cyrilzakka/clinical-trials huggingface dataset:
Definition of Links Between Non-invasives Methods and Intracerebral EEG With Simultaneous Recordings.

Presurgical evaluation of epileptic patients require a precise mapping of cerebral regions implied in epileptic discharges and in normal function.

The current practice in most cases is to implant intracerebral electrodes in order to localize these regions in a reliable manner. However, non-invasive methods have been developed in order to record brain activity with no risk for the patient.

Still, it is necessary to validate and improve the signal processing methods and the underlying models these methods in order to optimize their use in clinical practice. To do so, it is necessary to record simultaneously electroencephalogram (EEG) and magnetoencephalogram (MEG) and stereo encephalogram SEEG (intracerebral). Such simultaneous recordings will permit to confront the exact same activity recorded non-invasively at the surface of the head, and represented on the brain thanks to the model and directly within the brain.

The objective is to define the conditions under which one can represent faithfully the activity measured intracerebrally from the surface measurements.

It will be record simultaneously MEG, scalp EEG and intracerebral EEG on a series of 60 patients. It will be record resting state signals, as well as stimulation protocols. The interictal epileptic discharges will be marked on the different modalities, and evoked potentials/fields computed in response to protocols. Sensitivity of recordings to activity visible on depth recordings will be evaluated as a function of localization of brain generators. Advanced signal processing methods will be used such as source localization and independent component analysis, in order to increase sensitivity of measures.


Eligibility Criteria:
Inclusion Criteria:

- Patients for whom implanting intracerebral electrodes is underway

Exclusion Criteria:

* Patients minors
* Pregnant or lactating women
Relationship Between Pelvic Floor Dysfunctions and Sexual Dysfunction in Female Patients with Systemic Sclerosis

Relationship Between Pelvic Floor Dysfunctions and Sexual Dysfunction in Female Patients with Systemic Sclerosis

Female patients with systemic sclerosis have a high incidence of pelvic floor dysfunction and sexual dysfunction.The association of sexual dysfunction in systemic sclerosis with many disease-related factors has been confirmed. There are numerous studies in the literature investigating the prevalence and risk factors of sexual dysfunction in women with SSc, the number of studies examining the prevalence and effects of pelvic floor dysfunction in SSc is limited. Moreover, no studies were identified in the literature that specifically investigate the relationship between pelvic floor dysfunction and sexual dysfunction.The aim of this study is to evaluate pelvic floor dysfunction and sexual dysfunction in women with SSc, examine the relationship between these dysfunctions, and compare the findings with data from a healthy control group.

Eligibility Criteria:
Inclusion Criteria:

* female gender
* being between 18-64 years old
* having a diagnosis of systemic sclerosis (SSc)
* being sexually active, and not having entered menopause

The control group will consist of healthy women aged 18-64 years who are sexually active, have not entered menopause, have no history of urological or gynecological surgeries other than cesarean section, and have no rheumatologic or severe chronic diseases.

Exclusion Criteria:

* the presence of current or past rheumatologic diseases other than SSc
* the presence of current urogynecological diseases
* a history of urological or gynecological surgeries other than cesarean section.
Supporting Caregivers of Persons With Dementia: A Pilot Study

The purpose of this study is to pilot the home Environmental Skill-Building Program (ESP) and an educational control intervention with persons with dementia and their caregivers (n=40) in preparation for a larger double-blind randomized controlled trial. Caregivers of persons with dementia often deal with difficult behaviors. The ESP is an occupational therapy intervention that helps caregivers adapt to their environment and build care-giving skills. The areas addressed include changes to the home set-up, adaptive equipment, instruction in strategies of problem-solving, energy conservation, safe task performance, and fall recovery techniques. A trial is needed with methodological rigor and to determine if the intervention is feasible in the Canadian health care system. Results will contribute to understanding how caregivers and people with dementia can be supported in their home environments.


Eligibility Criteria:
Inclusion Criteria:

* The caregiver must be the primary caregiver
* Caregiver reports that the care recipient has at least one limitation in basic activities of daily living (ADL) or two dependencies in instrumental activities of daily living (IADLs)
* The caregiver must:

  * provide at least 2 hours of care per day
  * be caregiving for at least 6 months and
  * be at least 21 years of age
* The care recipients need to have a diagnosis of dementia

Exclusion Criteria:

* Caregiver:

  * does not live with the care recipient
  * has poor health (undergoing treatments for cancer, hospitalized more than three times in past year)
  * planning to place care recipient in long term care within the next year
* Care recipients who are confined to bed most of the day or are minimally-responsive to touch or the environment are excluded
Evaluation of the Benefits of Ultrasound in Improving the Diagnosis and Management of Injuries the Child's Ankle

Evaluate ankle's ultrasound contribution in the accuracy of ankle's diagnosis of traumatic injuries (objectivated by reference's examination : ankle's MRI)


