Clinical trials (Health Sciences)

Patient-related barriers have hindered cancer
patients' abilities to participate in the decision-making processes
to participate in clinical trials. However, little is known about patients' emotional barrier of fear and how physicians influence this barrier. We conducted 48 in-depth interviews with cancer patients to determine their knowledge and attitudes about participating in clinical trials, transcribed interviews verbatim, and qualitatively analyzed the transcripts using content analysis. For the purpose of this manuscript, we focused on findings related to the role of the emotional barrier of fear in cancer patients' perceptions of participating in clinical trials. The majority of cancer patients (n=40, 83.3%) discussed fears surrounding clinical trials, particularly as it related to cancer diagnosis, clinical trial participation, and fear of the unknown. In conclusion, providers might consider addressing the role of fear in patients' considering participating in a clinical trial.

Background: Informed consent is a basic concept of contemporary, autonomy-based medical practice and facilitates a shared decision-making model for relations between physicians and patients. Thus, the extent to which patients can comprehend the consent they grant is essential to the ethical viability of medicine as it is pursued today. However, research on patients' comprehension of an informed consent's basic components shows that their level of understanding is limited. Methods: Systemic searches of the PubMed and Web of Science databases were performed to identify the literature on informed consent, specifically patients' comprehension of specific informed consent components. Results: In total, 14 relevant articles were retrieved. In most studies, few clinical trial participants correctly responded to items that examined their awareness of what they consented to. Participants demonstrated the highest level of understanding (over 50%) regarding voluntary participation, blinding (excluding knowledge about investigators' blinding), and freedom to withdraw at any time. Only a small minority of patients demonstrated comprehension of placebo concepts, randomisation, safety issues, risks, and side effects. Conclusions: We found that participants' comprehension of fundamental informed consent components was low, which is worrisome because this lack of understanding undermines an ethical pillar of contemporary clinical trial practice and questions the viability of patients' full and genuine involvement in a shared medical decision-making process.

Context: According to Persian medicine text, there are some topical herbal remedies for insomnia such as pumpkin oil as a nasal drop.

Aims: To evaluate the effect of pumpkin oil (a Persian medicine product) in patients with chronic insomnia.

Methods: This study was conducted as a randomized double-blind clinical trial on pumpkin oil efficacy in 74 patients with chronic insomnia. The participants received two drops of intranasal pumpkin oil or placebo every night for two weeks. The effects of pumpkin oil and placebo on the pattern of sleep and sleep quality were assessed at baseline and at the end of two weeks of treatment by Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) questionnaires.

Results: The scores of the ISI questioner were statistically different between groups after two weeks of intervention and patients in the pumpkin oil group had fewer scores for ISI questioner (p<0.001). The reduction of the total score of the Pittsburgh questioner was 10.08 ± 3.21 in the pumpkin oil group and 0.28 ± 0.98 (p<0.001) in the control group.

Conclusions: Pumpkin oil could have a significant positive effect on the quantity and the quality of sleep in patients with chronic insomnia.

Many tumor cells become resistant to commonly used cytotoxic drugs due to the overexpression of ATP-binding cassette (ABC) transporters, namely P-glycoprotein (P-gp). The discovery of the reversal of multidrug resistance (MDR) by verapamil occured in 1981, and in 1968 MDR Chinese hamster cell lines were isolated for the first time. Since then, P-gp inhibitors have been intensively studied as potential MDR reversers. Initially, drugs to reverse MDR were not specifically developed for inhibiting P-gp; in fact, they had other pharmacological properties, as well as a relatively low affinity for MDR transporters. An example of this first generation P-gp inhibitors is verapamil. The second generation included more specific with less side-effect inhibitors, such as dexverapamil or dexniguldipine. A third generation of P-gp inhibitors comprised compounds such as tariquidar, with high affinity to P-gp at nanomolar concentrations. These generations of inhibitors of P-gp have been examined in preclinical and clinical studies; however, these trials have largely failed to demonstrate an improvement in therapeutic efficacy. Therefore, new and innovative strategies, such as the fallback to natural products, the design of peptidomimetics and dual activity ligands emerged as a fourth generation of P-gp inhibitors. The chemistry of P-gp inhibitors, as well as their in vitro, in vivo and clinical trials are discussed, and the most recent advances concerning Pgp modulators are reviewed.

