cyrilzakka/clinical-trials huggingface dataset:
Access Program With Denileukin Diftitox for the Treatment of Patients Currently Receiving Treatment With Commercially Available (Ontak)

The purpose of this study is to provide continued therapy with Denileukin diftitox (ONTAK) to patients who are currently on therapy and who have no other suitable treatment options, where therapy is requested by their physician.

The Access Program will be provided as long as appropriate according to the judgment of the provider. If Denileukin diftitox (ONTAK) becomes commercially available without restriction, then the access program will be discontinued.

Eligibility Criteria:
Inclusion Criteria:

To receive denileukin diftitox (ONTAK) under this protocol, the patient's physician must request this therapy for the specific patient. Patients may continue treatment with denileukin diftitox if they:

* Are currently on therapy with denileukin diftitox and require ongoing therapy to maintain control of their disease.
* Are willing and able to comply with all aspects of the Access Protocol
* Provide written informed consent to participate

Exclusion Criteria:

Patients are not eligible for the Access Program with denileukin diftitox if they:

• Are not currently on denileukin diftitox therapy
Pilot Study, Comparative, Single-center, Randomized, Crossover, Double-blind, Against Placebo, Testing the Effectiveness of Triheptanoin Oil in Alternating Hemiplegia of Childhood

The purpose of this project is to study the efficacy of triheptanoin oil in patients with Alternating Hemiplegia of Childhood (AHC) due to ATP1A3 gene mutation.

The clinical spectrum of Alternating Hemiplegia of Childhood (AHC) is wide and characterized by the association of permanent and paroxysmal (palsy, dystonia, ocular, epileptic, dysautonomic events) neurological events, with onset in childhood. Most of AHC patients carry mutations in the ATP1A3 gene. This gene encodes the Na+/K+ ATPase witch is a transmembrane ion pump generating chemical and electrical gradient of sodium and potassium across the plasma membrane. Those paroxystic events in AHC patients with mutations in the ATP1A3 gene could be associated with a glucidic/energetic metabolism or intracerebral excitability disorder.

Triheptanoin is a triglyceride, whose derivatives pass the blood - brain barrier and enhance the Krebs cycle functions. Triheptanoin could therefore allow energy supply to the brain, which is essential for the functioning of the Na+/ K+ ATPase that consumes a significant amount of energy in the brain.

The investigators goal is to do a pilot study to test the effectiveness on paroxystic manifestations and the safety of triheptanoin in a small group of patients with Alternating Hemiplegia of Childhood secondary to ATP1A3 mutations.

Eligibility Criteria:
Inclusion Criteria:

* AHC with mutation in ATP1A3 gene
* Age ≥ 15 years and 3 months
* ≥ 6 neurological paroxystic events during the last 3 months prior to the beginning of the study
* No specific diet
* Covered by french social security
* Patients who freely agree to participate in this study and understand the nature, risks and benefits of this study and give their written informed consent. (In addition to the requirement for the consent of parents or the legal representative, adolescents can provide additional informed consent to participate in clinical trials)

Exclusion Criteria:

* Age \< 15 years and 3 months
* Evidence of psychiatric disorder
* Comorbid medical condition that would render them unsuitable for the study, e.g. HIV, diabetes
* Pregnant or parturient or lactating women
* Absence of double effective contraception at the women old enough to procreate
* Unwillingness to be informed in case of abnormal MRI
* Absence of signed informed consent
* No covered by french social security
* Persons deprived of their liberty by judicial or administrative decision
* Person subject to an exclusion period for another research
* Subjects with exclusion criteria required by french law
Core Semantic Systems TMS

This study examines the time course of activation of the left anterior temporal lobe (ATL) during lexical processing using Transcranial Magnetic Stimulation (TMS).

This study investigates the activation time of the anterior temporal lobe (ATL) region during lexical processing. Participants will perform three tasks: lexical decision, semantic decision (divided into noun and verb semantic decision), and number judgment.

