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NCT ID: NCT03005782 Completed - Malignancies Clinical Trials

Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers

Start date: November 7, 2016
Phase: Phase 1
Study type: Interventional

The primary objectives in the dose escalation phase are to evaluate safety and pharmacokinetics (PK) in order to determine the selected dose level(s) for expansion of REGN3767 as monotherapy and in combination with cemiplimab in patients with advanced malignancies, including lymphoma. The primary objectives in the dose expansion phase are to assess preliminary anti-tumor activity of REGN3767 alone and in combination with cemiplimab (separately by cohort) as measured by objective response rate (ORR).

NCT ID: NCT03005652 Completed - Clinical trials for Cognitive Dysfunction

Effects Of An 8-Weeks Mindfulness-based Intervention In Individuals With Subjective Cognitive Decline

SCD-WELL
Start date: April 21, 2017
Phase: N/A
Study type: Interventional

The European Commission Horizon 2020 programme has funded the SCD-WELL trial to investigate the efficacy of mindfulness-based training to reduce anxiety in individuals with Subjective Cognitive Decline (SCD), in comparison to an active comparison condition. It is increasingly recognized that most neuropathological processes start years before the onset of clinical Alzheimer's disease (AD). Hence, there is a growing urgency to target individuals in the earliest stages for intervention when neurodegeneration is still limited. Individuals clinically judged to have SCD, defined by subjectively experienced cognitive decline but normal performance on cognitive tests, are at increased risk for future cognitive decline and AD. These individuals with SCD currently have no established treatment options. Symptoms of anxiety have high prevalence in this population, and evidence from recent longitudinal research links anxiety with significantly accelerated cognitive decline in at risk individuals. Effectively reducing anxiety in this population may therefore not only relieve participants from burdensome symptoms, but may also slow cognitive decline and delay or prevent the onset of AD. The investigators chose to study the efficacy of a mindfulness-based intervention to reduce anxiety in this population because this type of intervention has been shown to reduce anxiety in a number of populations, including in older adults. Further, accumulating evidence indicates that intensive mindfulness training effectively down-regulates a number of other adverse psychological and biological risk factors for AD, such as stress, depression, insomnia, feelings of loneliness and social exclusion, and cardiovascular risk factors. These findings are relevant to AD because approximately a third of AD cases worldwide might be attributable to potentially modifiable risk factors. In spite of the increased use of mindfulness-based interventions to treat clinical symptoms, these trials often suffer from the lack of an adequate comparison condition and lack of follow up to know whether initial benefits are maintained.

NCT ID: NCT03005288 Completed - Clinical trials for Diabetes Mellitus, Type 2

Safety, Pharmacokinetics and Efficacy of Bimagrumab in Overweight and Obese Patients With Type 2 Diabetes

Start date: February 1, 2017
Phase: Phase 2
Study type: Interventional

This study assessed the safety, pharmacokinetics and efficacy of bimagrumab when administered in overweight and obese patients with type 2 diabetes

NCT ID: NCT03004495 Completed - Copd Clinical Trials

Pharmacokinetic Interaction and the Safety of Inhaled CHF5259 and CHF6001

Start date: January 2016
Phase: Phase 1
Study type: Interventional

To evaluate systemic pharmacokinetics of CHF6001 following concomitant administration of CHF6001 and CHF5259, in comparison with the single components, administered in healthy subjects via a multi-dose reservoir NEXThaler® DPI.

NCT ID: NCT03004417 Completed - COPD Clinical Trials

Pharmacodynamics, Pharmacokinetics and Safety of Two Doses of CHF6001 DPI in Subjects With Moderate, Severe COPD

Start date: October 31, 2016
Phase: Phase 2
Study type: Interventional

Effect of CHF 6001 on biomarkers of inflammation in induced sputum and in blood, on pulmonary function and on symptoms benefits in comparison with placebo.

