cyrilzakka/clinical-trials huggingface dataset:
TEOSYAL® PureSense ULTRA DEEP Versus Restylane® Lidocaine for the Correction of Moderate to Severe Nasolabial Folds in Chinese Adults

This is a prospective, multi-center, randomized, controlled, subject- and evaluator-blinded clinical investigation to demonstrate non-inferiority of TEOSYAL® PureSense ULTRA DEEP compared to Restylane® Lidocaine for the correction of moderate to severe NLF in Chinese adults.

Eligible subjects will be enrolled and randomized either to the treatment group or control group in a 1:1 ratio on Day 0. Each subject assigned to the treatment group will receive TEOSYAL® PureSense ULTRA DEEP in both NLFs, whereas subjects assigned to the control group will receive Restylane® Lidocaine.

The treating investigator will administer the corresponding product in both NLFs of the subject on Day 0.

All subjects will return to the site at 4, 12, 24, 36, and 52 weeks after the last treatment for effectiveness and safety assessment. All subjects will receive a safety phone call 7 days after the initial treatment at baseline, and after the touch-up treatment, if applicable.


Eligibility Criteria:
Inclusion Criteria:

1. Chinese male and female, 18 years of age or older.
2. Subject desiring bilateral NLF treatment.
3. Has symmetrical NLFs, with the same WSRS score of 3 (moderate) or 4 (severe) for both right and left NLFs, as determined on live assessment by the blinded evaluator.
4. Subject willing to abstain from all other facial aesthetic procedures/therapies that could interfere with effectiveness evaluations (e.g., dermal fillers outside of this investigation, toxin treatments, facial ablative or fractional laser, intense pulsed light \[IPL\], microdermabrasion, chemical peels, skin bleaching agents, non-ablative laser, or energy-based device for skin-tightening, surgical procedures, etc.) during participation in the investigation.
5. Woman of childbearing potential must be using a highly effective method of birth control .
6. Subject understands and is able to follow instructions and complete all scheduled visits.
7. Subjects who voluntarily decided the participation of the investigation and signed the informed consent.

Exclusion Criteria:

1. Known hypersensitivity or previous allergic reaction to any component of the study devices
2. Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
3. History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.
4. History of connective tissue disease.
5. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
6. Subjects who participated in other clinical investigation within 30 days, or in an exclusion period from a previous study.
Acute Cardio-metabolic Responses to Montmorency Tart Cherry Supplementation in Metabolic Syndrome Patients

The present study examined the effect of Montmorency tart cherry juice and capsules on functional and blood-based cardio-metabolic markers in humans with Metabolic Syndrome. Participants received a single bolus of Montmorency tart cherry juice, Montmorency tart cherry capsules and placebo in a random, crossover trial. Outcome variables were measured immediately pre- and up to 5 hours post-bolus. It was hypothesised that Montmorency tart cherry juice and capsules would improve cardio-metabolic markers. Furthermore, it was hypothesised that Montmorency tart cherry capsules would be more beneficial than Montmorency tart cherry juice due to increased bioavailability of phytochemicals.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoker,

Meet 3 of 5 criteria for Metabolic Syndrome based on National Cholesterol Education Program-Adult Treatment Panel III guidelines:

1. Waist Circumference: \>102cm (men), \>88cm (women)
2. Fasting Serum Triglycerides: ≥1.69 mmol.L-1
3. Fasting High Density Lipoprotein: \<1.03 mmol.L-1 (men), \<1.29 mmol.L-1 (women)
4. Blood Pressure: ≥130 mmHg SBP or ≥85 mmHg DBP
5. Fasting Plasma Glucose: ≥6.1 mmol.L-1

Exclusion Criteria:

* Current or previous history of gastrointestinal, cardiovascular, hepatic or renal disease, currently diagnosed with diabetes or uncontrolled hypertension (≥160/100 mmHg), allergy to maltodextrin or specific fruit products and those currently taking medication (such as steroids, NSAIDs, antibiotics, antihypertensive, hypoglycaemic, lipid-lowering drugs) or currently using any nutritional or antioxidant supplement. Heavy alcohol consumption (\>14 units per week).
Impact on French Physician's Haemophilia Treatment Management Decision Based on Systematic Joint Examination

This low interventional study aims to describe if and how the haemophilia treatment management decisions are impacted by a systematic joint examination (ultrasound, functional, physical) in patients with haemophilia A in France.

