cyrilzakka/clinical-trials huggingface dataset:
The Effect of Different Methods of Airway Management on the Stomatognathic System: an Observational Prospective Study.

The manipulations required during airway management and the different methods of establishing an airway (endotracheal intubation, supraglottic airway device etc) during anesthesia, as well as certain drugs used during anesthesia and sedation, may have an impact to the stomatognathic system. These effects can vary from a subtle temporomandibular joint disc displacement with reduction to the onset of temporomandibular disorders to previously healthy subjects.This observational prospective study aims at investigating the effect of different methods of airway management during anesthesia on the stomatognathic system (including temporomandibular joint, mastication muscles, occlusion etc).

After being informed about the study, all patients giving written informed consent will undergo elective abdominal surgery or elective gynecological surgery (both open or laparoscopic surgeries), under general or regional anesthesia. Participants will be assigned to groups, depending on the method of airway management during anesthesia (endotracheal intubation, supraglottic airway device, sontaneous breathing).

Clinical examination of the stomatognathic system will be performed preoperatively and postoperatively (24 hours after surgery) and data concerning signs and symptoms associated with the development of temporomandibular disorders will be recorded. A follow-up questionnaire will be administered by telephone 30 days after surgery in order to record data concerning the stomatognathic system and mandibular function.

Parameters related to the physiology of the stomatognathic system, parameters related to the airway management technique, patient position, parameters related to postoperative recovery, as well as postoperative analgesic consumption will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* 18-70 years old
* ASA I-III
* elective abdominal surgery or elective gynecological surgery
* general or regional anesthesia

Exclusion Criteria:

* edentulous patients
* ear disease
* history of head and/or neck cancer
* head and neck surgery, surgery that is known to affect temporomandibular joints
* nose and/or skull base fractures
* history of dystonia/musculoskeletal disease that require treatment with muscle relaxant drugs
* cognitive impairment
* ASA \> 3
* patients which underwent over 3 attempts of airway establishment during airway management
* change of anesthesia plan during surgery
* patient refusal to participate
* inability to comprehend Greek or English
* patient participation in another research project during the previous 30 days
Add-on Therapy With Low Dose Fenfluramine in Lennox Gastaut Epilepsy

In this trial, the potential anti-epileptic effect of low dose fenfluramine in Lennox Gastaut epilepsy will be studied. An exploratory dose finding add-on trial is proposed. At baseline and at the end of the study, ECG and ultrasound of the heart will be performed as part of the safety follow up.


Eligibility Criteria:
Inclusion criteria

Electro-clinical epilepsy syndrome compatible with Lennox Gastaut syndrome:

* Minimum requirements (based on ILAE epilepsydiagnosis.org):

  * Multiple seizure types including in any case tonic seizures
  * EEG shows slow spike waves and abnormal background
  * Abnormal cognitive development
  * MRI compatible with Lennox Gastaut epilepsy : no progressive disease
* Drug resistant:

  * at least 4 documented seizures in the last 4 weeks before inclusion (minimum 4 seizures in at least 2 separate weeks) Seizure types eligible for inclusion are : generalized tonic-clonic seizures GTC , tonic seizures TS , atonic seizures AS or clearly recognizable focal seizures FS.
  * on \>= 2 AEDs (including VNS) during the 4 weeks before inclusion (no changes in treatment before inclusion and during the trial)
* Age between 3 and 18 years
* Subject is male or non-pregnant, non-lactating female. Female subjects of childbearing potential must not be pregnant or breast-feeding. Female subjects of childbearing potential must have a negative urine pregnancy test. Subjects of childbearing or child-fathering potential must be willing to use medically acceptable forms of birth control, which includes abstinence, while being treated on this study and for 90 days after the last dose of study drug.

