cyrilzakka/clinical-trials huggingface dataset:
Diaphragm Ultrasound Vs Transpulmonary Pressure To Set PEEP in ARDS

This is a proof of concept study where the investigators aim to study the correlation between the use of a simple bedside ultrasound measurement of diaphragmatic muscle excursion with established (but time consuming) measurements made to optimize an important setting on the mechanical ventilator (positive end expiratory pressure or PEEP) in intubated adults with acute respiratory distress syndrome (ARDS) in the medical ICU.

Ventilator induced lung injury (VILI) generates morbidity and mortality in mechanically ventilated patients. The awareness of respiratory mechanics is essential in the prevention of VILI. Currently, plateau pressures are widely used as a guide to assess alveolar pressure and minimize alveolar injury. However, patients with reduced chest wall compliance can have higher plateau pressures that may not reflect true alveolar pressure. The transpulmonary pressure has been cited as the true alveolar driving pressure because it takes into account pleural pressure that reflect chest wall mechanics; however, this requires measurement of esophageal pressure.

The investigators have experienced a disproportionate degree of excursion between the posterior and anterior right hemidiaphragm on bedside ultrasound imaging in patients with ARDS, which may reflect the dependent atelectasis that occurs during low tidal volume ventilation, cardiac weight, weight of injured lung and accumulation of extravascular lung water in critically ill patients. The optimal PEEP can be guided by measurement of esophageal pressure (and subsequent calculation of transpulmonary distending pressure) with a balloon catheter placed into the esophagus much like a nasogastric tube for enteral access. The investigators believe that the normalization of the disproportionate degree of excursion between the anterior and posterior diaphragm can also be used to identify optimal PEEP, and may be correlated with changes in transpulmonary pressure (the current gold standard).

Eligibility Criteria:
Inclusion Criteria:

* Adults older than 18 years old who develop ARDS, as defined by the Berlin criteria, within 72 hours of ICU admission.

Exclusion Criteria:

* Any contraindication for nasogastric tube placement including recent injury or pathologic condition of the esophagus.
* Major bronchopleural fistula.
* Solid organ transplant recipient.
* History or current diagnosis of diaphragmatic paralysis.
* Non-conventional mechanical ventilation strategy including high frequency oscillation, airway pressure release ventilation, prone ventilation and extra- corporeal membrane oxygenation.
* Hemodynamic instability defined as MAP\<65 with multiple vasopressors.
* Declining to sign consent form.
Predictors of Pulmonary Hypertension in Patients With Advanced Lung Diseases

First, the aim of the study was to evaluate the usefulness of echocardiographic parameters for detecting pulmonary hypertension (PH) in patients with advanced lung disease referred for lung transplantation. Second, to assess the prevalence of PH and to identify which hemodynamic, echocardiographic, pulmonary functional test, exercise capacity and biochemical parameters (especially NT-proBNP) have an impact on survival in a cohort of patients with severe lung diseases referred for lung transplantation.


Eligibility Criteria:
Inclusion Criteria:

* advanced lung disease
* qualification for lung transplantation
* written informed consent
* pulmonary capillary wedge pressure \< 15 mmHg

Exclusion Criteria:

* cancer,
* history of idiopathic pulmonary hypertension,
* primary valvular heart diseases,
* coronary artery disease,
* collagen vascular disease,
* history or evidence of left ventricular dysfunction,
* atrial fibrillation,
* increased liver enzyme levels ( 3 times the upper laboratory limit),
* renal dysfunction (estimated glomerular filtration rate \< 60 ml/min/1.73m2)
* patients who didn't write the personal informed consent
* any specific therapy for PH.
Impact of Immediate Versus South African Recommendations Guided ART Initiation on HIV Incidence

This trial is evaluating a public health intervention strategy trial which aims to reduce the incidence of HIV at a population-level.

The proposed strategy is a two steps process:

* Extensive HIV counselling and testing, and comprehensive prevention programme among a target population
* Immediate ART initiation after HIV diagnosis, irrespective of CD4 count criteria.

