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NCT ID: NCT03345485 Completed - Ovarian Cancer Clinical Trials

Study of the Safety, Pharmacokinetics and Efficacy of EDO-S101, in Patients With Advanced Solid Tumors

Start date: October 6, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Tinostamustine (EDO-S101) is a new chemical entity, an AK-DAC (a first-in-class alkylating deacetylase inhibiting molecule), that in pre-clinical studies has been shown to simultaneously improve access to the DNA strands within cancer cells, break them and block damage repair. This Phase 1/2 study will enroll patients with various advanced solid tumors.

NCT ID: NCT03345095 Completed - Clinical trials for Newly Diagnosed Glioblastoma

A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma

MIRAGE
Start date: July 26, 2018
Phase: Phase 3
Study type: Interventional

The standard of care for newly diagnosed glioblastoma includes surgery, involved-field radiotherapy, and concomitant and six cycles of maintenance temozolomide chemotherapy, however the prognosis remains dismal. Marizomib has been tested in patients with newly diagnosed and recurrent glioblastoma in phase I and phase II studies. In patients with recurrent glioblastoma, marizomib was administered as a single agent or in combination with bevacizumab (NCT02330562). Based on encouraging observations, a phase I/II trial of marizomib in combination with Temozolomide+Radiotherapy(TMZ/RT) followed by Temozolomide (TMZ) in newly diagnosed glioblastoma has been launched (NCT02903069) which explores safety and tolerability of this triple combination and which shall help to determine the dose for further clinical trials in glioblastoma. In this context, given that marizomib has been established as a safe addition to the standard TMZ/RT -->TMZ, a phase III study is considered essential to establishing its impact on overall survival.

NCT ID: NCT03344159 Completed - Clinical trials for Pulmonary Arterial Hypertension

Spironolactone Therapy in Chronic Stable Right HF Trial

STAR-HF
Start date: April 1, 2018
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and mechanistic effects of spironolactone, an aldosterone receptor antagonist, on sympathetic nervous system activity and right heart function and remodeling in patients with chronic right heart failure.

NCT ID: NCT03342495 Completed - Stroke Clinical Trials

Evaluating Innovations in Transition From Pediatric to Adult Care - The Transition Navigator Trial

TNT
Start date: February 6, 2018
Phase: N/A
Study type: Interventional

The Transition Navigator Trial (TNT) is a pragmatic randomized controlled trial evaluating the effectiveness of usual care plus a patient navigator service versus usual care plus newsletters and other educational materials, to improve transition outcomes among adolescents aged 16-21 who have chronic health conditions requiring transfer to adult specialty care. The study will provide urgently needed data to guide health care providers and policy makers regarding the provision of coordinated transition care. These results have the potential to: 1. Change care delivery 2. Improve health outcomes 3. Improve the experiences of young adult transition to adult care

NCT ID: NCT03342183 Completed - Clinical trials for Chronic Kidney Disease

Reducing Hemodialysis Induced Recurrent Brain Injury to Improve Patients' Lives

Start date: January 8, 2018
Phase: N/A
Study type: Interventional

Patients who receive dialysis for kidney failure suffer severe cognitive impairment. Hemodialysis causes circulatory stress and ischemia, which causes severe brain injury. It has been demonstrated that a procedure known as Remote Ischemic Preconditioning(RIPC), which involves wrapping a blood pressure cuff around a patient's leg and inflating has the potential of protecting many organs, such as the heart from the effects of dialysis. Our study aims to investigate this phenomenon to determine the extent to which it provides protection to a dialysis patient's brain.

NCT ID: NCT03342053 Completed - Clinical trials for Huntington's Disease

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7234292 (ISIS 443139) in Huntington's Disease Patients Who Participated in Prior Investigational Studies of RO7234292 (ISIS 443139)

Start date: January 2, 2018
Phase: Phase 2
Study type: Interventional

This study will test the safety, tolerability, pharmacokinetics and pharmacodynamics of RO7234292 administered intrathecally to adult patients with Huntington's Disease.

NCT ID: NCT03339297 Completed - Clinical trials for Graft-versus-host Disease

An Open-Label Study of Defibrotide for the Prevention of Acute Graft-versus-Host-Disease (AGvHD)

Start date: February 21, 2018
Phase: Phase 2
Study type: Interventional

This is a study comparing the defibrotide prophylaxis arm vs standard of care arm for the prevention of aGvHD.

NCT ID: NCT03339167 Completed - Healthy Men Clinical Trials

Metabolic Availability of Lysine From Millet in Adult Men

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

Protein is the key determinant of growth and bodily functions. The quality of food proteins depend on their amino acid content and the amount of amino acids used by the body to make proteins. Globally Cereal Grains (CG) provide 50% of the calories and protein in the diet and exceed 80% in poorer developing countries. In many of those countries, millet is the major cereal grain in the diet. The protein in millet is low in the essential amino acid lysine. Hence millet protein is of low quality. Low lysine affects protein synthesis in the body. Cooking methods also affect the lysine available from foods to the body.The protein can be complemented by the addition of lentils to augment the low lysine content. However, lentils are prohibitively expensive in some developing countries. As the human population increases, the world faces the continuous challenge of maximizing a limited food supply. Protein quality (PQ) evaluation of millet directly in humans would allow us to bridge the gap in knowledge between what is required and how best to provide.The information gathered from this project will provide the first direct experimental data on PQ of millet protein in humans on which nutrition recommendations can be built.

NCT ID: NCT03339154 Completed - Healthy Clinical Trials

Metabolic Availability of Methionine From Chickpeas in Adult Men

Start date: August 4, 2017
Phase: N/A
Study type: Interventional

The research study is being done so we can determine the quality of the protein present in Canadian chickpeas. Amino acids are the building blocks of protein and protein quality is determined by the amount of amino acids present and by their bioavailability (their absorption and use by the body). Some amino acids are essential which means they must be obtained from the diet. If any one of the essential amino acids is missing in the diet, the body cannot make proteins that are used to repair tissue build bone, teeth, etc…Chickpeas as a food source contain low amounts of the essential amino acid methionine which makes its protein incomplete. The amino acids in chickpeas are also affected by cooking. Our objective is to determine the amount of methionine in chickpeas that the body can use. We will test chickpeas by studying them after cooking them, on their own and by combining the chickpeas with rice in a mixed meal to make a more complete protein. This research is being done in order to bridge the gap between knowledge of protein requirement and the amount of food needed to meet that requirement. Results from this study will be important for recommendations guiding food choices of chickpeas as a major protein source in the diet. Previously the quality of dietary protein for human consumption was studied in animals. This study is being done in humans because studies in animals are not directly applicable to humans. Excessive animal protein consumption is also linked to cardiovascular disease. Plant protein sources like chickpeas are important alternatives shown to "enhance ecosystem resilience, and improve human health.

NCT ID: NCT03338816 Completed - Clinical trials for Acute Intermittent Porphyria

ENVISION: A Study to Evaluate the Efficacy and Safety of Givosiran (ALN-AS1) in Patients With Acute Hepatic Porphyrias (AHP)

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

The purpose of this study is to evaluate the effect of subcutaneous givosiran (ALN-AS1), compared to placebo, on the rate of porphyria attacks in patients with Acute Hepatic Porphyrias (AHP).