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NCT ID: NCT03763812 Not yet recruiting - Clinical trials for Abdominal Aortic Aneurysm

Post Implant Syndrome After EVAR and EVAS (INSPIRE Study)

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

Retrospective data have shown that active sac management, as applied in EVAS, reduces the incidence of the post-implant syndrome. All-cause and cardiac mortality at one-year seems to be lower after EVAS when compared to EVAR. Ongoing, low grade, inflammation could differ between techniques and induce cardiac damage. This study is designed to establish whether EVAS results in a reduced post-operative inflammatory response during the first year after surgery, compared to EVAR as assessed by trends in circulating inflammatory cytokine concentration. Study design: International prospective, comparative, explorative study. Study population: Patients scheduled to undergo infra-renal EVAR with a polyester endograft or EVAS for an infrarenal aortic aneurysm. This is an explorative study and therefore only patients who would normally receive a suitable device as part of standard treatment at the participating institutes will be recruited. Blood samples will be taken at specified time points before and after surgery. Main study parameters/endpoints: The difference in early post-operative and long term inflammatory response between EVAS and EVAR, measured by the incidence of the post-implant syndrome. To investigate the incidence of the post-implant syndrome, the rise in CRP, WBC and circulating cytokines, at specified time points up to 12 months after surgery and the change in aortic thrombus volume and its relationship with the inflammatory response, measured by cytokines' concentrations.

NCT ID: NCT03757338 Completed - Healthy Volunteers Clinical Trials

Bioequivalence Study of a Test Capsule Formulation of Fingolimod With the Reference Capsule Formulation of Fingolimod

Start date: October 23, 2015
Phase: Phase 1
Study type: Interventional

The study evaluates the bioequivalence of the Test formulation, 0.5 mg Fingolimod HCl capsule (Asofarma S.A.I. y C. on behalf of Tolmar, Batch No. 22264), relative to that of the Reference formulation, 0.5 mg Gilenya® (fingolimod) capsule (Novartis Pharmaceuticals, Batch No. S0099), following oral administration of a single oral dose of 3 x 0.5 mg in healthy, adult, male and female subjects under fasting conditions.

NCT ID: NCT03752580 Completed - Clinical trials for Obstructive Sleep Apnea

An Investigation to Test a Prototype Nasal Mask in the Home Setting

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

This investigation is a prospective non-blinded and non-randomized clinical investigation. This investigation is to trial a prototype nasal mask on participants and receive feedback from those participants specifically regarding the usability and reliability of the mask during use over multiple nights. The clinical investigation will be conducted in New Zealand and participants will trial the mask in their home for a period of up to three months. A minimum of 10 participants will participate in this trial.

NCT ID: NCT03747510 Not yet recruiting - Clinical trials for Carpal Tunnel Syndrome

PAVmed CarpX Device Clinical Study

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

To study the safety and feasibility of the CarpX device to divide and release the transverse carpal ligament in order to provide relief for Carpal Tunnel Syndrome (CTS).

NCT ID: NCT03735121 Not yet recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study to Investigate the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Subcutaneous in Patients With Stage IV Non-Small Cell Lung Cancer

Start date: December 28, 2018
Phase: Phase 1
Study type: Interventional

This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab subcutaneous (SC) in patients with Non-Small Cell Lung Cancer (NSCLC). A dose-finding part (Part 1) will aim to identify the dose of atezolizumab SC that yields drug exposure that is comparable to that of atezolizumab IV. A dose-confirmation part (Part 2) will aim to demonstrate the non inferiority of observed drug exposure following treatment with atezolizumab SC at the identified dose compared with historical drug exposure following treatment with atezolizumab IV.

NCT ID: NCT03725839 Recruiting - Clinical trials for Obstructive Sleep Apnea

The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)

Start date: November 5, 2018
Phase: N/A
Study type: Interventional

This investigation is designed to evaluate the performance as well as the patients overall acceptance of the interface.

NCT ID: NCT03725202 Not yet recruiting - Clinical trials for Giant Cell Arteritis (GCA)

A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis

Start date: December 12, 2018
Phase: Phase 3
Study type: Interventional

This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper regimen, as measured by the proportion of participants in sustained remission at Week 52, and to assess the safety and tolerability of upadacitinib in participants with giant cell arteritis (GCA). The objective of period 2 is to evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved remission in Period 1.

NCT ID: NCT03714152 Recruiting - Chronic Hepatitis B Clinical Trials

A Study of ABI-H2158 in Healthy Volunteers and Patients With Chronic Hepatitis B

Start date: November 13, 2018
Phase: Phase 1
Study type: Interventional

This three-part, Phase 1 protocol will be the first clinical study of ABI-H2158. Parts 1 and 2 will be a Phase 1a, dose-ranging assessment of ABI-H2158 in healthy adult volunteers. If the dose-related safety, tolerability, and pharmacokinetics (PK) of ABI-H2158 in healthy volunteers are deemed satisfactory, then the study will advance to Part 3, a Phase 1b, dose-ranging assessment of ABI-H2158 in non-cirrhotic, CHB patients.

NCT ID: NCT03712787 Not yet recruiting - Alzheimer's Disease Clinical Trials

An Extension Study of ABBV-8E12 in Early Alzheimer's Disease (AD)

Start date: November 29, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in subjects with early Alzheimer's Disease (AD).

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