cyrilzakka/clinical-trials huggingface dataset:
BCI (Brain Computer Interface) Intervention in Autism

This study aims to demonstrate that improvements in identification of social clues (and improvement of overall social behaviour) in subjects with ASD can be achieved using social games together with a BCI setup.

The primary goal is to ensure increased rate of responses to joint attention cues.

Intervention Type is a Device (brain computer interface using EEG). Structure: (1) initial eligibility screening (within 1 week after admission), (2) pre-intervention (first week of study, baseline outcome measures and additional evaluations), (3) intervention process (16 weeks), (4) post-intervention (outcome measures and additional evaluations), and (5) follow-up (outcome measures at 6 months).

Clinical research has demonstrated that ASD children have deficits in the interpretation of others intentions from gaze-direction or other social attention cues (Baron-Cohen, Baldwin, \& Crowson, 1997).

The purpose of the study is to investigate whether a brain computer interface (BCI) using electroencephalographic (EEG) signals can be used to train social cognition skills (in particular interpretation of gaze direction pointing to objects of interest) in ASD patients and whether this improves clinical symptoms.

The intervention comprehends seven BCI sessions spread over four months. The first four sessions are planned to occur weekly, and the rest monthly. In each session, the subject is asked to identify objects of interest based on the gaze direction of an avatar. The subject response is interpreted from the EEG signal (using the P300 component, as established in our previous work).

Eligibility Criteria:
Inclusion Criteria:

* Positive diagnostic results for ASD in:

Autism Diagnostic Interview-Revised; Autism Diagnostic Observation Schedule; The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.

Exclusion Criteria:

* Global Intelligence Quotient \< 80
* Associated medical condition such as epilepsy, neurocutaneous or other genetic syndromes, or other usual comorbidity in ASD samples
Semi-rigid Ureteroscopy Versus Flexible Ureteroscopy For the Treatment of Proximal Ureteric Stone

The present study is randomized in nature, comparing the stone free rate and complications rate between semi-rigid ureteroscopy (SR-URS) and Flexible Ureteroscopy (F-URS) for the treatment of Proximal Ureteric stone (PUS), whereby the preoperative assessments, procedure and reporting of outcomes will all be standardized.

There are various treatment options that can be used for the treatment of PUS, which include extracorporeal shockwave lithotripsy (SWL), ureteroscopy (URS), percutaneous nephrolithotomy (PCNL), antegrade uretero-lithotripsy, laparoscopy, and rarely, open surgical procedures. However, the standard, and the most frequently used modalities are SWL and ureteroscopy. When comparing the effectiveness in the treatment of Proximal Ureteric stone (PUS) between SWL and URS, SWL has lower rates of complication and morbidity, but URS has a higher likelihood of successfully treating the patient within a single procedure. Additionally, with the advancements in technology and miniaturization of the ureteroscopes, along with the presence of auxiliary instruments such as holmium laser and retrieval baskets, ureteroscopy is more widely used.

In the proximal ureter, SR-URS tends to encounter difficulties in accessing the stone, but F-URS aids in overcoming those difficulties. As a result, the use of F-URS for PUS has indicated a strong success rate with lower likelihood of complications. When comparing the drawbacks of the two types of modalities, F-URS tends to be more expensive, and requires auxiliary instruments. And SR-URS tends to have lower success rate along with an increased rate in complications.

The precedence of FURS over SR-URS in the treatment of PUS is yet to be extensively studied. Presently there are only five studies that have compared the two modalities of treatment. But, due to the lack standardization of variables, procedure, follow-up imaging and reporting of outcomes in the past studies, it is imperative to conduct study that is prospective and randomized in nature.

