cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Cytokine Adsorption and Plasma Exchange in Patients With HBV-ACLF and Sepsis

This study aims to evaluate the efficacy and safety of the double plasma cytokine adsorption system with sequential low-dose plasma exchange (DPCAS+LPE) in patients with hepatitis B-related acute-on-chronic liver failure (HBV-ACLF) complicated by sepsis. The focus is on assessing the impact of the cytokine adsorption column(CA280,Jafron Biomedical Co., Ltd., Zhuhai, China) on survival rates, inflammation markers, and organ function to determine its potential value in clinical practice.

The primary research questions are: (1) Does DPCAS+LPE artificial liver therapy improve the 4-week mortality rate in HBV-ACLF patients with sepsis? (2) Does it improve the 12-week mortality rate in these patients? Additionally, the study examines the effects of this therapy on APACHE II scores, SOFA scores, vasoactive-inotropic score, MELD scores, and COSSH-ACLF II scores, as well as the cytokine adsorption efficiency of the CA280.

Patients were randomly assigned to either the DPCAS+LPE group or the plasma exchange(PE) group. All patients received artificial liver therapy every other day, for a total of two sessions. Follow-up assessments were conducted before and after each therapy session, as well as at 1, 2, 3, 4, and 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 65 years.
2. Total bilirubin (TBIL) \> 12 mg/dL, 3\>INR ≥ 1.5.
3. Meets the diagnostic criteria for sepsis 3.0: confirmed or suspected infection with an increase in SOFA score by ≥ 2 points.
4. High inflammatory state: IL-6 \> 100 pg/ml.
5. Persistent HBsAg or HBV DNA positivity for more than 6 months.
6. Onset of sepsis within the past 72 hours.

Exclusion Criteria:

1. Presence of other causes of chronic liver disease, such as infection with other hepatotropic viruses, alcoholic liver disease, autoimmune liver disease, or genetic metabolic liver disease.
2. Patients with liver malignancies or other concurrent cancers.
3. Pregnancy or lactation.
4. Patients with HIV infection or other immunodeficiency diseases.
5. Patients with autoimmune diseases, recent cardiovascular events leading to unstable infarction, or a history of organ transplantation.
6. End-stage organ failure:

   End-stage chronic obstructive pulmonary disease, end-stage pulmonary heart disease, brain death, or persistent vegetative state, Grade IV hepatic encephalopathy.

   End-stage renal disease or acute renal failure requiring CRRT. Inability to maintain a mean arterial pressure above 65 mmHg despite adequate fluid resuscitation, vasopressors, and steroid therapy.
7. Platelet count \< 50×10⁹/L, severe coagulopathy, or active bleeding.
8. Allergic reactions to extracorporeal circulation, hemoperfusion substances, or history of severe allergies.
9. Inability to comply with study protocols or refusal to sign the informed consent form.
10. Inability to attend regular follow-up visits according to the study schedule.
11. Any other conditions that, in the investigator's judgment, make the patient unsuitable for inclusion in the study.
Parent Predicting of Their Child Behavior During Their First Dental Examination

The aim of this study is to assess the parental expectation for their child behavior in a group of children with primary dentition during their first dental examination

Assessment of children based on their behavior is one of the most important skills for a pediatric dentist. The major aspect of child management in the dental care is managing dental anxiety and fear as it is considered to be the main barrier for successful completion of dental treatment.

Dental anxiety is a common problem which develops mostly in childhood and adolescence. It can have major implications for the child, dental team, and dental services. Providing treatment for the child with dental anxiety can be time-consuming, costly, and demanding for the clinician.

Previous studies have shown that a majority of children with dental anxiety present behavior management problems (BMP) in dental treatment situations. Evaluating a child's level of anxiety before pediatric treatment is the key, since this anxiety is closely related to their behavior during dental visits. Therefore, predicting the behavior is a basic requirement to reduce child's negative attitude during treatment.

Many behavior rating scales are available to assess and evaluate the behavior of a child on each dental visit. Frankl et al classified child's behavior into four groups according to the child's attitude and cooperation or lack of cooperation during dental treatment. This classification is known as Frankl behavior rating scale, which is one of the most reliable tools developed for behavior rating of children in dental sittings.

