cyrilzakka/clinical-trials huggingface dataset:
The Levels of Anaesthetics in Heart Muscle During Heart Surgery

In the last few years, anaesthetic agents, Isoflurane used in heart surgery have shown some benefits to reduce the risk of heart muscle damage. Many research studies have been conducted to reveal the benefit relationship between Isoflurane and the risk of heart muscle injury during heart surgery. However, there is a knowledge gap regarding the optimal level of Isoflurane concentration to confer the benefit of heart muscle-protective properties. Therefore, this study is conducted to answer that question by measuring the Isoflurane concentration in the blood vessels. It also assesses whether Isoflurane concentration in the blood is correlated to the oxygenator exhaust level of Isoflurane in the heart-lung machine.

All patients who scheduled for an elective heart surgery in Royal Infirmary of Edinburgh using a heart-lung machine and the administration of ether-like anaesthetic, isoflurane will be recruited in this study. This is a pilot study to determine the concentration of isoflurane in heart muscle. Isaac and Michael (2005), Hill (1998), Julious (2005) have conducted survey/research to conclude that 30 sample sizes are adequate for a pilot study. Thus, investigators aim to recruit at least 30 sample sizes to allow data (standard deviation, mean etc.) used in sample size estimation for future studies.

The medical and surgical care plans for participants remain as usual in this study. In a normal practise, surgeons will insert a catheter into the blood vessels coming from the heart to deliver solution to stop the contraction of heart for heart procedure. At this moment, two blood samples of about two-teaspoonful in volume will be collected from the in-placed catheters in vein and aorta. Then, the blood samples will be sent to lab to measure the concentration of isoflurane in vein and aorta. Also, the reading of exhausted isoflurane gas on heart-lung machine are routinely monitored and recorded.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Scheduled for elective cardiac surgery requiring cardiopulmonary bypass.
* Anaesthetised using isoflurane as part of a balanced anaesthetic technique during heart-lung machine
* Patient has consented to participate
* Cardioplegia technique involves insertion of a coronary sinus catheter.

Exclusion Criteria:

* Emergency surgery or patient with malignancy
* Heart surgery undertaken without heart-lung machine
* Age younger than 18 years
* Unable or unwilling to provide informed consent
* Cardiac surgery that does not require cardiopulmonary bypass
* Anaesthetised using an total intravenous-based technique
Moms@Home: A Storytelling-based Mobile Health Intervention to Improve Blood Pressure Management in Pregnancy

This pilot study will examine the effects of a digital health approach, Moms@Home, on home blood pressure monitoring in a diverse population of pregnant women with hypertension.

The study aims to standardize and test a storytelling approach to promote HBPM and improve BP management and pregnancy-specific outcomes in pregnant women with Hypertension (HTN). The study will integrate three components to improve BP care and outcomes: 1) the Moms@Home mobile app to promote HBPM through storytelling videos and a patient dashboard of BP data, 2) a digital BP monitor for HBPM, and 3) an HBPM report that curates and shares key health data with the right provider at the right time. Designed by and for pregnant women with HTN across racial/ethnic groups, the Moms@Home intervention is novel because it leverages digital health, behavior change techniques, and culturally relevant storytelling to improve HTN self-care while facilitating patient/caregiver communication through an HBPM report. Investigators are conducting a pilot randomized controlled trial (RCT) of Moms@Home vs. enhanced standard care, with plans to enroll 100 pregnant women (50% from racial/ethnic minority groups) with gestational or chronic HTN to determine whether Moms@Home vs. enhanced standard care (BP monitor, diary) improves HBPM adherence (primary outcome) and to evaluate the feasibility, acceptability, and sustainability of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-50
* English or Spanish speaking
* A diagnosis of gestational (20-26 weeks gestational age) or chronic hypertension (8-26 weeks gestational age)
* Singleton or multiple gestation pregnancy,
* A patient of the University of Massachusetts Memorial Health Obstetrics/Maternal and Fetal Medicine clinics in Worcester, Massachusetts
* Willing to share home blood pressure monitoring data
* Comfortable with the use of smartphones and mobile apps

Exclusion Criteria:

* Severe hypertension (Systolic blood pressure ≥160 mmHg or Diastolic blood pressure ≥100 mmHg)
* Current diagnosis of preeclampsia
* Active substance use
* Serious physical illness (e.g., unable to interact with a smart device)
* Enrolled in another home blood pressure monitoring program
* Excluded from study participation by their provider
* Inability to provide informed consent
* Prisoners/institutionalized individuals
Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder

The goal of this clinical trial is to compare the effect of nutritional counseling versus no treatment in patients with schizophenia or bipolar affective disorder.

The main question it aims to answer are:

• Can nutritional counseling have a preventive effect on the development of cardiovascular disease in patients with schizophenia or bipolar affective disorder?

