cyrilzakka/clinical-trials huggingface dataset:
The Impact of Continuous Transcutaneous CO2 (TCCO2) Monitoring in Extremely Low Birth Weight (ELBW) Infants

An observational study comparing outcomes of Extremely Low Birth Weight (ELBW) infants that were monitored with non-invasive Transcutaneous CO2 (TCCO2) monitor to infants that were not monitored by TCCO2 monitor.


Eligibility Criteria:
Inclusion Criteria:

* ELBW infants Need of respiratory support

Exclusion Criteria:

* Parental refusal IVH before study entry chromosomal abnormalities congenital central nervous system (CNS) abnormalities
Use of the Perinatal Database and Biologic Tissue Bank at The Perinatology Research Branch (PRB)

The purpose of this application is to request permission to use a bank of biological specimens and clinical information collected by the investigators prior to their joining the intramural program. The samples have been gathered under the sponsorship and approval of the Human Investigations Committees at Yale University, Wayne State University and Pennsylvania Hospital in the United States, the Sotero del Rio Hospital, the Hospital of the Universidad de Chile and the Universidad Catolica de Chile , in Chile. The investigators have generated a bank of amniotic fluid, maternal blood and urine, and fetal blood obtained at the time of delivery (from the umbilical cord and by cordocentesis), neonate s urine and sonographic examinations of the fetus, including echocardiography, stored on videotapes. Clinical information with patient identifiers is available for these samples and sonographic examinations.

The purpose of this application is to request permission to use a bank of biological specimens and clinical information collected by the investigators prior to their joining the intramural program. The samples have been gathered under the sponsorship and approval of the Human Investigations Committees at Yale University, Wayne State University and Pennsylvania Hospital in the United States, the Sotero del Rio Hospital, the Hospital of the Universidad de Chile and the Universidad Catolica de Chile , in Chile. The investigators have generated a bank of amniotic fluid, maternal blood and urine, and fetal blood obtained at the time of delivery (from the umbilical cord and by cordocentesis), neonate s urine and sonographic examinations of the fetus, including echocardiography, stored on videotapes. Clinical information with patient identifiers is available for these samples and sonographic examinations.

Eligibility Criteria:
* Not listed in protocol - samples only.
Vaccine Hesitancy in Patients with Solid Tumors: a Cross-sectional Single-center Survey

Cancer patients have a well-known and higher risk of vaccine-preventable disease (VPD) than the general population. VPD can cause serious complications due to compromised immune system, malnutrition and the same oncology treatments and represent a severe financial burden with a delay in treating the underlying cancer The main purpose of this survey is to analyse the perception of cancer patients on the topic vaccines and vaccine-preventable diseases, the acceptability of vaccines and the evaluation of the determining factors associated with the choice of the patient to be vaccinated or not. This information will be used to improve the management of these issues.


Eligibility Criteria:
Inclusion Criteria:

1. \>18 years of age;
2. Oncology patient defined as a patient with solid tumors undergoing active systemic treatment or follow-up;
3. Written informed consent

Exclusion Criteria:

1. Patients with hematological tumors
2. Patients who are unable to understand informed consent document
Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab

To assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over 26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with infliximab


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Crohn's Disease
* Previous treatment failure to Infliximab (intolerance and/or no response)

Exclusion Criteria:

* Obstructive intestinal strictures
* Recent bowel resection
* Proctocolectomy or total colectomy
* Current total parenteral nutrition
* Short bowel syndrome
* All concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient
* Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial
Family Based Mindfulness Intervention

The goal of the proposed interdisciplinary study is to assess feasibility of recruiting a pilot sample of parents of toddlers and engaging them in a pilot study to test a version of mindfulness-based intervention for parenting stress reduction (PMH), an empirically-supported stress-reduction intervention, plus nutrition and physical activity counseling for parents of preschoolers (aged 2-5); to reduce parent (and child) stress levels; improve parenting; promote healthy eating and physical activity in parent and child; and prevent overweight and obesity in preschoolers with an obese parent.

