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NCT ID: NCT03996369 Completed - Ulcerative Colitis Clinical Trials

Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis

ELEVATE UC 12
Start date: September 15, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of etrasimod on clinical remission in participants with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT03994835 Completed - HIV Infections Clinical Trials

2000 HIV Human Functional Genomics Partnership Program

2000HIV
Start date: October 16, 2019
Phase:
Study type: Observational [Patient Registry]

Background Chronic HIV infection leads to a dysregulated immune system, even when full viral suppression is achieved. HIV causes persistent immune activation, relating to an array of common non-AIDS-related diseases such as cardiovascular disease (CVD) and non-alcoholic fatty liver disease (NAFLD). On the other hand, accelerated ageing of the immune system hinders effective immunity against infectious diseases and cancer. Likewise, this derailed inflammatory balance creates a niche for persistent viral replication and reservoir, and prevents cure or functional cure. Mechanisms behind this phenomenon are poorly understood. Inclusion of a larger cohort of HIV-infected patients allows for a more precise assessment of the factors underlying the immune dysregulation. Primary Objectives - Identify a set of candidate biomarkers that correlate with particular non-AIDS-related comorbidities - Unravel biological processes associated with extreme HIV clinical phenotypes. - Find therapeutic targets to identify novel assets or for repurposing of clinical phase assets from other disease areas for HIV. Secondary Objectives - Evaluate potential relationship of host/immune profiles on efficacy, safety, and tolerability of standard care regimens. - Evaluate the contribution of age, sex, and genetics in host-immune profiles that are: - distinct to HIV infection relative to controls in other cohorts; - associated with non-AIDS-related comorbidities in HIV infection relative to non-HIV chronic disease. Study design 2000 HIV patients will be included in the cohort. The investigators estimate a 2-year inclusion and 2-year follow-up period and will strive for the inclusion of several clinical phenotypes and classical risk group patients. Patients will be recruited from four Dutch HIV treatment centers. At inclusion 1. Collection of metadata using questionnaires and patient medical records 2. Asses co-pathology (CVD and NAFLD) 3. Blood will be drawn for genetic, epigenetic, proteomic, metabolomic, microbiome, immunological, and virological analyses After 2 years follow-up 1. Collection of metadata using questionnaires and patient medical records 2. Asses co-pathology (CVD and NAFLD) 3. Blood samples will be collected for biomarker and infection/inflammation parameter analysis

NCT ID: NCT03992248 Completed - Clinical trials for Type 2 Diabetes Mellitus

Effect of Eating Within a Limited Time on Sugar Sensitivity and Liver Sugar Stores of People With Type 2 Diabetes.

TRF
Start date: January 31, 2019
Phase: N/A
Study type: Interventional

Modern life is characterized by a 24-hour lifestyle in which food intake is no longer restricted to daytime. As a result, people nowadays tend to eat throughout the day. When food is being consumed the energy is both used and stored for later use. Eating for a prolonged period of time makes it unnecessary for the body to use its energy storage. It is hypothesized that the decreased use of energy stores has detrimental effects on our sugar balance, mainly on insulin sensitivity. Conversely, eating within a limited period during the day could improve insulin sensitivity in people with type 2 diabetes by an increased use of energy reserves, specifically liver sugar stores. Therefore, this study examines the effect of eating within a limited time frame during the day on insulin sensitivity and liver sugar stores of people with type 2 diabetes.

