432 matching studies

Sponsor Condition of Interest
Palbociclib in Real World Practice
Pfizer Advanced Breast Cancer Metastatic Breast Cancer
This Non-Interventional Study will describe and analyze the clinical use of palbociclib in routine clinical practice in the treatment of advanced breast cancer. expand

This Non-Interventional Study will describe and analyze the clinical use of palbociclib in routine clinical practice in the treatment of advanced breast cancer.

Type: Observational

Start Date: Jan 2017

open study

Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants
NICHD Neonatal Research Network Neurocognitive Neuroprotective Neonatal Neurodevelopmental Impairment
Study Hypothesis: Preterm infants administered weekly Darbe during the neonatal period will have improved neurocognitive outcome at 22-26 months compared to placebo expand

Study Hypothesis: Preterm infants administered weekly Darbe during the neonatal period will have improved neurocognitive outcome at 22-26 months compared to placebo

Type: Interventional

Start Date: Sep 2017

open study

Study of the Effect IL 7/ NT-I7 on CD4 Counts in Patients With High Grade Gliomas
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Lymphopenia Malignant Glioma
The purpose of this study is to determine the maximum tolerated dose (MTD) and select optimal biological doses (OBD) of the study drug NT-17 in High Grade Glioma patients with severe lymphopenia, as well as to test the effect of NT-17 on the CDR counts of patients in comparison... expand

The purpose of this study is to determine the maximum tolerated dose (MTD) and select optimal biological doses (OBD) of the study drug NT-17 in High Grade Glioma patients with severe lymphopenia, as well as to test the effect of NT-17 on the CDR counts of patients in comparison to control participants. This study has both a Phase I and Pilot component.

Type: Interventional

Start Date: Oct 2018

open study

A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix
The George Washington University Biostatistics Center Short Cervical Length
This protocol outlines a randomized trial of 630 women evaluating the use of micronized vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in women carrying twins and with a cervical length of less than 30 millimeters. expand

This protocol outlines a randomized trial of 630 women evaluating the use of micronized vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in women carrying twins and with a cervical length of less than 30 millimeters.

Type: Interventional

Start Date: Nov 2015

open study

A Study of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) Alone or in Combination With...
Hoffmann-La Roche Multiple Myeloma
This multicenter, open-label, Phase I study will evaluate the safety, efficacy, and pharmacokinetics of atezolizumab alone or in combination with daratumumab and/or various immunomodulatory agents in participants with MM who have relapsed or who have undergone autologous stem... expand

This multicenter, open-label, Phase I study will evaluate the safety, efficacy, and pharmacokinetics of atezolizumab alone or in combination with daratumumab and/or various immunomodulatory agents in participants with MM who have relapsed or who have undergone autologous stem cell transplantation (ASCT). Cycle length will be 21 days in Cohorts A to C and 28 days in Cohorts D to F.

Type: Interventional

Start Date: Jul 2015

open study

A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
Center for International Blood and Marrow Transplant Research Hematologic Malignancies Inherited Disorders of Metabolism Inherited Abnormalities of Platelets Histiocytic Disorders Acute Myelogenous Leukemia (AML or ANLL)
This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications. expand

This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.

Type: Observational

Start Date: Oct 2011

open study

A 12-week Study Treating Participants Who Have alpha1-antitrypsin-related COPD With Alvelestat (MPH966)...
Mereo BioPharma Alpha 1-Antitrypsin Deficiency Emphysema COPD
The purpose of this study is to investigate the effect of alvelestat (an oral neutrophil elastase inhibitor) on blood and sputum biomarkers in patients with Pizz or null genotype alpha-1 anti-trypsin deficient lung disease. Change in a number of different blood and sputum biomarkers... expand

The purpose of this study is to investigate the effect of alvelestat (an oral neutrophil elastase inhibitor) on blood and sputum biomarkers in patients with Pizz or null genotype alpha-1 anti-trypsin deficient lung disease. Change in a number of different blood and sputum biomarkers related to lung damage, inflammation and elastase activity will be measured over a 12 week period. The effect on lung function and respiratory symptoms will also be measured.

