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PubMed Journals Articles About "ObsEva Starts Phase Clinical Program Nolasiban" RSS

21:18 EDT 17th August 2018 | BioPortfolio

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Showing "ObsEva Starts Phase Clinical Program Nolasiban" PubMed Articles 1–25 of 37,000+

Bayesian sample size determination for a Phase III clinical trial with diluted treatment effect.

When Phase III treatment effect is diluted from what was observed from Phase II results, we propose to determine the Bayesian sample size for a Phase III clinical trial based on the normal, uniform, and truncated normal prior distributions of the treatment effects on an interval, which starts from an acceptable treatment effect to the observed treatment effect from Phase II. After incorporating the prior information of the treatment effects, the Bayesian sample size is the number of patients of the Phase II...


Assessing the pattern of recurrence in Danish stage I lung cancer patients in relation to the follow-up program: are we failing to identify patients with cerebral recurrence?

There is paucity of evidence regarding the optimal follow-up (FU) regimen for lung cancer. Consequently, FU is organized differently across countries. The Danish FU regimen has short FU intervals with a computed tomography (CT) scan of the chest and upper abdomen every three months in the early phase (first 2 years), then every six months in the late phase of FU (3rd, 5th year). Characterizing recurrences missed by the FU program in terms of site, tumor histology, department, and phase of FU, could improve ...

Which Patients with Type 2 Diabetes Will Have Greater Compliance to Participation in the Diabetes Conversation Map™ Program? A Retrospective Cohort Study.

To investigate the characteristics of participants in the Diabetes Conversation Map™ (Map™) program who had higher vs. lower compliance to the program, to determine if program tailoring and monitoring is needed among these groups.


Enhancing Graduate Nurse Transition: Report of the Evaluation of the Clinical Honors Program.

The Bachelor of Nursing with Clinical Honors (Transition to Practice) program supports the transition of nursing graduates. It is the first initiative of its kind in Australia and is designed to integrate with existing graduate transition programs. The program is clinically focused, collaborative, and accessible online.

Adapting evidence-based clinical practice guidelines at university teaching hospitals: A model for the Eastern Mediterranean Region.

Clinical practice guidelines (CPGs) are significant tools for evidence-based health care quality improvement. The CPG program at King Saud University was launched as a quality improvement program to fulfil the international accreditation standards. This program was a collaboration between the Research Chair for Evidence-Based Healthcare and Knowledge Translation and the Quality Management Department. This study aims to develop a fast-track method for adaptation of evidence-based CPGs and describe results of...

Characteristics of Volunteer Coaches in a Clinical Process Improvement Program.

The Partners Clinical Process Improvement Leadership Program provides quality improvement training for clinicians and administrators, utilizing graduates as volunteer peer coaches for mentorship. We sought to understand the factors associated with volunteer coach participation and gain insight into how to improve and sustain this program.

A comparison between phase-III trials and a phase-IV study of nalmefene in alcohol use disorder patients. Is there a difference?

Concerns regarding the external validity of phase-III trials are common to many medical disciplines, with relevant discrepancies found between experimental and clinical samples in some diseases such as hypertension. The aim of this study was to compare the samples included in the pivotal, phase-III clinical trials of nalmefene with that of a recently conducted phase-IV trial. Baseline characteristics of the studies were compared through univariate analysis. Significant differences were found in the percenta...

Quantitative decision-making in randomized Phase II studies with a time-to-event endpoint.

One of the most critical decision points in clinical development is Go/No-Go decision-making after a proof-of-concept study. Traditional decision-making relies on a formal hypothesis testing with control of type I and type II error rates, which is limited by assessing the strength of efficacy evidence in a small isolated trial. In this article, we propose a quantitative Bayesian/frequentist decision framework for Go/No-Go criteria and sample size evaluation in Phase II randomized studies with a time-to-even...

Adsorption of molecular oxygen on the Ag(111) surface: A combined temperature-programmed desorption and scanning tunneling microscopy study.

The adsorption of O on Ag(111) between 300 and 500 K has been studied with temperature-programmed desorption (TPD) and scanning tunneling microscopy (STM). At the first stage of adsorption, the disordered local oxide phase (commonly looking in STM as an array of black spots) is formed on the surface irrespective of the substrate temperature. The maximum concentration of black spots was found to be ≈0.11 ML, which corresponds to an oxygen coverage of ≈0.66 ML. Taking into account that the nucleation of t...

Evaluation of the bag-mediated filtration system as a novel tool for poliovirus environmental surveillance: Results from a comparative field study in Pakistan.

Poliovirus (PV) environmental surveillance (ES) plays an important role in the global eradication program and is crucial for monitoring silent PV circulation especially as clinical cases decrease. This study compared ES results using the novel bag-mediated filtration system (BMFS) with the current two-phase separation method. From February to November 2016, BMFS and two-phase samples were collected concurrently from twelve sites in Pakistan (n = 117). Detection was higher in BMFS than two-phase samples for ...

Malaria burden and treatment targets in Kachin Special Region II, Myanmar from 2008 to 2016: A retrospective analysis.

Although drug-based treatment is the primary intervention for malaria control and elimination, optimal use of targeted treatments remains unclear. From 2008 to 2016, three targeted programs on treatment were undertaken in Kachin Special Region II (KR2), Myanmar. Program I (2008-2011) treated all confirmed, clinical and suspected cases; program II (2012-2013) treated confirmed and clinical cases; and program III (2014-2016) targeted confirmed cases only. This study aims to evaluate the impacts of the three p...

Digital versus traditional: are diagnostic accuracy rates similar for glass slides versus whole slide images in a non-gynaecological external quality assurance setting?

