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NCT ID: NCT03430791 Terminated - Clinical trials for Recurrent Glioblastoma

Trial of Combination Tumor Treating Fields (TTF; Optune), Nivolumab Plus/Minus Ipilimumab for Recurrent Glioblastoma

Start date: December 5, 2018
Phase: Phase 2
Study type: Interventional

Phase I/II trial in which participants with recurrent glioblastoma will receive a combination of tumor treating fields(portable device), nivolumab with or without ipilimumab.

NCT ID: NCT03430544 Terminated - Clinical trials for Cocaine Use Disorder

Cariprazine Effects on Brain and Behavior in Cocaine Use Disorder

Start date: April 4, 2018
Phase: Phase 2
Study type: Interventional

This is a phase II, randomized, single-blind, placebo-controlled study to examine whether cariprazine (1.5 or 3 mg/d) 1) alters brain and/or behavioral responses to probes of reward and inhibition and 2) decreases cocaine use in individuals with cocaine use disorder. Subjects will be tested as inpatients during fMRI sessions. After the 2-week inpatient/medication induction phase, study medication will continue for 8 outpatient weeks, during which time cocaine use will be tracked. Subjects will be monitored during a 4-wk followup phase thereafter.

NCT ID: NCT03430531 Terminated - Clinical trials for Post-Dural Puncture Headache

Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache

Start date: May 31, 2019
Phase: Phase 2
Study type: Interventional

The objective of the study is to determine the effectiveness of Spheno-Palatine (SP) ganglion block to alleviate the pain of post-dural puncture headache (PDPH).

NCT ID: NCT03430063 Terminated - Clinical trials for Advanced Non-Small Cell Lung Carcinoma

A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer

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

The primary objective of the study is to compare the objective response rate (ORR) of high dose cemiplimab (HDREGN2810) and standard dose cemiplimab plus ipilimumab combination therapy (SDREGN2810/ipi) to the ORR of standard dose cemiplimab (SDREGN2810) in the second-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC), in patients whose tumors express programmed cell death ligand 1 (PD-L1) in <50% of tumor cells.

NCT ID: NCT03429985 Terminated - Clinical trials for Behavior and Behavior Mechanisms

Fathers Raising Responsible Men (FRRM): Addressing Sexual Health

FRRM
Start date: January 3, 2018
Phase: N/A
Study type: Interventional

While existing teen pregnancy prevention efforts have contributed to significant declines in the overall U.S. teen pregnancy rate, teen pregnancy prevention programs specifically targeting adolescent males are limited and sorely needed. The primary aim of the proposed research is to further develop, evaluate, and disseminate a teen pregnancy prevention program specifically designed for adolescent males to enhance the current scientific evidence and intervention options available for broad public health implementation. The proposed intervention Fathers Raising Responsible Men (FRRM) focuses on the adolescent male component of teen pregnancy by identifying and addressing adolescent risk and paternal protective behaviors specific to adolescent males that have not been fully addressed in previous prevention efforts. This study strives to reduce adolescent male sexual risk behavior through targeting African American and Latino adolescent males aged 15-19 and their fathers residing in the South Bronx, specifically Mott Haven and surrounding areas in three phases. Phase I is a pilot study consisting of eight dyads (fathers and sons) to test and refine the intervention and technical and training assistance needs. Phase II is the Randomized Control Trial (RCT) comprised of two cohorts (a total of 500 father-son dyads) to rigorously evaluate the intervention. During the final 6 months of the project, qualitative interviews with 30 father-son dyads will be conducted to triangulate the quantitative RCT results with participant experiences of FRRM. Finally, in Phase III the intervention will be refined and the intervention materials will be available to the general public, while findings will be widely disseminated. These three phases allow for the successful implementation and evaluation of FRRM in conjunction with the refinement and provision of all training and technical assistance necessary for the intervention. If successful, the proposed project will further develop the current scientific evidence and intervention options targeted specifically to the teen pregnancy prevention needs of African American and Latino adolescent males.

NCT ID: NCT03429712 Terminated - Split Dose CT Clinical Trials

Patient- and Task-specific Radiation Dose Optimization for Pediatric Abdominopelvic CT Applications

Start date: September 15, 2018
Phase: N/A
Study type: Interventional

Radiation dose reduction has been a primary driver of technology development in multi-detector computed tomography (MDCT). The optimization of radiation dose for patient and task specific computed tomography (CT) applications continues to be an ongoing challenge, especially in pediatric patients where the desire to reduce radiation dose to lowest possible levels leads to both positive and negative effects. A novel research tool on the Siemens dual source (Flash® and Force ®) CT scanners allows one to assess multiple tube current levels from a single CT acquisition without incurring additional dose to the patient. Tube current is a primary contributor to radiation dose and image noise, which are inversely related. This is achieved by independently adjusting the current of each tube, while maintaining same kV in each x-ray tube. Moreover, Duke's medical physics team has developed a method based on mathematical expressions that allows the creation of incremental dose levels from the acquired image data sets. This innovative and powerful tool can be used to compare diagnostic accuracy, detectability, and many more relevant clinical features amongst multiple tube current levels with the attainment of a single CT acquisition.

NCT ID: NCT03429556 Terminated - Abdominoplasty Clinical Trials

Study to Evaluate Botulinum Neurotoxin Serotype E (EB-001) in Reducing Musculoskeletal Pain in Abdominoplasty

Start date: May 8, 2018
Phase: Phase 2
Study type: Interventional

To determine the safety and efficacy of single intra-operative treatment of Botulinum Neurotoxin Serotype E (EB-001) intramuscular (IM) injections into the Rectus Abdominus (RA) in participants undergoing abdominoplasty.

NCT ID: NCT03429101 Terminated - Breast Cancer Clinical Trials

A Study of Poziotinib in Combination With T-DM1 in HER2-Positive Breast Cancer

Start date: July 13, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase 1b, open-label, multicenter study to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of poziotinib when administered with standard dosing of T-DM1 (3.6 mg/kg IV on Day 1 of each 21-day cycle) in women with advanced or metastatic HER2+ breast cancer. The poziotinib dose identified in Part 1 of the study will be used in combination with standard dose of T-DM1 in Part 2 of the study to confirm the poziotinib dose and evaluate the preliminary efficacy of the combination therapy.

NCT ID: NCT03428984 Terminated - Clinical trials for Postoperative Pain Management

Study in Adult Subjects Undergoing Posterolateral Thoracotomy

Start date: May 3, 2018
Phase: Phase 1
Study type: Interventional

Primary Objective: To characterize the pharmacokinetic (PK) profile of EXPAREL when administered as a posterior intercostal nerve block. Secondary Objective: To assess the safety and tolerability of EXPAREL in this surgical model.

NCT ID: NCT03428945 Terminated - Clinical trials for Type1 Diabetes Mellitus

Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus

TN-22
Start date: August 15, 2018
Phase: Phase 2
Study type: Interventional

The study is a 2-arm, double blinded, multicenter, 2:1 randomized, placebo controlled clinical trial. Subjects will receive hydroxychloroquine or placebo and close monitoring for progression of T1D.