Background: Although the headgear appliance has been used extensively to correct anteroposterior discrepancies, its treatment effects have not yet been adequately assessed in an evidence-based manner. Objective: Aim of this systematic review was to assess the therapeutic and adverse effects of early headgear treatment from controlled clinical trials on human patients in an evidence-based manner. Search methods: An unrestricted electronic search of six databases from inception to December 2015. Selection criteria: Randomized and prospective non-randomized controlled trials assessing the effects of headgear treatment on human patients. Data collection and analysis: After duplicate study selection, data extraction, and risk of bias assessment according to the Cochrane guidelines, random-effects meta-analyses of mean differences (MDs) and relative risks (RRs), including their 95% confidence intervals (CIs) were performed, followed by subgroup and sensitivity analyses. Results: A total of 18 unique studies with a total of 930 (56% male/44% female) patients were included. Headgear treatment was associated with a posterior translation of the anterior maxilla border in the short term, as seen by the mean annualized change in the SNA angle (MD = −1.63°/ year; 95% CI = −2.20 to −1.06°/year; high quality evidence) compared to untreated patients. This effect was independent of the rotation of the palatal plane and the inclination of the upper incisors, while a proportional relationship with the initial discrepancy in SNA was seen. The clinical significance of this improvement diminished in the long term, although only limited evidence existed. Additionally, early headgear treatment might decrease the risk of dental trauma during the following years (RR = 0.34; 95% CI = 0.14 to 0.80; moderate quality evidence). Low quality evidence on the effect of headgear on the rotation of the palatal plane, the nasolabial angle, the occlusal outcome, and signs of temporomandibular disorders precluded robust assessments, due to risk of bias, inconsistency, imprecision, and small-study effects. Conclusions: Based on existing trials, headgear is a viable treatment option to modify sagittal growth of the maxilla in the short term in Class II patients with maxillary prognathism. Registration: PROSPERO (CRD42015029837). Funding: None.

Leaders should be competent in managing disaster situations to minimize the damage of the events. However, when disaster strikes these leadership competencies may not always come into play. This paper aims to identify the incongruence between what leaders should do and what leaders do when managing real disasters and what can be learned from it. This paper reviews the Aceh Earthquake and Tsunami disaster in 2004 and the Fukushima Nuclear Disaster in 2011, as case studies. Published and grey literatures relating to these events were searched from online sources. Two major mismatches between leadership theory and reality were noted: effective communication and ability to co-ordinate resources at all levels. To improve leadership in disaster management, mitigation measures, preparedness and skills in crisis communication must be top-notch, communication disruption must be overcomed as soon as possible; and all entities involved in disaster management must know their roles. 

Review Soft tissue changes following extraction vs. nonextraction orthodontic fixed appliance treatment: a systematic review and meta-analysis Konstantonis D, Vasileiou D, Papageorgiou SN, Eliades T. Soft tissue changes following extraction vs. nonextraction orthodontic fixed appliance treatment: a systematic review and meta-analysis. Eur J Oral Sci 2018; 00: 1–13. © 2018 Eur J Oral Sci The aim of this systematic review was to assess the effect of systematic extraction protocols during orthodontic fixed appliance treatment on the soft tissue profile of human patients. Nine databases were searched until December 2016 for controlled clinical studies including premolar extraction or nonextraction treatment. After elimination of duplicate studies, data extraction, and risk-of-bias assessment according to the Cochrane guidelines, random-effects meta-analyses of mean differences (MD) or standardized mean differences (SMD) and their 95% CIs were performed, followed by subgroup, meta-regression, and sensitivity analyses. Extraction treatment was associated with increased lower lip retraction (24 studies; 1,456 patients; MD = 1.96 mm), upper lip retraction (21 studies; 1,149 patients; MD = 1.26 mm), nasolabial angle (21 studies; 1,089 patients; MD = 4.21°), soft-tissue profile convex-ity (six studies; 408 patients; MD = 1.24°), and profile pleasantness (three studies; 249 patients; SMD = 0.41). Patient age, extraction protocol, and amount of upper incisor retraction during treatment were significantly associated with the observed extraction effects, while the quality of evidence was very low in all cases due to risk of bias, baseline confounding, inconsistency, and imprecision. Although tooth extractions seem to affect patient profile, existing studies are heterogenous and no consistent predictions of profile response can be made.

