LAA Excision With AF Ablation Versus Oral Anticoagulants for Secondary Prevention of Stroke

Summary: This cohort study aims to evaluate thoracoscopic left atrial appendage excision plus atrial fibrillation ablation versus oral anticoagulants for the prevention of stroke and non-central nervous systemic embolism in patients with atrial fibrillation and thromboembolism.
Inclusion criteria: inclusion criteria:

 18-80 years

 Have documented AF episodes

 The occurrence of ischemic stroke, TIA or systemic thromboembolism at least one month before enrollment

 Capable of understanding and signing the CRF

Exclusion criteria: :

 Reversible AF

 Modified Rankin score ≥4

 Having a history of rheumatic, severe valvular heart disease or heart valve replacement

 Having symptomatic carotid artery disease

 Having another disease which requires lifelong warfarin therapy

 Medical conditions limiting expected survival to <1 year

 Women of childbearing potential (unless post-menopausal or surgically sterile)

 Participation in any other clinical mortality trial

 Unable to give informed consent

['Thoracoscopic LAA Excision plus AF Ablation', 'Warfarin or Novel Oral Anticoagulants']

['Atrial Fibrillation', 'Stroke', 'Systemic Embolism']

Atrial Fibrillation
Stroke
Systemic Embolism


Clinical Registry of Patients Under Treatment With Atypical Antipsychotics

Summary: Antipsychotic drugs are characterized by blocking dopaminergic D2 receptors. They have been found to be effective and safe for the treatment of schizophrenia, bipolar disorders, depressive episodes associated with bipolar disorder, or psychotic symptoms in the context of Parkinson's disease. Atypical antipsychotics have lower blocking potency on D2 receptors, at the time that interact with serotoninergic, adrenergic and histaminergic receptors, among others. Quetiapine extended-release has the same clinical efficacy as the immediate-release formulation, but reduces the amount of daily doses, possibly contributing to increased treatment adherence.~The purpose of this registry is to explore adherence to treatment, the occurrence of adverse drug reactions and the clinical outcomes in a sample of patients under treatment with atypical antipsychotics in several Central American countries. For this study, clinical data will be extracted from the medical records of 1000 patients with schizophrenia, depressive disorders or Parkinson's Disease with hallucinations. Occurrence of adverse drug reactions, namely weight gain, somnolence, extrapyramidal reactions and symptoms of orthostatic hypotension; adherence to treatment; and changes in quality of life and clinical status will be assessed during the first 8 weeks of treatment.
Inclusion criteria: inclusion criteria:

 at least 18 years-old

 have a diagnosis of schizophrenia, major depressive disorder, bipolar depressive disorder, parkinson's disease with hallucination

 such patients should receive antipsychotics as their usual treatment

 they should give informed consent before participating

Exclusion criteria: :

 no treatment with atypical antypsichotics

 other diseases

['Schizophrenia', 'Major Depressive Disorder', 'Bipolar Depressive Disorder', "Parkinson's Disease With Hallucinations"]

Schizophrenia
Major Depressive Disorder
Bipolar Depressive Disorder
Parkinson's Disease With Hallucinations


Correlation of Location of Abdominal Tenderness With Acute CT Abnormalities in Emergency Department Patients

Summary: To determine the correlation between the region of abdominal tenderness determined by the examining physician and the location of acute pathology diagnosed on abdominal CT. We hypothesize that the acute pathology diagnosed by CT will lie within the region marked on the abdominal wall by the examining physician prior to CT.
Inclusion criteria: inclusion criteria:

 All consecutive emergency department patients undergoing abdominal CT for non-traumatic abdominal pain and tenderness will be prospectively enrolled, with the following exceptions. For study purposes, abdominal pain and tenderness is defined as pain and tenderness to direct palpation in the region anterior to the mid-axillary line bilaterally, and extending from the costal margins to the inguinal ligaments. Consequently, patients undergoing CT for indications such as isolated vomiting, fever without source, staging of malignancies, isolated flank pain or suspected renal colic, or other indications that do not meet the above definition will not be enrolled.

Exclusion criteria: :

 Pregnant women do not routinely undergo abdominal CT due to radiation concerns and will be excluded from the study.

 Patients with altered mental status or altered abdominal sensation (due to neurological conditions such as paraplegia) that may prevent assessment of the location of abdominal tenderness will be excluded.

 Preverbal children will be excluded as they rarely undergo CT and will be unable to indicate the region of maximal tenderness.


Unusual Clinical Findings of Herpes Esophagitis

Summary: Herpes esophagitis presents a clinical diagnostic challenge. The investigators report the first case of herpes esophagitis presenting as vocal fold palsy in an immunocompetent host. The investigators case highlights the importance of performing a detailed laryngoscopic examination in any patient with prolonged husky voice.
Inclusion criteria: inclusion criteria:

 Patient of Herpes esophagitis with vocal palsy presentation

Exclusion criteria: :

 Patient of Herpes esophagitis without vocal palsy presentation

['Herpes Esophagitis', 'Vocal Fold Palsy']


Community Awareness, Resources and Education (CARE I): Project 3

Summary: Community Awareness, Resources and Education (CARE) Project - Project 3 will determine if Appalachian women have unique risk factors for an abnormal Pap smear that might contribute to the increased risk of cervical abnormalities, specifically cancer, in their communities.
Inclusion criteria: inclusion criteria:

 Female

 18 years or older

 Able to give informed consent

 Intact cervix

 No prior history of invasive cervical cancer

 English speaking

 Willing to have biological specimens stored for future studies

 Resident of Appalachian Ohio

Exclusion criteria: :

 Pregnant

 Medical or psychiatric illness that precludes research project requirements, ability to give informed consent, or protocol compliance.

 Smokers (will be contacted by study team to see if they are eligible/willing to participate in CARE: Project 2


Magnetic Resonance Imaging (MRI) of Appendicitis in Children

Summary: Study to find out if MRI can diagnose appendicitis in children as well as or better than CT scan and/or ultrasound scan performed at the same time. No additional contrast material or sedation will be used to perform the MRI.
Inclusion criteria: inclusion criteria:

 Age 8-18 years, referred from emergency department for suspected appendicitis and receiving either CT scan or ultrasound of the abdomen for diagnosis

Exclusion criteria: :

 Failure to pass MRI metal screening. Claustrophobia or need for sedation due to inability to hold still.


Detection of Human Chorionic Gonadotropin by Interferometry in Gestational Trophoblastic Disease

Summary: We will try to use the novel analytical technique -Dual Polarisation Interferometry (DPI),to achieve detection the minimal amount of the human chorionic gonadotropin for early detection and strict monitor of the GTD.
Inclusion criteria: inclusion criteria:

 Hydatidiform Mole

 Choriocarcinoma

 Gestational Trophoblastic Neoplasms

Exclusion criteria: :

 Unwilling to participate in the study

['chemotherapy agents', 'suction curettage']

:

 Unwilling to participate in the study


Prevalence and Early Markers of Atherosclerosis in Adults With a History of Kawasaki Disease

Summary: Kawasaki disease (KD) is an acute systemic vasculitic syndrome with coronary tropism.~It has been reported worldwide, but it is ten times more common in Asian population. The annual incidence in children under 5 years in Europe is estimated at 8 to 100000. It is the second vasculitis of the child by its frequency after rheumatoid purpura. It occurs in 80% of cases between 1 and 5 years, with a maximal incidence around the age of 12 months.~It may results in acquired heart disease in children in developed countries, and may be the cause of premature coronary artery disease in adulthood.~A polymorphism was recently associated with the occurrence of disease in a Japanese and U.S population. (C allele of SNP itpkc_3, with a risk multiplied by 2). However, data are conflicting on this issue and the prevalence of this allel is unknown in North America and Europe populations.~The clinical picture of KD associate a persistent fever and an antipyretics resistance with mucocutaneous signs and bulky cervical lymphadenopathy usually unilateral. Diagnosis is confirmed by the presence of five clinical signs (major criteria). The presence of inconsistent coronary lesions in cardiac ultrasound can confirm the diagnosis.~KD can resolve spontaneously with no treatment. The severity of the disease is primarily related to complications of coronary aneurysms in acute or chronic stages.~Several arguments support the fact that adult patients have diffuse vascular lesions different from aneurysmal lesions initially described in childhood.~Despite abundance of publications on KD, there is no prospective or retrospective study which explored anomalies resulting from KD in adult subjects.~Therefore, this project will describe the patient's vascular evolution, the prevalence of atherosclerotic lesions and to determine the biological and functional abnormalities, markers of accelerated atherosclerosis.~Hypothesis : A history of Kawasaki disease represents a cardiovascular risk factor in adulthood.~The main objective is to evaluate the prevalence of atherosclerotic lesions, their extent and their severity in adults with a history of KD in childhood compared to a control population.
Inclusion criteria: inclusion criteria:

 History of KD before the age of 18, with or without macroscopic coronary lesions in the childhood phase. (KD group only)

 18 years old or older at the time of the study.

 Agree on participating to all explorations of the study.

 Accept genotyping.