The present study is randomized in nature, comparing the stone free rate and complications rate between SR-URS and F-URS for the treatment of PUS, whereby the preoperative assessments, procedure and reporting of outcomes will all be standardized.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Single proximal ureteric stone indicated for active treatment with ureteroscopy (stented or non-stented)

Exclusion Criteria:

* Solitary Kidney
* Bilateral ureteric stones
* Ipsilateral multiple simultaneous ureteric stones
* Ipsilateral kidney stone
* Active UTI
* Coagulopathy diseases
* Ipsilateral ureteral anomalies, ureteral disorder (tumor or stricture) or previous ureteral open surgery.
* Pregnant patients.
* Unable to give informed consent.
* Patient is not agreeing to go through the randomization.
Comparison of Two Modes of Transcutaneous Electrical Nerve Stimulation (TENS) in Chronic Neuropathic Radiculalgia

This study will compare 2 types of Transcutaneous Electrical Nerve Stimulation (TENS) to treat chronic neuropathic pain. TENS involves the application of electrical stimulation to the skin via surface electrodes to stimulate nerve fibres for pain relief.

TENS is already recommended in clinical practice to treat chronic neuropathic pain. The objective of this study is to compare the efficacy of 2 different modes of TENS: conventional TENS (c-TENS) and mixed-frequency TENS (m-TENS). Randomization will determine the mode that the patient has to test during the first month.

Each patient will test successively each mode during 1 month at home (3 sessions 1 hour/day). Then, the patient will test the other mode during the second month. Up to 6 months, the patient will be free to use the mode of TENS he wants.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years old or older
* Patients with chronic neuropathic radiculalgia from at least 3 months of evolution
* Radiculalgia VAS \> or egal to 40/100
* Neuropathic pain diagnostic (DN4) score \> or egal to 4
* Patient who has accepted to participate in the study by signing the informed consent form

Exclusion Criteria:

* Pregnancy
* Dermatosis in the painful dermatome
* Venous or arterial thrombosis of the lower limbs
* Patient with active implantable medical device
* Severe cognitive disorders
* Patient under a legal protection regime(guardianship/curatorship/guardianship of justice)
* Previous use of TENS to treat radiculalgia
An Analysis of Treatment Timelines for Lung Cancer Patients Across System Evolutions

This study is a single center, minimal risk, physician initiated retrospective chart review. An analysis of treatment timelines for patients diagnosed with lung cancer within the St. Elizabeth system from January 2013 until study completion. The study investigator and designee(s) will review patient electronic medical records, extracting data related to the symptom presentation, diagnosis, and treatment of new diagnoses of lung cancer. Collected data will focus on dates of encounters, diagnostic imaging/procedures, and treatments, with data analysis evaluating time between care encounters and potential delays in care. The data will be further stratified based on system-wide changes implemented to improve efficiency, patient outcomes, and patient experience.


Eligibility Criteria:
Inclusion Criteria:

* Patient seen within the St. Elizabeth system
* \>=18 years of age
* New diagnosis of histologically or cytologically documented primary lung cancer diagnosed January 2013 or later

Exclusion Criteria:

* Patients with metastatic lung disease of other primary
* Other malignancies at investigator's discretion
* Patient received treatment at a facility outside of St. Elizabeth where records are not available through EPIC
* Patient currently undergoing treatment for new diagnosis of lung cancer
A2 GUM Post-Market Effectiveness Study

This is a post-market, real-life effectiveness study of A2 growing up milk on toddlers' gut comfort.

This post-market study primarily aims to assess the real-life effectiveness of a newly-launched A2 milk on toddlers' gut comfort via evaluating individual GI symptoms and GI-related behaviors compared with other milk products and milk alternatives.

Eligibility Criteria:
Inclusion Criteria:

* Having obtained his / her parents' (or his or her legally accepted guardian written informed consent and having evidence of personally signed and dated informed consent document indicating that the child's parent(s) / legal guardian has been informed of all pertinent aspects of the study.
* Children 12 - 36 months of age at enrolment.
* Children who have been born full-term (≥ 37 completed weeks of gestation) and having a birth weight ≥ 2.5 kg and ≤ 4.5 kg.
* Children who are habitually consuming some cow's milk, other traditional milks (including non-A2 GUMs, kids' milk, white milk, flavored milk) and/or dairy or non-dairy alternative milks (such as those sourced from goats, sheep, soy, rice, coconut, and nut).
* Child's parent(s) / guardian is of legal age of consent, has sufficient command of Chinese (Mandarin) language to complete the informed consent and other study documents, is willing and able to fulfill the requirements of the study protocol.

