cyrilzakka/clinical-trials huggingface dataset:
San Raffaele EoE Biobank

Eosinophilic Esophagitis (EoE) is a immuno-mediated disease, characterised by a Th-2 food-antigen driven chronic inflammatory response of the esophagus. Main symptoms are dysphagia and food bolus impaction, frequently overlapping with most atypical and general symptoms like heartburn or regurgitation and difficulty to thrive in children. Overall incidence and prevalence of EoE are rapidly increasing. The complete comprehension of pathogenetic and molecular mechanism underlying this complex and relatively new disease is still to be conquered. For this reason, we created this EoE Biobank, in order to collect blood, oral and esophageal tissue samples of proven EoE patients to further exploit new insights of this disease.

Every EoE patient pertaining to the EoE Unit of San Raffaele Hospital in Milan from 1st June 2023 will be enrolled in the EoE Biobank protocol after being adequately informed and after having signed the informed consent during a preliminary visit where also different clinical and demographic variable of each patient will be taken and stored in an anonymus database. Every patient, during the endoscopic examination performed according to clinical practice guideline for his management, will be asked to provide a sample of oral saliva, 5 mL of blood sample (directly withdraw from the previously placed venous catheter) and additional esophageal biopsies from the esophagus, normally performed for the diagnosis or the follow-up of the disease. The collected samples will be stored in Biological Resources Centre (BRC) of the host organization. These sample will later be analyzed "in vitro" in the context of dedicated protocols

Eligibility Criteria:
Inclusion Criteria:

* EoE diagnosis proven histologically with clinical activity
* Age \> 16 years

Exclusion Criteria:

* Not signed informed consent
* No definite EoE diagnosis
Clinical Trial Comparing TACE With TACE + SABR in Stage BCLC B HCC (HepSTAR)

This will be multicentre a phase II randomized controlled and open-label trial. It will compare the 6-months objective response (CR+PR) rates obtained with Drug Eluting Bead Trans-Arterial Chemo-Embolization (DEB-TACE) alone versus DEB-TACE followed by Stereotactic Ablative Radiotherapy (SABR) in patients with hepatocarcinoma stage BCLC B.

This trial will also include one substudy. This substudy will confront the immuno-histochemical results collected on tumoral biopsies to the biological and imaging (MRI) results. Every patient participating to the trial can also participate to this substudy.

The patients will be randomized in 2 arms determining the treatment they will receive:

Arm A: actual standard treatment = TACE Arm B: experimental arm = TACE + SABR

Eligibility Criteria:
Inclusion Criteria:

* Hepatocellular carcinoma larger than 3 cm and non-resectable, with a diagnosis established either by:

  * dynamic imaging (non-invasively), showing a typical contrast enhancement and wash-out
  * histopathology
* satellite lesions are allowed (at most three lesions) as long as the doses constraints are still achievable
* Hepatocellular carcinoma belonging to Barcelona Clinic Liver Cancer Stage System class B
* Tumor must be measurable on a multi-phase MRI according to mRECIST criteria
* Non-tumoral liver volume ≥ 800 cc
* Child-Pugh (CP) A to B7 cirrhosis
* HCC Patients can be included if they require treatment prior to liver transplantation
* ECOG performance status 0-1
* AST/ALT \< 5 times ULN
* Initial platelets ≥ 50 000 x 10E9/l, neutrophils \> 1500 x 10E9/l, Hb \> 9 g/dl
* Serum creatinine \< 1.5 X normal, or calculated Creatinine clearance rate ≥ 60 mL/min
* As tumor biopsy can be performed after inclusion, pure hepatocellular carcinoma but also mixed hepatocellular carcinoma will be allowed in this trial. Cholangiocarcinoma cannot be included.
* Written informed consent form to be signed,
* Patient willing and able to comply to the follow-up schedule
* Patients in fertile age should use a contraceptive method during treatment and 4 months after.

