cyrilzakka/clinical-trials huggingface dataset:
Viral Infections and Airway Microbiome in Young Children With Cystic Fibrosis

Cystic fibrosis (CF) is the most common hereditary life-threatening condition in Belgium. Because of a dysfunctional cystic fibrosis transmembrane conductance regulator (CFTR) channel, chloride is unable to move to the cell surface and mucus becomes more viscous. Consequently, CF patients are not able to clear their lungs efficiently, and trapped bacteria can lead to chronic infection and inflammation of the lungs, and ultimately respiratory failure.

CF lung disease starts at birth due to muco-inflammatory processes and is associated with a significantly altered microbial colonization of the infant airways compared to infants without CF. Additionally, young children with CF suffer from viral infections as often as their healthy peers, but the episodes are more severe and often prolonged. Moreover, frequent viral infections in children with CF contribute towards a more pathogenic airway microbiome at a young age. Although this link has been previously reported, the exact mechanisms by which this occurs need to be elucidated.

A pulmonary exacerbation in CF is characterized by an increase in respiratory symptoms, general symptoms and a decline in lung function. Most young children with CF suffer from a mean of 4 exacerbations per year for which antibiotics are prescribed. Despite the current novel therapies in CF, treatment of respiratory infections stay relevant and is a greater challenge with increasing survival.

The key objective of this study is to gain insights into the mechanisms by which viral infections leading to pulmonary exacerbations induce a more pathogenic microbiome in young children with CF.

About forty participants will be recruited at the paediatric CF clinic of the Antwerp University Hospital. Inclusion criteria are an age of less than 5 years and a diagnosis of CF. There are no exclusion criteria. Duration of the study is 1 year to cover for seasonality of clinical symptoms. Study visits are scheduled at 3-month intervals corresponding with the regular follow up, or unscheduled during an acute pulmonary exacerbation. From all participants, two oropharyngeal swabs (for microbiome analysis and for immunological/mucin analysis) will be collected at set time points. For the linking of the laboratory data to the clinical characteristics, we will examine demographics, environmental exposures, and disease markers of CF. Next to the collection of the oropharyngeal swabs, a history, physical examination, and technical investigations will be performed at the study visits.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cystic fibrosis

Exclusion Criteria:

* None
Registry of Etanercept Use in Patients With Rheumatoid Arthritis in Clinical Practice in Taiwan

The purpose of this study is to develop a registry with safety and efficacy data on the use of etanercept in clinical practice in Taiwan.


Eligibility Criteria:
Inclusion Criteria:

Main Inclusion Criteria: 1) Male or female patients aged \> 20 years; 2) Patients who have already been selected and approved under the Taiwan National Health Insurance Program to receive 24 weeks of etanercept for rheumatoid arthritis. Main

Exclusion Criteria:

Exclusion Criteria: None
Comfort Check of CO2 Monitoring Cannulas With Oxygen Delivery

The purpose of this test is to evaluate the comfort level of several model configurations of the Smart CapnoLine plus cannula The test focuses on the comfort / discomfort generated by the device, mainly due to tubes around the ears and on the face skin, the cannula itself (especially in the nostrils and the mouth surrounding) and the smell.

This test compares 4 models for the duration of up to 3 days each and 2 models with duration of up to 24 hours. Each subject will tested the models and will provide feedback at predefined times during the test. During the test and according to initial result the team may decide to shorten the test duration.

The testing staff will include a dermatologist and a technical representative that will supervise the test in order to monitor and control the required performance of the subjects according to test protocol, and relevant outcomes. During the test the dermatologist will monitor any unexpected skin reaction or patient discomfort.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers
* Men and Women
* Age 50-85
* Willingness to participate in the study

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Subjects with sensitivity to any of the products or the its ingredient
* Subjects with sensitivity to preparation for testing bacterial plaque
* Subjects who are treated with anti inflammatory antihistamine corticosteroids treatment
* Subjects who are treated with Anti-thrombotic agents
Validation of a Vital Signs Monitoring Wristband

Today, continuous monitoring of vital signs remains a challenge since it generally requires the patient to be connected to multiple wired sensors, which restricts patient mobility in the intra-mural setting and complicates home monitoring in the extra-mural setting. Wearable devices on the wrist, although emerging, are often not clinically validated or limited to the monitoring of one or two vital signs.

