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NCT ID: NCT03373383 Completed - Clinical trials for Drug-resistant Epilepsy

Study to Test the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adults With Drug-resistant Epilepsy

ARISE
Start date: February 12, 2018
Phase: Phase 2
Study type: Interventional

The purpose of the study is to characterize the dose-response relationship with respect to efficacy of Padsevonil administered concomitantly with up to 3 anti-epileptic drugs (AEDs) for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.

NCT ID: NCT03371251 Completed - Clinical trials for Systemic Lupus Erythematosus

Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care

Start date: January 10, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This study will be conducted to assess the safety, tolerability, and immunogenicity of repeat doses of BOS161721 (20 milligrams [mg], 60 mg, and 120 mg) administered subcutaneously in adult participants with moderately to severely active Systemic Lupus Erythematosus (SLE) on limited background standard of care treatment, in order to estimate the optimal dose. BOS161721 at the chosen dose will be compared to placebo for response on the SLE Responder Index 4, with sustained reduction of oral corticosteroids, in the same participant population.

NCT ID: NCT03371082 Completed - Clinical trials for Diabetes Mellitus, Type 1

Gan & Lee Insulin Glargine Target Type (1) Evaluating Research

GLITTER1
Start date: October 31, 2017
Phase: Phase 3
Study type: Interventional

Primary Objective: •To evaluate equivalence of Gan & Lee Insulin Glargine Injection and Lantus® in terms of immunogenicity Secondary Objective: Immunogenicity: • To evaluate the percentage of subjects with negative anti-insulin antibodies (AIAs) at baseline who develop confirmed positive AIA up to Week 26, the percentage of baseline in AIA titers between treatment groups, the percentage of subjects with confirmed positive AIA who develop any anti-insulin neutralizing antibodies up to visit Week 26, and percentage of subjects who develop confirmed positive AIA up to visit Week 26 of Gan & Lee Insulin Glargine Injection in comparison with that of Lantus®. Safety: •To evaluate the safety of Gan & Lee Insulin Glargine Injection in comparison with that of Lantus®. Efficacy: •To evaluate the efficacy of Gan & Lee Insulin Glargine Injection in comparison with that of Lantus®.

NCT ID: NCT03370133 Completed - Psoriatic Arthritis Clinical Trials

A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

BE VIVID
Start date: December 6, 2017
Phase: Phase 3
Study type: Interventional

This is a study to compare the efficacy of bimekizumab versus placebo and an active comparator in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).

NCT ID: NCT03369665 Completed - Multiple Sclerosis Clinical Trials

Evaluation of Quality of Life (QoL) in Subjects With Highly Active Relapsing Multiple Sclerosis (MS) (CLARIFY MS)

Start date: June 20, 2018
Phase: Phase 4
Study type: Interventional

The main purpose of the study was to assess the health-related quality of life (HRQoL) through the Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) scale in highly-active relapsing multiple sclerosis (RMS) particpants treated with Mavenclad® for 2 years (24 months).

NCT ID: NCT03364465 Completed - Pneumonia Clinical Trials

Lung Protective One-lung Ventilation With Fix and Variable Tidal Volume

Start date: February 1, 2017
Phase: N/A
Study type: Interventional

During One-lung ventilation, the use of lower tidal volumes (VT) is helpful to avoid over-distension, provide sufficient oxygenation, but can result in increased atelectasis. Nevertheless, it is not known if, during one-lung ventilation with constant low VT, moderate levels of PEEP combined with lung recruitment maneuvers are superior to variable low tidal volume for intraoperative oxygenation and protection against PPCs. Aim of the study is to compare a strategy using constant tidal volume with recruitment maneuvers versus variable tidal volume with recruitment maneuvers during thoracic surgery in adults. We hypothesize that in adult, non-obese patients undergoing thoracic surgery under standardized OLV with variable tidal volumes, modearte PEEP and recruitment maneuvers as compared to constant without recruitment maneuvers prevent PPCs. Patients will be randomly assigned to one of two groups: FIX TIDAL VOLUME GROUP (Groupfix): mechanical ventilation with constant (6 ml/kgIBW) tidal volume and PEEP of 5 cmH2O with recruitment maneuvers VARIABLE TIDAL VOLUME GROUP (Groupvar): mechanical ventilation with variable (6 ml/kgIBW ± 33%) tidal volume with variable respiratory rate to maintain constant minute ventilation and PEEP of 5 cmH2O with recruitment maneuvers.

NCT ID: NCT03364036 Completed - Multiple Sclerosis Clinical Trials

Evaluation of the Onset of Action in Highly Active MS (MAGNIFY)

Start date: May 28, 2018
Phase: Phase 4
Study type: Interventional

The main purpose of the study was to determine the onset of Mavenclad® action by frequent magnetic resonance imaging (MRI) assessment of the combined unique active (CUA) lesions in participants with highly active relapsing multiple sclerosis (MS).

NCT ID: NCT03362879 Completed - Clinical trials for Parkinson's Disease (PD)

COmedication Study Assessing Mono- and cOmbination Therapy With Levodopa-carbidopa inteStinal Gel

COSMOS
Start date: December 14, 2017
Phase:
Study type: Observational

The purpose of this study is to evaluate treatment of advanced Parkinson's Disease (PD) patients on levodopa-carbidopa intestinal gel (LCIG) monotherapy in a routine clinical setting.

NCT ID: NCT03362190 Completed - Clinical trials for Wet Age-related Macular Degeneration

ZIMURA in Combination With LUCENTIS in Patients With Neovascular Age Related Macular Degeneration (NVAMD)

Start date: October 11, 2017
Phase: Phase 2
Study type: Interventional

To assess the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Lucentis® 0.5 mg in treatment naïve subjects with neovascular age related macular degeneration (NVAMD)

NCT ID: NCT03358576 Completed - Clinical trials for Intra Abdominal Infections

Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)

Start date: September 18, 2018
Phase: Phase 3
Study type: Interventional

This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin-metronidazole for treatment of complicated intra-abdominal infections in adults.