cyrilzakka/clinical-trials huggingface dataset:
Expanded Access Program: Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA®) in Combination With Polychemotherapy in Patients Under 55 Years Old With Acute Lymphoblastic Leukemia (ALL) at Risk to Receive Other Formulation of Asparaginase

Early Access Program to provide L-asparaginase encapsulated in Erythrocyte (GRASPA®) for patient unable to receive any other form of Asparaginase.

Some patients can not be eligible to other clinical trials / program sponsored by Erytech Pharma but could have a benefit to be treated with GRASPA. Following discussion with French regulatory authorities, it has been suggested to propose access to GRASPA to patients unable to receive any other form of L-asparaginase and not eligible to the ongoing study or other program. This exploratory study should allow it in an "Expended Access Program" framework.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ALL de novo or in relapse or refractory
* Eligible to a chemotherapy treatment including L-asparaginase
* Known contraindication and/or at risk of toxicity to other L-asparaginase formulation according to investigator opinion based on information available
* Patient under 55 years old
* Patient informed and consent provided (the 2 parents need to consent for children).

Exclusion Criteria:

* Patient unable to receive GRASPA due to general or visceral conditions

  * Serum creatinine ≥ 2 x ULN unless related to ALL
  * ALT or AST ≥ 3 x ULN unless related to ALL
  * Active clinical pancreatitis any grade or pancreatic enzyme elevation ≥ 1.5 ULN
  * Other serious conditions according to investigator's opinion.
* Absence of documented serological test for HIV, B and C hepatitis
* History of grade 3 transfusional incident or any contraindication to receive blood transfusion
* Patient under concomitant treatment likely to cause hemolysis
* Presence of specific anti-erythrocyte antibodies preventing from getting a compatible erythrocyte concentrate for the patient.
* Patient undergoing yellow fever vaccination.
* Patient under phenytoin treatment.
* Women of childbearing potential without effective contraception as well as pregnant or breast feeding women.
* Patient already included in another clinical trial
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy

The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of brivaracetam (BRV) administered intravenously (iv) in subjects \>= 1 month to \< 16 years of age with epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female from \>= 1 month to \< 16 years of age. For subjects who are \< 1 year from birth and who were preterm infants, the corrected gestational age should be used for this entry requirement
* Weight \>= 3 kg (6.6 lbs)
* Diagnosis of epilepsy
* Acceptable candidate for venipuncture and intravenous (iv) infusion
* Treatment with \>=1 anti epileptic drug (AED; including BRV) without a change of dose regimen for at least 7 days prior to Screening
* No treatment with vagus nerve stimulation (VNS), OR the subject is being treated with VNS and the settings have been constant for \>=7 days prior to Screening
* For female subjects: not of childbearing potential, OR of childbearing potential and not sexually active/negative pregnancy test, OR of childbearing potential and sexually active/negative pregnancy test/uses medically acceptable contraceptive methods

Exclusion Criteria:

* Subject has previously received iv Brivaracetam (BRV) in this study
* Subject is being treated with BRV at a dose \>5mg/kg/day (rounded) or \>200mg/day for subjects with body weights \>40kg
* Subject requires or is likely to require a change in concomitant antiepileptic drug(s) (AED\[s\]), dose of concomitant AED(s), or formulation of AED(s) during the 7 days prior to the intravenous (iv) pharmacokinetic (PK) Period
* Subject is likely, in the opinion of the Investigator, to require rescue medication during the Initiating Oral BRV (IOB) Treatment or iv PK Periods
* Subject has experienced generalized convulsive status epilepticus in the 28 days prior to Screening or during the Screening Period
Neurorehabilitation After Traumatic Brain Injury: Functional Magnetic Resonance Imaging Study

The current study aims to better understand cerebral plasticity mechanisms to optimize non-pharmacological rehabilitation approaches for patients with traumatic brain injury.

Cognitive impairment following moderate to severe traumatic brain injury are usual. To date, cognitive rehabilitation effects on cerebral plasticity and quality of life remain unproven essentially because of methodological biases. Transcranial Direct Current Stimulation is an innovative technique of noninvasive brain stimulation that showed efficacy in literature. The current study want to better understand cerebral plasticity mechanisms to optimize non-pharmacological rehabilitation approaches for patients with traumatic brain injury. The aim in the present study is to assess the effect of rehabilitation combined with Transcranial Direct Current Stimulation provided to traumatic brain injury patients with cognitive impairment on cerebral plasticity using functional magnetic resonance imaging. Effects of rehabilitation and Transcranial Direct Current Stimulation will be observed on functional magnetic resonance imaging activation maps acquired. Relationship between attentional outcomes measured in the neuropsychological assessment and activation extend will be explored.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe traumatic brain injury
* more than 3 months since the onset
* Attentional disorders (PASAT test (score ≤ centile 10) and/or CANTAB test (≤ -2 standard deviation)
* Women having contraceptive treatment (for the magnetic resonance imaging exam)

