cyrilzakka/clinical-trials huggingface dataset:
Iron Absorption From Infant Formula and Iron Drops in Infants (MJAU-studien)

Iron deficiency (ID) affects up to 25% of Swedish infants and severe ID is associated with cognitive and behavioral problems. To avoid this, iron supplements or iron-fortified infant foods are recommended for infants. However, the optimal iron dose and mode of delivery have not yet been established. This is a concern as excessive iron intake may impair growth and increase morbidity in iron-sufficient infants. Previous studies have suggested that iron-fortified foods may have different effects than iron supplements. In this study, the investigators will investigate whether the mode of iron administration (supplementation vs. fortification) and the amount consumed (high intakes vs. low intakes) affect iron absorption, iron utilization, and zinc absorption in healthy term non-iron-deficient 6-month-old infants.


Eligibility Criteria:
Inclusion Criteria:

* 6-7 months of age at the start of intervention
* healthy at enrollment
* full-term (\>37 gestational weeks at birth)
* birth weight \>2500 g
* predominantly bottle-fed at recruitment

Exclusion Criteria:

* iron deficiency at enrollment
* previous or current use of iron supplements
Non-invasive Measurement of Neonatal Central and Peripheral Hemodynamics

Non-invasively neonatal cardiac output can be measured by multiple methods, but the gold standard still remains conventional echocardiography. It is accurate, but needs a long training for new users to assess cardiac function. Continuous-wave Doppler ultrasound monitor USCOM is a relatively new monitor which can perform faster and less complex cardiac function measurement, also it is easier for the operator to get trained. The aim of the study is to assess the level of agreement between cardiac output measured with conventional echocardiography and with USCOM, to present normal ranges for neonates of different gestational age and to look for early signs of hemodynamic changes during sepsis.


Eligibility Criteria:
Inclusion Criteria:

* newborns of any gestational age
* parental consent acquired

Exclusion Criteria:

* congenital malformations
* hemodynamic instability in control group
* any respiratory support in control group
* infection in control group
DRIVE - Perioperative Period

This study will investigate if the HbA1c result before surgery which assesses glucose control over the longer term, can accurately predict what happens to the glucose levels and glucose profile following surgery. This will be recorded using continuous glucose monitoring sensors which are worn by participants pre and post elective surgery.

The research question addressed in this study is how preoperative markers of diabetes control correspond with the fluctuations in glucose levels which occur around surgery measured using continuous glucose monitoring (CGM). At present a HbA1c blood test prior to surgery is routinely used to infer the surgical risk associated with a person's glucose levels. HbA1c gives a measure of average blood glucose levels over the preceding 2-3 months and the joint British diabetes society guidelines recommend aiming for an HbA1c of 69mmol/mol or less before planned surgery.

However the HbA1c does not give a complete picture of a person's diabetes control and the evidence behind this threshold is incomplete. Furthermore due to the physiological stress of surgery and counterregulatory hormone release glucose levels can be more dynamic and unpredictable in this population. With CGM glucose levels are recorded multiple times an hour, revealing glucose variation and the amount of time the person's glucose levels spend above and below the ideal range which is understood to be associated with increased risks. This study aims to examine how such glucose patterns and 'at risk' time periods when glucose levels are outside of the target range correspond with different levels of HbA1c before surgery. This is an important area of study as diabetes is becoming increasingly prevalent in surgical patients and is associated with worse outcomes. Using new technologies to evaluate predictors of such harmful patterns in glucose levels is therefore vital.

Individuals who are eligible for this study are those with type 2 diabetes undergoing elective primary hip or knee replacement surgery. This is an observational study. Participants will wear a Freestyle Libre Pro glucose sensor for 2 weeks before and 2 weeks immediately post their surgery. The investigators will also collect information about participants recovery.

Duration of the study will be up to 8 weeks. The study will take place at Portsmouth Hospital NHS trust.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes (on diet, oral, injectable and / or insulin therapy for diabetes)
* Be scheduled for primary elective hip or knee replacement surgery at Queen Alexandra Hospital
* Willing and able to give informed consent for participation in the study

Exclusion Criteria:

* Enrolled in another study that may affect glycaemic control over the 4-6 week period of active data collection with the sensor
* Taking oral steroids for longer than 2 weeks that incorporates the 4-6 week period of active data collection with the sensor
* Currently pregnant or planning pregnancy
* On dialysis
* Taking antipsychotic medication
* Non primary surgery (including emergency or revision surgery)
Relationship Between Mouth Opening and Masseter Elasticity in Oral Cancer

The study aims to assess the hardness of masticatory muscles in post-surgical oral cancer patients using strain elastography ultrasound, calculating the masseter elasticity index and exploring its association with maximum interincisal mouth opening. Furthermore, the study incorporates exercise training to analyze whether changes in masseter hardness can serve as an objective indicator for predicting the improvement of trismus.

