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NCT ID: NCT03451474 Terminated - Clinical trials for Spinal Cord Injuries

Restoring Hand Function Utilizing Nerve Transfers in Persons With Cervical Spinal Cord Injuries

Start date: April 1, 2018
Phase: N/A
Study type: Interventional

The primary objective of this study is to evaluate the safety and efficacy of nerve transfer surgery for restoring hand function as a therapy for patients with cervical spinal cord injury.

NCT ID: NCT03472833 Terminated - Quality of Life Clinical Trials

High-dose Vitamin D3 in Pancreas Cancer

VITdCUT
Start date: April 1, 2018
Phase: Phase 3
Study type: Interventional

Different studies have shown that a deficiency in vitamin D (≤20ng/mL) results in higher rates in morbidity and mortality rates in cancer patients. Clinical studies investigated and demonstrated altered vitamin d tissue in pancreatic cancer. But there is no prospective study evaluating the beneficiary effects of oral supplementation of vitamin d in altered vitamin d tissue from pancreatic cancer. We want to examine the effect of a high dose vitamin D3 therapy vs. a standard base dose vitamin D3 therapy in pancreas cancer patients with a vitamin D deficiency. In case of benefit in our results we could implement vitamin D3 as a supportive standard therapy in pancreatic cancer patients.

NCT ID: NCT03473457 Terminated - Clinical trials for Relapsed/Refractory Acute Myeloid Leukemia(AML)

CAR-T Cells Therapy in Relapsed/Refractory Acute Myeloid Leukemia

AML
Start date: April 1, 2018
Phase: N/A
Study type: Interventional

Acute myeloid leukemia (AML) is a group of genetically highly heterogeneous malignant disease . The disease is the most common type of adult acute leukemia. Overall survival (OS) was less than 50% in 5 years. Chimeric Antigen Receptor-transduced T cell (CAR-T) therapy is one of revolutionary targeted immunotherapy. The efficacy of CAR-T cells for the treatment of acute B lymphocytic leukemia has been widely recognized, although it start late, several clinical trials have been register in ClinicalTrials.gov.

NCT ID: NCT03492736 Terminated - Clinical trials for Obstructive Sleep Apnea

Effects of Melatonin in Untreated Obstructive Sleep Apnea

Start date: April 1, 2018
Phase: Early Phase 1
Study type: Interventional

The investigators have previously shown that 1 week of 10mg Melatonin improves sleep consolidation in untreated obstructive sleep apnea (OSA) patients. This study aims to extend on those findings to determine if longer treatment of Melatonin improves other outcomes in untreated OSA patients.

NCT ID: NCT03521310 Terminated - Prematurity Clinical Trials

Immediate Parent -Infant Skin-to-Skin Study (IPISTOSS)

Start date: April 1, 2018
Phase: N/A
Study type: Interventional

The World Health Organization recommend all stable low birth weight neonates to have Skin-to-skin-Contact (SSC) after birth. Intermittent SSC is used in Sweden in neonatal units. Observations indicate that SSC makes neonates feel good. However, there is limited research done on SSC treatment on neonates born prior to week 33. The aim of this study is to investigate whether Skin-to-skin-Contact (SSC) leads to an improved physiological stabilization, altered epigenetic profile and improved longterm psychomotor outcome in neonates born in gestation age between week 28+0 - 32+6. This is a parallel, two-arm, multicentre, randomized controlled superiority trial. The two arms to be compared are a) immediate SSC with one parent/caregiver continous during the first 6 hours after birth and as much as possible during the first 72 hours, and b) conventional method of care during the same time.

NCT ID: NCT03602456 Terminated - Health Insurance Clinical Trials

Evaluation of the Health and Economic Consequences of Kentucky's Section 1115 Demonstration Waiver

