cyrilzakka/clinical-trials huggingface dataset:
Ambient Digital Scribes Populating Clinical Notes

The purpose of this study is to assess the impact of Ambient Digital Scribes that will automatically record clinical encounters and use AI technology to populate clinical notes. The investigators expect that when clinicians do not need to either write notes during the clinical encounter and can instead face patients when talking, several effects could result, including 1) patients report higher satisfaction with the visit 2) clinicians report less burnout, and 3) clinician-patient communication includes more evidence-based tools that indicate high quality communication.

Effective communication forms the foundation of high-quality care. Communication includes verbal and nonverbal channels, with nonverbal communication playing a large role in acknowledging and responding to patient concerns. Effective communication has been negatively affected by the introduction of the electronic health record and required documentation. Clinicians often attend to the computer, writing notes during the encounter, which can lead to missing emotional cues from patients. Missing this key information can leave patients feeling dismissed, not heard, and can lead to lower comprehension and adherence. Further, the amount clinicians need to document often cannot occur solely in the encounter, leading to clinicians working after hours to finish their notes. The cumulative effect of the change in communication and required documentation has been a strong predictor of burnout among clinicians.

The introduction of AI into healthcare might have a positive impact on both efficiency and communication, thus resulting in higher clinician and patient satisfaction. With the advent of Ambient Digital Scribes and AI potentially populating notes, clinicians can have the opportunity to attend fully to patients both verbally and nonverbally. Patients likely will feel more heard, valued, and can ask questions, leading to higher comprehension and adherence. Clinicians might feel the burden of documentation lifted, might be more efficient, and feel more satisfied by providing the care they desire.

To test the impact of Ambient Digital Scribes, the investigators propose a sub-study to the approved project (Pro00115827) where the investigators will audio record clinicians in usual care before they are assigned to the two different scribing programs. The investigators will assess patient outcomes, namely perceived empathy and patient satisfaction, and clinician burnout. The investigators also will code audio recorded encounters to assess: 1) reflective statements (showing active listening), 2) empathic responses to empathic opportunities, 3) patient question-asking, and 4) length of encounter.

Eligibility Criteria:
Patient Inclusion Criteria:

* 18 years or older
* able to speak and read English

Patient Exclusion Criteria:

* unable to speak and read English

Clinician Inclusion Criteria:

* delivering care in a clinic in which Ambient Digital Scribes are being employed

Clinician Exclusion Criteria:

* not delivering care in a clinic in which Ambient Digital Scribes are being employed
Randomized Clincal Trial on the Effect of a Restricted Gluten Contamination Elimination Diet Among Celiacs [GluCED]

The study assessed whether compete healing of duodenal mucosa in celiac patients with persistent Marsh I-II lesion after 1 year of gluten free diet (GFD):

* could be achieved by adoption of a diet based exclusively on naturally gluten free products, with the elimination of commercially available processed food (GCED, Gluten Contamination Elimination Diet);
* may depend upon time of exposure to GFD.

Investigators studied two cohorts of celiac patients, both on GFD, for at least one year:

* cohort A: patients re-biopsied after three months on GCED;
* cohort B: patients re-biopsied after a minimum of further two years on standard GFD.

Despite strict adherence to gluten free diet (GFD), the complete healing of the duodenal mucosa of celiac patients is rarely achieved. The cause of the persistence of the inflammation is not yet understood.

It is well known that there is a high degree of variability in individual response to gluten with some patients worsening of duodenal histology upon exposure to very small amount of gluten.

This observation suggest that contamination with gluten of commercially available processed food and/or small amount of gluten in processed foods labeled "gluten-free" (less than 20 ppm) may prevent complete mucosal healing.

This explanation is indirectly supported by a study of Hollon et al. (2013) showing that persistence of gastrointestinal symptoms in celiac patients on a GFD is abolished, in 85% of cases, by the adoption of a diet based exclusively on naturally gluten-free products, and on the elimination from the diet of commercially available processed food and products labeled "gluten free " (Gluten Contamination Elimination Diet, GCED).

