reaction to immunoglobulin.

 Present, or history of, severe allergy, for example asthma or anaphylactic reactions or allergy requiring treatment.

 Consumption of aspirin, other non-steroidal anti-inflammatory drugs or other drugs known to affect platelet function or any other aspect of coagulation within 14 days before drug administration.

 Abnormal platelet function or clinically significant out of range values for any coagulation tests.

 History of important bleeding episodes eg haematemesis, rectal bleeding, severe or recurrent epistaxis, haemoptysis, haematuria or intracranial haemorrhage.

 Screening FVIII:C < 50%.


Efficacy of Telemonitoring on CPAP Treatment Compliance in Obstructive Sleep Apnea (OSA) Patients

Summary: The purpose of this study is to compare the effectiveness of telemonitoring versus standard follow-up on CPAP treatment compliance in Obstructive Sleep Apnea Syndrome (OSAS).
Inclusion criteria: inclusion criteria:

 Men and Women over 18 years old

 Diagnosed as OSA and requiring CPAP treatment

 Written informed consent form signed.

Exclusion criteria: :

 Patients with impaired lung function (overlap syndrome, obesity hypoventilation syndrome, and restrictive disorders)

 Severe heart failure

 Severe chronic pathology associated

 Psychiatric disorder

 Periodic leg movements

 Pregnancy

 Other dyssomnias or parasomnias

 Patients already treated with CPAP


Relative Adrenal Insufficiency in Preterm Very Low Birth Weight Infants With Shock

Summary: The objective of this study is to estimate the prevalence of relative adrenal insufficiency in preterm very low birth weight infants with and without shock.
Inclusion criteria: inclusion criteria:

 All preterm (28 to 34 week gestation) very low birth weight (birth weight 750-1500grams.) infants born at AIIMS would be eligible for enrollment in the study. Of these infants, those who meet the following criteria would be enrolled.

 Cases: Preterm (28 to 34 week gestation) infants with birth weight between 750 and 1500 grams with shock in the first week of life requiring vasopressor therapy (dopamine or dobutamine or both in a dose of > 10 mcg/kg/min)

 Controls: Stable preterm (28 to 34 week gestation) infants with birth weight between 750 and 1500 grams who are matched for gestational age, birth weight, postnatal-age.

Exclusion criteria: :

 Major congenital malformations

 Mother receiving anticonvulsant / anti-tubercular drugs (rifampicin, isoniazid)

 Postnatal corticosteroid treatment

 Refusal to give consent


A Trial of Intermittent Treatment in the Prevention of Malaria in Senegalese Children

Summary: In countries of the Sahel and sub-Sahel, malaria transmission is highly seasonal with nearly all infections occurring during a few months of the year. However, mortality and morbidity from malaria may be high during this period, especially in young children who are the group most at risk.~Intermittent preventative treatment (IPT) is a new approach to the prevention of malaria in this situation. IPT involves the administration of an anti-malarial to children at risk for malaria at fixed times, even if they are not infected. To investigate how effective this approach might be in Senegal, a trial has been undertaken in which 1136 children aged 6 weeks to 59 months were given a single dose of sulfadoxine pyrimethamine and artesunate on three occasions during a three-month rainy season and the incidence of clinical malaria in these children was compared with that in a group of children who received placebo. Additional observations were made on the incidence of side effects in children in the two groups and on the impact of IPT in children (IPTc) on markers of drug resistance in children whose blood films were positive for Plasmodium falciparum.
Inclusion criteria: inclusion criteria:

 Ages 6 weeks to 59 months

 Residence in the study area

 Informed consent

Exclusion criteria: :

 Known allergy to study drugs

 Serious underlying illness


Effects of Sleep Duration on Eating and Activity Behaviors

Summary: The purpose of the proposed study is to determine whether the amount children sleep is associated with changes in hormones, hunger, motivation to eat, and food intake. Fifty children 8-11 years old who sleep 9-10 hours per night will be enrolled for a 3-week study. For 1 week each, children will be asked to sleep their typical amount, increase their sleep by 1-½ hours, and decrease their sleep by 1-½ hours. Half of the children will be asked to increase their sleep first and half to decrease their sleep first. During each week, the following will be gathered: sleep duration (measured by actigraphy, which is a small device that measures sleep), levels of hormones measured through blood draws, self-reported hunger and appetite, food intake (measured by 3 days of 24-hour recall), how motivated children are to eat (measured using a computer activity), and child height and weight. We believe that when children sleep less they will show changes in hormones associated with hunger and appetite, report being hungrier, be more motivated to eat, and eat more food.
Inclusion criteria: inclusion criteria:

 Age 8-11 years old

 BMI for age and gender > 5th percentile (but no greater than 100% overweight)

 Sleep approximately 9-10 hours nightly

 Attend elementary school

 Like at least 1 food and 1 activity used in the reinforcement paradigm

 Able to understand and complete the reinforcement paradigm

Exclusion criteria: :

 Existence of a diagnosable sleep disorder

 Medical or psychiatric condition that could influence sleep or weight

 Onset of menarche

 Inability to complete study materials, including diagnosed disabilities

 Dietary restrictions/allergies to foods used in the study that preclude them from study participation


Sofia Strep A FIA Field Study

Summary: The purpose of this study is to demonstrate the ability of the Sofia Strep A FIA test and Sofia Analyzer to accurately detect a throat swab specimen for the presence or absence of Group A Streptococcus when compared to culture.
Inclusion criteria: inclusion criteria:

 Presence of sore throat

 Redness of the posterior pharyngeal wall

 Tonsillar exudate

 Tonsillar swelling

 Tender anterior cervical adenopathy

 Fever, > 38º C (100.4ºF) at presentation or within past 24 hours

 Other symptoms that may be present, in addition to above symptoms for GAS:

 Rash, typical of scarlet fever

 Abnormal tympanic membranes

 Palatal petechiae

Exclusion criteria: :

 Subjects treated with antibiotics currently or within the previous week (7 days) are not to be included in this study.

 At clinical sites requiring informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.

