cyrilzakka/clinical-trials huggingface dataset:
Hypocholesterolemic Effect of a Phytosterol-enriched Spreadable Cream Prepared With Virgin Olive Oil

This study aims to evaluate the effect of the enriched extra virgin olive oil spread in plant sterols from the olive itself and demonstrate its effect anticholesterolemic and cardioprotective in children and adolescents with hypercholesterolemia.

A clinical study of nutritional intervention, randomized with double blind, adjusted by randomization blocks that consider age and sex, and crossover of 2 months duration each period, with 1-month washout period, in 50 subjects (25 per randomization group). The study will be carried out in the Reina Sofía Universitary Hospital of Córdoba, as well as at the Institute of Nutrition and Food Technology of the University of Granada.

The effects of the enriched spread in patients on the lipid profile will be evaluated plasma and its action on biomarkers of cardiovascular risk and on the microbiota intestinal depending on the specific genotype of each subject. In addition, the presence of minor olive oil compounds present in plasma (metabolomic analysis). In this way, at the end of the project, scientific information will be available contrasted on the enriched product and its effects on cardiovascular protection, in addition to its palatability and acceptance.

The main objective is to evaluate the effect of the enriched extra virgin olive oil spread in plant sterols from the olive itself and demonstrate its effect anticholesterolemic and cardioprotective in children and adolescents with hypercholesterolemia.

As specific objectives will be determined:

* To evaluate the effect of the enriched spread on the plasmatic concentrations of total cholesterol, LDLc and other parameters of the lipid profile
* To evaluate the effect of the enriched spread on the oxidative status of LDL plasmatic
* To evaluate the effect of the enriched spread on the antioxidant defense system
* To evaluate the effect of the enriched spread on biomarkers of cardiovascular risk, including inflammatory and endothelial damage markers
* To evaluate the effect of the enriched spread on the intestinal microbiota.
* To evaluate the effect of the enriched spread on the metabolomic changes in plasma.
* To analyze the specific genotype of each volunteer

Eligibility Criteria:
Inclusion Criteria:

* Age between 6 and 18 years
* Familial hypercholesterolemia
* Acceptance to participate by signing the informed consent

Exclusion Criteria:

* Children under 6 years of age
* Absence of hypercholesterolemia
* Children who receive some type of medication to control hypercholesterolemia, blood pressure, levels of glucose or dyslipidemia or any probiotic, which have invalid data for the variables of the present study
* Not to sign the informed consent.
Dry Eye Evaluation After Transepithelial PRK

The aim of the study is to evaluate the severity of dry eye syndrome following excimer laser vision correction using no-touch all-laser photorefractive keratectomy in comparison to conventional lasik

Prospective interventional clinical study 2 groups: Group A : 20 eyes of 10 patients undergoing transepithelial PRK Group B: 20 eyes of 10 patients undergoing LASIK using mechanical microkeratome Tear Break Up Time and Schirmer 2 tests are used to evaluate severity of dry eye before surgery and 1 , 3 and 6 months postoperative Follow up period : 6 months

Eligibility Criteria:
Inclusion Criteria

* Myopia -1 to -6 diopters
* Astigmatism -0.5 to - 4 diopters

Exclusion Criteria:

* Pregnancy and lactation
* Keratoconus
* Previous refractive surgery
* Previous herpetic keratitis
Predict Recurrence of Barrett's Esophagus After Complete Eradication of Intestinal Metaplasia

Researchers are trying to see if the Nvision® Imaging System (VLE) can accurately determine the risk of recurrent Barrett's esophagus in patients with Barrett's esophagus which have been clear of disease.

Patients with Barrett's Esophagus (BE) undergoing endoscopic therapy through our Barrett's Esophagus Unit will be approached for study enrollment. Patients with no endoscopic evidence of BE will be considered for the study. Surveillance biopsies will be obtained per standard clinical protocol and reviewed to confirm absence of intestinal metaplasia. Patients who have achieved complete eradication of intestinal metaplasia (CRIM) will be enrolled in the study and will undergo the Nvision® Imaging System (VLE). Patients enrolled in the study will undergo clinical follow-up consisting of surveillance endoscopy every 3 months for 1 year. Surveillance endoscopy intervals may be prolonged to every 6 months in the second year, and annually thereafter. At each follow-up visit, endoscopic data will be collected to determine if patients remain in CRIM or show evidence of recurrent disease. Patients will be followed for 1 year (endpoint 1) and 3 years (endpoint 2).

