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NCT ID: NCT04895384 Recruiting - Atrial Fibrillation Clinical Trials

El DORADO STUDY (Evaluation of Delivery of Oxygen on Renal, Arrhythmia and Delirium Outcomes Study)

Start date: July 27, 2021
Phase:
Study type: Observational

The study aims to develop a novel perioperative noninvasive delivery of oxygen (DO2) and hemodynamic index in the prediction of postoperative outcomes including post-operative acute kidney injury (POAKI), perioperative neurological cognitive disorders (PONCD) and post-operative atrial fibrillation (POAF). Our study also aims to study the effect of DO2 and hemodynamic parameters (measured noninvasively) on the development of PONCD, POAF and POAKI in cardiac surgical patients. We aim to develop a novel DO2 index and hemodynamic index predictive of PONCD, POAF and POAKI. The secondary aim would be to develop real-time machine learning aided algorithms in the analysis of noninvasive continuous hemodynamic and DO2 data, to predict and guide perioperative treatment of POCND, POAF and POAKI in the perioperative setting.

NCT ID: NCT04893551 Terminated - Ovarian Neoplasms Clinical Trials

A Study of Tilvestamab (BGB149) in Relapsed, Platinum-resistant, High-grade Serous Ovarian Cancer (HGSOC) Participants

Start date: February 25, 2021
Phase: Phase 1
Study type: Interventional

The primary purpose is to assess the safety and tolerability of tilvestamab following IV administration of multiple doses to participants with HGSOC who have been treated with at least 1 complete course of platinum-based chemotherapy and whose disease has relapsed with platinum resistance ([PRR]-HGSOC) and to determine the plasma pharmacokinetics (PK) exposure by comprehensive profiling (at single dose and steady-state) of multiple ascending doses of tilvestamab.

NCT ID: NCT04892368 Recruiting - Surgery Clinical Trials

Efficacy of Preoperative Prehabilitation With a Home-based Supervised Exercise Program Against an Unsupervised Exercise Program for Frail Elderly Patients Undergoing Major Abdominal Surgery

HOME-PREPARE
Start date: April 10, 2021
Phase: N/A
Study type: Interventional

Singapore's population is ageing, and more elderly people are undergoing elective major surgeries. Frail elderly experience greater functional decline and slower recovery in physical function after surgery compared to non-frail elderly. Preoperative prehabilitation aims to enhance both aerobic capacity and physical strength of elderly to attenuate the post-operative decline in physical function. Singapore General Hospital has a bespoke preoperative program - Prehabilitation for Elderly Frail Patients Undergoing Elective Surgeries (PREPARE), where patients receive physiotherapy education and instructions for home-based unsupervised exercise program (uSEP). A hospital-based supervised exercise program had also been established but the take-up rate was low (7.6%) due to barriers such as cost and accessibility. Perioperative supervised exercise training can effect greater gains in functional capacity and muscle strength compared to no supervision. For the elderly with limited transport options to the hospital, home-based supervised programmes may be more convenient compared to hospital-based supervised programmes, but the former is costlier too. Home-interventions may also empower patients with the skills and confidence to maintain their physical fitness at home, which increases their likelihood of exercising after surgery. The investigators propose a prospective single-center randomized controlled trial to evaluate the efficacy of preoperative prehabilitation with a home-based supervised exercise program (SEP) for frail elderly patients undergoing major abdominal surgery, compared to the mainstay of clinical practice, which is a home-based uSEP.

NCT ID: NCT04891770 Active, not recruiting - Chronic Hepatitis B Clinical Trials

Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB)

Start date: August 14, 2021
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate the safety and tolerability of study treatment(s) (selgantolimod-containing combination therapies) and to evaluate the efficacy of study treatment(s) as measured by the proportion of participants who achieve functional cure, defined as hepatitis B surface antigen (HBsAg) loss and hepatitis B virus (HBV)deoxyribonucleic acid (DNA) < lower limit of quantitation (LLOQ) at Follow-up (FU) Week 24 in participants with chronic hepatitis B (CHB).

