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NCT ID: NCT02737306 Terminated - Clinical trials for Graft Vs Host Disease

A Study of Acute Graft-Versus-Host Disease (GVHD) in Patients Undergoing Allogeneic Stem-Cell Transplantation

GVHD
Start date: May 14, 2017
Phase: Phase 2
Study type: Interventional

This is a Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of PRO 140 for Prophylaxis of Acute Graft-Versus-Host Disease in Patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS) Undergoing Allogeneic Stem-Cell Transplantation.

NCT ID: NCT02737293 Terminated - Obesity Clinical Trials

Whole Egg Intake and the Mediterranean Diet

Start date: April 2016
Phase: N/A
Study type: Interventional

This project will evaluate the daily intake of whole eggs in the Mediterranean Diet (Med Diet). Cholesterol levels are normally related to cardiovascular disease (CVD) risk. Dietary fat and the total diet makeup are well known modifiers of CVD risk. The Med Diet has been shown to decrease blood lipids (fats) and reduce inflammation. Cholesterol intake from eggs may not be as bad as once thought and, in fact, may help to improve the blood lipid (fat) levels. This study is being done to test how the addition of eggs to a Med Diet affects blood lipids and other risk markers for CVD.

NCT ID: NCT02737202 Terminated - Clinical trials for Pulmonary Lymphangioleiomyomatosis

Safety and Efficacy of Saracatinib In Subjects With Lymphangioleiomyomatosis

SLAM-2
Start date: April 2016
Phase: Phase 2
Study type: Interventional

This study is being done to determine if there is a potential benefit of saracatinib in LAM subjects. Based on the information of this trial, additional clinical development trials will be needed. The study will also test the tolerability of 125 mg of saracatinib given once daily over a 9 month period.

NCT ID: NCT02737163 Terminated - Hydrocephalus Clinical Trials

Strata Programmable CSF Shunt Valve Study

Start date: April 1, 2016
Phase:
Study type: Observational

The treatment of hydrocephalus is the most time consuming, and arguably the most important role of the pediatric neurosurgical service at most children's' hospitals. Despite many technological advances, cerebral spinal fluid (CSF) shunting procedures remain the mainstay of hydrocephalus treatment. While often lifesaving, CSF shunting procedures are associated with high complication rates and account for a disproportionate share of health care expenditures and morbidity. Programmable CSF shunt valves, through which CSF flow and pressure can be adjusted by quick and painless transcutaneous reprogramming, have been implanted for more than 15 years in the developed world. Reprogramming these valves relies on rotational magnetic forces, which are applied by neurosurgeons and neurosurgical advanced practice providers. Inadvertent reprogramming (IR) can occur when patients with these valves are exposed to magnetic fields in the environment, which may lead to serious symptoms that may require urgent reprogramming and/or surgery. The concurrent proliferation of magnetically sensitive programmable CSF shunt valves and household items that generate substantial magnetic fields has caused concern among patients, parents and providers about the potential consequences of inadvertent valve reprogramming. This growing concern led the FDA to issue a warning to individuals with programmable valves in 2014, which deemed the programmable valves safe for use but vulnerable to IR when household devices such as tablets or cell phones are placed within 2 inches of the valve. The FDA recommended further study, stating that no systematic evaluation had been performed regarding the prevalence of accidental valve adjustments. By evaluating each of the patients with magnetically susceptible CSF shunt valves, during each of the routine points of contact with the service, investigators aim to define the prevalence of inadvertent shunt reprogramming, to correlate with the presence and absence of symptoms and radiographic changes, and to evaluate the risk of inadvertent shunt reprogramming based on exposure to common environmental items.

NCT ID: NCT02736890 Terminated - Spinal Cord Injury Clinical Trials

Injecting Botulinum Toxin A Underneath the Skin to Treat Spinal Cord Pain in Patients With Spinal Cord Injury

Start date: March 2016
Phase: Phase 2
Study type: Interventional

Back pain is a common secondary condition of both acute and chronic spinal cord injury (SCI). Current existing treatment including both pharmacologic and non-pharmacologic are limited by marginal efficacy or intolerable side effects. The purpose of this study is to evaluate the potential of subcutaneous injections of botulinum toxin A to provide pain relief in spinal cord injury patients with back pain near the level of injury in the spine. Botulinum toxin A has been shown in both pre-clinical and clinical studies to help with nerve pain. The researchers propose a double blinded placebo controlled crossover study to study the effects of subcutaneous botulinum injections to at--level SCI back pain in patients with spinal cord injury.