Lexical Decision Task: Participants will be shown words and pseudowords (e.g., excaid). Participants have to decide if the presented stimulus is a real word or a pseudoword.

Semantic Decision Task: Participants will determine if the stimulus word refers to an action or an object that can be manipulated using the hand or arm.

Half of the stimuli will be nouns, constituting the first semantic decision task with objects, and the other half will be verbs, constituting the second semantic decision task with actions.

Number Judgment Task: Participants will decide if a presented number was divisible by four (e.g., 64) or not (e.g., 69). The stimuli will include numbers with either two or three digits.

For each task, we will collect accuracy and reaction time (RT) data. The primary analyses concern the RTs, but accuracies will also be examined in secondary analyses.

A single pulse TMS will be applied at three different time points: -100 ms, 150 ms, and 400 ms after the onset of the stimulus item. A Magstim BiStim² stimulator with a figure-8 coil will be used. The resting motor threshold (RMT) will be defined as the minimum intensity required to stimulate the motor cortex, eliciting a contraction of the abductor pollicis brevis in at least 5 out of 10 trials. The coil will be positioned at a 45-degree angle along the parasagittal line on the presumed motor cortex area for the APB muscle and adjusted in different directions to find the optimal motor hotspot. Intensity will be between 100% and 120% of resting motor threshold as tolerated by the participant.

The effect of TMS on the response time (RT) at different time points will be examined. TMS will be applied at the left anterior middle temporal gyrus at 10 mm posterior to the tip of the temporal pole. A structural MRI scan will be collected prior to the TMS, which will be used in localizing The target spot. A BrainSight neuronavigation system will be used, with the MRI scan collected before, to localize the target location on the scalp. The tasks will last approximately 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be within the ages of 18 to 40
* Native speakers of English

Exclusion Criteria:

* Potential participants with a clinically reported history of dementia, alcohol abuse, psychiatric or neurological disorders, traumatic brain injury, or extensive vision or hearing problems that prevents them from performing the tasks
* Contraindication to TMS, determined by a standard TMS screening form
* Contraindication to MRI, determined by a standard MRI screening form
* Left handed participants
Gingival Augmentation and Root Coverage With Superficial and Deep Cut Acellular Dermal Matrices

This entire protocol involves procedures that are standard care and will randomize subjects to of one two routine care procedures. Patients needing root coverage for gingival recession will be enrolled.

Each subject will be randomized to one of the treatments for the first side and the contralateral side will receive the other treatment. No risk or benefit is expected from being assigned to either group as both procedures are both standard care. In both groups, a commercially available allograft (ADM-D or ADM-S) will be used.

Allocation of subjects into test group or control group will be based on numbers drawn from a stack of sealed envelopes.

Grafting teeth with gingival recession is often done to improve esthetics and tooth sensitivity as well as prevent recession from progressing. When recession coverage procedures are done, a soft tissue graft material is inserted between the gums and the tooth to help decrease the amount of root exposure. This material is obtained from a donor and may originate from a deeper or shallower layer of the donor skin. The study team seek to determine if the origin of the graft material (deep or shallow) influences the amount of root coverage achieved.

Eligibility Criteria:
Inclusion Criteria:

* Patients between age 18 and 89
* Patients needing root coverage procedures for gingival recession in one or more teeth in the same arch bilaterally (split mouth)
* Patients must be nonsmokers, former smokers, or current smokers who smoke \<10 cigarettes per day, by self-report.
* Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non- pregnant women of child-bearing potential.

Exclusion Criteria:

* Patients who disclose that they will not be able to cooperate with the follow-up schedule.
* Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report)
* Pregnant women or women intending to become pregnant during study period.
* Smokers who smoke \> 10 cigarettes per day
Social Support and Stress Reduction for Caregivers of Young Adults With IDD

The objective of this study is to evaluate the feasibility and stress reduction impacts of a yoga and support group intervention on caregivers of individuals with intellectual and developmental disabilities.

