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NCT ID: NCT02005471 Completed - Clinical trials for Chronic Lymphocytic Leukemia

A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

MURANO
Start date: March 17, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this open-label, multicenter, randomized, Phase III study is to evaluate the benefit of venetoclax in combination with rituximab compared with bendamustine in combination with rituximab in participants with relapsed or refractory CLL. Participants will be randomly assigned in 1:1 ratio to receive either venetoclax + rituximab (Arm A) or bendamustine + rituximab (Arm B).

NCT ID: NCT02005354 Completed - Pain Clinical Trials

Does Trans-Cutaneous Electrical Nerve Stimulation (TENS) Alleviate The Pain Experienced During Bone Marrow Sampling?

TENS
Start date: February 2014
Phase: N/A
Study type: Interventional

The approach of this study will be to answer the question does high-frequency stimulation Trans-Cutaneous Electrical Nerve Stimulation (TENS) alleviate the pain experienced during the bone marrow sampling procedure in addition to the standard analgesia given (ie. local anaesthetic with or without inhaled nitrous oxide). Null hypothesis: TENS does not alleviate the pain experienced during the bone marrow sampling procedure in addition to the standard analgesia given

NCT ID: NCT02004873 Completed - Clinical trials for Class I or II Indication for Implantation of a Single Chamber Ventricular Pacemaker According to ACC/AHA/HRS 2001 Guidelines and Any National Guidelines

Micra Transcatheter Pacing Study

Start date: November 2013
Phase: N/A
Study type: Interventional

The purpose of this clinical study is to evaluate the safety and efficacy of the Micra Transcatheter Pacing System and to assess long term performance.

NCT ID: NCT02004704 Completed - Clinical trials for Sphingomyelin Lipidosis

A Long-Term Study of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency

Start date: December 4, 2013
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to obtain data regarding the safety of olipudase alfa in patients with acid sphingomyelinase deficiency (ASMD) who are exposed to long term treatment with olipudase alfa. The secondary objectives of this study are to obtain data regarding the efficacy of olipudase alfa and to characterize olipudase alfa pharmacodynamics (PD) and pharmacokinetics (PK) following long-term administration.

NCT ID: NCT02004691 Completed - Clinical trials for Sphingomyelin Lipidosis

Efficacy, Safety, Pharmacodynamic, and Pharmacokinetics Study of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency

ASCEND
Start date: December 18, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Primary Objective: The primary objective of this phase 2/3 study is to evaluate the efficacy of olipudase alfa (recombinant human acid sphingomyelinase) administered intravenously once every 2 weeks for 52 weeks in adult participants with acid sphingomyelinase deficiency (ASMD) by assessing changes in: 1) spleen volume as measured by abdominal magnetic resonance imaging (MRI) (and, for the United States [US] only, in association with participant perception related to spleen volume as measured by splenomegaly-related score [SRS]); and 2) infiltrative lung disease as measured by the pulmonary function test, diffusing capacity of the lung for carbon monoxide (DLCO). Secondary Objectives: - To confirm the safety of olipudase alfa administered intravenously once every 2 weeks for 52 weeks. - To characterize the effect of olipudase alfa on the participant perception related to spleen volume as measured by the SRS after 52 weeks of study drug administration. (For the US, the effect of olipudase alfa on the SRS is part of the primary objective). - To characterize the effect of olipudase alfa after 52 weeks of study drug administration on the following outcome measures assessed sequentially: - The effect of olipudase alfa on liver volume; - The effect of olipudase alfa on platelet count; - The effect of olipudase alfa on fatigue; - The effect of olipudase alfa on pain; - The effect of olipudase alfa on dyspnea.

NCT ID: NCT02004522 Completed - Clinical trials for Chronic Lymphocytic Leukemia

A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO)

Start date: November 2013
Phase: Phase 3
Study type: Interventional

A Phase 3 clinical trial to examine the efficacy of duvelisib monotherapy versus ofatumumab monotherapy in subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).

