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Displaying 21 - 40 of 1019

Open Actively Recruiting

Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)

This is a double-blind, randomized, placebo-controlled, PoC study to evaluate the efficacy, safety, and tolerability of efzofitimod in patients with SSc-ILD. The primary objective of the study is to evaluate the PoC for efficacy in a population with SSc-ILD. While improvement of ILD is the outcome of interest, the study will also evaluate changes in the skin. After initial screening (up to 4 weeks), approximately 25 eligible participants will be randomized 2:2:1 to 1 of 2 active (experimental) dose arms or placebo, administered every 4 weeks up to and including Week 20.

Phase: Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Tory Ham
Open Actively Recruiting

Hyperbaric Oxygen Therapy for Ulcerative Colitis

Chronic intestinal hypoxia and accompanying mucosal inflammation is a hallmark of ulcerative colitis (UC). Hyperbaric oxygen therapy (HBOT) involves breathing 100% oxygen under increased atmospheric pressure to increase tissue oxygenation. Two small prospective randomized controlled trials have demonstrated that the delivery of HBOT to UC patients hospitalized for acute moderate to severe flares results in improved remission rates and avoidance of in-hospital progression to biologics, small molecules, or colectomy. In this larger trial the study aims to confirm the treatment benefits of HBOT for hospitalized UC patients and study the immune-microbe mechanisms underpinning treatment response.

Phase: N/A
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Xiaoxiao Yin
Investigator: Jenny S. Sauk, MD
Open Actively Recruiting

Study of DISC-0974 to Assess the Safety, Tolerability, PK and PD of DISC-0974 in Participants With CKD and Anemia

This Phase 1b study of DISC-0974 will assess the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamics (PD) of DISC-0974 in adult participants with Non-Dialysis Dependent Chronic Kidney Disease and Anemia.

Phase: Phase 1
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Jessica Gomez
Open Actively Recruiting

A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Children
Open Actively Recruiting

IO-202 as Monotherapy and IO-202 Plus Azacitidine ± Venetoclax in Patients in AML and CMML

To assess safety and tolerability at increasing dose levels of IO-202 in successive cohorts of participants with AML with monocytic differentiation and CMML in order to estimate the maximum tolerated dose (MTD) or maximum administered dose (MAD) and select the recommended Phase 2 dose (RP2D)

Phase: Phase 1
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Bruck Habtemariam
Open Actively Recruiting

Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer

The study is intended to assess the safety and efficacy of perioperative treatment with Durvalumab in combination with Oleclumab, Monalizumab or AZD0171 and platinum doublet chemotherapy (CTX); or Volrustomig in combination with platinum doublet chemotherapy or datopotamab deruxtecan (Dato-DXd) in combination with durvalumab and single agent platinum chemotherapy in participants with resectable, early-stage non-small cell lung cancer.

Phase: Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Dawit Hailu
Investigator: Jay M. Lee, MD

RECOVER-NEURO: Platform Protocol to Measure the Effects of Cognitive Dysfunction Interventions on Long COVID Symptoms

This platform protocol is designed to be flexible so that it is suitable for a wide range of settings within health care systems, for remote settings, and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans.

This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating potential interventions for PASC-mediated cognitive dysfunction. The hypothesis is that PASC associated dysfunction in cognitive domains, such as executive function and attention, may be improved by interventions that selectively focus on enhancing those domains.

Phase: Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Camila Kerwin
Open Actively Recruiting

Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

This screening and multi-sub-study Phase 1b/2 trial will establish a method for genomic screening followed by assigning and accruing simultaneously to a multi-study "Master Protocol (BAML-16-001-M1)." The specific subtype of acute myeloid leukemia will determine which sub-study, within this protocol, a participant will be assigned to evaluate investigational therapies or combinations with the ultimate goal of advancing new targeted therapies for approval. The study also includes a marker negative sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies.