This project was a preliminary feasibility and pilot efficacy study to assess stressed low income parents of toddlers who were obese to assess whether a mindfulness based parenting intervention (PMH) can reduce their stress, increase parenting and improve family healthy food and physical activity choices. Parents and toddlers also participated in a Toy Wait Task, a behavioral assay of parenting.The empirically-supported stress-reduction intervention, plus nutrition and physical activity counseling (Control) for parents of preschoolers (aged 2-5) was compared to a nutrition and physical activity counseling alone condition to assess whether PMH improved toddler weight, physical activity and parent emotion regulation and healthy eating.

Eligibility Criteria:
Inclusion Criteria:

1. Between ages 18-70 years;
2. Able to read and write (parent)
3. Family with a child between 2-5 years old
4. BMI of parent in obese category
5. High parenting stress (mean score of \>=3 on 3 questions from Parenting Stress Index)

Exclusion Criteria:

1. Any psychotic disorder or current psychiatric symptoms for child or parent requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation
2. Diagnosis of mental retardation, autism or other pervasive developmental disorder for child
3. Inability to give informed consent
4. Current serious medical disorder precluding participation in physical activity
Evaluating The Cardiovascular Effects of Tourniquet Application

The goal of this prospective observational study is to investigate the impact of tourniquet application on cardiac efficiency through the cardiac cycle efficiency parameter and to explore how central regional technique alters this effect compared to general anesthesia.

We aim to answer the following main questions: 1) Does the use of a tourniquet reduce cardiac efficiency? 2) Does the impact of tourniquet use on cardiac efficiency vary with general anesthesia or central regional technique? The patients included in the study will be divided into two groups based on whether they receive general anesthesia or combined spinal epidural anesthesia.The patients' cardiac cycle efficiency and advanced hemodynamic monitoring parameters will be recorded during procedure.

After obtaining ethical committee approval (ATADEK; 2022-14/12), 43 patients undergoing elective unilateral total knee arthroplasty under tourniquet were enrolled in our prospective observational study. Patients were divided into two groups: general anesthesia (Group GA: 22 patients) or combined spinal epidural anesthesia (Group CSEA: 21 patients). Cardiac and vascular parameters were recorded using the new algorithmic application of arterial wave analysis called Pressure Recording Analytical Method (PRAM) at 9 time points: (T1) pre-anesthesia, (T2) post-anesthesia before tourniquet inflation, (T3-8) during tourniquet inflation, and (T9) after tourniquet deflation.

Eligibility Criteria:
Inclusion Criteria:

* Planned for Elective Unilateral Total Knee Arthroplasty Under Tourniquet Application
* Aged 18 and over
* Either general anesthesia (GA) or combined spinal-epidural anesthesia (CSEA) will be administered

Exclusion Criteria:

* Patients under 18 years of age
* Patients with heart failure
* Patients with valve disease
* Patients with rhythm disorders
* Patients with a history of myocardial infarction in the last 3 months
* Patients unwilling to provide consent
A Study of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease.


Eligibility Criteria:
Inclusion Criteria:

1. Patients show presence of hepatic fat fraction as defined by ≥ 10% on MRI-PDFF at Screening
2. Patients show presence of liver stiffness as defined by ≥ 2.5 kPa on MRE at Screening
3. Patients have an ALT above the upper limits of normal (30 IU/L for females and 40 IU/L for males) at Screening
4. Patients with NAFLD had to be age 20 years or older at written informed consent(ICF)

Exclusion Criteria:

1. Current of significant alcohol consumption (significant alcohol consumption is defined as more than 210 g/week in males and more than 140 g/week in females, on average)
2. Planned use of Contraindicated Medications from written ICF to end of treatment.
3. BMI \< 22 kg/m2 at Screening
4. Uncontrolled diabetes mellitus as defined by a HbA1c(NGSP) ≥ 8.0％ at Screening
5. eGFR \< 30 mL/min/1.73m2 or Dialysis patient
6. Cirrhosis
7. Biliary obstruction
8. Patients were excluded if they had evidence of other forms of liver disease shown by the following:

