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NCT ID: NCT05507216 Recruiting - Ulcerative Colitis Clinical Trials

ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2

Start date: December 21, 2022
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors].

NCT ID: NCT05507203 Recruiting - Ulcerative Colitis Clinical Trials

ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1

Start date: October 10, 2022
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors].

NCT ID: NCT05507034 Recruiting - Chronic Pain Clinical Trials

Identifying Biomarkers for Chronic Pain After Breast Cancer Treatment.

sCANsens
Start date: October 4, 2022
Phase:
Study type: Observational

Up to 40% of women experience chronic pain after treatment for breast cancer, and this pain is often very disabling. However, chronic pain after breast cancer remains under-recognised and undertreated. An effective and patient-tailored approach of (chronic) pain after breast cancer indeed requires a thorough knowledge and evaluation of the pain. In daily clinical practice, however, guidelines for a comprehensive diagnosis of pain in cancer patients and survivors are lacking. Further research in this topic is crucial for an efficient, preventive as well as curative, approach of pain after breast cancer. Besides the high prevalence and the important impact of pain in this population, the breast cancer population is also an ideal population to study chronic pain and its natural time course in different stages, since most patients start pain-free, but almost half of them end up with chronic pain. Therefore, this study aims to map biomarkers (both predictive, prognostic and diagnostic) for chronic pain after breast cancer treatment. We will study possible biopsychosocial biomarkers in relation to (chronic) pain and monitor their temporal changes from the moment of diagnosis until 1 year after surgery. The potential biomarkers are situated within the medical imaging of the brain, measurements of pain sensitivity and psychological variables.

NCT ID: NCT05506332 Recruiting - Clinical trials for Acute Myeloid Leukemia, in Relapse

Treatment With ABT-199 (Venetoclax) and Purine Analogues in Relapsed/Refractory Acute Myeloid Leukemia

Start date: July 15, 2022
Phase: Phase 1
Study type: Interventional

Non-commercial, open-label interventional phase Ib study to assess the effectivity of the combination of venetoclax and 6-mercaptopurine in patients with relapsed or refractory AML.

NCT ID: NCT05506293 Recruiting - Quality of Life Clinical Trials

European Multicentre Registry of Percutaneous Paravalvular Leak Closure

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

Paraprosthetic cardiac valve leaks are a progressive complication after after surgical or percutaneous heart valve replacement. These leaks can lead to heart failure and/or life-threatening hemolysis. Percutaneous closure of para-prosthetic leaks has been developed as an alternative to surgery in high-risk patients. These procedures remain technically challenging with a significant risk of failure and complications, but this risk is improved since the development of dedicated prostheses and the increased experience of the operators. The data in the literature concerning percutaneous leak closure remain limited and disparate and mostly retrospective.The impact of the procedures on the quality of life of patients is not known. Beyond the technical aspects and the follow-up of major cardiovascular events, investigators also wonder what is the impact of these procedures on the quality of life of patients. Investigators hypothesize that even a partial reduction in paraprosthetic leakage may be associated with an improvement in quality of life through reduction of transfusion needs and/or reduction of dyspnea. A prospective study is warranted to assess the technical and clinical and clinical results of these procedures, together with the evaluation of the the possible benefit on the quality of life of the patients.

NCT ID: NCT05505448 Completed - Healthy Clinical Trials

A Trial to Learn if a COVID-19 Therapeutic is Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants

Start date: September 15, 2022
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to evaluate the safety and tolerability of REGN14284 in healthy participants, as measured by all treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs). The secondary objectives of the study are: - To assess the concentration-time profile of REGN14284 in serum - To assess the immunogenicity of REGN14284

NCT ID: NCT05503550 No longer available - Clinical trials for Relapsed or Refractory Multiple Myeloma

Pre-Approval Access Single Patient Request for Talquetamab in Relapsed or Refractory Multiple Myeloma

Start date: n/a
Phase:
Study type: Expanded Access

The purpose of this pre-approval access program is to provide talquetamab for the treatment of participants with relapsed or refractory multiple myeloma.

