cyrilzakka/clinical-trials huggingface dataset:
ONE-1 Oral graNd Est 1

This study is about the assessment of two oral telemedecine tools compared to an intra oral clinical examination used as a reference among elderly persons living in nursing home. Our hyposthesis is that the diagnostic performance of the two devices will be similar.

The main goal of the study is to assess the performances of two intra-oral cameras compared to an intra oral clinical examination to detect at least one decayed tooth.

The secondary objectives of this study are :

At patient's level:

1. To assess the performances of two intra-oral cameras types compared to an intra oral clinical examination for detecting each of the following conditions: (i) at least one filled tooth, (ii) at least one missing tooth, (iii) gingivitis, (iv) an abscess, (v) dental plaque and (vi) calculous
2. To assess the concordance between each intra oral cameras and the intra oral clinical examination in the evaluation of the number (i) of decayed teeth, (ii) filled teeth and (iii) missing tooth
3. From video acquisitions of each intra oral cameras, to assess the inter-observer concordance for the diagnostic of each dental pathologies (presence of at least one decayed tooth, filled or missing) and periodontal (presence of gingivitis, abscess, dental plaque or scale)
4. From video acquisitions of each intra oral cameras, to assess the inter-observer agreement of the number of teeth: (i) decayed, (ii) filled and (ii) missing

   At tooth level :
5. To assess the performances of two intra-oral cameras types compared to an intra oral clinical examination for detecting each of the following conditions: (i) a cavity, (ii) a filled tooth and (iii) missing tooth

   In all patients :
6. To assess patient's feelings about the use of each intra oral cameras
7. To compare the time required for video acquisitions between each of intra oral cameras

For patients with dental or periodontal pathologies observed during the intra oral examination:

8 To assess, 2 months after initial evaluation, the proportion of patients attended dental or periodontal care and for which an appointment with a dentist has been scheduled


Eligibility Criteria:
Inclusion Criteria:

* Be an adult person
* Be affiliated of granted of health insurance
* Be resident of a nursing home
* People (or the guardian) who received complete information about the research and who signed the consent form.

Exclusion Criteria:

* People deprived of their liberty by justice's decision, or people following psychiatric treatment according to articles L. 3212-1 et L. 3213-1 of the French law
* People with insufficient skills in French
* People with total bimaxillary prosthesis
* People without any teeth
Prediction of Low Birth Weight Infants Using Ultrasound Measurement of Placental Diameter and Thickness

Prediction of Low Birth Weight Infants using Ultrasound Measurement of Placental Diameter and Thickness

The aim of the present study is to assess the value of using ultrasound measurement of placental diameter and thickness as a predictor of low birthweight.

Eligibility Criteria:
Inclusion Criteria:

1. Singleton viable pregnancy.
2. Gestational age at least 36 complete weeks as calculated by LMP.
3. Non scared uterus.

Exclusion Criteria:

1. Multiple fetal pregnancy.
2. Intrauterine fetal death.
3. Known congenital fetal anomalies.
4. Presence of uterine or adnexal gross pathology.
5. Presence of any medical disorder e.g. Diabetes mellitus \& hypertension.
Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery

A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain following bunionectomy surgery.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* Have undergone bunionectomy surgery
* Have achieved adequate post-surgical pain

Exclusion Criteria:

* Confounding medical conditions which preclude study participation
* Participated in a study of another investigational drug or device within 30 days prior to randomization
Does the Use of the GlideRite® Endotracheal Tube in Combination With the I-gel® Improve Intubation Success Rate?

The investigators aim to compare two different types of supraglottic devices for tracheal intubation in patients undergoing elective surgery under general anesthesia.

The investigators hypothesis is that the use of the I-gel® supraglottic airway device associated with a GlideRite® endotracheal tube will result in an equal success rate of fiberoptic tracheal intubation when compared to the LMA-Fastrach® associated with a GlideRite® endotracheal tube. Time to intubate with the I-gel® device should also be shorter.

Supraglottic airway devices such as LMA-Fastrach® and I-gel® provide patent airways during general anesthesia.

The LMA-Fastrach® is designed to provide a conduit for blind or fiberscopically guided tracheal intubations. However, the success rate of tracheal intubation on the first attempt through this device varies between 50 and 87%.

The I-gel® is a newer device for airway management which, with its wide bore, allows direct passage of a tracheal tube. Recent studies suggest that the I-gel® is easy to insert and that limited experience is needed before a high success insertion rate is obtained. A recent study conducted in our center compared the LMA-Fastrach® to the I-gel® supraglottic airway device. Our results showed a lower success intubation rate in the I-gel® group. We noticed that there was a tendency for the endotracheal tube to impinge on the posterior and lateral aspect of the larynx. The endotracheal tube used for intubation in our study was a standard polyvinyl chloride (PVC) tube. We believe that an endotracheal tube with a flexible tip(GlideRite®) would increase the intubation success rate through the I-gel® device. However, based on our clinical experience with the GlideRite® tube, blind tracheal intubation through the I-gel® airway device may be associated with a low success rate related to a lack of rigidity of its tip. Its use in combination with a fibrescope could compensate for this weakness. A recent study performed on mannequins showed a comparable success intubation rate of 99% for the I-gel® and LMA-Fastrach® when associated to a fibrescope.