This study aims to validate the Corsano CardioWatch 287-2 for the continuous monitoring of heart rate at ≤ 4 bpm root mean squared error (RMSE); interbeat intervals at ≤ 50 ms RMSE; breathing rate at ≤ 2 brpm RMSE; and peripheral oxygen saturation at ≤ 3 percentage point RMSE. Also, this study aims to validate the Corsano CardioWatch 287-2 for the measurement of non-invasive blood pressure according to ISO 81060-2:2018.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old;
* undergoing invasive monitoring, like coronary angiography;
* able to provide consent.

Exclusion Criteria:

Patients

* who cannot wear the Corsano CardioWatch 287 due to reasons such as allergic reactions, wounds, amputations etc.;
* unable or not willing to sign informed consent;
* with significant mental or cognitive impairment;
* who do not have a suitable entry site for the invasive arterial line
* who do not comply to criteria established by ISO 81060-2:2018.
Physical Exercise Therapy vs Relaxation in Allogeneic Stem Cell Transplantation (PETRA)

The PETRA-Study is a randomized, controlled trial and designed to examine the effects of an one-year physical exercise intervention on prognosis, side-effects and complications after allogeneic stem cell transplantation.

The exercise intervention includes both, resistance and endurance training. Patients assigned to the control group perform a relaxation program (progressive muscle relaxation - Jacobsen) and have the same frequency of social contact.


Eligibility Criteria:
Inclusion Criteria:

* Medical indication: allogeneic stem cell transplantation

Exclusion Criteria:

* Orthopeadic limitations that hamper the exercise intervention
* Osseous degenerations that have an improved fracture risk
A Safety Study of SGN-CD19A for B-Cell Lymphoma

This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of SGN-CD19A in patients with relapsed or refractory B-lineage non-Hodgkin lymphoma (B-NHL)


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma Grade 3, diffuse large B-cell lymphoma (DLBCL), including transformed follicular histology, Burkitt lymphoma, or B-lineage lymphoblastic lymphoma
* Relapsed, refractory, or progressive disease following at least 1 prior systemic therapy. Patients with DLBCL or follicular lymphoma Grade 3 must have also received intensive salvage therapy.
* Eastern Cooperative Oncology Group status of 0 or 1
* Measurable disease

Exclusion Criteria:

* Allogeneic stem cell transplant (SCT)
Evaluation of Bioavailability of Phenolic Compounds From Oxxynea®

The aim of this study is to evaluate bioavailability and pharmacokinetics of phenolic compounds from Oxxynea®, a blend of fruit and vegetable extracts, in healthy volunteers, during a randomized, double-blind and cross-over trial. After a single dose supplementation, both metabolic profile and urinary excretion will be determined over a 48h-period by means of High-Performance Liquid Chromatography coupled with a tandem mass spectrometry (HPLC-MS) to identify and quantify phenolic metabolites. In parallel, post-prandial potential anti-oxidative and anti-glycemic properties of Oxxynea® will be determined in blood, following consumption of a cafeteria-type breakfast.


Eligibility Criteria:
Inclusion Criteria:

* In good general health
* Agreement to adhere to diet considerations

Exclusion Criteria:

* Smoking
* Pregnancy / Lactation
* Current use of any medication or food supplement
* Known allergic reaction to components of the supplement/placebo
Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery

Hypothesis: Treatment with levosimendan will preserve myocardial function and hemodynamics after cardiac surgery and lead to reduced stay at intensive care unit

Single center, prospective, randomized parallel-group, double-blinded study

Eligibility Criteria:
Inclusion Criteria:

* EF (ejection fraction)\<40%

Exclusion Criteria:

* renal failure, liver failure
Cardiovascular Vulnerability to Particulate Exposure

This project is part of a program project directed toward assessing cardiac effects of particulate and other ambient air pollutants. In this project active elderly adults living in the communities of Boston and Steubenville have attended 12 weekly sessions including approximately 40 minutes of Holter monitoring, blood pressure, and oximetry evaluation before, during, and after outdoor exercise. To investigate the relation of air pollution to cardiac and pulmonary rehabilitation, a second portion of this study involves abstraction of blood pressure and symptom data and downloading of available repeated measures telemetry data in two populations. These populations include: 1) 200 outpatients attending 8 to 36 repeated weekly exercise training sessions in a major hospital cardiac rehabilitation unit.

