cyrilzakka/clinical-trials huggingface dataset:
NAVA vs. CMV Crossover in Severe BPD

This prospective, unblinded, pilot randomized cross-over trial of 2 modes of mechanical ventilation will compare measures of pulmonary mechanics, respiratory gas exchange, and patient comfort between conventional flow triggered mechanical ventilation and neurally adjusted ventilatory assist (NAVA) among 20 prematurely born infants and young children receiving invasive respiratory support for severe bronchopulmonary dysplasia (BPD).

Most research to date in neonatal lung disease has focused on bronchopulmonary dysplasia (BPD) prevention. As a result, insufficient investigation has been performed to define optimal respiratory management strategies for infants and young children with established BPD. Thus, there is no robust evidence base to guide ventilator management to promote lung disease recovery and support neurodevelopment in this population. Neurally adjusted ventilatory assist (NAVA) is an alternative to conventional flow triggered ventilation that has shown promise for improving respiratory gas exchange, patient-ventilator interaction, and work of breathing in preterm neonates. The safety and efficacy of NAVA in infants and young children with established, severe BPD is uncertain. This prospective, unblinded, pilot randomized cross-over trial of 2 modes of mechanical ventilation will compare measures of pulmonary mechanics, respiratory gas exchange, and patient comfort between conventional flow triggered mechanical ventilation and NAVA among 20 prematurely born infants and young children receiving invasive respiratory support for severe BPD.

Eligibility Criteria:
Inclusion Criteria:

1. Gestational ages (GA) ≤ 32 weeks
2. Current age between 36 weeks postmenstrual age (PMA) and 2 years corrected age
3. Severe BPD \[as per National Institutes of Health (NIH) consensus definition\] diagnosed at 36 weeks postmenstrual age
4. Receiving invasive mechanical ventilation for ongoing lung disease
5. Not expected to be ready for extubation within 11 days following enrollment
6. Parental consent

Exclusion Criteria:

1. Severe congenital anomalies
2. Known diaphragmatic defect
3. Current treatment with high frequency mechanical ventilation
4. Do not resuscitate (DNR) Status or Futility of Care
5. \>10% leak around the artificial airway,
6. Treatment with neuromuscular blockade within 72 hours prior to enrollment
7. Acute respiratory instability defined as a ventilator rate increase \> 15 beats per minute (bpm), Positive end-expiratory pressure (PEEP) increase \> 2 cm/water (H2O), sustained FiO2 increase \> 20%, and/or prescribed increase in tidal volume \> 2 mL/kg within 24 hours prior to enrollment will be excluded.
A Psoriasis Plaque Test Trial With LP0113 Spray in Patients With Psoriasis Vulgaris (LP0113-1123)

The purpose of this study is to evaluate the anti-psoriatic effect of LP0113 aerosol spray compared to Daivobet® gel, LEO 90100 aerosol foam, betamethasone dipropionate in the aerosol spray vehicle, calcipotriol in the aerosol spray vehicle and aerosol spray vehicle.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent has been obtained
* Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk. The lesions must have a total size suitable for application of 6 different products.
* Age 18 years or above
* Outpatients
* Female subjects must be of either

  * non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus or has tubal ligation) or,
  * child-bearing potential provided there is a confirmed negative pregnancy test prior to trial treatment to rule out pregnancy.

Exclusion Criteria:

* Female subjects who are breast feeding
* Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:

  * Etanercept - within 4 weeks prior to randomisation and during the trial
  * Adalimumab, infliximab - within 8 weeks prior to randomisation and during the trial
  * Ustekinumab - within 16 weeks prior to randomisation and during the trial
  * Other products - within 4 weeks/5 half-lives prior to randomisation and during the trial (whichever is longer)
* Systemic treatment with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4-week period prior to randomisation and during the trial,
* Subjects using phototherapy within the following time periods prior to randomisation and during the trial:

  * PUVA: 4 weeks
  * UVB: 2 weeks
* Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the trial:

  * Potent or very potent (WHO group III-IV) corticosteroids
* Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation and during the trial:

  * WHO group I-II corticosteroids (except if used for treatment of scalp and/or facial psoriasis)
  * Topical retinoids, Vitamin D analogues, Topical immunomodulators (e.g. calcineurin inhibitors), Tar products, Salicylic acid
* Subjects using emollients on the selected plaques within 1 week before randomisation and during the trial
* Initiation of, or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, antimalarial drugs, lithium and ACE inhibitors) within 2 weeks prior to the randomisation and during the trial
* Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
Weight Management for the Remission of Type 2 Diabetes Using a Proprietary Meal Replacement System- Diabetes Remission Study (DRS)

A three month meal replacement dietary system which combines meal replacements and self-prepared meals which hypothetically will result in Diabetes remission in \>30% of intervention subjects

To assess the efficacy of which patients with Type 2 Diabetes (non insulin dependent) can be brought into a optimal A1C remission state without the use of medications by achieving clinically significant weight loss (\>20-30 pounds) using a proprietary meal replacement system associated with a 3-month intensive lifestyle program.


