Phase 4 clinical trials in plain English

This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.

NCT03340506 · Official ClinicalTrials.gov record · Novartis Pharmaceuticals

Attention-Deficit/Hyperactivity Disorder (ADHD) is the most commonly diagnosed neurobehavioral disorder in childhood. Children with ADHD struggle in school due to problems with attention and high levels of impulsivity and hyperactivity.

NCT04421248 · Official ClinicalTrials.gov record · Donald Gilbert, MD, MS, FAAN, FAAP

This study wants to assess long term safety in participants who have completed a Novartis trial with secukinumab, have been judged by the investigator to benefit from continued treatment with secukinumab, and are unable to obtain the marketed secukinumab formulation.

NCT04638647 · Official ClinicalTrials.gov record · Novartis Pharmaceuticals

The goal is to assess the safety and effectiveness of home ocrelizumab infusion.

NCT04650321 · Official ClinicalTrials.gov record · University of Colorado, Denver

Single center, randomly assigned, dummy treatment (placebo)- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or dummy treatment (placebo).

NCT04743791 · Official ClinicalTrials.gov record · Sally E. Wenzel MD

This study will measure the how well it works and safety of SPN-812 (viloxazine extended release) in children 4 to 5 years of age with ADHD.

NCT04781140 · Official ClinicalTrials.gov record · Supernus Pharmaceuticals, Inc.

This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment

NCT04877522 · Official ClinicalTrials.gov record · Novartis Pharmaceuticals

With this prospective, randomly assigned, multicentre, parallel group pragmatic non-inferiority trial, the investigators will evaluate if endoscopy-driven introduction of biological therapy is not leading to more postoperative endoscopic recurrence at week 86 compared to systematic prophylactic biological therapy in patients with CD undergoing an ileocolonic resection with ileocolonic anastomosis. Secondary analyses will include influence on clinical, biological and surgical CD recurrence, serious side effects, direct costs, work productivity, and quality of life.

NCT05169593 · Official ClinicalTrials.gov record · Universitaire Ziekenhuizen KU Leuven

This study wants to collect long-term follow-up data on delayed side effects after administration of ciltacabtagene autoleucel (cilta-cel), and to characterize and understand the long-term safety profile of cilta-cel.

NCT05201781 · Official ClinicalTrials.gov record · Janssen Research & Development, LLC

The investigators propose to improve the possibility of reaching skin resolution by identifying certain markers or gene patterns that may predict patient response to certain psoriasis drugs ahead of time, thus eliminating or reducing the trial-and-error approach often employed. The ability to rule out (or in) specific therapeutics based on predictive how well it works would lead to a more personalized approach for psoriasis treatment.

NCT05270733 · Official ClinicalTrials.gov record · University Hospitals Cleveland Medical Center

The study will consist of a 24-week-long trial examining outcomes in patients with Major Depressive Disorder and suicidal ideation who will receive intravenous (IV) ketamine and intranasal (IN) esketamine, compared to a large sample of matched historical controls. Patients will be recruited from an inpatient psychiatric unit.

NCT05450432 · Official ClinicalTrials.gov record · Massachusetts General Hospital

This randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, non-inferiority crossover study will measure the Herpes Zoster Sunbit (HZ/su) vaccine in SLE patients in order to evaluate safety and immunogenicity in patients with variable baseline clinical activities, ages and immunosuppressant exposures. The investigators hypothesize that HZ/su administration will be non-inferior to dummy treatment (placebo) with respect to the risk of moderate or severe SLE flare(s) occurring within 24 weeks of receiving the first dose of the assigned treatment.

NCT05559671 · Official ClinicalTrials.gov record · NYU Langone Health

This study wants to conduct a multicenter, randomly assigned clinical trial to measure the effect of "ShengXian-QuYu Decoction" on quality of life , symptoms, and biomarkers in heart failure patients with reduced and mildly reduced ejection fraction.

NCT05583773 · Official ClinicalTrials.gov record · China-Japan Friendship Hospital

Endometriosis, a chronic gynecological disorder associated with pain and infertility, is a common condition affecting approximately one in ten women. Up to 50% of patients with endometriosis have ovarian endometriomas (or "chocolate cysts").

NCT05837624 · Official ClinicalTrials.gov record · Andrew Zakhari

This study examines the effect of IL4RA blockade with dupilumab on the immune cells of atopic dermatitis skin lesions.

NCT05858619 · Official ClinicalTrials.gov record · University of California, San Francisco

The goal is to study the effect of lithium compared to cariprazine in patients with depression in a bipolar disease. The main question it aims to answer is: Difference in change between the two groups from baseline to after 8 weeks treatment on Hamilton Ratings Scale for Depression, 6-item version (HDS-6) you would be randomly assigned to treatment with either lithium or cariprazin.

