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NCT ID: NCT02064829 Completed - Clinical trials for Metastatic Breast Cancer

Bioequivalence Study of IG-001 Versus Nab-paclitaxel in Metastatic or Locally Recurrent Breast Cancer

TRIBECA
Start date: March 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate bioequivalence of IG-001 versus nab-paclitaxel in female patients with metastatic or locally recurrent breast cancer. In addition, the study will compare the safety and tolerance of IG-001 and nab-paclitaxel during the bioequivalence 2-period crossover portion of the study. The study will also evaluate the long-term safety of IG-001 over repeated cycles, up to 4 additional cycles of administration.

NCT ID: NCT02064153 Completed - Hypotension Clinical Trials

Studying the Effect of Dialysate Temperature on Toxin Removal and Hypotension

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

Hemodialysis (HD) is widely used treatment for end stage renal diseases (ESRD) patients. The chief aims of HD are solute and fluid removal. Decades of practice have improved HD care, but more can be done to improve morbidity and mortality. Enhancing toxin removal is an important consideration for improved patient outcomes. Also, decreasing the incidence of intra-dialytic hypotensive (IDH) episodes (dominant in Singapore patient cohort) can significantly reduce associated morbidities and mortality. A simple maneuver for clinicians is the dialysate temperature. Literature suggests that a lower dialysate temperature (35ºC) results in reduced hypotensive episodes by vasoconstriction. Conversely, higher dialysate temperature resulting in higher blood temperature decreases the peripheral resistance, leading to increased toxin removal, but may cause IDH episodes partly due to vasodilation. Optimal manipulation of the dialysate temperature is therefore primary handles to obtain the improved patient outcomes. In this study, the effect of dialysate temperature (cool vs. warm dialysate) on toxin removal will be studied. In both the interventions, outcome measure will be patient hemodynamic response and amount of toxins removed. The spent dialysate will be collected to study the quantum of toxin removed.

NCT ID: NCT02062684 Completed - IgA Nephropathy Clinical Trials

BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous Administration

Start date: June 2013
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of subcutaneous blisibimod administration in addition to standard therapy in patients with biopsy proven IgA Nephropathy with persistent proteinuria of between 1-6 g/day.

NCT ID: NCT02057380 Completed - Clinical trials for Advanced Solid Tumors

A Rollover Study for Subjects That Have Participated in an Astellas Sponsored Linsitinib Trial

Start date: April 16, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to provide access to continued treatment for subjects who participated in other Astellas sponsored trials and for whom the investigator feels the subject may benefit from continued treatment.

NCT ID: NCT02045862 Completed - Overactive Bladder Clinical Trials

A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder

SYNERGY II
Start date: March 17, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to examine how well the combination of two medicines (solifenacin succinate and mirabegron) worked compared to each medicine alone in the treatment of bladder problems, and how safe they were for long term use.

NCT ID: NCT02043795 Completed - Clinical trials for Critical Limb Ischemia

Drug Impregnated Bioabsorbable Stent in Asian Population Extremity Arterial Revascularization (DISAPEAR Study)

DISAPEAR
Start date: July 1, 2013
Phase: N/A
Study type: Interventional

The aim of this study is to study the safety and clinical efficacy of a novel Bioabsorbable Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS, Abbott Vascular) in subjects with critical limb ischemia (CLI) following percutaneous transluminal angioplasty (PTA) of the tibial arteries.

NCT ID: NCT02043678 Completed - Prostatic Neoplasms Clinical Trials

Radium-223 Dichloride and Abiraterone Acetate Compared to Placebo and Abiraterone Acetate for Men With Cancer of the Prostate When Medical or Surgical Castration Does Not Work and When the Cancer Has Spread to the Bone, Has Not Been Treated With Chemotherapy and is Causing no or Only Mild Symptoms

ERA 223
Start date: March 30, 2014
Phase: Phase 3
Study type: Interventional

To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs to be treated with an X-ray machine.

NCT ID: NCT02043288 Completed - Clinical trials for Pancreatic Neoplasms

Combination Therapy With NC-6004 and Gemcitabine Versus Gemcitabine Alone in Pancreatic Cancer

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

This clinical trial is designed to evaluate the impact of the addition of NC-6004 to gemcitabine in the treatment of patients with locally advanced or metastatic pancreatic cancer in Asian countries.

NCT ID: NCT02042898 Completed - Clinical trials for Disorder; Heart, Functional, Postoperative, Cardiac Surgery

Transfusion Requirements in Cardiac Surgery III

TRICS-III
Start date: January 20, 2014
Phase: N/A
Study type: Interventional

TRICS-III is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in high risk patients having cardiac surgery using a non-inferiority trial design.

NCT ID: NCT02042144 Completed - Neoplasms Clinical Trials

Safety and Effectiveness of Regorafenib

Correlate
Start date: April 8, 2014
Phase: N/A
Study type: Observational

This study is a prospective observational cohort study. The study will be conducted in routine clinical practice settings. It is planned to enroll 1000 patients with metastatic Colorectal Cancer (mCRC) who have been previously treated with other approved treatments for metastatic disease and for whom a decision has been made by the physician to treat with regorafenib according to local health authority approved label. It is the aim of this observational cohort study to further characterize safety and effectiveness of regorafenib in routine clinical practice setting. Healthcare resource utilization in the routine provision of care is becoming increasingly important from a health economics and outcomes research perspective. Therefore, another aim of this observational cohort study is to capture healthcare resource associated with the management of treatment emergent adverse events in the real world setting. The primary objective of this study is to further characterize safety of regorafenib use in routine clinical practice settings. The secondary objective of this study is to assess the effectiveness of regorafenib in routine clinical practice settings as measured by Overall Survival (OS), Progression Free Survival (PFS) and Disease control rate (DCR). Health Related Quality of Life (HRQoL) Data will be collected in applicable countries.