Jan 12th, 2022 - 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...

Jan 14th, 2022 - Objective: The goal of this protocol is to understand how the pathology of multiple sclerosis (MS) relates to its evolution over time as observed through neuroradiological, clinical, and biological data collection in vivo. Study population: This study will enroll up to 150 individuals with MS, targeting 50 study completers, across various ages and stages of the disease, as well as 50 appropriat...

Jan 14th, 2022 - PRIMARY OBJECTIVE: I. To demonstrate that anti-PD-1 therapy in combination with carboplatin/weekly paclitaxel results in improved progression free survival (PFS) versus systemic chemotherapy alone. SECONDARY OBJECTIVES: I. To demonstrate that anti-PD-1 therapy in combination with carboplatin/weekly paclitaxel results in improved overall survival (OS) versus systemic chemotherapy alone. II. To d...

Jan 14th, 2022 - The purpose of this study is to assess the safety and tolerability of the investigational product, SBI-101, in subjects with an infectious etiology of Acute Kidney Injury (AKI). SBI-101 is a biologic/device combination product designed to regulate inflammation and promote repair of injured tissue using allogeneic human mesenchymal stromal cells. SBI-101 will be integrated into the renal replace...

Jan 14th, 2022 - Neuroendocrine tumors vary widely in both disease site and grade, ranging from low grade, relatively benign carcinoid tumors to aggressive and rapidly fatal high-grade neuroendocrine carcinomas. High-grade neuroendocrine carcinomas (HG-NECs) can originate anywhere in the body, and are highly aggressive, with dismal 5-year overall survival rates. The lung and gastrointestinal tract (small bowel,...

Jan 14th, 2022 - The goal is to provide health care professionals, including dentists, with the best possible evidence for clinical decision making when deciding upon analgesics for acute post-surgical pain management, a double-blind, stratified randomized clinical trial will be conducted to test the hypothesis that a combination of over-the-counter non-opioid containing analgesics is at least as, if not more, ...

Jan 14th, 2022 - This is an open-label, multicenter Phase I/IIa dose escalation, safety, pharmacokinetic (PK) and pharmacodynamic (PD) trial of BNT151 with expansion cohorts in various solid tumor indications. The trial consists of Part 1, Part 2A and Part 2B with adaptive design elements: The monotherapy dose escalation (Part 1) of this clinical trial will enroll patients with various solid tumors that are met...

Jan 14th, 2022 - The primary purpose of Stage-I of this study is to evaluate the safety and tolerability of OP-101 in patients with severe COVID-19 and of Stage 2 of this study is to evaluate the efficacy of OP-101 in patients with severe COVID-19. The secondary purpose of Stage 1 and Stage 2 of this study is to determine the effect of OP-101 reducing proinflammatory cytokines biomarkers in severe COVID-19 Pati...

Jan 14th, 2022 - Several studies highlight how patients diagnosed with a digestive tract cancer, experience difficulties in returning to work after treatment, leading to socio-economic spill-over effects. A specific 16 questions questionnaire had been developed for this study, the "Health and Employment After Gastro Intestinal Surgery Dialogical Questionnaire" (HEADS-DQ). It investigate peculiar patient compete...

Jan 14th, 2022 - PRIMARY OBJECTIVE: I. To determine the feasibility of an intensive (systolic blood pressure [SBP] < 120 mmHg) "Intervention" versus standard care (SBP < 140 mmHg) "Non-Intervention" approach to blood pressure (BP) control in metastatic renal cell and thyroid cancer patients initiating anti-angiogenic tyrosine kinase inhibitors. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients re...

Jan 14th, 2022 - This is a prospective, multi-center, open label, phase II study with a window of opportunity component in patients with recurrent squamous cell carcinoma of the head and neck (SCCHN) treated with adjuvant pembrolizumab following salvage surgery. Forty-five (45) patients will participate in this study to determine disease-free survival probability at 12 months. Secondary objectives include asses...

