cyrilzakka/clinical-trials huggingface dataset:
Impact of Continuous Regional Analgesia in Severe Trauma Patients

Regional analgesia, based on its physiological effects and efficacy, is used for optimal perioperative pain relief. However, for acute pain in multiple trauma patients in a critical condition, it has not been prospectively studied. The use of regional anaesthesia in this group of patients extend to the management of trauma patients and of other painful procedures performed at the patient's bed. The use of RA in such patients must be analyzed in the light of associated conditions that can increase the risk of systemic toxicity and complications: coagulopathies, infection, immunosuppressive states, sedation and problems associated with mechanical ventilation. The investigators aim to assess the role of continuous peripheral nerve blocks (CPNB) in multiple trauma patients, in order to show the benefits in terms of opiates consumption decrease, sedation limitation, improvement in ventilator free days and patients outcome

Inclusion of multiple trauma patients with limb fractures and need for sedation and prolonged mechanical ventilation.

Patients should meet the following criterias: pressure of cerebral perfusion\>60mmHg, normothermia, PaCO2 35-40 mmHg, pH\> 7.20, Normal coagulation parameters, Hb\> 8g / dl (without head trauma) or Hb\> 10g / dl (if associated head trauma).

Randomization in two patients groups: "RA group" versus "NoRA Group

Methods:

group without locoregional anesthesia: Sedation using midazolam and sufentanil: Multi-Daily adjustment of doses every 4 hours using Behavioral Pain Scale score \<4 and Ramsay Score \> 4.

group with locoregional anesthesia: Sedation using midazolam and sufentanil: Multi-Daily adjustment of doses every 4 hours using Behavioral Pain Scale score \<4 and Ramsay Score \> 4 + peronerval block catheter from 0 to 24h after admission in intensive care unit using ropivacaine 0.2% with a continuous infusion at 1mL/10 Kg /H Follow-up up to 5 days for the 2 group. The main objective: sufentanil consumption (reported in µg / kg / d) for the same levels of Behavioral Pain Scale and Ramsay Scales values.

Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years
* Multiple trauma Patient ( with or without head trauma)
* Patient admitted to ICU
* Patient with limb fracture (s)
* Patient requiring sedation and mechanical ventilation for more than 48h
* Patient affiliated to a social security system
* Patient whose informed consent was obtained from the family

Exclusion Criteria:

* Patient currently enrolled in another trial
* Patient with coagulation disorders
* Patient whose access to the puncture sites is not feasible (underlying lesions)
* Patient with allergies to local anesthetics (LA)
* Patient whose family did not give informed consent
* Patient younger than 15 years and 3 months
* Tetraplegic Patient
* Dying patients
* Patients with more than 3 different fracture sites
Use of Critical-Care Pain Observation Tool and Bispectral Index for Detection of Pain in Brain Injured Patients

Brain injured patients are at high risk of pain due to the illness itself and a variety of nociceptive procedures in intensive care unit. Since the disorder of consciousness, speech, and movement, it is usually difficult for them to self-report the presence of pain reliably. The Critical-Care Pain observation Tool (CPOT) has been recommended for clinical use in the critically ill patients when self-report pain is unavailable. Besides, it seems that the bispectral index (BIS), a quantified electroencephalogram instrument, can be used for pain assessment along with the CPOT tool in some nonverbal critical ill patients (e.g., intubated and deep sedation). However, the validity and reliability of CPOT and BIS for pain assessment in brain injured patients are still uncertain so far. So the aim of this research is to investigate the value of CPOT and BIS for pain evaluation in this specific patient group.


Eligibility Criteria:
Inclusion Criteria:

* patients with brain injury and artificial airway

Exclusion Criteria:

* age under 18 years,
* quadriplegia,
* administration of paralytic medications within 24 hours,
* if the patient failed the quality test of BIS signal,
* impending death,
* be included in any other research.
Transcystic Versus Transanastomotic Tube Drainage in Right Lobe LDLT

To evaluate the safety and effectiveness of the use of transcystic biliary drainage tube (not transanastomotic) in comparison to the usual transanastomotic biliary drainage tube.

a biliary drainage tube is usually inserted into the biliary passage after choledocho-choledochostomy (bile duct to bile duct joining).