In this prospective randomized study, we will compare the performance of the LMA-Fastrach® and the I-gel® associated with a GlideRite® endotracheal tube for fiberoptic tracheal intubation in patients undergoing elective surgery under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Patients undergoing elective surgery under general anesthesia, requiring endotracheal intubation

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) classification ≥ 4
* Contraindications to muscle relaxation
* Mouth opening less than 2 cm
* Patients at increased risk of regurgitation
Modulation of GABA-A Receptors in Parkinson Disease-Flumazenil Arm

This arm is a positron emission tomography (PET) biomechanistic GABA-A receptor target engagement study that includes detailed clinical and motor assessments before and after the i.v. administration of 1 mg flumazenil or placebo in Parkinson disease subjects. Each subject will receive 1mg flumazenil or placebo at two visits.

This biomechanistic GABA-A receptor target engagement study includes clinical and motor assessments before and at various time points up to approximately 90 minutes after the i.v. administration of 1 mg flumazenil and placebo in Parkinson disease subjects. Thirty Parkinson disease subjects with disease severity (Hoehn and Yahr) stages 2-4 will be recruited. Baseline \[11C\]FMZ and vesicular monoamine transporter type 2 (VMAT2) \[11C\]DTBZ brain PET imaging will be performed prior to drug administration to assess for GABA-A receptor availability and the integrity of nigrostriatal dopaminergic nerve terminals, respectively.

Eligibility Criteria:
Inclusion Criteria:

1. Parkinson's disease (PD): PD diagnosis will follow the UK Parkinson's Disease Society Brain Bank Research Center (UKPDSBRC) clinical diagnostic criteria for PD.
2. Hoehn and Yahr stages 2-4
3. Absence of dementia confirmed by cognitive testing.
4. Abnormal 11C-Dihydrotetrabenazine (\[11C\]-DTBZ) PET study to demonstrate nigrostriatal dopaminergic denervation.

Exclusion Criteria:

1. PD with Dementia (PDD) or dementia with Lewy bodies (DLB).
2. Other disorders which may resemble PD, such as vascular dementia, normal pressure hydrocephalus, multiple system atrophy, corticobasal ganglionic degeneration, or toxic causes of parkinsonism. Prototypical cases have distinctive clinical profiles, like early and severe dysautonomia or appendicular apraxia, which may differentiate them from idiopathic PD. The use of the UKPDSBRC clinical diagnostic criteria for PD will mitigate the inclusion of subjects with atypical parkinsonism.
3. Subjects on benzodiazepine, GABA-ergic medications (baclofen, tizanidine), neuroleptic, anticholinergic (trihexyphenidyl, benztropine), or cholinesterase inhibitor drugs.
4. Evidence of a mass lesion on structural brain imaging (MRI).
5. Participants in whom MRI is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, chest, or cochlear implant.
6. Severe claustrophobia precluding MR or PET imaging.
7. Subjects limited by participation in research procedures involving ionizing radiation.
8. Pregnancy (urine or serum pregnancy test within 48 hours of each PET session) or breastfeeding.
9. History of seizures
10. Significant anxiety or history of panic disorder.
11. History of recent suicide attempt or overdose of tricyclic antidepressants or other medications
12. Any other medical history determined by investigators to preclude safe participation.
13. Allergy to flumazenil
14. Significant liver disease
15. History of alcohol or other substance abuse within past two years.
16. History of regular benzodiazepine use within past year
The Fluoroless-CSP Trial Using Electroanatomic Mapping

The goal of this study is to assess the feasibility, accuracy and safety of performing fluoroless (or low fluoro) conduction system pacing utilizing electro-anatomic mapping (EAM) with the CARTO 3 mapping system (Biosense Webster Inc, Irvine, CA) in comparison to a group of patients undergoing conventional conduction system pacing (CSP) Implants.

The goal of this study is to assess the feasibility, accuracy and safety of performing fluoroless (or low fluoro) conduction system pacing utilizing electro-anatomic mapping (EAM) with the CARTO 3 mapping system (Biosense Webster Inc, Irvine, CA) in comparison to a group of patients undergoing conventional conduction system pacing (CSP) Implants.

