cyrilzakka/clinical-trials huggingface dataset:
Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults

This is a double-blind, randomized, vehicle controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% compared to vehicle control cream in pediatric and adult subjects with atopic dermatitis.

This study is a 8-week double-blind, vehicle-controlled treatment study in which subjects will be randomized to receive tapinarof cream, 1% or vehicle cream once daily for 8 weeks. At the end of the 8-week study treatment, qualified subjects will have the option to enroll in an open-label, long-term extension study for an additional 48 weeks of treatment. Subjects who do not participate in the open-label, long-term extension study will complete a follow-up visit approximately one week after the end of treatment in this study.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects ages 2 and above with clinical diagnosis of AD
* Subject with atopic dermatitis covering ≥5% and ≤ 35% of the BSA
* A vIGA-AD score of ≥3 at screening and baseline
* An EASI score of ≥6 at screening and baseline
* Atopic dermatitis present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old
* Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods
* Must not be pregnant
* Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent

Exclusion Criteria:

* Immunocompromised at screening
* Chronic or acute systemic or superficial infection requiring treatment with systemic antibacterials or antifungals within one week prior to baseline visit
* Significant dermatological or inflammatory condition other than AD that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upper limit of normal (ULN).
* Screening total bilirubin \> 1.5x ULN
* Current or chronic history of liver disease
* Current or history of cancer within 5 years except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
* Subjects who would not be considered suitable for topical therapy
* Use of any prohibited medication or procedure within the indicated period before the baseline visit including other investigational product within 30 days or 5 half-lives of the investigational product (whichever is longer)
* History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion, may interfere with the subject's participation in the study, interpretation of results, or ability to understand and give informed consent.
* Pregnant or lactating females
* History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation
* Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001)
EEG Encephalopathy Patterns in Immune Effectors Cells-associated Neurotoxicity Syndrome (ICANS)Lay Language

Immune effectors cells-associated neurotoxicity syndrome (ICANS) is one of the most clearly defined acute toxicities after CAR-T cells infusion.

The investigators conducted a prospective cohort study of all patients who received CAR T cell infusions on the hematology department from Montpellier University Medical Center.

Each patient was assessed between the 6th and 8th day after infusion by a neurological clinical examination, an electroencephalogram, and a brain MRI.

The aim of the studies is to describe the EEG pattern associated with ICANS.

The investigators will conduct a prospective cohort study of all patients who received CAR T cell infusions in the hematology department from Montpellier University Medical Center. To be eligible for enrollment, patients should have to be 18 years of age or older. All the patients will have histologically confirmed: diffuse large B-cell lymphoma, B-cell acute lymphoblastic leukemia, follicular lymphoma, or mantle cell lymphoma.

Each patient will have a PET CT before infusion to determine metabolic response status according to the LUGANO grading classification. All patients will have preconditioning brain imaging by MRI.

Each patient will be assessed between the 6th and 8th day after infusion by a neurological clinical examination, an electroencephalogram, and a brain MRI.

Patients will be called back one month later to report any new neurological event and an EEG was performed if abnormalities were found on the first.

All neurological symptoms documented in daily progress notes will be catalogued. The investigators will use ASTCT ICANS Consensus Grading for Adults to evaluate neurotoxicity.

Eligibility Criteria:
Inclusion criteria:

* histologically confirmed: diffuse large B-cell lymphoma, B-cell acute lymphoblastic leukemia, follicular lymphoma, or mantle cell lymphoma.
* with infusion of CAR T-cells

Exclusion criteria:

- Age \< 18 years
Influence of a Residential Rehabilitation Program on Body Composition in Patients with Cystic Fibrosis

The aim is to evaluate the impact of a 3-week lasting residential rehabilitation program for patients with cystic fibrosis on their nutritional status measured as BMI and body composition and pulmonary function.

Cystic fibrosis Patients following a residential rehabilitation program consisting of dietary adaptation, physical therapy for airway drainage and supervised inhalation therapy and physical activity for at least 3 weeks are asked to participate. Weight, height, body composition and pulmonary function will be measured at start and end of the program. Dietary intake during the program is calculated based on a 2 day weighed intake diary and physical activity will be measured with the "SenseWear pro 3" armband.

Eligibility Criteria:
Inclusion Criteria:

* Cystic fibrosis
* stay at the rehabilitation center for at least 3 consecutive weeks

Exclusion Criteria:

* steroid use
* absence from the program for more than 2 consecutive days
Extension Study of Carvedilol RCT Study

Patients who have completed 2-years treatment in RCT Study of carvedilol will receive another 2-years extension therapy, aiming to investigate the long-term efficacy of carvedilol for the prevention of esophageal varices in treated HBV cirrhotic patients.