NCT ID: NCT04888299 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Artificial Intelligence System Based on Raman Spectroscopy in Inflammatory Bowel Disease

Start date: April 14, 2021
Phase: N/A
Study type: Interventional

Inflammatory bowel diseases (IBD) are chronic inflammatory disorders that can be categorized as ulcerative colitis (UC), Crohn's disease (CD) and indeterminate colitis (IC). Deep remission has been shown to improve disease outcome. There may be a lack of concordance between endoscopic and histologic remission. IBD patients with long standing colitis are at risk of developing dysplasia and colorectal cancer (CRC). However, it can be challenging to diagnose dysplasia in IBD patients during colonoscopy, as dysplasia frequently manifests as non-pedunculated lesions that present with only subtle visible changes or are even invisible due to the surrounding inflammation, scarring, pseudopolyps, or hyperplasia. Although white light endoscopy and chromoendoscopy are the current standard modality of imaging, there is still a gap to be bridged, in terms of improving endoscopic diagnosis of dysplasia and improving concordance of endoscopic and histologic remission. Raman spectroscopy is an inelastic light scattering technique provide specific fingerprints of molecular compositions and structures of biological tissues. It may be able to provide additional diagnostic information over standard endoscopy. A second-generation Raman endoscope system for improving in vivo tissue characterization and diagnosis during colonoscopy has been developed (SPECTRA IMDx system). Preliminary data suggested its utility in the diagnosis of colorectal neoplasia during colonoscopy. There is currently a lack of data concerning the application of this novel technology in the context of IBD. Specifically, whether the spectral signals generated can be used to better classify disease remission, and thus achieve higher concordance with histology when compared to standard endoscopy. It is also unclear whether this technology can be used to differentiate dysplastic mucosa from non-dysplastic mucosal in IBD patients. Hypotheses 1. Raman spectroscopy based artificial intelligence system has the potential to be used to differentiate disease remission from active mucosal inflammation and hence improve concordance between endoscopic and histologic remission, with the potential to decrease the need for random biopsies real-time during colonoscopy. 2. Raman spectroscopy based artificial intelligence system has the potential to differentiate dysplastic mucosa in IBD patients (low grade and high grade dysplasia; colorectal cancer) from non-dysplastic mucosa. real-time during colonoscopy.

NCT ID: NCT04886804 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene)

Start date: June 22, 2021
Phase: Phase 1
Study type: Interventional

The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful. The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene. The purpose of the first study part is to find the highest dose of a medicine called zongertinib the participants can tolerate. Once this dose is found, it will be used in the second study part to test whether zongertinib can make tumours shrink. In this study, zongertinib is given to people for the first time. Participants take zongertinib as tablets once a day or twice a day. The participants are in the study for as long as they benefit from and can tolerate treatment. Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by zongertinib.

NCT ID: NCT04885998 Active, not recruiting - Clinical trials for Small Cell Lung Cancer

AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)

Start date: September 27, 2021
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to evaluate the safety, tolerability, and recommended phase 2 target dose of tarlatamab in combination with AMG 404.

NCT ID: NCT04880629 Active, not recruiting - Sleep Clinical Trials

Monitoring Sleep and Glucose Among University Students

Start date: March 3, 2021
Phase: N/A
Study type: Interventional

This study aims to characterise associations between day-to-day sleep, activity, meal schedules, well-being and continuous glucose profiles in a cohort of free-living healthy, young adults. Multi-day data will be collected using wearables and smartphone-based measures in field settings.

NCT ID: NCT04879186 Active, not recruiting - Clinical trials for Contrast-induced Nephropathy

Contrast Induced Nephropathy Among Vascular Patients Undergoing Lower Limb Angioplasty

Start date: July 1, 2015
Phase:
Study type: Observational

Contrast induced nephropathy (CIN) is an iatrogenic renal injury following intravascular administration of radio-opaque contrast media (CM) in susceptible individuals. As the third leading cause of hospital acquired renal failure, it is associated with increased mortality, morbidity and prolonged hospital stay. Endovascular procedures have gained greater popularity in the past decade due to the advance in technology. This has also led to the increased incidence of CIN after vascular surgeries. We are conducting a retrospective cohort study in Singapore General Hospital using our perioperative database collected in the past five years. We will be extracting relevant patient perioperative information including both clinical diagnosis and lab values. Our primary aim is to establish the incidence of CIN among vascular patients with or without pre-existing chronic renal impairment undergoing elective peripheral endovascular angioplasty. Our secondary aims are to establish the risk factors and protective factors that lead to the development of CIN in vascular patients after peripheral endovascular angioplasty. We will also be looking at the long-term outcome of patients who have developed CIN after vascular endovascular angioplasty. The results of the study will enable us to identify patients at high risk of development of CIN, thus appropriate measures can be initiated early and help with their recovery process.

NCT ID: NCT04878380 Completed - Sleep Clinical Trials

hiSG Sleep Health Study

hiSG-SHS
Start date: August 15, 2021
Phase: N/A
Study type: Interventional

The hiSG Sleep Health Study seeks to investigate the efficacy of education + goal-based programmes for the promotion of healthy sleep habits and to evaluate its impact on daytime sleepiness and mental health.