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PubMed Journals Articles About "A Phase 2 Study With Enzastaurin Plus Chemotherapy Or Placebo Plus Chemotherapy For Prostate Cancer Patients" RSS

21:08 EST 21st January 2019 | BioPortfolio

A Phase 2 Study With Enzastaurin Plus Chemotherapy Or Placebo Plus Chemotherapy For Prostate Cancer Patients PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest A Phase 2 Study With Enzastaurin Plus Chemotherapy Or Placebo Plus Chemotherapy For Prostate Cancer Patients articles that have been published worldwide.

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Showing "Phase Study With Enzastaurin Plus Chemotherapy Placebo Plus" PubMed Articles 1–25 of 65,000+

A phase I/II study of GLIF combination chemotherapy for taxane/platinum-refractory/resistant endometrial cancer (GOGO-EM2).

Development of new treatment strategies for endometrial cancer that has become refractory or resistant to taxane/platinum is a critical need. The present study was a phase I/II study of gemcitabine, levofolinate, irinotecan, and 5-fluorouracil (5-FU) (GLIF) combination chemotherapy to determine optimal dosages, safety, and efficacy.


Randomized Phase II Study of Consecutive-Day versus Alternate-Day Treatment with S-1 as Second-Line Chemotherapy in Advanced Pancreatic Cancer.

To evaluate the efficacy and safety of alternate-day administration of S-1 as second-line chemotherapy for unresectable pancreatic cancer in a multicenter, randomized, phase II study.

Randomized, placebo-controlled, phase III trial of fosaprepitant, ondansetron, dexamethasone (FOND) versus FOND plus olanzapine (FOND-O) for the prevention of chemotherapy-induced nausea and vomiting in patients with hematologic malignancies receiving highly emetogenic chemotherapy and hematopoietic cell transplantation regimens: the FOND-O Trial.

Evidence supports olanzapine for prophylaxis of chemotherapy-induced nausea/vomiting (CINV) for highly emetogenic chemotherapy (HEC); however, most studies focus on solid malignancies and single day regimens. A randomized, double-blinded, placebo-controlled trial was conducted to compare addition of olanzapine to triplet therapy (fosaprepitant, ondansetron, dexamethasone; FOND-O) versus triplet therapy alone (FOND) in preventing CINV in hematology patients receiving single and multi-day HEC and hematopoieti...


Updated results from the phase 3 HELIOS study of ibrutinib, bendamustine, and rituximab in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma.

We report follow-up results from the randomized, placebo-controlled, phase 3 HELIOS trial of ibrutinib+bendamustine and rituximab (BR) for previously treated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) without deletion 17p. Overall, 578 patients were randomized 1:1 to either ibrutinib (420 mg daily) or placebo, in combination with 6 cycles of BR, followed by ibrutinib or placebo alone. Median follow-up was 34.8 months (range: 0.1-45.8). Investigator-assessed median progression-free...

Fulranumab as Adjunctive Therapy for Cancer-Related Pain: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study.

This randomized, double-blind (DB), placebo-controlled, phase 2 study assessed the efficacy and safety of fulranumab as a pain therapy adjunctive to opioids in terminally-ill cancer patients. Ninety-eight patients were randomized (2:1) to receive one subcutaneous injection of fulranumab (9 mg) or placebo in the 4-week DB phase. Seventy-one (72%) patients entered the 48-week open-label extension phase and were administered 9 mg fulranumab every 4 weeks. The study failed to demonstrated efficacy at the end of...

Does chlorhexidine mouthwash reduce the rate of oral colonization by gram-negative bacteria in patients with chemotherapy? A placebo-controlled trial.

The presence of gram-negative bacteria in the oral cavity is an undesirable occurrence in patients undergoing chemotherapy. Our aim was to investigate the antibacterial effect of 0.12% chlorhexidine mouthwash in chemotherapy patients with a randomized, double-blind, placebo-controlled trial. There were no significant differences between oral colonization rates; there may be local factors that interfere with chlorhexidine activity.

Bone mineral density response rates are greater in patients treated with abaloparatide compared with those treated with placebo or teriparatide: Results from the ACTIVE phase 3 trial.

Abaloparatide is a 34-amino acid peptide that selectively binds to the RG conformation of the parathyroid hormone receptor type 1. It was developed for the treatment of women with postmenopausal osteoporosis at high risk of fracture. In ACTIVE, an 18-month phase 3 study (NCT01343004), abaloparatide increased bone mineral density (BMD), decreased the risk of vertebral and nonvertebral fractures compared with placebo, and decreased the risk of major osteoporotic fractures compared with placebo and teriparatid...

