cyrilzakka/clinical-trials huggingface dataset:
Validity of Radical 7 Masimo Monitor at Measuring Hemoglobin in Pediatric Cardiac Intensive Care

Fifty percent of children that survive a critical illness are anemic at discharge from the pediatric intensive care unit (PICU)(1). Given that there are approximately 9000 PICU admissions/year in Canada, this represents almost 4500 children per year. Anemia is associated with abnormal neurocognitive development in infants and young children. A contributor to PICU anemia is the excessive amount of blood testing and iatrogenic blood losses(2). Non-invasive continuous hemoglobin monitoring (Sp-Hb) have been developed in the medical setting in an attempt to minimize invasive blood testing and reduce blood losses. The Radical 7 Masimo device (Masimo corporation, Irvine, CA) is one of the popular devices used for non-invasive hemoglobin monitoring. Its accuracy has been previously investigated in various populations(3-6). The objective of this study is to investigate the validity of the Radical 7 Masimo device at measuring hemoglobin trends non-invasively in critically ill children.

This will be a prospective observational study. We will include 1) all patients that are admitted to the PICU of the CHUSJ after a cardiac surgery, 2) that are aged less than 6 months on the day of admission and that 3) have an arterial line inserted.

All children studied will have an arterial line inserted at the time of surgery that will allow for arterial-Hb measurements. As this study is strictly observational, all arterial-Hb measurements will be requested by the medical treating team as clinically indicated. We will install, on admission, the spectrophotometric adhesive sensor required for Sp-Hb measurements on each patient (Masimo Rainbow R1 20 for children over 30 kg and R1 20L for those under 30 kg). The sensor will be applied on the hand or foot that does not have an arterial cannula. The sensor will be covered with an impermeable black shield to prevent optical interference.

We will collect all the arterial-Hb measurements performed in the 48 hours after PICU admission as well as all the Sp-Hb readings performed at the time of the arterial samples. The blood samples drawn from the arterial catheter will be analyzed using a laboratory CO-oximeter (model ABL820; Radiometer, Copenhagen, Denmark). Simultaneous recording of Sp-Hb will performed within 10 seconds after the arterial blood sample is drawn. We will also collect demographic data and clinical data on each patient; age, weight, sex, ethnicity, type of cardiac surgery, blood transfusions. At the CHUSJ PICU, all clinical and demographic data is systematically recorded in our electronic database (Intellispace Critical Care and Anesthesia, Philips Medical Systems). Data on red cell transfusions are recorded through the TracelineTM database that is made available to our research group through Héma-Québec. Data will be extracted from our database by our research assistant.

Eligibility Criteria:
Inclusion Criteria:

* 1) patients that are admitted to the PICU of the CHUSJ after a cardiac surgery, 2) that are aged less than 6 months on the day of admission and that 3) have an arterial line inserted.
Intentional Pulpotomy to Preserve Hopeless Molars

When proximal carious lesions of primary molars are located in close proximity to the cementum enamel junction (CEJ), marginal seal is challenging and extraction is recommended. Pulpotomy is indicated for vital primary teeth to preserve them in function. The goal of this study is to monitor the long-term effect of intentional bioactive cement pulpotomies and crown coverage performed on vital and asymptomatic carious primary molars with gingival margins close to or at the CEJ


Eligibility Criteria:
Inclusion Criteria:

* Selected patients will have one or more primary molar teeth diagnosed clinically with large proximal carious lesions with the gingival extension of the cavity at or below the cemento-enamel junction. The tooth should be asymptomatic and must have no signs of swelling, fistula, abnormal mobility and sensitivity to percussion (ruling out food impaction), and adequate space for placement of a stainless steel crown restoration. The pre-operative periapical radiograph, taken as part of the new patient/recall routine visit, should reveal a lesion in close approximation to the pulp, but having at least 1-2 mm of sound dentin separating the deepest portion of the lesion and the pulp. In addition, no evidence of furcation and periapical pathology, internal or external root resorption and presence of half to two-thirds of root length remaining.

