cyrilzakka/clinical-trials huggingface dataset:
Intrathecal Magnesium for Same-day-surgery

5% hyperbaric lidocaine has lost its usefulness for same-day-surgery (SDS) anaesthesia because it has been blamed responsible for the so-called transitory neurological syndrome (TNS). This entity appears particularly in patients operated on lithotomy and knee arthroscopy position and obese patients. It is a benign, moderately painful (grade 3-4 out of 10) and self-limited in time, but disturbing enough to be avoided in same-day-surgery cases. Other local anesthetics are not competitive with general anesthesia in time to be discharged home from the SDS unit. The magnesium ion is well-known for its protective properties on cells with electrical activity. The objective is to confirm that the magnesium ion added as adjuvant to intrathecal (IT) lidocaine may antagonize TNS incidence. If this hypothesis could be confirmed, the practical and theoretical consequences would be far-reaching.

The method to achieve our objective would be a double-blinded randomized clinical trial considering two groups of intrathecal lidocaine: with and without added IT magnesium.


Eligibility Criteria:
Inclusion Criteria:

* Same day surgery patients
* Operated in lithotomy or arthroscopy position or obese patients

Exclusion Criteria:

* American Society of Anesthesia 3 or 4 patients
* Younger than 18 or elder than 80 years-old
* Active lumbar pain
* Any short of chronic neurologic disease
* Any short of myopathy
* Pregnant women
* Previous history of allergic or toxic reaction to lidocaine, magnesium or fentanyl
Implanted Loop Recorder Post Atrial Fibrillation Ablation

This is a pilot study to determine if implanted loop recorders can more effectively monitor atrial fibrillation recurrence after atrial fibrillation ablation.

Atrial Fibrillation (AF)is the most common arrhythmia and causes significant morbidity and mortality. Treatment for AF consists of medical therapy and ablation therapy. Medical therapies can help approximately 50% of patients, the rest must resort to ablation procedures.

Ablation procedures aim to isolate the pulmonary vein from the atrial tissue electrically and can be performed either endocardially through catheters inserted through the femoral veins or epicardially through a minimal lateral thoracotomy. Both procedures are accepted as standard of care.

Recurrent AF after ablation therapy can be common and occurs in 50% of patients and could be in a form of short periods of AF or persistent AF with less or minimal symptoms. This is of significant clinical relevance as most of these AF episodes are not recognized and can lead to thromboembolic events such as stroke. However, techniques of surveillance of AF post ablation have been suboptimal. Physicians could use holter monitoring but this is limited to a short period of 24 - 48 hours. Event recorders which are external can be used but patients need to experience symptoms associated with the AF episodes in order to record the episodes.

Better AF monitoring techniques especially after AF ablation are necessary so that recognition of AF recurrence in these patient could be possible and timely anticoagulation therapy initiated may prevent strokes.

This pilot study involves implanting a loop recorder just under the skin to record cardiac rhythms 24 hours per day without any interaction by the patient. These devices are currently approved by the FDA for monitoring of syncope and will be implanted during the patients AF ablation surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgical atrial fibrillation ablation
* Patients must be 18 years or older

Exclusion Criteria:

* Patients unwilling to comply with the follow up schedule
* Pregnant or breastfeeding patients
* Patients currently participating in another study
Pharmacodynamics Study of Imipenem in Patients With Ventilator Associated Pneumonia

Imipenem is a carbapenem antibacterial agent with a broad spectrum of activity against Gram-negative and Gram-positive bacteria. This agent is often used as the last line of therapy for highly resistant Gram negative bacilli nosocomial infections. In common with other beta-lactamase inhibitor, the main pharmacokinetic/pharmacodynamic (PK/PD) index that correlates with the therapeutic efficacy is the time that concentrations in the tissue and serum are above the MIC and administration by continuous infusion is the preferred mode of administration to maximize this parameter.