The underlaying trial hypothesis is that HIV testing followed by immediate ART initiation of all HIV-infected individuals will prevent onward transmission and reduce HIV incidence in the population. This is a cluster randomised controlled trial with a total of 22 communities used as the units for randomisation. Enrolment of a population of 22 000 individuals among which 4 400 are expected to be HIV-Infected.

The trial objective is to estimate the effect of ART initiated immediately after HIV diagnosis on the reduction in incidence of new HIV infections in the general population. It will be conducted in two phases:

* First phase: aiming to evaluate the feasibility and acceptability of extensive HIV testing and early ARV treatment initiation on a subset of the target population (Hlabisa sub-district in KwaZulu Natal, South Africa); completion on February 2014.
* Second phase: full implementation of the trial in the target population from May 2014.

The proposed intervention has two components :

* Component 1 "Test": HIV counselling and testing, and comprehensive prevention programme among the entire target population
* Component 2 "Treat": ART treatment initiation for HIV infected individuals following two strategies

  * control group: ART initiation when eligible for treatment as per WHO guidelines
  * intervention group: immediate ART initiation regardless of immunological and clinical staging

Eligibility Criteria:
Inclusion Criteria:

* Aged 16 and more
* Member of a household in the designated cluster within the Hlabisa sub-district of KwaZulu Natal in South Africa
* Able and willing to give written informed consent for trial participation and/or HIV counselling and testing
Inhibin B/AFC Ratio for Ovarian Response

Ovarian response to gonadotropin stimulation plays a major role in the success of in vitro fertilization (IVF). Anti-müllerian hormone (AMH), inhibin B, and antral follicle count (AFC) are ovarian reserve markers and also predictors of the ovarian response, as they correlate with the number of oocytes retrieved. Ovarian responsiveness can also be assessed through the Follicular Output Rate (FORT), which evaluates the proportion of follicles that developed during stimulation by the ratio of PFC (preovulatory follicle count) to AFC. FORT highlights that some follicles do not respond to the FSH; therefore, this project proposes an endocrinological approach to this issue by relating AFC to inhibin B and AMH ㅡ hormones produced by granulosa cells, but at different stages of folliculogenesis and with endocrine and paracrine functions, respectively. The inhibin B/AFC and AMH/AFC ratios correlated with FORT and the number of oocytes retrieved may help elucidate the mechanisms involved in follicular responsiveness.

A prospective cohort study will be conducted with patients of the Insemine Center for Human Reproduction. Antral follicle count and AMH measurement will be performed before IVF cycle initiation, and inhibin B measurement will be carried out on a blood sample collected on the fifth day of ovarian stimulation. The primary outcomes will be the Follicular Output Rate (FORT) and the number of oocytes retrieved. Secondary outcomes include the number of metaphase II oocytes, oocyte quality, fertilization rate and embryo quality.


Eligibility Criteria:
Inclusion Criteria:

* first IVF;
* without severe male factor involved.

Exclusion Criteria:

* Patients with endometrioma;
* ovarian cyst;
* AMH \< 0.5 ng/ml;
* increased serum TSH (thyroid-stimulating hormone) or prolactin levels;
* endocrinopathies;
* previous oophorectomy;
* failure to visualize one of the ovaries on ultrasound.
Biological Effects of Quercetin in COPD Phase II

This study determines whether quercetin supplementation reduces the inflammation and oxidative stress markers in patients with chronic obstructive pulmonary disease. It is small study with 8 subjects receiving quercetin 1000 mg/day, 8 patients receiving 500 mg/day and 4 subjects receive placebo.

Chronic obstructive pulmonary disease (COPD) is a progressive lung disorder and affects millions of people globally. Although the exact mechanisms of pathogenesis of this disease are not well-understood, the general consensus is that oxidative stress and inflammation induced by exposure to cigarette smoke or other environmental or occupational hazards are responsible for development of COPD. Therefore, therapies aimed at decreasing oxidative stress and inflammation constitutes an important component of treating COPD.