Eligibility Criteria:
Inclusion Criteria:

1. Child with Primary dentition
2. First dental visit.
3. Parents of children who agree to fill the questionnaire.

Exclusion Criteria:

1. Child with dental emergency
2. Child with psychological problem
3. Child with chronic illness
Risk Factors for Staphylococcus Aureus Surgical Site Infections in Orthopedic and Trauma Surgery

The most commonly identified organism for Surgical Site Infection (SSI) in orthopedic surgery is Staphylococcus aureus but risk factors for mono microbial S.aureus SSI are not well-known. The aim of this study was to evaluated the incidence rate of S. aureus SSI over the years and risk factors of these infections in a french University Hospital.

Surgical site infections (SSI) in orthopedic surgery are responsible for reduced quality of life, increased length of hospital stay and costs. The most commonly identified organism is Staphylococcus aureus but risk factors for mono microbial S.aureus SSI are not well-known.The aim of this study was to evaluate the incidence rate trend of S. aureus SSI over the years and risk factors of theses infections in a french University Hospital.

The knowledge obtained by this study will enable identification of the surgical patients most at risk of developping S. aureus SSI, and who would probably benefit most from new interventions given prophylactically and specifically to prevent S. aureus infections.

Eligibility Criteria:
Inclusion Criteria:

* orthopedic or traumatology surgeries performed in Grenoble University Hospital,
* from january 1st 2012 to april 30th 2015,
* the subject is undergoing one of the following surgical procedures : knee and hip arthroplasties, osteosynthesis of proximal femur and other osteosynthesis except skull and spine.
* the subject is 16 years of age or older

Exclusion Criteria:

* non orthopedic or trauma surgery performed in Grenoble University Hospital,
* spine surgeries,
* surgeries of the hand, scaphoid and carpal bones.
Ruxolitinib Managed Access Program (MAP) for Patients Diagnosed With Severe/Very Severe COVID-19 Illness

The purpose of this Cohort Treatment Plan is to allow access to ruxolitinib for eligible patients diagnosed with severe/very severe COVID-19 illness. The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations.

The requesting Treating Physician submitted a request for access to drug (often referred to as Compassionate Use) to Novartis which was reviewed and approved by the medical team experienced with the drug and indication.

Please refer to the latest Investigator's Brochure (IB) or approved label for overview of ruxolitinib including: non-clinical and clinical experience, risk and benefits. Novartis will continue to provide any new safety information to the Treating Physician as they emerge.


Eligibility Criteria:
Inclusion Criteria:

Patients eligible for inclusion in this Treatment Plan have to meet all of the following criteria:

Written patient informed consent or assent must be obtained prior to start of treatment.

* Patients aged ≥ 6 years
* Patients clinically diagnosed with SARS-CoV-2 infection, either through positive serum antibodies (IgM or IgG); or by PCR; or by other approved diagnostic methodology. Patients with presumptive diagnosis of COVID-19 (other respiratory causes ruled out and SARS-CoV-2 test pending) may be included.
* Adult and adolescent patients (≥12years), who meet one of the below criteria

  * Respiratory frequency ≥ 30/min
  * Oxygen saturation ≤ 93% on room air (FiO2=0.21)
  * Arterial oxygen partial pressure (PaO2)/ fraction of inspired oxygen (FiO2) \<300mmHg(1mmHg=0.133kPa) (corrective formulation should be used for higher altitude regions (over 1000m).

