cyrilzakka/clinical-trials huggingface dataset:
Oropharyngeal Administration Of Colostrum For Preventing Necrotizing Enterocolitis in Preterrms

Mother's milk samples will be collected during the routine expression of milk, using a hospital-grade electric breast pump, and will be stored in the NICU breastmilk refrigerator. The research doctor will prepare the syringes for the first 24 hours of the Initial Treatment Period. For neonates in the placebo group, the milk is immediately frozen, in a separate NICU breastmilk freezer to maintain blinding, for later use when enteral feedings are started. Using sterile gloves, oral syringes will be each filled with 1 mL/kg of colostrum or normal saline 0.9% (based on group assignment), capped, and covered with a white tape as a blinding procedure. Each syringe will be labeled with the patient's name, medical record number, and the date and time of preparation. Syringes will be prepared in the same sterile manner, by the research doctor, every 24 hours.

Oropharyngeal administration procedure using a standardized protocol, the doctor will provide the dosing as follows: two syringes will be warmed to room temperature. The first syringe's cap is removed and the tip of the syringe is gently placed into the neonate's mouth, alongside the right buccal mucosal tissue. The syringe tip is directed posteriorly towards the oropharynx, and the total volume (0.5 mL/kg) is slowly administered, over 20 seconds. The second syringe will be placed in the neonate's mouth in the same manner, but alongside the left buccal mucosal tissue. The entire volume (0.5 mL/kg) is administered slowly, over 20 seconds. A petite swab is used to carefully swab the right buccal mucosal tissue, followed by the left buccal mucosal tissue (≤5 seconds each side). A total volume of 1 mL/kg is administered per treatment, with buccal swabbing taking place over 10 seconds. Vital signs are carefully monitored throughout the procedure. Dosing is provided every 3 hours during the period of study.

Sample size will be 34 in each group, .

* Group A: receiving oropharyngeal colostrum for 10 days.
* Group B: control group receiving placebo for 10 days.
* Group C: receiving oropharyngeal colostrum for 3 days.

Eligibility Criteria:
Inclusion Criteria:

* Neonates with gestational age (GA) ≤ 34 weeks at birth
* Neonates who will be in admitted in the neonatal intensive care unit (NICU) within 48 hours after birth.

Exclusion Criteria:

* Any contraindication for breastfeeding as mother-related (e.g. Mothers prohibited from breastfeeding because of conditions including active tuberculosis or AIDS, treatment with radioisotopes (e.g., Iodine-131, Cobalt-60, Cesium-137) and substance abuse)
* Also any contraindication for breastfeeding as infant-related (Birth complicated with severe gastrointestinal malformations).
Influence of Propofol on Alveolar Macrophage in Asthmatic Patients

The change of airway responsiveness and alveolar macrophage (AM) immunity occurs during the pathogenesis of asthma. Macrophage-associated airway protection in patients with asthma is affected positively or negatively by propofol general anesthesia. The investigators hypothesized that the effects of propofol on asthmatic AMs and corresponding airway reactivity in vivo is different from the in vitro research. Through in vivo airway hyperresponsiveness (AHR) observation and clinical investigation of AM immune functions from asthma patients undergoing propofol general anesthesia to clarify the precise effects of propofol on AM immunity, and to provide theoretical basis for the clinical administration of propofol in asthmatic patients. This would optimize the practice of clinical anesthesia, especially for those with the tendency of AHR.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II;
* Aged from 18 years to 45 years;
* Patients with or without asthma or a history record of asthma;
* Undergoing elective lumpectomy under general anesthesia.