The Royal College of Pathologists of Australasia Quality Assurance Programs introduced virtual microscopy cases into its cytopathology non-gynaecological program after a short pilot phase, to address the challenges of providing a purely glass slide-based external quality assurance program to multiple participants both locally and internationally. The use of whole slide image (WSI) cases has facilitated a more robust program in relation to standardised material and statistical analysis, with access to a wide...

Practical Tips for Implementing the Diabetes Prevention Program in Clinical Practice.

The Diabetes Prevention Program (DPP) is an evidence-based lifestyle change program for prediabetes that is associated with a 58% reduction in 3-year diabetes incidence, and it has been supported by the American Medical Association and the Centers for Disease Control and Prevention. However, 9 in 10 patients are unaware they have the condition.

Symptomatic Hemorrhagic Complications in Clot Lysis: Evaluation of Accelerated Resolution of Intraventricular Hemorrhage Phase III Clinical Trial (CLEAR III): A Posthoc Root-Cause Analysis.

As intraventricular thrombolysis for intraventricular hemorrhage (IVH) has developed over the last 2 decades, hemorrhagic complications have remained a concern despite general validation of its safety in controlled trials in the Clot Lysis: Evaluation of Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR-IVH) program.

Use of e-learning in clinical clerkships: effects on acquisition of dermatological knowledge and learning processes.

To obtain a deeper understanding of how the e-learning program, Education in Dermatology (ED), affects the acquisition of dermatological knowledge and the underlying learning processes of medical students in their clinical phase.

Transition Experiences in MD-PhD Programs.

MD-PhD training takes, on average, 8 years to complete and involves two transitions, an MD-preclinical to PhD-research phase and a PhD-research to MD-clinical phase. There is a paucity of research about MD-PhD students' experiences during each transition. This study examined transition experiences reported by 48 MD-PhD students who had experienced at least one of these transitions during their training. We purposefully sampled medical schools across the United States to recruit participants. Semistructured ...

Evaluation of the Group Lifestyle Balance Program in a Military Setting: An Investment Worth Expanding.

The Diabetes Prevention Program (DPP) demonstrated that lifestyle intervention programs were effective in preventing or delaying the onset of diabetes. The Group Lifestyle Balance (GLB) program translated the DPP curriculum into a 12-wk group intervention for those at risk for diabetes. This retrospective evaluation examined clinical outcomes for patients in the Diabetes Center of Excellence GLB program located at Wilford Hall Ambulatory Surgical Center from 2009 to 2013. Objectives included determining rat...

Animal-Facilitated Therapy Program: Outcomes from Caring Canines, a Program for Patients and Staff on an Inpatient Surgical Oncology Unit.

Animal-facilitated therapy (AFT) is a complementary medicine intervention. To the authors' knowledge, no study has investigated the benefits of an AFT program in an adult surgical oncology setting.

Adherence to Radiology Recommendations in a Clinical CT Lung Screening Program.

Assess patient adherence to radiologist recommendations in a clinical CT lung cancer screening program.

Evolution and literature review of robotic general surgery resident training 2002-2018.

The University of Illinois purchased their first da Vinci System in September of 2002. Within the first calendar year, their program began orienting trainees to the da Vinci Standard System to make its inclusion in their clinical training run more smoothly. During the ensuring 16 years, their program has evolved into more frequent resident orientations, lectures, and courses. The program has grown over the course of different versions of the da Vinci System. Currently, their program houses three Xi and two...

Illness management and recovery: Clinical outcomes of a randomized clinical trial in community mental health centers.

Illness Management and Recovery (IMR) is a psychosocial intervention with a recovery-oriented approach. The program has been evaluated in different settings; however evidence for the effects of IMR is still deficient. The aim of this trial was to investigate the benefits and harms of the IMR program compared with treatment as usual in Danish patients with schizophrenia or bipolar disorder.

Perceived Benefits and Barriers of a Community-Based Diabetes Prevention and Management Program.

This study examined the perceptions of benefits of and barriers to participating in a community-based diabetes program to improve program effectiveness. The Diabetes Prevention and Management (DPM) program was a twenty-two session, 1-year program, modeled after the evidence-based National Diabetes Prevention Program and AADE7 Self-Care Behaviors framework. Community-based participatory research approach was used to culturally tailor the curriculum. Participants included overweight or obese adults with dysgl...

The new reckoning: The Combat Casualty Care Research Program responds to real and present challenges in military operational projections.

This issue of the Journal of Trauma and Acute Care Surgery features topics from the 2017 Military Health System Research Symposium and starts a second decade of partnership between the Combat Casualty Care Research Program (CCCRP) and the journal. This publication comes at a time of significant change for the CCCRP, as it responds to military planning for the future multidomain battlefield (MDB). The projected MDB portends markedly different operational scenarios than those conducted over the past 17 years....

The effect of swallowing rehabilitation on quality of life of the dysphagic patients with cortical ischemic stroke.

Swallowing and swallowing-related quality of life studies following stroke were almost always performed by including both patients with brainstem and cortical involvement. It was aimed in this study to show the presence of dysphagia in patients with only cortical ischemic stroke and to investigate the interaction between dysphagia and quality of life as well as to evaluate the effect of a rehabilitation program in the acute phase. Seventy-two patients with cortical stroke (between 0 and 30 days) and dyspha...

The exaggerated blood pressure response to exercise in the sub-acute phase after stroke is not affected by aerobic exercise.

The prevalence of an exaggerated exercise blood pressure (BP) response is unknown in patients with subacute stroke, and it is not known whether an aerobic exercise program modulates this response. The authors randomized 53 patients (27 women) with subacute stroke to 12 weeks of twice-weekly aerobic exercise (n = 29) or to usual care without scheduled physical exercise (n = 24). At baseline, 66% of the patients exhibited an exaggerated exercise BP response (peak systolic BP ≥210 mm Hg in men and ≥...


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