cyrilzakka/clinical-trials huggingface dataset:
Cerebral and Renal Oximetry Study in Preterm Patients Who Require Surfactant Administration

Respiratory distress syndrome of prematurity (RDSP) is an acute respiratory condition that occurs in preterm infants due to pulmonary surfactant deficiency.

Exogenous surfactant administration is a crucial therapeutic measure in the management of RDSP, being the 'less invasive surfactant administration technique' (LISA) the gold standard, according to the latest reviews.

Oximetry based on near-infrared spectroscopy is a non-invasive monitoring modality that provides continuous information on the degree of regional hemoglobin saturation present in the underlying tissue, mainly in the venous compartment. It is thus, a reflection of the balance between oxygen supply and demand of oxygen to the tissues.

We intend to perform a prospective analysis of newborns under 32 weeks of gestational age who require surfactant administration, as we wish to study cerebral and renal perfusion by oximetry in the group of patients who receive surfactant by LISA and in the group of patients who receive surfactant via endotracheal tube (patients intubated at birth for stabilization), since there are few data published in the literature.

Our main hypothesis is that the administration of surfactant by LISA technique does not negatively influence cerebral and renal oximetry.

Our secondary hypothesis is that patients requiring intubation at birth will present greater hemodynamic and respiratory instability in the first 72 hours of life, with a greater decrease in cerebral and renal oximetry with the administration of surfactant, compared to the group that does not require intubation at birth.


Eligibility Criteria:
Inclusion Criteria:

* preterm infants less than 32 weeks gestational age requiring surfactant administration

Exclusion Criteria:

* major congenital malformations
* chromosomopathies
Study Evaluating Single Doses of BLI-489 in Healthy Japanese Male Subjects

The purpose of this study is to evaluate the safety and tolerability of single doses of BLI-489 administered intravenously in healthy Japanese male subjects, and how the drug is absorbed and eliminated.


Eligibility Criteria:
Inclusion Criteria:

1. Men, aged 20 to 50 years of age inclusive at screening.
2. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 kg.
3. Healthy as determined by the investigator on the basis of the screening evaluations.
4. Nonsmoker of smoker of fewer than 10 cigarettes per day as determined by history.

Exclusion Criteria:

1. Presence of history of any disorder that may prevent the successful completion of the study.
2. History of drug abuse within 1 year.
Impact of Perioperative Physical Activity on Postoperative Pulmonary Complications and Quality of Life Among Esophageal Cancer Patients

This prospective cohort study examines the impact of perioperative physical activity on postoperative pulmonary complications among esophageal cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are diagnosed with esophageal cancer and scheduled to receive curative esophagectomy
* Patients who are able to read and understand the questionnaire
* Patients who are able to communicate with research personnel
* Patients who recognize the purpose of this study and provide written informed consent
* Patients without treatment for psychiatric disease

Exclusion Criteria:

* Patients who have difficulty for walking
* Patients with history of other cancer in the last 3 years
* Patients with neoadjuvant chemotherapy and/or radiation therapy
* Patients with recurrent esophageal cancer
* Patients with multiple cancer
* Foreigner or overseas patients who were not able to regularly participate this study
Dietary Choice for the Management of Cow's Milk Allergy Influences Other Allergic Manifestations

Food allergy is a common chronic condition in childhood. Recent studies have suggested that the natural history of food allergy has changed during the last two decades, with an increased prevalence, severity of clinical manifestations, and risk of persistence into later ages. The increased food allergy prevalence in children has an important economic impact, with significant direct costs for the healthcare system and even larger costs for the families of food-allergic patients. In addition, children with food allergies are at increased risk to develop other allergic manifestations later in life. According to a recent study, children with a food allergy are 2 to 4 times more likely to develop other atopic manifestations such as asthma (4.0 times), atopic eczema (2.4 times), and respiratory allergies (3.6 times), compared to children without a food allergy. Cow's milk allergy is among the most common food allergy in early childhood, with an estimated prevalence of 2% to 3%. It has been previously showed that in children with cow milk allergy, an extensively hydrolysed casein formula supplemented with the probiotic Lactobacillus rhamnosus GG induced higher tolerance rates compared to extensively hydrolysed casein formula without Lactobacillus rhamnosus GG and other formulas. These findings were consistent with those of a 1-year follow-up study performed in the US that showed better outcomes using an extensively hydrolysed casein formula+Lactobacillus rhamnosus GG vs. an extensively hydrolysed casein formula or amino acid-based formula for the first-line dietary management of cow milk allergy. In addition it has been recently demonstrated that extensively hydrolysed casein formula + Lactobacillus rhamnosus GG reduces the incidence of other atopic manifestations and hastens the development of oral tolerance in children with IgE-mediated cow milk allergy.

