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NCT ID: NCT02768870 Completed - Clinical trials for Mitral Valve Insufficiency

CE Mark Study for the Harpoon Medical Device

TRACER
Start date: April 28, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and performance of the Harpoon Medical device. It is anticipated, that the Harpoon Medical device will provide advantages over current surgical interventions including: 1) a small minimally invasive incision, 2) no sternotomy, 3) no cardiopulmonary bypass, 4) no aortic manipulation, 5) a direct path to the valve plane, 6) performed on a beating heart, 7) real-time TOE-guided chordal length adjustment and 8) less complicated procedure that is teachable and adoptable.

NCT ID: NCT02767765 Completed - Anemia Clinical Trials

A Study of Recombinant Human Erythropoietin Beta (NeoRecormon) in Anemic Cancer Participants Treated With Chemotherapy

Start date: June 2003
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and tolerability of subcutaneous (SC) or intramuscular (IM) recombinant human erythropoietin beta (r-HuEPO) in participants with anemia and histologically or cytologically confirmed cancer.

NCT ID: NCT02766127 Completed - Xerostomia Clinical Trials

Effect of a Self-adhering Material in Dental Hypersensitivity

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

Aim: To compare the desensitizing capacity of Vertise Flow™ (VF), a new self adhering material, in the treatment of dentine hypersensitivity (DH) in patients who are xerostomic due to radiotherapy for head and neck cancer. Methods: A total of 17 patients were selected for the study. The study was conducted as a split-mouth randomized clinical trial comparing: 1) VF 2) Universal Dentin Sealant (UDS), 3) Clearfil Protect Bond (CPB) and 4) Flor-Opal® Varnish (FOV). Basal and stimulated salivary flow was recorded for each patient according to the method described by Sreebny. The pain experience was generated by a cold stimulus directly to a sensitive tooth surface and assessed using the Visual Analogue Scale (VAS). The response was recorded before the application of the materials (PRE-1), immediately after (POST-1), at 1-week (POST-2), 4-weeks (POST-3) and 12-week controls (POST-4).

NCT ID: NCT02763579 Completed - Clinical trials for Small Cell Lung Carcinoma

A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)

IMpower133
Start date: June 7, 2016
Phase: Phase 3
Study type: Interventional

This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study was designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC. Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin + etoposide or placebo + carboplatin + etoposide on 21-day cycles for four cycles in the induction phase followed by maintenance with atezolizumab or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.

NCT ID: NCT02763540 Completed - Clinical trials for Interstitial Lung Diseases

Pathological Comparisons of Surgical Open Lung Biopsies and Cryobiopsies in Non-IPF ILD

CryoPID
Start date: January 20, 2016
Phase: N/A
Study type: Interventional

Pathological comparisons of surgical open lung biopsies and cryobiopsies in non-IPF ILD. Patients with non-IPF ILD eligible for an open lung biopsy will undergo cryobiopsy in the same time. Between observers agreement will be assessed for each pairs of samples.

NCT ID: NCT02763137 Completed - Parkinson Disease Clinical Trials

Intermittent Oral Administration vs. Semi-continuous Intra-oral Administration of Levodopa/Carbidopa in Fluctuating Parkinsonian Patients

LDCD-001
Start date: July 30, 2014
Phase: Phase 2
Study type: Interventional

This is a phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and efficacy of intermittent oral administration of standard levodopa/carbidopa (LD/CD) vs.semi-continuous intra-oral administration of levodopa/carbidopa in patients with advanced Parkinson's disease (PD) who suffer motor fluctuations.The objective of this study is to assess the plasma pharmacokinetics (PK) of continuous intra-oral administration of LD/CD vs. intermittent administration of standard oral LD/CD. For purposes of this study continuous intra-oral administration of LD/CD is defined as oral administration of LD/CD at 5-10 minute intervals. Secondary objectives are to assess the safety and tolerability of continuous intra-oral administration of LD/CD and the effect on PD motor function of continuous intra-oral administration of LD/CD vs. intermittent administration of standard oral LD/CD.

NCT ID: NCT02762721 Completed - Cholangiocarcinoma Clinical Trials

Analysis of Oncogenes in Intrahepatic Cholangiocarcinoma or Mixed Hepatocellular-Cholangiocarcinoma in Tumor Tissue Samples

Start date: June 6, 2016
Phase: N/A
Study type: Observational

The primary objective of this study is to estimate the frequency of FGFR2 fusions in archived intrahepatic cholangiocarcinoma (iCCA) or mixed hepatocellular-cholangiocarcinoma (HCC-CCA) tumor samples

NCT ID: NCT02762019 Completed - Stomatitis Clinical Trials

Laser for Oral Mucositis in Pediatric Onco-hematology

LAMPO
Start date: September 2013
Phase: Phase 3
Study type: Interventional

Children with cancer undergoing intensive chemotherapy (CT) regimens experience many side effects among which oral mucositis (OM) is one of the most debilitating. Modifications of CT's schedule and prolonged hospitalization may be necessary in presence of OM, causing poor general conditions and debilitation. Moreover, the use of narcotic analgesics and total parenteral nutrition may be required, triggering not only a physical deficit but also an economic burden. Despite the frequency and impact of OM among children with cancer, there is no consensus on standard therapy for this condition. Previous studies demonstrated that high power laser therapy can help the maintenance of nutritional status in patients with OM and can remarkably reduce costs/resources needed. Laser therapy has evidence of efficacy in reducing symptoms and in preventing the onset of OM in adult cancer patients but only one randomized controlled trial, with a limited number of children enrolled, supports its use in children for treatment of OM induced by chemotherapy. This multicenter double-blind randomized controlled trial evaluates the efficacy of laser for treatment of oral mucositis secondary to chemotherapy in children aged 3-17 years. The study involves 8 italian hospitals.

NCT ID: NCT02761642 Completed - Anemia Clinical Trials

A Study to Evaluate Efficacy and Safety of Epoetin Beta (NeoRecormon®) in Anemic Participants With Breast Cancer Undergoing Chemotherapy

Start date: February 29, 2004
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of subcutaneous (SC) epoetin beta in anemic participants with breast cancer undergoing chemotherapy.

NCT ID: NCT02761252 Completed - Asthma Clinical Trials

Efficacy of Co-administration of Bilastine and Montelukast in Patients With SARC and Asthma

SKY
Start date: April 13, 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare concomitant administration of Montelukast and Bilastine to Montelukast and Bilastine monotherapies in patients with SARC and asthma