NCT ID: NCT02004431 Completed - Depression Clinical Trials

Peri-operative Psychology and Post-operative Pain Study

4P
Start date: January 2014
Phase: N/A
Study type: Observational

The experience of pain is common among hospital inpatients. Orthopaedic surgery often results in significant pain, which may last for some time. About one in eight people will experience long-term or chronic pain after surgery, which can impact on quality of life and mood. Some risk factors are known for chronic post surgical pain (CPSP) and these include patient factors, surgical factors and anaesthetic factors. We know that mood problems (anxiety and depression) increase the risk of CPSP. What is not known is how short term changes in mood are related to the experience of pain after surgery and how this impacts on CPSP. This study is designed to investigate the relationship between both short and long-term mood problems and short and long-term pain and quality of life after orthopaedic surgery. The study will provide valuable information to allow us to design a psychological intervention, which might reduce the risk of short-term post surgical pain and CPSP. This study also aims to measure a number of other variables, which may be related to CPSP including medication use, other medically unexplained symptoms and catastrophic thinking in response to pain. All patients having planned orthopaedic surgery will be asked to enter the trial. Those consenting to involvement will complete a questionnaire assessing the variables described above. They will be divided into two groups depending on whether they have significant pain on the day after their surgery. As the primary aim of the study, the rates of significant anxiety or depression will then be compared between these two groups. Secondary outcomes will be assessed by a questionnaire sent to the patients at 6 months after their surgery. Descriptive statistics will be produced for all the variables and use to model a future study, which would assess the effect of a psychological intervention on acute and chronic post surgical pain. Our hypothesis is that patients are more likely to experience acute anxiety and depression or display catastrophic thinking if they suffer significant post-surgical pain. The study is powered to reliably detect a three-fold difference in the prevalence of psychopathology between patients with and without acute pain on day 1 after elective orthopaedic surgery.

NCT ID: NCT02004301 Completed - Pain Clinical Trials

A Study to Investigate Delayed-release Tablets

Start date: January 2014
Phase: Phase 1
Study type: Interventional

This is a single-centre, open-label, non-randomised, two-arm study in 12 healthy male volunteers. This study is designed to correlate the gastrointestinal transit behaviour of delayed-release diclofenac potassium tablets with their pharmacokinetic (PK) absorption profiles. We will be looking at: 1. The behaviour of the tablets (when, where and how quickly they break up) 2. The gastric emptying time of the tablets (when they leave the stomach) 3. The gastrointestinal transit of the tablets (how long they take to travel through the gut) 4. Blood levels of the drug (diclofenac)

NCT ID: NCT02004106 Completed - Neoplasms Clinical Trials

A Study to Evaluate Safety, Pharmacokinetics, and Efficacy of RO6895882 in Participants With Advanced and/or Metastatic Solid Tumors

Start date: December 31, 2013
Phase: Phase 1
Study type: Interventional

This open-label, multi-center, dose-escalation study will evaluate the safety, pharmacokinetics, and therapeutic activity of RO6895882 in participants with Carcinoembryonic Antigen (CEA)-positive solid tumors who have progressed on the standard of care therapy. The study will be conducted in 3 parts. Part 1 will be a single ascending dose study in single participant cohort at low RO6895882 dose (less than or equal to [</=] 6 milligrams [mg]). Part 2 will be a dose-escalation study of RO6895882 monotherapy given every week (qw), every 2 weeks (q2w), and possibly every 3 weeks (q3w). Part 3 will be an expansion phase of the qw, q2w, and possibly q3w at maximum tolerated dose (MTD) (as determined in Part 2). Part 3 will only be conducted if the risk/benefit assessment, as evaluated by the Sponsor and the investigators, is in favor of the participants. Participants will be treated until disease progression, unacceptable toxicity or withdrawal from treatment for other reasons or death for a maximum duration of 24 months.

NCT ID: NCT02004093 Completed - Ovarian Cancer Clinical Trials

A Study to Evaluate the Effect of the Combination of Pertuzumab With Carboplatin-Based Standard Chemotherapy in Patients With Recurrent Ovarian Cancer

Start date: December 2005
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of pertuzumab in combination with carboplatin-based standard chemotherapy in patients with platinum-sensitive recurrent ovarian cancer. The anticipated time on study treatment is 3-12 months.