Exclusion Criteria

* Known clinical cardiovascular abnormalities (including valvular problems, shunts, pulmonary hypertension, exercise intolerance)
* Any cardiac ultrasound/ECG abnormalities at baseline
* Weight below percentile 3 for age at baseline
* Subject is receiving concomitant therapy with: centrally-acting anorectic agents; monoamine oxidase inhibitors; any centrally-acting compound with clinically appreciable amount of serotonin agonist or antagonist properties, including serotonin reuptake inhibition; atomoxetine, or other centrally-acting noradrenergic agonist; cyproheptadine, and/or cytochrome P450 (CYP) 2D6/3A4/2B6 inhibitors/substrates.
* Subject is unwilling to refrain from large or daily servings of grapefruits and/or Seville oranges, and their juices beginning with the Baseline Period and throughout the study.
The Patient Characteristics and Mortality of Code Blue Calls

This study aimed to retrospectively examine patients evaluated by the Code Blue team on a Code Blue call in our hospital between 2009 and 2013.

Primary outcome: an examination of the survival rates and demographic data of the patients evaluated as an emergency by a Code Blue call in the period 2009-2013.Secondary outcome: to determine the rates of false Code Blue calls, the clinics giving Code Blue calls and the relationship between the times of Code Blue calls and mortality.Inclusion criteria: patients throughout the whole hospital for whom a Code Blue form was completed and who were evaluated by the Code Blue team on a Code Blue call.

Exclusion criteria: patients who refused treatment

Retrospective examination was made of the Code Blue notification forms which were completed by the anaesthesiologist as Code Blue team leader of the hospital. The age of the patient, gender, diagnosis, the department where admitted, time of Blue Code call, reason for Blue Code call, whether or not the Blue code call was appropriate, whether or not cardiopulmonary resuscitation was administered, if administered, the duration of cardiopulmonary resuscitation, whether or not the patient was postoperative, whether or not the patient had been discharged from the intensive care unit and if so, how many days had passed, the APACHE II score of the patient and expected mortality, were recorded by calculation of the data on thhe Code Blue notification form and in the hospital automated system. Patients were excluded from the study if they had refused treatment or if there was no record of the parameters necessary to calculate the APACHE II score.

Eligibility Criteria:
Inclusion Criteria:

Patients throughout the whole hospital for whom a Code Blue form was completed and who were evaluated by the Code Blue team on a Code Blue call.

Exclusion Criteria:

Patients who refused treatment

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Recurrence Rate After Endoscopic Resection of , Laterally Spreading Tumor Granular Type (LST-G) of the Colon and Rectum: Endoscopic Mucosal Resection Vs. Endoscopic Submucosal Dissection

Colorectal cancer is one of the leading causes of cancer-related mortality worldwide. Early-stage non-polypoid neoplastic lesions, particularly Laterally Spreading Tumors - Granular Type (LST-G) larger than 20mm, require effective endoscopic removal to prevent malignant progression. The two primary techniques for resecting these lesions are Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD).

EMR is a widely used, minimally invasive technique that involves resecting the lesion with a diathermic snare after submucosal injection. While effective and safe, EMR often necessitates piecemeal resection, increasing the risk of local recurrence. In contrast, ESD, developed in Asia, allows for en bloc resection regardless of lesion size, ensuring more accurate histopathological assessment and lower recurrence rates. However, ESD requires greater technical expertise, has longer procedural times, and carries a higher risk of complications.

In Western clinical practice, EMR remains the standard treatment, whereas ESD is selectively performed in high-expertise centers. Given the lack of randomized controlled trials comparing EMR and ESD in Western populations, this study aims to provide robust clinical evidence to guide treatment decisions.

The primary objective of this study is to compare the recurrence/residual adenomatous tissue rate at 6 and 12 months between EMR and ESD in patients with LST-G lesions of the colon and rectum


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Diagnosis of Laterally Spreading Tumor - Granular Type (LST-G) ≥ 20 mm in the colon or rectum with an indication for endoscopic resection.
* Life expectancy \> 10 years.
* Ability to understand and sign the informed consent form, demonstrating comprehension of the study and willingness to participate.