['In Vitro Diagnositc aid for diagnosis']

['Group A Streptococcus', 'Strep Throat']


The Immune Tolerance Mechanism Induced by IL-17-producing Regulatory T Cells in the Orthotopic Liver Transplant Recipients With Aspergillosis

Summary: Infection accounted for the first cause of death in patients after liver transplantation, and 2 / 3 of the cause of death was fungal infections. The investigators group early found that T cell subsets playing a role of inducing immune tolerance were significantly increased in vivo of liver transplantation patients with aspergillus infection, which may be a kind of Treg cells expressing IL-17. To explore the immune tolerance mechanism induced by the immune balance cells is important to liver transplantation patients for improving efficacy and reducing the mortality. Therefore, the investigators are going to get the blood sample and liver tissue of the liver transplantation patients before and after treatment of aspergillus infection, flow cytometry analysis of blood T cell subsets, Cytometric Bead Array to detect changes in blood cytokines, laser capture microdissection to obtain liver biopsies of inflammatory cells in portal area and further for analysis of T cell subsets and protein. And the investigators are also to investigate the characteristics of CCR6 + CD4 + FOXP3 + Treg cell clones secreting IL-17 and the capacity of which suppressing conventional T cell proliferation. This study may find new methods, such as certain types of T cell subsets or cytokines for the treatment of liver transplant patients, which not only to anti-rejection but also to reduce fungal infection.
Inclusion criteria: inclusion criteria:

 Liver transplantation patients

Exclusion criteria: :

 Psychopath

['Liver Transplantation', 'Aspergillus', 'Interleukin-17', 'Treg Cell', 'Immune Tolerance']

Liver Transplantation
Aspergillus
Interleukin-17
Treg Cell
Immune Tolerance


Study of Tomotherapy in Patients With Benign Brain Tumour

Summary: Although malignant brain tumors are the most common type of primary brain tumor, there are a number of other benign brain tumors that exist. Many difficulties exist with treating these tumors that have led to controversies in the best treatment. A common issue among these brain tumors is the risk of long term side effects from treatment. What limits the use of curative radiation therapy is the ability to deliver a maximal dose to the tumor while minimizing the amount of radiation to the normal structures in the brain. A new method of delivering radiation, called tomotherapy, has been acquired at the Cross Cancer Institute (CCI) and will be used in this study. It has the ability to deliver a high dose of radiation to the tumor while minimizing the amount of radiation to normal brain structures. This study will use this method of radiation therapy to deliver radiation and see if the long term side effects from radiation therapy can be reduced.
Inclusion criteria: inclusion criteria:

 Histopathologically confirmed newly diagnosed base of skull benign tumour

 Karnofsky Performance Status (KPS) equal to or greater than 70

Exclusion criteria: :

 Brain metastases or recurrent tumour

 Prior radiotherapy (RT) to head or neck

 No prior chemotherapy or radiosensitizer


A Study to Evaluate Efficacy of YM060 on Diarrhea-predominant Irritable Bowel Syndrome (D-IBS) in Female Patients

Summary: A study to verify the superiority of YM060 (ramosetron) to placebo for female patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.
Inclusion criteria: inclusion criteria:

 Patients meeting the Rome III Diagnostic Criteria

 Loose (mushy) or watery stools within the last 3 months

 Abdominal discomfort and/or pain during their non-menstrual period

Exclusion criteria: :

 Patients with a history of surgical resection of the stomach, small intestine or large intestine

 Patients with a history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative)

 Patients with a history or current diagnosis of colitis ischemic

 Patients with a current diagnosis of enteritis infectious

 Patients with a current diagnosis of hyperthyroidism or hypothyroidism

 Patients who are currently participating in another clinical trial (including a post-marketing clinical study) or those who participated in another clinical trial (including a post-marketing clinical study) within 12 weeks before the study

 Patients with a history or current diagnosis of malignant tumor

 Patients with a history of abuse of drugs or alcohol within 1 year or those who are currently abusing them


Immune Responses After a Four-site Intradermal Rabies Booster Vaccination in HIV-infected Adults

Summary: A four-site intradermal rabies booster vaccination in HIV - infected patients who have ever received primary rabies vaccination could improve their immune response to this kind of vaccine.
Inclusion criteria: inclusion criteria:

 HIV infected patients

 Age 18 - 60 years

 Received primary rabies immunization

Exclusion criteria: :

 Have any active opportunistic infections

 Received blood or blood product within 3 months

 Allergy to vaccine or any vaccine components

 Received anti-malarial drugs


Effects of Nutritional Supplementation in Malnourished Patients in Stable COPD

Summary: Insufficient energy intake and systematic inflammation lead to malnutrition in patients with chronic obstructive pulmonary disease (COPD). Nutritional supplementation improves the patients'nutritional status by increasing energy intake and providing anti-inflammatory elements，which can relieve the patients' symptoms and delay the disease progression.
Inclusion criteria: inclusion criteria:

 Patients from Zhujiang Hospital affiliated from Southern Medical University

 Patients aged between 40 and 90 years old

 Patients gendered into male or female

 Patients with pulmonary function test of FEV1/FVC<70% and FEV1<80% predicted

 Patients presenting one or more of the following situations of malnutrition or nutritional risk: BMI <21 kg/m2 (or<23 kg/m2 in patients ≥ 65); unintentional weight loss >10% in the past 6 months; unintentional weight loss >5% in last month; FFMI <15 kg/m2 (women) or <16 kg/m2 (men)

 Patients able to answer question

 Patient able to eat and drink

 Patients who signed informed consent

Exclusion criteria: :

 Patients with signs of an airway infection

 Patients with malignant disorders

 Patients with recent surgery

 Patients with gastrointestinal ,cardiovascular diseases,neurological diseases or endocrine disease

 Patients with bullae lung

 patients treated with oral steroids or immunosuppressors

 Patients requiring other nutritional supplements or parenteral nutrition

 Patients suffering from acute exacerbation over the previous 4 weeks

 Patients with lack of motivation or poor compliance

['Chronic Obstructive Pulmonary Disease(COPD)', 'Malnutrition']


3-D Reconstruction of CT Scan Images in the Evaluation of Non-Specific Pulmonary Nodules

Summary: In recent years, more and more people are having lung CT scans performed to screen for various cancers. Many of them have small abnormalities detected, called nodules, which - for a variety of reasons - doctors are unable to biopsy. As a result, many patients have their CT scans repeated on a regular basis to see if their nodules grow. This process can last several years.~Many patients experience significant anxiety during this process, when they are aware of a spot in the lung, but are not told any specific cause.~Researchers at Memorial Sloan-Kettering have developed a new way to look at lung nodules in three dimensions. The purpose of this project is to see if any change in the nodules can be detected sooner by this method than by traditional CT scans.
Inclusion criteria: inclusion criteria:

 Referral to the pulmonary or thoracic surgery service for undiagnosed pulmonary nodules.