A 4F or 5F biliary catheter (Marquat Genie biomedical, france) is used in all cases.

the study is to compare the effectiveness and safety of 2 different placement techniques:

1. the usual trans-anastomotic position (the tube is placed across the anastomosis line with the tip inside the intrahepatic biliary branches) through an opening in the wall of the recipient's common bile duct
2. a transcystic non-anastomotic position (the tube is placed through the cystic duct opening into the distal common bile duct not passing through anastomosis)

Eligibility Criteria:
Inclusion Criteria:

* living donor liver transplantation
* single bile duct in the graft

Exclusion Criteria:

* multiple bile ducts
MUNIX Variability in Healthy Subjects

Motor unit number index (MUNIX) is an electrophysiological technique that estimates the number of motor units in a muscle. This data can be changed by natural evolution or by treatment in peripheral neuropathy. Alfortunately, normal value for MUNIX variation does not exist. Thus, it is difficult to assume improvement or worsening of the MUNIX for an individual subject.

Our objective is to calculate normal variation of MUNIX in 4 muscles : tibialis anterior, abductor digiti mini, abductor pollicis brevis et deltoideus. Measurement will be performed at inclusion and 3 monthes later in 100 healthy subjects. This trial will be prospective in several French centres sepecialized in neuromuscular evaluation

Motor unit number index (MUNIX) is an electrophysiological technique that estimates the number of motor units in a muscle. This data can be changed by natural evolution or by treatment in peripheral neuropathy. Alfortunately, normal value for MUNIX variation does not exist. Thus, it is difficult to assume improvement or worsening of the MUNIX for an individual subject.

Our objective is to calculate normal variation of MUNIX in 4 muscles: tibialis anterior, abductor digiti mini, abductor pollicis brevis et deltoideus. Measurement will be performed at inclusion and 3 monthes later in 100 healthy subjects. This trial will be prospective in several French centres sepecialized in neuromuscular evaluation

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without neuromuscular disoreders or others diseases which can interfer with MUNIX measurement
* More than 18 years old

Exclusion Criteria:

* Less than 18 years old
* Diseases which can interfer with MUNIX measurement
Obstructed Defaecation: Proctography Versus Ultrasound in Symptomatic Patients

Obstructed defaecation syndrome is a common problem in which patients experience difficulty to evacuate stools and feel that the bowel is incompletely empty, which causes the need to put fingers in to the rectum or vaginal to empty the rectum. These symptoms have a significant effect on social, physical, emotional and sexual wellbeing all of which have impact on quality of life. These symptoms are caused by posterior compartment disorders such as the last part of the large bowel bulging into the vagina (rectocele), the small bowel pressing on the rectum (enterocele), a circumferential infolding of the rectal wall (intussusception) or paradoxical pelvic floor contraction during attempts to evacuate (anismus).

Currently the evacuation proctogram is the gold standard for diagnosis of posterior compartment disorders. This technique, however, exposes the patient to ionising radiation, requires preparation of the small and large bowel with contrast and defaecation in a non-private setting, which most women find embarrassing and unpleasant. Over the years, research has focussed on identifying alternatives that are better tolerated to substitute evacuation proctography. Ultrasound is a widely available, non-expensive, non-invasive, fast and a well-tolerated method for the dynamic and static imaging of the pelvic floor without the use of ionising radiation. The level of agreement between transperineal ultrasound (TPUS) and proctography for varies widely. Endovaginal ultrasound (EVUS) not yet compared to proctography. The aim of this study is to assess the level of agreement between ultrasound (EVUS and TPUS) and evacuation proctography in the diagnosis of posterior compartment disorders.


