cyrilzakka/clinical-trials huggingface dataset:
Micro-Electrodes Implanted in a Human Nerve

The main objective of the intervention in the study is devise feasibility using high-count microelectrode arrays implanted into peripheral nerves of patients with limb amputations or peripheral nerve injury. These microelectrodes will be custom-made and are not available for commercial distribution. The investigators hypothesize that recording neural signals from a large number of microelectrodes will provide selective motor information in high enough numbers to allow control over future artificial devices with many moving parts, i.e. artificial limbs with shoulder, elbow, wrist, and/or individual fingers that move. These studies will also investigate to what extent microstimulation of nerve fibers can provide sensory feedback from a prosthetic limb.

The investigators will also conduct up to three acute surgeries where a Utah slanted Electrode Array (USEA) will be implanted in volunteers who are about to undergo limb amputations. These acute implantations will provide Dr. Hutchinson with human surgical experience in implanting USEAs and evaluating the containment system we will be using to immobilize the implanted USEA in the nerve.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age and less than 65 years of age
* amputations
* peripheral nerve injury
* twelve participants for the 30 day implantation/physiological experimentation study
* three participants for the acute surgical implantation part of the study

Exclusion Criteria:

* incarceration
* pregnancy
* inability to consent
* psychiatric comorbidity
* increase the risk of adverse effects of general anesthesia
LEO19123 Cream in the Treatment of Atopic Dermatitis

To compare the efficacy and safety of two different dose combinations of LEO19123 (calcipotriol and LEO80122) with LEO19123 cream vehicle for 3 weeks in the treatment of patients with atopic dermatitis


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of atopic dermatitis according to Hanifin and Rajka
* The score of erythema, induration/papulation, excoriation and lichenification, four of the five clinical signs in the Total Severity Score, should at least correspond to moderate involvement, i.e. severity greater than or equal to 2, at Visit 1
* Treatment area amenable to topical treatment
* Attending a hospital outpatient clinic or the private practice of a dermatologist
* Following verbal and written information about the trial, the patient must provide signed and dated informed consent before any study related activity is carried out, including activities relating to washout period
* Males between 18-50 years

Exclusion Criteria:

* Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine) or corticosteroids within 4 weeks prior to randomisation. (Inhaled or intranasal steroids for asthma or rhinitis may be used)
* PUVA or UVB therapy within 4 weeks prior to randomisation
* Topical treatment with immunomodulators (pimecrolimus, tacrolimus) or corticosteroids from WHO groups III or IV within 2 weeks prior to randomisation
* Other topical therapy on the treatment area (except for the use of emollient on the entire body and use of hydrocortisone cream 1% on AD lesions on head and neck) within 1 week prior to randomisation
* Use of any other kind of treatment (drug, non-drug) for AD during the study except for the use of: - Investigational product on trunk and limbs lesions only during the treatment phase - Hydrocortisone cream 1% on head and neck lesions - Emollient on the entire body
* Use of anti-histamines during the study
* Current diagnosis of exfoliative erythrodermia
* Clinical infection (impetiginised atopic dermatitis) on the treatment area
* Planned exposure to amount of sun or ultraviolet light during the study that may affect atopic dermatitis
* Known or suspected hypersensitivity to component(s) of the investigational product
* Known or suspected severe renal insufficiency or severe hepatic disorders
* Patients with history/signs/symptoms suggestive of an abnormality of calcium homeostasis associated with clinically significant hypercalcaemia
* Patients with history of cancer including skin cancer
* Patients with history of an immunocompromised disease (e.g. lymphoma, HIV, Wiskott-Aldrich Syndrome)
* Current participation in any other interventional clinical trial
* Patients who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks prior to randomisation
* Previously randomised in this study
* Patients known or suspected of not being able to comply with a trial protocol (e.g. alcoholism, drug dependency, or psychotic state)
Low Dose Ketamine VR Analgesia During Burn Care Procedure

The purpose of the research is to see whether a low dose of ketamine, a medication used to reduce pain, enhances the effectiveness of a virtual reality video game, which is used as a form of distraction from pain during a painful burn care procedure.

