cyrilzakka/clinical-trials huggingface dataset:
Measuring the Quality of Surgical Care and Setting Benchmarks for Training Using Intuitive Data Recorder Technology

MASTERY is a multi-centre prospective cohort study involving patients undergoing robotic assisted surgery for prostate, colorectal, lung, gynaecological, hepatobiliary, and ear, nose \& throat tumours.

MASTERY will create a data collection platform to capture, annotate and analyse digital point of care data relating to surgeon's performance during live surgery. This is a multi-centre prospective cohort study involving patients undergoing robotic assisted surgery for prostate, colorectal, lung, gynaecological, hepatobiliary, and ear, nose \& throat tumours. In this study, automated digital point of care data relating to the surgeons' performance will be collected via the Intuitive Data Recorder (IDR) device (Intuitive Surgical Inc, USA). Data collection will also encompass surgeon characteristics, patient characteristics, 30-day clinical outcomes including surgical complications, reoperation, length of stay and hospital readmission. This will also include collection of baseline, 30- and 90-day patient reported outcomes data.

MASTERY is the first study of the RCS Robotics Working Group and aims to initially recruit 500 patients across 13 centres in United Kingdom from January 2021.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 16years
* Patients undergoing robotic assisted surgery for prostate, colorectal, lung, gynaecological, hepatobiliary, and ENT tumours
* Patients consenting to data collection who are scheduled to undergo robotic assisted surgery

Exclusion Criteria:

* Age \< 16years
* Patients undergoing robotic surgery for other indications not relevant to the study
* Patients not consenting to data capture
The Impact of Different Scanning Methods and Reconstruction Algorithms on CT Image Quality

Purpose: To evaluate the image quality of deep learning-based image reconstruction (DLIR) algorithm in unenhanced abdominal low-dose CT (LDCT).

Methods: CT images of a phantom were reconstructed with Hybrid iterative reconstruction and deep learning image reconstruction (DLIR). The noise power spectrum (NPS) and task transfer function (TTF) were measured. Two patient groups were included in this study: consecutive patients who underwent unenhanced abdominal standard-dose CT reconstructed with hybrid iterative reconstruction (SDCT group) and consecutive patients who underwent unenhanced abdominal LDCT reconstructed of HIR and DLIR (LDCT group). The CT values, standard deviation (SD), signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR) of the hepatic parenchyma and paraspinal muscle and abdominal subcutaneous fat were evaluated. Radiologists assessed the subjective image quality and lesion diagnostic confidence using a 5-point Likert scale. Quantitative and qualitative parameters were compared between SDCT and LDCT groups.


Eligibility Criteria:
Inclusion Criteria:

Abdominal CT examination

Exclusion Criteria:

pregnancy and lactation for women unstable breath holding
COVID-19 Thrombosis Prevention Trials: Post-hospital Thromboprophylaxis

A multicenter, adaptive, randomized platform trial evaluating the efficacy and safety of antithrombotic strategies in patients with COVID-19 following hospital discharge

This study is an adaptive, prospective, randomized platform trial designed to compare the effectiveness and safety of antithrombotic therapy with no antithrombotic therapy after hospitalization for 48 hours or longer for COVID-19. For Stage 1 of this study, participants will be randomized to either prophylactic anticoagulation or matching placebo for 30 days, and then followed for an additional 60 days after the completion of treatment (total duration of follow-up, 90 days).

The primary objective is to determine the most effective and safe antithrombotic strategy to prevent the composite outcome of symptomatic deep vein thrombosis, pulmonary embolism, other venous thromboembolism, ischemic stroke, myocardial infarction, other arterial thromboembolism, and all-cause mortality by 30 days following discharge from the hospital.