 Absence of cardiovascular risk factors

Exclusion criteria: :

 Atypical KD (KD group only)

 Documented or suspected coronary ischemia,

 Refusal to participate to the study or sign the consent

 Contra-indication to the injection of iodinated contrast agents (allergy, renal failure)

 Hypersensitivity to dobutamine,

 No effective contraception method for females with child bearing potential,

 Breastfeeding, or pregnant females,

 Treatment modifying endothelial reactivity

 History of severe intolerance to iodinated contrast agents,

 Subjects who can't hold their breath for at least 20 seconds,

 Irregular or absence of sinus rhythm, especially atrial or ventricular arrhythmia

 Unability to give information to the subject,

 No coverage from a Social Security system

 Deprivation of civil rights


Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus

Summary: This study is being done to see if a new approach to repair perforated ulcers in the stomach (holes in the stomach) or the first part of the intestine is possible. Traditionally, either open operations (large single incision) or laparoscopic operations (multiple small camera-guided incisions) have been used to repair perforated ulcers. Over the last ten years, some surgeons have used endoscopic equipment to assist them with performing the procedure. It is unknown if perforated ulcer repair can be done using an endoscope as the main instrument (a flexible tube with a video camera inserted into the stomach through your esophagus) to patch or plug the perforation. We will patch the perforation using a standard method which uses tissue from outside the stomach. A laparoscopic camera will also be used to assist our view. This study is intended to be a feasibility study to demonstrate the endoscopic technique can be safely performed~Hypothesis: The primary outcome is successful completion of the procedure.
Inclusion criteria: inclusion criteria:

 Patients presenting with clinical diagnosis of a perforated viscus who are scheduled to undergo surgical intervention

 Surgical candidate for endoscopic, laparoscopic, or open procedure

 Age > 21

 Informed written consent

Exclusion criteria: :

 Prior gastric or duodenal surgery

 Prior total abdominal colectomy or transverse colectomy

 Prior omentectomy or omental flaps

 Known perforation site other than stomach or duodenum

 Patients with contra-indications for laparoscopy

 Patients with contraindications for endoscopy

 Upper gastrointestinal anatomy that would preclude endoscopic therapy

 Coagulopathy or thrombocytopenia

 Pregnant patients

 Patients <21 years of age

 Prisoners

 Patients found at surgery to have disease processes other than perforated peptic ulcer disease will be asked for permission to record their data for comparison

['Endoscopic Translumenal Omental Patch']


T.E.A. Study Three Days Ertapenem Versus Three Days Ampicillin- Sulbactam

Summary: The aim of the study was to compare the activity (efficacy and safety) of Ertapenem administered according to a short treatment for three days versus a short treatment for three days with AS in patients with an community acquired IAI of mild to moderate severity.
Inclusion criteria: inclusion criteria:

 Adult patients ( > 18 years) requiring surgical intervention within 24 hours of diagnosis, for localized IAI infections (i.e extending beyond the organ wall but confined near the hollow viscus, mild to moderate in severity):

 Acute appendicitis: Ruptured or perforated with abscess

 Acute diverticulitis with perforation and/or abscess

 Acute cholecystitis (including gangrenous) with either rupture or perforation

 Acute gastric and duodenal ( > 24 hours) perforation

 Traumatic (> 12 hours) perforation of the intestines

 Secondary peritonitis due to perforated viscus

 Intra-abdominal abscess (including of liver and spleen)

Exclusion criteria: :

 Traumatic bowel perforation requiring surgery within 12 hours

 Perforation of gastroduodenal ulcers requiring surgery within 24 hours

 other intra-abdominal processes in which the primary etiology was unlikely to be infectious.

 Patients lactating or pregnant

 Patients with a history of allergy, hypersensitivity, or any severe reaction to the study antibiotics

 Patients with rapidly progressive or terminal illness;

 Patients with a history or presence of severe hepatic or renal disease (e.g. creatinine clearance < 0.5 ml/min/1.73 m2);

 Patients with a concomitant infection that would interfere with evaluation of response to the study antibiotics.


Rabies Virus Neutralizing Activity and Safety of CL184, a Monoclonal Antibody Cocktail, in Simulated Rabies Post-Exposure Prophylaxis in Healthy Adults

Summary: Study design:~Single-blind (subject and observer-blinded), active-controlled, randomized [6:2:1:2:1; CL184 + purified vero cell rabies vaccine (PVRV) vs. human rabies immune globulin (HRIG) + PVRV vs. placebo + PVRV vs. CL184 + human diploid cell vaccine (HDCV) vs. placebo + HDCV], mono-center study~Study objectives:~Primary: To evaluate the safety of CL184 in combination with PVRV in healthy adult subjects.~Secondary: To evaluate the safety of HRIG or placebo in combination with PVRV and to evaluate the safety of CL184 or placebo in combination with HDCV in healthy adult subjects. To evaluate the rabies virus neutralizing activity (RVNA) after administration of CL184 or placebo in combination with PVRV, of HRIG in combination with PVRV, and of CL184 or placebo in combination with HDCV in healthy adult subjects. To evaluate the pharmacokinetics of the monoclonal antibodies (mAbs).
Inclusion criteria: inclusion criteria:

 Male or female subject aged ≥18 to ≤55 years

 Subjects free of obvious health-problems or with stable conditions or medications

 Body mass index between ≥18 to ≤30 kg/m2

 Abstinence from sexual intercourse or use of adequate contraception from the date of screening up to Day 90

 Male subjects must agree that they will not donate sperm from the first check-in until Day 90

 Subject signed written informed consent

Exclusion criteria: :

 Prior history of active or passive rabies immunization

 Clinically significant acute illness or infection including fever (≥38 °C) within 2 weeks before first dosing

 History and/or family history of clinically significant immunodeficiency or auto-immune disease

 Planned immunization with live vaccines during the coming 3 months after first dosing

 Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product

['Rabies virus-specific monoclonal antibodies', 'human polyclonal rabies immune globulin (HRIG)', 'Placebo', 'Human diploid cell vaccine (HDCV)', 'Purified verocell rabies vaccine (PVRV)']


Surgery Plus Radiation Therapy With or Without Chemotherapy in Treating Children With Primitive Neuroectodermal Tumors of the CNS

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether undergoing surgery plus radiation therapy is more effective with or without chemotherapy for primitive neuroectodermal tumors of the CNS.~PURPOSE: Randomized phase III trial to compare the effectiveness of surgery plus radiation therapy with or without chemotherapy in treating patients who have primitive neuroectodermal tumors of the CNS.
Inclusion criteria: DISEASE CHARACTERISTICS: Histologically proven primitive neuroectodermal tumors of the central nervous system No metastatic disease within or outside the central nervous system Must have survived 1 week following surgery Postoperative CT scan and myelogram required

 PATIENT CHARACTERISTICS: Age: 3 to 16 Performance status: Not specified Life expectancy: Not specified Hematopoietic: No concurrent hematological disorder Hepatic: Not specified Renal: Renal dysfunction allowed Other: No prior history of malignant disease

 PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics
Exclusion criteria:

['carboplatin', 'cyclophosphamide', 'etoposide', 'vincristine sulfate', 'surgical procedure', 'radiation therapy']

carboplatin
cyclophosphamide
etoposide
vincristine sulfate
surgical procedure
radiation therapy

['Brain and Central Nervous System Tumors']


S. Japonicum and Pregnancy Outcomes

Summary: The purpose of the study is to understand whether the drug praziquantel (PZQ) is safe for the mother and developing baby when the mother has schistosomiasis (a type of worm) infection, and whether the drug may improve the mother's and baby's health. The usual practice is to wait until after a mother has finished breast feeding before giving the medicine. Approximately 375 infected pregnant women, ages 18 and over, in endemic villages in Leyte, The Philippines will participate. Study volunteers 12-16 weeks pregnant will be given PZQ or an inactive pill (placebo) and stay in the hospital overnight. Small blood samples will be collected before and after the medication is taken. Three stool and urine samples will be taken during a total of 7 study visits. An ultrasound image (picture or outline of the unborn baby) will be performed. When the baby is born, a small blood sample will be taken. Mother and baby will be followed for up to 8 months before the baby is born and 1 month after.
Inclusion criteria: inclusion criteria:

 For screening:

 Female, age 18 or over.

 Present to a study midwife with suspected pregnancy.

 Live in a study village.

 For the main study:

 Infected with S. japonicum.

 Pregnancy as determined by urine pregnancy test.

 Age 18 or older.

 Participant is otherwise healthy as determined by history, physical exam, ultrasound and laboratory assessment.

 Pregnancy between 12-16 weeks gestation.

 Ability to provide informed consent to participate.

Exclusion criteria: :

 Presence of significant disease/illness that is either acute or chronic. This will be defined by history, physical examination, ultrasound and laboratory assessment. In particular:

 History of seizures or other neurologic disorder, chronic medical problem determined by history or physical examination, e.g. active hepatitis, tuberculosis, heart disease.

 Grade 3 or higher laboratory abnormality of blood urea nitrogen (BUN), Creatinine, bilirubin, white blood cell count, or platelet count will warrant exclusion. Grade 2 or higher abnormality of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) will warrant exclusion. For hemoglobin, women with severe anemia defined as hemoglobin less than 7.0 g/dl will be excluded.

 Women with myoma on ultrasound that are sub-mucosal or women with myoma that is in any location and greater than 5 cm in size.

 Women with congenital anomalies of the reproductive tract that would be expected to cause decreased fetal weight or greatly increase the risk of prematurity such as duplicate uterus, uterine septum.

 For less clear cases, the researchers will define significant illness as one that significantly alters a woman's ability to perform activities of daily living, causes symptoms at least two days per week, or necessitates regular use of medication. In the case of acute medical conditions such as urinary tract infection, pneumonia, febrile illness, enrollment may be postponed until the illness is successfully treated (not currently on any medication for the illness) or the illness self resolves if this occurs before 16 weeks gestation.

 Presence of cysts in the eye suggestive of neurocysticercosis.

 Regular use of a medication for a chronic medical condition.

 History of severe allergic reaction (anaphylaxis, facial swelling, or difficulty breathing) or seizure with praziquantel administration.

 Fetus has congenital anomaly determined by 12-16 week ultrasound or is determined to be nonviable (e.g. blighted ovum).

 Twin or higher order pregnancy.

 Woman has been enrolled into this study for a previous pregnancy.

 Inability to comprehend study procedures and provide informed consent due to limited cognitive abilities or other, or refuses to provide informed consent.


Service Member Fatigue and Lack of Motivation Following Concussion

Summary: Background:~- Many service members have reported feeling tired, a loss of motivation, mood changes, and problems working with others after they have a concussion during deployment. These problems may lead to problems with their job and relationships. This study hopes to figure out what parts of the brain may be affected in people with these problems after a concussion.~Objectives:~- To learn more about the problems that may occur after service members have a concussion during deployment and return home.~Eligibility:~Service members or veterans between 18 and 40 years of age who have had a mild traumatic brain injury (concussion) in the past 6 months.~Companions (at least 18 years of age) of the service members will also be included in this study. Companions will have interacted with the service member at least 1 hour a week since deployment.~Design:~Service members will have 1 week of tests at the National Institutes of Health Clinical Center. Companions will have 2 days of tests at the Center.~Each day, service members will have 4 or 8 hours of tests. Tests will include a medical history and physical exam, neuropsychological tests and imaging studies. The tests will ask about fatigue, stress, mood, pain, daily activities, and family support. The imaging studies will measure brain function at rest and during activity.~Companions will have a medical history and physical exam. They will also complete several questionnaires about themselves as well as the service member/veteran. The tests will ask about fatigue, stress, mood, pain, daily activities, and family support....
Inclusion criteria: inclusion criteria mTBI GROUP:

 Diagnosis of at least one mTBI during deployment;

 At least six months from time of injury;

 Age range 18 or older;

 A self-report of somatic or behavioral symptoms that developed within 3 months following mTBI and were not present before injury, and may or may not be present at enrollment:

 Easy fatiguability

 Sleep disturbance

 Headache or other chronic widespread pain that does not seem related to extremity injury

 Emotional lability

 Lack of spontaneity or apathy

 Lack of motivation

 Feelings of anxiety

 Personality change that they or others have noticed

 Irritability or aggressiveness

 The mTBI participant provides informed consent.

