cyrilzakka/clinical-trials huggingface dataset:
Usability of Blood Glucose Control With the Space TGC System in Medical ICU Patients

Hyperglycemia is common in critically ill patients and associated with an adverse outcome. Thus, glycaemic control is an important issue in critical care. Despite extensive efforts of the intensive care unit staff difficulties were experienced in achieving efficient and safe glucose control. A fully automated algorithm may help to overcome some of these limitations by excluding intuitive interventions and integrating relevant clinical data in the decision-making process. Space GlucoseControl (TGC system) is a decision support system which helps to achieve safe and reliable blood glucose control in the desired ranges. Information on parenteral and enteral nutrition is automatically integrated into the calculations. The primary objective of the current study is to investigate the performance and usability of the Space TGC system for glucose control in medical ICU patients.


Eligibility Criteria:
Inclusion:

* Age: \> 18 years of age
* Stay in the ICU expected to be \> 72 h
* Blood glucose \> 6.1 mmol/L or patient on insulin treatment

Exclusion:

* Patients with hyperglycaemic crisis/ketoacidosis due to insulin deficiency.
* Known or suspected allergy to insulin
* Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient (i.e., liver failure, other fatal organ failures)
* Moribund patients likely to die within 24 hours
Prochymal® Expanded Access for Adults Who Have Failed Steroid Treatment for Acute Graft Versus Host Disease (GVHD)

This protocol allows for the treatment of patients, male and female, between the ages of 18 years and 70 years. Patients must have failed to respond to steroid treatment for Grade C-D acute GVHD.

This is a treatment protocol to provide patients who have failed steroid treatment for acute GVHD expanded access of Prochymal. It is anticipated that a maximum of 10 patients per month for a total of 120 patients per year will be treated according to this protocol.

Patients will be treated with Prochymal twice per week at a dose of 2 x 106 human mesenchymal stem cell (hMSC)/kg (actual body weight) for each of 4 consecutive weeks. Infusions will be administered at least 3 days apart.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years to 70 years of age, inclusive.
* Biopsy confirmation of GVHD is strongly recommended, to exclude patients presenting with diarrhea or abnormal liver function tests caused by infection.
* Patients must have failed to respond to steroid treatment (methylprednisolone \[≥1mg/kg/day\] or equivalent) for Grades C-D acute GVHD.
* Prochymal must be administered not longer than 14 days after the initiation of systemic steroid therapy for acute GVHD.
* Prochymal must be administered either before or at the same time any additional GVHD therapy is administered
* Patients must have an adequate renal function as defined by Cockcroft-Gault equation:Calculated creatinine clearance (CrCl) \> 30 mL/min
* Patients who are women of childbearing potential, must be non-pregnant, not breast-feeding, and use adequate contraception. Male patients must use adequate contraception.

Exclusion Criteria:

* Patient has stage 3 or 4 liver GVHD, bilirubin \>6 mg/dl.
* Patient has stage 4 GI-GVHD.
* Patient has any underlying or current medical condition that would interfere with the evaluation of the patient including uncontrolled infection, sepsis, organ failure, etc or any medical condition that has a high probability of causing death in less than 30 days.
* Patient may not receive any other investigational agent (not approved by the FDA for any indication) concurrently for the duration of the protocol.
* Patient has evidence of a pulmonary infiltrate or diffuse alveolar hemorrhage and must not be likely to require more than 2 liters of oxygen via face mask or an estimated fractional inspired oxygen concentration (FiO2) of 28% via other delivery methods in order to sustain an O2 saturation of 92% during the next 3 days.
* Patient has a known allergy to bovine or porcine products
* Patient has a medical history of a solid tumor disease.
How to Report Postoperative Outcomes After a Paediatric Cardiac Surgery ?

Congenital heart disease is a common abnormality in newborns. The marked improvement in the surgical management of congenital heart disease has led to a reduction in postoperative mortality, historically a quality criterion for surgical and resuscitation management. With the improvement of medical knowledge and surgical techniques, mortality is no longer a single quality criterion for a center and the search for other quality criteria is essential.


Eligibility Criteria:
Inclusion criteria:

* Minor patients, under the age of 18
* operated at the HUS between 01/01/2010 and 03/31/2022 for transposition surgery of the great vessels (arterial switch) with or without CIV; or isolated ventricular septal closure
* Child or holders of parental authority who do not object to the reuse of their data for scientific research purposes.