NCT05913947 · Official ClinicalTrials.gov record · Aalborg University Hospital

This study is a pragmatic clinical trial examining the comparative effectiveness of two stimulant medications (methylphenidate and amphetamine) in the treatment of ADHD in children and adolescents with autism. Using a sequential, multiple assignment randomization trial (SMART) design the study will not only assess these two medications but also the role of an increasingly popular class of ADHD medication, the alpha-2 agonists.

NCT05916339 · Official ClinicalTrials.gov record · Daniel Coury

There are currently three classes of biologic treatments approved in Canada for the management of moderate-to-severe Crohn's disease: anti-tumor necrosis factor \[TNF\] alpha, anti-integrin, and anti-interleukin \[IL\]-23 targeted agents. The purpose of this trial is to determine which of these three classes of biologics results in the highest percentage of patients with small bowel (ileal) Crohn's disease entering into endoscopic remission without needing corticosteroids at 1 year.

NCT05928039 · Official ClinicalTrials.gov record · University of Calgary

This study will address whether the additional use of Ferric Derisomaltose on top of standard care will improve exercise capacity and quality of life in patients with acute heart failure and iron deficiency. One group of participants will receive treatment with Ferric Derisomaltose and the other group will receive normal saline 0.9% as dummy treatment (placebo).

NCT05971732 · Official ClinicalTrials.gov record · China-Japan Friendship Hospital

This study will address whether the additional use of Ferric Derisomaltose on top of standard care will improve exercise capacity and quality of life in patients with acute heart failure and iron deficiency. One group of participants will receive treatment with Ferric Derisomaltose and the other group will receive normal saline 0.9% as dummy treatment (placebo).

NCT05991128 · Official ClinicalTrials.gov record · China-Japan Friendship Hospital

This study is an treatment, explorative, prospective study to show whether shortening of infusion times for patients using nivolumab, pembrolizumab, ipilimumab, trastuzumab, bevacizumab, durvalumab or atezolizumab continues to be associated with an acceptable safety profile. Infusion times will be gradually shortened if tolerability allowes.

NCT06031233 · Official ClinicalTrials.gov record · Isala

More than 50% of patients with type 2 diabetes develop micro- and/or macrovascular complications during the course of the disease. Additionally, many patients at risk for diabetes develop metabolically driven complications including kidney and heart disease.

NCT06054035 · Official ClinicalTrials.gov record · University Hospital Tuebingen

The goal of this naturalistic, open label, single arm intervention study is to investigate the effects of Esketamine in treating depression.The main aims to answer are: * to see if Esketamine is effective when added to ongoing antidepressant treatment * to identify patient characteristics that will determine a therapeutic response to Esketamine in real-world practice Participants will: * attend the clinic for supervised self-administration of intranasal Esketamine treatment * be observed for 2 hours following Esketamine administration including blood pressure monitoring * be asked to complete a battery of questionnaires * be reimbursed for travel expenses

NCT06103760 · Official ClinicalTrials.gov record · Royal North Shore Hospital

Primary Objective: To study podocyte specific injury markers in African American Veterans with non-diabetic kidney disease (NDKD), on empagliflozin therapy. Primary Endpoint: We will assess the effect of Empagliflozin on podocyte-specific proteins in exosomes isolated from subjects' urine, such as nephrin, podocalyxin and Wilms'Tumor (WT-1) protein.

NCT06110130 · Official ClinicalTrials.gov record · Washington D.C. Veterans Affairs Medical Center

Glucagon-like peptide 1 (GLP-1) is a hormone that helps regulate blood glucose levels through improved insulin sensitivity and release of insulin from the pancreas, control hunger, induce satiety and plays a role in the metabolic health of a person. GLP-1 receptor agonists (GLP1-RAs) have been shown to be effective in achieving weight loss in patients with type 2 diabetes while improving blood glucose control.

NCT06132477 · Official ClinicalTrials.gov record · University of Missouri-Columbia

A substantial fraction of IBD patients with an initial response to infliximab or adalimumab later experience re-emerging active disease despite ongoing anti-Tumour Necrosis Factor (TNF) agents maintenance therapy. The optimal intervention in patients with secondary loss-of-response (LOR) is still poorly defined, as there are still scant data on how best to choose the next intervention from among dose-intensification, switch to another anti-TNF or switch out of the anti-TNF class.

NCT06180382 · Official ClinicalTrials.gov record · Centre Hospitalier Universitaire de Saint Etienne

In patients with ESRD, up to 20% of patients suffer from HFrEF, leading to significant CV morbidity and mortality. Several drug classes that provide survival benefits for patients with HFrEF, including SGLT2i, lack data regarding their how well it works and safety in patients under chronic hemodialysis.

