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NCT ID: NCT03941080 Recruiting - Clinical trials for Colorectal Cancer Metastatic

Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer

GIMICC
Start date: September 9, 2020
Phase:
Study type: Observational

In this study the characteristics and alterations of the gut microbiome during chemotherapy for metastasized or irresectable CRC are studied, as well as the relation between the gut microbiome and the effects of chemotherapy.

NCT ID: NCT03940846 Active, not recruiting - Clinical trials for Nonsmall Cell Lung Cancer

CT-based Radiomic Signature Can Identify Adenocarcinoma Lung Tumor Histology

Start date: March 1, 2019
Phase:
Study type: Observational

Lung cancer remains the leading cause of cancer related mortality worldwide, with more than 1.5 million related deaths annually. Lung cancer is divided into two main groups: Small Cell Lung Carcinoma (SCLC) and Non-Small Cell Lung Carcinoma (NSCLC), with prevalence of ~20% and 80% respectively. NSCLC is further subdivided into adenocarcinoma (the most common), squamous cell carcinoma (SCC), and large cell carcinoma. Furthermore, each subtype is likely to have specific mutations, which could be targeted for treatment. Medical imaging and radiomics feature extraction represent a candidate alternative to conventional tissue biopsy, a theory that is investigated in this study.

NCT ID: NCT03940703 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer

A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)

Start date: September 19, 2019
Phase: Phase 2
Study type: Interventional

This study was to assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic non-small cell lung cancer (NSCLC).

NCT ID: NCT03940196 Completed - Ovarian Cancer Clinical Trials

Effect of Tumor Treating Fields (TTFields, 200 kHz) Concomitant With Weekly Paclitaxel for the Treatment of Recurrent Ovarian Cancer (ENGOT-ov50 / GOG-3029 / INNOVATE-3)

Start date: March 22, 2019
Phase: Phase 3
Study type: Interventional

The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of Tumor Treating Fields (TTFields) concomitant with weekly paclitaxel for the treatment of recurrent ovarian cancer . The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

NCT ID: NCT03939273 Not yet recruiting - Clinical trials for Coronary Artery Disease

The Effects of Gut Micribiota Disruption on the Immune Response After Open Heart Surgery

REMEDI
Start date: March 2022
Phase: N/A
Study type: Interventional

In this randomized, double-blind, placebo-controlled study, the investigators will assess whether preoperative disruption of the gut microbiota by a course of broad spectrum antibiotics will attenuate the postoperative systemic inflammatory response after on-pump cardiac surgery

NCT ID: NCT03938701 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

Fluorescence Imaging of IBD and RA Using Adalimumab-800CW

STRATIFY
Start date: June 2023
Phase: Phase 1
Study type: Interventional

Inflammatory bowel disease (IBD) and rheumatoid arthritis (RA) are both auto-immune diseases that are characterized by chronic relapsing inflammation of respectively the ileocolonic tissue and the synovium. Pathogenesis of both auto-immune diseases is attributed to the proinflammatory cytokine tumor necrosis factor α (TNFa). Adalimumab is a human monoclonal anti-TNF antibody used for treating patients with moderate to severely active IBD and RA. However, current rates of therapeutic nonresponsiveness to this antibody are variable and difficult to predict in advance, whereas patients are potentially exposed to a non-effective treatment and its potential side effects; while clinical deterioration progresses. A key unmet need is the development of a predictive tool for assessment of a therapeutic (non-) response to patients and finding an optimal dose strategy in individual patients before initiating anti-TNF therapy. Unfortunately, we currently lack crucial information about drug distribution of the drug of interest throughout the targeted inflamed tissue itself. Therefore, it remains unknown in both IBD and RA, if the drug reaches its target (in sufficient amounts) and how local drug concentrations are related to therapeutic response. Thus, we linked adalimumab to a fluorescent dye (adalimumab-800CW) in order to create a fluorescent signal of the labelled drug in the diseased tissue that we can visualize and quantify with dedicated optical fluorescence imaging systems. We hypothesize that this tracer will bind to TNFa in the mucosa/synovium and thus create a map of medicine distribution in vivo due to colocalization of the fluorescent labelled compound. Therefore, the aim of this study is to assess the feasibility of fluorescent molecular imaging of adalimumab-800CW in IBD and RA patients.

NCT ID: NCT03938168 Recruiting - Chronic Pain Clinical Trials

Histological and Molecular Mechanisms of Pain in Patient With Chronic Pain From Adhesions

PAIN PAD
Start date: April 9, 2019
Phase:
Study type: Observational

11-20% of patients undergoing abdominal surgery develop chronic abdominal pain. Adhesions are a common cause of chronic pain following surgery. Adhesions develop after up to 90% of laparotomies and 70% of laparoscopic surgeries. Obviously, not all adhesions cause pain. It is still poorly understood why adhesions cause pain in some patients, while other patients with adhesions experience no pain. In this study we explore possible mechanism through which adhesions might cause pain. For this purpose we will assess expression of molecular mediators (such as TRPV-1, SP, and the neurokinin receptor), histological characteristics, and fecal microbioma that might be associated with pain.Expression of these factor will be compared to sample from 30 patients with chronic pain attributed to adhesions, and 30 patients undergoing a reoperation with adhsiolysis for reasons unrelated to pain.

NCT ID: NCT03937609 Recruiting - Colitis, Ulcerative Clinical Trials

TITRATE (inducTIon for acuTe ulceRATivE Colitis)

TITRATE
Start date: September 4, 2019
Phase: Phase 4
Study type: Interventional

The aim of this study is to investigate whether intensive, personalized IFX dosing by using a pharmacokinetics driven dashboard system during the induction phase in patients with acute severe UC leads to increased treatment success (as defined by clinical and endoscopic response at week 6) as compared to the standard dosing.

NCT ID: NCT03937375 Completed - Surgery Clinical Trials

Re-Evaluation of the Effects of High PEEP During General Anesthesia For Surgery (REPEAT)

REPEAT
Start date: January 1, 2019
Phase:
Study type: Observational

Aiming to understand the isolated impact of high PEEP in patients undergoing mechanical ventilation for general anesthesia for surgery, three appropriately sized international multicentre randomized controlled trials have been performed over recent years: the 'PROtective Ventilation using HIgh versus LOw PEEP trial (PROVHILO), the 'individualized PeRioperative Open-lung Ventilation trial' (iPROVE), and the 'Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients trial' (PROBESE). These three trials had several similarities in key areas of their study protocols, inclusion and exclusion criteria, and collected data, and even the primary and secondary outcomes. Of note, the three trials combined high PEEP with recruitment manoeuvres. This allows an individual patient data meta-analysis.

NCT ID: NCT03937219 Active, not recruiting - Clinical trials for Renal Cell Carcinoma

Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

COSMIC-313
Start date: June 25, 2019
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blinded, controlled Phase 3 trial of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in combination with matched placebo. Approximately 840 eligible subjects with intermediate- or poor-risk advanced or metastatic RCC by IMDC criteria will be randomized in a 1:1 ratio at approximately 180 sites.