In this study, we plan to randomize patients to fluoroscopy guided CSP vs 3D mapping guided CSP implants with low/zero fluoroscopy. The study with assess if 3D EAM guided implants can be performed successfully and without any significant increase in device implant related complications.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Indication for Permanent Pacemaker implantation or implantation of Cardiac Resynchronization Therapy Device

Exclusion Criteria:

* Existing cardiac device including Pacemaker or Cardiac Resynchronization Therapy device
* Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity
* Pregnancy
* Difficulty with follow-up
Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer

The main purpose of this study is to learn whether or not the combination of gemcitabine, bevacizumab and erlotinib works in treating patients with advanced or metastatic pancreatic cancer. Bevacizumab is a new anti-cancer drug. It is an antibody that works to slow or stop cell growth in cancerous tumors by decreasing the blood supply to the tumors. It is approved by the FDA for the treatment of colorectal cancer but is still considered investigational for treating pancreatic cancer.

* Participants will receive study treatment as an outpatient. The study treatment will be given in time periods called cycles. Each treatment cycle will be 28 days.
* Gemcitabine will be given intravenously on days 1, 8, and 15 (once per week for the first three weeks) of the treatment cycle.
* Bevacizumab will be given intravenously on days 1 and 15 (once every 2 weeks) of the treatment cycle.
* Erlotinib will be taken orally every day of the treatment cycle.
* Participants will see the doctor or nurse practitioner every week for the first 28 days of treatment. During all of the following cycles, they will see the doctor or nurse practitioner on day 1 and day 15 of each cycle.
* Each 4-week cycle can be repeated until the participant or the doctor decided that they should be removed from the study.

Eligibility Criteria:
Inclusion Criteria:

* Previously untreated patients with unresectable or metastatic adenocarcinoma of the pancreas
* ECOG Performance Status 0-2
* 18 years of age or older
* Radiographically measurable disease
* Expected survival of at least 4 months
* Creatinine of \</= 2.0
* Adequate hepatic function
* Adequate hematopoietic function
* Use of effective means of contraception in subjects of child-bearing potential

Exclusion Criteria:

* Warfarin anticoagulation
* Prior treatment with a tyrosine kinase inhibitor, EGFR inhibitor, or VEGF inhibitor
* Coexistent malignant disease
* Current or recent (within 4 weeks) participation in a clinical trial
* Pregnancy
* Documented invasion of adjacent organs or major blood vessels
* Blood pressure of \> 150/100mmHg
* Unstable angina
* NYHA Grade II or greater congestive heart failure
* History of myocardial infarction or stroke within 6 months
* Clinically significant peripheral vascular disease
* Evidence of bleeding diathesis of coagulopathy
* Presence of CNS or brain metastases
* Major surgical procedure, open biopsy, or significant traumatic event within 28 days
* Minor surgical procedures, fine needle aspirations or core biopsies within 7 days
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months
* Serious non-healing wound, ulcer or bone fracture
Efficacy of Totalfill® and ProRoot MTA® as Pulpotomy Agent in Primary Molars

An experimental prospective double-blind, randomized clinical trial (RCT) with parallel design. To evaluate the outcome of using 2 pulpotomy agents: Totalfill® as study group and mineral trioxide aggregate (MTA®) as a control.

When a tooth decay is too deep and extended into the tooth pulp, then the tooth is not indicated to be treated with a filling. Therefore, removing the diseased pulp and then cover the rest with a suitable material is required. The Purpose of this study is to check the success of pulp treatment on deciduous molars with deep caries using 2 pulp treatment agents: (Totalfill® and MTA®). The use between the materials is randomly assigned. However, the use of the materials has no side effect or complications as it is a routine dental procedure.

The participants are healthy children aged between 3 and 9 years old, and the study is taking place in Ghent University Hospital, Ghent, Belgium, and it is planned to be conducted in duration of 4 years, which include 20 months for participants recruitment.

After placing the material, the tooth is restored with stainless steel crowns, and the participant was asked for follow up to check the tooth and to take dental x-ray every 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patient inclusion criteria

   * ASA 1 patient, Patient is a completely healthy \& fit. No allergy or medical conditions.
   * Patient is indicated for treatment under General Anesthesia: young age, uncooperative and extensive treatment plan.
   * Parent agreed to participate in the study, and signed the written consent.
   * Patient attended the out-patients pediatric dental clinic in UZ Gent.
2. Tooth inclusion criteria 2.1. Clinical inclusion criteria:

   * Vital primary molars (first or second) with deep caries cavity with pulpal exposure.
   * Only mandibular primary molar were included
   * No spontaneous pain
   * No history of swelling
   * No sinus tract/ fistula
   * Absent of tenderness in percussion
   * No pathological mobility
   * Restorable tooth (stainless steel crown can be placed)
   * Hemostasis can be achieved with a dry cotton pellet after removal of Coronal pulp.

