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NCT ID: NCT01671644 Completed - Infertility Clinical Trials

Eeva™ Pregnancy Investigational Clinical Study: A Postmarket Follow-Up Study

EPIC
Start date: February 2013
Phase: N/A
Study type: Observational

The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates.

NCT ID: NCT01671007 Completed - Stroke Clinical Trials

GLORIA-AF Registry Program (Phase II/III - EU/EEA Member States)

Start date: August 22, 2012
Phase:
Study type: Observational

In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events. For administrative purposes the study is divided into two protocol numbers: 1160.129 for non-EU (European Union) and non-EEA (European Economic Area) countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in both protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.

NCT ID: NCT01669499 Completed - Bone Metastases Clinical Trials

Dexamethasone for Pain Flare After Radiotherapy of Painful Bone metastasesZonMW 11510009

Start date: January 2012
Phase: Phase 3
Study type: Interventional

Cancer patients with pain due to bone metastases are often treated with external irradiation in order to reduce pain. However, patients may experience a temporary increase of pain shortly after irradiation, a so-called pain flare. This study investigates whether a short course of a drug called dexamethasone may prevent the occurrence of a pain flare. Patients, who are irradiated for painful bone metastases are randomized into three groups. Group 1 receives placebo during four days, group 2 receives dexamethasone on the day of the irradiation and placebo during three days, and group 3 receives dexamethasone during four days. All patients complete a questionnaire on pain, side-effects of treatment and quality of life during 14 days and after four weeks. This study will define whether dexamethasone decreases the occurrence of a pain flare after irradiation for painful bone metastases, and, if so, whether four days of treatment with dexamethasone is better dan one day of treatment.

NCT ID: NCT01669174 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD) With Cachexia

BYM338 in Chronic Obstructive Pulmonary Disease (COPD) Patients With Cachexia

Start date: September 2012
Phase: Phase 2
Study type: Interventional

This study will assess the pharmacodynamics, pharmacokinetics, safety and tolerability of BYM338 in patients with COPD and cachexia. The primary outcome will be a change in thigh muscle volume compared to placebo. The study will last for approximately 24 weeks.

NCT ID: NCT01669070 Completed - Asthma Clinical Trials

A Four-way Crossover, Single and Repeat Dose Study to Determine the Dose Proportionality and Absolute Bioavailability of Fluticasone Furoate Inhalation Powder Administered by Novel Dry Powder Inhaler (NDPI)

Start date: August 15, 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to demonstrate dose proportionality of the FF (50 microgram (mcg), 100 mcg or 200 mcg), when administered as a single and repeat dose from the NDPI containing FF formulated with lactose. In addition, the aim of this study is to determine the absolute bioavailability of the FF single strip product using the high strength product administered as a single dose with multiple inhalations and using 250 mcg intravenous (IV) FF. This is a, part-randomized, open-label, 4 way crossover study (4 periods) in healthy adult subjects. During each period, subjects will receive FF in the morning and serial pharmacokinetic (PK) sampling (for up to 10 days for the inhaled treatment and up to 3 days for the IV treatment) and safety assessments will be performed. Each period will be separated by a washout period of at least 7 days and a follow-up telephone call will occur 7 -14 days after the last dose of study drug. The total duration of the study will be approximately 13-14 weeks for each subject.

NCT ID: NCT01667861 Completed - Glaucoma Clinical Trials

Risk Factors for Glaucoma in Musicians

Start date: October 2011
Phase: N/A
Study type: Observational

The purpose of this study is to determine the impact of playing wind instruments for the development of ocular hypertension and glaucoma, together with investigating the prevalence of visual problems and eye diseases in (professional) musicians.

NCT ID: NCT01667705 Completed - Anxiety Clinical Trials

To Examine the Effect of a View of Nature on Patient's Stress and Anxiety

Skyceiling
Start date: March 2012
Phase: N/A
Study type: Observational

- Rationale: Recently, research that demonstrates a clear relationship between the built healthcare environment and the health and wellbeing of patients has come available. Patients in a CT scan suite are usually anxious. The environment has been shown to lower stress; a painting or piece of art for example, can capture and hold attention and thereby lower negative thoughts and evoke positive emotions. Sights of nature have demonstrated to be especially effective in recuperating from stress, presumably because the human brain has evolved in a natural environment. The current study will investigate the effects of exposure to nature in the CT scan suite. A SkyCeiling, a large, slightly illuminated, photographic illusion of a real sky view is placed above the CT scan. The main hypothesis of this study is that a sky view will lead to a lower level of anxiety in the CT scan suite. - Objective: The primary objective of this study is to examine the effect of a view of nature on a patient's stress and anxiety. Secondary objectives are to study the effects of a view of nature on a patient's environmental appraisals of the CT suite, satisfaction with the provided service, and trust in the healthcare provider.

NCT ID: NCT01667536 Active, not recruiting - Prostate Cancer Clinical Trials

A Phase 2 Diagnostic Imaging Study With 99mTc-MIP-1404 in Men With High-Risk Prostate Cancer Scheduled for Radical Prostatectomy (RP) and Extended Pelvic Lymph Node Dissection (EPLND) Compared to Histopathology

Start date: August 2012
Phase: Phase 2
Study type: Interventional

This is a single arm, open label study of approximately 100 high-risk prostate cancer patients scheduled for prostatectomy and extended pelvic lymph node dissection. Patients receive a single IV dose of 99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours after injection. As standard of care, patients will undergo prostatectomy and extended pelvic lymph node dissection (EPLND) within three weeks of study drug dosing. 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.

NCT ID: NCT01667523 Completed - Healthy Clinical Trials

The Effect of Capsaicin and Cinnamaldehyde on Intestinal Permeability

Start date: February 2011
Phase: N/A
Study type: Interventional

An altered permeability has been proposed to play an important role in the pathogenesis of several gastrointestinal disorders, such as irritable bowel syndrome and inflammatory bowel disease. Nutrients derived from food are able to influence the permeability of the intestine and can therefore also affect gastrointestinal symptoms. In this study, the investigators will investigate the effects of capsaicine and cinnamaldehyde, which can be found in hot peppers and cinnamon, respectively, on gastrointestinal physiology. Objective: To obtain more information about the effects of capsaicin and cinnamaldehyde on the intestine, these substances will be infused directly in the duodenum. Hereafter, the permeability of the intestine, gallbladder motility and the effects on satiety will be assessed. Hypothesis: Duodenal capsaicin and cinnamaldehyde infusion induces changes in the intestinal epithelial barrier function by selectively acting on TRPV1 and TRPA1 receptors and releasing serotonin from enterochromaffin cells as determined by the multi sugar permeability test

NCT ID: NCT01667419 Completed - Melanoma Clinical Trials

A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma

BRIM8
Start date: September 24, 2012
Phase: Phase 3
Study type: Interventional

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF mutation-positive melanoma at high risk for recurrence. Participants will be enrolled in two separate cohorts: Cohort 1 will include participants with completely resected Stage IIC, IIIA (participants with one or more nodal metastasis greater than [>] 1 millimeter [mm] in diameter), or IIIB cutaneous melanoma, as defined by the American Joint Committee on Cancer (AJCC) Classification, Version 7; Cohort 2 will include participants with Stage IIIC cutaneous melanoma, as defined by this classification scheme. Within each cohort, participants will be randomized (1:1 ratio) to receive vemurafenib or matching placebo over a 52-week period.