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NCT ID: NCT03347396 Completed - Clinical trials for Agglutinin Disease, Cold

A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study)

Start date: March 5, 2018
Phase: Phase 3
Study type: Interventional

The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (>=) 2 grams per deciliter (g/dL) increase in hemoglobin (Hgb) levels or increased Hgb to >= 12 g/dL and obviated the need for blood transfusion during treatment in participants with primary cold agglutinin disease (CAD) who had a recent history of blood transfusion. The purpose of Part B was to evaluate the long-term safety and tolerability of sutimlimab in participants with CAD.

NCT ID: NCT03347383 Completed - Clinical trials for Peripheral Arterial Disease

Clinical Trial Investigating the Combination Therapy With Luminor DCB and iVolution Stent in TASC C and D Femoropopliteal Lesions

TINTIN
Start date: September 19, 2017
Phase: N/A
Study type: Interventional

The T.I.N.T.I.N. study investigates the safety and efficacy of the combination therapy with the Luminor drug coated balloon (DCB) and the iVolution stent in the treatment of TASC C and D femoropopliteal lesions. An expected total of 100 patients will be treated in the scope of this study. The lesion is located within the native superficial femoral artery and/or the popliteal artery. Prior to dilatation with the Luminor DCB, pre-dilatation with the Oceanus balloon is mandatory. After dilatation with the Luminor DCB, stenting with the iVolution stent need to be performed. Post-dilatation can be performed according to the physician's discretion. Patients will be invited for a follow-up visit at 1, 6, 12, 24, 36, 48 and 60 month post-procedure. The primary efficacy endpoint of the study is defined as the freedom from clinically-driven target lesion revascularization (TLR) at 12 months. Secondary endpoints include primary patency rate at 6 and 12 months, freedom from clinically-driven TLR at 6, 24, 36, 48 and 60 months, clinical success at 1, 6, 12, 24, 36, 48 and 60 months and freedom from serious adverse events at pre-discharge, 1, 6, 12, 24, 36, 48 and 60 months follow-up.

NCT ID: NCT03346512 Completed - Cardiac Surgery Clinical Trials

Considerations on the Transfusion Threshold in Cardiac Surgery

Start date: February 2016
Phase:
Study type: Observational

This is a retrospective observational study of the transfusion threshold in cardiac surgery. There is controversy in the literature regarding the transfusion threshold to be adopted, especially in a patient who has undergone cardiac surgery. Some authors suggest that the transfusion should be done in a restrictive way when a certain threshold in hemoglobin is reached, in order to avoid the risks it implies, especially infectious.This threshold is very controversial and remains to be defined (variations in the literature from 7g / dL to 9g / dL). Other authors conclude that there is no superiority of a restrictive transfusion compared to a more liberal transfusion, with regard to the morbidity or medical costs. It is therefore interesting to study, in a retrospective manner, the global and multidisciplinary management of patients who have undergone a cardiac surgery within the CHU Brugmann hospital, to analyze if they have been adequately transfused.

NCT ID: NCT03346174 Completed - Clinical trials for Gastro-oesophageal Reflux

Influence of Airway Clearance Techniques on GOR in Infants

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether Assisted Autogenic Drainage (AAD) or bouncing combined with Assisted Autogenic Drainage (BAAD), induces or aggravates acid and non-acid gastro-oesophageal reflux in infants under the age of one year. Infants, referred to the hospital for impedance-pH monitoring are included in this study.

NCT ID: NCT03346122 Completed - Healthy Clinical Trials

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-64991524 in Healthy Participants

Start date: November 15, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate safety and tolerability of JNJ-64991524 compared with placebo after administration of single ascending oral doses of JNJ-64991524 (Part 1) and multiple ascending oral doses of JNJ-64991524 (Part 2) in healthy participants.

NCT ID: NCT03346070 Completed - Clinical trials for Neuromuscular Blockade

Efficacy and Safety of Sugammadex Dosed According to Actual Body Weight (ABW) or Ideal Body Weight (IBW) in Reversal of Neuromuscular Blockade (NMB) in Morbidly Obese Participants (MK-8616-146)

Start date: January 1, 2018
Phase: Phase 4
Study type: Interventional

The purpose of this trial is to evaluate the safety and efficacy of Sugammadex when administered according to actual body weight (ABW) as compared to ideal body weight (IBW) for the reversal of both moderate and deep neuromuscular blockade (NMB) induced by either Rocuronium or Vecuronium in morbidly obese participants. The primary hypothesis of this investigation is that, compared to obese participants dosed based on IBW, obese participants receiving Sugammadex according to ABW will demonstrate a faster time to recovery to a Train Of Four (TOF) ratio of ≥0.9 (i.e. faster NMB reversal), pooled across NMB depth and type of neuromuscular blocking agent (NMBA; Rocuronium or Vecuronium) administered.

NCT ID: NCT03345992 Completed - Sepsis Clinical Trials

Benefit of Clarithromycin in Patients With Severe Infections Through Modulation of the Immune System

INCLASS
Start date: December 15, 2017
Phase: Phase 3
Study type: Interventional

High mortality associated with sepsis and Multiple Organ Dysfunction Syndrome (MODS) calls for alternative, individualized therapies in selected patients that might benefit form specific interventions. Role of macrolides as potential immunomodulatory treatment in sepsis is promising, but unclear. Subgroup analysis of previous large-scale clinical trials on patients with ventilator-associated pneumonia or gram-negative sepsis, showed that addition of clarithromycin to standard antibiotic therapy conferred a significant survival benefit in the subgroup of patients with respiratory dysfunction and MODS. The INCLASS study is aiming to assess the efficacy of intravenous treatment of clarithromycin in the reduction of 28-day mortality among patients suffering from these entities.

NCT ID: NCT03345849 Completed - Crohn's Disease Clinical Trials

A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies

U-EXCEL
Start date: December 7, 2017
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in adults with moderately and severely active Crohn's disease (CD).

NCT ID: NCT03345836 Completed - Crohn's Disease Clinical Trials

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

Start date: November 29, 2017
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).

NCT ID: NCT03345095 Completed - Clinical trials for Newly Diagnosed Glioblastoma

A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma

MIRAGE
Start date: July 26, 2018
Phase: Phase 3
Study type: Interventional

The standard of care for newly diagnosed glioblastoma includes surgery, involved-field radiotherapy, and concomitant and six cycles of maintenance temozolomide chemotherapy, however the prognosis remains dismal. Marizomib has been tested in patients with newly diagnosed and recurrent glioblastoma in phase I and phase II studies. In patients with recurrent glioblastoma, marizomib was administered as a single agent or in combination with bevacizumab (NCT02330562). Based on encouraging observations, a phase I/II trial of marizomib in combination with Temozolomide+Radiotherapy(TMZ/RT) followed by Temozolomide (TMZ) in newly diagnosed glioblastoma has been launched (NCT02903069) which explores safety and tolerability of this triple combination and which shall help to determine the dose for further clinical trials in glioblastoma. In this context, given that marizomib has been established as a safe addition to the standard TMZ/RT -->TMZ, a phase III study is considered essential to establishing its impact on overall survival.