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 5 years and \< 18 years
* Isolated's trauma from one or both ankles
* First-line consultation for pediatrics emergencies at the University Hospital of Lille
* Informed and written consent of the holders of parental authority

Exclusion Criteria:

* Age \< 5 years and ≥ 18 years
* History of trauma of the same ankle dating from less than 3 month
* History of surgery of this same ankle
* Constitutional or acquired bone disease
* Associated trauma affecting another anatomical region than the ankle or midfoot
* Polytrauma (presence of several traumas including at least one endangers vital functions)
* Associated wound requiring surgical exploration
* initial management of this trauma in another center
* Non affiliation to a social security scheme
Study of Skin Balancing Gel Cream Safety and Influence of Skin Microbiome on Acne Prone Skin

The purpose of this study is to assess the safety of the skin balancing gel cream and examine the effects it has on the skin microbiome of individuals with non-cystic acne prone skin.

Acne, a chronic inflammatory condition, is estimated to affect greater than 85% of the population at some point. It is considered a common skin condition characterized by pimples and occurs when follicles are clogged leading to the formation of acne lesions. In this study, we want to evaluate the impact the skin balancing gel cream has on the skin microbiome on individuals who have mild to moderate non-cystic acne. We will be assessing the changes it has on specific microbiota (Cutibacterium acnes for example) and whether it is tolerated well on acne prone skin.

Eligibility Criteria:
Inclusion Criteria:

* Males and females between the ages of 18 years of age until 35 years of age
* Males must be willing to shave facial hair
* The presence of mild to moderate non-cystic acne based on investigator global assessment

Exclusion Criteria:

* Individuals who are pregnant or breastfeeding.
* Prisoners.
* Adults unable to consent.
* The presence of severe acne or cysts as noted by the investigator.
* Those who are unwilling to discontinue topical antibiotics, topical salicylic acid containing products and topical benzoyl peroxide containing products for two weeks to meet the washout criteria prior to enrolling.
* Those who are unwilling to discontinue all facial topical products except the cleanser and the product provided in the study.
* Individuals who have been on an oral antibiotic for acne within the previous 1 month.
* Individuals who have changed any of their hormonal based contraception within 3. months prior to joining the study.
* Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.
Auricular Acupuncture Stimulation for Chronic Pain

This proposal aims to investigate the treatment effect and underlying mechanism of transcutaneous acupuncture stimulation on chronic low back pain. We believe that this study, if successful, will provide new treatment options for chronic low back pain, reduce the use of opioid analgesics in chronic pain management, and enhance our understanding of the underlying mechanism of nerve stimulation treatment, as well as the pathophysiology and development of chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers 18-65 years of age.
* Meet the Classification Criteria of chronic LBP (having low back pain for more than 6 months), as determined by a referring physician.
* Received stable treatment or no treatment in the past month.
* At least a 10th grade English-reading level. English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.

Exclusion Criteria:

* Specific causes of back pain (e.g., epidural abscess, compression fracture, spondyloarthropathy, malignancy, cauda equina syndrome) or radicular pain, radiculopathy, or spinal canal stenosis. Complicated back problems (e.g., prior back surgery, medico-legal issues).
* Presence of headache/migraine, as well as widespread body pain such as fibromyalgia.
* The intent to undergo surgery during participation in the study.
* History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcomes (e.g., asthma or claustrophobia).
* Presence of any contraindications to MRI scanning (e.g., cardiac pacemaker, metal implants, fear of enclosed spaces, pregnancy, cannot lie still in fMRI scanner).
* Conditions that might confound longitudinal effects or interpretation of results (e.g. severe fibromyalgia, rheumatoid arthritis).
* Pregnant or lactating.
* Conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator during Session 1).
* Active substance abuse disorders within the last 24 months (based on subject self-report).
* Use of prescription steroids for pain during the past six months.
* Presence of any other acute or chronic pain disorder.
* Any medical conditions, such as peripheral neuropathy, that could affect the results of QST.
Open Versus Laparoscopic Left-sided Hepatectomy Trial

Open versus Laparoscopic Left-sided Hepatectomy (OLLEH) trial Multi-institutional, prospective and randomized trial in patients undergoing left sided hepatectomy through laparoscopic versus open procedure.

Primary endpoint: Functional recovery Secondary endpoint: Hospital duration, estimated blood loss, operation time, resection margin status, postoperative complication, mortality, liver function laboratory test, re-admission, quality of life, cosmesis, cost effectiveness

Laparoscopic left-sided hepatectomy is widely performed for the treatment of various hepatic neoplasms. Many studies have reported that laparoscopic left-sided hepatectomy is safe and effective compared with open conventional left-sided hemihepatectomy. However, prospective study is rare and there is no randomized controlled trial.

