cyrilzakka/clinical-trials huggingface dataset:
Aerosolized Albuterol Use in Severe BPD

Currently several dose schedules of Albuterol are administered via nebulization to infants in the neonatal and infant intensive care unit (N/IICU). As Albuterol is not FDA approved for this population (under 2 years) there is no standard recommended dose. Aerosolized Albuterol is one of the most widely used therapies that are utilized for infants with chronic lung disease. The common practice in the N/IICU is weight base dosing of all medications. This contradicts the aerosol science recommendations, which advise not to titrate doses by weight as the patient naturally self-regulates their dose according to the change in minute ventilation with age. In addition, the wide use of aerosolized Albuterol in the infant with Bronchopulmonary Dysplasia (BPD) has little current evidence of efficacy in this disease. Understanding the appropriate dose for effective treatment as well as the indication for use in the BPD population would provide the clinician with useful guidelines.

The investigators propose to analyze the safety and efficacy of aerosolized albuterol in infants with BPD comparing the recommended dose per aerosolization literature with the common dosing practices at The Children's Hospital of Philadelphia (CHOP) as well as placebo.

This is a randomized, blinded cross-over study of infants with a diagnosis of Severe BPD that are mechanically ventilated. Participants will receive 3 sets of treatment (2.5mg Albuterol, 1.25mg Albuterol, 3ml normal saline placebo), in random order. Each treatment will be administered every 4 hours for 24 hours. After a 6 hour washout phase, the next group of interventions will be applied. Following another wash-out phase, the final group of intervention will be applied. Pulmonary mechanics from the ventilator (e.g. airway compliance, airway resistance, tidal volume, peak inspiratory pressure, Forced Expiratory Flow at 75% of forced vital capacity, etc.) and the patient short term response to therapy (heart rate, blood pressure, heart rhythm) will be assessed for the duration of the treatment period.

Eligibility Criteria:
Inclusion Criteria:

1. Infants greater than or equal to 36 weeks corrected gestational age to one year of age
2. Diagnosis of BPD in accordance with The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) definition
3. May have a current order for short acting bronchodilator, not required
4. May have congenital anomalies unless one or more of the exclusion criteria are met, not required
5. Receiving conventional mechanical ventilation via an artificial airway (endotracheal tube or tracheostomy) via Draeger V500 Ventilator
6. Parental/guardian permission (informed consent)

Exclusion Criteria:

1. Airway leak greater than 10%
2. Unilateral lung disease
3. Current order for inhaled anticholinergic (i.e. ipratropium bromide)
4. Active pulmonary or systemic infection
5. Scheduled order for other medication that cause bronchodilation (i.e. atrovent, magnesium sulfate, ketamine, etc.)
The Role of Gut Microbiome and Chronic Inflammation in Young-onset Colorectal Cancer

This study aims to investigate the role of gut microbiome pattern and inflammation marker NF-ҡB in young-onset colorectal cancer


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 35 years old
2. Suspected with colorectal cancer and undergoing a colonoscopy procedure
3. No history of colorectal cancer treatment

Exclusion Criteria:

1. Unwilling to provide fecal and blood sample
2. Incomplete colonoscopy procedure due to any reasons
Operative Mitral Valve Reconstruction in Functional mv Insufficiency With Reduced Systolic Ventricle Function

Functional mitral insufficiency poses a challenge with regard to the optimal time of intervention, particularly because they are frequently associated with left ventricular (LV) dilation and reduced LV ejection fraction (EF). The registry will document the underlying pathology by using transthoracal echo cardiography (TTE) with analysis of common tenting parameters. OP strategies, data and outcomes will be documented, as well as follow-up data for echocardiography, quality of life and MACCE outcomes after 6 months, 1 and 2 years.