AND

-- Patients with lung imaging showing pulmonary infiltrates (chest X-ray or CT scan)

Pediatric patients (≥6-\<12 years) who meet one of the below criteria (where appropriate):

* Shortness of breath
* Oxygen saturation \<92% on room air (Fi)2=0.21)
* Labored breathing (e.g. wheezing, flaring of nostrils, three concave sign), cyanosis, intermittent apnea.
* Lethargy or convulsions
* Refusal to eat or difficulty with feeding; signs of dehydration

Exclusion Criteria:

* Patients eligible for this Treatment Plan must not meet any of the following criteria:
* History of hypersensitivity to any drugs or metabolites of similar chemical classes as ruxolitinib
* Presence of severely impaired renal function defined by serum creatinine \> 2 mg/dL (\>176.8 μmol/L), or have estimated creatinine clearance \< 30 ml/min measured or calculated by Cockroft Gault equation or calculated by the updated bedside Schwartz equation.
* Pregnant or nursing (lactating) women.
* Patients who are NOT able to understand and to comply with treatment instructions and requirements unless health care proxy is able to provide consent.
3D Shoulder Kinematics During Throwing-related Movement Patterns Tasks in Upper Extremity Low-to-moderate/Moderate-to-high Loading Conditions

The main purpose of this study is to characterize and compare the 3D shoulder kinematics bilaterally while performing functional movement patterns tests that hypothetically replicate the 5 main phases of the throwing cycle. The tests are based on diagonal D2 for flexion (early and late cocking of the arm) and D2 for extension (acceleration, deceleration and follow-through of the arm) of the upper extremity of proprioceptive neuromuscular facilitation techniques.

The 3D shoulder kinematics (thorax, scapula and humerus) will be collected in different groups of subjects with specific characteristics. To load the upper extremity during PNF D2 for flexion and extension directions, elastic tubing (Thera-Band) will be used as resistance. Selection of the two resistances will be according to a self-perceived ability of the subjects to consistently move a maximal amount of resistance (color) during PNF D2 flexion and extension tests for 15s and 30s, respectively. Each subject will be permitted to sample various resistances in order to assist in selecting the most appropriate load, with no more than three practice repetitions permitted per each resistance sampled.

To perform the tests, subjects will be sited in a standard chair without armrests, with their feet and lower legs placed on another standard chair, positioned just in front of their chair and the non-testing arm placed across the thoracic wall, to minimize the participation of the legs and trunk to upper extremity performance during testing. Elastic tubing will be anchored to a stable base to perform the diagonals (Thera-Band door anchor accessory or the opposite foot). Five repetitions of each test on both sides will be performed, in two different moments (5-10 minutes apart). A rate of 2 seconds per repetition will be employed during recordings using a metronome. A rest period will be given between trials to avoid fatigue. To perform the tests, subjects will begin/end with their hand on the contralateral hip and end/begin at head height and shoulder width. A marker will be placed in the latter position to standardize the start and end of hand position. The order of the tests (PNF D2 flexion and extension) and side (symptomatic/dominant and asymptomatic/non-dominant) will be randomized.

Eligibility Criteria:
Inclusion Criteria:

* subjects who can perform at least 150 degrees of arm elevation

Exclusion Criteria:

* subjects rating pain ≥8/10
* score 5 on any of the items of the Disabilities of Arm, Shoulder and Hand (DASH)
* pain elicited by provocation maneuvers of the neighboring regions (e.g., cervical spine).
Study in Allergic Adults to Support the Development of Immunological Assays

The purpose of this study is to develop and characterize immunological assays on blood samples.

This is a clinical study in which there is no vaccine administered. It is designed for research purposes such as developing immunological assays.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject.
* Healthy subjects (except the condition studied in the ALLERGY group).
* A male or female between, and including 18 and 45 years of age at the time of study start.
* Subject presenting moderate to severe clinical symptoms of allergy within the week before enrolment (only for ALLERGY group).
* Subjects suffering from seasonal allergy to birch pollen previously documented by a medical history (only for ALLERGY group).
* A positive skin prick test response realised and/or a positive test for specific IgE against birch within the last 5 years (only for ALLERGY group).