Exclusion criteria:  mTBI GROUP:

 Daily use of stimulants, narcotics, hypnotic or anxiolytics

 Diagnosis of sleep apnea, thyroid disorder, or rheumatoid arthritis

 Any history of head injury associated with a loss of consciousness that lasted longer than 24 hours (not including sedation);

 Daily use of more than 600mg caffeine (equivalent to approximately five cups of coffee).

 Headaches more than once a month prior to deployment;

 Pregnancy;

 Claustrophia;

 Inability to comfortably lie supine for two hours

 inclusion criteria companion group

 Chosen by a mTBI participant as a close companion (i.e, spends or in the last 3 years has spent a minimum of 1 hour per week on average with the mTBI participant and with whom the mTBI participant is comfortable discussing personal matters);

 The companion provides informed consent.


Long Term Use of Valganciclovir for Prophylaxis of CMV Disease in Kidney and Pancreas Transplant Patients

Summary: CMV viral disease negatively affects transplant patients. CMV is the most prevalent infection in transplant patients and 3 month drug regimens to prevent the virus have been mostly unsuccessful, usually after the drug has been stopped, the patient develops the viral disease. Extended use of anti-viral drugs may, in fact, may lead to the development of resistant virus. We hypothesize that extended use (12 months) of valganciclovir (Valcyte™)will not only be efficacious but will not be associated with the development of resistant CMV.~Sample Size: 100 patients at 3 sites have been enrolled~Patient Selection: Adult (>18 years) recipients of cadaveric or living donor kidneys, pancreas, or combine kidney-pancreas transplants.~Immunosuppression: To be determined according to each center's standard protocol (s).~Study Drug: Valcyte™ Days 0 - 90: All Patients, 900 mg QD~Days 91 - 365:~Group 1: 900 mg QD Group 2: 450 mg QD~Assessment of Valgancicovir (Valcyte™)Resistant CMV : Serial serum samples (at transplant, 6 weeks, and 3, 6, 9 and 12 months post-transplant) for PCR amplification and DNA sequence analysis from detectable CMV to identify the presence of mutations within the UL97 and UL54 genes.~Other Analyses:~Additional information will be evaluated relating to the development of CMV disease, development of ganciclovir toxicity, graft rejection or graft loss and patient death. Preliminary information regarding the predictive value of DNA assays for the development of CMV disease will be evaluated.
Inclusion criteria: inclusion criteria:

 1) Age greater than 18 years 2) WBC greater than 2000/mm3 with ANC greater than 500/mm3 3) Platelet count greater than 50,000/mm3 4) Hematocrit greater than 24 5) Life expectancy greater than 1 year as determined by investigator 6) Females must have a negative pregnancy test and any sexual partner must also agree to practice a barrier and/or hormonal method of birth control while participating in this study and for 90 days after. Females must agree to have a pregnancy test if a menstrual cycle is missed, and if positive, this must be reported.

 -

Exclusion criteria: :

 Patients receiving systemic therapy for acute opportunistic infection at time of enrollment

 Patients receiving investigational drugs

 Patients with malignancies within the last 5 years with the exception of excised basal or squamous cell skin cancers

 Patients with active substance abuse or other condition that would impair compliance

 Patients who are unable to give informed consent

 Any patient with a creatinine clearance < 40 after delayed graft function and or post-transplant ATN has completely resolved, or the patient is deemed not to have the prospect of any further improvement of creatinine clearance (>40) as would occur with resolving ATN.

 Persistent ANC < 1,000 for 2 consecutive weeks despite treatment with G-CSF

 Any female patient who plans to become pregnant within one year

['CMV Disease', 'Viral Resistance', 'Rejection', 'Death']

CMV Disease
Viral Resistance
Rejection
Death


Study of Resting and Exercising Body Functioning in Freeman-Sheldon Syndrome and Related Conditions

Summary: The hypotheses of the present study of Freeman-Sheldon syndrome (FSS) and related conditions are: (1) that exercise capacity is lower in FSS patients versus normal controls, and the lower exercise capacity is due to changes in the muscles' normal structure and an inability of sufficient quantity of the energy molecule to bind to muscle; (2) this muscle problem reduces amount of air that can get in the lung and amount of oxygen carried in the blood, which then has the effect of increasing heart and respiration rates, blood pressure, and deep body temperature, and produces muscle rigidity; (3) the events noted above, when they occur during cardiac stress testing, are related to a problem similar to malignant hyperthermia (MH) reported in some muscle disorders without use of drugs known to cause MH. MH (a life-threatening metabolic reaction that classically is triggered when susceptible persons receive certain drugs used in anaesthesia.
Inclusion criteria: Syndrome Group inclusion criteria:

 Freeman-Sheldon syndrome,

 Sheldon-Hall syndrome,

 Distal arthrogryposis type 1, or

 Distal arthrogryposis type 3

 Deceased patients with enough clinical information available to satisfy study requirements

 Syndrome Group
Exclusion criteria: :

 Individuals not confirmed to have a condition under study

 Deceased patients without enough clinical information available to satisfy study requirements

 Patients with other anomalies, not having one of the above syndromes

 Patients or parents of minor children not willing to give consent

 Mature female patients who are pregnant or breast-feeding will be reassessed for consideration for enrolment.

 Mature female patients who are currently experiencing menses will be reassessed for consideration for enrolment.

 Patients with active, acute comorbid illness will be reassessed for consideration for enrolment.

 Control Group inclusion criteria:

 Subjects must be healthy and free of active disease.

 Subject or parent of minor child must be willing to give consent.

 Subjects must fall within the age-bracket to be matched with a Syndrome Group patient already screened and enroled in the study

 Subjects must be non-tobacco users and non-drinkers.

 Control Group

['Lactate, Glucose, and Adenosine Triphosphate Blood Levels', 'Physiological Stress Test', 'Functional Enquiry Form', 'Strength, Joint ROM, Girth and Length Measurements', 'Study Physical Examination', 'Observational Gait Analysis', 'Mental Health Interview']

Lactate
Glucose
and Adenosine Triphosphate Blood Levels
Physiological Stress Test
Functional Enquiry Form
Strength
Joint ROM
Girth and Length Measurements
Study Physical Examination
Observational Gait Analysis
Mental Health Interview


A Blood Pressure Regulation and Stroke Risk Evaluation Study in Hypertensive Patients Treated With Eprosartan

Summary: The primary objective of the study is to evaluate the proportion of hypertensive patients who achieve regulation of their blood pressure (BP) levels according to the European Society of Cardiology / European School of Haematology (ESC/ESH) Guidelines, after treatment with eprosartan for 6 months under standard medical practice conditions. The absolute change in Systolic blood pressure from baseline will also be calculated.~This study also aims in the evaluation of Framingham stroke risk profile score of patients treated with eprosartan under standard clinical practice conditions during the observation period. Besides the primary and the secondary objective of the study, the assessment of the percentage of patients who experienced Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs) (overall and per observed event) and the percentage of patients who discontinued treatment prematurely before the advent of the 6-month observation period due to toxicity to the study medication constitutes another important objective that is related to the safety of the treatment.
Inclusion criteria: inclusion criteria:

 Adult patients (age greater or equal to 18 years)

 Hypertensive patients, with a sitting Systolic Blood Pressure above 140 mmHg or 130 mmHg in diabetics and high/very high risk patients, according to ESC/ESH Guidelines

 Patients being prescribed eprosartan under the terms and conditions of the local label and administered according to standard medical practice

 Patients with at least one of the following conditions:

 Newly diagnosed hypertension,

 Inability to tolerate other antihypertensive medications, or

 Lack of response to current antihypertensive medication(s)

Exclusion criteria: :

 1. Any contraindication to eprosartan or the excipients (according to the local label)


Benefits of Liquid Oxygen in COPD Patients Presenting Desaturation During Exercise.

Summary: The purpose of this study is analyzed the impact of oxygen adjusted during exercise in COPD patients without conventional for LTOT but with exercise desaturation.
Inclusion criteria: inclusion criteria:

 Clinical stable moderate to severe COPD (FEV1 <70%, FEV 1 / FVC <70%) total lung capacity (TLC> 80%) without conventional criteria for LTOT, optimal medical therapy, mean SpO2 ≤ 88% during the 6 minuts walking test and active life outside the home, other than active smoking or are in program respiratory rehabilitation.

Exclusion criteria: :

 Current smokers - Presence of respiratory failure and criteria for LTOT (PO2 <55 mmHg or 55-60 mmHg associated with pulmonary arterial hypertension, chronic cor pulmonale, congestive heart failure, arrhythmias or polycythemia). - Presence of impaired mobility - Cognitive impairment or intellectual disability to fill in questionnaires - No acceptance of liquid oxygen - Presence of active comorbidities (cardiovascular disease, rheumatologic, renal, hepatic) - Participation in pulmonary rehabilitation programs

['Pulmonary Disease, Chronic Obstructive']


New Clinical Applications for Internet-based Cognitive Behavior Therapy for Insomnia and Depression

Summary: This study includes two sub-trials. Both are included in this singe registration since they have parallel inclusion of participants and have been approved by the Swedish ethics board together in one application.~Trial 1 includes patients with both insomnia and major or minor depression. Participants are randomized to either a combined therapist guided Internet-CBT for insomnia and depression, or to Internet-CBT for depression with an addition of a placebo intervention for insomnia. The primary purpose is to evaluate changes in insomnia and depression severity for the combination treatment compared to the depression treatment, after treatment and at 6 and 36 months follow up. A secondary purpose is to evaluate cognitive functioning before and after treatment, as well as cost effectiveness. Recruitment is done in the Stockholm County through mass media and the Internet psychiatry clinic's regular patient recruitment.~Trial 2 includes patients with insomnia who do not meet criteria for major or minor depression. All participants start therapist guided Internet-CBT for insomnia. After 4 weeks patients that are judged to be at risk of treatment failure are randomized to either continued treatment or treatment with added support intended to enhance outcome. The primary purpose is to evaluate change in insomnia severity for participants who get added support, compared to continued treatment with regular support level. A secondary purpose is to evaluate cognitive functioning before and after treatment, as well as cost effectiveness. Recruitment is done in the Stockholm County through mass media and the Internet psychiatry clinic's regular patient recruitment.~NOTE:~The first participants in trial 1 will be regarded as pilots, due to problems with the experimental treatment: technical issues as well as problems with the design of treatment modules. These problems were corrected when discovered. 12 participants in the experimental arm were affected by these errors. The pilot participants will not be included in the main analyses of data. This was decided upon on 31st of October 2014.
Inclusion criteria: inclusion criteria:

 Clinical level of Insomnia (more than 10 on ISI)

 Meets criteria for Insomnia according to DSM-IV-TR

 Enough language skills

 Only Trial 1: Meets criteria for Major or Minor Depressive Disorder according to DSM-IV-TR (for minor depression a MADRS-S-level of >19 is required).

