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NCT ID: NCT05574452 Not yet recruiting - Clinical trials for Anterior Cruciate Ligament Injuries

Patient Specific Instrumentation in ACL Reconstruction

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

Rationale: In anterior cruciate ligament (ACL) reconstruction, anatomical femoral tunnel positioning has proven to be difficult with current techniques. Limited visibility during surgery and high interpersonal variability are mainly responsible for non-anatomical femoral tunnel positioning. Non anatomical tunnel positioning can lead to long term failure of the reconstruction. In order to obtain an accurate and constant anatomical femoral tunnel position during ACL reconstruction, a patient specific surgical guide has been developed. Objective: to assess the accuracy of the newly developed patient specific femoral aimer used during ACL reconstruction. Study design: pilot study Study population: 10 subjects (>16 years of age ) with ACL injury, requiring ACL reconstruction. Intervention: all subjects will undergo ACL reconstruction in which a patient specific surgical guide is used for femoral tunnel positioning. Main study parameters/endpoints: the main study parameter is the difference between the planned femoral tunnel position and the achieved tunnel position. This difference is quantified in both mm (translation) and degrees (rotation). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No additional perioperative risks are associated with participation. Based on previous cadaver experiments, the accuracy of the patient specific, 3D printed femoral aimer is high. Subjects will undergo 1 postoperative MRI which will take place during a routine scheduled follow up visit.

NCT ID: NCT05572710 Recruiting - Clinical trials for Aortic Valve Stenosis

Avalus European Registry - an Observational Study to Evaluate Safety and Efficacy in a Real World Population

Avalus
Start date: June 10, 2020
Phase:
Study type: Observational [Patient Registry]

This is a prospective, observational, single-arm, multi-center registry of patients undergoing bioprosthetic aortic valve replacement with the Avalus valve. This prospective registry aims to examine the outcome and performance of surgical aortic valve replacement with the Avalus pericardial bioprosthesis.

NCT ID: NCT05572515 Recruiting - Clinical trials for Relapsed or Refractory Multiple Myeloma

A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma

MajesTEC-9
Start date: March 29, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd.

NCT ID: NCT05572359 Recruiting - Clinical trials for Osteo Arthritis Knee

Cryo and Compression Therapy After TKA and UKA

Start date: May 25, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the use of a cold and compression brace during the first 6 weeks after surgery in patients who had a total or partial knee replacement. The main question[s] it aims to answer are: - What is the effect of the use of cryo- and compression therapy during the first 6 postoperative weeks after knee replacement surgery on pain in rest? - What is the effect of the use of cryo- and compression therapy during the first 6 postoperative weeks after knee replacement surgery on pain while loading, opioid use, functioning, patient satisfaction and general health, and do participants comply with the therapy? Participants will be asked to use the cold and compression brace during the six weeks after surgery five times a day, for a maximum of 20 minutes. Researchers will compare with usual care to see the effect on pain, opioid use, functioning, satisfaction and general health.

NCT ID: NCT05570643 Completed - Clinical trials for Sepsis, Endotoxemia, Immunosuppression

The Effects of Human Endotoxemia on Functional Capacity of Hematopoietic Stem and Progenitor Cells

LPS-BM
Start date: January 5, 2018
Phase: N/A
Study type: Interventional

We will investigate whether human endotoxemia induces changes in human bone marrow cells and their downstream effector cells. To comprehensively investigate underlying mechanisms behind functional and transcriptional changes in these cell types, we will use state-of-the-art systems biology techniques, including single cell transcriptomics (epi)genetics, and metabolomics.

NCT ID: NCT05570474 Recruiting - Clinical trials for Bariatric Surgery Candidate

Effect of Protein Supplementation on Fat Free Mass Preservation After Bariatric Surgery

PROMISE
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

This double blind randomized placebo controlled trial investigates the effect of protein supplementation on fat free mass loss in patients who underwent a Roux-en-Y gastric bypass.