 History of smoking exceeding 10 pack-years (pack year defined as number of packs of cigarettes per day multiplied by the number of years smoked).

 Age >18

 Nodule size 5 to 15 mm in diameter.

Exclusion criteria: :

 Clinical indication for immediate biopsy via bronchoscopy, fine needle aspiration, or video-assisted thoracoscopic Surgery (VATS)

 Active lung cancer or metastasis to the lung.

 Contraindication to needle biopsy.

 Pneumonectomy

 Need for supplemental oxygen.

 Radiation pneumonitis

 Interstitial lung disease.

['Undiagnosed Pulmonary Nodules', 'Lung Nodules']

Undiagnosed Pulmonary Nodules
Lung Nodules


Effectiveness of Family-Focused Treatment Plus Pharmacotherapy for Bipolar Disorder in Adolescents

Summary: This study will evaluate the effectiveness of family-focused treatment (FFT) plus pharmacotherapy in treating adolescents with bipolar disorder.
Inclusion criteria: inclusion criteria:

 Between the ages of 13 years, 0 months and 17 years, 11 months

 Meets The Diagnostic and Statistical Manual of Mental Disorders - IV criteria for either of the following conditions: bipolar I or bipolar II disorder with a manic, mixed, or hypomanic episode within 3 months of study entry; or a depressed episode within 3 months of study entry with a prior history of a manic, hypomanic, or mixed episode (if the participant only meets criteria for a current hypomanic episode, there must also be a history of at least one prior depressive, manic, or mixed episode)

 Has experienced severe depression, hypomania, or mania symptoms for a period of at least 1 week within the 3 months prior to study entry

 Lives with at least one biological or step-parent who is available and willing to participate in treatment (parents not currently living with the adolescent participant may also participate)

Exclusion criteria: :

 Currently in full recovery (experienced minimal symptoms for at least 8 continuous weeks)

 Meets Diagnostic and Statistical Manual of Mental Disorders, IV criteria for substance abuse disorder or substance dependence disorder within 3 months of study entry (based on the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version )

 Meets current criteria for bipolar, not otherwise specified, or substance-induced mood disorder

 Diagnosis of mental retardation, autism, or organic central nervous system disorder

 Severe, unremitting psychosis that is unresponsive to neuroleptic medications, and has lasted more than 3 months

 Requires extended inpatient treatment (although participant can be hospitalized at the time of intake into the study)

 Current life-threatening eating disorder, neurological condition, or other medical problem that requires immediate treatment

 Exhibits or expresses serious homicidal tendencies

 Victim of current sexual or physical abuse by parents or is in an environment marked by domestic violence among the parents or step-parents

['Family-Focused Treatment Plus Pharmacotherapy', 'Enhanced Care Plus Pharmacotherapy']


Study to Assess Efficacy of Nicorandil+Atenolol vs Atenolol in Treatment of Chronic Stable Angina.

Summary: This study is to determine the anti-anginal and anti-ischemic effect of k-channel opener, nicorandil in patients of chronic stable angina.
Inclusion criteria: inclusion criteria:

 Patients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes.

 Male and female

 Age 25 to 65 years

 Patient must understand and be willing, able and likely to comply with all study procedures and restrictions and comprehends the diary cards.

 Patient must be able to give voluntary written informed consent.

Exclusion criteria: :

 Hypertension of > 170/100 mm of Hg

 Valvular heart disease and cardiomyopathy

 Myocardial infarction in < 6 months

 Unstable angina

 Congestive cardiac failure

 Severe anemia (Hb 7G/dl)

 Cardiac arrhythmias or II or III degree AV block

 Significant liver or renal dysfunction

 IDDM (Type-1 diabetes mellitus)

 Systolic blood pressure < 100 mm Hg

 Pregnant and nursing women

 Known hypersensitivity to nicorandil

 On calcium channel blockers

 Patients not eligible for Tc 99m SPECT

 Patients in whom beta blockers are contraindicated

 Geographical inaccessibility for treatment or follow-up evaluations


A Comparison of an Investigational Dressing to Tegaderm Matrix Wound Dressing in the Management of Diabetic Foot Ulcers

Summary: The primary objective is to:~Assess the effect of the Non-adherent study dressing to 3M Tegaderm Matrix Dressing with PHI technology on wound healing in patients with a diabetic foot ulcer.~Secondary objectives are to:~Assess the adverse events that occur in subjects randomized to the investigational dressing in comparison to subjects randomized to the Tegaderm Matrix Dressing with PHI technology.~Assess the costs of using the investigational dressing compared to the Tegaderm Matrix Dressing with PHI technology.~Assess and compare the impact that these dressings have on patients' quality of life.~Assess the wound's biological response and pH to the study dressings.
Inclusion criteria: inclusion criteria:

 Is the subject 18 years of age or older?

 Does the subject have a chronic full thickness diabetic foot ulcer (DFU) inferior to the malleolus that has been present for a minimum of four (4) weeks?

 Does the diabetic foot ulcer measure greater than 1.0 cm2 and less than 25.0 cm2 after the wound is debrided?

 Does the subject show evidence of neuropathy?

 Is the subject's wound free of tunneling and showing no exposed periosteum or bone and free of clinical infection defined as the presence of local signs and symptoms including purulence, warmth, tenderness, pain, induration, cellulitis, bullae, crepitus, abscess, fasciitis and osteomyelitis?

 Is the study wound able to be off loaded or achieve pressure relief and permit daily dressing changes?

 Is the subject willing to have three (3) wound biopsies taken (Visit 0, 4 and 8)?

 Is the subject willing to have photos taken of their wound and permit use of the photos in publications?

 Has the subject or their legally authorized representative signed an Institutional Review Board approved informed consent document and authorized the use and disclosure of protected health information?

