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Σάββατο 26 Ιανουαρίου 2019

New Clinical Trials

2018 Peer Reviewers
Clinical Trials, Volume 16, Issue 1, Page 106-107, February 2019.
SAGE Publications: Clinical Trials: Table of Contents
Tue Jan 22, 2019 05:52
Corrigendum
Clinical Trials, Ahead of Print.
SAGE Publications: Clinical Trials: Table of Contents
Thu Jan 17, 2019 03:57
Assessing the impact of efficacy stopping rules on the error rates under the multi-arm multi-stage framework
Clinical Trials, Ahead of Print.
SAGE Publications: Clinical Trials: Table of Contents
Wed Jan 16, 2019 12:07
Editorial: We may need large trials to find treatments for neurodegenerative diseases
Clinical Trials, Ahead of Print.
SAGE Publications: Clinical Trials: Table of Contents
Thu Jan 10, 2019 03:06
Conducting clinical trials—costs, impacts, and the value of clinical trials networks: A scoping review
Clinical Trials, Ahead of Print.
SAGE Publications: Clinical Trials: Table of Contents
Thu Jan 10, 2019 03:06
Making the case for completion bonuses in clinical trials
Clinical Trials, Ahead of Print.
SAGE Publications: Clinical Trials: Table of Contents
Thu Dec 20, 2018 11:46
Response to Chappell
Clinical Trials, Ahead of Print.
SAGE Publications: Clinical Trials: Table of Contents
Wed Dec 19, 2018 11:32
Variance prior specification for a basket trial design using Bayesian hierarchical modeling
Clinical Trials, Ahead of Print.
SAGE Publications: Clinical Trials: Table of Contents
Fri Dec 07, 2018 04:24
Commentary on Hay et al.: Can clinical trials data collection be improved by administrative data elements?
Clinical Trials, Volume 16, Issue 1, Page 18-19, February 2019.
SAGE Publications: Clinical Trials: Table of Contents
Fri Nov 23, 2018 08:29
Pilot study of the ability to probabilistically link clinical trial patients to administrative data and determine long-term outcomes
Clinical Trials, Volume 16, Issue 1, Page 14-17, February 2019.
SAGE Publications: Clinical Trials: Table of Contents
Fri Nov 23, 2018 08:26
Routinely collected data for trialists: The need for continued conversations and solution sharing
Clinical Trials, Ahead of Print.
SAGE Publications: Clinical Trials: Table of Contents
Sat Nov 17, 2018 08:12
Automated safety event monitoring using electronic medical records in a clinical trial setting: Validation study using the VA NEPHRON-D trial
Clinical Trials, Volume 16, Issue 1, Page 81-89, February 2019.
SAGE Publications: Clinical Trials: Table of Contents
Sat Nov 17, 2018 08:09
FDA-Catalyst—Using FDA's Sentinel Initiative for large-scale pragmatic randomized trials: Approach and lessons learned during the planning phase of the first trial
Clinical Trials, Volume 16, Issue 1, Page 90-97, February 2019.
SAGE Publications: Clinical Trials: Table of Contents
Sat Nov 17, 2018 08:08
Beware of on-treatment safety analyses
Clinical Trials, Volume 16, Issue 1, Page 63-70, February 2019.
SAGE Publications: Clinical Trials: Table of Contents
Sat Nov 17, 2018 08:01
Conditional estimation and inference to address observed covariate imbalance in randomized clinical trials
Clinical Trials, Ahead of Print.
SAGE Publications: Clinical Trials: Table of Contents
Fri Nov 16, 2018 12:52
Strategic inclusion of regions in multiregional clinical trials
Clinical Trials, Volume 16, Issue 1, Page 98-105, February 2019.
SAGE Publications: Clinical Trials: Table of Contents
Fri Nov 16, 2018 12:51
The development of an end-to-end service solution to support lupus patients and improve their experience in clinical trials
Clinical Trials, Volume 16, Issue 1, Page 71-80, February 2019.
SAGE Publications: Clinical Trials: Table of Contents
Thu Nov 15, 2018 07:18
Developing a risk-based composite neurologic outcome for a trial of hydroxyurea in young children with sickle cell disease
Clinical Trials, Volume 16, Issue 1, Page 20-31, February 2019.
SAGE Publications: Clinical Trials: Table of Contents
Wed Nov 14, 2018 14:27
Commentary on Diamond et al.: The efficiency of single institutional review board review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network–initiated clinical trials
Clinical Trials, Volume 16, Issue 1, Page 11-13, February 2019.
SAGE Publications: Clinical Trials: Table of Contents
Fri Oct 26, 2018 09:23
The efficiency of single institutional review board review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network–initiated clinical trials
Clinical Trials, Volume 16, Issue 1, Page 3-10, February 2019.
SAGE Publications: Clinical Trials: Table of Contents
Wed Oct 24, 2018 05:49
