472 matching studies

Sponsor Condition of Interest
Study Evaluating the Safety and Efficacy of JCARH125 in Subjects With Relapsed and/or Refractory Multiple...
Juno Therapeutics, Inc. Multiple Myeloma
This is an open-label, multicenter, Phase 1/2 study to determine the safety and efficacy of JCARH125, a CAR T-cell product that targets B-cell maturation antigen (BCMA), in adult subjects with relapsed and/or refractory multiple myeloma. The study will include a Phase 1 part... expand

This is an open-label, multicenter, Phase 1/2 study to determine the safety and efficacy of JCARH125, a CAR T-cell product that targets B-cell maturation antigen (BCMA), in adult subjects with relapsed and/or refractory multiple myeloma. The study will include a Phase 1 part to determine the recommended dose of JCARH125 in subjects with relapsed and/or refractory multiple myeloma, followed by a Phase 2 part to further evaluate the safety and efficacy of JCARH125 at the recommended dose.

Type: Interventional

Start Date: Feb 2018

open study

Brain Stimulation and Rehabilitation for Adults With Chronic, Severe Arm Motor Impairment After Stroke
University of Alabama at Birmingham Stroke Hemiplegia Hemiparesis
This pilot study will examine a combination therapy for adults with chronic, severe motor impairment of an arm after stroke. The intervention will combine brain stimulation with physical rehabilitation of the arm on the side of the body more-affected by stroke. expand

This pilot study will examine a combination therapy for adults with chronic, severe motor impairment of an arm after stroke. The intervention will combine brain stimulation with physical rehabilitation of the arm on the side of the body more-affected by stroke.

Type: Interventional

Start Date: Jun 2018

open study

An Artificial Intelligence Assisted Telehealth Intervention to Promote Self-Management in Patients With...
University of Alabama at Birmingham Diabetes Mellitus
This protocol involves a qualitative study of the needs/preferences of people with diabetes and health coaches regarding a telehealth coaching platform for glycemic control in people with diabetes. expand

This protocol involves a qualitative study of the needs/preferences of people with diabetes and health coaches regarding a telehealth coaching platform for glycemic control in people with diabetes.

Type: Observational

Start Date: Jul 2019

open study

Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Subjects With Major Depressive...
ACADIA Pharmaceuticals Inc. Adjunctive Treatment of Major Depressive Disorder
To evaluate the efficacy and safety of adjunctive pimavanserin compared to placebo in subjects with major depressive disorder who have an inadequate response to antidepressant therapy expand

To evaluate the efficacy and safety of adjunctive pimavanserin compared to placebo in subjects with major depressive disorder who have an inadequate response to antidepressant therapy

Type: Interventional

Start Date: Apr 2019

open study

Study of Efficacy of Ribociclib After Progression on CDK4/6 Inhibition in Patients With HR+ HER2- Advanced...
Kevin Kalinsky Metastatic Breast Cancer Breast Carcinoma
This is a randomized trial for patients with metastatic hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have progressed on an aromatase inhibitor plus a CDK4/6 inhibitor (either palbociclib or ribociclib) to either fulvestrant... expand

This is a randomized trial for patients with metastatic hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have progressed on an aromatase inhibitor plus a CDK4/6 inhibitor (either palbociclib or ribociclib) to either fulvestrant alone or fulvestrant with ribociclib (LEE-011). The purpose of the trial is to determine whether there is continued benefit for patients to remain on a CDK4/6 inhibitor at the time of switching anti-estrogen therapy. As ribociclib and palbociclib have a similar toxicity and drug profile and mechanism of action, we feel that it is appropriate for patients to receive either drug with an aromatase inhibitor prior to randomization.

