Dec 3rd, 2021 - The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected...

Dec 3rd, 2021 - This is a randomized (individuals assigned to study treatment by chance), double-blind (individuals and study personnel will not know the identity of study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study in approximately 400 adult participants with follicular lymphoma or marginal zone lymph...

Dec 3rd, 2021 - The study is multi-center, prospective, double-blind, randomized (3:1) controlled trial. GUIDE XT may be used for planning of programming as needed.

Dec 3rd, 2021 - As the pediatric obesity epidemic continues to rise, obesity-associated pathologic conditions, such as type II diabetes, hypertension and gastroesophageal reflux disease (GERD), become more prevalent, which, in turn, creates a need for a better understanding of the impact of obesity on drug disposition and response in pediatric patients with obesity. The following proposal is designed to addres...

Dec 3rd, 2021 - EINSTEIN PE study demonstrated that rivaroxaban is at least as effective as the current standard therapy with 51% relative risk reduction of major bleeding (1.1% vs. 2.2%, HR 0.49, 95% CI, 0.31-0.79), in the treatment and secondary prevention of PE. However these patients were required to meet strict eligibility criteria. Little is known about PE treatment in China in routine clinical practice ...

Dec 3rd, 2021 - The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of brivaracetam (BRV) administered intravenously (iv) in subjects >= 1 month to < 16 years of age with epilepsy.

Dec 3rd, 2021 - The purpose of this study is to evaluate both the safety and tolerability of up to 4 dosing cycles of TAR-200 for 21 days per dosing cycle in the induction period.

Dec 3rd, 2021 - The investigators plan to leverage the Way to Health (WTH) platform to develop and evaluate a new HTN service-delivery model that is integrated with routine clinical care at Penn Family Care (PFC), an academic family medicine practice in West Philadelphia. Among patients with poorly controlled HTN: The investigators will assess the effects of monitoring blood pressure and medication adherence w...

Dec 3rd, 2021 - PRIMARY OBJECTIVES: I. Assess the safety of infusing ex vivo expanded natural killer (NK) cells in patients receiving busulfan-fludarabine phosphate (fludarabine) with an allogeneic human leukocyte antigen (HLA) matched hematopoietic transplantation for myeloid malignancies. Two sources of NK cells could be studied, depending on what donor source is available: cells from the HLA matched related...

Dec 3rd, 2021 - The purpose of this observational study is to evaluate the performance and safety of endovascular treatment with stenting (Optimed Sinus Superflex 635 or Qualimed Pontos-pp) or balloon angioplasty (Cardionovum Legflow or Optimed Nylotrack .035 + .018) according to current practice. The goal of the study will be achieved by assessing binary restenosis with duplex ultrasound, peri- and postoperat...

Dec 3rd, 2021 - This is an open-label (both [participants and investigator] know what treatment participants will receive) and multicenter study. The study is divided into 2 parts: Part 1: pharmacokinetics portion (Week 0 to Week 14); Part 2: study extension (Week 14 to Week 114). The focus of this study is to evaluate the pharmacokinetics and safety of golimumab. Additionally the efficacy of short-term therap...

Dec 3rd, 2021 - The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery. The following tumor types are included in this study: Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cel...

Dec 3rd, 2021 - This Phase 3 clinical trial is an essential step in the evaluation of an investigational medication to see if it may be useful in treating prostate cancer. The purpose of the SPARTAN study is to compare the safety and effectiveness of the investigational medication to placebo in delaying prostate cancer from spreading to other parts of the body. A placebo is a pill that looks like the investiga...

Dec 3rd, 2021 - Pilot feasibility trial in preparation for RCT. Adolescents aged 14-18 will be recruited for screening from community-based primary care clinics to ensure ease of dissemination and representation of community-based primary care settings. The primary goal is to develop feasibility to apply for an R01 to conduct an RCT. Power analyses indicate that 280 participants would be needed for an RCT afte...

Dec 3rd, 2021 - Japan PMDA has approved enfortumab vedotin (Padcev) for the treatment of advanced urothelial cancer. The study will continue as a post marketing study in Japan. Participants considered an adult according to local regulation at the time of obtaining informed consent participated in the study.

Dec 3rd, 2021 - The purpose of this study is to evaluate efficacy of ibrutinib in Japanese participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall cGVHD response (complete response [CR] and partial response [PR] defined by National Institutes of Health [NIH] consensus development project criteria [2014]).

Dec 3rd, 2021 - Rationale: The published clinical trials investigating the bronchoscopic lung volume reduction, showing important patient-related improvements in efficacy, led to the acknowledgement of the treatment in the GOLD-COPD2017 guidelines. Interaction with pulmonary rehabilitation, impact on patient-reported outcomes, physical activity, and extrapulmonary consequences are all topics to gain more insig...

Dec 3rd, 2021 - This study is designed to assess the safety of baked milk oral immunotherapy among patients who are milk allergic and who do not pass a baked milk challenge.

Dec 3rd, 2021 - The hypothesis is treatment with combination of I+VEN will result in longer PFS compared with G-Clb in participants with previously untreated chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) who meet International Workshop on CLL (iwCLL) treatment criteria. The study includes screening (30 days), treatment (from randomization until treatment discontinuation) and follow-up ph...

Dec 3rd, 2021 - The investigators propose a two-arm cluster randomized controlled design, in which the unit of randomization is the clinician. Up to fifty cardiology clinicians will be randomly assigned to either the coaching intervention or to a control condition. The investigators will recruit up to 50 clinicians to ensure that we have at least 40 clinicians with complete pre- and post-intervention measures....