cyrilzakka/clinical-trials huggingface dataset:
A Study to Test Bioequivalence Between One Test Formulation of Ibuprofen and Two Reference Treatments

This study is designed to assess bioequivalence between one test and two reference formulations used for treatment of headaches and temporary relief of pain.

The study is a single dose, randomized, three-way crossover study in 30 healthy subjects, with equal numbers of males and females (minimum of 13 of either gender). Drop-outs will not be replaced. The three doses of medication given in the study (a single dose in each of the three study periods) will each be separated by a washout period of at least 7 calendar days. In each study period, eighteen (18) blood samples for pharmacokinetic analysis will be taken over 12 hours. Blood samples will be centrifuged and concentrations of ibuprofen (R-enantiomer and S-enantiomer) in plasma will be measured using a validated chromatographic assay. Pharmacokinetic parameters will be calculated from plasma concentration data \[R-enantiomer, S-enantiomer and total (sum of both enantiomers)\]. The rate and extent of absorption of the formulations will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects (equal numbers of males and females)
* Volunteers aged of at least 18 years but not older than 55 years
* Subjects will have a Body Mass Index (BMI) greater than or equal to 18.5 and below 30 kg/m2; and a total body weight \>50 kg
* Non- or ex-smokers; an ex-smoker being defined as someone who completely stopped smoking for at least 12 months before day 1 of this study.
* Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance
* Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, biochemistry, ECG and urinalysis)
* Has signed and dated the informed consent document, indicating that the subject has been informed of all pertinent aspects of the study
* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

* Seated pulse rate below 45 bpm or higher than 90 bpm at screening
* Seated blood pressure below 90/60 mmHg or higher than 140/90 mmHg at screening
* Relationship to persons involved directly with the conduct of the study (i.e., principal investigator; sub-investigators; study coordinators; other study personnel; employees or contractors of the sponsor or Johnson \& Johnson subsidiaries; and the families of each)
* Presence of any tongue piercings
* Presence of braces
* Females who are pregnant or are lactating
* Females of childbearing potential or males with a female partner of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the entire duration of the study
* Females who are pregnant according to a positive serum pregnancy test
* Any medical history or condition, or use of any drug or medication, that the investigator determines could compromise subject safety or the evaluation of results.
Attentional Bias Modification in Fibromyalgia Patients (ABM)

There is a growing interest in the potential benefits of attentional bias modification (ABM) training in chronic pain patients. However, studies examining the effectiveness of ABM programs in fibromyalgia patients have demonstrated inconclusive effects on both behavioral indices and clinical symptoms. Underlying neural dynamics of ABM effects could yield additional insights but remain yet unexplored.

Current study, therefore, aimed investigating the effects of ABM training on known neural indicators of attentional bias to pain using electroencephalography (EEG).

The goal of this clinical trial is to test the effects of ABM training on known neural indicators of attentional bias to pain using electroencephalography (EEG) in fibromyalgia patients

The main question\[s\] it aims to answer are:

* Are fibromyalgia patients sensitive to ABM procedures?
* What are the neural indices associated with ABM procedures?
* Do ABM procedures transfer of effects on the clinical symptomatology in fibromyalgia patients?

Participants will performes five sessions consisting of a modified dot-probe task in which patients were trained to avoid facial pain expressions, whereas in the control group participants will performes five sessions consisting of a standard dot-probe task. Potential ABM training effects will be evaluated by comparing a single pre- and post-treatment session, in which event-related potentials (ERPs) will be recorded in response to three experimental tasks (standard dot-probe, RIR, and visual tasks).

Furthermore, patients will fill a series of self-report questionnaires assessing anxiety, depression, pain-related worrying, fear of pain, fatigue and pain status.

Researchers will compare two fibromyalgia patients groups that will enrolled and randomly assigned to an ABM training in order to see attentional improvements in the training fibromyalgia group.


Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgia Diagnosis.
* Female sex
* The presence of clinical symptoms regarding anxiety or depression will be not exclusion criteria, as long as fibromyalgia was participants' primary diagnosis.

Exclusion Criteria:

* Participation in the study will require the absence of neurological and psychiatric disorders that impair cognitive functions (i.e., stroke brain damage, psychosis, bipolar disorder, and substance abuse/dependence).
* Pregnancy
* Not being able to read Spanish in order to fill in the questionnaires
Glottis Visualization in Different Lifting Methods

Among the various types of video laryngoscopes, the McGrath MAC video laryngoscopy (VL) has become popular because it is lightweight and can be quickly and hygienically prepared by changing the blade. The aim of this study was to compare the efficacy of two different methods (direct and indirect) for epiglottis removal during visualization of the glottis using the McGrath MAC VL.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* general anesthesia in elective surgeries
* 18-65 years old
* body mass index (25-30)
* no risk of difficult intubation

Exclusion Criteria:

* Allergic to study drugs
* pregnant women
* emergency cases
* those with a history of difficult intubation
* those without consent
* those at risk of aspiration
Study of the Prevalence of Cosavirus and Salivirus Infections, Two New Genera of Picornaviridae, In Infants

Cosavirus and Salivirus are two new genera of Picornaviridae and are responsible for acute diarrhoea. They have been identified in the pathological stools of infants and immuno-compromised subjects on every continent with prevalences ranging from 2.8% to 8.8% depending on the virus, the cohort and the country studied.

