cyrilzakka/clinical-trials huggingface dataset:
Growing Up Formula Versus Nutritional Supplements: Effect on Catch up Growth, Micronutrient Status, and Solid Foods Intake in Toddlers With Mild or Moderate Malnutrition

This is a pilot study to test how a growing-up formula (GUF) compares to a common nutritional supplement (NS), which is regularly used to help toddlers (ages 12-36 months) gain weight. This study will look at whether GUF helps to increase solid food intake for children who are thought to be "picky eaters" and see the effects on growth compared with the NS. To date, it is not clear if GUFs help to increase intake of solid foods. Participants will be placed into one of the two study arms: Enfagrow (GUF) or Pediasure (standard NS).


Eligibility Criteria:
Inclusion Criteria:

Healthy toddlers 12-36 months of age with mild or moderate malnutrition will be defined by at least one of the following indicators:

1. Weight-for-length z-score between -1.0 and -2.9 for children less than 2 years of age using the WHO growth standards; or
2. BMI z-score between -1 to -2.9 for children between 2 and 3 years of age using the CDC growth standards; or
3. Middle upper-arm circumference (MUAC) z-scores between -1 to -2.9 using the WHO growth references; or
4. Percentage of median ideal body weight of 70-89% (using the 50th percentile of the aforementioned growth standards).

Exclusion Criteria:

* Toddlers currently on or with history of tube feeding or with chronic health conditions that influence eating (e.g., food allergies, genetic disorders or developmental disabilities, oral motor difficulties that require sensory or feeding therapy).
* Toddlers who were born at less than 34 weeks gestation, as they may have lingering feeding challenges.
* Toddlers with gastroesophageal reflux disease (GERD) requiring medications or hydrolyzed formula or any type of esophageal disorders will be excluded.
* Toddlers with a history of infant reflux will not be excluded. The PI will make this distinction after a detailed history and record review.
* Families who do not speak English or Spanish in the home.
* Toddlers with suspected malabsorption or conditions that increased metabolic demands such as congenital heart defects.
* Toddlers who have a diagnosed allergy to cow's milk.

The PI will use their clinical discretion to ascertain patient eligibility.
Red Cell Distribution Width Versus Presepsin (Soluble CD14) as a Prognostic Marker in Critically-ill Sepsis Patients

Presepsin (soluble CD14 subtype) is a novel marker with growing body of evidence supporting its accuracy and value for the diagnosis of sepsis. Patients with sepsis showed higher Prsepsin levels compared to those with SIRS. In addition the increase in Prsepsin levels correlates well with sepsis severity. Red cell distribution width variations are increased in a variety of medical conditions such as congestive heart failure, acute myocardial infarction, pulmonary embolism, pneumonia, critical illness, and cardiac arrest , and is a predictor of mortality in the general population. we aim to compare between Presepsin (soluble CD14) and RDW as prognostic markers in critically-ill patients with sepsis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 65 years.
* Appropriate clinical data to enable classification into sepsis or SIRS according to Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
* Written informed consent by the patient or guardian

Exclusion Criteria:

* No informed consent
* Renal failure
* Liver failure
* Hematologic diseases
* Neutropenia
* Malignancy
* Chemotherapy during the previous 90 days.
* Patients using antibiotics at presentation
Retrospectively Analyze the Risk Factors of VTE in 5774 Patients With Thoracic Trauma From 33 Hospitals in China, and Established a Risk Prediction Model

Retrospectively analyze the risk factors of VTE in 5774 patients with thoracic trauma from 33 hospitals in China, and established a risk prediction model

In order to explore the risk factors of VTE after acute thoracic trauma, we collected the diagnosis and treatment information of 5774 patients with thoracic trauma from 33 hospitals in China, retrospectively analyzed the risk factors of VTE in patients with thoracic trauma, and established a risk prediction model.

Eligibility Criteria:
Inclusion Criteria:

* admitted within three days of the chest trauma, VTE has not yet occurred, AIS score of thoracic injury was greater than or equal to 3, AIS score of other combined injuries was less than or equal to 2.

