cyrilzakka/clinical-trials huggingface dataset:
Optimising a Digital Diagnostic Pathway for Heart Failure in the Community

This is a prospective, observational study. The primary aim is to assess the diagnostic accuracy of Artificial Intelligence (AI) analysis of Point of Care (POC) handheld transthoracic echocardiogram images (POC handheld echocardiogram) compared to the current gold-standard of transthoracic echocardiogram images acquired and analysed by a British Society of Echocardiography (BSE) accredited operator, using a standard echocardiogram machine (standard TTE), for the diagnosis of Heart Failure with reduced Ejection Fraction (HFrEF), in patients referred from the community for investigation of suspected new Heart Failure (HF).

1. Demonstrate that in comparison to using the current gold standard of BSE accredited operator echocardiography within a HFDP, using AI enhanced analysis of POC handheld echocardiography is accurate and safe. This has the potential to improve access to timelier echocardiography in order to achieve earlier HF diagnosis and treatment, which is known to delay/prevent progression to HF hospitalisation. It will also provide useful information regarding the future feasibility of using AI enhanced analysis of POC handheld echocardiography in the community, for investigation of people with suspected new HF.
2. Facilitate the digitisation of an NHS Heart Failure diagnostic service in order to standardise and improve the quality of data collection and clinical care provided within the service.

Eligibility Criteria:
Inclusion Criteria:

* Adult individuals referred from the community who are awaiting HF diagnostic investigations, including echocardiography, to investigate for a suspected new diagnosis of HF

Exclusion Criteria:

1. Individuals less than 18 years of age
2. Individuals who have had an interim echocardiogram for another clinical reason, whilst on the outpatient echocardiogram waiting list for investigation of HF
3. Individuals with a previous ICD-10 diagnosis of HF in any coding position
4. Inability of the participant, in the opinion of the investigators, to understand and/or comply with study procedures, or any conditions that, in the opinion of the investigators, may render the participant unable to understand, attend and/or undergo study visit investigations
5. Inability to read and understand the PIS (provided in English only), and understand the research team
The Effect of Eszopiclone on the Arousal Threshold in Sleep Apnea Syndrome

The purpose of this study is to find out whether taking eszopiclone (Lunesta) changes the breathing effort required to briefly wake people with obstructive sleep apnea from sleep (respiratory arousal threshold). We would like to see if taking eszopiclone can reduce the severity of obstructive sleep apnea in some people (those that have a low respiratory arousal threshold; i.e. wake up easily to respiratory stimuli).

Obstructive sleep apnea is an exceedingly common disease with major neurocognitive and cardiovascular consequences. The current primary treatment e.g. Continuous positive airway pressure (CPAP) is effective but poorly tolerated by many patients particularly those with mild-moderate disease. Secondary treatments such as oral appliances to advance the mandible or surgical procedures to enlarge the airway are commonly appealing to the patient. However, these approaches have only modest success in reducing apnea frequency to an acceptable level. Thus, finding tolerable and effective therapy for sleep apnea remains an important objective.

The causes of sleep apnea vary between patients. Targeted therapy according to the underlying causes of sleep apnea in individual patients is likely to be most effective. However, current therapeutic options for sleep apnea are quite limited. The purpose of this physiological research study is to determine if taking eszopiclone (Lunesta)changes the breathing effort required to briefly wake people with obstructive sleep apnea from sleep (the arousal threshold) and if administration of the sedative medication eszopiclone (Lunesta) to certain sleep apnea patients (those with a low arousal threshold ie wake up easily) would be beneficial.

Eligibility Criteria:
Inclusion Criteria:

* 18-64 years old
* Untreated obstructive sleep apnea

Exclusion Criteria:

* Nadir SaO2 \<70% on a baseline PSG
* Medications known to affect either sleep, breathing or muscle activity
* Major co-morbidities apart from sleep apnea
* Allergy to lidocaine, oxymetazoline HCl, or eszopiclone
* Women who are pregnant
EVALUATION OF BLOOD BIOMARKER-BASED DIAGNOSTIC AID IN OUTPATIENTS SUFFERING FROM DEPRESSION

This is an observational (non-interventional) study, carried out in an outpatient setting, which involves a blood sampling. The primary objective of this study is to confirm the association between the EDIT-B® editing signature and early unipolar or bipolar differentiation. Results of this research may provide an aid to early diagnosis and guide clinical practice towards individualized treatment.


