cyrilzakka/clinical-trials huggingface dataset:
Interest of Using Deep Learning Algorithm for Otosclerosis Detection on Temporal Bone High Resolution CT

Otosclerosis is a relatively frequent pathology, of multifactorial origin with genetic and hormonal part, predominantly in women. This disease causes a disorder of the bone metabolism of the middle and inner ear, responsible for a progressive deafness, which can become severe.

Several elements are necessary to make the diagnosis of otosclerosis: the clinical examination and questioning, the audiometric assessment, and finally the temporal bone CT.

The CT scan allows to detect foci of otosclerosis within the bone of the middle or inner ear. This diagnosis is sometimes difficult and requires interpretation by a trained radiologist.

The investigators would like to evaluate the ability of a deep learning algorithm to detect these foci of otosclerosis, and to compare its diagnostic performance with a trained radiologist.

Otosclerosis is a relatively frequent pathology, of multifactorial origin with genetic and hormonal part, predominantly in women. This disease causes a disorder of the bone metabolism of the middle and inner ear, responsible for a progressive deafness, which can become severe.

Several elements are necessary to make the diagnosis of otosclerosis: the clinical examination and questioning, the audiometric assessment, and finally the temporal bone CT.

The CT scan allows to detect foci of otosclerosis within the bone of the middle or inner ear. This diagnosis is sometimes difficult and requires interpretation by a trained radiologist.

The investigators would like to evaluate the ability of a deep learning algorithm to detect these foci of otosclerosis, and to compare its diagnostic performance with a trained radiologist.

Eligibility Criteria:
* Inclusion Criteria \* :

  * age over 18
  * high resolution temporal bone CT scan available for analysis
  * for the "case" group : surgical confirmation of positive diagnosis for otosclerosis
  * for the "control" group : a first radiological analysis in favor of a normal temporal bone CT scanner and an initial radiologic report considered normal as well
* Exclusion Criteria \* :

  * age under 18
  * no high resolution temporal bone CT scan available for analysis
  * unwillingness to participate in the study
Study to Assess the Efficacy and Safety of Orismilast in Atopic Dermatitis (ADESOS)

This study investigates 3 different doses of orismilast modified release compared to placebo in adult patients with moderate-to-severe atopic dermatitis. The purpose of the study is to assess the effect of orismilast modified release in moderate-to-severe atopic dermatitis and assess the safety aspects of these 3 different doses. The patients will receive an oral treatment of either orismilast modified release tablets or placebo tablets 2 times a day for 16 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Capable of giving signed informed consent.
2. Male and female patients ≥18 years of age
3. Body weight of \>40 kg
4. Diagnosis of AD for a minimum of 1 year (before the Screening visit) using the Hanifin and Rajka criteria
5. Moderate to severe AD (affected BSA at least 10%, IGA-AD grade of at least 3, and EASI score of at least 16) at the screening and baseline visits
6. Candidate for systemic treatment or phototherapy for AD

Exclusion Criteria:

1. Therapy-resistant atopic dermatitis
2. Unstable AD with acute deterioration, requiring rescue therapy for AD within 4 weeks of the Screening visit or expected to require rescue therapy within 2 weeks after randomization
3. History of allergy or hypersensitivity to any component of the study treatment
4. Active infection (eg, bacterial, viral, fungal) requiring treatment with systemic antibiotics within 4 weeks of the Screening visit
5. Malignancy or history of malignancy except for treated (ie, cured) basal cell skin carcinoma
Inhaled Corticosteroid Withdrawal in Chronic Obstructive Pulmonary Disease (COPD)

According to the WISDOM study, withdraw of inhaled steroids has no effect on the acute exacerbation of chronic obstructive pulmonary disease (COPD), but the lung function of patients with COPD is significantly reclined. In the subgroup analysis of this study, patients with COPD were found to have continued to use inhaled steroids in patients with eosinophilic leukocytes greater than 400 cells/ul or whom has more than two episodes of exacerbation per year. However, in SUNSET study, it was pointed out that withdraw of inhaled steroids had no effect on lung function in patients with COPD, but it was also found that in patients with COPD, eosinophilic leukocytes in the blood were greater than 300 cells/ul, have a better therapeutic response in steroid inhalation. In addition, some studies have shown that in patients with COPD, a decline in lung function after discontinuation of inhaled steroids can make the patient's clinical symptoms worse and increase the risk of acute exacerbations. However, in other comprehensive analytical studies, there are different outcomes. There is no statistically significant difference in the risk of acute exacerbation in patients with COPD after discontinuation of inhaled steroids.