Objective: The aim of this systematic review was to assess the occlusal outcome and duration of fixed orthodontic therapy from clinical trials in humans with the Objective Grading System (OGS) proposed by the American Board of Orthodontics. Methods: Nine databases were searched up to October 2016 for prospective/ retrospective clinical trials assessing the outcomes of orthodontic therapy with fixed appliances. After duplicate study selection, data extraction, and risk of bias assessment according to the Cochrane guidelines, random-effects meta-analyses of the mean OGS score and treatment duration were performed and 95% confidence intervals (CIs) were calculated. Results: A total of 34 relevant clinical trials including 6,207 patients (40% male, 60% female; average age, 18.4 years) were identified. The average OGS score after treatment was 27.9 points (95% CI, 25.3–30.6 points), while the average treatment duration was 24.9 months (95% CI, 24.6–25.1 months). There was no significant association between occlusal outcome and treatment duration, while considerable heterogeneity was identified. In addition, orthodontic treatment involving extraction of four premolars appeared to have an important effect on both outcomes and duration of treatment. Finally, only 10 (39%) of the identified studies matched compared groups by initial malocclusion severity, although meta-epidemiological evidence suggested that matching may have significantly influenced their results. Conclusions: The findings from this systematic review suggest that the occlusal outcomes of fixed appliance treatment vary considerably, with no significant association between treatment outcomes and duration. Prospective matched clinical studies that use the OGS tool are needed to compare the effectiveness of orthodontic appliances. [Korean J Orthod 2017;47(6):401-413]

Ethnopharmacological relevance: In Persian ethnomedicine several herbal remedies and functional foods have been used to treat migraine headache which are mostly summarized in Qarabadin-e-kabir (Aghili-Shirazi MH, 1773). One of them is Citron syrup (Sharbat-e-Balang) containing edible Citrus medica L. fruit juice and sugar. The present study was designed to assess the efficacy and safety of Citron syrup on patients with migraine headache. Materials and methods: Citron syrup was prepared as described in Qarabadin-e-kabir. In this double blind randomized placebo-controlled clinical trial, ninety patients with migraine headache were allocated to three parallel groups (Citron syrup, propranolol or placebo). Patients received 15 ml of Citron syrup, placebo syrup or 20 mg of propranolol tablet three times daily after a meal for 4 weeks. Primary outcomes were obtained from three measures: the frequency (per month), mean duration (hour) and mean intensity (visual analogue scale "VAS" 0-10 score) of headache attacks evaluated prior to and following 4 weeks of the intervention. Results: Citron syrup was superior to placebo in reduction of headache attacks intensity (P o0.01) and duration (po 0.0001) and as effective as propranolol in patients with migraine headache (P4 0.05). However, unlike propranolol, Citron syrup could not significantly reduce the frequency of attacks compared to placebo. No indication of any serious side effects from Citron syrup was observed. Conclusion: According to obtained results, Citron syrup as a traditional Persian remedy can be suggested as an effective treatment for decreasing pain intensity and duration of attacks in migraine headache and the effectiveness is comparable to propranolol. However, the syrup did not show significant effect on frequency of attacks.

"The clinical bacteria of multi-drug resistant to some antibiotics are
considered a common problem in the world wide. Alternative
antibacterial strategies are urgently needed, and thus this situation
has led to a re-evaluation of the therapeutic use of ancient
remedies, such as plants and plant-based products, including
Nigella sativa (N. sativa). This study aimed to evaluate the
antibacterial activity of Yemeni N. sativa oil against some Clinical
Bacterial Isolates (CBI) and Control Strains of Bacteria (CSB) in
comparison with Augmentin® (Amoxicillin and Clavulanic Acid).
This study was carried out in Sana’a city during the period of one
year from May 2012 to April 2013. The antibacterial activity of oil
with different concentrations was determined by using disc agar
diffusion technique against CBI (Staphylococcus aureus and
Pseudomonas aeruginosa) and CSB (Staphylococcus aureus
ATCC25619, Pseudomonas aeruginosa ATCC29737), also the
Minimum Inhibition Concentration (MIC) of oil extract was
determined. The results indicated that, the highest significant
antibacterial activity was at the maximum concentration of the oil
against Staphylococcus aureus and Pseudomonas aeruginosa in
comparison with Augmentin ® discs (p < 0.05) respectively. This
study observed that, there was strong positive correlation between
the diameter zone (DZ-mm) and oil concentrations (%). In
addition, the DZ (mm) of the oil for CSB was higher than CBI.
Also the oil activity was found to be more effective against
Staphylococcus aureus than Pseudomonas aeruginosa. On the
other hand, the MIC of the oil against CBI were ranged between ≥
0.5% and 4%. Whereas, the CSB particularly Staphylococcus
aureus were sensitive to low concentrations of oil. It could be
concluded that, the oil had high antibacterial effect against CSB
and CBI with high concentration and more effective than
Augmentin® discs."