However, in tropical countries, the stability of carbapenem antibiotics is an important consideration when considering continuous infusion. Therefore, prolonged infusion may be a useful mode of administration to maximize bactericidal activity. This study will demonstrate the stability of imipenem in clinical use at room temperature in tropical countries.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged \> or = 20 years
* Patients who have VAP with Gram negative bacilli infections which are sensitive to imipenem by the disk diffusion

Exclusion Criteria:

* Patients who have documented hypersensitivity to imipenem or other carbapenems
* Patients who have an estimated creatinine clearance of \< or = 60 ml/min
* Patients who are in circulatory shock
* Patients who are pregnant
Difference in Grades of Epiblepharon According to Positional Changes and General Anesthesia

Epiblepharon is a very common condition among Asian children and is a fold of the skin and underlying pretarsal orbicularis muscle that overlaps the eyelid margin and pushes the lashes against the cornea. It is manifested by the anterior lamella overriding the posterior lamella which causes the lashes to brush against the cornea. Although the prevalence of epiblepharon is known to be high among Asians, its cause remains controversial. Several etiological factors may be involved in the pathogenesis of epiblepharon.

Although epiblepharon in the lower lids lessens and disappears with age in many cases, surgery must be performed at an early age in severe cases in order to prevent ocular trauma as the vertically oriented cilia of the lashes can erode the corneal epithelium. Induced keratitis and astigmatism are indications for surgical intervention.

Over our many years of surgical experience, the investigators came to realize that the severity of epiblepharon was reduced when patients were under general anesthesia during surgery. The purpose of this study was to investigate the role of the orbicularis muscle in the pathogenesis of lower lid epiblepharon and to analyze the differences in the severity of epiblepharon in the upright versus the supine position and before and after the induction of general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* subjects younger than 12 years
* more than 12 months' follow-up
* subjects demonstrating prominent corneal touch by cilia and/or related subjective symptoms
* subjects who underwent general anesthesia for surgical correction of epiblepharon

Exclusion Criteria:

* subjects older than 12 years
* less than 12 months' follow-up -. subjects who underwent surgery on local anesthesia
Effects of Botulinum Neurotoxin Type A (BoNT/A) Free of Complexing Proteins in the Spastic Equinovarus Foot

Clinical randomized clinical trial to assess the effectiveness on walking speed of repeated use of botulinum neurotoxin type A (BoNT/A)in the post-stroke spastic equinovarus foot in three successive infiltrations at 6-month intervals, checking if the sustainability of the effect is greater in incobotulinumtoxin A (Xeomin®) than in onabotulinumtoxinA (Botox®).

Spasticity is present in 38% of patients at six months after stroke. Equinovarus foot, with or without claw toes and striatal foot, is especially common. There is a weak to moderate evidence in favor of the use of botulinum neurotoxin type A (BoNT/A) in the equinovarus foot, stiff-knee and in other patterns that may interfere with gait ability. Specifically, BoNT/A increases walking speed in stroke patients with spastic equinovarus foot.

Repeated use of BoNT/A may lead to the appearance of neutralizing antibodies, so its effect may decrease over successive infiltrations. Among the differential characteristics of incobotulinumtoxinA (Xeomin®) there is a reduced inactivated botulinum neurotoxin content and the lack of complexing proteins, which would diminish antigenicity and not suppose a decrease of the effect before successive infiltrations.

The objective of this project is to determine the effect on walking speed of repeated use of BoNT/A in post-stroke spinal equinovarus foot in three consecutive injections at 6-month intervals and to investigate whether the sustainability of the effect is greater in incobotulinumtoxinA (Xeomin®) than in onabotulinumtoxinA (Botox®). All patients will receive 200-300 units of BoNT/A (Xeomin ® or Botox ®) that will be distributed according to the individual clinical pattern of spastic equinovarus foot.

Eligibility Criteria:
Inclusion Criteria:

* First-ever Ischemic or haemorrhagic stroke
* Time since stroke onset: \>6months
* Hemiparesis with equinovarus foot
* No previous BoNT/A

Exclusion Criteria:

* Non-ambulant patients
* Medical contraindications for BoNT/A use that appear in the product information sheet
Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation

The objective of this trial is to compare the safety, the efficacy and the cost-effectiveness of 2 therapeutic strategies (optimal standard of care therapy alone versus percutaneous MitraClip procedure and optimal standard of care therapy) in patients with severe secondary mitral regurgitation.