To date, no study on these two viruses has been conducted in France to evaluate the circulation and the pathogenicity of these viruses in subjects with diarrhoea.

The aim of this study is thus to:

* show that these viruses are in circulation in France in infants younger than 5 years old and that the proportions are similar to those reported in the literature.
* confirm the relationship between the diarrhoea and the infection with these viruses.


Eligibility Criteria:
Inclusion Criteria:

* Children younger than 5 years
* Children hospitalized or consulting at Dijon CHU during the 12 months of the study for acute gastroenteritis. Acute gastroenteritis is defined by at least 3 soft or liquid stools or at least 3 bouts of vomiting within 24 hours or signs (diarrhoea or vomiting) accompanied by at least 2 additional symptoms among diarrhoea or vomiting, abdominal pain, fever

for controls

* Children younger than 5 years old
* Children hospitalized or consulting at Dijon CHU during the 12 months of the study for any illness without diarrhoea (other than exclusion criteria).

Exclusion Criteria:

* Persons without national health insurance cover
* Children older than 5 years.
* Children presenting chronic diarrhoea (\> 2 weeks) (e.g. Crohn and UC)
* Children with immune deficiency.
* Children with nosocomial gastroenteritis; the nosocomial aspect will be defined as the onset of acute diarrhoea occurring after the 48th hour after admission

for controls

* Persons without national health insurance cover
* Children older than 5 years.
* Children with chronic diarrhoea (\> 2 weeks) (e.g. Crohn and UC)
* Children with immune deficiency.
Targeted Memory Reactivation During REM Sleep in Patients With Social Anxiety Disorder

With this study, the investigators aim to use sleep and dreaming in order to enhance exposure therapy for social anxiety disorder (SAD), by pairing the positive feedback phase of exposure (public talk) to an auditory stimulus during wake (associated sound) and subsequently applying this stimulus during sleep (targeted memory reactivation, TMR). Exposure therapy sessions will take place in a virtual reality (VR) environment, while physiological measures during the preparation phase of public talk such as heart rate variability (HRV), skin conductance response (SCR) and subjective level of anxiety (SUDS) will be used in order to assess treatment efficiency across the sessions. Patients with SAD according to DSM-5 criteria will be included.

The main hypothesis of this study is that participants who are presented with the associated sound during sleep (TMR group) will have reduced intensity of social anxiety compared to participants with no such association (control group), after both a full night's sleep with auditory stimulation during REM sleep in the laboratory, and after 1 week of stimulation during REM sleep at home. In addition, it is expected that fear-related dreams may correlate with anxiety levels during wakefulness after 1 week of stimulation at home.


Eligibility Criteria:
Inclusion Criteria:

* Patients with social anxiety disorder (according to DSM-5 criteria and Liebowitz Social Anxiety Scale \> 65)
* aged between 16 and 40 yo
* no current treatment for SAD (cognitive-behavioral therapy, medications)

Exclusion Criteria:

* mood disorder, psychosis,other anxiety disorder or other mental disorders according to DSM-5 criteria
* sleep disorder (e.g.,insomnia disorder, obstructive sleep apnea syndrome, restless legs syndrome) according to DSM-5 criteria
* use of psychiatric medication
* current treatment for SAD (cognitive-behavioral therapy, medications)
* neurological disease
Dermal Cryotherapy for Treatment of Pigmented Lesions

Study to evaluate the ability of the Dermal Cooling System to reduce pigmentation in benign pigmented lesions.

This study is a prospective, non-randomized, multi-center study of the Dermal Cooling System to verify that the device causes a reduction in pigmentation in benign pigmented lesions, and to determine at what parameters the device is most effective.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects \> 18 years of age.
2. Subject has one or more benign pigmented lesions (e.g., solar lentigines, melasma, freckles, café au lait, nevi, or hyperpigmentation), in an area suitable for treatment
3. Subject is willing to have up to 40 treatment sites and/or an area up to 8 square inches treated depending on the size and nature of the lesions identified.
4. Subject is willing to have digital photographs taken of the treatment area and agrees to use of photographs for presentation, educational, or marketing purposes.
5. Subject is willing to cover treated area or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treated areas for the duration of the study, including the follow-up period, if requested.
6. Subject has read and signed a written informed consent form.

