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NCT ID: NCT03267940 Terminated - Clinical trials for Cholangiocarcinoma, Intrahepatic

Study of PEGPH20 With Cisplatin (CIS) and Gemcitabine (GEM); PEGPH20 With Atezolizumab (ATEZO), CIS, and GEM; and CIS and GEM Alone in Participants With Previously Untreated, Unresectable, Locally Advanced, or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma

Start date: October 2, 2017
Phase: Phase 1
Study type: Interventional

The study is being conducted to assess the safety and tolerability of (1) PEGPH20 in combination with CIS and GEM (PEGCISGEM), and (2) PEGPH20 in combination with CIS, GEM, and atezolizumab (PEGCISGEMATEZO) compared with (3) cisplatin and gemcitabine (CISGEM).

NCT ID: NCT03267836 Terminated - Meningioma Clinical Trials

Neoadjuvant Avelumab and Hypofractionated Proton Radiation Therapy Followed by Surgery for Recurrent Radiation-refractory Meningioma

Start date: January 10, 2018
Phase: Phase 1
Study type: Interventional

Meningioma is the most common central nervous system (CNS) tumor and accounts for approximately 30% of all CNS tumors. For meningioma recurring after surgery and radiation therapy, there is no effective medical therapy. Repeat surgery or radiation therapy may be possible, but they are temporizing measures with limited durable relief. PD-L1 expression in meningioma is increased for recurrent tumors or prior radiation therapy, and a recent case study reported significant reduction of an intracranial meningioma after 6 months of PD-L1 blockade. Radiation has been shown to augment immune response when combined with PD-L1 blockade. Proton radiation therapy has higher relative biological effectiveness (RBE) and may further amplify the above immunological signals. Combination of proton radiation therapy administered concurrently with PD-L1 inhibitor may maximize immune response for recurrent meningioma. However, confirmation of the increased immunogenicity or increased tumor infiltrating lymphocytes using the combination of radiation therapy and PD-L1 blockade have not been confirmed in patients. The proposed study will be a single institution, single-arm, open-label, phase Ib study to combine neoadjuvant avelumab (a PD-L1 inhibitor) with hypofractionated proton therapy of 20 CGE (cobalt gray equivalent) over 5 fractions followed by planned surgery for recurrent radiation-refractory meningioma. This study is designed to provide proof of concept to demonstrate on-target effect of the combination to increase immunogenicity by directly examining the resected tumor for immune response and to evaluate preliminary clinical efficacy

NCT ID: NCT03267810 Terminated - Clinical trials for Spinal Cord Injuries

TENS Trial to Prevent Neuropathic Pain in SCI

TENS
Start date: August 14, 2017
Phase: N/A
Study type: Interventional

The purpose of this research study is to: 1) test whether transcutaneous electrical nerve stimulation (TENS) after spinal cord injury can reduce the onset of post-injury neuropathic pain; and 2) to learn more about this kind of pain and who is at risk for suffering from this type of pain after spinal cord injury. Neuropathic pain is a type of pain that occurs in about 50% of people with spinal cord injury. This type of pain is usually described as "burning" or "tingling," and is present around the level of injury and/or in areas below the level of injury. The investigators' goal is to try a non-drug treatment (TENS) that may help prevent this pain from occurring. Pain symptoms will be compared between the study participants who receive active TENS and the study participants who receive a sham TENS treatment.