This trial is a French, multicenter and randomized trial. Patients enrolled will be clinically followed for 2 years (phone call at 1 month, clinical visit at 6 months, 12 months and 24 months).


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Severe secondary mitral regurgitation characterised, according to the European guidelines and recommendations, by a regurgitant volume\>30 mL/beat or an effective regurgitant orifice\>20 mm².
* New York heart Association Class≥ II.
* Left ventricular ejection fraction between 15% and 40%
* Minimum of 1 hospitalization for heart failure within 12 months preceding randomization
* Optimal standard of care therapy for heart failure according to investigator.
* Not eligible for a mitral surgery intervention according to the Heart Team.
* Willingness to participate in the study and signed written informed consent
* Affiliation to a health insurance system or a similar system

Exclusion Criteria:

* Eligible for a mitral surgery intervention according to the Heart Team.
* Primary mitral regurgitation.
* Myocardial infarction or coronary bypass grafting surgery within three months prior to randomization.
* Cardiac resynchronization therapy within three months prior to randomization.
* Cardioversion within three months prior to randomization
* Transcatheter aortic valve implantation within three months prior to randomization
* Need for any cardiovascular surgery (including registration on cardiac transplant list).
* Coronary angioplasty within one month prior to randomization.
* Previous surgical mitral valve repair.
* Renal replacement therapy.
* Active infection requiring current antibiotic therapy.
* Severe hepatic insufficiency.
* Stroke within three months prior to randomization.
* Concurrent medical condition with a life expectancy of less than 12 months.
* Uncontrolled arterial hypertension.
* Hypersensitivity to nitinol.
* Participation to another trial.
* Pregnancy.
* No affiliation to a health insurance system.
* Legal protection measure (guardianship or curatorship)
A Phase 1 Study of Duvelisib in Patients With Advanced Hematologic Malignancies

The purpose of this study is to determine the safety, maximum tolerated dose and pharmacokinetics of IPI-145 in patients with advanced hematologic malignancies.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age;
* Progressed during, refractory to, intolerant of, or ineligible for established therapy, or has a disease with no established therapy with the exception of expansion cohort of treatment naïve CLL patients;
* An Eastern Cooperative Oncology Group (ECOG) score of 0 to 2.

Exclusion Criteria:

* Any previous treatment with a PI3K inhibitor (Escalation Phase only) or within 4 weeks of the start of IPI-145 administration (Expansion Phase);
* Patients with overt leptomeningeal leukemia or CNS lymphoma;
* Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2.5 x upper limit of normal (ULN); direct bilirubin \>1.5 x ULN;
* Inadequate renal function defined by serum creatinine \> 1.5 x ULN
Hamstrings X Patellar Tendon for ACL Reconstruction in Soccer Players - RCT

The purpose of this study is to specifically evaluate outcomes of bone-patellar tendon-bone autograft versus hamstring autograft ACL reconstruction in soccer players.

A number of techniques for ACL reconstruction have been proposed and tested, and most surgeons now prefer autografts with the patellar tendon or semitendinosus tendon. The functional outcome after ACL reconstruction with the patellar or semitendinosus tendon has been a recent area of interest. Soccer is the most popular sport worldwide with more than 260 million active players, and it is hard to say if patellar tendon or semitendinosus grafts have different outcomes.

The purpose of this study was to specifically evaluate outcomes of bone-patellar tendon-bone autograft versus hamstring autograft ACL reconstruction in soccer players. The hypothesis of this study was that hamstring autograft ACL reconstruction would provide no statistically significant differences in patient-reported outcome scores, postoperative level of sports function, and harvest-site morbidity when compared with patellar tendon autograft .The Cincinnati Knee Rating System (CKRS) was chosen as the primary outcome. As secondary outcome, reruptures.

Between march 2016 and march 2017, 60 soccer players will be operated. The investigators consider as soccer players those who play more than 4 times a week. Once included in the study, they will be randomized in two groups: "hamstring group" and "patellar tendon group".