The present randomized controlled trial (RCT) was designed to test whether different dietary interventions could influence the occurrence of other atopic manifestations in children with IgE-mediated cow milk allergy.


Eligibility Criteria:
Inclusion Criteria:

* age 1-12 months
* IgE-mediated CMA

Exclusion Criteria:

* cow's milk protein-induced anaphylaxis,
* food protein induced enterocolitis syndrome,
* other food allergies,
* other allergic diseases,
* non-CMA-related atopic eczema,
* eosinophilic disorders of the gastrointestinal tract,
* chronic systemic diseases,
* congenital cardiac defects,
* active tuberculosis,
* autoimmune diseases,
* immunodeficiency,
* chronic inflammatory bowel diseases,
* celiac disease,
* cystic fibrosis,
* metabolic diseases,
* malignancy,
* chronic pulmonary diseases,
* malformations of the gastrointestinal and/or respiratory tract,
* administration of prebiotics or probiotics during the 4 weeks before enrolment.
Dapagliflozin in STEMI

The goal of this clinical trial is to assess the safety and efficacy of SGLT2i in limiting infarct size in patients with STEMI referred for PPCI.

Eligible STEMI patients enrolled into the trial will be randomized to a SGLT2i or placebo.

Cardiovascular Magnetic Resonance (CMR) imaging will be used to determine the infarct size.

DAPA STEMI is a single center, randomized, double-blind, parallel group study in which eligible participants with a STEMI and undergoing PPCI will be recruited and randomly assigned to dapagliflozin or placebo to take for 7 days. Participants will be prescribed study treatment i.e. dapagliflozin (10 mg) or placebo daily for 7 days.

A CMR will be obtained at day 3-5 to assess for infarct size. Participants will have follow-up visits at 30, 90, and 180 days to assess for cardiovascular events.

Eligibility Criteria:
Inclusion Criteria:

Patients referred for PPCI meeting the following criteria are eligible for the study:

* Ischemic chest discomfort of ≥30 minutes duration, and
* Onset of chest pain ≤12 hours prior to entry into the study, and
* One of the following High-Risk criteria on a standard 12 lead ECG:

  a. Anterior STEMI with ST-segment elevation ≥2mm (0.2 mV) in each of at least 2 contiguous precordial leads (V1-V6) b. Extensive non-anterior STEMI defined as ST-segment elevation of \>1mm in two or more contiguous non-anterior leads accompanied by i. 8 or more leads with \> 1 mm ST elevation or depression, or both; OR ii. Sum of ST- segment elevation \>20mm

Exclusion Criteria:

* Age \< 18 years
* Any contraindication to undergo CMR imaging
* Killip 4 (Cardiogenic shock on presentation)
* Therapy with SGLT2i within last 8 weeks
* Type 1 diabetes mellitus
* Pregnancy
* Nursing mother
* Unwilling to use appropriate forms of contraception, as applicable
* Chronic symptomatic HF with prior hospitalization for HF within the last year
* hospitalization
* Known history of prior MI
* Any non-CV condition with a life expectancy of less than one year
* Previous randomization in the present study
* Participation in a study with another investigational device or drug \< four weeks
* Inability to provide informed consent
* Confirmed ketoacidosis at time of admission
* Known severe hepatic impairment (Cirrhosis)
* Severe renal impairment (eGFR \< 30 mL/min1.73m2 (based on prior or baseline blood work)
* Known severe valvular heart disease
* Need for CABG within 90 days based on the results of the initial coronary angiogram
* False positive STEMI (based on the results of the coronary angiogram)
Nutritional and Anti-infective Interventions for Malnutrition in Pregnancy (Beleuman Welbodi)

