cyrilzakka/clinical-trials huggingface dataset:
Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends

This pilot study evaluates the tolerability and feasibility of the Axoguard Large-Diameter Nerve Cap (sizes 5-7 mm) for protecting and preserving terminated nerve endings after limb trauma or amputation when immediate attention to the nerve injuries is not possible.


Eligibility Criteria:
Inclusion Criteria: Potential Subjects MUST:

1. Sign and date an IRB-approved written Informed Consent Form prior to initiation of any study procedures;
2. Be an adult male or female ≥ 18 and ≤ 80 years of age;
3. Present for surgery with either:

   1. Limb trauma and/or planned amputation of a limb and be candidates who are planned for a secondary nerve surgery such as Targeted Muscle Reinnervation (TMR) or Regenerative Peripheral Nerve Interface (RPNI) procedures within 6-12 months from time of amputation, or;
   2. A previous amputation and be undergoing surgery to address nerve ends;
4. Have at least one nerve end measuring greater than 4 mm and less than 7 mm in diameter after debridement and hemostasis of the proximal nerve stump;
5. Have sufficient soft tissue available to be adequately covered by the Axoguard Nerve Cap;
6. Be willing and able to comply with all aspects of the treatment and follow-up assessments and to return for all required study visits throughout the study duration.

Exclusion Criteria: Potential Subjects MUST NOT:

1. Currently undergoing or are expected to undergo treatment with chemotherapy, radiation therapy, or other known treatment that affects the growth of neural and/or vascular tissues;
2. Have signs and symptoms of chemotherapy-induced peripheral neuropathy from previous chemotherapy;
3. Be immunosuppressed or have planned immunosuppressive therapy during the duration of the study;
4. Current uncontrolled local or systemic infection as indicated by positive blood culture or other pathological indicators of infection;
5. Be contraindicated for soft tissue implants. This includes but is not limited to any pathology that would limit the blood supply to the target area or otherwise compromise healing;
6. Have a life expectancy of less than 15-months;
7. Have a history of or be planning to undergo radiotherapy in the area of the end-neuroma;
8. Have bony exostosis of the affected limb that is not treated at the time of nerve cap placement;
9. Have uncontrolled Type 1 or Type 2 Diabetes Mellitus with HbA1c of 8% or greater or those with diabetic neuropathy in the target area or proximal to the amputation site;
10. Have a history of idiopathic neuropathy/radiculopathy, known sciatica or chronic back pain;
11. Documented history of centralized nerve pain that does not respond to a peripheral nerve block in the affected limb;
12. Have a known allergy to anesthetic agents;
13. Have a known sensitivity to porcine-derived products;
14. Be currently enrolled or have been enrolled in another interventional clinical research study within the past 30 days (at time of consent); or
15. Be deemed unsuitable for inclusion in the study at the discretion of the investigator.
Performance of Acquisition Automation of Cardiac MRI

For this study, cardiac MRI examinations performed will be prospectively included and realized either fully automatically or by a specialized radiology technician. The duration of the automated examinations will be compared to the duration of the manual examinations. The number of failed sequences in both study arms (automated and manual) will be recorded and the quality of the cardiac planes will be compared.

The main hypothesis is that fully automated cardiac MRI protocols require shorter overall scan times than manually acquired, human-executed protocols. The objective will be to demonstrate that automating the examination allows to shorten the scan time, leading to increased patient comfort and clinical flexibility. The study's secondary objective will be to demonstrate the non-inferiority of the automated protocol compared to human acquisition in terms of resulting planning quality and error occurrence during slice planning.

Included patients will undergo clinical cMRI following international and national standards: only the acquisition strategy will vary. The investigators will successively recruit patients presenting for routine cardiac MRI. The acquisition strategy of the MRI - either automated or manual - will alternate to avoid comparison bias.

The MRI protocol will be the same for both arms and consists of standardized sequences acquired before and after contrast administration. Recruitment will be performed at a single location, in the radiology department. Patients will be recruited on a daily, consecutive basis during clinical practice.

No questionnaire will be used for this study. No biological material will be sampled. Observational data about the acquisition process, potential errors, and patient characteristics will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient presenting for morphologic and functional assessment of the myocardium by cardiac MRI.
* Research consent form obtained after information procedure.
* Complete cardiac MRI protocol performed.