 Does the subject have adequate circulation to the foot as evidenced by an Ankle Brachial Index (ABI) of 0.8 - 1.2; or if the ABI is greater than 1.2, does the subject show toe pressures >40 mmHg, or transcutaneous oximetry (TcPO2) > 40 mm Hg, or does the subject show adequate circulation on an arterial Doppler study? (ABI or Doppler results must be < 45 days old.)

 Is the subject able to comply with the protocol requirements?

 If the subject is a woman of child bearing potential is she practicing an acceptable form of birth control as determined by the Investigator, and is she willing to have a pregnancy test?

Exclusion criteria: :

 Is the subject pregnant or breast feeding or have they given birth within the 3 weeks preceding the screening visit?

 Has the subject been diagnosed with a malignant disease and received chemotherapy or treatment for a malignancy within the past 1 year?

 Does the subject have an infection requiring systemic antibiotic treatment?

 Has the subject ever received radiation therapy or other local therapy for malignancy at the extremity where the wound is located (from patient history)?

 Is the subject currently using systemic steroids, or have they used systemic steroids within the previous 2 weeks, or are they projected to require systemic steroid use during the study as evidenced by a history of chronic systemic steroid use? (Topical steroids (except on the study extremity) and steroid inhalants will be allowed in the study.)

 Does the subject have Lupus or Crohn's disease?

 Does the subject have an oxygen dependency?

 Has the subject received hyperbaric oxygen therapy within the previous 90 days?

 Has the subject had vascular surgery relating to the wound within 30 days prior to the Screening Visit?

 Does the subject have an active Charcot foot deformity of the foot presenting the ulcer?

 Has the subject received Dermagraft®, Apligraf, or any other biologically active wound care product, or used Regranex Gel®, KGF, TGFβ or another topical growth factor to the study ulcer within the 30 days prior to the Screening visit?

 Does the subject's wound require the use of topical silver, topical antibiotics, enzymatic debridement agents or other topical agents?

 Has the subject been enrolled in any investigational study within 30 days of the Screening Visit?

 Does the subject have any medical condition that in the opinion of the investigator should exclude him/her from participating in the study?

 Has the subject received ultrasonic debridement or electrical stimulation within 7 days of the Screening Visit?


Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)

Summary: A long-term study of current treatments for bipolar disorder, including medications and psychosocial therapies.
Inclusion criteria: General inclusion criteria:

 current age 15 or older (Best Practice Pathway) or 18 years or older (Randomized Care Pathways);

 able to give informed consent for data to be harvested;

 meet DSM-IV criteria for Bipolar I Disorder, Bipolar II Disorder, Bipolar Disorder NOS, or Cyclothymic Disorder;

 undergo a complete standard evaluation including clinical interview, self ratings, and laboratory studies;

 meet with Clinical Specialist as scheduled;

 able to complete all Study Registry Forms within 3 months of registration.

 General
Exclusion criteria: :

 unwilling or unable to adhere to basic study requirements (i.e., complete rating forms, or attend scheduled evaluations);

 not competent to give informed consent in the opinion of the investigator (e.g., psychotic).

 Participants will be asked to remain in the study for up to five years so that the investigators can document and evaluate long-term treatment outcome. Participants will meet with their STEP-BD psychiatrist for periodic evaluations and/or treatment adjustments during the course of the study, fill out various self-rating forms, and when applicable, participate in psychotherapy. One of the psychotherapy options, Family-Focused Therapy, will require participants and their families to attend counseling sessions together. Overall, the estimated amount of time required from participants in the study is 2 to 4 hours per month.

['lithium', 'valproate', 'bupropion', 'paroxetine', 'lamotrigine', 'risperidone', 'inositol', 'tranylcypromine', 'Cognitive Behavioral Therapy', 'Family-focused Therapy', 'Interpersonal and Social Rhythms Therapy']


Amlodipine vs Nitrates Study in Patients With Chronic Stable Angina

Summary: The objective of study is to compare the anti-ischemic efficacy and safety profiles of once daily amlodipine or isosorbide-5-mononitrate in the treatment of stable asymptomatic and symptomatic myocardial ischemia
Inclusion criteria: inclusion criteria:

 Outpatients > =18 years of age with diagnosed clinically stable angina pectoris

Exclusion criteria: :

 Patients with congestive heart failure, clinically significant cardiovascular disease, standing systolic blood pressure of less than 100mmHg, concomitant anti-anginal therapies similar to sublingual NTG

['Amlodipine', 'iso- 5 - mononitrate', 'Blood tests', 'Exercise Stress Test']

Amlodipine
iso- 5 - mononitrate
Blood tests
Exercise Stress Test


A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Mild Type of Hand, Foot, and Mouth Disease

Summary: The study is aimed to evaluate the effectiveness and safety of traditional Chinese medicine (TCM) for treatment of hand, foot, and mouth disease (HFMD).
Inclusion criteria: inclusion criteria:

 Clinical diagnosis of severe hand-foot-mouth disease patients according to Hand-Foot-Mouth Disease Treatment Guidelines 2010 issued by China's Ministry of Health; More than 1/3 patients should be diagnosed by etiological examination.

 Less than 48 hours of occurrence of fever and/or occurrence of tetter or herpes.

 Age of 1-14 years.

 Patients or their guardians agree to participate in this study and signed the informed consent form.

Exclusion criteria: :

 Complicated with other serious primary diseases in organ such as congenital heart disease, chronic hepatitis, nephritis and blood diseases, etc.

 With history of allergies on traditional Chinese medicine.

 Patients or their guardians suffering from Psychiatric diseases.

 Attending other clinical studies on HFMD after diagnosed.

