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NCT ID: NCT05037097 Recruiting - COVID-19 Clinical Trials

A Trial Evaluating the Safety and Immunogenicity of 3 COVID-19 SARS-CoV-2 RNA Vaccines in Healthy Adults

Start date: August 30, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, randomized, observer-blind study in healthy adults. The study will evaluate the safety, reactogenicity, and immunogenicity of 3 SARS-CoV-2 self-amplifying RNA vaccine candidates against COVID-19 in adults previously vaccinated and not previously vaccinated against SARS-CoV-2.

NCT ID: NCT05036902 Completed - Clinical trials for Head and Neck Cancer

The Impact of Multimodality Treatment on Physical Functions and Quality of Life in Patients With Head and Neck Cancer

Start date: January 23, 2017
Phase:
Study type: Observational

Oral cancer (including the lip) alone, with 300.373 cases worldwide in 2012, is the predominant head and neck squamous cell carcinoma. With an incidence of 6.5 cases per 100.000, south - east asia has the highest incidence worldwide. Many of these cases do present at a locally advanced stage, which often requires combined modality treatment that includes extensive surgery to the primary site and neck and flap reconstruction. This is often followed by either adjuvant radiation or chemo-radiotherapy. This treatment can come with a significant morbidity affecting the self-care ability of the patients as well as impact the quality of life(QOL) (3,4).At the SingHealth Duke - NUS Head and Neck Centre 340 complex cases of head and neck cancer (HNC) involving flap reconstructions and extensive resections have been operated in 2014 alone. Almost all of these patients need further adjuvant treatment (radiotherapy and/or chemotherapy). Side-effects following such treatments, Significant number of patients underwent subsequent adjuvant treatment. The adjuvant treatment and surgery may render these patients weakness of the shoulder and neck muscles, numbness and reduced sensation around the neck and shoulder region and a general impact on the patient's fitness. While survival remains the most important outcome in oncologic treatment, recovery of treatment related morbidity and return to pre-treatment QOL for patients after cancer treatment is equally important. The aims of this study is to evaluate the impact of surgical and adjuvant treatment on physical functions and QOL of the patients. By measuring the impact of extensive treatments for head and neck malignancies on the fitness and QOL of these patients, the team aims to identify the risk factors that necessitate a more aggressive rehabilitation. This is to date the first prospective study investigating the impact of multimodality treatment on fitness and QOL in HNC patients in a structured and predefined manner. Ultrasound (US) elastography will be used to assess muscle and soft tissue stiffness and elasticity and correlate these with functional outcome measurements. Elastography has been previously described as a useful tool to assess stiffness of the neck soft tissues and muscles, however no study thus far has correlated these findings with functional measurements. Hence this trial aims to establish the following: 1. Due to the limited available data: to quantify and qualify the impact of surgery as well as adjuvant treatment on the fitness, physical function of the neck and shoulder & QOL of HNC patients 2. To establish a workflow and assessment protocol for a subsequent larger prospective clinical trial 3. To identify performance markers in these patients, that allow a more targeted rehabilitation process 4. Many patients post head and neck treatment are economically compromised since they are unable to return to mainstream work and there exists a significant unemployment rate. The understanding we gain through objective analysis apart from targeted treatment for every individual patient, in the future this study hopes to address and improve the economic impact to the individual and probably reduce the health care burden.

NCT ID: NCT05036135 Active, not recruiting - Clinical trials for Pulmonary Arterial Hypertension

A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)

IMPAHCT
Start date: December 2, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

IMPAHCT: Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial is a Phase 2b/Phase 3 study to evaluate the safety and efficacy of AV-101 (dry powder inhaled imatinib) in patients with Pulmonary Arterial Hypertension (PAH). The Phase 2b part of the study will assess three doses to establish an optimal dose for the Phase 3 part of the study. The Phase 2b primary endpoint will be the placebo corrected change in pulmonary vascular resistance (PVR). The Phase 3 primary endpoint will be the placebo corrected change in 6-minute walk distance (6MWD) after 24 weeks of treatment.

NCT ID: NCT05035745 Recruiting - Clinical trials for Advanced Refractory Solid Tumors

Selinexor & Talazoparib in Advanced Refractory Solid Tumors; Advanced/Metastatic Triple Negative Breast Cancer (START)

Start date: March 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a single arm, open-label, phase I dose finding study, followed by a phase II expansion study. Phase I will be carried out in a modified 3+3 dose escalation design, with a projected enrolment of 33 patients with refractory solid tumors to determine the RP2D. In the phase II portion, a total of 30 patients with advanced/metastatic TNBC will be enrolled.

