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NCT ID: NCT03828838 Completed - Prostate Neoplasm Clinical Trials

Lutetium-177-PSMA-617 in Low Volume Metastatic Prostate Cancer

Start date: July 1, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Radioligand therapy (RLT) using Lu-177 labelled PSMA is a promising new therapeutic approach to treat metastatic prostate cancer. This tumor-specific treatment is directed against prostate-specific membrane antigen (PSMA), which is overexpressed in prostate cancer cells. In the last few years, several lutetium-177 (177Lu, β emitter) labeled PSMA ligands have been developed and are currently applied to treat metastatic castrate resistant prostate cancer (mCRPC) patients. However, there are no prospective studies published so far using this treatment approach in hormone sensitive setting. In this pilot study patients with hormone sensitive prostate cancer who did not undergo hormonal treatment will be treated with Lu-177 PSMA-617.

NCT ID: NCT03827018 Completed - Clinical trials for Giant Cell Arteritis

KPL-301 for Subjects With Giant Cell Arteritis

Start date: September 20, 2018
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of mavrilimumab (KPL-301) versus placebo, co-administered with a 26-week corticosteroid taper, for maintaining sustained remission for 26 weeks in subjects with new onset or relapsing/refractory giant cell arteritis (GCA).

NCT ID: NCT03824821 Completed - Clinical trials for Irritable Bowel Syndrome

Assessing Associations Between IBS Symptoms, Nutrition and QoL in IBS Patients Using a Questionnaire

IBSQUtrition
Start date: January 22, 2018
Phase:
Study type: Observational

This study is a cross-sectional observational study design that aimed to include 2000 IBS patients. We used several validated questionnaires, to assess IBS characteristics (such as subtype, severity), psychological features (QoL, anxiety and depression) and assess nutritional triggers. Subjects filled in the questionnaire online, and was spread across the Netherlands.

NCT ID: NCT03824418 Completed - Ulcerative Colitis Clinical Trials

The Clinical Value of Chromoendoscopy as Surveillance Strategy for Dysplasia Detection in Ulcerative Colitis

Start date: May 9, 2016
Phase:
Study type: Observational [Patient Registry]

A recent multicentre randomised controlled trial compared autofluorescence imaging (AFI) with CE for dysplasia detection in colonoscopy surveillance of patients with longstanding UC (FIND-UC). In this study, CE detected significantly more dysplastic lesions per patient compared with AFI. It is unclear whether this increased dysplasia detection also translates to a reduction of dysplasia at follow-up colonoscopy. The aim of this pre-specified study is therefore to prospectively determine whether there is a difference in dysplasia detection at follow-up colonoscopy between UC patients who were randomized to AFI or CE at index colonoscopy for the FIND-UC trial.

NCT ID: NCT03824080 Completed - Clinical trials for Acute Myeloid Leukemia

Evaluating the Efficacy and Safety of Bemcentinib in Patients With Myelodysplastic Syndromes

Start date: December 20, 2018
Phase: Phase 2
Study type: Interventional

This is an open-label, single-arm multicenter, phase II study. The primary objective is to assess the efficacy of bemcentinib (BGB324) a highly selective inhibitor of the AXL receptor tyrosine kinase for the treatment of AML and MDS patients failing or being refractory to first line hypomethylating agent (HMA) treatment. Furthermore, safety, disease progression, treatment failure will be assessed. A total of 43 patients will be included in the trial.

NCT ID: NCT03823404 Completed - Alzheimer Disease Clinical Trials

GAIN Trial: Phase 2/3 Study of COR388 in Subjects With Alzheimer's Disease

Start date: March 28, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled study that assessed the efficacy, safety, and tolerability of 2 dose levels of COR388 in subjects with a clinical diagnosis of mild to moderate Alzheimer's disease (AD) dementia.

NCT ID: NCT03823391 Completed - Clinical trials for Rheumatoid Arthritis (RA)

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)

Start date: March 27, 2019
Phase: Phase 2
Study type: Interventional

This study will assess the safety, tolerability, and efficacy of ABBV-3373 in participants with moderately to severely active rheumatoid arthritis (RA) on background methotrexate (MTX) compared with adalimumab.

NCT ID: NCT03823287 Completed - Clinical trials for Wet Macular Degeneration

A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (TENAYA)

Start date: February 19, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).

NCT ID: NCT03823222 Completed - Clinical trials for Degree of Digestilbility

Proteins From Duckweed Trial

ProDuckT
Start date: February 28, 2019
Phase: N/A
Study type: Interventional

This study aims to study the digestibility of isolated duckweed protein. The digestibility of the isolated duckweed protein will be compared to an isolated benchmark protein whey. Objective: The primary objective is to investigate the digestibility of isolated duckweed protein and the isolated benchmark protein whey. Study design: The study is a cross-over, double blind, controlled trial in which study participants will visit the research facility on two occasions under fasting conditions. Subjects will receive two protein sources in randomized order with a washout period of one week. Blood will be collected via a catheter before and up-to 3 hours after protein consumption. Study population: We aim to include 12 healthy volunteers aged 18-50 years. Intervention: Study participants will receive 20 grams of isolated duckweed protein and the isolated benchmark protein whey. Main study parameters/endpoints: The main study parameter is blood amino acids measured before and after consumption of 20 g protein.

NCT ID: NCT03822390 Completed - Clinical trials for Artificial Intelligence

Diagnostic Performance of a Convolutional Neural Network for Diminutive Colorectal Polyp Recognition

POLAR
Start date: October 16, 2018
Phase:
Study type: Observational

Rationale: Diminutive colorectal polyps (1-5mm in size) have a high prevalence and very low risk of harbouring cancer. Current practice is to send all these polyps for histopathological assessment by the pathologist. If an endoscopist would be able to correctly predict the histology of these diminutive polyps during colonoscopy, histopathological examination could be omitted and practise could become more time- and cost-effective. Studies have shown that prediction of histology by the endoscopist remains dependent on training and experience and varies greatly between endoscopists, even after systematic training. Computer aided diagnosis (CAD) based on convolutional neural networks (CNN) may facilitate endoscopists in diminutive polyp differentiation. Up to date, studies comparing the diagnostic performance of CAD-CNN to a group of endoscopists performing optical diagnosis during real-time colonoscopy are lacking. Objective: To develop a CAD-CNN system that is able to differentiate diminutive polyps during colonoscopy with high accuracy and to compare the performance of this system to a group of endoscopist performing optical diagnosis, with the histopathology as the gold standard. Study design: Multicentre, prospective, observational trial. Study population: Consecutive patients who undergo screening colonoscopy (phase 2) Main study parameters/endpoints: The accuracy of optical diagnosis of diminutive colorectal polyps (1-5mm) by CAD-CNN system compared with the accuracy of the endoscopists. Histopathology is used as the gold standard.