Exclusion Criteria:

* received preventive physical or chemical anticoagulation before admission, VTE occurred before admission
Non-Inferiority Study Comparing MINI WELL READY® and FineVision® in Patients With Cataract Surgery

Interventional, Multicentre, controlled, randomized, single blind, twoarmed non-inferiority trial

To evaluate the non-inferiority of the progressive extended depth of focus Intraocular Lens MINI WELL READY® in terms of visual performance, quality of vision and subjective outcomes versus the trifocal Intraocular Lens FineVision® after a follow up period of 2-6 months.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Bilateral cataract surgery required, no other ocular comorbidities
* Healthy corneas, not treated surgically
* Available for second-eye surgery within 1 week of the initial operation
* Spherical refraction between -8.00D and +6.00D
* Willing to adhere to the study visit schedule
* Normal anterior and posterior segments
* Clear intraocular media - other than cataract
* To benefit from a social security system before being enrolled
* Written informed consent consistent with local regulation research in human subjects

Exclusion Criteria:

* Any previous history of ocular trauma or prior ocular surgery (including previous cataract surgery and CLRIs)
* Ocular comorbidities determining potential postoperative Visual Acuity less than 0.50 decimal (0.3 logMAR)
* Expected to require retinal laser treatment
* A history of retinal detachment or predisposition for such disorder
* Psudoexfoliation
* Abnormal pupil size and position
* Pupil size \> 7 mm under mesopic condition
* Use of contact lenses 30 days before the preoperative visit
* Corneal warpage (e.g. Keratoconus, Pellucid Marginal Corneal Degeneration or Keratoglobus)
* Corneal astigmatism greater than 0.75D
* Zonular laxicity
* Absence of adequate capsular support for the implant of the intraocular lens in the capsular bag
* Microphthalmus
* Active ocular disease in the operative eye, for example, chronic uveitis, proliferative diabetic retinopathy, chronic glaucoma unresponsive to medication, corneal decompensation and corneal endothelial cell insufficiency (such as Fuch's endothelial dystrophy)
* Suspected microbial infection
* Irregularities and capsulorexis decentralization
* Surgical difficulties that may increase the risk of complications such as persistent bleeding, significant iris damage, an uncontrollable intraocular hypertonia, or damage due to significant vitreous loss
* Patients in whom the intraocular lens may interfere with the ability to observe, diagnose or treat diseases of the posterior segment
* Patients in whom neither the posterior capsule nor the zonula can provide adequate support to the lens
* Subjects with any systemic disease that could increase operative risk or confound the outcome
* Pregnant or lactating or planning a pregnancy at the time of enrolment
* Vulnerable subjects (children \<18 years, people in guardianship or trusteeship or inability to give an informed consent)
* Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days
Changes in Vaginal, Cervical and Uterine Microflora With Levonorgestrel Intrauterine Device Placement

The goal of this study is to examine changes in the bacterial ecology and inflammatory markers of the female genital tract with levonorgestrel intrauterine device placement.

The specific research objectives of this project include:

1. Characterization of vaginal, cervical and uterine bacterial species and communities prior to and after LNG IUD placement using bacterial DNA microarray analysis. Samples will be collected up to 1 week before and 2 months after IUD insertion.
2. Characterization of vaginal, cervical and uterine inflammatory cytokine milieu prior to and after LNG IUD placement using human RNA microarray analysis. Samples will be analyzed from up to one day before and three weeks after IUD insertion.
3. Establish a tissue bank of vaginal, cervical and uterine specimens for future research.


Eligibility Criteria:
Inclusion Criteria:

* Not currently pregnant
* No use of hormonal birth control for at least three months prior to enrollment
* Desiring levonorgestrel IUD for birth control
* Greater than 6 months postpartum
* Greater than 6 weeks after miscarriage
* No antibiotic use in the past 6 weeks

Exclusion Criteria:

* Uterine Abnormalities
* Current use of hormonal contraceptives or use less than 3 months ago
* Unexplained vaginal bleeding
* Irregular menses
* Cervical dysplasia
* Cervical or vaginal infection in the last 6 weeks
* Douching within the week prior to sample collection
* Use of vaginal lubricants within the week prior to sample collection
Online Multi-component Psychological Intervention for Depression, Anxiety and Well-being in 7 Countries

This study evaluates the effectiveness of an online Multi-component psychological intervention, that is focused on providing self-support to the population of 5 Latin American countries and 2 European Countries. The objectives of the intervention are: 1) To reduce the symptoms of anxiety and depression in the adult population, 2) To increase the levels of subjective well-being.

Anxiety and depression at clinically significant levels are associated with suicidal thoughts and behaviors. Furthermore, it is associated with the health-disease process in two ways: 1) variables that influence behavior, hindering people's healthy habits and promoting the development of unhealthy behaviors; 2) anxiety and depression affect the psycho physiological activation of people, which affects their immune system.

Considering the damage that can occur by not addressing incipient problems of anxiety and depression, it is important to develop interventions with preventive purposes. Thus, the online modality of the intervention presented in this project can benefit a significant number of people in Mexico, Ecuador, Chile, Brazil, Peru, the Netherlands and Spain. The online modality of psychological interventions is a viable treatment alternative, especially for those people who do not have any psychological treatment within their reach.