This study is conducted in a hospital setting. It is a randomized controlled trial comparing the use of virtual reality distraction (VRD) and standard pain medications to the use of VRD, standard pain medications and a single low dose of ketamine as a means to reduce pain during a painful procedure in patients in the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Compliant and able to complete questionnaires
* No history of psychiatric disorder
* Not demonstrating delirium, psychosis or any form of Organic Brain Disorder
* Able to communicate verbally
* English-speaking
* IV access already in place

Exclusion Criteria:

* Age less than 18 years
* Not capable of indicating pain intensity
* Not capable of filling out study measures
* Evidence of traumatic brain injury
* History of psychiatric disorder
* Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems
* Unable to communicate orally
* Receiving prophylaxis for alcohol or drug withdrawal
* Developmental disability
* Any face/head/neck injuries that interfere with the use of Virtual Reality equipment
* Non-English Speaking
* Extreme susceptibility to motion sickness
* Seizure history
* No IV access already in place
Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM)

This is a Humanitarian Device Exemption (HDE) approved device. The purpose of this study is to evaluate the continued safety and probable benefit of the restor3d Total Talus Replacement device in commercial use.


Eligibility Criteria:
Inclusion Criteria:

* ≥22 Years of Age
* Scheduled to receive TTR implant for one of the following indications:
* Avascular necrosis of the talus
* Avascular necrosis of the talus in addition to talar collapse, cysts or non-union
* Large, uncontained, unstable, or cystic talar osteochondral defects with risk of collapse or talar osteochondral defects not responsive to traditional treatments
* Nonunion following talar fracture or talar extrusion, unresponsive to more conservative treatments
* Have not had a prior Total Talus Replacement device implanted
* Not planning to receive bilateral Total Talus Replacement devices
* Subject signs a written informed consent form (ICF) prior to the surgical procedure

Exclusion Criteria:

* Surgical procedures other than those listed in the indications for use.
* Use of implant greater than 6 months from date of patient's preoperative CT scan.
* Degenerative changes in the tibiotalar, subtalar or talonavicular joints.
* Gross deformity in sagittal or coronal planes. More than 15 degrees of varus or valgus deformity in the coronal plane, or more than 50% subluxation anteriorly or posteriorly of the talus in the sagittal plane
* Patients with an active local or systemic infection.
* Osteonecrosis of the calcaneus, distal tibia or navicular.
* Known history of existing malignancy, or any systemic infection, local infection, or skin compromise at the surgical site.
* Blood supply limitations and previous infections that may prevent healing.
* Physical conditions that would eliminate adequate implant support or prevent healing, including inadequate soft tissue coverage.
* Conditions which may limit the patient's ability or willingness to restrict activities or follow directions postoperatively during the healing period.
* Presence of neurological deficit which would prevent patient postoperative compliance.
* Patients with foreign body sensitivity, suspected or documented material allergy or intolerance. Where material sensitivity is suspected, appropriate tests should be conducted, and sensitivity ruled out prior to implantation.
Low-dose S-Ketamine and Postpartum Depression in Parturients With Prenatal Depression

Prenatal depression is an important risk factor of postpartum depression. Low-dose ketamine has been used for depression treatment. As a stereoisomer of ketamine, s-ketamine has similar effects to ketamine in anti-depression. We speculate that, for pregnant women with prenatal depression, low-dose s-ketamine infusion after childbirth may reduce the incidence of postpartum depression.

Studies have shown that prenatal depression symptoms are important predictors of postpartum depression. Screening of pregnant women's mental condition before giving birth, early identification of pregnant women with symptoms of prenatal depression, and providing appropriate interventions may play an important role in reducing the incidence of postpartum depression. Ketamine is an NMDA-receptor antagonist. In recent years, many studies confirmed that ketamine has a significant antidepressant effect. As a stereoisomer of ketamine, s-ketamine has similar effects to ketamine in anti-depression. In clinical application, s-ketamine has stronger analgesic effect, better anesthetic effect and lower incidence of adverse psychological reactions. We speculate that, for pregnant women with prenatal depression, low-dose s-ketamine infusions after childbirth may reduce postpartum depression. Evidence is lacking in this regard.