Abuse Potential of Samidorphan: A Phase I, Oxycodone-, Pentazocine-, Naltrexone-, and Placebo-Controlled Study.

Samidorphan is a μ-opioid receptor antagonist in development for the treatment of schizophrenia, in combination with olanzapine, and major depressive disorder, in combination with buprenorphine, at proposed therapeutic doses of samidorphan 10 mg and 2 mg, respectively. A double-blind, double-dummy, active- and placebo-controlled, crossover study evaluated the abuse potential of samidorphan in healthy, nondependent, recreational opioid users. Following a qualification phase, participants were randomized t...

A Phase 1 Assessment of the QT Interval in Healthy Adults Following Exposure to Rolapitant, a Cancer Supportive Care Antiemetic.

This 2-part study evaluated the QT/QTc prolongation potential and safety and pharmacokinetics of the antiemetic rolapitant, a neurokinin-1 receptor antagonist. Part 1 was a randomized, placebo-controlled single-dose-escalation study assessing the safety of a single high dose of rolapitant. Part 2 was a randomized, placebo- and positive-controlled, double-blind parallel-group study including 4 treatment arms: rolapitant at the highest safe dose established in part 1, placebo, moxifloxacin 400 mg (positive co...

9 weeks vs 1 year adjuvant trastuzumab in combination with chemotherapy: final results of the phase III randomized Short-HER study.

Chemotherapy plus 1-year trastuzumab is the standard adjuvant treatment for HER2-positive breast cancer. The efficacy of less extended trastuzumab exposure is under investigation. The Short-HER study was aimed to assess the non-inferiority of 9 weeks vs 1 year of adjuvant trastuzumab combined with chemotherapy.

Specifications of Computerized Provider Order Entry and Clinical Decision Support Systems for Cancer Patients Undergoing Chemotherapy: A Systematic Review.

Chemotherapy medication errors are catastrophic. The prescription phase in the chemotherapy process plays a key role in the creation of medication errors, and therefore the use of computerized physician order entry (CPOE) and clinical decision support system (CDS) systems is recommended to reduce chemotherapy medication errors. The purpose of this study was to carry out a systematic review on the specifications of the CPOE and CDS systems for chemotherapy prescription.

Randomized evaluation of fibrinogen versus placebo in complex cardiovascular surgery: post hoc analysis and interpretation of phase III results.

In a multicentre, randomized-controlled, phase III trial in complex cardiovascular surgery (Randomized Evaluation of Fibrinogen vs Placebo in Complex Cardiovascular Surgery: REPLACE), single-dose human fibrinogen concentrate (FCH) was associated with the transfusion of increased allogeneic blood products (ABPs) versus placebo. Post hoc analyses were performed to identify possible reasons for this result.

Increasing effort without noticing: A randomized controlled pilot study about the ergogenic placebo effect in endurance athletes and the role of supplement salience.

Previous research shows that endurance performance can be enhanced by placebo ergogenic aids. This study investigates the ergogenic placebo response, which we define as an increase in objective and physiological effort without an increase in subjective effort, in competitive cyclists. The primary objective of this study is to explore the role of supplement salience in the ergogenic placebo response, while the secondary aim is to assess whether believing to have taken an inactive placebo supplement attenuate...

Factors Affecting Clinical and Endoscopic Outcomes of Placebo Arm in Trials of Biologics and Small Molecule Drugs in Ulcerative Colitis: A Meta-Analysis.

Previous systematic cumulative analyses of the placebo arm in ulcerative colitis (UC) were limited by the wide heterogeneity in the scores and definitions of response. We aimed at estimating the placebo rates of remission, response, and mucosal healing (MH) in phase 2 and 3 randomized placebo-controlled trials of biologics and small molecule drugs that used homogeneous criteria for the assessment of outcomes.

Ramucirumab Safety in East Asian Patients: A Meta-Analysis of Six Global, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Trials.

Purpose Several ramucirumab trials have reported a higher incidence of selected adverse events (AEs) in East Asian (EA) patients with cancer versus non-EA patients. A meta-analysis was conducted across six completed phase III trials to establish the safety parameters of ramucirumab in EA compared with non-EA patients. Materials and Methods Six global, randomized, double-blind, placebo-controlled, phase III registration trials investigating ramucirumab were assessed. Relative risks (RRs) and 95% CIs were cal...

Nintedanib for the treatment of patients with refractory metastatic colorectal cancer (LUME-Colon 1): a phase III, international, randomized, placebo-controlled study.

