cyrilzakka/clinical-trials huggingface dataset:
Validation of an Artificial Intelligence-based Algorithm for Skeletal Age Assessment

The purpose of this study is to understand the effects of using an Artificial Intelligence algorithm for skeletal age estimation as a computer-aided diagnosis (CADx) system. In this prospective real-time study, the investigators will send de-identified hand radiographs to the Artificial Intelligence algorithm and surface the output of this algorithm to the radiologist, who will incorporate this information with their normal workflows to make an estimation of the bone age. All radiologists involved in the study will be trained to recognize the surfaced prediction to be the output of the Artificial Intelligence algorithm. The radiologists' diagnosis will be final and considered independent to the output of the algorithm.

The investigators are targeting to study the effect of their Artificial Intelligence algorithm on the radiologists' estimation of skeletal age. Currently, radiologists make the estimation using only the radiographic images and health records. As part of this study, the radiologists will estimate skeletal age from radiographic images, health records, and the output of the CADx algorithm. The investigators wish to understand how radiologists using the Artificial Intelligence algorithm compare to radiologists who do not for the specific task of estimating skeletal age.

This study is organized as a multi-institutional randomized control trial with two arms - experiment (receiving the Artificial Intelligence algorithm's output) and control (no intervention). Both of these arms will be compared to a clinical reference standard ("gold standard") composed of a panel of radiologists. The metric of comparison will be Mean Absolute Distance (MAD). The investigators plan to use statistical tests such as the t-test to determine any statistically-significant difference in skeletal age estimation between the two groups.

The investigators have recruited and analyzed data from a sample size of 1600 exams. Patients getting these exams will not undergo any research procedures that deviate from the current standard practices.

Eligibility Criteria:
Exams that meet the following inclusion criteria will be included: (1) exams read by radiologists who interpret pediatric skeletal age exams and verbally consent to participate (2) exams that contain a procedure code or study description indicative of a skeletal age exam.

Exams containing more than one radiograph will not be included. Exams for which a trainee provides a preliminary interpretation will be excluded. No further exclusion criteria will be applied on the basis of image quality metrics or manufacturers. No exclusion criteria will be applied on the basis of patient chronological age.
Virtual Reality, Pain, Clinical Outcomes, Hydrotherapy, Children, Burn

This study aims to evaluate the effect of virtual reality on pain and clinical outcomes during hydrotherapy for children with burn.


Eligibility Criteria:
Inclusion Criteria:

* Aged from 3-6 years.
* Children who do not have a burned face.
* Undergoing hydrotherapy procedure for wound care.
* Able to score their own pain, with or without a visual tool.
* Willing to participate in the study.

Exclusion Criteria:

* Are cognitive or visual impairment.
* Received strong pain killer or sedative medication.
The Study of LTBP1 of Postmenopausal Women Osteoporosis Molecular Mechanism of Kidney Yang Deficiency Syndrome

Postmenopausal Osteoporosis is characterized by a decrease in bone mass as well as a deterioration of the bone architecture resulting in an increased risk of fracture,which is directly related to the lack of estrogen and also associated with a variety of genetic and acquired factors. Previous studies have found that POP molecular regulation mechanism of kidney Yang deficiency syndrome may be associated with LTBP1 gene expression.

This topic using RT-PCR and Western Blot detection POP of kidney Yang deficiency group and healthy group LTBP1 mRNA and proteion's expression level,validate LTBP1 relevance to POP the kidney Yang deficiency syndrome.To provide a scientific basis for clinical treatment.


Eligibility Criteria:
Inclusion Criteria:

* • The Participants who volunteer to be test subjects, and can accept experimental drugs, and promise to finish the course should sign the informed consent.