Exclusion criteria:

* Transposition surgery of the great vessels associated with coarctation of the aorta, pulmonary stenosis or any other complex malformation
* Surgical technique different from the arterial switch for the transpositions of the great vessels
* Closure of interventricular communication associated with another complex heart malformation (tetralogy of Fallot, atrioventricular canal, right ventricle with double outlet, etc.)
* Child or holders of parental authority who have expressed their opposition to the reuse of their data for scientific research purposes.
Added Benefits of Lachrymal Substitute Gel During the Night in Patients With Moderate to Severe Dry Eye Syndrome

Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the elderly population. Topically administered lubricants are the basis for treatment of this disease.

Relief of symptoms in patients with moderate to severe dry eye disease is usually reached by the use of artificial tears during the day. Nighttime relief is often achieved by substances known to be more adhesive to the ocular surface, such as gels.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged over 18 years
2. Signed and dated written informed consent.
3. History of dry eye syndrome for at least 3 months
4. Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 5 mm and ≥ 2mm
5. OSDI ≥ 22
6. Normal ophthalmic findings except dry eye syndrome
7. No administration of topical lubricants 24 hours before the screening examination

Exclusion Criteria:

1. Presence of an ocular pathology judged by the investigator as incompatible with the study.
2. Any other clinical relevant ocular abnormality except DES.
3. History of allergy, known hypersensitivity to one of the components: the administered medical device product, fluorescein or lissamine green
4. History of known clinically relevant allergy
5. Medical or surgical history judged by the investigator to be incompatible with the study participation (hepatic or renal insufficiency; all chronic severe organic disease: metabolic, endocrine, neoplastic, hematological disease; severe psychiatric illness, etc.).
6. History of a recent acute illness with a recovery period within the 2 weeks before the inclusion visit (Day 0).
7. Pregnancy, lactation.
8. Pre-menopausal woman who is not using a reliable birth control method (oral contraceptives or coil) or is not surgically sterilized.
9. Participation in any high-speed or water-sports during the study without ocular protection (goggles or glasses).
10. Subject unable to understand the study instructions or unlikely to comply with the study schedule and treatment.
11. Participation in another clinical study in the 4 weeks before the start of the present study or at the same time as the present study.
A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)

The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of a vaccine-based immunotherapy regimen for patients with prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of prostate cancer
* Adequate bone marrow, kidney and liver function
* Hormone sensitive relapsing prostate cancer after definitive local therapy (biochemical relapse) OR
* Failed prior therapy with a novel hormone (e.g. enzalutamide, abiraterone) with documented progressive disease (post-novel hormone therapy CRPC)

Exclusion Criteria:

* ECOG performance status greater than or equal to 2
* Concurrent immunotherapy for prostate cancer
* History of or active autoimmune disorders (including but not limited to: myasthenia gravis, thyroiditis, pneumonitis, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, scleroderma) and other conditions that disorganize or alter the immune system.
* History of inflammatory bowel disease.
* Current use of any implanted electronic stimulation device
* For biochemically relapsed patients, no concurrent use of ADT or orchiectomy and no known prior or current evidence of any metastatic involvement of distant organs
* For post-novel hormone patients, no concurrent treatment with a secondary hormone (e.g. enzalutamide, abiraterone), no metastasis to the liver or brain
A Safety Study of LY3462817 and LY3509754 in Participants With Psoriasis

This study is being conducted to determine how safe and how well tolerated LY3462817 is when given to participants with psoriasis. Blood tests will be done to check how much LY3462817 is in the bloodstream and how long the body takes to get rid of it. The study will last up to one year and one month for each participant. As part of protocol addendum, this study is additionally evaluating the safety and tolerability of LY3509754 in participants with psoriasis. Blood tests will be done to check how much LY3509754 is in the bloodstream and how long the body takes to get rid of it. The addendum will last up to 12 weeks for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have been diagnosed with psoriasis for at least 6 months
* Participants must have active psoriasis plaques
* Participants must be willing and able to have skin biopsies (small samples of skin removed for testing)

Exclusion Criteria:

* Participants must not have received certain medications for psoriasis that are applied to the skin within 14 days prior to baseline (Day 1)
* Participants must not have received certain oral or injectable medications or light therapy for psoriasis within 4 weeks prior to baseline
High Flow Oxygen During Spontaneous Breathing Trial in Patients With High Weaning Risk Failure: Impact on the Weaning Course at D7 From the First Spontaneous Breathing Trial.

In intensive care unit (ICU), mechanical ventilation (MV) is part of routine care.

Weaning phase is a daily preoccupation for the caregivers. Prolonged MV can lead to many complications. Failing the weaning phase expose the patient to the need for reintubation, that improves the mortality.

The caregiver faces a major problem, in one hand the need to wean properly and quickly and on the other the risk of reintubation.

