We Partner 4 Research

Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) has been realized in informing the design of therapeutic trials in AD. ADNI3 continues the previously funded ADNI-1, ADNI-GO, and ADNI-2 studies that have been combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD). The overall goal of the study is to continue to discover, optimize, standardize, and validate clinical trial measures and biomarkers used in AD research.

Type: Observational

Start Date: Oct 2016

open study

Type 2 diabetes (DM2) affects nearly 20 million people in the United States while impaired glucose regulation (IGR), which includes impaired glucose tolerance (IGT), impaired fasting glucose (IFG), and early diabetes affects a considerably larger but unknown population group. At the current time there is no effective therapy to completely prevent, or reverse neuropathy associated with IGR and this represents a considerable challenge in rehabilitation. There is a particularly strong incentive to prevent IGT and related complications from advancing to DM2. IGR is a growing problem among all older adults and its strong association with many functional limitations, particularly mobility limitations, is not always recognized, even though diabetes-related disability occurs in up to 2/3 of older adults with diabetes and is associated with dependency, poor quality of life, and increased acute and long-term care utilization. Autonomic dysfunction is a significant problem in subjects with IGT. The Preliminary Data shows that over 90% of subjects with IGT have an abnormal score on questionnaires about autonomic symptoms such as lightheadedness, dry mouth or dry eyes, pale or blue feet, feet that are colder than the rest of the body, decreased sweating in the feet or increased sweating in the hands, nausea or bloating after eating, persistent diarrhea or constipation, or leaking of urine. In addition, patients with IGR have impaired balance control. These factors can increase the risk of falls in affected subjects. A non-randomized and non-controlled study showed that a diet and exercise intervention in patients with diabetes led to an overall improvement in autonomic function. Furthermore, it was shown that standing balance can be improved with a balance intervention program. However, there are no published studies that assess the effect of an intense physical activity intervention on autonomic function in IGR related neuropathy. This study will test an aerobic exercise and balance intervention in participants with IGR. The investigators will examine if an individually tailored, carefully monitored, Diet, Physical Activity, and Balance Enhancement Program (DPAEP) can improve autonomic function and balance control when compared to patients who receive standard care. Improving balance control and autonomic function can decrease the risk of falls and have a significant effect on the health of participants. The research is also significant because it will test subjects either before they become diabetic, or at an early stage in their diabetes, thus enhancing the chance of reversing the autonomic neuropathy or balance impairment. Furthermore, the study is designed to test whether improvement in autonomic function and balance is associated with improvement in clinical outcomes, quality of life, and the metabolic state of participants. Thus, the proposed interventions are likely to have a real life impact on participants and their health.

Type: Interventional

Start Date: Nov 2013

open study

The objective of this study is to examine whether messages conveying the harms and addictiveness of waterpipe (i.e., hookah) tobacco delivered by mobile phone multimedia messaging (MMS) are effective for promoting hookah tobacco cessation among young adults ages 18 to 30 years.

Type: Interventional

Start Date: Aug 2018

open study

Patients with type 1 diabetes type 1 (DM1) have increased risk of death due to heart disease and stroke. These cardiovascular conditions (CVD) are the leading cause of death in patients with DM1 younger than 40 years of age and up to 35% of all persons with DM1 will die before age 55 from CVD. Strategies are needed to help identify adolescents with DM1 at risk for CVD so that interventions to prevent heart disease and stroke can be undertaken.

Type: Observational

Start Date: Oct 2014

open study

The reason for this study is to see how effective and safe the study drug known as lasmiditan is in the acute treatment of 4 migraine attacks with or without aura.

Type: Interventional

Start Date: Jun 2019

open study

This is a multicenter, open label, single-arm, phase 3 study to assess the efficacy and safety of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of allogeneic hematopoietic cell transplant (HCT) after failure of rituximab.

Type: Interventional

Start Date: Dec 2017

open study

The purpose of this study is to explore the effectiveness Gulf War Health Education (GWHE) and iRest Yoga Nidra (meditation)/auricular (ear) acupuncture for Veterans with Gulf War Veterans' Illnesses (GWVI).

Type: Interventional

Start Date: May 2016

open study

Phase 3 efficacy and safety study to evaluate AG10 800 mg compared to placebo in subjects with symptomatic Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Type: Interventional

Start Date: Mar 2019

open study

This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4/6 inhibitor in combination with fulvestrant or an aromatase inhibitor (AI) .