Generalizing the per-protocol treatment effect: The case of ACTG A5095
Clinical Trials, Volume 16, Issue 1, Page 52-62, February 2019.
SAGE Publications: Clinical Trials: Table of Contents
Wed Oct 17, 2018 11:36
Comment on Vickers et al.
Clinical Trials, Ahead of Print.
SAGE Publications: Clinical Trials: Table of Contents
Sat Oct 13, 2018 15:13
Shift models for dose-finding in partially ordered groups
Clinical Trials, Volume 16, Issue 1, Page 32-40, February 2019.
SAGE Publications: Clinical Trials: Table of Contents
Fri Oct 12, 2018 08:26
A readily available improvement over method of moments for intra-cluster correlation estimation in the context of cluster randomized trials and fitting a GEE–type marginal model for binary outcomes
Clinical Trials, Volume 16, Issue 1, Page 41-51, February 2019.
SAGE Publications: Clinical Trials: Table of Contents
Mon Oct 08, 2018 04:11
Flu (Influenza) - Houston TX
Click image to enlargeCenters for Disease Control and Prevention (CDC) reports:·         Flu is a contagious respiratory illness caused by influenza viruses that infect the nose, throat, and sometimes the lungs·         Each year, on average, 5 % to 20 % of the U.S. population gets the flu·         You may be able to pass on flu to someone else before you know you are sick, as well as while you are sickA clinical trial testing the effectiveness of an investigational medication for the flu is now...
ClinicalConnection.com New Clinical Trials
Fri Jan 25, 2019 00:00
Flu (Influenza) - Meridian ID
Click image to enlargeCenters for Disease Control and Prevention (CDC) reports:·         Flu is a contagious respiratory illness caused by influenza viruses that infect the nose, throat, and sometimes the lungs·         Each year, on average, 5 % to 20 % of the U.S. population gets the flu·         You may be able to pass on flu to someone else before you know you are sick, as well as while you are sickA clinical trial testing the effectiveness of an investigational medication for the flu is now...
ClinicalConnection.com New Clinical Trials
Fri Jan 25, 2019 00:00
Chronic Spontaneous Urticaria - Clearwater FL
Click image to enlargeLocal dermatologists are conducting a clinical research study to test the effectiveness and safety of an investigational injected medication for Chronic Spontaneous Urticaria.
ClinicalConnection.com New Clinical Trials
Fri Jan 25, 2019 00:00
Asthma - Raleigh NC
Calling all young people with ASTHMA!Everyone's asthma is different, so new treatments are always needed. Doctors need people like you to join a new research study, to test a new investigational asthma treatment. Can you help us?  The RESPO Study for children with asthma *  Is your child aged 5-17?* Have they had symptoms consistent with an asthma diagnosis for at least 6 months?* Are they accustomed to using an inhaler? 
ClinicalConnection.com New Clinical Trials
Thu Jan 24, 2019 00:00
Primary Mitochondrial Myopathy - Atlanta GA
Click image to enlargeLocal doctors are seeking participants for a clinical research study to test the effectiveness and safety of an investigational product delivered through a pen injector to treat Primary Mitochondrial Myopathy. If you or a loved one has been diagnosed with PMM, you may qualify to participate.
ClinicalConnection.com New Clinical Trials
Thu Jan 24, 2019 00:00
Eczema - Norfolk VA
Click image to enlargeLocal doctors are recruiting volunteers for a clinical trial to evaluate the effectiveness of an investigational oral medication for moderate to severe atopic dermatitis (eczema). Take control of your health options and consider participating! 
ClinicalConnection.com New Clinical Trials
Wed Jan 23, 2019 00:00
Osteoarthritis of the Knee - Miami FL
Clinical Research Study for Osteoarthritis of the Knee Are you or a loved one living with Osteoarthritis of the Knee, and seeking care options? You may be eligible to participate in a clinical research study, evaluating the safety and effectiveness of a new investigational medication, and receive study related care at no cost! See If You Or A Loved One Qualify!Participation Requirements You or a Loved One May Qualify If You Are between 40-80 years old Have been diagnosed with Osteoarthritis...
ClinicalConnection.com New Clinical Trials
Wed Jan 23, 2019 00:00
Depression - Jamaica NY
Click image to enlarge
ClinicalConnection.com New Clinical Trials
Tue Jan 22, 2019 00:00
Treatment Resistant Depression - Middleburg Heights OH