Phase: Phase 1/Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Vladimir Kustanovich
Open Actively Recruiting

Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Immune Modulation Strategy Trial

COVID-19 can trigger a dysregulated immune response, and previous studies have shown that immune modulation can improve outcomes in hospitalized patients. This trial is designed to determine whether intensification of immune modulation early in the course of the disease (while patients are on low flow oxygen) with abatacept (active arm) combined with standard of care (SOC) improves recovery as compared with placebo + SOC (placebo arm). For both groups, intensification of immunomodulation will be provided as part of SOC in case of signs of disease progression (patient requires high flow nasal oxygen (HFNO) or more support) and/or if the patient has rapidly increasing oxygen requirement.

Phase: Phase 4
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Lorenzo Duvergne
Investigator: George W. Lim, MD
Open Actively Recruiting

Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy

This Phase 3, multicenter, double-masked, parallel-group, placebo-controlled, randomized, fixed-dose clinical study is designed to evaluate the efficacy and safety of tinlarebant (LBS-008) in subjects diagnosed with GA.

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Mayra Raygoza
Open Actively Recruiting

Pediatric Patients Aged 1 to 6 Years With APDS

This is a 2-part, prospective, open-label, single arm, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and efficacy of leniolisib in at least 15 pediatric patients (aged 1 to 6 years) with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS)

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Children
Contact: Alexis Stephens

A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma

This phase II/III trial tests the safety, side effects, and best dose of the drug cabozantinib in combination with standard chemotherapy, and to compare the effect of adding cabozantinib to standard chemotherapy alone in treating patients with newly diagnosed osteosarcoma. Cabozantinib is in a class of medications called kinase inhibitors which block protein signals affecting new blood vessel formation and the ability to activate growth signaling pathways. This may help slow the growth of tumor cells. The drugs used in standard chemotherapy for this trial are methotrexate, doxorubicin, and cisplatin (MAP). Methotrexate stops cells from making DNA and may kill tumor cells. It is a type of antimetabolite. Doxorubicin is in a class of medications called anthracyclines. It works by slowing or stopping the growth of tumor cells in the body. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Adding cabozantinib to standard chemotherapy may work better in treating newly diagnosed osteosarcoma.

Phase: Phase 2/Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Adults, Children
Contact: MIKAYLA HENDERSON
Open Actively Recruiting

A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Open Actively Recruiting

Investigating Safety, Tolerability, Efficacy and PK of Olaparib in Paediatric Patients With Solid Tumours

A study to find out whether olaparib is safe and well tolerated when administered to children and adolescents with solid tumours.

Phase: Phase 1
Primary Purpose: Treatment
Gender: All
Age Group: Adults, Children
Contact: Stacy Zamora
Open Actively Recruiting

The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) Patients

To investigate the effect of VTA ablation at the time of LVAD implant to see if it can reduce the incidence of VTA after surgery

Phase: Phase 4
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Julie Sorg
Open Actively Recruiting

CONNEXINS AS POTENTIAL BIOMARKERS AND THERAPEUTIC TARGETS FOR VASCULAR MALFORMATION IN HHT

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Age Group: Adults
Contact: Victoria Rueda
Open Actively Recruiting

Comparison of Two Pulmonary Embolism Treatments

The primary objective of this trial is to evaluate the safety and efficacy of treatment with anticoagulation alone versus anticoagulation and mechanical aspiration thrombectomy with the Indigo Aspiration System for the treatment of intermediate-high risk acute pulmonary embolism (PE).

Phase: N/A
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Open Actively Recruiting

Alzheimer's Disease Neuroimaging Initiative 4

Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) Study has been to validate biomarkers for Alzheimer's disease (AD) clinical trials. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3 studies that have combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of AD.

Phase: N/A
Gender: All
Age Group: Adults
Contact: Lorena Macias
Open Actively Recruiting

A Study to Evaluate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)

A study to assess the safety and efficacy of K-321 in participants with FECD after descemetorhexis.

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Rubi Arias
Open Actively Recruiting

Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age

The primary purpose of this study is to assess the efficacy and safety of daily DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month treatment period.

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Children
Contact: Stacey Skura Zedeck