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NCT ID: NCT03115476 Terminated - Clinical trials for Squamous Cell Carcinoma

A Trial to Compare the Incidence of Squamous Cell Carcinoma (SCC) and Other Skin Neoplasia on Skin Areas Treated With Ingenol Disoxate Gel or Vehicle Gel for Actinic Keratosis on Face and Chest or Scalp

Start date: June 16, 2017
Phase: Phase 3
Study type: Interventional

One of the main reasons for treating actinic keratoses (AK) is the wish to lower the risk of progression of AK to squamous cell carcinoma (SCC). This risk is in the order of 1 per 1000 AKs per year, which is in itself a small risk, but since patients can have dozens of AKs and the disease is chronic the cumulative risk for a patient can be substantial. In this extension protocol of trials LP0084-1193, -1194, -1195 and -1196, LEO will study the incidence of SCCs and other skin neoplasia in vehicle and ingenol disoxate treated patients over a period of 2 years, so that the total follow-up time for each patient will be 3 years and 2 months.

NCT ID: NCT03115385 Terminated - Adiposity Clinical Trials

Probiotics and the Gut Microbiome in Obese Hispanic Youth

Start date: May 30, 2015
Phase: N/A
Study type: Interventional

This study will recruit 40 obese Hispanic youth (12 - 18 years of age who are greater than or equal to Tanner stage 4) from hospitals, clinics, and community centers. Participants will be randomly assigned to 16 weeks of probiotics (3 packets/day of VSL#3) or matched placebo. The purpose of this study is to demonstrate through a proof-of-concept trial that probiotics have the potential to alter the gut microbiome and gut hormones.

NCT ID: NCT03115151 Terminated - Pain Clinical Trials

Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery

Start date: May 8, 2017
Phase: Phase 4
Study type: Interventional

Postoperative analgesia following spine surgery is difficult to manage. Current treatment modalities rely heavily on opioid analgesics with all of the inherent limitations and side effects. While current best practice focuses on a 'multimodal approach' (i.e. using multiple different drugs and techniques to control pain after surgery), there is no consensus regarding which components of this multimodal therapy provide optimal analgesia. This prospective randomized study will enroll patients undergoing elective Lumbar Spinal Fusion Surgery at Zale Lipshy University Hospital. The primary objective is to determine the comparative efficacy of epidural analgesia, as compared with intravenous (IV) patient-controlled analgesia (PCA), on post-operative analgesia.

NCT ID: NCT03114657 Terminated - Alzheimer's Disease Clinical Trials

A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease (AD)

CREAD 2
Start date: March 29, 2017
Phase: Phase 3
Study type: Interventional

This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (Q4W) for 100 weeks. The primary efficacy assessment will be performed at 105 weeks. The participants who do not enter open-label extension will enter for a long term follow-up period for up to 52 weeks after the last crenezumab dose (Week 153).

NCT ID: NCT03114566 Terminated - Healthy Clinical Trials

Collection and Generation of Antigen-specific T-lymphocyte Cell Lines From Primary, Third-party, Related, and Unrelated Donors

Start date: April 5, 2017
Phase:
Study type: Observational

The purpose of this study is to obtain lymphocyte collections from normal healthy volunteer donors in order to create Good Manufacturing Practice grade banks of virus-specific and tumor-reactive T-cells of defined HLA type and restricting HLA allele readily available for therapeutic use.

NCT ID: NCT03113877 Terminated - Clinical trials for Cornelia de Lange Syndrome

Evaluation of Autonomic Function in Individuals With Cornelia de Lange Syndrome (CdLS)

Start date: August 2016
Phase:
Study type: Observational

Based on survey data, individuals with Cornelia de Lange Syndrome (CdLS) often experience symptoms of autonomic dysfunction however there are no reported studies in which these patients have had objective testing of the autonomic nervous system. This is a pilot study in which patients with CdLS will undergo the standard clinical testing for autonomic dysfunction with a autonomic reflex screen and thermoregulatory sweat test.

NCT ID: NCT03113409 Terminated - Opioid-use Disorder Clinical Trials

Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol

Start date: June 1, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

The study will enroll 30 opioid-dependent participants into an open-label pilot outpatient study of methods to facilitate induction and stabilization onto XR-NTX. There will be three different methods of XR-NTX induction using increasing doses of oral naltrexone and buprenophine.

NCT ID: NCT03113383 Terminated - Clinical trials for Thoracoabdominal Aortic Aneurysm

Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms

Start date: August 18, 2017
Phase: N/A
Study type: Interventional

The primary objective of the clinical investigation is to assess the use of the the Visceral Manifold Thoracoabdominal Aortic Aneurysms (VTAAA) stent graft system to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety (i.e. freedom from major adverse events (MAE) at 30 days) and preliminary effectiveness (i.e., treatment success and technical success) of the device (i.e., the proportion of treatment group subjects that achieve and maintain treatment success at one year).

NCT ID: NCT03113071 Terminated - Clinical trials for Acute Myeloid Leukemia

Safety and Activity of Digoxin With Decitabine in Adult AML and MDS

Start date: June 2, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The primary hypothesis is that digoxin can be safely added to decitabine and will increase the response rates in medically unfit patients with newly diagnosed AML/MDS or those with relapsed/refractory AML/MDS. Furthermore, it is hypothesized that the addition of digoxin to decitabine will result in distinct epigenetic alterations in AML/MDS patients.

NCT ID: NCT03112902 Terminated - Clinical trials for Mild Cognitive Impairment

Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance

Start date: March 7, 2018
Phase: N/A
Study type: Interventional

Loss of slow wave sleep (SWS) is common in mild cognitive impairment (MCI) and Alzheimer's disease, and is thought to worsen thinking, memory and brain degeneration. Initial studies suggest that correction of sleep deterioration may slow the progression of brain damage in mild cognitive impairment, and might be able to stop the development of Alzheimer's disease. Transcranial alternating current stimulation (tACS) uses electrodes to deliver very small amounts of electricity through the brain, with direct effects on brain cell function. Transcranial electric stimulation has been demonstrated to enhance slow wave sleep and to improve memory when applied during sleep in healthy adults. The purpose of this research is to investigate tACS to modulate sleep, thinking/memory, mood, and quality of life among normal healthy adults, older adults, as well as individuals with MCI.