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NCT ID: NCT04724837 Completed - Clinical trials for Chronic Kidney Disease

Zibotentan and Dapagliflozin for the Treatment of CKD (ZENITH-CKD Trial)

ZENITH-CKD
Start date: April 28, 2021
Phase: Phase 2
Study type: Interventional

The purpose of the study is to assess efficacy, safety and tolerability of treatment with zibotentan and dapagliflozin in combination and dapagliflozin 10 mg as monotherapy in participants with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73 m^2, and urinary albumin to creatinine ratio (UACR) ≥ 150 mg/g and ≤ 5000 mg/g.

NCT ID: NCT04723979 Completed - Clinical trials for Post Partum Hemorrhage

NovoSeven® in Severe Postpartum Haemorrhage - Experiences From UK, DK, FR, NL

Start date: May 1, 2020
Phase:
Study type: Observational

The overall aim of this project is to include currently available information from women with severe postpartum haemorrhage (sPPH) who were treated with NovoSeven® and to examine whether NovoSeven® may have affected the course of the PPH in these women, specifically the control of bleeding. Data will be included from previous cohort studies from four countries: United Kingdom (UK), the Netherlands, Denmark, and France.

NCT ID: NCT04722991 Completed - Clinical trials for Diabetic Retinopathy

Non-proliferative Diabetic Retinopathy Treated With Runcaciguat

NEON-NPDR
Start date: March 17, 2021
Phase: Phase 2
Study type: Interventional

This Phase 2 study is conducted to investigate the safety and efficacy of runcaciguat in the treatment of diabetic retinopathy. To assess efficacy, the retinal morphology will be investigated by 7-field color fundus photography for central assessment of the diabetic retinopathy severity score, or DRSS. Two-step DRSS improvement at 24 weeks of treatment will be the primary efficacy endpoint. DRSS assessments are repeated after completion of 48 weeks of treatment. In addition, vision threatening complications will be recorded throughout the study and assessed as secondary efficacy endpoint.

NCT ID: NCT04722068 Completed - Clinical trials for Hypercholesterolemia, Familial

Regeneron 1331 Kinetics Sub-Study HoFH

Start date: October 7, 2016
Phase: N/A
Study type: Interventional

To evaluate the lipoprotein kinetics of subjects enrolled in the R1500-CL-1331 clinical trial (NCT02265952) to assess the mechanism by which the evinacumab may affect lipid levels in HoFH subjects.

NCT ID: NCT04721002 Completed - Clinical trials for Multiple Myeloma (MM)

Study to Evaluate t(11;14) Status and BCL2 Expression in Adult Participants With Multiple Myeloma (MM)

MEDICI
Start date: July 7, 2021
Phase:
Study type: Observational

Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood cells). Most trial participants with MM relapse (cancer has come back) or become non- responsive to treatment and remission gets shorter after each line of treatment. This is a study to assess t(11;14) and BCL2 expression in adult participants with newly diagnosed and relapsed/refractory (R/R) MM. Approximately 500 adult participants with newly confirmed or relapsed/refractory (R/R) multiple myeloma (MM) will be enrolled in around 15-20 countries. Participants will receive standard of care while participating in this study. No drug will be administered as a part of this study. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide bone marrow and blood samples.

NCT ID: NCT04720534 Completed - Clinical trials for Severe Hypertriglyceridemia

Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia

SHASTA-2
Start date: May 31, 2021
Phase: Phase 2
Study type: Interventional

The purpose of AROAPOC3-2001 is to evaluate the efficacy and safety of ARO-APOC3 in participants with severe hypertriglyceridemia. Participants will receive 2 subcutaneous injections of ARO-APOC3.

NCT ID: NCT04720404 Completed - Mindfulness Clinical Trials

Mindful Prevention of Psychopathology in Healthcare Workers During the COVID-19 Crisis (COVID-19 MindPreP)

Start date: June 23, 2020
Phase: N/A
Study type: Interventional

The current study will be a randomized controlled trial (RCT) investigating an adapted online Mindfulness-Based Stress Reduction (MBSR) program versus daily online self-help mindfulness exercises, in preventing incident/prevalent psychopathology in healthcare workers allocated to work with COVID-19 patients. Outcome measures include depression, anxiety, somatoform symptoms, post-traumatic stress, insomnia, substance abuse, post-traumatic growth and positive mental health. The study also aims to explore possible working mechanisms such as perseverative thinking, mindfulness skills and self-compassion. The study will have a follow-up duration of 7 months from baseline.