In past studies, it was noted that inhaled steroids cause an increased risk of pneumonia in patients with COPD. However, in these studies, the diagnosis of pneumonia was only from the clinician's suspicion without clear symptom assessment, laboratory examination, microbiological evidence or imaging assessment. Therefore, further research is needed to assess whether patients are suitable for the reduction of inhaled steroids and the impact of COPD in clinical treatment.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed patients with COPD (at least one lung function test post bronchodilator FEV1/FVC \<70% before the start of the study)
* Age ≥ 40 years old
* No acute attack record within half a year
* Triple therapy (dual long-acting inhaled bronchodilator and inhaled steroid) is stable for more than six months.
* Eosinophil count in blood \<300 cells/ul
* Clinical symptom assessment CAT score \<20

Exclusion Criteria:

* Suspected or diagnosed with asthma
* Age \<40 years
* Within half a year, there is a record of moderate to severe acute attacks
* Eosinophil count in blood ≥300 cells/ul
* Clinical symptom assessment CAT score ≥20
REVEAL for Respiration Detection

This study will evaluate the correlation between the respiratory rate derived from the Reveal Insertable Cardiac Monitor (ICM) electrocardiogram (ECG) with the respiratory rate obtained from an external respiratory band in patients previously implanted with a Reveal for unexplained syncope or suspected arrhythmia.


Eligibility Criteria:
Inclusion Criteria:

* Subject is implanted with a Reveal ICM or Reveal XT ICM for unexplained syncope or suspected arrhythmia
* Subject (or the legal representative) is willing to sign informed consent form
* Subject is 18 years or older or as specified minimal age per local law/regulation

Exclusion Criteria:

* Significant respiratory diseases such as COPD or pulmonary hypertension.
* Patients with frequent arrhythmias, including PVC's.
* Patients with known heart failure.
* Body conditions that would complicate accurate measurement of respiratory rate with the respiration device.
* Patients which are not able to take the postures as necessary for the study protocol and which cannot walk continuously for a period of 6 minutes.
* Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control.
* Subject is enrolled in one or more concurrent studies that would confound the results of this study
Buccal Versus Intranasal Route of Administration of Midazolam Spray in Behavior Management of Pre-School Patients

Purpose of this study was to assess the efficacy of aerosolized midazolam, introduced through buccal versus intranasal mucosa in managing uncooperative children undergoing dental treatment.

Thirty six children fulfilling the requirements of having a dental condition that needed treatment in two dental settings, not exceeding thirty minutes each. They were randomly assigned to one of two groups, according to the treatment offered at the first visit. At the first visit, either buccal or intranasal aerosolized midazolam was administered. At the second visit the alternate route was implemented in a cross-over design with a one week washout period. Vital signs were recorded at baseline and at 5 minutes interval throughout the treatment session.

Eligibility Criteria:
Inclusion Criteria:

* Negative and definitely negative behavior according Frankl's scale.
* ASA Group I (normal healthy patient without systemic disease) and II (patient with mild systemic disease) with no medical contraindication which rules out the use of midazolam.
* Children with at least two carious lesions requiring dental intervention in two settings of not more than 30 minute each.

Exclusion Criteria:

* Children with multiple carious lesions who require treatment under general anesthesia.
TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention

The aim of the project is to evaluate the risk-reducing salpingectomy with delayed oophorectomy as an alternative for risk-reducing salpingo-oophorectomy in high risk women with respect to ovarian cancer incidence.

