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NCT ID: NCT03554681 Completed - Pre-Eclampsia Clinical Trials

Prediction of Preeclampsia (PE) at 11-13 Week

Start date: December 2016
Phase:
Study type: Observational

This is an international multicentre prospective cohort study to validate the Bayes theorem based algorithms for the screening of pre-eclampsia (PE) in the first-trimester of pregnancy.

NCT ID: NCT03553563 Completed - Gastric Ulcer Clinical Trials

A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer

Start date: July 24, 2018
Phase: Phase 3
Study type: Interventional

This is an open label, parallel group, multi-centre, phase III study to assess the safety and efficacy of D961H in maintenance therapy following initial healing therapy in Japanese paediatric patients with reflux esophagitis, and to assess the safety and efficacy of D961H in Japanese paediatric patients treated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy who have a documented medical history of gastric ulcer or duodenal ulcer diagnosis. Doses of D961H in this study is set for the 2 groups (weight more than equal 10 kg to less than 20 kg and weight more than equal 20 kg) in the maintenance therapy for healed reflux esophagitis group and the prevention of gastric ulcer or duodenal ulcer recurrence by non-steroidal anti-inflammatory drugs or low-dose aspirin therapy group, Primary endpoints are evaluated at week 32. Further, this study is designed to evaluate the long term efficacy and safety of D961H for a maximum of 52 weeks, in consideration of the medical needs for long term proton pump inhibitor treatment. Patient can continue study treatment up to 52 weeks, if they want

NCT ID: NCT03552757 Completed - Obesity Clinical Trials

Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity

STEP 2
Start date: June 4, 2018
Phase: Phase 3
Study type: Interventional

This study will look at the change in the participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the study medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what else the participant can do to lose weight. Overweight and obesity is associated with an increased risk of type 2 diabetes. Therefore, weight loss has shown to have a beneficial impact on the blood sugar levels. The participant will either get semaglutide or "dummy" medicine - which treatment the participant get is decided by chance. The participant will need to take 2 injections at the same time once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 1.5 years

NCT ID: NCT03551626 Completed - Malignant Melanoma Clinical Trials

Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes

COMBI-APlus
Start date: August 29, 2018
Phase: Phase 3
Study type: Interventional

The main purpose of this study was to evaluate the impact on pyrexia-related outcomes of an adapted pyrexia adverse event (AE)-management algorithm, as well as safety, efficacy and health-related outcomes.

NCT ID: NCT03551496 Completed - Clinical trials for Critical Limb Ischemia

The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia

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

Single phased global, prospective, multicenter clinical trial designed to demonstrate a superior patency rate and acceptable safety in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs. percutaneous transluminal angioplasty (PTA).

NCT ID: NCT03550989 Completed - Clinical trials for Environmental Exposure

Real-Life Passive Exposure Assessment of IQOS

Start date: December 5, 2017
Phase:
Study type: Observational

This study is a non-interventional observational study designed to assess the impact of passive exposure to IQOS environmental tobacco aerosol in Non-Smokers in a real-life restaurant setting.

NCT ID: NCT03550820 Completed - Energy Metabolism Clinical Trials

Energy Metabolism for the Patients With Pulmonary Mycobacterium Avium Complex

Start date: May 1, 2018
Phase:
Study type: Observational

We aim to examine energy metabolism in patients with pulmonary MAC and clarify the causes of emaciation. We will also investigate the following: the relation between energy metabolism and degree of pulmonary MAC progression; relations among hospitalization, mortality rate, and time-course of changes in energy metabolism; and factors that affect energy metabolism.

NCT ID: NCT03549871 Completed - Hemophilia Clinical Trials

A Study of Fitusiran in Severe Hemophilia A and B Patients Previously Receiving Factor or Bypassing Agent Prophylaxis

ATLAS-PPX
Start date: July 25, 2018
Phase: Phase 3
Study type: Interventional

Primary Objective: To characterize the frequency of bleeding episodes (BE) while receiving fitusiran treatment, relative to the frequency of bleeding episodes while receiving factor concentrate or bypassing agent (BPA) prophylaxis. Secondary Objectives: - To characterize the following while receiving fitusiran treatment, relative to receiving factor or BPA prophylaxis: - the frequency of spontaneous bleeding episodes - the frequency of joint bleeding episodes - health related quality of life (HRQOL) in participants greater than or equal to (>=) 17 years of age - To characterize the frequency of bleeding episodes during the onset and treatment periods in participants receiving fitusiran. - To characterize the safety and tolerability of fitusiran. - To characterize the annualized weight-adjusted consumption of factor/BPA while receiving fitusiran treatment, relative to receiving factor or BPA prophylaxis.

NCT ID: NCT03548935 Completed - Clinical trials for Overweight or Obesity

STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

STEP 1
Start date: June 4, 2018
Phase: Phase 3
Study type: Interventional

This study will look at the change in participants' body weight from the start to the end of the study. The weight loss in participants taking semaglutide (a new medicine) will be compared to the weight loss of participants taking "dummy" medicine. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what you can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get, is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study has two phases: A main phase and an extension phase.The main phase will last for about 1.5 years. Participants will have 15 clinic visits and 10 phone calls with the study doctor. Extension phase: Approximately 300 participants will continue in the extension phase in the following countries only: Canada, Germany, the UK and selected sites in the US and Japan. These participants will be in the study for about 2.5 years.They will not receive treatment, but will attend another 5 follow-up visits with the study doctor.

NCT ID: NCT03548220 Completed - Clinical trials for Pyruvate Kinase Deficiency

A Study to Evaluate Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD)

Start date: August 9, 2018
Phase: Phase 3
Study type: Interventional

Study AG348-C-006 evaluated the efficacy and safety of orally administered AG-348 as compared with placebo in participants with pyruvate kinase (PK) deficiency, who were not regularly receiving blood transfusions. Participants were randomized 1:1 to receive either AG-348 or a matching placebo.