Exclusion Criteria:

* Patients unable to provide informed consent.
* Implantable cardiac device
* Incomplete cardiac examination due to early termination by the patient.
* Incomplete data on examination parameters (missing forms).
* Incompatible MRI protocol
Time-restricted Feeding as a Dietary Strategy Against Metabolic Disturbances in Humans

This human dietary intervention study with a cross-over design aims to compare the effects of two isocaloric diets - early time-restricted feeding (TRF) vs. late TRF - on glycemic control and lipid metabolism in overweight and obese women.

The participants are randomly allocated to one of two study groups: In study group (A) participants will begin with the early TRF (e-TRF) intervention. They will consume their habitual food (and the habitual daily amount of food) between 8 am and 4 pm for two weeks. After a washout-phase participants will conduct the late TRF (l-TRF) and consume their habitual food between 1 pm and 9 pm for another two weeks. Study group (B) receives the same interventions in the reversed order. Both dietary regimens will result in 8-hr eating period and 16-hr fasting period during the 24h day.

Eligibility Criteria:
Inclusion Criteria:

* BMI 25-35 kg/m²

Exclusion Criteria:

* prior diagnosis of type 1 or 2 diabetes
* weight changes \> 5% within past 3 months
* current shift work or history of shift work
* traveled across more than one time zone one month before the study
* poor quality of sleep (PSQI score\>10)
* eating disorders, food intolerance/allergy, severe indigestion
* Pregnant or breastfeeding
* severe internal or psychiatric disorders or other conditions that might influence the outcome of the study
Total Hemihepatic Vascular Exclusion in Hepatectomy in Hepatocellular Carcinoma Treatment

Total hemihepatic vascular exclusion(THHVE),completely isolates the right or left hemiliver ipsilateral to the lesion that requires resection from the systemic circulation,has the advantage of preventing backflow hemorrhage or air embolism without having to resort to caval blood flow interruption of THVE.This study is to evaluate if THHVE can raduce bleeding,reduce the incidence of complications and improve the patient's free survival and overall survival compared with hemihepatic vascular clamping and Pringle maneuver.

The amount of blood loss and blood transfusion in Hepatectomy have a detrimental effect on the prognosis for Hepatocellular carcinoma(HCC).Intraoperative bleeding remains a major concern during liver resection. The most often used hepatic vascular control methods at present are hepatic pedicle occlusion(Pringle maneuver), hemihepatic vascular clamping,segmental vascular clamping and total hepatic vascular exclusion (THVE).However,all these methods have shortcomings. Pringle maneuver cannot prevent bleeding from hepatic veins and leads to ischemia-reperfusion injury of the liver; Hemihepatic vascular clamping cannot prevent bleeding from hepatic veins as well, and from the remnant (nonoccluded) liver. THVE is a technically demanding technique that requires surgical and anesthetic expertise and may lead to hemodynamic intolerance as well as increased morbidity and hospital stay. Total hemihepatic vascular exclusion(THHVE),completely isolates the right or left hemiliver ipsilateral to the lesion that requires resection from the systemic circulation,has the advantage of preventing backflow hemorrhage or air embolism without having to resort to caval blood flow interruption of THVE.

The purpose of this study is to evaluate if THHVE can raduce bleeding,reduce the incidence of complications and improve the patient's free survival and overall survival compared with other occlusion methods.

Eligibility Criteria:
5Inclusion Criteria:

* Understanding and being willing to sigh the informed consent form.
* Aged 18-75years.
* Corresponding to diagnostic standards of HCC, without any adjuvant therapy,tumor or multiple tumors located in right or left liver lobe.
* The function of heart, lung ,renal is well,without any surgery contraindication.
* KPS score≥60分
* Liver function in the Child-Pugh classification is A or B.
* Tumor AJCC stage isⅠorⅡ.