Type: Interventional

Start Date: Nov 2018

open study

The objective of this study is to examine the effectiveness of a telehealth intervention intended to augment several factors related to brain health and cognition in Veterans with chronic multi-symptom illness.

Type: Interventional

Start Date: Nov 2017

open study

This study is for women in menopause with hot flashes. Menopause, a normal part of aging, is the time of a woman's last period. Hot flashes can interrupt a woman's daily life. The purpose of this study is to find out how safe it is for these women to take fezolinetant long term (up to 52 weeks). To do that, the study will look at the number and severity of the "adverse events." Those are the side effects that study participants have while they are in the study. The study treatments are fezolinetant low dose (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant high dose (2 tablets of fezolinetant) once a day or placebo (2 tablets) once a day. (Placebo is a dummy treatment that looks like medicine but does not have any medicine in it.) Women in this study will be picked for 1 of the 3 study treatments by chance alone. The study participants will take study treatment for 52 weeks. This study is "double-blinded." That means that the study participants and the study doctors do not know who takes which of the study treatments (fezolinetant low dose, fezolinetant high dose or placebo). At weeks 2 and 4 and then once a month, the study participants will go the hospital or clinic for a check-up. They will be asked about medications, side effects and how they feel. Other checks will include physical exam and vital signs (heart rate, temperature and blood pressure). Blood and urine will be collected for laboratory tests. At some study visits, study participants will complete questionnaires that are about their quality of life. At the first and last study visits, they will have a dual-energy x-ray absorptiometry (DXA for short) test done. To measure bone loss in the hips and spine, DXA creates pictures of the inside of these areas with low-dose x-rays. (The dose is approximately one-tenth of the amount of a normal chest x-ray.) Study participants who still have their uterus will have 2 more tests done at the first and last study visits. One of the 2 tests is endometrial biopsy. This test involves removing a small amount of tissue from the inside lining of the uterus. The tissue is then checked under a microscope. The other test is transvaginal ultrasound. It uses sound waves to create pictures of the organs in the pelvis. The sound waves are transmitted by a probe (transducer), which is placed inside the vagina. Study participants may have a screening mammogram done at the first and/or last study visit. A mammogram is an x-ray picture of the breasts used to screen for breast cancer. Study participants who did not have this test done in the last 12 months will have it done at the first study visit. They will have it done at the last study visit if they are due for their screening mammogram and their own doctor agrees. The last check-up at the hospital or clinic will be 3 weeks after the last dose of study treatment.

Type: Interventional

Start Date: Jul 2019

open study

A randomized placebo-controlled trial to evaluate the safety and efficacy of three doses of study drug LY3154207 treated for 12 weeks in participants with mild-to-moderate dementia associated with LBD (PDD or DLB).

Type: Interventional

Start Date: Nov 2017

open study

The study design is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries prior to stenting. Disrupt CAD III is being conducted as a staged pivotal study.

Type: Interventional

Start Date: Jan 2019

open study

This phase II trial studies how well MLN4924 (pevonedistat), carboplatin, and paclitaxel work in treating patients with stage IIIB or IV non-small cell lung cancer. Pevonedistat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pevonedistat together with carboplatin and paclitaxel may work better in treating patients with non-small cell lung cancer when compared with other standard chemotherapy drugs.

Type: Interventional

Start Date: Sep 2019

open study

This phase II trial studies how well nivolumab with or without ipilimumab works in treating patients with anal canal cancer that has not responded to previous treatment (refractory) and has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Type: Interventional

Start Date: May 2015

open study

The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas. Patients will receive anetumab ravtansine every three weeks in monotherapy for most indications. In cholangiocarinoma and adenocarinoma of the pancreas, 3-weekly anetumab ravtansine is administered in combination with cisplatin or gemcitabine respectively (both administered in a 2 week on / 1 week off schedule). Treatment will continue until disease progression or until another criterion for withdrawal is met. .Efficacy will be measured by evaluating the tumor's objective response rate. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses. Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue will also be collected for mesothelin expression testing and biomarker analyses.

Type: Interventional

Start Date: May 2017

open study

Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System.

Type: Interventional

Start Date: Dec 2017

open study

A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.