Exclusion Criteria:

* Chronic infectious, metabolic, genetic illness or other disease including any condition that impacts feeding or may impact outcome measures.
* Known and diagnosed cow's milk protein allergy.
* Children currently using or having ever used specialty infant formula and/or GUMs such as hypoallergenic (HA), lactose-free, or anti-regurgitation formulas.
* Children who have known cognitive and developmental disorders.
Strengthening of the Peroneus Longus Muscle in Patients With Dorsiflexed First Ray

BACKGROUND: The first metatarsal and medial cuneiform form an important functional unit in the foot called "first ray". The first ray normal function requires that it load part of the body weight in the last period of the stance phase of gait. A dorsiflexed first ray may exist due to abnormal function of the peroneus longus muscle.

OBJECTIVE: To evaluate the improvement in first ray function in tha push-off phase of gait after a 4-week strengthening programme for the peroneus longus.

SUBJECTS: Patients with flexible dorsiflexed first ray. INTERVENTIONS: Patients will be randomly assigned to either group A, which will receive instructions for a strengthening programme of the peroneus longus muscle, or group B, which will receive no treatment.

MAIN MEASURES: The primary outcomes will be mean and maximum plantar pressure under the first metatarsal head.


Eligibility Criteria:
Inclusion Criteria:

* Flexible dorsiflexed first ray.

Exclusion Criteria:

* Traumatisms on the feet in the last 12 months.
* Previous foot surgery.
* Hallux abducto-valgus.
* Being in treatment with foot orthoses.
* Systemic musculoskeletal disease.
St. John's Wort Vs. Placebo in Obsessive-Compulsive Disorder.

The purpose of this study is to determine the effectiveness of St. John's Wort as compared to placebo (an inactive substance) in the treatment of outpatients with obsessive compulsive disorder.

The objective of the proposed study is to assess the efficacy of the herbal St. John's Wort (SJW) in the treatment of symptoms of obsessive-compulsive disorder (OCD). The approach is to conduct a 12-week, randomized, double blind, placebo controlled, parallel group pilot trial with 30 subjects in each of two arms. The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) will be the primary measure for evaluating OCD. An intention-to-treat analysis will be done to compare the two arms.

Eligibility Criteria:
Inclusion criteria

* Female patients: at least 2 years post-menopausal, surgically sterile, or practicing a medically acceptable method of contraception.
* Meets DSM-IV criteria for obsessive compulsive disorder

Exclusion criteria

* Primary diagnosis of major depression, dysthymia, panic disorder, social phobia, schizophrenia, schizo-affective disorder, bipolar disorder, or PTSD
* Substance abuse or dependence in the past 6 months
* Vascular dementia or primary degenerative dementia of the Alzheimer's type
* Treatment with MAOIs, TCAs, SSRIs, venlafaxine, nefazodone, remeron, citalopram, or bupropion within 14 days of first visit.
* Fluoxetine within 5 weeks of first visit.
* Failure to respond to at least two adequate antidepressant trials for obsessive compulsive disorder
* Investigational drugs within 30 days of baseline
* Known allergy or hypersensitivity to St. John's Wort
* Currently in behavior therapy for obsessive compulsive disorder

ALL INQUIRIES WILL UNDERGO A PHONE SCREENING TO DETERMINE WHETHER THEY MEET ELIGIBLITY REQUIREMENTS.
Safety of Exposure to Natalizumab During Pregnancy

Multiple sclerosis (MS) preferentially affects young adults with a female predominance. MS is not associated with an increased risk of complications or abnormal pregnancy outcomes. Nevertheless, disease-modifying therapies can have a teratogenic effect. Discussions about discontinuation should be made with a view to or upon discovery of pregnancy, taking into account the risk of untreated relapses and the risk of toxicity to the fetus.