Approximately 60 subjects have participated fully in Boston and Steubenville in the repeated 40 minute measurement of continuous EKG (Holter), blood pressure, and oximetry. In Steubenville we have also measured exhaled nitrogen oxide, an index of pulmonary inflammation. The exposure monitoring has included outdoor particle mass of PM2.5, outdoor gaseous pollutants, and indoor home and personal monitoring to evaluate the indoor contribution of pollution to health effects.

Eligibility Criteria:
Participants are 50 to 90 years of age, but almost all are 60 and older. They have been enrolled as volunteers from communities in Mission Park, Boston, and Steubenville. Inclusion criteria includes the ability to walk on level ground. Exclusion criteria includes unstable anginal, and baseline EKG patterns such as left bundle branch block that would make difficult the detection of repolarization abnormalities. Participants live at or near the study center which was located in an office or apartment in the apartment building of the majority of the participants.
Lumbar Puncture Stylet Technique in Children

Lumbar puncture (LP) is a procedure performed frequently among children in the emergency department (ED). Although it has been performed for decades, and for distinct indications, the technique itself can often lead to traumatic results, which can complicate its interpretation and lead to over-treatments and hospitalizations. Several factors have been suggested to improve the success rate of LPs. Among them, the stylet-out (SO), also known as the early stylet removal technique, has been suggested but not properly studied.

The aim of this study is to evaluate whether the stylet-out technique can reduce the probability of failure or traumatic lumbar puncture procedures in a pediatric population presenting to the emergency department as compared to the standard stylet-in (SI) approach.

To achieve this goal, the investigator will conduct a randomized controlled trial comparing the SO versus SI techniques in a tertiary care, pediatric, university-affiliated emergency. All children younger than 18 years of age requiring a LP as part of their ED workup will be eligible and randomized to either the standard SI or SO group. The primary outcome will be the first-attempt LP success rate as defined by the minimum amount of cerebrospinal fluid (CSF) necessary to perform a leukocyte count and bacterial/viral CSF cultures, according to each laboratory with red blood cell count \< 1000/mm3. Secondary outcomes will include the following: overall LP success rate (i.e. despite number of attempts), proportion of traumatic LP, number of LP attempts, number of changes in providers performing the LP, proportion of traumatic LP, total time to procedure, mean difference in pain scores and satisfaction rates in both groups.

The hypothesis is that the use of the Stylet Out approach will reduce the number of failed and traumatic LP in the pediatric population presenting to the ED as compared to the standard SI approach.


Eligibility Criteria:
Inclusion Criteria:

* All patients younger than 18 years of age (no minimal age)
* All patients who require a diagnostic lumbar puncture as part of their emergency department workup

Exclusion Criteria:

* Patients with lumbar puncture contraindications
* Parents/patients unable to give consent
* Patients who have had a traumatic of failed lumbar puncture prior to the emergency department transfer
RECOVER-SLEEP: Platform Protocol, Appendix_B (CPSD)

The platform protocol is designed to be flexible so that it is suitable for a range of study settings and intervention types. Therefore, the platform protocol provides a general protocol structure that can be shared by multiple interventions and allows comparative analysis across the interventions. For example, objectives, measures, and endpoints are generalized in the platform protocol, but intervention-specific features are detailed in separate appendices.

This platform protocol is a prospective, multi-center, multi-arm, randomized controlled platform trial evaluating potential interventions for PASC-mediated sleep disturbances. The hypothesis is that symptoms of sleep and circadian disorders that emerge in patients with PASC can be improved by phenotype-targeted interventions. Specific sleep and circadian disorders addressed in this protocol include sleep-related daytime impairment (referred to as hypersomnia) and complex PASC-related sleep disturbance (reflecting symptoms of insomnia and sleep-wake rhythm disturbance).