The final clinical evaluation with two years. For both groups, the technique is the same, the fixation of the grafts with metal interference screws. Femoral tunnel will be drilled with outside-in technique. The tibial tunnel with conventional 55 degrees guide.

Both groups of patients will receive the same physical therapy protocol. Data will be evaluated with the SPSS software for Windows (version 13.0).

Eligibility Criteria:
Inclusion Criteria:

* unilateral ACL lesion
* skeletally mature patients with closed physis
* no previous surgery on the affected knee (except for arthroscopic meniscectomy)
* less than 1 year from injury
* no associated ligament injuries (except for the medial collateral ligament grade I and II)
* soccer players.

Exclusion Criteria:

* morbid obesity
* degenerative changes in arthroscopy or image exams
* those who play soccer less than 4 times / week
Validation of the "ApneaScan" Algorithm for the Detection of Sleep Disordered Breathing in Chronic Heart Failure

A prospective observational multi-centre study for the validation of the ApneaScan algorithm (integrated in ICD devices (with or without cardiac resynchronization therapy function) of the "Incepta" series for the screening of sleep disordered breathing in patients with stable symptomatic chronic heart failure, using portable polygraphy monitoring device ("Embletta Gold") as reference for the Apnea-Hypopnea-Index (AHI).

Secondary objectives are the detection of severe sleep disordered breathing in patients with clinically indicated in-laboratory polysomnography, as well as correlations of the AHI detected by ApneaScan with other clinical endpoints like mortality, hospitalization, atrial fibrillation and ventricular arrhythmia.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Patient´s written informed consent
* Patients with a cardiac rhythm management device (ICD with or without cardiac resynchronization therapy function) of the "Incepta" series (including the ApneaScan algorithm) already implanted for at least 8 weeks (corresponding to the duration of the leads´ healing process); in order to standardize the enrollment period, inclusion should be effected between the first (the earliest 8 weeks after implantation) and the second routine control of ICD-function (the latest 9 months after implantation)
* Stable symptomatic chronic heart failure for either ischemic or non-ischemic reason (moderately to severely impaired systolic left ventricular function with NYHA-class II to III) under optimal pharmacological treatment (according to guidelines 2012 of the European Society of Cardiology)

Exclusion Criteria:

* Unstable heart failure (NYHA-class IV) or asymptomatic chronic heart failure (including patients with very mild exercise induced dyspnea, i.e. NYHA-class I)
* Patients already treated for sleep apnea syndrome (i.e. continuous positive airway pressure mask) or chronic obstructive pulmonary disease with GOLD-class IV (i.e. long-term oxygen therapy)
* A limited AHI detection by the ApneaScan algorithm until the planned inclusion (randomly defined by \<50% of countable AHI detection-points within the last 2 weeks).
* Patients with limited mobility due to orthopedic, neurologic or oncologic diseases (because of restricted assessment of exercise induced dyspnea)
* Patients on dialysis (either acute or chronic)
* Alcoholism or regular intake of hypnotics
* Pregnancy and lactation
Detection of Cytomegalovirus Virus in Neonates

To evaluate the illumigene CMV assay, using the illumipro-10 with neonates (up to 21 days of age) saliva swabs


Eligibility Criteria:
Inclusion Criteria:

* Saliva swab specimens from neonates up to 21 days of age
* Saliva swab sample placed in a nonnutritive transport medium or in a plastic sterile tube without medium.
* Flocked-nylon swabs

Exclusion Criteria:

* Samples other than saliva swab from patients up to 21 days of age.
* Swabs other than flocked-nylon.
* Swabs in a viral transport media not defined in the Investigational Use Only package insert
* Multiple specimens from the same patient.
* Specimens received in the laboratory in unsatisfactory containers or condition.
The Effect of Codeine on Driving Abilities

20 chronic pain patients using codeine are compared with 20 chronic patients not using opioids and 20 healthy volunteers with respect to driving ability measured by neurophysiological tests and driving in a car simulator.


