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NCT ID: NCT03200132 Suspended - Cardiac Imaging Clinical Trials

Respiratory Motion Correction of Cardiac Combined Positron Emission Tomography and Magnetic Resonance Imaging (PET/MRI)

Start date: June 26, 2017
Study type: Observational

This study evaluates the possibility of Magnetic Resonance Imaging (MRI) based respiratory motion correction of simultaneously acquired cardiac Positron Emission Tomography (PET) images.

NCT ID: NCT03150628 Suspended - Gastric Cancer Clinical Trials

Cytoreductive Surgery and Intraperitoneal Chemotherapy for Stomach CAncer: a Feasibility Study

Start date: August 1, 2017
Phase: Phase 2
Study type: Interventional

Rationale: For patients with peritoneal metastases of gastric origin, there is no consensus on the optimal treatment strategy. Several Asian and Western studies demonstrated hyperthermic intraperitoneal chemotherapy (HIPEC) and cytoreductive surgery (CS) to result in a prolonged survival compared to palliative systemic treatment. Morbidity and mortality rates of HIPEC and CS appear to be acceptable. In the Netherlands, this treatment is not yet introduced, therefore patients with peritoneal metastases of gastric origin are precluded from surgery and will be treated with palliative chemotherapy or best support of care. Objective: To assess the safety and feasibility of HIPEC and CS in Western patients with peritoneal metastases of gastric cancer, in terms of morbidity and mortality. Secondary objective is to determine the effect on survival and recurrence. Study design: Mono centre prospective phase II single-arm feasibility study. Study population: Western patients diagnosed with resectable (cT1-4b, N1-3) gastric cancer with clinical or pathologically proven peritoneal metastases without distant metastases. Intervention: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Cytoreductive Surgery (CS) with Cisplatin. Main study parameters/endpoints: Primary outcome is the safety and feasibility of the intervention, measured by the percentage of overall surgical complications grade ≥3 as stated by the Common Terminology Criteria for Adverse Events. Secondary outcomes are intraoperative events, postoperative morbidity and mortality, postoperative recovery, including quality of life, and disease free- and overall survival. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The additional burden for the patient mainly consists of HIPEC and CS.Furthermore, patients will undergo additional staging in order to exclude unresectable disease, and neoadjuvant chemotherapy regimen (3 drugs) instead of a palliative chemotherapy regimen (2 drugs). Postoperative care and outpatient visits are performed according to current protocols on HIPEC and CS for colon cancer and nation-wide protocols on gastric cancer surgery. The study is associated with a high risk classification. As there is a potential survival benefit, a small chance for curation and possibly a higher quality of life, we consider the additional burden and risks justified. This study is designed as a one group study, which eliminates group relatedness.

NCT ID: NCT03070574 Suspended - Colorectal Cancer Clinical Trials

Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome

Start date: November 24, 2017
Phase: Phase 2
Study type: Interventional

Multicenter, multinational, randomized, 3-arm, double-blind, phase II clinical study with 2400mg mesalamine, 1200mg mesalamine or placebo for prevention of colorectal neoplasia in Lynch Syndrome patients for 2 years.

NCT ID: NCT02775006 Suspended - Clinical trials for Carcinoma, Non-small Cell Lung

Docetaxel Versus Intercalated Erlotinib-docetaxel in Patients With Relapsed EGFR Wild Type, ALK Negative Non Squamous Cell Carcinoma

Start date: October 14, 2016
Phase: Phase 3
Study type: Interventional

The objective of this study is to investigate the effect of docetaxel monotherapy and the combination of docetaxel intercalated erlotinib in patients with relapsed EGFR wild type, ALK negative non squamous cell carcinoma.

NCT ID: NCT02656329 Suspended - Heart Failure Clinical Trials

International Study to Determine if AdreView Heart Function Scan Can be Used to Identify Patients With Mild or Moderate Heart Failure (HF) That Benefit From Implanted Medical Device

Start date: January 2016
Phase: Phase 3
Study type: Interventional

This is an event-driven Phase IIIb, multicentre, randomised, clinical study to demonstrate the efficacy of AdreView™ imaging for appropriately guiding the decision of implantable cardioverter defibrillator (ICD) implantation, in New York Health Association (NYHA) class II and III heart failure patients with 25%≤left ventricular ejection fraction (LVEF)≤35%, and in particular, for identifying patients who are at low risk for sudden cardiac death and who would not benefit, or may suffer harm, from implantation of an ICD device.