Participants will meet a nutritionist at baseline to asess nutritional status, biochemical and anthropometric measurements. Then, half of the study population will receive nutritional counseling. After six weeks, the same baseline measurements will be repeated to examine any potential differences between the two groups. After the intervention, the control group will be offered the same counseling as the intervention group received during the study.

People with severe mental illness have a shorter life expectancy compared to the general population. Individuals with schizophrenia or bipolar affective disorder have an estimated reduce life expectancy by an average of 10-20 years. Increased mortality is caused by many factors, but cardiovascular diseases contributes the most. Increased prevalence of cardiovascular disease is mainly due to a poor lifestyle, which includes smoking, physical inactivity and an unhealthy diet.

It is important to find treatment that can provide better quality of life and longer life expectancy in these patient groups. Few clinical studies have been conducted on the effect of nutritional counseling on biochemical and anthropometric measurements related to cardiovascular diseases. Therefore, we want to investigate this through a randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* Diagnosed with either schizophrenia/psychosis or bipolar affective disorder
* Patients treatet in Vestre Viken healthcare company, at either Asker district psychiatric center or Blakstad hospital

Exclusion Criteria:

* none
Robotic Versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT Using Integrated Intraprocedural Imaging

RELIANT 2 is a pragmatic randomized controlled trial. The goal of this study is to compare the diagnostic yield of robotic assisted bronchoscopy with integrated cone beam computed tomography to that of electromagnetic navigation bronchoscopy with integrated digital tomosynthesis in patients undergoing bronchoscopy to biopsy a pulmonary lesion.

Pulmonary nodules are an incredibly common finding, with millions incidentally detected in the US every year. Biopsy is often needed for diagnosis. There are several technologies currently available to biopsy these lesions, including electromagnetic navigational bronchoscopy (ENB) and robotic assisted bronchoscopy (RAB). The latter is used clinically with either conventional fluoroscopy or with cone beam computed tomography (CBCT) guidance, which provides real time 3-dimensional images during the procedure. Recently, CBCT has been integrated with RAB, which allows for automatic update of the lesion location. This update is believed to increase the diagnostic yield of the procedure. Given this new upgrade, we designed this pragmatic, randomized controlled study to test the hypothesis that the diagnostic yield of RAB with integrated CBCT is superior to ENB with integrated digital tomosynthesis in patients undergoing bronchoscopic biopsy of a peripheral pulmonary lesion. Patients undergoing advanced diagnostic bronchoscopy to biopsy a lung lesion will be assigned to either the RAB or ENB based on cluster randomization. Randomization will be revealed each morning before procedures are started. Any advanced diagnostic bronchoscopy scheduled on that day will be performed with the device (RAB or ENB) allocated to that room on that day. All decisions regarding procedure tools, techniques, and patient management will be per usual care and at the discretion of the treating physician.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age at time of bronchoscopy
* Scheduled for navigational bronchoscopy for the evaluation of a pulmonary lesion

Exclusion Criteria:

* Patient declines to participate
* Patients enrolled in another trial which requires the use of one specific navigational platform
Determining the Glycemic Effects of Three Types of Spaghetti

This study investigated the effects of thee types of spaghetti No7 on the glycemic response

This study aimed to 1. determine the glycemic index and glycemic load of thee spaghetti No7 types (regular, whole wheat and high fiber-low carbohydrates) and 2. investigate the effects of these spaghetti types on postprandial glycemic response in healthy subjects

Eligibility Criteria:
Inclusion Criteria:

* healthy
* non-smoking
* non-diabetic men and women
* body mass index between 18 and 25 kg/m2

Exclusion Criteria:

* severe chronic disease (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver conditions, endocrine conditions)
* gastrointestinal disorders
* pregnancy
* lactation
* competitive sports
* alcohol abuse
* drug dependency
Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients

Prospective observational crossover study of 150 consenting adult patients who are undergoing chronic pain management. For insomnia treatment, each patient ingests prescribed doses of Lemborexant or Zopiclone or Clonidine on alternate nights. Each patient uses a special validated sleep diary to collect data including pain score, sleep score, sleep duration, sleep medication type, and adverse effects. Each patient completes the diary for 3 continuous weeks. Pain is measured using the numeric pain rating scale. Sleep score is measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points is considered significant.

Objectives: Chronic pain is usually associated with insomnia. The objective of this clinical study is to compare the safety and efficacy of Lemborexant or Zopiclone or Clonidine; for the management of chronic insomnia in patients with chronic pain.