Type: Interventional

Start Date: Oct 2018

open study

An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia
Amplyx Pharmaceuticals Candidemia
This is a multicenter, open-label, non-comparative, single-arm study to evaluate the efficacy and safety of APX001 for the first-line treatment for candidemia including suspected or confirmed antifungal-resistant candidemia in non-neutropenic patients 18 to 80 years of age (inclusive).... expand

This is a multicenter, open-label, non-comparative, single-arm study to evaluate the efficacy and safety of APX001 for the first-line treatment for candidemia including suspected or confirmed antifungal-resistant candidemia in non-neutropenic patients 18 to 80 years of age (inclusive). Suspicion of antifungal-resistant candidemia is sufficient (documented resistance is not required for enrollment). The Study Drug Treatment Period of APX001 will be a maximum of 14 days. After completion of 14 days study drug therapy, if further antifungal treatment is indicated to complete treatment of candidemia in accordance with standard practice guidelines, fluconazole (unless susceptibility results warrant alternative antifungal therapy) may commence for up to a further 7 days. There will be a Follow up Period of 4 weeks (+4 days) after EOT. The total duration of participation in the study is up to approximately 7.5 weeks. This study will be conducted at approximately 20 sites in the United States and globally.

Type: Interventional

Start Date: Oct 2018

open study

Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in up to 42 Adult Patients With Acromegaly Being...
Ionis Pharmaceuticals, Inc. Acromegaly
The purpose is to assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in up to 42 Patients with Acromegaly expand

The purpose is to assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in up to 42 Patients with Acromegaly

Type: Interventional

Start Date: May 2018

open study

A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque...
Eli Lilly and Company Plaque Psoriasis
The purpose of this study is to compare the efficacy and safety of ixekizumab to guselkumab in participants with moderate-to-severe plaque psoriasis. expand

The purpose of this study is to compare the efficacy and safety of ixekizumab to guselkumab in participants with moderate-to-severe plaque psoriasis.

Type: Interventional

Start Date: Nov 2018

open study

The VOLTAIRE-X Trial Looks at the Effect of Switching Between Humira® and BI 695501 in Patients With...
Boehringer Ingelheim Psoriasis
The primary objective of the trial is to assess the PK similarity between patients receiving Humira® continuously vs those who alternate between BI 695501 and Humira®, in patients with moderate-to-severe chronic plaque psoriasis. The secondary objectives of this trial are to... expand

The primary objective of the trial is to assess the PK similarity between patients receiving Humira® continuously vs those who alternate between BI 695501 and Humira®, in patients with moderate-to-severe chronic plaque psoriasis. The secondary objectives of this trial are to descriptively compare the safety, immunogenicity and efficacy profiles between patients receiving Humira® continuously vs those who alternate between BI 695501 and Humira®.

Type: Interventional

Start Date: Jul 2017

open study

Individualized Cognitive Training in HIV
University of Alabama at Birmingham HIV-Associated Cognitive Motor Complex Aging Cognitive Impairment Cognitive Decline Attention Impaired
Over 50% of adults with HIV have some form of HIV-Associated Neurocognitive Disorder (HAND) which represents a significant symptom that interferes with everyday functioning and quality of life. As adults age with HIV, they are more likely to develop comorbidities such as cardiovascular... expand

Over 50% of adults with HIV have some form of HIV-Associated Neurocognitive Disorder (HAND) which represents a significant symptom that interferes with everyday functioning and quality of life. As adults age with HIV, they are more likely to develop comorbidities such as cardiovascular disease, hypertension, and insulin resistance which will further contribute to poorer cognitive functioning and HAND. Based upon the Frascati criteria, HAND is diagnosed when a person performs less than 1 to 2 SD below their normative mean (education & age) on measures of two or more cognitive domains (e.g., attention, speed of processing, verbal memory, executive functioning). Yet, from the cognitive literature and prior studies, administering certain computerized cognitive training programs may improve specific cognitive domains in older adults and those with HIV. Such cognitive training programs may be effective in older adults with HIV and therefore investigators may be able to change the diagnosis of HAND in such cognitively vulnerable adults. In this pre-post experimental study, 146 older adults (50+) with HAND will be randomized to be in either: 1) the Individualied-Targeted Cognitive Training, or 2) a no-contact control group. The investigators will focus on those cognitive domains in which participants express an impairment and train them with the corresponding cognitive program. Such an Individualized-Targeted Cognitive Training approach using standard cognitive training programs may offer hope and symptom relief to those individuals diagnosed with HAND. Furthermore, these changes may result in improved everyday functioning (e.g., IADLs) and quality of life. This approach represents a paradigm shift in possibly changing the way HAND is examined. Specific Aim 1: Compare adults who do receive Individualized-Targeted Cognitive Training to those who do not in order to determine whether a change in HAND prevalence and severity occurs between groups. Exploratory Aim 1: Compare adults who do receive individualized-targeted cognitive training to those who do not in order to determine whether this improves everyday functioning (e.g., IADLs). Exploratory Aim 2: Determine whether improvements in HAND and/or everyday functioning over time mediate improvements in quality of life.