Exclusion Criteria:

1. Physician prescribed medical or surgical treatment, or use of over-the-counter products to alter skin color, in the area of intended treatment in the previous 6 months (e.g., hydroquinone, corticosteroids, laser surgery)
2. Artificial tanning in the area of intended treatment within 1 month (e.g., spray, lotion, tanning bed) or intention to use artificial tanning within the follow-up period
3. Scars or tattoos in the location of the treatment sites
4. History of vitiligo, eczema, or psoriasis in the area of treatment
5. History of melanoma
6. Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease.
7. History of abnormal wound healing or abnormal scarring
8. Inability or unwillingness to comply with the study requirements.
9. Current enrollment in a clinical study of any other unapproved investigational drug or device.
10. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.
Added Value of O-RADS in Evaluation of Ovarian Lesions

To detect added value of O-RADS in evaluation of ovarian lesions and compare O-RADS with GI-RADS regarding malignancy rate, the validity and reliability through pathological results and other modalities

Ultrasound (US) continues to be the initial imaging modality of choice for the identification and characterization of adnexal masses (AM) . Structured reporting of AM findings was identified by a Society of Radiologists in Ultrasound consensus working group as a target for the investigation to improve the management of women with AM .

Many established guidelines and structured reporting have been developed using sonography to characterize AM, including subjective assessment, simple scoring systems, and statistically derived scoring systems .

In 2008, the International Ovarian Tumor Analysis (IOTA) group proposed the use of US simple rules for the diagnosis of ovarian malignancy. These are based on a set of five US features indicative for a benign tumor (B features), and five US features indicative for a malignant tumor (M features)

. In 2009, the Gynecology Imaging Reporting and Data System (GI-RADS) was designed as an attempt allowing standardized reporting of AM. This system is based on recognition patterns and criteria provided by the IOTA.

The American College of Radiology (ACR) published the Ovarian-Adnexal Reporting and Data System (O-RADS), which provides an up-to-date suggestion to stratify the AM according to sonographic features. The O-RADS offers a comprehensive algorithm that categorizes AM by their possibility of being normal (O-RADS 1), to high risk of malignancy (O-RADS 5) .

For the application of the US classification system of AM in clinical settings, it is essential to evaluate their validity and reproducibility. Several studies have investigated the validity of these risk stratification systems in the assessment of AM. However, data on the comparability and reproducibility of the systems are limited.

The purpose of this study is To detect added value of O-RADS in evaluation of ovarian lesions and compare O-RADS with GI-RADS regarding malignancy rate , the validity and reliability through pathological results.

Eligibility Criteria:
Inclusion Criteria:

* All newly diagnosed patients with ovarian lesions referred to the radiology department.
* Must be able to be examined.

Exclusion Criteria:

* Patients younger than 17 years old
* Patient who refused to be a part of the study and undergo examination.
PErsonalized and Adaptive Kinesthetic stImulation Therapy, Based on Cardio-respiratory Holter moNitoring, for Sleep Apnea syndrOmes

This study aims at quantifying the performance of kinesthetic stimulation to reduce the burden of obstructive sleep apneas and hypopneas.

Severe sleep apnea patients will undergo two polysomnographies (PSG), one with kinesthetic stimulation triggered on the detection of apneas and hypopneas (treated night ) and the other without kinesthetic stimulation (non-treated night ). Comparison of apnea and hypopnea indices (AHI) and of oxygen saturation between the treated and non-treated night will be taken as indicators to quantify the performance of this potential new therapy.

Eligibility Criteria:
Inclusion Criteria:

Patients who meet all the following criteria at the time of enrollment may be included:

* Man or woman aged more than 18 years old.
* Patient with severe obstructive apnea syndrome diagnosed on polysomnography or polygraphy performed less than 6 months ago with (AHI \> 30/h and 80% of obstructive events) and (ODI 4% \> 20 or time with SaO2 below 90% \> 5%).
* Patient free from continuous positive airway pressure (CPAP) treatment or any other SAS treatment for at least 3 months
* Patient with no psychrotropic medication or stable psychotropic medication since the diagnostic polysomnography or polygraphy examination
* Patient was informed and has signed the informed consent

Exclusion Criteria:

Patients who meet any one of these criteria will be excluded from the study:

