Treatment Trials

17 Clinical Trials for Various Conditions

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RECRUITING
Health Effects of Repeated Exposure to Low Levels of Concentrated Ambient Particles in Healthy Young Volunteers
Description

Purpose: To determine whether 3-day consecutive exposures to levels of fine particulate matter (PM2.5) that are close to the current 24-hr national standard will cause changes in inflammatory and cardiopulmonary endpoints in healthy young individuals. Participants: 20 healthy males and females aged 18-35 years. Procedures (methods): Subjects will be randomly exposed to three consecutive days of filtered air (4 hr/day) and three consecutive days of PM2.5 (approximately 35 µg/m3; 4 hr/day) in an exposure chamber. Blood collection for inflammatory factors such as C-reactive protein (CRP), clotting factors; heart rate variability (HRV); spirometry; and a symptom questionnaire will be conducted before and after each exposure.

Conditions
COMPLETED
Neurogenetic Pharmaceuticals (NGP) 555 in Healthy Young Volunteers (Single-ascending Dose)
Description

NGP 555 is a small molecule preventative therapy aimed at reducing Alzheimer's disease amyloid buildup by targeting Abeta 42 production.

COMPLETED
A Single Dose Study to Assess the Safety, Effects, and Blood and Urine Drug Levels of AZD3293 in Healthy Subjects
Description

This is a single dose study in healthy male and female (of non-child bearing potential) volunteers, to assess the safety, effects on the body, and blood and urine drug levels of AZD3293. AZD3293 is being developed for the treatment of Alzheimer's Disease

WITHDRAWN
Synthetic and Natural Caffeine on Hemodynamic Parameters in Young, Healthy Volunteers
Description

The purpose of this study determine the difference in hemodynamic effects of synthetic and natural caffeine consumption in healthy individuals through blood pressure (central and peripheral) assessment. Participants will randomly be assigned to consume either one 8oz cup of coffee containing 400mg of caffeine (increased caffeine using concentrated coffee) or one 8oz cup of coffee-flavored drink with approximately 400mg synthetic caffeine from capsules dissolved in it.

COMPLETED
Evaluation of Energy Drink Consumption on ECG and Hemodynamic Parameters in Young Healthy Volunteers
Description

This study is designed as a safety assessment to determine the cardiac and hemodynamic effects of overuse of energy drinks in healthy individuals through ECG, heart rate (HR) and blood pressure measurements. It will evaluate the use of a consumer available product that is classified as a dietary supplement by the FDA.

COMPLETED
Usability, Acceptability, and Safety of Virtual Reality-based Cognitive Intervention
Description

This study aims to determine feasibility, acceptability, and usability, and to assess the safety of using a virtual reality-based software called ''ReCognitionVR'' in healthy volunteers.

Conditions
COMPLETED
Genetic Mutations and Environmental Exposure in Young Patients With Retinoblastoma and in Their Parents and Young Healthy Unrelated Volunteers
Description

This laboratory study is looking at genetic mutations and environmental exposure in young patients with retinoblastoma and in their parents and young healthy unrelated volunteers. Gathering information about gene mutations and environmental exposure may help doctors learn more about the causes of retinoblastoma in young patients.

COMPLETED
Study of the Pharmacokinetics of ASP1941 and the Effect on Glucose Concentrations in Male and Female Young and Elderly Healthy Adults
Description

This is a study of the pharmacokinetic profile and safety and tolerability of ASP1941after repeat dosing and the effect of ASP1941 on glucose levels in non elderly and elderly healthy adult male and female subjects.

COMPLETED
Evaluation of Salt Sensitivity in Young Adults
Description

The current prospective cross-sectional pilot study is proposed to determine a set of characteristic factors associated with salt sensitivity in young adults by measuring blood pressure, serum aldosterone levels, urine analysis, arterial pulse wave velocity and central arterial pressure in response to short term increases in salt intake.