The current pharmacological therapies may provide temporary symptom relief, reduce acute exacerbations and hospitalizations, but are associated with side effects. Therefore complementary method of treatment with potentially fewer side effects and relatively well-tolerated provide promising alternative. One such compound is quercetin, which is plant polyphenol and is present in variety of foods that we consume. Quercetin has potent antioxidant and anti-inflammatory properties and reduces oxidative stress and inflammation in a preclinical model of COPD. Quercetin exerts it antioxidant properties not only by neutralizing free radical species, but also by enhancing the expression of antioxidant enzymes. Similarly, quercetin inhibits various protein and lipid kinases by competing for adenosine triphosphate (ATP) binding sites thus reducing the inflammatory pathways.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with COPD, 40 - 80 yrs of age
* Post-bronchodilator forced expiratory volume (FEV)1/forced vital capacity (FVC) ratio 0.7, FEV1% predicted between 40 to 70
* Both active and ex-smokers with at least 10 pack-years history of smoking
* COPD patients taking H2 antagonists, loperamide or loratadine and willing to stop during the study period

Exclusion Criteria:

* Known allergy/sensitivity to quercetin
* Subjects with primary current diagnosis of asthma
* Upper respiratory tract infection within two weeks of the screening visit
* Acute bacterial infection requiring antibiotics within two weeks of screening
* Emergency treatment or hospitalization within one month of screening for any reasons
* Unwillingness to stop flavonoid supplementation
* Dietary intake exceeding or averaging 150 mg quercetin daily as assessed by Bioflavonoid Food and Supplement Screener
* Daily warfarin or cyclosporine (Neoral, Sandimmune)
* Subjects taking H2 antagonists (cimetidine, ranitidine), loperamide (Imodium) or loratadine and not willing to stop during study period
* Lung cancer history or undergoing chemo- or radiation therapy
* Inflammatory bowel disease
* Women of child-bearing age and unwilling to take pregnancy test
* Child-bearing age, who are unwilling to use adequate contraception or abstain during the course of the study.
* Pregnant or lactating mothers
Analysis of Functional Performance in Subjects With Obesity During Motor Tasks.

Background. Individuals with obesity can present several functional limitations that can significantly impact on their quality of life. Furthermore, even during the execution of specific motor tasks, subjects with obesity can experience excessive biomechanical overload. It is therefore necessary to develop appropriate assessment protocols that are able to provide support for risk assessment, in consideration of different types of motor tasks, including movements that can reflect the main daily and / or work activities. In this perspective, it is essential to define a protocol that includes an integrated evaluation process based on objective and quantitative metrics, i.e., functional scales, clinical scores, etc. In this context, the quantitative analysis of movement is widely used in clinical practice and in research to investigate in an objective and comprehensive way on movement disorders in various pathological conditions, including obesity. Conventionally, kinematic and kinetic parameters of movement are measured in motion analysis laboratories, using optoelectronic systems based on passive markers, force platforms and electromyographic systems, which represent the gold standard. Although motion analysis is considered accurate, the availability of specific laboratories, high costs and dependence on trained users sometimes limit its use in clinical practice. A variety of wearable sensors available today has enabled researchers and clinicians to pursue applications where individuals are monitored in home and outpatient settings.

Hypothesis and significance. The hypothesis is that wearables could reveal a good agreement, accuracy, and correlation between the parameters measured by means of optoelectronic system and those measured by wearables in individuals with obesity.

Specific Aims. The main objective is the implementation of an integrated protocol for the clinical evaluation of subjects with obesity through the analysis of the execution of different motor tasks typical of daily life and work. Appropriately identified clinical scores and scales will also be supported by quantitative evaluations carried out with human movement analysis systems (optoelectronic systems based on markers and inertial measurement units).


