cyrilzakka/clinical-trials huggingface dataset:
Web System for Engaging Families & Doctors in Continuous Asthma Quality Improvement

Asthma, one of the most common pediatric illnesses, is optimally managed according to National Heart Lung and Blood Institute (NHLBI) guidelines yet this is not often done in primary care. This project is to develop and test the effects of using a module for guideline based care in the Child Health and Development Interactive System (CHADIS) online system by prompting and incorporating patient symptom/control and adherence data from standard questionnaires to inform visits and providing automated patient specific education and Asthma Action Plans in individual Care Portals.

We will complete the formative work collecting professional opinion to create and pilot the initial CHADIS Asthma Intervention module (CHADIS-AI), an innovative decision support system. CHADIS-AI content will be assembled and vetted by asthma experts and primary care providers (PCPs). Parent and teen focus groups will vet the content and language of the adherence materials and Care Portal. A system will also be established for points for patient participation, to give clinicians Maintenance of Certification (MOC) credit, and ongoing run chart reports of their patients' asthma status for continual Quality Improvement (QI) feedback. The resulting system will be pilot tested and refined by clinician feedback. Practices will be randomly assigned to intervention vs control. Control practices will use CHADIS for asthma care without the A-I module. Intervention practices will be further randomized to have remote coach support for patients or not. Outcomes will be examined of asthma severity/control, match of severity with guideline based medication management, numbers of Emergency Department (ED) visits, hospitalizations and oral steroid use. Effect of remote coaching will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Asthma diagnosis

Exclusion Criteria:

* Not English or Spanish speaking
Ultrasonographic Parameters in Prediction of Difficult Laryngoscopy in Non-suspected Difficult Airway Patients

This study aims to evaluate the ultrasonographic parameters (distance from skin to epiglottis (DSE) and distance from skin to vocal cords (DSVC)) as preoperative predictors of difficult laryngoscopy in non-suspected difficult airway patients undergoing elective surgery.

Airway management is an integral part of general anesthesia. It simply aims to secure the patient's airway and achieve adequate ventilation and oxygenation for the patient undergoing surgery under general anesthesia. Unsuccessful airway management due to the unexpected difficulty in laryngoscopy is a life-threatening situation and may lead to morbidity and mortality.

Many conventional clinical tests are used in preoperative airway assessment such as modified Mallampati classification, Thyro-mental distance, inter-incisor distance, cervical mobility, and neck circumference, which are used to predict difficulty in the airway, but they have limited value and low sensitivity and specificity. Difficult laryngoscopy cannot be always predicted based on the preoperative assessment by conventional clinical tests. Some patients are thought to have an easy airway by clinical tests, but they show an unexpected difficulty in the laryngoscopy.

The laryngeal view of the patient can be assessed and graded during direct laryngoscopy using the Cormack and Lehane grading scale and its modification that describes the laryngoscopy as easy or difficult.

Ultrasonography is a valuable promising tool for preoperative airway evaluation through identifying important sonoanatomy of the upper airway such as epiglottis, thyroid cartilage, and vocal cords.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 - 65 years.
* Both sexes.
* Patients who aren't suspected to have a difficult airway after preoperative airway assessment by conventional clinical tests such as modified Mallampati classification (MMC), thyromental distance (TMD), inter-incisor distance (IID), cervical mobility (CM), And neck circumference (NC).
* American society of anesthesia (ASA) I, II, and III physical status.
* Scheduled for elective surgery under general anaethesia.

Exclusion Criteria:

* Patients with maxillofacial injury and airway trauma.
* Patients with a history of previous difficult intubation.
* Patients with anatomical abnormalities.
* Neck scarring, swelling, or burn.
* Pregnancy.
* Obesity.
Sucrose-sweetened Beverage in African-American and Caucasian Women.

The main objective of this pilot study is to measure changes in metabolic risk factors of cardiovascular disease and type 2 diabetes in response to sugar-sweetened beverages in African-American and non-Hispanic white women.

This is a dietary intervention during which participants will consume a SSB daily, with each meal for two weeks. At the beginning and end of the two-week intervention, participants will have blood drawn under fasting and postprandial (after a meal) conditions for the measurement of lipid risk factors associated with cardiovascular disease. Participants will also undergo an oral glucose tolerance test (OGTT) to assess insulin sensitivity. All sugar-sweetened beverages will be provided.