This is a single arm longitudinal trial. We will recruit up to 40 caregivers of young adults with intellectual and developmental disabilities (IDD). This is a 12-week social support, resources, and stress reduction intervention delivered in person to a group of caregivers of young adults IDD. Participants will be asked to attend one 2 hour group session each week. All sessions will have a 1-hour discussion on resources and social support and 1-hour of yoga. All yoga sessions will be taught by 200 Registered Yoga Teacher certified instructors. Outcome assessments will be collected at baseline and after the 12-week intervention.

Eligibility Criteria:
Inclusion Criteria:

* 1) caregiver of a young adult with IDD 2) self-reported ability to participate in a yoga class with no contraindications to participation.

Exclusion Criteria:

* 1) Actively participating in another health lifestyles interventional research study.
Cerebrospinal Fluid Biomarkers for Brain Tumors

This study examines cerebrospinal biomarkers in patients with brain tumors. A biomarker is a measurable indicator of the severity or presence of your disease state. Collecting and storing samples of cerebrospinal fluid from patients with brain tumors to study in the laboratory may help doctors develop new strategies to better diagnose, monitor, and treat brain tumors.

PRIMARY OBJECTIVE:

I. To collect cerebrospinal fluid (CSF) samples that can provide a resource to the research community for biomarker discovery in patients with gliomas.

SECONDARY OBJECTIVE:

I. Evaluate the feasibility of serial CSF sampling from patients with brain tumors for longitudinal evaluation of tumor biomarkers.

OUTLINE:

Patients undergo collection of CSF samples via lumbar puncture at least 2 times. Patients may undergo additional collection of additional CSF samples if they choose.

After completion of study treatment, patients are followed up periodically.

Eligibility Criteria:
Inclusion Criteria:

* Any evidence of neoplasm involving the central nervous system (CNS) or its adjacent structures in contact with CSF. Such lesions may include but are not limited to intra-axial or extra-axial lesions, which could be benign, malignant or as yet undefined, involving the brain, spine, meninges, nerves, or vasculature or supporting structures
* Subjects must be 18 years of age or older

Exclusion Criteria:

* Patients who are under 18 years of age or are a member of a vulnerable population will be excluded from this study
* Pregnant women or women who may be pregnant are specifically excluded from study participation
* Exception will be granted for patients with diminished capacity to consent if a legally authorized representative is available
* Patients without clinical or radiographic evidence of a potentially neoplastic CNS lesion will be excluded
* Patients with an inability or unwillingness of individual or legal guardian/representative to give written informed consent will be excluded
* Any patient for whom a clinical contraindication exists to the intended route of CSF access will be excluded. For example, a patient with a large posterior fossa mass lesion at risk of herniation, or a patient with coagulopathy, or other contraindication to lumbar puncture would not be eligible to participate via use of lumbar puncture for CSF access
Safety and Feasibility of Human Umbilical Cord Mesenchymal Stem Cell-Derived Secretome in the Treatment of Liver Cirrhosis: a Comprehensive Evaluation of Fibrosis Reduction, Immunomodulation, and Hepatic Regeneration: a Single Center, Randomized, Phase I Clinical Trial

The goal of this clinical trial is to learn if Human Umbilical Cord Mesenchymal Stem Cell (HUCMSC) derived secretome injection is safe and effective in patient with liver cirrhosis. The main questions it ams to answer are:

1. How safe is secretome Injection as an adjuvant therapy for liver cirrhosis patients?
2. How effective is secretome injection in liver fibrosis 6 months after injection?
3. Does secretome injection improve liver function after 6 months after Injection?
4. Does secretome injection affect Child Turcotte Pugh score?
5. How does secretome affect pro inflammatory and anti Inflammatory cytokine in patient with liver cirrhosis?
6. How does secretome injection affect the quality of life in live cirrhosis patient?
7. What is the relationship between secretome injection and encephalopathy? Researchers will compare secretome injection group (patients who recieve secretome injections) to best practice treatment group (patient who receive supportive treatment including hepatoprotector and ursodeoxycolic acid)

Researchers will compare the intervention group (patients who are injected with HUCMSC derived secretome) and control group (patients who are only monitored and given their usual drugs)

Patients will:

Be injected with secretome or take hepatoprotector and ursodeoxycolic acid every 2 weeks for 4 months. Do several test such us fibroscan, stroop test, psychometric hepatic encephalopathy score, short form 36 questionnaire, IL-6, TNF alfa and blood test for albumin, SGOT, SGPT, direct bilirubin, indirect bilirubin, INR, creatinine, ureum, hemoglobin, hematocrite, leukocyte, and thrombocyte.

