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Objective This investigation will focus on two areas: 1) early communication impairments as predictors of autism spectrum disorder (ASD) and later developmental delays, and 2) the relationship between communication and evidence of CNS function (sleep, EEG) and structure (MRI DTI and volumetrics) in young children at risk for ASD. The objective is to delineate early communicative impairments that predict ASD vs. other developmental delays and to examine how these impairments correlate with brain abnormalities in both structure and function. Study Population We will recruit 64 children [n=32 at 12 months of age (plus or minus 2 months); n=32 at 18 months of age (plus or minus 2 months)] who are at-risk for ASD due to communication/language delays (at-risk group). The at-risk children will be matched at initial on chronological age, SES, and sex, to typically developing children (n=75) with no history of developmental delays. These 139 participants will hereafter be referred to as the toddler sample. At the 36 month final visit, diagnostic status (e.g. ASD, non-ASD specific delays, catch up) will be determined for children in the at-risk group. In addition, 10 healthy adults, aged 18-40 will serve as control participants for the purpose of piloting the functional paradigms for the MRI portion of the protocol. Design We propose to conduct a prospective, longitudinal study of toddlers at-risk for ASD compared to typically developing toddlers. Children will complete behavioral testing and an overnight Sleep/EEG as well as MRI at either a 12 or 18 month initial. Follow-up visits that include behavioral assessment will occur at 24 and 36 months for all children (and at 18 months of age for the 12-month cohort). The Sleep/EEG and MRI will be repeated at the 36 month final follow-up. Outcome Measures Autism symptoms, language status, and cognitive development at 36 months will serve as the primary outcome measures. The purpose of this study is to learn more about risk factors for autism by studying the behavior and brain functioning of toddlers with early communication delays and typically developing toddlers. Children 12 or 18 months of age with language delays (i.e., no words at 18 months, limited vocalizations at 12 months) and typically developing toddlers may be eligible to participate. This study will be conducted at the NIH Clinical Center in Bethesda, Maryland. There will be an initial screening evaluation that will include behavioral assessment. Eligible participants will then complete a baseline visit that includes an overnight sleep study that includes Electroencephalogram (EEG) test to measure brain electrical activity, and an MRI scan. Follow-up visits that include behavioral assessment will occur every 6-12 months, depending on age at study entry. The final study visit will occur at 36 months of age and will include behavioral assessment, sleep/EEG study, and MRI. There is no cost for participation. Compensation will be provided. To find out if your child qualifies or for more information, please call 301-451-7822 (TTY: 1-866-411-1010) or e-mail NIMH-ASD@mail.nih.gov. National Institute of Mental Health, National Institutes of Health, Department of Health & Human Services....

Our University of Chicago Crime Lab research team will carry out a 2 x 2 randomized experiment, in which some male youth are randomly assigned to receive what we believe to be best-practice intensive academic supports (high-dosage math tutoring provided by Match Education of Boston), or what we believe to be best-practice non-academic supports, for which we have identified Youth Guidance's Becoming a Man (BAM) program that provides a version of cognitive behavioral therapy (CBT), or to receive both, or neither (control condition). At the time the program is being launched, our research team has resources to provide intervention services to youth for one year (AY 2013-14). Our team is currently seeking additional funding to be able to provide youth randomized into different treatment and control conditions with 2 years of intervention. The BAM intervention is a version of CBT adapted to help promote pro-social life outcomes among disadvantaged male youth. BAM includes in-school and after school programming designed to reduce overly-automatic behavior that can lead to problem outcomes, encourage youth to reflect on their decision-making heuristics, or promote meta-cognition (to "think about thinking"). By helping youth learn and practice new ways to manage their emotional responses to difficult situations through stories, role-playing, small group exercises, and homework, the program encourages what psychologists call "cognitive restructuring," designed to generate lasting gains in youths' behaviors. BAM is a program of Youth Guidance (YG), a Chicago-area non-profit that has been serving Chicago children for 87 years, and currently provides services to 14,000 at-risk students across more than 70 schools through a partnership with the Chicago Public Schools (CPS) that dates back more than four decades. YG will implement the BAM intervention beginning in the 2013-14 academic year in some of the most distressed schools in Chicago's south and west sides. The Match Tutors program expands on the nationally recognized innovation of high-dosage, in-school-day tutoring developed in the three Match Charter Public Schools in Boston. Tutoring is embedded into the school day as an elective class, as a supplement to the regular classroom math teacher. Every student works with a full-time, professional tutor in addition to their other classes, so that the class offered by Match Tutors will be given for credit, not as a pull-out or after school intervention As a regular part of their school day, students will attend tutoring for 50 minutes a day, 5 days a week. The tutoring course, entitled Mathematics Lab, has been granted credit-bearing status by CPS and will be offered each semester within a school year so that students will earn one elective credit upon completion of the course. Math Lab offers a standards-based curriculum that is individualized to each student's needs with the goal of complementing the work done in math classes - preparing students for city and state math assessments, enabling them to pass math class finals, and helping students build skills and habits of learning that will help them succeed in school and beyond. The purpose of this study is to learn more about the most cost-effective way to improve the long-term life outcomes of disadvantaged youth, by comparing best practice academic supports to best-practice non-academic supports, and learning more about whether investing in both simultaneously has synergistic (more than additive) effects.

As the number of patients requiring organ transplants continues to increase, the number of organs available from deceased donors cannot meet demands. Beginning in the early 1990s, organs from living donors became a widely-available option, increasing the number of available organs for transplant. However, because organ donation has the potential to adversely affect a living donor's health, long-term studies to determine the effect of donation on these donors are needed. The purpose of this study is to determine the mortality, the early postoperative morbidity, and the occurrence of end stage lung disease for participants who underwent donor lobectomy between 1993 and 2006. Participants in this study will have had donor lobectomy at the University of Southern California in Los Angeles or the Washington University Medical Center and Barnes-Jewish Hospital in St. Louis. There will be no study visits for retrospective cohort study. Investigators will collect data from existing medical records and databases. The use of live donors for solid organ transplantation has increased the number of available organs for those waiting for a transplant. Donation of an organ may have significant effects on a donor's health. This study will determine the baseline characteristics, early postoperative morbidity, and long-term survival for participants who underwent donor lobectomy between 1993 and 2006.

There are subgroups of patients who only seek care in emergency settings. An effective strategy to link that group to ambulatory care involves extending contact with psychiatric emergency services beyond the initial hospital-based visit. The "window of opportunity" to promote successful treatment linkage is brief. This is a study of a novel treatment format that seeks to expand the concept of the emergency contact, the study patients method of entering the mental health system of care, and by doing this, enhance retention in prescribed outpatient care. The effects of the intervention on patient symptoms and mental health service use will be examined. The purpose of this study is to compare two different kinds of follow-up care and their effects on psychiatric service use and psychological well-being. This randomized, controlled trial of subjects discharged from the psychiatric emergency services to outpatient care receive traditional hospital-based outpatient clinic referrals (treatment as usual) or appointments for community-based follow-up by a mobile crisis team.

This is a multicentre prospective randomised controlled trial to determine whether a reduction of body temperature by 3-4°C following perinatal asphyxia improves survival without neurodevelopmental disability. Full term infants will be randomised within 6 hours of birth to either a control group with the rectal temperature kept at 37 ± 0.2°C or to whole body cooling with the rectal temperature kept at 33.5 ± 0.5°C for 72 hours followed by slow rewarming. The outcome will be assessed at 18 months of age by survival and neurological and neurodevelopmental testing. Eligibility criteria: Term infants less than 6 hours after birth with moderate or severe perinatal asphyxia (a combination of clinical and EEG criteria). Exclusion criteria: Infants expected to be 6 hours of age at the time of randomisation or infants with major congenital abnormalities. Intervention: Intensive care with whole body cooling versus intensive care without whole body cooling (babies are cooled to 33.5°C for 72 hours) Main Outcomes: Death and severe neurodevelopmental impairment at 18 months of age Secondary Outcomes: Cerebral thrombosis or haemorrhage, persistent hypotension, pulmonary hypertension, abnormal coagulation, arrhythmia and sepsis in the neonatal period. Neurological impairments at 18 months Number of patients required: 236. On 30th November 2006, when recruitment closed, 325 babies had been recruited. Hypothesis: Prolonged whole body cooling in term infants with perinatal asphyxial encephalopathy reduces death and severe neurodevelopmental disability. This study aims to determine whether whole body cooling to 33-34°C is a safe treatment that improves survival, without severe neurological or neurodevelopmental impairments at 18 months, of term infants suffering perinatal asphyxial encephalopathy.