The surgeons who are affiliated at a medical center in capital area of Korea launched the Open versus Laparoscopic Left-sided Hepatectomy (OLLEH) trial to verify the surgical outcome of laparoscopic left-sided hepatectomy.

Laparoscopic surgery has benefits that less wound and less pain. The hypothesis of the study is 'The laparoscopic left-sided hemihepatectomy is better than open surgery from functional recovery.

Eligibility Criteria:
Inclusion Criteria:

1. Patient who underwent open or laparoscopic left-sided hepatectomy for benign or malignant neoplasm of the liver
2. Child-Pugh A without portal hypertension

   * No portosystemic shunt
   * No splenomegaly
   * Platelet count \>100,000/ul
3. Age 18 to 80
4. Eastern Cooperative Oncology Group performance status: 0 or 1
5. American society of anesthesiology class: I or II
6. Informed consent

Exclusion Criteria:

1. Additional intervention to the liver (Radio Frequent Ablation, Percutaneous Ethanol. Injection Therapy or others)
2. Combined hepatectomy
3. Bile duct reconstruction
4. Intrahepatic duct stone
5. Upper abdominal laparotomy history
6. Previous hepatectomy
7. Combined operation for extrahepatic disease
8. Vulnerable population (mental retardation, pregnancy)
9. Patient who participated in other clinical trial within 6 months
A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syndrome

The purpose of this study is to evaluate the efficacy of abatacept compared to placebo in patients with Sjögren's Syndrome.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score of at least 5
* Positive anti-SS-A/Ro antibody at screening
* meet the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism Classification Criteria for Sjögren's Syndrome (EULAR SS)

Exclusion Criteria:

* Secondary Sjögrens syndrome
* Active life-threatening or organ-threatening complications of Sjögren's-syndrome
* Other medical condition associated with sicca syndrome

Other protocol defined inclusion/exclusion criteria could apply
The Sunrise OSA Trial

A prospective, randomised, blinded pilot study comparing the Sunrise solution and overnight polygraphy for the diagnosis of OSA in adult patients. Patients under investigation for OSA will use both devices simultaneously for a single overnight sleep study. They will be randomised to receive their treatment decision based on either the Sunrise solution or polygraphy. A retrospective check of their diagnosis will be done.


Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥18
2. Ability and willingness to provide informed consent
3. Patient referred for suspected OSA
4. BMI \>28 kg/m2
5. Epworth Sleepiness Score \>12
6. Reported snoring (criterion may be ignored if patient sleeps alone)
7. Patient able to use a smartphone application and having an internet connection at home

Exclusion Criteria:

1. Patient already treated for OSA
2. Patient has PSV or HGV driving license
3. Unstable cardiac disease
4. Supplemental oxygen
5. Known secondary sleep pathology e.g. Periodic Limb Movement Syndrome, Narcolepsy, Circadian Disorder, Obesity Hypoventilation Syndrome
6. Concerns about sleepy driving or any other potentially dangerous symptom from physician or urgent referral from GP when patient has been told to stop driving
7. Pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure
8. Patient whose beard is too thick to wear the Sunrise device, and who does not wish to shave
9. Patient with acrylic or painted fingernails, who does not wish to remove acrylic or paint
Improving Activity in Individuals with Cerebral Palsy

Individuals with cerebral palsy are known to have a reduced amount of physical activity; yet, there are no known intervention strategies for improving the number of steps they take each day. This study will use wearable physical activity monitors to assess if behavioral coaching is a viable strategy for combating the reduced physical activity seen in this patient population.

A lack of physical activity in persons with cerebral palsy is known to have cascading effects on their overall health. Despite this recognition, there have been limited attempts to improve the physical activity of this patient population. The overall landscape of this project is that a cohort of persons with cerebral palsy will undergo 8 weeks of physical activity that is guided by behavioral coaching. This study aims to determine the impact of behavioral coaching on 1) the amount of daily physical activity, 2) changes in the sensorimotor cortical activity, 3) changes in laboratory assessments of functional mobility. The participants with CP will initially undergo neuroimaging and a battery of clinical assessments. After completing the baseline tests, the participants will undergo 8-weeks of behavioral coaching where they are encouraged to increase the number of steps they take per-day. After completing the 8 weeks, the participants will repeat the same assessments that were performed at baseline.

Eligibility Criteria:
Inclusion Criteria:

* Cerebral palsy diagnosis and ambulatory (Gross Motor Function Classification Score \[GMFCS\] levels between I-III).

Exclusion Criteria:

* No orthopedic surgery in the last 6 months, botulinum injections within the last 6 months, or metal in their body that would preclude the use of MEG.
Feasibility of Remote ECTG Monitoring Home@Hospital in Complicated Pregnancies

The objective of this single center, interventional cohort study is to evaluate the feasibility of remote electrophysiological cardiotocography (eCTG) monitoring in complicated pregnancies in a home@hospital setting.

