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NCT ID: NCT05935202 Not yet recruiting - Clinical trials for Hereditary Red Blood Cell Disorder (Disorder)

Safety and Efficacy of Mitapivat Sulfate in Adult Patients With Erythrocyte Membranopathies

SATISFY
Start date: December 21, 2023
Phase: Phase 2
Study type: Interventional

This is a prospective exploratory multicentre pilot study designed to study the safety and efficacy of mitapivat in RBC membranopathies and CDAII

NCT ID: NCT05926349 Not yet recruiting - Urgent Surgery Clinical Trials

A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure

ANNEXA-RS
Start date: October 20, 2023
Phase: Phase 3
Study type: Interventional

The study will aim to find out if the drug andexanet alfa is safe and effective in preventing major bleeding during urgent surgery or invasive procedures. The study will compare the use of andexanet alfa to the usual care given at the study center.

NCT ID: NCT05921448 Not yet recruiting - Influenza, Human Clinical Trials

Vaccine Pandemic Preparedness Through Airway Immunology Characterization

VAXXAIR
Start date: May 1, 2024
Phase: Early Phase 1
Study type: Interventional

The study aims to compare the effectiveness of live attenuated influenza vaccines (LAIV) and intramuscular-inactivated vaccines (IIV) in healthy individuals aged 18-49. It will investigate cellular and humoral responses, identify immunological markers for targeted vaccine improvement, and establish a collaborative platform for accelerated immunological and clinical vaccine research.

NCT ID: NCT05914506 Not yet recruiting - Clinical trials for Progressive Fibrosing Interstitial Lung Disease

Hyperpolarized 129-Xenon MRI in Fibrosing Interstitial Lung Disease

Start date: September 1, 2023
Phase:
Study type: Observational

This project aims to investigate the potential of non-invasive imaging to identify and monitor the earliest signs and physiological effects of pulmonary fibrosis and resulting cardiac dysfunction in patients with fibrosing interstitial lung disease. Second, to evaluate baseline risk factors the progression and therapeutic responses to anti-fibrotic drugs.

NCT ID: NCT05909423 Not yet recruiting - Colorectal Cancer Clinical Trials

Combining Intratumoral Flu Vaccine and Systemic Pembrolizumab in Patients With Early pMMR Colorectal Cancer

FLU-IMMUNE
Start date: September 1, 2023
Phase: Phase 2
Study type: Interventional

Immune checkpoint inhibitor (ICI) treatment has produced striking results in patients with colorectal cancer (CRC) of the subtype deficient mismatch repair (dMMR). The majority of patients, however, have proficient MMR (pMMR) tumors, with limited effect of ICIs. The key difference between dMMR and pMMR tumors is the infiltration of cytotoxic T-cells. dMMR tumors have increased infiltration and thus increased efficacy from ICI treatment. The investigators conducted a proof of concept study where the investigators applied an intratumoral (IT) unaltered flu vaccine in ten patients with non-metastatic pMMR CRC. The intervention increased infiltration of cytotoxic T-cells and the immune checkpoint PD-L1, suggesting that IT flu vaccine primes pMMR tumors to ICI treatment. The investigators aim to test the combination of IT flu vaccine and ICI treatment in patients with non-metastatic pMMR CRC in a new trial. The hypothesis is that IT flu vaccine and ICI treatment will synergistically to induce cancer cell death.

