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NCT ID: NCT01905605 Withdrawn - Schizophrenia Clinical Trials

Phosphatidylcholine Supplementation in Infants

Start date: September 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Sensory gating is defined as the automatic process of inhibiting brain response to repeated auditory sounds. Infants who brains respond similarly to two identical sounds presented about 1/2 second apart are more likely to have later problems with attention than infants who suppress response to the second sound. This study will examine whether providing a nutritional supplement, phosphatidylcholine, for two months in infancy will result in an increased likelihood of developing more robust sensory gating.

NCT ID: NCT01905332 Withdrawn - Clinical trials for Early Childhood Literacy

Preschool Literacy Screening: Validating a 5 Question Survey Using the GRTR-R and the Efficacy of Literacy-promoting Interventions

Start date: July 2013
Phase: N/A
Study type: Interventional

This study's aim is to validate a parent-completed brief literacy screening tool (Early Literacy Screener) at the 4 year well child check using the Get Ready to Read- Revised screening tool as a gold standard. Four year old children who fall below the cutoff score for the GRTR-R will be randomized to either receive current standard of care (control group) or a referral to receive a 6 month home based literacy promoting program (intervention group). After 6 months, both groups will be retested using the GRTR-R. The hypothesis is that the change in raw scores on the GRTR-R in the intervention group after 6 months will be greater than the change in raw scores in the control group.

NCT ID: NCT01904786 Withdrawn - Clinical trials for Newborn Hypoxic Ischemic Encephalopathy

Melatonin Treatment for Newborn Infants With Moderate to Severe Hypoxic Ischemic Encephalopathy

Start date: April 2014
Phase: Phase 1
Study type: Interventional

During the birth process certain conditions can cause oxygen delivery and/or blood flow to the baby's brain to become interrupted. This can cause permanent brain damage. Brain damage occurs in two phases. The first occurs at the time of injury when brain cells in the affected area 'die'. There is nothing that can be done about this. The second phase of injury occurs over the next few days. This second phase is caused by inflammation and release of toxic chemicals from the injured site. Cooling the baby to a temperature of 92.5° F, for 3 days has been shown to reduce the second phase of injury and bran death. All babies will receive the benefit of cooling. Although cooling helps it does not completely stop the second phase of injury. Melatonin is a naturally occurring hormone that is produced by the brain, and helps regulate the sleep-wake cycle. It has the potential to stop the second phase of brain injury by inhibiting inflammation and release of toxic chemicals. The reason for this research is to find out if melatonin can or cannot improve the outcome of babies with this kind of brain damage. Every baby enrolled in the study has a 50:50 chance of getting melatonin. A total of six doses of medicine will be given. The baby's brain function will be assessed by an EEG, brain oxygen monitoring, and a neurologic examination at 18 months of life. All of these are routinely used as part of standard care for patients with this kind of problem. The only difference is that half the babies enrolled in the study will get the drug called melatonin and the other half will receive placebo. The dose of melatonin being used in the study is higher than the amount normally produced by the body. No side-effects of this dose have been reported in other research studies using melatonin in newborn and premature babies.

NCT ID: NCT01903317 Withdrawn - Psoriasis Clinical Trials

Evaluation of Vitamin D Levels in Psoriasis Patients

Start date: June 2013
Phase:
Study type: Observational

The purpose of this research study is to find out more about the relationship between vitamin D and psoriasis.

NCT ID: NCT01902550 Withdrawn - Healthy Clinical Trials

A Crossover Study to Evaluate the Effect of JNJ-54452840 on Pharmacodynamics of Metoprolol Tartrate Immediate-Release in Healthy Participants

Start date: July 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate effect of co-administration of JNJ-54452840 and metoprolol tartrate immediate-release (metoprolol IR) compared to metoprolol IR alone on the exercise heart rate and blood pressure measured at the end of each 3-minute exercise test in healthy participants.

NCT ID: NCT01901939 Withdrawn - Aging Clinical Trials

Role of Exercise in Reversal of Hospitalization-associated Disability in Elderly

Start date: February 2014
Phase: N/A
Study type: Interventional

The proposed preliminary study from this interdisciplinary team will provide important information about the feasibility and safety of bedside low intensity pedaling exercise during hospitalization. The findings from this study are essential to develop high-value, effective treatments that can be used by any hospital setting throughout the country. The program that investigators are proposing may provide important changes in how disability can be prevented in elderly patients who are hospitalized because of an acute illness.