The participants will be measured at pre, middle treatment, post assessment and two follow ups of 3 and 6 months. The self-report measures will include the following Psychometrics:

1. General Anxiety Disorder with 7-items (GAD-7)
2. Center for Epidemiologic Studies Depression Scale" in its revised version (CESD-R).
3. Perceived Stress Scale (PSS-10)
4. Pittsburgh Sleep Quality scale (PSQI)
5. Action Acceptance Questionnaire II (AAQ-II)
6. The Satisfaction with Life scale
7. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
8. Perceived Deficits Questionnaire (PDQ-5)
9. The Positive and Negative Affect Schedule (PANAS)
10. Opinion on the treatment.
11. System usability scale.
12. Client Satisfaction Questionnaire (CSQ-8S)
13. The Telehealth Usability Questionnaire (TUQ)

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Completion of 100% of the basal evaluation through the form
* Residence in one of the countries participating in the study
* Fluency/ proficiency in Spanish (Mexico, Ecuador, Chile, Peru and Spain), Dutch or English (Netherlands) or Portuguese (Brazil), depending on the country.

Exclusion Criteria:

* Participants with severe symptoms of anxiety and/or depression, or they report a diagnosis of a depression and/or an anxiety disorder.
* Participants who self-report having another diagnosed psychiatric comorbidity: personality disorder, psychotic disorder, bipolar disorder, Attention-Deficit/Hyperactivity Disorder, or others.
* Participants taking medication for symptoms of depression and/or anxiety
Cocaine Use Reduction and Health

Reduced drug use is a clinically meaningful target for treatment development, but few studies have evaluated the positive impacts produced by this behavioral change, preventing adoption of this endpoint in clinical trials. The proposed research will fill that critical knowledge gap by demonstrating the biopsychosocial benefits of reduced cocaine use. These data will be used to change current accepted cocaine treatment endpoints and accelerate identification of therapies for cocaine use disorder.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Self-report of recent cocaine use verified by a cocaine-positive urine sample
* Meet moderate-severe Cocaine Use Disorder Criteria
* Seeking treatment for their cocaine use
* Able to commit to 12-week intervention, plus 24-week follow up

Exclusion Criteria:

* History of serious physical or psychiatric disease (e.g., physical dependence on any drug requiring medically managed detoxification, unstable angina, uncontrolled cardiac arrhythmia, aortic stenosis, self-reported compromised immune function, extreme hypersensitivity/allergy to candida yeast or similar products, severe diagnosis for other substance use disorder) that would interfere with study participation
* Current physical or psychiatric disease that would interfere with study participation
* Poor veinous access, precluding blood draws
Combination With Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients

Children tend to anxiety and even fear before survey. And this kind of anxiety will not result in the forced induction of anesthesia, but also may increase the incidence of postoperative agitation in children, even lead to postoperative behavior changes.Currently,Oral midazolam or intranasal dexmedetomidine alone is commonly used as a preoperative regimen, but the clinical effects of each single-use are not satisfactory. In the investigators' study，the researchers conducted the current study to investigate whether dexmedetomidine combined with midazolam can increase the rate of satisfactory anesthesia induction in pediatric patients and achieve better sedative effect.

A trained member of the research team obtained a baseline The Modified Yale Preoperative Anxiety Scale(mYPAS) after obtaining consent. And corresponding study medication is administered about 30-40 minutes before the anesthesia induction.Vital signs were measured every 5 min after study medication administration.The sedation scores of the children were recorded with University of Michigan Sedation Scale (UMSS) every 10 minutes.The onset time of satisfactory sedation and parental separation anxiety scale was noted.Then recorded the degree of cooperation during inhalation anesthesia induction and recovery times.Moreover, recorded the pediatric anesthesia emergence delirium scale (PAED) during the recovery period.

Eligibility Criteria:
Inclusion Criteria:

1. with American Society of Anesthesiologists (ASA) physical status I or II；
2. aged 2-6 years；
3. children with weight for age within the normal range
4. were scheduled lower abdominal and perineal surgery with an expected operation time shorter than 30 minutes.

Exclusion Criteria:

1. Children who had gastrointestinal,Cardiovascular or endocrine dysfunction;
2. contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to either dexmedetomidine or midazolam;
3. with any nasal pathology,organ dysfunction;
4. recently respiratory infection, mental disorder;
5. other reasons that researchers hold it is not appropriate to participate in this trial.
Effects of Extra Corporeal Circuit Prime on Electrolytes Balance and Clinical Outcome Following Cardiac Surgery

About 6000 heart operations are performed in Sweden every year. A heart-lung machine is used almost exclusively in all heart operations. This machine fills the role of heart and lungs during surgery while the heart is stopped. The extra corporeal circuit (ECC) prime results in hemodilution, as assessed from the decrease in haematocrit, electrolyte concentration and total protein content. This hemodilution is an unavoidable consequence of the use of a heart-lung machine with nonblood ECC prime. The alteration of the patient´s blood volume and electrolytes is affected by the prime solution and can be maintained within normal limits. There are no clear recommendation regarding prime components and numerous prime solutions are in use worldwide.