Exclusion Criteria:

* cannot be follow-up
* liver function in the Child-Pugh classification is C.
* with tumor thrombus in the hepatic vein or main trunk of portal vein
* with extrahepatic metastasis
Effects of Bupivacaine and Levobupivacaine on Cerebral Oxygenation During Intrathecal Anesthesia in Elderly Patients

Elderly patients with hip fracture are frail due to associated comorbidity. In these situations, regional anesthesia is recommended as it is associated to less postoperative cognitive dysfunction. However, hypotension during the process may impair ischemic cardiopathy and induce a cerebrovascular stroke. Selection of the right anesthetic agent and the administration of vasoactive drugs during the process can minimize these risks. Although bupivacaine and levobupivacaine share pharmacokinetic and pharmacodynamic properties, the studies show conflicting results. The aim of this study is to investigate if there are clinically relevant differences between these two drugs in terms of hemodynamic parameters during the surgical process with special focus on the effects on regional cerebral oximetry and cognitive status after surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 70 years old who undergo major surgery for hip fracture and will receive intrathecal anesthesia
2. Patients in which it is considered adequate, according to the usual clinical practice, the use of bupivacaine or levobupivacaine as part of the intrathecal anesthesia
3. Patients who give their informed consent to participate in the study

Exclusion Criteria:

1. Patients allergic to anesthetic drugs to be used in the protocol or to local anesthetics amida type.
2. Patients with severe aortic stenosis or hemodynamic instability.
3. Patients who refuse the anesthetic technique or contraindication for the use of the intrathecal technique.
4. Patients with severe cognitive impairment previous to the intervention (defined by a score in the Pfeiffer test of 8-10 errors)
5. Patients in which the use of bupivacaine or levobupivacaine is contraindicated as part of the intrathecal anesthesia
6. Any condition that, in the investigator's opinion, could pose a risk to the patient
Keratoconus Detection Using MS39 and Pentacam

This retrospective study aims to investigate whether the MS39 and Pentacam are delivering comparable results in the diagnosis of keratoconus.

In the future, these measurement devices could be interchangeable in usage.

Keratoconus is a degenerative pathology of the cornea, which tends to progress. It comes along with central and paracentral thinning of the cornea as well as with an apical protrusion of the cornea. Keratoconus leads to vision loss. This pathology is diagnosed by using CE certified OCT technology in order to map the topography of the cornea. This process constitutes a really important step in the line of management of the keratoconus. MS39 and Pentacam are used for detection. Retrospectively, data will be investigated, in order to see if these measurement devices deliver comparable results. In the future, these measurement devices could be interchangeable in usage.

Eligibility Criteria:
Inclusion Criteria:

* age older than 14 years
* patients who show up at Keratokonus consultation hours

Exclusion Criteria:

* age younger than 14 years
* age older than 100 years
A Study to Assess Overall Survival and Treatment Patterns for Advanced Liver Cancer Participants Who Received Nivolumab Therapy

A study to describe real-world treatment patterns and overall survival in advanced liver cancer participants who received second or third line nivolumab therapy

The central aims of this study are descriptive and designed to describe the patient demographics, clinical characteristics, treatment patterns, and overall survival in advanced liver cancer participants who received second or third line nivolumab therapy in the real-world setting.

Eligibility Criteria:
Inclusion Criteria:

* Adult aHCC participants in the Flatiron database as defined by:
* Diagnosed with HCC International Classification of Diseases (ICD)-9 155.x or ICD-10 C22.x)
* Pathology consistent with advanced HCC
* Age 18 years or older at index
* At least two clinic encounters on different days in the Flatiron database occurring on or after January 1, 2011
* Participants who received second or third line nivolumab monotherapy or combination therapy for aHCC

Exclusion Criteria:

* Participants with \<1 month of medical data (any clinic visits, medication administrations or oral medication prescriptions) following and including the index date
* Participants with clinical study drug during prior or post study index periods

Other protocol-defined inclusion/exclusion criteria could apply
A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome

The purpose of this study is to determine whether antibiotics given immediately after birth alter the development of the developing preterm infant's microbiome, which may further alter overall clinical outcomes.


Eligibility Criteria:
Inclusion Criteria for antibiotic randomization:

1. Infant must be born between the gestational ages of 28 0/7 weeks and 34 6/7 weeks

   -AND-
2. Infant must be born at investigator's home institution.

