Sponsor: SIFI MedTech Italy

Condition: Cataract

Title: Retrospective observational trial on the visual performances of a Progressive Multifocal intraocular lens with extended depth of focus

NCT: 02740010

Study Type: Retrospective trial

Study Design: Retrospective observational trial

IMP: Medical device

No. of clinical sites/countrie(s): 5/Italy

Sponsor: SIFI MedTech Italy

Condition: Cataract

Title: An open label, non-comparative study to assess the visual performances and safety of a progressive multifocal  intraocular lens with extendeddepth of focus

NCT: 02838004

Study Phase: III

Study Type: Interventional

Study Design: open label, non-comparative trial

IMP: Medical device

No. of clinical sites/countrie(s): 1/ Germany, 2/Italy, 2/Romania

Sponsor: Effik Italia SpA

Condition: Recurrent Bacterial Vaginosis

Title: A multicenter, open label, non-comparative, 3 months study to assess the performance and safety of the new medical device Polybactum® in reducing the frequency of Recurrent Bacterial Vaginosis

NCT: 02863536

Study Phase: III

Study Type: Interventional

Study Design: multicenter, open label, non-comparative trial

IMP: Medical device

No. of clinical sites/countrie(s): 3/Italy, 3/Romania

Sponsor: MdM SpA Italy

Condition: Acute low back pain

Title: A phase III, multicenter, randomized, parallel groups study to assess the efficacy and safety of 0,5 mg TIZASPRAY® administred intranasally versus SIRDALUD® 2 mg tablets in patients with acute low back pain

NCT: 02934061

Study Phase: III

Study Type: Interventional

Study Design: multicenter, randomized, parallel groups trial

IMP: Drug

No. of clinical sites/countrie(s): 3/Italy, 5/Romania

Sponsor: MdM SpA Italy

Condition: Dyslipidemia

Title: A pilot, open label, non-comparative study to assess the efficacy and safety of the new Food Supplement FaseMETS® in the management of dyslipidemia

NCT: 02912325

Study Phase: III

Study Type: Interventional

Study Design: Pilot, open label, non-comparative trial

IMP: Food Supplement

No. of clinical sites/countrie(s): 2/Romania

Dr. Adrian Enache  ~ SCM Dr. ROSU, Timisoara (Romania)

Prof. Assoc. Gabriela Doina Negrisanu ~ Centrul Medical Dr. Negrisanu Timisoara (Romania)

Sponsor: MdM SpA Italy

Condition: Acute low back pain

Title: A phase II, multicenter, randomized, parallel groups study to assess the efficacy and safety of two dose levels (0,5 mg and 1 mg) TIZASPRAY administred intranasally versus  SIRDALUD® 4 mg, in patients with acute low back pain

Study Phase: II

Study Type: Interventional

Study Design: multicenter, randomized, parallel groups trial

IMP: Drug

No. of clinical sites/countrie(s): 3/Romania

Sponsor: Ricerfarma, Italy

Condition: Infant teething

Title: A randomized, open, parallel-group multicenter study of efficacy and tolerability of a new medical device in gel formulation (Hyaluronic Acid 0.54%) versus Calgel® (Lidocaine 0.33% and Cetylpyridinium Chloride 0.10%) for the topical treatment of teething in infants

NCT: 02931357

Study Type: Interventional

Study Design: A randomized, open, parallel-group multicenter trial

IMP: Medical device

No. of clinical sites/countrie(s): 2/Romania

 

Sponsor: Iuppa Industriale Italy

Condition: Pediatric functional constipation

Title: An Open label, non-comparative pilot study to assess the efficacy and safety of the Food Supplement Physiomanna® Baby in pediatric patients with a history of functional constipation

NCT: 02732743

Study Phase: IV

Study Type: Interventional

Study Design: Open Label, noncomparative, pilot trial.

IMP: Food Supplement

No. of clinical sites/countrie(s): 3/Romania

Sponsor: SIFI MedTech Italy

Condition: Cataract

Title: A multicentre, controlled, randomised, single-blind, two-armed, non-inferiority trial evaluating the visual performance, quality of vision and subjective outcomes with a 6 months follow up after bilateral implantation of Mini Well ready®, a progressive extended depth of focus intraocular lens, or Finevision® , a trifocal intraocular lens, in patients with cataract surgery.

NCT: 03060954

Study Phase: III

Study Type: Interventional

Study Design: A multicentre, controlled, randomised, single-blind, two-armed, non-inferiority trial

IMP: Medical device

No. of clinical sites/countrie(s): 2/France

Prof. Béatrice Cochener ~ Ophtalmologie Hôpital Morvan, Brest

Dr. Pascal Rozot MD ~ Clinique Juge, Marseille

Sponsor: Bioplax Limited

Condition: Infant teething

Title: Performance and tolerability of a new medical device protective gel for the symptomatic relieve of pain due to teething in infants: a randomized , open label, parallel-groups, multicenter study versus Dentinox®- Gel N (Tincture of Chamomile, Lidocaine Hydrochloride, Polidicanol 600).

Study Type: Interventional

Study Design: a randomized , open label, parallel-groups, multicenter trial

IMP: Medical device

No. of clinical sites/countrie(s): 2/Romania