   * Hepatitis B or Hepatitis C
   * Autoimmune hepatitis（AIH）
   * Primary biliary cirrhosis（PBC）
   * Primary Sclerosing Cholangitis（PSC）
   * Drug-induced liver injury
   * hyperthyroidism, Wilson's disease, hemochromatosis, alpha-1-antitrypsin disease
9. Those with complicating malignant neoplasm or those judged to be at a high risk of recurrence
10. Patients with contraindications to MRI imaging
11. Patients who gave 200 mL or more of blood within 1 month before the administration of the study drug, or 400 mL or more of blood within 4 months before the administration of the study drug
12. Patients with a history of serious drug allergies (such as anaphylactic shock)
13. Pregnancy, breast feeding, planned pregnancy
14. Patients who were participating in another clinical study at the time of consent was obtained or who received study drugs other than the placebo less than 16 weeks before consent was obtained
15. Patients who have previously been administered pemafibrate
16. Patients who have been determined inappropriate by the investigator or subinvestigator
Physiological Complexity of Pediatric Surgery Between Types of Hospitals

When considered from a provincial perspective, quantification of surgical procedures undertaken by different hospitals and healthcare networks is necessary for informing resource allocation and modelling of healthcare services. The investigators hypothesized that i) non-physiologically complex surgical procedures would account for most (\>1/2) of pediatric surgical procedures performed at both pediatric specialist hospitals and the other hospitals performing pediatric surgery, ii) surgical discharges for non-physiologically complex surgical procedures would account for most (\>1/2) in-hospital bed nights among pediatric surgical admissions at both pediatric specialist hospitals and the other hospitals performing pediatric surgery, and iii) the relative distributions of non-physiologically complex surgical procedures, but not physiologically complex procedures, would be at least moderately similar between pediatric specialist hospitals and the other hospitals performing pediatric surgery. To test these 3 hypotheses, the specific objectives of this study were to estimate i) the proportion (primary outcome) of non-physiologically complex pediatric surgical procedures, and ii) the similarity and diversity (secondary outcomes) of non-physiologically and physiologically complex surgical procedures between the pediatric specialist hospitals and the other hospitals performing pediatric surgery in Ontario, Canada.


Eligibility Criteria:
Inclusion Criteria:

* surgical procedures for individuals aged greater than 27 days and less than 18 years

Exclusion Criteria:

* newborns (0 to 27 days of age)
* records lacking a patient identifier or age
* non-surgical healthcare interventions
Executive Functions Computerized Rehabilitation Using Virtual Reality to Improve Activities of Daily Living Post-stroke

This research aims to evaluate the effects of a cognitive reeducation carried out with the COVIRTUA Cognition software using a virtual environment, on real-life execution of activities of daily living (ADL) for patients with post-stroke dysexecutive disorders. We will assess patients' performances in achieving ADLs by the Goal Attainment Scaling (GAS) throughout the follow-up (3 months), based on the goals set at the beginning of management with each patient.

Many post-stroke patients, especially those with frontal lobe lesions, have chronic impairments in mental flexibility, leading to difficulties in decision-making, action planning, or behavioural perseverance. Techniques for remediation of these dysexecutive disorders are often performed in a hospital or in a liberal office. The possible progress resulting from this rehabilitation is rarely transposed into the patient daily life performances, executed in a richer and less controlled environment than the usual place of re-educational. Here, we wish to assess the effective benefits (i.e. in carrying out the activities of daily living) of a computerized rehabilitation program addressing executive functions and based on virtual reality, simulating ADLs. We use in this study a multiple baseline single case experimental design (AB design with a follow-up beyond), including for each patient: pretreatment (phase A), treatment (phase B), and follow-up phase.

Pretreatment includes a routine sensitivomotor neurological rehabilitation program that doesn't specifically target executive functions in daily living activities (3 to 5 weeks depending on randomization). Treatment consists in a 4 weeks virtual reality cognitive training program, including four 45-minute sessions per week with an occupational therapist for cognitive rehabilitation in a virtual environment with the COVIRTUA Cognition software. The follow-up phase (5 to 3 weeks depending on randomization) includes no support for executive functions, either in a rehabilitation centre or in a liberal office.