Exclusion Criteria:

* Any known or clinical signs of anaemia or any condition that would preclude the drawing of blood as described in the protocol.
* Receipt of blood products 120 days prior to study visit.
* Receipt of immunoglobulin 120 days prior to study visit.
* Use of any investigational or non-registered product within 30 days preceding the study visit.
* Concurrently participating in another clinical study, at the time of the study visit, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
* Any confirmed or suspected autoimmune or inflammatory disorders.
* Administration of systemic or inhaled anti-inflammatory medications and, in particular, inhaled corticoid-steroids and cromoglycates within 30 days preceding the study visit. Purely local medications such as intranasal steroids or systemic symptomatic medications such as antihistamines and beta agonists are allowed.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the study visit.
* Pregnant or lactating female.
* Any past or current birch-specific immunotherapy (only for ALLERGY group).
* Any allergic disease as established by medical history before study start (only for CONTROL group).
* Family history of allergic diseases in the first degree family members (only for CONTROL group).
Prediction of Cognitive Properties of New Drug Candidates for Neurodegenerative Diseases in Early Clinical Development

The early assessment of new drugs for Alzheimer's disease remains difficult because of the lack of predictive end-point. The use of a battery including different parameters could improve this early development of new drugs. Nevertheless, the interest of such a battery should previously be validated with the yet marketed AD drugs

The aim of the present study is to test the effect of a 15-day treatment with donepezil on a mixed battery associating cognitive assessment, imaging and neurophysiological tests in healthy volunteers.

This multicenter, randomized, placebo-controlled, cross-over study is double-blind controlled and is conducted in 3 centers located in France (Lille, Marseille and Toulouse).

18-30 years old, healthy volunteers, without any neurological or psychiatric impairment, will complete 2 test sessions in a randomized order: one with a 15-day treatment with donepezil, the other with placebo, and will be submitted to a mixed battery during the 14th and 15th day of the treatment. The primary outcome of the study will be based on cognitive assessment, imaging parameters and neurophysiological parameters.

Eligibility Criteria:
Inclusion Criteria:

* 18-30 year old male non-smoker subjects
* Subject without cognitive impairment or cognitive complaint (Moca\>26, Mac Nair scale\<15)
* Subject without history of brain disease (severe brain trauma, stroke, cerebral tumor,...)
* Subject without major medical or surgical history
* Subject without current chronic disease
* Subject without current cerebral disease
* Subject without vascular or metabolic risk factor
* Subject without history or current mental disease or addiction (MINI)
* Subject without lesion on MRI
* Subject without abnormal electrical activities on EEG
* Subject without use of chronic treatment or psychotropic drugs or substances
* French speaker subject and able to understand the test instructions

Exclusion Criteria:

* Subject with age \< 18 years or \> 30 years
* Subject with dementia or cognitive decline identified by Moca \< 26
* Subject with history of brain disease (brain trauma, stroke, cerebral tumor,...)
* Subject with major medical or surgical history
* Subject with current chronic disease
* Subject with current cerebral disease
* Subject with vascular or metabolic risk factor
* Subject with history or current mental disease or addiction
* Subject with family history of young-onset dementia
* Subject with family history of chronic or severe neurological or mental disease (first degree relatives)
* Subject with lesion on MRI
* Subject with abnormal electrical activities on EEG
* Subject receiving a chronic treatment
* Subject using chronically or acutely psychotropic drugs or substances
* Subject with claustrophobia or contra-indication to MRI
* Subject unable to understand the test instructions
Does the National Health Insurance Card Allow us to Predict Antibiotic Resistance?

The objective is to determine if data from the National Insurance Health card (giving antibiotics and hospitalizations in the past 18 months) allow to predict the individual risk of antibiotic resistance and to identify population groups for which probabilistic antibiotics regimen of urinary tract infection could be simplified


Eligibility Criteria:
Inclusion Criteria:

* national health insurance card available
* community acquired urinary tract infection

Exclusion Criteria:

* incapacity to accept an inform consent
* hospitalized acquired urinary tract infection
* national health insurance card non available
Impact of Thermocoagulation During Invasive EEG Monitoring in Children With Focal Drug-resistant Epilepsies

When focal epilepsies become drug-resistant, it could be eligible for cortical surgical resection. Therefore, an invasive EEG monitoring with depth electrodes is often needed during presurgical evaluation. Some of these children can have access to thermocoagulation inside the ictal onset zone, at the end of the monitoring and before to remove the electrodes. These thermocoagulations can disorganize the epileptogenic network thanks to millimetric cortical lesions around the electrodes. The aim is to stop or at least, to reduce the seizure frequency for few weeks or months. This could be a benefit for the child, and also a confirmation of the ictal onset zone and guide the surgeon. This technique is currently used in adult population for years, but remains very rare in children.


