cyrilzakka/clinical-trials huggingface dataset:
Early Pharmacological and Immune Monitoring After Conversion to Belatacept in Renal Transplant Patients

Single-center, prospective, translational, clinical-biological, multidisciplinary study

All patients starting belatacept will be informed about non-interventional study and will be included unless they do not accept (non-opposition, consent is not required). Patients will be included and followed up during the 6 first months, i.e. 9 infusions. Blood samples (3 heparinized tubes of 7ml + 1 dry tube without separator gel of 5ml, i.e. 26ml maximum per sample) and urine samples will be harvested before each perfusions and in case of rejection. Clinical and biological data will be collected in an electronic CRF.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Renal transplant patient
* Patient converted from an anticalcineurin to belatacept

Exclusion Criteria:

* Opposition to data processing
* Hemoglobin \< 9g/dL
* Patient under judicial protection
* Pregnant or breastfeeding woman
ANGH Prospective Cohort of Mild and Severe Acute Biliary Pancreatitis

The main objective of this work is to evaluate the recurrence of biliary episodes before cholecystectomy (hepatic colic, lithiasic migration, cholangitis, cholecystitis, pancreatitis, necrosis infections) in patients with acute biliary pancreatitis of any severity depending on the type of nutrition (oral, enteral or parenteral).

Acute pancreatitis (AP) is one of the frequent causes of hospitalization in gastroenterology with an annual incidence of 13-45 cases per 100,000 patients. If we refer to the data in the white paper, hospitalizations for abdominal emergencies, such as PA, take place in at least 60% of cases in General Hospital Centers (CHG). Among these AP, approximately 40% of AP are secondary to a biliary lithiasis pathology. The main modalities of the initial management of AP have been the subject of several national and international recommendations and consensuses. Although it is well accepted that early refeeding during the first 48 hours reduces the appearance of a systemic inflammatory response syndrome (SIRS) or a collection infection, the feeding methods in the event of pancreatitis Acute biliary (ABP) during the acute phase using the oral route if it is tolerated or the enteral route by nasogastric tube before cholecystectomy remains debated.

Thus, in case of delayed cholecystectomy after AP, there is no consensus on the feeding methods after the acute phase (oral or enteral) until cholecystectomy nor on the benefit of a prophylactic endoscopic sphincterotomy in the absence of cholangitis.

Eligibility Criteria:
Inclusion Criteria:

* Adult over 18 years old
* Affiliated to a social security scheme.
* Patients with acute biliary pancreatitis

Exclusion Criteria:

* Patients with chronic pancreatitis
* Patients with a previous cholecystectomy
* Patients under guardianship, curatorship or legal protection
End-range Mobilization on Time Curve of Pressure Pain Threshold

Pain in knee osteoarthritis (OA) represents increased pain intensity due to peripheral and central sensitivity. Pressure pain threshold (PPT) is a widely applied technique for measuring the magnitude of peripheral and central sensitivity in knee OA. Despite several manual therapy techniques has been proven to increase PPT in knee OA, the effect of end-range mobilization on the time curve of PPT has not been evaluated so far in knee OA. The aim of this study was to investigate the effect of end-range mobilization on the time curve of PPT and some function-related measures in knee OA.

Knee osteoarthritis (OA) is the most common form of arthritis leading to a major disability worldwide. Although many mechanisms may contribute to knee pain severity, the patient-reported hyperalgesia can be attributed to peripheral and central sensitivity in knee OA. Amongst quantitative sensory testing methods, pressure pain threshold (PPT) measurement is a simple and commonly applied method for measuring somatosensory function in musculoskeletal disorders, just as in knee OA. Many trials have presented lower PPT in knee OA compared to healthy controls underlining the presence of peripheral and central sensitivity.

The different joint-based mobilization techniques may not only alleviate pain, but also increase pain tolerance to the locally applied mechanical pressure. Positive results of these techniques on increase of PPT has been reported in knee OA; however, the time curve of PPT has not evaluated so far in knee OA. Therefore, the aim of this study was to investigate the effect of end-range mobilization on the time curve of PPT and some function-related measures in knee OA.