  * Female ages 45 to 75 had gone through natural menopause before two years
  * In accordance with the western medicine diagnostic criteria of osteoporosis and belong to kidney Yin deficiency syndrome differentiation of traditional Chinese medicine certificate;
  * In accordance with the western medicine diagnostic criteria;
  * In accordance with TCM diagnostic methods; .If any of the above answers are no, The subjects couldn't in the study

Exclusion Criteria:

* Do not accord with standard of the western medicine diagnosis and TCM diagnostic methods

  * Age: \<44 and \> 76 years old;
  * With hyperparathyroidism, osteomalacia, rheumatoid arthritis, multiple myeloma and other serious complications such as secondary osteoporosis; Late or deformity, disability, loss of labor;
  * With cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases;
  * Psychosis or alzheimer's patients;
  * Nearly three months, the use of hormone replacement therapy (HRT) and taking calcitonin, nearly six months has used double phosphonic acid salt for 15 days, etc.;
  * This medicine allergic constitution or composition of known to have allergies;
  * In a critical condition, It's difficult to make exact evaluators to efficacy and safety of the new drugs;
Study of the C5a/C5aR1 Axis in IgG4-associated Disease: a Potential Therapeutic Target

This is a monocentric, comparative, cross-sectional, case-control study seeking to identify abnormalities of the C5a-C5aR1 axis between a population of patients with active IgG4-associated disease (MAG4) and two control groups: healthy subjects without MAG4 and patients with MAG4 in remission.

IgG4-associated disease is a rare fibrosing and inflammatory disorder whose pathophysiology remains poorly understood. Activation of certain monocyte/macrophage populations (in particular M2-type macrophages) has been shown to be involved during the course of the disease. The mechanisms behind this monocyte/macrophage activation are not known. Expression of the C5aR receptor on the surface of these populations, and preliminary findings of elevated C5a in these patients, suggest a potential role for this C5a-C5aR axis. Demonstration of the involvement of this pathway would open a path to therapeutic perspetives (C5aR inhibitors) for these patients, who frequently suffer from cortico-dependence and relapses. The aim of this research is to use healthcare technologies to identify cellular and molecular therapeutic targets in the context of the IgG4-associated disease

Eligibility Criteria:
Inclusion Criteria for patients suffering from IG4-related disease and patients in remission :

* age \> 18
* diagnosis of IgG4-associated disease according to ACR/EULAR 2019 classification criteria (4,5) with a score ≥20.
* disease activity score (IgG4-RD Responder Index) ≥2 in at least one affected organ

Exclusion Criteria for patients suffering from IG4-related disease and patients in remission :

* presence of a differential diagnosis ("IgG4-RD mimicker") or exclusion criterion according to ACR/EULAR 2019 classification criteria (4,5).
* systemic corticosteroid treatment ≥5 mg/day ongoing or \< 1 month ; Study C5-MAG4_RCAPHM21_0433 Protocol Version 1.1 of 16/01/2024 Page 15 of 41
* immunosuppressive therapy ongoing or \< 3 months ;
* current biotherapy treatment or \< 6 months;
* absence of signed informed consent;
* absence of affiliation to a Social Security scheme.
* patient participating in an ongoing therapeutic trial ;
* any condition which, in the opinion of the investigator, could influence the results of the study.

Inclusion criteria for healthy volunteers :

- age \> 18

Exclusion criteria for healthy volunteers :

* infectious episode (temperature \>38°C, flu-like signs) in the 30 days prior to inclusion;
* known inflammatory (including IG4-related disease) or autoimmune pathology;
* treatment with corticosteroids in progress or taken in the month prior to sampling, or immunosuppressants in progress or taken in the 3 months prior to sampling, or biotherapy in the 6 months prior to sampling;
* absence of signed informed consent;
* absence of affiliation to a Social Security scheme;
* persons taking part in an ongoing therapeutic trial;
* any condition which, in the opinion of the investigator, could influence the results of the study.
Wound Catheter Vs LA Bolus in Renal Transplant: RCT

Pain control is an important part of patients' care after a kidney transplant. Currently patients receive a one off injection of Local Anaesthetic (LA) in the wound at the end of the operation followed by Intravenous morphine through a Patient Controlled Analgesia System (PCAS), a button pressed to provide a calculated dose with lock out times for safety.

