Clinical trials: Therapy Failure
Aortic Stenosis, Mitral Stenosis
ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)
The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their…
- Conditions
- Aortic Stenosis, Mitral Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- COMMENCE (NCT01757665)
- Testing
- Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M
- Where
- 32 sites in United States, Canada and 1 more
- Volunteers
- 777 people
- Sponsor
- Edwards Lifesciences
Heart Failure, Ventricular Dyssynchrony
Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)
The EchoCRT trial evaluates the effects of Cardiac Resynchronization Therapy (CRT) on mortality and morbidity of subjects with heart failure due to left ventricular systolic dysfunction, already receiving optimized HF medication…
- Trial name
- EchoCRT (NCT00683696)
- Testing
- Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)
- Where
- 122 sites in United States, Australia and 15 more
- Volunteers
- 1,680 people
- Sponsor
- Biotronik, Inc.
Kidney Failure, Chronic Therapy; Hemodialysis
A Single Ascending Dose Study of Soluble Ferric Pyrophosphate Administered Intravenously in Healthy Volunteers.
The purpose of this study is to determine the pharmacokinetics of fixed ascending doses of intravenously administered Soluble Ferric Pyrophosphate
- Trial name
- NCT01920854
- Testing
- soluble ferric pyrophosphate
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Rockwell Medical Technologies, Inc.
Acute Heart Failure
Study of Safety, Tolerability and Pharmacokinetics of Serelaxin in Japanese Acute Heart Failure (AHF) Patients
This is a multicenter, randomized, double-blind, placebo-controlled study to assess safety, tolerability and pharmacokinetics and to explore efficacy of IV infusion of 10 µg/kg/day and 30 µg/kg/day serelaxin for 48 hours compared…
- Trial name
- NCT02002702
- Testing
- Serelaxin
- Where
- 15 sites in Japan
- Volunteers
- 46 people
- Sponsor
- Novartis Pharmaceuticals
Colorectal Carcinoma, CRC
Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma
The purpose of this study is to evaluate the safety, tolerability, and efficacy of JX-594 (Pexa-Vec) administered intravenously either alone or in combination with Irinotecan in colorectal carcinoma patients who are refractory to…
- Trial name
- NCT01394939
- Testing
- JX-594, Irinotecan
- Where
- 11 sites in United States, Canada and 1 more
- Volunteers
- 52 people
- Sponsor
- Jennerex Biotherapeutics
Fecal Incontinence
Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence
The purpose of this study is to demonstrate that the TOPAS System effectively treats fecal incontinence in women as measured by a 50% reduction in the number of FI episodes in a 14 day bowel diary at 12 months.
- Trial name
- TRANSFORM (NCT01090739)
- Testing
- TOPAS Treatment for Fecal Incontinence
- Where
- 14 sites in United States
- Volunteers
- 207 people
- Sponsor
- ASTORA Women's Health
Lung Cancer
PF-00299804 in Stage IIIB or Stage IV Non-Small Cell Lung Cancer Not Responding to Standard Therapy for Advanced or Metastatic Cancer
RATIONALE: PF-00299804 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether PF-00299804 is more effective than a placebo in treating patients with advanced…
- Trial name
- NCT01000025
- Testing
- PF-00299804
- Where
- 89 sites in United States, Argentina and 10 more
- Volunteers
- 720 people
- Sponsor
- NCIC Clinical Trials Group
CKD Anemia
A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis
The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants with chronic kidney disease and not on dialysis.
- Trial name
- NCT01750190
- Testing
- Roxadustat
- Where
- 145 sites in United States, Argentina and 14 more
- Volunteers
- 922 people
- Sponsor
- Kyntra Bio
End Stage Renal Disease (ESRD), Diabetes
Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients
Primary Objective: To demonstrate that use of glucose sparing prescriptions, Dianeal, Extraneal, Nutrineal (D-E-N) versus Dianeal only, in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) patients…
- Conditions
- End Stage Renal Disease (ESRD), Diabetes, CAPD
- Trial name
- EDEN (NCT01219959)
- Testing
- Dianeal, Dianeal, Extraneal, Nutrineal
- Where
- 16 sites in Colombia
- Volunteers
- 71 people
- Sponsor
- Vantive Health LLC
Hepatorenal Syndrome
Treatment of Type I Hepatorenal Syndrome (HRS) With Pentoxyfylline
Pentoxyfylline therapy in addition to the standard of care of albumin, midodrine and octreotide therapy is superior to the standard of care alone in the treatment of Type I hepatorenal syndrome in the first 14 days of…
- Trial name
- NCT02123576
- Testing
- Pentoxyfylline, AMO Therapy
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Patrick Northup, MD
Anemia in Incident Dialysis Patients
Safety and Efficacy Study of Roxadustat (FG-4592) for the Treatment of Anemia in End-Stage Renal Disease (ESRD) Newly Initiated Dialysis Participants
The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants who have just begun dialysis treatment for ESRD.
