cyrilzakka/clinical-trials huggingface dataset:
Continuous Lidocaine Infusion for Management of Perioperative Burn Pain

Thermal injury results in one of the most intense and prolonged forms of pain the body can experience. Opioid narcotics are the most powerful drugs for acute and chronic pain, and their use in the perioperative period has been the mainstay of treatment; although medication requirements in burn patients are often underestimated. More medication may not be the answer, as relatively large doses of short acting opioids in the operative theater are associated with greater postoperative opioid consumption and higher pain scores. Furthermore, extensive use of opioids has resulted in the development of by hyperalgesia and allodynia. Lidocaine is an amide local anesthetic that has analgesic, anti-hyperalgesic, antiarrhythmic, and anti-inflammatory properties. Over the past 25 years, systemic lidocaine has been used for perioperative pain management in a variety of surgical procedures. The design of this study will examine if lidocaine will reduce the pain scores and narcotic utilization in patients undergoing surgical procedures for burn injuries. The intervention group will receive a bolus dose of lidocaine followed by a continuous infusion over 24 hours. The control group will get an equal volume of saline. The investigators will compare pain scores, opioid use, and narcotic equivalents based on body weight and burn surface area (BSA) grafted.


Eligibility Criteria:
Inclusion Criteria:

* Burn patient ≥ 18 years of age
* Burn patient scheduled to go to OR for excision and/or grafting procedure

Exclusion Criteria:

* Burn patient \< 18 years of age
* Intubated patient on sedation drip
* Prolonged hypotension defined as Systolic Blood Pressure (SBP) \< 90 mm/Hg for greater than 30 minutes in the pre-op area
* Severe underlying cardiovascular disease (documented ejection fraction \< 40%)
* Documented conduction block, bradycardia or active congestive heart failure
* Documented active gastritis or ulcers
* Previous steroid medication history if documented adrenal insufficiency
* Patient with documented liver disease
* Patient with epilepsy or known seizure disorder
* Pregnant Women
Telerehabilitation in Patients With Fibromyalgia

Sixty-six FMS patients received the same exercise program for 8 weeks and divided, synchronous (n: 33), asynchronous (n: 33). Pain (Visual analog Scale, VAS), functional limitations and disabilities (Revised Fibromyalgia Impact Questionnaire, FEA), health-related quality of life (HRQol; Short Form-12, SF 12), catastrophizing (pain catastrophizing scale, PCS), anxiety and depression (Hospital Anxiety and Depression Scale, HAD), functional capacity (6-minute walking test, 6MWT), muscle strength (Arm curl test) joint position sense (Laser Cursor Assisted Angle Repetition Test, LI-RATT) were assessed at baseline, mid-treatment (week 4), end of treatment (week 8), and eight weeks after treatment (week 16).

Materials and methods: A randomized clinical study. Sixty-six FMS patients received the same exercise program for 8 weeks and divided, synchronous (n: 33), asynchronous (n: 33). Pain (Visual analog Scale, VAS), functional limitations and disabilities (Revised Fibromyalgia Impact Questionnaire, FEA), health-related quality of life (HRQol; Short Form-12, SF 12), catastrophizing (pain catastrophizing scale, PCS), anxiety and depression (Hospital Anxiety and Depression Scale, HAD), functional capacity (6-minute walking test, 6MWT), muscle strength (Arm curl test) joint position sense (Laser Cursor Assisted Angle Repetition Test, LI-RATT) were assessed at baseline, mid-treatment (week 4), end of treatment (week 8), and eight weeks after treatment (week 16).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with FMS by the physician in accordance with ACR 2016 criteria,
* Having independent mobility,
* Not having advanced vision and hearing loss,
* Minimum literacy, participating voluntarily, making video calls, Internet and smartphone access

Exclusion Criteria:

* Have a rheumatic disease with more prominent symptoms than FMS,
* Have an active infection,
* Have a surgical operation in the last three months,
* Have an uncontrollable chronic disease,
* Have another musculoskeletal disorder
The Effect of Vitamin D on in Vitro Fertilization Outcome

To date, several studies have been done to explore the relationship between Vitamin D level and IVF outcome; however, the results are controversial. Sample sizes in these studies mentioned above were relatively small. In addition, there are no prospective cohort studies in this field. Thus, here the investigators carry this prospective observational cohort study to demonstrate the relationship between vitamin D level and IVF outcome.