Exclusion Criteria:

* Eligibility for resection or ablative treatments
* Extra hepatic spread of the disease
* Previous treatment of the same lesion with TACE
* Previous treatment with selective internal radiotherapy or radiotherapy to the upper abdomen
* Uncontrolled Ascites
* Uncontrolled Encephalopathy
* Any clinical sign of acute viral or non-viral hepatitis (new serological testing are not required)
* Known current pregnancy
* Uncontrolled active co-morbidity
Improving Perception of Speech in Noise in Children With Communication Disorders

Smarty Ears has developed a prototype of an innovative therapeutic training system to improve speech perception in noise by training children on interrupted noise (which has silent intervals that allow for fragments of the target to be heard). The study will attempt to validate the technology and gather initial design feedback from clinicians and caregivers and from children with ASD and HL.

Recent evidence indicates that listening in interrupted noise can provide perceptual benefits, such as remapping the auditory environment and learning to use acoustic cues. The developed technology, uses adaptive listening training that automatically increases noise level difficulty as performance improves, and includes age appropriate rewards to maintain interest. The mobile app includes an initial and final screening, a training system that administers training via the child's own mobile device, and detailed performance dashboard. The study will attempt to validate the technology by gathering feedback from clinicians and caregivers and from children with ASD and HL.

Eligibility Criteria:
Inclusion Criteria:

* For all children: normal or corrected to normal vision.
* For children with typical development normal or corrected to normal vision + normal hearing.
* For children with HL Children must have at least one year experience with amplification (i.e Hearing aids) and no threshold\> 70 dB.

Exclusion Criteria:

* To participate, all children must be able to comply with directions and engage in tasks that require some expressive language response on the language and cognitive measures (i.e. children who are considered to be in the "word combinations" or "sentences expressive language" phase; Tager-Flusberg et al., 2009).
Variable Effects of Anti-diabetics on Stress Hyperglycemia Ratio

A blood glucose level of equal to or greater than 180 mg/dL that occurred during stress in a patient without diabetes mellitus (DM) is termed stress hyperglycemia (SH). The stress hyperglycemia ratio (SHR) is defined as the fasting blood glucose divided by the blood glucose level that is calculated from the glycosylated hemoglobin (HBA1c) value on admission. A significantly higher SHR is associated with worse prognostic biomarkers in diabetic patients with complications

Stress hyperglycemia (SH) is an increase in circulating glucose levels in biological fluids as a physiological response to stress in diabetic patients who are known or newly diagnosed, or a pathological condition associated with in-hospital-related hyperglycemia.

Interventions. Through their pleiotropic effects, some oral hypoglycemic agents improved stress hyperglycemia. When compared to non-SGLT-I (sodium glucose transporter-inhibitor) users, diabetic patients who used (SGLT-I) and had an acute myocardial infarction had less prevalent stress hyperglycemia, a smaller infarct size, and evidence of a low inflammatory response. The rationale this study is to evaluate the SHR in T2D patients who do not have serious illnesses and are managed with oral hypoglycemic agents

Eligibility Criteria:
Inclusion Criteria:

* Age ≥35 years
* Diagnosis of Type 2 diabetes
* Absence of serious illnesses
* No evidence of trauma

Exclusion Criteria:

* Overt complications of diabetes
* Any participant used antibiotics for infectious diseases
* Any participant used non-steroidal antiinflammatory drugs
* Current or past history of mental diseases
* Current hematological diseases
* Pregnancy
* Nursing mothers
An Early Warning Model for Assessing the Onset, Progression and Sequelae of COVID-19

Based on the characteristics of symptoms, differences in physical and chemical examinations and tests, and characteristics of traditional Chinese medicine (TCM) disease differentiation and syndrome differentiation, the evaluation indicators for the clinical early warning model were screened, and the "three-level early warning mechanism for COVID-19 patients at high risks, with progression to severe cases and sequelae was constructed.

Adopt multi-level evidence base architecture, build "multi-source data analysis, feature extraction, multi-level evidence extraction, active The integrated Chinese and Western medicine big data platform integrates the original evidence processing into a multi-level evidence base, comprehensive analysis of The platform will generate a multi-level evidence base by processing the original evidence, analyze the evaluation indexes of New Coronary Pneumonia, select the features, build a deep neural network model, train and validate the model, and establish a high The model is trained and validated, and a three-level early warning model is established for people at high risk of new coronary pneumonia, those who turn serious, and those with sequelae.