Exclusion Criteria:

* Allergy to propofol and opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records;
* Participants younger than 18yr，older than 45yr or pregnancy;
* Those who were not willing to or could not finish the whole study at any time;
* The PACU assessing score was under 6 on a scale of 10 (measuring somnolence, respiration, movement, color, and blood pressure on 0-2 scales), and arterial oxygen saturation measured by pulse oximetry (SaO2) was 92% or lower (supplemental oxygen was permitted).
Registry of Catheter Intervention in Pulmonary Embolism

Multicenter longitudinal observational ambispective (retrospective cases from 2014 and prospective from 2018 onwards) cohort study. The registry recruits a series of consecutive patients admitted for moderate-high risk or high-risk pulmonary embolism (according to 2019 European Society of Cardiology guidelines) treated invasively. This study aims to describe the acute management of the safety and effectiveness of different percutaneous interventions for acute pulmonary embolism.


Eligibility Criteria:
Inclusion Criteria:

* adult patients (aged 18 years old or older)
* confirmed diagnosis of acute PE (on computed tomography or echocardiogram plus pulmonary angiography)
* high-risk PE or intermediate-high risk according to ESC risk stratification in the 2019 guidelines (briefly, elevated cardiac biomarkers \[troponin or N-terminal pro-B-type natriuretic peptide\], and right ventricle to left ventricle ratio \> 0.9 \[on computed tomography or echocardiogram\], and PE severity index III to IV or simplified PE severity index=1
* eligibility for catheter-directed intervention

Exclusion Criteria:

* unconfirmed diagnosis of PE
* undefined risk stratification, and
* PE with uncertain chronology or beyond seven days of symptom initiation.
In Vivo Dosimetry During Prostate Cancer Radiotherapy

The goal of this clinical research study is to learn if a rectal balloon with attached radiation detectors can be used to help researchers monitor the dose of external beam radiation that is delivered to the prostate during treatment. This may help researchers better understand the side effects of radiation therapy, such as rectal bleeding, and may lead to changes in treatment planning or treatment delivery.

As a part of your standard of care, you will have external beam radiation therapy. You will have a computerized tomography (CT) scan of the pelvis before the external beam radiation therapy.

For the CT scan, you will be given an enema to empty your bowel, and you will drink about 16 to 24 ounces of water to fill your bladder

A rectal balloon will then be inserted into your rectum and filled with either air or water. You will then have the CT scan. The CT scan should take about 45 minutes.

If you agree to take part in this study, very thin (millimeter-sized) radiation detectors will be attached to the rectal balloon during each of two CT scans per week you will have while you are receiving radiation. You may have additional CT scans (without the detector) each week if your doctor thinks it is needed.

The doses read by the radiation detectors will be compared to the doses that you were originally scheduled to receive after each radiation treatment and at the end of the study.

You will be off study after your final radiation treatment using the rectal balloon.

This is an investigational study. Up to 15 patients will take part in this study. All will be enrolled at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Any patients with prostate cancer who are undergoing routine radiation therapy for their prostate cancer, including post-prostatectomy patients.
2. The selection criteria will be limited to the patient's ability to withstand insertion of a rectal balloon and his willingness to participate in the study.
3. We will choose patients undergoing photon and proton treatments.

Exclusion Criteria:

N/A
Clinical Trial of Vagus Nerve Stimulation for Treatment of Refractory Epilepsy

Evaluate the long-term clinical effectiveness and safety of the PINS vagus nerve stimulator to patients with refractory epilepsy.


Eligibility Criteria:
Inclusion Criteria:

1. Age 6-60.
2. Having tried at least two appropriate anti-epileptic drugs (AEDs) tested to tolerance or to blood levels at upper end of the target range of which at least 2 have been tolerated at normal dose.
3. At least 1 seizure per month.
4. In good health except epilepsy.
5. With normal MMSE score
6. Patients or his(her) familyscould understand this method and sign the informed consent 7）Patients with good compliance and could complete postoperative follow-up.