Eligibility Criteria:
Inclusion Criteria:

Adult outpatients suffering from depression and/or bipolar disorders who gave their written informed consent to participate in the present study

Exclusion Criteria:

Any patient without capacity of discernment or with harmful use of psychoactive substances
Remote Monitoring of Patients With COPD

This clinical investigation will evaluate the patient-equipment interface and patient preference in the use of modern possibilities for remote monitoring of patients with COPD in a personalized care approach.

The primary objective is to evaluate the impact and feasibility of tele monitoring and video contact in personalized care of moderate and severe COPD patients. This should be compared to normal standards of care. The cross-over design evaluates the influence on general HRQOL of this tablet and monitoring system.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to participate and provision of informed consent
* Diagnosis of COPD
* FEV1/FVC (post bronchodilator) \<0.7
* GOLD severity grade D
* FEV, \< 80% predicted
* Cognitive ability relevant for the studies as judged by the investigator
* Living in their own home and able to manage their activities of daily living

Exclusion Criteria:

* Rapidly progressing severe disease other than COPD and COPD-related diseases, influencing the Health-Related Quality of Life (HRQOL) during the study time as judged by the investigator
* Long-term stay ( \>2 weeks) away from home during the study period, where there are no possibility to get internet connection
* COPD exacerbation during 1 month before start of study
PRospective Evaluation of Interstitial Lung DIsease Progression With Quantitative CT

The interstitial lung diseases (ILD) are a heterogenous group of conditions with varying degrees of inflammation and scarring (fibrosis) of the lungs. ILD progression is unpredictable, making prognostication challenging. A proportion of patients will develop inexorably progressive disease termed progressive fibrosing ILD (PF-ILD).

Forced vital capacity (FVC), a lung function variable, is routinely used to monitor disease progression. However FVC can be a poor disease marker as it can be influenced by patient effort and can be difficult to perform. High resolution computed tomography (HRCT) is a necessary investigation for suspected fibrotic-ILD, making it a promising tool for research.

A quantitative-CT (qCT) approach uses computer software to analyse HRCT scans and has advantage over visual radiologist assessments which are limited by inter/intra-observer variance. The investigators will undertake a feasibility study to determine whether baseline and longitudinal qCT can predict and quantify disease progression in fibrotic-ILD.

The endothelial glycocalyx (EG) is a mesh-like layer that lines the small blood vessels. Injury to this layer has been implicated in non-thoracic fibrotic diseases. Telomeres are repetitive genetic sequences which cap chromosomes preventing their damage during cell replication. Prematurely shortened leucocyte telomere lengths (LTL) have been demonstrated in a wide range of ILDs. We will evaluate role of measuring EG health and LTL in disease prognostication.

Adult participants with fibrotic-ILD from 3 centres in England will be recruited alongside healthy controls. Case (disease) participants will undergo investigations at 0, 6 and 12 months from recruitment including:

* HRCT with quantitative analysis (qCT)
* Lung function testing
* EG and LTL measurement
* Health related quality of life assessments

The primary outcome will assess the correlation of disease progression status measured by standard of care (FVC) with baseline qCT and EG assessment. Healthy controls will only undergo EG assessment at all time points. Feasibility outcomes will be assessed including recruitment, consent and attrition rates.

The results will inform a subsequent multi-centre study to assess the clinical benefit of disease monitoring with the measures assessed in this study.


Eligibility Criteria:
Inclusion Criteria:

* Multidisciplinary team diagnosis of IPF or non-IPF fibrotic-ILD
* Treatment naivety to anti-fibrotic therapy at entry to study
* Adult ≥18 years \<85
* Informed consent

Exclusion Criteria:

* Forced expiratory volume in 1s/FVC \<0.7,
* Significant other respiratory pathology including emphysema \>15% on CT (radiologist determined)
* Evidence of ILD exacerbation at the time of CT
Effectiveness of an Intervention Program for Fine Motor Skills

Investigators have created a protocol of intervention to treating the general disability of upper limbs.

