cyrilzakka/clinical-trials huggingface dataset:
SPA Therapy in the Treatment of Sleep Apnea Syndrome

The purpose of this study is to determine whether 3-week of SPA therapy improves sleep apnea in patients with chronic venous insufficiency and concomitant Obstructive Sleep Apnea Syndrome (OSAS).

Obstructive Sleep Apnea Syndrome (OSAS), characterized by repetitive episodes of partial or complete upper airway (UA) obstruction, is highly prevalent in the general population (2% in women, 4% in men). OSAS is associated with hypersomnolence and it increases the risk of cardiovascular morbidity and mortality. Its pathogenesis is largely multifactorial. In patients with chronic venous insufficiency, fluid retention contributes to this pathogenesis: during the day, fluid accumulates in the legs due to gravity ; during sleep in recumbent position, this accumulated fluid redistributes rostrally in the neck and causes upper airway narrowing and predisposes to OSAS.

The hypothesis is that a comprehensive treatment program for chronic venous insufficiency (SPA therapy) would reduce sleep apnea in patients with chronic venous insufficiency and concomitant sleep apnea Syndrome.

The objective is to assess the efficacy of a 3-week SPA therapy on attenuation of sleep apnea in this population of patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient with Chronic Venous Insufficiency with oedema (CEAP clinical classes C3 to C5) and concomitant Sleep Apnea Syndrome (AHI \> 15 events/hour)
* Patient in stable state (no change in medical treatment and no hospitalization for respiratory, cardiac or metabolic event in the 2 months preceding inclusion)
* Patient available for a program of 3-week SPA Therapy

Exclusion Criteria:

* Patient with no social insurance
* Pregnant and nursing woman
* Patient detained by judicial order
* Patient with contra-indication to SPA therapy
* Patient with chronic venous insufficiency \< CEAP C3 or CEAP C6
* Patient already treated by class IV compression stockings for severe veinolymphatic insufficiency
* Patient already treated for sleep apnea
* Patient who have already benefited of SPA therapy (any type) within 9 months before the enrollment
* Patient with severe comorbidities
* Patient who could not respect the constraints related to the study
Association of Carbamylated HDL and CAD in T2DM Patients

This is an observational cross-sectional study aimed at investigating the alterations of the carbamylated-HDL levels in T2DM patients, and comparing the concentration of carbamylated-HDL between the T2DM patients with CAD and without CAD to explore the association between carbamylated-HDL and risk of CAD in T2DM patients.

High-density lipoprotein (HDL) is involved in various atheroprotective processes, including reverse cholesterol transport, inhibition of lipid oxidation and inflammatory cytokine secretion, endothelial repair, and antiapoptotic function, which all contribute to the regression of plague burden. Recent studies have shown that oxidative stress and chronic inflammation - both implicated in the process of diabetes - can contribute to an irreversible post-translational modification called carbamylation. Carbamylation levels reflect the burden of enhanced inflammation, oxidative stress, and renal impairment, and can serve as a biomarker of certain pathological conditions. Several clinical studies have demonstrated positive associations between cardiovascular risk, mortality, and serum carbamylation-derived product levels in the general population and particularly in patients with kidney failure. Increasing evidence also shows that carbamylated lipoprotein plays a pivotal role in atherosclerosis.18 However, most studies concerning carbamylation have been performed under a kidney disease background. Whether HDL particles in patients with type 2 diabetes mellitus (T2DM) show enhanced carbamylation and whether this enhancement is associated with vascular complications remains unknown. Thus, in the present study, the investigators aim to test whether HDL experiences carbamylation in T2DM patients and investigated the pro-atherogenic effects of carbamylated HDL on endothelial-monocyte adhesion.

Eligibility Criteria:
Inclusion Criteria:

1:Clinical diagnosis of T2DM (according to the criteria of the American Diabetes Association.)