Type: Interventional

Start Date: Jun 2019

open study

The purpose of this trial is to assess whether the Total Posterior Spine System (TOPS System) is more effective than transforaminal lumbar interbody fusion (TLIF) when used to stabilize a single lumbar level (L2 - L5) following surgical decompression in patients diagnosed with (1) at least moderate lumbar spinal stenosis, and (2) Grade 1 spondylolisthesis (or retrolisthesis), and (3) thickening of the ligamentum flavum or scarring of the facet joint capsule. Success will be assessed by means of a composite endpoint that measures improvement in in patient reported outcomes and the absence of any major device related complications.

Type: Interventional

Start Date: Jan 2017

open study

This study will be conducted in two parts: Part 1 will be conducted using a Dose Escalation and Expansion design. The Part 1 Dose Escalation Phase of this study will identify a safe and tolerable dose to be further evaluated in the Part 1 Dose Expansion phase. Part 2 of the study will be conducted in parallel with the Part 1 Dose Expansion Phase and will evaluate the safety and efficacy of CMP-001 when administered as a monotherapy.

Type: Interventional

Start Date: Mar 2016

open study

A global, randomized phase III study to evaluate perioperative pembrolizumab with radical cystectomy + pelvic lymph node dissection (RC+PLND) versus RC+PLND alone in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC).

Type: Interventional

Start Date: Jul 2019

open study

The main objective is to assess long term safety of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).

Type: Interventional

Start Date: Nov 2017

open study

A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) as measured by overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of INC280.

Type: Interventional

Start Date: Jun 2015

open study

Medtronic is sponsoring the HeartWare™ HVAD™ Destination Therapy (DT) Post Approval Study (PAS) to further confirm safety and effectiveness of the HeartWare Ventricular Assist Device System (HVAD System) when used as intended, in "real-world" clinical practice. The Destination Therapy Post Approval Study (DT PAS) is conducted within Medtronic's Product Surveillance Platform.

Type: Observational [Patient Registry]

Start Date: Oct 2018

open study

Background: - Rheumatoid arthritis (RA) is often treated with drugs known as tumor necrosis factor (TNF) inhibitors, that can help decrease joint pain and swelling and can even result in RA remission. However, TNF inhibitors may increase risk of serious infections or some types of cancer. - It is not clear if people whose RA has been in remission for a long time need to stay on the TNF inhibitor to remain in remission. If they can stop taking the TNF inhibitor without having their symptoms come back, they will be spared the side effects of these medicines. Some studies have shown that people can stay in remission after stopping a TNF inhibitor, but other studies have not confirmed it. Researchers want to see if people with RA in remission on a TNF inhibitor can stay in remission without this medicine. Also there may be a clinical, imaging (MRI, ultrasound), laboratory profile that will help to determine which patients remain in remission after stopping these drugs. Objectives: - To see whether RA remission can continue after discontinuing use of a TNF inhibitor. - To determine if clinical, imaging and immunological measurements can predict which participants will flare and which will remain in remission after discontinuing TNF inhibitor. Eligibility: -Individuals at least 18 years of age who have RA that is being controlled with TNF inhibitors. We plan to randomize 291 patients. Design: - The study has seven visits over about 2 years. Six visits occur in the first year of the study, about 12 weeks apart. The final study visit is 1 year after the end of the treatment phase. - At the first visit, participants will be screened with a physical exam and medical history. They will complete a questionnaire about their RA symptoms. A blood sample will be collected. They will continue to take their RA medicines during this time. - The second visit will repeat tests from the first visit. These tests will confirm that the RA is in remission. Imaging studies will be performed on the hands, wrists, feet, and their connected joints. After this visit, participants will stop taking their TNF inhibitors and will start to have injections of a study drug. This drug will be either the participant's original TNF inhibitor or a placebo. - There will be follow-up visits at weeks 12, 24, and 36. Participants will have a medical history and joint exam. They will also provide blood samples and answer questions about their RA symptoms. - At the sixth visit (week 48), participants will repeat the tests and imaging studies from the second visit. They will stop taking the study injections. - Continued RA treatment after this visit will be decided by the participant and his or her rheumatologist. Participants may take any recommended medicine, including the TNF inhibitor they had been taking before the study. They will also receive a questionnaire to complete at home and mail back before the final study visit. - At the final visit (week 100), participants will repeat the tests and imaging studies from the second and sixth visits.

Type: Interventional

Start Date: Jan 2013

open study