Vitamin D level is measured before the commence of IVF cycle. According to Vitamin D level, patients are divided into 3 groups: A, Deficient, \<20 ng/mL; B, Insufficient, 20-29.9 ng/mL; C, Replete, \>30 ng/mL.

Ongoing pregnancy rate are compared among these three groups after controlling age, number of embryos transferred, ect.

In addition, Vitamin D level is also meassured before embryo transfer in FET cycles with PGT treatment. The effect of Vitamin D on IVF outcome is detected in patients transferred with Euploid embryos.

Eligibility Criteria:
Inclusion Criteria:

1. age between 21-40 years old
2. basal FSH hormone level less than 10 mIU/mL
3. the first cycle of IVF treatment with standard long protocol
4. both ovarian present and normal uterus.

Exclusion Criteria:

1. Important data missing
2. Gametes donation cycles
3. Anyone that does not meet the inclusion criteria
Molecular Profiling in Young (<50 Years of Age) Patients With Metastatic Breast Cancer

Breast cancer is the most common cancer in women worldwide, especially in developed countries. In developing countries, including South Korea, the incidence and mortality rate of breast cancer is rapidly increasing. One of the most important characteristics of breast cancer in South Korea, as well as in other Asian countries, is the younger onset of disease compared to Western.

Medical treatment of breast cancer is evolving rapidly, incorporating immune checkpoint blockades and molecularly targeted agents. However, data and knowledge are still limited in terms of molecular characteristics of Asian breast cancer, compared to that of Western countries, and this remains a major hurdle for drug development in Asian breast cancer patients.

The primary objective of this study is to elucidate the genetic characteristic of young (\<50 years of age) Korean patients with metastatic breast cancer using FoundationOne CDx.

Secondary Objective(s):

1. To evaluate the prognostic and predictive role of tumor mutation burden.
2. To reveal the correlation between genetic characteristics and immunohistochemical expression of selected proteins (including DNA damage repair (DDR) molecules and various immune modulating molecules including PD-L1, PD-1, IDO, and OX40).
3. Compare molecular characteristics of breast cancer according to age groups (\<35 years vs. 35-50 years).
4. To offer genomic profiling guided therapy to patients as early as possible (preferably, 1st- or 2nd-line of treatment). In addition, to explore how genomic profiling guided therapy could improve patient outcome as an ad-hoc if sufficient number of patients can be followed up (compared to historic data).

Eligibility Criteria:
Inclusion Criteria:

* Patients between 19 - 50 years of age on the day of signing informed consent.
* Able to provide written informed consent for voluntary participation in the trial.
* With metastatic breast cancer
* Willing to provide biopsies from the primary tumor or lymph nodes at screening to the central laboratory. (with at least 10 unstained slides and 1 H\&E slide)

Exclusion Criteria:

* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
Immunoglobulin Levels and Occurrence of Infections After Lung Transplantation and Impact of IgG Replacement

Immunosuppressive therapies have led to remarkable improvements in survival in lung transplantation (LT) patients. However, one important adverse effect of these therapies has been the increasing emergence of hypogammaglobulinemia (HGG) which has been previously seen mostly in patients with primary immunodeficiency (PID).