Introduction: Low health literacy (HL) is one of the contributing factors that leads to negative diabetic outcome. Quality of life (QOL) is a state of complete physical, mental and social wellbeing. There is limited evidence on association of HL and QOL among type 2 diabetes mellitus (T2DM), therefore the objectives of this study were to identify the HL and QOL status, to determine the association between HL and QOL and factors associated with QOL among T2DM patients. Methods: This was a cross sectional study involving patients with T2DM from two public primary care clinics. HL and QOL were measured using translated and validatedHLS – Asia Q16 and DQoL-BCI questionnaires respectively among T2DM patients. Results: The mean HL score was 12.39 (3.34), 17.7 % had “inadequate HL”, 25.7% had “problematic HL” and 56.6% had “sufficient HL”. The mean DQoL-BCI score was 32.09 (6.51). Lower QOL level was negatively associated with age (b -0.140; CI: -0.190, - 0.090; p&lt;0.001), not obese (b...

irca il 30% dei pazienti che vengono ricoverati in terapia intensiva sono affetti da insufficienza respiratoria acuta (ARF) e vengono sottoposti a ven-tilazione meccanica, e > 90% viene ventilato mediante tubo endotracheale. 1 Tuttavia, l'adozione di una via aerea artificiale per garantire la ventilazione 34 Articoli originali ; per conto degli sperimentatori EMVIRA † C Obiettivo dello studio: La ventilazione meccanica non invasiva (NIMV) risulta vantaggiosa nel trattamento dell'insufficienza respiratoria acuta (ARF), associata alla terapia medica standard. Tuttavia rimane controverso il suo impiego in alternativa alla ventilazione meccanica tradizionale (CMV). Contributo del nostro lavoro è confrontare l'efficacia e il dispendio di risorse nell'utilizzo della NIMV e della CMV nel trattamento di pazienti con ARF. Disegno: Studio multicentrico controllato randomizzato.

Occupational diseases are one of the major health problems related to workplace hazards. However, the epidemiological data for this problem is scarce especially among Small and Medium Industry (SMI) workers. These workers are vulnerable to occupational health problem due to lack of knowledge and implementation of health and safety in the workplace. In Malaysia, most of the SMI workers have limited coverage for basic occupational health services which may worsen their health. Thus, this article aims to provide a review on the burden of occupational health problems among them. The electronic and library searches were used to extract the information from both published and unpublished articles that were not limited to any year of publication until 2017. One hundred and ninety-six published articles and 198 unpublished articles were retrieved from the database. Only 19 published articles and 25 unpublished articles met the eligibility criteria. Prevalence data of occupational diseases/p...

How to obtain copies of this and other HTA programme reports An electronic version of this title, in Adobe Acrobat format, is available for downloading free of charge for personal use from the HTA website (www.hta.ac.uk). A fully searchable DVD is also available (see below).

KEYWORDS Organophosphorous, Pesticides, Malondialdehyde, Reduced glutathione, Serum total antioxidant Capacity, L-carnitine. Organophosphorus compounds are widely used pesticides. They are associated with a significant risk of acute intoxication. Oxidative stress is a contributing factor of acute organophosphorus poisoning morbidity and mortality. L-carnitine was found to have free-radical scavenging and antioxidant properties. Therefore, we aimed to evaluate the efficacy and safety of L-carnitine as an adjuvant in treatment of patients with acute organophosphorus poisoning. A randomized clinical trial was conducted on 30 patients suffering from acute organophosphorus poisoning admitted to Poison Control Center, Tanta University Emergency Hospital, Egypt, from April 2017 till January 2018. Patients were randomly divided into two equal groups. Group I received the standard treatment only and group II received the standard treatment plus L-carnitine in a dose of 1gm/8 hours IV.At time of admission, malondialdehyde, reduced glutathione, serum total antioxidant capacity and psudocholinesterase enzyme activity registered no significant difference between the two studied groups. After treatment, malondialdehyde, reduced glutathione and serum total antioxidant capacity showed significant improvement in group II. The mean value of atropine dose in group II (5.6mg) was significantly lower than group I(10.9mg). We concluded that the use of L-carnitine improved the antioxidant status and reduced total atropine dose required for treatment of patients with acute organophosphorus poisoning.

Background-Little is known about the relationship between attention-deficit/hyperactivity disorder (ADHD) subtypes and substance-use disorder (SUD). As there is literature suggesting different subtype phenotypes, there may be subtype differences in regard to the risk for developing SUD and substance treatment response.

Tuberculosis (TB), an ongoing public health threat, is worsened by the emergence of drug resistance. With an estimated 630000 cases per year of multidrug resistant (MDR)-TB, and 9% of those being extensively drug resistant (XDR)-TB, there is an urgent need for new and more effective anti-TB drugs. New TB treatment regimens should be able to shorten the duration of therapy that currently takes at least six months. The non-compliance with this long treatment duration is one of the reasons for the development of drug resistance. In spite of the difficulties and alleged lack of interest from the pharmaceutical industry for the discovery and development of new antibiotics, several new or repurposed drugs are being evaluated in clinical trials. This review article summarizes the information available and presents an update on the drugs currently in clinical trials for TB and briefly introduces some new compounds in pre-clinical development.

