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NCT ID: NCT03228082 Completed - Hypertension Clinical Trials

Blood Pressure After PREeclampsia/HELLP by SELF Monitoring Study

BP-PRESELF
Start date: July 13, 2017
Phase: N/A
Study type: Interventional

RATIONALE: Women with a previous history of preeclampsia (PE)/HELLP have a twofold higher risk of cardiovascular disease (CVD) and a fourfold increased risk to develop hypertension at a relative young age. In the latest 2016 ESC guidelines 'CVD prevention', previous PE has been acknowledged as a serious CVD risk factor in women. In clinical practice, however, these women are still underappreciated for their CVD risk. It has not been established yet how adequate lifelong prevention in these potentially high risk women can optimally be achieved from their childbearing years onwards. OBJECTIVE: To evaluate feasibility, usability, acceptance and potential obstacles of blood pressure (BP) home monitoring in high-risk women, aged 40-60 years, after a previous PE in pregnancy. In addition to evaluate the effectiveness of BP home monitoring on the occurrence of hypertension, the efficacy of BP treatment, quality of life (QOL), health-related symptoms, work ability and life-style behaviour. STUDY DESIGN: Randomized, open label feasibility study to compare eHealth guided self management of BP monitoring and lifestyle advice with 'usual care'. STUDY POPULATION: Approximately 200 women, aged ≥ 40 and ≤ 60 years, with a previous PE in pregnancy will be invited to participate (both early and late PE). Patients will be recruited from the departments of obstetrics/gynaecology in 6 centres in the Euregio Rhein-Waal and from the department of cardiology Radboudumc. INTERVENTION: eHealth guided measurements of BP at regular intervals and recurrent lifestyle advice (intervention-group) will be compared with "usual care". PRIMARY OUTCOME: Feasibility, usability, acceptance and potential obstacles of BP home monitoring in high-risk women after a previous PE in pregnancy at 1 year of follow-up.

NCT ID: NCT03227900 Completed - Hunger Clinical Trials

Lidocaine and Food Intake

Start date: July 19, 2017
Phase: Phase 4
Study type: Interventional

World's population over 60 years old is increasing rapidly. It is expected that in 2050 elderly population will be 22% of the total population, representing around 2 billion people. This situation means a rising in the incidence of elderly-related diseases, and thereby the need for long-term care. Reduction in body fat and weight are a common problem among the institutionalized elderly. Some factors that contribute to the anorexia of aging are decreased perception of hunger and increased satiation. This represents an increased risk of developing cachexia even during minor illnesses. The potentially severe consequences of anorexia of aging a greater understanding of the underlying mechanism of these changes is highly important. Intraesophageal and intragastric infusion of 20mg/kg lidocaine results in an increase in food intake in Wistar rats. All infusions were done 30 minutes before the start of the meal intake (meal consisted of mealworms). It may be possible to decrease satiation, increase hunger, and hence food intake in elderly individuals through gastric infusion of the anesthetics lidocaine or benzocaine. In the future this study could potentially contribute to improve food intake in elderly vulnerable of losing body weight. Therefore, the current study aims to investigate the effect of intragastric administration of lidocaine on food intake, satiety/satiation and gastrointestinal complaints.

