16 Clinical Trials for Various Conditions
The purpose of the study is to investigate in healthy human subjects how much desmetramadol (Omnitram) gets in the blood after different oral doses are taken with or without food.
This study will evaluate the feasibility of using a sub-therapeutic dose of a fluorine-18 analogue of NP-59 (\[18F\]FNP-59) to image the adrenal gland. Some participants are healthy normal subjects but have undergone interventions to manipulate hormones while other participants have known adrenal pathology.
This exploratory, first-in-man, phase 0 study will evaluate the feasibility of using a sub-therapeutic dose of a fluorine-18 analogue of NP-59 (\[18F\]FNP-59) to image the adrenal gland in healthy normal subjects. The researchers believe that \[18F\]FNP-59 would greatly improve the imaging characteristics, by providing a PET imaging cholesterol analogue with significantly improved radiation dosimetry.
Despite some controversial results, many patients and animal studies have suggested significant benefit of using hypothermia treatment in stroke patient population. However, certain questions for how to applying this therapy properly such as when to start, what is the optimal temperature, how long is the duration, and what is the best hypothermia technology that may avoid the complications including focal soft tissue injuries are still remain questioned. In this study, we will utilize the linear relationship of temperature vs. chemical shift in MR Spectroscopy to measure the brain temperatures in normal men.
The objective of the study is to acquire a database of Single Photon Emission Computed Tomographic (SPECT) studies of the brains of normal human subjects in resting and concentrating states. The database will provide a basis for subsequent investigation of meaningful brain differences between clinical and normal subject groups
This is a pilot study. The purpose of the study is to facilitate the development of a new biomarker of cystic fibrosis transmembrane conductance regulator (CFTR) function using rectal tissue.
Background: Magnetic resonance imaging (MRI), which uses strong magnets to get images of structures inside the body, is a valuable tool in modern medicine. But researchers are always looking for ways to improve this technology. To better understand how to use MRI to diagnose problems, researchers need to collect more data from scans of healthy people. Objective: To get MRI scans of healthy people to improve the measurements doctors can make from the images. Eligibility: People aged 18 years or older in good general health. Design: Participants will be screened. They will have a physical exam focused on their nervous system. They will complete questionnaires. Participants will have at least 1 MRI scan. The target of the scan may be the brain, liver, prostate, breast, or other body part. Before the scan, participants will remove any metallic objects. They will lie on a narrow table that moves into a long, narrow tube. They may have special pads placed around them to help them remain still. Participants will hear loud noises during the scan. They will get earplugs or earmuffs to wear to muffle the sound. They can communicate with the MRI technician and will have an emergency button to squeeze at any time if they want the scan to stop. The scan will take up to 2 hours. Some participants may be asked to perform tasks on a computer screen during the scan. Participants may return for up to 5 scans in 3 months. Some may have as many as 30 MRI visits per year. They may remain in the study for up to 2 years....
Prostate cancer represents a significant health problem in the United States. This year 179,000 men in the United States will be diagnosed with prostate carcinoma and approximately 25% of them will die of the disease. In addition, the incidence and mortality of prostate carcinoma has been increasing steadily in the United States. Prostate-specific antigen (PSA) levels are commonly used as a biomarker for the detection of prostate cancer. Nonetheless, there is a significant false negative and false positive diagnosis since PSA levels elevate in benign prostatic hyperplasia and prostatitis and decrease in patients taking medications and herbal remedies. Twenty percent of biopsy-proven prostate carcinoma have PSA levels within the normal range, thus confounding the diagnosis based on the PSA screening test. Current diagnostic methods that include transrectal ultrasound (TRUS) and TRUS guided prostate biopsy are logistically difficult and insensitive. These are further complicated by equivocal prostatic biopsy findings such as prostatic intraepithelial neoplasia (PIN) or normal PSA with high clinical suspicion. A tracer with high specificity to prostate cancer related structures at a cellular level would enhance our understanding of the pathophysiology of prostate cancer and would contribute to the detection, localization and quantification of the disease and its metastases. This information will be invaluable in selecting the appropriate treatment regimen. This study will test the utility of \[F-18\]FMDHT to image prostate cancer and will evaluate if this radiotracer can differentiate primary prostate cancer in the prostate gland from normal prostate gland itself. More specifically, we will study the distribution kinetics of \[F-18\]FMDHT in normal healthy humans and in patients with prostate cancer. As per exploratory IND requirements, we performed toxicity assessment of FMDHT through an outside laboratory (ILS, Inc.) and the results of that study are attached as Appendix A. Based on our and others data, we hypothesize that: 1. \[F-18\]FMDHT PET/CT will distribute initially in various normal tissues following blood flow pattern and will clear rapidly from tissues with no AR. 2. \[F-18\]FMDHT PET/CT will detect metastatic disease that expresses AR. 3. \[F-18\]FMDHT PET/CT uptake will be elevated in AR-expressing prostate cancer lesions compared to surrounding normal prostate. In order to progress \[F-18\]FMDHT into clinic, we are performing a pilot 'first-in-human' biodistribution study in subjects with and without prostate cancer.