NCT ID: NCT05034185 Completed - Colonic Neoplasms Clinical Trials

Real-World Validation of an Artificial Intelligence Characterization Support (CADx) System

Start date: March 3, 2021
Phase:
Study type: Observational

Colorectal cancer (CRC) is a leading cause of cancer-related morbidity and mortality worldwide, with rates of CRC predicted to increase. Colonoscopy is currently the gold standard of screening for CRC. Artificial intelligence (AI) is seen as a solution to bridge this gap in adenoma detection, which is a quality indicator in colonoscopy. AI systems utilize deep neural networks to enable computer-aided detection (CADe) and computer-aided classification (CADx). CADe is concerned with the detection of polyps during colonoscopy, which in turn is postulated to help decrease the adenoma miss-rate. In contrast, CADx deals with the interpretation of polyp appearance during colonoscopy to determine the predicted histology. Prediction of polyp histology is crucial in helping Clinicians decide on a "resect and discard" or "diagnose and leave strategy". It is also useful for the Clinician to be aware of the predicted histology of a colorectal polyp in determining the appropriate method of resection in terms of safety and efficacy. While CADe has been studied extensively in randomized controlled trials, there is a lack of prospective data validating the use of CADx in a clinical setting to predict polyp histology. The investigators plan to conduct a prospective, multi-centre clinical trial to validate the accuracy of CADx support for prediction of polyp histology in real-time colonoscopy.

NCT ID: NCT05030428 Active, not recruiting - Clinical trials for Atherosclerotic Cardiovascular Disease

Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease

VICTORION-2P
Start date: November 23, 2021
Phase: Phase 3
Study type: Interventional

Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).

NCT ID: NCT05030311 Completed - Clinical trials for Chronic Spontaneous Urticaria

A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines

REMIX-1
Start date: November 30, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) in adult participants suffering from chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines in comparison to placebo.

NCT ID: NCT05026619 Active, not recruiting - Anxiety Clinical Trials

Youth Outlook on Life Opportunities Study

Start date: September 21, 2021
Phase: N/A
Study type: Interventional

Singapore's fertility rate is currently below 1.2, raising concerns about population ageing and long-term sustainability. The fertility decline is characterized by falling birth rates among women in their 20s with almost no recuperation among women in their 30s. This project explores a) whether informational imperfections help to account for high intended ages at childbearing in Singapore, b) whether informational interventions significantly affect ideal and expected ages at marriage and childbearing, and expected probability of undergoing social egg freezing, and c) whether informational interventions significantly affect expected and actual educational outcomes and labor market outcomes. Our hypotheses are: 1. University students have knowledge gaps about age-related onset of infertility, assisted reproductive technologies and local policy initiatives related to age at marriage and childbearing, especially among male students. 2. Being exposed to accurate information in these domains leads to significantly lower ideal/expected ages at marriage and childbearing, and higher expected probability of undergoing social egg freezing, immediately after the intervention. 3. Being exposed to accurate information in these domains does not lead to lower educational and labor market expectations immediately after the intervention among either male or female students, or to significant differences in module choices, Cumulative Average Point (CAP), starting salary and employment status of university students in the following academic semester and six months after graduation, among either male or female students.

NCT ID: NCT05022433 Completed - Clinical trials for Very Low Birth Weight Infant

Comparison of the Shukla and UN-1 Formulae in the Placement of the Umbilical Venous Catheter Among Neonates

Start date: June 6, 2019
Phase:
Study type: Observational

Umbilical vein catheters (UVC) are commonly inserted in newborns especially neonates admitted to the Neonatal Intensive Care Unit (NICU).These catheters are used since 1959. It is a suitable method for parenteral nutrition access and medications administration. Despite the benefits of the UVC, its potential complications must be considered. Thus, it is vital to determine the appropriate penetration length of the UVC.

NCT ID: NCT05018962 Completed - Clinical trials for Dialysis Access Malfunction

Recurrent Stenoses in Arteriovenous Fistula (AVF) for Dialysis Access: CuttIng ballooN angioplaSTy Combined wITh Paclitaxel drUg coaTed Balloon Angioplasty, an observatIONal Clinical Study

INSTITUTION
Start date: September 8, 2017
Phase: Phase 2
Study type: Interventional

To determine if cutting balloon angioplasty combined with DEB angioplasty provides a higher primary patency after treatment of recurrent stenoses compared with cutting balloon angioplasty or angioplasty using DEB alone in the venous outflow AVFs. For cutting balloon angioplasty in venous stenosis, the primary patency after 12 months is 55-60% (9,16) and in recurrent stenoses up to 48%(10). We hypothesise that DEB angioplasty after cutting balloon angioplasty leads to improved primary patency at 12 months.