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NCT ID: NCT05055648 Not yet recruiting - Esophageal Cancer Clinical Trials

PROton Versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy

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

The PROTECT trial will test the hypothesis that proton (PT) -enabled radiation dose reductions to sensitive, normal tissues will result in lower rates of treatment-related pulmonary complications in esophageal cancer compared to standard photon therapy (XT).

NCT ID: NCT05053139 Not yet recruiting - Haemophilia A Clinical Trials

A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors

Start date: December 3, 2021
Phase: Phase 3
Study type: Interventional

This study is investigating how Mim8 works compared to other medicines in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used for prevention of bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). When and how often participants will receive Mim8 is dependent on their previous treatment - but is otherwise decided by chance. The study will last for 72-124 weeks (17-29 months) depending on how long participants will be followed before it is decided when they start receiving Mim8 - the period before this is decided is called the 'run-in'. Participants will have 13-17 clinic visits. Mim8 will be injected into a skinfold on the stomach with a thin needle either once a week or once a month.

NCT ID: NCT05052385 Recruiting - Clinical trials for Steroid Refractory GVHD

ECP Combination Study

Start date: April 13, 2021
Phase:
Study type: Observational

Extracorporeal photopheresis (ECP) offers an alternative to standard immunosuppression and shows an immunomodulatory rather than an immunosuppressive effect, which is associated with less toxicities and side effects. Additionally ECP has been shown to allow tapering of steroids and immunosuppressant agents which should be a goal of GvHD therapy. ECP has been used for the management of GvHD since first described in 1994 and as its use has continued over the decades. The treatment was incorporated into a number of guidelines as a second line therapy in steroid refractory or steroid dependent GvHD patients. As well as being used in addition and after steroids, it is also used in combination with CNI Inhibitors, MMF and other immunosuppressant agents. However, despite the current widespread use of ECP in the treatment of patients with GvHD, clinical data from randomized studies is limited and small prospective and retrospective trials are the main evidence base .This is also the case for other commonly used immunosuppressant agents, which have been used in GvHD since ECP was introduced. The systematic review concluded that ECP is an effective therapy for oral, skin, and liver SR-cGVHD, with modest activity in lung and gastrointestinal SR-cGVHD. In the USA Ibrutinib is the only FDA approved agent for second line cGvHD therapy once steroid therapy has failed and Ruxolitinib had been approved in the USA for the treatment of steroid refractory GvHD. While studies have shown the effectiveness and safety of ECP in GvHD treatment, there is limited data to show how it is being used in combination with the recently approved agents. Using existing registry data targeting centres where the newer agents are being used and enhancing the capture of treatment data we believe we can undertake a larger scale study, which will include the new treatment protocols. The aim of the current study is to improve the evidence basis on the potential benefit of ECP use as treatment of GVHD.

NCT ID: NCT05051059 Not yet recruiting - Soft Tissue Sarcoma Clinical Trials

Assessment of the Functional Outcome and Quality of Life in Sarcoma Patients

QOL Sarcoma
Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Primary bone and soft tissue sarcomas are an exceptionally rare form of cancer, collectively accounting for only 1% of all malignancies diagnosed. Sarcomas often occur in the patients' extremities and treatment typically involves limb salvage surgery with bone and/or muscle resection. These surgeries often leave the patients with disfigurements, psychological trauma, and functional disabilities. Perhaps, the most difficult and life-altering decision that patients (and their parents) with primary bone sarcomas about the knee joint have to make, involves choosing the type of surgical procedure that will provide them with the outcome that meets their functional as well as aesthetic expectations. In literature, the quality of life for patients with osteosarcoma around the knee joint after three different surgical procedures, that is, amputation, endoprosthetic reconstruction and rotationplasty was evaluated. There was found that patients treated with rotationplasty showed significantly higher functional scores compared to the two other groups of patients. Also, researchers investigated the long-term quality of life after bone sarcoma surgery around the knee joint and found that, despite the functional disability, survivors were busy with work, study, relationships, and sometimes they have founded a family. Most published reports in the literature on assessment of gait in the lower-extremity sarcoma survivors were focused on bone sarcoma patients after wide resection and endoprosthetic reconstruction. To the knowledge of the investigator, there has been no published studies on gait analysis after resection of soft tissue sarcomas (STS) of the lower extremity. The rare and heterogeneous aspects of STS and the paucity of knowledge of movement strategies in these patients hinder the development of effective rehabilitation protocols for recovering movement after resection of STS in the lower limb.