The goal of treatment of HGG in PID has been to maintain the trough IgG level above 500 mg/dl which might provide better protection against infections than do lower IgG serum concentrations. Although IgG therapy is of substantial benefit, the doses and trough levels of IgG that are optimal are not yet clearly established. The impact of high versus low IgG dosing on the frequency and severity of infections and rejection has not been studied before in LT patients with HGG. The specific aims for this study are to compare the incidence of infections in lung transplant recipients receiving higher versus lower dose of SQ IgG and to compare the incidence of infections in lung transplant recipients with mild hypogammaglobulinemia versus normal IgG levels. This study will be a single center study of all lung transplant recipients, age 18 years or older, at the University of Pittsburgh Medical Center (UPMC), with a randomized treatment arm and an observational arm.

The hypotheses for the research study are:

* Therapy with IV or SQ IgG is of substantial benefit in reducing the number of infections in lung transplant recipients with severe hypogammaglobulinemia (IgG \< 500)
* A higher dose of SQ IgG, with subsequent higher trough IgG levels, may have a higher impact on the frequency and severity of infections and rejection episodes, compared to a lower dose of SQ IgG, with subsequent lower IgG trough levels
* Lung transplant recipients with mild hypogammaglobulinemia ( IgG= 500-750) have a higher incidence of infections compared to patients with normal IgG levels


Eligibility Criteria:
Inclusion Criteria:

* adult recipients of lung transplantation at the University of Pittsburgh Medical Center, who are able to provide written informed consent prior to transplantation or on the day of lung transplant surgery.

Exclusion Criteria:

* age less than 18 years-old
* history of anaphylaxis to IVIG
* subjects already on IV or SQ IgG treatment
Immunogenicity and Safety of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Adults

The trial is a Phase II, open-label trial in healthy subjects aged 18 to 60 years to support the immunogenicity data from previous clinical studies.

Objectives:

* To describe the immune response 21 days after each vaccination.
* To describe the safety profiles following each vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 60 years on day of inclusion.
* Informed Consent Form signed.
* Able to attend all scheduled visits and to comply with all trial procedures.
* For a woman, inability to bear a child or negative urine pregnancy test.
* For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to and at least 4 weeks after each vaccination.

Exclusion Criteria:

* Systemic hypersensitivity to any component of the vaccine or a life-threatening reaction after previous administration of a vaccine containing the same substances (egg proteins, chick proteins, thimerosal, aluminum, neomycin, formaldehyde, and octoxinol 9).
* Febrile illness (oral temperature \>= 37.5°C) on the day of inclusion.
* Breast-feeding.
* Previous vaccination with an avian flu vaccine.
* Participation in a clinical trial (drug, device, or medical procedure) within 4 weeks prior to the first vaccination.
* Planned participation in another clinical trial during the present trial period.
* Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy.
* Chronic illness that could interfere with trial conduct or completion (e.g. cardiac, renal, diabetes, or auto-immune disorders).
* Current alcohol or drug abuse that may interfere with the subject's ability to comply with trial procedures.
* Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response.
* Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
* Planned receipt of any vaccine in the 4 weeks following any trial vaccination.
* Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Development and Validation of a Deep Learning-based Myopia and Myopic Maculopathy Detection and Prediction System

Myopia has become a global public health issue. Myopia affects the psychological health of children and adolescents and poses a financial burden. Therefore, early detection and prediction of children at a high risk of myopia development and progression are critical for precise and effective interventions. In this study, we developed a deep learning system DeepMyopia, based on fundus images with the following objectives: 1) to predict myopia onset and progression; 2) To detect myopic macular degeneration for AI-assisted diagnosis; 3) To predict the development of myopic macular degeneration; 4) evaluate its cost-effectiveness.

Myopia has become a global public health issue. Myopia affects the psychological health of children and adolescents and poses a financial burden. Furthermore, as myopia progresses it increases the risk of ocular complications such as myopic macular degeneration, leading to irreversible visual impairment or even blindness. According to the World Health Organization , more than 1 billion people worldwide are living with vision impairment caused by myopia, hyperopia, and other problems due to late detection. Therefore, early detection and prediction of children at a high risk of myopia development and progression are critical for precise and effective interventions.

