There are about 3133 clinical studies being (or have been) conducted in Romania. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Cadazolid has demonstrated activity against a bacteria named Clostridium difficile in animal studies. The results of a first study conducted in adult patients have suggested efficacy of the new antibiotic, cadazolid, in the treatment of diarrhea caused by this bacteria. This is the first study of cadazolid in children. The overall purpose of this study is to provide reassurance on the safety and efficacy of cadazolid in children suffering from infection due to Clostridium difficile.
The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).
The study consists of 4 sub-studies, as follows: - Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to intravenous risankizumab induction treatment in Study M16-006 or Study M15-991; - Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991; - Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2, another AbbVie risankizumab Crohn's disease study, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab; - Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab. - OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.
The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.
Interventional, parallel groups, single center trial with a prospective design
This is a 2-part, multicenter, open-label, randomized study of dinutuximab and irinotecan versus irinotecan alone in subjects with relapsed or refractory small cell lung cancer (SCLC). Part 1 of the study involves intrasubject dose escalation to evaluate the safety and tolerability of dinutuximab in combination with irinotecan. Part 2 of the study is designed to determine whether dinutuximab plus irinotecan prolongs overall survival (OS) compared with irinotecan alone. Subjects in Part 2 will be randomized in a 2:2:1 fashion to 1 of 3 treatment groups: (A) irinotecan; (B) dinutuximab plus irinotecan; or (C) topotecan. Randomization will be stratified by duration of response to prior platinum therapy (relapse-free period <3 months or ≥3 months).
With the recent addition of carfilzomib as a treatment option for multiple myeloma, no data is available yet on how the drug is being used outside of the clinical trial setting. This study will therefore provide essential data to demonstrate the real world utilization of carfilzomib in routine clinical practice, including dosage, administration schedule, regimen, duration of treatment and reason for discontinuation in Europe.
A study to evaluate the safety of Nivolumab in participants with advanced or metastatic non-small cell lung cancer
A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with glecaprevir/pibrentasvir compared to the historical SVR12 rates of 12 weeks of treatment with glecaprevir/pibrentasvir.
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