Introduction: Parents play an essential role in the success of their children’s tuberculosis (TB) treatment. They faced many challenges from the initial children’s health status changes until completing the TB treatment. The challenges were also described as perceived barriers, according to the Health Belief Model (HBM). This study aims to explore parents’ experiences on the challenges in achieving a successful TB treatment for their child in two districts of Selangor, Malaysia. Methods: The research was carried out using the phenomenology study design. In-depth interviews were conducted among purposely sample primary caregivers of children with TB disease who have completed TB treatment or still under treatment. MyTB version 2.1 data were sought from TB Unit, Selangor Health State Department for Klang and Petaling districts. The participants were selected based on the registration year of 2017 to 2019. The collected data was considered as achieving its saturation level if no new th...

Clinical trial adaptation refers to any adjustment of the trial protocol after the onset of the trial. The main goal is to make the process of introducing new medical interventions to patients more efficient by reducing the cost and the time associated with evaluating their safety and efficacy. The principal question is how should adaptation be performed so as to minimize the chance of distorting the outcome of the trial. We propose a novel method for achieving this. Unlike previous work our approach focuses on trial adaptation by sample size adjustment. We adopt a recently proposed stratification framework based on collected auxiliary data and show that this information together with the primary measured variables can be used to make a probabilistically informed choice of the particular sub-group a sample should be removed from. Experiments on simulated data are used to illustrate the effectiveness of our method and its application in practice.

Context: According to Persian medicine text, there are some topical herbal remedies for insomnia such as pumpkin oil as a nasal drop. Aims: To evaluate the effect of pumpkin oil (a Persian medicine product) in patients with chronic insomnia. Methods: This study was conducted as a randomized double-blind clinical trial on pumpkin oil efficacy in 74 patients with chronic insomnia. The participants received two drops of intranasal pumpkin oil or placebo every night for two weeks. The effects of pumpkin oil and placebo on the pattern of sleep and sleep quality were assessed at baseline and at the end of two weeks of treatment by Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) questionnaires. Results: The scores of the ISI questioner were statistically different between groups after two weeks of intervention and patients in the pumpkin oil group had fewer scores for ISI questioner (p&lt;0.001). The reduction of the total score of the Pittsburgh questioner was 10.0...

Medical records for a patient's medical information were written on paper with the details of their medical history and care, but they were not in widespread use until 1900-1920 [1]. Physicians have to go through all paper charts to search for relevant information for the patients. They may end up not finding any information linked to the disease because these records on paper have restrictions on retrieving information and being limited with information. The writings of medical records have evolved to be maintained in a computer system to make it convenient for physicians [2]. Data is a valuable asset in the calibration, validation, and evaluation of any condition, and it plays a critical role in comprehending the

academic foundation trainee 1 , Bryony Shelton medical student 2 , Humza Mahmood medical student 3 , J Edward Fitzgerald general surgery registrar 4 , Ewen M Harrison senior lecturer in general surgery 5 , Aneel Bhangu clinical lecturer in colorectal surgery 2

Objective:  Childhood  asthma  is  a  common  and  potentially  life-threatening  condition  and  a  leading  cause  of  child  admission  to  acute  care and emergency services. The importance of educational methods for children and their parents about appropriate asthma management has  been  highlighted  in  many  studies,  but  little  is  known  about  the  effectiveness  of  educational  methods.  This  study  aims  to  evaluate  the  effectiveness of group education intervention on asthma in secondary care settings compared with face-to-face education for children (under 18) and their parents. Specifically, it assesses the number of emergency visits, hospital admissions, school absences, quality of life, mortality and cost to provide best evidence for future clinical research and practice.Data sources: MEDLINE, CINHAL, PsycINFO, EMBASE, Web of Science, and SCOPUS databases. Study selections: 15 RCTs identified and their methodological quality assessed using JBI-MAStRI checklist. Results: 15 of 927 studies included in the final review (with reviewer consensus) indicated a significant reduction in number of emergency visits  and  hospital  admissions  among  those  receiving  face-to-face.  Two  studies  highlighted  the  mean  number  of  school  absences;  one  study  measured QoL of asthmatic children and their parents, four calculated the health cost of education and none considered mortality rates. Conclusion: Face-to-face education significantly reduces asthmatic children’s emergency visits and hospital admissions.