Eligibility Criteria:
Inclusion Criteria:

1. Meeting the diagnostic criteria of mild and moderate types of COVID-19 disease described in the "Diagnostic and Treatment Protocol for Novel Coronavirus Pneumonia (Trial version 9)" \[9\];
2. Age ≥18 years old and ≤90years old;
3. Not more than 5 days after the occurrence of the first symptom (or confirmed onset);
4. The subject agrees to participate the study and have signed the informed consent form by paper signature, electronic signature of mobile software or voice authorization.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Patients complicated with severe heart, liver, kidney, blood system and other primary diseases and mental disorders.
3. Patients with disturbance of consciousness, aphasia, dementia and other conditions that prevent them from cooperating with the clinical investigators
4. Patients with incomplete study data.
Two-session Catheter-directed Sclerotherapy Using Ethanol for Endometrioma

The goal of this clinical trial is to evaluate the safety and clinical outcomes of two-session catheter-directed sclerotherapy (CDS) with 96% ethanol in patients with endometrioma. The main question it aims to answer is:

• Is two-session CDS with 96% ethanol safe and effective for treating endometrioma?

Participants will:

* Receive the first session CDS for endometrioma
* Carry the catheter overnight and be monitored in the patient ward
* Receive the second session CDS the next day

Catheter-directed sclerotherapy has been reported as an effective treatment for endometrioma. However, whether the sclerosing agent should be retained inside the endometrioma was controversial. To increase the contact between the sclerosing agent and the endometrioma wall, two-session catheter-directed sclerotherapy using 96% ethanol was attempted, and safety and clinical outcomes were assessed in patients with endometrioma.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years
* Symptom manifestation as endometriosis (i.e., dysmenorrhea, dyspareunia, and lower abdominal or pelvic pain)
* Endometrioma ≥ 3 cm confirmed on ultrasound
* No evidence of solid lesions on ultrasound
* No suspected extraovarian endometriosis

Exclusion Criteria:

* History of gynecologic malignancy
* Active inflammation or infection
* Abnormal coagulation profile
* Loss to follow-up
Retrospective and Prospective Disease Progression and Quality of Life in XLH

There is limited empirical data documenting disease progression and impact on quality of life for patients with X-linked hypophosphatemia (XLH). This study seeks to investigate the impact of XLH in adults living in the UK retrospectively and prospectively over a 12 month period, using qualitative interviews, SEIQoL-DW, EQ-5D-5L, SF36 quality of life tools.

XLH is a rare, genetic, chronically debilitating and deforming condition (www.nice.org.uk/guidance/HST8). XLH is characterised by renal phosphate wasting, hypophosphatemia and defective bone mineralisation. The incidence of XLH is reported to be between 1:20,000 and 1:25,000 live births. In the UK, it is estimated that there are around 250 paediatric XLH patients and around 2,500 adult XLH patients (Delmestri,et al \[Unpublished report\]2018). The clinical phenotype of XLH is varied amongst patients, even among affected members of the same family. This can range from no signs or symptoms, slow growth in children, short stature, bone abnormalities that can affect movement and result in pain, bowed legs and knocked knees (where lower legs are positioned at an outward angle), tooth abscesses and excessive dental caries and hearing loss (adult patients only).

This study will recruit 36 adults living with XLH, who are aged 28 years or over and living in the UK. The study will be advertised by the Sponsor and funder Medialis Ltd and via the patient organisation Metabolic Support UK. All study activities will take place via tele-visits and online questionnaires. The study will last approximately 2 years, allowing for one-year recruitment and a further 12 months to conduct all study visits.