Exclusion criteria: :

 Sleep disorders requiring other treatment

 Alcohol/drugs abuse

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

 Somatic or psychiatric conditions requiring acute care

 Working night shifts

 Only Trial 2: Meets criteria for Major or Minor Depressive Disorder according to DSM-IV-TR (for minor depression a MADRS-S-level of >19 is required for exclusion).

['Therapist guided Internet-CBT for insomnia w. extra support', 'Therapist guided Internet-CBT for insomnia', 'Therapist guided Internet-CBT for insomnia and depression', 'Therapist Guided Internet-CBT for depression plus insomnia placebo']

['Insomnia', 'Major Depression', 'Minor Depression']

Insomnia
Major Depression
Minor Depression


A Study to Identify and Characterise Bacteria Causing Chronic Cough Among Children in United Kingdom

Summary: The purpose of this study is to investigate the role of Haemophilus influenzae and other bacteria in causing chronic cough, through a direct comparison of chronic cough cases and healthy controls recruited from paediatric respiratory clinics in the United Kingdom.
Inclusion criteria: inclusion criteria:

 Subjects who the investigator believes that parent(s)/ legally acceptable representative can and will comply with the requirements of the protocol.

 A male or female child between, and including, six to 72 months of age at the time of enrolment.

 Written informed consent obtained from the parent(s)/ legally acceptable representative of the subject.

 No antibiotic therapy within four weeks prior to the visit.

 No cystic fibrosis or known major immunodeficiency such as agammaglobulinaemia, T cell deficiency or Human Immunodeficiency Virus / Acquired Immune Deficiency Syndrome.

 No documented evidence or suspicion of gastroesophageal reflux disease.

 No evidence of an upper viral respiratory infection four weeks prior to the visit.

 In addition, all subjects regarded as 'cases' must satisfy all the following criteria at study entry:

 Persistent cough greater than eight weeks.

 No response to five-day prednisolone treatment.

 Chest X-ray showing no evidence of a lobar pneumonia or gross structural abnormality.

 In addition, all subjects regarded as 'controls' must satisfy the following criteria at study entry:

 No respiratory symptoms four weeks prior to the visit.

 No documented evidence or suspicion of lung disease upon physical examination.

Exclusion criteria: :

 Concurrently participating in another study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.

 Use of any investigational or non-registered product within 30 days prior to study procedures, or planned use during the study period.

 Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

 Child in care.

['Cough swab', 'Oropharyngeal swab', 'Nasopharyngeal swabs', 'Blood sample', 'Bronchoscopy/ bronchoalveolar lavage samples', 'Data collection']


Multicenter Validation on Predicting Mortality for Patients With Bleeding Peptic Ulcers

Summary: This study aimed to validate CU prediction model on mortality for patients with high risk bleeding peptic ulcers after therapeutic endoscopy.
Inclusion criteria: inclusion criteria:

 Patients presented with bleeding peptic ulcers

 Age > 18 year old

 Informed consent for the study and OGD

Exclusion criteria: :

 Unable or refuse to give consent

 Onset more than 7 days

 Pregnancy


A Study of the Interaction Between Tumor Susceptibility Gene Glycine N-methyltransferase (GNMT) and Lung Cancer

Summary: Environmental carcinogens such as polycyclic aromatic hydrocarbons (PAHs) were reviewed as the major risk factors for lung cancer development. In this proposal, the investigators collected fifteen kinds of major PAHs and the investigators would like to perform the following studies:~Study the gene expression and subcellular localization of GNMT in the normal-tumor tissue pairs of lung cancer patients.~Study the associations of the polymorphisms of GNMT in lung cancer patients and the susceptibility to lung cancer;~To assess the allelic loss at GNMT and determined the LOH rate of GNMT in the normal-tumor tissue pairs of lung cancer patients.~Study the associations of the copy number variation (CNV) of GNMT and the susceptibility to lung cancer;~Study the interaction between GNMT and polycyclic aromatic hydrocarbons (PAHs) in lung cancer cell lines.
Inclusion criteria: inclusion criteria:

 Participant is a lung cancer patient.

Exclusion criteria: :

 Participant is under 18 years old.

 Participant is not a lung cancer patient.


In-house Produced PMMA- Versus PEEK-cages

Summary: Subsidence of cervical cages is a common problem. For the study, a new polyacrylmethacrylate cage was designed and prospectively implanted in patients with a mono- or bilevel cervical pathology. As control, a commercially available PEEK-cage was used, patients were randomized using minimization randomization, controlling for age and bone mineral densitiy. The investigators hypothesize that the newly developed cage has similar clinical and radiological qualities compared to the PEEK-cage, but at a much more favourable cost-performance ratio.
Inclusion criteria: inclusion criteria:

 virgin spines

 no emergency operation

 age above 18

 sufficient knowledge of the German language

 indication for anterior cervical discectomy and fusion

 absence of concomitant spinal disease

Exclusion criteria: :

 prior cervical surgery

 indications other than ACDF

 concomitant neoplastic, metabolic, severe general or infectious disease

['Implantation of a PEEK-cage', 'PMMA-cage']

['Cervical Disc Degeneration', 'Cervical Stenosis']

Cervical Disc Degeneration
Cervical Stenosis


Psychological Treatment for Children Suffering From Post Traumatic Stress Symptoms and Mild Traumatic Brain Injury

Summary: The purpose of this study is to determine whether Prolonged Exposure Therapy (PE)is effective in the treatment of post-traumatic stress symptoms in children and adolescents with mild traumatic brain injury (m-TBI) due to motor vehicle accident.
Inclusion criteria: inclusion criteria:

 For the whole sample:

 Children age 6 to 18

 Language spoken: Hebrew, Arabic

 DSM- IV R diagnosis: PTSD

 Car accident event within past 3 years

 For the m-TBI group:

 Any of the following symptoms or experiences occurring during or shortly after the accident: loss of consciousness, dazed, confused, saw stars, headache, dizziness, irritability, memory gap (not remembering injury or injury period), visual loss, abdominal pain].

 Diagnosis of MTBI within 3 years as confirmed by CT/MRI/fMRI.

 Glasgow coma scale; GCS<15.

Exclusion criteria: :

 Children presenting with psychotic symptoms

 Children presenting with mental retardation

['PTSD', 'Traumatic Brain Injury', 'Post Concussive Syndrome']

PTSD
Traumatic Brain Injury
Post Concussive Syndrome


Concussion and Post Traumatic Stress in Traumatic Brain Injury

Summary: Mild brain injury or concussion affects about four million Americans each year. Some people recover completely while others, especially those with multiple concussions, develop chronic headaches, neurodegenerative diseases and psychiatric disorders. One of the reasons that concussion is difficult to treat is that it is difficult to detect. Radiographic studies such as CT (computed tomography scan) are by definition unrevealing of structural injury in concussed patients. Some MRI (magnetic resonance imaging) sequences may be useful adjuncts in the diagnosis of concussion but even these are not consistently present in all patients with symptoms. Clinical tests for concussion often require baseline studies, and thus are generally reserved for athletes and others at highest risk for concussion.~The investigators have developed a novel eye movement tracking algorithm performed while subjects watch television or a music video that determines whether the eyes are moving together (conjugate) or are subtly not together (disconjugate). The investigators preliminary data shows that people with lesions in their brain or recovering from brain injury have disconjugate gaze that is not detectable by ophthalmologic examination but is detected by our algorithm.
Inclusion criteria: inclusion criteria:

 All patients will be recruited from the Bellevue Hospital Emergency Services (Emergency Department and Trauma Bay) or from among inpatient populations at Bellevue Hospital. They will need to be consentable and able/willing to participate and meet criteria for distribution into one of the three subject populations (structural TBI, non-structural TBI, injured/non-TBI) described here:

 mild to moderate structural traumatic brain injury (TBI) as evidenced by CT scan demonstrating the presence of hemorrhage (subdural, epidural, subarachnoid or intraparenchymal), brain contusion, or skull fracture.

 non-structural TBI(concussion), meaning no signs of structural injury on imaging; however, they complain of usual brain injury symptoms such as headache, dizziness, cognitive impairments, etc., A subject with a traumatically induced physiological disruption of brain function, manifested by >1 of the following:

 Any period of loss of consciousness (LOC).

 Any loss of memory for events immediately before or after the accident.

 Any alteration in mental state at the time of accident (i.e. feeling dazed, disoriented, or confused).

 Focal neurological deficit(s) that may or may not be transient, but where the severity of the injury does not exceed the following:

 Loss of consciousness of approximately 30 minutes or less

 After 30 minutes, an initial Glasgow Coma Scale (GCS) of 13-15

 Posttraumatic amnesia (PTA) not greater than 24 hours.

 Non-brain injured subjects that have suffered some type of injury such as to the extremities or other parts of the body. The subjects will have sustained a blunt or penetrating trauma such as, to the corpus or extremities (i.e. car accident, falling).

Exclusion criteria: :

 Subjects that receive minor penetrating trauma insufficiently traumatizing to result in sufficient sequelae will be excluded.

 Subjects suffering burns, anoxic injury or multiple/extensive injuries resulting in any medical, surgical or hemodynamic instability will also be excluded.

 Particularly for the purposes of eye tracking all subjects that are blind (no light perception), are missing eyes, do not open eyes will be excluded from the research.

 It is pertinent that subjects be able to detect light and have both eyes in order for the eye tracking data to be effective and significant.

 Any physical or mental injury or baseline disability rendering task completion difficult will be excluded, also inability to participate in longtitudinal care, or obvious intoxication or blood alcohol level greater than 0.2.

 Pregnant individuals and prisoners will also be excluded from the study.

