cyrilzakka/clinical-trials huggingface dataset:
Humidity Strategy to Decrease Morbidity and Mortality in Extremely Low Birth Weight Infants

The purpose of this study is to apply a different incubator humidity strategy at birth to decrease morbidity and mortality in extremely low birth (1000 g or less) infants.


Eligibility Criteria:
Inclusion Criteria:

* Inborn Premature Infants with weight ≤ 1000 g at birth

Exclusion Criteria:

* Outborn infants.
* Failure to obtain parental consent for the study.
* Congenital malformations likely to affect life expectancy or neurosensory development.
* Unlikely to be available for follow up.
Two Stepped Care Models for Posttraumatic Stress Disorder (PTSD) Among Cambodian Refugees With PTSD

This project aims to investigate the efficacy of two models to treat Posttraumatic Stress Disorder (PTSD) for Cambodian refugees in primary care. The first step in both models is giving a medication, which is a serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SSRN), with paroxetine being the first-line agent. For those patients who still have PTSD, the second step is either another medication or a culturally sensitive cognitive behavioral therapy (CBT). The investigators hypothesize that patients will improve in both models, but more so in the the CBT model.

This project aims to investigate the efficacy of two models to treat PTSD for Cambodian refugees in primary care. The first step in both models is giving a medication (an SSRI/SSRN, e.g., paroxetine). For those who still have PTSD, the second step is either adding another medication (e.g., prazosin) or providing culturally sensitive cognitive behavioral therapy (CBT). We hypothesize that patients will improve in both models, but more so in the the CBT model. The primary outcome measure is PTSD severity as assessed by the PTSD Checklist (PCL). Eligibility requirements include having PTSD and having been old enough to remember the Khmer Rouge period.

Eligibility Criteria:
Inclusion Criteria:

* PTSD;
* PCL great or equal to 44;
* Survivor of the Cambodian genocide;
* At least 7 years old at the time of the Cambodian genocide

Exclusion Criteria:

* Pregnant;
* Active suicidality;
* Mental retardation;
* Organic mental disorder;
* Bipolar disorder;
* Alcohol dependence;
* Marijuana dependence;
* Unable to give conformed consent
Detection of Influenza A, Influenza B, and RSV Using the Liat™ Assays on the Liat™ Analyzer

The objective of this study is to evaluate the clinical sensitivity and specificity of the Liat™ Influenza A/B \& RSV Assay and the Liat™ Influenza A/B Assay when used on the Liat Analyzer to detect the presence or absence of Influenza A, Influenza B, and RSV in a nasopharyngeal swab specimen as compared to an FDA approved NAAT and culture.


Eligibility Criteria:
Inclusion Criteria:

* Patients exhibiting 2 or more symptom groups characteristic of influenza and/or RSV at the time of visit or within the past 48 hours:

  1. fever of at least 37.8 C (100F)
  2. runny or stuffy nose
  3. coughing, wheezing or difficulty breathing
  4. sore throat, headache, extreme tiredness, or muscle aches
  5. infants: decreased activity, irritability, poor feeding
* Subject who are able to understand and consent to participation; for minors under the age of 18, this includes a parent or legal guardian

Exclusion Criteria:

* Patients who are under-going anti-viral medication now or within the last 7 days.
* Patients who received Nasal Spray Flu Vaccine within the last 6 weeks
A Comparison of Videolaryngoscope and Direct Laryngoscope in IOP Changes, Throat Pain, IT and Hemodynamic Variables

The aim of the study was to compare intraocular pressure, intubation time, throat pain and hemodynamic variables using direct or videolaryngoscopy under general anesthesia requiring endotracheal intubation

INTRODUCTION Videolaryngoscopes are the new generation devices which were introduced into the difficult intubation algorithm by the American Society of Anaesthesiologists (ASA) in 2013 (1). Videolaryngoscopes are known to be superior to traditional direct laryngoscopy in cases of difficult airway, glottic visualisation is obtained more easily and less airway trauma is seen (2). Portable videolaryngoscope which is used in difficult airways (3). There are 2, 3, and 4 numbered blades. In the light source of the blade of the videolaryngoscope, there is a camera which is connected to a video screen monitor. In addition to passing soft tissues by visualisation, the camera is helpful in defining the glottic appearance (1).

