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NCT ID: NCT01966471 Completed - Breast Cancer Clinical Trials

A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer

Start date: January 31, 2014
Phase: Phase 3
Study type: Interventional

This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg) intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at a dose of 420 mg IV q3w in combination with a taxane.

NCT ID: NCT01966419 Completed - Clinical trials for Hepatic Encephalopathy

Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)

STOP-HE
Start date: January 7, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.

NCT ID: NCT01966354 Completed - Clinical trials for Ultrasound-guided Internal Jugular Cannulation

Comparison of Three Techniques for Ultrasound-guided Internal Jugular Cannulation

OISO-1
Start date: March 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of three ultrasound assistance techniques for internal jugular venous cannulation, in terms of cannulation success and prevention of complications.

NCT ID: NCT01965912 Completed - Phenylketonuria Clinical Trials

Kuvan®'s Effect on the Cognition of Children With Phenylketonuria

KOGNITO
Start date: October 2013
Phase: Phase 4
Study type: Interventional

The study is a single-cohort, interventional, open-label trial to evaluate long-term neurocognitive (NC) outcomes in children aged 4 to 5 years with phenylketonuria (PKU) treated with Kuvan® and Phenylalanine-restricted diet over a period of 7 years.

NCT ID: NCT01965652 Completed - Clinical trials for Opioid-induced Constipation

Long Term Safety of Naldemedine

Start date: September 24, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety of naldemedine for the treatment of constipation due to opioid therapy.

NCT ID: NCT01965288 Completed - Astigmatism Clinical Trials

Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism

Start date: September 2013
Phase: N/A
Study type: Interventional

The aim of this study is to compare the clinical performance of the Biofinity Toric (comfilcon A) contact lens, versus Air Optix for Astigmatism (lotrafilcon B) over 1 month of daily wear.

NCT ID: NCT01965158 Completed - Clinical trials for Opioid-induced Constipation

Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation

Start date: August 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in subjects with non-malignant chronic pain who are not using laxatives

NCT ID: NCT01965015 Completed - Clinical trials for Congestive Heart Failure

The V-Wave Shunt: FIM Safety and Feasibility Study

VW-SP-1
Start date: April 1, 2014
Phase: N/A
Study type: Interventional

The V-Wave atrial-septal shunt implant is intended for the reduction of elevated left atrial filling pressures ('Left Atrial Decompression') in chronic, New York Heart Association (NYHA) class III -IV, Heart Failure (HF) patients. This is a First In Man (FIM) study, aimed to enable a first evaluation of the safety and performance of the V-Wave shunt implant when implanted in Chronic Heart Failure patients. Prospective, open label, single-arm study with intra-patient comparisons (i.e. subjects' status will be compared to their pre-implant (baseline) status.

NCT ID: NCT01964989 Completed - Influenza Virus Clinical Trials

Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.

Start date: November 2013
Phase: Phase 3
Study type: Interventional

Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to <72 Months of Age. The study was conducted during the 2013/2014 and 2014/2015 northern hemisphere influenza season.

NCT ID: NCT01964443 Completed - Psoriasis Clinical Trials

Clinical Assessment and Psychosocial Impact of Psoriasis

EPIDEPSO
Start date: September 2013
Phase: Phase 4
Study type: Observational

The purpose of this study is to explore the impact of plaque psoriasis on the different dimensions of patient life including psychological disorders, different types of addictions, and their consequences on health-related quality of life and socioeconomic parameters at baseline (cross-sectional part) and during the initial years of the psoriasis disease (longitudinal part).