Prospective enrolment of all patients with mitral valve insufficiency and restricted movement of leaflets during systole into a multicentric registry. Exact analysis of the underlying pathology using TTE with analysis of tenting parameters. In patients without contraindications, functional preoperative MRT to determine the functional reserve of ventricular function. Documentation of the quality of life of the patients using the SF12 questionnaire before and after intervention. Documentation of follow-up data (SF12, TTE, NT-pro BNP) at 6 months, 1 and 2 years. Development of operative strategies to improve long-term outcomes in patients with severe LV dilation (typically accompanied by function mitral insufficiency type IIIb).

Eligibility Criteria:
Inclusion Criteria:

* functional mitral valve insufficiency with reduced mobility of leaflets during systole (type IIIb) - effective regurgitation orifice area \> 20 mm2 / regurgitant volume \> 30 ml/beat
* left ventricular ejection fraction \<= 50% and /or left ventricular end-diastolic diameter \>= 60 mm
* tenting of the proximal and / or anterior mitral leaflets

Exclusion Criteria:

* prolaps of leaflets (type II mitral regurgitation)
* combination intervention with aortic valve repair or replacement
* re-operation at mitral valve
Efficacy of New Silver-coated Prosthesis in Reducing the Incidence of Periprosthetic Infections

The aim of the present clinical study, of prospective observational nature with biological study, is to conduct a clinical investigation on the the efficacy of a device coated with bacteriostatic silver coating, with the overall objective of understand whether the device is indeed able to reduce the number of peri-operative and post-operative infections, both early and late.

Among the various complications that can arise in orthopaedics following implant surgery, peri-prosthetic joint infections (Periprosthetic Joint Infection -PJI) represent one of the most feared complications and the main cause of revision surgeries (15% and 25% of hip and knee revision surgeries, respectively). In this complex context, prevention therefore plays a fundamental role and is a key objective considering the increasing number of patients considered to be at high risk such as the elderly, patients with recurrent infections (urinary, pulmonary, etc.), those suffering from diabetes mellitus or obese, the immunocompromised, or patients who have already undergone prosthetic surgery.

In order to reduce the risk of infection, it is therefore essential to adopt and implement preventive strategies that also involve the medical devices themselves, such as the development of passive surfaces capable of counteracting bacterial adhesion or active surfaces capable of exerting a direct action on micro-organisms. To achieve this second type of action, antibacterial agents, such as silver, known for its antimicrobial and bactericidal properties, are used.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years;
* Immunocompromised patients and/or diabetic patients.
* Patients who have given consent

Exclusion Criteria:

* Patients aged \< 18 years;
* Pregnant women;
Development of a Keratoconus Detection Algorithm by Deep Learning Analysis and Its Validation on Eyestar Images

Monocentric clinical study to develop an imaging analysis algorithm for the Eyestar 900 to identify keratoconus corneas and improve biometry for intraocular lens calculations

Keratoconus is a progressive corneal ectatic disorder, characterised by thinning, protrusion and irregularity. Corneal imaging is crucial in keratoconus detection and progression analysis. Detection of keratoconus in early stages is important and has therapeutic consequence, whether to plan a surgical intervention or calculating an intraocular lens, before cataract surgery, as standard lens calculation techniques may lead to wrong results in patients with a keratoconus.

The Eyestar 900 is a swept-source OCT biometer and has the potential to be used for early keratoconus identification and progression analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with all stages of keratoconus
2. Patients with healthy corneas

Exclusion Criteria:

1. Keratoconus patients with hydrops, status following hydrops
2. Patients with degenerative corneal diseases
3. Patients after corneal surgery
A Study of tDCS for Swallowing Difficulties in Stroke Patients

The primary objective of this study is to investigate whether the dual transcranial direct current stimulation(tDCS) improves the swallowing function of stroke patients.

120 patients were recruited and randomized to receive either real or sham-tDCS. Real experimental groups were divided into three types; Anode-Anode dual stimulation group, Anode-Cathode dual stimulation group, Single stimulation group. 20-minutes session of the stimulation were applied 5 times a weeks for 2 weeks at pharyngeal motor cortex of affected or non-affected site. The patients were evaluated at baseline, immediately and 2 weeks after tDCS.

