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NCT ID: NCT03411031 Terminated - Multiple Myeloma Clinical Trials

Elotuzumab Plus Lenalidomide (Elo/Rev) for Serologic Relapse/Progression While on Lenalidomide

Start date: October 4, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is determine Time-to-Progression with elotuzumab plus lenalidomide when elotuzumab is added to multiple myeloma participants with serologic relapse/progression while receiving lenalidomide maintenance for each study arm.

NCT ID: NCT03410927 Terminated - Clinical trials for Advanced Solid Tumors With HER3 Abnormalities

A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities

Start date: April 6, 2018
Phase: Phase 1
Study type: Interventional

This is a First-in-Human (FIH), 2-part, Phase 1/2, open-label, multicenter study design to evaluate the safety, tolerability, PK, pharmacodynamics, PGx, and efficacy of TAS0728. This study consists of Phase 1 and Phase 2 components in subjects with advanced solid tumors with HER2 or HER3 overexpression, amplification, or mutation who have progressed despite standard therapy or for which no standard therapy exists, particularly urothelial cancer, biliary tract cancer, metastatic breast cancer, non-small cell lung cancer and colorectal cancer.

NCT ID: NCT03410056 Terminated - Clinical trials for Rheumatoid Arthritis RA

Safety and Efficacy of Efavaleukin Alfa in Subjects With Active Rheumatoid Arthritis

Start date: May 22, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Phase 1b. To evaluate the safety and tolerability of subcutaneous (SC) dose administrations of Efavaleukin alfa in subjects with active rheumatoid arthritis (RA). Phase 2a. To evaluate the efficacy of Efavaleukin alfa at week 12 as measured by the American College of Rheumatology 20 percent improvement criteria (ACR 20) in adult subjects with moderate to severe RA.

NCT ID: NCT03409679 Terminated - Pneumonia Clinical Trials

Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa

PRISM-MDR
Start date: March 23, 2018
Phase: Phase 3
Study type: Interventional

This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability, and pharmacokinetics of intravenous murepavadin combined with of one anti-pseudononas antibiotic with that of two anti-pseudomonas antibiotics in the treatment of ventilator-associated bacterial pneumonia (VABP) in adult subjects.

NCT ID: NCT03409601 Terminated - Feeding Behavior Clinical Trials

The Role of Satiety in the Effect of Portion Size on Intake

Start date: April 2, 2018
Phase: N/A
Study type: Interventional

The study uses a crossover design in which the portion size of food is varied at each meal. Across four test meals, subjects will be served four different portions of food, and intake will be determined from pre- and post-meal food weights. The first visit will be a screening visit, at which subjects will complete the consent form, have their height and weight measured, and rate the taste of the study food. Test meals will be scheduled once a week for four weeks. At visits 2-5, subjects will eat lunch and rate characteristics of the meal. At visit 6, subjects will complete various questionnaires. The objective of this study is to determine whether any individual characteristics related to satiety influence the effect of portion size on intake.

NCT ID: NCT03409289 Terminated - Cardiac Arrest Clinical Trials

RHAPSody: Diagnostic Utility of RUSH Following ROSC

Start date: May 1, 2018
Phase:
Study type: Observational

This will be a prospective observational study of adult primary cardiac arrest patients presenting to Shands Emergency Department following ROSC or actively in cardiac arrest with subsequent ROSC after treatment in the emergency department.

NCT ID: NCT03407976 Terminated - Clinical trials for Urothelial Carcinoma

Apatinib With Pembrolizumab in Previously Treated Advanced Malignancies

APPEASE
Start date: June 19, 2018
Phase: Phase 1
Study type: Interventional

This is an open label nonrandomized Phase I/ IIA trial designed to assess the safety, tolerability, and efficacy of apatinib in combination with pembrolizumab. Phase I will assess the safety of combining increasing oral daily doses of apatinib with a fixed dose of IV pembrolizumab every three weeks and will determine the RP2D (Recommended Phase 2 Dose). Phase II will assess the efficacy of the RP2D of apatinib in combination with pembrolizumab and provide additional safety and tolerability data in three disease-specific cohorts

NCT ID: NCT03407482 Terminated - Clinical trials for Lupus Erythematosus, Systemic

An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

Start date: January 9, 2018
Phase: Phase 2
Study type: Interventional

This Phase II, multicenter, open-label extension (OLE) study will evaluate the long-term safety and efficacy of GDC-0853 in participants with systemic lupus erythematosus (SLE) who have completed Study GA30044 (NCT02908100) up to 48 weeks.

NCT ID: NCT03407430 Terminated - Breast Cancer Clinical Trials

Trial of Pregabalin for Granulocyte Colony-stimulating Factor (GCSF)-Induced Bone Pain

Start date: January 27, 2016
Phase: Phase 2
Study type: Interventional

Purpose: To evaluate the preventative effects of pregabalin on pegfilgrastim-induced bone pain in cycle 1. Because granulocyte colony stimulating factor (G-CSF) receptors are found at nerve endings which modulate the pain signal, blocking this with pregabalin is theorized to prevent the occurrence of this adverse effect. Participants: Patients will be at least 18 years of age with either a diagnosis of a non-myeloid hematologic malignancy scheduled to initiate a cycle of chemotherapy that requires prophylactic use of a G-CSF, or with a diagnosis of breast cancer scheduled to initiate dose-dense doxorubicin/cyclophosphamide chemotherapy or docetaxel/cyclophosphamide that requires prophylactic use of a G-CSF. Procedures (methods): This is a randomized (1:1), single center, placebo-controlled, double blind, crossover phase II study. The primary objective is to compare the proportion of patients who have an increase in pain score of ≥3 from baseline in cycle 1 between Arm A (pregabalin) and Arm B (placebo). In consultation with the treating physician, the PI will determine what day pegfilgrastim will be initiated in each eligible, consented patient. Pregabalin or placebo will begin 4 days prior to pegfilgrastim administration, and continue for 7 additional days starting the day of pegfilgrastim administration.

NCT ID: NCT03407287 Terminated - Atrial Fibrillation Clinical Trials

Peripheral Venous Analysis (PIVA) for Predicting Volume Responsiveness and Fluid Status

PIVA
Start date: January 8, 2018
Phase:
Study type: Observational

The aim of this study is to determine the effects of fluid alternations, hemodynamic changes, mechanical ventilation, pharmacologic agents, positional changes, and comorbidities on the Peripheral Intravenous waveform Analysis (PIVA) signal.