To evaluate the efficacy, safety, and tolerability of cariprazine 1.5 mg/day and 3 mg/daycompared with placebo as an adjunctive to antidepressant therapy (ADT) in patients with major depressivedisorder (MDD) who have had an inadequate response to antidepressants alone
ClinicalConnection.com New Clinical Trials
Tue Jan 22, 2019 00:00
Depression - Cherry Hill NJ
Depression...It interferes with the ability to work, sleep, eat and enjoy life.  If you are experiencing symptoms of depression, a clinical research study may be your next step.
ClinicalConnection.com New Clinical Trials
Mon Jan 21, 2019 00:00
Flu (Influenza) - West Palm Beach CA
Click image to enlargeCenters for Disease Control and Prevention (CDC) reports:·         Flu is a contagious respiratory illness caused by influenza viruses that infect the nose, throat, and sometimes the lungs·         Each year, on average, 5 % to 20 % of the U.S. population gets the flu·         You may be able to pass on flu to someone else before you know you are sick, as well as while you are sickA clinical trial testing the effectiveness of an investigational medication for the flu is now...
ClinicalConnection.com New Clinical Trials
Mon Jan 21, 2019 00:00
Anxiety - Cherry Hill NJ
Are you often worried, tense stressed, nervous, fearful or overly concerned? Always worrying about the what-ifs? If you are an adult experiencing symptoms of ANXIETY, you may be interested in participating in a clinical research study.
ClinicalConnection.com New Clinical Trials
Mon Jan 21, 2019 00:00
At Risk for Developing Symptoms of Alzheimer's Disease - Sherman Oaks CA
California Neuroscience Research is conducting a research study of an investigational medication vs. placebo (an inactive substance) in participants who are between 60 and 75 and at increased risk for developing symptoms of Alzheimer's Disease. Participation is voluntary.Participant has one office visit (+ phone follow-ups) for genetic testing. For those that are at increased risk of developing Alzheimer's Disease and meet other inclusion and exclusion criteria, there can be up to 8 years of treatment...
ClinicalConnection.com New Clinical Trials
Mon Jan 21, 2019 00:00
Type 1 Diabetes - Chattanooga TN
Living with Type 1 Diabetes?Consider the Gazelle StudyIf you are an adult between ages 18 and 65 living with type 1 diabetes, you may be eligible to take part in the GAZELLE clinical research trial. This trial will look at an investigational fast-acting insulin to see if it works as effectively as an existing fast-acting insulin already being used to treat diabetes.
ClinicalConnection.com New Clinical Trials
Mon Jan 21, 2019 00:00
Pediatric Major Depression - Lauderdale Lakes FL
 Research study needs children and adolescents struggling with Major Depressive DisorderIf you're struggling with Major Depressive Disorder (MDD), you may qualify for the Allergan clinical research study enrolling now. Local doctors are looking for children and adolescents male and female ages 7-17 who struggle with Major Depressive Disorder.
ClinicalConnection.com New Clinical Trials
Sun Jan 20, 2019 00:00
Crohn's Disease - Southfield MI
Do you or a loved one suffer from Crohn's Disease?What is Crohn's Disease? Crohn's disease is a type of inflammatory bowel disease or IBD that may affect any part of the gastrointestinal tract from mouth to the end of the digestive tract. Signs and symptoms often include abdominal pain, diarrhea (which may be bloody if inflammation is severe), fever, and weight loss. Other complications may occur outside the gastrointestinal tract and include anemia, skin rashes, arthritis, inflammation of the...
ClinicalConnection.com New Clinical Trials
Thu Jan 17, 2019 00:00
Cancer, Obesity/Overweight and Insomnia (COIN) Study - Baltimore MD
Click image to enlargeFLYERVolunteers are needed for a research study assessing the effectiveness of a sleep intervention prior to a web- and phone-based weight loss program. The study involves 6 in-person visits and approximately 18 phone/videosessions over an 8-month period.
ClinicalConnection.com New Clinical Trials
Thu Jan 17, 2019 00:00
Flu (Influenza) - Carrollton TX
Click image to enlargeCenters for Disease Control and Prevention (CDC) reports:·         Flu is a contagious respiratory illness caused by influenza viruses that infect the nose, throat, and sometimes the lungs·         Each year, on average, 5 % to 20 % of the U.S. population gets the flu·         You may be able to pass on flu to someone else before you know you are sick, as well as while you are sickA clinical trial testing the effectiveness of an investigational medication for the flu is now...
