International Journal of Clinical Trials

A day in the life of a clinical research nurse

Melanie L. Paglione — 2024-04-24

Have you ever wondered, what does a clinical research nurse (CRNs) do from day-to-day or week-to-week? This article will attempt to answer those questions by including what defines research, clinical research and a CRN. Topics will also include the roles in which CRNs are responsible for or can complete, the challenges they face and their importance in clinical trials. In additional, advantages of being a CRN will be reviewed and how this can powerfully change your view on the career and then stories from CRNs at two major academic research institutes will be reported and how lives are changed because of research nurses. If you read this article and determine that this path may be what you want to pursue or learn more about, the writer has included a section about training and certification which can be reviewed and explored. Also included is knowledge which is helpful to learn when exploring this topic.

Screening of herbal extracts for rapid effect on activity-induced knee joint discomfort: a randomized and placebo-controlled pilot study

Shalini Srivastava — 2024-02-23

Background: A feasibility study was conducted to investigate the effect of different proprietary extracts on joint discomfort associated with repeated episodes of physical activity.

Methods: A single-dose randomized, double-blind, placebo-controlled cross-over study was conducted in three phases with different extract combinations. Seventeen individuals aged 40-60 years with a history of knee joint pain aggravation on physical stress were randomized to receive the investigational product or the placebo in a 1:1 ratio. The primary outcome was the time taken to achieve meaningful pain relief (MPR) from baseline using a pain visual analog scale (VAS) compared to the placebo. The secondary outcomes were the pain intensity difference (PID) and joint discomfort at 1-, 2-, 3-, and 4-hours post-product administration and the time-weighted sum of pain intensity difference (SPID) over 4 hours compared to placebo.

Results: Participants in two out of eight investigational product groups achieved MPR successfully. The proprietary combination ZV-E (consisting of Z. officinale and V. negundo) showed the fastest pain reduction with more than 50% of the participants achieving meaningful relief. The BS-ZP (consisting of B. serrata + Z. officinale + P. lanceolata) group also had more than 50% of participants reporting MPR at 4 hours post-IP administration. Subsequently, the SPID was found to be lowest in the participants of above stated groups.

Conclusions: The proprietary combination of Z. officinale and V. negundo extracts, 200 mg could be a promising lead to conduct a further trial to investigate its effect on joint pain.

Tele-assessment of Berg balance scale, timed-up, go and box and block test in patients with chronic stroke: establishing agreement with the face-to-face assessment

Efthalia Panagiotopoulou — 2024-04-24

Background: The COVID-19 pandemic has triggered rapid adaptive actions in favor of remote interventions and clinical assessment methods. The reliability of functional tests used in remote assessment is limited in patients with chronic stroke. The aim of the study was to assess the inter-reliability of the Berg balance scale, the timed-up and go test, and the box and block test via remote assessment, in patients with chronic stroke.

Methods: Fifteen patients (8 men and 7 women) underwent a home-based teleassessment using a software platform and a center-based face-to-face assessment, on two consecutive days. The assessment order was randomized and conducted by an independent examiner. All participants were instructed regarding the use of the software platform, home equipment preparation, and safety issues

Results: Participants aged 50-70 years (mean 59.6±7.34) with an average of 4.8±2.5 years after stroke and a moderate degree of motor dependence (Barthel scale: mean 83±8.61 units) completed all tests in both assessment procedures without experiencing adverse events. The inter-reliability was moderate for the total BBS score: ICC=0.869 (95% CI: 0.616 to 0.955), excellent for the total time of the TUG: ICC=0.968 (95% CI: 0.907 to 0.989) as well as for the upper right and left arm scores of the BBT: ICC=0.974 (95% CI: 0.922 to 0.991) and ICC=0.966 (95% CI: 0.897 to 0.988), respectively.

Conclusions: Tele-assessment for BBS, TUG, and BBT appears moderate to excellent inter-reliability in functionally independent patients with chronic stroke.

Cheese positively affects serum osteocalcin levels, bone turnover markers and bone mineral density in cross-country skiers: a dose-response study

Helge Einar Lundberg — 2024-04-24

Background: Vitamin K₂-rich Jarlsberg Cheese is demonstrated to increase Osteocalcin and bone turnover markers in fertile women. The impact on endurance-trained young cross-country skiers (XCS) with elevated bone turnover remains unclear. Purpose of study was to estimate the optimal daily efficacy dose of Jarlsberg cheese to increase serum Osteocalcin level in young female and male XCS and estimate the Jarlsberg effect on bone turnover markers (BTMs) and bone mineral density (BMD).