Eligibility Criteria:
Inclusion Criteria:

* the clinical classification criteria of knee OA according to the American College of Rheumatology
* Categorization of patients as End Of Range Problem based on manual therapy
* unilateral/bilateral symptomatic tibiofemoral knee osteoarthritis with radiographic evidence of Kellgren-Lawrence scale between 1 and 3
* pain during weight-bearing activities at least within 6 months
* sufficient mental status

Exclusion Criteria:

* acute inflammation of the knee
* class II. obesity (body mass index, BMI\>35kg/m2)
* severe degenerative lumbar spine disease (e.g. spondylolisthesis)
* systemic inflammatory arthritic or neurological condition
* physiotherapy/balneotherapy attendance or manual therapy within 3 months
* intraarticular injections in the prior 12 months
* use of walking aids
* contraindication for manual therapy
* complex regional pain syndrome
* cognitive impairment
The Study on the Efficacy of tDCS Stimulation of the Cerebellum Combined With XingNaoJing Injection in Patients With Consciousness Disorders After Cranial Injury

The purpose of this study is to investigate the effect of tDCS stimulation of cerebellum combined with Xingnaojing on patients with disturbance of consciousness after craniocerebral injury, and to clarify the relationship between the following two points: (1) to clarify whether MMN, P300, fNIRS, BAEP, SEP can be used as objective indicators to distinguish VS from MCS. (2) To clarify the changes of consciousness level and brain function in DoC patients with craniocerebral injury treated with tDCS stimulation of cerebellum combined with Xingnaojing.


Eligibility Criteria:
Inclusion Criteria:

1. aged 18-80 years;
2. All patients met the diagnostic criteria of DoC;
3. more than 1 month after the initial head injury;
4. stable consciousness for at least 2 weeks before admission (no change in CRS-R total score);
5. no skull defect or large area of skull repair;
6. The legal representative authorized by the patient approved the experimental protocol and signed the informed consent form.

Exclusion Criteria:

1. supratentorial abnormalities on computed tomography (CT) or magnetic resonance imaging (MRI) involving more than one third of the middle cerebral artery territory;
2. a life expectancy of less than 3 months or a follow-up of less than 3 months;
3. retention of intracranial metal objects, cranial debridement, or presence of cranial defects and any clinically significant or unstable medical diseases;
4. EEG recording with significant muscle artifacts and inhibitory bursts;
5. nonconvulsive status epilepticus; Periodic or burst rhythms evoked by stimulation;
6. disturbance of consciousness due to surgical injury or tumor.
Advanced EEG Technology in Childhood Epilepsy

A lot of effort has already been put into the development of smaller, wearable and more user-friendly devices to monitor seizures in patients with epilepsy.

The investigators hypothesize that a wearable EEG ( in combination with additional non-EEG biosignals (motion, ECG, EMG, respiration, temperature,...) derived from Byteflies Sensor Dot and new medical patches (Plug 'n Patch system), will be able to objectively detect epileptic seizures and monitor sleep in the hospital and home environment for specific types of childhood epilepsy.

The accuracy of seizure detection and sleep monitoring by the wearable miniature EEG device in combination with other (autonomic) biosignals (full PnP system) will be compared with the golden standard video-EEG and seizure and sleep diaries filled-out by the participants.

The objective of the study will be the following:

1. Multimodal seizure detection Evaluation of data quality and seizure annotation accuracy. Comparison of data derived from the multimodal wearable device (Sensor dot in combination with Plug and Patch system) versus video EEG and seizure diary in childhood epilepsy syndromes with

   * Tonic seizures
   * Atonic seizures
   * Myoclonic seizures During wakefulness and during sleep
2. Sleep monitoring Assessment of sleep data quality, latency, sleep fragmentation and time spent in different sleep stages in different childhood epilepsy syndromes. Investigation of the influence of occuring seizures on sleep architecture.

Comparison of data wearable device (Byteflies Sensor Dot in combination with Plug and Patch system) versus video-EEG and sleep diary in childhood epilepsy syndromes.

