cyrilzakka/clinical-trials huggingface dataset:
Generating Evidence in ECMO Ventilation Strategies

The goal of this pilot clinical trial is to test if ICU level ventilator protocols are appropriate interventions to study differences in ventilator strategies for patients with acute respiratory failure supported by VV-ECMO. The main questions it aims to answer are:

* will clinicians closely follow different ICU ventilator protocols
* will different ICU ventilator protocols change the way that patients are treated.

Participants will be assigned to one of two ventilator protocols based on the month that they are first started on ECMO. Researchers will compare standard lung-protective ventilation to ultra-lung protective ventilation protocols to see how this changes how the ventilator is set for patients.

This is a pilot, open label, pragmatic cluster-crossover clinical trial testing the feasibility and exploring the clinical impact of ICU-level ventilator management protocols as interventions in patients with acute respiratory failure requiring support with extracorporeal membrane oxygenation (ECMO). The overall objective is to inform the design of a future pragmatic, cluster-randomized clinical trial. The investigators will do this by completion of the following aims:

Aim 1: Measure clinician fidelity to ICU-level ventilator management protocols for patients with ARDS treated with ECMO. Hypothesis: Clinicians will have high fidelity to ICU-level ventilator management protocols for patients with severe ARDS on ECMO. To test this hypothesis, the investigators will conduct a pilot cluster-crossover study. The Duke medical ICU will be treated as a single cluster of patients. This cluster will be assigned to a standard lung-protective ventilation protocol for patients treated with ECMO, and then crossover to an ultra-lung protective ventilation protocol. The investigators will record if patient ventilator settings adhere to the assigned protocol at the time of treatment. The proportion of patients whose ventilator settings adhere to the assigned protocol will be compared to an a priori defined threshold to indicate feasibility.

Aim 2: Explore the clinical impact of using different ventilator management protocols for patients with ARDS treated with ECMO. Hypothesis: Patients managed with standard lung protective ventilation will have shorter durations of ECMO and mechanical ventilation when compared with patients managed with ultra-lung protective ventilation. To test this hypothesis, the investigators will measure the duration of ECMO and mechanical ventilation for all patients enrolled in the study. The investigators will perform an exploratory analysis examining differences in these outcomes between the two treatment groups.

Eligibility Criteria:
Inclusion Criteria:

* All patients being treated with ECMO in the Duke University Hospital Medical ICU will be eligible

Exclusion Criteria:

* There are no exclusion criteria
Changes in Central Arterial Pressure When Comparing Nifedipine/Labetalol for Routine Hypertension Control in Pregnancy

To study central blood pressure changes caused by commonly used high blood pressure medications in pregnancy.

Central blood pressures in addition to pulse wave velocity will be attained prior to medication, and then every 30 minutes for 4 hours (total of 9 readings). Sphygmomanometer readings will be completed at the same time (total readings 9). These readings are all related to the study.

Nursing will have the opportunity to to record the routine sphygmomanometer readings for their routine vitals if they chose to do so.

Their participation will be complete after the 4 hour assessment is complete.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Women with hypertensive disease in pregnancy who are currently being treated with nifedipine xl or labetalol

Exclusion Criteria:

* Multiple pregnancy
* Currently on multiple anti-hypertension medications
* Narcotic use
* Irregular heart rhythms or arrhythmias
* Peripheral arterial disease, leg artery disease
* Reynaud's phenomena
* Intense cold/hypothermia
* If there is a wound at location of where central arterial cuff would be placed or tonometer for carotid assessment
* Known sensitivity to labetalol or nifedipine
* Severe tachycardia (\>120)
* Greater than 1st degree heart block
* Severe asthma
* Congestive heart failure or heart disease
* Lupus
* Inability to adequately monitor BP
* Currently receiving magnesium sulfate
Emotion Tracking Study for Residents

The proposed study will develop and pilot a fourteen-day assessment tailored for the high-demand schedule of residents through a smart phone intervention, EmoTrak.EmoTrak uses ecological measurement assessment (EMA), which solicits real-time user feedback at various time points across a series of days or weeks.

