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NCT ID: NCT03637764 Terminated - Neoplasm Clinical Trials

Safety, Preliminary Efficacy and PK of Isatuximab (SAR650984) Alone or in Combination With Atezolizumab in Patients With Advanced Malignancies

Start date: August 6, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Primary Objectives: - Phase 1: To characterize the safety and tolerability of isatuximab in combination with atezolizumab in participants with unresectable hepatocellular carcinoma (HCC), platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN), platinum-resistant/refractory epithelial ovarian cancer (EOC), or recurrent glioblastoma multiforme (GBM), and to determine the recommended Phase 2 dose (RP2D). - Phase 2: To assess response rate (RR) of isatuximab in combination with atezolizumab in participants with HCC or SCCHN or EOC. - Phase 2: To assess the progression free survival rate at 6 months (PFS-6) of isatuximab in combination with atezolizumab, or as a single agent in participants with GBM. Secondary Objectives: - To evaluate the safety profile of isatuximab monotherapy (GBM only), or in combination with atezolizumab in Phase 2. - To evaluate the immunogenicity of isatuximab and atezolizumab. - To characterize the pharmacokinetic (PK) profile of isatuximab single agent (GBM only) and atezolizumab in combination with isatuximab. - To assess the overall efficacy of isatuximab in combination with atezolizumab, or single agent (GBM only).

NCT ID: NCT03635996 Terminated - Clinical trials for Paroxysmal Supraventricular Tachycardia

Safety Study of Intranasal Etripamil for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia (PSVT). NODE-302

Start date: December 10, 2018
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the safety of etripamil nasal spray (NS) 70 mg when self-administered by patients with an episode of Paroxysmal Supraventricular Tachycardia in an outpatient setting (i.e., without medical supervision).

NCT ID: NCT03635671 Terminated - Clinical trials for Diabetic Retinopathy

Diabetic Retinopathy and Subclinical Signs of Disease Transition

DIRECTION
Start date: September 1, 2018
Phase:
Study type: Observational

The prevalence of diabetes mellitus (DM) is increasing worldwide. Diabetic retinopathy is the most prevalent complication of DM and a leading cause of visual impairment. Some factors are known to temporarily aggravate or improve diabetic retinopathy, but underlying pathophysiologic factors are still unknown. High-resolution imaging techniques of the retina and its supplying vascular networks now allow novel insight to subtle changes that cannot be appreciated in standard fundus examination. In detail, the investigators image study patients with optical coherence tomography (OCT) - technology, that provides morphological information of retinal structure and the supplying vessels in a non-invasive way. Retinal layer thickness as well as capillary density will be quantified and followed in patients that are in a critical period of disease transition to better understand the process of diabetic retinopathy.

NCT ID: NCT03633227 Terminated - Clinical trials for Liver Cirrhosis, Biliary

Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment

Start date: June 22, 2018
Phase: Phase 4
Study type: Interventional

This Phase 4, randomized, double-blind, placebo-controlled study will evaluate the pharmacokinetics (PK) and safety of OCA treatment in participants with PBC and moderate to severe hepatic impairment over a 48-week treatment period. Participants who have completed their 48-week double blind treatment period will continue double-blind treatment until all randomized participants have completed their 48-week treatment period and the database for that period is locked. An open-label extension study in which all participants receive OCA will be considered following review of blinded safety and PK data.

NCT ID: NCT03628014 Terminated - Delirium Clinical Trials

The Hospital Elder Life Program at the Jewish General Hospital

HELP
Start date: February 5, 2018
Phase: N/A
Study type: Interventional

Older patients (i.e.; ≥ 65 years) with a hip fracture, and who are admitted to orthopedics for surgery are particularly at risk of adverse health events such as delirium, recurrent falls and prolonged hospital stay caused by their frailty status. The Hospital Elder Life Program (HELP) is a comprehensive inpatient-care program that ensures optimal care for older adults in the hospital and, thus, might reduce the incidence of postoperative adverse health events. The overall objective of this study is to examine in a quantitative fashion the effects of the HELP program on adverse health events in geriatric inpatients admitted to the orthopedic ward at JGH for surgery after a hip fracture.