Eligibility Criteria:
Inclusion Criteria:

* BMI \>= 30/35 Kg/m2;
* No impediments to physical activity;

Exclusion Criteria:

* Pathologies of the locomotor system,
* Neurological pathologies affecting movement;
* Internal pathologies contraindicating physical activity;
* Pregnant or breastfeeding women;
* Individuals with genetic obesity (Down's or Prader-Willi syndrome).
Comparative Efficacy and Safety of Benzoyl Peroxide Used in Combination With Clindamycin vs. Benzoyl Peroxide Used in Combination With Clindamycin and Doxycycline in the Treatment of Moderate Acne

To compare the efficacy and safety of Benzoyl peroxide used in combination with clindamycin vs. Benzoyl peroxide used in combination with clindamycin and doxycycline in the treatment of moderate acne

To compare the efficacy and safety of Benzoyl peroxide used in combination with clindamycin vs. Benzoyl peroxide used in combination with clindamycin and doxycycline once daily in the treatment of moderate acne

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects with acne vulgaris . Able to understand the requirements of the study and sign informed consent/HIPAA authorization forms.

Exclusion Criteria:

* Known hypersensitivity to any of the components of the study drugs or used of prohibited medications or any medical condition that contraindicate the subject's participation in the clinical study
Safety and Effectiveness Study of 532nm Laser Subthreshold Panretinal Photocoagulation for Severe NPDR

This randomized, parallel controlled, clinical-trial aims to evaluate the therapeutic efficacy of 532nm laser partially subthreshold panretinal photocoagulation with PASCAL endpoint management function for severe non-proliferative diabetic retinopathy.

This randomized, parallel controlled, clinical-trial aims to evaluate the therapeutic efficacy of 532nm laser partially subthreshold panretinal photocoagulation with PASCAL endpoint management function for severe non-proliferative diabetic retinopathy : (1)To evaluate therapeutic effect of 532nm laser partially subthreshold panretinal photocoagulation with PASCAL endpoint management function for severe non-proliferative diabetic retinopathy; (2)To compare side effect of 532nm laser partially subthreshold panretinal photocoagulation with PASCAL endpoint management function on retina with traditional visible endpoint panretinal photocoagulation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of severe non-proliferative diabetic retinopathy
* Age:45-80 years
* Best corrected visual acuity(BCVA) ≥20/100,Myopia≤-6 degree(-6D)
* No photocoagulation (PRP) before this clinical trial and no major ocular surgery (including cataract extraction, or any other intraocular surgery) within 3 months
* Ability and willingness to provide informed consent

Exclusion Criteria:

* Participate in other clinical trials within 3 months
* Severe refractive media turbidity; Unable to accept laser treatment such as nystagmus, etc
* Medically or mentally unstable(including cardiovascular disorders, cerebrovascular diseases,liver and kidney disease,hematological disorder and psychosis
* Conditions that in the opinion of the investigator would interfere trial results or increase risk
* Conditions that in the opinion of the investigator would preclude participation in the study
HRQOL of Life After ECMO Due to COVID-19.

We intend to prospectively investigate physical and mental state (HRQOL) by means of quantitative telephone interviews after hospital discharge in patients surviving COVID-19 ARDS and ECMO therapy.


Eligibility Criteria:
Inclusion Criteria:

* patients surviving COVID-19 ARDS and ECMO therapy

Exclusion Criteria:

* no consent
Study of Blood Levels of Ceftaroline Fosamil in Children Who Are Receiving Antibiotic Therapy in the Hospital

The purpose of this study is to assess blood levels of Ceftaroline fosamil in children.

To characterize single dose pharmacokinetics of Ceftaroline fosamil in children.

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet the following inclusion criteria:

* Male or female children with ages from birth to younger than 12 years
* Hospitalized and receiving systemic antibiotic therapy for treatment of a suspected or confirmed infection
* Sufficient intravascular access
* Negative urine pregnancy test
* Written informed consent from parent(s)and verbal informed assent from subject

Exclusion Criteria:

Subjects must NOT meet any of the following exclusion criteria:

* History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial
* Past or current history of epilepsy or seizure disorder
* Moderate or severe renal impairment
* If female, currently pregnant or nursing
* Aspartate aminotransferase, alanine aminotransferase, or total bilirubin level \> 3 times upper limit of normal
* Any condition that would make the subject, in the opinion of the Investigator, unsuitable for the study
* Use of probenecid within 3 days prior to dosing
* Receipt of a blood transfusion during the 24-hour period before enrollment
Comparison of Thermo-plastic Versus Carbon Foot Ankle Orthosis to Improve Gait and Reduce Fatigue in Post-stroke Patients: a Biomechanical and Neurophysiological Study