['Western therapy', 'TCM Syndrome Differentiation and Treatment', 'Western therapy plus TCM treatment']


Prehospital Tranexamic Acid Use for Traumatic Brain Injury

Summary: Primary aim: To determine the efficacy of two dosing regimens of TXA initiated in the prehospital setting in patients with moderate to severe TBI (GCS score ≤12).~Primary hypothesis: The null hypothesis is that random assignment to prehospital administration of TXA in patients with moderate to severe TBI will not change the proportion of patients with a favorable long-term neurologic outcome compared to random assignment to placebo, based on the GOS-E at 6 months.~Secondary aims: To determine differences between TXA and placebo in the following outcomes for patients with moderate to severe TBI treated in the prehospital setting with 2 dosing regimens of TXA:~Clinical outcomes: ICH progression, Marshall and Rotterdam CT classification scores, DRS at discharge and 6 months, GOS-E at discharge, 28-day survival, frequency of neurosurgical interventions, and ventilator-free, ICU-free, and hospital-free days.~Safety outcomes: Development of seizures, cerebral ischemic events, myocardial infarction, deep venous thrombosis, and pulmonary thromboembolism.~Mechanistic outcomes: Alterations in fibrinolysis based on fibrinolytic pathway mediators and degree of clot lysis based on TEG.~Inclusion: Blunt and penetrating traumatic mechanism consistent with TBI with prehospital GCS ≤ 12 prior to administration of sedative and/or paralytic agents, prehospital SBP ≥ 90 mmHg, prehospital intravenous (IV) access, age ≥ 15yrs (or weight ≥ 50kg if age is unknown), EMS transport destination based on standard local practices determined to be a participating trauma center.~Exclusion: Prehospital GCS=3 with no reactive pupil, estimated time from injury to start of study drug bolus dose >2 hours, unknown time of injury, clinical suspicion by EMS of seizure activity, acute MI or stroke or known history, to the extent possible, of seizures, thromboembolic disorders or renal dialysis, CPR by EMS prior to randomization, burns > 20% TBSA, suspected or known prisoners, suspected or known pregnancy, prehospital TXA or other pro-coagulant drug given prior to randomization, subjects who have activated the opt-out process when required by the local regulatory board.~A multi-center double-blind randomized controlled trial with 3 treatment arms:~Bolus/maintenance: 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.~Bolus only: 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.~Placebo: Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.
Inclusion criteria: inclusion criteria:

 Blunt or penetrating traumatic mechanism consistent with traumatic brain injury

 Prehospital Glasgow Coma Score (GCS) score ≤ 12 at any time prior to randomization and administration of sedative and/or paralytic agents

 Prehospital systolic blood pressure (SBP) ≥ 90 mmHg prior to randomization

 Prehospital intravenous (IV) or intraosseous (IO) access

 Estimated Age ≥ 15 (or estimated weight > 50 kg if age is unknown)

 Emergency Medicine System (EMS) transport to a participating trauma center

Exclusion criteria: :

 Prehospital GCS=3 with no reactive pupil

 Estimated time from injury to hospital arrival > 2 hours

 Unknown time of injury - no known reference times to support estimation

 Clinical suspicion by EMS of seizure activity or known history of seizures, acute myocardial infarction (MI) or stroke

 Cardio-pulmonary resuscitation (CPR) by EMS prior to randomization

 Burns > 20% total body surface area (TBSA)

 Suspected or known prisoners

 Suspected or known pregnancy

 Prehospital TXA given prior to randomization

 Subjects who have activated the opt-out process when required by the local regulatory board

['1 gram Tranexamic Acid (TXA)', '2 grams TXA', '0.9% Sodium Chloride injectable']

1 gram Tranexamic Acid (TXA)
2 grams TXA
0.9% Sodium Chloride injectable


Progesterone Suppression of Nocturnal LH Increases in Pubertal Girls

Summary: The purpose of this study is to learn more about how gonadotropin-releasing hormone (GnRH) and luteinizing hormone (LH) pulses are controlled during puberty. In this study, the investigators aim to discover whether or not giving 2 small doses of progesterone to early pubertal girls will prevent the nighttime increase of GnRH and LH pulses. From the information gathered in this study, the investigators may be able to learn more about how menstrual cycles are normally established in girls during puberty. Ultimately, if these normal processes can be understood, the investigators may be able to better understand abnormalities of puberty.
Inclusion criteria: inclusion criteria:

 Female volunteers in early to mid-puberty (i.e. late Tanner 1 [estradiol level >20 pg/ml], Tanner 2, or Tanner 3)

 Premenarcheal

Exclusion criteria: :

 BMI-for-age > 85th percentile or < 5th percentile

 Pregnancy

 Inability to comprehend what will be done during the study or why it will done

 Hyperandrogenism (e.g., hirsutism, elevated free testosterone level)

 History of allergy to progesterone (which is extremely rare)

 Hemoglobin less than 12 g/dl and hematocrit less than 36%

 Persistently abnormal sodium, potassium, or bicarbonate (i.e. confirmed on repeat)

 Persistently elevated creatinine, hepatic transaminases, or alkaline phosphatase (i.e., confirmed on repeat)

 Total bilirubin > 1.5 times upper limit of normal (i.e. confirmed on repeat)

 Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure; asthma requiring intermittent systemic corticosteroids; etc.)

 Untreated hypo- or hyperthyroidism, reflected by persistently abnormal thyroid-stimulating hormone (TSH) values

 Premature adrenarche (i.e., occurring before age 8 y)

 Basal (follicular) 17-hydroxyprogesterone > 200 ng/ml (confirmed on repeat)

 Dehydroepiandrosterone-sulfate (DHEA-S) > age-appropriate upper limit of normal (confirmed on repeat)

 Hyperprolactinemia (confirmed on repeat)

 Weight less than 25 kg


Long-term Pleiotropic Effect of Statins in Patients With Peripheral Arterial Disease

Summary: The purpose of this study is to determine the long-term effects of statins, atorvastatin, upon Nitric Oxide, as an endothelial function assessment, and C-Reactive Protein, an inflammatory marker, levels in patients with Peripheral Arterial Disease. These long-term biological pleiotropic effects of statins will offer information on the role of endothelial function and systemic inflammation in the etiopathogenesis of PAD.
Inclusion criteria: inclusion criteria:

 patients at the time of diagnosis of Fontaine grade II peripheral arterial disease (PAD), confirmed by hemodynamic evaluation (Doppler ultrasound)

 over 18 years old

Exclusion criteria: :

 patients had previously undergone revascularization

 patients were receiving treatment with statins

 patients with contraindications to statin use.

 patients with coexistence of chronic inflammatory diseases or steroidal medication

['Atorvastatin', 'Standard Medical Treatment']


Brief Alcohol Intervention to Reduce At-Risk Drinking Among Type 2 Diabetics

Summary: This study is designed to test an intervention to reduce at-risk drinking among Type 2 diabetic patients. At-risk drinking is associated with inferior diabetes treatment adherence and control. The investigators hypothesize that our brief alcohol intervention will result in a reduction in drinking and better diabetes treatment adherence and control. If successful, this intervention could help diabetics to gain better control of their diabetes and live healthier lives.
Inclusion criteria: inclusion criteria:

 18 years or older,

 have Type 2 diabetes,

 report at-risk drinking in past month,

 report poor diabetes treatment adherence.

