cyrilzakka/clinical-trials huggingface dataset:
Comparison of High Flow Nasal Cannula and Standard Face Mask Oxygen Therapy in Children With Bronchiolitis

The study aims to compare the efficacy of two different oxygenation methods on decrease respiratory rate, heart rate, and clinical respiratory score in children with moderate to severe bronchiolitis requiring oxygen therapy.

1. Standard face mask oxygen therapy (St-FMOT)
2. High-flow nasal cannula oxygen therapy (HFNCOT)

Bronchiolitis is the most common cause of hospitalization for children under one year of age and, caused by respiratory viruses. Although several medications and interventions studied for bronchiolitis treatment, hydration and oxygenation are the main treatments. High-flow nasal cannula oxygen therapy (HFNCOT) has been widely used to provide respiratory support in children with acute respiratory diseases.

Patients had earlier improvement with HFNCOT to decrease the respiratory rate and respiratory effort than patients with standard low-flow oxygen therapy (SOT).

HFNCOT therapy reduced more effective in heart rate, respiratory effort, and length of supportive oxygen treatment (LOOT) compared with SOT. However, the length of hospital stay (LOS) and feeding ability had better consequences in patients with moderate and severe bronchiolitis treated with HFNCOT.

Another published study shows that in infants with acute bronchiolitis, which required oxygen therapy, there was no significant difference between therapy groups in terms of LOOT, LOS, and admission to the intensive care unit (ICU). HFNCOT was more efficient than SOT and reduced the rate of intubation/invasive ventilation in severe bronchiolitis management. Despite these beneficial effects of HFNCOT, it was not recommended by international guidelines yet. However, well designed, prospective randomized controlled trials are still needed to use this therapy in the wards.

Eligibility Criteria:
Inclusion Criteria:

* Children aged between 1-24 months applied with moderate and severe bronchiolitis requiring supplemental oxygen were eligible for the study.
* The severity of bronchiolitis was assessed according to the clinical respiratory score (CRS) of Liu et al. (5). The patients with CRS ≥5 were included.
* Peripheral oxyhemoglobin saturation is \< 92%.

Exclusion criteria:

* Children admitted to the ICU for urgent invasive mechanical ventilation;
* those who received standard oxygen therapy (SOT) or HFNCOT at other facilities before arrival;
* those with an underlying medical condition (such as congenital heart disease, chronic lung disease, neuromuscular disease, metabolic disease, or immunocompromised);
* those who had a craniofacial malformation, an upper airway obstruction, pneumothorax, or nasal trauma, and missing parental consent or a refused permission of the participant.
Study Based on Electronic Health RecOrds to Identify Patients at High-risk of Fabry DiseasE (HOPE Fabry)

Primary objective:

To estimate the prevalence of patients who are at high-risk for Fabry Disease (FD) in the Cleveland Clinic, Abu Dhabi (CCAD) United Arab Emirates (EMR) database from May 2016 to May 2022, according to the predictive algorithm (i.e., feasibility assessment eligibility criteria)

Secondary objectives:

* To estimate the prevalence of FD among patients at high-risk for FD (i.e., among enrolled patients)
* To characterize the patient profile, overall and in Cohorts 1 and 2
* To describe the most common characteristics among positive FD patients and negative FD patients

Patients at high-risk for FD will be consecutively enrolled over approximately 6 months

Eligibility Criteria:
Inclusion Criteria:

* Patients who were identified as high-risk for FD via the predictive algorithm per the feasibility assessment
* Patients who have signed an informed consent form

Cohort 1 (chronic kidney disease)

* Adult male patient ≤60 years old or adult female patient of any age
* Having chronic kidney disease
* Having proteinuria
* Having one or more of the following conditions:

  * Neuralgia and neuritis, unspecified
  * Disturbances in skin sensation
  * Anhidrosis, and
  * Hypertrophic cardiomyopathy.

Cohort 2 (hypertrophic cardiomyopathy)

* Adult male patient ≤50 years old or adult female patient of any age
* Having hypertrophic cardiomyopathy
* Having one or more of the following conditions:

  * transient cerebral ischemic attack,
  * chronic kidney disease.

