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NCT ID: NCT03721341 Active, not recruiting - Metastatic Tumors Clinical Trials

Stereotactic Ablative Radiotherapy for Comprehensive Treatment of 4-10 Oligometastatic Tumors

SABR-COMET 10
Start date: February 22, 2019
Phase: Phase 3
Study type: Interventional

In patients with a limited oligometastatic burden (cancer has spread but is not yet considered metastatic), emerging evidence suggests that treatment of all sites of disease with ablative therapies can improve patient outcomes, including overall- and progression-free survival. The application of Stereotactic Ablative Radiotherapy (SABR) for patients with 4-10 metastatic deposits appears promising, yet it is unclear if all patients with greater than 3 oligometastatic lesions benefit from ablative therapies in terms of improved Overall Survival (OS), Progression Free Survival (PFS), or quality of life. The purpose of this study is to assess the impact of SABR, compared to standard of care treatment, on overall survival, oncologic outcomes, and quality of life in patients with a controlled primary tumor and 4-10 metastatic lesions.

NCT ID: NCT03710603 Active, not recruiting - Multiple Myeloma Clinical Trials

Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects With Previously Untreated Multiple Myeloma

Perseus
Start date: December 14, 2018
Phase: Phase 3
Study type: Interventional

Background of the study: The combination of daratumumab with VRd is anticipated to further improve response rates in patients and may lead to improved long-term outcomes in newly diagnosed patients with multiple myeloma. Given this potential, and based upon the initial safety and efficacy observed in the ongoing Phase 2 Study MMY2004, as well as continued positive results with daratumumab in various disease settings and combination regimens, this Phase 3 study is designed to demonstrate improved outcomes for patients treated with daratumumab+VRd. The Phase 3 study will utilize the subcutaneous (SC) formulation of daratumumab instead of the IV formulation utilized in the Phase 2 study, which may limit additional toxicity to patients treated with the quadruplet regimen.

NCT ID: NCT03708003 Active, not recruiting - Leukemia Clinical Trials

Ibrutinib lead-in Followed by Venetoclax Plus Ibrutinib in Patients With RR CLL

Start date: March 11, 2019
Phase: Phase 2
Study type: Interventional

Venetoclax and ibrutinib have complementary activity in clearing the disease across anatomical compartments. By combining ibrutinib with venetoclax, cells can be mobilized from tissues into the bloodstream by ibrutinib and killed in the blood by venetoclax. Consistently, the venetoclax-ibrutinib combination can achieve undetectable minimal residual disease (MRD-neg) in a sizable proportion of patients. Gentle debulking obtained with a lead-in phase of ibrutinib monotherapy may allow starting venetoclax when the disease has been reshaped in a size that fits for low-risk of tumor lysis syndrome (TLS), a rare adverse event (AE) of venetoclax. MRD-guided treatment duration may allow patients achieving a negative status to gain drug-free intervals and less medicalization, and may avoid all the potential, and not yet completely known implications of continuous therapy on long-term safety, drug interactions, quality of life, compliance to treatment, and economic sustainability.

NCT ID: NCT03703739 Active, not recruiting - Iron-deficiency Clinical Trials

Iron Absorption From Iron Fortified Extruded Rice Co-fortified With Various Solubilizing Agents

Start date: October 2, 2018
Phase: N/A
Study type: Interventional

Food fortification is regarded as a safe and cost-effective approach to counteract and prevent iron deficiency. Rice is a staple food for millions of people living in regions where iron-deficiency anaemia is a significant public health problem. Therefore, rice may be a promising fortification vehicle. Ferric pyrophosphate (FePP) is an acceptable iron compound for rice fortification, due to its white colour and low reactivity with the rice matrix. However, iron from FePP generally has a low bioavailability. To increase the low iron bioavailability of FePP in fortified rice, ligands acting as solubilizing agents have been suggested, such as citric acid/trisodium citrate (CA/TSC), ethylenediaminetetraacetic acid (EDTA) and sodium pyrophosphate (NaPP). It is however unclear to which extent CA/TSC would enhance iron bioavailability in presence of phytic acid, a common inhibitor of iron absorption found in whole grains and legumes. Zinc oxide reduces iron bioavailability from FePP with and without CA/TSC, in contrast to Zinc sulphate. It is however unclear if this decrease would be also expected in presence of EDTA as solubilizing agent. Further, NaPP has been suggested as a solubilizing agent, enhancing the bioavailability from FePP in bouillon cubes. This study aim to test its effect in rice. Meals containing a high (bean sauce) and low (mixed vegetable) phytic acid level sauce will be used to simulated varying dietary backgrounds, allowing to answer the question which solubilizing agent is viable in enhancing iron bioavailability.

