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To compare the efficacy of a combined contraceptive vaginal ring (NuvaRing) and oral Norethisterone Acetate in treatment of Idiopathic heavy menstrual bleeding during fertile age

Study design: In a randomized parallel controlled study 86 patients will be randomly assigned to either MRA therapy or CPAP therapy. Group A receives MRA. Group B receives CPAP. The total duration of the study is 12 months. Measurements will be done at baseline, after 3, 6 and 12 months. Intervention: Group A will be treated with a bibloc MRA (Somnodent). The mandible will be set at 70% of the patient's maximum advancement and will be adjusted to the convenience of the patient. Titration will be continued until symptoms abate or until further advancement causes discomfort. Group B will be treated with CPAP. Proper CPAP-pressure will be set for each patient separately. Patients are fitted with a comfortable CPAP mask before titration of the CPAP-pressure. For CPAP-titration, patients are instructed to adopt their own typical sleeping habits. The purpose of this study is to compare the cost-effectiveness and effectiveness of mandibular repositioning appliance (MRA) versus Continuous positive airway pressure (CPAP) therapy in patients with moderate Obstructive Sleep Apnea Syndrome (OSAS).

The specific aims for this project are to enroll up to 10,000 subjects who will have their genomes surveyed using the Navigenics™ Health Compass technology. The Navigenics Health Compass helps you understand what your genetic variants have to say about the future of your health, and gives you action steps to take control of your health today. In addition, the investigators will assess how the Navigenics Health Compass, results affect lifestyle decisions. The phenotyping information that can be analyzed with the resulting Navigenics genotype information will assist in identifying genetic variations associated with other traits and diseases. The uses of molecular markers such as cholesterol and glucose levels to assess disease risk are well established in clinical medicine today. Although these tools are useful in screening for subclinical disease, their predictive value is limited. Until recently, these molecular markers were the best risk assessment and screening tools in existence. Since the completion of the Human Genome Project, the era of personalized medicine, which exploits knowledge of the genes an individual carries that may predispose him/her to disease, has come to the forefront of research. The Navigenics Health Compass technology assesses risk for about over 20 common diseases and provides subjects with more accurate assessments of their individual predictive risk for developing these conditions than traditional biomarkers such as cholesterol and glucose levels. This may positively influence changes in lifestyle, as well as decisions to seek further medical evaluation associated with preventive strategies.

The investigators want to prove that people WITHOUT advanced cancer who are taking opioid medications (for problems like back pain) can receive methylnaltrexone (MNTX) safely. Since the FDA has only approved MNTX for advanced cancer patients, the investigators' research is investigating how MNTX can work for NON-cancer patients. This research is being conducted to prove that MNTX can work for non-cancer patients with opioid related constipation.

Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by intra and peri-articular synovial inflammation. Synovitis can damage the articular cartilage, bones, joint capsule, tendons and ligaments leading to the consequential functional joint deterioration. The main goal of RA treatment is to achieve disease remission. The treatment of RA consists of synthetic and biologic disease modifying drugs (DMARDs), being the second ones selected when low disease or remission is not achieved with the first ones. Therapeutic response monitoring in RA should be closely managed. It is classically based on clinical exploration and laboratory tests. During the last decade, the resolution improvement of musculoskeletal ultrasound (MSUS) imaging has led to the gradual incorporation of this technique in the evaluation and monitoring of patients with RA, mainly due to its better capacity to detect synovitis than clinical exploration . Ultrasound imaging is highly available, non-invasive, reproducible, affordable and well accepted by patients. Ultrasound doppler mode detects pathological synovial flow, which reflects synovial inflammation and has a demonstrated sensitivity to change in multiple longitudinal studies. Sonographic evaluation of patients with RA includes the detection of synovitis in B and Doppler mode in the joints accessible by ultrasound. There has been high variability in the literature regarding the number of joints that should be evaluated for an appropriate monitoring of the RA patients. The validity for monitoring the therapeutic response in long standing RA has been demonstrated in three reduced joint counts, including 12, 7 and 6 joints. However, in shorter evolution RA, the sensitivity to change of any of these reduced ultrasound evaluations has never been studied Primary objectives • To evaluate the sensitivity to change of the Doppler Ultrasound evaluation of 12, 7 and 6 joints counts in RA patients with more than 6 months and less than 5 years of evolution, which initiate an effective treatment for the disease according to indication (biologic DMARD in monotherapy or combined with methotrexate).

