This qualitative and feasibility study will involve the development, distribution, and evaluation of “period kits” for 15-25 pre-menarchal adolescents with intellectual and developmental disabilities (IDD) (e.g., autism, Asperger’s syndrome, and Down syndrome) in relieving stress and augmenting preparedness concerning menstruation and other imminent pubertal changes.
This clinical investigation is intended to evaluate the safety and effectiveness of Abbott’s AmplatzerTM AmuletTM Left Atrial Appendage (LAA) occluder device (“Amulet device”) compared to commercially available non-vitamin K antagonist oral anticoagulant (NOAC) drugs in patients with non-valvular atrial fibrillation (AF) who are at increased risk for ischemic stroke and who are tolerant of long-term NOAC therapy.
This research is to determine the performance characteristics of a urine-based test for the detection of recurrent bladder cancer in low-grade patients who have been treated according to standard practice and are undergoing routine surveillance cystoscopy. The cystoscopy is regarded as the gold standard for determining recurrence of cancer. The Co-Principal Investigator at Tufts University has developed a urine-based monitoring test of bladder cancer, using imaging of the surface of cells extracted from the patients’ urine.
Approximately 230,000 women are diagnosed with invasive breast cancer and 60,000 women are diagnosed with ductal carcinoma in situ (DCIS) (breast cancer in the breast milk ducts) annually in the US. Most women choose to be treated with breast conserving surgery (BCS). The goal of BCS is to resect the tumor with a surrounding margin of tissue free of cancer, and to minimize the volume of tissue removed, thereby preserving the overall shape and appearance of the breast.
This phase III trial compares the effects of olanzapine versus megestrol acetate in treating loss of appetite in patients with cancer that has spread to other places in the body (advanced). Olanzapine may stimulate and increase appetite. This study aims to find out if olanzapine is better than the usual approach (megestrol acetate) for stimulating appetite and preventing weight loss.
This study explores changes in heart function before and after activation of Impella or ECMO devices used to support subjects in cardiogenic shock.
This is a pilot/feasibility study on the accuracy of HRV measured by the Apple Watch on the clinical status of patients admitted for acute heart failure decompnsation. We hypothesize that there will be a statistically significant improvement in the HRV that correlates clinically over the course of hospitalization. Meaningful findings from this study will strengthen the potential for a telemonitoring system where HRV measured remotely from home using wearable devices like Apple Watch can help physicians monitoring their health and intervene accordingly.
This is a study of the prevalence of APOL1 alleles in adults who are of recent African ancestry or geographic origin. The study will enroll up to a total of approximately 2500 subjects into 2 groups. Group 1 includes subjects with FSGS, and Group 2 includes subjects with other forms of proteinuric nondiabetic CKD. No study drug will be administered.
A Phase 2/3 Adaptive, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Subjects Aged 18 Years and Older With APOL1-mediated Proteinuric Kidney Disease
GO MOMS is a study that tracks maternal blood sugar levels in pregnancy and how the levels may predict the development of gestational diabetes (pregnancy-related high blood sugar) or relate to the size of a baby at birth. As not enough is known about who will get gestational diabetes and because treatment of gestational diabetes in later pregnancy does not make all of the complications go away, learning about the early pregnancy blood sugars may help us learn how to improve prenatal care in the future for healthier families.
The purpose of this study is to measure the effect of maternal diet and metabolism (how your body uses food for energy) on the growth of the baby, and how the placenta uses lipids.
This study will determine how the placenta is affected by glucose in early pregnancy.
The TRIOMPHE study is designed to further evaluate the safety and efficacy of the NEXUS™ Aortic Arch Stent Graft System for the endovascular treatment of thoracic aortic lesions involving the aortic arch including chronic dissections, aneurysms, penetrating aortic ulcers and intramural hematoma.
Premature infants can get a serious inflammatory condition, called necrotizing enterocolitis (NEC), that damages parts of the intestines. It is the most common cause of illness of the intestinal tract in premature infants in the first few weeks of life. It is a very serious condition that can lead to death in up to half of affected infants. There is no way to predict whether an infant will get NEC, and there are no reliable early warning signals. There is no established preventive treatment for NEC.
The purpose of this study is to study environmental risk factors and epigenetic processes as potential contributors to neurodevelopmental impairments in a group of individuals at very high risk by focusing on the relationship of prenatal exposure to placental inflammation markers and neonatal inflammation markers, the relationship of these inflammation markers to functional neuodevelopmental disorders and on the relationship of these markers to brain structural abnormalities.
The primary objective of the study is to evaluate the safety and efficacy of inhaled treprostinil in subjects with IPF. This study hypothesizes that inhaled treprostinil will have a positive effect on absolute FVC after 52 weeks of therapy as compared with placebo when administered to subjects with IPF.
To evaluate the systemic exposure of treprostinil after inhaled administration in subjects with idiopathic pulmonary fibrosis (IPF)
This is a Phase 3, randomized, double-blinded, placebo-controlled study to compare the efficacy and safety of sotatercept versus placebo when added to background pulmonary arterial hypertension (PAH) therapy for the treatment of PAH. The objective of this study is to evaluate the efficacy and safety of sotatercept treatment (plus background PAH therapy) versus placebo (plus background PAH therapy) at 24 weeks in adults with PAH.
This is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate sotatercept when added to background PAH therapy in newly diagnosed intermediate- and high-risk PAH patients.
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, parallel-group study. The objective of this study is to evaluate the effects of sotatercept treatment (plus maximum tolerated background PAH therapy) versus placebo (plus maximum tolerated background PAH therapy) on time to first event of all-cause death, lung transplantation, or PAH worsening related hospitalization of ≥ 24 hours, in participants with WHO FC III or FC IV PAH at high risk of mortality.
