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NCT ID: NCT03870880 Active, not recruiting - Schizophrenia Clinical Trials

Study to Evaluate the Efficacy and Safety of Risperidone ISM® in Patients With Acute Schizophrenia: Open Label Extension

PRISMA-3_OLE
Start date: August 25, 2017
Phase: Phase 3
Study type: Interventional

This is the long-term open label extension (OLE) of the study PRISMA-3 (NCT03160521). Those patients who complete participation in the main segment of the study (double blind) together with other clinically stable not previously enrolled (de novo patients) may opt to participate in this extension segment, where they will receive active Risperidone ISM® (75 mg or 100 mg)under open-label conditions every four weeks for approximately 12 months.

NCT ID: NCT03869502 Recruiting - Clinical trials for Chronic Myeloid Leukemia in Myeloid Blast Crisis

European CML Blast Crisis Register

BlastCrisis
Start date: October 25, 2018
Phase:
Study type: Observational [Patient Registry]

Multicentric prospective and retrospective register collecting patient with CML blast crisis diagnosed in Germany and Europe

NCT ID: NCT03860428 Recruiting - Clinical trials for Patent Ductus Arteriosus

Early Treatment Versus Expectant Management of PDA in Preterm Infants

Start date: February 15, 2019
Phase: N/A
Study type: Interventional

Patent ductus arteriosus (PDA) in very preterm newborns is associated with severe neonatal mor-bidity: intraventricular hemorrhage (IVH), bronchopulmonary dysplasia (BPD), necrotizing en-terocolitis (NEC), retinopathy of prematurity (ROP). Existing methods of management PDA do not reduce the incidence of these diseases. The efficacy of cyclooxygenase inhibitors (COX) which are currently the standard of treatment in extreme preterm infants is about 70-80%. COX inhibitors have significant side effects. On the other hand, surgical ligation of the ductus arteriosus is associated with deterioration due to cardio-pulmonary problems and long-term complications. Paracetamol has been proposed for treatment of hemodynamically significant PDA because it has a different mecha-nism of action compared with COX inhibitors and a better safety profile. Recently, expectant approach has becoming more popular, although there is not enough evidence to support it. The objective of this study is to investigate whether in preterm infants, born at a GA less than 32 weeks, with a PDA (diameter > 1.5 mm) at a postnatal age of < 72 h, an expectant management is non-inferior to early treatment with regard to the composite of mortality and/or severe morbidity.

NCT ID: NCT03855865 Not yet recruiting - Clinical trials for Depressive Disorder, Major

Study of Rapastinel as Monotherapy in Major Depressive Disorder (MDD)

Start date: April 22, 2019
Phase: Phase 3
Study type: Interventional

The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of Rapastinel, compared to 10 mg of Vortixetine and placebo in participants with major depressive disorder (MDD).

NCT ID: NCT03854305 Recruiting - Crohn's Disease Clinical Trials

Phase 2a Study of PRV-6527 in Subjects With Moderately to Severely Active Crohn's Disease

PRINCE
Start date: March 20, 2018
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of oral PRV-6527 in the treatment of moderately to severely active Crohn's disease

NCT ID: NCT03851705 Recruiting - Renal Impairment Clinical Trials

A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

ORION-5
Start date: February 6, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

This study is a Phase III,A two-part (double-blind placebo-controlled/open-label) multicenter study to evaluate safety, tolerability, and efficacy of inclisiran in subjects with homozygous familial hypercholesterolemia (HoFH).

NCT ID: NCT03849599 Completed - Ulcerative Colitis Clinical Trials

A Study to Evaluate the Safety of PRV-300 in Adult Subjects With Moderately to Severely Active Ulcerative Colitis

PULSE
Start date: February 21, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of PRV-300 for 12 weeks in subjects with active ulcerative colitis. Subjects will receive either PRV-300 or placebo treatment. Each group will receive study drug over a total of 12 weeks, followed by an 8-week safety follow-up period.

NCT ID: NCT03848273 Recruiting - Stroke Clinical Trials

Post Stroke Epileptic Seizures Risk Forecast

POSTER-1
Start date: February 20, 2019
Phase:
Study type: Observational

Improve the effectiveness of treatment and prognosis in patients with cerebrovascular accident by early detection of the risk of developing epileptic seizures.

NCT ID: NCT03824457 Recruiting - Pneumonia Clinical Trials

Efficacy and Safety of Rheosorbilact® Solution for Infusion, in a Complex Therapy of Pneumonia

Start date: January 8, 2018
Phase: Phase 4
Study type: Interventional

This study evaluates the efficacy and safety of Rheosorbilact®, solution for infusion ("Yuria-Pharm" LLC), in comparison with Ringer's Lactate, solution for infusion, in a complex therapy of pneumonia. Half of participants will receive Rheosorbilact® in complex therapy, while the other half will receive Ringer's Lactate in complex therapy.

NCT ID: NCT03814785 Completed - Follicular Lymphoma Clinical Trials

GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)

ASSIST_FL
Start date: December 1, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate comparability of the ORR in patients with previously untreated, advanced stage FL who receive GP2013-treatment to patients who receive MabThera-treatment.