The study will assess the behavior of the physicians with regards to haemophilia management decisions, and if systematic joint examination have an impact on their decisions. The main objective is to evaluate if the use of HEAD-US and Haemophilia Joint Health Score (HJHS) have an impact on these decisions. The study is classified as a low-interventional study due to mandated systematically assessment (HEAD-US, HJHS) on patients which may not be part of routine clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Age 6-40 years
* Haemophilia A patients treated with plasma-derived factor VIII (pdFVIII) or recombinant (conventional or extended half-life) factor VIII (rFVIII)
* At least one joint bleeding episode prior to inclusion
* Signed informed consent

Exclusion Criteria:

* Enrolment in another concurrent clinical interventional study, or intake of an Investigational Medicinal Product, within three months prior to inclusion in the study
* Presence of factor VIII antibodies (inhibitors) (≥0.60 Bethesda Unit \[BU\]/mL) at the latest available inhibitor test
* Joint surgery over the past year prior to inclusion in one of the following joints; left knee, right knee, left elbow, right elbow, left ankle and right ankle
* More than one joint replacement
Beta-Glucan Driven vs. Empirical Antifungal Therapy in Critically Ill Patients

This study is aimed to compare the duration of standard anti fungal therapy in high risk ICU patients with a strategy driven by BetaDGlucan test result


Eligibility Criteria:
Inclusion Criteria:

* ICU admission (minimum of 48 hours in ICU with an expected length of stay of at least 48 hours)
* Ongoing Mechanical Ventilation
* Presence of CVC
* Sepsis/Septic Shock development while receiving broad spectrum antibiotics
* Positivity of Candida Score or Candida Colonization Index in absence of septic shock

Exclusion Criteria:

* Complicated Candida Infection
* Already ongoing anti fungal therapy
* Beta Glucan test not available
* Absence of informed consent
* Immunesuppressive status (long-term immunesuppresive or steroids therapy; AIDS; WBC \<1000/mmc or neutrophils \<500/mmc)
* Pregnancy
* Already enrolled in other interventional studies
Efficacy of Low-dose Intra-articular Tranexamic Acid in Total Knee Replacement

The purpose of this study is to determine 1) the effective dosage of intra-articular tranexamic acid injection for controlling blood loss and blood transfusion requirement in conventional total knee replacement, and 2) whether the blood loss reduction effect depended on the dose of tranexamic acid used.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed as primary knee osteoarthritis and underwent unilateral primary cemented conventional total knee replacement
* no risk of abnormal bleeding tendency or bleeding disorder (normal coagulogram, serum creatinine \< 2.0 mg/dL, stop nonsteroidal anti-inflammatory drugs and antiplatelet drugs more than 7 days
* no contra-indication for tranexamic acid use (no active intravascular clotting process, no acquired defective colour vision, no subarachnoid hemorrhage, no hypersensitivity to TXA, and no any of history of serious adverse effects, thrombotic disorder and hematuria)

Exclusion Criteria:

* incomplete data collection, for example, malfunctioned drain or accidental drain removal.
The State of Nebulizer Therapy in Russian Federation

It is known that the inhalation (nebulizer) use of drugs is of great importance in the intensive care of patients with acute and chronic respiratory failure of various origins.

Searching PubMed data for the last 5 years (2017-2022) for the keywords "nebulizer therapy" revealed 533 publications, and "mesh nebulizer therapy" - only 25 sources.

During the same period, the national database (E-Library) has 75 publications for the keywords "nebulizer therapy", and 4 sources for "mesh nebulizer therapy".

It should be noted that almost all publications are devoted to the use of nebulizers for specific diseases and pathological syndromes. There are no works evaluating the adherence of specialists, systemic indications and actually used methods.

