Oct 14th, 2022 - This is randomized controlled trial to determine the efficacy of autologous, micro-fragmented adipose tissue (MFAT) injection under ultrasound guidance for chronic, nonresponsive shoulder pain due to rotator cuff disease (i.e., rotator cuff tendinopathy) in persons with spinal cord injury (SCI). The control for this study, to which MFAT will be compared, is corticosteroid injection into the sub...

Oct 14th, 2022 - The primary objective is to assess the safety of intravitreal aflibercept injections in patients with wet age-related macular degeneration (wAMD), myopic choroidal neovascularization (mCNV), diabetic macular edema (DME), macular edema secondary to central retinal vein occlusion (CRVO) or macular edema secondary to branch retinal vein occlusion (BRVO). Secondary objectives comprise the compariso...

Oct 14th, 2022 - Objectives: The primary objective is to assess if there is disruption of circadian DA rhythms in cocaine addiction. The secondary objective is to assess if dopamine modulates the sensitivity of the brain reward network in a circadian dependent manner. Study Population: Non-treatment seeking cocaine abusers (moderate or severe cocaine use disorder as per DSM-IV or DSM 5) and healthy controls. Ma...

Oct 14th, 2022 - Background: Irinotecan is a prodrug of an inhibitor of topoisomerase 1 (active metabolite is SN-38) with known activity in sarcomas, however it has limitations including suboptimal bioavailability and systemic side effects including severe diarrhea and bone marrow suppression. Preclinical and clinical evidence has demonstrated that prolonged exposure to topoisomerase 1 inhibition produces super...

Oct 14th, 2022 - The purpose is to evaluate the efficacy and safety of the combination of capmatinib with pembrolizumab compared to pembrolizumab alone as first-line treatment for subjects with locally advanced or metastatic NSCLC who have PD-L1 expression ≥ 50% and have no EGFR mutation or ALK rearrangement. Capmatinib has demonstrated immunomodulatory activities when combined with an anti-PD1 antibody in prec...

Oct 14th, 2022 - The drug being tested in this study is called modakafusp alfa (TAK-573). Modakafusp alfa is being tested to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity as single agent (SA) or in combination with pembrolizumab in participants with locally advanced or metastatic solid tumors. The study will consist of 2 phases: Phase 1b dose escalation and a...

Oct 14th, 2022 - Tamoxifen Selective estrogen receptor modulator It has been the main endocrine treatment for decades Tamoxifen is a major endocrine treatment option, particularly for women who still have a significant ovarian estrogenic activity that cannot be controlled by aromatase inhibitors. The prospective clinical trials have shown that tamoxifen 20mg has comparable efficacy against tamoxifen 40mg with f...

Oct 14th, 2022 - Over 7,000 people in the UK are living with Myelodysplastic Syndromes (MDS). Approximately 1,600 of these individuals (23%) die each year from their disease. MDS affects the production of blood cells by the bone marrow, causing chronic fatigue, bleeding, and recurrent infections. Many patients die because their disease transforms into acute myeloid leukaemia (AML) an even more aggressive blood ...

Oct 14th, 2022 - The morbidly obese bariatric surgery population is susceptible to opioid-induced complications such as respiratory depression and postoperative nausea and vomiting. This population may in particular benefit from opioid-sparing or opioid-free anesthetic techniques. This study aims to evaluate the effect of opioid free total intravenous anesthesia on postoperative quality of recovery in patients ...

Oct 14th, 2022 - This double-blinded, randomized study is being conducted to see if the investigational new drug called FP-1201-lyo - intravenous Interferon beta-1a, hereafter IV IFN beta-1a, can help patients recover more quickly from COVID-19 and prevent worsening of the condition. To understand if IV IFN beta-1a can help treat patients with COVID-19, this study drug will be compared to dexamethasone. Study s...

Oct 14th, 2022 - HHT is associated with substantial morbidity, leading to a reduced quality of life, decreased rate of employment and a high incidence of depression. There currently exists no medical therapy recognized as consistently efficacious in HHT. Reports of the efficacy of thalidomide in HHT, as well as interim results of a pilot trial of pomalidomide in HHT provide evidence of efficacy with minimal tox...

Oct 14th, 2022 - Primary Objectives: To determine the clinical efficacy of pembrolizumab combined with cetuximab for patients with R/M HNSCC. Cohort 1 (PD-1/PD-L1 inhibitor-naïve, cetuximab-naïve): clinical efficacy defined as overall response rate. Cohort 2 (PD-1/PD-L1 inhibitor-refractory, cetuximab-naïve): clinical efficacy defined as overall response rate. Cohort 3 (PD-1/PD-L1 inhibitor-refractory, cetuxima...

Oct 14th, 2022 - The aim of this randomized controlled trial is to examine the treatment of coronary bifurcation lesion with a sirolimus coated balloon versus a paclitaxel coated balloon. This trial is designed as prospective, multicenter, randomized and open-label.

Oct 14th, 2022 - This study consisted of a Screening period, conducted up to 4 months before randomisation, followed by three phases: a 16-week, double blind (DB), randomised, placebo-controlled phase; a 32-week initial open label (IOL) phase; and a long term open label extension (LTOLE) phase. The DB phase evaluated lanreotide Autogel versus placebo in subjects with a history of carcinoid syndrome (flushing an...

Oct 14th, 2022 - Rationale Adalimumab is both an effective induction and maintenance therapy for Crohn's disease (CD). Due to the risk of side effects (infections, injection reaction) and high costs, an extension of the injection interval is an attractive option. However, this strategy has not been evaluated yet in a randomized controlled trial in CD patients. Objective To assess non-inferiority and cost-effect...

Oct 14th, 2022 - This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes.

Oct 14th, 2022 - BACKGROUND: The proteasome inhibitor bortezomib and purine nucleoside metabolic inhibitor clofarabine demonstrated greater than additive activity in combination in preclinical xenograft models, justifying the clinical evaluation of this combination for its antitumor activity OBJECTIVES: To establish the safety, tolerability, and maximum tolerated dose (MTD) of bortezomib and clofarabine in pati...

Oct 14th, 2022 - Background: Smoldering multiple myeloma (SMM) is a precursor condition to MM defined by the clinical parameters of M-protein >=3.0 g/dL or bone marrow plasma cells >=10%, and absence of end organ disease. Patients with high-risk SMM have a risk of progression to MM of 72-75% in 5 years with median time to progression of <2 years. The current standard of care for SMM is close follow-up without t...

Oct 14th, 2022 - PRIMARY OBJECTIVE: I. Estimation of major pathological response (MPR) rate (=< 5% viable tumor cells). II. Assess the safety of combining immunotherapy (durvalumab and oleclumab) with gemcitabine/nab-paclitaxel as neoadjuvant therapy. EXPLORATORY OBJECTIVES: I. Explore the changes in various immune parameters, including PD-L1 and PD-1 expression in the tumor, during treatment and correlate with...

Oct 14th, 2022 - This trial is a prospective, observational Phase IV study is to understand the cancer management and health-related quality of life in patients with mRCC in routine real-world clinical practice in the United States, including both community and academic treatment settings. Primarily, the study will evaluate patient experience through collection of patient reported outcomes (PROs). The study wil...