['Concussion', 'Stress Disorders, Post-Traumatic']

Concussion
Stress Disorders
Post-Traumatic


Standard Dose Versus High-Dose Inactivated Flu Vaccine in Pediatric Solid Organ Transplant Patients

Summary: This is a phase I trial in which the both the safety and immunogenicity of the standard dose flu vaccine will be compared with high dose flu vaccine in children that have undergone solid organ transplantation (SOT).
Inclusion criteria: inclusion criteria:

 Pediatric SOT patients (kidney, liver, heart, lungs, intestine, and/or multi-visceral)

 Must be at least 6 months after transplant.

 3-17 years of age, inclusive.

 Available for duration of study.

 Parent or guardian able to be reached by phone.

Exclusion criteria: :

 History of hypersensitivity to previous influenza vaccination or severe hypersensitivity to eggs/egg protein.

 History of Guillian-Barre syndrome.

 Receipt of rituximab within the past one year.

 Rejection treatment with intravenous steroid bolus within 30 days.

 Rejection treatment with monoclonal antibody or antilymphocyte preparation (e.g. Alemtuzumab, Muromonab-CD3, etc.) within 90 days.

 Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol.

 Have any condition that the investigator believes may interfere with successful completion of the study.

 History of received 2011-2012 influenza vaccine.

 Pregnant female.

 History of proven influenza disease after September 1, 2011.

 History of known infection with HIV, hepatitis B, or hepatitis C.

 History of known latex hypersensitivity.

['High-Dose trivalent inactivated influenza vaccine', 'Standard dose trivalent inactivated influenza vaccine']

['Pediatric Solid Organ Transplant Patients']


Combined NMES,FEES and Traditional Swallowing Rehabilitation in the Treatment of Stroke-related Dysphagia

Summary: The investigators aimed to evaluate effects of combined NMES, FEES and traditional swallowing rehabilitation in stroke patients with moderate-to-severe dysphagia.
Inclusion criteria: inclusion criteria:

 age between 20-85 years old

 first-time stroke confirmed by computed tomography or magnetic resonance image

 dysphagia > 3 weeks, with preservation of the swallowing reflex

 currently on a restricted diet, with a Functional Oral Intake Scale (FOIS) score of 5 or less

 Mini-Mental State Examination (MMSE)> 21

 no obvious mental depression, receptive aphasia or cognitive impairment

Exclusion criteria: :

 progressive cerebrovascular disease or other neurologic diseases

 unstable cardiopulmonary status, serious psychologic disorder or epilepsy;

 tumors, extensive surgery or radiotherapy of the head and neck region

 cardiac pacemakers

 swallowing therapy within 2 months before participation


Taenia Solium Elimination Versus Control: What is the Best Way Forward for Sub-Saharan Africa?

Summary: Taenia solium taeniosis/cysticercosis is a neglected zoonotic parasitic disease complex with significant economic and public health impacts, occurring primarily in developing countries. Humans are the carriers of the tapeworm (taeniosis); the normal intermediate pig host develops the metacestode larval stage (porcine cysticercosis). However, people can also act as accidental intermediate hosts and develop human cysticercosis or neurocysticercosis (NCC) when the central nervous system is involved.~The scattered efforts of researchers into evaluation of control programmes in Sub-Saharan Africa (SSA) have focussed on single control options. It is becoming clear that these stand-alone options have the potential to reduce the occurrence of the parasite, however either long term or more integrated efforts seem to be required to reach an elimination status.~The objective of the current study is to evaluate the cost-effectiveness/acceptability of elimination (to be achieved on a short term via integrated measures), and control (single measures, with an elimination goal on a longer term) of T. solium in a highly endemic area in SSA.~This intervention study will entail an elimination study arm in which multiple control options are combined (integrated) aiming at the final human host (Mass drug administration (MDA) and health education) and pig intermediate hosts (pig treatment and vaccination). In a second study arm a single control option will be carried out (pig treatment). In both study arms (health) education will be implemented. At baseline and in the final sampling year, prevalence of human taeniosis/cysticercosis and porcine cysticercosis will be determined in all study villages. Active ongoing surveillance and 6 monthly (biannual) human and pig sampling will be conducted in the elimination study arm, as well as two-yearly (biennial) sampling of the pig intermediate host in the control study arm. Additionally, (open ended) questionnaires and focus group discussions will be administered/held to obtain data on the cost of pig keeping, T. solium, the interventions and the perception/acceptability of the proposed control measures to the local communities.
Inclusion criteria: inclusion criteria:

 Willing and able to participate in all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey and group discussions, and taking oral anthelmintic tablets (the latter specific for the elimination arm)

 Willing and able to provide informed consent (signature or thumb print with impartial witness; assent for minors with parental consent).

 Living in, attending school in, or regularly visiting the bore holes present in, the study communities

 Aged five years of age or older

 People without epilepsy

Exclusion criteria: :

 Unwilling or unable to participate in some or all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey and group discussions, or taking oral anthelmintic tablets (the latter specific for the elimination arm)

 Unwilling or unable to provide written (signature or thumb print with impartial witness) informed consent (or assent for minors)

 Living outside of, and not regularly visiting, or attending school in, the study communities

 Children aged four years or younger

 People with epilepsy (identified cases by the Rural Health Centre, questions included in the registration procedure)

 Seriously ill individuals (people unable to engage in the normal activities of daily living without assistance because of their illnesses)

['Mass drug administration, praziquantel 10mg/kg', 'Health education']

Mass drug administration
praziquantel 10mg/kg
Health education


Osteoporosis Choice Decision Aid for Use of Bisphosphonates in Postmenopausal Women

Summary: To develop a decision aid to support the decision to use (or not use) bisphosphonates in postmenopausal women at risk for osteoporotic fractures, and to assess the impact of the decision aid on start and six month adherence to bisphosphonates.
Inclusion criteria: inclusion criteria:

 Female, post-menopausal women aged 50 to 90.

 Have a bone mineral density (BMD) evaluation resulting in a T-Score of <-1.0.

 Have a follow-up appointment with a provider in the areas of Family Medicine (FM), Primary Care Internal Medicine (PCIM), or POM.

 Have no major barriers (i.e., severe hearing impairment, dementia, require interpreter, etc.) to participation in shared decision-making (per provider's assessment)

 Enrollment is open to females of diverse racial backgrounds.

Exclusion criteria: :

 Currently taking a bisphosphonate.

 Not available for 6 month follow-up phone call.

['Osteoporosis', 'Bone Loss, Age Related', 'Postmenopausal Bone Loss', 'Postmenopausal Osteoporosis']

Osteoporosis
Bone Loss
Age Related
Postmenopausal Bone Loss
Postmenopausal Osteoporosis


Docetaxel Plus Carboplatin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and carboplatin in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
Inclusion criteria: DISEASE CHARACTERISTICS: Histologically confirmed stage IIIB with metastatic pleural effusion or metastatic stage IV non-small cell lung cancer Large cell Adenocarcinoma Squamous cell Bronchioalveolar carcinoma Undifferentiated No small cell or carcinoid histologies At least 1 bidimensionally measurable or evaluable indicator lesion Measurable or evaluable indicator lesion(s) must be completely outside the radiation portal or there must be proof of disease progression No current CNS metastases at study entry No meningeal carcinomatosis

 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT and/or SGPT no greater than 2.5 times ULN if alkaline phosphatase less than ULN, OR alkaline phosphatase no greater than 4 times ULN if SGOT and/or SGPT less than ULN Renal: Creatinine clearance at least 50 mL/min Other: No concurrent illness that would effect assessment of this study Not pregnant or nursing Effective contraception required of all fertile patients

 PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Prior radiotherapy for non-small cell lung cancer allowed Radiotherapy for new brain metastases (other than leptomeningeal disease) is allowed during study, but chemotherapy is stopped during and for 2 weeks following radiotherapy Concurrent radiotherapy to other sites allowed if there is no objective criteria for disease progression Surgery: Not specified Other: No other concurrent experimental drug
Exclusion criteria:


Safety and Efficacy Study of Oral Glycopyrrolate Liquid for the Treatment of Pathologic (Chronic Moderate to Severe) Drooling in Pediatric Patients 3 to 18 Years of Age With Cerebral Palsy or Other Neurologic Conditions

Summary: This is an open-label clinical research study of an oral glycopyrrolate liquid for the treatment of chronic moderate to severe drooling in patients with cerebral palsy or other neurological conditions. Patients participating in the study will receive oral glycopyrrolate liquid (1 mg/5 ml) three times a day (TID) for study duration of 24 weeks. After a washout, screening, and 2-day baseline period, patients will be enrolled in a 4-week dose titration period. Glycopyrrolate liquid doses will be titrated using dose levels in the Dose Titration Schedule. Titration will begin at 0.02 mg/kg per dose TID and sequentially increased in 0.02 mg/kg per dose increments TID every 5-7 days during the first four weeks until optimal individualized response is obtained for each patient or a maximum dose of 0.1 mg/kg TID is reached, not exceeding 3 mg TID or Dose-level 5 in the Dose Titration Schedule, whichever is lesser. Optimal dose for each patient is the dose at which he/she is receiving the maximum benefit from the study drug (greatest improvement in drooling) while experiencing minimum side effects. All patients will receive close attention by study staff throughout the study.
Inclusion criteria: inclusion criteria:

 To be included in this study, patients must meet the following criteria:

 Male or female, weighing at least 13 kilograms (27 pounds), aged 3 through 18 years

 Diagnosis of cerebral palsy and/or mental retardation or any other neurologic impairment or condition (cognitively capable and cognitively impaired patients may be enrolled)

 Chronic drooling in the absence of treatment to the extent that the chin or clothing becomes wet on most days by confirming the Modified Teacher's Drooling Scale score ≥ 5

 Must be living in a situation where reliable parents/caregivers are willing and capable of administering medications, as determined by the investigator

 Written informed consent signed by the parent or legally acceptable representative

 Written assent signed by the age-appropriate patient if mentally capable, as determined by the investigator, and required by the site's Institutional Review Board

 If female of childbearing potential, the patient must have a negative pregnancy test at screening and Visit 2

 If female of childbearing potential and sexually active, she must use a medically acceptable form of contraception

Exclusion criteria: :

 Patients are excluded from this study if they meet any of the following criteria:

 Patients who used glycopyrrolate within approximately 24 hours prior to the start of the baseline period, which began on Day -2

 Patients who used prohibited medications within 5 plasma half-lives of the medication prior to the start of the baseline period

 Patients injected with intrasalivary gland botulinum toxin within 10 months prior to the start of the baseline period

 Patients using intraoral devices or prosthetics for the treatment of drooling within 1 week prior to the start of the baseline period

 Patients receiving acupuncture for the treatment of drooling or who have received acupuncture for the treatment of drooling within 3 months prior to the start of the baseline period

