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NCT ID: NCT04818671 Active, not recruiting - Clinical trials for Generalized Myasthenia Gravis

Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis

ADAPTSC+
Start date: April 26, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and tolerability of efgartigimod PH20 SC 1000 mg, and the clinical efficacy, PD, pharmacokinetics (PK), immunogenicity, impact on the quality of life (QoL) of the participants, treatment satisfaction, and administration method preference, and the feasibility of self- and caregiver-supported administration of the SC injection. Treatment duration: 3-week treatment periods, repeated as needed with at least 28 days in between treatment periods Health measurements: total levels of immunoglobulin G (IgG), Acetylcholine receptor binding autoantibodies (AChR-Ab) levels, Myasthenia Gravis Activities of Daly Living (MG-ADL).

NCT ID: NCT04818502 Active, not recruiting - Clinical trials for Mitral Valve Regurgitation

Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation

RESOLVE-MR
Start date: May 4, 2021
Phase:
Study type: Observational

To evaluate the safety and performance of the Tendyne™ Mitral Valve System when used as intended in a contemporary, real-world setting.

NCT ID: NCT04817774 Active, not recruiting - Clinical trials for End Stage Renal Disease

Safety & Tolerability Study of Chimeric Antigen Receptor T-Reg Cell Therapy in Living Donor Renal Transplant Recipients

STEADFAST
Start date: March 17, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of TX200-TR101 and its effects on the donated kidney in living donor kidney transplant recipients. TX200-TR101 is a product made from a kidney transplant recipient's own immune cells, which are genetically modified and designed to help the transplant recipient's body accept their donated kidney and prevent their immune system from rejecting it.

NCT ID: NCT04812730 Active, not recruiting - Spinal Deformity Clinical Trials

Multimodal Bio-mechanical Analysis of Adult Spinal Deformity With Sagittal Plane Misalignment

ASD
Start date: January 2016
Phase: N/A
Study type: Interventional

A good understanding of the principles of balance is vital to achieve optimal outcomes when treating spinal disorders. A complex interaction of the neuromotor system and muscular recruitment is necessary for ergonomic balance and deliberate displacement of the human body. Sagittal plane misalignment in spinal deformities challenges balance mechanisms used for maintenance of an upright posture. The occurrence of postoperative complications after spinal deformity correction like under-correction of sagittal misalignment, postoperative reciprocal changes in thoracic kyphosis, proximal junctional kyphosis and failure of instrumentation are possibly due to the current state-of-the art inadequate diagnostic work-up. Investigators do not fully understand the roll of vision and exact strategy of recruitment of neuromuscular units (trunk, pelvis, lower limbs) in patients with sagittal plane misalignment during standing and walking. To understand this, a dynamic evaluation of individuals with spinal deformities is needed. Currently there is only very little research performed in the field of clinical balance tests and instrumented movement analysis in patients with spinal deformity. The challenge for future studies is to further unravel the relation between trunk and lower limb movements, grouped into functional movement patterns. Moreover, additional information on trunk and lower limb kinetics and muscle activity (using dynamic electromyography (EMG)) will highly contribute to the understanding of this functional relationship, and will provide more in-depth insights into compensatory mechanisms of the trunk versus the lower limbs and vice versa.

NCT ID: NCT04812535 Active, not recruiting - Clinical trials for SCC - Squamous Cell Carcinoma of Skin

Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC.

Start date: June 1, 2021
Phase: Phase 2
Study type: Interventional

This is an open-label, "non comparative", non-randomized, Phase II study. Patients will be enrolled in 2 treatment arms

NCT ID: NCT04812353 Active, not recruiting - Clinical trials for Foot and Ankle Osteotomy

Foot and Ankle Arthrodesis or Osteotomy With Io-Fix Type Fixation

Start date: April 1, 2014
Phase: N/A
Study type: Interventional

The recovery of foot and ankle arthrodesis and osteotomy is still plagued by the problem of delayed consolidation or even pseudo-arthrosis. To date, the foot and ankle unit of UZ Leuven is using a state of the art system, called the Io-Fix system, to optimize the biomechanical stability. However, the current literature lacks studies assessing and quantifying the advantages of the Io-Fix system. Objective presentations about the use of, and (early) results are currently missing. Therefore, the investigators want to take their responsibility to objectively investigate whether they can confirm and quantify the expected positive results of using the Io-Fix system. Subsequently, the investigators want to search for eventual unexpected problems with Io-Fix.

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: NCT04809467 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia

A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL)

topMIND
Start date: September 16, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this single-arm, open-label, Phase 1b/2a, multicenter basket study is to evaluate whether tafasitamab and parsaclisib can be safely combined at the recommended Phase 2 dose (RP2D) and dosing regimen that was established for each of the 2 compounds as a treatment option for adult participants with R/R B-cell malignancies.

NCT ID: NCT04809077 Active, not recruiting - Clinical trials for Rotator Cuff Arthropathy

Focus on the Humeral Component Following Reverse Shoulder Arthroplasty

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

Reverse total shoulder arthroplasty has been widely used in the treatment of rotator cuff arthropathy. Follow-up has historically focused on the glenoid component because of problems with fixation and scapular notching leading to functional failure. Since several patients have shown cortical thinning of the proximal lateral humeral cortex during follow-up, further research is recommended to evaluate the cause and clinical impact of these radiographic changes. The goal of this study is to collect long-term radiographic and clinical data in order to facilitate the identification of risk factors.

NCT ID: NCT04808700 Active, not recruiting - Clinical trials for Focal Cartilage Lesions

Prospective Interventional Clinical Trial of an MRI Based Patient Specific Focal Knee Resurfacing Implant

Episealer
Start date: January 2015
Phase: N/A
Study type: Interventional

Lesions in the cartilage are common disorders. Arthroscopy lavage and debridement micro fracturing, mosaic plasticity as well as osteochondral autograft transplantation (OATS) are methods used for treatment of the lesions. Some have shown to help the patients but there is an ongoing treatment gap especially for patients with knee lesions and early osteoarthritis. Episurf Medical has developed a Focal Knee Resurfacing (FKR) implant, the Episealer® implant. The implant is used for treatment of focal cartilage lesions of the lateral or medial femoral condyle in order to alleviate pain and improve range of motion. In this study, the investigators aims to establish if this implant is a viable option for focal cartilage lesions of the distal femur not responding, or not eligible for, biological treatment options (eg. microfracturing)