The aim of trial is to study the current state of the use of nebulizer therapy in medical organizations and identify ways to improve its effectiveness This study is planned to be carried out using a questionnaire using a database based on the Internet electronic survey form.

We intend to involve at least 3 medical organizations in the subjects of the Russian Federation with a population of up to 1 million people; at least 5 medical organizations in the constituent entities of the Russian Federation with a population level of 1 to 3 million people, at least 7 organizations with a population level of more than 3 million people. In cities of the Russian Federation with a population of 1 million people or more - at least 5 medical organizations, and in the cities of Moscow and St. Petersburg - at least 10 medical organizations.

Eligibility Criteria:
Inclusion Criteria:

* Medical physicians

Exclusion Criteria:

* Lack of experience in conducting nebulizer therapy. Lack of technical capability for nebulizer therapy in a medical organization.
Phase Ⅱ Study of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Stage Ⅲ Nasopharyngeal Carcinoma

The primary objective of this study is to determine the tolerance and overall survival in patients with stage Ⅲ NPC treated with neoadjuvant chemotherapy and concurrent chemoradiation.

Secondary objectives of the study are to evaluate the distant metastases free survival, and disease-free survival of patients with stage Ⅲ treated with this regimen.

Concurrent chemoradiation is the standard treatment for locally advanced NPC. The survival benefit gained from adding neoadjuvant chemotherapy to concurrent chemoradiation has never been defined. In the present trail, we hope to assess the tolerance and survival benefits of neoadjuvant chemotherapy followed by concurrent chemoradiation in patients with stage Ⅲ NPC.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven differentiated non-keratinizing carcinoma, and undifferentiated carcinoma of the nasopharynx.
* Stage Ⅲ disease
* KPS \>70
* Age between 18-70
* Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of \> 2000 cells/mm3, platelet count of \> 100,000 cells/mm3 (pre treatment without intervention). Bilirubin \< 1.5 mg/dl, AST or ALT\<2 x upper normal, serum creatinine\<1.5mg/dl, creatinine clearance \>50ml/min.
* No prior radiation treatment to the head and neck or any prior chemotherapy
* Patients with no prior malignancy (not include basal cell carcinoma of skin)

Exclusion Criteria:

* Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations.
* Prior radiotherapy to the head and neck region for any reason.
* Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease.
* Patients with previous or simultaneous primaries, excluding basal cell carcinoma or squamous cell carcinoma of skin.
* Pregnant women
Identifying Molecular Drivers of Cancer

The primary aim of this study is to identify drivers of cancer by performing comprehensive genetic, proteomic, and metabolomic characterization of patient samples as a basis for understanding the underlying cause of disease.

This study involves looking at the DNA, RNA, proteins, and metabolites in blood and tissue samples collected from subjects and linking them to their health information. By doing so, researchers hope to discover the underlying molecular causes of human diseases with the hope that this information can be used for the development of diagnostic tests and more effective treatments.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnoses with cancer but healthy enough to undergo a biopsy procedure
* Between the ages of 18 and 100

Exclusion Criteria:

* Patients who are pregnant
NIV NAVA Versus NIV-PS in Pediatric Patients - Pilot Study

This pilot study will be an observational no randomize study in which the NiNAVAped protocol will be applied solely to the NIV NAVA arm.

This pilot study will be an observational no randomize study in which the NiNAVAped protocol will be applied solely to the NIV NAVA arm.

Every PICU will have to include 3 patients in the Pilot study before starting the clinical trial, which means that the pilot study will involve a maximum of 60 patients.

Should the Pilot study reveal deficiencies in the NiNAVAped design, the protocol would be improved accordingly.

There will be a specific consent document during the Pilot study. The Pilot study will be published in a scientific journal.

