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NCT ID: NCT03689374 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes

SUSTAIN 11
Start date: October 1, 2018
Phase: Phase 3
Study type: Interventional

This study will compare the effect of semaglutide once weekly to insulin aspart 3 times daily as add on to metformin and insulin glargine in people with type 2 diabetes. Participants will either get insulin glargine and semaglutide or insulin glargine and insulin aspart - which treatment the participant get is decided by chance. Insulin glargine is taken once a day and semaglutide once a week. Insulin aspart is taken three times per day before a meal. All three medicines come in pre-filled pens for injection under the skin. The study will last for about 71 weeks. If participant's blood sugar gets under or over certain values participant will only participate in 14 weeks. The study doctor will inform the participant about this. The participant will have 15 clinic visits and 22 phone calls with the study doctor.

NCT ID: NCT03619967 Recruiting - Breast Cancer Clinical Trials

Sentinel Lymph Node Mapping With Near Infrared Fluorescent Markers

Start date: July 20, 2018
Phase: N/A
Study type: Interventional

Surgery is the primary curative option for patients with cancer, with the overall objective of complete resection of all cancerous tissue while avoiding damage to healthy tissue. In addition, sentinel lymph node (SLN) mapping and resection is an essential step in staging and managing the disease. Even with the latest advancements in imaging technology, incomplete tumor resection in patients with breast cancer is at an alarming rate of 20-25%, with recurrence rates of up to 27%. The clinical need for imaging instruments that provide real-time feedback in the operating room is unmet, largely due to the use of imaging systems based on contemporary technological advances in the semiconductor and optical fields, which have bulky and costly designs with suboptimal sensitivity and co-registration accuracy between multimodal images. To address these challenges, the investigators have introduced an innovative design comprising a bio-inspired multispectral sensor which can significantly improve image-guided surgery. The objective of this clinical study is to determine the feasibility of using a bio-inspired multispectral imaging system to detect sentinel lymph nodes and cancerous tissue during intraoperative procedures in patients with breast cancer.

NCT ID: NCT03552250 Active, not recruiting - Clinical trials for Child Mental Disorder

Prevention of Child Mental Health Problems in Southeastern Europe

RISE
Start date: April 26, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to develop an adapted version of a low-cost parenting program (Parenting for Lifelong Health for Young Children, PLH) to the specific needs of families in three low- and middle income countries (LMICs) in southeastern Europe (Romania, FYR of Macedonia and Republic of Moldova). The investigators want systematically evaluate key barriers and facilitators at the local, national and international levels that impact prevention of child behavioral disorders. The investigators will prepare training materials adapted to Romanian, Moldovian, Albanian, Macedonian, and Russian and train facilitators and mentor coaches in the delivery of the PLH program in each country. Also, a pre-post study will be conducted testing the feasibility of the program and the evaluation and implementation methods with 40 families at each country site. This includes examination of outcomes related to implementation fidelity, program acceptability, and preliminary program effectiveness on reducing child behavior problems and associated risk factors. This feasibility study is part of a larger implementation project. Developed on the MOST framework (the multiphase optimization strategy), this specific study will reflect the implementation of the first phase. There are two more phases to come: the Parenting for Lifelong Health for Young Children program will be optimized within the three countries by determining which components are most efficacious and cost-effective (phase 2). The optimized PLH programs will be tested in three RCTS in the countries (phase 3).

NCT ID: NCT03504228 Recruiting - Clinical trials for Carotid Artery Stenosis

Observational Study to Confirm Safety and Efficacy of the ROADSAVER Stent for the Treatment of Carotid Artery Stenosis

ROADSAVER
Start date: January 23, 2018
Phase:
Study type: Observational

Approximately 2000 patients eligible for elective treatment with a Carotid Stent according to hospital routine practice in centers across Europe will be enrolled in the study. The maximum number of patients enrolled at each site will be not limited. Follow-ups are scheduled at discharge, 30 days, and 1 year, as per local practice. Each patient will have follow-up contacts via hospital visit and/or telephone.

NCT ID: NCT03485911 Recruiting - Clinical trials for Hereditary Angioedema

Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE

APeX-2
Start date: February 6, 2018
Phase: Phase 3
Study type: Interventional

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of oral BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II HAE.

NCT ID: NCT03472040 Recruiting - Clinical trials for Hereditary Angioedema

A Long Term Safety Study of BCX7353 in Hereditary Angioedema

APeX-S
Start date: February 16, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This is an open-label study to evaluate the long term safety and effectiveness of oral treatment with BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II HAE.

NCT ID: NCT03466411 Recruiting - Crohn's Disease Clinical Trials

A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

GALAXI
Start date: April 13, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this program is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.

NCT ID: NCT03456076 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer

Start date: August 16, 2018
Phase: Phase 3
Study type: Interventional

This randomized, active-controlled, multicenter, open-label, Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting. Participants in the experimental arm will receive alectinib at 600 mg orally twice daily (BID) taken with food for 24 months. Participants in the control arm will receive one of the protocol specified platinum based chemotherapy regimens for 4 cycles. Following treatment completion, participants will be followed up for their disease until disease recurrence. At the time of disease recurrence, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier.

NCT ID: NCT03337724 Recruiting - Breast Cancer Clinical Trials

A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

IPATunity130
Start date: January 6, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2−) breast adenocarcinoma who are not suitable for endocrine therapy.

NCT ID: NCT03315143 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk

SCORED
Start date: November 28, 2017
Phase: Phase 3
Study type: Interventional

Primary Objectives: To demonstrate that, when compared to placebo in patients with type 2 diabetes (T2D), cardiovascular (CV) risk factors, and moderately impaired renal function, sotagliflozin: - Does not increase the risk of cardiovascular events including death from cardiovascular disease, non-fatal heart attack and non-fatal stroke; - Reduces the risk of death from CV disease or hospitalization for heart failure. Secondary Objectives: - To demonstrate that, when compared to placebo in patients with T2D, CV risk factors, and moderately impaired renal function, sotagliflozin: - Reduces cardiovascular events including death from cardiovascular disease, non-fatal heart attack and non-fatal stroke; - Reduces risk of progression of kidney disease; - Reduces cardiovascular events including death from cardiovascular disease and emergency treatment for heart failure; - Reduces death from cardiovascular disease; - Reduces death from any cause. - To assess the safety and tolerability of sotagliflozin.