ClinicalConnection.com New Clinical Trials
Wed Jan 16, 2019 00:00
Flu (Influenza) - Plano TX
Click image to enlargeCenters for Disease Control and Prevention (CDC) reports:·         Flu is a contagious respiratory illness caused by influenza viruses that infect the nose, throat, and sometimes the lungs·         Each year, on average, 5 % to 20 % of the U.S. population gets the flu·         You may be able to pass on flu to someone else before you know you are sick, as well as while you are sickA clinical trial testing the effectiveness of an investigational medication for the flu is now...
ClinicalConnection.com New Clinical Trials
Wed Jan 16, 2019 00:00
Moderate to Severe Facial Acne - Raleigh NC
Facial Acne StudyDo you have facial acne?You may be a candidate for our clinical research study!We are currently enrolling qualified participants in a clinical research study for an investigational topical gel.To see if you or someone you know may qualify, contact us today!
ClinicalConnection.com New Clinical Trials
Wed Jan 16, 2019 00:00
Flu (Influenza) - Austin TX
Click image to enlargeCenters for Disease Control and Prevention (CDC) reports:·         Flu is a contagious respiratory illness caused by influenza viruses that infect the nose, throat, and sometimes the lungs·         Each year, on average, 5 % to 20 % of the U.S. population gets the flu·         You may be able to pass on flu to someone else before you know you are sick, as well as while you are sickA clinical trial testing the effectiveness of an investigational medication for the flu is now...
ClinicalConnection.com New Clinical Trials
Wed Jan 16, 2019 00:00
Episodic Migraine Headaches - San Diego CA
Unhappy with the Pain and Inconvenience of Episodic Migraine Headaches?Consider Joining a Study of a Proposed New Type of Medicine.We're enrolling participants in a study of the safety and tolerability of an investigational medication for people with episodic migraine headaches.Qualified participants must:Be age 18-80Have a 1+ year history of migraines starting before age 50Have 4-14 migraines or probable migraines a month, on average, in the three months prior to joining the study 
ClinicalConnection.com New Clinical Trials
Wed Jan 16, 2019 00:00
Type 1 Diabetes - Escondido CA
Click image to enlargeLocal doctors are conducting a clinical trial to test the effectiveness of an investigational liver-selective glucokinase activator for management of Type 1 Diabetes. 
ClinicalConnection.com New Clinical Trials
Wed Jan 16, 2019 00:00
Healthy Volunteers - Flu Test Study - Fayetteville NC
Are you interested in participating in a research study of an investigational test to detect the flu?You or your child may qualify if you are experiencing symptoms of the flu.
ClinicalConnection.com New Clinical Trials
Tue Jan 15, 2019 00:00
Healthy Volunteers - Flu Test Study - San Diego CA
Flu Test Clinical Trial Participants WantedAre you interested in participating in a research study of an investigational test to detect the flu?You or your child may qualify if you are experiencing symptoms of the flu.
ClinicalConnection.com New Clinical Trials
Tue Jan 15, 2019 00:00
Depression - Oceanside CA
Is depression affecting your quality of life? Excell Research is seeking volunteers living with depression to participate in a local research study. You may qualify if you: Are between the ages of 18-75 years old Are currently taking an anti-depressant for at least 4 weeks with little to no improvement in symptoms Have tried an antidepressant (for at least 4 weeks) in the last 18 months with little to no improvement in symptoms Have been experiencing a depressive episode for 8 weeks or longer...
ClinicalConnection.com New Clinical Trials
Tue Jan 15, 2019 00:00
Healthy Volunteers - Flu Test Study - Chattanooga TN
Are you interested in participating in a research study of an investigational test to detect the flu?You or your child may qualify if you are experiencing symptoms of the flu.
ClinicalConnection.com New Clinical Trials
Tue Jan 15, 2019 00:00
Healthy Volunteers - Flu Test - Raleigh NC
Flu Test Clinical Trial Participants WantedYou or your child may qualify if you are experiencing symptoms of the flu.Flu Test Clinical Times:Thursday, Jan. 17 at 9:00 AM, 11:00 AM, 1:00 PMWeekly afterward:Monday, Wednesday, Friday at 9:00 AM, 11:00 AM, 1:00 PM
ClinicalConnection.com New Clinical Trials
Tue Jan 15, 2019 00:00
Migraine - Prairie Village KS
If you suffer with migraines and have between 4-14 migraines a month 
ClinicalConnection.com New Clinical Trials