Eligibility Criteria:
Inclusion Criteria:

* Female patients
* Symptoms of obstructed defaecation
* Planned for evacuation proctography

Exclusion Criteria:

* Inability to understand English
* Unwilling to consent for evacuation proctography
* Under 18 years of age
* Virgo intacta
Pragmatic Impact of Proteomic Risk Stratification in Diabetes Mellitus

Single-center, prospective, 2:1 randomized controlled parallel-group study, with an open label extension to evaluate SomaSignal Informed Medical Management (informed) versus Standard of Care (uninformed).

Primary Aim: To determine whether risk stratification from SomaLogic's Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) test leads to riskconcordant changes in prescriptions and/or medical management in patients with diabetes.

Secondary Aims:

Secondary Aim 1: To evaluate the perspectives of healthcare providers on the impact of SomaLogic's Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) test risk calculator in clinical practice.

Secondary Aim 2: To enable future health economic analyses of the impact of precision risk-stratified treatment.

Secondary Aim 3: In an open-label extension, to determine the impact of additional Metabolic Factor test results (beyond the SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D)) on medical management of the previously uninformed group at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving care at a University Hospitals location
* Patients 40-89 year of age
* Diagnosis of Type 2 Diabetes Mellitus
* Eligible for but not currently prescribed a SGLT2i or GLP1RA per drug label. This includes a diagnosis of type 2 diabetes plus established atherosclerotic cardiovascular disease or high risk for atherosclerotic cardiovascular disease (including age ≥55 years with coronary, carotid, or lower-extremity atherosclerotic disease) or heart failure or chronic kidney disease with or without albuminuria.
* Patients that are able to provide consent

Exclusion Criteria:

* Intolerance or contraindication for use of both GLP1RA and SGLT2i
* Use of SGLT2i or GLP1RA within the 3 months prior to enrollment
* History of, an active, or untreated malignancy, in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years prior to, or are receiving or planning to receive therapy for cancer, at screening
* Patients that have Systemic Lupus Erythematous (SLE)
* End-stage renal disease
* Pregnancy (as determined by self-report)
* Inability to understand English (since must be able to understand risk report which is not translated by the manufacturer)
The Effect of New Dentifrices Containing Centella Asiatica and Bamboo Salt on Reducing Plaque and Gingivitis

This study aims to evaluate the effect of dentifrice formulations containing Centella asiatica and bamboo salt on gingivitis and dental plaque. Participants uses dentifrice which contains Centella asiatica and bamboo salt and the same participants will also use placebo for tooth brushing by cross-over design.

With growing interest in plant-based products among researchers, many toothpastes with various herbal extracts have been introduced over the past few decades,Centella asiatica (CA), a small herb broadly cultivated in China, Southeast Asia, India and Oceanic countries, has long been used for therapeutic purposes since ancient times.CA has been reported to be useful in the treatment of skin diseases wound repair and healing of burn. In dentistry, few studies have explored the efficacy of CA. In one study, CA was demonstrated to be an effective supportive agent following periodontal treatment, resulting in reduced plaque and gingivitis. In spite of such wound healing properties of CA, its usage in dental field has been limited.

Bamboo salt (BS) is a Korean folk remedy consisting of sea salt roasted in bamboo which has long been used for therapeutic purposes in Korea. Toothpastes containing BS has been sold in Korea for some decades. Some in vitro studies and animal studies using rats demonstrated anti-inflammatory effects of BS. Nevertheless, no human study has yet evaluated the effect of BS on periodontal health.

Therefore, the new dentifrice containing CA and BS was developed.

