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NCT ID: NCT03474770 Active, not recruiting - Clinical trials for Focal Impaired Awareness Seizures

BIS-001-ER for the Treatment of Adult Focal Impaired Awareness Seizures

FIAS
Start date: April 10, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to examine safety signals and demonstrate seizure reduction in adults with FIAS treated with BIS-001ER as an add-on therapy in an in-patient and out-patient study design.

NCT ID: NCT03474263 Withdrawn - Clinical trials for Amyotrophic Lateral Sclerosis

IC14 for Rapidly Progressive Amyotrophic Lateral Sclerosis (ALS)

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

Patients with rapidly progressive ALS will be assigned to IC14 intravenously on Day 1-4. This 4-day course will be repeated on Days 8-11. Patients will all undergo MR-PET scans at two time points: before treatment onset and after the last treatment cycle. This scan will measure areas of ALS disease activity and assess response to IC14 treatment. MR-PET scans will be compared to historical controls.

NCT ID: NCT03474107 Active, not recruiting - Bladder Cancer Clinical Trials

A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

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

The purpose of this study was to compare the overall survival (OS) of participants with locally advanced or metastatic urothelial cancer treated with enfortumab vedotin (EV) to the OS of participants treated with chemotherapy. This study compared progression-free survival on study therapy (PFS1); the overall response rate (ORR) and the disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 of participants treated with EV to participants treated with chemotherapy. In addition, this study evaluated the duration of response (DOR) per RECIST V1.1 of EV and chemotherapy and assessed the safety and tolerability of EV, as well as, the quality of life (QOL) and Patient Reported Outcomes (PRO) parameters.

NCT ID: NCT03474029 Recruiting - Latent Tuberculosis Clinical Trials

Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI

ASTERoiD
Start date: August 1, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

This study is conducted to compare the safety and effectiveness of a novel short 6-week regimen of daily rifapentine (6wP, experimental arm) with a comparator arm of 12-16 weeks of rifamycin-based treatment (standard of care, control arm) of latent M. tuberculosis infection (LTBI). This trial is conducted among persons who are at increased risk of progression to tuberculosis (TB) and require treatment of LTBI. The study will be conducted in low, medium and high TB incidence settings that have treatment of LTBI as their standard of care and offer 12-16 week rifamycin-based therapy as standard of care. The hypothesis of this study is that the safety and effectiveness of the experimental treatment (6wP arm) is non-inferior to a comparator arm of 12-16 weeks of rifamycin-based treatment of LTBI (control arm). Participants are enrolled and randomly assigned to one of the two study arms: experimental 6wP or control. The comparator (control) arm's treatment regimens include 12 weeks of once-weekly isoniazid (INH) and rifapentine (3HP), 12 weeks of daily INH and rifampin (3HR), and 16 weeks of daily rifampin (4R). A total of 560 participants per arm (1,120 total) for the evaluation of safety and 1,700 participants per arm (3,400 total) for the evaluation of effectiveness will be enrolled, given treatment as per randomization assignment, and followed for 24 months from the date of enrollment. After completion of data collection, statistical analyses will be conducted to compare proportions of drug discontinuation due to adverse drug reaction (ADR) and proportions of newly diagnosed tuberculosis between 6wP and control arm.

NCT ID: NCT03473925 Completed - Clinical trials for Non-small Cell Lung Cancer

Efficacy and Safety Study of Navarixin (MK-7123) in Combination With Pembrolizumab (MK-3475) in Adults With Selected Advanced/Metastatic Solid Tumors (MK-7123-034)

Start date: April 10, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of navarixin (MK-7123) in combination with pembrolizumab (MK-3475) in adults with one of three types of solid tumors: Programmed Death-Ligand 1 (PD-L1) positive refractory non-small cell lung cancer (NSCLC), castration resistant prostate cancer (CRPC) or microsatellite stable (MSS) colorectal cancer (CRC).

NCT ID: NCT03473223 Completed - Clinical trials for Acute Coronary Syndrome

Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome

AEGIS-II
Start date: March 21, 2018
Phase: Phase 3
Study type: Interventional

This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events [MACE - cardiovascular (CV) death, myocardial infarction (MI), and stroke] in subjects with acute coronary syndrome (ACS) diagnosed with either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI), including those managed with percutaneous coronary intervention (PCI) or medically managed.

NCT ID: NCT03472040 Completed - Clinical trials for Hereditary Angioedema

A Long Term Safety Study of BCX7353 in Hereditary Angioedema

APeX-S
Start date: February 16, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This is an open-label study to evaluate the long term safety and effectiveness of oral treatment with BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II Hereditary Angioedema (HAE).

NCT ID: NCT03471793 Recruiting - Colon Polyp Clinical Trials

The Australian Colonic Large Sessile Lesion Endoscopic Resection Study

ACE
Start date: February 24, 2017
Phase:
Study type: Observational

A prospective, multicentre, observational study of all patients referred for endoscopic resection of sessile colorectal polyps sized ≥20 mm conducted with intention to treat analysis

NCT ID: NCT03471403 Recruiting - Clinical trials for Familial Adenomatous Polyposis

Cold Snare Polypectomy for Duodenal Adenomas in Familial Adenomatous Polyposis

COPDA
Start date: October 10, 2017
Phase:
Study type: Observational

The purpose of this study is to collect prospective observational data regarding patients with diagnosed Familial Adenomatous Polyposis (FAP) undergoing cold snare polypectomy for duodenal adenomas

NCT ID: NCT03471247 Active, not recruiting - Respiratory Failure Clinical Trials

CYCLE: A Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients

CYCLE
Start date: October 15, 2018
Phase: N/A
Study type: Interventional

Patients who survive critical illness usually experience long-lasting physical and psychological impairments, which are often debilitating. Rehabilitation interventions started in the ICU may reduce this morbidity. In-bed cycling, which uses a special bicycle that attaches to the hospital bed, allows critically ill patients who are mechanically ventilated (MV) to gently exercise their legs while in the ICU. The main goal of this study is to determine whether critically ill MV adults recover faster if they receive early in-bed cycling than if they do not. Another objective is to determine whether in-bed cycling is a cost-effective intervention. 360 patients admitted to the ICU and receiving MV will be enrolled in the study. Following informed consent, patients will be randomized to either (1) early in-bed cycling and routine physiotherapy or (2) routine physiotherapy alone. Patients' strength and physical function will be measured throughout the study. If early in-bed cycling during critical illness improves short-term physical and functional outcomes, it could accelerate recovery and reduce long-term disability in ICU survivors.