Exclusion Criteria:

1. end-stage renal disease (ESRD)
2. acute coronary syndrome,
3. heart failure,
4. chronic viral or bacterial infection,
5. cancer,
6. immune system disorders
Risk Factors Associated With Recurrence and Life-threatening Complications for CSOJ

Clinically, recurrence and life-threatening complications are challenging problems for chronic suppurative osteomyelitis of the jaw. There is no quantitative analysis or report about the causes of or risk factors for the two problems. Doctors identify the causes or risk factors only through clinical experience. The investigators performed a retrospective study of 322 patients with chronic suppurative osteomyelitis of the jaw. The risk factors for the above mentioned two problems were analyzed by logistic regression analysis. The investigators found that some of the patients' general conditions, including age, admission temperature, admission white blood cell count, pre-admission antibiotic administration without consultation, location of the lesion, and general patient condition, were the risk factors. The results indicate that doctors should be mindful of those risk factors and that the management should be more aggressive when the above risk factors are present.

This is a retrospective study of 322 patients hospitalized with CSOJ. The socio-demographic and clinical characteristics were recorded. The risk factors for the above two problems were analyzed by logistic regression analysis. Frequency and percentage were used to indicate descriptive research factors. A univariate logistic regression analysis was performed to calculate the odds ratio (OR) and to identify preliminary risk factors. The preliminary risk factors were further identified by multivariate logistic regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis on admission was made on the basis of the presence of sequestra and laminations of periosteal new bone in the pathological area.
* The other diagnostic criteria is that symptoms such as local pain, pyorrhea, fever, swelling, fistula, neuropalsy, odontoseisis, lymphadenopathy, bromopnea, and trismus pain are unresponsive or insensitive to conservative therapy and simple debridement.

Exclusion Criteria:

* Patients without confirmed evidence of CSOJ and (or) without standard treatment (a combination of antimicrobial therapy and surgery consisting of incision and drainage, debridement or sequestrectomy) were excluded.
* Paget's disease, hypercementosis, fibrous dysplasia, and early stage malignant bone tumor were differentially diagnosed and excluded.
Evolution of PET Fixation With FDG at the End of Antibiotic Treatment of Infective Endocarditis on Valvular Prosthesis

In patients with prosthetic valve endocarditis (PVE) and pathological valvular FDG uptake on the initial FDG-PET and not referred to valve replacement at the acute phase, the study will assess whether FDG-PET is able to identify those at increased risk of PVE relapse.

In patients medically treated for prosthetic valve infection (PVE), identification of persistent infection or of cure could be very useful to 1/ patients referral to high-risk surgery, 2/ initiation of suppressive antibiotic therapy, or 3/ simplify the follow-up in other patients. The hypothesis is that FDG-PET could thus identify patients at increased risk of recurrence in case of persistent pathological uptake In patients with prosthetic endocarditis and pathological valvular FDG uptake on the initial FDG-PET and not referred to valve replacement at the acute phase, the main objective is to estimate the proportion of those still showing pathological valvular FDG uptake after curative antibiotic treatment. The secondary objectives are 1/ to quantitatively compare the valvular FDG-PET uptake for each individual before and after treatment; 2/ to determine the proportion of those in whom extracardiac foci persist at the end of treatment ; 3/ to evaluate the association between valvular FDG uptake on PET at the end of treatment and PVE relapse at 6 months; 4/ to evaluate the diagnostic performance of an automatic analysis by artificial intelligence of FDG uptake before and after treatment to predict PVE relapse at 6 months.

This is a single-center prospective cohort study. The population is composed of 50 adults with definite PVE according to the ESC 2015 classification, not operated in the acute phase and with pathological FDG-PET at the beginning of curative antibiotic treatment.

A change in practices regarding the duration of antibiotic therapy and the use of valve replacement surgery and its potential complications would benefit patients and reduce the overall cost related to valve prosthesis infection to the healthcare system."