Exclusion Criteria:

* inability to undergo magnetic resonance imaging scan
* No attentional impairment (PASAT ≥ centile10)
* Severe depression
* Neurological disease
* Major cognitive impairment (aphasia, neglect)
* Drugs addiction
* Pregnant women and women having no contraceptive treatment
A Prospective Study of Brain Network Activation (BNA) Changes in High School Athletes Following Concussion

The main purpose of this study is to prospectively examine changes in Brain Network Activation(BNA)following concussion in high school athletes. In addition, the study will examine the relationship between changes in BNA to symptoms, cognitive performance and vestibular function from baseline to 1-7, 8-14 and 15-21 day post injury intervals in high school athletes with concussion.


Eligibility Criteria:
Inclusion Criteria:

* Aged 13-18 years
* Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments
* Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self)

Exclusion Criteria:

* Current or history of TBI (i.e., Glasgow Coma Scale \<13) or brain surgery
* Current or history of any psychiatric disorder (except ADD/ADHD), e.g., depression, bipolar disorder, schizophrenic disorder
* Substance abuse within the last year
* Current or history of Special education, e.g., reading disorder (dyslexia), writing disorder (dysgraphia), math disorder (dyscalculia), nonverbal learning disorder
* Current or history of any Neurological disorder, e.g., epilepsy, seizures
* History of any medication affecting CNS within the last year, e.g., antidepressants, anticonvulsants, Ritalin, first generation antihistamines, etc.
* Current or history of Significant sensory deficits such as deafness or blindness
* Current or history of Clinically significant abnormal laboratory values or ECG
* A concussion within the last year
* Current or history of residual symptoms or deficits related to a previous concussion
* Diagnosis of autistic spectrum disorders, e.g., Asperger's syndrome, High functioning Autism, PDD
* Currently with lice or open wounds on scalp
* Long and thick hair that prevents the proper administration of an EEG cap
Bilateral Elective Neck Dissection in Salvage Total Laryngectomy

The aim of this study is to evaluate the role of elective bilateral neck dissection in patients with clinically negative lymph nodes (cN0) who underwent salvage total laryngectomy, by estimating the prevalence of histologically positive occult lymph nodes (pN+). Secondary objective will be the assessment of complication rate and the evaluation of 5-year Overall Survival (OS) and 5-year Disease-Specific Survival (DSS) in these patients.


Eligibility Criteria:
Inclusion criteria

-patients affected by recurrent laryngeal cancer after primary treatment failure (surgery or radiotherapy or chemoradiotherapy), with no clinical or radiological evidence of lymph node metastasis in the neck (cN0),who underwent salvage total laryngectomy and concomitant bilateral elective neck dissection (levels II, III, IV and VI).

Exclusion Criteria:

* patients who received other salvage laryngeal resection such as open partial horizontal laryngectomy, endoscopic partial laryngectomy, or who did not undergo bilateral selective neck dissection.
Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery

Single center randomized study to test whether a prophylactic tricuspid annuloplasty at the time of mitral valve procedure can improve clinical and echocardiographical outcomes.

The optimal management of functional tricuspid regurgitation (FTR) in the setting of mitral valve operations remains controversial. The current practice is both center- and surgeon-specific with guidelines based on non-randomized data. A prospective randomized trial was performed to evaluate the worth of less-than-severe FTR repair during mitral valve procedures.

A single center randomized study was designed to allocate patients with less-than-severe FTR undergoing mitral valve surgery to be prophylactically treated + tricuspid valve annuloplasty (TVP- or TVP+). These patients were analysed using longitudinal cardiopulmonary exercise capacity, echocardiographic follow-up, and cardiac magnetic resonance (CMR). The primary outcome was more than mild tricuspid regurgitation (TR) recurrence with vena contracta \>3mm. Secondary outcomes were maximal oxygen uptake (VO2 max) and right ventricular (RV) dimension and function.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing mitral valve surgery with less than sever tricuspid insufficiency

Exclusion Criteria:

* presence of pacemaker lead through the tricuspid valve
* acute endocarditis
* minimally invasive approach
* Functional mitral valve insufficiency
Combined Inhibition of Dipeptidyl Peptidase IV (DPIV/CD26) and Aminopeptidase N (APN/CD13) in the Treatment of Psoriasis

The major objective of this study is to evaluate the therapeutic effect of a topical treatment simultaneously inhibiting Dipeptidyl Peptidase IV and Aminopeptidase N (IMTM #IP10.C8) in patients with mild to moderate psoriasis of the skin


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years of age at pre-study and
2. Diagnosis of plaque type psoriasis at least 3 month prior to enrolment
3. Mild to moderate plaque type psoriasis with at least 2 plaques of approximately 15cm2 for which topical treatment is indicated
4. Patients must be able to give written informed consent before any trial-specific procedures are performed (see Section 12.2

