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NCT ID: NCT03689699 Active, not recruiting - Prostate Cancer Clinical Trials

Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8)

Start date: October 11, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

MAGIC-8 is a two-arm, multicenter, phase 1b/2 study to assess the efficacy of immunotherapy with either Nivolumab (anti-PD-1) or Nivolumab plus BMS-986253 combined with ADT using Degarelix (LHRH antagonist) for men with hormone-sensitive prostate cancer and a rising prostate-specific antigen (PSA). The purpose of this study is to see whether immunotherapy with either Nivolumab alone or Nivolumab plus BMS-986253 combined with Degarelix, which suppresses testosterone, is safe and can decrease the chance that the cancer will come back. The primary objectives are to 1) determine the rate of PSA recurrence defined as a PSA >0.2ng/ml for radical prostatectomy patients or PSA >2.0ng/ml for patients who received primary radiation therapy at a time point of 10 months after start of therapy; and 2) determine the safety and tolerability of either nivolumab or nivolumab plus BMS-986253 in combination with degarelix in men with hormone-sensitive prostate cancer. The secondary objectives include determining relapse-free survival (RFS) and % change in PSA to immunotherapy alone.

NCT ID: NCT03688763 Active, not recruiting - Insomnia Clinical Trials

A Pilot Study of Digital Cognitive Behavioral Therapy for Veterans

Start date: February 5, 2018
Phase: N/A
Study type: Interventional

The proposed study is a multiple baseline design pilot study which seeks to evaluate the impact of digitally administered CBT-I, using the Sleepio platform, for the treatment of insomnia disorder among Veterans with co-morbid psychopathology. In addition, information related to acceptability and feasibility of the intervention among a Veteran sample will be obtained.

NCT ID: NCT03688503 Active, not recruiting - Blood Pressure Clinical Trials

Magnesium Supplementation and Blood Pressure Reduction

Start date: February 15, 2019
Phase: N/A
Study type: Interventional

This double-blind, placebo-controlled randomized clinical trial will test whether a magnesium glycinate supplement (480 mg/day) taken for 12 weeks lowers blood pressure.

NCT ID: NCT03688451 Active, not recruiting - Clinical trials for Non Hodgkin Lymphoma

Intrathecal Rituximab With Standard Intrathecal Prophylaxis to Prevent CNS Relapse for CD 20+ Non Hodgkin Lymphoma

Start date: October 29, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to learn if giving rituximab, the study drug, right into the spinal canal along with chemotherapy drugs like methotrexate is possible and safe.

NCT ID: NCT03688386 Active, not recruiting - Clinical trials for Language Development

A Language Intervention Study of Preterm Infants

Start date: December 4, 2018
Phase: N/A
Study type: Interventional

This is a randomized controlled trial to study a reading intervention in the NICU among preterm infants using LENA (Language Environment Analysis) recordings, linguistic feedback, and a language curriculum to improve the neonatal inpatient language environment and language outcomes for preterm infants.

NCT ID: NCT03688243 Active, not recruiting - Clinical trials for Dry Macular Degeneration

Non Exudative AMD Imaged With SS-OCT

BIRC-01
Start date: January 18, 2018
Phase:
Study type: Observational

The investigators wish to better understand the role of the choriocapillaris (CC) in the formation and progression of non-exudative in age related macular degeneration (armd) by imaging the retinal pigment epithelium (rpe) and the choroidal microvasculature and by studying their inter-dependence to determine if the loss of the CC could prove useful as an anatomic clinical trial endpoint in future drug trials.

NCT ID: NCT03688178 Active, not recruiting - Glioblastoma Clinical Trials

DC Migration Study to Evaluate TReg Depletion In GBM Patients With and Without Varlilumab

DERIVe
Start date: August 26, 2020
Phase: Phase 2
Study type: Interventional

Patients with newly diagnosed glioblastoma will be consented following tumor resection then undergo leukapheresis for harvest of peripheral blood leukocytes for generation of dendritic cells. Subjects will then receive standard of care (planned 6 weeks) radiation therapy (RT) and concurrent temozolomide (TMZ) at a standard targeted dose of 75 mg/m2/day. The study cycle of TMZ comprises a targeted dose of 150-200mg/m2/day for 5 days every 4 (+2) weeks for up to 12 cycles (patients with unmethylated MGMT gene promoter will receive only cycle 1). All patients will receive up to a total of 10 DC vaccines called pp65 CMV dendritic cells (DC). Dendritic Cell (DC) vaccines #1-3 will be given every two weeks, thus delaying the initiation of TMZ cycle 2 for patients receiving TMZ. All remaining TMZ/vaccine cycles will be 4 (+2) weeks in length. After the first 3 DC vaccines given during Cycle 1 of TMZ, the remaining DC vaccine injections are given on Day 21 (+/- 2 days) of each TMZ cycle. Subjects with unmethylated MGMT will only receive one cycle of adjuvant TMZ; however, their vaccine schedule will follow the same 4 (+ 2) week TMZ cycle schedule. Following RT, patients will be randomized into 1 of 3 groups. Groups 1 and 2 will be blinded. The groups differ in the type of pre-conditioning received prior to DC vaccine #4; additionally, Group 3 will be receiving infusions of varlilumab 7 days prior to and with vaccine #1 and 7 days prior to vaccine #3+. The pre-conditioning for each group is as follows: Group 1: Unpulsed DC pre-conditioning prior to DC vaccine #4; Group 2: Tetanus-diphtheria (Td) pre-conditioning prior to DC vaccine #4; Group 3: Td pre-conditioning prior to DC vaccine #4 and varlilumab infusion at 7 days prior to each DC vaccine (except DC vaccine #2) with Td pre-conditioning prior to vaccine #4.

NCT ID: NCT03688126 Active, not recruiting - Alzheimer Disease Clinical Trials

U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk

POINTER
Start date: January 8, 2019
Phase: N/A
Study type: Interventional

The purpose of this research study is to see if lifestyle changes can protect memory and thinking (cognition) as we age. A recent study in Finland found that a combination of physical and cognitive exercise, diet, and social activity protected cognitive function in healthy older adults who were at increased risk of significant memory loss. So far no medications can rival this positive outcome. The point of POINTER is to test if lifestyle change can also protect against memory loss in Americans.

NCT ID: NCT03687710 Active, not recruiting - Alzheimer Disease Clinical Trials

The Comparative Effectiveness Dementia & Alzheimer's Registry

CEDAR
Start date: February 16, 2015
Phase:
Study type: Observational [Patient Registry]

To evaluate the effectiveness of using clinical precision medicine to develop lifecourse interventions for Alzheimer's disease (AD) prevention and treatment. Anthropometrics, blood biomarkers (including genetics), and cognition will measured longitudinally to assess the comparative effectiveness of clinical care.

NCT ID: NCT03687593 Active, not recruiting - Clinical trials for Total Knee Arthroplasty

Safety and Performance Using Legion™ CR Oxinium and CoCr Femoral Implants Combined With Legion™/Genesis™ II XLPE High Flex Tibial Inserts

Legion Oxinium
Start date: August 26, 2018
Phase:
Study type: Observational

The purpose of this research is to collect data on patients that had the Legion CR Oxinium and CoCr Femoral Implant and the Legion/Genesis II XLPE High Flex Tibial Inserts implanted in the past. Smith & Nephew will evaluate the safety and performance of these implants.