Exclusion Criteria:

* Patients with an established diagnosis of FD.
* Pregnant subject at the time of the study.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Validation of a Nutrition Screening Tool

The objective of this study is to evaluate the sensitivity and specificity of two nutrition screening tools to identify inpatients with malnutrition or at risk of malnutrition. The two tools are the Royal Marsden Abridged Adult Nutrition Screening Tool (AANST) and the Malnutrition Screening Tool (MST)\[10\] The tools will be compared with the currently accepted gold standard, Patient Generated Subjective Global Assessment (PG-SGA). Both screening tools are in the form of scored questionnaires and are suitable for electronic input.

The ultimate objective is to select an adult inpatient nutrition screening tool with the highest sensitivity for future use in the oncology inpatient setting in order to allow prompt commencement of an appropriate nutrition care plan.


Eligibility Criteria:
Inclusion Criteria:

* All adult inpatients, over the age of 18, admitted to RMH for whom a measured weight and height can be obtained

Exclusion Criteria

* Patients for whom it is not possible to obtain a measured height and weight
* People with a definitive diagnosis of dementia
* People who lack capacity to understand the purpose of the study and to consent
* Patients who are unable to understand and speak English
Predictors of Acute Kidney Injury in Critically Ill Children Admitted to PICU.

Predictors of Acute Kidney Injury in critically ill children admitted to PICU during one year.

Acute kidney injury (AKI) is defined by a sudden loss of excretory kidney function. AKI is part of a range of conditions summarized as acute kidney diseases and disorders (AKD), in which slow deterioration of kidney function or persistent kidney dysfunction is associated with an irreversible loss of kidney cells and nephrons, which can lead to chronic kidney disease (CKD).

AKI is determined by increased serum creatinine levels \>0.3 mg/dl (a marker of kidney excretory function) and reduced urinary output \<0.5 ml/Kg for more than 8 h (a quantitative marker of urine production) and is limited to a duration of 7 days and when lasts for \>3 months is referred to as chronic kidney disease (CKD). Acute kidney injury (AKI) is associated with poor outcome in critically ill children. The reported incidence rate of AKI in children admitted to pediatric intensive care units (PICUs) ranges from 8% and 89% worldwide. Stage 1 was identified in 24.24% of the AKI cases, stage 2 in 31.03% and stage 3 in 44.71%. The most prevalent cause of AKI was represented by prerenal AKI in 85.64% of the cases, followed by 12.16% renal causes respectively 2.18% postrenal causes. Symptoms of an AKI come on suddenly, over the course of hours or days. They depend on the underlying cause, but some of the most common symptoms include hematuria, fever, rash, bloody diarrhea, severe vomiting, abdominal pain, no urine output or high urine output, pale skin. oedema, puffy eyes and detectable abdominal mass. There are many predisposing factors that lead to AKI for such as gastroenteritis, presence of infection, sepsis, shock, cardiac disease, mechanical ventilation hypoxia and coagulopathy are important predictors for AKI.

Despite significant developments in the management of AKI, the overall mortality rate of patients with AKI has not improved dramatically. The most widely available studies deal primarily with AKI, reporting mortality rates between 11% and 63% in pediatric patients.

Outcomes among children who develop acute kidney injury (AKI). Children who develop AKI while hospitalized are at risk for poorer short- and mid/long-term outcomes. Across both acute and critical care populations, AKI is associated with longer lengths of stay, non-recovery of baseline renal function, and chronic renal disease including proteinuria, hypertension, and chronic kidney disease (CKD)

Eligibility Criteria:
Inclusion Criteria:

* children aged from month to 18 years admitted to PICU between April 2024 to May 2025.