Eligibility Criteria:
Inclusion Criteria:

* Men and Women
* Ages 25-65
* Have been diagnosed with non-insulin dependent diabetes for less than five years
* Are taking at least one oral agents for diabetes
* English speaking

Exclusion Criteria:

* Individuals currently being treated for cancer
* Had a myocardial infarction in the previous 3 months
* Have uncontrolled persistent hypertension - diastolic \>90 systolic \>160
* Individuals with established eating disorder diagnoses
* Individuals who have recent weight loss attempt in the last 3 months with \> 5-pound loss
* Use of anti-obesity medications in the last three months
* Individuals who have had bariatric surgery
* Individuals taking medications that are known to cause weight gain including but not limited to insulin, steroids, haloperidol clozapine, risperidone, olanzapine, amitriptyline imipramine, paroxetine, and lithium
* Individuals who are pregnant or planning to become pregnant in the next 6 months
Clinical Benefits of the Closed Loop Stimulation in Sinus Node Disease

The study is designed as a multi-center, international, prospective, parallel, randomized, single blinded trial comparing the time to first primary endpoint event (Sustained Paroxysmal AF/Persistent AF or stroke/TIA) occurrence in a follow up period of 3 years, between Closed Loop Stimulation (CLS) ON versus OFF, on top of a DDD pacing in patients with pacemaker or ICD indication who require dual-chamber pacing due to sinus node disease (SND), with or without atrioventricular (AV) block.

The benefits of rate-responsiveness on top of dual-chamber pacing still need to be definitively assessed in Sinus Node Dysfunction (SND). Although many rate responsive (RR) sensors have been developed, no large clinical trials evaluated their benefits in terms of clinical endpoints such as clinically relevant atrial fibrillation (AF) and stroke. Electromechanical sensors (piezoelectric accelerometers) have been widely used for their simplicity and overall reliability. However there is some evidence indicating the Closed Loop Stimulation as one of the more efficient and physiological sensors.

Two randomized clinical studies have been conducted so far, showing that in the Brady-Tachy Syndrome the CLS algorithm was associated with a significantly lower overall atrial arrhythmia burden as compared both with a DDDR mode based on a standard accelerometric sensor and an atrial overdrive approach.

Both studies yielded consistent results, albeit with a parallel and intraindividual comparison designs, respectively. The atrial arrhythmic burden is an important but surrogate endpoint, not necessarily related to long-term clinical outcome. The CLS effects on AF (if any) should be investigated in terms of time to first new onset of clinically relevant AF.

In the light of these considerations, it appears interesting to run a large randomized study coherently collecting data on the overall clinical benefit of CLS, primarily in terms of AF and stroke, in a population indicated for pacemaker or ICD and needing dual-chamber pacing due to SND.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Class I or II recommendations for permanent pacing due to SND, with or without AV block according to the current guidelines;
* Patients for whom dual-chamber pacing is indicated or preferred;
* Patients with an optimized and stable antiarrhythmic medical therapy at the time of enrolment;
* Closed Loop Stimulation function was not previously activated;
* No stroke events from implant;
* Patient implanted for the first time;

Exclusion Criteria:

* Permanent AF (PermAF)
* NYHA Class IV Heart Failure
* Stage V kidney dysfunction
* Any indication to Cardiac Resynchronization Therapy (CRT)
* Life expectancy \< 1
* Minors
* Pregnant or breast-feeding patients
* Participation in another interventional trial
* Atrial fibrillation ablation (left pulmonary veins) or other cardiac surgery \< 3 m
Impact of Alcohol Labels in a Real-World Setting

The goal of this randomized controlled trial is to evaluate the impact of health information labeling on alcohol-related knowledge and behaviors in adults purchasing alcohol in Barcelona, Spain. The main questions it aims to answer are:

* Does a label containing a cancer message have a larger impact on knowledge, behavior, intentions, risk perception, emotional response, product appeal and policy support compared to a responsibility label?
* Does the positioning of the label (front vs. back) on the alcohol container affect these outcomes?