Eligibility Criteria:
Inclusion Criteria:

* Vascular brain injury (stroke), in chronic phase (6 months or more after stroke), responsible for dysexecutive syndrome authenticated by the GREFEX/GRECO battery (Executive Function Evaluation Reflection Group)
* Men and women over the age of 18
* Presence of a caregiver
* Social Security affiliation
* Signing free and informed consent following clear and detailed information
* Sufficient understanding of the French language to participate in the study

Exclusion Criteria:

* Pregnant women (clinical examination)
* Alcohol and/or narcotics addiction
* Major hearing deficit
* Major visual deficit
* Neurological pathology other than stroke or psychiatric disorder
* Unstable epilepsy
* Patient undergoing rehabilitation at a liberal therapist targeting executive functions during study time
* Patient under safeguard of justice.
* Patient simultaneously participating in another research study
NSAID Use After Robotic Partial Nephrectomy

The purpose of this study is to see how effective non-steroidal anti-inflammatory drugs (NSAIDs) are at controlling pain without side effects in participants after robotic-assisted partial nephrectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing uncomplicated robotic assisted laparoscopic partial nephrectomy for renal mass at the University of Miami Hospital and Network Sites (Deerfield Beach, Plantation, Lennar (Coral Gables), and Kendal).
* Age 18-99.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Allergy to NSAIDs
* Myocardial infarction or unstable angina within 12 months.
* Any history of coronary artery bypass graft surgery.
* History or active peptic ulcer disease, gastrointestinal (GI) bleeding, GI perforation. History of bleeding disorder. Glomerular filtration rate (GFR) \< 60 mL/min/1.73m2 (Modification of Diet in Renal Disease (MDRD) equation).
* Taking any anti-platelet or anti-coagulation medications concurrently (e.g. warfarin, aspirin, clopidogrel, rivaroxaban etc.)
* Chronic opioid use (use within 12 weeks) or history of opioid use disorder.
* Solitary kidney.
* Pregnancy.
* Inability to give informed consent or unable to meet requirement of the study for any reason.
A Study to Evaluate Eli Lilly's Insulin Dosing Algorithm to Control Glycemia in Insulin-treated Adults With Type 2 Diabetes

The objective of this study is to generate preliminary data in an inpatient setting to help optimize an insulin dosing logic (that decides how much to deliver insulin) for Eli Lilly's system.

After being informed about the study and potential risks, all participants giving written informed consent will undergo an admission visit to determine eligibility for study entry. Participants who meet the inclusion and exclusion criteria will then participate in two 41-hour intervention visits using Eli Lilly's insulin dosing algorithm.

Eligibility Criteria:
Inclusion Criteria:

To be eligible for the study, all participants must meet the following criteria:

1. Adult male or female ≥ 18 years of age.
2. Type 2 diabetes mellitus has been clinically diagnosed (the diagnosis of type 2 diabetes is based on the investigator's judgment) for at least 12 months
3. Using multiple daily insulin injections (one basal and ≥ 2 prandial doses) for ≥ 3 months.
4. Using insulin glargine (U100 or U300), detemir, degludec, or NPH.
5. Most recent (in the last 6 month) HbA1c ≤ 10%.
6. Use of a GLP1 agonist or SGLT inhibitor for the past 3 months.

Exclusion Criteria:

Participants who meet any of the following criteria are not eligible for the study:

1. Severe hypoglycaemic episode ≤ two months before admission.
2. Ongoing pregnancy, or any newly diagnosed pregnancy throughout the study
3. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
4. Recent (within the past 6 months) acute macrovascular event (e.g. acute coronary syndrome or cardiac surgery).
5. Peripheral vascular disease, foot ulcer, Charcot arthropathy or any condition that limits ability to walk
6. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
7. Use of oral hypoglycaemic agents besides SGLTi's, GLP1 agonists, and or metformin and unwilling to discontinue for the run-in and intervention period.
Computational MOdelliNg of MyoCardial PERfusion to Improve OuTcome Prediction Based on COronary Artery Stenosis and Atherosclerotic Plaque Burden Assessment by Computed Tomography