Exclusion criteria: :

 current alcohol dependence or current psychoactive substance abuse or dependence (excluding nicotine),

 currently psychotic,

 unable to provide the name and contact information for a significant other to corroborate self-report,

 unable to provide the name and contact information for two people who could serve as locators, do not have access to a telephone.

['Brief alcohol intervention', 'General health education']

Brief alcohol intervention
General health education


Surgical Lavage vs Serial Needle Aspiration for Infected Joints

Summary: Joint spaces are aseptic areas, meaning that they do not contain microorganisms. Any injury to the joint space could cause the entry of microorganisms, with the potential to cause infection. Septic arthritis refers to the infection of a joint space with microorganisms, usually bacteria. This invasion initiates a process of inflammation and causes irreversible damage to a joint cavity. Patients typically present with pain, swelling, decreased motion, and inability to use the joint. When bacteria enter a joint space, the host immune system responds by concentrating inflammatory cells within the joint. While inflammatory cells serve to eliminate the bacteria, they also produce substances that not only attack bacteria but also could destroy the joint space. These substances are called enzymes, and they could damage the cartilage (translucent fairly elastic tissue around the joint) and adjacent bone in the process. Because cartilage has a poor ability to cure itself, this process may lead to irreversible damage and chronic joint dysfunction. Studies have found that signs of early joint damage can be found within hours following joint infection. This is true even if antibiotic therapy (medicine to fight the infection) is started within 24 hours of infection. Also, delay in treatment has been related to poor outcome. However, the best method of treating septic arthritis has yet to be determined. Currently, there are two accepted ways for treating septic arthritis: serial needle aspiration (introducing a needle in the joint to aspirate the inflammatory liquid), and surgical lavage (opening and cleaning the joint space in the OR under anesthesia). Antibiotics are also used with these two forms of treatment. Supporters of surgery believe that the most dependable method of eliminating bacteria from a joint space is through arthrotomy (opening the joint with a surgical incision) and lavage (irrigation of the joint with copious saline solution) .Promoters of serial needle aspiration support this method because it is quick, does not require opening the joint space, and can be performed without anesthesia.At present, there are no conclusive studies comparing the two techniques. Hopefully, this study will help delineate the best course of management.
Inclusion criteria: inclusion criteria:

 Patients with acute onset of symptoms of less than or equal to two weeks' duration.

 Patients with infection of only the following joints: ankle, knee, hip, wrist, elbow, or shoulder

 Patients with proven bacterial infection by positive gram stain or culture of synovial fluid and with white blood cell count in synovial flood consistent with infection (75,000 - 150,000 cells/mm3.)

 Cases with negative synovial fluid cultures if positive blood cultures are present and associated with typical inflammatory synovial fluid changes without other identifiable sources of infection and if antibiotic therapy had been initiated earlier to explain negative synovial fluid cultures.

 Monoarticular arthritis

Exclusion criteria: :

 Gonococcal infections

 Infected prosthetic joints

 Adjacent osteomyelitis preceding joint infection

 Septic arthritis occurring as an incidental event late in the course of otherwise fatal illness

 Patients that are 17 years old or less.

 Polyarticular arthritis.

['Surgical Lavage (Arthrotomy)', 'Arthrocentesis (Serial needle aspiration)']


Study to Investigate the Seropersistence of TBE Virus Antibodies Approx. 3 Years After a Booster Vaccination With FSME-IMMUN 0.25 mL JUNIOR in Children

Summary: The objective of this study is to assess the TBE antibody persistence approximately three years after administration of a TBE booster vaccination with FSME-IMMUN 0.25 ml Junior in children who received either 0.25 mL or 0.5 mL TicoVac for their primary vaccination series in Study 146A.
Inclusion criteria: inclusion criteria:

 Male and female children who participated in Study 146A if:

 they and/or their parents/legal guardians understand the nature of the study and agree to its provisions

 written informed consent is available from the child (according to age and capacity of understanding) and the parents/legal guardians

 they received the complete 3-immunization primary vaccination series with either 0.5 ml or 0.25 ml TicoVac in Study 146A

 they received FSME-IMMUN 0.25 ml Junior for their first booster vaccination approximately 3 to 4 years after their third vaccination in Study IMAG-146A

Exclusion criteria: :

 Subjects who received any further TBE vaccination since their first TBE booster vaccination

 Subjects with a history of infection with, or vaccination against, other flaviviruses (e.g. dengue fever, yellow fever and/or japanese B encephalitis virus) since their third vaccination in Study 146A

 Subjects who have suffered from a disease (e.g. autoimmune disease) or have undergone a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions within 30 days before and after their first TBE booster vaccination

 Subjects who have been known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination in Study 146A

 Subjects who have received a blood transfusion or immunoglobulins within 30 days of study entry

['Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl']


The Effect of Allergen Immunotherapy on Exhaled Nitric Oxide in Adult Patients With Asthma and Allergic Rhinitis

Summary: This study will evaluate whether exhaled nitric oxide levels are affected by allergen immunotherapy (allergy shots). The investigators' hypothesis is that successful allergen immunotherapy may be accompanied by decreased exhaled nitric oxide levels.
Inclusion criteria: inclusion criteria:

 Subjects over 18 years old with allergic asthma and/or allergic rhinitis who are beginning allergen desensitization

Exclusion criteria: :

 Smokers

 Subjects of dimished capacity

['Allergic Asthma', 'Allergic Rhinitis']

:

 Smokers

 Subjects of dimished capacity


An Open-label, Randomized, and Comparative Study to Evaluate the Efficacy and Safety of Cefoperazone/Sulbactam in Comparison to Cefepime for the Treatment of Hospital-acquired Pneumonia and Healthcare-associated Pneumonia

Summary: This is a phase III, multi-center, open-label, comparative and randomized study in evaluating the efficacy and safety of cefoperazone/sulbactam versus cefepime for the treatment of hospital-acquired pneumonia and healthcare-associated pneumonia. The investigator will determine the total duration of study therapy, as clinically indicated. The minimum duration of study therapy will be 7 days and the maximum allowable duration of study therapy will be 21 days.
Inclusion criteria: inclusion criteria:

 Male or female patients aged ≧18 years old

 Patients with nosocomial bacterial pneumonia at least 48 hours after hospitalization or patients with healthcare-associated pneumonia(HCAP*).