Eligibility Criteria:
Inclusion Criteria

* Subjects who have diagnosed as primary stroke by physician's physical exam or radiologic diagnosis
* Subjects who have cortical or subcortical brain lesion
* Subjects who was diagnosed as stroke within 6 months
* Subjects ages from 18years to 80years old
* Subjects who have less than 5 points of DOSS score due to swallowing difficulty from CNS injury
* Subjects who is possible to receive swallowing function intervention 5 days a week
* Subjects who understand the purpose of the study and acquired the consent of the patient or caregiver
* Subjects who had no effect from brain stimulation or electrical stimulation therapy

Exclusion Criteria

* Subjects who have pre-existing and active major neurological disease
* Subjects who have pre-existing and active major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia
* Subjects who have brain lesion except cortex or subcortex area
* Subjects who have any metal component after brain surgery, low threshold to pain, history of seizure
* Subjects who is estimated as not appropriate for the study by the investigators
A Clinical Study of Tranilast in the Treatment of Cryopyrin-Associated Periodic Syndrome (CAPS)

This is a prospective cohort study to observe the efficacy and safety of tranilast in CAPS patients. The investigators would analyze the changes in Auto-Inflammatory Diseases Activity Index (AIDAI) before and after treatment as well as changes in inflammatory markers, patients' and physician's global assessment of disease activity to determine the efficacy and safety of tranilast.

Seventy-one patients with CAPS will be recruited. After signing the informed consent, they will be administrated with tranilast (For juvenile patients, 5mg/kg.d with a maximum dose of 0.3g per day; For adult patients, the dose is 0.1g each time, three times a day). These patients will be followed up for 6 months. AIDAI is recorded by patients' or their parents one month before the start of treatment, and at the 1st, 3rd and 6th month after the treatment. Inflammatory markers, and patients' and physician's global assessment of disease activity will be assessed during the 1st, 3rd and 6th month follow-up. Side effects will be monitored and recorded as well. Experimental data before and after the administration of tranilast will be analyzed and be statistically processed, to figure out whether tranilast is effective and safe for CAPS patients.

Eligibility Criteria:
Inclusion Criteria:

* All patients must meet the following diagnostic criteria of CAPS and have pathogenic mutation(s) in NLRP3 gene.

  1. Raised inflammatory markers (CRP/SAA) (mandatory criteria)
  2. ≥2 of 6 CAPS typical signs/symptoms:

     1. Urticaria-like rash;
     2. Cold/stress triggered episodes;
     3. Sensorineural hearing loss;
     4. Musculoskeletal symptoms (arthralgia/arthritis/myalgia);
     5. Chronic aseptic meningitis;
     6. Skeletal abnormalities (epiphyseal overgrowth/frontal bossing).

Exclusion Criteria:

* Patients will not be included if meets any of the following criteria:

  1. Being treated with IL-1 inhibitor, other biological agents and immunosuppressants
  2. Pregnant and lactating women
  3. Serious organ function failure, expected life time less than 6 months
Impact of Maternal COVID-19 Disease on Breast Milk and Infant Health

prospective multicenter study The main aim is to study the impact of maternal COVID-19 on breast milk immune, microbiological, and metabolic profile and infant growth and development


Eligibility Criteria:
Inclusion Criteria:

* pregnant or nursing women with positive PCR for SARS-CoV-2 in nasopharynge and/or presence of SARS-CoV-2 antibodies in serum determined in hospitals

Exclusion Criteria:

* aggravation of symptomatology requiring specific treatment and/or hospitalization
End-eXpiratory Occlusion Test to Predict fluId REsponsiveness in the Operating Room (EXPIRE)

The purpose of the study is to evaluate the influence of different durations of the end-expiratory occlusion test to predict fluid responsiveness in mechanically ventilated patients in the operating room.

The reduction of postoperative complications is an essential aspect of care in perioperative medicine.

Many studies have shown that individualized hemodynamic therapy, by optimizing fluid administration and cardiac output, can reduce the risk of postoperative morbidity and mortality.