Παρασκευή 25 Ιανουαρίου 2019

Cosmetics, Vol. 6, Pages 7: Bioactive Metabolites of the Stem Bark of Strychnosaff. darienensisand Evaluation of Their Antioxidant and UV Protection Activity in Human Skin Cell Cultures

Cosmetics, Vol. 6, Pages 7: Bioactive Metabolites of the Stem Bark of Strychnosaff. darienensisand Evaluation of Their Antioxidant and UV Protection Activity in Human Skin Cell Cultures

Cosmetics doi: 10.3390/cosmetics6010007

Authors: Aikaterini Travasarou Maria T. Angelopoulou Konstantina Vougogiannopoulou Adamantia Papadopoulou Nektarios Aligiannis Charles L. Cantrell Dimitris Kletsas Nikolas Fokialakis Harris Pratsinis

The genus Strychnos (Loganiaceae) is well-known as a rich source of various bioactive metabolites. In continuation of our phytochemical studies on plants from Amazonia, we examined Strychnosaff. darienensis, collected in Peru. This species has been traditionally used in South America and is still presently used as a drug by the Yanesha tribe in Peru. Phytochemical investigation of this plant led to the isolation and structure elucidation by ΝuclearΜagnetic Resonance and High Resolution Mass Spectroscopy of 14 compounds that belong to the categories of phenolic acids [p-hydroxybenzoic acid (1) and vanillic acid (2)], flavonoids [luteolin, (3),3-O-methyl quercetin (4), strychnobiflavone (5), minaxin (6) and 3’,4’,7-trihydroxy-flavone (7)], lignans [syringaresinol-β-D-glucoside (8), balanophonin (9) and ficusal (10)] and alkaloids [venoterpine (11), 11-methoxyhenningsamine (12), diaboline (13) and 11-methoxy diaboline (14)]. The isolated flavonoids—a class known for its anti-aging activities—were further evaluated for their biological activities on normal human skin fibroblasts. Among them, only (6), and to a lesser extent (7), exhibited cytotoxicity at 100 µg/ml. All five flavonoids suppressed intracellularreactive oxygen species (ROS) levels, either basal or following stimulation with hydrogen peroxide or both. Moreover, luteolin and strychnobiflavone protected skin fibroblasts against ultraviolet (UV)-irradiation-induced cell death. The isolated flavonoids could prove useful bioactive ingredients in the cosmetic industry.



