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NCT ID: NCT03829449 Terminated - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study

CONSERVE
Start date: March 13, 2017
Phase: Phase 3
Study type: Interventional

Patients with diseases requiring complement inhibition who have previously taken part in Akari clinical trials and who wish to continue to receive rVA576 (Coversin) after their active participation in the parent trial has completed and patients treated under compassionate use or named patient arrangements who wish to continue on rVA576 (Coversin) therapy.

NCT ID: NCT03828487 Terminated - Clinical trials for Regional Saturation of Oxygen (rSO2)

Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates

Start date: December 19, 2018
Phase: N/A
Study type: Interventional

The aim of the study is to compare the performance of the O3 cerebral oximeter and sensor to a 510(k) cleared NIRS (Near-Infrared Spectroscopy) device on neonatal subjects based on data collected from the cutaneously placed forehead sensors. Due to the design of the systems, the devices will be used serially instead of concurrently. Because of this timing, changes in patient state may not be reflected in measurements collected by both devices.

NCT ID: NCT03828136 Terminated - Clinical trials for Symptomatic Cervical Disc Disease

Novum Vitrium® Cervical Cage in Anterior Cervical Discectomy and Fusion

Start date: April 24, 2019
Phase: N/A
Study type: Interventional

A prospective, multicenter, randomized, concurrently controlled, noninferiority clinical trial to compare the safety and effectiveness of instrumented Bio2 Vitrium Cervical Interbody Device in anterior cervical discectomy and fusion (ACDF) with structural allograft bone and local autologous bone graft in treating patients with a symptomatic degenerative cervical disc disease at one level from C3/C4 to C7/T1.

NCT ID: NCT03827473 Terminated - Clinical trials for Stage IV Prostate Cancer

Docetaxel or Abiraterone Acetate With ADT in Treating Patients With Metastatic Hormone Sensitive Prostate Cancer

ACADEMIC
Start date: February 8, 2019
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well docetaxel or abiraterone acetate work when combined with androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as docetaxel and abiraterone acetate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Antihormone therapy, such as ADT may lessen the amount of androgen made by the body. It is not yet known whether docetaxel or abiraterone acetate work better when combined with ADT in treating patients with hormone sensitive prostate cancer.

NCT ID: NCT03827044 Terminated - Clinical trials for Stage III Colon Cancer

Avelumab Plus 5-FU Based Chemotherapy as Adjuvant Treatment for Stage 3 MSI-High or POLE Mutant Colon Cancer

POLEM
Start date: August 31, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if dMMR and/or POLE exonuclease domain mutant stage III colon cancer patients gain clinical benefit (i.e. improvement in disease free and overall survival) from PD-L1 inhibitors after standard fluoropyrimidine-based adjuvant chemotherapy. Avelumab binds PD-L1 and blocks the interaction between PD-L1 and PD-1. This removes the suppressive effects of PD-L1 on anti-tumour CD8+ T cells, resulting in the restoration of cytotoxic T cell response. The rationale of giving Avelumab after standard adjuvant chemotherapy to this well-defined, molecularly-selected, group is based on the fact that dMMR and POLE exonuclease domain mutant CRCs have a highly and ultra-mutated genetic profile, respectively, thus leading to a high number of neo-antigens with associated over expression of immune checkpoint related proteins. This profile is expected to be highly responsive to checkpoint inhibition as suggested by data of PD-1 inhibitors in dMMR/MSI-H metastatic CRCs. If this study meets the primary endpoint, using Avelumab in the adjuvant setting following standard chemotherapy would become the standard of care for patients with dMMR and/or POLE exonuclease domain mutant colon cancers. Furthermore, given the availability of molecular markers for patient selection, funders of healthcare would be more likely to fund this treatment. This study also provides a unique opportunity to conduct translational research analyses on pre- and post-treatment tumour tissue samples and blood samples from dMMR or POLE mutant CRC patients treated with the checkpoint inhibitor Avelumab.

NCT ID: NCT03823703 Terminated - Clinical trials for Nonalcoholic Steatohepatitis (NASH)

Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Participants With Presumed Nonalcoholic Steatohepatitis (NASH)

Start date: November 4, 2020
Phase: Phase 2
Study type: Interventional

This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and efficacy of miricorilant (CORT118335) in patients with presumed Nonalcoholic Steatohepatitis (NASH).

NCT ID: NCT03823131 Terminated - Clinical trials for Recurrent Head and Neck Squamous Cell Carcinoma

Optimizing Antitumor Immunity Using Plasmid Electroporation, Pembrolizumab, and Epacadostat

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

This phase II trial studies how well tavokinogene telseplasmid with electroporation (tavo-EP), pembrolizumab, and epacadostat work in treating patients with squamous cell carcinoma of the head and neck that cannot be removed by surgery. Tavokinogene telseplasmid with electroporation is a gene therapy that may delay of tumor growth and which may have less toxicity than other methods of gene delivery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Epacadostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving tavokinogene telseplasmid with electroporation, pembrolizumab, and epacadostat may work better in treating squamous cell carcinoma of the head and neck.

NCT ID: NCT03821831 Terminated - Pediatric Obesity Clinical Trials

Treating Children With Obstructive Sleep Apnea After Surgery Failure

Start date: December 3, 2021
Phase:
Study type: Observational

The aim of this study is to evaluate the potential improvement of sleep quality in children who have residual obstructive sleep apnea, using either an orthodontic intervention or continuous positive airway pressure (CPAP), versus no treatment.

NCT ID: NCT03815669 Terminated - Clinical trials for Arthroscopic Subacromial Decompression

Improving Quality of Treatment for Shoulder Patients

Start date: January 1, 2019
Phase:
Study type: Observational

Introduction: Previous studies indicate that patient characteristics and clinical and psychological factors are related to the effect of surgical treatment but more knowledge about predictors is important in the selection of patients for arthroscopic subacromial decompression. Objective: To identify patient characteristics and clinical and psychological factors for pre-operatively predicting the effect of arthroscopic subacromial decompression. Method: Patients meting the inclusion criteria will consecutively be enrolled in the study when referred to arthroscopic subacromial decompression. Prior to surgery, patient characteristics and clinical data will be collected. At six and twelve month postoperatively, the effect of the surgical treatment will be assessed. The relationship between effect of surgery and patient characteristics and clinical factors collected at baseline will be examined.

NCT ID: NCT03814382 Terminated - Clinical trials for Alzheimer's Dementia With Behavioral Disturbance

Acupuncture to Reduce Anxiety in Alzheimer's Disease (AD) and AD Related Dementias

Start date: March 11, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the influence of acupuncture on heart rate variability, skin conductance (sweating), and rated behavioral expression of agitation, irritability, and anxiety and mood in qualifying adults with a diagnosis of cognitively unimpaired, or probable Alzheimer's Disease, Frontotemporal Dementia or Dementia with Lewy Bodies. Study subjects will all receive one real acupuncture treatment; mood scales will be assessed before and after. Massachusetts General Hospital is paying for this research to be done.