This study aims to evaluate the hardness of masticatory muscles in patients who have undergone surgery for oral cancer, using strain elastography ultrasound. Specifically, the research focuses on measuring the elasticity of the masseter muscle by calculating the masseter elasticity index (MEI) and analyzing its correlation with maximum interincisal mouth opening (MIO). Since trismus, or restricted mouth opening, is a common post-surgical complication affecting oral function and quality of life, understanding the relationship between muscle elasticity and jaw mobility is crucial. Additionally, the study incorporates a structured exercise training program designed to improve jaw function in these patients. By monitoring changes in masseter muscle hardness before and after the intervention, the research aims to determine whether variations in muscle elasticity can serve as an objective indicator for predicting improvements in trismus.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed oral cancer patients who are scheduled to receive cancer-related treatments (e.g., oral cancer surgery, radiotherapy, chemotherapy, or chemoradiotherapy).
2. Age between 20 and 65 years.

Exclusion Criteria:

1. Could not communicate.
2. Had any disorder that could influence movement performance.
Self-management Intervention to Improve Adolescents' Asthma Control

Approximately 1.1 million children and young people in the United Kingdom (UK) are living with asthma, making it the most common chronic disease in children in the UK. Our recent observational study found that poor asthma control, poor medication adherence, and a poor understanding of asthma were key unmet needs of secondary school children. Following the findings from an earlier study, the investigators have developed a preliminary theory-based multi-faceted intervention, aimed at improving asthma self-management and control in young people.

The investigators have developed a theory-driven self-management intervention for children and young people which addresses the barriers to successful self-management, which were identified in an earlier study. The intervention will engage asthmatic teenagers and their peers, and will be delivered in two components. The first component includes a theatre workshop for all children aged 11-13 years in London secondary schools. The aim of this component is to raise awareness of asthma in schools among peers. The second component is a series of four self-management workshops for children with asthma. The aim of this component is to teach children about asthma, using interactive role plays and games. The main topics will include asthma general knowledge and understanding; General Practitioner (GP) communication; asthma triggers and symptoms; medication and emergency response; and self-management techniques and goal setting. The children will also receive a toolkit to take home with them, which will include a copy of the workbook that they have used during the day, containing information on what they have learnt. There will also be information on where they can get more help for their asthma. The toolkit will also include information about a smartphone gaming app, which will be about asthma knowledge.

Eligibility Criteria:
Inclusion Criteria:

* Doctor-diagnosed asthma
* Aged 11-14 years (UK school years 7-8)
* Attending the secondary school in which the study is implemented
* All children in years 7 and 8 in UK secondary schools are eligible to watch the theatre performance

Exclusion Criteria:

* No diagnosis of asthma
* Not aged 11-14 years (UK school years 7-8)
* Not attending the school at the time the intervention is delivered
Postoperative Vocal Cord Palsy Between Double-lumen Endobronchial Tube and Bronchial Blocker for Robot-assisted Esophagectomy

The goal of this clinical trial is to investigate whether the use of bronchial blocker could reduce the incidence of postoperative vocal cord palsy than the use of double-lumen endobronchial tube in robot-assisted esophagectomy.

Esophagectomy is a challenging surgery that usually requires one lung ventilation, and double-lumen endobronchial tubes and bronchial blockers are commonly used for one lung ventilation.

Successful resection of recurrent laryngeal nerve lymph nodes during esophagectomy is important to survival and prevention of cancer recurrence, but there is a risk of postoperative vocal cord palsy due to the recurrent laryngeal nerve injury during the resection.

Compared to a double-lumen endobronchial tube, the use of a bronchial blocker is expected to reduce the incidence of recurrent laryngeal nerve injury; however, few clinical studies compare the two devices in terms of the incidence of postoperative vocal cord palsy in robot-assisted esophagectomy.

Therefore, the researchers aimed to investigate whether the use of bronchial blocker could reduce the incidence of postoperative vocal cord palsy than the use of double-lumen endobronchial tube in robot-assisted esophagectomy.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 19 or older
* American Society of Anesthesiologists physical status I - III
* Elective robot-assisted esophagectomy
* Any clinical stage of esophageal cancer
* Patients who need recurrent laryngeal nerve lymph nodes resection

Exclusion Criteria:

* Patients who diagnosed vocal cord palsy or damage before surgery
* Patients who need specific airway device due to airway problem
* History of thoracic surgery
* Emergency surgery
* Combined surgery with other department
* Pregnant or nursing women
Risk Factors for Thromboembolic and Infectious Complications Related to Percutaneous Central Venous Catheters in Cancer - Prospective Multicenter Study

The purpose of this study is to identify risk factors for thromboembolic and /or infectious complications in 3,000 patients with solid tumor and receiving a Percutaneous Central Venous Catheter (PCVC). A better understanding of the risk factors for these complications in this population would then allow interventional studies to be proposed to assess the benefit of prophylactic procedures in a sub-group of patients at most risk.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a neoplastic solid tumour with an indication for insertion of a PCVC.