Eligibility Criteria:
Inclusion Criteria:

* Childhood epilepsy with tonic, atonic or myoclonic seizures
* Parental informed consent and assent of the child if applicable
* Parent or caregiver can keep a seizure and sleep diary reliably.

Exclusion criteria

* Inability to provide written informed consent by parent or caregiver.
* Known allergy to electrodes or medical adhesives used as part of the study protocol.
* Having an implanted device, such as (but not limited to) a pacemaker, ICD, VNS because Sensor Dot contains magnets that could interfere with the operation of these devices.
* Any other condition or finding that would compromise the safety of the participant or the quality of the study data, or otherwise interfere with achieving the study objectives, as determined by the investigator or research coordinator.
Implementation of a Registry for Patients with Stroke

Pathology registers are scientific research tools for the development of epidemiological and clinical studies and health planning, which allows access to useful elements for planning adequate health services. The Registry collects demographic, clinical and functional data of stroke patients and arises from the need to order and update this information for epidemiological and research purposes, for a better knowledge of this pathology from a rehabilitation point of view and to accelerate the development of new treatments.

The Italian Society of Physical and Rehabilitation Medicine has published a minimal assessment protocol for stroke patients1 (PMIC2020) to share the evaluation of stroke rehabilitation needs and outcomes at any time of the rehabilitation pathway, as grounds for a National Stroke Rehabilitation Registry (SRR).

The STRATEGY multicentric study aims to verify the feasibility of implementing a PMIC2020-based SRR in a routine clinical setting, and develop data-driven prognosis prediction models.

Demographic, functional and clinical variables will be collected at the admission and the discharge of the patient; in addition, two telephone follow-ups (three months and six months from the event) will be carried out

The study will involve several rehabilitation centers of the Don Gnocchi Foundation, Italy

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (over 18 years of age) with ischemic or haemorrhagic stroke, first event or with relapse, time to onset of stroke less than 6 months, signature of informed consent by the patient or family member.

Exclusion Criteria:

* Patients from Severe Acquired Brain Injuries units and / or with diseases that threaten the patient's life
Lipid Metabolism in COVID-19 Severe Pneumonia Compared With Severe Pneumonia Caused by Other Pathogen

SARS-COV 2 infection might be responsible for sever pneumonia. Obesity seems to be a risk factor for severe SARS-COV 2 pneumonia. Lipid metabolism alteration are described with both obesity and sepsis. The aim of the present study was to describe association between lipid metabolism, obesity, sepsis inflammation and clinical outcome in COVID-19 patient with severe pneumonia compared with severe pneumonia caused by other pathogenes.


Eligibility Criteria:
Inclusion Criteria:

* 2 of the following criteria: Cough/ Dyspnea/ Spitting/ Thoracic pain/ Hyperthermia (\>=38 °C) Hypothermia (\< 35°C) AND new radiologic pulmonary infiltrate
* At admission or within 48 hours following hospital admission
* With 2 qSOFA criteria: MAP =\< 100 mmHg, Respiratory Rate \>= 22, Glasgow score \< 15 OR on mechanical ventilation OR under vasopressor
* Age \> 18
* affiliated to social security

Exclusion Criteria:

* Pregnancy
* immunodepression
* Pathology known to cause severe lymphopenia
* hospitalisation within 3 month before inclusion AND sepsis
Descriptive Observational Study of Patient-performed Pre-oxygenation

The aim of this research would be to determine the efficacy and effects of preoxygenation when performed by the patient (mask held by the patient).

This is the concept of "self-preoxygenation".

Pre-oxygenation is a fundamental element of the induction sequence in anesthesia, described and recommended since 1955. Numerous studies have examined and compared the various techniques for implementing this procedure in terms of duration, objectives, equipment, patient characteristics and conditions. None of them specifies who should hold the mask when carrying out this recommendation. In everyday practice, patients are often asked to hold the mask themselves. A preliminary survey showed that 86% of patients are offered this option. The professionals questioned cited relational reasons (83%) above all, but also organizational reasons (43%).

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing scheduled surgery with general anesthesia
* Patient classified ASA I or II
* Patient understanding and speaking French
* Patient informed of the study and not opposed to it
* Decision to have preoxygenation carried out by the patient.