Eligibility Criteria:
Inclusion Criteria:

* Age: \> 1 month age to 18 years
* Moderate/severe Pediatric Acute Respiratory failure of any origin evaluated after a period of respiratory stabilization (aspiration of secretions, physiotherapy, oxygen and nebulized therapy) when the attending pediatric intensive care physician believes that the patient is likely to require endotracheal intubation (ETI).
* Non intubated
* Admitted to the PICU
* Minimally agitated/sedated: between -2 and +2 on the Richmond agitation-sedation scale (Table 2)

Exclusion Criteria:

1. Patients younger than 1 month or older than 18 year
2. Patients who need immediate endotracheal intubation: i.e.: Severe ARF with signs of exhaustion
3. Facial trauma/burns
4. Recent facial, upper way, or upper gastrointestinal tract surgery excepting gastrostomy for feeding
5. Fixed obstruction of the upper airway
6. Inability to protect airway
7. Life threatening hypoxemia defined as SpaO2 \<90% with FiO2 \> 0.8 on hi-flow oxygen.
8. Hemodynamic instability: refractory at volume expansion \>60 ml/kg and dopamine \>10 mcg/kg/min
9. Impaired consciousness defined as Glasgow coma scale \< 10.
10. Bowel obstruction.
11. Untreated pneumothorax.
12. Poor short term prognosis (high risk of death in the next 3 months)
13. Known esophageal problem (hiatal hernia, esophageal varicosities)
14. Active upper gastro-intestinal bleeding or any other contraindication to the insertion of a NG tube.
15. Neuromuscular disease
16. Vomiting
17. Cough or gag reflex impairment.
18. Cyanotic congenital heart disease.
19. Complete absence of cooperation
20. This patient has been included (randomized) previously in the study
Topical Sirolimus for the Treatment of Pachyonychia Congenita (PC)

A study to evaluate safety and efficacy of topical sirolimus to treat plantar keratoderma in adults with PC. Subjects may receive either placebo or treatment with at least 1 foot receiving topical sirolimus at some time. For certain phases of the study treatment assignment to the right and left foot will be randomized in a double blind fashion. Blood levels will test systemic absorption of sirolimus. Other safety and efficacy measures will be taken through the 39-week study duration. Funding Source - FDA OOPD


Eligibility Criteria:
Inclusion Criteria:

Subjects must:

* Be capable of understanding the purpose and risks of the study and sign a written Informed Consent Form (ICF)
* Be male or female ≥ 16 years of age at the time of the screening visit
* Have a confirmed diagnosis of PC by genotyping (e.g., familial) and clinically correlated painful keratoderma.
* Have roughly symmetrical calluses of similar severity on the plantar surface of both feet
* Women of childbearing potential must have a negative serum pregnancy test
* Subjects, whether male or female, with reproductive potential and who are sexually active must agree to use double-barrier contraception methods

Exclusion Criteria:

A Subject with any of the following criteria is not eligible for inclusion in this study:

* Use of other investigational drugs within 30 days of the screening visit and/or has not recovered from any side effects of prior investigational drugs or procedure in the affected area (e.g., a biopsy)
* Significant condition in the dermatologic treatment area such as trauma, or nonhealing chronic wound
* Pregnant or nursing (lactating) female, or a positive serum pregnancy test
* Active infection either systemic or local near the site of treatment requiring chronic or prolonged use of antimicrobial agents
* Known immunodeficiency including: Hepatitis A; Hepatitis B; Hepatitis C; Human Immunodeficiency Virus (HIV)

Prior and Current Treatment

* Unable to be discontinued from drugs known to either be inducers or inhibitors of CYP3A4/5 enzymes
* Unable to be discontinued from drugs known to be P-glycoprotein inhibitors
The Effect of Mechanical Ventilation on the Occurrence of Myocardial Ischemia: a Pilot Study

The goal of the proposed pilot study is to determine which method can detect myocardial ischemia at the predefined timepoints during endo-CABG. Additionally, the investigators want to examine the influence of mechanical ventilation on the occurrence of myocardial ischemia in patients undergoing endo-CABG.