The investigators will perform a randomized controlled trial that compares residents, using EmoTrak with a wait list control group. After two weeks, the active control group becomes the treatment group. All participants will be evaluated four times from at baseline to two months. The measures to explore for any pre and post change are stress reduction on the emotional exhaustion scale of the Maslach Burnout Inventory (MBI) and improved resilience on the Perceived Stress Scale (PSS).

Eligibility Criteria:
Inclusion Criteria:

* Currently in Residency or Fellowship at UCSF

Exclusion Criteria:

* Not having an Iphone
Idiopathic Pulmonary Fibrosis and Serum Bank

Idiopathic pulmonary fibrosis (IPF) is the most common form of chronic idiopathic diffuse interstitial lung disease (DILD) in adults. It is a fibroproliferative, irreversible disease of unknown cause, usually progressive, occurring mainly from the age of 60 and limited to the lungs. IPF is a serious disease with a median survival rate at diagnosis of 3 years.

The aim of the study is to set up a biocollection of serum from patients in a context of idiopathic DILD and a possible or confirmed diagnosis of common interstitial lung disease by chest CT.

Patients will be recruited at the consultations of the Rennes Rare Lung Disease Competence Centre. These will be patients in stable condition or in acute exacerbation of IPF.

This study will initially focus on circulating serum CD163 markers, but a broader proteomics approach could be considered in a second phase to look for other markers of lung diseases.

Eligibility Criteria:
Inclusion Criteria:

* Patients seen on an outpatient basis and in stable or acute condition
* Patient over 18 years of age.
* The inclusion criteria will be those edited by the American Thoracic Society (ATS) and the European Respiratory Society (ERS) to diagnosis IPF

Exclusion Criteria:

* Patients who are unable or unwilling to sign the consent.
House Dust Mite Allergy Trial In Children

A research study of how house dust mite tablets work compared to placebo in children aged between 5 and 11 years and who have allergy to house dust mites (MATIC)

The trial aims to demonstrate efficacy of the House Dust Mite SLIT-tablet compared to placebo in children (5-11 years of age) with House Dust Mite allergic rhinitis based on the total combined rhinitis symptoms and medication score during the last 8 weeks of treatment.

In addition, the trial will evaluate safety and tolerability of the treatment, and assess whether treatment has an impact on asthma symptoms and medication use, immunological parameters, and rhinoconjunctivitis quality of life (QoL).

The trial is a randomised, parallel-group, double-blind, placebo-controlled multi-national phase III trial conducted in Europe and North America. The treatment period will be approximately 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 5-11 years
* A clinical history of HDM AR/C (Allergic rhinitis/rhinoconjunctivitis) (with or without asthma) and with allergic rhinitis symptoms despite having received allergy pharmacotherapy during the previous year prior to screening
* Have a certain level of AR (Allergic rhinitis) symptoms on at least 8 of the last 14 days of the baseline period
* Use symptomatic medication for treatment of HDM allergic rhinitis during at least 8 of the last 14 days of the baseline period
* Positive skin prick test (SPT) and IgE (Immunoglobulin E) to D. pteronyssinus or D. farinae at screening
* Lung function ≥ 70% of predicted value

Exclusion Criteria:

* Sensitised and regularly exposed to perennial allergens
* Any nasal or pharyngeal condition that could interfere with the safety or efficacy evaluation
* Asthma requiring treatment with high dose of inhaled corticosteroid
* A relevant history of systemic allergic reaction
Effect of Diving and Aquatic Exercises on Muscle Spasticity and Motor Function in Children With Spastic Cerebral Palsy

This study aims to evaluate the effect of diving and aquatic exercises on muscle spasticity and motor function in children with spastic cerebral palsy.

Cerebral palsy (CP) is a common neurological disorders that affect movement and muscle coordination in childhood. Hydrotherapy is one of the most popular supplementary treatments for children with neuro-motor impairments, particularly children with CP.