NCT ID: NCT03227835 Completed - Clinical trials for Contrast-induced Nephropathy

Contrast-Induced Nephropathy After Revision of the Prophylaxis Threshold

CINART
Start date: July 1, 2017
Phase:
Study type: Observational

After administration of intravascular iodinated contrast media Contrast-Induced Nephropathy (CIN), also known as Contrast-Induced Acute Kidney Injury (CIAKI), may occur. CIN/CI-AKI is associated with increased risk of dialysis and mortality. No treatment exists for CIN/CI-AKI, therefore the focus lies on prevention. Clinical practice guidelines for the prevention of CIN/CI-AKI exist and are implemented in most hospitals. Generally, intravascular volume expansion with normal saline is recommended as prophylaxis. Earlier this year the results of the AMACING study (A MAastricht Contrast-Induced Nephropathy Guideline study) were published in The Lancet (NL47173.068.14/METC 14-2-006; Clinical Trials.gov NCT02106234; http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)30057-0/fulltext). These results show that for the greater part (>90%) of patients considered to be at risk of CIN/CI-AKI by the guidelines, withholding prophylaxis is non-inferior to giving standard intravenous prophylactic hydration in the prevention of CIN/CI-AKI. Furthermore, the standard prophylactic hydration confers some risk (5.5% complications of intravenous hydration were recorded in the AMACING study). As a result the clinical protocol in the Maastricht University Medical Centre (MUMC+) has been adapted, and patients with an estimated Glomerular Filtration Rate (eGFR) >29mL/min/1.73m2 no longer receive intravenous prophylactic hydration before or after procedures with intravascular iodinated contrast material administration. CINART is a one year prospective observational study with the aim to evaluate the consequences of the protocol change for 1. for incidences of CIN/CI-AKI, dialysis and mortality, 2. for clinical practice in terms of patient burden (complications of prophylaxis), hospital burden (extra hospitalisations for prophylaxis), and costs, as derived from the number of elective procedures carried out in patients formerly eligible for prophylaxis.

NCT ID: NCT03227471 Completed - Cystic Fibrosis Clinical Trials

A Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis

Start date: January 23, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is a first-in-human and proof-of-concept study of VX-445. The study includes 6 parts. Parts A, B, and C were conducted in healthy subjects. Parts D, E, and F were conducted in subjects with Cystic Fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).

NCT ID: NCT03227146 Active, not recruiting - Burns Clinical Trials

Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents

Start date: October 25, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in adults and adolescents with partial deep dermal and full thickness burns.

NCT ID: NCT03226301 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia in Remission

A Prospective, Multicenter, Phase-II Trial of Ibrutinib Plus Venetoclax in Patients With Creatinine Clearance >= 30 ml/Min Who Have Relapsed or Refractory Chronic Lymphocytic Leukemia (RR-CLL) With or Without TP53 Aberrations

Start date: June 23, 2017
Phase: Phase 2
Study type: Interventional

The aim of the current trial is to evaluate if combination treatment with venetoclax + ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia (RR CLL) can lead to MRD negativity, which may induce long lasting remissions for MRD-negative patients randomized to stopping treatment after 15 induction cycles.

NCT ID: NCT03225612 Recruiting - Heart Valve Disease Clinical Trials

Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)

SCOUT-II
Start date: May 22, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the safety and performance of the Trialign System for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR) in patients with a minimum of moderate tricuspid regurgitation. The procedure will be performed with the PTVAS device using a non-surgical percutaneous approach to tricuspid valve repair in patients who have FTR with a minimum of moderate tricuspid regurgitation.

NCT ID: NCT03225261 Completed - Clinical trials for Irritable Bowel Syndrome

The Effect of Citrus Extract on Gastrointestinal Health

Start date: November 20, 2017
Phase: Phase 2
Study type: Interventional

This randomized, parallel, double-blind, placebo-controlled trial aims to determine the effects of daily administration of citrus extract over a period of 8 weeks on gastrointestinal health in patients with irritable bowel syndrome.

NCT ID: NCT03225222 Completed - Prostate Cancer Clinical Trials

MRI in PROstate Cancer Diagnosis With Prior Risk Assessment

MR-PROPER
Start date: November 1, 2017
Phase:
Study type: Observational [Patient Registry]

To evaluate the diagnostic performance and cost-effectiveness of the MRI-driven diagnostic pathway of prostate cancer, with upfront individual multivariate risk stratification.

NCT ID: NCT03224104 Completed - Glioblastoma Clinical Trials

Study of TG02 in Elderly Newly Diagnosed or Adult Relapsed Patients With Anaplastic Astrocytoma or Glioblastoma

STEAM
Start date: June 12, 2018
Phase: Phase 1
Study type: Interventional

This is a three parallel cohort, open-labeled, non-randomized, multicenter study. All three cohorts will enroll independently.