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Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing an upper endoscopy with prior biopsy confirmed Barrett's Esophagus.
* Ability to provide written, informed consent
* No significant esophagitis (LA grade \<B, C, and D)

Exclusion Criteria:

* Patients for whom use of the NvisionVLE device would be in conflict with the instruction for use.
* Prior esophageal or gastric surgical resection
* Significant esophageal stricture requiring dilatation
* Patients who require anti-coagulation for who biopsy would be contraindicated
* Patients who are known to be pregnant
Impact of a Printed Decision Aid on Cataract Surgery Choice

The purpose of the study is to explore whether a decision aid booklet is more effective than the usual booklet for patients to make an informed choice on cataract surgery.

Shared decision making is increasingly recommended to facilitate quality care, but there is a lack of cataract surgery decision aid in clinical practice. The aim of this study is to evaluate the effectiveness of a cataract surgery decision aid for cataract patients with different levels of health literacy.

We will conduct a randomized controlled trial for cataract patients aged 50-80 years. We will randomly assign participants to either the intervention using a decision aid booklet or the one using a usual cataract booklet. The primary outcome is informed choice (defined as adequate knowledge and consistency between attitudes and intentions) 2 weeks after intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Definite diagnosis of age-related cataract;
2. The best corrected visual acuity (BCVA) is above 20/60;
3. Cataract opacity meets any of the following criterion based on lens opacity classification system (LOCS) III: nuclear color and nuclear opalescence is greater than or equal to grade 2 (NO2/NC2); cortical opacity is greater than or equal to grade 2 (C2); posterior subcapsular opacity is greater than or equal to grade 2 (P2);
4. Willing to know about cataract and cataract surgery;
5. Being able to afford cataract surgery;
6. Willing to participate in the study and provide the informed content.

Exclusion Criteria:

1. Having received cataract surgery;
2. Having hearing disorders;
3. Having mental disorders;
4. Having ocular disorders other than cataract;
5. Having surgery contraindication;
6. Unwilling to participate in this study.
Phase II Study of Gefitinib Plus Nimotuzumab Versus Gefitinib in Non-small Cell Lung Cancer

Combining nimotuzumab to gefitinib may not only potentiate cellular cytotoxicity, but may also assist in overcoming inherent or acquired resistance to gefitinib alone.

Reversible EGFR tyrosine kinase inhibitors (TKI), such as gefitinib, were shown to be effective in patients with non-small cell lung cancer (NSCLC). However, patients almost invariably develop resistance to TKIs and have disease progression. Nimotuzumab is a humanized monoclonal antibody targeting the EGFR.

Combining nimotuzumab to gefitinib may not only potentiate cellular cytotoxicity, but may also assist in overcoming inherent or acquired resistance to gefitinib alone.

Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent prior to any study specific procedures
* Unresectable non-small cell lung cancer
* ECOG performance status of 0 to 2
* Male or female; ≥ 20 years of age
* Subjects whose disease has progressed after platinum-based chemotherapy
* Subjects with measurable lesion

Exclusion Criteria:

* Inadequate organ functions
* Disease progression after 2 or more previous chemotherapy regimens
* Prior therapy with EGFR-tyrosine kinase inhibitor or Anti-EGFR Monoclonal Ab
* Any clinically significant gastrointestinal abnormalities
* Past medical history of interstitial lung disease
* Pregnant or lactating female
Alexithymia and Attachment Style in Patients With Somatic Symptoms

To evaluate whether emotional awareness, attachment style and the ability to abstract and symbolize (IQ) influence the appearance of somatic symptoms. Hypothesis: the investigators expect the presence of somatic symptoms linked to the lower ability of emotional awareness, to lower ability to abstract and symbolize and to an insecure attachment style.

