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NCT ID: NCT02602314 Active, not recruiting - Clinical trials for Chronyc Myeloid Leukemia

Sustained Treatment-free Remission in BCR-ABL+ Chronic Myeloid Leukemia

SUSTRENIM
Start date: November 11, 2016
Phase: Phase 4
Study type: Interventional

The study will investigate in newly diagnosed CP-CML patients the efficacy of NIL frontline therapy vs IM followed by switch to NIL in the case of absence of optimal response as defined by the ELN criteria.

NCT ID: NCT02600234 Active, not recruiting - Heart Failure Clinical Trials

REDUCE LAP-HF RANDOMIZED TRIAL I

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

A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure.

NCT ID: NCT02598661 Active, not recruiting - Clinical trials for Myelodysplastic Syndromes

Study to Evaluate Imetelstat (GRN163L) in Subjects With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

Start date: November 24, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of imetelstat in transfusion-dependent participants with low or intermediate-1 risk myelodysplastic syndrome (MDS) that is relapsed/refractory to erythropoiesis-stimulating agent (ESA) treatment in Part 1 of the study and to compare the efficacy, in terms of red blood cell (RBC) transfusion independence (TI), of imetelstat to placebo in transfusion-dependent participants with low or intermediate-1 risk MDS that is relapsed/refractory to ESA treatment in Part 2 of the study. An Extension Phase has been included to allow continued treatment for those subjects who are benefitting from imetelstat and to continue to evaluate the long-term safety, overall survival (OS), and disease progression, including progression to acute myeloid leukemia (AML) in transfusion-dependent participants with low or immediate-1 risk MDS that is relapsed/refractory to ESA treatment.

NCT ID: NCT02587637 Active, not recruiting - Clinical trials for Discogenic Low Back Pain

Study to Evaluate the Effectiveness of DRG Stimulation for Discogenic Low Back Pain

Start date: October 2015
Phase: N/A
Study type: Observational

The purpose of this prospective post market observational pilot study is to evaluate the effect of DRG stimulation in the management of chronic discogenic pain in subjects who are refractory to other available treatments. Selected subjects will not be suitable candidates for lumbar spinal surgery and will meet the standard selection process for DRG stimulation as routinely utilised in the study centre. Results from this pilot study will inform current clinical practice and future comparative studies in this specific population.

NCT ID: NCT02578446 Active, not recruiting - Arthroplasty Clinical Trials

Uncemented Tritanium Compared With Cemented Metal-backed Tibia Components in Total Knee Replacement

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

The optimal method of total knee replacement component fixation to the bone remains a challenge. The use of bone cement is considered the gold standard and is the preferred technique for most surgeons. However, uncemented fixation methods have been developed in an attempt to tackle problems that can be seen when cement is used. The cement-bone interlock can deform and degrade over the years and can lead to aseptic loosening, especially in young and active patients. A loosened prosthesis results in an impaired functioning and painful knee in daily life for which a revision of the prosthesis may be necessary. To prevent aseptic loosening and subsequent revision surgery, new methods of uncemented fixation have been developed. One of these methods is to use a highly porous metal called Tritanium®. It can improve the biologic fixation by resembling the characteristics of trabecular bone. It is expected that this surface aids bone ingrowth and to have similar or even better results concerning early fixation properties and long-term durability compared with cemented fixation. Excellent results using this highly porous Tritanium have been seen in total hip surgery already. This single-blinded, randomized clinical trial will assess clinical and radiological outcomes including Roentgen Stereophotogrammetry (RSA) measurements of a newly approved uncemented Triathlon Tritanium CR total knee prosthesis compared with a standard cemented Triathlon metal-backed CR total knee prosthesis (both by Stryker Orthopaedics). Two arms of each 35 patients will be included. The primary outcome measure will be prosthetic migration after two years of the uncemented Triathlon Tritanium CR Total Knee and the cemented Triathlon CR Total Knee by means of RSA. It is hypothesized that the new uncemented Tritanium prosthesis will perform at least equally good in terms of migration and clinical parameters compared with the standard cemented Triathlon. The secondary outcome measure will be long-term (10-year) survival based on the two-year migration patterns combined with clinical factors and radiographic aspects. In order to identify other clinical parameters besides the fixation of the prosthesis components, clinical scores and radiographic aspects will be correlated with the RSA outcome. The 10-year results will be used to verify the predicted long-term survival results.