Eligibility Criteria:
"Inclusion criteria:

* Patient aged 18 or over;
* Have a prosthetic valve implanted surgically or by catheter for at least 3 months;
* Presenting a definite IE on a prosthetic valve (ESC definition in force);
* Having benefited from an FDG-PET examination for diagnostic purposes as part of the treatment revealing pathological hyperuptake at the level of the prosthetic valve AND carried out \<15 days after the start of antibiotic therapy for infective endocarditis;
* Absence of cardiac surgical intervention performed for the current episode of AE or planned before the end-of-treatment FDG-PET

Exclusion criteria:

* Patient under legal protection, guardianship or curators;
* Pregnancy, breastfeeding;
* Patient not affiliated to a health insurance scheme or not a beneficiary of a social security scheme;
* Simultaneous participation in a study on FDG-PET;
* Absence of informed consent signed by the patient."
"Remind to Move" Treatment Versus Constraint-induced Movement Therapy for Children With Hemiplegic Cerebral Palsy

The aim of this study was to determine the effects of an innovative child-friendly remind-to-move treatment (RTM) treatment by comparing it with constraint-induced movement therapy (CIMT) on upper extremity outcomes in children with hemiplegic Cerebral Palsy. In an evaluator-blinded randomized controlled trial, 73 children, among of whom 20 in Manual Ability Classification System level I, 38 level II, and 15 level III, were recruited from 3 special schools and randomized to receive 75-hour RTM (n=25) and CIMT (n=24) programme over 15-weekdays, and conventional treatment (n=24). The primary outcomes were Jebsen-Taylor Hand Function Test (JTHFT) and Bruininks-Oseretsky Test of Motor Proficiency (BOTMP-II) Subtest 3 for assessing the motor efficiency at baseline, posttest, and 1- and 3-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Hemiplegic Cerebral Palsy
* Aged 5 to 16 years
* Ability to follow instructions
* Ability to grasp and release light objects, and at least 20° wrist and 10°fingers in metacarpophalangeal joints extension from full flexion for the affected hand
* Manual Activity Classification System (MACS) 19 grades I, II or III of the affected hand

Exclusion Criteria:

* Severe cognitive, visual, or auditory disorder
* Seizure and health problems not associated with cerebral palsy
* Predominant spasticity or contracture grades more than 3 of Modified Ashworth Scale 20 on wrist and finger flexors, forearm pronators and ⁄ or thumb adductors
* Receiving new pharmaceutical (i.e. botulinum toxin injections) and/or surgical interventions within 6-month before study
Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution

In this pilot study, APR-TD011 antimicrobial wound cleansing spray will be given to all enrolled patients with junctional EB (JEB) or dystrophic epidermolysis bullosa (DEB) with Staphylococcus aureus or Pseudomonas aeruginosa culture-positive wounds. The primary aim will be to evaluate the change in skin microbiome (S. aureus, P. aeruginosa, commensal organisms) before, during, after treatment. Subjects who are colonized by S. aureus or pseudomonas will be treated for 8 weeks, will stop the spray and return at 12 weeks (4 weeks without the spray), and then will be able to use the spray as desired in a 6-month period of open-label use, with further feedback collected.


Eligibility Criteria:
Inclusion Criteria:

* Patients 6 months of age or above with junctional or dystrophic epidermolysis bullosa
* Target wound that has been present for at least 3 weeks and is at least 10 cm2
* Target wound that is colonized with Staphylococcus aureus and/or Pseudomonas aeruginosa

Exclusion Criteria:

* Patients currently or recently (within past 4 weeks) on topical or systemic antibiotics
* Do not agree to avoid bathing or topical application at the target starting the night before the visit.
* Do not agree to avoid dilute bleach or vinegar baths, or other antiseptic use, at the target site starting at screening throughout the study.
Comparison the Hemodynamics Effects Between Dexmedetomidine and Propofol in Major Abdominal Surgical Patients

The alpha2 agonist dexmedetomidine is a new sedative agent combined with the analgesic qualities and lack of respiratory depression. Patients sedated with dexmedetomidine could be easily roused, these advances shows dexmedetomidine may be a effective and safe sedative agent. But some studies showed some adversely effects of dexmedetomidine on haemodynamics (such as bradycardia, hypotension), the investigators want to further research the effects of dexmedetomidine on haemodynamics, such as Cardiac Output (CO), Systemic Venous Resistance Index(SVRI), and so on. Propofol is widely used sedative agent in ICU, it also has adversely effects like bradycardia and hypotension, so the investigators want to compare the effect of dexmedetomidine with propofol on haemodynamics after major abdominal surgery. Expect to further research the mechanism of haemodynamics of dexmedetomidine.

