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NCT ID: NCT04224480 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

Longitudinal Immune-phenotyping of HCC Following MK-3475

Start date: December 10, 2019
Phase: Phase 1
Study type: Interventional

The study comprises a main study of pembro-treated HCC patients and a sub-study of untreated HCC patients. In the main study, patients will be treated with pembrolizumab as neoadjuvant treatment approximately 4 weeks prior scheduled surgery. Adjuvant treatment with pembrolizumab with commence at approximately 4 weeks post-surgery for up to 12 months. Subjects will be followed up for a further 12 months after end of treatment for recurrence and survival. The sub-study is a tumour sample collection study which will provide pre-treatment immune microenvironment data from up to 15 pairs of HCC/adjuvant liver tissue samples. Translational analyses performed for liver tissue samples in the sub-study will be harmonized with the analyses on liver tissue samples collected in the main study.

NCT ID: NCT04223856 Recruiting - Urothelial Cancer Clinical Trials

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

EV-302
Start date: March 30, 2020
Phase: Phase 3
Study type: Interventional

This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.

NCT ID: NCT04214132 Completed - Communication Clinical Trials

Evaluation of a Virtual Counseling Application for Communication Skills Training in Nursing Education

Start date: August 1, 2017
Phase: N/A
Study type: Interventional

The Alice Lee Centre for Nursing Studies under the National University of Singapore offers a three-years (four years for honors students), full-time Bachelor of Science (Nursing) program that is accredited by the Singapore Nursing Board. The course covers core modules such as, anatomy, physiology and physical assessment, pathophysiology, pharmacology and nursing practice, communication and cultural diversity, and includes clinical practicums at tertiary hospitals that range from two weeks to three months. This project will be carried out with nursing undergraduates of National University of Singapore who had completed the core module NUR1110 (Effective Communication for Health Professionals) in their year 1 of nursing courses. The 2-year study will follow these students in year 2 and year 3 consecutively by introducing Virtual Patients (VP) depicting real-life case scenarios at gradual difficulty levels before their end-of-semester clinical posting. Four VP case scenarios were developed for each semester on the following topics: 1) interview a pregnant woman with pain to solicit holistic history taking (year 2 semester 1); 2) history taking from a depressed patient (year 2 semester 2); 3) use of a standardized approach such as Situation, Background, Assessment, and Recommendation (SBAR) to hand off interdisciplinary communications (year 3 semester 1); and 4) showing empathy to the fellow nursing student (year 3 semester 2). Overall, the aim of this project is to develop and evaluate the use of VPs in better preparing nursing undergraduates in communicating with real-life patients, family members, and other healthcare professionals during their clinical posting. The specific research questions the investigators plan to answer in this project are as follows: 1. What is the effect of using VPs in enhancing nursing undergraduates' self-efficacy and attitude toward learning communication skills? 2. Do the students receiving additional training using VPs perform better in their communication skills during the clinical posting compared with students receiving standard training? 3. What are the levels of outcomes of students' self-efficacy and attitude toward learning communication skills at pretest (semester 1, year 2 before receiving the VP training), posttest 1 (last day of clinical posting year 2 semester 1), posttest 2 (last day of clinical posting year 2 semester 2), posttest 3 (last day of clinical posting year 3 semester 1), and posttest 4 (last day of clinical posting year 3 semester 2)? 4. What are the changes in self-efficacy and attitude toward communication skills scores over time (pretest, posttests 1-4)? 5. What are the students' experiences in receiving additional training using VPs before their clinical posting? The aim of this paper is therefore to provide a detailed breakdown on the development process of the Virtual Counseling Application using Artificial Intelligence (VCAAI) for communication skills training in nursing education and to highlight challenges faced and recommended resolutions to inform future research.

NCT ID: NCT04210856 Completed - Depression Clinical Trials

Effects of Landscapes on the Brain

Start date: February 28, 2019
Phase: N/A
Study type: Interventional

There is an established consensus between researchers that the contact with natural environments has beneficial influence on mental health and well-being of people exposed to them. The knowledge in this area is based mostly on the correlational analyses, but more research is needed to explore the causal relationships between the human and his environment. More specifically, in order to identify specific restorative mechanisms in response to the specific types and components of the designed landscapes, especially in the highly urbanized context. This study will attempt to find the psychophysiological responses in human brain to landscapes videos (in the lab), and real landscapes with different visual quality, carefully pre-selected and analysed in terms of landscape composition. In the study the rigorous experimental protocol will be administered in order to acquire qualitative and quantitative data both self-reported and measured by neuroscience tools, in order to demonstrate the causal effect of landscape exposure on the brain activity patterns and mood of healthy and depressed individuals.

NCT ID: NCT04210843 Terminated - Clinical trials for Chronic Spontaneous Urticaria

Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab

Start date: April 8, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this extension study was to establish efficacy and safety of ligelizumab. This was assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who had completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment. This study also fulfilled the Novartis commitment to provide post-trial access to patients who had completed studies: CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356), CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878).