Hydrotherapy may be more suitable for children with CP because of the properties of water, and it may be more motivating for children than land-based exercise. Buoyancy makes it easier for children with moderate to severe mobility limitations to move in the water than to move and exercise on land.

Eligibility Criteria:
Inclusion Criteria:

* Age from 2 to 5 years.
* Both sexes.
* Children diagnosed with spastic cerebral palsy, categorized according to the Gross motor function classification system (GMFCS) levels IV, V.

Exclusion Criteria:

* Botulinum toxin treatment or surgery in the preceding three months.
* Botox injections before or during the application of the program.
* Dorsal rhizotomy.
An Observational Study On TheAccuracy Of Whole-Body Magnetic Resonance Imaging (Wb-Mri) ScreeningTo Predict Clinically Significant Diagnoses In General Population Subjects Interested In Proactive And Advanced General Preventive Healthcare.

This is a prospective, single-arm, observational study capturing data from whole-body magnetic resonance imagining (WB-MRI) from up to 100,000 male and female subjects 18 years of age or older recruited at multiple clinical sites within the United States. Study subjects must meet a set of inclusion and exclusion criteria. Potential subjects arriving at the study sites will be evaluated for enrollment. It is the Principal Investigator's (PI) responsibility to enroll only subjects who satisfy the inclusion/exclusion criteria. Recruitment can occur by subject presentation at the sites for elective standard screening, word-of-mouth, flyers, healthcare professional (HCP) referrals, advertisement online, or any other means, subject to approval by the associated institutional review board (IRB) or ethics committee (EC) when applicable.


Eligibility Criteria:
Inclusion Criteria:

* Each subject MUST:

  * Be\>=18 years of age at the time of enrollment.
  * Be able to read and understand provided procedural information for the study;
  * Be able and willing to follow all study procedures including proper breathing and body movement minimization while within the WB-MRI system;
  * Be willing and able to provide required clinical, demographic, medical history, and concomitant medications information;
  * Be able to provide financial payment in advance for reimbursement of the cost of the WBMRI acquisition procedure and interpretation;
  * Complete all required consent procedures.

Exclusion Criteria:

* Harbor within their bodies contraindicated medical devices including, but not limited to, implanted pacemakers, intracranial aneurysm clips, cochlear implants, drug infusion pumps, neurostimulators, bone growth stimulators, certain intrauterine contraceptive devices, non- MRI safe metals, etc.;

  * Self-certify that they are pregnant;
  * Be seeking to undergo WB-MRI as a subject in this study in lieu of other covered dedicated diagnostic imaging evaluations when such covered procedures represent more appropriate or standard-of-care procedures by context-specific clinical indication;
  * Be an employee of the study site or the sponsor;
  * Have a medical condition or serious intercurrent illness, or other circumstance that, in the Investigator's judgment, could jeopardize the candidate's safety as a study subject, or that could interfere with study objectives.
Reference Range Study for the Quantra QStat System

The objective is to determine the reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge.

This is a multicenter, prospective, observational study of a healthy adult population with normal coagulation function to determine the reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge. The threshold for the Clot Stability to Lysis (CSL) parameter will be determined from the CSL reference range.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years or older
* Subject is willing to participate and has signed a consent form
* Subject's laboratory coagulation test results at screening are within each test's normal reference range.

Exclusion Criteria:

* Subject is younger than 18 years
* Subject has a history of a coagulation disorder
* Subject is pregnant or lactating
* Subject is currently taking medications known to alter coagulation
* Subject has one or more laboratory coagulation test results outside of the normal reference range at screening
* Subject had a blood transfusion or surgery within the last month
* Drug abuse
* Excessive alcohol consumption
* Subject is unable to provide written informed consent
* Subject is incarcerated at the time of the study
* Subject previously participated in this study
Functional Recovery From Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19: Influence of Socio-Economic Status

In this study, the investigators are attempting to evaluate the influence of socio-economic factors on the functional recovery (physical and psychological) of patients who developed ARDS after a COVID-19 infection, with the aim of offering personalized medical and social follow-up and support measures in order to avoid medium- and long-term complications, which can result in handicaps, reduced quality of life, and a higher risk of death.