Methods: In a parallel group study consisting of three design levels, 10 female and 10 male XCS were included, using Response Surface Pathway design. Blood samples were taken at each level for measurements of Osteocalcin, vitamin K_2,BTMs and other biochemical parameters. Resting metabolic rate (RMR), BMD, VO₂max and muscle strength were measured at start and at the end of the study.

Results: The Osteocalcin development with increasing dose of Jarlsberg cheese was almost parallel in both sexes. These variables were reduced significantly from baseline during the first two design levels but increased above baseline by the end of the study. BTMs decreased significantly during the first and second level but increased during the third level. Total and L1-L4 BMD, s-phosphate, s-urea, RMR, muscle strength and Peak VO₂ increased significantly while s-calcium and s-magnesium decreased.

Conclusions: Estimated OED of Jarlsberg cheese was 73 and 84 g/day for females and male athletes, respectively. The development in OC, BTMs and BMD suggest an antiresorptive and perhaps anabolic effect of Jarlsberg Cheese on bone tissue. VO₂max, RMR and muscular strength development indicated an anabolic situation.

Is it fear or politics? A qualitative exploration of stakeholders’ views on the failed Ebola vaccine trial in Southern Ghana

Samuel Tamti Chatio — 2024-04-24

Background: The negative meaning and rumours associated with the conduct of clinical trials regarding their experimental nature adversely affect trust and their conduct. A typical example of the challenges in conducting clinical trial studies was where Ghana was selected to conduct the ebola vaccine trials, which was not successful. This study explored the social and political perspectives on the unsuccessful implementation of the ebola vaccine trial in Ghana.

Methods: This was a cross-sectional exploratory study using qualitative research approach where 31 in-depth individual interviews and Key informant interviews were conducted with participants. The interviews were recorded, transcribed and coded into themes using Nvivo 12 software to aid thematic content analysis.

Results: The views expressed by participants suggested that lack of stakeholder engagement to create awareness on the Ebola vaccine trial led to doubts on the purpose for the trial. Also, media propaganda, negative influence and the perception that conducting the vaccine trial in Ghana could introduce the Ebola virus into the country created panic and fear, which affected public trust and support for the Ebola vaccine trial conduct in Ghana. Furthermore, political influence linked with site selection and timing for the study in particular, led to mistrust and the subsequent suspension of the trial in Ghana.

Conclusions: Based on the interpretation of our data, we conclude that the indefinite suspension of the Ebola vaccine trial in Ghana could largely be attributed to both fear and political influence as well as misinformation resulting from media propaganda leading to mistrust.

Anti-ageing effects of CollabZen™ in healthy human volunteers: a randomized, double blind, placebo-controlled study

Mihir C. Gadani — 2024-02-05

Background: There are several concerns related to combating signs of ageing. Considering the long-term safety concerns of cosmetic formulations, a safe and effective approach using nutritional supplements and naturals should be of great help. CollabZen^TM is one such a blend of three plant materials known as Phyllanthus emblica, Camellia sinensis, and Coffea arabica, earlier tested for collagen building in human cells in-vitro. The current study aims to explore its potential as a nutraceutical product for skin ageing.

Methods: The study enrolled 64 volunteers both genders (mean age=45.75) with crow's feet wrinkles. One group (n=32) received a placebo capsule (Product A) and other group received CollabZen^TM capsules (Product B). Dermatological parameters were assessed at 0^th day, 4^th and 8^th week, and self-assessment questionnaires for efficacy and tolerance were collected on 4^th and 8^th week. The trial is registered at https://ctri.nic.in/, CTRI/2022/10/046168.

Results: The results showed that product B (CollabZen^TM) was significantly effective than the placebo in improving deep skin hydration on the face (p=0.009), increasing facial skin elasticity (p=0.001), and enhancing firmness (p=0.001) after 8 weeks. Participants in Group B reported higher levels of satisfaction regarding their perceived skin health compared to group A based on self-assessment at the 8^th weeks (p<0.01). Moreover, only one volunteer in each group experienced mild intolerance at the end of 8th week, demonstrating the safety of these nutraceutical ingredients and excipients.

Conclusions: CollabZen^TM, with its known antioxidant and collagen-boosting properties and current findings can be considered a valuable nutraceutical product for the anti-ageing sector of the cosmetic industry.

Effectiveness of catheter-associated urinary tract infections bundle approach to reduce urinary catheter associated infection rate among children admitted in Paediatric unit

Anju Shukla — 2024-04-24

Background: CAUTI bundle care aims to reduce catheter associated urinary tract infection, enhance quality of life and promote comfort. The present study aimed to assess the effect of CAUTI bundle approach on urinary catheter associated infection rate among children admitted in paediatric unit of KGMU.