Jan 14th, 2022 - Patients will be treated as standard of care, no randomization schedule, no blinded investigational product (IP). The decision which DOAC will be given is made before the subject will enter the trial. The DOAC has to be taken at least for seven days. The registry is non-interventional (NIS) with routine blood draw at baseline and at month 4 after inclusion. The prospective follow up will be up ...

Jan 14th, 2022 - In patients with scar in the hearts after heart attacks, the risk for dangerous abnormal heart rhythms, including sudden death is high. This is because dead muscle fibers are replaced by scar tissue, creating a physiological condition promoting abnormal heart rhythms.These abnormal heart rhythms are called ventricular arrhythmias or ventricular tachycardias. In these patients, ablation procedur...

Jan 14th, 2022 - The duration of each participant's participation in the study is approximately 7 months (28 day-vaccination period followed by 6 month safety follow-up period).

Jan 14th, 2022 - This is a Phase II study in 240 ED patients, which consists of 3 part: 1) a 4-week run-in period without any ED treatment; 2)randomization to 8 weeks of treatment with TPN171H or placebo; and 3) a 1-week follow-up period for continued adverse event monitoring. The effects of TPN171H on ED will be evaluated using the IIEF-EF and SEP diaries. The IIEF-EF will be administered at baseline and at 4-...

Jan 14th, 2022 - Design: Randomized controlled pilot trial, two parallel groups, blinded outcome assessment. Eligibility Criteria: Inclusion criteria include a) adult patients within a day of their hospital discharge from internal medicine services with a discharge prescription for an OAC intended to be taken for at least 4 weeks, b) discharge is to home or to a congregant setting such as retirement home where ...

Jan 14th, 2022 - This is an open-label single arm study investigating the safety and feasibility of an intravenous loading regimen of sotalol to initiate patients on oral sotalol therapy. Informed Consent will be obtained from all patients prior to enrollment in the study. Patients will be admitted to the hospital in accordance with standard hospital protocol for oral sotalol loading.

Jan 14th, 2022 - The main purpose of this study is to describe the safety and tolerability of 80 weeks of subcutaneous (SC) evolocumab when added to standard of care in children 10 to 17 years of age with familial hypercholesterolemia.

Jan 14th, 2022 - HIV prevalence among incarcerated youth living with HIV (YLWH) is three times that of the general population and one in seven of all HIV+ persons experience incarceration each year. Furthermore, only an estimated 6% of HIV+ youth achieve HIV viral load suppression, due to poor retention and adherence to anti-retroviral therapy (ART). Existing linkage and retention services are insufficient to m...

Jan 14th, 2022 - Study duration per participant is 2 months to estimated 16 months. Cycle lengths in this study are 27 days in Cycle 1 and 28 days for subsequent cycles as determined by totality of data collected thus far including PK/Pharmacodynamics (PD), safety and preliminary efficacy.

Jan 14th, 2022 - Patient randomization will be stratified based on patient's location (Memphis vs. other), use of antihypertensives prior to randomization, and factors known to influence osteonecrosis risk, specifically sex and self-declared race (non-Hispanic white vs. other). A target systolic blood pressure range will be chosen for each participant based on their randomization arm, age, sex, and height. Pati...

Jan 14th, 2022 - This is an observational pilot study comparing triamcinolone acetonide injections with the investigational Med-jet needle-free drug-delivery system as an alternative to using a conventional syringe and needle in patients with mild-to-moderate psoriasis. There will be five (5) visits necessary for study participation. The hypothesis is that the efficacy, safety, pain tolerance, and quality of li...

Jan 14th, 2022 - The ASCEND trial is a multi-center, multiple dose (PRN), open-label, 12-month study to evaluate the safety and tolerability of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine.

Jan 14th, 2022 - This open label Phase 1 multicenter study is designed to evaluate the safety and maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SAR442720 in combination with pembrolizumab in participants with solid tumors in Part 1. In Part 2, in the expansion cohort (Cohort A) we will assess the antitumor activity and safety of SAR442720 combined with pembrolizumab in participants with me...

Jan 14th, 2022 - The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination of parsaclisib and ruxolitinib in subjects with myelofibrosis.