Approximately 20% of stroke survivors have difficulties to dorsiflex the ankle and clear the ground during walking. This impairment, termed as "foot drop", is caused by an association of weak dorsiflexors and increased spasticity and stiffness of the plantar-flexors. As a consequence, walking performances are reduced and energy cost of walking is deteriorated. This may increase performance fatigability, as the locomotion will be realized at a higher percentage of the subjects' capacities. In order to overcome these issues, different treatments are proposed. One of the most conventional solutions are the use of ankle foot orthosis (AFO) and it is the most commonly prescribed device used to compensate for "foot drop". There is a very large choice of AFO on the market which can be proposed to patients with foot drop.

The aim of this study is thus to assess the mechanical effects of using a manufactured carbon AFO in by comparison to a custom-made thermo-plastic AFO on walking capacity (distance and energy cost), fatigue and "foot drop" control throughout the gait phase in patients with hemiparetic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Hemiparetic patients, walking with CM-AFO
* Diagnosis of a first stroke since at least 6 months with medical conditions of stroke known, treatment proposed, cardio-vascular and neurological state stabilized
* Foot drop observed during the swing phase of gait, requiring the use of a custom-made plastic orthosis that has been used for at least 3 months and used for less than 2 years
* Muscle spasticity not higher than grade 3 according to the Modified Ashworth Scale
* Sufficient motor ability and endurance to ambulate at least 15 m independently without AFO
* Patient who signed a consent
* Patients affiliated or entitled to a social security system.

Exclusion Criteria:

* Patients who did not have brain MRI imaging after their stroke to confirm the diagnosis of stroke,
* Patients with an associated cerebellar syndrome,
* Patients with clinical brainstem involvement (cranial pair deficit),
* Patients with a neurological history other than stroke that has an impact on walking,
* Patients with unstable cardiovascular or respiratory disorders likely to induce gait disorders that may influence the performance of the tests to a greater extent than in the case of vascular hemiplegics,
* Patients with alcohol or drug dependence,
* Patients with psychiatric illness, cognitive impairment, uncontrolled disease/epilepsy, malignant pathology, renal impairment, unstable or decompensated diabetes, severe,
* Patients with a history of associated disabling systemic disease,
* Patients who refused to sign the written consent,
* Patients with a current pregnancy,
* Patients under court protection.
Incidence of Adverse Airway Events in High Risk Patients Undergoing Upper GI Endoscopy Under Anesthesia

We propose to collect the data of vital signs and anesthesia medications administered in a subcategory of patients coming for anesthesia for upper GI endoscopy. This data will be analyzed to see any relation between the preoperative risk factors, procedure, type of anesthesia and the airway intervention. The adverse events that will be automatically recorded and later analyzed will be number of apnea episodes (described as no respiration for at least 30 seconds) duration of each apnea, number and duration of each desaturation event (oxygen saturation as measured by the pulse oximeter). A pulse oximeter saturation of less than 93 percent and lasting 30 seconds will be considered as a desaturation event. The airway interventions that will be recorded will be anything other than considered being routine. This includes LMA insertion, endotracheal intubation and the need to withdraw gastroscope to facilitate face mask ventilation. We also propose to monitor their awareness/depth of sedation/depth of anesthesia levels. This will be done using a monitor that analyses brain waves and gives an idea of sleep (anesthesia) depth. We can then see any correlation between any unwanted events and the sleep depth.


Eligibility Criteria:
Inclusion Criteria:

* All the patients considered as high risk (see above) or undergoing an advanced upper GI procedure (see above) will be included. This is the prospective analysis of the data that is collected and stored in the monitors. We will be using the massimo Pulse oximeter ,masimo acoustic respiratory monitor and Masimo SED line Brain function monitors that allows electronic storage and retrieval of information.
* Postprocedure analysis of the data will not influence the patient care.

Exclusion Criteria:

* Any patient who cannot give a valid consent will be excluded
* Children
* Pregnant women
* Fetuses and/or Neonates
* Prisoners