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NCT ID: NCT03247907 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

Humidification Needs

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

A study undertaken to investigate mouth leak for airway discomfort/dryness while using CPAP. This study will also measure how much humidification is required to treat subsequent upper airway discomfort/dryness from mouth leak by utilizing different levels and types of humidification.

NCT ID: NCT03233360 Recruiting - Clinical trials for Hepatocellular Carcinoma

Hepatocellular Carcinoma Registry in Asia

Start date: April 17, 2017
Phase: N/A
Study type: Observational

This registry is designed as a multi-centre longitudinal cohort study of patients diagnosed with HCC between 1st January 2013 and 30th June 2018 in nine countries (ie, Korea, Taiwan, Thailand, Japan, China, Hong Kong, Australia, New Zealand and Singapore). Approximately 30% of the sample size will be identified retrospectively and 70% will be identified prospectively from the start date of the registry (October 2016), with an even distribution of consecutively diagnosed patients within the different years.

NCT ID: NCT03225287 Recruiting - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria (PNH)

Extension Study of RA101495 for Patients With PNH Who Have Completed a RA101495 Clinical Study

Start date: July 17, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to enable continued access to RA101495 for patients with paroxysmal nocturnal hemoglobinuria (PNH) after they complete a RA101495 clinical study.

NCT ID: NCT03221426 Not yet recruiting - Gastric Cancer Clinical Trials

Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)

Start date: August 24, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS), event-free survival (EFS) and pathological complete response (pathCR) rate.

NCT ID: NCT03216005 Enrolling by invitation - Clinical trials for Chronic Venous Insufficiency

Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System

INFINITE-OUS
Start date: July 2017
Phase: N/A
Study type: Interventional

To evaluate the safety and effectiveness of the BlueLeaf System for the restoration of venous competence for the treatment of symptomatic chronic venous insufficiency (CVI).

NCT ID: NCT03214367 Recruiting - Clinical trials for Type 1 Diabetes Mellitus

A Study of LY900014 in Participants With Type 1 Diabetes

PRONTO-T1D
Start date: July 17, 2017
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy of the study drug LY900014 compared to insulin lispro, both in combination with insulin glargine or insulin degludec, in adults with type 1 diabetes (T1D).

NCT ID: NCT03199053 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Study to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients With Type 2 Diabetes Mellitus Aged 10 to Below 18 Years Old