Natalizumab (NTZ) is a humanized anti-alpha4-integrin monoclonal antibody used as a treatment for highly active relapsing-remitting MS (RRMS). When it is stopped, there is frequent reactivation of the disease with possible relapses and a rebound effect could occur. At present, depending on the center, attitudes of neurologist may vary and 3 main scenarios can be observed: Pregnancy and postpartum under NTZ (group1), Pregnancy partially under NTZ (with or without immunomodulator (IM) supplementation, group 2), or NTZ stopped before pregnancy (with or without IM supplementation, group3).

The first part of the BABYZUMAB study, a retrospective study of Natalizumab exposure during pregnancy, analysed the comparison the clinical activity of the disease (annualized relapse rate) according to these 3 scenarios of NTZ treatment The investigators analyzed the annual relapse rate (ARR) during a two-year period (9 months before and 15 months after the beginning of the pregnancy) in 117 patients identified in the OFSEP database. The investigators showed that the risk of relapses was four times higher in Group 2 versus Group 1 (p=0,014) and six times higher in Group 3 versus Group 1 (p=0,001).

In the literature, there are few studies of newborns from NTZ-exposed pregnancies. No specific pattern of birth defects has been found, but mild to moderate transient thrombocytopenia and anemia have been reported in infants born to NTZ-exposed mothers in the third trimester of pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years at the index date (date of pregnancy onset) of data collection,
* RRMS according to McDonald's 2017 criteria (Thompson et al., 2018)
* Affiliated person or beneficiary of a social security scheme.
* followed up at one of the participating centers (OFSEP centers)
* NTZ exposure during pregnancy according to 3 pre-defined sub-groups: continuation of NTZ throughout pregnancy and postpartum (Group 1), exposure during the first trimester (Group 2) exposure during the first and the second trimester (Group 3).
* Participants capable of expressing non objection
* French-speaking, without comprehension disorders

Exclusion Criteria:

* Patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)
CyberKnife for Unresectable Renal Tumors

This is a dose escalation study using the CyberKnife radiotherapy device for small surgical or medically untreatable renal tumors. Patients with renal tumors 5cms or less in diameter will be accrued onto this study. The ability of CyberKnife to ablate these renal tumors and maintain renal function with dose escalation will be assessed.

The CyberKnife Robotic Radiosurgery System is a unique radiosurgical system capable of treating tumors anywhere in the body noninvasively and with sub-millimeter accuracy. The CyberKnife System delivers radiation using a precise targeting methodology allowing a focal treatment margin around the target, thus limiting the volume of adjacent tissue receiving high doses radiation. This in turn allows the delivery of high doses of radiation to the prostate over a short series of treatments.

Eligibility Criteria:
Inclusion Criteria:

* Tumor size 5 cm or less
* Radiographic evidence of malignancy or Histologically verified primary renal malignancy.
* If the kidney biopsy is inconclusive but the radiologist determines that the tumor based on the CT/MRI is highly suspicious for cancer, you may participate
* Patients with highly suspicious lesions on CT or MRI
* One -three gold fiducials placed in or around tumor
* Contradiction or patient refusal to partial or complete nephrectomy
* Age 18 or greater
* KPS score 70 or greater

Exclusion Criteria:

* Irreversible coagulopathies that preclude fiducial placement
Comparison of the Intubation Condition Between Two Different Types of Video Laryngoscope Blades

The present study compares two different types of videolaryngoscope blade, which is a channeled and non-channeled blade. The purpose of the study is to investigate the effect of the type of videolaryngoscope blade on the intubation condition.

In tracheal intubation for general anesthesia, one of the two types of the blade during a video laryngoscopy can be used, one is a channeled blade that has a channel for tracheal tube launching, the other is a non-channeled blade. In the present study, the outcomes by using two types of the videolaryngoscope blade such as the intubation condition, intubation time, first-pass rate, and the incidence of intubation-related complications were compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving tracheal intubation for general anesthesia
* Patients with physical status 1, 2, or 3 by American Society of Anesthesiologists Physical Status.