Carvedilol has been shown to be more potent in decreasing portal hypertension than propranolol. But the efficacy of carvedilol to prevent esophageal varices progression in nucleoside analogue (NUCs) treatment HBV related cirrhotic patients was unclear. Previous RCT study aimed to explore the effects of carvedilol for the prevention of the esophageal varices progression on HBV cirrhotic patients with anti-viral therapy has been conducted (NCT03736265). Patients who have completed 2-years treatment in RCT Study of carvedilol will receive another 2-years extension therapy, aiming to investigate the long-term efficacy of carvedilol for the prevention of esophageal varices in treated HBV cirrhotic patients. Patients were allocated according to the outcome of EDGs at 2-year during RCT study. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. A third EGDs will be performed at 4-year.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who completed the 2-year RCT study of carvedilol in HBV cirrhotic patients with anti-viral therapy;
* Subjects who are willing to participate the extension study.

Exclusion Criteria:

* Subjects who refused to receive 2-year EGD examination during the previous RCT study;
* Subjects who could not compliance with the protocol judged by investigators;
* Subjects who are not suitable for the study judged by investigators.
Neuromodulation Effect of Focused Ultrasound for Motor Recovery in Patients With Stroke

Transcranial focused ultrasound (tFUS) can be used as a non-invasive brain neuromodulation technique. Low-intensity focused ultrasound has been demonstrated to be safe and have neuromodulatory effects on the cerebral cortex in healthy human and animal experiments.This study aims to investigate the effect of tFUS on cortical excitability for motor recovery in patients with stroke.

The study is a pilot study for feasibility, which aims to recruit 20 patients with subacute (within 3 months) stroke and unilateral hemiparesis. tFUS stimulation will be delivered. The primary outcomes are defined as cortical excitability assessment in bilateral primary motor cortex, as well as safety analysis; the secondary outcome measures include the Fugl-Meyer Assessment, Medical Research Council score, National Institutes of Health Stroke Scale (NIHSS), Barthel Index, Modified Rankin Scale and functional brain activities.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stroke (including hemorrhagic or ischemic stroke) diagnosed by a board-certificated physician.
* Occurrence of stroke within three months.
* Upper limb muscle strength ≤ 4 points according to the Medical Research Council Manual Muscle Testing scale.
* No previous history of stroke, epilepsy, dementia, Parkinson's disease, or other neurodegenerative diseases.
* Patients could maintain sitting posture for more than 15 minutes on a chair.
* 18 years of age or older.

Exclusion Criteria:

* History of recurrent stroke, traumatic brain injuries, brain tumors, spinal cord injury, Parkinson's disease or other musculoskeletal system diseases that may affect evaluation and treatment.
* Contraindications to focused ultrasound, including pregnancy, cardiac pacemaker or implantable medical device, abnormal connective tissue diseases, coagulopathy (PLT\<100,000/μL, PT\>14 seconds, APTT\>36 seconds, INR\>1.3), implants near or in the brain, or those deemed Unsuitable for this treatment by the physician.
* Unable to cooperate with treatment or functional assessment due to impaired consciousness or aphasia; inability to informed consent.
* Patient with cranial bone factor causing the inability of tFUS penetration.
* Patient under anticoagulants with coagulopathy (PLT\<100,000/μL, PT\>14 seconds, APTT\>36 seconds, INR\>1.3)
* Patients who are not suitable for undergoing CT imaging examination;
* Major physical illnesses and neurological disorders (such as epilepsy, brain surgery, etc.)
* Patients with metallic implants in their bodies;
* Patients taking tricyclic antidepressants, analgesics, or using antiepileptic drugs
* Individuals experiencing sleep disorders during tFUS treatment;
* Individuals with history of alcoholism
* Patients with severe or uncontrollable intracranial pressure;
* Patients requiring anticoagulants;
* Any intracranial space-occupying lesions;
* Significant calcification of intracranial vessels based on pre-treatment CT imaging;
* Subjects with lesions/wounds on the scalp in the target region.
Recurrent Campylobacter Bacteraemia in Immunocompromised Patients

Some rare cases of recurrent Campylobacter bacteraemia (RCB) exist with relapses months to years after an effective treatment and a negativation of all bacterial samples.

As of today, only around 20 cases have been described in the international literature for the last 30 years. The cases are likely highly underreported.

No study describes those recurrent Campylobacter bacteraemias at the scale of a country.

The aim of this multicentre, nationwide, retrospective study is to describe their precise epidemiology in France for the last 25 years, the immune profile of the patients, the specificities of the bacteria involved, the treatments received and the evolution of these infections.

The perspective is to propose a standardization of the medical care of those patients mainly by describing the effective treatments and the explorations of the immune system which should be considered.