Exclusion Criteria:

* Haematological neoplasm pathology, PCVC removal scheduled within 2 weeks of insertion,
* Therapeutic doses of anticoagulants required at inclusion,
* PCVC inserted by the femoral vein
Pharmacokinetics of Voxilaprevir in Adults With Normal Renal Function and Severe Renal Impairment

The primary objective of this study is to evaluate the pharmacokinetics, safety, and tolerability of voxilaprevir (formerly GS-9857) in participants with severe renal impairment and matched healthy control participants.


Eligibility Criteria:
Key Inclusion Criteria:

* All individuals:

  * Screening laboratory values within defined thresholds for group
  * Use of two effective contraception methods if female of childbearing potential or sexually active male
* For individuals with severe renal impairment:

  * Stable chronic kidney disease
  * Creatinine clearance (CLcr) \< 30 mL/min

Key Exclusion Criteria:

* All individuals:

  * Pregnant or nursing female or male with pregnant female partner
  * Hepatitis B virus, hepatitis C virus (HCV) or HIV infection
  * History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol
* For individuals with severe renal impairment:

  * Anticipated to require dialysis within 90 days of study dosing

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Heated Pool Exercise Groups for Patients With Rheumatic Diseases

The purpose of this study is to investigate the effects of heated pool group exercises for patients with inflammatory rheumatic diseases with regard to symptoms (pain, fatigue, stiffness and ability to carry out daily activities).

The patients receive text messages on mobile phones twice a week for circa 40 weeks. The text messages ask for pain, fatigue, stiffness and ability to carry out everyday activities. The patients should respond with a number from 0 to 10, where 0 is no symptoms/no hindering of activity and 10 is worst symptoms/worst hindering of activity.

Eligibility Criteria:
Inclusion Criteria:

* Referral from a medical doctor to group exercises in heated pool
* Inflammatory rheumatic joint disease
* \> 18 years
* Stable disease
* Mobile phone owner
* Understand and use text messages on mobile phones

Exclusion Criteria:

* Independent living
* Joint surgery previous to the study start
Investigating the Glycaemic and Satiating Capacity of PulseOn® Enriched Foods

The purpose of this randomised control trial is to determine whether consuming PulseOn enriched crackers for breakfast influences post-prandial glycaemic response and markers of appetite (hunger, fullness, desire to eat) over 4 hours, and energy intake at an ad libitum lunch meal on the same day. Healthy individuals with no underlying metabolic disease will be recruited to take part in this study.

PulseON® is a unique flour that is made 100% from pulses, but unlike other flours it has been obtained through an alternative milling process (WO2019155190) which preserves whole plant cells (Edwards et al., 2020). These cells were shown to remain intact during down-stream processing into food products including bread and biscuits, and influence glycaemic response to these foods (Delamare et al., 2020; Bajka et al., 2021). Interestingly, the PulseON®-enriched breads also significantly enhanced and prolonged release of the gut hormones glucagon-like peptide-1 (GLP1) and peptide YY (PYY), which are known to have anorexigenic effects (Bajka et al., 2023). Studies using chick pea purees and hummus products have also shown positive findings in relation to appetite sensations and food intake (Pälchen et al., 2022; Alshaalan et al., 2024).

This work aims to recruit 50 participants through the use of posters and emails at Sheffield Hallam University, as well as in the local Sheffield area and through social media.

-30 minutes - baseline measures (body mass index (kg/m2), waist circumference (cm), blood glucose (mmol/l), hunger, fullness, desire to eat) are taken

0 minutes - pre-load consumed within 15 minutes (75g wheat flour / PulseOn crackers) The wheat flour cracker is made from 100% wheat flour. The PulseOn cracker is made from 40% PulseOn flour and 60% wheat flour.

30, 45, 60, 75, 90, 105, 120, 150, 180, 210 minutes - repeat baseline measures

240 minutes - ad libitum lunch provided (pasta and tomato sauce) and participants instructed to eat to fullness.

Paired sample t-tests will be used to compare measures between the two visits.

Eligibility Criteria:
Inclusion Criteria:

* over the age of 18y

Exclusion Criteria:

* smoker / recreational drug user
* restrained eater (as determined by the three factor eating questionnaire (TFEQ-R18))
* vegan
* pregnant / lactating
* blood clotting disorder
* taking medication for heart / metabolic disease
* pacemaker fitted
* energy restricted diet or lost \>5% body weight in the last 3 months
* elite athletes
* dysphagia
* food allergy / intolerance
* disease / inflammation of the GI tract
Efficacy of TPACK-Based Instruction in an Information Resources Course for Nursing Students

Study Purpose The purpose of this study is to evaluate the effectiveness of a blended teaching approach based on the TPACK framework in improving the skills of master\&#39;s degree nursing students in retrieving and using network information resources. The TPACK framework integrates Technology, Pedagogy, and Content Knowledge to enhance teaching and learning experiences.