Exclusion Criteria:

1. Results of MRI remind epilepsy caused by intracranial space-occupying lesions.
2. The vagus nerve lesion and damage
3. Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，pepticulcer，diabetes Type 1，bad health etc, and other surgical contraindication
4. Alcohol addiction, smoking, and sleep-related breathing disorders
Effects of Infant Egg Consumption on Child Health and Cognition Development

The objective of this study is to examine how infant egg consumption (age of introduction and frequency of intake) influences physical growth, obesity, cardio-metabolic health, risk of food allergy, and cognition development in mid-childhood and adolescence.

The investigators will use existing data from two US longitudinal birth cohorts that tracked mother-child dyads from pregnancy to adolescence: 1) Project Viva (1999-present) that enrolled 2,341 pregnancies and followed 2,128 children at delivery, 6 months, then yearly from 1 year to 15 years of child age, and 2) the Infant Feeding Practices Study II (IFPS II, 2005-2007) that enrolled 3,033 pregnancies with surveys in late pregnancy, neonatal (1 month), then monthly from 2 months (N=2,552) to 12 months of infant age, and at 6 years. For Aim 1, the investigators will classify infants based on their age of egg introduction: never, \<2 months, 2-3 months, 4-5 months, 6-8 months, 9-11 months, and 12 months. The investigators will compare physical growth, obesity, cardio-metabolic health, food allergy, and cognition test scores in mid-childhood and adolescence. The investigators will fit multi-variable linear or logistic regression models with fractional polynomial functions of the infant age of egg introduction. Both linear (e.g., earlier introduction, a higher probability of the outcome) and non-linear (e.g., threshold effect) associations will be tested. For Aim 2, The investigators will classify infants based on their frequency of egg intake: never, \<once/week, once/week, 2-4 times/week, nearly daily or daily, and 2 times/day. The investigators will use similar analytic methods mentioned above to compare their later outcomes. Finally, the investigators will create an average probability of multiple child outcomes to balance across different aspects of child health and development. The investigators will identify the lowest-risk infant egg consumption when the corresponding average predicted probability of the related adverse outcomes is the lowest.

Eligibility Criteria:
Inclusion Criteria:

* Children with complete data on infant egg consumption and the corresponding health and cognition outcomes.

Exclusion Criteria:

* None.
Novel Text-Messaging Bot in Patients Undergoing Joint Arthroplasty

This study evaluates the addition of an automated physician-specific text-messaging (SMS) bot in patients undergoing total joint arthroplasty. Half of the patients received the traditional perioperative education and instructions (control group), while the other half were enrolled in their physician's SMS bot (intervention group).

In an era of value-based reimbursement and high-volume surgery, the patient experience is becoming increasingly important. Despite publicized efforts to place a greater emphasis on patient-centered care, patients often report poor access to their physician, lack of effective perioperative education, and frustration as their care is commoditized.

A text-messaging (SMS) bot has the potential to help fill some of these voids. Bots are computer programs that are inherently automated to simulate human-like tasks. While a physician may wish he or she could contact each of their patients daily, it would be an impossible undertaking for most. An SMS bot could make daily contact possible by automating it, potentially improving patient education and engagement before and after surgery. Standard SMS has been previously reported to be an effective means for delivering timely information, increasing patient compliance and outcomes (medication adherence, decrease surgical infections with antiseptic showers), and reaching a socioeconomically diverse patient population. Further benefits may be seen with an SMS bot due to its automated capabilities.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria consisted of patients over 18 years of age, scheduled for primary total hip \& knee arthroplasty, with smart phone capability, and proficiency in English.

Exclusion Criteria:

* Patients less than 18 years of age, no smart phone capability, poor English proficiency.
Urinary KIM-1 After Vancomycin or Linezolid Administration

Acute renal injury is a common complication of critical illness. Drug induced renal insult compounds the degree of injury in many patients, and a great deal of research has focused on prevention of this complication. Traditional biomarkers of renal injury like serum creatinine and blood urea nitrogen content fail to consistently predict harm among patients at risk. Kidney Injury Molecule 1 (KIM-1) will be studied as a biomarker of renal injury.

see above

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients are male or female adults ≥18 years of age with an expected hospital stay of at least 48 hours.
* Eligible patients are already prescribed intravenous vancomycin or linezolid per their primary care providers as a standard of care and dosed in manner that is consistent with current institutional practices. Receipt of these antibiotics is not investigational.

