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NCT ID: NCT02426125 Completed - Clinical trials for Urothelial Carcinoma

A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer

RANGE
Start date: July 13, 2015
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the safety and efficacy of the study drug ramucirumab in combination with docetaxel in participants with urothelial cancer who failed prior platinum-based therapy.

NCT ID: NCT02424656 Completed - Clinical trials for Traumatic Brain Injury

Alterations in the Brain's Connectome After Severe Traumatic Brain Injury

ABCinTBI
Start date: September 2014
Phase:
Study type: Observational

This study explores the changes in whole-brain connectivity that occur during recovery from severe Traumatic Brain Injury and how these changes are related to the recovery of consciousness. Multimodal neuroimaging techniques will be used in a longitudinal fashion while patients are undergoing neurorehabilitation and after one-year of the TBI episode.

NCT ID: NCT02423850 Completed - Clinical trials for Diabetes Mellitus, Type 2

Three-dimensional Measurements of Diabetic Foot Ulcers

Start date: August 2015
Phase:
Study type: Observational

Diabetic foot ulcers constitute an increasing health problem in Denmark concurrent with an ageing population and an increase in diabetes prevalence. Diabetic foot ulcers belong to the most serious and costly complications. Several studies have found that the size and depth of the ulcer is one of the major etiologic factors for delayed healing. Wound measurement is important in the monitoring of the wound healing process. For the last decade different 3D (three-dimensional) techniques for measuring wounds have been proposed in order to measure wound volume, but none of the technologies have been widely used. A 3D Wound Assessment Monitor (WAM) camera has been developed, which is able to measure wound size in 3D and to assess wound characteristics. The investigators hypothesize that three-dimensional measurements of diabetic foot ulcers are feasible in the assessment of wound healing. A prospective cohort study is conducted in which newly admitted patients with a diabetic foot ulcer are included at the first visit at the multidisciplinary clinic. The patients are followed for one year or until complete wound healing, amputation or death. The four wound measurements: 2D area, 3D area, perimeter and volume are measured using the 3D-WAM camera with frequent intervals. Patient anthropometrics and wound data are collected during the study and correlated to the wound healing.

NCT ID: NCT02422849 Completed - Clinical trials for Acute Medical Conditions

Acute Combined Care for Seniors in Southern Denmark

ACCESS
Start date: November 2013
Phase: N/A
Study type: Interventional

the elderly population (+ 65 years) is increasing. Acute medical conditions often leads to hospital admissions in this age group. However hospital admission is linked to adverse events. like confusion, medication errors or new infections. the ACCESS project aims to examine alternatives to acute admissions for senior medical patients. the aims are: 1. How many patients will be admitted to hospital due to acute medical conditions if cared for by their own General Practitioner (GP) versus a hospital intern specialist ? 2. how many patients will be admitted to hospital due to acute medical conditions if cared for by acute team in their home versus in specialised care centres ?

NCT ID: NCT02422615 Completed - Clinical trials for Advanced Breast Cancer

Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.

MONALEESA-3
Start date: June 9, 2015
Phase: Phase 3
Study type: Interventional

The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.

NCT ID: NCT02422589 Completed - Clinical trials for ALK-positive Advanced Tumors

A Phase I, Multi-center, Open Label, Drug-drug Interaction Study to Assess the Effect of Ceritinib on the Pharmacokinetics of Warfarin and Midazolam in Patients With ALK-positive Advanced Tumors

Start date: October 23, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study was to evaluate the potential inhibitory effects of ceritinib on the CYP3A4- and CYP2C9-mediated metabolism of the probe drugs midazolam and warfarin, respectively, when administered simultaneously as a cocktail. The results obtained from this drug interaction study would provide guidance that would enable an update to the ceritinib labeling and ouldl help guide recommendations for administration of co-medications in future clinical trials.