NCT ID: NCT03703726 Active, not recruiting - Iron-deficiency Clinical Trials

Iron Absorption From Fortified Extruded Rice Using Different Extruding Temperatures.

Start date: September 25, 2018
Phase: N/A
Study type: Interventional

Food fortification is regarded as a safe and cost-effective approach to counteract and prevent iron deficiency. Rice is a staple food for millions of people living in regions where iron-deficiency anaemia is a significant public health problem. Therefore, rice may be a promising fortification vehicle. Hot and cold extrusion, have been identified as the major methods for rice fortification. Extruded rice has the advantage of incorporating vitamins and minerals into the food matrix. Cold, warm and hot extrusion differ in the processing temperature and the physical structure of fortified rice kernel matrix. A recent human study in young women showed fractional iron absorption was higher in cold extruded rice compared to hot extruded Rice and this was associated with changes in the starch microstructure. These changes cannot be detected in warm extruded rice, thus, our aim is to test the iron bioavailability in difference extrusion methods; hot and warm and cold with and without the solubilizing agent CA/TSC. This will provide information on optimized rice formulations for optimal iron delivery.

NCT ID: NCT03697512 Active, not recruiting - Clinical trials for Splenic Marginal Zone Lymphoma

MALIBU Trial - Combination of Ibrutinib and Rituximab in Untreated Marginal Zone Lymphomas

MALIBU
Start date: September 27, 2019
Phase: Phase 2
Study type: Interventional

Single-arm, phase II clinical trial of patients with Extranodal Marginal Zone Lymphoma (EMZL). It is planned to recruit 130 patients. Additional patients with Splenic Marginal Zone Lymphoma (SMZL), up to 30, and Nodal Marginal Zone Lymphoma (NMZL), up to 15, will be included in the trial in order to preliminary explore the clinical activity and safety of the combination treatment proposed. The study primary endpoints will be analysed on the EMZL population. Outcome of patients with SMZL and NMZL will be analysed and reported separately

NCT ID: NCT03692065 Active, not recruiting - Clinical trials for Cancer-associated Thrombosis

API-CAT STUDY for APIxaban Cancer Associated Thrombosis

API-CAT
Start date: October 11, 2018
Phase: Phase 3
Study type: Interventional

The main objective is to determine whether a low-dose regimen of apixaban (2.5 mg bid) is non inferior to a full-dose regimen of apixaban (5 mg bid) for the prevention of recurrent venous thromboembolism (VTE) in patients with active cancer who have completed at least 6 months of anticoagulant therapy for treating a documented index event of proximal deep venous thrombosis (DVT) (symptomatic or incidental) or pulmonary embolism (symptomatic or incidental).

NCT ID: NCT03685110 Active, not recruiting - Clinical trials for Degenerative Osteoarthritis

CoreHip - Post Market Clinical Follow-Up Study

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

The study is designed as a prospective, non-interventional multicentre cohort study. The product under Investigation will be used in Routine clinical practice and according to the authorized Instructions for Use (IfU). Aim of this observational study is to collect clinical and radiological results of the CoreHip® endoprosthesis system in a Standard Patient Population and when used in Routine clinical practice.

NCT ID: NCT03684603 Active, not recruiting - Stroke Clinical Trials

Acoustic Cueing During Slow-wave Sleep as a Measure to Improve Motor Rehabilitation Outcome in Stroke Patients

Start date: November 1, 2017
Phase: N/A
Study type: Interventional

This project aims at gaining insight into the role of sleep in motor learning and the first to apply sleep related learning methods in a rehabilitative setting. The primary objective is to investigate whether there is an effect of acoustic cueing during slow wave sleep on a specific motor task. The second objective is to investigate whether this effect can also be transferred to generalized motor rehabilitation outcome. Patients with an impairment of the arm function are randomized to either receiving the intervention ("cueing group") or to the control group. The patients are all listening to a melody during motor training but only the patients of the cueing group are also exposed to the melody during subsequent slow wave sleep. Performance gain is measured using an instrumented arm orthosis which is used for functional arm therapy over the sudy period of 5 consecutive days as well as during standard clinical assessments.

NCT ID: NCT03682536 Active, not recruiting - Clinical trials for Myelodysplastic Syndromes

A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve

COMMANDS
Start date: January 2, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at least 1.5 g/dL in participants with anemia due to revised international prognostic scoring system (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require RBC transfusions and have never been exposed to erythropoiesis stimulating agent (ESA).