Eligibility Criteria:
Inclusion Criteria:

* patients with chronic pain
* driving more than 50 000 km

Exclusion Criteria:

* addiction
* eyesight disorders
COMMunication and Education for the New CPAP Experience

The purpose of this research study is to examine the effect of a couple-oriented education and support intervention on patient- and partner -reported outcomes (positive airway pressure (PAP) adherence) in patients newly diagnosed with obstructive sleep apnea (OSA).

Continuous positive airway pressure (CPAP) therapy is an effective treatment for obstructive sleep apnea (OSA), but adherence is poor. CPAP adherence interventions to date have been met with limited success. Intervention strategies would be optimized by added support for patients and alternative strategies for intervention delivery. Significant others (SO) are likely to exert positive and negative effects on the patient's adoption and use of positive airway pressure (PAP) therapy and are frequently described as the greatest source of social support for patients with chronic illness. Beginning the intervention before PAP initiation would capitalize on the teachable moment shortly following diagnosis when education and social support may be most essential. The aims of the research plan are to examine the effects of a couple-oriented education and support intervention on patient- and partner-reported outcomes as compared to a patient-oriented education and support intervention and usual care and to examine the relationship between PAP adherence and patients' and partners' sleep quality and daytime functioning. Patients in the pilot study will be randomized to the couple-oriented intervention, patient-oriented intervention, or standard clinical care group.

Eligibility Criteria:
Inclusion Criteria:

Patient:

* Age is 21 years of age and older
* Have spouse or partner
* Polysomnographically (PSG) diagnosed OSA (AHI ≥ 5)
* Choice of continuous positive airway pressure (CPAP) as preferred treatment

Partner:

* Age is 18 years of age and older
* Have spouse or partner who has been diagnosed with OSA and has chosen CPAP as preferred treatment

Exclusion Criteria:

Patient:

* AHI \< 5 on the diagnostic PSG
* Have a spouse or partner with OSA diagnosis and on OSA treatment
* Past treatment for OSA
* Diagnosis of a sleep disorder other than OSA that cause arousals from sleep (e.g., central sleep apnea, periodic limb movement disorder, insomnia)
* Diagnosis of a serious medical condition (e.g., end stage renal failure, severe chronic obstructive lung disease, severe asthma)
* History of or current diagnosis of a major psychiatric illness except depression (e.g., schizophrenia, bipolar disorder) partner:
* Have been diagnosed with OSA and using CPAP
Digestion of Foods Consumed in Africa

As populations become urbanized in Africa, the change to a more Westernized diet has been associated with rise in obesity and related metabolic syndrome diseases. The current study shows that in the West African Sahel, these replacement starchy staple foods have fast gastric emptying compared to traditional sorghum and millet foods; and implies that the latter could be beneficial in lowering glycemic response, providing energy from a meal over a longer time, and providing a satiety effect. Knowledge of this attribute of sorghum and millet foods could be useful to improve their image in West African cities to increase their consumption and to improve markets for local smallholder farmers.

As suggested by anecdotal evidence that traditional Malian sorghum and millet foods are filling and provide sustained energy, we hypothesized that gastric emptying rates of sorghum and millet foods are slow, particularly compared to non-traditional starchy foods (white rice, potato, wheat pasta) that are now commonly consumed in urban areas of the West African Sahel. A broader purpose for the study was to understand whether sorghum and millet foods have positive health attributes that can be promoted in urban areas to provide better markets for local farmers.

Two human trials of similar design were conducted approximately one year apart. The carbon 13 (13C)-labelled octanoic acid breath test method was used to measure gastric emptying rate, and subjective pre-test and satiety response questionnaires were used. In the first study, 14 healthy volunteers in Bamako, Mali participated in a crossover design to test eight starchy foods for gastric emptying rate and satiety feelings. The second study with six volunteers was done to correct for endogenous 13C differences in the starch component of the foods.

Eligibility Criteria:
Inclusion Criteria:

* Normal body mass index (18 kg/m2 ≤ BMI ≤ 25 kg/m2)

Exclusion Criteria:

* Under any medication
* History of any gastrointestinal disease or surgery
* Diabetes
* Smoker