A protocol of intervention for fine motor skills will be performed on institutionalized elderly people.

This protocol consist on implementation of a manual activity that it is well known in the clinical setting.

This activity will enhance several skills such as strength, coordination of upper limbs, range of motion, general auto-efficacy and the quality of life.

The intervention or rehabilitation will be implemented for two month.

Eligibility Criteria:
Inclusion Criteria:

* Institutionalized elderly people, on a full or part-time.
* Voluntary participation.

Exclusion Criteria:

* Cognitive impairment (\< 23 in normal school population and \< 20 points with a low education or illiteracy, in Spanish validation of Mini-Mental State Examination (MMSE)).
* Postural control problems.
* Balance disorders, while the subject is seated.
Bleeding Risk in CVCs

Since many of the patients in an intensive care unit suffer from disorders of hemostasis, bleeding is a main concern applying central venous catheters. Even if there are some data indicating elevated international normalized ratio may not increase the risk of bleeding no clear cut-off has been defined so far. An INR \> 1.5 is generally considered to increase the risk of bleeding. Furthermore, many authors consider platelets below 50 x 109 /l as a contra-indication to CVC cannulation, since there are some data this may increase the risk of bleeding. Therefore platelet transfusion before venous puncture is suggested. In our clinical experience INR \> 1.5 and platelets \< 50 x 109 /l do not correlate with increased risk of bleeding. The aim of this study is to demonstrate, that coagulopathy, defined by INR and platelet count, is not decisive for bleeding.


Eligibility Criteria:
Inclusion Criteria:

* All patients acquiring a central venous catheter

Exclusion Criteria:

* Patients pre or post surgery
* Patients with bleeding due to other reason
Clinical Efficacy and Adverse Reactions of Antipsychotic Treatment

The goal of this clinical trial is to explore the potential of metformin in managing olanzapine-induced metabolic disturbance and hyperprolactinemia in patients with schizophrenia. The main questions it aims to answer are:

1. The effect of metformin on olanzapine-induced metabolic disturbance
2. The effect of metformin on olanzapine-induced hyperprolactinemia

Participants will receive metformin 1500 mg/day for 8 weeks and assessments every 2 weeks.

The study was conducted in an inpatient setting, with the dosage of olanzapine remaining consistent throughout the study duration. All participants were administered 1500 mg/day of metformin for eight weeks. Vital signs were measured daily. Physical and neurological examinations were carried out on a weekly basis. Every two weeks, all participants underwent an assessment for general psychopathology. Blood samples were collected in the morning after an overnight fast at the beginning of the study and then every two weeks following the commencement of metformin treatment. Serum prolactin levels were determined through electrochemiluminescence immunoassays. Fasting serum levels of glucose, total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglycerides were measured using enzymatic colorimetric assays. Serum insulin and leptin levels were measured using electrochemiluminescence immunoassay kits.

Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 60 years
* diagnosed with schizophrenia under the Diagnostic and Statistical Manual of Mental Disorders-fourth edition criteria
* had been consistently treated with a stable dose of olanzapine for a minimum of three months

Exclusion Criteria:

* Exclusion criteria encompassed any mental disorder other than schizophrenia, ongoing substance abuse, and medical conditions that could interfere with glucoregulatory and endocrine assessment such as diabetes mellitus and other endocrine disorders. Additionally, severe cardiovascular, hepatic, or renal diseases, malignancy, epilepsy, and pregnancy were also reasons for exclusion.
Evaluation of Fiit-ns® in Health-related Quality of Life Improvement in Overweight and Obese Subjects

The purpose of this study is to evaluate the effects of a 16-week supplementation with a polyphenol-rich extract, Fiit-ns®, on improvement of health-related quality of life (HR-QOL) of overweight and obese volunteers, as compared to placebo. Previous beneficial results from a pilot study showed that the supplementation may improve quality of life as well as body composition. Based on such results, this pivotal study is statistically powered to detect significant differences in HR-QOL assessed with the Short Form-36 Health survey (SF-36) between baseline (Week 1, W1) and end of the supplementation period (Week 16, W16).