   -AND-
3. Infant must be considered to have a low risk of infection by one of the following criteria:

   1. Delivered for maternal indications (Cesarean section or induction of labor for maternal health, including pre-eclampsia, placental abruption, history of intrauterine fetal demise (IUFD)/abruption, multiple gestation requiring preterm delivery, etc) -OR-
   2. Delivered due to preterm labor to a mother without the diagnosis of chorioamnionitis/maternal fever or prolonged rupture of membranes \>18 hours

Exclusion Criteria for antibiotic randomization:

1. Signs of clinical illness within the first 3 hours of life:

   1. 5-minute Apgar \<5
   2. Requiring vasoactive drugs
   3. Seizures
   4. Significant respiratory distress requiring supplemental oxygen \>40%
2. Immature:Total (I:T) Ratio of \>0.2 on initial complete blood count (CBC)
3. Congenital anomalies, including renal anomalies requiring serum antibiotic level monitoring

ANY infant born between the gestational ages of 28 0/7 weeks and 34 6/7 weeks who do not meet inclusion criteria, with parental consent, can participate in the stool analysis only arm of the study.
Remimazolam and Scoliosis Orthopedics

Spinal cord injury is one of the most dangerous complications of scoliosis orthopedic surgery, and the Stagnara awakening test has been used in orthopedic spine surgery and is considered the "gold standard" for detecting spinal cord injury. During the awakening test, the patient is awakened from anesthesia and, in conjunction with a neurological assessment, moves his or her fingers and toes to determine the integrity of spinal cord motor function in order to avoid spinal cord injury. During this procedure, the patient still requires a degree of sedation and analgesia to tolerate tracheal intubation and surgical pain. Remazolam benzoate for injection is a new class of benzodiazepines that are ultra-short-acting sedative/anesthetic drugs. It has the advantages of rapid onset, rapid elimination, and no drug accumulation by continuous infusion, and has the advantage of being applied to wake up during spinal orthopedic surgery, but its effectiveness and safety are still unclear. This study aims to elucidate the safety and efficacy of rimazolam benzoate for injection for arousal in spinal orthopedic surgery through a single-center, randomized, single-blind, positive drug-controlled trial, with the aim of providing a basis for the development of a safe and effective anesthetic protocol for such surgery.


Eligibility Criteria:
Criteria:

Inclusion Criteria:

1. Age greater than 18 years and less than 60 years
2. Elective scoliosis orthopaedic surgery under general anesthesia.
3. ASA Physical Score I-III
4. Signed informed consent.

Exclusion Criteria:

1. Patients who cannot understand the method and requirements of the arousal test and cannot cooperate in completing the arousal test.
2. Patients with limb sensory-motor dysfunction.
3. Patients with a history of severe neurological disorders.
4. Patients with psychiatric disorders.
5. Patients who have taken benzodiazepines and/or opioids daily for one month or intermittently for the last three months.
6. Patients with concomitant severe respiratory and circulatory disorders, including acute heart failure, unstable angina, resting ECG heart rate \<50 beats/min, QTc: ≥ 470ms in men and ≥ 480ms in women, third-degree AV block, severe arrhythmia, moderate to severe heart valve disease, chronic obstructive pulmonary disease, and history of asthma.
7. Abnormal liver and kidney function: ALT and/or AST exceeding 2.5 times the upper limit of the medical reference range; urea or urea nitrogen ≥1.5 × ULN, blood creatinine greater than the upper limit of normal values.
Phosphodiesterase 4 Gene Variant and Salbutamol Response in Persistent Childhood Asthma

This study is designed to investigate whether the Phosphodiesterase 4 gene variability could be implicated in the salbutamol responsiveness in asthmatic children.

Patients from 6 to 18 years old with asthma and receiving a treatment by salbutamol according to the usual care will be recruited. Saliva from patients will be collected using Oragen®.DNA OG-575 kit.