- Trial name
- Himalayas (NCT02052310)
- Testing
- Roxadustat, Epoetin Alfa
- Where
- 113 sites in United States, Argentina and 13 more
- Volunteers
- 1,043 people
- Sponsor
- Kyntra Bio
Acute Myelogenous Leukemia, Lymphoid Leukemia
T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies
Objectives: 1. To evaluate disease free survival after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies. 2.
- Conditions
- Acute Myelogenous Leukemia, Lymphoid Leukemia, Chronic Myelogenous Leukemia, Malignant Lymphoma
- Trial name
- NCT00683046
- Testing
- Fludarabine, Melphalan, Stem cells
- Where
- United States
- Volunteers
- 204 people
- Sponsor
- University of Chicago
Heart Failure
Attain Performa(TM) Quadripolar Lead Study
The purpose of the study is to evaluate the safety and efficacy of the Medtronic Attain Performa Quadripolar Leads (Model 4298, 4398, and 4598) during and post the implant procedure.
- Trial name
- NCT01751022
- Testing
- Device: Attain Performa Pacing Lead (along with a standard CRT-D system)
- Where
- 121 sites in United States, Australia and 25 more
- Volunteers
- 1,202 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Severe Aplastic Anemia (SAA)
Combination of Eltrombopag With Immunosuppressive Therapy in East-Asian Patients With Severe Aplastic Anemia
This study was designed to evaluate the efficacy and safety of eltrombopag when added to r-ATG and CsA in treatment naive East-Asian adult and pediatric patients with severe aplastic anemia (SAA).
- Trial name
- REACTS (NCT04328727)
- Testing
- eltrombopag, rabbit anti-thymocyte globulin (r-ATG), cyclosporine A (CsA)
- Where
- 12 sites in China, Japan and 2 more
- Volunteers
- 36 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure
The Effects of Sacubitril/Valsartan on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Heart Failure Patients
This is a phase IV, prospective, randomized, double-blind, double-dummy, parallel-group study. The study assessed the effects of 6 weeks of stable sacubitril/valsartan therapy, as compared with valsartan therapy, on the…
- Trial name
- TurkuPET (NCT03300427)
- Testing
- sacubitril/valsatran, valsartan
- Where
- Finland
- Volunteers
- 55 people
- Sponsor
- Novartis Pharmaceuticals
Critically Ill Renal Failure Requiring CVVHD and Oseltamivir, Critically Ill Requiring ECMO and Oseltamivir
Pharmacokinetics of Tamiflu® (Oseltamivir) in Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)and or Continuous Venovenous Hemodialysis (CVVHD)
Critically ill patients with flu may receive a drug called oseltamivir. They may also receive medical therapies to support their lung function (extracorporeal membrane oxygenation; ECMO) and kidney function (continuous venovenous…
- Trial name
- NCT01048879
- Testing
- pharmacokinetic blood sampling, pharmacokinetic blood and dialysate sampling
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Michigan
HIV-1-infection
Population Effectiveness of Dolutegravir Implementation in Sub-Saharan Africa
This is a prospective observational cohort study enrolling participants in South Africa and Uganda who are prescribed an HIV treatment regimen containing lamivudine, tenofovir, and dolutegravir, which is known as TLD.
- Trial name
- DISCO (NCT04066036)
- Testing
- This is an observational study only.
- Where
- 2 sites in South Africa, Uganda
- Volunteers
- 999 people
- Sponsor
- Massachusetts General Hospital
Hepatitis C Virus Infection
Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study
The purpose of this study was to evaluate the efficacy and safety of co-administration of glecaprevir (ABT-493)/pibrentasvir (ABT 530) plus sofosbuvir (SOF) plus ribavirin (RBV) in hepatitis C virus (HCV) genotype (GT) 1 …
- Trial name
- MAGELLAN-3 (NCT02939989)
- Testing
- Sofosbuvir, Glecaprevir/Pibrentasvir, Ribavirin
- Where
- 26 sites in United States, Australia and 10 more
- Volunteers
- 33 people
- Sponsor
- AbbVie
Symptomatic Paroxysmal Atrial Fibrillation (PAF)
FIRE AND ICE: Comparative Study of Two Ablation Procedures in Patients With Atrial Fibrillation
Comparing efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus a radiofrequency ablation with a ThermoCool catheter in patients with paroxysmal atrial fibrillation.
- Trial name
- NCT01490814
- Testing
- Electrical isolation of the pulmonary veins, Electrical isolation of pulmonary veins
- Where
- 19 sites in Czechia, France and 6 more
- Volunteers
- 769 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Heart Failure
HCV Positive Heart Donors
Study subjects active on the waiting list for a heart transplant at the NYU Langone Transplant Institute who are hepatitis C (HCV) negative will receive a heart transplant from a donor who tests positive for HCV.
- Trial name
- NCT03382847
- Testing
- Transplant with HCV positive donor, followed by surveillance and treatment of viremia
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- NYU Langone Health