In this study, we developed a deep learning system DeepMyopia, based on fundus images with the following objectives: 1) to predict myopia onset and progression; 2) To detect myopic macular degeneration for AI-assisted diagnosis; 3) To predict the development of myopic macular degeneration; 4) evaluate its cost-effectiveness.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with fundus images in the Shanghai Child and Adolescent Large-scale Eye Study (SCALE) ;
2. Subjects with fundus images in the Shanghai Time Outside to Reduce Myopia \[STORM\] trial;
3. Subjects with fundus images in the High Myopia Registration Study \[SCALE-HM\]
4. Subjects with fundus images in the Shanghai Myopia Screening (SMS) Study;
5. Subjects with fundus images in the Beijing Children Eye Study
6. Subjects with fundus images in the First Affiliated Hospital of Kunming Medical University;
7. Subjects with fundus images at the Ophthalmology Department of the First Affiliated Hospital of Xinjiang Medical University;
8. Subjects with fundus images at the Ophthalmology Department of the Affiliated Hospital of Inner Mongolia Medical University;
9. Subjects with fundus images at Zhongshan Eye Centre, Sun Yat-sen University;
10. Subjects with fundus images in the Hong Kong Children Eye Study;

Exclusion Criteria:

* Participants with poor-quality fundus images
Optimizing Walking Function of Stroke Survivors by a Task-Oriented Home Exercise Program

In a randomized-controlled study, the effects of a structured, progressive, task-oriented home exercise program to optimize walking competency will be evaluated in subacute stroke survivors.

The majority of stroke individuals unable to reenter their previous community life after they have had a stroke. Reintegration of community life by optimizing walking function is a major goal of stroke rehabilitation. Because not widely available inpatient rehabilitation, discharged with incomplete recovery, limited numbers of technically trained physical therapists, financial saving, and transportation difficulty, home-based stroke rehabilitation setting has been interested in many developing countries.

Task- oriented exercise is well known and accepted approach to optimize walking function with underlying principles of motor control and motor learning theories. This approach has been used in the clinical setting with close supervision, but identification of appropriate protocol in the community environment is on progress. To date, no proper home exercise program based on task-oriental principle with minimal supervision for improving walking competency after stroke has been proposed in stroke rehabilitation.

The purpose of this study is to investigate the effects of a structured, progressive, task- oriented home exercise program on walking competency in individual post stroke.

Eligibility Criteria:
Inclusion Criteria:

1. Either side of both type first stroke within 2 weeks to six months of onset with confirmatory diagnosis by CT Scan and MRI.
2. Age between 40 to 65 years old.
3. Moderate severity of stroke measured by the modified Rankin Scale (mRS- 3)
4. Able to comprehend the instructions with good cognition measured by Mini-Mental State Examination (MMSE \> 23).
5. Postadoption stage of readiness to change measured by the Stages of Change Questionnaire (stage 4 and 5)

Exclusion Criteria:

1. Diagnosed with other neurological disorder such as Parkinson's disease, peripheral nerve injury.
2. Serious cardiac conditions (angina and myocardial infarction during the previous month, resting heart rate of more than 120, a systolic blood pressure of more than 180 mm Hg, and a diastolic blood pressure of more than 100 mm Hg)
3. Fugl Meyer Assessment score (lower extremity) less than ≤ 21
4. Significant hip, knee and ankle contracture that would limit ambulation (Fugl Meyer (ROM) ≤1 in each joint).
5. Orthopedic and rheumatological disorder with weight bearing pain (Fugl Meyer (pain) ≤ 1 in hip, knee and ankle joint movement).
Diagnostic Value of Ultra-low Dose Thoracic Scanner for the Pulmonary Arteriovenous Malformation Detection in HHT Patient

Hereditary hemorrhagic telangiectasia (HHT) is linked to a dysregulation of angiogenesis leading to the formation of arteriovenous malformations (AVM): cutaneo-mucous telangiectasia and visceral shunts. The diagnosis is clinical and based on Curaçao criteria: recurrent epistaxis, cutaneo-mucous telangiectasia, hereditary signs and presence of visceral AVM.

