Jan 31st, 2023 - The purpose of this protocol is to study the natural history of spondyloarthritis (SpA) in children and adults. Spondyloarthritis encompasses a spectrum of immune-mediated inflammatory diseases that exhibit overlapping features, but differ from other types of inflammatory arthritis in genetic predisposition, pathogenesis, and outcome. Ankylosing spondylitis (AS), the most common form of SpA, fr...

Feb 3rd, 2023 - The purpose of this study is to better understand what types of transitions people with pancreatic cancer face when they receive chemotherapy. Again, this study defines transition as a change in a life situation or a status that causes a change in a person's identity, role, behavior, or personal relationships. Examples of transitions include changes in sleeping habits, anxiety, employment, rela...

Feb 3rd, 2023 - Background: Hereditary Diffuse Gastric Cancer (HDGC) is most often attributed to inactivating germline mutations in the E-cadherin (CDH1) tumor suppressor gene. Mutation carriers have a 24-70% lifetime risk of developing gastric adenocarcinoma. International consensus guidelines recommend endoscopic screening and surveillance of CDH1 mutation carriers who decline risk-reducing total gastrectomy...

Feb 3rd, 2023 - This study aims to prove that emerging CT-based tools are suitable to measure changes in central and peripheral bone density, geometry, micro-structure, and marrow adipose tissue (MAT) among patients treated with oral steroids. To do this, investigators will recruit 10 non-smokers (defined as < 10 pack-year smoking history) age 25-45 years with a diagnosis of severe, persistent asthma who eithe...

Feb 3rd, 2023 - Study Design Introduction:This will be a parallel design cluster randomized controlled trial with 3 years (3 seasons) of follow-up from initial deployment of mosquitoes. The intervention will be routine control measures, as recommended by the Brazilian National Control Program (larvicide using PPF at individual house visits at least 4 times a year), in the presence or absence of the deployment ...

Feb 3rd, 2023 - The primary aim of this prospective study is to investigate if cfDNA in plasma is feasible and reliable for selection of mCRC patients who will benefit of anti-EGFR monoclonal antibody therapy Secondary, to analyze developments in mutational status as reflected by cfDNA in plasma during therapy and at time of progression

Feb 3rd, 2023 - PRIMARY OBJECTIVE: I. To compare bladder intact event-free survival (BI-EFS) for concurrent chemoradiation therapy (CRT) with and without atezolizumab in localized muscle invasive bladder cancer (MIBC). SECONDARY OBJECTIVES: I. To compare overall survival between the two arms. II. To compare modified bladder intact event-free survival including cancer related death between arms. III. To compare...

Feb 3rd, 2023 - The purpose of this study is to evaluate if the combination of nivolumab and a CCR2/CCR5 dual antagonist (BMS-813160) with GVAX is safe in patients with locally advanced pancreatic cancer (LAPC) who have received chemotherapy and radiotherapy, and to see if this combination therapy enhances the infiltration of CD8+CD137+ cells in PDACs .

Feb 3rd, 2023 - This is a local, non-interventional, multi-center, single-cohort study using primary data of patients treated with Xofigo for the indication of castration resistant prostate cancer (CRPC) with bone metastases. A total of 300 patients (valid for safety analysis) are enrolled within 18 months. During the observation period (i.e. up to 6 months), safety and effectiveness information is collected. ...

Feb 3rd, 2023 - Study Description: It may be in the interest of the NIDCD Clinical Research Program (CRP) to collect clinical data or specimens generated in the diagnosis and treatment of head and neck or communication disorders and to evaluate patients to determine candidacy for intramural clinical studies. This protocol will provide the administrative vehicle to enable the evaluation and provision of clinica...

Feb 3rd, 2023 - PRIMARY OBJECTIVE: I. To compare the invasive disease-free survival (IDFS) of patients with inflammatory breast cancer receiving concurrent administration of olaparib with standard doses of radiotherapy to the chest wall and regional lymph nodes compared to standard doses of radiotherapy alone to the chest wall and regional lymph nodes. SECONDARY OBJECTIVE: I. To compare the effect of concurren...

Feb 3rd, 2023 - Molecular genetics has the potential to revolutionize the diagnosis and treatment of inherited eye diseases. Progress in research on inherited eye disease would be augmented by the availability of patient DNA coupled to robust, anonymous phenotypic information. The National Ophthalmic Genotyping and Phenotyping Network (eyeGENE(R)) has been created to answer this need. By creating a national DN...

Feb 3rd, 2023 - The investigators will perform an RCT with a 12-week delayed start control group in 224 dyads of PWMLs and CGs. The primary outcome in PWML will be self-rated quality of life (Quality of Life in Alzheimer's Disease, QOL-AD). Secondary outcomes will include: a) self-reported emotional well-being; b) self-reported social isolation; c) self-reported mobility; and d) directly assess cognitive perfo...

Feb 3rd, 2023 - This is a multicenter, open-label study in adult patients with PA to evaluate the effectiveness and safety of CIN-107 after up to 12 weeks of treatment, at doses from 2 to 8 mg per day, for the management of blood pressure in patients with primary aldosteronism (PA).

Feb 3rd, 2023 - This study is a randomized, 12-month follow up clinical trial. According to sample size calculation, ten patients will be selected in conjunction with departments of Pedodontics and Crowns & Bridges. The study will be conducted in accordance with the principles of the Research Ethics Committee, Faculty of Dental Medicine for Girls, Al-Azhar University, Egypt. The purpose of the investigation an...

Feb 3rd, 2023 - The purpose of this study is to compare overall survival (OS) and progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR). Hypothesis (H1): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone wi...

Feb 3rd, 2023 - The vaccine will be administered orally (by mouth) as a solution mixed with sodium bicarbonate. Approximately 10 minutes prior to receiving the vaccine, participants will take sodium bicarbonate pills to assist with the absorption of the vaccine. Participants may be pre-treated with acetaminophen (Tylenol) and diphenhydramine (Benadryl). Acetaminophen (Tylenol) and diphenhydramine (Benadryl) ar...

Feb 3rd, 2023 - This is a 114-week,randomized, multicenter, double-blind, parallel-group, active-control study with an open-label extension period of up to 156 weeks, for a total duration of up to 270 weeks in patients with IgAN who have persistent overt proteinuria and remain at high risk of disease progression despite being on a stable dose (or doses) of an angiotensin-converting enzyme inhibitor (ACEI) and/...

Feb 3rd, 2023 - PRIMARY OBJECTIVES: I. To compare the efficacy of single-agent olaparib and the combination of olaparib and cediranib (and potentially other combination arms that may be added by subsequent amendment) versus single agent cediranib as measured by progression free survival (PFS), in patients with recurrent, persistent or metastatic endometrial cancer. II. To compare the efficacy of the combinatio...

Feb 3rd, 2023 - Objective The broad objective of this study is to determine the relationship between variations in genes related to dopamine (DA) neurotransmission in areas of the brain associated with motor leaning (e.g. DRD1, DRD2, DRD3, COMT, DAT) and/or to activity-dependent brain plasticity (e.g. BDNF) and differences in motor learning rates and cognitive processing abilities in persons with and without c...