Exclusion Criteria:

* Exclusion criteria will include patients who have stage 3or greater Chronic Kidney Disease or who have acute kidney injury prior to the start of intravenous vancomycin therapy, patients that only receive one dose of IV vancomycin or linezolid in total, as well as patients with potentially altered pharmacokinetic parameters (pregnant patients, burn patients, and those that are morbidly obese (BMI ≥ 40 kg/m2).
* Additionally, patients will be excluded if they are to receive more than 1 concurrent nephrotoxic medication within the prior 72 hours, have received intravenous contrast within 120 hours before randomization, exhibit baseline hematuria, or baseline proteinuria.
* A list of concurrent nephrotoxins that would exclude patients from the study is provided in Appendix C.
* Age Range: ≥18 years of age, if age \> 90 will report as \> 90 years
Multifocal Electroretinogram in Normal Egyptian Population

Studying normal subjects to create unique normal database for multifocal electroretinogram (mf-ERG) in specific population.

Normal parameters for electroretinogram (ERG) is important in studying specific population, studying normal subjects is important to create specific normal database for each population. This will help in accurate differentiation for various ocular diseases and in research trials.

Eligibility Criteria:
Inclusion Criteria:

* Normal subjects seeking regular ophthalmic check-up at banha university hospital.

Exclusion Criteria:

* Any retinal diseases that may affects mf-ERG waves.
* Subjects with best corrected visual acuity less than 0.7 in decimal form at time of examination.
* Refractive errors more than 0.5 diopter as measured by autorefractometer.
COVID-19 PrEP HCW HCQ Study

Off label study to evaluate the efficacy of HCQ for pre-exposure prophylaxis (PrEP) to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. 350 participants will be assigned to the group that takes HCQ or the group that opts to not take the study medication. Participants will be NYULH HCW at high risk for occupational exposure to SARS-CoV-2. Study timepoints will include screening/enrollment, 30 day, 60 day, and 90 day visits. Questionnaires, and DBS will be collected in all timepoints.

Hydroxychloroquine (HCQ) is licensed for the chemoprophylaxis and treatment of malaria and as a disease modifying antirheumatic drug. It has a long history of being safe and well tolerated at typical doses. HCQ has antiviral activity in vitro against coronaviruses, and specifically Covid-19. This study is designed to evaluate the efficacy of hydroxychloroquine (HCQ) for pre exposure prophylaxis (PrEP) to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among health care workers at high risk of occupational exposure to SARS-CoV-2 compared to the eligible cohort that declines treatment.

Eligibility Criteria:
Inclusion Criteria for Group A and B

* Men or women ages ≥18 years NYULH health care worker who meets one of the following criteria

  1. Involved in an aerosol generating procedure (nasopharyngeal specimen collection, tracheal intubation, nebulizer treatment, open airway suctioning, collection of sputum, tracheostomy, bronchoscopy, CPR) on a confirmed COVID-19 patient while wearing PPE
  2. Direct bedside care of confirmed COVID-19 patient while wearing PPE for 3 or more shifts in a 7 day period
  3. Direct care of PUIs in the ED or other inpatient unit while wearing PPE for 3 or more shifts in a 7 day period
* Willing and able to provide informed consent

Exclusion Criteria for Group A only :

* Known hypersensitivity to hydroxychloroquine or chloroquine
* Known diagnosis of COVID-19
* Concomitant use of

  1. amiodarone
  2. digoxin
  3. flecainide
  4. procainamide
  5. propafenone
* History of Torsades de pontes
* History of retinal disease
* Known chronic kidney disease ≥ stage 4
* Congenital prolonged QTc interval syndrome (Jervell and Lange-Nielsen syndrome, Romano-Ward syndrome)
Surveillance of Metabolic Parameters in Patients With Colorectal Cancer

