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NCT ID: NCT02106546 Completed - Clinical trials for Squamous Non-Small Cell Lung Cancer

Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer

Start date: April 10, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of the addition of veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and paclitaxel in adults with advanced or metastatic squamous non-small cell lung cancer (NSCLC).

NCT ID: NCT02105948 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Study to Evaluate Efficacy and Safety of Mepolizumab for Frequently Exacerbating Chronic Obstructive Pulmonary Disease (COPD) Patients

Start date: April 15, 2014
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, placebo-controlled, double-blind, parallel group trial evaluating mepolizumab 100 mg against placebo given every 4 weeks through subcutaneous (SC) injection. In severe COPD patients, sputum eosinophils levels are elevated similar as those seen in severe asthmatics. It is hypothesized that the reduction of eosinophils with mepolizumab in COPD patients would translate into a reduction of COPD exacerbations. The study will determine the reduction in exacerbations in subjects who are above and below the baseline blood eosinophil count of at least 150 cells/microlitres. The study will evaluate the efficacy and safety of mepolizumab on the frequency of moderate and severe exacerbations in COPD subjects at high risk of exacerbations, despite the use of optimized standard of care background therapy. Overall in this study, a total of 800 subjects will be randomised in 1:1 ratio to receive placebo or mepolizumab (100 milligram (mg)) administered SC. The total duration of this study will be approximately 62 weeks, consisting of a 1 to 2 week screening period, 52-week treatment period and 8-week follow-up period.

NCT ID: NCT02105259 Completed - Clinical trials for Social Anxiety Disorder

Internet-delivered Psychodynamic Therapy for Social Anxiety Disorder (SOFIA)

SOFIA
Start date: March 2014
Phase: N/A
Study type: Interventional

The overall aim of this study is to develop and test a psychodynamic Internet--delivered psychological treatment for patients with social anxiety disorder and compare its efficacy to a waiting list.

NCT ID: NCT02104947 Completed - Hemorrhage Clinical Trials

Reversal of Dabigatran Anticoagulant Effect With Idarucizumab

Start date: May 6, 2014
Phase: Phase 3
Study type: Interventional

Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.

NCT ID: NCT02104089 Completed - Aortic Aneurysm Clinical Trials

Post-market Observational Study Zenith® t-Branchâ„¢

Start date: January 2014
Phase:
Study type: Observational

The Zenith® t-Branchâ„¢ Thoracoabdominal Endovascular Graft Study is a post-market observational study to evaluate the performance of the Zenith® t-Branchâ„¢ in the treatment of thoracoabdominal aortic aneurysms in routine care.

NCT ID: NCT02103205 Active, not recruiting - Clinical trials for Infant Infections in Formula-fed Children

Effect of Infant Formula With Bovine Lactoferrin and Low Iron Concentration on Infant Health and Immune Function

LIME
Start date: June 2014
Phase: N/A
Study type: Interventional

Breast milk is the gold standard of early infant nutrition and breastfed infants have advantages in several short and long term outcomes compared to those formula-fed. The first aim of this study is to evaluate the effect of adding bovine lactoferrin to infant formula. The general hypothesis is that bovine lactoferrin reduces some of the previously observed differences between formula-fed and breast-fed infants with regard to health and development. The main outcome studied is the effect on immune function. The second aim is to study the effects of lower iron concentration in infant formula and to test the hypothesis that iron can be lowered without negative effects on health and development. The main outcome studied here is iron status. Other outcomes in this trial are microbiota composition, metabolomics, growth, body composition and cognitive development. To test the lactoferrin hypothesis, formula-fed infants will be recruited and fed a low iron (2 mg/L) control formula, or the same formula supplemented with bovine lactoferrin. To test the iron hypothesis, a third group will be fed the same formula (no lactoferrin) with higher iron concentration (8 mg/L). Group allocation for all formula-fed infants will be double-blind randomized. Additionally, breast-fed infants will be recruited and used as a reference group (gold standard).

NCT ID: NCT02102503 Completed - Clinical trials for Coronary Heart Disease

Motivational Interviewing and Medication Review in Coronary Heart Disease

MIMeRiC
Start date: October 2013
Phase: N/A
Study type: Interventional

Low medication adherence in patients with coronary heart disease increases mortality. This study investigates if an intervention of medication review and counselling can improve patients' medication adherence and treatment results.

NCT ID: NCT02102477 Recruiting - Prostatic Neoplasms Clinical Trials

Surgery Versus Radiotherapy for Locally Advanced Prostate Cancer

SPCG-15
Start date: October 2014
Phase: N/A
Study type: Interventional

This prospective, open randomized phase III surgical trial seeks to study whether radical prostatectomy (with or without the combination of external radiation) improves prostate-cancer specific survival in comparison with primary radiation treatment and hormonal treatment among patients diagnosed with locally advanced (T3) prostate cancer. Untreated or conservatively treated locally advanced prostate cancer is associated with high mortality. Modern curative treatment for advanced solid malign tumors include surgery and/or radiation plus attempted chemotherapy if available to achieve both local control and elimination of potential micro metastases. Whereas there is evidence that surgery can cure localized prostate cancer, there are no clinical trials of multi-modal treatment of locally advanced prostate cancer that includes surgical removal of the prostate. One potential advantage of adding prostatectomy to the treatment of LAPC is that removing the prostate enables a full pathological assessment of the tumor characteristics and thus a better estimation of the risk of recurrence. Surgical treatment could thus reduce the numbers needed to treat with chemotherapy and radiation, and thus improve quality of life after treatment. In addition, evidence indicate that residual cancer in the prostate occurs in 25% after radiation treatment (56) and surgical removal of the prostate may improve survival beyond what can be achieved by radiation and ADT. On the other hand, patients treated with surgery, radiation and hormones will experience side effects of all three treatment modalities and might fare better if radiotherapy plus hormones can provide oncological control without prior surgery. A randomized clinical trial comparing two multimodal treatment regimens of which one includes a radical prostatectomy is therefore warranted.

NCT ID: NCT02102334 Completed - Clinical trials for Osteoarthritis of the Hip

Validity, Reliability and Reproducibility of Plain Radiographic Measurements After Total Hip Arthroplasty

Start date: September 2010
Phase: N/A
Study type: Observational

In total hip arthroplasty (THA), radiographic preoperative planning and postoperative evaluation of acetabular component, femoral offset (FO) and leg length discrepancy (LLD) require good validity, interobserver reliability and intraobserver reproducibility. Questions/purposes: (1) Evaluate the validity of the Sundsvall method of FO measurement by comparing it to a standard FO measurement method. (2) Evaluate the interobserver reliability and intraobserver reproducibility of measurement of FO, LLD, acetabular cup inclination and anteversion. 90 patients with primary unilateral osteoarthritis (OA) were included in this prospective study. On postoperative radiographs FO by the Sundsvall method, FO by a standard method, LLD, acetabular cup inclination and anteversion were measured. The interobserver reliability and intraobserver reproducibility were made by three independent observers. The validity and degree of prediction of Sundsvall method are measured by comparing its results with the standard method.

NCT ID: NCT02102204 Completed - Clinical trials for Hyperparathyroidism, Secondary

Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis

Start date: March 25, 2014
Phase: Phase 3
Study type: Interventional

This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on hemodialysis.