Methods: Prospective observational crossover study of 150 consenting adult patients who are undergoing chronic pain management. For insomnia treatment, each patient ingests prescribed doses of Lemborexant or Zopiclone or Clonidine on alternate nights. Each patient uses a special validated sleep diary to collect data including pain score, sleep score, sleep duration, sleep medication type, and adverse effects. Each patient completes the diary for 3 continuous weeks. Pain is measured using the numeric pain rating scale. Sleep score is measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points is considered significant. Data analyzed with IBM® SPSS® Statistics 25 (IBM Corp, Armonk, NY); using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value \<0.05 is considered significant.

Eligibility Criteria:
Inclusion Criteria:

* adult chronic pain patients
* good treatment compliance
* severe chronic insomnia
* failure of non-pharmacologic sleep therapy
* regular zopiclone therapy for 3 months or more
* regular sleep diary
* regular pain diary
* informed consent for diary review
* consent for clinical record quality assurance review

Exclusion Criteria:

* obstructive sleep apnoea
* body mass index (BMI) ≥40
* organ insufficiency
* cognitive disorder
* inability to provide consent
* major neuropsychiatric disorder
* unreliable diary
* cannabis use
* regular alcohol intake
* stimulant use
* substance abuse
* poor treatment compliance
* high dose opioid
* gabapentinoid use
* sedative use
* mild insomina
* irregular zopiclone intake
* regular zopiclone therapy for less than 3 months
* previous adverse/allergic reactions to clonidine or zopiclone
Vitamin D Supplementation in Glomerular Disease

This multi-site, pilot study will assess vitamin D supplementation in children and young adults with Glomerular Disease. .

Vitamin D deficiency has been linked to a variety of adverse health outcomes. Nephrotic patients have very low vitamin D levels, and the underlying mechanisms are not known. Furthermore, approaches to safely and effectively supplement vitamin D in these patients have not been established. The purpose of this research study is to learn if vitamin D supplementation is safe and effective in patients with primary glomerular disease and to also help establish the treatment guidelines. About 35 patients with primary glomerular disease, ages 5-30 years old, will take part in this study. Participants will be asked to take vitamin D supplements each day for 12 weeks and will have 3 study visits.

Eligibility Criteria:
Inclusion Criteria:

* Males or females, age 5-30 years
* Diagnosis of primary glomerular disease (such as steroid-resistant nephrotic syndrome, minimal change disease, FSGS, membranous nephropathy, membranoprolfierative glomerulonephritis, and Immunoglobulin A \[IgA\] nephropathy) without systemic inflammatory disorders (i.e. lupus, vasculitis)
* Serum 25(OH)D level \<30 ng/ml and urine protein:creatinine ratio ≥0.5 at Screening Visit.

Exclusion Criteria:

* Pregnancy
* estimated Glomerular Filtration Rate (eGFR) \<30 ml/min/1.73m2 at Screening Visit
* Serum phosphorus \> 5.5 mg/dl or hypercalcemia
* Chronic medical conditions or medications unrelated to the renal disease that may impact vitamin D status
* Known history of kidney stone(s)
Effect of Music on Coronary Angiography

This study was conducted in a randomized, controlled experimental design to examine the effect of music on comfort, anxiety and hemodynamic parameters during coronary angiography. The research was conducted with 78 patients (39 intervention and 39 control groups) who were processed in the Coronary Angiography Laboratory of Necmettin Erbakan Training and Research Hospital between February and June 2024. The intervention group listened to nature sounds based music during the angiography procedure, but no intervention was made to the control group. "Introductory Information Form," "State Anxiety Scale," "General Comfort Scale," and "Hemodynamic Parameters Record Form" were used to collect the data.


Eligibility Criteria:
Inclusion Criteria:

* Being 18 years of age or older
* Being at least literate
* Having no mental and cognitive competence
* Understanding and speaking Turkish
* Having a planned coronary angiography
* Performing for diagnostic purposes

Exclusion Criteria:

* Having visual and hearing impairment
* Having a psychiatric diagnosis
* Using psychiatric medication (tranquilizers, etc.)
* Using anxiety medication in the last 6 months
* Having had coronary angiography before
* The coronary angiography procedure is being performed for therapeutic purposes (stent, balloon, etc.)
* An unexpected complication during coronary angiography (arrhythmia, MI, bleeding, etc.)
* coronary angiographyprocedure started for diagnostic purposes and stent and/or balloon procedures were applied during the procedure
* Data collection forms were not filled out by the participant after coronary angiography
Upper Limb Robot-Assisted Therapy in Patients with Guillain-Barré Syndrome

Guillain-Barré Syndrome is an immune-mediated polyradiculoneuropathy, with around 100,000 new cases reported worldwide annually.

The aim of this double-blind randomized controlled trial with a SHAM control group is to evaluate the effects of robot-assisted therapy, integrated with conventional therapy, on upper limb motor recovery in patients with GBS.