Visit the clinic once every two weeks to receive drugs and treatment for 4 months.

Follow up visit to review treatment progress on 3rd months (2 weeks post treatment), 7th months (3 months post treatment),10th months (6 months post treatment)


Eligibility Criteria:
Inclusion Criteria:

* Age above 17 years, both men and women
* Patient is willing to participate and sign informed consent
* Patient is diagnosed with liver cirrhosis confirmed by clinical examination and diagnostic imaging
* Liver cirrhosis patient with Child-Pugh Class B
* Patient is in a stable condition without life threatening complications such as active gastrointestinal bleeding, severe infection, severe renal failure (eGFR\&amp\>30) at time of registration
* Patient is not receiving experimental drugs for liver cirrhosis for the past 6 months
* Patient is able and willing to comply with research protocol including follow up visits and evaluations

Exclusion Criteria:

* Patient with uncontrolled psychiatric disorders
* Patient who is diagnosed with hepatic or non- hepatic malignancy
* Lactating and pregnant patient
* Patient who has allergy or hypersensitivity reaction towards secretome
Adjustable Strabismus Surgery

Strabismus, whether congenital or acquired, is a common visual and cosmetic problem, especially for the young. Adjustable suture strabismus surgery is not in vogue in our country. This technique gives the surgeon a second attempt to provide a better outcome for the patients.


Eligibility Criteria:
Horizontal, vertical and complex strabismus cases (sensory, paralytic, nystagmus, monocular elevation deficit and dissociated vertical/horizontal deviation) were included, along with patients with a previous history of strabismus surgery.

Myasthenia gravis was excluded along with noncooperative children; less than 7 years of age. Those who did not return for a one year follow up also had to be excluded.
Circulating microRNAs as Disease Markers in Pediatric Cancers

MicroRNAs are small molecules which have recently been discovered in cells. They are known to be responsible for the normal development of cells and when they are disrupted can contribute to the development of cancer. Many previous studies have been done evaluating the expression of microRNAs in normal tissues as well as a wide variety of cancers.

Recently, microRNAs from tumor cells have been detected circulating in the blood of patients with cancer. This presents a novel opportunity to use microRNAs in the blood as an early predictor of cancer as well as a marker of response to therapy. No previous studies have been performed evaluating microRNAs in the blood or cerebrospinal fluid of patients with childhood cancers. We propose a feasibility study to evaluate the presence of microRNAs in the blood and cerebrospinal fluid of patients with central nervous system tumors, leukemia and lymphoma who are currently on chemotherapy and undergoing blood draws, lumbar punctures and/or reservoir taps for routine clinical care. If we're able to identify circulating microRNAs in this population of pediatric patients, we will build upon this data in proposing a future study.


Eligibility Criteria:
Inclusion Criteria:

* All children who are in treatment for leukemia, lymphoblastic lymphoma and central nervous system tumors
* age: greater than 3 years and less than or equal to 21 years of age
* Patients must be in a phase of their treatment during which routine blood draws, lumbar punctures or CSF sampling from Ommaya reservoirs are required for treatment of their cancers.

Exclusion Criteria:

* Patients who have completed treatment and do not require routine blood draws and/or lumbar punctures
* Patients who are considered too ill to participate as determined by their treating physician
* Patients with a known genetic condition that predisposed them to the development of cancer.
Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function.

This trial is conducted in Europe. The aim of this trial is to investigate the effect of abnormal liver (hepatic) function on the amount of trial drug getting into the body and removal of the drug from the body (this is called pharmacokinetics).