NCT ID: NCT05570305 Enrolling by invitation - Clinical trials for Chronic Kidney Diseases

Zibotentan and Dapagliflozin in Patients With Type 2 Diabetes and Elevated Albuminuria

ZODIAC
Start date: October 6, 2022
Phase: Phase 2
Study type: Interventional

The aim of this study is to test the hypothesis that the effects on albuminuria of combination treatment with the endothelin receptor antagonist zibotentan and SGLT2i dapagliflozin are complimentary and additive while the fluid retaining effects of zibotentan can be mitigated by dapagliflozin.

NCT ID: NCT05569707 Not yet recruiting - Melanoma (Skin) Clinical Trials

MR Lymphography and Magnetic Sentinel Lymph Node Biopsy in Melanoma Patients

MelaDiff
Start date: January 2023
Phase: N/A
Study type: Interventional

The sentinel lymph nodes (SLNs) are the first lymph nodes (LNs) to drain the tumor site and therefore the first LNs to bare metastases. Hence the importance to investigate these LNs for the best treatment strategy. Current-standard-of-care for melanoma patients with a melanoma stage of pT1b or higher, involve a surgical procedure, referred to as SLN biopsy (SLNB). The SLNB procedure involves a combined detection procedure using a radio-active tracer and blue dye followed by surgical dissection and evaluation of the LNs at the histopathology department. Due to the use of radioisotopes, this procedure suffers from several disadvantages such as limited availability, strict rules and regulations, degradation time in patient and radioactive load for user and patient. To overcome the limitations of a radioactive tracer, a magnetic SLNB was developed which is facilitated by super paramagnetic iron-oxide (SPIO) nanoparticles. This potentially offers numerous benefits making surgery planning more flexible: no exposure to radiation, easy accessibility of the tracer, long shelf life and long half time in the patient. However, the currently available magnetometer for intraoperative detection of SPIO-enhanced LNs is hampered by a relatively low detection depth, biological noise, and effects of surgical equipment. Therefore, surgeons need to switch to plastic or carbon equipment and the system needs to be balanced prior to each measurement, which increases the surgery time. A new and effective way to localize SPIOs is differential magnetometry (DiffMag). This patented detection principle, developed by MD&I group at University of Twente (UT), utilizes the nonlinear magnetic response of nanoparticles. An additional advantage of SPIOs is their visibility on MRI, which could provide mapping the SLNs preoperatively. Especially in patients with melanomas on the abdomen or back this would be very useful to see which lymph node stations are connected to the melanoma. In addition, studies have shown that SPIOs are absorbed into lymph nodes in different ways, depending on the presence of metastases. SPIO-enhanced MR lymphography could therefore provide an opportunity for a non-invasive preoperative assessment of nodal status. In this pilot study the investigators want to evaluate the clinical use of the DiffMag handheld probe. Moreover, the investigators want to map the lymph nodes (metastases) preoperatively using MR lymphography.

NCT ID: NCT05569252 Completed - Clinical trials for Pseudoxanthoma Elasticum

A Study of DS-1211b in Individuals With PseudoXanthoma Elasticum

Start date: October 20, 2022
Phase: Phase 2
Study type: Interventional

This study was designed to evaluate the safety, tolerability, pharmacodynamics (PD) of DS-1211b, and pharmacokinetics (PK) in individuals with Pseudoxanthoma elasticum (PXE). PXE is a rare disease that is associated with significant risks of visual impairments and comorbidity from peripheral and cardiovascular diseases, and adversely impacts the quality of life in afflicted individuals.

NCT ID: NCT05568706 Recruiting - RSV Infection Clinical Trials

A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications.

RSVHR
Start date: November 29, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase 2b, randomized, double-blind, placebo-controlled study of EDP-938 administered orally for the treatment of non-hospitalized adult subjects with confirmed RSV infection who are at high risk for complications after RSV infection.