Acute malnutrition in pregnancy is a risk factor for adverse outcomes in mothers and their unborn children. Undernutrition during pregnancy can result in maternal complications such as life-threatening hemorrhage and hypertensive disorders of pregnancy and infant complications such as intrauterine growth retardation, low birth weight, pre-term delivery and poor cognitive development. Poor women in the developing world are at heightened risk of malnutrition due to inadequate dietary intake and are subject to transmission of a number of infections including malaria, intestinal helminths, and genitourinary infections. Food interventions for malnutrition may be less effective under conditions with excessive inflammation and infection, and especially so during pregnancy. Without specifically addressing treatment for infections, undernourished mothers may be less responsive to nutritional interventions. The benefits of treating both malnutrition and common infections simultaneously remain largely unstudied. This study tests the hypothesis that malnourished pregnant women receiving 100 grams per day of a specially formulated ready-to-use supplementary food in addition to a combination of 5 anti-infective interventions will have greater weight gain in pregnancy and deliver larger, longer infants than women receiving the standard of care. The outcome of the pregnancy and maternal nutritional status will be followed until 6 months after delivery.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women and consenting to study participation
* Fundal height not greater than 32 cm
* Mid-upper arm circumference ≤23 cm
* Planning to reside in the study area during pregnancy and 6 months post partum
* Attending 1 of the 40 antenatal clinic sites

Exclusion Criteria:

* \< 16 years of age without adult willing to consent
* Known pregnancy complications such as gestational diabetes, pre-eclampsia, hypertension
The Use of Virtual Reality for the Treatment of Visual Vertigo.

This study investigates the use of virtual environments presented on a head mounted display for the rehabilitation of those suffering with visual vertigo.

The control group and treatment groups will be presented with two different sets of environments and be given the same head and eye exercises to complete within the environment. They will also be provided with at home exercises to complete.

Visual vertigo occurs after the balance system suffers damage (e.g after a viral infection such as labyrinthitis). This causes an over-reliance on the eyes to maintain balance which causes disorientation in busy environments such as the supermarket. The treatment involves trying to desensitise the individual to visually stimulating situations. Further head and eye exercises are completed alongside the exposure to overcome the damage done to the balance system.

Eligibility Criteria:
Inclusion Criteria:

* Those who have been diagnosed with visual vertigo and have scored a significant level on the Situational Characteristic Questionnaire (over 0.74 as per Pavlou et al., 2006).

Exclusion Criteria:

* Those with or under investigation for epilepsy.
* Those who have been determined to have no or limited balance function in both ears.
* Those with reduced visual acuity that will leave them unable to view the 3D effects of the head mounted display.
* Those with severe mental health disorders e.g. psychosis, paranoid disorders, bipolar disorder or a history of substance abuse.
* Severe neck pain/ restricted movement.
* Previous treatment for visual vertigo.
* Those with an fluctuating vestibular disorder such as Ménière's disease or vestibular migraine.
* Those with untreated Benign Paroxymal Positional Vertigo (BPPV).
* Those with a significant brain injury, or head injury that results in a central vestibular disorder.
* Those with an arrhythmia.
Multi-omics Database Construction of Healthy Korean Volunteers

The goal of this prospective, observational study is to collect health-related data including microbiome, blood samples, and dietary habits from the oral and gastrointestinal tracts in healthy subjects. In addition, the study aims to perform microbiome and multi-omics analysis on the collected samples and build an integrated database of the data.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are at least 13 years old and no older than 85 years old at the time of giving their informed consent.
* Subjects who have received a comprehensive explanation of this study, fully understand it, and have voluntarily agreed to participate, providing signed and dated informed consent.
* Subjects considered eligible for participation in the study by the researcher, based on screening procedures including physical examination, clinical laboratory tests, and questionnaires.