Somatic Symptom Disorder (eg pain, weakness, chronic fatigue) represents one of the main reasons why patients seek specialist medical advice. Although the symptoms often manifest themselves in a disabling form and there are numerous medical examinations to which patients undergo, these do not seem to find an organic confirmation to their problem and consequently the patients do not receive a specific diagnosis. These are usually transient symptoms but it can happen that they become persistent and chronic, going to constitute themselves as real somatic syndromes. The study investigates the psychological and family aspects that seem to characterize somatic and chronic pain symptoms in pediatric age. In addition to this objective, the study aims to quantify the health costs incurred in the diagnostic phase prior to the classification of the somatic symptom. These elements would make it possible to achieve greater knowledge of clinical pictures and the identification of useful markers for the clinician to make early diagnoses and guide patients in a global and timely care.

Eligibility Criteria:
Inclusion Criteria:

* Clinical condition characterized by somatic symptoms such as recurrent abdominal pain, recurrent vomiting, dyspepsia, psychogenic cough, and chronic functional pain (headache, migraine, musculoskeletal pain) for which an organic cause has been excluded and whose symptom has had a strong impact on the quality of life (presence of the symptom for six months, school absenteeism, social isolation, immobility, psychological distress, difficulty in participating in sports and extracurricular activities, etc.), as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria.
* Age between 11 and 17 years
* Italian speaking
* Patients' and parents' consent

Exclusion Criteria:

* Cognitive and/or developmental impairment
* Difficulty in understanding the Italian language
* Presence of organic disease diagnosis
* Lack of informed consent
* Patient who does not meet DSM-5 criteria for somatic symptom disorder

Caregiver exclusion criteria:

* Cognitive deficits
* Difficulty in understanding the Italian language
* Lack of informed consent

Control group population inclusion criteria:

* Age between 11 and 17 years
* Adequate knowledge of the Italian language
* Consent to participate
Outcomes Of Social Service Programs For Homebound Older Adults

The objective of this prospective study is to document the impact of social service interventions (including meals, telephone reassurance, and friendly visiting)provided by the Burden Center, a model community social service agency, on overall quality of life.

Specific outcomes include mental and physical function as measured by the SF-36, and depressive symptoms as measured by the CES-D depression scale. The hypothesis is that a multicomponent social service intervention program that provides social support and reduces social isolation can prevent depression and decline in quality of life in this vulnerable population.

Eligibility Criteria:
Inclusion Criteria:

* All new clients of the Burden Center for the Aging who are homebound, out of the home less than one time per week, and cognitively intact will be eligible for enrollment.

Exclusion Criteria:

* Clients unable to give informed consent such as those suffering from a major psychiatric disease or those who are not cognitively able to give informed consent will be excluded.
* Clients who refuse to participate will be excluded
Amyloid Prediction in Early Stage Alzheimer's Disease From Acoustic and Linguistic Patterns of Speech - FUTURE Extension

The primary objective of the study is to evaluate whether a set of algorithms analysing acoustic and linguistic patterns of speech, can predict change in PACC5 between baseline and +12 month follow up across all four Arms, as measured by the coefficient of individual agreement (CIA) between the change in PACC5 and the corresponding regression model, trained on baseline speech data to predict it. Secondary objectives include (1) evaluating whether similar algorithms can predict change in PACC5 between baseline and +12 month follow up in the cognitively normal (CN) and MCI populations separately; (2) evaluating whether similar algorithms trained to regress against PACC5 scores at baseline, still regress significantly against PACC5 scores at +12 month follow-up, as measured by the coefficient of individual agreement (CIA) between the PACC5 composite at +12 months and the regression model, trained on baseline speech data to predict PACC5 scores at baseline; (3) evaluating whether similar algorithms can classify converters vs non-converters in the cognitively normal Arms (Arm 3 + 4), and fast vs slow decliners in the MCI Arms (Arm 1 + 2), as measured by the AUC, sensitivity, specificity and Cohen's kappa of the corresponding binary classifiers. Secondary objectives include the objectives above, but using time points of +24 months and +36 months; and finally to evaluate whether the model performance for the objectives and outcomes above improved if the model has access to speech data at 1 week, 1 month, and 3 month timepoints.