Biobanking of samples for future biomarker and mechanistic studies will be available for centers able to participate and collect samples from eligible participants. Samples will be collected at the time of enrollment and after the completion of 30 days of therapy

Eligibility Criteria:
Inclusion Criteria:

* • Age ≥ 18 years

  * PCR-positive COVID-19 infection
  * Hospitalized for two or more days

Exclusion Criteria:

* Pre-existing indication for anticoagulation (e.g., pulmonary embolism or deep vein thrombosis; atrial fibrillation; mechanical cardiac valve)
* Contraindication to antithrombotic therapy (e.g., known bleeding within the last 30 days requiring emergency room presentation or hospitalization; major surgery within 14 days; ischemic stroke, intracranial bleed or neurosurgery within 3 months.
* Platelet count \< 50,000/mcL
* Hemoglobin \<8 gm/dL
* Renal insufficiency (eGFR \< 30 mL/min/1.73 m2)
* Pregnancy
* Prison inmate
* Life expectancy less than 90 days
* Unwilling or unable to provide informed consent/unwilling or unable to complete the study protocol
* Dual antiplatelet therapy that cannot be discontinued
* Concomitant need for strong inducers/inhibitors of p-gp or CYP3A4
Study of Methyl Aminolaevulinate Photodynamic Therapy With and Without Er:YAG Laser in Actinic Cheilitis

Methyl aminolaevulinate photodynamic therapy (MAL-PDT) is advantageous in that it has few cosmetic side effects and minimises patient discomfort. However, its relatively low efficacy prevents its application to the treatment of actinic cheilitis(AC). Er:YAG ablative fractional laser (AFL) treatment removes the stratum corneum to increase MAL uptake and may improve efficacy. However, no studies have directly compared the efficacy of MAL-PDT with and without Er:YAG AFL in treating AC

Actinic cheilitis (AC) is a keratinocytic neoplasm of the lip, especially the lower lip, is confined to the epidermis, and results from chronic or excessive ultraviolet exposure. AC is an early manifestation of lip squamous cell carcinoma (SCC), and SCC of the lip is usually associated with an identifiable pre-existent AC. Furthermore, the likelihood that AC will progress to SCC is higher than actinic keratosis (AK). Consequently, early identification and treatment of AC is recommended. PDT involves the activation of a photosensitizer by irradiation with 400- to 700-nm light to create cytotoxic oxygen and free radicals that kill dysplastic cells.

Methyl aminolaevulinate photodynamic therapy (MAL-PDT) is advantageous in that it has few cosmetic side effects and minimises patient discomfort. However, its relatively low efficacy prevents its application to the treatment of actinic cheilitis(AC).

Erbium:yttrium-aluminium-garnet (Er:YAG) ablative fractional laser (AFL) therapy has been used frequently to improve treatment efficacy of PDT. Er:YAG AFL can ablate stratum corneum with minimal penetration depth and producing minimal thermal injury. This approach creates microscopic vertical holes in the ablated tissue, surrounded by thin layers of coagulated tissue. Er:YAG AFL does not injure the entire thickness of the epidermis; therefore, healing times are minimised. Erbium:yttrium-aluminium-garnet (Er:YAG) ablative fractional laser (AFL) has been proven in recent studies to facilitate the delivery and uptake of topical MAL deep into the skin, enhancing porphyrin synthesis and photodynamic activation.

The aim of our study was to compare efficacy, recurrence rate, cosmetic outcome, and safety between Er:YAG AFL-assisted MAL-PDT (Er:YAG AFL MAL-PDT) and standard MAL-PDT in patients with AC.

Eligibility Criteria:
Inclusion Criteria:

* Korean patients ≥ 18 years of age who had biopsy-confirmed AC lesions

Exclusion Criteria:

* porphyria
* known allergies to the MAL cream or lidocaine
* pregnancy
* lactation
* any active systemic infectious disease
* immunosuppressive treatment
* personal history of malignant melanoma
* tendency towards melasma or keloid formation
* prior treatment of the lesions within 4 weeks
* any indication of poor compliance
Analysis of the Impact of Patent Ductus Arteriosus on Brain Function in Preterm Neonates: Multimodal Approach Integrating EEG-NIRS, Ultrasound and Clinical Data

This project corresponds to the main field of research of the investigators's laboratory concerning analysis of cerebral electrometabolic and haemodynamic activity in neonates. In this context, the investigators have developed know-how and specific acquisition and analysis tools (2 patents and several publications), allowing them to apply this know-how in children with patent ductus arteriosus.