NCT ID: NCT02736825 Terminated - Skin Laxity Clinical Trials

Simulines Non-Inferiority Pivotal Study

Start date: April 11, 2016
Phase: N/A
Study type: Interventional

Up to 260 subjects presenting with skin laxity on the face and neck will be randomized to one of two treatment groups. Subjects meeting all entrance criteria will receive study treatment, then complete two post treatment phone contacts and follow-up study visits at 90, 180 and 365 days post treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit for qualitative and quantitative assessments of efficacy.

NCT ID: NCT02736578 Terminated - Clinical trials for Pancreatic Adenocarcinoma

Cetuximab-IRDye 800CW and Intraoperative Imaging in Finding Pancreatic Cancer in Patients Undergoing Surgery

Start date: July 2016
Phase: Phase 2
Study type: Interventional

This phase 1-2 trial studies the side effects and best dose of cetuximab-IRDye 800CW when used with intraoperative imaging, to determine the utility of cetuximab-IRDye 800CW to identify and assess pancreatic cancer in patients undergoing surgery to remove the tumor. Cetuximab-IRDye 800CW may help doctors better identify cancer in the operating room by making the cancer visible when viewed through a fluorescent imaging system.

NCT ID: NCT02736188 Terminated - GNE Myopathy Clinical Trials

Study to Evaluate the Safety and Efficacy of Aceneuramic Acid Extended-Release (Ace-ER) Tablets in Patients With Glucosamine (UDP-N-acetyl)-2-epimerase Myopathy (GNEM) or Hereditary Inclusion Body Myopathy (HIBM)

Start date: May 2, 2016
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the long-term safety and efficacy of Ace-ER treatment in subjects with GNEM.

NCT ID: NCT02736149 Terminated - Clinical trials for Pulmonary Arterial Hypertension

Open-Label Extension Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1)

LIBERTY2
Start date: December 2016
Phase: Phase 2
Study type: Interventional

Ubenimex is being developed for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group 1) to improve exercise capacity and delay clinical worsening. This study is a Phase 2, open-label, extension study to evaluate long-term safety and efficacy of ubenimex in patients with PAH (WHO Group 1) who complete Study EIG-UBX-001.

NCT ID: NCT02735720 Terminated - Clinical trials for Thoracic Aortic Aneurysm

The CardiOvascular Remodeling Following Endovascular Aortic Repair (CORE) Study

CORE
Start date: March 14, 2017
Phase:
Study type: Observational [Patient Registry]

The use of TEVAR is increasing rapidly and patients even in younger patients. However, current endografts are several orders of magnitude stiffer than the native aorta. Pre-clinical and clinical studies have reported acute aortic stiffening after TEVAR resulting in hypertension, elevated pulse pressure, cardiac remodeling, reduced coronary perfusion, and finally, heart failure. These effects are markedly profound in young patients, as their hearts and aortas are more compliant. Previous studies on adverse cardiovascular remodeling have important limitations, such as retrospective design, use of echocardiography (with low reproducibility and high operator-dependency), and mixed populations. A systematic assessment of the deleterious effects of TEVAR is still missing. The objective of this study is to perform a prospective, non-randomized controlled, study in which blood pressure, heart rate, ECG, echocardiography, CT, MRI, intra-luminal hemodynamic assessment, computational modeling and biomarkers are used to assess cardiovascular remodeling following TEVAR. This study targets patients with thoracic aortic aneurysms (TAA) or penetrating aortic ulcers (PAU) treated with TEVAR. A control group will consist of TAA and PAU subjects who do not require endovascular treatment. The specific aims of the study include: 1) Quantification of cardiovascular remodeling following TEVAR in TAA or PAU patients. 2) Validation of computational modeling of thoracic aortic hemodynamics following TEVAR using the above clinical measurements. Once validated, computational analyses will be performed to virtually assess the impact of more compliant endografts on cardiac and aortic hemodynamics. 3) Investigation of diagnostic accuracy of ECG, BNP, NT-pro-BNP and Troponin T, for cardiac remodeling compared to MRI, the reference method. This study will assess the impact of thoracic aortic stent grafts on the cardiovascular system through non-invasive measurements. Although there are no direct benefits for the enrolled subjects, future aortic patients might benefit from better patient management with improved aortic endograft designs and long-term outcomes.