COMPLETED
Adrenal Hyperplasia Among Young People With PCOS
Description

Background: - Polycystic ovarian syndrome (PCOS) is a group of disorders related to problems with the secretion of certain hormones, which can lead to reproductive and other issues in women. Frequent complications of PCOS include irregular menstruation, development of ovarian cysts, and insulin resistance. The adrenal glands, which sit on top of the kidney, are involved in the production of certain hormones and the regulation of steroid levels in the blood, and may be affected in women with PCOS. Researchers are interested in studying possible connections between the adrenal glands and PCOS in young women who have been diagnosed with PCOS and healthy volunteers with normal menstrual function. Objectives: - To investigate possible connections between adrenal gland steroid hormone secretion and polycystic ovarian syndrome. Eligibility: * Women between 16 and 29 years of age who have been diagnosed with PCOS, or who are healthy volunteers with normal menstrual function. * Participants must be willing to discontinue the use of oral contraceptives or any other medications that alter steroid hormone production for at least 1 month before the start of the study. Design: * Participants will be screened with a physical examination, medical history, and blood and urine tests. All participants will also have a pelvic (ovarian) ultrasound. * All participants will be admitted to the hospital for a 1-week testing period, which will involve the following tests: * Regular blood draws for two 2-hour periods (late evening and early morning) to measure hormone levels * Fasting blood draws with a dose of corticotropin to test the body's adrenal function * Hormone level measurement following regular doses of dexamethasone (a drug that controls the function of the adrenal gland) * Daily urine collection for 6 days. * Other studies, such as imaging studies of the adrenal glands, may be conducted as required by the study researchers.

COMPLETED
Evaluation of Cortisol Resistance in Young Sedentary and Endurance-Trained Men
Description

This study proposes to examine multiple aspects of the hypothalamic-pituitary-adrenal axis in younger endurance trained and sedentary men, and in older sedentary men.

TERMINATED
A Phase I Study of Quadrivalent Human Papilloma Virus (HPV) (Types 6, 11, 16, 18) Recombinant Vaccine in HIV-Infected and HIV-Negative Pre-Adolescents, Adolescents, and Young Adults
Description

Background: * Human papilloma virus (HPV) is a common sexually transmitted disease. There are more than 100 different HPV types, and both males and females can get HPV infection. Most people do not have any symptoms when they become infected and are able to get rid of the infection on their own. However, they can still become re-infected with the same or a different HPV type, and in some people HPV infection persists. * Persistent HPV infection is associated with the development of precancerous lesions and cancer. HPV types are classified as either high risk or low risk based on whether their persistence will lead to cancer. * Patients who have suppressed immune systems are at a higher risk for HPV-related complications. They are more likely to contract multiple HPV types and have more persistent infection that can lead to precancerous lesions or cancer, which are then difficult to treat and often recur. * A recently approved vaccine for HPV induces immunity to HPV 6, 11, 16, and 18. It was shown to be highly effective in preventing infection with these HPV types, and is approved for use in females 9 to 26 years of age. However, much less is known about the vaccines ability to induce immunity in males or individuals with suppressed immune systems. Objectives: - To investigate whether the HPV vaccine is safe to give and able to induce immunity in both female and male adolescents and young adults with HIV infection compared to healthy, human immunodeficiency virus (HIV)-negative persons of the same age. Eligibility: - Males and females, 12 to 26 years of age, divided into three groups: (1) Healthy and HIV-negative, (2) HIV-positive and on antiretroviral therapy, and (3) HIV-positive and not on antiretroviral therapy. Design: * Before beginning vaccination, participants will have a complete physical examination and blood drawn for routine blood tests, special tests of the immune system, antibody tests, and an HIV test. * HPV vaccine will be given by injection into the muscle at 0, 2, and 6 months, according to the standard vaccination schedule. * Patients with HIV infection will be monitored for a week following the first injection to test the level of HIV in the blood 3 days and 5 days after the first injection. * Participants will also be asked to fill out a 10- to 15-minute Web-based survey about awareness, health behaviors, and personal choices related to risk factors for HIV, HPV, and other sexually transmitted diseases. Participants are not required to fill out the survey to receive the vaccine. * The total duration of the study is 4 years. During the first year of the study, participants will return for six additional 1-day visits at months 1, 2, 3, 6, 7, and 12. Participants will return for 1-day visits every 6 months for the remaining 3 years.