Patent ductus arteriosus after birth is characterized by shunting of a variable proportion of cardiac output towards the pulmonary circulation. The direct consequences of this shunting are: (i) overload of the pulmonary vasculature and left heart chambers, increasing the risk of left heart failure, haemorrhagic pulmonary oedema and late respiratory complications such as bronchopulmonary dysplasia; (ii) in contrast with the pulmonary circulation, other systemic organs are deprived of part of their normal perfusion and are subject to ischaemic hypoxia; the resulting neuronal hypoxia rapidly leads to metabolic and electrical dysfunction, the analysis of which constitutes one of the objectives of this project.


Eligibility Criteria:
Inclusion Criteria:

1. Group of children :

   * meeting the age criteria
   * having a ductus arteriosus persistence.
2. Group of children :

   * meeting the age criteria
   * with persistent ductus arteriosus in the ultrasound examination
   * for which a cardiac or respiratory treatment has already been put in place.
3. normal group of children :

   * meeting the age criteria
   * without ductus arteriosus persistence ultrasound or detectable neurological disorders after clinical, neurophysiological and radiological (ETF , Scanner, MRI).

Exclusion Criteria:

-
Development and Validation of a Fast, Semi-Automated Hybrid Imaging Platform to Assess Coronary Atherosclerotic Plaque Morphology, Endothelial Shear Stress and Arterial Inflammation: A Proof of Principle Study (VALID-PET-CT)

Imaging the inside of coronary arteries (intravascular imaging) offers great insight into the assessment and treatment of coronary artery disease. Over time, substances such as fat, cholesterol and calcium can build up into 'plaques' in the arteries, causing narrowings or even blockages. These plaques can also rupture, causing cardiovascular events such as heart attacks or strokes. By using ultrasound and infrared technology, intravascular imaging can help assess these plaques, however this is an invasive technique involving angiography. Plaque composition, structure and stability can be affected by inflammation and the stress that the arteries are under. The investigators have pioneered novel minimally-invasive methods for modelling arterial stress using computed tomography coronary angiography (CTCA), as well as imaging coronary arterial inflammation using a positron emission tomography (PET) scan. Before embarking upon a large-scale clinical outcome study to determine whether these novel methods can improve risk prediction, the aim is to perform a proof-of-principle study to further develop our methodology for hybrid image analysis, and to validate this technique against high-resolution intravascular imaging as a surrogate marker of histology.


Eligibility Criteria:
Inclusion Criteria

1. Age ≥40
2. Stable angina, defined as typical symptoms with evidence of reversible ischemia in non-invasive test and/or documented obstructive coronary artery disease on coronary angiography
3. Patient that is willing and can provide written informed consent.

Exclusion Criteria

1. Acute coronary syndrome within \<3 months
2. Pregnancy
3. Estimated glomerular filtration rate (eGFR) \<60ml/min/1.73m²
4. Previous bypass surgery
5. Decompensated heart failure, or left ventricular ejection fraction less than 30%
6. Patient allergic to contrast or cannot receive treatment with aspirin, heparin, or thienopyridines
7. Anticipated life expectancy \<2 years
8. Flow limiting coronary artery disease in the proximal segments of all the 3 epicardial coronaries
9. History of heart transplantation
10. Patient that requires surgical revascularization
11. Extensive coronary artery disease (i.e., multiple chronic total occlusions) or tortuous coronary anatomy that does not allow assessment of the
Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1 and 1.5% in 48 Healthy Volunteers

To compare the ocular tolerance, safety and ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225.