NCT ID: NCT03989011 Completed - Clinical trials for Abdominal Aortic Aneurysm

Tonometry and Duplex Ultrasound to Predict AAA Progression and CV Events in Aneurysm Patients (1-2-3 Trial)

Start date: July 1, 2019
Phase:
Study type: Observational

Abdominal aortic aneurysm (AAA) is a common vascular disease and associated with risk of rupture, but also with a high cardiovascular (CV) event rate. A key difficulty in AAA is predicting these life-threatening complications, highlighting the need to explore the potential of novel techniques. Both progression of AAA and CV events are strongly linked to vascular health. In 2013, the SMART risk score is developed to calculate the risk of the patients for recurrent vascular events based on clinical characteristics. Recently, a novel, easy to perform, non-invasive test of endothelial function (the carotid artery reactivity (CAR) test), reflecting target organ damage, has recently been introduced. The CAR is a simple, quick (5-min), non-invasive test that uses ultrasound to examine the carotid artery in response to sympathetic stimulation by placing one hand in cold water. This test shows strong agreement with both coronary and aortic responses to sympathetic stimulation and predicted CV events in patients with peripheral arterial disease. The aim of this prospective 2-year follow-up study is to investigate the predictive capacity of the CAR-test in comparison to the SMART risk score for the development of cardiovascular events in patients with an abdominal aortic aneurysm who have not yet reached the treatment threshold. This could aid clinical decision making in the need for (surgical) intervention, but also alter (drug) treatment to reduce risk of cardiovascular events. Secondary objectives are to investigate the predictive capacity of the CAR-test for progression of the abdominal aortic aneurysm, and to evaluate QoL scores in patients under surveillance for AAA. The aim is to provide insight if these scores can help clinical decision making.

NCT ID: NCT03985943 Completed - Clinical trials for Moderate-to-Severe Atopic Dermatitis

Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

Start date: June 30, 2019
Phase: Phase 3
Study type: Interventional

The main purpose of the study is to assess the efficacy and safety of nemolizumab after a 16-week treatment period in adult and adolescent subjects with moderate-to-severe atopic dermatitis (AD) not adequately controlled with topical treatments.

NCT ID: NCT03979248 Completed - Healthy Clinical Trials

A Study to Investigate the Effects of Gastric Acid Suppression by Rabeprazole and BMS-986165 on How Fast and Complete The Drug is Absorbed Into the Body of Healthy Participants

Start date: May 16, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the effects of stomach acid suppression by rabeprazole and BMS-986165 on how fast and complete the drug is absorbed into the body of healthy participants.

NCT ID: NCT03978520 Completed - Clinical trials for Systemic Lupus Erythematosus (SLE)

A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)

SLEek
Start date: July 25, 2019
Phase: Phase 2
Study type: Interventional

The main objective of this study was to evaluate the safety and efficacy of elsubrutinib, upadacitinib (UPA), and ABBV-599 (elsubrutinib/upadacitinib) High Dose and Low Dose combinations vs placebo for the treatment of signs and symptoms of Systemic Lupus Erythematosus (SLE) in participants with moderately to severely active SLE and to define doses for further development.

NCT ID: NCT03976271 Completed - Clinical trials for Diabetes Mellitus, Type 2

Consequences of Hypoglycaemia on Cardiovascular and Inflammatory Responses

HCIR
Start date: August 12, 2019
Phase: N/A
Study type: Interventional

People with Type 1 diabetes (T1DM), type 2 diabetes (T2DM) and healthy volunteers will undergo a hypoglycaemic clamp to to investigate the effect of hypoglycaemia on cardiovascular and inflammatory responses.

NCT ID: NCT03970356 Completed - Clinical trials for Urinary Tract Infections

Improving Antibiotic Prescribing for Urinary Tract Infections in Frail Elderly

ImpresU-WP2
Start date: September 1, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a tailored multifaceted antibiotic stewardship intervention reduces antibiotic use for urinary tract infections in residential care homes and nursing homes attended by general practitioners. This will be evaluated in a pragmatic cluster randomised controlled trial using a modified community-based participatory action research approach.

NCT ID: NCT03969888 Completed - Cystic Fibrosis Clinical Trials

A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222

Start date: December 11, 2019
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety, tolerability, and efficacy of ABBV-3067 given alone and in combination with various doses of ABBV-2222 in adults with Cystic Fibrosis who are homozygous for the F508del mutation.