Exclusion Criteria:

* Subjects with a Body Mass Index (BMI) below 17.0 or above 30.0.
* Vital signs at rest showing a systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg, along with symptoms related to high blood pressure such as headaches.
* History of using specified drugs within a predetermined period before microbiome collection, as detailed in the Appendix.
* Receipt of any vaccination within the last 4 weeks prior to microbiome collection.
* Use of topical antibiotics or steroids on the face, scalp, neck, arms, forearms, or hands within 24 hours before microbiome collection.
* Application of vaginal or vulvar medications, including antifungals, within 24 hours of microbiome collection.
* Presence of an acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Sampling can be deferred until the subject recovers.
* History of chronic, clinically significant disorders affecting the hepatic, digestive, circulatory, renal, neurological, respiratory, endocrine, immune, or hematological systems, as well as malignant tumors, psychiatric conditions, or substance abuse.
* Substantial dietary alterations for rapid weight gain or loss within 4 weeks of the microbiome collection.
* Positive serological tests (HBs antigen, HCV antibody, and HIV antibody tests) or results above the reference range.
* History of gastrointestinal surgery, excluding simple procedures like appendectomy, cholecystectomy, or hernia repair.
* Presence of gastrointestinal conditions that may influence microbiome analysis and are not under medical control, including Inflammatory Bowel Disease (IBD) including Crohn's disease and ulcerative colitis, Irritable Bowel Syndrome (IBS) requiring medication, ulcers, acute or chronic pancreatitis, and chronic constipation requiring medication.
* Diagnosis of ankylosing spondylitis.
* Requirement for the regular use of incontinence diapers.
* Positive pregnancy test, or being pregnant or lactating.
* Any medical condition suspected at the time of microbiome collection that may affect the integrity of the sample.
Cardiac Rehabilitation and Frailty Physical Training Program in Elderly Patients After Open Heart Surgery

The aim of the research - to evaluate the impact of interactive physical therapy tools for functional capacity, fear of falls, motivation and quality of life after open heart surgery due to ischemic heart disease and frailty in the second stage of rehabilitation.

The clinical trial will be performed during patient rehabilitation. All examination of the patient will be performed before rehabilitation and at the end of rehabilitation. Total subjects will spend 20 days in rehabilitation. All subjects who will have frailty syndrome will be assigned to one of three groups: control, intervention group-1 or intervention group-2.

Eligibility Criteria:
Inclusion Criteria:

* Patient's agreement to participate in the study,
* Age 65 years and older,
* Patients admitted to CR after open heart surgery,
* Patients with frailty (Edmonton frailty scale ≥4)
* 6-minute walk distance (6-MWD) ≥150 meters and walking without mobility aid.

Exclusion Criteria:

* Patient's disagreement to participate in the study
* Exercise-limiting comorbidities (primarily orthopedic and neurological conditions that would exclude individuals from participating in cardiac rehabilitation according to study protocol), cognitive, vision, linguistic deficits, chronic heart failure Class IV, anemia, wound healing disturbance or other various acute conditions that may limit active participation in physical therapy programs.
Identification of Novel Inflammation-related Biomarkers for Early Detection of Anthracycline-induced Cardiotoxicity in Breast Cancer Patients

This study aims to identify possible set of inflammatory biomarkers before, during and after anthracycline-based chemotherapy in breast cancer patients to identify (sub)clinical chemotherapy-related cardiac dysfunctionCRCD to identify patients who would benefit from additional cardioprotective therapy.


Eligibility Criteria:
Inclusion Criteria:

* initial diagnosis of breast cancer
* planned Anthracycline-based therapy
* first-line chemotherapy
* first visit before initiation of chemotherapy

Exclusion Criteria:

* previous chemotherapy
* medical history of cardiac disease
* inflammation-modulating medication
* medication with RAS inhibitors
* pregnancy
* autoimmune disease
* drug addictions
* unwilling or unable to provide informed consent
Study of Genes in Relation to Seasonal Affective Disorder and Major Depressive Disorder

The investigators are looking for volunteers who have a history of Major Depressive Disorder, the Winter Blues, or Seasonal Affective Disorder or healthy volunteers who do not have a history of these disorders for a research study on genetics.