The present phase I clinical trial was performed in order to investigate the ocular tolerance, safety and the ocular pharmacokinetics of a single administration of T1225 eye drops (0.5%, 1.0%, or 1.5%) in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged from 18 to 45 years old;
* Written informed consent;
* Healthy volunteers (without any ocular symptom);
* Normal ocular examination in both eyes (corrected visual acuity (VA) \>= 6/10 - slit lamp examination without clinical relevant abnormalities - tear break-up time (BUT) \>= 10 seconds - lachrymal secretion in the Schirmer test \>= 10 mm in 5 minutes - lissamine green test total score \< 4).

Exclusion Criteria:

* Ocular trauma, infection or inflammation within the last 3 months;
* Conjunctival hyperaemia score \>= 2, watering score \>= 2, folliculo-papillary conjunctivitis score \>= 2, number of fluorescein-stained punctuations \>= 10;
* Blepharitis, conjunctivitis, uveitis;
* Ocular laser treatment within the last 3 months;
* Ocular surgery, including LASIK and PRK, within the last 12 months;
* Topical ocular treatment during the last month;
* Ocular antibiotics within the last 7 days;
* Medication during the study (except paracetamol and contraceptives).
Pilates Exercise and Inhalation Injury Post Burn

Sixty patients with 25-45 years of age presenting post burn inhalation injury, randomly distributed into two equal groups, 30 patients for each group. control group receive conventional chest physiotherapy (diaphragmatic respiratory exercises, apical breathing exercises) for (15-20) minutes 3times/week and medical treatment for 4 weeks as a total period of treatment. study group will receive pilates exercise in addition to their conventional chest physiotherapy for (15-20) minutes 3times/week and medical treatment for 4 weeks as a total period of treatment, computerized spirometer assessment before treatment are ( The following variables were measured: forced vital capacity (PVC%) and forced ·expiratory volume in one second (FEVl %) and peak expiratory flow (PEF %)and after one month

Two groups of sixty patients (thirty patients in each group) of both sexes of inhalation injury post burn are selected randomly to participate in the study.

The patients will be divided into two equal groups in number:

* Group (A) study group: this group includes 30 patients who have postburn inhalation injury will receive conventional chest physiotherapy (diaphragmatic respiratory exercises, deep inhalation exercises, and respiratory exercises associated with shoulder flexion movements and extension of the upper limbs, assisted cough, circulatory exercises and early ambulation) and medical treatment and pilates method.
* Group (B) control group: this group includes 30 patients who have postburn inhalation injury will receive conventional chest physiotherapy (diaphragmatic respiratory exercises, deep inhalation exercises, and respiratory exercises associated with shoulder flexion movements and extension of the upper limbs, assisted cough, circulatory exercises and early ambulation) and medical treatment.
* computerized spirometer assessment before treatment are ( The following variables were measured: forced vital capacity (PVC%) and forced ·expiratory volume in one second (FEVl %) and peak expiratory flow (PEF %)and after one month

Eligibility Criteria:
Inclusion Criteria:

* Age ranged between 25-45 years.
* All patients presented post-burn inhalation injury.
* Patients with facial burn or upper limb burn.
* All patients would be free of acute or chronic pulmonary disease and will have the capacity to perform the protocol evaluation tests properly.
* All patients enrolled to the study would have their informed consent.

Exclusion Criteria:

* Cardiac diseases.
* Chronic pulmonary disorders.
* Previous or present smoking history.
* Female patients who are pregnant and lactating.
* Post-burn patient on ICU.
Electronic Pharmaceutical Record Used for Medication Reconciliation by a Pharmacist Associated to the Anesthesiologist Consultation

The objective is to evaluate the impact of an electronic pharmaceutical record used for medication reconciliation by a pharmacist associated to the anesthesiologist consultation

Experimental intervention:

medication reconciliation by a pharmacist using an electronic pharmaceutical record before the anesthesiologist consultation for planned surgery patients. The clinical pharmacist communicates the recommendations regarding the drug therapy to the anesthesiologist orally and using a specific formulary.