NCT ID: NCT01897090 Withdrawn - Crohn's Disease Clinical Trials

A Crohn's Disease Diet to Reduce Symptoms of Crohn's Disease

Start date: January 2013
Phase: N/A
Study type: Interventional

A 16-week randomized, pilot study to determine if an elimination diet reduces symptoms of Crohn's disease. Sixty (60) adult patients (18-75 yrs) with a mild or moderate Crohn's Disease Activity Index (CDAI) of 150-450, will be recruited through the GI practices at Johns Hopkins University. Patients agree not to be on any other major treatments, with the exception of consistent/stable doses of 5-aminosalicylate (ASA) drugs/other medications during the course of the study and will obtain their physician's permission.They will be divided into a treatment and standard diet group: thirty (30) patients will be on the "Crohn's Disease Diet" (primarily an "anti-inflammatory diet that is an elimination diet - gluten-free, casein-free based with limited carbohydrate) and thirty (30) patients will be given the Dietary Guideline recommendations and similar dietary counseling attention. To assess the clinical efficacy and tolerance of the trial population, patients will be monitored by two office visits (at 0 and 12 weeks) by visits with the Clinical Research Unit (CRU) registered dietitians (RDs) at 0, 6, 12, and 16 weeks (4 weeks after the end of the study) for blood and dietary data collection. Clinical endpoints will be Crohn's disease Activity Index (CDAI) scores (remission < 150; mild = 150-220; moderate = 220-450; severe = 450+), C-Reactive Protein (CRP) values (0-0.8 mg/L), sedimentation rate /(male: 15-20 mm/hr, female: 20-30 mm/hr)/, possibly interleukin-6(/normal value: <10pg/ml)/, Overall Quality of Life (QOL) through the Inflammatory Bowel Disease Questionnaire (IBDQ), Dudley IBD Symptom Questionnaire (DISQ) surveys, and Brown's Gastrointestinal Quality of Life (QOL) Questionnaire, and health care costs measured by a health care cost questionnaire.

NCT ID: NCT01896947 Withdrawn - Clinical trials for Superior Labrum Anterior Posterior Lesion

3T MRI Versus MR Arthrogram in SLAP Lesions

Start date: September 2013
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the diagnostic performance of three Tesla magnetic resonance imaging (3T MRI) compared to magnetic resonance arthrogram (MR arthrogram) in diagnosing superior labrum anterior posterior (SLAP) lesions. We hypothesize that 3T MRI will have non-inferior sensitivity compared to MR arthrogram in diagnosing SLAP lesions utilizing arthroscopy as our gold standard test. To evaluate our hypothesis, the investigators will include patients suspected to have a SLAP lesion on history and physical examination by a fellowship trained orthopaedic surgery. Patients will be offered advanced imaging (both 3T MRI and MR arthrogram) as well as arthroscopy for definitive diagnosis and treatment after consent is obtained. A fellowship trained musculoskeletal radiologist will perform and interpret the magnetic resonance tests while the arthroscopy will be performed by orthopaedic surgeons. The diagnostic characteristics of each imaging modality, including sensitivity, specificity, negative predictive value, and positive predictive value, will be compared to each other.

NCT ID: NCT01896440 Withdrawn - Clinical trials for Malignant Childhood Neoplasm

Heart Safety Study of Ondansetron in Children Receiving Chemotherapy

Start date: October 2013
Phase: Phase 4
Study type: Interventional

We will study the effects of ondansetron on measurements of electrical activity in the heart to make sure doses we are using to prevent nausea and vomiting in children receiving chemotherapy are safe.

NCT ID: NCT01895881 Withdrawn - Menopause Clinical Trials

Estrogen Therapy as Prevention in the Progression of Aneurysm (EPPA) Trial

EPPA
Start date: April 2013
Phase: Phase 2
Study type: Interventional

This study aims to determine if hormone replacement therapy, given during perimenopause may prevent the progression of saccular cerebral aneurysms.