Effective medical treatments of infertile men with idiopathic oligoasthenoteratospermia (OAT) have yet to be determined. This study considered two major aims: (i) to measure the changes in semen parameters, omega-3 fatty acids (FA) compositions and anti-oxidant activity; (ii) to determine if the administration of omega-3 FA affect semen quality in infertile men with OAT. Two hundred thirty-eight infertile men with idiopathic OAT were randomised to eicosapentaenoic (EPA) and docosahexaenoic acids (DHA), 1.84 g per day (EPAX 5500TG; Lysaker, Norway), or placebo for 32 weeks. The semen parameters were assessed according to WHO criteria, and the EPA and DHA concentrations were determined in red blood cells (RBCs), seminal plasma and sperm cells at baseline and 32-week treatment period. Of randomised subjects, 211 (88.7%) completed the full 32-week randomisation period. The anti-oxidant status of seminal plasma was also evaluated by measuring the superoxide dismutase (SOD) and catalase-like activity. In the total group of participants, all EPA and DHA levels in RBC, and seminal plasma, were statistically significantly correlated with those in spermatozoa (both P = 0.001). A significant improvement of sperm cell total count (from 38.7 ± 8.7 ' 10⁶ to 61.7 ± 11.2 ' 10⁶, P = 0.001) and sperm cell concentration (from 15.6 ± 4.1 ' 10⁶ per ml to 28.7 ± 4.4 ' 10⁶ per ml, P = 0.001) was observed in the omega-3 group. A significant positive correlation was found between the EPA and DHA in seminal plasma and the semen parameters. Seminal plasma EPA and DHA concentrations were positively correlated with seminal plasma SOD-like and catalase-like activity (both P = 0.001). In seminal plasma, both SOD-like and catalase-like activity were positively correlated with sperm count, sperm motility, and sperm morphology. Oligoasthenoteratospermic men with low levels of EPA and DHA may benefit from omega-3 FA supplementation. Further studies are warranted to shed more light on this important issue.

We propose a novel adaptive design for clinical trials with time-to-event outcomes and co-variates (which may consist of or include biomarkers). Our method is based on the expected entropy of the posterior distribution of a proportional hazards model. The expected entropy is evaluated as a function of a patient's covariates, and the information gained due to a patient is defined as the decrease in the corresponding entropy. Candidate patients are only recruited onto the trial if they are likely to provide sufficient information. Patients with covariates that are deemed uninformative are filtered out. A special case is where all patients are recruited, and we determine the optimal treatment arm allocation. This adaptive design has the advantage of potentially elucidating the relationship between covariates, treatments, and survival probabilities using fewer patients, albeit at the cost of rejecting some candidates. We assess the performance of our adaptive design using data from the German Breast Cancer Study group and numerical simulations of a biomarker validation trial.

Reports on post-surgical pain are a few, controversial and flawed (by statistics and analgesic consumption). Besides, it is not known if chlorhexidine can reduce post-extraction pain adjusting for its effect on prevention of infection and dry socket (DS). We assessed these. A total of 90 impacted mandibular third molars of 45 patients were extracted. Intra-alveolar 0
2% chlorhexidine gel was applied in a split-mouth randomised design to one-half of the sockets. None of the included patients took antibiotics or analgesics afterwards. In the first and third post-operative days, DS formation and pain levels were recorded. Predictive roles of the risk factors were analysed using fixed-effects (classic) and multilevel (mixed-model) multiple linear regressions ( a = 0
05, b≤ 0
1). In the first day, pain levels were 5
56  1
53 and 4
78  1
43 (out of 10), respectively. These
reduced to 3
22  1
41 and 2
16  1
40. Pain was more intense on the control sides [both P values = 0
000 (paired t -test)]. Chlorhexidine had a significant pain-alleviating effect ( P = 0
0001),
excluding its effect on DS and infection. More difficult surgeries ( P = 0
0201) and dry sockets were more painful ( P = 0
0000). Age had a marginally significant negative role ( P = 0
0994). Gender and smoking had no significant impact [ P ≥ 0
7 (regression)]. The pattern of pain reduction differed between dry sockets and healthy sockets [ P = 0
0102 ( ANOVA )]. Chlorhexidine can reduce pain, regardless of its infection-/DS-preventive
effects. Simpler surgeries and sockets not affected
by alveolar osteitis are less painful. Smoking and
gender less likely affect pain. The role of age was
not conclusive and needs future studies.
KEYWORDS: tooth extraction, impacted teeth, post-
operative pain, risk factors, chlorhexidine gel

Sub-contracting in clinical trials proves to have privileges in comparison to other projects. In Horizon 2020 projects, core activities cannot be sub-contracted. When it comes to peripheral activities, although it is possible to assign work to sub-contractors (while ensuring “best value for money”), it is still known to be frowned upon by the EC. The rationale behind this is rather simple – the official beneficiaries are responsible and liable to their own financial management vis-a-vis the EC via a contractual relationship (the Grant Agreement). But when it comes to sub-contractors the situation is different: The EC does not have a direct contractual relationship with them, hence limited ability to monitor their performance.  Therefore, in most areas of Horizon 2020 it is highly recommended to avoid or reduce the work delegated to sub-contractors.