Through this study the aim to test the efficiency of Continuous Local Anaesthetic Infiltration via Wound Catheter (LAWC) which is a method to deliver Local Anaesthetic over a longer period of time after the operation. LAWC are currently in use in a variety of surgical specialities including Liver surgery. Patients participating in this study will be allocated randomly to one of 2 groups; one will receive LA at the end of the operation as per current practice and one will receive LAWC. It then compare outcomes such as the the dose of morphine required in the PCAS, quality of pain control and improvement in recovery.


Eligibility Criteria:
Inclusion Criteria:

* Primary kidney transplantation
* Single kidney transplantation
* Signed informed Consent

Exclusion Criteria:

* Midline laparotomy
* Dual kidney transplantation
* Kidney re-transplantation
* Multi-organ transplantation
* Patients on Long term opiates
* Patients with psychiatric illness
Esmolol or Nitroglycerin Infusion for Blood Pressure Control Prior to Cardiopulmonary Bypass (CPB) in Cardiac Surgery

This is an investigator initiated, sponsored, open label, prospective randomized controlled trial to be performed in adult patients undergoing scheduled cardiac surgery. Patients will be randomized to esmolol infusion or nitroglycerin infusion for control of hypertension that occurs during cardiac surgery from induction of anesthesia to initiation of cardiopulmonary bypass (CPB).


Eligibility Criteria:
Inclusion Criteria:

* adult patients scheduled for cardiac surgery at LLUMC University Hospital will be eligible for participation in this study.

Exclusion Criteria:

1. severe LV (left ventricle)dysfunction (EF \< 35%).
2. emergency procedures.
3. procedures with combined carotid artery surgery.
4. patients at high risk for stroke.
5. hemodynamically significant dysrhythmias.
6. pre-existing atrial fibrillation or high degree AV (atrioventricular block).
7. pacemaker dependency.
8. known sensitivity to beta blockers.
9. patient refusal.
Transmission of Covid-19 During Clubbing Events in Closed Places

The ITOC study is a cluster randomised, controlled, multicentre trial in Paris region, France. The intervention is an 8-hour indoor clubbing event with no mask wearing, no social distancing, at maximum room capacity. 1,200 healthy volunteers aged 18-49 years and fully vaccinated will be included. Participants are recruited by group of up to 10, to be randomized 2:1 to experimental group (800 volunteers in a venue ) or control group (400 volunteers asked to stay at home). All participants will provide a salivary sample the day of experiment and seven days later. Participants will also answer surveys on the social and psychological impact of lockdown and indoor club closing, attitude towards vaccination, behaviour at risk of COVID-19 transmission during the day of the event (for both groups) as well as follow-up surveys on symptoms that participant may experience. Virological analyses include polymerase chain reaction (PCR) of salivary samples and air of the venue, investigating SARS-CoV-2 PCR.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 49 years old
* Vaccination completed
* People who declared to have no risk factor to severe form for Covid-19 disease
* People who declared not to live in the same place as someone with these risk factors
* People residing in Ile-de-France area
* People affiliated with the the French social security citizen scheme

Exclusion criteria:

* Presence of symptoms of COVID in the 2 weeks before the event
* Pregnant woman or woman who declares not having an effective contraception method
* Self identification of medical conditions or comorbidities identified as a proven risk of severe COVID infection
* People living with a person with these risk factors
* Confirmed diagnosis of SARS-CoV-2 within two weeks before the event
* Participants under tutorship or curatorship;
* Underage participants;
* Participants unable to give free and informed consent;
* Participants not affiliated to the French social security citizen scheme: obligation to join a social security scheme or be a beneficiary thereof.
* Participants under legal protection
Oligomeric Alpha-synuclein in Multiple System Atrophy

The main objectives are to determine on one hand whether oligomeric alpha-synuclein levels are increased in MSA patients compared to controls and on other hand whether there is a good agreement between cerebrospinal fluid (CSF) and plasma levels.