The main aim of this study was to assess whether the complete healing of duodenal mucosa in patients with persistent Mars I-II lesions after 1 year on GFD i) could be achieved, as a proof of the concept, by the adoption of a GCED OR ii) may depend upon time of exposure to GFD. To achieve this aim investigators studied 2 cohorts of patients with Marsh I-II lesion after 1 year on GFD: cohort A re-byopsied after 3 month GCED , and cohort B re-biopsied after a minimum of further 2 years on standard GFD.

Eligibility Criteria:
Inclusion Criteria:

* Marsh I-II lesion at 12-18 months after starting GFD
* Negative Celiac Disease serology
* Strict adherence to gluten free diet without digression

Exclusion Criteria:

* presence of Gastrointestinal Symtoms
* presence of Helicobacter pylori infection
Spectacle Lens Visual Acuity Assessments Study

This is a two-arm parallel group, non-dispensing study. Participants will be existing active CYPRESS Extension (CPRO-1802-002) subjects. Subjects will undergo additional visual performance assessments.


Eligibility Criteria:
Inclusion Criteria:

* Existing subject from the CYPRESS Extension study (CPRO-1802-002)
* Ability to comply with study assessments
* The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed coy of the form

Exclusion Criteria:

* Any current ocular infection, inflammation or irritation likely to affect vision
Effects of Expert Arbitration on Clinical Outcomes When Disputes Over Diagnosis Arise Between Physicians and Their Artificial Intelligence Counterparts: a Randomized, Multicenter Trial in Pediatric Outpatients

We have recently developed an artificial intelligence (AI) framework to diagnose common pediatric diseases. This randomized controlled clinical trial aims to investigate the effects of expert arbitration on clinical outcomes in the situation where the AI-based diagnosis differs from the diagnosis made by pediatricians.

Based on the historical clinical data of more than 1 million pediatric outpatients in the Guangzhou Women and Children's Medical Center, an AI diagnostic framework has recently been developed for common pediatric diseases \[Liang H et al. evaluation and accurate diagnosis of pediatric disease using artificial intelligence. Nat Med. 2019;25(3):433-8\]. This AI framework utilizes predefined schema to extract informative clinical data from free text and reaches clinical diagnoses by hypothetico-deductive reasoning. In internal validation, the AI system showed accuracy rates ranging from 0.85 for gastrointestinal disease to 0.98 for neuropsychiatric disorders, suggesting that it might be a promising assisting diagnostic tool in clinical practice. However, there is a lack of evidence-based strategy on how to handle the scenarios where the AI-based diagnosis and the diagnosis made by pediatricians are discordant. It is legitimate to assume that diseases with discordant diagnoses present more similar clinical features; in this case it is necessary to introduce an extra arbitrator for differential and decisive diagnosis. Therefore, we conduct this randomized controlled trial to: 1) compare the accuracy of the two diagnostic modes in a real-world clinical setting where the AI-based diagnosis and the diagnosis made by pediatricians are discordant by introducing an expert arbitrator; and 2) look further into the change of clinical outcomes (hospital revisit and hospitalization in the next 3 months after initial visit; average total outpatient cost) due to introduction of the expert arbitrator. Please note that although the aforementioned AI framework was designed for diagnosis of a wide range of diseases, this clinical trial is limited to outpatients encountered in three specialty clinics, i.e. respirology, gastroenterology, and genito-urology. The reason for this selection is that the discordant diagnoses are assumed to be more common for these two specialties according to the internal validation result.