In this trial the participants will receive three subcutaneous (under the skin) injections of the trial drug somapacitan. Somapacitan is a long-acting growth hormone analogue (a drug similar to human growth hormone) intended for once-weekly subcutaneous administration.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-75 years (both inclusive)
* Body mass index of 18.5-39.9 kg/sqm (both inclusive)
* Subjects with normal hepatic function or hepatic impairment (mild or moderate)

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice) for at least 16 days after the last trial product administration
* Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) or male who is not willing to refrain from donating semen for at least 16 days after last trial product administration
* Any blood draw in excess of 25 mL in the past 30 days, or donation of blood or plasma in excess of 400 mL within the 90 days preceding screening
* Any disorder, except for conditions associated with hepatic impairment in the group of subjects with compromised hepatic function, which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
Induction of Mild Hypothermia Following Out-of-hospital Cardiac Arrest

The overall goal of this study is to determine whether initiating hypothermia in cardiac arrest patients as soon as possible in the field results in a greater proportion of patients who survive to hospital discharge compared to standard prehospital/field care.

In this study we will randomize 1,200 cardiac arrest patients who have return of spontaneous circulation (ROSC) to hypothermia with rapid infusion of 2 liters of 4oC Normal Saline IV solution over 20 to 30 minutes, IV sedation and muscle paralysis or to standard of care following ROSC.

The primary objective of this study will be to determine whether induction of mild hypothermia using an infusion of cold normal saline will improve the proportion of patients who survive and are discharged awake from the hospital.

Hypothesis: In cardiac arrest patients who achieve ROSC in the field, initiation of hypothermia by infusion of cold normal saline will result in a greater proportion of cardiac arrest patients discharged awake from the hospital compared to standard care.

Eligibility Criteria:
Inclusion Criteria:

* successful resuscitation from out-of-hospital cardiac arrest by paramedics, defined by having a palpable pulse

Exclusion Criteria:

* traumatic cause for cardiac arrest
Prediction of Chronic Renal Disease After Acute Kidney Injury in the Intensive Care Unit

The study aims to develop and validate a prediction score of chronic renal disease occurrence within 3 years after ICU discharge in patients who suffered an acute kidney failure during ICU stay and recovered normal renal function at 90 days following their discharge.

The primary study outcome is the incidence of chronic renal disease within the first 3 years after ICU discharge, defined by a lower glomerular filtration rate (GFR) under 60 mL/minute/1.73m2.

As second objectives, the study aims to:

* Evaluate the GFR decline in patients who had an underlying chronic kidney disease.
* Evaluate factors associated with a persistent decreased GFR at day-90.
* Characterization the clinical and biological phenotype of chronic renal disease in these patients.
* Evaluate treatments provided to these patients according to CKD occurence.
* Evaluate the rate of cardiovascular and thrombo-embolic morbidity-mortality.
* Assess the quality of life every year for 3 years.
* Evaluate the medico-economic burden of CKD.

Eligibility Criteria:
Inclusion Criteria:

* Patient ⩾ 18 years;
* Patient suffering an acute kidney injury (defined by AKIN score ⩾1) during ICU stay;
* Patient discharged alive from the ICU;
* Patient's signed consent obtained;
* Patient covered by a healthcare insurance.

Exclusion Criteria:

* Pregnant or breastfeeding woman;
* SOFA score \< 1 (except for kidney assessment) at time of ICU admission;
* End-stage of renal failure or dialysis treatment or renal transplantation prior to ICU admission;
* Patient treated with dialysis at ICU discharge;
* Immunosuppressive treatment prior to ICU admission;
* Patient under legal incapacity (tutor or guardian protection);
* Being unable to follow-up of the study;
* Life expectancy expected shorter than 90 days;
* Refusal to participate in the study;
* Patient's main address is outside of Il de France region for the centers in this region;
* Patient \< 18 years;
* Patient not affiliated to national social security scheme;
* Patient deprived of liberty by judicial measure.