Exclusion Criteria:

* Exclusion of children aged below 1 month and older than 18 years.
* chronic kidney disease.
* renal malformations.
Gene Polymorphisms and Gene Products as Biological Markers of Aging and Correlation With Clinical Geriatric Assessment, Tolerance of Chemotherapy and Outcome in Elderly Breast Cancer Patients

The goal is to study the biology of aging in breast cancer patients, and to study the impact of chemotherapy on aging related blood biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* 70 years or older
* Female
* Early breast cancer
* Candidate for systemic adjuvant therapy
Efficacy of Acupuncture for Prophylaxis of Intrathecal Morphine Induced Pruritis in Patients Undergoing Caesarean Delivery

Intrathecal morphine is commonly used for pain relief in caesarean delivery. Side effects such as itch (pruritis) and nausea \& vomiting are common and have been shown to be the most common cause for dissatisfaction. The incidence of pruritis is 74% even with current available medications. Acupuncture has been shown to be effective for morphine related side effects but has not been evaluated for prophylaxis of itch in pregnant population.

PRIMARY OBJECTIVE:

Acupuncture at LI 11 reduces the incidence of pruritis after elective caesarean section under spinal with intrathecal morphine


Eligibility Criteria:
Inclusion criteria:

* ASA I \& II patients undergoing elective caesarean delivery under spinal with intrathecal morphine

Exclusion criteria:

* Patient refusal
* ASA III \& IV patients
* Pre-existing pruritis
* Eczema
* Bleeding tendencies
* Known allergy to any of medications used
* Any contra indication to spinal anaesthesia
Internet-based Study of Fertility and Early Pregnancy (PEEPS)

The purpose of this study is to assess the feasibility of conducting an Internet-based prospective pregnancy study with preconception enrollment with women completing daily journals for up to 12 months while trying to conceive and weekly through pregnancy if it occurs.

There is a dearth of knowledge regarding the role that preconception health plays in fertility and early pregnancy loss. Classical methods of conducting prospective pregnancy studies with preconception enrollment to answer these questions are time-consuming in terms of recruitment efforts and expensive to carry out. The purpose of this project is to assess the feasibility of conducting an Internet-based prospective pregnancy study with preconception enrollment in the United States using the gold standard data collection approach of daily diaries during the trying to conceive period. We will accomplish this by enrolling 200 females of reproductive age who attempting to conceive and following them for up to 12 months and through pregnancy for those who become pregnant. Feasibility will be assessed by measuring: the number of women who screen eligible, the number of women who enroll, and compliance with journal use over time. We will also estimate the incidence of infertility, pregnancy and pregnancy loss as well as compare the demographics of women who enroll to the demographics of women who participate in community-based prospective pregnancy studies with preconception enrollment. The data from this project will be used to assess the feasibility of launching a larger prospective pregnancy study that is appropriately powered to examine the impact of preconceptional lifestyle factors on the incidence of infertility and early pregnancy loss.

Eligibility Criteria:
Inclusion Criteria:

* Women
* Ages 18-44
* In a stable relationship
* Sexually active with a male partner
* Reliable daily access to the Internet

Exclusion Criteria:

* Woman or her partner has a known fertility problem
* Trying to conceive for three or more months.
The Healthy Eating Choices for Life Program

The purpose of this investigation is to conduct a 12-week pilot study to examine the effect of three different dietary prescriptions that differ on targeting reducing energy density (kcal/gram) and energy (kcal) on overall dietary intake, hunger, feelings of deprivation, satisfaction with the diet, mood, and weight loss in 45 overweight/obese adults receiving a 12-week behavioral weight loss intervention.

Given the current prevalence of overweight and obesity among adults in the United States and the projected increase of these conditions in the future, development of effective weight loss and weight loss maintenance strategies is imperative. For weight loss to occur, energy intake needs to be reduced to incur an energy deficit, and for successful weight loss maintenance, energy intake needs to remain lower than energy intake at pre-weight loss levels due to an overall reduction in body size which reduces basal metabolic rate. One dietary strategy that may facilitate weight loss maintenance is consuming a diet low in dietary energy density (ED). This pilot study will test the effects of a dietary prescription focused on ED.

All participants in the investigation will receive a standard 12-week behavioral obesity intervention. The intervention will include an activity goal that participants will gradually work to achieve over the course of the 12-week intervention along with standard behavioral weight loss strategies. One condition will receive a dietary prescription for weight loss that focuses solely on lowering the ED of the diet, another condition will receive the traditional dietary prescription used in behavioral weight loss interventions that reduces energy intake, and the third condition will receive both prescriptions. Pre and post intervention measurements will be taken to determine if there are differences between groups.