Angiogenesis is critical to colorectal cancer (CRC) growth and metastasis. Phase I/II studies have demonstrated the efficacy of nintedanib, a triple angiokinase inhibitor, in patients with metastatic CRC. This global, randomized, phase III study investigated the efficacy and safety of nintedanib in patients with refractory CRC after failure of standard therapies.

Results of a Phase II Study to Determine the Efficacy and Safety of Genetically Engineered Allogeneic Human Chondrocytes Expressing TGF-β1.

Genetically engineered chondrocytes virally transduced with a transforming growth factor (TGF)-1 (TG-C [TissueGene-C]) expression vector have been shown to have potential benefits in the nonoperative management of knee osteoarthritis. Previous literature has reported on safe dosages of TG-C. Therefore, the purpose of this study was to evaluate the Phase II results and a 24-month efficacy of this injectable mixture compared with placebo in patients with Kellgren-Lawrence (K-L) grade III knee osteoarthritis. ...

Using Placebo Beverages in Group Alcohol Studies.

Placebo beverage conditions remain a key element in the methodological toolkit for alcohol researchers interested in evaluating pharmacological and nonpharmacological factors influencing the effects of alcohol consumption. While interest in experimentally examining alcohol in social context is on the rise, there has been little research examining the effectiveness of placebo manipulations in group settings, when just one suspicious participant could potentially jeopardize the effect of the placebo on group ...

Hormone Therapy During Peri- and Postmenopause.

The recently published 18-year-follow-up of the WHI-study might resolve the long-standing dispute about hormone therapy, possibly reconciling the opposing parties attributing life-threatening risks to either the administration or the withholding of hormone therapy. 16 608 women without hysterectomy had taken either combined hormone therapy with estrogen and progestin or placebo for an average of 5.2 years, while 10 739 women after hysterectomy (and bilateral ovarectomy in 40 %) had taken either estrog...

PF-04447943, a Phosphodiesterase 9A Inhibitor, in Stable Sickle Cell Disease Patients: A Phase Ib Randomized, Placebo-Controlled Study.

This phase Ib study randomized patients with stable sickle cell disease (SCD) aged 18-65 years to twice-daily PF-04447943 (a phosphodiesterase 9A inhibitor; 5 or 25 mg) or placebo, with/without hydroxyurea coadministration, for up to 29 days. Blood samples were collected at baseline and various posttreatment time points for assessments of PF-04447943 pharmacokinetics (PKs)/pharmacodynamics (PDs). Change from baseline in potential SCD-related biomarkers was evaluated. Of 30 patients, 15 received hydroxyur...

MRI liver fat quantification in an oncologic population: the added value of complex chemical shift-encoded MRI.

Chemotherapy prolongs the survival of patients with advanced and metastatic tumors. Since the liver plays an active role in the metabolism of chemotherapy agents, hepatic injury is a common adverse effect. The purpose of this study is to compare a novel quantitative chemical shift encoded magnetic resonance imaging (CSE-MRI) method with conventional T1-weighted In and Out of phase (T1 IOP) MR for evaluating the reproducibility of the methods in an oncologic population exposed to chemotherapy.

A Novel Strategy to Identify Placebo Responders: Prediction Index of Clinical and Biological Markers in the EMBARC Trial.

One in three clinical trial patients with major depressive disorder report symptomatic improvement with placebo. Strategies to mitigate the effect of placebo responses have focused on modifying study design with variable success. Identifying and excluding or controlling for individuals with a high likelihood of responding to placebo may improve clinical trial efficiency and avoid unnecessary medication trials.

Efficacy and safety of intravenous chemotherapy during intensive treatment phase in patients with newly diagnosed pulmonary tuberculosis.

The purpose of our study was to examine the efficacy and safety of intravenous chemotherapy during intensive treatment phase for patients with newly diagnosed pulmonary tuberculosis (pulmonary TB).

Efficacy and Safety of Abrilumab in a Randomized, Placebo-Controlled Trial for Moderate to Severe Ulcerative Colitis.

αβ integrin is a validated target in inflammatory bowel disease. This randomized, phase 2b, placebo-controlled, double-blind study evaluated the efficacy and safety of the anti-αβ antibody abrilumab in patients with moderate-to-severe ulcerative colitis (UC) despite treatment with conventional therapies.

Placebo acceptability in chronic pain patients: More dependent on application mode and resulting condition than on individual factors.

Placebo effects can be very effective in certain pain conditions, but their use is still highly controversial. Several studies show that patients would accept a placebo treatment under certain circumstances, particularly when they are informed prior to the treatment or when there are no effective treatment alternatives. This study examines the question, which factors influence the degree of acceptability of a hypothetical placebo application.


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