Pulmonary AVMs (PAVM) expose patients to many potentially life-threatening complications, such as strokes or brain abscesses due to the right-left shunt created and the lack of filtration barrier of the pulmonary capillary within the AVM. These patients should therefore have regular monitoring throughout their life by a chest CT scanner every 5 to 10 years in the absence of PAVM at the initial scan or more often if PAVMs are present. The management of PAVMs is based on their early detection and embolization in interventional radiology during which is set up within the afferent artery of the PAVM an embolizing agent, the coil.

However, the risk of cumulative irradiation exposure from thoracic scanners and repeated thoracic embolizations over time could be reduces by a decrease of X-rays dose.

A new thoracic CT imaging protocol validated in the United States in the primary screening of lung cancer, the ultra-low dose protocol, is a CT scanner acquired at an irradiation dose equivalent to that of a frontal chest x-ray and in profile. The dose reduction is of 40 times the usual dose of a chest CT scanner.

The lung parenchyma has a high natural contrast on thoracic CT images and there are few adjacent attenuating structures allowing a drastic reduction of dose. However, from this dose, the image quality is degraded with an increase of the image noise. The diagnostic performances have to be confirmed with qualitative and quantitative measurements.

Thus, the objective of this study is to compare the sensitivity and the specificity of the current scanner and the ultra-low dose scanner to reduce the exposure to X-rays.


Eligibility Criteria:
Inclusion Criteria:

* Patient monitored for a clinically confirmed Rendu-Osler disease and / or confirmed by molecular biology, seen for an initial assessment or for a reassessment of PAVM (after treatment or without treatment)
* Patient who agreed to participate in the study and signed the written informed consent
* Patient affiliated to a social security scheme or similar

Exclusion Criteria:

* Women who are pregnant, nursing (lactating) or at risk of pregnancy (verified by a urine test before performing the scanner)
* Patient who is protected adults under the terms of the law (French Public Health Code).
* Patient who has not or poorly understand French
Electromyography for Diaphragm Effort

Mechanical ventilation may be necessary to save the life of a patient due to an accident, pneumonia or surgery. The ventilator then temporarily takes over the function of the respiratory muscles. During treatment in the Intensive Care, the amount of support provided by the ventilator is usually lowered gradually, until the point that the patient can breathe unassisted once again. However, in a large fraction of patients (up to 40%) it takes days to weeks before the patient is able to breathe unassisted, even after the initial disease has been treated. This is called prolonged weaning.

A possible cause of prolonged weaning is weakness of the respiratory muscles. The diaphragm, the largest respiratory muscle, can become weakened if it is used too little, much like all other muscles in the body. Additionally, damage and weakness of the diaphragm can occur when the diaphragm has to work excessively. Therefore, it is important that the diaphragm works enough; not so little that it becomes weakened, but not too much either.

Measurements of pressure generated by the diaphragm are needed to determine the current level of diaphragm activity in a patient on mechanical ventilation. However, these measurements are rarely performed, because they are time-consuming and require placement of two additional nasogastric catheters. This is a shame, as adequate loading of the diaphragm might prevent development of weakness, leading to shorter duration of mechanical ventilation. Finding alternative measurements of diaphragm effort might be a solution to this problem.

It has been hypothesized that the electrical activity of the diaphragm provides a reliable indication of diaphragm effort. This study aims to determine whether there is a correlation between pressure generation by the diaphragm and electrical activity of the diaphragm over a wide range of respiratory activity, from low effort to extreme effort, in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* Age \>18 years

Exclusion Criteria:

* History of cardiac and/or pulmonary disease or current medication use
* History of pneumothorax
* Contra-indications for nasogastric tube placement (recent epistaxis, severe coagulopathy, current upper airway pathology)
* Contra-indication for magnetic stimulation (cardiac pacemakers or metal in cervical area)