Control intervention:

Conventional anesthesiologist consultation for planned surgery patients.

Anesthesiology consultation is mandatory in France for planned surgery. It is part of the concept of anesthesia safety. The main goal is to assess the anesthetic and surgical risk including clinical and drug features likely to interfere with the anesthesia. The medication reconciliation is a central part of this consultation especially in order to assess the allergic risk and hemostasis disorders.

However, access to comprehensive and reliable data concerning the consumption of health products by the patient represents a major challenge. The "Dossier Pharmaceutique" (DP) is an electronic pharmaceutical record including medications (prescribed medications, over the counter medications, complementary and alternative medicines) delivered by community pharmacists over a four month period. Hospital pharmacists have access to the DP of hospitalized patients in order to improve the quality of the medication reconciliation. These informations regarding medication of the patients will be shared with anesthesiologists.

Eligibility Criteria:
Inclusion Criteria:

* patient coming for anesthetics consultation before a planned surgery
* age above18
* available electronic pharmaceutical record (DP)
* at least one medication prescribed before hospital admission

Exclusion Criteria:

* Minor patients ou majors protected by law
* Not speaking French patient
* Person who are not free by law or administrative decision
Patient-reported Outcomes of Donor Site Healing Using Different Palatal Protection Techniques

This study has been initiated to evaluate the question, "What is the best way to protect the palate after a gum graft is removed?" The overall objective is to determine if there is a difference in PROMs of donor site healing using different palatal post-operative protection techniques.

This study aims to determine if there is a difference in subject-reported outcome measures (PROMs) when different palatal post-operative protection techniques are used during healing after an autogenous soft-tissue graft is harvested from the palate for periodontal and peri-implant plastic surgery. The secondary objective is to evaluate if there is a difference in the healing of the palatal tissue via photographic and 3D linear and volumetric changes analysis after using the different protective techniques. Furthermore, the study will evaluate the time needed for fabrication and intraoral adjustment of each protective barrier and professional preference among the techniques utilized.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Healthy or Mild controlled systemic diseases with no functional limitations (ASA I or ASA II)
* Sites with 1 to 3 teeth or implants requiring soft-tissue grafting
* Minimum palatal thickness of 2 mm
* Willing to participate and sign an informed consent

Exclusion Criteria:

* Patients with systemic conditions that could impair wound healing (i.e. diabetes, immunosuppressive, chemotherapy, etc.)
* Pregnant patients
* Patients with bleeding disorders or taking anticoagulants
* Smokers
* Patients with a history of palatal graft harvesting
Long-term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients in Russia

EPICOR-RUS is a multi-centre, observational, prospective, longitudinal cohort study which will include patients, in a real-life setting, who are hospitalized for acute coronary syndrome (ACS) within 24 hours of symptom onset and who have a final diagnosis of Unstable Angina (UA), ST-Elevation Myocardial Infarction (STEMI) or Non-ST-Elevation Myocardial Infarction (NSTEMI). Patients will undergo clinical assessments and receive the standard medical care as determined by the treating cardiologist. Patients will not receive experimental intervention or experimental treatment as a consequence of their participation in the EPICOR-RUS observational study.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be 18 years of age or older of either gender or race
* Diagnosis of STEMI, NSTEMI or UA confirmed using the following definitions

Exclusion Criteria:

* UA, STEMI and NSTEMI precipitated by or as a complication of surgery, trauma, or gastrointestinal (GI) bleeding or post-Percutaneous coronary intervention (PCI).
* UA, STEMI and NSTEMI occurring in patients already hospitalized for other reasons.
* Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances).
* Already included in the EPICOR-RUS study.
* Presence of serious/severe co-morbidities in the opinion of the investigator which may limit short term (i.e. 6 month) life expectancy.
* Current participation in a clinical trial.