NCT ID: NCT05900388 Not yet recruiting - Clinical trials for Venous Thromboembolism

A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolism (VTE)

XAPAEDUS
Start date: December 31, 2024
Phase:
Study type: Observational

This is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in children under 2 years old with venous thromboembolism (VTE). VTE is a condition in which blood clots form in the veins, usually in the leg. This can cause pain and swelling. The clot can also break apart and travel in the blood to the lungs where it can block the blood flow. This can be life threatening. Rivaroxaban is approved for doctors to prescribe to children with VTE, but there is limited information about how it is used, how well it works, and how safe it is in children under 2 years old. Children in this study are already receiving or will receive rivaroxaban or other currently used medicines for VTE from their doctor according to the approved product information. The purpose of this study is to collect information on the pattern of use and safety of rivaroxaban and other standard medicines for VTE in children under 2 years old. The main information that researchers will collect in this study: - Age, gender, and other information about the child and their illness - Type of VTE treatment given to the child - Occurrence of medically important bleeding and its severity Further information that researchers will collect: - Changes in the characteristics of the children given VTE treatment (e.g., changes in the age range of children given VTE treatment) and changes in the treatment pattern for VTE - Return of VTE symptoms - Types of doctors who prescribe VTE treatment and their set-up (e.g., special clinics versus hospitals) Besides this data collection, no further tests or examinations are needed in this study. The data for this study will be collected from electronic health records and health insurance claims data until 2026. Researchers will observe each child during treatment until: - end of the anticoagulation treatment period e.g. discontinuation of all study drugs, - their information is no longer available, or - the study ends.

NCT ID: NCT05843032 Not yet recruiting - Clinical trials for Head and Neck Cancer

3D Ultrasound, Specimen Examination by Surgeon, and MRI in Surgical Margin Assessment

Start date: May 15, 2023
Phase: N/A
Study type: Interventional

In the current protocol, application of 3D ex-vivo ultrasound, MRI, and clinical evaluation (palpation and examination) by the surgeon is proposed to analyze the margin status in tongue squamous cell carcinoma and correlate the results to the histopathology findings.

NCT ID: NCT05789719 Not yet recruiting - Clinical trials for Osteoarthritis, Knee

An Exploratory Clinical Study to Investigate the Effect of autoSTEM-OA and alloSTEM-OA in Participants With Knee Osteoarthritis

Start date: November 1, 2023
Phase: Phase 1
Study type: Interventional

A phase 1 exploratory clinical study to investigate safety, tolerance and efficacy of a single intra-articular injection of autoSTEM-OA or alloSTEM-OA in participants with mild to moderate knee osteoarthritis

NCT ID: NCT05785689 Not yet recruiting - Clinical trials for Postoperative Complications

Autonomous Nervous System Regulated Paediatric Anaesthesia With Dexmedetomidine or Placebo

ANNA
Start date: April 1, 2023
Phase: Phase 4
Study type: Interventional

The goal of this randomized, double blinded study is to examine in children whether postoperative agitation can be reduced. The main question it aims to answer is Will optimized, monitor guided analgesic treatment and dexmedetomidine reduce postoperative agitation Participants will receive a standard anaesthesia regimen and on top of that, a titrable remifentanil infusion guided via Mdoloris Anastasia nociception index (ANI) monitor will be added. Additionally, the patients will receive either bolus placebo or bolus dexmedetomidine. The postoperative agitation measured via the Richmond agitation and sedation scale (RASS) score, will be compared. Secondary outcome measures including carbon dioxide trends will be made.

NCT ID: NCT05774652 Not yet recruiting - Obesity Clinical Trials

LiPO Teen (the Lifestyle in Pregnancy and Offspring Teenagers

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

The study is a follow-up of a Randomized Controlled Trial (RCT) performed in 2007-10 - the "Lifestyle in Pregnancy" LiP study. The LiP study included 360 pregnant women with BMI ≥30 kg/m2 from Odense University Hospital and Aarhus University Hospital. The women were randomized to intervention with low-calorie diet and physical activity from gestational age 10-14 in pregnancy and until delivery - or to a standard care control group. The objective of the LiPO-Teen project is to perform a clinical follow-up study of the eligible 301 mothers who completed the trial until delivery with a liveborn child, and their 14 year-old offspring. The overall ambition is to understand whether lifestyle intervention in pregnancy prevents obesity and its complications across generations, with a specific focus on modifiable factors.