The outbreak of novel coronavirus disease 2019 (COVID-19) has been declared a Public Health Emergency of International Concern by the World Health Organization. The incidence of this pandemic continues to rise, with 40,665,438 confirmed cases and 1,121,843 deaths worldwide by 21 October 2020. During this public health crisis, healthcare workers are at the frontline of the COVID-19 outbreak response, and as such are at risk of being infected and developing job burnout while in the line of duty. This study reviews the history of COVID-19 outbreak, infection control measures in hospitals during COVID-19 outbreak, healthcare workers’ risk of infection and other health effects from battling COVID-19, and challenges and recommendations for protecting healthcare workers during this pandemic. At present, healthcare workers are every country’s most valuable resources, and their safety must thus be ensured. Strong medical leadership, clear pandemic planning, policies and protocols, continuous...

Introduction: Hormonal abnormality is one of many clinical manifestations of HIV infections that is not well understood. However, the consequences could affect quality of life and are potentially treatable. Thus, this study aimed to determine the prevalence and associated factors of thyroid, adrenal and gonadal dysfunctions among HIV-infected patients. Methods: This is a single centre cross-sectional study involving 150 HIV-infected patients attending the HIV clinic. Each subject was required to answer specific symptoms questionnaire and their medical records were reviewed for relevant clinical and biochemical data. Blood for was collected and thyroid hormones, cortisol, ACTH, FSH, LH, testosterone and estradiol were analysed using electrochemiluminescent immunoassay. Thyroid, adrenal and gonadal axes abnormalities were identified. Results: Hypogonadism had the highest prevalence amongst the endocrine abnormalities, which was detected in 23 patients (15.3%), followed by thyroid dysf...

Introduction: Low health literacy (HL) is one of the contributing factors that leads to negative diabetic outcome. Quality of life (QOL) is a state of complete physical, mental and social wellbeing. There is limited evidence on association of HL and QOL among type 2 diabetes mellitus (T2DM), therefore the objectives of this study were to identify the HL and QOL status, to determine the association between HL and QOL and factors associated with QOL among T2DM patients. Methods: This was a cross sectional study involving patients with T2DM from two public primary care clinics. HL and QOL were measured using translated and validatedHLS – Asia Q16 and DQoL-BCI questionnaires respectively among T2DM patients. Results: The mean HL score was 12.39 (3.34), 17.7 % had “inadequate HL”, 25.7% had “problematic HL” and 56.6% had “sufficient HL”. The mean DQoL-BCI score was 32.09 (6.51). Lower QOL level was negatively associated with age (b -0.140; CI: -0.190, - 0.090; p&lt;0.001), not obese (b...

The specialty of family medicine is centered on lasting, caring relationships with patients and their families. Family physiciansintegrate the biological, clinical and behavioral sciences to provide continuing and comprehensive health care. The scope of family medicine encompasses all ages, sexes, each organ system and every disease entity. Read more about the history, scope and definition of family medicine by reviewing the following resources.



Public-health-family-medicine



Family medicine is a three-dimensional specialty, incorporating (1) knowledge, (2) skill and (3) process. At the center of the process element is the patient-physician relationship with the patient viewed in the context of the family. It is the extent to which this relationship is valued, developed, nurtured and maintained that distinguishes family medicine from all other specialties.



Family physicians integrate the biological, clinical and behavioral sciences to provide continuing and comprehensive health care. Family medicine encompasses all ages, sexes, each organ system and every disease entity. Family physicians also pay special attention to their patients' lives within the context of family and the community.

Adolescent Medicine
Geriatric Medicine
Pain Medicine
Sleep Medicine
Sports Medicine
Sexual Health
Geriatric Medicine
For more details, PS: https://clinicalcasereports.conferenceseries.com/events-list/case-reports-on-public-health-family-medicine

Stem cell therapy in recent years has gained much attention as the modern therapeutic approach to treat diseases. Mesenchymal stem cells (MSCs) are seen as the most reliable cells applied in therapy over other stem cells because of their versatility. Bone and cartilage diseases (osteo-diseases) are the major target of therapy using MSCs. In this perspective, we have statistically analyzed the data available on clinical trials registry databases regarding the mesenchymal stem cell based therapy for a number of mentioned diseases and paid attention towards the osteodiseases. We report that MSC therapy for osteodiseases needs optimization in its standards to achieve acceptable results so that we can apply it in daily routine clinical practice.