Eligibility Criteria:
Inclusion Criteria:

* Subjects are fully eligible for and have completed the AMYPRED (Amyloid Prediction in early stage Alzheimer's disease from acoustic and linguistic patterns of speech) study.

(See https://clinicaltrials.gov/ct2/show/NCT04828122)

* Subject consents to take part in FUTURE extension study.

Exclusion Criteria:

* Subject hasn't completed the full visit day in the AMYPRED study.
Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes

This study will assess whether dietary fiber supplements can reduce the production of chemicals which are produced by colon bacteria and normally excreted from the body by the kidney, but build up in the body in patients on hemodialysis.

The study procedures will consist of:

* taking a dietary supplement containing either fiber or starch (starch serves as a control for fiber) for six weeks. The fiber dose initially employed will be 30 g/day of high amylose corn and the control starch dose employed will be 30 g/day of waxy corn starch. Supplements which come in dry powder form will be mixed in liquid or food for consumption.
* filling out a food record and a quality of life questionnaire
* keeping a diary of any gi symptoms
* collecting samples of blood, spent dialysate, urine(if the patient still makes urine) and stool.

Eligibility Criteria:
Inclusion Criteria:

* stable dialysis patients able to provide consent.

Exclusion Criteria:-- known g.i. disease

* use of antibiotics for the last two month or expected antibiotic use
* recent hospitalization or other event resulting in instability of food intake
Frequency of Diagnostic Symptomatic Pulmonary Embolism's in Patients Hospitalized for Clinical Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

A standardized diagnostic strategy of pulmonary embolism will be applied to eligible patients, incorporating a clinical probability score (revised Geneva score), plasma D-dimer assay and if necessary, a multidetector-row CT angiography thoracic and venous ultrasound of the lower limbs. All the patient with a pulmonary embolism diagnosed or not, will be followed for 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized for a COPD exacerbation
* COPD previously diagnosed

Exclusion Criteria:

* Allergy to iodinated contrast
* Creatinine clearance \< 30 mL / min
* Patient hospitalized for exacerbation of COPD for more than 48 hours
* Pneumothorax
* Exams impossible to be performed
* Pregnancy
* Life expectancy \< 3 months
* Patients already receiving anticoagulant therapy for another reason (mechanical valve, cardiac arrhythmia).
Endoscopic Ultrasound Guided Tissue Sampling (The SharkBITE Study)

This study compares the diagnostic performance of Endoscopic ultrasound (EUS) guided fine needle aspiration and EUS guided core biopsy (SharkCore) in patients with a solid pancreatic mass.

Endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and fine needle biopsy (FNB) are the standard methods for obtaining tissue samples from tumours of the pancreas. The diagnostic accuracy by strict criteria is around 75-80%. A non diagnostic sample causes delay and the need for a repeat procedure. To date no significant difference has been found between standard FNA and standard FNB needles. A novel opposing bevel design (SharkCore) needle for FNB may provide better diagnostic performance. The aim of this study is to compare the performance of a standard needle and the Sharkcore needle. Patients attending for routine biopsy of a suspected pancreatic tumour will be invited to participate. All participants will have 3 samples taken with each needle. The samples from each needle will be processed and reported separately with the pathologists blinded as to the report from the other needle. Following the procedure participants will be observed as normal in the recovery area and allowed home later. Further study participation is limited to 1 telephone call at 7 days. Participants will be asked if they have developed any new symptoms since the procedure and whether they have had to seek medical attention for this.The risks of the study procedure are the same as those of a non study procedure. Both needle types are in routine use in our unit. The study will be performed in the endoscopy unit of the Freeman hospital. The study is funded by a grant from Medtronic the company who make the Sharkcore needle. The study is planned to recruit 108 participants over 10 months with a further 6 months of follow up. If the new needle is found to perform better its routine use will potentially reduce the delay experienced by patients as well as the cost incurred by repeat procedures.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18 years and above with a solid pancreatic mass of any size, needing to Undergo the EUS examination to collect sample for diagnosis will be recruited for the study. The definition of a solid pancreatic mass will be based on an ultrasound or a CT scan result or based on the findings of a EUS examination done prior.
* Patients should have the ability and be willing to give informed consent