Eligibility Criteria:
Inclusion Criteria:

* 25 kg/m2 ≤ Body Mass Index (BMI) ≤ 40 kg/m2
* 25-55 years old

Exclusion Criteria:

* Metabolic and/or chronic disease (diabetes, dyslipidemia, thyroiditis, inflammatory disease, immunological disease, asthma, anxiety, depression)
* Allergy to one of the ingredients of the supplement
* Current involvement of involvement within the 6 previous months in a chronic supplement program, chronic treatment program, weight loss program
* Smoking cessation
* High alcohol consumption
* Pregnancy
* Breastfeeding
* Menopausal women
* Involvement in physical activity more than twice a week
Diagnostic and Prognostic Value of Lung Microbiota in Early Lung Infection After Lung Transplantation

The present study is a prospective case-control study. Patients were enrolled post lung transplantation and alveolar lavage fluid was obtained within 48 hours of the patient's surgery, divided into aliquots and subjected to macrogenomic sequencing, routine microbiological testing and cytokine testing. Patients were divided into pulmonary infection and non-pulmonary infection groups based on whether they had a co-infection at the time of sampling. Pulmonary infection was used as the primary study endpoint. To describe and compare the characteristics of the lung microbiota in the two groups and to determine whether variation in the lung microbiota could predict the development of lung infection and prognosis in patients in the early post-transplant period.

Lung infection is a common and serious problem in the perioperative period of lung transplantation, and early diagnosis of lung infection is important, while traditional culture methods are time-consuming and have low positivity rates. Pathogenic detection by macro-genomic sequencing (mNGS) may be useful for early and rapid diagnosis of post-operative infections, and the simultaneous detection of lower respiratory tract microbiota may also be useful for early diagnosis of infections. However, the use of lung microbiota in the perioperative period of lung transplantation in the setting of pulmonary infections is still at an exploratory stage. The present study is a prospective case-control study. Patients in the MICU after lung transplantation were enrolled, and alveolar lavage fluid was obtained within 48 hours of the patient's surgery, divided into aliquots, and subjected to macrogenomic sequencing, routine microbiological testing and cytokine testing. Patients were divided into pulmonary infection and non-pulmonary infection groups based on whether they had a co-infection at the time of sampling. Pulmonary infection was used as the primary study endpoint. To describe and compare the characteristics of the lung microbiota in the two groups and to determine whether variation in the lung microbiota could predict the development of lung infection and prognosis in patients in the early post-transplant period. To explore the diagnostic thresholds of common lung pathogens by macrogenomic sequencing in patients with co-infections in the early post-transplant period

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the ICU for lung transplantation; consent for bronchoscopy; informed consent signed by the patient or their representative.

Exclusion Criteria:

* Patients admitted to ICU for other serious illnesses; patients more than 48 hours after lung transplantation; patients predicted to die within 48 hours; participation in other clinical studies; failure to sign an informed consent form.
Comparison of Inferior Oblique Muscle Recession and Myectomy

The purpose of this study is to compare muscle recession and myectomy on inferior oblique muscle overactivity.


Eligibility Criteria:
Inclusion Criteria:

* Overactivity of Inferior Oblique Muscle \>= 2

Exclusion Criteria:

* Nystagmus
* History of vertical muscle operation
* Mechanical limitation
* Eye disease
* Paralysis
Training Early Social Language in Autism

The aim of the study is to determine whether a targeted behavioral intervention can lead to both changes in early communication skills and in neural responses in toddlers and preschoolers with autism.

The mirror neuron system (MNS) broadly refers to a network of brain regions that responds both when a person performs an action and when that person observes someone else performing the same action. This system emerges in infancy and develops over time to support more complex social abilities. It has been hypothesized that autism involves fundamental impairments to the MNS, which can explain the deficits in joint attention, imitation, communication and social cognition.