NCT ID: NCT03267368 Terminated - Lung Cancer Clinical Trials

Comprehensive Care Program SBRT

Start date: September 11, 2017
Phase: N/A
Study type: Interventional

Pulmonary (lung) rehabilitation, which is done under the guidance of lung specialists/therapists. It includes breathing exercises, physical exercises, and exercises to increase tolerance of activity (stamina). This type of lung rehab has been shown to improve symptoms, quality of life, breathing, and walking distance. It has also been shown to decrease hospitalization and death rates in chronic obstructive pulmonary disease (COPD) and lung cancer patients. Comprehensive Care Management Program (CCMP), a program that includes educational sessions for tobacco cessation, phone calls, and a home action plan has also demonstrated benefit in addition to the pulmonary rehabilitation. In this study, the investigators have an opportunity to identify and intervene with COPD patients. The vast majority of early stage lung cancer patients are much more scared of their cancer than their COPD. Upon identification of COPD and recognition of patient tobacco habits for patients planned to undergo SBRT, interventions can potentially be made that will reduce COPD hospitalization rates, second primary lung cancer rates, and likely death rates. The interventions are broadly available and relatively easily instituted and include the following: seeing a doctor to diagnose their other underlying illness or illnesses (both respiratory and cardiovascular), smoking cessation if they are smokers, and CCMP's and pulmonary rehabilitation which have shown measurable COPD benefits in prior trials.

NCT ID: NCT03267108 Terminated - Clinical trials for Pulmonary Hypertension

A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary Hypertension

REBUILD
Start date: December 14, 2020
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, placebo-controlled dose escalation and verification study to assess the safety and efficacy of pulsed inhaled nitric oxide (iNO) in subjects at risk for pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2) - REBUILD

NCT ID: NCT03266692 Terminated - Multiple Myeloma Clinical Trials

Study of ACTR087 in Combination With SEA-BCMA in Subjects With Relapsed or Refractory Multiple Myeloma

Start date: February 22, 2018
Phase: Phase 1
Study type: Interventional

This is a phase 1, multi-center, single-arm, open-label study evaluating the safety, tolerability, and anti-myeloma activity of ACTR087 (an autologous T cell product) in combination with SEA-BCMA (a monoclonal antibody) in subjects with relapsed or refractory Multiple Myeloma.

NCT ID: NCT03265717 Terminated - Clinical trials for Leukemia, Lymphocytic, Chronic, B-Cell

DNA Plasmid Encoding a Modified Human Telomerase Reverse Transcriptase (hTERT), Invac-1 in Chronic Lymphocytic Leukemia

Start date: July 25, 2018
Phase: Phase 2
Study type: Interventional

Phase 2 study to assess the efficacy of INVAC-1, a DNA plasmid encoding a modified human telomerase reverse transcriptas (hTERT) protein, at a dose of 800 µg for 6 cycles 4 weeks apart on Minimal Residual Disease (MRD) eradication rate in the bone marrow, either as a single agent in a high risk "watch and wait" group (group 1 - 42 patients) or in combination with ibrutinib (group 2 - 42 patients), in patients with Chronic Lymphocytic Leukemia (CLL). Pharmacodynamics and safety will also be assessed.

NCT ID: NCT03265249 Terminated - Pain, Postoperative Clinical Trials

BRIDGE Device for Post-operative Pain Control

BRIDGE
Start date: February 12, 2018
Phase: N/A
Study type: Interventional

Auricular neurostimulation is a potential novel and non-invasive method of pain control following liver transplantation in a growing patient population with the probability of significant impact on economics and morbidity. The investigators propose a pilot study to investigate the effects of auricular neurostimulation in patients receiving a liver transplantation. The investigator will investigate the effects of auricular neurostimulation with this novel device and compare it to the current standard of care for pain management following liver transplantation.

NCT ID: NCT03265132 Terminated - Clinical trials for Still's Disease, Adult-Onset

A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Still's Disease (SJIA and AOSD)

anaSTILLs
Start date: September 26, 2017
Phase: Phase 3
Study type: Interventional

The aim of this study is to demonstrate the efficacy and to evaluate the safety, pharmacokinetics (PK) and immunogenicity of anakinra in patients with newly diagnosed Still's disease, including SJIA (Systemic juvenile idiopathic arthritis) and AOSD (Adult-onset Still's disease).

NCT ID: NCT03265080 Terminated - Metastatic Melanoma Clinical Trials

A Study of ADXS-NEO Expressing Personalized Tumor Antigens

NEO
Start date: March 28, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, multicenter study of ADXS-NEO administered alone and in combination with pembrolizumab in participants with select advanced or metastatic solid tumors. This study will be performed in 2 phases, a safety phase (Part A and Part B) and an efficacy phase (Part C).