NCT ID: NCT04205630 Completed - Endometrial Cancer Clinical Trials

SYD985 in Patients With HER2-expressing Recurrent, Advanced or Metastatic Endometrial Carcinoma

Start date: May 28, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of SYD985 in recurrent, advanced or metastatic endometrial cancer.

NCT ID: NCT04204759 Active, not recruiting - Aggression Clinical Trials

Transcranial Direct Current Stimulation and Antisocial Behavior

Start date: November 3, 2019
Phase: N/A
Study type: Interventional

The main objective of this study is to investigate the causal relationship between prefrontal cortex activity and antisocial behavior, as well as risk factors for antisocial behavior. Specifically, this study tests the hypothesis that upregulating activity in the prefrontal cortex through a non-invasive form of brain stimulation, transcranial direct current stimulation (tDCS) will reduce antisocial and aggressive behavior. The effects of 3 days of anodal stimulation over the prefrontal cortex are assessed.

NCT ID: NCT04202861 Recruiting - Antibiotic Therapy Clinical Trials

Evaluating a Novel Individualised Treatment Strategy for Carbapenem-Resistant Gram-Negative Bacteria Infections

Start date: July 8, 2019
Phase: N/A
Study type: Interventional

Carbapenem-resistant (CR) Gram negative bacteria (GNB) - which are resistant to carbapenems (a last-line potent antibiotic with a high therapeutic index) - are also resistant to all other beta-lactam antibiotics. Most CRGNB are also extensively-drug resistant (XDR) (resistant to all classes of antibiotics except polymyxins and/or tigecycline) or pan-drug resistant (PDR) (resistant to all antibiotics), resulting in a dearth of effective options against these life-threatening infections. Against CRGNB, standard therapy includes monotherapy (using polymyxins or tigecycline) or unguided antibiotics combination (polymyxins + carbapenem). Unfortunately, CRGNB can develop resistance after antibiotic monotherapy, resulting in the further development of pan-drug resistance. Unguided antibiotic combinations, selected anecdotally based on past experience, are also unlikely to be useful in our local setting, as effective antimicrobial combinations are bacterial-strain specific due to large variation in molecular mechanisms of resistance.Hence, the investigators propose to evaluate the efficacy of a novel treatment strategy using in vitro antibiotic combination testing (iACT) to guide antibiotic combinations in the management of patients with CRGNB infections in a randomised controlled trial (RCT).

NCT ID: NCT04200898 Recruiting - Myopia Clinical Trials

Clinical Investigation of the CHEETAH SYSTEM FOR THE CORRECTION OF MYOPIA WITH AND WITHOUT ASTIGMATISM

Start date: December 31, 2019
Phase: N/A
Study type: Interventional

This study will be a 3-phase, 12-months, prospective,single arm, multicenter, open-label, non-comparative, clinical investigation conducted at up to 7 sites. Up to 20 subjects will be enrolled in phase I, up to 30 subjects in phase II, and up to 200 subjects in phase 3 to achieve up to 350 treated eyes.

NCT ID: NCT04200612 Completed - Stress Clinical Trials

The Therapeutic Effects of Equine-Assisted Psychotherapy

EAP
Start date: January 20, 2020
Phase: N/A
Study type: Interventional

Equine-assisted interventions (EAI) are an emerging form of alternate psychotherapy that has been increasingly found to produce improvements in various treatment outcomes. However, the paucity of randomized-controlled trials (RCTs) in the EAI literature prevents any definitive conclusions to be made about the general effectiveness of EAI. This study tests whether one form of EAI, Equine-Assisted Psychotherapy (EAP), reduces aggression and alters risk factors associated with aggression in young adults, and whether emotion regulation mediates any effect of EAP on aggression. In a single-blind RCT, undergraduate students will be randomly assigned to either an intervention group, an active-control group, or a placebo-control group. Participants in the intervention group will undergo a 5-week EAP program consisting of structured, interactive activities with horses followed by a clinical processing component. Participants in the active control group will undergo a 5-week program that only involves interactions with horses without any clinical input (i.e. commonly coined as animal-assisted activities). Participants in the placebo-control group will undergo 5 weeks of 1-hour movie sessions related to horses. There will be three waves of data collection measuring key outcome variables - t1 before the 1st session, t2 after the 3rd session, and t3 after the final session. Participants will complete questionnaires assessing the key outcomes of aggression, emotional well-being and academic performance. Other risk factors of antisocial behaviour such as psychopathy, level of empathy, emotion regulation and executive functioning will also be measured. To the author's knowledge, the current study is the first in Singapore to investigate if EAP can lower aggression levels and alter psychological risk factors for aggression in healthy young adults. In turn, these results could help inform the utility and validity of EAP in the forensic populations.