Eligibility Criteria:
Inclusion Criteria:

1. Outpatients who visits the respirology clinics or the gastroenterology clinics during the recruitment period.
2. Written informed consent is provided by parents/guardians

Exclusion Criteria:

1. Patients with any conditions that require immediate diagnosis and treatment.
Clinical Efficacy and Safety of Using 3.0mg Liraglutide to Treat Weight Regain After Roux-en-Y Gastric Bypass Surgery

This is a randomized, double-blinded, placebo-controlled trial of liraglutide versus placebo over a follow-up period of 12 months in patients at least 18 months following Roux-en-Y gastric bypass (RYGB) who are experiencing weight regain. This study will assess the efficacy of liraglutide in improving cardiometabolic risk profile (as indicated by serum lipids, HbA1c, and waist circumference) and quality of life (as assessed by PHQ-9 (Patient Health Questionnaire), versus placebo in patients at least 18 months following RYGB who are experiencing weight regain as well as the safety of liraglutide in this patient population.

The specific aims of this study are to:

* To evaluate the effects of liraglutide on body weight loss in patients who are experiencing weight regain following RYGB.
* To evaluate the effects of liraglutide on cardiometabolic risk and quality of life in patients who are experiencing weight regain following RYGB.
* To evaluate the safety of liraglutide in post-RYGB subjects.
* To evaluate the changes in obesity-related comorbid conditions in patients who are experiencing weight regain following RYGB.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 months status-post RYGB
* BMI 27 kg/m2 or greater in the presence of at least one weight-related comorbid condition
* BMI 30 kg/m2 or greater
* Regain of ≥10% of maximum TBWL post-RYGB
* Ability to provide informed consent before any trial-related activities
* Express willingness to follow protocol requirements

Exclusion Criteria:

* Pregnancy at time of enrollment
* Intention of becoming pregnant or breast feeding in the next 12 months
* Females of childbearing potential who are not using adequate contraceptive methods
* Presence of acute psychiatric problems or immaturity which would compromise cooperation with the study protocol
* Presence of biliary disease
* Known or suspected allergy to liraglutide or any product components
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
* History of pancreatitis
* History of alcoholism
* History of Type 1 DM (Diabetes Mellitus)
* History of previous bariatric surgery other than RYGB except h/o LAGB and band removal.
* \>10 years status-post RYGB
* \< 25% TBWL at post-RYGB weight nadir
* \>50% post-operative TBWL at time of screening
* Simultaneous use of any weight loss medications
* Use of insulin at the time of enrollment
* Current use of any GLP-1 agonist medication
* History of taking any GLP-1 agonist medication
* Participation in another ongoing clinical study
* Conditions that, in the opinion of the principal investigator, may jeopardize the patient's well-being and/or the soundness of this clinical study
Effectiveness of Bubble Nasal Continuous Positive Airway Pressure (bCPAP) in Neonatal Respiratory Distress

The objective of study is to determine the effectiveness of bubble Continuous Positive Airway Pressure (bCPAP) in neonates presenting with respiratory distress as compared to the control group ( using oxygen via nasal cannula). The effectiveness will be calculated in terms of reduction in Silverman Anderson Retraction Score.

After approval from the IRB of King Edward Medical University, and taking informed consent from parents of the participants, total of 120 neonates fulfilling inclusion and exclusion criteria will be enrolled and randomly allocated in two groups; group A and group B. All demographic details of participants in both groups be collected. In group A, neonates will be given bCPAP for respiratory support while neonates in group B, will be given nasal oxygen as control group. Neonates in both groups will be followed for 48 hours. The effectiveness will be determined by the reduction in Silverman Anderson Retraction Score (SARS) up to or less than 3, at the end of 48 hours. Data will be collected and analysed.

Eligibility Criteria:
Inclusion Criteria:

* Patients having age 28 days of life or younger (Neonates)
* Gender- both male and female
* Gestational ages ≥32 weeks
* Having respiratory distress (as per the operational definition- respiratory rate \>60/min plus any of the following features: grunting, subcostal/intercostal retractions, nasal flaring, inability to maintain spO2 \>90% at room air)
* Silverman Anderson Retraction Score ≥4

Exclusion Criteria:

* Neonates having gestational age less than 32 weeks
* Birth weight less than 1.5 kg
* Neonates having congenital malformations, air leak syndromes, hypoxic ischemic encephalopathy
* Neonates requiring mechanical ventilation at the time of admission
JAK-i on RA B-lymphocytes Tolerance and Disease Resolution Through JAK Signaling In Rheumatoid Arthritis