The human prion diseases have been traditionally classified into Creutzfeldt-Jakob disease (CJD), Gerstmann-Sträussler-Scheinker (GSS) disease and kuru. They can alternatively be classified into three causal categories: sporadic, acquired and inherited. The appearance of a new human prion disease, variant CJD (vCJD), in the United Kingdom from 1995 onwards, and the experimental evidence that this is caused by the same prion strain as that causing bovine spongiform encephalopathy (BSE) in cattle, has raised the possibility that a major epidemic of vCJD will occur in the United Kingdom and other countries as a result of dietary or other exposure to BSE prions. These concerns have led to intensified efforts to develop therapeutic interventions. Quinacrine has been previously used to treat other diseases such as malaria; however, it was found to have serious side effects and is no longer licensed in the United Kingdom. There is only very limited evidence from laboratory tests for the potential use of quinacrine in human prion disease, and the evidence to date for any possible clinical benefit is very scarce. The PRION-1 trial is being undertaken since there are no other drugs currently available which are considered suitable for human evaluation. PRION-1 aims to assess the activity and safety of Quinacrine (Mepacrine hydrochloride) in human prion disease. It also aims to establish an appropriate framework for the clinical assessment of therapeutic options for human prion disease that can be refined or expanded in the future, as new agents become available.

OBJECTIVES: - To assess survival of patients with localized prostate cancer at 10 years and 15 years after treatment. - To investigate disease progression (i.e., biochemical and clinical), treatment complications, and lower urinary tract symptoms in these patients. - To investigate the psychosocial impact of cancer detection and treatment on these patients, including generic health status, quality of life, and sexual function. - To estimate the resource use and costs of detection, treatment, and follow-up. - To compare costs and outcomes of treatment in terms of survival and health-related quality of life. - To collect samples suitable for basic science research (ProMPT study). OUTLINE: This is a multicenter study. Patients are stratified by age (50-55 vs 56-59 vs 60-65 vs 66-69 years), Gleason score (6, 7, 8-10), and average result of recruitment and first biopsy prostate-specific antigen (PSA) tests (< 6 vs 6-9.9 vs ≥ 10 ng/mL). Patients are randomized or select a treatment to be followed up in a cohort study. RATIONALE: Radical prostatectomy is surgery to remove the entire prostate. Radiation therapy uses high-energy x-rays or other types of radiation to kill tumor cells. Sometimes the tumor may not need treatment until it progresses. In this case, active surveillance may be sufficient. It is not yet known which treatment regimen is more effective for localized prostate cancer. PURPOSE: This randomized phase III trial is studying active monitoring to see how well it works compared with radical prostatectomy or radiation therapy in treating patients with localized prostate cancer.

Textbooks and expert opinion recommend both diazepam and lorazepam as initial therapy for children in status epilepticus (SE) and provide recommended doses that are commonly used. However, unlike diazepam, lorazepam is only FDA-approved for treatment for SE in patients over 18 years of age. Despite this fact, many experts support the use of lorazepam over diazepam in pediatric SE. Increased duration of action, increased effectiveness in terminating SE, and a lower incidence of respiratory depression have been cited as potential advantages of lorazepam over diazepam. However, data to support firm recommendations for one medication over another are lacking. Thus, either diazepam (FDA-approved) or lorazepam can be considered first-line agents for pediatric SE, and the physician's choice of agent depends on local practice patterns and individual treatment styles. In the prehospital (Emergency Medical Services) setting, diazepam is commonly chosen because of a longer shelf life without refrigeration. The purpose of this study is to determine the differences in efficacy and safety between these two commonly used benzodiazepines, as requested by the FDA under the Best Pharmaceuticals for Children Act, using the Exception from Informed Consent provided by the FDA. Children with seizures are frequently seen in the emergency department. The drug lorazepam, which is commonly used, is not labeled by the US Food and Drug Administration for children for this use. The FDA, under the Best Pharmaceuticals for Children Act, has requested that a study comparing diazepam, a drug that is labeled by the FDA for this indication, with lorazepam be performed. The study will show whether one drug is more effective and safe than the other.