There are studies which have compared the hemodynamic response and increase in IOP in intubation using direct laryngoscope and various videolaryngoscopes and airway devices . However, to the best of our knowledge there is no study comparing the effect on the increase in IOP of videolaryngoscope and direct laryngoscope. The aim of the current study was to compare IOP, hemodynamic parameters and throat pain in the use of videolaryngoscope and the direct laryngoscope.

Eligibility Criteria:
Inclusion Criteria:

* Elective Surgery under general anaesthesia

Exclusion Criteria:

* History of Glaucoma
* History of hearth disease
* History of Alzheimer
Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease

The researchers have worked to create consensus recommendations among national efforts to help with the transition and coordination of care for preterm infants with lung disease around discharge from the neonatal intensive care unit to home. This study looks to evaluate implementation of the recommendations at Boston Children's Hospital and referring NICU's (Beth Israel Deaconess Medical Center and Brigham and Women's Hospital). Specifically, the research team will be looking at follow-up rates, healthcare utilization, and parental satisfaction/feedback with implementation of these guidelines.

Premature infants with bronchopulmonary dysplasia (BPD) have complex care needs around discharge. BPD affects up to 40% of former preterm infants born at \<28 weeks gestation, with about 10,000 new cases of BPD in the United States every year. Healthcare utilization in this population in the first two years of life is high, with increased hospitalizations, visits, and medication usage. Coordinated follow-up programs may help improve outcomes and reduce rates of hospitalization in this population. However, guidelines do not exist to identify which infants discharging from the NICU should be targeted for specialty follow-up for their respiratory disease, the time frame and format that this should occur, and which evaluations should be performed routinely around discharge.

This will be an implementation study, measuring outcomes 3 months prior and 3 months after enactment of a discharge bundle for preterm infants with BPD at local NICUs (Brigham and Women's Hospital, Beth Israel Deaconess Medical Center) who will be followed by Boston Children's Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants born \<32 weeks with at least mild BPD, defined as 28 days of respiratory support after birth.
* Efforts will be made to include a mix of infants with mild, moderate, and severe BPD, including infants discharged on oxygen.

Exclusion Criteria:

* Discharge to a location other than home.
* Infants with other congenital disease (cardiac, genetic, neurological) thought to contribute significantly to their respiratory disease.
Reduction of Bacterial Resistance With Inhaled Antibiotics in the Intensive Care Unit

The purpose of this study was :

* to determine the effect of inhaled antibiotics on airway bacteria in ventilated patients
* to determine the effect of inhaled antibiotics on respiratory infection

Double-blind randomized placebo controlled study examining the effect of aerosolized antibiotics on respiratory infection signs and symptoms and on bacterial eradication and resistance.

Systemic antibiotics are administered by the responsible physician

Eligibility Criteria:
Inclusion Criteria:

* be on mechanical ventilation greater than 3 days
* greater than or equal to 18 years and survival greater than 14 days
* organisms on Gram stain with increasing purulent secretions

Exclusion Criteria:

* pregnancy
* allergy to drugs administered
18F Sodium Fluoride PET/CT in Acute Aortic Syndrome

The purpose of this study is to determine whether Sodium Fluoride imaging (using Positron Emission Tomography-Computed Tomography - PET-CT) is able to predict disease progression in acute aortic syndrome.

Acute Aortic Syndrome encompasses multiple aortopathies, including aortic dissection, intramural haematoma and penetrating aortic ulcers. Acute aortic syndrome has a three year mortality approaching 25%. To date, other than the initial aortic diameter, there are no accurate methods of establishing the risk of disease progression in patients with acute aortic syndrome.

