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NCT ID: NCT03830281 Completed - Clinical trials for Type 1 Diabetes Mellitus

A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy

PRONTO-Pump-2
Start date: February 14, 2019
Phase: Phase 3
Study type: Interventional

The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog) when both are used in insulin pump therapy in adults with type 1 diabetes (T1D).

NCT ID: NCT03829657 Terminated - Clinical trials for Parkinson's Disease (PD)

Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure

REDWOOD
Start date: February 22, 2019
Phase: Phase 3
Study type: Interventional

A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of ampreloxetine in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure

NCT ID: NCT03829332 Completed - Clinical trials for Non-small Cell Lung Cancer

Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer (NSCLC) (MK-7902-007/E7080-G000-314/LEAP-007)

Start date: March 13, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) in treatment-naïve adults with no prior systemic therapy for their metastatic non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%. The primary study hypotheses are that: 1) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); and 2) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Overall Survival (OS).

NCT ID: NCT03829319 Active, not recruiting - Clinical trials for Nonsquamous Non-small Cell Lung Cancer

Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006)

Start date: March 25, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of pemetrexed + platinum chemotherapy + pembrolizumab (MK-3475) with or without lenvatinib (MK-7902/E7080) as first-line intervention in adults with metastatic nonsquamous non-small cell lung cancer. The primary study hypotheses state that: 1) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Progression-free Survival (PFS) as assessed by blinded independent central review (BICR) per modified Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST 1.1) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab, and 2) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Overall Survival (OS) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab.

NCT ID: NCT03823989 Completed - Cancer Clinical Trials

Intravenously Administered Liposomal PROMITIL in Combination With External Beam Radiotherapy in Cancer Patients

Start date: January 3, 2019
Phase: Phase 1
Study type: Interventional

This will be a multi-center, open-label, single-arm, prospective study, in which up to 18 adult patients requiring radiotherapy for metastatic disease or for an inoperable primary tumor with no definitive curative treatment option, will undergo a combination treatment of intravenously (IV) delivered PROMITIL and standard of care radiotherapy. The treatment regimen will involve administration of two PROMITIL doses, delivered at a 21-day interval, and a course of EBR (type of RT according to investigator's preference), initiated 1-3 days after the first PROMITIL dose and completed within a 2-week period. EBR will consist of no more than 10 fractions delivered within 2 weeks as conventionally fractionated RT, or SBRT. Treatment safety will be assessed on a weekly basis throughout the two 21-day treatment courses (42 days) and throughout the follow-up period (up to Day 127). AEs will only be logged until 6 weeks after the last PROMITIL dose (up until Day 64). Disease status will be reevaluated between days 43-50 of the study, and every 6 weeks thereafter (Days 85 and 127±7 days). In addition, following completion of the treatment schedule, all patients will be followed up by phone every 12 weeks, until either death, disease progression (PD), withdrawn consent or trial cut-off date, i.e., for up to 2 years after patient accrual to study, (whichever occurs first). The following anticancer agents will NOT be allowed during the screening period, 6-week treatment period and until first disease reevaluation: cytotoxic agents, non-cytotoxic myelosuppressive agents (CDK 4/6 inibitiors, PARP inhibitors, m-TORS inhibitors and tyrosine kinase-inhibitors). Treatment with hormonal agents, monoclonal antibodies (anti-EGFr, anti-Her2, anti-VEGF and VEGFr, anti-PD1, anti-PDL1) and bisphosphonates can be continued during the study.

NCT ID: NCT03823638 Recruiting - Parkinson Disease Clinical Trials

Safety, Tolerability and Effects of Mannitol in Parkinson's Disease

PD-mannitol
Start date: November 20, 2018
Phase: Phase 2
Study type: Interventional

Parkinson's disease is a progressive neurodegenerative disease that causes disabling motor and cognitive impairments. Currently, no disease-modifying therapy exists for this disease. Mannitol, a naturally-occurring substance, which is commonly used as sweetener, was offered as such agent. In this phase II, safety, tolerability-based dose finding, and efficacy study, mannitol or placebo (dextrose) in escalating doses will be given to patients with Parkinson's disease for 36 weeks.

NCT ID: NCT03823469 Completed - Obesity Clinical Trials

Evaluating the Impact of a Culinary Coaching Tele-medicine Program

Start date: May 20, 2019
Phase: N/A
Study type: Interventional

Introduction: Obesity is a major public health problem and adopting healthy lifestyle habits, while effective, is challenging in real-world settings. Culinary coaching is a behavioral intervention that aims to improve nutrition and overall health by facilitating home cooking through an active learning process that combines culinary training and health coaching. Our goal is to evaluate whether a culinary coaching telemedicine program (twelve 30-minute sessions) will significantly improve outcomes among subjects with overweight or obesity. General hypothesis: A culinary coaching telemedicine program will result in significant weight loss, and improvement in culinary attitude and self-efficacy, nutritional intake, and metabolic outcomes. Methods: This is a two-site, 36-month randomized controlled trial in which study participants between the ages of 25 to 70, with 27.5 ≤ BMI ≤ 35 Kg/m2 will be randomly assigned to nutritional counseling combined with a structured culinary coaching program or to nutritional counseling group (18 intervention, 18 control at each site). Intervention will include a 3-month culinary coaching telemedicine program with outcome data collected periodically for 12 months. The pre-defined primary outcome is body weight loss at 6 months, and secondary outcomes include change in body weight and composition at 1 year, as well as culinary attitudes and self-efficacy through a validated questionnaire, nutritional intake, lipid profile, blood pressure, and HgA1c (glycated hemoglobin); and participants' perception of the program. Potential impact: The investigators believe that this program has a potential to be a viable tool in promoting effective and scalable home cooking interventions aimed at improved nutrition and health outcomes in overweight and obesity.

NCT ID: NCT03823391 Completed - Clinical trials for Rheumatoid Arthritis (RA)

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)

Start date: March 27, 2019
Phase: Phase 2
Study type: Interventional

This study will assess the safety, tolerability, and efficacy of ABBV-3373 in participants with moderately to severely active rheumatoid arthritis (RA) on background methotrexate (MTX) compared with adalimumab.

NCT ID: NCT03823287 Completed - Clinical trials for Wet Macular Degeneration

A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (TENAYA)

Start date: February 19, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).

NCT ID: NCT03822143 Not yet recruiting - Anemia in Fetus Clinical Trials

Fetus Anemia Diagnosis by Ultrasound Data Collection

Start date: February 2019
Phase: N/A
Study type: Interventional

The aim of this study is to diagnose anemia in fetuses through the use of ultrasound.