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NCT ID: NCT05841537 Recruiting - Crohn's Disease Clinical Trials

An Observational Study to Assess Change in Disease Activity and Adverse Events In Adult Participants With Moderate to Severe Active Crohn's Disease (CD)

APPRISE
Start date: June 9, 2023
Phase:
Study type: Observational

Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective risankizumab is in treating moderately to severely active CD in real world. Adverse events and change in disease activity will be assessed. Risankizumab is a drug approved for the treatment of CD. All study participants will receive risankizumab as prescribed by their study doctor in accordance with approved local label. Approximately 1000 participants will be enrolled worldwide. Participants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 36 months. There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care.

NCT ID: NCT05841030 Recruiting - Clinical trials for Depressive Disorder, Major

A Study in Participants With Major Depressive Disorder (MDD) With Anhedonia and Inadequate Response to Current Antidepressant Therapy Including a Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI)

VENTURA-RWE
Start date: April 28, 2023
Phase:
Study type: Observational

The purpose of this study is to assess the socio-demographic, disease-related and treatment-related characteristics, and the standard of care (SOC) treatment patterns of participants with major depressive disorder (MDD) with anhedonia with inadequate response to their current antidepressant treatments and treated according to the standard of care treatment.

NCT ID: NCT05840302 Recruiting - Clinical trials for Low Back Pain, Recurrent

Effectiveness of a Pain Neuroscience Education Programme on Physical Activity in Patients With Chronic Low Back Pain

END-LC
Start date: October 2, 2023
Phase: N/A
Study type: Interventional

Proposing ways to effectively counter chronic low back pain through non-drug intervention is a major public health issue due to the prevalence and health costs of this condition. The back school (BS) is based on spinal economics and a biomechanical model. A convergence of evidence indicates that this type of program does not bring any mid- or long-term benefit. Faced with this observation, a Pain Neuroscience Education (PNE) has been developed based on a biopsychosocial model. Chronic low back pain is the consequence of a complex dynamic of multifactorial origin where the body lesion is no longer the only cause of the pain. Studies have shown that PNE has a positive effect on pain perception. One of the limitations of these studies is that they do not allow objective measurement of physical activity performed at a distance from a therapeutic program for patients who have benefited from these educational programs. Yet, physical activity is an essential variable in health and more specifically in the fight against pain in patients with chronic low back pain. The investigators believe that physical activity is a key factor in improving the condition of patients with chronic low back pain. Consequently, physical activity is an indicator of success but also a guarantee for a lasting effect of educational treatment. In order to measure this physical activity, the use of activity monitor (connected watch) developed in recent years now makes it possible to collect data in an ecological manner that is more objective than the data collected via self-questionnaires. The main objective of the study is to measure the effectiveness of a PNE on physical activity three months after the intervention compared to BS in patients with chronic low back pain receiving a multidisciplinary rehabilitation program. The secondary aims are to compare effectiveness of PNE versus BS on pain, quality of life, kinesiophobia, pain catastrophizing, central sensitization at 3 months and at one year after the intervention. In addition, an exploratory analysis will be conducted to determine predictors of physical activity maintenance. The investigators expect to observe greater physical activity in patients who have received a PNE program compared to the physical activity of patients who have completed an BS program.

NCT ID: NCT05840211 Recruiting - Clinical trials for Stage IV Breast Cancer

Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy

ASCENT-07
Start date: May 8, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS).

NCT ID: NCT05839717 Recruiting - Clinical trials for Myeloproliferative Neoplasm

Determination of the Clonality Profile in Myeloproliferative Neoplasms and Association With the Thrombotic Complications (CLOJAK)

CLOJAK
Start date: June 19, 2023
Phase:
Study type: Observational

Myeloproliferative Neoplasms (MPN) are associated with an increased risk of thrombosis. Platelets, red blood cells (RBC), leukocytes and endothelial cells are involved in these complications. An association with the JAK2V617F allele burden assessed in leukocytes has also been suggested. In some patients the allele burden measured in platelets and red blood cells is higher than the one determined in leukocytes. Our project aims at associating the risk of thrombosis with the allele burden determined in the cell populations (platelets, red blood cells, granulocytes and endothelial cells) and identifying high-risk clonality profiles.

NCT ID: NCT05838768 Recruiting - Clinical trials for MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers

Study of HRO761 Alone or in Combination in Cancer Patients With Specific DNA Alterations Called Microsatellite Instability or Mismatch Repair Deficiency.

Start date: June 27, 2023
Phase: Phase 1
Study type: Interventional

The main purpose of the study is to evaluate the safety and tolerability of HRO761 and identify the recommended dose(s), i.e., the optimal safe and active dose of HRO761 alone or in combination with tislelizumab or irinotecan that can be given to patients who have cancers with specific molecular alterations called MSIhi (Microsatellite Instability-high) or dMMR (Mismatch Repair Deficient) that might work best to treat these specific cancer types and to understand how well HRO761 is able to treat those cancers.

NCT ID: NCT05838755 Recruiting - Pain Clinical Trials

A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain

NEPTUNE-17
Start date: September 20, 2023
Phase: Phase 2
Study type: Interventional

This is a multicenter randomized, double-blind, placebo-controlled phase 2 study to evaluate efficacy, safety, tolerability, pharmacokinetics, and target engagement of GSK3858279 in adult participants with chronic Diabetic Peripheral Neuropathic Pain (DPNP). The primary objective of the study is to assess the efficacy of GSK3858279 in participants with DPNP who have been unable to sufficiently manage their pain.

NCT ID: NCT05838742 Recruiting - Pain Clinical Trials

A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis Pain

MARS-17
Start date: September 13, 2023
Phase: Phase 2
Study type: Interventional

This is dose-finding study of GSK3858279 in participants with moderate to severe knee osteoarthritis (OA) pain. The purpose of this study is to investigate and provide the data necessary to select the optimal effective and safe dose(s) of GSK3858279.

NCT ID: NCT05837507 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Non-invasive Ventilation Exchange

ANEX
Start date: July 5, 2023
Phase: N/A
Study type: Interventional

The median survival of patients with amyotrophic lateral sclerosis (ALS) is 3 to 5 years and mortality is mainly related to respiratory failure. Non-invasive ventilation (NIV) and multidisciplinary management improve the quality of life and survival of patients. However, patients have mobility difficulties related to the progressive worsening of functional disabilities. The research team hypothesize that the use of a multimodal digital platform, including in particular telemonitoring of NIV and teleconsultation, will slow down the evolution of the disabilities of patients with ALS and improve their quality of life.

NCT ID: NCT05836844 Recruiting - Prolapse; Female Clinical Trials

Pragmatic Evaluation of Performance and Safety of the Anchorsure® Transvaginal Device for Surgical Treatment of Apical Prolapse in Women

APAS
Start date: May 11, 2023
Phase:
Study type: Observational

Pelvic Organ Prolapse affects 50% of parous women, and apical prolapse is one of the most common types of prolapse. Treatment for apical prolapse ranges from observation, non-surgical treatment or surgical repair. An anchoring device can reduce dissection and operative time and is meant to provide strong fixation whilst minimizing potential postoperative pain by avoiding neurovascular injuries. These potential advantages must be evaluated in terms of performance and safety. This cohort study will be on patients undergoing sacrospinous fixation with the Anchorsure® system with a follow-up of 36 months.