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NCT ID: NCT04109066 Completed - Breast Cancer Clinical Trials

Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer

CheckMate 7FL
Start date: November 20, 2019
Phase: Phase 3
Study type: Interventional

A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early stage breast cancer.

NCT ID: NCT04108065 Completed - Clinical trials for Gestational Diabetes Mellitus

The Role of Pregnancy-induced Gallbladder Dysmotility in the Pathophysiology of Gestational Diabetes Mellitus

Start date: October 2, 2019
Phase:
Study type: Observational

The primary aim of the study is to evaluate postprandial gallbladder emptying and plasma concentrations of the glucose-lowering and satiety-promoting gut hormone glucagon-like peptide 1 (GLP-1) during third trimester of pregnancy in women with gestational diabetes mellitus (GDM) compared with age and body mass index (BMI)-matched pregnant control women with normal glucose tolerance (NGT).

NCT ID: NCT04107623 Completed - Surgery Clinical Trials

Quantitative Fluorescent Guided Robotic Surgery for Cancer of the Gastroesophageal Junction

Start date: June 16, 2020
Phase: N/A
Study type: Interventional

The investigators also aim to use our previously described quantifying method (q-ICG), to evaluate changes in gastric perfusion, during resection of cancer in the gastroesophageal junction (GEJ) and if a change in the operative technique influences microvascular flow in the gastroesophageal (GE) anastomosis.

NCT ID: NCT04100902 Completed - Clinical trials for Allergic Asthma Due to Dermatophagoides Pteronyssinus

The Effect of Allergen Immunotherapy on Anti-viral Immunity in Patients With Allergic Asthma

VITAL
Start date: January 20, 2020
Phase: Phase 4
Study type: Interventional

Aim: To investigate the possible immune modulatory effects of allergen immunotherapy (AIT) on respiratory immunity in patients with allergic asthma (AA). Background: Allergic sensitization to aeroallergens is a common co-morbidity in asthma that is associated with more frequent and severe asthma attacks. The investigators have recently shown that patients with allergic asthma also have an increased risk of pneumonia, and hence allergy in asthma may be associated with a relative respiratory immunodeficiency. However, the increased risk was obliterated in patients treated with AIT. Methods: Patients with asthma sensitized to house-dust mite (HDM) is enrolled in a randomized, double-blind, placebo-controlled study of HDM-AIT. Patients will be scheduled for 9 visits through 8 months including, randomization to 6 months of treatment with either HDM-AIT (Acarizax/Odactra) or placebo. Primary interferons (IFN) type I and III will be investigated in human bronchial epithelial cells as the primary outcome. Secondary outcomes such as: Inflammatory cytokines, immunologic phenotype and immunohistochemistry will be investigated in bronchial biopsies, blood, bronchoalveolar lavage fluid, sputum and HDM-patch biopsies as well as a thorough respiratory and allergic evaluation. Expected outcomes: The investigators expect that, patients with AA have 1) decreased production of anti-viral type I and III IFN and that AIT increases these measures. 2) Anti-bacterial response is reduced through IL12, ß-defensin and IFN-γ and that AIT increases these measures. 3) Lastly, the investigators expect that T-cell response is dysregulated (Th1↓1/Th2↑) in patients with AA and that these findings are modulated in an immuno-protective direction after AIT. Perspectives: This project will expand our understanding of the clinical significance of allergy in asthma in a completely novel direction and show how AIT may modulate the immune response to prevent infections.

NCT ID: NCT04099706 Completed - Chronic Pain Clinical Trials

Treatment of Chronic Postherpetic Pain With Autologous Fat Grafting - A RCT

Start date: September 19, 2019
Phase: N/A
Study type: Interventional

This randomized clinical trial investigates the possible beneficial effect of autologous fat grafting on postherpetic neuralgia.

NCT ID: NCT04098913 Completed - Screen Time Clinical Trials

Short-term Efficacy of Reducing Screen-based Media Use

SCREENS
Start date: June 6, 2019
Phase: N/A
Study type: Interventional

The purpose of this randomized controlled trial is to investigate the short-term efficacy of reducing recreational screen-based media use on physical activity patterns, sleep, physiological stress in families at least one child between 6-10 years of age.