Multiple system atrophy (MSA) is a rare neurodegenerative disorder which is characterized by a variable combination of parkinsonism, cerebellar dysfunction, autonomic failure, and additional signs.

No effective treatment is available. Together with PD and Lewy body dementia, MSA belongs to a group of neurodegenerative disorders, the alpha-synucleinopathies, which are characterized by the abnormal accumulation of alpha-synuclein.

The development of biological markers for the diagnosis and prognosis in MSA remains an unmet need. Such biological markers are crucial for future disease-modification and neuroprotection trials. Alpha-synuclein has a high potential for biomarker development since it constitutes the pathological hallmark feature in MSA.

The oligomeric alpha-synuclein seems to be particularly involved in abnormal protein aggregation in alpha-synucleinopathies.

The study will compare alpha-synuclein levels in CSF and plasma between patients suffering from AMS and controls who are patients requiring spinal tap without being affected by a neurodegenerative disorder. The MSA patients and controls will receive CSF and blood sampling at one study visit.

Eligibility Criteria:
* MSA patients

  o Inclusion criteria: Patients suffering from "probable" MSA according to clinical consensus criteria (Gilman et al, 2008), Age \>30 Written informed consent Patient covered by the national health system

  o exclusion criteria: UMSARS IV score \> 4 points Patient under tutelage Patient unable to give consent Patients receiving anticoagulants, showing abnormal coagulation on blood testing or thrombocytopenia are excluded from this study
* Controls (patients requiring spinal tap without suffering from a neurodegenerative disorder) o Inclusion criteria: Patients not suffering from a neurodegenerative disorder and requiring a spinal tap Age \>30 Written informed consent Patient covered by the national health system o exclusion criteria: Similar to MSA patients
Evaluation of Pathogenesis and Diagnosis of Mycoplasma Pneumoniae Community-acquired Pneumonia (CAP)

To investigate the Mycoplasma pneumoniae-specific circulating antibody-secreting cell (ASC) response and Mycoplasma pneumoniae-specific interferon (INF)-γ-secreting T cell response, along with polymerase chain reaction (PCR) and serology, in a cohort of children with community-acquired pneumonia (CAP) and controls.


Eligibility Criteria:
Inclusion Criteria:

CAP cohort:

* Children of age 3 to 18 years;
* In- and outpatients;
* Clinically diagnosed community-acquired pneumonia (CAP);

Healthy control cohort:

- Healthy asymptomatic children of age 3 to 18 years undergoing an elective surgical procedure;

Family control cohort:

- Family members of index CAP patients.

Exclusion Criteria:

* Hospital-acquired pneumonia;
* Immunodeficiencies;
* Chronic lung disorders.
ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)

This study is being carried out to see if ZD4054 (Zibotentan) is effective in treating prostate cancer and spread of cancer to the bone, and if so, how it compares with placebo (sugar pill). The study will also provide further information on the safety of ZD4054 (Zibotentan).


Eligibility Criteria:
Inclusion Criteria:

* Surgically or medically castrated
* Bone metastasis
* Rising PSA

Exclusion Criteria:

* Opiate use
* Prior chemotherapy
Genetic and Nutritional Causes of Heart Birth Defects

Each year in the United States, thousands of babies are born with heart defects. Women who take folic acid during pregnancy have a lower risk of giving birth to infants with heart defects, but the reason for this remains unknown. This study will examine the relationship between genes, nutrition, and the occurrence of heart defects in infants.

Congenital heart defects are the most common type of birth defect; each year, more than 30,000 babies in the United States are born with this kind of abnormality. Conotruncal heart defects, considered to be a very serious type of defect, involve a structural abnormality in the chambers of the heart or blood vessels that lead to and from the heart. Infants born with conotruncal defects must undergo complex open heart surgery, and there is a high fatality rate. Folic acid supplementation during pregnancy has been shown to reduce the risk of conotruncal defects. However, some women who take folic acid during pregnancy still give birth to infants with conotruncal defects. Specific genes may influence the way individuals metabolize folic acid, and variations in these genes may make some infants more prone to developing heart defects. This study will examine the relationship between genes, maternal nutritional intake, and conotruncal heart defects. The results from this study may help to determine genetic and nutritional causes of congenital heart defects.