Methods: Quantitative research approach was done on 46 children who were admitted in paediatric unit, KGMU, Lucknow. Purposive sampling technique was used. Socio demographic was obtained by socio demographic Performa, CAUTI was assessed by urine culture test and symptomatic assessment of UTI.

Results: The result revealed that on the basis of urine culture results, in exposed group majority of the children that is 18 (78.26%) was sterile and rest 5 (21.73%) was infected and in unexposed group 13 (56.52%) children was sterile and remain 10 (43.47%) was infected. And on the basis of symptomatic assessment for CAUTI, in exposed group majority of the children that is 17 (73.91%) are less symptomatic and remain 6 (26.08%) was more symptomatic for CAUTI and in unexposed group most of the children that is 14 (60.86%) was less symptomatic for CAUTI and rest 9 (39.13%) was more symptomatic for CAUTI.

Conclusions: CAUTI bundles approach provides evidence-based prevention practices and strategies to reduce CAUTI. The present study found that CAUTI bundle care was effective in reducing CAUTI in children.

A prospective, randomized double-blind, placebo-controlled study for safety and efficacy of SesZen-Bio™: a proprietary Sesbania grandiflora extract in managing hair and scalp health in healthy adults

Ratna Upadhyay — 2024-04-06

Background: Hair loss, a common multifactorial condition affecting both genders, results from causes like extrinsic factors (pollution, sun, humidity, and temperature), nutritional variation, or intrinsic factors such as ageing, heredity, hormonal and medical conditions. Some of the damages caused by these factors can be effectively managed with multivitamins, minerals, antioxidant natural products. Present study assessed use of standardised herbal Sesbania grandiflora extract for improving hair density, hair thickness and scalp health along with a serum biomarker to establish the probable mechanism of action.

Methods: The study was approved by the ethics committee and was conducted as per standard national regulations. 51 randomized subjects (mean age: 39.40±5.80 years) received either test-treatment or placebo for consecutive 56 days. Instrumental assessments included a phototrichogram to assess hair density, thickness, and scalp condition.

Results: SesZen-Bio^TM which is derived from Sesbania grandiflora extracts showed an improvement in hair density, hair thickness and ferritin in 8 weeks of usage suggesting it stimulates the keratin production which resulted in improved follicle growth. By day 56 of usage, hair density and thickness improved by 58.92±28.69 cm² and 3.68±2.69 μm respectively from baseline (both p<0.0001) in the treatment group. This indicates towards 25% improvement in hair density, 16.94% in hair thickness and almost 72% volunteers indicated an improvement in hair health along with 27% increase in serum ferritin.

Conclusions: Sesbania grandiflora extract -SesZen-Bio^® showed beneficial nutritional effects on research subjects, proving its usefulness as a well-tolerated and efficient daily supplement to improve hair health.

Exploring the cessation efficacy and harm reduction potential of heated tobacco and nicotine pouch products in smokers and smokeless tobacco users: study protocol of a 6-month randomized controlled switching trial

Nikola Pluym — 2024-04-24

Background: Despite decades of research on pharmacological and behavioural smoking cessation treatments, current quit aids are of limited success. The introduction of new, combustion-free nicotine and tobacco products extended the tool kit for people who smoke to switch away from their risky habit. We performed a systematic review including 120 studies resulting in several recommendations for a robust study design to determine the cessation efficacy of a new nicotine or tobacco product. Consequently, we prepared this study protocol to assess the cessation efficacy of heated tobacco products (HTPs) and nicotine pouches (NPs).

Methods: 250 subjects (125 exclusive smokers and 125 exclusive smokeless tobacco (SLT) users) will be recruited and offered a choice of HTPs in case of smokers and a choice of NPs in case of SLT users in order to switch. Subjects will undergo four visits (baseline, 1, 3, and 6 months) to collect biospecimens and for physical examinations. Use behaviour and questionnaires will be monitored on a regular basis by means of a smartphone-app. We describe a sensitive and specific compliance monitoring using suitable biomarkers of exposure. The sample size of 250 subjects and duration of 6 months will allow the quit rates to be assessed with sufficient statistical power. Finally, the choice between different products shall reflect the individuals’ preferences.

Conclusions: This protocol can be applied generically, providing a robust determination of a products’ cessation efficacy.

Trial Registration: The trial will be registered in the International Clinical Trials Registry Platform.

