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NCT ID: NCT04911803 Completed - Anxiety and Worry Clinical Trials

Self-help App and Wellbeing

Start date: June 8, 2021
Phase: N/A
Study type: Interventional

Anxiety and worry are amongst the most common mental health difficulties. The Second Mental Health Study found a significant increase in the lifetime prevalence for GAD, from 0.9% to 1.6%. In addition, the Organisation for Economic Cooperation and Development found that among Singaporean students, 86% experienced anxiety levels that were significantly higher than the OECD average. Past research revealed that individuals who worried more experienced decreases in life satisfaction. It was also found that worry and anxiety are significant predictors of one's psychological wellbeing . In line with this trend, the market for wellbeing apps have been one of the fastest growing categories of apps ever since; with more than 10,000 on the market. Studies have shown that the use of wellbeing apps has been correlated with an improvement in mental wellbeing. However, due to the lack of research that focuses on disorder-specific evidence, there still exists debates around the effectiveness of wellbeing apps on anxiety and worry. In addition, the lack of research on the mediating factor of psychological mindedness in the relationship between the use of wellbeing apps and mental well-being, could be pivotal to the effectiveness of wellbeing apps. To show the effectiveness of evidence-based wellbeing apps in targeting anxiety and worry, this study will employ the engagement of participants with a wellbeing app for a controlled period of 2 weeks before recording their mental wellbeing outcomes.This paradigm has been replicated extensively through multiple studies. This study will use a between-groups experimental study design whereby participants will be block randomised into 2 conditions: Active control condition, and Anxiety condition. Each condition will be given a restricted version of the wellbeing app according to their treatment groups. Follow-up data will be collected at 2-weeks post intervention to establish efficacy of the intervention. Objective 1: To evaluate the effectiveness of a wellbeing app self-help programme for reducing anxiety and worry. Objective 2: To examine if psychological mindedness moderates hypothesised effects of wellbeing app usage and anxiety and worry. Hypothesis 1: Participants in the intervention group will report significantly lower anxiety and worry than participants in the control group. Hypothesis 2: Psychological mindedness will moderate the effect of the wellbeing app's self-help programme on anxiety and worry: Participants high in psychological mindedness will benefit more from the wellbeing apps than those with lower scores on psychological mindedness.

NCT ID: NCT04909515 Withdrawn - Neuroblastoma Clinical Trials

Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission.

Start date: December 2, 2021
Phase: Phase 2
Study type: Interventional

This is a single-arm, uncontrolled, international, multi-center, clinical,phase 2 trial, in patients ≥ 12 months of age with high-risk neuroblastoma in first remission. 120 patients will be enrolled to receive naxitamab + GM-CSF in combination with isotretinoin.

NCT ID: NCT04909073 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

Observational Study of Afatinib 30 mg Daily

Start date: October 25, 2022
Phase:
Study type: Observational

Afatinib, a first-in-class irreversible ErbB family blocker, is a 1st line treatment option for patients with advanced stage NSCLC harbouring sensitizing EGFR mutations. In randomized 1st line studies of afatinib at a standard dose of 40 mg daily versus standard of care, 28-53% of patients required a dose reduction due to adverse events (AE) induced by afatinib. The most common AEs are cutaneous and gastrointestinal (diarrhoea, dysphagia, and mucositis). Prevalence of diarrhoea in patients receiving 40 mg of afatinib, in 1st line phase II and III studies is as high as 90.0% (all grades of diarrhoea) and 14.4% (grade 3-4 diarrhoea). Another important gastrointestinal AE is mucositis, which presents in 51.9%-64.4% of patients treated with afatinib, with only 4.4%-8.3% of the cases being grade 3-4. Dose reduction tended to occur in patients who had higher initial afatinib plasma concentrations and led to decreases in the incidence and severity of afatinib-related AEs without affecting therapeutic efficacy. The incidence of gastrointestinal AEs could be decreased >50% with proper afatinib dose reduction. The effect of 1st line afatinib 30 mg daily in patients with EGFR mutation-positive NSCLC is unknown. We hypothesize that, in patients with EGFR mutation-positive NSCLC, 1st line afatinib treatment at 30 mg daily is tolerable with less gastrointestinal AEs and with a similar efficacy to standard dose afatinib.