When the patients can be roused, they will first receive analgesia with bolus of fentanyl 0.03mg, followed by a continuous infusion at a ﬁxed dose of 0.3μg/kg/h during study period. Then patients will be randomly divided into two groups (Dexmedetomidine and Propofol). All of them will receive hemodynamic monitoring through "Vigileo"(Edwards Lifesciences) and cardiogram monitor. The study will continue for 6-24 hours.

Eligibility Criteria:
Inclusion Criteria:

1. Postoperative patients of major abdominal surgery
2. Age ≧ 18

Exclusion Criteria:

1. heart rate ≤ 50 bpm
2. allergy with dexmedetomidine or propofol
3. pregnancy
The Effectiveness of Eptinezumab During a Migraine Attack (the BE-FREE Study): a TACHIS Sub-study

A perspective and multicentric study to evaluate the efficacy of eptinezumab administered during a migraine attack. During the intravenous infusion of eptinezumab, some patients experiencing an ongoing migraine attack report its resolution. This finding is known in the literature, having been described in the RELIEF study. This study was designed to also evaluate, in a real-world setting, the efficacy of eptinezumab in resolving the ongoing attack and the time frame within which the attack is resolved.

The study includes all patients who will begin treatment according to clinical practice, and are included in the TACHIS study (NCT06409845, Unique protocol ID RICe_5)


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the third edition of the ICHD (ICHD-III).
* At least 8 days of migraine per month.
* Adequate compliance with study procedures.
* Availability of a migraine diary for at least one month prior to enrollment.
* Ongoing attack before administration.
* Included in the TACHIS study (NCT06409845)

Exclusion Criteria:

* Subjects with contraindications to the use of eptinezumab.
* Concomitant diagnosis of medical conditions and/or comorbidities that, in the investigator's opinion, could interfere with the study's assessments and outcomes.
* Pregnancy and breastfeeding.
* Changes in concomitant preventive therapy in the month prior to the initiation of eptinezumab.
The Effect of Night Eye Mask on Post-operative Pain in Cardiac Surgery Patients

Environmental factors such as noise and light have been cited as important causes of sleep deprivation in Intensive care unit (ICU) patients. Previous studies demonstrated a hyperalgesic alteration in pain perception following a controlled sleep deprivation protocol. Another studies indicated that using eye masks can improve REM sleep in healthy subjects in simulated ICU environment, and improve sleep quality in ICU patients. This study aimed to determine the effects of using eye masks on sleep and thus on pain quality in postoperative cardiac surgery patients in ICU.


Eligibility Criteria:
Inclusion Criteria:

* (1) age ≧18 years; (2) no history of neurological or psychiatric disorders; (3) ability of patients to communicate verbally and understand the sleep questionnaires administered in the ICU; (3) length of ICU stay ≥48 hours; (4) Glasgow coma score (GCS) \>8 in the first to third day. Postoperative Extubation of MV within few hour (before the time of 9 pm for postoperative patients.

Exclusion Criteria:

* Patients over age 65 were excluded from the study because of potential age-related differences in sleep. Patients reporting frequent nighttime awakenings, snoring, or chronic use of benzodiazepines or opioids were excluded because of potential confounding influences of these factors on postoperative sleep, pain, or opioid requirement.
Driving Performance After Deep Sedation for Outpatient Endoscopy

Many drugs used during anesthesia can reduce alertness and therefore present potential risks when driving a vehicle (risk of accident). Some scientific societies recommend not driving for 12 to 24 hours after sedation or general anesthesia. However, there are conflicting data in the literature showing that general anesthesia in healthy volunteers does not impair driving ability as early as 2 hours after the end of anesthesia.

This need not to drive requires the outpatient to have an escort. Unfortunately, some patients find it difficult to benefit from an adult escort, which can lead to last minute cancellations, absences or the need for a classic overnight hospital stay.

The main objective of the study is to compare with a simulator the driving performances of patients who have benefited from deep sedation for an outpatient endoscopic digestive procedure when they have met the discharge criteria to the performances of their escorts in order to determine if the conditions are as safe to let them drive home.