Type: Interventional

Start Date: Mar 2016

open study

Endocrine Response in Women With Invasive Lobular Breast Cancer
Priscilla McAuliffe Breast Cancer
RATIONALE: Currently, adjuvant endocrine therapy often follows a "one-size-fits- all" approach, with most premenopausal women receiving tamoxifen, and most postmenopausal receiving aromatase inhibitor therapy. In current clinical practice, patients with invasive lobular carcinoma... expand

RATIONALE: Currently, adjuvant endocrine therapy often follows a "one-size-fits- all" approach, with most premenopausal women receiving tamoxifen, and most postmenopausal receiving aromatase inhibitor therapy. In current clinical practice, patients with invasive lobular carcinoma are treated no differently than patients with invasive ductal carcinoma based on the void of information specific to patients with this tumor type. Identification of a biological signal of tamoxifen and/or AI-resistance and/or fulvestrant-sensitivity in ILC patients would have dramatic implications for the future management of this breast cancer subtype. PURPOSE: To study whether fulvestrant is more effective than anastrozole or tamoxifen in reducing Ki67 in ILC and whether that Ki67 reduction will correlate with alterations in expression of ER and ER-regulated genes. Differential Ki67 effect in this study will serve as a surrogate for outcome of ILC patients on endocrine therapy. Primary Objective: To determine the change from baseline to post-treatment Ki67 values in ER-positive, HER2-negative ILC tissue derived from postmenopausal women awaiting definitive surgery or further neoadjuvant treatment who are randomized to 21-24 days of neoadjuvant endocrine treatments with fulvestrant (two 250 mg IM injections given on day 1), anastrozole (1mg given orally daily), or tamoxifen (20mg given orally daily).

Type: Interventional

Start Date: Aug 2015

open study

Omega-3 Replacement With Krill Oil in Disease Management of SLE
Aker Biomarine Antarctic AS Systemic Lupus Erythematosus (SLE)
A randomized, double-blind controlled, multicenter study in SLE patients given AKBM-3031or placebo for 24 weeks (randomized period) and followed by an open label extension (OLE) treatment with AKBM-3031 for the next 24 weeks. Patients will be maintained on stable doses of background... expand

A randomized, double-blind controlled, multicenter study in SLE patients given AKBM-3031or placebo for 24 weeks (randomized period) and followed by an open label extension (OLE) treatment with AKBM-3031 for the next 24 weeks. Patients will be maintained on stable doses of background medications, except for glucocorticoids. Decreases in doses of glucocorticoids will be encouraged during the first 20 weeks of both the randomized and open label extension portions of the trial. Stable doses of glucocorticoids and other background medications are required during weeks 20-22 and 44-48.If indicated by the PI, brief increases in corticosteroids are permitted during the first 20 weeks of both the blinded and open label extension portion of the trial. The increase in prednisone (or equivalent) dose is limited to 2X the back-ground level to a maximum of20 mg/day for a maximum of 1 week (7 days) or to a single administration of intravenous methylprednisolone or equivalent at a maximum dose of 500mg. Stable doses of glucocorticoids and other background medications are required during weeks 20-22 and 44-48

Type: Interventional

Start Date: Oct 2018

open study

The Topic Trial - Study to Determine the Safety and Efficacy of Ivacaftor
University of Alabama at Birmingham Chronic Obstructive Pulmonary Disease Chronic Bronchitis
The study is a Phase 2 Study to establish the safety and efficacy of a drug called Ivacaftor (VX-770) in patients with chronic obstructive pulmonary disease (COPD), chronic bronchitis, and acquired CFTR dysfunction as detected by sweat chloride analysis. The design is a pilot,... expand

The study is a Phase 2 Study to establish the safety and efficacy of a drug called Ivacaftor (VX-770) in patients with chronic obstructive pulmonary disease (COPD), chronic bronchitis, and acquired CFTR dysfunction as detected by sweat chloride analysis. The design is a pilot, randomized (3:1, active:placebo), double-blind, placebo-controlled study. Approximately 40 subjects with COPD will be randomized.