Eligibility Criteria:
Inclusion Criteria:

* 2 episodes or more of Campylobacter bacteraemia separated by at least 60 days
* AND immunodeficiency condition
* followed by a French hospital

Exclusion Criteria:

-Opposition of the patient
Interest of Instantaneous Fluctuations of Pupillary Diameter for Pain Evaluation in Intensive Care Sedated Patients.

New pain assessment parameter, called the Variation Coefficient of Pupillary Diameter (VCPD) described. This parameter allows evaluating the pain of patients during uterine contractions in obstetrical labor, and postoperatively in recovery room.

This parameter also allows evaluating the level of pain in Intensive Care Unit (ICU), in intubated or tracheotomized patients moderately sedated (Riker score 3 or 4).

This study propose to recalculate the Variation Coefficient of Pupillary Diameter (VCPD) from pupil recordings performed in the Intensive Care Unit (ICU) in 2015-2016 and kept in the patients' records. From there, the Variation Coefficient of Pupillary Diameter (VCPD) will compare to the Behavioral Pain Scale (BPS), considered the gold standard pain assessment

Eligibility Criteria:
Inclusion Criteria:

* hospitalized in the surgical Intensive Care Unit (ICU) of the University Hospital of Saint-Etienne between September 2015 and August 2016 for medical-surgical pathologies
* requiring orotracheal intubation or tracheostomy
* and presenting a Riker sedation score of 3 or 4.

Exclusion Criteria:

* cerebral palsy
* curarization
* paraplegia or tetraplegia
* intensive care neuromyopathy
* ocular pathology
* history of severe dysautonomic disease that could influence the evaluation of the Behavioral Pain Scale (BPS) or Variation Coefficient of Pupillary Diameter (VCPD) score
* receiving antiarrhythmic treatment that could make the interpretation of the results difficult
* on metoclopramide, droperidol, clonidine, or dexmedetomidine, which are known to alter the pupil dilation reflex.
Virtual Reality Video-based Learning

This teaching development aims to enhance the clinical reasoning and empathy of nursing students in nursing students in smoking cessation training. The evaluation aims to assess the feasibility and efficacy of virtual reality (VR) video-based learning for enhancing self-efficacy in delivering smoking cessation intervention. The proposed study is 2-arm, waitlist-control, pragmatic randomized controlled trial (RCT) (allocation ratio 1:1), by comparing the self-efficacy and performance of clinical reasoning between nursing students who are provided VR videos of a smoker's real-life scenario and reading materials (intervention group) and those who are only provided the same reading materials (control). Individual randomization will be used. All participants will be given a group assignment and expected to complete the assignment by the end of the tutorial. The group assignment and self-administered pre- and post-learning survey will be used for the teaching outcome evaluation.

The proposed study is 2-arm, waitlist-control, pragmatic randomized controlled trial (RCT) (allocation ratio 1:1), by comparing the self-efficacy and performance of clinical reasoning between nursing students who are provided VR videos of a smoker's real-life scenario and reading materials (intervention group) and those who are only provided the same reading materials (control). Individual randomization will be used. All participants will be given a group assignment and expected to complete the assignment by the end of the tutorial. The group assignment and self-administered pre- and post-learning survey will be used for the teaching outcome evaluation.

Eligibility Criteria:
Inclusion Criteria:

The study targets to recruit candidates of Master of Nursing who are taking the course "Tobacco Dependency Nursing Intervention and Management (NURS8205)" (n=65). All candidates are registered nurses.

Exclusion Criteria:

Students who cannot understand Cantonese will be excluded from the trial.
High Volume Injection in Mid Portion AChilles Tendinopathy

This prospective randomised clinical trial aims to evaluate the effectiveness of treatment for mid-portion Achilles tendinopathy in a real-world clinical setting, minimising the excessive control typically associated with explanatory studies. The primary focus is to assess the mechanical effects of high-volume image-guided injection in combination with rehabilitation exercises over three months. Additionally, the study will determine the overall clinical improvement in participants. The main questions it aims to answer are:

Is high-volume image-guided injection treatment superior to the usual care in treating mid-portion Achilles tendinopathy? Do mechanical and morphological properties of the tendon change after the treatment?

The objectives of this trial are to

* Evaluate the effectiveness of high-volume image-guided injection combined with rehabilitation exercises in improving symptoms and functionality in patients with mid-portion Achilles tendinopathy.
* Measure changes in the mechanical properties of the Achilles tendon, including dynamic stiffness, as well as morphological characteristics such as thickness, cross-sectional area, and neovascularisation following treatment.
* Assess patient-reported outcomes related to pain, disability and function using validated questionnaires
* Explore participants' experiences and perceptions regarding their symptoms and the trial itself.