A fluid challenge, consisting in the administration of a small bolus of intravenous volume of fluid over a short period of time, is one of the commonest therapeutic hemodynamic intervention to test the preload reserve and the cardiac response to an increase in intravascular volume of a patient (fluid responsiveness). However, an increase in stroke volume (or cardiac output) is only achieved in 30 to 50% of patients after a fluid challenge test. Several dynamic tests have been described to predict the response to fluid challenge, however their limits are numerous.

The end-expiratory occlusion (EEO) test, consisting in a brief interruption of mechanical ventilation at end-expiration, by preventing the variation in intra-thoracic pressure, allows an increase in venous return, cardiac preload and stroke volume. Thus, an increase in stroke volume during an EEO can predict fluid responsiveness, simulating a fluid challenge though avoiding the administration of possibly unnecessary fluids.

The EEO test has already been successfully evaluated in several studies in ICU patients. Only few studies were conducted in the operating room, with conflicting findings: one study, consisting of an EEO test of 30 seconds found that changes in stroke volume during an EEO can predict fluid responsiveness, whereas another one, consisting of an EEO test of 15 seconds did not.

The purpose of the study is to evaluate the influence of the duration of EEO test to predict fluid responsiveness in mechanically ventilated patients in operating room.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age \>18 years)
* Scheduled to undergo planned surgery under general anesthesia
* Surgery requiring invasive arterial and stroke volume monitoring
* Clinical indication to perform a fluid challenge
* Patients able to give informed consent
* Affiliated to a social security scheme

Exclusion Criteria:

* Patient refusal to participate or inability to provide informed consent
* Protected major
* History of lobectomy or pneumectomy
* Patient with reduced left (ejection fraction \< 45%) or right ventricular systolic function
* Arrythmia
* Severe valvulopathy
* Body Mass Index \<15 or \> 40kg/m2
* Contraindication to insertion of invasive arterial line into radial artery
* Emergency surgery
* Pregnancy
IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease

This is a single center, open-label, prospective, investigation to quantify the effects liver congestion and fibrosis has on hepatic drug metabolism and transport in children, adolescents, and young adults with Fontan circulation.


Eligibility Criteria:
Inclusion Criteria:

* \> 8 years
* Status Post Fontan Completion
* Ability to provide informed permission-assent (\<18 years) or consent (≥18 years)
* Fasting overnight (\~8 hours)

Exclusion Criteria:

* Pregnancy
* Non-fasting
* Non-removable metal in body or where magnetic resonance imaging (MRI) is considered unsafe
* Sildenafil and/or Pravastatin therapy within last 2 months
* History of underlying or laboratory evidence of underlying intestinal, metabolic, autoimmune, renal disease that can alter Sildenafil and Pravastatin disposition (absorption, metabolism, distribution, or clearance)
* Pharmacotherapy that interacts with Sildenafil (cytochrome P450 3A4 and P450 3A5 (CYP3A4/5) inducers/inhibitors) and/or Pravastatin (organic anion transporting polypeptide (OATP1B1) inducers/inhibitors)
* Inability to swallow a tablet
* \>5X the age-specific upper limit of normal for aspartate aminotransferase (AST) and alanine aminotransferase (ALT), total and conjugated bilirubin
* Diarrhea in the last 24 hours \*History of solid organ transplantation
The Effect of Doppler Ultrasound on Calcified Tendinitis

Calcific tendinitis of the shoulder, is a self-limiting disease characterized by the deposition of calcium phosphate crystals in the rotator cuff tendons. Patients will develop complications such as decreased range of motion of the shoulder joint, and thus reducing their quality of life. The most common site of occurrence is 1.5-2 cm away from the supraspinatus tendon insertion site on the greater tuberosity. The primary treatment for calcific tendinitis is conservative, such as non-steroidal anti-inflammatory analgesics for pain relieving, extracorporeal shock wave therapy, subacromial steroid injections, ultrasound-guided barbotage technique for aspirating and washing out calcific deposits. Ultrasound is being used in calcified tendinitis for evaluating its size, location, quality, and also using the color Doppler ultrasonography to evaluate its reactive inflammatory changes. However, the use of color Doppler ultrasonography in diagnosing and treating a shoulder pain with calcification is not being concluded yet. Therefore, the aim of this study is to evaluate the efficacy of color Doppler ultrasonography in calcified tendinitis.