In vascular disease, microcalcification occurs in response to necrotic inflammation. Using computed tomography and positron emission tomography (PET-CT), early microcalcification can be identified using uptake of the radiotracer 18F-sodium fluoride. This can identify high risk-lesions in the aorta, coronary and carotid arteries, and appears to be indicative of necrotic and heavily inflamed tissue. In abdominal aortic aneurysms, 18F-sodium fluoride binding predicts aortic expansion and the risk of aneurysm rupture or requirement for surgical repair.

The study investigators, therefore, propose to evaluate the ability of 18F-sodium fluoride to identify regions of necrotic inflammation in acute aortic syndrome to predict aortic expansion and disease progression.

Control patients with a normal calibre aorta will be recruited from the National Abdominal Aortic Aneurysm Screening Programme and Vascular Out-Patient Clinics. Patients with acute aortic syndrome and chronic aortic disease will undergo clinical assessments and 18F Sodium Fluoride PET/CT scans at baseline and 12-months. Clinical follow-up will continue for up to 3 years from recruitment.

Eligibility Criteria:
INCLUSION CRITERIA:

Patients with Acute Aortic Syndrome or Chronic Aortic Disease:

* A diagnosis of acute aortic syndrome as defined as per the European Society of Cardiology guidelines on the management of aortic disease a compatible clinical presentation with CT or magnetic resonance imaging confirming acute aortic syndrome.
* Adults over the age of 25 years
* Participants who have had previous open or thoracic endovascular aortic repair (TEVAR) are eligible to participate in the study.

Healthy Controls:

* No previous diagnosis of aortic disease
* Over the age of 55 years

EXCLUSION CRITERIA:

* The inability of patients to undergo PET/CT scanning
* Chronic kidney disease (eGFR ≤ 30 mL/min/1.73 m2)
* Major or untreated cancer
* Pregnancy
* Allergy or contra-indication to iodinated contrast
* Inability or unwillingness to give informed consent
Diabetes-specific Formula (DSF) in Individuals With Type 2 Diabetes

A randomized, controlled, crossover design with three treatments to determine the effects of diabetes-specific formula on glycemic control in individuals with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

1. Has type 2 diabetes as evidenced by use of oral antihyperglycemic medication(s).
2. BMI \> 18.5 and ≤ 35.0 kg/m2.
3. Weight stable.
4. Male or non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
5. If on chronic medication, the dosage to be constant for at least two months prior to screening visit and to maintain the medication and dose throughout the study.
6. Willing to follow the protocol throughout the study.
7. At least a two-week washout period between completion of a previous research study and their start in the current study.
8. Willing to refrain from taking non-study diabetes-specific formulas over the course of the study.
9. Voluntarily signed and dated an Informed Consent Form (ICF) prior to any participation in the study.

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

1. Has a screening HbA1c level \< 7% or ≥ 10%.
2. Uses exogenous insulin for glucose control.
3. Has confirmed type 1 diabetes and/or had history of diabetic ketoacidosis.
4. Has current infection, inpatient surgery or received systemic corticosteroid treatment in the last 3 months; or received antibiotics in the last 3 weeks.
5. Has active malignancy.
6. Has significant cardiovascular event within 6 months prior to study entry or history of congestive heart failure.
7. Has end stage organ failure or was post organ transplant.
8. Has a history of renal disease or severe gastroparesis.
9. Has current hepatic disease.
10. Has had bariatric surgery including gastric balloon; history of gastrointestinal disease or intestinal surgery that can interfere with consumption or digestion or absorption of study product.
11. Has a chronic, contagious, infectious disease.
12. Has eating disorder, severe dementia or delirium, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures.
13. Taking any herbals, dietary supplements or medications other than allowed anti-hyperglycemic medications, during the past four weeks prior to screening visit that could profoundly affect blood glucose or appetite.
14. Uses diabetes-specific formula(s) defined as more than one eating occasion per week in the last three months.
15. Has clotting or bleeding disorders.
16. Participates in another study that has not been approved as a concomitant study by Abbott Nutrition.
17. Has allergy or intolerance to any ingredient in the study product.
Evaluating a Mobile Phone Intervention

This clinical trial intends to study the efficacy of a mobile phone delivered intervention in reducing depression-related rumination.