2.2. Radiographical inclusion criteria:

* At least 2/3rd of root is present
* Absence of internal or external root resorption
* Absence of pathologic root resorption
* Absence of periapical or furcation radiolucency

Exclusion Criteria:

If one or more of the criteria mentioned above is not fulfilled, the teeth were excluded from the study.
Treatment of Venous Malformation

Vascular malformations are birth defects that happen when different stages of angiogenesis shut down. 44 - 64% of all vascular malformations are venous malformations (VMs). Sclerotherapy is the first treatment line for VMs. It acts by getting rid of the vascular endothelial cells in the lesion. One of the most common and well researched sclerosing agents for VMs is polidocanol, which is a popular counterpart for concentrated ethanol.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with venous malformation of both genders and age above one year.

Exclusion Criteria:

* Age below one year.
* Patients had any other vascular malformations.
* Indication for contrast material or Alcohol and polidocanol injection.
* Unfit for general anesthesia. 5) Pregnancy. 6) Skin infection, inflammation, and ulcers.
* Pulmonary embolism.
* Acute Ischemia, and acute DVT.
Renin Levels as Prognostic Indicators of Septic Shock Severity and Outcome

The Surviving Sepsis Campaign (SSC) of 2021 characterizes sepsis as a life-threatening organ dysfunction caused by a dysregulated host response to infection, with a mortality rate of over 30%, which increases to 40% or more in the case of septic shock. Although concept of sepsis has improved, significant gaps remain in assessing its clinical severity and predicting patient outcomes.

Recognized markers of the severity of septic shock are procalcitonin (PCT), presepsin, and, to a certain extent, lactate. Elevated lactate levels result from a shift to anaerobic glycolysis and indicate inadequate oxygen delivery to tissues. Despite the importance of procalcitonin in the course of sepsis, it has proven to be a suboptimal diagnostic biomarker for the development of sepsis, with sensitivity and specificity below 80%. As a result, the use of procalcitonin in addition to clinical assessment to determine the indications for initiating antibiotic therapy is not recommended. Meanwhile, presepsin, although a potential biomarker for the early diagnosis of sepsis, also has only moderate accuracy according to current data and cannot be used as the only test for the diagnosis of sepsis.

Renin is a crucial enzyme in the renin-angiotensin-aldosterone system (RAAS), which plays an important role in the regulation of blood pressure, tissue perfusion, and the balance of water and electrolytes. Thus, renin may be the sensitive biomarker with good prognostic qualities in the context of sepsis and septic shock. Preliminary studies have indicated that elevated renin levels may act as an indicator of patient severity, and could also be used as a marker for the development of septic shock and mortality prognosis.

This study aims to address these gaps by investigating the role of renin as a biomarker for the severity of sepsis and septic shock, focusing on its potential for more accurate prediction of clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Hospitalization in the intensive care unit
* Confirmed diagnosis of Sepsis within 24 hours
* Signed informed consent or a decision by the medical council to include the patient in the study

Exclusion Criteria:

* Any surgical intervention on the kidneys and/or adrenal glands performed within 28 days prior to the patient's inclusion in the study
* Patients previously included in this study
Written vs Electronic Safety Planning Study

Safety planning is a brief, ED-feasible intervention which has been demonstrated to save lives and has been universally recommended by every recent expert consensus panel on suicide prevention strategies. In one popular version of the safety plan developed by Stanley et al, the patient is encouraged to write out the following items: identifying personal signs of a crisis; helpful internal coping strategies; social contacts or settings which may distract from a crisis; using family members or friends for help when in crisis; mental health professionals who can be contacted when in crisis; and restricting access to lethal means.

This study aims to find out how valuable an electronic safety plan is compared to a traditional paper safety plan. People who are visiting the emergency department for thoughts of self-harm will be asked to participate.

This project has 3 aims: (1) Will ED patients with suicidal ideation/attempt accept coaching on safety planning from non-clinical personnel (i.e., medical students or peer supporters); (2) Are these safety plans of high-enough quality for clinical personnel; and finally, (3) Will ED patients with suicidal ideation/attempt complete safety plans electronically?

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for suicidal ideation (SI) or after a suicide attempt to the UAMS ED
* Willingness to engage in safety planning with trained non-clinical staff
* Have not already filled out a safety plan at the current visit

Exclusion Criteria:

* \<18 or \>89 years of age
* Incarcerated or in police custody
* Non-English-speaking or Non-English-writing (as translators will not be available for this study)
* Critically-ill (or appear to be critically-ill)
* Intoxicated with alcohol or other substance(s)
* ED staff objection to patient enrollment in study
* Unwilling or unable to complete the safety plan electronically
* Unwilling or unable to use a tablet device to complete the safety plan
* Unwilling or unable to show/email the safety plan to clinical and research staff