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NCT ID: NCT05645692 Recruiting - Urothelial Cancer Clinical Trials

A Study Evaluating Different Immunotherapies (LAG-3 and PD-1 With or Without TIGIT, Compared to PD-L1 Alone) in Participants With Untreated Locally Advanced Metastatic Urothelial Cancer

Start date: April 13, 2023
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy, safety, and pharmacokinetics of tobemstomig alone or in combination with tiragolumab compared with atezolizumab in participants with previously untreated, locally advanced or metastatic urothelial cancer (mUC) who are ineligible to receive a platinum containing chemotherapy.

NCT ID: NCT05639647 Recruiting - Clinical trials for Gram-negative Bacterial Infections

Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections

Start date: April 18, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate how Aztreonam (ATM) and Avibactam (AVI) are processed in pediatric participants. This study also aims to understand participant safety and effects in pediatric participants. The study is seeking participants who are: - 9 months to less than 18 years of age - Hospitalized - Suspected/known to have a gram-negative infection - Receiving intravenous (iv, given directly into a vein) antibiotics - Being treated for complicated infections of various body parts that includes the abdomen, urinary tract, blood stream, and lungs. - Participants will receive either ATM-AVI or best available therapy (BAT). - Both therapies will be given through a vein. - Participants with complicated abdominal infections will also receive iv Metronidazole (MTZ). - Participants on ATM-AVI treatment who have anaerobic infections will also receive iv MTZ at the study doctor's discretion. - The iv dose of ATM-AVI will be based on the participant's weight and kidney function. - The study doctor will determine the iv dose of BAT. - During the first 2 study days, participants on ATM-AVI therapy will have 5 blood draws in small quantities. - Starting on day 4, the study doctor will decide if participants may be switched to oral therapy. - Participants will receive a maximum of 14 days of ATM-AVI treatment. - After discharge from the hospital, 1 study visit may be required. - Depending on the participant's response, the study duration will be from 33 to 50 days. - The investigator will contact participants by phone 28 to 35 days after the last study treatment to check participants health status.

NCT ID: NCT05639569 Recruiting - Clinical trials for Dissection of Thoracic Aorta

Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study

Start date: May 3, 2023
Phase:
Study type: Observational

The purpose of this study is to collect clinical data on patient outcomes, evaluate the safety and performance of Ankura TAA Stent Graft System and Surpass Super Stiff Guidewire, and build clinical evidence for patients with Descending Thoracic Aneurysm (DTA) or Type B Aortic Dissection (TBAD).

NCT ID: NCT05639439 Recruiting - Airway Management Clinical Trials

Comparative Evaluation of Periglottic Airway Devices With Performed Shape

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate four, most popular periglottic airway devices as regards to ventilation sufficiency and perfection of installation/ anatomical application to the larynx (evaluation with fiberscope).

NCT ID: NCT05636176 Recruiting - Heart Failure Clinical Trials

A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation

HERMES
Start date: May 8, 2023
Phase: Phase 3
Study type: Interventional

This study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get ziltivekimab or placebo. Participants will get study medicine for once-monthly injections either in a pre-filled syringe to inject the study medicine into a skinfold or a pen-injector to inject the study medicine into flat skin. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires.

NCT ID: NCT05629585 Recruiting - Breast Cancer Clinical Trials

A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)

Start date: November 28, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, open-label, 3-arm, multicenter, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with ICT in participants with stage I to III TNBC with residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.

NCT ID: NCT05627583 Recruiting - Anorexia Nervosa Clinical Trials

Nutritional Rehabilitation and Markers of Severity in Anorexia Nervosa

EAT
Start date: September 1, 2022
Phase:
Study type: Observational

The design of this project is a longitudinal trial in patients with Anorexia Nervosa (AN) during in-hospital rehabilitation. Τhe structure of the study, the questionnaires and data protection policy prepared exclusively for our study, have been reviewed and standardised at Institutional Review Boards (Ethics Committees, IRBs,) in Harokopio University of Athens (HUA), Eginition Hospital (EH), Attiko Hospital (AH) and Sismanoglio Hospital (SG). AN is a psychiatric disorder followed by a psychopathologic concerning of body image and very low body weight due to extreme self-starvation. The exact pathogenesis of AN remains unknown with neurobiological, gastrointestinal, neuroendocrinological, immunological, and genetic factors suspected to be implicated. Furthermore, many metabolic traits, biochemical, biological or/and anthropometrical, are manifested during the maintaining effort of patients to achieve lower body weight. Self-inflicted starvation is the primary and essential causation of the pathological outcomes of the disorder. These outcomes involve all biological systems and organs. The role of the immune system in AN is critical as levels of pro-inflammatory cytokines are increased and the immune system is dysregulated. Other contributors to AN pathogenesis have been proposed, such as increased oxidative stress, dysbiosis of the gut microbiota and altered metabolomic profiles. Treatment options for patients with AN constitutes outpatient and inpatient care accordingly with the severity of the disorder. So far, no biomarker has been strongly proposed as an indicator of the disorder's severity or for assessing the progression of the treatment. The purpose of this study is to assess and monitor the nutritional rehabilitation of patients with AN during hospitalization treatment. Throughout the treatment's course, nutrition and feeding process, vital signs, psychopathology and biological samples will be gathered and statistical analysis of these data is expected to reveal potential biomarker/s for monitoring the progression of recovery.

NCT ID: NCT05624450 Recruiting - Clinical trials for Viral Lung Infection and Acute Respiratory Failure

Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen

TILIA
Start date: December 13, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of tozorakimab, as an add-on to SoC in patients with viral lung infection requiring supplemental oxygen, on the prevention of death or progression to IMV/ECMO.

NCT ID: NCT05623020 Recruiting - Multiple Myeloma Clinical Trials

A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135), Daratumumab, and Lenalidomide Compared With Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant

MagnetisMM-6
Start date: November 10, 2022
Phase: Phase 3
Study type: Interventional

Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity. The main purpose of the study is to evaluate if the combination of Elranatamab, Daratumumab and Lenalidomide offers superior clinical benefit compared with the combination of Daratumumab, Lenalidomide and Dexamethasone in people with multiple myeloma. There are 2 parts to this study. Part 1 will characterize the safety and tolerability of elranatamab when administered in combination with daratumumab and lenalidomide and will identify the optimal dose(s) of the combination regimen. Part 2 of the study will evaluate the minimal residual disease (MRD) negativity rate and the progression free survival (PFS) of the combination of elranatamab, daratumumab, and lenalidomide compared with the combination of daratumumab, lenalidomide, and dexamethasone in participants with newly diagnosed transplant-ineligible multiple myeloma.

NCT ID: NCT05620823 Recruiting - Clinical trials for Hidradenitis Suppurativa (HS)

A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa

STOP-HS1
Start date: December 19, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of Povorcitinib (INCB054707) in participants with moderate to severe Hidradenitis Suppurativa (HS) over a 12-week placebo controlled period, followed by a 42-week extension period.