http://bit.ly/2ScodWU

Influence of Spirulina platensis and ascorbic acid on amikacin-induced nephrotoxicity in rabbits

Abstract

The current study was performed to investigate the nephroprotective efficacy of Spirulina platensis (SP) and the possible benefits of combining SP and ascorbic acid (AA) in protecting against amikacin (AMK)-induced nephrotoxicity in rabbits. Forty-two male New Zealand rabbits were allocated to seven equal groups, receiving (I) normal saline as negative controls, (II) oral SP (500 mg/kg body weight), (III) oral AA (20 mg/kg bw), (IV) intramuscular AMK injection (100 mg/kg bw), (V) AMK plus SP, (VI) AMK plus AA, or (VII) AMK plus SP and AA at the aforementioned doses. The treatments were given once/day for 7 days. Data analysis showed that in comparison to the control group, AMK-intoxicated rabbits showed significant increases (p ≤ 0.05) in serum concentrations of creatinine, uric acid, and urea, as well as renal tissue concentrations of tumor necrosis factor-α [TNF-α], malondialdehyde [MDA], and nitric oxide [NO]. Moreover, significant (p ≤ 0.05) reductions in renal glutathione concentration, antioxidant enzymatic activities (catalase, glutathione peroxidase, and superoxide dismutase), and total antioxidant capacity were noted following AMK intoxication. Treatment by SP ameliorated most of the aforementioned AMK-induced alterations. Although treatment with AA significantly reduced the renal tissue MDA, NO, and TNF-α concentrations, it was not associated with significant ameliorations of AMK-induced changes in the serum concentrations of renal function markers or renal tissue antioxidant parameters. The nephroprotective effects of SP-AA combination were more potent than SP alone in several parameters. In conclusion, SP alone or in combination with AA minimized the nephrotoxic effects of AMK through their antioxidant and anti-inflammatory activities.



http://bit.ly/2Scktok

Randomized Trial of a Tailored Cognitive‐Behavioral Therapy Mobile Application for Anxiety in Patients with Incurable Cancer

AbstractBackground.The aim of this study was to test the efficacy of a tailored cognitive‐behavioral therapy (CBT) mobile application (app) to treat anxiety in patients with incurable cancer.Materials and Methods.Patients with incurable cancers (n = 145) who reported elevated anxiety symptoms at two cancer centers were randomized to receive either the CBT mobile app for anxiety or a mobile health education program (control) delivered via tablet computers, which patients self‐administered over 12 weeks. To assess anxiety, depression symptoms, and quality of life (QOL), we used the Hamilton Anxiety Rating Scale (HAM‐A, primary outcome), Clinical Global Impression Scale, Hospital Anxiety and Depression Scale (HADS), Patient Health Questionnaire‐9, and Functional Assessment of Cancer Therapy‐General at baseline and 12 weeks. Analysis of covariance models were calculated to assess intervention effects on patient outcomes.Results.Patients (73.8% female; 91.0% white; mean age = 56.45 years, SD = 11.30) in both study groups reported improvements in anxiety, depression symptoms, and QOL from baseline to postassessment, with no significant differences in any outcome measure between groups. Secondary analyses showed that, among the subgroup of patients with severe baseline anxiety, those randomized to the CBT app had greater improvements on the HAM‐A (Mean Difference = 7.44, standard error [SE] = 3.35, p = .037) and HADS‐Anxiety Subscale (Mean Difference = 4.44, SE = 1.60, p = .010) compared with the control group.Conclusion.Both the tailored CBT app for anxiety and the health education program were associated with improvements in anxiety, mood, and QOL, but these outcomes did not differ between study groups. The CBT app was more beneficial than health education for patients with severe baseline anxiety.Implications for Practice.A cognitive‐behavioral therapy mobile application tailored to treat anxiety in patients with advanced cancer helps improve access to evidence‐based supportive care in a convenient, private, and timely manner.

