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NCT ID: NCT04811092 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)

HYPERION
Start date: March 18, 2022
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in participants who are newly diagnosed with PAH and are at intermediate or high risk of disease progression.

NCT ID: NCT04810156 Recruiting - Clinical trials for Hepatitis, Drug-Induced

Treatment Efficacy of Corticosteroids and Mycophenolate Mofetil in Patients With Immune Related Hepatitis

I-HEP
Start date: April 7, 2021
Phase: Phase 2
Study type: Interventional

This clinical trial is to clarify and investigate the patterns of immune-related hepatitis and the optimal treatment choice for patients who are steroid-dependent. The project aims to prospectively characterize the various histopathological, biochemical, and phenotypical liver injury patterns induced by immune checkpoint inhibitors and the treatment responses to corticosteroids. Furthermore, the effect of adding a second-line immunosuppressive drug, either MMF in steroid-refractory or steroid-dependent cases will be explored and compared.

NCT ID: NCT04808388 Recruiting - Clinical trials for Paramyotonia Congenita

Using MRI in Patients With Non-dystrophic Myotonia to Access Muscle Contractility

Start date: February 2, 2021
Phase:
Study type: Observational

The aim of this project is (1) to investigate whether or not structural muscle abnormalities could be a consequence of the disorder and (2) to provide further clinical description of this rare phenotype. To do so, the investigators will (1) use Dixon MRI to quantify fatty infiltration in muscle tissue and compare it to muscle strength measurements from isometric dynamometry in order to access contractility and (2) describe the myotonic phenotype with simple squeeze test and questionnaires.

NCT ID: NCT04808258 Recruiting - Clinical trials for Embolic Stroke of Undetermined Source

Embolic Stroke of Undetermined Source, Continuous Electrocardiography and Transthoracic ECHOcardiography in Hospitalized Patients With Ischemic Stroke

ESECHO
Start date: November 27, 2020
Phase:
Study type: Observational

Transthoracic echocardiography (TTE) is recommended in patients with ischemic stroke when cardiac etiology is suspected to help plan secondary stroke management. However, discrepancy for specific clinical recommendation exists between cardiologists and neurologists, and data evaluating usefulness of TTE in unselected patients with cryptogenic strokes (CS) and embolic strokes of undetermined source (ESUS) are lacking. The investigators sought to evaluate the value of routinely performed echocardiography in consecutive CS/ESUS patients. The investigators will perform TTE as recommended by guidelines including agitated saline contrast and speckle-tracking to investigate potential implications for secondary stroke management. In addition, the researchers aim to evaluate the effectiveness of long-term continuous electrocardiogram (cECG) monitorering with newer Holter monitors to detect cardiac arrhythmia in patients with CS/ESUS. In this prospective study, the investigators aim to evaluate 500 consecutive patients, regardless of age, in sinus rhythm with acute IS and potential cardioembolic stroke (CES) or cryptogenic stroke (CS/ESUS) according to Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria. Strokes are determined by magnetic resonance imaging. The researchers will perform TTE as recommended by guidelines including agitated saline contrast and speckle-tracking to investigate potential implications for secondary stroke management. The investigators aim to explore underlying heart conditions and comorbidities among CES and ESUS patients. Data will include left atrium morphology, atrial septal aneurysm, valvular disease, mural thrombus and patent foramen ovale (PFO). Focus will be analysis of data on older patients, as some studies indicate that in ESUS patients >60 years of age, there is a higher prevalence of PFO in patients with low atherosclerosis and cardioembolic risk. This project can potentially guide cardiologists and neurologists, on common grounds, for stroke management of potential cardioembolic origin. Implications of referring all-comers with stroke of potential cardioembolic origin to echocardiography will be illustrated.

NCT ID: NCT04806412 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.