Eligibility Criteria:
Inclusion Criteria:

* age 18 month to 17 years old
* focal drug-resistant epilepsy
* small size lesion (1 or 2 gyri) or cryptogenic epilepsy
* indication for EEG monitoring with depth electrodes during presurgical evaluation

Exclusion Criteria:

* formal contraindication to surgery or anaesthesia
* functional area or potentially large epileptic area
* refusal to participate in the study
* no health insurance coverage
Multimodal Instrumented Assessment of Post-stroke Elbow

The proposed clinical trial will employ the NEUROExos Elbow Module (NEEM), an active robotic exoskeleton, for the passive mobilization and active training of elbow flexion and extension in 60 sub-acute and chronic stroke patients with motor impairments (hemiparesis and/or spasticity) of the right arm. The study protocol is a randomized controlled trial consisting of a 4-week functional rehabilitation program, with both clinical and robotically instrumented assessments to be conducted at baseline and post-treatment.

The reliable assessment, attribution, and alleviation of upper-limb joint stiffness are essential clinical objectives in the early rehabilitation from stroke and other neurological disorders, to prevent the progression of neuromuscular pathology and enable proactive physiotherapy towards functional recovery. However, the current clinical evaluation and treatment of this stiffness (and underlying muscle spasticity) are severely limited by their dependence on subjective evaluation and manual limb mobilization, thus rendering the evaluation imprecise and the treatment insufficiently tailored to the specific pathologies and residual capabilities of individual patients. To address these needs, the proposed clinical trial will employ the NEUROExos Elbow Module (NEEM), an active robotic exoskeleton, for the passive mobilization and active training of elbow flexion and extension in stroke patients with motor impairments (hemiparesis and/or spasticity) of the right arm. The study protocol provide a functional rehabilitation program, with both clinical and robotically instrumented assessments to be conducted at baseline and post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Upper limb spasticity due to neurological impairment;
* Cognitive abilities sufficient for understanding instructions;
* Absence of severe pain assessed as Visual Analogic Score (VAS) \< 4 (range 0-10).

Exclusion Criteria:

* Unstable general clinical conditions;
* Inability to keep sitting posture;
* Tendon retractions limiting upper limb joints range of motion.
The Effect of Anti-calcitonin Gene-related Peptide (CGRP) Receptor Antibodies on the Headache Inducing Properties of CGRP and Cilostazol in Migraine Patients

A randomized, double-blind, placebo-controlled, parallel study to investigate the effect of erenumab in calcitonin-gene related peptide and cilostazol experimental models of migraine in humans. Followed by a 6-month open-label extension.


Eligibility Criteria:
Inclusion Criteria:

* Patients with migraine with or without aura according to the International Classification of Headache Disorders with a frequency of ≥4 migraine days per month
* 50-100 kg weight
* Participants of childbearing potential must use safe contraception (birth control) or be sexually abstinent

Exclusion Criteria:

* Any other primary headache disorder according to the International Classification of Headache Disorders except for tension-type headache
* Any secondary headache disorder according to the International Classification of Headache Disorders
* Migraine attack during the preceding 48 hours on provocation day
* Headache during the preceding 24 hours on provocation day
* Treatment with monoclonal antibodies or participation in clinical trials with monoclonal antibodies during the preceding year
* Daily consumption of any other drug/medication than oral contraception (birth control)
* Consumption of any other drug/medication later than four times the plasma half-time of the drug on provocation day except for oral contraception
* Pregnant or active breastfeeding participants
* Any cardiovascular diseases including cerebrovascular disorders
* Information in patient history or during physical examination indicating psychiatric disorders or substance abuse
* Information in patient history or during physical examination that the screening physician deems relevant for participation in the study