Exclusion Criteria:

1. Other type of psoriasis (e.g. erythrodermic, guttate or pustular) at enrolment
2. Drug induced psoriasis at enrolment (e.g. lithium)
3. Pregnant or lactating women, patients (men or women) planning a pregnancy during the duration of the study
4. Systemic therapy affecting PASI or phototherapy for a period of 4 weeks prior to enrolment
5. Topical therapy affecting PASI for a period of 2 weeks prior to enrolment
6. Treatment with biologic agents affecting PASI for a period of 3 months prior to enrolment
7. Systemic treatment with immunosuppressive agents (e.g. methotrexate, cyclosporin) or treatment with lithium, anti-malaria medication, or intramuscular gold application for a period of 4 weeks prior to enrolment
8. Having a history of or an ongoing uncontrolled serious or recurring bacterial, viral, fungal, or atypical mycobacterial infection
9. Having a severe medical condition that, in the judgment of the investigator, would jeopardize in any way the subject's safety following exposure to study drug
10. Having the presence or history of malignancy, including lymphoproliferative disorders. Subjects with a history of fully resolved basal or squamous cell skin cancer may be enrolled
Tobacco Cessation Via Doctors of Chiropractic

The purpose of the study is to develop an office-based tobacco intervention for chiropractic patients.

Medical doctors, nurses, dentists, and dental hygienists have been shown to be effective in helping their patients quit tobacco. However, Doctors of Chiropractic (DCs) have not been utilized in this role. DCs can provide a unique channel for the conduct of tobacco interventions, but they currently receive little to no training in these techniques (Hawk \& Evans, 2005). Doctors of Chiropractic are increasingly concerned with patients' use of cigarettes and smokeless tobacco. The chiropractic team provides educational and preventive services to patients, and the office visit can provide an extended opportunity to talk to patients about their tobacco use (Hawk, Long, Perillo, \& Boulanger, 2004; Rupert, 2000). Given the health effects associated with chronic tobacco use, the chiropractic visit provides a "teachable moment" during which the DC can relate current health problems to tobacco use and provide brief counseling to patients who use tobacco (Gordon \& Severson, 2001; Vogt, Lichtenstein, Ary, et al., 1989).

In the proposed developmental study, eight chiropractic clinics will participate in the design, implementation, and evaluation of an office-based tobacco cessation intervention. Adapted from previous office-based intervention protocols, the intervention will be based on Cognitive Learning Theory (Bandura, 1997) and the Clinical Practice Guidelines (Fiore, Bailey, Cohen, et al., 2000) and will also incorporate Motivational Interviewing techniques (Miller \& Rollnick, 1991). Finally, using the RE-AIM framework (Glasgow, Vogt \& Boles, 1999), we will assess individual-, clinic-, and organization-level variables that may affect the delivery of treatment for tobacco dependence, the implementation and maintenance of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Doctors of Chiropractic currently licensed by the Oregon Board of Chiropractic Examiners and actively engaging in patient care, their Chiropractic Assistants, and their Chiropractic patients who use tobacco

Exclusion Criteria:

* Chiropractic patients under the age of 18
Differential Pressure Distribution Orthosis by 3D Printing Process in the Treatment of Post-burn Hypertrophic Scarring

This is a pilot, single-center, feasibility study to evaluate a new 3D printing method for ORDP design.

To our knowledge, there is no technical or clinical evaluation of ORDPs, particularly in the treatment of hypertrophic scars. The aim of our study is therefore to assess the feasibility of an innovative method of designing ORDPs for the curative treatment of post-burn hypertrophic scars, using a 3D printing process, and to describe the procedures (production time and cost).


Eligibility Criteria:
Inclusion Criteria:

* Adult Patients aged \> 18 years old
* Patient with at least one hypertrophic burn scar in the process of healing localized on a skin area that can benefit from a compression garment and requiring the use of an ORDP
* Patient able to give informed consent
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Patients under guardianship, curatorship or safeguard of justice
* Pregnant or breast-feeding women
Study to Compare Verbal Scores of Children Diagnosed With ASD Who Received Hyperbaric Treatment To Those Who Did Not

A child's ability to effectively communicate with peers, parents, and caregivers impacts their level of independence and quality of personal relationships. This retrospective study will compare the speech development of participants aged 2 - 17 years that received 40 sessions of HBOT at 2.0 ATA to those who had not. Both groups will have a verbal assessment every six months. There were 32 subjects in the HBO group and 33 subjects in the non-HBO group. The statistical analysis will focus on whether Hyperbaric Oxygen Therapy made a significant difference in Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP) or Assessment of Basic Language and Learning Skills (ABLLS) results.