Eligibility Criteria:
Inclusion Criteria:

* Participants with mid-portion Achilles tendon pain in one or both legs. In bilateral symptoms, the most symptomatic leg will be considered for assessing the intervention or standard progressive rehabilitation exercise programme.
* Participants with chronic Achilles tendinopathy for more than three months who had previously undergone physiotherapy and exercise rehabilitation but experienced no improvement or continued to suffer from severe pain.
* Having one or more ultrasonography characteristics of mid-portion tendinopathy including thickened tendon, neovascularisation, hypoechogenic areas or loss of fibrillar homogeneity.

Exclusion Criteria:

* History of previous Achilles tendon rupture or surgically repaired tendons.
* Presentation of insertional Achilles tendinopathy or concurrent pain at both the insertional and mid-portion of the Achilles tendon at the start of the study.
* Presence of neurological or metabolic conditions known to affect tendon health
Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers

This is a randomized, double-blind, placebo-controlled, single ascending oral dose and food effect study conducted at one study center in the United States. Safety and tolerability will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of SXC-2023.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult male or females (women of non child bearing potential), 18-55 years of age (inclusive).
2. Medically healthy with no clinically significant screening results.
3. Non-vasectomized male subjects must agree to use birth control or abstain from sexual intercourse during and until 90 days beyond the last dose of study drug/placebo.
4. Continuous non-smoker, at least 3 months prior to first dose and throughout the study.
5. Understands the study procedures in the informed consent form, and be willing and able to comply with the protocol

Exclusion Criteria:

1. Subject is mentally or legally incapacitated.
2. History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subjects by their participation in the study.
3. History or presence of alcoholism or drug abuse within the past 2 years
4. Female subject of childbearing potential.
5. Blood donation or significant blood loss within 56 days prior to first dose.
6. Plasma donation within 7 days prior to first dose.
7. Participation in another clinical trial within 30 days prior to first dose.
Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia

This research is being done to compare the effect of tadalafil with placebo (an inactive substance that looks like the study drug, but should have no effect) on the frequency of recurrent priapism (prolonged erection, unassociated with sexual interest or desire) and the nature of sexual experiences in male patients with sickle cell disease.

This study will investigate phosphodiesterase 5 (PDE 5) inhibitor therapy as a potential treatment for recurrent ischemic priapism. Enrolled participants will be randomized to receive oral 10 mg tadalafil tablets 3 times a week or receive matching placebo. Patients will be instructed to use the medication in the morning a few hours after awakening from night time sleep, and they will be instructed against engaging in any form of sexual activity or excitement within 8 hours of dosing. Treatment duration will be 2 months for each participant. After the 2 month period, participants on tadalafil and placebo will be offered tadalafil (same dosing regimen) for an additional 2 months.

The study duration will be 4 months.

Tests and procedures will include: consent; medical history; physical examination; clinical laboratory tests; completion of questionnaires; and medication dispensation.

Eligibility Criteria:
Inclusion Criteria:

* All men (18 years of age and older) with actively recurrent ischemic priapism, defined as multiple, self-limited erectile events (characteristically less than 3 hours in duration) occurring repeatedly at least twice a week in the absence of sexual interest or desire may be considered for enrollment
* Able to swallow whole tablets equivalent to capsule size 0
* Available for protocol-specified visits and procedures

Exclusion Criteria:

* History of refractory-type priapism
* History of drug or alcohol abuse
* Currently smokes or has a 20 pack-year history of cigarette smoking
* Take any medications called "nitrates"
* History of acute or chronic depression
* History of heart problems such as angina, heart failure, irregular heartbeats or myocardial infarction
* History of low blood pressure or high blood pressure that is not controlled
* History of diabetes, liver problems, or kidney problems
* A glomerular filtration rate of \<50ml/min.
* History of retinitis pigmentosa or severe vision loss, including a condition called NAION
* History of stomach ulcers
* History of HIV, multiple myeloma, or leukemia
* History of Peyronie's disease
* History of spinal trauma or surgery to the brain or spinal cord
* Any contraindications to Cialis use
* Currently participating in another clinical investigation
Premature Luteinization Prevention by GnRH Antagonist in Patients Undergoing IUI

Premature luteinization in patients undergoing IUI can occur in up to 24% of cycles. These patients, according to recent data, have a lower pregnancy rate than controls. The possibility to avoid premature luteinization with GnRH antagonist may restore the chances of achieving a pregnancy in these women.

The purpose of this study was to investigate whether a subset of patients benefits from GnRHa administration during IUI. PL was tested for in patients who were undergoing artificial insemination procedures, and the effect of GnRHa on PR in patients who

Eligibility Criteria:
Inclusion Criteria:

* previous failed IUI cycle with premature luteinization

Exclusion Criteria:

* 39 years or older
* not eligible for IUI (patent tubes, \> 3 million capacitated spermatozoa)
* 4 previous IUI cycles