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NCT ID: NCT03700112 Not yet recruiting - Nicotine Dependence Clinical Trials

Clinical Study Comparing 7 ENDS Products and 1 Combustible Cigarette Using 2 Delivery Methods.

Start date: November 21, 2018
Phase: N/A
Study type: Interventional

A Randomized Study Comparing Nicotine Pharmacokinetics of Seven Electronic Cigarette Products and One Traditional Cigarette Across Two Delivery (10 puff and ad- libitum) Conditions, in Healthy Adult Smokers

NCT ID: NCT03693495 Not yet recruiting - Clinical trials for Group A Streptococcal Infection

Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Participants With Acute Pharyngitis

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

Participants who meet the eligibility criteria and who consent to participation or whose parents/legal guardian consent to their participation, will be enrolled in the study for a period of up to 14 days. Enrolment visit (Day 1) assessments for all participants will include the collection of throat swabs, testing by staff at the site using the ellume·lab Group A Strep Test and testing for Group A Streptococcus by a central laboratory using bacterial culture and polymerase chain reaction (PCR). All participants will be followed up with a phone assessment of adverse events between Days 2-14.

NCT ID: NCT03684044 Not yet recruiting - Influenza Clinical Trials

Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza

Start date: October 17, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, and pharmacokinetics of baloxavir marboxil in combination with a standard-of-care (SOC) neuraminidase inhibitor (NAI) (i.e., oseltamivir, zanamivir, or peramivir) compared with a matching placebo in combination with a SOC NAI in hospitalized patients with influenza.

NCT ID: NCT03672188 Not yet recruiting - Chronic Hepatitis B Clinical Trials

Study of VIR-2218 in Healthy Volunteers and Patients With Chronic Hepatitis B

Start date: October 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase 1/2 study in which healthy volunteers and subjects with chronic HBV infection will receive VIR-2218 or placebo and will be assessed for safety, tolerability, pharmacokinetics, and antiviral activity (only in subjects with chronic HBV).

NCT ID: NCT03656718 Recruiting - Neoplasms by Site Clinical Trials

A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)

Start date: September 24, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to investigate the effects of nivolumab when given under the skin with or without rHuPH20. This study will include participants with 1 of the following advanced or metastatic tumors approved for treatment with nivolumab monotherapy: - non-small cell lung cancer (NSCLC) - renal cell carcinoma (RCC) - unresectable or metastatic melanoma - hepatocellular carcinoma (HCC) - microsatellite instability-high or mismatch repair deficient colorectal cancer (MSI-H/dMMR CRC)

NCT ID: NCT03655613 Recruiting - Clinical trials for Hepatocellular Carcinoma

CBT-501 or Nivolumab in Combination With CBT-101 in Locally Advanced or Metastatic HCC and RCC

Start date: September 5, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Study Design and Investigational Plan: This is an open-label Phase 1/2 study to assess the safety and tolerability of combination PD-1 inhibitor (CBT-501 or nivolumab) administered concomitantly with c-Met inhibitor (CBT-101), to determine the recommended Phase 2 dose of the combination, and to obtain preliminary efficacy in HCC or RCC subjects with advanced or metastatic disease that have not been previously treated with a PD 1 inhibitor or a c-Met inhibitor. HCC subjects will receive the combination CBT-501 plus CBT-101 while RCC subjects will receive the combination nivolumab plus CBT-101. In Phase 1, mandatory archival or fresh tumor biopsies will be collected. In Phase 2, a mandatory fresh tumor biopsy will be required for study entry and another fresh biopsy will be collected between Cycles 2 and 4. The frequency of administration of PD-1 inhibitors will be every 2 weeks starting in Cycle 1 on Day 8 and Day 22 of a 35-day cycle with all subsequent cycles on Day 1 and Day 15 of 28-day cycles. CBT 101 will be administered orally every 12 hours continuously on an empty stomach.

NCT ID: NCT03654326 Recruiting - Clinical trials for Endometriosis-related Pain

A Study to Evaluate the Efficacy and Safety of Gefapixant (MK-7264) in Women With Endometriosis-Related Pain (MK-7264-034)

Start date: September 11, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, and tolerability of gefapixant (MK-7264) in premenopausal female participants with moderate to severe endometriosis-related pain. The primary hypothesis: gefapixant is superior to placebo in reducing the average daily pelvic pain score (cyclic and non-cyclic) during Treatment Cycle 2.

NCT ID: NCT03634020 Not yet recruiting - Clinical trials for Coronary Artery Disease

DynamX Sirolimus StudySirolimus Eluting Coronary Bioadaptor System

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

To confirm the safety and performance of the DynamX Sirolimus-eluting Coronary Bioadaptor System (SECBS) in de novo native coronary artery lesions using clinical and imaging endpoints. Clinical follow-up will be conducted in all patients at 30 days, 6 and 12 months. Imaging follow-up will be conducted at 6 months.

NCT ID: NCT03622021 Not yet recruiting - Psoriasis Clinical Trials

A Study of AK111 in Healthy Subjects

Start date: August 15, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase 1, randomized, double-blind, placebo-controlled, single dose-escalation first-in human study to evaluate the safety, tolerability, PK, PD and immunogenicity of AK111 in healthy subjects following SC administration. The study will consist of cohorts of healthy subjects. Cohort 1, four unique subjects will be randomized to receive either active AK111 (N=3) or matching placebo (N=1). Cohorts 2, 3, 4 and 5, eight unique subjects will be randomized to receive either active AK111 (N=6) or matching placebo (N=2). Approximately 36 subjects will be treated in this study.

NCT ID: NCT03611751 Recruiting - Psoriasis Clinical Trials

An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis

POETYK-PSO-2
Start date: July 11, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the experimental medication BMS-986165 compared to placebo and a currently available treatment in participants with moderate to severe plaque psoriasis.