Jan 14th, 2022 - Design: This first-in-human, open-label study will evaluate CAP256V2LS (VRC-HIVMAB0102-00-AB) in healthy adults. The primary hypothesis is that subcutaneous (SC) and intravenous (IV) administrations of CAP256V2LS will be safe and well-tolerated in healthy adults. A secondary hypothesis is that CAP256V2LS will be detectable in human sera with a definable half-life. Study Product: The CAP256V2LS ...

Jan 14th, 2022 - This study is a phase IIb, multicenter, multi-national, double-blind, randomized, parallel-arm, placebo-controlled study to evaluate the effect of 5 dose levels of CSJ117 (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to standard of care asthma therapy in adult subjects with inadequately controlled asthma despite medium to high dose ICS plus LABA. Approximately 625...

Jan 14th, 2022 - Backgroud & Aim:Hepatectomy is the main way to treat all kinds of liver surgical diseases, which can be divided into anatomic hepatectomy and non-anatomic hepatectomy.Among them, anatomic hepatectomy is suitable for primary liver cancer, hepatolithiasis and other benign and malignant diseases;It can be divided into hepatic venous guidance and non-hepatic venous guidance hepatectomy (traditional...

Jan 14th, 2022 - There are two primary objectives in this study. The first objective is to refine the investigators previously developed general sexual risk reduction intervention (SexHealth II) to focus on patient-centered contraception counseling and initiation for hospitalized female adolescents. The second objective is to conduct an open trial to assess feasibility of the investigators SexHealth II interven...

Jan 14th, 2022 - This is a Phase 3, multicenter, randomized, double-blinded, placebo-controlled study to assess the efficacy, safety, and immunogenicity of RSVpreF or placebo (1:1 randomization) in infants born to healthy women vaccinated during pregnancy, as well as the safety and immunogenicity in the pregnant women. This will be a global study which will span multiple RSV seasons.

Jan 14th, 2022 - A study designed to evaluate the non-inferiority of crovalimab compared with eculizumab in participants with PNH who have not been previously treated with complement inhibitor therapy. This study will enroll approximately 200 participants.

Jan 14th, 2022 - The study is a prospective, subject-blinded investigation of whether implanting capsular tension rings with intraocular lenses affects rotational stability of the lens. Lens Selection: The patients will undergo standard of care preoperative measurements and planning. The surgeon will evaluate preoperative measurements and use lens calculations, as well as a discussion with the patient, to ident...

Jan 14th, 2022 - The purpose of the study is to demonstrate the long-term safety, tolerability and efficacy of bimekizumab in patients with active axial spondyloarthritis (axSpA, also known as radiographic axSpa (r-axSpA)) including ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpa).

Jan 14th, 2022 - This is a randomized, multicenter, open-label, two-arm, Phase II study to evaluate the efficacy, safety, and pharmacokinetics of giredestrant versus anastrozole (in the window-of-opportunity phase) and giredestrant plus palbociclib compared with anastrozole plus palbociclib (in the neoadjuvant phase) in postmenopausal women with untreated, estrogen receptor (ER)-positive, human epidermal growth...

Jan 14th, 2022 - This is a multicenter, open-label, Phase 2 study to assess the efficacy and safety of tazemetostat in participants with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) with EZH2 gene mutation.

Jan 14th, 2022 - This is a Phase 1/2, open-label, multicenter, sequential dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of ZN-e4 administered orally in subjects with advanced non-small cell lung cancer (NSCLC) with activating EGFR mutations who have progressed while on treatment with an EGFR tyrosine kinase inhibitor (TKI) agent (other lines of treat...

Jan 14th, 2022 - The purpose of this study is to determine whether BMS-986258 both monotherapy and in combination with Nivolumab is safe and tolerable in the treatment of advanced malignant tumors.

Jan 14th, 2022 - This is a single institution, prospective, phase I/II open-label study in a maximum of 20 patients evaluating a novel treatment strategy in NDMM patients with high-risk disease who do not have a 6/6 compatible sibling donor. Participating patients will be from Hôpital Maisonneuve-Rosemont (HMR) or referred to HMR for this protocol. Newly diagnosed multiple myeloma patients will be evaluated for...