Researchers will compare the impact of cancer message labels vs. responsibility labels and front vs. back positioning to see if there are differences in the primary outcome (knowledge of alcohol causing cancer) and secondary outcomes (behavior, intentions, risk perception, emotional response, and policy support).

Additionally, the study will provide insight in whether there is a testing effect of primary outcome pre-measurement by exposing only half of the sample to baseline question on knowledge of alcohol related harms.

Participants will:

* Be recruited in front of selected supermarkets in Barcelona after purchasing alcohol for their own consumption.
* Complete a baseline questionnaire.
* Receive a sticker containing a randomly assigned health message that will be applied to every alcohol beverage they have purchased.
* Receive an invitation to complete two follow-up surveys, one a week and one a month after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* have just purchased at least one alcoholic beverage container for their own consumption
* speak Spanish or Catalan
* are 18 years or older
* provide informed consent to participation

Exclusion Criteria:

- all the purchased alcohol containers are too small for a label sticker to be affixed
Cameroon Mobile Phone SMS Trial

The investigators hypothesize that sending weekly motivational text messages to people infected with HIV will encourage them to take their medication, compared to usual care.


Eligibility Criteria:
Inclusion Criteria:

* On HAART for at least 1 month
* 21 years or more
* Owns a mobile phone
* Can read text messages

Exclusion Criteria:

* On HAART for less than 1 month
* Aged less than 21 years
Study of Pirtobrutinib (LOXO-305) in Participants With Impaired Kidney Function and Healthy Participants

The main purpose of this study is to measure how much of pirtobrutinib (LOXO-305) gets into the bloodstream and how long it takes the body to eliminate it in participants with impaired kidney function and healthy participants. The side effects and tolerability of pirtobrutinib will also be evaluated. Participation could last around 46 days.


Eligibility Criteria:
Inclusion Criteria:

* Participants with impaired renal function \[estimated Glomerular Filtration Rate (eGFR): \< 90 milliliters per minute (mL/min) per 1.73 square meters (m2)\] and healthy participants with normal renal function \[(eGFR: ≥ 90 mL/min/1.73 m2)\].
* Males and females of non-childbearing potential.
* Within body mass index (BMI) range 18.5 to 40.0 kilograms per square meter (kg/m²).
* Participants will be in good health, based on medical history, physical examination findings, vital signs, 12 lead electrocardiogram (ECG), or clinical laboratory tests, as determined by the Investigator (or designee).
* Able to comply with all study procedures, including the 8-night stay at the Clinical Research Unit and follow-up phone call.

Exclusion Criteria:

* History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:

  1. liver disease
  2. pancreatitis
  3. peptic ulcer disease
  4. intestinal malabsorption
  5. gastric reduction surgery
  6. history or presence of clinically significant cardiovascular disease.
* Participants with out-of-range, at-rest vital signs.
* Abnormal laboratory values determined to be clinically significant by the Investigator (or designee).
* Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination.
* Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to the first dose administration (Day 1).
* Use or intention to use any prescription or over-the-counter medications within 14 days prior to the first dose administration (Day 1) and through end of trial.
* History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.
* Donation of blood from 56 days prior to Screening, plasma or platelets from 4 weeks prior to Screening.
* Receipt of blood products within 2 months prior to Check-in (Day -1).
* Significant history of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
SARS-CoV-2, TESTOSTERONE AND MALE FRAGILITY

The hormonal environment (steroid, primarily) could have a very relevant pathophysiological role in association with SARS-CoV-2. That is, testosterone could play a relevant role in leaving male subjects more exposed to infection and more prone to developing severe complications following COVID-19 infection.

Preliminary data suggests that male individuals are more susceptible to COVID-19 infection, at least in Western countries, and that their mortality rate is higher than female individuals. This would seem to suggest that the hormonal environment (steroid, primarily) could have a very relevant pathophysiological role in association with SARS-CoV-2. That is, testosterone could play a relevant role in leaving male subjects more exposed to infection and more prone to developing severe complications following COVID-19 infection. Another option is that COVID-19 infection could cause a condition of acute hypogonadism, following which, the exhaustion of androgenic action could act as a co-trigger of a severe or even fatal course of the disease.