Eligibility Criteria:
Inclusion Criteria:

* Parturients with age ≥18 years;
* Presence of prenatal depression (EPDS score ≥10);

Exclusion Criteria:

1. A clear history of mental illness (depression, schizophrenia, etc.) or communication difficulties;
2. Severe pregnancy complications, such as severe preeclampsia, placental implantation, HELLP (syndrome hemolytic anemia, elevated liver function and low platelet count) syndrom, placenta previa, and placental abruption;
3. American Society of Anesthesiologists classification ≥III;
4. Presence of contraindications to ketamine/s-ketamine use, such as refractory hypertension, severe cardiovascular disease (New York Heart Association classification ≥III), and hyperthyroidism.
Sacral Chordoma: Surgery Versus Definitive Radiation Therapy in Primary Localized Disease

Comparative study on surgery versus definitive radiation therapy in primary localized sacral chordoma

International, multicenter, comparative, open-label, parallel-group, mixed Observational-Randomized Controlled Trial.

All the patients, who are candidate for the study will receive full information on the characteristics, potential effectiveness and side effects of the two alternatives treatments: radiotherapy (RT) and surgical treatment Eligible patients will be asked to be randomized in order to receive treatment A (surgery, with or without RT) or treatment B (definitive RT) Who will refuse randomization will be included in the Prospective Cohort Study (PCS) and will be treated accordingly to their choice (treatment option A or treatment option B).

The same radiotherapy and surgical regimen will be administered in the PCS and in the Randomized Clinical Trial (RCT) cohort

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis (brachyury expression) of primary sacral chordoma,of any diameter and arising at any site from S1 to coccyx.
* Age≥18years
* ECOG-performance status (PS) 0-2
* No previous antineoplastic therapy
* Macroscopic tumor detectable at MRI/CT scan
* Patient amenable for surgery
* Patient amenable for RT
* Written informed consent given before the enrolment, according to International Conference on Harmonisation/good clinical practice (ICH/GCP).

Exclusion Criteria:

* Distant metastasis
* Inability to maintain treatment position
* Prior radiotherapy to the pelvic region
* Prior therapy for sacral chordoma (including surgery, cryoablation, hyperthermia, etc)
* Local conditions that increase the risk of RT toxicity (tumor ulcerated skin infiltration, non-healing soft tissue infection, fistula in treatment field)
* Rectal wall infiltration
* General conditions that increase the risk of RT toxicity (active sclerodermia, xeroderma pigmentosum, cutaneous porphyria)
* Presence of a second active cancer (with the exception of non-melanoma skin cancer in-situ cervix neoplasia and other in-situ neoplasia)
* Severe comorbidities resulting in a prognosis of less than 6 months
* Inability to give informed consent
* Other malignancy within the last 5 years
* Performance status ≥ 2 (ECOG).
* Significant cardiovascular disease (for example, dyspnea \> 2 NYHA)
* Significant systemic diseases grade \>3 on the NCI-CTCAE v4.03 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity
* Women who are pregnant or breast-feeding
* Psychological, familial, social or geographic circumstances that limit the patient's ability to comply with the protocol or informed consent
Preoperative Short Course Radiotherapy With Chemotherapy and Camerelizumab in Locally Advanced Rectal Cancer

This is a open-label, single-arm study to investigate the safety and efficacy of consolidative chemotherapy with camrelizumab, an anti-PD-1 antibody drug following short course radiotherapy and subsequent surgical therapy in patients with locally advanced resectable rectal cancer.