Diagnostic accuracy of pocket-size lung ultrasound for etiological definition of pneumonia and surveillance of complications in children hospitalized: a prospective diagnostic cohort study

Sara Monteiro — 2024-04-24

Background: Pneumonia, the leading infectious cause of death in children worldwide, often requires a chest radiograph (CXR) for diagnosis, involving radiation exposure. Point-of-Care Ultrasound (POCUS) offers a radiation-free alternative and, specifically the pocket-size variant, enhances convenience at the patient's bedside. While evidence supports ultrasound's accuracy in detecting community-acquired pneumonia (CAP) in children comparable to CXR, few studies have explored its ability to distinguish pneumonia etiology, especially utilizing pocket-size POCUS devices.

Methods: In this prospective diagnostic cohort study conducted over a year in a tertiary pediatric referral center, we aim to assess the diagnostic accuracy of a pocket-size POCUS device compared to CXR for determining the etiology of CAP in pediatric patients (aged >6 months and <18 years). At least 76 participants diagnosed with CAP will undergo independent POCUS examinations at various intervals, complemented by CXRs when necessary, independently classified by a third investigator. The General Electrics Vscan AirTM®, featuring Bluetooth connectivity to smartphone/tablet, will be employed for POCUS. Data collection will include systematized POCUS and CXR descriptions, alongside sociodemographic, clinical, and therapeutic variables. Statistical analysis using SPSS® version 28 will evaluate the diagnostic accuracy of the POCUS device.

Conclusions: This trial's outcomes hold significant promise in unveiling unknown data about the diagnostic accuracy of pocket-size POCUS for pediatric CAP etiological diagnosis. Utilizing a device meeting technical recommendations, featuring a dual-headed probe and Bluetooth connectivity, this study has the potential to bring innovation to clinical practice, improving patient care and creating scientific value.

Trial Registration Number: NCT06296693.

Comparison of the effects of two concentrations of adrenaline (0.33 mg/l versus 1 mg/l) in the irrigation serum for arthroscopic shoulder surgery: protocol of a randomized controlled trial

Edouard Harly — 2024-04-24

Background: Controlling bleeding during arthroscopic shoulder surgery helps improve the clarity of the arthroscopic visual field. Adrenaline is considered an effective and safe method to reduce bleeding. Two doses of adrenaline (0.33 mg/l and 1 mg/l) have been evaluated in the literature, but never against each other.

Methods: This prospective, double-blind, randomized controlled trial will study the clarity of the visual field using a numerical scale (NS) during rotator cuff surgery on 180 patients across 5 centres. The secondary objectives include: the duration of the operation, volume of saline used, increase in baseline pressure, number of arthropump hyperpressures, mean systolic blood pressure and heart rate, as well as sudden variability.

Results: Among the 154 patients in the Clinical Trial Group, 70/154 (45%) continued to have proteinuria, while 84/154 (55%) had no proteinuria (remission) compared to 41 (28%) in remission and 104 (72%) with continued proteinuria in the Usual Care group (p<0.001).

Conclusions: This study aims to determine which of the two dosages previously studied in the literature (0.33 mg/l versus 1 mg/l) provides better clarity.

Trial Registration Number: 2021-A02773-38.

Effects of home-based remote rehabilitation on children and adolescents with cystic fibrosis and non-cystic fibrosis bronchiectasis: a systematic review protocol

Aspasia Mavronasou — 2024-03-01

Background: Home-based remote rehabilitation combining the use of new technological tools is an alternative way of rehabilitation when traditional center-based programs are limited or are not feasible. This systematic review aims to investigate the level of evidence for the effects of home-based remote rehabilitation on children and adolescents with cystic fibrosis (CF) and non-cystic fibrosis bronchiectasis (NCFB).

Methods: This systematic review will follow the preferred reporting items for systematic reviews and meta-analysis (PRISMA). Five databases will be searched from the period of the inception until March 2024: PubMed, Web of Science, Medline (via EBSCOhost), ACM Digital Library, and Scopus. Methodological quality will be assessed using the revised Cochrane Risk of Bias tool for randomized trials (RoB 2) and the risk of bias in non-randomized studies – of interventions (ROBINS-1) tool. The overall quality of the evidence will be assessed using the grading of recommendations assessment, development, and evaluation (GRADE) approach.

Conclusions: Evaluation of the level of evidence for the effects of home-based remote rehabilitation in children and adolescents with CF and NCFB is an important step in the context of telehealth, providing an alternative way of approaching pediatric patients, during the process of rehabilitation.

Trial registration: PROSPERO registration number is CRD42024498403.