In order to help the clinician making the good choice, the spontaneous breathing trial (SBT) is a key tool. The international literature provides the investigators many ways to perform the SBT. The most common is the T-piece; the patient is disconnected from the ventilator and connected to a T-piece that can provide supplemental oxygen. Another one is the Support pressure trial, the patient is still connected to the ventilator, but the setups are changed to recreate the T-piece conditions.

In many French ICU's, the SBT is performed by using a heat humidifier filter that is directly connected to the endotracheal tube, this filter allows the clinician to provide supplemental oxygen in accordance with the patient need.

In high risk for reintubation patients, the SBT can create physical stress, that lead to prolonged MV.

In our ICU, for those patients, the investigators perform the SBT by connecting the patient to a device that provides high flow oxygen trough endotracheal connector for tracheotomy.

The investigators hypothesis that high flow oxygen SBT, will allow the high risk for reintubation patients to succeed the SBT.

The investigators proposed to compare 2 strategies for SBT in high risk for reintubation patients:

1. Classic SBT (C-SBT)
2. High Flow Oxygen SBT (HFO-SBT)

This prospective randomized study had 2 conjoint primary outcome:

1. The HFO-SBT shows a better actuarial rate for extubation at day 7 from the begin of the weaning phase
2. Compare the reintubation rate at D7 from the extubation

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 yrs.
* Admission in ICU
* Mechanically ventilated \> 24 hours
* Mechanically ventilated using support ventilation mode
* Patient with one of these criterion:

  * Cardiac disease (left ventricular dysfunction LVEF \<46%, antecedent of ischemic heart disease, antecedent of acute pulmonary edema)
  * Respiratory disease (COPD, Emphysema, bronchectiasis, asthma, obesity-hypoventilation syndrome, restrictive pulmonary disease)
* Informed and signed consent from the patient or next of kin.

Exclusion Criteria:

* Head trauma as a cause for ICU admission
* Neuromuscular disease prior ICU admission
* Tracheotomized patient
* Pregnancy
* Decision not to forgo life sustaining therapy
* Patient not affiliated with a social security organism
* Adult private from his liberty with judicial decision
* Patient that have already been included in the study
Comparative Analysis of Glaucoma Screening Uptake Among First-Degree Relatives in Community-Based and Hospital-Based Approaches

In conclusion, the study shows that the hospital-based group had a significantly higher screening uptake than the community-based group, reflecting that information from ophthalmologists and registered ophthalmic nurses is more effective and well-received than that from village health volunteers. The study suggests that increasing education and support for village health volunteers could enhance screening uptake. Factors influencing uptake include the age of FDRs, place of residence, education, presenting VA of probands, and treatment of probands. Utilizing this study's findings, spreading knowledge and training health officials at the district and sub-district levels could increase understanding of glaucoma and improve communication with the general public and at-risk groups, potentially increasing the response rate. Additionally, implementing a national free screening glaucoma program for at-risk populations, both in and outside hospitals, and organizing mobile screening units at the district level could be an effective prevention strategy against permanent vision loss from glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* All patients with POAG who had a treatment history in the ophthalmology outpatient department of Prapokklao Hospital, Chanthaburi Province, were identified from the Electronic Medical Record (EMR) database with the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10) " Primary open angle glaucoma H40.1" between 1 january 2022 to 31 october 2022. A total of 1304 patients were included in this study.

Exclusion Criteria:

* Excluding those with closed-angle glaucoma and secondary glaucoma due to other conditions such as accidents, post-surgical complications, uveitis, or congenital.
Studying Biomarkers in Samples From Younger Patients With Acute Myeloid Leukemia

This laboratory study is looking into biomarkers in samples from younger patients with acute myeloid leukemia. Studying samples of bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer

Study Subtype: Observational Observational Study Model: Case-control Time Perspective: Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: Cryopreserved bone marrow samples Study Population Description: Patient samples with the AML1-ETO translocation and cytologically normal AML samples for controls Sampling Method: Non-Probability Sample

OBJECTIVES:

I. To address whether the mutation-specific cell-surface markers observed in murine system will allow the prospective isolation of leukemia stem cells (LSC) from human bone marrow samples that have the same cytogenetic abnormalities.

II. To compare the incidence of leukemia in NSG mice that have received CD34+CD38 marker+ cells to NSG mice that receive what are hypothesized to be normal cells (CD34+CD38 marker-subset) from the same patient.