The primary objective is to assess:

• The success rate of the self-administered eCTG measurement

The secondary objective is to asses:

* Maternal and perinatal outcomes
* Patients wellbeing and satisfaction.
* Healthcare professionals' (HCPs') satisfaction
* Analysis of antenatal costs

Participants will:

* Self-administer remote eCTG monitoring once daily during admission (or at least twice weekly at the outpatient clinic)
* Self-measure their blood pressure, heartrate and temperature
* Enter the measurements, symptoms and worries into an application on their telephone.
* Answer questionnaires at 3 moments during the study, assessing their wellbeing and satisfaction of the received care and self-administered remote monitoring device.


Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

* Minimum age of 18 years old
* Pregnant patients with a gestational age between 32+0 and 36+6 weeks and days
* Singleton pregnancy
* Any indication for fetal monitoring at least twice per week (e.g.):

  * Pre-eclampsia (PE)
  * Fetal growth restriction (FGR)
  * Preterm pre-labor rupture of membranes (PPROM)
* Absence of exclusion criteria \> 24 hours after admission.
* Oral and written informed consent is obtained.

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* An indication for intravenous medication
* Blood pressure \>160/110 A millimeter of mercury (mmHg)
* Absent-/or reversed flow umbilical artery Doppler
* Hemolysis Elevated Liver enzymes and Low Platelets (HELLP) (Table 1)
* Obstetric intervention expected \<48 hours, e.g. due to:

  * Non reassuring cardiotocography (CTG)
  * Active vaginal blood loss
  * Signs of abruption placentae
  * Meconium stained amniotic fluid
  * Signs of chorioamnionitis
* Patients admitted with a clinical diagnosis of sepsis with hypotension (i.e. septic shock).
* Insufficient knowledge of Dutch or English language
* Insufficient comprehension of instruction Nemo Remote® or patient information
* Fetal and/or maternal cardiac arrhythmias
* Contraindications to abdominal patch placement (dermatologic diseases of the abdomen precluding preparation of the abdomen with abrasive paper)
* Patients connected to an external or implanted electrical stimulator, such as Transcutaneous Electro Neuro Stimulation (TENS) and pacemaker (because of disturbance of the electrophysiological signal).
A Bioequivalence Study Of 4 Mg Fesoterodine Extended-Release Tablets (Toviaz™) In Healthy Subjects

To demonstrate bioequivalence of fesoterodine 4 mg tablets manufactured at Vega Baja, versus Zwickau.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Subjects with evidence or history of clinically significant urologic diseases
* A positive urine drug screen
* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method
Cefazolin Subcutaneous Microdialysis in Morbidly Obese Patients

The investigators hypothesize that cefazolin perfusion to subcutaneous adipose tissue is reduced in morbidly obese patients. The primary objective of this exploratory pilot study is therefore to investigate target site (subcutaneous adipose tissue) penetration of cefazolin in morbidly obese patients and non-obese patients. The investigators aim to examine whether and how cefazolin plasma concentrations are predictive of subcutaneous (target) cefazolin concentrations. Possible factors of influence on the distribution of cefazolin (tissue perfusion, body weight, distribution of adipose tissue, other) will be identified.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index \> 40 kg/m2
* BMI between 20-25
* undergoing laparoscopic gastric banding, or bypass surgery or sleeve gastrectomy (See population description for surgery type of the non-obese group)
* 21-60 years old
* American Society of Anaesthesiologists (ASA) physical status II to III

Exclusion Criteria:

* pregnancy
* breastfeeding
* known allergy for cefazolin/nadroparin
* known ejection fraction of \< 35%
* renal insufficiency
Circulating Tumor DNA in Patients Summoned for Colonoscopy; - a Liquid Biopsy for Detection, Characterization, Individualized Treatment and Follow-up of Colorectal Cancer

CoLiQ is a clinical study designed to evaluate the clinical usefulness of circulating tumor DNA (ctDNA) markers found in blood, as a liquid biopsy for diagnosis, prognosis and follow-up of colorectal cancer. The main questions it aims to answer are: 1) Can a panel of ctDNA markers identify CRC patients among the other patients summoned for colonoscopy? and 2) Does the type, number and level of ctDNA markers vary with the subtype and clinical course of CRC? Participants will be asked to answer a questionnaire and give a blood sample at inclusion. In addition, patients with CRC will be asked to give an extra test tube at their routine treatment and follow-up blood sampling.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years old summoned for colonoscopy
* Patient able to understand and sign written informed consent

Exclusion Criteria:

* Patient \< 18 years old
* Patient unable to understand or give written informed consent
* Patient unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the investigator as unlikely to complete the study