Type: Interventional

Start Date: Mar 2017

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

Dextromethorphan in Fibromyalgia
University of Alabama at Birmingham Fibromyalgia
The objective of this protocol is to evaluate if Dextromethorphan (DXM) reduces Fibromyalgia (FM) pain. DXM is a drug found in several over-the-counter products, including cough suppressants. The drug may reduce FM pain by suppressing inflammation in the central nervous system.... expand

The objective of this protocol is to evaluate if Dextromethorphan (DXM) reduces Fibromyalgia (FM) pain. DXM is a drug found in several over-the-counter products, including cough suppressants. The drug may reduce FM pain by suppressing inflammation in the central nervous system. The investigators will be observing the effects of DXM on daily self-reported pain measures in people with FM. If DXM reduces FM pain, it will provide important information about the nature of FM pathophysiology.

Type: Interventional

Start Date: Jun 2018

open study

Physical Activity Daily - An Internet-Based Walking Program for Patients With Peripheral Arterial Disease
University of Alabama at Birmingham Peripheral Arterial Disease
With the aging of the American population, the numbers of adults with peripheral arterial disease (PAD) will increase significantly over the next several decades. Patients with PAD are at increased risk for morbidity and mortality including both cardiovascular and all-cause mortality.... expand

With the aging of the American population, the numbers of adults with peripheral arterial disease (PAD) will increase significantly over the next several decades. Patients with PAD are at increased risk for morbidity and mortality including both cardiovascular and all-cause mortality. While regular physical activity reduces risk for vascular events and is recommended for treatment of PAD patients, few patients meet recommended goals. Exercise programs which increase long-term adherence to walking can be an important contribution to PAD treatment. Our Internet-based intervention, with an online community builds on a walking enhancement program developed by members of our team and is shown to improve adherence among patients with vascular disease such as coronary artery disease (CAD). Using a randomized, controlled trial study design, we propose to test an automated Internet-based walking program with a social media component, to improve long-term adherence to walking while increasing walking distance, and health-related quality of life, among patients with PAD. Participants will be randomized to 1 of four study groups: 1) weekly telephone counseling, 2) an Internet-based walking program, 3) a combination of telephone counseling and Internet-based walking program, or 4) a usual care group. The Internet-based walking program with a social media component has been shown to increase both adherence to walking and overall walking duration in populations with chronic complex conditions such as CAD and diabetes. There is a strong need to develop interventions, easily generalizable to a real-world population, to improve the reach of lifestyle interventions which result in improved physical function and adherence to regular exercise among complex medical patients. Patients such as those with PAD (a CAD risk equivalent) stand to benefit the most from such programs.

Type: Interventional

Start Date: Sep 2014

open study

RETHINC: REdefining THerapy In Early COPD for the Pulmonary Trials Cooperative
University of Michigan COPD (Chronic Obstructive Pulmonary Disease)
The study hypothesis is that symptomatic current and former smokers with spirometric values within the normal range (post-bronchodilator FEV1/FVC≥0.70 and post-BD FVC ≥ 70% predicted will still derive symptomatic benefit from long-acting bronchodilator therapy even though they... expand

The study hypothesis is that symptomatic current and former smokers with spirometric values within the normal range (post-bronchodilator FEV1/FVC≥0.70 and post-BD FVC ≥ 70% predicted will still derive symptomatic benefit from long-acting bronchodilator therapy even though they are excluded from current GOLD guideline recommendations.

Type: Interventional

Start Date: Aug 2017

open study

Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions...
W.L.Gore & Associates Aortic Aneurysm, Thoracic Aorta, Lesion
The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta. expand

The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta.

Type: Interventional

Start Date: Aug 2016

open study

A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole...
Pfizer Breast Cancer
This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have a dose escalation to identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib/fulvestrant and gedatolisib plus palbociclib/letrozole and expansion... expand

This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have a dose escalation to identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib/fulvestrant and gedatolisib plus palbociclib/letrozole and expansion to estimate the objective response rate (OR) of the combination of gedatolisib plus palbociclib/letrozole or palbociclib/fulvestrant.