Type: Interventional

Start Date: Jul 2017

open study

Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION 2)
Celsion Epithelial Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer
This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone. expand

This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.

Type: Interventional

Start Date: Sep 2018

open study

A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate...
Eli Lilly and Company Psoriasis
The reason for this study is to see how effective and safe mirikizumab is compared to secukinumab and placebo for moderate to severe plaque psoriasis. expand

The reason for this study is to see how effective and safe mirikizumab is compared to secukinumab and placebo for moderate to severe plaque psoriasis.

Type: Interventional

Start Date: Jun 2018

open study

Human iPSC for Repair of Vasodegenerative Vessels in Diabetic Retinopathy
University of Alabama at Birmingham Diabetes Complications Diabetic Retinopathy
This study proposes to carefully examine the hypothesis that human inducible pluripotent stem cells (iPSCs) can be effectively employed as a future therapeutic option for individuals with diabetic retinopathy and macular ischemia. iPSCs will be generated from the peripheral blood... expand

This study proposes to carefully examine the hypothesis that human inducible pluripotent stem cells (iPSCs) can be effectively employed as a future therapeutic option for individuals with diabetic retinopathy and macular ischemia. iPSCs will be generated from the peripheral blood cells of subjects with diabetes and age matched controls. The human iPSC cells will be used to generate mesoderm cells for injection into the vitreous cavity of diabetic rodents and primate eyes. The ability of mesoderm cells to generate endothelial cells and pericytes in areas of degenerated capillaries will be examined. The human iPSCs will also be used to generate hematopoietic CD34+CD45+ cells. The combination of CD34+CD45+ cells derived from iPSCs and iPSC derived mesoderm will be examined in combination for their potentially beneficial effect to enhance the vessel formation.

Type: Observational

Start Date: Jan 2018

open study

Dyslipidemia and Diabetic Retinopathy
University of Alabama at Birmingham Diabetic Retinopathy Dyslipidemia
The purpose of this study is to determine if the reparative cells of blood vessels called endothelial progenitor cells(EPC) are defective in people with diabetes. expand

The purpose of this study is to determine if the reparative cells of blood vessels called endothelial progenitor cells(EPC) are defective in people with diabetes.

Type: Observational

Start Date: Jan 2014

open study

P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
CeraPedics, Inc Degenerative Disc Disease
The aim of this trial is to evaluate if P-15L bone graft (investigational device) is not inferior in effectiveness and safety to local autologous bone (and allograft where necessary) as an extender (control device) when applied in instrumented transforaminal lumbar interbody... expand

The aim of this trial is to evaluate if P-15L bone graft (investigational device) is not inferior in effectiveness and safety to local autologous bone (and allograft where necessary) as an extender (control device) when applied in instrumented transforaminal lumbar interbody fusion (TLIF) in subjects with degenerative disc disease (DDD). In addition to the general overall objective, a sub-group analysis will be performed on the high-risk subject population (tobacco use, obesity, diabetes), as previous studies have shown negative effects of smoking, obesity and diabetes on fusion and bone healing, increased peri/postoperative complications, and lower patient-reported outcome scores.

Type: Interventional

Start Date: Apr 2018

open study

A Study of IMO-2125 in Combination With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1...
Idera Pharmaceuticals, Inc. Metastatic Melanoma
A Phase 3 comparison of ipilimumab with and without IMO-2125 in advanced melanoma expand

A Phase 3 comparison of ipilimumab with and without IMO-2125 in advanced melanoma

Type: Interventional

Start Date: May 2018

open study

Study to Assess Safety and Preliminary Activity of Eribulin Mesylate in Pediatric Participants With Relapsed/Refractory...
Eisai Inc. Relapsed/Refractory Rhabdomyosarcoma Non-rhabdomyosarcoma Soft Tissue Sarcoma Ewing Sarcoma
This study will be conducted as an assessment of the safety and preliminary activity of eribulin mesylate in pediatric participants with relapsed/refractory rhabdomyosarcoma (RMS), non-rhabdomyosarcoma soft tissue sarcoma (NRSTS), or Ewing sarcoma (EWS) to determine whether each... expand

This study will be conducted as an assessment of the safety and preliminary activity of eribulin mesylate in pediatric participants with relapsed/refractory rhabdomyosarcoma (RMS), non-rhabdomyosarcoma soft tissue sarcoma (NRSTS), or Ewing sarcoma (EWS) to determine whether each cohort warrants further investigation.

