There are about 173942 clinical studies being (or have been) conducted in United States. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The purpose of this registry is to prospectively assess outcomes of device-treated ventricular tachyarrhythmias and all-cause mortality in non-ischemic cardiomyopathy patients indicated for ICD or CRT-D implantation for the primary prevention of sudden cardiac death. Differences in outcomes will be evaluated by sex and by device type.
The purpose of this study is to compare the efficacy of pembrolizumab + lenvatinib to chemotherapy in female participants with Stage III, IV, or recurrent endometrial carcinoma. It is hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR). It is also hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for overall survival (OS). As of Amendment 7 eligible participants on study completion will be able to transition to an extension study, if available, in which they can continue to receive pembrolizumab monotherapy, lenvatinib monotherapy, or a combination of both pembrolizumab and lenvatinib as received in the parent study.
This is a non-randomized open-label Phase 1 study to evaluate the safety and toxicity of gene therapy using a recombinant adeno-associated virus serotype 9 (AAV9) containing the human lysosome-associated membrane protein 2 isoform B (LAMP2B) transgene (investigational product (IP), RP-A501) in male patients with Danon Disease (DD).
This study is a multi-center, randomized, double-blind, placebo-controlled study in participants 1 to less than 56 years of age who are allergic to peanut and at least two other foods (including milk, egg, wheat, cashew, hazelnut, or walnut). While each participant may be allergic to more than two other foods, the primary endpoint/outcome in this study will only be assessed in peanut and two other foods for each participant. The primary objective of the study is to compare the ability to consume foods without dose-limiting symptoms during a double-blind placebo-controlled food challenge (DBPCFC), after treatment with either omalizumab or placebo for omalizumab.
Currently almost 5 million Americans suffer from the distressing symptoms related to dementia and this number that will triple by 2050. The overall goals of the proposed project are to evaluate, in community dwelling Alzheimer's Disease Research Center participants the benefits of a 12-month nurse-led early palliative intervention on symptoms, quality of life, health care resource use. The relevance of this research to public health is that there is an urgent need to improve the palliative care of persons with dementia living in the community. This study will contribute substantially to that effort.
This is a 12 month, pragmatic trial designed to assess the differences in a digital medicine system (DMS)- ABILIFY MYCITE (Aripiprazole tablets with sensor)- measuring adherence versus treatment as usual (TAU) for adult patients with schizophrenia, bipolar I disorder, and major depression. Outcomes of interest will be adherence as measured by refill rates and all-cause and psychiatric health care use. Each patient will be in the study for a duration of 12 months. All treatment medication decisions will be made by the healthcare professionals (HCPs) and not by protocol. Psychiatrist(s), nurse(s) and/or team manager(s) who will be responsible for subjects' care, will be considered as HCPs in this trial.
This is a phase 1 study to assess safety and tolerability of intramuscular administration of two different doses of autologous bone marrow mononuclear cells (BM-MNCs) for treatment of lower extremity injury complicated by compartment syndrome injury.
The aim of this trial is to investigate the effectiveness of a mobile health (mhealth) intervention to help overweight and obese women achieve appropriate gestational weight gain (GWG) for their pre-pregnancy body mass index (BMI). The goal of the intervention is to help women achieve GWG within the range recommended by the Institute of Medicine. The investigators propose an adaptive intervention that begins with an effective, yet low resource-intensive treatment and then provides incremental support and resources only to patients who need them. The intervention includes: 1) an mHealth tool allowing data to be automatically transmitted to a mobile website; 2) personalized text messages; and 3) personalized 1:1 telephone coaching sessions. The latter more intensive components are reserved for patients whose GWG is not within the IOM guidelines. The lifestyle intervention will be delivered through 1 telephone counseling session with a study dietician trained in motivational interviewing techniques, as well as through technology-based tools, automated text messages and weekly e-mails of core lifestyle intervention sessions. Personalized text messages and 1:1 telephone coaching sessions will be given to those who are not meeting the GWG guidelines. The lifestyle intervention will be compared to usual medical care. Maternal outcomes will be assessed shortly before delivery and at 6 weeks postpartum. Infant birthweight and weight at one year will also be assessed.
This phase II trial studies olaparib and temozolomide in treating patients with uterine leiomyosarcoma (LMS) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), that has spread from where it first started to other places in the body (metastatic) or cannot be removed by surgery (unresectable). PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving olaparib and temozolomide may work better than giving either drug alone in treating patients with LMS.
This study is to be performed as an open label, multicenter, single arm study of 2X-121 to evaluate anti-tumor efficacy of 2X-121 as single agent therapy in a 28-days cycle in advanced ovarian cancer patients. 2X-121 will be supplied for oral administration twice daily as 600 mg (3 x 200 mg) capsules in a 28 days cycle. Patients with predicted high likelihood of responding to the drug (2X-121) using drug response prediction (DRP®), will be included in the study.