Stem/progenitor cell-based therapeutic approach in clinical practice has been an elusive dream in medical sciences, and improvement of stem cell homing is one of major challenges in cell therapy programs. Stem/progenitor cells have a homing response to injured tissues/organs, mediated by interactions of chemokine receptors expressed on the cells and chemokines secreted by the injured tissue. For improvement of directed homing of the cells, many techniques have been developed either to engineer stem/progenitor cells with higher amount of chemokine receptors (stem cell-based strategies) or to modulate the target tissues to release higher level of the corresponding chemokines (target tissue-based strategies). This review discusses both of these strategies involved in the improvement of stem cell homing focusing on mesenchymal stem cells as most frequent studied model in cellular therapies.

Objective
To determine the rate of early discontinuation and non-publication of randomised controlled trials involving patients undergoing surgery.

Design
Cross sectional observational study of registered and published trials.

Setting
Randomised controlled trials of interventions in patients undergoing a surgical procedure.

Data sources
The ClinicalTrials.gov database was searched for interventional trials registered between January 2008 and December 2009 using the keyword “surgery”. Recruitment status was extracted from the ClinicalTrials.gov database. A systematic search for studies published in peer reviewed journals was performed; if they were not found, results posted on the ClinicalTrials.gov results database were sought. Email queries were sent to trial investigators of discontinued and unpublished completed trials if no reason for the respective status was disclosed.

Main outcome measures
Trial discontinuation before completion and non-publication after completion. Logistic regression was used to determine the effect of funding source on publication status, with adjustment for intervention type and trial size.

Results
Of 818 registered trials found using the keyword “surgery”, 395 met the inclusion criteria. Of these, 21% (81/395) were discontinued early, most commonly owing to poor recruitment (44%, 36/81). The remaining 314 (79%) trials proceeded to completion, with a publication rate of 66% (208/314) at a median time of 4.9 (interquartile range 4.0-6.0) years from study completion to publication search. A further 6% (20/314) of studies presented results on ClinicalTrials.gov without a corresponding peer reviewed publication. Industry funding did not affect the rate of discontinuation (adjusted odds ratio 0.91, 95% confidence interval 0.54 to 1.55) but was associated with a lower odds of publication for completed trials (0.43, 0.26 to 0.72). Investigators’ email addresses for trials with an uncertain fate were identified for 71.4% (10/14) of discontinued trials and 83% (101/122) of unpublished studies. Only 43% (6/14) and 20% (25/122) replies were received. Email responses for completed trials indicated 11 trials in press, five published studies (four in non-indexed peer reviewed journals), and nine trials remaining unpublished.

Conclusions
One in five surgical randomised controlled trials are discontinued early, one in three completed trials remain unpublished, and investigators of unpublished studies are frequently not contactable. This represents a waste of research resources and raises ethical concerns regarding hidden clinical data and futile participation by patients with its attendant risks. To promote future efficiency and transparency, changes are proposed to research governance frameworks to overcome these concerns.

Background How best to provide the findings of research to study participants remains poorly understood.
Purpose We aimed to develop, deliver, and evaluate a consultative approach to inform provision of feedback about research findings to participants in the Oracle Children Study (OCS). The OCS had identified adverse outcomes for some children whose mothers had been prescribed antibiotics as part of a trial in pregnancy.
Methods An iterative process, including focus groups with OCS participants and consultation with other OCS stakeholders, was used to inform the development of a feedback package, including a results leaflet, for OCS participants. A questionnaire survey of participants’ reactions to receiving the results leaflet was conducted. The Kolmogorov–Smirnov two-sample test was used to compare responses between different groups of respondents. Analysis of open-ended comments on the questionnaire was based on the constant comparative method.
Results Three focus groups with study participants provided insight into the potential emotional impact of receiving the results and into how the results might most clearly be explained. Negotiations with other stakeholders identified other priorities, including the need for scientific credibility. These multiple needs had to be balanced. The results leaflet was posted to all 4676 UK OCS participants. Survey responses were received from 1124 (25%) of participants. They indicated that the feedback was mostly well received by participants. Those whose children were affected by conditions associated with increased risk from trial participation were more likely to experience emotional distress on receiving the trial results, but there was also evidence of some other unanticipated impacts.
Limitations This study is limited by the low response rate to the survey.
Conclusions Important lessons can be learned from using a consultative approach to developing feedback about research results for study participants. Especially where the findings are unwelcome, feedback development may involve methodological, ethical, emotional, and practical challenges, be resource-intensive, and need early planning.