Exclusion Criteria:

* Uncooperative patients
* Teeth with positive history of pain, abnormal mobility, signs of pulp necrosis such as presence of swelling or fistula, and significant space loss due to caries not allowing placement of a stainless steel crown restoration
* Radiographically, signs of furcation and periapical pathology, internal and external resorption, less than half to 2/3 of root length remaining
* Selected patients will be treated by pediatric dental residents in the regular dental clinic setting with or without nitrous oxide inhalation, as part of the standard of care
* Prior to the beginning of the study, all operators will be calibrated by the principal investigator on identifying the teeth in question, as well as on the restorative technique
* Selected patients may have one or more qualified teeth
Clinical Assessement of Glazed Versus Polished Lithium Disilicate Crowns in Surface Roughness and Enamel Antagonists Wear

It is believed that final glazing yields the most acceptable ceramic surfaces in terms of smoothness. However, since reglazing must be performed in a dental laboratory with the use of a thermal furnace, it requires multiple office visits. Repeated firings have a destructive effect on ceramic surfaces and can cause deformation. Conversely, polishing is easy and simple and can be accomplished in a single session.


Eligibility Criteria:
Inclusion Criteria:

* Patients from 18-50 years old who are able to read and sign the informed consent document.
* Physically and psychologically able to tolerate conventional restorative procedures.
* Have no active periodontal or pulpal diseases, have teeth with good restorations.
* Patients have no temporomandibular disorders.
* Each participant needed a crown on either a first or second premolar or first or second molar in any arch.
* Teeth selected shoud include:

restorability with a crown:root ratio of at least 1:1. presence of an opposing natural tooth which was non-restored or minimally restored.

the presence of two non-restored or minimally restored teeth opposing each other on the same quadrants as the crowned tooth and the opposing to serve as enamel controls. Minimally restored was defined as teeth which have no restoration greater than a Class II amalgam restoration.

- Willing to return for follow-up examinations and evaluation.

Exclusion criteria

* Patients in the growth stage with partially erupted teeth.
* Patients with poor oral hygiene and motivation.
* Pregnant women.
* Psychiatric problems or unrealistic expectations.
* Lack of opposite occluding dentition in the area intended for restoration.
* Patients with temporomandibular disorders.
Remineralization Effect of Fluoride Varnishes on Permanent Molars

The aim of this study was to evaluate and compare the efficacy of NaF, NaF with TCP, NaF with CPP-ACP, and NaF with CXP varnishes on newly erupted first permanent molar teeth. The study was carried out in 40 healthy, high caries risk children (DMFS \>8), aged six to seven years with newly erupted permanent first molars who referred to the Pediatric Dentistry Clinic of Kırıkkale University Faculty of Dentistry, Kırıkkale, Turkey. A total of 140 teeth were divided randomly into four groups and the varnishes were applied to the determined teeth at baseline, one and three months. The same varnish was used, if there is more than one first molar to be applied of the same patient. The groups were comprised as follows:

Group 1: Duraphat Varnish containing 5% NaF (Colgate-Palmolive, NSW, Australia) (n = 35), Group 2: Clinpro™ White Varnish containing 5% NaF with TCP (3M ESPE, MN, USA) (n = 35), Group 3: Embrace ™ Varnish containing 5% NaF with CXP (Pulpdent, MA, USA) (n = 35), Group 4: MI Varnish containing 5% NaF with CPP-ACP (GC, Tokyo, Japan) (n = 35). All dental treatments of the patients were completed before the varnish application and oral hygiene instructions were given to all children at the start of the study.

Patients were called for follow up appointments at 1, 3 and 6 months, and in the follow-up period DIAGNOdent device (laser fluorescence scanning) was used to monitor mineralization changes. LF measurements were made at baseline (T0), after one month (T1) three months (T2) and six months (T3). Within and between group comparisons were analysed statistically.