* Patients sleeping less than 4 hours per night
* Patients suffering from respiratory failure, such as chronic obstructive pulmonary disease (COPD), pneumonia, pulmonary edema, pulmonary fibrosis, asthma, pulmonary arterial hypertension.
* Patients developing periodic breathing or Cheyne Stokes respiration
* Obese patient (BMI\>35kg/m2)
* Patient with autonomic dysfunction (symptoms include orthostatic hypotension, exercise intolerance, sweating abnormalities, digestion difficulties, urinary problems, vision problems) as complication of diabetes, Parkinson's disease or other primary pathologies.
* Patient suffering from restless leg syndrome or periodic leg movement (PLM) not related to obstructive sleep apnea, i.e. PLM index \> 15/h excluding movements linked to respiratory events.
* Patient suffering from positional sleep apnea syndrome (SAS), i.e. supine apnea hypopnea index (AHI) at least twice that of the non-supine AHI
* Patient suffering from severe peripheral neuropathy
* Vulnerable patient in accordance with article L1121-6 of Code de la Santé Publique (CSP)
* Patient already involved in another clinical study that could affect the result of this study
* Pregnant patient
Expectations of Patients Regarding Exercise in an Outpatient Clinic

Exercise and physical activity are recommended in many clinical guidelines in orthopdeci diseases. Costs, time, doctor-patient-communication and the type of prescription are possible limitations of prescribing exercise as a therapy. It is essential to know the expactiations and attitude of the patients for an accurate, patient-centered, prescription. This trial aims to reveal patients point of view and attitude.


Eligibility Criteria:
Inclusion Criteria:

* patient presented the first time in the outpatient study with an issue

Exclusion Criteria:

* language barrier
* cognitive impairment which could lead to missunderstadning of the survey
Intra Articular Ankle Fractures

The purpose of this study is to examine the effect of early, percutaneous, intra-articular saline lavage on the undiluted synovial fluid microenvironment during the acute phase following intra-articular fracture of the human ankle. We hypothesize that early intervention with percutaneous joint lavage in the first 0-48 hours after injury will attenuate the production of pro-inflammatory cytokines, MMP's and cartilage breakdown products compared to non-lavaged control subjects at the time of surgical fixation.

Saline joint lavage represents a potentially simple, low-risk and minimal-cost intervention which has not been previously studied for the purpose of reducing the post-fracture inflammatory burden in human subjects. Open joint lavage at the time of definitive surgical fixation is within the standard of care, but typically occurs greater than 10 days after injury by which time cartilage degradation has already begun. Early, saline lavage during initial presentation to the emergency department may theoretically alter the progression of the intra-articular inflammatory response by evacuating the bulk of the developing synovial-fluid fracture hematoma.

The vast majority of ankle fractures present to the ER or urgent care within a day of fracture. Moreover, a large subset of these fractures require reduction (fracture setting) that is painful. It is our standard of care to perform an intra-articular lidocaine injection before reduction. We will take advantage of this standard of care needle insertion to the fractured ankle to perform saline joint lavage to diminish this early inflammatory burden. Adult patients presenting to the Duke University Hospital Emergency Department with an intra-articular fracture of the ankle joint between 0-48 hours from the time of injury will be eligible for inclusion. Patients will be randomized into one of two groups: 1) intra-articular saline lavage, vs 2) no intra-articular saline lavage. Intra-articular aspiration of synovial fluid from the injured ankle will occur both at the time of presentation to the emergency department and at the time of surgery. These synovial fluid samples will be analyzed for differences in key pro-inflammatory cytokines, matrix metalloproteinases and cartilage breakdown products to determine if early saline lavage effects the composition of the synovial fluid micro-environment.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (over 18 years of age)
* Must be treated at Duke University Hospital Emergency Department
* Intra-articular fracture of the ankle joint (any fracture of the fibula or tibia in which the fracture line(s) exit into the cartilage surface of the ankle joint)
* Subjects presenting between 0-48 hours from the time of injury

Exclusion Criteria:

* Age \< 18 y.o.
* Open fracture
* Nonoperatively treated fractures
* Subjects presenting \>48 hours from the time of injury
Trial to Evaluate an Optimization Procedure of Alveolar Recruitment During Transport Performed by Nurse Anesthetists in Intensive Care

Intra hospital transport of ICU patients is still at high risk of respiratory complications.We propose to determine if endotracheal tube clamping prior to disconnect ventilator allows to avoid oxygenation decrease.

Changing respiratory support and multiples endotracheal tube disconnections may induce a loss of PEEP and finally lead to alveolar derecruitment. This study is an evaluation of a care procedure to limit the incidence of alveolar derecruitment in ventilated intubated ICU patients during transport for CT scan.

Intra hospital transport of ICU patients are performed by anesthesiologist nurses, the physician entrusts them this activity.

This is a randomized controlled study, the procedure is to clamp endotracheal tube before each disconnection from ventilator.

Eligibility Criteria:
Inclusion Criteria:

* intensive care patient
* intubated, sedated, controlled assisted ventilation
* Intra hospital transport for CT scan
* arterial catheter
* the patient or his trusted person consent to the study

Exclusion Criteria:

* Patient Covid tests positive or Covid test results not received
* extubated, unsedated,
* reinforced tube
* tracheotomy
* pregnancy
* guardianship