NCT ID: NCT03626545 Terminated - Non-Small-Cell Lung Clinical Trials

Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy

CANOPY-2
Start date: January 23, 2019
Phase: Phase 3
Study type: Interventional

This study was designed to evaluate the role of canakinumab in combination with docetaxel in subjects with advanced non-small cell lung cancer (NSCLC) previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy.

NCT ID: NCT03620253 Terminated - Clinical trials for Major Depressive Disorder

Modafinil's Effects on Cognition in Remitted MDD

Start date: October 15, 2018
Phase: Phase 3
Study type: Interventional

Cognitive difficulties such as indecisiveness or inability to concentrate are core symptoms of depression with up to 90% of untreated depressed individuals experiencing these symptoms. As many as half of those who remit from a major depressive episode continue to experience residual cognitive deficits, but these symptoms are frequently overlooked in clinical practice. This leads to persistent cognitive deficits which can cause reduced level of functioning and loss of productivity. As standard antidepressants have an inadequate impact on these residual cognitive symptoms, further treatment options are required. Modafinil is a wakefulness agent with evidence that it improves some domains in cognition such as memory in those whose non-cognitive depressive symptoms have been treated over a short term period. This medication may have favourable lasting effects on cognition, such as the ability to plan and execute tasks in those who receive modafinil for a longer time period. The aim of this study is to investigate whether modafinil can enhance cognition and have additional effects on functioning and work productivity in a sample of participants who were treated for depression but who continue to experience cognitive deficits.

NCT ID: NCT03618953 Terminated - Clinical trials for HPV-Associated Cancers

This is a Trial of MG1-E6E7 With Ad-E6E7 and Atezolizumab in Patients With HPV Associated Cancers

Kingfisher
Start date: June 21, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase 1/1b open-label dose escalation trial of Ad/MG1-E6E7 and sequential treatment with atezolizumab in patients with HPV associated cancers. This study will consist of two arms. Both arms will dose escalate (MG1-E6E7) using a 3 + 3 design in Phase 1 to establish initial safety and the maximum tolerated dose (MTD) / maximum feasible dose (MFD). - Arm 1 - intravenous (IV) administration of MG1-E6E7 following intramuscular (IM) AD-E6E7 priming and subsequent treatment with IV atezolizumab. - Arm 2 - intratumoral (IT) and IV injection of MG1-E6E7 following (IM) Ad-E6E7 priming and subsequent treatment with IV atezolizumab. In the Phase 1b expansion for each arm, additional patients will be enrolled at the MTD as determined in Phase 1 in order to more thoroughly explore immune response, pharmacokinetics/dynamics, and safety for the patient populations with Cervical cancer, HPV positive (HPV+) Oropharyngeal cancer (Phase 1B, Arm 1, Cohorts A and B respectively) and HPV+ tumors with injectable lesions (Phase 1B, Arm 2, Cohort 3).

NCT ID: NCT03616821 Terminated - Ulcerative Colitis Clinical Trials

Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis

Expedition
Start date: August 7, 2018
Phase: Phase 2
Study type: Interventional

The present study (D5272C00001/Legacy #3151-201-008) aims to evaluate the efficacy and safety of brazikumab in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by improvement of symptoms and of colonic mucosal appearance as observed on endoscopy

NCT ID: NCT03615989 Terminated - Healthy Clinical Trials

The Combined Effect of Dairy and Exercise on Bone and Inflammation

Cre-Ex-Inf
Start date: October 1, 2018
Phase: N/A
Study type: Interventional

This study analyzes whether dairy supplementation positively impacts loading exercise-induced bone cell activity and inflammation in healthy young females.