 Patients who have medical conditions contraindicating anticholinergic therapy including gastrointestinal reflux, narrow-angle glaucoma, obstructive uropathy, obstructive disease of the gastrointestinal tract (i.e., delayed gastric emptying, pyloroduodenal stenosis, etc.), paralytic ileus, intestinal atony, vesicoureteral reflux, reactive airway disease, myasthenia gravis, hyperthyroidism, cardiac arrhythmias and/or tachycardia, and/or clinically significant electrocardiogram abnormalities, as determined by the investigator

 Patients who have a known contraindication to the study medication, including allergy to the study medication or any of its components

 Patients who have poorly controlled seizures defined as daily seizures

 Patients who have a history of obstructive disease of the gastrointestinal tract (i.e., intestinal obstruction)

 Patients who have clinically significant hepatic or renal impairment, at the discretion of the investigator

 Patients who are pregnant or breastfeeding

 Patients who have received any investigational drugs within 30 days of study entry

 Patient, families, or parents/caregivers who are expected to be non-compliant with the study procedures, as judged by the investigator

 Patients who are unable to meet the requirements of the study for any reason, as determined by the investigator

 Patients who have unstable mental disease, as determined by the investigator

['Cerebral Palsy', 'Neurological Conditions', 'Mental Retardation', 'Sialorrhea']

Cerebral Palsy
Neurological Conditions
Mental Retardation
Sialorrhea


Maternal Autoimmune Thyroid Disease and Fetal Thyroxin

Summary: The purpose of this trial is to correlate fetal thyroid hormones from fetal cord blood with clinical (maternal antithyroid drug dose and antithyroid antibodies) and ultrasound (US) parameters of fetal thyroid function from pregnant mothers with autoimmune thyroid disease (AITD).
Inclusion criteria: inclusion criteria:

 Autoimmune hyper or hypothyroidism, diagnosed by an endocrinologist, treated, based on clinical and laboratory tests and ultrasound thyroid examination.

 Patients were included if they were seen by gynecologist at Clinic for Gynecology up until 20th week of gestation and not later.

 20 healthy pregnant women in control group were directed for cordocentesis due to age.

Exclusion criteria: :

 Any other chronic diseases.

['Pregnancy Complicated by Hyperthyroidism', 'Hypothyroidism in Pregnancy']


Improving Functional Outcomes in Patients With Unilateral Vocal Cord Paralysis: Assessment of Adaptation Using Functional Magnetic Resonance Imaging

Summary: The purpose of this study is to see how the brain re-learns to control the larynx in speaking and swallowing when undergoing surgical rehabilitation in the form of either thyroplasty or vocal fold augmentation for unilateral vocal cord paralysis. What is needed is information on how the brain re-learns to control speaking and swallowing so that we can eventually learn how to help patients re-learn faster after their procedure. Functional Magnetic Resonance Imaging (or fMRI) will allow us to image your brain as you speak and swallow. We will produce brain maps for speaking, swallowing and hand movements.
Inclusion criteria: inclusion criteria:

 Patients with UVCP undergoing type I thyroplasty or vocal fold augmentation for rehabilitation of speech and swallowing.

 inclusion criteria for the healthy subjects:

 From age 18-85

Exclusion criteria: :

 for the UVCP patients includes the following:

 History of significant psychiatric condition (e.g. schizophrenia, obsessive-compulsive disorder, significant dementia),

 History of the following neurological conditions: CVA, seizure disorders, demyelinating conditions, systemic neuromuscular disorders, cerebral palsy, Alzheimer's disease.

 History of previous moderate to severe traumatic brain injury.

 History of significant cardiovascular, gastrointestinal or renal disease (e.g. myocardial infarction within the previous 12 months, significant vaso-occlusive disease, severe or advanced asthma, or renal compromise)

 History of achalasia

 History of dysphagia, odynophagia, or aphasia unrelated to present illness.

 History of significant claustrophobic reactions.

 Standard contraindications to MR examinations (e.g. implanted stimulators, pregnancy).

['voice evaluation and fMRI', 'undergo voice evaluation and fMRI prior']

voice evaluation and fMRI
undergo voice evaluation and fMRI prior

['Intrathoracic Malignancies', 'Unilateral Vocal Cord Paralysis']

Intrathoracic Malignancies
Unilateral Vocal Cord Paralysis


Randomized Clinical Trial of Polyester vs. Polyurethane Patch for Carotid Endarterectomy

Summary: This study examines the risk of thrombogenicity of the carotid patches in polyurethane compared to carotid patches in polyester including death, any stroke, carotid thrombosis at 30 days and long-term results including stroke and recurrent carotid stenosis at 10 years.~This study was run at the University of Roma, La Sapienza and at the University of Poitiers, randomisation was done in both enters after approval by the Ethical committee of the University of Roma (Record uploaded)
Inclusion criteria: inclusion criteria:

 Carotid stenosis > 60% NASCET criteria

Exclusion criteria: :

 Redo carotid surgery

 Radiation induced carotid stenosis

 Extensive carotid lesion > 5 cm in length with involvement of the common carotid artery best treated by a carotid bypass

['Carotid Artery Thrombosis', 'Carotid Artery Stenosis', 'Stroke']

Carotid Artery Thrombosis
Carotid Artery Stenosis
Stroke


Biomarkers for Diagnosis of Lung Nodules

Summary: A need exists for non-invasive testing to aid in clinical decision-making for Computerized Tomography (CT) scan detected lung nodules of indeterminate etiology. The investigators hypothesize that biomarkers detectable in blood, sputum or urine may be useful for guiding clinical decisions in the setting of CT detected lung nodules to determine which nodules are malignant and which are benign. The investigators also hypothesize that these biomarkers will decrease in concentration to the normal range after successful surgical treatment of malignant lung nodules.
Inclusion criteria: inclusion criteria:

 Adult 18-85 years of age

 Patients referred to pulmonologists, oncologists, or thoracic surgeons for the evaluation of peripheral lung nodules found on CT scan.

 Repeat CT scans, biopsy or surgical excision are clinically indicated to determine the etiology of the nodule.

 One or more lung nodules must be between 8 mm and 30 mm in the greatest diameter.

 Patients must be fully informed of the investigational nature of the procedure and sign an informed consent.

 -

Exclusion criteria: :

 Lung nodules or masses greater than 30 mm in the greatest dimension.

 Lung nodules that have solid calcification.

 Lung nodules or masses with CT evidence of partial or complete obstruction of a lobar bronchus, main stem bronchus or the trachea.

 No prior cancer with the exception of non-melanoma skin cancer.

 Life expectancy of < 6 months

 Any individual who does not give oral and written consent for participation -


Interventional Study of Wellbutrin XL in Major Depressive Disorder With Atypical Features

Summary: The aims of this study are 1) to examine the clinical utility of bupropion hydrochloride extended release (Wellbutrin XL®) in patients with Major Depressive Disorder (MDD) with atypical features; 2) to evaluate the tolerability of bupropion hydrochloride extended release (Wellbutrin XL®) in patients with MDD with atypical features.
Inclusion criteria: inclusion criteria:

 Age over 20 years

 DSM-IV episode of MDD non-psychotic with atypical features characterized by mood reactivity and 2 or more symptoms of vegetative reversal (including overeating, oversleeping, severe fatigue or leaden paralysis, and a history of rejection sensitivity)

 More than 19 score on the 29-item HAM-D

 Ability to give informed consent

Exclusion criteria: :

 Bipolar depression

 Any Axis I psychotic disorder

 A history of suicide attempt, self-injurious action (excluding action with no intention of suicide) or overdosage (excluding apparently accidental overdosage)

 Patients with more than 3-point score of suicide (HAM-D-29 Item 18) or patients whose C-SSRS assessment suggests that they are or have been at significant risk for harming themselves or have actually harmed themselves, or who, in the opinion of the investigator (sub-investigator), are at significant risk for harming self or others

 A history of substance abuse in the previous 12 months

 A history of hypersensitivity to bupropion or any other components of the preparations used in the study (Wellbutrin SR 150mg and Wellbutrin XL 300 mg tablets)

 Serious or unstable medical disorders

 Starting or terminating psychotherapy during the previous 12 weeks,

 ECT treatment in the previous 3 months

 Subject has a life time diagnosis of anorexia nervosa or bulimia within the past 12 month

 Subject has a current or history of seizure disorder or brain injury (traumatic or disease-related) or any condition which predisposes to seizure- subject treated with other medications or treatment regimens that lower seizure threshold- subject undergoing abrupt discontinuation of alcohol or sedatives

 Subjects that previously failed adequate courses of pharmacotherapy from two different classes of antidepressants or previous adequate course(s) of bupropion

 Pregnancy or planning pregnancy - when a patient is in active reproductive age, he or she has to agree to use relevant contraception during the study

 Patients on monoamine oxidase inhibitors (MAOIs)

 Patients being treated with any other preparations containing bupropion as the incidence of seizures is dose dependent


Quality of Life Among Survivors of Hodgkin Lymphoma

Summary: The purpose of this study is to collect information on the long-term side effects of treatment for Hodgkin Lymphoma. We hope to study about 500-800 survivors of Hodgkin Lymphoma. We plan to use the findings from this study to better understand Hodgkin Lymphoma survivors' health and quality of life.
Inclusion criteria: inclusion criteria:

 Biopsy-proven HL Participation in IRB-approved protocols for the first-line treatment of HL between 1975-2000 (IRB #75-104, #75-103, #79-17, #81-103, #90-44, #91-69).