Levels of tocotrienol in human tissues following supplementation is not currently known. The objective of this present study is to determine the levels of this form of vitamin E in the human tissues such as skin, heart, lung, liver, adipose tissue, Brain and cerebrospinal fluid (CSF) following oral supplementation
This protocol is being submitted to consolidate, update, and expand two previously approved protocols (77-C-0066 and 82-C-0044) into a single protocol. The purpose of this study is to examine the factors involved in the regulation of the immune system of healthy individuals and to define the abnormalities in this regulation that underlies the immunological disorders of patients with a variety of immunodeficiency and malignant disorders. The studies will include the ex vivo phenotypic and functional analysis of the network of cells involved in humoral and cellular immune responses, and in vivo testing for the capacity to make delayed-type hypersensitivity and humoral responses following immunization with a variety of antigens. Individuals to be studied will include patients with a variety of malignancies and patients with primary and secondary immunodeficiency disorders. Selected family members or family members known to be genetic carriers of certain immunodeficiency diseases as well as normal, unrelated individuals will also be studied. A small number of procedures will be used including analysis of blood obtained by phlebotomy, apheresis, skin testing and recall antigens and immunization to assess humoral immunity....
Background: * For every CHI research study, patients must fulfill a list of criteria, based primarily on their medical condition. To determine whether a patient meets these eligibility criteria to participate in a research protocol, researchers must perform a series of diagnostic tests and procedures. * These evaluations are designed to evaluate a participant s general medical condition (i.e., blood tests, function of certain organs such as the lungs, heart, liver, or kidneys), and to confirm a diagnosis or ensure that a healthy volunteer is in good condition. They maximize the safety for the patients and healthy volunteers at CHI. Objective: - To determine the eligibility of patients and healthy volunteers for active CHI research protocols. Eligibility: * The procedures included in this protocol will determine eligibility for active CHI research protocols. * Both healthy volunteers and patients will be evaluated. Design: * Required tests and procedures for various research studies may include the following: history and physical examination, blood and urine tests, lung and heart function tests (echocardiogram, electrocardiogram, stress test), imaging studies (X-rays, magnetic resonance imaging (MRI), computerized tomography (CT), and tissue collection. * Participants will be asked to undergo tests only for the study or studies for which they are being considered. The research team will provide further information on any additional tests that may be required. * After all eligibility assessments are complete, participants may be offered participation in one or more CHI research protocols or referred back to a home physician.
To find a recommended dose of attIL2-T cell therapy that can be given to patients with soft tissue or bone sarcomas and to see if it can help to control the disease.
The purpose of this study is therefore to evaluate the effect of concomitant drugs through an increase of intra-gastric pH levels on the bioavailability of entinostat. The primary objectives of this study are to evaluate the effect of multiple doses of omeprazole, famotidine, and the effect of an acidic beverage in combination with omeprazole on the single-dose PK profile of entinostat. The secondary objectives are to evaluate the safety and tolerability of a single dose of entinostat when administered with multiple doses of omeprazole, famotidine, and when administered with an acidic beverage in combination with omeprazole.
This is a multicenter, open-label, phase 1 study conducted to test intratumoral injections of TTI-621 in subjects that have relapsed and refractory percutaneously accessible solid tumors or mycosis fungoides. The study will be performed in two different parts. Part 1 is the Dose Escalation phase and Part 2 is the Dose Expansion phase. The purpose of this study is to characterize the safety profile of TTI-621 and to determine the optimal dose and delivery schedule of TTI-621. In addition, the safety and antitumor activity of TTI-621 will be evaluated in combination with other anti-cancer agents or radiation.
Human induced pluripotent stem cells (hiPSCs) have driven a paradigm shift in the modeling of human disease; the ability to reprogram patient-specific cells holds the promise of an enhanced understanding of disease mechanisms and phenotypic variability, with applications in personalized predictive pharmacology/toxicology, cell therapy and regenerative medicine. This research will collect blood or skin biopsies from patients and healthy controls for the purpose of generating cell and tissue models of Mendelian heritable forms of heart disease focusing on cardiomyopathies, channelopathies and neuromuscular diseases. Cardiomyocytes derived from hiPSCs will provide a ready source of disease specific cells to study pathogenesis and therapeutics.
The primary purpose of this study is to measure and compare the amount of study drug in your blood after a single dose of two formulations of study drug.