Exclusion Criteria:

* Diagnosis of Laterally Spreading Tumor - Non-Granular Type (LST-NG).
* Presence of depressed areas within the lesion.
* Lesions located on a scar or anastomosis site.
* Lesions classified as Kudo Vi or Vn pattern.
* History of chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease).
* Diagnosis of hereditary polyposis syndromes (e.g., familial adenomatous polyposis, Lynch syndrome).
Study of CS3006 in Subjects With Locally Advanced or Metastatic Solid Tumors

This is a multicenter, open label, sequential-cohort, dose escalation \& expansion phase I study to evaluate the clinical safety, tolerability, PK, and preliminary efficacy of CS3006 and to establish the Maximum Tolerated Dose (MTD）, if any, Recommended Phase II Doses (RP2Ds) and regimen of CS3006. The study is composed of two parts: Part 1 for dose escalation and Part 2 for dose expansion.


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide written informed consent for the trial.
2. Subjects must have a histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Life expectancy ≥ 12 weeks.
5. Able to swallow and retain oral medication.
6. Subject must have adequate organ function.
7. Use of effective contraception.

Exclusion Criteria:

1. Subjects receiving cancer therapy at the time of enrollment.
2. Has had prior chemotherapy, targeted therapy, immunotherapy or any other agents used as systemic treatment for cancer, within 14 days of the first dose of investigational product administration or who has not recovered from adverse events due to a previously administered agent.
3. Previous treatment with a MEK inhibitor.
4. Use of any investigational anti-cancer drug within 28 days before the first investigational product administration.
5. Current use of a prohibited medication.
6. Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs.
7. Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
8. Primary malignancy of the central nervous system.
9. Evidence of severe or uncontrolled systemic diseases.
10. Subjects with clinically significant cardiovascular disease.
11. Human Immunodeficiency Virus (HIV) infection.
12. Subjects with active Hepatitis B or C infection.
13. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the investigational product or excipients.
14. Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol.
15. Unwillingness or inability to follow the procedures outlined in the protocol.

For more information regarding trial participation, please contact at cstonera@cstonepharma.com
Evaluation of Monolithic Milled Complete Removable Dentures

The use of complete removable dental prostheses (CRDP) is a reliable and effective treatment option for the rehabilitation of edentulous persons.

In recent years, the use of computer-aided design/computer-aided manufacturing (CAD/CAM) methods has become more popular for the fabrication of CRDPs, including subtractive methods (milling) from a prefabricated resin puck. They present various advantages compared to conventional fabrication methods, namely improved mechanical properties, superior surface characteristics, shortened manufacturing time and lower cost for the patient.

However, one of the shortcomings in the manufacturing of CRDPs from a single block of resin is obtaining an adequate esthetic outcome, as the transition between the gingiva-colored (pink) and tooth-colored (white) resin is not as precise as with prefabricated prosthetic teeth which are incorporated into a denture base. A novel technology has recently been launched on the market and includes a new design of distribution of pink and white resin inside a prefabricated resin puck, which would allow a superior esthetic outcome than previous techniques.

The aim of this pilot study is to assess the end result of one of the available systems used for fabricating digital dentures (Ivoclar® Digital Denture®), while using the corresponding monolithic resin puck (Ivoclar® Ivotion Denture System®), and therefore determining whether this new technique is an adequate option for treating edentulous patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Informed Consent as documented by signature
* Healed edentulous maxilla and mandible (minimum one year since last extraction)

Exclusion Criteria:

* Contraindications to the medical devices used, e.g. known hypersensitivity or allergy
* Vulnerable subjects
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the investigation
* Participation in another investigation with a MD in the field of dentistry
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Reported severe bruxism or clenching habits, clinically present oro-facial pain
* Width of edentulous maxilla \> 80 mm
* Width of edentulous mandible \> 80 mm
* Vertical height needed for maxillary prosthesis \> 38 mm
* Vertical height needed for mandibular prosthesis \> 38 mm
* Depression: Geriatric Depression Scale \> 9
* Xerostomia: SSFR ≤ 0.7ml/min
* Dementia: Clock-Drawing Test ≤ 5
Stereotactic Radiosurgery With Nivolumab and Valproate in Patients With Recurrent Glioblastoma

The purpose of this study is to evaluate the safety and feasibility of the immunotherapeutic agent nivolumab given in combination with gamma knife therapy and valproate in patients with recurrent glioblastoma, a common and lethal type of brain cancer.