A prospective, single center, cohort study for surveillance of metabolic parameters in patients who will receive chemotherapy after surgical resection of colorectal cancer

Primary objective - Incidence of newly developed diabetes mellitus in patients with colorectal cancer after post-operative chemotherapy

Secondary objective - Pre-operative incidence of diabetes and characteristics of metabolic parameters of patients with colorectal cancer; Incidence of developed poorly controlled glucose level in diabetic patients with colorectal cancer after post-operative chemotherapy; 3-year recurrence-free survival according to status of diabetes and metabolic parameters; 5-year recurrence-free survival according to status of diabetes and metabolic parameters

Eligibility Criteria:
Inclusion Criteria:

* Who will get surgical resection for colorectal cancer
* Who has diagnosed with diabetes
* Who met the criteria for testing of diabetes in asymptomatic adult individuals
* Criteria for testing for diabetes in asymptomatic adult individuals

  * overweight (BMI\>25 kg/m2\*) and have additional risk factors (physical inactivity, first-degree relative with diabetes, high-risk race/ethnicity (e.g., African American, Latino, Native American, Asian American, Pacific Islander), women who delivered a baby weighing 0.9 lb or were diagnosed with GDM, hypertension (\>140/90 mmHg or on therapy for hypertension), HDL cholesterol level ,35 mg/dL (0.90 mmol/L) and/or a triglyceride level \>250 mg/dL (2.82 mmol/L), women with polycystic ovarian syndrome, HbA1C \>5.7%, IGT, or IFG on previous testing, other clinical conditions associated with insulin resistance (e.g., severe obesity, acanthosis nigricans), history of CVD)

Exclusion Criteria:

* Previously exposed to surgery or chemotherapy for colorectal cancer
* Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence
* Presence of CNS metastasis
* Not able or willing to give informed consent
* Any patients judged by the investigator to be unfit to participate in the study
Clinical Trial to Evaluate the Efficacy and Safety of YHP1701

The purpose of this study is to determine superiority of YHP1701 comparing to each monotherapy in patient with hypertension and primary hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

* Both man and woman who is over 19 years old
* Patient with dyslipidemia and hypertension

Exclusion Criteria:

* sSBP difference is ≥20 mmHg or sDBP difference is ≥10 mmHg
* A history of cardiovascular disease
* Rhabdomyolysis, myopathy
* Hypertension or hypercholesterolemia due to secondary causes
* Uncontrolled diabetes
* Evidence of hepatic or renal disease
Tunisian Registry of Trans Catheter Aortic Valve Implantation

Transcatheter aortic valve implantation (TAVI) has emerged as a transformative therapy for patients with severe aortic stenosis, particularly those designated high-risk or inoperable for traditional surgical valve replacement. Despite its increasing adoption worldwide, there re-mains a paucity of data regarding TAVI outcomes in Tunisian patients. In response to this gap in knowledge, the investigators propose the establishment of the Tunisian TAVI Registry, a multicenter initiative aimed at comprehensively documenting the clinical characteristics, procedural de-tails, and short- and long-term outcomes of TAVI procedures across Tunisia. The TAVI.TN registry will enroll consecutive patients undergoing TAVI procedures at participating centers across Tunisia, between 2013 and 2024 with a retrospective arm and a prospective arm. The TAVI-TN Registry represents a significant step towards enhancing our understanding of TAVI outcomes in the Tunisian population. By systematically capturing real-world data, this initiative aims to inform clinical decision-making, improve patient care, and contribute to the advancement of TAVI practices in Tunisia and beyond.


Eligibility Criteria:
Inclusion Criteria:

- Any Tunisian patient who was treated with TAVI implantation in Tunisia

Exclusion Criteria:

* Patients who are not Tunisians
* Patients not agreeing to sign consent, witnesses not agreeing to sign consent (family member)