Interventions will be added to the platform protocol as appendices. Each appendix will leverage all elements of the platform protocol, with additional elements described in the individual appendix.

After completing Baseline assessments, participants will be randomized to an intervention group, which is based on their sleep phenotype, or into a placebo/control group.

Eligibility Criteria:
Inclusion Criteria:

• See NCT06404086 for RECOVER-SLEEP: Platform Protocol level inclusion criteria which applies to this appendix

Exclusion Criteria:

• See NCT06404086 for RECOVER-SLEEP: Platform Protocol level exclusion criteria which applies to this appendix

Additional Appendix B (CPSD) Level Inclusion Criteria:

The following additional exclusion criteria are to be considered together for determining eligibility. They are separated here by TL and melatonin only for presentation. RESET-PASC presents no additional exclusions.

TAILORED LIGHTING EXCLUSION CRITERIA

1. Severe visual impairments affecting sensitivity or ability to respond to light
2. Severe photosensitivity dermatitis
3. Severe progressive retinal disease, eg, macular degeneration
4. Permanently dilated pupil, eg, following certain cataract surgeries
5. Unwilling to remove or not wear blue-light-blocking glasses during TL dosing

MELATONIN EXCLUSION CRITERIA

1. Sleep medication, if not willing to washout for 4 weeks.
Comparison of Effectiveness Between the Combination of Lidocaine Sprayed at Laryngeal Inlet and on the Cuff of Endotracheal Tube Versus Intravenous Lidocaine for Reducing Cough During Extubation

Coughing during extubation of endotracheal tube (ETT) is a common problem that leads to poor surgical results including hemodynamic change, rebleeding at the surgical wound and wound dehiscence. Recently, lidocaine has been introduced for reducing coughing during extubation. However, data comparing routes of lidocaine application are lacking, thus, this study compared the combination of lidocaine sprayed on laryngeal inlet and cuff of ETT versus intravenous lidocaine injection for efficacy in reducing coughing

A prospective randomized control trial was conduct with 164 patients. They were randomly allocated into Gr. A and B. Group A received four puffs of 10% lidocaine sprayed at the cuff of ETT and four puffs at laryngeal inlet whereas Gr. B received 15 mg/kg of 2% lidocaine intravenous injection prior to extubation. The same general anesthesia protocol was applied in all of the patients. Incidence and severity of cough during extubation was evaluated. Furthermore, incidence of 24-hour postoperative adverse events (including sore throat, dysphagia, and hoarseness) and hemodynamic response after extubation were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent elective surgery with American Society of Anesthesiologists physical status classifications of I and III

Exclusion Criteria:

* patients having body mass index more than 35 kg/m2, high risk of aspiration, chronic smokers more than ten pack-years, chronic cough or recent upper respiratory infection, suspected difficult airway, retained ETT prior surgery, surgery at oral cavity, neck and thoracic region, operative time more than 120 minutes or less than 30 minutes, and history of lidocaine allergy
Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics

Evaluate the application of the new therapeutic model post Fast Track surgery, in complicated acute appendicitis, in pediatric population on the rate of complications postoperative in the form of abdominal abscesses.

Complicated appendicitis is defined as the finding in the intraoperative study of a perforated, gangrenous or contaminated appendix with the presence of periappendicular abscess. In November 2005, the synthesis of an "Evidence-based clinical practice guide for acute appendicitis in pediatrics" at the Hospital Vall d'Hebron, the result of a committee of experts in the field. This protocol has been the guideline for our center in recent years.

Currently, the therapeutic approach is based on monotherapy antibiotic management (except for drug allergies, appendicular peritonitis, immunosuppression or nosocomial acquisition) in the postoperative period, with a minimum duration of 5 days (intravenous treatment). Therefore, the minimum hospital stay in these patients is expected to be equal to or more than 5 days.

Acute appendicitis represents the most frequent cause of acute abdomen in pediatric patients older than two years. It affects approximately 80,000 children in the European Union, making appendectomy one of the most frequent non-elective pediatric interventions performed by pediatric surgeons.