Eligibility Criteria:
Inclusion Criteria:

* Systemical healthy individual
* Normal alignment of teeth

Exclusion Criteria:

* Recent antibiotic treatment
* Existence of dental caries or periodontitis
* Those needs emergency dental treatments
* Natural teeth less than 20
* Denture wearer
* Oral appliance for orthodontic treatment
* Pregnant
Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction

The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade® 4.0 during bilateral breast reduction; to monitor and record post-operative pain, adverse events and skin scarring following surgery; and to compare these outcomes to the HARMONIC SYNERGY® BLADE.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 70
2. Physically healthy, stable weight
3. No smoking \<1 month prior to surgery and during study.
4. Desiring bilateral breast reduction
5. Subject must understand the nature of the procedure and provide written informed consent prior to the procedure.
6. Subject must be willing and able to comply with specified follow-up evaluations.
7. Female subjects must either be incapable of reproduction, or taking acceptable measures to prevent pregnancy and have a negative pregnancy test prior to participation in the study.

Exclusion Criteria:

1. Age younger than 18 or greater than 70 years old
2. Anticoagulation therapy which cannot be discontinued
3. Smoking \<1 month prior to surgery or during study
4. Infection (local or systemic)
5. Cognitive impairment or mental illness
6. Severe cardiopulmonary deficiencies
7. Known coagulopathy
8. Immunocompromised
9. Prior history of breast cancer
10. Kidney disease (any type)
11. Currently taking any medication known to affect healing
12. Subjects who are status-post gastric banding or gastric bypass
13. Currently enrolled in another investigational device or drug trial
14. Unable to follow instructions or complete follow-up
Internet-based, Naturalistic Evaluation of Tolerability and Individual Patient Target Pressures With Bimatoprost 0.03% in Glaucoma

The purpose of this study is to evaluate the range of target IOPs set for glaucoma patients starting monotherapy with bimatoprost and to evaluate patient and physician satisfaction with bimatoprost in "real-world" settings


Eligibility Criteria:
Inclusion Criteria:

* Patients with either open-angle glaucoma or ocular hypertension were eligible if they needed bilateral IOP reduction beyond what was achieved with their current medication, or if they were intolerant of other IOP-lowering medications.
Er:YAG Laser Effects on Microbial Population in Conservative Dentistry

The aim of this study is to verify the quantitative and qualitative effect of Erbium dental laser therapy on microbial populations in carious lesions and to compare the laser therapy with traditional conservative therapies.

Patients will be assessed and selected at the University Odontostomatology Clinic (COU) in Perugia; patients are considered eligible for enrolment if they are at least 18 years old and have a carious lesion on permanent teeth, cavitated and non-destructive, deepening to the middle third of the dentine and no further. The patients will be randomly assigned to two groups as follows: group A, control group, which includes treatment with traditional therapy; group B, intervention group, which includes treatment with Er:YAG laser therapy. For each patient, two salivary swabs will be taken on the cavity dentine of the carious lesion: one before and one after the treatments.

Eligibility Criteria:
Inclusion Criteria:

- Adult patients of both sexes with at least 18 years of age and one cavitated non-destructive carious occlusal lesion of a permanent teeth, that deepens up to the middle third of the dentin and not beyond, confirmed by radiographic exam and without pulp involvement.

Exclusion Criteria:

* patients that refused to sign the informed consent document;
* children or individuals with less than 18 years;
* pregnant subjects;
* patients with syndromes or chronic systemic diseases;
* patients who had used antibiotics within the previous three months or under pharmacological treatments;
* patients with painful symptoms consistent with irreversible pulpitis or mobility and destructive carious lesions extending beyond the middle third of the dentin;
* teeth with exposure of the dental pulp or periodontitis;
* patients with caries on deciduous teeth;
* patients with no cooperation during the radiographical exam and/or treatments.
A Natural History Study of Molybdenum Cofactor and Isolated Sulfite Oxidase Deficiencies

Primary objective:

Characterize the natural history of MoCD type A in terms of survival

Secondary objectives:

1. Evaluate blood and urine for biochemical markers
2. Evaluate head circumference, seizure activity and neurologic outcomes
3. To evaluate brain MRI
4. Compare blood and urine analysis, head circumference, seizure activity and neurologic outcomes to MRI findings