Exclusion Criteria:

* Cysts that do not have a significant solid component will be excluded
* Any contraindication to pancreatic biopsy.
Effects of a Small Protein and Lipid Preload on Glucose Tolerance in Subjects With Impaired Glucose Homeostasis

The purpose of this study is:

* to measure the size of the effect on glucose tolerance of a small mixed protein and lipid meal given as a pre-load in individuals with different glucose tolerance status
* to investigate the underlying mechanisms by accurately evaluating beta cell function, insulin sensitivity, insulin clearance and glucose kinetics (oral absorption, endogenous production, rate of utilization) together with gut hormones plasma concentration.

As supported by experimental and clinical data, oral carbohydrate tolerance is influenced by the coingestion of nutrients through multiple mechanisms. The ingestion itself, the contact with the gastric mucosa, the arrival into the intestine and the subsequent digestion are known to produce neural reflexes, hormonal responses and plasma substrates gradients which, by modulating gastric emptying, insulin secretion and insulin clearance participate in the regulation of postprandial glycaemia. The size of this effect is influenced by a number of factors: the specific nutrient chemical characteristics (fat vs protein and composition) and their physical properties (solid vs liquid), the timing (pre-load vs coingestion) and finally the individual glucose tolerance status. To our knowledge, the effect on glucose excursions of a combination of protein and fat given before carbohydrate is still unknown and also unknown is the contribution of different mechanisms involved in the control of glucose homeostasis in subjects with different degrees of glucose tolerance.

Eligibility Criteria:
Inclusion Criteria:

* healthy, prediabetic or diet-controlled type 2 diabetic patients
* Subjects ≥ 18 and ≤65 years of age
* Lean, Overweight or Obese (BMI: 18 to 35 kg/m2)
* Normal liver and kidney function
* Normal thyroid function
* Read and understood the informed consent form and signed it voluntarily

Exclusion Criteria:

* Liver, heart, kidney, lung, infectious, neurological, psychiatric, immunological or neoplastic diseases.
* Type 1 or insulin treated diabetes.
* Pregnancy or lactation
* Illicit drug abuse or alcoholism
* Subject treated with insulin or treatment
* Subjects taking anoretic drugs
* Subjects on steroid treatment
* Subjects after bariatric surgery.
REEV SENSE for Gait Analysis in Post-stroke Gait Impairment (SENS-AG)

The purpose of this study is to evaluate the clinical performance of the investigational REEV SENSE gait tracker to measure gait features in subjects with post-stroke gait impairment.

REEV SENSE is intended to be used by trained healthcare professionals as a simple procedure adapted to clinical routine.

The reference method for performance comparison will be motion capture.

REEV SENSE is a medical device, with pending FDA and CE certifications in class 1. It is a connected gait tracker set primarily on the leg or foot, and eventually on lower limb locations. It contains an accelerometer, a certified standard battery and motion analysis algorithms that will rapidly compute easy-to-use walking analyses accessible to healthcare professionals on a mobile app.

Standard gait biomarkers such as velocity, stride length, or stance and swing times will be computed. However, REEV has also developed a new biomarker, the knee position predictor (KPP), which will provide a more accurate quantification of each individual gait profile.

The present REEV SENSE study is the first to test subjects with a pathological context, i.e. with post-stroke ambulation deficit. Performance of REEV SENSE has already been established in healthy volunteers in comparison to the reference motion capture system, indicating good technical and metrological performance.

The study will take place at the MIT Center for Clinical and Translational Research (CCTR), a reference center with a fully equipped gait lab.

Each participating volunteer will be equipped with REEV SENSE and the reference motion capture system. The participant will be asked to walk at a comfortable self selected pace for about 15 minutes back and forth along a 10m walkway. He or she may rest at any time during the walking session. REEV SENSE and motion capture data will be recorded automatically and simultaneously during the same walking session.

Eligibility Criteria:
Inclusion Criteria:

* Post-stroke gait disorder.
* Must be able to walk independently with or without the support of a cane or rollator.
* History of stroke more than six months ago.
* Be 18 years of age or older.

Exclusion Criteria:

* Subject unable to give consent.
* Subject unable to understand the tests.