Coronary Heart Disease (CHD) remains a significant problem in the US, causing about 1 of every 5 deaths in 2005. In 2009, approximately 1.3 million Americans will have a new/recurrent myocardial infarction. Coronary heart disease (CHD) includes myocardial infarction, stable or unstable angina, demonstrated myocardial ischemia detected by noninvasive testing, and a history of coronary artery procedures (such a stent or bypass). Currently, "statins" are recommended by the AHA to manage elevated low-density lipoprotein-cholesterol (LDL-C). Unfortunately, the discontinuation of statins is quite substantial. For example, a large cohort study of older patients found that 2-year statin adherence rates were approximately 40% for acute coronary syndrome patients, 36% for chronic coronary artery disease, and 25% for primary prevention and is associated with increased mortality, hospitalizations, and costs. Recently, the kinesin 6 (KIF6) gene has been associated with a 30-55% increase in cardiovascular events in individuals carrying one or two risk variants (~57% of the white population) in multiple prospective studies. Furthermore, KIF6 carriers receiving a "statin" have a substantial greater cardiovascular risk reduction (-34 to 50%) when using a "statin" compared to those that are non-carriers using a statin (6 to 20%). In this prospective, open label, trial, recruited subjects recently started on statin therapy will be provided information about their KIF6 carrier status and followed for 6 months to determine their "statin" adherence. Additionally, quality of life and factors adherence will be measured at baseline and after 6 months. Finally, pharmacy records will be evaluated for up to 1-year to determine statin discontinuation rates. Many patients prescribed statins to lower their cholesterol stop taking their statin over time. The purpose of this study is to determine whether providing subjects their KIF6 carrier status (associated with increased cardiovascular event risk) will improve adherence to statin medications.

Retinal vasculopathy with cerebral leukodystrophy (RVCL) is a very rare and uniformly fatal genetic condition that affects the microvasculature. Symptoms begin in adulthood (usually in the 40s) and include loss of vision, mini-strokes, and dementia. RVCL includes three conditions which were previously thought to be distinct: hereditary endotheliopathy, retinopathy, nephropathy, and stroke (HERNS); cerebroretinal vasculopathy (CRV); and hereditary vascular retinopathy (HVR). RVCL is inherited in an autosomal dominant manner and is caused by carboxyl (C)-terminal heterozygous frameshift (fs) mutations in TREX1 (Three Prime Repair Exonuclease 1). There is no treatment for RVCL, only symptomatic management. TREX1 is an endoplasmic reticulum (ER)-associated (i.e., intracellular) enzyme that, in addition to its DNA repair activities, may regulate sugar metabolism in the ER. TREX1 mutations have also been associated with several autoimmune and autoinflammatory diseases. In RVCL, fs mutations of TREX1 result in C-terminal truncation and this dysregulates the oligosaccharyltransferase (OST) complex leading to free glycan release from dolichol carriers. In mouse models and in patient-derived cells, inhibiting OST with aclarubicin may correct glycan and immune defects associated with fs mutations of TREX1 (Hasan, M. et al., Immunity 43: 1-12, 2015). Aclarubicin (aka aclacinomycin, aclacinomycin-A) is an anthracycline antibiotic isolated from Streptomyces galilaeus cultures. Aclarubicin has been shown to have a broad spectrum of anti-tumor activity. Aclarubicin was utilized for treatment of various cancers in Phase 1 and 2 studies in the United States of American (USA) in the 1980's and 1990's. While no longer clinically employed in the USA, it is commonly used in China and Japan, often as part of a combination drug therapy program for certain malignancies. Aclarubicin is typically administered over 3-5 consecutive days, however, alternative schedules such as weekly or monthly have been evaluated. In solid tumors, the maximum tolerated dose (MTD) of 4-day dosing was 30 mg/m2/day; marrow suppression was dose limiting, otherwise the regimen was well tolerated. Additionally, a Phase II study in acute myeloblastic leukemia was conducted using 100mg/m2 per day for three days and repeated at days 14-16 if marrow hypoplasia was not produced. Toxic effects of this regimen included severe neutropenia, nasea/vomiting, and diarrhea. No changes were noted in left ventricular ejection fraction or no cardiac symptoms developed. RVCL is caused by fs mutations in the C-terminus of TREX1 resulting in low-grade free glycan release, immune activation, and possibly autoantibody production due in part to dysregulation of the OST complex. Inhibiting OST with aclarubicin corrects these glycan and immune defects in mouse models and in patient-derived cells. Thus, inhibiting OST with aclarubicin might be a therapeutic option for patients with RVCL. Given the poor prognosis of RVCL, the lack of treatment options, and the pre-clinical data on OST inhibition by aclarubicin in mice, there is strong rationale for conducting a clinical trial of aclarubicin in patients with RVCL. In this pilot study, aclarubicin will be administered initially at <10% of the single-agent maximum tolerated dose (MTD) in oncology studies. Assessments will be made every six months as to objectives of the study. Patients that do not have clear objective response may be dose escalated by 1 dose level with permission of the principal investigator permitting the patient has not previously experienced any toxicities requiring dose modifications. A patient who has clear objective progression at any time may also have their dose escalated as long as they have completed 1 full cycle at their current dose level. Maximum dose level will be 24 mg/m2/day. The aim of aclarubicin administration in RVCL is not to induce apoptosis, as in oncology studies, but rather to modulate intracellular functions and, thus, a reduced dose will be utilized. The goal of the investigator is to utilize Aclarubicin to treat patients with Retinal Vasculopathy with Cerebral Leukodystrophy (RVCL), a rare and devastating genetic disease with no available specific treatment. RVCL results from a mutation in the tail end of the TREX1 (Three Prime Repair Exonuclease 1) gene, a major deoxyribonucleic acid (DNA) repair enzyme. The RVCL-specific mutations cause expression of a truncated and mislocalized protein. RVCL is an inherited disorder whose symptoms begin at middle age and initially predominantly affects the eye and brain. Because it is an 'autosomal dominant' disease, it strikes both males and females equally. A person with RVCL has a 50-50 chance of transmitting the gene to each child. The investigator's published studies demonstrated in a mouse model for RVCL and in vitro studies with patients' cells that defects were corrected by use of Aclarubicin, an anthracycline antibiotic often used to treat cancer. Thus, there is a strong rationale for conducting a clinical trial of aclarubicin in patients with RVCL. The dosage to be initially administered to RVCL patients initially will be < 10% of that typically used in cancer therapeutics and will be given monthly on four consecutive days for six months. Patients will undergo assessments every six months to determine disease response. Patients that do not have clear objective response may be dose escalated by 1 dose level with permission of the principal investigator permitting the patient has not previously experienced any toxicities requiring dose modifications. We will evaluate the safety and clinical efficacy of Aclarubicin for the treatment of RVCL and evaluate its effects on cellular function. This work will generate the first clinical research data on the investigational product's utility in treating RVCL.