NCT ID: NCT04908956 Active, not recruiting - NSCLC Stage IV Clinical Trials

Osimertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR Mutant NSCLC (STEREO)

STEREO
Start date: August 4, 2022
Phase: Phase 2
Study type: Interventional

STEREO is single-arm phase II study, which aims to evaluate the safety and efficacy of osimertinib combined with early locally ablative radiotherapy of all cancer sites in patients with synchronous oligo-metastatic (primary tumour and maximum 5 metastases) EGFR-mutant (exon 19 deletion or exon 21 L858R) NSCLC. Eradication of all macroscopic cancer sites at the time of primary diagnosis by combined modality treatment is expected to decrease the risk of resistance development with only microscopic disease potentially remaining. This will result in an improvement of PFS and OS without added high-grade toxicity.

NCT ID: NCT04906980 Terminated - Dengue Clinical Trials

A Study of JNJ-64281802 in Participants With Confirmed Dengue Fever

Start date: January 24, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the antiviral activity of JNJ-64281802 versus placebo in terms of reduction of dengue virus (DENV) ribonucleic acid (RNA) in primary DENV infection.

NCT ID: NCT04905680 Recruiting - Pre-diabetes Clinical Trials

GluCoach - Technology-enabled Lifestyle Intervention Study

Start date: May 4, 2021
Phase: N/A
Study type: Interventional

This study seeks to address two questions. Firstly, how might a suite of interventions and data feedback (activity, diet, mood*, continuous blood glucose) through coaching be effective in influencing behaviour change for individuals at-risk of developing type 2 diabetes? Secondly, what elements of coaching might be extracted for automated implementation in a scalable coach-light model?

NCT ID: NCT04903197 Recruiting - Clinical trials for Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma

Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma

Start date: January 24, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary efficacy of VAY736 alone or in combination with other therapies in patients with NHL in a platform trial.

NCT ID: NCT04901806 Terminated - Solid Tumor, Adult Clinical Trials

Study of PBI-200 in Subjects With NTRK-Fusion-Positive Solid Tumors

Start date: July 20, 2021
Phase: Phase 1
Study type: Interventional

This is a first-in-human, open-label, multicenter, dose-escalation, safety, PK, and biomarker study of PBI-200 in subjects with NTRK-fusion-positive advanced or metastatic solid tumors.

NCT ID: NCT04897867 Completed - Clinical trials for Non-invasive Fat Reduction

CoolSculpting® Elite for Non-Invasive Fat Reduction

Start date: May 18, 2021
Phase: Phase 4
Study type: Interventional

This study aims to generate data that conveys participant's experiences such as their satisfaction with treatment delivered by the redesigned CoolSculpting® Elite system for non-invasive fat reduction in the midsection area (abdomen and flanks) in addition to optional body areas of upper arms, inner thighs, outer thighs and/or submental area. By doing this, the study will provide insights for doctors to better inform participants about the expected outcomes when one or more body areas are considered for treatment.

NCT ID: NCT04895748 Active, not recruiting - Clinical trials for Carcinoma, Renal Cell

DFF332 as a Single Agent and in Combination With Everolimus & Immuno-Oncology Agents in Advanced/Relapsed Renal Cancer & Other Malignancies

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

This is first in human study of DFF332, a small molecule that targets a protein called HIF2α. By acting on HIF2α, DFF332 may be able to stop the growth of certain types of cancer. DFF332 will be tested at different doses as single agent and in combination with Everolimus (RAD001, an mTOR inhibitor), and also in combination with Spartalizumab (PDR001, an anti-PD1) plus Taminadenant (NIR178, an adenosine A2A receptor antagonist), in patients with advanced clear cell renal cell carcinoma and other malignancies with HIF stabilizing mutations.