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NCT ID: NCT04841304 Active, not recruiting - Diabetes Mellitus Clinical Trials

Cardiac Arrhythmia in Patients With End-Stage Renal Disease

CADDY
Start date: June 1, 2021
Phase:
Study type: Observational

The study will examine the presence of cardiac arrhythmias in patients receiving hemodialysis and the role of diabetes, hypoglycemia and parameters related to uremia and the dialysis procedure. The study is designed as a prospective cohort study with 18 months follow-up. 70 patients receiving chronic hemodialysis will be recruited and equipped with implantable loop recorders (ILR): 35 patients with diabetes and 35 patients without diabetes. Data collection during the follow-up includes continuous monitoring of the heart rhythm by the ILR for the entire follow-up period, continuous glucose monitoring for 10 days every second month, and monthly collection of blood samples and dialytic parameters.

NCT ID: NCT04835402 Active, not recruiting - Clinical trials for Pancreas Cancer, Metastatic

Electroporation Potentiated Immunotherapy in Cancer

EPIC-1
Start date: May 26, 2021
Phase: Phase 2
Study type: Interventional

The study is investigating the efficacy and safety of combined irreversible electroporation (IRE) and checkpoint inhibition in metastatic pancreatic cancer.

NCT ID: NCT04826003 Active, not recruiting - Clinical trials for Metastatic Colorectal Cancer

Study To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Anti-Tumor Activity Of RO7122290 In Combination With Cibisatamab With Obinutuzumab Pre-Treatment

Start date: July 14, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, multicenter, Phase Ib study to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) in the weekly (QW) and/or every 3 weeks (Q3W) regimens, safety, tolerability, PK, immunogenicity, PD profile and to evaluate preliminary anti-tumor activity of RO7122290 in combination with cibisatamab Q3W after pretreatment with obinutuzumab, in participants with previously treated metastatic, microsatellite-stable colorectal adenocarcinoma with high CEACAM5 expression

NCT ID: NCT04823962 Active, not recruiting - Venous Leg Ulcer Clinical Trials

Effect of rhGM-CSF on the Healing of Venous Leg Ulcers

Start date: March 11, 2021
Phase: Phase 2
Study type: Interventional

The objective of this study is to examine whether local administration of the growth factor rhGM-CSF incorporated into a hydrogel, can accelerate wound healing when applied to venous leg ulcers, and whether this is safe.

NCT ID: NCT04811027 Active, not recruiting - HNSCC Clinical Trials

Combination Study With Eftilagimod Alpha (a Soluble LAG-3 Fusion Protein) and Pembrolizumab in Patients With Recurrent or Metastatic HNSCC

TACTI-003
Start date: August 27, 2021
Phase: Phase 2
Study type: Interventional

Evaluate the safety and efficacy of eftilagimod alpha in combination with pembrolizumab against pembrolizumab alone in 1st line metastatic or recurrent HNSCC with PD-L1 positive (CPS ≥1) tumors, and determine the efficacy and safety of efti plus pembrolizumab in patients with PD-L1 negative tumors.

NCT ID: NCT04805918 Active, not recruiting - Clinical trials for Behavior Problems in Early Childhood

Pedagogues Promoting Positive Parenting in a Home-visiting Program in At-risk Families: A RCT of VIPP-SD

Start date: March 15, 2021
Phase: N/A
Study type: Interventional

Supportive parenting is a strong predictor of positive outcomes for children, and harsh parenting is a risk factor for child development, especially for the child developing externalizing problems (overactive, oppositional, and aggressive behavior). Externalizing problems in preschoolers are predictive of a variety of problems in later childhood. Thus, parents are key targets for change in preventive programs with children at risk for developing externalizing problems. More than 95% of 2-6 year old Danish children spend an average of 7.5 hours, 5 days a week in a daycare setting, thus pedagogues are key frontline staff in the promotion of parental abilities and early childhood mental health. However, a recent Danish study shows that pedagogues experience a need for systematic skills and methods for intervening in families with a child at risk. Attachment-based programs enhancing parental sensitivity and parental sensitive discipline show promising results. This efficacy study examines the Video-feedback Intervention to Promote Positive Parenting and Sensitive Discipline (VIPP-SD)delivered by 22 VIPP-SD trained pedagogues at home-visits to 120 families with a child (1-6 years) identified to be at risk. Pedagogues are supervised by four VIPP municipality psychologists, thus promoting the cross-disciplinary collaboration. The results will point to future identification of families that may (and may not) profit from a pedagogue delivered VIPP-SD intervention, as well as to revise the intervention in order to maximizing its effect, i.e. point to changes to tailor intervention to the particular needs of different families in a Danish context.

NCT ID: NCT04798885 Active, not recruiting - Clinical trials for Mild Traumatic Brain Injury

Get Going After concussioN 2.0

GAIN2
Start date: May 12, 2021
Phase: N/A
Study type: Interventional

The study tests the promising results of a previous study (GAIN 1.0) in a larger RCT (GAIN 2.0) which takes place in the municipalities of Central Denmark Region where citizens live their daily lives and whose health- and social care systems support citizens who experience persisting PCS.

NCT ID: NCT04796493 Active, not recruiting - Clinical trials for Mesenteric Traction Syndrome

Objective Grading of MTS With LSCI and Thermography

MTS LSCI
Start date: March 16, 2021
Phase:
Study type: Observational

Mesenteric traction syndrome (MTS) is defined as hypotension, tachycardia and facial flushing in the first hour of surgery, caused by mesenteric traction/abdominal exploration. MTS occurs frequently during abdominal surgery, with incidence around 80 % during open surgery, and lower during minimally invasive surgery. MTS can be divided into different severities using the degree of facial flushing, with the most severe level of MTS being associated with increased postoperative morbidity. Today MTS is diagnosed and graded subjectively by the surgical team, with marked difficulty and limitations. Therefore the investigators developed a cut-off value using the Laser Speckle Contrast Imaging (LSCI), which the investigators wish to confirm in a new cohort, while also examining whether LSCI is interchangeable with digital thermography, which is simpler and cheaper to perfom. The investigators will measure facial perfusion during the first hour of surgery and take blood samples at predefined timepoints to use for biochemical verification of the different severities of MTS. Three cohorts we planned to include 45 open esophagectomies or gastrectomies 50 whipple surgery 20 robot assisted esophagectomies or gastrectomies These patients will be use in multiple articles examining different aspects of MTS One study examining LSCI and thermography for the identification and grading of MTS will use 60 patients undergoing open esophagectomy or gastrectomy or whipple surgery, in this study patients will not be excluded if they are found to be disseminated. However we ended up including 37 open esophagectomies - due to few patients undergoing open esophagectomy, this were included over a time period of almost 2,5 years 50 whipple 11 Robotic esophagectomies - due to LSCI being impossible to use on robotic esophagectomies and thermography being diffciult to fit on these patients and as such not being feasible

NCT ID: NCT04794101 Active, not recruiting - Clinical trials for X-Linked Retinitis Pigmentosa

Follow-up Gene Therapy Trial for the Treatment of X-linked Retinitis Pigmentosa Associated With Variants in the RPGR Gene

Start date: December 4, 2020
Phase: Phase 3
Study type: Interventional

A clinical trial of AAV5-hRKp.RPGR vector for participants with X-linked retinitis pigmentosa (XLRP)

NCT ID: NCT04793958 Active, not recruiting - Clinical trials for Metastatic Colorectal Cancer

Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)

Start date: March 15, 2021
Phase: Phase 3
Study type: Interventional

Study CA239-0006 is an open-label, randomized Phase 3 clinical trial comparing the efficacy of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation.