About 767,478 results

Natural History and Development of Spondyloarthritis

Mar 27th, 2023 - The purpose of this protocol is to study the natural history of spondyloarthritis (SpA) in children and adults. Spondyloarthritis encompasses a spectrum of immune-mediated inflammatory diseases that exhibit overlapping features, but differ from other types of inflammatory arthritis in genetic predisposition, pathogenesis, and outcome. Ankylosing spondylitis (AS), the most common form of SpA, fr...

GW572016 With Docetaxel and Trastuzumab for the Treatment Of Untreated ErbB2 Over-Expressing Metastatic Breast Cancer

Mar 31st, 2023 - Phase II part was cancelled before it started. Participants were only enrolled in the phase I part and NOT the phase II part.

A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Subjects With Active Axial Spondyloarthritis Including Ankylosing Spondylitis and Nonradiographic Axial Spondyl...

Mar 31st, 2023 - The purpose of the study is to demonstrate the long-term safety, tolerability and efficacy of bimekizumab in patients with active axial spondyloarthritis (axSpA, also known as radiographic axSpa (r-axSpA)) including ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpa).

Copanlisib With Rituximab-Bendamustine in Patients With Relapsed-Refractory Diffuse Large B-cell Lymphoma

Mar 31st, 2023 - The primary objective of this study is to evaluate the efficacy, in terms of Progression Free Survival (12m-PFS) at 12 months, of a treatment with copanlisib in combination with a standard rituximab-bendamustine regimen in patients with relapsed-refractory DLBCL, who have received at least one, but no more than three lines of treatment, including rituximab-based immunochemotherapy, not eligible...

Predicting the Quality of Response to Specific Treatments in Patients With cGVHD, PQRST Study

Mar 31st, 2023 - OUTLINE: Patients complete questionnaires over 10 minutes about physical symptoms, activity level, and emotional well-being and have their medical records reviewed at baseline, 1, 3, and 6 months after starting index treatment, and at start of a new systemic treatment. Patients also undergo collection of blood samples over 1-2 minutes at baseline and at 1 month after starting index treatment, o...

Multicenter Orthopaedic Outcomes Network (MOON) ACL Reconstruction (ACLR): 10 Year Onsite Follow-up

Mar 31st, 2023 - The purpose of this study is to identify risk factors for signs and symptoms of osteoarthritis two and ten year post ACL reconstruction from information available at the time of surgery. Hypothesis: Smoking status, older age, higher BMI, increased severity of cartilage injuries, increased meniscal resection, revision surgery, and incidence of additional arthroscopic procedures will result in mo...

Ketones, Muscle Metabolism, and SGLT2 Inhibitors - Protocol 1

Mar 31st, 2023 - Purpose/Objectives The EMPA-REG OUTCOME (NCT01131676) trial demonstrated that SGLT2 (sodium-glucose co-transporter) inhibition with empagliflozin markedly reduced cardiovascular (CV) mortality and hospitalization for heart failure. In diabetic patients treated with SGLT2 inhibitors, a rise in plasma ketone concentration consistently has been observed. This has led to the "ketone hypothesis" in ...

Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer

Mar 31st, 2023 - PRIMARY OBJECTIVES: I. To select the better docetaxel-based experimental arm to improve disease-free survival (DFS) over the control arm of radiation and cisplatin. (Phase II) (COMPLETE AS OF 20-MAR-2020) II. To determine if the combination of docetaxel-cetuximab and intensity-modulated radiation therapy (IMRT) is superior in terms of overall survival (OS) compared to standard cisplatin and IMR...

Prevalence of Subclinical Atrial Fibrillation in Heart Failure Patients and Its Relationship With Hospital Readmission

Mar 31st, 2023 - In patients discharged from hospital after an admission for acute heart failure (HF) decompensation, subclinical atrial fibrillation (AF) of 30 minutes or greater in duration is common (at least 15% of patients without prior AF) and is associated with increased risk of re-hospitalization within 30-days. Study Objectives: To evaluate the prevalence of subclinical AF ≥30 minutes in duration in pa...

Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer

Mar 31st, 2023 - This open label (all participants know the identity of the study drug), multicenter (more than one study site), first-in-human study consists of 2 parts. Part 1 is a Amivantamab Monotherapy and Combination Dose Escalations and Part 2 Amivantamab Monotherapy and Combination Dose Expansions. In Part 1, participants with evaluable NSCLC will be enrolled into cohorts at increasing dose levels of Am...

A Study of ARRY-371797 (PF-07265803) in Patients With Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation

Mar 31st, 2023 - This is a randomized, double-blind, placebo-controlled study in patients with dilated cardiomyopathy (DCM) due to a mutation of the gene encoding the lamin A/C protein (LMNA). The study will further evaluate a dose level of study drug (ARRY-371797) that has shown preliminary efficacy and safety in this patient population. After the primary analysis has been performed, eligible patients may rece...

First Line Therapy of Advanced Stage Follicular Lymphoma in Patients < 60 Years Not Eligible fo Standard Immunochemotherapy and in All Patients ≥ 60 Years

Mar 31st, 2023 - Study design: This is a randomized, open-label, multicenter phase II trial with a parallel-group design of two groups. Randomization and Interventions: Randomization between Obinutuzumab single agent treatment versus Obinutuzumab plus Bendamustine followed by Obinutuzumab Treatment plans: Arm A: Obinutuzumab single agent Obinutuzumab flat dose of 1000 mg on Day 1 of each of four 28 -day cycles ...

Biliary Atresia Study in Infants and Children

Mar 31st, 2023 - Little is known about the factors that cause biliary atresia nor the factors that influence disease progression. A variety of genetic, autoimmune and environmental influences have been hypothesized to be important. Most studies to date have focused on the neonate and young child with BA, yet the older surviving child with BA can provide important information about genetics, as well as, natural ...

A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

Mar 31st, 2023 - This is a multicenter study in pediatric participants aged 2 to 17 years with moderately to severely active UC, defined as a baseline Mayo score of 6 through 12, inclusive, with an endoscopy subscore of greater than or equal to (>=)2. This 54-week study will consist of a 6-week short-term phase and a 48-week long-term phase followed by a study extension (Week 54 to end of study). At Week 58, pa...

Enhancing Ultrasound & Photoacoustic for Recognition of Intestinal Abnormalities

Mar 31st, 2023 - The clinical investigation, EUPHORIA, will pave the way to establish Multispectral Optoacoustic Tomography (MSOT) technology for the non-invasive assessment of intestinal inflammation in patients. EUPHORIA will enable commercialization of the technology by finalizing technical improvements that will increase diagnostic outcome beyond what has been shown in a first feasibility study, will improv...

Valiant Evo US Clinical Trial

Mar 31st, 2023 - Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 total subjects, in order to obtain 87 evaluable subjects for the primary endpoint. The two protocols are identical, and the trials were run simultaneously to enroll subjects concurrently in the United States (US) and Outside United States (OUS). The...

Glans Size in Hypospadias Compared to Normal

Mar 31st, 2023 - After obtaining informed consent , the investigator will measure stretched penile length and glans size in 3 dimensions (length, width, height) in the office on patients with hypospadias, as well as at the time of operation, after the induction of anesthesia. Patients undergoing hypospadias surgery will be considered study subjects. If the patient was given pre-operative testosterone as part of...

Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC

Mar 31st, 2023 - The primary objective of this study is to evaluate the efficacy of cabozantinib (XL184) in combination with atezolizumab versus a second NHT (abiraterone or enzalutamide) in subjects with mCRPC who have previously been treated with one, and only one, NHT (e.g. abiraterone, apalutamide, darolutamide, or enzalutamide) to treat metastatic castration-sensitive prostate cancer (mCSPC), non-metastati...

COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction

Mar 31st, 2023 - This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.

Phase 1 Study of SAR440894 vs Placebo

Mar 31st, 2023 - A single, ascending-dose design with five dose-cohorts of 8 subjects. Forty healthy adults aged 18 to 45, inclusive, will be recruited and admitted at one US site. Each subject will be randomized to receive either SAR440894 or matching placebo via 60-minute intravenous infusion. In each cohort of 8 subjects, the randomization ratio will be 6 active to 2 placebo, and 2 sentinel subjects (one fro...