Type: Interventional

Start Date: Apr 2018

open study

Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic...
Seattle Genetics, Inc. Breast Neoplasms
This trial studies SGN-LIV1A in combination with pembrolizumab to find out what their side effects are and if they work for patients with triple-negative breast cancer that has spread to other parts of the body. Patients will be given both experimental drugs every 3 weeks. expand

This trial studies SGN-LIV1A in combination with pembrolizumab to find out what their side effects are and if they work for patients with triple-negative breast cancer that has spread to other parts of the body. Patients will be given both experimental drugs every 3 weeks.

Type: Interventional

Start Date: Feb 2018

open study

Monoclonal Antibody-Based Sequential Therapy for Deep Remission in Multiple Myeloma
University of Alabama at Birmingham Multiple Myeloma
Multiple myeloma (MM), a plasma cell disorder, is the second most common hematologic malignancy in the U.S. No standard curative therapy has yet been found. A variety of therapeutic measures including high dose melphalan, induction therapy, and continuous therapy have been used... expand

Multiple myeloma (MM), a plasma cell disorder, is the second most common hematologic malignancy in the U.S. No standard curative therapy has yet been found. A variety of therapeutic measures including high dose melphalan, induction therapy, and continuous therapy have been used but the goal of complete response without relapse has not been achieved. More active treatment regimens and better tools for response assessment are needed.

Type: Interventional

Start Date: Mar 2018

open study

A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in...
Hoffmann-La Roche Ovarian Cancer Fallopian Tube Cancer Peritoneal Neoplasms
This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo + paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian cancer... expand

This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo + paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will undergo neoadjuvant therapy followed by interval surgery.

Type: Interventional

Start Date: Mar 2017

open study

Aspirin in Preventing Recurrence of Cancer in Patients With HER2 Negative Stage II-III Breast Cancer...
Alliance for Clinical Trials in Oncology Node Positive HER2 Negative Breast Cancer
This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces... expand

This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer.

Type: Interventional

Start Date: Dec 2016

open study

Trial of Hu5F9-G4 in Combination With Rituximab in Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
Forty Seven, Inc. Lymphoma, Non-Hodgkin Lymphoma, Large B-Cell, Diffuse Indolent Lymphoma
This Phase 1b/2 trial will evaluate Hu5F9-G4 in combination with rituximab. Hu5F9-G4 is a monoclonal antibody which is designed to block a protein called CD47, which is widely expressed on human cancer cells. Blocking CD47 with Hu5F9-G4 may enable the body's immune system to... expand

This Phase 1b/2 trial will evaluate Hu5F9-G4 in combination with rituximab. Hu5F9-G4 is a monoclonal antibody which is designed to block a protein called CD47, which is widely expressed on human cancer cells. Blocking CD47 with Hu5F9-G4 may enable the body's immune system to find and destroy the cancer cells. Rituximab is a monoclonal antibody drug that is used for treatment of non-Hodgkin's lymphoma and other types of cancer. The major aims of the trial are: (Phase 1b) to investigate the safety and tolerability of sequential dose cohorts and to determine a recommended Phase 2 dose for Hu5F9-G4 in combination with rituximab, and (Phase 2) to evaluate the efficacy of Hu5F9-G4 in combination with rituximab in patients with indolent lymphoma or diffuse large B-cell lymphoma as measured by the overall response rate.

Type: Interventional

Start Date: Nov 2016

open study

Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental...
Astellas Pharma Global Development, Inc. Kidney Transplantation Focal Segmental Glomerulosclerosis (FSGS)
The purpose of this study is to assess the efficacy of the bleselumab regimen (basiliximab induction, tacrolimus, steroids and bleselumab) compared with the Standard of Care (SOC) regimen (basiliximab induction, tacrolimus, steroids and mycophenolate mofetil [MMF]) in the prevention... expand

The purpose of this study is to assess the efficacy of the bleselumab regimen (basiliximab induction, tacrolimus, steroids and bleselumab) compared with the Standard of Care (SOC) regimen (basiliximab induction, tacrolimus, steroids and mycophenolate mofetil [MMF]) in the prevention of recurrent Focal Segmental Glomerulosclerosis (rFSGS) defined as nephrotic range proteinuria with protein-creatinine ratio (≥ 3.0 g/g) through 3 months post-transplant. Death, graft loss or lost to follow-up will be imputed as rFSGS.

Type: Interventional

Start Date: May 2017

open study