450 matching studies

Sponsor Condition of Interest
A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)
Alector Inc. Frontotemporal Dementia
A phase 3 double blind, placebo controlled study evaluating the efficacy and safety of AL001 in participants at risk for or with frontotemporal dementia due to heterozygous mutations in the progranulin gene. expand

A phase 3 double blind, placebo controlled study evaluating the efficacy and safety of AL001 in participants at risk for or with frontotemporal dementia due to heterozygous mutations in the progranulin gene.

Type: Interventional

Start Date: Jul 2020

open study

A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants...
Eli Lilly and Company Type 2 Diabetes Mellitus
The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk. expand

The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.

Type: Interventional

Start Date: May 2020

open study

Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study
ECOG-ACRIN Cancer Research Group Anal Basaloid Carcinoma Anal Canal Cloacogenic Carcinoma Anal Canal Squamous Cell Carcinoma Anal Margin Squamous Cell Carcinoma Stage I Anal Cancer AJCC v8
This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine,... expand

This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine, 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 chemotherapy with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type.

Type: Interventional

Start Date: Nov 2019

open study

A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and...
Madrigal Pharmaceuticals, Inc. NASH - Nonalcoholic Steatohepatitis
A double-blind placebo controlled randomized Phase 3 study to determine if 80 or 100 mg of MGL-3196 as compared with placebo resolves NASH on liver biopsy and prevents progression to cirrhosis and/or advanced liver disease expand

A double-blind placebo controlled randomized Phase 3 study to determine if 80 or 100 mg of MGL-3196 as compared with placebo resolves NASH on liver biopsy and prevents progression to cirrhosis and/or advanced liver disease

Type: Interventional

Start Date: Mar 2019

open study

Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive...
OBI Pharma, Inc Triple Negative Breast Cancer
The GLORIA study is a Phase III, randomized, open-label study to prospectively evaluate the efficacy and safety of adagloxad simolenin (OBI 822)/OBI-821 in the adjuvant treatment of patients with high risk, early stage Globo-H Positive TNBC. expand

The GLORIA study is a Phase III, randomized, open-label study to prospectively evaluate the efficacy and safety of adagloxad simolenin (OBI 822)/OBI-821 in the adjuvant treatment of patients with high risk, early stage Globo-H Positive TNBC.

Type: Interventional

Start Date: Dec 2018

open study

MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Vertos Medical, Inc. Lumbar Spinal Stenosis
This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control... expand

This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group of similar patients that have had a comparable procedure. This study will start with patients treated with a study procedure having an index date on or after January 1, 2017, and enrollment will continue until stopped by the sponsor.

Type: Observational

Start Date: Mar 2017

open study

Lenalidomide and Blinatumomab for the Treatment of Relapsed Non-Hodgkin Lymphoma
National Cancer Institute (NCI) Recurrent B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma Recurrent Burkitt Lymphoma Recurrent Diffuse Large B-Cell Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma
This phase I trial studies the side effects and best dose of lenalidomide and blinatumomab when given together in treating patients with non-Hodgkin lymphoma that has returned after a period of improvement (relapsed). Biological therapies, such as lenalidomide, use substances... expand

This phase I trial studies the side effects and best dose of lenalidomide and blinatumomab when given together in treating patients with non-Hodgkin lymphoma that has returned after a period of improvement (relapsed). Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.

Type: Interventional

Start Date: Jun 2016

open study

KanSurvive: Testing a Model for Improving Cancer Survivorship Care in Rural Practice
University of Kansas Medical Center Breast Cancer Colorectal Cancer Lung Cancer Prostate Cancer
Approximately, 20 rural primary care practices to participate in a delayed intervention-controlled trial. Phase I: Formal and structured work flow evaluations to better identify specific gaps in processes of care while assessing what on-going training is needed for adoption... expand

Approximately, 20 rural primary care practices to participate in a delayed intervention-controlled trial. Phase I: Formal and structured work flow evaluations to better identify specific gaps in processes of care while assessing what on-going training is needed for adoption of high-quality cancer survivorship care in rural practice. These will be incorporated into the ECHO sessions (Aim 1). Phase II: Conduct and test the effectiveness of the novel KanSurvive-ECHO intervention (Aim2) and finally identify barriers and facilitators to implementation of KanSurvive-ECHO (Aim 3).

Type: Interventional

Start Date: Nov 2020

open study

Hyperpolarized 129Xe MRI of Survivors of COVID-19
University of Kansas Medical Center Covid19
The purpose of this study is to evaluate pulmonary function of patients recovering from mild, moderate, and severe COVID-19 disease using hyperpolarized 129Xe MRI. expand

The purpose of this study is to evaluate pulmonary function of patients recovering from mild, moderate, and severe COVID-19 disease using hyperpolarized 129Xe MRI.

