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NCT ID: NCT04084132 Recruiting - Tetralogy of Fallot Clinical Trials

Early Versus Later Re-valving in Tetralogy of Fallot With Free Pulmonary Regurgitation

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Tetralogy of Fallot (ToF) is a congenital heart defect with four major features including right ventricular outflow tract obstruction. About 25 children are born with this condition in Denmark every year. Corrective surgery is usually performed within the first year. In 50 % of patients, enlargement with a patch is necessary to achieve relief of the outflow tract obstruction. This however results in severe pulmonary regurgitation, which eventually leads to volume overload, right ventricular dysfunction and arrhythmia. To avoid these late complications, pulmonary valve replacement with a prosthesis if performed when patients meet the current guideline criteria. Most patients meet the guideline criteria for revalving when they are between 20 and 30 years of age. The current guidelines however, are based solely on retrospective studies and novel research reveals that in more than 50 % of patients who are treated according to current practice, right ventricular volumes and function as well as exercise capacity and burden of arrhythmia do not normalize or improve. 500 patients with ToF will be enrolled in a multicentre, cross-sectional study, which will yield information about the long-term outcomes after initial repair of ToF, as well as suggestions about the optimal timing for re-valving. Among patients included in the cross-sectional study, 120 patients with free pulmonary regurgitation, will be randomized evenly for early or later re-valving with at least 10-years of follow-up, for evaluation of long-term efficacy and safety of early re-valving.

NCT ID: NCT04083599 Recruiting - Melanoma Clinical Trials

GEN1042 Safety Trial and Anti-tumor Activity in Subjects With Malignant Solid Tumors

Start date: September 17, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

To evaluate the safety and anti-tumor activity of GEN1042 in patients with metastatic or locally advanced solid tumors.

NCT ID: NCT04079465 Recruiting - Respiratory Failure Clinical Trials

Automated Oxygen Control by O2matic to Patients Admitted With Acute Hypoxemia

O2MATIC-ACUT
Start date: October 1, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to examine if automated oxygen delivery with O2matic allows for faster weaning from oxygen supply and better oxygen control than manually controlled oxygen therapy for patients admitted to the emergency department with acute hypoxemia. Furthermore it will be tested if O2matic compared to manual control allows for earlier discharge.

NCT ID: NCT04077723 Recruiting - Clinical trials for Lymphoma, Non-Hodgkin

A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of RO7227166 in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab Administered in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

Start date: August 13, 2019
Phase: Phase 1
Study type: Interventional

This is a phase I/II, open-label, dose-escalation study designed to evaluate the safety, tolerability, and efficacy of RO7227166 in participants with relapsed/refractory Non-Hodgkin's Lymphoma (r/r NHL). RO7227166 will be administered by intravenous (IV) infusion in combination with obinutuzumab and in combination with glofitamab. A fixed dose of obinutuzumab (Gpt; pre-treatment) will be administered seven days prior to the first administration of RO7227166 and seven days prior to the first administration of glofitamab. This entry-into-human study is divided into a dose-escalation stage (Part I and Part II) and a dose expansion stage (Part III).

NCT ID: NCT04075305 Recruiting - Breast Cancer Clinical Trials

The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study

MOMENTUM
Start date: February 1, 2019
Phase:
Study type: Observational [Patient Registry]

The Multi-OutcoMe EvaluatioN of radiation Therapy Using the Unity MR-Linac Study (MOMENTUM) is a multi-institutional, international registry facilitating evidenced based implementation of the Unity MR-Linac technology and further technical development of the MR-Linac system with the ultimate purpose to improve patients' survival, local, and regional tumor control and quality of life.

NCT ID: NCT04073927 Recruiting - Clinical trials for Diabetes Mellitus, Type 1

Effect of Butyrate on Inflammation and Albuminuria in Patients With Albuminuria, Type 1 Diabetes and Intestinal Inflammation

Start date: August 5, 2019
Phase: N/A
Study type: Interventional

The objective is to assess the impact of 12 weeks supplement of sodium-butyrate twice daily or placebo on intestinal inflammation and albuminuria. A randomized, placebo-controlled, double-blind, two-site trial including 48 patients with type 1 diabetes, albuminuria and intestinal inflammation. Participants will be randomized 1:1 to active treatment or placebo for a period of 12 weeks. The primary endpoint is change from baseline to week 12 in intestinal inflammation, measured by fecal calprotectin.

NCT ID: NCT04070651 Recruiting - Lung Cancer Clinical Trials

Sleep and Immune Checkpoint Inhibitors

Start date: August 5, 2019
Phase:
Study type: Observational

Sleep disturbances are prevalent in cancer patients and linked to levels of fatigue and depressive symptoms with a major impact on quality of life. A growing body of evidence links sleep disturbances with various health outcomes, including increased risk of depression, cancer, and overall mortality. Inflammation is suggested to be an underlying mechanism both driving and maintaining the symptom cluster of sleep disturbance, fatigue and depressive symptoms, as well as being bi-directionally linked to sleep. The main purpose of the present study is to investigate the prevalence of sleep disturbance and its association with psychological and physical symptoms as well as the clinical response to ICI in non-small-cell lung cancer patients (NSCLC), with a secondary aim of exploring the role of inflammation.

NCT ID: NCT04063930 Recruiting - Clinical trials for Type 2 Diabetes Mellitus With Kidney Complications

The Effect of Sodium Zirconium Cyclosilicate on Albuminuria in Patients With Type 2 Diabetes and Hyperkalemia

ZIRCUS
Start date: October 2019
Phase: Phase 4
Study type: Interventional

To investigate whether concomitant treatment with Lokelma can improve the efficacy of standard blockade of the renin-angiotensin system in patients with type 2 diabetes, diabetic nephropathy and hyperkalemia.

NCT ID: NCT04058951 Recruiting - Hypertension Clinical Trials

Plant Versus Animal Dietary Protein and the Effect on Proteinuria

NYPRO
Start date: August 15, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate if a diet high in plant protein improves kidney function in patients with kidney insufficiency and diabetes and/or hypertension and/or glomerulonephritis. The study is a non-blinded, randomized, controlled, cross-over-design with two intervention periods of each 14 days. Between the two interventions periods there is a washout period of 14 days. The participants are randomized to start with an individualized diet plan containing either high amounts of animal protein or high amounts of plant protein.

NCT ID: NCT04058509 Recruiting - Tendinopathy Clinical Trials

Clinical Predictors of Extracorporal Shockwave Therapy Efficacy in Patients Presenting With Lateral Hip Pain

Start date: November 28, 2018
Phase: N/A
Study type: Interventional

This pragmatic clinical trial is considering the variable response to treatment outcome of individuals with Greater Trochanteric Pain Syndrome (GTPS). The aim of this study is to identify predictors of focused extracorporeal shockwave therapy (fESWT) efficacy in individuals with GTPS. Specifically, the ability of clinically applicable measurements including: Patient demographics, co-morbidity, oestrogen levels, pain characteristics, hip abductor strength, time to pain during single-leg stance test, low back pain, and immediate pain reduction to local anaesthetic injection at the trochanter major insertion of Gluteus medius (GMed) during walking.