 English speaking

Exclusion criteria: :

 None


Evaluation of an Mhealth Intervention to Increase Adherence to Triage of HPV+ Women

Summary: Cervical cancer remains a serious health problem, particularly in developing countries. It is the leading cause of cancer death among women and mainly affects women of low socioeconomic status.~Evidence has shown that HPV-test self-collection can reduce social and health services barriers to screening and increase coverage. However, high coverage will not result in a decrease of disease burden if women are not diagnosed/treated. The HPV-test indicates whether a woman is positive or not, and a triage test is needed to identify HPV-positive women who need to perform diagnostic procedures. Several triage methods are available. In Argentina, cytology is used as triage method; therefore, all HPV-positive women who have performed self-collection at home need to attend health centers to undergo cytology. However, the proportion of women who have completed triage is low, therefore new innovative strategies are needed to increase attendance to cytology of these women.~This study will be carried out in Jujuy, one of the Argentinian provinces with highest cervical cancer mortality rates and where HPV- self-collection has been introduced as programmatic strategy for screening under-users.~This trial is population-based cluster-randomized study that aims to evaluate the effectiveness of a mHealth intervention versus usual care to increase adherence to cytological triage among women with HPV-positive self-collected tests.~An overall number of 240 Community Health Workers (CHWs) from the Primary Health Care System (PHCS) of the Province of Jujuy will be randomized into two groups:~mHealth Intervention Group: Women with HPV self-collected tests will receive a mixed intervention which includes counseling through an interactive Apps specifically devised to increase adherence to triage which will be run on a tablet, and SMS text messages to remind them to attend triage. In addition, Heads of CHWs, chiefs of gynecology services and CHWs will receive reminders via e-mails and SMS message to contact women if after 60 days from the HPV-results HPV+ they have not performed triage.~Usual Care Group: Women with HPV self-collected tests receive usual care.~A database built specifically for the study will be used; it will include data about randomization Group, agreement to participate in the study and socio-demographic data. Data on HPV-testing and triage will be uploaded importing the data from SITAM, using the Unique Identification Number (DNI).~Data Analysis~Effectiveness to enhance adherence to cytological triage: Adherence to triage will be considered for each CHW. This will be defined as the number of women with triage smears within 30, 60 and 90 days. There will be a comparison of the percentage of HPV-positive women that did the Pap test within those time intervals in the mHealth intervention group and the Usual Care group. The effect of the mHealth intervention against usual care will be estimated using a means difference test or a non-parametric test for independent samples.
Inclusion criteria: inclusion criteria:

 Women 30 years and older living in a household visited by Community Health Workers (CHWs).

Exclusion criteria: :

 Women with a previous HPV test.

 Women with precancerous lesion or cervical cancer.

 Current pregnancy.

 Women with Mental disability.


The Prognostic Value of FDG PET/CT and Diffusion-weighed Imaging on Breast Cancer

Summary: The purpose of this study is to determine findings of positron emission tomography and diffusion weighted magnetic resonance in primary lesion and axillary metastasis of breast cancer and compare of two imaging modality in these patients.
Inclusion criteria: inclusion criteria:

 Newly diagnosis of breast cancer for which surgical intervention is planned

Exclusion criteria: :

 patients received neoadjuvant chemotherapy

 before breast surgery


Human Papillomavirus (HPV) Testing to Improve Cervical Cancer Screening in the Mississippi Delta

Summary: Background:~Cancer of the cervix (bottom third of the uterus, or womb) can be prevented by regular Pap tests (also called Pap smears), which check for changes in the cells of the cervix. Because many women in the United States have regular Pap smears, cervical cancer is not common in this country. However, the disease is common among women in the Mississippi Delta because of poor participation in screening programs.~The major causes of cervical cancer are persistent human papillomaviruses (HPV) infection by cancer-associated HPV types and lack of screening. These viruses cause an infection that often goes away by itself, but if it does not go away, over a long time lead to cervical cancer. HPV causes cervical abnormalities, which are detected by Pap smears and then treated.~Objectives:~-To determine whether an at-home self-collection method for obtaining cells from the cervix can be a simple, safe and inexpensive way to screen for cervical cancer for women who don t go to the health clinic regularly.~Eligibility:~Women who reside in the counties of Leflore, Sunflower, Washington or Tallahatchie, Mississippi.~Women between 26 and 65 years of age who are not pregnant and who have not had a hysterectomy.~Design:~Screening study participants undergo the following:~The doctor takes a cervical sample using the same self-collection device that women will use at home to self-collect.~Pelvic examination and Pap test. For this test, the woman lies on an exam table and the doctor inserts an instrument called a speculum into the vagina, opening it to see the cervix. A special brush is used to take a few cells from the cervix. The cells are placed on a glass slide and sent to a lab for examination.~Cervical cell specimen collection using an at-home self-collection kit that participants will use at home after 2 weeks~At-home self-collection by participant after 2 weeks.~Referral to a doctor for follow-up care, if needed.~Colposcopy (see below) in all women with a Pap test that is abnormal or positive for HPV and for some women with a normal smear.~Colposcopy study participants undergo the following:~The doctor takes a cervical sample using the same self-collection device that women will use at home to self-collect.~Colposcopy, an exam in which the doctor examines the cervix using a light and looks through a magnifying device to see if there is any abnormal tissue on the cervix. During this exam, the doctor may remove a small sample of tissue to diagnose any abnormality. Participants also have a sample collected using the self-collection kit.~At-home cervical sample collection by participant after 2 weeks.~Notification if further medical care is required and treatment if the biopsy looks abnormal.
Inclusion criteria: inclusion criteria:

 Five-hundred women attending colposcopy and 500 women receiving cytology screening, including 250 unscreened women, will be recruited for the study. Non-pregnant, non-hysterectomized women aged 26-65 will be recruited.

Exclusion criteria: :

 Women under 26 or over 65 years of age.

 Pregnant women or women having given birth to a child in the past 8 weeks. To insure women included in the study are not pregnant, we will ask women during the consenting process if they are pregnant. Women who answer yes for either query will be excluded. Participants will also receive a reminder call for their 2-week self-collection. At that time, women again will be asked if they are pregnant. If any woman answers yes, she will be instructed to not self-collect.

 Women who have had a total hysterectomy.

 Women who have an overt cancerous lesion visible upon exam by the clinician.

 Other reasons to exclude women include the inability to speak English, the appearance of mental incompetence, or refusal to participate or sign the informed consent form.


Asthma Severity in Children and Environmental Agents

Summary: This study measures residential exposures (indoor allergens, mold, nitrogen dioxide, nicotine) and relates exposure levels to daily symptoms (wheeze, persistent cough, chest tightness, shortness of breath) and medication use, in a population of children with physician diagnosed asthma, followed for 12 months.
Inclusion criteria: Siblings of a birth cohort recruited 1997-1999

 Age less than 11 years

 Physician diagnosed asthma

 Active symptoms (wheeze, persistent cough, chest tightness, shortness of breath) or medication use in the 12 months prior to enrollment.
Exclusion criteria:


Treatment in Patients Hospitalized With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Summary: Chronic obstructive pulmonary disease has become a serious global health care and public health problems due to its high prevalence, high morbidity and heavy economic burden. Acute exacerbation of chronic obstructive pulmonary disease is one of the most important causes of death in patients with COPD. Systemic corticosteroids therapy is recommended in COPD exacerbations. In clinical practice for the treatment of acute exacerbation of COPD， antibiotic application is still controversial. Evidence from current guideline is based on strict criteria from randomized controlled trials, thus the given condition is simplified. Patients meet the criteria account for the minority in the real world. Therefore, it is still not clear whether most patients benefit from the recommended treatment. In our design, hospitalized patients with acute exacerbation of COPD will be enrolled, with their treatment, arterial hypoxemia, recovery time and length of hospitalization being observed. The main purpose is to evaluate the benefit effect of current recommended treatment of acute exacerbation of COPD in the real world.
Inclusion criteria: inclusion criteria:

 Hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease

 Age≥ 40years old

Exclusion criteria: :

 The first diagnosis which caused hospitalization is not acute exacerbation of chronic obstructive pulmonary disease

 Chest radiography shows congestive heart failure

 Chest CT shows lung cancer, active pulmonary tuberculosis, pulmonary thromboembolism or interstitial lung diseases

 Serious cardiac failure, renal insufficiency or hepatic dysfunction

['Chronic Obstructive Pulmonary Disease']


Use of Ceftaroline in Hospitalized Patients With Community Acquired Pneumonia

Summary: Community-acquired bacterial pneumonia, which is often called CAP, is a bacterial infection in the lungs and is treated with antibiotics. Sometimes people need to be in the hospital to be treated for CAP. Usually, hospitalized persons with CAP are given two antibiotics together. These antibiotics usually include a cephalosporin and a macrolide. The most commonly used cephalosporin at Albany Medical Center Hospital is ceftriaxone. The most commonly used macrolides at Albany Medical Center Hospital are azithromycin and doxycycline.~This research is being done to find out how well a new cephalosporin antibiotic, called ceftaroline, works in combination with a macrolide for the treatment of CAP. Ceftaroline is similar to ceftriaxone. Ceftaroline was recently approved by the FDA to treat pneumonia in hospitalized patients based on two research studies. In one study, ceftaroline was better than ceftriaxone. In the second study, ceftaroline was just as good as ceftriaxone. Ceftaroline was very well tolerated in both clinical studies and it was found to be as safe as ceftriaxone.
Inclusion criteria: inclusion criteria:

 age 18 years or older

 met ATS/ISDA criteria rule of CABP

 CABP requiring hospitalization and treatment with a IV antimicrobial

 anticipated hospitalization for > 48 hours

 received ceftaroline in combination with a macrolide (clarithromycin, or azithromycin) for > 48 hours within the first 24 hours after presentation to the hospital and must have remained on therapy for at least 48 hours after admission

 Pneumonia Patient Outcomes Research Team (PORT)risk class III or IV

Exclusion criteria: :

 CABP PORT Risk class I, II, III

 CABP requiring admission to an ICU

 CABP suitable for outpatient therapy with an oral microbial agent

 confirmed or suspected respiratory tract infection attributed to a source other than CABP pathogens

 noninfectious case of pulmonary infiltrates or pleural empyema

 infection with a pathogen know to be resistant to ceftaroline or epidemiological/ clinical context suggesting a high likelihood of a resistant pathogen

 previous therapy with another intravenous beta-lactam for CABP for between 24 and 96 hours prior to randomization

 receipt of chronic concomitant systemic steroids > 40 mg of prednisone equivalent

 significant hepatic disease

 hematologic disease

 Immunological disease

 history of a hypersensitivity reaction to beta-lactams

 pregnant or nursing females

['Community Acquired Bacterial Pneumonia']


Nutritional Evaluation of Patients With Congestive Heart Failure

Summary: This study objective is to assess the nutritional status of Patients With Congestive Heart Failure.
Inclusion criteria: inclusion criteria:

 Congestive heart failure patients between tne ages 40 to 90,all stages of the disease.

Exclusion criteria: :

 non


A Trial to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin® Compared to Genexol® Plus Carboplatin® as a Firstline Treatment in Subjects With Ovarian Cancer

Summary: The purpose of this study is to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin® Compared to Genexol® Plus Carboplatin® as a Firstline Treatment in Subjects With Ovarian Cancer.
Inclusion criteria: inclusion criteria:

 Subjects who aged 18 years or older

 Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial

 Subjects who have histologically or cytologically confirmed unresectable or metastatic epithelial cancer of the exocrine pancreas. High-quality contrast-enhanced CT scanning is required to evaluate resectability. Measurable disease is not required.