OUTLINE:

Samples and controls are sorted and re-sorted for CD34, CD38, and CD55 subsets by single-cell polymerase chain reaction (PCR) analysis, flow cytometry, and reverse-transcriptase PCR. Sorted cell subsets are then transplanted into NSG mice. Beginning 6 weeks after transplantation, peripheral blood samples are collected and analyzed for human lymphoid- and myeloid-lineage cells by fluorescence-activated cell sorting (FACS).

Eligibility Criteria:
Inclusion Criteria:

* Frozen bone marrow aspirates obtained from childhood acute myeloid leukemia (AML) patients possessing defined cytogenetic mutations; AML1-ETO or inv(16)
* Samples of cytogenetically normal AML cases obtained from the University of Alabama at Birmingham (UAB) as controls
Public Health Messages to Address Vaccine Hesitancy

Views on vaccines range from those who are strongly supportive to those who are stridently opposed and will not budge from identity-based core beliefs about vaccines. In between these poles are numerous others who can delay, be reluctant (but still accept), or refuse/accept some vaccines for their children but not others. It is for these vaccine-hesitant parents that constitute the 'middle ground' of this spectrum where the most immediate and productive gains can be made towards enhancing vaccination acceptance and improving uptake. However, navigating this noisy communications environment is difficult, given the array of confusing and conflicting information available from multiple and competing sources. To date, there is no consensus on how best to use communication to respond to vaccine hesitancy. Building on two Canada-wide surveys of parents, the goal of this research is to identify which communication strategies show the greatest impact in reducing parental vaccine hesitancy and improving vaccination intentions.

The specific objectives are to:

1. Develop and pre-test four variations of news media stories that vary by source (parent versus physician) and content (intuitive versus deliberative);
2. Examine the impact of vaccine hesitant parents' exposure to vaccine communications that vary in source (parent versus physician) and content (intuitive versus deliberative) on primary (vaccine hesitant attitudes) and secondary (vaccine intentions) outcomes; and
3. Explore which media story variation may be more effective in improving vaccination attitudes and intentions for different parental decision-making styles (deliberative versus intuitive).


Eligibility Criteria:
Inclusion Criteria:

* Parents over 18 living in Canada with a YOUNGEST child is less than 24 months.

Exclusion Criteria:

* Parents who have a YOUNGEST child older than 24 months
* A parent who is pregnant, before the first trimester is complete
Oral Viscous Budesonide in Anastomotic Stricture After Esophageal Atresia Repair (OVB in EA)

The aim of this study is to perform a multicentre, prospective, randomized, placebo controlled, double-blinded study to demonstrate the potential and beneficial effects of OVB in the prevention of recurrence of anastomotic stricture in children operated for esophageal atresia with an anastomotic stricture.


Eligibility Criteria:
Inclusion Criteria:

* Children aged \> 1 month to 3 years
* Operated for an esophageal atresia of all types except pure TEF.
* Presence of an anastomotic stricture defined according to experts recommendations :

  * a relative esophageal narrowing at the level of the anastomosis,
  * demonstrated by a contrast study and/or an endoscopy
  * with significant functional impairment and associated symptoms requiring dilation.
  * Symptoms include: feeding or swallowing difficulties, coughing and choking during feeds, food impaction, regurgitation/vomiting of undigested food, drooling. In very young patients: apnea and food refusal.
* Receiving an ongoing treatment by PPI 1 to 2 mg/kg die
* Informed parental consent

Exclusion Criteria:

* Known immune deficiency
* Acute respiratory or intestinal infection
* Severe respiratory, cardiac or neurological condition precluding OVB or placebo swallowing
* Child fed exclusively via nasogastric tube or gastrostomy
* Absence of parental consent
Efficacy of Coenzyme q10 in Pediatrics With Type 1 Diabetes Mellitus

The purpose of this study is to determine wether coenzyme Q10 is effective in reducing markers of endothelial dysfunction in pediatric patients with type 1 diabetes mellitus and aslo to investigate its effect on glycemic control and lipid profile of those patients and its effect on patient's quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. Age: patients from 8 to 18 years old.
2. Outpatient with at least 1 year history of type 1 diabetes mellitus.
3. Insulin requirement of more than or equal 0.5 U/Kg/day.
4. Approval to participate and give informed consent.

Exclusion Criteria:

1. Presence of systemic disorders such as celiac disease, hypothyroidism or hyperthyroidism.
2. Preexisting cardiovascular disease or hypertension.
3. Chronic kidney disease or chronic liver disease.
4. Significant mental illness.
5. Intake of other antioxidants such as ascorbic acid and α-tocopherol and omega3 supplement within the last 3 months.
6. Intake of coenzyme Q10 within the last 3 months.