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NCT ID: NCT03608670 Completed - Tachycardia Clinical Trials

Extravascular ICD Pilot Study

EV ICD
Start date: July 17, 2018
Phase: N/A
Study type: Interventional

The proposed study is designed to characterize the safety and efficacy of a new extravascular implantable cardioverter defibrillator (ICD) system in humans.

NCT ID: NCT03605485 Completed - Clinical trials for Obstructive Sleep Apnea

The Evaluation of a Novel Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea

Start date: August 7, 2018
Phase: N/A
Study type: Interventional

This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F&P trial nasal pillows mask amongst Obstructive Sleep Apnea (OSA) participants.

NCT ID: NCT03602560 Completed - Clinical trials for Primary Biliary Cholangitis

ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Start date: October 1, 2018
Phase: Phase 3
Study type: Interventional

A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) The participants might enter the ongoing open-label safety study (NCT03301506) following this double-blind study.

NCT ID: NCT03595553 Completed - Clinical trials for Clostridioides Difficile Infection

Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection

Ri-CoDIFy 1
Start date: January 28, 2019
Phase: Phase 3
Study type: Interventional

Summit is developing ridinilazole as a novel antimicrobial for Clostridioides difficile Infection (CDI), formerly known as Clostridium difficile Infection, with the goal of demonstrating an improved Sustained Clinical Response rate in subjects treated with ridinilazole as compared to subjects treated with vancomycin. A phase 2 proof of concept study, with vancomycin as comparator, demonstrated these attributes with a comparable safety profile. A high fecal concentration of ridinilazole and little systemic exposure were noted. The rationale for this phase 3 study is to confirm the improvement in sustained clinical response of CDI over vancomycin and to compare the safety and tolerability of ridinilazole to that of vancomycin. Ridinilazole plasma concentration will be assessed in a subset of patients.

NCT ID: NCT03593239 Completed - Nicotine Dependence Clinical Trials

Comparing the Pharmacokinetics of Nicotine Salt Based ENDS in Healthy Smokers

Start date: June 29, 2018
Phase: N/A
Study type: Interventional

A Ten Sequence, Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of JUUL 1.7% and JUUL 5% Nicotine Salt Based ENDS Products, in Healthy Adult Smokers.

NCT ID: NCT03577171 Completed - Chronic Hepatitis B Clinical Trials

A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV)

Start date: June 19, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) entecavir (ETV) is safe and effective in participants with chronic hepatitis B infection (cHBV)

NCT ID: NCT03576066 Completed - Chronic Hepatitis B Clinical Trials

A Study Evaluating ABI-H0731 as Adjunctive Therapy in Participants With Chronic Hepatitis B Infection

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

The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) hepatitis B virus (HBV) nucleos(t)ide reverse transcriptase inhibitor (NUC) medication is safe and effective in participants with chronic hepatitis B virus infection (cHBV).

NCT ID: NCT03553056 Completed - Alcohol Consumption Clinical Trials

Feasibility of a Smart-phone Based Support System for Hazardous Drinkers

NZStepAway
Start date: April 30, 2018
Phase: N/A
Study type: Interventional

A feasibility trial to determine whether six months access to the New Zealand 'Step Away' app can reduce the frequency of alcohol abuse and increase engagement with substance abuse-related health services by hazardous drinkers

NCT ID: NCT03553043 Completed - Drinking, Alcohol Clinical Trials

Energy Labelling for Alcohol Drinks in New Zealand: Consumers Perceptions and Impacts on Purchase Behaviour

Start date: May 14, 2018
Phase: N/A
Study type: Interventional

A two-stage qualitative and quantitative study to provide insight into consumers' awareness of energy in alcoholic beverages, and how energy labelling effects consumer behaviour.

NCT ID: NCT03547167 Completed - Clinical trials for Pneumococcal Infections

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults at Increased Risk for Pneumococcal Disease (V114-017/PNEU-DAY)

Start date: July 16, 2018
Phase: Phase 3
Study type: Interventional

This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults at increased risk for pneumococcal disease and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 6 months after receipt of either V114 or Prevnar 13™. Increased risk for pneumococcal disease is defined as 1) an underlying medical condition, 2) behavioral habits such as smoking or alcohol use, or 3) living in a community/environment with increased risk of disease transmission.