Eligibility Criteria:
Inclusion Criteria:

* Age between 21 and 65 years
* Body mass index (BMI) between 25 and 45 kg/m2

Exclusion Criteria:

* Report a health condition on the Physical Activity Readiness Questionnaire (PAR-Q)
* Report being unable to walk for 2 blocks (1/4 mile) without stopping
* Report major psychiatric diseases/organic brain syndromes via a phone screen
* Are currently participating in a weight loss program and/or taking weight loss medication or lost \> 5% of body weight during the past 6 months
* Intend to move to another city within the time frame of the investigation
* Are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation
* Have had gastric surgery for weight loss
Wellness Monitoring for Major Depressive Disorder

The Wellness Monitoring for Major Depressive Disorder (MDD) study is a prospective, longitudinal, observational study aimed at identifying biomarkers of relapse in MDD. Results may help refine clinical approach to relapse management, and may ultimately help MDD patients sustain wellness while on antidepressant medication.

This study involves a naturalistic follow up of responders from the study entitled "Integrated biological markers for the prediction of treatment response in depression", or the CAN-BIND-1 study. In addition, this study is also open to other participants who completed other CAN-BIND studies, as well as remitters who meet the inclusion criteria. Since patients usually seek medical attention only after relapse has occurred, imminent precursors to relapse are not well known. In this study, participants who are currently responding to an oral antidepressant treatment regimen and/or therapeutic intervention will be monitored over a minimum period of 13 months, which provides a unique opportunity to discover near-term biomarkers of relapse.

The study is conducted in partnership with Janssen Research \& Development and utilizes remote monitoring technology for data gathering.

Eligibility Criteria:
Inclusion Criteria:

* Meet DSM-V criteria for Major Depressive Episode (MDE) in MDD as determined by MINI.
* MADRS total score of equal to or less than 14.
* In the current MDE, patient must currently be responding to an antidepressant medication or a combination of treatments for MDD.
* Willing and able to complete self-reported assessments via a study-specific smartphone (LogPad), including sufficient fluency in English.
* Willing to wear GT9X Link, a wrist-worn device for the duration of the study.

Exclusion Criteria:

* Axis I diagnosis, other than MDD, that is considered the primary diagnosis.
* Bipolar I or Bipolar II diagnosis (lifetime), MDD with psychotic features (lifetime), schizophrenia, or schizoaffective disorder.
* Presence of a significant Axis II diagnosis (borderline, antisocial).
* High suicidal risk, defined by clinician judgement.
* History of drug or alcohol use, with severity of at least moderate or severe, according to DSM criteria, within 6 months before screening.
* Presence of significant neurological disorders, head trauma, or other unstable medical conditions.
* Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before screening or is currently enrolled in an investigational study.
* Has a condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g. compromise well being) or that could prevent, limit, or confound the protocol-specified assessments.
* Subject is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, or is a family member of an employee or the investigator.
Triggers and Responses to Simulator Sickness in Videogame Players

The objective of this research is the accumulation of gameplay data and simulator sickness background surveys for trend analysis, and individual simulator sickness trigger factor analysis for the test subjects involved. Rather than isolating specific variables for hypothesis formulation, this study will be attempting to collect an array of data that is a) both qualitative and quantitative, and b) observational and test subject-reported. The final results will consist of a list of possible trigger factors to avoid for individual subjects, and metrics showing the directional tendencies of players depending on the severity of their symptoms at the time.

The overall goal of this research is to better understand factors that contribute to simulator sickness, both in who it affects and why some gameplay experiences may cause it more than others. Operating from the basic assumption that the way a player moves through an environment affects how quickly that player gets sick, we will primarily be gathering data on how the player moves through the digital space and whether that behavior changes once they begin to feel sick.


Eligibility Criteria:
Inclusion Criteria:

* Survey participants should have some experience with playing videogames or similar interactive simulations on 2D displays.
* At least one-half of research participants should have experienced simulator sickness at some point in recent memory (within the past year) in response to a simulated experience.

