Safety, Immunogenicity, Efficacy of Ad26.Mos4.HIV, MVA-BN-HIV and PGT121, PGDM1400, and VRC07-523LS...
HIVAcquired Immunodeficiency Syndrome5 moreA multicenter, randomized, parallel-group, placebo-controlled, double-blind, Phase 1/2a clinical study to investigate the safety, tolerability, immunogenicity and exploratory efficacy of a vaccine regimen consisting of an Ad26.Mos4.HIV prime and a boost with Modified Vaccinia Ankara (MVA)-BN-HIV in combination with broadly neutralizing antibodies (bNAb) PGT121, PGDM1400, and VRC07-523LS in human immunodeficiency virus type 1 (HIV-1)-infected study participants on suppressive anti-retroviral therapy (ART).
Mesenchymal Stem Cells for The Treatment of Frailty Syndrome
Frailty SyndromeThe clinical study with UMC119-06-05 is designed to investigate the safety in patients with frailty syndrome. This will be a dose escalation, open label, single-center study in adult with frailty syndrome. UMC119-06-05 is ex vivo cultured human umbilical cord tissue-derived mesenchymal stem cells product which is intended for treatment of frailty syndrome.
A Prospective Pilot Study to Assess the Efficacy of BOTOX-A in Patients With Low Anterior Resection...
Low Anterior Resection Syndrome (LARS>20)Refractory Medical Treatment After Rectal ResectionAfter rectal resection for cancer (with or without stoma), patients may have digestive sequelae. LARS (Low Anterior Resection Syndrome) includes bowel frequency, stool fragmentation, urgency, and faecal incontinence. The goal of this study is to test intra-rectal BOTOX-A on functional outcomes and quality of life of patients with LARS refractory to medical treatment at 3 months after surgery.
Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome....
Short Bowel SyndromeThe primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with SBS-IF.
The Role of Neuromodulators in Refractory Functional Dyspepsia
DyspepsiaFunctional Gastrointestinal Disorders2 moreThe study was designed to investigate the effect of central neuromodulators on refractory functional dyspepsia
A Study of Elaprase in Children and Adults With Hunter Syndrome (Mucopolysaccharidosis II) in India...
Hunter SyndromeThe main aim of this study is to learn more about the safety profile of Elaprase in Indian children and adults with hunter syndrome. Participants will receive Elaprase once per week over a 3-hour period which can be reduced to 1 hour as determined by the study doctor. Participants will need to visit the clinic weekly during the duration of the study.
A Study to Evaluate the Efficacy and Safety of Obinutuzumab, Ibrutinib, and Venetoclax in Patients...
Richter's SyndromeRichter's syndrome (RS) is a life-threatening complication of chronic lymphocytic leukemia (CLL). It is associated with a switch in histopathology and biology, generally with a transformation of the original CLL clone to diffuse large B-cell lymphoma (DLBCL). The development of RS is accompanied by the onset of B symptoms, rapid growth of lymphadenopathy, extra-nodal disease, significant elevations of lactate dehydrogenase (LDH), and associated multi-organ dysfunction from invasive or obstructive processes RS occurs in 2-10% of CLL patients with an incidence rate of 0.5% per year. The molecular pathogenesis of RS involves inactivation of the tumor protein p53 (TP53) tumor suppressor gene in 50-60% of cases and activating aberrations of NOTCH1 and myelocytomatosis oncogene (MYC) in about 30% of cases. . These distinct molecular footprints of RS are chemoresistance leading to an aggressive clinical course with low response rates and poor outcomes.Taking into consideration that in addition to the underlying aggressive disease, most RS patients are often at an advanced age and suffer from numerous other comorbidities. Additionally, intensive chemotherapy regimens are highly toxic to this population group and lead to excessive treatment-related morbidity. Enrolling DLBCL-RS patients in clinical trials is therefore justifiable, particularly those with RS that is clonally related to the predisposed underlining CLL disease. Due to the poor activity of immunochemotherapy, the possibility of using novel agents in the treatment of RS is of great interest. The toxicity and the efficacy of the combination of cluster of anti differentiation antigen 20 (anti-CD20) antibody (e.g. Obinutuzumab or Rituximab) with Ibrutinib and/or Venetoclax have been already reported in both relapsed and naïve patients with CLL. The use of these three agents in combination is highly active in CLL and has manageable side effects. In addition, recent reports showed that treatment with Ibrutinib or Venetoclax as a single drug are active in RS. Herein the investigators propose a phase 2, open-label, non-randomized, single arm, multi-center study aiming to assess the safety and efficacy with the combination of Ibrutinib, Venetoclax and Obinutuzumab in patients with RS .
Extracorporeal Photopheresis and Mogamulizumab for the Treatment of Erythrodermic Cutaneous T Cell...
Folliculotropic Mycosis FungoidesPrimary Cutaneous T-Cell Non-Hodgkin Lymphoma6 moreThis phase II trial studies the effect of extracorporeal photopheresis (ECP) and mogamulizumab in treating patients with erythrodermic cutaneous T cell lymphoma (CTCL), a type of skin lymphoma. CTCL is a rare type of cancer that begins in the white blood cells called T cells. Erythrodermic is a widespread red rash that may cover most of the body. ECP is a medical treatment that removes blood with a machine, isolates white blood cells and exposes them to ultra violet light, then returns the cells to the body. Mogamulizumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving mogamulizumab with ECP may work together to kill the tumor cells directly (with mogamulizumab) and boost immune response to cancer (with ECP).
Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation
Acute Leukemia in RemissionMyelodysplastic Syndromes6 moreThe aim of this study is to assess the Fecal Microbiota Transplantation (FMT) efficacy in the prevention of allogeneic hematopoietic stem cell transplantation (allo-HSCT) complications and particularly Graft versus Host Disease (GvHD). The hypothesis of this study is that allogeneic FMT may improve outcomes of these patients.
Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome - Outcomes and Mechanisms...
Rotator Cuff TendinosisRotator Cuff Tendinitis2 moreRotator cuff tendinopathy, one of the pathologies identified as part of the cluster of shoulder symptoms known as subacromial pain syndrome, is a common musculoskeletal shoulder condition. Resolution of pain and disability is poor despite treatment, with only about 50% reporting full recovery at 12 - 18 months. Prior studies suggest therapeutic exercise when used alone and with other interventions can have positive outcomes; however, not all patients with rotator cuff tendinopathy respond. Few studies have assessed the effects of exercise for individuals with chronic pain, especially brain driven mechanisms, thought to play a key role. In this study, we will use brain imaging to understand the mechanisms, identify predictors of a positive response to exercise, and the relationship to biomechanical and pain-related factors in patients with RC tendinopathy. The findings from this study will optimize the delivery and treatment response to exercise for individuals with shoulder pain.