Start date: April 1, 2018
Phase:
Study type: Observational

Kentucky HEALTH was an 1115 Medicaid waiver that was approved by the Centers for Medicare and Medicaid Services (CMS) in January 2018. In what was initially planned to be a 5-year demonstration, KY HEALTH aimed to modify the traditional Medicaid program to improve health behaviors, health outcomes, and socioeconomic outcomes in the waiver-eligible population through several innovations. In brief, these included introducing Community Engagement requirements (i.e. work requirements), monthly premiums, MyRewards accounts for dental and vision services, and annual recertification. If beneficiaries failed to complete these requirements, some penalties included suspension and 6-month lockouts from the Medicaid program. The Commonwealth of Kentucky had chosen to implement this program in a randomized fashion, where 10% of the target population was randomly assigned to continue receiving traditional Medicaid while 90% would receive Kentucky HEALTH benefits and be subject to the requirements discussed above. Randomization was conducted by the state, through their separate contract with a non-profit research firm (National Opinion Research Center, NORC). The NORC also engaged in primary data collection to support the analysis of the project. The University of Pennsylvania team served as the non-partisan, independent evaluators of this randomized intervention conducted by the Commonwealth of Kentucky. The analysis would measure the impact of KY HEALTH compared to traditional Medicaid. Due to ongoing legal challenges and a change in administrations, the implementation of Kentucky HEALTH was delayed and eventually cancelled. On March 27, 2019, the DC District Court Judge concluded that the approvals did not address how the requests would align with Medicaid's core objectives. At that point, data collection was ongoing although Kentucky HEALTH was delayed until further notice. Kentucky's 2019 gubernatorial election took place on November 5th and resulted in the election of a new governor. On December 16, 2019, a termination request was sent to CMS as a notification of the new administration's intention to cancel Kentucky HEALTH. On December 18, 2019, a clarification letter was sent to CMS to notify them that the termination did not apply to the SUD program and NEMT portion (among others) of the waiver. While the Penn team will continue conducting a separate evaluation of the ongoing SUD program, the randomized controlled trial and data collection described in this study will end with the terminated components of the waiver. As a result of the legal challenges, the implementation of Kentucky HEALTH was delayed before being cancelled altogether. The study start and end dates above reflect the beginning of data collection and the termination letter that was sent to CMS, respectively. A total of 9,396 surveys (KHES), 127 beneficiary semi-structured interviews, and 40 provider interviews were conducted.

NCT ID: NCT03680066 Terminated - Food Allergy Clinical Trials

Study to Assess Tolerance of Traces in Peanut/Tree Nut Allergic Children.

Start date: April 1, 2018
Phase: N/A
Study type: Interventional

This protocol will help better define whether patients with peanut and/or tree nut food allergy can tolerate traces in products with precautionary allergen labelling.

NCT ID: NCT03764761 Terminated - Down Syndrome Clinical Trials

Storybook Reading in Individuals With Down Syndrome

Start date: April 1, 2018
Phase: N/A
Study type: Interventional

This study uses mobile eye-tracking technology in order to characterize patterns of visual attention to communication supports, as well as a partner, within real world interactions for individuals with Down syndrome. Visual communication supports are central components of what is termed augmentative and alternative communication (AAC) intervention. AAC refers to the methods and technology designed to supplement spoken communication for people with limited speech. "Aided" AAC is a subcategory in which an external aid stores and presents for use visual symbols such as photographs, line drawings, or alphabet letters. The most traditional means of structuring aided AAC displays is to present the language concepts within row-column grids, which contain individual symbols/concepts placed in each grid square. The investigator's previous work investigated whether these grid-based presentations could be improved by understanding how different perceptual features of the displays influence responding (i.e., whether what the display looks like influences how easily the information on it is found). Individuals with developmental disabilities and children developing typically were faster and more accurate in finding information on some displays over others, when tested using a "visual search" task (aka, a "finding game" - "find the dog"). The previous investigations have evaluated visual attention within a setting that isolated visual processing of the AAC display as the primary dependent measure. However, communication requires attention not only to an AAC display, but also to a communication partner. Therefore, the current study seeks to examine questions of visual attention to both an AAC display and a communication partner. The investigators will manipulate characteristics of the structure of the display (e.g., arrangement of symbols), in order to determine if more optimal displays facilitate desirable patterns of visual attention to both the communication display and the partner. The mobile eye-tracking technology captures attention to both the display and the communication partner. The investigators anticipate that participants will be able to attend to their partner and the shared activity more when the AAC display is more optimal, but that when the AAC display is sub-optimal, the participants will have to spend more time examining the AAC display and less time in actual communication.

NCT ID: NCT03245827 Terminated - Clinical trials for Hypogonadism, Hypogonadotropic

Hypogonadotropic Hypogonadism in Obese Young Males

Start date: April 1, 2019
Phase: Phase 2
Study type: Interventional

Obesity can lead to low testosterone concentrations in young men. This study will study the effects of low testosterone in those men and the result of treating them with clomiphene.

NCT ID: NCT03308786 Terminated - HIV Infection Clinical Trials

HIV Reservoir Reduction With Interleukin-2

IL2
Start date: April 1, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this pilot study is to examine the effects of eight 4-day cycles of subcutaneous recombinant interleukin-2 (rIL-2) given every 8 weeks on levels of replication-competent HIV in CD4 cells and on the size of HIV viral reservoir in up to 20 participants with chronically suppressed HIV infection (viral load <50 copies/mL).