Exclusion Criteria:

* Players under 18 will be excluded from participating in the experimental portion of the project.
* manual dexterity deficit or inability to use the gameplay interface
* Non-English speakers
* Acute state of illness.
Compliance to Synagis (Palivizumab) Under Daily Pediatrician´s Conditions in Premature Infants 33 - 35 wGA

Compliance to Synagis (palivizumab) is a key factor to obtain maximal protection against respiratory syncytial virus (RSV) infection as shown in the IMpact study. Many factors such as parents' knowledge of burden of respiratory syncytial virus disease or physicians' satisfaction with Synagis as well as the appropriate use of the product might influence compliance. The primary objective of this observational study is to evaluate the compliance to Synagis under daily pediatricians practice conditions in premature infants 33 to 35 weeks gestational age (wGA). Palivizumab, monoclonal antibody for passive immunoprophylaxis against severe respiratory syncytial virus disease, was administered according to usual clinical practice. Compliance was assessed using four criteria: The number of injections per participant per respiratory syncytial virus season, the body site where injections were administered, the interval in days between injections, and the dosage per administration. Originally the study was to include two respiratory syncytial virus seasons but was extended to a third season.


Eligibility Criteria:
Inclusion Criteria:

* Premature infant 33 to 35 weeks gestational age
* Younger than 3 months at respiratory syncytial virus season start
* At least 4 points according to the Austrian risk score according to Austrian guidelines: 1 point younger than 3 months (at start of respiratory syncytial virus season), 1 point neurologic disease, 1 point weight less than 10th percentile, 1 point discharge from hospital during respiratory syncytial virus season (1 Oct - 30 March), 1 point older siblings, 0.5 points multiple births, 0.5 points day care attendance, 0.5 points passive tobacco smoke exposure, 0.5 points socio-economic status (overcrowding)
* Synagis application (prescription)
* Signed authorization form for data use (parental authorization)

Exclusion Criteria:

* Patients without Synagis prescription
* Patients who meet contraindications as outlined in the latest version of Synagis summary of product characteristics (SmPC):

  * Patients with known hypersensitivity to palivizumab or any component of the formulation or other humanized monoclonal antibodies
* Patients with chronic lung disease
* Patients with congenital heart disease
* Greater than 36 weeks gestational age
Optimizing Resilience and Coping in HIV Via Internet Delivery

This is a feasibility/pilot test of a set of positive affect skills provided online to HIV positive people with elevated depressive symptoms - a Center for Epidemiological Studies Depression Scale D (CES-D) score \> 10. The investigators will test the feasibility of recruitment, retention and acceptability of these skills in an online delivery format, determine feasibility and acceptability of daily emotion assessments via text messaging and assess efficacy of these skills for improving psychological well-being this population.


Eligibility Criteria:
Inclusion Criteria:

* HIV +
* 18 or older
* Score of CES-D depression scale \>10
* Daily internet access
* Smart phone ownership

Exclusion Criteria:

-
Treatment of Covid-19 Associated Pneumonia With Allogenic Pooled Olfactory Mucosa-derived Mesenchymal Stem Cells

Treatment of patients with Covid-19 associated pneumonia using intravenous injection of allogenic pooled olfactory mucosa-derived mesenchymal stem cells

During the implementation of the project, it is planned to develop a method for the treatment of severe covid-19 associated interstitial pneumonia using allogeneic mesenchymal stem cells. The positive outlook for the effectiveness of MSCs is due to the following:

* knowledge of the leading role of immunopathogenetic mechanisms in the development of acute interstitial lung diseases and the pronounced immunomodulating properties of MSCs;
* high tropism of MSCs to lung tissue when administered intravenously;
* the ability of MSCs to stimulate tissue regeneration and the effective use of MSCs in the treatment of acute damage to the myocardium and kidneys, which will contribute to the treatment of multiple organ failure;
* positive results of preclinical studies of the method of treatment of viral pneumonia in animals, and the first clinical studies in patients.

Eligibility Criteria:
Inclusion Criteria:

* PCR-confirmed Covid-19 pneumonia
* respiratory failure

Exclusion Criteria:

* diagnosed cancer