The study will reveal the transcriptomic signature linked to the aberrant activation of B lymphocytes in RA identifying novel molecular potential targets for inflammation resolution and immune tolerance promotion. The combination with B lymphocytes phenotyping will dissect the impact of the identified genes on B lymphocyte maturation and activation in RA. Moreover, in vitro study on B lymphocyte cultures using selective JAK1 inhibition will reveal, at deeper level, its transcriptomic effect on RA B lymphocytes activation profile and phenotype, providing the discovery of new biomarkers of the loss of immunological tolerance, active disease and long lasting disease remission.


Eligibility Criteria:
Inclusion Criteria:

1. Signed Written Informed Consent. Before any study procedures are performed,subjects will have the details of the study described to them, and they will be given a written informed consent document to read. Then, if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of trained study personnel.
2. Patients fulfilling classification criteria for Rheumatoid Arthritis (2010 ACR/EULARclassification criteria)
3. Age: 18-70 years
4. For preclinical cohort: Individuals with positivity for ACPA or IgM/IgA RF without clinical signs of arthritis, whose positivity is not related to other concomitant pathologic conditions.
5. For naive to treatment cohort: RA patients without previous exposure to conventional DMARDs or biologic/targeted synthetic-DMARDs.
6. For resistant to treatment cohort: RA patients with failure to previous conventionalDMARDs for inadequate response or side effects.
7. For remission RA cohort: RA patients in sustained clinical and ultrasound remission as stated in section 3.3.1.
8. For healthy control cohort: Healthy donors will be aged from 18 to 70 years.

Exclusion Criteria:

1. Severe and uncontrolled infections such as sepsis and opportunistic infections.
2. Patients who are currently included in any interventional clinical trial in RA.
3. RA patients in therapy with other biologics.
4. Healthy donors receiving anti-inflammatory drugs
Comparison of Clomid and Lezra with Lezra for Ovulation Induction in Clomid Resistant PCOS Case

Clomiphene citrate resistant i.e failure to ovulate after 6 cycles of ovulation induction effects 15-40% of patients with PCOS.Two treatment groups will be formed one recieving letrozole alone and another recieving CC and letrozole combined.Mature follicles and endometrial thickness will be checked by transvaginal ultrasound and results will be recorded.

Subfertility is characterized by the inability to achieve conception despite engaging in regular unprotected sexual intercourse for 1-2 years.PCOS exhibits chacteristic traits such as obesity,heightened insulin resistance accompanied by compensatory hyperinsulinemia,oligo/anovulation and subfertility.Clompiphene citrate induces ovarian stimulation.Letrozole ,an aromatase inhibitor emerges as a novel medication with comparable efficacy to CC as a first line treatment for inducing ovulation in cases of anovulation.

Eligibility Criteria:
Inclusion Criteria:

* women of 20-40 years with a history of PCOS and resistant to CC

Exclusion Criteria:

* Premature ovarian insufficiency
* Husband has oligo azoospermia
* Hypothyroidism
* Hyperprolactinemia
Implementation of Rehabilitation Program for Post COVID-19

Many people who have suffered from the effects of this disease might now be at risk of long-term impairment and disability. The extent of this impairment and disability is yet unknown, but it is clear from early research that these patients will be in need of rehabilitation in all phases of the disease - acute, post-acute and long-term.

Rehabilitation is defined as "a set of interventions designed to reduce disability and optimize functioning in individuals with health conditions in interaction with their environment." Rehabilitation might very well be a key strategy to reduce the impact of COVID-19 on the health and function of people.

A team work is needed to implement this programs which are essential in all phases to facilitate early discharge, but even more to support and empower patients.


