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NCT ID: NCT02932501 Active, not recruiting - Clinical trials for Bisphosphonate-Associated Osteonecrosis of the Jaw

Medication-related Osteonecrosis of the Jaw (MRONJ) Registry

MRONJ
Start date: August 14, 2017
Phase:
Study type: Observational [Patient Registry]

Approximately 500 patients will be included in this patient registry. Data collection includes demographics, clinical data of underlying disease and use of bisphosphonates, denosumab and antiangiogenic drugs , degree and extension of osteonecrosis, osteonecrosis-specific treatment, outcomes and complications within 1 year after treatment.

NCT ID: NCT02931942 Active, not recruiting - Myeloma Clinical Trials

Changing Over Time of Ascorbic Acid After Chemotherapy

Start date: September 1, 2016
Phase:
Study type: Observational

Rationale: Recent studies showed that ascorbic acid (AA) stimulates proliferation and maturation of T lymphocytes and NK cells. Chemotherapy results in depletion of those cells and thereby an increased infection rate. A pilot study showed low levels of AA in the plasma of several patients after chemotherapy for hematological malignancies. AA suppletion could be beneficial to the recovery of the immune system in these patients. But before an intervention study can be undertaken, further understanding of changing over time of AA levels and the relationship with the immune status after chemotherapy is necessary. Objective: The aim of this pilot study is to evaluate the changing over time of AA levels in plasma and in leukocytes before and during chemotherapy treatment for several different groups of patients and compare that to healthy controls. In this way we want to identify the patients were further interventions could be useful and use the data in the development of an intervention study for power calculations and to identify the primary endpoint. Study design: observational study Study population: There will be 6 different groups of participants in the study: two groups of patients that receive clinical intensive chemotherapy (acute leukemia and high dose chemotherapy with autologous stem cell rescue), two groups of patients that receive relatively mild chemotherapy in outpatient setting (colon cancer and lung cancer) and two control groups. All participants will be adults and recruited at the MUMC+. In total there will be 150 participants. Main study parameters/endpoints: Influence of chemotherapy on AA levels in plasma and in leukocytes.

NCT ID: NCT02931890 Active, not recruiting - Gastric Cancer Clinical Trials

Multicentric Randomised Trial for Resectable Gastric Cancer

CRITICS-II
Start date: December 21, 2017
Phase: Phase 2
Study type: Interventional

The CRITICS-II trial aims to identify the optimal preoperative regimen in resectable gastric cancer by comparing three investigational treatment arms: chemotherapy vs. chemotherapy and subsequent chemoradiotherapy vs. chemoradiotherapy. The rationale behind this trial design is based on the following concepts: - Preoperative treatment is associated with better patient compliance than postoperative regimens - Preoperative treatment increases the likelihood of disease downsizing/downstaging and radical R0 resections - Preoperative paclitaxel/carboplatin-based concurrent chemoradiotherapy and DOC chemotherapy are effective, feasible and safe regimens

NCT ID: NCT02931045 Completed - Clinical trials for Myocardial Infarction

Antiplatelet Therapy Effect on Extracellular Vesicles in Acute Myocardial Infarction

AFFECT EV
Start date: December 30, 2017
Phase: Phase 4
Study type: Interventional

Platelet activation and aggregation leads to myocardial infarction. Platelet P2Y12 receptors are essential for platelet activation. Antagonists against the P2Y12 receptor, which are established in secondary prevention of myocardial infarction, have unexplained anti-inflammatory effects. A novel P2Y12 receptor antagonist ticagrelor reduced infection-related mortality compared to clopidogrel, previous standard treatment for patients with myocardial infarction. Activated platelets release pro-inflammatory and procoagulant platelet extracellular vesicles. The investigators assume that decrease in infection-related mortality in patients treated with ticagrelor may be explained by greater inhibition of the release of platelet vesicles by ticagrelor, compared to clopidogrel. This study is expected to identify an additional mechanism of action of ticagrelor, which might contribute to the observed clinical benefits in patients treated with ticagrelor.

NCT ID: NCT02929459 Completed - Gut Microbiota Clinical Trials

Effects of Riboflavin on Faecalibacterium Prausnitzii and the Gut Microbiota

Start date: November 1, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to investigate comprehensively the effect of riboflavin supplementation on the abundance of F. prausnitzii and on other members of the gut microbiota in faeces of healthy volunteers. Additionally it will be assessed whether riboflavin supplementation affects the abundance of potentially pathogenic bacteria such as adherent invasive E. coli (AIEC). Finally, the effect of riboflavin supplementation on the production of Short Chain Fatty Acids, the release of gut hormones and potential changes in glucose homeostasis and appetite perception will be assessed.

NCT ID: NCT02929394 Terminated - Clinical trials for Sarcoma, Soft Tissue

Trabectedin Maintenance Post 1st-line in STS

Start date: November 7, 2017
Phase: Phase 3
Study type: Interventional

Maintenance therapy with trabectedin versus observation after first line treatment with doxorubicin of patients with advanced or metastatic soft tissue sarcoma. This is a prospective, multicenter, randomized, open label Phase III trial investigating whether a maintenance treatment with trabectedin, as compared to the observational approach, can prolong progression-free survival in patients with advanced, inoperable and/or metastatic STS after response or stabilisation during first line treatment with doxorubicin.

NCT ID: NCT02929329 Completed - Heart Failure Clinical Trials

Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction

GALACTIC-HF
Start date: January 6, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if treatment with omecamtiv mecarbil when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in adults with chronic heart failure with reduced ejection fraction (HFrEF).

NCT ID: NCT02928497 Active, not recruiting - Stroke Clinical Trials

Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation

ASAP-TOO
Start date: February 6, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to establish the safety and effectiveness of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device, including the post-implant medication regimen, for subjects with non-valvular atrial fibrillation who are deemed not to be eligible for anti-coagulation therapy to reduce the risk of stroke.

NCT ID: NCT02928445 Terminated - Clinical trials for Dementia With Lewy Bodies

Long-Term Extension Study of Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: HEADWAY-DLB Extension

Start date: October 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This 6-month extension study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) in subjects with Dementia with Lewy bodies (DLB) who have participated in the double-blind, placebo-controlled, lead-in study RVT-101-2001.

NCT ID: NCT02928406 Completed - Clinical trials for Urinary Tract Cancer

A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract

Start date: November 30, 2016
Phase: Phase 3
Study type: Interventional

This Phase IIIb, multicenter study will assess the safety of atezolizumab as second- to fourth-line treatment for participants with locally advanced or metastatic urothelial or non-urothelial cancer of the urinary tract in addition to evaluate the efficacy of atezolizumab and potential tumor biomarkers associated with atezolizumab.