NCT ID: NCT04720222 Completed - Clinical trials for Urinary Incontinence

Detectability of the Bladder With an Early Prototype of the Bladder Sensor

Start date: April 29, 2021
Phase: N/A
Study type: Interventional

This is an explorative, monocentric, feasibility study to evaluate the detectability of the bladder in healthy subjects by ultrasound monitoring with the early prototype of a future bladder sensor, which is intended for use for an individual suffering from urinary incontinence.

NCT ID: NCT04719182 Completed - Covid19 Clinical Trials

Practice of Adjunctive Treatments in Intensive Care Unit Patients With COVID-19

PRoAcT-COVID
Start date: September 1, 2020
Phase:
Study type: Observational

Rationale Many patients with coronavirus disease (COVID-19) need hospital admission for oxygen supplementation. A substantial number of patients need intensive care unit (ICU) admission for escalation of care. ICU doctors and nurses are struggling to provide the best care for patients with COVID-19. Practice of adjunctive and supportive treatments remains uncertain. Objective To determine and compare practice of adjunctive and supportive treatments for COVID-19 in the Netherlands, and to determine their independent associations with outcome. Hypotheses Practice of adjunctive and supportive treatments for COVID-19 varies substantially. Adjunctive and supportive treatments have an independent association with outcome in ICU patients with COVID-19. Study design National/international, multicenter, retrospective observational study. Study population Intensive care unit (ICU) patients with COVID-19. Methods In this study we will collect data on diverse treatments during the first 28 days in ICU, including (a) the types of oxygen support* and awake prone positioning; (b) the types of ventilatory support, (c) rescue therapies for refractory hypoxemia during invasive ventilation (prone positioning, ventilator adjustments, continuous muscle paralysis, and extracorporeal membrane oxygenation); (d) adjunctive treatments, including thromboprophylaxis and anticoagulation, antiviral and immunomodulating therapies, and (e) experimental supportive treatments. Outcomes include duration of each adjunctive treatment, duration of ventilation, incidence of tracheostomy, duration of stay in ICU and mortality until day 90. Study endpoints A combination of adjunctive treatments, including types of oxygen support, ventilatory support and rescue therapies for refractory hypoxemia during invasive ventilation (primary), other adjunctive and supportive treatments, tracheostomy rate; duration of ventilation and ventilator-free days and alive at day 28 (VFD-28), duration of ICU and hospital stay, and ICU, hospital and 90-day mortality. Nature and extent of the burden and risks associated with participation, benefit and group relatedness Retrospective collection of data regarding adjunctive treatments, and clinical endpoints is without risk for ICU patients. *In a subset of patients we will collect granular data (every two hours) regarding oxygenation (FiO2, inspiratory tidal volume, air flow, respiratory rate, SpO2, PaO2, and PEEP) over the first 2 full calendar days of ICU admission. The primary endpoint of this sub-analysis will be the amount of oxygen used with different respiratory support interventions. The statistical analysis plan for the analysis of these data that were collected in two ICUs that participated in the national study, and one additional ICU in Spain is uploaded in the document section (filename Statistical Analysis Plan PROXY-COVID)

NCT ID: NCT04714944 Completed - Obesity Clinical Trials

Fiber and Insulin Sensitivity

Start date: February 5, 2021
Phase: N/A
Study type: Interventional

Based on previous research of the investigators group, the investigators hypothesize that slowly fermentable fibers with a high degree of polymerization that increase SCFA specifically in the distal colon are expected to have higher potential for influencing host metabolism and metabolic health by improving adipose tissue function, preventing lipid overflow and hepatic as well as skeletal muscle fat accumulation thereby improving insulin sensitivity. The objective of this randomized clinical trial is to test, whether the a dietary fiber product containing different physiological acting fibers reverses peripheral and hepatic insulin resistance in overweight/obese insulin resistant participants.