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NCT ID: NCT02540395 Completed - Clinical trials for Disorder Related to Renal Transplantation

Prospective Donor Specific T Response Measurment for IS Minimization in de Novo Renal Transplantation

Start date: March 2015
Phase: N/A
Study type: Interventional

The main objective of the study is to demonstrate the utility and safety of the IFN-γ (Interferon Gamma) ELISPOT (Enzyme-linked immunosorbent spot) marker for the stratification of kidney transplant recipients into low and high IS (Immunosuppression) regimens. The enrichment study will test non-inferiority of low IS regimen compared to high IS regimen, assuming 10% of BPAR at 6-months in the control group, and allowing a non-inferiority limit of maximum 10%.

NCT ID: NCT02539927 Completed - Acromegaly Clinical Trials

Validation Study of the SAGIT® Instrument in Acromegaly

SAGIT
Start date: July 2015
Phase:
Study type: Observational

Patients will be treated in accordance with the standard medical practice of the hospital where they have been recruited during their participation in this study. No additional assessments or tests will be required. SAGIT® is a new instrument developed by a group of acromegaly experts to help practicing endocrinologists to manage acromegalic patients and disease activity in their clinical practice and define acromegaly staging. It reports 5 elements: Signs and symptoms - S; Associated comorbidities - A; Growth hormone (GH) concentration - G; Insulin-like growth factor 1(IGF-1) concentration -I; Tumour size- T. The instrument has been pre evaluated during a qualitative pilot study. The purpose of the validation study is to define and validate the scoring of the SAGIT® instrument.

NCT ID: NCT02539641 Completed - Morbid Obesity Clinical Trials

Bariatric Procedures and Changes in Incretins and Gastric Emptying

BIG
Start date: April 2015
Phase: N/A
Study type: Interventional

The study evaluates the gastric emptying by scintigraphy in patients that had bariatric surgery (RYGB of gastric sleeve) comparing patients with successful and unsuccessful weight loss and in patients before and after the placement of a duodenal-jejunal bypass liner. Additional, after bariatric surgery gut hormones that influence the gastric emptying rate are determined.

NCT ID: NCT02539368 Completed - Ulcerative Colitis Clinical Trials

Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease

CONNECT-IBD
Start date: April 22, 2015
Phase:
Study type: Observational

This is a post-marketing observational study of patients with Inflammatory Bowel Disease (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed CT-P13 (infliximab) or Remicade (infliximab) for treatment. CT-P13 (brand names Inflectra and Remsima) is a biosimilar medicine to Remicade, meaning it is a biologic medicine that contains the same active substance as Remicade (infliximab). The key study objectives are as follows: - To characterize the population and drug utilization patterns of patients treated with CT-P13 for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade - To explore the long-term safety profile of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade - To assess the effectiveness of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade

NCT ID: NCT02538666 Completed - Lung Cancer Clinical Trials

An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy

CheckMate 451
Start date: October 13, 2015
Phase: Phase 3
Study type: Interventional

In this study, all patients must have already completed first-line chemotherapy to treat extensive-stage disease small cell lung cancer. The purpose of this study is to show that nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall survival when administered as consolidation treatment in patients that are stable or responding after chemotherapy. Patients receiving treatment will be compared with patients taking placebo.

NCT ID: NCT02538354 Completed - Crohn Disease Clinical Trials

The Effect of Riboflavin in Crohn's Disease

RISE-UP
Start date: March 2016
Phase: N/A
Study type: Interventional

This study will evaluate if suppelementation of the diet with riboflavin in Crohn's disease patients will result in an increase in the amount of F. prausnitzii.

NCT ID: NCT02538211 Completed - Tetanus Clinical Trials

The Role of the Intestinal Microbiome in Enteric and Systemic Vaccine Immune Responses

Rota-biome
Start date: September 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate if the intestinal microbiota influences rotavirus vaccine immune responses in healthy adult volunteers.

NCT ID: NCT02537951 Completed - Clinical trials for Small Fiber Neuropathy

Autofluorescent Flavoprotein Imaging of Intraepidermal Nerve Fibers: a Pilot Study

Start date: September 2015
Phase: N/A
Study type: Interventional

Small fiber neuropathy (SFN) is a common disorder, which has a profound negative impact on quality of life because of severe neuropathic pain. To reliably establish a diagnosis of SFN is challenging, since neurological examination and nerve conduction studies are often normal. Autofluorescent flavoprotein imaging (AFI) is an optical method through which neuronal activity in the termination area of small nerve fibers in the spinal cord can be quantified. Since the epidermis also contains a high density of small nerve terminals and since the number of intraepidermal nerve fibers is greatly reduced in patients with SFN, our hypothesis is that AFI intensity is reduced in patients with SFN. To support this hypothesis, a pilot study is required in which the investigators first need to confirm the precision of AFI in the epidermis of the third finger of 10 healthy volunteers. Secondly, lidocaine/prilocaine cream will be used as a negative control. Finally, the AFI signal will be measured after application of a 8% capsaicin patch, through which (temporarily) a selective reduction of small nerve fibers can be induced, mimicking SFN. Using this experimental design, the investigators will be able to test the reliability and validity of AFI for capsaicin-induced small nerve fiber degeneration. This would be a significant step in developing an objective, rapid and non-invasive diagnostic tool to diagnose patients with SFN, which may also be utilized as a biomarker in studies that assess the efficacy of novel treatments for SFN.

NCT ID: NCT02537691 Completed - Asthma Clinical Trials

Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers

Start date: August 28, 2015
Phase: Phase 4
Study type: Interventional

Prospective, single-arm, longitudinal, international, multicenter study in a real-world cohort of adult severe asthma participants being conducted to assess the relationships between asthma biomarkers and asthma-related health-outcomes for a period of 52 weeks.

NCT ID: NCT02536196 Completed - Clinical trials for Symptomatic Aortic Stenosis

The REFLECT Trial: Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation

Start date: June 2016
Phase: N/A
Study type: Interventional

The Keystone Heart TriGuard™ HDH is an aortic embolism deflection device intended to reduce the amount of embolic material that may enter the carotid, subclavian, and vertebral arteries during transcatheter heart valve implantation. The objective of the study is to assess the safety and efficacy of the TriGuard™ HDH embolic deflection device in patients undergoing transcatheter aortic valve implantation (TAVI), in comparison with an active control group of patients undergoing unprotected TAVI. Subjects with indications for TAVI and who meet study eligibility criteria will be randomized 2:1 to one of two treatment arms: 1) Intervention: Embolic protection device (TriGuard™) with transcatheter aortic valve implantation or 2) Control: Unprotected transcatheter aortic valve implantation.