Eligibility Criteria:
Inclusion Criteria:

* Post acute COVID-19 patients

Exclusion Criteria:

* Acute COVID-10
* Non- COVID-19 patients
* Recent myocardial infarction
* Recent pulmonary embolism
* Neurologic diseases
Effect of Liraglutide on Absorption of Paracetamol in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to to investigate if there is a drug-drug interaction between liraglutide and paracetamol (Benuron®) and to investigate the effect of liraglutide on post prandial glucose.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Diet-treated subjects with type 2 diabetes with HbA1c 7.5-9.5 %
* Subjects with type 2 diabetes in oral anti-diabetic drug (OAD) monotherapy treated with metformin or alpha-glucosidase inhibitors with HbA1c 7.0-9.5%
* Body mass index (BMI) 18.5-40 kg/m\^2
* Subjects should have a stable body weight for at least 3 months prior to screening (as judged by the Investigator)

Exclusion Criteria:

* Impaired liver function
* Impaired renal function
* Clinically significant active cardiovascular disease including history of myocardial infarction within the last 6 months and/or heart failure
* Any clinically significant abnormal ECG (electrocardiogram)
* Uncontrolled treated/untreated hypertension
* Recurrent severe hypoglycaemia as judged by the Investigator
* Active hepatitis B and/or active hepatitis C
* Positive human immunodeficiency virus (HIV) antibodies
* Known or suspected allergy to trial product(s) or related products
Inulin and the Gut Microbiota in Healthy Adults

In this study the effects of a fibre dietary supplement on the gut microbiome in healthy adults will be investigated. For this purpose, a 14-day dietary supplementation with inulin or placebo (maltodextrin) will be carried out in healthy adults. The main objective of the study is to investigate inulin-induced changes in gut bacterial composition, bacterial gene expression, bacterial metabolite production and associated immune system changes.

Healthy volunteers between the age of 18 and 60 will be recruited. In the first week of the study baseline blood and stool sampleswill be collected and nutritional information recorded. The participants will then take 15g of inulin or maltodextrin twice per day for 14 consequetive days. Blood and stool samples will be collected daily during the inital phase of the intervention and again at the end of the intervention.

From the stool samples bacterial nucleic acids will be isolated and used for metagenomic and transcriptomic analysis. The blood samples will be used to analyse for markers of barriere function and for analysis of immune cells.

Eligibility Criteria:
Inclusion Criteria:

* Men and women in a 1:1 ratio
* Age 20 - 60 years
* Body Mass Index 18.5 - 34.9 kg/m2

Exclusion Criteria:

* Arterial hypertension, diabetes mellitus, known cardiovascular disease requiring treatment (e.g. coronary heart disease, stroke).
* Known end-organ damage to the brain, heart or kidneys
* Chronic kidney disease, need for dialysis
* Diseases or functional disorders that, in the opinion of the study doctor, preclude participation in the study
* Acute infections
* Malnutrition
* Antibiotics in the previous 4 weeks
* Regular consumption of probiotics or prebiotics
* Allergies
* Change in bodyweight of more than 2 kg in the previous 3 months
* Inability to uderstand the studie aims and study procedures
* Drug or alcohol abuse
Dose-escalation Study of Safety of PBCAR19B in Participants With CD19-expressing Malignancies

This is a Phase 1, nonrandomized, open-label, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR19B in adult study participants with CD-19 expressing malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory CD19+ expressing malignancies
* At least 2 prior regimens per Standard of Care

Exclusion Criteria:

* No history of active CNS involvement
Complementary Weaning With Adult Food Typical of the Mediterranean Diet

A Randomized Controlled Clinical Trials was conducted to study the medium-long term impact of a complementary weaning using adult foods typical of Mediterranean Diets (MD) on children taste development and eating habits, and on the microbiota composition.

Main objectives were to assess the effect of such weaning scheme on:

1. medium-long term adherence of the children to the MD (Primary aim).
2. familial eating habits to verify how many changes may come from an early education of the kid toward a Mediterranean eating style
3. the BMI of the children
4. gut microbiota composition


Eligibility Criteria:
Inclusion Criteria:

* Infants, either breast fed or formula fed between 4 and 6 months of age
* Informed consent from at least one parent

Exclusion Criteria:

* Infants either with associated comorbidities or with low birth weight