The investigators are looking for volunteers who have a history of Major Depressive Disorder, the Winter Blues, or Seasonal Affective Disorder or healthy volunteers who do not have a history of these disorders for a research study on genetics. Participation involves one 2-3 hour visit involving two diagnostic interviews, DNA collection, and questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* SAD or MDD
* healthy control

Exclusion Criteria:

* drug or alcohol dependence
* Bipolar Disorder
A Pilot Trial of the Reach Out, Stay Strong, Essentials for Mothers of Newborns (ROSE) Postpartum Depression Prevention Intervention in Pregnant Patients Admitted to Strong Hospital

This study is a pilot, single-center, randomized controlled trial. It will

1. determine feasibility and acceptability of an evidence-based intervention for prevention of postpartum depression with antepartum patients on a high-risk obstetric unit,
2. determine what adaptations may be needed for an inpatient population
3. determine what retention strategies are most successful and acceptable for this patient population
4. estimate the effect size of an intervention for in-hospital distress, anxiety and depression
5. estimate the effect size of an intervention to reduce the risk of a post-partum depression diagnosis or depressive symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Viable pregnancy between 20 weeks 0 days and 35 weeks 0 days gestation at the time of enrollment
* Anticipated admission to the hospital for \>5 days due to pregnancy complication requiring hospital observation
* Age \> 18 years
* Planned hospitalization at Strong Memorial Hospital through the duration of antepartum course
* Planned delivery at Strong Memorial Hospital

Exclusion Criteria:

* Fetal demise in utero
* Inability to give informed consent secondary to intellectual capacity
* English is not primary language used to communicate
* Currently incarcerated
* Age \< 18 years
* Planned antepartum hospitalization at another institution
* Planned delivery at another institution
* Actively suicidal or in need of acute psychiatric care
CRISPR-Edited Allogeneic Anti-CLL-1 CAR-T Cell Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia

CB-012 is an allogeneic chimeric antigen receptor (CAR-T) cell therapy that targets C-type lectin-like molecule-1 (CLL-1). This is a Phase 1 study to evaluate the safety, preliminary efficacy, and pharmacokinetics, of CB-012 (the study treatment) in adults with acute myeloid leukemia (AML) that has come back after prior treatment (relapsed) or did not respond or is no longer responding to other treatment (refractory). Participants must have received at least 1 but not more than 3 prior lines of treatment for AML .


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of AML with either refractory or relapsed disease,
* Non-proliferative disease
* No more than 3 prior lines of therapy (induction, consolidation with or without allogeneic stem cell transplant, and maintenance are considered 1 line of therapy)
* No available therapy with reasonable survival benefit
* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 and fit for allogeneic stem cell transplant
* Adequate renal, hepatic, pulmonary, and cardiac function, with specific laboratory criteria
* Women of child-bearing potential and men with a female partner who has child-bearing potential must agree to use acceptable, effective methods of birth control.

Exclusion Criteria:

* Acute promyelocytic leukemia
* Extra-medullary disease (EMD) that is metabolically inactive by 18-FDG PET-CT
* Prior treatment with CAR-T cell therapy
* Allogeneic stem cell transplant within 100 days before lymphodepletion
* Active graft-vs-host disease requiring therapy
* Known active or prior history of central nervous system involvement
* Seropositive for or history of human immunodeficiency virus (HIV)
* Vaccinated with live, attenuated vaccine within 4 weeks prior to lymphodepletion
* Active hepatitis B or C infection
* Primary immunodeficiency or autoimmune disease
* Known life-threatening allergies, hypersensitivity, or intolerance to CB-012 or its excipients

Other inclusion and exclusion criteria may apply.