http://bit.ly/2UfRQUF

Hybrid Capture‐Based Genomic Profiling Identifies BRAF V600 and Non‐V600 Alterations in Melanoma Samples Negative by Prior Testing

AbstractBackground.BRAF and MEK inhibitors are approved for BRAF V600‐mutated advanced melanoma, with response rates of up to 70%. Responses to targeted therapies have also been observed for diverse non‐V600 BRAF alterations. Thus, sensitive, accurate, and broad detection of BRAF alterations is critical to match patients with available targeted therapies.Materials and Methods.Pathology reports were reviewed for 385 consecutive melanoma cases with BRAF mutations or rearrangements identified using a hybrid capture‐based next‐generation sequencing comprehensive genomic profiling (CGP) assay during the course of clinical care.Results.Records of prior BRAF molecular testing were available for 79 (21%) cases. Of cases with BRAF V600 mutations, 11/57 (19%) with available data were negative by prior BRAF testing. Prior negative BRAF results were also identified in 16/20 (80%) cases with non‐V600 mutations, 2 of which harbored multiple BRAF alterations, and in 2/2 (100%) cases with activating BRAF fusions. Clinical outcomes for a subset of patients are presented.Conclusion.CGP identifies diverse activating BRAF alterations in a significant fraction of cases with prior negative testing. Given the proven clinical benefit of BRAF/MEK inhibitors in BRAF‐mutated melanoma, CGP should be considered for patients with metastatic melanoma, particularly if other testing is negative.Implications for Practice.Published guidelines for melanoma treatment recommend BRAF mutational analysis, but little guidance is provided as to selection criteria for testing methodologies, or as to clinical implications for non‐V600 alterations. This study found that hybrid capture‐based next‐generation sequencing can detect BRAF alterations in samples from a significant fraction of patients with advanced melanoma with prior negative BRAF results. This study highlights the need for oncologists and pathologists to be critically aware of coverage and sensitivity limitations of various assays, particularly regarding non‐V600E alterations, of which many are potentially targetable.

http://bit.ly/2DAKDco

Suspected Hereditary Cancer Syndromes in Young Patients: Heterogeneous Clinical and Genetic Presentation of Colorectal Cancers

AbstractColorectal cancer (CRC) is rare in young patients without a confirmed family history of cancer. Reports of an increased prevalence of POLD1/POLE mutations in young patients with colorectal cancer have raised awareness and support routine genetic testing for patients with early‐onset tumors. In cases of CRC without proven MMR‐germline mutation, molecular analyses are warranted to confirm or rule out other familial CRC syndromes. This article describes the cases of two young male patients, who presented with locally advanced and metastatic CRC, and reports the results of the germline mutational analyses done for both patients. These cases demonstrate the importance of special care and molecular diagnostic procedures for young patients with CRC.Key Points. Patients with colorectal cancer who are younger than 50 years at initial diagnosis (early onset) should routinely undergo genetic testing.Early‐ and very‐early‐onset patients (younger than 40 years) with absence of microsatellite instability should be considered for tumor mutation burden testing and/or DNA polymerase proofreading mutation.The mutational signature of HSP110 within mismatch repair deficiency‐related tumors may help to identify patients likely to benefit from 5‐fluorouracil‐based chemotherapy.Intensified, maintained, and specific surveillance may help to reduce secondary tumor progression.

http://bit.ly/2Uc1YOm

Topical pimecrolimus versus betamethasone for oral lichen planus: a randomized clinical trial

Abstract

Objectives

Oral lichen plans (OLP) is a potentially malignant inflammatory mucocutaneous disease. CD133 is an investigated surface marker for cancer stem-like cells (CSCs) that may be involved in tumor initiation in head and neck carcinomas. We compared short-term clinical effectiveness of topical pimecrolimus as selective inflammatory cytokine release inhibitor with betamethasone cream for erosive/atrophic OLP and investigated the influence of this therapy on CD133 expression.