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

Oncological treatment of patients with disseminated non-small cell lung cancer (NSCLC) is depending on the status of programmed death-ligand 1 (PD-L1), anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR), so called oncodrivers. These can be measured in pleural fluid, but the prevalence is uncertain. In a prospective study, the research team aim to measure PD-L1, ALK and EGFR in patients with pleural fluid cytology positive for NSCLC to report the prevalence. Also, the study will investigate if the chance of obtaining oncodriver status is depending on the volume analysed and how the lack of oncodrivers influence the following work-up.

NCT ID: NCT04803422 Recruiting - Clinical trials for Complicated Appendicitis

Per Oral Versus Intravenous Postoperative Antibiotics After Surgery for Complicated Appendicitis.

PIPA
Start date: May 1, 2021
Phase: N/A
Study type: Interventional

The PIPA trial is a prospective, multicentre, cluster randomized cluster crossover non-inferiority study. We aim to test whether a three-day postoperative course of per oral antibiotics is non-inferior to a three-day postoperative course of intravenous antibiotics as standard care after laparoscopic surgery for complicated appendicitis in regards to the risk of postoperative intraabdominal abscess formation within 30-days

NCT ID: NCT04801615 Recruiting - Clinical trials for Necrotizing Soft Tissue Infection

Characteristics of Patients With Necrotizing Soft Tissue Infections

Start date: September 1, 2020
Phase:
Study type: Observational [Patient Registry]

To study the demographic characteristic of patients with necrotizing soft tissue infections.

NCT ID: NCT04801238 Recruiting - Pancreatitis Clinical Trials

preGallstep - A Clinical Pilot Trial

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

In Denmark, more than 7500 cholecystectomies are performed every year. Common bile duct gallstones (CBDS) are found in 3.4% to 18% of patients undergoing cholecystectomy. A two-step approach including endoscopic retrograde cholangiography (ERC) with stone extraction and papillotomy with subsequent laparoscopic cholecystectomy has become gold standard for treatment of CBDS in Denmark. However, ERC is associated with a high risk of complications and more than 50% of patients require multiple ERCs. Recent meta analyses find that a one-step approach might be superior in terms of safety, CBDS clearance rate, hospital stay, operative time, hospital cost and stone recurrence, but much more data is needed. The preGallstep trial is an investigator-initiated multicentre randomised clinical pilot trial with blinded outcome assessment investigating a novel one-step laparoscopic cholecystectomy with common bile duct exploration and stone extraction versus conventional two-step endoscopic retrograde cholangiography with stone extraction plus a subsequent laparoscopic cholecystectomy for patients with CBDS. After enrolment, the participant will be randomised to one of the two treatment approaches. Adult patients with imaging confirmed CBDS are eligible for inclusion. Potential postoperative complications will be assessed within 90 days following the procedure. The primary outcome is the proportion of serious adverse events (corresponding to a Clavien-Dindo score II or above) requiring re-intervention within 90 days of the initial procedure. This outcome will be used for a future sample size calculation. The sample size estimate, the inclusion rate and the estimated length of subsequent trial will be used to determine the feasibility of a large pragmatic and confirmatory trial. We hypothesize that the one-step approach will significantly reduce the risk of complications and number of treatments needed thereby making a difference to hundreds of people in Denmark each year.

NCT ID: NCT04798898 Recruiting - Clinical trials for Liver Metastasis Colon Cancer

Improving Survival of COlorectal LIver Metastases by RFA-mediated Immunostimulation

ISCOLIM
Start date: November 14, 2022
Phase: N/A
Study type: Interventional

To examine radio frequency ablation as a treatment supplement to stimulate immunogenicity and improve survival for patients undergoing curative-intent surgery for colorectal liver metastases.

NCT ID: NCT04798612 Recruiting - Colon Cancer Clinical Trials

Effect of Low-dose Interferon-alfa2a on Peri-operative Immune Suppression

IPOS
Start date: August 14, 2023
Phase: Phase 2
Study type: Interventional

The aim of this randomized double-blinded placebo-controlled phase 2 study is to determine efficacy of preoperative treatment with interferon-alfa2a in patients with pMMR colon cancer on perioperative immune suppression and infiltration of lymphocytes in the primary tumor.