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NCT ID: NCT03088943 Completed - Clinical trials for Echocardiography, Transesophageal

Intraoperative Diastolic Function by TDI and STE

Start date: February 14, 2017
Phase: N/A
Study type: Interventional

This project aims at exploring measures of diastolic function perioperatively.

NCT ID: NCT03088813 Completed - Clinical trials for Small Cell Lung Cancer

Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer

RESILIENT
Start date: April 25, 2018
Phase: Phase 3
Study type: Interventional

A randomized, open label phase 3 study of irinotecan liposome injection (ONIVYDE®) versus topotecan in patients with small cell lung cancer who have progressed on or after platinum-based first-line therapy The study was conducted in two parts: 1. Dose determination of irinotecan liposome injection 2. A randomized, efficacy study of irinotecan liposome injection versus topotecan

NCT ID: NCT03088644 Completed - Healthy Clinical Trials

A Study to Investigate P2X7 Receptor Occupancy by JNJ-54175446 With the Newly Developed P2X7 Receptor Positron Emission Tomography (PET) Tracer 18F-JNJ-64413739

Start date: March 24, 2017
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to measure the whole body distribution and radiation dosimetry of 18F-JNJ-64413739 (Part A), to measure the uptake, distribution, and clearance (CL) of 18F-JNJ-64413739 in the brain of healthy male subjects by Positron Emission Tomography (PET) and to model tissue specific kinetics of 18F-JNJ-64413739 with the appropriate input function (IF) (Part B), to measure subject test retest variability in the distribution of 18F-JNJ-64413739 in the brain of healthy male subjects by comparing PET scans obtained at least 1 week apart (Part C) and following single oral dose administration of JNJ-54175446, to measure the blocking of 18F-JNJ-64413739 uptake in the brain at the time to reach maximum plasma concentration (tmax) of JNJ-54175446 and model the exposure/receptor interaction of JNJ-54175446 in healthy male subjects (Part D).

NCT ID: NCT03086343 Completed - Clinical trials for Rheumatoid Arthritis (RA)

A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs

Start date: May 9, 2017
Phase: Phase 3
Study type: Interventional

The study objective of Period 1 was to compare the safety and efficacy of upadacitinib 15 mg once daily (QD) to abatacept on a background of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in biologic disease-modifying antirheumatic drug (bDMARD)-inadequate response or bDMARD-intolerant participants with moderately to severely active RA. The study objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD in participants with RA who had completed Period 1.

NCT ID: NCT03085810 Completed - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)

Start date: March 24, 2017
Phase: Phase 3
Study type: Interventional

This is a prospective, multicenter, open-label, single-arm, phase 3b study which evaluates effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will consist of an open-label treatment period of 192 weeks and follow-up period of at least 48 weeks. The optional shorter infusion substudy will evaluate the safety of a shorter infusion of ocrelizumab in a subgroup of participants with early stage RRMS enrolled in the main MA30143 study. Approximately 700 patients will be enrolled in the substudy, and will receive additional 600 mg ocrelizumab administered in a shorter time frame.

NCT ID: NCT03085758 Completed - Septic Shock Clinical Trials

Treatment of Patients With Early Septic Shock and Bio-Adrenomedullin(ADM) Concentration > 70 pg/ml With ADRECIZUMAB

AdrenOSS-2
Start date: December 12, 2017
Phase: Phase 2
Study type: Interventional

This is a double-blind, placebo-controlled, randomized, multicenter proof of concept and dose-finding phase II study using two doses of ADRECIZUMAB in patients with early septic shock and a bio-ADM plasma concentration at admission of > 70 pg/ml.

NCT ID: NCT03085134 Completed - Clinical trials for Cow's Milk Protein Allergy

Clinical Safety & Efficacy of a New Infant Formula With Specific Medical Purpose Containing Human Milk Oligosaccharides

CINNAMON
Start date: February 22, 2017
Phase: N/A
Study type: Interventional

The primary objective of the study is to show that infants with cow milk protein allergy (CMPA) fed with a new FSMP infant formula with reduced level of protein & with 2 Human Milk Oligosaccharides (HMOs) (test formula) have a growth in line with infants fed with a comparable FSMP formula but without HMOs (control formula). The secondary objectives are to assess whether consumption of Test formula by CMPA infants (i) reduces medication use and risk for infections in particular lower respiratory tract infections/morbidity, (ii) is well tolerated and allows for age appropriate growth and (iii) reduces health care costs.

NCT ID: NCT03085095 Completed - Prostate Cancer Clinical Trials

A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer

HERO
Start date: April 18, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of relugolix 120 milligrams (mg) orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (< 50 nanograms/deciliter [ng/dL]) in participants with androgen-sensitive advanced prostate cancer.

NCT ID: NCT03083301 Completed - Clinical trials for Cardiac Insufficiency

Cardiac Resynchronization Therapy: Relevance of the Surgical Approach in the Implantation of the Left Ventricular Probe

Start date: April 1, 2017
Phase:
Study type: Observational

Heart failure is very common and reaches more than 56 million people worldwide. 17 to 45 percent die in the first year of hospitalization. The most affected populations live in Western countries like Europe or the USA. It is defined by a set of signs and symptoms such as dyspnea, asthenia, edema or tachycardia but must be objectified, preferably by ultrasound. Its basic treatment is based on a lifestyle improvement and a reduction of the risk factors (hypertension, dyslipidemia, diabetes, ...), as well as an optimal medical treatment based on ACE inhibitors, B-blockers, ARA2 (Sartans), spironolactone or digoxin. When the optimal treatment is no longer working and that the cardiac desynchronization is demonstrated, be it atrio-ventricular, inter-ventricular or intra-ventricular, the patient can benefit from a three-probes cardiac resynchronization to resynchronize the two ventricles. The classic approach, performed by a cardiologist, is to perform an endovenous procedure in order to place the 3 probes under local anesthesia.The first one goes in the right atrium, the second one in the right ventricle and the third one goes in the left ventricle. It is the placement of this third one that often causes trouble. It is more difficult to place since it must pass through the coronary sinus, outside of the heart, unlike the first two probes that are placed endocavitary. When the practitioner fails to place the probe correctly or obtains inappropriate levels of detection, stimulation, or impedance thresholds, a cardiac surgeon must intervene and carry out a mini-thoracotomy. The CHU Brugmann Hospital is in favor of a mixed surgical approach. The probes are placed by a cardiac surgeon, who first starts by a endo-venous placement under local anesthesia. If that approach fails, the local anesthesia can be transformed into general anesthesia at the same operative time and a mini-thoracotomy is performed. The aim of this study is to evaluate the immediate impact of this surgical management within the CHU Brugmann hospital, in patients suffering from cardiac insufficiency despite proper medication.The hypothesis is that the mixed surgical approach improves the prognosis of cardiac resynchronization.

NCT ID: NCT03082521 Completed - Infectious Disease Clinical Trials

Better Antibiotic Prescribing Through Action Research

BAbAR
Start date: April 1, 2017
Phase:
Study type: Observational [Patient Registry]

This PAR (participatory action research) study to improve antibiotic prescribing quality in a GPC (general practitioner cooperative) during OOH-care (out-of-hours-care) uses a mixed methods approach using qualitative as well as quantitative techniques. In a first exploratory phase we will work on partnership development and mapping the existing issues. In a second phase the focus will be on facilitating change and implementing interventions through PDSA (plan do study act) cycles. In a third phase outcomes on prescribing quality during and outside office hours will be evaluated. Equally important is the process evaluation and theory building on improving antibiotic prescribing through PAR.