CABG is the most effective therapy for patients suffering from coronary artery disease, a condition which annually affects 126 million people worldwide. During this surgery, cardiopulmonary bypass (CPB) takes over the function of the heart and lungs. As a result of the emergence of minimally invasive cardiac surgery (MICS) (e.g. endoscopic-CABG), peripheral CPB with femoral arterial cannulation became the most commonly utilized strategy. However, the use of retrograde arterial perfusion is not without risk. It may result in the upper body and coronary arteries being perfused with deoxygenated blood. The hypoxemia will induce myocardial ischemia and this can harm the cardiac myocytes. A solution for this inconvenience is still lacking. Literature reports that establishing adequate ventilation support should help overcome this phenomenon. However, this approach has not yet been investigated in a clinical trial. In general, this phenomenon is not well recognized in the typical surgical setting, and limited research has been done.

The goal of the proposed pilot study is to determine which method can detect myocardial ischemia at the predefined timepoints during endo-CABG. Additionally, the investigators want to examine the influence of mechanical ventilation on the occurrence of myocardial ischemia in patients undergoing endo-CABG.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Patients undergoing their first elective endo-CABG procedure
* Patients capable of signing the informed consent
* Patients able to speak Dutch or French

Exclusion Criteria:

* Ongoing participation in another trial
* Ejection fraction \< 50%
* Lung diseases (COPD, asthma)
* Use of corticosteroids
Impact Of A Training Program And Organization On The Management Of Stroke In The Acute Phase (AVC-II)

Acute stroke management represents a true medical emergency that requires prompt diagnosis and urgent treatment. In a previous exhaustive cohort study conducted in the Rhône region, France (AVC69) (Porthault et al. 2013) the investigators observed that only a small percentage of patients could access to thrombolysis in time. In this cohort of 1306 patients treated in one of the emergency department of the Rhone region for a suspected stroke, 84% of patients reached hospital through an emergency department instead of going directly to a stroke unit. Among those patients, only 2% were finally thrombolysed. A significant part of patients arrived in the emergency department too late to be thrombolysed. However, among the subset of ischemic stroke patients who reach emergency department less than 3 hours after symptoms onset, and who had no clinical or radiological exclusion criteria for thrombolysis, only 15 % were thrombolysed. The hypothesis was that an intervention designed to improve ED professional's knowledge and skills and to develop together efficient clinical pathway would decrease door-to imaging time and consequently door-to needle time and eventually improve overall thrombolysis rate.

The investigators have conducted a cluster randomized controlled stepped wedge trial. All adult patients with suspected stroke arriving in one of the participating ED were included in the study along five successive four-month periods. The program featured: development of written materials (booklets) and video (film), and one day session of standardized training for trainers, at least one nurse and one physician of all EDs, with formal presentation to improve knowledge, and simulation to improve skills for using the "FAST" tool (nurses) and the "NIHSS" score (ED physicians). Additionally, a clinical pathway was developed to adapt general evidence based guidelines to the local organization. The primary outcome is the door-to imaging time.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients admitted to one of the participating ED for suspected ischemic stroke less than or equal to 4 hours from symptoms onset were included in the study.

Exclusion Criteria:

* age below 18
* admission to the ED more than 4 hours after symptoms onset or unknown time of first symptoms
Effects of Nicotinamide Riboside on Metabolism and Vascular Function

The purpose of this study is to determine the effects of Nicotinamide Riboside (NR) supplementation on metabolism and vascular function following high-fat meal. Differences between young (18-35) and older (60-75) adults will be determined.

The purpose of this study is to determine the effects of 7 days of Nicotinamide Riboside (NR) or placebo supplementation on metabolism and vascular function following high-fat meal. Differences between young (18-35) and older (60-75) adults will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 35 (young) and 60 to 75 (older)
* Normo- or pre-hypertensive (blood pressure \<140/90 mmHg)
* Non-smokers
* Able to give informed consent and participate in all laboratory visits

Exclusion Criteria:

* Currently taking any medications that could interfere with cardiovascular or metabolic outcomes will be excluded from the study (e.g., beta-blockers)
* Known metabolic (e.g. Type I or Type II diabetes, cardiovascular disease, etc.) or immunologic (e.g. HIV, cancer, autoimmune, etc.) diseases
* Food allergies to egg, milk, soy or wheat
* Women who are pregnant or planning to become pregnant during the course of the study,
* Pacemaker or other implanted device
* Unwilling to participate in the experimental protocol or blood draws will be excluded