Fish oils have many proven benefits for a wide range of clinical arenas such as ischaemic heart disease, rheumatoid arthritis and inflammatory bowel disease. Recent research has described the beneficial effects of intravenous fish oils for surgical patients, such as reduced hospital stay, reduced re-operation rate and reduced requirements for intravenous antibiotics. These are in part due to the anti-inflammatory effects of fish oils. There is evidence that fish oils are also effective against cancer, large population studies indicate that diets rich in omega-3 are associated with a lower incidence of cancer, and in vitro and animal studies demonstrate anti-tumour effects of fish oils 1. Fish oils inhibit the growth of different human cancer cell lines 2. They act specifically on tumour cells only and do not impair the function of normal cells 3. EPA and DHA inhibit the growth of human cancer cell lines and enhance apoptosis. 4. Fish oil induces apoptosis in human colorectal cancer cell lines in-vitro after 48hrs incubation 5. Fish oil has been shown to inhibit the proliferation activities, inhibit the invasive activities and increase the apoptosis of human pancreatic carcinoma cell lines in-vitro after only 48hrs of exposure 6. Fish oil has been shown to enhance colorectal adenocarcinoma cell lines sensitivity to radiotherapy 7. Fish oil has also been shown to reduce the incidence of liver metastases in experimentally induced ductal pancreatic cancer in rats after 30 weeks of oral treatment with an omega-3 supplemented diet. 8. Lung cancer xenografts in animals fed with fish oil showed significantly increased tumour regression in response to doxorubicin compared to those fed with omega-3. This study aims to assess the effect of omega-3 FA upon hepatic colorectal metastases in a pilot study. 20 patients will be selected for this pilot study with potentially resectable hepatic colorectal adenocarcinoma metastases. 10 patients will receive total parenteral nutrition (TPN) without fish oils (controls), 10 will receive fish oil containing lipid emulsion in their TPN. Changes in tumour angiogenesis (increased angiogenesis is associated with a poorer prognosis in hepatic colorectal metastases) will be investigated using digital contrast enhanced MRI scanning, and markers of angiogenesis will be investigated in blood and resected tumour samples from the patients. It is a randomised controlled double blind trial. The purpose of this study is to determine whether fish oils - a known source of omega-3 given intravenously (via a 'drip') will help cure secondary deposits in the liver from bowel cancer.

To compare the efficacy and safety of a select serotonin re-uptake inhibitor (SSRI, sertraline) and a tricyclic antidepressant (TCA, nortriptyline) in outpatients over the age of 60 who meet Diagnostic and Statistical Manuel-IV criteria for unipolar major depression, excluding patients who meet criteria for psychotic or atypical subtype. To test the hypothesis that medication condition interacts with diagnostic subtype (melancholic vs non-melancholic) in determining antidepressant response. To examine the roles of symptom severity and alternative diagnostic subtyping in contributing to this pattern. SSRIs are effective in the treatment of major depression. However, there is also evidence that SSRIs may be significantly less effective than TCAs for depressed patients with melancholia. This issue is of particular concern in late-life major depression. SSRIs have important safety advantages with respect to overdose and a benign cardiovascular profile. Furthermore, the SSRIs do not have significant anticholinergic effects, and appear to be better tolerated than the TCAs. Perhaps most important, the SSRIs currently are prescribed widely as the medication treatment of first choice for major depression in late life. Therefore, if it were determined that SSRIs are considerably less effective than TCAs in the treatment of melancholia in the elderly, there would be significant ramifications for clinical practice. Randomization to sertraline (a SSRI) or nortriptyline (a TCA) is stratified by the presence or absence of melancholia. Outcome measures for the 12-week acute phase include clinician and patient ratings of symptoms, side effects, and an evaluation of the health-related quality of life (HRQOL). At the end of the acute treatment phase, patients who meet criteria for clinical response participate in a 6-month continuation phase. The purpose of this study is to compare the safety and effectiveness of a select serotonin re-uptake inhibitor (SSRI, sertraline) and a tricyclic antidepressant (TCA, nortriptyline) in outpatients over the age of 60 who have major depression. SSRIs are effective in the treatment of major depression. However, there is also evidence that SSRIs may be significantly less effective than TCAs for patients with late-life major depression with melancholia. Since SSRIs seem to be easier to take than TCAs and are more widely prescribed, it is important to determine which of these types of antidepressants works best to treat these patients. Patients will be assigned randomly to receive either sertraline (a SSRI) or nortriptyline (a TCA) for 12 weeks. Patients will be monitored for symptoms, side effects, and quality of life. If a patient responds to treatment, he/she will participate in a 6-month continuation phase in which he/she will continue to receive the same medication. An individual may be eligible for this study if he/she: Has unipolar major depression (with some exceptions) and is over 60 years old.