Immune checkpoint inhibitors have the potential to treat a wide range of diverse cancers. Of particular interest to researchers is the PD-1 receptor-ligand interaction, a major pathway that many cancers hijack in order to suppress immune control. Anti-PD-1 antibodies such as nivolumab show a strong potential to treat many types of cancers including glioblastoma, the most common and most lethal brain cancer.

This study will examine a means of further focusing immune response on glioblastoma by combining stereotactic "gamma knife" radiosurgery with nivolumab. The rationale behind this intervention is that the radiation therapy will enhance immune response rate by providing additional tumor antigens from dying cells. Additionally, a study from investigators at Johns Hopkins indicates that histone deacetylase (HDAC) inhibitors may boost the anti-cancer efficacy of PD-1 antibodies like nivolumab. Valproate, a class I HDAC inhibitor, will be used concurrently with nivolumab with the goal of enhancing the effects of both the nivolumab and the radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed malignant, recurrent glioblastoma or gliosarcoma
* Subject must have adequate organ function
* Subject must still be able to care for most of his or her personal needs

Exclusion Criteria:

* Subject is pregnant
* Subject has extracranial metastatic or leptomeningeal disease
* Subject has an additional malignancy that is progressing or requires active treatment, exceptions being basal cell and squamous cell carcinomas of the skin, indolent prostate cancer, chronic lymphocytic leukemia, or in situ cervical cancer
* Subject has received chemotherapy, biological therapy, or had surgery 4 weeks prior to beginning the study
* Subject has had radiation therapy within 10 weeks prior to entering beginning the study
* Subject has had prior therapy with bevacizumab
* Subject has had previous treatment with carmustine wafer except when administered as first-line treatment no less than six months prior to beginning the study
* Subject requires escalating supraphysiologic doses of corticosteroids greater than 2 mg of dexamethasone or an equivalent
* Active autoimmune disease requiring systemic treatment within the past 3 months or any syndrome that requires immunosuppressive agents
* Interstitial lung disease or active, non-infectious pneumonitis
* Evidence of greater than Grade 1 CNS hemorrhage or greater than Grade 3 venous thromboembolism
* History of uncontrolled cardiac disease
* Subject unable or unwilling to have a head contrast enhanced MRI
Carotid Ultrasound in the Evaluation of Heart Failure

Coronary artery disease (CAD, cholesterol plaque buildup in the heart arteries) is the most common cause of left ventricular systolic dysfunction (weakening of the heart muscle). The standard test to find coronary artery disease is coronary angiography. This test is highly accurate but is invasive and carries a small risk of complications. This study investigates ultrasound of the carotid (neck) arteries as a screening test for severe coronary artery disease as a cause of left ventricular systolic dysfunction. It is hypothesized that carotid ultrasound will have excellent negative predictive value for severe CAD.

Coronary artery disease (CAD, cholesterol plaque buildup in the heart arteries) is the most common cause of left ventricular systolic dysfunction (weakening of the heart muscle). The standard test to find coronary artery disease is coronary angiography. This test is highly accurate but is invasive and carries a small risk of complications. This study investigates ultrasound of the carotid (neck) arteries as a screening test for severe coronary artery disease as a cause of left ventricular systolic dysfunction. It is hypothesized that carotid ultrasound will have excellent negative predictive value for severe CAD.

