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NCT ID: NCT03314181 Active, not recruiting - Multiple Myeloma Clinical Trials

A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Participants With Relapsed or Refractory Multiple Myeloma

Start date: April 2, 2018
Phase: Phase 2
Study type: Interventional

This is a study of venetoclax, daratumumab, and dexamethasone with and without bortezomib combination therapy to evaluate safety, tolerability, and efficacy of these combinations in participants with relapsed or refractory multiple myeloma. The study will consist of 3 distinct parts: Part 1 includes participants with t(11;14) positive relapsed/refractory (R/R) multiple myeloma who will receive venetoclax in combination with daratumumab and dexamethasone (VenDd); Part 2 includes participants with R/R multiple myeloma who will receive venetoclax in combination with daratumumab, bortezomib, and dexamethasone (VenDVd); Part 3 includes participants with t(11;14) positive R/R multiple myeloma who will receive venetoclax in combination with daratumumab and dexamethasone (VenDd) or daratumumab, bortezomib, and dexamethasone (DVd). Part 1 and Part 2 are non-randomized and will be initiated with a dose-escalation phase in which increasing doses of venetoclax will be given with fixed doses of daratumumab and dexamethasone (Part 1a) or with fixed doses of daratumumab, bortezomib, and dexamethasone (Part 2a). Each dose escalation phase will be followed by a single-arm, open-label expansion phase. Part 3 will include a randomized, open-label expansion phase with participants receiving venetoclax in combination with daratumumab and dexamethasone (VenDd) or daratumumab, bortezomib, and dexamethasone (DVd).

NCT ID: NCT03313960 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

A Randomized Controlled Trial Evaluating One Drop | Premium With Afrezza vs. One Drop | Premium Alone

Start date: October 5, 2017
Phase: Phase 4
Study type: Interventional

The A-One study is a prospective, randomized controlled trial evaluating the use of the One Drop | Premium 'On Track' in combination with Afrezza treatment on the glycemic control, treatment adherence, social-cognitive barriers to adherence, and treatment satisfaction of people with Type 2 diabetes (T2D) and a hemoglobin A1c (A1c) > 7.0% already prescribed an injectable rapid-acting insulin.

NCT ID: NCT03313804 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer

Priming Immunotherapy in Advanced Disease With Radiation

Start date: October 26, 2017
Phase: Phase 2
Study type: Interventional

This study proposes to treat metastatic non-small cell lung cancer (NSCLC) and head/neck squamous cell cancer (HNSCC) patients who are already initiating an immune checkpoint inhibitor (such as Nivolumab, Atezolizumab or Pembrolizumab) for disease treatment as per FDA approved guidelines. In these patients we will deliver a short-course radiation to a single systemic (non-CNS) site within 14 days of receiving the first dose of immune checkpoint inhibitors. This sequence allows radiation to release tumor antigens from immune inaccessible areas such as necrotic tumor or low perfusion to provide a robust anti-tumor immune response with immune checkpoint inhibitors. The primary objective is to assess six-month progression free survival (PFS) compared to historical control.

NCT ID: NCT03313362 Active, not recruiting - Clinical trials for Psychogenic Seizures

Detecting PNES With Single-channel sEMG

Start date: November 3, 2017
Phase: N/A
Study type: Interventional

This is a prospective, comparative, multicenter study of subjects being admitted for standard of care therapy in Epilepsy Monitoring Units in the Veteran's Affair (VA) Medical Centers.

NCT ID: NCT03312920 Active, not recruiting - Healthy Adults Clinical Trials

Investigating Memory Retrieval Improvement in Healthy Subjects

Start date: September 27, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate whether learning can be accelerated and associative memory performance improved in healthy subjects by applying transcranial Direct Current Stimulation (tDCS) during a Face Name memory task.

NCT ID: NCT03311958 Active, not recruiting - Clinical trials for Diffuse Large B Cell Lymphoma

Molecular Monitoring With Circulating Tumor DNA and Nivolumab Maintenance

Start date: May 15, 2018
Phase: Early Phase 1
Study type: Interventional

Patients suffering from diffuse large B-cell lymphoma (DLBCL) who relapse within 12 months of chemotherapy usually undergo salvage therapies, followed by autologous transplant with a low success rate. These treatments for relapse have significant toxicities and may not be tolerated well by the patients. These patients need an effective means of identifying relapse at an early time point to be treated effectively. Detection of circulating tumor DNA (ctDNA) has been reported to be a sensitive and more specific method to detect relapse at an early stage compared to PET/ CT scans. Purpose of this trial is to monitor patients who have undergone successful chemotherapy for the presence of ctDNA. Patients who test positive for ctDNA would be treated with Nivolumab for a period of 2 years to avoid complete relapse.

NCT ID: NCT03311503 Active, not recruiting - Gene Therapy Clinical Trials

Phase I/II Trial of Lentiviral Gene Transfer for SCID-X1 With Low Dose Targeted Busulfan Conditioning

Start date: January 19, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I/II open label multi-center study in which patients will receive low dose targeted busulfan followed by infusion of autologous CD34+ selected bone marrow or mobilized peripheral blood cells transduced with the G2SCID vector. Subjects will be enrolled over 3 years and be followed for 2 years post-infusion on this protocol, then followed long-term on a separate long-term follow-up protocol. Enrollment of subjects will be agreed upon by representatives of both sites. Data will be collected uniformly from both sites through an electronic capture system and key laboratory studies will be centralized. Harvest, cellular manufacturing and infusion will occur at each site using the same SOPs. Key aspects of cellular product characterization will be centralized

NCT ID: NCT03311061 Active, not recruiting - Teen Pregnancy Clinical Trials

Evaluation of Curriculum for Teen Pregnancy Prevention: Decisions, Responsibility, Empowerment, Accountability, Motivations & Success

DREAMS
Start date: October 10, 2017
Phase: N/A
Study type: Interventional

The study is a an evaluation of the teen pregnancy prevention curriculum Decisions, Responsibility, Empowerment, Accountability, Motivations & Success (DREAMS) through a random control trial. The evaluation will take place in high schools in the greater Houston area. Five cohorts of two classes each in ten HS schools will be used. Randomization will occur each semester for five semesters. Curriculum is ten modules in length delivered in 45 minute classes twice a week for five weeks.

NCT ID: NCT03310983 Active, not recruiting - Clinical trials for Pregnancy; Nutritional Diseases

Growth and Adiposity in Newborns: The Influence of Prenatal Docosahexaenoic Acid (DHA) Supplementation

ADORE-GAINS
Start date: November 1, 2017
Phase:
Study type: Observational

The purpose of this study is to learn if participants in the ADORE study (NCT02626299), who took a DHA supplement during pregnancy, see favorable body fat in their infants from birth to 24 months, and if excessive or appropriate weight gain during pregnancy impacts this result.

NCT ID: NCT03310957 Active, not recruiting - Clinical trials for Triple Negative Breast Neoplasms

Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer

Start date: February 27, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This trial studies ladiratuzumab vedotin (LV) with pembrolizumab in patients with triple-negative breast cancer. It will find out what side effects happen when participants get these two drugs. A side effect is anything the drugs do besides treating cancer. Pembrolizumab is a drug that can be used to treat triple-negative breast cancer. The trial will also find out if these drugs work to treat this type of cancer. Participants in this study have metastatic breast cancer. This means the cancer has spread to other parts of the body.