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 - 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 - 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 - 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 - In particular the study aims to see if participants are asked about their smoking status and what services are offered if someone indicates being a former or current smoker. Findings from this study will help improve a standard of care at this clinic and allow us to understand what type of tobacco treatment services are preferred by patients. Adaption of CEASE will entail exit interviews with p...

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...

Feb 3rd, 2023 - Research Design and Methods Overview of Study Design & Procedure. The aim of this randomized controlled trial (RCT) is to determine the efficacy of a behavioral intervention targeting health communication skills and diabetes self-management skills in preparation for the transfer to adult diabetes care, compared to usual care. The intervention, Plan, Reflect, and Engage with Providers for Diabet...

Feb 3rd, 2023 - Neuromuscular weakness syndrome post intensive care is a generalized muscular weakness with amyotrophy caused by the stay in the intensive care unit. This pathology is frequent, under diagnosed, increases the length of stay and mortality in intensive care and alters the functional status in the long term (mobility, autonomy, cognitive abilities). The gold standard is the MRC score. It must be u...

Feb 3rd, 2023 - Esophageal atresia a congenital condition requiring surgical intervention. The most common configuration is Gross type C, proximal EA with distal TEF (EA/TEF). The operation for type C includes tracheoesophageal fistula closure and esophageal anastomosis creation. Although mortality has markedly decreased since the operation was first described, overall complication rate remains at 62%, with th...

Feb 3rd, 2023 - PRIMARY OBJECTIVE: I. To compare the overall survival (OS) in patients with metastatic renal cell cancer (RCC) treated with ipilimumab-nivolumab followed by either nivolumab versus cabozantinib-nivolumab. SECONDARY OBJECTIVES: I. To determine progression free survival (PFS) of patients treated with nivolumab versus nivolumab-cabozantinib. II. To evaluate the 12-month complete response rate in p...

Feb 3rd, 2023 - Sixty patients will be included in this prospective randomized study. The patients will be allocated into two groups: the ESPB group (group E, n = 30) and the tramal group (group T, n =30). All patients will receive standard general anesthesia. Ultrasound-guided ESPB will be performed to group erector spinae plane block

Feb 3rd, 2023 - The purpose of the study is to assess the efficacy of rozanolixizumab as measured by seizure freedom, change in cognitive function, use of rescue medication, onset of seizure freedom and to assess safety and tolerability.

Feb 3rd, 2023 - There are 5 parts to this study for which the primary objectives are to evaluate safety, tolerability, and pharmacokinetics (PK) of navitoclax when administered alone (Part 1) or when administered in combination with ruxolitinib (Part 2). In Part 2, participants must have been receiving a stable dose of ruxolitinib therapy for at least 12 weeks prior to study enrollment. In Part 3, all eligible...

Feb 3rd, 2023 - Owing to the rarity, severity, speed of progression and fatal prognosis of infantile and juvenile GM1, there is a limited understanding of overall disease progression and meaningful outcome measures. This study aims to build a natural history data set through collection of a number of clinical, imaging, and laboratory assessments that may be specific predictors of GM1 disease progression and cl...