This study investigates the MNS in 100 toddlers and preschoolers recently diagnosed with autism or with a suspected diagnosis of autism. First, children with (suspected) autism complete a battery of behavioral measures and MNS activity will be assessed using electrophysiology (EEG; event-related potentials) while the child participates in specific tasks. Then, the children with (suspected) autism will be randomly assigned to one of two behavioral intervention programs (i.e., targeted joint attention intervention or parent education intervention) that will be carried out by interventionists and parents for 10-12 weeks. At the end of the intervention, these children will be re-evaluated on behavioral tasks and EEG to investigate changes as a result of the intervention.

The investigators hypothesize that the joint attention intervention will lead to significant changes on both the neural and behavioral measures of MNS functioning.

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 18 and 59 months with a confirmed or suspected DSM5 diagnosis of autism spectrum disorder
* The included parents or guardians are required to be the primary caregivers of these children
* Families must speak English in the home at least 75% of the time.

Exclusion Criteria:

* Seizure disorder (may influence EEG data)
* Gestational age \<32 weeks
* History of serious head trauma
* Genetic syndrome (e.g., fragile X syndrome)
Effects of Lutein Supplementation on Cognition and MPOD in Multiple Sclerosis Patients-

The central hypothesis is that lutein supplementation will improve MPOD and cognition. Accordingly, the specific aims are to 1) to determine the process feasibility associated with participating in 4-month lutein supplementation trial; and 2) to investigate the scientific feasibility of 4-month daily lutein supplementation on biological markers of lutein status and cognitive function among persons with MS.

A two-group parallel design will be employed whereby participants will be randomly assigned to one of 2 groups. The supplementation doses 20mg/d (Group 1), and placebo (Group 2) will be consumed daily by the participant for a 4-month period. Pre-test and follow-up measures of lutein status and cognitive function will be assessed at baseline and at 4-month follow-up via laboratory visits.

Eligibility Criteria:
Inclusion Criteria:

* 18-64.9 years
* Self-reported relapsing-remitting MS (RRMS) diagnosis
* Expanded Disability Status Scale (EDSS) score between 0-3.5
* Macular Pigment Optical Density at baseline (MPOD ≤0.35)
* Score ≤55 during the Symbol Digit Modalities Test (SDMT)
* 20/20 or corrected vision
* No presence of color blindness
* No history of age-related macular degeneration
* No history of epileptic seizures

Exclusion Criteria:

* Under 18 years or over 64.9 years
* MS diagnosis other than RRMS
* Pregnancy
* Uncorrected vision
* Presence of color blindness
* PDDS score of 7 or more
* Prior diagnosis of age-related macular degeneration
* History of epileptic seizures
Expandability of Aging Adipose Tissue

The purpose of this pilot study is to determine whether adipose tissue loses some of its ability to expand in response to overfeeding in older compared to younger men. The investigators hypothesize that the adipose tissue response to overfeeding may be weakened in older when compared to younger men, thereby leading to worsened ectopic storage depots for older men.

This pilot study will begin to address whether adipose tissue biology changes with advancing age. Specifically, we will test whether adipose tissue loses some of its ability to expand in response to overfeeding in older compared to younger men. To test this possibility the Investigators will recruit overweight and mildly obese older (age 55-75y) and younger (age 25-40y) men and collect adipose tissue biopsies before and after 7 days of overfeeding. The investigators will test how well the cells in adipose tissue expand in response to overfeeding and whether this differs between younger and older men.

Eligibility Criteria:
Inclusion Criteria:

* Men
* Aged 25-40y OR 55-75y
* BMI 28-35 kg/m2
* Weight stable (±2kg over past 3 mo)
* Sedentary to moderately active (\<3 d/wk of exercise lasting \>20min)
* Non-smokers (never used or quit \>7yrs prior)

Exclusion Criteria:

* Women
* Currently using hormones, glucose or lipid lowering medication
* Engaged in exercise or diet program
* Currently gaining or losing weight or using weight loss drugs
* Diabetes mellitus (diagnosis, treatment, FBG ≥126 mg/dL)
* Uncontrolled metabolic disorders (e.g., thyroid)