Eligibility Criteria:
Inclusion Criteria:

* Inpatient in ICU for PCR-proven SARS-VOC-2 infection regardless of specimen type
* Patient who received a chest CT scan in the initial phase of management (either just before or during hospitalization in the intensive care unit)
* Patient who has received invasive or non-invasive ventilatory support, or humidified and heated high-flow oxygen (HFO).
* ARDS meeting the criteria of the 2012 Berlin definition. For patients who have received only HFO, a flow rate at least equal to 50L/minute with a FiO2 strictly greater than 50% with a PaO2/FiO2 ratio less than or equal to 200 will be required for inclusion.
* Patient who gave oral consent after being informed about the conduct of this study.

Exclusion Criteria:

* Patient with limited autonomy prior to hospitalization in limited intensive care unit: walking distance of less than 50 meters, WHO classification status 3 and 4.
* Patient with a history of chronic respiratory failure as defined by the use of long-term oxygen therapy or non-invasive home ventilation, excluding patients with SAS and/or hypoventilation obesity syndrome.
* Patient with a history of central or peripheral neurological conditions limiting the patient's motor autonomy and the performance on gait tests or Pulmonary function Tests
* Patient refusing to participate
* Patient \< 18 years of age
* Patient not affiliated or not benefiting from national health insurance
* Patient under guardianship, curatorship or protected adult
* Patient unable to understand and consent to the research protocol

SECONDARY EXCLUSION CRITERIA

* Patient not showing up for visit at M6
* Patients who have not had all the examinations necessary to evaluate the main endpoint (Spirometry, DLCO, TM6 and CT)
Diagnostic Value of Heart-Fatty Acid Binding Protein and Ischemia Modified Albumin as Biochemical Markers on Non ST Segment Elevation Acute Coronary Syndrome at the Emergency Room.

Early diagnostic of non ST elevation coronary syndrome in patients admitted to the emergency room is difficult. Two news biochemical markers have been assessed and studies have suggested that heart fatty binding protein and ischemia modified albumin are early markers of myocardial necrosis and myocardial ischemia. The aim of the study is to analyse the predictive value of association of heart fatty binding protein and ischemia modified albumin for non ST segment elevation acute coronary syndrome diagnosis in the first hour of management in the emergency room.

Early diagnostic of non ST elevation coronary syndrome (ACS) in patients admitted to the emergency room is difficult. Two news biochemical markers have been assessed and studies have suggested that heart fatty binding protein and ischemia modified albumin are early markers of myocardial necrosis and myocardial ischemia.

Study objective: The aim of the study is to analyse the predictive value of association of heart fatty binding protein and ischemia modified albumin for non ST segment elevation ACS diagnosis in the first hour of management in emergency room.

Methods: In a prospective double blind study, initial heart fatty binding protein and ischemia modified albumin levels will be measured in consecutive patients admitted in the emergency room with chest pain and suspected non-ST elevation ACS. Data including history, physical examination, serial 12-lead ECG and troponin-I measurement at 0 and 6 hours after admission will be collected by the treating physician blinded to the result of the markers. Based on hospital diagnosis algorithm (troponin repeated measurements, treadmill test or other ischemia detection, coronarography if necessary) and follow-up at one month, patients will be classified as having or no non-ST elevation ACS by two independent physicians blinded to the results of markers. Sensitivity, specificity, positive and negative predictive values will be determined for each marker and in combined analyses.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients admitted in the emergency room with a primary complaint of chest pain evolving within 12 hours and suspected as acute coronary syndrome

Exclusion Criteria:

* patient younger than 18 years old, having an ST elevation on a 12-lead ECG, having an evident traumatic cause of chest pain or having severe communication problems
Occlusal Splints in the Treatment of Sleep Bruxism

Occlusal splints are employed in the treatment of sleep bruxism. These appliances decrease sleep-related actions and damages bruxism, like grinding, tooth-wear, headache, and temporomandibular joint disorders. Occlusal splints are produced both in hard and soft forms according to the used material.