Exclusion criteria: :

 Subjects who have received prior radiation therapy (XRT) for pancreatic cancer unless progression was documented after XRT and 6 weeks have elapsed between completion of XRT and start of trial medication.

 Subjects who have had systemic treatment such as chemotherapy or immunotherapy, for pancreatic cancer. However, prior use of chemotherapy, e.g. 5-FU or capecitabine, for radiation sensitization is allowed. If gemcitabine was given in the adjuvant setting, only subjects relapsed with cancer after 6 months of completing the last dose of gemcitabine can participate in the trial.

 Subjects who have had a major surgery within 2 weeks prior to the screening/baseline visit

['Genexol®-PM 260mg/m2 plus Carboplatin 5 AUC', 'Genexol® 175mg/m2 plus Carboplatin 5 AUC']


Quantifying Lung Tumor Movement Under Deep Inspiration Breath Holds

Summary: Radiotherapy is a common treatment for lung cancer. One Challenge of delivering radiation treatment to lung tumors accurately is tumor movement which occurs as a patient breathes. In some situations, tumors move enough during breathing so that some or all of the tumor may be missed by a radiation treatment. One way to decrease the amount a lung tumor moves during radiotherapy treatments is for patients to held their breath briefly during a radiation treatment. By doing this, a patient's lung tumor may not move as much as it would during regular breathing. In this study, the investigators aim to study patients with lung cancers which move during breathing. Patients will be asked to hold their breath after inspiration while a CT scan of their lung tumor is obtained. The purpose of this study is to study how much less patients' lung tumors move when they hold their breath
Inclusion criteria: inclusion criteria:

 biopsy confirmed primary lung cancer

 undergoing radiotherapy or chemoradiotherapy

 able to perform adequate deep inspiration breath hold

 patients of childbearing potential must practice adequate contraception

 signed study-specific informed consent form

Exclusion criteria: :

 unable to perform adequate deep inspiration breath hold

 prior tumor resection

 prior chest or neck RT

 pregnant

['CT scan of the chest under deep inspiration breath hold']


Randomized Clinical Trial on Clinical Management of ASCUS and LSIL (ALTS)

Summary: Approximately 65 million Pap smears are performed each year in the United States. The vast majority of results are negative (no abnormality identified) but about 5 percent to 8 percent are reported as abnormal. Most low-grade changes regress spontaneously; only a minority of such lesions would progress to a cancer precursor without treatment. However, there is no way to determine morphologically which patients are at risk or progression. Therefore, both high- and low-grade lesions were often managed with colposcopy and directed biopsy.~Epidemiologic, virologic and molecular studies have clearly demonstrated that human papillomavirus (HPV) is the central cause of cervical cancer. The motivation for the Atypical squamous cells of undetermined significance (ASCUS)- Low grade squamous intraepithelial lesion (LSIL) Triage Study (ALTS) trial was to use the information we have gained about the role of HPV to design better treatment and prevention strategies to reduce the burden of cervical cancer and its precursors.~ALTS consisted of three management strategies: (1) immediate colposcopy of all women; (2) repeat cytology with colposcopy only if the results show a high grade lesion; and (3) HPV testing and repeat cytology in combination, with referral to colposcopy if either the HPV test is positive or the cytology shows a high grade lesion. Four Clinical Centers University of Alabama, Birmingham Alabama (AL); Magee-Womens Hospital, Pittsburgh Pennsylvania (PA); University of Oklahoma, Oklahoma City OK; and University of Washington, Seattle Washington (WA) enrolled approximately 5,000 women with recent diagnosis of ASCUS or LSIL. Participants were followed at six month intervals for a total of 2 years.~The ALTS database and ALTS specimens continue to be a valuable research resource in studies of cervical cancer precursors, screening tests, visual assessment of the cervix and investigation of biomarkers.
Inclusion criteria: inclusion criteria:

 Diagnosis of atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesion (LSIL)

 18 years or older

 Able to give informed consent with reasonable likelihood of follow-up

Exclusion criteria: :

 Previous Hysterectomy

 History of excisional or ablative treatment of cervix, such as laser treatment, radiation therapy, cauterization (burning), freezing or surgery such as cone biopsy or loop electrosurgical excision procedure (LEEP).

 Already known to be pregnant

 Already known to be human immunodeficiency virus (HIV) positive (HIV may negatively affect the clinical history of human papillomavirus (HPV), making triage less appropriate.

['Thinprep', 'Hybrid capture 2', 'Colposcopy']


Safety and Performance Study of Large Hole Vascular Closure Device

Summary: The purpose of this Clinical Investigation is to validate that the clinical use of the VIVASURE CLOSURE DEVICE™ is safe for the operator, patient and third parties, and to confirm its performance to percutaneously close femoral arterial puncture sites in the range of 18-24 F, post endovascular procedures.~This is a non-inferiority study based on safety. Safety will be assessed by incidence and severity of major complication rates directly related to the VIVASURE CLOSURE DEVICE™ up to 3 months from implantation is no worse than those associated with cut-down and sutured close.
Inclusion criteria: inclusion criteria:

 Over 18 years of age

 Each patient, or his or her guardian or legal representative, is willing to give informed consent

 Clinically indicated for an endovascular procedure involving access through the femoral artery, with an access puncture of 18 - 24 French (F)

 Females who are not pregnant or lactating, and not planning to become pregnant in ≤ 12 months

Exclusion criteria: :

 Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than one year

 Evidence of systemic bacterial or cutaneous infection

 Evidence of MRSA (Methicillin-resistant Staphylococcus aureus) and/or VRE (vancomycin-resistant Enterococci) colonisation

 Arterial access other than the common femoral artery

 Patients suffering with definitive or potential coagulopathy or platelet count less than 100,000/μl

 Patient with a haematocrit of less than 32 %

 A measured activated clotting time (ACT) of greater than 350 seconds immediately prior to sheath removal

 If patients are expected to be continuously treated with anticoagulation therapy post-procedure such that their ACT reading is expected to be elevated above 350 seconds for more than 24 hours after the procedure

 Evidence of arterial diameter stenosis greater than 20 % within 20 mm of the arteriotomy

 Circumferential calcification within 20 mm of the arteriotomy

 Use of systemic thrombolytic agents within 24 hours prior to or during the catheterisation procedure which cause the concentration of fibrinogen to be less than 100 mg/dl

 Patients in which the arteriotomy is less than 18 F or greater than 24 F

 Known allergy to any of the materials used in the device

 Currently enrolled in any other investigational clinical study, whereby the primary endpoint has not yet been achieved

 Patients judged unsuitable for surgical repair of the access site

 If puncture site is via a vascular graft

 If there is any indication that the puncture has been made in the profunda femoris or located less than 10 mm above the profunda femoris

 Patients with a common femoral artery lumen diameter of less than 7 mm

 Patients that have a lower extremity amputation from the ipsilateral or contralateral limb

 Patients that have undergone a percutaneous procedure using a non-absorbable vascular closure device (excluding suture mediated) for haemostasis in the ipsilateral leg

 Patients that have undergone a percutaneous procedure greater than 8 F in the ipsilateral leg, within the previous 90 days

 Patients that have undergone a percutaneous procedure of 8 F or less using an absorbable intravascular closure device for haemostasis, in the ipsilateral leg, within the previous 90 days

 Patients that have undergone a percutaneous procedure of 8 F or less using a suture mediated closure device for haemostasis, in the ipsilateral leg, within the previous 30 days

 Patients that have undergone a percutaneous procedure of 8 F or less using manual/mechanical pressure for haemostasis in the ipsilateral leg, within the previous 30 days

 Patients with an acute haematoma of any size, arteriovenous fistula or Pseudoaneurysm at the access site

 Significant blood loss/transfusion during interventional procedure or within 20 days of procedure requiring transfusion of greater than 4 units of blood

 Angiographic evidence of arterial laceration, dissection or stenosis within the external iliac or femoral artery before the use of the VCD

 Severe claudication, stenosis of the iliac artery > 50% or previous bypass surgery/stent placement in the region of the vascular access

['Percutaneous Common Femoral Artery Arteriotomy Closure']


Immune Response in Adults to PrEP and Simulated Booster PEP With a New CPRV

Summary: Pre exposure rabies vaccination with a new Chromatographically Purified Vero-cell Rabies Vaccine(SPEEDA) is as effective as Purified Vero-cell Rabies vaccine.~After the pre exposure rabies vaccination with a new Chromatographically Purified Vero-cell Rabies Vaccine(SPEEDA), the Rabies neutralizing antibodies in all patients on day 42 are 0.5 IU/ml or more.~And Simulated post-exposure rabies booster vaccination with a new Chromatographically Purified Vero-cell Rabies Vaccine(SPEEDA) is as effective as Purified Vero-cell Rabies vaccine.~After the simulated post-exposure rabies booster vaccination with a new Chromatographically Purified Vero-cell Rabies Vaccine(SPEEDA), the Rabies neutralizing antibodies in all patients on day 14 after the booster are 0.5 IU/ml or more.
Inclusion criteria: inclusion criteria:

 Healthy

 Can visit according to the protocol

Exclusion criteria: :

 Fever

 Acute illness

 History of rabies vaccination

 Allergic to the vaccines' component

 Immunosuppressive conditions such as HIV infection, transplantation, chronic renal failure, received steroid or immunosuppressive drugs and anti-malarial drugs within previous two months or any blood products within previous three months

 Female participant must not be pregnant

 All female participant must have urine pregnancy test negative prior to participate the study

['New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).']


Implantation of Markers for the Radiotherapy of Lung Cancer Patients

Summary: This clinical trial studies imaging markers in planning radiation therapy in patients with lung cancer. Implanting markers in the tumor that can be seen using imaging procedures during radiation therapy may allow x-rays to be sent directly to the tumor and cause less damage to normal tissue.
Inclusion criteria: DISEASE CHARACTERISTICS:

 Diagnosis of non-small cell lung cancer

 Stage I-IIIB disease

 No prior surgical tumor resection

 Respiration-induced tumor motion > 5 mm

 Recruited by attending physician or research nurse at the Medical College of Virginia Hospitals

 PATIENT CHARACTERISTICS:

 Not pregnant

 No insufficient lung function or other parameters prohibiting a bronchoscopy

 Not a prisoner or institutionalized

 PRIOR CONCURRENT THERAPY:

 See Disease Characteristics

 Concurrent chemotherapy allowed
Exclusion criteria:

['radiation therapy treatment planning/simulation', 'implanted fiducial-based imaging']