Eligibility Criteria:
Inclusion Criteria:

* Presence of a driver license

Exclusion Criteria:

* Unavailabilty of the escort for the duration of the examination
* No driving for the past 5 years
* Refusal of participation
Effect of Virtual Reality Application on Pain, Anxiety and Comfort During Chest Tube Removal Procedure

Chest tubes are used to eliminate possible acute or chronic problems that may occur after trauma or surgical interventions to the chest area. This process, which aims to drain the fluid, blood or air accumulated in the pleural area, works with the support of closed underwater drainage systems. The chest tubes, which remain in place for a long time, fuse with the endothelium lying in the chest cavity. For this reason, the adhesions formed with the fusion cause very severe acute pain in the patient with the pulling force applied during removal.The high level of pain of the person will cause an increase in the level of anxiety and a decrease in the level of comfort. The anxiety experienced by the patients will also reduce the tolerance to pain.It has been observed that the use of virtual reality in the field of health significantly reduces the level of pain and anxiety during medical procedures, shortens wound healing and hospital stay, and increases compliance with treatment.In the literature, no studies were found in which the effects of virtual reality application on pain, anxiety and comfort were evaluated in patients whose chest tube was removed.Thereforee, this study was conducted to evaluate the effect of virtual reality application against all these negative situations.


Eligibility Criteria:
* Study Inclusion Criteria:

  * Must be between the ages of 18-65,
  * Must have undergone coronary artery bypass graft surgery and have a chest tube,
  * Must participate in the study voluntarily,
  * Must not have vision or hearing problems,
  * Must not have disorientation in place and time,
  * Must not have any psychiatric disorders,
* Study Exclusion Criteria:

  * Those with chronic pain and routinely using painkillers,
  * Those using painkillers before the procedure,
  * Those with problems such as migraine, vertigo, dizziness,
  * Patients using prescription glasses and those having vision problems without glasses were not included in the study.
Automated Parkinson's Disease (PD) Motor Symptom Assessment for Deep Brain Stimulation (DBS) Programming

The purpose of this study is to evaluate the utility of a portable motion sensor-based system designed to assist with deep brain stimulation (DBS) programming sessions for Parkinson's disease patients.


Eligibility Criteria:
Inclusion Criteria:

* Hoehn and Yahr stage 2 or worse when off medications
* Average tremor and/or bradykinesia Unified Disease Rating Scale (UPDRS) score greater than 2 off meds
* L-dopa responsive with clearly defined "on" periods, UPDRS motor III average tremor and bradykinesia improves by 25%
* Stable on medical therapy for at least one month prior to study enrollment
* Clinical approval to undergo unilateral DBS surgery targeting the STN or GPi
* Available to participate for six months following DBS surgery

Exclusion Criteria:

* "Parkinson's plus" syndromes, secondary, or atypical Parkinson's syndromes (e.g. progressive supranuclear palsy, striato-nigral degeneration, multiple system atrophy, post-stroke, post-traumatic, or post-encephalitic Parkinson's. These patients have cardinal symptoms characteristic of PD but with additional symptoms indicating other organic brain dysfunction, such as gaze palsies, autonomic dysfunction, lack of response to L-dopa, these individuals tend not to improve with standard treatments for PD)
* previous Parkinson's Disease surgery
* medical contraindications to surgery or stimulation (e.g. uncontrolled hypertension, advanced coronary artery disease, other implanted stimulation or electronically-controlled devices including cardiac demand pacemaker, aneurysm clips, cochlear implants, or a spinal cord stimulator) (Note: for the subject who receives either a pacemaker and/or defibrillator after this study enrollment, he/she will be allowed to continue the study if the neurostimulator system can be adequately programmed to permit system compatibility)
* contraindication to magnetic resonance imaging (e.g. indwelling metal fragments or implants that might be affected by MRI)
* neuropsychological dysfunction (e.g. dementia) that would contraindicate surgery
* intracranial abnormalities that would contraindicate surgery (e.g. stroke, tumor, vascular abnormality affecting the target area)