Methods: This was a study designed to retrospectively determine any association between hyperbaric oxygen therapy (HBOT) and change in verbal scores in children with autism spectrum disorder (ASD). All children aged 2 to 17 years, diagnosed with ASD who completed a verbal test every six months (either Verbal Behavior Milestones Assessment and Placement Program or the Assessment of Basic Language and Learning Skills), received applied behavioral analysis at Oxford Recovery Center (ORC) were screened for inclusion, some of whom had elected to receive HBOT (at least 40 sessions for 60 minutes at 2.0 ATA).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with autism spectrum disorder by a qualified practitioner
* Obtained medical clearance for hyperbaric oxygen therapy
* Received applied behavioral analysis at Oxford Recovery Center
* Received two of the same age appropriate verbal test 6 months apart

Exclusion Criteria:

* History of seizure disorder
* Diagnosis of genetic or mitochondrial mutation
Optimizing Active Surveillance in Low-Risk Prostate Cancer: a Pilot Study

This is a pilot evaluation of a patient-centered intervention that enables providers to support men on active surveillance to maximize adherence. Conducted in urology practices, this pilot will measure key patient-reported, provider-reported, and implementation outcomes. Successful completion of this work will inform a subsequent multi-center effectiveness-implementation hybrid design trial and ultimately will improve low-risk cancer management by effectively engaging Primary Care Physicians (PCPs) in care delivery.


Eligibility Criteria:
Patient Inclusion Criteria:

* 55 years old or older
* Men diagnosed with low-risk prostate cancer currently on active surveillance
* Men who identify having a primary care provider
* Access and ability to use the Internet

Patient Exclusion Criteria:

* Men who are unable to read and/or speak English
* Men with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss)

PCP Inclusion Criteria:

* Identified by patient on baseline survey as their PCP

Urologist and Clinic Staff Inclusion Criteria:

* Clinicians or staff at a participating urology clinic, including but not limited to MDs, APPs, and nurses
Gatekeeper for Soiling and Gas Incontinence

Faecal incontinence has a broad spectrum of symptoms. Some patients only suffer commonly considered mild symptoms: gas incontinence and soiling, but patients' quality of life is significantly impaired. Although several treatments for faecal incontinence are available, this subgroup of patients are difficult to treat, and no therapeutic alternative has been clearly defined.

The aim of this study is to evaluate Gatekeeper™ treatment for this subgroup of patients with faecal incontinence, not studied before.

Consecutive case series single-centre study. Patients with mainly soiling and/or gas incontinence were treated with polyacrylonitrile prostheses


Eligibility Criteria:
Inclusion Criteria:

* patients older than 18 years old
* with at least 6 months of GI and/or soiling
* non-responding to conservative treatment and biofeedback.

Exclusion Criteria:

* complete solid and liquid FI
* common Bristol score \> 4
* malignant diseases
* chronic diarrhoea
* inflammatory bowel disease
* acute anorectal disease
* rectal prolapse
* neurological disease,
* obstructive defecation syndrome
* low anterior resection syndrome,
* previous pelvic radiation,
* any anaesthetic contraindication
* St. Mark's score \> 12
* external anal sphincter lesion \> 30º.
A Single-Arm Study to Evaluate Administration of Lebrikizumab by Participants or Caregivers in the Home Setting

This multi-center, single-arm study is designed to evaluate clinical experience of participants (or caregivers) administering lebrikizumab at home in participants with asthma. Eligible participants will receive four doses of subcutaneous (SC) lebrikizumab every 4 weeks (q4w) up to Week 12. Primary analysis visit occurs at Week 13. After study treatment, all participants will complete a 12 week safety follow up. All participants will get training for the administartion of lebrikizumab using the device.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 75 years at Week -1
* Asthma diagnosis for greater than or equal to (\>=) 12 months prior to Week -1
* Pre-bronchodilator forced expiratory volume in 1 second (FEV1) of \>=40% predicted at Week -1 or Week 0 (Day 1; prior to entering treatment phase), based on an established spirometry reference equations
* Competent and willing, as determined by the investigator, to independently administer lebrikizumab at home. The investigator needs to confirm that the participant (or caregiver) will be able to follow the instructions to administer lebrikizumab
* Able and willing to take home the pre-filled syringes of lebrikizumab at the conclusion of Week 0 (Day 1) and store these according to the requirements highlighted within the Instructions for Use (IFU) document.

Exclusion Criteria:

* History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
* Hospitalization for any reason, including acute exacerbation event, within 4 weeks prior to Week -1 or during the screening period
* Infection that required hopitalization, treatment with intravenous (IV) or intramuscular antibiotics within 4 weeks and oral antibiotics within 2 weeks prior to Week -1 or during screening
* Taken part in a previous clinical trial of lebrikizumab and discontinued from the trial prematurely or discontinued study drug prematurely due to an adverse event