In this study, it was aimed to evaluate the effect of occlusal splint type on the sleep quality and occlusal force parameters of patients with sleep bruxism.

Various splint designs have been used for the treatment of sleep bruxism that is made up of different materials: Hard and soft splints. Although, these splints have slightly different appearances and properties, in fact, scientific evidence supports both the use of hard and soft occlusal splints. Hard splints are more preferred when compared to soft ones, thus, oft appliances have been less documented in the scientific literature. However, some studies suggested the use of soft-resin splints that are easily fabricated and may be inserted at an initial appointment, dental clinicians may desire the use of soft appliances. One of the advantages of these appliances is they are easy to tolerable to the patient and comfortable. Additionally, these splints fit tightly and provide a flat plane during sleep.

Considering these advantages, the present study was designed to examine the effect of the use of different types of occlusal splints on the sleep quality and occlusal force of patients with sleep bruxism. For this purpose, the effect of two splints basically fabricated from two different materials were evaluated and compared. The null hypothesis was that the use of both occlusal splints would not change the values of sleep quality and maximum occlusal force of the patients with sleep bruxism.

Eligibility Criteria:
Inclusion Criteria:

- Healthy participants with complete permanent dentition.

Exclusion Criteria:

* Presence of a systemic disorder that could compromise the masticatory system (e.g., neurological disorders, epilepsy, cerebral palsy, among others),
* Systemic disorder or current use of drugs that could interfere, directly or indirectly, with muscle activity,
* Inappropriate behavior and/or refusal to cooperate with dental procedures and data collection,
* Tooth loss (except for third molars),
* Soft tissue abnormalities,
* Toothache report,
* Active periodontitis (presence of periodontal pockets involvement of the supporting tissues),
* Caries lesions,
* Use of orthodontic appliances,
* Use of dental prosthesis (fixed or removable partial).
* Subjects with moderate to severe malocclusions, diagnosed by using the Orthodontic Treatment Need Index (IOTN) (scores 5 or 6 - severe and extreme need for orthodontic treatment)
* Alcohol or drug abuse,
Testing the FLASHE Survey

Background:

- The Family Life, Activity, Sun, Health, and Eating (FLASHE) Survey is designed to look at health-related topics. It is being developed for the Department of Health and Human Services. Researchers want to see how easy or difficult the FLASHE survey questions are to understand and answer. They will interview parents and teenagers to test the survey questions.

Objectives:

- To test the FLASHE survey questions on teenagers and their parents.

Eligibility:

* Adolescents between 11 and 18 years of age.
* Parents of the participating adolescents.

Design:

* Participants will have a one-on-one interview to test the survey questions. The interview will last up to an hour and a half. Participants will be allowed to skip any questions that they do not wish to answer.
* Participants will receive financial compensation for their time.

The National Cancer Institute s (NCI) Division of Cancer Control and Population Sciences (DCCPS), Behavioral Research Program (BRP) proposes conducting formative research as an integral part of the development of a new data collection instrument, the Family Life, Activity, Sun, Health, and Eating (FLASHE) survey. Specifically, NCI proposes conducting cognitive testing with the objective of identifying potential sources of measurement or response errors within the questionnaires. Many of the questions are new questions that have not been previously tested, or previously-used questions that have never been used with a teenage population.

Eligibility Criteria:
* INCLUSION AND EXCLUSION CRITERIA:

The DCCPS contractor, Westat, will be conducting the study. Participants for the cognitive interviews will be recruited from the general population, and will include dyads of a parent or caregiver, and his/her teenage child between the ages of 11 and 18. Neither the contractor who will be coordinating the research (Westat) or NCI employees will be eligible to participate in the cognitive interviews. Westat will recruit respondents using a variety of methods including use of Westat s current database of potential participants and advertising on CraigsList in the local DC area under the Jobs postings within the subheading Et Cetera. Westat's digital media team will reach out to 100 local DC area (including lower Pennsylvania) publishers such as mommy and papi bloggers, health websites, giveaway publishers, and Facebook and Twitter users.