In BRCA1/2 gene mutation carriers, a risk-reducing salpingo-oophorectomy (RRSO) is recommended around the age of 40. This recommendation is based on a 10-40% life-time risk of ovarian cancer in this population and disappointing results of ovarian cancer surveillance for early detection. Moreover, the mortality rate of ovarian cancer is high. Effects of RRSO are a decrease in ovarian cancer risk (80-96%) on one hand and immediate onset of menopause and non-cancer related morbidity on the other hand. The fifty percent breast cancer risk reduction after RRSO has become disputable in the last years. Based on multiple studies showing that most high-grade serous ovarian cancers develop at the distal end of the Fallopian tube, an innovative strategy for RRSO has been developed for this study proposal: risk-reducing salpingectomy (RRS) with delayed risk-reducing oophorectomy (RRO). However, the safety of this strategy has not been proven yet. Before implementing this innovative strategy as standard care we need to investigate the long term effects on ovarian cancer incidence.

Eligibility Criteria:
Inclusion Criteria:

* Women with a class 5 (definitely pathogenic) BRCA1, BRCA2, RAD51C, RAD51D or BRIP1 germline mutation in one of the participating centers.
* Age at inclusion;

  * BRCA1: 25-40 years
  * BRCA2: 25-45 years
  * RAD51C, RAD51D, BRIP1: 25-50 years
* Childbearing completed
* Presence of at least one fallopian tube
* Participants may have a personal history of non-ovarian malignancy
* Informed consent must be obtained and documented according to national and local regulatory requirements and the local rules followed in the institution.

Exclusion Criteria:

* Postmenopausal status (natural menopause or due to treatment)
* Wish for second stage RRO within two years after RRS
* Legally incapable
* Prior bilateral salpingectomy
* A personal history of ovarian, fallopian tube or peritoneal cancer
* Current diagnosis or treatment for malignant disease
Physiotulle vs Urgotul in the Treatment of Leg Ulcer

The aim of this study is to assess the pain at removal of Physiotulle dressing in comparison with that of Urgotul dressing in patients presenting a venous (or predominantly) venous leg ulcer.


Eligibility Criteria:
Inclusion Criteria:

* Patient of either sex over 18 who have not been declared legally incompetent and who having given his written informed consent
* Patient with venous or predominantly venous leg ulcer (ankle-brachial index \> 0.8)
* Patient with venous or predominantly venous leg ulcer in granulation phase (granulation tissue \> 70 %)
* Patient with venous or predominantly venous leg ulcer with low exsudate
* Patient with venous or predominantly venous leg ulcer with a wound surface between 4 cm² and 170 cm²
* Patient with venous or predominantly venous leg ulcer that has been treated with an appropriate compression in the two weeks prior to inclusion
* Patient available to be monitored for at least 4 weeks
* Patient able to answer questionnaires and particularly to evaluate his pain

Exclusion Criteria:

* Patient whose leg ulcer is locally infected (At least 3 of 5 clinical signs suggestive of infection \*)\* 5 signs suggestive of infection: pain, exsudate, smell, oedema, erythema
* Patient requiring an analgesic treatment for the care (before dressing removal)
* Patient whose ulcer belongs to angiodermatitis type or demonstrates a vasculitis
* Patient with arterial ulcer
* Patient with purely traumatic, infectious or neoplastic origin ulcer
* Patient with a diabetic neuropathy of lower limbs
* Patient with a known allergy to one of Physiotulle or Urgotul components
* Patient already participating in another clinical study
* Pregnant or breastfeeding patient

Patient who have been taking corticoids \> 10mg / day or cytostatics by systematic way for the three months prior to inclusion

Patient who have undergone surgery of saphenous trunk in the two months prior to inclusion
Intraoperative Radiotherapy for Early Stage Breast Cancer

Up to 200 patients with biopsy proven early stage breast cancer selecting Wide Local Excision (WLE) will undergo mammography, ultrasound (of affected breast and ipsilateral axilla) and contrast enhanced-magnetic resonance imaging (CE-MRI) of the affected breast to evaluate the extent of disease.

Patients will be deemed eligible for immediate IORT if the invasive cancer lesion is estimated to measure ≤ 3.0 centimeters maximum dimension by mammogram, ultrasound, and CE-MRI and is thought to be resectable with WLE and clear surgical margins, with clinically staged N0M0 disease, minimum age of 48, and histology of invasive ductal or lobular carcinoma of the breast. The lesion size determined by imaging will be compared with lesion size and surgical margin status obtained from the surgical pathology specimen to evaluate the ability of mammography combined with ultrasound and CE-MRI to identify suitable candidates for immediate IORT.