NCT06249932 · Official ClinicalTrials.gov record · National Taiwan University Hospital

The goal of this study is to compare the effectiveness of two formulations of ketamine - Spravato® and racemic ketamine - in people with treatment-resistant depression (TRD). The main questions it aims to answer are: * How the two formulations compare in terms of their effectiveness in treating TRD.

NCT06278779 · Official ClinicalTrials.gov record · The George Institute

This is a prospective multicenter randomly assigned controlled trial with a total duration of 36 months aiming to measure the effectiveness and the safety of low protein diet on top of sodium-glucose cotransporter 2 inhibitors (SGLT2i) and renin-angiotensin-aldosterone inhibitors (RAASi) in reducing the progression of chronic kidney disease in patients with type 2 Diabetes Mellitus

NCT06281899 · Official ClinicalTrials.gov record · Anemia Working Group Romania

The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for side effects. The primary objectives of this study are as follows: * To provide continued access to the study drug received in the parent protocol or switch to bictegravir/emtricitabine/tenofovir (B/F/TAF) for participants who completed a Gilead parent study evaluating drugs for HIV treatment.

NCT06337032 · Official ClinicalTrials.gov record · Gilead Sciences

This study will address whether intravenous (IV) iron repletion with a more intensive target will provide greater benefits in improving exercise capacity for patients with chronic heart failure and iron deficiency. One group of participants will receive a high-dose IV iron regimen with a more intensive target, and the other group will receive a low-dose IV iron regimen with a less intensive target.

NCT06427343 · Official ClinicalTrials.gov record · China-Japan Friendship Hospital

A multi-center pilot study to evaluate safety and how well it works of ozanimod as de-escalation therapy in clinically stable MS patients previously treated with anti-CD20 therapy.

NCT06529406 · Official ClinicalTrials.gov record · University of Colorado, Denver

This study aims to measure the effects of therapy with implantable Gestrinone compared to oral Dienogest in relieving complaints related to endometriosis.

NCT06543550 · Official ClinicalTrials.gov record · Bio Meds Pharmaceutica Ltda

The objective of this trial is to examine the effect of immediate versus late administration of beta blockers, angiotensin converting enzyme inhibitors (ACEI), and sodium/glucose cotransporter 2 (SGLT2) inhibitors on echocardiographic parameters and biomarkers in subjects with ST-elevation myocardial infarction (STEMI)

NCT06562582 · Official ClinicalTrials.gov record · Vastra Gotaland Region

Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain. The main aim of this study is to check for how many participants with UC and CD signs and symptoms disappear after 3.5 months (14 weeks) of treatment with Vedolizumab (this is called remission).

NCT06581328 · Official ClinicalTrials.gov record · Takeda

The aim of this clinical trial is investigate the comparative effectiveness of empagliflozin and dapagliflozin for the treatment of diabetes, chronic kidney disease, and heart failure. Patients who are prescribed either empagliflozin or dapagliflozin, as part of daily clinical practice at the participating sites, will be included in the study.

NCT06642272 · Official ClinicalTrials.gov record · Herlev and Gentofte Hospital

This research is being conducted to see if using an injectable contraception, Depot Medroxyprogesterone Acetate (Depo-Provera), can reduce the pain experienced by women with sickle cell disease. Participants in this study will be adult women with sickle cell disease who regularly experience sickle cell pain.

NCT06665997 · Official ClinicalTrials.gov record · University of Pennsylvania

Repaired Tetralogy of Fallot (rTOF) is the leading cause of congenital cyanotic heart disease worldwide, involving up to 7-10% of congenital heart disease. With advances in open-heart surgical repair techniques and medical therapies, there is a significant increase in patients with rTOF surviving till late adulthood.

NCT06668389 · Official ClinicalTrials.gov record · The University of Hong Kong

Adults with severe asthma may have sudden worsening shortness of breath that results in their going to Emergency Department for urgent care. Emergency Room visits for asthma management across Alberta have been reviewed and it has been found that adults frequently need to return for repeated worsening.

NCT06705764 · Official ClinicalTrials.gov record · University of Alberta

The goal of this clinical trial is to assess the how well it works, safety and durability of faricimab in caucasian patients with polypoidal choroidal vasculopathy (PCV). The main question it aims to answer is: To measure the how well it works of intravitreal (IVT) injections of faricimab 6 milligrams (mg) on Best Corrected Visual Acuity (BCVA) outcomes in caucasian patients with symptomatic macular PCV.

NCT06709339 · Official ClinicalTrials.gov record · Association for Innovation and Biomedical Research on Light and Image