Detection of coronary stenosis is of utmost importance in identifying vulnerable patients. The combined use of coronary computed tomography angiography at rest (CCTA) and stress myocardial computed tomography perfusion (stress-CTP) provides both anatomic and functional analysis of coronary artery disease (CAD) using a single imaging test. Stress-CTP evaluates myocardial perfusion by measuring myocardial blood flow (MBF) under pharmacologically induced stress conditions. The drawback is that stress-CTP requires additional scanning and administration of an intravenous stressor with an increase in radiation exposure and potential stressor-related side effects. The investigators recently patented a computational model that can reproduce MBF under stress conditions (Italian patent n. 102021000031475 Metodo implementato mediante computer per la simulazione del flusso sanguigno miocardico in condizioni di stress \[Computational method for simulating myocardial blood flow in stress conditions\], half owned by Centro Cardiologico Monzino, half by Politecnico di Milano).

On top of this, CCTA can characterize plaque type and identify adverse plaque characteristics. Moreover, biomechanics analysis allows the study of luminal stenosis and stress within the plaque. Finally, radiomics, extracting quantitative features from medical images to create big data and identify novel imaging biomarkers, can be applied to improve the diagnostic accuracy of coronary plaques.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic patients with suspected CAD referred for nonemergent, clinically indicated non-invasive coronary angiography.

Exclusion Criteria:

* Low pre-test likelihood of CAD
* Prior myocardial infarction
* Previous history of revascularization
* Acute coronary syndrome
* Need for an emergent procedure
* Evidence of clinical instability
* Contraindication for contrast agent or impaired renal function
* Inability to sustain a breath-hold
* Pregnancy
* Atrial fibrillation or flutter
* BMI \> 35kg/m2
* Presence of pm or ICD
* Contraindications to the administration of sublingual nitrates, betablockade, and adenosine
EXActDNA-003 / NSABP B-64: Study of Molecular Residual Disease Detection in Breast Cancer (MRD)

The EXActDNA-003 study will prospectively enroll participants who are planning to undergo chemotherapy for high-risk, early breast cancer, who are willing to provide tissue and blood specimens for circulating tumor DNA (ctDNA) analysis.

Participants will be followed for up to 5.5 years.


Eligibility Criteria:
Inclusion Criteria:

1. The participant or a legally authorized representative must provide study-specific informed consent prior to study entry.
2. The participant must be ≥ 18 years of age.
3. ECOG performance status 0 or 1.
4. Histologically confirmed invasive carcinoma of the breast.
5. Planned neoadjuvant therapy which includes cytotoxic chemotherapy.
6. Tumor size ≥ 2.1 cm in greatest diameter.
7. Unifocal or multifocal cancer documented to be the same histologic clinical subtype.
8. Clinically node positive or if node negative, any one of the following:

   1. TNBC or HER2+ subtype
   2. HR+/HER2-negative with at least one of the following:

   i. High tumor grade (G3) ii. Ki67 index of 20% or higher iii. High genomic risk (Oncotype DX® (ODX) Breast Recurrence Score of \> 25, MammaPrint® High, etc.)
9. Willing and able to comply with the study requirements, which includes the collection of a total of 34 cc (2.5 Tablespoons) of blood for each research blood draw.
10. Available residual tissue from diagnostic biopsy from the breast or an involved ipsilateral lymph node for submission to create a bespoke ctDNA assay.

Exclusion Criteria:

1. Definitive clinical or radiologic evidence of metastatic disease.
2. Initiated neoadjuvant therapy for current breast cancer diagnosis.
3. Synchronous diagnosis of another invasive cancer, other than this breast cancer, except for non-melanoma skin cancers.
4. Completed all therapy (including endocrine therapy) \<5 years ago for any previous invasive solid organ malignancy (with exception of non-melanoma skin cancers) including prior breast cancer. Individuals with a prior history of noninvasive (in situ) carcinomas may participate if they have received definitive treatment.
5. Completed all therapy for any previous hematologic malignancy \< 5 years ago.
6. Multicentric or contralateral invasive breast cancers.
7. Known pregnancy at time of enrollment.
8. Prior solid organ transplant.
9. Prior allogeneic hematopoietic stem cell transplant.