 Clinical findings

 At least two of the following signs:

 Cough

 Fever: axillary temperature > 37.5℃ or tympanic temperature > 38.5℃

 Hypothermia: axillary temperature < 34℃ or tympanic temperature < 35℃

 Purulent sputum production or respiratory secretion

 Total peripheral white blood cell (WBC) count > 10,000/mm3; or > 15% band forms, regardless of total peripheral white count; or leucopenia with total WBC < 4500/mm3

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

 Hypoxemia (defined as a partial O2 pressure <60 mmHg while the patient was breathing normal air or a decrease in the partial O2 pressure of ≧25% from an initial value)

 Radiographic findings The chest radiograph should show the presence of a new or progressive infiltration on the chest X-ray film

 Microbiologic criteria If sputum specimen is available and collected, both tests are mandatory with at least one of the following results is positive:

 (1) Within 24 hours prior to, or at the time of enrollment, all patients should have had a culture and susceptibility testing of respiratory secretions or sputum to study drugs (2)Gram stain of respiratory secretions or sputum

 Patient must be able to sign a written informed consent form prior to the start of the study procedures. If any patient is unable to give consent, it must be obtained from the patient's legal representative

 Subject has not received more than 24 hours of a parenteral antibacterial drug for the current pneumonia. If subject has received more than 24 hours of a parenteral antibacterial drug, he/she must be declared as treatment failure.

Exclusion criteria: :

 Woman who are pregnant (determined by urine test) or lactating state

 Patients with known bronchial obstruction or a history of postobstructive pneumonia. (This does not exclude patients who have chronic obstructive pulmonary disease)

 A neutrophil count <1000/mm3

 Patients with pneumonia due to viral, fungal, or mycobacterial infection.

 Patients who were known to have been infected with human immunodeficiency virus

 Documented Legionella pneumonia

 Patients were infected with gram negative (G-) microorganism known to be resistant to one of the study antibiotics during trial

 Subjects with sputum gram stain of PMN>25, epithelial cell <10, and gram positive (G+) cocci in cluster predominant and phagocytosis

 Patients who have received any other investigational drug within 30 days prior to enrollment

 Patients who have received medications like cefoperazone, cefoperazone/sulbactam and cefepime within 30 days prior to enrollment

 Patients with abnormal pre-therapy laboratory data: aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≧ 3X ULN (upper limit of normal); or serum creatinine, urea nitrogen > 3X ULN

 A history of hypersensitivity to penicillins, cephalosporins, carbapenems or J-lactam/J-lactamase inhibitors

 Severe disease (eg. septic shock, acute respiratory distress syndrome, and multiple organ failure) which may limit survival during therapy and follow-up period, or confound the results of the study as judged by the investigator


Immunogenicity and Safety of AdimFlu-S, Formulation 2010-2011, in Infants Aged Between 6-12months Old

Summary: The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the seasonal flu vaccine(AdimFlu-S), as measured by hemagglutination inhibition (HAI) at 4 weeks after two doses of study vaccine, 4 weeks apart, in infants between 6 and 12 months of age.
Inclusion criteria: inclusion criteria:

 Boys or girls and aged >= 6 months old to <= 12 months old on the day of first vaccination;

 Subject's parent(s) or legal guardian(s) must be willing to comply with planned study procedures and be available for all study visits;

 Subject must be in good physical health on the basis of medical history, physical examination;

 Subject's parent(s) or legal guardian(s) must read and signed the study-specific informed consent prior to initiation of any study procedure.

Exclusion criteria: :

 Subjects had received influenza vaccine;

 History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;

 Personal or family history of Guillain- Barre' Syndrome;

 An acute febrile illness within 1 week prior to vaccination;

 Current upper respiratory illness (URI), including the common cold or nasal congestion within 72 hours;

 Subjects with influenza-like illness as defined by the presence of fever (temperature >= 38'C) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;

 Immunodeficiency, immunosuppressive or significant chronic illness not suitable for inactivated influenza vaccination;

 History of wheezing or bronchodilator use within 3 months prior to study vaccine;

 Receipt of live virus vaccine within 1 month prior to study vaccine or expected receipt vaccination before the last blood sampling for immunogenicity evaluation;

 Receipt of any inactivated vaccine within 2 weeks prior to study vaccination or expected receipt vaccination before the last blood sampling for immunogenicity evaluation;

 Receipt of any blood products, including immunoglobulin in the prior 3 months;

 Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine.


The Effects of Ginseng on Cancer-Related Fatigue

Summary: The goal of this clinical research study is to learn if panax ginseng (commonly called ginseng) can help to control fatigue and other symptoms such as depression, anxiety, and mood changes in patients with cancer. The safety of ginseng will also be studied.
Inclusion criteria: inclusion criteria:

 All patients with a histological diagnosis of cancer.

 Rate fatigue on a numerical scale during the previous 24 hours as >/= 4 on a 0 to 10 scale (0 = no fatigue and 10 = worst possible fatigue).

 Describe fatigue as being present every day for most of the day for a minimum of 2 weeks.

 Memorial delirium assessment scale </= 13.

 Are 18 years or older.

 Hemoglobin level of >/=8 g/dL within 2 weeks of enrollment. If the patient has not had blood drawn for a hemoglobin level in the previous two weeks, one will be performed to determine eligibility. Patients with a hemoglobin level <9g/dL will be evaluated for treatment of anemia.

 Able to understand and sign the informed consent.

 No concurrent use of chronic systemic steroids (defined as currently on more than 1 week of treatment).

 Controlled pain and depression symptoms, if present ( defined as no change in the Morphine equivalent dose of 30% or change in the dose of antidepressant medication in the past 2 weeks)

 Patients should have a Zubrod </= 2.