NCT ID: NCT05050435 Recruiting - Clinical trials for Post-operative Cardiac Surgery

Early Cardiac Extubation After Cardiac Surgery

Start date: August 30, 2021
Phase:
Study type: Observational

The management of heart valve disease is constantly evolving over time. The minimally invasive approach (mini-thoracotomy and J-hemisternotomy) is one of the major surgical evolutions. It has many advantages: reduction of postoperative pain, reduction or even elimination of the risk of mediastinitis, ... This evolution of the surgical technique towards a less invasive process encouraged us to go in the same direction and to "lighten" our anesthetic techniques. From this perspective, immediate postoperative extubation, as already practiced in other centers, appeared to us to be feasible and probably beneficial for the patient. The investigators would therefore like to try to show that this practice is not inferior in terms of rhythmic and respiratory complications (re-intubation, need for non-invasive ventilation), the occurrence of postoperative pneumonia as well as in terms of of water balance.

NCT ID: NCT05050097 Not yet recruiting - Multiple Myeloma Clinical Trials

A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma

Start date: September 20, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens.

NCT ID: NCT05047679 Not yet recruiting - Clinical trials for Lumbar Radiculopathy

The Effectiveness of Pain Neuroscience Education in At-risk Patients Following Surgery for Lumbar Radiculopathy

B²EARS
Start date: September 30, 2021
Phase: N/A
Study type: Interventional

This study aims to assess the effectiveness of perioperative pain neuroscience education (PPNE) in patients who are at risk for unfavorable outcome following surgery for lumbar radiculopathy. Although most of these surgeries are successful, 23-28% of patients report chronic pain and disability following surgery. Many preoperative factors are associated with an unfavorable surgical outcome, including maladaptive cognitive and emotional factors. Yet, current preoperative education, which focuses on anatomy and biomechanics of the lumbar spine, is ineffective in changing those maladaptive factors. PPNE was introduced as an innovative therapy that addresses modifiable risk factors in patients undergoing surgery for lumbar radiculopathy. PPNE reconceptualizes pain, informs patients about their pain development and is well established for improving maladaptive cognitions in several chronic pain-populations. Hence, we hypothesize that PPNE will be more effective than perioperative biomedical education in improving postsurgical quality of life, pain, analgesic use and return to work in patients at risk for unfavorable outcome following surgery for lumbar radiculopathy. First, a multicentric randomized controlled trial will compare the therapy effects of PPNE to perioperative biomedical education in these at-risk patients. Next, the mediating role of changes in maladaptive cognitions, such as fear of movement and pain catastrophizing, on the therapy effect of PPNE will be investigated.

NCT ID: NCT05046470 Recruiting - Clinical trials for SARS-CoV-2 Infection

SARS-CoV-2 Transmission in Belgian Primary Schools of the Federation Wallonie - Bruxelles: An Epidemiological Pilot Study

DYNAtracs
Start date: January 14, 2021
Phase:
Study type: Observational

The investigators hypothesize that children are less likely to become infected in the school environment, compared to the household or outside the school setting. Primary schools do not play a major role in SARS-CoV-2 spreading. They hypothesize that incidence level in schools is mainly a consequence of community transmission. The incidence level in household and that the secondary attack rate in schools remains at least 5 times lower that the transmission level in households.

NCT ID: NCT05043883 Not yet recruiting - Clinical trials for Paroxysmal Atrial Fibrillation

Automated Assessment of PVI Using a Novel EP Recording System

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

A prospective, multi-center study with the CathVision Cube® system and the PVI Analyzer software in radiofrequency (RF) and cryo balloon procedures.

NCT ID: NCT05042492 Recruiting - Clinical trials for Osteoarthritis, Knee

The Post-operative Effect on Formation of Oedema After Total Knee Arthroplasty With or Without the Use of a Nerve Stimulator (the gekoTM Device)

Start date: January 14, 2021
Phase: N/A
Study type: Interventional

This study will investigate whether the recovery of muscle function of total knee arthroplasty is accelerated with the use of the gekoTM device along with its effect on reducing symptoms such as oedema and inhibition of the muscle function.