Type: Interventional

Start Date: Feb 2021

open study

Immune Modulators for Treating COVID-19
Daniel Benjamin Covid19
ACTIV-1 IM is a master protocol designed to evaluate multiple investigational agents for the treatment of moderately or severely ill patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The research objectives are to evaluate each agent with... expand

ACTIV-1 IM is a master protocol designed to evaluate multiple investigational agents for the treatment of moderately or severely ill patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The research objectives are to evaluate each agent with respect to speed of recovery, mortality, illness severity, and hospital resource utilization. Each agent will be evaluated as add-on therapy to the standard of care (SoC) in use at the local clinics, including remdesivir (provided). The SoC may change during the course of the study based on other research findings. Comparisons of the agents among themselves is not a research objective. The study population corresponds to moderately and severely ill patients infected with the coronavirus disease 2019 (COVID-19) virus. Recruitment will target patients already hospitalized for treatment of COVID-19 infection as well as patients being treated for COVID-19 infection in Emergency Departments while waiting to be admitted to the hospital. Patients both in and out of the ICU are included in the study population.

Type: Interventional

Start Date: Oct 2020

open study

A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Participants...
Hoffmann-La Roche Multiple Sclerosis, Primary Progressive
A study to evaluate the efficacy and safety of fenebrutinib on disability progression in adult participants with Primary Progressive Multiple Sclerosis (PPMS). All eligible participants will be randomized 1:1 to either daily oral fenebrutinib (or placebo) or intravenous (IV)... expand

A study to evaluate the efficacy and safety of fenebrutinib on disability progression in adult participants with Primary Progressive Multiple Sclerosis (PPMS). All eligible participants will be randomized 1:1 to either daily oral fenebrutinib (or placebo) or intravenous (IV) ocrelizumab (or placebo) in a blinded fashion through an interactive voice or web-based response system (IxRS). Approximately 946 participants will be enrolled and will be recruited globally. Participants who discontinue study medication early or discontinue from the study will not be replaced. The Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.

Type: Interventional

Start Date: Oct 2020

open study

Study to Evaluate the Safety and Pharmacokinetics of UTTR1147A in Combination With Standard of Care in...
Genentech, Inc. Acute Graft-versus-host Disease
This is a Phase Ib, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of UTTR1147A and to make a preliminary assessment of activity of UTTR1147A in combination with standard-of-care (SOC) in the prevention of acute graft-versus-host... expand

This is a Phase Ib, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of UTTR1147A and to make a preliminary assessment of activity of UTTR1147A in combination with standard-of-care (SOC) in the prevention of acute graft-versus-host disease (aGVHD) in participants undergoing allogeneic hematopoietic stem cell transplantation (HSCT).

Type: Interventional

Start Date: Nov 2020

open study

Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and...
Merck Sharp & Dohme Corp. Squamous Cell Carcinoma of Head and Neck
This study is designed to assess the safety and efficacy of lenvatinib in combination with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck... expand

This study is designed to assess the safety and efficacy of lenvatinib in combination with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and a programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor. The primary hypothesis is that pembrolizumab + lenvatinib is superior to SOC chemotherapy with respect to ORR per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review.

Type: Interventional

Start Date: Aug 2020

open study

A Study of CART-PSMA-TGFβRDN in Patients With Metastatic Castration Resistant Prostate Cancer
Tmunity Therapeutics Metastatic Castration-resistant Prostate Cancer
Multi-center, open-label, Phase 1 study of the safety, tolerability and feasibility of dosing patients harboring metastatic castration resistant prostate cancer (mCRPC) with genetically modified autologous T cells (CART-PSMA-TGFβRDN cells) engineered to express a chimeric... expand

Multi-center, open-label, Phase 1 study of the safety, tolerability and feasibility of dosing patients harboring metastatic castration resistant prostate cancer (mCRPC) with genetically modified autologous T cells (CART-PSMA-TGFβRDN cells) engineered to express a chimeric antigen receptor (CAR) capable of recognizing the tumor antigen prostate-specific membrane antigen (PSMA) and activating the T cell.

Type: Interventional

Start Date: Nov 2019

open study

A Study to Evaluate Enfortumab Vedotin in Subjects With Previously Treated Locally Advanced or Metastatic...
Astellas Pharma Global Development, Inc. Locally Advanced or Metastatic Malignant Solid Tumors
The primary purpose of this study is to determine the antitumor activity of enfortumab vedotin as measured by confirmed objective response rate (ORR). This study will also assess other measures of antitumor activity; overall survival (OS); as well as the safety and tolerability... expand

The primary purpose of this study is to determine the antitumor activity of enfortumab vedotin as measured by confirmed objective response rate (ORR). This study will also assess other measures of antitumor activity; overall survival (OS); as well as the safety and tolerability of enfortumab vedotin.