Eligibility Criteria:
Inclusion Criteria:

Subject has at least one fully erupted permanent first molar tooth

Exclusion Criteria:

Subject has a permanent first molar tooth with visible cavitation on the tooth surface Subject has a partially erupted permanent first molar tooth.
Comparative Effectiveness of Neuroprotectants on Acute Ischemic Stroke

The primary objective of this study is to compare effectiveness of five different neuroprotectants, including butylphthalide, edaravone, citicoline, cerebrolysin, and piracetam, among patients with acute ischemic stroke.

The secondary objectives of the study are as follows:

* To compare safety of five different neuroprotectents, including butylphthalide, edaravone, citicoline, cerebrolysin, and piracetam, among patients with acute ischemic stroke.
* To compare cost-effectiveness of five different neuroprotectents, including butylphthalide, edaravone, citicoline, cerebrolysin, and piracetam, among patients with acute ischemic stroke.

Study Population:The study population will consist of consenting patients who are on neuroprotectant injection for the treatment of acute IS during hospitalization. Hospitals may contribute differing numbers of patients to the total sample size. Primary analyses will be conducted on the total sample size only.

Assessment of Outcomes:The outcome measures in this study include effectiveness, safety and cost measures.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Ischemic stroke confirmed by brain CT or MRI within 14 days of the index event
* Neuroprotectents administrated during hospitalization
* Direct admission based on physician evaluation or arrival through the emergency department
* Ability of patient or legally authorized representative (primarily spouse, parents, adult children, otherwise indicated) to provide informed consent.
Efficacy of Formulated Posterior Sub Tenon Triamcinolone in Macular Edema Secondary to Non-Ischemic Retinal Vein Occlusions

Retinal vein occlusion (RVO) is considered the second vascular disorder of the retina after diabetic retinopathy. Patients with RVO are at risk of the development of macular edema. Different treatment modalities for macular edema include LASER therapy, antivascular endothelial growth factor (VEGF), and triamcinolone.

Aim To detect the efficacy of formulated Triamcinolone Acetonide(TA) injection in the posterior subtenon space to manage macular edema secondary to non-ischemic RVOs, either central or branch.


Eligibility Criteria:
Inclusion Criteria:

* Diminution of vision due to macular edema secondary to non-ischemic retinal vein occlusions, either central or branch
* CMT ≥ 250 µ,
* Willing to participate in the study.

Exclusion Criteria:

* Unwilling to participate in the study
* Ischemic RVO
* previous laser treatment
* Glaucoma, macular ischemia, cataract, vitreous hemorrhage, and neovascularization of the iris
* patients with previous anti VEGFs or steroid injections or any eye surgery three months before the inclusion
* Cardiac co-morbidities result in significant hemodynamic changes
* Respiratory diseases need treatment with antibiotics
* Suffering from other chronic diseases as diabetes
* Patient with allergy from triamcinolone acetonide.
Transarterial Radioembolisation in Comparison to Transarterial Chemoembolisation in Uveal Melanoma Liver Metastasis

Characterisation of effect of SIRT and DSM-TACE as local treatment options for liver metastases in patients with advanced uveal melanoma with respect to progression-free survival and exploratory comparison of secondary endpoints regarding application, activity, adverse effects and impact on quality of life in a randomized study design.

This is a randomized phase II trial to evaluate the effect of transarterial radioembolisation with yttrium-90 microspheres (SIRT) and transarterial chemoembolisation with cisplatin (DSM-TACE) in patients with liver metastases due to advanced uveal melanoma in terms of progression-free survival and multiple secondary endpoints.

Patients in study arm A will receive transarterial radioembolisation one time only. Patients in study arm B will receive transarterial chemoembolisation every 4 to 6 weeks until complete tumor devascularisation is observed or disease progression or intolerable toxicity occur. At the time of local tumor progression patients will be offered the other treatment respectively (either SIRT or DSM-TACE) as part of the study.