This study will use previously collected data on 550 infants born with conotruncal defects and 1060 infants born without heart defects. There will be no study visits specifically for this study. Infant DNA will be analyzed for genes that may play a role in folate metabolic pathways. Blood previously collected from the mothers during pregnancy will be analyzed for differences in nutrient intake. Specifically, levels of folic acid, choline, vitamin B12, and methionine will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Conotruncal heart defect

Exclusion Criteria:

* If part of control group, must not have heart defect
SARS-CoV-2 Antibody Response in Children Aged 5-11 Years Following Vaccination Against COVID-19

There are few data on the immunogenicity of the Pfizer-Biontec BNT162b2 vaccine for the prevention of COVID-19 disease and of side effects in children aged 5-11 years. Therefore, our aim is to determine the immunogenicity and to describe the local or systemic reactogenicity events after vaccination with the BNT162b2 COVID-19 vaccine in children aged 5-11 years for a period of six and half months following the first dose of the vaccine.

The Pfizer-Biontec BNT162b2 vaccine has proven efficacy and safety for the prevention of COVID-19 disease in adults and adolescents aged 12 years and older. Efficacy and safety were recently shown also for children aged 5-11 years. Side-effects are common, including some rare but important side-effects such as myocarditis. Myocarditis post Pfizer-Biontec BNT162b2 vaccination was described mostly among male adolescents and young adults. There are few data on the immunogenicity of the vaccine and of side effects in children aged 5-11 years. Therefore, our aim is to determine the immunogenicity and to describe the local or systemic reactogenicity events after vaccination with the BNT162b2 COVID-19 vaccine in children aged 5-11 years.

This is a prospective cohort study assessing the immunogenicity of the BNT162b2 COVID-19 vaccine in children. The study population will be composed of children aged 5-11 years at the Schneider Children's Medical Center, with no contraindication for COVID-19 vaccination. Upon enrollment in the study, participates will be requested to complete an enrollment questionnaire and a blood sample for baseline serological evaluation will be obtained.

The study follow-up period will be 6 and a half months from receipt of the first dose of the vaccine. The study will last 6 months from the date of the approval of the study protocol.

Blood samples for immune response evaluation will be taken at intervals of 28 days (+/- 14) until 6 and a half months from receipt of the first dose of the vaccine. Samples will be tested for antibodies to SARS-CoV-2 at the Microbiology Laboratory at the Rabin Medical Center. Symptomatic participants with any respiratory symptoms or other symptoms suggestive of COVID-19 disease will be tested for SARS-CoV-2 by RT-PCR, at laboratories certified by the Ministry of Health.

Eligibility Criteria:
Inclusion Criteria:

Age 5-11 years

Exclusion Criteria:

Administration of COVID-19 vaccine\>21 days prior to enrollment, Contraindication for COVID-19 vaccine such as, known hypersensitivity to a component of the vaccine or its excipients Congenital or acquired immunodeficiency (including recipient of systemic steroids ≥2 mg/kg or ≥20mg/day, within two weeks prior to enrollment)
Placebo and Active Controlled Study of Rivoglitazone in Type 2 Diabetes

This is a 6-month study to evaluate the effects of monotherapy with rivoglitazone, an insulin sensitizer, on glycemic control in newly identified type 2 diabetics or diabetics not adequately treated with other antidiabetic agents. The study tests rivoglitazone and uses a placebo and active treatment group for comparison.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes in male or female patients
* Between 18 and 75 years of age
* With a HbA1c greater than or equal to 7.5% and less than 10.5% at randomization

Exclusion Criteria:

* Type 1 diabetics or type 2 diabetics currently on insulin therapy
* Patients unwilling or unable to discontinue their anti-diabetic medication(s)
* History of ketoacidosis
* History of therapy with rosiglitazone, troglitazone, pioglitazone