Type: Interventional

Start Date: Mar 2020

open study

To Compare Artificial Intelligence Software Aided Adenoma Detection in Screening Colonoscopies Versus...
Docbot, Inc. Colorectal Adenoma Colorectal Polyp Colorectal Adenocarcinoma Colorectal SSA
The aim of this study is to assess the efficacy of Ultivision Artificial Intelligence (AI) Software in detecting adenomas in screening colonoscopy procedures. The safety of Ultivision AI Software will also be assessed. A subset of the subjects will enter a roll-in period for... expand

The aim of this study is to assess the efficacy of Ultivision Artificial Intelligence (AI) Software in detecting adenomas in screening colonoscopy procedures. The safety of Ultivision AI Software will also be assessed. A subset of the subjects will enter a roll-in period for clinical trial safety assessment. The remainder of subjects who are eligible will enter the detection phase which comprises a screening colonoscopy procedure. In the detection phase, subjects will be randomized to a screening colonoscopy with Ultivision AI Software enhancement or without AI Software enhancement. The study will measure the mean adenomas per colonoscopy procedure, as defined by the protocol, detected while receiving either treatment option.

Type: Interventional

Start Date: Jun 2020

open study

Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study...
International Spine Study Group Foundation Cervical Deformity
Multi-center, prospective, non-randomized study to evaluate outcomes of surgically treated patients with adult cervical spinal deformity. expand

Multi-center, prospective, non-randomized study to evaluate outcomes of surgically treated patients with adult cervical spinal deformity.

Type: Observational

Start Date: Aug 2019

open study

A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease
Neuraly, Inc. Parkinson Disease
This is a phase 2 study designed to assess the safety, tolerability and efficacy of NLY01 in subjects with early untreated Parkinson's disease (PD). Evidence suggests NLY01, a pegylated form of exenatide, may be beneficial in PD and is being developed as a potential treatment... expand

This is a phase 2 study designed to assess the safety, tolerability and efficacy of NLY01 in subjects with early untreated Parkinson's disease (PD). Evidence suggests NLY01, a pegylated form of exenatide, may be beneficial in PD and is being developed as a potential treatment for neurodegenerative disorders. For more information, please visit: www.PrismPDstudy.com

Type: Interventional

Start Date: Feb 2020

open study

Testing the Addition of the Drugs, Apalutamide and Abiraterone Acetate With Prednisone, to the Usual...
NRG Oncology Positive Lymph Node Prostate Adenocarcinoma PSA Level Greater Than Zero Stage I Prostate Cancer AJCC v8 Stage II Prostate Cancer AJCC v8
This phase III trial studies how well adding apalutamide, abiraterone acetate, and prednisone to the usual hormone therapy and radiation therapy works compared to the usual hormone therapy and radiation therapy in treating patients with node-positive prostate cancer after... expand

This phase III trial studies how well adding apalutamide, abiraterone acetate, and prednisone to the usual hormone therapy and radiation therapy works compared to the usual hormone therapy and radiation therapy in treating patients with node-positive prostate cancer after surgery. Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male sex hormones, can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may help stop or slow the growth of prostate cancer cell growth by blocking the androgens. Abiraterone acetate blocks some of the enzymes needed for androgen production and may cause the death of prostate cancer cells that need androgens to grow. Prednisone may help abiraterone acetate work better by making tumor cells more sensitive to the drug. Adding apalutamide and abiraterone acetate with prednisone to the usual usual hormone therapy and radiation therapy after surgery may stabilize prostate cancer and prevent it from spreading or extend time without disease spreading compared to the usual approach.

Type: Interventional

Start Date: Mar 2020

open study

Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis
Ra Pharmaceuticals Myasthenia Gravis, Generalized
The RAISE study is a multicenter, randomized, double-blind, placebo controlled study to confirm the efficacy, safety, and tolerability of zilucoplan in subjects with generalized Myasthenia Gravis. Subjects will be randomized in a 1:1 ratio to receive daily SC doses of 0.3... expand

The RAISE study is a multicenter, randomized, double-blind, placebo controlled study to confirm the efficacy, safety, and tolerability of zilucoplan in subjects with generalized Myasthenia Gravis. Subjects will be randomized in a 1:1 ratio to receive daily SC doses of 0.3 mg/kg zilucoplan or placebo for 12 weeks.