Eligibility Criteria:
Inclusion Criteria:

* Children 6-18 years
* Asthma: confirmed asthma symptoms (wheeze, cough, dyspnea, chest tightness) and evidence for variable airflow limitation (≥ 12% increase in post bronchodilator FEV1, or ≥ 20% decrease in FEV1 post methacholine)
* Spirometry prescribed for follow-up
* Airflow limitation: FEV1\<80% and/or FEV1/FVC \<80 pre-bronchodilator

Exclusion Criteria:

* no exclusion criteria
Study of the Functional Effects of Nusinersen in 5q-spinal Muscular Amyotrophy Adults (SMA Type 2 or 3 Forms)

Spinal Muscular Atrophy (SMA) is an autosomal recessive disease caused by a mutation of exon 7, in 95% of cases, encoding the gene for the motor neuron survival protein called SMN1 (Survival Motor Neuron) located on chromosome 5q. Patients with an SMA-5q mutation suffer from progressive muscle deficiency and subsequent atrophy induced by degeneration of motor neurons in the spinal cord. Gene therapy is now available for the management of spinal muscular atrophy and nusinersen is the first approved treatment. Nusinersen has been granted marketing authorization in France since May 30, 2017. Nusinersen has a high level of medical service rendered (MSR) for types I, II, and III, but the improvement in medical service rendered (IMSR) is assessed as moderate for types I and II. For Type III, IMSR is not known.

The aim of the study will be to evaluate the impact on functional motor abilities of intrathecally-injected nusinersen in adult 5q-SMA type 2 and type 3 persons.

If the efficacy of nusinersen protocol will demonstrate the positive impact for patient's, the results of this study would promote an improvement in the medical service rendered in this population in terms of disease stabilization, maintenance of functional capacities and social participation.

Eligibility Criteria:
inclusion criteria :

* Adults (over 18 years of age)
* 5q-SMA type 2 or 3
* with indication for nusinersen treatment by the physician of the center of reference and competence for neuromuscular diseases
* accepting treatment by nusinersen
* Agreeing to participate in the study (signature of the informed consent form).
* living within a radius of 40 km of the investigation center (for logistical reasons related to the conduct of assessments in the patient's home).
* affiliated to a social security system.

exclusion criteria :

* minors (less than 18 years of age)
* with a contra-indication to the nusinersen: pregnancy, breast feeding, hypersensitivity to the nusinersen
* with a contraindication to lumbar puncture: hemostasis disorder, intracerebral mass
* benefiting from another gene therapy drug to treat spinal muscular atrophy.
Searching for Predictive Biomarkers of Efficacy in Small Cell Lung Cancer Patients Treated With Chemotherapy-immunotherapy Combination Using Imaging Mass Cytometry (HYPE)

The goal of this retrospective study is to identify predictive biomarkers of efficacy in tumor samples of small cell lung cancer patients treated with chemotherapy-immunotherapy combination using imaging mass cytometry. The main question it aims to answer is: is there any feature in the tumour microenvironment that can discriminate responders from non responders before treatment? Participants will provide consent for the collection of their clinical data and the study of their tumor samples

Small cell lung cancer patients treated with first-line atezolizumab plus platinum-etoposide regimen with available formalin fixed paraffin embedded (FFPE) biopsies at baseline will be identified from Brest University Hospital medical records and their samples will be retrieved from Brest University Hospital Pathology Laboratory for imaging mass cytometry analyses.

Clinical data will be collected for each patient, including progression-free survival (defined as the time between treatment start and date of progression according to investigator, or death from any cause) and overall survival (defined as the time between treatment start and date of death from any cause).

For imaging mass cytometry analyses, a panel of 39 metal-tagged antibodies will be used to characterize the cell composition of lung tumors at baseline (inflammatory, tumor and stromal cells).

Statistical analyses will be performed to correlate the composition of the tumor microenvironment at baseline and the survival data.

Eligibility Criteria:
Inclusion Criteria:

* Patients with extensive or metastatic small cell lung cancer
* Patients who started a first line treatment with atezolizumab plus carboplatin and etoposide in routine practice before February 2021
* Patients with available tumor sample before treatment start
* No objection from living patients

Exclusion Criteria:

* Patients who started first line treatment with atezolizumab plus carboplatin and etoposide in routine practice after February 2021
* Patients having received immunotherapy in a clinical trial
* Patients with auto-immune disorder
* Patients under legal protection (guardianship, curatorship)
* Patients refusing to participate to the study