Eligibility Criteria:
Inclusion Criteria:

* BMI 25 - 35 kg/m2

Exclusion Criteria:

* Does not identify as African-American or non-hispanic White
* Glucose intolerance (fasting glucose \>100 mg/dl)
* Evidence of liver disorder (AST or ALT \>200% upper limit of normal range)
* Evidence of kidney disorder (\>2.0mg/dl creatinine)
* Evidence of thyroid disorder (out of normal range)
* Systolic blood pressure consistently over 140mmHg or diastolic blood pressure over 90mmHg
* Triglycerides \> 150mg/dl
* LDL-C \> 130mg/dl
* Hemoglobin \< 8.5 g/dL
* Pregnant or lactating women
* Current, prior (within 12 months), or anticipated use of any hypolipidemic or anti-diabetic agents PROTOCOL TITLE: The Effects of Sucrose Beverage on African-American and Caucasian Women (SAAC) Study Page 4 of 18 Revised: November 27, 2013
* Use of thyroid, anti-hypertensive, anti-depressant, weight loss medications or any other medication which, in the opinion of the investigator, may confound study results
* Use of chronic corticosteroids (everyday use for a month or longer)
* Use of tobacco
* Strenuous exerciser (\>3.5 hours/week at a level more vigorous than walking)
* Surgery for weight loss
* Diet exclusions: Food allergies, special dietary restrictions, food allergies, routine consumption of less than 3 meals/day, routine ingestion of more than 2 sugar-sweetened beverages or 1 alcoholic beverage/day, unwillingness to consume any food on study menu
* Veins that are assessed by the CCRC R.N.s as being unsuitable for long-term infusions and multiple blood draws from a catheter
* Any other condition that, in the opinion of the investigators, would put the subject at risk
* We will exclude individuals from each of the following special populations:

  * Adults unable to consent
  * Individuals who are not yet adults (infants, children, teenagers \< 18 years)
  * Pregnant women
  * Prisoners
Treatment of Proximal Humeral Fractures

This trial is designed to compare head-to-head conservative with operative treatment in 2 stratum. Stratum 1: In 2 part fractures the comparison is between conservative treatment and operative treatment with plate fixation with Philos. Stratum 2: In multi-fragmented fractures (MFF) meaning 3 and 4 part fractures, the comparison is between conservative treatment, operative treatment with Philos plate and operative treatment with Epoca prosthesis. Subgroup analysis will be performed in an effort to obtain limit values for specific treatment of different age and fracture groups. A cost-effectiveness analysis and comparison between different treatment modalities will be carried out. The primary outcome measure will be the DASH score and the secondary outcome measure the EQ-5D value. Recruitment period is 3 years and follow-up 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Low energy proximal humeral displaced (more than 1 cm or 45 degrees) 2 part fracture where fracture line emerges through the surgical (or anatomical) neck
* Low energy proximal humeral displaced (more than 1 cm or 45 degrees) 3 or 4 part fracture

Exclusion Criteria:

* Refuse to participate the study
* Less than 60 years old
* Non-independent
* Dementia and/or institutionalized
* Does no understand written and spoken guidance in either Finnish or Swedish
* Pathological fracture or previous fracture in the same proximal humerus
* Serious intoxicant dependent, eg. In first aid breathalyzer shows more than 2‰
* Other operational injury in the same upper limb
* Major nerve injury (eg. Complete radialis- or delta palsy)
* Open fracture
* Multi-trauma or -fractured patient
* Fracture dislocation or head splitting fracture
* Undisplaced fracture
* Isolated tuberculum fracture
* Fracture has no precondition to ossify by conservative treatment (no bony contact between fracture parts or the humeral shaft is in contact with the articular surface)
* Treating surgeon considers patient unsuitable to attend the study on medical basis
* Cuff-arthropathy
Sensenbrenner Clinical Study

Sensenbrenner syndrome, also known as cranioectodermal dysplasia (CED), is a rare autosomal-recessive disorder belonging to the ciliopathy group of diseases. It is characterized by a facial dysmorphism, abnormal bone development and ectodermal defects including dental anomalies. CED is a heterogeneous condition with significant phenotypic and molecular variability, whose spectrum may include cases of renal impairment, hepatic fibrosis, retinitis pigmentosa and/or brain anomalies. In many cases, patients develop chronic kidney disease (CKD) due to nephronophthisis between 2 and 6 years of age. The aim of this retrospective study is to better understand the characteristics of this syndrome and to find prognostic factors of CKD. We make the hypothesis that an early diagnosis of the syndrome would lead to a better global management of patients (quality of life, delayed onset of end-stage renal disease).


