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NCT03949855
The primary objective of this study is to evaluate the effectiveness of belimumab and intravenous rituximab co-administration at inducing a complete or partial remission (CR or PR) compared to rituximab alone in participants with primary membranous nephropathy. Background: Primary membranous nephropathy (MN) is among the most common causes of nephrotic syndrome in adults. MN affects individuals of all ages and races. The peak incidence of MN is in the fifth decade of life. Primary MN is recognized to be an autoimmune disease, a disease where the body's own immune system causes damage to kidneys. This damage can cause the loss of too much protein in the urine. Drugs used to treat MN aim to reduce the attack by one's own immune system on the kidneys by blocking inflammation and reducing the immune system's function. These drugs can have serious side effects and often do not cure the disease. There is a need for new treatments for MN that are better at improving the disease while reducing fewer treatment associated side effects. In this study, researchers will evaluate if treatment with a combination of two different drugs, belimumab and rituximab, is effective at blocking the immune attacks on the kidney compared to rituximab alone. Rituximab works by decreasing a type of immune cell, called B cells. B cells are known to have a role in MN. Once these cells are removed, disease may become less active or even inactive. However, after stopping treatment, the body will make new B cells which may cause disease to become active again. Belimumab works by decreasing the new B cells produced by the body and, may even change the type of new B cells subsequently produced. Belimumab is approved by the US Food and Drug Administration (FDA) to treat systemic lupus erythematosus (also referred to as lupus or SLE). Rituximab is approved by the FDA to treat some types of cancer, rheumatoid arthritis, and vasculitis. Neither rituximab nor belimumab is approved by the FDA to treat MN. Treatment with a combination of belimumab and rituximab has not been studied in individuals with MN, but has been tested in other autoimmune diseases, including lupus nephritis and Sjögren's syndrome.
NCT06167733
Adult subjects with mild to moderate and moderate ED who meet the study eligibility criteria will be enrolled in the study. The enrolled subjects will be randomized by a 1:1 ratio to receive the Active or Sham VERTICA® treatment. Baseline assessments will include collection of demographic data, medical history, concomitant medications and baseline clinical examinations. The initial treatment session will be performed in a clinical setting simulating home use to determine proper device use and to evaluate device tolerability, followed by continued home use of the device for a total of 6 months. Patients will be instructed to attempt sexual activity periodically over the course of the study. Every time a sexual intercourse is attempted, the patient will be requested to complete an event log using validated assessments. Patients will present for monthly follow-up visits, during which safety will be evaluated and additional efficacy assessments will be performed.
NCT06792708
This is an observational study of LUMRYZ prescribed in clinical practice. Patients are asked if they would be willing to complete questionnaires over a 4-month period after starting LUMRYZ. The questionnaires ask about narcolepsy symptoms, experience with LUMRYZ, and quality of life.
NCT05550532
The purpose of this study is to evaluate the efficacy of aticaprant compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in adult participants with major depressive disorder (MDD) with moderate to severe anhedonia (ANH+) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
NCT04660344
This is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with placebo in participants with MIBC who are circulating tumour deoxyribonucleic acid (ctDNA) positive and are at high risk for recurrence following cystectomy.
NCT02875314
This is a prospective randomized clinical trial, to determine whether dose-intensive tandem Consolidation, in a randomized comparison with single cycle Consolidation, provides an event-free survival (EFS) and overall survival (OS). The study population will be high-risk patients (non-Wnt and non-Shh sub-groups) with medulloblastoma, and for all patients with central nervous system (CNS) embryonal tumors completing "Head Start 4" Induction. This study will further determine whether the additional labor intensity (duration of hospitalizations and short-term and long-term morbidities) associated with the tandem treatment is justified by the improvement in outcome. It is expected that the tandem (3 cycles) Consolidation regimen will produce a superior outcome compared to the single cycle Consolidation, given the substantially higher dose intensity of the tandem regimen, without significant addition of either short-term or long-term morbidities.
NCT07136467
This study is to assess the burden of disease in adolescent and adult participants with moderate or severe alopecia areata (AA), non-segmental vitiligo (NSV), or moderate to severe hidradenitis suppurativa (HS) in a large global real-world participant population.
NCT05139602
Hidradenitis suppurativa (HS) is a chronic and often painful inflammatory skin disease which includes the forming of lumps, abscesses and scars in areas of the skin such as under the breasts, under armpits, inner thighs, groin and buttocks. Despite the clinical benefit anti-tumor necrosis factor (TNF) therapy offers to patients with HS, there remains a significant unmet medical need for patients who fail to achieve adequate benefit with anti-TNF therapy. This study will compare lutikizumab (ABT-981) versus placebo for the treatment of adult participants with moderate to severe HS who have failed anti-TNF therapy. Lutikizumab (ABT-981) is an investigational drug being developed for the treatment of HS. In the Main Study, participants will be put in 1 of 4 groups, called treatment arms. There is a 1 in 4 chance that participants will be assigned to placebo. Around 160 adult participants with moderate to severe HS who have failed anti-TNF therapy will be enrolled in the study at approximately 50 sites worldwide. In the Sub-study, participants will be put in 1 of 2 groups, called treatment arms. Both arms will receive treatment at different dosing intervals. Around 40 adult participants with moderate to severe HS who are naïve to biologic therapy will be enrolled in the study at approximately 20 sites. In the Main Study, participants will receive subcutaneous injections of lutikizumab (ABT-981) or placebo every week for 16 weeks. In the Sub-study, participants will receive subcutaneous injections of lutikizumab (ABT-981) every week for the first 15 weeks, then either every week or every other week for 36 weeks. There will be an optional Long Term Extension (LTE) for participants who completed Week 52 of the Sub-study and, as confirmed by the investigator, have shown a therapeutic benefit to study drug. Participants would then received lutikizumab using the same assigned dosing regimen as that from Period 2 of the Sub-study for an additional 104 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires and diaries.