Eligibility Criteria:
Inclusion Criteria:

* • Participant has a diagnosis of XLH

  * Participant is aged 28 years and above.
  * Participant is capable of providing informed consent
  * Participant is able to read and converse in English
  * Participant is able to comply with the study schedule (5 tele-visits over a 12-month period)

Exclusion Criteria:

* • Participant does not have a diagnosis of XLH

  * Participant is aged under 28 years
  * Participant is not capable of giving informed consent
  * Participant is unable to read and converse in English
  * Participant is unable to comply the with study schedule (5 tele-visits over a 12-month period)
Efficacy of Topical Lidocaine to Decrease Discomfort With Intranasal Midazolam Administration

The purpose of this study was to establish whether premedication with topical lidocaine would reduce the pain associated with IN midazolam administration in children. The study was designed to be a double-blinded, randomized, placebo-controlled trial performed in an urban, academic pediatric emergency department.

This was a double-blinded, randomized, placebo-controlled trial performed in an urban, academic pediatric emergency department with an annual census of 67,000 patients. Children 6-12 years old for whom IN midazolam was ordered were eligible for enrollment. Patients were randomly assigned an identical intranasal medication (4% Lidocaine or 0.9% saline). Patients were administered the study drug followed by IN midazolam. Patients then assigned a pain score for midazolam administration using the Wong-Baker FACES Pain Rating scale. The primary endpoint of pain score was analyzed with a two-tailed Mann-Whitney U test, with P \< 0.05 considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Ages 6-12
* Previously healthy
* Attending physician concludes that the patient would benefit from administration of an anxiolysis medication prior to a minor procedure

Exclusion Criteria:

* Moderate to severe asthma or other chronic lung disease
* Co-morbid conditions including cerebral palsy, developmental delay, or other chronic illness deemed by the Attending physician to be unsafe to receive anxiolysis with Versed.
* Any child presenting with a life-threatening condition.
Investigation of Maintaining Visual Performance Achieved With Cyclosporine Therapy

This study will evaluate the safety and efficacy of cyclosporine 0.05% ophthalmic emulsion (Restasis®) in patients with dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* History of dry eye in both eyes
* Willing to use eye drops for dry eye symptoms

Exclusion Criteria:

* Anticipate wearing contact lenses during the study
* Laser-assisted in situ keratomileusis (LASIK) surgery within the past 12 months
* Any ocular and/or lid surgeries within the past 6 months
* Cataract surgery in either eye
* Current or anticipated use of temporary punctal plugs during the study
Development of a New Electronic Measure of Pediatric Pain: A Pilot Study

The purpose of this study is to test the accuracy of a computer-based program to self-report the location and intensity of a child's pain in comparison to a traditional self-report paper and pencil measure and physician physical exam. Using a computer to assess pediatric pain may offer many advantages and improvements in how pediatric pain is diagnosed and treated.

Approximately 1 in 4 children aged 5-18 report experiencing pain. As many as 2 in 3 of these children will develop a significant physical, emotional, social or academic impairment. Recent research has identified pediatric pain as an area where biological, psychological and social treatments can interact to provide substantial changes in pain symptoms. However, there is a lamentable dearth of empirical studies evaluating the efficacy of treatments for chronic pain in children. These findings necessitate more intensive efforts to improve methods on initial assessment and treatment, but an important first step is to improve the sensitivity of outcome evaluation.

Existing measures of pediatric pain have been concerned with symptom intensity and the general locus of pain. Children are traditionally asked to mark with a number or a color the region in which they experience pain. This is helpful for understanding generality that a large area such as the head, joints, or stomach hurts. However, it does not allow the child the option to specify a narrow area of discomfort within a broader region (e.g., upper right quadrant of the stomach). Consequently, current pain instruments may lead to an inaccurate or imprecise understanding of a child's pain, which can adversely impact clinical care of the quality of clinical trials.

The current study will compare a widely used paper-based "pain mapping" tool to a new electronic tool designed by study investigators to capture the same information as the paper measure, while adding more precision regarding pain regions and greater range in terms of pain intensity. We expect that children's responses on these two measures (pencil/paper and electronic) will be generally similar, but we expect that the electronic measure will map more closely onto the Attending Physician's notes regarding discrete pain location, intensity, and/or diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Presentation to either APC Clinic or IPM Clinic.
* Child participant is 8-17 years of age.