Here we propose to test a novel intervention to help individuals manage their depressive rumination. The intervention is based on a just-in-time, adaptive-intervention (JITAI) design. A JITAI is "an intervention designed to address the dynamically changing needs of individuals via the provision of the type/amount of support needed, at the right time, and only when needed ." This study is also to address one major concern regarding designing JITAI interventions: the burden on participants in having to be engaged with the intervention through diaries, self-reports, and other forms of assessment procedures daily. To reduce this burden, we first pilot test an interactive narrative form. An interactive narrative is an essential form of storytelling that involves certain interactive features such that audiences or readers of the story can have the feeling that they are actively engaging in certain forms of interactions with the story characters.

To test the efficacy of such an intervention, there will be a one-month three-arm clinical control trial to reduce depressive rumination. There are three conditions: a JITAI interactive narrative condition, a non-narrative JTIAI condition, and a wait-list control condition. This study could contribute to our knowledge in designing more effective interventions in curbing depression using mobile technology. It can also advance our theoretical knowledge of the role of interactive narratives in reducing user burden in mobile health.

Eligibility Criteria:
Inclusion Criteria:

* Participants who have a current self-reported clinical diagnosis of being depressed ( mild to moderate depression and major depressive disorder)
* Participants should be 18 or older.
* Participants should have a working smartphone and daily access to the internet.

Exclusion Criteria:

-Participants who do not have regular access to the internet and a smart phones will be excluded.
Mind The Gap - Crossing Borders Study

Rationale: A big step forward and great opportunity to improve overall efficacy of bronchoscopic lung volume reductioen is to combine treatment modalities aiming to close the dependent collateral channels and then proceed with EBV therapy to induce lobar collapse, and thus maximal treatment effect.

Objective:

Primary objective:

1. To investigate the feasibility of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment.

   Secondary objectives:
2. To investigate the safety of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment.
3. To investigate the effectiveness of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of emphysema with a treatable target for endobronchial valves (Zephyr).
2. Subjects of both genders of at least 35 years of age at the time of the baseline visit.
3. Understand and voluntarily sign a patient informed consent form.
4. 15 % predicted ≤ FEV1 ≤ 50% predicted.
5. RV ≥ 175% predicted, and TLC ≥ 100% predicted and RV/TLC ≥ 55%.
6. 6MWD ≥ 140 meters.
7. Dyspnea score of ≥2 on the mMRC scale of 0-4.
8. Non-smoker \> 6 months prior to signing the informed consent.
9. Chartis CV positive between target and ipsilateral lobe

Exclusion Criteria:

1. Evidence of active pulmonary infection.
2. Evidence of clinically significant bronchiectasis.
3. History of more than 3 exacerbations with hospitalizations over the past 12 months.
4. Myocardial infarction or other relevant cardiovascular events in the past 6 months.
5. Prior lung surgery, Lung volume reduction surgery, lung transplantation, lobectomy, or pneumonectomy.
6. Prior endoscopic lung volume reduction.
7. Unstable pulmonary nodule requiring follow-up
8. Pregnant of nursing women.
9. Hypercapnia defined by PaCO2 \> 8.0kPa, or Hypoxemia defined by PaO2 \< 6.0kPa, both measured on room air.
10. Any disease with high probability of mortality within 24 months.
11. Patient is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as LMWH or coumarins), which cannot be stopped periprocedural.
12. Patient was involved in other pulmonary drug studies within 30 days prior to this study.