NCT01760005
The purpose of this study is to assess the safety, tolerability, biomarker, cognitive and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug slows the rate of progression of cognitive/clinical impairment or improves disease-related biomarkers.
NCT06647498
The purpose of this research study is to test the study drug, referred to as remternetug, to determine its effectiveness for the study treatment of asymptomatic (at risk) Alzheimer disease in individuals with AD-causing mutations. This study will also investigate the effects of remternetug on biomarkers (measures of the disease including brain scans, blood and spinal fluid tests), examine safety data to identify any potential benefits or risks, and examine how well participants can tolerate remternetug. Stage 1 will determine if treatment with the study drug prevents or reverses amyloid beta (Aβ) accumulation compared with placebo in participants with dominantly inherited Alzheimer's disease (DIAD). Stage 2 will evaluate the effect of early anti-amyloid treatment on downstream biomarkers of AD in treated participants compared to external control groups.
NCT06502366
The purpose of this study is to assess the PD equivalence of the approved asthma combination therapy, BDA, delivered using the proposed replacement propellant HFO compared with BDA delivered using the currently approved propellant HFA in participants with asthma.
NCT04537013
Multi-center, prospective, concurrently controlled, non-randomized, double-blind (patient and assessor). Treatment of large chondral lesions in the knee with microfracture plus the Chondro-Gide® ACC is non-inferior to treatment of small chondral lesions treated with microfracture alone.
NCT06952699
Narcolepsy without cataplexy or Narcolepsy Type 2 (NT2) is a lifelong condition that makes people very sleepy during the day, regardless of how much sleep they get at night. People with NT2 may fall asleep suddenly, have trouble staying awake during the day, or may not be able to sleep well at night. They may have difficulty thinking clearly, paying attention, or remembering things, during the day. These symptoms can make daily activities like driving, working, or caring for their families challenging, impacting their quality of life. Orexin is a chemical made in the brain that helps keep a person awake and alert. TAK-360 acts like orexin. Previous studies have shown that medicines that act like orexin may keep people awake. The main aim of this study is to learn how safe TAK-360 is and how well adults with NT2 tolerate it. Researchers also want to find out if TAK-360 can help people with NT2 stay awake and determine the right dosage needed to do that. Participants will be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo in the treatment period. The placebo is a pill that looks just like TAK-360 but does not have any medicine in it. Using a placebo helps researchers learn about the real effect of the treatment.
NCT06932081
This real-world, international registry aims to evaluate the current experience with sodium-glucose cotransporter 2 inhibitors (SGLT2i) in adult congenital heart disease (ACHD) patients by investigating the prescription patterns, safety, tolerability, and potential beneficial effects on heart failure-related outcomes.
NCT07217340
This is a feasibility study to test whether it is possible to deliver a program inspired by Tibetan Dream Yoga in a modern, accessible way. Dream Yoga is a set of contemplative practices that combine mental exercises during the day with techniques for becoming aware of dreaming within a dream (lucid dreaming) and engage in certain dream activities. The purpose of these practices is to help people explore and loosen rigid patterns of thought and behavior. In this study, the investigators are developing and testing a program that includes guided imagination, meditation, and lucid-dreaming practices, supported by virtual-reality experiences and home-based sleep-monitoring technology. Participants are randomly assigned to either the Dream-Yoga-inspired program or a comparison program focused on general health and sleep education. Because this is a feasibility trial, our main goals are to see whether people are willing and able to take part, whether they find the program acceptable, and whether the investigators can deliver it as planned. The investigators will also explore early signals of change in sleep, dreaming, and thinking. The long-term goal of this research is to determine if such interventions could be beneficial for supporting psychological well-being, improving sleep, and enhancing creativity and flexibility of thought.
NCT07409350
This study includes finalization of the LINKED social network intervention to improve PrEP and MOUD uptake among people who inject drugs (PWID) in collaboration with an Expert Advisory Board and staff (N=16) at The Sidewalk Project (TSP), followed by a Hybrid Type II cluster randomized trial of the LINKED intervention (versus an equal-attention control) among N=372 people who inject drugs, with 6- and 12-month follow-up assessment of PrEP and MOUD uptake. The investigators will also evaluate implementation outcomes to inform future sustainable implementation of LINKED in harm reduction organizations.
NCT07214272
This study is a prospective, post-marketing (Phase 4) non-registrational single-arm, open-label, multicenter study.
NCT04567680
Veterans with PTSD often have impaired social relationships and poor social support. The negative outcomes associated with poor social support are of particular concern for Veterans with PTSD, who often perceive the world to be dangerous, view their social support network as a threat to their safety, and avoid members of their support network in order to increase their perceived safety. The goal of this project is to evaluate the efficacy of Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD (ACT-SS), a treatment focused on helping Veterans with PTSD to increase social support with family relationships, partners, and peers by targeting maladaptive patterns of interpersonal difficulties, feelings of detachment from others, irritability, and avoidance of social situations. The primary aim of this study is to conduct a two-site randomized controlled trial of ACT-SS (n=75) vs. PCT (n=75), a common treatment for social support difficulties. If positive, this study will provide a critically-needed treatment for Veterans with PTSD to improve their social functioning and social reintegration in the community.
NCT03626038
This study is a multicenter, prospective, non-randomized, non-controlled post-market clinical follow-up study. The primary objective of this study is to confirm the safety and performance of the A.L.P.S. Proximal Humerus Plating System applied in proximal humerus fracture treatment.
NCT07061938
ACE1831 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment in subjects with Immunoglobulin G4 Related Disease (IgG4-RD)