Eligibility Criteria:
Inclusion Criteria (main):

* ECOG Performance Status of 0, 1 or 2
* Histologically or cytologically confirmed liver metastases of uveal melanoma
* At least one measurable lesion according to RECIST criteria v1.1 determined MRI (if contraindications against MRI exist CT with contrast media can is allowed)
* Metastases in other sides are allowed if not in need of treatment (e.g. asymptomatic bone metastasis without indication for radiation)
* Prior treatment with systemic anti-cancer therapy is allowed if terminated ≥ 4 weeks prior to study treatment start and recovery from toxicity is achieved
* Surgery in general and hepatic surgery in particular (e.g. lobe resection, radiofrequency ablation) prior to study enrollment are allowed if realized ≥ 4 weeks prior to study enrollment and recovery from surgery is achieved

Exclusion Criteria (main):

* Surgically treatable liver metastases
* Previous intraarterial hepatic treatment (e.g. radioembolisation, chemoembolisation, intraarterial chemotherapy, isolated or percutaneous hepatic perfusion)
* Previous treatment with external liver radiation
* Major intrahepatic occlusion of the portal vein and/or tumor infiltration of the portal vein
* Liver cirrhosis Child-Pugh C
* Progressive liver failure
* Renale failure, bone marrow insufficiency, coagulopathy
* Uncontrolled or severe medical conditions which could impair the ability to participate in the trial such as unstable cardiac disease or uncontrolled infection
* Other malignancy and/or metastases in need of treatment
* Current treatment with any anti-cancer therapy
Endotracheal Tube Obstruction in Covid-19 Patients Requiring Mechanical Ventilation

The COVID-19 pandemic is very present in our region, the Grand-Est region is considered as one of the first COVID-19 epicentres in France. COVID-19 causes an acute respiratory distress syndrome requiring prolonged mechanical ventilation in resuscitation.


Eligibility Criteria:
Inclusion Criteria:

* Major Subject (≥18 years)
* Subject with COVID 19 (radiological suspicion or microbiological confirmation)
* Subject hospitalised in the intensive care unit at the NHC of the University Hospitals of Strasbourg between 01/03/2020 and 03/04/2020.
* Subject treated by mechanical ventilation
* Subject who has not expressed his opposition, after information, to the re-use of his data for the purposes of this research

Translated with www.DeepL.com/Translator (free version)

Exclusion Criteria:

* Subject who expressed opposition to participating in the study
* Subject under guardianship, curatorship or safeguarding of justice
Investigation of Biofilm Formation on Temporary push-on Rings of Implant Crowns

This in-vivo study investigates early (48h), mature (2 weeks) and long-term (3 months) biofilm formation and composition on temporary push-on cones (exchangeable conical rings) made of noble-alloy-based materials (Pagalinor, PA) in comparison to Titanium-6Aluminum-7Niobium alloy (TAN) presently used in the transmucosal portion of dental implant abutments.

Oral biofilm (dental plaque) consists of bacteria and their metabolic products as well as saliva components and food residues. It is recognizable as a tough and structured coating on teeth and artificial surfaces within the oral cavity. Plaque development is a physiological process that begins immediately after cleaning of the oral surface. If the biofilm is not removed by daily oral hygiene, it continues to mature while changing the structure and its microbial composition.

Implant restorations comprise the osseous implant portion predominantly manufactured from titanium alloys, the transmucosal implant portion (in most implant systems as a separate abutment), and the clinical crown, which is in most systems extraorally cemented on an abutment and screw-retained onto the implant. According to current knowledge, microbial colonization of the implant abutment surface plays a significant role in the aetiology of peri-implantitis.