Patients with locally advanced rectal cancer (cT3-4 or N+) are assigned to receive preoperative 5 × 5 Gy irradiation over 5 days with consolidation chemotherapy consisting two cycles of CAPOX chemotherapy and camrelizumab, an anti-PD-1 antibody drug for two cycles. Subsequent surgical therapy is performed to evaluate the safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who personally provided written consent for participation in the study
2. Treatment-naive patients with rectal cancer, in whom the inferior margin of the tumor is at a distance of 10 cm or less from the AV before CRT
3. Primary rectal cancer histopathologically confirmed to be adenocarcinoma
4. Clinical stage of T3/T4 or N positive and M0,before CRT
5. Patients with the ECOG performance status of 0 or 1 at the time of enrollment
6. Women of childbearing potential who consent to practicing contraception during the period from giving informed consent to at least 23 weeks after the last dose of therapy
7. Male patients who consent to practicing contraception during the period from giving informed consent to at least 31 weeks after the last dose of the study drug

Exclusion Criteria:

1. Patients with recurrent rectal cancer or a history of pelvic radiation
2. Patients with a history of inflammatory bowel disease
3. Patients with a history of pneumonitis or interstitial lung disease
4. Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease
5. Patients requiring treatment with systemic corticosteroids or immunosuppressants or who have received these treatments within 14 days before enrollment in the study
6. Patients with a history of thyroid dysfunction
7. Patients with a history or finding of cardiovascular risk
8. Patients who are positive for any of the following: HIV1 antibody, HIV2 antibody, HTLV1 antibody
9. Patients who are pregnant or lactating or who may be pregnant
10. Patients with significant unstable mental diseases or other medical diseases that may interfere with the safety of the subjects, obtaining informed consent, or compliance with the procedures for the clinical study
Oxytocin Bolus Versus Infusion in Elective Cesarean Section"

Bolus administration of oxytocin is superior to infusion in time to achieving adequate uterine tone.

Oxytocin is the most commonly used uterotonic agent worldwide to achieve adequate uterine tone and prevent postpartum hemorrhage. Over the past decade, the trend has been towards lowering the dose to reduce oxytocin-related adverse effects including nausea, hypotension, chest pain, EKG changes, and maternal death. However, the optimal strategy for oxytocin administration remains controversial. Prior literature found bolus doses less than 5 IU to be effective in achieving adequate uterine tone with a significant reduction in adverse side effects. There is limited high quality data comparing bolus versus infusion administration of oxytocin. The current standard of care at the institution is an infusion of oxytocin 18 IU/hour (0.3 IU/min) and has been proven to be effective in achieving adequate uterine tone. However, the time to uterine tone appears to be slightly longer (3-4 mins) with the infusion method. Given that the estimated uterine blood flow is between 500-700 mls/min, the uterus can lose a significant amount of blood per second if uterine tone is not achieved quickly. Thus, the purpose of this research study is to compare bolus and infusion administration of oxytocin on parturients undergoing elective cesarean section. The primary objective of this study is to test the hypothesis that administration by bolus (vs. standard of care infusion) results in more rapid achievement of adequate uterine tone. Secondary objectives include determining estimated blood loss, prevalence of hypotension, nausea, vomiting, and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Parturients between the ages of 18 to 45 with singleton pregnancies
* Undergoing elective cesarean section under spinal anesthesia
* American Society of Anesthesia (ASA) physical status class I or II
* Patients must be able to provide written informed consent

Exclusion Criteria:

* Parturients in labor or ruptured membranes
* Multiple gestation
* Risk factors predisposing to uterine atony (history of placenta previa, preeclampsia, diabetes mellitus macrosomia, hydramnios, bleeding diathesis, uterine fibroids)
* History of uterine atony or postpartum hemorrhage
* History of inherited or acquired coagulation disorders, thrombocytopenia (platelet count \<100), or anemia (hemoglobin \< 8)
* History of allergy to oxytocin
* Patients not alert and orientated to person, place, and date. Patient must have, in the investigator's opinion, the physical and mental capacity to answer survey questions
Otological Study of Facial Cleft Patients Over 10 Years of Age (Excluding Isolated Cleft Lip) (EFEOF)

Studies published on the placement of transtympanic ventilatory tubes in children with cleft palate show heterogeneous results, highlighting the need for a new study with strong statistical power and long-term follow-up to clarify the real benefits of this intervention.