 All patients who are receiving chemotherapy and/or radiation therapy are eligible for study if they have completed at least one cycle of chemotherapy or targeted therapy, or > 1 week of radiation therapy, and if they have been approved to go on study by their primary oncologist. The PI/designated research staff of this study will obtain and document approval from the primary oncologist and principal investigator of the clinical trial in case the patient is on another clinical trial as referenced in the patient's study documents.

 Negative pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and a history of menses within the last 12 months. Pregnancy test to be performed no greater than 14 days prior to consent in study. In cases of women with elevated b-HCG, these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy. Women of childbearing potential need to be on or use contraception, or be abstinent during the study period. Their male partners must also use contraception (condom) or maintain abstinence. Birth controls specifications: Women who are able to become pregnant must use birth control during the study and for 30 days after the last ginseng/placebo dose. Acceptable forms of birth control include barrier methods (such as condom or diaphragm) with spermicide.

Exclusion criteria: :

 Major contraindication to ginseng: allergy/hypersensitivity to Panax species or their constituents (history of arrhythmias, agitation, or motor tics, or severe angina pectoris).

 Currently taking ginseng, methylphenidate or modafinil or have taken it within the previous 10 days.

 Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study.

 Currently with a diagnosis of major depression, manic depressive disorder, obsessive-compulsive disorder, or schizophrenia).

 Symptomatic tachycardia and uncontrolled hypertension (determined to be clinically significant by the PI).

 Currently receiving phenobarbital, diphenylhydantoin, primidone, phenylbutazone, MAOIs, clonidine and tricyclic antidepressant drugs

 Uncontrolled diabetes mellitus as defined by a random blood sugar of >200mg/dl not being monitored by their primary care physician.

 No concurrent full dose anticoagulant therapy. </= 1 mg/day of coumadin for preventing catheter clots allowed.

 History of hepatitis A, B and C.

 Women who are nursing.

['Panax Ginseng', 'Placebo', 'Questionnaires']


Tenecteplase Pulmonary Embolism Italian Study

Summary: To assess the efficacy and safety of Tenecteplase versus Placebo in normotensive patients with sub-massive Pulmonary Embolism and Right Ventricular Dysfunction (RVD) all receiving unfractionated heparin (UFH)
Inclusion criteria: inclusion criteria:

 age between 18 and 85;

 symptomatic PE confirmed by: high probability lung scan, or intermediate probability lung scan and objectively confirmed deep vein thrombosis, or spiral CT-scan or pulmonary angiography or TE echocardiography;

 normal blood pressure (SBP >100mmHg);

 RVD at echocardiography (see criteria);

 written informed consent.

Exclusion criteria: :

 absence of RVD at echocardiography;

 shock or hypotension (SBP < 100 mmHg);

 therapeutic heparin (UFH or LMWH) treatment for more than 48 hours prior to randomization;

 administration of thrombolytic agents within the previous 4 days;

 vena cava filter insertion or pulmonary thrombectomy within the previous 4 days

 chronic pulmonary hypertension or severe COPD;

 hypertension defined as blood pressure >180/110 mm Hg (systolic BP >180 mm Hg and/or diastolic BP >110 mm Hg) on a single, reliable measurement during current admission at enrolling site prior to randomisation;

 use of GP IIb/IIIa antagonists within the preceding 7 days;

 significant bleeding disorders either at present or within the past 6 months;

 active peptic ulceration;

 known diabetic haemorrhagic retinopathy or other haemorrhagic ophthalmic conditions;

 known haemorrhagic diathesis;

 known arterial aneurysm and known arterial/venous malformation;

 known neoplasm with increased bleeding risk;

 prolonged cardiopulmonary resuscitation (>10 minutes) in the previous two weeks;

 current oral anticoagulation;

 major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months;

 any known history of stroke or transient ischaemic attack (TIA) or dementia;

 any recent head trauma and any other trauma occurring after onset of the current pulmonary embolism;

 any known history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery);

 known subacute bacterial endocarditis;

 known acute pancreatitis;

 known severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension

 (oesophageal varices) and active hepatitis;

 pregnancy or lactation or parturition within the previous 30 days;

 women of childbearing potential must have a negative pregnancy test, or use a medically accepted method of birth control;

 treatment with an investigational drug under another study protocol in the past 7 days;

 previous enrolment in this study;

 known hypersensitivity to Tenecteplase, Alteplase, unfractionated heparin, or to any of the excipients;

 anticipated or obvious problem with vascular access;

 any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated;

 inability to follow protocol requirements


Accuracy of Multi-organ Ultrasound for the Diagnosis of Pulmonary Embolism

Summary: Patients with suspected Pulmonary Embolism (PE) and a high clinical probability or a high D-dimer level should undergo a second level diagnostic test such as Multidetector Computed Tomography Angiography (MCTPA). Unfortunately MCTPA involves radiation exposure, is expensive, is not feasible in unstable patients and has contraindications. UltraSound (US) is safe and rapidly available even in unstable patients. Many authors evaluated the diagnostic role of Compression Ultrasound Scan (CUS) for detecting limbs Deep Vein Thrombosis (DVT), TransThoracic Echocardiography (TTE) for detecting Right Ventricular Dysfunction (RVD) or Thoracic UltraSound (TUS) for detecting subpleural infarcts in patients with suspected PE. No previous studies have investigated the diagnostic accuracy of CUS, TTE and TUS combined (multiorgan US) for the diagnosis of PE. This study evaluates the diagnostic accuracy of multiorgan US.~Methods. Consecutive patients that underwent MCTPA in the Emergency Department for clinical suspicion of PE and with a simplified Well's score>4 (PE likely) or with a D-dimer value ≥500ng/ml were enrolled in the study. MCTPA was considered the gold standard for PE diagnosis. A multiorgan US was performed by an emergency physician sonographer before MCTPA. PE was considered echographically present if CUS was positive for DVT or TTE was positive for RVD or at least one pulmonary subpleural infarct was detected with TUS. The accuracy of the single and multiorgan US was calculated.
Inclusion criteria: inclusion criteria:

 Patients with clinical suspected pulmonary embolism

 Simplified Well's score>4 (PE likely) or D-dimer value ≥500ng/ml

 Patients that undergo MCTPA in the Emergency Department for suspected pulmonary embolism

Exclusion criteria: :

 Refused consent

 Less than 18 years old

 Not possible to perform ultrasound scan within 3 hours before MCTPA