Eligibility Criteria:
Inclusion Criteria:

* Boys and girls.
* Aged 3 to 18 years old.
* Subjects with a Sensenbrenner's syndrome diagnosis and followed from 2005
* Parents/ legal guardian must provide non opposition prior to participation in the study

Exclusion Criteria:

* Patients whose parents / legal guardian have object to using the data usually collected for care
Fluid Investigation Colloid vs Crystalloid Reg. Renal Hemodynamics and Function

Comparing the effects of crystalloid versus colloid fluid resuscitation in CABG patients postoperatively regarding renal blood flow, glomerular filtration rate and renal oxygen demand.

Due to blood loss and SIRS postoperative hypovolemia is a usual feature after CABG surgery. Substantial controversy persists regarding the best choice of fluid to be used for resuscitation in this setting regarding renal function and oxygen supply-demand matching. In our study we aim to investigate differences in functional renal parameters by dividing patients postoperatively in two groups, substituted either with crystalloid fluid, Ringer-Acetat, 20 ml/kg or colloid, HES 6% (130/0,4) 10 ml/kg under 20 minutes. Central and renal hemodynamics will be measured before (baseline) and after fluid administration by blood sampling and thermodilution in both pulmonary artery catheter and renal vein catheter. Measurement endpoints will mainly consist of central hemodynamics, renal blood flow, GFR and renal oxygen extraction rate which we aim to compare between groups.

Eligibility Criteria:
Inclusion Criteria:

* elective fast track CABG patients, postoperative

Exclusion Criteria:

* hemodynamic instability
* preoperative renal impairment
* major postoperative bleeding
A Dose Escalation Trial of an Intravitreal Injection of Sirna-027 in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

The purpose of this study will be to assess the safety and tolerability and dose-limiting toxicity of a single intravitreal injection of Sirna-027 (AGN211745) and to assess the anatomical changes in the retina, changes in CNV, and changes in visual acuity. Escalation to the next dose cohort will be completed following minimum of 2 weeks follow-up. Patients will be monitored intensively for three months, and then followed-up for safety up to 24 months post-injection.


Eligibility Criteria:
Inclusion Criteria:

* Active AMD with Subfoveal CNV (classic and/or occult CNV)
* CNV lesion thickness \>/= 250um by OCT assessment
* Visual acuity in study eye of \</= 20/100 but not worse than 20/800
* Not eligible for or refused standard treatment

Exclusion Criteria:

* Females of childbearing potential
* Other causes of CNV including pathologic myopia, the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis
* Any intraocular surgery or treatment of AMD with Visudyne within 3 months of study entry
* CNV lesion \>/= 12 MPS disc area
Epidemiological Monitoring of COVID-19 Patients Hospitalized on Reunion Island

The island of Reunion, a French overseas department of 860,000 inhabitants, located in the Indian Ocean (OI) zone, recorded its first case of COVID-19 on March 11, 2020. The epidemic, which was described as not very severe during the year 2020 in Reunion was much more intense and more deadly in 2021, with the arrival of the new variants (South African and Indian) and exploded at the beginning of the year 2022 (variant Omicron).

Reunion has a specific island context both climato-geographically and demographically. Indeed, this French island located in the southern hemisphere in the middle of the Indian Ocean (OI) has a tropical climate and a multi-ethnic population, younger than in mainland France (16% are over 60 years old). It is also marked by a higher prevalence in the general population of certain risk factors, such as obesity (11%) and type 2 diabetes (\>10%), recognized as factors favoring severe clinical forms of COVID-19. as well as "persistent COVID-19".