COMPLETED
Dynamic Light Scattering to Study Crystalline Proteins in Young Normal Lenses
Description

This study will use a method called dynamic light scattering (DLS) to study the lens of the eye in young normal subjects. The DLS device uses a very dim laser light to study the lens of the eye. It detects proteins in the lens, identifying early changes that may make the device useful in future cataract studies. This study will use DLS to examine the characteristics of proteins in healthy young lenses that can be used for comparison with lenses in older people and people with cataracts. Normal volunteers aged 5 to 21 years may be eligible for this study. Participants undergo the following procedures: Medical history Eye examination with dilation to include: * Measurement of visual acuity * Examination of pupils and eye movements * Examination of the front of the eye (cornea, lens) with a slit lamp bio-microscope * Examination of retina with an ophthalmoscope (instrument with a strong light and magnifying lens) * Dynamic light scattering

Conditions
COMPLETED
MRI Language Studies in Young Children
Description

This study will use magnetic resonance imaging (MRI) to investigate language function in children-that is, how language skills such as naming objects, understanding spoken language and reading are organized in the brain. The study focuses on children between 4 and 7 years old. Children 8 to 12 years old and adults will be studied before the younger children to test study paradigms appropriate for pre-literate children. The results of this study will help evaluate the usefulness of MRI in identifying language function and location and may improve the treatment of children with seizures. Right-handed, native English-speaking adults and children between 4 and 12 years of age may be eligible for this study. Candidates will be screened with a routine neurological examination. Children will also undergo neuropsychological testing (standard tests of language, memory, perception and attention) either at the screening visit or at a later time. Parents will fill out a form to identify children with attention deficit and hyperactivity disorders. These children will be excluded form the study. All participants will undergo MRI scanning of the brain while performing a task designed to test a language skill, such as identifying a picture or listening to or reading a word. The MRI detects changes in blood properties in the areas of the brain that perform each task. Before the MRI, children will be rehearsed for the tests and will have a session in the scanner to know what to expect and feel more at ease during the actual test. The time in the MRI machine is usually between 15 and 20 minutes, but will be no more than 40 minutes for children 8 to 12 years old, and not more than 20 minutes for younger children. Children may be requested to have up to five MRI sessions to test different brain functions or confirm findings. ...

Conditions
COMPLETED
Effect of Stimulus Rate on Cognitive and Motor Activity in Young Subjects, Elderly Subjects, and Patients With Parkinson's Disease
Description

The purpose of this study is to investigate how changes in the brain associated with Parkinson's disease influence the control of motor and thinking speed. There is disagreement over whether patients with Parkinson's disease are slow in thinking as well as movement. This study may provide a new framework to explain the relationship between motor and cognitive aspects of human behavior and help to clarify the pathophysiology of Parkinson's disease. There are two parts to the study: behavioral tests and functional magnetic resonance imaging (fMRI). All participants will be asked about their medical history, have a physical examination, and complete a questionnaire. They must not take regular medications, including levodopa and dopamine agonists, for 8 hours prior to the study. The behavioral study involves computer-generated neuropsychological tasks, including hand movements, imagination of movements, and mental calculations. Response will be recorded and evaluated. Electrodes may be placed on the participant's skin to measure surface electromyogram (EMG). The fMRI study involves MRI scanning in which motor and thinking tasks are performed. Electrodes may be placed on the skin to monitor muscle activity. Thirty patients, ages 40 and up, with early-stage Parkinson's disease will be recruited. Sixty normal volunteers ages 21-75 will be included as well for comparison.

COMPLETED
Omega-3 Fatty Acids and Muscle Protein Synthesis
Description

The purpose of this study is to determine whether omega-3 fatty acid supplementation influences muscle protein synthesis rates in young and older adults.

Conditions
RECRUITING
Cardiometabolic Benefit of Reducing Iatrogenic Hyperinsulinemia Using Insulin Adjunctive Therapy in Type 1 Diabetes
Description

This study aims to understand the heart and blood sugar health benefits of using an adjunctive therapy to lower high insulin levels in people with type 1 diabetes. The investigators will also look at people with a specific type of diabetes called Glucokinase-Maturity Onset Diabetes of the Young (GCK-MODY) and those without diabetes to help interpret the results. The investigators will use a medication that helps the body get rid of sugar, called and SGLT2 inhibitor, with the goal to reduce the body's insulin requirements. The investigators believe this could lead to better heart and blood sugar health, including a better response to insulin and more available nitric oxide, a gas that helps blood vessels function well. The investigators will compare heart and blood sugar health risk factors in participants with type 1 diabetes, participants with Glucokinase-Maturity Onset Diabetes of the Young (GCK-MODY), and non-diabetic healthy volunteers under two conditions: high insulin levels typical of type 1 diabetes and normal insulin levels typical of the other two groups.