Eligibility Criteria:
Inclusion Criteria:

1. Both living and deceased patients of any age will be considered for study inclusion.
2. Diagnosis of MoCD or isolated SOX deficiency
3. Documented informed consent

Exclusion Criteria:

1. MoCD Type A patient who was in Study ALX-MCD-501
2. Deceased patients with unknown genotype (as of Amendment 4)
Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel (TAK-700) plus prednisone compared with placebo plus prednisone in the treatment of men with progressive, chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC)


Eligibility Criteria:
Inclusion Criteria:

Each patient must meet all of the following inclusion criteria:

* Voluntary written consent
* Male patients 18 years or older
* Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma
* Radiograph-documented metastatic disease
* Progressive disease
* Prior surgical castration or concurrent use of an agent for medical castration
* Either absence of pain or pain not requiring use of any opioid or narcotic analgesia in the 2 weeks prior to study entry
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Even if surgically sterilized, patients must practice effective barrier contraception during the entire study treatment and for 4 months after the last dose of study drug, OR abstain from heterosexual intercourse
* Meet screening laboratory values as specified in protocol
* Stable medical condition

Exclusion Criteria:

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

* Known hypersensitivity to orteronel, prednisone or gonadotropin-releasing hormone (GnRH) analogue
* Received prior therapy with orteronel, aminoglutethimide, ketoconazole or abiraterone
* Received antiandrogen therapy within 6 weeks for bicalutamide and 4 weeks for all others prior to first dose of study drug
* Continuous daily use of oral prednisone or oral dexamethasone for more than 14 days within 3 months prior to study
* Received prior chemotherapy for prostate cancer with exception of neoadjuvant/adjuvant therapy as part of initial primary treatment for local disease that was completed 2 or more years prior to screening
* Exposure to radioisotope therapy within 4 weeks of receiving first dose of study drug; exposure to external beam radiation within 2 weeks of start of screening until receiving the first dose of study drug
* Documented central nervous system metastases
* Treatment with any investigational compound within 30 days prior to first dose of study drug
* Current spinal cord compression, bilateral hydronephrosis or current bladder neck outlet obstruction
* Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected
* Uncontrolled cardiovascular condition as specified in study protocol
* Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
* Unwilling or unable to comply with protocol
* Uncontrolled nausea, vomiting or diarrhea
* Known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of orteronel
An Artificial Intelligence System for ROSE of EUS-FNA Sample: a Prospective, Multicenter, Diagnostic Study.

This is an observational study with a prospective, multicenter, disgnostic design. An artificial intelligence system named ROSE-AI system was developed using cytopathological slide images taken by microscope camera or smartphone of pancreas, bile duct, liver and lymph node, collected retrospectively from patients who underwent EUS-FNA and ROSE, and the performance of ROSE-AI system was validated in the datasets collected prospectively.This study aims to assist endoscopists in conducting rapid on-site cytopathology evaluations during EUS-FNA without the presence of cytopathologists. In addition, the diagnostic field was compared between the cytopathologists and ROSE-AI system, endoscopists with or without ROSE-AI system.


Eligibility Criteria:
Inclusion Criteria:

1. the patient age ≥18 years accepted EUS-FNA+ROSE.
2. agree to participate in the research and be able to sign written informed consent.

Exclusion Criteria:

1. uncorrectable coagulopathy (PTT \>50 seconds or INR \>1.5) and/or uncorrectable thrombocytopenia (platelet count \<50 × 109 /L).
2. patients who were too clinically ill to undergo an EUS examination.
3. lesions that were deemed inaccessible for EUS-guided sampling.
4. unsuccessful EUS-FNA (e.g., failure to obtain an adequate specimen, patient intolerance, intraoperative accidents, etc.).
5. Patients with unqualified ROSE smear.
6. Patients who underwent biopsy during EUS-FNA but did not receive a definitive pathological diagnosis or pathological report.
7. pregnancy.