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Investigation Drug-drug Interaction Between Dabigatran and Clarithromycin

Dabigatran (Pradaxa ®) is a new oral anticoagulant. It is used to prevent venous thromboembolism in orthopedic surgery and has recently demonstrated efficacy and safety at least as good as anticoagulants in the prevention of thromboembolism in atrial fibrillation and the treatment of venous thromboembolism. It is administered with fixed dose and does not require laboratory monitoring because of the low inter and intra individual pharmacokinetic (PK) and pharmacodynamics (PD) of dabigatran. However, the bioavailability of dabigatran is very low (6.5%) and is controlled by an efflux protein, P-GP. This molecule has a genetic polymorphism. The inhibition of this protein can cause a significant increase in intestinal absorption of dabigatran and expose patients to a risk of bleeding by overdose. Two major drug interactions have been identified : quinidine (cons-indication) and amiodarone (precautions). It is likely that other interactions exist and can be clinically significant in patients not selected such as testing. The development of tools to study the influence of P-GP on the PK and PD of dabigatran is therefore interesting. As the P-GP has a genetic polymorphism, the study of the latter is an important element in the detection of drug interactions. In this sense, clarithromycin, a potent inhibitor of P-GP is a good model to evaluate the primary mechanism of drug interaction of dabigatran and optimize the experimental design of studies to be conducted.


Eligibility Criteria:
Inclusion Criteria:

* affiliated or beneficiary of a social security category
* having signed the inform consent form
* having signed the genetic consent form
* weight between 60 and 85 kg
* normal clinical exam
* normal biological exam

Exclusion Criteria:

* contra-indication to dabigatran
* contra-indication to clarithromycin
* previous history of psychiatric disease, or antidepressant treatment, or convulsion, or hemorrhagic disease
* smoker
* peptic ulcer
* severe liver disease
* severe kidney failure
* previous surgery within one month
Evaluation of Knowledge About Fever After Consultation in the Pediatric Emergency Department

The purpose of this study is to evaluate the effect of an information brochure on parent / legal guardians' knowledge of what to do about their child's febrile episode after a pediatric emergency department visit.

Single-center randomized controlled trial.

Fever is a common symptom of viral or bacterial infection in pediatrics. Previous studies using both qualitative and quantitative methods have established that intervention with parents/legal guardians on fever management decreases their worry and anxiety related to their child's occurrence of a febrile episode, limits unwise use of antipyretic medication (Walsh, 2006; Walsh, 2008; Peetom, 2017), but also reduces the use of emergency room or telephone medical consultations (Peetom, 2017).

The majority of visits for febrile conditions in children over 3 months of age are avoidable and do not require emergency and/or hospital care. Mistaken beliefs and lack of knowledge about what to do in the event of a febrile episode lead parents to consult a hospital emergency room for their child, which can have an impact on emergency room overcrowding.

The proportion of emergency room visits for febrile conditions assessed by the Intake and Referral Nurse (IOR) as not requiring urgent care raises questions about parents'/legal guardians' knowledge of fever, its monitoring, and what to do during a febrile episode.

The aim of our study is to evaluate parents' knowledge of fever and the appropriate course of action during a febrile episode in a pediatric emergency department of a Parisian university hospital by comparing standard management practices with the knowledge provided by an information brochure.

Eligibility Criteria:
Inclusion Criteria:

* Be of legal age
* Be the parent/legal guardian of a child aged between 3 months and 15 years,
* A child with a fever \> 38°celsus on arrival at the emergency room (measured by electronic thermometer rectally for children under 2 years of age or axillary/oral for children over 2 years of age),
* Severity of care rating by the IOA grade 4 (non-emergency care)
* Parent affiliated to a social security system or entitled to it
* Parent under "AME" French social security system
* Parent informed and having signed the consent

Exclusion Criteria

* Parent/legal guardian who does not speak or read French,
* Child with a pathology that does not allow for rectal temperature taking
* Parent/legal guardian with a visual impairment that prevents reading the information note and/or the information brochure.
* Parent / legal guardian under guardianship