NCT ID: NCT05503316 Recruiting - Stroke Clinical Trials

The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System

Start date: September 5, 2022
Phase: N/A
Study type: Interventional

Persons with an injury of the central nervous system clearly experience motor impairments. Among the most commonly described consequences are gait abnormalities and impaired balance. Although these are undeniably linked, they are also influenced by other factors. A recent systematic review (Xie, 2022) reports impaired balance, the presence of depression or anxiety, and decreased function of the lower limbs as important risk factors for fear of falling in persons after a stroke. Also for people with a spinal cord injury, the fear of falling has a major impact on their level of participation and quality of life (Sing, 2021). Preventing falls and reducing fear of falling is an important part of neurological rehabilitation programs as it is known that fear of falling has a negative impact on the patient's activity level. This in turn will lead to an increased risk of falling and a negative effect on neurological recovery due to insufficiently practicing their balance while walking. Since 2019 the rehabilitation center of UZ gent offers GRAIL training. This device aims to train walking balance and gait adaptability in a virtual environment. Patients who are admitted and/or undergoing ambulatory rehabilitation at UZ Gent are given the opportunity to complete a 5-week training schedule on the GRAIL. Before and after this training intervention period, the investigators evaluate the gait pattern of these patients. After the training period, the patients also complete a questionnaire about their experience while training on the GRAIL and often also indicate that they become more confident in their own balance when walking. That is why the researchers now also want to measure this. Research questions: 1. Do people with high confidence in their balance when walking differ from those with low confidence in their balance when walking? 2. Does GRAIL training have a different effect on confidence in balance than traditional rehabilitation? To answer the 2nd research question, patients who follow the traditional rehabilitation (control group) also receive the same tests as the people who follow GRAIL training. Randomization (prepared in advance via a computer program) determines who will follow the GRAIL training and who will follow the traditional rehabilitation.

NCT ID: NCT05502263 Recruiting - Thoracic Cancer Clinical Trials

Interest of CPET to Predict Mortality and Complications of Lung Resection Candidates

Start date: May 1, 2022
Phase:
Study type: Observational

Anatomic lung resection is the treatment of choice for the management of cancerous lung nodules Non-Small-Cell Lung Carcinoma (NSCLC). Systematic functional evaluation can reduce the risk of mortality and morbidity of candidates. Scientific societies recommend a cardiac and spirometry evaluation (including pulmonary diffusion capacity). In this context, patients with FEV1 or less than 80% of the predicted value are subjected to a more thorough evaluation of the physical physical capacity by cardiopulmonary exercise test (CPET) to determine VO2 max (Brunelli et al 2009). Patients with a VO2 max <35% of predicted values or <10ml/kg/min, or a postoperative predicted value of DLCO or FEV1(ppoDLCO, ppoVEMS) less than 30% associated with a postoperative VO2max less than 35% or 10 ml/min/kg should be offered an alternative treatment option (Begum et al 2016). In contrast, a VO2max greater than 20ml/min/kg is considered at low surgical risk (Brunelli et al 2009). For patients with a VO2 max between 10 and 20ml/kg/min, operability depends on the extent of the resection. In this group of patients, other parameters measured with CPET could be used to optimize the selection of patients given the inability of some the inability of some patients to provide a maximal effort, thus resulting in a sub-maximal evaluation of physical capacity. The VE/VCO2 slope, ventilatory equivalents or chronotropic recovery are parameters classically used in classically used in heart failure and have recently been shown to be independent prognostic factors as independent prognostic factors for 90-day and 2-year mortality after anatomical lung resection. Moreover, these factors do not depend on the maximality of the test and could again help us to risk-stratify for a sub-maximal and therefore not optimal test.

NCT ID: NCT05502250 Recruiting - Hodgkin Lymphoma Clinical Trials

Tislelizumab, Gemcitabine and Cisplatin for R/R Hodgkin Lymphoma Followed by Tislelizumab Consolidation in Patients in Metabolic Complete Remission

HOVON164HL
Start date: July 14, 2023
Phase: Phase 2
Study type: Interventional

This trial investigates the efficacy and safety of the drug tislelizumab in combination with chemotherapy as a treatment for patients with R/R HL. Tislelizumab is given in combination with chemotherapy (gemcitabine and cisplatin) followed by consolidation with tislelizumab alone. The study primary question is whether this strategy works as well as the standard treatment with intensive chemotherapy and autologous stem cell transplant.