NCT ID: NCT02453035 Suspended - Clinical trials for Coronary Artery Stenosis

DESolve® X-Pand Global Post Market Registry

Start date: May 2015
Phase: N/A
Study type: Observational [Patient Registry]

The X-Pand Registry is intended to facilitate analysis of acute & long-term safety as well as treatment outcomes with DESolve in patients with CAD.

NCT ID: NCT02407795 Suspended - Spinal Metastases Clinical Trials

Conventional With Stereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases

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

A randomized, multicentre, phase III study comparing conventional radiotherapy (1x8Gy) with stereotactic radiotherapy (1x20Gy) for pain reduction and quality of life in spinal metastases.

NCT ID: NCT02361957 Suspended - Ulcerative Colitis Clinical Trials

The Effect of the Multispecies Probiotic Ecologic 825 Versus Placebo in Ulcerative Colitis Patients

Start date: November 2014
Phase: N/A
Study type: Interventional

RATIONALE: The underlying etiology in inflammatory bowel diseases such as Ulcerative Colitis is not yet fully understood. Studies suggest a relation between higher intestinal permeability and aberrant changes of the epithelium. Dysbiosis of the intestinal microbiota might be the cause. Probiotics may restore the balance of the intestinal microbiota. In theory this could improve intestinal permeability and therefore reduce disease activity and maintain remission in patients with Ulcerative Colitis. OBJECTIVE: To investigate whether a specifically designed multispecies probiotic mixture (ecologic 825®), as adjuvant therapy, can contribute to an improvement of intestinal permeability, microbiota composition, disease activity and inflammatory markers in ulcerative colitis. STUDY DESIGN: 12-wk placebo-controlled randomized double-blind intervention with 2 parallel arms. STUDY POPULATION: Adults diagnosed with left sided Ulcerative Colitis or Pancolitis in remission or mild stage of the disease. For inclusion of the patients the Patient Simple Clinical Colitis Activity Index (P-SCCAI) will be used. INTERVENTION: Patients will receive either two daily dosages of 3 g of Ecologic® 825 or two daily doses of 3 g of the placebo, containing only the carrier material (both produced by Winclove Probiotics). MAIN STUDY PARAMETERS/ENDPOINTS: Main study parameter is intestinal permeability measured by several techniques: the lactulose/mannitol absorption test (L/M test), LPS levels in blood serum and faecal zonulin. Secondary, inflammation will be measured from faecal calprotectin and blood c-reactive protein (CRP) levels. Furthermore samples will be stored to measure cytokine concentrations in serum and to analyse the microbial composition of the faecal samples using the HITchip. For the disease related quality of life the irritable bowel disease questionnaire (IBD-Q) and SF-36 will be used. All parameters will be measured at three time points; t=0, t=6 and t=12 weeks.

NCT ID: NCT02315937 Suspended - Hypotension Clinical Trials

Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography'

Start date: September 2016
Phase: N/A
Study type: Observational

Rationale: Spinal anesthesia is a safe, frequently used anesthetic technique. The main side effect of spinal anesthesia is hypotension, occuring in up to 85 % of selected cases. This hypotension is often treated with fluid infusion. However, especially in elderly patients, high volume fluid infusion can lead to fluid overload. The effects of spinal anesthesia on preload and fluid responsiveness are not exactly known. Hence, therapy for hypotension after spinal anesthesia might not be adequate. With transthoracic echocardiography, vena cava inferior diameter and collapsibility can be used to monitor fluid responsiveness and guide fluid management. Objective: This study has two main objectives. The first is to explore the effects of spinal anesthesia on hemodynamic parameters of fluid status, especially vena cava inferior diameter and collapsibility. The second goal is to test the interrater variability transthoracic echocardiography exams when performed by (trained) anesthesiologists. Furthermore, the correlation between vena cava inferior collapsibility and the occurence and degree of hypotension (defined as a decrease from baseline of >20% or a systolic pressure < 90 mmHg) after spinal anesthesia will be explored.

NCT ID: NCT02291289 Suspended - Colorectal Cancer Clinical Trials

A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC)

Start date: April 17, 2015
Phase: Phase 2
Study type: Interventional

This randomized, multi-center, active-controlled, open-label, parallel-group study will investigate the efficacy and safety of biomarker-driven maintenance treatment for first-line mCRC. Participants with mCRC are eligible for entry and cannot have received any prior chemotherapy in the metastatic setting. The entire study duration is anticipated to be approximately 7.5 years.