Exclusion Criteria:

* Body mass index \<18.5 kg/m2 or \>35 kg/m2
* Patients with a history of airway surgery
* Patients with increased risk of aspiration
* Patients who have any pathology (polyp, tumor, or inflammation) in the upper airway and larynx
Subcutaneously CM310/Placebo in Patients With Chronic Rhinosinusitis With Nasal Polyposis (CROWNS-1)

This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, PK, PD and immumogenicity of CM310 in comparison to placebo in addition to a background treatment of mometasone furcate nasal spray (MFNS) in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).

The study consists of a Screening/run-in Period (up to 4 weeks), a Randomized, Double Blind Treatment Period (16 weeks, till End-of-Treatment Visit) and a Safety Follow-up Period (8 weeks, till End-of-Study Visit).

56 patients who meet eligibility criteria will be randomized 1:1 to receive either CM310 300mg or matched placebo subcutaneously every two weeks (Q2W) for a total of 8 times. All patients will receive MFNS on a daily basis as a background treatment throughout the study. MFNS is required to use no less than 14 days during Screening/run-in Period.

Central reading will be implemented to nasal endoscopic nasal polyp score (NPS) , CT scans to Lund-Mackay score and volume of the involved area of nasosinusitis on 3D-construction images, and nasal polyp biopsy tissue analysis to eosinophil counts \& percentage.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral CRSwNP.
* Prior treatment with systemic corticosteroids (SCS), and/or contraindicate to or intolerance to SCS, and/or with prior surgery to nasal polyps.
* Stable dose of intranasal corticosteroids for at least 4 weeks before screening.
* Ongoing symptoms for at least 4 weeks before screening：1)Nasal congestion/obstruction; 2)Othe symptom, e.g., loss of smell or rhinorrhea.
* Bilateral NPS of ≥5 with a minimum score of 2 in each nasal cavity at screening and at baseline.
* NCS score of 2 or 3 at screening and at baseline.
* Eosinophilic level meets the one of the following criteria: 1) serum eosinophil count ≥6.9% (without concomitant asthma) or ≥3.7% (with concomitant asthma) at screening; 2) absolute count of ≥55 per high power field or percentage of ≥27% in eosinophil level from nasal polyps biospy tissue.
* Contraception.

Exclusion Criteria:

* Not enough washingout period for previous therapy, e.g., less than 10 weeks or 5 half-lives (whichever is longer) for IL-4Rα antagonists, less than 8 weeks or 5 half-lives for biologic therapy/systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy).
* concurrent disease, e.g., ongoing rhinitis medicamentosa, acute sinusitis, nasal infection or upper respiratory infection, allergic fungal rhinosinusitis, malignancy, uncontrolled chronic disease such as cardivascular diseases, tuberculosis, diabetes etc.
* Allergic or intolerant to mometasone furoate spray or CM310/placebo.
* Significant liver or renal dysfunction.
* Other.
Clinical Trial to Evaluate the Symptoms in Symptomatic Contact Lens Wearers Following Application of Intranasal Tear Neurostimulator Versus Control

This study will evaluate the increase in comfort and comfortable contact lens (CL) wear time associated with application of TrueTear (active intranasal neurostimulation) compared with application of TrueTear sham control (intranasal application which is not electrically active) in symptomatic CL wearers.


Eligibility Criteria:
Inclusion Criteria:

A person is eligible for inclusion if he/she

* In at least one eye, has a cotton swab nasal stimulation Schirmer test score at least 4 mm greater than 3 minute Schirmer with anesthesia basal score in the same eye at the Screening Visit
* Is an adapted soft contact lens wearer and currently wears lenses an average of at least 2 days per week, with an average minimum wearing time of 3 hours each day over the past month and is able and willing to wear lenses for at least 6 hours on four study day visits
* Has at least 20/40 visual acuity in both eyes with CL correction
* Is symptomatic according to Young's categorization

Exclusion Criteria:

* Refractive error surgery
* Chronic or recurrent epistaxis, coagulation disorders or other conditions that may increase the risk of bleeding
* History of nasal or sinus surgery
* Vascularized polyp, deviated septum or severe nasal airway obstruction at the Screening visit
* Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head