Material and methods

Thirty patients were randomly assigned into two equal groups to receive topical pimecrolimus (group I) or betamethasone (group II) four times daily for 4 weeks. A marker lesion in each patient were assessed at baseline using clinical score (CS) and visual analog scale (VAS) then at 1, 2, and 4 weeks and after 4 weeks of treatment-free period. CD133 expression was detected in pre- and post-treatment immunostained sections.

Results

Both drugs showed a reduction in CS, VAS, and CD133 expressions after treatment termination (p < 0.001). Pimecrolimus-treated lesions showed significant higher 1st week reduction in severity (33.1% (22.2)), pain score (57.53% (14.27)), less recurrence in follow-up period and less CD133 expression by the end of the 1st 4 weeks compared with betamethasone.

Conclusion

Pimecrolimus showed earlier clinical response and less recurrence rate compared with standard topical corticosteroid in symptomatic OLP lesions, and both treatment reduced CD133-positive CSC population.

Clinical relevance

The study proved the benefits of topical pimecrolimus in early management of painful lesions of OLP and its ability to inhibit CSCs, suggesting a possible role in reducing risk of malignant transformation.



http://bit.ly/2RbPjZT

Remineralization capacity of carious and non-carious white spot lesions: clinical evaluation using ICDAS and SS-OCT

Abstract

Objectives

To assess the remineralization capacity of carious, non-carious, and combined white spot lesions (WSLs) using the ICDAS and SS-OCT.

Materials and methods

This clinical trial was based on a quasi-experimental design. Forty-two healthy subjects (median age 26.6 years), who visited university hospital and had at least one WSL with an ICDAS score of 2 or 1, were recruited. The subjects chewed a non-blind sugar-free gum containing bioavailable calcium and fluoride for 3 months. The remineralization capacities of carious and non-carious 121 WSLs were assessed using ICDAS by two calibrated non-blind examiners and optical boundary depth (BD) by SS-OCT at a monthly recall. The outcome variables, transitions of ICDAS score, mean BD, and mean BD recovery rate (RR%), were statistically analyzed using the chi-square test, two way-repeated measures ANOVA, and Wilcoxon rank sum test, respectively (alpha = 0.05).

Results

Based on the visual inspection, OCT images at the baseline, 72 WSLs were purely carious, 20 were non-carious (developmental) lesions, while 29 were combined (carious-developmental). The responses of WSLs over time showed to be highly variable. There was a significant difference in transitions of ICDAS scores after 3 months between carious and non-carious WSLs (p < 0.05) and non-carious and combined WSLs (p < 0.05). Carious and combined WSLs underwent significant changes in the mean BD between baseline (161.8 ± 56.8 μm) and 2 months (130.7 ± 57.4 μm) or 3 months (119.1 ± 57.5 μm) (p < 0.05), while there was no significant difference between baseline (132.2 ± 26.2 μm) and 2 months (122.8 ± 24.1 μm) or 3 months (119.8 ± 22.6 μm) in non-carious WSLs (p > 0.05). There was a significant difference in mean RR% after 2 and 3 months between carious and non-carious WSLs (p < 0.05).

Conclusions

The remineralization capacity of WSL was variable among the cases and subjects, and depended on the WSLs history, etiology (carious, non-carious, or combined lesion) and structure (histological pattern).

Clinical relevance

Carious WSLs showed the highest remineralization potential.



http://bit.ly/2Wjn5QB

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