NCT ID: NCT02576496 Active, not recruiting - Multiple Myeloma Clinical Trials

Study of Tinostamustine, First-in-Class Alkylating HDACi Fusion Molecule, in Relapsed/Refractory Hematologic Malignancies

Start date: March 2016
Phase: Phase 1
Study type: Interventional

This study evaluates the efficacy, safety and pharmacokinetics of tinostamustine (EDO-S101) in patients with relapsed/refractory hematologic malignancies. All patients will receive tinostamustine.

NCT ID: NCT02572934 Active, not recruiting - Testicular Cancer Clinical Trials

Health Status and Burden of Late Effects in Very Long-term Testicular Cancer Survivors (STANDBY-study)

STANDBY
Start date: August 2015
Phase:
Study type: Observational

Depending on disease stage, testicular cancer (TC) treatment consists of an orchidectomy, alone or followed by radiotherapy (RT) or platinum-based chemotherapy (CT). TC survival rates are above 90% nowadays, which results in growing TC survivor population. Because of the long life expectancy of these survivors, prevention or early detection of late treatment effects has become increasingly relevant. Yet known late effects are nephrotoxicity, cardiovascular disease (CVD), secondary malignant neoplasms (SMN), neurotoxicity, pulmonary toxicity, Raynaud's phenomenon, hypogonadism, fatigue and psychosocial problems. Nephrotoxicity is an important late effect, but data is lacking in very long-term survivors since performed studies have a follow-up duration of 5-14 years. Decreased renal function is a known risk factor for CVD development and also an association between renal function and neurtoxicity via circulating platinum levels has been shown. It is hypothesized that treatment induced nephrotoxicity is prevalent in TC survivors and might be a mediator for development of late effects. The secondary aim is to assess prevalence of late effects in very long-term TC survivors: until now, most data have been collected through questionnaires in large epidemiological studies in TC survivors till approximately 10 years after treatment. The prevalence of late effects may increase over time: 10 years after treatment late effects may not be present yet, whilst late effects can emerge just after 20 years. Consequently, health status and possible late effects, resulting in morbidity, are underestimated in patients who are 20-30 years after treatment. By investigating health status of these very long-term survivors a more profound insight in the prevalence and aetiology of these late effects and the development over time can be assessed. Current treatment is very similar to TC treatment 20-30 years ago and therefore knowledge on late effects is relevant for currently treated patients. Furthermore, as a result of this study, we will better understand which factors and issues should be watched closely during follow-up, which TC survivors are at increased risk of developing late treatment effects and how to detect early damage before overt morbidity occurs.

NCT ID: NCT02568267 Active, not recruiting - Breast Cancer Clinical Trials

Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)

STARTRK-2
Start date: November 19, 2015
Phase: Phase 2
Study type: Interventional

This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.

NCT ID: NCT02553096 Active, not recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Exacerbation Self-management in COPD: The ACCESS Study

ACCESS
Start date: June 2015
Phase: N/A
Study type: Interventional

Aim is to test the effect of ACCESS ("Adaptive Computerized COPD Exacerbation Self-management Support"), a software application designed to support patients with COPD in self-management of exacerbations.

NCT ID: NCT02542618 Active, not recruiting - Depression Clinical Trials

The Efficacy of Inquiry Based Stress Reduction (IBSR) for Depression, a Clinical Trial

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

Background: Major depression is a common mental disorder with serious consequences. The societal costs of depression are high. Despite the existence of empirically-supported psychological therapies, many patients do not benefit from these treatments and relapse and recurrence percentages are high. Improvement of existing treatments or development of new and better treatments is badly needed. Inquiry Based Stress Reduction (IBSR) is a promising verbal therapy focusing on the inquiry of thoughts and could be a next step in improving psychotherapy for depression. Objective: The objective of the current study is to assess the effectiveness of IBSR. Research to date has shown that IBSR is effective in reducing symptoms of anxiety and depression. The investigators want to know if IBSR is more effective in reducing symptoms of depression than the best psychotherapeutic treatment for depression at this moment, cognitive behavioural therapy (CBT). The investigators' secondary objective is to know more about the underlying mechanisms of change of these therapies. Study design: A randomized controlled intervention study. Study population: 88 patients with a mild to moderate depression as their principal diagnosis. Intervention: IBSR or CBT