Type: Interventional

Start Date: Oct 2019

open study

Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
SQZ Biotechnologies Adult Solid Tumor
This is a Phase 1 open-label, multicenter study of the safety and tolerability, immunogenic effects, antitumor activity, and pharmacodynamics of SQZ-PBMC-HPV as monotherapy and in combination with atezolizumab in HLA-A*02+ patients with recurrent, locally advanced or metastatic... expand

This is a Phase 1 open-label, multicenter study of the safety and tolerability, immunogenic effects, antitumor activity, and pharmacodynamics of SQZ-PBMC-HPV as monotherapy and in combination with atezolizumab in HLA-A*02+ patients with recurrent, locally advanced or metastatic human papillomavirus strain 16 positive (HPV16+) solid tumors. The study includes patients with anal, rectal, cervical, head and neck, penile, vulvar, or vaginal cancer.

Type: Interventional

Start Date: Jan 2020

open study

Radiation Medication (Radium-223 Dichloride) Versus Radium-223 Dichloride Plus Radiation Enhancing Medication...
National Cancer Institute (NCI) Castration-Resistant Prostate Carcinoma Metastatic Malignant Neoplasm in the Lymph Nodes Metastatic Prostate Carcinoma Stage IV Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8
This phase I/II trial studies the best dose of M3814 when given together with radium-223 dichloride or with radium-223 dichloride and avelumab and to see how well they work in treating patients with castrate-resistant prostate cancer that had spread to other places in the... expand

This phase I/II trial studies the best dose of M3814 when given together with radium-223 dichloride or with radium-223 dichloride and avelumab and to see how well they work in treating patients with castrate-resistant prostate cancer that had spread to other places in the body (metastatic). M3814 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radioactive drugs, such as radium-223 dichloride, may carry radiation directly to tumor cells and not harm normal cells. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study is being done to find out the better treatment between radium-223 dichloride alone, radium-223 dichloride in combination with M3814, or radium-223 dichloride in combination with both M3814 and avelumab, to lower the chance of prostate cancer growing or spreading in the bone, and if this approach is better or worse than the usual approach for advanced prostate cancer not responsive to hormonal therapy.

Type: Interventional

Start Date: Dec 2019

open study

Preventing Depression and Anxiety: A Cystic Fibrosis-Specific Cognitive Behavioral Therapy Intervention
Massachusetts General Hospital Depression Anxiety
Individuals with Cystic Fibrosis (CF) are at high risk for depression and anxiety, with negative consequences for quality of life, ability to carry out daily CF treatments, and health. CF Foundation and European CF Society guidelines recommend routine screening, treatment,... expand

Individuals with Cystic Fibrosis (CF) are at high risk for depression and anxiety, with negative consequences for quality of life, ability to carry out daily CF treatments, and health. CF Foundation and European CF Society guidelines recommend routine screening, treatment, and preventative efforts for depression and anxiety. Cognitive-behavioral therapy (CBT) interventions focused on teaching coping skills have a large evidence-base for prevention and treatment of depression and anxiety, but there are barriers to accessing these interventions for individuals with CF. Drs. Friedman and Georgiopoulos at Massachusetts General Hospital (MGH) have developed a CF-specific CBT-based preventive intervention for depression and anxiety with input from adults with CF and CF healthcare team members, called CF-CBT: A cognitive-behavioral skills-based program to promote emotional well-being for adults with CF, along with a training and supervision program for CF team interventionists. CF-CBT consists of 8 45-minute modules that can be flexibly delivered in the outpatient CF clinic, on the inpatient unit, or by telephone, by multidisciplinary members of the CF care team, minimizing additional cost and burden of care to patients. The goal of this study is to test CF-CBT in 60 adults screening in the mild range on measures of depression and anxiety at 4 CF centers, in a prospective randomized clinical trial comparing the intervention to usual treatment. Participants will be randomized to receive the CF-CBT intervention immediately, or to a 3-month waitlist control followed by intervention. The study will measure depression, anxiety, quality of life, stress, and coping self-efficacy before and after the CF-CBT intervention, and also 3 and 6 months post-intervention.

Type: Interventional

Start Date: Jul 2019

open study

A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With...
Seagen Inc. HER2-positive Breast Cancer
This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread... expand

This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.

Type: Interventional

Start Date: Oct 2019

open study

A Study to Test the Efficacy and Safety of Inhaled TD139 in Subjects With Idiopathic Pulmonary Fibrosis...
Galecto Biotech AB Idiopathic Pulmonary Fibrosis (IPF)
This is a randomized, double-blind, placebo-controlled phase 2b trial in subjects with IPF (idiopathic pulmonary fibrosis) investigating the efficacy and safety of TD139. expand

This is a randomized, double-blind, placebo-controlled phase 2b trial in subjects with IPF (idiopathic pulmonary fibrosis) investigating the efficacy and safety of TD139.

Type: Interventional

Start Date: Feb 2019

open study