Eligibility Criteria:
Inclusion Criteria:

Patient Cohort:

* Male patients with an age \> 18 hospitalized in the departments dedicated to the care of patients affected by COVID-19 at the San Raffaele Hospital and with:
* biological samples positive for SARS-CoV-2;
* negative test but highly suggestive clinical and radiological picture;
* patients discharged from the emergency room with biological samples positive for SARS-CoV-2;
* ability to read and sign the informed consent

Control Cohort:

* healthy donors with an age\> 18 accessing the IRCCS OSR Blood Donor Center;
* ability to read and sign the informed consent

Exclusion Criteria:

* People with an age \< 18;
* incapacity to read and sign the informed consent
SWE in Assessment of CKD Patients

Elastography is a developing technique to assess tissue elasticity. It is software that can be integrated to the ultrasonography machines. Shear wave Elastography (SWE) is an Elastography technique that does not require external pressure on the tissue and supplies quantitative data. It uses real-time short-duration acoustic push pulse to generate shear waves that propagate perpendicular to the main ultrasound beam. When the waves hit the targeted tissue, the tissue is "pushed" in the direction of propagation, causing it to temporarily deform or displace. The ultrasound scanner can monitor the tissue displacement, measuring the time-to-peak displacement and the recovery time. Shear wave velocity increases in diseased tissues, which can be significantly stiffer than normal ones. The parameters are expressed in pressure units of kilopascals (kPa) and velocity (m s-1). SWE have been used to study breast, thyroid, prostate and liver diseases. However, the application of SWE in assessment of renal fibrosis in CKD patients is still unclear.


Eligibility Criteria:
Inclusion Criteria:

* The patients are those older than 18 years diagnosed with CKD based on the KDIGO (Kidney Disease Improving Global Outcomes) definition i.e. eGFR less than 60 mL/min and/or the presence of markers of kidney damage (pathological albuminuria of at least 30 mg per 24 hours or proteinuria, hematuria, casts) persisting for more than 3 months.

Exclusion Criteria:

* Patients whose BMI \>35kg/m 2 Any condition that precludes visualization of the kidney by ultrasound or transmission of shear waves as pregnancy or marked ascites patients with surgical kidney problems like hydro or pyonephrosis patients unwilling to complete the study. Patients with a history of renal replacement therapy (hemodialysis, peritoneal dialysis) , renal transplant, or acute kidney injury within the last 3 months Patients with cystic kidney disease Patients with renal masses
Coload Optimization Guided by Inferior Vena Cava Collapsibility Index

The purpose of this study is to investigate the optimal coload guided by inferior vena cava collapsibility index in parturients with prophylactic norepinephrine infusion undergoing cesarean section.

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Vasopressors has been highly recommended for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential substitute drug for phenylephrine, norepinephrine has gradually been used in parturients undergoing cesarean section. There's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. However, our study (NCT03997500) had been shown that inferior vena cava collapsibility index (IVC-CI) markedly decreased in prophylactic norepinephrine infusion versus normal saline after spinal anesthesia and fetal delivery, suggesting that more prudent fluid management is required. The ideal dose of coload and coload is still unknown. Thus, the purpose of this study is to investigate the optimal coload guided by IVC-CI in parturients with prophylactic norepinephrine infusion undergoing cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years
* Primipara or multipara
* Singleton pregnancy ≥37 weeks
* American Society of Anesthesiologists physical status classification I to II
* Scheduled for elective cesarean section under spinal anesthesia

Exclusion Criteria:

* Body height \< 150 cm
* Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
* Eclampsia or chronic hypertension or baseline blood pressure ≥ 160mmHg
* Hemoglobin \< 7g/dl
* Fetal distress, or known fetal developmental anomaly
BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence

This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in participants with overactive bladder and urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months
* Inadequate response or limiting side effects with pharmacotherapy for the treatment of OAB

Exclusion Criteria:

* Overactive Bladder caused by neurological condition
* Patient has predominance of stress incontinence
* History or evidence of pelvic or urological abnormality
* Prior use of BOTOX for any urological condition
Improving Management of Post-partum Haemorrhage With Quantra® System

Post partum haemorrhage is a concerning situation in maternity wards, though it is not the first cause of maternal mortality anymore.

It has been already shown that low fibrinogen level is a major predictive factor of massive bleeding after delivery.

In this situation, the early knowledge of fibrinogen level could enhance care of women experiencing post partum haemorrhage.

In a cohort of women suffering from post partum haemorrhage, this study will evaluate whether assessing fibrinogen level would be faster using the Quantra® system than the standard coagulation test.


Eligibility Criteria:
Inclusion Criteria:

Women ≥ 18 years old Experiencing post partum haemorrhage ≥ 500 mL Within 24 hours after delivery

Exclusion Criteria:

* Previous anemia ≤ 7g/dL
* Known bleeding disorders
* Ongoing antiplatelets treatment
* Ongoing anticoagulant treatment