This study will allow the constitution of a large-scale French cohort located in a closed overseas territory to provide answers to local specificities and to the management of the epidemic in the territory.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* having been hospitalized at the University Hospital Center (CHU) of Reunion (minimum of one night in the hospital)
* with a positive diagnosis of COVID-19 (positive RT(reverse transcription)-PCR(Polymerase Chain Reaction) SARS-CoV-2 on a nasopharyngeal swab or positive serology or confirmed diagnosis in the medical file)
* registered in the COVIDEPI database
* whose telephone numbers are available in the computerized patient file
* residing on the island of Reunion
* knowing how to understand and speak French

Exclusion Criteria:

* deceased
* opposing the use of their data
* deprived of liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or curators
Study Of ATRN-119 In Patients With Advanced Solid Tumors

The purpose of this study is to assess the safety and effectiveness of ATRN-119 through the performance of a Phase 1/2a, open-label, safety, PK, and preliminary efficacy study of oral ATRN-119 in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* DNA damage response (DDR) mutations documented in the past medical record or confirmed during the screening period.
* Measurable disease defined by RECIST 1.1.
* Life expectancy ≥ 3 months.
* Subject must be capable of oral administration of study medication.

Exclusion Criteria:

* Patient has had a cytotoxic chemotherapy, immunotherapy, radiotherapy or other targeted therapies within 4 weeks.
* Surgical procedure performed within 7 days prior to first scheduled dose of ATRN-119.
* Concomitant treatment with strong inhibitors or inducers of CYP3A4 and CYP2D6.
* Known human immunodeficiency virus infection (HIV).
* Subjects with active viral or bacterial infections and/or receiving systemic antibiotics or anti-viral medications.
* Current or past diagnosis of leukemia within the past 5 years.
* Prior radiotherapy at the target lesion unless there is evidence of disease progression.
* Known CNS metastases or clinical evidence of CNS involvement that is not stable for previous 1 month by radiology documentation (magnetic resonance imaging \[MRI\] brain).
* History of non-malignant gastronintestinal (GI) bleeding, gastric stress ulcerations, or peptic ulcer disease within the past 3-months.
* Patient has uncontrolled hypertension at time of enrollment.
* Complete left bundle branch block (LBBB), bifascicular block (right bundle branch block \[RBBB\] with either left anterior hemiblock or left posterior hemiblock).
* Any clinically significant ST segment and/or T-wave abnormalities.
* Myocardial infarction or unstable angina pectoris within 6 months prior to starting study medication.
Evaluation of an Online Lifestyle Intervention in Mexican School Children During COVID-19 Pandemic

Introduction: School closures due to the COVID-19 pandemic represent a risk factor for the development of childhood obesity due to the increase in unhealthy behaviors. Online lifestyle interventions in schoolchildren could help to mitigate this problem. However, to date, no randomized controlled trials have been performed to prevent obesity in schoolchildren during the COVID-19 pandemic. The aim of this study is to evaluate the effect of a 4-month online lifestyle intervention on the BMI Z-score of Mexican schoolchildren during the COVID-19 pandemic in an intervention group compared to a control group. Methodology: This is a pilot randomized controlled trial. Schoolchildren from a public elementary school in Hermosillo, Sonora, Mexico will be invited to participate. Participants will be randomized to an intervention group (online lifestyle intervention) or a control group. The intervention will include online sessions of nutrition education and physical activity and nutrition information for parents. The control group will receive a digital brochure with nutrition recommendations at the beginning of the study. The measurements will be performed at baseline and 4 months. The primary outcome will be the BMI Z- score. Secondary outcomes: waist circumference, fat percentage, nutritional knowledge, lifestyle parameters, retention, attendance at the program sessions, and acceptability of the intervention. The difference between groups in changes in the outcomes will be analyzed using an intention to treat analysis. The protocol was approved by the Research Ethics Committee of the University of Sonora Nursing Department (EPM-003-2020). Conclusion: The study will provide the first evidence of the evaluation of online interventions for the prevention of obesity in schoolchildren derived from a Randomized Controlled Trial. This information will be important for the development and implementation of other school-level obesity prevention programs around the world.