Exclusion Criteria:

* Patients with grade II or III obesity (BMI\>35)
* Patient with at least one respiratory comorbidity
* Smoking patient
* Pregnant patients
* Patient with an allergy to one of the mask's components
* Patient with cognitive impairment or known comprehension difficulties
* Patient under guardianship or curatorship
* Patient not affiliated to health care system
Following of Myeloid-derived Suppressor Cells (MDSC) in Severe Sepsis: What Relationship With Systemic Inflammatory Syndrome?

Sepsis remains a major cause of death in developed countries. A better understanding of the mechanisms involved in the regulation of inflammatory and immune response of patients with severe sepsis is an important step that could open the way for new therapeutic approaches.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥18 years old
* Patient with two criteria of systemic inflammatory response syndrome and one of the four following criteria within 24 hours of hospitalization in ICU:

  * Lactate \>4 mmol/L
  * PaO2 / FiO2 \<200 in the presence of lung disease as infectious source
  * Vasopressor: adrenaline or noradrenaline ≥0.25 µg/kg/min for at least 6 hours to maintain a systolic blood pressure ≥90 mmHg or mean arterial pressure ≥65 mmHg
  * Thrombocytopenia linked to sepsis with platelet count \<100,000 / ml or a decrease ≤50% within 48 hours

Exclusion Criteria:

* Pregnancy
* progressive solid cancer
* HIV infection
* History of blood or inflammatory disease
* long-term immunosuppressive treatment
* Prior episode of Sepsis in the previous month
* Chronic Dialysis Patient
* Patient under guardianship
* Patient not affiliated with a social security system
Use Of Valproid Acid To Treat Tropical Spastic Paraparesis/HTLV-1-Associated Myelopathy (TSP/HAM)

Is the valproic acid efficacy to treat TSP/HAM


Eligibility Criteria:
Inclusion Criteria:

* HTLV-1; TSP/HAM fulfill criteria

Exclusion Criteria:

* Age \<18 years
Methods of Improvement Adherence With Therapy in Ulcerative Colitis.

Ulcerative Colitis is associated with a significantly increased risk of colorectal cancer. This risk can be reduced through regular medication with 5ASA compounds. Their effectiveness however is limited by poor adherence to the treatment protocols by many patients.

The hypothesis which underlies this proposal is that if the factors responsible for poor compliance can be identified, interventions could be developed which would help to overcome the barriers which exist in individual patients. These interventions would be based on the reasons for non-adherence, specifically tailored to the needs of the individual. As a result such interventions will improve patients' adherence with prescribed 5ASA and therefore reduce the relapses of the disease and a cancer risk.

Poor adherence to treatment is well recognised and significantly contributes to treatment failures. In ulcerative colitis it may be associated with an increased risk of colorectal cancer. Estimates for non-adherence range from 15% to 93% with an average of around a third of patients failing to adhere to their recommended therapeutic regimen.

The study aims to evaluate a wide-ranging approach to reducing poor adherence, which is based on factors associated with non-adherence and involves the patient in choosing interventions.

The effectiveness of the overall intervention will be assessed through a randomised controlled trial comparing intervention against standard care.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18-80.
* Those in whom a diagnosis of ulcerative colitis is based on histological confirmation of the disease.
* Patients who are on daily maintenance therapy with 5 ASA medication.
* Patients who have read the information leaflet and voluntarily given informed consent.

Exclusion Criteria:

* Those aged under 18 years old.
* Those with a diagnosis of Crohn's disease.
* Patients not on regular 5ASA compound as maintenance therapy.
* Patients unable to give informed consent.
* Patients who do not wish to participate in the study.
Tobacco Quitlines:Adjunct to Dental Office Tobacco Intervention

The purpose of the study is to compare two methods for providing brief dental office-based interventions designed to help patients quit either cigarette smoking or smokeless tobacco use, and to compare these two dental office-based interventions with usual care. This trial will evaluate the effectiveness of a unique combination of dental office intervention plus referral to the telephone help line, both of which have been demonstrated to be effective interventions for tobacco cessation. The integration of two lines of research-dental office interventions and telephone help line effectiveness-led us to propose this clinical trial as a more efficient and disseminable model of both training and practice.