Exclusion Criteria:

* Child/parent not English speaking.
* Child unable to see computer screen or interact with the keyboard or mouse.
* Parent/child unable or unwilling to provide permission/assent.
Impact of Air Pollution on Chronic Respiratory Diseases

The aim of this study is to evaluate the impact of air pollution on the occurrence and clinical course of chronic respiratory diseases, and discover new biomarkers from various devices such as CT images that can indicate the process and amount of lung damage caused by air pollution.

Accordingly, the investigators have designed an prospective cohort with enrollment of normal people and patients with chronic respiratory diseases of three different categories (chronic obstructive pulmonary disease, asthma, idiopathic pulmonary fibrosis). Participants will be followed up for a period of one year, with evaluation of the clinical course of the respiratory disease and exposure to air pollution.

Normal people (n=90) and patients with chronic respiratory diseases (chronic obstructive pulmonary disease, asthma, idiopathic pulmonary fibrosis, n=90 for each disease) will be enrolled at 5 different institutions in South Korea and followed up for one year. Inspiratory-expiratory CTs and tests including physical examination and blood/urine tests would be performed at the time of enrollment and the time at completion of the follow up period for each participant. Participants would be checked for the residency and working places, as well as checked for the amount of air pollution exposure using a wearable measurement device for 5 days during the study period ( time at enrollment / 3 months / 6 months / 9 months / time at completion). The device would cause no effect on usual daily life or the medical status of the participant. The clinical course such as occurrence of disease, acute exacerbation, decline of lung function, imaging status, mortality would be evaluated as well as the exposure of air pollution for each individual.

Eligibility Criteria:
Inclusion Criteria:

* Normal: People with no lung lesions in chest X-ray and St. George's Respiratory Questionnaire score \<25, and post bronchodilator FEV1/FVC (forced expiratory volume at one second/forced vital capacity) \>= 0.7 and FEV1 \>= 80% and FVC \>= 80%.
* Chronic obstructive pulmonary disease: Patients with over 10 pack-years of smoking history and post bronchodilator FEV1/FVC \<0.7 and FEV1 \< 80%, and no other reason for decline of lung function.
* Asthma: Patients with FEV1/FVC \< 0.85 and increase in over 12% and 200mL of FEV1 by bronchodilator inhalation. Patients with P20 \< 16mg/dL by bronchial provocation test.
* Idiopathic pulmonary fibrosis: Shows usual interstitial pneumonia according to chest CT and has no other reasons such as systematic diseases or medication history.

Exclusion Criteria:

* Subjects who refused for enrollment in the study
* Subjects who experienced an acute exacerbation within 1 month.
* Subjects under age of 19.
Transplacental Transmission of COVID-19

SARS-CoV-2, the agent responsible for pandemic COVID-19 infection, is transmitted mainly by respiratory droplets. Regarding maternal-fetal transmission, even if the mode of transmission from mother to fetus is not clear, some cases of perinatal transmission have been described, but without certainty on the routes of placental contamination, trans-cervical or by environmental exposure. .

The case described by J. Vivanti of a newborn with neonatal neurological involvement and whose mother had been infected during the last trimester of pregnancy reports possible transplacental transmission in a context of positive and elevated viremia in the mother and positive viremia in the newborn.

In 2021, it becomes essential to clarify if and how SARS-COV-2 reaches the fetus, in order to prevent neonatal infection, optimize pregnancy management and better understand the pathogenesis of COVID-19.

SARS-COV-2, ACE2 and TMPRSS2 co-receptors are highly expressed in placental tissues and may be actively involved in transplacental transmission of the virus. From a case of materno-fetal transmission described by our team (publication in progress), we observed placental expression of the Spike SARS-COV-2 protein, but also of the ACE2 receptors, TMPRSS2 and cathepsin L. Cytotrophoblast and syncytiotrophoblast cell stains were positive within the placental villi. Maternal leukocytes were also labeled for these proteins.

Eligibility Criteria:
Inclusion Criteria:

* Social security affiliation
* Signed informed consent
* Pregnant woman with proven SARS-COV-2 infection during full-term delivery

Exclusion Criteria:

* Patient vaccinated within 15 days prior to inclusion