NCT ID: NCT04098549 Completed - Type 1 Diabetes Clinical Trials

The Effect of Rapid and Slow Glucose Fall on the Subsequent Glucose Production in People With Type 1 Diabetes

RaSlo-19
Start date: September 12, 2019
Phase: N/A
Study type: Interventional

In the effort of better understanding the glucose control in people with type 1 diabetes, in-depth insight into the physiology of hepatic glucose production and its influencing factors is essential. Previously, a number of potential influencing factors of hepatic glucose production have been investigated, including insulin-on-board, low carbohydrate diet, preceding ethanol intake, exercise and multiple stimulations of hepatic glucose production. Previous post-hoc analysis of dual-hormone closed-loop systems has indicated that the rate of fall in blood glucose influences the following stimulation of hepatic glucose response. However, the rate of fall in blood glucose is highly related to insulin levels, which may explain those findings. Thus, in this study the investigators want to examine whether the different rates of fall in blood glucose with similar insulin levels on board affect the hepatic glucose response in individuals with type 1 diabetes. In the study, which will be conducted at Steno Diabetes Center Copenhagen, participants will complete two study visits. On each visit, a hypoglycemic clamp technique will be used to lower the blood glucose levels of the participants (using either a rapid or slow decline rate), whereupon hepatic glucose production will be stimulated using low-dose glucagon. The study days are divided into four phases: 1) preparation phase, 2) hyperinsulinemic euglycemic phase (stabilization of blood glucose), 3) hyperinsulinemic hypoglycemic phase (rapid or slow decline in blood glucose) and 4) post-glucagon administration phase. This design will allow the investigators to examine whether differences in hepatic glucose response exist depending on preceding rate of fall in blood glucose. We hypothesize that the rate of fall in blood glucose does not affect the hepatic glucose production.

NCT ID: NCT04097288 Completed - Clinical trials for Stress Urinary Incontinence

Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects

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

This study will investigate if citalopram, a selective serotonin reuptake inhibitor, is reducing the opening pressure of the urethra and possibly causing or worsening stress urinary incontinence. Reboxetine, a norepinephrine reuptake inhibitor, is known to increase urethral opening pressure through actions on adrenoceptors in Onuf´s nucleus and will act as an active control. Furthermore, this study is performed to explore the effects of reboxetine and citalopram on the opening pressure of the anal canal.

NCT ID: NCT04093024 Completed - Clinical trials for Lung Diseases, Interstitial

A Study to Find Out How Nintedanib is Taken up in the Body and How Well it is Tolerated in Children and Adolescents With Interstitial Lung Disease (ILD)

InPedILD®
Start date: December 3, 2019
Phase: Phase 3
Study type: Interventional

The main objective of the study is to evaluate dose-exposure and safety of nintedanib in children and adolescents with fibrosing Interstitial Lung Disease (ILD).

NCT ID: NCT04091334 Completed - Dyspnea Clinical Trials

Monitoring Patients With Shortness of Breath With Repeated Ultrasound Examinations

MODUS
Start date: October 9, 2019
Phase: N/A
Study type: Interventional

Purpose of the study: The purpose of the trial is to investigate whether repeated ultrasound scans of the heart and lungs of patients with shortness of breath may help to optimize their treatment. This patient group is characterized by an extended hospitalization and a high mortality rate. Therefore, it is essential to be able to target the treatment in order to shorten length of stay, prevent readmissions, and improve survival in these patients. Ultrasound scanning used in this way is novel. The study method: Initially, all patients will receive standard evaluation and ultrasound of the heart and the lungs. Then the patients are randomly assigned into two groups. In one group, patients receive standard assessment and treatment. In the second group, the patients, in addition to standard examination and treatment, receive ultrasound scans of their heart and lungs after two hours and again fire hours after the first scan. After discharge, the subjects are followed for one year to evaluate what examinations and treatment they received during hospitalization, whether they have been readmitted or died.