Although many dental practitioners now routinely incorporate the first two of the "5A's" (Ask and Advise) into their practice, and previous research indicates that brief office-based interventions are effective in producing modest tobacco quit rates for dental patients, dental practitioners continue to perceive a number of obstacles to routine provision of tobacco cessation services. Many dental practitioners still believe that counseling patients to quit an addictive behavior is beyond the scope of their training or comfort.

Recent studies have shown that proactive phone counseling from State-sponsored telephone tobacco help lines has a positive effect on tobacco cessation. The use of these help lines offers a unique supplement to the dental professional that could reduce the burden on practitioner and enhance the likelihood of their patients' quitting. Referral to a specialist is within the common heuristic followed by dental and medical practitioners. Therefore, we believe referral to a telephone help line may be an innovative way of enabling dentists and dental hygienists to encourage and support their patients to quit tobacco.

We will test two levels of intervention as compared to usual care in a randomized clinical trial in which 60 dental practices in Mississippi are randomized to one of three conditions. In one condition ("5A's"), the dental team will provide a brief office-based intervention that is modeled on the "5A's" advocated by the Clinical Practice Guideline. In the second condition ("3A's" + THL), the dental team will provide the first three "A's" (Ask, Advise, Assess), and then refer patients to the State-supported telephone help line for provision of the cessation counseling and follow-up support. In the third condition (Usual Care), volunteering practices will ask their patients only to complete our study surveys.

Eligibility Criteria:
Inclusion Criteria:

* Adult tobacco-using dental patients, aged 18 and older who come in for a regularly scheduled visit to a dentist or dental hygienist participating in our study.
* Dentists in private practice, employing at least one dental hygienist and one dental assistant.

Exclusion Criteria:

* Dental patients under the age of 18
Anatomy Study in Control Nerve From Normal Human

1. To explore the pathology of nerve, vasculature in the normal control nerve
2. Compare the pathology of control nerve and nerve from amputated limb of diabetes

Diabetic foot occurs in 15% of diabetic population (3) and 15% of the diabetic foot patients end up with lower limb amputation. Peripheral neuropathy (sensory, motor and autonomic), peripheral vascular disease, trauma, infection and poor wound healing all contribute to diabetic foot problem.

Peripheral neuropathy could be evaluated in a variety of ways, including vibratory thresholds, thermal thresholds, pressure perception thresholds, muscle strength. All these predict foot ulceration to some degree(1). Motor nerve conduction velocity is an independent predictor for the development of new foot ulcer in diabetic population.

For more detailed structural study of neuropathy in diabetic patient, we could use skin biopsy method. Skin biopsy with PGP9.5 immunohistochemistry has been demonstrated by ultrastructural studies to label the terminal portions of both small myelinated and unmyelinated nerve in the epidermis (5). Intra-epidermal nerve fiber (IENF) density is reduced in patient with impaired glucose tolerance and clinically overt diabetes (5). Previous IENF density study was performed in diabetic patients with sensory symptom but no foot ulcer. Now we tried to evaluate IENF density in severe diabetic foot patient who received below knee amputation. Skin biopsy will be performed at amputated leg. The skin biopsy area will be located at lateral side of distal leg, 10 cm above the lateral malleolus as previous protocol of our group (6). Underlying sural nerve and posterior tibial nerve will be also harvested for further ultra-structural study.

We had previous IRB for "Pathology of skin, nerve and vasculature in the amputated limb of diabetes". However, pathology of normal control nerve is important to compare the pathology of nerve from amputated limb of diabetes. For parotid cancer patients receiving radical parotidectomy, facial nerve is frequently sacrificed. Sural nerve is frequently harvested for reconstruction. Sural nerve is also frequently used in ther nerve construction surgery. During these operations, we could harvested 2 cm more sural nerve for normal nerve pathology study. For cadaveric donor patient, we also could harvest normal nerve for control study.

Eligibility Criteria:
Inclusion Criteria:

* Cadaveric donor
* Patients receiving nerve graft operation

Exclusion Criteria:

* Patient with neurologic disease