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NCT ID: NCT03985423 Terminated - Clinical trials for Hemophagocytic Lymphohistiocytoses

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Emapalumab in Adult Patients With HLH

Start date: June 2, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Hemophagocytic lymphohistiocytosis (HLH) is a rare, life-threatening condition characterized by uncontrolled hyperinflammation which may develop on the background of several clinical conditions (e.g. autoimmune disease, infection, malignancy). Emapalumab (previously referred to as NI-0501) is a monoclonal antibody neutralizing interferon-gamma (IFN-gamma), a key cytokine driving the inflammation and tissue damage seen in HLH. The purpose of this study is to assess the efficacy, safety and pharmacokinetics of emapalumab in adult patients with secondary HLH.

NCT ID: NCT03984812 Terminated - HIV Infections Clinical Trials

Evaluation of the Safety, Tolerability and Pharmacokinetics (PK) of GSK3732394 First-Time-in-Human (FTIH) Study

Start date: June 17, 2019
Phase: Phase 1
Study type: Interventional

This is a phase 1, 2-part, double-blind (sponsor-unblinded), randomized, placebo-controlled, FTIH study, that includes both single-ascending and multiple-ascending dose phase to assess the safety, tolerability, and pharmacokinetic (PK)/pharmacodynamic (PD) attributes of GSK3732394 in healthy subjects. The data gathered in this study will further enable clinical development of GSK3732394 in HIV-infected subjects. Approximately 72 healthy subjects will be randomized in the FTIH study. Part 1 will be the single ascending dose (SAD) phase and Part 2 will be the multiple ascending dose (MAD) phase. Each subject in the SAD cohort will receive a single dose of blinded GSK3732394 or blinded placebo (PBO) in 6:2 ratio. Part 1 will consist of five ascending single-dose cohorts with an additional expansion cohort included as needed. Part 2 will consist of up to three ascending repeat-dose cohorts (MAD Cohorts 1, 2, and 3), randomized to four weekly doses of blinded GSK3732394 or blinded PBO in 6:2 ratio to be administered on Days 1, 8, 15, and 22.

NCT ID: NCT03984305 Terminated - Parkinson Disease Clinical Trials

Utilization of Target Ranges to Treat Parkinson's Disease With the PKG

TARGET-PD
Start date: October 15, 2019
Phase: N/A
Study type: Interventional

The main objective of this study is to evaluate whether people whose PD symptoms are uncontrolled who are managed with the aid of objective measurement and use of target ranges have improved PD symptoms and outcomes as compared to individuals treated using only standard of care (medical history, neurological examination).

NCT ID: NCT03983941 Terminated - Clinical trials for Anterior Cruciate Ligament Tear

IPACK Versus Popliteal Sciatic Nerve Block in ACL Reconstruction

Start date: August 30, 2019
Phase: Phase 3
Study type: Interventional

This is a prospective study comparing femoral nerve block plus sciatic nerve block to femoral nerve block plus infiltration of the posterior knee capsule (IPACK) in patients undergoing arthroscopic anterior cruciate ligament reconstruction. Femoral nerve block via the adductor canal (FNB-AC) with IPACK may provide effective analgesia while avoiding the motor block involved with sciatic nerve block. The lack of motor block is important to facilitate postoperative ambulation and physical therapy.

NCT ID: NCT03983434 Terminated - Clinical trials for IBS - Irritable Bowel Syndrome

Irritable Bowel Syndrome and Control Volunteers: Diet Challenge

Start date: August 13, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to study the relationship between the bile acids, short chain fatty acids and bacteria within the intestines. The hypothesis is that changes in the bacterial composition of the stool are associated with the differences in bile acids and short chain fatty acids in patients having irritable bowel syndrome compared to healthy individuals.

NCT ID: NCT03983395 Terminated - Breast Cancer Clinical Trials

Study of ISB 1302 (CD3 Bispecific Ab) in HER2-positive Metastatic Breast Cancer

Start date: April 8, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the safety profile, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of single agent ISB1302 in subjects with HER2-positive metastatic breast cancer who have been treated with all known therapies known to confer clinical benefit.

NCT ID: NCT03982342 Terminated - Clinical trials for Patent Ductus Arteriosus

Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants

PIVOTAL
Start date: October 10, 2020
Phase: N/A
Study type: Interventional

This is a pilot study to collect preliminary data for a larger, multicenter clinical trial proposal. The study will examine two strategies commonly used to treat preterm infants diagnosed with a patent ductus arteriosus (PDA). The PDA closes after birth for most term infants, but in many preterm infants, it remains open (patent). A PDA may present a complication for a number of short-term problems faced by preterm infants. Longer-term issues include the development of pulmonary hypertension and changes in the size and performance of the heart. There is ongoing debate as to whether or not the PDA requires intervention.

NCT ID: NCT03982199 Terminated - Clinical trials for Respiratory Tract Diseases

A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV)-Mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older

CYPRESS
Start date: August 1, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to demonstrate the efficacy of active study vaccine in the prevention of reverse transcriptase polymerase chain reaction (RT-PCR) confirmed respiratory syncytial virus (RSV)-mediated lower respiratory tract disease (LRTD), when compared to placebo.

NCT ID: NCT03982017 Terminated - Heart Failure Clinical Trials

Heart Failure Self-care Mobile Application to Reduce Readmissions Trial

HF-SMART
Start date: July 12, 2019
Phase: N/A
Study type: Interventional

This is a patient-centered comparative effectiveness feasibility pilot designed to examine an intervention to increase heart failure self-care and symptom recognition. The investigators will randomize 100 participants to receive either usual care at the time of discharge after heart failure admission or a smartphone application that enhances self-care.

NCT ID: NCT03982004 Terminated - Clinical trials for Metastatic Breast Cancer

Epicutaneous Cryoimmunotherapy Combined With Pembrolizumab for Cutaneous Metastatic Breast Cancer

Start date: September 14, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this research study is to look at the safety and side effects of combining the drug pembrolizumab with imiquimod, GM-CSF, and cryotherapy to treat breast cancer that includes skin lesions.