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NCT ID: NCT01969838 Completed - Clinical trials for Primary Myelofibrosis

Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis

Simplify 1
Start date: December 6, 2013
Phase: Phase 3
Study type: Interventional

This study is to determine the efficacy of momelotinib (MMB) versus ruxolitinib (RUX) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (post-PV/ET MF) who have not yet received treatment with a Janus kinase inhibitor (JAK inhibitor). Participants will be randomized to receive either MMB or ruxolitinib for 24 weeks during a double-blind treatment phase, after which they will be eligible to receive open-label MMB for up to an additional 216 weeks. After discontinuation of study medication, assessments will continue for 12 additional weeks, after which participants will be contacted for survival follow-up approximately every 6 months for up to 5 years from the date of enrollment or until study termination. For those participants planning to continue treatment with MMB following the end of the study, the Early Study Drug Discontinuation (ESDD), 30-day, 12-Week, and survival follow-up visits are not required.

NCT ID: NCT01969747 Completed - Clinical trials for Diabetes Mellitus, Type 1

Empagliflozin add-on to Insulin in Type 1 Diabetes Mellitus Over 28 Days

Start date: November 2013
Phase: Phase 2
Study type: Interventional

Placebo-controlled, double blind (triple-dummy technique), randomised parallel design comparison of three oral doses (2.5 mg, 10 mg, and 25 mg) of empagliflozin in patients with T1DM as adjunctive therapy to insulin over 28 days. Patients will undergo a 14-day open-label placebo run-in period before randomisation. Background insulin therapy will be kept stable during the first 7 days of the treatment period and will be freely adjusted thereafter.

NCT ID: NCT01966419 Completed - Clinical trials for Hepatic Encephalopathy

Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)

STOP-HE
Start date: January 7, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.

NCT ID: NCT01965652 Completed - Clinical trials for Opioid-induced Constipation

Long Term Safety of Naldemedine

Start date: September 24, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety of naldemedine for the treatment of constipation due to opioid therapy.

NCT ID: NCT01965158 Completed - Clinical trials for Opioid-induced Constipation

Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation

Start date: August 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in subjects with non-malignant chronic pain who are not using laxatives

NCT ID: NCT01964443 Completed - Psoriasis Clinical Trials

Clinical Assessment and Psychosocial Impact of Psoriasis

EPIDEPSO
Start date: September 2013
Phase: Phase 4
Study type: Observational

The purpose of this study is to explore the impact of plaque psoriasis on the different dimensions of patient life including psychological disorders, different types of addictions, and their consequences on health-related quality of life and socioeconomic parameters at baseline (cross-sectional part) and during the initial years of the psoriasis disease (longitudinal part).

NCT ID: NCT01964430 Completed - Neoplasms Clinical Trials

Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)

apact
Start date: March 28, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare whether there is a delay or prevention of recurrence or death in participants with surgically removed pancreatic cancer who then take nab-Paclitaxel in combination with gemcitabine compared to those who take gemcitabine alone.

NCT ID: NCT01961817 Completed - Intubation Clinical Trials

Airway Management Via the Retromolar Route Access

Start date: July 2013
Phase: N/A
Study type: Interventional

Is there a difference in vocal cord visualization between the retromolar and conventional access?

NCT ID: NCT01961622 Completed - Type 1 Diabetes Clinical Trials

Closing the Loop in Adults With Sub-optimally Controlled Type 1 Diabetes Under Free Living Conditions

AP@home04
Start date: April 2014
Phase: N/A
Study type: Interventional

The main objective of this study is to determine whether day and night closed-loop insulin delivery for 12 weeks under free living conditions is superior to addition of real-time continuous glucose monitoring in adults with type 1 diabetes and sub-optimal glucose control on insulin pump therapy. This is an open-label, multi centre, randomised, crossover design study, involving a 6 to 8 week run-in period, during which glucose control will be optimised by a professional pump educator, followed by two 3 months study periods during which glucose levels will be controlled either by an automated closed-loop system or by subjects usual insulin pump therapy augmented with real-time continuous glucose monitoring in random order. A total of up to 42 adults (aiming for 30 completed subjects) aged 18 years and older with T1D on insulin pump therapy will be recruited through diabetes clinics and other established methods in participating centres. Subjects who drop out of the study within the first 6 weeks of the first intervention arm will be replaced. Subjects will receive appropriate training in the safe use of closed-loop insulin delivery system. Subjects will have regular contact with the study team during the home study phase including 24/7 telephone support. Subjects will be discouraged from international travel during the first two weeks of closed-loop use. The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM (adjusted for potential over-estimation) during home stay. Secondary outcomes are the HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics.

NCT ID: NCT01961102 Completed - Endometrial Cancer Clinical Trials

OSCAR ENDO One Stop Assessment of Risk for Endometrial Hyperplasia and Cancer

Start date: May 2013
Phase: N/A
Study type: Observational

It is to be achieved that in postmenopausal women through the combination of Hysteroscopy and intraoperative rapid section a positive predictive value (PPV) regarding the objective illness like endometrial cancer or adenomatous hyperplasia of 100% so as a negative predictive value (NPV) of 99%.