NCT ID: NCT03004027 Completed - Social Anxiety Clinical Trials

Enhancing Psychological Self-help With Implementation Intentions

Start date: January 2017
Phase: N/A
Study type: Interventional

Individuals with visible conditions often report experiencing lowered social confidence and encountering intrusive reactions from others, yet relatively few targeted psychosocial self help interventions are available. The investigators will conduct a randomised controlled trial to compare the efficacy of an adapted form of an existing self-help intervention with an enhanced version of the same intervention that incorporates if-then planning instructions (or 'implementation intentions') and a control condition that will receive support as usual. Participants who self-identify as having a visible condition affecting the skin or hair, or scarring to the skin that negatively affects their social confidence will be allocated to one of three conditions: augmented self-help, standard self help or control. The interventions will be delivered online and participants will complete psychometric outcome measures at two time points, four weeks apart. It is hypothesised that participants who receive the augmented self help intervention will have a statistically significant decrease in fear of negative evaluation in comparison to both the standard self-help and support as usual control groups.

NCT ID: NCT03003923 Completed - Health Behavior Clinical Trials

Promoting Vegetable Intake in Preschool Aged Children

Start date: September 2016
Phase: N/A
Study type: Interventional

The aim of this cluster randomised control trial is to test the efficacy of a repeated taste exposure intervention, a nutritional educational intervention and combination of both to increase intake of an unfamiliar vegetable in preschool aged children (aged 3-5 years).

NCT ID: NCT03003702 Completed - COPD Exacerbation Clinical Trials

Domiciliary Monitoring to Predict Exacerbations of COPD

Start date: September 2016
Phase: N/A
Study type: Interventional

Chronic Obstructive Pulmonary Disease (COPD) is a common, long term condition of the lungs that is usually caused by cigarette smoking. In addition to daily symptoms and limitation in activities, patients are prone to developing chest infections called 'exacerbations'. Exacerbations are a big problem: unpleasant for patients, and sometimes severe enough to cause hospital admission (and therefore health facilities pressures) and death. Reducing the impact of exacerbations is very important. Investigators have previously shown that earlier treatment of COPD exacerbations results in faster recovery, and reduced chance of hospital admission. Helping patients to detect exacerbations early is therefore important. Investigators have also recently shown that monitoring heart rate and oxygen saturation via a finger probe may assist in this. However, measuring these variables when the patient is awake means they can be affected by other things, such as exercise and anxiety. Our new idea is that measuring heart rate and oxygen level overnight, when a patient is asleep, will give the best chance of detecting COPD exacerbations early and our study will test that. Investigators will randomly allocate 77 patients with COPD recruited from our service in London to standard monitoring, or overnight monitoring, for up to six months or the first exacerbation, whichever is sooner. Investigators will then analyse whether overnight monitoring was able to detect exacerbations earlier, and therefore could be used to help patients get treatment earlier. A subset of participants will also wear an activity monitor overnight for the first two weeks, so that Investigators can assess the effect (if any) of overnight awake periods (such as trips to the bathroom) on the heart rate and saturation recording.

NCT ID: NCT03003520 Completed - Clinical trials for Lymphoma, Large B-Cell, Diffuse

A Study of Durvalumab in Combination With R-CHOP or Lenalidomide Plus R-CHOP in Previously Untreated High-Risk Diffuse Large B-Cell Lymphoma

Start date: February 28, 2017
Phase: Phase 2
Study type: Interventional

This Phase 2, two-arm, open-label study is designed to evaluate the safety, clinical activity, and predictive biomarkers of durvalumab in combination with R-CHOP or R2-CHOP, followed by durvalumab consolidation therapy in previously untreated subjects with high-risk diffuse large B-cell lymphoma (DLBCL). Induction treatment with R-CHOP (± lenalidomide) will last for a total of up to 6 to 8 treatment cycles (21 day cycles), and the total time on study treatment, including durvalumab consolidation, will last up to 12 months. On 05-Sep-2017, the US FDA has issued a Partial Clinical Hold on this study resulting in the discontinuation of enrollment into Arm B (Durvalumab + Lenalidomide + R-CHOP). After the US FDA Partial Clinical Hold, new eligible participants have been enrolled in Arm A (Durvalumab + R-CHOP).

NCT ID: NCT03003442 Completed - Healthy Clinical Trials

Effects of Supradyn® Energy 3RDA on Fatigue/Stress, Substrate Metabolism During Exercise and Demanding Cognitive Tasks

Start date: November 1, 2016
Phase: N/A
Study type: Interventional

Investigation of the acute and chronic effects of Supradyn® Energy 3RDA on subjective ratings of 'fatigue/stress', substrate metabolism and blood biomarkers of recovery, as a consequence of exercise and metabolically demanding cognitive tasks.