In recent years, several ambispective studies have been carried out at national level applying new therapeutic models that allow shortening the hospital stay by applying more lax discharge criteria and reducing the duration of intravenous antibiotic treatment, without significant alterations in the rate of postoperative complications.

By reducing hospital stay, the fast-track model not only brings clinical benefits to patients, but also economic benefits to the healthcare system.

Eligibility Criteria:
Inclusion criteria:

* Ages 2 to 16 years Intraoperative diagnosis of complicated appendicitis. Laparoscopic appendectomy. 72 hours postoperative. Leukocyte count and C-reactive protein at 72 hours post-surgery increased (minimum 20% with respect to the preoperative baseline). Complete oral tolerance. Pain controlled with conventional analgesia.Afebrile (more than 24 hours).

Exclusion criteria:

* History of cystic fibrosis, Crohn's disease, transplant or appendicitis. Chronic requiring elective technique. Contraindication to the administration of amoxicillin-clavulanic acid. Refusal to participate in the study by parents/legal guardians.
Carvedilol Post-intervention Long-term Administration in Large-scale Trial

The purpose of this study is to evaluate whether beta-blocker therapy improves 6-year clinical outcomes in patients with ST-segment elevation acute myocardial infarction and preserved left ventricular ejection fraction after primary percutaneous coronary intervention.

Beta-blocker therapy is recommended after ST-segment elevation acute myocardial infarction (STEMI) in the current guidelines although its efficacy in those patients who have undergone primary percutaneous coronary intervention (PCI) has not been adequately evaluated. The purpose of this study is to evaluate whether beta-blocker, carvedilol improves 6-year clinical outcomes in patients with STEMI and preserved left ventricular ejection fraction after primary PCI. The design of this study is multicenter, open-label, randomized controlled trial enrolling 1300 patients without any exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Patients with STEMI after primary PCI
* Patients with left ventricular ejection fraction more than or equal to 40%

Exclusion Criteria:

* Patients with left ventricular ejection fraction less than 40%
* Patients with contraindication for beta-blocker
* Patients with implantable cardioverter defibrillators
* Patients with end-stage malignancy
Minimally Invasive Hypoglossal Nerve Stimulation Study (Lingual Study)

The purpose of this study is to assess the effect of Transvenous Hypoglossal Nerve Stimulation (tHGNS) on tongue position in the upper airway. Activation of the HGN will cause contraction of the genioglossus muscle, which will move the tongue forward, opening the upper-airway and reducing apnea-hypopnea events in patients with Obstructive Sleep Apnea (OSA). A transvenous approach will be less risky and traumatic than current HGNS systems that require an open surgical approach to wrap a cuff electrode around the HGN.

The primary objective is to determine the effect of tHGNS on tongue position in the upper airway in subjects undergoing an EP, cardiac catheterization or device procedure. (Measured as changes in the anteroposterior dimensions (2-dimensional) of the retropalatal and retrolingual airway spaces.) This will be an acute study lasting no more than 45 min during a standard new device implant, cardiac catheterization and/or EP procedure. The hypoglossal nerve will be stimulated from the lingual vein using various stimulation parameters. Tongue motion, upper airway opening or any side effects will be recorded. At the end of the test procedure all hardware - the catheters, lead and/or guide wire will be removed.

Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years old
* Subject is undergoing a standard new device implant, cardiac catheterization involving right heart catheterization and/or EP procedures
* Subject is able and willing to give informed consent

Exclusion Criteria:

* Subject is unable or unwilling to participate with study procedures
* Subject is pregnant (all women with childbearing potential must have a negative pregnancy test within 7 days prior to enrollment)
* Subject is known to be allergic to radio opaque dye
* Subject has a body mass index (BMI) \>40 kg/m2
* Subject has had prior neck surgery that may interfere with vascular access to the lingual vein
* Subject has had prior surgery of the oral cavity that may interfere with tongue or soft palate movement
* Subject has a significant upper airway-related anatomic anomaly
* Subject is enrolled in a concurrent study that may confound the results of this study.