Eligibility Criteria:
Inclusion Criteria:

1. Informed Consent. Each eligible patient must willingly give written consent after being informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts.
2. Histology. Patients must have biopsy-proven invasive ductal or lobular carcinoma of the breast.
3. Female, age ≥ 48 years.
4. Clinically and/or histologically negative axillary lymph nodes.
5. No imaging or clinical findings that indicate metastatic disease.
6. Procedure deemed appropriate based upon factors such as breast size by the treating surgeon and radiation oncologist.

Exclusion Criteria:

1. Male sex
2. Age \< 48
3. Non-epithelial breast malignancies such as sarcoma, lymphoma, or metastatic breast cancer
4. Pregnancy or lactation
5. Serious psychiatric or addictive disorders
6. More than one obvious cancer in the same breast as diagnosed by clinical examination, mammography, ultrasonography, and/or CE-MRI.
7. Bilateral breast cancer at the time of diagnosis, unless agreed upon by the surgeon and radiation oncologist.
8. Ipsilateral breast with a previous cancer and/or irradiation.
9. Extensive Intraductal Component (DCIS ≥ 25% of the tumor).
10. Patients presenting with gross nodal disease considered to be clinically malignant by scanning or proven cytologically or by sentinel node biopsy will be cancelled.
11. Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years is 90% or greater.
12. Lymphovascular invasion on needle biopsy.
13. Patients undergoing primary medical treatment (hormones or chemotherapy) as initial treatment with intent to reduce tumor size.
Managing Sleep-wake Disruption Due to Hospitalisation: the Circadian Care Project

Sleep is regulated by the interaction of homeostatic and circadian processes. The homeostatic process determines sleep propensity in relation to sleep-wake history, the circadian one is responsible for the alternation of high/low sleep propensity in relation to dark/light cues, and is substantially independent of preceding sleep-wake behaviour. The circadian timing system encompasses a master clock in the brain and peripheral, ancillary time-keepers in virtually every organ of the body.

In recent years, evidence has emerged that circadian disruption has serious medical consequences, including sleep loss, increased cardiovascular morbidity and increased risk of certain types of cancer. Evidence is also emerging that hospitalization per se weakens circadian rhythmicity, due to disease itself and to modified light, food and activity cues.

The aim of our project is to test an inpatient management system (CircadianCare) that limits the circadian impact of hospitalisation by enhancing circadian rhythmicity through an assessment of the patient's specific circadian features/needs and an ad hoc, personalized light-dark, meal and activity schedule to cover the whole of the inpatient stay. This will be compared to standard inpatient management in terms of patients' perception, sleep-wake quality and timing during hospitalisation, inpatient utilization of sleep-inducing medication, length of hospitalisation, and prognosis (i.e. outcome of hospitalisation, subsequent hospitalisations and post-discharge sleep-wake disturbances).

The CircadianCare system is expected to benefit prognosis, decrease costs, and change the way hospitals are organized and designed in future, with potential direct relevance to the plans for the new University Hospital of Padova.


Eligibility Criteria:
Inclusion Criteria:

• Hospitalized patients

Exclusion Criteria:

• absence of compliance
Plasma and Platelet microRNAs in Clopidogrel Low Response Patients

Clopidogrel is an important anti-platelet agent.However, about 30% of the coronary artery disease patients presented clopidogrel low response (CLR).Previous studies showed that the cardiovascular event ratio of the CLR patients was 4.4 times of the normal responders.

It is known that the plasma and platelet miRNAs are determined by different disease status when platelets are released from the megakaryocyte, and the platelet miRNAs can adjust the expressions of the platelet's receptors and proteins.The purpose of this study is to find multiple platelet miRNAs involved in the development of CLR, and platelet miRNAs cause CLR through adjusting the expressions of the key receptors and proteins in the ADP activating pathway and consequently reducing their responses to clopidogrel.