Type: Interventional

Start Date: Jun 2016

open study

Early Integrated Telehealth Versus In-Person Palliative Care for Patients With Lung Cancer
Massachusetts General Hospital Lung Cancer
This research study is evaluating ways to provide palliative care to patients who have recently been diagnosed with lung cancer and their families. expand

This research study is evaluating ways to provide palliative care to patients who have recently been diagnosed with lung cancer and their families.

Type: Interventional

Start Date: Jun 2018

open study

To Compare Two Commonly Used Soft Tissue Grafting Techniques to Achieve Coronal Flap Advancement and...
University of Alabama at Birmingham Gingival Recession
This study will compare two incision designs to allow for coronal gingival/mucosal flap advancement and tissue augmentation with acellular dermal matrix (ADM) graft around teeth with gingival recession and a lack of adequate keratinized gingiva. To the investigators knowledge,... expand

This study will compare two incision designs to allow for coronal gingival/mucosal flap advancement and tissue augmentation with acellular dermal matrix (ADM) graft around teeth with gingival recession and a lack of adequate keratinized gingiva. To the investigators knowledge, these two techniques have not been compared for differences in clinical (amount of root coverage, tissue thickness, and esthetics) and patient-centered outcomes (pain, swelling, change in daily activities) in a controlled study.

Type: Interventional

Start Date: Apr 2019

open study

Advancing Research and Treatment for Frontotemporal Lobar Degeneration (ARTFL)
University of California, San Francisco FTLD Progressive Supranuclear Palsy (PSP) Frontotemporal Dementia (FTD) Corticobasal Degeneration (CBD) PPA Syndrome
Frontotemporal Lobar Degeneration (FTLD) is the neuropathological term for a collection of rare neurodegenerative diseases that correspond to four main overlapping clinical syndromes: frontotemporal dementia (FTD), primary progressive aphasia (PPA), corticobasal degeneration... expand

Frontotemporal Lobar Degeneration (FTLD) is the neuropathological term for a collection of rare neurodegenerative diseases that correspond to four main overlapping clinical syndromes: frontotemporal dementia (FTD), primary progressive aphasia (PPA), corticobasal degeneration syndrome (CBS) and progressive supranuclear palsy syndrome (PSPS). The goal of this study is to build a FTLD clinical research consortium to support the development of FTLD therapies for new clinical trials. The consortium, referred to as Advancing Research and Treatment for Frontotemporal Lobar Degeneration (ARTFL), will be headquartered at UCSF and will partner with six patient advocacy groups to manage the consortium. Participants will be evaluated at 14 clinical sites throughout North America and a genetics core will genotype all individuals for FTLD associated genes.

Type: Observational

Start Date: Sep 2014

open study

Neuroimaging Biomarker for Seizures
Providence VA Medical Center Seizure Disorder Seizure Disorder, Post Traumatic Traumatic Brain Injury Non-Epileptic Seizure Conversion Disorder
This multi-site study will examine patients with epilepsy (ES) following head injury [i.e., posttraumatic epilepsy (PTE)] and posttraumatic psychogenic Non-epileptic seizures (PNES) and will compare them to patients with traumatic brain injury (TBI) who do not have seizures using... expand

This multi-site study will examine patients with epilepsy (ES) following head injury [i.e., posttraumatic epilepsy (PTE)] and posttraumatic psychogenic Non-epileptic seizures (PNES) and will compare them to patients with traumatic brain injury (TBI) who do not have seizures using functional neuroimaging.

