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NCT ID: NCT03739710 Recruiting - Neoplasms Clinical Trials

Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC)

Start date: January 24, 2019
Phase: Phase 2
Study type: Interventional

This study will compare the clinical activity of novel regimens (in combination or as single agents) to SoC in participants with relapsed/refractory advanced NSCLC. The study will be conducted in two parts. Part 1 is an open-label, optional, non-randomized part based on safety and pharmacokinetics/pharmacodynamics (PK/PD) evaluation intended to generate additional data to qualify novel regimens for the randomized study. Part 2 is a randomized, Phase II open-label part comparing the efficacy and safety of these novel regimens with SoC. Drug name mentioned as GSK4428859A (belrestotug) and EOS884448 are interchangeable for the same compound and will be referred to as GSK4428859A/EOS884448/belrestotug.

NCT ID: NCT03739684 Completed - Prostate Cancer Clinical Trials

Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer

CONDOR
Start date: November 27, 2018
Phase: Phase 3
Study type: Interventional

This study evaluates the diagnostic performance and safety of 18F-DCFPyL (PyL) PET/CT imaging in patients with suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging.

NCT ID: NCT03739203 Completed - Clinical trials for Major Depressive Disorder

The Objective of This Study is to Evaluate the Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone

Start date: November 10, 2018
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD who have had an inadequate response to antidepressants alone.

NCT ID: NCT03739112 Completed - Clinical trials for Respiratory Tract Infections

Efficacy of a Plant-derived Quadrivalent Virus-like Particle (VLP) Vaccine in the Elderly

Start date: September 18, 2018
Phase: Phase 3
Study type: Interventional

This Phase 3 study was intended to assess the relative efficacy of the Quadrivalent VLP Influenza Vaccine during the 2018-2019 influenza season compared to a licensed vaccine in elderly adults 65 years of age and older. One dose of VLP Influenza Vaccine (30 μg/strain) or of Comparator (15 μg/strain) was to be administered to 12,738 participants.

NCT ID: NCT03738865 Completed - Clinical trials for Type 1 Diabetes Mellitus

G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes

Start date: September 27, 2018
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, controlled, single-blind, two-way crossover efficacy and safety study in subjects with Type 1 diabetes mellitus. The study involves two daytime clinical research center (CRC) visits with random assignment to receive G-Pen glucagon 1 mg during one period and Novo Glucagon 1 mg during the other. Each daytime visit is preceded by an overnight stay in the CRC. In the morning of the inpatient study visit, the subject is brought into a state of severe hypoglycemia through IV administration of regular insulin diluted in normal saline. After a hypoglycemic state with plasma glucose < 54 mg/dL (3 mmol/L) is verified, the subject is administered a dose of G-Pen or Novo Glucagon via subcutaneous injection. Plasma glucose levels are monitored for up to 180 minutes post-dosing, with a value of >70.0 mg/dL (3.89 mmol/L) or an increase of > 20 mg/dL (>1.11 mmol/L) within 30 minutes of glucagon administration indicating a positive response. After 3 hours, the subject is given a meal and discharged when medically stable. After a wash-out period of 7 to 28 days, subjects return to the CRC, and the procedures are repeated with each subject crossed over to the other treatment. A follow-up visit as a safety check is conducted 2-7 days following administration of the final dose of study drug.

NCT ID: NCT03738800 Terminated - Lamellar Ichthyosis Clinical Trials

A Safety, Efficacy and Systemic Exposure Study of CD5789 Cream in Adults and Adolescents With Lamellar Ichthyosis

Start date: May 1, 2019
Phase: Phase 2
Study type: Interventional

This is a phase 2 randomized, multi-center, double-blind, vehicle controlled, 90 day, safety, efficacy, and systemic exposure study followed by a 90 day open-label extension of trifarotene cream in adults and adolescents with autosomal recessive ichthyosis with lamellar scale.

NCT ID: NCT03738527 Recruiting - Breast Cancer Clinical Trials

SEroma Reduction pOst MAstectomy "SEROMA Study"

SEROMA
Start date: October 7, 2019
Phase: Phase 4
Study type: Interventional

This is a pilot study to evaluate the feasibility of conducting a larger trial to determine if the use of intraoperative topical tranexamic acid (TXA) decreases the rate of post-operative hematomas and seromas in breast cancer patients after their mastectomy. In other words, the investigators want to determine if applying TXA inside the surgical wound before it is closed helps reduce blood or serous fluid accumulation at the operative site. Dependent on the results of this study, a further larger trial may or may not take place. Post-operative seromas and hematomas are common complications of mastectomy surgery not only leading to infection, discomfort, wound dehiscence or emergency room visits; they also delay in some instances post-operative adjuvant radiotherapy. Establishing whether or not topical TXA is an effective strategy to decrease those complications can potentially impact positively the breast cancer treatment. To achieve this aim, this randomized pilot study will first determine whether a larger multicenter study if feasible. This study will replicate a formal randomized trial at a smaller scale in a single center in order to assess the recruitment and randomization process, as well as provide preliminary results for our research question.

NCT ID: NCT03738423 Terminated - Atopic Dermatitis Clinical Trials

Efficacy, Safety, and Pharmacokinetic Profiles of REGN3500 Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

Start date: November 13, 2018
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to assess the efficacy of REGN3500 monotherapy in Atopic dermatitis (AD), as well as understand the dose-response relationship, compared with placebo treatment, in adult patients with moderate-to-severe AD. Secondary objectives are to: - Assess the safety and tolerability of subcutaneous (SC) doses of REGN3500 monotherapy in adult patients with moderate-to-severe AD - Assess the Pharmacokinetics (PK) of REGN3500 in adult patients with moderate-to-severe AD - Assess the immunogenicity of REGN3500 in adult patients with moderate-to-severe AD

NCT ID: NCT03738397 Completed - Atopic Dermatitis Clinical Trials

A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis

Heads Up
Start date: February 21, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate upadacitinib compared to dupilumab (Dupixent®) in adults with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

NCT ID: NCT03738384 Suspended - Arthroplasty Clinical Trials

Knee Connect: Physiotherapy Exercise Performance With Visual Feedback After Total Knee Arthroplasty

Start date: March 9, 2020
Phase: N/A
Study type: Interventional

The main objective of this pilot study is to determine if using a portable, accelerometer based, visual feedback system improves exercise quality. The secondary objective of this study is to investigate the effect of motivational targets by testing the effects of increasing ROM targets. The results from this study will be used to improve the visual feedback system of the Knee Connect system and serve as starting point for a larger clinical study.