The CLR will be detected by light transmission aggregometry (LTA) and vasodilator-stimulated phosphoprotein phosphorylation (VASP-P). Differential expressions of plasma and platelet miRNAs profile in CLR patients will be screened by deep sequencing and validated to investigate the association between plasma and platelet miRNAs profile and CLR as well as the patients' prognosis.The study results would serve as markers for individualized anti-platelet treatment, and supply new targets for the treatment of coronary artery disease.

A multiphase, case-control study was designed to identify plasma and platelet miRNAs as surrogate markers for CLR .

All patients take 300mg loading dose clopidogrel plus 100mg daily ASA and 75mg daily clopidogrel after admission. Patients are recruited after percutaneous coronary intervention (PCI). Light transmittancy aggregation (LTA) in response to 5μM ADP is to measured 5 days after taking the loading dose clopidogrel.Than CLR patients were selected.

In the initial biomarker-screening stage, plasma and platelet samples from 20 CLR patients and 20 controls underwent Solexa sequencing to identify miRNAs that showed significant differences between the CLR cases and matched controls.

Subsequently,we performed a biomarker confirmation analysis with a hydrolysis probe-based RT-qPCR assay to refine the number of plasma and platelet miRNAs in the CLR signature. This analysis was carried out in 2 phases: (a) the biomarker-selection phase, in which plasma and platelet samples from 20 CLR patients and 20 control individuals formed the training set, and (b) the biomarker-validation phase, in which plasma and platelet samples from an additional 80 CLR patients and 80 controls formed the validation set.

Eligibility Criteria:
Inclusion Criteria:

* Patients who receive stent implantation;
* Patients who take 100mg daily ASA and 75mg daily clopidogrel
* Patient age \>18 years and \<80 years old;
* Signed inform consent

Exclusion Criteria:

* Allergy or intolerance to ASA,clopidogrel;
* Patients who are planning to take warfarin or drugs that potentially could interfere with the anti-platelet effects of ASA,clopidogrel.
0.5% Bupivacaine Lower Cervical Intramuscular Injection vs IV Medications for Headache Treatment

Headache is a frequent chief complaint among patients presenting to the Emergency Department (ED), accounting for 2.1 million visits annually in the United States. Often, individuals resort to ED care only after over-the-counter or home remedies have failed, leading to the predominant use of intravenous (IV) medications in the ED, including NSAIDs, triptans, neuroleptics, antiepileptics, and dopaminergic antagonists. Unfortunately, these pharmacologic treatments frequently induce side effects such as cognitive impairment, extrapyramidal reactions, and the potential for medication dependency. In the ED, patients frequently require concurrent administration of multiple systemic medications to achieve satisfactory pain relief, thereby elevating the risk associated with medication use. Despite these medication regimens, a significant portion of patients continue to experience inadequate pain relief. Consequently, the search for an optimal headache therapy-characterized by rapid and effective pain relief, long lasting results, minimal side effects, and allows for rapid ED patient turnover-continues to be a popular area of research in emergency medicine. The investigators plan to evaluate the use of 0.5% bupivacaine cervical IM injection at the c6-7 location for the treatment of non traumatic headaches using a non-inferiority design, randomized, prospective, open-label, controlled trial comparing it to physicians choice of intravenous medications in treatment of headache in the Emergency Department at North Florida Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Patient has to be able to provide own consent
* English-speaking only
* Non traumatic headache with VAS pain score of 5 or above out of 10

Exclusion Criteria:

* traumatic headache
* Confused patients
* allergy to bupivacaine
* infection over injection site
* recent neck surgery
* hemodynamically unstable
* bleeding disorder
* anticoagulation use
* pregnant, lactating women
* prisoners
Bio-ADM as a Biomarker of Refilling in Chronic Hemodialysis Patient

Aim of this study is to evaluate in a population of chronic kidney disease patients on dialysis (Stage 5D) the predictive value of bio-adrenomedullin (bio-ADM) level on vascular refilling rate.


Eligibility Criteria:
Inclusion criteria:

* Chronic Kidney Disease patient on dialysis (stage 5D) for more than 1 month
* Anuric patient

Exclusion criteria:

* Patient protected by law
* Patient under guardianship ou curatorship
* Patient deprived of liberty