Start date: August 31, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this research study is to evaluate the efficacy and safety of the drugs dapagliflozin and saxagliptin in patients with Type 2 Diabetes who are aged 10 to below 18 years old and are currently taking metformin, insulin, or both drugs. Dapagliflozin and saxagliptin are both approved for use in patients with Type 2 Diabetes aged 18 years or older. This study will assess how well dapagliflozin and saxagliptin work by finding out how these treatments affect blood glucose (sugar) levels compared to placebo (a pill that contains no active drug), in children and adolescents. Dapagliflozin and saxagliptin are considered investigational products in this study since while they have been approved for use in adults (patients 18 years or older), they haven't been approved for children and adolescents due to lack of clinical studies in this specific population. Patients with Type 2 Diabetes have higher levels of blood glucose (sugar) than patients who do not have this disease. The high level of sugar in the blood can lead to serious short-term and long-term medical problems. The main goal of treating diabetic patients is to lower blood glucose to a normal level. Lowering and controlling blood glucose help prevent or delay complications of diabetes, such as heart disease, kidney, eye and nerve diseases, and the possibility of amputation. Dapagliflozin is a drug that helps to reduce blood glucose (sugar) levels by helping the kidneys to remove excess glucose from the blood and excrete it in the urine. It prevents the kidneys from returning glucose from the urine back into the bloodstream. Saxagliptin increases insulin production when blood glucose levels are high. Insulin is a hormone made by the pancreas that allows the body to use sugar (glucose) from the food that is eaten for energy or to store glucose for future use. Saxagliptin helps to improve blood sugar levels in response to a meal and between meals if blood glucose levels are not lowered effectively. Saxagliptin does not work when the blood glucose is low. Saxagliptin also helps to decrease the amount of sugar made by the body. Together, these processes reduce blood glucose levels and help to control Type 2 Diabetes. Dapagliflozin (alone or in combination with other antidiabetic drugs) has been shown to be effective in lowering blood glucose in adults with Type 2 Diabetes and is available for use in adults (patients 18 years or older) in approximately 40 countries worldwide including the USA and Europe. Dapagliflozin has not yet been studied in children (pediatric patients). Saxagliptin (alone or in combination with other antidiabetic drugs) has been shown to be effective in lowering blood glucose in adults with Type 2 Diabetes and is available for use in adults (patients 18 years or older) in approximately 90 countries worldwide. Saxagliptin also has not yet been studied in children (pediatric patients). The subject will either receive one of the active study drugs or a placebo (a pill that looks identical but contains inactive drug). This study will be double blind; this means that neither the subject, nor the study doctor will know which treatment the subject will receive. Which treatment the subject receives is decided by a computer, purely by chance; this is called a "random assignment". For this study, there will first be a screening phase of up to 6 weeks, followed by a 2 week lead in phase. Thereafter there will be a 26 week short-term treatment phase (week 1-week 26), and a 26 week long-term treatment phase (week 27-week 52). Following this there will be a follow-up telephone call on week 56 and a post study visit at week 104. At day 1 visit after the lead in phase the subject will be randomly assigned to receive one of 3 treatments: dapagliflozin 5 mg, saxagliptin 2.5 mg or placebo in a blinded manner. This treatment will continue up to week 14. Then after week 14, and until the end of the study, the subject will be assigned to receive one of the following 5 treatments: dapagliflozin 5 mg, dapagliflozin 10 mg, saxagliptin 2.5 mg, saxagliptin 5 mg or placebo in a blinded manner. The drugs assigned after week 14 will be the same drugs as at Day 1, but some of the groups will receive them at a higher dose. After completion of the 26-week short-term phase, the subject will enter a 26 week long-term phase. The same treatment that the subject had been assigned to at week 14 visit will be continued. This long-term phase is primarily designed to provide additional information on how well dapagliflozin and saxagliptin are tolerated. Following the treatment phases, there will be a follow-up telephone call at week 56. The subject will be asked to visit the clinic at week 104 again for a final evaluation of the physical development (based on the stage of puberty).

NCT ID: NCT03193281 Not yet recruiting - Clinical trials for Chronic Myeloid Leukemia

KISS Study: Kinase Inhibition With Sprycel Start up

KISS
Start date: July 2017
Phase: Phase 2
Study type: Interventional

Chronic myeloid leukaemia (CML) is due to a chromosomal abnormality in white blood cells which results in abnormal multiplication. CML in its earlier, slower growing chronic phase (CP) is well controlled by the tyrosine kinase inhibitor (TKI) drug imatinib, which targets the consequences of the chromosomal abnormality, inducing a response and subsequent remission (as measured using molecular techniques on patient blood or bone marrow samples in the lab). Dasatinib, a newer TKI drug, similar in design to imatinib, gives a more rapid molecular response, however the long term side-effects are less known than imatinib. This study will investigate the efficacy and safety of a treatment plan for patients with newly diagnosed CML-CP, where dasatinib will be used to more rapidly induce a molecular response (MR3.0) within 12 months, after which imatinib will be used to maintain the CML in that remission. It is hypothesised that imatinib is safe and effective in maintaining MR3.0 in patients with CML who achieve MR3.0 at 12 months following initial induction therapy with dasatinib.

NCT ID: NCT03181633 Recruiting - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

A Long-term Treatment Study of ACH-0144471 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Start date: June 22, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate long term safety and efficacy of ACH-0144471 in patients with PNH who have demonstrated clinical benefit from ACH-0144471 in Clinical Study ACH471-100. This study is designed to include up to 12 patients.

NCT ID: NCT03171155 Not yet recruiting - Clinical trials for Percutaneous Closure of Arteriotomy in Common Femoral Artery

Clinical Study of the Medeon Biodesign XPro™

Start date: May 30, 2017
Phase: N/A
Study type: Interventional

To access the safety and performance of the XPro System to facilitate hemostasis in patients undergoing percutaneous endovascular procedures utilizing 8-18 Fr introducer sheath via the common femoral.