NCT ID: NCT02422316 Completed - Clinical trials for Coronary Artery Disease

Non-contrast Cardiac CT as a Risk Stratification Tool in Patients With Non-cardiac Chest Pain

Start date: September 2014
Phase: N/A
Study type: Observational

Background: Only around 20% of all patients seen in hospital with suspected Acute Coronary Syndrome will have Acute Myocardial Infarction. However, several studies indicate that patients where ACS had been excluded by conventional methods sustain a higher cardiac morbidity and mortality than the background population. Not all of these patients can be identified by traditional risk factors such as cholesterol, hypertension, and diabetes or with conventional methods such as ECG, troponin and clinical symptoms. Non-Contrast Cardiac-CT measures the amount of calcification in the coronary arteries and might be a useful addition in predicting future cardiac events in this patient group. The aim of this study is through a double-blinded study to determine whether non-contrast CT scan with calcium score can be used to identify patients at increased risk of death and cardiac event within the following 12 months after an acute admission where troponin measurements were normal. Methods: The study will investigate patients with suspected Acute Coronary syndrome who have been examined and subsequently sent home from an emergency- or cardiology department without ACS or another obvious explanation. 750 patients, age 30-70 years who are included in the study: "Identification of risk factors in non-cardiac chest pain patients" will be offered a non-contrast CT scan with calcium score within 14 days after the hospital contact. The participants will be included in a 12 months follow up, where the result of the calcium score is not revealed neither for the patient nor the investigator. After 12 months the results of the scan is compared with the rate of cardiac events. This project is a multicenter study and recruits patients from 6 emergency - and cardiology departments in the region of Southern Denmark. The study commences at September 2014 and results of this project are expected to contribute to the risk stratification of Non-cardiac chest pain patients.

NCT ID: NCT02422108 Completed - Infertility Clinical Trials

TNFSF11 Inhibition and Fertility: a Prospective Study

Start date: May 2015
Phase: Phase 2
Study type: Interventional

The receptor activator of NF-kB ligand (RANKL) system is considered important for bone homeostasis and comprises three important factors. RANKL exist in three isoforms but the predominant function is mediated by the transmembrane ligand that binds to a specific receptor (receptor activator of NF-KB (RANK)) on a neighbour cell that subsequently activates NFKB and regulates cell cycle OPG is an endogenous secreted protein that binds RANKL and inhibits its signalling. Thus, the RANK/RANKL system is vital for activation of the bone resorbing cells (osteoclasts). In bone the bone synthesizing cells (osteoblasts) express RANKL that signals to RANK on the immature osteoclasts. This induces proliferation and activation of the cells they start to proliferate and resorp bone. OPG is produced by somatic cells in the bone and this production is regulated by sex hormones, TGF-B and various other substances. Today a human made recombinant antibody against RANKL, Denosumab is used to treat osteoporosis as it inhibits RANKL signalling and thus causes less bone resorption in humans. RANKL, RANK and OPG are expressed in the testis and this pathway appears to be a novel regulator of germ cell proliferation. Decreased semen quality is a major factor of male infertility. Semen quality is a measure of the ability of the sperm to accomplish fertilization. Evaluation of male fertility potential is today basically conducted through semen analysis. There is no treatment for men with no sperm in the ejaculate and there exist no drug that can increase sperm counts.Therefore, drugs that can lower RANKL expression/activity for instance an antibody against RANKL such as Denosumab may be used for this new indication: A new treatment option of infertile men with impaired semen quality.

NCT ID: NCT02421172 Completed - Clinical trials for Hidradenitis Suppurativa (Acne Inversa)

Efficacy, Safety, and Pharmacokinetics Study of CJM112 in Hidradenitis Suppurativa Patients

Start date: April 13, 2015
Phase: Phase 2
Study type: Interventional

This is a randomized, double blind, multicenter study in patients with moderate to severe chronic hidradenitis suppurativa in parallel groups, to determine the efficacy and safety of multiple doses of CJM112 in comparison to placebo. The study has two periods to explore preliminary dose effects.

NCT ID: NCT02420821 Completed - Clinical trials for Renal Cell Carcinoma

A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC)

IMmotion151
Start date: May 20, 2015
Phase: Phase 3
Study type: Interventional

This multi-center, randomized, open-label study will evaluate the efficacy and safety of atezolizumab plus bevacizumab versus sunitinib in participants with inoperable, locally advanced, or metastatic RCC who have not received prior systemic active or experimental therapy, either in the adjuvant or metastatic setting.