Jan 14th, 2022 - Approximately 50% of Pima Indian children from diabetic pregnancies develop T2DM by age 25. Since intrauterine exposure to diabetes leads to a higher risk of diabetes in the offspring, the risk might be greatly diminished by preventing diabetes during pregnancy or ameliorating its effects. Standard prenatal and obstetrical care has not been able to abolish this excess risk in the Pima Indians, ...

Jan 14th, 2022 - PRIMARY OBJECTIVES: I. To select the better docetaxel-based experimental arm to improve disease-free survival (DFS) over the control arm of radiation and cisplatin. (Phase II) (COMPLETE AS OF 20-MAR-2020) II. To determine if the combination of docetaxel-cetuximab and intensity-modulated radiation therapy (IMRT) is superior in terms of overall survival (OS) compared to standard cisplatin and IMR...

Jan 14th, 2022 - The purpose of this study is to investigate neuromodulation as new approach to enhance rehabilitation for people who have upper limb movement impairment after neurological injury such as stroke or spinal cord injury. Emerging evidence demonstrates that animals and people can exert control over the level of excitability in neural pathways that contribute to movement. This discovery has important...

Jan 14th, 2022 - This is a single-institution phase II trial of Durvalumab combined with Radiation Therapy (RT) for metastatic pancreatic cancer patients who have progressed through first-line chemotherapy. Pancreatic cancer patients who have received second-line or greater chemotherapy in the metastatic setting are not eligible. Target accrual is 39 patients. Durvalumab 1500 mg (or 20 mg/m2 if <30 kg) IV every...

Jan 14th, 2022 - Intensive treatment of Acute Leukemia, multidrug based chemotherapy induction, achieves complete remission (CR) rates ranging from 50% to 80%. Nonetheless, the majority (60- 70%) of responding patients will eventually relapse. Patients with non-low risk leukemia according most diffuse risk scores have a poor prognosis and a short survival. For these patient traditional chemotherapy seems to be ...

Jan 14th, 2022 - This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events [MACE - cardiovascular (CV) death, myocardial infarction (MI), and stroke] in subjects with acute coronary syndrome (ACS) diagnosed with either ST-segment elevation myocardial infarction (STEMI) or non-ST...

Jan 14th, 2022 - Objective: Despite recent advances in addiction neuroscience, achieving a breakthrough in predicting addiction treatment outcome has been difficult and long-term abstinence success unacceptably low. The aim of this study is to create a biomarker using various neuroimaging metrics that can predict treatment outcome in opioid, alcohol and dual opioid and alcohol use disorder patients. Study Popul...

Jan 14th, 2022 - Following cast application, little is known regarding the need to split the cast, either in a univalve (a split along a single side of the cast) or bivalve (a split along both sides of the cast) fashion. Theoretically, the splitting of the cast allows for expansion and soft tissue swelling. However, review of the literature yields a paucity of evidence demonstrating the efficacy of splitting a ...

Jan 14th, 2022 - This is a Phase 1/2a, open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of PF-06873600 administered as a single agent in sequential dose levels and then in combination with endocrine therapy. In Part 1A and Part 1C, successive cohorts of patients will receive escalating doses of PF-06873600 and then in dose finding (Part 1B...

Jan 14th, 2022 - The drug being tested in this survey is called leuprorelin acetate injection kit 11.25 mg. This injection kit is being tested to treat people who have SBMA. This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the leuprorelin acetate injection kit 11.25 mg in the routine clinical setting. The planned number of observed patients will be...

Jan 14th, 2022 - The purpose of this multicenter double blind study is to assess efficacy and safety of Pitolisant versus placebo in paediatric Narcoleptic patients with or without cataplexy.

Jan 14th, 2022 - Evaluate the safety and tolerability of AMG 562 in adult subjects with DLBCL, MCL, or FL. Estimate the maximum tolerated dose (MTD) and/or a biologically active dose (e.g., recommended phase 2 dose [RP2D])