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NCT ID: NCT03559257 Completed - Migraine Clinical Trials

A Study of Galcanezumab (LY2951742) in Adults With Treatment-Resistant Migraine

CONQUER
Start date: July 31, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of galcanezumab in people with treatment-resistant episodic or chronic migraine.

NCT ID: NCT03559205 Completed - Clinical trials for Musculoskeletal Pain

The MSK-Tracker Study

MSK-Tracker
Start date: July 10, 2018
Phase: N/A
Study type: Interventional

This study will co-design and test the feasibility and impact of implementing the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) using an e-PROM (electronic Patient Reported Outcome Measure) delivered via a digital health platform, with innovative embedded components called the MSK-Tracker. The MSK-Tracker uses the MSK-HQ as a foundation to help patients with MSK pain to: - track the extent to which they are affected by their MSK condition across different aspects of their health, - prepare appropriately for their clinical encounters, and - take the right steps to making positive changes to improve their quality of life and manage their condition over the longer-term. The Study Aims to: 1. Test the ability of the MSK-Tracker to act as an empowerment tool and method of facilitating a person-centred care planning approach in routine MSK clinic consultations. 2. Assess the value of the MSK-Tracker in generating aggregated outputs that inform MSK service improvement. Study Design This study will use a before and after single Centre design with the comparator between phases 1 and 3 across a range of outcomes. Phase 2 will focus on iterative testing of the MSK-Tracker. In addition, in Phase 1 and 3 will include qualitative research (site 1 only) using the Experience Based Co-Design (EBCD) methodology to explore the impact of the MSK-Tracker and to inform further improvement and refinement of the tool and its use within the context of an MSK service and clinical practice. The findings from the qualitative research will be triangulated with insights from the aggregated data of patient outcomes to enrich and help make sense of the study findings.

NCT ID: NCT03559192 Completed - Clinical trials for Depressive Disorder, Major

A Study to Explore the Efficacy of JNJ-67953964 in the Treatment of Depression

Start date: July 16, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of JNJ-67953964 compared to placebo when administered as adjunctive treatment in participants with Major Depressive Disorder (MDD) partially responsive to selective serotonin reuptake inhibitor/ serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) treatment in terms of reduction of symptoms of depression, as assessed by the change from baseline on the Montgomery Asberg Depression Rating Scale (MADRS) in non-responders during the placebo lead-in period.

NCT ID: NCT03559062 Completed - Cystic Fibrosis Clinical Trials

A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 Through 11 Years With Cystic Fibrosis

Start date: May 17, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy of tezacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 through 11 years, who are homozygous for the F508del mutation (F/F) or heterozygous for F508del with an eligible residual function mutation (F/RF).

NCT ID: NCT03558152 Completed - Ulcerative Colitis Clinical Trials

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)

Start date: October 26, 2018
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with vedolizumab and with placebo in the treatment of participants with moderate to severe UC. This study will consist of two parts, Part A and Part B. Part A will test the induction of clinical remission and Part B will test the durability of clinical remission.

NCT ID: NCT03558009 Completed - Abdominal Pain Clinical Trials

Epidemiological Analysis for Hereditary Angioedema Disease

EHA
Start date: September 1, 2018
Phase:
Study type: Observational

An international, multicenter, epidemiological, observational study investigating the prevalence of Hereditary Angioedema (HAE) disease among participants with recurrent episodes of abdominal pain of no obvious etiology.

NCT ID: NCT03557736 Completed - Obese Clinical Trials

Home-Based HIT in Obese Individuals

Start date: March 9, 2015
Phase: N/A
Study type: Interventional

This study aims to investigate the efficacy of a novel home-based high-intensity interval training (Home-HIT) intervention in obese individuals, with elevated cardiovascular disease (CVD) risk. It was hypothesised that Home-HIT would 1) have high adherence to the prescribed exercise intensity (compliance), 2) improve markers of CVD risk, and 3) lead to favourable skeletal muscle adaptations.

NCT ID: NCT03557307 Completed - Asthma Clinical Trials

Study to Evaluate Efficacy and Safety of Benralizumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma

PONENTE
Start date: August 1, 2018
Phase: Phase 3
Study type: Interventional

This is a study designed to evaluate efficacy and safety of Benralizumab in reducing the Oral Corticosteroid (OCS) use in adult patients with severe asthma who are receiving OCS with or without additional asthma controller medications.

NCT ID: NCT03557190 Completed - Clinical trials for Cardiovascular Diseases

Endothelial Effects of VEGF Inhibition In Vivo in Man

ENDEAVOUR
Start date: December 1, 2016
Phase:
Study type: Observational

Recent developments in chemotherapy, particularly VEGF-inhibitor (VEGFI) drugs, have markedly improved the prognosis of patients with cancer. However, these drugs frequently cause high blood pressure (hypertension) which can lead to heart attacks, heart failure and stroke and can limit their use for cancer treatment. Endothelin-1 is a hormone that causes blood vessels to tighten and may contribute to high blood pressure associated with VEGFI drugs. Blocking the effects of endothelin-1 may therefore reduce or prevent VEGFI-associated blood pressure changes, although this has never been tested in humans. Our long-term goal is to assess the protective effects of endothelin-1 blocker drugs in patients treated with VEGFI. Before doing so, we must better explore whether VEGFIs cause blood vessel narrowing and if endothelin-1 blockers prevent this. We will assess this in healthy volunteers using a special technique called 'forearm plethysmography'. We will examine the effect of VEGFI on blood flow and also the effect of simultaneous administration of endothelin-1 blockers. These will be given at doses that produce local effects in the arm without affecting the rest of the body. These studies study will show whether endothelin-1 blockers may help treat VEGFI-associated hypertension to enable more patients safely to receive vital cancer treatments.

NCT ID: NCT03557177 Completed - Clinical trials for Cardiovascular Diseases

Clinical Characterisation of the Vascular Effects of Cis-platinum Based Chemotherapy in Patients With Testicular Cancer

VECTOR
Start date: September 1, 2016
Phase:
Study type: Observational

incidence is increasing1,2. Whilst the prognosis is very good with the vast majority of patients cured with orchidectomy alone, those with high risk stage one non seminomatous germ cell cancer (NSCGT) or metastatic disease (NSCGT or seminoma) are treated by surgery followed by chemotherapy. Platinum based chemotherapy is associated with long-term cardiovascular sequelae. Endothelial dysfunction is a key component of early atherogenesis and the later stages of obstructive atherosclerosis, plaque rupture and thrombus formation. Whilst endothelial toxic effects of BEP chemotherapy appear to be central in the pathophysiology of associated complications, abnormalities in endothelial function as assessed by measures of brachial artery flow-mediated dilatation (FMD) have not demonstrated a consistent effect over time. When assessed within ten weeks of platinum-based chemotherapy9, no change in FMD was observed whilst marked decreases are seen immediately following treatment11 and also one year following treatment12. Therefore, the time-course of endothelial vasomotor impairment remains incompletely defined in a single prospective cohort.