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NCT ID: NCT03775486 Not yet recruiting - Clinical trials for Non-small Cell Lung Cancer NSCLC

Study of Durvalumab+Olaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer (ORION)

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

This is a randomized, double-blind, multi-center, global Phase II study to determine the efficacy and safety of Durvalumab plus Olaparib combination therapy compared with Durvalumab monotherapy as maintenance therapy in patients whose disease has not progressed following Standard of Care (SoC) platinum-based chemotherapy with Durvalumab as first-line treatment in patients with Stage IV non small-cell lung cancer (NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) fusions.

NCT ID: NCT03774199 Recruiting - Clinical trials for Pulse Oximeter Calibration

NightOwl Pulse Oximeter Calibration Study

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

Calibration of a software module that computes SpO2 based on photoplethysmography (PPG) traces acquired by a reflectance-based pulse oximeter which can be placed on the index finger or the forehead. The study is designed in accordance with Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601- 2-61:2011)

NCT ID: NCT03773133 Not yet recruiting - Clinical trials for Small Cell Lung Cancer and Breast Cancer

Evaluate the Safety, Tolerability, Biodistribution and Anti Tumour Activity of 177LU-OPS201 With Companion Imaging 68Ga-OPS202 PET/CT in Previously Treated Subjects With Locally Advanced or Metastatic Cancers Expressing Somatostatin Receptor 2 (SSTR2)

Start date: January 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This study consists of two phases. The phase I study is designed to investigate the safety and tolerability of Satoreotide tetraxetan following fractionated i.v. administrations in pre-treated subjects with locally advanced or metastatic cancers expressing sstr2 as identified by Satoreotide trizoxetan Positron Emission Tomography (PET/CT) scans. This phase will encompass both radioactivity escalation and peptide mass dose evaluation. Phase II will assess the efficacy of Satoreotide tetraxetan in subjects in selected indications, in a basket design.

NCT ID: NCT03772600 Enrolling by invitation - Clinical trials for Type 1 Diabetes Mellitus

Comparing Continuous With Flash Glucose Monitoring in Adults With Type 1 Diabetes

Start date: January 2019
Phase: N/A
Study type: Interventional

The present study wants to compare the Dexcom G6® continuous glucose monitoring (CGM) system (experimental group) with the FreeStyle Libre flash glucose monitoring (FGM) system (control group). The ALERTT1 trial will have three phases: a baseline, study, and extension phase. During the baseline phase, eligible patients will be screened for in- and exclusion criteria, wear a blinded Dexcom G6® for 28 days, together with their FreeStyle Libre FGM system, and receive a uniform education moment. In the study phase, patients will be randomized into two groups (1:1): the experimental group will use an unblinded Dexcom G6® CGM for 6 months, the control group will keep using the FreeStyle Libre FGM system for 6 months. Before the 6 month time point is reached, patients in the control group will wear a blinded Dexcom G6® CGM for 28 days, together with their FreeStyle Libre FGM. In the extension phase, patients in the initial control group will start using unblinded Dexcom G6® for 12 months. The initial experimental group will keep using the unblinded Dexcom G6® for the next 12 months.

NCT ID: NCT03772444 Recruiting - Postoperative Ileus Clinical Trials

Use of Beetroot Juice to Protect Against Postoperative Ileus (POI) Following Colorectal Surgery: a Pilot Study.

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

The BEET IT study investigates the possible protective effect of beetroot juice on POI following colorectal surgery in (partially) blinded single-center phase 2 randomized trial (pilot study).

NCT ID: NCT03772106 Completed - General Anesthesia Clinical Trials

Effect of Sevoflurane and Propofol on Hepato-splanchnic Pressure and Flow During Hepatobiliary Surgery

Start date: June 8, 2017
Phase: Phase 4
Study type: Interventional

Blood loss in hepatobiliary surgery is correlated with an increase in postoperative complications (e.g. transfusion related lung injury and tumor recurrence) and reduced longterm survival. To reduce morbidity and mortality in hepatobiliary surgery, modulation of the hepato-splanchnic blood flow and pressure is used. In liver surgery pharmacological modulations are widely used to prevent blood loss. For pharmacological modulation central venous pressure is commonly used to reduce the pressure in the inferior vena cava, however little is known about pharmacological effect on blood flow in the hepatic artery and portal vein. The modulation of the hepato-splanchnic blood flow can also play an important role, not only for prevention of blood loss but also for survival of the organs (e.g. ischemic injury due to low flow). Volatile anesthetics induce a dose-dependent reduction of the hepato-splanchninc blood flow. Propofol however, increases hepatic blood flow when compared with volatile anesthetics. Pharmacological modulation of hepato-splanchnic bloodflow with anesthetics such as sevoflurane or propofol can play an important role in modulation of ischemia/reperfusion injury and survival of organs. The aim of the study is to determine and to compare the effect of sevoflurane versus propofol on hepatosplanchnic pressure and hepato-splanchnic blood flow during hepatobiliary surgery.

NCT ID: NCT03771898 Not yet recruiting - Clinical trials for Metachromatic Leukodystrophy (MLD)

A Study of Intrathecal SHP611 in Participants With Late Infantile Metachromatic Leukodystrophy

Start date: April 30, 2019
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to evaluate the effects of intrathecal (IT) administration of SHP611 on gross motor function, using the Gross Motor Function Classification in Metachromatic Leukodystrophy (GMFC-MLD) compared with matched historical control data in children with metachromatic leukodystrophy (MLD).

NCT ID: NCT03771859 Not yet recruiting - Melanoma Clinical Trials

A Study of Patients Receiving Adjuvant Nivolumab Therapy for Melanoma That Has Been Removed

Start date: December 8, 2018
Study type: Observational

A study in melanoma patients with involvement of lymph nodes or disease that has spread who have undergone complete removal and are eligible for added treatment with nivolumab

NCT ID: NCT03768791 Recruiting - Clinical trials for Failed Back Surgery Syndrome

HRV in Patients Treated With Spinal Cord Stimulation

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

This study is an observatory single center study investigating heart rate variability during on and off states of the spinal cord stimulator, in patients with failed back surgery syndrome.

NCT ID: NCT03768609 Not yet recruiting - Healthy Clinical Trials

A Study to Evaluate the Effect of Cyclosporine, a P-Glycoprotein, Breast Cancer Resistance Protein, and Organic-Anion-Transporting Polypeptide Inhibitor, on Pimodivir in Healthy Adults

Start date: December 10, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the effect of a single oral dose of cyclosporine on the pharmacokinetics of a single oral dose of pimodivir when coadministered to healthy adult participants under fasted conditions.