This is an open-labeled dose escalating trial in which a total of 32 subjects (minimum of 24 allowable) will receive one of four intranasal Invaplex 50 vaccine doses according to the following chart: Test articles/dose Group / N* / Invaplex 50 A / 8 / 10 micrograms B / 8 / 50 micrograms C / 8 / 240 micrograms D / 8 / 480 micrograms *minimum of 6 volunteers/group An interval no less than 7 days following the third (and final) dose (total of 35 days between initial dose at the lower dose level and the next initial dose at the next higher dose level) will separate volunteer groups receiving different doses. All volunteers will receive three immunizations. The first dosing time point is Day 0, the second is Day 14 (+- one day), and the third is Day 28 (+- 2 days). Blood and stool specimens will be collected at intervals to examine systemic and mucosal vaccine antigen-specific immune responses. Vaccine safety will be actively monitored during vaccination and for 28 days following the third vaccination dose. The vaccine is given as a nose spray. Volunteers will receive a 3-dose vaccination with doses spaced two weeks apart. Volunteers will be assigned to a vaccination group based on their order of enrollment with consideration of their availability to complete the necessary vaccinations and follow-up visits.

The purpose of this study is to compare the HeRO Vascular Access Device to a conventional ePTFE graft. It is hypothesized that HeRO patency will be comparable to the conventional ePTFE graft control. Compare the HeRO Vascular Access Device to a conventional ePTFE graft.

This study is comparing a drug called Sutent with standard of care treatment for people with advanced thyroid cancer. Because advanced thyroid cancer is becoming increasingly common and effective treatment options are limited, new therapies are desperately needed. This study is designed to see if Sutent following therapy with radioactive iodine will target cancer cells and delay disease progression better than standard therapy alone. Newly diagnosed patients, who are scheduled to receive radioactive iodine as part of their standard care are possible candidates. By entering into this study, participants agree to take oral Sutent for approximately one year after completing standard therapy. During this time, study participants will be followed closely by their doctor. This is a two-stage, phase II with historical controls, single center, targeted therapy trial enrolling patients with stage 2 (for patients younger than 45 years of age), 3 or 4 differentiated thyroid cancer. The primary objective is to assess progression free survival in this population in comparison to historical controls. Sutent will be given orally at 37.5mg daily for two (2) year, or 26 cycles. Each treatment cycle will consist of 28 days. Upon treatment discontinuation, patients will be followed for survival. The frequency and type of survival follow-up assessments performed will be at the discretion of the treating physician.