Purpose: To evaluate the efficacy of color Doppler ultrasonography in calcified tendinitis.

Eligibility Criteria:
Inclusion Criteria:

1. chronic shoulder pain for more than 1 month
2. shoulder X-ray showed calcified deposit

Exclusion Criteria:

1. patient with needle phobia
2. patient with known allergy to medication like Triamcinolone and Lidocaine
A Study to Investigate the Effect of SFF on Glucose and Insulin Responses

This goal of this clinical study is to investigate the postprandial glycemic and insulinemic response in healthy adults after the consumption of:

1. Sugars from Fiber in comparison with dextrose
2. Sugars from Fiber incorporated into chocolate chips in comparison with regular chocolate chips


Eligibility Criteria:
Inclusion Criteria:

1. Individuals, 20-65 years of age, inclusive.
2. Body mass index (BMI) between 19 and 35 kg/m², inclusive, at screening.
3. Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
4. Willing to maintain current dietary supplement and non-exclusionary medication use throughout the trial.
5. Willing to avoid the consumption of alcohol, unusual food intake, and unusual physical activity 24h prior to each study visit. Failure to follow will result in rescheduled visit.
6. Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected. health information to the study investigator.

Exclusion Criteria:

1. Failure to meet any one of the inclusion criteria.
2. Known history of gastrointestinal disease (e.g., diverticulitis, Crohns disease, coeliac disease etc.), bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, or biliary diseases, or any condition which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
3. Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
4. Major trauma or surgical event within 3 months of screening.
5. Unwillingness or inability to comply with the experimental procedures and to follow INQUIS safety guidelines.
6. Known intolerance, sensitivity or allergy to test foods.
7. Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.).
8. History of cancer in the prior two years, except for non-melanoma skin cancer.
9. Exposure to any non-registered drug product within 30 d prior to screening.
10. Self-reported pregnancy or breastfeeding.
JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation

The purpose of this registry is to observe longterm performance and safety of the JenaValve TAVI system, in routine medical and everyday conditions.

The objective of this study is to evaluate the long term safety and effectiveness of the CE-marked JenaValve System Transapical in an elderly patient population with severe aortic stenosis and/or aortic insufficiency who are at high risk for open surgical aortic valve replacement.

The target study population will consist of elderly patients suffering from severe symptomatic degenerative aortic valve stenosis and/or aortic insufficiency who show an increased risk for an open aortic valve replacement surgery due to existing co-morbidities.

Eligibility Criteria:
Inclusion Criteria:

* Patients suitable for TAVI with the JenaValve according to instructions for use

Exclusion Criteria:

* Patients unsuitable for TAVI with the JenaValve according to instructions for use
A Survey of Hospitalizations in Cardiology Units in Sub-Saharan Africa

FEVRIER study is an observatory of hospitalizations in cardiology units in sub-Saharan Africa.

FEVRIER is an observational study based on a questionnaire completed by investigators for each hospitalization in cardiology unit during the month of February.The investigator is a physician of the participating hospital.

FEVRIER evaluates the modalities of care management. It will take place in cardiology units of hospitals of sub-Saharian countries one month per year (month of February) during 5 years.

The investigator will thoroughly complete:

* one information form describing the hospital and the department
* one questionnaire (2o questions) for each hospitalized patient

Patients with at least one day of hospitalization will be enrolled in the study. On the first day of February, all patients already hospitalized will be enrolled and all patients hospitalized in the last day of February will be followed until their discharge. thus, data collection will start 1st day of investigation, during February and will continue until the discharge of the last enrolled patient.

Eligibility Criteria:
Inclusion Criteria:

* to be hospitalized in a cardiology department of a participating center during the month of February

Exclusion Criteria:

* refusal