This study investigates the antibacterial potential of a temporary push-on cone (conical ring) that could reduce the risk of bacterial related peri-implant diseases due to decreased biofilm susceptibility, compared to current available transmucosal materials, in the short- and long-run. The test material Pagalinor®2 (PA) is an established material in dental medicine and has proven to accumulate least biofilm in an in-vivo biofilm sampling model using removable splints. The control material consists of the current transmucosal implant abutment material Titanium-6Aluminum- 7Niobium alloy (TAN). The push-on rings are designed for repeated application along the transmucosal implant abutment portion with high precision fit and will allow biofilm sampling in the natural implant environment. Profound insight into the native homeostasis of biofilm formation will be obtained and therefore enhance the knowledge about long-term tissue response.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent signed by the subject
* Presence of one or more bone level titanium implant prior to insertion of the final restoration
* No systemic illness
* No heavy smoking (smoking \<10 cigarettes/day)
* No pregnancy
* No active periodontitis (probing pocket depth ≤4 mm)
* No pharmacological treatment or antibiotic therapy during or up to three months before the study

Exclusion Criteria:

* Systemic illness (e.g. Diabetes)
* Heavy smoking (smoking \>10 cigarettes/day)
* Known or suspected non-compliance, drug or alcohol abuse
* Pregnancy
* Active periodontitis (probing pocket depth \>4 mm)
* Pharmacological treatment or antibiotic therapy during or up to three months before the study
Metastatic Colorectal Cancer Liver Metastases Outcomes After Resin 90Y Microsphere Radioembolization in the USA Evaluation Project

Investigator initiated multi-institutional retrospective review of clinical and radiographic outcomes after 90Y resin microsphere radioembolization for metastatic colorectal liver metastases in the USA. The target is for at least 1,000 evaluable patients with 12+ weeks follow up.

Investigator initiated multi-institutional retrospective review of clinical and radiographic outcomes after 90Y resin microsphere radioembolization for metastatic colorectal liver metastases in the USA. The target is for at least 1,000 evaluable patients with 12+ weeks follow up. Objectives:

Independent data collection and reporting of pre treatment and 12 week post treatment clinical, radiographic and radiation parameters and outcomes in patients treated in the USA from 2002-2010. Data beyond 12 weeks will be collected and highly desirable, however as a minimum all patients will have 12 week follow up.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received 90Y resin microsphere radioembolization for metastatic colorectal cancer with liver metastases between November 2010 and March 2011 in the USA. Patients must have at least 12 weeks of follow up.

Exclusion Criteria:

* Patients who received glass 90Y microsphere radioembolization for metastatic colorectal liver metastases.
A Multi-Center, Open Label, Extension Study Assessing the Efficacy and Safety of Additional Intravitreal Injections of RBM-007 in Subjects With Wet Age-related Macular Degeneration

This is a multi-center, open label, extension study of NCT04200248 assessing the efficacy and safety of additional intravitreal injections of RBM-007 in subjects with wet age-related macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

1. Provide signed written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.
2. Male or female 55 years of age or older on the date of signing the ICF and able and willing to comply with all treatment and study procedures.
3. Subjects must have completed all scheduled visits of previous study. Subjects can only enter this study after exiting previous study
4. Subjects for which previous previous masked treatment arms with intravitreal anti-vascular endothelial growth factor (anti-VEGF) agents Eylea® and/or RBM-007 has not demonstrated improvement in vision; subjects with less than 15 letter Best Corrected Visual Acuity (BCVA) improvement in TOFU study at exit visit over its baseline.
5. Diagnosis of exudative age-related macular degeneration (AMD) in the study eye, as assessed by spectral domain optical coherence tomography (SD-OCT).
6. Absence of central atrophy or retinal epithelial tear in the fovea or any condition preventing VA improvement in the study eye.
7. BCVA of 24 ETDRS letters (20/320) or better in the fellow eye.
8. Reasonably clear media and some fixation in the study eye to allow for good quality SD-OCT and fundus photography.

Exclusion Criteria:

* 1. Subjects whose vision have improved \>15 BCVA letters at exit visit of previous study over its baseline 2. Subjects who experienced any drug related serious adverse event during previous study