Eligibility Criteria:
Inclusion Criteria:

* LVEF 40% or less

Exclusion Criteria:

* Prior diagnosis of coronary or carotid obstructive atherosclerosis
Exposure, D-cycloserine Enhancement, and Functional Magnetic Resonance Imaging (fMRI) in Snake Phobics

The aim of the present study is to determine whether people receiving d-cycloserine and exposure therapy show different brain reactions to symptom provocation compared to people receiving placebo and exposure therapy.

D-cycloserine (DCS) is a partial N-methyl-D-aspartate (NMDA) receptor agonist that may improve or accelerate extinction learning. We will randomly assign people with snake phobia to receive DCS or placebo, and then provide all participants with exposure therapy. We will examine whether people receiving DCS and vs. placebo show different brain reactions to symptom provocation before and after exposure therapy.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of specific phobia (snakes)

Exclusion Criteria:

* History of psychosis, obsessive-compulsive disorder, or mania
* Recent substance abuse or suicidality
* Previous receipt of study treatments
VTX002 Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis

This is a study to understand if taking VTX002 daily as a tablet orally is safe and effective in participants diagnosed with moderate to severe ulcerative colitis (UC). Approximately 189 participants will take VTX002 Dose A, VTX002 Dose B, or matching placebo, once daily.

The study consists of a 28-day Screening Period (to see if a participant qualifies for the study), a 13-week double-blind period (a participant receives either active Dose A, Dose B or Placebo), a Long-Term Extension (LTE) Treatment Period of up to 39 weeks, an Open-Label Extension (OLE) Treatment Period of up to 143 weeks, and a 2-week Follow-Up Period. The maximal duration of treatment including the Induction Period, LTE and OLE will be 36 months.

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of VTX002 in subjects with moderately to severely active UC following daily oral administration of VTX002 as a tablet. Approximately 189 eligible subjects will be randomized in a 1:1:1 ratio to receive VTX002 Dose A, VTX002 Dose B, or matching placebo, once daily (approximately 63 subjects per treatment group).

The study consists of a 28-day Screening Period, a 13-week double-blind Induction Treatment Period (including 7 days of titration followed by 12 weeks of treatment at the assigned dose), a Long-Term Extension (LTE) Treatment Period of up to 39 weeks, an Open-Label Extension (OLE) Treatment Period of up to 143 weeks, and a 2-week Follow-Up Period. The maximal duration of treatment including the Induction Period, LTE and OLE will be 36 months.

Objectives Primary Objective

• Assess the efficacy of VTX002 when administered for 13 weeks on clinical remission

Secondary Objectives

* Assess the efficacy of VTX002 when administered for 13 weeks on endoscopic changes, symptomatic response and remission, histology, and mucosal healing
* Assess the safety and tolerability of VTX002
* Assess the pharmacokinetics (PK) of VTX002

Long-Term and Open-Label Extension Objectives

* Assess the efficacy of VTX002 through the LTE and OLE Treatment Periods on endoscopic changes, symptomatic response and remission, histology, and mucosal healing
* Assess the safety of VTX002 through the LTE and OLE Treatment Periods

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with UC ≥ 3 months prior to Screening.
* Active UC confirmed by endoscopy

Exclusion Criteria:

* Severe extensive colitis
* Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
* Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
Dynamics of Stroke Volume and Cardiac Output During Parabolic Flight, and Its Relationship to Intravascular Volume

To understand the cardiovascular reactions of the human body to changing conditions of gravity is an important aim of space science. In this context, cardiac output (CO) is a key value to estimate the human cardiovascular system.

The main objective of this experiment is to determine the effects of parabolic flight on intravascular volume, and how these changes modulate the complex haemodynamics induced by the parabolas.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers (men or women),
* aged from 18 to 55,
* affiliated to a Social Security system,
* who accept to take part in the study,
* who have given their written stated consent,
* who already participated in parabolic flights (even in the same campaign)
* All subjects will pass a medical examination similar to a standard aviation medical examination for private pilot aptitude. There will be no additional test performed for subject selection

Exclusion Criteria:

* person who took part in a previous biomedical research protocol, of which exclusion period is not terminated,
* pregnant women