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NCT ID: NCT03093870 Completed - Clinical trials for Biliary Tract Cancer

Varlitinib in Combination With Capecitabine for Advanced or Metastatic Biliary Tract Cancer

TreeTopp
Start date: July 4, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

This protocol for Varlitinib is developed for the treatment of Biliary Tract Cancer. Varlitinib (also known as ASLAN001) is a small-molecule, adenosine triphosphate competitive inhibitor of the tyrosine kinases - epidermal growth factor receptor (EGFR), human epidermal growth factor receptor (HER)2, and HER4. Varlitinib may be beneficial to subjects with cancer by simultaneous inhibition of these receptors. The purpose of this study is to determine the safety and efficacy of Varlitinib in combination with capecitabine for the treatment of Biliary Tract Cancer. Treatment groups are Varlitinib+capecitabine and Placebo + capecitabine

NCT ID: NCT03093818 Completed - Clinical trials for Adverse Drug Reaction

PREemptive Pharmacogenomic Testing for Preventing Adverse Drug REactions

PREPARE
Start date: March 20, 2017
Phase: N/A
Study type: Interventional

PREPARE is an international, prospective, multi-center, open, randomized, cross-over implementation study assessing the impact of pre-emptive pharmacogenomic testing, of a panel of actionable pharmacogenomic variants, on adverse event incidence. Additional outcomes include, healthcare expenditure, process indicators for implementation and provider adoption of pharmacogenomics.

NCT ID: NCT03093480 Completed - Clinical trials for Hemophilia A With Inhibitors

A Study to Evaluate Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Participants With Inhibitors Undergoing the First ITI Treatment (verITI-8 Study)

Start date: December 8, 2017
Phase: Phase 4
Study type: Interventional

The primary purpose of this study was to describe the time to tolerization (i.e., ITI success) with rFVIIIFc in participants within a maximum of 48 weeks (12 months) of ITI treatment.

NCT ID: NCT03093259 Completed - Ulcerative Colitis Clinical Trials

ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis

Start date: November 16, 2017
Phase: Phase 2
Study type: Interventional

This Phase IIa study is an 8-week, double-blind, placebo-controlled, randomized study aiming at evaluating the safety and the efficacy of ABX464 given once a day (o.d) at 50 mg in subjects with moderate to severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFα, vedolizumab and/or corticosteroids followed by a one-month follow-up period.

NCT ID: NCT03092869 Completed - Aging Problems Clinical Trials

Effects of Feet and Ankle Mobilization on Balance of Older Adults

FEET_BALANCE
Start date: April 3, 2017
Phase: N/A
Study type: Interventional

This study aims to assess whether mobilization of the ankle and foot produces significant improvements in the balance of the elderly. To this end, a randomized study was designed with a control group that performs proprioception exercises and an experimental group that also performs a mobilization of the ankle and foot joints.

NCT ID: NCT03092739 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study to Assess Programmed Death Ligand-1 (PD-L1) Expression in Cytological Versus Histological Lung Cancer Specimens

Start date: May 3, 2017
Phase:
Study type: Observational

The primary purpose of this non-interventional, multinational study is to assess the feasibility of assessing PD-L1 protein expression on cytological samples as a surrogate for histological samples obtained from participants with any stage of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC).

NCT ID: NCT03091465 Completed - Clinical trials for Metastatic Renal Cell Carcinoma

Validation of the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Prognostic Classification for Targeted Therapies (TKI/mTOR Inhibitors) in Second Line After First Line Treatment With Pazopanib

Spazo-2
Start date: December 20, 2016
Phase:
Study type: Observational

This is a nation-wide retrospective observational study which will be performed in 50 centres in Spain, geographically representative of all regions, with at least 5 patients treated with first-line pazopanib for mRCC in daily clinical practice since April 2011 (date of approval of pazopanib in Spain), January 2016. Pazopanib is one of the standard tyrosine-kinase inhibitors (TKI) for the first-line treatment of metastatic renal cell carcinoma. In our previous SPAZO study, the Spanish Oncologic Genitourinary Group (SOGUG) validated the IMDC prognostic classification for patients receiving first-line pazopanib, and demonstrated the effectiveness of this drug in routine clinical practice. However, in this series of 278 patients, we could not obtain enough information on the effectiveness of pazopanib in special subpopulations such as non-clear cell histologies, and others subgroups, due to a small simple size of each of these subpopulations. On the other hand, after the results of RECORD-1 and AXIS trials, switching to everolimus or axitinib is the current approach for patients who progresses to a first-line TKI. However, these pivotal studies did not include patients treated with first-line pazopanib study because this drug was not available at that time. The results of the SPAZO study also suggested that the effectiveness of second-line targeted therapies (TT) after pazopanib in routine clinical practice is similar to the observed in clinical trials after sunitinib, sorafenib or bevacizumab. In addition, the preliminary results indicated that there are not meaningful differences in the effectiveness of TKI or mTOR inhibitors after pazopanib, when the results are adjusted by the IMDC prognostic classification. However, the IMDC prognostic classification for second-line TT has not yet been validated for patients who receive pazopanib as first-line. In addition our sample size was not large enough to make a comparison of effectiveness between mTOR inhibitors and antiVEGF for each prognostic subgroups of the IMDC. Based on that, the Spanish Oncologic Genitourinary Group has decided to launch the SPAZO-2 study, in which we intend to prolong the follow up of patients included in SPAZO, and to increase the sample size with new patients from new centres, in order to obtain a larger sample in each of the subpopulations of interest, with the objective of obtaining more information about the above questions.

NCT ID: NCT03091322 Completed - Clinical trials for Cardiac Resynchronization Therapy

BIO|MASTER.Edora Family Study

Start date: February 12, 2017
Phase:
Study type: Observational

This study is designed as post market clinical follow-up study with CE-marked products to evaluate the AV Opt and LV VectorOpt features in the respective Edora family pacemakers under clinical conditions. Furthermore, adverse events will be evaluated to identify residual risks associated with the use of the BIOTRONIK Edora family pacemakers. The study is further designed to address potential regulatory needs of clinical data for countries and regions not covered by the CE approval.

NCT ID: NCT03091036 Completed - Preventive Care Clinical Trials

Impact of a Health Intervention on Some Indicators in the Care of Chronic Complex Patient (CCP).

CCP
Start date: July 2015
Phase: N/A
Study type: Interventional

The aim of this study is to assess the effectiveness of proactive and integrated healthcare program for chronic complex patients (CCP). This program are based in coordination the primary level of attention with and speciality level. The objective is reducing hospital readmissions and know the benefit in total cost of care in 4 month before and 4 after intervention.

NCT ID: NCT03090191 Completed - Clinical trials for Clostridium Difficile Infection

Clostridium Difficile Vaccine Efficacy Trial

Clover
Start date: March 29, 2017
Phase: Phase 3
Study type: Interventional

The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium difficile infection. The study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated. Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential Clostridium difficile infection.