Mirashrafi (2022) and Maina (2022), for example, emphasize the current uncertainties regarding the management of otitis media with effusion in children with cleft palate. Mirashrafi conducted a study on 40 children and found no significant difference between those with a complete cleft palate and those with an incomplete cleft palate in terms of middle ear status after the placement of transtympanic ventilatory tubes. Maina, in an ongoing review, identified a lack of consensus on the optimal management of chronic otitis media with effusion, with outcomes being varied and often of low methodological quality.

The absence of convincing evidence justifies the need for further research to establish clear guidelines. The objective is to study the otological status of patients based on the presence or absence of ENT surgical management involving the placement of transtympanic ventilatory tubes.

The primary evaluation criterion will be ENT consultations:

Tympanic examination: Anatomical analysis of the tympanic membrane, assessing the presence or absence of:

Serous otitis Tympanic membrane perforation Retraction pocket Cholesteatoma Otorrhea Myringosclerosis Tympanosclerosis Audiometric tests: Assessment of auditory results from bone and air conduction curves for frequencies ranging from 250 to 4000 Hz, with analysis at every 250 Hz.

Eligibility Criteria:
Inclusion Criteria:

Presence of a facial cleft between 2004 and 2014 Minor and adult patients Followed up by ENT services at the University Hospital of Brest or Marseille

Exclusion Criteria:

Patients under legal protection (guardianship, curatorship, etc.) Refusal to participate Objection from one of the parents Isolated cleft lip No ENT follow-up
Determination of Biomarkers of the Effectiveness of Deep Brain Stimulation by Direct Electrophysiological Recordings of Brain Activity in a Cognitive Context - LFP-DBS 2024

Deep brain stimulation (DBS) is a therapeutic approach aimed at applying high-frequency, low-intensity electrical stimulation using electrodes implanted in subcortical structures and connected subcutaneously to a stimulator implanted in the abdomen. In recent years, new indications have been studied for severe and drug-resistant forms of several neurological and neuropsychiatric pathologies. Its non-lesional, reversible and customizable nature make it a therapy of choice.

However, several factors are currently slowing down the evolution and optimization of SCP.

The identification of objective, quantifiable and predictive criteria for the therapeutic effects of stimulation would allow an acceleration of the individualized identification of the therapeutic parameters of SCP. The surgical procedure for implanting the stimulation equipment is carried out in several stages, which offer unique opportunities to acquire individual imaging or electrophysiology data that are potentially predictive of the therapeutic effect of DBS. In order to continue the optimization of DBS procedures, and therefore to maximize its therapeutic effects, it seems crucial to us to take advantage of all the neurophysiological data likely to be collected during this procedure. Furthermore, given the multiplication of indications for SCP, it seems necessary to highlight specific markers. Thus, the use of neurocognitive and/or motor tests specific to each pathology and coupled with electrophysiological recordings and anatomical and functional examinations would make it possible to highlight specific functional biomarkers predictive of therapeutic effects.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Patient suffering from a pathology requiring treatment with deep brain stimulation: neurological disease (e.g.: Parkinson Disease, Essential Tremors, dystonia, epilepsy, etc.) or psychiatric disease (e.g.: Obsessive Compulsive Disorder, depression, eating disorders, etc.).
* Patient capable of understanding the study procedures and completing the self-questionnaires in French
* Patient informed and having signed the informed consent form

Exclusion Criteria:

* Contraindications to DBS, neurosurgery or anesthesia
* Patients with significant hemorrhagic or infectious risks
* Patient unable to perform the neurocognitive or sensorimotor tests
* Patient who is not a beneficiary of a social security system.