The aim of this study is to investigate whether the use of mannitol in heart-lung machine prime has an effect on electrolytes levels and osmolality when compared with patients who receive no Mannitol.


Eligibility Criteria:
Inclusion Criteria:

* adult patients of both sexes who will undergo elective isolated coronary artery bypass grafting at the Department of Cardiothoracic Surgery, Skåne University Hospital, Lund

Exclusion Criteria:

* heart failure with left ventricular ejection fraction below 50%
* small size (defined as bodyweight less than 50 kg)
* anaemia with haematocrit less than 24%
* patients with previous cardiac surgery
* patients who receive other fluids or more than 1000 ml additional Ringers's Acetate during cardiopulmonary bypass
* patients with peroperative complications including massive peroperative fluid transfusions
Is Tuberculin Skin Testing Effective in Screening for Latent Tuberculosis (TB) in Elderly Residents of Nursing Homes?

In face of the increased rates of tuberculosis in residents of long term care facilities, annual screening for latent tuberculosis is recommended. Tuberculin skin testing using purified protein derivative (PPD) is used for this purpose. Sensitivity of the PPD testing is, however, dependent on a normal T cell function. It is now evident that the immune system undergoes age-associated alteration known as immune senescence. The depressed T-cell responses may clinically manifest as attenuated delayed-type hypersensitivity. This attenuated reaction may affect the sensitivity of the PPD in detection of latent TB in the elderly.

This prospective study will examine the utility of interferon-gamma (IFN-γ) based assay, T-SPOT.TB, for detection of latent tuberculosis in nursing home patients who are 65 years of age or older.


Eligibility Criteria:
Inclusion Criteria:

* 65 years of age and older
* No ulcerating or blistering skin disorder
* No previous history of adverse reaction to PPD testing
* No blood transfusion within 6 weeks prior to enrollment
* If the participant had a PPD placed and read by a public health department representative within the last 6 months, repeat PPD will not be done, but the person may participate in the study
* Participant may have been Bacille de Calmette et Guerin (BCG)-vaccinated

Exclusion Criteria:

* Less than 65 years
* Not a resident of a long term care facility
* Diagnosis of Tuberculosis
* blood transfusion within 6 weeks of enrollment
* Prior diagnosis of immune deficiency
Treatment Patterns and Key Healthcare Resource Use in Acute Myeloid Leukemia (AML) With or Without FMS-like Tyrosine Kinase-3 (FLT3) Mutation Study Based on Retrospective Chart Review

The purpose of this study is to retrospectively evaluate the treatment patterns and AML-related key healthcare resource use among AML patients, stratified by FLT3 mutation status, intensive chemotherapy (IC) eligibility, and relapsed or refractory (R/R) status.

The current study is a retrospective non-interventional study using real-world data collected from existing medical records to evaluate descriptively the treatment patterns and key healthcare resource use among AML patients with or without FLT3 mutation. The current study relies on secondary use of existing data, and there is no intervention involved. Patients who received the first AML treatment after the initial diagnosis, or were classified as relapsed/refractory (R/R), between January 1, 2013 and December 31, 2015 will be randomly selected to be included in this study, and the data from their existing medical records will be extracted. Eligible patients will be grouped based on FLT3 mutation status, intensive chemotherapy (IC) eligibility, and R/R status.

For newly diagnosed patients, the index date will be defined as the initiation date of the first AML treatment following initial diagnosis. For the R/R patients, the index date will be defined as the date of the patient being classified as R/R. The study period will be the period from the index date to last follow-up date or death, whichever comes earlier. The endpoint measurements of this study are treatment patterns and key AML-related healthcare resources used during the study period.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of AML but NOT acute promyelocytic leukemia (APL)
* Known FLT3 mutation status
* Under the care of the participating physician during the past 3 years OR from the initial diagnosis of AML
* The medical records related to AML for the patient are available to the physician and can be abstracted for this study
* The medical records contains complete information on treatments and AML-related hospitalization, including admission date, length of stay, and reason of hospitalization
* Initiation date of first treatment after AML diagnosis OR date of being classified as relapsed from or being refractory to initial treatment (R/R) is between January 1, 2013 and December 31, 2015

Exclusion Criteria:

* Not applicable