Eligibility Criteria:
Inclusion Criteria:

* 4th, 5th and 6th- grade students from the participating primary school.
* Have access to the internet.
* Have an electronic device (e.g. computer, laptop, tablet, or smart cell phone).
* Nutritional status: normal weight, overweight, or obesity (based on BMI-Z-score for age).

Exclusion Criteria:

* Have a medical condition that affects body weight.
* Takes medicine that affects body weight.
* Participating in another intervention that affects body weight.
* Have a condition that prevents physical activity.
* Withdrawal of informed consent or assent.
* Have a family member who is participating in the study.
Study of the Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seropositive Children

This study evaluates an investigational vaccine that is designed to protect humans against infection with respiratory syncytial virus (RSV) and is administered as drops in the nose. Specifically, the study analyzes the safety of, and the immune response to, the vaccine when administered to healthy children between the ages of 15 and 59 months who are seropositive to RSV.


Eligibility Criteria:
Key Inclusion Criteria:

1. Children aged 15-59 months
2. Good health based on history, physical examination and medical record review, without evidence or suspicion of chronic disease
3. Seropositive to RSV, as defined by serum neutralizing antibody titer above the threshold described in the study Analytical Plan
4. Written informed consent provided by parent(s)/guardian(s)

Key Exclusion Criteria:

1. Known or suspected chronic illness, particularly cardiopulmonary (including asthma or reactive airways disease), metabolic, hepatic, renal, or infectious (including recurrent or chronic sinusitis)
2. Known or suspected immunodeficiency
3. Household or close contact with anyone ≤ 6 months of age or with immunocompromised individual(s)
4. Nasal obstruction (including due to anatomic/structural causes, acute or chronic rhinosinusitis, or other causes)
5. Receipt of immunoglobulins, monoclonal antibodies and/or any blood products, or ribavirin within 3 months prior to study inoculation, or planned during study period
6. Receipt of an investigational RSV vaccine at any time
7. Any other condition that, in the judgment of the investigator, would be a risk to participant's safety and/or may interfere with study procedures or interpretation of results
A Study of Suboptimally Controlled Participants Previously Taking Injectable DMDs for RMS (CLICK-MS)

To evaluate the effectiveness, patient-reported outcomes (PROs) and safety of cladribine tablets in participants with relapsing forms of multiple sclerosis (RMS) including relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (aSPMS),who transition to cladribine tablets after suboptimal response to any injectable disease-modifying drugs (DMDs) approved in the United States (US) for RMS in a real-world setting.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants greater than or equal to (\>=)18 years
* Signed informed consent
* Have diagnosis of RMS including RRMS and aSPMS and satisfy the approved indication for cladribine tablets as per United States Prescribing Information (USPI)
* Have time since diagnosis of RMS of at least 12 months
* Had received their last previous injectable disease-modifying drug (DMD) for at least 3 months
* Have decided to initiate treatment with cladribine tablets during routine clinical care
* Meet criteria as per the approved USPI
* Have access to a valid e-mail address
* In the opinion of the Investigator, experienced suboptimal response (lack of effectiveness, intolerability, poor adherence) to injectable DMD treatment

Exclusion Criteria:

* Have been previously treated with cladribine in any dosing form
* Transitioning from previous injectable DMD solely for administrative reasons such as relocation
* Have comorbid conditions that preclude participation
* Have any clinical condition or medical history noted as contraindication on USPI
* Are currently participating in an interventional clinical trial
* Pregnant or breastfeeding women, women who plan to become pregnant or men whose partner plans to become pregnant during the cladribine treatment period
Effect of Different Scoring Systems on Mortality Rates and Length of Hospitalization in Cardiac Surgery Patients

Precise risk estimation of mortality in cardiac surgery patients is often difficult. Main objectives of this study is to calculate mortality probability by two different risk score system and to inquire effects of informing anesthesiologist and surgical team; of score of the patient; on length of hospitalization and intensive care and also on actualized mortality.


Eligibility Criteria:
Inclusion Criteria:

* ASA anesthesia risk group 2-5 patients between 18-70 years of age and with planned cardiac surgery

Exclusion Criteria:

* Terminal malignant diagnosis, multiple organ failure, confirmed brain dead, mechanical ventilation dependent or planned transplantation patients