Study Content and Implementation Plan

This study involves a combination of online and offline teaching methods to help nursing students better understand and utilize various information resources. The main components of the study include:

1. Knowledge Mastery Survey: Students will be assessed on their understanding of the course content using a specially designed survey.
2. Resource Effectiveness Evaluation: The study will measure how helpful students find the different resources used in the course, such as videos, PPTs, and assignments.
3. Skill Improvement Assessment: The study will evaluate the extent to which the course helps improve students\&#39; abilities in areas like literature search, document management, and academic writing.
4. Student Satisfaction Survey: Students will provide feedback on their satisfaction with the course through a comprehensive survey.

By implementing these measures, the study aims to minimize any negative effects on students and maximize their learning outcomes in a safe and supportive environment.

This study evaluates the effectiveness of a TPACK (Technological Pedagogical Content Knowledge) framework-based instructional approach in a course on Network Information Resources Retrieval and Usage among master's degree nursing students. The research employs a quasi-experimental design to compare the outcomes of an intervention group, which receives TPACK-based blended learning, with a control group that experiences traditional face-to-face instruction.

This study aims to provide evidence on the efficacy of the TPACK-based blended learning approach in enhancing educational outcomes in nursing education.

Eligibility Criteria:
Inclusion Criteria:

* Master's degree students enrolled in the nursing program at the participating university.
* Students who have completed the prerequisite courses relevant to the Network Information Resources Retrieval and Usage course.
* Students who have provided written informed consent to participate in the study.
* Students with regular access to the internet and necessary technological devices for participating in online components of the course.

Exclusion Criteria:

* Students who have previously completed a similar course or have extensive prior experience with network information resources retrieval and usage.
* Students who are unable to commit to the course schedule and requirements due to personal or professional reasons.
* Students with known learning disabilities or conditions that might interfere with their ability to complete the course assessments, unless they receive appropriate accommodations.
* Students who withdraw consent at any point during the study.
Opioid Package Prototype (OPP)

The overall objective of this clinical trial is to identify the impact of selected package features, known as the Opioid Package Prototype (OPP), on the safe and effective use of opioids. Our specific aims are: (Aim 1) to evaluate the effectiveness of OPP on prescribing, dispensing, and patient use of oxycodone among orthopaedic surgery patients receiving post-operative outpatient oxycodone for post-surgical pain management, and (Aim 2) to determine the feasibility of OPP for orthopaedic surgery prescribers, pharmacists, and orthopaedic surgery patients. Such data can be used to further optimize packaging and labeling design, help patients and caregivers utilize their medication and packaging correctly, and improve prescribing and dispensing habits. The central hypothesis is that the OPP will be more effective than the amber vial in efforts to reduce oxycodone prescribing among patients over 18 receiving short-term management of post orthopedic surgery pain.


Eligibility Criteria:
Inclusion Criteria:

1. The patient is 18 years and older;
2. The patient is one of the participating surgeons;
3. The patient is receiving orthopaedic surgery that involves the use of opioid medication for post-operative pain;
4. The patient is willing to receive oxycodone medication;
5. The patient is willing and able to receive medication at the UConn Health Specialty Pharmacy, located in the Exchange across the street from the main entrance of UConn Health;
6. The patient is willing and able to use a MyChart account;
7. The patient is able to read and understand English; and
8. The patient is able to understand the study procedures and their involvement in the study.

Exclusion Criteria:

-
The Effect of Portable AR on Tooth Brushing Skill for Elementary School Students

The aim of this study An augmented reality (AR) simulation toothbrushing machine was developed to train proper brushing technique for children. The investigators aimed to evaluate the effects of AR brushing machine on knowledge of dental clearing skill, self-efficacy and dental plaque control in elementary schoolchildren in Taiwan.

A quasi-experimental design was conducted; ten intervention schools (AR group) and ten comparison schools were selected from elementary schools. Overall, grade 3-6 students in the AR group (n = 290) and the traditional group (n = 311), respectively. Students in the AR group received a two-time repeated AR-based training for 30 minutes at two-week intervals. Students in the CG received traditional classroom-based teaching. Baseline and follow-ups information was collected using dental plaque examinations and questionnaires. The generalized estimating equations(GEE) were used to evaluate the outcomes between two groups over time.

Eligibility Criteria:
Inclusion Criteria:

* Primary school students 3 to 6 grades

Exclusion Criteria:

* Schoolchildren with disability certification.
* Schoolchildren with congenital severe oral diseases (eg. cleft lip and palate )
* Disability to operate the AR system