Guillain-Barré Syndrome is a leading cause of acute flaccid paralysis, presenting with limb weakness and hyporeflexia or areflexia. Guillain-Barré Syndrome is an immune-mediated polyradiculoneuropathy, with around 100,000 new cases reported worldwide annually. This study aims to assess the effectiveness of a robot-assisted rehabilitation treatment for upper limb motor recovery in patients with Guillain-Barré Syndrome. A double-blind randomized trial will be conducted, where the experimental group will undergo actual robotic rehabilitation sessions, while the control group will perform sessions in which the robot will carry out simple mobilization, comparable to traditional interventions. This approach will help maintain participant blinding. Patients will be evaluated before and after treatment, and with two follow-up assessments 60 and 90 days after therapy initiation. Evaluations will include muscle recruitment and autonomy in daily living activities.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Guillan-Barré Syndrome;
2. UL motor impairment (0-4 in the Medical Research Council scale);
3. sub-acute phase (until 180 days);
4. Patients able to maintain the sitting position.

Exclusion Criteria:

1. Concomitant neurological, orthopedic, metabolic, and oncological diseases;
2. Cognitive impairment assessed with the Mini Mental State Examination (score under 24 points);
3. Visual deficit;
4. Hearing disorders.
Testing the Veggie Brek Intervention

This programme of work aims to investigate the feasibility and acceptability to both children and nursery staff of offering vegetables to children at breakfast time at nursery. Research will be completed to assess the feasibility of undertaking a subsequent cluster randomised controlled trial (RCT) on this question.

Children are not eating a sufficient amount of fruit and vegetables to ensure optimal health and development. Interventions are needed to help increase fruit and vegetable intake from the early years of children's lives, to support the development of lifelong healthy eating habits and the acceptance of vegetables as an important element of a normal diet. Vegetables are often refused by young children due to their often-bitter tastes, and so efforts to increase children's intake of vegetables is a health priority. Vegetables are not commonly offered at breakfast time, which reduces the opportunities each day for vegetables to be part of children's routine diets. Therefore, it is important to understand whether children will be willing to eat - or at least try - vegetables when offered alongside a usual breakfast food (e.g., cereal or toast). Preschool children eat many meals in childcare settings therefore nurseries provide an ideal setting in which to test whether the addition of vegetables at breakfast is feasible and acceptable to both children and nursery staff. This research will recruit nurseries in the East Midlands, UK, to investigate whether children and nursery staff are willing and able to offer (and eat) vegetables at breakfast. The study will adopt a feasibility cluster randomised controlled trial design where nurseries will be randomly allocated to deliver the Veggie Brek intervention or usual breakfast every weekday for three weeks. There will be a baseline period and follow-up period of five days where vegetables will be offered to children at breakfast.

Data will also be collected to understand the nursery staff's views on the study and how easy/difficult the study's procedures were to implement (e.g., were instructions clear and could be followed, were there any barriers to offering vegetables at breakfast). This information will be used to inform the feasibility and acceptability of a later trial.

Eligibility Criteria:
Inclusion Criteria:

* Located in the East Midlands and surrounding areas.

Children:

* Aged 18 months - 4 years.
* Weaned onto solid foods and able to self-feed.
* Eat breakfast at their nursery at least one day a week.

Exclusion Criteria:

* Children with any allergies or intolerances to raw carrot or raw cucumber, or with any conditions which impact feeding or eating in relation to this study (i.e., the offering of raw carrots and cucumber to children in a nursery setting) are not able to take part.
A Clinical Pathway for Nursing Home Acquired Pneumonia

Nursing home residents are frequently transferred to hospital for management of pneumonia. This often leads to hospital related complications and is a burden on the acute care health system. The purpose of this study is to assess whether managing residents with pneumonia and lower respiratory tract infection on site in the nursing home can reduce hospital admissions and can reduce complications and improve quality of life for residents. We have randomized residents with nursing home acquired pneumonia to on-site management, using a clinical pathway, versus usual care.

We conducted a cluster-randomized controlled trial where nursing homes were randomized to either use of a clinical pathway or usual care for management of nursing home acquired pneumonia. The clinical pathway included chest radiographs performed on-site in the nursing home by a mobile x-ray unit, use of hypodermocylysis (subcutaneous infusion) for re-hydration, administration of an oral antimicrobials, and use of pulse oximetry to assess oxygenation. The main outcomes were hospital admission rate and length of stay. Secondary outcomes included health related quality of life, rates of both infectious and non-infectious complications within four weeks of onset of symptoms; mortality rate of residents with pneumonia (death from all causes within 30 days of onset of symptoms. Time to stabilization of vital signs, as well as functional status at four weeks, were assessed.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms or signs of lower respiratory tract infection as defined by standardized criteria.

Exclusion Criteria:

* Residents were excluded if they were not expected to live longer than 30 days from the date of enrollment, had a previous anaphylactic or serious allergic reaction to quinolones, had advanced directives that they are not be transferred to hospital for treatment.