Sep 24th, 2021 - OUTLINE: Patients who have one or more elevated distress or low cardiometabolic or cancer health care adherence are randomized to Arm I or II. Patients who do not have elevated distress or low cardiometabolic or cancer health care adherence are assigned to Group 0. ARM I (INTERVENTION): Patients receive a personalized smart cell phone (SCP) and use the Interactive Survivorship Program to Improv...

Sep 24th, 2021 - The primary objective of this study is to assess the safety and tolerability of escalating IM doses of ADM03820 in healthy adults. Secondary objectives include assessing the pharmacokinetic characteristics and immunogenicity.

Sep 24th, 2021 - Blinded Phase: Participants will receive blinded study drug (Donafenib/placebo) in 2:1 ratio until documentation of disease progression (confirmed by independent imaging review committee), development of unacceptable toxicity, or withdrawal of consent. After having completed the primary analysis, subjects treated with Donafenib who have not experienced disease progression may request to continu...

Sep 24th, 2021 - Malaria caused by Plasmodium falciparum continues to be a global problem with devastating consequences, in particular for at-risk populations such as pregnant women and young infants. Pregnancy malaria is associated with low birth weight (LBW), maternal anemia, and gestational hypertension; both inflammation and the fetal response to infection may contribute to these poor outcomes. Placental ma...

Sep 24th, 2021 - This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is either persistent or recurrent following adequate BCG induction (Cohort A), or that is naïve to BCG treatment (Cohort B). The primary hypothesis for Cohort A is that the combination of pembrolizumab plus BCG has a superio...

Sep 24th, 2021 - PRIMARY OBJECTIVES: I. Compare the relative efficacy of tai chi and strength training to prevent falls in female cancer survivors. II. Determine the mechanism by which tai chi and strength training each reduces the risk of falls. III. Determine how well the benefits of each intervention persist after structured training stops. SECONDARY OBJECTIVE: I. Evaluate the effect of the intervention on p...

Sep 24th, 2021 - [Trial of device that is not approved or cleared by the U.S. FDA] - Full Text View.

Sep 24th, 2021 - This is a pilot study of an oral drug Ramipril to prevent cognitive decline in glioblastoma patients receiving partial brain radiation and concurrent and adjuvant temozolomide . Ramipril will be titrated to the highest tolerable dose during chemoradiation (2.5-5 mg). Once this dose is determined, the patient will continue at this dose for 4 months after the completion of chemoradiation. Patient...

Sep 24th, 2021 - This study evaluates the efficacy of intra-articular administration of RegenoGel-OSP™ and RegenoGel™ to treat knee pain and effect on subject's activity and quality of life. During the study the subjects will receive two treatments at a 3-month interval. The study is double-blinded. The subjects will be randomized and sequentially assigned to RegenoGel-OSP™, RegenoGel or placebo treatment in th...

Sep 24th, 2021 - The main purpose of this study is to assess preliminary efficacy and safety of LYS006 in patients with moderate to severe inflammatory acne and to determine if LYS006 has an adequate clinical profile for further clinical development.

Sep 24th, 2021 - Multiple myeloma（MM） is one of the most common malignant diseases in the blood system.There is still no cure for the disease which only control the development of the disease in various ways. In recent years, the understanding of pathogenic molecular mechanism in MM , many new types of drugs can be used in the treatment of this disease, one of the most widely used is proteasome inhibitors and...

Sep 24th, 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.

Sep 24th, 2021 - This is a randomized, double-blind, placebo-controlled study in patients with dilated cardiomyopathy (DCM) due to a mutation of the gene encoding the lamin A/C protein (LMNA). The study will further evaluate a dose level of study drug (ARRY-371797) that has shown preliminary efficacy and safety in this patient population. After the primary analysis has been performed, eligible patients may rece...

Sep 24th, 2021 - Extranodal natural killer/T-cell lymphoma (ENKTL) generally has poorer prognosis than other lymphomas because the majority of patients are present as advanced disease and show poor response to treatment. In particular, treatment of relapsed or refractory stage ENKTL is very poor and there is no standard treatment. ENKTL is entirely infected with Epstein-Barr virus (EBV) and the prevalence of th...

Sep 24th, 2021 - The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who roll-over into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will roll-over to this extension study in one o...

Sep 24th, 2021 - This is a multi-center, prospective, non-interventional study. The study will enroll about 1700 Chinese patients diagnosed as NSCLC and treated with osimertinib at least one dose. The investigator in an observational study cannot intervene in the treatment. The prescribing doctor is in charge of prescribing or discontinuation of osimertinib. It is planned that all eligible patients who received...

Sep 24th, 2021 - The overall goal of this project is to understand the mechanisms by which gastric bypass surgery improves glucose metabolism. The central hypothesis guiding this project is that the reconfiguration of intestinal transit with the Roux-en-Y will increase the release of insulinotropic GI hormones, termed incretins that improve insulin secretion and glucose metabolism. The study is divided into thr...

Sep 24th, 2021 - Study Design A prospective randomized double blind study will be conducted to assess the effect of a single preoperative dose of gabapentin on postoperative opioid consumption within the first 72 hours when compared to oral placebo in patients undergoing rhinoplasty at The Ohio State University Wexner Medical Center. Preoperative Period After assessing patients' eligibility on the day of the su...

Sep 24th, 2021 - This study will compare the efficacy and safety of molecularly-guided therapy versus standard platinum-containing chemotherapy in participants with poor-prognosis cancer of unknown primary site (CUP; non-specific subset) who have achieved disease control after 3 cycles of first-line platinum based induction chemotherapy.

Sep 24th, 2021 - The sponsor and the study steering committee decided to prematurely stop enrollment of subjects to Arm 1 after data review showed an increased treatment discontinuation rate due to progressive disease in Arm 1 as compared to Arms 2 and 3 (both containing Carboplatin).