Type: Interventional

Start Date: Sep 2017

open study

Microtubule-Targeted Agent BAL101553 and Radiation Therapy in Treating Patients With Newly Diagnosed...
Basilea Pharmaceutica Glioblastoma MGMT-Unmethylated Glioblastoma
This phase I trial studies the side effects and best dose of microtubule-targeted agent BAL101553 when given together with radiation therapy in treating patients with newly diagnosed glioblastoma. Drugs used in chemotherapy, such as microtubule-targeted agent BAL101553, work... expand

This phase I trial studies the side effects and best dose of microtubule-targeted agent BAL101553 when given together with radiation therapy in treating patients with newly diagnosed glioblastoma. Drugs used in chemotherapy, such as microtubule-targeted agent BAL101553, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving microtubule-targeted agent BAL101553 and radiation therapy may work better in treating patients with glioblastoma.

Type: Interventional

Start Date: Jun 2017

open study

Evaluation of the Safety and Efficacy of TLD in Patients With COPD
Nuvaira, Inc. COPD
The purpose of this study is to confirm the safety and efficacy of the Nuvaira Lung Denervation System (Nuvaira System) in the treatment of COPD. expand

The purpose of this study is to confirm the safety and efficacy of the Nuvaira Lung Denervation System (Nuvaira System) in the treatment of COPD.

Type: Interventional

Start Date: May 2019

open study

Implementing the Decision-Aid for Lupus (IDEAL Strategy)
University of Alabama at Birmingham Systemic Lupus Erythematosus
The study will attempt to put into practice a shared decision making (SDM) strategy, using an individualized, computerized decision- aid (DA) for Systemic lupus erythematosus (SLE). expand

The study will attempt to put into practice a shared decision making (SDM) strategy, using an individualized, computerized decision- aid (DA) for Systemic lupus erythematosus (SLE).

Type: Observational

Start Date: Dec 2018

open study

Impact of CCR5 Blockade in HIV+ Kidney Transplant Recipients
National Institute of Allergy and Infectious Diseases (NIAID) HIV Infections Kidney Diseases
Maraviroc (MVC) is a type of HIV medicine called a CCR5 inhibitor. This study will evaluate the safety and tolerability of MVC in HIV-infected adults receiving a kidney transplant. expand

Maraviroc (MVC) is a type of HIV medicine called a CCR5 inhibitor. This study will evaluate the safety and tolerability of MVC in HIV-infected adults receiving a kidney transplant.

Type: Interventional

Start Date: Jan 2017

open study

Skeletal Health in Bariatric Surgery Patients
University of Alabama at Birmingham Bariatric Surgery Osteoporosis Fractures, Bone Roux En-Y Gastric Bypass Sleeve Gastrectomy
The investigators propose a prospective cohort trial that will help to understand the impact of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) in pre- and post-menopausal female bariatric patients. expand

The investigators propose a prospective cohort trial that will help to understand the impact of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) in pre- and post-menopausal female bariatric patients.

Type: Observational

Start Date: Mar 2018

open study

Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort
CHDI Foundation, Inc. Huntington's Disease
Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries—REGISTRY in Europe, and COHORT in North America and Australasia—while also expanding to include sites in Latin America. More than 20,000 participants... expand

Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries—REGISTRY in Europe, and COHORT in North America and Australasia—while also expanding to include sites in Latin America. More than 20,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org/for-researchers/access-data/ to learn more.

Type: Observational [Patient Registry]

Start Date: Jul 2012

open study

Harvoni Treatment Porphyria Cutanea Tarda
Wake Forest University Health Sciences Porphyria Cutanea Tarda Hepatitis C
In the medical literature there case reports that Harvoni improves symptoms in patients with PCT. However, this has never been systematically tested. Therefore, the purpose of this study is to assess whether Harvoni alone is an effective therapy of active PCT in patients with... expand

In the medical literature there case reports that Harvoni improves symptoms in patients with PCT. However, this has never been systematically tested. Therefore, the purpose of this study is to assess whether Harvoni alone is an effective therapy of active PCT in patients with Chronic Hepatitis C.

Type: Interventional

Start Date: Aug 2017

open study